New transcatheter devices show promise in severe secondary tricuspid regurgitation
Tricuspid valve therapy is a safe and feasible treatment alternative for patients with severe symptomatic tricuspid regurgitation, according to the results of two trials presented at TCT 2017.
The FORMA early feasibility and the TRI-REPAIR studies investigated the device performance of transcatheter therapy systems in patients with severe tricuspid regurgitation.
“Treatment alternatives for patients with severe symptomatic tricuspid regurgitation are limited. Medical therapy is often ineffective and surgery is associated with high operative mortality,” Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center at NewYork-Presbyterian Hospital, said during his presentation of the FORMA trial results. “Less-invasive transcatheter therapies designed to reduce tricuspid regurgitation offer the potential to improve clinical outcomes.”
FORMA t rial
To evaluate safety, performance and clinical outcomes at 30 days, Leon and colleagues conducted a single-arm, multicenter, prospective study at five sites across the U.S.
Patients were included in the study if they had severe secondary tricuspid regurgitation that required treatment, if they had persistent right HF despite optimal medial therapy, NYHA class II to IV or if they were at high surgical risk for tricuspid valve repair or replacement.
According to the presentation, 69% of patients were free from all-cause mortality, stroke, vascular injury, major bleeding, device-related cardiac surgery or acute kidney injury.
The results of the study showed that in patients with “torrential” tricuspid regurgitation, the Forma tricuspid valve therapy system (Edwards Lifesciences) was feasible, but it was also linked to infrequent distal anchor dislodgements and right ventricle perforations.
Leon also noted that there was a reduction in baseline tricuspid regurgitation at 30 days (1.1 ± 0.6 vs. 0.6 ± 0.4; P = .001).
Additionally, at 30 days, there was an improvement in NYHA functional class (84% vs. 28%; P = .0002), 6-minute walk tests (183 ± 96 vs. 221 ± 92; P = .012) and Kansas City Cardiomyopathy Questionnaire scores (39 ± 22 vs. 68 ± 21; P = .001).
According to Leon, next-generation Forma devices will be developed to prevent anchor dislodgement or right ventricle perforations.
“Longer-term follow-up is necessary to assess recurrence of tricuspid regurgitation, evidence of right ventricle remodeling and late clinical outcomes,” Leon said.
The single-arm, multicenter, prospective TRI-REPAIR study was conducted to evaluate the safety and performance of the Cardioband system (Edwards Lifesciences) for repair of tricuspid regurgitation.
The study had a primary safety endpoint of overall rate of major serious adverse events and serious device effects leading up to hospital discharge and postoperative 30 days.
The technical endpoint of the study was successful access, deployment, device positioning as well as septolateral reduction at intraprocedural and discharge.
According to results of the study presented by Georg Nickenig, MD, from the Heart Center at the University of Bonn in Germany, there was a 100% success rate in access, deployment and positioning of the Cardioband device.
At 30 days, there were two instances of death, one occurrence of stroke, three patients who experienced bleeding complications and no device-related cardiac surgery or renal failure.
The results of the study show that use of the Cardioband tricuspid valve therapy system was safe and effective in patients with severe secondary tricuspid regurgitation.
The researchers found reductions in tricuspid regurgitation despite a large portion of patients having torrential tricuspid regurgitation at baseline.
Improvements in functional status were also found.
According to Nickenig, longer study periods are necessary to improve on the limited data from the study. – by Dave Quaile
Reference s :
Leon MB. Late-Breaking Clinical Trials 3. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.
Nickenig G. Late-Breaking Clinical Trials 3. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2017; Denver.
Disclosure s : Leon reports he receives grant and research support from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic; consultant fees and honoraria from Abbott and Boston Scientific; and owns shares and equity in Cathworks, Claret, Elixir, GDS, Medinol, Mitralign and Valve Medical. Nickenig reports he has various financial ties with Abbott, AGA, AstraZeneca, Bayer, Berlin Chemei, Biosensus, Biotronic, BMS, Boehringer Ingelheim, Daiichi Sankyo, Edwards, Medtronic, Mitratech, Novartis, Pfizer, Sanofi Aventis and St. Jude.