2010 Focused Update of ESC Guidelines on device therapy in heart failure

Abstract

atrial fibrillation atrio-ventricular Committee for Practice Guidelines cardiac resynchronization therapy CRT with pacemaker function CRT with defibrillator function cardiac transplantation cardiovascular European Heart Rhythm Association European Society of Cardiology heart failure Heart Failure Association hospitalization implantable cardioverter defibrillator left bundle branch block left ventricular left ventricular assist device left ventricular end-diastolic diameter left ventricular ejection fraction left ventricular stroke volume index left ventricular end-systolic volume 6 min walk test not applicable National Institutes of Health not significant New York Heart Association optimal medical therapy peak oxygen consumption quality of life right bundle branch block randomized clinical trial sinus rhythm ventilation/carbon dioxide ratio The Committee for Practice Guidelines (CPG) of the European Society of Cardiology recognizes that new evidence from clinical research trials may impact on current recommendations. The current heart failure (HF) guidelines1 were published in 2008 and the cardiac pacing guidelines in 2007.2 In order to keep these guidelines up to date, it would be appropriate to modify the recommendations and levels of evidence according to the most recent clinical trial evidence. This Focused Update on the use of devices in heart failure 2010 is the first publication of its kind from the CPG. Practice Guideline recommendations should represent evidence-based medicine. Traditionally, these recommendations are based on the outcomes in the cohort of patients described by the inclusion criteria in the protocols of randomized clinical trials (RCTs). More recently, based on the fact that the characteristics of the patients actually included in a trial may differ substantially from the eligibility criteria, Guideline Task Force members frequently favour restricting the applicability of these recommendations to the clinical profile and outcomes of the enrolled cohort, representing a more accurate interpretation of the evidence provided by a trial's result. In contrast to previous guidelines, this focused update considers the characteristics of the patients included in the trials and contains several examples. In MADIT-CRT, although the protocol permitted inclusion of patients in both New York Heart Association (NYHA) I and II function class, only 15% of the patients included in this trial were classified as NYHA I, many of whom had been previously symptomatic. Similarly, although the inclusion criteria permitted randomization of patients with a QRS width of ≥130 m, the favourable effect on the primary endpoint was limited to patients with a QRS width of ≥150 ms, a prospective, pre-specified cut-off. The text accompanying these recommendations explains and justifies the decisions to diverge from a traditional recommendation based strictly on the protocol inclusion criteria. The Task Force hopes that the users of the Guidelines will appreciate that this adjustment provides a more realistic application of the trial evidence to daily clinical practice. The management of patients with HF represents a substantial economic burden and hospitalization is responsible for >50% of this expense.3 The initial expense of device implantation must be weighed against measures of short- and long-term efficacy with regard to survival, morbidity, and quality of life.4 The effective use of limited health care resources necessitates identification of the characteristics of the patient population most likely to benefit from cardiac resynchronization therapy (CRT) and treatment strategy should target these patients for device implantation. The clinical effects of long-term CRT have been evaluated in a large number of randomized multi-centre trials with crossover or parallel treatment assignment,5–11 using CRT pacemakers (CRT-P) or CRT-implantable cardioverter defibrillator (ICD) devices (CRT-D). Practice with regard to the choice of the CRT device varies widely between countries.4 Meta-analyses were also published,12–15 suggesting that the most efficacious option in patients with HF and low left ventricular ejection fraction (LVEF) would be a CRT-D. The usual study enrolment criteria were: NYHA function class III or IV despite optimal pharmacological treatment, LVEF ≤35%, sinus rhythm (SR), left ventricular (LV) dilatation but with varying definitions, and QRS duration ≥120/ ≥ 130 ms. All RCTs have confirmed a significant alleviation of symptoms and increase in exercise capacity conferred by CRT. On average, NYHA function class decreased by 0.5–0.8 points, the 6 min walk distance increased by 20%, and peak oxygen consumption increased by 10–15%. The functional benefits and quality of life improvements were sustained.11,16,17 In the COMPANION trial, CRT with or without an ICD, lowered the combined endpoint of all-cause mortality and rehospitalization for HF by 35–40%, mainly driven by the 76% lower rate of hospitalization