New-generation single-layer PTFE-covered coronary stent for endovascular repair of iatrogenic arterial side-branch injury in non-coronary lesions for the RECOVER (REsults after percutaneous interventions with COVERed stents) Investigators.

Abstract

Background: The incidence of iatrogenic injuries in peripheral arteries is increasing due to the expanding opportunities of managing various cardiovascular diseases by means of percutaneous intervention. Thus, endovascular repair with implantation of covered stent (CS) after vascular injury is gaining importance as an alternative to open surgery. In cases of smaller side-branch injuries, stenting of the main vessel with subsequent exclusion and sealing of the side-branch is associated with unfavourable revascularization rates and unpredictable ischemic complications in the corresponding supply area.

Objective: This study reports the procedural and clinical outcomes of patients with iatrogenic vascular side-branch injuries treated with coronary-CS directly at the site of injury.

Methods: This is a retrospective, multicentre registry study, including 40 patients with acute iatrogenic injuries of arterial side-branches undergoing implantation of single-layer polytetrafluorethylene (PTFE)-CS at 3 different centres in Europe between June 2014 and June 2023. Endpoints were procedural success, death, target vessel reintervention (TVR), bleeding and the need for surgical conversion.

Results: A total of 40 patients underwent implantation of single-layer PTFE-CS in the lower (97.5 %) and the upper limbs (2.5 %). The most common mechanisms were injuries after punctures, caused by needle and/or sheath (80 %), balloon-dilations (7.5 %) and during/after non-cardiac surgery (7.5 %). Procedural success was achieved in all cases (100 %). The rate of in-hospital mortality was 7.5 %. The median duration of hospitalization after the CS procedure was 4 days [2; 5.3]. At a median follow-up of 202.5 days [97.3-711.8], 36 patients (90 %) were alive and main vessel patency was 100 %. There were no cases of TVRs, bleedings or surgical conversions. Access-site related complications occurred in 5 % of all cases.

Conclusions: In this study, the use of new-generation single-layer PTFE-covered coronary stents in non-coronary side-branch lesions after iatrogenic arterial injury shows a high technical success rate and favourable clinical efficacy and safety.