UNLOCK EP LAB CAPACITY WITH MEDTRONIC CRYOBALLOON TREAT MORE PATIENTS. SAVE TIME. REDUCE STRESS.

University Clinical Centre Rijeka, Croatia ABLATION AS A TREATMENT FOR AF

The 2016 European Society of (ESC) serious bleeding, or cardiac arrest, or on all-cause guidelines recommend PVI with ablation, mortality. However, a per-protocol analysis censoring without further substrate modification, as first- the 9.2% of ablation patients who did not get line therapy to treat patients with AF. Catheter the procedure and the 27.5% of the drug group ablation can be performed with radiofrequency (RF) who crossed over to ablation shows substantial or cryothermal energy.5 An alternative to catheter advantages to the ablation procedure: 33% relative ablation is antiarrhythmic drug therapy. reduction in the primary composite endpoint, and Results from CABANA, a large multicentre, 40% relative reduction in all-cause mortality. Both randomised controlled trial comparing catheter analyses showed a significant 17% relative reduction ablation to drug therapy for the treatment of AF, in death or cardiovascular hospitalisation associated did not demonstrate a significant difference in the with .6 primary composite endpoint of disabling stroke,

ATRIAL FIBRILLATION: CRYOBALLOON ABLATION THE CURRENT EPIDEMIC ECONOMIC VALUE

Atrial fibrillation (AF) is the most common sustained FIRE AND ICE,10 the largest multicentre, prospective, operator and volume-dependent. Cryoballoon cardiac arrhythmia, affecting 1–2% of the general randomised trial that compared the efficacy and ablation results were more consistent regardless population around the world.1,2 In Europe, there are safety of Cryoballoon ablation and RF ablation, of centre or operator experience. As a result, the over six million people diagnosed with AF,3 although met its primary safety and efficacy endpoints outcomes in less experienced centres favoured the actual number is estimated to be much higher with shorter, more consistent procedure times. , reflecting its shorter learning curve and since so many cases remain undiagnosed. With the Secondary analyses results highlight clinically greater reproducibility.8 A single-centre study also ageing population and increasing life expectancy meaningful outcomes that are highly impactful demonstrated that RF ablation procedure durations across Europe, it is estimated that there will be to patients. Relative to RF ablation, Cryoballoon are more variable than Cryoballoon ablations. In 14-17 million people with AF in Europe by 2030.4 ablation demonstrated 21% fewer all-cause absolute terms, 28.6% of RF procedures proved to This is based on the fact that the prevalence of AF hospitalisations, 34% fewer cardiovascular be more than 30 minutes longer than the median increases with age, from 0.5% at 40–50 years of age hospitalisations (including AF hospitalisations), 50% duration, while for Cryoballoon ablation procedures, to 5–15% at 80 years of age. Given the comparable fewer direct current and 33% fewer only 4.4% of procedures exceeded the median by demographic landscape in Croatia and the repeat ablations.7 over 30 minutes. Since a procedure with increased assumption that the prevalence of AF is similar to that Studies also demonstrate that Cryoballoon ablation variability can lead to less efficient resource planning of the rest of Europe, it is estimated that there are procedures are more reproducible and have more related to cath lab space and staffing, it can be currently 40–50 thousand patients with AF in Croatia.5 consistent outcomes compared to RF. presumed that procedure duration variability results in more resource requirements and therefore, higher Today, there are seven centres in Croatia treating For instance, a French prospective multicentre costs. Cryoballoon ablation can thus be considered atrial fibrillation patients with pulmonary vein isolation survey comparing the safety and efficacy of more resource efficient than RF ablation.9 (PVI) via catheter ablation. In 2017, there were 778 AF Cryoballoon and RF ablation demonstrated ablations performed in Croatia, 23% of which were that both techniques resulted in similar rates of performed with Cryoballoon ablation and 77% with freedom from AF (68–80% at 18 months), although point-by-point radiofrequency (RF) ablation. the Cryoballoon procedure outcomes were less CATH LAB MANAGEMENT AT UNIVERSITY CLINICAL CENTRE RIJEKA

EP RESOURCES changes to the schedule can be addressed in time. To improve pathway and workflow efficiency, The cardiology department at University Clinical Knowing the schedule in advance also gives teams effective communication among ward personnel Centre (UCC) Rijeka is comprised of two cath labs, enough time to perform any additional tests required is very important. For instance, it can significantly one of which is also an EP lab. The EP team at UCC for patients undergoing AF ablation before their reduce patient changeover time and reduce idle Rijeka consists of three nurses, one scheduled procedure to avoid any unnecessary time in the cath lab when the next patient is brought technician, one experienced EP specialist who is complications or delays. from the ward to the preparation room next to performing AF ablations, and two EP fellows who the cath lab where final preparations are made, at are still in training. Together, this team performs THE PATIENT PATHWAY the final stage of the preceding patient. Patient diagnostic coronarography, PCI, endovascular valve The patient admission protocol is as follows: turnover efficiency is also supported by the fact that implantation or repair, EVAR, TEVAR, LA appendage Cryoballoon ablation procedures are performed with Physical examination occlusion, device implantation and extraction, analgosedation, rather than general anesthesia. and catheter ablation procedures. ECG Given the diversity of the procedures performed and Routine blood tests the department resource constraints, it is essential Blood coagulation tests that procedures are managed efficiently and Blood type (in case of complications requiring according to a strict schedule. urgent blood transfusion)  Transesophageal THE GROWING DEMAND FOR AF ABLATIONS Adequate preprocedural anticoagulation The EP team at UCC Rijeka started performing therapy planning AF ablations two and a half years ago. To support access to AF ablations for the increasing number of people with AF, the hospital team hosts educational events for general practitioners and cardiologists Given this context, it is extremely important to about AF ablation therapy and the types of patients manage EP procedures efficiently and to thoughtfully who are indicated for the treatment. With growing plan the procedure schedule in advance and in THE CRYOBALLOON ABLATION awareness of the AF ablation outcomes in the local detail. Any changes in procedure durations affect medical community, and as word of mouth from the schedule, which can then cause increased idle LEARNING CURVE patients spreads, more and more patients are being time, longer cath lab occupancy time per procedure, referred to UCC Rijeka for AF ablations every year. or the need to postpone or cancel procedures The first AF ablation at UCC Rijeka was performed on To meet the growing demand for AF ablations, UCC altogether. Therefore, in addition to the need for a the 11th of April 2016 using Cryoballoon and since Rijeka has been steadily increasing the number of procedure that is effective, with a low complication then, 167 AF ablations have been performed with AF ablation procedures performed per year. The EP and repeat ablation rate, it is also very important for either cryoablation or point-by-point RF ablation. team performed 35 AF ablation procedures the first the selected method to have a predictable procedure Although both technologies are used at the hospital, year, 75 the second year, and this year the EP team duration. This helps to ensure optimal utilisation the learning curve was different for each technology. plans to perform 120 AF ablations using either RF or of hospital resources and prevents unforeseen New operators at UCC Rijeka began performing Cryoballoon ablation technologies. overtime hours for staff. To optimise cath lab time Cryoablation procedures independently after only and reduce operator idle time, block scheduling is two proctorship sessions. The straightforwardness EFFICIENT PROCEDURE MANAGEMENT used by the arrhythmologic team. Four days per of the Cryoballoon ablation procedure together Scheduling constraints coupled with the increasing week, one cath lab is reserved for the arrhythmologic with the fact that the safety of the patient was not demand for AF ablation makes it very important to team performing catheter ablation or device-related compromised even in the early learning phase helped have a simple and predictable AF ablation approach procedures. Usually two days are reserved for to save time, reduce costs, and enable an efficient to avoid long waiting lists and unplanned overtime for catheter ablation and the other two days for device- adoption process. This is supported by findings staff. Cost effectiveness is also critical in managing related procedures. Depending on the waiting list from a single-centre study in which new operators such an increase in procedures, since resources are and resource availability, both catheter ablations were able to perform PVIs successfully and with divided between several different teams and fields of and device-related procedures can be performed on short procedure and durations after endovascular procedures. the same day. By planning ahead, any unexpected performing 20-30 procedures.10 PERFORMING EIGHT PROCEDURES THE FOLLOWING PROTOCOL IS IMPLEMENTED FOR CRYOBALLOON ABLATION PROCEDURES: 1  Two nurses work together to prepare the procedure material before each case. IN ONE LAB IN ONE DAY 2 The patient is prepared for the procedure by the ward nurses in a room next to the EP lab toward the end of the previous procedure. This is done while the EP nurses prepare the procedure material to Despite limitations including limited available cath optimise EP lab time per procedure. lab time and a lack of staff, the arrhythmology team 3 Once the material is prepared, the patient is brought into the EP lab and the nurse administers the initiated a project of performing four AF ablations analgosedation in predetermined doses. and four complex device-related procedures in one 4 The procedure is usually started by an EP fellow, with procedure support from the radiology cath lab in a single day. technician and an EP specialist present at the bedside. The EP nurse is at the EP recording station The planning process was extremely important, as while another nurse assists with the procedure, as needed. Once the initial procedure steps are the team needed to ensure that the procedures were complete, the EP specialist proceeds with the more complex procedure steps, while the EP fellow assists him at the bedside. completed in a limited time frame with the same 5  When the Cryoballoon is inserted, the radiology technician leaves the bedside and works at the EP level of efficacy and safety for the patients. This station while an EP nurse operates the CryoConsole. It is important to stress out that our nurses and included detailed planning of the patient preparation radiology technician are both educated in every step of the procedure and can share duties. process, respecting standardised procedure steps, 6   A nurse in the EP lab informs the ward nurse who is with the next patient to begin preparing the patient and carefully coordinating patient turnover post- for the next procedure during the final steps of the ongoing procedure (catheter removal). procedure. It was also very important to know the 7  The groin puncture site is closed with a figure-of-eight suture. expected duration and cath lab occupation time 8  A transthoracic echocardiogram (TTE) is performed to exclude pericardial effusion. for each procedure in order to minimize possible an increase in patient turnover and lab occupancy 9 The patient is then transferred to the ward where he or she is continuously monitored by a central setbacks and procedure duration variations. time. This made performing eight different, complex monitoring system for the next eight hours and regularly checked by nurses and physicians. Because of the simplicity and the short, predictable procedures in a limited time frame possible. procedure duration and lab occupation time, Because of the effective team communication and cryoablation was the method chosen for AF ablation. strict adherence to procedure protocols, the team For both ablation methods, the same medications The duration of hospitalisation for patients The simple setup of the CryoConsole™, and the successfully performed four cryoablations, two are used with the same starting doses: 1 mg of undergoing AF ablation in UCC Rijeka is 2-3 days fact that cryoablation does not require a complex complex device extraction procedures with general Midazolam and 100 µg of fentanyl. 70% of patients with the duration varying slightly depending on mapping system, made it possible to switch between anaesthesia, and two high power device implantation the type of fibrillation. The hospitalisation time is undergoing cryoablation required and additional AF ablations and device-related procedures without procedures in one cath lab. usually slightly longer for patients with persistent dose of 100 µg of fentanyl, while every patient and longstanding persistent atrial fibrillation due to undergoing RF ablation required additional doses the higher incidence of AF recurrence and therefore with a cumulative additional dose varying from 100 sometimes the need for and additional to 500 µg of fentanyl. antiarrhythmic drug assessment. THE AF ABLATION WORKFLOW AT UCC RIJEKA OPTIMISING LAB OCCUPANCY TIME the mapping system. On the other hand, the set-up CONCLUSION At UCC Rijeka, Cryoablation procedures are managed for Cryoballoon ablation is much simpler and can efficiently, with a protocol that seeks to reduce be easily performed before or after different types of procedures without significant patient turnover or eliminate potential idle time in the cath lab. UCC Rijeka has been performing AF ablation Rijeka, AF ablation using Cryoballoon has proven to prolongation, which is extremely important for the The average time from the point when the patient procedures with both point-by-point RF ablation be a relatively simple procedure with a short learning hybrid cath lab. enters the EP lab, until the procedure begins with and Cryoballoon ablation for the past two and a curve. With thoughtful planning, efficient patient the injection of local anaesthetics, is 28 minutes half years. With limited resources available for preparation and operational protocols, a significant for cryoablation and 42 minutes for RF ablation. CRYOBALLOON ABLATION PROTOCOL catheter ablation and an increased demand for number of procedures can be performed, even in a The variation in duration between the two approaches The average procedure time for cryoablation was 82 the procedure, the arrhythmology team is facing context with resource and time limitations. With only is largely due to the time needed to set up the 3D minutes, with the shortest procedure time being 57, mapping system used for RF ablation. Due to the and the longest 105 minutes. The average RF ablation many challenges, which they can help to address four days per week when the cath lab is available, complex setup required for the 3D mapping system, it procedure time was 121 minutes, with a shortest with precise planning, efficient cath lab utilisation, the arrhythmology team performs approximately is very difficult and time consuming to switch between procedure time of 76 minutes, and a longest of 163 and procedure duration predictability. Cryoballoon 500 device implantations, 25-30 lead extraction procedures using the mapping system and those minutes. However, the average fluoroscopy time for ablation has proven to be an effective procedure procedures which are complex and time consuming, which are performed without it, forcing the EP team Cryoballoon ablation was 18 minute, while the average with a low complication rate, short preparation time and 250-300 catheter ablations, including AF to reserve days in the EP lab for procedures using fluoroscopy time for RF ablation was 9 minutes. and a short, predictable procedure duration. At UCC ablations, annually. REFERENCES

1. Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic 7. Kuck et al. Cryoballoon or RF ablation for symptomatic PAF: features of chronic atrial fibrillation: the Framingham study. N reintervention, rehospitalisation, and QoL outcomes in the FIRE Engl J Med. 1982 Apr 29;306(17):1018–1022. AND ICE trial. Eur J. 2016 Oct 7;37(38):2858-2865. Epub 2016 Jul 5. 2. S Stewart et. Al. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov; 8. Providencia Rui et al. Results from a multicentre comparison of 86(5): 516–521. cryoballoon vs. RF ablation for paroxysmal AF: is cryoablation more reproducible? Europace 2017 Jan;19(1):48-57. 3. Pillarisetti J, Lakkireddy D. Atrial fibrillation in Europe: state of the state in disease management! European Heart Journal, Volume 9. Monnickendam, Asmundis Why the distribution matters: Using 35, Issue 47, 14 December 2014, Pages 3326–3327. discrete event simulation to demonstrate the impact of the distribution of procedure times on hospital operating room 4. Baker, C. House of Commons Library Briefing Paper. NHS Hey utilisation and average procedure cost; Operations Research for Statistics: England, May 2018. Number 7281, 21 May 2018. Health Care 16 (2018) 20–28. 5. Manola S, Pavlovic N. Ablation of atrial fibrillation in the Republic 10 Velagić V, et al, Learning curve using the second-generation of Croatia. Cardiologia Croatica 2016;11(5-6):161. Cryoballoon ablation. Italian Federation of Cardiology 2016. 6. Packer D et al. Catheter Ablation vs Antiarrhythmic Drug Therapy in Atrial Fibriallation (CABANA) Trial. Heart Rhythm Society presentation, 2018.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative or consult the Medtronic website at www.medtronic.com.

Europe Medtronic International Trading Sàrl. Route du Molliau 31 Case postale CH-1131 Tolochenaz UC201908498EE ©2019 Medtronic. Tel: +41 (0)21 802 70 00 All rights reserved. Fax: +41 (0)21 802 79 00 Printed in Europe. www.medtronic.eu