Proof of Concept: Development of a Mitral Annuloplasty Ring With Crosshatch Net.

Benjamin D Seadler, David L Joyce, James Zelten, Kevin Sweeney, Taylor Wisgerhof, Zoey Slettehaugh, Y William Yuan, Brandon J Tefft, Paul J Pearson
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引用次数: 0

Abstract

Objective: Here we report our preclinical, proof-of-concept testing to assess the ability of a novel device to correct mitral regurgitation. The Milwaukee Heart device aims to enable any cardiac surgeon to perform high-quality mitral valve repair using a standard annuloplasty ring with a crosshatch of microporous, monofilament suture.

Methods: Hemodynamic, echocardiographic, and videographic data were collected at baseline, following induction of mitral regurgitation, and after repair using porcine hearts in an ex vivo biosimulator model. A commercially available cardiac prosthesis assessment platform was then used to assess the hydrodynamic characteristics of the study device.

Results: Porcine biosimulator pressure and flow metrics exhibited successful correction of mitral regurgitation following device implantation with similar values to baseline. Hydrodynamic results yielded pressure gradients and an effective orifice area comparable to currently approved prostheses.

Conclusions: The study device effectively reduced mitral valve regurgitation and improved hemodynamics in our preclinical model with similar biophysical metrics to currently approved devices. Future in vivo trials are needed to evaluate the efficacy, biocompatibility, and freedom from the most likely adverse events, such as device thrombosis, embolic events, and hemolysis.

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概念验证:开发带十字网的二尖瓣瓣环成形术。
目的:我们在此报告临床前概念验证测试,以评估一种新型装置矫正二尖瓣反流的能力。Milwaukee Heart 设备旨在使任何心脏外科医生都能使用标准的瓣环与微孔单丝缝线交叉缝合进行高质量的二尖瓣修复。方法:在基线、诱导二尖瓣反流后以及在体外生物模拟器模型中使用猪心进行修复后,收集血流动力学、超声心动图和视频数据。然后使用市售的心脏假体评估平台评估研究设备的流体动力学特性:结果:猪生物模拟器的压力和血流指标显示,装置植入后成功矫正了二尖瓣反流,其数值与基线相似。流体动力学结果显示压力梯度和有效孔面积与目前批准的假体相当:结论:该研究装置在临床前模型中有效地减少了二尖瓣反流,改善了血液动力学,其生物物理指标与目前已获批准的装置相似。未来还需要进行体内试验,以评估其疗效、生物相容性以及是否会发生最可能的不良事件,如装置血栓形成、栓塞事件和溶血。
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来源期刊
CiteScore
2.00
自引率
6.70%
发文量
80
期刊介绍: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery is the first journal whose main mission is to disseminate information specifically about advances in technology and techniques that lead to less invasive treatment of cardiothoracic and vascular disease. It delivers cutting edge original research, reviews, essays, case reports, and editorials from the pioneers and experts in the field of minimally invasive cardiothoracic and vascular disease, including biomedical engineers. Also included are papers presented at the annual ISMICS meeting. Official Journal of the International Society for Minimally Invasive Cardiothoracic Surgery
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