The first patients to receive Edwards Lifesciences’ FORMA system to treat severe tricuspid regurgitation (TR) demonstrated significant clinical improvements one year after implantation, according to a study in JACC: Cardiovascular Interventions.
Of the 14 patients with successful device implantation and one-year follow-up, 11 improved to New York Heart Association functional class I or II, compared to just one patient in class II at baseline. The treated patients also averaged an 84-meter increase in a six-minute walk test and improved their scores on a heart failure questionnaire. Four participants (28 percent) showed evidence of significant reverse right ventricular (RV) remodeling.
“The main finding of our study is the significant clinical benefit derived from the reduction of TR and improvement of RV dimensions achieved with the FORMA system at 1 year of follow-up,” wrote Gidon Perlman, MD, with St. Paul’s Hospital in Vancouver, British Columbia, Canada, and colleagues.
“This favorable trend led to a reduction of the frequency of hospitalizations for heart failure and to improved functional measurements. The clinical benefit observed seems associated with the reduction in RA (right atrium) pressures and improvement in RV stroke volumes and forward flow.”
According to Edwards Lifescience, the FORMA system works “by occupying the regurgitant orifice area and providing a surface for the coaptation of the valve's native leaflets. The device consists of a foam-filled polymer balloon ‘spacer’ and a rail that is anchored at the right ventricular apex.”
Eighteen patients, averaging 76 years old, underwent device implantation at three centers in Canada and Switzerland. They were deemed inoperable due to high surgical risk.
Procedural success was achieved in 16 patients (89 percent), with one failure resulting from device dislocation and the other from RV perforation, requiring emergency sternotomy.
The researchers noted greater clinical improvements in earlier stages of follow-up. Sixty-nine percent had TR of moderate-severe or less at 30 days versus 46 percent at one year.
“Short-term results at 30 days seemed more favorable, whereas some patients showed recurrence of severe TR after 1 year,” Perlman and colleagues noted. “This might be a result of alterations in the interaction of the FORMA device with the tricuspid leaflets because of changes in relative positioning of the spacer, or because of progressive continued dilatation of the RV annulus.”
Because the participating centers were using the device for the first time, Perlman et al. noted their inexperience could have led to suboptimal results in patient selection and procedural performance.