A Coordinated Registry Network Based on the Vascular Quality Initiative: VISION. Vascular Implant Surveillance & Interventional Outcomes Network

Transcription

1 A Coordinated Registry Network Based on the Vascular Quality Initiative: VISION Vascular Implant Surveillance & Interventional Outcomes Network Philip P. Goodney, MD, MS Chair, Research Advisory Committee Society for Vascular Surgery Patient Safety Organization Jack Cronenwett, MD, Art Sedrakyan, MD PhD MDEpiNet (FDA 1U01FD )

2 Launched by Society for Vascular Surgery in 2011 Mission: To improve the quality, safety, effectiveness and cost of vascular health care by collecting and exchanging information.

3 Why this is a good idea

4 Why this is a good idea DP 66 year old male 6.2 cm AAA 2013

5 Why this is a good idea DG 66 year old male 6.2 cm AAA 2014

6 Why this is a good idea DG 66 year old male 6.2 cm AAA 2015

7 Why this is a good idea DG 66 year old male 6.2 cm AAA 2016

8 Why this is a good idea DG 66 year old male 6.2 cm AAA No Symptoms 2016

9 Why this is a good idea DG 66 year old male 6.2 cm AAA 2016 No Symptoms 3 Different Surgeons, 2 Different Hospitals

10 Why this is a good idea DG 66 year old male 6.2 cm AAA 2016 No Symptoms 3 Different Surgeons, 2 Different Hospitals Risk of Mortality if His Aneurysm Ruptures = 50%

11 Why this is a good idea DG 66 year old male 6.2 cm AAA 2016 Reliable Surveillance After Vascular Care is a Key Priority for Patients, Providers, Payers, and Regulatory Agencies

12 Devices are a Key Aspect of Vascular Treatment Vascular Treatment Carotid Endarterectomy Carotid Artery Stent Endovascular AAA Repair Open AAA Repair Peripheral Vascular Intervention Infra Inguinal Bypass Supra Inguinal Bypass Thoracic and Complex EVAR Hemodialysis Access Lower Extremity Amputation IVC Filter Varicose Veins Devices Included Patch Type Stent, Protection Device Type Stent Graft Type Prosthetic Graft Type Balloon/Stent/Atherectomy Devices Prosthetic Graft Type Prosthetic Graft Type Stent Graft Type Graft Type Bandage, prosthesis type Device Type Ablation Device, Sclerosants

13 Devices are a Key Aspect of Vascular Treatment Vascular Treatment Carotid Endarterectomy Carotid Artery Stent Endovascular AAA Repair Open AAA Repair Peripheral Vascular Intervention Infra Inguinal Bypass Supra Inguinal Bypass Thoracic and Complex EVAR Hemodialysis Access Lower Extremity Amputation IVC Filter Varicose Veins Devices Used for Treatments Patch Type Stent, Protection Device Type Stent Graft Type Prosthetic Graft Type Balloon/Stent/Atherectomy Devices Prosthetic Graft Type Prosthetic Graft Type Stent Graft Type Graft Type Bandage, prosthesis type Device Type Ablation Device, Sclerosants

14 Opportunity for a Coordinated Research Network Need for data comparing device, treatment types Little consensus about best treatment methods Carotid endarterectomy vs. stenting Peripheral artery bypass vs. interventional treatment Open vs endovascular aortic treatment

15 Opportunity for a Coordinated Research Network Need for data comparing device, treatment types Little consensus about best treatment methods Carotid endarterectomy vs. stenting Peripheral artery bypass vs. interventional treatment Open vs endovascular aortic treatment Lack of high quality data about long term outcomes Most studies have limited follow up, often 1 year at most Difficulty in systematic data collection

16 Our VISION for the Data In VISION Clinical and Technical Data Available in Registries about procedures, patients, and devices

17 Our VISION for the Data In VISION Clinical and Technical Data Available in Registries about procedures, patients, and devices Long term, generalizable follow up using linkages to Medicare Claims, Under 65 data sources, PCORnet, and other sources

18 Our VISION for the Data In VISION Clinical and Technical Data Available in Registries about procedures, patients, and devices Long term, generalizable follow up using linkages to Medicare Claims, Under 65 data sources, PCORnet, and other sources National repository of Linked Analytic Datasets within VISION

19 Our VISION for the Data In VISION Clinical and Technical Data Available in Registries about procedures, patients, and devices Long term, generalizable follow up using linkages to Medicare Claims, Under 65 data sources, PCORnet, and other sources National repository of Linked Analytic Datasets within VISION Low Cost, but High Value Data for generalizable, real world effectiveness research in vascular care

20 Our VISION for the Data In VISION Clinical Registry and Technical Data Available in Registries Data about procedures, patients, and devices Long term, generalizable follow up Data using linkages to Medicare Partners Claims, Under 65 data sources, PCORnet, and other sources Successful National repository of Linked Clinical Claims CRN Analytic Datasets for VISION Low Cost, but High Value Data for generalizable, real world effectiveness research

21 National Registries for All Major Vascular Procedures Carotid disease Endarterectomy and stenting Aortic disease Open and endovascular abdominal aneurysm repair Endovascular repair thoracic aorta Lower extremity arterial disease Bypass, interventional procedures, amputation Medical Management of PAD (in development) Dialysis access Vena cava filters Varicose veins

22 Participating Center Growth VQI Participating Centers 376 Centers, 45 States + Ontario Oct 09 Jun 10 Oct 10 Feb 11 Jun 11 Oct 11 Feb 12 Jun 12 Oct 12 Feb 13 Jun 13 Oct 13 Feb 14 Jun 14 Oct 14 Feb 15 Jun 15 Feb 10 Oct 15 Feb 16

23 17 Regional Quality Groups AK HI

24 Total Procedures Captured (as of 3/1/2016) 278,080 Peripheral Vascular 87,659 Intervention Carotid Endarterectomy 64,285 Infra Inguinal Bypass 29,113 Endovascular AAA Repair 25,634 Hemodialysis Access 23,984 Carotid Artery Stent 10,422 Supra Inguinal Bypass 9,901 Open AAA Repair 7,972 Thoracic and Complex EVAR 5,762 IVC Filter 4,740 Lower ExtremityAmputations 4, , , , , , , , , ,000 75,000 50,000 25,000 0 VQI Total Procedure Volume Jan 14 Feb 14 Mar 14 Apr 14 May 14 Jun 14 Jul 14 Aug 14 Sep 14 Oct 14 Nov 14 Dec 14 Jan 15 Feb 15 Mar 15 Apr 15 May 15 Jun 15 Jul 15 Aug 15 Sep 15 Oct 15 Nov 15 Dec 15 Jan 16 Feb 16 Varicose Vein 3,456

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26 Society for Vascular Surgery Patient Safety Organization ( Allows systematic PHI Collection Without Need for Consent

27 Current linkages. Start With VQI Data Mr. Jones (name, SS#) Clinical Factors (comorbidities) Implant Data (Graft XYZ) Surgical Details (how it was placed) Surgeon Details Hospital Information Short term complications

28 Current linkages. Start With VQI Data Data Linkages to Medicare Claims The Dartmouth Institute Mr. Jones (name, SS#) Clinical Factors (comorbidities) Implant Data (Graft XYZ) Surgical Details (how it was placed) Surgeon Details Hospital Information Short term complications

29 Current linkages. Start With VQI Data Data Linkages to Medicare Claims The Dartmouth Institute Mr. Jones (name, SS#) Clinical Factors (comorbidities) Implant Data (Graft XYZ) Surgical Details (how it was placed) Surgeon Details Hospital Information Short term complications Measure Long Term Events: Survival Effectiveness of the Procedure Long Term Device Failures/Revisions

30 Current Data Linkage Algorithms

31 Current Data Linkage Algorithms Three Years of Pilot Work Developing Algorithms with 80 90% Match Success Rates

32 What Will We Measure? Procedure Medicare Data Source Death Hospital Readmissions Serious Adverse Outcomes Repeat procedures and reinterventions Postsurgical Follow up Imaging Aortic Aneurism Procedures Open abdominal aneurism repair (OPEN) Part A & B X X Aortic Rupture Bowel Obstruction Hernia Repair OPEN, EVAR, TEVAR, Endoleak, other graftrelated problems Endovascular aortic repair (EVAR) Part A & B X X Aortic Rupture OPEN, EVAR, TEVAR, Endoleak, other graftrelated problems Thoracic endovascular aortic repair (TEVAR) Part A & B X X Aortic Rupture OPEN, EVAR, TEVAR, Endoleak, other graftrelated problems Ultrasound or CT Ultrasound or CT Carotid Stenosis Procedures Carotid endarterectomy (CEA) Part A X X Stroke CEA or CAS MRI, Ultrasound or CT Carotid angioplasty and stenting (CAS) Part A X X Stroke CEA or CAS MRI, Ultrasound or CT Lower Limb Revascularization Peripherial vascular intervention (PVI) Infra inguinal revascularization (INFRA) Supra inguinal revascularization (SUPRA) Part B X X Amputation Inflow or outflow Open or endovascular Part B X X Amputation Inflow or outflow Open or endovascular Part B X X Amputation Inflow or outflow Open or endovascular MRI, Ultrasound or CT MRI, Ultrasound or CT MRI, Ultrasound or CT

33 What Will We Measure? Procedure Medicare Data Source Death Hospital Readmissions Serious Adverse Outcomes Repeat procedures and reinterventions Postsurgical Follow up Imaging Aortic Aneurism Procedures Open abdominal aneurism repair (OPEN) Part A & B X X Aortic Rupture Bowel Obstruction OPEN, EVAR, TEVAR, Endoleak, other graftrelated problems Hernia Repair Our goal is to establish a CRN Endovascular aortic repair (EVAR) Part A & B X X Aortic Rupture OPEN, EVAR, TEVAR, Ultrasound or CT Endoleak, other graftrelated problems Thoracic endovascular aortic repair Part A & B X X Aortic Rupture OPEN, EVAR, TEVAR, Ultrasound or CT for follow up, surveillance, and (TEVAR) Endoleak, other graftrelated problems Carotid Stenosis Procedures effectiveness for more than Carotid endarterectomy (CEA) Part A X X Stroke CEA or CAS MRI, Ultrasound or CT 300,000 patients nationwide Carotid angioplasty and stenting Part A X X Stroke CEA or CAS MRI, Ultrasound or CT (CAS) Lower Limb Revascularization Peripherial vascular intervention (PVI) across all vascular care Part B X X Amputation Inflow or outflow Open or endovascular MRI, Ultrasound or CT Infra inguinal revascularization (INFRA) Supra inguinal revascularization (SUPRA) Part B X X Amputation Inflow or outflow Open or endovascular Part B X X Amputation Inflow or outflow Open or endovascular MRI, Ultrasound or CT MRI, Ultrasound or CT

34 Advantages, Disadvantages, and Opportunities Advantages of Linked Clinical Claims Registries Medicare allows us to follow nearly all vascular care providers Low cost, generalizable matching and surveillance Real world practice patterns and devicespecific outcomes Disadvantages Probabilistic matching Lack of sidedness in outcomes, no under 65 Need for auditing strategies Solutions 3 years of experience, and plans for identified matching with GDIT ICD 10 External auditing efforts underway

35 Low Cost, But High Value Potential End User Patients Providers Industry Payers Product they can leverage The best long term information about the effectiveness of their treatments Low cost, national surveillance networks Distributed network for integrating real world practice Monitoring of effectiveness and practice trends Advantages Real world, nearly realtime data Not isolated in trials or within industry Opportunity for partnership Provider collaboration for monitoring

36 Summary: VISION is a CRN for National Vascular Care FDA and other Stakeholders Including Patients Device Companies for PAS and Surveillance VQI Based VISION Link to PCORI CDRN Vascular Implant Surveillance and Interventional Outcomes Network Link to Medicare, Commercial Claims and All Payer NY Data Inter National Registries

37 VISION Conclusions Registry based CRN is a pragmatic and efficient way to create a device surveillance system Allows partnership with major stakeholders to build a sustainable infrastructure Leverages national investment in data systems (PCORI CDRN, Medicare, State, Professional Society data) FDA 1U01FD Art Sedrakyan, Principal Investigator