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Novel transcatheter device shows promise for severe tricuspid regurgitation
Implantation of a new transcatheter coaptation system in high-risk patients with severe tricuspid regurgitation was feasible and safe and yielded improvements in clinical outcomes, researchers reported in JACC: Cardiovascular Interventions.
At three sites in Canada and Switzerland, the Forma system (Edwards Lifesciences) was implanted in 18 patients with high risk for surgery, as determined by a EuroSCORE II of 9.1. The mean age was 76 years and 72% were women. Multimodality imaging and hemodynamic and clinical assessments were used to evaluate procedural, 30-day and 1-year outcomes.
Procedural success was achieved in 16 patients (89%), according to the results. In the two procedures deemed unsuccessful, one patient’s device dislocated into the right atrium and the second patient required open surgery due to perforation of the right ventricle.
At 1 year, no deaths, significant arrhythmias and device infections or dislocations occurred, but one patient was diagnosed with thrombosis of the device at 4 months after the procedure and one patient was rehospitalized for HF.
Clinical improvements were also observed. At 1 year, 11 of 14 patients (79%) with devices in place were in NYHA functional class I/II (P < .001). Furthermore, results revealed an 84-m increase in the average 6-minute-walk test (P = .03) and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire HF score (P = .02), as compared with baseline.
In 17 of 18 patients (94%), according to echocardiography, tricuspid regurgitation was reduced from severe at baseline to moderate-severe or less in 11 of 16 patients (69%) by 30 days and in 6 of 13 patients (46%) by 1 year (P = .01). Additionally, at 1 year, the diameter of the tricuspid annulus decreased from 45.7 mm to 42.1 mm (P = .004) and the diameter of the right ventricle decreased from 54 mm to 49.9 mm (P = .02).
“Despite encouraging 1-year data of the early Forma experience, several questions remain,” Mackram F. Eleid, MD, assistant professor of medicine at the Mayo Clinic, Rochester, Minnesota, wrote in an accompanying editorial.
For instance, limitations of color Doppler assessment of tricuspid regurgitation after device implantation necessitates the need for alternative techniques to assess procedural results, Eleid noted. Questions also persist about whether preprocedural data can identify patients who would benefit most from tricuspid valve repair, what outcomes should be used to gauge success and whether improvements in the device design and procedural techniques can reduce risks and improve success.
“Continued work in the U.S. Early Feasibility Trial (ClinicalTrials.gov identifier NCT02471807) and SPACER (Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TraAnsCatheter REpaiR System) trials (ClinicalTrials.gov identifier NCT02787408) will provide further insight into these important questions,” Eleid wrote.
“The important data gained from these studies will inform the design of a pivotal randomized controlled trial that better measures the benefit of this exciting new therapy, which promises to open a new door for patients with severe secondary [tricuspid regurgitation].” – by Melissa Foster
Disclosures: Eleid reports no relevant financial disclosures. Please see the full study for a list of the authors’ relevant financial disclosures.