Journal: Am Heart J

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<div><h4>A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT).</h4><i>Golian M, Sadek MM, Aydin A, Davis D, ... Wells GA, Birnie DH</i><br /><b>Background</b><br />Arm restriction after cardiac implantable electronic device (CIED) placement is common practice despite minimal supporting evidence. Patients receive a range of restriction recommendations of variable durations with the goal of reducing complications such as wound dehiscence, infection, lead dislodgement, or hematoma formation. These movement limitations can lead to emotional stress and anxiety, complications such as frozen shoulder, and upper extremity venous thrombosis due to immobilization. There are no published clinical trials assessing the benefits and risks of arm restrictions post-CIED implant.<br /><b>Objectives</b><br />The randomized trial of lenient versus strict arm and activity instruction post-CIED surgery (LENIENT trial; NCT04915261) is a single center non-blinded randomized prospective study designed to evaluate lenient compared to restrictive post-CIED care instructions. We hypothesize that there will be no significant difference in complications between the arms.<br /><b>Methods/design</b><br />All patients receiving a de novo CIED or those with upgrades and revisions requiring a new lead implant will be enrolled. Subjects are enrolled in a non-blinded randomized prospective trial with 6 randomly assigned 8-month periods, during which either a lenient or restrictive post-operative activity instructions will be given to all patients. Post-operative instructions are given at the time of discharge and further reinforced by recurrent interactive voice recognition (IVR) phone calls, text messages and emails. The requirement for individual consent has been waived. The primary endpoint is a composite of (1) lead dislodgement, (2) frozen shoulder, (3) upper extremity venous thrombosis, (4) clinically significant hematoma, and (5) infection occurring within 52 weeks of index surgery. The study is a non-inferiority trial with a sample size of 1250 per group.<br /><b>Discussion</b><br />This is the first large randomized clinical trial designed to establish an evidence-based post-operative standard of care for patients undergoing CIED implantation. This will improve the quality of care provided to patients and help guide implanting physicians providing post-operative care instructions.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 25 Jan 2023; epub ahead of print</small></div>
Golian M, Sadek MM, Aydin A, Davis D, ... Wells GA, Birnie DH
Am Heart J: 25 Jan 2023; epub ahead of print | PMID: 36708911
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<div><h4>A U-shaped association between dietary phosphorus intake and new-onset hypertension: A nationwide cohort study in China.</h4><i>Wu Q, Ye Z, Zhou C, Liu M, ... Liu C, Qin X</i><br /><b>Background</b><br />The association between dietary phosphorus intake and the risk of hypertension remains uncertain. We aimed to investigate the relation of dietary phosphorus intake with new-onset hypertension among Chinese adults.<br /><b>Methods</b><br />A total of 12,177 participants who were free of hypertension at baseline from the China Health and Nutrition Survey (CHNS) were included. Dietary intake was measured by 3 consecutive 24-hour dietary recalls combined with a household food inventory. New-onset hypertension was defined as systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg or diagnosed by a physician or under antihypertensive treatment during the follow-up.<br /><b>Results</b><br />During a median follow-up of 6.1 years, 4,269 participants developed new-onset hypertension. Overall, the association between dietary phosphorus intake and new-onset hypertension followed a U-shape (P for nonlinearity<0.001). Consistently, when dietary phosphorus intake was assessed as quintiles, compared with those in the 3rd-4th quintiles (912.0-<1089.5 mg/d), a significantly higher risk of new-onset hypertension was found in participants in the 1st-2nd quintiles (<912.0mg/d: HR, 1.23; 95% CI, 1.14-1.33), and the 5th quintile (≥1089.5mg/d: HR, 1.21; 95% CI, 1.10-1.33).<br /><b>Conclusions</b><br />There was a U-shaped association between dietary phosphorus intake and new-onset hypertension in general Chinese adults.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 20 Jan 2023; epub ahead of print</small></div>
Wu Q, Ye Z, Zhou C, Liu M, ... Liu C, Qin X
Am Heart J: 20 Jan 2023; epub ahead of print | PMID: 36690241
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<div><h4>βeta Blocker Interruption after Uncomplicated Myocardial Infarction: Rationale and Design of the randomized ABYSS trial.</h4><i>Silvain J, Cayla G, Ferrari E, Range G, ... Montalescot G, ABYSS investigators of the ACTION Study Group</i><br /><b>Background</b><br />The long-term use of β-blocker after myocardial infarction (MI) when global left ventricular ejection fraction (LVEF) is preserved has not been studied in the era of modern myocardial reperfusion and secondary prevention therapies. It is unknown whether β-blockers are useful in stable post-MI patients without reduced LVEF and without heart failure.<br /><b>Methods</b><br />The Assessment of β-blocker interruption one Year after an uncomplicated myocardial infarction on Safety and Symptomatic cardiac events requiring hospitalization (ABYSS) Trial enrolled in 49 centers in France, 3700 patients with a prior (> 6 months) history of MI and a LVEF >40%, chronically treated with a β-blocker and without any major cardiovascular event (MACE) in the past 6 months. These patients were randomized to interruption or continuation of their β-blocker therapy. The primary objective is to demonstrate the non-inferiority of interruption versus continuation of the β-blocker therapy on the primary composite endpoint of all-cause death, stroke, MI, hospitalization for any cardiovascular reason at the end of follow-up (accrual follow-up) with a one-year minimum follow-up for the last randomized patient. Secondary objectives will focus on patient reported outcomes with the evaluation of the quality of life before and after randomization with the EQ5D-5L questionnaire. Enrolment has been completed.<br /><b>Conclusion</b><br />The ABYSS trial evaluates the cardiovascular safety of β-blocker interruption in stabilized post-MI patients without heart failure nor reduced LVEF. ABYSS trial is a reappraisal of β-blockers life-long therapy in stable post-MI patients without reduced LVEF.<br /><b>Clinical trial registration</b><br />NCT03498066 (clinicaltrials.gov).<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 19 Jan 2023; epub ahead of print</small></div>
Silvain J, Cayla G, Ferrari E, Range G, ... Montalescot G, ABYSS investigators of the ACTION Study Group
Am Heart J: 19 Jan 2023; epub ahead of print | PMID: 36682596
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<div><h4>Long-Term Incidence of Infective Endocarditis among Patients with Congenital Heart Disease.</h4><i>Havers-Borgersen E, Butt JH, Østergaard L, Petersen JK, ... Køber L, Fosbøl EL</i><br /><b>Background</b><br />Patients with congenital heart disease (CHD) are at lifelong high risk of infective endocarditis (IE). The risk of IE presumably differs among different CHD, but little knowledge exists on the area.<br /><b>Methods</b><br />In this observational cohort study, all CHD-patients born in 1977-2018 were identified using Danish nationwide registries and followed from date of birth until first-time IE, emigration, death, or end of study (December 31, 2018). The comparative risk of IE among CHD-patients versus age- and sex-matched controls from the background population was assessed. The risk of IE was stratified according to type of CHD and factors associated with IE including sex and relevant time-varying coefficients (i.e., cyanosis, cardiac prostheses, diabetes mellitus, chronic kidney disease, and cardiac implantable electronic devices) were examined using Cox-regression analysis.<br /><b>Results</b><br />A total of 23,464 CHD-patients (50.0% men) were identified and matched with 93,856 controls. During a median follow-up of 17.7 years, 217(0.9%) CHD-patients and 4(0.0%) controls developed IE, corresponding to incidence rates of 5.2(95%CI 4.6-6.0) and 0.02(95%CI 0.01-0.1) per 10,000 person-years, respectively. The incidence of IE was greatest among patients with tetralogy of Fallot, malformations of the heart chambers (including transposition of the great arteries, univentricular heart, and truncus arteriosus), atrioventricular septal defects, and heart valve defects. Factors associated with IE among CHD-patients included male sex, cyanosis, cardiac prostheses, chronic kidney disease, and cardiac implantable electronic devices.<br /><b>Conclusions</b><br />CHD-patients have a substantially higher associated incidence of IE than the background population. With an increasing longevity of these patients, relevant guidelines concerning preventive measures are important.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 18 Jan 2023; epub ahead of print</small></div>
Havers-Borgersen E, Butt JH, Østergaard L, Petersen JK, ... Køber L, Fosbøl EL
Am Heart J: 18 Jan 2023; epub ahead of print | PMID: 36681172
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<div><h4>Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial.</h4><i>Malm CJ, Alfredsson J, Erlinge D, Gudbjartsson T, ... Tønnessen T, Jeppsson A</i><br /><AbstractText>The TACSI trial (ClinicalTrials.gov Identifier: NCT03560310) tests the hypothesis that one-year treatment with dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and ticagrelor is superior to only ASA after isolated coronary artery bypass grafting (CABG) in patients with acute coronary syndrome. The TACSI trial is an investor-initiated pragmatic, prospective, multinational, multicenter, open-label, registry-based randomized trial with 1:1 randomization to DAPT with ASA and ticagrelor or ASA only, in patients undergoing first isolated CABG, with a planned enrollment of 2200 patients at Nordic cardiac surgery centers. The primary efficacy endpoint is a composite of time to all cause death, myocardial infarction, stroke, or new coronary revascularization within 12 months after randomization. The primary safety endpoint is time to hospitalization due to major bleeding. Secondary efficacy endpoints include time to the individual components of the primary endpoint, cardiovascular death and rehospitalization due to cardiovascular causes. High-quality health-care registries are used to assess primary and secondary endpoints. The patients will be followed for 10 years. The TACSI trial will give important information useful for guiding the antiplatelet strategy in acute coronary syndrome patients treated with CABG.</AbstractText><br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 18 Jan 2023; epub ahead of print</small></div>
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<div><h4>Multi-Marker Risk Assessment in Patients Hospitalized with COVID-19: Results from the American Heart Association COVID-19 Cardiovascular Disease Registry.</h4><i>Bhatt AS, Daniels LB, de Lemos J, Goodrich E, Bohula EA, Morrow DA</i><br /><b>Background</b><br />The pathobiology of inflammation, thrombosis, and myocardial injury associated with SARS-CoV2 may be assessed by circulating biomarkers. However, their relative prognostic importance has been incompletely described.<br /><b>Methods</b><br />We analyzed data from patients hospitalized with COVID-19 from 1/2020 to 4/2021 at 122 US hospitals in the AHA COVID-19 Cardiovascular (CV) Disease Registry. Patients with data for D-dimer, C-reactive protein (CRP), ferritin, natriuretic peptides [NP], or cardiac troponin (cTn) at admission were included. cTn quintiles were indexed to the assay-specific 99<sup>th</sup>%ile reference limits. Using multivariable logistic regression, we assessed the association between each biomarker by quintile [Q] and odds of in-hospital death and a cardiovascular and thrombotic composite.<br /><b>Results</b><br />Of 32,636 registry patients, 26,424 (81%) had admission values for ≥1 of the key biomarkers, of which 4527 (17%) had admission values for all five biomarkers. Each biomarker revealed a significant gradient for in-hospital mortality from Q1-Q5: D-dimer 14%-35%, CRP 11%-32%, ferritin 11%-30%, cTn 13%-43%, and NPs 7%-35% (p<sub>trend</sub> for each <0.001). After adjustment for other biomarkers and clinical variables, Q5 for NPs (OR:4.67, 95% CI: 3.05-7.14) retained the greatest relative odds for death; cTn (OR:2.68, 95% CI: 2.00-3.59) and NPs (OR:7.14, 95% CI: 4.92-10.37) were associated with the greatest odds of the CV composite. Q5 for D-dimer were associated with the highest risk of thrombotic events (OR: 9.02, 95% CI: 5.36-15.18).<br /><b>Conclusions</b><br />Among patients hospitalized with COVID-19, cTn and NPs identified patients at high risk for an in-hospital adverse cardiovascular outcome, while elevations in D-dimer identified patients at risk for thrombotic complications.<br /><br />Copyright © 2023 Elsevier Ltd. All rights reserved.<br /><br /><small>Am Heart J: 17 Jan 2023; epub ahead of print</small></div>
Bhatt AS, Daniels LB, de Lemos J, Goodrich E, Bohula EA, Morrow DA
Am Heart J: 17 Jan 2023; epub ahead of print | PMID: 36669711
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<div><h4>Total Events and Net Clinical Benefit of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: The COMPASS Trial.</h4><i>Branch KRH, Probstfield JL, Bosch J, Bhatt DL, ... Yusuf S, Eikelboom JW</i><br /><b>Background</b><br />Low dose rivaroxaban with aspirin reduced major cardiovascular events (MACE) compared to aspirin alone in patients with cardiovascular disease although effects on total events are unknown.<br /><b>Methods</b><br />The COMPASS clinical trial randomized 27,395 participants with chronic coronary and/or peripheral artery disease to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg daily. We analyzed total (first and recurrent) MACE outcomes of cardiovascular death, stroke, or myocardial infarction, and the primary safety outcome of major bleeding. Exploratory analyses included on-treatment and net clinical benefit. Total MACE and safety events were modeled for each treatment.<br /><b>Results</b><br />MACE events were lowest in rivaroxaban with aspirin (379 first MACE, 432 total MACE) compared with rivaroxaban (448 first, 508 total) or aspirin alone (496 first, 574 total). Rivaroxaban and aspirin reduced total MACE events compared with aspirin alone [HR 0.75, 95% CI 0.66-0.85, p<0.0001, number needed to treat for 2 years (NNT<sub>2y</sub>) of 63]. Total major bleeding was higher for rivaroxaban with aspirin compared to aspirin, but severe bleeding was not increased. The net clinical benefit of rivaroxaban plus aspirin was 20% higher compared with aspirin alone [HR 0.80 (95% CI 16.3-31.6%)]. Rivaroxaban alone had no benefit on MACE outcomes compared with aspirin alone. MACE outcomes were similar for those on and off randomized treatment.<br /><b>Conclusions</b><br />Low dose rivaroxaban with aspirin significantly reduces first and total cardiovascular events compared with aspirin alone with a NNT<sub>2y</sub> of 63 and a 20% net clinical benefit.<br /><b>Clinical trial registration</b><br />NCT01776424. https://clinicaltrials.gov/ct2/show/NCT01776424.<br /><br />Copyright © 2023 Elsevier Ltd. All rights reserved.<br /><br /><small>Am Heart J: 13 Jan 2023; epub ahead of print</small></div>
Branch KRH, Probstfield JL, Bosch J, Bhatt DL, ... Yusuf S, Eikelboom JW
Am Heart J: 13 Jan 2023; epub ahead of print | PMID: 36646196
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<div><h4>Trends in Outcomes and Resource Utilization for Acute Myocardial Infarction Admissions During the COVID-19 Pandemic.</h4><i>Chouairi F, Pinsker B, Fudim M, Miller PE</i><br /><AbstractText>During the early COVID-19 pandemic, resources were at times rationed, and as a result, cardiovascular outcomes may have suffered, however despite this, there is a paucity of national data specifically examining the relationship between COVID-19 and acute myocardial infarction (AMI). Some of the most robust previous cohort studies suggest the risk of AMI is increased in patients with COVID-19 infection, and disproportionately so in certain patient populations. To better define national trends in the associations between COVID-19 and AMI, this study aimed to examine demographics, outcomes, and healthcare utilization in hospitalizations for AMI with a co-diagnosis of COVID-19 using a nationally representative database.</AbstractText><br /><br />Published by Elsevier Inc.<br /><br /><small>Am Heart J: 13 Jan 2023; epub ahead of print</small></div>
Chouairi F, Pinsker B, Fudim M, Miller PE
Am Heart J: 13 Jan 2023; epub ahead of print | PMID: 36646197
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<div><h4>Evaluation of the Association Between Circulating IL-1β and Other Inflammatory Cytokines and Incident Atrial Fibrillation in a Cohort of Postmenopausal Women.</h4><i>Gomez SE, Parizo J, Ermakov S, Larson J, ... Stefanick M, Perez MV</i><br /><b>Background</b><br />Inflammatory cytokines play a role in atrial fibrillation (AF). Interleukin (IL)-1β, which is targeted in the treatment of ischemic heart disease, has not been well-studied in relation to AF.<br /><b>Methods</b><br />Postmenopausal women from the Women\'s Health Initiative were included. Cox proportional hazards regression models were used to evaluate the association between log-transformed baseline cytokine levels and future AF incidence. Models were adjusted for body mass index, age, race, education, hypertension, diabetes, hyperlipidemia, current smoking, and history of coronary heart disease, congestive heart failure, or peripheral artery disease.<br /><b>Results</b><br />Of 16,729 women, 3,943 developed AF over an average of 8.5 years. Racial and ethnic groups included White (77.4%), Black/African-American (16.1%), Asian (2.7%), American Indian/Alaska Native (1.0%), and Hispanic (5.5%). Baseline IL-1β log continuous levels were not significantly associated with incident AF (HR 0.86 per 1 log (pg/mL) increase, p=0.24), similar to those of other inflammatory cytokines, IL-7, IL-8, IL-10, IGF-1, and TNF-α. There were significant associations between C-reactive protein (CRP) and IL-6 with incident AF.<br /><b>Conclusions</b><br />In this large cohort of postmenopausal women, there was no significant association between IL-1β and incident AF, although downstream effectors, CRP and IL-6, were associated with incident AF.<br /><br />Copyright © 2023 Elsevier Ltd. All rights reserved.<br /><br /><small>Am Heart J: 13 Jan 2023; epub ahead of print</small></div>
Gomez SE, Parizo J, Ermakov S, Larson J, ... Stefanick M, Perez MV
Am Heart J: 13 Jan 2023; epub ahead of print | PMID: 36646198
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<div><h4>Characteristics and outcomes of patients with no standard modifiable risk factors undergoing primary revascularization for acute myocardial infarction: Insights from the nationwide J-PCI registry.</h4><i>Saito Y, Inohara T, Kohsaka S, Wada H, ... Kozuma K, J-PCI Registry Investigators</i><br /><b>Background</b><br />Identification of and therapeutic approaches to standard modifiable risk factors (SMuRFs), including hypertension, diabetes, dyslipidemia, and smoking, have led to improved survival of patients at risk for coronary events. However, recent studies have indicated that a significant proportion of patients with acute myocardial infarction (AMI) have no SMuRFs. We aimed to assess in-hospital outcomes and the prevalence of these patients using the Japanese nationwide percutaneous coronary intervention (J-PCI) registry.<br /><b>Methods</b><br />The J-PCI is a procedure-based registration program in Japan. A total of 115,437 PCI procedures were performed on patients with AMI between January 2019 and December 2020. The participants were divided into two groups: those with at least one SMuRF and those without any SMuRFs. The primary outcome was in-hospital mortality.<br /><b>Results</b><br />Of the 115,437 patients with AMI, 1,777 (1.6%) had no SMuRFs. Patients without SMuRFs were older; more likely to have left main disease; and more likely to present with heart failure, cardiogenic shock, and cardiac arrest than those with SMuRFs, resulting in higher rates of mechanical circulatory support use and impaired post-PCI coronary blood flow. In-hospital mortality was significantly higher in patients without SMuRFs than in those with SMuRFs (18.3% vs. 5.3%, p<0.001), irrespective of the presence or absence of ST-segment elevation.<br /><b>Conclusions</b><br />In Japan, where annual health checks are mandated under universal healthcare coverage, the vast majority of patients with AMI undergoing PCI have SMuRFs. However, although small in number, patients without SMuRFs are more likely to present with life-threatening conditions and have worse in-hospital survival.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 12 Jan 2023; epub ahead of print</small></div>
Saito Y, Inohara T, Kohsaka S, Wada H, ... Kozuma K, J-PCI Registry Investigators
Am Heart J: 12 Jan 2023; epub ahead of print | PMID: 36642224
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<div><h4>Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial.</h4><i>Spaulding C, Krackhardt F, Bogaerts K, Urban P, ... Morice MC, Eccleshall S</i><br /><b>Background</b><br />Drug eluting stents (DES) are associated with a 2% to 4% annual rate of target lesion failure through 5-to-10-year follow-up. The presence of a metallic protheses is a trigger for neo-atherosclerosis and very late stent thrombosis. A \"leave nothing behind\" strategy using Drug Coated Balloons has been suggested; however, paclitaxel coated balloons are only recommended in selected indications. Recently a novel sirolimus eluting balloon, the SELUTION SLR <sup>TM</sup> 014 PTCA balloon (SEB) (M.A. MedAlliance SA, Nyon, Switzerland) has been developed.<br /><b>Hypothesis</b><br />A strategy of percutaneous coronary intervention (PCI) with SEB and provisional DES is non-inferior to a strategy of systematic DES on target vessel failure (TVF) at one and five years. If non-inferiority is met at 5 years, superiority will be tested.<br /><b>Design</b><br />SELUTION DeNovo is a multi-center international open-label randomized trial. Subjects meeting eligibility criteria are randomized 1:1 to treatment of all lesions with either SEB and provisional DES or systematic DES. Major inclusion criteria are PCI indicated for ≥1 lesion considered suitable for treatment by either SEB or DES and clinical presentation with chronic coronary syndrome, unstable angina or non-ST segment elevation (NSTEMI). There is no limitation in the number of lesions to be treated. Target lesions diameters are between 2 and 5 mm. Major exclusion criteria are lesions in the left main artery, chronic total occlusions, ST segment elevation myocardial infarction and unstable NSTEMI. 3326 patients will be included in 50 sites in Europe and Asia. TVF rates and their components will be determined at 30 days, 6 months and annually up to 5 years post-intervention. Among secondary endpoints, bleeding events, cost-effectiveness data and net clinical benefits will be assessed.<br /><b>Summary</b><br />SELUTION DeNovo trial is an open-label, multi-center international randomized trial comparing a strategy of PCI with SEB and provisional DES to a strategy of PCI with systematic DES on TVF at one and five years. Non-inferiority will be tested at one and five years. If non-inferiority is met at five years, superiority will be tested.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 12 Jan 2023; epub ahead of print</small></div>
Spaulding C, Krackhardt F, Bogaerts K, Urban P, ... Morice MC, Eccleshall S
Am Heart J: 12 Jan 2023; epub ahead of print | PMID: 36642225
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<div><h4>Does Early Detection of Atrial Fibrillation Reduce the Risk of Thromboembolic Events? Rationale and Design of the Heartline Study.</h4><i>Gibson CM, Steinhubl S, Lakkireddy D, Turakhia MP, ... Spertus JA, Heartline Steering Committee</i><br /><b>Background</b><br />The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown.<br /><b>Methods</b><br />Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch Irregular Rhythm Notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were \"watch-naïve\" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary endpoint is time from randomization to clinical diagnosis of AF, with confirmation by healthcare claims. Key secondary endpoints are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, direct oral anticoagulant medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study.<br /><b>Conclusion</b><br />The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment.<br /><b>Trial registration</b><br />ClinicalTrials.gov Identifier: NCT04276441.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 12 Jan 2023; epub ahead of print</small></div>
Gibson CM, Steinhubl S, Lakkireddy D, Turakhia MP, ... Spertus JA, Heartline Steering Committee
Am Heart J: 12 Jan 2023; epub ahead of print | PMID: 36642226
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<div><h4>Outcomes in Patients with Cardiometabolic Disease Who Develop Hyperkalemia While Treated with a RAAS Inhibitor.</h4><i>Johnson M, Morrison FJ, McMahon G, Su M, Turchin A</i><br /><b>Background</b><br />Many patients with indications for renin-angiotensin-aldosterone system inhibitor (RAASi) therapy are not receiving these medications. Concern about hyperkalemia is thought to contribute to this lack of evidence-based therapy.<br /><b>Methods</b><br />A retrospective cohort study included adult patients in primary care practices affiliated with an integrated healthcare delivery system treated with RAASi between 2000-2019 for any of the following indications: a) coronary artery disease (CAD); b) heart failure (HF) with a left ventricle ejection fraction ≤ 40%; c) diabetes mellitus (DM) with proteinuria; or d) chronic kidney disease (CKD) with proteinuria. Relationship between hyperkalemia (K > 5.0 mEg/L) over the first 12 months of follow-up and a composite endpoint of cardiovascular events, renal dysfunction and all-cause mortality was evaluated.<br /><b>Results</b><br />Among 82,732 study patients, 7,727 (9.34%) developed hyperkalemia. Patients with hyperkalemia were older (69.0 vs. 64.6) and more likely to have CAD (57.8 vs. 53.7%), CKD (57.3 vs. 51.1%), HF (19.3 vs. 9.7%) and DM (45.3 vs. 33.3%) (P < 0.001 for all). Five-year cumulative risk of the primary outcome was higher in patients who did (63.9%; 95% CI 62.8-65.1%) versus did not (37.2%; 95% CI 36.8-37.6%) develop hyperkalemia. Five-year cumulative risk of ED visit or hospitalization for hyperkalemia was 15.6% (14.7-16.6%) for patients with vs. 2.7% (95% CI 2.6-2.9) for patients without hyperkalemia, rising to 25.9% (95% CI 22.4-29.9) for patients with severe (K > 6.0 mEq/dL) hyperkalemia. Patients who experienced hyperkalemia were more likely (34.4%) than patients who did not (29.2%) to de-intensify RAASi therapy (P<.001). Five-year cumulative risk of the primary outcome was higher in patients who lowered RAASi dose (50.4%; 95% CI: 48.5-52.4%) or stopped RAASi therapy completely (49.3%; 95% CI: 48.5-50.1%), compared to patients who continued RAASi therapy (36.1%; 95% CI: 25.7-36.5). Similar findings were observed in multivariable analyses and for individual components of the primary outcome.<br /><b>Conclusions</b><br />Hyperkalemia is a common complication of RAASi therapy and is associated with an increased risk of multiple adverse outcomes. Patients who have their RAASi medications de-intensified after a hyperkalemic event have higher incidence of cardiovascular events, renal dysfunction and death.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 12 Jan 2023; epub ahead of print</small></div>
Johnson M, Morrison FJ, McMahon G, Su M, Turchin A
Am Heart J: 12 Jan 2023; epub ahead of print | PMID: 36642227
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<div><h4>Mortality and Rehospitalization after Mitral Valve Surgery as a Function of Age and Key Comorbidities.</h4><i>Havers-Borgersen E, Butt JH, Strange J, Carranza CL, Køber L, Fosbøl EL</i><br /><b>Background</b><br />Mitral valve surgery is associated with substantial perioperative risk and long-term complications. Data on long-term outcomes following surgery remain scarce and are hypothetically modified by age and comorbidities.<br /><b>Methods</b><br />This Danish nationwide study included patients ≥60 years of age undergoing mitral valve surgery from 2000-2018. Patients were followed from day of surgery until outcome of interest (i.e., rehospitalization or death) or maximum one year of follow-up. The absolute risks of outcomes were assessed, and associated factors were evaluated. Based on age and comorbidities, patients were stratified in four groups: low (<75 years+0 comorbidities), low intermediate (≥75 years/1 comorbidity), high intermediate (≥75 years+1 comorbidity/2 comorbidities), and high risk of death (≥75 years+≥2 comorbidities).<br /><b>Results</b><br />In total, 4,202 patients (62.9% men) were identified. Within 1 year after surgery, 504 (12.0%) died and 2,456 (58.5%) were rehospitalized. Factors associated with death included older age (>75 years), chronic obstructive lung disease, heart failure, prior myocardial infarction, prior stroke, liver disease, and kidney disease. The 1-year risks of death among patients in low, low-intermediate, high-intermediate, and high risk of death were 3.6%, 10.3%, 19.6%, and 27.7%, respectively. Diabetes mellitus and chronic obstructive lung disease were associated with an increased incidence of rehospitalization, and the incidence of rehospitalization was similar among the four abovementioned groups (57.8-62.8%).<br /><b>Conclusions</b><br />Mortality and rehospitalization risks after mitral valve surgery varied substantially with age and comorbidities. High-risk patients with >25% 1-year mortality may be easily identified using readily available clinical features.<br /><br />Copyright © 2023. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 12 Jan 2023; epub ahead of print</small></div>
Havers-Borgersen E, Butt JH, Strange J, Carranza CL, Køber L, Fosbøl EL
Am Heart J: 12 Jan 2023; epub ahead of print | PMID: 36642228
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<div><h4>Design and Pilot Implementation for the BETTER CARE-HF Trial: A Pragmatic Cluster-Randomized Controlled Trial Comparing Two Targeted Approaches to Ambulatory Clinical Decision Support for Cardiologists.</h4><i>Mukhopadhyay A, Reynolds HR, Xia Y, Phillips LM, ... Katz SD, Blecker S</i><br /><AbstractText>Heart failure with reduced ejection fraction (HFrEF) is a leading cause of morbidity and mortality. However, shortfalls in prescribing of proven therapies, particularly mineralocorticoid receptor antagonist (MRA) therapy, account for several thousand preventable deaths per year nationwide. Electronic clinical decision support (CDS) is a potential low-cost and scalable solution to improve prescribing of therapies. However, the optimal timing and format of CDS tools is unknown. We developed two targeted CDS tools to inform cardiologists of gaps in MRA therapy for patients with HFrEF and without contraindication to MRA therapy: 1) an alert that notifies cardiologists at the time of patient visit, and 2) an automated electronic message that allows for review between visits. We designed these tools using an established CDS framework and findings from semi-structured interviews with cardiologists. We then pilot tested both CDS tools (n=596 patients) and further enhanced them based on additional semi-structured interviews (n=11 cardiologists). The message was modified to reduce the number of patients listed, include future visits, and list date of next visit. The alert was modified to improve noticeability, reduce extraneous information on guidelines, and include key information on contraindications. The BETTER CARE-HF (Building Electronic Tools to Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) trial aims to compare the effectiveness of the alert vs. the automated message vs. usual care on the primary outcome of MRA prescribing. To our knowledge, no study has directly compared the efficacy of these two different types of electronic CDS interventions. If effective, our findings can be rapidly disseminated to improve morbidity and mortality for patients with HFrEF, and can also inform the development of future CDS interventions for other disease states. (Trial registration: Clinicaltrials.gov NCT05275920).</AbstractText><br /><br />Copyright © 2023 Elsevier Ltd. All rights reserved.<br /><br /><small>Am Heart J: 11 Jan 2023; epub ahead of print</small></div>
Mukhopadhyay A, Reynolds HR, Xia Y, Phillips LM, ... Katz SD, Blecker S
Am Heart J: 11 Jan 2023; epub ahead of print | PMID: 36640860
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<div><h4>Public Reporting of Black Participation in Anti-Hypertensive Drug Clinical Trials.</h4><i>Green MD, Dalmage MR, Lusk JB, Kadhim EF, Skalla LA, O\'Brien EC</i><br /><b>Background</b><br />Non-Hispanic Black people in the United States have the highest prevalence of essential hypertension. Unfortunately, clinical trials often underrepresent Black patients. We aim to understand whether trial sponsorship type is associated with representation of Black participants in anti-hypertensive drug clinical trials. Then, we contextualize our findings amongst current efforts to improve diversity in clinical research populations.<br /><b>Methods</b><br />We searched ClinicalTrials.gov in May 2022 for antihypertensive drug trials. Of n=408 trials in our initial search, n=97 (23.77%) met inclusion criteria and were stratified by sponsorship type (industry versus non-industry). Standardized tests of difference were employed to compare characteristics of these trials, and linear regression was used to model change over time.<br /><b>Results</b><br />Of 97 trials reporting results from 2010-2020, there were minimal differences in the percent of Black patients enrolled in anti-hypertensive clinical trials by sponsorship type. Both industry and non-industry sponsored studies had high rates of non-reporting, with slightly more non-reporting for industry (73.2%) versus non-industry (66.67%) studies. Industry funded studies reported results to ClinicalTrials.gov within 23.3±15.0 months from completing studies, while non-industry funded trials reported within 18.9 ±10.8 months.<br /><b>Conclusions</b><br />Despite Black Americans carrying the highest burden of disease for essential hypertension, they are underrepresented in anti-hypertension clinical trials and their overall participation has decreased between 2010-2020. In addition, there is major underreporting of trial participant race. We implore researchers and funders to establish clear, meaningful targets for anti-hypertensive drug trial diversity, and improve transparency in reporting of study characteristics.<br /><br />Copyright © 2023 Elsevier Ltd. All rights reserved.<br /><br /><small>Am Heart J: 11 Jan 2023; epub ahead of print</small></div>
Green MD, Dalmage MR, Lusk JB, Kadhim EF, Skalla LA, O'Brien EC
Am Heart J: 11 Jan 2023; epub ahead of print | PMID: 36640861
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<div><h4>Feasibility and outcomes from using a commitment devices and text message reminders to increase adherence to time-restricted eating: A randomized trial.</h4><i>Fanaroff AC, Coratti S, Halaby R, Sanghavi M, ... Chokshi N, Patel M</i><br /><b>Background</b><br />Obesity is strongly associated with cardiovascular disease, particularly through its effects on blood pressure. Though maintaining a negative caloric balance leads to weight loss, many patients struggle to adhere to low calorie diets over the long term. Time-restricted eating, a subtype of intermittent fasting (IF), may be an easier dietary pattern for patients to initiate and maintain. We tested the feasibility of a bidirectional texting strategy to help patients with obesity and hypertension initiate and maintain time-restricted eating, and whether a commitment device, a pledge to behave in a certain way in the future while making non-adherence costlier, would increase adherence beyond bidirectional texting.<br /><b>Methods</b><br />Patients with obesity and hypertension seen in cardiology clinics were provided education on time-restricted eating and randomized to a commitment device versus attention control. Attention control consisted of daily bidirectional text messages asking whether patients adhered to IF and weekly text messages asking participants to send their weight and blood pressure. The commitment device involved the same text messages as attention control, plus a commitment contract, setting of implementation intentions with respect to details of time-restricted eating, and involvement of a support partner who received weekly updates on the participant\'s adherence to time-restricted eating. The intervention lasted 12 weeks, followed by a 6-week follow-up period. The primary outcome was days per week adherent to time-restricted eating over the 18-week study period, measured by daily self-report. We also compared change from baseline weight and blood pressure between randomized groups.<br /><b>Results</b><br />A total of 37 patients were randomized and started the study - 20 to attention control and 17 to the commitment device. Mean age was 60 years old, and mean BMI was 38.4 kg/m<sup>2</sup>. Over the 18-week study period, the mean ± standard deviation (SD) number of days per week adherent to time-restricted eating was 4.7 ± 1.9 in the control arm and 5.4 ± 1.7 in the intervention arm (p = 0.23). Mean systolic blood pressure declined from 135 to 128 mm Hg among all participants (p = 0.006) with no difference between groups in change from baseline blood pressure (p = 0.74). Weight decreased from 229 to 223 pounds among all participants (p = 0.25) with no significant difference between groups in change from baseline weight (p = 0.84).<br /><b>Conclusion</b><br />A bidirectional texting strategy was feasible for helping patients with obesity and hypertension initiate and adhere to time-restricted eating. Adding a commitment device to bidirectional texting did not increase adherence to time-restricted eating compared with attention control, nor were there significant between group changes in blood pressure or weight, but these comparisons were underpowered. A larger randomized trial of the effect of this scalable intervention, compared with usual care, on blood pressure and weight among patients with obesity and hypertension is warranted.<br /><b>Clinical trials registration</b><br />clinicaltrials.gov; unique identifier: NCT04836312.<br /><br />Copyright © 2023 Elsevier Ltd. All rights reserved.<br /><br /><small>Am Heart J: 11 Jan 2023; epub ahead of print</small></div>
Fanaroff AC, Coratti S, Halaby R, Sanghavi M, ... Chokshi N, Patel M
Am Heart J: 11 Jan 2023; epub ahead of print | PMID: 36640862
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<div><h4>Sex-stratified differences in early antithrombotic treatment response in patients presenting with ST-segment elevation myocardial infarction.</h4><i>Delewi R, Vogel RF, Wilschut JM, Lemmert ME, ... Smits PC, Vlachojannis GJ</i><br /><b>Aims</b><br />The mechanisms underlying the increased risk of bleeding that female patients with ST-segment Elevation Myocardial Infarction (STEMI) exhibit, remains unclear. The present report assessed sex-related differences in response to pre-hospital dual antiplatelet therapy (DAPT) initiation in patients with STEMI.<br /><b>Methods and results</b><br />The COMPARE CRUSH trial randomized patients presenting with STEMI to receive a pre-hospital loading dose of crushed or integral prasugrel tablets in the ambulance. In this substudy, we compared platelet reactivity levels and the occurrence of high platelet reactivity (HPR; defined as platelet reactivity ≥208) between sexes at four prespecified time points after DAPT initiation, and evaluated post-PCI bleeding between groups. Out of 633 STEMI patients, 147 (23%) were female. Females compared with males presented with significantly higher levels of platelet reactivity and higher HPR rates at baseline (232 [IQR, 209-256] vs. 195 [IQR, 171-220], p<0.01, and 76% vs. 41%, OR 4.58 [95%CI, 2.52-8.32], p<0.01, respectively). Moreover, female sex was identified as the sole independent predictor of HPR at baseline (OR 5.67 [95%CI, 2.56-12.53], p<0.01). Following DAPT initiation, levels of platelet reactivity and the incidence of HPR were similar between sexes. Post-PCI bleeding occurred more frequently in females compared with males (10% vs.2%, OR 6.02 [95%CI, 2.61-11.87], p<0.01). Female sex was an independent predictor of post-PCI bleeding (OR 3.25 [95%CI, 1.09-9.72], p=0.04).<br /><b>Conclusion</b><br />In this contemporary STEMI cohort, female STEMI patients remain at risk of bleeding complications after primary PCI. However, this is not explained by sex-specific differences in the pharmacodynamic response to pre-hospital DAPT initiation.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 31 Dec 2022; epub ahead of print</small></div>
Delewi R, Vogel RF, Wilschut JM, Lemmert ME, ... Smits PC, Vlachojannis GJ
Am Heart J: 31 Dec 2022; epub ahead of print | PMID: 36596332
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<div><h4>Association of ACEI/ARB and Statin Prescribing Patterns with Mortality After Transcatheter Aortic Valve Replacement (TAVR): Findings from Real-World Claims Data.</h4><i>Cubeddu RJ, Murphy SME, Asher CR, Garcia SA, ... Thourani VH, Leon MB</i><br /><b>Background</b><br />Transcatheter aortic valve replacement (TAVR) has become the standard of care for most patients with severe aortic stenosis (AS), but the impact of medical therapy prescribing patterns on post-TAVR patients has not been thoroughly investigated.<br /><b>Methods</b><br />We analyzed Optum® claims data from 9,012 adults who received TAVR for AS (January 2014-December 2018). Pharmacy claims data were used to identify patients who filled ACEI/ARB and/or statin prescriptions during the study\'s 90-day landmark period post-TAVR. Kaplan-Meier and adjusted Cox Proportional Hazards models were used to evaluate the association of prescribing patterns with mortality during the 3-year follow-up period. Subgroup analyses were performed to examine the impact of 11 potential confounders on the observed associations.<br /><b>Results</b><br />A significantly lower adjusted 3-year mortality was observed for patients with post-TAVR prescription for ACEI/ARBs (hazard ratio [HR]=0.82, 95% confidence interval [CI] 0.74-0.91, p=0.0003) and statins (HR=0.85, 95% CI 0.77-0.94, p=0.0018) compared to patients who did not fill prescriptions for these medications post-TAVR. Subgroup analyses revealed that the survival benefit associated with ACEI/ARB prescription was not affected by any of the potential confounding variables, except preoperative ACEI/ARB prescription was associated with significantly lower risk of mortality vs postoperative prescription only. No other subgroup variables had significant interactions associated with survival benefits, including preoperative use of statins.<br /><b>Conclusions</b><br />In this large-scale, real-world analysis of patients undergoing TAVR, the prescription of ACEI/ARB and statins was associated with a significantly lower risk of mortality at 3-years, especially in those where these medications were initiated preoperatively.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 31 Dec 2022; epub ahead of print</small></div>
Cubeddu RJ, Murphy SME, Asher CR, Garcia SA, ... Thourani VH, Leon MB
Am Heart J: 31 Dec 2022; epub ahead of print | PMID: 36596333
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<div><h4>Pre-hospital treatment with zalunfiban (RUC-4) in patients with ST- Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: Rationale and design of the CELEBRATE trial.</h4><i>Rikken SAOF, Selvarajah A, Hermanides RS, Coller BS, ... van \'t Hof AWJ, CELEBRATE investigators</i><br /><b>Background</b><br />Early and complete restoration of target vessel patency in ST-elevation myocardial infarction (STEMI) is associated with improved outcomes. Oral P2Y<sub>12</sub> inhibitors have failed to demonstrate either improved patency or reduced mortality when administered in the pre-hospital setting. Thus, there is a need for antiplatelet agents that achieve prompt and potent platelet inhibition, and that restore patency in the pre-hospital setting. Zalunfiban, a novel subcutaneously administered glycoprotein IIb/IIIa inhibitor designed for pre-hospital administration, has shown to achieve rapid, high-grade platelet inhibition that exceeds that of P2Y<sub>12</sub> inhibitors. Whether pre-hospital administration of zalunfiban can improve clinical outcome is unknown.<br /><b>Hypothesis</b><br />The present study is designed to assess the hypothesis that a single, pre-hospital injection of zalunfiban given in the ambulance, in addition to standard-of-care in patients with STEMI with intent to undergo primary percutaneous coronary intervention (PCI) will improve clinical outcome compared to standard-of-care with placebo.<br /><b>Study design</b><br />The ongoing CELEBRATE trial (NCT04825743) is a phase III, randomized, double-blinded, placebo-controlled, international trial. Patients with STEMI intended to undergo primary PCI will receive treatment with a single subcutaneous injection containing either zalunfiban dose 1 (0.110 mg/kg), zalunfiban dose 2 (0.130 mg/kg) or placebo, and the study drug will be administered in the ambulance before transportation to the hospital. A target of 2499 patients will be randomly assigned to one of the treatment groups in a 1:1:1 ratio, i.e., to have approximately 833 evaluable patients per group. The primary efficacy outcome is a ranked 7-point scale on clinical outcomes. The primary safety outcome is severe or life-threatening bleeding according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria.<br /><b>Summary</b><br />The CELEBRATE trial will assess whether a single pre-hospital subcutaneous injection of zalunfiban in addition to standard-of-care in patients with STEMI with intent to undergo primary PCI will result in improved clinical outcome.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 30 Dec 2022; epub ahead of print</small></div>
Rikken SAOF, Selvarajah A, Hermanides RS, Coller BS, ... van 't Hof AWJ, CELEBRATE investigators
Am Heart J: 30 Dec 2022; epub ahead of print | PMID: 36592878
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<div><h4>Pursuing Functional Biomarkers in Complex Disease: Focus on Pulmonary Arterial Hypertension.</h4><i>Benincasa G, Napoli C, Loscalzo J, Maron BA</i><br /><AbstractText>A major gap in diagnosis, classification, risk stratification, and prediction of therapeutic response exists in pulmonary arterial hypertension (PAH), driven in part by a lack of functional biomarkers that are also disease-specific. In this regard, leveraging big data -omics analyses using innovative approaches that integrate network medicine and machine learning correlated with clinically useful indices or risk stratification scores is an approach well-positioned to advance PAH precision medicine. For example, machine learning applied to a panel of 48 cytokines, chemokines, and growth factors could prognosticate PAH patients with immune-dominant subphenotypes at elevated or low-risk for mortality. Here, we discuss strengths and weaknesses of the most current studies evaluating omics-derived biomarkers in PAH. Progress in this field is offset by studies with small sample size, pervasive limitations in bioinformatics, and lack of standardized methods for data processing and interpretation. Future success in this field, in turn, is likely to hinge on mechanistic validation of data outputs in order to couple functional biomarker data with target-specific therapeutics in clinical practice.</AbstractText><br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 21 Dec 2022; epub ahead of print</small></div>
Benincasa G, Napoli C, Loscalzo J, Maron BA
Am Heart J: 21 Dec 2022; epub ahead of print | PMID: 36565787
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<div><h4>Predicted lean body mass, fat mass, and heart failure in patients with type 2 diabetes mellitus.</h4><i>Tang X, Lingzhu Y, Xing Z</i><br /><b>Background</b><br />High body mass index (BMI) is associated with a higher risk of heart failure (HF) in patients with new-onset type 2 diabetes mellitus (T2DM). However, limited studies have investigated the independent association between fat mass or lean body mass and HF risk among T2DM patients with cardiovascular disease (CVD) or high CVD risk.<br /><b>Objectives</b><br />To investigate the association between fat mass index (FMI, kg/m<sup>2</sup>) or lean BMI (LBMI, kg/m<sup>2</sup>) and HF risk.<br /><b>Methods</b><br />This was a post hoc analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. Cox proportional-hazards models were applied to evaluate the association of FMI, LBMI, and BMI with HF risk. Discordant analysis was performed to compare the magnitude of this associations.<br /><b>Results</b><br />HF occurred in 356 participants (3.7%). After adjusting for confounding factors, higher FMI values were independently associated with HF risk (HR: 1.72, 95% CI: 1.15-2.57, each one SD increase in FMI); LBMI was a protective risk factor for HF (HR: 0.58, 95% CI: 0.38-0.87,). After further adjusting for FMI, the association between BMI and HF risk (HR, 0.97; 95% CI, 0.67-1.42) disappeared. Compared with concordant values below the medians, discordant FMI above the median with BMI below yielded an HR of 1.78 (95% CI: 1.14-2.78) for HF. In contrast, BMI above the median with FMI below was not associated with HF risk (HR: 1.09, 95% CI: 0.57-2.09).<br /><b>Conclusions</b><br />The risk of HF conferred by higher BMI was primarily driven by the association between FMI and HF. After adjusting for BMI, LBMI played a protective role.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 14 Dec 2022; epub ahead of print</small></div>
Tang X, Lingzhu Y, Xing Z
Am Heart J: 14 Dec 2022; epub ahead of print | PMID: 36528115
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<div><h4>Imaging in atrial fibrillation: a way to assess atrial fibrosis and remodeling to assist decision-making.</h4><i>López-Galvez R, Rivera-Caravaca JM, Roldán V, Orenes-Piñero E, ... Lip GYH, Marín F</i><br /><AbstractText>The 2020 ESC atrial fibrillation (AF) guidelines suggest the novel 4S-AF scheme for the characterization of AF. Imaging techniques could be helpful for this objective in everyday clinical practice, and information derived from these techniques reflects basic aspects of the pathophysiology of AF, which may facilitate treatment decision-making, and optimal management of AF patients. The aim of this review is to provide an overview of the mechanisms associated with atrial fibrosis and to describe imaging techniques that may help the management of AF patients in clinical practice. Transthoracic echocardiography is the most common procedure given its versatility, safety, and simplicity. Transesophageal echocardiography provides higher resolution exploration, and speckle tracking echocardiography can provide incremental functional and prognostic information over conventional echocardiographic parameters. In addition, LA deformation imaging, including LA strain and strain rate, are related to the extent of fibrosis. On the other hand, multidetector-row computed tomography and cardiac magnetic resonance provide higher resolution data and more accurate assessment of the dimensions, structure, and spatial relationships of the LA. Imaging is central when deciding on catheter ablation or cardioversion, and helps in selecting those patients who will really benefit from these procedures. Moreover, imaging enhances the understanding of the underlying mechanisms of atrial remodeling and might assists in refining the risk of stroke, which help to select the best medical therapies/interventions. In summary, evaluation of LA enlargement, LA remodeling and fibrosis with imaging techniques adds clinical and prognostic information and should be assessed as a part of routine comprehensive AF evaluation.</AbstractText><br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 13 Dec 2022; epub ahead of print</small></div>
López-Galvez R, Rivera-Caravaca JM, Roldán V, Orenes-Piñero E, ... Lip GYH, Marín F
Am Heart J: 13 Dec 2022; epub ahead of print | PMID: 36526006
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<div><h4>Impact of coronary disease patterns, anatomical factors, micro-vascular disease and non-coronary cardiac factors on invasive coronary physiology.</h4><i>Ekmejian A, Allahwala U, Ward M, Bhindi R</i><br /><AbstractText>Invasive coronary physiology has been applied by interventional cardiologists to guide the management of coronary artery disease (CAD), with well-defined thresholds applied to determine whether CAD should be managed with optimal medical therapy (OMT) alone or OMT and percutaneous coronary intervention (PCI). There are multiple modalities in clinical use, including hyperaemic and non-hyperaemic indices. Despite endorsement in the major guidelines, there are various factors which impact and confound the readings of invasive coronary physiology, both within the coronary tree and beyond. This review article aims to summarise the mechanisms by which these factors impact invasive coronary physiology, and distinguish factors that contribute to ischaemia from confounding factors. The potential for mis-classification of ischaemic status is highlighted. Lastly, the authors identify targets for future research to improve the precision of physiology-guided management of CAD.</AbstractText><br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 09 Dec 2022; epub ahead of print</small></div>
Ekmejian A, Allahwala U, Ward M, Bhindi R
Am Heart J: 09 Dec 2022; epub ahead of print | PMID: 36509137
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<div><h4>Early treatment with a sodium-glucose co-transporter 2 inhibitor in high-risk patients with acute heart failure: rationale for and design of the EMPA-AHF trial.</h4><i>Horiuchi Y, Matsue Y, Nogi K, Onitsuka K, ... Voors AA, Kitai T</i><br /><b>Aims</b><br />The aim of the EMPA-AHF trial is to clarify whether early initiation of a sodium-glucose co-transporter 2 inhibitor before clinical stabilization is safe and beneficial for patients with acute heart failure (AHF) who are at a high risk of adverse events.<br /><b>Methods</b><br />The EMPA-AHF trial is a randomized, double-blind, placebo-controlled, multicentre trial examining the efficacy and safety of early initiation of empagliflozin (10 mg once daily). In total, 500 patients admitted for AHF will be randomized 1:1 to either empagliflozin 10 mg daily or placebo at 47 sites in Japan. Study entry requires hospitalization for AHF with dyspnoea, signs of volume overload, elevated natriuretic peptide, and at least one of the following criteria: estimated glomerular filtration rate <60 mL/min/1.73 m<sup>2</sup>; already taking ≥40 mg of furosemide daily before hospitalization; and urine output of <300 mL within 2 hours after an adequate dose of intravenous furosemide. Patients will be randomized within 12 hours of hospital presentation, with treatment continued up to 90 days. The primary outcome is the clinical benefit of empagliflozin on the win ratio for a hierarchical composite endpoint consisting of death within 90 days, heart failure rehospitalization within 90 days, worsening heart failure during hospitalization, and urine output within 48 hours after treatment initiation.<br /><b>Conclusion</b><br />The EMPA-AHF trial is the first to evaluate the efficacy and safety of early initiation of empagliflozin in patients with AHF considered to be at high risk under conventional treatment.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 08 Dec 2022; epub ahead of print</small></div>
Horiuchi Y, Matsue Y, Nogi K, Onitsuka K, ... Voors AA, Kitai T
Am Heart J: 08 Dec 2022; epub ahead of print | PMID: 36503007
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<div><h4>Rationale and design of the Effects of intensive Systolic blood Pressure lowering treatment in reducing RIsk of vascular evenTs (ESPRIT): a multicenter open-label randomized controlled trial.</h4><i>Liu J, Wang B, Li Y, Yan X, Ge J, Li J</i><br /><b>Background</b><br />Lowering blood pressure (BP) effectively reduces the risk of cardiovascular (CV) events in high CV risk individuals. The optimal target of BP lowering among high CV risk individuals remains unclear.<br /><b>Methods</b><br />The Effects of intensive Systolic blood Pressure lowering treatment in reducing RIsk of vascular evenTs (ESPRIT) trial is a multi-center, open-label, randomized controlled trial to compare the efficacy and safety of intensive BP lowering strategy (Systolic BP target <120 mmHg) and standard BP lowering strategy (Systolic BP target <140 mmHg). Participants aged at least 50 years old with baseline systolic BP within 130-180 mmHg at high CV risk, defined by established CV diseases or two major CV risk factors, were enrolled. The primary outcome is a composite CV outcome of myocardial infarction, coronary or non-coronary revascularization, hospitalization or emergency department visit from new-onset heart failure or acute decompensated heart failure, stroke, or death from CV diseases. Secondary outcomes include components of the primary composite outcome, all-cause death, a composite of the primary outcome or all-cause death, kidney outcomes, as well as cognitive outcomes.<br /><b>Results</b><br />Despite of the interruption of COVID-19 outbreak, the ESPRIT trial successfully enrolled and randomized 11,255 participants from 116 hospitals or primary health care institutions. The mean age of the participants was 64.6 (standard deviation [SD], 7.1) years, 4,650 (41.3%) were women. Among them 28.9%, 26.9% and 38.7% had coronary heart disease, prior stroke and diabetes mellitus, respectively. COVID-19 outbreak affected the BP lowering titration process of the trial, and delayed the reach of BP target.<br /><b>Conclusion</b><br />The ESPRIT trial will address the important question on the optimal BP lowering target for individuals with high CV risk, and generate high quality evidence for treating millions of patients from East Asian countries.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 06 Dec 2022; epub ahead of print</small></div>
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<div><h4>Evaluation of Huawei Smart Wearables for Detection of Atrial Fibrillation in Patients Following Ischaemic Stroke: The Liverpool-Huawei Stroke Study.</h4><i>Harrison SL, Buckley BJR, Zheng Y, Hill A, ... Jones I, Liverpool-Huawei Stroke Study Investigators</i><br /><AbstractText>Atrial fibrillation (AF) often remains undetected following stroke. Documenting AF is critical to initiate oral anticoagulation, which has proven benefit in reducing recurrent stroke and mortality in patients with AF. The accuracy and acceptability of using smart wearables technology to detect AF in patients following stroke is unknown. The aims of the Liverpool-Huawei Stroke Study are to determine the effectiveness, cost-effectiveness and patient and staff acceptability of using Huawei smart wearables to detect AF following ischaemic stroke. The study plans to recruit 1000 adults aged ≥18 years following ischaemic stroke from participating hospitals over 12 months. All participants will be asked to wear a Huawei smart band for four weeks post-discharge. If participants do not have access to a compatible smartphone required for the study, they will be provided with a smartphone for the four-week AF monitoring period. Participants with suspected AF detected by the smart wearables, without previous known AF, will be referred for further evaluation. To determine the effectiveness of the Huawei smart wearables to detect AF, the positive predictive value will be determined. Patient acceptability of using this technology will also be examined. Additional follow-up assessments will be conducted at six and 12 months, and clinical outcomes recorded in relation to prevalent and incident AF post-stroke. The study opened for recruitment on 30/05/2022, and is currently open at four participating hospitals; the first 106 participants have been recruited. One further hospital is preparing to open for recruitment. This prospective study will examine the effectiveness and acceptability of the use of smart wearables in patients following ischaemic stroke. This could have important implications for detection of AF and therefore, earlier prophylaxis for recurrent stroke. The study is registered on https://www.isrctn.com/ (Identifier ISRCTN30693819).</AbstractText><br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 06 Dec 2022; epub ahead of print</small></div>
Harrison SL, Buckley BJR, Zheng Y, Hill A, ... Jones I, Liverpool-Huawei Stroke Study Investigators
Am Heart J: 06 Dec 2022; epub ahead of print | PMID: 36493841
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<div><h4>Pragmatic Trial of Messaging to Providers About Treatment of Acute Heart Failure: The PROMPT-AHF Trial.</h4><i>Ghazi L, O\'Connor K, Yamamoto Y, Fuery M, ... Desai NR, Ahmad T</i><br /><AbstractText>Acute Heart failure (AHF) is among the most frequent causes of hospitalization in the United States, contributing to substantial healthcare costs, morbidity, and mortality. Inpatient initiation of guideline-directed medical therapy (GDMT) is recommended for patients with heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death or HF hospitalization. However, underutilization of GDMT prior to discharge is pervasive, representing a valuable missed opportunity to optimize evidence-based care. The PRagmatic Trial Of Messaging to Providers about Treatment of Acute Heart Failure (PROMPT-AHF) tests the effectiveness of an electronic health record embedded clinical decision support system that informs providers during hospital management about indicated but not yet prescribed GDMT for eligible AHF patients with HFrEF. PROMPT-AHF is an open-label, multicenter, pragmatic randomized controlled trial of 1,012 patients hospitalized with HFrEF. Eligible patients randomized to the intervention group are exposed to a tailored best practice advisory embedded within the electronic health record that alerts providers to prescribe omitted GDMT. The primary outcome is an increase in the proportion of additional GDMT medication classes prescribed at the time of discharge compared to those in the usual care arm.</AbstractText><br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 06 Dec 2022; epub ahead of print</small></div>
Ghazi L, O'Connor K, Yamamoto Y, Fuery M, ... Desai NR, Ahmad T
Am Heart J: 06 Dec 2022; epub ahead of print | PMID: 36493842
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<div><h4>Long-term antithrombotic therapy after coronary artery bypass grafting in patients with preoperative atrial fibrillation. A nationwide observational study from the SWEDEHEART registry.</h4><i>Skibniewski M, Venetsanos D, Ahlsson A, Batra G, ... Jeppsson A, Alfredsson J</i><br /><b>Aims</b><br />To provide data guiding long-term antithrombotic therapy after coronary artery by-pass grafting (CABG) in patients with preoperative atrial fibrillation (AF).<br /><b>Methods and results</b><br />From the SWEDEHEART registry, we included all patients, between January 2006 and September 2016, with preoperative AF and CHA<sub>2</sub>DS<sub>2</sub>-VASC score ≥2, undergoing CABG. Based on dispensed prescriptions 12-18 months after CABG, patients were divided in three groups: platelet inhibitors (PI) only, oral anticoagulant (OAC) only or a combination of OAC + PI. Outcomes were: Major adverse cardiac and cerebrovascular events (MACCE, [all-cause death, myocardial infarction, or stroke]), net adverse clinical events (NACE, [MACCE or bleeding]) and the individual components of NACE. Inverse probability of treatment weighting was used to adjust for the non-randomized study design. Among 2,564 patients, 1,040 (41%) were treated with PI alone, 1,064 (41%) with OAC alone, and 460 (18%) with PI+OAC. Treatment with PI alone was associated with higher risk for MACCE (adjusted HR 1.43, 95% CI 1.09- 1.88), driven by higher risk for stroke and MI, compared to OAC alone. Treatment with PI+OAC, was associated with higher risk for NACE (adjusted HR 1.40, 95% CI 1.06-1.85), driven by higher risk for bleeds, compared to OAC alone.<br /><b>Conclusion</b><br />In this real-world observational study, a high proportion of patients with AF, undergoing CABG, did not receive long-term OAC therapy. Treatment with OAC alone was associated with a net clinical benefit, compared with PI alone or PI + OAC.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 05 Dec 2022; epub ahead of print</small></div>
Skibniewski M, Venetsanos D, Ahlsson A, Batra G, ... Jeppsson A, Alfredsson J
Am Heart J: 05 Dec 2022; epub ahead of print | PMID: 36481448
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<div><h4>The rationale, design, and methods of a trial to evaluate the efficacy and safety of oxygen therapy in patients with intermediate-risk acute pulmonary embolism.</h4><i>Durán D, Barrios D, Moisés J, Retegui A, ... Jiménez D, AIR investigators</i><br /><b>Introduction</b><br />In patients with intermediate-risk pulmonary embolism (PE), reversal of hypoxic vasoconstriction could constitute a target for treatment that protects the right ventricular (RV) function until endogenous fibrinolysis occurs. The Air versus oxygen for Intermediate-Risk pulmonary embolism (AIR) trial aims to assess the effect of oxygen therapy in patients with intermediate-risk acute PE who do not have hypoxemia at baseline.<br /><b>Methods and analyses</b><br />AIR is a prospective, multicenter, randomized, open-label, parallel-group, proof-of-concept trial. A total of 90 patients hospitalized with intermediate-risk PE and an oxygen saturation of 90% or higher at baseline will be randomized in a 1:1 fashion to receive supplemental oxygen or ambient air. The primary outcome is a RV/LV diameter ratio equal or less than 1.0 on echocardiography measured 48 hours after the start of treatment. Secondary efficacy outcomes are the numerical change in the ratio of the RV to the LV diameter measured 48 hours and 7 days after the start of treatment, with respect to the baseline ratio measured at randomization. Clinical adverse events will be also collected.<br /><b>Results</b><br />Enrollment started in July 2019 and is expected to proceed until 2022. Median age of the first 50 patients was 74 years (interquartile range, 61-81), and 50% were female.<br /><b>Conclusions</b><br />This multicenter trial will provide information about the value of supplemental oxygen in patients with intermediate-risk acute PE who do not have hypoxemia at baseline. The results will contribute to research that may assist patients with intermediate-risk PE in the future.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 24 Nov 2022; epub ahead of print</small></div>
Durán D, Barrios D, Moisés J, Retegui A, ... Jiménez D, AIR investigators
Am Heart J: 24 Nov 2022; epub ahead of print | PMID: 36436613
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<div><h4>Rationale and design of BROKEN-SWEDEHEART: a registry-based, randomized, parallel, open-label multicenter trial to test pharmacological treatments for broken heart (takotsubo) syndrome.</h4><i>Omerovic E, James S, Erlinge D, Hagström H, ... Hambreus K, Redfors B</i><br /><b>Background</b><br />Takotsubo syndrome (TS) is a life-threatening acute heart failure syndrome without any evidence-based treatment options. No treatment for TS has been examined in a randomized trial.<br /><b>Study</b><br />design and objectives BROKEN-SWEDEHEART is a multicenter, randomized, open-label, registry-based 2 × 2 factorial clinical trial in patients with TS designed to test whether treatment with adenosine and dipyridamole accelerates cardiac recovery and improves clinical outcomes compared to standard care (study 1); and apixaban reduces the risk of thromboembolic events compared to no treatment with antithrombotic drugs (study 2). The trial will enroll 1000 patients. Study 1 (adenosine hypothesis) will evaluate two co-primary endpoints: (1) wall motion score index at 48-96 hours (evaluated in the first 200 patients); and (2) the composite of death, cardiac arrest, need for mechanical assist device or heart failure hospitalization within 30 days or left ventricular ejection fraction <50% at 48-96 hours (evaluated in 1000 patients). The primary endpoint in study 2 (apixaban hypothesis) is the composite of death or thromboembolic events within 30 days or the presence of intraventricular thrombus on echocardiography at 48-96 hours.<br /><b>Conclusions</b><br />BROKEN-SWEDEHEART will be the first prospective randomized multicenter trial in patients with TS. It is designed as two parallel studies to evaluate whether adenosine accelerates cardiac recovery and improves cardiac function in the acute phase and the efficacy of anticoagulation therapy for preventing thromboembolic complications in TS. If either of its component studies is successful, the trial will provide the first evidence-based treatment recommendation in TS.<br /><br />Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>Am Heart J: 23 Nov 2022; epub ahead of print</small></div>
Omerovic E, James S, Erlinge D, Hagström H, ... Hambreus K, Redfors B
Am Heart J: 23 Nov 2022; epub ahead of print | PMID: 36435233
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<div><h4>International Randomized Trial on the Effect of Revascularization or Optimal Medical Therapy of Chronic Total Coronary Occlusions with Myocardial Ischemia - ISCHEMIA-CTO Trial - Rationale and Design.</h4><i>Råmunddal T, Holck EN, Karim S, Eftekhari A, ... Jakobsen L, Christiansen EH</i><br /><b>Background</b><br />Chronic total occlusions (CTO) are frequent among patients with coronary artery disease. Revascularization with percutaneous coronary intervention (PCI) is safe and feasible in experienced hands. However, randomized data are needed to demonstrate symptomatic as well as prognostic effect of CTO-PCI compared to optimal medical therapy alone.<br /><b>Methods and design</b><br />This trial aims to evaluate the effect of CTO PCI in patients with a CTO lesion and target vessel diameter ≥ 2.5 mm, and myocardial ischemia in the relevant territory. First, all patients are subjected to optimal medical therapy (OMT) for at least for 3 months and non-CTO lesions are managed according to guidelines. Subsequently, prior to randomization myocardial ischemia and quality of life (Seattle Questionnaire (SAQ)) is assessed. Patients are divided into two cohorts based on their SAQ score and randomized to either OMT alone or OMT and CTO-PCI. Cohort A is defined as Low- or asymptomatic patients with a quality-of-life score > 60 and/or CCS class < 2, and more than 10 % ischemia in the left ventricle (LV). Cohort B is symptomatic patients with a quality-of-life score < 60 or CCS class angina > 1 and at least ischemia in 5% of the LV. The primary end-point in cohort A is a composite of major adverse cardiac and cerebral events, hospitalization for heart failure and malignant ventricular arrhythmias. The primary endpoint in cohort B is difference in quality of life 6 months after randomization.<br /><b>Implications</b><br />This trial is designed to investigate if CTO-PCI improves QoL and MACCE. Both positive and negative outcome of the trial will affect future guidelines and recommendations on how to treat patients with CTO.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 21 Nov 2022; epub ahead of print</small></div>
Råmunddal T, Holck EN, Karim S, Eftekhari A, ... Jakobsen L, Christiansen EH
Am Heart J: 21 Nov 2022; epub ahead of print | PMID: 36423733
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<div><h4>Rationale and Design for the Myocardial Ischemia and Transfusion (MINT) Randomized Clinical Trial.</h4><i>Carson JL, Brooks MM, Chaitman BR, Alexander JH, ... Hébert PC, On-Behalf-Of-The-Mint-Investigators </i><br /><b>Background</b><br />Accumulating evidence from clinical trials suggests that a lower (restrictive) hemoglobin threshold (<8% g/dL) for red blood cell (RBC) transfusion, compared with a higher (liberal) threshold (≥10 g/dL) is safe. However, in anemic patients with acute myocardial infarction (MI), maintaining a higher hemoglobin level may increase oxygen delivery to vulnerable myocardium resulting in improved clinical outcomes. Conversely, RBC transfusion may result in increased blood viscosity, vascular inflammation, and reduction in available nitric oxide resulting in worse clinical outcomes. We hypothesize that a liberal transfusion strategy would improve clinical outcomes as compared to a more restrictive strategy.<br /><b>Methods</b><br />We will enroll 3500 patients with acute MI (type 1, 2, 4b or 4c) as defined by the Third Universal Definition of MI and a hemoglobin <10 g/dL at 144 centers in the United States, Canada, France, Brazil, New Zealand, and Australia. We randomly assign trial participants to a liberal or restrictive transfusion strategy. Participants assigned to the liberal strategy receive transfusion of RBCs sufficient to raise their hemoglobin to at least 10 g/dL. Participants assigned to the restrictive strategy are permitted to receive transfusion of RBCs if the hemoglobin falls below 8 g/dL or for persistent angina despite medical therapy. We will contact each participant at 30 days to assess clinical outcomes and at 180 days to ascertain vital status. The primary endpoint is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary endpoints include all-cause mortality at 30 days, recurrent adjudicated MI, and the composite outcome of all-cause mortality, nonfatal recurrent MI, ischemia driven unscheduled coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), or readmission to the hospital for ischemic cardiac diagnosis within 30 days. The trial will assess multiple tertiary endpoints.<br /><b>Conclusions</b><br />The MINT trial will inform RBC transfusion practice in patients with acute MI.<br /><br />Copyright © 2022 Elsevier Ltd. All rights reserved.<br /><br /><small>Am Heart J: 20 Nov 2022; epub ahead of print</small></div>
Carson JL, Brooks MM, Chaitman BR, Alexander JH, ... Hébert PC, On-Behalf-Of-The-Mint-Investigators
Am Heart J: 20 Nov 2022; epub ahead of print | PMID: 36417955
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<div><h4>BA lloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs: Design and Rationale of the BASELINE Trial.</h4><i>Nuis RJ, van Belle E, Teles R, Blackman D, ... Van Mieghem NM, BASELINE Investigators</i><br /><b>Background</b><br />Surgical aortic valve bioprostheses may degenerate over time and require redo intervention. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to redo surgery. The BAlloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs (BASELINE) trial was designed to compare the performance of the balloon-expandable SAPIEN-3 Ultra and the self-expanding EVOLUT PRO+ valve systems in symptomatic patients with a failing surgical bioprosthesis.<br /><b>Methods</b><br />The BASELINE trial is an investigator-initiated, non-funded, prospective, randomized, open-label, superiority trial enrolling a total of 440 patients in up to 50 sites in 12 countries in Europe and North-America. The primary endpoint is device success at 30-days defined by the Valve Academic Research Consortium-3 Criteria as the composite of technical success, freedom from mortality, freedom for surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication with an intended performance of the valve (mean gradient <20 mmHg and less than moderate aortic regurgitation). The co-primary endpoint at 1 year is defined as the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Independent Core Laboratories will conduct uniform analyses of echocardiography (pre-, post-, 1-year post-procedure), multi-sliced computed tomography (pre-, and if available post-procedure) and cine-fluoroscopy studies.<br /><b>Conclusions</b><br />The BASELINE trial is a head-to-head comparative trial investigating the two most used contemporary transcatheter heart valves for the treatment of a failing surgical aortic bioprosthesis. (ClinicalTrials.gov number NCT04843072).<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 18 Nov 2022; epub ahead of print</small></div>
Nuis RJ, van Belle E, Teles R, Blackman D, ... Van Mieghem NM, BASELINE Investigators
Am Heart J: 18 Nov 2022; epub ahead of print | PMID: 36410441
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<div><h4>Percutaneous Coronary Intervention of Native Coronary Artery versus Saphenous Vein Graft in Patients with Prior Coronary Artery Bypass Graft Surgery: Rationale and Design of the Multicenter, Randomized PROCTOR Trial.</h4><i>de Winter RW, Walsh SJ, Hanratty CG, Spratt JC, ... Knaapen P, PROCTOR Trial Research Group</i><br /><b>Background</b><br />Patients with prior coronary artery bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported.<br /><b>Study design</b><br />PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI >48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale).<br /><b>Conclusion</b><br />PROCTOR is the first randomized trial comparing an invasive strategy of native coronary artery PCI with SVG PCI in post-CABG patients presenting with SVG failure.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 18 Nov 2022; epub ahead of print</small></div>
de Winter RW, Walsh SJ, Hanratty CG, Spratt JC, ... Knaapen P, PROCTOR Trial Research Group
Am Heart J: 18 Nov 2022; epub ahead of print | PMID: 36410442
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<div><h4>Derivation and Validation of a High Sensitivity Troponin-T HEART Pathway.</h4><i>Snavely AC, Paradee BE, Ashburn NP, Allen BR, ... Stopyra JP, Mahler SA</i><br /><b>Background</b><br />The HEART Pathway is widely used for chest pain risk stratification but has yet to be optimized for high sensitivity troponin T (hs-cTnT) assays.<br /><b>Methods</b><br />We conducted a secondary analysis of STOP-CP, a prospective cohort study enrolling adult ED patients with symptoms suggestive of acute coronary syndrome at 8 sites in the United States (US). Patients had a 0- and 1-hour hs-cTnT measured and a HEAR score completed. A derivation set consisting of 729 randomly selected participants was used to derive a hs-cTnT HEART Pathway with rule-out, observation, and rule-in groups for 30-day cardiac death or myocardial infarction (MI). Optimal baseline and 1-hour troponin cutoffs were selected using generalized cross validation (GCV) to achieve a negative predictive value (NPV) >99% for rule out and positive predictive value (PPV) >60% or maximum Youden index for rule-in. Optimal 0-1-hour delta values were derived using GCV to maximize the NPV for the rule-out group and PPV for the rule-in group. The hs-cTnT HEART Pathway performance was validated in the remaining cohort (n=723).<br /><b>Results</b><br />Among the 1452 patients, 30-day cardiac death or MI occurred in 12.7% (184/1452). Within the derivation cohort the optimal hs-cTnT HEART Pathway classified 36.5% (266/729) into the rule-out group, yielding a NPV of 99.2% (95% CI: 98.2-100) for 30-day cardiac death or MI. The rule-in group included 15.4% (112/729) with a PPV of 55.4% (95% CI: 46.2-64.6). In the validation cohort, the hs-cTnT HEART Pathway ruled-out 37.6% (272/723), of which 2 had 30-day cardiac death or MI, yielding a NPV of 99.3% (95% CI: 98.3-100). The rule-in group included 14.5% (105/723), yielding a PPV of 57.1% (95% CI: 47.7-66.6).<br /><b>Conclusion</b><br />A novel hs-cTnT HEART Pathway with serial 0- and 1-hour hs-cTnT measures has high NPV and moderate PPV for 30-day cardiac death or MI.<br /><br />Copyright © 2022 Elsevier Inc. All rights reserved.<br /><br /><small>Am Heart J: 15 Nov 2022; epub ahead of print</small></div>
Snavely AC, Paradee BE, Ashburn NP, Allen BR, ... Stopyra JP, Mahler SA
Am Heart J: 15 Nov 2022; epub ahead of print | PMID: 36400184
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<div><h4>Cardiovascular Events in Patients with Coronary Artery Disease with and Without Myocardial Ischemia: Long-Term Follow-Up.</h4><i>de Carvalho FPC, Hueb W, Lima EG, Rezende PC, ... Ramires JAF, Filho RK</i><br /><b>Background</b><br />After the results of the ISCHEMIA Trial, the role of myocardial ischemia in the prognosis of coronary artery disease was under debate. We sought to comparatively evaluate the long-term prognosis of patients with multivessel CAD with or without documented myocardial ischemia.<br /><b>Methods</b><br />This is a single-center, retrospective, observational cohort study that included patients with CAD obtained from the research protocols database of \"The Medicine, Angioplasty or Surgery Study,\" the MASS Study Group. Patients were stratified according to the presence or absence of myocardial ischemia. Cardiovascular events (overall mortality and myocardial infarction) were tracked from the registry entry up to a median follow-up of 8.7 years. Myocardial ischemia was assessed at baseline by a functional test with or without imaging.<br /><b>Results</b><br />From 1995 to 2018, 2015 patients with multivessel CAD were included. Of these, 1001 presented with conclusive tests at registry entry, 790 (79%) presenting with ischemia and 211 (21%) without ischemia. The median follow-up was 8.7 years (IQR 4.04 to 10.07). The primary outcome occurred in 228 (28.9%) patients with ischemia and in 64 (30.3%) patients without ischemia (p<sub>log-rank</sub>=0.60). No significant interaction was observed with the presence of myocardial ischemia and treatment strategies in the occurrence of the combined primary outcome (p<sub>interation</sub>=0.14).<br /><b>Conclusions</b><br />In this sample, myocardial ischemia was not associated with a worse prognosis compared with no ischemia in patients with multivessel CAD. These results refer to debates about the role of myocardial ischemia in the occurrence of cardiovascular events.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 15 Nov 2022; epub ahead of print</small></div>
de Carvalho FPC, Hueb W, Lima EG, Rezende PC, ... Ramires JAF, Filho RK
Am Heart J: 15 Nov 2022; epub ahead of print | PMID: 36400185
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<div><h4>Impact of design characteristics among studies comparing coronary computed tomography angiography to noninvasive functional testing in chronic coronary syndromes.</h4><i>Spirito A, Sticchi A, Praz F, Gräni C, Messerli F, Siontis GC</i><br /><b>Background</b><br />Coronary computed tomography angiography (CCTA) is widely adopted to detect obstructive coronary artery disease (CAD) in patients with chronic coronary syndromes (CCS). However, it is unknown to which extent study-specific characteristics yield different conclusions.<br /><b>Methods</b><br />We summarized non-randomized and randomized studies comparing CCTA and noninvasive functional testing for CCS with information on the outcome of myocardial infarction (MI). We evaluated the differential effect according to study characteristics using random-effect meta-analysis with Hartung-Knapp-Sidik-Jonkman adjustments.<br /><b>Results</b><br />Fifteen studies (8 non-randomized, 7 randomized) were included. CCTA was associated with decrease in relative (odds ratio (OR) 0.54, 95%CI 0.47 to 0.62, p<0.001) and absolute MI risk (risk difference (RD) -0.4%, 95%CI -0.6 to -0.1, p=0.005). The results remained consistent among the non-randomized (RD -0.4%, 95%CI -0.7 to -0.1, p=0.029), but not among the randomized trials where there was no difference in the observed risk (RD 0.2%, 95%CI -0.6 to 0.1, p=0.158). CCTA was not associated with MI reduction in studies with clinical outcome definition (OR 0.77, 95%CI 0.41 to 1.44, p=0.212), research driven follow-up (OR 0.54, 95%CI 0.24 to 1.21, p=0.090), central event assessment (OR 0.63, 95%CI 0.21 to 1.86, p=0.207), outcome adjudication (OR 0.74, 95%CI 0.24 to 2.23, p=0.178), or at low-risk of bias (OR 0.74, 95%CI 0.24 to 2.23, p=0.178).<br /><b>Conclusions</b><br />Among studies of any design, CCTA was associated with lower risk of MI in CCS compared to noninvasive functional testing. This benefit was diminished among studies with clinical outcome definition, central outcome assessment/adjudication or at low-risk of bias.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 15 Nov 2022; epub ahead of print</small></div>
Spirito A, Sticchi A, Praz F, Gräni C, Messerli F, Siontis GC
Am Heart J: 15 Nov 2022; epub ahead of print | PMID: 36400186
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<div><h4>Incidence of sudden cardiac arrest and sudden cardiac death after unstable angina pectoris and myocardial infarction.</h4><i>Koivunen M, Tynkkynen J, Oksala N, Eskola M, Hernesniemi J</i><br /><b>Background</b><br />Sudden cardiac arrests (SCA) and sudden cardiac deaths (SCD) are believed to account for a large proportion of deaths due to cardiovascular causes. The purpose of this study is to provide comprehensive information on the epidemiology of SCAs and SCDs after acute coronary syndrome.<br /><b>Methods</b><br />The incidence of SCA (including SCDs) was studied retrospectively among 10,316 consecutive patients undergoing invasive evaluation for acute coronary syndrome (ACS) between 2007 and 2018 at Tays Heart Hospital (sole provider of specialized cardiac care for a catchment area of over 0.5 million residents). Baseline and follow-up information was collected by combining information from the hospital\'s electronic health records, death certificate data, and a full-disclosure review of written patient records and accounts of the circumstances leading to death.<br /><b>Results</b><br />During twelve years of follow-up, the cumulative incidence of SCAs (including SCDs) was 9.8% (0.8% annually) and that of SCDs 5.4% (0.5% annually). Cumulative incidence of SCAs in patients with ST-elevation myocardial infarction, non-ST-elevation myocardial infarction and unstable angina pectoris were: 11.9%,10.2% and 5.7% at twelve years. SCAs accounted for 30.5% (n = 528/1,732) of all deaths due to cardiovascular causes. The vast majority of SCAs (95.6%) occurred in patients without implantable cardioverter defibrillator (ICD) devices or among patients with no recurrent hospitalizations for coronary artery disease (89.1%).<br /><b>Conclusions</b><br />SCAs accounted for less than a third of all deaths due to cardiovascular causes among patients with previous ACS. Incidence of SCA is highest among STEMI and NSTEMI patients. After the hospital discharge, most of SCAs happen to NSTEMI patients.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 13 Nov 2022; epub ahead of print</small></div>
Koivunen M, Tynkkynen J, Oksala N, Eskola M, Hernesniemi J
Am Heart J: 13 Nov 2022; epub ahead of print | PMID: 36384178
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<div><h4>Rationale and Design of the Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure Trial (ARISE-HF) in Patients with High-Risk Diabetic Cardiomyopathy.</h4><i>Januzzi JL, Butler J, Prato SD, Ezekowitz JA, ... Perfetti R, Urbinati A</i><br /><AbstractText>Diabetic cardiomyopathy (DbCM) is a specific form of heart muscle disease that may result in substantial morbidity and mortality in individuals with type 2 diabetes mellitus (T2DM). Hyperactivation of the polyol pathway is one of the primary mechanisms in the pathogenesis of diabetic complications, including development of DbCM. There is an unmet need for therapies targeting the underlying metabolic abnormalities that drive this form of Stage B heart failure (HF). Aldose reductase (AR) catalyzes the first and rate-limiting step in the polyol pathway, and AR inhibition has been shown to reduce diabetic complications, including DbCM in animal models and in patients with DbCM. Previous AR inhibitors (ARIs) were limited by poor specificity resulting in unacceptable tolerability and safety profile. AT-001 is a novel investigational highly specific ARI with higher binding affinity and greater selectivity than previously studied ARIs. ARISE-HF (NCT04083339) is an ongoing Phase 3 randomized, placebo-controlled, double blind, global clinical study to investigate the efficacy of AT-001 (1000 mg twice daily [BID] and 1500 mg BID) in 675 T2DM patients with DbCM at high risk of progression to overt HF. ARISE-HF assesses the ability of AT-001 to improve or prevent decline in exercise capacity as measured by functional capacity (changes in peak oxygen uptake [peak VO<sub>2</sub>]) over 15 (and possibly 27) months of treatment. Additional endpoints include percentage of patients progressing to overt HF, health status metrics, echocardiographic measurements, and changes in cardiac biomarkers. This report describes the rationale and study design of ARISE-HF.</AbstractText><br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 10 Nov 2022; epub ahead of print</small></div>
Januzzi JL, Butler J, Prato SD, Ezekowitz JA, ... Perfetti R, Urbinati A
Am Heart J: 10 Nov 2022; epub ahead of print | PMID: 36372245
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<div><h4>Predicting Short-term Outcomes After Transcatheter Aortic Valve Replacement for Aortic Stenosis.</h4><i>Savitz ST, Leong T, Sung SH, Kitzman DW, ... Ambrosy AP, Go AS</i><br /><b>Background</b><br />The approved use of transcatheter aortic valve replacement (TAVR) for aortic stenosis has expanded substantially over time. However, gaps remain with respect to accurately delineating risk for poor clinical and patient-centered outcomes. Our objective was to develop prediction models for 30-day clinical and patient-centered outcomes after TAVR within a large, diverse community-based population.<br /><b>Methods</b><br />We identified all adults who underwent TAVR between 2013-2019 at Kaiser Permanente Northern California, an integrated healthcare delivery system, and were monitored for the following 30-day outcomes: all-cause death, improvement in quality of life, all-cause hospitalizations, all-cause emergency department (ED) visits, heart failure (HF)-related hospitalizations, and HF-related ED visits. We developed prediction models using gradient boosting machines using linked demographic, clinical and other data from the Society for Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry and electronic health records. We evaluated model performance using area under the curve (AUC) for model discrimination and associated calibration plots. We also evaluated the association of individual predictors with outcomes using logistic regression for quality of life and Cox proportional hazards regression for all other outcomes.<br /><b>Results</b><br />We identified 1,565 eligible patients who received TAVR. The risks of adverse 30-day post-TAVR outcomes ranged from 1.3% (HF hospitalizations) to 15.3% (all-cause ED visits). In models with the highest discrimination, discrimination was only moderate for death (AUC 0.60) and quality of life (AUC 0.62), but better for HF-related ED visits (AUC 0.76). Calibration also varied for different outcomes. Importantly, STS risk score only independently predicted death and all-cause hospitalization but no other outcomes. Older age also only independently predicted HF-related ED visits, and race/ethnicity was not significantly associated with any outcomes.<br /><b>Conclusions</b><br />Despite using a combination of detailed STS/ACC TVT Registry and electronic health record data, predicting short-term clinical and patient-centered outcomes after TAVR remains challenging. More work is needed to identify more accurate predictors for post-TAVR outcomes to support personalized clinical decision making and monitoring strategies.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 10 Nov 2022; epub ahead of print</small></div>
Savitz ST, Leong T, Sung SH, Kitzman DW, ... Ambrosy AP, Go AS
Am Heart J: 10 Nov 2022; epub ahead of print | PMID: 36372246
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Abstract
<div><h4>Relationships Between Neighborhood Disadvantage and Cardiovascular Findings at Autopsy in Subjects with Sudden Death.</h4><i>Cornelissen A, Guo L, Neally SJ, Kleinberg L, ... Virmani R, Finn AV</i><br /><b>Background</b><br />Neighborhood disadvantage is associated with a higher risk of sudden cardiac death. However, autopsy findings have never been investigated in this context. Here, we sought to explore associations between neighborhood disadvantage and cardiovascular findings at autopsy in cases of sudden death in the State of Maryland.<br /><b>Methods</b><br />State of Maryland investigation reports from 2,278 subjects within the CVPath Sudden Death Registry were screened for street addresses and 9-digit zip-codes. Area Deprivation Index (ADI), used as metric for neighborhood disadvantage, was available for 1,464 subjects; 650 of whom self-identified as Black and 814 as White. The primary study outcome measurements were causes of death and gross and histopathologic findings of the heart.<br /><b>Results</b><br />Subjects from most disadvantaged neighborhoods (i.e., ADI ≥8; n=607) died at younger age compared with subjects from less disadvantaged neighborhoods (i.e., ADI ≤7; n=857; 46.07±14.10 versus 47.78±13.86 years; p=0.02) and were more likely Black or women. They were less likely to die from cardiac causes of death (61.8% versus 67.7%; p=0.02) and had less severe atherosclerotic plaque features, including plaque burden, calcification, intraplaque hemorrhage, and thin-cap fibroatheromas. In addition, subjects from most disadvantaged neighborhoods had lower frequencies of plaque rupture (18.8% versus 25.1%, p=0.004). However, these associations were omitted after adjustment for traditional risk factors and race.<br /><b>Conclusion</b><br />Neighborhood disadvantage did not associate with cause of death or coronary histopathology after adjustment for cardiovascular risk factors and race, implying that social determinants of health other than neighborhood disadvantage play a more prominent role in sudden cardiac death.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 10 Nov 2022; epub ahead of print</small></div>
Cornelissen A, Guo L, Neally SJ, Kleinberg L, ... Virmani R, Finn AV
Am Heart J: 10 Nov 2022; epub ahead of print | PMID: 36372247
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Abstract
<div><h4>Effect of Cooling Methods and Target Temperature on Outcomes in Comatose Patients Resuscitated from Cardiac Arrest: Systematic Review and Network Meta-Analysis of Randomized Trials.</h4><i>Matsumoto S, Kuno T, Mikami T, Takagi H, ... Bangalore S, Alviar CL</i><br /><AbstractText>Targeted temperature management (TTM) has been recommended after cardiac arrest (CA), however the specific temperature targets and cooling methods (intravascular cooling (IVC) versus surface cooling (SC)) remain uncertain. PUBMED and EMBASE were searched until October 8, 2022 for randomized clinical trials (RCTs) investigating the efficacy of TTM after CA. The randomized treatment arms were categorized into the following 6 groups: 31-33°C IVC, 31-33°C SC, 34-36°C IVC, 34-36°C SC, strict normothermia or fever prevention (Strict NT or FP), and standard of care without TTM (No-TTM). The primary outcome was neurological recovery. P-score was used to rank the treatments, where a larger value indicates better performance. We identified 15 RCTs, involving 5,218 patients with CA. Compared to No-TTM as the reference, the other therapeutic options significantly improved neurological outcomes (versus No-TTM; 31-33°C IVC: RR=0.67, 95% CI 0.54-0.83; 31-33°C SC RR=0.73, 95% CI 0.61-0.87; 34-36°C IVC: RR=0.66, 95% CI 0.51-0.86; 34-36°C SC: RR=0.73, 0.59-0.90; Strict NT or FP: RR=0.75, 95% CI 0.62-0.90). Overall, 31-33°C IVC had the highest probability to be the best therapeutic option to improve outcomes (the ranking P-score of 0.836). As a subgroup analysis, the ranking P-score showed that IVC might be a better cooling method compared to SC (IVC versus SC P-score: 0.960 versus 0.670). In conclusion, hypothermia (31-36°C IVC and SC) and active normothermia (Strict-NT and Strict-FP) were associated with better neurological outcomes compared to No-TTM, with IVC having a greater probability of being the better cooling method than SC.</AbstractText><br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 10 Nov 2022; epub ahead of print</small></div>
Matsumoto S, Kuno T, Mikami T, Takagi H, ... Bangalore S, Alviar CL
Am Heart J: 10 Nov 2022; epub ahead of print | PMID: 36372248
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Abstract
<div><h4>Predicting left main stenosis in stable ischemic heart disease using logistic regression and boosted trees.</h4><i>Godoy LC, Farkouh ME, Austin PC, Shah BR, ... John Mancini GB, Ko DT</i><br /><b>Background</b><br />The ISCHEMIA trial showed similar cardiovascular outcomes of an initial conservative strategy as compared with invasive management in patients with stable ischemic heart disease without left main stenosis. We aim to assess the feasibility of predicting significant left main stenosis using extensive clinical, laboratory and non-invasive tests data.<br /><b>Methods</b><br />All adult patients who had stress testing prior to undergoing an elective coronary angiography for stable ischemic heart disease in Ontario, Canada, between April 2010 and March 2019, were included. Candidate predictors included comprehensive demographics, comorbidities, laboratory tests, and cardiac stress test data. The outcome was stenosis of 50% or greater in the left main coronary artery. A traditional model (logistic regression) and a machine learning algorithm (boosted trees) were used to build prediction models.<br /><b>Results</b><br />Among 150,423 patients included (mean age: 64.2 ± 10.6 years; 64.1% males), there were 9,225 (6.1%) with left main stenosis. The final logistic regression model included 24 predictors and 3 interactions, had an optimism-adjusted c-statistic of 0.72 and adequate calibration (optimism-adjusted Integrated Calibration Index 0.0044). These results were consistent in subgroups of males and females, diabetes and non-diabetes, and extent of ischemia. The boosted tree algorithm had similar accuracy, also resulting in a c-statistic of 0.72 and adequate calibration (Integrated Calibration Index 0.0054).<br /><b>Conclusions</b><br />In this large population-based study of patients with stable ischemic heart disease using extensive clinical data, only modest prediction of left main coronary artery disease was possible with traditional and machine learning modelling techniques.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 10 Nov 2022; epub ahead of print</small></div>
Godoy LC, Farkouh ME, Austin PC, Shah BR, ... John Mancini GB, Ko DT
Am Heart J: 10 Nov 2022; epub ahead of print | PMID: 36372249
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Abstract
<div><h4>Study Protocol and Baseline Characteristics of Randomized Trial for Evaluating Secondary Prevention Efficacy of Combination Therapy-Statin and Eicosapentaenoic Acid: RESPECT-EPA, The Combination of a Randomized Control Trial and an Observational Biomarker Study.</h4><i>Nishizaki Y, Miyauchi K, Iwata H, Inoue T, ... Sato T, Daida H</i><br /><b>Background</b><br />Omega-3 polyunsaturated fatty acids (PUFAs) have been a hot topic since the Japan EPA Lipid Intervention Study (JELIS), the first landmark study using a highly purified eicosapentaenoic acid (EPA), indicated that EPA could decrease the incidence of cardiovascular events. Over 20 years have passed since the JELIS was conducted, and the standard treatment for dyslipidemia has altered significantly since then. The JELIS subjects did not undertake the current risk management especially current standard statins and did not exclusively target secondary prevention patients. In addition, the subjects included are relatively high EPA population. Furthermore, the clinical implication of the plasma EPA/arachidonic acid (AA) ratio as a biomarker has not yet been validated. Therefore, the Randomized Trial for Evaluating the Secondary Prevention Efficacy of Combination Therapy - statin and EPA (RESPECT-EPA) was planned and is currently underway in Japan.<br /><b>Methods</b><br />The RESPECT-EPA comprises two parts: the open-label randomized controlled trial (RCT) and biomarker study (prospective cohort study design). The RCT included patients with a low EPA/AA ratio. These patients were then randomized to highly purified EPA (1800 mg/day) or control groups. The primary endpoint was cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, unstable angina pectoris, and clinically indicated coronary revascularization. The biomarker study assesses the EPA/AA ratio\'s usefulness as a biomarker for cardiovascular events prediction.<br /><b>Results</b><br />In the RCT, a total of 2460 patients were enrolled in 95 sites in Japan. Patients\' baseline characteristics were similar between intervention and control groups in the RCT. The baseline median EPA/AA ratio was 0.243 and 0.235, respectively. A total of 1314 patients were participated in the observational part, and the baseline median EPA/AA ratio was 0.577.<br /><b>Conclusions</b><br />After this study is completed, we will have further evidence on whether a highly purified EPA is effective in reducing cardiovascular events for secondary prevention or not, as well as whether if EPA/AA ratio is a predictor for future cardiovascular events.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 10 Nov 2022; epub ahead of print</small></div>
Abstract
<div><h4>Physical Activity and Relationship to Physical Function, Quality of Life, and Cognitive Function in Older Patients with Acute Decompensated Heart Failure.</h4><i>Nelson MB, Shiroma EJ, Kitzman DW, Duncan PW, ... Chen H, Pastva AM</i><br /><b>Background</b><br />Volitional physical activity level is predictive of a variety of health outcomes, but has not been examined in patients recently hospitalized for acute decompensated HF (ADHF).<br /><b>Methods</b><br />Ten to 14 days after index hospitalization for ADHF, 93 participants wore a wrist-mounted triaxial accelerometer (ActiGraph GT3X+) to objectively quantify sedentary behavior, light physical activity, and moderate-to-vigorous physical activity. Levels were compared to two groups of age-matched NHANES participants: healthy and chronic, stable HF. The relationship between physical activity levels and physical function [Short Physical Performance Battery (SPPB)], HF-specific quality-of-life (QOL) [Kansas City Cardiomyopathy Questionnaire (KCCQ)], and cognition [Montreal Cognitive Assessment (MOCA)] were examined.<br /><b>Results</b><br />ADHF participants accumulated a median 1008 (IQR 896,1109) mins of sedentary time, 88 (57,139) mins of light physical activity, and 10 (6,25) mins of moderate-to-vigorous physical activity per day. Sedentary time, light physical activity, or moderate-to-vigorous activity did not differ by sex or EF subtype. ADHF participants spent only 9% of awake time non-sedentary, compared to 34% and 27% for healthy adults and adults with chronic, stable HF, respectively. Among ADHF participants, SPPB, KCCQ, and MOCA scores did not differ among quartiles of total physical activity.<br /><b>Conclusions</b><br />Older patients recently hospitalized for ADHF have very low levels of physical activity and high levels of sedentary time, both of which may be potential targets for interventions in this high-risk population. Physical activity level was not significantly associated with objectively measured physical function, QOL, or cognition, suggesting that this measure provides independent information regarding the patient experience of living with HF.<br /><b>Registration</b><br />NCT02196038, https://clinicaltrials.gov/ct2/show/NCT02196038.<br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 10 Nov 2022; epub ahead of print</small></div>
Nelson MB, Shiroma EJ, Kitzman DW, Duncan PW, ... Chen H, Pastva AM
Am Heart J: 10 Nov 2022; epub ahead of print | PMID: 36372251
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Abstract
<div><h4>Men who live alone have worse anticoagulation control: A Danish registry study.</h4><i>Bonde AN, Bjerre J, Proietti M, Yh Lip G, Gislason G, Hlatky MA</i><br /><AbstractText>Men living alone may have particular difficulty in managing chronic medical conditions. Anticoagulation control, a sensitive indicator of self-management, was significantly worse among men living alone.</AbstractText><br /><br />Copyright © 2022. Published by Elsevier Inc.<br /><br /><small>Am Heart J: 09 Nov 2022; epub ahead of print</small></div>
Bonde AN, Bjerre J, Proietti M, Yh Lip G, Gislason G, Hlatky MA
Am Heart J: 09 Nov 2022; epub ahead of print | PMID: 36370885
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Abstract
<div><h4>Prognosis of acute coronary syndrome stratified by cancer type and status -A nationwide cohort study.</h4><i>Nouhravesh N, Strange JE, Tønnesen J, Holt A, ... Schou M, Lamberts MK</i><br /><b>Aim</b><br />To investigated the prognosis of the most prevalent cancers (breast-, gastrointestinal-, and lung cancer), according to cancer status (i.e., active-, non-active-, history of-, and no cancer), following first-time of acute coronary syndrome (ACS).<br /><b>Methods</b><br />Danish nationwide registers were used to identify patients with first-time ACS from 2000-2018. Patients were stratified according to cancer type and status. Hazard ratios (HR) estimated by adjusted Cox regression models for one-year all-cause mortality reported. Further absolute risks of one-year cardiovascular versus non-cardiovascular death and thirty-day cumulative incidence of coronary angiograms (CAG) was estimated, using the Aalen-Johansen non-parametric method, with competing risk of death.<br /><b>Results</b><br />We identified 150,478 (95.7%) with no cancer, 2,370 (1.5%) with history of cancer, 2,712 (1.7%) with non-active cancer and 1,704 (1.1%) with active cancer. Cancer patients were older with more comorbidities than patients with no cancer. When compared with no cancer, we found HRs (95% confidence intervals) of 1.71 (1.44-2.02), 2.47 (2.23-2.73) and 4.22 (3.87-4.60) correspondingly for active breast-, gastrointestinal-, and lung cancer. Increased HRs were also found for non-active cancers, but not for history of cancer. Cardiovascular disease was the leading cause of death in all patients. Among patients with active breast-, gastrointestinal-, and lung cancer 43%, 43%, and 31% underwent CAG, correspondingly, compared with 77% of patients without cancer.<br /><b>Conclusions</b><br />Active- and non-active cancers were associated with an increased 1-year all-cause mortality compared with patients with history of cancer and no cancer. Cardiovascular disease was the leading cause of death; notably CAG was less frequently performed in cancer patients.<br /><br />Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.<br /><br /><small>Am Heart J: 09 Nov 2022; epub ahead of print</small></div>
Nouhravesh N, Strange JE, Tønnesen J, Holt A, ... Schou M, Lamberts MK
Am Heart J: 09 Nov 2022; epub ahead of print | PMID: 36370886
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This program is still in alpha version.