Transcatheter Mitral Valve-in-Valve Implantation With a New Transcatheter Heart Valve for Bioprosthetic Degeneration

Abstract

BackgroundTranscatheter mitral valve-in-valve (TMVIV) procedure with aortic transcatheter heart valves has recently become a less invasive alternative for patients with mitral bioprosthetic dysfunction. This study reports the initial experience of TMVIV implantation using the J-Valve System (JieCheng Medical Technology Corporation Ltd., Suzhou, China).MethodsA retrospective observational multicenter study was conducted to evaluate the short-term outcomes of TMVIV. In total, 26 consecutive patients with symptomatic bioprosthetic failure at eight hospitals underwent TMVIV using the J-Valve System between May 2019 and June 2021. Procedural results and clinical outcomes were analyzed using the Mitral Valve Academic Research Consortium criteria.ResultsThe mean age was 75.3 ± 7.1 years and 69.2% of patients were female. The mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 12.3 ± 8.3%. The technical success rate was 96.2%. Nine of the 26 patients (34.6%) were implanted with a J-Valve of a size equal to the internal diameters of the deteriorated prostheses. At the 30-day and 1-year follow-ups, all-cause mortality was 3.8 and 16.0% and the stroke rates were 0 and 12.0%, respectively. Device-related mortality was 0% and the mean mitral valve gradient was 6.4 ± 2.7 mm Hg. No patient experienced device embolization, left ventricular outflow tract obstruction, or mitral valve reintervention. Postprocedural mitral regurgitation was none or trace in all the patients. All the patients were in the New York Heart Association (NYHA) class ≤ II at the last follow-up.Conclusion:Transcatheter implantation of the J-Valve System in high-risk patients with mitral bioprosthetic dysfunction was found to be a reasonable alternative and associated with good short-term outcomes.

Transcatheter Mitral Valve-in-Valve Implantations Using Inverted J-Valve

“…In this study, we report 17 cases of TMVIV using J-valve at West China Hospital, Chengdu, China. Our cohort included patients with higher risks (mean STS-PROM of 28.58 ± 19.96%) compared to the study from Lu et al ( 18 ) (12.3 ± 8.3%) and Wei et al ( 19 ) (12.03 ± 10.5%). More patients underwent concomitant TAVR or TAVIV (23.5%) in our cohort.…”

“…Transapical implantation of the J-Valve prosthesis was performed under general anesthesia by an interdisciplinary heart team in a hybrid operating room. The technique of the TMVIV procedure was similar to that of Lu et al (18) and Wei et al (19). All patients were kept on warfarin therapy with an INR goal of 2-3 for 3-6 months.…”

“…It has been approved by the China National Medical Products Administration for both aortic valve stenosis and regurgitation after proved effective and safe in the multicentered study. Lu et al ( 18 ) and Wei et al ( 19 ) reported their experience with TMVIV using J-valve in 26 and 21 patients, respectively. In this study, we report 17 cases of TMVIV using inverted J-valves.…”

Transcatheter Mitral Valve-in-Valve Implantation with the Balloon-Expandable Myval Device

“…To date, the balloon-expandable SAPIEN 3 transcatheter heart valve is the only one approved for ViV procedures in both aortic and mitral position, and some cases using the mechanically expanded Lotus valve and the self-expandable J System for ViV TVMR have been reported with good results in terms of technical success and clinical outcomes [ 1 ]. However, no data regarding other balloon-expandable devices have been published in this context.…”

“…Up to 35% of the patients harboring a mitral bioprosthesis will need a redo surgery within the first 10 years after the prior procedure [ 1 ]. However, redo mitral valve surgery is a high-risk procedure with a mortality rate that grows with each reintervention, reaching 15% for a second surgery and 40% after a fourth redo mitral intervention [ 2 ].…”