Real-World Data Confirms Safety and Efficacy of Transcatheter Tricuspid Valve Interventions

Proponents of transcatheter tricuspid valve interventions for severe tricuspid regurgitation (搜索)搜索该疾病 gained new confidence from real-world and extended trial data presented at TCT 2025 in San Francisco, though questions about long-term outcomes persist.

Evoque Registry Shows Strong Real-World Performance

Rahul Sharma, MBBS, from Stanford University查看公司主页 presented data from the STS/ACC TVT Registry on the Evoque (搜索)搜索该药品 transcatheter tricuspid valve replacement system, encompassing 1,034 patients (mean age 77.1 years; 69.1% female) who underwent attempted implantation between February and March 2025.

The registry demonstrated a 30-day all-cause mortality rate of 3.1%, with cardiovascular mortality accounting for 2.0% of fatalities. Major bleeding occurred in 1.3% of patients, while new pacemaker requirements reached 14.9%. Device implant success was achieved in 98.4% of cases, with only eight patients (0.8%) requiring conversion to surgery.

"The first US real-world experience confirms the clinical and quality-of-life benefits of the Evoque (搜索)搜索该药品 system across a broad patient population treated at multiple centers," Sharma said.

The patient population included similar proportions with primary (41.2%) and secondary tricuspid regurgitation (搜索)搜索该疾病 (43.2%), while 9.4% had pacemaker-induced TR. Nearly half (48.4%) had been hospitalized for heart failure (搜索)搜索该疾病 in the past year. Median procedure time was 103 minutes, with most patients discharged home (93.8%) after a median hospital stay of 2 days.

Significant improvements in tricuspid regurgitation (搜索)搜索该疾病 reduction were observed, with 97.7% of patients achieving mild or lower TR by 30 days. Right ventricular remodeling showed positive changes, including improvement in end-diastolic mid RV diameter (3.9 vs 3.6 cm; P = 0.003) and RV systolic pressure (41.1 vs 33.8 mm Hg; P < 0.001).

TRILUMINATE Data Reinforces TriClip Safety

Jonathan G. Schwartz, MD, from Sanger Heart and Vascular Institute (搜索)搜索该词条 presented 30-day data from 847 patients enrolled in the TRILUMINATE pivotal trial and continued access study. The cohort included patients from the randomized trial device arm (285), single-arm trial (200), and continued access study (412).

The all-cause mortality rate was remarkably low at 0.5%, with major bleeding occurring in 3% of patients and new pacemaker requirements in only 0.2%. Implant success reached 98.7%, with a mean of two clips used per patient and a mean procedure time of 146 minutes.

"This is the largest analysis of early T-TEER experience to date," Schwartz said. "TriClip (搜索)搜索该药品 is very safe and effective with a significant improvement in quality of life at 30 days with very low rates of mortality, heart failure (搜索)搜索该疾病 hospitalization, bleeding, conduction disturbances, or device thrombosis."

At 30 days, 82% of patients achieved moderate or less tricuspid regurgitation (搜索)搜索该疾病 (P < 0.001), while Kansas City Cardiomyopathy Questionnaire scores improved by 17 points (P < 0.001). Major adverse events occurred in only 0.6% of patients at 30 days, including 0.4% cardiovascular mortality and 0.2% new-onset renal failure.

Improved Safety Profiles Over Pivotal Trials

The new results represent improvements from the initial trials, where cardiovascular mortality at 30 days was 3.2% in TRISCEND II and 0.6% in TRILUMINATE. The reduced bleeding rates in the Evoque (搜索)搜索该药品 registry were particularly notable, with Sharma noting that registry bleeding criteria were "much more stringent than the MVARC criteria."

"It's also important to point out that the criteria for bleeding through the registry was much more stringent than the MVARC criteria," Sharma noted. "So, in addition to these being numerically lower than what we saw in TRISCEND II, this is a more inclusive definition. I think those results are even better than what the numbers suggest."

Clinical Decision-Making and Future Directions

The choice between transcatheter tricuspid edge-to-edge repair (T-TEER) with TriClip (搜索)搜索该药品 and transcatheter tricuspid valve replacement (TTVR) with Evoque (搜索)搜索该药品 remains institution-dependent. Schwartz indicated his center first screens for TriClip eligibility, which fits 75-80% of their population, before considering Evoque for non-candidates.

"What both of these studies provide is an extension of what we saw from the pivotal trials," said Dharam Kumbhani, MD, from UT Southwestern Medical Center (搜索)搜索该词条. "We continue to see safety, [and] we continue to see efficacy in the real world as well as with continued access in a much larger cohort of patients."

However, both interventions have demonstrated effects on health status without yet showing reduction in harder clinical endpoints such as heart failure (搜索)搜索该疾病 hospitalizations and mortality. Long-term follow-up data will be crucial for determining the ultimate clinical value of these technologies.

Azeem Latib, MD, from Montefiore Medical Center查看公司主页, emphasized the need for more information on thrombosis, particularly for valve replacement. "To me, that's going to be the Achilles' heel of valve replacement [and] figuring that out. And maybe we can fix it, but we need to know more about it," he stressed.