Vasculab Journal of Theoretical and Applied Vascular Research (page 1) - JTAVR 2018;3(1)

Editorial Board

N. 01-2018 Feb, year 3

Journal of Theoretical and Applied Vascular Research

Online ISSN 2532-0831 DOI: https://doi.org/10.24019/issn.2532-0831

A Journal on Research in Vascular Diseases, published three times a year

The Official Journal of the Vasculab Foundation Editor-in-Chief

Fausto Passariello Editorial Board

Basic Sciences, Biology and Medicine

Giovanni Agus, Francesco Albergati, Claudio Allegra, Pier Luigi Antignani, Malika Boucelma, Alberto Caggiati, Massimo Cappelli, Mariella Catalano, Domenico Corda, Stefano Ermini, Andrea Fontanella, Claude Franceschi, Giorgio Guarnera, Arkadiusz Jawien, Mark Malouf, Ferdinando Mannello, Sandro Michelini, Waldemar Lech Olszewski, Fausto Passariello, Malay Patel, Neil Piller, Angelo Scuderi, Massimo Vaghi, Carolina Weller History and Philosophy of Science

Alessandra Passariello Non-animal experiments

Alessandra Passariello, Fausto Passariello Editorial office, imagine and communication

Iolanda Palma - [email protected] Operative Executive Board

Iolanda Palma, Alessandra Passariello, Fausto Passariello Web Authoring

HTML, XML, XSLT, XSL-FO, Javascript, PHP, MySql, LATEX programming by Fausto Passariello Online editing, graphics and advertisement, marketing

Aquarius s.r.l. Cover

digital image, editing by Iolanda Palma. Editor

Fondazione Vasculab impresa sociale ONLUS, Via Francesco Cilea, 280 - 80127 Napoli - Tel/Fax +39 081 7144110 - [email protected] - https://doi.org/10.24019/issn.2532-0831 Pubblicazione quadrimestrale online. Autorizzazione del Tribunale di Napoli, n. 45 del 12 ottobre 2016. Anno 3 - N. 1.

Direttore responsabile: Dott. Fausto Passariello

Vasculab Journal of Theoretical and Applied Vascular Research (page 3) - JTAVR 2018;3(1)

Editorial Lines

Non-animal experiments

Many scientific journals deal with animal experiments, but just a few of them face the hard problem of animal replacing or sacrifice/suffer reducing or minimizing, together with the related ethical and legal topics.

Since the 1st issue, the Journal of Theoretical and Applied Vascular Research (JTAVR) hosted papers devoted to the methodology for non-animal experiments. JTAVR is open to the discussion about the controversies inside the community of biomedical researchers, i.e. between people who use animals as an unavoidable experimental tool and others which on the contrary point to different research methods.

However, a-priori positions pro or contra total animal replacement in biomedical research do not correspond at all to reality, because the solution is anchored to the ground, it is context dependent and is hidden behind a detailed study of the experiments, aimed to provide a reliable response.

An answer which must not be black or white and must consider instead any involved methodological detail. In addition, there is the strong hope that many actions which were never done will be successful instead in the next future. For instance, consider the unexpected new frontier which in the last years turned up in the field of the organ-on-a-chip technology.

Maybe, not so far in the future, this contra opposition will be seen just as a nonsense. History and Philosophy of Science

Working Basic Sciences, Biology and Medicine

The Journal of Theoretical and Applied Vascular Research (JTAVR) aims at gathering contributes to vascular research, coming from biology, medicine, and basic sciences like physics, fluid dynamics and bioengineering as well as biochemistry and genetics.

A special attention is given to the cultural aspects behind medical daily work, like models, epistemology, philosophy and history.

This inter-disciplinary approach uses a wider eye/chakra, placing side by side topics which generally could never go together in medical journals, with the hope that it will succeed in producing new interesting fruits in research. Editor

Fondazione Vasculab impresa sociale ONLUS, Via Francesco Cilea, 280 - 80127 Napoli - Tel/Fax +39 081 7144110 - [email protected] - https://doi.org/10.24019/issn.2532-0831

Vasculab Journal of Theoretical and Applied Vascular Research (page 5) - JTAVR 2018;3(1)

Vascular News

VASCULAR NEWS NEWS Vascular News

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

It is an author’s experience work to guide medical student, radiological technician and technologist to ease the path of understanding the vascular concepts and technique, Doppler and duplex uses, type of procedures that involved in all vascular aspects in order to give a brief, easy explanation for new students.

Index - Basic physics - Artefacts in Doppler techniques - Doppler examination - ABI and TP - RBI and FP - Arterio Venous Fistula - Duplex examination - Ultrasound equipment - Upper limp arteries - Lower limb

Linda Moh’d Al-wabil - Supervisor of ultrasound in dr. Suliman alhabib medical hospital, ArRyan branch, Riyadh, Saudi Arabia. - First Vascular Technologist Saudi female In Vascular Laboratory In King Khalid University hospital, In Saudi Arabia. - Master degree in Health Care Administration ABC of Vascular Laboratory and BSc of radiological sciences. Experience in ultrasound and mammography. This book is a manual note of vascular protocol - Member of Zahra Brest Cancer Association in in Vascular Laboratory, King Khalid University Hospital. Saudi Arabia. Saudi Arabia.

SIMV The extreme openness of the Society of Vascular Medicine is aimed at welcoming all those which in The Society of Vascular Medicine was finally born any way, in the context of specific attributions and in Italy on May 2019 in Rome on the initiative of a group disciplines, are interested and involved in the problems of medical area professionals ! in the same way than in the of vascular pathology from the medical point of view United Sates (SVM since 1989) and in Europe (ESVM since and in the overall management of vascular diseases, 2014) assuming that the assistance offered to patients can be better achieved by collegial interaction and by the collaboration The Italian Society of Vascular Medicine (SIMV of a community of vascular professionals, pointing out www.simv.eu) is a transversal multi-specialist professional no-profit association.

Vasculab Journal of Theoretical and Applied Vascular Research (page 7) - JTAVR 2018;3(1) Vascular News the importance of people with different backgrounds in The Association aims to improve the knowledge of achieving ideal standards of research and clinical practice. diseases of the vascular system, their care and related diagnostics (instrumental and laboratory) and aims to bring The Association's goals are to improve the integration together all those who are dedicated to the study of of vascular biological advances in medical practice and to physiology, pathophysiology, pathology of the vascular maintain high standards of clinical vascular medicine. system and related diagnostic and clinico-therapeutic aspects, facilitating relations between experts in the field inside their own association and establishing relationships with other scientific national and international associations (mostly Vascular Surgery). The Founders are convinced that without a thorough understand of the aetiology, pathophysiology and natural history of the disease, as well as a knowledge of medical, surgical and interventional technologies, care for the patient with vascular disease will be less than optimal.

Vasculab Journal of Theoretical and Applied Vascular Research (page 8) - JTAVR 2018;3(1) INSTRUCTIONS TO AUTHORS

non-commercial use on their personal or non-commercial institution's The Journal of Theoretical and Applied Vascular website. Research (JTAVR) publishes scientific papers on vascular diseases, biological research, history and philosophy of Commercial use science. No articles from the JTAVR website may be reproduced, in any media or format, or linked to for any commercial purpose (eg. product support, etc) without the prior written consent of JTAVR and payment to JTAVR of an appropriate fee. Publication fees

Initial publications of JTAVR (up to presumably one year) are free of charge for invited Authors and for the members or supporters of the Vasculab Foundation. For the Vasculab Foundation membership see www.vasculab.eu. Article types Manuscripts are expected to comply with the instructions to authors which conform to the Uniform Editorials, original articles, review articles, systematic reviews and meta-analyses, randomised controlled trials, research protocols, Requirements for Manuscripts Submitted to Biomedical original case reports, case series, therapeutical notes, clinical images, Editors by the International Committee of Medical Journal clinical videos, letters to the Editor, guidelines, special articles (like Editors (www.icmje.org/). history and philosophy of science), invited sessions, reprints of historical papers of actual interest. Submission of manuscripts In order to submit an article online, follow the step by step Papers should be submitted directly online to the instructions at www.vasculab.eu/jtavr/submissions.htm Editorial Office at the Fondazione Vasculab ONLUS Preparation of manuscripts website: www.vasculab.eu/jtavr/submissions.htm Footnotes or endnotes The journal adheres to the principles of the Helsinki Declaration (http://history.nih.gov/research/downloads/ JTAVR does not encourage the use of footnotes. Generally, they helsinki.pdf) about research concerning human beings and are not used in medical journals, but they are tolerated, especially in to the International Guiding Principles for Biomedical articles in the field of history and philosophy. Footnotes or endnotes must be quoted in Low Caps Romans in rectangular brackets (example: Research Involving Animals (http://cioms.ch/publications/ [iv] guidelines/1985_texts_of_guidelines.htm) recommended [iv] and cited as ). by the WHO. In addition, the journal strongly supports References alternative non-animal experiments, in order to Replace, Reduce and Refine (3Rs) animal experimental designs. - Only cited references can be included in the bibliography. They For complete information about publication terms must be numbered in Arabic numerals, in the exact sequence as they are firstly cited (example: "1)"). please contact the Editorial Office of JTAVR, Fondazione Vasculab impresa sociale ONLUS, via Francesco - Bibliographical entries in the text should be quoted using Cilea 280 Italy - Phone +39-081-7144110 - E-mail: superscripted Arabic numerals (cited as1). [email protected]. - References must be set out in the standard format approved by the International Committee of Medical Journal Editors (ICMJE), Open Access Publication as described in the document Recommendations for the Conduct, All manuscripts submitted to JTAVR are assumed to be Reporting, Editing, and Publication of Scholarly work in Medical submitted under the Open Access publishing model. In this publishing Journals http://www.icmje.org/icmje-recommendations.pdf. model, papers are peer-reviewed in the normal way under editorial A simplified but comprehensive list is given in control. Submission and reviewing process are not charged. When a www.nlm.nih.gov/bsd/uniform_requirements.html. paper is accepted for publication the author is issued with an invoice for payment of a publication processing fee (see www.vasculab.eu/ Citation examples jtavr.xml). Payment of this charge allows JTAVR to recover its editorial and production costs and create a pool of funds that can be used to provide fee waivers for selected authors, for instance for invited authors, Standard journal article authors of papers on history and philosophy of science and for authors from lesser developed countries (see below). List the first six authors followed by et al.

Halpern SD, Ubel PA, Caplan AL. Solid-organ transplantation in HIV- Free download infected patients. N Engl J Med. 2002 Jul 25;347(4):284-7.

Published papers appear electronically and are freely available As an option, if a journal carries continuous pagination throughout a volume from our website. Authors may also use their published .pdf's for any (as many medical journals do) the month and issue number may be omitted.

Vasculab Journal of Theoretical and Applied Vascular Research (page 9) - JTAVR 2018;3(1) INSTRUCTIONS TO AUTHORS

Halpern SD, Ubel PA, Caplan AL. Solid-organ transplantation in HIV- messages/# Accessed on line on 'date of last access'. A (free) subscription to Vasculab infected patients. N Engl J Med. 2002;347:284-7. is required.

Books and Monographs Historical monographs

The format will be specified in next future. Author(s) and editor(s) File of tables Breedlove GK, Schorfheide AM. Adolescent pregnancy. 2nd ed. Wieczorek RR, editor. White Plains (NY): March of Dimes Education Services; 2001. Each table should be submitted as a separate file. Formats accepted are .doc and .rtf. Each table must be numbered in Roman numerals and accompanied by the Chapter in a book relevant title. Notes should be inserted at the foot of the table and not in the title. Tables should be referenced in the text sequentially. Meltzer PS, Kallioniemi A, Trent JM. Chromosome alterations in human solid tumors. In: Vogelstein B, Kinzler KW, editors. The genetic basis of human File of figures cancer. New York: McGraw-Hill; 2002. p. 93-113. Each figure should be submitted as a separate file. Formats accepted: JPEG Electronic materials set at 300 dpi resolution preferred; other formats accepted are TIFF and PNG. Figures should be numbered in Arabic numerals and accompanied by the relevant title. Figures should be referenced in the text sequentially.

Homepage/Web site Histological photographs should always be accompanied by the magnification ratio and the staining method.

Cancer-Pain.org [Internet]. New York: Association of Cancer Color illustrations Online Resources, Inc.; c2000-01 [updated 2002 May 16; cited 2002 Jul 9]. Available from: http://www.cancer-pain.org/. Open Access papers appear electronically. As no printed issues of JTAVR Vasculab mailing list are produced there are NO additional charges for color illustrations. However consider that many people will print them in black and white. Thus Provided you know the number '#' of the message, the format of the citation for a better result in communicating your data, test also the black and white printing here follows, where the date of the last access is required (following the Vancouver when choosing colors. style) and the symbol '#' must be replaced with the effective number of the message:

Author(s) name(s). Vasculab Yahoo Groups. The Vascular List. Message '#'. https://it.groups.yahoo.com/neo/groups/vasculab/conversations/

Vasculab Journal of Theoretical and Applied Vascular Research (page 10) - JTAVR 2018;3(1) F Passariello - The great and silent revolution of the units of measure

EDITORIAL The great and silent revolution of the units of measure

F Passariello1

1 Fondazione Vasculab ONLUS, via Francesco Cilea 280 - 80127 Naples, Italy

submitted: Apr 14, 2019, accepted: Apr 17, 2019, EPub Ahead of Print: Apr 18, 2019, published: Jul 7, 2019 Conflict of interest: None

DOI: 10.24019/jtavr.32 - Corresponding author:Dr. Fausto Passariello, [email protected]

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

Maybe just a few people know that on May 20th, 2019 founded in 1794 by the "Abbey Grégoire", during the a global revolutionary change of the units of measure will French revolution, when the interest for the units of measure involve all human activities everywhere in the world. was firstly officially stated. No panic, please ! Nothing at all will really change in The Museum hosts also the Lavoisier chemical our daily life. laboratory and one realization of the famous Foucault Pendulum (1851), used to show the rotation of the Earth and The current revolution started in France, but almost the Coriolis effect. The exposition will be open until May all the states of the world joined the Committee (Table I). As 5th, 2019 - just fifteen days before the deadline for the new st an historical note, the 1 “Conférence Générale des Poids et 2019 SI change. Mesures” [General Conference on Weights and Measures] (CGPM)1 was held in 1899 in Paris2 while the 26th CGPM Visiting the exposition, we learn how the history th th of the civil society is weaved together with the units was organised in 2018 in Versailles Nov 13 -16 by the of measure, being unexpectedly connected to the history “Bureau Internationale des Poids et Mesures” [International of taxation. Governments have a great interest in Bureau of Weights and Measures] (BIPM), which published measurements, in order to be able to apply a certain and an a final document about the adopted resolution3. undoubted fee, according to a fixed unit of measure. In detail, the International System of Units (SI) was Here we see displayed a lot of unit devices which previously defined in 1960 with six basic units, replacing were used in the past, for instance by the Egyptians, Greeks the old CGS and MKS system[i] and was continuously and Romans to document this indissoluble relationship. updated in the following years. The current 2018 update, Other similar devices are also in exhibition from more taking effect from May 20, 2019, introduces new definitions recent epochs, like the medieval and renaissance ages. for seven basic units, which use the three universal physical The need to set a supranational standard was clearly constants G (gravitational constant), h (quantum Planck felt during the French revolution. At the time the units of constant) and c (light speed in vacuum and relativistic measure just then were scarcely precise and only locally constant). valid. It could be hypothesized that the great interest for the The differences between the current and the previous units of measure maybe rose during the French revolution definitions are summarized in Table II. in order to provide the same scientific measurements everywhere in the French Republic and for all the citizens, The echo of the current resolution reached the as intellectually required by the Enlightenment age. specialized public through articles4 and the organization of events. An interesting exhibition is currently held at Later and gradually at the end of the XIX century the “Conservatoire National des Arts et Métiers” [National all countries agreed to participate in setting a standard in measurements and joined the BIPM. Museum of Arts and Works]5,6. The Conservatoire was

Vasculab Journal of Theoretical and Applied Vascular Research (page 11) - JTAVR 2018;3(1):11-13 F Passariello - The great and silent revolution of the units of measure

International Committee for Weights and Measures (CIPM)

List of Member States

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Lithuania, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States of America, Uruguay

List of Associated States and Economies

Azerbaijan, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Botswana, Caribbean Community, Chinese Taipei, Costa Rica, Cuba, Ecuador, Estonia, Ethiopia, Georgia, Ghana, Hong Kong (China), Jamaica, Kuwait, Latvia, Luxembourg, Mauritius, Moldova (Republic of), Mongolia, Namibia, North Macedonia, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Seychelles, Sri Lanka, Sudan, Syrian Arab Republic, Tanzania (United Republic of), Uzbekistan, Viet Nam, Zambia, Zimbabwe

Table I

Coming back to more recent times, the current change However, the revolution of the units of measure in the SI is not a simple negligible update. It is an important mainly deals with high precise technical applications, while revolution instead, because several units are redefined and it does not involve any change in our ordinary daily some of them are substituted by the universal physical measure, as the length of a table, the weight and the constants. circumference of the ankle of a patient.

For instance, using the old definition of meter (based Thus, all instruments remain valid and in the same on the standard example meter made of platinum-iridium way all the usual daily procedures are still correct. and kept in Sèvres, France), the development of the Global In this sense the new SI update is a great-but-silent Positioning System (GPS) technology would never have revolution in Metrology. been possible, while it was realized using the new unit, given by the standard speed of light in vacuum. Note that in Fausto Passariello this case the velocity substitutes the length in the definition, while the basic physical quantity is still the length. Editor in Chief of JTAVR

Endnotes [i] The (centimeter, gram, second) system (CGS) was adopted only in 1940 and suddenly substituted in 1960 by the International in 1873 by the British Association for the Advancement of Science as System of Units (SI). Today, CGS and MKS survive as non-official an evolution of the previous (millimetre, milligram, second) system, systems in specialised fields of science, where several units are felt proposed in 1832 by Carl Friedrich Gauss. The CGS system was later as more practical. For instance, blood viscosity is often measured in substituted by the (meter, kilogram, second) system (MKS) during the centipoise (cP), a derived unit of the CGS system. 1st CGPM meeting in 1899. However, it was internationally accepted

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New revision of the International System of Units (SI)

Physical quantity Old unit New unit

Mass Platinum kilogram (Kg) Planck constant (h) Length Platinum meter (m) Speed of Light in vacuum (c) Time Second (s) Transition frequency of Caesium 133 atom (Cs) Electric charge Coulomb (C) Ampère per second Temperature Kelvin (K) Boltzman constant (k) Mole Mole (mol) Avogadro constant (NA) Light intensity Candela (cd) Light efficacy of a monochromatic ray (Kcd)

Table II

References 3) CGPM adopted resolutions. Available at the address https://www.bipm.org/utils/common/pdf/CGPM-2018/26th- CGPM-Resolutions.pdf accessed Apr 14, 2019. 1) 26th Conférence générale des poids et mesures (General Conference of weights and measures, CGPM), Versailles Nov 13-16, 4) BIPM brochure. Available at the address https:// 2018. Available at the address https://www.bipm.org/fr/cgpm-2018/ www.bipm.org/fr/publications/si-brochure/ accessed Apr 14, 2019. accessed Apr 14, 2019. 5) Exhibition at the “Conservatoire National des Arts et 2) Compte rendus des séances de la première conférence Métiers” [National Museum of Arts and Works], 60 rue Réaumur, générale des poids et mesures réunie à Paris en 1889 [Report of the 75003 Paris. Exposition from Oct 16, 2018 to May 5, 2019. Info at the sessions of the first general conference of weights and measures in address http://www.arts-et-metiers.net accessed Apr 14, 2019. Paris 1889]. Gauthier-Villars Ed, Paris, 1990. Available at the address https://www.bipm.org/utils/common/pdf/CGPM/CGPM1.pdf accessed 6) Les unités de mesure font leur révolution [The units Apr 14, 2019. of measure make their revolution]. CNRS Le Journal. 2018 summer;293:3-11.

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F Morganti - Animal welfare in Italy from unification to the XXI century: a recent book on the subject

NON-ANIMAL NEWS BOOK REVIEW Animal welfare in Italy from unification to the XXI century: a recent book on the subject

F Morganti1

1 Laboratorio Analisi Politiche e Sociali (LAPS), LUISS Guido Carli, Roma

submitted: Mar 26, 2019, accepted: Mar 26, 2019, EPub Ahead of Print: Apr 1, 2019, published: Jul 7, 2019

DOI: 10.24019/jtavr.62 - Corresponding author:Dr. Federico Morganti, [email protected]

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

Human concern for animal welfare – including ultimately, for the advocacy of animal rights: namely, Ente animalist thinking, animal rights activism, veganism, and nazionale per la protezione degli animali (ENPA, “National vegetarianism – has become more widespread across the Board for the Animal Protection”). western world today than it has ever been. Of course, this phenomenon did not spring out of nothing; it has The book itself was issued by ENPA publishing press. a history that dates back at least to the XIX century. Regardless of the publisher’s interest in the subject, the Thanks to the wealth made possible by the industrial choice of ENPA as focus for a history of animal protection revolution, at least some animals (not only pets, but also in Italy would still be perfectly legitimate. ENPA is in fact those involved in economic production) were no longer the oldest Italian organization for the protection of animals, (or not always) seen as mere goods for consumption, and its history is inextricably intertwined with that of many but possessors of a subjectivity – intelligence, emotions other relevant animalist and “zoophile” associations, while and, more fundamentally, the ability to perceive pain and it also influenced policy decisions on the subject over the pleasure, and thus worthy of protection. Before industrial years. revolution and the growth of national income in the Western In the first chapters we learn how the Italian interest world, not only were pets a luxury that most people could in the subject of animal welfare – even before unification not afford, but the idea of protecting “animal welfare” when (1861) – developed more or less during the same decades people could barely meet their everyday needs was much as in many other developed countries. In XIX century more problematic. England paved the way, by promulgating the first legislative acts to regulate cruelty to animals, and thanks to the Besides, it was the XIX century that saw the proliferation of publications and associations dedicated to introduction of the first forms of intensive farming, which the protection of animal welfare. The most important of began to raise ethical issues on the practice of meat these associations, the Society for the Prevention of Cruelty consumption. In addition to this, the increasing circulation to Animals (founded in 1824), was later to obtain patronage of Darwinism undoubtedly contributed to this transition from the crown and to become Royal Society in 1840. because it promoted the image of non-human animals as Soon France, Germany, Austria, Netherlands, Belgium, fellow travelers resembling mankind in more aspects than Switzerland and the United States would follow the same once suspected. steps.

The book La protezione degli animali in Italia. Storia The first law against the mistreatment of animals was dell’ENPA e dei movimenti zoofili e animalisti dalla metà introduced in the Italian penal code in 1889, which imposed 1 dell’Ottocento alle soglie del Duemila by Andrea Maori, fines on those at fault of “unnecessary abuse” toward deals with the history of animal protection in Italy by animals. As Maori suggests, the word “unnecessary” focusing on the one Italian institution that represented the introduced a certain margin of discretionality to the battle for a more humane treatment of non-humans and, judiciary because the boundaries of “necessary” infliction

Vasculab Journal of Theoretical and Applied Vascular Research (page 15) - JTAVR 2018;3(1):15-18 F Morganti - Animal welfare in Italy from unification to the XXI century: a recent book on the subject were left undefined. But more important is the question This organization was actively involved in ensuring of why the government felt it was time to crack down on public hygiene, raising awareness among the public animal mistreatment. opinion, ensuring the enforcement of existing laws, and lobbying for more incisive ones – in addition to supervising With a clearly anthropocentric outlook, far from the practice of animal experimentation (then referred to considering the point of view of the suffering animals, as “vivisection”) in universities and research labs. Yet the legislator implied that all unnecessary infliction of there was not much success these societies could achieve pain to animals was at odds with “any sense of humanity, by occasionally reporting infractions to the authorities. In of compassion, of benevolence” in the perpetrator. In general, the rise of these organizations and the development other words, what mattered was the human’s feeling when of the laws approved by the Parliament would prove very mistreating the unfortunate animal, rather than the feeling difficult to enforce, despite all the efforts. Not even those of pain in the animals themselves. As the book repeatedly associations who had been granted the title of Ente Morale makes clear, all legislative acts in defence of animals up (“Moral Association”) – i.e. patronage by the crown – could to the third quarter of the XX century would preserve employ their officers as public servants, and they were thus more or less this same spirit. The decades preceding devoid of any authority of giving fines, let alone arresting the introduction of the law had witnessed the birth of the infractor. many early protectionist associations in several Italian municipalities, but with little success, both in terms of In 1913 the Italian Parliament voted for what is public appreciation and results. One of these associations, now remembered as “Legge Luzzatti” (named after Luigi Società Torinese Protettrice degli Animali (“Turin Society Luzzatti, former Prime Minister and promoter of the for Animal Protection”, founded in 1871) was later to bill). The bill confirmed the concept of “unnecessary develop into what we know today as ENPA. torture”, thus fundamentally replicating the spirit of the former jurisprudence on the subject. More importantly, it strengthened the function of the officers employed by zoophile societies, who could now be granted the status of agenti di pubblica sicurezza (“Public Security Officers”). The bill also touched upon the thorny issue of vivisection, which it considered a “lesser evil” – i.e. a necessary instrument for scientific researchers, which was allowed, provided that it was solely performed by accredited “experts” (i.e. physicians or veterinarians). This point in particular stimulated a heated debate between animalist groups who demanded more restrictive protections of animals versus the researchers, physicians, and medical practitioners, who questioned such limitations as a de facto state monopoly on science and thus an infringement of freedom of research.

The efforts of protectionist societies was halted by the outbreak of World War I, as resources were redirected from civil society to military purposes. At this point, all protectionist societies scattered across the country were deprived of any sort of top-down coordination or long-term strategy, and their financial resources were limited. The situation changed under the Fascist regime, first thanks to the foundation of Federazione nazionale fra le Società zoofile (“National Federation of Zoophile Societies”) in 1929, and then, more radically, with the institution of ENFPA, Ente Nazionale Fascista per la Protezione degli Animali (“National Fascist Board for the Animal Protection”). All zoophile and protectionist organizations, and the National Federation itself, were at once suppressed, and their offices and duties fell under direct control and authority on ENFPA. The Fascist press emphasised respect toward animals as a civic duty, Animal Welfare in Italy. ENPA Ed., Roma 2016. overtly denying that tenderness to animals could corrode

Vasculab Journal of Theoretical and Applied Vascular Research (page 16) - JTAVR 2018;3(1):15-18 F Morganti - Animal welfare in Italy from unification to the XXI century: a recent book on the subject or weaken the “warrior spirit” of the nation. There was supervision of the Ministry of Interior, and their officers no sentimentalism in the protection of local fauna, which were no longer “public servants”. Due to an increasing conversely constituted a unique and valuable treasure of the attention to animal rights, after being privatized ENPA country. “He who mistreats animals”, put it bluntly by the found new energy, and intensified its activity of demanding Minister of Education Giuseppe Bottai, “cannot call himself more effective laws in terms of animal protection. Also, the Italian”. Hunting, on the other hand, was granted its status philosophy of animal welfare found a new alliance in the as “economic, sport, and military activity of the Nation”. growing environmental movement, in so far as associations of the likes of WWF (World Wildlife Fund) demanded The same bill which proclaimed the constitution of political action for protection of endangered species. ENFPA confirmed the status of Public Servants to its officers, who were to be authorized by the Ministry of As an explanation for the growing concern for Interior and were fully equipped with guns and rifles. These animals among the public, Maori suggests that some credit officers could supervise that animal experimentation in is to be given to the spread of naturalistic photography labs was performed according to the existing laws. Among and periodicals such as National Geographic (or Airone, in other accomplishments of the fascist era, they promoted Italy) and documentaries (most notably by Piero Angela), the adoption of a gun, fabricated by ENFPA, for more which made nature and non-human animals no longer humane technique of slaughter (which they hope to make a subject solely for experts and activists, but a topic mandatory). of discussion for laymen and households. Over the last decades, the Italian Parliament has approved several laws In the aftermath of World War II, after the Treasury of interest for those concerned about animal welfare, which gave its approval to the permanence of a national Maori describes at length in the last part of the book. The organization for animal welfare – the newly-renamed most important is the one promulgated in 2004, which ENPA continued to operate more or less according to the stipulated that several kinds of animal mistreatment (e.g. same guidelines hitherto followed. The following years saw torture, animal fights) were punishable as felonies. a growth in public awareness concerning issues of animal welfare, thanks to an increasing attention by the press, and Over the last decades, the Italian Parliament has of particular importance was the National TV Broadcast approved several laws of interest for those concerned about (Rai) dedicating some space to the topic. New organizations animal welfare, which Maori describes at length in the last were born between '50s and '60s, such as Lega Italiana part of the book. The most important is the one promulgated per la Protezione degli Animali (“Italian League for the in 2004, which stipulated that several kinds of animal Protection of Animals”) and the first vegetarian society mistreatment (e.g. torture, animal fights) were punishable (i.e. Società Vegetariana Italiana), all relying on ENPA’s as felonies. activity as their benchmark. In the author’s view, the bill – while more advanced than previous laws on the subject – can still be criticized The appearance of the first Italian Vegetarian under at least two respects. First, it fails to sanction any Society (1952) introduced into public debate the idea of involuntary inflictions of pain to animals, and second, it is “animal rights”, which gained increasing momentum in far from granting animals with a status as bearers of rights. the following decades. The law instituting the National At the same time, Maori accepts the point made by jurist Health Service (1978) assigned a major role to veterinarians Francesco Maria Agnoli, that “such recognition would have with regard to public hygiene as related to animals, implied a copernican revolution in Italian juridical system and zootechnical economic activity in particular. But [...] with relevant consequences that should be put to effect it was ENPA that provided funds and instruments to only on the basis of a wide social consensus, which at the help slaughterhouses comply with the law and thus time was lacking”. limit unnecessary infliction of pain to livestocks. Of course, the evaluation of what counted as necessary or Despite the potential bias of both the author and the unnecessary pain could differ, which caused a number of publisher towards the subject of the study, La protezione misunderstandings between ENPA and local municipalities animale in Italia fairly stands as a thorough and instructive (e.g. in the event of local fairs and festival, where animals reading, which compared to the existing literature is could be employed for entertaining purposes). probably unparalleled as to completion of information (not always depth of analysis). The last part of the book In 1979, under the initiative of the government noteworthily gathers a number of relevant documents, acts, chaired by Giulio Andreotti and with the approval of and speeches – discussed at length in the first part of the the President of the Republic Sandro Pertini, ENPA was book – which are related the development of animalist finally privatized, even though it had recently survived a movements and societies throughout history. bill that was meant to cut a number of “useless” public organizations. From then on, it ceased to be under the

Vasculab Journal of Theoretical and Applied Vascular Research (page 17) - JTAVR 2018;3(1):15-18 F Morganti - Animal welfare in Italy from unification to the XXI century: a recent book on the subject

References 1) Maori A. La protezione degli animali in Italia. Storia history of ENPA and of Zoophile and Animalist Societies from the Mid- dell’ENPA e dei movimenti zoofili e animalisti dalla metà Nineteenth Century to the Dawn of the New Millennium]. ENPA Ed., dell’Ottocento alle soglie del Duemila [Animal Welfare in Italy. The Roma 2016.

Vasculab Journal of Theoretical and Applied Vascular Research (page 18) - JTAVR 2018;3(1):15-18 A Maccaro - Beninese therapeutic pluralism. Historical roots and bioethical issues

HISTORY OF MEDICINE Beninese therapeutic pluralism. Historical roots and bioethical issues

A Maccaro1,2

1 PhD Philosophical Sciences, Humanities Department - University of Naples Federico II 2 Post- doc Social Sciences Department - University of Naples Federico II

submitted: Aug 4, 2018, accepted: Dec 3, 2018, EPub Ahead of Print: Dec 9, 2018, published: Jul 7, 2019 Conflict of interest: None

DOI: 10.24019/jtavr.53 - Corresponding author:Dr. Alessia Maccaro, [email protected]

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

Abstract Retracing the history of the spread of therapeutic tradition, conjecturing hypothetical forms of modern medicine in the former Kingdom of Dahomey, now peaceful and equal coexistence between traditional and the Republic of Bénin (sub-Saharan Western Africa), aims modern medicine. The angle of intercultural bioethics, far to provide a peculiar perspective of colonial domination from the long-standing multiculturalism, will allow us to that, as well known, has dramatically passed through the have a glimpse into the emerging ethical-political dilemmas form of controlling bodies that is not wrong to define as regarding this issue, as well as underline how the defense "biopolitical". The aim of the essay is attempting to show of therapeutic traditions, ascribable to the right of cultural how the gesture aimed at trampling the cultural identity identity, represents a form of guarantee of the human and of the people of Benin. Passing through the denial of of his rights. A true "white man's burden", to consider traditional therapeutic culture - which is disregarded, as responsibly in the perspective of an inclusive citizenship, to this day the primary medical reference remains that on which in today's times it’s urgent to reflect upon. of traditional medicine - re-proposes itself in forms that are apparently opposites in the attempt, only theoretical, Keywords traditional medicine, voodoo, Bénin, of contemporary politics to recover and defend the local bioethics

Introduction The progressive affirmation of Western medical "citizenship" - that means availability, in this case, of knowledge in Africa has been throughout history, as well modern medical and scientific knowledge, as well as of known, an indispensable instrument of colonial domination. rights and morals -, calls for the renunciation of cultural The deposition of traditional medical knowledge of African identity, seems to be experienced again in the contemporary populations, especially therapeutic one, has been for long phenomenon of emancipation. time a way of underestimating the cultural identity of a group and of imposing Western domination. In fact, the longed-for emancipation through rights as antidotes to violence is in some way a request to populations In fact, cultural difference has often been used to tend to a universal model and, therefore, to renounce to to legitimate the strongest power, under the name of their own culture, which is their identity, in order to become "mission", in order to impose its own identity, assumed citizens. ideologically as superior and, therefore, to discipline other people life without any guarantee of explicitly established Nevertheless, as we shall see, the universality of rights, in particular of human rights referred to, is not rules (biopolitics) (Rodotà, 20061). exclusive but inclusive, and asks people not to renounce to On closer inspection, however, the bad habit of their diversity, which is their specificity, but to preserve it the phenomenon of assimilation, which in return of in order to create horizons, where sharing is an option.

Vasculab Journal of Theoretical and Applied Vascular Research (page 19) - JTAVR 2018;3(1):19-24 A Maccaro - Beninese therapeutic pluralism. Historical roots and bioethical issues

1 Very well renowned is the closure manifested by knowledge and technical skills of the West which imposed the European powers in the colonial era towards the its supremacy (Bernardi, 1998, p. 217). colonized cultures and their traditions, above all therapeutic ones. This attitude was leaning on the Eurocentric Although government actions tended to agree to conviction of knowledge inconsistency of the indigenous the diffusion of modern medicine, in the various African populations who were simplistically dismissed as magical states there were discordant and unclear attitudes towards and superstitious practitioners. Such an attitude had the traditional therapeutic practices that went from the clean indirect aim of weakening the social, religious and even refusal of a legislative recognition to the informal approval political role of healers, disliked by the colonizers (Arnold, of traditional therapists, until the official recognition of 19882). Moreover the colonial empires engaged in an healers' role that, however, did not clearly regulate the areas ideological diffusion of the indigenous body as wild, of intervention permitted to them, as in Bénin's case. impure, sick, bearer of physical and moral contagion, which What is certain is that around the mid-70s there was had to be saved. Thus began the slow and inexorable a general change in the consideration of tribal therapeutic affirmation of rationalized, modern, western, scientific practices, certainly accelerated by the official recognition biomedicine, as of today mostly defined as "conventional" of traditional African medicine by the WHO, which in 1976 which, through the derision, reduction and denial of the defined it as: other people's culture, presented itself as a civilizing mission of the colonized population, the burden of white «Traditional medicine has a long history. It is the sum of 3 knowledge, skills, and practices based on theories, beliefs, and man (Kipling, 1899 ) and his essential moral obligation experiences indigenous to different cultures, as explicable or not, as (Marks, 19974). well as used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness»8. This is how the biopolitical control of the other began 5 Subsequently, in 1978, a declaration was issued by (Foucault, 2005 ), also passing through the missionary the WHO in Alma Ata in Kazakhstan recommending medicine with specific laws about it. A strict legislation member countries to promote and prefer the use of was imposed to all the colonies regarding healthcare policy. traditional medicine, especially in those areas where it This legislation was oriented to a massive construction of was recognized as Primary Health Care (PHC), through infrastructures (hospitals, dispensaries, pharmacies) which, the implementation of health programs that involved inevitably, led to a weakening of the role of traditional 9 therapists who were shortly forced to operate under illegal interacting with biomedicine . The main idea of this 6 proposal was that traditional medicine, with its widespread conditions (Comaroff, 1993 ). diffusion on the territory, could somehow meet the 10 In the aftermath of independence, in the second deficiencies of the official health system , above all the half of the twentieth century, the situation of the former almost impossible accessibility due both to costs, too colonies did not change much. The main efforts of the expensive even for an African employee, and to locations new African governments were aimed at strengthening of hospitals. They are in fact, concentrated only in urban the existing health infrastructures and, at most, improving areas, despite the majority of the African population is hygiene, by addressing these interventions to propaganda residing, and still resides, in rural areas. This recovery of campaigns purposes. Equally oriented to the affirmation of traditions was then endorsed by the same African politicians modern medicine were the interventions of international who persuaded themselves that supporting the endogenous organizations, mainly of the WHO and of the organizations resources with nationalistic ideological intentions could that were involved in aid projects and international represent a resource that could be spent on the level of cooperation: a new form of colonialism was arising, always political consensus, which, moreover, perfectly matches moved by the awareness of exclusive possession of the with the calculations of pharmaceutical companies.

2 When the WHO requested to enhance traditional placed on the enhancement of traditional, even medical, medicine, the Bénin, a Sub-Saharan West African country, culture (Dozon, 198711). responded positively right from the start [1]. After independence in 1960, it experienced a long twenty-year Here, therefore, the work of integration between Marxist-Leninist government led by General Kérekou in traditional and modern medicine was undertaken promptly, which, for ideological nature reasons, much emphasis was encouraging the inclusion of western health workers in rural Beninese villages. However, even though they had received

Vasculab Journal of Theoretical and Applied Vascular Research (page 20) - JTAVR 2018;3(1):19-24 A Maccaro - Beninese therapeutic pluralism. Historical roots and bioethical issues the task of making themselves available for the knowledge also respond to the desire of healers to improve their skills, of traditional practices with the aim of seeking forms of through the acquisition of new knowledge (Beinart-Brown- mediation and exchange with modern medical knowledge, Gilfoyle, 200914). in fact they limited themselves to transmitting the rudiments of basic health care to the healers and women in the role of The process of professionalization of indigenous midwives. This clearly suggests how the control matrix - ex. medicine, however, has involved a renegotiation of social of the births - of colonial mold was prevailing against the, roles, a redefinition of hierarchies, to which the leading although proclaimed, enhancement of traditional medicine. cadres of official health were not always ready (Last- Chavunduka, 198615). Moreover, integration was not limited to the action of doctors in tribal communities, but also included the Bénin once again exemplifies this collaboration introduction of traditional therapists, mostly voluntary, in between modern medicine and physiotherapeutic traditions. official health facilities where not only they could continue Even nowadays, in fact, more than 80% of the Beninese to learn notions of prevention and hygiene to be spread in population (WHO, 2002) uses traditional natural medicine the villages, but they would also have practiced their art to treat disease, since «in a context in which HIV, malaria, by offering care services. In fact, in some local hospitals, tuberculosis and many others diseases are the major as in the central hospital of the Borgou province, in 1984 concerns of public health and development, traditional volunteer healers were selected, by Beninese doctors, to medical knowledge and practices can be solutions to very put their skills at disposal of patients who could have complex problems related to taking care of the disease»16. been given traditional treatments under the supervision of hospital doctors. However, the experience turned out to be With this in mindset, even if traditional medicine is a total failure, since only two years later only one healer not yet fully integrated into the national health system, remained to offer his free consultations in the hospital, the Beninese Ministry of Health has implemented a hoping to be officially included in the medical group. Programme National de la Pharmacopée et de la Médicine Traditionnelles which, in addition to offering a regulatory The Beninese case immediately expresses one of the framework, proposes a code of ethics and conduct for the basic problems of integration projects between traditional practice of traditional natural medicine and makes possible and modern medicine, that is the one related to the nowadays «the production in commercial quantities of role assigned to healers, mostly compared to that of a standardized traditional medicines, in order to integrate nurse or paramedical staff, rather than that of a therapist traditional medicine into the national health system»17. to whom is recognized the possession of an effective and autonomous knowledge (Green, 198812). In fact, the However, as we read from the Code d’Éthique des conventional medical staff has shown certain diffidence Praticiens de la Médicine Traditionnelle, healers must towards traditional therapists, due to the difficulty of keep away from the practices of conventional medicine, they cannot use modern technical tools and cannot present accepting unorthodox medical practices (WHO, 198413). 18 Traditional medicine thus has come to fill the void of themselves as doctors or professors . So, expropriated by modern medicine, reducing itself to basic health care with a the spiritual character of their traditional role and unable prevalent purpose of popularizing the principles of hygiene to approach a modern role, they remain in an unclear and the importance of vaccines, which certainly has had limbo: obliged to reveal the composition of their effective its advantages, but fails to do justice to what it really medicines19, but not authorized to learn and use new represents. ones. In fact, on closer inspection, the idea of rationalizing traditional medicine through the study of medical plants With respect to this attitude, traditional healers used by healers, although it may seem a real form of opening in some circumstances were reluctant to accept the to cultural mentality and an appropriate form of integration, subordinate role that they wanted to impose them in fact it leans on a prejudicial attitude. The traditional and showed a disinterest or refusal regarding possible practices are in fact evaluated and judged on the basis of collaborations with modern medicine, in other cases instead Western scientific criteria, which, besides reiterating the they show a clear willingness to cooperate. After all, primacy of Western scientificity, conceals a continuing will the institutional recognition and inclusion in the official to control the activities of traditional therapists. medical structure could not only lead to an increase in social prestige, and sometimes economic advantages, but could

3 It is indeed evident that the clear division between traditional medicine that is more tending to a spiritual/ traditional medicine of a more herbalist nature and the supernatural sphere is mostly artificial and is a further

Vasculab Journal of Theoretical and Applied Vascular Research (page 21) - JTAVR 2018;3(1):19-24 A Maccaro - Beninese therapeutic pluralism. Historical roots and bioethical issues forced attempt to understand traditional medicine according medicine, not only because this is an act of violence against to criteria that are familiar to the modern mentality. Healers, the cultural identities that derive from it, but also because in fact, move between the two areas, resorting, according this would mean to deny the value not only cultural, but also to the case, to herbalist or spiritual practices, but also the curative of traditional practices. former ones share the same symbolic set of spiritual ones and it is therefore difficult to isolate the aspects that can Once again, the dilemma regarding the modalities be scientifically analyzed without changing the horizon of of integration between traditional and modern medicine, meaning in which they move. becomes more and more decisive in the measure in which it seems impossible to speak of integration without distorting Traditional medicine, as it is known, responds to the the first system of care or presenting the second as an cultural systems from which it arises and does not limit the imposition. The real problem is that not only it is difficult disease to the simple biological event alone, but intends it to talk about integration, but we should probably also ask through a holistic, global approach and, therefore, is able to ourselves whether it is indeed desirable an integration give an overall response to an uneasiness that is at the same considering that inevitably leads to the loss of identity of time biological, existential, social and cultural (Eisenberg, tradition. 20 1977, p.11 ). In fact, all the national and international maps reaffirm the indispensability of respect for traditions, which Therefore up to now, rather than the real integration not only pertains to the sphere of freedom - understood as between the two models of traditional and modern freedom of conscience and worship - but is a fundamental medicine, there has been an attempt by official medical- and inalienable right of every individual or group that health institutions to bend the ideological models and is a duty of the states to guarantee. As stated in art. 17 traditional therapeutic practices to the scientific paradigms, paragraphs 3 the African Charter of Human and People's denying the magical-religious configurations of symbolic Rights composed of the Organization de l’Unité Africaine systems to which those practices are closely linked. And (OAU) in 1981 and ratified by Bénin on January 20, 1986: this, evidently, implements a real reduction rather than an «The promotion and protection of morals of traditional enhancement of traditional knowledge. values community shall be the duty of the State»21. This attitude is certainly a legacy of imperialism It is therefore evident that it is impossible for the which, by operating indirect control over political elites, is traditions to be swallowed up in the process - even if the backbone of the forms of neocolonialism that belong necessary - for the diffusion of modern medicine. However, to our era [2]. In fact, the process of modernization, since integration does not always mean restitution of by advancing inexorably, has expanded in a way that dignity and enhancement of indigenous traditions, but, marginalize the traditional system. Such system, in order to paradoxically it can contribute to their distortion and exist, must deny itself in its overall essence and show only their disappearance, we must re-discuss the concept of that quantum that is able to the "normalization", which can integration since, full as it is of stereotypes and prejudices, only lead to the progressive disappearance of tradition. is operationally impractical (Benoist, 198922; Dozon- In this way, different and extremely delicate Sindzingre, 198623). Probably more than integration we questions arise: on one hand it is clear that modern should be content with cooperation between two semantic medicine, being the one whose efficacy is most proven, universes that are different, but complementary, which must should spread without limits in order to guarantee everyone begin by providing a genuine recognition of traditional the right to adequate medical treatment and the right to medicine as a whole, not claiming to separate only few healthcare; on the other hand, in order for these rights to technical aspects denying the theoretical foundations of be guaranteed, each individual should be put in the position the entire cultural system (Habermas - Taylor, 199824). to benefit from it, which means, therefore, reviewing the Denying the recognition of cultural traditions, denying their problems of access to health care and free treatments of dignity, is, in fact, a way of killing the other, his identity, the health system, which are still dramatically unsolved in that is no longer existent after the tragedies that history has Africa. However, the fact that the importance of the global witnessed which degraded the real meaning of human being diffusion of biomedicine is not questionable does not imply and that memory would better hold back more firmly. that such modernization should stifle or distort traditional

4 Bioethical reflection then becomes necessary to the also to the right to guarantee recognition and respect for extent that it appeals not only to morals, to medicine but

Vasculab Journal of Theoretical and Applied Vascular Research (page 22) - JTAVR 2018;3(1):19-24 A Maccaro - Beninese therapeutic pluralism. Historical roots and bioethical issues traditions, which is a fundamental human right that has only a certain sense increases the self-determination of the been partially guaranteed until now. individual with respect to the choices of care, since the patients can decide to refer now to one now the other In this regard the Universal Declaration of Bioethics health reference always with the guarantee of the state on and Human Rights, promoted by UNESCO in 2005, in the validity - even before accessibility (Anyinam, 198726), art. 12 reads: «the importance of cultural diversity and which is a different problem from the one examined - of pluralism should be given due regard. However, such both. considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon Therefore, regardless of the proposal of decentralized the principles set out in this Declaration, nor to limit their cooperation between traditional and modern medicine, what scope»25. would seem to be no longer postponed in our society, that professes itself as pluralist, is a more convinced definition Therefore it seems to be possible to say that a of ethical and political strategies that are genuinely capable genuine cooperation between complementary care systems of guaranteeing respect for therapeutic traditions and, at is possible only after a genuine recognition of traditions, the same time, respect for the rights of care which also which must first be legislative. As mentioned, in fact, the former ones consist of. However, as we have seen, the traditional medicine is practiced, tolerated and even protection of the traditional philosophical constructs of each partially regulated by ministerial documents , but it is not population goes beyond the sanitary discourse and refers to legislated. The health system, for its part, must show itself the principles of identity, freedom and dignity, belonging capable of recognizing in its complex the plural but not to the list of fundamental human rights that cannot be discordant souls that inhabit it: this will mean no longer circumvented by the overwhelming push of the modern, imposing, but arranging the conditions to carry out a especially in those countries where the latter is not yet fully reform that invests the entire health structure, that should guaranteed. be oriented towards a decentralization of its own point of view as well as of the cure strategies to pursue. Therefore if «under the title of third generation of human rights sometimes is included the right to cultural In this way modern medicine will be able to get closer identity with its linked claims» (Kaufmann, 2009, p. 5627), to culture and population, but on the other hand we must the latter one, being part of the framework of human continue to bring traditional medicine closer to the rigor of rights, is recognized as being inalienable and, therefore, science, taking into consideration not only the quantitative not required to mediate - unless it endangers human rights aspects, but also the qualitative ones of the conceptual themselves - or compromise with modernity. However, and philosophical system at the base of this therapeutic recognizing this is only the first step to rethink the question approach. of the relationship among human rights and, above all, the duty of states to guarantee them in respect of social From a practical point of view, decentralization will justice and human dignity, especially in relation to the also imply that the two offers of care must be more present so-called Third World countries and, in particular, to the both in urban and rural areas: this means not only yearning health problem, becomes less and less possible to postpone for greater coverage of the national health system, but also (Nussbaum - Sen, 199328). preserving the presence of therapists in the area.

In this way, the real complementarities between the two therapeutic options can be manifested, which in

Endnotes [1] It’s been 15 years since Africa has been celebrating 2017: https://afro.who.int/fr/news/le-benin-commemore-la-15ieme- the day of traditional medicine, as proposed by the "Ouagadougou journee-africaine-de-medecine-traditionnelle (nov. 2018). Resolution" on the Traditional Medicine (31 Aug 2000). Benin has been celebrating it under the auspices of the Ministère de la Santé, [2] The studies of P. Hountondji on what he calls every 17th of November. During last meeting Prof. Roch Hougnihin, "mondialisation des savoirs" are particularly important in this Coordinator of National Program of Pharmacopeia and Traditional regard, mainly because it creates a series of interpretative and Medicine underlined the importance of this day which is, according epistemological difficulties especially, and above all, towards the to him, a unique opportunity for taking stock of the situation related theme of decolonization of African knowledge. As a matter of facts, to traditional medicine in Benin, especially in relation to what the author shows how some African intellectuals, first supporters of concerns the knowledge transmitted by the ancestors, as well as the an anticolonial policy, now justify the choices of governments and invaluable natural resources of the country. WHO Benin. Le Bénin a contemporary policies which, in fact, favor the diffusion of a dimension commémoré la 15ieme Journée Africaine de Médecine Traditionnelle, that is only partial to tradition.

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2) Arnold D. Imperial Medicine and Indigenous societies. 16) Ministère de la Sante, Direction Nationale de la Manchester: Manchester University Press; 1988. Sante Publique, République du Bénin, Programme national de la Pharmacopée et de la médicine traditionnelles (PNPMT), Manuel 3) Kipling R. The White Man’s Burden. McClure’s Magazine. d’initiation des professionnels de la santé aux systèmes d’éducation 1899 Feb 12. et de transmission du savoir en Médicine Traditionnelle au Bénin, Cotonou: Janvier 2011:8. 4) Marks S. What is colonial about colonial medicine? And what has happened to imperialism and health? Social History of Medicine. 17) Protocole de prise en charge du paludisme basé sur les 1997 Aug 1; 10(2):205-219. pratiques traditionnelles efficaces au Bénin, Cotonou: Septembre 2009. 18) Code d’éthique des praticiens de la médicine traditionnelle: 5) Foucault M. Nascita della biopolitica, (Collège de France Loi N° 2010/40 du 8 Decembre 2010, art. 31. 1978-1979). Milano: Feltrinelli; 2005. 19) Mahomoodally MF. Traditional Medicines in Africa: 6) Comaroff Je. The diseased heart of Africa. Medicine, An Appraisal of Ten Potent African Medicinal Plants. Evidence- colonialism and the black body. In: Lindenbaum S, Lock M, editors. Based Complementary and Alternative Medicine [Internet]. Knowledge, power and practice. The anthropology of everyday life. Hindawi Limited; 2013;2013:1–14. Available from: http:// Berkeley: University of California Press; 1993. p. 305-329. dx.doi.org/10.1155/2013/617459

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9) International Conference on Primary Health Care (1978 : 22) Benoist J. Médecine traditionnelle et médecine moderne en Alma-Ata, USSR), World Health Organization & UNICEF. (1978). République Populaire du Bénin. Écologie humaine, bulletin d’écologie Primary health care : report of the International Conference on humaine. 1989;7(1):84-9. Primary Health Care, Alma-Ata, USSR, 6-12 September 1978 / jointly 23) Dozon J-P, Sindzingre P. Pluralisme thérapeutique en sponsored by the World Health Organization and the United Nations médecine traditionnelle en Afrique contemporaine. Prévenir. 1986; Children's Fund. Geneva : World Health Organization. Available at the (12):43-52. address http://www.who.int/iris/handle/10665/39228 at the date of Dec 8, 2018. 24) Habermas J, Taylor C. Multiculturalismo. Lotte per il riconoscimento. Milano: Feltrinelli; 1998. 10) Kofi-Tsekpo M. Institutionalization of African traditional medicine in health care system in Africa. Afr J Health Sci. 25) UNESCO. Universal Declaration of Bioethics and Human 2004;11(1-2):I-II. Rights. 2005. Available from http://www.unesco.org/new/en/social- and-human-sciences/themes/bioethics/bioethics-and-human-rights/ at 11) Dozon J-P. Ce que valoriser la médicine traditionnelle veut the date of Dec 4, 2018. dire. Politique Africaine. 1987;28:9-20. 26) Anyinam C. Availability, accessibility, accettability and 12) Green EC. Can collaborate proper between biomedical and adaptability: four attributes of african ethnomedicine. Social Science African indigenous health practitioners succed. Social Science and and Medicine. 1987;25(7):803-11. Medicine. 1988;27(11):1125-30. 27) Kaufmann M. Diritti umani. Napoli: Guida; 2009.

13) WHO. Traditional medicine and health care coverage. A 28) Nussbaum M, Sen A, editors. The Quality of Life: a Study reader for health administrators and practitioners. Geneva: WHO; 1984. Prepared for the World Institute for Development Economics Research of the United Nations University. Oxford: Clarendon Press; 1993. 14) Beinart W, Brown K and Gilfoyle D. Experts and Expertise in Colonial Africa Reconsidered: Science and the Interpenetration of Knowledge. African Affairs. 2009 Jul;108(432):413-33.

Vasculab Journal of Theoretical and Applied Vascular Research (page 24) - JTAVR 2018;3(1):19-24 E Grenier, D Rastel, C Chaigneau - Evaluation of an accelerometer-based device to monitor compression compliance

COMPRESSION THERAPY ORIGINAL PAPER Evaluation of an accelerometer-based device to monitor compliance on patients wearing medical compression stockings

E Grenier1, D Rastel2, C Chaigneau1

1 SIGVARIS, Z.I. Sud d’Andrézieux, rue Barthélémy Thimonnier, BP 60223, 42170 Saint-Just Saint-Rambert, France 2 Vascular physician, responsible for medical device vigilance, SELURL Philangio, 30 place Louis Jouvet, 38100 Grenoble, France

submitted: Jul 16, 2018, accepted: Nov 3, 2018, EPub Ahead of Print: Dec 9, 2018, published: Jul 7, 2019 Conflict of interest: D. Rastel is a private-sector vascular physician and non-exclusive consultant for medical textile manufacturer, SIGVARIS. E. Grenier and C. Chaigneau are employed by SIGVARIS in the respective functions of Research Associate and Head of Advanced Studies.

DOI: 10.24019/jtavr.51 - Corresponding author:Ing. Etienne Grenier, [email protected]

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

Abstract During the course of the study, the ten instrumented I- INTRODUCTION stockings captured 34 days that were representative of wear Medical compression, for the most part employing and 48 non-wear days. The absolute mean errors (and the textile methodology, constitutes the principal conservative standard deviation associated) calculated on the basis of the treatment prescribed in the case of venous disorders. wear times reported by the patient and wear-times measured However, its role is subject to debate in the scientific by the devices range between 5 (5) minutes and 83 (26) community. Treatment is only effective if the orthosis is minutes, which corresponds to relative errors of between 1 worn on a daily basis and clinical studies suffer from (0.9)% and 19 (7.1)%. For 27 days, the absolute difference significant bias in relation to how patient compliance is between the subjective and the objective wear-times is less measured. than 60 minutes. The results gathered by the sensors during II- AIMS non-wear days are 0 minute for 4 patients, representing An electronic measurement device has been developed 41 days of experimentation (85%). On the other hand, to measure patient compliance; it is based on movement one patient's devices incorrectly wrongly recorded average detection by an accelerometer sensor. The aim of the present wear periods of 55 (55) minutes and 23 (16) minutes. study is to compare objective data captured by the electronic No incidents or undesirable effects were reported by the device with wear times as reported by studied patients. patients. III- METHODS V- CONCLUSION The present study was conducted on 5 patients who The specially-developed electronic device is based on the were being treated for uncomplicated superficial venous principle of detection of phases of wear as registered by insufficiency with a medical prescription for class 2 an accelerometer sensor. Integration of the system in an compression hose to be worn daily. Two pairs of currently- elastic compression stocking enables acquisition, analysis marketed stockings were provided to the patients. One and interpretation of an acceleration signal thus providing stocking of each pair was fitted with the electronic objective monitoring of patient compliance as a function of monitoring device. The patients were requested to wear the periods of wear and non-wear. their compression hose as normal and to note the dates and times of any incidents and any undesirable effects. Keywords Medical compression stockings, IV- RESULTS compliance, accelerometer-based device

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1 Introduction the compression stocking and identifies the periods when the stocking is worn and when it is not worn. Compression therapy remains, at the present time, Three parameters that are configurable when the the cornerstone of lower limb venous disease treatment1,2. electronic chips are initiated are designed to optimise It decreases venous volume at rest, decreases ambulatory detection of wear and non-wear periods. The cycle (or venous hypertension, increases muscle pump function time interval) between two events can be set in a range 3,4 and acts positively at the microcirculatory skin level . going from 1 to 120 minute with a step of 1 minute. Compression therapy is mainly textile in the form of The movement detection threshold value was set at 0.3G bandages or stockings and its clinical results depends on and the accelerometer signal averaging time was 800 different parameters such as the level of pressure, the ms. These values were established by analysis of the cumulative pressure at rest and in movement, whether the data from experiments in real conditions of use and by textile is correctly applied on the leg or not5. So, among integrating situations representative of product use in daily them, the wearing time is one of the greatest importance. life (standing, sitting and lying down). The purpose of A major bias in clinical studies on compression therapy is the parameters is to optimise detection sensitivity and the the compliance6. If compliance can be easily checked by accuracy of data gathered relating to wear phases even in nurses when bandages are used it is scarcely measured with lengthy quasi-static situations and to minimise instances of stockings. When measured, it is through questionnaires that false detection when the stocking is not being worn. are firstly not validated in term of internal and external Wear data and the associated time-stamp are recorded coherences and secondly self-administered by patients, at regular intervals in the embedded memory. Recording consequently leading to biases7. frequency can be set when the chip is initiated. Patients at rest do not represent to a great extent a The 256-Kbits Electrically Erasable Programmable compliance problem since in most cases they are inpatients Read-Only Memory (EEPROM) can store data of wearing and hospital staffs regularly check the compression device. during 340 days with sampling every 15 minutes. The To solve the problem on active patients raised the idea to absolute maximum value of acceleration occurred during insert a sensor in the stockings. A first one « Thermotrack® each period is stored on the first 7 bits of one byte. The acceleration value by triggering the motion detection is » has been used in a restricted number of patients7,8 used to determine the wearing state (Yes or No). The Unfortunately, this electronic device based on advantage of this technology is that all recorded data is temperature increase detection, cannot be used in certain saved even in the absence of power. Consequently, there climate. As a consequence, an electronic device based on is no loss of data if the battery becomes discharged before motion detection with an accelerometer was developed. The the compliance data are extracted. Selection criteria for objective of this work is to compare the objective results of the electronic components and CR1616 microcontroller- the device to the wearing time reported by patients and then embedded software were extremely stringent in order to adapt its use to the compliance measurement of medical meet energy-saving requirements and to ensure maximum compression stockings (MCS) in active patients. device autonomy. 2 Materials and methods The electronic card lengths are 26 x 16 x 3 mm. To ensure a perfect seal, the electronic card is included into a silicone casing which sizes lengths are 30 x 20 x 8 mm 2.1 Electronic monitoring device (Figure 1).

2.1.1 Technical characteristics and operating principle The electronic monitoring device is an electronic chip enabling assessment of the period of wear of a compression stocking. The system was developed by 3DOuest and Feichter Electronics (Lannion, France), specialists in electronic hardware and software design, on the basis of a SIGVARIS functional specification. It comprises a CR1616 button cell (Lithium 3V, 55mAh), with an autonomy of around four months in active mode and three key electronic components: - a three-dimensional Figure 1 - From left to right: electronic monitoring chip, accelerometer, a microcontroller and a memory. The silicone base, device set inside the base, device sealed by accelerometer detects movement of the device embedded in potting silicone.

Vasculab Journal of Theoretical and Applied Vascular Research (page 26) - JTAVR 2018;3(1):25-32 E Grenier, D Rastel, C Chaigneau - Evaluation of an accelerometer-based device to monitor compression compliance

Timestamp Event detected

Tue Aug 10 19:12:34 YES Tue Aug 10 19:27:34 YES Tue Aug 10 19:42:34 YES Tue Aug 10 19:57:34 YES Tue Aug 10 20:12:34 YES Tue Aug 10 20:27:34 YES Tue Aug 10 20:42:34 NO Tue Aug 10 20:57:34 NO Tue Aug 10 21:12:34 NO

Table I - Example of raw data extraction for a period of two hours sampled every 15 minutes.

Date Wear time Wear time (s)

Mon 5th Sep 12h30m 45000 Tue 6th Sep 7h15m 26100 Wed 7th Sep 0h0m 0 Thu 8th Sep 0h0m 0 Fri 9th Sep 11h15m 40500 Sat 10th Sep 0h0m 0 th Sun 11 Sep 0h0m 0 Figure 2 - Functional diagram for the automatic data Mon 12th Sep 5h0m 18000 processing algorithm Tue 13th Sep 5h30m 19800 2.1.3 Data processing, analysis and summary Wed 14th Sep 6h0m 21600 To facilitate raw data analysis, a data processing routine was developed in a programming environment (MATLAB®), comprising three functions. The main Table II - Example of a summary table generated by the function handles sequential command execution and automatic software routine used to analyse data recorded utilises the two other functions that are dedicated to filtering by electronic monitoring devices. and data time conversion. Figure 2 illustrates the routine's algorithmic process. 2.1.2 Raw data extraction "False negative" occurs when the device has not The data recorded in the monitoring device chip detected a real wear event. Conversely, a "false positive" memory is extracted by means of dedicated software and occurs when the device has wrongly detected a wear event. a communication interface linked to a computer via an Thus, by filtering the events, it is possible to eliminate Universal Serial Bus (USB) connection. Communication cases of incorrect detection of wear or non-wear events. between the electronic chip and the communication The digital filter was developed to take account of two interface is via the electrical contact points. Raw data are consecutive periods functioning as a sliding window over displayed and can be saved to a spreadsheet file (.csv) in the the event vector. It acts as an averaging process (low-pass software interface (Table I) for general analysis of patient filter) for short and fast variations in the wear signal. compliance. This file contains all wear information (Yes / Based on the filtered signals, the programme No) in the "Event detected» column, along with the relevant generates and records two files: timestamp.

Vasculab Journal of Theoretical and Applied Vascular Research (page 27) - JTAVR 2018;3(1):25-32 E Grenier, D Rastel, C Chaigneau - Evaluation of an accelerometer-based device to monitor compression compliance

Figure 3 - Example of a graphical illustration of data monitored (YES/NO) obtained by the data extraction routine. Display of the effect of filtering in the elimination of false positives (purple circle) and false negatives (green circle). The red vertical lines represent the days of experimentation.

Figure 4 - Representation of wear times reported by the patients in comparison with wear times measured by the monitoring devices during the compression stocking wear days (n=34)

1. Daily wear time summary file (Table II). This file comprises Both Table II and Figure 3 document display the three columns - event dates associated with wear times expressed in findings of the same experiment. hours/minutes (unit commonly used) and seconds

2. Graphical representation of event vectors as a function of 2.1.4 Device integration in the medical various types of filtering - raw signal and filtered signal of the MCS’s compression stocking wearing (Figure 3). This overview and visual representation are useful to quickly verify the raw signal recorded by the electronic device and The electronic chip is protected against water ingress the result of the filtering process. Also, it would be a quick and easy way to observe compliance data by the patient or the health professional. by silicone encapsulation (moulding and potting) which is resistant to hand- and machine-washing (30°C wash and 800 rpm spin cycle).

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Testing was conducted to assess resistance to character to distinguish the stocking pairs allocated to the machine-washing. After thirty (or so) washes in a short patient. cycle of 30 minutes at 30°C, the electronic chips had not suffered any damage. The silicone envelopes were The results are presented separately for the days not damaged or torn and the electronic chips remained where the patients stated that they had worn their stocking operational. This solution of silicone encapsulation can and the days when they reported that they had not worn therefore be confirmed to guarantee water-tightness and them. We consider that the reference wear times are those device protection. reported by the patients.

The device is inserted into the reverse side of the Over the course of the study, the ten instrumented compression stocking and sewn in. stockings enabled us to capture 34 representative wear days and 48 days of non-wear. Figure 4 shows the wear times 2.2 Protocol reported compared to the times measured by the monitoring devices and the theoretical straight line (dotted black line) Five patients receiving medical treatment for shows a perfect relation between the two variables. It can uncomplicated superficial venous insufficiency who had be noted that in 30 out of 34 cases, the measured wear times been prescribed class 2 compression stockings for daily are greater than the reported wear times. wear (with a pressure of 15-20 mmHg exerted on the ankle, 9 Based on all the wear days, the averages and standard AFNOR standard G30 102 B), commercially-available deviations were calculated for both the reported and the and that was fitted with a sensor. MCS used in this study measured wear times. This data is used to determine the are socks composed of 50 % Aquarius Polyamide / 27% stocking wear time per day and after-the-event assessment Elastane / 23% Polyamide and 36 % Polyamide / 16 % of the patients' level of compliance (number of days per Elastane / 48 % Bamboo Viscose labelled URBAN and month and number of hours per day). BAMBOU, respectively. For example, if a wearing time of 10 hours had been The patients gave their consent to participate in the recommended, it was observed that patient 1 was more study. As the device under test was to be ultimately used compliant in terms of the average daily wear duration (723 as part of clinical trials, this patient study was conducted (64) minutes/day for one pair and 710 (145) minutes/day for as part of ANSM's (Agence Nationale de Sécurité Sanitaire the other pair) compared to patient 5 (486 (149) minutes/ du Médicament - National Agency for Safety of Health day and 405 (105) minutes /day). This observation is also Products) medical device vigilance programme under the confirmed by the wear times measured by the monitoring responsibility of the second author who is specifically devices: 743 (71) and 732 (152) minutes/day for patient 1 responsible for elastic compression hose vigilance. Prior to and 552 (122) and 443 (83) minutes/day for patient 5. testing, it was checked that the devices, once inserted into the stocking, had not altered the compression characteristics For each wear day, the absolute and relative of the compression hose. differences were also calculated on the basis of the wear times reported by the patients and the durations measured One stocking of the pair was fitted with the electronic by the devices. The absolute mean errors between these monitoring device. Two pairs of "recording" stockings were two wear time types range between 5 (5) minutes and 83 distributed to the volunteers. The tests took place over (26) minutes, which corresponds to errors varying from 1 an approximate period of one week. The patients were (0.9)% and 19 (7.1)% compared to the reported reference requested to wear their compression stocking as normal time. Table III summarises all reported and measured data and to note date and time information relating to various and provides the results of associated comparisons. Both wear events - donning and doffing, wash type (hand-wash columns contained under each patient present the results or machine-wash), stocking handling (stretching, storage, from a device integrated in MCS. For example, D1a means etc.), and any undesirable effects. Device integrated in the first pair of the patient 1 and D1b in the other pair. The monitoring devices were configured for a 10- minute sampling and recording interval for patients 1, 2 and For the entire period of wear, 34 days, eighteen 3 and 15 minutes for patients 4 and 5. show an absolute difference between the subjective and objective wear time of less than 30 minutes. This difference 3 Results is between 30 and 60 minutes on 9 days and between 1 hour and 2 hours 45 minutes on 7 days (Figure 5). Stocking wear time data were extracted from the monitoring devices, processed and analysed in accordance Moreover, it is interesting to analyse the data with the methods outlined above. Each monitoring device measured by the monitoring devices during the periods was identified by the patient number and an alphabetical when the stockings were not worn. The phenomenon known

Vasculab Journal of Theoretical and Applied Vascular Research (page 29) - JTAVR 2018;3(1):25-32 E Grenier, D Rastel, C Chaigneau - Evaluation of an accelerometer-based device to monitor compression compliance as "false negative" indicates incorrectly reports wear data non-wear phases as the wear durations are equal to 0 and consequently leads to overestimation of the total wear minutes for 4 patients out of 5, thus representing 41 days duration. of experimentation (85%). By contrast for the patient 1, monitoring devices recorded an average wear period of 55 In our experiment, according to the patients, the total (55) minutes for pair A and 23 (16) minutes for pair B, when number of non-wear days was 48. The results obtained in fact medical compression stockings were not worn (Table from the monitoring devices are consistent with these IV).

Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 D1a D1b D2a D2b D3a D3b D4a D4b D5a D5b Experimental day day 3 4 3 2 4 3 6 2 5 2 considered Wear Time Mean minute 723 710 668 655 634 450 405 720 486 405 Reported (std) (64) (145) (139) (105) (127) (150) (150) (150) (149) (105) Wear Time Mean minute 743 732 683 650 628 483 475 803 552 443 Measured (std) (71) (152) (156) (90) (114) (176) (158) (128) (122) (83) Absolute Mean minute 20 22 22 5 46 47 75 83 66 53 difference (std) (13) (8) (10) (5) (29) (26) (30) (26) (40) (8) Max minute 30 30 30 10 105 85 120 105 165 60 Min minute 0 10 0 0 10 20 30 60 15 45 Relative Mean % 4 3 3 1 7 11 19 13 18 14 difference (std) (0.4) (0.5) (0.6) (0.9) (3.8) (5.7) (7.1) (5.8) (15.3) (5.6)

Table III - Summary of stocking wear times obtained from patient reports and from data for wear days as measured by the monitoring device. D1a means "device integrated in the first pair of the patient 1 and D1b in the other pair" and so on for the other patients.

Figure 5 - Breakdown of absolute wear time differences between patient-reported data and data captured by the monitoring devices

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Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 D1a D1b D2a D2b D3a D3b D4a D4b D5a D5b Experimental day day 4 3 4 5 3 4 4 8 5 8 considered Absolute Mean minute 55 23 0 0 0 0 0 0 0 0 difference (std) (55) (16) (0) (0) (0) (0) (0) (0) (0) (0) Max minute 130 40 0 0 0 0 0 0 0 0 Min minute 0 0 0 0 0 0 0 0 0 0

Table IV - Summary of stocking wear times obtained from patient reports and from data for non-wear days as measured by the monitoring device. D1a means "device integrated in the first pair of the patient 1 and D1b in the other pair" and so on for the other patients.

4 Discussion The reliability of the results captured by the monitoring devices was assessed by comparison with the The principal outcome of the study is confirmation of wear times reported by the patients. In spite of strict the effectiveness of an electronic device to measure patient experimental conditions, it is possible that the reported compliance with prescribed wear of medical compression compression stocking donning and doffing times are, to a stockings. During the study, measurements were recorded certain extent, approximate, depending on the time lapse by an electronic chip using an accelerometer to detect between the event and the moment the event is noted down. movement of the device and also records the data at regular For example, it might be difficult to remember the exact intervals. time the compression stockings are donned if the wear times The central aim of the system is to help in a greater are noted down at the end of the day. The accuracy of this extent a health practitioner to obtain data relating to the data may be questionable, which might, to a certain extent, overall use of the prescribed compression hose. Despite explain the differences between the reported and measured the uncertainty of daily wear times stemming from the periods of wear. This therefore introduces another period monitoring devices, thanks to the sensor it is possible to relating compression stocking wear time that is defined by assess a patient's pattern of compliance, namely by taking the true wear duration. into consideration the days when the compression stockings are not worn. Thus, what is the impact on the health During the experiment, the interval between each data practitioner's conclusions based on daily wear data that capture of compression stocking wear was set at between 10 might include an error of one or two hours? Is currently and 15 minutes. This temporal resolution could possibly be our monitoring device sufficiently accurate to meet the reduced to 5 minutes in order to minimise the error induced requirements of compliance objectification or the level of by false positives. The wear time results are very frequently compliance observed by the ultimate data user? overestimated by the monitoring devices in relation to the times reported by the patients. The overestimation is Under certain conditions of daily use, the electronic less than one hour for over three quarters of the wear chips may incorrectly detect movement (and be confused days and the maximum overestimation was 2 hours 45 with wear periods). These "false positives" may be due to minutes. These variations can be explained by independent different phases of use of the compression hose, such as, or successive washing, drying and storage phases that are for example, washing, drying in the open air (wind effect), wrongly considered to be wear phases, due to detection of spare pair of stockings being carried in a handbag, stockings stocking movement. being displaced in a wardrobe, etc. Incorrect detections may then induce an error in the daily wear time results, the From a material point of view, the devices are duration of which may vary as a function of the conditions encapsulated in a silicone case and it is not possible of use. Conversely, when the compression stockings are to check the functional status during the trial without effectively being worn, it is possible that the device does not destroying the device. To access recorded data or data detect any movement during periods when the lower limbs in the course of recording, it is necessary to break into are immobile (when taking a siesta, or sitting down reading the compression hose and the case in order to retrieve or watching TV). However, we have no means of evaluating the data via the communication interface between the said errors (over estimation or underestimation) measured chip and the computer. It would be preferable to be by the monitoring devices in relation to usage criteria and able to interrogate the monitoring device via a wireless to distinguish them between true periods of use. connection (Bluetooth, WiFi, ZigBee, RFID, NFC, etc.).

Vasculab Journal of Theoretical and Applied Vascular Research (page 31) - JTAVR 2018;3(1):25-32 E Grenier, D Rastel, C Chaigneau - Evaluation of an accelerometer-based device to monitor compression compliance

This functionality would not only enable us to verify the associated with an algorithm to process, analyse and operational status of the electronic system but also to summarise patient compliance reported on a daily basis. By extract and display at regular intervals the data saved in embedding this system in an elastic compression stocking, the memory. Furthermore, the autonomy is not sufficient we have demonstrated that it is possible to objectivise the to enable evaluation of compliance over a 6-month period wear and non-wear phases by acquisition, analysis and (compression hose legal guarantee period); we will have interpretation of an accelerometer sensor signal. to find solutions to overcome this difficulty. The device's compact design constitutes a major advantage, as there is The trial consisted of a study conducted by 5 patients no discomfort when the compression stockings are being wearing medically-prescribed compression stockings in worn. In a large-scale mass-production approach, power order to evaluate the reliability of the results delivered by autonomy could be increased and the dimensions could the monitoring devices. We captured 34 days representative be very significantly reduced by the use of specific, more of compression stocking wear days and 48 non-wear days. powerful electronic components. In the course of the experiment, we have demonstrated that data relating to patient compliance with a medical The device developed has been validated, contrary prescription for compression stockings can be acquired and to other devices already in use. However, in the future, recorded over a period of several months without changing advancements in wear detection systems are likely to focus the patients' normal lifestyle. The difference between the on physiological parameter acquisition (dermal impedance, wear times reported by the patients and the durations capacitive proximity detection, etc.) that is modified solely measured by the monitoring devices is less than 60 minutes by textile/lower limb interaction. for 79% of the wear days. The results of the monitoring devices also demonstrate the accuracy of the data in 85% 5 Conclusion of the days when the elastic compression stockings were not worn. These errors could result in uncertainty as to the We have developed an electronic device based the actual daily wear durations but do not, however, have a detection of wear times by means of an accelerometer major impact on objectivation of overall patient monitoring.

References 1) Wittens C, Davies AH, Baekgaard R, Brohlom A, Cavezzi A, 6) Ziaja D, Koce#ak P, Chudek J, Ziaja K. Compliance with Chastanet S, et al. Management of Chronic Venous Disease. Clinical compression stockings in patients with chronic venous disorders. Practise Guidelines of the European Society for Vascular Society Phlebology. 2011; 26(8): 353-60 (ESVS). Eur J Vasc Endovasc Surg 2015; 49: 678-737. 7) Allaert FA, Rastel D, Graissaguel A, Sion D, Hamel- 2) Rabe E, Partsch H, Hafner J, et al. Indications for Desnos C. Design and evaluation of the psychometric properties medical compression stockings in venous and lymphatic disorders: of a self-questionnaire on patient adherence to wearing elastic An evidence-based consensus statement. Phlebology 2017; doi: compression stockings. Phlebology. 2018 Jan 1:268355518762824. 10.1177/0268355516689631 doi: 10.1177/0268355518762824. Epub ahead of print]

3) Bergan JJ, Geert W, Schmid-Schönbein PD, et al. Chronic 8) Uhl JF, Benigni JP, Chahim M, Fréderic D. Prospective venous insufficiency. N Engl J Med 2006; 355: 488-98. randomized controlled study of patient compliance in using a compression stocking: Importance of recommendations of the 4) Partsch H. Mechanism and effects of compression therapy. practitioner as a factor for better compliance. Phlebology. 2018; In: The Book. London: Elsevier; 2007, 103-109. 33:36-43. 9) AFNOR, Association Française de NORmalisation. https:// 5) Partsch H. Compression therapy: clinical and experimental www.afnor.org/en/ evidence. Ann Vasc Dis 2012; 5: 416-22.

Vasculab Journal of Theoretical and Applied Vascular Research (page 32) - JTAVR 2018;3(1):25-32 C Recek - How to counteract the saphenous reflux recurrence

VENOUS PATHOPHYSIOLOGY SHORT COMMUNICATION The tenacious tendency to saphenous reflux recurrence and the possibility how to counteract it

C Recek1

1 Retired, formerly Department of Surgery, University Hospital, Hradec Kralove, Czech Republic. Address: Cestmir Recek, Mantlergasse 24, 1130 Vienna, Austria.

submitted: Jan 15, 2019, accepted: Jan 20, 2019, EPub Ahead of Print: Jan 21, 2019, published: Jul 7, 2019 Conflict of interest: None

DOI: 10.24019/jtavr.60 - Corresponding author:Dr. Cestmir Recek, [email protected]

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

Abstract Varicose vein disease is characterized Introduction by a tenacious tendency to recurrence irrespective of the therapeutic method used; recurrent reflux is Varicose vein recurrences were reported to occur inextricably linked with recurrent and in a wide range up to 90% depending on the length of is responsible for the progressive deterioration of the follow-up, the mode of therapy, and the method used to hemodynamic disorders. The hemodynamic preconditions diagnose recurrence1-5. Inadequate surgery leaving behind for the development of recurrent reflux are generated incompetent saphenofemoral junction with tributaries or during calf pump activity by the pathological drainage of incompetent trunk of the in the venous blood from the incompetent thigh saphenous system thigh has been claimed to cause recurrence of saphenous into deep lower leg veins; the consequence is relocation reflux and varicose veins6-8. Nevertheless, recurrences of the dividing line of the ambulatory pressure gradient occur also after correctly performed crossectomy and from below the knee joint where it is situated in healthy 9-11 people into the thigh between the femoral vein and the stripping . Even special measures, such as suturing incompetent thigh saphenous system, which sets off the the foramen ovale and inserting mechanical barriers over chain of events producing recurrent reflux. This undesirable the saphenofemoral junction were not able to prevent entanglement can be counteracted by interruption of the recurrences12-18. Some authors expressed the opinion that venous drainage at the level of the knee joint, where it is recurrent reflux in varicose vein disease was unavoidable, easiest and most effectively feasible. This can be achieved no matter how careful the primary procedure was carried by surgical procedures, ablative methods or sclerotherapy. out, and postulated that the tendency of varicose veins With reference to the behavior of pressure changes in to recur might be related to unspecified hemodynamic deep and superficial veins of the lower extremity occurring factors6, 19. during calf pump activity it can be deduced that external pressure of about 35 mm Hg applied just below the This article mentions the hemodynamic phenomenon knee joint (e. g. by a rubber sleeve) might constitute an triggering recurrence of saphenous reflux and reflects on alternative therapeutic possibility; its effectiveness should measures how to prevent it. be verified in clinical studies. If proved to be effective and tolerated by the patients, it would not only inhibit The tenacious tendency to generate recurrent saphenous reflux in varicose vein disease but impede also reflux the occurrence of hemodynamic preconditions responsible for the development of recurrent reflux. Varicose vein disease has a tenacious tendency to recurrence, as documented in many papers1-18. The Keywords recurrent reflux, external compression of progressively increasing intensity of recurrent saphenous the saphenous vein reflux is responsible for the gradually deterioration of

Vasculab Journal of Theoretical and Applied Vascular Research (page 33) - JTAVR 2018;3(1):33-36 C Recek - How to counteract the saphenous reflux recurrence the hemodynamic disturbance and the re-occurrence of veins. This can be achieved either by invasive procedures or chronic venous insufficiency. Nevertheless, in the course by conservative measures. During the surgical procedure, of the follow-up of 34 years, only 21.6% of limbs with the easiest mode is precluding the drainage at the “strait”, recurrent reflux after primary surgery displayed congestive i. e. at the knee level. All incompetent superficial veins symptoms severe enough to necessitate reoperation11. must pass this bottleneck between the skin and the bones or muscles and are here easiest therapeutically assailable. Venous reflux is triggered by the ambulatory pressure Together with the abolition of saphenous reflux at the gradient of 37.4 ± 6.4 mm Hg arising during calf pump saphenofemoral junction all incompetent venous channels activity between thigh veins with higher pressure and lower identified preoperatively by duplex ultrasonography should leg veins with lower pressure20. Thus, the origin of reflux be interrupted in this bottleneck; the surgical procedure 27 is situated always above the knee, the mouth/re-entry point aiming at this goal has been published previously . below the knee. In primary varicose veins with impeccable Notwithstanding, new draining channels may develop in the competence of deep lower leg veins the calf perforators course of follow-up; they should be checked at the knee can never become the source of reflux because they are level during the follow-up examinations and obliterated by connected to the lower pole of the ambulatory pressure sclerotherapy, if necessary. gradient. The dividing line of the ambulatory pressure gradient is situated in healthy people just below the knee Apart from the invasive procedures, a sheer joint at the beginning of the popliteal vein. Abolition conservative measure might produce similar beneficial of saphenous reflux in varicose vein disease eliminates hemodynamic results. Based on the behavior of pressure the hemodynamic disturbance even in patients afflicted changes in deep and superficial veins of the lower extremity with the severest degree of chronic venous insufficiency occurring during calf pump activity, it can be deduced that and restores physiological hemodynamic values but, oddly the same goal might be achieved by the external pressure enough, at the same time it generates preconditions for the applied in the form of a pneumatic cuff or a rubber sleeve development of reflux recurrence and for the progressive closely below the knee joint. The pressure of about 35 mm comeback of the previous pathological situation; this Hg might be able to compress the saphenous system during 21 the diastolic phase of the calf pump activity and impede in phenomenon has been called hemodynamic paradox . this way the saphenous reflux. It follows that it would The hemodynamic preconditions for reflux recurrence are - 1. Hinder the diastolic saphenous reflux and the induced during calf pump activity by the drainage of venous occurrence of ambulatory venous hypertension blood from the thigh saphenous system into the deep lower - 2. Enable the physiological systolic centripetal leg veins; the consequence is relocation of the dividing flow line of the ambulatory pressure gradient from below the - 3. Hinder the pathological drainage from the knee into the thigh between the femoral vein and the thigh saphenous system into deep lower leg veins incompetent thigh saphenous system. This situation triggers occurring during calf pump activity in the treated the chain of events engendering the occurrence of recurrent patients in whom saphenous reflux was abolished, reflux: pressure gradient –> increased flow through the and inhibit thereby the creation of preconditions tiny communicating vessels –> increased fluid shear stress triggering recurrent reflux. on the endothelium –> release of vasoactive agents – As mentioned above, the saphenous reflux is triggered in > progressive dilatation of the concerned vessels22-26. the vertical/standing position by the ambulatory pressure The relocation of the dividing line of the ambulatory gradient. During calf pump activity, the hydrostatic venous pressure gradient is the characteristic feature of varicose pressure decreases to about 25 mm Hg in the distal posterior vein disease; it does not arise in subjects with healthy tibial vein and to about 37 mm Hg in the great saphenous venous system because competent valves preclude the vein above the ankle; the diastolic pressure in the saphenous drainage of venous blood from the thigh into the lower system closely below the knee may be still lower (it leg. Therefore, no pressure difference between the femoral was apparently not measured directly). During calf muscle vein and the superficial veins in the thigh can arise contractions the systolic pressure increases by roughly 35 during calf pump activity in people with healthy veins, mm Hg in the great saphenous vein above the ankle and and no neovascularisation occurs after harvesting the great by 50 mm Hg or more in the posterior tibial vein, so that saphenous vein for bypass grafts the systolic centripetal flow toward the heart is guaranteed; external compression of about 35 mm Hg cannot hinder it. Measures counteracting the tenacious The Perthes test – applying a tourniquet in the thigh in order tendency to reflux recurrence to compress the incompetent saphenous vein – documents that: the bulging varicose veins in the lower leg empty The problem-solving strategy is based on hindering during calf pump activity. The pressure in the popliteal vein the pathological drainage of venous blood from the keeps the value of the hydrostatic pressure of 60 mm Hg; it incompetent thigh saphenous system into the deep lower leg displays small systolic and diastolic oscillations during calf

Vasculab Journal of Theoretical and Applied Vascular Research (page 34) - JTAVR 2018;3(1):33-36 C Recek - How to counteract the saphenous reflux recurrence pump activity but does not decrease28, 29. Adding up the Based on the results of the pressure measurements in ambulatory pressure (37 mm Hg) and the external pressure superficial and deep veins of the lower extremity it can (35 mm Hg) yields the sum of 72 mm Hg, i.e. it exceeds be deduced that external pressure of about 35 mm Hg slightly the pressure in the popliteal vein. Thus, the external applied closely below the knee joint would be able to inhibit pressure of 35 mm Hg would keep the dividing line of saphenous reflux occurring in the diastolic phase of the calf the ambulatory pressure gradient below the knee, as it is pump activity and, in addition, antagonize the tenacious distinctive of healthy people. tendency to the development of recurrent reflux.

This principle could set a new therapy modality in the References treatment of varicose vein disease. It would be meritorious to verify this theoretical idea and specify the value of the 1) Fischer R, Linde N, Duff C, et al. Late recurrent saphenofemoral junction reflux after ligation and stripping of the external pressure necessary to achieve the designated aim. greater saphenous vein. J Vasc Surg 2001; 34:236–240.

Similar effect could be theoretically achieved by 2) Kostas T, Ioannou CV, Touloupakis E, et al. Recurrent the so called hydrostatic therapeutic device consisting varicose veins after surgery: a new appraisal of a common and complex of a small sleeve of plastic material applied below the problem in vascular surgery. Eur J Vasc Endovasc Surg 2004; 27:275– knee joint; the sleeve is connected to a small-caliber flat 282. incompressible tube reaching into the axilla. If the whole 3) Winterborn RJ, Foy C, Earnshaw JJ. Causes of varicose vein device is filled with water, it exhibits in the standing recurrence: late results of a randomized controlled trial of stripping the position hydrostatic pressure of about 60 mm Hg below long saphenous vein. J Vasc Surg 2004; 40:634–639. the knee joint; this pressure is able to effectively compress 4) Hartmann K, Klode J, Pfister R, et al. Recurrent varicose the saphenous system during the diastolic phase and hinder veins: sonography-based re-examination of 210 patients 14 years after thereby the saphenous reflux taking place during the ligation and saphenous vein stripping. Vasa 2006; 35:21–26. diastolic phase. Another advantage of this device – in contrast to the pneumatic cuff or rubber sleeve - is that the 5) Allegra C, Antignani PL, Carlizza A. Recurrent varicose veins pressure in the hydrostatic device decreases in the sitting following surgical treatment: our experience with five years follow-up. Eur J Vasc Endovasc Surg 2007; 33:751–756. position and reaches near zero in the recumbent position. 6) El Wajeh Y, Giannoukas AD, Gulliford CJ, et al. Progressive elastic compression stockings Saphenofemoral venous channels associated with recurrent veins are not neovascular. Eur J Vasc Endovasc Surg 2004; 28:590–594. The effect of the so called progressive elastic 30 7) Geier B, Stücker M, Hummel T, et al. Residual stumps compression stockings published by Mosti and Partsch associated with inguinal varicose vein recurrence: a multicenter study. conforms to the same principle. The authors used Eur J Vasc Endovasc Surg 2008; 36:207–210. plethysmography under a standardized walking test and reported that significantly better improvement of ejection 8) Bradbury AW, Stonebridge PA, Callam MJ, et al. Recurrent varicose veins: assessment of the saphenofemoral junction. Br J Surg fraction was found in patients with higher pressure over the 1994;81:373–375. calf than above the ankle, in comparison with conventional graduated pressure profile with higher pressure in the gaiter 9) Frings N, Nelle A, Tran P, Glowacki P. Unavoidable area and lower pressure in the calf. The progressive elastic recurrence and neoreflux after correctly performed ligation of the compression stockings exerting compression pressure of 33 saphenofemoral junction: neovascularization? (German). Phlebologie 2003:32:96- 100. mm Hg in the gaiter area and 46 mm Hg at the calf level led to a pronounced improvement of the venous hemodynamics 10) Frings N, Nelle A, Tran P, et al. Reduction of neoreflux and returned the ejection fraction to or near the normal after correctly performed ligation of the saphenofemoral junction. A range. randomized study. Eur J Vasc Endovasc Surg 2004:28:246-252. 11) Fischer R. Unde N, Duff C, Jeanneret C, et al. Late recurrent Conclusion saphenofemoral junction reflux after ligation and stripping of the greater saphenous vein. J Vasc Surg 200;34:236-240. Drainage of venous blood from the incompetent thigh saphenous system into deep lower leg veins arising 12) Glass GM. Prevention of sapheno-femoral and sapheno- during calf pump activity creates preconditions for the popliteal recurrence of varicose veins by forming a partition to contain development of recurrent reflux and is responsible for the neovascularization. Phlebology 1998:13:3-9. tenacious tendency to reflux recurrence. The interruption 13) Sheppard M. A procedure for the prevention of recurrent of this drainage would keep the dividing line of the saphenofemoral incompetence. Aust NZJ Surg 1978;48:322-326. ambulatory pressure gradient below the knee, as it is distinctive of subjects with healthy veins, and would hinder 14) Gibbs PJ, Foy DM, Darke SG. Reoperation for recurrent saphenofemoral incompetence: a prospective randomised trial using the emergence of recurrent reflux. This can be achieved by a reflected flap of pectineous fascia. Eur J Vasc Endovasc Surg surgical procedures, ablative methods, and sclerotherapy. 1999:18:494-498.

Vasculab Journal of Theoretical and Applied Vascular Research (page 35) - JTAVR 2018;3(1):33-36 C Recek - How to counteract the saphenous reflux recurrence

15) De Maeseneer MC, PhilipsenTE, Vandenbroeck CP, et al. 23) Pipp F, Boehm S, Cai WJ, et al. Elevated fluid shear stress Closure of the cribriform fascia: an efficient anatomical barrier against enhances postocclusive collateral artery growth and gene expression in postoperative neovascularisation at the saphenofemoral junction? A the pig hind limb. Arterioscler Thromb Vasc Biol 2004;24:1664-1668. prospective study. Eur J Vasc Endovasc Surg 2001;34:361- 366. 24) Schaper W, Scholz D. Factors regulating arteriogenesis. 16) Earnshaw JJ, Davies B. Harradine K. Heather BP. Arteriosler Thromb Vasc Biol 2003:23:1143-1151. Preliminary results of PTFE patch saphenoplasty to prevent neovascularization leading to recurrent varicose veins. Phlebology 25) Resnick N, Gimbrone MA Jr. Hemodynamic forces 1998;13:10-13. are complex regulators of endothelial gene expression. FASEB J 1995;9:874-882.

17) Bhatti TS, Whitman B, Harradine K, et al. Causes of 26) Schierling W, Troidl K, Troidl C, et al. The role re-recurrence after polytetrafluorethylene patch saphenoplasty for of angiogenic growth factors in arteriogenesis. J Vasc Res recurrent varicose veins. Br J Surg 2000;87:1350-1360. 2009;46:365-374.

18) Winterborn RJ, Earnshaw JJ. Randomized trial of 27) Recek C. Hemodynamics-based treatment of varices: A polytetrafluorethylene patch insertion for recurrent great saphenous therapeutic concept counteracting the intrinsic tendency of varicose varicose veins. Eur J Vasc Endovasc Surg 2001:34:367-313. veins to recur. Phlebology 2016;31:704-711.

19) Turton EP, Scott DJ, Richards SP, et al. Duplex- 28) Arnoldi CC. Venous pressure in the leg of healthy human derived evidence of reflux after varicose vein surgery: neoreflux or subjects at rest and during muscular exercise in nearly erect position. neovascularisation? Eur J Vasc Endovasc Surg 1999; 17:230-233. Acta Chir Scand 1965;130:573-583.

20) Recek C, Pojer H. Ambulatory pressure gradient in the veins 29) Arnoldi CC. Venous pressure in patients with valvular of the lower extremity. VASA 2000; 9:187-90. incompetence of the veins of the lower limb. Acta Chir Scand 1966; 132:628–645. 21) Recek C. The hemodynamic paradox as a phenomenon triggering recurrent reflux in varicose vein disease. Int J Angiol 30) Mosti G, Partsch H. Improvement of venous pumping 2012;21:181-185. function by double progressive compression stockings: higher pressure over the calf is more important than a graduated pressure profile. 22) Schaper W. Collateral circulation: past and present. Basic Eur J Vasc Endovasc Surg. 2014 May;47(5):545-9. doi: 10.1016/ Res Cardiol 2009;104:5-21. j.ejvs.2014.01.006. Epub 2014 Feb 10.

Vasculab Journal of Theoretical and Applied Vascular Research (page 36) - JTAVR 2018;3(1):33-36 FP Faccini, JMC Souza, AL Arendt - Popliteal occlusion after focused ultrasound

HIGH INTENSITY FOCUSED ULTRASOUND CASE REPORT Occlusion of the popliteal artery after focused ultrasound treatment - a case report

FP Faccini1, JMC Souza2, AL Arendt3

1 Vascular Surgery - Hospital Moinhos de Vento and Instituto de Cardiologia, Porto Alegre, Brasil 2 Clínica Angiovasc, Aracaju, Sergipe, Brasil 3 Vascular Surgery - Hospital Moinhos de Vento and Instituto de Cardiologia, Porto Alegre, Brasil

submitted: Jun 20, 2019, accepted: Jul 2, 2019, EPub Ahead of Print: Jul 3, 2019, published: Jul 7, 2019 Conflict of interest: None

DOI: 10.24019/jtavr.65 - Corresponding author:Dr. Felipe Puricelli Faccini, [email protected], [email protected]

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

Abstract The use of focused ultrasound and high- using the mechanism of tissue heating1. Over the following intensity focused ultrasound (HIFU) is common in physical decades, scientific advances allowed the development of therapy and medical procedures. The ultrasound produces better methods for effective treatment of several disease. heat and can be used to treat several diseases. We report a Since the 1970's, the use of therapeutic ultrasound was case of a 49-year-old male that had a knee injury after mild established for kinesiotherapy. The continuous ultrasound trauma. The patient started physical therapy sessions to treat waves produce localized heating and consequently protein the injury. Ipsilateral calf claudication started a few hours denaturation causing thermal ablation2. The more the power after the focused ultrasound was used to heat the popliteal 1 area progressing to symptoms of acute arterial occlusion the more the likelihood and magnitude of bioeffects . in two weeks. We started anticoagulation and confirmed The use for hemostasis of punctured arteries has achieved popliteal with duplex scan and computed promising results in animal studies3,4. Spleen and liver tomography. The 5 years follow up showed good clinical hemostasis have also been successfully achieved using recovery and recanalization of the artery. This case reminds HIFU in animals5-7. The long term effects of most us that the focused ultrasound should not be considered Focused Ultrasound and HIFU treatments are still unknown harmless and life-threatening complications may occur. and knowledge about complications of its use is scarce. The inadvertent heating of neighboring structures and The ultrasound technology has been proved to perform recanalization of the heated vessel may happen. thermal ablation on veins8 and recently the technique Keywords High intensity focused ultrasound, is being performed to obtain thermal ablation of the Acute arterial occlusion, Popliteal artery occlusion, saphenous and varicose veins. The focus of the ultrasound Thermoablation, Recanalization beam is pivotal to obtain the expected results without complications. Although the ultrasound is considered safe, the produced heat can cause injury to structures not intended 1 Introduction to be damaged , like arteries and nerves that usually are anatomically close to veins. This possibility was considered Focused ultrasound and High-Intensity Focused by Henderson et al and described in an ex-vivo study9. Ultrasound (HIFU) have been increasingly used in vascular surgery to control hemorrhage and to produce thermal The use of focused ultrasound in physical therapy damage in vessels when it is desirable. In the mid twentieth is well established and complications are rare, although century various conditions were considered possibilities for the level of efficacy is modest and patient benefits are

Vasculab Journal of Theoretical and Applied Vascular Research (page 37) - JTAVR 2018;3(1):37-40 FP Faccini, JMC Souza, AL Arendt - Popliteal occlusion after focused ultrasound uncertain1. We report a case of popliteal artery thrombosis or endovascular treatment was performed. Concerning the after focused ultrasound therapy. Ultrasound biophysics, equipment and protocol used to perform the session of complications and uses in vascular surgery of both focused kinesiotherapy with focused ultrasound, they are pivotal and high-intensity focused ultrasound are discussed. to better understand the damage. The probe used in the knee region had a frequency of 1,0 MHz using continuous Case report ultrasound and surface power density of 2.0 w/cm². The patient told us the duration of ultrasound was close to 30 A 49-year-old male presented to the clinic with left minutes but we could not obtain the complete details. leg pain, coldness and paleness with no sensory loss, no muscle weakness and audible arterial and venous Doppler. We noticed an unusual coloring at the skin of the popliteal region only, not related to areas of ischemia. Medical history showed a mild fall injury to the knee 4 months before and focused ultrasound during physical therapy sessions for bone healing two weeks before the vascular appointment. The patient referred intermittent claudication and leg coldness starting a few hours after a session of physical therapy in which the focused ultrasound was used.

The progression to severe symptoms of ischemia have happened 2 weeks later. The duplex scan (Figure 1) showed popliteal thrombosis and computed tomography showed 8 cm of unusual obstruction of the popliteal artery at the knee region (Figure 2). As we did not operate the patient, no histologic sample is available. Initially, we considered that the cause of arterial occlusion was either arterial trauma or burning from the ultrasound used to heat the region. Literature review about arterial damage after knee injury suggests that the onset of arterial occlusion was Figure 1 - No flow with Color Doppler in the popliteal late to blame trauma alone. Most literature reports and case artery at the first access. series present occlusion in the first hours or few days after Discussion trauma10 and our patient presented occlusion more than 4 months after trauma. Ultrasonic energy can provoke biological effects creating heat that can be used to treat diseases. Additionally, Although, we consider that the trauma might have ultrasound causes cavitation with microbubbles, increase of been an adjunct factor due to the possibility that a hematoma gas body activation, radiation force (mechanical stress), and change the position and mobility of the artery. Embolism other undetermined non-thermal processes1,11. All these and atherosclerosis were excluded by careful cardiac and effects create desired and undesired biological responses arterial evaluation. The symptoms prior to the focused during the medical application of ultrasound. ultrasound were articular pain depending on the position of the knee and changed completely after the session. The diseases in which ultrasound is used for treatment are kidney stones with the lithotripsy; lens We started anticoagulation and close observation. removal with the phacoemulsification; bone fracture with The symptoms of acute ischemia improved in a few hours. the low intensity US; plantar fasciitis and epicondylitis After the improvement of the first days we suspended with the extracorporeal shockwaves therapy; uterine heparin and started clopidogrel. The patient remained with fibroid ablation, glaucoma, laparoscopic tissue ablation or intermittent claudication for long distances after 1 week laparoscopic or open surgery - all this with HIFU, among until now and continued stable for the last 5 years. others uses1. We decided to avoid invasive treatment with patient’s The rate of serious complications after the focused agreement. We do not have large experience with burning ultrasound is considered very low and the procedures are arterial lesions and decided to avoid further treatment common, although no large studies on safety are available1. because the symptoms were stable and not bothering the Serious complications as injury to artery, nerves or veins patient. One year after the treatment the patient had another are considered rare. We have not found any report in the CT scan that showed complete recanalization of the artery literature of popliteal artery occlusion caused by ultrasound. with 2 narrowing areas of 2 cm each (Figure 3). No surgical

Vasculab Journal of Theoretical and Applied Vascular Research (page 38) - JTAVR 2018;3(1):37-40 FP Faccini, JMC Souza, AL Arendt - Popliteal occlusion after focused ultrasound

Figure 2 - Computed tomography image confirming the Figure 3 - Computed tomography 1 year after the first obstruction at the popliteal artery. examination with focal at knee level.

This is probably an extremely rare complication vessels by echo contrast and beam control, but the results because most focused ultrasounds are not used near are still initial12. One experimental study in rabbits showed important arteries or structures. In our isolated clinical case that the HIFU can close by thermal ablation veins as large we have noticed that the symptoms in the occlusion after as 6 mm with 15 days of follow up13. Obermayer has ultrasound were not abrupt as in most arterial occlusions, recently shown that HIFU can cause thermal ablation of maybe because the processes developed with progressive varicose veins, perforators and great saphenous veins. No tissue edema before the full occlusion. The use of HIFU for long term results are available to ensure the safety and venous ablation has been studied for a few years. Henderson 14 et al described a portable equipment that successfully benefit for the patients using the method . In our case, the patient had complete occlusion of the popliteal artery after ablated veins in an ex-vivo study9. Experimental studies ultrasound and full recanalization in months, this might have also searched for ways to focus the damage to specific

Vasculab Journal of Theoretical and Applied Vascular Research (page 39) - JTAVR 2018;3(1):37-40 FP Faccini, JMC Souza, AL Arendt - Popliteal occlusion after focused ultrasound happen with the veins closed. We expected a definitive techniques that can be used in a variety of medical arterial occlusion, but time proved we were wrong. conditions. The use of the ultrasound wave is generally safe but serious complications might happen and we High intensity focused ultrasound HIFU is newer than should always consider that the neighboring structures focused ultrasound and the procedures are still being made might be affected by the heating effect or non-thermal under controlled trials in the majority of fields. There is no effects. Therefore, It is important to accurately determine available data for the safety of HIFU in vascular procedures. the location and control the treatment zone with the Obermayer treated varicose veins and reported 4 legs out of ultrasound system8. The possibility to treat venous disease 50 with dysesthesias suggesting damage to nerves. No deep by ultrasound is exciting and should be deeply studied. vein thrombosis, pulmonary embolism or arterial damage Although, we should keep in mind that undesirable and even 14 were reported in the initial cases . Our case reminds us that life-threatening conditions can occur. Safety studies on the the energy created by ultrasound can damage neighboring new techniques are imperative to validate their use both structures as well as the treated vessel. in terms of safety and long-term benefit of the treatment. In our case we observed both the undesirable occlusion Conclusion of an important artery and its fast recanalization without intervention In conclusion, the focused ultrasound and high- intensity focused ultrasound (HIFU) are important

References 1) Miller DL, Smith NB, Bailey MR, Czarnota GJ, Hynynen element analysis and phantom validation. Comput Methods Biomech K, Makin IRS, et al. Overview of therapeutic ultrasound applications Biomed Engin [Internet]. 2012;15(4):323–32. Available from: https:// and safety considerations. J Ultrasound Med [Internet]. 2012 doi.org/10.1080/10255842.2010.535521 at the date of Jun 20, 2019. Apr;31(4):623–34. Available from: https://www.ncbi.nlm.nih.gov/ pubmed/22441920 at the date of Jun 20, 2019. 9) Henderson PW, Lewis GK, Shaikh N, Sohn A, Weinstein AL, Olbricht WL, et al. A portable high-intensity focused ultrasound 2) Webb H, Lubner MG, Hinshaw JL. Thermal ablation. Semin device for noninvasive venous ablation. J Vasc Surg [Internet]. Roentgenol [Internet]. 2011 Apr;46(2):133–41. Available from: https:// 2010 Mar;51(3):707–11. Available from: https://doi.org/10.1016/ doi.org/10.1053/j.ro.2010.08.002 at the date of Jun 20, 2019. j.jvs.2009.10.049 at the date of Jun 20, 2019.

3) Zderic V, Keshavarzi A, Noble ML, Paun M, Sharar 10) Kim J-W, Sung C-M, Cho S-H, Hwang S-C. Vascular SR, Crum LA, et al. Hemorrhage control in arteries using high- injury associated with blunt trauma without dislocation of the knee. intensity focused ultrasound: A survival study [Internet]. Vol. 44, Yonsei Med J [Internet]. 2010 Sep;51(5):790–2. Available from: Ultrasonics. 2006. p. 46–53. Available from: https://doi.org/10.1016/ https://doi.org/10.3349/ymj.2010.51.5.790 at the date of Jun 20, 2019. j.ultras.2005.08.002 at the date of Jun 20, 2019. 11) O’Brien WD Jr. Ultrasound-biophysics mechanisms. Prog Biophys Mol Biol [Internet]. 2007 Jan;93(1-3):212–55. Available from: 4) Martin RW, Vaezy S, Kaczkowski P, Keilman G, Carter S, https://doi.org/10.1016/j.pbiomolbio.2006.07.010 at the date of Jun 20, Caps M, et al. Hemostasis of punctured vessels using Doppler-guided 2019. high-intensity ultrasound [Internet]. Vol. 25, Ultrasound in Medicine & Biology. 1999. p. 985–90. Available from: https://doi.org/10.1016/ 12) Tokarczyk A, Rivens I, van Bavel E, Symonds- s0301-5629(99)00027-7 at the date of Jun 20, 2019. Tayler R, ter Haar G. An experimental system for the study of ultrasound exposure of isolated blood vessels. Phys Med Biol 5) Noble ML, Vaezy S, Keshavarzi A, Paun M, Prokop AF, [Internet]. 2013 Apr 7;58(7):2281–304. Available from: https:// Chi EY, et al. Spleen Hemostasis Using High-Intensity Ultrasound: doi.org/10.1088/0031-9155/58/7/2281 at the date of Jun 20, 2019. Survival and Healing [Internet]. Vol. 53, The Journal of Trauma: Injury, Infection, and Critical Care. 2002. p. 1115–20. Available from: https:// 13) Barnat N, Grisey A, Lecuelle B, Anquez J, Gerold B, doi.org/10.1097/00005373-200212000-00014 at the date of Jun 20, Yon S, et al. Noninvasive vascular occlusion with HIFU for venous 2019. insufficiency treatment: preclinical feasibility experience in rabbits. Phys Med Biol [Internet]. 2019 Jan 7;64(2):025003. Available from: 6) Burgess S, Zderic V, Vaezy S. Image-guided acoustic https://doi.org/10.1088/1361-6560/aaf58d at the date of Jun 20, 2019. hemostasis for hemorrhage in the posterior liver. Ultrasound Med Biol [Internet]. 2007 Jan;33(1):113–9. Available from: https:// 14) Obermayer A. Ultrasound-Guided High-Intensity doi.org/10.1016/j.ultrasmedbio.2006.07.025 at the date of Jun 20, 2019. Focused Ultrasound Extracorporeal Treatment of Superficial Lower Limb Veins: Preliminary Results and Method 7) Vaezy S, Vaezy S, Starr F, Chi E, Cornejo C, Crum Description. Journal of Vascular Surgery: Venous L, et al. Intra-operative acoustic hemostasis of liver: production and Lymphatic Disorders [Internet]. 2018;6(4):556–7. of a homogenate for effective treatment. Ultrasonics [Internet]. Available from: https://www.jvsvenous.org/action/showCitFormats? 2005 Feb;43(4):265–9. Available from: https://doi.org/10.1016/ pii=S2213-333X j.ultras.2004.07.002 at the date of Jun 20, 2019. %2818%2930168-9&doi=10.1016%2Fj.jvsv.2018.05.007 at the date of Jun 20, 2019. 8) Jiang C-P, Wu M-C, Wu Y-S. Inducing occlusion effect in Y-shaped vessels using high-intensity focused ultrasound: finite

Vasculab Journal of Theoretical and Applied Vascular Research (page 40) - JTAVR 2018;3(1):37-40 Memorial pages

Memorial pages

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

et la perfection du corps humain en tant que création divine In memory of Prof. Claude Gillot d’où sa passion pour l’anatomie. C’est pourquoi il a dédié toute sa vie à l’étude de l’anatomie, à l’enseignement et à la recherche.

JF Uhl1 Claude était un enseignant hors du commun qui jusqu’a 91 ans allait tous les matins donner son cours aux jeunes étudiants de la faculté de médecine des Saints pères, * Vascular surgeon, member of the French Academy puis il allait disséquer l’après-midi… of Surgery. URDIA research unit EA4465 - Laboratory Ses qualités de chercheur étaient tout aussi of Anatomy (Paris cité Sorbonne University). Research remarquables, réexaminant inlassablement son énorme Director, UNESCO Chair of Digital Anatomy collection de coupes anatomiques et ses photos de submitted: Jul 02, 2018, accepted: Jul 02, 2018, EPub dissection. Il avait mis au point la technique de la Ahead of Print: Dec 9, 2018, published: Jul 7, 2019 segmentation colorée pour les rendre accessibles à tous. Ceci représente un travail titanesque: Lavage puis injection DOI: 10.24019/jtavr.50 - Corresponding author: des veines au latex, dissection anatomique, identification Prof. Jean François Uhl, [email protected], puis peinture de chaque veine avec une couleur spécifique. [email protected] Ce travail qui demande des centaines d’heures pour chaque membre inférieur, et il l’a réalisé sur plus de 400 membres… © 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

Figure 2 - Couverture de l'Atlas-livre de C Gillot. [Cover Figure 1 - Prof. Claude Gillot of the Atlas-book of C Gillot] FRANCAIS Un des travaux majeurs de Claude Gillot est son atlas d'anatomie du réseau superficiel des membres inférieurs. Nous nous devons tous de rendre un vibrant hommage à notre Maître et ami le Professeur Claude GILLOT qui C'est un très grand livre, par sa taille et son vient de nous quitter. contenu. Claude Gillot a réalisé là l'étude la plus complète sur les veines superficielles. Les nombreuses planches Médecins, Phlébologues, Chirurgiens vasculaires, sont dessinées d'après des dissections réelles. (Editions échographistes et anatomistes utilisent en effet au quotidien phlébologiques Françaises - épuisé) l’énorme quantité de connaissances qu’il a accumulé sur l’anatomie en général, et le système veineux en particulier. Un CD-Rom a été fait à partir de cet Atlas en Claude GILLOT était un grand croyant fasciné par la beauté Français - Anglais -Espagnol téléchargeable sur mon site

Vasculab Journal of Theoretical and Applied Vascular Research (page 41) - JTAVR 2018;3(1) Memorial pages internet (www.jfuhl.com), un must à recommander à tous We all must pay a trembling tribute to our Master les amateurs de veines and friend, Professor Claude GILLOT who recently passed away.

Physicians, phlebologists, vascular surgeons, ultra- sonographers and anatomists practically adopt daily the great amount of knowledge that He collected generally about anatomy and especially about the venous system. Claude GILLOT was a great believer, fascinated by the beauty and the perfection of the human body as a divine creation, therefore his passion for anatomy.

That’s the reason why He committed all his life to the study of anatomy, to teaching and to research.

Claude was an outstanding teacher, who until 91 yo Figure 3 - Planche colorée in-folio d'après dissection went every morning to give his class to young students of représentant le réseau veineux superficiel de cuisse. La the Department of Medicine of Saints Pères, thereafter He segmentation colorée permet aisément d'identifier le tronc went to make dissections in the afternoon… de la grande veine saphène (bleu clair), celui de la His traits of researcher were all also remarkable, re- saphène accessoire antérieure (mauve) et de la saphène examining tirelessly his huge collection of anatomical slices accessoire postérieure (grenat). [Coloured in-folio table and his dissection photos. He developed the technique of according to a dissection representative of the superficial coloured segmentation in order to make it available to venous network of the thigh. The coloured segmentation everyone. It is a titanic work: washing and then venous easily allows the identification of the trunk of the great injection with latex, anatomic dissection, identification, saphenous vein (light bleu), the ones of the anterior then painting each vein with a specific colour. This work accessory saphenous vein (purple) and posterior accessory requires hundreds of hours for each lower limb, and He saphenous vein (dark red).] carried out more than 400 limbs…

Mais le plus remarquable est sans doute sa passion One of the main works of Claude Gillot is his Atlas pour la recherche qui l’a conduit jusqu’au dernier jour à de of anatomy of the superficial network of the lower limbs. nouvelles découvertes. It is a very great book, I mean very big dimensions C’est ainsi qu’après 90 ans, il se passionnait pour and great content. Claude Gillot carried out the most le canal de Hunter, les arcades veineuses du semi- complete study on the superficial veins. The many tables membraneux et tout dernièrement les perforantes osseuses are drawn in agreement with real dissections. (Editions du genou qu’il a mis en évidence en examinant des coupes phlébologiques Françaises – out of stock) datant de plus de 20 ans: “En anatomie, le plus difficile c’est de voir ce que l’on a sous les yeux” aimait-il répéter. A CD-Rom was produced from the Atlas in French – English – Spanish, downloadable on my web site Claude a gardé jusqu’au dernier moment, malgré ses (www.jfuhl.com), a «must » recommended to all venous soucis de santé, une ouverture d’esprit qui devrait nous fans. servir d’exemple à tous… But undoubtedly the most impressive was his passion Enfin, Claude GILLOT était un homme d’une grande for the research, which drove him until the last day of his modestie et d’une immense gentillesse, et pour cette raison, life to new discoveries. aimé de tous. It is in this way that aged more than 90 years He Je mesure pleinement la grande chance qui m’a été was captivated by the Hunter’s canal, the venous arches of donnée d’être son élève, me permettant de partager ses the semi-membranous muscle and ultimately by the knee immenses connaissances en anatomie humaine, ce qu’il bony perforating veins, which He highlighted examining faisait avec humilité et simplicité. anatomic slices dating to more than 20 years: “In anatomy, the most difficult job is to see what is under our own eyes” Au revoir, mon cher Claude, tu seras présent à jamais He loved to repeat. dans notre cœur. Though his health problems, Claude preserved until ENGLISH the last moment his open-mindedness, which should be an example to everyone…

Vasculab Journal of Theoretical and Applied Vascular Research (page 42) - JTAVR 2018;3(1) Memorial pages

Finally, Claude Gillot was a man of great modesty In quegli anni il Prof Fiorani frequenta come “fellow” and immense kindness and, for that reason, loved by all. il Baylor College of Medicine a Houston, presso il Dipartimento di Chirurgia Cardio-vascolare diretto dal I wholeheartedly consider the great opportunity grande Prof Michael De Backey. which I was gifted being his disciple, allowing me to share his immense knowledge in human anatomy, that he did with Tornato in Italia, Egli porta nella chirurgia vascolare humility and simplicity. italiana quanto appreso e sperimentato negli Stati ‘Au revoir, mon cher Claude’, you will be forever Uniti, dando così il via alla ricerca clinica nei settori present in our heart. della chirurgia vascolare in veloce espansione (chirurgia dell’arteria renale e ipertensione renovascolare; chirurgia Docteur Jean-François UHL della carotide ed insufficienza cerebrovascolare; patologia arteriosa degli arti). Inoltre, può essere considerato pioniere della chirurgia dell’aorta addominale in Italia. Professor Paolo Fiorani: “Maestro” of a Il Prof Fiorani è stato sicuramente uno dei padri della generation of vascular surgeons chirurgia vascolare italiana e ne ha rappresentato i valori in Europa e nel mondo, instaurando scambi costruttivi con i maggiori rappresentanti del settore quali Courbier e Kieffier in Francia, Balas in Grecia, Vollmar in Germania, Prof. Paolo Fiorani: ricordo di un allievo Greenhalgh in Inghilterra, Imparato, Wiley e Veith negli Stati Uniti con i quali ha contribuito al grande sviluppo della C Spartera1 Chirurgia Vascolare Open. Quando poi, negli anni '90, sono state introdotte le 1 Emeritus Professor of Vascular Surgery. Univerisity of tecniche mini invasive, sia chirurgiche che endovascolari, egli ha subito capito l’importanza di tali tecniche, L'Aquila, Italy riconoscendone l’impatto positivo nella pratica clinica e submitted: Oct 17, 2018, accepted: Oct 17, 2018, EPub nella ricerca. Ahead of Print: Dec 9, 2018, published: Jul 7, 2019 Conflict of interest: none Infatti nella Chirurgia Vascolare della 2° clinica chirurgica dell’Università la Sapienza di Roma è stata DOI: 10.24019/jtavr.52 - Corresponding author: Prof. impiantata una endoprotesi aortica (una delle prime in Carlo Spartera, [email protected] Italia) con l'ausilio del suo inventore argentino prof. Parodi.

Con la sua esperienza e sotto la sua guida si è formata © 2018 Fondazione Vasculab impresa sociale ONLUS. [i] All rights reserved. la Scuola di Chirurgia Vascolare Romana (Fig. 2) ed inoltre Egli ha partecipato fattivamente alla fondazione ITALIANO della Società Italiana di Chirurgia Vascolare.

Dal maggio scorso non è più tra noi il Professor Paolo E’ stato il primo italiano ad essere Presidente della Fiorani, chirurgo vascolare, maestro di scienza e di vita. Società Europea di Chirurgia Vascolare, conosciuto e (Fig. 1) stimato anche da colleghi di altre specialità con i quali Il suo curriculum e la sua carriera sono noti a ha collaborato in varie ricerche, tra cui importantissimi gli tutti, essendo stato un punto di riferimento accademico e studi sul circolo cerebrale che ha condiviso con gruppi di chirurgico in questi ultimi 50 anni, periodo eccezionalmente ricerca internazionali, quali quello di Lassen in Danimarca, innovativo nel campo medico e chirurgico, in particolare con la collaborazione e la grande competenza specifica del nella chirurgia vascolare. Prof Pistolese Il Professor Fiorani ha vissuto questi anni in prima E’ stato il primo italiano Socio Onorario della Società linea, da protagonista. Americana di Chirurgia Vascolare. L’avventura inizia negli anni '60, periodo in cui tre Con Lui scompare un pilastro dalle fondamenta della grandi ed illuminati chirurghi, Malan a Milano, Stefanini chirurgia vascolare italiana e noi allievi, G. Raimondo a Roma e Zannini a Napoli, capiscono che è arrivato il Pistolese Università Tor Vergata Roma, Vittorio Faraglia e momento in cui alcune specialità, come la chirurgia dei poi Maurizio Taurino al Sant’Andrea Roma Università la trapianti, la chirurgia toracica e la chirurgia vascolare, Sapienza, Francesco Spaziale al Policlinico Università la si rendano indipendenti sia dal punto di vista clinico- Sapienza Roma ed il sottoscritto all’Università de L’Aquila, chirurgico che accademico. che abbiamo iniziato sotto la sua spinta energica la carriera

Vasculab Journal of Theoretical and Applied Vascular Research (page 43) - JTAVR 2018;3(1) Memorial pages di chirurghi vascolari, ricorderemo sempre la sua sagacia, Ci legava il tifo romanista ed era anche un grande il suo impulso quotidiano a migliorarsi, la sua curiosità sportivo: amava lo sci, il mare e la barca a vela, buon scientifica, le sue intuizioni geniali, doti che hanno fatto di tennista e ottimo golfista nel quale sport si racconta di Lui un vero Maestro. accanite partite col suo grande amico Raimondo Pistolese.

Ma non posso fare a meno, in questa circostanza, di Ora non c’è più, ma credo che il Professor Fiorani ricordare il lato umano del Prof Fiorani: egli amava la vita mancherà molto a tutto il mondo scientifico ed accademico e la convivialità e lo ha dimostrato aprendo la sua casa per italiano ed internazionale. tante cene postcongressuali, con il supporto costante della moglie Paola con cui ha formato una splendida famiglia con 5 figli.

Figure 2 - Fiorani P, Pistolese GR, Spartera C, Faraglia V. Elementi di Patologia e Chirurgia Vascolare. [Basics of Pathology and Vascular Surgery]. Antonio Delfino Ed., 1988. ISBN: 8872870348.

Figure 1 - Prof. Paolo Fiorani

ENGLISH in the field of medicine and surgery, in particular in vascular surgery. Since last May, Professor Paolo Fiorani, vascular surgeon, Maestro of science and of life, has no longer been Professor Fiorani lived these years on the front line, with us. (Fig. 1) as a protagonist. His adventure starts in the 1960s, a period in His curriculum and his career are known to all, which the great and farsighted surgeons Malan in Milan, his having been an academic and surgical reference point Stefanini in Rome and Zannini in Naples, understood that during the last 50 years, an exceptionally innovative period the time had come for some specialities, like transplant

Vasculab Journal of Theoretical and Applied Vascular Research (page 44) - JTAVR 2018;3(1) Memorial pages surgery, thoracic surgery and vascular surgery, to become esteemed by colleagues from other specialities, with whom independent both from a clinical-surgical point of view and he collaborated in various research projects, among the academically. most important of which were the studies of the cerebral blood flow that he shared with the international research In those years Prof. Fiorani was a Fellow of the groups, like that of Lassen in Denmark, with cooperation Baylor College of Medicine in Houston, at the Department and great specific competence of Prof Pistolese. of Cardiovascular Surgery directed by the great Prof. Michael De Backey. He was the first Italian to be an Honorary Member of the American Society of Vascular Surgery. Having returned to Italy, he brought what he had learnt and experienced in the United States to Italian His passing is also the disappearance a foundation vascular surgery, thereby setting off clinical research in pillar of Italian vascular surgery, and we, his former fast-expanding sectors of vascular surgery (surgery of assistants and then colleagues, G. Raimondo Pistolese at the renal artery and renovascular hypertension; carotid Tor Vergata University of Rome, Vittorio Faraglia and then surgery for cerebrovascular insufficiency; peripheral Maurizio Taurino at Sant’Andrea La Sapienza University arterial disease). Besides, he may be considered the pioneer of Rome, Francesco Speziale at Policlinic of La Sapienza of abdominal aorta surgery in Italy. University of Rome, and the undersigned at the University of Aquila, that initiated our careers as vascular surgeons Professor Fiorani was certainly one of the fathers of under his energetic impetus shall always remember his Italian vascular surgery he represented its values in Europe wisdom, his daily efforts to better himself, his scientific and the world, setting up constructive exchanges with major curiosity and his brilliant insights, gifts that made him a true representatives of the sector like Courbier and Kieffer in Maestro. France, Balas in Greece, Vollmar in Germany, Greenhalgh But in this circumstance, I cannot but recall the in England and Imparato, Wiley and Veith in the USA, with human side of Prof. Fiorani: he loved life and conviviality whom he contributed to the notable development of Open and demonstrated this by opening his house for numerous Vascular Surgery. post-congress dinners, with the constant support of his wife In the 1990s, when both surgical and endovascular Paola, with whom he had made a splendid family with five mini-invasive techniques were introduced, he immediately children. understood the importance of such techniques, recognising We were linked by being fans of Rome F.C. and he their positive impact in clinical practice and in research. was also a great sportsman: he loved skiing, the sea and sailing, was good at tennis and a fine golfer, a sport in which In fact, in the Vascular Surgery Unit of the 2nd there are stories of tough matches with his great friend Department of Surgery of La Sapienza University in Rome Raimondo Pistolese. an aortic endoprothesis was implanted (one of the first in Italy) with the assistance of its Argentine inventor Prof. Now he has passed away, but I believe that Professor Parodi. Fiorani shall be greatly missed by the entire Italian and international scientific and academic world. With his experience and under his guidance the Roman School of Vascular Surgery[ii] (Fig. 2) formed and Prof. Carlo Spartera he also actively participated in the foundation of the Italian Emeritus Professor of Vascular Surgery. Society of Vascular Surgery. Univerisity of L'Aquila, Italy

He was the first Italian to be President of the European Society of Vascular Surgery, and was also recognised and

Endnotes [i] Mi fa piacere aggiungere al ricordo del Prof. Fiorani la terapia delle patologie vascolari, arteriose e venose. Naturalmente, foto del frontespizio di un libro edito alla fine degli anni '80. E' una da quegli anni la chirurgia vascolare ha fatto passi da giganti pubblicazione di circa 500 pagine, con schemi anatomici, foto di esami nella modernizzazione dell'approccio e della soluzione di molte diagnostici e documentazioni intraoperatorie indirizzata agli studenti problematiche che allora sembravano insormontabili. Tuttavia, credo e agli specializzandi in chirurgia vascolare, edito da Delfino, allora che il libro possa essere ancora molto utile a chi affronta, per la prima all'avanguardia nell'editoria medico-scientifica. Il volume rappresenta, volta, tale settore scientifico-disciplinare. almeno in parte, ciò che ha significato, per gli autori, vivere la nascita, la giovinezza e la maturità della chirurgia vascolare italiana. Infatti, [ii] I am pleased to add this photograph of the cover of a book il volume racchiude l'esperienza di 20 anni del gruppo di chirurgia published at the end of the 1980s to the commemoration of Prof. Fiorani. vascolare romano vissuta sul campo ed affronta i diversi aspetti It is a publication of about 500 pages, with anatomical diagrams, della fisiologia e fisiopatologia della clinica, della diagnostica e della photos of diagnostic exams and intraoperative documentation aimed

Vasculab Journal of Theoretical and Applied Vascular Research (page 45) - JTAVR 2018;3(1) Memorial pages at students and at doctors specialising in vascular surgery, published diagnostics and therapy of arterial and venous vascular pathologies. by Delfino, then in the avant-garde of the medical-scientific press. At Naturally, since that time vascular surgery has made giant steps in the least in part, the volume shows what it meant, for the authors, to live modernisation of the approach and the solution of many problems that through the birth, growth and maturity of Italian vascular surgery. In then seemed insurmountable. However, I believe that the book may still fact, the volume captures the 20-year experience in the field of the be very useful to anyone approaching this scientific-disciplinary sector Roman vascular surgery group and deals with the different aspects for the first time. of the physiology and physiopathology of the clinical presentation,

Vasculab Journal of Theoretical and Applied Vascular Research (page 46) - JTAVR 2018;3(1) Congress reports

Congress reports

© 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

In October and November 2018 two important plenary sessions, round tables and master classes on several scientific events were organized in the "new world", China topics of rehabilitation. and Russia. Both were very big congresses, able to testify the In the Beijing congress there were 350 speakers great potential of these countries (Russia, China and other and more than 3000 delegates, working for 39 sessions Asian emerging countries), which are becoming more and and simultaneously in 9 halls. In the Ulyanosk congress more important actors in the world of vascular events. instead more than 2000 delegates attended to the event, with

1 Director, Vascular Center, Nuova Villa Claudia, Rome, XXVIII World Congress of the Italy International Union of submitted: Nov 19, 2018, accepted: Nov 19, 2018, EPub Ahead of Print: Dec 19, 2018, published: Jul 7, 2019 Conflict of interest: none

October 18-21, 2018, Beijing, China DOI: 10.24019/jtavr.55 - Corresponding author: Prof. Pier Luigi Antignani, [email protected] 1 PL Antignani © 2018 Fondazione Vasculab impresa sociale ONLUS. All rights reserved.

The XXVIII world congress of International Union of University, who defined this event "a vascular meeting Angiology was held in Beijing from 18th to 21th of October without borders". 2018. Whole spectrum of vascular sciences and practices This event was held in conjunction with the 14th was discussed and presented from the distinguished faculty Chinese Capital Vascular Symposium (CCVS), which is of international and Chinese experts: an update on the recognized as one of the most influential congresses of use of conventional and newer anticoagulants in vascular vascular surgery in China and brings together vascular medicine and surgery, development of treatment of lower surgeons, interventionists and diabetic foot specialists. extremity peripheral arterial diseases, recent advances in the management of acute ischemic stroke, aortic dissection, The conference was organized by Prof. Yong-quan microcirculation in vascular skin changes, vasculitis, Gu, Chief of Department of Vascular Surgery of the Beijing

Vasculab Journal of Theoretical and Applied Vascular Research (page 47) - JTAVR 2018;3(1) Congress reports advances in antiplatelet drugs, news in endovascular A lot of space was dedicated to Nursing and treatment of aortic diseases, conceptual approach to technicians. the venous malformation management, development and challenge of carotid artery stenting for carotid artery This Congress was certainly a landmark in the stenosis, approach to reperfusion therapy for acute ischemic development of the International Union of Angiology and stroke: mechanical thrombectomy, clinical challenges the perfect illustration of its commitment as the "World in chronic venous diseases, vicious circle of chronic Vascular Forum". venous diseases pathophysiology, an update on the The organizing committee made a great scientific management of DVT and post thrombotic syndrome, meeting as well as a unique cultural and human experience: unusual arterial diseases, treatment for vena cava disease, a thorough scientific program with a distinguished faculty arterial and venous thrombolysis diagnosis and treatment, of international and Chinese experts, a convenient venue venous thromboembolism, treatment of non-thrombotic with all the needed facilities nearby the Olympic Stadium, iliac vein compression syndrome, EVAR complications, and of course the thoughtful Chinese hospitality. management of visceral arterial disease, Buerger’s disease, lymphatic malformation and lymphedema, translational The next congress will be organized in Rome under medicine, arterial science and innovation, vascular the Presidency of Prof. PL Antignani, President elect of ultrasound, diabetic foot, stem cells and regenerative IUA. treatments, exercise in assessment and treatment of vascular diseases, wound repair. Prof. Pierluigi Antignani President elect International Union of Angiology (IUA)

The Organizing Committee of the XXVIII IUA Meeting You are invited to join the XXIX IUA Meeting in Rome.

1 All-Russian scientific-practical The Ulyanovsk State University, Ulyanovsk, Russia 2 conference with international The Research Centre of Neurology, Moscow, Russia participation. Nexus Medicus 2018: submitted: Nov 19, 2018, accepted: Nov 19, 2018, EPub Ahead of Print: Dec 19, 2018, published: Jul 7, 2019 Modern approaches to rehabilitation Conflict of interest: none

DOI: 10.24019/jtavr.56 - Corresponding author: Prof. Nov 9-10, 2018, Ulyanovsk, Russia Liudmila Belova, [email protected]

© 2018 Fondazione Vasculab impresa sociale ONLUS. 1 1 2 1 L Belova , V Mashin , N Belova , N Ilina All rights reserved.

All-Russian scientific-practical conference with approaches to rehabilitation” was held in Ulyanovsk on international participation “Nexus Medicus 2018: Modern November 9-10, 2018. Over 1,211 medical specialists and

Vasculab Journal of Theoretical and Applied Vascular Research (page 48) - JTAVR 2018;3(1) Congress reports

512 young scientists from different cities of Russia took part in the event. Talks by leading scientists from Russia, Italy, Uzbekistan, United States were given.

The conference was organized by the Ulyanovsk State University, Union of Rehabilitologists of Russia, National Training Foundation, Federal Agency for Youth Affairs, Ministry of Health of the Ulyanovsk Region, Research Center of Neurology, Association of Clinical Phlebologists of the Ulyanovsk Region.

«Nexus Medicus» has been held since 2013 and gathers in Ulyanovsk scientists and doctors of various specialties from Russia, Italy, USA, Brazil, Argentina, Israel, to discuss issues of medicine. This year, the main topics of the conference were prospects for the development of medical rehabilitation in Russia and abroad, high-tech Opening the conference, the Chairman of the means of rehabilitation. Government of the Ulyanovsk Region Alexander Smekalin noted that the discussion within the framework of Nexus Medicus of the issues of returning the affected economic independence and social usefulness is extremely important. It is full-fledged rehabilitation that contributes to reducing the number of people with disabilities and increasing the duration of the quality of life of the population.

Professor Boris Kostishko, the rector of the Ulyanovsk State University, welcomed the participants. He told about the history of “Nexus Medicus”, that in five years the project has turned into a large-scale movement, consolidating the ideas of talented scientists from around the world. “It is particularly encouraging that students who have the opportunity to contribute to the development of the best practices of modern medicine participate in this movement on an equal footing with recognized scientists,” Agreement between the University of Ulyanovsk, said Boris Kostishko. represented by the Chancellor, Prof Boris Kostishko and the Chief Specialist in Medical Rahabilitation of the Professor Galina Ivanova, Chief Specialist in Medical Russian Federation, Prof Galina Ivanova. Rehabilitation at the Ministry of Public Health of the Russian Federation, emphasized: “The purpose of such conferences is to build a medical rehabilitation system so that our citizens receive the maximum help based on the capabilities of national health care. Medical rehabilitation is a mandatory part of the provision of medical care to patients in any profile. A complete chain of care should work not only when the patient was rescued from death and operated on, but also to provide him with a high quality of life. This is not only rehabilitation, but also palliative care”.

According to Sergey Panchenko, Minister of Health of the Ulyanovsk Region, “Nexus Medicus” attracts specialists from all over the world. “The subject matter of the conference is extremely relevant - rehabilitation helps to bring to life people with severe illness and received very active, sometimes even aggressive treatment. It is very Youth session on “Building a socially significant project in important to conduct this work based on the best federal and the field of rehabilitation”. international level.”

Vasculab Journal of Theoretical and Applied Vascular Research (page 49) - JTAVR 2018;3(1) Congress reports

One of the brightest impressions of the conference of an algorithm for rehabilitation measures for each group was the presentation by Pier Luigi Antignani, Professor, of patients, taking into account the severity of venous Director of the Vascular Center Nuova Villa Claudia, insufficiency, age, physical activity, associated diseases, Honorary President of the Italian Society for Vascular mental health. Investigation, President Elect of International Union of Angiology, with the reports: “The Consensus of the The conference participants had the opportunity International Union of Phlebologists for the Rehabilitation to attend the round table “Principles of organizing of Patients with Chronic Venous Diseases of the Lower rehabilitation help in Russia” and “Training specialists for Limbs” and “Consensus of the International Union of a multidisciplinary rehabilitation team”, a master class on Phlebologists on Congestive Pelvic Syndrome: what's new “Positioning patients with focal brain lesions”, a youth in treatment and rehabilitation?” and the master class session “Forming a socially significant project in the field “Ultrasound examination in chronic venous insufficiency of of rehabilitation”, a poster session, a volunteer session. the lower limbs.” The exhibition demonstrated to doctors modern medicines, physiotherapeutic devices and balneological Doctors of various specialties dealing with the equipment, advanced technical means of diagnostics and problems of venous pathology once again discussed the rehabilitation, auxiliary means for rehabilitation and care. need for a systematic approach to patients with venous disorders and an individual approach to the development L Belova, V Mashin, N Belova, N Ilina

Vasculab Journal of Theoretical and Applied Vascular Research (page 50) - JTAVR 2018;3(1)

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Vasculab Journal of Theoretical and Applied Vascular Research (page 53) - JTAVR 2018;3(1) Table of contents

Journal of Theoretical and Applied Vascular Research The Official Journal of the Vasculab Foundation

Volume 3 Feb 2018 Issue 1

Editorial Board ...... 3

Editorial Lines ...... 5

Vascular News ...... 7 INSTRUCTIONS TO AUTHORS ...... 9

The great and silent revolution of the units of measure F Passariello ...... 11

Animal welfare in Italy from unification to the XXI century: a recent book on the subject F Morganti ...... 15

Beninese therapeutic pluralism. Historical roots and bioethical issues A Maccaro ...... 19

Evaluation of an accelerometer-based device to monitor compliance on patients wearing medical compression stockings E Grenier, D Rastel, C Chaigneau ...... 25

The tenacious tendency to saphenous reflux recurrence and the possibility how to counteract it C Recek ...... 33

Occlusion of the popliteal artery after focused ultrasound treatment - a case report FP Faccini, JMC Souza, AL Arendt ...... 37

Memorial pages ...... 41 In memory of Prof. Claude Gillot JF Uhl Professor Paolo Fiorani: “Maestro” of a generation of vascular surgeons C Spartera Congress reports ...... 47 XXVIII World Congress of the International Union of Angiology PL Antignani All-Russian scientific-practical conference with international participation. Nexus Medicus 2018: Modern approaches to rehabilitation L Belova, V Mashin, N Belova, N Ilina Table of contents ...... 54

Vasculab Journal of Theoretical and Applied Vascular Research (page 54) - JTAVR 2018;3(1)