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Randomized Controlled Trial

Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation

James S Gammie et al. N Engl J Med. .

Abstract

Background: Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.

Methods: We randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.

Results: Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).

Conclusions: Among patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).

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Figures

Figure 1.
Figure 1.
Event-free Survival Curves for Mortality and MACCE. Panel A depicts time to all cause death. Panel B depicts time to first major cerebrovascular or cardiac event (MACCE) defined as the composite event of death, stroke, and serious heart failure events
Figure 2.
Figure 2.
Echocardiographic and Functional Status Overtime. Panel A depicts degree of TR, panel B depicts degree of MR, and panel C gives NYHA over two year post-randomization.
Figure 2.
Figure 2.
Echocardiographic and Functional Status Overtime. Panel A depicts degree of TR, panel B depicts degree of MR, and panel C gives NYHA over two year post-randomization.
Figure 2.
Figure 2.
Echocardiographic and Functional Status Overtime. Panel A depicts degree of TR, panel B depicts degree of MR, and panel C gives NYHA over two year post-randomization.

Comment in

References

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