1. TOKUDA HOSPITAL SOFIA VASCULAR SURGERY AND ANGIOLOGY DEPARTMENT DR. A. DASKALOV, ASSOC. PROFF. V. CHERVENKOV

2. Prevalence of peripheral arterial occlusive disease (PAD): approximately 5-10% in general population 15-20% in persons over 70 years 70% of patients with PAD present with an obstructive lesion in superficial femoral artery (SFA) with a preference for the adductor canal in one third of these cases occlusions of SFA progress in a proximal direction as far as the origin of the deep femoral artery (DFA) in 20 % the common femoral artery (CFA) and proximal part of DFA are involved Bulgarian Endovascular Course 2011 2

3. MINIMAL INVASIVE THE MAIN GOAL OF CONTEMPORARY REVASCULARIZATION TECHNIQUES RESTORATIVE INTERVENTION RESTORING THE PATENCY OF THE ARTERY USING THE VESSEL WALL ITSELF AS A CONDUIT

4. Rationale for hybrid procedures Bilateral CIA occlusions Bilateral EIA stenoses 3-10 cm long not extending into the CFA Unilateral EIA stenosis extending into the CFA. Unilateral EIA occlusion that involves the origins of internal iliac and/or CFA. Heavily calcified unilateral EIA occlusion with or without involvement of origins of internal iliac and/or CFA. Diffuse disease involving the aorta and both iliaca areries. Diffuse multiple stenoses involving the unilateral CIA, EIA and CFA. Unilateral occlusions of both CIA and EIA. Bilateral occlusions of EIA 35% INVOLVEMENT OF CFA Multiple stenoses or occlusions totaling> 15 cm with or without heavy calcification Recurrent stenoses or occlusions that need treatment after two endovascular interventions Chronic total occlusions of CFA or SFA (>20 cm, involving the popliteal artery) Chronic total occlusion of popliteal artery and proximal trifurcation vessels 20% INVOLVEMENT OF CFA

5. Is still CFA a no-stent zone? A number of recent publications suggest that with improvement of stent technology the percutaneous approach may be an alternative to surgery for CFA atherosclerotic obstructions. Even though the indication for endovascular therapy has been enlarged, open repair of common femoral artery is still considered as the treatment of choice. TECCO randomized and controlled trial, set up to compare open and endovascular procedures for the treatment of CFA atherosclerotic lesions. Estimated Enrollment:120 Study Start Date: February 2011 Estimated Study Completion Date: February 2014

6. Retrospective single center study Procedural success -92,7% In-hospital complications -6,4% 1-year PP : restenosis < 50% -72,4% TLR rates 19,9% Need for stenting -36,9% Conclusion from the authors: the endovascular approach of CFA, even for complex lesions, may be a valid alternative to surgery. Randomized trials are needed to define the optimal revascularization strategy for patients with CFA atherosclerotic lesions.

7. BETTER LONG-TERM PATENCY NEEDED Restenosis greater than 50% observed beyond 18 months was excluded from the analysis because it was considered disease progression not related to the procedure. The 5-year primary patency rate appeared to be only about 50%. These longer-term results are inferior to those achieved with endarterectomy and patch angioplasty.

8. A complete follow-up (mean 4.2 years) was obtained in 111 patients (115 limbs. The 7-year PP, APP, and SP rates were 96%, 100%, and 100%, respectively; the 7-year rates of freedom from further revascularization and survival were 79% and 80%, respectively. Conclusion: Proponents of endovascular procedures as a routine alternative treatment option should bear this in mind! Surgery 2010;147:268-74

9. CFA-Surgical considerations Surgical approach to the CFA requires a short groin incision only. Blood flow into both the SFA (if patent) and the profunda femoris can be restored (isolated CFA lesion is rare) reliably and predictably, with endarterectomy and patch angioplasty. Placement of a metal stent device across the length of the CFA might compromise the profunda origin, and likely impede subsequent interventions at a later date.

10. Common femoral artery (CFA) endarterectomy - Femoro-crural angioplasty Fem-pop bypass - Inflow or outflow by endovascular means Remote endarterectomy of SFA Hybrid techniques in SFA

11. Remote endarterectomy of SFA (RSFAE) An alternative minimal invasive technique comprising both endovascular and surgical methods in treating the same lesion (simultaneous hybrid procedure) Enables revascularization of SFA, CFA and PFA (when needed) through a SINGLE GROIN INCISION

12. PROCEDURE RSFAE (Remote superficial femoral artery endarterectomy) Incision of CFA and the origin of SFA Remote endarterectomy is performed using ringstripper or Mollring cutter devices for “blind” desobliteration of the artery. After debulking of the intima core a stent is placed over the transection zone in order to prevent reocclusion or dissection. Profundoplasty can be done if needed. Arteriotomy is closed with or without patch.

13. Revascularization of long occlusion of left SFA Transsection zone Stent 7/40mm Transection zone

14. Revascularization of long occlusion of left SFA

15. Revascularization of occlusion of left SFA, CFA, PFA Initial CT angiogram:

17. Limitations of the method Aneurismal disease Diffuse sclerosis with absent dissection plane Extremely calcified vessels

18. Complications related to remote endarterectomy Rupture of SFA during dissection of intima core

19. Complications Distal embolization after performing dissection

20. Complications Inability to cross the transected area wth guidewire Performing retrograde transpopliteal or tibial access Transecting further the intima in order to obtain better possibility to cross the transection area with guidewire

21. REVAS TRIAL Randomized trial comparing remote endarterectomy and supragenicular bypass surgery for long occlusions of the superficial femoral artery MEDIUM-TERM RESULTS

22. Patency and survival Primary patency: for venous (n = 25) and prosthetic grafts (n = 30) at the 3-year follow-up, primary patency 65% and 56% versus 47% for RSFAE (n = 61);(p = 0.143)

23. Patency and survival Assisted primary patency 84% ( venous) and 56% ( PTFE) versus 63% for RSFAE (p = 0.052), and secondary patency 89% and 59% versus 69% for RSFAE (p = 0.046), respectively. Limb salvage was 97% after RSFAE and 95% after bypass surgery (p = 0.564).

24. Perioperative results Length of operation and blood loss were comparable between groups. Technical success was 92% in the RSFAE group versus 100% in the bypass group. Median hospital length of stay was significantly shorter for RSFAE: 4 days (range,1-21 days) versus 6 days (range, 3-28 days; p = 0.004).

25. Martin et al. presented a retrospective trial involving 133 patients, mean follow- up was 19 months, with a primary patency of 70% at 30 months by life-table analysis. Primary assisted patency was 76% and secondary-80%. Limb salvage was 94%. Knight et al. reported a prospective multi-centre trial with median follow-up of 17 (range 2–34) months. At 18-months the cumulative primary, primary- assisted and secondary patency rates were 60, 70 and 72%, respectively Previous trials and cohort studies

26. ADVANTAGES OF REMOTE ENDARTERECTOMY minimally invasive - single groin incision no prosthetic material no anastomoses local anesthesia severe co-morbidity shorter operating time shorter ischemic time shorter hospitalization time less wound related complications cost effectiveness

27. DISADVANTAGES The main drawback remains early (< 1 year) restenosis rate caused by neointimal hyperplasia. (REVAS study provides evidence that vessel size and duration of ischemic walking complaints before RSFAE are predictive values for restenosis after RSFAE). An aggressive approach by endovascular means is needed to obtain better primary assisted patency rates. Initial success rate 92%.

28. CONCLUSIONS RSFAE is a minimally invasive additive for treatment of long (TASC D) SFA obstructions, especially when CFA is involved, with comparable assisted primary and secondary patency rates compared to other surgical and endovascular revascularization techniques. The venous bypass remains the best solution for long occlusions of SFA, but only 45% of patients had a sufficient saphenous vein available. If the saphenous vein is not applicable, RSFAE is valuable procedure because it is less invasive and the usage of prosthetic graft material and expensive endovascular devices can be avoided.

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