Remote Ischemic Preconditioning in Microsurgical Head and Neck Reconstruction: A Randomized Controlled Trial

Abstract

Background: The free flap failure rate is 5% in head and neck microsurgical reconstruction, and ischemia-reperfusion injury is an important mechanism behind this failure rate. Remote ischemic preconditioning (RIPC) is a recent intervention targeting ischemia-reperfusion injury. The aim of the present study was to investigate if RIPC improved clinical outcomes in microsurgical reconstruction. Methods: Head and neck cancer patients undergoing tumor resection and microsurgical reconstruction were included in a randomized controlled trial. Patients were randomized (1:1) to RIPC or sham intervention administered intraoperatively just before transfer of the free flap. RIPC was administered by four 5-minute periods of upper extremity occlusion and reperfusion. Clinical data were prospectively collected in the perioperative period and at follow-up on postoperative days 30 and 90. Intention-to-treat analysis was performed. Results: Sixty patients were randomized to RIPC (n = 30) or sham intervention (n = 30). All patients received allocated intervention. No patients were lost to follow up. At 30-day follow-up, flap failure occurred in 7% of RIPC patients (n = 2) and 3% of sham patients (n = 1) with the relative risk and 95% confidence interval 2.0 [0.2;20.9], P = 1.0. The rate of pedicle thrombosis was 10% (n = 3) in both groups with relative risk 1.0 [0.2;4.6], P = 1.0. The flap failure rate did not change at 90-day follow-up. Conclusions: RIPC is safe and feasible but does not affect clinical outcomes in head and neck cancer patients undergoing microsurgical reconstruction.