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With increasing survivorship following cerebrovascular accidents (CVAs), more patients with a history of CVA are undergoing total shoulder arthroplasty (TSA). The purpose of this study is to determine the impact of prior CVA on the perioperative outcomes following TSA. The Nationwide Readmissions Database was queried from 2010 to 2019 to identify all patients with a history of CVA undergoing TSA. Eight hundred seventeen cases were identified and case matched on a 1:2 ratio for age, sex, obesity status, and year of procedure. Patient demographic characteristics were collected and analyzed for differences between the 2 groups. Data on length of stay, 180-day complications, 180-day readmissions, and 180-day mortality were collected and analyzed for differences between the 2 groups. Eight hundred seventeen cases of patients with a history of CVA were matched with 1634 patients without a history of CVA undergoing TSA. The average age was 71. Fifty six percent of patients were female, and 23% of patients were obese. Patients with CVA had higher incidence of tobacco use (P <.001), deficiency anemia (P <.001), electrolyte disorders (P <.001), paralysis (P <.001), coagulopathy (P <.001), heart valve disorders (P <.001), history of myocardial infarction (P <.001), and higher rates of chronic diseases, such as hypertension (P <.001), diabetes (P <.001), liver disease (P <.001), congestive heart failure (P <.001), renal failure (P <.001), and peripheral vascular disease (P <.001). Patients with a history of CVA had higher rates of complications, readmissions, and revisions within 180 days (P <.001). One hundred eighty–day mortality was similar between the 2 groups. The average length of stay was 3.2 days in patients with a history of CVA compared to 1.4 days in those without a history of CVA (P <.001). Patients with a history of CVA have a higher rate of medical comorbidities than those without. These patients have higher rates of complications within 180 days of procedure, 180-day readmissions, and 180-day revisions. One hundred eighty–day mortality was similar between the 2 groups. Surgeons should take care to ensure thorough preoperative optimization and risk discussions to try and minimize postoperative adverse outcomes. [ABSTRACT FROM AUTHOR]

The purpose of this systematic review was to characterize the association between tobacco use and postoperative outcomes, complications, and revision rates following shoulder arthroplasty through a systematic review of the literature. The PubMed/MEDLINE and Embase databases were queried for studies published between January 1, 1985, and April 18, 2023, comparing outcomes following both anatomic and reverse total shoulder arthroplasty (TSA) between tobacco users and nontobacco users. Studies with a level of evidence IV or greater were included, while case reports, systematic reviews, basic science studies, and studies including revision arthroplasty were excluded. American Shoulder and Elbow Surgeons scores, simple shoulder test scores, visual analog scale for pain, complications, readmissions, and reoperations were reported. A total of 20 unique studies including 338,117 shoulder arthroplasties (38,225 [11.3%] performed on tobacco users) were included in this review. Patient-reported outcome measures, including American Shoulder and Elbow Surgeons, simple shoulder test, and visual analog scale, were overall superior in nontobacco users compared to tobacco users. Similarly, tobacco users had lower patient acceptable symptomatic state achievement, worse Single Assessment Numeric Evaluation scores (odds ratio 0.647; 95% confidence interval, 0.324-1.293; P =.0221), and worse constant scores (odds ratio, 0.478; 95% confidence interval, 0.251-0.909; P =.027). Tobacco users demonstrated a higher rate of complications in four of the eight included studies. Two included studies found higher rates of readmission in tobacco users (15.3% vs. 13.6%, P =.007 and 7.8% vs. 7.1%, P =.001), though six included studies found no significant difference in readmissions. Nine of 11 studies that included reoperation as a variable found higher rates of reoperation in tobacco users, with three reaching statistical significance (P <.05). Tobacco users experienced higher rates of gastrointestinal complications (0.07% vs. 0.01%, P =.021), acute renal failure (2.5% vs. 1.9%, P =.005), acute respiratory distress (1.3% vs. 0.9%, P =.002), need for ventilator assistance (1.2% vs. 0.7%, P <.001), instability of the prosthesis (P <.001), pneumonia (P <.001), sepsis (P =.001), and myocardial infarction (P <.001). Smokers also demonstrated increased postoperative opioid use (2643 mg oral morphine equivalents) compared to nonsmokers (2121 mg) and former smokers (2015 mg; P =.04). Tobacco use is associated with inferior outcomes after TSA, including lower patient-reported outcome measures, increased complications, and higher reoperation rates. Further high-level, prospective studies with long-term follow-up are required to further elucidate the impact of tobacco use on long-term postoperative outcomes following TSA. [ABSTRACT FROM AUTHOR]

The safety and efficacy of coronary orbital atherectomy (OA) for treatment of ostial lesions are not yet fully established. We sought to evaluate (OA) treatment of severely calcified ostial and non-ostial lesions. A retrospective analysis of subjects treated with OA for severely calcified ostial and non-ostial lesions, at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB) from January 2014 to September 2020, was completed. Study baseline characteristics, lesion and vessel characteristics, procedural outcomes, and in-hospital major adverse cardiovascular events (MACE) were analyzed and compared. A total of 609 patients that underwent PCI with OA were identified. The majority of patients (81.9 %) had non-ostial lesions, while 16.6 % had ostial lesions (of which 2.8 % classified as aorto-ostial) and 1.5 % had unknown lesion anatomy. The mean age of the overall cohort was 74.0 ± 9.3 years, and 63.5 % were male. All patients received drug-eluting stent (DES) placement, and the overall freedom from MACE was 98.5 %, with no significant difference observed between the ostial and non-ostial groups. The freedom from cardiac death and MI was also similar between the two groups. There were low rates of bleeding complications and severe angiographic complications, and no persistent slow flow/no reflow was reported. This study demonstrated no significant differences in in-hospital MACE outcomes between patients with ostial versus non-ostial lesions, indicating that OA is a safe and effective treatment option for both lesion types, including those classified as aorto-ostial. • There is limited atherectomy data in patients with severely calcified ostial lesions. • All patients had successful drug-eluting stent (DES) placement. • The overall freedom from MACE was 98.5 %, with no significant difference between the ostial and non-ostial groups. • The freedom from cardiac death and MI was also similar between the two groups. • Coronary orbital atherectomy can be used safely and effectively in ostial lesions. [ABSTRACT FROM AUTHOR]

There are concerns about the potential effect of social distancing used to control COVID-19 on the incidence of cardiovascular diseases (CVD). Retrospective cohort study. We examined the association between lockdown and CVD incidence in a Zero-COVID country, New Caledonia. Inclusion criteria were defined by a positive troponin sample during hospitalization. The study period lasted for 2 months, starting March 20, 2020 (strict lockdown: first month; loose lockdown: second month) compared with the same period of the three previous years to calculate incidence ratio (IR). Demographic characteristics and main CVD diagnoses were collected. The primary endpoint was the change in incidence of hospital admission with CVD during lockdown compared with the historical counterpart. The secondary endpoint included influence of strict lockdown, change in incidence of the primary endpoint by disease, and outcome incidences (intubation or death) analyzed with inverse probability weighting method. A total of 1215 patients were included: 264 in 2020 vs 317 (average of the historical period). CVD hospitalizations were reduced during strict lockdown (IR 0.71 [0.58–0.88]), but not during loose lockdown (IR 0.94 [0.78–1.12]). The incidence of acute coronary syndromes was similar in both periods. The incidence of acute decompensated heart failure was reduced during strict lockdown (IR 0.42 [0.24–0.73]), followed by a rebound (IR 1.42 [1–1.98]). There was no association between lockdown and short-term outcomes. Our study showed that lockdown was associated with a striking reduction in CVD hospitalizations, independently from viral spread, and a rebound of acute decompensated heart failure hospitalizations during looser lockdown. [ABSTRACT FROM AUTHOR]

Background: In the multicenter, randomized, sham-controlled FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial, quantitative flow ratio (QFR)-based lesion selection improved 1-year clinical outcomes compared with conventional angiographic guidance for percutaneous coronary intervention (PCI).Objectives: The purpose of this study was to determine whether the benefits of QFR guidance persist at 2 years, particularly for patients in whom QFR changed the revascularization strategy.Methods: Eligible patients were randomized to a QFR-guided strategy (PCI performed only if QFR ≤0.80) or a standard angiography-guided strategy. Major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization occurring within 2 years were analyzed in the intention-to-treat population.Results: Among 3,825 randomized participants, 2-year MACE occurred in 161 of 1,913 (8.5%) patients in the QFR-guided group and in 237 of 1,912 (12.5%) patients in the angiography-guided group (HR: 0.66; 95% CI: 0.54-0.81; P < 0.0001), driven by fewer MIs (4.0% vs 6.8%; HR: 0.58; 95% CI: 0.44-0.77; P = 0.0002) and ischemia-driven revascularizations (4.2% vs 5.8%; HR: 0.71; 95% CI: 0.53-0.95; P = 0.02) in the QFR-guided group. Landmark analysis showed consistent results within the first year and between 1-2 years (Pint = 0.99). Although the 2-year MACE rate was lower in the QFR-guided group in both patients with and without revascularization strategy changes, the extent of outcome improvement was greater (Pint = 0.009) among those patients in whom the preplanned PCI strategy was modified by QFR.Conclusions: QFR-guided lesion selection improved 2-year clinical outcomes compared with standard angiography guidance. The benefits were most pronounced among patients in whom QFR assessment altered the planned revascularization strategy. (FAVOR III China Study [The Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease] NCT03656848). [ABSTRACT FROM AUTHOR]

Background: Early inflammation following acute ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI) affects myocardial infarct (MI) size and left ventricular remodeling. The mammalian target of rapamycin (mTOR) is involved in the enhanced inflammatory response and its inhibition has exerted beneficial effects on MI size in preclinical models of acute MI.Objectives: The CLEVER-ACS (Controlled Level Everolimus in Acute Coronary Syndromes) trial evaluated the effects of targeting inflammation by mTOR inhibition in patients with STEMI undergoing PCI.Methods: CLEVER-ACS was a randomized, multicenter, international, double-blind, placebo-controlled trial. A total of 150 patients with STEMI undergoing PCI were randomly assigned to oral everolimus (days 1-3: 7.5 mg daily; days 4-5: 5.0 mg daily) or placebo for 5 days. The primary endpoint was the change in MI size. The secondary endpoint was the change in microvascular obstruction (MVO) from baseline (12 hours to 5 days after PCI) to 30 days as assessed by cardiac magnetic resonance imaging.Results: The changes in MI size from baseline to 30 days, the primary endpoint, were -14.2 g (95% CI: -17.4 to -11.1 g) and -12.3 g (95% CI: -16.0 to -8.7 g) in the everolimus and placebo groups (P = 0.99). Corresponding changes in MVO were -4.8 g (95% CI: -6.7 to -2.9 g) and -6.3 g (95% CI: -8.7 to -4.0 g) in the everolimus and placebo groups (P = 0.14). Adverse events did not differ between the study groups.Conclusions: Among STEMI patients undergoing PCI, early mTOR inhibition with everolimus did not reduce MI size or MVO at 30 days. (CLEVER-ACS [Controlled Level Everolimus in Acute Coronary Syndromes; NCT01529554). [ABSTRACT FROM AUTHOR]

Ferroptosis, a recently identified non-apoptotic form of cell death reliant on iron, is distinguished by an escalation in lipid reactive oxygen species (ROS) that are iron-dependent. This phenomenon has a strong correlation with irregularities in iron metabolism and lipid peroxidation. Salvia miltiorrhiza Bunge (DS), a medicinal herb frequently utilized in China, is highly esteemed for its therapeutic effectiveness in enhancing blood circulation and ameliorating blood stasis, particularly during the treatment of cardiovascular diseases (CVDs). Numerous pharmacological studies have identified that DS manifests antioxidative stress effects as well as inhibits lipid peroxidation. However, ambiguity persists regarding the potential of DS to impede ferroptosis in cardiomyocytes and subsequently improve myocardial damage post-myocardial infarction (MI). The present work focused on investigating whether DS could be used to prevent the ferroptosis of cardiomyocytes and improve post-MI myocardial damage. In vivo experiments: Through ligation of the left anterior descending coronary artery, we constructed both a wild-type (WT) and NF-E2 p45-related factor 2 knockout (Nrf2−/−) mouse model of MI. Effects of DS and ferrostatin-1 (Fer-1) on post-MI cardiomyocyte ferroptosis were examined through detecting ferroptosis and myocardial damage-related indicators as well as Nrf2 signaling-associated protein levels. In vitro experiments: Erastin was used for stimulating H9C2 cardiomyocytes to construct an in vitro ferroptosis cardiomyocyte model. Effects of DS and Fer-1 on cardiomyocyte ferroptosis were determined based on ferroptosis-related indicators and Nrf2 signaling-associated protein levels. Additionally, inhibitor and activator of Nrf2 were used for confirming the impact of Nrf2 signaling on DS's effect on cardiomyocyte ferroptosis. In vivo : In comparison to the model group, DS suppressed ferroptosis in cardiomyocytes post-MI and ameliorated myocardial damage by inducing Nrf2 signaling-related proteins (Nrf2, xCT, GPX4), diminishing tissue ferrous iron and malondialdehyde (MDA) content. Additionally, it enhanced glutathione (GSH) levels and total superoxide dismutase (SOD) activity, effects that are aligned with those of Fer-1. Moreover, the effect of DS on alleviating cardiomyocyte ferroptosis after MI could be partly inhibited through Nrf2 knockdown. In vitro : Compared with the erastin group, DS inhibited cardiomyocyte ferroptosis by promoting the expression of Nrf2 signaling-related proteins, reducing ferrous iron, ROS, and MDA levels, but increasing GSH content and SOD activity, consistent with the effect of Fer-1. Additionally, Nrf2 inhibition increased erastin-mediated ferroptosis of cardiomyocytes through decreasing Nrf2 signaling-related protein expressions. Co-treatment with DS and Nrf2 activator failed to further enhance the anti-ferroptosis effect of DS. MI is accompanied by cardiomyocyte ferroptosis, whose underlying mechanism is probably associated with Nrf2 signaling inhibition. DS possibly suppresses ferroptosis of cardiomyocytes and improves myocardial damage after MI through activating Nrf2 signaling. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Spontaneous coronary artery dissection (SCAD) is an important cause of myocardial infarction (MI) in young to middle-aged women.Objectives: We aim to define the long-term natural history of SCAD.Methods: We performed a multicenter, prospective, observational study of patients with nonatherosclerotic SCAD presenting acutely from 22 North American centers. We recorded baseline demographics, in-hospital characteristics, precipitating and predisposing conditions, angiographic features (adjudicated), in-hospital and 3-year major adverse cardiovascular events (MACE). Cox regression multivariable analysis was performed.Results: We prospectively enrolled 750 consecutive patients with SCAD from June 2014 to June 2018. Mean age was 51.7 ± 10.5 years, 88.5% were women (55.0% postmenopausal); 31.3% presented with ST-segment elevation myocardial infarction, and 68.3% with non-ST-segment elevation myocardial infarction. Precipitating emotional stressor was reported in 50.3%, and physical stressor in 28.9%. Predisposing conditions included fibromuscular dysplasia in 42.9% (56.4% in those with complete screening), peripartum state 4.5%, and genetic disorders 1.6%. Most patients were treated conservatively (84.3%); 14.1% underwent percutaneous coronary intervention (PCI), 0.7% coronary artery bypass graft. At 3.0-year median follow-up, mortality was 0.8%, recurrent MI 9.9% (extension of previous SCAD 3.5%, de novo recurrent SCAD 2.4%, iatrogenic dissection 1.9%), with overall MACE 14.0%. Presence of genetic disorders, peripartum SCAD, and extracoronary fibromuscular dysplasia were independent predictors of 3-year MACE. Patients who underwent PCI at index hospitalization had similar postdischarge MACE compared with no PCI. At 3 years, 80.0% remained on aspirin and 73.5% on beta-blockade.Conclusions: Long-term mortality and de novo recurrent SCAD was low in our contemporary large SCAD cohort that included low revascularization rate and high use of beta-blockade and aspirin. Genetic disorders, extracoronary fibromuscular dysplasia, and peripartum SCAD were independent predictors of long-term MACE. [ABSTRACT FROM AUTHOR]

Background: The optimal duration of antiplatelet therapy (APT) after coronary stenting in patients at high bleeding risk (HBR) presenting with an acute coronary syndrome remains unclear.Objectives: The objective of this study was to investigate the safety and efficacy of an abbreviated APT regimen after coronary stenting in an HBR population presenting with acute or recent myocardial infarction.Methods: In the MASTER DAPT trial, 4,579 patients at HBR were randomized after 1 month of dual APT (DAPT) to abbreviated (DAPT stopped and 11 months single APT or 5 months in patients with oral anticoagulants) or nonabbreviated APT (DAPT for minimum 3 months) strategies. Randomization was stratified by acute or recent myocardial infarction at index procedure. Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes events (NACE); major adverse cardiac and cerebral events (MACCE); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding.Results: NACE and MACCE did not differ with abbreviated vs nonabbreviated APT regimens in patients with an acute or recent myocardial infarction (n = 1,780; HR: 0.83; 95% CI: 0.61-1.12 and HR: 0.86; 95% CI: 0.62-1.19, respectively) or without an acute or recent myocardial infarction (n = 2,799; HR: 1.03; 95% CI: 0.77-1.38 and HR: 1.13; 95% CI: 0.80-1.59; Pinteraction = 0.31 and 0.25, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding was significantly reduced in patients with or without an acute or recent myocardial infarction (HR: 0.65; 95% CI: 0.46-0.91 and HR: 0.71; 95% CI: 0.54-0.92; Pinteraction = 0.72) with abbreviated APT.Conclusions: A 1-month DAPT strategy in patients with HBR presenting with an acute or recent myocardial infarction results in similar NACE and MACCE rates and reduces bleedings compared with a nonabbreviated DAPT strategy. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020). [ABSTRACT FROM AUTHOR]

Objective: We evaluated the impact of a low intensity web-based and intensive nurse-administered intervention to reduce systolic blood pressure (SBP) among patients with prior MI.Methods: Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE) was a three-arm trial. Patients were randomized to 1) post-MI education-only; 2) nurse-administered telephone program; or 3) web-based interactive tool. The study was conducted 2009-2013.Results: Participants (n = 415) had a mean age of 61 years (standard deviation [SD], 11). Relative to the education-only group, the 12-month differential improvement in SBP was - 3.97 and - 3.27 mmHg for nurse-administered telephone and web-based groups, respectively. Neither were statistically significant. Post hoc exploratory subgroup analyses found participants who received a higher dose (>12 encounters) in the nurse-administered telephone intervention (n = 60; 46%) had an 8.8 mmHg (95% CI, 0.69, 16.89; p = 0.03) differential SBP improvement versus low dose (<11 encounters; n = 71; 54%). For the web-based intervention, those who had higher dose (n = 73; 53%; >1 web encounter) experienced a 2.3 mmHg (95% CI, -10.74, 6.14; p = 0.59) differential SBP improvement versus low dose (n = 65; 47%).Conclusions: The main effects were not statistically significant.Practical Implications: Completing the full dose of the intervention may be essential to experience the intervention effect.Clinical Trial Registration: The unique identifier is NCT00901277 (http://www.Clinicaltrials: gov/ct2/show/NCT00901277?term=NCT00901277&rank=1). [ABSTRACT FROM AUTHOR]

Background: While aortic valve replacement (AVR) is indicated for symptomatic severe aortic stenosis (AS), the appropriate management of asymptomatic severe AS remains unclear. We conducted an updated meta-analysis to compare the outcomes of surgical AVR (SAVR) versus conservative treatment in patients with asymptomatic severe AS.Methods: We searched PubMed, EMBASE, Cochrane, clinicaltrials.gov, and Google Scholar for studies comparing outcomes of SAVR versus conservative treatment in asymptomatic severe AS. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for each individual study. Outcomes included all-cause mortality, cardiovascular and non-cardiovascular mortality, 30-day operative mortality, sudden cardiac death (SCD), heart failure hospitalization (HFH), myocardial infarction (MI), and stroke.Results: A total of 8 studies with 2685 patients were included. The mean age was above 60 years, and the median follow-up duration was 4 years. Compared to conservative treatment, SAVR was associated with significantly lower all-cause mortality (RR 0.39; 95% CI 0.23-0.64) and HFH rates (RR 0.18; 95% CI 0.05-0.71). There were no significant differences in cardiovascular mortality (RR 0.24; 95% CI 0.03-1.67), non-cardiovascular mortality (RR 0.49; 95% CI 0.23-1.03), 30-day operative mortality (RR 0.48; 95% CI 0.10-2.32), SCD (RR 0.37; 95% CI 0.05-2.89), MI (RR 0.48; 95% CI 0.04-5.52), and stroke rates (RR 1.20; 95% CI 0.35-4.11) between the two strategies.Conclusions: In patients with asymptomatic severe AS, SAVR is associated with significantly lower all-cause mortality and HFH compared to conservative treatment. While SAVR is a promising option for asymptomatic severe AS, most studies were observational and nonrandomized; randomized trials are needed to establish a clear benefit. [ABSTRACT FROM AUTHOR]

Introduction: The role of endothelial progenitor cells (EPCs) in atherosclerosis progression and neointimal growth after percutaneous coronary intervention (PCI) remains controversial. The purpose of this study was to perform a systematic review and meta-analysis of studies on EPCs in patients who had PCI.Methods: We searched Pubmed, Embase and Cochrane databases and reviewed cited references up to August 31, 2021. Overall, we selected 9 studies, including 4612 patients.Results: Lower baseline EPC count was associated with a significantly greater occurrence of in-stent restenosis (HR 1.33; 95% CI 0.97-1.82, P = 0.045). As for EPC coating, there was no significant difference in the 1-year occurrence of cardiac death between EPCs-capturing drug-eluting stents (DES) and standard DES (Relative Risk [RR] 1.146; 95% CI 0.666-1.974, P = 0.98), but target lesion revascularization (RR 1.727; 95% CI: 1.199-2.487, P = 0.025), and target vessel failure (RR 1.591; 95% CI 1.213-2.088, P = 0.04) were significantly more common with EPCs-capturing DES than with standard DES.Conclusion: Circulating EPC count might improve risk stratification after PCI, as it is correlated with the occurrence of in-stent restenosis. Currently available EPCs-capturing DES use was associated with an increased risk of 1-year adverse events, mainly driven by an increase in target lesion revascularization and target vessel failure, not cardiac death. [ABSTRACT FROM AUTHOR]

Background: TiNO-coated BAS have demonstrated competitive outcomes compared to drug-eluting stents (DES). These devices allow short antiplatelet regimens and may be a good option for the growing elderly population undergoing percutaneous coronary intervention (PCI).Methods: Multicenter observational trial in routine clinical practice. A propensity-score matched analysis compared a prospective cohort of patients ≥ 75 years undergoing PCI with BAS, with a contemporary and retrospective cohort treated with last-generation DES. The co-primary endpoints of the study were the Target-Lesion-Failure (Cardiac death, non-fatal myocardial infarction, or target lesion revascularization) and Major Adverse Cardiovascular Events (total death, non-fatal myocardial infarction, stroke, or new revascularization) at 1 year.Results: Whole population included 1000 patients, and 326 patients in each group were matched for analysis. No differences in primary endpoints were found: TLF 10.4% vs. 11% (HR 0.96 (Confidence Interval 95%, 0.36-1.7; p = 0.87)) and MACE 16.3% vs. 17.2% (HR 0.98 (Confidence Interval 95%; 0.3-1.5, p = 0.93)). Patients treated with BAS received shorter antiplatelets regimens (dual antiplatelet therapy at 1 year, 25.7% vs. 70.6%, p = 0.0001), and they presented lower incidence of bleeding (3.7% vs. 11.7%, HR 0.3 (IC 95% 0.16-0.6, p = 0.001)).Conclusion: In this real-life registry of patients ≥ 75 years, BAS were similar to the latest-generation DES in terms of efficacy and reduced the duration of the antithrombotic therapy, lowering bleeding events. [ABSTRACT FROM AUTHOR]

Background: While there is increasing support for the efficacy of psychosocial interventions for people with SMI, the real-world effectiveness of such treatments is diminished by lack of motivation for treatment, leading to poor treatment engagement/dropout. We sought to evaluate the efficacy of motivational interviewing (MI) in improving attendance in a full course of cognitive training, examine motivation level as a potential mechanism of action, and examine variables associated with initial engagement in the training.Methods: One hundred fourteen participants with SMI were randomized to MI or sham control interview (CI), both of which were followed by a 4-month active phase during which participants could attend up to 50 unpaid cognitive training sessions.Results: Fidelity to the MI intervention was high, and MI condition was associated with increases in perceived value of training tasks and, to a lesser extent, how enjoyable/interesting they were rated. Twenty-nine percent of the full sample did not attend any training sessions. In ITT analyses, there was no significant between-group impact of MI on treatment attendance, though one emerged when participants who did not attend any sessions were excluded. Treatment attendance was predicted by the level of motivation achieved after the MI/CI intervention. Those who attended at least one training session (regardless of randomization) were more likely to believe they had cognitive impairments, had higher IQ and had less severe general psychiatric symptoms.Conclusions: MI showed some promise and may be a worthwhile addition to more comprehensive, robust efforts to promote initial treatment engagement and subsequent adherence. [ABSTRACT FROM AUTHOR]

Background: Magnesium Reabsorbable Scaffold (MRS), is the newest reabsorbable technology with low thrombogenicity, short scaffolding time and almost complete resorption at 12-months (95%). Preliminary 12-months data in selected patients has shown that safety and efficacy are comparable with second generation Drug Eluting Stent (DES). Magmaris Multicenter registry showed 1-and 2-years clinical outcome on the first patients suitable for MRS enrolled in 4 Italian centers.Methods: We evaluated 12- and 24-months clinical results in "real world" experience with Magnesium Reabosrbable Scaffold in terms of Target Lesion Failure (TLF) and scaffold thrombosis (ST). TLF is the primary endpoint and was defined as composite of cardiac mortality, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). 4P's strategy (Patient/lesion selection, Pre-dilatation, Proper scaffold sizing and Post-dilatation) was strongly recommended. Dual Antiplatelet Therapy (DAPT) has been recommended for 12 months.Results: Data from 207 patients, including initial experience, have been collected. Patients were 83% male, 20% diabetic and Acute Coronary Syndrome (ACS) in 23%. Lesion type were A-B1 in 54% and B2C in 46%. 4P's strategy was respected in 94%. Procedural success was 98% (2% peri-procedural MI). Compliance at 12-months follow up was 97.6%, TLF rate was 5.4% (including 1 case of myocardial infarction with late scaffold thrombosis (ST), all patients were successfully treated with in-scaffold segment DES implantation). At 24-months compliance was 92.8% (192 patients) and TLF was 7.4%. In the period between 13 and 24 months only 4 patients had TLF (including 1 case of myocardial infarction, all patients were successfully treated with in-scaffold segment DES implantation). None of the patients died for a cardiac reason.Conclusion: Our 2-years results confirm safety and efficacy showed at 12-months, reinforcing long-term performance with only 2% rate of TLF increase and no ST after 1 year. [ABSTRACT FROM AUTHOR]

Background/purpose: The COBRA Polyzene F™ NanoCoated Coronary Stent System (PzF coated stent) stent demonstrated favorable clinical outcomes at 9 months but late results have not been reported. We sought to assess the late safety and effectiveness of the PzF coated stent for treatment of de novo coronary artery lesions.Methods: Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a non-randomized, prospective clinical trial and followed for 5 years. The primary endpoint was target vessel failure (TVF, cardiac death, myocardial infarction [MI], or clinically-driven target vessel revascularization [TVR]) at 9 months. Secondary endpoints included major adverse clinical events (MACE, cardiac death, MI, or clinically driven TLR), clinically driven target lesion revascularization (TLR) and definite or probable stent thrombosis during 5-year follow-up. Endpoints at 5 years were analyzed as cumulative incidence accounting for competing risk of death.Results: Of 296 enrolled patients, 290 (98%) were evaluable at 5 years. By 5 years, MACE had occurred in 61 (21.3%), cardiac death in 11 (4.2%), MI in 25 (8.6%), and TLR in 34 (12.0%) subjects. Between follow-up years 1 and 5, a first MACE occurred in 17 (6.2%), including 10 (4.0%) cardiac death, 4 (1.6%) MI, and 7 (2.9%) TLR events. There were no definite or probable stent thromboses.Conclusions: The PzF coated stent demonstrated continued safety and effectiveness through 5 years with low to very low incident rates of MACE, MI, TLR and stent thrombosis between 1 and 5 years after stent placement. [ABSTRACT FROM AUTHOR]

Background: Whether the access site influences the comparative efficacy and safety of ticagrelor and prasugrel in patients with acute coronary syndrome (ACS) undergoing invasive treatment strategy remains unstudied.Methods: This post-hoc analysis included ACS patients undergoing invasive treatment via radial or femoral access and randomized to either ticagrelor or prasugrel in the ISAR-REACT 5 trial. The primary efficacy endpoint was the composite of death, myocardial infarction (MI) or stroke, safety endpoint was BARC 3 to 5 bleeding. Outcomes were assessed out to 12 months after randomization.Results: Out of 4018 patients, 3984 underwent invasive treatment via radial or femoral access. 1479 had coronary angiography via radial access (ticagrelor, N = 748; prasugrel, N = 731) and 2505 via femoral access (ticagrelor, N = 1245; prasugrel, N = 1260). There was no interaction between access route and assignment to either ticagrelor or prasugrel regarding the primary efficacy or safety endpoints (P for interaction≥0.616). In the radial group, the primary efficacy endpoint (7.6% versus 5.8%, HR: 1.32 [0.88-1.97], P = 0.151) and the safety endpoint (4.3% versus 3.0%, HR: 1.36, [0.73-1.31], P = 0.300) were not statistically different in patients receiving either ticagrelor or prasugrel. In the femoral group, the primary efficacy endpoint occurred more frequently in patients assigned to ticagrelor as compared to prasugrel (10.3% versus 7.3%, HR: 1.44 [1.10-1.88], P = 0.006) without significant difference in terms of safety endpoint (6.4% versus 5.8%, HR: 1.14, [0.81-1.60], P = 0.470).Conclusions: In patients with ACS undergoing an invasive treatment strategy, the access route does not influence the comparative efficacy and safety of ticagrelor and prasugrel.Clinical Trial Registration: NCT01944800. [ABSTRACT FROM AUTHOR]

Background: Several studies have pair-wise compared access sites for transcatheter aortic valve replacement (TAVR) but pooled estimate of overall comparative efficacy and safety outcomes are not well known. We sought to compare short- and long-term outcomes following various alternative access routes for TAVR.Methods: Thirty-four studies with a pooled sample size of 32,756 patients were selected by searching PubMed and Cochrane library databases from inception through 11th June 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data were extracted to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group.Results: Compared with TF, both TAO [RR 1.91, 95% CI (1.46-2.50)] and TA access [RR 2.12, 95% CI (1.84-2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events at 30 days between different accesses. Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28-0.67)] and TC [RR 0.51, 95% CI (0.35-0.73)] access compared to TF. The 1-year mortality was higher in TAO [RR of 1.35, (95% CI, 1.01-1.81)] and TA [RR 1.44, (95% CI, 1.14-1.81)] groups.Conclusion: Non-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with outcomes similar to conventional TF access. Thoracic TAVR access (TAO and TA) translates into increased short and long-term mortality. [ABSTRACT FROM AUTHOR]

Background: The purpose of a bioresorbable scaffold (BRS) is to provide radial support during coronary healing. In this study, coronary artery healing after optical coherence tomography (OCT)- versus angiography-guided magnesium BRS (MBRS) implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) is compared.Methods: 75 patients were randomized 1:1 to OCT- or angiography-guided implantation of a MBRS with protocolled pre- and post-dilation. In the OCT-guided group, prespecified criteria indicating additional intervention were (1) scaffold under-expansion, (2) strut malapposition, (3) edge dissection, and (4) residual stenosis at distal or proximal reference segments. The primary endpoint was OCT-derived healing stage at 6 months.Results: At 6 months, there was no difference in average healing stage between OCT- and angiography-guided intervention (4.6 [interquartile range (IQR): 4.5-4.7] versus 4.5 [IQR: 4.3-4.7]; p = 0.54). The MBRSs were completely resolved in 77.0% [IQR: 68.5-85.5] versus 76.5% [IQR: 67.9-85.5]; (p = 0.97). Minimal lumen area (MLA) was reduced at 6 months in both the OCT- (32.3%; p < 0.01) and the angiography-guided group (21.3%; p < 0.01), however OCT-guided implantation was associated with a greater reduction of total lumen volume (-27.1 ± 32.5 mm3 versus -5.0 ± 32.9 mm3; p < 0.01) and MLA (-2.3 ± 1.6 mm2 vs. -1.4 ± 1.4 mm2; p = 0.02).Conclusions: In NSTEMI patients, OCT-guidance with protocolled pre- and post-dilation of MBRS implantation showed similar healing pattern at 6 months compared to angiography-guidance alone.Clinical Trial Registration: The Coronary Artery Healing Process after Optical Coherence Tomography Guided Percutaneous Coronary Intervention with Magmaris Bioresorbable Scaffold in Patients with Non-ST-Segment-Elevation Myocardial Infarction: (HONEST) trial is registered with ClinicalTrials.gov, NCT03016624. [ABSTRACT FROM AUTHOR]

Aim: To investigate key aspects of the problem of myocardial revascularization failure (MRF) and repeat or secondary myocardial revascularization (SR) in contemporary practice.Methods: The registry of secondary revascularization (REVASEC) is an investigator-initiated, multicenter, prospective registry enhanced with data monitoring and independent event adjudication (ClinicalTrials.govNCT03349385). It includes patients with prior revascularization referred to coronary angiography for suspected MRF with broad inclusion criteria. The main objectives are to describe the characteristics of patients with prior revascularization referred for repeat angiography, to describe and the rate and mechanisms of MRF (stent or graft failure, coronary artery disease progression or residual coronary artery disease); to evaluate the management including medical treatment and SR of these patients; and to assess the prognosis according to the outlined causative mechanisms. The registry has one year follow up for the primary endpoint (Patient-oriented composite endpoint including all-cause death, any myocardial infarction or any new unplanned revascularization according to subsets of MRF), but extended follow-up will be carried out up to 5 years.Conclusion: The REVASEC Registry will provide updated data on the characteristics, patterns of treatment, and 1-year outcomes of patients with MRF and SR in contemporary clinical practice. [ABSTRACT FROM AUTHOR]

Background: Shift work is associated with increased risk of acute myocardial infarction (AMI) and worsened prognosis. However, the mechanisms linking shift work and worsened prognosis in AMI remain unclear.Objectives: This study sought to investigate the impact of shift work on reperfusion injury, a major determinant of clinical outcomes in AMI.Methods: Study patient data were obtained from the database of the EARLY-MYO-CMR (Early Assessment of Myocardial Tissue Characteristics by CMR in STEMI) registry, which was a prospective, multicenter registry of patients with ST-segment elevation myocardial infarction (STEMI) undergoing cardiac magnetic resonance (CMR) imaging after reperfusion therapy. The primary endpoint was CMR-defined post-reperfusion infarct size. A secondary clinical endpoint was the composite of major adverse cardiac events (MACE) during follow-up. Potential mechanisms were explored with the use of preclinical animal AMI models.Results: Of 706 patients enrolled in the EARLY-MYO-CMR registry, 412 patients with STEMI were ultimately included. Shift work was associated with increased CMR-defined infarct size (β = 5.94%; 95% CI: 2.94-8.94; P < 0.0001). During a median follow-up of 5.0 years, shift work was associated with increased risks of MACE (adjusted HR: 1.92; 95% CI: 1.12-3.29; P = 0.017). Consistent with clinical findings, shift work simulation in mice and sheep significantly augmented reperfusion injury in AMI. Mechanism studies identified a novel nuclear receptor subfamily 1 group D member 1/cardiotrophin-like cytokine factor 1 axis in the heart that played a crucial role in mediating the detrimental effects of shift work on myocardial injury.Conclusions: The current study provided novel findings that shift work increases myocardial infarction reperfusion injury. It identified a novel nuclear receptor subfamily 1 group D member 1/cardiotrophin-like cytokine factor 1 axis in the heart that might play a crucial role in mediating this process. (Early Assessment of Myocardial Tissue Characteristics by CMR in STEMI [EARLY-MYO-CMR] registry; NCT03768453). [ABSTRACT FROM AUTHOR]

Background: REDUCE-IT was a double-blind trial that randomized 8,179 statin-treated patients with controlled low-density lipoprotein cholesterol and moderately elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in the primary endpoint, including death from cardiovascular (CV) causes. The specific impact of IPE among patients with prior myocardial infarction (MI) was unknown.Objectives: Our goal was to examine the benefit of IPE on ischemic events among patients with prior MI in REDUCE-IT.Methods: We performed post hoc analyses of patients with prior MI. The primary endpoint was CV death, MI, stroke, coronary revascularization, or hospitalization for unstable angina. The key secondary endpoint was CV death, MI, or stroke.Results: A total of 3,693 patients had a history of prior MI. The primary endpoint was reduced from 26.1% to 20.2% with IPE vs placebo; HR: 0.74 (95% CI: 0.65-0.85; P = 0.00001). The key secondary endpoint was reduced from 18.0% to 13.3%; HR: 0.71 (95% CI: 0.61-0.84; P = 0.00006). There was also a significant 35% relative risk reduction in total ischemic events (P = 0.0000001), a 34% reduction in MI (P = 0.00009), a 30% reduction in CV death (P = 0.01), and a 20% lower rate of all-cause mortality (P = 0.054), although there was a slight increase in atrial fibrillation. Sudden cardiac death and cardiac arrest were also significantly reduced by 40% and 56%, respectively.Conclusions: Patients with a history of prior MI in REDUCE-IT treated with IPE demonstrated large and significant relative and absolute risk reductions in ischemic events, including CV death. (A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. [REDUCE-IT]; NCT01492361). [ABSTRACT FROM AUTHOR]

Objective: To assess whether outcomes following percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease differ between men and women.Background: Current guidelines recommend either PCI or CABG for patients with unprotected LMCA disease and low-to-intermediate anatomical complexity. However, it is unclear whether these guidelines apply to women, who are underrepresented in clinical trials.Methods: An electronic search was performed to identify studies reporting sex-specific outcomes after PCI versus CABG in patients with LMCA disease. Trial level hazard ratios (HRs) and 95% confidence intervals (CIs) were pooled by random-effects modelling.Results: Eight (8) studies met inclusion criteria, comprising 13,066 patients (24.3% women). In both sexes, there was no difference between PCI and CABG with respect to the primary composite endpoint of death, myocardial infarction or stroke (HR in women: 1.03, 95% CI 0.76-1.40; HR in men: 1.04, 95% CI 0.92-1.17). However, both sexes were more likely to require repeat revascularisation after PCI. There was no interaction between sex and treatment effect for the primary composite endpoint nor for the individual outcomes of death, stroke and repeat revascularisation. However, in women the risk of myocardial infarction was higher after PCI compared with CABG (HR 1.84, 95% CI 1.06-3.18), with a trend toward the opposite in men (HR 0.78, 95% CI 0.54-1.13; p-interaction=0.01).Conclusion: Percutaneous coronary intervention and CABG have a comparable risk of the composite outcome of death, stroke or myocardial infarction in patients undergoing revascularisation for LMCA disease, with no significant interaction between sex and treatment effect. [ABSTRACT FROM AUTHOR]

Background: Instantaneous wave-free ratio (iFR) is a coronary physiology index used to assess the severity of coronary artery stenosis to guide revascularization. iFR has previously demonstrated noninferior short-term outcome compared to fractional flow reserve (FFR), but data on longer-term outcome have been lacking.Objectives: The purpose of this study was to investigate the prespecified 5-year follow-up of the primary composite outcome of all-cause mortality, myocardial infarction, and unplanned revascularization of the iFR-SWEDEHEART trial comparing iFR vs FFR in patients with chronic and acute coronary syndromes.Methods: iFR-SWEDEHEART was a multicenter, controlled, open-label, registry-based randomized clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2,037 patients were randomized to undergo revascularization guided by iFR or FFR.Results: No patients were lost to follow-up. At 5 years, the rate of the primary composite endpoint was 21.5% in the iFR group and 19.9% in the FFR group (HR: 1.09; 95% CI: 0.90-1.33). The rates of all-cause death (9.4% vs 7.9%; HR: 1.20; 95% CI: 0.89-1.62), nonfatal myocardial infarction (5.7% vs 5.8%; HR: 1.00; 95% CI: 0.70-1.44), and unplanned revascularization (11.6% vs 11.3%; HR: 1.02; 95% CI: 0.79-1.32) were also not different between the 2 groups. The outcomes were consistent across prespecified subgroups.Conclusions: In patients with chronic or acute coronary syndromes, an iFR-guided revascularization strategy was associated with no difference in the 5-year composite outcome of death, myocardial infarction, and unplanned revascularization compared with an FFR-guided revascularization strategy. (Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome [iFR SWEDEHEART]; NCT02166736). [ABSTRACT FROM AUTHOR]

Background: Examining a variety of diet quality methodologies will inform best practice use of diet quality indices for assessing all-cause and cardiovascular disease (CVD) mortality.Objectives: To examine the association between 3 diet quality indices (Australian Dietary Guideline Index, DGI; Dietary Inflammatory Index, DII; Mediterranean-DASH (Dietary Approaches to Stop Hypertension) Intervention for Neurodegenerative Delay, MIND) and risk of all-cause mortality, CVD mortality, and nonfatal CVD events ≤19 y later.Methods: Data on 10,009 adults (mean age 51.8 y; 52% female) from the Australian Diabetes, Obesity, and Lifestyle study were used. An FFQ was used to calculate DGI, DII, and MIND at baseline. Cox proportional hazard models were used to estimate HRs and 95% CI of all-cause mortality, CVD mortality, and nonfatal CVD events (stroke; myocardial infarction) according to 1 SD increase in diet quality, adjusted for age, sex, education, smoking, physical activity, energy intake, history of stroke or heart attack, and diabetes and hypertension status.Results: Deaths due to all-cause (n = 1955) and CVD (n = 520), and nonfatal CVD events (n = 264) were identified during mean follow-ups of 17.7, 17.4, and 9.6 y, respectively. For all-cause mortality, HRs associated with higher DGI, DII, and MIND were 0.94 (95% CI: 0.89, 0.99), 1.08 (95% CI: 1.02, 1.15), and 0.93 (95% CI: 0.89, 0.98), respectively. For CVD mortality, HRs associated with higher DGI, DII, and MIND were 0.93 (95% CI: 0.85, 0.99), 1.10 (95% CI: 1.00, 1.24), and 0.90 (95% CI: 0.82, 0.98), respectively. There was limited evidence of associations between diet quality and nonfatal CVD events.Conclusions: A better quality diet predicted lower risk of all-cause and CVD mortality in Australian adults, whereas a more inflammatory diet predicted higher mortality risk. These findings highlight the applicability of following Australian dietary guidelines, a Mediterranean-style diet, and a low-inflammatory diet for the reduction of all-cause and CVD mortality risk. [ABSTRACT FROM AUTHOR]

Background: Mature B lymphocytes alter the recovery of cardiac function after acute myocardial infarction (MI) in mice. Follicular B cells and marginal zone B (MZB) cells are spatially distinct mature B-cell populations in the spleen, and they exert specific functional properties. microRNA-21 (miR21)/hypoxia-inducible factor-α (HIF-α)-related pathways have been shown to govern B-cell functions.Objectives: The goal of this study was to unravel the distinct role of MZB cells and that of endogenous activation of miR21/HIF-α signaling in MZB cells during post-ischemic injury.Methods: Acute MI was induced in mice by permanent ligation of the left anterior descending coronary artery. Cardiac function and remodeling were assessed by using echocardiography and immunohistochemistry. To determine the specific role of MZB cells, the study used mice with B-cell lineage-specific conditional deletion of Notch signaling, which leads to selection deficiency of MZB cells. To evaluate the role of the HIF-1α isoform, mice were generated with MZB-cell lineage-specific conditional deletion of Hif1a.Results: Acute MI prompted an miR21-dependent increase in HIF-1α, particularly in splenic MZB cells. MZB cell deficiency and MZB cell-specific deletion of miR21 or Hif1a improved cardiac function after acute MI. miR21/HIF-1α signaling in MZB cells was required for Toll-like receptor dependent expression of the monocyte chemoattractant protein CCL7, leading to increased mobilization of inflammatory monocytes to the ischemic myocardium and to adverse post-ischemic cardiac remodeling.Conclusions: This work reveals a novel function for the miR21/HIF-1α pathway in splenic MZB cells with potential major implications for the modulation of cardiac function after acute MI. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to assess the cost-effectiveness profile of adherence to recommendations for the community management of patients discharged with a diagnosis of acute coronary syndrome (ACS).Methods: The cohort of 50 282 residents in the Lombardy Region (Italy) who were discharged with a diagnosis of ACS during 2011 to 2015 was followed up until 2018. Adherence to selected recommendations including drug therapies (DTs), outpatient controls, and rehabilitation, experienced during the first year after index discharge, was considered. Adherent and nonadherent cohort members were matched on high-dimensional propensity scores. Composite clinical outcomes (cardiovascular hospital admissions and all-cause mortality) and healthcare costs were assessed for a time horizon of 5 years. Cost-effectiveness profile of adherence to recommendations was measured through the incremental cost-effectiveness ratio, that is, the incremental cost for 1 day free from the composite clinical outcome.Results: Adherence to DTs, outpatient controls, and rehabilitation, respectively, regarded 39%, 81%, and 3% of cohort members. Compared with nonadherent patients, those adherent to DTs, outpatient controls, and rehabilitation had (1) a delay in the occurrence of the composite clinical outcome of 50, 43, and 73 days, respectively, and (2) lower (on average, €199 per year for DTs) and higher costs (€292 and €1024 for outpatient controls and rehabilitation). Cost-effectiveness profiles were better for patients with myocardial infarction than those with angina and for patients with more severe clinical complexity than those with milder conditions.Conclusions: Health-related and economic benefits are expected from improving adherence to international guidelines recommendations concerning outpatient treatments and monitoring of patients with ACS. [ABSTRACT FROM AUTHOR]

Objectives: Use of Motivational Interviewing (MI) in education may improve medication-overuse headache (MOH) patients' ability to cope with pain. In a randomised controlled trial, we evaluated the effect of education focusing on behavioural change among MOH patients.Methods: Ninety-eight MOH patients were randomized (1:1) to standard treatment and 12-weeks of MI-based education versus standard treatment alone after detoxification. Outcome of interest was changes in coping strategies measured by the Coping Strategy Questionnaire at four- and nine months.Results: The educational program improved patients' perceived efficacy in the use of their coping strategies to control pain, both at four-and nine months follow-up (mean±SE): ∆:0.84 ± 0.35, 95% CI:0.16;1.52, p = 0.02 and: ∆: 0.90 ± 0.39, 95% CI:0.14;1.66, p = 0.02, respectively. No between-group differences were detected in the other coping subscales. Within the intervention group, the coping strategy subscales Catastrophizing, and Reinterpretation of pain sensation were significantly improved at nine months follow-up (p = 0.003 vs. p = 0.012, respectively). No changes were found in the control group.Conclusion: MI-based education focused on behavioural changes improved MOH patients' perceived efficacy in the use of their coping strategies to control pain.Practice Implications: Education based on MI could be valuable for MOH patients with respect to behavioural changes and perceived headache control. [ABSTRACT FROM AUTHOR]

Background: Biodegradable polymer drug eluting stents (BP-DES) may offer the advantage of vascular healing in ST-segment elevation myocardial infarction (STEMI). Long-term outcome data comparing BP-DES and second-generation durable polymer drug eluting stents (DP-DES) in STEMI is lacking. This study aims to compare the long-term clinical outcomes of BP-DES versus second-generation DP-DES in STEMI.Methods: This is an observational study of consecutive patients with STEMI who received either BP-DES (n = 854) or DP-DES (n = 708) during primary percutaneous coronary intervention (PCI) from 1st February 2007 to 31st December 2016. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization with follow up till 30th November 2019.Results: The baseline demographics, lesion and procedural characteristic were similar between the two groups except for more prior MI and chronic obstructive pulmonary disease in the BP-DES group. At a median follow up of 4.2 years (interquartile range: 2.6-6.2 years), the incidence of TLF was similar between BP-DES and DP-DES (adjusted hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.70-1.26). Likewise, incidence of major adverse cardiovascular events (MACE: all-cause death, any MI or target vessel revascularization) and definite stent thrombosis were similar in both groups (MACE: adjusted HR 1.04, 95% CI 0.82-1.32; definite stent thrombosis: adjusted HR 1.06, 95% CI 0.31-3.64).Conclusion: Among patients with STEMI who underwent primary PCI, BP-DES and DP-DES implantation was associated with similar long-term clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: A polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed.Methods: All consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up.Results: 1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12-12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES.Conclusions: In this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted. [ABSTRACT FROM AUTHOR]

Background: The Scoreflex NC scoring angioplasty catheter is designed with a short rapid-exchange tip distal to a non-compliant, high-pressure balloon and an integral wire outside of the balloon, such that the guidewire and the integral wire act as scoring elements during balloon inflation. The external scoring elements enable a focal stress pattern facilitating expansion of resistant lesions at lower pressures using a focused force angioplasty effect.Methods: Patients undergoing elective percutaneous coronary intervention (PCI) were enrolled in a prospective, single-arm study conducted at 12 centers in the United States. The primary endpoint was device procedural success, defined as the composite of successful device delivery to the target lesion with balloon inflation and deflation; absence of vessel perforation, flow-limiting dissection or reduction in TIMI flow from baseline; and achievement of final TIMI 3 flow.Results: Among 200 patients (234 lesions), lesion complexities included: bifurcation disease (37.6%), moderate/severe calcification (36.6%), and total occlusions (5.0%). Successful delivery to the target lesion, inflation and removal of the balloon catheter was achieved in 95.5% of patients (191/200). Procedural success was achieved in 93.5% (187/200) of patients, and final TIMI 3 flow was observed in 99.0% of cases (198/200). No unanticipated device-related events occurred. In-hospital major adverse events were reported in 4.5% of patients (9/200), related to periprocedural myocardial infarction (8/200, 4.0%) and target lesion revascularization (1/200, 0.5%).Conclusions: Among patients undergoing elective PCI and with varied lesion complexity, these results support the safety and effectiveness of a dilation strategy using the Scoreflex NC scoring catheter. [ABSTRACT FROM AUTHOR]

Introduction: Awareness of heart attack symptoms and the best response is a national public health priority, especially among those at higher risk of heart disease. Adults with sensory loss are more likely to develop heart disease than those without and may be at risk of poor heart attack knowledge owing to limited patient-provider communication and access to health information. The aim of this study is to examine the association between sensory loss and heart attack knowledge.Methods: Cross-sectional, nationally representative data from the 2014 and 2017 National Health Interview Survey were used. Analyses were conducted in 2021. Participants aged ≥20 years were included (N=61,168). Being aware of heart attack symptoms and the best response was considered as recognizing the 5 examined symptoms of heart attacks and the proper emergency response, as defined in the Healthy People 2020 objectives. Functional hearing and vision losses were defined as self-reported difficulty in hearing and seeing.Results: Overall, 16.2% reported functional hearing loss, and 10.1% reported vision loss. Having vision loss was associated with a lack of knowledge of heart attacks symptoms or the best response (prevalence ratio=1.08, 95% CI=1.06, 1.11). In a separate model, having vision loss only and dual sensory loss (concurrent vision and hearing loss) were associated with not having this knowledge (prevalence ratio=1.09, 95% CI=1.06, 1.12 and PR=1.08, 95% CI=1.01, 1.15, respectively), but having hearing loss only was not (prevalence ratio=1.03, 95% CI=0.99, 1.06).Conclusions: Non-institutionalized adults with sensory loss may represent a group to target for improving the knowledge of heart attacks in the population. [ABSTRACT FROM AUTHOR]

Background: U.S. policy efforts have focused on reducing rural-urban health inequities. However, it is unclear whether gaps in care and outcomes remain among older adults with acute cardiovascular conditions.Objectives: This study aims to evaluate rural-urban differences in procedural care and mortality for acute myocardial infarction (AMI), heart failure (HF), and ischemic stroke.Methods: This is a retrospective cross-sectional study of Medicare fee-for-service beneficiaries aged ≥65 years with acute cardiovascular conditions from 2016 to 2018. Cox proportional hazards models with random hospital intercepts were fit to examine the association of presenting to a rural (vs urban) hospital and 30- and 90-day patient-level mortality.Results: There were 2,182,903 Medicare patients hospitalized with AMI, HF, or ischemic stroke from 2016 to 2018. Patients with AMI were less likely to undergo cardiac catherization (49.7% vs 63.6%, P < 0.001), percutaneous coronary intervention (42.1% vs 45.7%, P < 0.001) or coronary artery bypass graft (9.0% vs 10.2%, P < 0.001) within 30 days at rural versus urban hospitals. Thrombolysis rates (3.1% vs 10.1%, P < 0.001) and endovascular therapy (1.8% vs 3.6%, P < 0.001) for ischemic stroke were lower at rural hospitals. After adjustment for demographics and clinical comorbidities, the 30-day mortality HR was significantly higher among patients presenting to rural hospitals for AMI (HR: 1.10, 95% CI: 1.08 to 1.12), HF (HR: 1.15; 95% CI: 1.13 to 1.16), and ischemic stroke (HR: 1.20; 95% CI: 1.18 to 1.22), with similar patterns at 90 days. These differences were most pronounced for the subset of critical access hospitals that serve remote, rural areas.Conclusions: Clinical, public health, and policy efforts are needed to improve rural-urban gaps in care and outcomes for acute cardiovascular conditions. [ABSTRACT FROM AUTHOR]

Background: The residual lifetime risk (RLR) of developing heart failure (HF) may have changed over time because of the increasing population burden of hypertension, obesity, and diabetes; greater survival after myocardial infarction; and a greater lifespan.Objectives: The authors assessed changes in the RLR for HF in two 25-year epochs (1965-1989 and 1990-2014).Methods: We compared the RLR of HF at age 50 years (adjusting for competing risk of death) in the 2 epochs in Framingham Study participants overall and in the following strata: sex, body mass index, blood pressure, and diabetes.Results: Mean life expectancy increased from 75.9 to 82.1 years in women and 72.5 to 78.1 years in men. We observed 624 HF events over 111,351 person-observations in epoch 1, and 875 HF events over 128,903 person-observations in epoch 2. The mean age at onset of HF increased across the epochs by 6.6 years (women) to 7.2 years (men). The RLR of HF at age 50 years increased across epochs from 18.86% to 22.55% (absolute increase 3.69; 95% CI: 0.90-6.49; P = 0.01) in women, and from 19.19% to 25.25% (absolute increase 6.06; 95% CI: 3.08-9.04; P < 0.001) in men. The increase in RLR of HF in the second epoch was consistent across strata with excess body mass index or higher blood pressure (relative increase of 28%-47%) and in participants without prior myocardial infarction (relative increase of 23%).Conclusions: The RLR of HF has increased in our community-based sample of White individuals over the last 5 decades, possibly caused by an increase in life expectancy. [ABSTRACT FROM AUTHOR]

Background: Lipoprotein(a) [Lp(a)] is associated with increased risk of myocardial infarction, although the mechanism for this observation remains uncertain.Objectives: This study aims to investigate whether Lp(a) is associated with adverse plaque progression.Methods: Lp(a) was measured in patients with advanced stable coronary artery disease undergoing coronary computed tomography angiography at baseline and 12 months to assess progression of total, calcific, noncalcific, and low-attenuation plaque (necrotic core) in particular. High Lp(a) was defined as Lp(a) ≥ 70 mg/dL. The relationship of Lp(a) with plaque progression was assessed using linear regression analysis, adjusting for body mass index, segment involvement score, and ASSIGN score (a Scottish cardiovascular risk score comprised of age, sex, smoking, blood pressure, total and high-density lipoprotein [HDL]-cholesterol, diabetes, rheumatoid arthritis, and deprivation index).Results: A total of 191 patients (65.9 ± 8.3 years of age; 152 [80%] male) were included in the analysis, with median Lp(a) values of 100 (range: 82 to 115) mg/dL and 10 (range: 5 to 24) mg/dL in the high and low Lp(a) groups, respectively. At baseline, there was no difference in coronary artery disease severity or plaque burden. Patients with high Lp(a) showed accelerated progression of low-attenuation plaque compared with low Lp(a) patients (26.2 ± 88.4 mm3 vs -0.7 ± 50.1 mm3; P = 0.020). Multivariable linear regression analysis confirmed the relation between Lp(a) and low-attenuation plaque volume progression (β = 10.5% increase for each 50 mg/dL Lp(a), 95% CI: 0.7%-20.3%). There was no difference in total, calcific, and noncalcific plaque volume progression.Conclusions: Among patients with advanced stable coronary artery disease, Lp(a) is associated with accelerated progression of coronary low-attenuation plaque (necrotic core). This may explain the association between Lp(a) and the high residual risk of myocardial infarction, providing support for Lp(a) as a treatment target in atherosclerosis. [ABSTRACT FROM AUTHOR]

Background: Acute myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high mortality rates. Data has shown that intra-aortic balloon pump (IABP) support does not provide a survival benefit over optimal medical therapy in AMICS. Despite lack of supportive evidence, IABP is still commonly used in these clinical situations. The Impella percutaneous ventricular assist device (PVAD) (Abiomed, Denver, MA) rapidly deploys superior mechanical circulatory support (MCS) in patients with AMICS. However, the safety and efficacy of Impella in AMICS is a matter of ongoing investigation, and its role in AMICS management is not yet fully established.Methods: The databases of Pubmed, EMBASE and Cochrane Central databases were searched from inception to March 2020. Relevant randomized trials and observational studies comparing Impella versus IABP in AMICS were identified and a meta-analysis was performed using the random effect model. The efficacy endpoint of interest was short-term mortality (defined as in-hospital or 30-day mortality). The safety endpoints of interest were major bleeding, limb complications, stroke and hemolysis.Results: A total of 2 randomized trials and 5 observational studies with 3921 patients were included. No difference in short-term mortality between the two groups [RR 1.08, 95% CI 0.87-1.33, P = 0.49] was found. For safety endpoints, Impella was associated with significantly higher incidence of major bleeding [RR: 2.03, 95% CI 1.56-2.64, P < 0.0001], limb complications [RR: 3.67, 95% CI 1.56-8.65, P = 0.003] as well as hemolysis [RR: 9.46, 95% CI 1.75-51.22, P = 0.009] compared with IABP. No significant difference was observed for the incidence of stroke [RR: 1.07 95% CI 0.34-3.31 P = 0.91].Conclusion: Impella support in AMICS patients was associated with a significantly increased risk of bleeding, limb complications and hemolysis without an improved short-term survival advantage compared with IABP. [ABSTRACT FROM AUTHOR]

Background: Pompe disease is a rare, progressive neuromuscular disorder caused by deficiency of acid α-glucosidase (GAA) and accumulation of lysosomal glycogen. We assessed the safety and efficacy of avalglucosidase alfa, a recombinant human GAA enzyme replacement therapy specifically designed for enhanced mannose-6-phosphate-receptor targeting and enzyme uptake aimed at increased glycogen clearance, compared with the current approved standard of care, alglucosidase alfa, in patients with late-onset Pompe disease.Methods: We did a randomised, double-blind, phase 3 trial at 55 sites in 20 countries. We enrolled individuals (aged ≥3 years) with enzymatically confirmed late-onset Pompe disease who had never received treatment. We used a centralised treatment allocation system to randomly allocate participants to either avalglucosidase alfa or alglucosidase alfa. Participants and investigators were unaware of their treatment allocation. The primary outcome measure was change from baseline to week 49 in upright forced vital capacity percent (FVC%) predicted. We used a hierarchical fixed sequential testing strategy, whereby non-inferiority of avalglucosidase alfa compared with alglucosidase alfa was assessed first, with a non-inferiority margin of 1·1. If non-inferiority was seen, then superiority was tested with a 5% significance level. The key secondary objective was effect on functional endurance, measured by the 6-minute walk test (6MWT). Safety was assessed, including treatment-emergent adverse events and infusion-associated reactions. The modified intent-to-treat population was the primary analysis population for all efficacy analyses. The safety population was the analysis population for safety analyses. This trial is registered with ClinicalTrials.gov, NCT02782741. We report results of the 49-week primary analysis period.Findings: Between Nov 2, 2016, and March 29, 2019, 100 participants were randomly allocated avalglucosidase alfa (n=51) or alglucosidase alfa (n=49). Treatment with avalglucosidase alfa resulted in a least-squares mean improvement in upright FVC% predicted of 2·89% (SE 0·88) compared with 0·46% (0·93) with alglucosidase alfa at week 49 (difference 2·43% [95% CI -0·13 to 4·99]). Non-inferiority was shown because the lower bound of the 95% CI for the difference far exceeded the predefined non-inferiority margin but did not exclude 0 (p=0·0074). Superiority was not reached (p=0·063), so formal testing was stopped, as per the testing hierarchy. Improvements were also seen in the 6MWT with avalglucosidase alfa compared with alglucosidase alfa, with greater increases in distance covered (difference 30·01 m [95% CI 1·33 to 58·69]) and percent predicted (4·71% [0·25 to 9·17]). Treatment-emergent adverse events potentially related to treatment were reported in 23 (45%) of 51 participants in the avalglucosidase alfa group and in 24 (49%) of 49 in the alglucosidase alfa group, and infusion-associated reactions were reported in 13 (26%) participants in the avalglucosidase alfa group and 16 (33%) in the alglucosidase alfa group. Of the five trial withdrawals, all in the alglucosidase alfa group, four were due to adverse events, including two infusion-associated reactions. Serious treatment-emergent adverse events were reported in eight (16%) participants who received avalglucosidase alfa and in 12 (25%) who received alglucosidase alfa. One participant treated with alglucosidase alfa died because of acute myocardial infarction determined to be unrelated to treatment. Antidrug antibody responses were similar in both groups. High and persistent titres (≥12 800) and neutralising antibodies were more common with alglucosidase alfa (in 16 [33%] participants) than with avalglucosidase alfa (ten [20%]).Interpretation: We consider that this study provides evidence of clinically meaningful improvement with avalglucosidase alfa therapy over alglucosidase alfa in respiratory function, ambulation, and functional endurance, with no new safety signals reported. An open-label extended-treatment period is ongoing to confirm the long-term safety and efficacy of avalglucosidase alfa, with the aim for this therapy to become the new standard treatment in late-onset Pompe disease.Funding: Sanofi Genzyme. [ABSTRACT FROM AUTHOR]

Background: The study examines the effectiveness of both neurofeedback and motor-imagery brain-computer interface (BCI) training, which promotes self-regulation of brain activity, using low-cost electroencephalography (EEG)-based wearable neurotechnology outside a clinical setting, as a potential treatment for post-traumatic stress disorder (PTSD) in Rwanda.Methods: Participants received training/treatment sessions along with a pre- and post- intervention clinical assessment, (N = 29; control n = 9, neurofeedback (NF, 7 sessions) n = 10, and motor-imagery (MI, 6 sessions) n = 10). Feedback was presented visually via a videogame. Participants were asked to regulate (NF) or intentionally modulate (MI) brain activity to affect/control the game.Results: The NF group demonstrated an increase in resting-state alpha 8-12 Hz bandpower following individual training sessions, termed alpha 'rebound' (Pz channel, p = 0.025, all channels, p = 0.024), consistent with previous research findings. This alpha 'rebound', unobserved in the MI group, produced a clinically relevant reduction in symptom severity in NF group, as revealed in three of seven clinical outcome measures: PCL-5 (p = 0.005), PTSD screen (p = 0.005), and HTQ (p = 0.005).Limitations: Data collection took place in environments that posed difficulties in controlling environmental factors. Nevertheless, this limitation improves ecological validity, as neurotechnology treatments must be deployable outside controlled environments, to be a feasible technological treatment.Conclusions: The study produced the first evidence to support a low-cost, neurotechnological solution for neurofeedback as an effective treatment of PTSD for victims of acute trauma in conflict zones in a developing country. [ABSTRACT FROM AUTHOR]

Background: Noninvasive molecular imaging of recent ischemia can potentially be used to diagnose acute coronary syndrome (ACS) with high accuracy.Objectives: The authors hypothesized that bedside myocardial contrast echocardiography (MCE) ischemic memory imaging could be achieved with phosphatidylserine microbubbles (MBPS) that are retained in the microcirculation via ischemia-associated endothelial activation.Methods: A dose-finding study was performed in healthy volunteers (n = 17) to establish optimal MBPS dosing. Stable patients with ACS (n = 30) and confirmed antecedent but resolved myocardial ischemia were studied within 2 hours of coronary angiography and percutaneous coronary intervention (PCI) when indicated. MCE molecular imaging was performed 8 minutes after intravenous administration of MBPS. MCE perfusion imaging was used to assess the status of the postischemic microcirculation.Results: Based on dose-finding studies, 0.10 or 0.15 mL of MBPS based on body mass was selected. In patients with ACS, all but 2 underwent primary PCI. MCE molecular imaging signal intensity was greater in the postischemic risk area vs remote territory (median [95% CI]: 56 [33-66] vs 8 [2-17] IU; P < 0.001) with a receiver-operating characteristic curve C-statistic of 0.94 to differentiate post-ischemic from remote territory. Molecular imaging signal in the risk area was not related to type of ACS (unstable angina: 3; non-ST-segment elevation myocardial infarction: 14; ST-segment elevation myocardial infarction: 13), peak troponin, time to PCI, post-PCI myocardial perfusion, GRACE (Global Registry of Acute Coronary Events) score, or HEART score.Conclusions: Molecular imaging with point-of-care echocardiography and MBPS can detect recent but resolved myocardial ischemia. This bedside technique requires only minutes to perform and appears independent of the degree of ischemia. (Ischemic Memory Imaging With Myocardial Contrast Echocardiography; NCT03009266). [ABSTRACT FROM AUTHOR]

Objective: To investigate the impact of antidepressants (ATDs) on the risk of myocardial infarction (MI) among patients with diabetes mellitus (DM).Methods: This was a retrospective population-based cohort study that used data obtained from the National Health Insurance Research Database in Taiwan. The study cohort included diabetic patients who were older than 50 years from 1997 to 2010. We then randomly assigned individuals to the matched cohort at a 1:1 ratio according to their demographic data. Both study and matched cohorts were followed up to compare the risk of MI between patients with and without ATD use from 2000 until the end of 2013. Multivariate Cox proportional hazards models were used to evaluate the relationship between ATD treatment and the occurrence of MI.Results: After adjustment for confounders, patients with ATD use of more than 180 days had a lower risk of MI than those without ATD use in the matched cohort (adjusted hazard ratio [HR] = 0.68, 95% confidence interval [CI], 0.66-0.71). The adjusted HRs of MI were 0.77 (95% CI, 0.73-0.81) and 0.56 (95% CI, 052.-0.60) in patients with DM and ATD use of 180 > cDDD ≥ 28 and cDDD ≥ 180, respectively. When the duration of ATD treatment was 180 days or longer, MI risk was significantly reduced (after adjustment) for all classes of ATD except bupropion.Conclusions: Most ATDs, but not bupropion, were associated with significantly reduced risk of MI among the DM population. [ABSTRACT FROM AUTHOR]

Background: The ideal drug-eluting stent (DES) for the treatment of unprotected left main coronary artery (ULMCA) is unknown. We compared percutaneous coronary intervention (PCI) using durable polymers versus early-generation, thicker strutted and coated bioabsorbable polymers for ULMCA disease.Methods: Patients who underwent ULMCA PCI (893 patients) from April 2008 to November 2014 were identified from the Grand-DES registry. The primary end point was 3-year target lesion failure (TLF) after propensity score matching.Results: The final analysis included 754 patients (84.4%) and 139 patients (15.6%) in the durable and bioabsorbable polymer group, respectively. The groups differed significantly in lesion and procedural characteristics. Propensity score-matched analysis revealed a trend toward a lower 3-year TLF in the durable polymer group (log rank p=0.071). Independent predictors of 3-year TLF were chronic kidney disease, presentation with acute myocardial infarction, and a two-stenting technique for ULMCA lesions. Definite/probable stent thrombosis rates at 3-years were low in both groups (0.8% vs. 0.7%, p=0.925).Conclusions: The safety of ULCMA PCI was excellent, and durable and bioabsorbable polymer DES provided similar clinical outcomes at 3-year follow-up. Landmark analysis revealed that the durable polymer group had a lower TLF rate from 9 months. Further studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Introduction: In cardiac arrest, ventricular fibrillation (VF) waveform characteristics such as amplitude spectrum area (AMSA) are studied to identify an underlying myocardial infarction (MI). Observational studies report lower AMSA-values in patients with than without underlying MI. Moreover, experimental studies with 12-lead ECG-recordings show lowest VF-characteristics when the MI-localisation matches the ECG-recording direction. However, out-of-hospital cardiac arrest (OHCA)-studies with defibrillator-derived VF-recordings are lacking.Methods: Multi-centre (Amsterdam/Nijmegen, the Netherlands) cohort-study on the association between AMSA, ST-elevation MI (STEMI) and its localisation. AMSA was calculated from defibrillator pad-ECG recordings (proxy for lead II, inferior vantage point); STEMI-localisation was determined using ECG/angiography/autopsy findings.Results: We studied AMSA-values in 754 OHCA-patients. There were statistically significant differences between no STEMI, anterior STEMI and inferior STEMI (Nijmegen: no STEMI 13.0mVHz [7.9-18.6], anterior STEMI 7.5mVHz [5.6-13.8], inferior STEMI 7.5mVHz [5.4-11.8], p = 0.006. Amsterdam: 11.7mVHz [5.0-21.9], 9.6mVHz [4.6-17.2], and 6.9mVHz [3.2-16.0], respectively, p = 0.001). Univariate analyses showed significantly lower AMSA-values in inferior STEMI vs. no STEMI; there was no significant difference between anterior and no STEMI. After correction for confounders, adjusted absolute AMSA-values were numerically lowest for inferior STEMI in both cohorts, and the relative differences in AMSA between inferior and no STEMI was 1.4-1.7 times larger than between anterior and no STEMI.Conclusion: This multi-centre VF-waveform OHCA-study showed significantly lower AMSA in case of underlying STEMI, with a more pronounced difference for inferior than for anterior STEMI. Confirmative studies on the impact of STEMI-localisation on the VF-waveform are warranted, and might contribute to earlier diagnosis of STEMI during VF. [ABSTRACT FROM AUTHOR]

Background: Patients with sudden cardiac arrest occurring in the acute phase of myocardial infarction (MI-SCA) are believed to be at similar risk of death after revascularization compared with MI patients without SCA (MI-no SCA). Among patients with anterior MI, we examined whether those with MI-SCA were at greater risk of all-cause mortality or sudden cardiac death (SCD) than MI-no SCA patients.Methods: The Home Automated External Defibrillator Trial enrolled patients with anterior MI who had not received or were candidates for an implantable cardioverter defibrillator (ICD). Our cohort included patients with a reported SCA event, in the acute phase of an MI, prior to HAT trial enrollment. Cox proportional hazards models examined the adjusted association between MI-SCA versus MI-no SCA patients and all-cause mortality and sudden cardiac death (SCD). We also determined whether the relationship between prior SCA and outcomes changed with subsequent events (syncope, revascularization, and recurrent MI) during follow-up.Results: Of 6849 patients, 650 (9.5%) had MI-SCA before trial enrollment. Approximately 48% of patients had the MI-SCA event ≤1 year prior to enrollment; 71% of SCA events were in-hospital. MI-SCA patients were younger, more frequently white, and had higher rates of prior PCI versus MI-no SCA patients. There were no differences in adjusted all-cause mortality (hazard ratio [HR 0.95; 95% CI 0.65-1.38]) or SCD (HR 1.12; 95% CI 0.68-1.83) for MI-SCA vs. MI-no SCA. After ICD implantation, MI-SCA patients experienced higher all-cause mortality risk (HR 5.01, 95% CI 1.05-23.79) versus MI-no SCA patients; there was no mortality difference between MI-SCA and MI-no SCA patients without ICD implantation (HR 0.89, 95% CI 0.60-1.31), [interaction p = 0.035].Conclusions: Patients with MI-SCA had similar adjusted risk of all-cause mortality and SCD compared with MI-no SCA. After ICD implantation, MI-SCA patients had higher mortality compared with MI-no SCA patients. [ABSTRACT FROM AUTHOR]

Background: Benefits of intensive blood pressure lowering on health outcomes have been demonstrated in high-risk patients. However, little is known about such benefits in patients with left ventricular hypertrophy (LVH).Objectives: This study sought to investigate the association of on-treatment blood pressure with cardiovascular disease (CVD) risk in adults with hypertension and LVH.Methods: From a nationwide health examination database, this study identified 95,545 participants aged 40-79 years who were taking antihypertensive medication and had LVH on baseline electrocardiography. Using Cox models, HRs and 95% CIs for CVD events were calculated according to systolic blood pressure (SBP) or diastolic blood pressure (DBP).Results: Over a median follow-up of 11.5 years, 12,035 new CVD events occurred. An SBP of <130 mm Hg and DBP of <80 mm Hg were associated with the lowest risk for CVD events in cubic spline models. When the group with SBP of 120-129 mm Hg was the reference, multivariable-adjusted HRs were 1.31 (95% CI: 1.24-1.38) in the ≥140 mm Hg group, 1.08 (95% CI: 1.02-1.15) in the 130-139 mm Hg group, and 1.03 (95% CI: 0.93-1.15) in the <120 mm Hg group. Likewise, when the group with DBP of 70-79 mm Hg was the reference, multivariable-adjusted HRs were 1.30 (95% CI: 1.24-1.37) in the ≥90 mm Hg group, 1.06 (95% CI: 1.01-1.12) in the 80-89 mm Hg group, and 1.08 (95% CI: 0.96 to 1.20) in the <70 mm Hg group.Conclusions: In adults with hypertension and LVH, the risk for CVD events was the lowest at SBP <130 mm Hg and DBP <80 mm Hg. Further randomized trials are warranted to establish optimal blood pressure-lowering strategies for these patients. [ABSTRACT FROM AUTHOR]

Background: The 2018 U.S. cholesterol management guideline recommends additional lipid-lowering therapy with ezetimibe for secondary prevention in very high-risk patients with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL despite maximally tolerated statin.Objectives: The purpose of this study was to evaluate the relationship between baseline LDL-C above and below 70 mg/dL and the benefit of adding ezetimibe to statin in patients post-acute coronary syndrome (ACS).Methods: IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) was a double-blind, placebo-controlled, randomized trial of ezetimibe/simvastatin vs placebo/simvastatin in post-ACS patients followed for 6 years (median). A total of 17,999 patients were stratified by LDL-C at qualifying event into 3 groups (50-<70, 70-<100, and 100-125 mg/dL). The primary endpoint was a composite of cardiovascular death, major coronary events, or stroke.Results: Absolute differences in median LDL-C achieved at 4 months between treatment arms were similar (17-20 mg/dL). The effect of ezetimibe/simvastatin vs placebo/simvastatin on primary endpoint was consistent regardless of baseline LDL-C of 50-<70 mg/dL (HR: 0.92 [95% CI: 0.80-1.05]), 70-<100 mg/dL (HR: 0.93 [95% CI: 0.87-1.01]), or 100-125 mg/dL (HR: 0.94 [95% CI: 0.86-1.03]; P interaction = 0.95). Normalized relative risk reductions per 1-mmol/L difference in achieved LDL-C at 4 months between treatment arms were 21% in patients with baseline LDL-C of 50-<70 mg/dL, 16% in those with 70-<100 mg/dL, and 13% in those with 100-125 mg/dL (P interaction = 0.91). No significant treatment interactions by baseline LDL-C were present for safety endpoints.Conclusions: Adding ezetimibe to statin consistently reduced the risk for cardiovascular events in post-ACS patients irrespective of baseline LDL-C values, supporting the use of intensive lipid-lowering therapy with ezetimibe even in patients with baseline LDL-C <70 mg/dL. (IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin [Ezetimibe/Simvastatin] vs Simvastatin [P04103]; NCT00202878). [ABSTRACT FROM AUTHOR]

Background: REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) randomized statin-treated patients with elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in adjudicated events, including the primary endpoint (cardiovascular [CV] death, myocardial infarction [MI], stroke, coronary revascularization, unstable angina requiring hospitalization) and key secondary endpoint (CV death, MI, stroke) with IPE.Objectives: The purpose of this study was to determine the effects of IPE on investigator-reported events.Methods: Potential endpoints were collected by blinded site investigators and subsequently adjudicated by a blinded Clinical Endpoint Committee (CEC) according to a prespecified charter. Investigator-reported events were compared with adjudicated events for concordance.Results: There was a high degree of concordance between investigator-reported and adjudicated endpoints. The simple Kappa statistic between CEC-adjudicated vs site-reported events for the primary endpoint was 0.89 and for the key secondary endpoint was 0.90. Based on investigator-reported events in 8,179 randomized patients, IPE significantly reduced the rate of the primary endpoint (19.1% vs 24.6%; HR: 0.74 [95% CI: 0.67-0.81]; P < 0.0001) and the key secondary endpoint (10.5% vs 13.6%; HR: 0.75 [95% CI: 0.66-0.85]; P < 0.0001). Among adjudicated events, IPE similarly reduced the rate of the primary and key secondary endpoints.Conclusions: IPE led to consistent, significant reductions in CV events, including MI and coronary revascularization, as determined by independent, blinded CEC adjudication as well as by blinded investigator-reported assessment. These results highlight the robust evidence for the substantial CV benefits of IPE seen in REDUCE-IT and further raise the question of whether adjudication of CV outcome trial endpoints is routinely required in blinded, placebo-controlled trials. (Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT [Reduction of Cardiovascular Events With EPA - Intervention Trial]; NCT01492361). [ABSTRACT FROM AUTHOR]

Background: Circulating ketone bodies (KBs) are increased in patients with heart failure (HF), corresponding with increased cardiac KB metabolism and HF severity. However, the role of circulating KBs in ischemia/reperfusion remains unknown.Objectives: This study sought to investigate longitudinal changes of KBs and their associations with functional outcomes in patients presenting with ST-segment elevation myocardial infarction (STEMI).Methods: KBs were measured in 369 participants from a randomized trial on early metformin therapy after STEMI. Nonfasting plasma concentrations of KBs (β-hydroxybutyrate, acetoacetate, and acetone) were measured by nuclear magnetic resonance spectroscopy at presentation, at 24 hours, and after 4 months. Myocardial infarct size and left ventricular ejection fraction (LVEF) were determined by cardiac magnetic resonance imaging at 4 months. Associations of circulating KBs with infarct size and LVEF were determined using multivariable linear regression analyses.Results: Circulating KBs were high at presentation with STEMI (median total KBs: 520 μmol/L; interquartile range [IQR]: 315-997 μmol/L). At 24 hours after reperfusion, KBs were still high compared with levels at 4-month follow-up (206 μmol/L [IQR: 174-246] vs 166 μmol/L [IQR: 143-201], respectively; P < 0.001). Increased KB concentrations at 24 hours were independently associated with larger myocardial infarct size (total KBs, per 100 μmol/L: β = 1.56; 95% confidence interval: 0.29-2.83; P = 0.016) and lower LVEF (β = -1.78; 95% CI: (-3.17 to -0.39; P = 0.012).Conclusions: Circulating KBs are increased in patients presenting with STEMI. Higher KBs at 24 hours are associated with functional outcomes after STEMI, which suggests a potential role for ketone metabolism in response to myocardial ischemia. (Metabolic Modulation With Metformin to Reduce Heart Failure After Acute Myocardial Infarction: Glycometabolic Intervention as Adjunct to Primary Coronary Intervention in ST Elevation Myocardial Infarction (GIPS-III): a Randomized Controlled Trial; NCT01217307). [ABSTRACT FROM AUTHOR]

Background: Patients with suspected acute coronary syndrome in whom myocardial infarction has been excluded are at risk of future adverse cardiac events.Objectives: This study evaluated the usefulness of high-sensitivity cardiac troponin I (hs-cTnI) to select patients for further investigation after myocardial infarction has been excluded.Methods: This is a prospective cohort study of patients presenting to the emergency department with suspected acute coronary syndrome and hs-cTnI concentrations below the sex-specific 99th percentile. Patients were recruited in a 2:1 fashion, stratified by peak hs-cTnI concentration above and below the risk stratification threshold of 5 ng/L. All patients underwent coronary computed tomography angiography (CCTA) after hospital discharge.Results: Overall, 250 patients were recruited (61.4 ± 12.2 years 31% women) in whom 62.4% (156 of 250 patients) had coronary artery disease (CAD). Patients with intermediate hs-cTnI concentrations (between 5 ng/L and the sex-specific 99th percentile) were more likely to have CAD than those with hs-cTnI concentrations <5 ng/L (71.9% [120 of 167 patients] vs 43.4% [36 of 83 patients]; odds ratio: 3.33; 95% CI: 1.92-5.78). Conversely, there was no association between anginal symptoms and CAD (63.2% [67 of 106 patients] vs 61.8% [89 of 144 patients]; odds ratio: 0.92; 95% CI: 0.48-1.76). Most patients with CAD did not have a previous diagnosis (53.2%; 83 of 156 patients) and were not on antiplatelet and statin therapies (63.5%; 99 of 156 patients) before they underwent CCTA.Conclusions: In patients who had myocardial infarction excluded, CAD was 3× more likely in those with intermediate hs-cTnI concentrations compared with low hs-cTnI concentrations. In such patients, CCTA could help to identify those with occult CAD and to target preventative treatments, thereby improving clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease is the leading cause of death for women in the United States. Revascularization is considered the standard of care for treatment of ST-segment elevation myocardial infarction (STEMI) and is known to reduce readmission. However there is a paucity of data that examines the sex-dependent impact of revascularization on readmission. We aimed to investigate sex differences in revascularization rates, 30-day readmission rates, and primary cause of readmissions following STEMIs.Methods: STEMI hospitalizations were selected in the Nationwide Readmissions Database from 2010 to 2014. Revascularization rates, 30-day readmission rates, and primary cause of readmission were examined. Interaction between sex and revascularization was assessed. Multivariable regression analysis was performed to identify predictors of 30-day readmission and revascularization for both sexes.Results: 219,944 women and 489,605 men were admitted with STEMIs. Women were more likely to be older, and have more comorbidities. Women were less likely to undergo revascularization by percutaneous coronary intervention (adjusted odds ratio [OR]: 0.68; 95% confidence interval [CI]: 0.66-0.70) or coronary artery bypass graft surgery (adjusted OR 0.40; CI 0.39-0.44). Women had higher 30-day readmission rates (15.7% vs. 10.8%, p < 0.001; OR 1.20, CI 1.17-1.23), and revascularization in women was not associated with a decreased likelihood of 30-day readmission. The primary cardiac cause of readmission in women was heart failure.Conclusion: Compared to men, women with STEMIs had lower rates of revascularization and higher rates of 30-day readmission. When revascularized, women were still more likely to be readmitted as compared to non-revascularized women. [ABSTRACT FROM AUTHOR]