Benefits of transcatheter repair of mitral regurgitation maintained at 2 years – CLASP study

Reuters Health - 20/05/2021 -  Two-year results from the CLASP study of transcatheter repair of mitral regurgitation (MR) show that benefits are sustained and, in a few patients with functional disease, the MR can virtually disappear between the first and second year after the procedure.

The findings are presented in the journal JACC: Cardiovascular Interventions and were unveiled at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

The study was funded by Edwards Lifesciences, which makes the PASCAL transcatheter valve repair system used in the single-arm test of 124 patients.

At the two-year mark, the overall rate of survival - or, as characterized in the report, "freedom from mortality" - was 80%.

But that rate varied by MR type; it was 94% with degenerative MR and 72% with functional MR.

A similar trend was seen in the annualized rate of freedom from heart failure rehospitalization. Those rates were for 97% of degenerative MR patients and 76% of patients who had functional MR.

Favorable remodeling occurred most often in patients with functional MR. Thirty days after surgery and at the one-year mark, 15% and 13%, respectively, had only a trace of MR or no detectable MR. But after two years, that proportion had jumped to 37%.

A similar trend was not seen in degenerative MR, where the odds of having only a trace of MR or no MR went from 16% at 30 days to 19% at one year, and down to 12% at two years.

At the two-year mark, 84% of patients with functional MR had mild to no disease. In volunteers with degenerative MR, the rate was 71%.

"Patients experienced sustained improved functional status, exercise capacity and quality of life" in patients with either functional or degenerative MR, said the team, led by Dr. Molly Szerlip of Baylor Scott & White The Heart Hospital Plano, in Texas.

"The results of the CLASP study are remarkable and indicate an additional differentiated tool ready for clinical routine," said Drs. Georg Goliasch and Philipp Bartko of the Medical University of Vienna in an accompanying commentary. "Presumably, these results have been achieved despite limited operator experience, indicating potential improvements of already excellent technical results with a learning curve usually observed with complex procedures."

The CLASP study had no control group. The CLASP IID and IIF studies comparing Edwards' PASCAL device and Abbott's MitraClip are ongoing.

SOURCES: https://bit.ly/2S95tJC and https://bit.ly/3f2ZP4Q JACC: Cardiovascular Interventions, online May 18, 2021

By Gene Emery



Posted on 20 May 20211 June 2021