Gender-related differences in changes of estimated bleeding risk in patients on dual antiplatelet therapy: the RE-SCORE multicenter prospective registry.

The risk of bleeding as predicted by the PRECISE-DAPT score can vary over time after percutaneous coronary intervention (PCI). We sought to compare the predictive ability of the PRECISE-DAPT score calculated at baseline and reassessed during follow-up in male and female patients undergoing PCI. The RE-SCORE was a multicenter, prospective registry including patients undergoing PCI treated with dual antiplatelet therapy (DAPT) for 1 year. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. The PRECISE-DAPT score was determined for each patient at the time of PCI and at 1, 4 and 8-month follow-up visits or before the occurrence of an endpoint event. A total of 480 patients undergoing PCI were included. At baseline, median PRECISE-DAPT score was similar in males (23.2 [IQR 20.1-24.2]) and females (23.4 [IQR 20.2-25.3]; p = .22). During follow-up, an increase in the PRECISE-DAPT occurred significantly more often in females (44%) than in males (23%; p < .001). The discrimination of the PRECISE-DAPT score calculated at baseline was marginal in both males (c-index = 0.59, 95% CI: 0.51-0.65) and females (c-index = 0.55, 95% CI: 0.49-0.60). The discriminative ability of the score reassessed at follow-up was excellent in females (c-index = 0.84; 95% CI: 0.77-0.91) but remained modest in males (c-index = 0.61; 95% CI: 0.55-0.70). The bleeding predictive ability of the PRECISE-DAPT score can vary over time, more commonly in females than males. The discrimination of the score calculated during follow-up appeared improved in females but remained modest in males.Clinical Trial Registration - ClinicalTrials.gov Identifier: NCT03526614.

342 Impact of temporary traffic bans on the risk of acute coronary syndromes in a large metropolitan area.

Aims: Strong epidemiologic evidence has highlighted the role of pollution, on top of adverse climate features, as a novel cardiovascular risk factor. However, mechanistic proof that reducing pollution may be beneficial to prevent atherothrombotic events is limited. We aimed at appraising the impact of temporary traffic bans in a large metropolitan area on the risk of acute coronary syndromes. Methods and results: Aggregate and anonymized data from 15 tertiary cardiac care centers were obtained detailing pre-coronarivus disease 2019 (COVID-19) daily cases of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), including those treated with percutaneous coronary intervention (PCI). Data on pollutants and climate were sought for the same days. Mixed level regression was used to compare the week before vs. after the traffic ban (Fortnight analysis), the 3 days before vs. after (Weekly analysis) and the Sunday before vs. after (Sunday analysis). A total of 8 days of temporary traffic bans were included, occurring between 2017 and 2020, totaling 802 STEMI and 1196 NSTEMI in the Fortnight analysis, 382 STEMI and 585 in the Weekly analysis, and 148 STEMI and 210 NSTEMI in the Sunday analysis. Fortnight and Sunday analysis did not disclose a significant impact of traffic ban on STEMI or NSTEMI (all P > 0.05). Conversely, Weekly analysis showed non-significant changes for STEMI but a significant decrease in daily NSTEMI when comparing the 3 days before the traffic ban with the ban day (P = 0.043), as well as the 3 days before vs. the 3 days after the ban (P = 0.025). No statistically significant effect of traffic ban was found at Fortnight, Weekly or Sunday analyses for daily mean concentrations of benzene, carbon monoxide, nitric oxide, nitrogen dioxide, ozone, sulfur dioxide, particulate matter (PM) <2.5 µm or PM < 10 µm (all P > 0.05). However, minimum daily concentrations showed a significant reduction of ozone during the ban in comparison to the week preceding it (P = 0.034), nitric oxide during the ban in comparison to the 3 days preceding it (P = 0.046), and an increase in benzene during the ban in comparison to the Sunday before (P = 0.039). Conclusion: Temporary traffic bans may favorably reduce coronary atherothrombotic events, and in particular NSTEMI, even if not globally and immediately impacting on environmental pollution. Further controlled studies are required to confirm and expand this hypothesis-generating results.

Core valve implant failure in the presence of mechanical mitral prosthesis: importance of assessing left ventricular outflow tract.

Transcatheter aortic valve replacement in the presence of a mitral prosthetic valve is a technically challenging endeavor. The presence of a mitral prosthesis can alter the geometry of the landing zone for the device. A multi slice computerized tomography with comprehensive review of left ventricular outflow tract and aortic root in its entirety is critical for preventing implant failure. Technical expedients to treat implant failure involve understanding of the device as well its relationship with the mitral prosthesis.

Clinical effects of routine postdilatation of drug-eluting stents.

OBJECTIVES: To assess the clinical effects of postdilatation of drug-eluting stents (DES). BACKGROUND: Subotpimal stent expansion occurs after DES deployment. Postidlatation may improve DES expansion, but it is unclear whether postdilatation may also improve clinical outcomes. METHODS: Since July 2009, we adopted a strategy of routine postdilatation with noncompliant balloons of all DES, while previously postdilatation was performed only for suboptimal results. The first 279 consecutive patients (age 62 ± 9 years, 231 men) who underwent routine postilatation were compared with 262 patients (age 61 ± 9 years, 220 men) who received DES in the previous 6 months (standard treatment). RESULTS: The two groups were similar for age, sex, clinical presentation, and main risk factors, including incidence of diabetes. Routine postdilatation resulted in an improved minimal lumen diameter at the end of the procedure (2.60 ± 0.34 vs. 2.51 ± 0.37 mm, P = 0.003). At 12-month follow-up incidence of MACE (including periprocedural myocardial infarction) was 19.5% in the standard treatment group and 12.5% in routine postdilatation group (P = 0.04), with a significant difference in target vessel revascularization (10.7% vs. 5.4%, P = 0.03), while incidence of myocardial infarction was not significantly different between the two groups (10.7% vs. 9.3%, P = 0.70). Stent thrombosis (definite or probable) occurred in 3 patients in standard treatment group, while no case of stent thrombosis occurred among patients treated with routine postdilatation (1.1% vs. 0%, P = 0.11). CONCLUSIONS: Our results suggest that a strategy of routine postdilatation with non compliant balloons may improve clinical outcomes of DES.

Endothelial progenitor cells predict long-term prognosis in patients with stable angina treated with percutaneous coronary intervention: five-year follow-up of the PROCREATION study.

BACKGROUND: The association between endothelial progenitor cells (EPCs) at the time of percutaneous coronary intervention (PCI) and the subsequent long-term clinical outcome remains undefined. To address this issue, a pre-specified analysis of the PROgenitor Cells role in Restenosis and progression of coronary ATherosclerosis after percutaneous coronary intervention (PROCREATION) study was done. METHODS AND RESULTS: A total of 155 patients with stable angina treated with PCI had flow cytometry before PCI. Patients had a 5-year follow-up. Primary outcome was the composite of major adverse cardiac or cerebrovascular events (MACCE), that is, death, stroke, myocardial infarction, and revascularization. During follow-up, MACCE occurred in 65 of 155 patients (42%). There were no significant differences in clinical and angiographic variables between patients with or without MACCE, apart from a different extent of coronary atherosclerosis. The incidence of MACCE increased significantly over tertiles of CD34+/KDR+/CD45- cells and CD133+/KDR+/CD45- cells, with rates of 25%, 39%, and 69% (P=0.0001), and 26%, 44%, and 59% (P=0.003), respectively. On multivariate analysis it was estimated that the increase in CD34+/KDR+/CD45- cells was associated with a 35% higher risk for MACCE (hazard ratio [HR], 1.75; 95% confidence interval [CI]: 1.07-1.99; P=0.001), and the increase in CD133+/KDR+/CD45- cells was associated with a 25% higher risk for MACCE (HR, 1.35; 95% CI: 1.01-1.74; P=0.03). CONCLUSIONS: Assessment of subpopulations of circulating EPCs in patients with stable angina treated with PCI can improve characterization of long-term prognosis (ClinicalTrials.gov: NCT01575431).

Early beneficial effects of drug-eluting stents in vein grafts wane during long term follow-up: a case-control study.

OBJECTIVES: The aim of the study was to compare outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein graft (SVG) interventions in a case-control study with a long-term follow-up. BACKGROUND: Safety and efficacy of DES in SVG interventions are still controversial. METHODS: We performed a multicenter registry assessing clinical outcomes with DES vs. BMS. We included 311 patients (239 men, age 68 ± 8 years) who underwent percutaneous coronary interventions (PCI) of SVG lesions with DES (n = 138) or BMS (n = 173) with a 2-year follow-up. RESULTS: The two groups were similar for age, sex, main risk factors, incidence of diabetes, use of IIb/IIIa antagonists, use of aspiration devices or filters, number of stents, and total stent length. Overall, at 9 months follow-up incidence of major adverse cardiac events (MACE) and target vessel revascularization (TVR) were significantly lower in the DES group compared with the BMS group (10.9% vs. 22.0%, P = 0.014 and 8.7% vs. 19.1% in DES and BMS respectively, P = 0.015), while there was no significant difference in incidence of myocardial infarction (5.1% vs. 5.2%, P = 0.96) or death (2.2% vs. 4%, respectively, P = 0.54). However, at 24-month follow-up incidence of MACE was 29.7% in the DES group and 37.0% in BMS group (P = 0.29); incidence of TVR (23.2% vs. 28.9% P = 0.39), myocardial infarction (9.4% vs. 9.2%), death (7.2% vs. 6.9%) were also similar in the two groups. CONCLUSIONS: Although DES appear safe, our findings suggest that the early benefit of DES in SVG may rapidly wane during long-term follow-up.

PSYChosomatic Medicine in ONcologIc and Cardiac Disease (PSYCHONIC) Study-A Retrospective and Prospective Observational Research Protocol.

Psychosocial factors play an important role in non-communicable diseases (NCDs). This observational study is primarily aimed at assessing the relationship of psychological characteristics of patients with the outcomes of different NCDs, and to assess short-term psychotherapy (STP) efficacy in the real world. Methods: One hundred and forty patients with recent acute myocardial infarction, Takotsubo syndrome, or non-metastatic breast cancer and a control group of 140 age and sex-matched healthy subjects, will be enrolled. All subjects will be administered psychometric tests, quality of life tests, a specific body perception questionnaire, a dream questionnaire, and a projective test, the Six Drawing test at baseline and follow-up. All subjects with medical conditions will be asked to freely choose between an ontopsychological STP along with standard medical therapy and, whenever indicated, rehabilitation therapy or medical therapy plus rehabilitation alone. The study endpoints will be to evaluate: the relationship of the psychological characteristics of enrolled subjects with the outcomes of different NCDs, predictors of the choice of psychotherapy, and the efficacy of ontopsychological intervention on psychological and medical outcomes. Conclusion: This study will generate data on distinctive psychological characteristics of patients suffering from different CDs and their relationship with medical outcomes, as well as explore the efficacy of ontopsychological STP in these patients in the real world. (Number of registration: NCT03437642).

Interplay between COVID-19, pollution, and weather features on changes in the incidence of acute coronary syndromes in early 2020.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has caused an unprecedented change in the apparent epidemiology of acute coronary syndromes (ACS). However, the interplay between this disease, changes in pollution, climate, and aversion to activation of emergency medical services represents a challenging conundrum. We aimed at appraising the impact of COVID-19, weather, and environment features on the occurrence of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) in a large Italian region and metropolitan area. METHODS AND RESULTS: Italy was hit early on by COVID-19, such that state of emergency was declared on January 31, 2020, and national lockdown implemented on March 9, 2020, mainly because the accrual of cases in Northern Italy. In order to appraise the independent contribution on changes in STEMI and NSTEMI daily rates of COVID-19, climate and pollution, we collected data on these clinical events from tertiary care cardiovascular centers in the Lazio region and Rome metropolitan area. Multilevel Poisson modeling was used to appraise unadjusted and adjusted effect estimates for the daily incidence of STEMI and NSTEMI cases. The sample included 1448 STEMI and 2040 NSTEMI, with a total of 2882 PCI spanning 6 months. Significant reductions in STEMI and NSTEMI were evident already in early February 2020 (all p<0.05), concomitantly with COVID-19 spread and institution of national countermeasures. Changes in STEMI and NSTEMI were inversely associated with daily COVID-19 tests, cases, and/or death (p<0.05). In addition, STEMI and NSTEMI incidences were associated with daily NO2, PM10, and O3 concentrations, as well as temperature (p<0.05). Multi-stage and multiply adjusted models highlighted that reductions in STEMI were significantly associated with COVID-19 data (p<0.001), whereas changes in NSTEMI were significantly associated with both NO2 and COVID-19 data (both p<0.001). CONCLUSIONS: Reductions in STEMI and NSTEMI in the COVID-19 pandemic may depend on different concomitant epidemiologic and pathophysiologic mechanisms. In particular, recent changes in STEMI may depend on COVID-19 scare, leading to excess all-cause mortality, or effective reduced incidence, whereas reductions in NSTEMI may also be due to beneficial reductions in NO2 emissions in the lockdown phase.

Safety of drug eluting stents in patients on chronic anticoagulation using long-term single antiplatelet treatment with clopidogrel.

BACKGROUND: Use of triple therapy with aspirin, clopidogrel, and anticoagulants significantly increases bleeding, thus drug eluting stents (DES) are usually avoided in patients requiring anticoagulation. We tested use of DES vs. BMS using a long-term therapy with clopidogrel only and anticoagulants in this group of patients. METHODS: We enrolled 165 consecutive patients, 79 receiving DES (age 67 +/- 9 years, 84% with atrial fibrillation) and 86 receiving bare metal stents (BMS) (age 70 +/- 11 years, 71% with atrial fibrillation). All patients received aspirin + clopidogrel + oral anticoagulants for 4 weeks, then aspirin was stopped and clopidogrel was continued during the 12-month follow-up. Primary end point was the combined incidence of major adverse coronary events and major bleedings. RESULTS: Incidence of the primary endpoint was 10.1% in patients with DES and 26.7% in patients with BMS (P = 0.01). There was a large difference in incidence of target vessel revascularization (8.1% for DES, 23.3% for BMS, P = 0.01), whereas incidence of myocardial infarction (3.8% in DES vs. 8.1% in BMS) and major bleeding (1.3% vs. 2.3%, respectively) were not significantly different. There were no cases of stent thrombosis. On multivariate Cox regression analysis, the only factor associated with a reduced risk of the primary endpoint was use of DES (hazard ratio 0.35 with 95% confidence interval 0.14-0.85, P = 0.02). CONCLUSIONS: Results of our cohort study suggest that use of DES associated with a treatment with clopidogrel only may be safe and significantly reduce the need for new revascularization in patients requiring chronic anticoagulation.

Malignancy in patients with myocardial infarction and non-obstructive coronary arteries: A systematic review and meta-regression.

BACKGROUND: The significance of malignancy in patients with myocardial infarction and non-obstructive coronary arteries (MINOCA) is poorly defined. This study aimed at determining the prevalence of malignancy and its association with long-term outcome in MINOCA. METHODS: We searched the MEDLINE, EMBASE, and CENTRAL databases up to March 31, 2020 to identify studies reporting data on malignancy in full. We performed a random effects meta-analysis of proportions and assessed statistical heterogeneity using the I2 statistic and meta-regression analysis. RESULTS: A total of 9 studies including 26,636 patients (11,910 men and 14,726 women) were selected for the meta-analysis. Of them, 655 patients (2.5%) had a diagnosis of malignancy at presentation. Comparison of presenting features and outcome between patients with MINOCA and patients with myocardial infarction and coronary artery disease (MI-CAD) showed that malignancy was significantly more common in the former as compared with the latter (p = 0.019). During a median follow-up of 39 months, 2,081 patients with MINOCA died (7.8%). Meta-regression analysis demonstrated that long-term mortality was associated with left ventricular ejection fraction (p = 0.0001; coefficient: -0.001; 95% CI: from -0.002 to 0.002), malignancy at presentation (p = 0.01; coefficient: 0.001; 95% CI: from -0.001 to 0.001), and use of beta-blockers during follow-up (p = 0.03; coefficient: 0.001; 95% CI: from -0.000 to 0.001). CONCLUSION: This study shows that the prevalence of malignancy in patients with MINOCA is not trivial and is significantly greater than in patients with MI-CAD. Malignancy is significantly associated with an unfavorable long-term prognosis in MINOCA.

Safety and Outcome of Rheolytic Thrombectomy for the Treatment of Acute Massive Pulmonary Embolism.

BACKGROUND: Percutaneous rheolytic thrombectomy is an attractive alternative to thrombolytic therapy in patients with acute pulmonary embolism (PE), but its use is currently discouraged due to safety concerns. METHODS: We studied 33 consecutive patients (age, 43 ± 13 years; 20 men and 13 women) with acute PE and contraindications to thrombolytic therapy who had rheolytic thrombectomy with the AngioJet catheter (Boston Scientific). Acute massive PE was initially diagnosed by computed tomography and then confirmed by pulmonary angiography. Pulmonary thrombus location was evaluated prior to the procedure. Anemia was defined as a decrease in hematocrit level <39% for men and <36% for women. Renal failure was defined as oliguria (urine output <500 mL/24 hours) or an increase in creatinine (>25% over baseline or an overall increase by 1 g/dL). RESULTS: Catheter thrombectomy resulted in angiographic improvement in 32 patients (96%), with a rapid amelioration in functional class (from 3.3 ± 0.9 to 2.1 ± 0.7; P<.001) and an increase in oxygen saturation (from 71 ± 15% to 92 ± 17%; P<.001). No patient died. Side effects included transient heart block (n = 1), hypotension (n = 3), and bradycardia (n = 5). Anemia occurred in 4 patients, while renal failure was not detected. Clinical improvement was maintained during follow-up. At 1 year, systolic pulmonary pressure was significantly lower than at baseline (65 ± 31 mm Hg vs 31 ± 19 mm Hg; P<.001). CONCLUSIONS: Catheter thrombectomy with AngioJet in patients with acute massive PE and contraindications to thrombolysis is an effective therapeutic alternative that is not associated with relevant and persistent side effects, including the risk of death or developing anemia and renal failure.

Endothelial progenitor cells predict long-term outcome in patients with coronary artery disease: Ten-year follow-up of the PROCREATION extended study.

BACKGROUND: Levels of circulating endothelial progenitor cells (EPCs) are associated with the short-term prognosis of patients with coronary artery disease (CAD). No previous study, however, has ascertained if EPCs are related also to long-term outcome. We performed a pre-specified analysis of the PROCREATION (PROgenitor Cells role in Restenosis and progression of coronary ATherosclerosis after percutaneous coronary intervention) study in order to assess if EPCs predict the 10-year prognosis. METHODS AND RESULTS: Consecutive stable patients with CAD who were included in the PROCREATION study were evaluated. Patients underwent an extended 10-year follow-up to assess major adverse cardiac or cerebrovascular events (MACCE), i.e. death, stroke, myocardial infarction, and revascularization. During follow-up, MACCE occurred in 79 of 149 patients (53%). Most clinical and angiographic baseline variables were similar in patients with or without MACCE, apart from age, diabetes, chronic kidney disease, ejection fraction, and extent of CAD. Comparison of EPCs, conversely, showed that patients with MACCE had greater levels of CD34+/KDR+/CD45- cells (p=0.0002) and CD133+/KDR+/CD45- cells (p=0.0001). Multivariate analysis showed that factors independently associated with 10-year MACCEs were age (p=0.001), ejection fraction (p=0.018), and CD34+/KDR+/CD45- cells (p=0.024). CONCLUSION: Subpopulations of EPCs can improve long-term risk factor characterization in patients with CAD. (ClinicalTrials.gov: NCT01575431).

Predictors of Mortality in Myocardial Infarction and Nonobstructed Coronary Arteries: A Systematic Review and Meta-Regression.

BACKGROUND: The long-term mortality of patients with myocardial infarction and nonobstructed coronary arteries (MINOCA) remains poorly defined. This study aimed to determine the long-term mortality of patients with MINOCA and to identify potential prognostic determinants of long-term outcome. METHODS: We searched PubMed, EMBASE, and Cochrane databases and reviewed cited references up to December 31, 2018 to identify studies with >6 months' follow-up data. RESULTS: We selected 44 studies including 36,932 patients (20,052 women and 16,880 men). During a median follow-up of 25 months (interquartile range: 23-39 months), 1409 patients had died (3.8%). Overall, annual mortality rate was 2.0% (95% confidence interval [CI]: 1.5% to 2.4%), with significant heterogeneity (I2 = 80%, P < .001). Meta-analysis of the 26 studies comparing patients with MINOCA with those with myocardial infarction and obstructive coronary artery disease showed that annual rates of long-term total mortality were 2.2% (95% CI: 1.7% to 2.7%) and 5.0% (95% CI: 4.1% to 5,9%), respectively, with a significant difference between the two groups (relative risk: 0.60, 95% CI: 0.46 to 0.78, P < .001). Meta-regression analysis demonstrated that normal ejection fraction (P ≤ .0001) and normal coronary arteries at angiography (P = .004) were inversely related to long-term mortality, whereas use of beta-blockers during follow-up (P = .010) and ST depression on the admission electrocardiogram (P = .016) were directly related with worse outcome. CONCLUSIONS: The long-term mortality after MINOCA is lower than that in patients with myocardial infarction and obstructive coronary artery disease, but it is not trivial. Reduced ejection fraction, nonobstructive coronary artery disease, use of beta-blockers during follow up and ST depression on the admission electrocardiogram are significant predictors of long-term prognosis.

Impact of temporary traffic bans on the risk of acute coronary syndromes in a large metropolitan area.

BACKGROUND: Strong epidemiologic evidence has highlighted the role of pollution, on top of adverse climate features, as a novel cardiovascular risk factor. However, mechanistic proof that reducing pollution may be beneficial to prevent atherothrombotic events is limited. We aimed at appraising the impact of temporary traffic bans in a large metropolitan area on the risk of acute coronary syndromes. METHODS: Aggregate and anonymized data from 15 tertiary cardiac care centers were obtained detailing precoronavirus disease 2019 (COVID-19) daily cases of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), including those treated with percutaneous coronary intervention (PCI). Data on pollutants and climate were sought for the same days. Mixed level regression was used to compare the week before vs after the traffic ban (Fortnight analysis), the 3 days before vs. after (Weekly analysis) and the Sunday before vs. after (Sunday analysis). RESULTS: A total of 8 days of temporary traffic bans were included, occurring between 2017 and 2020, totaling 802 STEMI and 1196 NSTEMI in the Fortnight analysis, 382 STEMI and 585 in the Weekly analysis, and 148 STEMI and 210 NSTEMI in the Sunday analysis.Fortnight and Sunday analyses did not disclose a significant impact of traffic ban on STEMI or NSTEMI (all P>0.05). Conversely, Weekly analysis showed non-significant changes for STEMI, but a significant decrease in daily NSTEMI when comparing the 3 days before the traffic ban with the ban day (P=0.043), as well as the 3 days before vs. the 3 days after the ban (P=0.025). No statistically significant effect of traffic ban was found at Fortnight, Weekly or Sunday analyses for daily mean concentrations of benzene, carbon monoxide, nitric oxide, nitrogen dioxide, ozone, sulfur dioxide, particulate matter (PM) <2.5 µm or PM <10 µm (all P>0.05). However, minimum daily concentrations showed a significant reduction of ozone during the ban in comparison to the week preceding it (P=0.034), nitric oxide during the ban in comparison to the 3 days preceding it (P=0.046), and an increase in benzene during the ban in comparison to the Sunday before (P=0.039). CONCLUSIONS: Temporary traffic ban may favorably reduce coronary atherothrombotic events, and in particular NSTEMI, even if not globally and immediately impacting on environmental pollution. Further controlled studies are required to confirm and expand this hypothesis-generating results.

Transcathether occlusion of interatrial communications: postprocedural transoesophageal echocardiography allows timely detection and treatment of intracardiac thrombus formation.

AIMS: Thrombus formation leading to ischaemic stroke is a major concern after transcathether occlusion of interatrial communications. The aim of our study was to verify if postprocedural transoesophageal echocardiography (TEE) might improve timely detection and management of thrombus formation. METHODS AND RESULTS: We studied 65 patients with patent foramen ovale or atrial septal defect who received an atrial septal closure device. Transoesophageal echocardiography was used to guide the procedure, and was repeated <1 h after the end of the procedure, at 30 day and 6 month follow-up visits. Transoesophageal echocardiography <1 h after procedure revealed a left-sided thrombus attached to the device in three patients. All cases were successfully treated by thrombolytic therapy with full-dose tenecteplase (0.53 mg/kg in 5-10 s) with disappearance of thrombus in 15-60 min. No cerebrovascular event was recorded during a follow-up of 311 +/- 235 days. CONCLUSION: Thrombus formation on interatrial closure devices can occur soon after device implantation and can be timely detected by postprocedural TEE.

Risk Factors for Ischemic Heart Disease.

BACKGROUND: Several risk factors have been empirically linked to an increased risk of cardiovascular disease. Some of them are therapeutically amenable to modification; while others are not. Modifiable risk factors include physical inactivity, tobacco use, diet, "bad fats" in the blood, hypertension, and being overweight; while non-modifiable risk factors include the patient's family history, the presence versus absence of diabetes mellitus, and demographic characteristics like age, gender, ethnicity, and socio-economic status. METHODS: In this article, we review those risk factors that are both clinically important and amenable to change. CONCLUSION: To prevent cardiovascular disease, it is important to minimize modifiable risk factors, like LDL cholesterol.

Short-TErm Psychotherapy IN Acute Myocardial Infarction (STEP-IN-AMI) Trial: Final Results.

PURPOSE: The purpose of this research was to assess whether short-term psychotherapy enhances long-term clinical outcomes in patients with a recent acute myocardial infarction (AMI). METHODS: Patients ≤70 years old were randomized within 1 week of their AMI to short-term ontopsychological psychotherapy plus routine medical therapy vs routine medical therapy only. The primary composite outcome was defined as the combined incidence of new cardiovascular events (re-infarction, death, stroke, revascularization, life-threatening ventricular arrhythmias, and the recurrence of clinically significant angina) and clinically significant new comorbidities. Secondary outcome measures were: rates for individual components of the primary composite outcome; the rate of re-hospitalization for cardiovascular problems; and New York Heart Association functional class. RESULTS: Ninety-four patients were analyzed, translating into 425 patient-years. The 2 treatment groups were similar across baseline characteristics. At 5-year follow-up, psychotherapy patients had a lower incidence of primary outcome, relative to controls (77/223 vs 98/202 patient-years, respectively; P = .035; absolute risk reduction = 19%, number needed to treat = 8); this benefit was attributable to the lower incidence of new comorbidities and clinically significant angina in the psychotherapy group. Gains in the primary outcome, relative to controls, among psychotherapy patients occurred in the first year and subsequently remained stable over the following 4 years. CONCLUSIONS: Adding short-term ontopsychological psychotherapy to routine secondary prevention of myocardial infarction improves clinical outcomes overall up to 5 years post AMI. Studying time trends may aid in better targeting of psychological interventions during follow-up. Larger studies remain necessary to confirm these results. TRIAL REGISTRATION: www.ClinicalTrial.gov NCT00769366.

Meta-Regression to Identify Patients Deriving the Greatest Benefit from Dual Antiplatelet Therapy after Stroke or Transient Ischemic Attack Without Thrombolytic or Thrombectomy Treatment.

The patient's profile drawing the greatest benefit from dual antiplatelet therapy (DAPT) after a noncardioembolic, ischemic cerebrovascular event is not well characterized. Aim of this metaregression analysis was to compare DAPT versus single antiplatelet therapy (SAPT) in patients with stroke or transient ischemic attack (TIA). We searched randomized trials evaluating clinical outcome with aspirin plus a P2Y12 inhibitor versus SAPT in patients with noncardioembolic stroke or TIA. Primary end point was the incidence of recurrent stroke; safety outcome measure was major bleeding. Eleven trials were included in the analysis, enrolling 24,175 patients treated with DAPT (aspirin plus clopidogrel, n = 12,074) or SAPT (n = 12,101) after a stroke or TIA event. In the DAPT group the rates of recurrent stroke were lower (7.1% vs 8.8% with SAPT; odds ratios [OR] 0.74, 95% confidence interval 0.62 to 0.88; p = 0.0007) and the incidence of major bleeding was twofold higher (OR 2.01, 1.35 to 3.01; p = 0.0006). Metaregression indicated a positive correlation between prevention of recurrent stroke by DAPT and baseline stroke severity (p = 0.019), baseline risk profile (p = 0.0001), or prevalence of carotid atherosclerosis (p = 0.040). DAPT was more effective when initiated ≤7 days (OR 0.67, 0.58 to 0.77; p < 0.00001) and used for ≤3 months (OR 0.66, 0.58 to 0.76; p < 0.00001) after the event. In conclusion, in patients with stroke or TIA, the highest benefit of DAPT was observed in patients with higher baseline risk profile, greater stroke severity, or concomitant carotid disease, and when DAPT was initiated early and given for ≤3 months.

Long-Term Prognosis and Outcome Predictors in Takotsubo Syndrome: A Systematic Review and Meta-Regression Study.

OBJECTIVES: This study assessed the incidence of long-term adverse outcomes in patients with Takotsubo syndrome (TTS). BACKGROUND: The long-term prognosis of TTS is controversial. It is also unclear whether presenting characteristics are associated with the subsequent long-term prognosis. METHODS: We searched the PubMed, Embase, and Cochrane databases and reviewed cited references up to March 31, 2018, to identify studies with >6 months of follow-up data. RESULTS: Overall, we selected 54 studies that included a total of 4,679 patients (4,077 women and 602 men). Death during admission occurred in 112 patients (2.4%), yielding a frequency of 1.8% (95% confidence interval [CI]: 1.2% to 2.5%), with significant heterogeneity (I2 = 78%; p < 0.001). During a median follow-up of 28 months (interquartile range: 23 to 34 months), 464 of 4,567 patients who the survived index admission died (103 because of cardiac causes and 351 because of noncardiac issues). The annual rate of total mortality was 3.5% (95% CI: 2.6% to 4.5%), with significant heterogeneity (I2 = 74%; p < 0.001). Overall, 104 cases of recurrence of TTS were detected during follow-up, yielding a 1.0% annual rate of recurrence (95% CI: 0.7% to 1.3%), without significant heterogeneity (I2 = 39%; p = 0.898). Meta-regression analysis showed that long-term total mortality in each study was significantly associated with older age (p = 0.05), physical stressor (p = 0.0001), and the atypical ballooning form of TTS (p = 0.009). CONCLUSIONS: Our update analysis of patients discharged alive after TTS showed that long-term rates of overall mortality and recurrence were not trivial, and that some presenting features (older age, physical stressor, and atypical ballooning) were significantly associated with an unfavorable long-term prognosis.