tricuspid valve

三尖瓣
  • 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: Letter
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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
    天然山羊心脏瓣膜的大体形态学检查揭示了山羊心脏解剖结构的独特结构特征。确定了四个主要孔口,每个人都受到保护,阀状结构。房室孔以三尖瓣和二尖瓣为特征,而主动脉和肺动脉由半月瓣保护。在房室腔内,观察到明显的特征,包括三尖瓣的三个小叶和二尖瓣的前后小叶。超声检查可深入了解瓣膜厚度和腱索长度。形态计量学研究比较了单个天然瓣膜内的小叶/瓣尖,展示尺寸的显著变化。天然瓣膜和脱细胞瓣膜之间的比较分析强调了脱细胞对小叶厚度和腱索长度的影响。与天然瓣膜相比,脱细胞瓣膜的尺寸减小,表明成功去除细胞成分。虽然去细胞化后的某些尺寸保持不变,小叶厚度和腱索长度显着减少。值得注意的是,半月瓣尖对去细胞化表现出不同的反应,在主动脉瓣中观察到的尖端长度显着减少,而肺动脉瓣表现出更微妙的变化。这些发现强调了了解去细胞化后心脏瓣膜结构改变的重要性。为组织工程应用和再生医学提供有价值的见解。
    The gross morphological examination of native caprine heart valves revealed distinctive structural characteristics of the caprine\'s cardiac anatomy. Four primary orifices were identified, each protected by thin, valve-like structures. Atrioventricular orifices featured tricuspid and bicuspid valves, while the aorta and pulmonary arteries were guarded by semilunar valves. Within the atrioventricular apparatus, distinct features were observed including the tricuspid valve\'s three leaflets and the bicuspid valve\'s anterior and posterior leaflets. Ultrasonography provided insights into valve thickness and chordae tendineae lengths. Morphometric studies compared leaflets/cusps within individual native valves, showcasing significant variations in dimensions. Comparative analysis between native and decellularized valves highlighted the effects of decellularization on leaflet thickness and chordae tendineae lengths. Decellularized valves exhibited reduced dimensions compared to native valves, indicating successful removal of cellular components. While some dimensions remained unchanged post-decellularization, significant reductions were observed in leaflet thicknesses and chordae tendineae lengths. Notably, semilunar valve cusps displayed varying responses to decellularization, with significant reductions in cusp lengths observed in the aortic valve, while the pulmonary valve exhibited more subtle changes. These findings underscore the importance of understanding structural alterations in heart valves post-decellularization, providing valuable insights for tissue engineering applications and regenerative medicine.
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  • 文章类型: Journal Article
    背景:已知严重的三尖瓣反流(TR)与生活质量差和不治疗时死亡风险增加有关。
    目的:报告使用TriClip系统通过三尖瓣导管边缘到边缘修复(TEER)治疗的受试者的1年临床结果,真实世界的设置。
    方法:正确的批准后研究是一项前瞻性研究,单臂,开放标签,多中心,在欧洲26个地点进行的上市后注册,包括中心事件裁定和超声心动图核心实验室评估。
    结果:登记的受试者为老年人(79±7岁),有明显的合并症。88%的受试者具有基线巨大或剧烈的TR,80%的受试者为NYHAIII/IV级。在1年时,TR降至81%的中度或更低。NYHA等级显著提高(21%至75%I/II,P<0.0001)和KCCQ评分(改善19±26分,P<0.0001)在1年时观察到。在30天达到中等或较低TR的受试者中,一年死亡率明显较低;然而,在达到中度的受试者中,死亡率没有差异,温和,或者在30天追踪TR.除了在30天减少TR外,基线血清肌酐和基线RVTAPSE与1年死亡率独立相关(OR:2.169,95%CI:[1.494,3.147],P<0.0001;OR:0.636,95%CI:[0.415,0.974],P=0.0375)。死亡率与基线TR等级无关,也没有中心体积。
    结论:使用TriClip系统的三尖瓣TEER在1年内对于患有严重TR和晚期疾病的受试者是安全有效的,现实世界的人口。
    BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated.
    OBJECTIVE: We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting.
    METHODS: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment.
    RESULTS: Enrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, P < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, P <0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375). Mortality was not associated with baseline TR grade or with center volume.
    CONCLUSIONS: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; NCT04483089).
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  • 文章类型: Journal Article
    目的:本研究的目的是评估心脏孤立性三尖瓣直视手术(TVSx)和中长期随访后的死亡率和发病率结果。
    方法:回顾性队列研究。
    方法:2002年1月1日至2018年6月30日,新南威尔士州公立和私立医院入院。
    方法:在研究期间共有537例患者接受了开放隔离的TVSx。
    方法:主要结局是从死亡登记追踪到2018年12月31日的全因死亡率。次要发病率结果,包括充血性心力衰竭(CCF),新发心房颤动(AF),感染性心内膜炎(IE),肺栓塞(PE)和插入永久性起搏器(PPM)或植入式心脏复律除颤器(ICD),从入院患者数据收集数据库进行跟踪。使用Cox回归方法确定独立的死亡率关联。
    结果:共有537例患者接受了开放隔离TVSx(46%为男性):中位年龄(IQR)为63.5岁(43.9-73.8岁),中位住院时间为16天(10-31天)。主要心血管合并症为AF(54%)和CCF(42%);风湿性三尖瓣占67%。住院和总死亡率分别为7.4%和39.3%,分别(平均随访:4.8年)。特定原因的死亡在心血管和非心血管原因之间平均分配。死亡率的预测因素包括CCF病史(HR=1.78,95%CI1.33至2.38,p<0.001)和慢性肺病(HR=2.66,95%CI1.63至4.33,p<0.001)。住院PPM率为10.0%。180天,53例(9.9%)患者因CCF入院,25(10.1%)有新的AF,7(1.5%)有新的IE,<1%有PE,放电后PPM或ICD插入。
    结论:开放隔离TVSx具有显著的死亡风险,失代偿性CCF和新发AF是手术后最常见的疾病。本报告形成了比较新的经皮三尖瓣介入治疗结果的基准。
    OBJECTIVE: The aim of the study was to evaluate mortality and morbidity outcomes following open-heart isolated tricuspid valve surgery (TVSx) with medium to long-term follow-up.
    METHODS: Retrospective cohort study.
    METHODS: New South Wales public and private hospital admissions between 1 January 2002 and 30 June 2018.
    METHODS: A total of 537 patients underwent open isolated TVSx during the study period.
    METHODS: Primary outcome was all-cause mortality tracked from the death registry to 31 December 2018. Secondary morbidity outcomes, including admission for congestive cardiac failure (CCF), new atrial fibrillation (AF), infective endocarditis (IE), pulmonary embolism (PE) and insertion of a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD), were tracked from the Admitted Patient Data Collection database. Independent mortality associations were determined using the Cox regression method.
    RESULTS: A total of 537 patients underwent open isolated TVSx (46% male): median age (IQR) was 63.5 years (43.9-73.8 years) with median length of stay of 16 days (10-31 days). Main cardiovascular comorbidities were AF (54%) and CCF (42%); 67% had rheumatic tricuspid valve. In-hospital and total mortality were 7.4% and 39.3%, respectively (mean follow-up: 4.8 years). Cause-specific deaths were evenly split between cardiovascular and non-cardiovascular causes. Predictors of mortality included a history of CCF (HR=1.78, 95% CI 1.33 to 2.38, p<0.001) and chronic pulmonary disease (HR=2.66, 95% CI 1.63 to 4.33, p<0.001). In-hospital PPM rate was 10.0%. At 180 days, 53 (9.9%) patients were admitted for CCF, 25 (10.1%) had new AF, 7 (1.5%) had new IE and <1% had PE, post-discharge PPM or ICD insertion.
    CONCLUSIONS: Open isolated TVSx carries significant mortality risk, with decompensated CCF and new AF the most common morbidities encountered after surgery. This report forms a benchmark to compare outcomes with newer percutaneous tricuspid interventions.
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  • 文章类型: Journal Article
    目的:分析自由角M型(FAM)TAPSEZ评分对Ebstein异常(EA)胎儿逆行动脉导管血流(RDAF)的影响。
    方法:纳入30例EA和60例正常胎儿的回顾性队列研究。EA组分为两组:有RDAF(EA-RDAF组)和无RDAF(EA-NRDAF组)。FAM用于测量EA和正常胎儿的TAPSE,并计算Z分数。FAM-TAPSEZ评分的差异,孕周(GW),产妇年龄(MA),比较3组二尖瓣-三尖瓣距离(MTD)。FAM-TAPSEZ得分之间的相关性和二元逻辑回归,GW,MA,MTD,和RDAF进行了分析。
    结果:EA-RDAF组的FAM-TAPSEZ评分明显低于其他组(p<0.05)。FAM-TAPSEZ-score,GW,MA与RDAF呈负相关(p<0.05),但在TR之间没有发现相关性,MDT,和RDAF(p>0.05)。多因素logistic回归分析显示,FAM-TAPSEZ评分是RDAF的独立影响因素(OR=0.102,p<0.05)。
    结论:RV功能障碍是导致EA胎儿RDAF的独立因素,为进一步研究通过宫内治疗延缓和预防RDAF改善RV功能提供了可行的理论依据,避免死亡周期,提高活产率。
    OBJECTIVE: To analyze the influence of RV dysfunction evaluated by Free-angle M-mode (FAM) TAPSE Z-score on retrograde ductus arteriosus flow (RDAF) in fetuses with Ebstein anomaly (EA).
    METHODS: A retrospective cohort study of 30 EA and 60 normal fetuses were enrolled. The EA group was divided into two groups: with RDAF (EA-RDAF group) and without RDAF (EA-NRDAF group). FAM was used to measure TAPSE of EA and normal fetuses, and Z-scores were calculated. The differences of FAM-TAPSE Z-score, gestational week (GW), maternal age (MA), and mitral valve-tricuspid valve distance (MTD) between three groups were compared. The correlation and binary logistic regression between FAM-TAPSE Z-score, GW, MA, MTD, and RDAF were analyzed.
    RESULTS: FAM-TAPSE Z-score was significantly lower in EA-RDAF group compared to other groups (p < 0.05). FAM-TAPSE Z-score, GW, and MA were negatively correlated with RDAF (p < 0.05), but no correlation was found between TR, MDT, and RDAF (p > 0.05). Multivariate logistic regression showed that FAM-TAPSE Z-score was an independent influencing factor for RDAF (OR = 0.102, p < 0.05).
    CONCLUSIONS: RV dysfunction is an independent factor leading to RDAF in EA fetus, which provides a feasible theoretical basis for further study on improvement of RV function through intrauterine treatment to delay and prevent the RDAF, to avoid death cycle and improve live-birth rate.
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  • 文章类型: Journal Article
    在没有血管阻塞的情况下,中心静脉压(CVP)是颅腔和尾腔静脉的静水压力,提供有关心脏功能和血管内容量状态的有价值的信息。它也是评估感染性休克患者的容量复苏和监测右心疾病患者的组成部分,心包疾病,或体积耗尽。通过侵入性中心静脉导管插入术在狗中计算中心静脉压,这在危重患者中被认为是高风险和不切实际的。本研究旨在探讨在受控低血容量条件下,使用超声心动图三尖瓣E/E'作为非侵入性方法评估麻醉健康犬CVP的可行性。经过全面的健康评估后,将10只雄性混种犬纳入研究。对于低血容量诱导,进行了抽血,和三尖瓣的超声心动图因素,包括峰值E和E'速度,在CVP减少期间测量。采用重复测量方差分析和Bonferroni事后测试来比较测量的超声心动图指数与导管插入和间歇测量方法得出的CVP值之间的平均差异。采用Spearmanρ相关系数评价超声心动图指标与CVP的相关性。E峰值速度与静脉血压相位呈显著负相关(r=-0.44,P=.001),表明E峰值速度随着CVP的逐渐降低而降低。然而,三尖瓣E'峰值速度和E/E'与CVP无关,这表明这些参数对于狗的CVP估计是不可靠的。
    In the absence of vascular obstruction, central venous pressure (CVP) is a hydrostatic pressure in the cranial and caudal vena cava, providing valuable information about cardiac function and intravascular volume status. It is also a component in evaluating volume resuscitation in patients with septic shock and monitoring patients with right heart disease, pericardial disease, or volume depletion. Central venous pressure is calculated in dogs by invasive central venous catheterization, which is considered high-risk and impractical in critically ill patients. This study aimed to investigate the feasibility of using echocardiographic tricuspid E/E\' as a noninvasive method to estimate CVP in anesthetized healthy dogs under controlled hypovolemic conditions. Ten male mixed-breed dogs were included in the study after a thorough health assessment. For hypovolemia induction, blood withdrawal was performed, and echocardiographic factors of the tricuspid valve, including peak E and E\' velocities, were measured during CVP reduction. Repeated measures analysis of variance and Bonferroni post hoc tests were employed to compare the average difference between measured echocardiographic indices and CVP values derived from catheterization and intermittent measurement methods. Spearman\'s ρ correlation coefficient was used to evaluate the correlation between echocardiographic indices and CVP. E peak velocity had a significant negative correlation with venous blood pressure phases (r = -0.44, P = .001), indicating a decrease in peak E velocity with progressive CVP reduction. However, tricuspid valve E\' peak velocity and E/E\' did not correlate with CVP, suggesting that these parameters are not reliable for CVP estimation in dogs.
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  • 文章类型: Journal Article
    三尖瓣疾病显著影响160万美国人。三尖瓣疾病的金标准治疗是植入瓣膜成形术装置。这些环状装置有各种形状和尺寸。形状和尺寸的选择通常是由手术直觉而不是科学原理做出的。
    要了解形状和尺寸对阀门力学的影响,并为其选择提供合理的依据,我们使用特定主题的有限元模型进行了虚拟案例研究。也就是说,我们在虚拟患者中植入了6种不同尺寸的4种不同的瓣环成形术装置。每次虚拟手术后,我们计算了接合面积,小叶收缩末期角度,小叶应力,和弦力。
    我们发现轮廓装置在使收缩末期角度归一化时更好,而一个扁平的装置,爱德华兹经典,最大化接合面积,最小化小叶应力和弦力。我们进一步发现,减小设备尺寸会导致接合面积增加,但也会对收缩末期角度产生负面影响。压力,和弦力。
    根据我们对接合面积的分析,传单动议,小叶应力,和弦力,我们发现装置的形状和尺寸对阀门力学有重大影响。因此,我们的研究还证明了模拟工具和设备测试在虚拟患者中的价值。“将我们的研究扩展到更多的瓣膜,在未来,允许普遍的建议。
    UNASSIGNED: Tricuspid valve disease significantly affects 1.6 million Americans. The gold standard treatment for tricuspid disease is the implantation of annuloplasty devices. These ring-like devices come in various shapes and sizes. Choices for both shape and size are most often made by surgical intuition rather than scientific rationale.
    UNASSIGNED: To understand the impact of shape and size on valve mechanics and to provide a rational basis for their selection, we used a subject-specific finite element model to conduct a virtual case study. That is, we implanted 4 different annuloplasty devices of 6 different sizes in our virtual patient. After each virtual surgery, we computed the coaptation area, leaflet end-systolic angles, leaflet stress, and chordal forces.
    UNASSIGNED: We found that contoured devices are better at normalizing end-systolic angles, whereas the one flat device, the Edwards Classic, maximized the coaptation area and minimized leaflet stress and chordal forces. We further found that reducing device size led to increased coaptation area but also negatively impacted end-systolic angles, stress, and chordal forces.
    UNASSIGNED: Based on our analyses of the coaptation area, leaflet motion, leaflet stress, and chordal forces, we found that device shape and size have a significant impact on valve mechanics. Thereby, our study also demonstrates the value of simulation tools and device tests in \"virtual patients.\" Expanding our study to many more valves may, in the future, allow for universal recommendations.
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