Novel transcatheter mitral valve repair systems improve regurgitation, functional class
At 1 year, leaflet transcatheter mitral valve repair demonstrated low rate of complications, high survival and sustained mitral regurgitation reduction, according to results of the CLASP study presented at the virtual PCR e-course.
Also presented at the virtual meeting, researchers reported on the safety and efficacy of the first-in-human trials of transseptal transcatheter mitral valve replacement for mitral regurgitation among high-risk patients.
Healio previously reported on the 6-month findings of the CLASP study, presented at the Heart Failure Society of America Annual Scientific Meeting.
Leaflet transcatheter mitral valve repair at 1 year
For the CLASP trial, researchers assessed the 1-year outcomes of patients with functional or degenerative mitral regurgitation (n = 109; mean age, 76 years; 57% NYHA class III or IV) and treated with leaflet transcatheter mitral valve repair (Pascal, Edwards Lifesciences). All participants had mitral regurgitation of three or more.
Researchers found that at 1 year, survival was 92% (P < .001) and 88% of the cohort was free from HF hospitalization (P < .001).
Moreover, mitral regurgitation of one or less was achieved among 82% of patients and two or less across the entire cohort (P < .001). At 1 year, 88% of participants achieved NYHA class I or II and experienced improvement in the Kansas City Cardiomyopathy Questionnaire score by 14 points (P < .001).
“At 1 year, the Pascal transcatheter repair system resulted in high survival and low complication rates with robust and sustained mitral regurgitation reduction, accompanied by significant improvements in functional status and quality of life,” John Webb, MD, medical director of the catheterization lab at St. Paul’s Hospital in Vancouver, Canada, and colleagues wrote in the study that was simultaneously published in JACC: Cardiovascular Interventions. “Analysis by etiology showed similar favorable results in patients with functional mitral regurgitation or degenerative mitral regurgitation. The CLASP IID/IIF randomized clinical trial is underway.”
Future research
“As already the case for transcatheter aortic valve implantation, there is certainly enough space for multiple devices with different characteristics in the toolbox of transcatheter mitral valve repair,” Stephan Windecker, MD, director of the department of cardiology at the Bern University Hospital in Switzerland, and colleagues wrote in a related editorial. “In the near future, head-to-head comparisons between these systems will be of interest. The CLASP DII/F study comparing the Pascal and the MitraClip system is already underway and further studies with the latest iteration of the MitraClip (Gen 4) may provide insightful information.”
Transseptal transcatheter mitral valve replacement
For another study, also presented by Webb at PCR e-course, investigators sought to examine the first-in-human use of the novel transseptal transcatheter mitral valve replacement system (Evoque, Edwards Lifesciences) for mitral regurgitation.
Fourteen patients with moderate to severe mitral regurgitation who were of high surgical risk (median age, 84 years; median Society of Thoracic Surgery score, 4.6%) were recruited for this trial. The primary outcome was technical success defined by Mitral Valve Academic Research Consortium criteria, according to the study.
“The Evoque device has a unique anchoring system which utilizes the annulus, leaflets and chords while respecting the native valve anatomy,” Webb and colleagues wrote in a simultaneous publication in JACC: Cardiovascular Interventions. “The delivery system offers extensive maneuverability and stability resulting in a controlled deployment without hemodynamic compromise. These properties would make the system potentially applicable for treatment of tricuspid valve disease as recently reported.”
Overall, technical success was achieved in 92.9% of the population, with one patient converted to surgery.
Researchers found that at 30 days there was one non-CV-related mortality, two strokes and no MIs or rehospitalizations. According to the study, two patients underwent paravalvular leak closure and one underwent alcohol septal ablation for a left ventricular outflow tract obstruction.
“These results are comparable to early experiences with other transcatheter mitral valve replacement systems; however, given the small numbers within this study, direct comparison cannot be drawn,” the researchers wrote. “Furthermore, there is limited data from a transseptal approach which, although less invasive than a transapical approach, provides different technical challenges.”
Moreover, at 30 days, mitral regurgitation was mild or better among all participants, with no mitral regurgitation observed among 83.3%.
In other findings, functional class was improved to NYHA class II or better among nine participants (81.8%).
“Transcatheter mitral valve replacement is a welcome addition to the range of options available in the contemporary management of mitral valve disease,” the researchers wrote. “This transseptal approach to transcatheter mitral valve replacement potentially offers advantages over a transapical approach. Continued clinical studies will continue to clarify its role within the armory of mitral interventions.”
References:
- Webb JG, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.06.040.
- Webb JG, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.06.019.
- Windecker S, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.06.021.
Collapse
Webb JG, et al. Mitral interventions – part 1. Presented at: PCR e-course; June 25-27, 2020 (virtual meeting).
Read more about