Pub Date : 2024-10-28DOI: 10.1016/j.jcin.2024.09.010
Background
Acute limb ischemia is a vascular emergency associated with high rates of limb loss and mortality. As the use of endovascular techniques increases, estimation of rates and predictors of adverse outcomes remains needed.
Objectives
This study sought to assess contemporary outcomes and predictors of adverse events following endovascular treatment of acute limb ischemia in a nationwide, multicenter registry.
Methods
Patients who had peripheral vascular intervention performed for the indication of acute limb ischemia in National Cardiovascular Data Registry Peripheral Vascular Intervention Registry between 2014 and 2020 were included. The primary outcome was a composite of all-cause mortality and major amputation during index hospitalization. Multivariable logistic regression was employed to identify predictors of the composite outcome.
Results
There were 3,541 endovascular procedures performed during the study period. Of these, 132 (3.7%) resulted in death, and 77 (2.2%) resulted in amputation during hospitalization. Thrombolysis catheters were used in 27.7% (n = 981) and thrombectomy catheters in 3.9% (n = 138). Independent predictors of death or amputation included severe lung disease (OR: 1.72; 95% CI: 1.17-2.52), Rutherford Class IIb (OR: 2.44; 95% CI: 1.62-3.65), and end-stage renal disease (OR: 3.94; 95% CI: 0.73-0.85), and preprocedure hemoglobin (OR: 0.78; 95% CI: 0.73- 0.85). Complications included bleeding within 72 hours of intervention (6.7%) and thrombosis (2.8%).
Conclusions
Patients with pre-existing medical comorbidities and those with diminished limb viability were more likely to suffer adverse outcomes. Adverse event rates remain high for patients affected by acute limb ischemia despite its declining incidence.
{"title":"Contemporary Practice Patterns and Outcomes of Endovascular Revascularization of Acute Limb Ischemia","authors":"","doi":"10.1016/j.jcin.2024.09.010","DOIUrl":"10.1016/j.jcin.2024.09.010","url":null,"abstract":"<div><h3>Background</h3><div>Acute limb ischemia is a vascular emergency associated with high rates of limb loss and mortality. As the use of endovascular techniques increases, estimation of rates and predictors of adverse outcomes remains needed.</div></div><div><h3>Objectives</h3><div>This study sought to assess contemporary outcomes and predictors of adverse events following endovascular treatment of acute limb ischemia in a nationwide, multicenter registry.</div></div><div><h3>Methods</h3><div>Patients who had peripheral vascular intervention performed for the indication of acute limb ischemia in National Cardiovascular Data Registry Peripheral Vascular Intervention Registry between 2014 and 2020 were included. The primary outcome was a composite of all-cause mortality and major amputation during index hospitalization. Multivariable logistic regression was employed to identify predictors of the composite outcome.</div></div><div><h3>Results</h3><div>There were 3,541 endovascular procedures performed during the study period. Of these, 132 (3.7%) resulted in death, and 77 (2.2%) resulted in amputation during hospitalization. Thrombolysis catheters were used in 27.7% (n = 981) and thrombectomy catheters in 3.9% (n = 138). Independent predictors of death or amputation included severe lung disease (OR: 1.72; 95% CI: 1.17-2.52), Rutherford Class IIb (OR: 2.44; 95% CI: 1.62-3.65), and end-stage renal disease (OR: 3.94; 95% CI: 0.73-0.85), and preprocedure hemoglobin (OR: 0.78; 95% CI: 0.73- 0.85). Complications included bleeding within 72 hours of intervention (6.7%) and thrombosis (2.8%).</div></div><div><h3>Conclusions</h3><div>Patients with pre-existing medical comorbidities and those with diminished limb viability were more likely to suffer adverse outcomes. Adverse event rates remain high for patients affected by acute limb ischemia despite its declining incidence.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142535115","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}
Pub Date : 2024-10-19DOI: 10.1016/j.jcin.2024.09.061
Xiaofei Gao, Jing Kan, Zhiming Wu, Mohammad Anjun, Xiang Chen, Jing Chen, Imad Sheiban, Gary S Mintz, Jun-Jie Zhang, Gregg W Stone, Shao-Liang Chen
Background: Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) reduces the risk for clinical events in patients with acute coronary syndromes (ACS), compared with angiographic guidance. However, the benefits of IVUS guidance in high-risk patients with diabetes with ACS is uncertain.
Objectives: The aim of this prespecified stratified subgroup analysis from the IVUS-ACS randomized trial was to determine the effectiveness of IVUS-guided PCI vs angiography-guided PCI in patients with diabetes with ACS.
Methods: From August 20, 2019, to October 27, 2022, 1,105 patients with diabetes with ACS were randomized, including 554 patients in the IVUS-guided group and 551 in the angiography-guided group. The primary endpoint was the rate of target vessel failure (TVF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.
Results: At 1-year follow-up, TVF occurred in 20 patients in the IVUS guidance group and in 46 patients in the angiographic guidance group (Kaplan-Meier rates 3.6% vs 8.3%; HR: 0.46; 95% CI: 0.27-0.81; P = 0.007), driven by a reduction in clinically driven target vessel revascularization (0.9% vs 3.8%; P = 0.003). IVUS-guided PCI also reduced the risk for TVF without procedural myocardial infarction (2.0% vs 6.7%; HR: 0.29; 95% CI: 0.15-0.57; P < 0.001) and all-cause mortality (HR: 0.30; 95% CI: 0.10-0.93; P = 0.037). There were no significant differences in the rates of stent thrombosis or major bleeding between the groups.
Conclusions: In the large-scale IVUS-ACS trial, IVUS-guided PCI improved 1-year clinical outcomes in high-risk patients with diabetes with ACS. (1-Month vs 12-Month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials; NCT03971500).
{"title":"IVUS-Guided vs Angiography-Guided PCI in Patients With Diabetes With Acute Coronary Syndromes: The IVUS-ACS Trial.","authors":"Xiaofei Gao, Jing Kan, Zhiming Wu, Mohammad Anjun, Xiang Chen, Jing Chen, Imad Sheiban, Gary S Mintz, Jun-Jie Zhang, Gregg W Stone, Shao-Liang Chen","doi":"10.1016/j.jcin.2024.09.061","DOIUrl":"https://doi.org/10.1016/j.jcin.2024.09.061","url":null,"abstract":"<p><strong>Background: </strong>Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) reduces the risk for clinical events in patients with acute coronary syndromes (ACS), compared with angiographic guidance. However, the benefits of IVUS guidance in high-risk patients with diabetes with ACS is uncertain.</p><p><strong>Objectives: </strong>The aim of this prespecified stratified subgroup analysis from the IVUS-ACS randomized trial was to determine the effectiveness of IVUS-guided PCI vs angiography-guided PCI in patients with diabetes with ACS.</p><p><strong>Methods: </strong>From August 20, 2019, to October 27, 2022, 1,105 patients with diabetes with ACS were randomized, including 554 patients in the IVUS-guided group and 551 in the angiography-guided group. The primary endpoint was the rate of target vessel failure (TVF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.</p><p><strong>Results: </strong>At 1-year follow-up, TVF occurred in 20 patients in the IVUS guidance group and in 46 patients in the angiographic guidance group (Kaplan-Meier rates 3.6% vs 8.3%; HR: 0.46; 95% CI: 0.27-0.81; P = 0.007), driven by a reduction in clinically driven target vessel revascularization (0.9% vs 3.8%; P = 0.003). IVUS-guided PCI also reduced the risk for TVF without procedural myocardial infarction (2.0% vs 6.7%; HR: 0.29; 95% CI: 0.15-0.57; P < 0.001) and all-cause mortality (HR: 0.30; 95% CI: 0.10-0.93; P = 0.037). There were no significant differences in the rates of stent thrombosis or major bleeding between the groups.</p><p><strong>Conclusions: </strong>In the large-scale IVUS-ACS trial, IVUS-guided PCI improved 1-year clinical outcomes in high-risk patients with diabetes with ACS. (1-Month vs 12-Month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials; NCT03971500).</p>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500662","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}
Pub Date : 2024-10-18DOI: 10.1016/j.jcin.2024.10.024
Lennert Minten, Keir McCutcheon, Maarten Vanhaverbeke, Laurine Wouters, Stéphanie Bézy, Pierluigi Lesizza, Sander Jentjens, Pascal Frederiks, Tijs Bringmans, Jens-Uwe Voigt, Tom Adriaenssens, Walter Desmet, Peter Sinnaeve, Steven Jacobs, Peter Verbrugghe, Bart Meuris, Stefan Janssens, William F Fearon, Johan Bennett, Christophe Dubois
Background: Evaluation of myocardial ischemia in patients with aortic valve stenosis (AS) with concomitant coronary artery disease (CAD) and possible microvascular dysfunction (MVD) is challenging because fractional flow reserve (FFR) and resting full-cycle ratio (RFR) have not been validated in this clinical setting.
Objectives: The objectives of this study in patients with AS and CAD are: 1. to describe the relationship between hyperemic and resting indices. 2. to investigate the acute and long-term effects of aortic valve replacement (AVR) on epicardial indices and microvascular function. 3. To assess the impact of these changes on clinical decision making. 4. To determine FFR/RFR ischemia cut-off points in AS.
Methods: In this prospective multicentric study, we performed serial measurements of FFR, RFR, and evaluated MVD by means of coronary flow reserve (CFR), the index of microvascular resistance (IMR) and microvascular resistance reserve (MRR) in patients with severe AS and intermediate-to-severe CAD, before and six months after AVR. Patients underwent myocardial perfusion single-photon emission computed tomography (SPECT) before AVR.
Results: In total, 146 coronary lesions in 116 patients were included. Before AVR, we observed high FFR/RFR discordance according to standard cut-off values: FFR-negative (>0.80)/RFR-positive (≤0.89) in 42.3% (68/137) of these lesions. Acutely after AVR, FFR decreased significantly (-0.0120 ± 0.0192, p=0.0045) while RFR remained stable (0.0140 ± 0.0673, p=0.3089). Six months after AVR, FFR decreased (-0.0279±0.0368) while RFR increased significantly (+0.0410±0.0487) (p<0.0001 for both), resulting in 21.5% (21/98) and 39.8% (39/98) of lesions crossing traditional FFR and RFR cut-off lines, respectively. LV-mass decreased significantly (153.68g ± 44.22 before vs 134.66g ± 37.26 after, p<0.0001). MVD was frequently observed at baseline (32.1% abnormal IMR; 68.6% abnormal MRR) with all microvascular parameters improving after AVR. Most accurate cut-offs to predict ischemia were FFR ≤0.83 and RFR ≤0.85 with comparable accuracy (75-80%).
Conclusions: In patients with severe AS and CAD, FFR ≤0.83 and RFR ≤0.85 appear to predict myocardial ischemia more accurately. Six months after AVR, FFR decreases while RFR increases significantly, with simultaneous decrease of LV mass and improvement of microvascular function.
{"title":"Coronary Physiological Indices to Evaluate Myocardial Ischemia in Patients with Aortic Stenosis Undergoing Valve Replacement.","authors":"Lennert Minten, Keir McCutcheon, Maarten Vanhaverbeke, Laurine Wouters, Stéphanie Bézy, Pierluigi Lesizza, Sander Jentjens, Pascal Frederiks, Tijs Bringmans, Jens-Uwe Voigt, Tom Adriaenssens, Walter Desmet, Peter Sinnaeve, Steven Jacobs, Peter Verbrugghe, Bart Meuris, Stefan Janssens, William F Fearon, Johan Bennett, Christophe Dubois","doi":"10.1016/j.jcin.2024.10.024","DOIUrl":"https://doi.org/10.1016/j.jcin.2024.10.024","url":null,"abstract":"<p><strong>Background: </strong>Evaluation of myocardial ischemia in patients with aortic valve stenosis (AS) with concomitant coronary artery disease (CAD) and possible microvascular dysfunction (MVD) is challenging because fractional flow reserve (FFR) and resting full-cycle ratio (RFR) have not been validated in this clinical setting.</p><p><strong>Objectives: </strong>The objectives of this study in patients with AS and CAD are: 1. to describe the relationship between hyperemic and resting indices. 2. to investigate the acute and long-term effects of aortic valve replacement (AVR) on epicardial indices and microvascular function. 3. To assess the impact of these changes on clinical decision making. 4. To determine FFR/RFR ischemia cut-off points in AS.</p><p><strong>Methods: </strong>In this prospective multicentric study, we performed serial measurements of FFR, RFR, and evaluated MVD by means of coronary flow reserve (CFR), the index of microvascular resistance (IMR) and microvascular resistance reserve (MRR) in patients with severe AS and intermediate-to-severe CAD, before and six months after AVR. Patients underwent myocardial perfusion single-photon emission computed tomography (SPECT) before AVR.</p><p><strong>Results: </strong>In total, 146 coronary lesions in 116 patients were included. Before AVR, we observed high FFR/RFR discordance according to standard cut-off values: FFR-negative (>0.80)/RFR-positive (≤0.89) in 42.3% (68/137) of these lesions. Acutely after AVR, FFR decreased significantly (-0.0120 ± 0.0192, p=0.0045) while RFR remained stable (0.0140 ± 0.0673, p=0.3089). Six months after AVR, FFR decreased (-0.0279±0.0368) while RFR increased significantly (+0.0410±0.0487) (p<0.0001 for both), resulting in 21.5% (21/98) and 39.8% (39/98) of lesions crossing traditional FFR and RFR cut-off lines, respectively. LV-mass decreased significantly (153.68g ± 44.22 before vs 134.66g ± 37.26 after, p<0.0001). MVD was frequently observed at baseline (32.1% abnormal IMR; 68.6% abnormal MRR) with all microvascular parameters improving after AVR. Most accurate cut-offs to predict ischemia were FFR ≤0.83 and RFR ≤0.85 with comparable accuracy (75-80%).</p><p><strong>Conclusions: </strong>In patients with severe AS and CAD, FFR ≤0.83 and RFR ≤0.85 appear to predict myocardial ischemia more accurately. Six months after AVR, FFR decreases while RFR increases significantly, with simultaneous decrease of LV mass and improvement of microvascular function.</p>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545512","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}
Pub Date : 2024-10-17DOI: 10.1016/j.jcin.2024.08.048
David A McNamara, Jeremy Albright, Devraj Sukul, Stanley Chetcuti, Annemarie Forrest, Paul Grossman, Raed M Alnajjar, Himanshu Patel, Hitinder S Gurm, Ryan D Madder
Background: Little is known about institutional radiation doses during transcatheter valve interventions.
Objectives: The authors sought to evaluate institutional variability in radiation doses during transcatheter valve interventions.
Methods: Using a large statewide registry, transcatheter edge-to-edge mitral valve repair, transcatheter mitral valve replacement, and transcatheter aortic valve replacement procedures between January 1, 2020, and December 31, 2022, with an air kerma (AK) recorded were analyzed. Patient and procedural characteristics were compared between cases with AK ≥2 and <2 Gy. Associations of variables with AK ≥2 Gy were investigated using Bayesian random effects modeling and median ORs for the performing hospital.
Results: Among 9,446 procedures across 30 hospitals, median (Q1-Q3) procedural AK was 0.592 Gy (0.348-0.989 Gy) with AK ≥2 Gy in 533 cases (5.6%). Wide variation in procedural AK was observed, with an institutional frequency of AK ≥2 Gy ranging from 0.0% to 29.5%. Bayesian modeling identified the performing hospital as more strongly associated with the odds of a procedural AK ≥2 Gy than any patient or procedural factors (hospital median OR: 3.54 [95% credible interval: 2.52-16.66]).
Conclusions: In a large, multicenter state-wide registry, there is wide institutional variability in patient-level radiation doses during transcatheter valve interventions, with the performing hospital having a higher odds of an AK ≥2 Gy than any patient or procedural factors. Future interventions are warranted to reduce procedural-related variation in radiation exposure.
{"title":"Institutional Variation in Patient Radiation Doses During Transcatheter Valve Interventions: A Statewide Experience.","authors":"David A McNamara, Jeremy Albright, Devraj Sukul, Stanley Chetcuti, Annemarie Forrest, Paul Grossman, Raed M Alnajjar, Himanshu Patel, Hitinder S Gurm, Ryan D Madder","doi":"10.1016/j.jcin.2024.08.048","DOIUrl":"https://doi.org/10.1016/j.jcin.2024.08.048","url":null,"abstract":"<p><strong>Background: </strong>Little is known about institutional radiation doses during transcatheter valve interventions.</p><p><strong>Objectives: </strong>The authors sought to evaluate institutional variability in radiation doses during transcatheter valve interventions.</p><p><strong>Methods: </strong>Using a large statewide registry, transcatheter edge-to-edge mitral valve repair, transcatheter mitral valve replacement, and transcatheter aortic valve replacement procedures between January 1, 2020, and December 31, 2022, with an air kerma (AK) recorded were analyzed. Patient and procedural characteristics were compared between cases with AK ≥2 and <2 Gy. Associations of variables with AK ≥2 Gy were investigated using Bayesian random effects modeling and median ORs for the performing hospital.</p><p><strong>Results: </strong>Among 9,446 procedures across 30 hospitals, median (Q1-Q3) procedural AK was 0.592 Gy (0.348-0.989 Gy) with AK ≥2 Gy in 533 cases (5.6%). Wide variation in procedural AK was observed, with an institutional frequency of AK ≥2 Gy ranging from 0.0% to 29.5%. Bayesian modeling identified the performing hospital as more strongly associated with the odds of a procedural AK ≥2 Gy than any patient or procedural factors (hospital median OR: 3.54 [95% credible interval: 2.52-16.66]).</p><p><strong>Conclusions: </strong>In a large, multicenter state-wide registry, there is wide institutional variability in patient-level radiation doses during transcatheter valve interventions, with the performing hospital having a higher odds of an AK ≥2 Gy than any patient or procedural factors. Future interventions are warranted to reduce procedural-related variation in radiation exposure.</p>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500659","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}
Pub Date : 2024-10-16DOI: 10.1016/j.jcin.2024.09.057
Thomas Attumalil, Sami Alnasser, Gianluigi Bisleri, Geraldine Ong, Neil P Fam
{"title":"Use of a Septal Occluder to Treat Recurrent Tricuspid Regurgitation After TriClip.","authors":"Thomas Attumalil, Sami Alnasser, Gianluigi Bisleri, Geraldine Ong, Neil P Fam","doi":"10.1016/j.jcin.2024.09.057","DOIUrl":"https://doi.org/10.1016/j.jcin.2024.09.057","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545515","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}
Pub Date : 2024-10-16DOI: 10.1016/j.jcin.2024.10.020
Amit N Vora, Lucy A Pereira, Chengan Du, Zhen Tan, Chien Yu Huang, Daniel J Friedman, Yongfei Wang, Kamil F Faridi, Dhanunjaya R Lakkireddy, Sarah Zimmerman, Angela Y Higgins, Samir R Kapadia, Jeptha P Curtis, James V Freeman
Background: Percutaneous left atrial appendage occlusion (LAAO) is indicated in patients with atrial fibrillation for whom long-term oral anticoagulation is contraindicated. Whether outcomes are different based on operator certification [interventional cardiology (IC) versus electrophysiology (EP)] is unclear.
Objectives: To compare LAAO outcomes by physician certification (EP versus IC) in the NCDR LAAO Registry.
Methods: We identified patients from 2020-2022 undergoing implantation of a Watchman FLX or Amulet LAAO device and stratified patients by primary operator certification. Outcomes of interest included: (1) any major adverse event (MAE), 2) mortality, 3) ischemic stroke, and 4) major bleeding during the initial hospitalization and at 45 days. We performed multivariable Cox proportional hazards regression analysis to determine the risk of adverse events by physician certification.
Results: A total of 1,638 physicians (57% electrophysiologists) performing 91,711 procedures during the study period were included. EPs were more likely to use intracardiac echocardiography (25.2% vs 9.7%, p<0.001) and had lower radiation total (235 mGy vs 305 mGy, p<0.001). EPs were more likely than ICs to discharge patients on DOAC+aspirin, whereas ICs were more likely to discharge patients on single or dual antiplatelet therapy (all p<0.001). In-hospital death (0.1% vs. 0.1%, p=0.46) and MAE (1.5% vs 1.6%, p=0.42) were similar by physician certification. At 45 days, there was no difference in death [HRdeath 1.03, 95% CI (0.89-1.2)] or MAE [HRMAE 0.97, 95% CI (0.91-1.03)] after multivariable regression.
Conclusions: Contemporary LAAO is safe with low rates of procedural complications and no significant differences in procedural outcomes by operator subspecialty after multivariable adjustment. Continued utilization of technology by EPs and ICs is necessary to allow for broad access to this treatment for eligible patients.
背景:经皮左心房阑尾封堵术(LAAO)适用于禁忌长期口服抗凝药的心房颤动患者。介入心脏病学(IC)与电生理学(EP)]操作者认证的结果是否不同尚不清楚:比较 NCDR LAAO 注册中不同医师认证(EP 与 IC)的 LAAO 结果:我们确定了 2020-2022 年期间接受 Watchman FLX 或 Amulet LAAO 装置植入的患者,并根据主要操作者认证对患者进行了分层。相关结果包括(1) 任何重大不良事件 (MAE);2) 死亡率;3) 缺血性中风;4) 首次住院期间和 45 天内的大出血。我们进行了多变量考克斯比例危险回归分析,以确定不同医生认证的不良事件风险:在研究期间,共有 1638 名医生(57% 为电生理学家)实施了 91,711 例手术。多变量回归后,电生理学家更有可能使用心内超声心动图(25.2% vs 9.7%,pdeath 1.03,95% CI (0.89-1.2)]或 MAE [HRMAE 0.97,95% CI (0.91-1.03)]:结论:当代 LAAO 是安全的,手术并发症发生率低,经多变量调整后,手术结果与操作者的亚专科无明显差异。为了让符合条件的患者能够广泛接受这种治疗,EP 和 IC 有必要继续利用该技术。
{"title":"Association of Physician Certification and Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion.","authors":"Amit N Vora, Lucy A Pereira, Chengan Du, Zhen Tan, Chien Yu Huang, Daniel J Friedman, Yongfei Wang, Kamil F Faridi, Dhanunjaya R Lakkireddy, Sarah Zimmerman, Angela Y Higgins, Samir R Kapadia, Jeptha P Curtis, James V Freeman","doi":"10.1016/j.jcin.2024.10.020","DOIUrl":"https://doi.org/10.1016/j.jcin.2024.10.020","url":null,"abstract":"<p><strong>Background: </strong>Percutaneous left atrial appendage occlusion (LAAO) is indicated in patients with atrial fibrillation for whom long-term oral anticoagulation is contraindicated. Whether outcomes are different based on operator certification [interventional cardiology (IC) versus electrophysiology (EP)] is unclear.</p><p><strong>Objectives: </strong>To compare LAAO outcomes by physician certification (EP versus IC) in the NCDR LAAO Registry.</p><p><strong>Methods: </strong>We identified patients from 2020-2022 undergoing implantation of a Watchman FLX or Amulet LAAO device and stratified patients by primary operator certification. Outcomes of interest included: (1) any major adverse event (MAE), 2) mortality, 3) ischemic stroke, and 4) major bleeding during the initial hospitalization and at 45 days. We performed multivariable Cox proportional hazards regression analysis to determine the risk of adverse events by physician certification.</p><p><strong>Results: </strong>A total of 1,638 physicians (57% electrophysiologists) performing 91,711 procedures during the study period were included. EPs were more likely to use intracardiac echocardiography (25.2% vs 9.7%, p<0.001) and had lower radiation total (235 mGy vs 305 mGy, p<0.001). EPs were more likely than ICs to discharge patients on DOAC+aspirin, whereas ICs were more likely to discharge patients on single or dual antiplatelet therapy (all p<0.001). In-hospital death (0.1% vs. 0.1%, p=0.46) and MAE (1.5% vs 1.6%, p=0.42) were similar by physician certification. At 45 days, there was no difference in death [HR<sub>death</sub> 1.03, 95% CI (0.89-1.2)] or MAE [HR<sub>MAE</sub> 0.97, 95% CI (0.91-1.03)] after multivariable regression.</p><p><strong>Conclusions: </strong>Contemporary LAAO is safe with low rates of procedural complications and no significant differences in procedural outcomes by operator subspecialty after multivariable adjustment. Continued utilization of technology by EPs and ICs is necessary to allow for broad access to this treatment for eligible patients.</p>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545511","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}
Pub Date : 2024-10-16DOI: 10.1016/j.jcin.2024.10.023
Lukas Stolz, Karl-Patrik Kresoja, Jennifer von Stein, Vera Fortmeier, Benedikt Koell, Wolfgang Rottbauer, Mohammad Kassar, Bjoern Goebel, Paolo Denti, Paul Achouh, Tienush Rassaf, Manuel Barreiro-Perez, Peter Boekstegers, Andreas Rück, Philipp M Doldi, Julia Novotny, Monika Zdanyte, Marianna Adamo, Flavien Vincent, Philipp Lurz, Ralph-Stephan von Bardeleben, Thomas J Stocker, Ludwig T Weckbach, Mirjam G Wild, Christian Besler, Stephanie Brunner, Stefan Toggweiler, Julia Grapsa, Tiffany Patterson, Holger Thiele, Tobias Kister, Giuseppe Tarantini, Giulia Masiero, Marco De Carlo, Alessandro Sticchi, Mathias H Konstandin, Eric Van Belle, Marco Metra, Tobias Geisler, Rodrigo Estévez-Loureiro, Peter Luedike, Nicole Karam, Francesco Maisano, Philipp Lauten, Fabien Praz, Mirjam Kessler, Daniel Kalbacher, Volker Rudolph, Christos Iliadis, Philipp Lurz, Jörg Hausleiter, Roman Pfister, Stephan Baldus, Muhammed Gerçek, Felix Rudolph, Sebastian Ludwig, Christoph Pauschinger, Leonhard-Moritz Schneider, Dominik Felbel, Carsten Salomon, Harald Lapp, Tania Puscas, Alain Berrebi, Amir Abbas Mahabadi, Florian Schindhelm, Berenice Caneiro-Queija, Julio C Echarte, Jürgen Schreieck, Andreas Goldschmied, Edoardo Pancaldi, Daniela Tomasoni, Natacha Rousse, Samy Aghezzaf, Norbert Frey, Martin Kraus, Dirk Westermann, Sebastian Rosch, Federico Arturi, Andrea Panza, Matteo Mazzola, Cristina Giannini
Background: Data regarding the association of pulmonary hypertension (PH) and outcomes in patients undergoing transcatheter tricuspid valve edge-to-edge repair (T-TEER) are scarce.
Objectives: To 1) investigate the impact of PH on outcomes after T-TEER and 2) to shed further light into the role of pre- and postcapillary PH in patients undergoing T-TEER for relevant tricuspid regurgitation (TR).
Methods: The study included patients from the EuroTR registry (NCT06307262) who underwent T-TEER for relevant TR from 2016 until 2023 with available invasive evaluation of sPAP using right heart catheterization. Study endpoints were procedural TR reduction, improvement in New York Heart Association (NYHA) function class and a combined endpoint of death or heart failure hospitalization (HFH) at two-years.
Results: Among a total of 1230 patients (mean age 78.6 ±7.0 years; 51.4% women) increasing systolic pulmonary artery pressure (sPAP) was independently associated with increasing rates of two-year death or HFH (hazard ratio 1.027, 95% confidence interval 1.003-1.052, p=0.030; median survival follow up 343 (114-645) days). No significant survival differences were observed for patients with pre- vs. postcapillary PH. Sensitivity analysis revealed a sPAP value of 46 mmHg as optimized threshold for prediction of death or HFH. Being observed in 526 patients (42.8%), elevated sPAP > 46 mmHg was associated with more severe heart failure symptoms at baseline and follow-up. Importantly, NYHA functional class and TR severity significantly improved irrespective of PH.
Conclusion: PH is an important outcome predictor in patients undergoing T-TEER for relevant TR. In contrast to previous studies, no significant differences were observed for patients with pre- and postcapillary PH in terms of survival free from HFH.
{"title":"Impact of Pulmonary Hypertension on Outcomes after Transcatheter Tricuspid Valve Edge-to-Edge Repair.","authors":"Lukas Stolz, Karl-Patrik Kresoja, Jennifer von Stein, Vera Fortmeier, Benedikt Koell, Wolfgang Rottbauer, Mohammad Kassar, Bjoern Goebel, Paolo Denti, Paul Achouh, Tienush Rassaf, Manuel Barreiro-Perez, Peter Boekstegers, Andreas Rück, Philipp M Doldi, Julia Novotny, Monika Zdanyte, Marianna Adamo, Flavien Vincent, Philipp Lurz, Ralph-Stephan von Bardeleben, Thomas J Stocker, Ludwig T Weckbach, Mirjam G Wild, Christian Besler, Stephanie Brunner, Stefan Toggweiler, Julia Grapsa, Tiffany Patterson, Holger Thiele, Tobias Kister, Giuseppe Tarantini, Giulia Masiero, Marco De Carlo, Alessandro Sticchi, Mathias H Konstandin, Eric Van Belle, Marco Metra, Tobias Geisler, Rodrigo Estévez-Loureiro, Peter Luedike, Nicole Karam, Francesco Maisano, Philipp Lauten, Fabien Praz, Mirjam Kessler, Daniel Kalbacher, Volker Rudolph, Christos Iliadis, Philipp Lurz, Jörg Hausleiter, Roman Pfister, Stephan Baldus, Muhammed Gerçek, Felix Rudolph, Sebastian Ludwig, Christoph Pauschinger, Leonhard-Moritz Schneider, Dominik Felbel, Carsten Salomon, Harald Lapp, Tania Puscas, Alain Berrebi, Amir Abbas Mahabadi, Florian Schindhelm, Berenice Caneiro-Queija, Julio C Echarte, Jürgen Schreieck, Andreas Goldschmied, Edoardo Pancaldi, Daniela Tomasoni, Natacha Rousse, Samy Aghezzaf, Norbert Frey, Martin Kraus, Dirk Westermann, Sebastian Rosch, Federico Arturi, Andrea Panza, Matteo Mazzola, Cristina Giannini","doi":"10.1016/j.jcin.2024.10.023","DOIUrl":"https://doi.org/10.1016/j.jcin.2024.10.023","url":null,"abstract":"<p><strong>Background: </strong>Data regarding the association of pulmonary hypertension (PH) and outcomes in patients undergoing transcatheter tricuspid valve edge-to-edge repair (T-TEER) are scarce.</p><p><strong>Objectives: </strong>To 1) investigate the impact of PH on outcomes after T-TEER and 2) to shed further light into the role of pre- and postcapillary PH in patients undergoing T-TEER for relevant tricuspid regurgitation (TR).</p><p><strong>Methods: </strong>The study included patients from the EuroTR registry (NCT06307262) who underwent T-TEER for relevant TR from 2016 until 2023 with available invasive evaluation of sPAP using right heart catheterization. Study endpoints were procedural TR reduction, improvement in New York Heart Association (NYHA) function class and a combined endpoint of death or heart failure hospitalization (HFH) at two-years.</p><p><strong>Results: </strong>Among a total of 1230 patients (mean age 78.6 ±7.0 years; 51.4% women) increasing systolic pulmonary artery pressure (sPAP) was independently associated with increasing rates of two-year death or HFH (hazard ratio 1.027, 95% confidence interval 1.003-1.052, p=0.030; median survival follow up 343 (114-645) days). No significant survival differences were observed for patients with pre- vs. postcapillary PH. Sensitivity analysis revealed a sPAP value of 46 mmHg as optimized threshold for prediction of death or HFH. Being observed in 526 patients (42.8%), elevated sPAP > 46 mmHg was associated with more severe heart failure symptoms at baseline and follow-up. Importantly, NYHA functional class and TR severity significantly improved irrespective of PH.</p><p><strong>Conclusion: </strong>PH is an important outcome predictor in patients undergoing T-TEER for relevant TR. In contrast to previous studies, no significant differences were observed for patients with pre- and postcapillary PH in terms of survival free from HFH.</p>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":null,"pages":null},"PeriodicalIF":11.7,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545513","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}