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Sex-Differences in Long-term Mortality in Patients with ST-Segment elevation myocardial infarction with and without obstructive coronary arteries

Abstract Background Myocardial infarction with non-obstructive coronary arteries (MINOCA) is a complex and understudied syndrome that disproportionally affects females. Studies to date evaluating sex-differences in ST-segment elevation MINOCA (STE-MINOCA) are limited; therefore, it remains uncertain whether the sex disparities observed in STEMI due to obstructive coronary arteries (STEMI-Obstruction) are also present in STE-MINOCA patients. Objectives Compare clinical characteristics and long-term mortality risk in male versus female patients presenting with STE-MINOCA and STEMI-Obstruction. Methods A multicenter registry-based cohort study enrolled consecutive STEMI patients at three regional, tertiary STEMI centers from 2003 to 2020. STE-MINOCA inluded patients with (1) coronary stenosis less than 60% as determined by coronary angiography, (2) evidence of ischemia with elevated troponin, and (3) no alternative diagnosis. Survival times between males and females with each diagnosis (STE-MINOCA & STEMI-Obstruction) were estimated using the Kaplan Meier method and compared using log-rank tests. The risk of 5-year mortality in patients surviving to discharge was estimated from a Cox regression model with the interaction term for sex and diagnosis STE-MINOCA or STEMI-Obstruction) and adjusted for age, hypertension, diabetes, dyslipidemia, year of event and clustered by the study site. Results Out of 8,566 STEMI patients, 420 (4.9%) had STE-MINOCA of whom 52.9% were female and 8146 (95.1%) had STEMI-Obstruction of whom 29.3% were female. Median follow-up was 7.1 years. Females had significantly higher 5-year mortality risk compared to male counterparts in both STE-MINOCA [HR 2.37 (1.37-4.11, p=0.002)] and STEMI-Obstruction [HR 1.81 (1.59-2.07, p<0.001)] (Figure). After adjusting for confounding variables, the sex difference in mortality risk were not significant: HR 1.04 (0.60-1.81, p=0.89) in STE-MINOCA and HR 1.06 (0.92-1.21, p=0.45) in STEMI-Obstruction. Conclusions In this first study of consecutive STEMI patients examining sex differences by obstructive and non-obstructive mechanism, we report higher 5-year mortality risk in females presenting with STE-MINOCA and STEMI-Obstruction that was attenuated when accounting for age and baseline comorbidities. This study highlights the importance of standardized STEMI protocols to eliminate sex disparities. Abbreviations and Acronyms: Myocardial infarction with non-obstructive coronary arteries (MINOCA), ST-segment elevation MINOCA (STE-MINOCA) STEMI due to obstructive coronary arteries (STEMI-Obstruction)Figure

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Wavelet transform analysis reveals differences between patients with impaired left ventricular systolic function and healthy individuals

AbstractBackgroundDespite continuous progress in medical treatment, heart failure (HF) is the leading cause of hospitalizations with a high all-cause mortality in patients. Patients with a left ventricular ejection fraction (LVEF) below 50% are characterized by the highest risk of cardiovascular complications. The objective of this study was to examine how LVEF below 50% and aging impact cardiovascular physiology.MethodsSixteen males with physician diagnosed coronary artery disease and LVEF = 42 ± 6% (age 62 ± 6 years, BMI 29.1 ± 3.8kg/m2) and 10 healthy controls (9 male and 1 female, age 28.5 ± 9.1 years, BMI = 24.1 ± 1.2kg/m2) were recruited in our study. Finger photoplethysmography for blood pressure (BP) and electrocardiogram (ECG) were recorded while participants rested in a supine position. Wavelet transformations were used to analyze the amplitudes, phase coherence and phase difference of BP and ECG. The frequency intervals were separated as follows: I (0.6-2Hz), II (0.145– 0.6Hz), III (0.052–0.145Hz), and IV (0.021–0.052Hz).ResultsHF patients showed a decrease (p<0.05) in BP wavelet amplitude intervals III and IV in comparison to controls, and interval I for ECG. A decrease in phase coherence (p<0.01) at interval I is also found in HF patients compared to controls.ConclusionsA decrease in smooth muscle cell activity and smooth muscle autonomic innervation (intervals III and IV) contributions to BP, along with a decrease in cardiac activity as shown by the wavelet amplitude in ECG, suggests altered BP and ECG function in aging HF patients. Furthermore, a decrease in the cardiac interval represents an impairment in the BP and ECG relationship in HF patients. The wavelet transform has the potential to expand our understanding of LVEF and improve diagnostic procedures and patient prognosis.

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Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial.

Our research consortium is preparing for a prospective multicenter trial evaluating the impact of teleneonatology on the health outcomes of at-risk neonates born in community hospitals. We completed a 6-month pilot study to determine the feasibility of the trial protocol. Four neonatal intensive care units ("hubs") and four community hospitals ("spokes") participated in the pilot-forming four hub-spoke dyads. Two hub-spoke dyads implemented synchronous, audio-video telemedicine consultations with a neonatologist ("teleneonatology"). The primary outcome was a composite feasibility score that included one point for each of the following: site retention, on-time screening log completion, no eligibility errors, on-time data submission, and sponsor site-dyad meeting attendance (score range 0-5). For the 20 hub-spoke dyad months, the mean (range) composite feasibility score was 4.6 (4, 5). All sites were retained during the pilot. Ninety percent (18/20) of screening logs were completed on time. The eligibility error rate was 0.2% (3/1809). On-time data submission rate was 88.4% (84/95 case report forms). Eighty-five percent (17/20) of sponsor site-dyad meetings were attended by both hub and spoke site staff. A multicenter teleneonatology clinical effectiveness trial is feasible. Learnings from the pilot study may improve the likelihood of success of the main trial. A prospective, multicenter clinical trial evaluating the impact of teleneonatology on the early health outcomes of at-risk neonates born in community hospitals is feasible. A multidimensional composite feasibility score, which includes processes and procedures fundamental to completing a clinical trial, is useful for quantitatively measuring pilot study success. A pilot study allows the investigative team to test trial methods and materials to identify what works well or requires modification. Learnings from a pilot study may improve the quality and efficiency of the main effectiveness trial.

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Refined Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension: Initial Results of U.S. Regional Program

BackgroundBalloon pulmonary angioplasty (BPA) is rapidly evolving therapeutic option for patients with nonsurgical chronic thromboembolic pulmonary hypertension (CTEPH). There are few U.S. studies that have reported on the outcomes of this novel therapeutic option. ObjectivesThe authors sought to evaluate the efficacy and safety of refined BPA in the treatment of patients with CTEPH. MethodsThis is a retrospective study of CTEPH patients that underwent BPA. The primary efficacy endpoint was the change in pulmonary vascular resistance after BPA as compared to baseline and the primary safety endpoint was the rate of hemoptysis within 24 hours. Secondary endpoints included death, World Health Organization functional class, and 6-minute walk distance. Logistic regression was used to evaluate factors associated with a hemodynamic and functional response. ResultsA total of 211 BPA sessions were performed on 77 patients (average 2.7 ± 1.7 sessions/patient). After BPA the mean pulmonary vascular resistance improved by 26% (6.5 ± 3.4 WU to 4.8 ± 2.9 WU, P < 0.001). The mean 6-minute walk distance improved by 71.7 m (P < 0.001), and WHO functional class improved by 1 functional class (P < 0.001). There was one death related to reperfusion lung injury. Ten sessions (4.7%) were complicated by hemoptysis. Independent factors associated with improved functional and hemodynamic response included preprocedural use of riociguat, reduce baseline PA compliance, and >3 BPA sessions/patient. ConclusionsThis single center study from the United States showed that BPA with refined techniques in patients with CTEPH was relatively safe and was associated with significant improvements in pulmonary hemodynamics and functional capacity.

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Characteristics and Long-term Mortality in Patients with ST-Segment Elevation Myocardial Infarction with Non-Obstructive Coronary Arteries (STE-MINOCA): A High Risk Cohort.

The prognosis of ST-segment elevation myocardial infarction with non-obstructive coronaries (STE-MINOCA) is largely unknown. The objective of this study is to evaluate the prevalence, characteristics, and 5-year mortality of patients with STE-MINOCA compared to STEMI with coronary artery obstruction (STEMI-Obstruction) using a multicenter cohort of consecutive STEMI patients at 3 regional Midwest STEMI programs from 2003 to 2020. STE-MINOCA was defined based on (1) coronary stenosis < 60% by visual estimation, (2) ischemia with elevated troponin, and (3) no alternative diagnosis. STE-MINOCA was further classified based on American Heart Association (AHA) definition as AHA STE-MINOCA and AHA STE-MINOCA Mimicker. 8,566 STEMI patients, including 420 (4.9%) STE-MINOCA (26.9% AHA STE-MINOCA and 73.1% AHA STE-MINOCA Mimicker) were followed for a median of 7.1 years. Compared to STEMI-Obstruction, STE-MINOCA were younger, more often female, had fewer cardiovascular risk factors, and were less likely to be discharged on cardiac medications. At five years, mortality was higher in STE-MINOCA compared with STEMI-Obstruction (18% vs. 15%, p=0.033). In propensity score-matched analysis, STE-MINOCA had a 1.4-fold (95% CI: 1.04-1.89, p=0.028) higher risk of 5-year all-cause mortality compared with STEMI-Obstruction. Furthermore, 5-year mortality risk was significantly higher in AHA STE-MINOCA Mimicker (19% vs. 15%, p=0.043) but similar in AHA STE-MINOCA (17% vs. 15%, p=0.42) compared with STEMI-Obstruction. In this large multicenter STEMI cohort, nearly 5% of patients presented with STE-MINOCA. At five years, mortality approached 20% among patients with STE-MINOCA. Despite the lower risk profile, STE-MINOCA patients were at 40% higher risk of 5-year all-cause mortality compared with STEMI-Obstruction. Additionally, 5-year all-cause mortality risk was higher in AHA STE-MINOCA Mimicker but similar in AHA STE-MINOCA compared to STEMI-Obstruction.

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Abstract 11052: Implanting Cardiovascular Electronic Devices With a Biologic Tissue Envelope Improves Healing and Facilitates Reoperative Procedures

Introduction: Fibrous encapsulation of implanted cardiovascular implantable electronic devices (CIED) may create a hostile environment during device reoperation. An acellular biologic extracellular tissue CIED envelope (CanGaroo®, Aziyo Biologics) may attenuate host foreign body response to the implant, decrease fibrosis and enable adaptive vascularized healing to facilitate reoperation &amp; decrease complications. Hypothesis: CIED implant site findings at reoperation differ in patients who previously received a biologic envelope (BIO) vs no envelope (NO-BIO) at time of device implant. Methods: Patients undergoing reoperative CIED procedures (9 BIO, 12 NO-BIO) were assessed (medical profiles, procedural notes, scaled scoring of intra-operative assessments &amp; tissue biopsy histology of the implant pocket). Results: There were no significant cohort differences in mean age, gender or implant location. Median capsular lead adhesion classification (semi-qualitative scale) was significantly lower (less severe) for BIO implants (p=0.02) [Fig. 1, double arrows]. Physicians scored BIO reoperations (10-pt scale) as 39% less difficult in generator mobilization (p=0.04), 43% less difficult in lead mobilization (p=0.04) and 45% less overall procedural difficulty (p=0.01). BIO pockets required 63% fewer capsulectomies (p=0.18). Multipoint histologic assessment of fibrotic capsule thickness (16 matrixed measurements, 5 BIO vs 11 NO-BIO with complete datasets) revealed a 39% reduction in BIO implant pockets (p=0.05), with no significant differences between groups in capsule mature collagen density [Fig. 1, single arrows]. Conclusions: When a BIO envelope was used at initial CIED implantation (vs no envelope), we observed significantly less fibrous lead entrapment, easier generator &amp; lead mobilization, and thinner mature fibrotic capsules at reoperation. Biologic tissue envelopes may prevent operative complications and enhance clinical outcomes.

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