Clinical trials update from the American Heart Association Meeting 2010: EMPHASIS-HF, RAFT, TIM-HF, Tele-HF, ASCEND-HF, ROCKET-AF, and PROTECT

This article provides information and a commentary on key trials relevant to the pathophysiology, prevention, and treatment of heart failure presented at the annual meeting of the American Heart Association held in Chicago in 2010. Unpublished reports should be considered as preliminary, since analyses may change in the final publication. In patients with mild heart failure (HF), EMPHASIS-HF showed that the addition of eplerenone to standard therapy was well tolerated and reduced both the risk of death and hospitalization. The addition of cardiac resynchronization therapy to implantable cardioverter defibrillator (ICD) therapy reduced the incidence of all-cause mortality and HF hospitalizations in patients with NYHA class IIIII HF compared with ICD alone in RAFT. Telemonitoring failed to improve outcome compared with a high standard of conventional care in patients with chronic HF (TIM-HF study) and a telephone-based interactive voice response system failed to improve outcome in patients recently hospitalized for HF (Tele-HF study). ASCEND-HF suggested that nesiritide was ineffective but safe in patients with acute decompensated HF. ROCKET-AF suggests that the factor-Xa inhibitor rivaroxaban may be as effective as warfarin in patients with atrial fibrillation. The PROTECT study provided more data to suggest that amino-terminal B-type natriuretic peptide guided therapy may be beneficial in patients with left ventricular systolic dysfunction

Does the physical examination still have a role in patients with suspected heart failure?

AIMS: The prognostic value of signs of congestion in patients suspected of having chronic heart failure (CHF) is unknown. Our objectives were to define their prevalence and specificity in diagnosing CHF and to determine their prognostic value in patients in a community heart failure clinic. METHODS AND RESULTS: Analysis of referrals to a community clinic for patients with CHF symptoms. Systolic CHF (S-HF) was defined as left ventricular ejection fraction (LVEF) </=45%, heart failure with normal ejection fraction (HeFNEF) as LVEF > 45%, and amino-terminal pro-brain natriuretic peptide >50 pmol L(-1); other subjects were defined as not having CHF. Signs of congestion were as follows: no signs; right heart congestion (RHC: oedema, jugular venous distension); left heart congestion (LHC: lung crackles); or both (R + LHC). Of 1881 patients referred, 707 did not have CHF, 853 had S-HF, and 321 had HeFNEF. The median inter-quartile range (IQR) age was 72 years (64-78), 40% were women, and LVEF was 47% (35-59). Overall, 417 patients had RHC of whom 49% had S-HF and 21% HeFNEF. Eighty-five patients had LHC of whom 43% had S-HF and 20% had HeFNEF. One hundred and seventy-two patients had R + LHC of whom 71% had S-HF and 16% had HeFNEF. During a median (IQR) follow-up of 64(44-76) months, 40% of the entire patient cohort died. The combination of R + LHC signs was an independent marker of an adverse prognosis (chi(2)-log-rank test = 186.1, P< 0.0001). CONCLUSION: Clinical signs of congestion are independent predictors of prognosis in ambulatory patients with suspected CH

The European CRT Survey: 1 year (9-15 months) follow-up results

Aims: The European CRT Survey is a joint initiative of the Heart Failure Association (HFA) and the European Heart Rhythm Association (EHRA) of the European Society of Cardiology evaluating the contemporary implantation practice of cardiac resynchronization therapy (CRT) in Europe. Methods and results: Patients who had a successful CRT implantation were enrolled from 141 centres in 13 countries between November 2008 and June 2009. Baseline demographics, clinical and implantation data were collected, with a follow-up of ∼1 year (9–15 months). The current report describes clinical outcomes including symptom severity, cardiovascular (CV) hospitalization, and survival. A total of 2438 patients were enrolled, and follow-up data were acquired from 2111 patients (87%). The population included important groups of patients poorly represented in randomized controlled trials, including very elderly patients and those with prior device implantation, atrial fibrillation, and/or QRS duration <120 ms. Investigators reported substantial improvement in New York Heart Association (NYHA) functional class at follow-up. Patient self-assessment indicated that 81% of the patients felt improved, 16% reported no change, and 4% reported deterioration. During follow-up, 207 (10%) patients died, 346 (16%) had a CV hospitalization, and 501 (24%) died or had CV hospitalization. Worse NYHA functional class, atrial fibrillation, ischaemic aetiology, and device type (CRT-P, i.e. CRT alone) were associated with poorer survival. Women had a better outcome, as did patients who had a CRT-D (with an implantable cardioverter defibrillator function) device. Conclusions: Outcomes including death and hospitalization in this European CRT survey were consistent with results from clinical trials of CRT. At 1 year follow-up, most patients who received a CRT device considered their symptoms improved compared with their pre-implant assessment. Although prospective, this is an observational study of successful CRT implantations, and outcomes in subgroup analyses must be interpreted with appropriate conservatism. Clinical study no: NCT 01185392