Adaptive servo‐ventilation for central sleep apnoea in systolic heart failure: results of the major substudy of SERVE‐HF

Aims

The SERVE‐HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo‐ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers.

Methods and results

In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12‐month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between‐group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N‐terminal pro B‐type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between‐group differences in changes in cardiac, renal and systemic inflammation biomarkers.

Conclusion

In patients with systolic heart failure and CSA, addition of ASV to guideline‐based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE‐HF may not be related to adverse remodelling or worsening heart failure.

     

Relation between electrical and mechanical dyssynchrony in patients with left bundle branch block: An electro‐ and vectorcardiographic study

Background

Current guidelines select patients for cardiac resynchronization therapy (CRT) mainly on electrocardiographic parameters like QRS duration and left bundle branch block (LBBB). However, among those LBBB patients, heterogeneity in mechanical dyssynchrony occurs and might be a reason for nonresponse to CRT. This study assesses the relation between electrocardiographic characteristics and presence of mechanical dyssynchrony among LBBB patients.

Methods

The study included patients with true LBBB (including mid‐QRS notching) on standard 12‐lead electrocardiograms. Left bundle branch block‐induced mechanical dyssynchrony was assessed by the presence of septal flash on two‐dimensional echocardiography. Previously reported electro‐ and vectorcardiographic dyssynchrony markers were analyzed: global QRS duration (QRSD_LBBB), left ventricular activation time (QRSD_LVAT), time to intrinsicoid deflection (QRSD_ID), and vectorcardiographic QRS areas in the 3D vector loop (QRSA_3D).

Results

The study enrolled 545 LBBB patients. Septal flash (SF) is present in 52% of patients presenting with true LBBB. Patients with SF are more frequent female, have less ischemic heart disease and smaller left ventricular dimensions. In multivariate analysis longer QRSD_LBBB, QRSD_LVAT and larger QRSA_3D were independently associated with SF. Of all parameters, QRSA_3D has the best accuracy to predict SF, although overall accuracy remains moderate (59% sensitivity, 58% specificity). The predictive value of QRSA_3D remained constant in both sexes, irrespective of ischemic heart disease, ejection fraction and even when categorizing for QRSD_LBBB.

Conclusion

In LBBB patients, large QRS areas correlate better with mechanical dyssynchrony compared to wide QRSD intervals. However, the overall accuracy to predict mechanical dyssynchrony by electrocardiographic dyssynchrony markers, even when using complex vectorcardiographic parameters, remains low.

     

Bypassing the Emergency Room to Reduce Door‐to‐Balloon Time and Improve Outcomes of ST Elevation Myocardial Infarction Patients: Analysis of Data from 2004–2010 ACSIS Registry

Objectives

Our objective was to assess whether bypassing the emergency room (ER) is associated with meaningful reduction in Major Adverse Cardiac and Cerebrovascular Event (MACCE) or mortality in a large cohort of ST Elevation Myocardial Infarction (STEMI) patients.

Background

Prior studies suggest that bypassing the emergency room reduces door‐to‐balloon time (DBT). However, it is not clear whether this translates into reduced mortality.

Methods

We analyzed data of 1,552 consecutive patients with STEMI treated by primary percutaneous coronary intervention (PCI) and enrolled in the Acute Coronary Syndrome Israeli Survey (ACSIS) registry. Thirty percent of patients (n = 459) arrived directly to the Intensive Cardiac Care Unit or catheterization laboratory and 70% (n = 1093) were assessed first in the ER. Our primary end points were DBT, 30‐day MACCE, and 30‐day and 1‐year mortality. Our secondary end points were pre‐discharge ejection fraction less than 40%, in‐hospital pulmonary edema, in‐hospital cardiogenic shock, ST resolution, and duration of hospitalization.

Results

Bypassing the ER was associated with signficantly shorter DBT (59 vs. 97 minutes, P = 0.001). There was no difference in 30‐day MACCE and 30‐day or 1‐year mortality between the 2 study groups. The findings were consistent in multiple subgroups, including women, anterior STEMI, off hours PCI, and patients with pain‐to‐door (PDT) time of less than 120 minutes.

Conclusion

Bypassing the ER is associated with significant shortening of DBT. This reduction, however, is not associated with any change in 30‐day MACCE and 30‐day or 1‐year mortality.

     

Screening for human papillomavirus,cervical cytological abnormalities and associated risk factors in HIV‐positive and HIV‐negative women in Rwanda

Objectives

Cervical cancer is the major cause of death from cancer in Africa. We wanted to assess the prevalence of human papillomavirus (HPV) infections and associated risk factors and to determine whether HPV testing could serve as a screening method for squamous intraepithelial lesions (SILs) in Rwanda. We also wanted to obtain a broader understanding of the underlying risk factors for the establishment of HPV infection in Rwanda.

Methods

A total of 206 HIV‐positive women, 172 HIV‐negative women and 22 women with unknown HIV status were recruited at the University Teaching Hospitals of Kigali (UTHK) and of Butare (UTHB) in Rwanda. Participants underwent an interview, cervical sampling for a Thinprep Pap test and a screening test analysing 37 HPV strains.

Results

Only 27% of HIV‐positive women and 7% of HIV‐negative women had been screened for cervical cancer before. HPV16 and HPV52 were the most common HPV strains. HIV‐positive women were more commonly infected with high‐risk (HR) HPV and multitype HPV than HIV‐negative women. The sensitivity was 78% and the specificity 87% to detect high‐grade SIL (HSIL) with HPV screening. Among HIV‐negative women, being divorced was positively associated with HR‐HPV infection, while hepatitis B, Trichomonas vaginalis infection and HR‐HPV infection were factors positively associated with SILs. Ever having had gonorrhoea was positively associated with HR‐HPV infection among HIV‐positive women. HR‐HPV infection and the number of live births were positively associated with SILs.

Conclusions

The currently used quadrivalent vaccine may be insufficient to give satisfactory HPV coverage in Rwanda. HPV Screening may be effective to identify women at risk of developing cervical cancer, particularly if provided to high‐risk patients.

     

Baseline fragmented QRS increases the risk of major arrhythmic events in hypertrophic cardiomyopathy: Systematic review and meta‐analysis

Background

Fragmented QRS reflects disturbances in the myocardium predisposing the heart to ventricular tachyarrhythmias. Recent studies suggest that fragmented QRS (fQRS) is associated with worse major arrhythmic events in hypertrophic cardiomyopathy (HCM). However, a systematic review and meta‐analysis of the literature has not been done. We assessed the association between fQRS and major arrhythmic events in hypertrophic cardiomyopathy by a systematic review of the literature and a meta‐analysis.

Methods

We comprehensively searched the databases of MEDLINE and EMBASE from inception to May 2017. Included studies were published prospective or retrospective cohort studies that compared major arrhythmic events (sustained ventricular tachycardia, sudden cardiac arrest, or sudden cardiac death) in HCM with fQRS versus non‐fQRS. Data from each study were combined using the random‐effects, generic inverse variance method of DerSimonian and Laird to calculate risk ratios and 95% confidence intervals.

Results

Five studies from January 2013 to May 2017 were included in this meta‐analysis involving 673 subjects with HCM (205 fQRS and 468 non‐fQRS). Fragmented QRS was associated with major arrhythmic events (pooled risk ratio = 7.29, 95% confidence interval: 4.00–13.29, p < .01, I² = 0%).

Conclusion

Baseline fQRS increased major arrhythmic events up to sevenfold. Our study suggests that fQRS could be an important tool for risk assessment in patients with HCM.

     

Narrowing filtered QRS duration on signal‐averaged electrocardiogram predicts outcomes in cardiac resynchronization therapy patients with nonischemic heart failure

Background

To evaluate the impact of changes in the filtered QRS duration (fQRS) on signal‐averaged electrocardiograms (SAECGs) from pre‐ to postimplantation on the clinical outcomes in nonischemic heart failure (HF) patients under cardiac resynchronization therapy (CRT).

Methods

We studied 103 patients with nonischemic HF and sinus rhythm who underwent CRT implantation. SAECGs were obtained within 1 week before and 1 week after implantation and narrowing fQRS was defined as a decrease in fQRS from pre‐ to postimplantation. Echocardiography was performed before and 6 months after CRT implantation. The primary outcome was death from any cause. The secondary outcomes were hospitalization due to worsened HF and occurrence of ventricular tachyarrhythmias.

Results

Of the 103 CRT patients, 53 (51%) showed narrowing fQRS. Left ventricular end‐diastolic volume and end‐systolic volume were significantly reduced (both p < .001), and the left ventricular ejection fraction was significantly increased (p < .001) after CRT in patients with narrowing fQRS, but not in patients with nonnarrowing fQRS. During a median follow‐up period of 33 months, patients with narrowing fQRS exhibited better survival than patients with nonnarrowing fQRS (p = .007). A lower incidence of hospitalization due to worsened HF (p < .001) and a lower occurrence of ventricular tachyarrhythmias (p = .071) were obtained in patients with narrowing fQRS. After adjusting for confounding variables, narrowing fQRS was associated with a low risk of mortality (HR 0.27, p = .006).

Conclusion

Our results suggested that narrowing fQRS on SAECG after CRT implantation predicts LV reverse remodeling and long‐term outcomes in nonischemic HF patients.

     

Association between mean systolic and diastolic blood pressure throughout the follow‐up and cardiovascular events in acute myocardial infarction patients with systolic dysfunction and/or heart failure: an analysis from the High‐Risk Myocardial Infarction Database Initiative

Background

Observational data have described the association of blood pressure (BP) with mortality as ‘J‐shaped’, meaning that mortality rates increase below a certain BP threshold. We aimed to analyse the associations between BP and prognosis in a population of acute myocardial infarction (MI) patients with heart failure (HF) and/or systolic dysfunction.

Methods and results

The datasets included in this pooling initiative are derived from four trials: CAPRICORN, EPHESUS, OPTIMAAL, and VALIANT. A total of 28 771 patients were included in this analysis. Arithmetic means of all office BP values measured throughout follow‐up were used. The primary outcome was cardiovascular death. The mean age was 65 ± 11.5 years and 30% were female. Patients in the lower systolic BP (SBP) quintiles had higher rates of cardiovascular death (reference: SBP 121–128 mmHg) [adjusted hazard ratio (HR) 2.49, 95% confidence interval (CI) 2.26–2.74 for SBP ≤112 mmHg, and HR 1.29, 95% CI 1.16–1.43 for SBP 113–120 mmHg]. The findings for HF hospitalization and MI were similar. However, stroke rates were higher in patients within the highest SBP quintile (reference: SBP 121–128 mmHg) (HR 1.38, 95% CI 1.11–1.72). Patients who died had a much shorter follow‐up (0.7 vs. 2.1 years), less BP measurements (4.6 vs. 9.8) and lower mean BP (–8 mmHg in the last SBP measurement compared with patients who remained alive during the follow‐up), suggesting that the associations of low BP and increased cardiovascular death represent a reverse causality phenomenon.

Conclusion

Systolic BP values <125 mmHg were associated with increased cardiovascular death, but these findings likely represent a reverse causality phenomenon.

     

Baseline fragmented QRS increases the risk of major arrhythmic events in Brugada syndrome: Systematic review and meta‐analysis

Background

Fragmented QRS reflects disturbances in the myocardium predisposing the heart to ventricular tachyarrhythmias. Recent studies suggest that fragmented QRS (fQRS) is associated with major arrhythmic events in Brugada syndrome. However, a systematic review and meta‐analysis of the literature has not been done. We assessed the association between fQRS and major arrhythmic events in Brugada syndrome by a systematic review of the literature and a meta‐analysis.

Methods

We comprehensively searched the databases of MEDLINE and EMBASE from inception to May 2017. Included studies were published prospective or retrospective cohort studies that compared major arrhythmic events (ventricular fibrillation, sustained ventricular tachycardia, sudden cardiac arrest, or sudden cardiac death) in Brugada syndrome with fQRS versus normal QRS. Data from each study were combined using the random‐effects, generic inverse variance method of DerSimonian and Laird to calculate risk ratios and 95% confidence intervals.

Results

Nine studies from January 2012 to May 2017 were included in this meta‐analysis involving 2,360 subjects with Brugada syndrome (550 fQRS and 1,810 non‐fQRS). Fragmented QRS was associated with major arrhythmic events (pooled risk ratio =3.36, 95% confidence interval: 2.09‐5.38, p < .001, I² = 50.9%) as well as fatal arrhythmia (pooled risk ratio =3.09, 95% confidence interval: 1.40‐6.86, p = .005, I² = 69.7%).

Conclusions

Baseline fQRS increased major arrhythmic events up to 3‐fold. Our study suggests that fQRS could be an important tool for risk assessment in patients with Brugada syndrome.

     

Proteomic diversity of high‐density lipoprotein explains its association with clinical outcome in patients with heart failure

Aims

Previously, low high‐density lipoprotein (HDL) cholesterol was found to be one of the strongest predictors of mortality and/or heart failure (HF) hospitalisation in patients with HF. We therefore performed in‐depth investigation of the multifunctional HDL proteome to reveal underlying pathophysiological mechanisms explaining the association between HDL and clinical outcome.

Methods and results

We selected a cohort of 90 HF patients with 1:1 cardiovascular death/survivor ratio from BIOSTAT‐CHF. A novel optimised protocol for selective enrichment of lipoproteins was used to prepare plasma. Enriched lipoprotein content of samples was analysed using high resolution nanoscale liquid chromatography‐mass spectrometry‐based proteomics, utilising a label free approach. Within the HDL proteome, 49 proteins significantly differed between deaths and survivors. An optimised model of 12 proteins predicted death with 76% accuracy (Nagelkerke R²=0.37, P < 0.001). The strongest contributors to this model were filamin‐A (related to crosslinking of actin filaments) [odds ratio (OR) 0.31, 95% confidence interval (CI) 0.15–0.61, P = 0.001] and pulmonary surfactant‐associated protein B (related to alveolar capillary membrane function) (OR 2.50, 95% CI 1.57–3.98, P < 0.001). The model predicted mortality with an area under the curve of 0.82 (95% CI 0.77–0.87, P < 0.001). Internal cross validation resulted in 73.3 ± 7.2% accuracy.

Conclusion

This study shows marked differences in composition of the HDL proteome between HF survivors and deaths. The strongest differences were seen in proteins reflecting crosslinking of actin filaments and alveolar capillary membrane function, posing potential pathophysiological mechanisms underlying the association between HDL and clinical outcome in HF.

     

Direct comparison of ultrafiltration to pharmacological decongestion in heart failure: a per‐protocol analysis of CARRESS‐HF

Aims

Mechanical ultrafiltration (UF) involves the removal of an iso‐osmotic filtrate from the blood. Its benefit in acute decompensated heart failure, however, remains inconclusive. We sought to better understand the direct effects of UF in comparison to an aggressive, urine output‐guided pharmacological protocol for decongestion on fluid loss, renal function, and neurohormonal activation.

Methods and results

A per‐protocol analysis of the Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS‐HF) trial (n = 188) was performed. Participants were included if randomized to UF and had UF output collected, or if randomized to the pharmacological arm and had urine but not UF output collected. Using these definitions, there were 163 participants at 24 h, 156 at 48 h, 129 at 72 h, and 106 at 96 h. UF was associated with higher cumulative fluid loss (P = 0.003), net fluid loss (P = 0.001), and relative reduction in weight (P = 0.02). UF was also associated with higher serum creatinine and blood urea nitrogen by 72 h (P‐interaction <0.05 for both), lower serum sodium by 48 h (P‐interaction <0.01) and increased plasma renin activity by 96 h (P = 0.04). The pharmacological arm was associated with higher serum bicarbonate after 24 h (P‐interaction <0.002). There were no differences in 60‐day outcomes between the UF and pharmacological arms.

Conclusions

Ultrafiltration vs. pharmacological therapy was associated with more fluid removal but also rise in serum creatinine and neurohormonal activation. Additionally, loop diuretic use vs. UF was associated with an increase in serum bicarbonate despite less decongestion, data which question the commonly held conception of a ‘contraction alkalosis’.

     

A Meta‐Analysis of Sex‐Related Differences in Outcomes After Primary Percutaneous Intervention for ST‐Segment Elevation Myocardial Infarction

Introduction

The increasing use of primary percutaneous coronary intervention (pPCI) has improved clinical outcome in ST‐segment elevation myocardial infarction (STEMI) patients, but the impact of sex on early and mid‐term outcomes remains to be defined.

Methods

Medline, Cochrane Library, Biomed Central, and Google Scholar were searched for articles describing differences in baseline, periprocedural, and midterm outcomes after pPCI, by sex. The primary end point was all‐cause mortality at early and mid‐term follow‐up. Secondary endpoints included in‐hospital bleeding and stroke.

Results

Sixteen studies were included. Women were older, had more frequent hypertension, diabetes mellitus, and hypercholesterolemia, as well as longer ischemia time and more shock at presentation. Men were more likely to have had a previous myocardial infarction. Female sex emerged as independently associated to early mortality (OR 1.1; 95%CI, 1.02–1.18) but not to mid‐term mortality (OR, 1.01; 95%CI, 0.99–1.03). The pooled analysis showed a significantly higher risk of in hospital stroke (OR, 1.69; 95%CI, 1.11–2.56) and major bleeding (OR, 2.04; 95%CI, 1.51–2.77) in women.

Conclusions

As compared to men, women undergoing pPCI have more bleedings and strokes, and a worse early, but not mid‐term mortality. These findings may allow a better risk stratification of pPCI patients.

     

Factors associated with underuse of mineralocorticoid receptor antagonists in heart failure with reduced ejection fraction: an analysis of 11 215 patients from the Swedish Heart Failure Registry

Aim

Mineralocorticoid receptor antagonists (MRAs) improve outcomes in heart failure with reduced ejection fraction (HFrEF), but are underutilized. Hyperkalaemia may be one reason, but the underlying reasons for underuse are unknown. The aim of this study was to investigate the independent predictors of MRA underuse in a large and unselected HFrEF cohort.

Methods and results

We included patients with HFrEF (ejection fraction <40%), New York Heart Association (NYHA) class II–IV and heart failure (HF) duration ≥6 months from the Swedish HF Registry. Logistic regression analysis identified independent associations between 39 demographic, clinical, co‐treatment, and socioeconomic predictors and MRA non‐use. Of 11 215 patients, 27% were women; mean age was 75 ± 11 years; only 4443 (40%) patients received MRA. Selected characteristics independently associated with MRA non‐use were in descending order of magnitude: lower creatinine clearance (<60 mL/min), no need for diuretics, no cardiac resynchronization therapy/implantable cardioverter‐defibrillator, higher blood pressure, no digoxin use, higher ejection fraction, outpatient setting, older age, lower income, ischaemic heart disease, male sex, follow‐up in primary vs. specialty care, lower NYHA class, and absence of hypertension diagnosis. Plasma potassium and N‐terminal pro B‐type natriuretic peptide levels were not associated with MRA non‐use.

Conclusion

Mineralocorticoid receptor antagonists remain underused in HFrEF. Their use does not decrease with elevated potassium but does with impaired renal function, even in the creatinine clearance 30–59.9 mL/min range where MRAs are not contraindicated. MRA underuse may be further related to non‐specialist care, milder HF and no use of other HF therapy.

     

Rationale and Design of the On‐Treatment PLAtelet Reactivity‐Guided Therapy Modification FOR ST‐Segment Elevation Myocardial Infarction (PLATFORM) Randomized Trial

Objectives

The present trial aims at examining whether antiplatelet regimen modification, guided by assessment of the on‐treatment platelet reactivity, might result with clinical benefit in moderate to high‐risk patients with ST‐elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

Background

High platelet reactivity has been associated with an increased rate of ischemic events after PCI. Recent large trials did not show a clinical benefit of platelet reactivity‐guided therapy modification in acute coronary syndrome patients treated by PCI.

Methods

PLATFORM is an investigator‐initiated, prospective, randomized, parallel‐group, controlled clinical trial. Approximately 632 STEMI patients with intermediate to high‐risk (RISK‐PCI score >3) clinical features undergoing PPCI will be randomly allocated to treatment modification or standard therapy. Low responders to aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor for 1 year. The primary end‐point is the time to the first composite major adverse cardiovascular events (MACE) including death, nonfatal infarction, stroke, or immediate target vessel revascularization. Key safety end‐point is the rate of TIMI major bleeding unrelated to coronary artery bypass graft surgery. Our secondary end‐points are individual components of MACE, definite stent thrombosis, total bleeding, and the need for blood transfusions. Patients will be followed‐up at 30 days and at 1 year after PPCI.

Conclusion

PLATFORM will determine whether the platelet reactivity‐guided use of ticagrelor in combination with 200 mg aspirin, compared with standard antiplatelet regimen, improves clinical outcome in moderate to high‐risk STEMI patients undergoing PPCI.

Clinical Trial Registration

U.S. National Institutes of Health (NIH) at www.clinicaltrials.gov . ClinicalTrials.gov Identifier: NCT01739556, and Current Controlled Trials at www.controlledtrials.com . International Standard Randomized Controlled Trial Number ISRCTN83081599. (J Interven Cardiol 2013;26:221–227)

     

Comparison of long‐term outcome in anthracycline‐related versus idiopathic dilated cardiomyopathy: a single centre experience

Aims

Cardiac dysfunction is a severe complication of anthracycline‐containing anticancer therapy. The outcome of anthracycline‐induced cardiomyopathy (AICM) compared with other non‐ischaemic causes of heart failure (HF), such as idiopathic dilated cardiomyopathy (IDCM), is unresolved. The aim of this study was to compare the survival of AICM patients with an IDCM cohort followed at our centre from 1990 to 2016.

Methods and results

We included 67 patients (67% female, 50 ± 15 years) with AICM, defined as onset of otherwise unexplained left ventricular ejection fraction (LVEF) ≤50% following anthracycline therapy, and 488 IDCM patients (28% female, 55 ± 12 years). Patients were followed with constantly optimized HF therapy, for 7.6 ± 5.5 and 8.1 ± 5.5 years, respectively. In both cohorts, 25% of patients reached the combined endpoint of death/heart transplantation. Overall survival rates at 5 and 10 years were similar (AICM: 86% and 61%, IDCM: 88% and 75%; P = 0.61), and so was cardiovascular survival (AICM: 91% and 76%, IDCM: 91% and 80%; P = 0.373), also after 1:1 propensity matching (P = 0.27) and adjusting for age, LVEF and left ventricular size. A trend toward higher all‐cause mortality was present in AICM patients [hazard ratio (HR) 1.67, 95% confidence interval (CI) 0.95–2.92, P = 0.076]. No differences were observed between AICM and IDCM with regard to pharmacological HF therapy, but AICM patients were less likely to receive devices (13% vs. 41.8% in IDCM, P < 0.001).

Conclusion

Cardiovascular mortality in patients with AICM did not differ from that of a matched IDCM cohort, despite cancer‐related morbidity and less prevalent use of devices. These data suggest that patients with AICM should be treated with appropriate guideline‐directed medical therapies similar to other non‐ischaemic dilated cardiomyopathies.

     

Prognostic value of psychosocial factors for first and recurrent hospitalizations and mortality in heart failure patients: insights from the OPERA‐HF study

Aims

Psychosocial factors are rarely collected in studies investigating the prognosis of patients with heart failure (HF), and only time to first event is commonly reported. We investigated the prognostic value of psychosocial factors for predicting first or recurrent events after discharge following hospitalization for HF.

Methods and results

OPERA‐HF is an observational study enrolling patients hospitalized for HF. In addition to clinical variables, psychosocial variables are recorded. Patients provide the information through questionnaires that include social information, depression and anxiety scores, and cognitive function. Kaplan–Meier, Cox regression and the Andersen–Gill model were used to identify predictors of first and recurrent events (readmissions or death). Of 671 patients (age 76 ± 15 years, 66% men) with 1‐year follow‐up, 291 had no subsequent event, 34 died without being readmitted, 346 had one or more unplanned readmissions, and 71 patients died after a first readmission. Increasing age, higher urea and creatinine, and the presence of co‐morbidities (diabetes, history of myocardial infarction, chronic obstructive pulmonary disease) were all associated with increasing risk of first or recurrent events. Psychosocial variables independently associated with both the first and recurrent events were: presence of frailty, moderate‐to‐severe depression, and moderate‐to‐severe anxiety. Living alone and the presence of cognitive impairment were independently associated only with an increasing risk of recurrent events.

Conclusion

Psychosocial factors are strongly associated with unplanned recurrent readmissions or mortality following an admission to hospital for HF. Further research is needed to show whether recognition of these factors and support tailored to individual patients' needs will improve outcomes.

     

Drug‐Coated Balloons: A Safe and Effective Alternative to Drug‐Eluting Stents in Small Vessel Coronary Artery Disease

Background

Drug‐coated balloons (DCB) have been used to treat de novo small vessel coronary disease (SVD), with promising results and shorter dual antiplatelet therapy (DAPT) duration compared to drug‐eluting stents (DES). We compared safety and effectiveness of the two treatments at 1 year.

Methods

We reviewed 3,613 angioplasty cases retrospectively from 2011 to 2013 and identified 335 patients with SVD treated with device diameter of ≤2.5 mm. DCB‐only angioplasty was performed in 172 patients, whereas 163 patients were treated with second‐generation DES.

Results

DCB patients had smaller reference vessel diameter (2.22 ± 0.30 vs. 2.44 ± 0.19 mm, P < 0.001) and received smaller devices (median diameter 2.25 vs. 2.50 mm, P < 0.001) compared to the DES group. DES‐treated vessels had larger acute lumen gain (1.71 ± 0.48 mm) than DCB (1.00 ± 0.53 mm, P < 0.001). Half the patients had diabetes mellitus. While there were more patients presenting with acute coronary syndrome (ACS) in the DCB group (77.9% vs. 62.2%, P = 0.013), they received shorter DAPT (7.4 ± 4.7 vs. 11.8 ± 1.4 months, P < 0.001) than the DES group. The 1‐year composite major adverse cardiac event rate was 11.6% in the DCB arm and 11.7% in the DES arm (P = 1.000), with target lesion revascularization rate of 5.2% and 3.7%, respectively, (P = 0.601).

Conclusions

In this high‐risk cohort of patients, DCB‐only angioplasty delivered good clinical outcome at 1 year. The results were comparable with DES‐treated patients, but had the added benefit of a shorter DAPT regime.

     

Implantable cardioverter‐defibrillators in heart failure patients with reduced ejection fraction and diabetes

Aim

There is limited information on the outcomes after primary prevention implantable cardioverter‐defibrillator (ICD) implantation in patients with heart failure (HF) and diabetes. This analysis evaluates the effectiveness of a strategy of ICD plus medical therapy vs. medical therapy alone among patients with HF and diabetes.

Methods and results

A patient‐level combined‐analysis was conducted from a combined dataset that included four primary prevention ICD trials of patients with HF or severely reduced ejection fractions: Multicenter Automatic Defibrillator Implantation Trial I (MADIT I), MADIT II, Defibrillators in Non‐Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE), and Sudden Cardiac Death in Heart Failure Trial (SCD‐HeFT). In total, 3359 patients were included in the analysis. The primary outcome of interest was all‐cause death. Compared with patients without diabetes (n = 2363), patients with diabetes (n = 996) were older and had a higher burden of cardiovascular risk factors. During a median follow‐up of 2.6 years, 437 patients without diabetes died (178 with ICD vs. 259 without) and 280 patients with diabetes died (128 with ICD vs. 152 without). ICDs were associated with a reduced risk of all‐cause mortality among patients without diabetes [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.46–0.67] but not among patients with diabetes (HR 0.88, 95% CI 0.7–1.12; interaction P = 0.015).

Conclusion

Among patients with HF and diabetes, primary prevention ICD in combination with medical therapy vs. medical therapy alone was not significantly associated with a reduced risk of all‐cause death. Further studies are needed to evaluate the effectiveness of ICDs among patients with diabetes.

     

Genotype–phenotype relationship and risk stratification in loss‐of‐function SCN5A mutation carriers

Introduction

Loss‐of‐function (LoF) mutations in the SCN5A gene cause multiple phenotypes including Brugada Syndrome (BrS) and a diffuse cardiac conduction defect. Markers of increased risk for sudden cardiac death (SCD) in LoF SCN5A mutation carriers are ill defined. We hypothesized that late potentials and fragmented QRS would be more prevalent in SCN5A mutation carriers compared to SCN5A‐negative BrS patients and evaluated risk markers for SCD in SCN5A mutation carriers.

Methods

We included all SCN5A loss‐of‐function mutation carriers and SCN5A‐negative BrS patients from our center. A combined arrhythmic endpoint was defined as appropriate ICD shock or SCD.

Results

Late potentials were more prevalent in 79 SCN5A mutation carriers compared to 39 SCN5A‐negative BrS patients (66% versus 44%, p = .021), while there was no difference in the prevalence of fragmented QRS. PR interval prolongation was the only parameter that predicted the presence of a SCN5A mutation in BrS (OR 1.08; p < .001). Four SCN5A mutation carriers, of whom three did not have a diagnostic type 1 ECG either spontaneously or after provocation with a sodium channel blocker, reached the combined arrhythmic endpoint during a follow‐up of 44 ± 52 months resulting in an annual incidence rate of 1.37%.

Conclusion

LP were more frequently observed in SCN5A mutation carriers, while fQRS was not. In SCN5A mutation carriers, the annual incidence rate of SCD was non‐negligible, even in the absence of a spontaneous or induced type 1 ECG. Therefore, proper follow‐up of SCN5A mutation carriers without Brugada syndrome phenotype is warranted.

     

Complete versus incomplete revascularization with drug‐eluting stents for multi‐vessel disease in stable,unstable angina or non‐ST‐segment elevation myocardial infarction: A meta‐analysis

Objectives

To determine whether drug‐eluting stent (DES) coronary complete revascularization (CR) confers clinical benefit over incomplete revascularization (IR) in patients with multivessel coronary artery disease (MVD).

Background

Clinical benefit of CR over IR in patients with MVD with angina (both stable and unstable) and non‐ST‐segment elevation myocardial infarction (NSTEMI) in DES has not been well studied.

Methods

We conducted a systematic online literature search of PUBMED and EMBASE. Literatures that compared the clinical outcomes between CR and IR with exclusively or majority (>80%) using DES in patients without or included only small portion (<20%) of ST‐segment elevation myocardial infarction or single‐vessel coronary artery disease were included. Hazards ratio (HR) with 95% confidence interval (CI) was calculated with random‐effects model.

Results

No randomized clinical trials were identified. A total of 14 observational studies with total of 41 687 patients (CR 39.6% and IR 60.4%) were included in this meta‐analysis. CR was associated with lower incident of all‐cause mortality (HR 0.71, P = 0.001), major adverse events (HR 0.75, P < 0.001), cardiovascular mortality (HR 0.39, P < 0.001). Meta‐regression analysis showed that CR significantly reduced the risk of all‐cause mortality in advanced age, triple vessel disease and male sub‐groups.

Conclusions

CR with DES conferred favorable outcomes compared to IR in MVD patients with stable, unstable angina or NTEMI. Further research to achieve higher CR in MVD patients may lead to improvement in prognosis in these cohorts.