Transcatheter treatment of tricuspid regurgitation (TR) with the TriClip device was shown to be safe and effective, with substantial improvement in 1-year clinical outcomes, in an early feasibility study funded by the device’s manufacturer, Abbott.
However, the results of the single-arm TRILUMINATE trial in 85 patients – 62 of whom were evaluable at 1 year – may not be generalizable to patients with heart failure and reduced ejection fraction because it included “few patients” with reduced left ventricular (LV) systolic function, the researchers said.
It was also not a randomized controlled trial, so results should be “interpreted with caution,” they warned, adding that the early stage of this therapy means a “steep learning curve.”
The findings were published in the Jan. 26 issue of the Journal of the American College of Cardiology. The manuscript’s lead author was Philipp Lurz, MD, PhD, from the University of Leipzig, Germany.
There are growing concerns over TR as a relevant and increasing public health concern, not just as a surrogate for more advanced cardiac disease, but as a condition with independent prognostic implications, the researchers said. They cited research showing that worsening TR disease is associated with a progressive increase in mortality.
Isolated tricuspid valve surgery has returned unsatisfactory results, however, with a peri-operative mortality rate of 8% to 10%, they said, meaning surgery is often withheld from TR patients.
Instead, minimally invasive transcatheter techniques have been used for TR and shown promise, they said, but added that because most transcatheter tricuspid valve repair (TTVR) approaches are still in development, robust acute or longer follow-up data are “lacking.”
The study’s aim was, therefore, to assess 1-year outcomes with the TriClip TTVR system, including repair durability, clinical benefit and safety.
TRILUMINATE ran with a single arm across 21 sites in Europe and the U.S., including 85 symptomatic patients at high surgical risk with moderate or greater TR as measured by transthoracic and transesophageal echocardiography and no indications for left-sided or pulmonary valve correction.
Outcomes including TR severity were measured at 1 year for 62 of the patients, with 22 missing, due to death (n = 7), withdrawal (n = 5), missed visits (n = 4) and lack of readable echocardiographic data for assessment (n = 6).
New York Heart Association (NYHA) classification, 6-minute walk test and Kansas City Cardiomyopathy Questionnaire (KCCQ) score were measured.
Major adverse events (MAE) were also recorded; these included cardiovascular mortality, myocardial infarction, stroke, new-onset renal failure, endocarditis requiring surgery, and nonelective cardiovascular surgery for tricuspid valve repair system-related adverse events, which were adjudicated by an independent events committee.
Safety endpoints included major bleeding, new-onset liver failure and hospitalizations.
At 1 year, 70% (44 of 63) of the patients had moderate or less TR, compared to 8% at baseline and 60% at 30 days. The TriClip TTVR was found to be durable, with 87% (54 out of 62) of the subjects seeing sustained TR reduction of more than 1 grade at 1 year.
However, the more severe the patient’s TR, the less likely the patient was to achieve a moderate or less TR rating at 1 year.
“In this cohort, multivariate logistic regression indicated baseline TR severity as the only significant predictor for achieving moderate or less TR at 1 year,” the researchers said.
“Importantly, 56% (22 of 39) of subjects with baseline massive or torrential TR achieved moderate or less TR at 1 year, with 90% (35 of 39) achieving at least a 1-grade reduction in TR.”
The researchers also marked significant clinical improvements in NYHA functional class I/II (31% to 83%), 6-minute walk test (272.3 ± 15.6 to 303.2 ± 15.6 meters) and KCCQ score (improvement of 20 ± 2.61 points).
Significant reverse right ventricular (RV) remodeling was observed in terms of size and function.
The overall major adverse event rate and all-cause mortality were both 7.1%.
The results should spark additional randomized trials to compare long-term clinical outcomes of catheter-based intervention with optimum medical therapy, the researchers said, despite some limitations.
Still, the results were hailed as “pretty exciting” in an accompanying editorial led by Erwan Donal, MD, PhD, from the University of Rennes, France – who together with a fellow editorialist has received consultant fees from Abbott.
“They not only show a sustained reduction in TR severity between 30 days and 1 year after TTVR, but also, a decrease in right ventricular (RV) dimensions and, more importantly, a clinical benefit,” the editorialists said.
In particular, the finding that progressive late right heart reverse anatomic and functional remodeling can occur should be confirmed with a detail multiparametric analysis of RV shape, size, and functions, they said.
“RV dysfunction (with liver, renal, and hemostatic consequences) is definitely a matter of concern for our fragile patients with TR,” they said. “Many patients undergoing TTVR today present already with a reduced RV function.”
Besides being a manufacturer-funded study, the authors disclosed other industry links, with various researchers having been consultants or received fees from Abbott, Edwards Lifesciences and Medtronic, a host of large pharmaceutical companies and other sources.
Lurz P, von Bardeleben RS, Weber M, et al. Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation. J Am Coll Cardiol 2021;77:229-39.
Donal E, Leurent G, Iung B. Are We Right to Believe in the Value of Transcatheter Treatment of Secondary Tricuspid Regurgitation? J Am Coll Cardiol 2021;77:240-2.