Long-Term Efficacy and Safety of Acoramidis in ATTR-CM: Initial Report From the Open-Label Extension of the ATTRibute-CM Trial

Circulation, Ahead of Print. Background: In the phase 3 randomized controlled study, ATTRibute-CM, acoramidis, a transthyretin (TTR) stabilizer, demonstrated significant efficacy on the primary endpoint. Participants with transthyretin amyloid cardiomyopathy (ATTR-CM) who completed ATTRibute-CM were invited to enroll in an open-label extension study (OLE). We report efficacy and safety data of acoramidis in participants who completed ATTRibute-CM and enrolled in the ongoing OLE.Methods: Participants who previously received acoramidis through Month 30 (M30) in ATTRibute-CM continued to receive it (continuous acoramidis), and those who received placebo through M30 were switched to acoramidis (placebo to acoramidis). Participants who received concomitant tafamidis in ATTRibute-CM were required to discontinue it to be eligible to enroll in the OLE. Clinical efficacy outcomes analyzed through Month 42 (M42) included time to event for all-cause mortality (ACM) or first cardiovascular-related hospitalization (CVH), ACM alone, first CVH alone, ACM or recurrent CVH, change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP), 6-minute walk distance (6MWD), serum TTR, and the Kansas City Cardiomyopathy Questionnaire Overall Summary score (KCCQ-OS). Safety outcomes were analyzed through M42.Results: Overall, 438 of 632 participants in ATTRibute-CM completed treatment and 389 enrolled in the ongoing OLE (263 continuous acoramidis, 126 placebo to acoramidis). The hazard ratio (HR) (95% CI) for ACM or first CVH was 0.57 (0.46, 0.72) at M42 based on a stratified Cox proportional hazards model (P-value < 0.0001) favoring continuous acoramidis. Similar analyses were performed on ACM alone and first CVH alone, with HRs (95% CI) of 0.64 (0.47, 0.88) and 0.53 (0.41, 0.69), respectively, at M42. Treatment effects for NT-proBNP and 6MWD also favored continuous acoramidis. Upon initiation of open-label acoramidis in the placebo-to-acoramidis arm there was a prompt increase in serum TTR. Quality of life assessed by KCCQ-OS was well preserved in continuous acoramidis participants compared with the placebo to acoramidis participants. No new clinically important safety issues were identified in this long-term evaluation.Conclusions: Early initiation and continuous use of acoramidis in the ATTRibute-CM study through M42 of the ongoing OLE study was associated with sustained clinical benefits in a contemporary ATTR-CM cohort, with no clinically important safety issues newly identified.

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Novembre 2024

Abstract 4144555: Atrial Fibrillation Catheter Ablation among Patients with Mediastinal Radiation; Insight from The National Inpatient Database (2015-2020)

Circulation, Volume 150, Issue Suppl_1, Page A4144555-A4144555, November 12, 2024. Introduction/Background:Radiation therapy (RT) is one of the most common treatment modalities for mediastinal cancers. RT has multiple adverse cardiovascular effects and it has been identified as an independent risk factor for atrial fibrillation (AF). The efficacy of catheter ablation in AF is well established, however there is limited data on procedural safety and outcomes in patients with mediastinal cancers and history of radiationMethods:The National Inpatient Sample (NIS) was analyzed from 2015-2020 to identify admissions for AF catheter ablation among patients with previous history of mediastinal radiation exposure using the 10-PCS (International Classification of Diseases, procedure coding system) codes. Baseline characteristics were compared between the two groups and multivariate logistic regression was used to analyze hospitalization outcomes.Results:We identified 257,240 admissions for AF catheter ablation of which 1720 patients (0.67%) had a history of mediastinal radiation exposure. In the adjusted analysis, the odds of in-hospital mortality (aOR 0.639, 95% CI 0.34-1.20, p 0.1637), major complications (aOR 0.876, 95% CI 0.73-1.05, p 0.1443), any gastrointestinal or hematological complication (aOR 0.853, 95% CI 0.63-1.15, p 0.3017), renal complications (aOR 1.017, 95% CI 0.88-1.18, p 0.0509) were similar in both cohorts. The odds of any cardiovascular complication (aOR 0.825, 95% CI 0.70-0.97, p 0.0208) was lower and odds of any pulmonary complication (aOR 1.433, 95% CI 1.27-1.62, p

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Novembre 2024

Abstract 4148074: Radial Artery Pseudoaneurysm Following Transradial Cardiac Catheterization: A Systematic Review and Case Report

Circulation, Volume 150, Issue Suppl_1, Page A4148074-A4148074, November 12, 2024. Introduction/Background:Transradial cardiac catheterization (TRC) is recommended for patients with acute coronary syndrome over femoral artery catheterization. Randomized controlled trials show TRC has significantly lower rates of bleeding, vascular complications, and mortality in high-risk acute coronary syndrome patients. However, vascular complications like radial artery spasm, occlusion, arteriovenous fistula, perforation, and pseudoaneurysm (PSA) can still occur. Despite TRC’s widespread adoption, recent data summarizing radial artery pseudoaneurysm post-TRC is lacking.Research Question/HypothesisThis review aims to identify at-risk patients, present a case of catheterization-related radial artery pseudoaneurysm, and provide diagnostic and management insights. We hypothesize that older patients with hypertension are at higher risk and that early detection and management are associated with low complication rates.Methods/Approach:Systematic searches were conducted in PubMed, Web of Science, EMBASE, and CINAHL databases. Two researchers independently selected articles, extracted data, and evaluated study quality on RA PSA post-TRC (2003–2023). A third reviewer resolved conflicts. The Joanna Briggs Institute (JBI) tool was used to evaluate bias risk. Additionally, a case report is presented.Results:From 3,262 records, 43 studies were selected, involving 67 patients (58.8% female, median age 73.5 years). Hypertension (39.5%) and atrial fibrillation (27.9%) were the most common comorbidities. Percutaneous interventions like stenting and angioplasty caused 58.1% of cases; diagnostic catheterizations accounted for 37.2%. Ultrasonography diagnosed 83.7% of cases. Symptoms appeared a few hours to four months post-TRC, with pulsatile mass (21.4%) and swelling (14.3%) being the most common, and pain and ecchymosis at 2.4% each. More than half of the patients (51.2%) required surgical intervention, but 66.7% recovered without deficits. Severe complications were rare, affecting fewer than 5%.Conclusions:A literature review of 43 articles with 67 patients suggests older female patients with hypertension may be more prone to radial artery pseudoaneurysm post-TRC. It typically presents as a pulsatile, painful swelling detectable by ultrasound. This complication precludes the use of the radial artery as a conduit for coronary artery bypass grafting. The review highlights the importance of vigilant post-catheterization monitoring to enable early detection and treatment.

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Novembre 2024

Abstract 4135629: Grades and trends from the 2024 United States Report Card on Physical Activity for Children and Youth

Circulation, Volume 150, Issue Suppl_1, Page A4135629-A4135629, November 12, 2024. Background:Regular physical activity provides numerous health benefits including improved cardiovascular health. Population-level physical activity surveillance is critical for informing research, practice, and policy efforts for supporting population health and health disparities. The United States Report Card on Physical Activity for Children and Youth addresses physical activity surveillance needs by integrating data from numerous sources capturing levels of physical activity and related behaviors (e.g., sedentary behavior, sleep), and facilitators and barriers for physical activity among United States youth. The 2024 Report Card is the 5thand decennial iteration in the series, released October 2024.Methods:A Report Card Working Group was assembled under the auspices of the Physical Activity Alliance and National Physical Activity Plan. Members reviewed the evidence for 11 indicators using data from nationally representative surveys and assigned grades. Data were examined for the overall population and, when possible, by age, sex, race/ethnicity, and disability subgroups. A standardized grading rubric was used to assign a letter grade to each indicator ranging from A to F. Trends in key benchmarks over time were examined since the first report card (2014) or earliest available data.Results:Sufficient data were available to assign grades for 8 of the 11 indicators. The assigned grades ranged from B- to F, with overall physical activity levels earning a D- (Table 1). No indicators improved since 2014. Five indicators – overall physical activity, organized sport participation, active transportation, sedentary behaviors, and school – worsened since 2014.Conclusions:The compiled surveillance report indicates generally poor grades and concerning trends over the recent decade. These findings highlight opportunities to improve physical activity levels and resources for supporting cardiovascular health among United States youth. Policy approaches are needed to combat societal factors that interfere with physical activity. Gaps in data availability, specificity, and quality point to needs for improved surveillance to track impacts. The 2024 Report Card can be a tool for supporting advocacy of regular physical activity at the national and local level.

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Novembre 2024

Abstract 4144542: In-Hospital Outcomes of Open Mitral Valve Repair or Replacement versus Percutaneous Mitral Valve Repair or Replacement in patients with Prior Mediastinal Radiation: Insight from The National Inpatient Database (2015-2020)

Circulation, Volume 150, Issue Suppl_1, Page A4144542-A4144542, November 12, 2024. Background:Radiation associated heart disease has a wide spectrum of manifestations including pericardial disease, coronary artery disease, and valvular heart disease. Mitral valve regurgitation is the second most common valvular dysfunction in patients with prior mediastinal radiation.Research Question:What are the outcomes of percutaneous or transcatheter mitral valve replacement/repair (T-MVR) versus surgical mitral valve replacement/repair (S-MVR) in patients with prior mediastinal radiation.Methods:The National Inpatient Sample (NIS) was analyzed from 2015-2020 to identify patients with mediastinal tumors and prior exposure to radiation therapy undergoing mitral valve repair/replacement. We subclassified the data into hospitalizations for S-MVR and T-MVR. Baseline characteristics were compared between the two groups and multivariate logistic regression was used to analyze hospitalization outcomes.Results:A total of 1725 patients with prior mediastinal radiation were hospitalized for MVR; 1110 (64.3%) patients underwent S-MVR and 615 (35.6%) patients underwent T-MVR. On a multivariable analysis, the odds of MACCE [aOR: 2.21; 95 % CI: (1.87-4.01); p

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Novembre 2024

Abstract 4124065: Clonal Hematopoiesis of Indeterminate Potential (CHIP) in Chronic Coronary Artery Disease: A Report from the ISCHEMIA Trials Biorepository

Circulation, Volume 150, Issue Suppl_1, Page A4124065-A4124065, November 12, 2024. Introduction:CHIP is associated with CAD and mortality. The prognostic relevance of CHIP for high-risk patients with confirmed CAD is unknown.Hypothesis:CHIP variants are associated with cardiovascular (CV) events and mortality in high-risk patients with known CAD in the ISCHEMIA Trials Biorepository.Methods:895 ISCHEMIA and ISCHEMIA-CKD (hereafter, ISCHEMIA Trials) participants with moderate-severe ischemia and next-generation sequencing performed for CHIP variant allele fractions of ≥2% (CHIP) and ≥10% (large CHIP) were included. Unadjusted and multivariable adjusted (age, sex, diabetes, eGFR not on HD, HD, and LVEF) associations of CHIP and large CHIP with a) ISCHEMIA Trials initial phase primary endpoint (CV death, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, RCA) and b) ISCHEMIA Trials combined initial and extended follow-up phase (hereafter, Cumulative) endpoint of all-cause death .Results:Median (IQR) age of sequenced participants was 67 (56 – 79) years, 19% were female, 83% white, and 6% Hispanic. Hypertension (84%), diabetes (45%) and obesity (47%) were common, 26% had an eGFR 1 gene. Over 3.1 years of RCT follow-up there were 135 (20%), 32 (16%) and 15 (18%) primary endpoints for no CHIP, CHIP and large CHIP, respectively. Over 6.8 years of EXTEND follow-up, there were 126 (18%), 47 (23%) and 24 (29%) deaths in the no CHIP, CHIP and large CHIP groups, respectively. After multivariable adjustment there was no association between CHIP or large CHIP and CV events or mortality (Figure 1c).Conclusion:Neither CHIP nor large CHIP was associated with adverse outcomes in 895 high-risk individuals with confirmed CAD, despite a high prevalence of these mutations.

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Novembre 2024

Abstract 4139467: Application and Outcomes of Coronary Atherectomy in Patients with Acute Coronary Syndrome: A Report from the Nationwide J-PCI Registry

Circulation, Volume 150, Issue Suppl_1, Page A4139467-A4139467, November 12, 2024. Introduction:Acute coronary syndrome (ACS) has been generally considered a relative contraindication to coronary atherectomy.Aims:The objective of this study was to investigate the temporal trends and hospital variability in the use of coronary atherectomy and its outcomes among patients undergoing percutaneous coronary intervention (PCI) for ACS from a nationwide PCI registry in Japan.Methods:First, we analyzed the temporal trend in the use of rotational atherectomy (RA) and orbital atherectomy (OA) during PCI for ACS patients between 2014 and 2022 (822,237 PCIs from 1,269 hospitals). Next, we assessed the outcomes of the patients who underwent RA for ACS between 2019 and 2022 (7,421 patients across 662 hospitals). The primary outcome was in-hospital mortality after PCI. Patient outcomes associated with hospital PCI volumes and the device policy change on coronary atherectomy in Japan in 2020, which allowed operators to perform coronary atherectomy without on-site surgical backup, were also evaluated.Results:The rate of RA for ACS was low at 2.0% in the overall cohort (16,264/822,237 PCIs); the rate slightly increased from 1.9% in 2014-2019 to 2.1% in 2020-2022 (after the device policy change). The rate of PCI with OA for ACS was also low at 0.8% in 2021-2022 (1,404/185,141 PCIs). Increasing the complexity of baseline characteristics, including advanced age, diabetes, chronic kidney disease, dialysis, peripheral arterial disease, prior coronary artery bypass grafting, ST-segment elevation myocardial infarction, cardiac arrest within 24 h, cardiogenic shock within 24 h, three-vessel disease, and mechanical circulatory support during PCI was significantly associated with increased in-hospital mortality after PCI with RA in ACS patients (P

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Novembre 2024

Abstract 4143176: Association Between Frailty Testing through Gait Speed and Mortality in CRT Patients: Report for a Multidisciplinary CRT Clinic

Circulation, Volume 150, Issue Suppl_1, Page A4143176-A4143176, November 12, 2024. Background:Identifying predictors of mortality in CRT patients remains an active area of investigation.Objective:To establish a relationship between gait speed (GS) and mortality in heart failure patients with CRT.Hypothesis:Patients with slower gait speeds have worse survival rates after CRT implantation.Methods:This retrospective study included 504 patients who underwent CRT implantation at our institution between 2017-2022. All patients were followed up with a multidisciplinary team, including electrophysiology and heart failure physicians about 6 months after CRT implantation, where frailty was assessed. We used GS as a measure of frailty and divided patients into 2 groups: GS: 5% with reduction in LVESV >10%; anybody not meeting this definition was classified as a non-responder. Responder and non-responder rates among GS< 1 m/s and GS >1 m/s were 53.8% vs 66.4%; and 35.1% vs 26.2%, respectively. The median (IQR) GS was 1.15 m/s (0.91-1.37 m/s). 52 (10.3%) patients had a composite outcome within 2 years follow up. Non-parametric univariate analysis revealed that lower GS was significantly associated higher composite outcome rates (median GS 0.8 vs 1.18 m/s; p

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Novembre 2024

Abstract 4145166: Early Report of Heart Failure Readmissions and Guideline-Directed Medical Therapy Use in A Virtual Hospital at Home Model of Care

Circulation, Volume 150, Issue Suppl_1, Page A4145166-A4145166, November 12, 2024. Background:Interest in hospital at home (HaH) has grown, driven by recognition of potential to ameliorate capacity constraints and lower total costs of care associated with traditional “brick-and-mortar” (BaM) hospitalizations. Heart failure (HF) patients often require decongestion with intravenous diuretics and titration of multiple guideline-directed medical therapies (GDMT). We aimed to demonstrate that a virtual HaH model represents a safe and feasible option for patients with acute heart failure (AHF).Methods:This was a retrospective cohort analysis of patients admitted to the Cleveland Clinic HaH after clinical and social screening and enrollment in HaH from 4/2023 to 1/2024 (Fig 1). Patients with AHF were identified through pre-specified ICD-10 codes. We performed chart abstraction to evaluate demographic characteristics, admissions, vitals, lab values, 30-day readmissions/death, use of individual HF medications, and tabulated GDMT scores among this cohort of HaH patients. Statistical analysis involved parametric and non-parametric paired analysis at admission and discharge.Results:81% of patients (78/96) with AHF that were offered HaH as an alternative to BaM hospitalization opted to enroll in HaH. Patient were of median age 81 years [IQR 16], median LVEF 51.0% [IQR 20], and median admission NTproBNP 3518 [IQR 4619]; 66% of patients were male. Among the cohort, 7 (8.9%) patients were readmitted 30 days from discharge, and there were no deaths in the cohort at 30 month follow-up. By paired analysis, there was a net increase in GDMT score. Systolic blood pressure, diastolic blood pressure, and weight significantly trended down after admission to the HaH (Fig 2).Conclusions:In an early cohort of patients, HaH was selected by most eligible patients over BaM hospital care. There were low rates of readmission and net improvement in GDMT use. HaH can be safe and effective for selected HF patients, though further prospective research is needed.

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Novembre 2024

Abstract 4145402: The Role of Extracorporeal Membrane Oxygenation in Advanced Peripartum Cardiomyopathy Requiring Heart Transplant: A Case Report

Circulation, Volume 150, Issue Suppl_1, Page A4145402-A4145402, November 12, 2024. INTRODUCTION:Peripartum cardiomyopathy (PPCM) is a form of systolic heart failure, which occurs late in pregnancy or within the first 5 months postpartum and it is the most common cause of death related to heart failure in pregnant women. To establish the diagnosis, other causes of heart failure must be ruled out and a left ventricular ejection fraction (LVEF)

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Novembre 2024

Abstract 4141052: Rare Combo: An Unusual Case of a 54-year-old Filipino with Coronary Artery Fistula from Left Anterior Descending Artery to Main Pulmonary Artery and Acute Cerebellar Infarct: A Cardio – Cerebral Infarction Syndrome – Case Report

Circulation, Volume 150, Issue Suppl_1, Page A4141052-A4141052, November 12, 2024. Introduction:Cardio-cerebral infarction, a rare clinical presentation involving simultaneous acute ischemic stroke and acute myocardial infarction, poses significant therapeutic challenges. The incidence of this dual infarction is currently unknown due to its rarity. Delaying intervention for one condition to address the other can lead to permanent morbidity, disability, or even death. Coronary artery fistulas are uncommon with estimated incidence of 0.3%. Among these, a fistula between the left anterior descending artery and the pulmonary artery is the rarest variant, comprising about 17% of all coronary artery fistula cases.Case:A 54-year-old male, with a known history of atrial fibrillation and hypertension, presented to our emergency department with non-rotatory dizziness. Physical examination was unremarkable, but neurological examination revealed medial rectus palsy and left facial asymmetry. A cranial MRI indicated a hyperacute infarction in the left cerebellum. Laboratory tests showed markedly elevated troponin I levels ( >50 ng/ml) and atrial fibrillation, along with inferior wall ST elevation on the electrocardiogram. Due to the high risk of hemorrhagic conversion, the loading of antiplatelets was deferred. Instead, the patient was treated with Aspirin 80 mg once daily, Clopidogrel 75 mg once daily, and Enoxaparin 0.4 ml subcutaneously once daily. A 2D echocardiogram revealed an ejection fraction of 43%, hypokinesia of the anterior and intraventricular septum from base to apex, and severe mitral stenosis. Cardiac catheterization identified a coronary artery fistula from the left anterior descending coronary artery to the main pulmonary artery. Treatment for acute coronary syndrome and acute cerebellar infarct continued. An open-heart surgery was considered. However, during his hospital stay, the patient experienced hemorrhagic conversion and altered sensorium. His condition further deteriorated, necessitating a tracheostomy and long-term care.Conclusion:Cardio-cerebral infarction is an extremely rare and poorly studied syndrome that presents significant treatment challenges and carries a grave prognosis if not addressed immediately. The medical conundrum of deciding which condition to treat first underscores the need for further research. Both interventional cardiologists and interventional neuroradiologists play crucial roles in the effective management of this emergency condition.

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Novembre 2024