Journal Article

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

Chu, Michael W A, Ruel, Marc, Jüni, Peter, Chan, Kwan-Leung, Tsang, Wendy, Connelly, Kim A, Mesana, Thierry G, Leong-Poi, Howard, Chan, Vincent, Hall, Judith, Yared, Kibar, Teoh, Hwee, Mazer, C David, Thorpe, Kevin E, de Varennes, Benoit E, Dhingra, Natasha, Chu, F Victor, Latter, David A, Quan, Adrian, Verma, Subodh

2017

Overview

BackgroundThe 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 analysisThis 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 disseminationInstitutional 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 numberNCT02552771.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Cardiac Surgical Procedures - adverse effects / Cardiac Surgical Procedures - methods / Cardiology / Cardiovascular disease / Catheters / Death / Echocardiography / Evidence-based medicine / Heart failure / Heart Failure - etiology / Hospitals / Humans / Laboratories / Mitral Valve Insufficiency - diagnostic imaging / Mitral Valve Insufficiency - surgery / Mitral valve prolapse / Mitral Valve Stenosis - etiology / Ostomy / Patient Readmission / Prospective Studies / Pulmonary arteries / Recurrence / Research Design / Surgeons / Surgery / Task forces / Thoracic surgery / Walk Test / Workloads