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

ABSTRACT: 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.

SUBMITTER: Krag AE

PROVIDER: S-EPMC7015612 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Krag Andreas E AE Hvas Anne-Mette AM Hvas Christine L CL Kiil Birgitte J BJ

Plastic and reconstructive surgery. Global open 20200121 1

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.<h4>Methods</h4>Head and neck cancer patients undergoing tumor resection and microsurgical reconstruction were include ...[more]

PMID: 32095401

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Project description:BACKGROUND:Cancer patients who undergo tumor removal, and reconstructive surgery by transfer of a free tissue flap, are at high risk of surgical site infection and ischemia-reperfusion injury. Complement activation through the lectin pathway (LP) may contribute to ischemia-reperfusion injury. Remote ischemic preconditioning (RIPC) is a recent experimental treatment targeting ischemia-reperfusion injury. The study aims were to investigate LP protein plasma levels in head and neck cancer patients compared with healthy individuals, to explore whether RIPC affects LP protein levels in head and neck cancer surgery, and finally to examine the association between postoperative LP protein levels and the risk of surgical site infection. METHODS:Head and neck cancer patients (n = 60) undergoing tumor resection and reconstructive surgery were randomized 1:1 to RIPC or sham intervention administered intraoperatively. Blood samples were obtained preoperatively, 6 hours after RIPC/sham, and on the first postoperative day. LP protein plasma levels were measured utilizing time-resolved immunofluorometric assays. RESULTS:H-ficolin and M-ficolin levels were significantly increased in cancer patients compared with healthy individuals (both P ≤ 0.02). Conversely, mannan-binding lectin (MBL)-associated serine protease (MASP)-1, MASP-3, collectin liver-1 (CL-L1), and MBL-associated protein of 44 kilodalton (MAp44) levels were decreased in cancer patients compared with healthy individuals (all P ≤ 0.04). A significant reduction in all LP protein levels was observed after surgery (all P < 0.001); however, RIPC did not affect LP protein levels. No difference was demonstrated in postoperative LP protein levels between patients who developed surgical site infection and patients who did not (all P > 0.13). CONCLUSIONS:The LP was altered in head and neck cancer patients. LP protein levels were reduced after surgery, but intraoperative RIPC did not influence the LP. Postoperative LP protein levels were not associated with surgical site infection.

Project description:Multiple randomized controlled trials of remote ischemic preconditioning (RIPC) prior to cardiac surgery have failed to demonstrate clinical benefit. The aim of this updated meta-analysis was to evaluate the effect of RIPC on outcomes following cardiac surgery.Searches of PubMed, Cochrane, EMBASE, and Web of Science databases were performed for 1970 to December 13, 2015. Randomized controlled trials comparing RIPC with a sham procedure prior to cardiac surgery performed with cardiopulmonary bypass were assessed. All-cause mortality, acute kidney injury (AKI), and myocardial infarction were the primary outcomes of interest. We identified 21 trials that randomized 5262 patients to RIPC or a sham procedure prior to undergoing cardiac surgery. The majority of patients were men (72.6%) and the mean or median age ranged from 42.3 to 76.3 years. Of the 9 trials that evaluated mortality, 188 deaths occurred out of a total of 4210 randomized patients, with 96 deaths occurring in 2098 patients (4.6%) randomized to RIPC and 92 deaths occurring in 2112 patients (4.4%) randomized to a sham control procedure, demonstrating no significant reduction in all-cause mortality (risk ratio [RR], 0.987; 95% CI, 0.653-1.492, P=0.95). Twelve studies evaluated AKI in 4209 randomized patients. In these studies, AKI was observed in 516 of 2091 patients (24.7%) undergoing RIPC and in 577 of 2118 patients (27.2%) randomized to a sham procedure. RIPC did not result in a significant reduction in AKI (RR, 0.839; 95% CI, 0.703-1.001 [P=0.052]). In 6 studies consisting of 3799 randomized participants, myocardial infarction occurred in 237 of 1891 patients (12.5%) randomized to RIPC and in 282 of 1908 patients (14.8%) randomized to a sham procedure, resulting in no significant reduction in postoperative myocardial infarction (RR, 0.809; 95% CI, 0.615-1.064 [P=0.13]). A subgroup analysis was performed a priori based on previous studies suggesting that propofol may mitigate the protective benefits of RIPC. Three studies randomized patients undergoing cardiac surgery to RIPC or sham procedure in the absence of propofol anesthesia. Most of these patients were men (60.3%) and the mean or median age ranged from 57.0 to 70.6 years. In this propofol-free subgroup of 434 randomized patients, 71 of 217 patients (32.7%) who underwent RIPC developed AKI compared with 103 of 217 patients (47.5%) treated with a sham procedure. In this cohort, RIPC resulted in a significant reduction in AKI (RR, 0.700; 95% CI, 0.527-0.930 [P=0.014]). In studies of patients who received propofol anesthesia, 445 of 1874 (23.7%) patients randomized to RIPC developed AKI compared with 474 of 1901 (24.9%) who underwent a sham procedure. The RR for AKI was 0.928 (95% CI, 0.781-1.102; P=0.39) for RIPC versus sham. There was no significant interaction between the two subgroups (P=0.098).RIPC does not reduce morbidity or mortality in patients undergoing cardiac surgery with cardiopulmonary bypass. In the subgroup of studies in which propofol was not used, a reduction in AKI was seen, suggesting that propofol may interact with the protective effects of RIPC. Future studies should evaluate RIPC in the absence of propofol anesthesia.

Dataset Information

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

Publications

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

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