American heart journalPub Date : 2026-02-01Epub Date: 2025-09-25DOI: 10.1016/j.ahj.2025.09.014
Kevin D. Hill MD, MSCI , Jake Koerner MS , Hwanhee Hong PhD , Jennifer S. Li MD, MHS , Christoph Hornik MD, PhD , Prince J. Kannankeril MD, MSCI , Jeffrey P. Jacobs MD , H Scott Baldwin MD , Marshall L. Jacobs MD , Eric M. Graham MD , Brian Blasiole MD, PhD , David F. Vener MD , Adil S. Husain MD , S. Ram Kumar MD, PhD , Alexis Benscoter MD , Eric Wald MD , Tara Karamlou MD, MSc , Andrew H. Van Bergen MD , David Overman MD , Pirooz Eghtesady MD , Sean M. O’Brien PhD
{"title":"A Bayesian re-analysis of the STRESS trial","authors":"Kevin D. Hill MD, MSCI , Jake Koerner MS , Hwanhee Hong PhD , Jennifer S. Li MD, MHS , Christoph Hornik MD, PhD , Prince J. Kannankeril MD, MSCI , Jeffrey P. Jacobs MD , H Scott Baldwin MD , Marshall L. Jacobs MD , Eric M. Graham MD , Brian Blasiole MD, PhD , David F. Vener MD , Adil S. Husain MD , S. Ram Kumar MD, PhD , Alexis Benscoter MD , Eric Wald MD , Tara Karamlou MD, MSc , Andrew H. Van Bergen MD , David Overman MD , Pirooz Eghtesady MD , Sean M. O’Brien PhD","doi":"10.1016/j.ahj.2025.09.014","DOIUrl":"10.1016/j.ahj.2025.09.014","url":null,"abstract":"<div><h3>Background</h3><div>Prophylactic steroids are often used to reduce the systemic inflammatory response to cardiopulmonary bypass in infants undergoing heart surgery. The STRESS trial found that the odds of a worse outcome did not differ between infants randomized to methylprednisolone (n = 599) versus placebo (n = 601) (adjusted odds ratio [OR], 0.86; <em>P</em> = .14). However, secondary analyses showed possible benefits with methylprednisolone. To investigate further using a different probabilistic approach, we re-analyzed the STRESS trial using Bayesian analytics.</div></div><div><h3>Methods</h3><div>We used a covariate-adjusted proportional odds model using the original STRESS trial primary endpoint, a ranked composite of death, transplant, major complication and post op length of stay. We performed Markov Chain Monte Carlo simulations to assess the probability of benefit (OR < 1) versus harm (OR > 1). Primary analysis assumed a neutral probability of benefit versus harm with weak prior belief strength (nearly noninformative prior distribution). To illustrate magnitude of effect, we calculated predicted risk of death, transplant or major complications for methylprednisolone and placebo. Sensitivity analyses evaluated pessimistic (5%-30% prior likelihood of benefit), neutral and optimistic (70%-95%) prior beliefs, and controlled strength of prior belief as weak (30% variance), moderate (15%) and strong (5%). A secondary analysis derived empirical priors using data from four previous steroid trials.</div></div><div><h3>Results</h3><div>The posterior probability of any benefit from methylprednisolone was 92% and probability of harm was 8%. Composite death or major complication occurred in 18.8% of subjects with an absolute risk difference of −2% (95% CI −3%, +1%) for methylprednisolone. Each of 9 sensitivity analyses demonstrated greater probability of benefit than harm in the methylprednisolone group with 8 of 9 demonstrating >80% probability of benefit and ≥1% absolute difference in risk of death, transplant or major complications. In secondary analysis deriving priors from previous steroid trials, results were consistent with a 95% posterior probability of benefit.</div></div><div><h3>Conclusion</h3><div>Our Bayesian re-analysis of the STRESS trial, using a range of prior beliefs, demonstrated a high probability that perioperative methylprednisolone reduces the risk of death or major complications in infants undergoing cardiopulmonary bypass compared with placebo. This more in-depth analysis expands the initial clinical evaluation of methylprednisolone provided by the STRESS trial.</div></div><div><h3>Trial Registration</h3><div>Clinicaltrials.gov: NCT03229538 (<span><span>https://clinicaltrials.gov/study/NCT03229538</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107282"},"PeriodicalIF":3.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145181833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
American heart journalPub Date : 2026-02-01Epub Date: 2025-09-18DOI: 10.1016/j.ahj.2025.09.011
Daijiro Tomii MD , Bashir Alaour MD, PhD , Dik Heg PhD , Taishi Okuno MD , Masaaki Nakase MD , Daryoush Samim MD , Fabien Praz MD , Jonas Lanz MD , Stefan Stortecky MD, MPH , David Reineke MD , Stephan Windecker MD , Thomas Pilgrim MD, MSc
{"title":"Self-expanding versus balloon-expandable transcatheter heart valves in patients with excessive aortic valve cusp calcification","authors":"Daijiro Tomii MD , Bashir Alaour MD, PhD , Dik Heg PhD , Taishi Okuno MD , Masaaki Nakase MD , Daryoush Samim MD , Fabien Praz MD , Jonas Lanz MD , Stefan Stortecky MD, MPH , David Reineke MD , Stephan Windecker MD , Thomas Pilgrim MD, MSc","doi":"10.1016/j.ahj.2025.09.011","DOIUrl":"10.1016/j.ahj.2025.09.011","url":null,"abstract":"<div><h3>Background</h3><div>Excessive aortic cusp calcification increases the risk of periprocedural complications after transcatheter aortic valve replacement (TAVR). Differences in device performance in patients with excessive calcification may affect long-term clinical outcomes.</div></div><div><h3>Objectives</h3><div>To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.</div></div><div><h3>Methods</h3><div>Consecutive patients with severe aortic stenosis and aortic valve complex calcium volume ≥235 mm³ (on contrast images with Hounsfield unit threshold of 850) who underwent TAVR with either CoreValve/Evolut SEV or SAPIEN BEV from August 2007 to June 2023 were included from a prospective-single center registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.</div></div><div><h3>Results</h3><div>Among 1,345 patients with excessive cusp calcification undergoing TAVR, 271 matched pairs were identified. Procedural success was achieved in >85% of patients with no difference between groups. Annular rupture occurred more frequently with BEV compared to SEV (2.2% vs 0%, <em>P</em> = .030). SEV had a lower transprosthetic gradient (8.0 mmHg vs 11.2 mmHg, <em>P</em> < .001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs 58.1%, <em>P</em> = .008) and new permanent pacemaker implantation (22.6% vs 15.5%, <em>P</em> = .001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs 50.2%, <em>P</em> = .173).</div></div><div><h3>Conclusions</h3><div>In patients with excessive leaflet calcification undergoing TAVR, BEV had a higher risk of annular rupture, but a lower risk of paravalvular regurgitation, and a lower risk of permanent pacemaker implantation compared to SEV. Mortality was comparable between SEV and BEV throughout 5 years of follow-up.</div></div><div><h3>Clinical Trial Registration</h3><div><span><span>https://www.clinicaltrials.gov</span><svg><path></path></svg></span>. NCT01368250.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107279"},"PeriodicalIF":3.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145102609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
American heart journalPub Date : 2026-02-01Epub Date: 2025-10-27DOI: 10.1016/j.ahj.2025.107294
Michael P. Dorsch PharmD, MS , Walter Dempsey PhD , Amy Krambrink MS , Sabah Ganai MPH , Kaitlyn M. Greer PhD , Mohamed S. Ali PharmD, SM , Chelsie Gesierich MPH , Margaret O’Neill BA , Brahmajee K. Nallamothu MD, MPH , Scott L. Hummel MD, MS
{"title":"A just-in-time adaptive mobile application intervention to reduce sodium intake and blood pressure in patients with hypertension: Rationale and design of the LowSalt4Life 2 trial","authors":"Michael P. Dorsch PharmD, MS , Walter Dempsey PhD , Amy Krambrink MS , Sabah Ganai MPH , Kaitlyn M. Greer PhD , Mohamed S. Ali PharmD, SM , Chelsie Gesierich MPH , Margaret O’Neill BA , Brahmajee K. Nallamothu MD, MPH , Scott L. Hummel MD, MS","doi":"10.1016/j.ahj.2025.107294","DOIUrl":"10.1016/j.ahj.2025.107294","url":null,"abstract":"<div><h3>Background</h3><div>Excess dietary sodium intake is a major contributor to hypertension (HTN) and cardiovascular disease in the U.S., yet most Americans exceed recommended sodium intake levels. Despite the established benefits of sodium reduction, behavioral adherence remains a challenge. Just-in-time adaptive interventions (JITAIs) provide a novel mobile health (mHealth) strategy to support low-sodium choices in real-time at restaurants and grocery stores.</div></div><div><h3>Methods</h3><div>LowSalt4Life 2 is a 6-month randomized controlled trial evaluating a mobile application-based sodium-focused JITAI among adults with HTN. In phase one, participants were randomized 1:1 to either the LowSalt4Life app with JITAI (App+JITAI) or the app alone. At 2 months, the App+JITAI group was re-randomized to either continue with the standard JITAI or receive a personalized JITAI (pJITAI) informed by reinforcement learning based on prior engagement. The primary outcome was change in systolic blood pressure (SBP) at 2 months. Secondary outcomes included changes in BP medication, dietary sodium intake, and engagement metrics.</div></div><div><h3>Results</h3><div>As of October 2025, 410 participants had been enrolled and completed follow-up. The trial's final results are anticipated in Spring 2025. Primary analysis focuses on the change in SBP between the App+JITAI and App-only groups, as well as the added value of personalization in the second study phase.</div></div><div><h3>Conclusions</h3><div>LowSalt4Life 2 tests a scalable, context-aware digital intervention designed to reduce dietary sodium and improve BP management. By personalizing engagement based on user behavior, this study seeks to advance mHealth strategies for HTN self-management and inform future interventions targeting dietary behaviors in real-world settings.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107294"},"PeriodicalIF":3.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145399795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
American heart journalPub Date : 2026-01-01Epub Date: 2025-08-22DOI: 10.1016/j.ahj.2025.08.008
Richard C. Becker MD
{"title":"Democracy, healthcare, and the public good","authors":"Richard C. Becker MD","doi":"10.1016/j.ahj.2025.08.008","DOIUrl":"10.1016/j.ahj.2025.08.008","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 121-127"},"PeriodicalIF":3.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Distal versus conventional transradial artery access for coronary catheterization in patients with STEMI (DR-STEMI): Rationale and design of an international, multicenter, randomized trial","authors":"Grigorios Tsigkas MD, PhD , Aikaterini Trigka-Vasilakopoulou MD , Anastasios Apostolos MD, MSc , Michael Papafaklis MD, PhD , Giuseppe Colletti MD , Antonio Mugnolo MD , Zoltán Ruzsa MD , Claudiu Ungureanu MD , Dimitrios Nikas MD, PhD , Panagiotis Xaplanteris MD, PhD , Gabriele L Gasparini MD, PhD , Alessandro Sciahbasi MD , Ioannis Tsiafoutis MD , Leonidas E. Poulimenos MD , Matthaios Didagelos MD, PhD , Loukas Pappas MD , Pavlos Stougiannos MD , Michalis Hamilos MD, PhD , Antonios Ziakas MD, PhD , Filippos Timpilis MD , Periklis Davlouros MD, PhD","doi":"10.1016/j.ahj.2025.08.007","DOIUrl":"10.1016/j.ahj.2025.08.007","url":null,"abstract":"<div><h3>Rationale</h3><div>Transradial access (TRA) constitutes the cornerstone for cardiac catheterization and is recommended by <del>the</del> multiple recent guidelines, irrespective of clinical presentation. The existing literature has evaluated distal transradial access (dTRA), as a feasible and safe approach in patients with chronic and acute coronary syndrome, excluding although patients presenting with ST- elevation myocardial infraction (STEMI).</div></div><div><h3>Primary hypothesis</h3><div>The current randomized clinical trial compares dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri‑ and postprocedural characteristics.</div></div><div><h3>Design</h3><div>DR-STEMI is a prospective, open label, European, multicenter randomized-control trial which will include 554 patients (277 patients in each treatment arm). Patients with STEMI, will be screened on an all-comers basis for study inclusion and exclusion criteria, and those eligible will be allocated randomly (1:1), to dTRA versus TRA approach. The primary hypothesis of the study is that dTRA is noninferior to conventional TRA regarding the required time between the puncture of the radial artery and wire crossing of the infarct-related artery (i.e., needle-to-wire time).</div></div><div><h3>Current status</h3><div>Enrollment for the DR-STEMI trial began in May 2024, and as of April 15th<sup>,</sup> 2025, 309 patients have been enrolled in the study. Recruitment is expected to continue for approximately 12 months.</div></div><div><h3>Trial registration</h3><div><span><span>clinicaltrials.gov</span><svg><path></path></svg></span>: NCT05605288</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 73-80"},"PeriodicalIF":3.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
American heart journalPub Date : 2026-01-01Epub Date: 2025-08-06DOI: 10.1016/j.ahj.2025.07.072
Josephine Harrington MD , Rohin K. Reddy MBBS , Anthony Carnicelli MD , Lauren Wilson PhD , Renato D. Lopes MD, MHS, PhD , Bernard J. Gersh MB, ChB, DPhil , Lesley H. Curtis PhD , Sean D. Pokorney MD, MBA , Chiara Melloni MD , Emily C. O’Brien PhD , Christopher B. Granger MD
{"title":"Medicare coverage gap status, adherence to oral anticoagulation, and stroke rates in patients with atrial fibrillation","authors":"Josephine Harrington MD , Rohin K. Reddy MBBS , Anthony Carnicelli MD , Lauren Wilson PhD , Renato D. Lopes MD, MHS, PhD , Bernard J. Gersh MB, ChB, DPhil , Lesley H. Curtis PhD , Sean D. Pokorney MD, MBA , Chiara Melloni MD , Emily C. O’Brien PhD , Christopher B. Granger MD","doi":"10.1016/j.ahj.2025.07.072","DOIUrl":"10.1016/j.ahj.2025.07.072","url":null,"abstract":"<div><h3>Background</h3><div>Prior to 2025, Medicare Part D included a coverage gap during which beneficiaries were responsible for substantially higher portions of medication costs. The impact of this on oral anticoagulant (OAC) prescription fills and subsequent stroke in patients with atrial fibrillation (AF) is not known.</div></div><div><h3>Methods</h3><div>Using Centers for Medicare and Medicaid Services claims data from 2016 to 2018, we evaluated OAC prescription fills in patients with AF by assessing their proportion of days covered on OAC before, during, and after their coverage gap. Hazard of stroke was assessed for patients who entered the coverage gap before entering, while in, and after exiting, the gap.</div></div><div><h3>Results</h3><div>Patients who entered the coverage gap had a 16% decrease in median proportion of days covered from pregap (0.92 [interquartile range 0.80, 0.97]) to in-gap (0.76 [0.41, 0.98]). Proportion of days covered continued to drop for patients who entered and then left the coverage gap, despite regaining coverage (pregap: 0.95 [0.85, 0.98]; in-gap: 0.88 [0.55, 0.97]; postgap: 0.70 [0.00, 1.00]). Patients who entered the gap were at significantly higher risk for stroke while in the gap (HR 2.21, 95% CI 1.91-2.54) and during the combined in-gap and postgap periods (HR 3.13, 95% CI 2.71-3.62).</div></div><div><h3>Conclusions</h3><div>OAC use decreased upon entering the coverage gap and was associated with an increased stroke risk, that persisted for the rest of the calendar year. Health policy decisions regarding Medicare can have unintended adverse public health consequences, highlighting the importance of assessing the impact of such policy changes.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 63-72"},"PeriodicalIF":3.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
American heart journalPub Date : 2026-01-01Epub Date: 2025-10-07DOI: 10.1016/j.ahj.2025.08.015
Haiying Hu BSc, Linjun Wang BSc
{"title":"Statistical methodological limitations and improvement suggestions in the study of vitamin D deficiency and cardiovascular mortality after heart transplantation","authors":"Haiying Hu BSc, Linjun Wang BSc","doi":"10.1016/j.ahj.2025.08.015","DOIUrl":"10.1016/j.ahj.2025.08.015","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 216-217"},"PeriodicalIF":3.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
American heart journalPub Date : 2026-01-01Epub Date: 2025-09-24DOI: 10.1016/j.ahj.2025.08.004
Umaimah Naeem, Huda Abdul Qadir
{"title":"Letter to the editor: Loop and thiazide diuretics and outcomes in heart failure with preserved ejection fraction","authors":"Umaimah Naeem, Huda Abdul Qadir","doi":"10.1016/j.ahj.2025.08.004","DOIUrl":"10.1016/j.ahj.2025.08.004","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Page 213"},"PeriodicalIF":3.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
American heart journalPub Date : 2026-01-01Epub Date: 2025-08-14DOI: 10.1016/j.ahj.2025.08.006
Han-Su Park MD , Chong Hyun Suh , Jung-Min Ahn MD , Do-Yoon Kang MD , Soo-Yeon Ahn MD , Sung-Bong Wee MD , Seung-Han Lee MD , Kyeong-Won Seo MD , Min-Ju Kim MSc , Seung-Jung Park MD , Duk-Woo Park MD
{"title":"Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry","authors":"Han-Su Park MD , Chong Hyun Suh , Jung-Min Ahn MD , Do-Yoon Kang MD , Soo-Yeon Ahn MD , Sung-Bong Wee MD , Seung-Han Lee MD , Kyeong-Won Seo MD , Min-Ju Kim MSc , Seung-Jung Park MD , Duk-Woo Park MD","doi":"10.1016/j.ahj.2025.08.006","DOIUrl":"10.1016/j.ahj.2025.08.006","url":null,"abstract":"<div><h3>Background</h3><div>Cerebral embolization is a common complication following transcatheter aortic valve replacement (TAVR). Cerebral embolic protection (CEP) devices have the potential to reduce embolic burden to the cerebral circulation; however, their effectiveness in real-world patients at high risk of stroke remains insufficiently studied.</div></div><div><h3>Methods</h3><div>As part of imaging study of the prospective Sentinel registry (NCT 05217888), we evaluated the effect of CEP on new cerebral embolism as determined by brain magnetic resonance imaging (MRI) in patients undergoing transfemoral TAVR who were considered at high risk for stroke. The primary endpoint was the number and volume of new cerebral lesions on brain MRI at postprocedure (2 to 7 days) compared to baseline in protected brain territories. The control group consists of enrolled patients in the ADAPT-TAVR trial (NCT03284827), in which TAVR was performed without the use of a CEP device.</div></div><div><h3>Results</h3><div>A total of 219 patients was included (49 in the SENTINEL registry and 170 patients in the ADAPT-TAVR trial). For the primary endpoint, the number and volume of new cerebral lesions was significantly lower in the CEP group than in the control group: the median no. of lesions; 1 (interquartile range [IQR], 1 to 2) vs 6 (IQR, 3 to 10), respectively; difference, -4 [IQR, -6 to -3]; <em>P</em> < .001, and the median volume of lesions; 113.5 mm<sup>3</sup> (IQR, 42.4-206.9) vs 283.5 mm<sup>3</sup> (IQR, 129.7-682.4), respectively; difference, -145.9 [IQR, -296.7 to -67.1]; <em>P</em> < .001). Strokes at 30 days occurred in 1 patient (2.0%) in the CEP group and 2 patients (1.2%) in the control group (<em>P</em> = .64).</div></div><div><h3>Conclusions</h3><div>Among patients who are at high risk for stroke undergoing TAVR, the use of CEP was associated with a significant reduction of new cerebral embolism in protected brain territories. Because the study was underpowered to detect clinically relevant events, the results cannot be considered clinically directive.</div></div><div><h3>Clinical Trail Registration</h3><div><span><span>http://ClinicalTrials.gov</span><svg><path></path></svg></span> (Identifier: NCT05217888).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 44-52"},"PeriodicalIF":3.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}