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TRI-REPAIR: Valve reconstruction improves 6-month outcomes for tricuspid regurgitation
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The use of a transcatheter tricuspid valve reconstruction system in patients with symptomatic and moderate-to-severe functional tricuspid regurgitation safely reduced tricuspid regurgitation through decrease in annular dimensions, according to a study published in the Journal of the American College of Cardiology.
The reduction in tricuspid regurgitation contributed to better quality of life and symptom relief, the researchers wrote.
“The study provided valuable learnings that will help improve the safety and performance of the device (Cardioband Transcatheter System, Edwards Lifesciences) in the future, and sets the stage for further larger-scale trials to explore the potential impact of annual reduction on morbidity and mortality in patients experiencing moderate to severe TR,” Georg Nickenig, MD, professor and chair of the department of internal medicine at University of Bonn in Germany, and colleagues wrote.
In this single-arm, prospective trial, researchers analyzed data from 30 patients (mean age, 75 years; 73% women) from eight European centers with moderate-to-severe tricuspid regurgitation who were stable on medical treatment and were excluded from surgery by a local heart team. Transthoracic and transesophageal echocardiography and cardiac CTA were performed to determine the anatomical feasibility for implantation of the device.
The primary performance endpoint was successful deployment, access and positioning of the implant and septolateral annual diameter reduction at the end of the procedure and at hospital discharge. The primary safety endpoint was the overall rate of major serious adverse events, defined as a composite endpoint of MI, death, device-related cardiac surgery, cardiac tamponade and stroke, and serious adverse device effects 30 days after the procedure.
Of the patients in the study, 23% had ischemic heart disease and 83.3% were in NYHA functional class III to IV at baseline. The mean left ventricular ejection fraction was 57.5%.
The primary performance endpoint was met by 100% of patients. Three patients died during the 6 months after the procedure.
Improvement in outcomes
There was an average reduction of 9% for the annual septolateral diameter between baseline and 6 months (41.6 mm to 37.8 mm; P = .0014). Reductions were also seen in mean vena contracta width (1.2 cm to 0.9 cm; P < .0001) and proximal isovelocity surface area effective regurgitant orifice area (0.8 cm2 to 0.4 cm2; P < .01).
At 6 months, 76% of patients improved by at least one NYHA class, with the majority of patients (88%) in class I or II. Six-minute walk distance increased from 266 m at baseline to 326 m at 6 months (P < .01), and the Kansas City Cardiomyopathy Questionnaire score improved from 46 to 70 (P < .01).
“It may be argued that these patients have already been at a late stage of the disease and that long-term benefit may be uncertain,” Nickenig and colleagues wrote. “However, despite the inclusion of such patients, the overall results of the study are very promising, showing a significant reduction of all accepted echocardiography parameters defining TR severity.”
Countermeasures needed
More research is needed despite the fact that the results show the potential of this device.
“Clearly more information is needed,” Jeffrey S. Borer, MD, FACC, FAHA, professor of medicine, cell biology, radiology and surgery and director of The Howard Gilman Institute for Heart Valve Disease and the Schiavone Institute for Cardiovascular Translational Research at SUNY Downstate Medical Center in Brooklyn, New York, wrote in a related editorial. “As TR becomes ever more prevalent and its predictive value for late outcomes increases, a basis for selection of preventive countermeasures is more urgently required.” – by Darlene Dobkowski
Disclosures: The study was sponsored by Edwards Lifesciences. Nickenig reports he has financial ties with multiple pharmaceutical and device companies, including Edwards Lifesciences. Borer reports he served as a consultant for AstraZeneca, BioMarin, CellAegis, ECG, GlaxoSmithKline, Novartis, Servier and Takeda. Please see the study for all other authors’ relevant financial disclosures.
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