First-in-Human Case of Transfemoral CardiAQ Mitral Valve Implantation

Søndergaard, Lars; Backer, Ole De; Franzen, Olaf; Holme, Susanne; Ihlemann, Nikolaj; Vejlstrup, Niels; Hansen, Per Brinch; Quadri, Arshad

doi:10.1161/circinterventions.115.002135

Cited by 75 publications

(39 citation statements)

References 4 publications

(8 reference statements)

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“…64 Four transcatheter mitral valve systems 65–67 that have subsequently been implanted in humans (Figure 3) and are in current clinical use include the second-generation CardiAQ valve system (Edwards Lifesciences, Irvine, CA, USA), Tiara valve (Neovasc Inc., Richmond, Canada), Tendyne valve (Tendyne Inc., Roseville, MN, USA), and Twelve valve (Medtronic, Minneapolis, MN, USA).…”

Section: Future Perspectives: Transcatheter Mitral Valve Replacementmentioning

confidence: 99%

Mitral Valve Replacement—Current and Future Perspectives

Merwe

Casselman

2017

Open�J Cardiovasc Surg

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The favorable outcomes achieved with modern mitral valve repair techniques redefined the role of mitral valve replacement. Various international databases report a significant decrease in replacement procedures performed compared with repairs, and contemporary guidelines limit the application of surgical mitral valve replacement to pathology in which durable repair is unlikely to be achieved. The progressive paradigm shift toward endoscopic and robotic mitral valve surgery is also paralleled by rapid developments in transcatheter devices, which is progressively expanding from experimental approaches to becoming clinical reality. This article outlines the current role and future perspectives of contemporary surgical mitral valve replacement within the context of mitral valve repair and the dynamic evolution of exciting transcatheter alternatives.

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Section: Future Perspectives: Transcatheter Mitral Valve Replacementmentioning

confidence: 99%

Mitral Valve Replacement—Current and Future Perspectives

Merwe

Casselman

2017

Open�J Cardiovasc Surg

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“…However, a number of solutions have been proposed, with many already at the stage of clinical trial (these include the CardiAQ 51,52 and Fortis ,2,8 Edwards Lifescience; the Tendyne ,39 Tendyne Holdings Inc., Roseville MN, USA; the Tiara ,14 Neovasc, Richmond, Canada; the NaviGate , NaviGate Cardiac Structures Inc., Lake Forest, CA, USA; and the Intrepid , Medtronic, Dublin, Ireland) 31. Despite the reduced number of patients involved in the trials and the large 30 days mortality rate, justified by the compassionate ground of the implants, this early experience has confirmed the potential benefit of the treatment and the ability of transcatheter solutions to successfully replace the mitral valve function 31.…”

Section: Discussionmentioning

confidence: 99%

Design, Analysis and Testing of a Novel Mitral Valve for Transcatheter Implantation

et al. 2017

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Mitral regurgitation is a common mitral valve dysfunction which may lead to heart failure. Because of the rapid aging of the population, conventional surgical repair and replacement of the pathological valve are often unsuitable for about half of symptomatic patients, who are judged high-risk. Transcatheter valve implantation could represent an effective solution. However, currently available aortic valve devices are inapt for the mitral position. This paper presents the design, development and hydrodynamic assessment of a novel bi-leaflet mitral valve suitable for transcatheter implantation. The device consists of two leaflets and a sealing component made from bovine pericardium, supported by a self-expanding wireframe made from superelastic NiTi alloy. A parametric design procedure based on numerical simulations was implemented to identify design parameters providing acceptable stress levels and maximum coaptation area for the leaflets. The wireframe was designed to host the leaflets and was optimised numerically to minimise the stresses for crimping in an 8 mm sheath for percutaneous delivery. Prototypes were built and their hydrodynamic performances were tested on a cardiac pulse duplicator, in compliance with the ISO5840-3:2013 standard. The numerical results and hydrodynamic tests show the feasibility of the device to be adopted as a transcatheter valve implant for treating mitral regurgitation.Electronic supplementary materialThe online version of this article (doi:10.1007/s10439-017-1828-2) contains supplementary material, which is available to authorized users.

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“…The first-in-human implantation of the firstgeneration CardiAQ was done in 2012 (34). Since then, 13 cases have been reported, including 1 additional patient treated through a transfemoral approach with the second-generation valve (35,36).…”

Section: Prosthetic Valve Structural Degenerationmentioning

confidence: 99%

Transcatheter Mitral Valve Replacement

Regueiro

Granada

Dagenais

et al. 2017

Journal of the American College of Cardiology

206

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Transcatheter mitral valve repair, particularly edge-to-edge leaflet repair, is a well-established alternative for patients with severe primary mitral regurgitation (MR) considered at high or prohibitive surgical risk. More recently, transcatheter mitral valve replacement (TMVR) has emerged as a potential therapeutic option for the treatment of severe MR. TMVR may offer some advantages over transcatheter repair by providing a more complete and reproducible MR reduction. Several devices are under preclinical and clinical evaluation, and the early experience with more than 100 patients has demonstrated the feasibility of TMVR. In this review, we describe the TMVR systems currently in development and the results obtained from early clinical experiences. We also discuss the main challenges in and future perspectives on this emerging field. Future studies with a much larger number of patients are needed to provide consistent safety and efficacy data on each of the TMVR systems.

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First-in-Human Case of Transfemoral CardiAQ Mitral Valve Implantation

Cited by 75 publications

References 4 publications

Mitral Valve Replacement—Current and Future Perspectives

Mitral Valve Replacement—Current and Future Perspectives

Design, Analysis and Testing of a Novel Mitral Valve for Transcatheter Implantation

Transcatheter Mitral Valve Replacement

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