Journal: Am Heart J

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Abstract

Comparative effectiveness of empagliflozin in reducing the burden of recurrent cardiovascular hospitalizations among older adults with diabetes in routine clinical care.

Desai RJ, Glynn RJ, Everett BM, Schneeweiss S, ... Brodovicz K, Patorno E
Background
The effect of sodium glucose cotransporter 2 inhibitors (SGLT2i) on the total (first and recurrent) burden of cardiovascular (CV) hospitalizations, including hospitalization for heart failure, myocardial infarction, and stroke, is poorly understood.
Objective
To assess the effect of empagliflozin, an SGLT2i, on total CV hospitalizations among older adults with T2D.
Methods
Using data from Medicare fee-for-service (08/2014-09/2017), we identified 1:1 propensity score-matched cohorts of patients with T2D initiating empagliflozin versus sitagliptin or empagliflozin versus glucagon-like peptide-1 receptor agonists (GLP-1RA), balancing >140 baseline covariates. We compared the risk of first and recurrent hospitalizations with any CV condition as the primary discharge diagnosis (ICD-9: 390-459; ICD-10: I00-I99), hospitalizations for heart failure (HHF), and myocardial infarctions (MI) or stroke. We estimated treatment effects based on the Ghosh-Lin semiparametric model for recurrent events as primary and joint frailty model as secondary analysis.
Results
We included 11,429 matched-pairs of empagliflozin and sitagliptin initiators and 17,502 matched-pairs of empagliflozin and GLP1-RA initiators with an average age of 72 years. Empagliflozin was associated with a reduced risk of total CV hospitalizations (0.80 [0.69-0.93] vs sitagliptin; 0.88 [0.77-1.00] vs GLP-1RA) and total HHF (0.70 [0.51-0.98] vs sitagliptin; 0.76 [0.56-1.03] vs GLP1-RA) over a mean follow up of 6.3 months. No differences between treatments were observed for MI or stroke. Results were consistent for joint frailty models.
Conclusion
Empagliflozin, compared to sitagliptin or to a lesser extent GLP1-RA, was associated with a reduction in the burden of total CV hospitalizations and HHF in older patients with T2D.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 20 Sep 2022; epub ahead of print
Desai RJ, Glynn RJ, Everett BM, Schneeweiss S, ... Brodovicz K, Patorno E
Am Heart J: 20 Sep 2022; epub ahead of print | PMID: 36150454
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Abstract

Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA): Rationale and Design for a Randomized Controlled Trial.

Baldridge AS, Huffman MD, Lazar D, Abbas H, ... Chow CK, Ciolino JD
Background
Over half of patients with elevated blood pressure require multi-drug treatment to achieve blood pressure control. However, multi-drug treatment may lead to lower adherence and more adverse drug effects compared with monotherapy.
Objective
The Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET) USA trial was designed to evaluate whether initiating treatment with ultra-low-dose quadruple-combination therapy will lower office blood pressure more effectively, and with fewer side effects, compared with initiating standard dose monotherapy in patients with SBP < 160 and DBP < 100 mm Hg.
Methods/design
QUARTET USA was a prospective, randomized, double-blind trial (ClinicalTrials.gov NCT03640312) conducted in federally qualified health centers in a large city in the US. Patients were randomly assigned (1:1) to either ultra-low-dose quadruple combination therapy or standard dose monotherapy. The primary outcome was mean change from baseline in office systolic blood pressure at 12-weeks, adjusted for baseline values. Secondary outcomes included measures of blood pressure change and variability, medication adherence, and health related quality of life. Safety outcomes included occurrence of serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. A process evaluation aimed to understand provider experiences of implementation and participant experiences around side effects, adherence, and trust with clinical care.
Discussion
QUARTET USA was designed to evaluate whether a novel approach to blood pressure control would lower office blood pressure more effectively, and with fewer side effects, compared with standard dose monotherapy. QUARTET USA was conducted within a network of federally qualified healthcare centers with the aim of generating information on the safety and efficacy of ultra-low-dose quadruple-combination therapy in diverse groups that experience a high burden of hypertension.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 15 Sep 2022; epub ahead of print
Baldridge AS, Huffman MD, Lazar D, Abbas H, ... Chow CK, Ciolino JD
Am Heart J: 15 Sep 2022; epub ahead of print | PMID: 36116516
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Abstract

Insights into the genetic architecture underlying complex, critical congenital heart disease.

Blue GM, Ip EKK, Troup M, Dale RC, ... Giannoulatou E, Winlaw DS
Congenital heart disease (CHD) has a multifactorial aetiology, raising the possibility of an underlying genetic burden, predisposing to disease but also variable expression, including variation in disease severity, and incomplete penetrance. Using whole genome sequencing (WGS), the findings of this study, indicate that complex, critical CHD is distinct from other types of disease due to increased genetic burden in common variation, specifically among established CHD genes. Additionally, these findings highlight associations with regulatory genes and environmental \'stressors\' in the final presentation of disease.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 14 Sep 2022; epub ahead of print
Blue GM, Ip EKK, Troup M, Dale RC, ... Giannoulatou E, Winlaw DS
Am Heart J: 14 Sep 2022; epub ahead of print | PMID: 36115390
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Abstract

Aortic valve neocuspidization using the Ozaki technique: A meta-analysis of reconstructed patient-level data.

Mylonas KS, Tasoudis PT, Pavlopoulos D, Kanakis M, Stavridis GT, Avgerinos DV
Background
Aortic valve neocuspidization using the Ozaki technique has shown promising results both in adults and children.
Methods
A systematic search of the PubMed and Cochrane databases was performed up to November 13th, 2021. Individual patient data were reconstructed and analyzed from the Kaplan-Meier curves of all eligible studies for time-to-event outcomes.
Results
We included a total of 22 studies reporting on 1,891 patients that underwent Ozaki reconstruction. Mean age at the time of surgery was 43.2 ± 24.5 years (65 ± 12.3 years for adult patients and 12.3 ± 3.8 years for pediatric patients). The most common indication was aortic stenosis (46.4%, 95% CI 34.1 - 58.6). Mean cross-clamp and cardiopulmonary bypass duration were 106.8 ± 24.8 min and 135.2 ± 35.1 min, respectively. Permanent pacemaker was implanted in 0.7% (95% CI 0.4 - 1.2) of the patients. At discharge, mean effective orifice area was 2.1 ± 0.5cm2/m2. At latest follow up, peak gradient was 15.7 ± 7.4 mmHg and only 0.25% (95% CI 0 - 2.3) had moderate aortic insufficiency. In-hospital mortality was 0.7% (95% CI 0.1-1.7). Late mortality was 1.9% during a mean follow up of 38.1 ± 23.8 months. One-year, three-year, and five-year freedom from reoperation rates were 98.0 %, 97.0 % and 96.5%, respectively. More than half of the reoperations were due to infective endocarditis (51.5%, 95% CI 18.3 - 84.0). In our cohort, the risk of endocarditis per patient per year was 0.5%.
Conclusions
The midterm outcomes of the Ozaki procedure are excellent in terms of hemodynamics, survival, and freedom from reoperation. Acquiring long-term follow-up will help solidify this technique in the cardiac surgery armamentarium.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 14 Sep 2022; epub ahead of print
Mylonas KS, Tasoudis PT, Pavlopoulos D, Kanakis M, Stavridis GT, Avgerinos DV
Am Heart J: 14 Sep 2022; epub ahead of print | PMID: 36115391
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Abstract

The Pediatric Heart Network\'s Study on Long-term Outcomes of Children with HLHS and the Impact of Norwood Shunt Type in the Single Ventricle Reconstruction Trial Cohort (SVRIII): Design and Adaptations.

Goldberg CS, Gaynor JW, Mahle WT, Ravishankar C, ... Newburger JW, Pediatric Heart Network Investigators
Background
The Single Ventricle Reconstruction (SVR) Trial was the first randomized clinical trial of a surgical approach for treatment of congenital heart disease. Infants with hypoplastic left heart syndrome (HLHS) and other single right ventricle (RV) anomalies were randomized to a modified Blalock Taussig Thomas shunt (mBTTS) or a right-ventricular-to-pulmonary-artery shunt (RVPAS) at the time of the Norwood procedure. The aim of the Long-term Outcomes of Children with HLHS and the Impact of Norwood Shunt Type (SVR III) study is to compare early adolescent outcomes including measures of cardiac function, transplant-free survival, and neurodevelopment, between those who received a mBTTS and those who received an RVPAS.
Methods
Transplant-free survivors of the SVR cohort were enrolled at 10-15 years of age for multifaceted in-person evaluation of cardiac function (cardiac magnetic resonance [CMR], echocardiogram and exercise test) and neurodevelopmental evaluation. Right ventricular ejection fraction measured by CMR served as the primary outcome. Development of arrhythmias, protein losing enteropathy, and other comorbidities were assessed through annual medical history interview. Through the course of SVR III, protocol modifications to engage SVR trial participants were designed to enhance recruitment and retention.
Conclusions
Evaluation of long-term outcomes will provide important data to inform decisions about the shunt type placed at the Norwood operation and will improve the understanding of cardiovascular and neurodevelopmental outcomes for early adolescents with HLHS.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 14 Sep 2022:6621; epub ahead of print
Goldberg CS, Gaynor JW, Mahle WT, Ravishankar C, ... Newburger JW, Pediatric Heart Network Investigators
Am Heart J: 14 Sep 2022:6621; epub ahead of print | PMID: 36115392
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Abstract

Rate versus Rhythm Control in Patients with Newly Diagnosed Atrial Fibrillation: Effects of the Treatment Timing on Health Status Outcomes.

Nakamaru R, Ikemura N, Spertus JA, Kimura T, ... Takatsuki S, Kohsaka S
Background
Recent randomized clinical trials have demonstrated that applying rhythm control during the early stage of atrial fibrillation (AF) may lead to improved clinical outcomes. However, the effects of this modality on health-related quality of life (HRQoL) have not been fully investigated. We aimed to assess the association between AF stage, determined by the time between AF diagnosis and referral to the cardiology clinic, and HRQoL outcomes.
Methods
Using an outpatients-based multicenter AF registry (n=3,313), we analyzed 2,070 patients with AF diagnosed within 5 years. The patients were divided into two groups according to AF stage: early and late AF (AF duration ≤1 and >1 year, respectively). All patients had HRQoL information collected at baseline and 1 year after their initial treatment (assessed via the Atrial Fibrillation Effect on Quality-of-Life-overall summary [AFEQT-OS] score, with higher scores reflecting better HRQoL). The change in AFEQT-OS was adjusted for patient characteristics using a generalized linear mixed model.
Results
The early AF group (n=1,644) was older (early, 68.5 ± 11.1, late, 64.4 ± 10.6 years, p<.001) and had more heart failure (early, 19.9%, late, 12.7%, p<.001) than the late AF group (n=426). At 1 year after treatment, the adjusted changes in AFEQT-OS were similar in patients with rhythm (adjusted difference [SE], early, 8.4 [1.2], late, 7.2 [1.4], p=.15) or rate (early, 4.0 [0.7], late, 2.3 [1.4], p=.16) control, regardless of AF stage. Furthermore, the improvement in HRQoL was similar between early and late AF in patients undergoing catheter ablation (early, 10.2 [2.1], late, 9.8 [2.4], p=.78), whereas a significant difference was observed in those receiving antiarrhythmic drug therapy alone (early, 10.2 [1.4], late, 3.5 [2.2], p<.001).
Conclusions
Rhythm control therapy provided clinically meaningful improvements in HRQoL, regardless of AF stage. For patients with impaired HRQoL, AF duration should not be a deterrent to treatment, especially catheter ablation.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 10 Sep 2022; epub ahead of print
Nakamaru R, Ikemura N, Spertus JA, Kimura T, ... Takatsuki S, Kohsaka S
Am Heart J: 10 Sep 2022; epub ahead of print | PMID: 36099976
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Abstract

Personalized approach using wearable technology for early detection of Atrial Fibrillation in high-risk primary care patients (PATCH-AF): study protocol for a cluster randomized controlled trial.

Brik T, Lucassen WAM, Harskamp RE, Karregat EPM, ... Busschers WB, van Charante EPM
Background
Atrial fibrillation (AF) is a common cardiac arrhythmia with a lifetime risk of one in four. Unfortunately, AF often remains undetected, particularly when it is paroxysmal, for which single time-point evaluation is less effective. Recently, unobtrusive cardiac arrhythmia monitoring devices have become available, providing the opportunity to conduct prolonged electrocardiographic (ECG) monitoring in a patient-friendly manner. We hypothesize that applying these devices in at risk patients may improve AF detection, particularly when used during repeated episodes. We therefore aim to evaluate the diagnostic yield of yearly screening for atrial fibrillation when using a wearable device for continuous ECG monitoring for 7 days in primary care patients ≥ 65 years deemed at high risk of AF (CHA2DS2VASc score ≥3 for men or ≥ 4 for women) compared with usual care over a study period of three years.
Methods
Primary care based, cluster-randomized controlled trial with 10 general practices randomized to the intervention group and 10 general practices randomized to control group. In each group, we aim to enroll 930 patients, ≥65 years and a CHA2DS2VASc score ≥3 for men or ≥ 4 for women. The intervention consists of continuous ECG monitoring for 7 days at start of the study (t=0), after one (t=1) and two years (t=2). The control practices will follow usual diagnostic care procedures.
Conclusion
This study differs from previous RCTs, as it involves longitudinal screening of a risk-stratified population. In case of a beneficial diagnostic yield, the PATCH-AF study will add to the evidence for AF screening.
Trial registration
The PATCH-AF study is registered at The Netherlands Trial Register (NTR number NL9656).

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 10 Sep 2022; epub ahead of print
Brik T, Lucassen WAM, Harskamp RE, Karregat EPM, ... Busschers WB, van Charante EPM
Am Heart J: 10 Sep 2022; epub ahead of print | PMID: 36099977
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Abstract

Development of a Unified National Database of Primary Percutaneous Coronary Intervention Centers with Co-located Emergency Departments, 2020.

Herscovici DM, Boggs KM, Cash RE, Espinola JA, ... Nagurney JT, Camargo CA
Background
Although primary percutaneous coronary intervention (pPCI) is the preferred intervention for ST-elevation myocardial infarction (STEMI), not all patients are admitted directly to an emergency department (ED) with 24/7/365 pPCI capabilities. This is partly due to a lack of a national system of known pPCI-capable EDs. Our objective was to create a unified, national database of confirmed 24/7/365 pPCI centers co-located in hospitals with EDs.
Methods
We compiled all hospitals designated as Chest Pain Centers with Primary PCI by the American College of Cardiology\'s (ACC) National Clinical Data Registry (NCDR), all STEMI Receiving Centers designated by the American Heart Association\'s (AHA) Mission: Lifeline registry, and all state-designated pPCI-capable hospitals and designation criteria from state departments of health. We matched ACC, AHA, and state-designated facilities to those in the 2019 National ED Inventory (NEDI)-USA database to identify all EDs in pPCI-capable hospitals.
Results
Overall, 467 hospitals were recognized as Chest Pain Centers with Primary PCI by ACC, 293 hospitals were recognized as being STEMI Receiving Centers by AHA, and 827 hospitals were confirmed to be pPCI-capable by state designations and operated 24/7/365. Together, there were 1,178 EDs (21% of 5,587 total) co-located in pPCI-capable hospitals operating 24/7/365.
Conclusion
There is substantial heterogeneity in cardiac systems of care, with large regional systems existing alongside local state-led initiatives. We created a unified national database of confirmed 24/7/365 pPCI centers co-located in hospitals with EDs. This dataset will be valuable for future cardiac systems research and improving access to pPCI.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 10 Sep 2022; epub ahead of print
Herscovici DM, Boggs KM, Cash RE, Espinola JA, ... Nagurney JT, Camargo CA
Am Heart J: 10 Sep 2022; epub ahead of print | PMID: 36099978
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Abstract

Primary Left Ventricular Unloading with Delayed Reperfusion in Patients with Anterior ST-Elevation Myocardial Infarction: Rationale and Design of the STEMI-DTU Randomized Pivotal Trial.

Kapur NK, Kim RJ, Moses JW, Stone GW, ... Polak SJ, Neill WWO
Background
Despite successful primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI), myocardial salvage is often suboptimal, resulting in large infarct size and increased rates of heart failure and mortality. Unloading of the left ventricle (LV) before primary PCI may reduce infarct size and improve prognosis.
Study design and objectives
STEMI-DTU (NCT03947619) is a prospective, randomized, multicenter trial designed to compare mechanical LV unloading with the Impella CP device for 30 minutes prior to primary PCI to primary PCI alone without LV unloading. The trial aims to enroll approximately 668 subjects, with a potential sample size adaptation, with anterior STEMI with a primary endpoint of infarct size as a percent of LV mass evaluated by cardiac magnetic resonance at 3-5 days after PCI. The key secondary efficacy endpoint is a hierarchical composite of the 1-year rates of cardiovascular mortality, cardiogenic shock ≥24 hours after PCI, use of a surgical left ventricular assist device or heart transplant, heart failure, intra-cardiac defibrillator or chronic resynchronization therapy placement, and infarct size at 3-5 days post-PCI. The key secondary safety endpoint is Impella CP-related major bleeding or major vascular complications within 30 days. Clinical follow-up is planned for 5 years.
Conclusions
STEMI-DTU is a large-scale, prospective, randomized trial evaluating whether mechanical unloading of the LV by the Impella CP prior to primary PCI reduces infarct size and improves prognosis in patients with STEMI compared to primary PCI alone without LV unloading.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 01 Sep 2022; epub ahead of print
Kapur NK, Kim RJ, Moses JW, Stone GW, ... Polak SJ, Neill WWO
Am Heart J: 01 Sep 2022; epub ahead of print | PMID: 36058253
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Abstract

CHARACTERIZATION OF ARRHYTHMIA SUBSTRATE TO ABLATE PERSISTENT ATRIAL FIBRILLATION (COAST-AF): RANDOMIZED CONTROLLED TRIAL DESIGN AND RATIONALE.

Nery PB, Wells GA, Verma A, Joza J, ... Sturmer M, Birnie D
Background
Atrial low voltage area (LVA) catheter ablation has emerged as a promising strategy for ablation of persistent atrial fibrillation (AF). It is unclear if catheter ablation of atrial LVA increases treatment success rates in patients with persistent AF.
Objective
The primary aim of this trial is to assess the potential benefit of adjunctive catheter ablation of atrial LVA in addition to pulmonary vein isolation (PVI) in patients with persistent AF, when compared to PVI alone. The secondary aims are to evaluate safety outcomes, quality of life and healthcare resource utilization.
Methods/design
A multicenter, prospective, parallel-group, two-arm, single-blinded randomized controlled trial is under way (NCT03347227). Patients who are candidates for catheter ablation for persistent AF will be randomly assigned (1:1) to either PVI alone or PVI + atrial LVA ablation. The primary outcome is 18-month documented event rate of atrial arrhythmia (AF, atrial tachycardia or atrial flutter) post catheter ablation. Secondary outcomes include procedure-related complications, freedom from atrial arrhythmia at 12 months, AF burden, need for emergency department visits/hospitalization, need for repeat ablation for atrial arrhythmia, quality of life at 12 and 18 months, ablation time, and procedure duration.
Discussion
Characterization of Arrhythmia Mechanism to Ablate Atrial Fibrillation (COAST-AF) is a multicenter randomized trial evaluating ablation strategies for catheter ablation. We hypothesize that catheter ablation of atrial LVA in addition to PVI will result in higher procedural success rates when compared to PVI alone in patients with persistent AF.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 25 Aug 2022; epub ahead of print
Nery PB, Wells GA, Verma A, Joza J, ... Sturmer M, Birnie D
Am Heart J: 25 Aug 2022; epub ahead of print | PMID: 36030965
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Abstract

Machine Learning to Define Phenotypes and Outcomes of Patients Hospitalized for Heart Failure with Preserved Ejection Fraction: Findings from ASCEND-HF.

Murray EM, Greene SJ, Rao VN, Sun JL, ... Ahmad T, Mentz RJ
Background
Heart Failure with Preserved Ejection Fraction (HFpEF) is a heterogenous disease with few therapies proven to provide clinical benefit. Machine learning can characterize distinct phenotypes and compare outcomes among patients with HFpEF who are hospitalized for acute HF.
Methods
We applied hierarchical clustering using demographics, comorbidities, and clinical data on admission to identify distinct clusters in hospitalized HFpEF (ejection fraction >40%) in the ASCEND-HF trial. We separately applied a previously developed latent class analysis (LCA) clustering method and compared in-hospital and long-term outcomes across cluster groups.
Results
Of 7141 patients enrolled in the ASCEND-HF trial, 812 (11.4%) were hospitalized for HFpEF and met the criteria for complete case analysis. Hierarchical Cluster 1 included older women with atrial fibrillation (AF). Cluster 2 had elevated resting blood pressure. Cluster 3 had young men with obesity and diabetes. Cluster 4 had low resting blood pressure. Mortality at 180 days was lowest among Cluster 3 (KM event-rate 6.2 [95% CI: 3.5, 10.9]) and highest among Cluster 4 (18.8 [14.6, 24.0], p<0.001). Twenty four-hour urine output was higher in Cluster 3 (2700 mL [1800, 3975]) than Cluster 4 (2100 mL [1400, 3055], p<0.001). LCA also identified four clusters: A) older White or Asian women, B) younger men with few comorbidities, C) older individuals with AF and renal impairment, and D) patients with obesity and diabetes. Mortality at 180 days was lowest among LCA Cluster B (KM event-rate 5.5 [2.0, 10.3]) and highest among LCA Cluster C (26.3 [19.2, 35.4], p<0.001).
Conclusions
In patients hospitalized for HFpEF, cluster analysis demonstrated distinct phenotypes with differing clinical profiles and outcomes.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 22 Aug 2022; epub ahead of print
Murray EM, Greene SJ, Rao VN, Sun JL, ... Ahmad T, Mentz RJ
Am Heart J: 22 Aug 2022; epub ahead of print | PMID: 36007566
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Abstract

Development and Validation of an Automated Algorithm for Endpoint Adjudication for a Large U.S. National Registry: Short Title: Automated Adjudication Algorithm.

Friedman DJ, Pierre D, Wang Y, Gambone L, ... Curtis JP, Freeman JV
Background
Clinical events committee(CEC) evaluation is the standard approach for endpoint adjudication in clinical trials. Due to resource constraints, large registries typically rely on site-reported endpoints without further confirmation, which may preclude use for regulatory oversight.
Methods
We developed a novel automated adjudication algorithm(AAA) for endpoint adjudication in the NCDR Left Atrial Appendage Occlusion(LAAO) Registry using an iterative process using CEC adjudication as the \"gold standard.\" A ≥80% agreement rate between automated algorithm adjudication and CEC adjudication was prespecified as clinically acceptable. Agreement rates were calculated.
Results
A total of 92 in-hospital and 127 post-discharge endpoints were evaluated between January 1, 2016 and June 30, 2019 using AAA and CEC. Agreement for neurologic events was >90%. Percent agreement for in-hospital and post-discharge events was as follows: ischemic stroke 95.7% and 94.5%, hemorrhagic stroke 97.8% and 96.1%, undetermined stroke 97.8% and 99.2%, transient ischemic attack 98.9% and 98.4% and intracranial hemorrhage 100.0% and 94.5%. Agreement was >80% for major bleeding (83.7% and 90.6%) and major vascular complication (89.1% and 97.6%). With this approach, <1% of site reported endpoints require CEC adjudication. Agreement remained very good during the period after algorithm derivation.
Conclusions
An AAA-guided approach for endpoint adjudication was successfully developed and validated for the LAAO Registry. With this approach, the need for formal CEC adjudication was substantially reduced, with accuracy maintained above an 80% agreement threshold. After application specific validation, these methods could be applied to large registries and clinical trials to reduce the cost of event adjudication while preserving scientific validity.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 22 Aug 2022; epub ahead of print
Friedman DJ, Pierre D, Wang Y, Gambone L, ... Curtis JP, Freeman JV
Am Heart J: 22 Aug 2022; epub ahead of print | PMID: 36007567
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Abstract

Rationale and design for the study of recombinant human hepatocyte growth factor plasmid in the treatment of patients with chronic limb-threatening ischemia (HOPE CLTI): randomized, placebo-controlled, double-blind, phase III clinical trials.

Di X, Liu C, Ni L, Ye W, ... Han C, Liu Y
Background
Although patients with CLTI have benefited from the rapid development of endovascular techniques, many patients are considered unsuitable for revascularization procedures. A previous phase II clinical trial has suggested that recombinant human hepatocyte growth factor plasmid (NL003) can salvage limbs during the treatment of patients with CLTI. However, the safety and efficacy of this drug need to be evaluated in a larger cohort.
Study design
HOPE CLTI is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of intramuscular injection of NL003 in CLTI patients. This study consisted of two trials: HOPE CLTI-1, which includes patients with rest pain (Rutherford stage 4), and HOPE CLTI-2, which includes patients with limb ulcers (Rutherford stage 5). In both trials, patients are randomized with a 2:1 ratio of intramuscular injection of NL003 to placebo. The primary endpoint of HOPE CLTI-1 is the complete pain relief rate. The primary endpoint of HOPE CLTI-2 is the complete ulcer healing rate. The safety endpoint was assessed based on adverse events after injection of NL003. Enrollment began in July 2019. The HOPE CLTI-1 trial aims to complete the randomization of at least 300 patients, while the HOPE CLTI-2 trial aims to enroll at least 240 patients. Both trials are organized such that patients will be followed for six months after the first intramuscular injection.
Conclusions
HITOP CLTI, which is comprised of two multicenter, double-blind, placebo-controlled phase III clinical trials, aims to evaluate the efficacy and safety of the intramuscular administration of NL003 in patients with CLTI.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 21 Aug 2022; epub ahead of print
Di X, Liu C, Ni L, Ye W, ... Han C, Liu Y
Am Heart J: 21 Aug 2022; epub ahead of print | PMID: 36002048
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Abstract

Association of Change in QRS Duration with Chronic Heart Failure Outcomes.

Perry AS, Li S
QRS duration is an established risk factor among patients with heart failure (HF). How change in QRS duration relates to HF outcomes has had limited study. In this post-hoc analysis of the BEST trial, we demonstrated that QRS duration change from baseline to 3 months is independently associated with long-term survival and left ventricle ejection fraction.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am Heart J: 21 Aug 2022; epub ahead of print
Perry AS, Li S
Am Heart J: 21 Aug 2022; epub ahead of print | PMID: 36002049
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Abstract

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock - Design and Rationale of the CAPITAL MINOS Trial.

Parlow S, Di Santo P, Jung RG, Fam N, ... Simard T, Hibbert B
Background
Functional mitral regurgitation (MR) is an important clinical consideration in patients with heart failure. Transcatheter edge-to-edge repair (TEER) has emerged as a useful therapeutic tool for patients with chronic heart failure, however the role of TEER in patients with cardiogenic shock (CS) and MR has not yet been studied in a randomized trial. The Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock (CAPITAL MINOS) trial was therefore designed to determine if TEER improves clinical outcomes in the CS population.
Methods and design
The CAPITAL MINOS trial is an open-label, multi-center randomized clinical trial comparing TEER to medical therapy in patients with CS and MR. A total of 144 patients with Society for Cardiovascular Angiography and Interventions (SCAI) class C or D CS and at least 3+ MR will be randomized in a 1:1 ratio to TEER or medical therapy alone. The primary outcome will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable left ventricular assist device, or discharge on palliative inotropic therapy. Patients will be followed for the duration of their index hospitalization for the primary outcome. Secondary outcomes include 6-month mortality.
Implications
The CAPITAL MINOS trial will determine whether TEER improves outcomes in patients with CS and MR and will be an important step in optimizing treatment for this high-risk patient population.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 21 Aug 2022; epub ahead of print
Parlow S, Di Santo P, Jung RG, Fam N, ... Simard T, Hibbert B
Am Heart J: 21 Aug 2022; epub ahead of print | PMID: 36002047
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Abstract

Association Between Nitric Oxide Synthase 3 Genetic Variant and Acute Kidney Injury Following Pediatric Cardiac Surgery.

Kikano S, Breeyear J, Aka I, Edwards TL, Van Driest SL, Kannankeril PJ
Background
Acute kidney injury (AKI) complicates 30-50% of cardiac surgeries in pediatric patients. Genetic variants that affect renal blood flow and inflammation have been associated with AKI after cardiac surgery in diverse populations of adults but have not been studied in children. The objective of this study is to test the hypothesis that common candidate genetic variants are associated with AKI following pediatric cardiac surgery.
Methods
This is a retrospective cohort study at a single tertiary referral children\'s hospital of 2,062 individual patients undergoing surgery for congenital heart disease from September 2007 to July 2020. Pre-specified variants in candidate genes (AGTR1, APOE, IL6, NOS3, and TNF) were chosen. AKI was defined using Kidney Disease: Improving Global Outcomes serum creatinine criteria in the first week following surgery. Outcomes were analyzed by univariate and multivariable analysis of demographic, clinical, and genetic factors.
Results
The study population had median age of 6 (interquartile range [IQR], 1-53) months, 759 (37%) of whom met criteria for post-operative AKI. In unadjusted analyses of each genetic variant, only NOS3 (rs2070744) was associated with lower risk for AKI (OR 0.75, 95% CI 0.62-0.9, P=0.002). In logistic regression analyses adjusting for body surface area, previously identified genetic syndrome, Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score, cardiopulmonary bypass time, and nephrotoxic medication exposure, the NOS3 variant remained protective against AKI (OR 0.7, 95% CI 0.58-0.85, P<0.001).
Conclusion
A common variant in NOS3 is associated with decreased incidence of AKI in children undergoing cardiac surgery. Further analysis of the genetic contributions to postoperative AKI may help identify individual risk in the pediatric population.

Copyright © 2022 Elsevier Ltd. All rights reserved.

Am Heart J: 18 Aug 2022; epub ahead of print
Kikano S, Breeyear J, Aka I, Edwards TL, Van Driest SL, Kannankeril PJ
Am Heart J: 18 Aug 2022; epub ahead of print | PMID: 35988586
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Abstract

CYP2C19 genotype-guided antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease: study design of a randomized controlled trial (GENPAD).

Kranendonk J, Willems LH, Vijver-Coppen RV, Coenen M, ... Kramers C, Warlé MC
Background
Clopidogrel is recommended in international guidelines to prevent arterial thrombotic events in patients with peripheral arterial disease (PAD). Clopidogrel itself is inactive and metabolism is dependent on the CYP2C19 enzyme. About 30% of Caucasian PAD patients receiving clopidogrel carry one or two CYP2C19 loss-of-function allele(s) and do not or to a limited extent convert the prodrug into its active metabolite. As a result, platelet inhibition may be inadequate which could lead to an increased risk of adverse clinical events related to arterial thrombosis. A CYP2C19 genotype-guided antithrombotic treatment might be beneficial for PAD patients.
Methods
GENPAD is a multicenter randomized controlled trial involving 2,276 PAD patients with an indication for clopidogrel monotherapy. Patients with a separate indication for dual antiplatelet therapy or stronger antithrombotic therapy are not eligible for study participation. Patients randomized to the control group will receive clopidogrel 75mg once daily without pharmacogenetic guidance. Patients randomized to the intervention group will be tested for carriage of CYP2C19 *2 and *3 loss-of-function alleles, followed by a genotype-guided antithrombotic treatment with either clopidogrel 75mg once daily for normal metabolizers, clopidogrel 150mg once daily for intermediate metabolizers, or acetylsalicylic acid 80mg once daily plus rivaroxaban 2.5mg twice daily for poor metabolizers. The primary outcome is a composite of myocardial infarction, ischemic stroke, cardiovascular death, acute or chronic limb ischemia, peripheral vascular interventions, or death. The secondary outcomes are the individual elements of the primary composite outcome and clinically relevant bleeding complications.
Conclusion
The aim of the GENPAD study is to evaluate the efficacy, safety, and cost-effectiveness of a genotype-guided antithrombotic treatment strategy compared to conventional clopidogrel treatment in PAD patients.

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

Am Heart J: 18 Aug 2022; epub ahead of print
Kranendonk J, Willems LH, Vijver-Coppen RV, Coenen M, ... Kramers C, Warlé MC
Am Heart J: 18 Aug 2022; epub ahead of print | PMID: 35988587
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Abstract

Early Trends in Cardiac Allograft Vasculopathy After Implementation of the 2018 Donor Heart Allocation Policy in the United States: Short Title: CAV Trend After Allocation Policy Change.

Tehrani DM, Kim JS, Hsu JJ, Nsair A, ... Fearon WF, Parikh RV
Study objective
To evaluate the impact of the new donor heart allocation system implemented in the United States in October 2018 on development of early cardiac allograft vasculopathy (CAV).
Design
Retrospective cohort study.
Participants
Adult (≥ 18 years) heart transplant recipients registered in the United Network for Organ Sharing database between October 18, 2015 - October 17, 2018 (old system) and October 18, 2018 - May 31, 2020 (new system).
Main outcome measure
Incidence of angiographic CAV at 1 year (accelerated CAV) in the overall transplant population and among the highest acuity subgroup-Status 1A (old) and Status 1 or 2 (new). We included recipient and donor demographic, cardiovascular, and transplant factors in multivariable logistic regression models to identify predictors of accelerated CAV.
Results
Of 10,375 transplant recipients, 6,660 (64%) and 3,715 (36%) were listed in the old and new allocation cohorts, respectively. The incidence of accelerated CAV was 521 (8%) in the old period compared with 272 (7%) in the new period (p = 0.36). Similar incidence rates were observed in the highest acuity subgroup-363 (8%) compared with 143 (7%), respectively (p = 0.13). In adjusted analyses of the high-acuity cohort, the new allocation system was not associated with a higher likelihood of accelerated CAV (odds ratio = 0.87, 95% confidence interval: 0.70-1.08, p = 0.20).
Conclusions
The new donor heart allocation system is not associated with development of accelerated angiographic CAV at 1 year, including among recipients requiring the most urgent transplants.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 12 Aug 2022; epub ahead of print
Tehrani DM, Kim JS, Hsu JJ, Nsair A, ... Fearon WF, Parikh RV
Am Heart J: 12 Aug 2022; epub ahead of print | PMID: 35970399
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Abstract

Integrating Hemodynamics with Ventricular and Valvular Remodeling in Aortic Stenosis. A Paradigm Shift in Therapeutic Decision Making.

Pavlides GS, Chatzizisis YS, Porter TR
Aortic valve stenosis (AS) has traditionally been approached in hemodynamic terms. Although hemodynamics and symptoms have formed the basis of recommending interventional treatment in AS, other factors reflecting left ventricular and valvular/vascular remodeling are equally important for the prognosis and outcome of patients with AS. Left ventricular and valvular/vascular remodeling in AS do not consistently correlate with hemodynamic severity of AS. Those remodeling changes are reflected and can be detected by a variety of novel laboratory and imaging techniques, including biomarkers, echocardiography, cardiac magnetic resonance and gated Computer Tomography (CT) imaging. Taking all those elements into Heart Team therapeutic decision making in patients with AS, can significantly improve appropriate patient selection for interventional treatment and patient outcomes. We review this novel approach and propose a simple algorithm for decision making by the Heart Team, in patients with moderate or severe AS.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 12 Aug 2022; epub ahead of print
Pavlides GS, Chatzizisis YS, Porter TR
Am Heart J: 12 Aug 2022; epub ahead of print | PMID: 35970400
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Abstract

Black-White disparity in severe cardiovascular maternal morbidity: a systematic review and meta-analysis.

Ukah UV, Li X, Wei SQ, Healy-Profitós J, Dayan N, Auger N
Background
To synthesize existing evidence on Black-White disparities in the prevalence of severe cardiovascular maternal morbidity.
Methods
We searched MEDLINE, EMBASE, and CINAHL for observational studies published before July 31, 2021 that compared the risk of severe cardiovascular maternal morbidity between Black and White women. The outcome was severe cardiovascular maternal morbidity, including acute myocardial infarction, peripartum cardiomyopathy, and stroke during pregnancy, delivery, or postpartum. We extracted relevant information including adjusted and unadjusted effect estimates. We used random-effects models to estimate the pooled association between race and severe cardiovascular maternal morbidity, presented as odds ratios with 95% confidence intervals for the comparison of Black women relative to White women.
Results
We included 18 studies that met the eligibility criteria for systematic review and meta-analysis. All studies were conducted in the U.S. and included a total of 7,656,876 Black women and 26,412,600 White women. Compared with White women, Black women had an increased risk of any severe cardiovascular maternal morbidity (adjusted odds ratio, 1.90; 95% confidence interval, 1.54-2.33). Black women were at risk of acute myocardial infarction (adjusted odds ratio, 1.38; 95% confidence interval, 1.14-1.68), peripartum cardiomyopathy (adjusted odds ratio, 1.71; 95% confidence interval, 1.51-1.94), and stroke (adjusted odds ratio, 2.13; 95% confidence interval, 1.39-3.26).
Conclusion
Black women have a considerably higher risk of severe cardiovascular maternal morbidity than White women, including acute myocardial infarction, peripartum cardiomyopathy, and stroke. Reducing inequality in adverse cardiovascular outcomes of pregnancy between Black and White women should be prioritized.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 06 Aug 2022; epub ahead of print
Ukah UV, Li X, Wei SQ, Healy-Profitós J, Dayan N, Auger N
Am Heart J: 06 Aug 2022; epub ahead of print | PMID: 35944667
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Abstract

Pre-surgery optimization of patients\' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial.

Salzmann S, Laferton JAC, Shedden-Mora MC, Horn N, ... Moosdorf R, Rief W
The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients\' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center randomized, controlled, prospective trial (RCT), N=567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (à 50 min), two phone consultations (à 20 min) during the week prior to surgery, and one booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study\'s primary endpoint will be patients\' illness-related disability 6 months after surgery. Secondary outcomes will be patients\' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (e.g., inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 05 Aug 2022; epub ahead of print
Salzmann S, Laferton JAC, Shedden-Mora MC, Horn N, ... Moosdorf R, Rief W
Am Heart J: 05 Aug 2022; epub ahead of print | PMID: 35940247
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Abstract

Identifying Quality of Life Outcome Patterns to Inform Treatment Choices in Ischemic Cardiomyopathy.

Mori M, Mark DB, Khera R, Lin H, ... Spertus JA, Krumholz HM
Background
The Surgical Treatment for Ischemic Heart Failure (STICH) trial found that routine use of coronary artery bypass surgery (CABG) improved mean quality of life (QoL) scores relative to guideline-directed medical therapy (GDMT) in patients with ischemic cardiomyopathy. However, mean differences in QoL scores do not provide what patients want to know when facing a high-risk/high-benefit treatment choice.
Methods
We analyzed Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary scores in CABG and GDMT patients over 36 months using a combination of statistical methods to group QoL data into clinically relevant outcome patterns (phenotype trajectories) and to then identify the main baseline predictors of each phenotype. QoL outcome phenotypes were developed using mixture models to define the dominant phenotype trajectories present in STICH QoL data. Logistic regression models were used to predict each patient\'s probability of achieving each outcome pattern with each treatment.
Results
In STICH, 592 patients underwent CABG and 607 were managed with GDMT. Our analyses identified three phenotype trajectory patterns in both treatment groups. Two of the three trajectories showed improving patterns, and were classified as \"good QoL trajectories\", seen in 498 (84.1%) CABG and 449 (73.9%) GDMT patients. Defining a consequential CABG-GDMT treatment difference as a >10% higher absolute predicted probability of belonging to good QoL trajectories, 277 (23.5%) patients were more likely to have good outcome with CABG while 45 (3.8%) patients were more likely to have a good outcome with GDMT. For 644 (54.7%) patients, CABG and GDMT probabilities of a good outcome were within 5% of each other.
Conclusions
The pattern of QoL outcomes after CABG compared with GDMT in STICH followed three main phenotypic trajectories, which could be predicted based on individual baseline features. Patient-specific predictions about expected QoL outcomes with different treatment choices provide an intuitive framework for personalizing patient decision making.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 03 Aug 2022; epub ahead of print
Mori M, Mark DB, Khera R, Lin H, ... Spertus JA, Krumholz HM
Am Heart J: 03 Aug 2022; epub ahead of print | PMID: 35932911
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Abstract

Choice of Antihypertensive Agent in Isolated Systolic Hypertension and Isolated Diastolic Hypertension: A Secondary Analysis of the ALLHAT Trial.

Wang SY, Hanna JM, Gongal P, Onuma O, Nanna MG
Despite broad treatment recommendations, there are no published reports comparing efficacy of different antihypertensive agents in patients with isolated systolic hypertension or isolated diastolic hypertension. This study was a secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. We compared the use of chlorthalidone, amlodipine, or lisinopril on the primary outcome of combined coronary heart disease, stroke, or all-cause mortality in patients with isolated systolic hypertension or isolated diastolic hypertension.

Copyright © 2022 Elsevier Ltd. All rights reserved.

Am Heart J: 03 Aug 2022; epub ahead of print
Wang SY, Hanna JM, Gongal P, Onuma O, Nanna MG
Am Heart J: 03 Aug 2022; epub ahead of print | PMID: 35932912
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Impact:
Abstract

Glycemic status and the association of change in blood pressure with incident cardiovascular disease.

Suzuki Y, Kaneko H, Yano Y, Okada A, ... Yasunaga H, Komuro I
Background
The clinical benefit of blood pressure (BP) reduction in individuals with diabetes has not been fully elucidated. We sought to identify the clinical impact of BP reduction on incident cardiovascular disease in people having diabetes and hypertension.
Methods
We conducted a retrospective cohort study including 754,677 individuals (median age 47 years, 75.8 % men) with stage 1/stage 2 hypertension. Participants were categorized using fasting plasma glucose (FPG) at baseline as normal FPG (FPG < 100 mg/dL) (n=517,372), prediabetes (FPG:100-125 mg/dL) (n=197,836), or diabetes mellitus (FPG ≥126 mg/dL) (n=39,469). The primary outcome was heart failure (HF), and the secondary outcomes included ischemic heart disease (IHD) including myocardial infarction and angina pectoris, and stroke.
Results
Over a mean follow-up of 1111±909 days, 18,429 HFs, 17,058 IHDs, and 8,795 strokes were recorded. Reduction in BP of< 120/80 mmHg at one-year was associated with a lower risk of developing HF (HR:0.77, 95% CI:0.72-0.82), IHD (HR:0.84, 95% CI:0.79-0.89), and stroke (HR:0.75, 95% CI:0.69-0.82) in individuals with normal FPG, whereas it was not associated with a risk of developing HF (HR:0.98, 95% CI:0.81-1.17) and stroke (HR:0.82, 95% CI:0.62-1.09) in those with DM. Interaction analyses showed that the influence of BP reduction on incident HF was attenuated with people with prediabetes or DM. A multitude of sensitivity analyses confirmed our results.
Conclusions
The association of BP reduction with the risk of developing HF was attenuated with deteriorating glucose tolerance. The optimal management strategy for hypertensive people with prediabetes or DM for the prevention of developing cardiovascular disease (particularly HF) is needed to be established.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 21 Jul 2022; epub ahead of print
Suzuki Y, Kaneko H, Yano Y, Okada A, ... Yasunaga H, Komuro I
Am Heart J: 21 Jul 2022; epub ahead of print | PMID: 35872125
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Impact:
Abstract

Antiplatelet Regimens Following Carotid Artery Revascularization.

Lee M, Ahmed ZV, Huang J, Brice A, ... Smolderen KG, Mena-Hurtado C
Dual antiplatelet therapy (DAPT) is indicated following carotid artery stenting (CAS) and single antiplatelet therapy (SAPT) following carotid endarterectomy (CEA), but it remains unknown how providers adhere to these guidelines in real-world clinical practice. Using the Vascular Quality Initiative New England data, we found that of 12,257 patients, 82% patients were discharged on DAPT following CAS and 66% were discharged on SAPT following CEA. While a high percentage of patients undergoing CAS appropriately receive DAPT, the use of SAPT following CEA exists with more variability and lower adherence rates.

Copyright © 2022 Elsevier Ltd. All rights reserved.

Am Heart J: 18 Jul 2022; epub ahead of print
Lee M, Ahmed ZV, Huang J, Brice A, ... Smolderen KG, Mena-Hurtado C
Am Heart J: 18 Jul 2022; epub ahead of print | PMID: 35863439
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Impact:
Abstract

Six-lead device superior to single-lead smartwatch ECG in atrial fibrillation detection.

Scholten J, Jansen WPJ, Horsthuis T, Mahes AD, ... de Groot JR, Bokma JP
This was a head-to-head comparative study on different ECG-based smartwatches and devices for atrial fibrillation detection. We prospectively included 220 patients scheduled for electrical cardioversion and recorded ECGs with three different devices (Withings Move ECG, Apple Watch 5, Kardia Mobile six-leads) as well as the standard 12-lead ECG (gold standard), both before and after cardioversion. All atrial fibrillation detection algorithms had high accuracy (sensitivity and specificity: 91-99%) but were hampered by uninterpretable recordings (20%-24%). In cardiologists\' interpretation, the six-lead device was superior (sensitivity 99%, specificity 97%) to both single-lead smartwatches (p<0.05) for atrial fibrillation detection.

Copyright © 2022 Elsevier Inc. All rights reserved.

Am Heart J: 15 Jul 2022; epub ahead of print
Scholten J, Jansen WPJ, Horsthuis T, Mahes AD, ... de Groot JR, Bokma JP
Am Heart J: 15 Jul 2022; epub ahead of print | PMID: 35850242
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Abstract

Rationale and Design of a Pragmatic Trial Aimed at Improving Treatment of Hyperlipidemia in Outpatients with Very High Risk Atherosclerotic Cardiovascular Disease: A PRagmatic Trial Of Messaging to Providers about Treatment of HyperLIPIDemia (PROMPT-LIPID).

Shah N, Ghazi L, Yamamoto Y, Martin M, ... Wilson FP, Desai NR
Background
Despite guideline recommendations to optimize LDL cholesterol (LDL-C) reduction with intensification of lipid-lowering therapy (LLT) in patients with atherosclerotic cardiovascular disease (ASCVD), few of these patients achieve LDL-C < 70 mg/dL in practice.
Purpose
We developed a real-time, targeted electronic health record (EHR) alert with embedded ordering capability to promote intensification of evidence based LLT in outpatients with very high risk ASCVD.
Methods
We designed a pragmatic, multicenter, single-blind, cluster randomized trial to test the effectiveness of an EHR-based LLT intensification alert. The study will enroll about 100 providers who will be randomized to either receive the alert or undergo usual care for outpatients with high risk ASCVD with LDL-C > 70 mg/dL. Total enrollment will include 2500 patients. The primary outcome will be the proportion of patients with LLT intensification at 90 days. Secondary outcomes include achieved LDL-C at 6 months and the proportion of patients with LDL-C < 70 mg/dL or < 55 mg/dL at 6 months.
Results
Enrollment of 1250 patients (50% of goal) was reached within 47 days (50% women, mean age 72, median LDL-C 91). At baseline, 71%, 9%, and 3% were on statins, ezetimibe, or PCSK9i, respectively.
Conclusions
PROMPT-LIPID has rapidly reached 50% enrollment of patients with very high risk ASCVD, demonstrating low baseline LLT utilization. This pragmatic, EHR-based trial will determine the effectiveness of a real-time, targeted EHR alert with embedded ordering capability to promote LLT intensification. Findings from this low-cost, widely scalable intervention to improve LDL-C may have important public health implications.
Trial registration
clinicaltrials.gov NCT04394715.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 13 Jul 2022; epub ahead of print
Shah N, Ghazi L, Yamamoto Y, Martin M, ... Wilson FP, Desai NR
Am Heart J: 13 Jul 2022; epub ahead of print | PMID: 35841944
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Impact:
Abstract

Targeted potassium levels to decrease arrhythmia burden in high risk patients with cardiovascular diseases (POTCAST): Study protocol for a randomized controlled trial.

Winsløw U, Sakthivel T, Zheng C, Bosselmann H, ... Bundgaard H, Jøns C
Background
Low plasma potassium (p-K) is associated with increased risk of malignant arrhythmia and observational studies indicate protective effects of p-K in the upper reference level. However, randomized clinical studies are needed to document whether actively increasing p-K to high-normal levels is possible and safe and improves cardiovascular outcomes.
Objective
To investigate if increased p-K reduces the risk of malignant arrhythmia and all-cause death in high-risk patients with a cardiovascular disease treated with an implantable cardioverter defibrillator (ICD) for primary or secondary preventive causes. Secondly, to investigate whether high-normal p-K levels can be safely reached and maintained using already available medications and potassium-rich dietary guidance.
Methods
This is a prospective, randomized, and open-labelled study enrolling patient at high-risk of malignant arrhythmias. According to sample size calculations, 1,000 patients will be randomized 1:1 to either an investigational regiment that aims to increase and maintain p-K at high-normal levels (4.5-5.0 mmol/l) or to usual standard of care and followed for an expected four years. The trial will run until a total of 291 events have occurred providing an α=0.05 and 1-β=0.80. The composite primary endpoint includes ventricular tachycardia >125 bpm lasting >30 seconds, any appropriate ICD-therapy, and all-cause mortality. At present, 739 patients have been randomized.
Conclusions
We present the rationale for the design of the POTCAST trial. The inclusion was initiated 2019 and is expected to be finished 2022. The study will show if easily available treatments to increase p-K may be a new treatment modality to protect against malignant arrythmias.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 11 Jul 2022; epub ahead of print
Winsløw U, Sakthivel T, Zheng C, Bosselmann H, ... Bundgaard H, Jøns C
Am Heart J: 11 Jul 2022; epub ahead of print | PMID: 35835265
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Impact:
Abstract

Inflammation biomarkers and incident coronary heart disease: The Reasons for Geographic and Racial Differences in Stroke Study.

Akinyelure OP, Colantonio LD, Chaudhary NS, Jaeger BC, ... Safford MM, Irvin MR
Background
Individual inflammation biomarkers are associated with incident coronary heart disease (CHD) events. However, there is limited research on whether the risk for incident CHD is progressively higher with a higher number of inflammation biomarkers in abnormal levels.
Methods
We used data from 15,758 REasons for Geographic and Racial Differences in Stroke (REGARDS) study participants aged ≥45 years without a history of CHD at baseline in 2003-2007. Abnormal levels of baseline high-sensitivity C-reactive protein, leukocyte count and serum albumin were defined as ≥3.8 mg/L (3rd tertile), ≥6.3 x 109 cells/L (3rd tertile), and <4.0 g/dL (1st tertile), respectively. The outcome was a composite of incident myocardial infarction or CHD death.
Results
Overall, 38.9% (n=6,123) had 0, 36.6% (n=5,774) had 1, 19.8% (n=3,113) had 2 and 4.7% (n=748) had 3 biomarkers of inflammation in abnormal levels. Over a median follow-up of 11.4 years, 954 (6.1%) participants had incident CHD. The rate of incident CHD per 1000 person-years for individuals with 0, 1, 2, and 3 biomarkers of inflammation in abnormal levels was 4.4 (95% confidence interval [CI]: 3.9-5.0), 6.3 (95% CI: 5.6-6.9), 8.8 (95% CI: 7.8-9.9), and 10.6 (95% CI: 8.1-13.1), respectively. Multi-variable adjusted hazard ratios for incident CHD associated with 1, 2 and 3 versus no inflammation biomarker in abnormal levels were 1.26 (95% CI: 1.07-1.49), 1.72 (95% CI: 1.43-2.07), and 1.84 (95% CI: 1.37-2.47), respectively (P-trend < 0.001).
Conclusions
The number of inflammation markers in abnormal levels was associated with increased risk of incident CHD after multi-variable adjustment.

Copyright © 2022. Published by Elsevier Inc.

Am Heart J: 07 Jul 2022; epub ahead of print
Akinyelure OP, Colantonio LD, Chaudhary NS, Jaeger BC, ... Safford MM, Irvin MR
Am Heart J: 07 Jul 2022; epub ahead of print | PMID: 35810789
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Impact:

This program is still in alpha version.