A Trans-Atlantic, Expert-Based, Delphi Consensus Document on controversial issues in the management of patients with chronic limb-threatening ischemia

BACKGROUND: Two recent multicenter randomized controlled trials (RCTs) compared best endovascular treatment versus surgical revascularization for patients with chronic limb-threatening ischemia (CLTI) and reached opposite conclusions. The aim of this international, expert-based Delphi Consensus document was to address these conflicting results and to explore their interpretation and applicability in the real-world clinical practice. METHODS: A three-round Delphi Consensus document was completed by 51 European and 17 USA-based experts addressing five pre-specified CLTI clinical scenarios and two questions regarding the applicability of the two RCTs. All answers were provided anonymously. The response rate for each round was 100%. Consensus was reached when ≥70% of the participants agreed on a response showing preference for a specific approach. RESULTS: Most participants (43/68; 63.3%) preferred a venous bypass for a patient with segmental occlusions of the lower limb arteries and an available distal target vessel, although this did not reach consensus. In contrast, consensus was achieved (49/68; 72.2%) for a diabetic patient with occlusion of all three infrapopliteal vessels for whom most experts favored angioplasty of any possible tibial artery. In case of previous endovascular recanalization failure, options were divided between repeat angioplasty (27 of 68; 39.7%) and venous bypass (35 of 68; 51.5%). The majority of participants reported that their approach had not changed following publication of the two RCTs (50 of 68; 73.5%) and did not believe that the trials had changed significantly the management of patients with CLTI in their clinical practice (53 of 68; 77.9%). In a subgroup analysis comparing European vs. USA-based physicians, there were minor differences in specific topics. CONCLUSIONS: In the present Expert-based Consensus document, considerable heterogeneity was found between USA-based and European participants on several topics related to CLTI and consensus was not always achieved. Endovascular and open surgical techniques should be regarded as complementary strategies, rather than as competing alternatives. Treatment should be individualized based on individual patient anatomy, extent of ischemia, presence of tissue loss, foot infection and conduit availability.