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 Claudication40% Limb Salvage28% Stenosis43% Occlusion32% Good Runoff47% Poor Runoff28%

5. THE FUTURE DEFINED INFRAINGUINAL 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systems (0.014/0.018) Flexible, self-expanding Nitinol stents Studies with longer follow-up performed over 10-15 yrs – outdated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 Claudication48% Rest Pain80% Gangrene95%

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” 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 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 TotalClaudCLIp Value Limbs238128 (54%)110 (46%) Male Gender149 (63%)82 (64%)67 (61%)0.62 Average Age72yrs 0.23 Hypertension222 (93%)118 (92%)104 (95%)0.47 Heart Disease141 (59%)72 (56%)69 (63%)0.31 Diabetes115 (48%)40 (31%)75 (68%)<0.001 Renal Insufficiency68 (29%)25 (20%)43 (39%)0.002 Dialysis22 (9%)5 (4%)17 (15%)0.002 Current Smoker32 (13%)18 (14%)14 (13%)0.76 Previous Smoker163 (68%)91 (71%)72 (65%)0.35 Hyperlipidemia163 (68%)89 (70%)74 (67%)0.71 CHF44 (18%)15 (12%)29 (23%)0.004

19. Anatomic/Treatment Features TotalClaudCLIp Value Patients238128 (54%)110 (46%) TASC A26 (11%)20 (16%)6 (5%)0.01 TASC B102 (43%)54 (42%)48 (44%)0.82 TASC C98 (41%)48 (37%)50 (46%)0.21 TASC D12 (5%)6 (5%) 0.79 Total Occlusion91 (38%)41 (32%)50 (46%)0.03 Stent Placed53 (22%)34 (27%)19 (17%)0.11 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. p=0.004 Primary Patency 42.4% 65.6%

22. Predictors of Primary Failure VariableHazard Ratiop Value CHF1.9730.02 TASC C/D1.9590.02 Age <651.2590.49 Female Gender1.1900.49 Diabetes1.2960.32 Current Smoker1.2850.58 Hypertension1.3000.62 Dialysis1.4700.35 Critical Limb Ischemia1.4360.18 Occluded Lesion1.3440.29

23. p=0.31 93.8% Assisted Patency 92.7%

24. p=0.007 100% 89.8% Limb Preservation

25. Predictors of Limb Loss VariableHazard Ratiop Value CHF6.6560.02 TASC C/D3.7350.09 Age <650.3020.40 Female Gender2.7010.21 Diabetes11.9060.03 Current Smoker1.9980.62 Hypertension0.4370.35 Dialysis1.7000.66 Occluded Lesion0.2050.08

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

27. p<0.0001 93.6% 60.1% Survival

28. 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 Summary

29. 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 Summary

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