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（由适用提供）：严重的主动脉瓣狭窄（AS）是一种严重的医疗状况，最终会导致死亡，但由于高周期性的手术风险，通常不加以治疗。结果，经导管主动脉瓣置换（TAVR）疗法已成为假体主动脉瓣递送的经皮方法。 TAVR之后的并发症与甲虫泄漏有关，尽管成像方式用于评估TAVR之前的主动脉瓣环大小，但这些方法是主观的，并且还可以增加额外的时间，成本，成本和临床程序。由于在阀部署前进行瓣膜成形术是进行瓣膜成形术的标准程序，因此可以从瓣膜成形术气球中获得环形尺寸信息，并用于选择适当的阀尺寸。气球的压力/直径关系在这里可能很有用，但是，非均匀的气球膨胀使得半固定瓣膜成形术气球的主动脉瓣环的大小难以进行。因此，我们已经开发了一种新型的尺寸瓣膜成形术电导气囊（SVCB）导管系统，该系统起作用，可作为典型的瓣膜成形术气球导管，但具有其他功能，可准确显示实时的实时功能 使用电导测量值进行主动脉环评估的气囊大小。这与其他依靠标准压力/直径关系的系统不同，可以在整个气球上获取气球大小。相反，我们的系统使用物理学的电法来获得精确的环形尺寸目的地，任何不对称在通货膨胀期间可能出现的不对称。大小的结果在简单的床边控制台显示屏上实时显示，以帮助气球膨胀期间的物理（即类似于电流显示在通货膨胀期间的压力）。我们的SVCB导管系统在板凳上和健康猪中的初步结果表现出极好的精度（直径误差为2％），重复性（直径<1％误差）和安全性（无心律失常或死亡）也是如此。但是，需要额外的工作来完善控制台和导管，并在转换为MAN（Future II阶段应用）之前进一步验证系统中的系统（本I阶段应用）。因此，在此I阶段应用中，我们提出了创建临床准备就绪的SVCB导管系统及其在猪中的体内验证。根据该技术的物理基础和出色的初步尺寸和安全性结果，SVCB导管系统有望提供高度准确且可重复的主动脉周围大小的实时数字显示，几乎不需要体格检查。该项目有能力影响多种合并症的患者，并在NHLBI和NIND（包括NHLBI和NINDS）（包括NHLBI和NIND）（包括NIH机构）中覆盖。

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