TriValve: a propensity score-matched analysis of transcatheter tricuspid valve treatment vs. medical treatment in patients with severe tricuspid regurgitation
Reported from the TCT Congress 2019 in San Francisco - USA
At TCT 2019 in San Francisco - USA, Maurizio Taramasso presented the results of the TriValve Registry. Read the summary and analysis by Tom Cahill.
The methodology
Significant tricuspid regurgitation (TR) is associated with symptoms, heart failure (HF) and increased mortality. Although a range of transcatheter devices has emerged for treatment of TR, it is unknown whether correction of TR improves patients’ clinical outcome.
The TriValve Registry enrolled patients with severe, symptomatic TR undergoing transcatheter tricuspid intervention (TTVI) with a range of devices across 22 centres in Europe and the US. Transcatheter therapies included MitraClip, FORMA, Cardioband, TriCinch, Trialign, caval valve implantation, PASCAL and NaviGate. The outcome from these patients was compared with a propensity-matched cohort with severe TR treated with medical therapy alone. The primary endpoint was mortality from any cause or hospitalization for HF.
What were the results?
472 patients were included in TriValve, with a mean age of 77±8 years. 55% were women, and TR was functional in 90%. 34% had right ventricular (RV) dysfunction and 93% had NYHA class III-IV symptoms. 33% had co-existent mitral regurgitation (MR) > 2+ in severity. After propensity score matching, there were 268 patients in each of the TTVI and medical therapy arms. Despite matching, there were significant residual differences between the groups, with the TTVI cohort being more symptomatic and a higher proportion having right ventricular (RV) dysfunction, co-existent MR, atrial fibrillation, and a pacemaker or defibrillator.
The headline finding was that at 12 months survival was higher in patients who had undergone TTVI, at 77±3% compared to 64±3% in those receiving medical therapy (P = 0.0009). Freedom from HF hospitalization was 68±4% for TTVI patients and 51±3% for the medical therapy cohort (P = 0.0003). The unadjusted hazard ratio for the primary composite endpoint of death or HF hospitalization was 0.60 (95% CI 0.46-0.79, P = 0.003), which remained significant after adjustment for sex, NYHA class, atrial fibrillation, RV dysfunction, mitral regurgitation, and presence of a PPM/defibrillator (hazard ratio 0.35, 95% CI 0.23-0.54, P < 0.0001).
My take on this study
This study is important as it provides the first evidence to date that transcatheter correction of TR is associated with improved clinical outcomes – including mortality – compared to medical therapy alone.
There are limitations: these are observational data, and although the study adjusts for differences between the groups, there may be residual confounding. The medical therapy cohort received heterogeneous, non-standardized treatment, and some of the TTVI population had concomitant treatment of MR in addition to TR. TriValve provides a strong impetus to drive future research on TTVI to treat TR, and sets the stage for ongoing and future RCTs, such as the TRILUMINATE Pivotal study of the TriClip device. The results from TriValve will raise the hope that TTVI will improve not just symptoms but also show prognostic benefit in the more rigorous setting of a RCT.
Find out more about this subject at PCR London Valves 2019:
To learn more about this subject, attend the following sessions at PCR London Valves 2019:
- Applied Learning: new transcatheter approaches to the tricuspid valve
- Case-based learning for the Heart Team: patient selection for tricuspid valve interventions
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