A phase 1 study of a novel bidirectional femoral arterial cannula for the prevention of leg ischemia during cardiac surgical procedures.

Abstract

Objective: Leg ischemia is a serious complication of femoral artery cannulation. A novel bidirectional femoral arterial cannula (Sorin Group USA, a wholly owned subsidiary of LivaNova PLC, Arvada, CO USA) that provides both antegrade and retrograde flow was evaluated in this study. The safety and efficacy of this device were evaluated in patients undergoing cardiac surgical procedures requiring peripheral cannulation for cardiopulmonary bypass (CPB). Method(s): Written informed consent was obtained in the ambulatory setting. After induction of anesthesia, all cannulas were inserted directly into the femoral artery via a surgical cutdown and awire-through-needle technique. Flow in the superficial femoral artery (SFA) was assessed using Doppler ultrasound after commencement of CPB. Lower limb perfusion was assessed using near-infrared reflectance spectroscopy as a measure of regional oxygen saturation. A baseline measure was obtained prior to cannulation, at the commencement of CPB, and then every 15 minutes. Result(s): Six patients (median age 63.5 years, range 35-77) underwent femoral arterial cannulation using the novel bidirectional femoral arterial cannula at the Alfred Hospital, Melbourne, Australia, between August and December 2016. Indications included minimally invasive thoracotomy because of coagulopathy and poor pulmonary complianceThis patient and the smallest patient (surgical weight, 420 g) (3.2%) died of bronchial bleeding. There was 1 hospital death of renal failure. Sixty patients (95.2%) were discharged home without any complications. The mean follow-up period was 70 months. Follow-up examinations have demonstrated no residual shunts and no late deaths. The multiple regression analyses (Cox regression hazard model) indicated that the body weight at surgery is the only potential risk factor for death (hazard ratio, 0.976, 95% CI, 0.956-0.997, P = 0.025). Conclusion(s): The VATS technique is safe and less invasive and provides excellent surgical results for PDA interruption in extremely low birth weight neonates less than 1 kg.