Cardiothoracic Surgical Trials Network: Concomitant Tricuspid Valve Repair + Mitral Valve Surgery vs. Mitral Valve Surgery Alone - CTCR-MVS
Contribution To Literature:
The CTCR-MVS trial demonstrated that concomitant tricuspid valve repair at the time of mitral valve surgery among patients with less than severe TR at baseline results in improved outcomes at 2 years, primarily in reducing the progression to worse/severe TR; mortality and readmissions were similar.
Description:
The goal of the trial was to evaluate the safety and efficacy of concomitant tricuspid valve repair among patients with less than severe tricuspid regurgitation (TR) who were undergoing mitral valve surgery.
Study Design
All patients were randomized in a 1:1 open-label fashion to either concomitant mitral valve surgery + tricuspid valve repair (n = 198) or mitral valve surgery alone (n = 203). Tricuspid valve repair was performed using an undersized (26-30) rigid nonplanar annuloplasty band.
- Total number screened: 5,208
- Total number of enrollees: 401
- Duration of follow-up: 24 months
- Mean patient age: 67 years
- Percentage female: 25%
Inclusion criteria:
- Mitral valve surgery for degenerative mitral regurgitation (MR) with moderate TR
- None/trace or mild TR with tricuspid annular dilation (≥40 mm or index: ≥21 mm/m2 body surface area)
Exclusion criteria:
- Primary tricuspid valve disease
- Secondary MR
- Suboptimal volume management
Other salient features/characteristics:
- Left ventricular ejection fraction: 64%
- Atrial fibrillation: 44%
- Moderate TR at baseline: 37.5%
- Normal right ventricular function: 90%
- Mitral valve repair: 89%
- Sternotomy: 52%
Principal Findings:
The primary outcome, major adverse cardiac events at 2 years (death, tricuspid valve reoperation, TR progression by at least 2 grades) for mitral valve surgery + tricuspid valve repair vs. mitral valve surgery alone: 3.9% vs. 10.2% (relative risk 0.37, 95% confidence interval 0.16-0.86, p = 0.02).
- Death: 3.2% vs. 4.5%
- Tricuspid valve reoperation: 0
- Progression of TR: 0.6% vs. 6.1% (p < 0.05)
Among patients with moderate TR at baseline:
- Primary outcome: 4.5% vs. 18.1%,
Secondary outcomes for mitral valve surgery + tricuspid valve repair vs. mitral valve surgery alone:
- Severe TR at 2 years: 0.6% vs. 5.6% (p < 0.05)
- Permanent pacemaker implantation: 14.1% vs. 2.5% (p < 0.05)
- Ischemic stroke: 4.5% vs. 1.5% (p > 0.05)
- No difference in rehospitalizations or quality of life
Interpretation:
The results of this trial indicate that concomitant tricuspid valve repair at the time of mitral valve surgery among patients with < severe TR at baseline results in improved outcomes at 2 years, primarily in reducing the progression to worse/severe TR. Endpoints such as mortality, readmission were similar, while permanent pacemaker implantation was higher with concomitant tricuspid valve repair.
These are interesting findings. Also, only a third of these patients even had moderate TR at baseline; others had much less TR but were included due to tricuspid valve annular dilation. Since secondary MR patients were excluded (unclear if this meant all Carpentier classes of secondary MR or class I – ventricular functional MR – alone), these findings may be applicable to a smaller patient population. Indeed, in this trial, <10% of screened patients could be included, although the exact reasons for exclusion were not well described. Based on these results, it remains unclear if TR progression alone can be a reason for advocating for this approach, more so since the permanent pacemaker implantation rate was 5-fold higher. Over the long-term, this can result in lead-related TR and thus potentially nullify these benefits. Longer-term follow-up is planned and will be instructive.
References:
Gammie JS, Chu MW, Falk V, et al., on behalf of the CTSN Investigators. Concomitant Tricuspid Repair in Patients With Degenerative Mitral Regurgitation. N Engl J Med 2022;386:327-39.
Editorial: Chikwe J, Gaudino M. The Price of Freedom From Tricuspid Regurgitation. N Engl J Med 2022;386:389-90.
Presented by Dr. James S. Gammie at the American Heart Association Virtual Annual Scientific Sessions (AHA 2021), November 13, 2021.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Mitral Regurgitation
Keywords: AHA Annual Scientific Sessions, AHA21, Atrial Fibrillation, Cardiac Surgical Procedures, Heart Valve Diseases, Ischemic Stroke, Mitral Valve Insufficiency, Pacemaker, Artificial, Patient Readmission, Quality of Life, Reoperation, Tricuspid Valve Insufficiency
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