PMID- 35253348 OWN - NLM STAT- MEDLINE DCOM- 20220429 LR - 20221207 IS - 1522-726X (Electronic) IS - 1522-1946 (Print) IS - 1522-1946 (Linking) VI - 99 IP - 5 DP - 2022 Apr TI - Individual patient data meta-analysis of patients treated with a heparin-bonded Viabahn in the femoropopliteal artery for chronic limb-threatening ischemia. PG - 1714-1722 LID - 10.1002/ccd.30152 [doi] AB - OBJECTIVES: The aim of the study was to analyze available data on patients treated for chronic limb-threatening ischemia (CLTI) with the heparin-bonded Viabahn endoprosthesis. BACKGROUND: The patency of self-expanding covered stents in patients with complex femoropopliteal lesions is encouraging. However, data were mostly derived in patients with intermittent claudication. Patients with CLTI often have more advanced disease and worse outcome. METHODS: After the abstract screening, full-text papers were checked. Authors were approached to consider joining the consortium. Data were sent anonymously, databases were merged and an individual patient data meta-analysis was performed. Kaplan-Meier curves were used to calculate the freedom from amputations, the amputation-free survival, and patency rates. RESULTS: Seven studies were enrolled, representing 161 limbs that were treated for CLTI. Median lesion length was 28.0 cm (interquartile range 25.0-33.0 cm) and 82.7% were chronic total occlusions. The technical success rate was 98.1% and the 30-day mortality 1.9%. Through 2-year follow-up, the freedom-from-major-amputations was 99.3%, with an amputation-free survival of 78.8%. The freedom-from-loss-of primary, primary-assisted, and secondary patency was 70.4%, 71.8%, and 88.2%, respectively, at 1-year and 59.5%, 62.7%, and 86.1% at 2-year follow-up, respectively. The reintervention-free survival was 62.2% at a 2-year follow-up. CONCLUSIONS: Treatment of femoropopliteal disease in CLTI patients with the use of the heparin-bonded Viabahn is safe and effective with favorable clinical outcomes and low amputation rates. Reinterventions are needed in a subset of the population to maintain endoprosthesis patency. Close follow-up using duplex is recommended to detect potential edge stenosis, allowing treatment before device occlusion. CI - (c) 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC. FAU - Groot Jebbink, Erik AU - Groot Jebbink E AUID- ORCID: 0000-0001-7041-8603 AD - Department of Surgery, Rijnstate, Arnhem, The Netherlands. AD - Multi-Modality Medical Imaging Group, TechMed Center, University of Twente, Enschede, The Netherlands. FAU - van Wijck, Iris AU - van Wijck I AD - Department of Surgery, Rijnstate, Arnhem, The Netherlands. FAU - Holewijn, Suzanne AU - Holewijn S AD - Department of Surgery, Rijnstate, Arnhem, The Netherlands. FAU - Iida, Osamu AU - Iida O AUID- ORCID: 0000-0001-6829-7304 AD - Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan. FAU - Spinelli, Domenico AU - Spinelli D AD - Department of Biomedical and Dental Sciences and Morphological and Functional Imaging, University of Messina, Messina, Italy. FAU - Saxon, Richard R AU - Saxon RR AD - Interventional Radiology, San Diego Medical Imaging Group, Inc., San Diego, USA. FAU - Zeller, Thomas AU - Zeller T AUID- ORCID: 0000-0003-2704-3871 AD - Department Angiology, Universitats-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. FAU - Okhi, Takao AU - Okhi T AD - Department of Vascular Surgery, Jikei University School of Medicine, Tokyo, Japan. FAU - Bosiers, Marc AU - Bosiers M AD - Foundation for Cardiovascular Research and Education, Munster, Germany. FAU - Reijnen, Michel M P J AU - Reijnen MMPJ AUID- ORCID: 0000-0002-5021-1768 AD - Department of Surgery, Rijnstate, Arnhem, The Netherlands. AD - Multi-Modality Medical Imaging Group, TechMed Center, University of Twente, Enschede, The Netherlands. LA - eng GR - W. L. Gore and Associates/ PT - Journal Article PT - Meta-Analysis DEP - 20220307 PL - United States TA - Catheter Cardiovasc Interv JT - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JID - 100884139 RN - 9005-49-6 (Heparin) SB - IM MH - Amputation, Surgical MH - Blood Vessel Prosthesis MH - *Blood Vessel Prosthesis Implantation MH - Chronic Limb-Threatening Ischemia MH - Femoral Artery MH - Heparin/adverse effects MH - Humans MH - Ischemia/diagnostic imaging/etiology/therapy MH - Limb Salvage MH - *Peripheral Arterial Disease/diagnostic imaging/therapy MH - Popliteal Artery MH - Prosthesis Design MH - Treatment Outcome MH - Vascular Patency PMC - PMC9540662 OTO - NOTNLM OT - amputation OT - chronic limb-threatening ischemia OT - covered stent OT - critical limb ischemia OT - endoprosthesis OT - femoropopliteal OT - heparin-bonded Viabahn COIS- This study was funded by an unrestricted grant from W. L. Gore and Associates. Gore had no involvement in the study design or collection, analysis, and interpretation of data. Gore was not involved in the decision to submit the manuscript for publication. Richard R. Saxon, Osamu Iida, and Michel M. P. J. Reijnen are consultants for W.L. Gore and Associates and Michel M. P. J. Reijnen have received research funding from W. L. Gore and Associates. EDAT- 2022/03/08 06:00 MHDA- 2022/04/30 06:00 PMCR- 2022/10/07 CRDT- 2022/03/07 06:13 PHST- 2022/02/15 00:00 [revised] PHST- 2021/11/05 00:00 [received] PHST- 2022/02/21 00:00 [accepted] PHST- 2022/03/08 06:00 [pubmed] PHST- 2022/04/30 06:00 [medline] PHST- 2022/03/07 06:13 [entrez] PHST- 2022/10/07 00:00 [pmc-release] AID - CCD30152 [pii] AID - 10.1002/ccd.30152 [doi] PST - ppublish SO - Catheter Cardiovasc Interv. 2022 Apr;99(5):1714-1722. doi: 10.1002/ccd.30152. Epub 2022 Mar 7.