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1.
Artigo em Inglês | MEDLINE | ID: mdl-31585830

RESUMO

BACKGROUND: Data are scarce regarding left atrial (LA) adaptation to regular physical exercise. The aim of this study was to examine left ventricular (LV) and also LA morphologic and functional remodeling in elite athletes using three-dimensional (3D) echocardiography. METHODS: In this retrospective analysis, the study group consisted of 138 elite athletes (mean age, 20 ± 4 years; 62% men) and 50 sedentary control subjects. Electrocardiographically gated full-volume 3D data sets were obtained for offline analysis using dedicated software for 3D LA and LV measurements. Body surface area-indexed LA maximal volume (LAVmax) and LV end-diastolic volume were determined. LA total emptying fraction, LA passive and LA active emptying fraction, and LV global longitudinal strain were also calculated. Athletes also underwent cardiopulmonary exercise testing to determine peak oxygen uptake. RESULTS: Athletes demonstrated higher 3D LAVmax (32 ± 6 vs 26 ± 8 mL/m2) and indexed LV end-diastolic volume (85 ± 12 vs 62 ± 10 mL/m2) compared with control subjects (P < .001 for both). Functional measures of the left ventricle and left atrium, such as the absolute value of 3D LV global longitudinal strain (19 ± 2% vs 22 ± 2%), LA total emptying fraction (58 ± 6% vs 64 ± 6%), and active emptying fraction (24 ± 10% vs 32 ± 10%) were lower in athletes (P < .001 for all). Male athletes had higher indexed LV end-diastolic volume compared with female athletes (89 ± 13 vs 80 ± 8 mL/m2, P < .001), but LAVmax did not differ between genders (32 ± 6 vs 33 ± 5 mL/m2, P = .18). Besides heart rate, gender, and body surface area, 3D LAVmax, LV global longitudinal strain, and LA passive emptying fraction were independent predictors of peak oxygen uptake. CONCLUSIONS: Regular physical exercise results in marked LA and LV remodeling with considerable gender differences as explored by 3D echocardiography. In contrast with various cardiovascular diseases, more pronounced LA dilation and lower resting functional measures are associated with better exercise performance.

2.
Diabetes Care ; 2019 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-31645407

RESUMO

OBJECTIVE: Diabetes increases the risk of all-cause mortality and sudden cardiac death (SCD). The exact mechanisms leading to sudden death in diabetes are not well known. We compared the incidence of appropriate shocks and mortality in patients with versus without diabetes with a prophylactic implantable cardioverter defibrillator (ICD) included in the retrospective EU-CERT-ICD registry. RESEARCH DESIGN AND METHODS AND RESULTS: A total of 3,535 patients from 12 European EU-CERT-ICD centers with a mean age of 63.7 ± 11.2 years (82% males) at the time of ICD implantation were included in the analysis. A total of 995 patients (28%) had a history of diabetes. All patients had an ICD implanted for primary SCD prevention. End points were appropriate shock and all-cause mortality. Mean follow-up time was 3.2 ± 2.3 years. Diabetes was associated with a lower risk of appropriate shocks (adjusted hazard ratio [HR] 0.77 [95% CI 0.62-0.96], P = 0.02). However, patients with diabetes had significantly higher mortality (adjusted HR 1.30 [95% CI 1.11-1.53], P = 0.001). CONCLUSIONS: All-cause mortality is higher in patients with diabetes than in patients without diabetes with primary prophylactic ICDs. Subsequently, patients with diabetes have a lower incidence of appropriate ICD shocks, indicating that the excess mortality might not be caused primarily by ventricular tachyarrhythmias. These findings suggest a limitation of the potential of prophylactic ICD therapy to improve survival in patients with diabetes with impaired left ventricular function.

3.
Europace ; 2019 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-31617896

RESUMO

AIMS: While improvement in quality of life (QoL) has been widely reported in cardiac resynchronization therapy (CRT) patients, its predictive value is not well-understood. We aimed to assess the predictive role of baseline QoL on long-term heart failure (HF) or death events in mild HF patients enrolled in Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). METHODS AND RESULTS: A total of 1791 of 1820 patients had their QoL evaluated at baseline, using the EuroQol-5 dimensions (EQ-5D) and the Kansas City Cardiomyopathy Questionnaires (KCCQ). Kaplan-Meier survival analyses and multivariate Cox models were utilized. Issues within any of the domains of the baseline EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were associated with long-term mortality (median follow-up 5.6 years) (all P < 0.05). Heart failure or death events were predicted by issues in baseline mobility [hazard ratio (HR) = 1.41, P < 0.001], usual activities (HR = 1.41, P < 0.001), and anxiety/depression (HR = 1.21, P = 0.035). The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003). Every 10% increase in the visual analogue scale (0-100) was associated with an 8% lower risk of all-cause mortality (P = 0.006), and a 6% lower risk of HF/death (P = 0.002). Mobility issues also predicted echocardiographic reverse remodelling (-33.08 mL vs. -31.17 mL, P = 0.043). Using the KCCQ, patients in the lower tertile of the clinical summary or physical limitations score had a significantly higher risk of long-term HF or death (P < 0.05). CONCLUSION: In mild HF patients enrolled in MADIT-CRT, multiple baseline QoL questionnaire domains were predictors of echocardiographic remodelling, long-term all-cause mortality, and HF events.

5.
Artigo em Inglês | MEDLINE | ID: mdl-31665257

RESUMO

AIMS: Cardiac CT is increasingly applied for planning and follow-up of transcatheter aortic valve implantation (TAVI). However, there are no data available on reverse remodelling after TAVI assessed by CT. Therefore, we aimed to evaluate the predictors and the prognostic value of left ventricular (LV) reverse remodelling following TAVI using CT angiography. METHODS AND RESULTS: We investigated 117 patients with severe, symptomatic aortic stenosis (AS) who underwent CT scanning before and after TAVI procedure with a mean follow-up time of 2.6 years after TAVI. We found a significant reduction in LV mass (LVM) and LVM indexed to body surface area comparing pre- vs. post-TAVI images: 180.5 ± 53.0 vs. 137.1 ± 44.8 g and 99.7 ± 25.4 vs. 75.4 ± 19.9 g/m2, respectively, both P < 0.001. Subclinical leaflet thrombosis (SLT) was detected in 25.6% (30/117) patients. More than 20% reduction in LVM was defined as reverse remodelling and was detected in 62.4% (73/117) of the patients. SLT, change in mean pressure gradient on echocardiography and prior myocardial infarction was independently associated with LV reverse remodelling after adjusting for age, gender, and traditional risk factors (hypertension, body mass index, diabetes mellitus, and hyperlipidaemia): OR = 0.27, P = 0.022 for SLT and OR = 0.22, P = 0.006 for prior myocardial infarction, OR = 1.51, P = 0.004 for 10 mmHg change in mean pressure gradient. Reverse remodelling was independently associated with favourable outcomes (HR = 0.23; P = 0.019). CONCLUSION: TAVI resulted in a significant LVM regression on CT. The presence of SLT showed an inverse association with LV reverse remodelling and thus it may hinder the beneficial LV structural changes. Reverse remodelling was associated with improved long-term prognosis.

6.
Cardiol J ; 2019 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-31489962

RESUMO

BACKGROUND: Heart rate (HR), mean arterial pressure (MAP) and carotid intima-media thickness (cIMT) are moderately heritable cardiovascular traits, but the environmental effects on the longitudinal change of their heritability have never been investigated. METHODS: 368 Italian and Hungarian twins (107 monozygotic, 77 dizygotic) underwent oscillometric measurement and B-mode sonography of bilateral carotid arteries in 2009/10 and 2014. Within-individual/cross-study wave, cross-twin/within-study wave and cross-twin/cross-study wave correlations were estimated, and bivariate Cholesky models were fitted to decompose the total variance at each wave and covariance between study waves into additive genetic, shared and unique environmental components. RESULTS: For each trait, a moderate longitudinal stability was observed, with within-individual/cross-wave correlations of 0.42 (95% CI: 0.33-0.51) for HR, 0.34 (95% CI: 0.24-0.43) for MAP, and 0.23 (95% CI: 0.12-0.33) for cIMT. Cross-twin/cross-wave correlations in monozygotic pairs were all significant and substantially higher than the corresponding dizygotic correlations. Genetic continuity was the main source of longitudinal stability, with across-time genetic correlations of 0.52 (95% CI: 0.29-0.71) for HR, 0.56 (95% CI: 0.31-0.81) for MAP, and 0.36 (95% CI: 0.07-0.64) for cIMT. Overlapping genetic factors explained respectively 57%, 77%, and 68% of the longitudinal covariance of the HR, MAP and cIMT traits. CONCLUSIONS: Genetic factors have a substantial role in the longitudinal change of HR, MAP and cIMT; however, the influence of unique environmental factors remains relevant. Further studies should better elucidate whether epigenetic mechanisms have a role in influencing the stability of the investigated traits over time.

7.
JACC Heart Fail ; 7(10): 878-887, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31521682

RESUMO

OBJECTIVES: The authors investigated the impact of coronary artery bypass grafting (CABG) on first and recurrent hospitalization in this population. BACKGROUND: In the STICH (Surgical Treatment for Ischemic Heart Failure) trial, CABG reduced all-cause death and hospitalization in patients with and ischemic cardiomyopathy and left ventricular ejection fraction <35%. METHODS: A total of 1,212 patients were randomized (610 to CABG + optimal medical therapy [CABG] and 602 to optimal medical therapy alone [MED] alone) and followed for a median of 9.8 years. All-cause and cause-specific hospitalizations were analyzed as time-to-first-event and as recurrent event analysis. RESULTS: Of the 1,212 patients, 757 died (62.4%) and 732 (60.4%) were hospitalized at least once, for a total of 2,549 total all-cause hospitalizations. Most hospitalizations (66.2%) were for cardiovascular causes, of which approximately one-half (907 or 52.9%) were for heart failure. More than 70% of all hospitalizations (1,817 or 71.3%) were recurrent events. The CABG group experienced fewer all-cause hospitalizations in the time-to-first-event (349 CABG vs. 383 MED, adjusted hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.74 to 0.98; p = 0.03) and in recurrent event analyses (1,199 CABG vs. 1,350 MED, HR: 0.78, 95% CI: 0.65 to 0.94; p < 0.001). This was driven by fewer total cardiovascular (CV) hospitalizations (744 vs. 968; p < 0.001, adjusted HR: 0.66, 95% CI: 0.55 to 0.81; p = 0.001), the majority of which were due to HF (395 vs. 512; p < 0.001, adjusted HR: 0.68, 95% CI: 0.52-0.89; p = 0.005). We did not observe a difference in non-CV events. CONCLUSIONS: CABG reduces all-cause, CV, and HF hospitalizations in time-to-first-event and recurrent event analyses. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease [STICH]; NCT00023595).

8.
N Engl J Med ; 2019 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-31562798

RESUMO

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

9.
J Electrocardiol ; 2019 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-31526572

RESUMO

BACKGROUND: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. It is urgently needed to better identify patients who benefit from prophylactic ICD therapy. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) completed in 2019 will assess this issue. SUMMARY: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicenter observational cohort study done in 44 centers across 15 European countries. A total of 2327 patients with heart failure due to ischemic heart disease or dilated cardiomyopathy indicated for primary prophylactic ICD implantation were recruited between 2014 and 2018 (>1500 patients at first ICD implantation, >750 patients non-randomized non-ICD control group). The primary endpoint was all-cause mortality, and first appropriate shock was co-primary endpoint. At baseline, all patients underwent 12­lead ECG and Holter-ECG analysis using multiple advanced methods for risk stratification as well as documentation of clinical characteristics and laboratory values. The EU-CERT-ICD data will provide much needed information on the survival benefit of preventive ICD therapy and expand on previous prospective risk stratification studies which showed very good applicability of clinical parameters and advanced risk stratifiers in order to define patient subgroups with above or below average ICD benefit. CONCLUSION: The EU-CERT-ICD study will provide new and current data about effectiveness of primary prophylactic ICD implantation. The study also aims for improved risk stratification and patient selection using clinical risk markers in general, and advanced ECG risk markers in particular.

10.
Circulation ; 2019 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-31557056

RESUMO

Background: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation (AF) who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. Methods: Using a 2×2 factorial design we compared apixaban with vitamin K antagonists (VKA) and aspirin with placebo in patients with AF who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death, and hospitalization as well as death and ischemic events by antithrombotic strategy in three pre-specified subgroups: patients with ACS treated medically, ACS treated with PCI, and those undergoing elective PCI. Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with VKA reduced ISTH major or CRNM bleeding in patients with ACS treated medically (HR 0.44, 95% CI 0.28-0.68), ACS treated with PCI (HR 0.68, 95% CI 0.52-0.89), and undergoing elective PCI (HR 0.82, 95% CI 0.64-1.04) (pinteraction=0.052); and reduced death or hospitalization in ACS treated medically (HR 0.71, 95% CI 0.54-0.92), ACS treated with PCI (HR 0.88, 95% CI 0.74-1.06), and elective PCI (HR 0.87, 95% CI 0.72-1.04) (pinteraction=0.345). Compared with VKA, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (pinteraction=0.356). Compared with placebo, aspirin had a higher rate of bleeding than placebo in patients with ACS treated medically (HR 1.49, 95% CI 0.98-2.26), ACS treated with PCI (HR 2.02, 95% CI 1.53-2.67) and elective PCI groups (HR 1.91, 95% CI 1.48-2.47) (pinteraction=0.479). For the same comparison, there was no difference in outcomes among the three groups for the composite of death or hospitalization (pinteraction=0.787) and death and ischemic events (pinteraction=0.710). Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with AF who have ACS, whether managed medically or with PCI, or those undergoing elective PCI than regimens that include VKAs, aspirin, or both. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02415400.

11.
N Engl J Med ; 2019 Sep 19.
Artigo em Inglês | MEDLINE | ID: mdl-31535829

RESUMO

BACKGROUND: In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes. METHODS: In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death. RESULTS: Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups. CONCLUSIONS: Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.).

12.
Lancet ; 394(10206): 1344-1351, 2019 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-31488371

RESUMO

BACKGROUND: A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality. METHODS: We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (≤35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality. FINDINGS: Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2·7 years [IQR 2·0-3·3] in the ICD group and 1·2 years [0·8-2·7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0·57 [95% CI 0·41-0·79]; p=0·0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0·0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7·5 deg or higher (n=199; adjusted HR 0·25 [95% CI 0·13-0·47] for the ICD group vs the control group; p<0·0001) than in those with periodic repolarisation dynamics less than 7·5 deg (n=1166; adjusted HR 0·69 [95% CI 0·47-1·00]; p=0·0492; pinteraction=0·0056). The number needed to treat was 18·3 (95% CI 10·6-4895·3) in patients with periodic repolarisation dynamics less than 7·5 deg and 3·1 (2·6-4·8) in those with periodic repolarisation dynamics of 7·5 deg or higher. INTERPRETATION: Periodic repolarisation dynamics predict mortality reductions associated with prophylactic implantation of ICDs in contemporarily treated patients with ischaemic or non-ischaemic cardiomyopathy. Periodic repolarisation dynamics could help to guide treatment decisions about prophylactic ICD implantation. FUNDING: The European Community's 7th Framework Programme.


Assuntos
Arritmias Cardíacas/mortalidade , Arritmias Cardíacas/prevenção & controle , Cardiomiopatias/terapia , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Cardioversão Elétrica , Idoso , Cardiomiopatias/complicações , Cardiomiopatias/mortalidade , Estudos de Coortes , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Volume Sistólico
13.
N Engl J Med ; 381(17): 1609-1620, 2019 10 24.
Artigo em Inglês | MEDLINE | ID: mdl-31475794

RESUMO

BACKGROUND: The angiotensin receptor-neprilysin inhibitor sacubitril-valsartan led to a reduced risk of hospitalization for heart failure or death from cardiovascular causes among patients with heart failure and reduced ejection fraction. The effect of angiotensin receptor-neprilysin inhibition in patients with heart failure with preserved ejection fraction is unclear. METHODS: We randomly assigned 4822 patients with New York Heart Association (NYHA) class II to IV heart failure, ejection fraction of 45% or higher, elevated level of natriuretic peptides, and structural heart disease to receive sacubitril-valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily) or valsartan (target dose, 160 mg twice daily). The primary outcome was a composite of total hospitalizations for heart failure and death from cardiovascular causes. Primary outcome components, secondary outcomes (including NYHA class change, worsening renal function, and change in Kansas City Cardiomyopathy Questionnaire [KCCQ] clinical summary score [scale, 0 to 100, with higher scores indicating fewer symptoms and physical limitations]), and safety were also assessed. RESULTS: There were 894 primary events in 526 patients in the sacubitril-valsartan group and 1009 primary events in 557 patients in the valsartan group (rate ratio, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P = 0.06). The incidence of death from cardiovascular causes was 8.5% in the sacubitril-valsartan group and 8.9% in the valsartan group (hazard ratio, 0.95; 95% CI, 0.79 to 1.16); there were 690 and 797 total hospitalizations for heart failure, respectively (rate ratio, 0.85; 95% CI, 0.72 to 1.00). NYHA class improved in 15.0% of the patients in the sacubitril-valsartan group and in 12.6% of those in the valsartan group (odds ratio, 1.45; 95% CI, 1.13 to 1.86); renal function worsened in 1.4% and 2.7%, respectively (hazard ratio, 0.50; 95% CI, 0.33 to 0.77). The mean change in the KCCQ clinical summary score at 8 months was 1.0 point (95% CI, 0.0 to 2.1) higher in the sacubitril-valsartan group. Patients in the sacubitril-valsartan group had a higher incidence of hypotension and angioedema and a lower incidence of hyperkalemia. Among 12 prespecified subgroups, there was suggestion of heterogeneity with possible benefit with sacubitril-valsartan in patients with lower ejection fraction and in women. CONCLUSIONS: Sacubitril-valsartan did not result in a significantly lower rate of total hospitalizations for heart failure and death from cardiovascular causes among patients with heart failure and an ejection fraction of 45% or higher. (Funded by Novartis; PARAGON-HF ClinicalTrials.gov number, NCT01920711.).

15.
Eur J Prev Cardiol ; : 2047487319866019, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31370686

RESUMO

AIMS: Physiological cardiac adaptation in athletes is influenced by multiple factors. This study aimed to investigate the impact of sex, age, body size, sports type and training volume on cardiac adaptation in healthy athletes with cardiac magnetic resonance imaging. METHODS: A total of 327 athletes (242 male) were studied (adults ≥18 years old; adolescents 14-18 years old). Left and right ventricular ejection fractions, end-diastolic volume, end-systolic volume, stroke volumes and masses were measured. Left ventricular end-diastolic volume/left ventricular mass, right ventricular end-diastolic volume/right ventricular mass and derived right/left ventricular ratios were determined to study balanced ventricular adaptation. Athletes were categorised as skill, power, mixed and endurance athletes. RESULTS: Male athletes had higher left and right ventricular volumes and masses in both adult (n = 215 (145 male); 24 ± 5 years old) and adolescent (n = 112 (97 male); 16 ± 1 years old) groups compared with women (all P < 0.05). In adults, male sex, age, body surface area, weekly training hours, mixed and endurance sports correlated with higher ventricular volumes and masses (all P < 0.05); and a combination of age, sex, training hours, endurance and mixed sports explained 30% of the variance of the left ventricular end-diastolic volume index (r = 0.30), right ventricular end-diastolic volume index (r = 0.34), right ventricular mass index (r = 0.30); and as much as 53% of the left ventricular mass index (r = 0.53) (all P < 0.0001). In adolescents, positive correlations were found between training hours and left ventricular hypertrophy (r = 0.39, P < 0.0001), and biventricular dilation (left ventricular end-diastolic volume r = 0.34, P = 0.0008; right ventricular end-diastolic volume r = 0.36, P = 0.0004). In adolescents, age and body surface area did not correlate with cardiac magnetic resonance parameters. CONCLUSION: There are significant sex differences in the physiological adaptation of adult and adolescent athlete's heart; and male sex, higher training volume and endurance sports are major determinants of sports adaptation in adults.

16.
Europace ; 2019 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-31436835

RESUMO

AIMS: ENSURE-AF (NCT02072434) was the largest prospective randomized clinical trial of anticoagulation for cardioversion in atrial fibrillation (AF), which also provides the largest prospective dataset for transoesophageal echocardiography (TOE) prior to cardioversion. This ancillary analysis investigated determinants of TOE-detected left atrium thrombi (LAT) in patients scheduled for electrical cardioversion (ECV). METHODS AND RESULTS: The ENSURE-AF multicentre PROBE evaluation trial compared edoxaban 60 mg once daily (QD) with enoxaparin/warfarin in 2199 subjects undergoing ECV of non-valvular AF. Patients were stratified by the use of TOE, anticoagulant experience, and selected edoxaban dose. Electrical cardioversion was cancelled or deferred when TOEdetected LAT. In total, 1183 subjects were stratified to the TOE arm and LAT was reported in 91 (8.2%). In univariate analysis, age ≥75 years (26.4% vs. 16.9%, P = 0.0308), lower weight (86.5 ± 15.0 vs. 90.7 ± 18.0 kg, P = 0.0309), lower creatinine clearance (80.1 ± 30.6 vs. 93.2 ± 33.9 mL/min, P = 0.0007), heart failure (59.3% vs. 43.0%, P = 0.0029), and diuretic treatment (53.9% vs. 40.1%, P = 0.0141) were more prevalent in the LAT group. Non-significant trends were seen for higher mean CHA2DS2-VASc score (3.0 ± 1.41 vs. 2.7 ± 1.48, P = 0.0571) and more prevalent anticoagulation use prior to enrolment (60.4% vs. 50.3%, P = 0.0795) in the LAT group. In logistic regression analysis, age (P = 0.0202) and heart failure (P = 0.0064) were independently associated with LAT. CONCLUSION: Elective ECV is commonly cancelled or deferred due to TOE-detected LAT in patients with non-valvular AF. Age ≥75 years and heart failure were associated with the presence of LAT.

18.
N Engl J Med ; 381(8): 716-726, 2019 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-31433919

RESUMO

BACKGROUND: Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure. METHODS: In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 µg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days. RESULTS: A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P = 0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P = 0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups. CONCLUSIONS: In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.).


Assuntos
Doenças Cardiovasculares/mortalidade , Insuficiência Cardíaca/tratamento farmacológico , Relaxina/uso terapêutico , Vasodilatadores/uso terapêutico , Doença Aguda , Idoso , Pressão Sanguínea/efeitos dos fármacos , Progressão da Doença , Método Duplo-Cego , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Hospitalização , Humanos , Incidência , Infusões Intravenosas , Masculino , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/farmacologia , Proteínas Recombinantes/uso terapêutico , Relaxina/efeitos adversos , Relaxina/farmacologia , Falha de Tratamento , Vasodilatadores/efeitos adversos
19.
Europace ; 21(10): 1459-1467, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31377792

RESUMO

Self-terminating atrial arrhythmias are commonly detected on continuous rhythm monitoring, e.g. by pacemakers or defibrillators. It is unclear whether the presence of these arrhythmias has therapeutic consequences. We sought to summarize evidence on the prevalence of atrial high-rate episodes (AHREs) and their impact on risk of stroke. We performed a comprehensive, tabulated review of published literature on the prevalence of AHRE. In patients with AHRE, but without atrial fibrillation (AF), we reviewed the stroke risk and the potential risk/benefit of oral anticoagulation. Atrial high-rate episodes are found in 10-30% of AF-free patients. Presence of AHRE slightly increases stroke risk (0.8% to 1%/year) compared with patients without AHRE. Atrial high-rate episode of longer duration (e.g. those >24 h) could be associated with a higher stroke risk. Oral anticoagulation has the potential to reduce stroke risk in patients with AHRE but is associated with a rate of major bleeding of 2%/year. Oral anticoagulation is not effective in patients with heart failure or survivors of a stroke without AF. It remains unclear whether anticoagulation is effective and safe in patients with AHRE. Atrial high-rate episodes are common and confer a slight increase in stroke risk. There is true equipoise on the best way to reduce stroke risk in patients with AHRE. Two ongoing trials (NOAH-AFNET 6 and ARTESiA) will provide much-needed information on the effectiveness and safety of oral anticoagulation using non-vitamin K antagonist oral anticoagulants in patients with AHRE.

20.
Radiology ; 293(1): 89-96, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31385755

RESUMO

Background Visual and histogram-based assessments of coronary CT angiography have limited accuracy in the identification of advanced lesions. Radiomics-based machine learning (ML) could provide a more accurate tool. Purpose To compare the diagnostic performance of radiomics-based ML with that of visual and histogram-based assessment of ex vivo coronary CT angiography cross sections to identify advanced atherosclerotic lesions defined with histologic examination. Materials and Methods In this prospective study, 21 coronary arteries from seven hearts obtained from male donors (mean age, 52.3 years ± 5.3) were imaged ex vivo with coronary CT angiography between February 23, 2009, and July 31, 2010. From 95 coronary plaques, 611 histologic cross sections were coregistered with coronary CT cross sections. Lesions were considered advanced if early fibroatheroma, late fibroatheroma, or thin-cap atheroma was present. CT cross sections were classified as showing homogeneous, heterogeneous, or napkin-ring sign plaques on the basis of visual assessment. The area of low attenuation (<30 HU) and the average Hounsfield unit were quantified. Radiomic parameters were extracted and used as inputs to ML algorithms. Eight radiomics-based ML models were trained on randomly selected cross sections (training set, 75% of the cross sections) to identify advanced lesions. Visual assessment, histogram-based assessment, and the best ML model were compared on the remaining 25% of the data (validation set) by using the area under the receiver operating characteristic curve (AUC) to identify advanced lesions. Results After excluding sections with no visible plaque (n = 134) and with heavy calcium (n = 32), 445 cross sections were analyzed. Of those 445 cross sections, 134 (30.1%) were advanced lesions. Visual assessment of the 445 cross sections indicated that 207 (46.5%) were homogeneous, 200 (44.9%) were heterogeneous, and 38 (8.5%) demonstrated the napkin-ring sign. A radiomics-based ML model incorporating 13 parameters outperformed visual assessment (AUC = 0.73 with 95% confidence interval [CI] of 0.63, 0.84 vs 0.65 with 95% CI of 0.56, 0.73, respectively; P = .04), area of low attenuation (AUC = 0.55 with 95% CI of 0.42, 0.68; P = .01), and average Hounsfield unit (AUC = 0.53 with 95% CI of 0.42, 0.65; P = .004) in the identification of advanced atheromatous lesions. Conclusion Radiomics-based machine learning analysis improves the discriminatory power of coronary CT angiography in the identification of advanced atherosclerotic lesions. Published under a CC BY 4.0 license.

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