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

Abstract

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.

Systematic review and meta-analysis of chordal replacement versus leaflet resection for posterior mitral leaflet prolapse

“…The Canadian Mitral Research Alliance (CAMRA) Randomized Controlled Trial (ClinicalTrials.gov; NCT02552771), a prospective trial comparing the incidence of functional mitral stenosis with resection versus neo-chordal repair, is currently enrolling patients and will shed light on this important issue. 40 Another interesting finding from this study is the higher postprocedural LVEF in the neo-chord group, which reached statistical significance in the RCT but not in the 2 observational studies that reported this outcome. The rationale for chordal techniques involves ''respecting'' the normal valvular geometry, which is intimately tied to left ventricular function.…”

Commentary: Much ado about nothing: Resect or respect?

“…5 Randomized trials of neochords versus resection techniques show clinical equivalence. 6 I do not use neochords because they require judgment and a little "art" in surgery, but I admit that is my opinion. Sometimes when I do a reoperation for failed neochord repair, the valve looks like a Picasso portrait-not a good look for a mitral valve.…”

Commentary: Assessing recovery of ejection fraction after mitral repair: One year after operation, are we there yet?

“…These data are an update of the initial trial report. 2 Other studies have compared the resect versus respect repair techniques, but there has been only 1 other randomized trial. 3 In terms of new data comparing LV volumes after resect versus respect repairs, this is a negative study with no differences seen.…”