Tricuspid Valve Repair Finally Proven to Keep HF Events At Bay

Transcatheter tricuspid valve repair could finally be tied to improved hard outcomes in people with severe tricuspid regurgitation (TR) at high risk for future heart failure (HF) events, a German trial found.

With operators using commercially available transcatheter devices, patients had 1-year results well surpassing expectations for reduced all-cause death and hospitalization for HF with improved quality of life (win ratio 2.42 over medical therapy alone, 95% CI 1.76-3.33), according to Jörg Hausleiter, MD, of Ludwig-Maximilians-Universität München, Germany.

Taking quality of life out of the equation, combined death from any cause and HF hospitalization at 3 years still significantly favored transcatheter repair for patients with symptomatic severe TR (52.4% with tricuspid repair vs 21.0% with medical therapy, HR 0.40, 95% CI 0.29-0.55).

Hausleiter presented the TRIC-I-HF trial results at the European Society of Cardiology (ESC) Congress in Munich, Germany, with a simultaneous publication in the New England Journal of Medicine.

“These findings extend previous evidence from randomized trials by showing that the benefits of an interventional strategy were not confined to improvements in quality of life but also translated into meaningful differences in hard clinical outcomes,” study authors wrote. “The findings also showed the procedural safety as well as the sustained reduction in the severity of tricuspid regurgitation when transcatheter tricuspid-valve repair is performed at experienced heart-valve centers.”

Notably, TRIC-I-HF showed that the number needed to treat to prevent one death or HF hospitalization at 1 year was just four patients in the hands of these experienced operators in Germany.

“It’s just an incredible result,” said ESC session discussant Rebecca Hahn, MD, of Columbia University Medical Center in New York City.

“This is a landmark study that will inform patients and clinicians about the benefit of transcatheter repair therapy. I congratulate the … investigators in proving for once and for all that TR reduction can result in a mortality and heart failure hospitalization benefit. And we eagerly look forward to subgroup analyzes that may further inform clinicians about who, when, and how to treat,” Hahn told the audience.

Hausleiter and colleagues reported that tricuspid repair led to an early HF hospitalization benefit — apparent as early as 1.6 years on average — that continued to diverge over time.

As for why TRIC-I-HF was so successful, the investigators cited the sicker patient population of this trial as well as increasing operator experience in the real world.

“Owing to the marked anatomic variability of the tricuspid valve, the challenges of grasping thin leaflets in the presence of large coaptation gaps, and the complexity of intraprocedural echocardiographic imaging, transcatheter tricuspid valve repair remains a technically demanding procedure with a pronounced volume-outcome relationship,” Hausleiter’s group wrote.

TRIC-I-HF was conducted at 29 high-volume heart-valve centers in Germany. Participants were 360 patients with symptomatic severe TR randomized 2:1 to tricuspid valve repair or medical therapy alone (mean age 80.3, 56.4% women).

At baseline, tricuspid regurgitation was graded as severe in 50.8% of the cohort, massive in 34.2%, and torrential in 10.3%. Average left ventricular ejection fraction was 54.3%. Three in four people had New York Heart Association class III or IV HF; 55.0% had been hospitalized for HF in year preceding enrollment.

Of those who got transcatheter tricuspid intervention, 98.3% underwent transcatheter edge-to-edge repair (TEER). TEER largely involved the available CE-marked Pascal (65.6%) and TriClip systems (33.0%).

The investigators allowed crossovers only after the occurrence of severe HF decompensation resulting in hospitalization and IV diuretic therapy. In 28 of 48 crossovers, valve repair was performed during the hospitalization that constituted the primary endpoint event, whereas the remaining crossovers involved repair performed during subsequent hospitalizations.

Major adverse events within 30 days occurred in 5.9% of cases after tricuspid transcatheter valve repair.

TRIC-I-HF’s results may not necessarily be generalizable to other countries, the trialists acknowledged.

Nonetheless, Hausleiter noted that even a boost in quality of life alone is still meaningful and should not be taken for granted in TR.

“For the patients, probably for most of them, the quality of life improvement matters more than than an increased lifespan because they’re usually already around 80 years of age,” he said during a press conference. “Quality of life is important, but also the impact of healthcare hospitalizations and mortality reduction will probably provide us with more arguments to treat more patients with such a therapy.”