Source: DGNews  |  Posted 3 years ago

By Chris Berrie

MILAN, Italy -- June 18, 2008 -- Cardiac resynchronisation therapy with or without an implantable cardioverter defibrillator (CRT+/–ICD) is a safe and effective therapy in patients with advanced heart failure (HF) who are refractory to optimal therapy, according to a long-term study presented here at the Heart Failure 2008 (HF2008) Congress.

Although it is known that CRT+/–ICD has short-term benefits in patients with advanced HF that is refractory to optimal treatment, this study is the first to demonstrate the long-term effects of this therapy, said principal investigator Natalia Pezzali, MD, Section for Cardiovascular Diseases, Department of Experimental and Applied Medicine, University Hospital, Brescia, Italy.

In their study, Dr. Pezzali and colleagues evaluated the long-term effects of CRT+/–ICD on patients' clinical characteristics and on the incidence of all-cause mortality, sudden cardiac death, and death for heart failure, she said in a poster presentation on June 16.

Patients in the study had advanced HF, defined as New York Heart Association (NYHA) class III/IV, despite optimised medical therapy. The patients also had left ventricular ejection fraction (LVEF) <35%, QRS >150 ms or >200 ms among conventional pacemaker carriers.

In all, the study evaluated 268 men and 81 women (mean age, 69 years) with stable clinical conditions. An ICD was implanted in 185 pts (53%); 128 received CRT with a pacing device (CRT-P), and 221 received CRT with a defibrillator device (CRT-D). At implantation, 83.5% of the patients were in sinus rhythm, with the remainder in permanent atrial fibrillation.

Patient assessments were carried out at recruitment and every 6 months following CRT+/–ICD implantation, including 12-lead electrocardiogram (ECG) and echocardiogram, or multiple gated acquisition assessment of LV function. All patients received optimal medical treatment for advanced HF.

After 4 years of follow-up, with 67.2% survival, patients showed significant benefits over recruitment baseline, with improvements in NYHA class (3.1 vs 2.0; P < .0001), rate of hospitalisation for worsening HF (2.7 vs 0.2 per year; P < .0001), cardiovascular hospitalisations (2.4 vs 0.46 per year; P < .0001), and days in hospital (35.4 vs 5.4 per year; P < .0001).

Mortality rate was significantly lower among CRT-D patients compared with CRT-P patients (5.0% vs 31.2%; P < .01), and the same was the case with rates of sudden cardiac death (3% vs 14%; P < .001).

The researchers concluded that CRT+/–ICD as a treatment option for these patients with advanced HF is both safe and effective. "With time, we have a progressive improvement in prognosis," Dr. Pezzali emphasised.

"This [study] tells us that also in the long term we have a significant benefit both in the clinical status and in the prognosis with CRT+/–ICD in heart failure patients," she said.

[Presentation title: The Long-Term Effects of Cardiac Resynchronisation Therapy +/– Implantable Defibrillator (CRT+/–ICD). Abstract P713]