SFA lesion treatment: China experience. Wei Liang, MD
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1 SFA lesion treatment: China experience Wei Liang, MD
2 Disclosure I do not have any potential conflict of interest
3 Background PAD: 14% - 20% in adults Aorta & Iliac A: 30% Femoral & Pop A: 80-90% Tibial / peroneal A: 40-50% More than 80% of the lesions related SFA Harrison s Principles of Int Med
4 The challenge of SFA lesions
5 Treatment Choice? CX News: TASC guidelines set to recommend "endovascular first" for all lesions Saturday, 09 Apr :30 Endo or Bypass
6 Treatment Choice? We have recognized: TASC A&B are favored for Endo But, How about the TASC C & D?
7 Location and length TASC II 109 SFA stenting procedures (95 patients) Average treatment length 15.7 cm 36 M primary, primary-assisted, and secondary rates: 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients By Cox proportional hazards analysis: TASC D lesions (HR 5.5) significantly affected primary patency
8 J Vasc Surg 2008;48: The 12- and 24-month primary patency: TASCII C PTA/S 83% ± 6%, 80% ± 7% TASCII D PTA/S 54% ± 8%, 28% ±12% TASCII C+D AK-FPB 81% ± 6%, 75% ± 7% Endo-first for SFA TASC-II A,B,C lesions Bypass-first for TASC-II D lesions (unless in high-risk patients)
9 Treatment Choice? Considering the Experience/Cost Better education Better practice Less complications Better medical insurance More endo for SFA in China
10 Dose BMS have the meaning in SFA? Zone A Zone B Zone C Zone D Bend / Kink Compress / Slight curve Fixed Bend / Kink Lansky, A; Angiographic Analysis of Strut Fractures in the SIROCCO Trial. TCT 2004
11 PTA is not always perfect Before Stent After Stent
12 In the era of DCBs, SFA stents still have a place Medicare Part B claims indicate an SFA stent is used in NEARLY HALF of all SFA cases in U.S. SFA procedures. DCBs may not reduce the need for a stent: Calcific plaque resists balloon dilatation. Dissection: hold back intimal flap Recoil: persistent after prolonged PTA/DCB 1. Laird JR et al. J Am Coll Cardiol. 2015;66(21): Ansel, LINC Tepe, LINC LifeStent Solo Vascular Stent System [package insert]. Tempe, AZ: C.R. Bard, Inc.; Zilver PTX Drug-Eluting Peripheral Stent [package insert]. Limerick Ireland: Cook Ireland LTD; Medicare Part B claims indicate an SFA stent is used nearly half of the time. (PSPSF, 2013) 7. Fanelli F. Is there a role for DEB in calcified arteries? Presented at: LINC; January 25, 2013; Leipzig, Germany.
13 SFA stents: definitive therapy or useful adjunct SFA Stents are proven as a standalone therapy STUDY DEVICE A.L.L. PP FTLR 4EVER Pulsar cm 73.4% 85.2% PEACE Pulsar cm 79.5% 81.0% RESILIENT Lifestent 6.2 cm 81.3% 87.3% DURABILITY II EverFlex 8.9 cm 77.2% N/A SUPERB Supera 9.0 cm 84.7% N/A DURABILITY EverFlex 9.6 cm 72.2% 79.1% Stents complement DCB and are an alternative to DES DCB +/- Stent vs. DES Ability to spot stent rather than full metal burden associated with DES Provisional Stent choice based on lesion type Crush resistance in Ca +++ Low COF for dissection tacking
14 Primary Patency Properties of an ideal SFA stent Low Chronic Outward Force (COF) High multidirectional flexibility RRF (resistance to concentric compression) Sufficient Radial Resisitive Force (RRF) Sufficient Crush Resistance (CR) Accurate deployment Elongation/compression can impact patency CR (resistance to eccentric compression) SUPERB Study (Supera): Patency dependent on deployment accuracy 1 Source: SUPERB Study 12m data presented by Lawrence Garcia, MD at VIVA
15 Background: what is COF? COF = Chronic Outward Force Chronic force exerted by a nitinol stent on vessel wall COF related with restenosis COF depends on: Oversizing Stent material and design Irregularities in the lesion Source:IIB(P)
16 Lower COF Chronic Outward Force (COF) varies widely among SFA stents + sufficient crush resistance Source:IIB(P)
17 Lower COF appears to correlate with reduced area of stenosis 28 days FUP 90 days FUP Astron Pulsar 8.78 Astron Pulsar 6.9 Lifestent Lifestent Astron Pulsar (low COF) shows significantly smaller area stenosis than LifeStent Source: Presented by Funovic M. LINC 2017
18 Important considerations with low COF stents: Vessel preparation Good vessel prep addresses many key factors: Prepares the vessel with less/no overstretch May reduce need for provisional stent Preserves native vessel- less metal burden if shorter stented segment is achieved Prolonged inflation (180 sec) may assist dissection sealing Inflation times of 180 sec. improve immediate PTA results vs. a 30 sec. dilatation strategy Significantly fewer major dissections and a modest reduction of residual stenoses 1. N. Zorger et al. Peripheral Arterial Balloon Angioplasty: Effect of Short versus Long Balloon Inflation Times on the Morphologic Results. J Vasc Interv Radiol Adapted rom Blessing E. Presented at LINC 2017
19 BIOFLEX PEACE (interim) 4EVER (Pulsar- 18) TASC D "TASC D II" PEACE BERN "4F INTERVE NTION" Primary Patency/TLR (%) AV. Lesion Length (cm) Pulsar-18 Clinical Data 100% 25 90% 80% 20 70% 60% 15 50% 40% 10 30% 20% 10% 0% 5 0 Primary Patency TLR Av. Lesion length Pulsar SE Stent is clinically proven in several studies, demonstrating consistent outcomes even in longer lesion BIOFLEX PEACE (interim). Lichtenberg M. Presented at LINC EVER Bosiers M. JEVT 2013;20: ; PEACE Lichtenberg M. JEVT, 2014, 21: ; BERN registry Baumann F. JCS 2012:52;475-80; TASC D registrylichtenberg M. JCS 2013: 54; 433-9; "TASC D II" registry Lichtenberg M. Clin Med Insights 2014: 8; 37-42; 4F intervention" Sarkadi H, Eur J Vasc Endovasc Surg (2015) 49,
20 Evidence-based SFA algorithm: Focus BMS Pre-dilatation PTA DCB for 3' Severe Ca+ Thrombus? FLD/RS >30% FLD/RS>30%? YES BMS/ Debulking (Ca+) NO BMS Full/partial lesion coverage Adjunctive full lesion DCB? Mission accomplished Combination Therapy DCB + BMS
21 Our Experience cases SFA-POP TASCII C 9 (36%), D 16 (64%) Mean lesion length 250±106 mm Pulsar-18 stents: 1.7±0.7 /Case 273±126 mm/case
22 Outcomes Primary patency FTLR Primary patency(%) FTLR(%) Time(months) Time(months) 6 M 12M Primary Patency 88% 80% FTLR 92% 88% Patency: PSVI <2.5
23 Typical Case-1 Male, 66yrs Left R4 DM Retrograde Puncture Calcium
24 Typical Case-1 PTX Pulsar Pulsar mm Post 12M CTA
25 Typical Case-2 Male, 80yrs Right R5 DM Smoker Ca : LIA, CFA & SFA stent
26 Typical Case-2 Antegrade recanalizing R PFA L. Brachial A Access Passeo Post PTA
27 Typical Case-2 SFA CTO & Calcium
28 Typical Case-2 Recanalizing SFA Reconstruction SFA & PFA bifurcation Retrograde cross SFA CTO Retrograde Stenting SFA: Pulsar *2 Kissing stent: SFA & PFA Bifurcation
29 Conclusions The SFA lesion is a challenge in China Endovascular treatment becomes the first choice to treat SFA lesion BMS is needed for SFA lesion The low COF stent has the beneficial to treat complex SFA lesions
30 Better Endo, Better Life
31 SFA lesion treatment: China experience Wei Liang, MD
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