Pub Date : 2024-09-04DOI: 10.1016/j.ahj.2024.07.003
Tomoyuki Kawada MD
{"title":"Blood and urine metal levels in patients with diabetes and cardiovascular disease","authors":"Tomoyuki Kawada MD","doi":"10.1016/j.ahj.2024.07.003","DOIUrl":"10.1016/j.ahj.2024.07.003","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Page 142"},"PeriodicalIF":3.7,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142136320","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 : 2024-09-03DOI: 10.1016/j.ahj.2024.08.014
Sheldon E. Litwin MD , Jan Komtebedde DVM , Barry A. Borlaug MD , David M. Kaye MD, PhD , Gerd Hasenfuβ MD , Rami Kawash MD , Elke Hoendermis MD, PhD , Scott L. Hummel MD , Maja Cikes MD, PhD , Finn Gustafsson MD, PhD , Eugene S. Chung MD , Rajeev C. Mohan MD , Aaron L. Sverdlov MBBS, PhD , Vijendra Swarup MD , Sebastian Winkler MD , Christopher S. Hayward MD , Martin W. Bergmann MD , Heiko Bugger MD , Scott McKenzie MD , Ajith Nair MD , Sanjiv J. Shah MD
Background
There is a little evidence regarding long-term safety and efficacy for atrial shunt devices in heart failure (HF).
Methods
The REDUCE LAP-HF I (n = 44) and II (n = 621) trials (RCT-I and -II) were multicenter, randomized, sham-controlled trials of patients with HF and ejection fraction >40%. Outcome data were analyzed from RCT-I, a mechanistic trial with 5-year follow-up, and RCT-II, a pivotal trial identifying a responder group (n = 313) defined by exercise PVR <1.74 WU and no cardiac rhythm management device with 3-year follow-up.
Results
At 5 years in RCT I, there were no differences in cardiovascular (CV) mortality, HF events, embolic stroke, or new-onset atrial fibrillation between groups. After 3 years in RCT II, there was no difference in the primary outcome (hierarchical composite of CV mortality, stroke, HF events, and KCCQ) between shunt and sham in the overall trial. Compared to sham, those with responder characteristics in RCT-II had a better outcome with shunt (win ratio 1.6 [95% CI 1.2-2.2], P = .006; 44% reduction in HF events [shunt 9 vs. control 16 per 100 patient-years], P = .005; and greater improvement in KCCQ overall summary score [+17.9 ± 20.0 vs. +7.6 ± 20.4], P < .001), while nonresponders had significantly more HF events. Shunt treatment at 3 years was associated with a higher rate of ischemic stroke (3.2% vs. 0%, 95% CI 2%-6.1%, P = .032) and lower incidence of worsening kidney dysfunction (10.7% vs. 19.3%, P = .041).
Conclusions
With up to 5 years of follow up, adverse events were low in patients receiving atrial shunts. In the responder group, atrial shunt treatment was associated with a significantly lower HF event rate and improved KCCQ compared to sham through 3 years of follow-up.
{"title":"Long term safety and outcomes after atrial shunting for heart failure with preserved or mildly reduced ejection fraction: 5-year and 3-year follow-up in the REDUCE LAP-HF I and II trials","authors":"Sheldon E. Litwin MD , Jan Komtebedde DVM , Barry A. Borlaug MD , David M. Kaye MD, PhD , Gerd Hasenfuβ MD , Rami Kawash MD , Elke Hoendermis MD, PhD , Scott L. Hummel MD , Maja Cikes MD, PhD , Finn Gustafsson MD, PhD , Eugene S. Chung MD , Rajeev C. Mohan MD , Aaron L. Sverdlov MBBS, PhD , Vijendra Swarup MD , Sebastian Winkler MD , Christopher S. Hayward MD , Martin W. Bergmann MD , Heiko Bugger MD , Scott McKenzie MD , Ajith Nair MD , Sanjiv J. Shah MD","doi":"10.1016/j.ahj.2024.08.014","DOIUrl":"10.1016/j.ahj.2024.08.014","url":null,"abstract":"<div><h3>Background</h3><div>There is a little evidence regarding long-term safety and efficacy for atrial shunt devices in heart failure (HF).</div></div><div><h3>Methods</h3><div>The REDUCE LAP-HF I (n = 44) and II (n = 621) trials (RCT-I and -II) were multicenter, randomized, sham-controlled trials of patients with HF and ejection fraction >40%. Outcome data were analyzed from RCT-I, a mechanistic trial with 5-year follow-up, and RCT-II, a pivotal trial identifying a responder group (n = 313) defined by exercise PVR <1.74 WU and no cardiac rhythm management device with 3-year follow-up.</div></div><div><h3>Results</h3><div>At 5 years in RCT I, there were no differences in cardiovascular (CV) mortality, HF events, embolic stroke, or new-onset atrial fibrillation between groups. After 3 years in RCT II, there was no difference in the primary outcome (hierarchical composite of CV mortality, stroke, HF events, and KCCQ) between shunt and sham in the overall trial. Compared to sham, those with responder characteristics in RCT-II had a better outcome with shunt (win ratio 1.6 [95% CI 1.2-2.2], <em>P</em> = .006; 44% reduction in HF events [shunt 9 vs. control 16 per 100 patient-years], <em>P</em> = .005; and greater improvement in KCCQ overall summary score [+17.9 ± 20.0 vs. +7.6 ± 20.4], <em>P</em> < .001), while nonresponders had significantly more HF events. Shunt treatment at 3 years was associated with a higher rate of ischemic stroke (3.2% vs. 0%, 95% CI 2%-6.1%, <em>P</em> = .032) and lower incidence of worsening kidney dysfunction (10.7% vs. 19.3%, <em>P</em> = .041).</div></div><div><h3>Conclusions</h3><div>With up to 5 years of follow up, adverse events were low in patients receiving atrial shunts. In the responder group, atrial shunt treatment was associated with a significantly lower HF event rate and improved KCCQ compared to sham through 3 years of follow-up.</div></div><div><h3>Clinicaltrials.gov registration:</h3><div>NCT02600234, NCT03088033.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 106-116"},"PeriodicalIF":3.7,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139056","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 : 2024-09-02DOI: 10.1016/j.ahj.2024.08.020
Eva Havers-Borgersen MD , Christian Jøns MD , Jawad H. Butt MD , Michael Rahbek Schmidt MD, PhD , Klaus Juul MD, PhD , Mathis Gröning MD, PhD , Chee Woon Lim MD , Annette Schophuus Jensen MD, PhD , Morten Smerup MD, PhD , Lars Køber MD, DMSc , Emil L. Fosbøl MD, PhD
Background
As more patients with congenital heart disease (CHD) survive into adulthood, the population of adults with CHD is expanding. This trend is accompanied by an increasing incidence of complications, including arrhythmias. However, the long-term risk of arrhythmias remains sparsely investigated.
Methods
In this observational cohort study, all Danish patients with CHD born from 1977 to 2024 were identified using registries and followed from date of birth until the occurrence of arrhythmia, emigration, death, or end of follow-up (March 2024). The risk of arrhythmias was assessed among patients with CHD and compared to age- and sex-matched controls from the background population.
Results
A total of 45,820 patients with CHD (50.9% men) were identified and matched with 183,280 controls from the background population. During a median follow-up of 21.5 years, 2.6% of patients with CHD and 0.2% of controls developed arrhythmias—corresponding to incidence rates (IR) of 1.2 (95% CI 1.2-1.3) and 0.1 (95% CI 0.1-0.1) per 1,000 PY, respectively, and a hazard ratio (HR) of 16.4 (95% CI 14.4-18.7). The most common arrhythmias in patients with CHD were advanced atrioventricular block (IR 0.4 [95% CI 0.4-0.4] per 1,000 PY) and atrial flutter/fibrillation (IR 0.5 [95% CI 0.5-0.6] per 1,000 PY). Patients with malformations of the heart chambers, transposition of the great arteries, tetralogy of Fallot, and atrioventricular septal defect were at the highest risk of arrhythmias. Moreover, the risk of arrhythmias among those with ASD was not negligible. In patients with CHD, arrhythmia was associated with a significantly higher risk of death (HR of 6.9 [95% CI 5.9-8.1]).
Conclusions
Patients with CHD are at significantly higher risk of arrhythmias than the background population, and those with complex CHD are at particularly high risk. In patients with CHD, arrhythmia is associated with an increased risk of death. Additional studies are warranted to investigate how we can improve the diagnosis and management of arrhythmias in CHD.
{"title":"Arrhythmias in congenital heart disease: A nationwide cohort study","authors":"Eva Havers-Borgersen MD , Christian Jøns MD , Jawad H. Butt MD , Michael Rahbek Schmidt MD, PhD , Klaus Juul MD, PhD , Mathis Gröning MD, PhD , Chee Woon Lim MD , Annette Schophuus Jensen MD, PhD , Morten Smerup MD, PhD , Lars Køber MD, DMSc , Emil L. Fosbøl MD, PhD","doi":"10.1016/j.ahj.2024.08.020","DOIUrl":"10.1016/j.ahj.2024.08.020","url":null,"abstract":"<div><h3>Background</h3><div>As more patients with congenital heart disease (CHD) survive into adulthood, the population of adults with CHD is expanding. This trend is accompanied by an increasing incidence of complications, including arrhythmias. However, the long-term risk of arrhythmias remains sparsely investigated.</div></div><div><h3>Methods</h3><div>In this observational cohort study, all Danish patients with CHD born from 1977 to 2024 were identified using registries and followed from date of birth until the occurrence of arrhythmia, emigration, death, or end of follow-up (March 2024). The risk of arrhythmias was assessed among patients with CHD and compared to age- and sex-matched controls from the background population.</div></div><div><h3>Results</h3><div>A total of 45,820 patients with CHD (50.9% men) were identified and matched with 183,280 controls from the background population. During a median follow-up of 21.5 years, 2.6% of patients with CHD and 0.2% of controls developed arrhythmias—corresponding to incidence rates (IR) of 1.2 (95% CI 1.2-1.3) and 0.1 (95% CI 0.1-0.1) per 1,000 PY, respectively, and a hazard ratio (HR) of 16.4 (95% CI 14.4-18.7). The most common arrhythmias in patients with CHD were advanced atrioventricular block (IR 0.4 [95% CI 0.4-0.4] per 1,000 PY) and atrial flutter/fibrillation (IR 0.5 [95% CI 0.5-0.6] per 1,000 PY). Patients with malformations of the heart chambers, transposition of the great arteries, tetralogy of Fallot, and atrioventricular septal defect were at the highest risk of arrhythmias. Moreover, the risk of arrhythmias among those with ASD was not negligible. In patients with CHD, arrhythmia was associated with a significantly higher risk of death (HR of 6.9 [95% CI 5.9-8.1]).</div></div><div><h3>Conclusions</h3><div>Patients with CHD are at significantly higher risk of arrhythmias than the background population, and those with complex CHD are at particularly high risk. In patients with CHD, arrhythmia is associated with an increased risk of death. Additional studies are warranted to investigate how we can improve the diagnosis and management of arrhythmias in CHD.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 139-149"},"PeriodicalIF":3.7,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142131661","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 : 2024-09-02DOI: 10.1016/j.ahj.2024.08.021
Michael D. Nelson PhD , Joanne M. Gomez-Arnold MD, FACC , Janet Wei MD , Marie Lauzon MS , Sauyeh K. Zamani PhD , Jenna Maughan BA , Okezi Obrutu MD, MPH , Chrisandra Shufelt MD, MS , Eileen Handberg PhD , Carl Pepine MD , C. Noel Bairey Merz MD
Background
There are sex differences in left ventricular ejection fraction (LVEF) relevant to prognosis where women experience greater mortality at relatively higher LVEF compared to men, yet mechanistic understanding of this adverse prognosis is limited. Women with suspected ischemia with no obstructive coronary disease (INOCA) develop heart failure with preserved ejection fraction (HFpEF), yet contributors to LVEF remain largely unknown.
Methods
In 370 women with suspected ischemia with no obstructive coronary disease (INOCA) who prospectively underwent cardiac magnetic resonance imaging (CMRI), we investigated the contributions of LV morphology, function, and myocardial perfusion reserve on LVEF using univariate and multiple linear regression.
Results
A majority 71% of participants had high LVEF (>65%), followed by 24% having normal LVEF (55%-65%), and only 5% having low EF (<55%). Baseline characteristics were comparable among the 3 groups, with the exception of age which was 6 years higher in the high LVEF group (P < .01). Women in the high LVEF group also had the lowest LV cavity volume, greatest LV mass-volume ratio, and highest LV end-systolic elastance (all P < .05, adjusted for age, BMI, diabetes, and blood pressure). Myocardial perfusion reserve index was low in all groups (mean MPRI < 2.1) but was not significantly different across the spectrum of LVEF (P = .458).
Conclusions
Taken together, these data demonstrate that the majority of women with suspected INOCA have elevated LVEF related to smaller, thicker ventricles with greater contractility. Future work is needed to better understand the specific mechanisms driving morphologic and functional changes in women with INOCA, and relations to longer-term HFpEF and mortality.
{"title":"Contributors to high left ventricular ejection fraction in women with ischemia and no obstructive coronary artery disease: Results from the Women's Ischemia Syndrome Evaluation—Coronary Vascular Dysfunction (WISE-CVD) Study","authors":"Michael D. Nelson PhD , Joanne M. Gomez-Arnold MD, FACC , Janet Wei MD , Marie Lauzon MS , Sauyeh K. Zamani PhD , Jenna Maughan BA , Okezi Obrutu MD, MPH , Chrisandra Shufelt MD, MS , Eileen Handberg PhD , Carl Pepine MD , C. Noel Bairey Merz MD","doi":"10.1016/j.ahj.2024.08.021","DOIUrl":"10.1016/j.ahj.2024.08.021","url":null,"abstract":"<div><h3>Background</h3><p>There are sex differences in left ventricular ejection fraction (LVEF) relevant to prognosis where women experience greater mortality at relatively higher LVEF compared to men, yet mechanistic understanding of this adverse prognosis is limited. Women with suspected ischemia with no obstructive coronary disease (INOCA) develop heart failure with preserved ejection fraction (HFpEF), yet contributors to LVEF remain largely unknown.</p></div><div><h3>Methods</h3><p>In 370 women with suspected ischemia with no obstructive coronary disease (INOCA) who prospectively underwent cardiac magnetic resonance imaging (CMRI), we investigated the contributions of LV morphology, function, and myocardial perfusion reserve on LVEF using univariate and multiple linear regression.</p></div><div><h3>Results</h3><p>A majority 71% of participants had high LVEF (>65%), followed by 24% having normal LVEF (55%-65%), and only 5% having low EF (<55%). Baseline characteristics were comparable among the 3 groups, with the exception of age which was 6 years higher in the high LVEF group (<em>P</em> < .01). Women in the high LVEF group also had the lowest LV cavity volume, greatest LV mass-volume ratio, and highest LV end-systolic elastance (all <em>P</em> < .05, adjusted for age, BMI, diabetes, and blood pressure). Myocardial perfusion reserve index was low in all groups (mean MPRI < 2.1) but was not significantly different across the spectrum of LVEF (<em>P</em> = .458).</p></div><div><h3>Conclusions</h3><p>Taken together, these data demonstrate that the majority of women with suspected INOCA have elevated LVEF related to smaller, thicker ventricles with greater contractility. Future work is needed to better understand the specific mechanisms driving morphologic and functional changes in women with INOCA, and relations to longer-term HFpEF and mortality.</p></div><div><h3>Clinical Trials Registration</h3><p>NCT02582021.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 41-47"},"PeriodicalIF":3.7,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324002242/pdfft?md5=1b58237ff566255053b6e76d87df40aa&pid=1-s2.0-S0002870324002242-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142131662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-02DOI: 10.1016/j.ahj.2024.08.022
Emmanuel De Cock MD , Shakeel Kautbally MD, PhD , Frank Timmermans MD, PhD , Kris Bogaerts MSc, PhD , Claude Hanet MD, PhD , Walter Desmet MD, PhD , Olivier Gurné MD, PhD , Pascal Vranckx MD, PhD , Nick Hiltrop MD , Karl Dujardin MD , Philippe Vanduynhoven MD , Paul Vermeersch MD, PhD , Charles Pirlet MD, PhD , Kurt Hermans MD , Bert Van Reet MD , Bert Ferdinande MD , Adel Aminian MD , Willem Dewilde MD, PhD , Antoine Guédès MD, PhD , François Simon MD , Ian Buysschaert MD, PhD
Introduction
Patients with coronary artery disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, cost-efficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease.
Methods
The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronary intervention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months.
Conclusion
The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI. Trial registration: ClinicalTrials.gov: NCT06095765.
{"title":"Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE PCI trial","authors":"Emmanuel De Cock MD , Shakeel Kautbally MD, PhD , Frank Timmermans MD, PhD , Kris Bogaerts MSc, PhD , Claude Hanet MD, PhD , Walter Desmet MD, PhD , Olivier Gurné MD, PhD , Pascal Vranckx MD, PhD , Nick Hiltrop MD , Karl Dujardin MD , Philippe Vanduynhoven MD , Paul Vermeersch MD, PhD , Charles Pirlet MD, PhD , Kurt Hermans MD , Bert Van Reet MD , Bert Ferdinande MD , Adel Aminian MD , Willem Dewilde MD, PhD , Antoine Guédès MD, PhD , François Simon MD , Ian Buysschaert MD, PhD","doi":"10.1016/j.ahj.2024.08.022","DOIUrl":"10.1016/j.ahj.2024.08.022","url":null,"abstract":"<div><h3>Introduction</h3><div>Patients with coronary artery disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, cost-efficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease.</div></div><div><h3>Methods</h3><div>The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronary intervention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months.</div></div><div><h3>Conclusion</h3><div>The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI. Trial registration: ClinicalTrials.gov: <span><span>NCT06095765</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 61-71"},"PeriodicalIF":3.7,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142131663","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 : 2024-08-30DOI: 10.1016/j.ahj.2024.08.016
Sørine Lundberg MD , Pauline Knigge MD , Jarl E. Strange MD, PhD , Nina Nouhravesh MD , Andrea K. Wagner MD, PhD , Mariam E. Malik MD , Jawad H. Butt MD, PhD , Charlotte Andersson MD, PhD , Tor Biering-Sorensen MD, PhD , Gunnar Gislason MD, PhD, Prof , Mark C. Petrie MD, PhD, Prof , John McMurray MD, PhD, Prof , Lars Køber MD, DMSc , Emil L. Fosbol MD, PhD , Morten Schou MD, PhD, Prof
Background
Despite improved survival, hospitalization is still common among patients with heart failure (HF).
Objective
This study aimed to examine temporal trends in infection-related hospitalization among HF patients and compare it to temporal trends in the risk of HF hospitalization and death.
Methods
Using Danish nationwide registers, we included all patients aged 18 to 100 years, with HF diagnosed between January 1, 1997 and December 31, 2017, resulting in a total population of 147.737 patients. The outcomes of interest were primarily infection-related hospitalization and HF hospitalization and secondarily all-cause mortality. The Aalen Johansen's estimator was used to estimate 5-year absolute risks for the primary outcomes. Additionally, cox analysis was used for adjusted analyses.
Results
The population had a median age of 74 [64, 82] years and 57.6 % were males. Patients with HF had a higher risk of infection over time 16.4 % (95% CI 16.0-16.8) in 1997 to 2001 vs 24.5% (95% CI 24.0-24.9) in 2012 to 2017. In contrast, they had a lower risk of HF hospitalization 26.5% (95% CI 26.1-27.0) in 1997 to 2001 vs 23.2% (95% CI 22.8-23.7) in 2012 to 2017. The risk of infection stratified by infection type showed similar trends for all infection types and marked the risk of pneumonia infection as the most significant in all subintervals.
Conclusion
In the period from 1997 to 2017, we observed patients with HF had an increased risk of infection-related hospitalization, driven by pneumonia infections. In contrast, the risk of HF hospitalization decreased over time.
背景：尽管生存率有所提高，但心力衰竭（HF）患者住院治疗的情况仍很普遍：尽管生存率有所提高，但心力衰竭（HF）患者住院治疗仍很常见：本研究旨在探讨心衰患者感染相关住院治疗的时间趋势，并将其与心衰住院和死亡风险的时间趋势进行比较：通过丹麦全国范围内的登记，我们纳入了所有年龄在18-100岁之间、在1997年1月1日至2017年12月31日期间确诊为心房颤动的患者，总人数为147737人。研究结果主要是感染相关住院治疗和心房颤动住院治疗，其次是全因死亡率。Aalen Johansen 估计器用于估计主要结果的五年绝对风险。此外，还采用了 cox 分析法进行调整分析：研究对象的中位年龄为 74 [64, 82] 岁，57.6% 为男性。1997-2001年，高血压患者的感染风险为16.4%（95% CI 16.0-16.8），而2012-2017年为24.5%（95% CI 24.0-24.9）。相比之下，1997-2001年与2012-2017年，他们的心房颤动住院风险分别为26.5%（95% CI 26.1-27.0）和23.2%（95% CI 22.8-23.7）。按感染类型分层的感染风险显示出所有感染类型的相似趋势，并标志着肺炎感染风险在所有子区间内最为显著：1997年至2017年期间，我们观察到，在肺炎感染的驱动下，高血压患者与感染相关的住院风险增加。相比之下，随着时间的推移，心房颤动住院风险有所降低。
{"title":"Temporal trends in infection-related hospitalizations among patients with heart failure: A Danish nationwide study from 1997 to 2017","authors":"Sørine Lundberg MD , Pauline Knigge MD , Jarl E. Strange MD, PhD , Nina Nouhravesh MD , Andrea K. Wagner MD, PhD , Mariam E. Malik MD , Jawad H. Butt MD, PhD , Charlotte Andersson MD, PhD , Tor Biering-Sorensen MD, PhD , Gunnar Gislason MD, PhD, Prof , Mark C. Petrie MD, PhD, Prof , John McMurray MD, PhD, Prof , Lars Køber MD, DMSc , Emil L. Fosbol MD, PhD , Morten Schou MD, PhD, Prof","doi":"10.1016/j.ahj.2024.08.016","DOIUrl":"10.1016/j.ahj.2024.08.016","url":null,"abstract":"<div><h3>Background</h3><div>Despite improved survival, hospitalization is still common among patients with heart failure (HF).</div></div><div><h3>Objective</h3><div>This study aimed to examine temporal trends in infection-related hospitalization among HF patients and compare it to temporal trends in the risk of HF hospitalization and death.</div></div><div><h3>Methods</h3><div>Using Danish nationwide registers, we included all patients aged 18 to 100 years, with HF diagnosed between January 1, 1997 and December 31, 2017, resulting in a total population of 147.737 patients. The outcomes of interest were primarily infection-related hospitalization and HF hospitalization and secondarily all-cause mortality. The Aalen Johansen's estimator was used to estimate 5-year absolute risks for the primary outcomes. Additionally, cox analysis was used for adjusted analyses.</div></div><div><h3>Results</h3><div>The population had a median age of 74 [64, 82] years and 57.6 % were males. Patients with HF had a higher risk of infection over time 16.4 % (95% CI 16.0-16.8) in 1997 to 2001 vs 24.5% (95% CI 24.0-24.9) in 2012 to 2017. In contrast, they had a lower risk of HF hospitalization 26.5% (95% CI 26.1-27.0) in 1997 to 2001 vs 23.2% (95% CI 22.8-23.7) in 2012 to 2017. The risk of infection stratified by infection type showed similar trends for all infection types and marked the risk of pneumonia infection as the most significant in all subintervals.</div></div><div><h3>Conclusion</h3><div>In the period from 1997 to 2017, we observed patients with HF had an increased risk of infection-related hospitalization, driven by pneumonia infections. In contrast, the risk of HF hospitalization decreased over time.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 83-92"},"PeriodicalIF":3.7,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142103702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-30DOI: 10.1016/j.ahj.2024.08.017
Camilla Fuchs Andersen MD , Massar Omar MD, PhD , Julie Hempel Larsen MD , Caroline Kistorp MD, PhD , Christian Tuxen MD, PhD , Finn Gustafsson MD, PhD, DMSc , Lars Køber MD, PhD , Mikael Kjær Poulsen MD, PhD , Jan Christian Brønd PhD , Jacob Eifer Møller MD, PhD, DMSc , Morten Schou MD, PhD , Jesper Jensen MD, PhD
Background
Accelerometer-measured physical activity is an increasingly used endpoint in heart failure (HF) trials. We investigated the determinants of accelerometer-measured physical activity and the relationship with patient-reported health status.
Methods
Post-hoc analysis of the Empire HF trial, including outpatients with HF with reduced ejection fraction (HFrEF). Physical activity was quantified as average accelerometer counts per minute (CPM) with higher values representing higher activity. We investigated associations between activity level and clinical variables, including age, sex, and body mass index, as well as patient-reported health status assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ).
Results
Complete data were available in 180 (95%) patients (86% male, mean age 65 year). Baseline median physical activity level was 1,318 CPM (Q1-Q3 1,111-1,585). Age and anemia were independently associated with activity level (β-coefficients: −10 CPM per year age increase [95% CI −16 to −5.1], P = .00015, and −126 CPM for anemia [95% CI −9.1 to −244], P = .035). Significant independent associations were observed between activity level and all KCCQ summary scores (β-coefficient point estimates of 3.7, 4.6, and 4.9 CPM, all P < .02). For 12-week changes in KCCQ-summary scores, only the KCCQ-CSS was associated with activity level; mean increase of 17.5 CPM [95% CI 1.5 to 34.0], P = 0.032, per 5-point increase in KCCQ-CSS. Associations were not modified by treatment allocation (interaction P-values > .05).
Conclusions
In patients with HFrEF, older age and anemia were independently associated with lower activity. Moreover, physical activity only weakly increased with better health status, suggesting that changes in physical activity reflect improvements in patients’ health status to a limited degree. This highlights the need to better understand the endpoint with regards to all other health parameters to ease interpretation in future HF trials.
{"title":"Accelerometer-measured physical activity in patients with heart failure and reduced ejection fraction: Determinants and relationship with patient-reported health status","authors":"Camilla Fuchs Andersen MD , Massar Omar MD, PhD , Julie Hempel Larsen MD , Caroline Kistorp MD, PhD , Christian Tuxen MD, PhD , Finn Gustafsson MD, PhD, DMSc , Lars Køber MD, PhD , Mikael Kjær Poulsen MD, PhD , Jan Christian Brønd PhD , Jacob Eifer Møller MD, PhD, DMSc , Morten Schou MD, PhD , Jesper Jensen MD, PhD","doi":"10.1016/j.ahj.2024.08.017","DOIUrl":"10.1016/j.ahj.2024.08.017","url":null,"abstract":"<div><h3>Background</h3><p>Accelerometer-measured physical activity is an increasingly used endpoint in heart failure (HF) trials. We investigated the determinants of accelerometer-measured physical activity and the relationship with patient-reported health status.</p></div><div><h3>Methods</h3><p>Post-hoc analysis of the Empire HF trial, including outpatients with HF with reduced ejection fraction (HFrEF). Physical activity was quantified as average accelerometer counts per minute (CPM) with higher values representing higher activity. We investigated associations between activity level and clinical variables, including age, sex, and body mass index, as well as patient-reported health status assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ).</p></div><div><h3>Results</h3><p>Complete data were available in 180 (95%) patients (86% male, mean age 65 year). Baseline median physical activity level was 1,318 CPM (Q1-Q3 1,111-1,585). Age and anemia were independently associated with activity level (β-coefficients: −10 CPM per year age increase [95% CI −16 to −5.1], <em>P</em> = .00015, and −126 CPM for anemia [95% CI −9.1 to −244], <em>P</em> = .035). Significant independent associations were observed between activity level and all KCCQ summary scores (β-coefficient point estimates of 3.7, 4.6, and 4.9 CPM, all <em>P</em> < .02). For 12-week changes in KCCQ-summary scores, only the KCCQ-CSS was associated with activity level; mean increase of 17.5 CPM [95% CI 1.5 to 34.0], <em>P</em> = 0.032, per 5-point increase in KCCQ-CSS. Associations were not modified by treatment allocation (interaction <em>P</em>-values > .05).</p></div><div><h3>Conclusions</h3><p>In patients with HFrEF, older age and anemia were independently associated with lower activity. Moreover, physical activity only weakly increased with better health status, suggesting that changes in physical activity reflect improvements in patients’ health status to a limited degree. This highlights the need to better understand the endpoint with regards to all other health parameters to ease interpretation in future HF trials.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 14-23"},"PeriodicalIF":3.7,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324002205/pdfft?md5=90ab1af541729a5f7e4c80e436878665&pid=1-s2.0-S0002870324002205-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142103690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-29DOI: 10.1016/j.ahj.2024.08.011
Sneha S. Jain MD, MBA , Kenneth W. Mahaffey MD , Karen S. Pieper MS , Wataru Shimizu MD, PhD , Tatjana Potpara MD, PhD , Christian T. Ruff MD, MPH , Hooman Kamel MD, MS , Basil S. Lewis MD , Jan H. Cornel MD , Peter R. Kowey MD , Jay Horrow MD , John Strony MD , Alexei N. Plotnikov MD , Danshi Li MD, PhD , Stephen Weng PhD , Julia Donahue BA , C. Michael Gibson MS, MD , P. Gabriel Steg MD , Roxana Mehran MD , Jeffrey I. Weitz MD , Carolyn S.P. Lam MBBS, PhD
Background
Direct oral anticoagulants are the standard of care for stroke prevention in eligible patients with atrial fibrillation and atrial flutter; however, bleeding remains a significant concern, limiting their use. Milvexian is an oral Factor XIa inhibitor that may offer similar anticoagulant efficacy with less bleeding risk.
Methods
LIBREXIA AF (NCT05757869) is a global phase III, randomized, double-blind, parallel-group, event-driven trial to compare milvexian with apixaban in participants with atrial fibrillation or atrial flutter. Participants are randomly assigned to milvexian 100 mg or apixaban (5 mg or 2.5 mg per label indication) twice daily. The primary efficacy objective is to evaluate if milvexian is noninferior to apixaban for the prevention of stroke and systemic embolism. The principal safety objective is to evaluate if milvexian is superior to apixaban in reducing the endpoint of International Society of Thrombosis and Hemostasis (ISTH) major bleeding events and the composite endpoint of ISTH major and clinically relevant nonmajor (CRNM) bleeding events. In total, 15,500 participants from approximately 1,000 sites in over 30 countries are planned to be enrolled. They will be followed until both 430 primary efficacy outcome events and 530 principal safety events are observed, which is estimated to take approximately 4 years.
Conclusion
The LIBREXIA AF study will determine the efficacy and safety of the oral Factor XIa inhibitor milvexian compared with apixaban in participants with either atrial fibrillation or atrial flutter.
{"title":"Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design","authors":"Sneha S. Jain MD, MBA , Kenneth W. Mahaffey MD , Karen S. Pieper MS , Wataru Shimizu MD, PhD , Tatjana Potpara MD, PhD , Christian T. Ruff MD, MPH , Hooman Kamel MD, MS , Basil S. Lewis MD , Jan H. Cornel MD , Peter R. Kowey MD , Jay Horrow MD , John Strony MD , Alexei N. Plotnikov MD , Danshi Li MD, PhD , Stephen Weng PhD , Julia Donahue BA , C. Michael Gibson MS, MD , P. Gabriel Steg MD , Roxana Mehran MD , Jeffrey I. Weitz MD , Carolyn S.P. Lam MBBS, PhD","doi":"10.1016/j.ahj.2024.08.011","DOIUrl":"10.1016/j.ahj.2024.08.011","url":null,"abstract":"<div><h3>Background</h3><p>Direct oral anticoagulants are the standard of care for stroke prevention in eligible patients with atrial fibrillation and atrial flutter; however, bleeding remains a significant concern, limiting their use. Milvexian is an oral Factor XIa inhibitor that may offer similar anticoagulant efficacy with less bleeding risk.</p></div><div><h3>Methods</h3><p>LIBREXIA AF (NCT05757869) is a global phase III, randomized, double-blind, parallel-group, event-driven trial to compare milvexian with apixaban in participants with atrial fibrillation or atrial flutter. Participants are randomly assigned to milvexian 100 mg or apixaban (5 mg or 2.5 mg per label indication) twice daily. The primary efficacy objective is to evaluate if milvexian is noninferior to apixaban for the prevention of stroke and systemic embolism. The principal safety objective is to evaluate if milvexian is superior to apixaban in reducing the endpoint of International Society of Thrombosis and Hemostasis (ISTH) major bleeding events and the composite endpoint of ISTH major and clinically relevant nonmajor (CRNM) bleeding events. In total, 15,500 participants from approximately 1,000 sites in over 30 countries are planned to be enrolled. They will be followed until both 430 primary efficacy outcome events and 530 principal safety events are observed, which is estimated to take approximately 4 years.</p></div><div><h3>Conclusion</h3><p>The LIBREXIA AF study will determine the efficacy and safety of the oral Factor XIa inhibitor milvexian compared with apixaban in participants with either atrial fibrillation or atrial flutter.</p></div><div><h3>Trial registration</h3><p>ClinicalTrials.gov NCT05757869</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 145-158"},"PeriodicalIF":3.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324002060/pdfft?md5=9d5dedf46b35a702a85245f6480f289f&pid=1-s2.0-S0002870324002060-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142103692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-29DOI: 10.1016/j.ahj.2024.08.009
Chan Woo Kim MD , Mohammed Haji MD , Vrishali V. Lopes MS , Christopher Halladay MS , Jennifer L. Sullivan PhD , David Ross MD , Karen Slazinski PharmD , Tracey H. Taveira PharmD , Anupama Menon MD , Melissa Gaitanis MD , Christopher T. Longenecker MD , Gerald S. Bloomfield MD , James L Rudolph MD, SM , Wen-Chih Wu MD, MPH , Sebhat Erqou MD, PhD
Background
Hypertension is a leading risk factor for cardiovascular disease among patients living with HIV (PLWH). Understanding the predictors and patterns of antihypertensive medication prescription and blood pressure (BP) control among PLWH with hypertension (HTN) is important to improve the primary prevention efforts for this high-risk population. We sought to assess important patient-level correlates (eg, race) and inter-facility variations in antihypertension medication prescriptions and BP control among Veterans living with HIV (VLWH) and HTN.
Methods
We studied VLWH with a diagnosis of HTN who received care in the Veterans Health Administration (VHA) from January 2018 to December 2019. We evaluated HTN treatment and blood pressure control across demographic variables, including race, and by medical comorbidities. Data were also compared among VHA facilities. Predictors of HTN treatment and control were assessed in 2-level hierarchical multivariate logistic regression models to estimate odds ratios (ORs). The VHA facility random-effects parameters from the hierarchical models were used to calculate the median odds ratios to characterize the variation across the different VHA facilities.
Results
A total of 17,468 VLWH with HTN (mean age 61 years, 97% male, 54% Black, 40% White) who received care within the VHA facilities in 2018-2019 were included. 73% were prescribed antihypertension medications with higher prescription rates among Black vs White patients (75% vs 71%) and higher prescription rates among patients with a history of cardiovascular disease, diabetes, and kidney disease (>80%), and those receiving antiretroviral therapy and with controlled HIV viral load (∼75%). Only 27% of VLWH with HTN had optimal BP control of systolic BP <130 mmHg and diastolic BP <80 mmHg, with a lower rate of control among Black vs White patients (24% v. 31%). In multivariate regression, Black patients had a higher likelihood of HTN medication prescription (OR 1.32, 95% CI: 1.22-1.42) but were less likely to have optimal BP control (OR 0.82; 0.76-0.88). Important positive correlates of antihypertensive prescription and optimal BP control included: number of outpatient visits in prior year, and histories of diabetes, coronary artery disease, and heart failure. There was about 10% variability in both antihypertensive prescription and BP control patterns between VHA facilities for patients with similar characteristics. There was increased inter-facility variation in antihypertensive prescription among those with a history of heart failure and those not receiving antiretroviral therapy.
Conclusion
In a retrospective analysis of large VHA data, we found that VLWH with HTN have suboptimal antihypertensive medication prescription and BP control. Black VLWH had higher HTN medication prescription rates but lower optimal BP control.
{"title":"Variations in antihypertensive medication treatment and blood pressure control among Veterans with HIV and existing hypertension","authors":"Chan Woo Kim MD , Mohammed Haji MD , Vrishali V. Lopes MS , Christopher Halladay MS , Jennifer L. Sullivan PhD , David Ross MD , Karen Slazinski PharmD , Tracey H. Taveira PharmD , Anupama Menon MD , Melissa Gaitanis MD , Christopher T. Longenecker MD , Gerald S. Bloomfield MD , James L Rudolph MD, SM , Wen-Chih Wu MD, MPH , Sebhat Erqou MD, PhD","doi":"10.1016/j.ahj.2024.08.009","DOIUrl":"10.1016/j.ahj.2024.08.009","url":null,"abstract":"<div><h3>Background</h3><div>Hypertension is a leading risk factor for cardiovascular disease among patients living with HIV (PLWH). Understanding the predictors and patterns of antihypertensive medication prescription and blood pressure (BP) control among PLWH with hypertension (HTN) is important to improve the primary prevention efforts for this high-risk population. We sought to assess important patient-level correlates (eg, race) and inter-facility variations in antihypertension medication prescriptions and BP control among Veterans living with HIV (VLWH) and HTN.</div></div><div><h3>Methods</h3><div>We studied VLWH with a diagnosis of HTN who received care in the Veterans Health Administration (VHA) from January 2018 to December 2019. We evaluated HTN treatment and blood pressure control across demographic variables, including race, and by medical comorbidities. Data were also compared among VHA facilities. Predictors of HTN treatment and control were assessed in 2-level hierarchical multivariate logistic regression models to estimate odds ratios (ORs). The VHA facility random-effects parameters from the hierarchical models were used to calculate the median odds ratios to characterize the variation across the different VHA facilities.</div></div><div><h3>Results</h3><div>A total of 17,468 VLWH with HTN (mean age 61 years, 97% male, 54% Black, 40% White) who received care within the VHA facilities in 2018-2019 were included. 73% were prescribed antihypertension medications with higher prescription rates among Black vs White patients (75% vs 71%) and higher prescription rates among patients with a history of cardiovascular disease, diabetes, and kidney disease (>80%), and those receiving antiretroviral therapy and with controlled HIV viral load (∼75%). Only 27% of VLWH with HTN had optimal BP control of systolic BP <130 mmHg and diastolic BP <80 mmHg, with a lower rate of control among Black vs White patients (24% v. 31%). In multivariate regression, Black patients had a higher likelihood of HTN medication prescription (OR 1.32, 95% CI: 1.22-1.42) but were less likely to have optimal BP control (OR 0.82; 0.76-0.88). Important positive correlates of antihypertensive prescription and optimal BP control included: number of outpatient visits in prior year, and histories of diabetes, coronary artery disease, and heart failure. There was about 10% variability in both antihypertensive prescription and BP control patterns between VHA facilities for patients with similar characteristics. There was increased inter-facility variation in antihypertensive prescription among those with a history of heart failure and those not receiving antiretroviral therapy.</div></div><div><h3>Conclusion</h3><div>In a retrospective analysis of large VHA data, we found that VLWH with HTN have suboptimal antihypertensive medication prescription and BP control. Black VLWH had higher HTN medication prescription rates but lower optimal BP control.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 48-60"},"PeriodicalIF":3.7,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142103703","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 : 2024-08-27DOI: 10.1016/j.ahj.2024.08.018
Giuseppe D. Sanna MD, PhD , Gian Luca Erre MD, PhD , Matteo Cameli MD, PhD , Federico Guerra MD, PhD , Maria Concetta Pastore MD , Alessandro Marini MD , Alessandro Campora MD , Pierpaolo Gironella MD , Mario Costamagna MD , Giulia Elena Mandoli MD, PhD , Mirko Casiraghi MD , Angelo Scuteri MD, PhD , Matteo Lisi MD , Gavino Casu MD , Martino Deidda MD, PhD , Christian Cadeddu Dessalvi MD, PhD , REAL-HF investigators
Background
There are sex differences in HF patients. It is not clear whether such differences mainly reflect cultural behaviours and clinical inertia, and the role of sex on clinical outcomes is still controversial. We aimed to investigate the association of sex with in-hospital management and outcomes in patients with HF.
Methods
We analyzed data of 4016 adult patients hospitalized for HF in 2020 to 2021 and enrolled in a multicentre national registry.
Results
Women (n = 1,818 [45%]) were older than men (83 vs 77 years, P < .0001), with a higher prevalence of arterial hypertension (73% vs 69%, P = .011) and atrial fibrillation. Women presented more frequently with HF and preserved ejection fraction -HFpEF (55% vs 32%, P < .001). They were more often hospitalized in internal medicine departments (71% vs 51%), and men in highly specialized cardiology units (49% vs 29%). When considering HF pharmacological treatments at discharge in the subgroup with reduced ejection fraction -HFrEF (n=1525), there were no significant differences (49% of women treated with GDMT [guideline-directed medical therapy] vs 52% of men, P = .197). Sex was not associated either with hospital readmissions (30-days OR [95% CI] = 0.89 [0.71-1.11], P = .304; 1-year OR [95% CI] = 1.02[0.88-1.19], P = .777) or with mortality (in-hospital OR [95% CI] = 1.14 [0.73-1.78], P = .558; 1-year OR [95% CI] = 1.08 [0.87-1.33], P = .478). Similar results were obtained when considering different HF categories based on left ventricular ejection fraction.
Conclusions
Women and men exhibited distinct clinical profiles. Although this may have had an impact on hospital pathways (noncardiology/cardiology units) and pharmacological prescriptions, sex per se did not appear as an independent determinant of clinical choices. Moreover, when considering homogeneous groups, women were not undertreated. Finally, female sex was not associated with worse clinical outcomes.
{"title":"Association of sex with in-hospital management and outcomes of patients with heart failure: Data from the REAL-HF registry","authors":"Giuseppe D. Sanna MD, PhD , Gian Luca Erre MD, PhD , Matteo Cameli MD, PhD , Federico Guerra MD, PhD , Maria Concetta Pastore MD , Alessandro Marini MD , Alessandro Campora MD , Pierpaolo Gironella MD , Mario Costamagna MD , Giulia Elena Mandoli MD, PhD , Mirko Casiraghi MD , Angelo Scuteri MD, PhD , Matteo Lisi MD , Gavino Casu MD , Martino Deidda MD, PhD , Christian Cadeddu Dessalvi MD, PhD , REAL-HF investigators","doi":"10.1016/j.ahj.2024.08.018","DOIUrl":"10.1016/j.ahj.2024.08.018","url":null,"abstract":"<div><h3>Background</h3><div>There are sex differences in HF patients. It is not clear whether such differences mainly reflect cultural behaviours and clinical inertia, and the role of sex on clinical outcomes is still controversial. We aimed to investigate the association of sex with in-hospital management and outcomes in patients with HF.</div></div><div><h3>Methods</h3><div>We analyzed data of 4016 adult patients hospitalized for HF in 2020 to 2021 and enrolled in a multicentre national registry.</div></div><div><h3>Results</h3><div>Women (n = 1,818 [45%]) were older than men (83 <em>vs</em> 77 years, <em>P</em> < .0001), with a higher prevalence of arterial hypertension (73% <em>vs</em> 69%, <em>P</em> = .011) and atrial fibrillation. Women presented more frequently with HF and preserved ejection fraction -HFpEF (55% <em>vs</em> 32%, <em>P</em> < .001). They were more often hospitalized in internal medicine departments (71% <em>vs</em> 51%), and men in highly specialized cardiology units (49% <em>vs</em> 29%). When considering HF pharmacological treatments at discharge in the subgroup with reduced ejection fraction -HFrEF (n=1525), there were no significant differences (49% of women treated with GDMT [guideline-directed medical therapy] <em>vs</em> 52% of men, <em>P</em> = .197). Sex was not associated either with hospital readmissions (30-days OR [95% CI] = 0.89 [0.71-1.11], <em>P</em> = .304; 1-year OR [95% CI] = 1.02[0.88-1.19], <em>P</em> = .777) or with mortality (in-hospital OR [95% CI] = 1.14 [0.73-1.78], <em>P</em> = .558; 1-year OR [95% CI] = 1.08 [0.87-1.33], <em>P</em> = .478). Similar results were obtained when considering different HF categories based on left ventricular ejection fraction.</div></div><div><h3>Conclusions</h3><div>Women and men exhibited distinct clinical profiles. Although this may have had an impact on hospital pathways (noncardiology/cardiology units) and pharmacological prescriptions, sex <em>per se</em> did not appear as an independent determinant of clinical choices. Moreover, when considering homogeneous groups, women were not undertreated. Finally, female sex was not associated with worse clinical outcomes.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 72-82"},"PeriodicalIF":3.7,"publicationDate":"2024-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142103691","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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