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Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study 公平地改变钙化冠状动脉疾病女性患者的斑块:EMPOWER CAD 研究的设计与原理
Pub Date : 2024-11-01 DOI: 10.1016/j.jscai.2024.102289
Margaret McEntegart MD , Nieves Gonzalo MD , Lahn Fendelander MS , Nick E.J. West MD , Alexandra J. Lansky MD

Background

Coronary artery disease (CAD) is the leading cause of death for women, yet they remain underrepresented in interventional CAD studies. Women have been shown to be at increased risk of mortality and major adverse events after percutaneous coronary intervention (PCI). The poorer outcomes are likely because women are typically diagnosed with CAD late, at an older age, with more comorbidities, and with more challenging anatomy including smaller vessels and higher prevalence of coronary artery calcification.

Methods

The EMPOWER CAD study (NCT05755711) is a postmarket, prospective, multicenter, single-arm observational study of the Shockwave Coronary intravascular lithotripsy (IVL) system for the treatment of women with calcified coronary artery disease. The study will enroll 400 female patients referred for PCI with coronary IVL and stenting. The primary safety end point is target lesion failure (TLF) at 30 days, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The primary effectiveness end point is procedural success, defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions and without in-hospital TLF as assessed by an independent core laboratory and clinical events committee. Patients will be followed up for 3 years.

Conclusions

The EMPOWER CAD study will enroll real-world female patients. Adjunctive use of IVL with other calcium modification technologies will be assessed, as well as a subcohort analysis of patients with optical coherence tomography imaging. The EMPOWER CAD study therefore directly addresses the underrepresentation of women in interventional cardiology clinical trials.
背景冠状动脉疾病(CAD)是导致女性死亡的主要原因,但在介入性冠状动脉疾病研究中,女性的比例仍然偏低。研究表明,经皮冠状动脉介入治疗(PCI)后,女性的死亡率和主要不良事件风险都会增加。较差的预后可能是因为女性被诊断出患有 CAD 的时间通常较晚、年龄较大、合并症较多、解剖结构更具挑战性,包括血管较小、冠状动脉钙化发生率较高。方法 EMPOWER CAD 研究(NCT05755711)是一项关于冲击波冠状动脉血管内碎石术(IVL)系统治疗患有钙化冠状动脉疾病的女性的上市后、前瞻性、多中心、单臂观察研究。该研究将招募 400 名转诊为 PCI 的女性患者,进行冠状动脉 IVL 和支架植入术。主要安全性终点是30天后的靶病变失败(TLF),定义为心源性死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建的综合结果。主要疗效终点是手术成功,定义为支架植入后所有靶病变的支架内残余狭窄≤30%,且经独立核心实验室和临床事件委员会评估无院内TLF。结论EMPOWER CAD研究将招募真实世界中的女性患者。研究将评估 IVL 与其他钙修饰技术的联合使用情况,并对使用光学相干断层扫描成像的患者进行亚队列分析。因此,EMPOWER CAD 研究直接解决了介入心脏病学临床试验中女性代表不足的问题。
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引用次数: 0
The Revolution of STEMI Care: A Story of Resilience, Persistence, and Success STEMI 护理的革命:韧性、坚持和成功的故事
Pub Date : 2024-11-01 DOI: 10.1016/j.jscai.2024.102395
Paul Bamford MBChB , Timothy D. Henry MD , William W. O’Neill MD , Cindy L. Grines MD
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引用次数: 0
Percutaneous Coronary Intervention Versus Robotic Coronary Bypass for Left Anterior Descending Artery Chronic Total Occlusion 经皮冠状动脉介入治疗与机器人冠状动脉搭桥术治疗左前降支动脉慢性全闭塞
Pub Date : 2024-10-01 DOI: 10.1016/j.jscai.2024.102278
Elsa Hebbo MD , Wissam A. Jaber MD , Giancarlo Licitra MD , Bryan Kindya MD , Malika Elhage Hassan MD , Mariem Sawan MD , Nikoloz Shekiladze MD , Pratik B. Sandesara MD , William J. Nicholson MD , Michael E. Halkos MD

Background

Both percutaneous coronary interventions (PCIs) and robotic-assisted coronary artery bypass (CAB) offer viable options for left anterior descending (LAD) chronic total occlusion (CTO) revascularization. Our study aims to compare long-term clinical outcomes associated with these 2 strategies.

Methods

In this retrospective study, we analyzed data from 273 patients diagnosed with LAD CTO who underwent either PCI (n = 129) or CAB (n = 144) at a single institution. Long-term follow-up was available for 96 PCI and 125 CAB patients. We employed Kaplan-Meier curves and the log-rank test to conduct cumulative survival analyses free of major adverse cardiovascular events (MACE), cumulative survival, survival free of myocardial infarction, and repeat revascularization.

Results

In the study cohort, patients who underwent PCI exhibited a higher prevalence of comorbidities including diabetes (48.9% vs 24.6%; P < .001), lower ejection fraction (44 ± 14 vs 52 ± 10; P < .001), prior heart failure (36.6% vs 22.2%; P = .02), and prior bypass surgery (16% vs 0, P < .001). PCI to non-LAD vessels was performed as part of initial complete revascularization in 40.3% of PCI and 40.6% of CAB patients. Upon a median 3.4 years of follow-up, CAB patients had significantly higher rates of survival free of MACE compared to PCI patients (unadjusted hazard ratio, 2.39; 95% CI, 1.13-5.03). Although PCI patients had similar unadjusted mortality, they experienced higher myocardial infarction and repeat revascularizations compared to CAB. However, the risk of repeat revascularization was attenuated after adjusting for prior bypass, diabetes, and ejection fraction.

Conclusions

Among patients with LAD CTO, those undergoing robotic-assisted CAB had a higher 5-year overall survival free of MACE compared to those who underwent PCI. This discrepancy in outcomes can be attributed in part to the greater burden of comorbidities among PCI patients.
背景经皮冠状动脉介入治疗(PCI)和机器人辅助冠状动脉搭桥术(CAB)都为左前降支(LAD)慢性全闭塞(CTO)血运重建提供了可行的选择。在这项回顾性研究中,我们分析了 273 例确诊为 LAD CTO 患者的数据,这些患者在一家医疗机构接受了 PCI(129 例)或 CAB(144 例)。其中 96 名 PCI 患者和 125 名 CAB 患者接受了长期随访。我们采用 Kaplan-Meier 曲线和对数秩检验对无重大不良心血管事件 (MACE)、累积存活率、无心肌梗死存活率和重复血管再通进行了累积存活率分析。结果在研究队列中,接受PCI的患者合并症发生率较高,包括糖尿病(48.9% vs 24.6%;P < .001)、射血分数较低(44 ± 14 vs 52 ± 10;P < .001)、既往心衰(36.6% vs 22.2%;P = .02)和既往搭桥手术(16% vs 0,P < .001)。在40.3%的PCI患者和40.6%的CAB患者中,对非LAD血管进行PCI是最初完全血运重建的一部分。在中位 3.4 年的随访中,与 PCI 患者相比,CAB 患者的无 MACE 生存率明显更高(未经调整的危险比为 2.39;95% CI 为 1.13-5.03)。虽然 PCI 患者的未调整死亡率相似,但与 CAB 相比,PCI 患者的心肌梗死和重复血管重建率更高。结论在 LAD CTO 患者中,与接受 PCI 的患者相比,接受机器人辅助 CAB 的患者 5 年总生存率更高,且无 MACE。这种结果上的差异可部分归因于PCI患者的并发症负担更重。
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引用次数: 0
Percutaneous Repair of Chronic Aortic Pseudoaneurysm: A Single-Center Experience 经皮修复慢性主动脉假性动脉瘤:单中心经验
Pub Date : 2024-10-01 DOI: 10.1016/j.jscai.2024.102249
Bruce E. Lewis MD , Dominick V. Bufalino MD , Mohammed H. Hussein MD , Sorcha Allen MBBCh, BAO , Lukas Burke MD , Rashad J. Belin MD, PhD , Marc G. Henderson RCIS , Jeffrey Schwartz MD

Background

Aortic pseudoaneurysm (AP) is a late complication of aortic repair that, without intervention, carries a high mortality rate. Surgical repair has significant in-hospital mortality and high health care costs. Endovascular stent grafting use is currently limited to branch-free aortic segments or the use of complex fenestrated devices. Our objective was to review the literature and share our institution’s experience with AP percutaneous closure by vascular plugs and occluder technology.

Methods

We retrospectively reviewed percutaneous AP closure cases published in the literature (2005-2016) and from our institution (2017-2019). The follow-up strategy in our institution group was up to the discretion of the performing physician. We measured the procedure’s safety, complications, and follow-up outcomes.

Results

We found 40 cases in the literature and 10 at our institution. The procedural success rate was 90% in the literature and 100% in our group. Our group’s average length of stay was 1.9 days with no observed major procedural complications. The literature’s follow-up was generally limited to the hospitalization period. Our patients had a median follow-up time of 12 months (range 3-47 months). Late follow-up of AP demonstrated that sac size remained stable or reduced in 6 patients, but a size increase was observed in 4 patients requiring surgical intervention. Death from nonprocedure-related complications occurred in 40% of our patients. The cost per procedure was hypothetically less than for performing open surgical repair.

Conclusions

Our experience shows a viable option for percutaneous AP repair, given its initial safety and cost-effectiveness. Our experience highlights the critical role of follow-up imaging in identifying AP expansion and the need for further intervention. The high nonaorta-related mortality seen in follow-up emphasizes the high-risk nature of the population due to comorbidities.
背景主动脉假性动脉瘤(AP)是主动脉修补术的晚期并发症,如不进行干预,死亡率很高。手术修复的院内死亡率很高,医疗费用也很高。目前,血管内支架移植仅限于无分支的主动脉段或使用复杂的栅栏式装置。我们的目的是回顾文献,并分享我院使用血管栓塞和闭塞器技术经皮闭合 AP 的经验。方法我们回顾了文献中发表的经皮闭合 AP 病例(2005-2016 年)和我院的病例(2017-2019 年)。我院组的随访策略由手术医生自行决定。我们对手术的安全性、并发症和随访结果进行了测量。文献中的手术成功率为 90%,我院的手术成功率为 100%。我们小组的平均住院时间为 1.9 天,未发现重大手术并发症。文献中的随访一般仅限于住院期间。本组患者的中位随访时间为 12 个月(3-47 个月)。对 AP 的后期随访显示,有 6 名患者的囊大小保持稳定或缩小,但有 4 名患者的囊大小增大,需要进行手术干预。40%的患者死于与手术无关的并发症。结论:我们的经验表明,鉴于经皮 AP 修复术最初的安全性和成本效益,它是一种可行的选择。我们的经验强调了随访成像在识别 AP 扩大和进一步干预需求方面的关键作用。随访中发现的非主动脉相关死亡率很高,这强调了该人群因合并症而具有的高风险性。
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引用次数: 0
Dr George L. Bakris, 1952-2024 乔治-L-巴克里斯博士,1952-2024 年
Pub Date : 2024-10-01 DOI: 10.1016/j.jscai.2024.102279
Michael H. Davidson MD
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引用次数: 0
Corrigendum to “Intra-cardiac echocardiography-guided percutaneous aspiration of tricuspid vegetations” [JSCAI 3/3PA(2024):101291] 心内超声心动图引导下经皮抽吸三尖瓣植物 "的更正 [JSCAI 3/3PA(2024):101291]
Pub Date : 2024-10-01 DOI: 10.1016/j.jscai.2024.102290
Zach Rozenbaum MD
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引用次数: 0
Maneuvering Through the Uncertainty of Deep Vein Thrombosis Interventions: An Encouraging Contemporary Analysis 穿越深静脉血栓干预的不确定性:令人鼓舞的当代分析
Pub Date : 2024-10-01 DOI: 10.1016/j.jscai.2024.102287
Giorgio A. Medranda MD , Sahil A. Parikh MD , Hady Lichaa MD
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引用次数: 0
The Beneficial Atrial Septal Defect Shunt in Hypertrophic Cardiomyopathy—When Closure Is Not the Answer 肥厚型心肌病中的有益心房间隔缺损分流术--当关闭心房间隔缺损并不能解决问题时
Pub Date : 2024-10-01 DOI: 10.1016/j.jscai.2024.102281
Mohammad Alnoor MD, Ahmed Deniwar MD, Sherzana Sunderji MD
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引用次数: 0
Hemodynamic Assessment and Transcatheter Intervention Treating Pulmonary Vein Stenosis 血液动力学评估和经导管介入治疗肺静脉狭窄
Pub Date : 2024-10-01 DOI: 10.1016/j.jscai.2024.102250
Ashish H. Shah MD, MD-Research (UK), FRCP (UK) , Triston Eastman MD , Petra Jenkins MD, FRCP (UK)
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引用次数: 0
Long-Term Adverse Limb Events After Femoral Artery Endovascular Revascularization: The Boston FAROUT Study 股动脉血管内再通术后的长期肢体不良事件:波士顿 FAROUT 研究
Pub Date : 2024-10-01 DOI: 10.1016/j.jscai.2024.102241
Edwin Mandieka MD , Ramael Ohiomoba MD, MPH , Piotr Sobieszczyk MD , Andrew C. Eisenhauer MD , Thomas Todoran MD , Scott Kinlay MBBS, PhD

Background

: Patient, lesion, and procedural characteristics may impact the long-term risks of adverse limb outcomes differently after successful endovascular revascularization for lower extremity peripheral artery disease. The study objective was to assess the relationships of patient, lesion, and procedural characteristics to the subsequent risk of major and minor adverse limb events over the decade after successful endovascular revascularization of the superficial femoral artery for chronic limb-threatening ischemia (CLTI) or lifestyle-limiting claudication.

Methods

A retrospective cohort of patients who underwent endovascular revascularization between 2003-2011 were followed for a median of 9.3 (IQR, 6.8-11.1) years. Hazard ratios (HR) and 95% CI from Cox proportional hazards models assessed the risk of major adverse limb events (MALE) (major amputation, bypass, or thrombolysis) or minor revascularization, MALE alone, and minor revascularization alone.

Results

There were 232 index limb revascularizations in 185 patients. Longer lesion length was associated with a higher risk of MALE or minor revascularization (HR, 2.09; 95% CI, 1.22-3.60) and minor revascularization alone (HR, 2.53; 95% CI, 1.39-4.61). Current smoking was linked with minor revascularization (HR, 3.83; 95% CI, 1.54-9.56). CLTI was associated with MALE or minor revascularization (HR, 1.89; 95% CI, 1.09-3.29), and MALE alone (HR, 7.43; 95% CI, 3.11-17.79). Black race/ethnicity (HR, 4.74; 95% CI, 1.51-14.9) and low-density lipoprotein >100 mg/dL (HR, 2.76; 95% CI, 1.20-6.35) were linked to MALE alone.

Conclusions

Factors related to MALE differed from those related to minor revascularization. Lesion length and smoking were linked to minor revascularization, whereas CLTI, Black race/ethnicity, and elevated low-density lipoprotein were linked to MALE.
背景:成功进行下肢外周动脉血管再通术后,患者、病变和手术特征可能会对肢体不良后果的长期风险产生不同的影响。该研究的目的是评估患者、病变和手术特征与因慢性肢体威胁性缺血(CLTI)或生活方式限制性跛行而成功接受股浅动脉血管内再通术后十年内发生主要和次要肢体不良事件的风险之间的关系。方法:对2003-2011年间接受血管内再通术的患者进行回顾性队列随访,随访时间中位数为9.3年(IQR,6.8-11.1年)。Cox比例危险模型得出的危险比(HR)和95% CI评估了肢体重大不良事件(MALE)(重大截肢、搭桥或溶栓)或轻微血管再通、单纯MALE和单纯轻微血管再通的风险。病变长度越长,接受MALE或小血管再通手术(HR,2.09;95% CI,1.22-3.60)和单纯小血管再通手术(HR,2.53;95% CI,1.39-4.61)的风险越高。目前吸烟与轻微血管再通术有关(HR,3.83;95% CI,1.54-9.56)。CLTI与男性或轻微血管再通有关(HR,1.89;95% CI,1.09-3.29),也与仅男性有关(HR,7.43;95% CI,3.11-17.79)。黑人种族/民族(HR,4.74;95% CI,1.51-14.9)和低密度脂蛋白100 mg/dL(HR,2.76;95% CI,1.20-6.35)与单纯MALE相关。病变长度和吸烟与轻微血管再通有关,而CLTI、黑人种族/族裔和低密度脂蛋白升高与MALE有关。
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引用次数: 0
期刊
Journal of the Society for Cardiovascular Angiography & Interventions
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