transcatheter tricuspid valve replacement

经导管三尖瓣置换术
  • 文章类型: Journal Article
    三尖瓣反流(TR)是一种复杂的疾病,具有负面的前景,而手术治疗与死亡率增加有关。原发性TR是由于三尖瓣(TV)的结构缺陷而发生的,虽然继发性TR是一种更普遍的疾病,通常与肺动脉高压有关,心力衰竭,和心房颤动。由于增加的手术风险和延迟的患者表现,在日常临床实践中使用特定的外科手术来改善TR是有限的。其他经导管心脏瓣膜手术的发展导致了经导管电视手术的显着增加,这可以归因于某些技术进步。本综述旨在提供经导管电视程序的最新概述,可用的替代疗法,和患者选择标准。它还将突出该领域的发展现状,其特点是进展迅速,许多正在进行的临床试验。
    Tricuspid regurgitation (TR) is an intricate disorder that has a negative outlook, while surgical treatment is linked to increased mortality. Primary TR occurs due to a structural defect in the tricuspid valve (TV), while secondary TR is a more prevalent condition often associated with pulmonary hypertension, heart failure, and atrial fibrillation. The use of specific surgical procedures to improve TR is limited in everyday clinical practice due to the heightened surgical risk and delayed patient presentation. The development of other transcatheter heart valve procedures has led to a significant increase in transcatheter TV operations, which can be attributed to certain technological advancements. This review aims to provide an updated overview of transcatheter TV procedures, available alternative therapies, and standards for patient selection. It will also highlight the current state of development in this field, which is characterized by rapid progress and numerous ongoing clinical trials.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    大部分接受经导管三尖瓣介入治疗(TTVI)的患者将存在心脏可植入电子设备(CIED)。在这样的病人中,手术矫正三尖瓣返流(TR)与高发病率和高死亡率相关.经静脉引线提取(TLE)可能会改善CIED引起的TR;但是,它具有固有的风险,通常不会导致TR改善。随着多个TTVI设备正在试用以获得监管部门的批准,了解哪种治疗在aCIED患者中最合适是至关重要的.这篇综述集中在非手术治疗,包括TLE和经导管三尖瓣修复和置换选项,旨在提高同时患有CIED的TR患者的预后。
    A large proportion of patients referred for transcatheter tricuspid valve intervention (TTVI) will have the presence of a cardiac implantable electronic device (CIED). In such patients, surgical correction of tricuspid regurgitation (TR) is associated with high rates of morbidity and mortality. Transvenous lead extraction (TLE) could potentially ameliorate CIED-induced TR; however, it carries inherent risks and frequently does not result in TR improvement. As multiple TTVI devices are in trial to gain regulatory approval, understanding which therapy is most appropriate among patients with a CIED is essential. This review centers on the nonsurgical treatment, including TLE and transcatheter tricuspid valve repair and replacement options, aimed at enhancing outcomes in patients with TR who also have concurrent CIEDs.
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  • 文章类型: Journal Article
    经导管三尖瓣置换术(TTVR)最近成为治疗严重三尖瓣返流(TR)的一种新的治疗方法。然而,手术三尖瓣置换术(STVR)仍然是主要的治疗方式。关于这两种程序的比较数据有限。这项研究旨在比较接受小切口经心房LuX瓣膜TTVR的患者和接受STVR的患者之间的临床和超声心动图结果。
    本研究前瞻性收集了2019年至2022年在武汉协和医院接受TTVR(n=29)或孤立STVR(n=59)的重度TR患者。所有TTVR患者均通过小切口和经心房入路接受了LuX瓣膜。比较30天和1年随访时的临床和超声心动图结果。
    在基线时,与STVR相比,接受LuX-ValveTTVR的患者具有更高的手术风险评分和更高的右心室功能障碍比例.在术后早期,STVR组右心室功能下降幅度更大.住院时间(LOS)重症监护室LOS,总手术时间,TTVR组气管插管时间短于STVR组。在接受TTVR的患者中,术后瓣膜旁漏的发生率较高。与STVR组相比,TTVR组的起搏器植入率较低.随访期间,TTVR组的三尖瓣峰值速度和平均梯度始终低于STVR组.在30天和一年的随访中,TTVR和STVR的死亡率相似。
    经心房的微型开胸手术LuX瓣膜TTVR比STVR具有更高的瓣周漏发生率和更低的起搏器植入率,30天和1年死亡率相似。在某些方面,小切口经心房LuX瓣膜TTVR可能是特定人群可行和安全的治疗选择,或者它可能作为补充常规STVR的替代疗法。需要进一步随访以评估长期临床结果和瓣膜耐久性的差异。
    UNASSIGNED: Transcatheter tricuspid valve replacement (TTVR) has recently emerged as a novel therapeutic approach for managing severe tricuspid regurgitation (TR). However, surgical tricuspid valve replacement (STVR) continues to be the predominant treatment modality. There are limited comparative data on both procedures. This study aimed to compare clinical and echocardiographic outcomes between patients who underwent mini-thoracotomy transatrial LuX-Valve TTVR and those who underwent STVR.
    UNASSIGNED: This study prospectively collected patients with severe TR who underwent TTVR (n = 29) or isolated STVR (n = 59) at Wuhan Union Hospital from 2019 to 2022. All TTVR patients received the LuX-Valve via a mini-thoracotomy and transatrial approach. The clinical and echocardiographic outcomes were compared at 30-day and one-year follow-ups.
    UNASSIGNED: At baseline, patients with LuX-Valve TTVR had higher surgical risk scores and a greater proportion of right ventricular dysfunction compared with STVR. In the early postoperative period, the STVR group had a greater decrease in right ventricular function. Hospital length of stay (LOS), intensive care unit LOS, total procedure time, and tracheal intubation time were shorter in the TTVR than in the STVR group. The incidence of postoperative paravalvular leaks was higher among patients who underwent TTVR. Compared to the STVR group, the pacemaker implantation rate was lower in the TTVR group. During follow-up, the peak tricuspid valve velocity and mean gradient in the TTVR group were consistently lower than those in the STVR group. There was similar mortality between TTVR and STVR at 30-day and one-year follow-ups.
    UNASSIGNED: The mini-thoracotomy transatria LuX-Valve TTVR has a higher incidence of paravalvular leaks and a lower rate of pacemaker implantation than STVR, with similar 30-day and one-year mortality rates. In some respects, mini-thoracotomy transatrial LuX-Valve TTVR may be a feasible and safe treatment option for specific populations, or it could potentially serve as an alternative therapy to supplement conventional STVR. Further follow-up is required to assess differences in long-term clinical outcomes and valve durability.
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  • 文章类型: Case Reports
    相对于目前的治疗选择,经导管三尖瓣置换术(TTVR)为大量严重三尖瓣反流患者提供了改善预后的潜力。成像是该程序成功的关键组成部分。在这里,我们描述了在TTVR手术期间使用三维心内超声心动图作为标准经食道超声心动图辅助手段的策略和技术。
    Transcatheter tricuspid valve replacement (TTVR) offers the potential for improved outcomes for the significant number of patients with severe tricuspid valve regurgitation relative to current treatment options. Imaging is a critical component of the success of this procedure. Here we describe strategies and techniques for the use of 3-dimensional intracardiac echocardiography as an adjunct to standard transesophageal echocardiography during TTVR procedure.
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  • 文章类型: Journal Article
    背景:心力衰竭(HHF)住院率和死亡率降低与三尖瓣反流(TR)相关。
    目的:本研究的目的是探讨经导管三尖瓣置换术(TTVR)相对于指南指导的药物治疗(GDMT)对有症状的重度TR患者的益处。
    方法:在2020年5月至2023年4月之间,我们中心治疗了88例有症状的重度TR患者。其中,57例患者单独接受GDMT,31例患者接受了TTVR和GDMT联合治疗。我们收集并分析了基线数据,以及两组的随访信息。主要终点是全因死亡率和联合终点(包括全因死亡率和HHF)。
    结果:在中位20(IQR10-29)个月的随访中,TR严重程度显着改善,右心室功能,TTVR组各维度(均P<0.001)。它还导致了更高的生存率(75.8%vs.48.4%,P=0.019),改善了合并终点的自由度(61.5%与45.9%,P=0.007)和较少的主要不良事件。在按TRI-SCORE分层后,TTVR组中<6分的亚组与其他亚组相比,在联合终点方面表现出显着差异(所有P<0.05),而在GDMT亚组中没有观察到显著差异(P=0.680)。
    结论:在TTVR中使用LuX-Valve可有效改善TR,并降低主要不良事件的发生率。HHF和全因死亡率。TRI-SCORE可能有助于从TTVR中识别出更高获益的TR患者。临床试验注册ClinicalTrials.gov方案注册系统(NCT02917980)。
    BACKGROUND: Impaired hospitalizations for heart failure (HHF) and mortality are associated with tricuspid regurgitation (TR).
    OBJECTIVE: The objective of this study was to investigate the benefit of transcatheter tricuspid valve replacement (TTVR) over guideline-directed medical therapy (GDMT) in patients with symptomatic severe TR.
    METHODS: Between May 2020 and April 2023, 88 patients with symptomatic severe TR were treated in our center. Of these, 57 patients received GDMT alone, and 31 patients underwent combined TTVR and GDMT. We collected and analyzed baseline data, and follow-up information for both groups. The primary endpoints were all-cause mortality and the combined endpoint (including all-cause mortality and HHF).
    RESULTS: At a median follow-up of 20 (IQR 10-29) months, significant improvements were shown in TR severity, right ventricular function, and dimensions in TTVR group (all P < 0.001). It also resulted in superior survival rates (75.8% vs. 48.4%, P = 0.019), improved freedom from combined endpoint (61.5% vs. 45.9%, P = 0.007) and fewer major adverse events. After stratification by TRI-SCORE, the subgroup with < 6 points in the TTVR group exhibited a significant difference in the combined endpoint compared to the other subgroups (all P < 0.05), while no significant differences were observed in the GDMT subgroups (P = 0.680).
    CONCLUSIONS: The utilization of LuX-Valve in TTVR effectively improves TR and is associated with lower rates of major adverse events, HHF and all-cause mortality. The TRI-SCORE may help identify higher-benefit patients with TR from TTVR. Clinical trial registration ClinicalTrials.gov Protocol Registration System (NCT02917980).
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  • 文章类型: Journal Article
    经皮治疗方案的出现为处于任何外科手术高风险的老年和虚弱患者提供了新的治疗选择。我们的审查的目的是提供一个最新的分析迅速扩大的领域的经皮技术的二尖瓣,三尖瓣,和肺部手术。边缘到边缘修复是继发性二尖瓣返流(MR)的既定治疗方法,而经导管二尖瓣置换术是治疗继发性和原发性MR的潜在和扩展选择。然而,额外的改进是必要的,以提高该程序的安全性和可行性。经导管三尖瓣介入治疗是在主动脉瓣和二尖瓣经导管手术成功后构思的新兴选择。目前仍处于发展的早期阶段。这可以归因于,至少在某种程度上,先前忽略的三尖瓣反流对患者预后的影响。边缘到边缘修复的发展代表了经导管手术创新的前沿。关于三尖瓣成形术和置换术的数据很少,需要进一步研究。经导管二尖瓣,三尖瓣,肺部手术显示了未来的前景,虽然它们在临床实践中的作用尚未明确确立。
    The emergence of percutaneous treatment options provides novel therapeutic alternatives for older and feeble patients who are at high risk for any surgical procedure. The purpose of our review was to offer an up-to-date analysis of the rapidly expanding field of percutaneous technologies for mitral, tricuspid, and pulmonary procedures. Edge-to-edge repair is an established treatment for secondary mitral regurgitation (MR), while transcatheter mitral valve replacement is a potential and expanding option for managing both secondary and primary MR. However, additional advancements are necessary to enhance the safety and feasibility of this procedure. Transcatheter tricuspid intervention is an emerging option that was conceived after the success of transcatheter procedures in aortic and mitral valves, and it is currently still in the early stages of advancement. This can be attributed, at least in part, to the previously overlooked effect of tricuspid regurgitation on patient outcomes. The development of edge-to-edge repair represents the forefront of innovations in transcatheter procedures. There is a scarcity of data about tricuspid annuloplasty and replacement, and further study is necessary. Transcatheter mitral, tricuspid, and pulmonary procedures show prospects for the future, while their role in clinical practice has not been definitively established.
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  • 文章类型: Case Reports
    经导管三尖瓣置换术(TTVR)是严重三尖瓣反流(TR)患者越来越多地使用的治疗技术。目前,来自国际注册中心和随机对照试验的现有数据提供了直至手术后2年最大随访的结局数据.该病例报告提供了一名84岁女性的4年随访数据,该女性在2019年因TURRENTVR接受了TTVR。患者经历了持久的TR降低,症状改善,右心室逆重构,和显著改善肝肾功能。
    Transcatheter tricuspid valve replacement (TTVR) is an increasingly used treatment technique for patients with severe tricuspid regurgitation (TR). Currently, available data from international registries and randomized controlled trials provide outcome data until a maximum follow-up of 2 years after the procedure. This case report presents 4-year follow-up data for an 84-year-old woman who underwent TTVR for torrential TR in 2019. The patient experienced durable TR reduction, symptomatic improvement, right ventricular reverse remodeling, and substantial improvement in liver and kidney function.
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  • 文章类型: Journal Article
    背景:由于治疗选择有限,严重的三尖瓣反流在很大程度上仍未得到充分治疗。经导管三尖瓣介入治疗已成为这些患者的一种有希望的治疗方法。TRISCENDII关键试验是第一个评价经导管三尖瓣置换术(TTVR)的随机对照试验.
    目的:TRISCENDII关键试验研究了使用FDA突破性设备名称的经导管EVOQUE三尖瓣置换系统,该计划旨在通过加快开发来及时获取医疗器械,评估,和审查。
    方法:TRISCENDII试验是一项前瞻性,多中心试验,将有症状的严重三尖瓣反流患者随机分配到TTVR联合最佳药物治疗或单独最佳药物治疗。该试验新颖的2期设计评估了初始阶段的前150名患者的30天安全性和6个月有效性终点,以及第二阶段的400名患者的1年安全性和有效性终点。
    结果:TRISCENDII试验的2期试验设计为早期审查提供了机会,并导致了TTVR系统的首次商业批准。
    结论:TRISCENDII试验的设计可能会为未来的经导管三尖瓣装置试验提供信息。
    结论:TRISCENDII关键试验是第一个经导管三尖瓣置换术(TTVR)的随机对照试验。它是根据FDA的突破性设备计划设计的,旨在为治疗选择有限的患者带来一种新颖的TTVR疗法。2阶段设计允许对安全性和有效性结果进行早期审查,然后在1年的第二阶段进行完整的队列安全性和有效性终点。这种方法导致批准了第一个商业的经导管治疗三尖瓣置换术。
    Severe tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR). The TRISCEND II pivotal trial studies the transcatheter EVOQUE (Edwards Lifesciences, Irvine, California) tricuspid valve replacement system using a United States Food and Drug Administration Breakthrough Device Designation-a program intended to provide timely access to medical devices by speeding up development, assessment, and review. The TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial\'s novel 2-phase design evaluates 30-day safety and 6-month effectiveness end points for the first 150 patients in the initial phase and a 1-year safety and effectiveness end point for the full cohort of 400 patients in the second phase. The TRISCEND II trial\'s 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system. In conclusion, the design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials.
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  • 文章类型: Journal Article
    目的:患有严重三尖瓣返流(TR)的患者有显著的发病率和死亡率的风险。经导管三尖瓣介入治疗(TTVI)可以为患者提供手术以外的微创治疗方法。这篇综述评估了目前世界上用于治疗TR的最常见的一类设备,三尖瓣经导管边缘对边缘修复术(T-TEER)和经导管原位三尖瓣置换术(TTVR),这两种方法现在都在美国和欧洲获得批准。
    结果:第一个关键的随机临床试验,三倍,证明T-TEER可以安全地降低TR,并与改善的健康状况结果相关。然而,本试验的结果引发了人们对该装置是否能提供足够的TR降低以影响临床结局的疑问.原位TTVR最近受到关注,初步数据表明TR几乎完全消除。当前的审查审查了最常用的T-TEER和原位TTVR设备的技术特征和解剖局限性,讨论了这些设备的当前临床数据,并为器件选择提供了理论结构。
    OBJECTIVE: Patients with severe tricuspid regurgitation (TR) are at risk for significant morbidity and mortality. Transcatheter tricuspid valve interventions (TTVI) may offer patients less invasive treatment alternatives to surgery. This review evaluates the most common class of device currently used worldwide to treat TR, tricuspid transcatheter edge-to-edge repair (T-TEER) and orthotopic transcatheter tricuspid valve replacement (TTVR), both of which are now approved in the USA and Europe.
    RESULTS: The first pivotal randomized clinical trial, TRILUMINATE, demonstrated that T-TEER can safely reduce TR and is associated with improved health status outcomes. However, results of this trial have raised questions about whether this device can provide sufficient TR reduction to impact clinical outcomes. Orthotopic TTVR has recently gained attention with initial data suggesting near-complete TR elimination. The current review examines the technical features and anatomic limitations of the most commonly used devices for T-TEER and orthotopic TTVR, discusses the current clinical data for these devices, and offers a theoretical construct for device selection.
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