Pub Date : 2025-11-01DOI: 10.1016/j.ahj.2025.107293
Kimberley I. Hemelrijk MD , Victor A. Jimenez-Diaz MD PhD , Jean Paul Vilchez MD , Juan F Oteo MD , Ivan Gomez-Blazquez MD , Manel Sabate MD, PhD , Victoria Vilalta MD PhD , Alberto Berenguer Jofresa MD FESC , Lluis Asmarats MD, PhD , Ignacio J Amat-Santos MD PhD , Antonio Tello-Montoliu MD , Jose M. de la Torre Hernandez MD, PhD , Xacobe Flores MD , Livia Gheorghe MD , Vicente Peral MD , Antonio J Muñoz-Garcia MD , Fernando Alfonso MD , Gabriela Tirado-Conte MD , Salvatore Brugaletta MD PhD , Gabriela Veiga MD, PhD , Luis Nombela-Franco MD PhD
Background
Patients undergoing transcatheter aortic valve implantation (TAVI) frequently experience life-threatening ischemic and bleeding complications. However, management of antithrombotic therapy after TAVI in patients without oral anticoagulation (OAC), particularly in patients with high burden for subsequent ischemic events, has limited evidence from randomized controlled trials.
Methods
The REAC TAVI2 trial is a prospective, multicenter, open-label, phase III randomized trial (NCT05283356). A total of 1206 patients undergoing TAVI with high ischemic risk (defined as concomitant coronary artery disease, diabetes mellitus or peripheral vascular disease) will be randomized in a 1:1 ratio to single antiplatelet therapy with aspirin (100 mg once daily) or low-dose ticagrelor (60 mg twice daily). The primary endpoint is the incidence of a net adverse clinical event (NACE) at 1-year after TAVI. NACE is defined as a composite of all-cause mortality, cerebrovascular events, myocardial infarction, progressive angina leading to emergency evaluation, rehospitalization or new coronary angiogram, clinical valve thrombosis, acute limb ischemia leading to hospitalization, and type 2, 3, or 5 bleeding. The secondary endpoint is the incidence of subclinical valve thrombosis detected by hypo-attenuated leaflet thickening and reduced leaflet motion at 3 and 12 months post-TAVI assessed by 4-dimensional computed tomography.
Summary
In patients undergoing TAVI without an indication for OAC, there is a need for antiplatelet therapy that provides protection against ischemic events without increasing bleeding, particularly in the subset of patients at heightened risk of ischemic events. The REAC-TAVI 2 is a randomized multicenter clinical trial designed to study the effect of single antiplatelet therapy with aspirin compared to low-dose ticagrelor on a composite outcome of all-cause mortality, ischemic, and bleeding events after TAVI.
{"title":"Rationale and design of REAC-TAVI 2: Single antiplatelet treatment with ticagrelor vs aspirin after transcatheter aortic valve implantation","authors":"Kimberley I. Hemelrijk MD , Victor A. Jimenez-Diaz MD PhD , Jean Paul Vilchez MD , Juan F Oteo MD , Ivan Gomez-Blazquez MD , Manel Sabate MD, PhD , Victoria Vilalta MD PhD , Alberto Berenguer Jofresa MD FESC , Lluis Asmarats MD, PhD , Ignacio J Amat-Santos MD PhD , Antonio Tello-Montoliu MD , Jose M. de la Torre Hernandez MD, PhD , Xacobe Flores MD , Livia Gheorghe MD , Vicente Peral MD , Antonio J Muñoz-Garcia MD , Fernando Alfonso MD , Gabriela Tirado-Conte MD , Salvatore Brugaletta MD PhD , Gabriela Veiga MD, PhD , Luis Nombela-Franco MD PhD","doi":"10.1016/j.ahj.2025.107293","DOIUrl":"10.1016/j.ahj.2025.107293","url":null,"abstract":"<div><h3>Background</h3><div>Patients undergoing transcatheter aortic valve implantation (TAVI) frequently experience life-threatening ischemic and bleeding complications. However, management of antithrombotic therapy after TAVI in patients without oral anticoagulation (OAC), particularly in patients with high burden for subsequent ischemic events, has limited evidence from randomized controlled trials.</div></div><div><h3>Methods</h3><div>The REAC TAVI2 trial is a prospective, multicenter, open-label, phase III randomized trial (NCT05283356). A total of 1206 patients undergoing TAVI with high ischemic risk (defined as concomitant coronary artery disease, diabetes mellitus or peripheral vascular disease) will be randomized in a 1:1 ratio to single antiplatelet therapy with aspirin (100 mg once daily) or low-dose ticagrelor (60 mg twice daily). The primary endpoint is the incidence of a net adverse clinical event (NACE) at 1-year after TAVI. NACE is defined as a composite of all-cause mortality, cerebrovascular events, myocardial infarction, progressive angina leading to emergency evaluation, rehospitalization or new coronary angiogram, clinical valve thrombosis, acute limb ischemia leading to hospitalization, and type 2, 3, or 5 bleeding. The secondary endpoint is the incidence of subclinical valve thrombosis detected by hypo-attenuated leaflet thickening and reduced leaflet motion at 3 and 12 months post-TAVI assessed by 4-dimensional computed tomography.</div></div><div><h3>Summary</h3><div>In patients undergoing TAVI without an indication for OAC, there is a need for antiplatelet therapy that provides protection against ischemic events without increasing bleeding, particularly in the subset of patients at heightened risk of ischemic events. The REAC-TAVI 2 is a randomized multicenter clinical trial designed to study the effect of single antiplatelet therapy with aspirin compared to low-dose ticagrelor on a composite outcome of all-cause mortality, ischemic, and bleeding events after TAVI.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107293"},"PeriodicalIF":3.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145429941","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 : 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":"2025-11-01","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 : 2025-10-31DOI: 10.1016/j.ahj.2025.107296
Daniël C. Overduin MD , Dirk Jan van Ginkel MD , Christophe Dubois MD, PhD , Pierluigi Lesizza MD , Gijs M. Broeze MSc , Jose M. Montero-Cabezas MD, PhD , Liesbeth Rosseel MD, PhD , Frank van der Kley MD, PhD , Puck JA van Nuland MD , Thijs PM Smits MD , Kimberley I. Hemelrijk MD , Hugo M. Aarts MD , Benno J.W.M. Rensing MD, PhD , Leo Timmers MD, PhD , Martin J. Swaans MD, PhD , Uday Sonker MD , Leo Veenstra MD , Arnoud W.J. van 't Hof MD, PhD , Joyce Peper PhD , Jan G.P. Tijssen PhD , Jurriën M. ten Berg MD, PhD
Background
Unfractionated heparin is routinely used during transcatheter aortic valve implantation (TAVI) to reduce catheter thrombosis and thromboembolism. Protamine reverses the effect of heparin and may lower bleeding risk, but it can also trigger severe allergic reactions. Robust data on the safety and efficacy of routine protamine administration after TAVI is lacking.
Methods
The ``routine versus selective protamine administration to reduce bleeding complications after transcatheter aortic valve implantation (POPular ACE TAVI)'' is an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized clinical trial. A total of 1000 patients will be randomized 1:1 to routine versus selective protamine administration, stratified by study site and antithrombotic therapy. Primary and secondary outcomes are defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. The primary outcome is a composite of all-cause mortality and clinically relevant bleeding (type 1-4) within 30 days after TAVI. Ranked secondary outcomes include clinically relevant bleeding; major, life-threatening or fatal bleeding (type 2-4); major vascular complications; cardiovascular mortality; and all-cause mortality. Safety outcomes include anaphylaxis and thromboembolic events defined as the composite of myocardial infarction, ischemic stroke, transient ischemic attack, or noncerebral distal embolization. Recruitment began in November 2023 and will continue until 1,000 patients are randomized. The trial will end after 30‑day follow‑up of the last patient.
Conclusion
The POPular ACE TAVI trial (NCT05774691) will evaluate whether routine protamine administration reduces all-cause mortality or clinically relevant bleeding after TAVI compared with selective use.
{"title":"Routine versus selective protamine administration to reduce bleeding after TAVI: Rationale and design of the POPular ACE TAVI trial","authors":"Daniël C. Overduin MD , Dirk Jan van Ginkel MD , Christophe Dubois MD, PhD , Pierluigi Lesizza MD , Gijs M. Broeze MSc , Jose M. Montero-Cabezas MD, PhD , Liesbeth Rosseel MD, PhD , Frank van der Kley MD, PhD , Puck JA van Nuland MD , Thijs PM Smits MD , Kimberley I. Hemelrijk MD , Hugo M. Aarts MD , Benno J.W.M. Rensing MD, PhD , Leo Timmers MD, PhD , Martin J. Swaans MD, PhD , Uday Sonker MD , Leo Veenstra MD , Arnoud W.J. van 't Hof MD, PhD , Joyce Peper PhD , Jan G.P. Tijssen PhD , Jurriën M. ten Berg MD, PhD","doi":"10.1016/j.ahj.2025.107296","DOIUrl":"10.1016/j.ahj.2025.107296","url":null,"abstract":"<div><h3>Background</h3><div>Unfractionated heparin is routinely used during transcatheter aortic valve implantation (TAVI) to reduce catheter thrombosis and thromboembolism. Protamine reverses the effect of heparin and may lower bleeding risk, but it can also trigger severe allergic reactions. Robust data on the safety and efficacy of routine protamine administration after TAVI is lacking.</div></div><div><h3>Methods</h3><div>The ``routine versus selective protamine administration to reduce bleeding complications after transcatheter aortic valve implantation (POPular ACE TAVI)'' is an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized clinical trial. A total of 1000 patients will be randomized 1:1 to routine versus selective protamine administration, stratified by study site and antithrombotic therapy. Primary and secondary outcomes are defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. The primary outcome is a composite of all-cause mortality and clinically relevant bleeding (type 1-4) within 30 days after TAVI. Ranked secondary outcomes include clinically relevant bleeding; major, life-threatening or fatal bleeding (type 2-4); major vascular complications; cardiovascular mortality; and all-cause mortality. Safety outcomes include anaphylaxis and thromboembolic events defined as the composite of myocardial infarction, ischemic stroke, transient ischemic attack, or noncerebral distal embolization. Recruitment began in November 2023 and will continue until 1,000 patients are randomized. The trial will end after 30‑day follow‑up of the last patient.</div></div><div><h3>Conclusion</h3><div>The POPular ACE TAVI trial (NCT05774691) will evaluate whether routine protamine administration reduces all-cause mortality or clinically relevant bleeding after TAVI compared with selective use.</div></div><div><h3>Trial registration</h3><div><span><span>clinicaltrials.gov</span><svg><path></path></svg></span>. Unique identifier NCT05774691.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107296"},"PeriodicalIF":3.5,"publicationDate":"2025-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145429951","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 : 2025-10-31DOI: 10.1016/j.ahj.2025.107300
Alexandra B. Steverson MD, MPH , Jun Fan MS , Natasha Din MBBS, MAS , Neil Kalwani MD, MPP , Anubodh S. Varshney MD , Aradhana Verma MD , Hayden B. Bosworth PhD , Tomasz Jurga PharmD , Paul L. Hess MD, MHS , Paul Heidenreich MD, MS , Alexander Sandhu MD, MS
Background
There is a high burden of hospitalizations and deaths annually due to heart failure (HF) in the United States despite effective medical therapy and rural areas may be disproportionately affected. We sought to compare guideline-directed medical therapy (GDMT) utilization between rural and non-rural Veterans with HF with reduced ejection fraction (HFrEF).
Methods
We performed a cross sectional cohort study of Veterans with HFrEF (LVEF ≤ 40%) on January 1, 2022. The VA is an integrated health system with reduced financial barriers, which has a high proportion of rural patients. We compared the frequency of medication fills among rural and non-rural Veterans for renin-angiotensin system inhibitors (RASi), beta-blockers (BB), mineralocorticoid receptor antagonists (MRA) and sodium glucose co-transporter 2 inhibitors (SGLT2i). We used a continuous version of the 4-pillar score (C4P) to assess medical therapy intensity. We used multivariable logistic regression to identify patient characteristics associated with a high C4P score.
Results
Of 65,025 Veterans with HFrEF, 23,728 (36.5%) resided in a rural location, defined as RUCA (Rural–Urban Commuting Areas) code of greater than 1.1. Compared with non-rural, rural Veterans were more frequently White (82.5% vs 63.9%, P < .01) and had a higher burden of comorbidities. Rural Veterans had longer drive times to primary (32 vs 15 minutes, P < .01) and specialty (74 vs 36 minutes, P < .01) care and were less likely to receive VA Cardiology care (44.4% vs 55.8%, P < .01) or care at a high-complexity (level 1a) VA facility (36.4% vs 50.4%, P < .01). Rural Veterans were less frequently prescribed >50% target dose of RASi (19.9% vs 20.2%, P < .01) and BBs (30.9% vs 32.2%, P < .03) and less frequently prescribed SGLT2i (16.3% vs 18.9%, P < .01) and MRA (27.8% vs 28.6%, P < .03) therapy. Rural Veterans were significantly less likely to have a C4P score in the highest decile (OR 0.94, CI: 0.90-0.99) compared with non-rural Veterans.
Conclusion
Rural Veterans with HFrEF were slightly less likely be prescribed comprehensive GDMT. This small difference may be related to gaps in access to VA cardiology and high-complexity facilities. Novel interventions and quality initiatives are needed to decrease disparities in HFrEF care for rural Veterans.
背景：在美国，尽管有有效的药物治疗，但每年因心力衰竭（HF）住院和死亡的负担很高，农村地区可能受到不成比例的影响。我们试图比较农村和非农村HF退伍军人与射血分数降低（HFrEF）之间指导药物治疗（GDMT）的使用情况。方法：我们于2022年1月1日对HFrEF （LVEF≤40%）退伍军人进行横断面队列研究。退伍军人事务部是一个综合卫生系统，其财政障碍较少，农村患者比例很高。我们比较了农村和非农村退伍军人肾素-血管紧张素系统抑制剂（RASi）、β受体阻滞剂（BB）、矿皮质激素受体拮抗剂（MRA）和葡萄糖共转运蛋白2抑制剂（SGLT2i）的用药频率。我们使用连续版的四支柱评分（C4P）来评估药物治疗强度。我们使用多变量逻辑回归来确定与高C4P评分相关的患者特征。结果：65,025名HFrEF退伍军人中，有23,728人（36.5%）居住在农村地区，定义为城乡通勤区（RUCA）代码大于1.1。与非农村退伍军人相比，农村退伍军人在RASi （19.9 vs 20.2%, p < 0.01）和bb （30.9 vs 32.2%, p < 0.01）的靶剂量中White （82.5% vs. 63.9%）和bb （p50%）的发生率更高。这种微小的差异可能与获得VA心脏病学和高复杂性设施的差距有关。需要新的干预措施和质量举措来减少农村退伍军人HFrEF护理的差距。
{"title":"Differences in guideline directed medical therapy for rural and non-rural Veterans with heart failure with reduced ejection fraction","authors":"Alexandra B. Steverson MD, MPH , Jun Fan MS , Natasha Din MBBS, MAS , Neil Kalwani MD, MPP , Anubodh S. Varshney MD , Aradhana Verma MD , Hayden B. Bosworth PhD , Tomasz Jurga PharmD , Paul L. Hess MD, MHS , Paul Heidenreich MD, MS , Alexander Sandhu MD, MS","doi":"10.1016/j.ahj.2025.107300","DOIUrl":"10.1016/j.ahj.2025.107300","url":null,"abstract":"<div><h3>Background</h3><div>There is a high burden of hospitalizations and deaths annually due to heart failure (HF) in the United States despite effective medical therapy and rural areas may be disproportionately affected. We sought to compare guideline-directed medical therapy (GDMT) utilization between rural and non-rural Veterans with HF with reduced ejection fraction (HFrEF).</div></div><div><h3>Methods</h3><div>We performed a cross sectional cohort study of Veterans with HFrEF (LVEF ≤ 40%) on January 1, 2022. The VA is an integrated health system with reduced financial barriers, which has a high proportion of rural patients. We compared the frequency of medication fills among rural and non-rural Veterans for renin-angiotensin system inhibitors (RASi), beta-blockers (BB), mineralocorticoid receptor antagonists (MRA) and sodium glucose co-transporter 2 inhibitors (SGLT2i). We used a continuous version of the 4-pillar score (C4P) to assess medical therapy intensity. We used multivariable logistic regression to identify patient characteristics associated with a high C4P score.</div></div><div><h3>Results</h3><div>Of 65,025 Veterans with HFrEF, 23,728 (36.5%) resided in a rural location, defined as RUCA (Rural–Urban Commuting Areas) code of greater than 1.1. Compared with non-rural, rural Veterans were more frequently White (82.5% vs 63.9%, <em>P</em> < .01) and had a higher burden of comorbidities. Rural Veterans had longer drive times to primary (32 vs 15 minutes, <em>P</em> < .01) and specialty (74 vs 36 minutes, <em>P</em> < .01) care and were less likely to receive VA Cardiology care (44.4% vs 55.8%, <em>P</em> < .01) or care at a high-complexity (level 1a) VA facility (36.4% vs 50.4%, <em>P</em> < .01). Rural Veterans were less frequently prescribed >50% target dose of RASi (19.9% vs 20.2%, <em>P</em> < .01) and BBs (30.9% vs 32.2%, <em>P</em> < .03) and less frequently prescribed SGLT2i (16.3% vs 18.9%, <em>P</em> < .01) and MRA (27.8% vs 28.6%, <em>P</em> < .03) therapy. Rural Veterans were significantly less likely to have a C4P score in the highest decile (OR 0.94, CI: 0.90-0.99) compared with non-rural Veterans.</div></div><div><h3>Conclusion</h3><div>Rural Veterans with HFrEF were slightly less likely be prescribed comprehensive GDMT. This small difference may be related to gaps in access to VA cardiology and high-complexity facilities. Novel interventions and quality initiatives are needed to decrease disparities in HFrEF care for rural Veterans.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107300"},"PeriodicalIF":3.5,"publicationDate":"2025-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145429935","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 : 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":"2025-10-31","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 : 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":"2025-10-27","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 : 2025-10-19DOI: 10.1016/j.ahj.2025.107292
William J. He MD MHS , Brenton R. Prescott MS , Vanessa Xanthakis PhD , Gary F. Mitchell MD , Susan Cheng MD , Ramachandran S. Vasan MD
Background
Previous studies have reported that obesity-related metabolic abnormalities (eg, diabetes and hypertension) lead to myocardial dysfunction and adverse cardiac remodeling. However, it is unclear whether such cardiac remodeling is from obesity or obesity-related metabolic abnormalities. We hypothesize that overweight and obesity are associated with adverse cardiac remodeling independent of associated metabolic abnormalities.
Methods
We evaluated 6,639 participants from the Framingham Heart Study who underwent echocardiography and had no prevalent cardiovascular disease. Individuals were classified into 6 obesity sub-phenotypes based on metabolic health (metabolically healthy or metabolically unhealthy) and body mass index (normal weight, overweight, or obese). Obesity subphenotypes were related to echocardiographic measures using multivariable regression analyses.
Results
Mean age was 49 years and 55% were women. Overweight and obesity were consistently associated with adverse cardiac remodeling in both metabolic healthy and unhealthy participants. Among metabolically healthy participants, compared to the normal weight group (referent), overweight and obesity were significantly associated with increased left ventricular mass (11.6 and 21.4 gm), left atrium end-systolic dimension (0.27 and 0.48 cm), global longitudinal strain (0.82 and 1.06%), and the ratio of early diastolic trans-mitral flow velocity to early diastolic mitral annulus velocity (0.35 and 0.87) (all P < .001). Additionally, obesity was significantly associated with mitral annular plane systolic excursion (0.08 cm, P < .001) and relative wall thickness (0.01, P = .001) compared to the normal weight referent group.
Conclusions
Increasing body weight was associated with adverse cardiac remodeling regardless of metabolic health status, which suggests that obesity may directly increase the risk of adverse cardiac remodeling.
{"title":"Association of obesity subphenotypes with indices of cardiac remodeling in the Framingham heart study","authors":"William J. He MD MHS , Brenton R. Prescott MS , Vanessa Xanthakis PhD , Gary F. Mitchell MD , Susan Cheng MD , Ramachandran S. Vasan MD","doi":"10.1016/j.ahj.2025.107292","DOIUrl":"10.1016/j.ahj.2025.107292","url":null,"abstract":"<div><h3>Background</h3><div>Previous studies have reported that obesity-related metabolic abnormalities (eg, diabetes and hypertension) lead to myocardial dysfunction and adverse cardiac remodeling. However, it is unclear whether such cardiac remodeling is from obesity or obesity-related metabolic abnormalities. We hypothesize that overweight and obesity are associated with adverse cardiac remodeling independent of associated metabolic abnormalities.</div></div><div><h3>Methods</h3><div>We evaluated 6,639 participants from the Framingham Heart Study who underwent echocardiography and had no prevalent cardiovascular disease. Individuals were classified into 6 obesity sub-phenotypes based on metabolic health (metabolically healthy or metabolically unhealthy) and body mass index (normal weight, overweight, or obese). Obesity subphenotypes were related to echocardiographic measures using multivariable regression analyses.</div></div><div><h3>Results</h3><div>Mean age was 49 years and 55% were women. Overweight and obesity were consistently associated with adverse cardiac remodeling in both metabolic healthy and unhealthy participants. Among metabolically healthy participants, compared to the normal weight group (referent), overweight and obesity were significantly associated with increased left ventricular mass (11.6 and 21.4 gm), left atrium end-systolic dimension (0.27 and 0.48 cm), global longitudinal strain (0.82 and 1.06%), and the ratio of early diastolic trans-mitral flow velocity to early diastolic mitral annulus velocity (0.35 and 0.87) (all <em>P</em> < .001). Additionally, obesity was significantly associated with mitral annular plane systolic excursion (0.08 cm, <em>P</em> < .001) and relative wall thickness (0.01, <em>P</em> = .001) compared to the normal weight referent group.</div></div><div><h3>Conclusions</h3><div>Increasing body weight was associated with adverse cardiac remodeling regardless of metabolic health status, which suggests that obesity may directly increase the risk of adverse cardiac remodeling.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107292"},"PeriodicalIF":3.5,"publicationDate":"2025-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145342938","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 : 2025-10-18DOI: 10.1016/j.ahj.2025.107291
Juan F. Iglesias MD , Gregor Leibundgut MD , Dik Heg PhD , Gabriele L. Gasparini MD , Grigorios Tsigkas MD, PhD , Claudiu Ungureanu MD , Giuseppe Colletti MD , Sophie Degrauwe MD , Panagiotis Xaplanteris MD, PhD , Karsten Schenke MD , Alexandru Achim MD , Maarten AH van Leeuwen MD, PhD , Maia Muresan MSc , Shigeru Saito MD , Gregory A. Sgueglia MD, PhD , Adel Aminian MD
Rationale
Distal radial access (DRA) has emerged as a promising alternative to conventional transradial access (TRA) for coronary angiography and percutaneous coronary intervention (PCI). However, existing randomized evidence on DRA primarily involves low-risk patients undergoing diagnostic angiography or noncomplex PCI using ≤6 French (Fr) introducer sheaths. The clinical benefits of DRA among patients undergoing PCI for complex coronary lesions using large-bore guide catheters remain therefore uncertain.
Design
DISCO COMPLEX is an investigator-initiated, prospective, multicenter, international, open-label, randomized, controlled trial with a blinded outcome assessment and superiority design. The trial will compare in a 1:1 ratio large-bore DRA versus conventional TRA using a 7-Fr introducer sheath in 708 patients undergoing PCI for complex coronary lesions (chronic total occlusions, left main disease, heavily calcified lesions, or complex bifurcations) with a 7-Fr guide catheter. The primary hypothesis is that large-bore DRA is superior to conventional TRA with respect to the incidence of forearm radial artery occlusion (RAO) assessed by Doppler ultrasound at hospital discharge. The prespecified DISCOPHILE COMPLEX hand function substudy is a noninferiority trial evaluating whether large-bore DRA is not inferior to conventional TRA with respect to change in full-Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score from baseline to 12 months in participants of the DISCO COMPLEX trial.
Enrolment status
The trial aims to recruit a total of 708 patients from 10 to 15 participating centers across Europe. The first patient was enrolled on August 31, 2023. As of August 20, 2025, 385 patients have been included.
Conclusion
DISCO COMPLEX is the first randomized clinical trial designed to test the superiority of large-bore DRA over conventional TRA in reducing RAO rates among patients undergoing complex PCI with 7-Fr guide catheters.
{"title":"Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial","authors":"Juan F. Iglesias MD , Gregor Leibundgut MD , Dik Heg PhD , Gabriele L. Gasparini MD , Grigorios Tsigkas MD, PhD , Claudiu Ungureanu MD , Giuseppe Colletti MD , Sophie Degrauwe MD , Panagiotis Xaplanteris MD, PhD , Karsten Schenke MD , Alexandru Achim MD , Maarten AH van Leeuwen MD, PhD , Maia Muresan MSc , Shigeru Saito MD , Gregory A. Sgueglia MD, PhD , Adel Aminian MD","doi":"10.1016/j.ahj.2025.107291","DOIUrl":"10.1016/j.ahj.2025.107291","url":null,"abstract":"<div><h3>Rationale</h3><div>Distal radial access (DRA) has emerged as a promising alternative to conventional transradial access (TRA) for coronary angiography and percutaneous coronary intervention (PCI). However, existing randomized evidence on DRA primarily involves low-risk patients undergoing diagnostic angiography or noncomplex PCI using ≤6 French (Fr) introducer sheaths. The clinical benefits of DRA among patients undergoing PCI for complex coronary lesions using large-bore guide catheters remain therefore uncertain.</div></div><div><h3>Design</h3><div>DISCO COMPLEX is an investigator-initiated, prospective, multicenter, international, open-label, randomized, controlled trial with a blinded outcome assessment and superiority design. The trial will compare in a 1:1 ratio large-bore DRA versus conventional TRA using a 7-Fr introducer sheath in 708 patients undergoing PCI for complex coronary lesions (chronic total occlusions, left main disease, heavily calcified lesions, or complex bifurcations) with a 7-Fr guide catheter. The primary hypothesis is that large-bore DRA is superior to conventional TRA with respect to the incidence of forearm radial artery occlusion (RAO) assessed by Doppler ultrasound at hospital discharge. The prespecified DISCOPHILE COMPLEX hand function substudy is a noninferiority trial evaluating whether large-bore DRA is not inferior to conventional TRA with respect to change in full-<em>Disabilities of the Arm, Shoulder and Hand</em> (DASH) questionnaire score from baseline to 12 months in participants of the DISCO COMPLEX trial.</div></div><div><h3>Enrolment status</h3><div>The trial aims to recruit a total of 708 patients from 10 to 15 participating centers across Europe. The first patient was enrolled on August 31, 2023. As of August 20, 2025, 385 patients have been included.</div></div><div><h3>Conclusion</h3><div>DISCO COMPLEX is the first randomized clinical trial designed to test the superiority of large-bore DRA over conventional TRA in reducing RAO rates among patients undergoing complex PCI with 7-Fr guide catheters.</div></div><div><h3>Trial Registration</h3><div>Clinicaltrials.gov: Identifier, NCT05490238.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107291"},"PeriodicalIF":3.5,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336263","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 : 2025-10-17DOI: 10.1016/j.ahj.2025.107290
Linda Ye MD , Michael P. Girouard MD, MBA , Alan S. Go MD , Jane Y. Liu MPH , Rishi V. Parikh MPH , Thida C. Tan MPH , Emily S. Lee MD , Grace Sun BA , Rami Halaseh MD , Ankeet S. Bhatt MD, MBA, ScM , Leonid Pravoverov MD , Sijie Zheng MD , Jana Svetlichnaya MD , Jesse K. Fitzpatrick MD , Harshith R. Avula MD, MPH , Keane K. Lee MD, MS , Sirtaz Adatya MD , David Ouyang MD , Parag Goyal MD, MSc , Alexander T. Sandhu MD, MS , Andrew P. Ambrosy MD, MPH
Background
Chronic kidney disease (CKD) is a major risk factor for heart failure (HF). However, the burden of worsening HF (WHF) events among adults with mild-to-moderate CKD has not been well described.
Objectives
This study assessed the burden of WHF in a contemporary cohort of adults with mild-to-moderate CKD.
Methods
We identified adults with mild-to-moderate CKD (eGFR 30-59 mL/min/1.73m² or eGFR ≥60 mL/min/1.73m² with albuminuria) within a large, integrated healthcare delivery system from 2012 to 2021. Outcomes included hospitalizations, emergency department visits, and outpatient encounters for WHF, stratified by HF status and level of CKD.
Results
Among 375,495 adults with mild-to-moderate CKD, mean age was 64 ± 16 years, 54% were women, mean eGFR was 76 ± 26 mL/min/1.73m², and 6.5% had prior known HF. CKD stages G1A2 (31.6%), G2A2 (24.9%), and G3aA1 (25.1%) were most prevalent. Rates (95% CI) per 100 person-years for WHF events were 1.85 (1.83-1.87) for hospitalizations, 0.85 (0.84-0.86) for emergency department visits, and 0.83 (0.81-0.84) for outpatient encounters, resulting in a cumulative rate of 2.42 (2.40-2.44). Event rates were higher at lower eGFR and higher albuminuria levels.
Conclusions
WHF is a common source of morbidity in adults with earlier stage CKD, and particularly high in those with lower eGFR and greater albuminuria. These findings underscore the importance of implementing available and emerging cardioprotective and renoprotective therapies in this high-risk population.
{"title":"Worsening heart failure events in adults with mild-to-moderate chronic kidney disease","authors":"Linda Ye MD , Michael P. Girouard MD, MBA , Alan S. Go MD , Jane Y. Liu MPH , Rishi V. Parikh MPH , Thida C. Tan MPH , Emily S. Lee MD , Grace Sun BA , Rami Halaseh MD , Ankeet S. Bhatt MD, MBA, ScM , Leonid Pravoverov MD , Sijie Zheng MD , Jana Svetlichnaya MD , Jesse K. Fitzpatrick MD , Harshith R. Avula MD, MPH , Keane K. Lee MD, MS , Sirtaz Adatya MD , David Ouyang MD , Parag Goyal MD, MSc , Alexander T. Sandhu MD, MS , Andrew P. Ambrosy MD, MPH","doi":"10.1016/j.ahj.2025.107290","DOIUrl":"10.1016/j.ahj.2025.107290","url":null,"abstract":"<div><h3>Background</h3><div>Chronic kidney disease (CKD) is a major risk factor for heart failure (HF). However, the burden of worsening HF (WHF) events among adults with mild-to-moderate CKD has not been well described.</div></div><div><h3>Objectives</h3><div>This study assessed the burden of WHF in a contemporary cohort of adults with mild-to-moderate CKD.</div></div><div><h3>Methods</h3><div>We identified adults with mild-to-moderate CKD (eGFR 30-59 mL/min/1.73m² or eGFR ≥60 mL/min/1.73m² with albuminuria) within a large, integrated healthcare delivery system from 2012 to 2021. Outcomes included hospitalizations, emergency department visits, and outpatient encounters for WHF, stratified by HF status and level of CKD.</div></div><div><h3>Results</h3><div>Among 375,495 adults with mild-to-moderate CKD, mean age was 64 ± 16 years, 54% were women, mean eGFR was 76 ± 26 mL/min/1.73m², and 6.5% had prior known HF. CKD stages G1A2 (31.6%), G2A2 (24.9%), and G3aA1 (25.1%) were most prevalent. Rates (95% CI) per 100 person-years for WHF events were 1.85 (1.83-1.87) for hospitalizations, 0.85 (0.84-0.86) for emergency department visits, and 0.83 (0.81-0.84) for outpatient encounters, resulting in a cumulative rate of 2.42 (2.40-2.44). Event rates were higher at lower eGFR and higher albuminuria levels.</div></div><div><h3>Conclusions</h3><div>WHF is a common source of morbidity in adults with earlier stage CKD, and particularly high in those with lower eGFR and greater albuminuria. These findings underscore the importance of implementing available and emerging cardioprotective and renoprotective therapies in this high-risk population.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107290"},"PeriodicalIF":3.5,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145328176","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 : 2025-10-09DOI: 10.1016/j.ahj.2025.107287
Olivia Girolamo BMedSc , Muhammad Dzafir Ismail MBBS, MMed , Rosanna Tavella BSc, PhD , Eng Lee Ooi MBBS, PhD , Sivabaskari Pasupathy BSc, PhD , Sarena La BMedSc , Abdul Sheikh MBBS, MD , Christopher Zeitz MBBS, PhD , John Beltrame BSc, BMBS, PhD
Background
The Coronary Slow Flow Phenomenon (CSFP) is considered a coronary microvascular disorder and has been defined as a corrected thrombolysis in myocardial infarction frame count (cTFC) ≥25 frames. Recent invasive physiology studies have reported that cTFC is not a surrogate marker for coronary microvascular dysfunction (CMD), defined by an abnormal Coronary Flow Reserve (CFR), questioning the integrity of CSFP. This study evaluates the Functional Coronary Angiography (FCA) findings of patients with and without CSFP, as well as the relationship between cTFC and invasive coronary functional measures.
Methods
FCA utilizing a pressure-Doppler flow wire during adenosine infusion, and acetylcholine provocation, was undertaken in 103 patients with angina and non-obstructive coronary artery disease (<50% stenosis; ANOCA).
Results
The FCA findings revealed CMD (i.e. CFR<2) in 43%, inducible coronary artery spasm (58%) and microvascular spasm (13%) in patients with the CSFP (n = 69), which was similar to those without CSFP (n = 34). However, the CSFP patients had a lower resting coronary blood flow velocity (19 ± 7 vs 23 ± 7cm/s, P = .009) with higher resting microvascular resistance (5.8 ± 1.9 vs 4.4 ± 1.7mmHg/cm/s, P = .006) and higher hyperemic microvascular resistance (2.35 ± 1.09 vs 1.94 ± 0.93, P = .049), despite a similar hyperemic CFR (2.25 ± 0.84 vs 2.26 ± 0.58, P = .971) compared to those without CSFP. Furthermore, the cTFC as a continuous measure, correlated with resting coronary blood flow, resting/hyperemic resistance but not CFR.
Conclusion
The conventional marker of CMD (i.e. CFR <2) was similar in patients with/without the CSFP. However alternative hemodynamic markers of impaired coronary microvascular function were abnormal in patients with the CSFP, including resting/hyperemic coronary microvascular resistance. Moreover, cTFC is a simple semi-quantitative marker correlated with coronary microvascular resistance and thus has clinical utility in the diagnosis of the CSFP.
{"title":"Functional coronary angiogram findings in angina with non-obstructive coronary arteries patients with coronary slow flow","authors":"Olivia Girolamo BMedSc , Muhammad Dzafir Ismail MBBS, MMed , Rosanna Tavella BSc, PhD , Eng Lee Ooi MBBS, PhD , Sivabaskari Pasupathy BSc, PhD , Sarena La BMedSc , Abdul Sheikh MBBS, MD , Christopher Zeitz MBBS, PhD , John Beltrame BSc, BMBS, PhD","doi":"10.1016/j.ahj.2025.107287","DOIUrl":"10.1016/j.ahj.2025.107287","url":null,"abstract":"<div><h3>Background</h3><div>The Coronary Slow Flow Phenomenon (CSFP) is considered a coronary microvascular disorder and has been defined as a corrected thrombolysis in myocardial infarction frame count (cTFC) ≥25 frames. Recent invasive physiology studies have reported that cTFC is not a surrogate marker for coronary microvascular dysfunction (CMD), defined by an abnormal Coronary Flow Reserve (CFR), questioning the integrity of CSFP. This study evaluates the Functional Coronary Angiography (FCA) findings of patients with and without CSFP, as well as the relationship between cTFC and invasive coronary functional measures.</div></div><div><h3>Methods</h3><div>FCA utilizing a pressure-Doppler flow wire during adenosine infusion, and acetylcholine provocation, was undertaken in 103 patients with angina and non-obstructive coronary artery disease (<50% stenosis; ANOCA).</div></div><div><h3>Results</h3><div>The FCA findings revealed CMD (i.e. CFR<2) in 43%, inducible coronary artery spasm (58%) and microvascular spasm (13%) in patients with the CSFP (<em>n</em> = 69), which was similar to those without CSFP (<em>n</em> = 34). However, the CSFP patients had a lower resting coronary blood flow velocity (19 ± 7 vs 23 ± 7cm/s, <em>P = .</em>009) with higher resting microvascular resistance (5.8 ± 1.9 vs 4.4 ± 1.7mmHg/cm/s, <em>P = .</em>006) and higher hyperemic microvascular resistance (2.35 ± 1.09 vs 1.94 ± 0.93, <em>P = .</em>049), despite a similar hyperemic CFR (2.25 ± 0.84 vs 2.26 ± 0.58, <em>P = .</em>971) compared to those without CSFP. Furthermore, the cTFC as a continuous measure, correlated with resting coronary blood flow, resting/hyperemic resistance but not CFR.</div></div><div><h3>Conclusion</h3><div>The conventional marker of CMD (i.e. CFR <2) was similar in patients with/without the CSFP. However alternative hemodynamic markers of impaired coronary microvascular function were abnormal in patients with the CSFP, including resting/hyperemic coronary microvascular resistance. Moreover, cTFC is a simple semi-quantitative marker correlated with coronary microvascular resistance and thus has clinical utility in the diagnosis of the CSFP.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"292 ","pages":"Article 107287"},"PeriodicalIF":3.5,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257129","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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