A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery

OBJECTIVE: Leg ischemia is a serious complication of femoral artery cannulation. The primary aim of this study was to assess the safety and efficacy of 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, in patients undergoing peripheral cannulation for cardiopulmonary bypass during cardiac surgery. METHODS: Patients undergoing routine cardiac surgery requiring femoral artery cannulation for cardiopulmonary bypass were identified preoperatively. Informed written consent was obtained in all cases. Bidirectional cannula insertion used either a surgical cut-down and wire through needle approach or a percutaneous technique. Flow in the superficial femoral artery was assessed using Doppler ultrasound after commencement of cardiopulmonary bypass. Lower limb perfusion was assessed using reflectance near-infrared spectroscopy to measure regional oxygen saturations in the cannulated limb during cardiopulmonary bypass. RESULTS: Fifteen patients (median age = 61.3 years, range = 26–79 years, 10 males, 5 females) underwent femoral arterial cannulation using the novel bidirectional femoral cannula between August 2016 and May 2017. Fourteen cannulae were inserted directly into the femoral artery via a surgical cut-down and wire through needle technique. One bidirectional cannula was inserted using a percutaneous insertion technique. Indications included minimally invasive mitral and aortic valve surgery, thoracic aortic aneurysm repair, and redo cardiac surgery. The median duration of cardiopulmonary bypass was 129 minutes (range = 53–228 minutes). The cannula was inserted and positioned without difficulty in 14 of 15 patients. Incorrect sizing and arterial spasm prevented correct cannula positioning in one patient. Antegrade flow in the superficial femoral artery was observed on Doppler ultrasound in 12 of 12 patients in which this was performed. Continuous stable distal perfusion was demonstrated in the cannulated limb in 14 of 15 patients. No procedural complications occurred in the immediate or convalescent postoperative period. CONCLUSIONS: This study demonstrates that in patients undergoing femoral arterial cannulation for cardiopulmonary bypass during cardiac surgery, the use of a novel bidirectional cannula is safe and easy to insert and provides stable distal perfusion of the cannulated limb. Use of the device should largely obviate the need to insert a separate downstream perfusion cannula or use other techniques to protect against lower limb ischemia. Further research on a larger scale and in different patient populations is now warranted.