vascularqualityinitiative.org

Annual Report of Industry-Related ActivitiesReport of the SVS PSO Vascular Technology Council - 2015

The Vascular Technology Council is responsible for the use of VQI data to evaluate and improve the safety and effectiveness of vascular devices within the SVS PSO. This includes optimizing technology and patient selection for current and developing devices. The goal is to efficiently use data collected in the VQI for multiple stakeholders, including the FDA and device manufacturers, in order to meet regulatory requirements and aid the development of new devices. Important progress of the VQI related to these activities is listed below. The Vascular Technology Council thanks all the companies that support the VQI, especially those participating and contributing to the Corporate Support Program. We see great value in collaboration and are committed to growing this network and supporting device innovation through the VQI.

Corporate Roundtable

During the past year, the Vascular Technology Council has held quarterly meetings with Corporate Roundtable representatives to discuss opportunities to evaluate and improve vascular device performance using VQI. The importance of addressing issues collectively cannot be overstated. Medical device industry representatives bring decades of experience and skills ranging from device usage, legal issues, regulatory considerations, and most valuable information to be obtained from registries. This contribution has allowed the SVS PSO to make more informed decisions and policies.

Annual Corporate Support Program

Through the success of the 2015 Corporate Support program, a number of important VQI enhancements were completed this year. These include the release of the Varicose Vein Registry, updates to the EVAR Registry including device and anatomical details, push reporting to centers, hospital systems and physicians, the addition of Kaplan-Meier reporting to calculate one-year event rates, and an EHR data import system to reduce duplicate data entry. These projects were made possible by generous support from Quality Champions ($100,000 contribution level) and Quality Partners ($50,000 contribution level) shown on this page.

Supplementing Existing Registry Data for More Rapid Device Evaluation

While much data has been collected in VQI regarding peripheral arterial interventional devices, historical data did not contain details of device manufacturer, or certain details of treatment that might be needed for a device evaluation project. In 2015, the SVS PSO initiated a new type of project

to quickly create a device performance goal by supplementing already collected index procedure and one-year follow-up data with new data added by sites that had performed these procedures. After identifying existing procedures that met the requirements for the project, relevant sites were invited to contribute a small amount of additional data to fulfill the project requirements. This provided the necessary comparative device data, including already existing one-year follow-up, within five months, as opposed to prospectively collecting this data over an estimated three years. This provides a model for very efficient data collection by merging existing VQI data with site supplemented data to meet regulatory requirements using real world data.

New VQI Projects Planned for 2016

With multiple stakeholders and VQI members now benefiting from registry data, there have been many important suggestions to improve and expand the scope of VQI. These include revising the PVI Registry to include device manufacturer and additional clinical detail; a new registry to evaluate the Medical Management of PAD (to allow comparison with surgical and interventional treatment); increased EHR data integration capability; collection of hospital charge data to calculate cost, and linking this information with VQI clinical data for accurate, anonymous benchmarking; automated reports to improve IVC Filter removal; and development of a web-based patient reported outcomes system. With continued industry support, VQI plans to develop many of these projects during 2016.

Fred Weaver MD, Chair, on behalf of the Vascular Technology Council: Jose Almeida MD, Adam Beck MD, Christopher Kwolek MD, Jack Cronenwett MD and Meridith Mitchell.

2015 QUALITY CHAMPIONS 2015 QUALITY PARTNERS

Gore and Medtronic TEVAR Aortic Dissection Device Post-Approval Surveillance

This project is a collaboration with the FDA, WL Gore and Medtronic to meet post-approval regulatory requirements for new endovascular devices used to treat patients with Type B aortic dissection. These new devices were approved by the FDA with broad indications for use (beyond the acute, complicated cases evaluated in pre-market trials) with the requirement that 200 acute and 200 chronic type B dissection patients, with follow-up out to 5 years, be evaluated in a post-market surveillance project with VQI. This project is designed to improve the selection of and

treatment strategy for patients with Type B aortic dissection. Dissection-related mortality, device technical success, and device procedural success will be the primary endpoints. Although this project will include an evaluation of device performance, the more interesting aim is to provide an overall assessment dissection treatment using endografts, including false lumen characteristics over time and the need for additional dissection-related interventions.

This project was initiated in October 2014, and was projected by industry standards to require 3 years to enroll 400 patients. As shown in the above graph, this project is proceeding much more rapidly than expected, and will be fully enrolled in 1.5 years. This relates to the existing network of VQI sites already entering TEVAR data, uniform contracting with sites by the SVS PSO, not requiring informed consent or IRB approval for this PSO project. It underscores the efficiency of using registry data for multiple stakeholders and the value of real-world VQI data to accurately understand device performance.

Current VQI-Industry Collaborative Project UpdatesVQI Mission

The mission of the Vascular Quality Initiative (VQI) is to improve the quality, safety, effectiveness and cost of vascular health care by collecting and exchanging information.

The VQI uses the structure of a Patient Safety Organization (PSO) to permit collection of patient-identified information for quality improvement purposes without the need for specific patient consent or IRB approval.

All major vascular procedures are monitored using the M2S PATHWAYS web-based system.

Since vascular devices are critical to this care, the SVS PSO recognizes the importance of working with industry and the FDA to help evaluate and improve device safety and efficacy.

This report summarizes VQI activities related to the vascular device industry this year.

Lombard Aorfix Endovascular AAA Device Post-Approval Surveillance

The Aorfix endograft received FDA approval in February 2013 with the requirement for post-approval surveillance of an additional 234 procedures in the VQI registry. Due to the highly angulated aortic necks being treated by this device, 5-year follow-up with annual imaging was required, with core lab CT measurements provided by M2S on behalf of sites to the SVS PSO to combine with clinical data for this project. An interesting feature of the project will be a comparison of CT with ultrasound imaging, when the latter are done in real world practice in patients without apparent need for CT scanning. This project began in December 2014, and already 17 sites have entered 26 procedures, with plans for extended follow-up using the dynamic content provided by M2S for VQI sites that voluntarily participate in these device evaluation projects.

VQI Registries

Carotid Artery Stent

Carotid Endarterectomy

Endovascular AAA Repair

Thoracic and Complex EVAR

Open AAA Repair

Hemodialysis Access

Inferior Vena Cava Filter

Infra-Inguinal Bypass

Supra-Inguinal Bypass

Lower Extremity Amputation

Peripheral Vascular Intervention

Varicose Vein

* Peripheral Arterial Disease

Management

OVER 250,000 PROCEDURES IN THE

REGISTRY (as of October 2015)

*To be released in 2016

For more information on our Data Sharing portfolio, please contact Meridith Mitchell at 603.738.0066 or email mitchell@m2s.com

Vascular Flow Spiral Laminar Flow Dialysis Access Graft Post-Approval Project

Recognizing that devices may perform differently in real world use after FDA approval based on focused pre-market trials, Vascular Flow Technologies partnered with VQI this year to evaluate their recently approved Spiral Laminar Flow™ Graft for use in dialysis access. Unique characteristics of this graft are designed to reduce turbulence and intimal hyperplasia at the distal anastomosis, to promote the improved patency observed in pre-market studies. The performance of this new device is being monitored through a new project with VQI, to allow comparison with the performance of devices without the laminar flow design. Non-identifiable data will be shared with Vascular Flow Technologies from this project and a Scientific Committee of the SVS PSO will analyze and publish the outcomes. This project was just launched in August, and is open to all VQI centers participating in the dialysis access registry.

Registry Assessment of Peripheral Arterial Devices (RAPID) Project

RAPID is a project sponsored by the Medical Device Epidemiology Network (MDEpiNet) public-private partnership. It has participation by the FDA, industry, and relevant specialty registries, with Co-chairs Jack Cronenwett (VQI), Pablo Morales (FDA) and Robert Thatcher (CSI). It is designed to develop a core minimum data set for assessment of devices used to treat infrainguinal peripheral arterial disease. Phase I will derive data elements from existing registries and industry case report forms by a workgroup of all stakeholders, and will include a standardized approach to include device identifiers using Access GUDID. Phase II will develop data extraction interoperability across registries and hospital EHRs for future projects, and Phase III will develop a coordinated registry network (CRN) prospective device evaluation project to support a regulatory decision. VQI is enthusiastic about this potential to further enhance the effectiveness of its partnership with FDA and industry.

Industry Opportunities for Device Evaluation using VQI and M2S Pathways

Efficient use of registry data by multiple stakeholders to improve vascular care is the foundation of VQI. Important aspects of VQI include its real-world representation of hospital types and physician specialties, insuring consecutive case entry by auditing claims data, one-year follow-up in the registry, ability to link Medicare claims and Social Security Death Index for longer follow-up, and streamlined recruitment through the existing network and Pathways data collection system. Costs are reduced by simplifying site contracting, avoiding IRB fees and supplementing existing data forms rather than creating a duplicate data entry system. Furthermore, it is possible to use current or historic VQI data to create a control group or objective performance goals. The ability to create dynamic content within PATHWAYS, incorporate M2S core lab imaging, and supplement existing data with required elements (see page 1) can greatly speed project completion.

It is important to recognize that retrospective or prospective projects to evaluate devices can be done within VQI, and even IDE studies can be done using the M2S PATHWAYS platform, to take advantage of the existing network of > 350 real-world centers participating in VQI.

Annual Reports for Quality Champions

In 2015 the VQI provided device evaluation reports to Bard, Gore and Medtronic, which compared their devices anonymously with all others, or which provided insight into the patient/procedure characteristics of vascular treatment. These reports can guide the development of new products, evaluate new products, or understand device use in the real-world marketplace. Unique reports are created for each Quality Champion through consultation with VQI representatives to meet their specific needs.

Vascular  Surgery  

Radiology  

Vascular  Surgery  General  Surgery  Cardiac  Surgery  Radiology  Cardiology  Neurosurgery  Other  

15%    Radiology  

42%  Vascular  Surgery    

4%  

5%  

16%  Cardiology  

10%  

Over 2,700 Specialists Performing All Procedures

Abington Memorial Hospital (PA)Alamance Regional Medical Center (NC)Albany Vascular Specialist Center (GA)Allina - 4 CentersAltru Hospital (ND)Athens Regional Medical Center (GA)Augusta Health (VA)Aultman Hospital (OH)Aurora - 14 CentersBaptist Health Madisonville- Jack L. Hamman Heart & Vascular Center (KY)Baptist Hospital of Miami (FL)Baptist Memorial Hospital- Memphis (TN)Baton Rouge General Medical Center ()BayCare- St. Anthony’s Hospital (FL)Baylor - 5 CentersBaystate Medical Center (MA)Beaufort Memorial Hospital (SC)Beaumont - 3 CentersBeebe Healthcare (DE)Berkshire Medical Center (MA)Beth Israel Deaconess Medical Center (MA)Boston Medical Center (MA)Brigham and Women’s Hospital (MA)Camden Clark Medical Center (WV)Cardiovascular Medicine PC - 2 CentersCarilion Roanoke Memorial Hospital (VA)Carolinas Healthcare - Pineville (NC)Carolinas Healthcare System- Sanger Heart & Vascular Institute (NC)Carondelet Specialists Group (AZ)Carroll Hospital Center (MD)Carson Tahoe Regional Hospital (NV)Catholic Health - 4 CentersCatholic Medical Center (NH)Cedars-Sinai Medical Center (CA)Central Maine Medical Center (ME)Centura - 2 CentersCharleston Area Medical Center (WV)Charlotteville Radiology LTD & CRL Surgical (VA)CHI Health Nebraska Heart (NE)Christiana Care Health System (DE)CJW Medical - 2 CentersCleveland Clinic, Heart and Vascular Insitute (OH)Coastal Vascular & Interventional, PLLC (FL)Community Hospital - 3 CentersConcord Hospital (NH)Cone Health Heart & Vascular Center (NC)Cooper University Medical Center (NJ)CardioThoracic Vascular Surgeons (TX) Danbury Hospital (CT)Dartmouth Hitchcock Medical Center (NH)Dignity Health (Sequoia Hospital) (CA)DLP Conemaugh Memorial Medical Center DMC Harper University Hospital (MI)Dr E Gardner MD PC (TN)Duke University Medical Center (NC)Eastern Maine Medical Center (ME)El Camino Hospital (CA)Elliot Hospital (NH)Emory Healthcare (GA)Exempla- Saint Joseph Medical Center (CO)Fairview - 2 CentersFletcher Allen HealthCare (VT)Florida Hospital- Orlando (FL)Floyd Medical Center (GA)Froedtert Memorial Lutheran Hospital (WI)Geisinger Medical Center 3 Centers

Grady Memorial Hospital (GA)Guthrie Clinic (PA)Harborview Medical Center (WA)Hartford Hospital (CT)Heart Hospital of New Mexico at Lovelace Medical Center (NM)Henry Ford Hospital - 2 CentersHill Country Memorial Hospital (TX)Hoag Memorial Hospital Presbyterian (CA)Hoenig Vascular Center (MA)Horizon Vascular Specialists (MD)Houston Methodist St. John Hospital- Clear Lake (TX)Inova - 7 CentersIowa Heart Center at Mercy Medical Center (IA)IU Health- 6 CentersJackson Madison County General Hospital (TN)John Sealy Hospital, UTMB (TX)Johns Hopkins Bayview Medical Center (MD)Kadlec (Providence) (WA)Kaleida- Buffalo General Hospital (NY)Kennedy University Hospital (NJ)KentuckyOne Health - 2 CentersKing’s Daughters Medical Center (KY)Lakes Region General Hospital (NH)Lifespan -2 CentersLoma Linda University Medical Center (CA)LSU Health Science Center - Shreveport (LA)Maimonides Medical Center (NY)Maine Medical Center (ME)MaineGeneral Medical Center (ME)Marin General Hospital (CA)Mary Washington Hospital (VA)Maryland Vascular Specialist (MD)Massachusetts General Hospital (MA)Mayo Clinic - 3 CentersMcLaren Flint (MI)McLeod Regional Medical Center (SC)Medical University of South Carolina Hospital (SC)MedStar- Washington Hospital Center (DC)Memorial Hermann Heart & Vascular Institute- Texas Medical Center (TX)Memorial Hermann Southwest Hospital (TX)Memorial Hospital of South Bend (IN)Memorial Regional Hospital (FL)Memorial Univ Health Medical Center- SHVI (GA)Mercy Hospital (ME)Mercy Hospital - 2 CentersMercy Medical Center (OH)Mercy Medical Center- Baltimore (MD)Meridian- 5 CentersMedical Faculty Associates Physician Group (DC)Miami Vein Center (FL)Michigan Vascular Center (MI)Midstate Medical Center (CT)Mission Hospital (NC)Montefiore Medical Center (NY)Mouint Sinai- Beth Israel Hospital (NY)Mount Carmel - 3 CentersMount Sinai Hospital (2 Centers)Nashville Vascular & Vein Institute (TN)NorthShore University Health- NorthShore Skokie Hospital (IL)Northside - 3 CentersNorthwest Hospital & Medical Center (WA)

Northwestern Medicine Central DuPage Hospital (IL)Northwestern Memorial Hospital (IL)Novant Health - 3 CentersNSLIJ- 4 CentersNYP/Weill Cornell Medical College (NY)Ochsner Medical Center (LA)OhioHealth - 6 CentersOregon Health & Sciences University (OR)Orlando Health- 3 CentersOSF- 3 CentersOur Lady of the Lake Overlook Hospital (Atlantic Health System) (NJ)Palm Beach Gardens Medical Center (Cleveland Clinic) (FL)Palmetto Health Richland (SC)Palo Alto Medical Foundation (CA)Penn State Milton S. Hershey Medical Center (PA)Peripheral Vascular Associates (TX)Piedmont Hospital Atlanta (GA)Premier Surgical Associates, PLLC (TN)Presbyterian Hospital (NM)Presbyterian St. Luke’s Medical Center (CO)ProHealth Care (Waukesha Memorial Hospital) (WI)ProMedica Toledo Hospital, Jobst Vascular (OH)Providence - 13 CentersRapid City Regional Hospital (SD)Redmond Regional Medical Center (GA)Regional Medical Center of Orangeburg & Calhoun Co (SC)Rockford Memorial Hospital (IL)Roper St. Francis Hospital (SC)Saint Alphonsus Regional Medical Center (ID)Saint Francis Hospital and Medical Center (CT)Saint Joseph Regional Medical Center (IN)Saint Thomas - 3 CentersSan Fernando Valley Vascular Group (CA)Sanford Clinic Vascular Associates (SD)Sarasota Memorial Hospital (FL)Scott & White Memorial Hospital (TX)Scripps Green Hospital (Scripps Health) (CA)Self Regional Healthcare (SC)Sentara - 9 Centers Sharp - 3 CentersSIU School of Medicine, Memorial Medical Center (IL)South Miami Hospital (FL)Southcoast- 2 CentersSpartanburg Regional Health Services District, Inc. (SC)Spectrum Health Hospital (MI)SSM - 4 CentersSt. Agnes Healthcare (MD)St. Anthony’s Medical Center (MO)St. Elizabeth’s Medical Center (MA)St. Francis Heart Center (IN)St. John’s Health Center (Providence) (CA)St. Luke’s Healthcare- St. Luke’s Regional Medical Center (ID)St. Luke’s Hospital & Health Network (PA)St. Luke’s Hospital (MO)St. Luke’s Hospital (MN)St. Mary’s Hospital- Decatur (IL)St. Mary’s Medical Center (WV)St. Patrick Hospital (Providence) (MT)St. Vincent Healthcare (MT)

St. Vincent - 2 CentersStanford Hospital & Clinics (CA)Strong Memorial Hospital, University of Roches-ter Medical Center (NY)Summa Health System (OH)SUNY - 3 CentersSwedish - 3 CentersTallahassee Memorial Hospital (FL)Tampa Cardiovascular Associates (FL)Tampa General Hospital (FL)Texas Health Presbyterian Hospital Dallas (TX)The Hospital of Central Connecticut (CT)The Johns Hopkins Hospital (MD)The MetroHealth System (OH)The Ohio State University, Wexner Medical Center (OH)The Practice of John F Lucas III, M.D. (MS)The Practice of Stephen M. Ryan, MD (IL)The Reading Hospital and Medical Center (PA)The University of Arizona Medical Center- University Campus (AZ)The Vein and Vascular Institute of Tampa Bay (FL)Tift Regional Medical Center Toronto General Hospital Trident Medical Center (SC)Tufts Medical Center (MA)UC Davis Health System (CA)UCHA- Memorial Hospital Central (CO)UCLA- 2 CentersUCSD Medical Center (CA)UCSF Medical Center (CA)UF Health- Shands Hospital (FL)UnityPoint Health - 3 CentersUniveristy of Washington Medical Center (WA)University Hospitals Health System (OH)University of Arkansas (AR)University of Chicago Medical Center (IL)University of Colorado, Denver (CO)University of Kansas Medical Center (KA)University of Maryland Medical Center (MD)Univ of Massachusetts Memorial Hospital (MA)University of Michigan (MI)University of Mississippi Medical Center (MS)University of Missouri Medical Center (MO)University of North Carolina Hospitals (NC)University of Tennessee Medical Center (TN)Univ of Texas Health Science Center, San Antonio (TX)University of Texas MD Anderson Center (TX)University of Toledo Medical Center (OH)University of Utah Hospital and Clinics (UT)UPENN- University of Pennsylvania (PA)UPMC - 2 CentersUSC University Hospital- Keck Hospital (CA)UVA Health System (VA)Vascular Care of Metrowest, P.C. (MA)Vascular Center of Northern Michigan (MI)VCP- Vascular Care Partners (MA)Vidant Medical Center (NC)Wake Forest Baptist Health (NC)Weiss Memorial Hospital (IL)West Penn- 5 CentersWestchester Medical Center (NY)Winchester Medical Center (VA)Winthrop University Hospital (NY)Yale-New Haven Hospital (CT)

350+ Participating VQI Centers and Health Systems