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Abbreviated or standard antiplatelet therapy after PCI in HBR patients with chronic kidney disease: a prespecified analysis from the MASTER DAPT trial. 慢性肾脏疾病HBR患者PCI术后简化或标准抗血小板治疗:MASTER DAPT试验的预先指定分析
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-01 DOI: 10.4244/EIJ-D-25-00566
Antonio Landi, Felix Mahfoud, Enrico Frigoli, Konstantina Chalkou, Dik Heg, Rajpal K Abhaichand, Atul Damodar Abhyankar, Emanuele Barbato, Farzin Beygui, Peter W Danse, Ali Garachemani, Bruno García Del Blanco, Kurt Huber, René Koning, Neville Kukreja, Christophe Piot, Nguyen Ngoc Quang, Ashok Tirouvanziam, Mathieu Valla, Pieter C Smits, Marco Valgimigli, On Behalf Of The Master Dapt Investigators

Background: Abbreviated antiplatelet therapy (APT) can reduce bleeding without increasing ischaemic harm in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI). The impact of chronic kidney disease (CKD) on the safety and effectiveness of abbreviated APT remains unknown.

Aims: We aimed to investigate the comparative effectiveness of abbreviated (1 month) versus standard (≥3 months) APT in HBR patients with and without CKD.

Methods: This was a prespecified analysis from the MASTER DAPT trial, which randomised 4,579 HBR patients (1,428 [31%] with CKD) to abbreviated or standard APT. CKD was defined as an estimated glomerular filtration rate <60 mL/min/1.73 m2. Co-primary outcomes were net adverse clinical events (NACE; a composite of all-cause death, myocardial infarction [MI], stroke, and major bleeding), major adverse cardiac or cerebral events (MACCE; all-cause death, MI and stroke), and Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding at 11 months.

Results: NACE did not significantly differ with abbreviated and standard APT among CKD patients (hazard ratio [HR] 0.91, 95% confidence interval [CI]: 0.66-1.24) and non-CKD patients (HR 0.96, 95% CI: 0.73-1.27; pinteraction=0.78). Similarly, MACCE did not differ in CKD patients (HR 0.91, 95% CI: 0.64-1.27) and non-CKD patients (HR 1.09, 95% CI: 0.78-1.51; pinteraction=0.45). Abbreviated APT was associated with consistently lower BARC 2, 3, or 5 bleeding in both patients with CKD (HR 0.74, 95% CI: 0.52-1.07) and without it (HR 0.66, 95% CI: 0.51-0.85; pinteraction=0.59).

Conclusions: Abbreviated APT was associated with similar NACE and MACCE rates and reduced bleeding compared with standard APT in HBR patients undergoing PCI, regardless of the presence or absence of CKD. (ClinicalTrials.gov: NCT03023020).

背景:在接受经皮冠状动脉介入治疗(PCI)的高危出血(HBR)患者中,缩短抗血小板治疗(APT)可减少出血而不增加缺血损害。慢性肾脏疾病(CKD)对缩短APT安全性和有效性的影响尚不清楚。目的:我们的目的是研究缩短(1个月)与标准(≥3个月)APT在伴有和不伴有CKD的HBR患者中的比较效果。方法:这是一项来自MASTER DAPT试验的预先指定分析,该试验将4,579名HBR患者(1,428名[31%]患有CKD)随机分配到缩短或标准APT。CKD被定义为肾小球滤过率2。共同主要结局是净不良临床事件(NACE;全因死亡、心肌梗死[MI]、中风和大出血的组合)、主要心脏或大脑不良事件(MACCE;全因死亡、心肌梗死和中风)和出血学术研究联盟(BARC)在11个月时的2、3或5次出血。结果:在CKD患者(风险比[HR] 0.91, 95%可信区间[CI]: 0.66-1.24)和非CKD患者(风险比[HR] 0.96, 95% CI: 0.73-1.27;相互作用=0.78)中,缩短和标准APT的NACE无显著差异。同样,MACCE在CKD患者(HR 0.91, 95% CI: 0.64-1.27)和非CKD患者(HR 1.09, 95% CI: 0.78-1.51; p相互作用=0.45)中也没有差异。在CKD患者和无CKD患者中,APT缩短与BARC 2、3或5出血持续降低相关(HR 0.74, 95% CI: 0.52-1.07) (HR 0.66, 95% CI: 0.51-0.85; p相互作用=0.59)。结论:在接受PCI的HBR患者中,无论是否存在CKD,与标准APT相比,缩短APT与相似的NACE和MACCE发生率以及出血减少相关。(ClinicalTrials.gov: NCT03023020)。
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引用次数: 0
Beta blockers after MI: safe for the few, still relevant for the many. 心肌梗塞后的受体阻滞剂:对少数人安全,但对大多数人仍有意义。
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-01 DOI: 10.4244/EIJ-E-25-00050
Johanne Silvain, Niki Procopi
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引用次数: 0
Reducer migration and coronary sinus thrombosis. 减速器移位和冠状窦血栓形成。
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-01 DOI: 10.4244/EIJ-D-25-00791
Leonardo Portolan, Rafail A Kotronias, Jeremy P Langrish, Giovanni Luigi De Maria
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引用次数: 0
Do we still need more data to adopt a short duration of DAPT routinely following PCI in high bleeding risk patients? 我们是否还需要更多的数据来支持高风险患者PCI术后短时间DAPT的常规应用?
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-01 DOI: 10.4244/EIJ-E-25-00049
Guillaume Marquis-Gravel, Renato D Lopes
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引用次数: 0
Identification and treatment of calcified nodules in percutaneous coronary intervention. 经皮冠状动脉介入治疗中钙化结节的识别与治疗。
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-01 DOI: 10.4244/EIJ-D-25-00296
Ziad A Ali, James C Spratt, Aloke V Finn, Akiko Maehara, Doosup Shin

Calcified nodules (CNs) represent significant challenges in percutaneous coronary intervention (PCI) due to their complex morphology, variable treatment responses, and association with stent failure due to reprotrusion or stent underexpansion. CNs are classified into eruptive and non-eruptive subtypes, each with distinct histological features and prognostic implications. Eruptive CNs are biologically active, being associated with a disrupted fibrous cap, overlying thrombus, and intraplaque haemorrhage, and they are thus more readily deformable by balloon dilation during PCI. Non-eruptive CNs, or nodular calcifications, tend to be stable, with an intact fibrous cap, and their deformability varies depending on the composition and base of the nodules. Enhanced angiography and intravascular imaging have greatly improved our understanding of CNs and may help to accurately identify nodule subtypes and guide treatment. Furthermore, understanding the deformability of CNs is crucial for optimising treatment outcomes. In this review, we discuss the identification and management of CNs in the context of PCI.

钙化结节(CNs)由于其复杂的形态、多变的治疗反应以及与支架再膨出或支架扩张不足引起的支架失效相关,在经皮冠状动脉介入治疗(PCI)中提出了重大挑战。中枢神经网络分为爆发型和非爆发型,每一种都有不同的组织学特征和预后意义。爆发性中枢神经网络具有生物活性,与纤维帽断裂、覆盖血栓和斑块内出血有关,因此在PCI期间球囊扩张更容易使其变形。非爆发性中枢神经网络,或结节状钙化,往往是稳定的,具有完整的纤维帽,其变形能力取决于结节的组成和基础。增强的血管造影和血管内成像大大提高了我们对中枢神经系统的认识,并可能有助于准确识别结节亚型和指导治疗。此外,了解神经网络的可变形性对于优化治疗效果至关重要。在这篇综述中,我们讨论了PCI背景下中枢神经网络的识别和管理。
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引用次数: 0
Diagnosis, risk stratification, and early management of non-ST-segment elevation acute coronary syndrome. 非st段抬高急性冠状动脉综合征的诊断、危险分层和早期处理。
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-01 DOI: 10.4244/EIJ-D-25-00100
Mila Kovacevic, Daniel A Jones, Holger Thiele, P Gabriel Steg, Vijay Kunadian

Non-ST-segment elevation acute coronary syndrome (NSTE-ACS) represents a unique clinical syndrome, comprising non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina. NSTEMI, as the more common and serious form of NSTE-ACS, is particularly noteworthy because of its diverse clinical presentation, electrocardiogram changes, and angiography findings, which may pose challenges in diagnosis and treatment and may subsequently influence prognosis. This review offers a comprehensive overview of current evidence-based approaches to NSTE-ACS management, focusing on diagnosis, risk stratification, and treatment strategies while highlighting emerging trends and ongoing challenges in optimising patient outcomes.

非st段抬高型急性冠脉综合征(NSTE-ACS)是一种独特的临床综合征,包括非st段抬高型心肌梗死(NSTEMI)和不稳定型心绞痛。NSTEMI作为NSTE-ACS中较为常见和严重的一种,由于其临床表现、心电图变化和血管造影表现的多样性,尤其值得注意,这可能给诊断和治疗带来挑战,并可能影响预后。本综述全面概述了目前NSTE-ACS管理的循证方法,重点是诊断、风险分层和治疗策略,同时强调了优化患者预后的新趋势和持续挑战。
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引用次数: 0
Thirty-day outcomes of a novel biomimetic balloon-expandable transcatheter heart valve in patients with small aortic annuli. 新型仿生球囊可扩张经导管心脏瓣膜在小主动脉环患者中的30天疗效。
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-16 DOI: 10.4244/EIJ-D-25-01106
Ole De Backer, Arif A Khokhar, Gintautas Bieliauskas, Azeem Latib, Rishi Puri, Tamaz Shaburishvili, Maia Zhividze, Teona Zirakashvili, Anita Asgar, Amar Krishnaswamy, Santiago A Garcia, Rebecca T Hahn, Paul D Mahoney, Thomas Waggoner, Gorav Ailawadi, Stanley Chetcuti, Won-Keun Kim, Joao Cavalcante, Kari Feldt, Jeffrey J Popma, Augustin Coisne, David Meier, Christopher U Meduri, Stephan Windecker, Michael J Reardon, Vinayak N Bapat

Background: Transcatheter aortic valve implantation (TAVI) in patients with small aortic annuli (SAA) is associated with an increased risk of prosthesis-patient mismatch (PPM).

Aims: This study assesses the 30-day performance of the novel, balloon-expandable DurAVR transcatheter heart valve (THV), which features a unique single-piece biomimetic leaflet design, in patients with SAA.

Methods: This pooled analysis derived from first-in-human and early feasibility studies includes all patients with SAA (defined as an aortic annular area from 346 to 452 mm2) treated with the Small size DurAVR THV. The mean computed tomography (CT)-derived aortic annulus area was 404 ± 37 mm², with an average diameter of 22.7 ± 1.0 mm. Outcomes at 30 days, including PPM, were evaluated per Valve Academic Research Consortium-3 (VARC-3) criteria, with independent adjudication of clinical events and core laboratory analysis of post-implant transthoracic echocardiograms.

Results: Amongst 100 patients (mean age 77.0 ± 7.3 years; 78% female; mean Society of Thoracic Surgeons [STS] score 4.7 ± 4.0%) treated with the DurAVR THV, the overall technical success rate was 93%. At 30 days, device success was achieved in 91% of patients, with no reported deaths and a stroke rate of 2%. Echocardiographic haemodynamic assessment showed a mean transprosthetic gradient of 8.2 ± 3.1 mmHg, a mean effective orifice area of 2.2 ± 0.3 cm², and a doppler velocity index of 0.60 ± 0.10. The incidence of moderate or greater PPM was 3%, and no patients experienced more than mild paravalvular leak. The rate of new permanent pacemaker implantation was 6%.

Conclusions: In patients with SAA, the DurAVR THV demonstrated promising clinical and echocardiographic outcomes at 30 days. Longer-term follow-up in larger cohorts is needed to confirm these encouraging early results.

背景:小主动脉环(SAA)患者的经导管主动脉瓣植入术(TAVI)与假体-患者不匹配(PPM)的风险增加相关。目的:本研究评估了新型球囊可膨胀DurAVR经导管心脏瓣膜(THV)在SAA患者中的30天表现,该瓣膜具有独特的单片仿生叶设计。方法:该汇总分析来源于首次人体试验和早期可行性研究,包括所有接受小尺寸DurAVR THV治疗的SAA(定义为主动脉环面积从346至452mm2)患者。CT示主动脉环平均面积为404±37 mm²,平均直径为22.7±1.0 mm。根据瓣膜学术研究联盟-3 (VARC-3)标准评估30天的结果,包括PPM,并对临床事件和植入后经胸超声心动图的核心实验室分析进行独立裁决。结果:100例患者(平均年龄77.0±7.3岁,女性78%,胸外科学会(STS)平均评分4.7±4.0%)采用DurAVR THV治疗,总体技术成功率为93%。在第30天,91%的患者成功植入器械,无死亡报告,卒中率为2%。超声心动图血流动力学评估显示,经假体平均梯度为8.2±3.1 mmHg,平均有效孔口面积为2.2±0.3 cm²,多普勒速度指数为0.60±0.10。中度或更高PPM的发生率为3%,没有患者出现轻度以上的瓣旁漏。新的永久性起搏器植入率为6%。结论:在SAA患者中,DurAVR THV在30天表现出良好的临床和超声心动图结果。需要在更大的队列中进行长期随访,以证实这些令人鼓舞的早期结果。
{"title":"Thirty-day outcomes of a novel biomimetic balloon-expandable transcatheter heart valve in patients with small aortic annuli.","authors":"Ole De Backer, Arif A Khokhar, Gintautas Bieliauskas, Azeem Latib, Rishi Puri, Tamaz Shaburishvili, Maia Zhividze, Teona Zirakashvili, Anita Asgar, Amar Krishnaswamy, Santiago A Garcia, Rebecca T Hahn, Paul D Mahoney, Thomas Waggoner, Gorav Ailawadi, Stanley Chetcuti, Won-Keun Kim, Joao Cavalcante, Kari Feldt, Jeffrey J Popma, Augustin Coisne, David Meier, Christopher U Meduri, Stephan Windecker, Michael J Reardon, Vinayak N Bapat","doi":"10.4244/EIJ-D-25-01106","DOIUrl":"10.4244/EIJ-D-25-01106","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic valve implantation (TAVI) in patients with small aortic annuli (SAA) is associated with an increased risk of prosthesis-patient mismatch (PPM).</p><p><strong>Aims: </strong>This study assesses the 30-day performance of the novel, balloon-expandable DurAVR transcatheter heart valve (THV), which features a unique single-piece biomimetic leaflet design, in patients with SAA.</p><p><strong>Methods: </strong>This pooled analysis derived from first-in-human and early feasibility studies includes all patients with SAA (defined as an aortic annular area from 346 to 452 mm2) treated with the Small size DurAVR THV. The mean computed tomography (CT)-derived aortic annulus area was 404 ± 37 mm², with an average diameter of 22.7 ± 1.0 mm. Outcomes at 30 days, including PPM, were evaluated per Valve Academic Research Consortium-3 (VARC-3) criteria, with independent adjudication of clinical events and core laboratory analysis of post-implant transthoracic echocardiograms.</p><p><strong>Results: </strong>Amongst 100 patients (mean age 77.0 ± 7.3 years; 78% female; mean Society of Thoracic Surgeons [STS] score 4.7 ± 4.0%) treated with the DurAVR THV, the overall technical success rate was 93%. At 30 days, device success was achieved in 91% of patients, with no reported deaths and a stroke rate of 2%. Echocardiographic haemodynamic assessment showed a mean transprosthetic gradient of 8.2 ± 3.1 mmHg, a mean effective orifice area of 2.2 ± 0.3 cm², and a doppler velocity index of 0.60 ± 0.10. The incidence of moderate or greater PPM was 3%, and no patients experienced more than mild paravalvular leak. The rate of new permanent pacemaker implantation was 6%.</p><p><strong>Conclusions: </strong>In patients with SAA, the DurAVR THV demonstrated promising clinical and echocardiographic outcomes at 30 days. Longer-term follow-up in larger cohorts is needed to confirm these encouraging early results.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":""},"PeriodicalIF":9.5,"publicationDate":"2025-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145543986","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
Five-Year Outcomes of the Early-Generation Intrepid Transapical Transcatheter Mitral Valve Replacement System. 早期Intrepid经根尖经导管二尖瓣置换术的5年疗效。
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-16 DOI: 10.4244/EIJ-D-25-01133
Gilbert H L Tang, Vivek Rajagopal, Paul Sorajja, Tanvir Bajwa, Robert Gooley, Antony Walton, Thomas Modine, Martin K Ng, Mathew R Williams, Alan Zajarias, David Hildick-Smith, Didier Tchétché, Konstantinos Spargias, Ronak Rajani, Vinayak N Bapat, Ole De Backer, Daniel Blackman, Patrick McCarthy, Mika Laine, Renuka Jain, Randolph Martin, Jeremy J Thaden, Nicholas A Marka, Michael Mack, David H Adams, Martin B Leon, Michael J Reardon

Background: Transcatheter mitral valve replacement (TMVR) offers a potential treatment option for select patients with mitral regurgitation (MR) deemed unsuitable for surgery or transcatheter repair, but data is limited on long-term durability and performance.

Aims: We evaluated 5-year outcomes from the global Pilot study (NCT02322840) with the Intrepid transapical (TA) TMVR system.

Methods: This multicenter, single-arm study evaluated the early-generation Intrepid TA system in patients with symptomatic ≥ moderate-severe MR at high risk for mitral valve (MV) surgery. Echocardiograms and clinical events were independently adjudicated, and patients were followed through 5 years.

Results: Ninety-five patients were enrolled at 21 sites between 2015 and 2019. Mean age was 74.0±9.2 years, 43.2% female, mean STS-PROM 6.5±4.8%, 57.9% had prior heart failure hospitalization (HFH), and 88.4% were in NYHA Class III/IV. Secondary MR was present in 78.7%, and 76.6% had a left ventricular ejection fraction ≤50%. Through 5 years, all-cause mortality was 66.7% and HFH 55.4%, with one 30-day MV reintervention (1.1%). Hemodynamic valve deterioration occurred in 1.4%, median MV mean gradient remained stable at 3.6 mmHg (Q1, Q3: 3.0, 4.8 mmHg), with ≤ mild MR in 100% of patients, and none had paravalvular leak. NYHA Class I/II was maintained at 84.6%.

Conclusions: In this 5-year follow-up of the early generation Intrepid TA TMVR system, we observed sustained MR reduction, durable hemodynamic valve performance, and improved functional status among survivors. The APOLLO (NCT03242642) and APOLLO-EU (NCT05496998) trials using the transfemoral system will determine the role of TMVR in managing this high-risk patient population.

背景:经导管二尖瓣置换术(TMVR)为认为不适合手术或经导管修复的二尖瓣返流(MR)患者提供了一种潜在的治疗选择,但关于长期耐久性和性能的数据有限。目的:我们评估了使用Intrepid transapical (TA) TMVR系统的全球试点研究(NCT02322840)的5年结果。方法:这项多中心、单臂研究评估了早期Intrepid TA系统在有症状≥中重度MR、二尖瓣手术高风险患者中的应用。超声心动图和临床事件独立判定,患者随访5年。结果:2015年至2019年期间,在21个地点招募了95名患者。平均年龄74.0±9.2岁,女性43.2%,平均STS-PROM 6.5±4.8%,57.9%有心力衰竭住院史(HFH), 88.4%为NYHA III/IV级。78.7%的患者有继发MR, 76.6%的患者左室射血分数≤50%。5年间,全因死亡率为66.7%,HFH为55.4%,其中30天MV再干预1次(1.1%)。1.4%的患者发生血流动力学瓣膜恶化,中位MV平均梯度稳定在3.6 mmHg (Q1, Q3: 3.0, 4.8 mmHg), 100%的患者MR≤轻度,没有瓣膜旁泄漏。NYHA I/II级维持在84.6%。结论:在这项对早期Intrepid TA TMVR系统的5年随访中,我们观察到幸存者的持续MR降低,持久的血流动力学瓣膜性能和改善的功能状态。使用经股动脉系统的APOLLO (NCT03242642)和APOLLO- eu (NCT05496998)试验将确定TMVR在管理这一高危患者群体中的作用。
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引用次数: 0
Discontinuation of the ACURATE transcatheter heart valve platform: loss or reckoning? 停止使用经导管心脏瓣膜平台:损失还是清算?
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-14 DOI: 10.4244/EIJ-D-25-00692
Won-Keun Kim, Helge Möllmann
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引用次数: 0
Management of patients with transvalvular right ventricular leads undergoing transcatheter tricuspid valve interventions: a scientific statement of the European Heart Rhythm Association and the European Association of Percutaneous Cardiovascular Interventions of the ESC endorsed by the Heart Rhythm Society, the Asian Pacific Heart Rhythm Society and the Canadian Heart Rhythm Society. 经导管三尖瓣介入治疗经瓣右心室导联患者的管理:欧洲心律协会和欧洲经皮心血管介入协会的科学声明,由心律学会、亚太心律学会和加拿大心律学会认可。
IF 9.5 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-14 DOI: 10.4244/EIJ-JAA-202501
Jean-Claude Deharo, Julien Dreyfus, Maria-Grazia Bongiorni, Haran Burri, Pascal Defaye, Michael Glikson, Nigel Lever, Antonio Mangieri, Blandine Mondésert, Jens Cosedis Nielsen, Maully Shah, Christoph Thomas Starck, Archana Rao, Christophe Leclercq, Fabien Praz

Up to one-third of patients referred for transcatheter tricuspid valve intervention (TTVI) have a transvalvular pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) lead in place. Both the electrophysiology and interventional cardiology communities have been alerted to the complexity of decision-making in this situation due to potential interactions between the leads and the TTVI material, including the risk of jailing or damage to the leads. This document, commissioned by the European Heart Rhythm Association and the European Association of Percutaneous Cardiovascular Interventions of the ESC, reviews the scientific evidence to inform Heart Team discussions on the management of patients with a PPM or ICD who are scheduled for or have undergone TTVI. Graphical abstract.

多达三分之一接受经导管三尖瓣介入治疗(TTVI)的患者有经瓣膜起搏器(PPM)或植入式心律转复除颤器(ICD)。由于导联和TTVI材料之间的潜在相互作用,包括导致导联入狱或损伤的风险,电生理学和介入心脏病学界都已注意到在这种情况下决策的复杂性。该文件由欧洲心律协会和欧洲经皮心血管干预协会委托编写,审查了科学证据,为心脏小组讨论计划或已接受TTVI的PPM或ICD患者的管理提供信息。图形抽象。
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引用次数: 0
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