Data from two new studies suggest that transcatheter tricuspid valve repair (TTVr) is a safe and effective treatment option for patients with symptomatic or severe tricuspid regurgitation (TR) who are not suitable for surgery. Both were published in JACC: Cardiovascular Interventions.
Lluis Asmarats, Josep Rodés-Cabau (Quebec Heart and Lung Institute, Laval University, Quebec City, Canada) et al reported long-term outcomes from the first-in-human experience of the FORMA transcatheter tricuspid valve repair system (Edwards Lifesciences) for the treatment of severe tricuspid regurgitation. They found that FORMA was safe and feasible, with low device-related complications, moderate TR reduction, and significant improvements in heart failure symptoms and quality of life up to three years.
FORMA is a coaptation transcatheter tricuspid valve repair device designed to increase the leaflet coaptation surface by occupying the regurgitant orifice area. Short- and mid-term results have previously been reported, but data beyond one year are scarce. Asmarats, Rodés-Cabau et al evaluated the safety, efficacy, and clinical outcomes at two years and beyond following TTVr with the FORMA repair system.
Participants underwent TTVr with the FORMA system at four centres in Europe and Canada under a compassionate clinical use programme, with data collected at baseline, 30 days, and one year, and yearly thereafter.
Procedural success was defined as successful device implantation in the absence of major device- or procedure-related serious adverse events, and was achieved in 17 (89%) of the 19 patients (mean age 76±9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2±5.6%) included in the study; there were no cases of 30-day mortality.
At a median follow-up of 32 months, four (24%) patients had died (three from terminal heart failure, one from sepsis) and three (18%) patients required rehospitalisation for heart failure. There was one device-related thrombosis and one pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation.
At follow-up of two–three years, less than severe TR was observed on echocardiography in 67% of patients. And compared with baseline, significant improvements in NYHA class (p<0.001), six-minute walk test (+54 metres, p=0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points, p=0.016) were found in 15 successfully implanted patients at follow up of at least 24-months.
The authors conclude: “TTVr using the FORMA system showed a favourable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to three years.” They acknowledged the sample size was small, and that the study was limited to one specific type of transcatheter tricuspid valve intervention, preventing the results from being generalisable to other therapies.
They add: “Further prospective studies are needed to confirm these results and better identify which patients should be offered the FORMA system in the future.”
In a separate study, Michael Mehr, Jörg Hausleiter (Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany) et al announced results from the TriValve (Transcatheter Tricuspid Valve Therapies) Registry on one year outcomes after edge-to-edge valve repair for symptomatic tricuspid regurgitation.
All of the 249 patients (mean age 77±9 years, EuroSCORE II 6.4%) included in the multicentre international TriValve registry were symptomatic, with signs of right-sided or global heart failure. The majority were in New York Heart Association (NYHA) class III or IV, and were considered to be at high or prohibitive risk for surgery. Endpoints were defined as all-cause mortality and a composite of all-cause mortality and unplanned rehospitalisation for heart failure within 12 months after the procedure. Clinical and echocardiographic outcomes were collected prospectively and analysed retrospectively.
The procedure was successful in 77% of participants, with TR reduction to grade ≤2+ by placement of 2±1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At one-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and NYHA class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalisation for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of one-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm.
Mehr, Hausleiter and colleagues highlight the low rate of procedure-related events, pointing to a number of factors that should be taken into consideration: patients were multimorbid, frail, and treatable only in compassionate and/or off-label use programs; the limitations involved in steering an interventional device not optimised for the treatment of tricuspid disease; and the known challenges in echocardiographic visualisation of tricuspid leaflets for interventional edge-to-edge valve repair. They say the low adverse event rates are in line with published data,” indicating that tricuspid edge-to-edge repair is a safe therapeutic option in these patients”.
“Transcatheter tricuspid edge-to-edge valve repair is safe and results in durable TR reduction at one-year follow-up and is associated with significant clinical improvement. Further refinement in patient selection, imaging, device innovation, and operator experience may further improve procedural success and outcomes in this high-risk patient population”.