The latest findings on tricuspid valve interventions have sparked a wave of reassurance, yet they also leave us with lingering questions. This is a critical juncture in the medical field, and we must delve deeper to fully understand the implications.
The Tricuspid Valve Intervention Debate: A Reassurance, or a Cause for Concern?
Dharam Kumbhani, MD, from UT Southwestern Medical Center, believes these new real-world and extended trial data presented at TCT 2025 provide an "extension" from the pivotal trials. However, he emphasizes that only long-term follow-up will truly answer the questions surrounding safety and efficacy.
Let's take a closer look at the data presented by Rahul Sharma, MBBS, from Stanford University, and Jonathan G. Schwartz, MD, from Sanger Heart and Vascular Institute - Atrium Health.
Sharma presented data on the Evoque system, showing a 30-day all-cause mortality rate of 3.1% among over 1,000 patients. Major bleeding and new pacemaker rates were 1.3% and 14.9%, respectively. These results confirm the clinical benefits and improved quality of life for a diverse patient population.
Schwartz, on the other hand, presented 30-day data from over 800 patients enrolled in the TRILUMINATE trial, showcasing an impressive all-cause mortality rate of just 0.5%. Major bleeding occurred in 3%, and new pacemakers were required in only 0.2% of cases.
But here's where it gets controversial...
Despite these positive findings, some experts question the widespread use of these interventions. The approval of the TriClip device for tricuspid transcatheter edge-to-edge repair (T-TEER) and the Evoque device for transcatheter tricuspid valve replacement (TTVR) by the US FDA in 2024 was based on the results of the TRILUMINATE Pivotal and TRISCEND II trials. While these interventions have shown an impact on health status, they have yet to prove a reduction in harder clinical endpoints, such as hospitalizations for heart failure and mortality.
This has led to a debate among medical professionals. Should these interventions be more widely adopted in clinical practice?
Kumbhani believes the data provides reassurance, stating, "I think this provides very reassuring data that the way it’s being rolled out seems to be along the lines that one would’ve envisioned."
However, he also acknowledges the need for long-term data to truly understand the outcomes.
The new results presented at TCT show an improvement from the initial trials, with cardiovascular mortality at 30 days reduced to 2.0% for Evoque and 0.6% for TRILUMINATE.
The STS/ACC TVT Registry results for Evoque included 1,034 patients with a mean age of 77.1 years, and a similar proportion of patients with primary and secondary TR. Almost half had been hospitalized for heart failure in the past year. The median procedure time was 103 minutes, and device implant success was high at 98.4%.
At 30 days, cardiovascular mortality accounted for most fatalities, and the rate of major or life-threatening bleeding was lower than expected. Sharma noted that the criteria for bleeding through the registry was more stringent, suggesting the results are even better than the numbers indicate.
The TRILUMINATE study included 847 patients with an attempted TriClip implantation, with a mean age of 79 years. Implant success was 98.7%, and most patients had functional TR.
Schwartz described the results as "very reassuring," with 82% of patients having moderate or less TR at 30 days. Additionally, the KCCQ improved by 17 points over the same time frame. Major adverse events were minimal, with a 30-day rate of 0.6%.
And this is the part most people miss...
While the data is promising, there are still concerns. Azeem Latib, MD, from Montefiore Medical Center, worries about underreporting, especially regarding new pacemakers and bleeding. He believes these new data set a higher standard and may lead to a reevaluation of treatment algorithms for patients with tricuspid regurgitation.
Additionally, Latib highlights the need for more information on thrombosis, which he believes could be the Achilles' heel of valve replacement.
As for the decision-making process between T-TEER and TTVR, Schwartz suggests that screening for TriClip first, followed by Evoque if patients are not candidates, is a common approach. However, he emphasizes the importance of quality imaging and dedicated structuralists in this conversation.
The debate continues, and we invite you to share your thoughts and opinions in the comments. Do you think these interventions should be more widely adopted? What are your concerns or considerations? Let's discuss and explore the potential of these tricuspid valve interventions together.
