Adam B. Greenbaum, MD: Transcatheter Treatment of Tricuspid Regurgitation: One-Year Results of the CLASP-TR Study

Read more about CLASP-TR here.

A lightly edited transcript of Dr. Greenbaum's remarks is below.

Hello. I'm Dr. Greenbaum from Emory University, and I just presented one-year results from the CLASP-TR early feasibility study. So in brief, tricuspid regurgitation is pretty common as the population ages. There's significant morbidity and mortality associated with it, and our current therapies aren't that good. Aside from diuretics, we don't have much to offer. And we do have surgery, but the mortality associated with surgery for isolated tricuspid regurgitation is high, probably due to the patient's comorbidities. The Clasp TR study was designed to test the safety and the performance of the Pascal tricuspid repair system (Edwards Lifesciences) in patients with severe symptomatic tricuspid regurgitation. Primary endpoint was 30-day major adverse events. Again, a safety endpoint. All other efficacy endpoints were secondary. We enrolled 65 patients, and 46 remained in the study at one year of follow-up.

Successful device implantation was high, over 90%, and approximately 80% of patients were able to achieve at least a one point reduction in tricuspid regurgitation, with no major adverse events through 30 days. At the end of one year, five patients had died. None of whom were adjudicated as related to the device or the procedure. The overall MACE rate was about 17%. This was mostly bleeding periprocedure and early on, which is not a shock and not surprising in this population, as a lot of them are taking oral anticoagulants because of atrial fibrillation. And there was an 18% rehospitalization rate throughout the year. The Kaplan-Meier estimates of survival and freedom from hospitalization were 88% and 79%, respectively.

In conclusion, the CLASP-TR early feasibility study did show safety of the repair system with reasonable, encouraging survival compared to the historical expected mortality of about 30% at one year. And this was a durable result. What we saw at 30 days was maintained out to one year and was associated with significant improvements in functional class, quality of life, and six-minute walk distance. The reduction was sustained. Most of the patients were New York Heart Association Class I to II, and 86% of the patients were able to achieve a residual mitral regurgitation severity of moderate or less. So encouraging results for an early feasibility study, and a pivotal randomized trial is currently underway.