Distal Puncture-Assisted Bidirectional Endovascular Therapy for Femoropopliteal Chronic Total Occlusion: Efficacy and CIRSE-Graded Complications (DIPLOMA Study)
Yuichiro Hosoi, Yuki Katagiri, Shuko Iwata, Riho Suzuki, Yuki Tanaka, Yutaro Kasai, Michinao Tan, Seiji YamazakiPurpose:
To evaluate the efficacy and periprocedural safety of distal puncture-assisted bidirectional endovascular therapy (EVT) for de novo femoropopliteal chronic total occlusion (FP-CTO).
Methods:
This multicenter retrospective study included 5 institutions and was conducted between 2019 and 2022. Outcomes and complications were analyzed per procedure (94 procedures); major amputation and mortality were assessed per patient based on the index procedure (87 patients). Major complications were defined as the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification grade ≥3.
Results:
Wire-crossing success was 98.9%, and technical success was 84.0%. Complications occurred in 23.4% of procedures, including major complications in 8.5% and distal access-site complications in 10.6%, with no major distal access-site complications observed. Distal embolization occurred in 6.4% of procedures and was uniformly graded as CIRSE grade 1. At 1 year, freedom from target lesion revascularization was 82.0%, whereas limb salvage and overall survival were 97.0% and 85.6%, respectively.
Conclusion:
In this selected multicenter cohort, distal puncture-assisted bidirectional EVT achieved a high wire-crossing success rate, with no adjudicated major distal access-site complication identified using the CIRSE classification. However, these safety findings should be interpreted with caution, as failed distal puncture attempts were not captured and the temporal attribution of distal embolization could not be fully established.
Clinical Impact
Distal puncture-assisted bidirectional endovascular therapy may be a useful bailout or planned strategy for complex femoropopliteal chronic total occlusions when conventional antegrade crossing is difficult. This multicenter study provides contemporary procedural outcomes and Cardiovascular and Interventional Radiological Society of Europe-graded complication profiles, allowing clinicians to interpret not only technical success but also the severity and clinical relevance of complications. The findings may help operators discuss procedural risk, select appropriate access strategies, and standardize complication reporting in femoropopliteal CTO interventions. Further studies including attempted but unsuccessful distal puncture cases are needed to define the overall risk-benefit profile of this approach.