Individual patient data meta-analysis of patients treated with a heparin-bonded Viabahn in the femoropopliteal artery for chronic limb-threatening ischemia

Catheter Cardiovasc Interv. 2022 Apr;99(5):1714-1722. doi: 10.1002/ccd.30152. Epub 2022 Mar 7.

Abstract

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.

Keywords: amputation; chronic limb-threatening ischemia; covered stent; critical limb ischemia; endoprosthesis; femoropopliteal; heparin-bonded Viabahn.

Publication types

  • Meta-Analysis

MeSH terms

  • Amputation, Surgical
  • Blood Vessel Prosthesis
  • Blood Vessel Prosthesis Implantation*
  • Chronic Limb-Threatening Ischemia
  • Femoral Artery
  • Heparin / adverse effects
  • Humans
  • Ischemia / diagnostic imaging
  • Ischemia / etiology
  • Ischemia / therapy
  • Limb Salvage
  • Peripheral Arterial Disease* / diagnostic imaging
  • Peripheral Arterial Disease* / therapy
  • Popliteal Artery
  • Prosthesis Design
  • Treatment Outcome
  • Vascular Patency

Substances

  • Heparin

Grants and funding