Maximally Invasive Vascular Surgery for the Treatment of Critical Limb Ischemia
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1 Maximally Invasive Vascular Surgery for the Treatment of Critical Limb Ischemia Traci A. Kimball, MD Department of Surgery Grand Rounds Septemember 13, 2010
2 Overview Defining Critical Limb Ischemia Epidemiology and Natural History Rationale Evidence Cost analysis Conclusions
3 [1] Definition [1] Critical Limb Ischemia (CLI) Most advanced form of peripheral arterial disease (PAD) Limb pain that occurs at rest and/or impending tissue loss (e.g. ulcers or gangrene) from lack of blood flow or a mismatch with tissue demand for oxygen 1. Hirsch, AT et.al. ACC/AHA Practice Guidelines for PAD.Circulation, 2006.
4 [1] Definition [1] History should be focused on distinguishing chronicity and global atherosclerotic disease burden Operative risk stratification Life expectancy determination Patient s s goals, quality of life and functional status. Physical [2]: Ankle-brachial index (ABI); Toe-pressures (i.e. diabetics, noncompressible artery); <30mmHG (rest pain), <40mmgHg (tissue loss) Segmental pressures; ankle <60mmHg (tissue loss), <40mmHg (rest pain) Pulse-volume Recordings (PVRs( PVRs); flat or barely pulsative 1. Hirsch, AT et.al. ACC/AHA Practice Guidelines for PAD.Circulation, Rutherford, RB et al. Reporting standards for CLI. JVS, 1997.
5 Fontaine Stage and Rutherford Categories [1] Universally accepted grading systems for PAD severity Provides patient stratification based on degree if ischemia and salvageability 1. Dormandy JA, Rutherford RB. TASC Working Group Management of PAD. JVS, 2000.
6 Rutherford Categories [1-2] 1. Dormandy JA, Rutherford RB. TASC Working Group. JVS, Beard, JD. Recommendations for the Management of CLI. Eur J Vasc Endovasc Surg, 1996.
7 Epidemiology new cases of CLI per annum in a European or North American population of 1 million [1] Predictor variables leading to a diagnosis of CLI: Diabetes 4X Smoking Smoking 3X Age >65 2X ABPI <0.7 2X ABPI < X Dyslipidemia 2X 1. Dormandy JA, Rutherford RB. TASC Working Group. JVS, 2006.
8 Natural History 1. Dormandy JA, Rutherford RB. TASC Working Group. JVS, 2006.
9 Define the Anatomy The Real Debate Anatomic considerations [TASC class] Define the Clinical Endpoint: Limb Specific? Amputation free survival, wound healing, patency rates Patient-specific? Overall survival, freedom from Major Adverse Cardiac Events (MACE), functional outcomes Defining the Patient
10 TASC II Classification 1. Dormandy JA, Rutherford RB. TASC Working Group Management of PAD. JVS, 2006.
11 BASIL Study [1] PRCT Bypass vs. Angioplasty for CLI UK Study, Aug 1999-July 2004 BSX arm= 228; BAP arm=224; infrainguinal dz. Longitudinal 3 year follow-up; 5 year (~50% lost) Intention to Treat Analysis all data Amputation-free survival Overall survival Morbidity, re-interventions, HRQOL, cost- effectiveness as secondary end-points Bradbury AW et al. BASIL Trial: ITT analysis. JVS, 2010.
12 BASIL Study Bradbury AW et al. BASIL Trial: ITT analysis. JVS, 2010.
13 BASIL Study Bradbury AW et al. BASIL Trial: ITT analysis. JVS, 2010.
14 BASIL Study Bradbury AW et al. BASIL Trial: ITT analysis. JVS, 2010.
15 Other arguments Primary and secondary patency rates [1 Endo (3 yr data): 48.6%, 62.9% Bypass (5 yr data): 63%, 71% Health-related Quality of Life [3] [1-2] 3 years of data, VAscuQOL,, SF-36, EuroQol No significant difference 1. Romiti, M et al. Metanalysis of infrapopliteal angioplasty for CLI. JVS, Albers M et al. Metanalysis of popliteal-to-distal vein bypass grafts for CLI. JVS, Forbes JF et al. BASIL Trial: HRQOL, resource utilization, costs. JVS, 2010
16 Retrospective review [1] Economics 381 femoropopliteal revascularizations (open v. endo) CLI subgroup analysis showed lost savings at 1 year in the endovascular arm due to re-interventions. BASIL [2] Amortized savings of $229 to $185 (p=0.71) Savings of $8469 initially with angioplasty, but after 1 year savings were $5521 and no longer significant 1. Stoner et al. JVS, Forbes JF et al. BASIL Trial: HRQOL, resource utilization, costs. JVS, 2010
17 Economics Medicare PAD population Report on costs [1] PAD-related Medicare Part A and B claims in % of the Medicare population $4.37 billion spent on PAD treatment, 2.3% total expenditures One-third PAD patients accumulated healthcare costs. 1. Hirsch AT, et al. Vascular Medicine, 2008.
18 Summary Yes to Bypass: Younger patients, with appropriate operative risk and acceptable anatomy who will live long enough to realize the benefits of the procedure No to Bypass: Favorable anatomy in the Aorto-iliac/fem iliac/fem-pop segments Inappropriate operative risk, extensive tissue loss where, no identifiable targets.
19 Thanks!
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