Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study.

BACKGROUND: There's scarce evidence about cardiovascular events (CV) in patients with hospitalization for acute heart failure (HF) and no indication for immediate device implant. OBJECTIVE: The CARdiac RhYthm monitorING after acute decompensatiON for Heart Failure study was designed to assess the incidence of prespecified clinical and arrhythmic events in this patient population. METHODS: In this pilot study, 18 patients (12 (67%) male; age 72±10; 16 (89%) NYHA II-III), who were hospitalized for HF with low left ventricular ejection fraction (LVEF) (<40%) and no immediate indication for device implant received an implantable loop recorder (ILR) before hospital discharge. Follow-up visits were scheduled at 3 and 6 months, and at every 6 months until study closure; device data were remotely reviewed monthly. CV mortality, unplanned CV hospitalization, and major arrhythmic events during follow-up were analyzed. RESULTS: During a median follow-up of 593 days, major CV occurred in 13 patients (72%); of those, 7 patients had at least 1 cardiac arrhythmic event, 2 had at least a clinical event (CV hospitalization or CV death), and 4 had both an arrhythmic and a CV event. Six (33%) patients experienced 10 major clinical events, 5 of them (50%) were HF related. During follow-up, 2 (11%) patients died due to a CV cause and 3 (16%) patients received a permanent cardiac device. CONCLUSIONS: After an acute HF hospitalization, patients with LVEF<40% and who are not readily eligible for permanent cardiac device implant have a known high incidence of major CV event. In these patients, ILR allows early detection of major cardiac arrhythmias and the ability to react appropriately in a timely manner. TRIAL REGISTRATION: ClinicalTrials.gov NCT01216670; https://clinicaltrials.gov/ct2/show/NCT01216670.

Women with nonischemic cardiomyopathy have a favorable prognosis and a better left ventricular remodeling than men after cardiac resynchronization therapy.

AIMS: Cardiac resynchronization therapy (CRT) is a well established therapy in heart failure patients who are on optimal medical therapy and have reduced left ventricular ejection fraction (LVEF) and wide QRS complexes. Although women and patients with nonischemic cardiomyopathy are under-represented in CRT trials and registries, there is evidence that these two groups of patients can benefit more from CRT. The aim of our analysis was to investigate the impact of female sex on mortality in a population that included a high percentage of patients (61%) with nonischemic cardiomyopathy. METHODS: We analyzed data on 507 consecutive patients (20% women) who received CRT at two Italian Heart Transplant centers and were followed up for a maximum of 48 months. RESULTS: After multivariate adjustment, women showed a trend toward better survival with regard to all-cause mortality [hazard ratio (HR) 0.32, confidence interval (CI) 0.10-1.04; P = 0.059]. However, this benefit was limited to nonischemic patients with regard to all-cause mortality (HR 0.20, CI 0.05-0.87, P = 0.032) and cardiovascular mortality (HR 0.14, CI 0.02-1.05, P = 0.056). CONCLUSION: Female CRT recipients, at mid-term, have a favorable prognosis than male patients and this benefit appears to be more evident in nonischemic patients. Thus, we strongly believe that the apparent under-utilization of CRT in females is an anomaly that should be corrected.

Left ventricular ejection fraction overcrossing 35% after one year of cardiac resynchronization therapy predicts long term survival and freedom from sudden cardiac death: single center observational experience.

BACKGROUND: Reverse remodeling and increased LVEF after CRT correlate with survival and heart failure hospitalizations, but their relationship with the risk of SCD is unclear. We aimed to evaluate whether exceeding a threshold value of 35% for left ventricular ejection fraction (LVEF) 1 year after cardiac resynchronization therapy (CRT) predicts survival and freedom from sudden cardiac death (SCD). METHODS: 330 patients who survived ≥ 6 months after CRT (males 80%, age 62 ± 11 years) were grouped according to 1-year LVEF ≤ 35% (Group 1, n=187, 57%) or >35% (Group 2, n=143, 43%). According to changes vs. baseline (reduction of left end-systolic volume [LVESV] ≥ 10% or increase of LVEF% > 10 units), patients were also classified as echocardiographic (Echo) non-responders (Group A, n=152, 46%) or responders (Group B, n=178, 54%). RESULTS: At baseline, LVESV volume was larger and LVEF was lower in Group 1 vs. Group 2 (p<0.001). After 1 year, echocardiographic improvement was greater in Group 2 vs. Group 1 (p<0.001 for changes in both LVESV and LVEF). Over a median follow-up of 49 months, 47 patients (14%) died, 36 in Group 1 vs. 11 in Group 2 (19% vs. 8%, p=0.004). A significantly higher rate of freedom from all-cause mortality (p=0.002), cardiovascular mortality (p<0.001) and SCD (p<0.001) was observed in Group 2. Multivariate analysis demonstrated that only 1-year LVEF >35% was associated with freedom from SCD/VF. CONCLUSIONS: LVEF >35% after 1 year of CRT characterizes a favorable long-term outcome, with a very low risk for SCD.

[Cardiac resynchronization therapy in women]. / La terapia di resincronizzazione cardiaca nella donna.

Cardiac resynchronization therapy (CRT) is a well established option in patients with moderate to severe heart failure on optimal medical therapy, NYHA functional class Ill-IV, reduced systolic function (left ventricular ejection fraction < or =35%), broad QRS complex (>120 ms), but data addressing sex differences in response to CRT are lacking. Women are underrepresented in clinical and observational trials on CRT (<30%) but, when examining response across recent studies, there is evidence of a more positive effect of CRT in women. Also our data show that females seem to achieve a greater survival benefit with CRT than male recipients. While larger trials remain the ideal way to specifically address the question of a gender effect, with some uncertainties on the understanding of the greater benefit still present (specific factors intrinsic to women are responsible for this difference? pre-CRT clinical characteristics, prevalence of nonischemic cardiomyopathy and left bundle branch block, other than female gender itself?), current evidence supports the notion of increasing access to CRT for women with the appropriate indication, to allow them to exploit the distinctive benefits associated with this treatment strategy.

CArdiac resynchronization in combination with beta blocker treatment in advanced chronic heart failure (CARIBE-HF): the results of the CARIBE-HF study.

OBJECTIVE: Cardiac resynchronization therapy (CRT), combined with optimal medical therapy (OMT), is an established treatment for patients with advanced chronic heart failure (ACHF). In ACHF, carvedilol at the dose used in clinical trials, reduces morbidity and mortality. However, patients often do not tolerate the drug at the targeted dosage. The aim of the CARIBE-HF prospective observational study was to investigate the role of CRT in the implementation of carvedilol therapy in patients with ACHF. METHODS: One hundred and six patients (aged 65 12 [mean +/- SD] years) with ACHF were enrolled and treated with OMT, in which carvedilol was titrated up to the maximal dose (phase 1). Subsequently, patients with left ventricular (LV) ejection fraction < or = 35%, NYHA class III-IV and QRS interval > or =120 msec were assigned to CRT. Both CRT and NO-CRT patients underwent a long-term follow-up of 7 years (1193.98 +/- 924 days), while efforts to up titrate the carvedilol dose were continued during the second phase (471 + 310 days). Phase 1 was completed by 84 patients (79%), and 15 (18%) underwent CRT. The mean carvedilol dose in the CRT group was 19.0 +/- 17.8 mg, against 32.7 +/- 19.1 mg in the remaining 69 patients (P = 0.018). At the end of phase 2, CRT patients presented a significantly greater variation of increasing in the carvedilol dose than NO-CRT patients (+20.0 +/- 19.8 mg vs. -0.3 +/- 20.5 mg; P = 0.015), a greater NYHA class reduction (-0.8 +/- 0.6 vs. -0.2 +/- 0.7; P = 0.011), and a greater increase in LV ejection fraction (10.8 +/- 9 vs. 3.1 +/- 6.1; P = 0.018). CONCLUSIONS: The data from the CARIBE study suggest that, in ACHF, CRT may be effective in enabling the target dose of carvedilol to be reached. The significant improvement seen in LV function was probably due to a synergistic effect of CRT and carvedilol. During the extended follow-up (mean 1193.98 +/- 924 days) the mean dosage of carvedilol in the CRT group was significantly higher (P < 0.02).

Diagnostic capabilities of devices for cardiac resynchronization therapy.

Atrial fibrillation and chronic heart failure often coexist. Asymptomatic atrial fibrillation is common in patients with known atrial fibrillation but also in patients with no history of previous atrial fibrillation. The enhanced diagnostic capabilities of modern implantable devices for cardiac resynchronization therapy allow collecting of data on the clinical status of the patient in addition to information on device performance and cardiac rhythm. We present a paradigmatic case of newly diagnosed atrial fibrillation with hemodynamic consequences detected by the diagnostics of a biventricular implantable cardioverter-defibrillator. We discuss the clinical utility of device-based monitoring and the potential advantages of wireless remote-control systems of implantable devices in the management of heart failure patients.