Pub Date : 2026-02-01Epub Date: 2025-10-31DOI: 10.1016/j.ahj.2025.107299
Jasper Boeddinghaus MD , Paolo Bima MD , Luca Crisanti MD , Dagmar I Keller MD , Ksenija Slankamenac MD PhD , Michael Christ MD , Philipp Schuetz MD , Andrea Wiencierz PhD , Ivo Strebel PhD , Julia Reinhardt PhD , Iryna Vyshnevska MD , Tzu-Ying Tsao MSc , Felix Mahfoud MD , Maria Pia Ruggieri MD , Stephan Steuer MD , Òscar Miró MD , Veli-Pekka Harjola MD , Fulvio Morello MD PhD , Peiman Nazerian MD , Dominik Roth MD PhD , John Parissis MD
Background
International practice guidelines recommend the more rapid European Society of Cardiology (ESC) 0/1h-algorithm for the triage of patients with suspected myocardial infarction (MI) as the preferred option and consider the ESC 0/3h-algorithm as an alternative. However, many centers worldwide have not yet adopted the ESC 0/1h-algorithm in clinical practice due to uncertainty which approach best balances safety and efficacy.
Methods
PRESC1SE-MI (PRospective Evaluation of the European Society of Cardiology 0/1h-algorithm`s Safety and Efficacy for Triage of Patients with Suspected Myocardial Infarction) is an international, investigator-initiated multicenter, stepped-wedge, cluster randomized controlled trial. At least 52,156 consecutive adult patients with nontraumatic acute chest discomfort and suspected MI presenting to the Emergency Department (ED) will be enrolled. Sites still using the ESC 0/3h-algorithm as standard-of-care will be randomized to implement the more rapid ESC 0/1h-algorithm at an early or late implementation step. During the validation phase, participating sites continue to use the ESC 0/3h-algorithm. The co-primary outcomes are a composite of type 1 MI or all-cause death at 30 days (safety), and the length of stay in the ED (efficacy). The trial is designed to show noninferiority for safety and superiority for efficacy, with a power of at least 90%.
Conclusions
PRESC1SE-MI is the largest international multicenter trial to date evaluating the safety and the efficacy of the implementation of the more rapid ESC 0/1h-algorithm at late adopting centers across multiple countries and healthcare systems. Its findings have the potential to improve patient care and reduce healthcare costs.
{"title":"PRospective evaluation of the European Society of Cardiology 0/1h-algorithm`s safety and efficacy for triage of patients with suspected myocardial infarction (PRESC1SE-MI): Rationale and design of a prospective international multicenter stepped-wedge cluster randomized controlled trial","authors":"Jasper Boeddinghaus MD , Paolo Bima MD , Luca Crisanti MD , Dagmar I Keller MD , Ksenija Slankamenac MD PhD , Michael Christ MD , Philipp Schuetz MD , Andrea Wiencierz PhD , Ivo Strebel PhD , Julia Reinhardt PhD , Iryna Vyshnevska MD , Tzu-Ying Tsao MSc , Felix Mahfoud MD , Maria Pia Ruggieri MD , Stephan Steuer MD , Òscar Miró MD , Veli-Pekka Harjola MD , Fulvio Morello MD PhD , Peiman Nazerian MD , Dominik Roth MD PhD , John Parissis MD","doi":"10.1016/j.ahj.2025.107299","DOIUrl":"10.1016/j.ahj.2025.107299","url":null,"abstract":"<div><h3>Background</h3><div>International practice guidelines recommend the more rapid European Society of Cardiology (ESC) 0/1h-algorithm for the triage of patients with suspected myocardial infarction (MI) as the preferred option and consider the ESC 0/3h-algorithm as an alternative. However, many centers worldwide have not yet adopted the ESC 0/1h-algorithm in clinical practice due to uncertainty which approach best balances safety and efficacy.</div></div><div><h3>Methods</h3><div>PRESC1SE-MI (PRospective Evaluation of the European Society of Cardiology 0/1h-algorithm`s Safety and Efficacy for Triage of Patients with Suspected Myocardial Infarction) is an international, investigator-initiated multicenter, stepped-wedge, cluster randomized controlled trial. At least 52,156 consecutive adult patients with nontraumatic acute chest discomfort and suspected MI presenting to the Emergency Department (ED) will be enrolled. Sites still using the ESC 0/3h-algorithm as standard-of-care will be randomized to implement the more rapid ESC 0/1h-algorithm at an early or late implementation step. During the validation phase, participating sites continue to use the ESC 0/3h-algorithm. The co-primary outcomes are a composite of type 1 MI or all-cause death at 30 days (safety), and the length of stay in the ED (efficacy). The trial is designed to show noninferiority for safety and superiority for efficacy, with a power of at least 90%.</div></div><div><h3>Conclusions</h3><div>PRESC1SE-MI is the largest international multicenter trial to date evaluating the safety and the efficacy of the implementation of the more rapid ESC 0/1h-algorithm at late adopting centers across multiple countries and healthcare systems. Its findings have the potential to improve patient care and reduce healthcare costs.</div><div><strong>Trial registration:</strong> <span><span>https://clinicaltrials.gov/study/NCT05649384</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107299"},"PeriodicalIF":3.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145429933","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}
Pub Date : 2026-02-01Epub Date: 2025-11-01DOI: 10.1016/j.ahj.2025.107297
Pal Shah MD , Atreya Mishra MD, MPH , Krupa Patel BS , Tiago Soltes RN, BSN , Khalil Ibrahim MD, FSCAI , Mladen I Vidovich MD, FACC, FSCAI
Background
The MISSION Act of 2018 expanded veterans' access to necessary care at non-Veterans Affairs (VA) facilities. The policy is intended to improve access to timely, high-quality care—particularly for specialized procedures like transcatheter aortic valve replacement (TAVR). However, veterans' preferences regarding specialty care in the community vs within the VA system remain unexplored.
Methods
This cross-sectional quality improvement study surveyed veterans at an urban VA heart center who received referrals to community hospitals between 2018 and 2023 for structural heart disease care. The 14-item survey evaluated satisfaction across 3 key domains—communication, quality, and care coordination—along with overall satisfaction with community and VA care, and preferences for future care delivery settings.
Results
Of 47 veterans who completed the survey, most (78.7%) preferred receiving care at a VA hospital (P < .0001). Veterans reported high satisfaction with both community (mean score 9.15/10) and VA-based care (9.19/10; P = .876). While 64% preferred the VA for future cardiovascular care, this trend did not reach statistical significance (P = .079). In contrast, 78.7% preferred the VA for general healthcare (P < .001). Satisfaction with community care was most strongly associated with staff competence (r = 0.839) and feeling their concerns were heard (r = 0.818). VA satisfaction correlated most strongly with care coordination (r = 0.789) and clear follow-up instructions (r = 0.729). Transportation challenges were reported by 17% of respondents and were significantly associated with preference for community care for general health (P < .001).
Conclusions
Veterans referred for cardiovascular procedures through the MISSION Act reported high satisfaction across settings but expressed a clear preference for VA-based care for general healthcare. These findings suggest that while community care is a valuable tool for improving access, investments in VA-based services remain critical to meeting veteran expectations and preserving care quality.
{"title":"Veteran voices on the MISSION act: Satisfaction and care preferences following community referral for structural heart disease care","authors":"Pal Shah MD , Atreya Mishra MD, MPH , Krupa Patel BS , Tiago Soltes RN, BSN , Khalil Ibrahim MD, FSCAI , Mladen I Vidovich MD, FACC, FSCAI","doi":"10.1016/j.ahj.2025.107297","DOIUrl":"10.1016/j.ahj.2025.107297","url":null,"abstract":"<div><h3>Background</h3><div>The MISSION Act of 2018 expanded veterans' access to necessary care at non-Veterans Affairs (VA) facilities. The policy is intended to improve access to timely, high-quality care—particularly for specialized procedures like transcatheter aortic valve replacement (TAVR). However, veterans' preferences regarding specialty care in the community vs within the VA system remain unexplored.</div></div><div><h3>Methods</h3><div>This cross-sectional quality improvement study surveyed veterans at an urban VA heart center who received referrals to community hospitals between 2018 and 2023 for structural heart disease care. The 14-item survey evaluated satisfaction across 3 key domains—communication, quality, and care coordination—along with overall satisfaction with community and VA care, and preferences for future care delivery settings.</div></div><div><h3>Results</h3><div>Of 47 veterans who completed the survey, most (78.7%) preferred receiving care at a VA hospital (<em>P</em> < .0001). Veterans reported high satisfaction with both community (mean score 9.15/10) and VA-based care (9.19/10; <em>P</em> = .876). While 64% preferred the VA for future cardiovascular care, this trend did not reach statistical significance (<em>P</em> = .079). In contrast, 78.7% preferred the VA for general healthcare (<em>P</em> < .001). Satisfaction with community care was most strongly associated with staff competence (<em>r</em> = 0.839) and feeling their concerns were heard (<em>r</em> = 0.818). VA satisfaction correlated most strongly with care coordination (<em>r</em> = 0.789) and clear follow-up instructions (<em>r</em> = 0.729). Transportation challenges were reported by 17% of respondents and were significantly associated with preference for community care for general health (<em>P</em> < .001).</div></div><div><h3>Conclusions</h3><div>Veterans referred for cardiovascular procedures through the MISSION Act reported high satisfaction across settings but expressed a clear preference for VA-based care for general healthcare. These findings suggest that while community care is a valuable tool for improving access, investments in VA-based services remain critical to meeting veteran expectations and preserving care quality.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107297"},"PeriodicalIF":3.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145436797","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}
Pub 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
Background
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; P = .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.
Methods
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.
Results
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.
Conclusion
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.
背景：在接受心脏手术的婴儿中，预防性类固醇常被用于减少体外循环的全身炎症反应。STRESS试验发现，随机分配给甲基强的松龙组（n=599）和安慰剂组（n=601）的婴儿出现较差结果的几率没有差异（校正优势比[OR]， 0.86； P=0.14）。然而，二次分析显示甲基强的松龙可能有益处。为了使用不同的概率方法进一步研究，我们使用贝叶斯分析重新分析了STRESS试验。方法：我们使用协变量调整的比例优势模型，采用最初的STRESS试验主要终点，死亡、移植、主要并发症和术后住院时间的排序组合。我们进行了马尔可夫链蒙特卡罗模拟来评估收益的概率（OR 1）。初步分析假设利与弊的概率为中性，先验信念强度较弱（几乎是非信息性先验分布）。为了说明效果的程度，我们计算了甲基强的松龙和安慰剂的预测死亡、移植或主要并发症的风险。敏感性分析评估悲观（5%-30%先验获益可能性）、中性和乐观（70%-95%）先验信念，并将控制先验信念的强度分为弱（30%方差）、中等（15%）和强（5%）。二次分析利用先前四次类固醇试验的数据得出经验先验。结果：甲泼尼龙获益的后验概率为92%，伤害的后验概率为8%。18.8%的受试者发生复合死亡或主要并发症，甲基强的松龙的绝对风险差为-2% （95% CI -3%, +1%）。9项敏感性分析中的每一项都显示甲基强的松龙组的获益概率大于危害概率，其中9项分析中有8项显示获益概率为80%以上，死亡、移植或主要并发症风险的绝对差异≥1%。从先前的类固醇试验中获得先验的二次分析结果与95%的后验获益概率一致。结论：我们使用一系列先验信念对STRESS试验进行贝叶斯再分析，证明与安慰剂相比，围手术期甲基强的松龙降低了接受体外循环的婴儿死亡或主要并发症的风险。这项更深入的分析扩展了STRESS试验提供的甲基强的松龙的初步临床评估。试验注册：Clinicaltrials.gov: NCT03229538 （https://clinicaltrials.gov/study/NCT03229538）。
{"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}
Pub 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
Background
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.
Objectives
To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.
Methods
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.
Results
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%, P = .030). SEV had a lower transprosthetic gradient (8.0 mmHg vs 11.2 mmHg, P < .001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs 58.1%, P = .008) and new permanent pacemaker implantation (22.6% vs 15.5%, P = .001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs 50.2%, P = .173).
Conclusions
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.
Clinical Trial Registration
https://www.clinicaltrials.gov. NCT01368250.
背景：主动脉尖过度钙化增加经导管主动脉瓣置换术（TAVR）后围手术期并发症的风险。过度钙化患者的器械性能差异可能影响长期临床结果。目的：比较自扩式（SEV）和球囊可扩式（BEV）假体在TAVR中治疗牙尖钙化过度患者的围术期和远期疗效。方法：从2007年8月至2023年6月，采用CoreValve/Evolut SEV或SAPIEN BEV进行TAVR的严重主动脉瓣狭窄和主动脉瓣复合钙容量≥235 mm³（Hounsfield单位阈值850）的连续患者纳入前瞻性单中心登记。进行1:1倾向匹配分析，以解释各组之间的基线差异。结果：在1345例患者中，鉴定出271对配对。85%的患者手术成功，组间无差异。与SEV相比，BEV的环空破裂发生率更高（2.2% vs 0%, p=0.030）。结论：在接受TAVR的小叶过度钙化的患者中，BEV与SEV相比有更高的环破裂风险，但瓣旁反流的风险较低，永久性起搏器植入的风险较低。在5年的随访中，SEV和BEV的死亡率具有可比性。临床试验注册：https://www.Clinicaltrials: gov. NCT01368250。
{"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}
Pub 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
Background
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.
Methods
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.
Results
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.
Conclusions
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.
{"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}
Pub 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}
Transradial access (TRA) constitutes the cornerstone for cardiac catheterization and is recommended by the 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).
Primary hypothesis
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.
Design
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).
Current status
Enrollment for the DR-STEMI trial began in May 2024, and as of April 15th, 2025, 309 patients have been enrolled in the study. Recruitment is expected to continue for approximately 12 months.
{"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}
Pub 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
Background
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.
Methods
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.
Results
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).
Conclusions
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.
背景：在2025年之前，医疗保险D部分包括一个覆盖缺口，在此期间，受益人承担的药物费用要高得多。这对房颤（AF）患者口服抗凝剂（OAC）处方填充和随后卒中的影响尚不清楚。方法：使用医疗保险和医疗补助服务中心2016-2018年的索赔数据，我们通过评估AF患者在覆盖缺口之前、期间和之后的OAC覆盖天数比例来评估他们的OAC处方填写情况。对在进入覆盖缺口前、进入覆盖缺口时和离开覆盖缺口后进入覆盖缺口的患者进行卒中风险评估。结果：进入覆盖缺口的患者从缺口前（0.92[四分位数间距0.80,0.97]）到缺口内（0.76[0.41,0.98]）的覆盖天数中位数比例减少了16%。尽管重新获得了覆盖，但进入然后离开覆盖缺口的患者的覆盖天数比例继续下降(缺口前：0.95 [0.85,0.98]；间隙：0.88 [0.55,0.97]；后间隙：0.70[0.00,1.00])。进入空当期的患者在空当期（HR 2.21, 95% CI 1.91-2.54）以及空当期和空当期后合并（HR 3.13, 95% CI 2.71-3.62）卒中风险明显较高。结论：OAC的使用在进入覆盖缺口后减少，并与卒中风险增加相关，这种情况在日历年的剩余时间内持续存在。关于医疗保险的卫生政策决定可能产生意想不到的不利公共卫生后果，这突出了评估此类政策变化影响的重要性。
{"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}
Pub 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}
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