Safety and Efficacy of Distal Superficial Femoral Artery Puncture for Femoropopliteal Occlusive Lesions
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1 Safety and Efficacy of Distal Superficial Femoral Artery Puncture for Femoropopliteal Occlusive Lesions ~Result form the Multicenter RIVERside registry~ Tatsuya Nakama, Y Yamamoto, A Matsui, T Doijiri, M Fujihara, N Hayakawa, T Michinao, S Ozaki, Y Tsubakimoto, M Utsunomiya, D Kaomoi, Y Imoto, M Kimura, H Anzai, Y Ohno, M Sugihara, N Fujimura, K Suzuki, N Kaneko, Y Iwata, H Ando, K Urasawa, Y Yokoi and Y Shibata On behalf of REVERside registry investigators
2 Disclosure Speaker name: Tatsuya Nakama MD.... I have the following potential conflicts of interest to report: Consulting: Boston Scientific Japan, Century Medical Inc. Employment in industry: None Stockholder of a healthcare company: None Owner of a healthcare company: None Other(s): Honoraria recieved from Abbot Vascular, Asahi Intecc., Boston Scientific, COOK, Cordis Cardinal Health, Goodman, KANEKA, Lifeline, Medikit, Medtronic, Orbus Neichi, Terumo,
3 Backgrounds Retrograde approach is important technique in percutaneous endovascular revascularization for FPA occlusion. Popliteal artery puncture (PAP: URA-pan) is already established as a conventional retrograde approach. Kawarada O. et al. J Endovasc Ther. 2010; 17: Distal SFA puncture (DSFAP: OMOTE-pan) has been widely spread as an alternative retrograde access technique. A Schmidt et al. J Endovasc Ther. 2012; 19:23-29 Femoropopliteal artery: FPA, Superficial femoral artery: SFA,
4 Complications of DSFAP Retrograde access site complications, such as hematoma, re-bleeding, pseudoaneurysm and hemostatic difficulty were sometimes observed during daily clinical practice. Kenji O. et al. LINC2017 Pseudoaneurysm Thrombin injection required Fujihara M. et al. LINC2017 Frequent re-bleeding Covered stent deployment
5 Multicenter registry was planned Retrospective analysis for the clinical value of retrograde access technique in endovascular therapy for femoropopliteal occlusions
6 Purpose Distal SFA puncture (OMOTE-pan) To investigate the safety and efficacy of the DSFAP technique in EVT for FP occlusions.
7 Backgrounds Study type Retrospective, multicenter study (18 site) Study period January 2012 to July 2016 ( 30 months ) Number of patients 609 retrograde procedure for SFA occlusion Study patients Symptomatic PAD patients who underwent EVT for SFA occlusion using retrograde approach
8 RIVERside registry Retrospective analysis for the clinical value of retrograde access technique in endovascular therapy for femoropopliteal occlusions Tokeidai Memorial Hp. Fukuoka Wajiro Hp. Fukuoka University Hp. Japanese Red Cross Kyoto Daiichi Hp. Japanese Red Cross Kyoto Daini Hp. Kishiwada Tokushukai Hp. Miyazaki Medical Association Hp. Ota Memorial Hp. Yamato Seiwa Hp. Iwaki Kyoritsu General Hp. Kokuho Asahi Chuo Hp. Itabashi Chuo Medical Center Nagoya Kasukabe Chuo General Hp. Kyoritsu Hp. Tokyo Rosai Hp. Chiba University Hp. Tokyo Saiseikai Central Hp.
9 Methods 609 Patients underwent percutaneous FPA-CTOs recanalization with retrograde approach Trans-collateral approach (n=41) Tibial or peroneal puncture (n=51) Antero-lateral P3 puncture (n= 26) Popliteal puncture (PAP cohort) _ 142 patients Distal SFA puncture (DSFAP cohort) 349 patients Procedural success & complication rate
10 Baseline characteristics Overall (n= 491) PAP cohort (n= 142) DSFAP cohort (n= 349) P value General Status Age, years 73.2 ± ± ± Male, n (%) 350 (71.3) 247 (70.8) 103 (72.5) Ambulatory status on admission Independent gait, n (%) 354 (72.1) 101 (71.1) 253 (72.5) Walk with stick, n (%) 47 (9.6) 12 (8.5) 35 (10.0) Non-ambulatory status, n (%) 90 (18.3) 29 (20.4) 61 (17.5) Wheel chair use, n (%) 71 (14.5) 22 (15.5) 49 (69.0) Bed-ridden, n (%) 19 (3.9) 7 (4.9) 12 (3.4) Limbs status Critical limbs ischemia, n (%) 159 (32.4) 53 (37.3) 106 (30.4) With ischemic wounds, n (%) 114 (23.2) 34 (23.9) 80 (22.9) ABI before intervention 0.52 ± ± ± ABI after intervention 0.89 ± ± ±
11 Baseline characteristics Overall (n= 491) PAP cohort (n= 142) DSFAP cohort (n= 349) P value Risk factors Hypertension, n (%) 422 (85.9) 118 (83.1) 304 (87.1) Dyslipidemia, n (%) 310 (63.1) 88 (62.0) 222 (63.6) Diabetes mellitus, n (%) 273 (55.6) 87 (61.3) 186 (53.3) Smoking history, n (%) 232 (47.3) 72 (50.7) 160 (45.8) Regular hemodialysis, n (%) 99 (20.2) 31 (21.8) 68 (19.5) History of ischemic heart disease, n (%) 208 (42.4) 76 (53.5) 132 (37.8) History of cerebrovascular disease, n (%) 106 (21.6) 29 (20.4) 77 (22.1) Medication Aspirin, n (%) 407 (82.9) 122 (85.9) 285 (81.7) Clopidogrel, n (%) 353 (71.9) 105 (73.9) 248 (71.1) Cilostazol, n (%) 175 (35.6) 48 (33.8) 127 (36.4) DAPT, n (%) 427 (87.0) 124 (87.3) 303 (86.8) Anticoagulation therapy, n (%) 63 (12.8) 15 (23.8) 48 (13.8) DAPT + anticoagulation therapy, n (%) 52 (10.6) 13 (9.2) 39 (11.2) 0.528
12 Angiogram characteristics Overall (n= 491) PAP cohort (n= 142) DSFAP cohort (n= 349) P value Angiographic characteristics TASC D, n (%) 397 (80.9) 109 (76.8) 288 (82.5) De novo lesion, n (%) 462 (94.1) 134 (94.4) 328 (94.0) Lesion length, mm 248 ± ± ± Vessel calcification < None, n (%) 101 (20.6) 27 (19.0) 74 (21.2) Mild, n (%) 165 (33.6) 26 (18.3) 139 (39.8) Moderate, n (%) 93 (18.9) 33 (23.2) 60 (17.2) Severe, n (%) 132 (26.9) 56 (39.4) 76 (21.8) Moderate to severe calcification, n (%) 225 (45.8) 89 (62.7) 136 (39.0) < PACCS score < , n (%) 115 (23.4) 26 (18.3) 89 (25.5) 1, n (%) 109 (22.2) 17 (12.0) 92 (26.4) 2, n (%) 48 (9.8) 20 (14.1) 28 (8.0) 3, n (%) 74 (15.1) 25 (17.6) 49 (14.0) 4, n (%) 145 (29.5) 54 (38.0) 91 (26.1)
13 EVT procedures Overall (n= 491) PAP cohort (n= 142) DSFAP cohort (n= 349) P value Antegrade approach site Crossover, n (%) 302 (61.5) 71 (50.0) 231 (66.2) Sheathless technique for retro site, n (%) 366 (74.5) 68 (47.9) 298 (85.4) < Guidewire crossing technique < Retrograde direct cross (%) 81 (16.5) 38 (26.8) 43 (12.3) Kissing wire, n (%) 32 (6.5) 12 (8.5) 20 (5.7) Wire rendezvous, n (%) 320 (65.2) 66 (46.5) 254 (72.8) CART/ reverse CART, n (%) 51 (10.4) 23 (16.2) 28 (8.0) Retrograde access site hemostasis Tamponade with PTA balloon, n (%) 418 (85.1) 85 (59.9) 333 (95.4) < Size of PTA balloon, mm 4.87 ± ± ± Use of compression devices, n (%) 78 (15.9) 49 (34.5) 29 (8.0) < Thrombin injection required, n (%) 37 (7.5) 6 (4.2) 31 (8.9) Time to complete hemostasis, min 26.6 ± ± ± 6.7 <0.0001
14 Primary efficacy outcomes Procedural success rate (%) P= % 97.9% 98.9% All cohort POPA cohort DSFAP cohort (Overall) (URA-pan) (OMOTE-Pan) All cohort PAP cohort DSFAP cohort Retro puncture success rate 99.0% 100.0% 98.6%
15 Primary safety outcomes Incidence of overall complications (%) P= % 9.9% 9.7% 6 5 All cohort PAP cohort DSFAP cohort (Overall) (URA-pan) (OMOTE-Pan)
16 Puncture related complications Puncture 7 relataed complication rate % 6.0% 2 3.3% 4.9% 3.5% 4.0% 1 2.4% 1.4% 2.0% 0 All cohort PAP cohort DSFAP cohort Overall Antegrade Retrograde
17 Puncture related complications All 7 puncture site P= % 6.0% 2 3.3% 4.9% 3.5% 4.0% 1 2.4% 1.4% 2.0% 0 All cohort PAP cohort DSFAP cohort Overall Antegrade Retrograde
18 Puncture related complications Antegrade 7 puncture site P= % 6.0% 2 3.3% 4.9% 3.5% 4.0% 1 2.4% 1.4% 2.0% 0 All cohort PAP cohort DSFAP cohort Overall Antegrade Retrograde
19 Puncture related complications Retrograde 7 puncture site 6 5 P= % 6.0% 2 3.3% 4.9% 3.5% 4.0% 1 2.4% 1.4% 2.0% 0 All cohort PAP cohort DSFAP cohort Overall Antegrade Retrograde
20 Secondary outcomes Incidence of 30-days adverse event (%) 8 P= % 7.6% 5.6% 2 0 All cohort POPA cohort DSFAP cohort (Overall) (URA-pan) (OMOTE-Pan)
21 Summary of presentation Retrograde puncture success rate PAP: 100% vs. DSFAP: 99% Procedural success rate PAP: 98% vs. DSFAP: 99%
22 Summary of presentation Overall complication rate PAP: 9.9% vs. DSFAP: 9.7% Puncture related complication rate PAP: 4.9% vs. DSFAP: 6.0% Retrograde site complication rate PAP: 1.5% vs. DSFAP: 4.0% Included 1% blood transfusion
23 Conclusions Both retrograde access technique, PAP and DSFAP, were feasible and safe technique in percutaneous endovascular revascularization for complex FPA occlusions. Safety and efficacy of DSFAP, which was called OMOTE-pan in Japan, is not inferior compared to conventional PAP, which called URA-pan.
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