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Pacemaker implantation associated with tricuspid repair in the setting of mitral valve surgery: Insights from a Cardiothoracic Surgical Trials Network randomized trial

Read at the 102nd Annual Meeting of The American Association for Thoracic Surgery, Boston, Massachusetts, May 14-17, 2022.
https://doi.org/10.1016/j.jtcvs.2022.11.031Get rights and content

Abstract

Objectives

In a recent trial, tricuspid annuloplasty (TA) during mitral valve surgery (MVS) for degenerative mitral regurgitation and moderate or less tricuspid regurgitation (TR) reduced the composite rate of death, reoperation for TR, or TR progression at 2 years. However, this benefit was counterbalanced by an increase in implantation of permanent pacemakers (PPMs). In this study, we analyzed the timing, indications, and risk factors for these implantations.

Methods

We randomized 401 patients (MVS alone = 203; MVS + TA = 198). Potential risk factors for PPMs were assessed using multivariable time-to-event models with death and PPM implantation for heart failure indications as competing risks.

Results

A PPM was implanted in 36 patients (9.6; 95% CI, 6.8-13.0) within 2 years of randomization, with 30/187 (16.0%) in the MVS + TA and 6/188 (3.2%) in the MVS groups (rate ratio, 5.08; 95% CI, 2.16-11.94; P < .001). Most (29/36; 80.6%) implantations occurred within 30 days postoperatively. Independent risk factors for PPM implantation within 2 years were TA (hazard ratio [HR], 5.94; 95% CI, 2.27-15.53; P < .001), increasing age (5 years, HR, 1.23; 95% CI, 1.01-1.52; P = .04), and left ventricular ejection fraction (LVEF; HR, 0.96; 95% CI, 0.92-0.99; P = .02). In the subset of TA recipients (n = 197), age (5 years, HR, 1.05; 95% CI, 1.00-1.10; P = .04) and LVEF (HR, 0.95; 95% CI, 0.91-0.99; P = .01) were associated with PPM within 2 years.

Conclusions

Concomitant TA, age, and baseline LVEF were risk factors for PPM implantation in patients who underwent MVS for degenerative mitral regurgitation. Although TA was effective in preventing progression of TR, innovation is needed to identify ways to decrease PPM implantation rates.

Section snippets

Study Population and Interventions

The study population included 401 patients enrolled in a randomized trial evaluating the additional use of concomitant TA in patients with moderate or less TR who underwent MVS for severe degenerative disease. The trial is registered at ClinicalTrials.gov (NCT02675244). The institutional review board at each center approved the protocol, and all patients provided written informed consent. The primary objective of the trial was to evaluate the safety and effectiveness of concomitant TA; the

Incidence, Timing, and Indication for PPM Implantation

A total of 401 patients with severe degenerative MR and moderate or less TR (with annular dilation) were randomized to receive MVS with (n = 198) or without TA (n = 203). Two patients were excluded from this analysis because of having a PPM at baseline (Figure E1). A PPM was implanted in 9.6% (95% CI, 6.8%-13.0%; n = 36/375) of patients within 2 years of randomization, with a PPM incidence of 16.0% (n = 30/187) among those randomized to MVS + TA and an incidence of 3.2% (n = 6/188) among those

Discussion

In the present analysis, we observed that 16% of patients who underwent MVS plus TA experienced conduction abnormalities that led to PPM implantation within 2 years, compared with only 3% of patients who underwent MVS alone. Among patients who received a PPM within the first 30 days after surgery, age and TA were the only independent risk factors. Extending the analysis period to 2 years, TA, age, and baseline LVEF were independently associated with PPM insertion, with TA being the dominant

Conclusions

Additional use of TA for moderate or less TR with annular dilation at time of MVS for degenerative MR was associated with a 6-fold greater risk of PPM compared with MVS alone. Risk factors for PPM implantation within 2 years after surgery included age, LVEF, and TA. For any given patient, the benefit of mitigating late progression of TR must be weighed against the risks of PPM. Optimal clinical decision-making requires insights into the long-term consequences of progressive TR and the clinical

Cited by (0)

The Tricuspid Repair trial was supported by a cooperative agreement (U01 HL088942) funded by the National Heart, Lung, and Blood Institute, Bethesda, MD, and a grant from the German Centre for Cardiovascular Research, Berlin, Germany. The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute, National Institutes of Health, the United States Department of Health and Human Services, or the German Centre for Cardiovascular Research.

A complete list of members of the trial is provided in the Appendix E1.

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