Continued positive outcomes with Mitraclip post-approval
Transcatheter mitral valve repair with the MitraClip device significantly improves the severity of mitral regurgitation (MR), functional status, and quality of life of patients with MR and who were at prohibitive risk for surgery, according to the MitraClip Post-Approval Study 1 (PAS1) presented at SCAI 2018.
“This is a rigorous, real-world study that includes more data than we’ve seen before,” said lead author Dr James Hermiller of St Vincent Heart Center in Indiana, Indianapolis, US.
“The outcomes were extremely encouraging and reinforce the safety and efficacy of this treatment option in real-world practice. We think it has the potential to be a new standard of care for select patients with mitral valve regurgitation.”
The prospective, multicentre, observational study included 1,998 patients (mean age 79.5 years, 56.5 percent men) in the STS/ACC* TVT** registry who underwent MitraClip procedures. A majority of the patients had degenerative MR (85.3 percent) and 90.2 percent were indicated to have prohibitive risk at baseline, with frailty (49.7 percent) and STS Mitral Valve Repair score of ≥6 percent (46.5 percent) being the most common reasons prohibiting surgery. [SCAI 2018, abstract III-03]
One year after the procedure, a significantly greater proportion of patients had MR grade 2+ (86.8 percent; p<0.0001) compared with baseline, whereby a majority were in MR grade 3+/4+ (94.7 percent).
Echocardiographic measurements also showed significant improvements in left ventricular volume (-8.5 mL; p=0.201) and dimension (-0.20 cm; p<0.0001) from baseline.
Furthermore, functional status improved remarkably in terms of a gain of 38 metres in the 6-minute walk test distance and a 30-point increase in the KCCQ*** quality-of-life scores.
At 1 year, 83.4 percent were classified as having NYHA Class I/II compared with baseline, whereby 85.6 percent had NYHA*** Class III/IV.
Rates of complications were reported at 1.8 percent for single leaflet device attachment and 0.2 percent for device embolization.
“The results demonstrate the continued safety and effectiveness profile of the MitraClip therapy in the post-approval commercial setting … in this highly comorbid, large real-world cohort,” noted Hermiller and co-authors.
The MitraClip was approved by the US FDA in 2013 for degenerative MR, hence opening up a less invasive option for treating the condition compared with conventional surgery. In addition, more data from ongoing randomized study on MR such as the COAPT## trial are eagerly awaited, which will shed light into the role of MitraClip in functional MR, according to the researchers.