The benefit of an implantable cardioverter-defibrillator (ICD) in patients with symptomatic systolic heart failure caused by coronary artery disease has been well documented. However, the evidence ...for a benefit of prophylactic ICDs in patients with systolic heart failure that is not due to coronary artery disease has been based primarily on subgroup analyses. The management of heart failure has improved since the landmark ICD trials, and many patients now receive cardiac resynchronization therapy (CRT).
In a randomized, controlled trial, 556 patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD, and 560 patients were assigned to receive usual clinical care (control group). In both groups, 58% of the patients received CRT. The primary outcome of the trial was death from any cause. The secondary outcomes were sudden cardiac death and cardiovascular death.
After a median follow-up period of 67.6 months, the primary outcome had occurred in 120 patients (21.6%) in the ICD group and in 131 patients (23.4%) in the control group (hazard ratio, 0.87; 95% confidence interval CI, 0.68 to 1.12; P=0.28). Sudden cardiac death occurred in 24 patients (4.3%) in the ICD group and in 46 patients (8.2%) in the control group (hazard ratio, 0.50; 95% CI, 0.31 to 0.82; P=0.005). Device infection occurred in 27 patients (4.9%) in the ICD group and in 20 patients (3.6%) in the control group (P=0.29).
In this trial, prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease was not associated with a significantly lower long-term rate of death from any cause than was usual clinical care. (Funded by Medtronic and others; DANISH ClinicalTrials.gov number, NCT00542945 .).
Values of effective pulmonary blood flow (Q(EP)) and cardiac output, determined by a non-invasive foreign gas rebreathing method (CO(RB)) using a new infrared photoacoustic gas analysing system, were ...compared with measurements of cardiac output obtained by the direct Fick (CO(FICK)) and thermodilution (CO(TD)) methods in patients with heart failure or pulmonary hypertension. In 11 patients, of which three had shunt flow through areas without significant gas exchange, the mean difference (bias) and limits of agreement (+/- 2 S.D.) were 0.6 +/- 1.2 litre x min(-1) when comparing CO(FICK) and Q(EP), and -0.8 +/- 1.3 litre x min(-1) when comparing CO(FICK) and CO(TD). When correction for intrapulmonary shunt flow was applied (i.e. calculation of CO(RB)) in all 11 patients, the bias between CO(FICK) and CO(RB) was 0.1 +/- 0.9 litre x min(-1), primarily because agreement improved in the three patients with significant shunt flow. In the eight patients without significant shunt flow, the agreement between Q(EP) and CO(FICK) was 0.3 +/- 0.9 litre x min(-1). In conclusion, a foreign gas rebreathing method with a new infrared photoacoustic gas analyser provided at least as reliable a measure of cardiac output as did thermodilution. In the absence of significant shunt flow, measurement of Q(EP) itself provides a reliable estimate of cardiac output in heart failure patients. The infrared photoacoustic gas analyser markedly facilitates clinical use of the rebreathing method in general, which makes the method available to a larger group of clinicians working with patients with cardiovascular diseases.
The DANISH study (Danish Study to Assess the Efficacy of ICDs Implantable Cardioverter Defibrillators in Patients With Non-Ischemic Systolic Heart Failure on Mortality) did not demonstrate an overall ...effect on all-cause mortality with ICD implantation. However, the prespecified subgroup analysis suggested a possible age-dependent association between ICD implantation and mortality with survival benefit seen only in the youngest patients. The nature of this relationship between age and outcome of a primary prevention ICD in patients with nonischemic systolic heart failure warrants further investigation.
All 1116 patients from the DANISH study were included in this prespecified subgroup analysis. We assessed the relationship between ICD implantation and mortality by age, and an optimal age cutoff was estimated nonparametrically with selection impact curves. Modes of death were divided into sudden cardiac death and nonsudden death and compared between patients younger and older than this age cutoff with the use of χ
analysis.
Median age of the study population was 63 years (range, 21-84 years). There was a linearly decreasing relationship between ICD and mortality with age (hazard ratio HR, 1.03; 95% confidence interval CI, 1.003-1.06;
=0.03). An optimal age cutoff for ICD implantation was present at ≤70 years. There was an association between reduced all-cause mortality and ICD in patients ≤70 years of age (HR, 0.70; 95% CI, 0.51-0.96;
=0.03) but not in patients >70 years of age (HR, 1.05; 95% CI, 0.68-1.62;
=0.84). For patients ≤70 years old, the sudden cardiac death rate was 1.8 (95% CI, 1.3-2.5) and nonsudden death rate was 2.7 (95% CI, 2.1-3.5) events per 100 patient-years, whereas for patients >70 years old, the sudden cardiac death rate was 1.6 (95% CI, 0.8-3.2) and nonsudden death rate was 5.4 (95% CI, 3.7-7.8) events per 100 patient-years. This difference in modes of death between the 2 age groups was statistically significant (
=0.01).
In patients with systolic heart failure not caused by ischemic heart disease, the association between the ICD and survival decreased linearly with increasing age. In this study population, an age cutoff for ICD implantation at ≤70 years yielded the highest survival for the population as a whole.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT00542945.
The prevalence, prognostic importance, and factors that predict the presence and degree of pulmonary hypertension (PH) diagnosed with right heart catheterization (RHC) in patients with end-stage ...chronic obstructive pulmonary disease (COPD) remain unclear.
This retrospective study included 409 patients (61% women) with COPD/emphysema or α-1-antitrypsin deficiency who underwent lung transplant evaluation during 1991 to 2010. We analyzed the occurrence and degree of PH and compared demographics, oxygenation, lung function, hemodynamics, functional capacity, and survival in patients with and without PH. Prediction of PH was assessed using univariate and multivariate regression analysis.
The mean age at evaluation was 54 ± 7 years. All patients were in New York Heart Association functional class III-IV, with forced expiratory volume in 1 second of 23% ± 7% and total lung capacity of 126% ± 21% of predicted. PH was present in 146 (36%). The analysis excluded 53 (13%) with pulmonary venous hypertension (PVH). The distribution of the mean pulmonary artery pressure (mPAP) in patients with or without PH showed a unimodal normally distributed population, with a mean of 23.8 ± 6.0 mm Hg. Predictors of PH were partial pressures of oxygen and carbon dioxide. The 5-year survival rate was 37% in COPD patients with PH vs 63% in patients without PH (p = 0.016). Survival after lung transplantation did not differ (p = 0.37).
RHC verified PH in 36% of COPD patients. Hypoxemia and hypercapnia were associated with mPAP. PH is associated with worse survival in COPD, but PH does not influence the prognosis after lung transplantation.
The incidence of ventricular tachycardia (VT) or ventricular fibrillation (VF) in patients supported with a continuous-flow left ventricular assist device (LVAD) has not been investigated in detail. ...In 23 consecutive recipients of a HeartMate II, we analyzed the incidence of VT/VF during a total of 266 months of follow-up. Sustained VT or VF occurred in 52% of the patients, with the majority of arrhythmias occurring in the first 4 weeks after LVAD implantation. VT/VF requiring implantable cardioverter-defibrillator (ICD) shock or external defibrillation occurred in 8 patients and significant hemodynamic instability ensued in 3 patients. There were no clear predictors of VT/VF, and it is argued that prophylactic ICD implantation should be considered in patients supported with a continuous-flow LVAD.
The objectives of this study were to assess the frequency and severity of pulmonary hypertension (PH) and the effect of sildenafil treatment in patients with recalcitrant pulmonary sarcoidosis.
This ...investigation was a single-center, retrospective study of all patients (n = 25) with end-stage pulmonary sarcoidosis referred for lung transplantation. Hemodynamic measurements were evaluated by right-side cardiac catheterization in 24 of 25 patients. Sildenafil treatment for patients with sarcoidosis-associated PH was introduced in April 2004.
The study group of 24 patients (16 men, 8 women) had a median age of 45 (range 35 to 58) years, and duration of sarcoidosis of 11 (range 2 to 38) years. Mean pulmonary arterial pressure (MPAP) was median 36 (range 18 to 73) mm Hg. PH (MPAP >25 mm Hg) was present in 19 of 24 patients (79%). Sildenafil was administered to 12 of 13 patients at a dose of 150 (range 75 to 225) mg/day for 4 (range 1 to 12) months. Sildenafil treatment was associated with reductions in MPAP of -8 mm Hg (CI -1 to -15 mm Hg), and PVR -4.9 Wood units (CI -7.2 to -2.6 Wood units). Cardiac output and cardiac index also increased during treatment (p = 0.01, respectively). There were no consistent changes in 6-minute walk distance.
Patients with severe pulmonary sarcoidosis have a high prevalence of PH. Sildenafil treatment was associated with significant improvements in hemodynamic parameters.
Background
Little systematic evidence is available on potential gender differences in patients with an implantable cardioverter defibrillator (ICD) from a real‐world cohort. We designed the ...DEFIB‐WOMEN (The Utilization of Implantable Cardioverter DEFIBrillator Therapy in the Treatment of Heart Disease: Clinical and Psychological outcomes in WOMEN) study to examine gender differences on (1) patient‐reported outcomes (PROs), (2) procedure‐ and device‐related complications, and (3) ventricular tachyarrhythmia and mortality. This presents the study design and baseline characteristics of the cohort.
Methods
DEFIB‐WOMEN is a national, multicenter, prospective, observational study. First‐time implanted patients are asked to complete PROs at several time points. Information on baseline and follow‐up characteristics are captured from patients’ medical records, purpose‐designed questions, and the Danish national registers. The DEFIB‐WOMEN cohort is composed of 1,790 (19% women; 343/1,790) patients implanted between June 2010 and April 2013.
Results
Women and men differed on several demographic and clinical baseline characteristics, including on the prescription of β‐blockers, statins, angiotensin‐converting enzyme inhibitors, and psychotropic agents. Although women generally had a healthier clinical profile, they reported significantly more symptoms of anxiety and depression and ICD concerns (fear of shock) as compared to men. These differences were not only statistically significant but also clinically relevant, with the magnitude of the differences in anxiety and ICD concerns being 0.44 and 0.42, respectively, as indicated by Cohen's effect size index.
Conclusions
These preliminary results indicate that women with an ICD experience particularly more anxiety and ICD concerns as compared to men at the time of implant. Future results of DEFIB‐WOMEN will show whether these gender differences persist and whether there are also gender differences in complications and survival.
Abstract
Aim
The Danish Study to Assess the Efficacy of Implantable Cardioverter-Defibrillators (ICD) in Patients with Non-ischaemic Systolic Heart Failure (HF) on Mortality (DANISH) found no overall ...effect on all-cause mortality. The effect of ICD implantation on health-related quality of life (HRQoL) remains to be established as previous trials have demonstrated conflicting results. We investigated the impact of ICD implantation on HRQoL in patients with non-ischaemic systolic HF, a prespecified secondary endpoint in DANISH.
Methods and results
In DANISH, a total of 1116 patients with non-ischaemic systolic HF were randomly assigned (1:1) to ICD implantation or usual clinical care (control). Patients completed disease-specific HRQoL as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ; 0–105, high indicating worse). Changes in HRQoL 8 months after randomization were assessed with a mixed-effects model. At randomization, MLHFQ was completed by 935 (84%) patients (n = 472 in the ICD group and n = 463 in the control group) and was reassessed in 274 (58%) and 292 (63%) patients, respectively after 8 months for the primary analysis. Patients in the ICD group vs. the control group had similar improvements in MLHFQ after 8 months least square mean −7.0 vs. −4.2 (P = 0.13). A clinically relevant improvement (decrease ≥5) in the MLHFQ overall score at 8 months was observed in 151 patients in the ICD group and 148 patients in the control group 55% vs. 51%, respectively (P = 0.25).
Conclusion
Implantable cardioverter-defibrillator implantation in patients with non-ischaemic systolic HF did not significantly alter HRQoL compared with patients randomized to usual clinical care.
To evaluate the incidences of and risk factors predisposing to appropriate and inappropriate shocks and mortality in a 'real-world' population of patients with ischaemic heart disease (IHD) and ...implantable cardioverter defibrillators (ICD) for primary prevention of sudden cardiac death (SCD).
In this nationwide cohort, we prospectively followed 1609 patients with IHD and left ventricular dysfunction from the Danish ICD Register who received an ICD for primary prevention of SCD (1 January 2007 to 30 November 2011). Primary study outcomes were appropriate shocks, inappropriate shocks, and all-cause mortality. Secondary study outcomes included the composite endpoints: appropriate therapy and inappropriate therapy (defined as shock or anti-tachycardia pacing). All-cause mortality was 12.1% during a mean follow-up time of 1.9 ± 1.3 years. Inappropriate shocks and therapy occurred in 2.6% and 3.7% during follow-up, respectively. Appropriate shocks and therapy was identified in 7.8% and 13.4%, respectively. Time-dependent multivariable Cox regression analyses were used to identify risk factors of inappropriate/appropriate shock, therapy and mortality. Implantation of a dual-chamber ICD was associated with increased risk of both inappropriate shocks and any inappropriate therapy compared to single-chamber ICD hazard ratios (HR) = 2.45; confidence intervals (CI):1.16-5.14 and HR = 2.38; CI:1.28-4.42, respectively. No excess risk of mortality was associated with any device type.
In this nationwide study of IHD patients with an ICD for primary prevention of SCD, the incidence of appropriate shocks as well as inappropriate shocks were significantly lower than reported in randomized trials. Implantation of a dual-chamber ICD was associated with more inappropriate shocks compared with single chamber devices.
Objective: Cardiovascular implantable electronic device (CIED) infections are increasing in numbers. The objective was to review the clinical presentation and outcome in patients affected with CIED ...infections with either local pocket or systemic presentation. Design: All device removals due to CIED infection during the period from 2005 to 2012 were retrospectively reviewed. CIED infections were categorized as systemic or pocket infections. Treatment included complete removal of the device, followed by antibiotic treatment of six weeks. Results: Seventy-one device removals due to infection (32 systemic and 39 pocket infections) were recorded during the study period. Median follow-up time was 26 (IQR 9-41) months, 30 day and 12 month mortality were 4% and 14%, respectively. There was no long-term difference in mortality between patients with pocket vs. systemic infection (p = 0.48). During follow-up no relapses and two cases of new infections were noted (2.8%). Conclusions: CIED infection with systemic or pocket infection was difficult to distinguish in clinical presentation and outcome. Complete device removal and antibiotic treatment of long duration was safe and without relapses.
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