Sutureless Mitral Valve Replacement: Initial Steps Toward a Percutaneous Procedure (original) (raw)
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Transcatheter mitral valve replacement: A frontier in cardiac intervention
Cleveland Clinic Journal of Medicine
As transcatheter aortic valve replacement (TAVR) has become routine, device manufacturers and investigational cardiologists have set their sights on the mitral valve. Although transcatheter mitral valve replacement (TMVR) poses several technical challenges, they appear to be surmountable, and work is proceeding. Here we review the various devices being developed and preliminary results of trials in humans.
Transcatheter Mitral Valve Replacement: State of the Art
Cardiovascular Engineering and Technology, 2020
The emergence of transcatheter aortic valve replacement (TAVR) has segued the development of transcatheter mitral valve (MV) repair devices. Transcatheter mitral valve repair has become a well-established alternative for patients with severe primary and secondary mitral regurgitation (MR) and with a perceived surgical risk. Transcatheter mitral valve replacement (TMVR) could become a more complete form of reduction of severe MR compared to MV repair devices, albeit with significant engineering challenges and all the risks associated with a bioprosthetic heart valve. The development of TMVR devices has become prominent while companies race to become the first commercially available system. Careful consideration of design challenges should be conducted by the developmental companies to ensure successful devices. Preclinical and clinical trials have shown promising results, showcasing the feasibility of total valve replacement utilizing transcatheter procedure techniques. Further development, testing, and trials need to be conducted before TMVR can become a sensible MR treatment. This review describes design challenges and considerations along with the state of the art, involving designs in both clinical and preclinical stages.
Transcatheter mitral valve interventions: current status and future perspective
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2012
With the recent developments in the field of transcatheter aortic valve replacement for aortic stenosis there has been a similar advance in the field of transcatheter mitral valve therapy for mitral regurgitation (MR). Both the anatomy of the mitral apparatus and the spectrum of pathology of MR are more complex than for aortic valve disease, and thus the development of MR therapies has been more complicated and less rapid. The purpose of this review of recent literature is to provide a synopsis of the present technologies under development for percutaneous therapy for MR. Leaflet repair with MitraClip has accrued the largest human experience among the technologies that are under development, having been used to treat over 6,000 patients. MitraClip is currently being used in patients with functional MR and at high risk for conventional surgery. Coronary sinus, or indirect annuloplasty, has the next largest clinical experience, with several hundred patients treated in trials. Other MR...
Off-pump transapical mitral valve replacement. Discussion
European Journal of Cardio Thoracic Surgery, 2009
Objective: Percutaneous valve replacement was recently introduced, and reports of early clinical experience have already been published. To date, this technique is limited to the replacement of pulmonary and aortic valves in a strictly selected group of patients. The aim of this study was to analyse a self-expanding valved stent for minimally invasive replacement of the mitral valve in animals. Methods: A newly designed nitinol stent was specially designed for this experimental acute study. It comprised of a left ventricular tubular stent with star shaped left atrial anchoring springs and carried a trileaflet bovine pericardial valve. A polytetrafluoroethylene membrane was sutured to envelop the atrial springs and the outside of the ventricular stent. The ventricular anchoring system was the same as in our previously reported results with a similar mitral valved stent. Seven pigs underwent minimally invasive off-pump mitral valved stent implantation. This was performed through a lower ministernotomy and a standard transapical approach under transoesophageal echocardiographic (TEE) guidance was used. Results: The valved stent is fully retrievable and precise deployment and accurate adjustment of its intra-annular position is achievable to eliminate paravalvular leakage. The deployment time ranged from 127 to 255 s and the blood loss from 70 to 220 cc. One animal died of intractable ventricular fibrillation. Mitral regurgitation in all surviving animals was minimal (trace in 5/6 and mild in 1/6 during echo examination; on the contrast ventriculogram no mitral insufficiency was observed except in one documented as mild paravalvular regurgitation). These animals remained haemodynamically stable (6/ 6) and without TEE or ventriculographic changes for 1 h. Conclusion: Implantation of a tricuspid bovine pericardial valved stent in the mitral position is feasible in pigs through a transcatheter approach. This was possible through a smaller delivery system than previously reported. Additional studies are required to demonstrate long-term feasibility, durability, and heart function. #
Early Experience with New Transcatheter Mitral Valve Replacement
Journal of the American College of Cardiology, 2017
Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined. We report our early experience with TMVR using a new valve system. The valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (U.S., Australia, and Europe). 50 consecutively enrolled patients (mean age, 73±9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean STS score was 6.4±5.5%; 86% of patient were NYHA class III or IV, and the mean left ventricular ejection fraction was 43±12%. Device implant was successful in 48 patients with a median deployment time of 14 (IQR, 12, 17) minutes. The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. ...
Off-pump transapical mitral valve replacement☆
European Journal of Cardio-Thoracic Surgery, 2009
Objective: Percutaneous valve replacement was recently introduced, and reports of early clinical experience have already been published. To date, this technique is limited to the replacement of pulmonary and aortic valves in a strictly selected group of patients. The aim of this study was to analyse a self-expanding valved stent for minimally invasive replacement of the mitral valve in animals. Methods: A newly designed nitinol stent was specially designed for this experimental acute study. It comprised of a left ventricular tubular stent with star shaped left atrial anchoring springs and carried a trileaflet bovine pericardial valve. A polytetrafluoroethylene membrane was sutured to envelop the atrial springs and the outside of the ventricular stent. The ventricular anchoring system was the same as in our previously reported results with a similar mitral valved stent. Seven pigs underwent minimally invasive off-pump mitral valved stent implantation. This was performed through a lower ministernotomy and a standard transapical approach under transoesophageal echocardiographic (TEE) guidance was used. Results: The valved stent is fully retrievable and precise deployment and accurate adjustment of its intra-annular position is achievable to eliminate paravalvular leakage. The deployment time ranged from 127 to 255 s and the blood loss from 70 to 220 cc. One animal died of intractable ventricular fibrillation. Mitral regurgitation in all surviving animals was minimal (trace in 5/6 and mild in 1/6 during echo examination; on the contrast ventriculogram no mitral insufficiency was observed except in one documented as mild paravalvular regurgitation). These animals remained haemodynamically stable (6/ 6) and without TEE or ventriculographic changes for 1 h. Conclusion: Implantation of a tricuspid bovine pericardial valved stent in the mitral position is feasible in pigs through a transcatheter approach. This was possible through a smaller delivery system than previously reported. Additional studies are required to demonstrate long-term feasibility, durability, and heart function. #
European heart journal, 2015
Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.