Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.104157
Vladimir Lakhter DO
{"title":"Management of Balloon Pulmonary Angioplasty Complications: An Ounce of Prevention is a Pound of Cure","authors":"Vladimir Lakhter DO","doi":"10.1016/j.jscai.2025.104157","DOIUrl":"10.1016/j.jscai.2025.104157","url":null,"abstract":"","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 104157"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.103994
Kevin R. Bainey MD, MSc , Payam Dehghani MD , Jyotpal Singh PhD , G.B. John Mancini MD , Ross Garberich MS, MBA , Seth Bergstedt MS , Shaun G. Goodman MD , Wah Wah Htun MD , Catherine P. Benziger MD, MPH , Nima Ghasemzadeh MD , Anna E. Bortnick MD, PhD, MSc , Rohan Kankaria MD , Cindy L. Grines MD , Keshav Nayak MD , M. Chadi Alraies MD, MPH , Rajan A.G. Patel MD , Rosa M. Marticorena DClinEpi, PhD , Shy Amlani MD , Santiago Garcia MD , Timothy D. Henry MD
Background
Patients with COVID-19 continue to present with ST-elevation myocardial infarction (STEMI). To date, there have been no core laboratory electrocardiogram (ECG) description of these patients. Accordingly, we aimed to evaluate the ECG characteristics and coronary angiograms of patients hospitalized with COVID-19–associated STEMI.
Methods
In a prespecified analysis from the North American COVID-19 Myocardial Infarction (NACMI) registry, we collected baseline STEMI ECGs in COVID-19–positive patients for core laboratory interpretation (Canadian VIGOUR Centre, Edmonton, Canada), including ST-segment analysis, worst lead ST-elevation (ST-E), sum ST-elevation (ΣST-E), and sum ST deviation (ΣST-D). Available core laboratory angiograms (Cardiovascular Imaging Research Core Laboratory, Vancouver, Canada) were also collected. ECG and angiographic variables associated with in-hospital death were analyzed.
Results
Of the 392 patients, 28.1% died in-hospital. Greater median ST-E (deviation) was observed in those who died (ST-E: 2.20 vs 1.65 mm; P = .006; ΣST-E: 7 vs 5 mm; P = .005; ΣST-D: 11 vs 9 mm; P = .013, respectively). Following adjustment for clinical characteristics, ΣST-D was a positive predictor of in-hospital death (relative risk [RR], 1.03; 95% CI, 1.01-1.05; P = .003). In 173 patients with available coronary angiograms, 32% of the baseline ECGs could not define infarct location (19% with angiography). Following adjustment, only ECG characteristics were independent predictors of in-hospital mortality (ST-E: RR, 1.14; 95% CI, 1.04-1.22; ΣST-E: RR, 1.03; 95% CI. 1.01-1.05: ΣST-D: RR, 1.03; 95% CI, 1.01-1.05).
Conclusions
In COVID-19–positive patients with STEMI, ST-E (deviation) is a predictor of in-hospital mortality and likely reflects microthrombi in multiple territories compromising myocardial perfusion. Our data support ECG as a simple tool to help risk stratify patients with COVID-19–associated STEMI.
新冠肺炎患者持续出现st段抬高型心肌梗死(STEMI)。到目前为止,还没有这些患者的核心实验室心电图(ECG)描述。因此,我们旨在评估covid -19相关STEMI住院患者的ECG特征和冠状动脉造影。方法在北美COVID-19心肌梗死(NACMI)登记中心的预先指定分析中,我们收集了COVID-19阳性患者的基线STEMI心电图进行核心实验室解释(加拿大埃德蒙顿的加拿大血量中心),包括ST段分析、最差导联ST段抬高(ST- e)、ST段抬高总值(ΣST-E)和ST段偏差总值(ΣST-D)。还收集了可用的核心实验室血管造影(心血管成像研究核心实验室,加拿大温哥华)。分析与院内死亡相关的心电图和血管造影变量。结果392例患者中,28.1%在院内死亡。死亡患者的ST-E中位数(偏差)更大(ST-E: 2.20 vs 1.65 mm; P = 0.006; ΣST-E: 7 vs 5 mm; P = 0.005; ΣST-D: 11 vs 9 mm; P = 0.013)。调整临床特征后,ΣST-D是院内死亡的阳性预测因子(相对危险度[RR], 1.03; 95% CI, 1.01-1.05; P = 0.003)。173例有冠状动脉造影的患者中,32%的基线心电图不能确定梗死位置(19%有血管造影)。调整后,只有心电图特征是院内死亡率的独立预测因子(ST-E: RR, 1.14; 95% CI, 1.04-1.22; ΣST-E: RR, 1.03; 95% CI。1.01-1.05: Σst-d: rr, 1.03;95% ci, 1.01-1.05)。结论在covid -19阳性STEMI患者中,ST-E(偏差)是院内死亡率的预测因子,可能反映了多区域微血栓损害心肌灌注。我们的数据支持心电图作为一种简单的工具,帮助对covid -19相关STEMI患者进行风险分层。
{"title":"Baseline ECG Outperforms the Angiogram for Predicting Mortality in COVID-19–Associated STEMI: Insights From the NACMI Registry","authors":"Kevin R. Bainey MD, MSc , Payam Dehghani MD , Jyotpal Singh PhD , G.B. John Mancini MD , Ross Garberich MS, MBA , Seth Bergstedt MS , Shaun G. Goodman MD , Wah Wah Htun MD , Catherine P. Benziger MD, MPH , Nima Ghasemzadeh MD , Anna E. Bortnick MD, PhD, MSc , Rohan Kankaria MD , Cindy L. Grines MD , Keshav Nayak MD , M. Chadi Alraies MD, MPH , Rajan A.G. Patel MD , Rosa M. Marticorena DClinEpi, PhD , Shy Amlani MD , Santiago Garcia MD , Timothy D. Henry MD","doi":"10.1016/j.jscai.2025.103994","DOIUrl":"10.1016/j.jscai.2025.103994","url":null,"abstract":"<div><h3>Background</h3><div>Patients with COVID-19 continue to present with ST-elevation myocardial infarction (STEMI). To date, there have been no core laboratory electrocardiogram (ECG) description of these patients. Accordingly, we aimed to evaluate the ECG characteristics and coronary angiograms of patients hospitalized with COVID-19–associated STEMI.</div></div><div><h3>Methods</h3><div>In a prespecified analysis from the North American COVID-19 Myocardial Infarction (NACMI) registry, we collected baseline STEMI ECGs in COVID-19–positive patients for core laboratory interpretation (Canadian VIGOUR Centre, Edmonton, Canada), including ST-segment analysis, worst lead ST-elevation (ST-E), sum ST-elevation (ΣST-E), and sum ST deviation (ΣST-D). Available core laboratory angiograms (Cardiovascular Imaging Research Core Laboratory, Vancouver, Canada) were also collected. ECG and angiographic variables associated with in-hospital death were analyzed.</div></div><div><h3>Results</h3><div>Of the 392 patients, 28.1% died in-hospital. Greater median ST-E (deviation) was observed in those who died (ST-E: 2.20 vs 1.65 mm; <em>P</em> = .006; ΣST-E: 7 vs 5 mm; <em>P</em> = .005; ΣST-D: 11 vs 9 mm; <em>P</em> = .013, respectively). Following adjustment for clinical characteristics, ΣST-D was a positive predictor of in-hospital death (relative risk [RR], 1.03; 95% CI, 1.01-1.05; <em>P</em> = .003). In 173 patients with available coronary angiograms, 32% of the baseline ECGs could not define infarct location (19% with angiography). Following adjustment, only ECG characteristics were independent predictors of in-hospital mortality (ST-E: RR, 1.14; 95% CI, 1.04-1.22; ΣST-E: RR, 1.03; 95% CI. 1.01-1.05: ΣST-D: RR, 1.03; 95% CI, 1.01-1.05).</div></div><div><h3>Conclusions</h3><div>In COVID-19–positive patients with STEMI, ST-E (deviation) is a predictor of in-hospital mortality and likely reflects microthrombi in multiple territories compromising myocardial perfusion. Our data support ECG as a simple tool to help risk stratify patients with COVID-19–associated STEMI.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 103994"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.104048
Denizhan Ozdemir MD, PhD , Devarshi Vasa BA , Serdar Farhan MD, Manish Vinayak MBBS, James Johnson MD, Vishal Dhulipala MBBS, Amir Hamdan BS, Gina LaRocca MD, MHSc, Annapoorna S. Kini MD, Deepak L. Bhatt MD, MPH, MBA, Samin K. Sharma MD
Background
Coronary computed tomography angiography and coronary artery calcium score (CACS) are rapidly being adopted for the noninvasive assessment of coronary artery disease (CAD). One of the primary limitations of calcium imaging is the inability to assess obstructive lesions in the presence of a high calcium burden. Currently, there is no guidance on what level of coronary artery calcium indicates a high risk of obstructive CAD. We aimed to determine sex-specific CACS thresholds suggestive of obstructive CAD by comparing coronary angiography with adjunctive tools to available CACS information.
Methods
From August 2018 to August 2023, we retrospectively analyzed 1799 consecutive patients' clinical characteristics, angiographic information, and available intracoronary physiological/anatomical testing at a single institution. We evaluated the sex-specific distribution of CACS and its specificity for identifying obstructive CAD at a threshold of 90%.
Results
Baseline characteristics were similar between the obstructive (n = 1223) and nonobstructive (n = 576) CAD groups. A CACS of ≥1000 in women (HR, 2.81; 95% CI, 1.77-4.47; P < .001) and ≥1400 in men (HR, 3.34; 95% CI, 2.23-5.02; P < .001) predicted obstructive CAD at 90% specificity.
Conclusions
A CACS of ≥1000 in women and ≥1400 in men identifies obstructive CAD at 90% specificity. These thresholds should be prospectively validated and may potentially be used to guide the selection of patients who would benefit from intensification of medical therapy or invasive evaluation in the appropriate clinical context.
{"title":"Sex-Specific Coronary Artery Calcium Score Threshold Predictive of Obstructive Coronary Artery Disease","authors":"Denizhan Ozdemir MD, PhD , Devarshi Vasa BA , Serdar Farhan MD, Manish Vinayak MBBS, James Johnson MD, Vishal Dhulipala MBBS, Amir Hamdan BS, Gina LaRocca MD, MHSc, Annapoorna S. Kini MD, Deepak L. Bhatt MD, MPH, MBA, Samin K. Sharma MD","doi":"10.1016/j.jscai.2025.104048","DOIUrl":"10.1016/j.jscai.2025.104048","url":null,"abstract":"<div><h3>Background</h3><div>Coronary computed tomography angiography and coronary artery calcium score (CACS) are rapidly being adopted for the noninvasive assessment of coronary artery disease (CAD). One of the primary limitations of calcium imaging is the inability to assess obstructive lesions in the presence of a high calcium burden. Currently, there is no guidance on what level of coronary artery calcium indicates a high risk of obstructive CAD. We aimed to determine sex-specific CACS thresholds suggestive of obstructive CAD by comparing coronary angiography with adjunctive tools to available CACS information.</div></div><div><h3>Methods</h3><div>From August 2018 to August 2023, we retrospectively analyzed 1799 consecutive patients' clinical characteristics, angiographic information, and available intracoronary physiological/anatomical testing at a single institution. We evaluated the sex-specific distribution of CACS and its specificity for identifying obstructive CAD at a threshold of 90%.</div></div><div><h3>Results</h3><div>Baseline characteristics were similar between the obstructive (n = 1223) and nonobstructive (n = 576) CAD groups. A CACS of ≥1000 in women (HR, 2.81; 95% CI, 1.77-4.47; <em>P</em> < .001) and ≥1400 in men (HR, 3.34; 95% CI, 2.23-5.02; <em>P</em> < .001) predicted obstructive CAD at 90% specificity.</div></div><div><h3>Conclusions</h3><div>A CACS of ≥1000 in women and ≥1400 in men identifies obstructive CAD at 90% specificity. These thresholds should be prospectively validated and may potentially be used to guide the selection of patients who would benefit from intensification of medical therapy or invasive evaluation in the appropriate clinical context.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 104048"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.104047
Tomonari M. Shimoda MD , Yosuke Sakurai MD , Minami Watanabe MD , Shinichi Fukuhara MD , Yujiro Yokoyama MD , Hiroki A. Ueyama MD , Roger J. Laham MD , Michel Pompeu Sá MD, MSc, PhD , Kaveh Hosseini MD , Tsuyoshi Kaneko MD , Toshiki Kuno MD, PhD
Background
Cerebral embolic protection (CEP) devices are designed to reduce procedure-related stroke during transcatheter aortic valve replacement (TAVR). In light of recent randomized controlled trials (RCTs), we performed an updated meta-analysis to evaluate their impact on stroke and mortality.
Methods
We systematically searched PubMed, EMBASE, and Cochrane Central through June 2025 for RCTs comparing TAVR with or without the CEP devices. Outcomes of interest included all stroke, disabling stroke, and all-cause mortality. Data were extracted and pooled using a random-effects frequentist meta-analysis. In addition, a Bayesian meta-analysis was performed with both vague and informative priors to evaluate the probability of a clinically meaningful reduction in stroke.
Results
Eight RCTs with 11,632 patients (CEP group = 5969; control group = 5663) were included. We found no difference in all strokes between the groups (risk ratio, 0.92; 95% CI, 0.74-1.15), nor in disabling stroke or all-cause mortality. In the Bayesian meta-analysis for all strokes using a vague prior, posterior probabilities that the risk ratio was <1, <0.9, and <0.67 were 71.9%, 35.6%, and 0.1%, respectively. For disabling stroke, the probabilities were 89.6%, 73.3%, and 12.1%, respectively. With an informative prior, posterior probabilities for all strokes were 95.9%, 39.0%, and 0% and the probabilities for disabling strokes were 98.3%, 73.8%, and 0%, respectively.
Conclusions
CEP devices did not significantly reduce stroke or mortality during TAVR, and the probability of a clinically meaningful benefit was low. Larger studies with extended follow-up are warranted to clarify their role in contemporary practice.
{"title":"The Utility of Cerebral Protection Devices in Transcatheter Aortic Valve Replacement: A Systematic Review and Bayesian Meta-analysis","authors":"Tomonari M. Shimoda MD , Yosuke Sakurai MD , Minami Watanabe MD , Shinichi Fukuhara MD , Yujiro Yokoyama MD , Hiroki A. Ueyama MD , Roger J. Laham MD , Michel Pompeu Sá MD, MSc, PhD , Kaveh Hosseini MD , Tsuyoshi Kaneko MD , Toshiki Kuno MD, PhD","doi":"10.1016/j.jscai.2025.104047","DOIUrl":"10.1016/j.jscai.2025.104047","url":null,"abstract":"<div><h3>Background</h3><div>Cerebral embolic protection (CEP) devices are designed to reduce procedure-related stroke during transcatheter aortic valve replacement (TAVR). In light of recent randomized controlled trials (RCTs), we performed an updated meta-analysis to evaluate their impact on stroke and mortality.</div></div><div><h3>Methods</h3><div>We systematically searched PubMed, EMBASE, and Cochrane Central through June 2025 for RCTs comparing TAVR with or without the CEP devices. Outcomes of interest included all stroke, disabling stroke, and all-cause mortality. Data were extracted and pooled using a random-effects frequentist meta-analysis. In addition, a Bayesian meta-analysis was performed with both vague and informative priors to evaluate the probability of a clinically meaningful reduction in stroke.</div></div><div><h3>Results</h3><div>Eight RCTs with 11,632 patients (CEP group = 5969; control group = 5663) were included. We found no difference in all strokes between the groups (risk ratio, 0.92; 95% CI, 0.74-1.15), nor in disabling stroke or all-cause mortality. In the Bayesian meta-analysis for all strokes using a vague prior, posterior probabilities that the risk ratio was <1, <0.9, and <0.67 were 71.9%, 35.6%, and 0.1%, respectively. For disabling stroke, the probabilities were 89.6%, 73.3%, and 12.1%, respectively. With an informative prior, posterior probabilities for all strokes were 95.9%, 39.0%, and 0% and the probabilities for disabling strokes were 98.3%, 73.8%, and 0%, respectively.</div></div><div><h3>Conclusions</h3><div>CEP devices did not significantly reduce stroke or mortality during TAVR, and the probability of a clinically meaningful benefit was low. Larger studies with extended follow-up are warranted to clarify their role in contemporary practice.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 104047"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.104046
Andrew M. Goldsweig MD, MS , David E. Thaler MD, PhD , Steven J. Yakubov MD
Background
The Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion (OCCLUFLEX) trial (NCT05069558) is designed to evaluate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is noninferior to closure with the AMPLATZER Talisman PFO Occluder and Gore CARDIOFORM Septal Occluder.
Methods
Enrollment will include 450 subjects across 48 centers in the United States, Canada, and Europe. Enrolled subjects will be older than 18 years of age with no upper age limit, have a cryptogenic stroke likely attributable to paradoxical embolism, as determined by a neurologist and cardiologist following evaluation to exclude other causes of ischemic stroke, and with an echocardiographically confirmed PFO. Eligible subjects will be randomized 1:1 to receive a Occlutech Flex II PFO Occluder or standard of care PFO occluder (either the AMPLATZER or Gore device). Randomization should occur within 5 working days before the procedure. Subjects will be followed with scheduled assessments conducted at discharge, 1 month, 6 months, and 12 months postprocedure and annually to 5 years, transitioning into a postapproval study, contingent upon premarket approval. The primary end point is effective PFO closure at 12 months by echocardiographic bubble study, the secondary end point is nonfatal recurrent stroke through 12 months, and the safety end point is all device- and procedure-related serious adverse events within 12 months including postprocedural atrial fibrillation.
Conclusions
OCCLUFLEX is the first multicenter randomized trial directly comparing PFO closure devices. This trial will offer valuable evidence for physicians, including procedural characteristics, device success, postimplant atrial fibrillation rates, and outcomes in patients aged >60 years.
前瞻性随机多中心对照临床研究比较Occlutech Flex II闭锁器与标准护理闭锁(OCCLUFLEX)试验(NCT05069558)的卵圆孔未闭(PFO)结果,旨在评估使用Occlutech Flex II闭锁器经皮闭锁PFO的效果是否优于AMPLATZER Talisman闭锁器和Gore CARDIOFORM中隔闭锁器。该研究将包括美国、加拿大和欧洲48个中心的450名受试者。纳入的受试者年龄大于18岁,没有年龄上限,有可能归因于矛盾栓塞的隐源性卒中,由神经科医生和心脏病专家在评估排除其他缺血性卒中原因后确定,并有超声心动图证实PFO。符合条件的受试者将按1:1随机分配,接受Occlutech Flex II PFO闭塞器或标准护理PFO闭塞器(AMPLATZER或Gore设备)。随机化应在手术前5个工作日内进行。受试者将在出院时、手术后1个月、6个月和12个月以及每年至5年进行定期评估,根据上市前批准过渡到批准后研究。主要终点是超声心动图气泡研究显示12个月内PFO有效闭合,次要终点是12个月内非致死性复发性卒中,安全性终点是12个月内所有与器械和手术相关的严重不良事件,包括术后心房颤动。结论soccluflex是第一个直接比较PFO闭合装置的多中心随机试验。这项试验将为医生提供有价值的证据,包括手术特征、器械成功、植入后心房颤动发生率和60岁患者的预后。
{"title":"Clinical Investigation of the Safety and Effectiveness of the Occlutech Flex II PFO Occluder: Design and Rationale of the Multicenter, Randomized OCCLUFLEX Trial","authors":"Andrew M. Goldsweig MD, MS , David E. Thaler MD, PhD , Steven J. Yakubov MD","doi":"10.1016/j.jscai.2025.104046","DOIUrl":"10.1016/j.jscai.2025.104046","url":null,"abstract":"<div><h3>Background</h3><div>The Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion (OCCLUFLEX) trial (NCT05069558) is designed to evaluate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is noninferior to closure with the AMPLATZER Talisman PFO Occluder and Gore CARDIOFORM Septal Occluder.</div></div><div><h3>Methods</h3><div>Enrollment will include 450 subjects across 48 centers in the United States, Canada, and Europe. Enrolled subjects will be older than 18 years of age with no upper age limit, have a cryptogenic stroke likely attributable to paradoxical embolism, as determined by a neurologist and cardiologist following evaluation to exclude other causes of ischemic stroke, and with an echocardiographically confirmed PFO. Eligible subjects will be randomized 1:1 to receive a Occlutech Flex II PFO Occluder or standard of care PFO occluder (either the AMPLATZER or Gore device). Randomization should occur within 5 working days before the procedure. Subjects will be followed with scheduled assessments conducted at discharge, 1 month, 6 months, and 12 months postprocedure and annually to 5 years, transitioning into a postapproval study, contingent upon premarket approval. The primary end point is effective PFO closure at 12 months by echocardiographic bubble study, the secondary end point is nonfatal recurrent stroke through 12 months, and the safety end point is all device- and procedure-related serious adverse events within 12 months including postprocedural atrial fibrillation.</div></div><div><h3>Conclusions</h3><div>OCCLUFLEX is the first multicenter randomized trial directly comparing PFO closure devices. This trial will offer valuable evidence for physicians, including procedural characteristics, device success, postimplant atrial fibrillation rates, and outcomes in patients aged >60 years.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 104046"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.104049
Jason B. Katz MD , Kelley Chen MD , Michael J. Cuttica MD , Ruben Mylvaganam MD , Yasmin Raza MD , Maanasi Samant MD , Jordan Durkin PA-C , Kevin Jin BS , Benjamin L. Magod MD , Charles Logan MD , Benjamin H. Freed MD , S. Christopher Malaisrie MD , Stephen F. Chiu MD , Daniel R. Schimmel MD
Balloon pulmonary angioplasty (BPA) is the treatment of choice for patients with chronic thromboembolic pulmonary hypertension who cannot receive pulmonary thromboendarterectomy or who have residual pulmonary hypertension after pulmonary thromboendarterectomy. As BPA volume and expertise have increased, significant strides in refining this technique have improved success and minimized complications; yet, minimal literature exists on appropriate complication management. This review summarizes how interventionalists can prevent, recognize, and manage BPA complications effectively. Operators must first focus on appropriate patient and vessel selection. Lower lung zones coupled with ring-like stenoses and web lesions are more favorable. Increased patient age, tortuous or subtotal lesions, and elevated pulmonary vascular resistance (>6 Wood units) portend a higher risk for complications. Vascular perforation can be treated with balloon tamponade, embolization (gelfoam and/or coils), and covered stents. Massive hemoptysis is managed with intubation and single lung ventilation if needed. As shock is predominantly hemorrhagic and/or cardiogenic, first-line therapies include vasopressors, inodilators, pulmonary vasodilators, and volume resuscitation, whereas mechanical support devices are second-line. Although reperfusion lung injury (RLI) is uncommon, it is generally well tolerated and managed with positive pressure ventilation, high-flow oxygen therapy, and diuresis. Acute kidney injury can be reduced by dilution of contrast dye, use of extension catheters, and procedural planning. Utilization of standard, angle-minimizing techniques, avoidance of high-dose cinefluoroscopy, and digital subtraction angiography minimizes radiation dose. In conclusion, most complications can be avoided or managed effectively without major morbidity or mortality by optimal preparation, patient selection, and commitment to a comprehensive BPA program.
{"title":"Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Identifying and Managing Complications for the Operator","authors":"Jason B. Katz MD , Kelley Chen MD , Michael J. Cuttica MD , Ruben Mylvaganam MD , Yasmin Raza MD , Maanasi Samant MD , Jordan Durkin PA-C , Kevin Jin BS , Benjamin L. Magod MD , Charles Logan MD , Benjamin H. Freed MD , S. Christopher Malaisrie MD , Stephen F. Chiu MD , Daniel R. Schimmel MD","doi":"10.1016/j.jscai.2025.104049","DOIUrl":"10.1016/j.jscai.2025.104049","url":null,"abstract":"<div><div>Balloon pulmonary angioplasty (BPA) is the treatment of choice for patients with chronic thromboembolic pulmonary hypertension who cannot receive pulmonary thromboendarterectomy or who have residual pulmonary hypertension after pulmonary thromboendarterectomy. As BPA volume and expertise have increased, significant strides in refining this technique have improved success and minimized complications; yet, minimal literature exists on appropriate complication management. This review summarizes how interventionalists can prevent, recognize, and manage BPA complications effectively. Operators must first focus on appropriate patient and vessel selection. Lower lung zones coupled with ring-like stenoses and web lesions are more favorable. Increased patient age, tortuous or subtotal lesions, and elevated pulmonary vascular resistance (>6 Wood units) portend a higher risk for complications. Vascular perforation can be treated with balloon tamponade, embolization (gelfoam and/or coils), and covered stents. Massive hemoptysis is managed with intubation and single lung ventilation if needed. As shock is predominantly hemorrhagic and/or cardiogenic, first-line therapies include vasopressors, inodilators, pulmonary vasodilators, and volume resuscitation, whereas mechanical support devices are second-line. Although reperfusion lung injury (RLI) is uncommon, it is generally well tolerated and managed with positive pressure ventilation, high-flow oxygen therapy, and diuresis. Acute kidney injury can be reduced by dilution of contrast dye, use of extension catheters, and procedural planning. Utilization of standard, angle-minimizing techniques, avoidance of high-dose cinefluoroscopy, and digital subtraction angiography minimizes radiation dose. In conclusion, most complications can be avoided or managed effectively without major morbidity or mortality by optimal preparation, patient selection, and commitment to a comprehensive BPA program.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 104049"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.104054
Ryan D. Madder MD , Michael Abiragi MD , Luai Madanat MD , Stacie VanOosterhout MEd , Jessica L. Parker MS , Devraj Sukul MD , David A. McNamara MD, MPH
Background
The contribution of high radiation dose outliers to cumulative occupational radiation dose is understudied.
Methods
Physician radiation data were collected during consecutive coronary cases, and per case doses were ranked by magnitude. The relationship between the per case rank and relative contribution to cumulative dose was summed for cases ≤50th percentile and for cases >90th percentile. A similar methodology was applied for radiation doses among structural interventionalists, interventional echocardiographers, scrub technologists, and nurse circulators. Multivariable logistic regression was fit to identify independent predictors of physician radiation dose >90th percentile during coronary cases.
Results
Across 363 coronary cases, the median physician radiation dose per case was 10.2 (3.2, 35.5) μSv, and the cumulative radiation dose was 13,230 μSv. Coronary cases ≤50th percentile accounted for only 5.0% of the cumulative radiation dose. Cases >90th percentile accounted for 60.3% of the cumulative dose. Cases >90th percentile accounted for 51.3%, 39.9%, 45.8%, and 64.8% of the cumulative dose among structural interventionalists, interventional echocardiographers, scrub technologists, and nurse circulators, respectively. ST-segment elevation myocardial infarction (OR, 6.2; 95% CI, 1.5-26.3; P = .01), percutaneous coronary intervention (OR, 5.6; 95% CI, 2.2-14.2; P < .001), right heart catheterization (OR, 4.4; 95% CI, 1.7-11.7; P = .003), and male sex (OR, 3.2; 95% CI, 1.3-8.0; P = .01) were independently associated with physician radiation dose >90th percentile.
Conclusions
Physician radiation dose outliers contribute disproportionately to the cumulative radiation dose, with cases above the 90th percentile accounting for 60% of the cumulative dose. High radiation dose outliers are an important target for future radiation mitigation efforts.
背景:高辐射剂量异常值对职业性累积辐射剂量的贡献尚未得到充分研究。方法收集连续冠状动脉病例的内科辐射资料,按剂量大小排序。对于≤50百分位的病例和≤90百分位的病例,总结了每例级别与累积剂量的相对贡献之间的关系。类似的方法应用于结构介入医师、介入超声心动图医师、擦洗技师和循环护士的辐射剂量。多变量logistic回归拟合确定冠状动脉病例中医师辐射剂量的独立预测因子>;第90百分位。结果363例冠心病患者中位医师辐射剂量为10.2 (3.2,35.5)μSv /例,累积辐射剂量为13230 μSv /例。冠状动脉≤50百分位的病例仅占累积辐射剂量的5.0%。第90百分位病例占累积剂量的60.3%。第90百分位占结构介入医师累积剂量的51.3%、39.9%、45.8%、循环护士累积剂量的64.8%。st段抬高型心肌梗死(OR, 6.2; 95% CI, 1.5-26.3; P = 0.01)、经皮冠状动脉介入治疗(OR, 5.6; 95% CI, 2.2-14.2; P < 0.001)、右心导管插入术(OR, 4.4; 95% CI, 1.7-11.7; P = 0.003)和男性(OR, 3.2; 95% CI, 1.3-8.0; P = 0.01)与医生的辐射剂量>;第90百分位独立相关。结论医师辐射剂量异常值对累积辐射剂量的贡献不成比例,超过90百分位的病例占累积剂量的60%。高辐射剂量异常值是未来减轻辐射工作的一个重要目标。
{"title":"Relative Contribution of High-Dose Outliers to Cumulative Occupational Radiation Dose in the Catheterization Laboratory","authors":"Ryan D. Madder MD , Michael Abiragi MD , Luai Madanat MD , Stacie VanOosterhout MEd , Jessica L. Parker MS , Devraj Sukul MD , David A. McNamara MD, MPH","doi":"10.1016/j.jscai.2025.104054","DOIUrl":"10.1016/j.jscai.2025.104054","url":null,"abstract":"<div><h3>Background</h3><div>The contribution of high radiation dose outliers to cumulative occupational radiation dose is understudied.</div></div><div><h3>Methods</h3><div>Physician radiation data were collected during consecutive coronary cases, and per case doses were ranked by magnitude. The relationship between the per case rank and relative contribution to cumulative dose was summed for cases ≤50th percentile and for cases >90th percentile. A similar methodology was applied for radiation doses among structural interventionalists, interventional echocardiographers, scrub technologists, and nurse circulators. Multivariable logistic regression was fit to identify independent predictors of physician radiation dose >90th percentile during coronary cases.</div></div><div><h3>Results</h3><div>Across 363 coronary cases, the median physician radiation dose per case was 10.2 (3.2, 35.5) μSv, and the cumulative radiation dose was 13,230 μSv. Coronary cases ≤50th percentile accounted for only 5.0% of the cumulative radiation dose. Cases >90th percentile accounted for 60.3% of the cumulative dose. Cases >90th percentile accounted for 51.3%, 39.9%, 45.8%, and 64.8% of the cumulative dose among structural interventionalists, interventional echocardiographers, scrub technologists, and nurse circulators, respectively. ST-segment elevation myocardial infarction (OR, 6.2; 95% CI, 1.5-26.3; <em>P</em> = .01), percutaneous coronary intervention (OR, 5.6; 95% CI, 2.2-14.2; <em>P</em> < .001), right heart catheterization (OR, 4.4; 95% CI, 1.7-11.7; <em>P</em> = .003), and male sex (OR, 3.2; 95% CI, 1.3-8.0; <em>P</em> = .01) were independently associated with physician radiation dose >90th percentile.</div></div><div><h3>Conclusions</h3><div>Physician radiation dose outliers contribute disproportionately to the cumulative radiation dose, with cases above the 90th percentile accounting for 60% of the cumulative dose. High radiation dose outliers are an important target for future radiation mitigation efforts.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 104054"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.104041
Mangesh Kritya MD , Chloe Kharsa MD, MSc , Gal Sella MD , Devin Olek MS , Bin S. Teh MD , Muhammad Faraz Anwaar MD , Joseph Elias MD , Elia El Hajj MD , Albert E. Raizner MD , Andrew Farach MD , Neal S. Kleiman MD , Alpesh R. Shah MD
Background
In-stent restenosis (ISR) remains a challenging complication following percutaneous coronary intervention, and intravascular brachytherapy (IVBT) has proved to be an important treatment strategy. However, limited data exist on sex-specific outcomes following IVBT.
Methods
This retrospective, single-center cohort study included 223 patients (61 women, 162 men) treated with IVBT for ISR between 2014 and 2023. The primary end points were all-cause mortality, target lesion revascularization, and major adverse cardiovascular events. Secondary outcomes included technical success, myocardial infarction, cardiac death, and heart failure hospitalization. Multivariable Cox regression was used to adjust for clinical and procedural covariates.
Results
Baseline characteristics were largely similar between sexes, except for higher body surface area and diabetes prevalence in men. Procedural success rates did not differ between groups. However, female sex was independently associated with a higher risk of target lesion revascularization (adjusted HR, 1.80; 95% CI, 1.07-3.01; P = .026) and major adverse cardiovascular events (adjusted HR, 1.63; 95% CI, 1.09-2.45; P = .017). Women also had a higher risk of myocardial infarction (adjusted HR, 2.58; 95% CI, 1.29-5.19; P = .008), whereas no significant sex-based differences were observed for all-cause mortality or heart failure hospitalization.
Conclusions
Despite comparable procedural outcomes, women undergoing IVBT for ISR experienced higher rates of adverse cardiovascular events. These findings underscore the need for sex-stratified risk assessment and further prospective research to understand and address sex-based differences in outcomes after IVBT.
背景:支架内再狭窄(ISR)仍然是经皮冠状动脉介入治疗后的一个具有挑战性的并发症,血管内近距离治疗(IVBT)已被证明是一种重要的治疗策略。然而,关于IVBT后性别特异性结果的数据有限。方法该回顾性单中心队列研究纳入了2014年至2023年期间接受IVBT治疗的ISR患者223例(女性61例,男性162例)。主要终点是全因死亡率、靶病变血运重建和主要不良心血管事件。次要结局包括技术成功、心肌梗死、心源性死亡和心力衰竭住院。多变量Cox回归用于调整临床和程序协变量。结果除了男性的体表面积和糖尿病患病率较高外,男女之间的基线特征基本相似。手术成功率在两组间无差异。然而,女性与较高的靶病变血运重建风险(校正后的HR, 1.80; 95% CI, 1.07-3.01; P = 0.026)和主要不良心血管事件(校正后的HR, 1.63; 95% CI, 1.09-2.45; P = 0.017)独立相关。女性发生心肌梗死的风险也较高(校正后HR为2.58;95% CI为1.29-5.19;P = 0.008),而在全因死亡率或心力衰竭住院方面,没有观察到明显的性别差异。结论:尽管有类似的手术结果,接受IVBT治疗ISR的女性有更高的不良心血管事件发生率。这些发现强调了性别分层风险评估和进一步前瞻性研究的必要性,以了解和解决IVBT后基于性别的结果差异。
{"title":"Sex-Based Differences in Long-Term Outcomes Following Intravascular Brachytherapy for In-Stent Restenosis","authors":"Mangesh Kritya MD , Chloe Kharsa MD, MSc , Gal Sella MD , Devin Olek MS , Bin S. Teh MD , Muhammad Faraz Anwaar MD , Joseph Elias MD , Elia El Hajj MD , Albert E. Raizner MD , Andrew Farach MD , Neal S. Kleiman MD , Alpesh R. Shah MD","doi":"10.1016/j.jscai.2025.104041","DOIUrl":"10.1016/j.jscai.2025.104041","url":null,"abstract":"<div><h3>Background</h3><div>In-stent restenosis (ISR) remains a challenging complication following percutaneous coronary intervention, and intravascular brachytherapy (IVBT) has proved to be an important treatment strategy. However, limited data exist on sex-specific outcomes following IVBT.</div></div><div><h3>Methods</h3><div>This retrospective, single-center cohort study included 223 patients (61 women, 162 men) treated with IVBT for ISR between 2014 and 2023. The primary end points were all-cause mortality, target lesion revascularization, and major adverse cardiovascular events. Secondary outcomes included technical success, myocardial infarction, cardiac death, and heart failure hospitalization. Multivariable Cox regression was used to adjust for clinical and procedural covariates.</div></div><div><h3>Results</h3><div>Baseline characteristics were largely similar between sexes, except for higher body surface area and diabetes prevalence in men. Procedural success rates did not differ between groups. However, female sex was independently associated with a higher risk of target lesion revascularization (adjusted HR, 1.80; 95% CI, 1.07-3.01; <em>P</em> = .026) and major adverse cardiovascular events (adjusted HR, 1.63; 95% CI, 1.09-2.45; <em>P</em> = .017). Women also had a higher risk of myocardial infarction (adjusted HR, 2.58; 95% CI, 1.29-5.19; <em>P</em> = .008), whereas no significant sex-based differences were observed for all-cause mortality or heart failure hospitalization.</div></div><div><h3>Conclusions</h3><div>Despite comparable procedural outcomes, women undergoing IVBT for ISR experienced higher rates of adverse cardiovascular events. These findings underscore the need for sex-stratified risk assessment and further prospective research to understand and address sex-based differences in outcomes after IVBT.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 104041"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.103935
Anastasia E.I. Malek DO , Meghali Singhal DO , Wes Soliman MD , Saja Al-Dujaili PhD , Mohammad Al-Khalaf PhD , Brynn Okeson MSc , Carmen Carbajal BSc , Samantha Yim RN, BSN , Jason Boyatt MD , David Lerner DO , Michael Shenoda MD , Joseph Aragon MD
Background
Septal anatomy dictates the complexity of transseptal puncture (TSP) and strongly influences left atrial access for large mitral transcatheter edge-to-edge mitral valve repair. This study aimed to compare 2 TSP needle-based techniques—mechanical needle (MN; BRK Transseptal Needle, Abbott) and radiofrequency-powered needle (RFN; NRG Transseptal Needle, Boston Scientific)—with the VersaCross Large Access system (VLA, Boston Scientific), comprising a radiofrequency wire and 12.5F transseptal introducer.
Methods
This is a retrospective single-center review of consecutive MitraClip (Abbott) cases using MN (n = 28), RFN (n = 55)—both with an 8.5F sheath and pigtail exchange wire, and VLA (n = 109). Procedures were evaluated for TSP success, time to TSP, MitraClip steerable guide catheter (SGC) delivery, clip deployment, and overall procedure time. Acute adverse events were assessed.
Results
The TSP was successful in 100% of cases with no adverse events. The TSP time from groin access was the shortest with VLA (MN, 26.6 ± 18.5 minutes; RFN, 21.3 ± 11.9 minutes; VLA, 15.8 ± 10.0 minutes). VLA required less time to SGC delivery from TSP (MN, 18.4 ± 12.8 minutes; RFN, 9.7 ± 5.1 minutes; VLA, 5.4 ± 4.6 minutes). There were no differences in time to clip deployment between groups. Total procedure time was the lowest with VLA (MN, 138 ± 64 minutes; RFN, 123 ± 63 minutes; VLA, 96 ± 51 minutes). TSP and SGC delivery times were more consistent using VLA than those with MN (P < .001).
Conclusions
Use of VLA allowed for shorter TSP times and more efficient SGC delivery into the left atrium. The choice of transseptal technique can improve overall procedure time, leading to catheterization laboratory predictability and efficiency.
{"title":"Transseptal Device Comparison for Improved Puncture and Streamlined Mitral Edge-To-Edge Repair","authors":"Anastasia E.I. Malek DO , Meghali Singhal DO , Wes Soliman MD , Saja Al-Dujaili PhD , Mohammad Al-Khalaf PhD , Brynn Okeson MSc , Carmen Carbajal BSc , Samantha Yim RN, BSN , Jason Boyatt MD , David Lerner DO , Michael Shenoda MD , Joseph Aragon MD","doi":"10.1016/j.jscai.2025.103935","DOIUrl":"10.1016/j.jscai.2025.103935","url":null,"abstract":"<div><h3>Background</h3><div>Septal anatomy dictates the complexity of transseptal puncture (TSP) and strongly influences left atrial access for large mitral transcatheter edge-to-edge mitral valve repair. This study aimed to compare 2 TSP needle-based techniques—mechanical needle (MN; BRK Transseptal Needle, Abbott) and radiofrequency-powered needle (RFN; NRG Transseptal Needle, Boston Scientific)—with the VersaCross Large Access system (VLA, Boston Scientific), comprising a radiofrequency wire and 12.5F transseptal introducer.</div></div><div><h3>Methods</h3><div>This is a retrospective single-center review of consecutive MitraClip (Abbott) cases using MN (n = 28), RFN (n = 55)—both with an 8.5F sheath and pigtail exchange wire, and VLA (n = 109). Procedures were evaluated for TSP success, time to TSP, MitraClip steerable guide catheter (SGC) delivery, clip deployment, and overall procedure time. Acute adverse events were assessed.</div></div><div><h3>Results</h3><div>The TSP was successful in 100% of cases with no adverse events. The TSP time from groin access was the shortest with VLA (MN, 26.6 ± 18.5 minutes; RFN, 21.3 ± 11.9 minutes; VLA, 15.8 ± 10.0 minutes). VLA required less time to SGC delivery from TSP (MN, 18.4 ± 12.8 minutes; RFN, 9.7 ± 5.1 minutes; VLA, 5.4 ± 4.6 minutes). There were no differences in time to clip deployment between groups. Total procedure time was the lowest with VLA (MN, 138 ± 64 minutes; RFN, 123 ± 63 minutes; VLA, 96 ± 51 minutes). TSP and SGC delivery times were more consistent using VLA than those with MN (<em>P</em> < .001).</div></div><div><h3>Conclusions</h3><div>Use of VLA allowed for shorter TSP times and more efficient SGC delivery into the left atrium. The choice of transseptal technique can improve overall procedure time, leading to catheterization laboratory predictability and efficiency.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 103935"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1016/j.jscai.2025.104002
Abdul Rasheed Bahar MD , Ishaq Khoury MD , Mohamad Hamza MD , Sultana Jahan MD , Mohamad Hasan Jawadi MD , Manisha Guntha MD , Yasemin Bahar MD , Saman Razzaq MD , M. Chadi Alraies MD, MPH
Background
Left atrial appendage occlusion (LAAO) has emerged as a promising adjunctive strategy for stroke prevention in patients with atrial fibrillation (AF) undergoing cardiac surgery. While previous studies have assessed its efficacy, a comprehensive evaluation integrating both randomized controlled trials and observational data remains limited.
Methods
We conducted a systematic review and meta-analysis to evaluate the safety and effectiveness of LAAO compared with no LAAO in patients with AF undergoing cardiac surgery. A total of 20 studies (12 observational and 8 randomized controlled trials) encompassing 215,181 patients treated between 2005 and 2024 were included. Pooled odds ratios with 95% CIs were calculated using fixed- and random-effects models for primary and secondary outcomes, with heterogeneity, publication bias, and sensitivity analyses performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Results
Left atrial appendage occlusion was associated with a significant reduction in ischemic stroke (odds ratio, 0.72; 95% CI, 0.66-0.79), systemic embolism, hemorrhagic stroke, silent cerebral infarcts, and cardiac death. A significant reduction in all-cause mortality was observed using a fixed-effects model, but not with the random-effects model due to substantial heterogeneity. No significant differences were observed in myocardial infarction, peripheral ischemia, or major bleeding events. Sensitivity and cumulative analyses supported the robustness of the ischemic stroke findings. Subgroup analyses revealed no significant variation in outcomes based on study design or publication year.
Conclusions
Left atrial appendage occlusion during cardiac surgery is associated with a significant reduction in thromboembolic events, without increasing the risk of major complications. These findings support the role of LAAO as a safe and effective adjunctive intervention in appropriately selected patients with AF. Further high-quality, prospective studies are warranted to confirm these benefits and inform guideline-directed practice.
背景左心耳闭塞术(LAAO)已成为心房颤动(AF)心脏手术患者预防卒中的一种有前景的辅助策略。虽然以前的研究已经评估了其疗效,但综合随机对照试验和观察数据的综合评估仍然有限。方法通过系统回顾和荟萃分析来评价LAAO与未LAAO在房颤心脏手术患者中的安全性和有效性。共纳入了20项研究(12项观察性试验和8项随机对照试验),包括2005年至2024年间接受治疗的215,181例患者。采用固定效应和随机效应模型计算主要和次要结局的95% ci的合并优势比,并根据系统评价和荟萃分析(PRISMA)指南的首选报告项目进行异质性、发表偏倚和敏感性分析。结果左心耳闭塞与缺血性卒中(优势比0.72;95% CI 0.66-0.79)、全身性栓塞、出血性卒中、无症状性脑梗死和心源性死亡的显著降低相关。使用固定效应模型观察到全因死亡率显著降低,但由于大量异质性,随机效应模型没有观察到全因死亡率的显著降低。在心肌梗死、外周缺血或大出血事件方面没有观察到显著差异。敏感性和累积分析支持缺血性卒中研究结果的稳健性。亚组分析显示,基于研究设计或发表年份的结果无显著差异。结论心脏手术中左心耳闭塞与血栓栓塞事件的显著降低相关,且不会增加主要并发症的风险。这些发现支持LAAO在适当选择的房颤患者中作为一种安全有效的辅助干预措施的作用。需要进一步的高质量前瞻性研究来证实这些益处,并为指导实践提供信息。
{"title":"Surgical Left Atrial Appendage Occlusion During Cardiac Surgery in Atrial Fibrillation: A Contemporary Systematic Review and Meta-Analysis","authors":"Abdul Rasheed Bahar MD , Ishaq Khoury MD , Mohamad Hamza MD , Sultana Jahan MD , Mohamad Hasan Jawadi MD , Manisha Guntha MD , Yasemin Bahar MD , Saman Razzaq MD , M. Chadi Alraies MD, MPH","doi":"10.1016/j.jscai.2025.104002","DOIUrl":"10.1016/j.jscai.2025.104002","url":null,"abstract":"<div><h3>Background</h3><div>Left atrial appendage occlusion (LAAO) has emerged as a promising adjunctive strategy for stroke prevention in patients with atrial fibrillation (AF) undergoing cardiac surgery. While previous studies have assessed its efficacy, a comprehensive evaluation integrating both randomized controlled trials and observational data remains limited.</div></div><div><h3>Methods</h3><div>We conducted a systematic review and meta-analysis to evaluate the safety and effectiveness of LAAO compared with no LAAO in patients with AF undergoing cardiac surgery. A total of 20 studies (12 observational and 8 randomized controlled trials) encompassing 215,181 patients treated between 2005 and 2024 were included. Pooled odds ratios with 95% CIs were calculated using fixed- and random-effects models for primary and secondary outcomes, with heterogeneity, publication bias, and sensitivity analyses performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.</div></div><div><h3>Results</h3><div>Left atrial appendage occlusion was associated with a significant reduction in ischemic stroke (odds ratio, 0.72; 95% CI, 0.66-0.79), systemic embolism, hemorrhagic stroke, silent cerebral infarcts, and cardiac death. A significant reduction in all-cause mortality was observed using a fixed-effects model, but not with the random-effects model due to substantial heterogeneity. No significant differences were observed in myocardial infarction, peripheral ischemia, or major bleeding events. Sensitivity and cumulative analyses supported the robustness of the ischemic stroke findings. Subgroup analyses revealed no significant variation in outcomes based on study design or publication year.</div></div><div><h3>Conclusions</h3><div>Left atrial appendage occlusion during cardiac surgery is associated with a significant reduction in thromboembolic events, without increasing the risk of major complications. These findings support the role of LAAO as a safe and effective adjunctive intervention in appropriately selected patients with AF. Further high-quality, prospective studies are warranted to confirm these benefits and inform guideline-directed practice.</div></div>","PeriodicalId":73990,"journal":{"name":"Journal of the Society for Cardiovascular Angiography & Interventions","volume":"5 1","pages":"Article 104002"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145996408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}