Progression of tricuspid regurgitation was substantially lower in patients who received mitral-valve surgery with concomitant tricuspid repair compared with patients who had mitral-valve surgery alone, according to clinical trial results published in the New England Journal of Medicine.

For the multicenter, randomized trial (ClinicalTrials.gov Identifier: NCT02675244), researchers sought to evaluate the impact of concomitant tricuspid-valve repair in patients with mild to moderate tricuspid regurgitation receiving mitral-valve surgery. A total of 401 patients with degenerative mitral regurgitation were randomly assigned to receive mitral-valve surgery with tricuspid annuloplasty or mitral-valve surgery alone. Randomization was stratified according to baseline severity of tricuspid regurgitation.

Patients were followed for 2 years, and the primary endpoint was the composite events of reoperation for tricuspid regurgitation, progression from baseline of tricuspid regurgitation by 2 grades or evidence of severe tricuspid regurgitation, or death.


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Primary endpoint events were reported in 3.9% of the mitral-valve surgery plus tricuspid annuloplasty group and in 10.2% of the mitral-valve surgery-alone group (relative risk [RR], 0.37; 95% CI, 0.16-0.86; P =.02). The 2-year mortality rate for mitral-valve surgery plus tricuspid annuloplasty vs  mitral-valve surgery alone was 3.2% and 4.5%, respectively ([RR], 0.69; 95% CI, 0.25-1.88).

At 2 years, progression of tricuspid regurgitation in surgery plus tricuspid annuloplasty vs mitral-valve surgery alone was lower (0.6% vs 6.1%; RR, 0.09; 95% CI, 0.01-0.69). The occurrence of other major adverse cardiac and cerebrovascular events (MACCE), functionality, and quality of life (QOL) postsurgery were similar in both groups. However, the surgery-plus group was more likely to require permanent pacemaker implantation than the mitral-valve surgery-alone group (14.1% vs 2.5%; rate ratio, 5.75; 95% CI, 2.27-14.60).

Limitations to the study included a cohort that lacked diversity and was, therefore, not representative of the broader patient population, as well as a relatively short follow-up period that may not have fully captured the long-term clinical effect of progression of tricuspid regurgitation or permanent pacemaker implantation.

“The inclusion of [tricuspid annuloplasty] at the time of mitral-valve surgery resulted in a lower risk of a primary endpoint event at 2 years than surgery alone, a reduction that was driven by less frequent progression to severe tricuspid regurgitation,” the study authors said. “This reduction in disease progression came at the cost of a higher risk of permanent pacemaker implantation. Otherwise, patients in the [2] treatment groups had similar outcomes with respect to MACCE, [QOL], functional status, hospital readmission, and death.”

Reference

Gammie JS, Chu MWA, Falk V, et al. Concomitant tricuspid repair in patients with degenerative mitral regurgitation. N Engl J Med. Published online November 13, 2021. doi:10.1056/NEJMoa2115961