PMID- 31113719 OWN - NLM STAT- MEDLINE DCOM- 20200127 LR - 20221207 IS - 1097-6809 (Electronic) IS - 0741-5214 (Linking) VI - 70 IP - 1 DP - 2019 Jul TI - Results of infrainguinal revascularization with bypass surgery using a heparin-bonded graft for disabling intermittent claudication due to femoropopliteal occlusive disease. PG - 166-174.e1 LID - S0741-5214(18)32571-0 [pii] LID - 10.1016/j.jvs.2018.10.106 [doi] AB - BACKGROUND: The purpose of this study was to analyze the results of infrainguinal revascularization for disabling intermittent claudication (IC) due to femoropopliteal occlusive disease using bypass graft (BPG) surgery with a heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft. METHODS: Between 2002 and 2016, we performed 1400 BPGs with HB-ePTFE interventions in patients with femoropopliteal occlusive disease, of which IC was an indication in 485 (34.6%) patients. Early major end points were in-hospital mortality and major complications; late major end points were primary patency, freedom from redo bypass, freedom from progression to critical limb ischemia, and freedom from above-knee amputation or prosthetic graft infection. RESULTS: We performed 200 (41.2%) above-knee BPGs and 231 (47.6%) below-knee BPGs; 54 (11.1%) BPGs targeted a tibial artery. In-hospital death occurred in two (0.4%) patients. Overall, the major complication rate was 4.3%. The median duration of follow-up was 33 months (range, 1-150 months; interquartile range [IQR], 14-62.8 months); the cumulative follow-up index for survival was 0.75 +/- 0.25. During the follow-up, 56 (11.6%) patients died. Estimated primary patency of the BPG was 86.1% +/- 1.6% (95% confidence interval [CI], 82.7-88.9) at 12 months, 68.4% +/- 2.4% (95% CI, 63.5-72.9) at 36 months, and 57.7% +/- 2.9% (95% CI, 52.0-63.2) at 60 months. On multivariate analysis, runoff status (no or one vessel), site of the distal anastomosis (below the knee), and postoperative medical treatment (oral anticoagulants) impaired primary patency. Estimated freedom from redo bypass was 96.1% +/- 0.9% (95% CI, 93.9-97.5) at 12 months, 84.8% +/- 1.9% (95% CI, 80.7-88.2) at 36 months, and 76.4% +/- 2.6% (95% CI, 71.0-81.1) at 60 months. Both the runoff status (no or one vessel) and the diameter of the graft (6 mm) were significantly associated with the need for redo bypass. Freedom from progression to critical limb ischemia was 86.1% +/- 2.2% (95% CI, 81.2-89.9) at 60 months. During the follow-up, there were 20 (4.1%) above-knee amputations, which occurred at a median of 33 months (range, 2-107 months; IQR, 14-63 months) after the indexed BPG intervention. Prosthetic graft infection occurred in seven (1.4%) patients, with a median delay from index procedure to presentation with graft infection of 33 months (range, 1-72 months; IQR, 14-62.5 months), resulting in a freedom from prosthetic graft infection rate of 98.2% +/- 2% (95% CI, 95.8-99.2) at 60 months. CONCLUSIONS: In patients suffering from lifestyle-disabling IC with long or complex occlusive lesions of the femoropopliteal segment, open BPG surgery with Hb-ePTFE graft had an acceptably low mortality rate. A poor runoff status was a significant predictor of loss of graft patency, especially after a below-knee anastomosis, as was the need for redo bypass. Dual antiplatelet therapy had significantly better results against follow-up thrombosis, and 8-mm grafts showed better freedom from redo bypass compared with 6-mm grafts. CI - Copyright (c) 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. FAU - Piffaretti, Gabriele AU - Piffaretti G AD - Vascular Surgery, Department of Medicine and Surgery, ASST Settelaghi University Teaching Hospital, University of Insubria School of Medicine, Varese, Italy. Electronic address: gabriele.piffaretti@uninsubria.it. FAU - Dorigo, Walter AU - Dorigo W AD - Vascular Surgery, Department of Cardiothoracic and Vascular Surgery, Careggi University Teaching Hospital, University of Florence School of Medicine, Florence, Italy. FAU - Ottavi, Paolo AU - Ottavi P AD - Vascular Surgery, Cardiothoracic and Vascular Department, Santa Maria Hospital, Terni, Italy. FAU - Pulli, Raffaele AU - Pulli R AD - Vascular Surgery, Department of Cardiothoracic Surgery, University of Bari School of Medicine, Bari, Italy. FAU - Castelli, Patrizio AU - Castelli P AD - Vascular Surgery, Department of Medicine and Surgery, ASST Settelaghi University Teaching Hospital, University of Insubria School of Medicine, Varese, Italy. FAU - Pratesi, Carlo AU - Pratesi C AD - Vascular Surgery, Department of Medicine and Surgery, ASST Settelaghi University Teaching Hospital, University of Insubria School of Medicine, Varese, Italy. CN - PROPATEN Italian Registry Group LA - eng PT - Journal Article PT - Multicenter Study DEP - 20190518 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 RN - 0 (Anticoagulants) RN - 0 (Coated Materials, Biocompatible) RN - 0 (Platelet Aggregation Inhibitors) RN - 9002-84-0 (Polytetrafluoroethylene) RN - 9005-49-6 (Heparin) SB - IM CIN - J Vasc Surg. 2020 Jan;71(1):350-351. PMID: 31864654 CIN - J Vasc Surg. 2020 Jan;71(1):351-352. PMID: 31864656 MH - Aged MH - Aged, 80 and over MH - Amputation, Surgical MH - Anticoagulants/*administration & dosage/adverse effects MH - *Blood Vessel Prosthesis MH - Blood Vessel Prosthesis Implantation/adverse effects/*instrumentation/mortality MH - *Coated Materials, Biocompatible MH - Female MH - Femoral Artery/diagnostic imaging/physiopathology/*surgery MH - Heparin/*administration & dosage/adverse effects MH - Hospital Mortality MH - Humans MH - Intermittent Claudication/diagnostic imaging/mortality/physiopathology/*surgery MH - Italy MH - Limb Salvage MH - Male MH - Peripheral Arterial Disease/diagnostic imaging/mortality/physiopathology/*surgery MH - Platelet Aggregation Inhibitors/therapeutic use MH - Polytetrafluoroethylene MH - Popliteal Artery/diagnostic imaging/physiopathology/*surgery MH - Postoperative Complications/mortality/therapy MH - Progression-Free Survival MH - Prosthesis Design MH - Registries MH - Retrospective Studies MH - Risk Factors MH - Time Factors MH - Vascular Patency OTO - NOTNLM OT - Femoropopliteal bypass OT - Heparin-bonded expanded polytetrafluorethylene graft OT - Intermittent claudication FIR - Pratesi, Carlo IR - Pratesi C FIR - Dorigo, Walter IR - Dorigo W FIR - Innocenti, Alessandro Alessi IR - Innocenti AA FIR - Giacomelli, Elena IR - Giacomelli E FIR - Fargion, Aaron IR - Fargion A FIR - De Blasis, Giovanni IR - De Blasis G FIR - Scalisi, Luciano IR - Scalisi L FIR - Monaca, Vincenzo IR - Monaca V FIR - Battaglia, Giuseppe IR - Battaglia G FIR - Dorrucci, Vittorio IR - Dorrucci V FIR - Vecchiati, Enrico IR - Vecchiati E FIR - Casali, Giovanni IR - Casali G FIR - Ferilli, Fiore IR - Ferilli F FIR - Ottavi, Paolo IR - Ottavi P FIR - Micheli, Raimondo IR - Micheli R FIR - Castelli, Patrizio IR - Castelli P FIR - Piffaretti, Gabriele IR - Piffaretti G FIR - Tozzi, Matteo IR - Tozzi M EDAT- 2019/05/23 06:00 MHDA- 2020/01/28 06:00 CRDT- 2019/05/23 06:00 PHST- 2018/04/24 00:00 [received] PHST- 2018/10/02 00:00 [accepted] PHST- 2019/05/23 06:00 [pubmed] PHST- 2020/01/28 06:00 [medline] PHST- 2019/05/23 06:00 [entrez] AID - S0741-5214(18)32571-0 [pii] AID - 10.1016/j.jvs.2018.10.106 [doi] PST - ppublish SO - J Vasc Surg. 2019 Jul;70(1):166-174.e1. doi: 10.1016/j.jvs.2018.10.106. Epub 2019 May 18.