4/14/2016. How Far Should We Go with the Endovascular Treatment of Advanced PAD in the Era of Health Care Reform?

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1 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 Bruce A. Perler, MD, MBA I Have No Financial Relationships to Disclose Peripheral Revascularization (Medicare): Endovascular Procedures: Specialty J Vasc Surg, 2009 J Vasc Surg,

2 Admissions: 642,433 Years: Published Outcomes: OPEN vs ENDO 103 Reports: DURATION OF FOLLOW-UP Open M o n t h s Endo JACC, 2016 Lipsitz, VEITH 2008 How Far Should We Go with the Endovascular Treatment of Advanced PAD? TASC II Femoro-Popliteal Revascularization Bypass Surgery Endovascular Therapy - Vein - Prosthetic - Balloons PTA - Cutting Balloons - Drug-Coated Balloons PTA +/- Stent Stent - Balloon Expandable Stents - Self-Expanding Stents - Drug-Eluting Stents - Covered Stents - Bioabsorbable Stents J Vasc Surg, Cryoplasty - Brachytherapy - Laser - Atherectomy - Percutaneous Bypass 2

3 AFFORDABLE CARE ACT - 3 Goals - Health Care Coverage for the Uninsured Increase Regulation of Private Health Insurers Reduce Healthcare Spending ( bend the curve ) Impact of ACA on Medicare Spending Source: Kaiser Family Foundation 3

4 HEALTH CARE REFORM: Medicare Spending Today Value-Based health Purchasing: care is moving away from - Rewards for Quality Outcomes - Penalties for Readmission the old-fashioned, volume-driven, fee-for-service, Reductions in Annual Updates for Hospitals fragmented health care approach towards a Bundled Payments Over a Longer Episode of Care value-based, health-based system Accountable Care Organizations - Shared Ronald Savings R. Peterson, Programs President 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 J Vasc Surg,

5 Patients: 110 Bypass Grafts: AK (32%) - BK (50%) - Tibial (18%) 30-Day Mortality: 0.8% Follow-Up (mean): 77 mos Fem-Pop Bypass Grafts J Vasc Surg, 1986 Patients: 427 Lesions: 499 TASC A: 26 (5.2%) B: 140 (28.1%) C: 168 (33.7%) D: 165 (33.1%) 90% 70% 87% 63% University Hospital, Basel World J Surg, 2011 Mt. Sinai Hospital, New York Ann Vasc Surg, 2011 Patients: 192 PTA / Stent Procedures: 239 Patency: Vein Diameter Primary Patency 55% P< % Huntington Memorial Hosp. U Southern California J Vasc Surg, 2011 J Vasc Surg,

6 Primary Patency Patients: 127 Limbs: 139 PTFE Fem-Pop: 46 PTA / S: 93 Procedures: 506 Patients: 472 Claudication: 37% Mortality: 0.8% F/U: 0-48 (median, 12.4) mos. 25% SUNY, Buffalo J Vasc Surg, 2008 J Vasc Surg, 2008 Pancreatic Cancer Survival Subintimal Angioplasty Procedures: 495 Patients: 482 F/U: 0-34 (mean, 8.6) mos. 33% Ann J Radiol, 2007 J Vasc Surg,

7 Recurrent Glioblastoma Survival Patients: 63 Claudication: 65% TASC C / D: 89% 33% BMJ, 2004 Ann Vasc Surg, 2011 Covered Stents Primary Patency Patients (C/D): 148 VIABAHN: 76 Stent: 72 Lesion Length (mean): 18 cm. 25.9% Primary Patency Covered Stents TASC C Secondary & D Patency Patients: 86 Limbs: 100 TASC: A: 18 B: 56 C: 11 D: 15 p= % Assisted Primary Patency p=.04 89% 70% Secondary Patency 89% 80% p=.304 J Vasc Surg, 2013 Baylor University Medical Center J Vasc Surg,

8 Heparin-Bonded Covered Stents Patients: Viabahn 72 (19 cm) BMS 69 (17 cm) Patients: 474 DES: 236 (Length: 66 mm) PTA: 238 (Length: 63 mm) PTA Failure: 100 DES: 61 BMS: 59 Drug Eluting Stents J Vasc Surg, 1986 Fem-Pop Bypass Grafts JACC, 2015 J Am Coll Cardiol, 2013 DES: 236 PTA: 238 (Length: 66 mm) (Length: 63 mm) Circulation,

9 LEVANT 2 Patients: 476 Claudication: 92% Lesion Length: < 15 cm Drug Coated Balloons 65.2% 90% 70% 87% 63% 52.6% N Engl J Med,

10 Drug Coated Balloons IN.PACT SFA Patients: 331 Stenosis Length: < 18 cm Occlusion Length: < 10 cm Mean Lesion Length 8.94 vs 8.81 cm Patients: 858 PTA: 517 (60%) Bypass: 341 (40%) Years: LIMB SALVAGE Pp<.0001 JACC, 2015 Helsinki University General Hospital Eur J Vasc Endovasc Surg, 2010 Patients: 192 PTA / Stent Procedures: 239 Primary Patency The definition of insanity is doing the same thing over and over and expecting a different result. P< % 22% Albert Einstein Huntington Memorial Hosp. U Southern California J Vasc Surg,

11 Patients: 192 PTA/Stent Procedures: 239 Consequences of Stent Failure Patients: BMS: 71 (TASC D 12%) (Claud. 48%) SG: 63 (TASC D 40%) (Claud. 63%) Huntington Memorial Hosp. U So. Cal J Vasc Surg, 2011 J Vasc Surg, 2013 BASIL TRIAL Amputation-Free Survival Patients: 452 Bypass vs Endovascular VSGNE Patients: 1,880 LEBs Prior PVI: 603 (32%) Years: One Year: Graft Occlusion Rate Amputation Rate J Vasc Surg, 2010 J Vasc Surg,

12 Deductibles Copayments 12

13 Femoral-Popliteal Disease Open Endo. (n= 183) (n= 198) p COSTS: Per Day of Patency Claudicants Limb Salvage 1 0 Patency (12 mos) 77% 65% < Assisted Patency (12 mos) 93% 80% <.01 Hospital Costs $12, 389 $6,739 <.001 Per day patency Per day patency East Carolina Brody School of Medicine J Vasc Surg, 2008 East Carolina Brody School of Medicine J Vasc Surg, 2008 National Inpatient Sample Patients: 563,143 Pornography You know when you see a patient who is best served by a bypass graft. COST INCREASE (%): PTA 60% BYPASS SURGERY 38% J Vasc Surg, 2011 Patients with TASC D and most Jacobellis v. Ohio, 1964 patients with TASC C lesions should undergo a bypass graft. Patients after multiple failed I shall not today attempt further endovascular to define procedures. should hard-core undergo a bypass graft. pornography. But I know it when I see it...and there s nothing wrong with doing a bypass graft in the endovascular era! Justice Potter Stewart 13

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