Commentary: Use of registries to investigate the past and develop the future.

International audienceIdeally, collection of clinical data should be an integral part of healthcare systems. Without systematic collection of individual patient data and outcome it is impossible for individual doctors, healthcare providers, or regulatory agencies to understand how, when, and to whom healthcare is provided and the actual outcome of specific procedures or devices..

The effect of cardiac resynchronization on morbidity and mortality in heart failure

Background: Cardiac resynchronization reduces symptoms and improves left ventricular function in many patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony. We evaluated its effects on morbidity and mortality. Methods: Patients with New York Heart Association class III or IV heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony who were receiving standard pharmacologic therapy were randomly assigned to receive medical therapy alone or with cardiac resynchronization. The primary end point was the time to death from any cause or an unplanned hospitalization for a major cardiovascular event. The principal secondary end point was death from any cause. Results: A total of 813 patients were enrolled and followed for a mean of 29.4 months. The primary end point was reached by 159 patients in the cardiac-resynchronization group, as compared with 224 patients in the medical-therapy group (39 percent vs. 55 percent; hazard ratio, 0.63; 95 percent confidence interval, 0.51 to 0.77; P<0.001). There were 82 deaths in the cardiac-resynchronization group, as compared with 120 in the medical-therapy group (20 percent vs. 30 percent; hazard ratio 0.64; 95 percent confidence interval, 0.48 to 0.85; P<0.002). As compared with medical therapy, cardiac resynchronization reduced the interventricular mechanical delay, the end-systolic volume index, and the area of the mitral regurgitant jet; increased the left ventricular ejection fraction; and improved symptoms and the quality of life (P<0.01 for all comparisons). Conclusions: In patients with heart failure and cardiac dyssynchrony, cardiac resynchronization improves symptoms and the quality of life and reduces complications and the risk of death. These benefits are in addition to those afforded by standard pharmacologic therapy. The implantation of a cardiac-resynchronization device should routinely be considered in such patients

Interplay between right ventricular function and cardiac resynchronization therapy : an analysis of the CARE-HF trial (cardiac resynchronization–heart failure)

Objectives: The aim of this study was to investigate the impact of cardiac resynchronization therapy (CRT) on right ventricular (RV) function and the influence of RV dysfunction on the echocardiographic and clinical response to CRT among patients enrolled in the CARE-HF (Cardiac Resynchronization-Heart Failure) trial. Background: Cardiac resynchronization therapy prolongs survival in appropriately selected patients with heart failure but the benefit might be diminished in patients with RV dysfunction. Methods: Of 813 patients enrolled in the CARE-HF study, 688 had tricuspid plane systolic excursion (TAPSE) measured at baseline, and 345 of these were assigned to CRT. Their median (interquartile range) age was 66 (58 to 71) years, left ventricular (LV) ejection fraction was 24% (21% to 28%), and TAPSE was 19 (16 to 22) mm. Baseline LV function and size and QRS duration were similar among TAPSE tertiles, but those in the worst tertile (TAPSE < 17.4 mm) were more likely to have ischemic heart disease. Results: Overall, CRT improved LV but not RV structure and function with little evidence of an interaction with TAPSE. During a median (interquartile range) follow-up of 748 (582 to 950) days, 213 deaths occurred. Patients with lower TAPSE had a higher mortality, regardless of assigned treatment (p < 0.001). Greater inter-ventricular mechanical delay, New York Heart Association functional class, mitral regurgitation, and N-terminal pro-B-type natriuretic peptide, lower TAPSE, and assignment to the control group were independently associated with higher mortality. Reduction in mortality with CRT was similar in each tertile of TAPSE. Conclusions: Right ventricular dysfunction is a powerful determinant of prognosis among candidates for CRT, regardless of treatment assigned, but did not diminish the prognostic benefits of CRT among patients enrolled in the CARE-HF trial. (Care-HF CArdiac Resynchronization in Heart Failure; NCT00170300) © 2013 American College of Cardiology Foundation

085: Heart failure with preserved ejection fraction: changes in clinical parameters between acute presentation and subsequent follow-up

PurposeIn the prospective KaRen registry of heart failure with preserved ejection fraction (HFPEF), changes in clinical and biological parameters and medications were assessed between acute presentation and out-patient follow-up in stable state.MethodsThe KaRen study included patients presenting with acute heart failure (HF) according to inclusion criteria: Framingham criteria for HF, left ventricular ejection fraction > or=45% and brain natriuretic peptide (BNP)>100pg/mL or NT-proBNP>300pg/mL. Once stabilized, 4-8 weeks after the index presentation, patients returned as out-patients for repeat assessment. Changes in clinical and biological parameters and medications between inclusion and follow-up were assessed with Students t-test and Chi-square testsResults577 patients were recruited and 458 returned for the 4-8 weeks visit. 56% were women. The median [25-75pctl] age was 79 [72-84] years. Medical history included 78% hypertension, 58% atrial arrhythmia, 26% type II diabetes and 27% serum creatinin >100 micromol/l. The table provides inclusion and follow-up dataConclusionsPatients presenting with HFPEF are elderly and a majority are women, with a high rate of hypertension and atrial arrhythmias. Blood pressure is incompletely controlled. At follow-up, blood pressure and NT-proBNP were reduced, but patients remain symptomatic. Still, efforts are needed to improve symptoms in HFPEF.Table (abstract 85) – Inclusion and follow-up data.Variable Mean (IQR)NYHA I / II / III / IVSBPCreatinineNT-proBNPACEI /ARBB-blockerANTICOAGInclusion0.8 / 9.4 / 40 / 49.8%148 [130-170]93 [74-128]2433 [1272-4790]60%65%41%Follow-up13 / 62.5 / 22.2 / 2.3140 [120-150]95 [75-129]1409 [514-2641]68%67.5%51.3%p<0.00010.003<0.000

073: Very long-term effects of pacing therapy in Hypertrophic Obstructive Cardiomyopathy (HOCM)

The clinical value of DDD pacing as primary treatment of HOCM remains controversial. Very long-term data are lacking.Aimssingle-centre observational study aimed at describing the very long term effects on symptoms, clinical and echocardiographic outcomesPatients54 patients (59±14 years) with symptomatic (NYHA Class >2) drug-refractory HOCM implanted with a DDD pacemaker with or without defibrillator between 1991 and 2007 and followed up to 20 years (mean 11.5; range 0,4-21,8).Main resultsare summarised in table. No patient had myomectomy or septal ablation during follow-up (f/u). NYHA functional class and other symptoms were significantly improved at 1-2 years and at the end of f/u. Left ventricular outflow tract (LVOT) gradient decreased by a mean of 78% at 1-2 years and 89% at end f/u consistent with SAM resolution. LV ejection fraction decreased over time with a mean value of 56% at end f/u without evidence of cavity dilatation. The actuarial survival rate was 90% at 5-yrs and 65% at 10-yrs. 24 patients died, 19 from non cardiac cause and 5 cardiovascular. 2 patients had heart transplant after 8 and 13yrs.ConclusionThe clinical and echocardiographic outcome of HOCM patients treated by DDD pacing seems favourable, inviting to re-evaluate the exact value of the therapy in further controlled studiesTable – Main results.Baseline3 months1-2 yearsEnd f/uP valueNYHA functional class, (%)<0,0001Grade 10313536Grade 243535957Grade 3521667Grade 45000Syncope/nearsyncope (%)76/482/22/22/2<0,0001Angina (%)57444<0,0001LVOT gradient (mmHg)79±3620±2411±158±21<0,0001SAM (%)96383016<0,0001LVEF (%)63,5±7,561±759±756±90,05LVEDD (%)47±5NANA43±120,3

Effect of QRS duration and morphology on cardiac resynchronization therapy outcomes in mild heart failure: results from the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) study.

International audienceBACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSION: REVERSE demonstrated that LBBB and QRS prolongation are markers of reverse remodeling and clinical benefit with CRT in mild heart failure. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00271154

The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta-analysis of COMPANION and CARE-HF

AIMS: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality for patients with heart failure, reduced left ventricular ejection fraction, QRS duration >130 ms and in sinus rhythm. The aim of this study was to identify patient characteristics that predict the effect, specifically, of CRT pacemakers (CRT-P) on all-cause mortality or the composite of hospitalization for heart failure or all-cause mortality. METHODS AND RESULTS: We conducted an individual patient data meta-analysis of the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) and Cardiac Resynchronization-Heart Failure (CARE-HF) trials. Only patients assigned to CRT-P or control (n = 1738) were included in order to avoid confounding from concomitant defibrillator therapy. The influence of baseline characteristics on treatment effects was investigated. Median age was 67 (59-73) years, most patients were men (70%), 68% had a QRS duration of 150-199 ms and 80% had left bundle branch block. Patients assigned to CRT-P had lower rates for all-cause mortality (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.56-0.81; p < 0.0001) and the composite outcome (HR 0.67, 95% CI 0.58-0.78; p < 0.0001). No pre-specified characteristic, including sex, aetiology of ventricular dysfunction, QRS duration (within the studied range) or morphology or PR interval significantly influenced the effect of CRT-P on all-cause mortality or the composite outcome. However, CRT-P had a greater effect on the composite outcome for patients with lower body surface area and those prescribed beta-blockers. CONCLUSIONS: Cardiac resynchronization therapy-pacemaker reduces morbidity and mortality in appropriately selected patients with heart failure. Benefits may be greater in smaller patients and in those receiving beta-blockers. Neither QRS duration nor morphology independently predicted the benefit of CRT-P. CLINICAL TRIAL REGISTRATION: COMPANION, NCT00180258; CARE-HF, NCT00170300

A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial)

International audienceAIMS: 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. METHODS AND RESULTS: 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. CONCLUSION: 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