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Invasive Assessment of Right Ventricular to Pulmonary Artery Coupling Improves 1-year Mortality Prediction After Transcatheter Aortic Valve Replacement and Anticipates the Persistence of Extra-Aortic Valve Cardiac Damage 对右心室与肺动脉耦合的侵入性评估可提高经导管主动脉瓣置换术后1年死亡率的预测并预知主动脉瓣外心脏损伤的持续性
Q4 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.shj.2024.100282
Mark Lachmann MD , Amelie Hesse , Teresa Trenkwalder MD , Erion Xhepa MD, PhD , Tobias Rheude MD , Moritz von Scheidt MD , Héctor Alfonso Alvarez Covarrubias MD , Elena Rippen , Oksana Hramiak MD , Costanza Pellegrini MD , Tibor Schuster PhD , Shinsuke Yuasa MD, PhD , Heribert Schunkert MD , Adnan Kastrati MD , Christian Kupatt MD , Karl-Ludwig Laugwitz MD , Michael Joner MD

Background

The interplay between the right ventricle and the pulmonary artery, known as right ventricular to pulmonary artery (RV-PA) coupling, is crucial for assessing right ventricular systolic function against the afterload from the pulmonary circulation. Pulmonary artery pressure levels are ideally measured by right heart catheterization. Yet, echocardiography represents the most utilized method for evaluating pulmonary artery pressure levels, albeit with limitations in accuracy. This study therefore aims to evaluate the prognostic significance of right ventricular to pulmonary artery (RV-PA) coupling expressed as tricuspid annular plane systolic excursion (TAPSE) related to systolic pulmonary artery pressure (sPAP) levels measured by right heart catheterization (TAPSE/sPAPinvasive) or estimated by transthoracic echocardiography (TAPSE/sPAPechocardiography) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).

Methods

Using data from a bicentric registry, this study compares TAPSE/sPAPinvasive vs. TAPSE/sPAPechocardiography in predicting 1-year all-cause mortality after TAVR.

Results

Among 333 patients with complete echocardiography and right heart catheterization data obtained before TAVR, their mean age was 79.8 ± 6.74 years, 39.6% were female, and general 1-year survival was 89.8%. sPAPinvasive and sPAPechocardiography showed only moderate correlation (Pearson correlation coefficient R: 0.53, p value: <0.0001). TAPSE/sPAPinvasive was superior to TAPSE/sPAPechocardiography in predicting 1-year all-cause mortality after TAVR (area under the curve: 0.662 vs. 0.569, p value: 0.025). Patients with reduced TAPSE/sPAPinvasive levels (< 0.365 mm/mmHg) evidenced significantly lower 1-year survival rates than patients with preserved TAPSE/sPAPinvasive levels (81.8 vs. 93.6%, p value: 0.001; hazard ratio for 1-year mortality: 3.09 [95% confidence interval: 1.55-6.17]). Echocardiographic follow-up data revealed that patients with reduced RV-PA coupling suffer from persistent right ventricular dysfunction (TAPSE: 16.6 ± 4.05 mm vs. 21.6 ± 4.81 mm in patients with preserved RV-PA coupling) and severe tricuspid regurgitation (diagnosed in 19.7 vs. 6.58% in patients with preserved RV-PA coupling).

Conclusions

RV-PA coupling expressed as TAPSE/sPAPinvasive can refine stratification of severe aortic stenosis patients into low-risk and high-risk cohorts for mortality after TAVR. Moreover, it can help to anticipate persistent extra-aortic valve cardiac damage, which will demand further treatment.

背景右心室与肺动脉之间的相互作用,即右心室与肺动脉(RV-PA)耦合,对于评估右心室收缩功能与肺循环后负荷的关系至关重要。肺动脉压力水平最好通过右心导管检查来测量。然而,超声心动图是评估肺动脉压力水平最常用的方法,但其准确性有一定的局限性。因此,本研究旨在评估右心室与肺动脉(RV- PA)耦合的预后意义。PA)耦合的预后意义。在接受经导管主动脉瓣置换术(TAVR)的重度主动脉瓣狭窄患者中,以三尖瓣环平面收缩期偏移(TAPSE)表示的耦合与右心导管测量(TAPSE/sPAPinvasive)或经胸超声心动图估测(TAPSE/sPAPechocardiography)的肺动脉收缩压(sPAP)水平相关。方法利用双中心登记的数据,本研究比较了 TAPSE/sPAPinvasive 与 TAPSE/sPAPechocardiography 在预测 TAVR 术后 1 年全因死亡率方面的作用。结果在 TAVR 术前获得完整超声心动图和右心导管检查数据的 333 例患者中,平均年龄为 79.sPAP无创和sPAP超声心动图仅显示出中等相关性(皮尔逊相关系数R:0.53,P值:<0.0001)。在预测 TAVR 术后 1 年全因死亡率方面,TAPSE/sPAPinvasive 优于 TAPSE/sPAPechocardiography(曲线下面积:0.662 对 0.569,P 值:0.025)。TAPSE/sPAPinvasive水平降低(< 0.365 mm/mmHg)的患者的1年生存率明显低于TAPSE/sPAPinvasive水平保持不变的患者(81.8% vs. 93.6%,P值:0.001;1年死亡率的危险比:3.09 [95%置信区间:1.55-6.17])。超声心动图随访数据显示,RV-PA耦合降低的患者存在持续的右心室功能障碍(TAPSE:16.6 ± 4.05 mm,而 RV-PA 耦合保留的患者为 21.6 ± 4.81 mm)和严重的三尖瓣反流(诊断为三尖瓣反流的患者为 19.7%,而诊断为三尖瓣反流的患者为 6.58%)。结论以 TAPSE/sPAPinvasive 表示的 RV-PA 耦合可将重度主动脉瓣狭窄患者细化为 TAVR 后死亡率的低风险和高风险群组。此外,它还有助于预测需要进一步治疗的持续性主动脉瓣外心脏损伤。
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引用次数: 0
Intentional Oversizing of Valve in Transcatheter Aortic Valve Replacement: Is Bigger Better? A Large, Single-Center Experience 经导管主动脉瓣置换术中瓣膜有意过大:越大越好吗?大型单中心经验
Q4 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.shj.2023.100278
Khawaja Afzal Ammar MD , Alexandria Graeber BS , Abdur Rahman Ahmad MD , Jodi Zilinski MD , Daniel P. O’Hair MD , Renuka Jain MD , Suhail Q. Allaqaband MD , Tanvir Bajwa MD

Background

The current clinical practice standard is 10% to 20% oversizing of self-expanding valves in transcatheter aortic valve replacement. We aimed to determine whether >20% oversizing of self-expanding valves (Medtronic Evolut) would lead to better valve performance with similar or better outcomes.

Methods

From October 2011 to December 2016, we approached all transcatheter aortic valve replacement patients with a conscious attempt at large oversizing (>20%). The most common valve used, excluding those used in valve-in-valve patients, was the 29-mm Evolut R (29%). We used a retrospective chart review to compare moderate oversizing (group 1; 10% to 20%) with large oversizing (group 2; >20%).

Results

Of 556 patients, 45% were male; the overall mean Society of Thoracic Surgeons risk score was 5.8 ± 3.8. Eighty-five (15%) patients needed a pacemaker, and 21 (3.8%) developed significant paravalvular leak. Mean oversizing was 20.3% ± 6.0%, with 41.4% of patients included in group 1 and 54.5% in group 2. Incidences of complications in group 2 vs. group 1 were as follows: a) paravalvular leak (2.0 vs. 6.1%; odds ratio = 0.31, p = 0.01), b) pacemaker (15 vs. 14%), c) gastrointestinal bleed (n = 4 vs. 0; 1.3 vs. 0.0%; p = 0.03), d) annular dissection (n = 1 vs. 0; 0.3 vs. 0%; p = 0.29), e) mortality (n = 5 vs. 4; 1.6 vs. 1.7%). Incidence of paravalvular leak was higher in those who died than survivors (13 vs. 1.3%; p ≤ 0.0001).

Conclusions

These data suggest that, in current self-expanding valves, >20% oversizing delivers a significantly lower prevalence of paravalvular leak without an increase in other complications. Since paravalvular leak is associated with increased mortality, >20% oversizing may represent a superior prosthesis choice.

背景目前的临床实践标准是在经导管主动脉瓣置换术中将自扩张瓣膜过大10%至20%。我们旨在确定>20%的自扩张瓣膜(美敦力 Evolut)过大是否会带来更好的瓣膜性能,以及相似或更好的预后。方法从 2011 年 10 月到 2016 年 12 月,我们接触了所有经导管主动脉瓣置换术患者,有意识地尝试大尺寸过大(>20%)。除瓣中瓣患者外,最常用的瓣膜是 29 毫米 Evolut R(29%)。我们使用回顾性病历审查对中度过大(第 1 组;10% 至 20%)和大度过大(第 2 组;>20%)进行了比较。结果 在 556 名患者中,45% 为男性;胸外科医师协会风险评分的总体平均值为 5.8 ± 3.8。85名患者(15%)需要安装起搏器,21名患者(3.8%)出现了严重的瓣膜旁漏。平均过大比例为 20.3% ± 6.0%,其中 41.4% 的患者属于第一组,54.5% 的患者属于第二组。 第二组与第一组的并发症发生率如下:a) 腔旁漏(2.0 vs. 6.1%;几率比 = 0.31, p = 0.01),b) 起搏器(15 vs. 14%),c) 胃肠道出血(n = 4 vs. 0; 1.3 vs. 0.0%; p = 0.03),d) 瓣环剥离(n = 1 vs. 0; 0.3 vs. 0%; p = 0.29),e) 死亡率(n = 5 vs. 4; 1.6 vs. 1.7%)。结论这些数据表明,在目前的自扩张瓣膜中,>20%的过大可显著降低瓣膜旁漏的发生率,而不会增加其他并发症。由于瓣膜旁漏与死亡率增加有关,>20%过大可能是一种更好的假体选择。
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引用次数: 0
Short-Term Outcomes of ACURATE neo2 ACURATE neo2 的短期疗效
Q4 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.shj.2023.100277
Akihiro Tobe MD , Scot Garg MD, PhD , Helge Möllmann MD, PhD , Andreas Rück MD, PhD , Won-Keun Kim MD , Andrea Buono MD , Andrea Scotti MD , Azeem Latib MD , Stefan Toggweiler MD , Antonio Mangieri MD , Mika Laine MD , Christopher U. Meduri MD , Tobias Rheude MD , Ivan Wong MBBS , Chenniganahosahalli Revaiah Pruthvi MD , Tsung-Ying Tsai MD , Yoshinobu Onuma MD, PhD , Patrick W. Serruys MD, PhD

Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs. This report reviews data on short-term clinical and echocardiographic outcomes of ACURATE neo2. A PubMed search yielded 13 studies, including 5 single arm and 8 nonrandomized comparative studies with other THVs which reported in-hospital or 30-day clinical and echocardiographic outcomes. In-hospital or 30-day all-cause mortality was ≤3.3%, which is comparable to other contemporary THVs. The rates of postprocedural ≧moderate PVL ranged 0.6%-4.7%. In multicenter propensity-matched analyses, neo2 significantly reduced the rate of ≧moderate PVL compared to neo (3.5% vs. 11.3%, p < 0.01), whereas rates were comparable to Evolut Pro/Pro+ (Neo2: 2.0% vs. Pro/Pro+: 3.1%, p = 0.28) and SAPIEN 3 Ultra (Neo2: 0.6% vs. Ultra: 1.1%, p = 0.72). The rate of permanent pacemaker implantation with neo2 was consistently low (3.3%-8.6%) except in one study, and in propensity-matched analyses were significantly lower than Evolut Pro/Pro+ (6.7% vs. 16.7%, p < 0.01), and comparable to SAPIEN 3 Ultra (8.1% vs. 10.3%, p = 0.29). In conclusion, ACURATE neo2 showed better short-term performance by considerably reducing PVL compared to its predecessor, with short-term clinical and echocardiographic outcomes comparable to contemporary THVs.

ACURATE neo是一种用于治疗重度主动脉瓣狭窄的自扩张经导管心脏瓣膜(THV),其疗效不佳的主要原因是中度/重度瓣膜旁漏(PVL)发生率较高。为了克服这一局限性,新一代 ACURATE neo2 的外部密封裙增加了 60%。有关其长期性能的数据有限,但临床证据表明其短期性能有所改善,可与当代 THV 相媲美。本报告回顾了 ACURATE neo2 的短期临床和超声心动图结果数据。在 PubMed 上搜索到 13 项研究,包括 5 项单臂研究和 8 项与其他 THV 的非随机对比研究,这些研究报告了住院或 30 天的临床和超声心动图结果。院内或30天全因死亡率≤3.3%,与其他当代THV相当。术后≧中度PVL的发生率为0.6%-4.7%。在多中心倾向匹配分析中,与neo相比,neo2显著降低了≧中度PVL的发生率(3.5% vs. 11.3%,p <0.01),而与Evolut Pro/Pro+(Neo2:2.0% vs. Pro/Pro+:3.1%,p = 0.28)和SAPIEN 3 Ultra(Neo2:0.6% vs. Ultra:1.1%,p = 0.72)的发生率相当。除一项研究外,neo2的永久起搏器植入率一直较低(3.3%-8.6%),在倾向匹配分析中显著低于Evolut Pro/Pro+(6.7% vs. 16.7%,p <0.01),与SAPIEN 3 Ultra相当(8.1% vs. 10.3%,p = 0.29)。总之,与前代产品相比,ACURATE neo2 通过显著降低 PVL 显示出更好的短期性能,其短期临床和超声心动图结果与当代 THV 相当。
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引用次数: 0
“In Sickness and in Health” "无论疾病还是健康
Q4 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.shj.2024.100303
Anthony DeMaria MD
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引用次数: 0
AltaValve Atrial Fixation System for the Treatment of Severe Mitral Regurgitation and Mitral Annular Calcification 用于治疗严重二尖瓣反流和二尖瓣环钙化的 AltaValve 心房固定系统
Q4 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.shj.2024.100294
Philippe Généreux MD , Krzysztof Wróbel MD, PhD , Michael J. Rinaldi MD , Thomas Modine MD, PhD , Vinayak Bapat MD , Vlasis Ninios MD , Paul Sorajja MD

Background

Treatment options for patients with mitral regurgitation (MR) and mitral annular calcification (MAC) are limited. The limitations of current transcatheter mitral valve replacement (TMVR) technologies include high screen failure rates, increased risk of left ventricular outflow tract obstruction, and high residual regurgitation. The aim of this study was to evaluate outcomes of TMVR with the AltaValve system (4C Medical, Maple Grove, MN), a supra-annular TMVR with atrial fixation, in patients with severe MR and moderate or severe MAC.

Methods

Six patients with moderate or severe MAC who were treated with AltaValve TMVR had procedural and mid-term outcomes available.

Results

Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR. There was no intraprocedural mortality, device malposition, embolization, or thrombosis. One patient expired 3 days postprocedure due to complications related to the transapical access. All other patients were discharged from the hospital without issues. Echocardiography assessments at 30 days showed complete resolution of MR in all patients, with 1 patient with mild MR and a mean mitral valve gradient of 3.7 ± 1.4 mmHg. All patients were in New York Heart Association Class I/II at 30-day follow-up, showing marked improvement as compared with baseline.

Conclusions

In patients with severe MR and severe MAC, the AltaValve TMVR technology may represent a viable treatment option. The atrial fixation minimizes the risk of left ventricular outflow tract obstruction and potentially expands treatable patients, especially in patients with MAC.

背景二尖瓣反流(MR)和二尖瓣环钙化(MAC)患者的治疗方案有限。目前经导管二尖瓣置换(TMVR)技术的局限性包括筛查失败率高、左心室流出道梗阻风险增加以及残余反流率高。本研究旨在评估重度 MR 和中度或重度 MAC 患者使用 AltaValve 系统(4C Medical,Maple Grove,MN)进行 TMVR 的疗效,AltaValve 系统是一种具有心房固定功能的瓣上 TMVR。中位随访时间为 232 天。出院时,80%的患者无/微量 MR,20%的患者有轻度 MR。术中无死亡、装置错位、栓塞或血栓形成。一名患者在术后 3 天因与经心尖入路相关的并发症而死亡。其他患者均顺利出院。30 天后的超声心动图评估显示,所有患者的 MR 均已完全消除,只有一名患者存在轻度 MR,二尖瓣平均梯度为 3.7 ± 1.4 mmHg。结论 对于严重 MR 和严重 MAC 患者,AltaValve TMVR 技术可能是一种可行的治疗方案。心房固定最大程度地降低了左心室流出道阻塞的风险,并有可能扩大可治疗患者的范围,尤其是对于 MAC 患者。
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引用次数: 0
New Insights and Perspective on Bioprosthetic Valve Fracture From Bench Testing and Computed Tomography Analysis 从台架测试和计算机断层扫描分析中获得生物人工瓣膜断裂的新见解和新视角
Q4 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.shj.2023.100276
Go Hashimoto MD , Santiago Garcia MD , Hirotomo Sato MD, PhD , Miho Fukui MD, PhD , Muhammad Hammadah MD , Robert Steffen MD , Joao L. Cavalcante MD , Vinayak N. Bapat MD

Background

Bioprosthetic valve fracture (BVF) during valve-in-valve TAVR (transcatheter aortic valve replacement) is a procedural adjunct designed to optimize the expansion of the transcatheter heart valve and reduce patient-prosthesis mismatch by using a high-pressure balloon to intentionally fracture the surgical heart valve (SHV).

Methods

We performed bench testing on 15 bioprosthetic SHV to examine the optimal balloon size and pressure for BVF. We assessed morphological changes and expansion of SHV by computed tomography angiography. Successful BVF was defined as balloon waist disappearance on fluoroscopy and/or sudden pressure drop during balloon inflation.

Results

Nine valves met the definition of BVF, 3 of which were confirmed by disruption of the stent frame. We classified surgical valves into 3 subsets: 1) fracturable with metal stent frame (MSF), 2) fracturable with polymer stent frame (PSF) and 3) nonfracturable. In general, valves with MSF were fractured using a balloon size = true internal diameter plus 3-5 mm inflated at high pressure (16-20 ATM) whereas valves with PSF could be fractured with a balloon size = true internal diameter plus 3-5 mm and lower balloon pressure (6-14 ATM). Gains in computed tomography angiography derived inflow area after BVF were 12.3% for MSF and 3.6% for PSF SHV.

Conclusions

Gains in CT-determined valve area after BVF depend on the physical properties of the SHV, which in turn influences pressure thresholds and balloon sizing strategy for optimal BVF. Elastic recoil of PSF valves limits the gains in inflow area after BVF.

背景在瓣膜置入式 TAVR(经导管主动脉瓣置换术)中进行生物假体瓣膜折断(BVF)是一种手术辅助方法,旨在通过使用高压球囊有意折断手术心脏瓣膜(SHV)来优化经导管心脏瓣膜的扩张并减少患者与假体的不匹配。方法我们对 15 个生物假体 SHV 进行了台架试验,以研究 BVF 的最佳球囊大小和压力。我们通过计算机断层扫描血管造影评估了 SHV 的形态变化和扩张情况。结果 9 个瓣膜符合 BVF 的定义,其中 3 个通过支架框架的破坏得到证实。我们将手术瓣膜分为三个子集:1)金属支架框架(MSF)可断裂瓣膜;2)聚合物支架框架(PSF)可断裂瓣膜;3)不可断裂瓣膜。一般来说,使用球囊尺寸 = 真实内径加 3-5 毫米并在高压(16-20 ATM)下充气可使带有 MSF 的瓣膜断裂,而使用球囊尺寸 = 真实内径加 3-5 毫米并在较低球囊压力(6-14 ATM)下充气可使带有 PSF 的瓣膜断裂。结论 BVF 后 CT 确定的瓣膜面积的增加取决于 SHV 的物理特性,而 SHV 的物理特性反过来又会影响最佳 BVF 的压力阈值和球囊尺寸策略。PSF 瓣膜的弹性反冲限制了 BVF 后流入面积的增加。
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引用次数: 0
A Comparative Study of Transcatheter Aortic Valve Implantation Views for Two Different Self-Expanding Aortic Valves 两种不同自扩张主动脉瓣的经导管主动脉瓣植入视图比较研究
Q4 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.shj.2024.100281
Vilhelmas Bajoras MD , Ivan Wong MD , Xi Wang MD , Kamilė Čerlinskaitė-Bajorė MD , Gintautas Bieliauskas MD , Ole De Backer MD, PhD
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引用次数: 0
A Simple Technique for Deploying the SENTINEL Cerebral Protection System in Bovine Aortic Arch Anatomy 在牛主动脉弓解剖中部署 SENTINEL 脑保护系统的简单技术
Q4 Medicine Pub Date : 2024-03-01 DOI: 10.1016/j.shj.2023.100228
Ajoe John Kattoor MD, Christopher Manion MD, Vijay Iyer MD, PhD

The SENTINEL Cerebral Protection System is one of the most commonly used devices for embolic protection during transcatheter aortic valve replacement. However, successful deployment of the SENTINEL device is often challenging in patients with a bovine aortic arch anatomy using the standard technique and requires extensive manipulation in the aortic arch increasing the risk of stroke. We describe a novel and simple technique of 2-filter deployment of SENTINEL device in patients with bovine arch anatomy. In this technique, after the deployment of the proximal filter, the device is hyperflexed on itself facing the lateral aspect of the ascending aorta instead of facing the descending aorta, with its tip pointing toward the common origin of the left common carotid artery (LCCA) and brachiocephalic trunk. The guidewire is then advanced to the LCCA. Since the guidewire can pass either anterior or posterior to the device shaft, the device needs to be untwisted either by clockwise or counterclockwise motion, before pulling the device shaft back to engage the LCCA, after which the distal filter can be deployed. Computed tomography scans obtained for planning transcatheter aortic valve replacement should be reviewed for the presence of bovine aortic arch anatomy so that this technique can be deployed directly, thereby reducing manipulations in the aortic arch, saving time, and not requiring additional equipment.

SENTINEL 脑保护系统是经导管主动脉瓣置换术中最常用的栓塞保护装置之一。然而,对于具有牛主动脉弓解剖结构的患者,使用标准技术成功部署 SENTINEL 装置往往具有挑战性,而且需要在主动脉弓上进行大量操作,增加了中风的风险。我们介绍了一种新颖而简单的技术,即在有牛形主动脉弓解剖结构的患者中使用 2 个过滤器部署 SENTINEL 装置。在这种技术中,在部署近端过滤器后,将装置超屈在升主动脉的外侧,而不是降主动脉的外侧,其顶端指向左颈总动脉 (LCCA) 和肱动脉干的共同起源。然后将导丝推进到 LCCA。由于导丝可以从器械轴的前方或后方通过,因此需要通过顺时针或逆时针运动来松开器械,然后再将器械轴拉回以插入 LCCA,之后就可以部署远端过滤器了。在规划经导管主动脉瓣置换术时获得的计算机断层扫描图像应检查是否存在牛主动脉弓解剖结构,以便直接部署该技术,从而减少主动脉弓内的操作,节省时间,并且不需要额外的设备。
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引用次数: 0
Editorial: Real World Transcatheter Edge to Edge Repair Eligibility in HF Patients: Finding the Opportunity 社论:真实世界中高血压患者的经导管边缘修复资格:寻找机会
Q4 Medicine Pub Date : 2024-03-01 DOI: 10.1016/j.shj.2023.100274
Anita W. Asgar MD, MSc, Theofilos Panagiotidis MD
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引用次数: 0
Eligibility and Potential Benefit of Transcatheter Edge-to-Edge Repair in a Contemporary Cohort With Heart Failure: Evidence From a Large Integrated Health Care Delivery System 当代心力衰竭患者队列中经导管边缘到边缘修复术的资格和潜在益处:来自大型综合医疗服务系统的证据
Q4 Medicine Pub Date : 2024-03-01 DOI: 10.1016/j.shj.2023.100237
Andrew P. Ambrosy MD , Jingrong Yang MA , Andrew S. Tai MD , Sadia J. Dimbil MD , Elisha A. Garcia BS , Sue Hee Sung MPH , Ankeet S. Bhatt MD, MBA , Matthew D. Solomon MD, PhD , Ivy A. Ku MD, MAS , Jacob M. Mishell MD , Edward J. McNulty MD , Jonathan G. Zaroff MD , Andrew N. Rassi MD , Jeremy Kong MD , Alan S. Go MD

Background

The eligibility and potential benefit of transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy to treat moderate-severe or severe secondary mitral regurgitation (MR) has not been reported in a contemporary heart failure (HF) population.

Methods

Eligibility for TEER based on Food and Drug Administration (FDA) labeling: (1) HF symptoms, (2) moderate-severe or severe MR, (3) left ventricular ejection fraction (LVEF) 20% to 50%, (4) left ventricular end-systolic dimension 7.0 cm, and (5) receiving GDMT (blocker + angiotensin-converting enzyme inhibitor/angiotensin receptor blocker). The proportion (%) of patients eligible for TEER. The hypothetical number needed to treat to prevent or postpone adverse outcomes was estimated using relative risk reductions from published hazard ratios in the registration trial and the observed event rates.

Results

We identified 50,841 adults with HF and known LVEF. After applying FDA criteria, 2461 patients (4.8%) were considered eligible for transcatheter mitral valve replacement (FDA+), with the vast majority of patients excluded (FDA-) based on a lack of clinically significant MR (N = 47,279). FDA+ patients had higher natriuretic peptide levels and were more likely to have a prior HF hospitalization compared to FDA- patients. Although FDA+ patients had a more dilated left ventricle and lower LVEF, median (25th-75th) left ventricular end-systolic dimension (cm) was low at 4.4 (3.7-5.1) and only 30.8% had severely reduced LVEF. FDA+ patients were at higher risk of HF-related morbidity and mortality. The estimated number needed to treat to potentially prevent or postpone all-cause hospitalization was 4.4, 8.8 for HF hospitalization, and 5.3 for all-cause death at 24 months in FDA+ patients.

Conclusions

There is a low prevalence of TEER eligibility based on FDA criteria primarily due to absence of moderate-severe or severe MR. FDA+ patients are a high acuity population and may potentially derive a robust clinical benefit from TEER based on pivotal studies. Additional research is necessary to validate the scope of eligibility and comparative effectiveness of TEER in real-world populations.

背景在当代心力衰竭(HF)人群中,除指南指导的药物治疗外,经导管边缘到边缘修补术(TEER)治疗中度或重度继发性二尖瓣反流(MR)的资格和潜在益处尚未见报道。方法根据美国食品和药物管理局(FDA)的标签,符合TEER条件的患者包括:(1)有HF症状;(2)中度或重度MR;(3)左室射血分数(LVEF)为20%至50%;(4)左室收缩末期尺寸为7.0厘米;(5)正在接受GDMT(阻滞剂+血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂)治疗。符合 TEER 条件的患者比例(%)。根据注册试验中已公布的危险比和观察到的事件发生率估算出预防或推迟不良结局所需的假定治疗人数。在应用 FDA 标准后,有 2461 名患者(4.8%)被认为符合经导管二尖瓣置换术的条件(FDA+),绝大多数患者(FDA-)被排除在外,原因是缺乏有临床意义的 MR(N = 47279)。与 FDA- 患者相比,FDA+ 患者的钠尿肽水平较高,且更有可能既往接受过心房颤动住院治疗。虽然 FDA+ 患者的左心室更加扩张,LVEF 更低,但左心室收缩末期尺寸(厘米)的中位数(第 25-75 位)较低,为 4.4(3.7-5.1),只有 30.8% 的患者 LVEF 严重降低。FDA+患者的心房颤动相关发病率和死亡率风险较高。在 24 个月内,FDA+ 患者为预防或推迟全因住院所需的估计治疗人数为 4.4 人,HF 住院为 8.8 人,全因死亡为 5.3 人。FDA+ 患者是高敏锐度人群,根据关键性研究,他们可能从 TEER 中获得显著的临床获益。有必要开展更多研究,以验证 TEER 在实际人群中的资格范围和比较效果。
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Structural Heart
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