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A Phase 1 Study Of A Novel Bidirectional Femoral Arterial Cannula For The Prevention Of Leg Ischaemia During Cardiac Surgery
Silvana F. Marasco1, Elli Tutungi2, Vincent A. Pellegrino1, Shirley A. Vallance1, Randall A. Moshinsky3.
1Alfred Hospital, Melbourne, Australia, 2Cabrini Hospital, Melbourne, Australia, 3Monash Medical Centre, Melbourne, Australia.
Background:
Leg ischaemia is a serious complication of femoral artery cannulation. A novel bi-directional femoral arterial cannula (Sorin Group USA, a wholly-owned subsidiary of LivaNova PLC, Arvada, Colorado, USA) that provides both antegrade and retrograde flow was evaluated in this study. The safety and efficacy of this device was evaluated in patients undergoing cardiac surgery requiring peripheral cannulation for cardiopulmonary bypass (CPB).
Methods:
Written informed consent was obtained in the ambulatory setting. Post induction of anaesthesia, all cannulae were inserted directly into the femoral artery via a surgical cut-down and wire-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 reflectance near-infrared spectroscopy (NIRS) as a measure of regional oxygen saturation (rSO2). A baseline measure was obtained prior to cannulation, at the commencement of CPB, and then 15-minutely.
Results:
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 to December 2016. Indications included minimally invasive mitral and aortic valve surgery, thoracic aortic aneurysm repair, and redo cardiac surgery. The median duration of CPB was 160 minutes (range 86-288). The cannula was inserted and positioned without difficulty in all patients. Antegrade flow in the SFA was observed on Doppler ultrasound in 5 out of 6 patients. Technical difficulties with probe placement prevented imaging of the SFA in one patient. Continuous stable distal perfusion was demonstrated in the cannulated limb in all patients during CPB. The cannula was removed without difficulty in all cases, and there were no reported procedural complications.
Conclusions:
The use of a novel bi-directional femoral arterial cannula in patients requiring peripheral cannulation for CPB was associated with stable distal perfusion of the cannulated limb, obviating the need to insert a separate downstream perfusion cannula or use other techniques to protect against lower limb ischaemia. No procedural complications were noted. Recruitment is ongoing, in addition to a parallel study evaluating the novel bidirectional cannula in patients receiving veno-arterial extracorporeal membrane oxygenation.
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