The choice of resynchronization therapy between with (CRT-D) and without (CRT-P) a defibrillator remains a contentious issue. Cause-of-death analysis among CRT-P, compared with CRT-D, patients could ...help evaluate the extent to which CRT-P patients would have additionally benefited from a defibrillator in a daily clinical practice.
A total of 1705 consecutive patients implanted with a CRT (CRT-P: 535 and CRT-D: 1170) between 2008 and 2010 were enrolled in CeRtiTuDe, a multicentric prospective follow-up cohort study, with specific adjudication for causes of death at 2 years. Patients with CRT-P compared with CRT-D were older (P < 0.0001), less often male (P < 0.0001), more symptomatic (P = 0.0005), with less coronary artery disease (P = 0.003), wider QRS (P = 0.002), more atrial fibrillation (P < 0.0001), and more co-morbidities (P = 0.04). At 2-year follow-up, the annual overall mortality rate was 83.80 95% confidence interval (CI) 73.41-94.19 per 1000 person-years. The crude mortality rate among CRT-P patients was double compared with CRT-D (relative risk 2.01, 95% CI 1.56-2.58). In a Cox proportional hazards regression analysis, CRT-P remained associated with increased mortality (hazard ratio 1.54, 95% CI 1.07-2.21, P = 0.0209), although other potential confounders may persist. By cause-of-death analysis, 95% of the excess mortality among CRT-P subjects was related to an increase in non-sudden death.
When compared with CRT-D patients, excess mortality in CRT-P recipients was mainly due to non-sudden death. Our findings suggest that CRT-P patients, as currently selected in routine clinical practice, would not potentially benefit with the addition of a defibrillator.
Professional practice guidelines recommend that pacemaker recipients be followed regularly. However, the majority of scheduled ambulatory visits is unproductive and imposes a heavy burden on the ...health-care system.
The COMPAS randomized, multicentre, non-inferiority trial examined the safety of long-term remote monitoring of pacemakers. Between December 2005 and January 2008, 538 patients were randomly assigned to remote monitoring follow-up (active group) vs. standard care (control group). The primary objective was to confirm that the proportion of patients who experienced at least one major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events, was not >7% higher in the active than in the control group. MAE-free survivals and quality of life were compared in both groups. The characteristics of the study groups were similar. Over a follow-up of 18.3 months, 17.3% of patients in the active and 19.1% in the control group experienced at least one MAE (P < 0.01 for non-inferiority). Hospitalizations for atrial arrhythmias (6 vs. 18) and strokes (2 vs. 8) were fewer (P < 0.05), and the number of interim ambulatory visits was 56% lower (P < 0.001) in the active than the control group. Changes in pacemaker programming or drug regimens were made in 62% of visits in the active vs. 29% in the control group (P < 0.001). Quality of life remained unchanged in both groups.
Remote monitoring was a safe alternative to conventional care and significantly lowered the number of ambulatory visits during long-term follow-up of permanently paced patients. ClinicalTrials.gov identifier: NCT00989326.
Limited data are available on long-term prognosis or causes-of-death analysis among survivors of acute myocardial infarction (MI) according to whether or not they developed ventricular fibrillation ...(VF) during the acute stage of MI.
Among 3670 MI patients hospitalized in France in 2005 and enrolled in this prospective follow-up cohort study, we assessed in-hospital mortality and 5-year cause of death among those who survived to hospital discharge, according to whether they developed VF (116 cases) or not, during the acute stage. 94.5% of patients had complete follow-up at 5 years. In-hospital mortality was significantly higher among VF patients (adjusted OR 7.38, 95% CI 4.27-12.75, P < 0.001). Among 3463 survivors at hospital discharge, 1024 died during a mean follow-up of 52 ± 2 months. The overall survival rate at 5 years was 74.4% (95% CI 72.8-76.0). In Cox multivariate analysis, occurrence of VF during the acute phase of MI was not associated with an increased mortality at 5 years (HR 0.78, 95% CI 0.38-1.58, P = 0.21). The distribution of causes of death at 5 years did not statistically differ according to the presence or absence of VF, especially for sudden cardiac death (13.1% in VF group vs.12.9% in non-VF group), despite a very low rate of implantation of cardioverter defibrillator in both groups (Overall rate 1.2%).
Patients developing VF in the setting of acute MI are at higher risk of in-hospital mortality. However, VF is not associated with a higher long-term all-cause or sudden cardiac death mortality.
Compared with the first-generation Arctic Front cryoballoon (ARC-CB), the new Arctic Front Advance cryoballoon (ARC-Adv-CB) increases the efficient CB-tissue contact surface during freezing, which ...may increase the incidence of phrenic nerve (PN) palsy (PNP).
To evaluate the safety and efficacy of paroxysmal atrial fibrillation (AF) ablation with the ARC-Adv-CB as well as the merits of a predictor of PNP.
AF ablation was performed by using a "single 28-mm big CB" approach. The rate of pulmonary vein (PV) isolation with a first cryoapplication was measured. The distance between the CB and a PN pacing catheter in the superior vena cava was measured to predict PNP during freezing.
In 147 patients, PV were isolated with a single cryoapplication in 205 (81.3%) of 252 PV treated with the ARC-CB and in 280 (90.3%) of 310 PV treated with the ARC-Adv-CB (P = .003). The mean time to PV isolation was 52 ± 34 seconds and 40 ± 25 seconds (P < .001) and the temperature at the time of isolation was -36.1 ± 10.3°C and -32.3 ± 10.2°C (P = .001) in the ARC-CB and ARC-Adv-CB groups, respectively. Mean procedure and fluoroscopy durations were significantly shorter in the ARC-Adv-CB group. Transient PNP was observed in 7(10.6%) and 20(24.4%) of the patients treated with the ARC-CB and ARC-Adv-CB, respectively (P = .048). The distance between the lateral edge of the CB and a vertical line through the tip of the pacing catheter accurately predicted PNP (P < .001).
The 28-mm ARC-Adv-CB enabled more efficient ablation of paroxysmal AF and shorter procedures than did the ARC-CB. This higher performance was associated with a higher incidence of PNP, which was predicted by the distance between the CB and the PN.
The main objective of this study was to assess if the benefits of biventricular (BiV) pacing observed during the crossover phase were sustained over 12 months.
MUltisite STimulation In ...Cardiomyopathies (MUSTIC) is a randomized controlled study intended to evaluate the effects of BiV pacing in patients with New York Heart Association (NYHA) class III heart failure and intraventricular conduction delay.
Of 131 patients included, 42/67 in sinus rhythm (SR) and 33/64 in atrial fibrillation (AF) were followed up longitudinally at 9 and 12 months by 6-min walked distance, peak oxygen uptake (peak VO2), quality of life by the Minnesota score, NYHA class, echocardiography, and left ventricular ejection fraction by radionuclide technique.
At 12 months, all SR and 88% of AF patients were programmed to BiV pacing. Compared with baseline, the 6-min walked distance increased by 20% (SR) (p = 0.0001) and 17% (AF) (p = 0.004); the peak VO2by 11% (SR) and 9% (AF); quality of life improved by 36% (SR) (p = 0.0001) and 32% (AF) (p = 0.002); NYHA class improved by 25% (SR) (p = 0.0001) and 27% (AF) (p = 0.0001). The ejection fraction improved by 5% (SR) and 4% (AF). Mitral regurgitation decreased by 45% (SR) and 50% (AF).
The clinical benefits of BiV pacing appeared to be significantly maintained over a 12-month follow-up period.
Objectives The study sought to describe a specific syndrome characterized by isolated left bundle branch block (LBBB) and a history of progressive left ventricular (LV) dysfunction, successfully ...treated by cardiac resynchronization therapy (CRT). Background Isolated LBBB in animals causes cardiac remodeling due to mechanical dyssynchrony, reversible by biventricular stimulation. However, the existence of LBBB-induced cardiomyopathy in humans remains uncertain. Methods Between 2007 and 2010, 375 candidates for CRT were screened and retrospectively included in this study if they met all criteria of a pre-defined syndrome, including: 1) history of typical LBBB for >5 years; 2) LV ejection fraction (EF) >50%; 3) decrease in LVEF to <40% and development of heart failure (HF) to NYHA functional class II to IV over several years; 4) major mechanical dyssynchrony; 5) no known etiology of cardiomyopathy; and 6) super-response to CRT with LVEF >45% and decrease in NYHA functional class at 1 year. Results The syndrome was identified in 6 patients (1.6%), 50.5 years of age on average at the time of LBBB diagnosis. HF developed over a mean of 11.6 years. At the time of referral, Doppler echocardiograms showed major mechanical dyssynchrony at left atrioventricular, interventricular, and left intraventricular levels. During CRT, NYHA functional class decreased, LV dimensions normalized and mechanical dyssynchrony was nearly resolved in all patients, and mean LVEF increased from 31 ± 12% to 56 ± 8% (p = 0.027). Conclusions These observations support the existence of a specific LBBB-induced cardiomyopathy resolved by CRT. Its prevalence, time course, and risk factors need to be prospectively studied.
Aims
The prevalence of cardiovascular and non‐cardiovascular co‐morbidities and their relative importance for outcomes in heart failure with preserved ejection fraction (HFPEF) remain poorly ...characterized. This study aimed to investigate this.
Methods and results
The Karolinska–Rennes (KaRen) Study was a multinational prospective observational study designed to characterize HFPEF. Inclusion required acute HF, defined by the Framingham criteria, LVEF ≥45%, and NT‐pro‐BNP ≥300 ng/L or BNP ≥100 ng/L. Detailed clinical data were collected at baseline and patients were followed prospectively for 18 months. Predictors of the primary (HF hospitalization or all‐cause mortality) and secondary (all‐cause mortality) outcomes were assessed with multivariable Cox regression. A total of 539 patients 56% women; median (interquartile range) age 79 (72–84) years; NT‐pro‐BNP/BNP 2448 (1290–4790)/429 (229–805) ng/L were included. Known history of HF was present in 40%. Co‐morbidities included hypertension (78%), atrial fibrillation/flutter (65%), anaemia (51%), renal dysfunction (46%), CAD (33%), diabetes (30%), lung disease (25%), and cancer (16%). The primary outcome occurred in 268 patients 50%; 106 deaths (20%) and 162 HF hospitalizations (30%). Important independent predictors of the primary and/or secondary outcomes were age, history of non‐cardiovascular syncope, valve disease, anaemia, lower sodium, and higher potassium, but no cardiovascular co‐morbidities. Renin–angiotensin system antagonist and mineralocorticoid receptor antagonist use predicted improved prognosis.
Conclusion
HFPEF was associated with higher age, female gender, hypertension, atrial fibrillation/flutter, and numerous non‐cardiovascular co‐morbidities. Prognosis was determined by non‐cardiovascular co‐morbidities, but use of conventional heart failure medications may still be associated with improved outcomes.
Cardiac resynchronization therapy (CRT) decreases mortality, improves functional status, and induces reverse left ventricular remodeling in selected populations with heart failure. We aimed to assess ...the impact of baseline QRS duration and morphology and the change in QRS duration with pacing on CRT outcomes in mild heart failure.
Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) was a multicenter randomized trial of CRT among 610 patients with mild heart failure. Baseline and CRT-paced QRS durations and baseline QRS morphology were evaluated by blinded core laboratories. The mean baseline QRS duration was 151±23 milliseconds, and 60.5% of subjects had left bundle-branch block (LBBB). Patients with LBBB experienced a 25.3-mL/m(2) mean reduction in left ventricular end-systolic volume index (P<0.0001), whereas non-LBBB patients had smaller decreases (6.7 mL/m(2); P=0.18). Baseline QRS duration was also a strong predictor of change in left ventricular end-systolic volume index with monotonic increases as QRS duration prolonged. Similarly, the clinical composite score improved with CRT for LBBB subjects (odds ratio, 0.530; P=0.0034) but not for non-LBBB subjects (odds ratio, 0.724; P=0.21). The association between clinical composite score and QRS duration was highly significant (odds ratio, 0.831 for each 10-millisecond increase in QRS duration; P<0.0001), with improved response at longer QRS durations. The change in QRS duration with CRT pacing was not an independent predictor of any outcomes after correction for baseline variables.
REVERSE demonstrated that LBBB and QRS prolongation are markers of reverse remodeling and clinical benefit with CRT in mild heart failure.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00271154.
Aims
The Cardiac Resynchronization‐Heart Failure (CARE‐HF) study helped establish an important role for cardiac resynchronization therapy (CRT) in the management of selected patients with heart ...failure. We now report the long‐term outcome during and subsequent to the randomized trial.
Methods and results
Enrolment was completed in March 2003. After reporting the main study results in 2005, investigators were asked to inform patients of the results and implant a CRT device if still appropriate. Subsequently, investigators were asked to consent patients for long‐term follow‐up until 30 September 2009. Of 813 patients originally enrolled, 343 (42%) died prior to re‐consent, 111 patients (14%) were not or could not be contacted, 50 (6%) were alive but declined to participate, and 309 (38%) consented to long‐term follow‐up. Of patients originally assigned to the control group, > 95% of survivors had received CRT by the time of re‐consent. From the time of randomization, 222 patients originally assigned to pharmacological therapy and 192 originally assigned to CRT were known to have died. The hazard ratio for mortality in patients originally assigned to CRT compared with those originally assigned to the control group was 0.77 (95% confidence interval 0.63–0.93; P = 0.007). No subgroup interactions were observed.
Conclusion
The effect of CRT on mortality observed during the randomized CARE‐HF trial persisted during long‐term follow‐up. A high rate of CRT device implantation in the control group after completion of the randomized phase of the study may have prevented further divergence of the survival curves.
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