4/8/19 BTK Intervention: Approach, Technique and Outcomes Venita Chandra, MD Clinical Associate Professor of Surgery Division of Vascular Surgery Stanford Medical School, Stanford, CA UCSF Vascular Symposium San Francisco April 5 th , 2019 STANFORD Vascular Surgery Disclosures • Abbott Medical Advisory Board Member • Medtronic- consultant • Cook Medical - consultant STANFORD Vascular Surgery 1
4/8/19 BTK Intervention: Approach, Technique and Outcomes Venita Chandra, MD Clinical Associate Professor of Surgery Division of Vascular Surgery Stanford Medical School, Stanford, CA UCSF Vascular Symposium San Francisco April 5 th , 2019 STANFORD Vascular Surgery Patterns of CLI AI 3% Fem 4% All AI + Segments Fem 1% 5% Pop/Tib 54% Fem + Rueda et. Pop/Tib al. JVS 30% 2008:47(5) STANFORD Vascular Surgery 2
4/8/19 The Doctors Dilemma with CLI patients “ I marvel that society would pay a surgeon a fortune to remove a person ’ s leg, but nothing to save it! ” -Ge Georg rge Bern rnard rd Sha haw- Th The Do Doctor ’ s Dil Dilemma STANFORD Vascular Surgery 5 BTK Revascularization Challenges • Long, complex, often calcified nature of lesions 1 • Often associated with multilevel disease, thus success is inflow- and outflow- dependent 2 • High restenosis rate 3 • Limb salvage poorly correlated to primary patency 3 • Not a lot of validated treatment algorithms • Requires application of multiple tools and techniques • Outcomes related to multiple anatomic and physiologic parameter STANFORD 1. Liistro F, et al. Circ 128:615-21 (2013). 2. Norgren L, et al. J Vasc Surg 45:S5-67 (2007). 3. Kudo T, et al. J Vasc Surg 41:423-35 (2005). Vascular Surgery 3
4/8/19 My BTK/CLI Goals of Therapy Goals of therapy for CLI (Rutherford 4–6) with infra- popliteal arterial disease include: 1) Relieving pain 2) Healing ulcerations 3) Preventing major amputation 4) Improving patient’s QOL 5) Prolonging survival STANFORD Vascular Surgery 7 Angiosome based approach STANFORD Vascular Surgery 8 4
4/8/19 What Do We Know?- Angiosomes Higher healing AND limb salvage rates after DIRECT distal bypass STANFORD Neville RF, Attinger CE, Bulan EJ, et al. Revascularization of a specific angiosome for limb salvage: does the target Vascular Surgery artery matter? Ann Vasc Surg 2009;23:367—73. Angiosomes: Endovascular Approach 250 patients • • 12 month ulcer healing: Direct: 69% • • Indirect: 47% p=0.021 • • Faster ulcer healing in Direct group Söderström, J Vasc Surg 2013 STANFORD Vascular Surgery 10 5
4/8/19 What About Pedal Flow? STANFORD Vascular Surgery Palena LM, Manzi M. Endovasc Ther. 2014. Dec;21 (6) 775-8 Intact pedal arch and pedal • arch angioplasty associated with improved AFS and limb salvage STANFORD Vascular Surgery 6
4/8/19 Endovascular Strategy • Treat all lesions to obtain in-line flow to the foot/affected areas • Choice of BTK revascularization depends on patients anatomy/symptoms • Angiosome concept • Pedal arch anatomy • Treatment involves: STANFORD Vascular Surgery TOOLS • Access • Support catheters • Wires • Balloons • Other adjunctive devices/technologies • Crossing technologies • Atherectomy • Reentry devices • Stenting • Drug eluting technologies • Etc. STANFORD Vascular Surgery 7
4/8/19 Access • Various Approaches • Up and Over • Antegrade • Retrograde STANFORD Vascular Surgery My BTK Approach • Longest sheath possible • Liberal use of vasodilators • Heparinization • Ultrasound and fluoro- guided retro access FEET HEAD STANFORD Vascular Surgery 8
4/8/19 Tools My Workhorse Products Wires Catheters Balloons Cook Abbott Abbott CXI .018” + .035” Command .014”/.018” Armada 14 Combo Abbott Terumo Corsair Catheter Armada 14 XT Glidewire Advantage .014” “Crossing Balloon” V18 Wire Cook Cook LP Hydro ST .014” 14 and 18 CTO wires STANFORD Vascular Surgery Technique/Tips • Remember goal : pulsatile flow to foot/affected area • Look for the BLUSH • Avoid subintimal • Sometimes collaterals are just as big as some native tibials • If I can’t get inline antegrade, try via collateral or pedal loop • Increasing interest in optimizing pedal loop • Ok to come back another day • Remember open bypass works GREAT STANFORD Vascular Surgery 9
4/8/19 BTK Case STANFORD Vascular Surgery BTK Case AT TPT wire wire STANFORD Vascular Surgery 10
4/8/19 BTK Outcomes • Heterogeneous nature of existing • Numerous treatment modalities data challenges interpretation • POBA • Atherectomy • Patient populations • DCB • Lesion types • BMS • Definitions • DES • Follow-up (e.g. wound care) STANFORD Vascular Surgery • Retrospective study of 106 CLTI pts who undergo endo revasc • 50% BTK STANFORD Vascular Surgery 11
4/8/19 • Wound healing 45% at 12 months • Sustained limb salvage of 87% • Severity of tissue loss (ie R6) associated with reduced primary patency, limb salvage and AFS STANFORD Vascular Surgery • 30 day outcomes looking at problem of “early technical failure” of EVT in BTK • Low dissection (6.4%) • Provisional Stenting: 9.9% • Amputation rates between 1.5% for DES and 4.4% with PTA • Procedural success rates of 91.2% (PTA) and 98.6% (BMS) STANFORD Vascular Surgery 12
4/8/19 Limb Salvage 2° Patency 1° Patency STANFORD Vascular Surgery What Do We Know?- CLI Treatment Results 1 month 6 months 1 year 2 years 3 years Primary Patency PTA 77.4 ± 4.1 65.0 ± 7.0 58.1 ± 4.6 51.3 ± 6.6 48.6 ± 8.0 Bypass 93.3 ± 1.1 85.8 ± 2.1 81.5 ± 2.0 76.8 ± 2.3 72.3 ± 2.7 P <0.5 <0.5 <0.5 <0.5 <0.5 Secondary Patency PTA 83.3 ± 1.4 73.8 ± 7.1 68.2 ± 5.9 63.5 ± 8.1 62.9 ± 11.0 Bypass 94.9 ± 1.0 89.3 ± 1.6 85.9 ± 1.9 81.6 ± 2.3 76.7 ± 2.9 P <0.5 <0.5 <0.5 Limb Salvage PTA 93.4 ± 2.3 88.2 ± 4.4 86.0 ± 2.7 83.8 ± 3.3 82.4 ± 3.4 Bypass 95.1 ± 1.2 90.9 ± 1.9 88.5 ± 2.2 85.2 ± 2.5 82.3 ± 3.1 STANFORD Romiti M, et. Al. Meta-Analysis of Infrapopliteal Angioplasty for Chronic Critical Limb Ischemia. JVS Vol 47, Issue 5, Vascular Surgery May 2008. 13
4/8/19 What Do We Know?- CLI Treatment Results 1 month 6 months 1 year 2 years 3 years Primary Patency PTA 77.4 ± 4.1 65.0 ± 7.0 58.1 ± 4.6 51.3 ± 6.6 48.6 ± 8.0 Bypass 93.3 ± 1.1 85.8 ± 2.1 81.5 ± 2.0 76.8 ± 2.3 72.3 ± 2.7 P <0.5 <0.5 <0.5 <0.5 <0.5 Secondary Patency PTA 83.3 ± 1.4 73.8 ± 7.1 68.2 ± 5.9 63.5 ± 8.1 62.9 ± 11.0 Bypass 94.9 ± 1.0 89.3 ± 1.6 85.9 ± 1.9 81.6 ± 2.3 76.7 ± 2.9 P <0.5 <0.5 <0.5 Limb Salvage PTA 93.4 ± 2.3 88.2 ± 4.4 86.0 ± 2.7 83.8 ± 3.3 82.4 ± 3.4 Bypass 95.1 ± 1.2 90.9 ± 1.9 88.5 ± 2.2 85.2 ± 2.5 82.3 ± 3.1 STANFORD Romiti M, et. Al. Meta-Analysis of Infrapopliteal Angioplasty for Chronic Critical Limb Ischemia. JVS Vol 47, Issue 5, Vascular Surgery May 2008. PTA Outcomes in BTK IN.PACT Lejay 1 Romiti 2 BASIL 3 ACHILLES 4 DEEP 5 BIOLUX P-II 6 PTA Meta- PTA Meta- Surgery DES v PTA DCB v PTA DCB v PTA analysis analysis v PTA Subjects 3164 2557 224 (PTA) 101 (PTA) 119 (PTA) 36 (PTA) 1° Patency (12-mo) 60.0% 58.1% 57.1%† Restenosis (12-mo) 41.9%† 45.6% TLR (12-mo) 16.5% 13.1% 30.6% FF-TLR (12-mo) Amputation (12-mo) 20.0% 3.6% 25.7% Limb Salvage (12-mo) 85.0% 86.0% 71.0% 3 1. Lejay A, et al. Acta Chir Belg 110:684-93 (2010). 2. Romiti M, et al. J Vasc Surg 47:975-81 (2008). 3. Adam D, et al. Lancet 366:1925-34 (2005); Amputation-free survival presented in 12-mo Limb Salvage as 71.0%. STANFORD 4. Scheinert D, et al. JACC 60:2290-5 (2012). Vascular Surgery 5. Zeller T, et al. JACC 64:1568-76 (2014). 6. Zeller T, et al. JACC Cardiovasc Interv 8:1614-22 (2015). 14
4/8/19 PTA Outcomes in BTK IN.PACT Lejay 1 Romiti 2 BASIL 3 ACHILLES 4 DEEP 5 BIOLUX P-II 6 PTA Meta- PTA Meta- Surgery DES v PTA DCB v PTA DCB v PTA analysis analysis v PTA Subjects 3164 2557 224 (PTA) 101 (PTA) 119 (PTA) 36 (PTA) 1° Patency (12-mo) 60.0% 58.1% 57.1%† Restenosis (12-mo) 41.9%† 45.6% TLR (12-mo) 16.5% 13.1% 30.6% FF-TLR (12-mo) Amputation (12-mo) 20.0% 3.6% 25.7% Limb Salvage (12-mo) 85.0% 86.0% 71.0% 3 • Variability in endpoints 1. Lejay A, et al. Acta Chir Belg 110:684-93 (2010). 2. Romiti M, et al. J Vasc Surg 47:975-81 (2008). • Low patency 3. Adam D, et al. Lancet 366:1925-34 (2005); Amputation-free survival presented in 12-mo Limb Salvage as 71.0%. STANFORD • High restenosis 4. Scheinert D, et al. JACC 60:2290-5 (2012). • Variable amputation/limb salvage rates Vascular Surgery 5. Zeller T, et al. JACC 64:1568-76 (2014). 6. Zeller T, et al. JACC Cardiovasc Interv 8:1614-22 (2015). BTK-Atherectomy Outcomes CALCIUM 360 1 DEFINITIVE LE (Infrapop) 2 OA+PTA v PTA DA Subjects 25 (OA+PTA) 145 Bail-out Stent 6.9% (2/29) 1.6% (3/189) MAE (12-mo) 6.7% (1/15)† FF MAE (12-mo) 79.6% 1° Efficacy (12-mo) 93.1% 84.0% Acute residual stenosis ≤ 30% w/o bail-out 1° Efficacy Definition Patency = PSVR < 2.4 stenting or dissection (C through F) TLR (12-mo) 6.7% (1/15) FF-TLR (12-mo) 91.2% Amputation (12-mo) 0% Limb Salvage (12-mo) 97.1% (141/145) STANFORD 1. Shammas NW, et al. J Endovasc Terh 19:480-8 (2012). Vascular Surgery 2. Rastan A, et al. J Endovasc Ther 22:839-46 (2015). 15
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