American Journal of Cardiology最新文献

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Performance and Failure of Right Ventricle to Pulmonary Artery Conduit in Congenital Heart Disease 先天性心脏病中右心室至肺动脉导管的性能和失败。
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-08 DOI: 10.1016/j.amjcard.2024.06.026
{"title":"Performance and Failure of Right Ventricle to Pulmonary Artery Conduit in Congenital Heart Disease","authors":"","doi":"10.1016/j.amjcard.2024.06.026","DOIUrl":"10.1016/j.amjcard.2024.06.026","url":null,"abstract":"<div><p>Surgical implantation of a right ventricle to pulmonary artery (RV-PA) conduit is an important component of congenital heart disease (CHD) surgery, but with limited durability, leading to re-intervention. The present single-center, retrospective, cohort study reports the results of surgically implanted RV-PA conduits in a consecutive series of children and adults with CHD. Patients with CHD referred for RV-PA conduit surgical implantation (from October 1997 to January 2022) were included. The primary outcome was conduit failure, defined as a peak gradient above 64 mm Hg, severe regurgitation, or the need for conduit-related interventions. Longitudinal echocardiographic studies were available for mixed-effects linear regression analysis. A total of 252 patients were initially included; 149 patients were eligible for follow-up data collection. After a median follow-up time of 49 months, the primary study end point occurred in 44 (29%) patients. A multivariable Cox regression model identified adult age (&gt;18 years) at implantation and pulmonary homograft implantation as protective factors (hazard ratio 0.11, 95% confidence interval [CI] 0.02 to 0.47 and hazard ratio 0.34, 95% CI 0.16 to 0.74, respectively). Fever within 7 days of surgical conduit implantation was a risk factor for early (within 24 months) failure (odds ratio 4.29, 95% CI 1.41 to 13.01). Long-term use of oral anticoagulants was independently associated with slower progression of peak echocardiographic gradient across the conduits (mixed-effects linear regression p = 0.027). In patients with CHD, the rate of failure of surgically implanted RV-PA conduits is higher in children and after nonhomograft conduit implantation. Early fever after surgery is a strong risk factor for early failure. Long-term anticoagulation seems to exert a protective effect.</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141578677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Comparison of Drug-Coated Balloons With Drug-Eluting Stents in Patients With In-Stent Restenosis: A Systematic Review and Meta-Analysis 支架内再狭窄患者使用药物涂层球囊与药物洗脱支架的比较:系统回顾与元分析》。
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-08 DOI: 10.1016/j.amjcard.2024.06.028
{"title":"Comparison of Drug-Coated Balloons With Drug-Eluting Stents in Patients With In-Stent Restenosis: A Systematic Review and Meta-Analysis","authors":"","doi":"10.1016/j.amjcard.2024.06.028","DOIUrl":"10.1016/j.amjcard.2024.06.028","url":null,"abstract":"<div><p>In-stent restenosis (ISR) is the gradual narrowing of the stented coronary segment, presenting as angina or leading to an acute myocardial infarction. Although its incidence has decreased with the use of newer drug-eluting stents (DES), it still carries significant mortality and morbidity risks. We compared the 2 most common interventions for managing DES-related ISR: drug-coated balloons (DCBs) and DES. Electronic databases were searched to identify all randomized controlled trials comparing DCB with DES in patients with DES-ISR. The Mantel–Haenszel method with a random-effects model was used to calculate pooled risk ratios. Five trials comprising 1,100 patients (577 in DCB and 523 in DES group) were included in the final study. The mean follow-up was 42 months. DCB was found to have a higher risk for target lesion revascularization (risk ratio 1.41, p = 0.02) compared with DES. No difference was observed in all-cause mortality, target vessel revascularization, myocardial infarction, or stroke between the 2 intervention arms. In conclusion, management of DES-ISR with DCB has a higher risk of target lesion revascularization compared with re-stenting with DES. The 2 therapeutic interventions are comparable in terms of efficacy and safety profile.</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141578676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Symptomatic Heart Failure and Clonal Hematopoiesis–Related Mutations in Patients With Acute Myeloid Leukemia 急性髓性白血病患者的症状性心力衰竭与克隆性造血相关突变
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-06 DOI: 10.1016/j.amjcard.2024.06.033
{"title":"Symptomatic Heart Failure and Clonal Hematopoiesis–Related Mutations in Patients With Acute Myeloid Leukemia","authors":"","doi":"10.1016/j.amjcard.2024.06.033","DOIUrl":"10.1016/j.amjcard.2024.06.033","url":null,"abstract":"<div><p>Clonal hematopoiesis of indeterminate potential (CHIP) is a common risk factor for hematologic malignancies and cardiovascular diseases. This study aimed to investigate the association between CHIP-related mutations and symptomatic heart failure (HF) in patients diagnosed with acute myeloid leukemia (AML). A total of 563 patients with newly diagnosed AML who underwent DNA sequencing of bone marrow before treatment were retrospectively investigated. Cox proportional hazard regression models and Fine and Gray's subdistribution hazard regression models were used to assess the association between CHIP-related mutations and symptomatic HF. A total of 79.0% patients had at least 1 CHIP-related mutation; the most frequent mutations were DNMT3A, ASXL1, and TET2. A total of 51 patients (9.1%) developed symptomatic HF. The incidence of symptomatic HF was more frequent in patients with DNMT3A mutations (p &lt;0.01), with a 1-year cumulative incidence of symptomatic HF in patients with DNMT3A mutations of 11.4%, compared with 3.9% in patients with wild-type DNMT3A (p &lt;0.01). After adjustment for age and anthracyclines dose, DNMT3A mutations remained independently correlated with HF (hazard ratio 2.32, 95% confidence interval 1.26 to 4.29, p = 0.01). In conclusion, in patients with AML, the presence of DNMT3A mutations was associated with a twofold increased risk for symptomatic HF, irrespective of age and anthracyclines use.</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial 急性冠状动脉综合征患者PCI术后使用非减量肝素抗凝:STOPDAPT-3试验的启示。
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-06 DOI: 10.1016/j.amjcard.2024.07.002
{"title":"Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial","authors":"","doi":"10.1016/j.amjcard.2024.07.002","DOIUrl":"10.1016/j.amjcard.2024.07.002","url":null,"abstract":"<div><p>The current guidelines for acute coronary syndrome (ACS) discourage the use of anticoagulation after percutaneous coronary intervention (PCI) without specific indications, although the recommendation is not well supported by evidence. In this post hoc analysis of the ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 (STOPDAPT-3) trial, 30-day outcomes were compared between the 2 groups with and without post-PCI heparin administration among patients with ACS who did not receive mechanical support devices. The co-primary end points were the bleeding end point, defined as the Bleeding Academic Research Consortium type 3 or 5 bleeding, and the cardiovascular end point, defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. Among 4,088 patients with ACS, 2,339 patients (57.2%) received post-PCI heparin. The proportion of patients receiving post-PCI heparin was higher among those with ST-elevation myocardial infarction compared with others (72.3% and 38.8%, p &lt;0.001), and among patients with intraprocedural adverse angiographic findings compared with those without (67.6% and 47.5%, p &lt;0.001). Post-PCI heparin compared with no post-PCI heparin was associated with a significantly increased risk of the bleeding end point (4.75% and 2.52%, adjusted hazard ratio 1.69, 95% confidence interval 1.15 to 2.46, p = 0.007) and a numerically increased risk of the cardiovascular end point (3.16% and 1.72%, adjusted hazard ratio 1.56, 95% confidence interval 0.98 to 2.46, p = 0.06). Higher hourly dose or total doses of heparin were also associated with higher incidence of both bleeding and cardiovascular events within 30 days. In conclusion, post-PCI anticoagulation with unfractionated heparin was frequently implemented in patients with ACS. Post-PCI heparin use was associated with harm in terms of increased bleeding without the benefit of reducing cardiovascular events. Trial identifier: STOPDAPT-3 ClinicalTrials.gov number, NCT04609111</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Three-Year Left Ventricular Assist Device Outcomes and Strategy After Heart Transplant Allocation Score Change 心脏移植后左心室辅助装置的 3 年疗效和策略分配评分变化。
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-06 DOI: 10.1016/j.amjcard.2024.07.001
{"title":"Three-Year Left Ventricular Assist Device Outcomes and Strategy After Heart Transplant Allocation Score Change","authors":"","doi":"10.1016/j.amjcard.2024.07.001","DOIUrl":"10.1016/j.amjcard.2024.07.001","url":null,"abstract":"<div><p>The United Network for Organ Sharing (UNOS) adopted new criteria for the heart allocation score on October 18, 2018 to reflect the changing trends of candidates’ mortality while awaiting transplant. We examined the impact of these policy changes on rates of left ventricular assist device (LVAD) implantation and outcomes after transplant from a relatively newer UNOS database. The UNOS registry was used to identify first-time adult heart recipients with LVAD at listing or transplant who underwent transplantation between January 1, 2016 and March 10, 2020. Survival data were collected through March 30, 2023. Those listed before October 18, 2018 but transplanted after were excluded. Patients were divided into before or after change groups. Demographics and clinical parameters were compared. Survival was analyzed with Kaplan–Meier curves and log-rank tests. A p &lt;0.05 was considered significant. We identified 4,387 heart recipients with LVAD in the before (n = 3,606) and after (n = 781) score change eras. The after group had a lower rate of LVAD implantation while listed than the before group (20.4% vs 34.9%, p &lt;0.0001), and were more likely to be female (25.1% vs 20.2%, p = 0.002); in both groups, most recipients (62.8%) were white. There was significantly farther distance from the donor hospital to transplant center in the after group (264.4 NM vs 144.2 NM, p &lt;0.0001) and decreased waitlist days (84.9 ± 105.1 vs 369.2 ± 459.5, p &lt;0.0001). Recipients in the after group were more likely to use extracorporeal membrane oxygenation (3.7% vs 0.5%, p &lt;0.0001) and intravenous inotropes (19.1% vs 7.5%, p &lt;0.0001) and receive a Centers for Disease Control and Prevention increased risk donor organ (37.9% vs 30.5%, p &lt;0.0001). Survival at 3 years was comparable between the 2 groups.</p><p>The allocation score change in 2018 yielded considerable changes in mechanical circulatory support device implantation strategy and outcomes. The rate of LVAD implantation decreased with increased utilization of temporary mechanical circulatory support devices.</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Real-Time Intravascular Ultrasound Guidance Versus Angiographic Guidance for Precise Left Anterior Descending Artery Ostial Stenting 实时血管内超声引导与血管造影引导在精确左前降支动脉支架置入术中的对比。
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-05 DOI: 10.1016/j.amjcard.2024.06.032
{"title":"Real-Time Intravascular Ultrasound Guidance Versus Angiographic Guidance for Precise Left Anterior Descending Artery Ostial Stenting","authors":"","doi":"10.1016/j.amjcard.2024.06.032","DOIUrl":"10.1016/j.amjcard.2024.06.032","url":null,"abstract":"","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome: A Double-Blind, Randomized, Sham-Controlled Trial 永久性乳内动脉闭塞对慢性冠状动脉综合征的临床疗效:一项双盲、随机、假对照试验。
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-03 DOI: 10.1016/j.amjcard.2024.06.030
Marius Reto Bigler MD, PhD , Andrea Kieninger-Gräfitsch MD , Christine Tschannen RN, Raphael Grossenbacher RN, Christian Seiler MD
{"title":"Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome: A Double-Blind, Randomized, Sham-Controlled Trial","authors":"Marius Reto Bigler MD, PhD ,&nbsp;Andrea Kieninger-Gräfitsch MD ,&nbsp;Christine Tschannen RN,&nbsp;Raphael Grossenbacher RN,&nbsp;Christian Seiler MD","doi":"10.1016/j.amjcard.2024.06.030","DOIUrl":"10.1016/j.amjcard.2024.06.030","url":null,"abstract":"<div><p>The Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Chronic Coronary Syndrome (CLIMACCS) trial, a randomized, sham-controlled trial, tested the clinical efficacy of permanent internal mammary artery (IMA) device occlusion on symptoms in patients with chronic coronary syndrome (CCS), coronary artery occlusive blood supply, and myocardial ischemia. This was a prospective trial in 101 patients with CCS randomly allocated (1:1) to IMA device occlusion (verum group) or to IMA sham intervention (placebo group). The primary study end point was the change in treadmill exercise time (ET) (ΔET in seconds) at 6 weeks after trial intervention. Secondary study end points were the changes in collateral flow index (CFI) and angina pectoris during a simultaneous 1-minute proximal balloon occlusion of a coronary artery. CFI is the ratio between simultaneous mean coronary occlusive, divided by mean aortic pressure, both subtracted by central venous pressure. In the verum and placebo groups, the ET changed from 398 ± 176 seconds to 421 ± 198s in the verum group (p = 0.1745) and from 426 ± 162 seconds to 430 ± 166 seconds in the placebo group (p = 0.55); ΔET amounted to +23 ± 116s and +4 ± 120 seconds, respectively (p = 0.44). CFI change during follow-up equaled +0.022 ± 0.061 in the verum and −0.039 ± 0.072 in the placebo group (p &lt;0.0001). Angina pectoris at follow-up during the coronary balloon occlusion for CFI measurement had decreased or disappeared in 20 of 48 patients in the verum group and in 9 of 47 patients in the placebo group (p = 0.0242). In conclusion, permanent IMA device occlusion tends to augment treadmill ET in response to increased coronary artery occlusive blood supply, which is reflected by mitigated symptoms and signs of myocardial ischemia.</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002914924004673/pdfft?md5=457757363c9410015f78c1cde0aed3b4&pid=1-s2.0-S0002914924004673-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141537437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of Direct Oral Anticoagulants in Patients With Peripheral Artery Disease: A Meta-Analysis 外周动脉疾病患者使用直接口服抗凝剂:一项 Meta 分析。
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-03 DOI: 10.1016/j.amjcard.2024.06.031
{"title":"Use of Direct Oral Anticoagulants in Patients With Peripheral Artery Disease: A Meta-Analysis","authors":"","doi":"10.1016/j.amjcard.2024.06.031","DOIUrl":"10.1016/j.amjcard.2024.06.031","url":null,"abstract":"","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141537438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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 Factors, Use of Revascularization, and Outcomes in Young Adults With ST-Elevation Myocardial Infarction 年轻成人 STEMI 患者的风险因素、血管再通的使用和预后。
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-07-02 DOI: 10.1016/j.amjcard.2024.06.029
Sara J. King MD , Rajiv Patel MD , Sameer Arora MD , George A. Stouffer MD
{"title":"Risk Factors, Use of Revascularization, and Outcomes in Young Adults With ST-Elevation Myocardial Infarction","authors":"Sara J. King MD ,&nbsp;Rajiv Patel MD ,&nbsp;Sameer Arora MD ,&nbsp;George A. Stouffer MD","doi":"10.1016/j.amjcard.2024.06.029","DOIUrl":"10.1016/j.amjcard.2024.06.029","url":null,"abstract":"<div><p>The incidence of acute myocardial infarction is increasing in younger age groups, with differences in treatment and outcomes based on gender. ST-elevation myocardial infarction (STEMI) in young adults, however, is incompletely understood as most of the current studies were performed in homogenous populations, did not focus on STEMI, and lack direct comparisons with older adults. We performed a retrospective observational study using the Statewide Planning And Research Cooperative System for all admissions in New York State with a principal diagnosis of STEMI from 2011 to 2018. There were 58,083 STEMIs with the majority being male (68.2%) and non-Hispanic White (64.8%), with an average age of 63.9 ± 13.9 years. Of these, 8,494 (14.6%) occurred in patients aged &lt;50 years. The proportion of STEMIs in women increased with age, from 19.2% in the &lt;50-year-old age group to 48.9% in the ≥70-year-old age group. Young adults with STEMI had greater prevalence of obesity, current tobacco use, other substance use, and major psychiatric disorders, were more likely to receive revascularization, and had lower 1-year mortality than older age groups. Revascularization was associated with at least a 3 times lower odds ratio of 1-year mortality in all age groups. In conclusion, young adults with STEMI had a unique set of risk factors and co-morbidities and were more likely to undergo revascularization than older age groups. In all age groups, female gender was associated with a higher burden of co-morbidities, decreased use of revascularization, and increased 1-year mortality.</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141533395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Design and Rationale of the V-Wave Shunt MitraClip Study V 波分流 MitraClip 研究的设计与原理
IF 2.3 3区 医学
American Journal of Cardiology Pub Date : 2024-06-29 DOI: 10.1016/j.amjcard.2024.06.023
{"title":"Design and Rationale of the V-Wave Shunt MitraClip Study","authors":"","doi":"10.1016/j.amjcard.2024.06.023","DOIUrl":"10.1016/j.amjcard.2024.06.023","url":null,"abstract":"<div><p>Heart failure (HF) and moderate-to-severe mitral regurgitation (MR) with residual elevations in left atrial pressure (LAP) after MitraClip may remain symptomatic and experience subsequent HF readmissions. The V-Wave interatrial shunt system is a permanent interatrial septal implant that shunts blood from the left-to-right atrium and serves to continuously unload the left atrium. Although the V-Wave shunt has previously been studied in patients with HF, the safety and feasibility of its deployment at the time of the MitraClip procedure is unknown.</p><p>The V-Wave Shunt MitraClip Study (NCT04729933) is an early feasibility study that aims to demonstrate the safety and efficacy of implantation of the V-Wave shunt device at the time of MitraClip procedure. Patients with moderate-to-severe secondary MR with left ventricular ejection fraction 20% to 50% and New York Heart Association functional class III/IV symptoms despite optimal medical therapy, residual mean LAP ≥20 mm Hg after MitraClip, and mean LAP–right atrial pressure difference ≥5 mm Hg are included. The primary safety end point is a composite outcome of all-cause death, stroke, myocardial infarction device embolization, cardiac tamponade, or device-related re-intervention or surgery at 30 days. Patients will be followed up to 5 years. Enrollment is ongoing, with 30-day results expected by the end of 2024.</p><p>The V-Wave Shunt Mitraclip Study aims to demonstrate the safety and efficacy of the implantation of the V-Wave interatrial shunt device at the time of index MitraClip placement which may serve as an adjunctive method by which continuous left atrial unloading may be achieved.</p></div>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141475702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
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