Dataset Information

Remote ischaemic preconditioning in isolated aortic valve and coronary artery bypass surgery: a randomized trial†.

ABSTRACT:

Objectives

This trial was designed and patients were recruited at a time when the benefits of remote ischaemic preconditioning during open-heart surgery were still controversial. We focused on a homogeneous patient population undergoing either isolated aortic valve replacement or coronary artery bypass grafting (CABG) surgery by investigating cardiac injury, metabolic stress and inflammatory response.

Methods

A 2-centre randomized controlled trial recruited a total of 124 patients between February 2013 and April 2015. Of them, 64 patients underwent CABG and 60 patients underwent aortic valve replacement. Patients were randomized to either sham or preconditioning. Remote ischaemic preconditioning was applied following anaesthesia and before sternotomy. Myocardial injury and inflammatory response were assessed by serially measuring cardiac troponin I, and interleukin-6, 8, 10 and the tumour necrosis factor (TNF-?). Biopsies from the left and the right ventricles were harvested after ischaemic reperfusion injury for nucleotides analysis.

Results

Application of remote ischaemic preconditioning did not alter the degree of troponin I release, levels of inflammatory markers and cardiac energetics in both the CABG and the aortic valve replacement groups.

Conclusions

Preconditioning did not confer any additional cardioprotection in terms of reducing the levels of troponin I and inflammatory markers and preserving left and right ventricle energy metabolites in patients undergoing isolated CABG or aortic valve surgery.

Clinical trial registration number

International Standard Randomized Controlled Trial Number (ISRCTN) registry ID 33084113 (doi: 10.1186/ISRCTN33084113) and UK controlled randomized trial number (UKCRN) registry ID 13672.

SUBMITTER: Moscarelli M

PROVIDER: S-EPMC6477640 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

Remote ischaemic preconditioning in isolated aortic valve and coronary artery bypass surgery: a randomized trial†.

Moscarelli Marco M Fiorentino Francesca F Suleiman M-Saadeh MS Emanueli Costanza C Reeves Barnaby C BC Punjabi Prakash P PP Angelini Gianni D GD

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 20190501 5

<h4>Objectives</h4>This trial was designed and patients were recruited at a time when the benefits of remote ischaemic preconditioning during open-heart surgery were still controversial. We focused on a homogeneous patient population undergoing either isolated aortic valve replacement or coronary artery bypass grafting (CABG) surgery by investigating cardiac injury, metabolic stress and inflammatory response.<h4>Methods</h4>A 2-centre randomized controlled trial recruited a total of 124 patients ...[more]

PMID: 30544237

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Project description:BackgroundRemote ischaemic preconditioning (RIPC) is a cardioprotective intervention invoking intermittent periods of ischaemia in a tissue or organ remote from the heart. The mechanisms of this effect are incompletely understood. We hypothesised that RIPC might enhance coronary vasodilatation by an endothelium-dependent mechanism.MethodsWe performed a prospective, randomised, sham-controlled, blinded clinical trial. Patients with stable coronary artery disease (CAD) undergoing elective invasive management were prospectively enrolled, and randomised to RIPC or sham (1:1) prior to angiography. Endothelial-dependent vasodilator function was assessed in a non-target coronary artery with intracoronary infusion of incremental acetylcholine doses (10-6, 10-5, 10-4mol/l). Venous blood was sampled pre- and post-RIPC or sham, and analysed for circulating markers of endothelial function. Coronary luminal diameter was assessed by quantitative coronary angiography. The primary outcome was the between-group difference in the mean percentage change in coronary luminal diameter following the maximal acetylcholine dose (Clinicaltrials.gov identifier: NCT02666235).Results75 patients were enrolled. Following angiography, 60 patients (mean±SD age 57.5±8.5years; 80% male) were eligible and completed the protocol (n=30 RIPC, n=30 sham). The mean percentage change in coronary luminal diameter was -13.3±22.3% and -2.0±17.2% in the sham and RIPC groups respectively (difference 11.32%, 95%CI: 1.2- 21.4, p=0.032). This remained significant when age and sex were included as covariates (difference 11.01%, 95%CI: 1.01- 21.0, p=0.035). There were no between-group differences in endothelial-independent vasodilation, ECG parameters or circulating markers of endothelial function.ConclusionsRIPC attenuates the extent of vasoconstriction induced by intracoronary acetylcholine infusion. This endothelium-dependent mechanism may contribute to the cardioprotective effects of RIPC.

Project description:BackgroundDespite advances in perioperative care, elective major vascular surgical procedures still carry a significant risk of morbidity and mortality. Remote ischaemic preconditioning (RIPC) is the temporary blocking of blood flow to vascular beds remote from those targeted by surgery. It has the potential to provide local tissue protection from further prolonged periods of ischaemia. However, the efficacy and safety of RIPC in people undergoing major vascular surgery remain unknown. This is an update of a review published in 2011. OBJECTIVES: To assess the benefits and harms of RIPC versus no RIPC in people undergoing elective major vascular and endovascular surgery.Search methodsThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to 1 April 2022.Selection criteriaWe included all randomised controlled trials that evaluated the role of RIPC in reducing perioperative mortality and morbidities in people undergoing elective major vascular or endovascular surgery.Data collection and analysisWe collected data on the characteristics of the trial, methodological quality, and the remote ischaemic preconditioning stimulus used. Our primary outcome was perioperative mortality, and secondary outcomes included myocardial infarction, renal impairment, stroke, hospital stay, limb loss, and operating time or total anaesthetic time. We analysed the data using random-effects models. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) based on an intention-to-treat analysis. In addition, we used GRADE to assess the certainty of the evidence for each outcome.Main resultsWe included 14 trials which randomised a total of 1295 participants (age range: 64.5 to 76 years; 84% male; study periods ranged from 2003 to 2019). In general, the included studies were at low to unclear risk of bias for most risk of bias domains. The certainty of evidence of main outcomes was moderate due to imprecision of results, moderate heterogeneity, or possible publication bias. We found that RIPC made no clear difference in perioperative mortality compared with no RIPC (RR 1.41, 95% CI 0.59 to 3.40; I2 = 0%; 10 studies, 965 participants; moderate-certainty evidence). Similarly, we found no clear difference between the two groups for myocardial infarction (RR 0.82, 95% CI 0.49 to 1.40; I2 = 7%; 11 studies, 1001 participants; moderate-certainty evidence), renal impairment (RR 1.07, 95% CI 0.62 to 1.86; I2 = 40%; 12 studies, 1054 participants; moderate-certainty evidence), stroke (RR 0.33, 95% CI 0.04 to 3.15; I2 = 0%; 4 studies, 392 participants; moderate-certainty evidence), limb loss (RR 0.74, 95% CI 0.05 to 10.61; I2 = 32%; 3 studies, 322 participants; low-certainty evidence), hospital stay (MD -0.94 day, 95% CI -1.95 to 0.07; I2 = 17%; 7 studies, 569 participants; moderate-certainty evidence), and operating time or total anaesthetic time (MD 5.76 minutes, 95% CI -3.25 to 14.76; I2 = 44%; 10 studies, 803 participants; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Overall, compared with no RIPC, RIPC probably leads to little or no difference in perioperative mortality, myocardial infarction, renal impairment, stroke, hospital stay, and operating time, and may lead to little or no difference in limb loss in people undergoing elective major vascular and endovascular surgery. Adequately powered and designed randomised studies are needed, focusing in particular on the clinical endpoints and patient-centred outcomes.

Dataset Information

Remote ischaemic preconditioning in isolated aortic valve and coronary artery bypass surgery: a randomized trial†.

Objectives

Methods

Results

Conclusions

Clinical trial registration number

Publications

Remote ischaemic preconditioning in isolated aortic valve and coronary artery bypass surgery: a randomized trial†.

Similar Datasets

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