1,986 results
Search Results
2. The Early Repolarization Pattern: A Consensus Paper.
- Author
-
Macfarlane PW, Antzelevitch C, Haissaguerre M, Huikuri HV, Potse M, Rosso R, Sacher F, Tikkanen JT, Wellens H, and Yan GX
- Subjects
- Heart Conduction System physiopathology, Humans, Electrocardiography, Ventricular Fibrillation diagnosis, Ventricular Fibrillation physiopathology
- Abstract
The term early repolarization has been in use for more than 50 years. This electrocardiographic pattern was considered benign until 2008, when it was linked to sudden cardiac arrest due to idiopathic ventricular fibrillation. Much confusion over the definition of early repolarization followed. Thus, the objective of this paper was to prepare an agreed definition to facilitate future research in this area. The different definitions of the early repolarization pattern were reviewed to delineate the electrocardiographic measures to be used when defining this pattern. An agreed definition has been established, which requires the peak of an end-QRS notch and/or the onset of an end-QRS slur as a measure, denoted Jp, to be determined when an interpretation of early repolarization is being considered. One condition for early repolarization to be present is Jp ≥0.1 mV, while ST-segment elevation is not a required criterion., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2015
- Full Text
- View/download PDF
3. Aspirin therapy in primary cardiovascular disease prevention: a position paper of the European Society of Cardiology working group on thrombosis.
- Author
-
Halvorsen S, Andreotti F, ten Berg JM, Cattaneo M, Coccheri S, Marchioli R, Morais J, Verheugt FW, and De Caterina R
- Subjects
- Cardiology trends, Cardiovascular Diseases diagnosis, Cardiovascular Diseases epidemiology, Europe epidemiology, Humans, Primary Prevention trends, Societies, Medical trends, Thrombosis diagnosis, Aspirin administration & dosage, Cardiology standards, Cardiovascular Diseases prevention & control, Primary Prevention standards, Societies, Medical standards, Thrombosis prevention & control
- Abstract
Although the use of oral anticoagulants (vitamin K antagonists) has been abandoned in primary cardiovascular prevention due to lack of a favorable benefit-to-risk ratio, the indications for aspirin use in this setting continue to be a source of major debate, with major international guidelines providing conflicting recommendations. Here, we review the evidence in favor and against aspirin therapy in primary prevention based on the evidence accumulated so far, including recent data linking aspirin with cancer protection. While awaiting the results of several ongoing studies, we argue for a pragmatic approach to using low-dose aspirin in primary cardiovascular prevention and suggest its use in patients at high cardiovascular risk, defined as ≥2 major cardiovascular events (death, myocardial infarction, or stroke) projected per 100 person-years, who are not at increased risk of bleeding., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2014
- Full Text
- View/download PDF
4. When abstracts conflict with published papers.
- Author
-
DeMaria AN
- Subjects
- Editorial Policies, Humans, Publication Bias, Biomedical Research standards, Periodicals as Topic standards
- Published
- 2013
- Full Text
- View/download PDF
5. New oral anticoagulants in atrial fibrillation and acute coronary syndromes: ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease position paper.
- Author
-
De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, and Weitz JI
- Subjects
- Acute Coronary Syndrome complications, Administration, Oral, Atrial Fibrillation complications, Heart Diseases drug therapy, Humans, Thrombosis etiology, Acute Coronary Syndrome drug therapy, Advisory Committees, Anticoagulants administration & dosage, Atrial Fibrillation drug therapy, Periodicals as Topic, Societies, Medical, Thrombosis prevention & control
- Abstract
Until recently, vitamin K antagonists were the only available oral anticoagulants, but with numerous limitations that prompted the introduction of new oral anticoagulants targeting the single coagulation enzymes thrombin (dabigatran) or factor Xa (apixaban, rivaroxaban, and edoxaban) and given in fixed doses without coagulation monitoring. Here we review the pharmacology and the results of clinical trials with these new agents in stroke prevention in atrial fibrillation and secondary prevention after acute coronary syndromes, providing perspectives on their future incorporation into clinical practice. In phase III trials in atrial fibrillation, compared with warfarin, dabigatran etexilate 150 mg B.I.D. reduced the rates of stroke/systemic embolism without any difference in major bleeding; dabigatran etexilate 110 mg B.I.D. had similar efficacy with decreased bleeding; apixaban 5 mg B.I.D. reduced stroke, systemic embolism, and mortality as well as major bleeding; and rivaroxaban 20 mg Q.D. was noninferior to warfarin for stroke and systemic embolism without a difference in major bleeding. All these agents reduced intracranial hemorrhage. Edoxaban is currently being evaluated in a further large phase III trial. Apixaban and rivaroxaban were evaluated in phase III trials for prevention of recurrent ischemia in patients with acute coronary syndromes who were mostly receiving dual antiplatelet therapy, with conflicting results on efficacy but consistent results for increased major bleeding. Overall, the new oral anticoagulants are poised to replace vitamin K antagonists for many patients with atrial fibrillation and may have a role after acute coronary syndromes. Although convenient to administer and manage, they present challenges that need to be addressed., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2012
- Full Text
- View/download PDF
6. Research recommendations during the writing of white papers.
- Author
-
Silverstein HR and Guy JT
- Subjects
- Writing, Research
- Published
- 2010
- Full Text
- View/download PDF
7. Cardiovascular magnetic resonance in myocarditis: A JACC White Paper.
- Author
-
Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, and Liu P
- Subjects
- Canada epidemiology, Consensus, Humans, Inflammation epidemiology, Inflammation physiopathology, Models, Cardiovascular, Myocarditis epidemiology, Myocarditis etiology, Myocarditis physiopathology, Risk Factors, Societies, Medical, Magnetic Resonance Angiography methods, Myocarditis diagnosis, Myocardium pathology
- Abstract
Cardiovascular magnetic resonance (CMR) has become the primary tool for noninvasive assessment of myocardial inflammation in patients with suspected myocarditis. The International Consensus Group on CMR Diagnosis of Myocarditis was founded in 2006 to achieve consensus among CMR experts and develop recommendations on the current state-of-the-art use of CMR for myocarditis. The recommendations include indications for CMR in patients with suspected myocarditis, CMR protocol standards, terminology for reporting CMR findings, and diagnostic CMR criteria for myocarditis (i.e., "Lake Louise Criteria").
- Published
- 2009
- Full Text
- View/download PDF
8. How do I get a paper accepted? Concerns of a junior researcher.
- Author
-
Karamitsos TD
- Subjects
- Bias, Data Interpretation, Statistical, Humans, Editorial Policies, Periodicals as Topic
- Published
- 2007
- Full Text
- View/download PDF
9. How do I get a paper accepted?--Part 2.
- Author
-
DeMaria AN
- Subjects
- Humans, Editorial Policies, Periodicals as Topic
- Published
- 2007
- Full Text
- View/download PDF
10. How do I get a paper accepted?
- Author
-
DeMaria AN
- Subjects
- Humans, Peer Review, Research, Quality Control, United States, Editorial Policies, Journalism, Medical standards, Periodicals as Topic standards
- Published
- 2007
- Full Text
- View/download PDF
11. Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an International Forum on Cardiac Remodeling.
- Author
-
Cohn JN, Ferrari R, and Sharpe N
- Subjects
- Adrenergic beta-Antagonists therapeutic use, Angiotensin-Converting Enzyme Inhibitors therapeutic use, Apoptosis, Cardiotonic Agents therapeutic use, Cell Division, Disease Progression, Echocardiography, Heart Failure diagnosis, Heart Failure drug therapy, Heart Ventricles drug effects, Heart Ventricles pathology, Humans, Radionuclide Ventriculography, Stroke Volume drug effects, Treatment Outcome, Heart Failure physiopathology, Heart Ventricles physiopathology, Ventricular Remodeling
- Abstract
Cardiac remodeling is generally accepted as a determinant of the clinical course of heart failure (HF). Defined as genome expression resulting in molecular, cellular and interstitial changes and manifested clinically as changes in size, shape and function of the heart resulting from cardiac load or injury, cardiac remodeling is influenced by hemodynamic load, neurohormonal activation and other factors still under investigation. Although patients with major remodeling demonstrate progressive worsening of cardiac function, slowing or reversing remodeling has only recently become a goal of HF therapy. Mechanisms other than remodeling can also influence the course of heart disease, and disease progression may occur in other ways in the absence of cardiac remodeling. Left ventricular end-diastolic and end-systolic volume and ejection fraction data provide support for the beneficial effects of therapeutic agents such as angiotensin-converting enzyme (ACE) inhibitors and beta-adrenergic blocking agents on the remodeling process. These agents also provide benefits in terms of morbidity and mortality. Although measurement of ejection fraction can reliably guide initiation of treatment in HF, opinions differ regarding the value of ejection fraction data in guiding ongoing therapy. The role of echocardiography or radionuclide imaging in the management and monitoring of HF is as yet unclear. To fully appreciate the potential benefits of HF therapies, clinicians should understand the relationship between remodeling and HF progression. Their patients may then, in turn, acquire an improved understanding of their disease and the treatments they are given.
- Published
- 2000
- Full Text
- View/download PDF
12. Seminar on small coronary artery disease: structure and function of small coronary arteries in health and disease--I. Based on papers presented by the WHO/ISFC Task Force. Geneva, Switzerland, June 12, 1989.
- Subjects
- Animals, Humans, Coronary Disease physiopathology, Coronary Vessels physiology
- Published
- 1990
13. Abstracts of papers to be presented at the 32nd annual scientific session of the American College of Cardiology. New Orleans, Louisiana, March 20-24, 1983.
- Subjects
- Animals, Humans, Heart Diseases
- Published
- 1983
- Full Text
- View/download PDF
14. Abstracts of papers. 38th annual scientific session of the American College of Cardiology. Anaheim, California, March 19-23, 1989.
- Subjects
- Animals, Humans, Heart physiology, Heart Diseases
- Published
- 1989
15. Abstracts of papers to be presented at the 33rd annual scientific session of the American College of Cardiology. Dallas, Texas, March 25-29, 1984.
- Subjects
- Animals, Humans, Heart Diseases
- Published
- 1984
- Full Text
- View/download PDF
16. The continuing problem of retracted papers.
- Author
-
Dack S
- Subjects
- United States, Cardiology, Publishing, Retraction of Publication as Topic
- Published
- 1986
- Full Text
- View/download PDF
17. Abstracts of papers to be presented at the 34th Annual Scientific Session of the American College of Cardiology, Anaheim, California, March 10-14, 1985.
- Subjects
- Humans, Heart Diseases
- Published
- 1985
- Full Text
- View/download PDF
18. Retraction of two additional papers by Robert A. Slutsky, M.D.
- Published
- 1987
- Full Text
- View/download PDF
19. The Role of Nutraceuticals in Statin Intolerant Patients.
- Author
-
Banach M, Patti AM, Giglio RV, Cicero AFG, Atanasov AG, Bajraktari G, Bruckert E, Descamps O, Djuric DM, Ezhov M, Fras Z, von Haehling S, Katsiki N, Langlois M, Latkovskis G, Mancini GBJ, Mikhailidis DP, Mitchenko O, Moriarty PM, Muntner P, Nikolic D, Panagiotakos DB, Paragh G, Paulweber B, Pella D, Pitsavos C, Reiner Ž, Rosano GMC, Rosenson RS, Rysz J, Sahebkar A, Serban MC, Vinereanu D, Vrablík M, Watts GF, Wong ND, and Rizzo M
- Subjects
- Clinical Studies as Topic, Dyslipidemias diet therapy, Humans, Dietary Supplements, Dyslipidemias drug therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects
- Abstract
Statins are the most common drugs administered for patients with cardiovascular disease. However, due to statin-associated muscle symptoms, adherence to statin therapy is challenging in clinical practice. Certain nutraceuticals, such as red yeast rice, bergamot, berberine, artichoke, soluble fiber, and plant sterols and stanols alone or in combination with each other, as well as with ezetimibe, might be considered as an alternative or add-on therapy to statins, although there is still insufficient evidence available with respect to long-term safety and effectiveness on cardiovascular disease prevention and treatment. These nutraceuticals could exert significant lipid-lowering activity and might present multiple non-lipid-lowering actions, including improvement of endothelial dysfunction and arterial stiffness, as well as anti-inflammatory and antioxidative properties. The aim of this expert opinion paper is to provide the first attempt at recommendation on the management of statin intolerance through the use of nutraceuticals with particular attention on those with effective low-density lipoprotein cholesterol reduction., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
- Full Text
- View/download PDF
20. Lone atrial fibrillation: does it exist?
- Author
-
Wyse DG, Van Gelder IC, Ellinor PT, Go AS, Kalman JM, Narayan SM, Nattel S, Schotten U, and Rienstra M
- Subjects
- Age Factors, Disease Progression, Global Health, Humans, Incidence, Risk Factors, Atrial Fibrillation etiology, Atrial Fibrillation physiopathology, Atrial Fibrillation therapy, Cardiac Resynchronization Therapy methods, Heart Conduction System physiopathology, Heart Diseases complications
- Abstract
The historical origin of the term "lone atrial fibrillation" (AF) predates by 60 years our current understanding of the pathophysiology of AF, the multitude of known etiologies for AF, and our ability to image and diagnose heart disease. The term was meant to indicate AF in patients for whom subsequent investigations could not demonstrate heart disease, but for many practitioners has become synonymous with "idiopathic AF." As the list of heart diseases has expanded and diagnostic techniques have improved, the prevalence of lone AF has fallen. The legacy of the intervening years is that definitions of lone AF in the literature are inconsistent so that studies of lone AF are not comparable. Guidelines provide a vague definition of lone AF but do not provide direction about how much or what kind of imaging and other testing are necessary to exclude heart disease. There has been an explosion in the understanding of the pathophysiology of AF in the last 20 years in particular. Nevertheless, there are no apparently unique mechanisms for AF in patients categorized as having lone AF. In addition, the term "lone AF" is not invariably useful in making treatment decisions, and other tools for doing so have been more thoroughly and carefully validated. It is, therefore, recommended that use of the term "lone AF" be avoided., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2014
- Full Text
- View/download PDF
21. Acute Respiratory Infections Fuel Cardiovascular Disease.
- Author
-
van Royen FS, Venekamp RP, Bruijning-Verhagen PCJL, and Rutten FH
- Abstract
Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
22. Congenitally Corrected Transposition of the Great Arteries: The Impact of Anatomic vs Physiologic Repair.
- Author
-
Karamlou T and Robinson J
- Abstract
Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
23. Anatomic and Physiologic Repair of Congenitally Corrected Transposition of the Great Arteries.
- Author
-
Jacob KA, Hörer J, Hraska V, Agbor VN, Duchateau S, van Wijk A, Barron DJ, and Schoof PH
- Subjects
- Humans, Cardiac Surgical Procedures methods, Congenitally Corrected Transposition of the Great Arteries, Transposition of Great Vessels surgery, Transposition of Great Vessels physiopathology
- Abstract
Background: Congenitally corrected transposition of the great arteries (ccTGA) is a rare cardiac anomaly. The management strategy historically consisted of physiologic repair, leaving the morphologic right ventricle to support the systemic circulation. More recently, anatomic repair has been implemented to bring the left ventricle into the systemic circulation. Uncertainty persists about which repair strategy has the best outcome., Objectives: This meta-analysis aimed to summarize the long-term mortality risks following anatomic and physiologic repair of ccTGA., Methods: PubMed, Embase, and the Cochrane Database were searched. Data were extracted using prespecified data forms. The primary outcome was the composite risk of all-cause mortality or heart transplantation during hospitalization and at 1, 5, and 10 years of follow-up. Secondary outcomes included reintervention risk., Results: Forty-seven studies totaling 2,844 patients were included. The incidence risk of mortality at 10 years was 11.7% (95% CI: 8.5%-15.3%) and 17.4% (95% CI: 12.4%-23.0%) in the anatomic and physiologic repair groups, respectively. The incidence risk of reintervention at 10 years was 24.5% (95% CI: 19.2%-30.1%) and 30.3% (95% CI: 23.5%-37.6%), respectively. The primary outcome was significantly lower at 10 years in anatomically repaired patients who had surgery at <5 years of age and who had preoperative pulmonary artery banding (P
heterogeneity < 0.01)., Conclusions: Anatomic repair of ccTGA patients results in higher overall and reintervention-free survival compared to physiologic repair. Specifically, patients who had anatomic repair at <5 years of age or who had preoperative pulmonary artery banding have better survival., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. All rights reserved.)- Published
- 2024
- Full Text
- View/download PDF
24. Calcific Aortic Valve Disease: Lp(a) Takes the Heat, But Is OxPL Really Fanning the Flames?
- Author
-
Annink ME, Boekholdt SM, and Stroes ESG
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Stroes has received lecturing/Advisory Board fees from Amgen, Sanofi, Novo Nordisk, Novartis, Ionis, and AstraZeneca. The other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
25. Oxidized Phospholipids and Calcific Aortic Valvular Disease.
- Author
-
Bhatia HS, Dweck MR, Craig N, Capoulade R, Pibarot P, Trainor PJ, Whelton SP, Rikhi R, Lidani KCF, Post WS, Tsai MY, Criqui MH, Shapiro MD, Budoff MJ, DeFilippis AP, Thanassoulis G, and Tsimikas S
- Subjects
- Humans, Female, Aged, Male, Middle Aged, Disease Progression, Oxidation-Reduction, Aged, 80 and over, Apolipoprotein B-100 blood, Incidence, Prevalence, Aortic Valve Disease epidemiology, Calcinosis epidemiology, Calcinosis blood, Aortic Valve pathology, Aortic Valve Stenosis epidemiology, Aortic Valve Stenosis blood, Lipoprotein(a) blood, Phospholipids blood
- Abstract
Background: Oxidized phospholipids (OxPLs) are carried by apolipoprotein B-100-containing lipoproteins (OxPL-apoB) including lipoprotein(a) (Lp[a]). Both OxPL-apoB and Lp(a) have been associated with calcific aortic valve disease (CAVD)., Objectives: This study aimed to evaluate the associations between OxPL-apoB, Lp(a) and the prevalence, incidence, and progression of CAVD., Methods: OxPL-apoB and Lp(a) were evaluated in MESA (Multi-Ethnic Study of Atherosclerosis) and a participant-level meta-analysis of 4 randomized trials of participants with established aortic stenosis (AS). In MESA, the association of OxPL-apoB and Lp(a) with aortic valve calcium (AVC) at baseline and 9.5 years was evaluated using multivariable ordinal regression models. In the meta-analysis, the association between OxPL-apoB and Lp(a) with AS progression (annualized change in peak aortic valve jet velocity) was evaluated using multivariable linear regression models., Results: In MESA, both OxPL-apoB and Lp(a) were associated with prevalent AVC (OR per SD: 1.19 [95% CI: 1.07-1.32] and 1.13 [95% CI: 1.01-1.27], respectively) with a significant interaction between the two (P < 0.01). Both OxPL-apoB and Lp(a) were associated with incident AVC at 9.5 years when evaluated individually (interaction P < 0.01). The OxPL-apoB∗Lp(a) interaction demonstrated higher odds of prevalent and incident AVC for OxPL-apoB with increasing Lp(a) levels. In the meta-analysis, when analyzed separately, both OxPL-apoB and Lp(a) were associated with faster increase in peak aortic valve jet velocity, but when evaluated together, only OxPL-apoB remained significant (ß: 0.07; 95% CI: 0.01-0.12)., Conclusions: OxPL-apoB is a predictor of the presence, incidence, and progression of AVC and established AS, particularly in the setting of elevated Lp(a) levels, and may represent a novel therapeutic target for CAVD., Competing Interests: Funding Support and Author Disclosures Dr Bhatia is supported by National Institutes of Health (NIH) grants 1K08HL166962 and 1KL2TR001444. Dr Dweck is supported by the British Heart Foundation (FS/SCRF/21/32010) and is the recipient of the Sir Jules Thorn Award for Biomedical Research 2015 (15/JTA). Dr Craig is supported by the Medical Research Council (MR/Y009932/1). Dr Rikhi is supported by the National Heart, Lung, and Blood Institute (NHLBI) of NIH under Award Number T32HL076132. Dr Budoff was supported by R01 HL071739 and R01HL146666. Dr Thanassoulis was supported by NIH R01 HL128550-04 and is funded by the FRQS as a Senior Clinician Scientist. Dr Tsimikas is supported by NHLBI grants R01 HL159156 and HL170224. The MESA was supported by contracts 75N92020D00001, HHSN268201500003I, N01-HC-95159, 75N92020D00005, N01-HC-95160, 75N92020D00002, N01-HC-95161, 75N92020D00003, N01-HC-95162, 75N92020D00006, N01-HC-95163, 75N92020D00004, N01-HC-95164, 75N92020D00007, N01-HC-95165, N01-HC-95166, N01-HC-95167, N01-HC-95168, and N01-HC-95169 from NHLBI, and by grants UL1-TR-000040, UL1-TR-001079, and UL1-TR-001420 from the National Center for Advancing Translational Sciences (NCATS). The content is solely the responsibility of the authors and does not necessarily represent the official views of NIH. Dr Bhatia has served on the scientific advisory boards for Novartis, Abbott, and Arrowhead; and has served as a consultant for Kaneka and Novartis. Dr Dweck has received speaker fees from Pfizer, Radcliffe Cardiology, Amarin, Bristol Myers Squibb, Edwards, and Novartis; and has received consultancy fees from Novartis, Jupiter Bioventures, AstraZeneca, Beren, and Silence therapeutics. Dr Capoulade has received an honorarium from Novartis. Dr Shapiro has received grants from Amgen, Boehringer Ingelheim, 89Bio, Esperion, Genentech, Novartis, Ionis, Merck, and New Amsterdam; has served on scientific advisory boards of Amgen, Agepha, Ionis, Novartis, Precision BioScience, and New Amsterdam; and has served as a consultant for Ionis, Novartis, Regeneron, Aidoc, Shanghai Pharma Biotherapeutics, Kaneka, and Novo Nordisk. Dr Budoff has received grant support from Amgen. Dr Tsimikas is a co-inventor and receives royalties from patents owned by the University of California-San Diego (UCSD); is a co-founder and has an equity interest in Oxitope and Kleanthi Diagnostics; is a consult to Novartis; and has a dual appointment at UCSD and Ionis Pharmaceuticals (the terms of this arrangement have been reviewed and approved by UCSD in accordance with its conflict-of-interest policies). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
26. Screening for Abdominal Aortic Aneurysms Still Prevents Ruptures: A Secondary Analysis of the VIVA Trial.
- Author
-
Dahl M, Liisberg M, Stenehjem M, Al Obeidi I, and Sanddal Lindholt J
- Abstract
Competing Interests: Funding Support and Author Disclosures This work was supported by the 7th European Framework Program, Central Denmark Region, Viborg Hospital, and The Danish Council for Independent Research. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
27. Cardiac MRI Predictors of Arrhythmic Sudden Cardiac Events in Patients With Fontan Circulation.
- Author
-
Wolfe NK, Schiff MD, Olivieri LJ, Christopher AB, Fogel M, Slesnick TC, Krishnamurthy R, Muthurangu V, Dorfman AL, Lam CZ, Weigand J, Robinson JD, Rathod RH, and Alsaied T
- Subjects
- Humans, Male, Female, Adolescent, Risk Factors, Child, Young Adult, Predictive Value of Tests, Follow-Up Studies, Adult, Arrhythmias, Cardiac epidemiology, Arrhythmias, Cardiac etiology, Fontan Procedure adverse effects, Heart Defects, Congenital surgery, Heart Defects, Congenital complications, Death, Sudden, Cardiac epidemiology, Death, Sudden, Cardiac etiology, Magnetic Resonance Imaging, Cine methods, Registries
- Abstract
Background: Among patients with congenital heart disease, those with single ventricles have the highest risk of early mortality. Sudden cardiac death is an important cause of death in this population. Understanding the risk factors for sudden cardiac events (SCE) in Fontan patients could improve prediction and prevention., Objectives: The goal of this study was to determine the prevalence of SCE and risk factors for SCE in the Fontan population., Methods: The Fontan Outcomes Registry Using CMR Examinations (FORCE) is an international registry collecting clinical and imaging data on Fontan patients. SCE was defined as: 1) cardiac arrest from a shockable rhythm; 2) need for emergent cardioversion/defibrillation; or 3) documented sustained ventricular tachycardia. Univariate and multivariate Cox proportional hazards regression models estimated hazard ratios for predictors of SCE., Results: Our sample included 3,132 patients (41% female). The median age at first cardiac magnetic resonance was 14.6 years. SCE was experienced by 3.5% (n = 109) over a median follow-up time of 4.00 years. Of the 109 patients with SCE, 39 (36%) died. On multivariable analysis, NYHA functional class >II (HR: 4.91; P < 0.0001), history of protein-losing enteropathy/plastic bronchitis (HR: 2.37; P = 0.0082), single-ventricle end-diastolic volume index >104 mL/m
2 (HR: 3.15; P < 0.0001), and ejection fraction <50% (HR: 1.73; P = 0.0437) were associated with SCE. Kaplan-Meier analysis demonstrated that in patients with none of the above risk factors, the 4-year freedom from SCE was 99.5%., Conclusions: SCE occurred in 3.5% of the study population, and one-third of patients who experienced SCE died. Mild ventricular dysfunction and dilatation by cardiac magnetic resonance, NYHA functional class, and history of protein-losing enteropathy/plastic bronchitis were associated with SCE., Competing Interests: Funding Support and Author Disclosures The FORCE registry is funded through a grant from Additional Ventures and Evan’s Heart. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
- Full Text
- View/download PDF
28. Assessing Risk of Sudden Death in Patients With Fontan Circulation: Thinking Outside the (Single-Center) Box.
- Author
-
DiLorenzo MP and Farooqi KM
- Abstract
Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
29. Using Selection Criteria From the DanGer Shock Trial in a Contemporary Cohort With Cardiogenic Shock.
- Author
-
O'Brien CG, Brusca SB, Barnett CF, Berg DD, Baird-Zars VM, Park JG, Bohula EA, and Morrow DA
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Brusca has received research funding from Johnson and Johnson. Dr Barnett has received research funding from Merck and Co; and has received consulting fees from Zoll, Abiomed, and Abbott. Dr Berg has received consulting fees from AstraZeneca, Pfizer, Mobility Bio, Inc, and Youngene Therapeutics; has received honoraria from the Metabolic Endocrine Education Forum and USV Private Limited; and participates on clinical endpoint committees for studies sponsored by Beckman Coulter, Kowa Pharmaceuticals, Novo Nordisk, and Tosoh Biosciences. Drs Berg, Baird-Zars, Park, Bohula, and Morrow are members of the TIMI Study Group, which has received institutional research grant support through Brigham and Women’s Hospital from Abbott, Abiomed, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Inc, Daiichi-Sankyo, Eisai, Intarcia, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Inc, Roche, Siemens Healthcare Diagnostics, Inc, The Medicines Company, and Zora Biosciences. Dr Morrow has received consulting fees from Abbott Laboratories, ARCA Biopharma, InCarda, Inflammatix, Merck and Co, Novartis, and Roche Diagnostics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
30. Impact of Renal and Liver Function on Clinical Outcomes Following Tricuspid Valve Transcatheter Edge-to-Edge Repair.
- Author
-
Jorde UP, Benza R, McCarthy PM, Ailawadi G, Whisenant B, Makkar R, Tadros P, Naik H, Fam N, Sauer AJ, Murthy S, Kar S, von Bardeleben RS, Hahn RT, Hamid N, Zbinden J, Sorajja P, and Adams D
- Subjects
- Humans, Female, Male, Aged, Prospective Studies, Cardiac Catheterization methods, Treatment Outcome, Middle Aged, Tricuspid Valve surgery, Tricuspid Valve diagnostic imaging, Tricuspid Valve physiopathology, Follow-Up Studies, Severity of Illness Index, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency surgery
- Abstract
Background: The TRILUMINATE Pivotal trial is a prospective, randomized, controlled study of patients with severe tricuspid regurgitation (TR). Venous congestion due to TR may lead to end-organ dysfunction and failure. The potential to reverse or stop further deterioration in end-organ function is an important goal of treatment., Objectives: This study sought to examine changes in end-organ function after tricuspid transcatheter edge-to-edge repair (TEER) and assess the association of baseline end-organ function with heart failure (HF) hospitalizations and mortality., Methods: Subjects were randomized 1:1 to either the TEER group (TriClip System + medical therapy) or control group (medical therapy alone). Laboratory assessments and TR grading were performed at baseline and at all follow-up visits (discharge, 30 days, 6 months, and 12 months). An independent echocardiography core laboratory assessed TR severity and an independent clinical events committee adjudicated adverse events., Results: A total of 572 subjects were enrolled and randomized (285 TEER, 287 control patients). Patients with moderate-to-severe end-organ impairment (estimated glomerular ejection fraction [eGFR] <45 mL/min/1.73 m
2 or Model for End-Stage Liver Disease excluding INR [MELD-XI] >15) at baseline had increased incidence of HF hospitalization and death through 12 months, regardless of treatment. There were no statistically significant differences between TEER and control patients in eGFR or MELD-XI at 12 months. In subgroup analyses examining only successful TEER patients (moderate or less TR at discharge) compared with control patients, as well as when censoring patients with normal baseline values, both eGFR (+3.55 ± 1.04 mL/min/1.73 m2 vs 0.07 ± 1.10 mL/min/1.73 m2 ; P = 0.022) and MELD-XI (-0.52 ± 0.18 vs 0.34 ± 0.18; P = 0.0007) improved., Conclusions: Baseline end-organ function was associated with HF hospitalization and death in patients with severe TR. At 12 months, eGFR and MELD-XI scores were not statistically significantly different between the overall TEER and control groups. In patients who had successful TEER, statistically significant, yet small, favorable changes occurred for both eGFR and MELD-XI. Further investigation is needed to assess whether these changes in end-organ function after successful TEER are clinically meaningful and reduce HF hospitalization or death. (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal [TRILUMINATE Pivotal]; NCT03904147)., Competing Interests: Funding Support and Author Disclosures The TRILUMINATE Pivotal trial was funded and sponsored by Abbott. Dr Jorde has received consulting fees from Abbott and Edwards Lifesciences. Dr Benza has received consulting fees from Abbott and Bayer HealthCare Pharmaceuticals Inc; and has been an endpoint review committee member for United Therapeutics. Dr McCarthy has been a coprincipal investigator of REPAIR-MR (unpaid) for Abbott; has served on advisory boards for Abbott and egnite; has received royalties from Edwards Lifesciences; and has received speaker fees from Medtronic, Edwards Lifesciences, and Atricure. Dr Ailawadi has received consulting fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Whisenant has received consulting fees from Abbott and Edwards Lifesciences. Dr Makkar has received grants and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consulting fees from Cordis Corporation and Medtronic; and has performed unpaid trial activities for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Tadros has received consulting fees from Abbott and Edwards Lifesciences. Dr Naik has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Fam has received consulting fees from Abbott. Dr Sauer has received grants and institutional research support from Saint Luke’s Mid America Heart Institute, Bayer, CSL Vifor, Pfizer, Rivus, AstraZeneca, Novo Nordisk, Impulse Dynamics, 35Pharma, Abbott, Boston Scientific, General Prognostics, Acorai, Story Health, and Amgen; and has received honoraria for speaking or advising from Bayer, CSL Vifor, Abbott, Impulse Dynamics, Boston Scientific, Edwards Lifesciences, Acorai, Story Health, and General Prognostics. Dr Kar has received consulting fees from Abbott, Boston Scientific, InterShunt, Medtronic, Peija, V-Wave, W.L. Gore, and Medtronic; and has served as co-principal investigator of the EXPAND and REPAIR MR trials for Abbott. Dr von Bardeleben has performed unpaid trial activities for Abbott, Edwards Lifesciences, and University of Göttingen (IIT); and has served on advisory boards or speakers bureaus for Abbott, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and NeoChord. Dr Hahn has received speaker fees from Abbott, Baylis Medical Company Inc, Edwards Lifesciences, Medtronic, and Philips. Dr Hamid has received consulting fees from 4C Medical Technologies, Inc, Alleviant Medical, Inc, AMX, Anteris Technologies Corporation, Edwards Lifesciences, Philips, Valcare Med Ltd, VDyne, and W.L. Gore & Associates, Inc. Dr Zbinden has been a senior clinical scientist for Abbott. Dr Sorajja is co-principal investigator for the TRILUMINATE Pivotal trial; has served on advisory boards for Anteris Technologies and VDyne; and has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Shifamed, TriFlo, and W.L. Gore & Associates, Inc. Dr Adams is co-principal investigator for the TRILUMINATE Pivotal trial; and receives royalties from Edward Lifesciences and Medtronic. Dr Murthy has reported that she has no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)- Published
- 2024
- Full Text
- View/download PDF
31. Excess Mortality and Hospitalizations Associated With Seasonal Influenza in Patients With Heart Failure.
- Author
-
Modin D, Claggett B, Johansen ND, Solomon SD, Trebbien R, Grove Krause T, Stæhr Jensen JU, Porsborg Andersen M, Gislason G, and Biering-Sørensen T
- Subjects
- Humans, Denmark epidemiology, Male, Female, Aged, Middle Aged, Influenza, Human mortality, Influenza, Human complications, Influenza, Human epidemiology, Heart Failure mortality, Heart Failure epidemiology, Hospitalization statistics & numerical data, Seasons
- Abstract
Background: Influenza virus may cause severe infection in patients with heart failure. It is known that influenza infection is associated with increased morbidity and mortality in patients with heart failure. However, less is known about the excess burden of morbidity and mortality caused by influenza infection in patients with heart failure at a population level., Objectives: The purpose of this study was to estimate the excess burden of morbidity and mortality as determined by annual excess number of deaths and hospitalizations associated with influenza infection in patients with heart failure in Denmark., Methods: We collected nationwide data on weekly number of deaths and hospitalizations among patients with heart failure in Denmark and weekly estimates of influenza circulation as determined by the proportion of positive influenza samples analyzed at all Danish Hospitals. These data were correlated in a time series linear regression model, and this model was used to estimate the annual excess number of deaths and hospitalizations attributable to influenza circulation among patients with heart failure in Denmark. The model also included data on weekly mean temperature and restricted cubic spline terms to account for seasonality and trends over time., Results: Data were available from 2010 to 2018 encompassing 8 influenza seasons with an annual mean of 25,180 samples tested for influenza at Danish hospitals. Among an annual mean of 70,570 patients with heart failure, our model estimated that influenza activity was associated with an annual excess of 250 all-cause deaths (95% CI: 144-489 deaths) corresponding to 2.6% of all all-cause deaths (95% CI: 1.5%-5.1%) in patients with heart failure. Similarly, influenza activity was associated with an annual excess of 115 cardiovascular deaths (95% CI: 62-244 deaths) corresponding to 2.9% of all cardiovascular deaths (95% CI: 1.5%-6.1%). Influenza activity was also associated with an annual excess of 251 hospitalizations for pneumonia or influenza (95% CI: 107-533 hospitalizations) corresponding to 5.0% of all hospitalizations for pneumonia or influenza., Conclusions: Our results indicate that influenza activity likely causes substantial morbidity and mortality among patients with heart failure. Notably, our study suggests that approximately 2.6% of all deaths and 5.0% of all hospitalizations with influenza or pneumonia may be attributed to influenza in patients with heart failure., Competing Interests: Funding Support and Author Disclosures Dr Claggett has served as a consultant for Alnylam, Corvia, Cytokinetics, CVRX, Cardurion, Intellia, Rocket, and Cardior. Dr Solomon has received research grants from Alexion, Alnylam, Applied Therapeutics, AstraZeneca, Bellerophon, Bayer, Bristol Myers Squibb, Boston Scientific, Cytokinetics, Edgewise, Eidos/Bridgebio, Gossamer, GlaxoSmithKline, Ionis, Lilly, National Institutes of Health/National Heart, Lung, and Blood Institute, Novartis, Novo Nordisk, Respicardia, Sanofi Pasteur, Tenaya, Theracos, and US2.AI; and has consulted for Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Bristol Myers Squibb, Cardior, Cardurion, Corvia, Cytokinetics, GlaxoSmithKline, Lilly, Novartis, Roche, Theracos, Quantum Genomics, Tenaya, Sanofi-Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, and Valo. Dr Biering-Sørensen has received research grants from Sanofi Pasteur, GlaxoSmithKline, Novo Nordisk, AstraZeneca, Boston Scientific, Pfizer, and GE Healthcare; has received consulting fees from Novo Nordisk, IQVIA, Parexel, Amgen, CSL Seqirus, GlaxoSmithKline, and Sanofi Pasteur; and has received lecture fees from Bayer, Novartis, Sanofi Pasteur, GE Healthcare, and GlaxoSmithKline. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
32. Major Bleeding and Mortality After Revascularization of Left Main Disease.
- Author
-
Giustino G, Sabik JF 3rd, Serruys PW, Puskas JD, Karmpaliotis D, Kandzari DE, Morice MC, Ragosta M 3rd, Zhang Z, Dressler O, Redfors B, Ben-Yehuda O, Sharma SK, Kappetein AP, and Stone GW
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Postoperative Hemorrhage epidemiology, Postoperative Hemorrhage mortality, Postoperative Hemorrhage etiology, Follow-Up Studies, Incidence, Percutaneous Coronary Intervention adverse effects, Coronary Artery Bypass adverse effects, Coronary Artery Disease surgery, Coronary Artery Disease mortality
- Abstract
Background: The incidence and prognostic impact of major bleeding (MB) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) are unknown., Objectives: The goal of this study was to investigate the rates and outcomes of MB after LMCAD revascularization., Methods: In the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with unprotected LMCAD were randomized to undergo PCI (n = 948) or CABG (n = 957) and followed up for 5 years. MB was defined as TIMI major or minor bleeding, BARC (Bleeding Academic Research Consortium) types 3 to 5 bleeding, or any overt bleeding requiring blood transfusion. The association between MB and subsequent mortality was assessed in time-adjusted Cox regression models., Results: At 5 years, 217 patients (11.4%) had at least 1 MB event. Rates of 5-year MB were 7.9% after PCI vs 14.8% after CABG (OR: 0.48; 95% CI: 0.36-0.65; P < 0.0001). However, in-hospital MB was lower after PCI (3.8% vs 13.5%; OR: 0.25; 95% CI: 0.17-0.37), whereas postdischarge MB was lower after CABG (4.5% vs 2.0%; OR: 2.33; 95% CI: 1.33-3.09; P
interaction < 0.0001). All 41 postdischarge MB events after PCI occurred in patients receiving dual antiplatelet therapy. MB events within 5 years were associated with a higher subsequent risk of all-cause mortality (adjusted HR: 2.71; 95% CI: 1.95-3.77; P < 0.0001), whether in-hospital or postdischarge (Pinteraction = 1.00) and after both PCI and CABG (Pinteraction = 0.95), driven both by increased cardiovascular and non-cardiovascular mortality., Conclusions: In the EXCEL trial, CABG resulted in higher 5-year rates of all MB and in-hospital MB, although postdischarge MB was more frequent after PCI. MB after both procedures was associated with increased cardiovascular and noncardiovascular mortality within 5 years. (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)., Competing Interests: Funding Support and Author Disclosures The EXCEL trial was funded by Abbott Vascular. Dr Giustino is a consultant and proctor for Edwards Lifesciences. Dr Sabik has served as a consultant for Medtronic, Edwards, and Sorin; and has served on the advisory board for Medtronic Cardiac Surgery. Dr Serruys has served as a consultant for Abbott, Biosensors, Medtronic, Micell Technologies, SINOMED, Philips/Volcano, Xeltis, and HeartFlow. Dr Kandzari has received consulting honoraria and research/grant support from Medtronic, Biotronik, and Boston Scientific. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi-Sankyo, Ablative Solutions, CorFlow, CardioMech, Robocath, Miracor, Vectorious, Apollo Therapeutics, Elucid Bio, VALFIX, TherOx, HeartFlow, Neovasc, Ancora, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, HighLife, and Elixir; and has equity/options from Ancora, Cagent, Applied Therapeutics, BioStar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, VALFIX, and Xenter. Dr Stone’s employer, Mount Sinai Hospital, receives research grants from Abbott, Abiomed, BioVentrix, Cardiovascular Systems Inc, Philips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-Wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
- Full Text
- View/download PDF
33. Optimizing AHA/ACC Guidelines for the Digital Age: Guidelines in Evolution.
- Author
-
Otto CM, Jessup M, Kovacs RJ, and Beckman JA
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Beckman has served as a consultant for JanOne, Janssen, Novartis, Merck, Mingsight, and Antidote. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
34. High Lipoprotein(a) as a Cause of Kidney Disease: A Population-Based Mendelian Randomization Study.
- Author
-
Bay Simony S, Rørbæk Kamstrup P, Bødtker Mortensen M, Afzal S, Grønne Nordestgaard B, and Langsted A
- Abstract
Competing Interests: Funding Support and Author Disclosures This work was supported by The Danish Heart Foundation (19-R134-A9219), Beckett Foundation (19-2-4567), Direktør Jacob Madsen og Hustru Olga Madsens fond, and Herlev and Gentofte Hospital, Copenhagen University Hospital. None had any influence on the research conducted. Dr Kamstrup has received lecture honoraria or consultancies from Physicians’ Academy for Cardiovascular Education, Medscape, Silence Therapeutics, Amgen, Lilly, and Novartis. Dr Mortensen has received lecture honoraria from Novo Nordisk, AstraZeneca, Amarin, and Sanofi. Dr Nordestgaard has served as a consultant for or had talks sponsored by AstraZeneca, Sanofi, Regeneron, Ionis, Amgen, Kowa, Amarin, Novartis, Novo Nordisk, Esperion, Abbott, Silence Therapeutics, Ultragenyx, USV, Mankind, Lilly, Arrowhead, and Marea. Dr Langsted has received lecture honoraria or consultancies from Amarin and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
35. Plea for an In-Depth Analysis of the RESHAPE-HF2 Results.
- Author
-
Obadia JF, Armoiry X, Messika-Zeitoun D, Trochu JN, and Iung B
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Obadia has served on the Scientific Advisory Board or received grants from Abbott, Carmat, Edwards, Jenscare, andTricare; and has served as a consultant for Delacroix-Chevalier and Landanger. Dr Armoiry has provided scientific advice to W.L. Gore with honoraria delivered to an academic association. Dr Messika-Zeitoun has received research grant from Edwards Lifesciences; and is a consultant for PrediSurge. Dr Trochu has served as a Scientific Advisory Board member and/or received honoraria/grants from Abbott, AstraZeneca, Bristol Myers Squibb, Vifor-Pharma, Bayer, Novartis, and Boehringer Ingelheim. Dr Iung has reported that he has no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
36. Treating Hypertension With a Single (Combination) Pill: Changing the Paradigm.
- Author
-
Onuma OK
- Abstract
Competing Interests: Funding Support and Author Disclosures The author has reported that she has no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
37. M-TEER for Functional MR: Erasing All Doubt.
- Author
-
Stone GW and Penta B
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Stone has received speaker honoraria from Pulnovo, Medtronic, Amgen, Boehringer Ingelheim, and Abiomed; has served as a consultant to CorFlow, Cardiomech, Robocath, Daiichi-Sankyo, Ablative Solutions, Vectorious, Miracor, Apollo Therapeutics, Elucid Bio, Abbott, Cardiac Success, Occlutech, Millennia Biopharma, Remote Cardiac Enablement, Valfix, Zoll, HeartFlow, Shockwave, Impulse Dynamics, Adona Medical, Oxitope, HighLife, Elixir, and Aria; has equity/options from Cardiac Success, Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Valfix, and Xenter; and his employer, Mount Sinai Hospital, has received research grants from Shockwave, Biosense Webster, Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Vascular Dynamics, Pulnovo, V-wave, and PCORI (via Weill Cornell Medical Center). Dr Penta has reported that he has no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
38. Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2.
- Author
-
Ponikowski P, Friede T, von Bardeleben RS, Butler J, Shahzeb Khan M, Diek M, Heinrich J, Geyer M, Placzek M, Ferrari R, Abraham WT, Alfieri O, Auricchio A, Bayes-Genis A, Cleland JGF, Filippatos G, Gustafsson F, Haverkamp W, Kelm M, Kuck KH, Landmesser U, Maggioni AP, Metra M, Ninios V, Petrie MC, Rassaf T, Ruschitzka F, Schäfer U, Schulze PC, Spargias K, Vahanian A, Zamorano JL, Zeiher A, Karakas M, Koehler F, Lainscak M, Öner A, Mezilis N, Theofilogiannakos EK, Ninios I, Chrissoheris M, Kourkoveli P, Papadopoulos K, Smolka G, Wojakowski W, Reczuch K, Pinto FJ, Wiewiórka Ł, Streb W, Adamo M, Santiago-Vacas E, Friedrich Ruf T, Gross M, Tongers J, Hasenfuß G, Schillinger W, and Anker SD
- Subjects
- Humans, Male, Female, Aged, Severity of Illness Index, Aged, 80 and over, Cardiac Catheterization methods, Treatment Outcome, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation trends, Mitral Valve Insufficiency surgery, Heart Failure therapy, Heart Failure mortality, Heart Failure surgery, Hospitalization statistics & numerical data, Hospitalization trends
- Abstract
Background: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results., Objectives: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER., Methods: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm
2 ; 14% >0.40 cm2 , 23% <0.20 cm2 ) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization., Results: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06)., Conclusions: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF., Competing Interests: Funding Support and Author Disclosures Prof Ponikowski has received a grant from Vifor Pharma; has received consulting fees and/or honoraria from Boehringer Ingelheim, AstraZeneca, Vifor Pharma, Servier, Novartis, Berlin Chemie, Bayer, Abbott Vascular, Novo Nordisk, Pharmacosmos, Moderna, Pfizer, and Abbott Vascular; and has received fees for trial committee work from Boehringer Ingelheim, Vifor Pharma, Novo Nordisk, Pharmacosmos, and Moderna. Dr Friede has received payments to his institution from Abbott; has received grants from Deutsche Forschungsgemeinschaft (DFG), Federal Joint Committee (G-BA), and European Commission; has received consulting fees from Actimed, Bayer, BMS, CSL Behring, Daiichi-Sankyo, Galapagos, Immunic, KyowaKirin, LivaNova, Minoryx, Novartis, RECARDIO, Relaxera, Roche, Servier, Viatris, and Vifor; has received payments from Fresenius Kabi and PINK gegen Brustkrebs; is a trial data monitoring committee member for Aslan, Bayer, Biosense Webster, Enanta, Galapagos, IQVIA, Novartis, PPD, Recordati, Roche, and VICO Therapeutics; and is a trial steering committee member for CSL Behring. Dr von Bardeleben has received an EchoCoreLab IIT grant from Clinical Trial Unit of UMG Göttingen; has received consulting fees from Abbott Vascular, Jenscare, Edwards Lifesciences, and Medtronic; has received honoraria from Abbott Vascular, Jenavalve, Jenscare, Edwards Lifesciences, Medtronic, Philips, Siemens; and is a trial committee member for Medtronic and Heart Valve Society (unpaid), and EU SHD Coalition (unpaid). Dr Butler has received consulting fees from Abbott, American Regent, Amgen, Applied Therapeutic, AskBio, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardiac Dimension, Cardiocell, Cardior, Cardiorem, CSL Bearing, CVRx, Cytokinetics, Daxor, Edwards Lifesciences, Element Science, Faraday, Foundry, G3P, Innolife, Impulse Dynamics, Imbria, Inventiva, Ionis, Lexicon, Lilly, LivaNova, Janssen, Medtronic, Merck, Occlutech, Owkin, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharmain, Pfizer, Prolaio, Regeneron, Renibus, Roche, Salamandra, Sanofi, SC Pharma, Secretome, Sequana, SQ Innovation, Tenex, Tricog, Ultromics, Vifor, and Zoll; and has received honoraria from Novartis, Boehringer Ingelheim-Lilly, AstraZeneca, Impulse Dynamics, and Vifor. Dr Khan has participated in a data safety monitoring board or advisory board for Bayer. Dr Ferrari has received honoraria and support for attending meetings from Servier, Merck Serono, Bayer, Lupin, and Sunpharma. Dr Abraham has received payments from Abbott; has received grants from National Institutes of Health 1 UG3 / UH3 HL140144-01; has received consulting fees from Zoll Respicardia; has received honoraria from Impulse Dynamics, Edwards Lifesciences, and Abbott; and is an advisory board member for Sensible Medical, WhiteSwell, AquaPass, Cordio Medical, and Boehringer Ingelheim. Dr Auricchio has received consulting fees and honoraria from Boston Scientific, Medtronic, Microport CRM, Philips, Xspline, and Abbott. Dr Bayes-Genis has lectured and/or participated in advisory boards for Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Novo Nordisk, Roche Diagnostics, and Vifor. Dr Cleland has received grants from Bristol Myers Squibb, CSL-Vifor, British Heart Foundation, and Pharmacosmos; has received consulting fees from Pharmacosmos, CSL-Vifor, and Biopeutics; and has received honoraria from Pharmacosmos. Dr Filippatos has received honoraria from Bayer, Boehringer Ingelheim, Servier, and Novartis; has served on the trial committee boards for Bayer, Medtronic, Boehringer Ingelheim, Vifor, Amgen, Servier, Impulse Dynamics, Cardior, and Novo Nordisk; and has served on the boards of the Heart Failure Association and JACC Heart Failure. Dr Gustafsson has received consulting fees and/or honoraria from Abbott, Bayer, Pfizer, and AstraZeneca; has participated on the trial committee board of AdJuCor; and has served on the board of the Heart Failure Association. Dr Haverkamp has received consulting fees and/or honoraria from Bayer and AstraZeneca. Dr Kelm has received grants or contracts from Microvision Medical Holding B.V., Edwards Lifesciences, Mars Scientific Advisory Council, Abiomed Europe GmbH, B. Braun Melsungen AG, DFG SFB 1116, EU Horizon 2020, and Daiichi-Sankyo Deutschland GmbH; and has received payment or honoraria from Bayer Vital GmbH, Abiomed Europe GmbH, AstraZeneca, Amarin GmbH, and CTI congress GmbH. Dr Landmesser has received grants from Abbott and Novartis; and has received consulting fees and honoraria from Abbott. Dr Maggioni has participated on trial committee boards for Bayer, AstraZeneca, Novartis, and Sanofi. Dr Metra has received consulting fees from Abbott Structural Heart, Boehringer Ingelheim, AstraZeneca, Roche Diagnostics, Edwards Lifesciences, Novo Nordisk, and Bayer. Dr Petrie has received grants from Boehringer Ingelheim, Roche Diagnostics, SQ Innovations, AstraZeneca, Novartis, Novo Nordisk, Medtronic, Boston Scientific, and Pharmacosmos; has received consulting fees and/or honoraria from Akero, Applied Therapeutics, Amgen, AnaCardio, Biosensors, Boehringer Ingelheim, Corteria, FIRE-1, Biosensors, REPRIEVE, Corvia, Novartis, AstraZeneca, Novo Nordisk, AbbVie, Bayer, Horizon Therapeutics, Takeda, Cardiorentis, Pharmacosmos, Roche Pharma, Siemens, Eli Lilly, Vifor, New Amsterdam, Moderna, Teikoku, LIB Therapeutics, and 3R Lifesciences; and has participated on a data safety monitoring board or advisory board for AstraZeneca, Moderna, and Teikoku. Dr Rassaf has received consulting fees and/or honoraria from BMS, AstraZeneca, Pfizer, Novartis, Bayer, Daiichi-Sankyo, and CVRxInc; and has pending patent applications regarding amelioration and treatment of infarct damage (W02023079141A2), blood pressure lowering composition (EP3646861A1), and Bnip3 peptides for the treatment of reperfusion injury (C=2021015130A2). Dr Ruschitzka has not received personal payments by pharmaceutical companies or device manufacturers in the last 3 years; the Department of Cardiology (University Hospital of Zurich/University of Zurich); has received research, educational, and/or travel grants from Abbott, Abiomed, Alexion, Amgen, AstraZeneca, At the Limits Ltd Bayer, Berlin Heart, B. Braun, Biosense Webster, Biosensors Europe AG, Biotronik, BMS, Boehringer Ingelheim, Boston Scientific, Bracco, Cardinal Health Switzerland, Concept Medical, Corteria, CSL, Daiichi-Sankyo, Diatools AG, Edwards Lifesciences, Guidant Europe NV (BS), Hamilton Health Sciences, IHF, Innosuisse, Johnson/Johnson, Kaneka Corporation, Kantar, Kiniksa, Labormedizinisches Zentrum, MedAlliance, Medical Education Global Solutions, Medtronic, MicroPort, MSD, Mundipharma Medical Company, Novartis, Novo Nordisk, Orion, Pfizer, Quintiles Switzerland Sarl, Recor Medical, Roche Diagnostics, Roche Pharma, Sahajanand IN, Sanofi, Sarstedt AG, Servier, SIS Medical, Sorin CRM SAS, SSS International Clinical Research, Stromal, Terumo Deutschland, Trama Solutions, V-Wave, Vascular Medical, Vifor, Wissens Plus, and ZOLL. Dr Schäfer has received grants, consulting fees, honoraria, and personal fees for consultancies, trial committee work, and/or lectures from Abbott Vascular, Edwards Lifesciences, and Polares Medical. Dr Schulze has received grants from Boehringer Ingelheim, Abiomed Inc, Edwards Lifesciences Inc, Cytosorb Inc, and Boston Scientific; and has received consulting fees and/or honoraria from Bayer, AstraZeneca, Daiichi-Sankyo, Novartis, Actelion, Roche, Sanofi, Pharmacosmos, Medtronic, Thoratec, Boehringer Ingelheim, HeartWare, Coronus, Abbott, Boston Scientific, St. Jude Medical, Abiomed, and DGK, and trial committee work for Abbott, Abiomed. Dr Spargias has received fees for proctoring for Abbott Vascular. Dr Vahanian has participated on a data safety monitoring board for Edwards Lifesciences, VenusTech, and Mayo Clinic. Dr Zamorano has received personal payments or honoraria from Viatris, Bayer, and Novartis. Dr Zeiher has received grants or contracts from or served on scientific advisory boards for AstraZeneca, Boehringer Ingelheim, and Novo Nordisk. Dr Koehler has received grants for Project 5G-MedCamp from the German Federal Ministry of Economics and climate protection (BMWK) and grants for projects RESKRIVER and 6 G Health; and has received consulting fees and/or payments or honoraria from BIOTRONIK, Boehringer Ingelheim, Sanofi Germany GmbH, Novartis Germany (till 2022), and AMGEN Germany (in 2021). Dr Lainscak has received a grant from Slovenian Research Agency; and has received honoraria from Novartis, Boehringer Ingelheim, and AstraZeneca. Drs Mezilis and Theofilogiannakos have received support from Abbott for attending meetings. Dr Chrissoheris has received fees for proctoring from Abbott Vascular and Edwards Lifesciences; and has received honoraria from Edwards Lifesciences. Dr Papadopoulos has received consulting fees and honoraria from GE Healthcare. Dr Smolka has received fees for proctoring for Abbott Vascular. Dr Wojakowski has received consulting fees and/or honoraria from Abbott Vascular, Medtronic, and Edwards Lifesciences. Dr Reczuch has received honoraria for lectures from Abbott. Dr Pinto has received consulting fees and/or honoraria from Boehringer Ingelheim, Daichi-Sankyo, Novartis, Servier, Vifor, and Zydus; and participated on advisory boards for Medtronic, Novartis, Servier, and Vifor. Dr Adamo has received honoraria from Abbott Vascular and Edwards Lifesciences. Dr Ruf has received fees for proctoring and consulting from Abbott Laboratories and Edwards Lifesciences. Dr Hasenfuß has received personal fees from AstraZeneca, Boehringer, Corvia, Impulse Dynamics, Novartis, Pfizer, and Servier; and has served on trial committees for AstraZeneca, Boehringer, Corvia (no honoraria), Impulse Dynamics, Novartis, Servier, and Vifor Pharma. Dr Schillinger has received consulting and lecture fees and travel expenses from Abbott Vascular. Dr Anker has received grants and personal fees from Vifor and Abbott Vascular; has received personal fees for consultancies, trial committee work, and/or lectures from Actimed, AstraZeneca, Bayer, Bioventrix, Boehringer Ingelheim, Brahms, Cardiac Dimensions, Cardior, Cordio, CVRx, Cytokinetics, Edwards Lifesciences, Farraday Pharmaceuticals, GSK, HeartKinetics, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Occlutech, Pfizer, Regeneron, Relaxera, Repairon, Scirent, Sensible Medical, Servier, Vectorious, and V-Wave; and is named as coinventor of two patent applications regarding MR-proANP (DE 102007010834 & DE 102007022367), but he does not benefit personally from the related issued patents. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
- Full Text
- View/download PDF
39. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension.
- Author
-
Rodgers A, Salam A, Schutte AE, Cushman WC, de Silva HA, Di Tanna GL, Grobbee D, Narkiewicz K, Ojji DB, Poulter NR, Schlaich MP, Oparil S, Spiering W, Williams B, Wright JT Jr, Gutierez A, Sanni A, Lakshman P, McMullen D, Ranasinghe G, Gianacas C, Shanthakumar M, Liu X, Wang N, and Whelton P
- Subjects
- Humans, Male, Female, Middle Aged, Double-Blind Method, Treatment Outcome, Aged, Blood Pressure drug effects, Dose-Response Relationship, Drug, Adult, Hypertension drug therapy, Amlodipine administration & dosage, Amlodipine adverse effects, Indapamide administration & dosage, Indapamide adverse effects, Antihypertensive Agents administration & dosage, Antihypertensive Agents adverse effects, Telmisartan administration & dosage, Drug Combinations
- Abstract
Background: Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension., Objectives: The authors conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety., Methods: This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event., Results: From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 ¼ dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37%, 65%, and 70% for placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P < 0.001 vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group., Conclusions: In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306)., Competing Interests: Funding Support and Author Disclosures This trial was funded by George Medicines Pty Ltd (GM). The trial was designed by The Steering Committee, who were responsible for the study protocol. The funder of the study consulted with the U.S. Food and Drug Administration to ensure the trial design was suitable to inform an application for regulatory approval; the funder GM provided comments on a draft of the publication. The Steering Committee had full access to all the data, wrote and had final responsibility for the publication. Prof Rodgers, Dr Salam, Prof Schutte, C. ianacas, M. Shanthakumar, Dr Liu, and Dr Wang are employed at The George Institute for Global Health (TGI), which holds an interest in GM via its social enterprise arm, George Institute Ventures. None of the TGI staff have any personal financial interest in GM. Prof Rodgers is seconded part-time to GM. TGI holds patents for ultra -low-dose fixed-dose combination products for the treatment of hypertension and diabetes, and Prof Rodgers is listed as one of the inventors (granted: U.S. 10,369,156; U.S. 10,799,487; U.S. 10,322,117; U.S. 11,033,544; U.S. 11,478,462; pending: U.S. 17/932,982; U.S. 18/446,268; U.S. 17/ 598,122; U.S. 17/317,614; U.S. 17/527,084; U.S. 17/527,085; U.S. 17/ 527,087). Prof Rodgers does not have a financial interest in these patents. None of the other authors have a financial interest in GM or have received funding for their independent contribution to the GMRx2 program. Dr Schutte has received consulting fees and/or speaker honoraria from Omron Healthcare, Aktiia, Medtronic, Servier, Abbott, Sanofi, Sun Pharmaceuticals, Novartis, and Skylabs; is co-chair of the National Hypertension Taskforce of Australia; is a board member of Hypertension Australia, and Australian Cardiovascular Alliance; and is supported by an investigator grant from the National Health and Medical Research Council of Australia (GNT 2017504). Dr Ojji has received speaker honoraria from Novartis, AstraZeneca, Servier, Swipha, and Boehringer Ingelheim for speaking at educational meetings. Dr Narkiewicz has received speaker and consulting honoraria from Bausch Health, Berlin-Chemie/Menarini, Egis, Gedeon Richter, Gilead, Idorsia, Janssen, Krka, Novo Nordisk, Polpharma, Recordati, Sandoz, Servier, and Zentiva. Dr Schlaich has received consulting fees, and/or travel fees and research support from Medtronic, Abbott, ReCor, Novartis, Servier, Pfizer, and Boehringer Ingelheim; and is the current president of Hypertension Australia and Treasurer of the World Hypertension League. Dr Cushman has received institutional grants from Recor Medical and George Medicines; and has received consulting fees from Alnylam Pharmaceuticals. Dr Poulter has received financial support from several pharmaceutical companies that manufacture BP-lowering agents; has received consultancy fees from Servier and Aktiia; has received consultancy fees for research projects and staff from Servier and Pfizer; has received consultancy fees for arranging and speaking at educational meetings from AstraZeneca, Lri Therapharma, Napi, Servier, Sanofi, Eva Pharma, Pfizer, Emcure India, Dr Reddy's Laboratories, and Zydus; and has received support from the National Institute for Health Research Senior Investigator Awards, Biomedical Research Centre funding, and the British Heart Foundation Research Centre Excellence Award. Dr Wright has received support from NIH, Ohio Department of Medicaid, Agency for Health Care Research and Quality, Medtronic, Inc, and the Northeast Ohio Neighborhood Health Center Community Board of Directors. Dr Grobbee receives funding to his department as part of the EU Horizon Hypermarker project. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
40. Percutaneous Transcatheter Edge-to-Edge Repair for Functional Mitral Regurgitation in Heart Failure: A Meta-Analysis of 3 Randomized Controlled Trials.
- Author
-
Anker MS, Porthun J, Schulze PC, Rassaf T, and Landmesser U
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Rassaf has received honoraria, lecture fees, and grant support from Edwards Lifesciences, AstraZeneca, Bayer, Novartis, Berlin Chemie, Daiichi-Sankyo, Boehringer Ingelheim, Novo Nordisk, Cardiac Dimensions, and Pfizer, all unrelated to this work. Dr Schulze has received honoraria and travel support from Bayer, AstraZeneca, Daiichi-Sankyo, Novartis, Actelion, Roche, Sanofi, Pharmacosmos, Medtronic, Thoratec, Boehringer Ingelheim, HeartWare, Coronus, Abbott, Edwards Inc, Boston Scientific, St Jude Medical, Abiomed, and the German Cardiac Society; has received research support from the National Institutes of Health, the German Research Foundation, the Else Kröner Fresenius Foundation, the German Heart Foundation, the European Society of Cardiology, Actelion, Medtronic, Federal Ministry of Education and research (BMBF), Abiomed, Boehringer Ingelheim, and Boston Scientific; and has served on advisory boards for the German Research Council, Cytokinetics, Eurotransplant, Novartis, Bayer, Pharmacosmos, AstraZeneca, Boehringer Ingelheim Inc, the German Cardiac Society, and the European Society of Cardiology. Dr Landmesser has received institutional research grants from Abbott, Amgen, Bayer, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
41. Real-World Efficacy and Safety of Inclisiran: A Single-Country, Multicenter, Observational Study (CHOLINET Registry).
- Author
-
Gargiulo P, Marzano F, Crisci M, Marcucci R, Bruzzese D, Maloberti A, Sarullo FM, Galasso G, Indolfi C, Musumeci G, Corleto A, Calabrò P, Carugo S, Casu G, Picciolo A, Ciccone MM, Bilato C, Polimeni A, Giallauria F, Catalano A, De Luca L, Niccoli G, Venturini E, Pepe M, Montisci R, Brunetti ND, Patti G, Porto I, Margonato A, Floresta M, Muscoli S, Cameli M, Andò G, Di Lorenzo E, Berteotti M, Giannattasio C, Sarullo S, Formisano C, Di Costanzo A, Delnevo F, Varbella F, Cesaro A, Franzese M, Mancusi C, Fontanarosa S, Di Santo M, Cotticelli C, Perrone Filardi F, Paolillo S, Esposito G, Corsini A, and Perrone Filardi P
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Corsini has received consulting fees and lecture fees from Algorithm, Amarin, Amgen, DOC, Fidia, Novartis, Merck Sharp & Dohme, Recordati Spa, Sanofi, Servier, and Viatris; and has received grant support from Daiichi-Sankyo. The other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
42. Intraindividual Variability in Serial Lipoprotein(a) Concentrations Among Placebo-Treated Patients in the OCEAN(a)-DOSE Trial.
- Author
-
Gaba P, Rosenson RS, López JAG, Watts GF, Leucker TM, Kuder JF, Im K, Kassahun H, Wang H, Wu Y, Wang J, Ohman EM, Sabatine MS, and O'Donoghue ML
- Abstract
Competing Interests: Funding Support and Author Disclosures The OCEAN(a)-DOSE study was supported by Amgen. Dr Rosenson has received research funding to his institution from Amgen, Arrowhead, Lilly, Novartis, and Regeneron; has received consulting fees from Amgen, Arrowhead, Avilar Therapeutics, CRISPR Therapeutics, Editas, Lilly, Lipigon, Novartis, New Amsterdam, Precision Biosciences, Regeneron, and Verve Therapeutics; has received royalties from Wolters Kluwer; has stock holdings in MediMergent, LLC; and has pending patents on analytical methods and systems for biocellular marker and detection using microfluidic profiling (PCT/US2019/026364) and compositions and methods relating to the identification and treatment of immunothrombotic conditions. Dr López is an employees and shareholder of Amgen Inc. Dr Watts has received research grants, travel support for symposia, fees for lectures or honoraria for advisory boards from Amgen, Novartis, Sanofi, Silence Therapeutics, Esperion, Novo Nordisk, Pfizer, Arrowhead, CSL Sequirus, and AstraZeneca. Dr Leucker has received research grant support from Amgen and Merck. Ms Kuder and Dr Im are members of the TIMI Study Group, which has received institutional research grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Inc, Daiichi-Sankyo, Eisai, Intarcia, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Inc, Roche, Siemens Healthcare Diagnostics, Inc, The Medicines Company, and Zora Biosciences. Drs Kassahun, Wang, Wu, and Ohman are employees and shareholders of Amgen Inc. Dr Sabatine has received research grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Daiichi-Sankyo, Eisai, Intarcia, Ionis, The Medicines Company, MedImmune, Merck, Novartis, and Pfizer; has been a consultant for Althera, Amgen, Anthos Therapeutics, AstraZeneca, Beren Therapeutics, Bristol Myers Squibb, Fibrogen, Intarcia, Merck, Moderna, Novo Nordisk, and Silence Therapeutics; and is a member of the TIMI Study Group, which has also received institutional research grant support through Brigham and Women’s Hospital from ARCA Biopharma, Inc, Janssen Research and Development, LLC, Siemens Healthcare Diagnostics, Inc, Softcell Medical Limited, Regeneron, Roche, and Zora Biosciences. Dr O’Donoghue has received grant funding via Brigham and Women’s Hospital from Amgen, Novartis, AstraZeneca, Janssen, Intarcia, and GlaxoSmithKline; and has received consulting fees from Amgen, Novartis, AstraZeneca, and Janssen. Dr Gaba has reported that she has no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
43. Finerenone, Obesity, and Heart Failure With Mildly Reduced/Preserved Ejection Fraction: Prespecified Analysis of FINEARTS-HF.
- Author
-
Butt JH, Henderson AD, Jhund PS, Claggett BL, Desai AS, Lay-Flurrie J, Viswanathan P, Lage A, Scheerer MF, Lam CSP, Senni M, Shah SJ, Voors AA, Bauersachs J, Fonseca C, Kosiborod MN, Linssen GCM, Petrie MC, Schou M, Verma S, Zannad F, Pitt B, Vaduganathan M, Solomon SD, and McMurray JJV
- Abstract
Background: Obesity is associated with excessive adipocyte-derived aldosterone secretion, independent of the classical renin-angiotensin-aldosterone cascade, and mineralocorticoid receptor antagonists may be more effective in patients with heart failure (HF) and obesity., Objectives: This study sought to examine the effects of the nonsteroidal mineralocorticoid receptor antagonist finerenone compared with placebo, according to body mass index (BMI) in FINEARTS-HF (FINerenone trial to investigate Efficacy and sAfety superioR to placebo in paTientS with Heart Failure)., Methods: A total of 6,001 patients with HF with NYHA functional class II, III, and IV, a left ventricular ejection fraction of ≥40%, evidence of structural heart disease, and elevated natriuretic peptide levels were randomized to finerenone or placebo. BMI (kg/m
2 ) was examined using World Health Organization categories, namely, underweight/normal weight (<25.0 kg/m2 ; n = 1,306); overweight (25.0-29.9 kg/m2 ; n = 1,990); obesity class I (30.0-34.9 kg/m2 ; n = 1,546); obesity class II (35.0-39.9 kg/m2 ; n = 751); and obesity class III (≥40 kg/m2 ; n = 395). The primary outcome was cardiovascular death and total worsening HF events., Results: Data on baseline BMI were available for 5,988 patients (median: 29.2 kg/m2 ; Q1-Q3: 25.5-33.6 kg/m2 ). Compared with patients who were underweight/normal weight, those with obesity class II or III had a higher risk of the primary outcome (underweight/normal weight, reference; overweight, unadjusted rate ratio: 0.96 [95% CI: 0.81-1.15]; obesity class I: 1.04 [95% CI: 0.86-1.26]; obesity class II-III: 1.26 [95% CI: 1.03-1.54]). The effect of finerenone on the primary outcome did not vary by baseline BMI (underweight/normal weight, rate ratio: 0.80 [95% CI: 0.62-1.04]; overweight: 0.91 [95% CI: 0.72-1.15]; obesity class I: 0.92 [95% CI: 0.72-1.19]; obesity class II-III: 0.67 [95% CI: 0.50-0.89]; Pinteraction = 0.32). However, when BMI was examined as a continuous variable, the beneficial effect of finerenone seemed to be greater in those with a higher BMI (Pinteraction = 0.005). A similar pattern was observed for total worsening HF events. Consistent effects across baseline BMI were observed for cardiovascular and all-cause death and improvement in the Kansas City Cardiomyopathy Questionnaire scores., Conclusions: In patients with HF with mildly reduced/preserved ejection fraction, the beneficial effects of finerenone on clinical events and symptoms were consistent, irrespective of BMI at baseline, possibly with a greater effect on the primary outcome in patients with higher BMI. (FINEARTS-HF [FINerenone trial to investigate Efficacy and sAfety superioR to placebo in paTientS with Heart Failure]; NCT04435626)., Competing Interests: Funding Support and Author Disclosures FINEARTS-HF was funded by Bayer AG. The Steering Committees of the trial designed and oversaw their conduct in collaboration with the Sponsor. The primary analyses, interpretation of the data, and initial manuscript drafting were conducted independently by the academic team. Dr Butt has received advisory board honoraria from AstraZeneca and Bayer; has received consultant honoraria from Novartis and AstraZeneca; and has received travel grants from AstraZeneca. Dr Jhund has received speakers’ fees from AstraZeneca, Novartis, Alkem Metabolics, ProAdWise Communications, Sun Pharmaceuticals; has received advisory board fees from AstraZeneca, Boehringer Ingelheim, and Novartis; has received research funding from AstraZeneca, Boehringer Ingelheim, Analog Devices Inc, Roche Diagnostics; his employer the University of Glasgow has been remunerated for clinical trial work from AstraZeneca, Bayer AG, Novartis, and Novo Nordisk; and he is a director at GCTP Ltd. Dr Claggett has received personal consulting fees from Alnylam, Bristol Myers Squibb, Cardior, Cardurion, Corvia, CVRx, Eli Lilly, Intellia, and Rocket; and has served on a data safety monitoring board for Novo Nordisk. Dr Desai has received institutional research grants (to Brigham and Women’s Hospital) from Abbott, Alnylam, AstraZeneca, Bayer, Novartis, and Pfizer; and has received personal consulting fees from Abbott, Alnylam, AstraZeneca, Bayer, Biofourmis, Boston Scientific, Medpace, Medtronic, Merck, Novartis, Parexel, Porter Health, Regeneron, River2Renal, Roche, Veristat, Verily, and Zydus. Drs Viswanathan, Lage, Scheerer, and Lay-Flurrie are full-time employees of Bayer. Dr Lam has received research support from Novo Nordisk and Roche Diagnostics; has received consulting fees from Alleviant Medical, Allysta Pharma, AnaCardio AB, Applied Therapeutics, AstraZeneca, Bayer, Biopeutics, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CardioRenal, CPC Clinical Research, Eli Lilly, Impulse Dynamics, Intellia Therapeutics, Ionis Pharmaceutical, Janssen Research & Development LLC, Medscape/WebMD Global LLC, Merck, Novartis, Novo Nordisk, Prosciento Inc, Quidel Corporation, Radcliffe Group Ltd., Recardio Inc, ReCor Medical, Roche Diagnostics, Sanofi, Siemens Healthcare Diagnostics and, Us2.ai; and is a co-founder and nonexecutive director of Us2.ai. Dr Senni has served on advisory boards for, as a consultant for, and has received honoraria from Novartis, Abbott, Merck, MSD, Vifor, AstraZeneca, Cardurion, Novo Nordisk, Bayer, and Boehringer Ingelheim. Dr Shah has received research grants from the NIH (U54 HL160273, X01 HL169712, R01 HL140731, R01 HL149423), AHA (24SFRNPCN1291224), AstraZeneca, Corvia, and Pfizer; and has received consulting fees from Abbott, Alleviant, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Imara, Impulse Dynamics, Intellia, Ionis, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, Regeneron, Rivus, Sardocor, Shifamed, Tenax, Tenaya, and Ultromics. Dr Voors’ employer received consultancy fees and/or research support from Adrenomed, Anacardio, AstraZeneca, Bayer AG, BMS, Boehringer Ingelheim, Corteria, EliLilly, Merck, Moderna, Novartis, Novo Nordisk, Roche diagnostics, and SalubrisBio. Dr Bauersachs received honoraria for lectures/consulting from Novartis, Vifor, Bayer, Pfizer, Boehringer Ingelheim, AstraZeneca, Cardior, CVRx, BMS, Amgen, Corvia, Norgine, Edwards, and Roche not related to this paper; and has received research support for the department from Zoll, CVRx, Abiomed, Norgine, and Roche, not related to this paper. Dr Zannad has received personal fees from 89Bio, Abbott, Acceleron, Applied Therapeutics, Bayer, Betagenon, Boehringer, BMS, CVRx, Cambrian, Cardior, Cereno pharmaceutical, Cellprothera, CEVA, Inventiva, KBP, Merck, NovoNordisk, Owkin, Otsuka, Roche Diagnostics, Northsea, USa2; has stock options at G3Pharmaceutical; has equity in Cereno, Cardiorenal, and Eshmoun Clinical research; and is the founder of Cardiovascular Clinical Trialists. Dr Pitt is a consultant for Bayer, AstraZeneca, Boehringer Ingelheim, Lexicon, Bristol Myers Squibb, KBP Biosciences∗, Sarfez Pharmaceuticals∗, Pharmaceuticals∗, SQinnovations∗, G3 Pharmaceuticals, Sea Star medical∗, Vifor∗ Prointel∗, and Brainstorm Medical; has stock options in KBP Biosciences, Sarfez Pharmaceuticals, Pharmaceuticals, SQinnovations, Sea Star medical, Vifor, Prointel, and Brainstorm Medical; and has U.S. Patent 9931412-site specific delivery of eplerenone to the myocardium, and U.S. Patent pending 63/045,783 Histone modulating agents for the prevention and treatment of organ failure. Dr Vaduganathan has received research grant support, served on advisory boards, or had speaker engagements with American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, BMS, Boehringer Ingelheim, Chiesi, Cytokinetics, Fresenius Medical Care, Idorsia Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Milestone Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; and participates on clinical trial committees for studies sponsored by AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. Dr Solomon has received research grants from Alexion, Alnylam, AstraZeneca, Bellerophon, Bayer, BMS, Boston Scientific, Cytokinetics, Edgewise, Eidos, Gossamer, GSK, Ionis, Lilly, MyoKardia, NIH/NHLBI, Novartis, Novo Nordisk, Respicardia, Sanofi Pasteur, Theracos, US2.AI; and has consulted for Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Boeringer Ingelheim, BMS, Cardior, Cardurion, Corvia, Cytokinetics, Daiichi-Sankyo, GSK, Lilly, Merck, Myokardia, Novartis, Roche, Theracos, Quantum Genomics, Janssen, Cardiac Dimensions, Tenaya, Sanofi-Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, and Valo. Dr McMurray has received payments through Glasgow University from work on clinical trials; has receviedconsulting and grants from Amgen, AstraZeneca, Bayer, Cardurion, Cytokinetics, GSK and Novartis, British Heart Foundation, National Institute for Health – National Heart, Lung, and Blood Institute (NIH-NHLBI), Boehringer Ingelheim, SQ Innovations, and Catalyze Group; has receivedpersonal consultancy fees from Alynylam Pharmaceuticals, Amgen, AnaCardio, AstraZeneca, Bayer, Berlin Cures, BMS, Cardurion, Cytokinetics, Ionis Pharmaceuticals, Novartis, Regeneron Pharmaceuticals, and River 2 Renal Corp; has received personal lecture fees from Abbott, Alkem Metabolics, Astra Zeneca, Blue Ocean Scientific Solutions Ltd., Boehringer Ingelheim, Canadian Medical and Surgical Knowledge, Emcure Pharmaceuticals Ltd., Eris Lifesciences, European Academy of CME, Hikma Pharmaceuticals, Imagica Health, Intas Pharmaceuticals, J.B. Chemicals & Pharmaceuticals Ltd, Lupin Pharmaceuticals, Medscape/Heart.Org., ProAdWise Communications, Radcliffe Cardiology, Sun Pharmaceuticals, The Corpus, Translation Research Group, and Translational Medicine Academy; and data safety monitoring board membership for WIRB-Copernicus Group Clinical Inc; andis a director of Global Clinical Trial Partners Ltd.All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
- Full Text
- View/download PDF
44. Rheumatic Valve Surgery in Sudan: Results in 7,449 Patients at the Salam Centre for Cardiac Surgery.
- Author
-
Portella G, Chatenoud L, Gatti S, Salvati AC, Asta L, Lentini S, Puntila J, Masini F, Redaelli S, Mocini A, Abdallah SA, Abdalla Abdalla SH, Erba N, Giovanella E, Raafat Shafig Saber D, Rocchi D, Badr Saad M, Valgoi L, Malerba P, Rolla L, Pesenti A, Latini R, Parrino P, Miccio R, and Langer M
- Abstract
Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
45. Transcatheter Aortic Valve Replacement in Heart Failure, Reduced Ejection Fraction, and Moderate Aortic Stenosis.
- Author
-
O'Gara PT
- Abstract
Competing Interests: Funding Support and Author Disclosures The author has reported that he has no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
46. 2-Fold More Cardiovascular Disease Events Decades Before Type 2 Diabetes Diagnosis: A Nationwide Registry Study.
- Author
-
Gyldenkerne C, Kahlert J, Thrane PG, Olesen KKW, Mortensen MB, Sørensen HT, Thomsen RW, and Maeng M
- Subjects
- Humans, Male, Female, Middle Aged, Denmark epidemiology, Aged, Case-Control Studies, Incidence, Time Factors, Prevalence, Cohort Studies, Adult, Risk Factors, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 diagnosis, Cardiovascular Diseases epidemiology, Cardiovascular Diseases diagnosis, Registries
- Abstract
Background: The risk of cardiovascular disease (CVD) is increased in individuals with type 2 diabetes mellitus (T2DM), but it remains uncertain how long an elevated CVD occurrence precedes diabetes diagnosis., Objectives: The aim of this study was to investigate CVD occurrence 30 years before, and 5 years after, T2DM diagnosis compared with matched comparisons., Methods: This combined case-control and cohort study included all individuals diagnosed with T2DM in Denmark between 2010 and 2015, as well as general population comparisons matched by age and sex. CVD was defined as myocardial infarction or ischemic stroke. Conditional logistic regression was used to compute ORs for CVD prevalence in the 30-year period before T2DM diagnosis. Cox proportional hazards regression models were used to compute HRs for 5-year CVD incidence after T2DM diagnosis., Results: The study included 127,092 individuals with T2DM and 381,023 matched comparisons. In the 30-year period before T2DM diagnosis, 14,179 (11.2%) T2DM individuals and 17,871 (4.7%) comparisons experienced CVD. CVD prevalence was higher in those with T2DM than the comparisons in the entire period before T2DM diagnosis, with ORs ranging from 2.18 (95% CI: 1.91-2.48) in the earliest period (25-30 years before diagnosis) to 2.96 (95% CI: 2.85-3.08) in the latest period (<5 years before diagnosis). After T2DM diagnosis, 5-year CVD incidence was similarly increased in T2DM individuals vs comparisons (HR: 2.20; 95% CI: 2.12-2.27)., Conclusions: Individuals with T2DM had 2-fold more CVD events than matched comparisons starting 3 decades before T2DM diagnosis. This indicates that comprehensive preventive strategies may be initiated much earlier in individuals at risk of T2DM., Competing Interests: Funding Support and Author Disclosures Dr Gyldenkerne is supported by a scholarship from Aarhus University. The funding source had no influence on the study design, conduct and interpretation of the data, or the decision to submit this manuscript for publication. Dr Maeng is supported by the Borregaard Clinical Ascending Investigator Research Grant financed by the Novo Nordisk Foundation (grant NNF22OC0074083); has received lecture and/or advisory board fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, and Novo Nordisk; has received research grants from Philips, Bayer, and Novo Nordisk; has received a travel grant from Novo Nordisk; has ongoing research contracts with Janssen, Novo Nordisk, and Philips; and is a minor shareholder in Eli Lilly & Company, Novo Nordisk, and Verve Therapeutics. The Department of Clinical Epidemiology, Aarhus University Hospital, receives funding for other studies from companies in the form of research grants to (and administered by) Aarhus University. Dr Olesen is supported by the Danish Cardiovascular Academy, which is funded by the Novo Nordisk Foundation (grant NNF20SA0067242) and The Danish Heart Foundation. None of these studies have any relation to the current study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
47. The "Ticking Clock" of Impending Diabetes: Cause for Concern or Window of Opportunity?
- Author
-
Sperling LS
- Abstract
Competing Interests: Funding Support and Author Disclosures The author has reported that he has no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
48. Length of Hospital Stay for Endocarditis Before and After the Partial Oral Treatment of Endocarditis Trial.
- Author
-
Østergaard L, Pries-Heje MM, Voldstedlund M, Bruun NE, Povlsen JA, Køber N, Ihlemann N, Tuxen C, Hasselbalch R, Jørgensen PG, Stahl A, Havers-Borgersen E, Petersen JK, Moser C, Køber L, Iversen K, Bundgaard H, and Fosbøl EL
- Subjects
- Humans, Male, Female, Aged, Denmark epidemiology, Middle Aged, Administration, Oral, Bacteremia drug therapy, Bacteremia mortality, Registries, Recurrence, Aged, 80 and over, Length of Stay statistics & numerical data, Endocarditis, Bacterial drug therapy, Endocarditis, Bacterial mortality, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents administration & dosage
- Abstract
Background: The results from the POET (Partial Oral Treatment of left-sided Endocarditis) trial were published in August 2018 and established noninferiority of oral step-down antibiotic treatment in stabilized patients with infective endocarditis (IE). Data on length of hospital stay (LOS) and safety following the POET trial are warranted., Objectives: The goal of this study was to examine changes in LOS and safety (mortality and relapse of bacteremia) before and after POET publication., Methods: Using Danish nationwide registries, patients with first-time IE caused by Streptococcus spp., Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci from 2012 to 2021 were identified. Median LOS was examined according to publication date (before and after September 2018). Mortality and relapse of bacteremia at 180 days of follow-up were examined., Results: We identified 3,008 patients before POET publication (median age 72.8 years) and 1,740 after publication (median age 75.2 years) (P < 0.0001). The median LOS decreased by 8 days: 41 days (Q1-Q3: 29-49 days) before POET publication and 33 days (Q1-Q3: 21-44 days) after POET publication (P < 0.0001). Similar reductions in LOS were seen across microbiological etiologies and age groups. Reduction in LOS was most pronounced in nonsurgically treated patients. Mortality from IE admission to a maximum of 180 days' follow-up was 27.5% before POET publication and 28.3% after publication (P = 0.41). The bacteremia relapse rate within 180 days was 3.5% before POET publication and 1.6% after publication (P = 0.0002)., Conclusions: Following the POET trial, we found a reduction in median LOS of 8 days with no change in mortality and an associated lower rate of relapse of bacteremia., Competing Interests: Funding Support and Author Disclosures Dr Østergaard has received an independent research grant from the Novo Nordisk Foundation for the research of mitral valve regurgitation. Dr Bundgaard has received lecture fees from Amgen, Sanofi, Bristol Myers Squibb, and Merck Sharp and Dohme. Dr Bruun has received investigator initiated grants from Novo Nordisk Foundation, The Augustinus Foundation, The Kaj Hansen Foundation, and Health Insurance Denmark, not related to this study. Dr Køber has received speaker fees from Boehringer Ingelheim. Dr Jørgensen has received lecture fees from AstraZeneca. Dr Tuxen has received speaker fees from Orion Pharma and Novartis; and has received personal fees for advisory board participation from Boehringer Ingelheim and Bayer A/S, all outside the submitted work. Dr Moser is supported by the Novo Nordisk Foundation-“Borregaard Clinical Scientist Grant” (Grant No. NNF17OC0025074); and has received lecture fees from GlaxoSmithKline, AstraZeneca, and Boehringer Ingelheim. Dr Køber has received speakers honorarium from Novo, Novartis, AstraZeneca, Boehringer, and Bayer. Dr Fosbøl has received independent research grants from the Novo Nordisk Foundation and the Danish Heart Association related to valvular heart disease and endocarditis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
49. Using Electrocardiogram to Assess Diastolic Function and Prognosis in Mitral Regurgitation.
- Author
-
Tsaban G, Lee E, Wopperer S, Abbasi M, Yu HT, Kane GC, Lopez-Jimenez F, Pislaru SV, Nkomo VT, Deshmukh AJ, Asirvatham SJ, Noseworthy PA, Friedman PA, Attia Z, and Oh JK
- Subjects
- Humans, Female, Male, Aged, Retrospective Studies, Prognosis, Middle Aged, Echocardiography methods, Ventricular Function, Left physiology, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency mortality, Mitral Valve Insufficiency diagnosis, Electrocardiography methods, Diastole
- Abstract
Background: The determination of left ventricular diastolic function (LVDF) in patients with significant (≥moderate) mitral regurgitation (MR) poses a complex challenge. We recently validated an artificial intelligence-enabled electrocardiogram (AI-ECG) algorithm to estimate LVDF., Objectives: This study sought to evaluate the risk of all-cause mortality across AI-ECG LVDF-derived myocardial disease (MD) grades in MR., Methods: This was a retrospective study including all patients in the AI-ECG LVDF study testing group who underwent comprehensive transthoracic echocardiography confirming significant MR and electrocardiogram within 14 days of each other at the Mayo Clinic between September 2001 and April 2023. AI-ECG LVDF status was determined based on the index electrocardiogram and used to categorize patients into 3 stages of MD: MD-1, normal or grade 1 LVDF; MD-2, grade 2 LVDF; and MD-3, grade 3 LVDF., Results: Of 4,019 patients with significant MR (mean age 69.8 years; 49.0% women), 1,175 (29.2%), 1,881 (46.8%), and 963 (24.0%) were classified by AI-ECG as MD-1, MD-2, and MD-3, respectively. The median mitral effective regurgitant orifice area was 26 mm
2 (Q1-Q3: 20-36 mm2 ). Over a median follow-up of 3.5 years, 1,636 (40.7%) patients died. In multivariable survival analysis adjusted for multiple risk factors, a higher diastolic function grade was independently associated with an increased death risk (MD-2, adjusted HR [aHR]: 1.99; 95% CI: 1.62-2.45; MD-3, aHR: 2.65; 95% CI: 2.11-3.34). These findings were consistent when accounting for mitral valve intervention and across various sensitivity and subgroup analyses., Conclusions: In patients with significant MR, the grading of LVDF by AI-ECG is independently associated with all-cause mortality., Competing Interests: Funding Support and Author Disclosures This work was funded by the Mayo Clinic. This work was partly supported by the David M.C. Ju Foundation, a nonprofit organization. The study's funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Drs Lee, Lopez-Jimenez, Friedman, and Attia Oh have invented algorithms licensed to ANUMANA and may benefit from algorithm commercialization via Mayo Clinic. Drs Lopez-Jimenez, Asirvatham, Friedman, and Attia have served on the scientific advisory board for ANUMANA. Dr Oh has served as a consultant for Medtronic's valve projects. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
- Full Text
- View/download PDF
50. Endocarditis Therapy: The Move From Expert Opinion to Evidence.
- Author
-
Spellberg B, Lee TC, Ghanem B, and McDonald EG
- Abstract
Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2024
- Full Text
- View/download PDF
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.