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Achieving Acute Success and Durable Results with Complete Total Occlusion?

Achieving Acute Success and Durable Results with Complete Total Occlusion?. Christopher J. Kwolek, MD FACS Harvard Medical School Division of Vascular and Endovascular Surgery Massachusetts General Hospital. Background.

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Achieving Acute Success and Durable Results with Complete Total Occlusion?

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  1. Achieving Acute Success and Durable Results with Complete Total Occlusion? Christopher J. Kwolek, MD FACS Harvard Medical School Division of Vascular and Endovascular Surgery Massachusetts General Hospital

  2. Background Peripheral arterial occlusive disease (PAOD) is associated with substantial morbidity and health care expediture Operative series have consistently demonstrated 5 year limb salvage rates of 80% or greater Complications may occur in up to 25% patients after peripheral arterial bypass surgery Morbidity may compromise functional outcomes as less than 50% patients report a return to “normal” by 6 months postoperatively

  3. Background • Increasing application of endovascular therapy to all territories of the arterial tree • Percutaneous endovascular infrainguinal interventions (PVI) have been proposed as first line therapy for PAOD • PVI : primary patency rates 12-90%, but secondary interventions are non-surgical • Enthusiasm for broadening PVI indications has continued to increase! Claudication? Limb Salvage?

  4. Peripheral Angioplasty 5 year patency Claudication 40% Limb Salvage 28% Stenosis 43% Occlusion 32% Good Runoff 47% Poor Runoff 28%

  5. THE FUTURE DEFINEDINFRAINGUINAL DISEASE • SFA occlusions - Traditional wisdom: The variety of endovascular interventions has produced poor results: PTA vs. PTA/Stent Trial • 221 patients, < 7cm SFA lesion • Angiographic failure at one year 40% • Patency @ 4 years  50% (Becquemin et al. SVS, June ‘02)

  6. Background Development of small diameter catheter systems (0.014/0.018) Flexible, self-expanding Nitinol stents Studies with longer follow-up performed over 10-15 yrs – outdated

  7. Mortality of patients with PVD 10 Yr Mortality Claudication 48% Rest Pain 80% Gangrene 95%

  8. Cannulation of Contralateral Iliac Artery

  9. Torque Device

  10. Technique Contralateral access Placement of a working sheath 6Fr Raabe or Balkan in the CFA or SFA Use of an .035” angled/straight glidewire with an angled or straight 4Fr/5FR catheter Try to stay intraluminal but frequently end up subintimal using the “loop” of the distal wire to advance REENTRY Retrograde popliteal/tibial approach

  11. Frontrunner XP Peripheral CTO • .039” distal tip size • 2.3mm jaw opening • 90 and 120cm lengths • Responsive torque • Shapeable distal tip • Blunt micro-dissection technology .039” XP compared to .035” guide wire

  12. Outback and Pioneer Catheter Enables rapid, safe, and reproducible re-entry of a guidewire from the subintimal space back into the true lumen of a peripheral vessel

  13. OutbackLTD Re-Entry Catheter • Deploy cannula in either “T” or “L” view • Advance wire • Retract needle • Remove device

  14. Technique Once intraluminal access is regained will often switch to a low profile balloon .018” saavy or .014” coronary balloons Sequentially dilate up to 5 or 6 mm Self-expanding nitinol stents for significant recoil, dissection with flow limiting lesion Plavix load and then continue for at least 6 weeks then switch to ASA alone Flexed views of the leg

  15. MGH Results 1) Mid-term results of femoropopliteal PTA 2) Contemporary series of patients 3) Influence of clinical variables on patency and limb salvage rates

  16. Methods Retrospective record review – 1/02 – 7/04 Native femoropopliteal disease Chronic LE ischemia Exclusion criteria: Acute critical limb ischemia Functionally unsalvageable limb Threatened bypass graft Mechanical thrombectomy/ thrombolysis

  17. Methods Demographic/ operative data Clinical presentation (Rutherford classification) 1-3 = Claudication 4 = Rest Pain 5-6 = Tissue Loss Lesion Anatomy (TASC classification) A = single stenosis < 3cm B = single stenosis/occlusion 3-5cm or multiple <3cm C = single stenosis/occlusion >5cm or multiple 3-5cm D = Complete SFA/POP occlusion

  18. Demographic and Clinical Factors

  19. Anatomic/Treatment Features Angiographic success 230 (97%) limbs

  20. Complications No deaths related to PTA 6 Significant complications 2 groin hematomas requiring transfusion 1 thromboembolus – thrombolysis 1 intubation from pulmonary edema 1 SFA rupture – FP bypass 1 device malfunction – FP bypass

  21. 42.4% 65.6% Primary Patency p=0.004

  22. Predictors of Primary Failure

  23. 92.7% 93.8% Assisted Patency p=0.31

  24. 89.8% 100% Limb Preservation p=0.007

  25. Predictors of Limb Loss

  26. 89.8% 94.4% 31.7% TASC C/D Lesions

  27. 60.1% 93.6% Survival p<0.0001

  28. Summary PTA of the femoropopliteal arterial segment can be performed with 97% technical success and a low peri-procedure morbidity Three year primary patency is 54%, assisted patency is 92% and limb salvage is 89% in CLI

  29. Summary Predictors of primary patency failure include CHF and TASC C/D lesions Predictors of assisted patency failure include age < 65 yrs, CHF and TASC C/D lesions Predictors of limb loss include Diabetes and CHF

  30. Conclusions Although primary patency rates remain low, excellent assisted patency and limb salvage can be achieved with close follow-up PTA should be considered as initial therapy regardless of Rutherford classification

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