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Clinical Value of Single-Projection Angiography-Derived FFR in Noninfarct-Related Artery. 非梗死相关动脉单次投影血管造影得出的 FFR 临床价值
IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-05-01 Epub Date: 2024-05-21 DOI: 10.1161/CIRCINTERVENTIONS.123.013844
Woochan Kwon, Ki Hong Choi, Seung Hun Lee, David Hong, Doosup Shin, Hyun Kuk Kim, Keun Ho Park, Eun Ho Choo, Chan Joon Kim, Min Chul Kim, Young Joon Hong, Sung Gyun Ahn, Joon-Hyung Doh, Sang Yeub Lee, Sang Don Park, Hyun-Jong Lee, Min Gyu Kang, Jin-Sin Koh, Yun-Kyeong Cho, Chang-Wook Nam, Hyun Sung Joh, Taek Kyu Park, Jeong Hoon Yang, Young Bin Song, Seung-Hyuk Choi, Myung Ho Jeong, Hyeon-Cheol Gwon, Joo-Yong Hahn, Joo Myung Lee

Background: The Murray law-based quantitative flow ratio (μFR) is an emerging technique that requires only 1 projection of coronary angiography with similar accuracy to quantitative flow ratio (QFR). However, it has not been validated for the evaluation of noninfarct-related artery (non-IRA) in acute myocardial infarction (AMI) settings. Therefore, our study aimed to evaluate the diagnostic accuracy of μFR and the safety of deferring non-IRA lesions with μFR >0.80 in the setting of AMI.

Methods: μFR and QFR were analyzed for non-IRA lesions of patients with AMI enrolled in the FRAME-AMI trial (Fractional Flow Reserve Versus Angiography-Guided Strategy for Management of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction), consisting of fractional flow reserve (FFR)-guided percutaneous coronary intervention and angiography-guided percutaneous coronary intervention groups. The diagnostic accuracy of μFR was compared with QFR and FFR. Patients were classified by the non-IRA μFR value of 0.80 as a cutoff value. The primary outcome was a vessel-oriented composite outcome, a composite of cardiac death, non-IRA-related myocardial infarction, and non-IRA-related repeat revascularization.

Results: μFR and QFR analyses were feasible in 443 patients (552 lesions). μFR showed acceptable correlation with FFR (R=0.777; P<0.001), comparable C-index with QFR to predict FFR ≤0.80 (μFR versus QFR: 0.926 versus 0.961, P=0.070), and shorter total analysis time (mean, 32.7 versus 186.9 s; P<0.001). Non-IRA with μFR >0.80 and deferred percutaneous coronary intervention had a significantly lower risk of vessel-oriented composite outcome than non-IRA with performed percutaneous coronary intervention (3.4% versus 10.5%; hazard ratio, 0.37 [95% CI, 0.14-0.99]; P=0.048).

Conclusions: In patients with multivessel AMI, μFR of non-IRA showed acceptable diagnostic accuracy comparable to that of QFR to predict FFR ≤0.80. Deferred non-IRA with μFR >0.80 showed a lower risk of vessel-oriented composite outcome than revascularized non-IRA.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02715518.

背景:基于默里定律的定量血流比(μFR)是一种新兴技术,只需冠状动脉造影的一次投影,准确性与定量血流比(QFR)相似。然而,在评估急性心肌梗死(AMI)中的非梗死相关动脉(non-IRA)时,该技术尚未得到验证。因此,我们的研究旨在评估μFR的诊断准确性,以及在AMI情况下推迟μFR>0.80的非IRA病变的安全性。方法:对参加 FRAME-AMI 试验(急性心肌梗死患者非梗死相关动脉狭窄管理的分数血流储备与血管造影引导策略)的 AMI 患者的非 IRA 病变的 μFR 和 QFR 进行分析,该试验包括分数血流储备(FFR)引导的经皮冠状动脉介入治疗组和血管造影引导的经皮冠状动脉介入治疗组。μFR的诊断准确性与QFR和FFR进行了比较。以非 IRA μFR 值 0.80 为临界值对患者进行分类。主要结果是以血管为导向的综合结果,即心源性死亡、非 IRA 相关心肌梗死和非 IRA 相关重复血管再通的综合结果。结果:μFR 和 QFR 分析适用于 443 例患者(552 个病变)。070),总分析时间更短(平均为 32.7 秒对 186.9 秒;P0.80),与进行经皮冠状动脉介入治疗的非 IRA 相比,延迟经皮冠状动脉介入治疗的血管导向复合结局风险显著更低(3.4% 对 10.5%;危险比为 0.37 [95% CI, 0.14-0.99]; P=0.048):在多血管急性心肌梗死患者中,非IRA的μFR在预测FFR≤0.80方面显示出与QFR相当的可接受的诊断准确性。与血管再通的非IRA相比,μFR>0.80的延迟非IRA显示出较低的血管导向复合结局风险:URL:https://www.clinicaltrials.gov;唯一标识符:NCT02715518。
{"title":"Clinical Value of Single-Projection Angiography-Derived FFR in Noninfarct-Related Artery.","authors":"Woochan Kwon, Ki Hong Choi, Seung Hun Lee, David Hong, Doosup Shin, Hyun Kuk Kim, Keun Ho Park, Eun Ho Choo, Chan Joon Kim, Min Chul Kim, Young Joon Hong, Sung Gyun Ahn, Joon-Hyung Doh, Sang Yeub Lee, Sang Don Park, Hyun-Jong Lee, Min Gyu Kang, Jin-Sin Koh, Yun-Kyeong Cho, Chang-Wook Nam, Hyun Sung Joh, Taek Kyu Park, Jeong Hoon Yang, Young Bin Song, Seung-Hyuk Choi, Myung Ho Jeong, Hyeon-Cheol Gwon, Joo-Yong Hahn, Joo Myung Lee","doi":"10.1161/CIRCINTERVENTIONS.123.013844","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.013844","url":null,"abstract":"<p><strong>Background: </strong>The Murray law-based quantitative flow ratio (μFR) is an emerging technique that requires only 1 projection of coronary angiography with similar accuracy to quantitative flow ratio (QFR). However, it has not been validated for the evaluation of noninfarct-related artery (non-IRA) in acute myocardial infarction (AMI) settings. Therefore, our study aimed to evaluate the diagnostic accuracy of μFR and the safety of deferring non-IRA lesions with μFR >0.80 in the setting of AMI.</p><p><strong>Methods: </strong>μFR and QFR were analyzed for non-IRA lesions of patients with AMI enrolled in the FRAME-AMI trial (Fractional Flow Reserve Versus Angiography-Guided Strategy for Management of Non-Infarction Related Artery Stenosis in Patients With Acute Myocardial Infarction), consisting of fractional flow reserve (FFR)-guided percutaneous coronary intervention and angiography-guided percutaneous coronary intervention groups. The diagnostic accuracy of μFR was compared with QFR and FFR. Patients were classified by the non-IRA μFR value of 0.80 as a cutoff value. The primary outcome was a vessel-oriented composite outcome, a composite of cardiac death, non-IRA-related myocardial infarction, and non-IRA-related repeat revascularization.</p><p><strong>Results: </strong>μFR and QFR analyses were feasible in 443 patients (552 lesions). μFR showed acceptable correlation with FFR (R=0.777; <i>P</i><0.001), comparable C-index with QFR to predict FFR ≤0.80 (μFR versus QFR: 0.926 versus 0.961, <i>P</i>=0.070), and shorter total analysis time (mean, 32.7 versus 186.9 s; <i>P</i><0.001). Non-IRA with μFR >0.80 and deferred percutaneous coronary intervention had a significantly lower risk of vessel-oriented composite outcome than non-IRA with performed percutaneous coronary intervention (3.4% versus 10.5%; hazard ratio, 0.37 [95% CI, 0.14-0.99]; <i>P</i>=0.048).</p><p><strong>Conclusions: </strong>In patients with multivessel AMI, μFR of non-IRA showed acceptable diagnostic accuracy comparable to that of QFR to predict FFR ≤0.80. Deferred non-IRA with μFR >0.80 showed a lower risk of vessel-oriented composite outcome than revascularized non-IRA.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02715518.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":6.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Drug-Coated Balloons in the Management of Coronary Artery Disease. 药物涂层球囊在冠状动脉疾病治疗中的应用。
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-05-01 Epub Date: 2024-05-21 DOI: 10.1161/CIRCINTERVENTIONS.123.013302
Serge Korjian, Killian J McCarthy, Emily A Larnard, Donald E Cutlip, Margaret B McEntegart, Ajay J Kirtane, Robert W Yeh

Drug-coated balloons (DCBs) are specialized coronary devices comprised of a semicompliant balloon catheter with an engineered coating that allows the delivery of antiproliferative agents locally to the vessel wall during percutaneous coronary intervention. Although DCBs were initially developed more than a decade ago, their potential in coronary interventions has recently sparked renewed interest, especially in the United States. Originally designed to overcome the limitations of conventional balloon angioplasty and stenting, they aim to match or even improve upon the outcomes of drug-eluting stents without leaving a permanent implant. Presently, in-stent restenosis is the condition with the most robust evidence supporting the use of DCBs. DCBs provide improved long-term vessel patency compared with conventional balloon angioplasty and may be comparable to drug-eluting stents without the need for an additional stent layer, supporting their use as a first-line therapy for in-stent restenosis. Beyond the treatment of in-stent restenosis, DCBs provide an additional tool for de novo lesions for a strategy that avoids a permanent metal scaffold, which may be especially useful for the management of technically challenging anatomies such as small vessels and bifurcations. DCBs might also be advantageous for patients with high bleeding risk due to the decreased necessity for extended antiplatelet therapy, and in patients with diabetes and patients with diffuse disease to minimize long-stented segments. Further studies are crucial to confirm these broader applications for DCBs and to further validate safety and efficacy.

药物涂层球囊(DCB)是一种专门的冠状动脉设备,由一个半顺应性球囊导管组成,导管上有一层工程涂层,可在经皮冠状动脉介入治疗过程中向血管壁局部输送抗增生药物。虽然 DCB 最初开发于十多年前,但其在冠状动脉介入治疗中的潜力最近再次引发了人们的兴趣,尤其是在美国。DCB 最初是为了克服传统球囊血管成形术和支架植入术的局限性而设计的,其目的是在不留下永久性植入物的情况下达到甚至改善药物洗脱支架的效果。目前,支架内再狭窄是支持使用 DCB 的最有力证据。与传统的球囊血管成形术相比,DCB 可改善血管的长期通畅性,而且无需额外的支架层就可与药物洗脱支架相媲美,因此支持将其作为治疗支架内再狭窄的一线疗法。除了治疗支架内再狭窄外,DCB 还为治疗新发病变提供了一种避免使用永久金属支架的额外工具,这对于治疗小血管和分叉等技术难度高的解剖结构尤其有用。由于减少了延长抗血小板治疗的必要性,DCB 对于出血风险较高的患者以及糖尿病患者和弥漫性疾病患者也可能具有优势,可以最大限度地减少长支架段。进一步的研究对于确认 DCB 的这些更广泛应用以及进一步验证其安全性和有效性至关重要。
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引用次数: 0
Prognostic Impact of Left Atrial Appendage Patency After Device Closure 设备关闭后左心房阑尾通畅度的预后影响
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-04-17 DOI: 10.1161/circinterventions.123.013579
Mu Chen, Peng-Cheng Yao, Zhen-Tao Fei, Qun-Shan Wang, Yi-Chi Yu, Peng-Pai Zhang, Wei Li, Rui Zhang, Bin-Feng Mo, Ming-Zhe Zhao, Yi Yu, Mei Yang, Yan Zhao, Chang-Qi Gong, Jian Sun, Yi-Gang Li
BACKGROUND:The prognostic impact of left atrial appendage (LAA) patency, including those with and without visible peri-device leak (PDL), post–LAA closure in patients with atrial fibrillation, remains elusive.METHODS:Patients with atrial fibrillation implanted with the WATCHMAN 2.5 device were prospectively enrolled. The device surveillance by cardiac computed tomography angiography was performed at 3 months post-procedure. Adverse events, including stroke/transient ischemic attack (TIA), major bleeding, cardiovascular death, all-cause death, and the combined major adverse events (MAEs), were compared between patients with complete closure and LAA patency.RESULTS:Among 519 patients with cardiac computed tomography angiography surveillance at 3 months post–LAA closure, 271 (52.2%) showed complete closure, and LAA patency was detected in 248 (47.8%) patients, including 196 (37.8%) with visible PDL and 52 (10.0%) without visible PDL. During a median of 1193 (787–1543) days follow-up, the presence of LAA patency was associated with increased risks of stroke/TIA (adjusted hazard ratio for baseline differences, 3.22 [95% CI, 1.17–8.83]; P=0.023) and MAEs (adjusted hazard ratio, 1.12 [95% CI, 1.06–1.17]; P=0.003). Specifically, LAA patency with visible PDL was associated with increased risks of stroke/TIA (hazard ratio, 3.66 [95% CI, 1.29–10.42]; P=0.015) and MAEs (hazard ratio, 3.71 [95% CI, 1.71–8.07]; P=0.001), although LAA patency without visible PDL showed higher risks of MAEs (hazard ratio, 3.59 [95% CI, 1.28–10.09]; P=0.015). Incidences of stroke/TIA (2.8% versus 3.0% versus 6.7% versus 22.2%; P=0.010), cardiovascular death (0.9% versus 0% versus 1.7% versus 11.1%; P=0.005), and MAEs (4.6% versus 9.0% versus 11.7% versus 22.2%; P=0.017) increased with larger PDL (0, >0 to ≤3, >3 to ≤5, or >5 mm). Older age and discontinuing antiplatelet therapy at 6 months were independent predictors of stroke/TIA and MAEs in patients with LAA patency.CONCLUSIONS:LAA patency detected by cardiac computed tomography angiography at 3 months post–LAA closure is associated with unfavorable prognosis in patients with atrial fibrillation implanted with WATCHMAN 2.5 device.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03788941.
背景:心房颤动患者左心房阑尾(LAA)闭合后,左心房阑尾(LAA)通畅性(包括有和无可见的装置周围泄漏(PDL))对预后的影响仍不明确。方法:前瞻性地招募了植入 WATCHMAN 2.5 装置的心房颤动患者。术后 3 个月通过心脏计算机断层扫描血管造影对装置进行监测。比较了完全闭合患者和 LAA 通畅患者的不良事件,包括中风/短暂性脑缺血发作(TIA)、大出血、心血管死亡、全因死亡和合并主要不良事件(MAEs)。结果:在LAA关闭术后3个月接受心脏计算机断层扫描血管造影监测的519名患者中,271人(52.2%)显示完全关闭,248人(47.8%)检测到LAA通畅,其中196人(37.8%)有可见PDL,52人(10.0%)无可见PDL。在中位 1193 (787-1543) 天的随访中,LAA 通畅与卒中/TIA 风险增加相关(基线差异调整后危险比为 3.22 [95% CI, 1.17-8.83];P=0.023)和 MAEs 风险增加相关(调整后危险比为 1.12 [95% CI, 1.06-1.17];P=0.003)。具体而言,可见 PDL 的 LAA 闭塞与卒中/TIA(危险比,3.66 [95% CI,1.29-10.42];P=0.015)和 MAEs(危险比,3.71 [95% CI,1.71-8.07];P=0.001)风险增加相关,但无可见 PDL 的 LAA 闭塞显示 MAEs 风险更高(危险比,3.59 [95% CI,1.28-10.09];P=0.015)。卒中/TIA(2.8% 对 3.0% 对 6.7% 对 22.2%;P=0.010)、心血管死亡(0.9% 对 0% 对 1.7% 对 11.1%;P=0.005)和 MAEs(4.6% 对 9.0% 对 11.7% 对 22.2%;P=0.017)的发生率随 PDL 的增大而增加(0、>0 至≤3、>3 至≤5 或 >5 mm)。结论:通过心脏计算机断层扫描血管造影检查发现,LAA闭合后3个月的LAA通畅与植入WATCHMAN 2.5设备的心房颤动患者的不良预后有关。REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier.NCT03788941:NCT03788941。
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引用次数: 0
Outcomes of Transcatheter Tricuspid Edge-to-Edge Repair in Patients With Right Ventricular Dysfunction 右心室功能障碍患者经导管三尖瓣边缘到边缘修复术的疗效
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-04-17 DOI: 10.1161/circinterventions.123.013156
Johanna Vogelhuber, Tetsu Tanaka, Refik Kavsur, Tadahiro Goto, Can Öztürk, Miriam Silaschi, Georg Nickenig, Sebastian Zimmer, Marcel Weber, Atsushi Sugiura
BACKGROUND:We assessed the safety profile of tricuspid transcatheter edge-to-edge repair (TEER) in patients with right ventricular (RV) dysfunction.METHODS:We identified patients undergoing TEER to treat tricuspid regurgitation from June 2015 to October 2021 and assessed tricuspid annular plane systolic excursion (TAPSE) and RV fractional area change (RVFAC). RV dysfunction was defined as TAPSE <17 mm and RVFAC <35%. The primary end point was 30-day mortality after TEER. We also investigated the change in the RV function in the early phase and clinical outcomes at 2 years.RESULTS:The study participants (n=262) were at high surgical risk (EuroSCORE II, 6.2% [interquartile range, 4.0%–10.3%]). Among them, 44 patients met the criteria of RV dysfunction. Thirty-day mortality was 3.2% in patients with normal RV function and 2.3% in patients with RV dysfunction (P=0.99). Tricuspid regurgitation reduction to ≤2+ was consistently achieved irrespective of RV dysfunction (76.5% versus 70.5%; P=0.44). TAPSE and RVFAC declined after TEER in patients with normal RV function (TAPSE, 19.0±4.7 to 17.9±4.5 mm; P=0.001; RVFAC, 46.2%±8.1% to 40.3%±9.7%; P<0.001). In contrast, those parameters were unchanged or tended to increase in patients with RV dysfunction (TAPSE, 13.2±2.3 to 15.3±4.7 mm; P=0.011; RVFAC, 29.6%±4.1% to 31.6%±8.3%; P=0.14). Two years after TEER, compared with patients with normal RV function, patients with RV dysfunction had significantly higher mortality (27.0% versus 56.3%; P<0.001).CONCLUSIONS:TEER was safe and feasible to treat tricuspid regurgitation in patients with RV dysfunction. The decline in the RV function was observed in patients with normal RV function but not in patients with RV dysfunction.
背景:我们评估了右心室(RV)功能障碍患者接受三尖瓣经导管边缘到边缘修补术(TEER)的安全性。方法:我们确定了2015年6月至2021年10月期间接受TEER治疗三尖瓣反流的患者,并评估了三尖瓣瓣环平面收缩期偏移(TAPSE)和RV分区面积变化(RVFAC)。RV 功能障碍的定义是 TAPSE <17 mm 和 RVFAC <35% 。主要终点是 TEER 后 30 天的死亡率。我们还调查了早期阶段 RV 功能的变化以及 2 年后的临床结果。结果:研究参与者(n=262)的手术风险较高(EuroSCORE II,6.2% [四分位数范围,4.0%-10.3%])。其中,44 名患者符合 RV 功能障碍的标准。RV 功能正常患者的 30 天死亡率为 3.2%,RV 功能障碍患者的 30 天死亡率为 2.3%(P=0.99)。无论 RV 功能障碍与否,三尖瓣反流均能持续减少至≤2+(76.5% 对 70.5%;P=0.44)。RV 功能正常的患者在 TEER 后 TAPSE 和 RVFAC 下降(TAPSE,19.0±4.7 mm 至 17.9±4.5 mm;P=0.001;RVFAC,46.2%±8.1% 至 40.3%±9.7%;P<0.001)。相比之下,RV 功能障碍患者的这些参数没有变化或呈上升趋势(TAPSE,13.2±2.3 至 15.3±4.7 mm;P=0.011;RVFAC,29.6%±4.1% 至 31.6%±8.3%;P=0.14)。结论:TEER治疗RV功能障碍患者的三尖瓣反流是安全可行的。结论:TEER治疗三尖瓣反流在RV功能障碍患者中安全可行,但在RV功能正常的患者中观察到RV功能下降,而在RV功能障碍患者中未观察到。
{"title":"Outcomes of Transcatheter Tricuspid Edge-to-Edge Repair in Patients With Right Ventricular Dysfunction","authors":"Johanna Vogelhuber, Tetsu Tanaka, Refik Kavsur, Tadahiro Goto, Can Öztürk, Miriam Silaschi, Georg Nickenig, Sebastian Zimmer, Marcel Weber, Atsushi Sugiura","doi":"10.1161/circinterventions.123.013156","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013156","url":null,"abstract":"BACKGROUND:We assessed the safety profile of tricuspid transcatheter edge-to-edge repair (TEER) in patients with right ventricular (RV) dysfunction.METHODS:We identified patients undergoing TEER to treat tricuspid regurgitation from June 2015 to October 2021 and assessed tricuspid annular plane systolic excursion (TAPSE) and RV fractional area change (RVFAC). RV dysfunction was defined as TAPSE &lt;17 mm and RVFAC &lt;35%. The primary end point was 30-day mortality after TEER. We also investigated the change in the RV function in the early phase and clinical outcomes at 2 years.RESULTS:The study participants (n=262) were at high surgical risk (EuroSCORE II, 6.2% [interquartile range, 4.0%–10.3%]). Among them, 44 patients met the criteria of RV dysfunction. Thirty-day mortality was 3.2% in patients with normal RV function and 2.3% in patients with RV dysfunction (<i>P</i>=0.99). Tricuspid regurgitation reduction to ≤2+ was consistently achieved irrespective of RV dysfunction (76.5% versus 70.5%; <i>P</i>=0.44). TAPSE and RVFAC declined after TEER in patients with normal RV function (TAPSE, 19.0±4.7 to 17.9±4.5 mm; <i>P</i>=0.001; RVFAC, 46.2%±8.1% to 40.3%±9.7%; <i>P</i>&lt;0.001). In contrast, those parameters were unchanged or tended to increase in patients with RV dysfunction (TAPSE, 13.2±2.3 to 15.3±4.7 mm; <i>P</i>=0.011; RVFAC, 29.6%±4.1% to 31.6%±8.3%; <i>P</i>=0.14). Two years after TEER, compared with patients with normal RV function, patients with RV dysfunction had significantly higher mortality (27.0% versus 56.3%; <i>P</i>&lt;0.001).CONCLUSIONS:TEER was safe and feasible to treat tricuspid regurgitation in patients with RV dysfunction. The decline in the RV function was observed in patients with normal RV function but not in patients with RV dysfunction.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cardiac Damage in Degenerative Mitral Regurgitation Treated With Transcatheter Mitral Edge-to-Edge Repair 经导管二尖瓣边缘到边缘修复术治疗退行性二尖瓣反流的心脏损伤
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-04-17 DOI: 10.1161/circinterventions.123.013794
Atsushi Sugiura, Masanori Yamamoto, Mike Saji, Masahiko Asami, Yusuke Enta, Masaki Nakashima, Shinichi Shirai, Masaki Izumo, Shingo Mizuno, Yusuke Watanabe, Makoto Amaki, Kazuhisa Kodama, Junichi Yamaguchi, Yoshifumi Nakajima, Toru Naganuma, Hiroki Bota, Yohei Ohno, Masahiro Yamawaki, Hiroshi Ueno, Kazuki Mizutani, Yuya Adachi, Toshiaki Otsuka, Shunsuke Kubo, Georg Nickenig, Kentaro Hayashida, on behalf of the OCEAN-Mitral Investigators
BACKGROUND:The extent of cardiac damage and its association with clinical outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) for degenerative mitral regurgitation remains unclear. This study was aimed to investigate cardiac damage in patients with degenerative mitral regurgitation treated with TEER and its association with outcomes.METHODS:We analyzed patients with degenerative mitral regurgitation treated with TEER in the Optimized Catheter Valvular Intervention-Mitral registry, which is a prospective, multicenter observational data collection in Japan. The study subjects were classified according to the extent of cardiac damage at baseline: no extravalvular cardiac damage (stage 0), mild left ventricular or left atrial damage (stage 1), moderate left ventricular or left atrial damage (stage 2), or right heart damage (stage 3). Two-year mortality after TEER was compared using Kaplan-Meier analysis.RESULTS:Out of 579 study participants, 8 (1.4%) were classified as stage 0, 76 (13.1%) as stage 1, 319 (55.1%) as stage 2, and 176 (30.4%) as stage 3. Two-year survival was 100% in stage 0, 89.5% in stage 1, 78.9% in stage 2, and 75.3% in stage 3 (P=0.013). Compared with stage 0 to 1, stage 2 (hazard ratio, 3.34 [95% CI, 1.03–10.81]; P=0.044) and stage 3 (hazard ratio, 4.51 [95% CI, 1.37–14.85]; P=0.013) were associated with increased risk of 2-year mortality after TEER. Significant reductions in heart failure rehospitalization rate and New York Heart Association functional scale were observed following TEER (both, P<0.001), irrespective of the stage of cardiac damage.CONCLUSIONS:Advanced cardiac damage is associated with an increased risk of mortality in patients undergoing TEER for degenerative mitral regurgitation.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: UMIN000023653.
背景:接受经导管边缘到边缘修补术(TEER)治疗退行性二尖瓣反流患者的心脏损伤程度及其与临床预后的关系仍不清楚。方法:我们分析了优化导管瓣膜介入治疗-二尖瓣注册中接受经导管边缘到边缘修补术(TEER)治疗的退行性二尖瓣反流患者。研究对象根据基线时的心脏损伤程度进行分类:无瓣外心脏损伤(0 期)、轻度左心室或左心房损伤(1 期)、中度左心室或左心房损伤(2 期)或右心损伤(3 期)。结果:在579名研究参与者中,8人(1.4%)被归为0期,76人(13.1%)为1期,319人(55.1%)为2期,176人(30.4%)为3期。0期患者的两年生存率为100%,1期为89.5%,2期为78.9%,3期为75.3%(P=0.013)。与0至1期相比,2期(危险比为3.34 [95% CI, 1.03-10.81];P=0.044)和3期(危险比为4.51 [95% CI, 1.37-14.85];P=0.013)与TEER后2年死亡风险增加有关。无论心脏损伤程度如何,TEER术后心衰再住院率和纽约心脏协会功能量表均显著降低(均为P<0.001)。结论:晚期心脏损伤与因退行性二尖瓣反流接受TEER术的患者死亡风险增加有关。注册:URL:https://www.clinicaltrials.gov;唯一标识符:UMIN000023653。
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引用次数: 0
Factors Associated With Coronary Angiography Performed Within 6 Months of Randomization to the Conservative Strategy in the ISCHEMIA Trial 与 ISCHEMIA 试验中随机采取保守策略后 6 个月内进行冠状动脉造影术相关的因素
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-04-17 DOI: 10.1161/circinterventions.123.013435
Radosław Pracoń, John A. Spertus, Samuel Broderick, Sripal Bangalore, Frank W. Rockhold, Witold Ruzyllo, Elena Demchenko, Thuraia Nageh, Gabriel Blacher Grossman, Kreton Mavromatis, Cholenahally N. Manjunath, Paola E.P. Smanio, Gregg W. Stone, G.B. John Mancini, William E. Boden, Jonathan D. Newman, Harmony R. Reynolds, Judith S. Hochman, David J. Maron
BACKGROUND:ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) did not find an overall reduction in cardiovascular events with an initial invasive versus conservative management strategy in chronic coronary disease; however, there were conservative strategy participants who underwent invasive coronary angiography early postrandomization (within 6 months). Identifying factors associated with angiography in conservative strategy participants will inform clinical decision-making in patients with chronic coronary disease.METHODS:Factors independently associated with angiography performed within 6 months of randomization were identified using Fine and Gray proportional subdistribution hazard models, including demographics, region of randomization, medical history, risk factor control, symptoms, ischemia severity, coronary anatomy based on protocol-mandated coronary computed tomography angiography, and medication use.RESULTS:Among 2591 conservative strategy participants, angiography within 6 months of randomization occurred in 8.7% (4.7% for a suspected primary end point event, 1.6% for persistent symptoms, and 2.6% due to protocol nonadherence) and was associated with the following baseline characteristics: enrollment in Europe versus Asia (hazard ratio [HR], 1.81 [95% CI, 1.14–2.86]), daily and weekly versus no angina (HR, 5.97 [95% CI, 2.78–12.86] and 2.63 [95% CI, 1.51–4.58], respectively), poor to fair versus good to excellent health status (HR, 2.02 [95% CI, 1.23–3.32]) assessed with Seattle Angina Questionnaire, and new/more frequent angina prerandomization (HR, 1.80 [95% CI, 1.34–2.40]). Baseline low-density lipoprotein cholesterol <70 mg/dL was associated with a lower risk of angiography (HR, 0.65 [95% CI, 0.46–0.91) but not baseline ischemia severity nor the presence of multivessel or proximal left anterior descending artery stenosis >70% on coronary computed tomography angiography.CONCLUSIONS:Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in <10% of patients. It was associated with frequent or increasing baseline angina and poor quality of life but not with objective markers of disease severity. Well-controlled baseline low-density lipoprotein cholesterol was associated with a reduced likelihood of angiography. These findings point to the importance of a comprehensive assessment of symptoms and a review of guideline-directed medical therapy goals when deciding the initial treatment strategy for chronic coronary disease.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.
背景:ISCHEMIA(国际医疗与侵入性方法健康效果比较研究)并未发现慢性冠心病初始侵入性管理策略与保守性管理策略相比,心血管事件总体上有所减少;但是,有一些保守性策略参与者在随机化后早期(6 个月内)接受了侵入性冠状动脉造影术。确定保守策略参与者接受血管造影术的相关因素将为慢性冠心病患者的临床决策提供参考。方法:使用 Fine 和 Gray 比例子分布危险模型确定了与随机化后 6 个月内进行血管造影术独立相关的因素,包括人口统计学、随机化地区、病史、危险因素控制、症状、缺血严重程度、基于方案规定的冠状动脉计算机断层扫描血管造影术的冠状动脉解剖结构以及药物使用。7%(4.7%因疑似主要终点事件,1.6%因症状持续存在,2.6%因不遵守方案),并与以下基线特征相关:在欧洲入组与在亚洲入组(危险比 [HR],1.81 [95% CI,1.14-2.86]),每日和每周心绞痛与无心绞痛(HR,5.97[95%CI,2.78-12.86]和2.63[95%CI,1.51-4.58])、西雅图心绞痛问卷评估的健康状况从差到一般与从好到优(HR,2.02[95%CI,1.23-3.32])以及随机化前新发/更频繁心绞痛(HR,1.80[95%CI,1.34-2.40])。基线低密度脂蛋白胆固醇 70 mg/dL 与较低的血管造影风险相关(HR,0.65 [95% CI,0.46-0.91]),但与基线缺血严重程度、冠状动脉计算机断层扫描血管造影显示的多血管或左前降支动脉近端狭窄 70% 无关。结论:在随机采取保守策略的 ISCHEMIA 参与者中,有<10%的患者在随机化后 6 个月内进行了血管造影。这与频繁发生或基线心绞痛和生活质量差有关,但与疾病严重程度的客观指标无关。基线低密度脂蛋白胆固醇控制良好与血管造影的可能性降低有关。这些研究结果表明,在决定慢性冠状动脉疾病的初始治疗策略时,对症状进行全面评估并审查指南指导的医疗目标非常重要。注册:URL:https://www.clinicaltrials.gov;唯一标识符:NCT01471522。
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引用次数: 0
Evaluation of Instantaneous Wave-Free Ratio and Fractional Flow Reserve in Severe Aortic Valve Stenosis 评估重度主动脉瓣狭窄患者的瞬时无波比和分流储备量
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-04-17 DOI: 10.1161/circinterventions.123.013237
Ha Hye Jo, Do-Yoon Kang, Joong Min Lee, So-Min Lim, Young-Sun Park, Yeonwoo Choi, Hoyun Kim, Jinho Lee, Jung-Min Ahn, Duk-Woo Park, Seung-Jung Park
BACKGROUND:The optimal functional evaluation of coronary artery stenosis in patients with severe aortic stenosis (AS) has not been established. The objective of the study was to evaluate the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in patients with and without severe AS.METHODS:We retrospectively investigated 395 lesions in 293 patients with severe AS and 2257 lesions in 1882 patients without severe AS between 2010 and 2022 from a subgroup of the Interventional Cardiology Research In-Cooperation Society FFR Registry. All patients had FFR values, and iFR was analyzed post hoc using dedicated software only in lesions with adequate resting pressure curves (311 lesions in patients with severe AS and 2257 lesions in patients with nonsevere AS).RESULTS:The incidence of iFR ≤0.89 was 66.6% and 31.8% (P<0.001), while the incidence of FFR ≤0.80 was 45.3% and 43.9% (P=0.60) in the severe AS group and the nonsevere AS group, respectively. In the severe AS group, most lesions (95.2%) with iFR >0.89 had FFR >0.80, while 36.2% of lesions with iFR ≤0.89 had FFR >0.80. During a median follow-up of 2 years, FFR ≤0.80 was significantly associated with deferred lesion failure (adjusted hazard ratio, 2.71 [95% CI, 1.08–6.80]; P=0.034), while iFR ≤0.89 showed no prognostic value (adjusted hazard ratio, 1.31 [95% CI, 0.47–3.60]; P=0.60) in the severe AS group. Lesions with iFR ≤0.89 and FFR >0.80, in particular, were not associated with a higher rate of deferred lesion failure at 3 years compared with lesions with iFR >0.89 (15.4% versus 17.0%; P=0.58).CONCLUSIONS:This study suggested that FFR appears to be less affected by the presence of severe AS and is more associated with prognosis. iFR may overestimate the functional severity of coronary artery disease without prognostic significance, yet it can be useful for excluding significant stenosis in patients with severe AS.
背景:严重主动脉瓣狭窄(AS)患者冠状动脉狭窄的最佳功能评估尚未确定。方法:我们回顾性调查了 2010 年至 2022 年间介入心脏病学研究合作协会 FFR 注册分组中 293 例重度 AS 患者的 395 个病变和 1882 例非重度 AS 患者的 2257 个病变。结果:在重度AS组和非重度AS组中,iFR≤0.89的发生率分别为66.6%和31.8%(P<0.001),而FFR≤0.80的发生率分别为45.3%和43.9%(P=0.60)。在重度AS组中,iFR为0.89的大多数病变(95.2%)的FFR为0.80,而iFR≤0.89的病变中有36.2%的FFR为0.80。在中位随访2年期间,FFR≤0.80与延迟病变失败显著相关(调整后危险比为2.71 [95% CI, 1.08-6.80];P=0.034),而在重度AS组中,iFR≤0.89没有预后价值(调整后危险比为1.31 [95% CI, 0.47-3.60];P=0.60)。iFR≤0.89和FFR >0.80的病变与iFR >0.89的病变相比,3年时的延迟病变失败率更高(15.4%对17.0%;P=0.58)。iFR可能会高估冠状动脉疾病的功能严重程度,但对预后没有意义,但对排除严重AS患者的明显狭窄很有用。
{"title":"Evaluation of Instantaneous Wave-Free Ratio and Fractional Flow Reserve in Severe Aortic Valve Stenosis","authors":"Ha Hye Jo, Do-Yoon Kang, Joong Min Lee, So-Min Lim, Young-Sun Park, Yeonwoo Choi, Hoyun Kim, Jinho Lee, Jung-Min Ahn, Duk-Woo Park, Seung-Jung Park","doi":"10.1161/circinterventions.123.013237","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013237","url":null,"abstract":"BACKGROUND:The optimal functional evaluation of coronary artery stenosis in patients with severe aortic stenosis (AS) has not been established. The objective of the study was to evaluate the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in patients with and without severe AS.METHODS:We retrospectively investigated 395 lesions in 293 patients with severe AS and 2257 lesions in 1882 patients without severe AS between 2010 and 2022 from a subgroup of the Interventional Cardiology Research In-Cooperation Society FFR Registry. All patients had FFR values, and iFR was analyzed post hoc using dedicated software only in lesions with adequate resting pressure curves (311 lesions in patients with severe AS and 2257 lesions in patients with nonsevere AS).RESULTS:The incidence of iFR ≤0.89 was 66.6% and 31.8% (<i>P</i>&lt;0.001), while the incidence of FFR ≤0.80 was 45.3% and 43.9% (<i>P</i>=0.60) in the severe AS group and the nonsevere AS group, respectively. In the severe AS group, most lesions (95.2%) with iFR &gt;0.89 had FFR &gt;0.80, while 36.2% of lesions with iFR ≤0.89 had FFR &gt;0.80. During a median follow-up of 2 years, FFR ≤0.80 was significantly associated with deferred lesion failure (adjusted hazard ratio, 2.71 [95% CI, 1.08–6.80]; <i>P</i>=0.034), while iFR ≤0.89 showed no prognostic value (adjusted hazard ratio, 1.31 [95% CI, 0.47–3.60]; <i>P</i>=0.60) in the severe AS group. Lesions with iFR ≤0.89 and FFR &gt;0.80, in particular, were not associated with a higher rate of deferred lesion failure at 3 years compared with lesions with iFR &gt;0.89 (15.4% versus 17.0%; <i>P</i>=0.58).CONCLUSIONS:This study suggested that FFR appears to be less affected by the presence of severe AS and is more associated with prognosis. iFR may overestimate the functional severity of coronary artery disease without prognostic significance, yet it can be useful for excluding significant stenosis in patients with severe AS.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140617486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials PCI术后接受简短双联抗血小板疗法患者的癌症风险负担:多中心对照高出血风险试验分析
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-04-16 DOI: 10.1161/circinterventions.122.013000
Carlos M. Campos, Roxana Mehran, Davide Capodanno, Ruth Owen, Stephan Windecker, Olivier Varenne, Gregg W. Stone, Marco Valgimigli, Ludhmila Abrahão Hajjar, Roberto Kalil Filho, Keith Oldroyd, Marie-Claude Morice, Philip Urban, Alexandre Abizaid
BACKGROUND:Oncological patients with coronary artery disease face an elevated risk of hemorrhagic and ischemic events following percutaneous coronary intervention. Despite medical guidelines recommending minimal dual antiplatelet therapy (DAPT) duration for patients with cancer, dedicated data on abbreviated DAPT in this population is lacking. This study aims to evaluate the occurrence of ischemic and hemorrhagic events in patients with cancer compared with other high-bleeding risk individuals.METHODS:Patient-level data from 4 high-bleeding risk coronary drug-eluting stent studies (ONYX One, LEADERS FREE, LEADERS FREE II, and SENIOR trials) treated with short DAPT were analyzed. The comparison focused on patients with high-bleeding risk with and without cancer, assessing 1-year rates of net adverse clinical events (all-cause death, myocardial infarction, stroke, revascularization, and Bleeding Academic Research Consortium [BARC] types 3 to 5 bleeding) and major adverse clinical events (all-cause death, myocardial infarction, stroke).RESULTS:A total of 5232 patients were included, of whom 574 individuals had cancer, and 4658 were at high-bleeding risk without previous cancer. Despite being younger with fewer risk factors, patients with cancer had higher net adverse clinical event (HR, 1.25; P=0.01) and major adverse clinical event (HR, 1.26; P=0.02), primarily driven by all-cause mortality and major bleeding (BARC 3–5), but not myocardial infarction, stroke, stent thrombosis, or repeat revascularization. Cancer was an independent predictor of net adverse clinical event (P=0.005), major adverse clinical event (P=0.01), and major bleeding (P=0.03).CONCLUSIONS:The present work is the first report on abbreviated DAPT dedicated to patients with cancer. Cancer is a major marker of adverse outcomes and these events had high lethality. Despite short DAPT, patients with cancer experienced higher rates of major bleeding compared with patients without cancer with high-bleeding risk, which occurred mainly after DAPT discontinuation. These findings reinforce the need for a more detailed and individualized stratification of those patients.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03344653, NCT01623180, NCT02843633, NCT0284.
背景:患有冠状动脉疾病的肿瘤患者在经皮冠状动脉介入治疗后发生出血和缺血性事件的风险较高。尽管医疗指南建议癌症患者尽量缩短双联抗血小板疗法(DAPT)的疗程,但目前尚缺乏关于该人群缩短DAPT疗程的专门数据。本研究旨在评估癌症患者与其他高出血风险人群相比发生缺血性和出血性事件的情况。方法:分析了 4 项高出血风险冠状动脉药物洗脱支架研究(ONYX One、LEADERS FREE、LEADERS FREE II 和 SENIOR 试验)中采用短 DAPT 治疗的患者水平数据。结果:共纳入了 5232 例患者,其中 574 例患有癌症,4658 例为高出血风险且未患过癌症的患者。尽管癌症患者更年轻,风险因素更少,但他们的净不良临床事件(HR,1.25;P=0.01)和主要不良临床事件(HR,1.26;P=0.02)却更高,主要原因是全因死亡率和大出血(BARC 3-5),而不是心肌梗死、中风、支架血栓或重复血管再通。癌症是净不良临床事件(P=0.005)、主要不良临床事件(P=0.01)和大出血(P=0.03)的独立预测因素。癌症是不良后果的主要标志,这些事件的致死率很高。尽管DAPT时间较短,但与出血风险较高的非癌症患者相比,癌症患者的大出血率较高,且主要发生在DAPT停药后。这些发现加强了对这些患者进行更详细和个体化分层的必要性。注册:URL:https://www.clinicaltrials.gov;唯一标识符:NCT03344653、NCT01623180、NCT02843633、NCT0284。
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引用次数: 0
Large Animal Translational Validation of 3 Mitral Valve Repair Operations for Mitral Regurgitation Using a Mitral Valve Prolapse Model: A Comprehensive In Vivo Biomechanical Engineering Analysis 使用二尖瓣脱垂模型对治疗二尖瓣反流的 3 种二尖瓣修复手术进行大型动物转化验证:体内生物力学工程综合分析
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-04-16 DOI: 10.1161/circinterventions.123.013196
Yuanjia Zhu, Shin Yajima, Matthew H. Park, Akshay Venkatesh, Charles J. Stark, Nicholas A. Tran, Sabrina K. Walsh, Sidarth Ethiraj, Robert J. Wilkerson, Luca E. Lin, Seung Hyun Lee, Kate Y. Gates, Justin D. Arthur, Sam W. Baker, Danielle M. Mullis, Catherine A. Wu, Shun Harima, Bipul Pokhrel, Dominique Resuello, Hunter Bergamasco, Matthew A. Wu, Basil M. Baccouche, Pearly K. Pandya, Stefan Elde, Hanjay Wang, Y. Joseph Woo
BACKGROUND:Various mitral repair techniques have been described. Though these repair techniques can be highly effective when performed correctly in suitable patients, limited quantitative biomechanical data are available. Validation and thorough biomechanical evaluation of these repair techniques from translational large animal in vivo studies in a standardized, translatable fashion are lacking. We sought to evaluate and validate biomechanical differences among different mitral repair techniques and further optimize repair operations using a large animal mitral valve prolapse model.METHODS:Male Dorset sheep (n=20) had P2 chordae severed to create the mitral valve prolapse model. Fiber Bragg grating force sensors were implanted to measure chordal forces. Ten sheep underwent 3 randomized, paired mitral valve repair operations: neochord repair, nonresectional leaflet remodeling, and triangular resection. The other 10 sheep underwent neochord repair with 2, 4, and 6 neochordae. Data were collected at baseline, mitral valve prolapse, and after each repair.RESULTS:All mitral repair techniques successfully eliminated regurgitation. Compared with mitral valve prolapse (0.54±0.18 N), repair using neochord (0.37±0.20 N; P=0.02) and remodeling techniques (0.30±0.15 N; P=0.001) reduced secondary chordae peak force. Neochord repair further decreased primary chordae peak force (0.21±0.14 N) to baseline levels (0.20±0.17 N; P=0.83), and was associated with lower primary chordae peak force compared with the remodeling (0.34±0.18 N; P=0.02) and triangular resectional techniques (0.36±0.27 N; P=0.03). Specifically, repair using 2 neochordae resulted in higher peak primary chordal forces (0.28±0.21 N) compared with those using 4 (0.22±0.16 N; P=0.02) or 6 neochordae (0.19±0.16 N; P=0.002). No difference in peak primary chordal forces was observed between 4 and 6 neochordae (P=0.05). Peak forces on the neochordae were the lowest using 6 neochordae (0.09±0.11 N) compared with those of 4 neochordae (0.15±0.14 N; P=0.01) and 2 neochordae (0.29±0.18 N; P=0.001).CONCLUSIONS:Significant biomechanical differences were observed underlying different mitral repair techniques in a translational large animal model. Neochord repair was associated with the lowest primary chordae peak force compared to the remodeling and triangular resectional techniques. Additionally, neochord repair using at least 4 neochordae was associated with lower chordal forces on the primary chordae and the neochordae. This study provided key insights about mitral valve repair optimization and may further improve repair durability.
背景:目前已有多种二尖瓣修复技术。虽然这些修复技术如果在合适的患者身上正确实施会非常有效,但现有的定量生物力学数据非常有限。目前还缺乏标准化、可转化的大型动物体内研究对这些修复技术进行验证和全面的生物力学评估。我们试图评估和验证不同二尖瓣修复技术之间的生物力学差异,并使用大型动物二尖瓣脱垂模型进一步优化修复操作。植入光纤布拉格光栅力传感器以测量弦力。10 只绵羊接受了 3 种随机配对的二尖瓣修复手术:新腱膜修复术、非切除瓣叶重塑术和三角切除术。另外 10 只绵羊分别接受了 2、4 和 6 根新索的新索修补术。结果:所有二尖瓣修复技术都成功消除了反流。与二尖瓣脱垂(0.54±0.18 N)相比,使用新腱索(0.37±0.20 N;P=0.02)和重塑技术(0.30±0.15 N;P=0.001)进行修复可降低次级腱索峰值力。新弦修复进一步将初级腱索峰值力(0.21±0.14 N)降至基线水平(0.20±0.17 N;P=0.83),与重塑技术(0.34±0.18 N;P=0.02)和三角切除技术(0.36±0.27 N;P=0.03)相比,初级腱索峰值力更低。具体而言,与使用4个(0.22±0.16 N;P=0.02)或6个新心轴(0.19±0.16 N;P=0.002)的修复方法相比,使用2个新心轴的修复方法可获得更高的主弦力峰值(0.28±0.21 N)。4 根和 6 根新弦轴的主弦力峰值没有差异(P=0.05)。结论:在大型动物转化模型中,不同二尖瓣修复技术的生物力学差异显著。与重塑技术和三角切除技术相比,新腱索修复术与最低的初级腱索峰值力相关。此外,使用至少 4 根新腱膜进行新腱膜修复与主腱膜和新腱膜上较低的腱膜力有关。这项研究为二尖瓣修复的优化提供了重要见解,并可能进一步提高修复的耐久性。
{"title":"Large Animal Translational Validation of 3 Mitral Valve Repair Operations for Mitral Regurgitation Using a Mitral Valve Prolapse Model: A Comprehensive In Vivo Biomechanical Engineering Analysis","authors":"Yuanjia Zhu, Shin Yajima, Matthew H. Park, Akshay Venkatesh, Charles J. Stark, Nicholas A. Tran, Sabrina K. Walsh, Sidarth Ethiraj, Robert J. Wilkerson, Luca E. Lin, Seung Hyun Lee, Kate Y. Gates, Justin D. Arthur, Sam W. Baker, Danielle M. Mullis, Catherine A. Wu, Shun Harima, Bipul Pokhrel, Dominique Resuello, Hunter Bergamasco, Matthew A. Wu, Basil M. Baccouche, Pearly K. Pandya, Stefan Elde, Hanjay Wang, Y. Joseph Woo","doi":"10.1161/circinterventions.123.013196","DOIUrl":"https://doi.org/10.1161/circinterventions.123.013196","url":null,"abstract":"BACKGROUND:Various mitral repair techniques have been described. Though these repair techniques can be highly effective when performed correctly in suitable patients, limited quantitative biomechanical data are available. Validation and thorough biomechanical evaluation of these repair techniques from translational large animal in vivo studies in a standardized, translatable fashion are lacking. We sought to evaluate and validate biomechanical differences among different mitral repair techniques and further optimize repair operations using a large animal mitral valve prolapse model.METHODS:Male Dorset sheep (n=20) had P2 chordae severed to create the mitral valve prolapse model. Fiber Bragg grating force sensors were implanted to measure chordal forces. Ten sheep underwent 3 randomized, paired mitral valve repair operations: neochord repair, nonresectional leaflet remodeling, and triangular resection. The other 10 sheep underwent neochord repair with 2, 4, and 6 neochordae. Data were collected at baseline, mitral valve prolapse, and after each repair.RESULTS:All mitral repair techniques successfully eliminated regurgitation. Compared with mitral valve prolapse (0.54±0.18 N), repair using neochord (0.37±0.20 N; <i>P</i>=0.02) and remodeling techniques (0.30±0.15 N; <i>P</i>=0.001) reduced secondary chordae peak force. Neochord repair further decreased primary chordae peak force (0.21±0.14 N) to baseline levels (0.20±0.17 N; <i>P</i>=0.83), and was associated with lower primary chordae peak force compared with the remodeling (0.34±0.18 N; <i>P</i>=0.02) and triangular resectional techniques (0.36±0.27 N; <i>P</i>=0.03). Specifically, repair using 2 neochordae resulted in higher peak primary chordal forces (0.28±0.21 N) compared with those using 4 (0.22±0.16 N; <i>P</i>=0.02) or 6 neochordae (0.19±0.16 N; <i>P</i>=0.002). No difference in peak primary chordal forces was observed between 4 and 6 neochordae (<i>P</i>=0.05). Peak forces on the neochordae were the lowest using 6 neochordae (0.09±0.11 N) compared with those of 4 neochordae (0.15±0.14 N; <i>P</i>=0.01) and 2 neochordae (0.29±0.18 N; <i>P</i>=0.001).CONCLUSIONS:Significant biomechanical differences were observed underlying different mitral repair techniques in a translational large animal model. Neochord repair was associated with the lowest primary chordae peak force compared to the remodeling and triangular resectional techniques. Additionally, neochord repair using at least 4 neochordae was associated with lower chordal forces on the primary chordae and the neochordae. This study provided key insights about mitral valve repair optimization and may further improve repair durability.","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":null,"pages":null},"PeriodicalIF":5.6,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140616148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction: The PiCSO-AMI-I Trial 急性心肌梗死中的压力控制间歇性冠状动脉窦闭塞(PiCSO):PiCSO-AMI-I 试验
IF 5.6 1区 医学 Q1 Medicine Pub Date : 2024-04-16 DOI: 10.1161/circinterventions.123.013675
Giovanni Luigi De Maria, John P. Greenwood, Azfar G. Zaman, Didier Carrié, Pierre Coste, Marco Valgimigli, Miles Behan, Colin Berry, Andrejs Erglis, Vasileios F. Panoulas, Eric Van Belle, Christian Juhl Terkelsen, Lukas Hunziker Munsch, Ajay K. Jain, Jens Flensted Lassen, Nick Palmer, Gregg W. Stone, Adrian P. Banning
BACKGROUND:Primary percutaneous coronary intervention (pPCI) has improved clinical outcomes in patients with ST-segment-elevation myocardial infarction. However, as many as 50% of patients still have suboptimal myocardial reperfusion and experience extensive myocardial necrosis. The PiCSO-AMI-I trial (Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I) evaluated whether PiCSO therapy can further reduce myocardial infarct size (IS) in patients undergoing pPCI.METHODS:Patients with anterior ST-segment–elevation myocardial infarction and Thrombolysis in Myocardial Infarction flow 0-1 were randomized at 16 European centers to PiCSO-assisted pPCI or conventional pPCI. The PiCSO Impulse Catheter (8Fr balloon-tipped catheter) was inserted via femoral venous access after antegrade flow restoration of the culprit vessel and before proceeding with stenting. The primary end point was the difference in IS (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance. Secondary end points were the extent of microvascular obstruction and intramyocardial hemorrhage at 5 days and IS at 6 months.RESULTS:Among 145 randomized patients, 72 received PiCSO-assisted pPCI and 73 conventional pPCI. No differences were observed in IS at 5 days (27.2%±12.4% versus 28.3%±11.45%; P=0.59) and 6 months (19.2%±10.1% versus 18.8%±7.7%; P=0.83), nor were differences between PiCSO-treated and control patients noted in terms of the occurrence of microvascular obstruction (67.2% versus 64.6%; P=0.85) or intramyocardial hemorrhage (55.7% versus 60%; P=0.72). The study was prematurely discontinued by the sponsor with no further clinical follow-up beyond 6 months. However, up to 6 months of PiCSO use appeared safe with no device-related adverse events.CONCLUSIONS:In this prematurely discontinued randomized trial, PiCSO therapy as an adjunct to pPCI did not reduce IS when compared with conventional pPCI in patients with anterior ST-segment–elevation myocardial infarction. PiCSO use was associated with increased procedural time and contrast but no increase in adverse events up to 6 months.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03625869.
背景:原发性经皮冠状动脉介入治疗(pPCI)改善了ST段抬高型心肌梗死患者的临床疗效。然而,仍有多达 50% 的患者心肌再灌注效果不佳,并出现大面积心肌坏死。PiCSO-AMI-I试验(Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I)评估了PiCSO疗法能否进一步缩小接受pPCI患者的心肌梗死面积(IS)。PiCSO脉冲导管(8Fr球囊顶端导管)是在罪魁祸首血管逆行血流恢复后,通过股静脉入路插入,然后再进行支架植入术。主要终点是 5 天后通过心脏磁共振测量的 IS 差异(以左心室质量百分比表示)。结果:在 145 位随机患者中,72 位接受了 PiCSO 辅助的 pPCI,73 位接受了传统的 pPCI。在 5 天(27.2%±12.4% 对 28.3%±11.45%;P=0.59)和 6 个月(19.2%±10.1% 对 18.8%±7.7%;P=0.83)的 IS 和微血管阻塞发生率(67.2% 对 64.6%;P=0.85)或心肌内出血发生率(55.7% 对 60%;P=0.72)方面,PiCSO 治疗患者和对照组患者之间未发现差异。赞助商提前终止了这项研究,6 个月后不再进行临床随访。结论:在这项提前终止的随机试验中,与传统的 pPCI 相比,PiCSO 作为 pPCI 的辅助治疗并不能减少前 ST 段抬高型心肌梗死患者的 IS。使用 PiCSO 会增加手术时间和造影剂用量,但 6 个月内的不良事件并未增加:NCT03625869。
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Circulation: Cardiovascular Interventions
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