A transcatheter tricuspid valve repair system had a long-term safety profile in patients who were at high surgical risk, which led to sustained functional improvement and tricuspid regurgitation reduction for up to 3 years, according to a study published in JACC: Cardiovascular Interventions.
Functional tricuspid regurgitation
Lluis Asmarats, MD, of the department of cardiology at Quebec Heart and Lung Institute at Laval University in Quebec City, and colleagues analyzed data from 19 patients (mean age, 76 years; 74% women) with functional tricuspid regurgitation and high surgical risk. Patients underwent transcatheter tricuspid valve repair with a system (FORMA, Edwards Lifesciences).
“The device consists of a foam-filled balloon (spacer), which is advanced via the left subclavian or axillary vein through a 24F sheath and placed within the tricuspid annulus over a rail that is anchored into the base of the right ventricle,” Asmarats and colleagues wrote.
All patients underwent preprocedural workup including transesophageal echocardiography, transthoracic echocardiography and electrocardiography-synchronized multidetector cardiac CT.
Procedural success was defined as successful device implantation without major procedure- or device-related serious adverse events.
Patients underwent echocardiography and clinical assessment at 1 month, 1 year and annually thereafter. Blood testing, physical examination and transthoracic echocardiography were included in the clinical visits.
Procedural success was attained in 89% of patients with no cases of mortality at 30 days.
During a median follow-up of 32 months, 24% of patients died, 75% of which was associated with terminal HF and 25% associated with sepsis. HF hospitalization was required in 18% of patients.
One patient had device-related thrombosis 4 months after the procedure and another had pulmonary embolism 13 months after the procedure. Both instances were in the setting of subtherapeutic oral anticoagulation.
At 2-year and 3-year follow-up, 67% of patients had less than severe tricuspid regurgitation. Most patients (93%) had an improvement in NYHA functional class by at least one grade. The number of patients with NYHA class III or greater decreased from 93% to 34% (P < .001).
Kansas City Cardiomyopathy Questionnaire score improved by 16 points compared with baseline, and 6-minute walk test distance increased by 54 m (P for both = .016).
“Further prospective studies are needed to confirm these results and better identify which patients should be offered the FORMA system in the future,” Asmarats and colleagues wrote.
“This study has been conducted in a highly selected population of patients with isolated tricuspid regurgitation: Patients with biventricular failure have been excluded, and patients with previous tricuspid interventions,” Francesco Maisano, MD, head of cardiovascular surgery at Zurich University Hospital and full professor of cardiac surgery at University of Zurich, wrote in a related editorial. “Real-world patients are complex and the population undergoing tricuspid interventions today present with variable clinical scenarios; the applicability of the outcomes of device trials into real world need to be monitored by well-conducted registries.” – by Darlene Dobkowski
Disclosures: Asmarats reports he received a grant from the Fundación Alfonso
Martin Escudero. Maisano reports he received grant and/or research support from Abbott Vascular, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic and NVT; received consultant fees and honoraria from Abbott Vascular, Cardiovalve, Edwards Lifesciences, Magenta, Medtronic, Perifect, Transseptal Solutions and Xeltis; and received royalty income/IP rights/shares from 4Tech, Cardiovalve, Edwards Lifesciences, Perifect, Swissvortex and Transseptal Solutions. Please see the study for all other authors’ relevant financial disclosures.