2020 SVS VQI Annual Report

2020 Detailed Annual Report

1. Executive Summary: The Value of Participation in the SVS VQI 1 2. Impact of COVID-19 3 3. SVS VQI Members Profile 4 4. Outcomes and Data Quality Dashboards 5 5. Regional Quality Groups 7 6. MyPAD Pilot 8 7. Quality Improvement Methods: Learning from the Data 9 8. SVS VQI National QI Projects 10 9. SVS VQI Data Analysis 12 10. SVS Guidelines and the SVS VQI 13 11. SVS PSO Surveillance of Paclitaxel Mortality 13 12. Using SVS VQI Data for Collaborative Projects 15 13. The SVS VQI and Compliance with EUMDR 17 14. Future Developments 17 13. The SVS VQI and Compliance with EUMDR 17 14. Future Developments 17

APPENDICES

A. Participating Sites 19 B. SVS Patient Safety Organization Structure 23 C. Medstreaming/M2S Technology Partner 23

SVS VQI 2020 Annual Report 1. EXECUTIVE SUMMARY - THE VALUE OF PARTICIPATION IN THE SVS VASCULAR QUALITY INITIATIVE (SVS VQI)

Our mission is to gather data to help hospitals and physicians provide better vascular care by learning about their own performance.

Although the past year has been dramatically Association (AHA), Society of Interventional impacted by COVID-19, the Society for Vascular Radiology (SIR), Society for Vascular Medicine Surgery’s VQI (SVS VQI) has had another very (SVM), Vascular Access Society of the Americas productive year. SVS VQI’s 14 registries contain (VASA), Society for Vascular Ultrasound (SVU), demographic, clinical, procedural and outcomes governmental regulatory agencies, device data from more than 750,000 vascular procedures manufacturers, and payers. The Registry performed nationwide and in Canada, with Assessment of Peripheral Interventional Devices the addition of Puerto Rico and Singapore this (RAPID) is a public/private partnership which year. Each record includes information from the uses the strength of different societies (SVS VQI, patient’s initial treatment and one-year follow-up. NCDR, and SIR) and their registries to enhance The wealth of data in the registry allows centers device evaluation and to develop objective and providers to be aware of their performance performance criteria for the endovascular and comparison to regional and national treatment of lower-extremity arterial occlusive benchmarks. disease. SVS VQI also works with industry to provide clinically detailed data for device Each center receives biannual dashboards and performance, post-market surveillance, and regular performance reports to allow them to label expansion. SVS VQI has partnered with do meaningful quality assurance and focus vascular registries from Europe and Asia to form their quality improvement initiatives. Biannual the International Consortium of Vascular Registries regional meetings allow physicians, nurses, data (ICVR) to bring a global perspective to improving managers, quality officers, and others to meet, vascular care and device evaluation. share information and ideas, and learn from each other in a positive and supportive environment. Members have used SVS VQI data to significantly improve the delivery of vascular care at a 103 local and national level thereby reducing new centers complications and expenses. 715 total centers Investigators have used SVS VQI data for risk stratification, outcomes analysis, quality 750,153 improvement, defining best clinical practices, procedures comparative effectiveness research and reducing resource utilization. This work has resulted in more 190 than 345 scientific publications in peer-reviewed new data analysis projects journals since 2011. SVS VQI membership also facilitates participation in clinical trials and other medical device evaluation projects. new120 published journal articles This year we are pleased to announce that the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) 18 Peripheral Vascular Intervention (PVI) Registry new quality is being merged with our SVS VQI registries effective January 2021. The SVS VQI collaborates improvement with multiple other organizations, including the abstracts and American Venous Forum (AVF), American Heart posters 1

www.VQI.org Activities for 2019/2020: INTRODUCTION TO THE SVS VQI 1. Center and procedure growth. As of September 2020, SVS VQI had reached two new milestones, with over 700 The SVS VQI is a collaboration of the Society for member centers and more than 750,000 vascular proce- Vascular Surgery Patient Safety Organization dures in its registries. (SVS PSO), 18 regional quality improvement 2. Projects and journal articles. In the past year, Society groups organized under the SVS PSO, and for Vascular Surgery Patient Safety Organization’s (SVS PSO) Medstreaming/M2S, its commercial technology Research Advisory Council approved 190 data-analysis proj- partner. The SVS PSO now has two new ects using SVS VQI data, and 120 articles based on SVS VQI partnerships – one with the ACC to merge data were published in peer reviewed journals. the NCDR PVI registry into the SVS VQI and 3. National Quality Improvement initiatives. The SVS PSO one to partner with the AHA and SVM for continues work on two major quality initiatives, working with the continued development of the Vascular regional quality groups and centers to develop strategies Medicine Consult Registry. Other partners to 1) increase the prescription of Antiplatelet agents and include the AVF, SVM, SIR, VASA and SVU, Statin medications at discharge for secondary prevention following a vascular operation and 2) increase the imaging along with an additional 16 endorsing societies of AAA sac diameter for long-term follow-up of patients who (see Appendix C for the full list). The mission have undergone Endovascular AAA repair. of SVS VQI is to improve the quality, safety, effectiveness and cost of vascular healthcare. 4. SVS VQI Best Practices Dashboards. Center-level dash- board reports are produced quarterly for each SVS VQI registry to report outcomes and provide benchmarks. The SVS PSO is a wholly-owned subsidiary of the Society for Vascular Surgery, with headquarters 5. While the VQI@VAM had to move to a new, online format in Chicago. The SVS PSO governs all functions on short notice, the VQI ONLINE remote event was clearly of SVS VQI, including the specification of a success - with attendance at record levels. We pre- data elements captured in each registry, the sented the latest quality activities, including in-depth case reviews, case study presentations, and outcomes analysis standard reports made available to regional as well as presentations from quality experts. In addition, groups, member hospitals and physicians, and the presentations were used to create an online reference SVS VQI national quality improvement projects. library that can be used as a resource in the future. This library can be accessed for onboarding new sites and in- The SVS PSO is supported by over 250 physician depth learning by current participants. volunteers who dedicate their time and effort 6. Industry projects. Several post-approval surveillance in support of SVS VQI mission. These physicians projects are currently underway in SVS VQI. In addition, the provide governance, clinical support to all Transcarotid Surveillance Project (TSP) facilitates reimburse- the registries and data analyses and ad-hoc ment for centers wishing to perform TransCarotid Arterial support in areas such as industry partnerships Revascularization (TCAR). SVS VQI allows data collection for CREST-2 participation and works with industry and regulatory and communications. In addition, each center agencies in the Registry Assessment of Peripheral Interven- and region have lead physicians and regional tional Devices (RAPID) and Superficial Popliteal EvidEnce medical directors to provide guidance, identify Development (SPEED) projects. best practices and develop regional initiatives. 7. Development. The launch of the Venous Stent Registry and Vascular Medicine Consult Registries were major mile- The SVS PSO is funded by annual registry stones. We completed a major revision to the Hemodialysis subscription fees from participating hospitals or Access Registry (HDA) and minor revisions for EVAR, PVI, physician groups, and additional contributions INFRA and SUPRA and Varicose Vein Registries. In response for SVS VQI projects are provided by corporate to the pandemic, COVID-19 variables have been added to supporters. SVS VQI which will allow us to measure outcomes and the impact of the virus on vascular care in the future.

8. EUMDR. The new European MDR adds a new total product life-cycle approach to medical device regulation. SVS VQI has supplied data for a number of industry partners to help meet EUMDR requirements. Vascular9. SVS Guidelines. Quality Professional societies publish Initiative® clinical practice guidelines to provide evidence-based recommendations and to reduce practice variation and to improve care. A report on SVS VQI Assessment of SVS Clinical Practice Guidelines on AAA was published in the September 2020 issue of JVS. (https://pubmed.ncbi.nlm.nih. gov/31973949/).

2 SVS VQI 2020 Annual Report 2. IMPACT OF COVID-19 THE SVS VQI REGISTRIES The abrupt shutdown nationally of routine elective As of end of September 2019, there were 14 SVS vascular surgery procedures on March 15, 2020 fol- VQI registries that contained 635,345 vascular lowing the plea from US Surgeon General to help procedures. During the past year (October ‘Flatten the Curve’. As a result, vascular procedures 2019 through September 2020), there were over in the SVS VQI dropped 7-fold for arterial and 5-fold 114,000 procedures added to the registries, for for venous during mid-March to end of May in 2020 a total of 750,153 as of the end of September when compared to same period 2020. SVS VQI Data 2020. Manager Survey findings: 1) 90% of centers performed both emergent and urgent procedures during 6 weeks of shutdown 2) 40% of centers continued performing elective procedures during this time at normal or Total Procedures reduced rate 2) Three out of four DM’s were not fur- Captured as of 10/1/2020 750,153 loughed or re-assigned during this time 3) LTFU continued in 90% of centers by adapting to remote contact of patient and increased use of electronic record Peripheral Vascular Intervention 246,062 information over face to face (30%) contact. Carotid Endarterectomy 146,129

SVS VQI Physician Survey findings: 1) Restrictive OR Infra-Inguinal Bypass 63,699 policy crafted by institutional guidelines (61%), societal guidelines (51%) and federal recommendations from Endovascular AAA Repair 59,130 CDC/CMS (30%) 2) Restrictive OR policy was active Hemodialysis Access 59,036 with 74% of respondents yet one half continued to do non-emergent procedures deemed necessary for Carotid Artery Stent 46,737 disease presentation including dialysis access (48%), elective AAA (41%) and graft threat for PVI (61%) 3) Varicose Vein 41,129 SVS guidelines for AAA repair were not changed for Supra-Inguinal Bypass 20,783 52% of respondents while the rest adopted a larger size threshold for both male and female to repair. Thoracic & Complex EVAR 19,260

To monitor COVID-19 impact on SVS VQI over time, Lower Extremity Amputations 19,217 the SVS PSO has incorporated new variables to all of IVC Filter 14,812 the procedural registries as of September 2020: Open AAA Repair 14,147 • COVID-19 testing availability at time of procedure • COVID-19 symptoms at time of procedure Venous Stent 12 • Determination if COVID-19 delayed procedure or evaluation prior to procedure •Judgement by clinician if delay affected patient care adversely VQI Total Procedure Volume • For LTFU: If patient has experienced COVID-19 800,000 infection during interim and if symptomatic as a result of infection 700,000

600,000 The SVS/PSO has submitted two manuscripts to the JVS detailing the above findings above and discussing 500,000 the known and perceived impact on registry volumes. SVS VQI participation awards have been modified this 400,000 year (2020) to delete LTFU criteria as a component for 300,000 assessing center performance. 200,000

100,000

0 Jan-14 Jan-15 Jan-16 Jan-17 Jan-18 Jan-19 Jan-20 Sep-14 Sep-15 Sep-16 Sep-17 Sep-18 Sep-19 Sep-20 May-14 May-15 May-16 May-17 May-18 May-19 May-20

www.VQI.org 3. SVS VQI MEMBERS PROFILE

Center participation in SVS VQI continues with steady growth reaching over 700 centers including office-based laboratories by the end of September 2020 (Figure 3.1). There is a good distribution of types of participating sites representing different practice types – 28% academic institutions, 30% teaching hospitals and 42% community hospitals (Figure 3.2). There is also broad distribution of physician specialties – less than half vascular surgeons, 15% interventional cardiology, 15% interventional radiology, 7% general surgery, 5% cardiothoracic surgery and 4% neurosurgery (Figure 3.3).

Growth of VQI Centers

Source: M2S PATHWAYS Data, September 2020 Figure 3.1: Growth of SVS VQI Centers (YTD September 2020)

Source: M2S PATHWAYS data, April 2020 Source: M2S PATHWAYS Data, April 2020 Figure 3.2: SVS VQI Participating Hospital Types Figure 3.3: Distribution of SVS VQI Physician Specialties

4 SVS VQI 2020 Annual Report 4. OUTCOMES & DATA QUALITY DASHBOARDS

The SVS PSO Best Practice Dashboards allow centers to review their performance and compare to regional and national benchmarks. The SVS PSO registry committees select outcome measures to be reported in the dashboards, which are distributed quarterly to SVS VQI members. The dashboards provide each center their individual results, along with results for their region and SVS VQI overall. Results that are in the “top” 25th percentile are highlighted green and those in the bottom 25th percentile are highlighted red.

PVI CLAUDICATION

5 www.VQI.org 10

PVI CHRONIC LIMB THREATENING ISCHEMIA

SVS VQI has 18 regional quality groups based on geographic proximity (Figure 6.1). Regional quality group meetings are in importantͷǤ aspect of SVS VQI and a key component to successful quality improvement. Regional groups distinguish SVS

6 SVS VQI 2020 Annual Report 5. REGIONAL QUALITY GROUPS

SVS VQI has 18 regional quality groups based on geographic proximity (Figure 5.1). Regional quality group meetings are in important aspect of SVS VQI and a key component to successful quality improvement. Regional groups distinguish SVS VQI from almost all other registries. Each of the 18 groups hold biannual meetings that provide a forum for discussion on outcomes analysis and work on quality improvement.

Figure 5.1: SVS VQI Regional Group Map

During each region’s bi-annual meeting, data are reviewed and discussed by the members present. Many groups identify an area for improvement and launch region-wide efforts to improve care. Topics that have been addressed include:

•Recording of hemodynamic data (ABI/Toe Pressure) prior to peripheral vascular intervention •Measuring aneurysm sac diameter one year following EVAR and TEVAR •Increasing rates of IVC filter retrieval •Reducing LOS for CEA and EVAR Increasing LTFU rates •Increasing statin and antiplatelet prescriptions at discharge •In hospital Stroke/Death for CEA, TFEM CAS, and TCAR •Compliance with SVS EVAR sac size guidelines •Compliance with SVS Cell-saver guidelines

www.VQI.org 6. MYPAD PILOT POTENTIAL BENEFITS FROM VQI The SVS VQI has created My PAD, a pilot program for the collection of patient-reported outcomes FOR KEY STAKEHOLDERS (PRO) on patients undergoing endovascular treatment for peripheral arterial disease (PAD). For Patients •Improve care based on SVS VQI data and quality initiatives •Use benchmarks and best practices to reduce length of stay •Improve long-term care through emphasis on follow-up and secondary prevention The SVS VQI recognizes that traditional outcomes such as patency and reintervention may not fully For Physicians/Providers capture the quality of care or the experience of •Adopt best practices through SVS VQI data PAD patients. There is an important need to learn analysis and measure the patient’s perspective. •Improve care through quality initiatives and charters The My PAD pilot will include 20 SVS VQI •Improve patient selection using SVS VQI risk centers participating in the Peripheral Vascular assessment calculators Intervention Registry. The pilot will test center workflow and seeks to improve PRO collection in the least burdensome manner by leveraging For Hospitals and Quality Officers technology, such as smart phones and tablets. •Improve care by quality initiatives and The SVS VQI will enroll a variety of practice types projects ranging from university to community-based •Identify meaningful benchmarks for QA and practices in rural and urban settings. The pilot will QI efforts serve as a foundation for a future SVS VQI roll-out •Reduce expenses by addressing resource of PAD PRO collection. utilization and length of stay

Highlights For Policymakers •Better data to inform decision making on • Outpatient peripheral vascular interventions policy development (PVI) for claudication or chronic limb threatening ischemia •Monitor safety and efficacy using real world • Collect VascuQoL-6 and EuroQoL 5D-5L evidence (estimated completion time less than 10-15 •Work collaboratively with the SVS to minutes) develop quality measures • Collection at three time points: pre-procedure, one month and one year postoperatively For Payers • PRO data entry options include paper forms, •Adopt best practices to reduce computer, tablet and smart phone complications and expenses • Patient education materials to aid in collecting •Inform population health approaches data directly from the patient through use of comparative data • PRO feedback to participating physicians •Reduce expenses due to decreased length of stay and resource utilization

For Industry •Enhance efficiency for label expansion using registry data •Utilize registry-based trials for pre-market approval and post-market surveillance •High quality, large scale, real world data for evaluation of device performance

SVS VQI 2020 Annual Report 7. QUALITY IMPROVEMENT QUALITY IMPROVEMENT PROJECTS PROJECTS: LEARNING FROM 2019 is the 2nd the year of participating THE DATA centers submitting QI project charters. The charters include the two national The QI Community initiatives of D/C Medications and EVAR The SVS PSO is encouraging participating centers LTFU Imaging, as well as clinical and to submit quality improvement charters on documentation topics. Charter projects projects using SVS VQI data. This process has are listed below: helped the SVS PSO identify groups working on similar initiatives and facilitate collaboration and networking opportunities. All members PARTICIPATING are encouraged to join in focused group calls CENTERS whether or not they have a charter. Also, TOPICS members who have successfully completed QI projects participate and share their processes Discharge Medications 5 and keys to success. As projects reach (National Initiative) completion, the SVS PSO will aggregate data LTFU (including EVAR Imaging, a 9 and share best practices with the full SVS VQI National Initiative), IVCF Retrieval membership. Clinical 2

The SVS PSO also provides resources to assist SVS Documentation 2 VQI centers with their QI projects: TOTAL 18 QI Project Guide and National Initiative Supplement: These booklets provide the foundation and step-by-step guidance to begin Table 7.1 – Quality Improvement Projects to Date and complete a QI project. The QI Project Guide is designed to assist centers beginning a QI project but may be useful at any stage of the QI process.

Subsequently, the SVS PSO created a National Initiative Supplement which focused on the progress with the two national QI priorities: Optimal Discharge Medications for Vascular Patients and Endovascular AAA Long-Term Follow-Up with Imaging. The “Members Only” area of the SVS VQI website (www.vqi.org) offers access to national QI materials, including presentations and videos, as well as a QI discussion forum to encourage interaction among centers. National and regional meetings and quarterly calls help SVS VQI data managers Jens Eldrup-Jorgensen, MD, SVS PSO Medical Director, share best practices and QI project ideas. pictured with Rosha Nodine from Baylor Scott & White, The Heart Hospital – Plano. Rosha was the 2019 QI Poster Winner at the VQI Annual Meeting.

9 www.VQI.org 8. NATIONAL QUALITY based information and tools for providers and patients, such as templated communications to IMPROVEMENT INITIATIVES— primary care physicians, to increase the number OPTIMAL DISCHARGE of patients receiving optimal medications. MEDICATIONS AND EVAR From January 2012 to the present, the LONG-TERM FOLLOW-UP prescription of antiplatelets and statins at discharge has risen steadily among SVS VQI IMAGING members (Figure 8.2) as information about its benefits was disseminated through presentation Experienced SVS VQI centers have applied registry data and implemented innovative of the data analysis, publication of the results and approaches to improve success rates for these sharing of reports with centers and physicians. initiatives. The SVS PSO seeks to build on these In addition to the original data analysis and efforts and help these QI initiatives expand publication led by Randall DeMartino, MD, the from clusters of innovation to coast-to-coast SVS PSO added webinars and presentations improvements. at the VQI Annual Meeting as part of this National QI Initiative. Individual QI charters and Optimal Discharge Medications for Vascular Patients The SVS PSO’s first national QI initiative was the prescribing of antiplatelet agents and statins at discharge to improve patients’ long-term vascular health. Discharge medications was selected because it is a treatment that affects Presentation VQI Reporting

VQI@VAM most vascular surgery patients and is readily Publication actionable. VQI@VAM DC Medications Webinar

SVS VQI data has shown that patients undergoing arterial procedures who received a discharge prescription of antiplatelet medications and a statin had significantly better 5-year survival (Figure 8.1). The SVS VQI provided physicians with individual reports showing SOURCE: SVSVQI their individual prescribing rates for discharge Figure 8.2: Discharge Medications and Statin Rate for 123 medications and how they compared to their SVS VQI Hospitals (2012 to Date) peers. The SVS VQI also disseminated evidence-

For example, one participating center used SVS VQI data to show that only 61% of their EVAR patients in 2016 received antiplatelet and statin medications at discharge following a vascular operation. They used a combination of clinical protocols, education and workforce reallocation to increase the rate to 81% in 2017 and 93% in 2018. The SVS PSO is now developing a program designed specifically to help centers with the greatest opportunity for improvement.

Figure 8.1: Five Year Survival after Vascular Surgery

SVS VQI 2020 Annual Report EVAR Sac Diameter Reporting The SVS VQI National Quality Initiative of EVAR Sac Diameter Reporting is in its 5th year. Since “Endovascular aortic aneurysm EVAR sac diameter is a long-term follow-up repair (EVAR) is a non-curative measure, rates are not calculated until two treatment of infrarenal years after the surgery date to allow centers adequate time to capture and enter these data. abdominal aortic aneurysm Historically, rates have held nearly constant at disease. When commercially 60%. The goal is for 100% of EVAR patients to have available devices are used imaging at one year. Increased compliance with EVAR sac diameter is associated with reduced within their instructions for use, risk of rupture and improved patient survival. excellent long-term rupture-free Many SVS VQI centers are beginning to identify survival can be anticipated. best practices and conduct studies on EVAR Sac However, due to the persistent Diameter Reporting, but an additional approach needs to take place to reach our goal. presence of the aneurysm and the life-long risk of device related failure and/or endoleak, up to 20% of patients may experience some form of aorta- related re-intervention after EVAR.

For this reason, EVAR Sac Diameter Reporting is mandatory, and patients need to be educated about this preoperatively and repeatedly during follow-up. It is the Figure 8.3: EVAR Sac Diameter Reporting obligation of the operating surgeon to stress the need for life-long surveillance and integrate discussions about LTFU into all stages of AAA EVAR care to ensure that their patients achieve durable outcomes.”

—Salvatore Scali, MD, Professor of Surgery, University of Florida

11 www.VQI.org 9. SVS VQI DATA ANALYSIS SVS VQI physicians may request de-identified datasets from each registry for analysis. The SVS PSO Research Advisory Council (RAC) reviews and evaluates requests for datasets by investigators, who provide the RAC a description of their proposed project. This year, the SVS PSO Executive Committee, the RAC and the Venous Quality Council agreed to create a new SVS PSO Venous RAC to facilitate the growth of venous data analyses and research, particularly in light of the new Venous Stent Registry.

In addition, SVS VQI has created the SVS VQI Figure 9.1: SVS VQI Approved Data Analysis Projects, February Vascular Implant Surveillance and Interventional 2011 to September 2020) Outcomes Network (VISION) which is a partnership between the SVS VQI and MDEpiNet that directly supports the mission of the SVS VQI to improve the quality, safety, effectiveness and cost of vascular healthcare by collecting and exchanging information. VISION links SVS VQI registry data to Medicare claims to generate novel registry-claims linked datasets. The datasets combine the clinical detail from the SVS VQI with long-term outcome variables derived from Medicare claims. VISION data is used to generate center-specific feedback reports called, Survival, Reintervention and Surveillance (SRS) and to analyze device performance and long-term outcomes of vascular surgical techniques. Use of the data is governed by Source: PubMed a Data Use Agreement (DUA) between Weill Figure 9.2, SVS VQI Publications, May 2012 to September 2020 Cornell Medical College and the Center for Medicaid and Medicare Services (CMS). VISION replaces the previous Medicare-Match data process. SVS VQI DATA ANALYSIS

The SVS VQI projects have improved clinical Visit VQI.org for everything you need to care by, for instance, developing practice request datasets, view approved projects, recommendations for the use of protamine and learn more about project charters arnd carotid patching from the Vascular Study Group processes., and more: of New England and for discharge medications from the SVS VQI database. As of the end of https://www.vqi.org/data-analysis/ September 2020, the RAC has approved 621 projects, and of those, 349 have been published in peer-reviewed journals (Figure 9.1 and 9.2). In the past year, 190 projects were approved and as of now, 120 have been published.

12 SVS VQI 2020 Annual Report 10. SVS GUIDELINES AND THE 11. SVS PSO SURVEILLANCE OF SVS VQI PACLITAXEL MORTALITY The SVS Document Oversight Committee Society for Vascular Surgery Patient Safety approached SVS VQI to see if the registries could Organization Surveillance of Paclitaxel Mortality be used to document compliance with SVS AAA in the Vascular Quality Initiative Authors: Daniel guidelines and help define impact on outcomes. Bertges, MD, Jens Eldrup-Jorgensen, MD, Fred Of the 111 SVS AAA guidelines, 10 could be Resnic, MD, et.al. measure in the SVS VQI OAAA and EVAR registries. Compliance with recommendations In December, 2018, a meta-analysis of was associated with improved outcomes randomized trials of paclitaxel devices for the and should be encouraged for providers. treatment of femoral-popliteal disease reported Participation in the SVS VQI registry provides higher 2 and 5 year mortality in patients treated an objective assessment of performance and with paclitaxel devices.1 These findings were compliance with guidelines. SVS VQI provider subsequently validated by an FDA analysis – and center reports may be used as a focus for a potentially concerning signal of increased quality improvement efforts. Vascular Quality long-term mortality in study subjects treated Initiative assessment of compliance with Society with paclitaxel-coated products compared for Vascular Surgery clinical practice guidelines to patients treated with uncoated devices on the care of patients with abdominal aortic prompting 3 letters of notification to providers. aneurysm was published in the September 2020 For further information please see the three issue of the JVS. prior FDA communications and the executive summary of the June 2019 Circulatory System A similar project is underway looking at the SVS Devices Panel Meeting.2-4 clinical practice guidelines on the treatment of claudication. Initial analysis shows that most In response to this mortality signal, the Society patients undergoing endovascular treatment for Vascular Surgery Patient Safety Organization for claudication are not compliant with has conducted surveillance of mortality in the “optimal medical therapy” defined as taking an Vascular Quality Initiative Peripheral Vascular antiplatelet agent and a statin as well as being Intervention registry. The analysis was conducted off tobacco products (Figure 10.1 ). in collaboration with Dr. Fred Resnic at the Lahey Clinic using Data Extraction and Longitudinal The SVS PSO in collaboration with the SVS Trend Analysis (DELTA), a risk adjusted software Guidelines Committee have been looking at application designed for signal detection in SVS VQI data related to the SVS Claudication clinical registries. Full details about the study are Guidelines in the PVI registry. 1A Guidelines state available at clinicaltrials.gov under the identifier that a patient should be on an Antiplatelet, NCT04110288. Statin, NOT smoking (Optimal Medical Therapy). This report summarizes the first results of our surveillance program. We compared paclitaxel drug coated balloons to plain balloon angioplasty and paclitaxel drug eluting stents to bare metal stents. At present, there is no mortality signal discernment in real world data using the VQI registry.

In an effort to provide VQI members with the most recent data, we plan to update the analysis on a biannual basis moving forward which will benefit from a larger sample size and longer follow-up.

References 1. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Figure 10.1 Optimal Medical Rx Compliance Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245 2. https://www.fda.gov/medical-devices/letters-health-care-providers/treatment- peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting-stents 3. https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment- peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting 4. https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019- update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel

www.VQI.org SVS PATIENT SAFETY ORGANIZATION, SOCIETY VMC Steering Committee. “This new registry FOR VASCULAR MEDICINE, AND AMERICAN will allow us to compare the full spectrum of HEART ASSOCIATION, LAUNCH NEW VASCULAR treatment options for patients with vascular MEDICINE CONSULT REGISTRY FOR SVS VQI disease in order to define the best treatment for each patient,” said DeMartino. Dr. Jaff The Society for Vascular Surgery Patient Safety noted that the new Registry enables physicians Organization® (SVS PSO) and the Society for to have a comprehensive view of a patients’ Vascular Medicine (SVM), in collaboration with medical profile. He explained, “We can see if the American Heart Association® (AHA), are we have done enough to keep them healthy. excited to introduce the Vascular Medicine We can understand in greater detail how Consult Registry (VMC Registry) for the SVS cardiovascular risk factors are managed and VQI. The Registry targets the management of how that impacts patient outcomes.” new patients who are being treated medically for Atherosclerotic Carotid Artery Occlusive Utilizing the M2S PATHWAYS cloud-based Disease, Abdominal Aortic Aneurysm, and platform, the Registry provides real-time Peripheral Lower Extremity Arterial Disease tracking of patients and outcomes that due to atherosclerosis. Medication details and can be used for quality improvement at a dosages, risk factor and lifestyle modifications, practitioner and institutional level. Outcomes non-operative treatments and counseling will can be evaluated against regional and be the emphasis of the VMC. The Registry will national benchmarks. In addition, providers help define the natural history of disease and have access to a large database for local, the impact of medical management. Features regional and national analysis. The SVS VQI is include a web-based platform with real-time organized as part of the Society for Vascular reporting. Surgery Patient Safety Organization (SVS PSO), which provides protection against discovery Dr. Josh Beckman, Dr. Marc Bonaca, and of comparative data in legal proceedings. former Association president Dr. Mark Creager Providers can submit outcome data in a secure are among those members serving on the environment, as the data will only be used for VMC Steering Committee to provide scientific quality improvement and cannot be publicly expertise and oversight. The team has worked reported. Regular audits help ensure data diligently to develop the VMC.“Vascular integrity and prevent selective reporting. diseases are prevalent in the U.S. and other nations, often resulting in significantly higher “We are extremely excited about the rates of major adverse cardiovascular events introduction of the Vascular Medicine Consult including heart attack, stroke and death.” Registry,” said Jens Jorgensen, MD, Medical said John Meiners, chief of mission aligned Director of the SVS VQI. “The effort and businesses and healthcare solutions for the collaboration put into the VMC will provide a American Heart Association. “This collaboration necessary platform for physicians to manage, will enable providers to identify the best analyze and improve outcomes for patients treatments and medicines to improve quality with peripheral arterial disease being treated of life and patient care.” with medical therapy. Data generated by the registry will directly support our goal of The American Heart Association, a global force improving care for medically managed for longer, healthier lives, has a longstanding patients.”treatments and medicines to improve commitment to improving systems of care quality of life and patient care.” through its quality improvement programs such as its flagship Get With The Guidelines® (GWTG) program, promoting consistent adherence to evidence-based guidelines in hospital and healthcare settings across the U.S. This team effort represents an opportunity to leverage the strengths of both organizations to improve care delivered to patients with vascular disease in the outpatient populations as well.

Dr. Randall DeMartino, MD and Dr. Michael R. Jaff, from the SVS serve as co-chairs of the

14 SVS VQI 2020 Annual Report 12. USING SVS VQI DATA FOR Objective Performance Criteria The treatment of infrainguinal occlusive COLLABORATIVE PROJECTS disease is undergoing rapid change with new Medical devices are an integral component stents, balloons, and other devices coming on of vascular healthcare. SVS VQI collects the market with increasing frequency. It has clinical data to help better understand device been more than 10 years since the publication performance. Data may be used to meet of objective performance criteria (OPC) for the regulatory requirements, support post-approval treatment of lower extremity occlusive disease. surveillance or expand existing labeling Regulatory approval of new devices often indications. requires comparison with the contemporary performance of existing techniques and SVS VQI has partnered with several device devices. OPCs can provide supplemental or manufacturers to provide aggregate data historical data for device evaluation in support for product development, creation of of approval. performance standards, and expansion of device indications. SVS VQI worked in collaboration with the Registry Assessment for Peripheral Arterial Post-Approval Surveillance Projects Devices (RAPID), the US FDA and industry to The use of SVS VQI data for post-approval develop contemporary OPCs for peripheral surveillance is consistent with the FDA vision vascular interventions for femoral-popliteal of registry-based evaluation throughout the artery disease. total product lifecycle. Initial projects have Daniel J. Bertges, Roseann White, Yu-Ching Cheng, Tianyi Sun, Niveditta Ramkumar, leveraged existing SVS VQI infrastructure and Philip P. Goodney, Rebecca W. Wilgus, Aaron E. Lottes et al. Registry Assessment of Peripheral Interventional Devices Objective Performance Goals for Superficial Femoral reduced recruitment time and expenses. For and Popliteal Artery Peripheral Vascular Interventions. Publication stage: In Press Journal Pre-Proof example, the Thoracic Aortic Dissection (TEVAR) Journal of Vascular Surgery. Published online: October 17, 2020. DOI:https://doi. org/10.1016/j.jvs.2020.09.030. project was completed in half the time initially estimated by industry sponsors, Medtronic and Registry Assessment of Peripheral Gore. Initiated in October 2014, this project Interventional Devices (RAPID) has demonstrated the value of expanding RAPID is a collaboration of professional surveillance to real-world device evidence societies (Society for Vascular Surgery, with faster than expected enrollment while American College of Cardiology, Society for meeting FDA requirements. In partnership with Interventional Radiology), academia, industry, Gore and Medtronic, the SVS PSO and M2S has CMS, private payers and EMRs. The goal is completed enrollment of the one-year and to develop a coordinated registry network five-year cohorts. For the Gore and Medtronic (CRN). The FDA, through the Medical Device cohort, we are currently beginning the 5-year Epidemiology Network (MDEpiNet), has follow-up. This project was re-opened in late promoted the concept of CRNs to generate 2019 to include the newly approved Cook real-world evidence about medical device Zenith® Dissection Endovascular Stent. TEVAR performance. centers have been invited to participate and the Project is now fully subscribed. Real world data is aggregated from multiple registries to evaluate and monitor endovascular devices and has been used to create OPC – see above. The initial phase (completed) was to develop core data elements and definitions that can be used by all registries and to incorporate unique device identifiers. A registry-based analysis of device performance in the SFA and popliteal artery, Superficial Femoral and Popliteal artery Evidence Development (SPEED) ,was used to create OPC for infrainguinal occlusive disease. A manuscript has been written and accepted for publication in the JVS.

www.VQI.org Transcarotid Artery Revascularization (TCAR) Surveillance Project (TSP) ACC, SVS JOIN FORCES ON SINGLE TSP is a unique effort that allows CMS to VASCULAR REGISTRY reimburse centers performing TCAR based on The American College of Cardiology and Society for Vascular a national coverage determination. Centers Surgery are collaborating on a single vascular registry to harness the strengths of both organizations in improving care and participate in the TSP by entering patients into outcomes of patients with vascular disease. the SVS VQI registry to allow the SVS PSO to assess the safety and efficacy of TCAR in comparison to “The combined strengths of ACC and SVS will provide a clear choice for clinicians, researchers, industry and the Food and the standard treatment, carotid endarterectomy. Drug Administration when looking for data on the management To date, more than 421 centers have contributed of vascular diseases,” said Fred Masoudi, MD, MPH, FACC, ACC more than 15,948 TCAR cases to the CAS registry. NCDR Management Board chair and chief scientific advisor. This represents the largest dataset of information Effective, January 2021, the ACC’s NCDR will collaborate with the SVS Vascular Quality Initiative (VQI) to support and steer on TCAR procedures. a single vascular registry. This registry will be operated by SVS,

Association of Transcarotid Artery Revascularization vs Transfemoral Carotid Artery Stenting creating a co-branded SVS VQI program that will be a unique, With Stroke or Death Among Patients With Carotid Artery Stenosis. Schermerhorn ML, Liang comprehensive resource for measuring and improving the care P, Eldrup-Jorgensen J, Cronenwett JL, Nolan BW, Kashyap VS, Wang GJ, Motaganahalli provided to a growing population of patients with vascular RL, Malas MB.JAMA. 2019 Dec 17;322(23):2313-2322. doi: 10.1001/jama.2019.18441.PMID: diseases. 31846015. In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative. Schermerhorn ML, Liang P, “The ACC NCDR and the SVS VQI are the two leading clinical Dakour-Aridi H, Kashyap VS, Wang GJ, Nolan BW, Cronenwett JL, Eldrup-Jorgensen J, Malas registries in the peripheral vascular space. A single registry MB.J Vasc Surg. 2020 Jan;71(1):87-95. doi: 10.1016/j.jvs.2018.11.029. Epub 2019 Jun 18.PMID: combines the resources and expertise from both organizations. 31227410. The impact of age on in-hospital outcomes after transcarotid artery revascularization, We are merging the best elements of both registries to create transfemoral carotid artery stenting, and carotid endarterectomy. Dakour-Aridi H, the premier vascular clinical registry,” said SVS PSO Medical Kashyap VS, Wang GJ, Eldrup-Jorgensen J, Schermerhorn ML, Malas MB.J Vasc Surg. 2020 Director Jens Jorgensen, MD. “We look forward to working Sep;72(3):931-942.e2. doi: 10.1016/j.jvs.2019.11.037. Epub 2020 Feb 5.PMID: 32035784. with the ACC and other medical society collaborators that will allow us to enrich the SVS VQI and improve the care of vascular patients.” Crest-2 Registry This randomized, controlled clinical trial Originating as the CARE Registry in 2006 and expanding scope compares CEA and CAS to best medical in 2014 to include lower extremity vascular catheter-based interventions, the ACC’s Peripheral Vascular Intervention (PVI) therapy, and the SVS SVS VQI is one of two Registry assesses the prevalence, demographics, management registries supporting the trial. Investigators must and outcomes of patients undergoing percutaneous treatment report their carotid artery stent procedures to for peripheral vascular disease. To date, the PVI Registry includes patient data from more than 200 institutions. be qualified for this trial and then report non- randomized procedures during the trial. This year SVS VQI began in 2010 as an expansion of the Vascular Study more than 142 interventionists used SVS VQI to Group of New England, which originated in 2003. More than 675 report more than 6678 CAS procedures for the centers participate in SVS VQI, which has 13 procedural-based registries encompassing the treatment of arterial and venous CREST-2 Registry project. SVS VQI participation disease as well as a disease-based registry collecting data on in the CREST-2 registry facilitates enrollment the medical management of aneurysms, carotid stenosis and and participation by leveraging SVS VQI lower extremity arterial occlusive disease. infrastructure. “The ACC is committed to working with all of our partners in cardiovascular care to create a cohesive source of vascular disease data,” said ACC President Athena Poppas, MD, FACC. “In combining our registry with that of SVS, we are providing uniform, actionable information for physicians and health systems.”

The new registry collaboration will provide greater opportunities to evaluate new and emerging technologies, pharmacologic therapies, and medical and lifestyle management. It will also provide a rich source of data for academicians, the FDA and industry looking to answer scientific questions about patient characteristics and outcomes and the use and effectiveness of different treatments.

“The SVS is proud of its history of working with other medical societies, government agencies and industry when developing quality improvement programs to improve the quality of vascular care,” said SVS President Ronald Dalman, MD. “Working with the ACC on this initiative is another example of how collaboration and inclusion can improve the services we offer to caregivers and our patients.”

SVS VQI 2020 Annual Report 13. THE SVS VQI AND 14. FUTURE DEVELOPMENTS COMPLIANCE WITH THE In 2021, the SVS VQI plans to support improved care and promote patient safety in the EUMDR following areas: The European Medical Device Regulation (EU •Continue to pilot the Vascular Ultrasound MDR) was introduced in 2017 to ensure high Registry, to collect and study vascular standards of quality and safety for medical laboratory images, initially focused on devices being used in Europe. It establishes a diagnosis and treatment of carotid artery framework for medical device monitoring to disease. This new and unique registry will match ensure a high level of health and safety while ultrasound images with SVS VQI clinical data in supporting innovation. While the new European the CEA and CAS registries. MDR includes pre-approval evaluation for medical device manufacturing, it adds a new •Infra-Inguinal and Supra-Inguinal registries total life-cycle approach to medical device will be revised in 2021, along with the Open regulation. AAA registry and Lower Extremity Amputation Registry. One of the most important but most challenging requirement of EU MDR is the •Enhanced Long Term follow up reporting active Post-Market Clinical Follow-up required capabilities with ability to drill down to patient to establish safety and performance during the level data will also be released in 2021. total lifecycle of a device. Manufacturers must report such data to maintain their CE mark for •Infra-Inguinal Bypass pilot of variables to each device by May 2020. Medstreaming/M2S help better manage the usage of Opioids in and the SVS VQI recognize the importance of Vascular procedures. supporting manufacturers and regulators, both domestic and international, to evaluate the safety and performance of vascular devices currently being used in daily practice. SVS VQI 15. CORPORATE SUPPORT collects much relevant data to provide real- Corporate Contributions to Ongoing SVS VQI world evidence needed to meet the new EU Programs MDR. The operations of the SVS PSO are financed by fees paid by participating sites. New “Manufacturers face significant challenges project development, including addition of in collecting real-world clinical follow-up new registries, quality reports, and improved data about ALL their devices,” said Jack functionality in SVS VQI has been made Cronenwett, MD, CMO Medstreaming/M2S. possible through generous unrestricted “In fact, some companies are now considering contributions by Quality Champion, the need to remove some currently CE- Quality Partner and Quality Associate-level marked devices from the European market corporations. Corporate sponsors of the SVS if they cannot obtain needed data. We are PSO for the past year are listed below: pleased to have supplied data from the SVS VQI to several manufacturers to help them successfully meet EU MDR requirements. Going Quality Champions forward, we believe that the SVS VQI and other quality improvement registries will be a primary data source to address current and future regulatory challenges faced by device manufacturers world-wide.”

Quality Partners

17 www.VQI.org APPENDICES

SVS VQI 2020 Annual Report APPENDIX A— VQI SITES LISTED BY STATE OR PROVINCE (AS OF 10/1/2020) CENTER NAME Baylor- The Heart Hospital Plano (TX) Doctors Hospital at Renaissance (TX) Abington Memorial Hospital (PA) Baylor University Medical Center (TX) Doylestown Hospital (PA) Abrazo Arizona Heart Hospital (AZ) Baystate Medical Center (MA) Dr. Ricardo Vasquez, MD (IN) Abrazo Arrowhead Campus (AZ) Beaufort Memorial Hospital (SC) Duke Raleigh Hospital (NC) AdventHealth Celebration (FL) Beebe Healthcare (DE) Duke Regional Hospital (NC) AdventHealth Orlando (FL) Berkshire Medical Center (MA) Duke University Medical Center (NC) AdventHealth Tampa (FL) Beth Israel Deaconess Medical Center (MA) East Alabama Medical Center (AB) Advocate Good Samaritan Hospital (IL) Beth Israel Medical Center (NY) Edward Hospital (IL) Advocate South Suburban Hospital (IL) Bethesda North Hospital (TriHealth, Inc.) (OH) Einstein Medical Center Montgomery (PA) Alamance Regional Medical Center (NC) Birmingham St. Vincent’s East Hospital (AL) Eisenhower Medical Center (CA) Albany Medical Center (NY) Bloomington Hospital (IN) Elkhart General Hospital (IN) Albany Vascular Specialist Center (GA) Bon Secours DePaul Medical Center (VA) Elliot Hospital (NH) Alexian Brothers Medical Center (IL) Bon Secours Maryview Medical Center (VA) Elmhurst Memorial Hospital (IL) Allegheny Health Network - Allegheny Clinic Bon Secours Memorial Regional Medical Center (VA) Emanuel Medical Center (CA) Vascular Surgery (PA) Bon Secours St. Francis Medical Center (VA) Emory Healthcare (GA) Allina- Abbott Northwestern Hospital (MN) Bon Secours St. Mary’s Hospital (VA) Emory St. Joseph’s Hospital (GA) Allina- Mercy Hospital (MN) Boston Medical Center (MA) Englewood Hospital and Medical Center (NJ) Allina- United Hospital (MN) Bridgeport Hospital (CT) Evansville Surgical Associates (IN) Allina- Unity Hospital (MN) Brigham and Women’s Hospital (MA) Excela Health (PA) Altru Health System (ND) Bronson Battle Creek Hospital (MI) Fairlawn Surgery Center (VA) AMITA Health Adventist Medical Center LaGrange (IL) Bronson Methodist Hospital (MI) Fairview Southdale Hospital (MN) AnMed Health Medical Center (AnMed Health) (SC) Brookwood Baptist Medical Center (AL) Fairview St. John’s Hospital (MN) Arizona Endovascular Center (AZ) Bryan Medical Center (NE) Fairview St. Joseph’s Hospital (MN) Arizona Vascular Specialists (AZ) BSA Hospital (TX) Flagstaff Medical Center (AZ) Arnett Hospital (IN) Camden Clark Medical Center (WV) Flint Hills Heart, Vascular, and Vein Clinic, LLC (KS) Arnot Health (NY) Cape Canaveral Hospital (FL) Florida Hospital Memorial Medical Center (FL) Artery and Vein Institute (PA) Cape Cod Hospital (MA) Florida Hospital Zephyrhills, Inc. (FL) Asante Rogue Regional Medical Center (Asante Capital Health Medical Center - Hopewell (NJ) Floyd Medical Center (GA) Health System) (OR) Capital Health Regional Medical Center (NJ) Forrest General Hospital Vascular Services (MS) Ascension Borgess Hospital (MI) Cardiothoracic and Vascular Surgical Associates (FL) Fort Sanders Regional Medical Center (TN) Ascension Providence Hospital, Novi Campus (MI) Carilion Roanoke Memorial Hospital (VA) Fox Valley Surgical Associates Ltd. (WI) Ascension Providence Hospital, Southfield Carle Foundation Hospital (IL) Franciscan Health Lafayette East (IN) Campus (MI) CarolinaEast Medical Center (NC) Froedtert Memorial Lutheran Hospital (WI) Ascension St. John Hospital (MI) Carson Tahoe Regional Hospital (NV) Geisinger Community Medical Center (PA) Aspirus Wausau Hospital, Inc. (WI) Catawba Valley Medical Center (NC) Geisinger Medical Center (PA) Associates in Vascular Care (NJ) Catholic Health Mercy Hospital of Buffalo (NY) Geisinger Wyoming Valley Medical Center (PA) AtlantiCare Regional Medical Center (AtlantiCare Catholic Health Sister of Charity Hospital (NY) Genesis Hospital (OH) Health System) (NJ) Cedars-Sinai Medical Center (CA) Genesis Medical Center, Davenport (IA) Atrium Health Carrabus (NC) Centra Health (Lynchburg General Hospital) (VA) Gilvydis Vein Clinic (IL) Atrium Health Pineville (NC) Central Florida Regional Hospital (FL) Glens Falls Hospital (NY) Atrium Health Union (NC) Central Maine Medical Center (ME) Good Samaritan Hospital (TriHealth, Inc.) (OH) AU Medical Center, Inc. (GA) CGH Medical Center (IL) Goshen Hospital (IN) Aultman Hospital (OH) Charleston Area Medical Center (WV) Gottlieb Memorial Hospital (Loyola University Aurora Baycare Medical Center (WI) Chester County Hospital (PA) Health System) (IL) Aurora Lakeland Medical Center (WI) Cheyenne Regional Medical Center (WY) Grady Memorial Hospital (GA) Aurora Medical Center in Kenosha (WI) Christiana Care Health System (DE) Great River Medical Center (IA) Aurora Medical Center in Manitowoc County (WI) Christus Highland Medical Center (LA) Guthrie Clinic (PA) Aurora Medical Center in Oshkosh (WI) Christus St. John Hospital (TX) Hackensack Meridian- Bayshore Community Aurora Medical Center in Summit (WI) Christus St. Michael Hospital (TX) Hospital (NJ) Aurora Medical Center in Washington County (WI) CHUM (Canada) Hackensack Meridian- Hackensack University Aurora Medical Center of Grafton (WI) CISSSO (Canada) Medical Center (NJ) Aurora Memorial Hospital of Burlington (WI) CJW Medical - Chippenham Hospital (VA) Hackensack Meridian- Jersey Shore University Aurora Sheboygan Memorial Medical Center (WI) CJW Medical - Johnston-Willis Hospital (VA) Medical Center (NJ) Aurora Sinai Medical Center (WI) Cleveland Clinic, Heart and Vascular Institute (OH) Hackensack Meridian- Ocean Medical Center (NJ) Aurora St. Luke’s Medical Center (WI) Clinton Memorial Hospital (OH) Hackensack Meridian- Riverview Medical Center (NJ) Aurora St. Luke’s South Shore (WI) Coastal Heart Medical Group (CA) Hackensack Meridian- Southern Ocean Medical Aurora West Allis Medical Center (WI) Coastal Vascular & Interventional, PLLC (FL) Center (NJ) Avera Heart Hospital of South Dakota (SD) Coastal Vein and Vascular Specialists (FL) Halifax Hospital Medical Center (FL) Avera McKennan Hospital (SD) Cobb Hospital, Inc. (WellStar Health System, Inc.) (GA) Harborview Medical Center (WA) Backus Hospital (CT) Columbia St. Mary’s Hospital Milwaukee, Inc. (WI) Harlingen Medical Center (TX) Bakersfield Memorial Hospital (CA) Columbia St. Mary’s Hospital Ozaukee, Inc. (WI) Harrison Medical Center (CHI Franciscan Health) (WA) Ball Memorial Hospital (IN) Columbia Surgical Services, Inc. (MO) Hartford Hospital (CT) Baltimore Washington Medical Center (MD) Columbia University Irving Medical Center (NY) Health Park Medical Center (Lee Memorial Health Banner Desert Medical Center (AZ) Columbus Regional Hospital (IN) System) (FL) Banner Heart Hospital (AZ) Community Hospital East (IN) HealthPartners, Inc. (MN) Banner--University Medical Center Phoenix (Banner Community Hospital Heart & Vascular (IN) Heart & Surgical Hospital (CA) Health) (AZ) Community Hospital South (IN) Heart Care Consultants, LLC (PA) Banner--University Medical Center Tucson (AZ) Concord Hospital (NH) Heart Hospital of Lafayette (LA) Baptist Health Louisville (KY) Cone Health Heart & Vascular Center (NC) Heart Hospital of New Mexico at Lovelace Baptist Health Madisonville- Jack L. Hamman Heart Confluence Health (WA) Medical Center (NM) & Vascular Center (KY) Cookeville Regional Medical Center (TN) Henrico Doctors’ Hospital (VA) Baptist Health Paducah (KY) Cooper University Medical Center (NJ) Henry Ford Allegiance Health (MI) Baptist Hospital of Miami (FL) Covenant Health - Grey Nuns Hospital (Canada) Henry Ford Hospital, Detroit (MI) Baptist Memorial Hospital- Memphis (TN) Covenant Healthcare (MI) Henry Ford Hospital, West Bloomfield (MI) Barnes Jewish Hospital (MO) Cox Medical Center South (MO) Henry Ford Macomb (MI) Bartow Regional Medical Center (FL) CTSA (NH) Hoenig Vascular Center (MA) Baton Rouge General Medical Center (LA) CTVS- CardioThoracic Vascular Surgeons (TX) Holmes Regional Medical Center (FL) Bayfront Health Seven Rivers (FL) Danbury Hospital (CT) Holy Spirit - Geisinger Affiliate (PA) Bayhealth Medical Center (DE) Dartmouth Hitchcock Medical Center (NH) HonorHealth Deer Valley Medical Center (AZ) Baylor All Saints Medical Center (TX) Deaconess Midtown Hospital (IN) HonorHealth Scottsdale Osborn Medical Center (AZ) Baylor- Jack and Jane Hamilton Heart and Deborah Heart and Lung Center (NJ) HonorHealth Scottsdale Thompson Peak Medical Vascular Hospital (TX) Decatur Memorial Hospital (IL) Center (AZ) Baylor Scott & White Medical Center - Irving (TX) Delray Medical Center, Inc. (FL) Horizon Vascular Specialists (MD) Baylor Scott & White Medical Center - McKinney (TX) Diagnostic Imaging of Milford (CT) Hospital of Central Connecticut (CT) Baylor Scott & White Medical Center -- Round Dixie Regional Medical Center (UT) Hospital of the University of Pennsylvania (PA) Rock (TX) DLP Conemaugh Memorial Medical Center, LLC (PA) Huntington Hospital (CA) Baylor- The Heart Hospital Denton (TX) DMC Harper University Hospital (MI) Huntsville Hospital (Huntsville Hospital Health 19 www.VQI.org APPENDIX A— VQI SITES LISTED BY STATE OR PROVINCE (AS OF 10/1/2020) System) (AL) MedStar Good Samaritan Hospital (MD) Nova Scotia Health Authority (Canada) Inova Alexandria Hospital (VA) MedStar Harbor Hospital (MD) Novant Health Forsyth Medical Center (NC) Inova Fair Oaks Hospital (VA) MedStar Montgomery Medical Center (MD) Novant Health Matthews Medical Center (NC) Inova Fairfax Hospital (VA) MedStar Southern Maryland Hospital Center (MD) Novant Health Presbyterian Medical Center (NC) Inova Gainesville Hospital (VA) MedStar Union Memorial Hospital (MD) NSLIJ- Lenox Hill Hospital (NY) Inova Loudoun Hospital (VA) MedStar Washington Hospital Center (DC) NSLIJ- Long Island Jewish Medical Center (NY) Inova Mount Vernon Hospital (VA) Memorial Health University Medical Center (GA) NSLIJ- North Shore University Hospital (NY) Integris Baptist Medical Center, Inc. (OK) Memorial Hermann Greater Heights Hospital (TX) NSLIJ- Staten Island Hospital- North Site (NY) Intermountain Medical Center (UT) Memorial Hermann Heart & Vascular Institute- NSLIJ-Southside Hospital (NY) Javon Bea Hospital--Riverside Campus (IL) Texas Medical Center (TX) NYU Langone Medical Center (NY) John Sealy Hospital, UTMB (TX) Memorial Hermann Katy Hospital (TX) NYU Winthrop Hospital (NY) John T. Mather Hospital (NY) Memorial Hermann Memorial City Medical Center(TX) Ocala Regional Medical Center (FL) Johns Hopkins Bayview Medical Center (MD) Memorial Hermann Northeast Hospital (TX) Ochsner Medical Center (LA) Kadlec (Providence) (WA) Memorial Hermann Southeast Hospital (TX) OhioHealth Doctors Hospital (OH) Kaleida- Buffalo General Hospital (NY) Memorial Hermann Southwest Hospital (TX) OhioHealth Dublin Methodist Hospital (OH) Kansas Heart Hospital (KS) Memorial Hermann Sugar Land (TX) OhioHealth Grady Memorial Hospital (OH) Kennedy University Hospital (NJ) Memorial Hermann The Woodlands Hospital (TX) OhioHealth Grant Medical Center (OH) Kennestone Hospital, Inc. (WellStar Health System, Memorial Hospital at Gulfport (MS) OhioHealth Mansfield Hospital (OH) Inc.) (GA) Memorial Hospital Belleville (IL) OhioHealth Marion General Hospital (OH) Kent Hospital (RI) Memorial Hospital of South Bend (IN) OhioHealth Riverside Methodist Hospital (OH) KentuckyOne Health- Jewish East (KY) Memorial Hospital Pembroke (FL) Oklahoma Heart Hospital South, LLC (OK) KentuckyOne Health- Jewish Hospital (KY) Memorial Hospital West (FL) Oklahoma Heart Hospital, LLC (OK) King’s Daughters Medical Center (KY) Memorial Medical Center (IL) Oklahoma Heart Institute at Hillcrest Medical Kootenai Health (ID) Memorial Regional Hospital (FL) Center (OK) Lake Health - West Medical Center (OH) Memorialcare Long Beach Medical Center (CA) Orange Regional Medical Center (NY) Lakeland Regional Medical Center (FL) Memorialcare Orange Coast Medical Center (CA) Oregon Health & Sciences University (OR) Lakes Region General Hospital (NH) Memorialcare Saddleback Medical Center (CA) Oregon Vascular Specialists, LLC (OR) Lakeview Regional Medical Center (LA) Menorah Medical Center (KS) Orlando Health, Inc. Dr. P. Phillips Hospital (FL) Lancaster General Hospital (PA) Mercy Hospital Springfield (MO) Orlando Health, Inc. Health Central Hospital (FL) Lawrence + Memorial Hospital (CT) Mercy Hospital St. Louis (MO) Orlando Health, Inc. Orlando Regional Medical Lee Memorial Health System (Gulf Coast Medical Mercy Medical Center- Baltimore (MD) Center (FL) Center) (FL) MercyOne Des Moines Medical Center (IA) Orlando Health, Inc. South Seminole Hospital (FL) Legacy Health (OR) MercyOne Siouxland Medical Center (IA) OSF- Saint Anthony Medical Center (IL) Lehigh Valley Hospital (PA) Methodist Dallas Medical Center (TX) OSF- Saint Francis Medical Center (IL) Lifespan- Rhode Island Hospital (RI) Methodist Hospital (IN) OSF- St. Joseph Medical Center (IL) Lifespan- The Miriam Hospital (RI) Methodist Richardson Medical Center (TX) OU Medical Center (OK) Loma Linda University Medical Center (CA) Miami Vein Center (FL) Our Lady of Lourdes Regional Medical Center, Inc. (LA) Los Robles Hospital & Medical Center (CA) Michigan Vascular Center (MI) Our Lady of the Lake (LA) Loyola University Medical Center (IL) Middlesex Hospital (Middlesex Health System) (CT) Overlake Hospital and Medical Center (WA) Lutheran Medical Center (CO) MidHudson Regional Hospital (NY) Overlook Hospital (Atlantic Health System) (NJ) Lyerly Baptist Neurosurgery (FL) Midland Memorial Hospital (TX) Owensboro Health Regional Hospital (KY) MacNeal Hospital (Loyola University Health MidMichigan Health - Midland (MI) Palmetto Health Richland (SC) System) (IL) MidState Medical Center (CT) Palo Alto Medical Foundation (CA) Maimonides Medical Center (NY) Midwest Institute Minimally Invasive Therapies (IL) Parkview Medical Center (CO) Main Line Hospitals, Inc. - Bryn Mawr Hospital (PA) Midwest Physician Alliance (Heart Care Center of Parkwest Medical Center (TN) Main Line Hospitals, Inc. - Lankenau Medical Illinois - Premier Vascular, LLC) (IL) PeaceHealth Sacred Heart Medical Center - Center (PA) Mission Hospital (NC) Riverbend (OR) Main Line Hospitals, Inc. - Paoli Hospital (PA) Mississippi Baptist Medical Center (MS) PeaceHealth Southwest Medical Center (WA) Main Line Hospitals, Inc. - Riddle Hospital (PA) Mobile Infirmary (AL) PeaceHealth St. Joseph Medical Center (WA) Maine Medical Center (ME) Mon Health Medical Center (WV) Penn Presbyterian Medical Center (PA) MaineGeneral Medical Center (ME) Montefiore Medical Center (NY) Penn State Milton S. Hershey Medical Center (PA) Marietta Memorial Hospital (OH) Morton Plant Hospital (FL) Pennsylvania Hospital (PA) Marin General Hospital (CA) Morton Plant North Bay (FL) Penrose St. Francis Health Services (Centura Health Marshfield Clinic Health System, Inc. (WI) Mosaic Life Care (MO) Corporation) (CO) Martin Medical Center (FL) Mount Sinai Hospital (NY) Peripheral Vascular Associates (TX) Mary Washington Hospital (VA) Mount Sinai Medical Center (FL) Piedmont Athens Regional Medical Center, Inc. (GA) Massachusetts General Hospital (MA) MultiCare Deaconess Hospital (WA) Piedmont Hospital Atlanta (GA) Maury Regional Medical Center (TN) MultiCare Good Samaritan Hospital (WA) Pima Vascular (Southern Arizona Vascular Institute) (AZ) Mayo Clinic Arizona (AZ) MultiCare Tacoma General Hospital (WA) PineHurst Surgical (NC) Mayo Clinic Florida (FL) Munson Medical Center (MI) Porter Adventist Hospital (Centura Health Mayo Clinic Health System - Franciscan Health Nashville Vascular & Vein Institute (TN) Corporation) (CO) care, Inc. (La Crosse) (WI) Nebraska Medical Center (NE) Portsmouth Regional Hospital (NH) Mayo Clinic Health System - Northwest Wisconsin Nebraska Methodist Hospital (NE) Presbyterian Hospital (NM) Region, Inc. (WI) New Hanover Regional Medical Center (NC) Presbyterian St. Luke’s Medical Center (CO) Mayo Clinic Hospital - Rochester (MN) New York-Presbyterian/Brooklyn Methodist (NY) ProHealth Care (Waukesha Memorial Hospital) (WI) McKay-Dee Hospital (UT) New York-Presbyterian/Queens (NY) ProMedica Toledo Hospital, Jobst Vascular (OH) McKenzie-Willamette Medical Center (OR) Newark Beth Isreal Medical Center (Barnabas Providence Alaska Medical Center (AK) McLaren Bay Region (MI) Health) (NJ) Providence Holy Cross Medical Center (CA) McLaren Flint (MI) Newtown-Wellesley Hospital (MA) Providence Holy Family Hospital (WA) McLaren Greater Lansing (MI) North Florida Regional Medical Center (FL) Providence Hospital (AL) McLaren Macomb (MI) North Memorial Health Hospital (MN) Providence Little Company of Mary, Torrance (CA) McLaren Northern Michigan (MI) North Mississippi Medical Center (MS) Providence Medford Medical Center (OR) McLaren Port Huron (MI) North Okaloosa Medical Center (FL) Providence Portland Medical Center (OR) McLeod Regional Medical Center (SC) Northeast Georgia Medical Center (GA) Providence Regional Medical Center (WA) Mease Countryside Hospital (FL) Northeast Methodist Hospital (TX) Providence Sacred Heart Medical Center (WA) Mease Dunedin Hospital (FL) NorthShore University Health- NorthShore Skokie Providence Saint Joseph Medical Center (CA) Medical Center Hospital (TX) Hospital (IL) Providence St. Mary Medical Center (WA) Medical City Dallas (TX) Northside Hospital Atlanta (GA) Providence St. Peter Hospital (WA) Medical City Denton (TX) Northside Hospital Cherokee (GA) Providence St. Vincent Medical Center (OR) Medical City Fort Worth (TX) Northside Hospital Forsyth (GA) Providence Tarzana Medical Center (CA) Medical City Plano (TX) Northwestern Medicine Central DuPage Hospital (IL) Radiology Associates - Fox Valley (WI) Medical Faculty Associates, Inc. (DC) Northwestern Memorial Hospital (IL) Redmond Regional Medical Center (GA) Medical University of South Carolina Hospital (SC) Norton Healthcare, Inc. - Norton - Audubon (KY) Regents of the University of New Mexico (NM) MedStar Cardiology Associates (MD) Norton Healthcare, Inc. - Norton - Brownsboro (KY) Regional Medical Center of Orangeburg & MedStar Franklin Square Medical Center (MD) Norton Healthcare, Inc. - Norton - Downtown (KY) Calhoun Co (SC) MedStar Georgetown University Hospital (DC) Norton Healthcare, Inc. - NWCH - St. Matthews (KY) Reid Health (IN) Norwalk Hospital (CT) 20 SVS VQI 2020 Annual Report APPENDIX A— VQI SITES LISTED BY STATE OR PROVINCE (AS OF 10/1/2020)

Rex Hospital, Inc. (NC) St. Joseph’s Medical Center of Stockton (Dignity UCHA- Memorial Hospital Central (CO) Riverside Regional Medical Center (VA) Health) (CA) UCLA- Ronald Reagan Medical Center (CA) Roper St. Francis Hospital (SC) St. Luke’s Campus (Mohawk Valley Health System) (NY) UCSD Medical Center (CA) Rose Medical Center (CO) St. Luke’s Healthcare- St. Luke’s Regional Medical UCSF Medical Center (CA) Royal Oak (William Beaumont Hospital) (MI) Center (ID) UF Health- Shands Hospital (FL) Rush Foundation Hospital (MS) St. Luke’s Hospital - Allentown Campus (PA) UNC Hospitals (NC) Russell C. Lam MD PA (TX) St. Luke’s Hospital - Anderson Campus (PA) United Health Services Hospitals, Inc. (NY) Rutgers Robert Wood Johnson Medical School (NJ) St. Luke’s Hospital - Bethlehem Campus (PA) United Hospital Center (WV) Sacred Heart Hospital of the Hospital Sisters of the St. Luke’s Hospital - Monroe Campus (PA) UnityPoint Health- Des Moines (IA) Third Order of St. Francis (WI) St. Luke’s Hospital - Quakertown Campus (PA) UnityPoint Health- Meriter Hospital (WI) Saint Alphonsus Regional Medical Center (ID) St. Luke’s Hospital - Warren Campus (NJ) Univeristy of Washington Medical Center Saint Barnabas Medical Center (Barnabas Health) (NJ) St. Luke’s Hospital (MN) (Montlake Campus) (WA) Saint Francis Hospital and Medical Center (CT) St. Luke’s Hospital (MO) University Hospitals Ahuja Medical Center (OH) Saint Joseph Hospital (CO) St. Luke’s Methodist Hospital (IA) University Hospitals Cleveland Medical Center (OH) Saint Joseph Hospital (KY) St. Luke’s Roosevelt Hospital Center (NY) University of Alabama (AL) Saint Joseph Regional Medical Center (IN) St. Mary Corwin Medical Center (Centura Health University of Arkansas Medical Sciences (AR) Saint Joseph’s Hospital (GA) Corporation) (CO) University of Chicago Medical Center (IL) Saint Luke’s Hospital of Kansas City (MO) St. Mary Medical Center (PA) University of Cincinnati Medical Center (OH) Saint Luke’s Memorial Hospital, Inc. (PR) St. Mary’s Hospital (CO) University of Colorado - Denver (CO) Saint Thomas Midtown Hospital (TN) St. Mary’s Hospital (WI) University of Colorado - North Vascular Services (CO) Saint Thomas Rutherford Hospital (TN) St. Mary’s Medical Center (WV) University of Connecticut Health Center (CT) Saint Thomas West Hospital (TN) St. Patrick Hospital (Providence) (MT) University of Iowa (IA) Salem Health (OR) St. Peter’s Hospital (St. Peter’s Health Partners) (NY) University of Kansas Medical Center (KA) San Diego Vascular Associates (CA) St. Vincent Healthcare (MT) University of Kentucky (KY) Sanford Clinic Vascular Associates (SD) St. Vincent Heart Center of Indiana, LLC (IN) University of Maryland Medical Center (MD) Sanger Heart and Vascular Institute (NC) St. Vincent Hospital and Health Care Center, Inc. (IN) University of Massachusetts Memorial Hospital (MA) Sarasota Memorial Hospital (FL) St. Vincent Hospital of the Hospital Sisters of the University of Michigan (MI) Saxony Hospital (IN) Third Order of St. Francis (WI) University of Minnesota Medical Center (UMMC) (MN) Scott & White Memorial Hospital (TX) St. Vincent’s Medical Center (CT) University of Mississippi Medical Center (MS) Scripps Green Hospital (Scripps Health) (CA) Stamford Hospital (CT) University of Missouri Medical Center (MO) Scripps Memorial Hospital La Jolla (Scripps Health) (CA) Stanford Hospital and Clinics (CA) University of Oklahoma School of Community Seattle Vascular Surgery (WA) Steward Good Samaritan Medical Center, Inc. (MA) Medicine (OK) Self Regional Healthcare (SC) Steward St. Anne’s Hospital Corporation (MA) University of Tennessee Medical Center (TN) Sentara Careplex Hospital (VA) Steward Trumbull Memorial Hospital, Inc. (OH) University of Texas Health Science Center, Sentara Leigh Hospital (VA) Stockton Cardiothoracic Surgical Medical Group (CA) San Antonio (TX) Sentara Martha Jefferson (VA) Stony Brook University Medical Center (NY) University of Utah Hospital and Clinics (UT) Sentara Norfolk General Hospital (VA) Straub Medical Center (HI) University of Vermont Medical Center (VT) Sentara Northern Virginia (VA) Strong Memorial Hospital, University of Rochester University of Washington Medical Center Sentara Obici Hospital (VA) Medical Center (NY) (Northwest Campus) (WA) Sentara Princess Anne Hospital (VA) Suburban Hospital (MD) University of Wisconsin Hospitals and Clinics Sentara RMH Medical Center (VA) Summa Health System (OH) Authority (WI) Sentara Virginia Beach General Hospital (VA) Sunnybrook Health Sciences Centre (Canada) University Surgical Associates (TN) Sentara Williamsburg Regional Medical Center (VA) SUNY Upstate- University Hospital Medical Center (NY) UPMC Altoona (PA) Sequoia Hospital (Dignity Health) (CA) Superior Vein Care, PLLP (ID) UPMC Western Maryland (MD) Shannon Medical Center (TX) Surgical Specialists of Central Florida (FL) UPMC/ UPP Vascular Surgery (PA) Sharp Grossmont Hospital (CA) Swedish Cherry Hill (Providence) (WA) UPMC/Hamot Hospital (PA) Sharp Memorial Hospital (CA) Swedish Edmonds (Providence) (WA) Utah Valley Hospital (UT) SIH - Memorial Hospital of Carbondale (IL) Swedish First Hill (Providence) (WA) UVA Medical Center (UVA Health System) (VA) Singapore General Hospital Pte Ltd (Singapore) Tallahassee Memorial HealthCare, Inc. (FL) ValleyCare (CA) SIU School of Medicine, Memorial Medical Center (IL) Tampa General Hospital (FL) Vanderbilt University Medical Center (TN) Slidell Memorial Hospital (LA) Tenet Florida Physicians Services, LLC (FL) Vanguard Vascular & Vein (TX) South Florida Baptist (FL) The Christ Hospital (OH) Vascular & General Surgical Specialists of SWFL (FL) South Miami Hospital (FL) The Johns Hopkins Hospital (MD) Vascular Institute of Chattanooga (TN) Southcoast- Charlton Memorial Hospital (MA) The Medical Center of Aurora (CO) Vascular Institute of Michigan (MI) Southcoast- St. Luke’s Hospital (MA) The Medical Center, Navicent Health (The Medical Vascular Surgery Associates (FL) Southwest Healthcare System (CA) Center of Central Georgia, Inc.) (GA) Venice Regional Bayfront Hospital (FL) Space Coast Vascular (FL) The Methodist Medical Center of Illinois (IL) Verde Valley Medical Center (AZ) Spartanburg Regional Health Services District, Inc. (SC) The MetroHealth System (OH) Vidant Medical Center (NC) Spectrum Health Hospital (MI) The Ohio State University, Wexner Medical Center (OH) Virginia Commonwealth University Hospital SSM DePaul Health Center (MO) The Practice of John F Lucas III, M.D. (MS) Authority (VA) SSM Health St. Louis University Hospital (MO) The Reading Hospital and Medical Center (PA) Virginia Mason (WA) SSM St. Anthony Hospital (OK) The University of Arizona Medical Center- University Wadley Regional Medical Center (TX) SSM St. Clare Health Center (MO) Campus (AZ) Wake Forest Baptist Health (NC) SSM St. Joseph Health Center (MO) The University of California Irvine Medical Center (CA) WakeMed Health & Hospitals -- Cary Campus (NC) SSM St. Mary’s Health Center (MO) The University of Southern California on WakeMed Health & Hospitals -- Raleigh Campus (NC) St. Anthony Lakewood (Centura Health behalf of its Keck Medicine of USC (CA) Washington Hospital Health System (CA) Corporation) (CO) The University of Texas M.D. Anderson Cancer Weill Cornell Medical College (NY) St. Anthony Medical Center (CHI Franciscan Center (TX) Weiss Memorial Hospital (IL) Health) (WA) The University of Texas Southwestern Medical WellSpan York Hospital (PA) St. Anthony’s Hospital (FL) Center (TX) West Hospital (IN) St. Anthony’s Medical Center (MO) The Valley Hospital (NJ) West Jefferson Medical Center (LA) St. Charles Health System, Inc. (OR) The Vein and Vascular Institute of Tampa Bay (FL) West Tennessee Heart and Vascular Center (TN) St. Clair Hospital (PA) Thomas Jefferson University Hospitals, Inc. (PA) West Virginia University Hospitals, Inc. (WV) St. Dominic’s Memorial Hospital and Medical Thunder Bay Regional Health Sciences Centre Westchester Medical Center (NY) Associates (MS) (Canada) White Plains Hospital (NY) St. Elizabeth’s Medical Center (MA) Tift Regional Medical Center (GA) White Square Vascular Surgery (MD) St. Francis Heart Center (IN) Toronto General Hospital (Canada) Willis-Knighton North (LA) St. Francis Medical Center (CHI Franciscan Health) (WA) Tradition Medical Center (Martin Memorial Winchester Medical Center (VA) St. John’s Health Center (Providence) (CA) Medical Center, Inc.) (FL) Winter Haven Hospital (FL) St. John’s Hospital (IL) Trident Medical Center (SC) Yale New Haven Hospital (CT) St. Joseph Medical Center (MO) TriStar Centennial Medical Center (TN) Yavapai Regional Medical Center (AZ) St. Joseph Medical Center (CHI Franciscan Health) (WA) TriStar Summit Medical Center (TN) St. Joseph Mercy Health System (MI) Tucson Medical Center (AZ) St. Joseph’s Hospital (FL) Tufts Medical Center (MA) St. Joseph’s Hospital North (FL) Turkey Creek Medical Center (TN) St. Joseph’s Hospital South (FL) UC Davis Health System (CA) 21 www.VQI.org APPENDIX B— SOCIETY FOR APPENDIX C— MEDSTREAMING/ VASCULAR SOCIETY PATIENT M2S CLINICAL PLATFORM SAFETY ORGANIZATION (SVS PSO) M2S PATHWAYS™ is a secure, cloud-based solution which enables physicians, institutions, clinical data managers, and The Patient Safety and Quality Improvement Act of 2005 researchers to collect, manage, analyze, and disseminate authorized the creation of Patient Safety Organizations their clinical data to achieve optimal outcomes. Accessible (PSOs) to improve the quality and safety of health care by any computer with a compatible browser, PATHWAYS is by the collection and analysis of patient data. It protects designed to easily integrate into a variety of workflows by any comparative outcome analyses or other aggregated allowing multiple users to access and enter data on a single reports that is generated by a PSO from discovery in state procedure form, and to spread the responsibilities of data and federal court. These analyses and reports, called entry to more than one individual. Authentication identifies Patient Safety Work Products (PSWP) can be used for quality users’ roles and permissions to ensure appropriate access to content within PATHWAYS. Real-time data validation through improvement but not for disciplinary action against a error-trapping and alerts ensure that only high-quality data provider. It allows patient identifiers to be collected, without is populated into the system. PATHWAYS has been designed specific IRB or patient approval. This permits a PSO to to support large-scale quality improvement and research match patients with other data sources, such as the Social projects as dynamic content within registries can easily be Security Death Index or Medicare claims data to evaluate added and/or modified. long-term effectiveness of procedures in terms of mortality or complications. The identity of patients, hospitals and Medstreaming-M2S is a medical informatics company providers cannot be disclosed by a PSO, although non- specializing in workflow productivity technology, registry identifiable data can be published for quality improvement development and support services. To address challenges research, adhering to both PSO and HIPAA requirements. created by fragmentation of clinical data, Medstreaming created specialty-based workflow applications, which SVS VQI embraced the use of a PSO to house its activities, improves data workflow in electronic medical records (EMR) because it provides substantially more security and systems. Using this clinical workflow expertise, Medstreaming protection than most registries. has also developed an integrated platform application that runs as an outpatient EMR, image management and reporting, and practice management workflow solution. All Medstreaming solutions act as aggregators for structuring VQI ENDORSING SOCIETIES clinical data which in turn creates powerful data service American Venous Forum* offerings for multi-purpose, web based, data mining Canadian Society for Vascular Surgery and data analytics. Medstreaming is headquartered Eastern Vascular Society in Redmond, WA. M2S, a division of Medstreaming, is a Florida Vascular Society healthcare performance management solutions company Georgia Vascular Society that provides innovative technology and services for the Michigan Vascular Society healthcare industry to manage clinical information and Midwestern Vascular Surgical Society utilize that information to improve the quality of patient New England Society for Vascular Surgery care and reduce costs. The SVS Vascular Quality Initiative New York Society for Vascular Surgery is built on M2S’s PATHWAYS clinical data performance Peripheral Vascular Surgery Society platform, allowing users to track, measure, and analyze clinical information, promote collaboration, objectively drive Rocky Mountain Vascular Society decisions, and optimize performance. For more information, Society for Clinical Vascular Surgery visit www.m2s.com. Society for Vascular Medicine* Society of Interventional Radiology* Society for Vascular Ultrasound* Southern Association for Vascular Surgery Southern California Vascular Surgical Society Vascular Access Society of America* Western Vascular Society

*Members of SVS PSO Governing Council

23 SVS VQI 2020 Annual Report 2019 Detailed Annual Report