9/7/2018. Disclosures. CV and Limb Events in PAD. Challenges to Revascularization. Challenges. Answering the Challenge

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1 Disclosures State-of-the-Art Endovascular Lower Extremity Revascularization Promotional Speaker Jansen Pharmaceutical Promotional Speaker Amgen Pharmaceutical C. Michael Brown, MD, FACC al Cardiology Associate Professor WVU HVI Challenges to Revascularization CV and Limb Events in PAD Calcium Body habitus Infrapopliteal disease Inframalleolar disease Long segment occlusions Late recognition of disease severity Chronic kidney disease Distal embolization Re-occlusion Co-morbidities In the REACH (Reduction of Atherothrombosis for Continued Health) registry, PAD patients had a 21.1% annual risk of CV death, MI, stroke, or hospitalization for an atherothrombotic cause The risk of major adverse limb events (typically defined as major amputation or surgical intervention) varies from 2% to 10% annually depending on age, symptom classification, concomitant medical therapy, and prior revascularization procedures Challenges Answering the Challenge Rule of Quarters For CLI patients the clinical course over the year following diagnosis 25% improve 25% persist 25% amputation 25% mortality Following major amputation nearly 50% 1 yr mortality and 50% of survivors never ambulate CLI patients are often poor surgical candidates due to poor run-off, high operative risk, lack of sufficient conduit. Endovascular first is being utilized more frequently in treating CLI. Antegrade femoral approach fails to cross chronic occlusion in up to 20% of cases. Radial Access Tibial Access TAMI technique Trans-pedal access Pedal Arch Reconstruction Ultrasound guidance Re-entry devices 1

2 First described by Campeau in 1989 for Coronary Angiography First Coronary intervention1993 Opportunities Earlier ambulation Shorter length of stay Reduced resource and staff use Decreased hospital cost Increased patient satisfaction Anatomic advantages Carotid, subclavian, innominant, renal, mesenteric, celiac interventions Favorable angles, better support, coaxial vessel alignment. Prior iliac bifurcation stenting, stent grafts, iliac tortuosity and calcification, prior surgery. In the coronary world Translates to reduced bleeding and access site complications Decreased bleeding complications leads to reduced mortality RIVAL, RIFLE-STEACS and STEMI- RADIAL demonstrated morbidity and mortality benefit to radial access in STEMI patients An observational analysis of a non- selected cohort of nearly 350,000 patients from the British Cardiovascular Society database demonstrated radial access to be independently associated with reduced 30 day mortality in both ACS and non- ACS patients Percutaneous Radial Access for Peripheral Transluminal Angioplasty Percutaneous Radial Access for Peripheral Transluminal Angioplasty 2015 Coscas et al. reported in Journal of Vascular Sugery Results of 24 patients (38 lesions) with TASC A and B 22 Claudicants, 2 CLI Reasons for using radial access 12 with bilateral hostile groins, 4 bilateral infra-inguinal lesions 3 prior kissing iliac stents or bifurcated surgical aortic grafts 5 elective Results 1 radial access failure (brachial site utilized) Technical success in 91% 37 stents implanted 2 radial artery injuries All patients ambulated within 2 hours post procedure. No deaths Limitations Limitations Smaller diameter vessel Greater distance to target Lack of pushability Difficult imaging Limitations Greater patient and operator exposure Radial occlusion Catheter entrapment 2

3 Limitations Using ultrasound and the TAMI (Tibio-pedal Arterial Minimally Invasive) technique operators accessed and revascularized the lower extremity via tibiopedal arterial access only Retrospective, single center case series N=23; 83% Rutherford IV-VI Compared with 201 unmatched patient treated via CFA access Results 36 lesions treated, 25% above the knee Lesion success 95% (post treatment stenosis <30%) Average pre-stenosis 92.5%; average post-stenosis 12% No major complications 3

4 Walker reported results of 228 CLI patients in whom tibio-pedal approach was utilized to treat infrainguinal occlusions 95% successful access (217/228) 93% Successful crossing (199/217) Of those successfully crossed overall treatment success was 99% No bleeding complications One pedal occlusion Nakama et al studied consecutive patients with critical limb ischemia (n = 257) presenting with de novo infrapopliteal and pedal artery disease Patients were divided into 2 groups according to whether PAA was performed (n = 140) or not (n = 117). The rate of wound healing and time to wound healing were compared between these groups The rate of wound healing was significantly higher (57.5% vs. 37.3%, p = 0.003) and time to wound healing significantly shorter (211 days vs. 365 days; p = 0.008) in the PAA group. Nonambulatory status, target wound depth, and daily hemodialysis were revealed as predictors of delayed wound healing. PAA was performed as required. A inch guidewire was advanced into the occluded pedal artery with the support of a microcatheter. When the guidewire could not cross the occlusion, a bidirectional approach from both tibial arteries was established. If needed, novel retrograde access techniques such as metatarsal artery puncture or a transcollateral approach were used. After guidewire crossing, occluded pedal arteries were dilated with a 2.0-mm balloon for at least 3 min. All patients were followed up at 1 week; 1, 2, and 3 months; and then every 3 months up to 12 months after the procedure with ultrasound scanning and ABI measurements Wound care specialists individually followed patient s wounds 4

5 Conclusions Procedural success and complication rates. Procedurerelated complications occurred in 17 cases (6.6%). Limb-threating complications were observed in 3 cases (1.2%) Overall technical success rate of adjunctive PAA was acceptable (88.6%), and complete pedal artery revascularization was obtained in 64 cases (45.7%) Interrupting the natural progression of critical limb ischemia takes an aggressive multidisciplinary approach When lesion complexity and patient co-morbidity limit traditional revascularization techniques novel approaches should be considered to restore perfusion and avoid further tissue loss and possible amputation References References Walker CM, Mustapha J et al. Tibiopedal Access for Crossing Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study. Journal of Endovascular Therapy; 2016, Vol 23(6) Roundback, JH, Herman KC. Transpedal s for Critical Limb Ischemia. Vascular Disease Management. 2013: 10(8): E152-E158. Mustapha JA, Saab F et al. Tibio-Pedal Arterial Minimally Invasive Retrograde Revascularization in Patients with Advanced Peripheral Vascular Disease: The TAMI Technique, Original Case Series. Catheterization and Cardiovascular s. 83: (2014). Walker C. Pedal access in critical limb ischemia. J Cardiovasc Surg. 2014;55: Rogers JH, Laird JR. Overview of New Technologies for Lower Extremity Revascularization. Circulation; 2007;116: Bradbury AW, Adam dj, Bell J, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial. J. Vasc Surg Cassese S, Ndrepepa G, et al. Drug Coated Balloons for Revascularization of Infrapopliteal Arteries: A Meta- Analysis of Randomized Trials. JACC: Cardiovascular s Vol 9, No. 10. Micari A, Nerla R, et al. 2- Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease. JACC: Cardiovascular s. Vol. 10. No. 7, Giacoppo D, Cassese S, et al. Drug Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials. JACC: Cardiovascular s. Vol 9. No. 16, Anand S. Caron F. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease. The Compass Trial. JACC: Vol 71, No Alexander J. CO2 Angiography in Lower Extremity Arterial Disease. Endovascular Today. September Lustro F, Grotti S. Drug-Eluting Balloon in Peripheral fo rthe Superficial Artery; The Debate SFA Randomized Trial. JACC: Cardiovascular s. Vol. 6, No. 12, Truesdell A, et al. Transradial peripheral vascular intervention: challenges and opportunies. Interv. Cardiol (1), Nakama et al. Clinical Outcomes of Pedal Artery Angioplasty for Patients With Ischemic Wounds: Results From the Multicenter RENDEZVOUS Registry. JACC: Cardiovascular s. Jan Vol Waksman R, Pakala R, et al, Drug-Eluting Balloon: The Comeback Kid. Circulation: Cardiovascular s. 2009;2: Coscas R. et al. Percutaneous radial access for peripheral transluminal angioplasty. J Vasc Surg Feb; 61(2):