Predictors of Patency Following Infrainguinal Arterial Interventions Under Intravascular Ultrasound Guidance: Analysis from the iDissection Studies.

Abstract

Background: Intravascular Ultrasound (IVUS) has been shown in smaller studies to improve outcomes when used to guide infrainguinal peripheral arterial interventions. The iDissection series of studies were conducted to determine the presence of dissections with various prepping devices in femoropopliteal and infrapopliteal arteries. The impact of IVUS-directed treatment on the long-term outcomes in these patients remains unclear.

Methods: All patients were enrolled at a single center with the exception of the Auryon BTK study (at 4 US centers). Seven prospective iDissection studies had been previously conducted with IVUS and the data was core lab adjudicated. We retrospectively analyzed major adverse limb events, freedom from target lesion revascularization (freedom from TLR) and patency at 1 year in these patients using medical records. The study was approved by a central ethics committee. Proportional and Kaplan-Meier survival analysis were performed. Logistic regression analysis to determine independent predictors of patency was performed.

Results: A total of 102 patients (n=135 encounters) were included. The median age was 72 years. 49.0% were diabetics and 50.0% had chronic limb-threatening ischemia (CLTI). 69.6% of lesions are de novo, 32.6% chronic total occlusion, 60.7% with moderate or severe calcium, and 72.6% femoropopliteal. Stent use was 38.5% (of which 53.8% drug eluting and 73.1% primary stenting), and drug-coated balloons 55.6%. Vessel prepping included atherectomy (66.7%), angioplasty (14.8%) and Flex VP (18.5%). Proportional Freedom from TLR at 1 year was 89.4%, and patency 89.4%. There was one major amputation. Mortality was 7.8% (95% CI; 3.49, 14.87). Logistic regression analysis showed that post balloon stenosis (odds ratio (OR) 1.07, p=0.015), tobacco use (OR 0.20, p=-0.007), presence of CTO (OR 3.59, p=0.019), and male sex (OR 3.85, p=0.035) were predictors of patency loss.

Conclusion: Infrainguinal arteries treated with IVUS guidance appears to have good patency and freedom from TLR. The presence of adventitial dissections does not appear to be predictive of patency likely confounded with the high use of drug-coated balloons and drug-eluting stents.