4/14/2016 FINANCIAL DISCLOSURE FINANCIAL DISCLOSURE How Far Should We Go with the Endovascular Treatment of Advanced PAD in the Era of Health Care Reform? An Endocompetent Vascular Surgeon’s View I Have No Financial Relationships to Disclose I Have No Financial Relationships to Disclose Bruce A. Perler, MD, MBA Bruce A. Perler, MD, MBA Endovascular Procedures: Specialty Endovascular Procedures: Specialty Peripheral Revascularization (Medicare): 1996 - 2006 Peripheral Revascularization (Medicare): 1996 - 2006 J Vasc Surg, 2009 J Vasc Surg, 2009 J Vasc Surg, 2009 J Vasc Surg, 2009 1
4/14/2016 Admissions: 642,433 Published Outcomes: OPEN vs ENDO Published Outcomes: OPEN vs ENDO Years: 2003 - 2011 103 Reports: 1976 - 2006 103 Reports: 1976 - 2006 DURATION OF FOLLOW-UP DURATION OF FOLLOW-UP Open Open M o Endo Endo n t h s JACC, 2016 JACC, 2016 Lipsitz, VEITH 2008 Lipsitz, VEITH 2008 How Far Should We Go with the Endovascular Treatment of Advanced PAD? Femoro-Popliteal Revascularization Femoro-Popliteal Revascularization TASC II TASC II Bypass Surgery Endovascular Therapy PTA PTA +/- Stent Stent - Vein - Prosthetic - Balloons - Balloon Expandable Stents - Self-Expanding Stents - Cutting Balloons - Drug-Coated Balloons - Drug-Eluting Stents - Covered Stents - Bioabsorbable Stents - Cryoplasty - Brachytherapy - Laser - Atherectomy - Percutaneous Bypass J Vasc Surg, 2007 J Vasc Surg, 2007 2
4/14/2016 AFFORDABLE CARE ACT AFFORDABLE CARE ACT - 3 Goals - - 3 Goals - � Health Care Coverage for the Uninsured � Health Care Coverage for the Uninsured � Increase Regulation of Private Health Insurers � Increase Regulation of Private Health Insurers � Reduce Healthcare Spending (“bend the curve”) � Reduce Healthcare Spending (“bend the curve”) Impact of ACA on Medicare Spending Impact of ACA on Medicare Spending Source: Kaiser Family Foundation Source: Kaiser Family Foundation 3
4/14/2016 HEALTH CARE REFORM: Medicare Spending HEALTH CARE REFORM: Medicare Spending “ Today health care is moving away from “ Today health care is moving away from � Value-Based Purchasing: - Rewards for Quality Outcomes - Penalties for Readmission the old-fashioned, volume-driven, fee-for-service, the old-fashioned, volume-driven, fee-for-service, � Reductions in Annual Updates for Hospitals fragmented health care approach towards a fragmented health care approach towards a � Bundled Payments Over a Longer Episode of Care value-based, health-based system ” value-based, health-based system ” � Accountable Care Organizations - Shared Savings Programs Ronald R. Peterson, President Ronald R. Peterson, President The Johns Hopkins Hospital & Health System The Johns Hopkins Hospital & Health System � Independent Payment Advisory Board (IPAB) How Far Should We Go with the Endovascular Treatment of Advanced PAD? TASC II TASC II J Vasc Surg, 2007 J Vasc Surg, 2007 4
4/14/2016 Patients: 427 Patients: 427 Patients: 110 Lesions: 499 Lesions: 499 Bypass Grafts: 124 TASC TASC - AK (32%) - BK (50%) A: 26 (5.2%) A: 26 (5.2%) - Tibial (18%) B: 140 (28.1%) B: 140 (28.1%) C: 168 (33.7%) C: 168 (33.7%) 30-Day Mortality: 0.8% D: 165 (33.1%) D: 165 (33.1%) Follow-Up (mean): 77 mos Fem-Pop Bypass Grafts J V asc Surg, 1986 90% 90% 87% 87% 70% 63% Mt. Sinai Hospital , New York Mt. Sinai Hospital , New York Ann Vasc Surg, 2011 Ann Vasc Surg, 2011 University Hospital, Basel University Hospital, Basel World J Surg, 2011 World J Surg, 2011 Patients: 192 PTA / Stent Procedures: 239 Patency: Vein Diameter Patency: Vein Diameter Primary Patency 55% P< .001 22% Huntington Memorial Hosp. U Southern California Huntington Memorial Hosp. U Southern California J Vasc Surg, 2007 J Vasc Surg, 2007 J Vasc Surg, 2011 J Vasc Surg, 2011 5
4/14/2016 Procedures: 506 Procedures: 506 Patients: 127 Patients: 127 Patients: Patients: 472 472 Limbs: 139 Limbs: 139 Claudication: 37% Claudication: 37% PTFE Fem-Pop: 46 PTFE Fem-Pop: 46 Mortality: 0.8% Mortality: 0.8% PTA / S: 93 PTA / S: 93 F/U: 0-48 (median, 12.4) mos. F/U: 0-48 (median, 12.4) mos. Primary Patency Primary Patency 25% SUNY, Buffalo SUNY, Buffalo J Vasc Surg, 2008 J Vasc Surg, 2008 J Vasc Surg, 2008 J Vasc Surg, 2008 Procedures: 495 Procedures: 495 Pancreatic Cancer Pancreatic Cancer Patients: 482 Patients: 482 F/U: 0-34 (mean, 8.6) mos. F/U: 0-34 (mean, 8.6) mos. Survival Survival Subintimal Angioplasty 33% Ann J Radiol, 2007 Ann J Radiol, 2007 J Vasc Surg, 2010 J Vasc Surg, 2010 6
4/14/2016 Recurrent Glioblastoma Recurrent Glioblastoma Patients: 63 Claudication: 65% Survival Survival TASC C / D: 89% 33% BMJ, 2004 BMJ, 2004 Ann Vasc Surg, 2011 Ann Vasc Surg, 2011 Patients (C/D): 148 Patients (C/D): 148 Patients: 86 Patients: 86 VIABAHN: 76 VIABAHN: 76 Limbs: 100 Limbs: 100 Stent: 72 Stent: 72 TASC: TASC: Lesion Length (mean): 18 cm . Lesion Length (mean): 18 cm . A: 18 A: 18 B: 56 B: 56 Covered Stents C: 11 C: 11 Covered Stents Covered Stents Primary Patency D: 15 D: 15 Primary Patency Primary Patency TASC C & D Secondary Patency Secondary Patency 25.9% p= .392 24.2% Secondary Patency Secondary Patency Assisted Primary Patency Assisted Primary Patency 89% 89% 80% 70% p= .304 p= .04 Baylor University Medical Center Baylor University Medical Center J Vasc Surg, 2013 J Vasc Surg, 2013 J Vasc Surg, 2009 J Vasc Surg, 2009 7
4/14/2016 Patients: 474 Patients: 474 Patients: DES: 236 DES: 236 (Length: 66 mm) (Length: 66 mm) Viabahn 72 (19 cm) (Length: 63 mm) (Length: 63 mm) PTA: 238 PTA: 238 BMS 69 (17 cm) PTA Failure: 100 PTA Failure: 100 DES: 61 DES: 61 Heparin-Bonded Covered Stents Heparin-Bonded Covered Stents BMS: 59 BMS: 59 Drug Eluting Stents Drug Eluting Stents J V asc Surg, 1986 Fem-Pop Bypass Grafts JACC, 2015 JACC, 2015 J Am Coll Cardiol, 2013 J Am Coll Cardiol, 2013 DES: 236 (Length: 66 mm) (Length: 66 mm) (Length: 63 mm) (Length: 63 mm) PTA: 238 Circulation, 2016 Circulation, 2016 8
4/14/2016 LEVANT 2 LEVANT 2 • Patients: 476 • Patients: 476 • Claudication: 92% • Claudication: 92% • Lesion Length: < 15 cm • Lesion Length: < 15 cm Drug Coated Balloons Drug Coated Balloons 65.2% 90% 90% 87% 87% 52.6% 70% 63% N Engl J Med, 2015 9
4/14/2016 IN.PACT SFA IN.PACT SFA Patients: 858 Patients: 858 • Patients: 331 • Patients: 331 PTA: 517 (60%) PTA: 517 (60%) • Stenosis Length: < 18 cm • Stenosis Length: < 18 cm Bypass: 341 (40%) Bypass: 341 (40%) • Occlusion Length: < 10 cm • Occlusion Length: < 10 cm Years: 2000 - 2007 Years: 2000 - 2007 • Mean Lesion Length • Mean Lesion Length 8.94 vs 8.81 cm LIMB SALVAGE LIMB SALVAGE Drug Coated Balloons Drug Coated Balloons P p < .0001 Helsinki University General Hospital Helsinki University General Hospital Eur J Vasc Endovasc Surg, 2010 Eur J Vasc Endovasc Surg, 2010 JACC, 2015 JACC, 2015 Patients: 192 PTA / Stent Procedures: 239 Primary Patency “ The definition of insanity is “ The definition of insanity is doing the same thing over and doing the same thing over and 55% over and expecting a different over and expecting a different P< .001 result. ” result. ” 22% Albert Einstein Albert Einstein Huntington Memorial Hosp. U Southern California Huntington Memorial Hosp. U Southern California J Vasc Surg, 2011 J Vasc Surg, 2011 10
4/14/2016 Patients: Patients: 192 BMS: 71 (TASC D 12%) PTA/Stent Procedures: 239 (Claud. 48%) SG: 63 (TASC D 40%) (Claud. 63%) Consequences of Stent Failure Consequences of Stent Failure Huntington Memorial Hosp. U So. Cal Huntington Memorial Hosp. U So. Cal J Vasc Surg, 2013 J Vasc Surg, 2013 J Vasc Surg, 2011 J Vasc Surg, 2011 VSGNE VSGNE BASIL TRIAL BASIL TRIAL Patients: 1,880 LEBs Patients: 1,880 LEBs Prior PVI: Prior PVI: 603 (32%) 603 (32%) Years: 2003 - 2009 Years: 2003 - 2009 Patients: 452 Patients: 452 One Year: One Year: Bypass vs Endovascular Bypass vs Endovascular Graft Occlusion Rate Amputation Rate Graft Occlusion Rate Amputation Rate Amputation-Free Survival Amputation-Free Survival J Vasc Surg, 2010 J Vasc Surg, 2010 J Vasc Surg, 2011 J Vasc Surg, 2011 11
4/14/2016 Deductibles Deductibles Copayments Copayments 12
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