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Randomised trial of mitral valve repair with leaflet resection versus leaflet preservation on functional mitral stenosis (The CAMRA CardioLink-2 Trial).

ABSTRACT: BACKGROUND:The gold-standard treatment of severe mitral regurgitation (MR) due to degenerative disease is valve repair, which is surgically performed with either a leaflet resection or leaflet preservation approach. Recent data suggest that functional mitral stenosis (MS) may occur following valve repair using a leaflet resection strategy, which adversely affects patient prognosis. A randomised comparison of these two approaches to mitral repair on functional MS has not been conducted. METHODS AND ANALYSIS:This is a prospective, multicentre randomised controlled trial designed to test the hypothesis that leaflet preservation leads to better preservation of mitral valve geometry, and therefore, will be superior to leaflet resection for the primary outcome of functional MS as assessed by 12-month mean mitral valve gradient at peak exercise. Eighty-eight patients with posterior leaflet prolapse will be randomised intraoperatively once deemed by the operating surgeon to feasibly undergo mitral repair using either a leaflet resection or leaflet preservation approach. Secondary end points include comparison of repair strategies with regard to mitral valve orifice area, leaflet coaptation height, 6?min walk test and a composite major adverse event end point consisting of recurrent MR ?2+, death or hospital readmission for congestive heart failure within 12?months of surgery. ETHICS AND DISSEMINATION:Institutional ethics approval has been obtained from all enrolling sites. Overall, there remains clinical equipoise regarding the mitral valve repair strategy that is associated with the least likelihood of functional MS. This trial hopes to introduce high-quality evidence to help surgical decision making in this context. TRIAL REGISTRATION NUMBER:NCT02552771.

SUBMITTER: Chan V

PROVIDER: S-EPMC5729977 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Randomised trial of mitral valve repair with leaflet resection versus leaflet preservation on functional mitral stenosis (The CAMRA CardioLink-2 Trial).

Chan Vincent V Chu Michael W A MWA Leong-Poi Howard H Latter David A DA Hall Judith J Thorpe Kevin E KE de Varennes Benoit E BE Quan Adrian A Tsang Wendy W Dhingra Natasha N Yared Kibar K Teoh Hwee H Chu F Victor FV Chan Kwan-Leung KL Mesana Thierry G TG Connelly Kim A KA Ruel Marc M Jüni Peter P Mazer C David CD Verma Subodh S

BMJ open 20170530 5

<h4>Background</h4>The gold-standard treatment of severe mitral regurgitation (MR) due to degenerative disease is valve repair, which is surgically performed with either a leaflet resection or leaflet preservation approach. Recent data suggest that functional mitral stenosis (MS) may occur following valve repair using a leaflet resection strategy, which adversely affects patient prognosis. A randomised comparison of these two approaches to mitral repair on functional MS has not been conducted.<h ...[more]

PMID: 28566364

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Project description:ObjectiveMitral valve repair is superior to replacement for degenerative disease, but long-term outcomes of anterior versus posterior leaflet repair remain poorly defined. We propensity matched anterior and posterior repairs to compare long-term outcomes.MethodsPatients undergoing first-time degenerative mitral repair between 1992 and 2018 were identified. Primary outcome was overall survival. Secondary outcomes were postprocedural residual mitral regurgitation and reoperation. From 1025 patients, 1:1 propensity score matching was performed, yielding 309 anterior (isolated anterior = 85, bileaflet = 224) and 309 isolated posterior repairs.ResultsAge was 58 ± 15 years, ejection fraction was 57% ± 10%, and matched groups were well balanced. Anterior repairs had longer bypass (122 ± 53 vs 109 ± 43 minutes, P = .001) and crossclamp (94 ± 44 vs 85 ± 62 minutes, P = .033) times. Mean residual mitral regurgitation grade was 0.44 (95% confidence interval, 0.24-0.65) for anterior repair and 0.30 (95% confidence interval, 0.13-0.47) for posterior repair (P = .31). Overall, 92% (569/618) of matched patients had no residual mitral regurgitation, with no differences in mitral regurgitation grade between groups (P = .77). Survival did not differ between anterior (10 years: 72% ± 7%; 15 years: 63% ± 7%) and posterior (10 years: 74% ± 7%; 15 years: 60% ± 8%) groups (log-rank P = .93). Linearized incidence of reoperation was 0.62% per patient-year, including 0.74% for anterior and 0.48% for posterior repairs. Cumulative incidence of reoperation at 15 years was 7.5% after anterior repair and 4.9% after posterior repair (Gray's test P = .26).ConclusionsNo long-term survival or reoperation difference was found between posterior and anterior repair. On the basis of these findings, surgeons at centers of excellence should aim for repair of both anterior and posterior leaflet pathology with the same decision-making threshold over valve replacement for degenerative mitral disease.

Project description:IntroductionNumbers of patients undergoing mitral valve repair (MVr) surgery for severe mitral regurgitation have grown and will continue to rise. MVr is routinely performed via median sternotomy; however, there is a move towards less invasive surgical approaches.There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.The UK Mini Mitral trial will provide definitive evidence comparing patient, NHS and clinical outcomes in adult patients undergoing MVr surgery. It will establish the best surgical approach for MVr, setting a standard against which emerging percutaneous techniques can be measured. Findings will inform optimisation of cost-effective practice.Methods and analysisUK Mini Mitral is a multicentre, expertise based randomised controlled trial of minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr. The trial is taking place in NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes. In each centre, consenting and eligible patients are randomised to receive surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria. Patients are followed for 1 year, and consent to longer term follow-up.Primary outcome is physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale. Early and 1 year echo data will be reported by a core laboratory. Estimates of key clinical and health economic outcomes will be reported up to 5 years.The primary economic outcome is cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery.Ethics and disseminationA favourable opinion was given by Wales REC 6 (16/WA/0156). Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer reviewed publication.Trial registration numberISRCTN13930454.

Project description:BackgroundIschemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited.MethodsWe randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank.ResultsAt 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, -6.6 and -6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement group (hazard ratio with repair, 0.79; 95% confidence interval, 0.42 to 1.47; P=0.45 by the log-rank test). There was no significant between-group difference in LVESVI after adjustment for death (z score, 1.33; P=0.18). The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group (32.6% vs. 2.3%, P<0.001). There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events, in functional status, or in quality of life at 12 months.ConclusionsWe observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement. Replacement provided a more durable correction of mitral regurgitation, but there was no significant between-group difference in clinical outcomes. (Funded by the National Institutes of Health and the Canadian Institutes of Health; ClinicalTrials.gov number, NCT00807040.).

Dataset Information

Randomised trial of mitral valve repair with leaflet resection versus leaflet preservation on functional mitral stenosis (The CAMRA CardioLink-2 Trial).

Publications

Randomised trial of mitral valve repair with leaflet resection versus leaflet preservation on functional mitral stenosis (The CAMRA CardioLink-2 Trial).

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