Valvuloplasty Sizing Balloon Catheter

瓣膜成形术尺寸球囊导管

• 批准号: 8904828
• 负责人: William Combs
• 金额: $ 23.7万
• 依托单位: 3DT HOLDINGS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8904828
• 关键词: Accounting; Adverse event; Affect; Animals; Aortic Valve Stenosis; Arrhythmia; Balloon Valvotomy; Beds; Blood flow; Caliber; Calibration; Catheters; Cessation of life; Clinical; Clinical Trials; Comorbidity; Coronary; Data; Devices; Dilatation - action; Dimensions; Drops; Echocardiography; Economic Inflation; Electric Conductivity; Electrodes; Environment; Europe; Extravasation; Family suidae; Foundations; Future; Goals; Healthcare Systems; Heart Valves; Heart failure; Image; Image Analysis; Implant; Implantation procedure; Institutes; Laws; Lead; Left; Left Ventricular Dysfunction; Link; Location; Lung; Manufacturer Name; Measurement; Measures; Medical; Methods; Mitral Valve; Modeling; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; Operative Surgical Procedures; Outcome; Patients; Perioperative; Phase; Physicians; Physics; Procedures; Prosthesis; Radial; Replacement Therapy; Risk; Safety; Side; Solid; System; Technology; Time; TimeLine; Tissues; Training; Translating; Translations; United States National Institutes of Health; Validation; Venous; Work; X-Ray Computed Tomography; aortic valve; aortic valve replacement; base; clinically relevant; cost; detector; digital; electrical measurement; high risk; human study; imaging modality; in vivo; man; mortality; novel; pressure; public health relevance; temporal measurement; tool; voltage

 DESCRIPTION (provided by applicant): Severe aortic stenosis (AS) is a serious medical condition that can ultimately lead to death, but is often left untreated because of high perioperative surgical risk. As a result, transcatheter aortic valve replacement (TAVR) therapy has emerged as a percutaneous approach for prosthetic aortic valve delivery for the treatment of AS. Complications following TAVR are related to paravalvular leakage, which has been linked in part to inaccurate prosthetic valve size selection compared to the true native aortic annulus size. Although imaging modalities are used to assess aortic valve annulus size prior to TAVR, these methods are subjective, can be inaccurate, and also add additional time, cost, and clinical procedures. Since it is standard procedure to perform valvuloplasty just prior to valve deployment, annular sizing information can be obtained from the valvuloplasty balloon and used to select the proper valve size. The pressure/diameter relationship of the balloon could be useful here, however, non-uniform balloon expansion makes sizing of the aortic valve annulus difficult for semi-compliant valvuloplasty balloons. Consequently, we have developed a novel sizing valvuloplasty conductance balloon (SVCB) catheter system that functions as a typical valvuloplasty balloon catheter, but with additional functionality for accurate display of real-time balloon size for aortic annulus assessment using electrical conductance measurements. This is unlike other systems that rely on standard pressure/diameter relationships to acquire balloon size across the entire balloon. Rather our system uses an electrical law of physics to obtain precise annular dimension despite any asymmetries that could arise in the balloon dimension during inflation. The sizing results are displayed in real-time on a simple bed-side console display to aid the physician during balloon expansion (i.e., similar to current displays that show pressure during inflation). The preliminary results with our SVCB catheter system on the bench and in healthy swine showed excellent accuracy (2% diameter error), as was the repeatability (<1% diameter error), and safety (no arrhythmias or death). However, additional work is needed to refine the console and catheter and to further validate the system in diseased swine (this Phase I application) before translation to man (future Phase II application). Therefore, in this Phase I application, we propose the creation of a clinically ready SVCB catheter system and its validation in vivo in diseased swine. Based on the physics foundation of the technology and the excellent preliminary sizing and safety results, the SVCB catheter system is expected to provide highly accurate and repeatable real-time digital display of aortic annulus size with virtually no physician training required. This project has the ability to impact patients with multiple comorbidities and reach across various NIH Institutes and Centers including the NHLBI and NINDS.

 描述（由申请人提供）：重度主动脉瓣狭窄（AS）是一种严重的疾病，最终可能导致死亡，但由于围手术期手术风险高，通常不予治疗。因此，经导管主动脉瓣置换术（TAVR）治疗已成为治疗AS的人工主动脉瓣输送的经皮方法。TAVR后的并发症与瓣周漏相关，这在一定程度上与人工瓣膜尺寸选择不准确（与真实自体主动脉瓣环尺寸相比）有关。尽管在TAVR之前使用成像模式评估主动脉瓣环尺寸，但这些方法具有主观性，可能不准确，并且还增加了额外的时间、成本和临床手术。由于在瓣膜展开前进行瓣膜成形术是标准手术，因此可以从瓣膜成形术球囊获得瓣环尺寸信息，并用于选择适当的瓣膜尺寸。球囊的压力/直径关系在此可能有用，但是，不均匀的球囊扩张使得半顺应性瓣膜成形术球囊难以测量主动脉瓣环的尺寸。因此，我们开发了一种新型的瓣膜成形术传导球囊（SVCB）导管系统，其功能与典型的瓣膜成形术球囊导管相同，但具有准确显示实时血流的附加功能。 使用电导测量进行主动脉瓣环评估的球囊尺寸。这与依赖于标准压力/直径关系来获取整个球囊上的球囊尺寸的其他系统不同。相反，我们的系统使用物理学的电学定律来获得精确的环形尺寸，尽管在充气期间气球尺寸中可能出现任何不对称。尺寸测量结果实时显示在简单的床边控制台显示器上，以在球囊扩张期间帮助医生（即，类似于在充气期间显示压力的当前显示器）。我们的SVCB导管系统在实验室和健康猪中的初步结果显示了出色的准确性（2%直径误差），以及可重复性（<1%直径误差）和安全性（无心律失常或死亡）。然而，需要进行额外的工作来完善控制台和导管，并在转移到人体（未来的II期应用）之前在患病猪中进一步验证系统（本I期应用）。因此，在本I期申请中，我们提议创建临床就绪SVCB导管系统，并在患病猪体内进行确认。基于该技术的物理基础以及出色的初步尺寸测量和安全性结果，SVCB导管系统预计可提供高精度和可重复的主动脉瓣环尺寸实时数字显示，几乎不需要医生培训。该项目能够影响患有多种合并症的患者，并覆盖包括NHLBI和NINDS在内的各个NIH研究所和中心。

项目成果

Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter.

二合一主动脉瓣尺寸确定和瓣膜成形术电导球囊导管。

• DOI: 10.1002/ccd.25774
• 发表时间: 2015
• 期刊: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
• 作者: Svendsen,MarkC;Sinha,AnjanK;Berwick,ZacharyC;Combs,William;Teague,ShawnD;Lefevre,Thierry;Babaliaros,Vasilis;Kassab,Ghassan
• 通讯作者: Kassab,Ghassan