PMID- 38056700 OWN - NLM STAT- MEDLINE DCOM- 20240325 LR - 20240325 IS - 1097-6809 (Electronic) IS - 0741-5214 (Linking) VI - 79 IP - 4 DP - 2024 Apr TI - Investigator attitudes on equipoise and practice patterns in the BEST-CLI trial. PG - 865-874 LID - S0741-5214(23)02304-2 [pii] LID - 10.1016/j.jvs.2023.11.045 [doi] AB - OBJECTIVES: There has been significant variability in practice patterns and equipoise regarding treatment approach for chronic limb-threatening ischemia (CLTI). We aimed to assess treatment preferences of Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) investigators prior to and following the trial. METHODS: An electronic 60-question survey was sent to 1180 BEST-CLI investigators in 2022, after trial conclusion and before announcement of results. Investigators' preferences were assessed across clinical scenarios for both open (OPEN) and endovascular (ENDO) revascularization strategies. Vascular surgeon (VS) surgical and ENDO preferences were compared with a 2010 survey administered to prospective investigators before trial funding. RESULTS: For the 2022 survey, the response rate was 20.2% and was comprised of VSs (76.3%), interventional cardiologists (11.4%) and interventional radiologists (11.6%). The majority (72.6%) were in academic practice and 39.1% were in practice for >20 years. During initial CLTI work-up, 65.8%, 42.6%, and 55.9% of respondents always or usually ordered an arterial duplex, computed tomography angiography, and vein mapping, respectively. The most common practice distribution between ENDO and OPEN procedures was 70/30. Postoperatively, a majority reported performing routine duplex surveillance of vein bypass (99%), prosthetic bypass (81.9%), and ENDO interventions (86%). A minority reported always or usually using the wound, ischemia, and foot infection (WIfI) criteria (25.8%), GLASS (8.3%), and a risk calculator (14.8%). More than one-half (52.9%) agreed that the statement "no bridges are burned with an ENDO-first approach" was false. Intervention choice was influenced by availability of the operating room or ENDO suite, personal schedule, and personal skill set in 30.1%, 18.0%, and 45.9% of respondents, respectively. Most respondents reported routinely using paclitaxel-coated balloons (88.1%) and stents (67.5%); however, 73.3% altered practice when safety concerns were raised. Among surgeons, 17.8%, 2.9%, and 10.3% reported performing >10 annual alternative autogenous vein bypasses, composite vein composite vein bypasses, and bypasses to pedal targets, respectively. Among all interventionalists, 8%, 24%, and 8% reported performing >10 annual radial access procedures, pedal or tibial access procedures, and pedal loop revascularizations. The majority (89.1%) of respondents felt that CLTI teams improved care; however, only 23.2% had a defined team. The effectiveness of the teamwork at institutions was characterized as highly effective in 42.5%. When comparing responses by VSs to the 2010 survey, there were no changes in preferred treatment based on Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classification or conduit preference. In 2022, OPEN surgery was preferred more for a popliteal occlusion. For clinical scenarios, there were no differences except a decreased proportion of respondents who felt there was equipoise for major tissue loss for major tissue loss (43.8% vs 31.2%) and increased ENDO choice for minor tissue loss (17.6% vs 30.8%) (P < .05). CONCLUSIONS: There is a wide range of practice patterns among vascular specialists treating CLTI. The majority of investigators in BEST-CLI had experience in both advanced OPEN and ENDO techniques and represent a real-world sample of technical expertise. Over the course of the decade of the BEST-CLI trial, there was overall similar equipoise among VSs. CI - Copyright (c) 2024. Published by Elsevier Inc. FAU - Farber, Alik AU - Farber A AD - Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA. Electronic address: alik.farber@bmc.org. FAU - Siracuse, Jeffrey J AU - Siracuse JJ AD - Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA. FAU - Giles, Kristina AU - Giles K AD - Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME. FAU - Jones, Douglas W AU - Jones DW AD - Division of Vascular Surgery, UMass Memorial Health, Worcester, MA. FAU - Laskowski, Igor A AU - Laskowski IA AD - Division of Vascular and Endovascular Surgery, Westchester Medical Center, Valhalla, NY; Department of Surgery, Section of Vascular Surgery, New York Medical College, Valhalla, NY. FAU - Powell, Richard J AU - Powell RJ AD - Dartmouth Hitchcock Medical Center, Heart and Vascular Center, Geisel School of Medicine at Dartmouth, Lebanon, NH. FAU - Rosenfield, Kenneth AU - Rosenfield K AD - Section of Vascular Medicine and Intervention Massachusetts General Hospital, Harvard Medical School, Boston, MA. FAU - Strong, Michael B AU - Strong MB AD - Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. FAU - White, Christopher J AU - White CJ AD - Department of Cardiovascular Diseases, The Ochsner Clinical School, University of Queensland, Queensland, Australia. FAU - Doros, Gheorghe AU - Doros G AD - School of Public Health, Boston University, Boston, MA. FAU - Menard, Matthew T AU - Menard MT AD - Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. LA - eng PT - Journal Article DEP - 20231205 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 SB - IM MH - Humans MH - Prospective Studies MH - Treatment Outcome MH - *Endovascular Procedures/methods MH - *Peripheral Arterial Disease/diagnostic imaging/surgery MH - Veins/surgery MH - Ischemia MH - Chronic Limb-Threatening Ischemia MH - Limb Salvage/methods MH - Risk Factors MH - Retrospective Studies OTO - NOTNLM OT - Bypass OT - Chronic limb ischemia OT - Endovascular COIS- Disclosures A.F. has received a grant from the Novo Nordisk Foundation; is a consultant for Sanifit, LeMaitre, and BioGenCell; and is on the advisory board of Dialysis-X and iThera Medical. M.M. is an advisor for Janssen. K.G. is an advisory board member for Boston Scientific. K.R. receives income as a consultant or member of a scientific advisory board for the following entities: Abbott Vascular; Althea Medical; Angiodynamics; Auxetics; Becton-Dickinson; Boston Scientific; Contego; Crossliner; Innova Vascular; Inspire MD; Janssen/Johnson and Johnson; Magneto; Mayo Clinic; MedAlliance; Medtronic; Neptune Medical; Penumbra; Philips; Surmodics; Terumo; Thrombolex; Truvic; Vasorum; Vumedi. KR owns equity or stock options in the following entities: Access Vascular; Aerami; Althea Medical; Auxetics; Contego; Crossliner; Cruzar Systems; Endospan; Imperative Care/Truvic; Innova Vascular; InspireMD; JanaCare; Magneto; MedAlliance; Neptune Medical; Orchestra; Prosomnus; Shockwave; Skydance; Summa Therapeutics; Thrombolex; Vasorum; Vumedi. K.R. or his institution (on my behalf) receive research grants from the following entities: NIH; Abiomed; Boston Scientific; Novo Nordisk Foundation; Penumbra; Gettinge-Atrium. K.R. serves as a member of the Board of Directors of the following organization: The National PERT ConsortiumTM. EDAT- 2023/12/07 00:42 MHDA- 2024/03/25 06:43 CRDT- 2023/12/06 19:26 PHST- 2023/10/31 00:00 [received] PHST- 2023/11/22 00:00 [revised] PHST- 2023/11/28 00:00 [accepted] PHST- 2024/03/25 06:43 [medline] PHST- 2023/12/07 00:42 [pubmed] PHST- 2023/12/06 19:26 [entrez] AID - S0741-5214(23)02304-2 [pii] AID - 10.1016/j.jvs.2023.11.045 [doi] PST - ppublish SO - J Vasc Surg. 2024 Apr;79(4):865-874. doi: 10.1016/j.jvs.2023.11.045. Epub 2023 Dec 5.