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Clinical Articles, Lead Article

CRT comes of age

Cardiac resynchronisation therapy (CRT) reduces rates of death and re-hospitalisation among heart failure patients according to the European CRT Survey, follow-up results from which were published recently in the European Journal of Heart Failure.1

The survey – a joint initiative of the Heart Failure Association  and European Heart Rhythm Association of the European Society of Cardiology (ESC) – gathered information on more than 2,000 patients at 141 centres in 13 European countries. Its aim was to assess the effect of cardiac resynchronisation therapy (CRT) on symptom severity, cardiovascular re-hospitalisation, and survival.

The study population included subjects poorly represented in clinical trials but commonly admitted as heart failure patients – including the very elderly, those with atrial fibrillation (AF), and those previously treated with a pacemaker or other cardiac device.

Analysis of the survey data showed that at, one year (average) follow-up, 81% reported a self-assessed improvement in their symptoms (with 16% no change and 4% a deterioration).  The survey also found that almost 25% of the subjects had died or been re-hospitalised within the 12-month follow-up period.  Patients implanted with a pacing device only (CRT-P) had higher rates of mortality than those whose device had an additional defibrillator (CRT-D).

First author Dr Nigussie Bogale (Stavanger University Hospital, Norway) said: “This is the largest study reporting a difference in outcome between CRT-D and CRT-P. Most patients with an indication for CRT have also an indication for a defibrillator. So unless they have contraindicating co-morbidities, it is now our belief that these patients should be considered for CRT-D implantation”.

And also…

FDA advisory panel approves Medtronic CRT-Ds

Michael R. Gold, M.D., Ph.D

Michael R. Gold, M.D., Ph.D

The overall clinical benefits of Medtronic cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices outweigh the risks in treating certain mildly symptomatic heart failure patients, according to a recent determination from the US Food and Drug Administration’s (FDA) Circulatory Systems Devices Advisory Panel.

The recommendation was based on data from the RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) and REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) clinical trials. While the CRT-Ds are currently approved for patients with moderate-to-severe heart failure, these studies found that their use could benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalisation rates.

The Advisory Panel voted in favor of the CRT-D devices’ safety (Yes: 5 votes, No: 0 votes) and efficacy (Yes: 3 votes, No: 2 votes) profile in treating a mildly symptomatic patient population. The panel voted in favor of the overall risk-benefit profile (Yes: 3 votes and No: 2 votes)

The FDA will consider the Panel’s feedback as it reviews Medtronic’s request to expand its CRT-D indication to include New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30%, left bundle branch block (LBBB), and a QRS duration greater than or equal to 120 milliseconds.

“We look forward to working closely with the FDA during the regulatory process so that we may expand the use of our innovative portfolio of CRT-D devices in an effort to enhance patient outcomes in a broader heart failure population,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic.

“As was seen in the RAFT and REVERSE trials, clinical evidence demonstrates that CRT-D prevents hospitalization and can save lives in mildly symptomatic patients,” said Dr Michael R Gold, REVERSE study investigator and steering committee member (Medical University of South Carolina). “Utilizing this lifesaving therapy earlier in a milder heart failure population would allow us to treat these patients before their symptoms exacerbate, ultimately enabling us to better address this serious, often debilitating and costly disease”.

RAFT Clinical Trial

Findings from the landmark RAFT clinical trial, published in the New England Journal of Medicine, showed that CRT-D significantly reduced mortality for mildly symptomatic heart failure patients (NYHA Class II) by 29% when compared to patients treated with guideline-recommended implantable ICDs and medical therapy. The study also demonstrated a significant reduction (27%) in combined mortality and heart failure hospitalizations for this population, consistent with previously published studies. All patients were followed for at least 18 months, and had an average follow-up of 40 months, making it the longest follow-up and largest patient months-of-experience of any study of CRT therapy.

REVERSE Clinical Trial

With 610 patients studied, REVERSE was the first large-scale, global, randomised, double-blind trial to demonstrate the impact of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms. All of the randomised subjects received a Clinical Composite Response at 12 months. The Clinical Investigation Plan pre-specified that a comparison would be made between subjects with CRT and those without. The results showed that 21% of subjects without CRT worsened, compared with 16% with CRT.

In a post-hoc analysis, more patients in the trial improved with CRT than without (54% vs. 40%, respectively). The Clinical Composite Response measure for heart failure consists of several different endpoints, including death, hospitalisation for heart failure, crossover to the opposite arm due to worsening heart failure, a progression to a worsened NYHA class, or a moderate or marked worsening of the patient’s self-assessment (administered by the blinded clinician).

Furthermore, the analysis of secondary endpoints in the REVERSE trial showed that CRT leads to improvement in both cardiac structure and function as measured by echocardiography, meaning the heart size improves and beats more effectively. In an additional analysis, REVERSE also demonstrated that CRT delayed the time to first heart failure hospitalisation in this patient group and reduced hospitalisation or death by 51%.

References

1 Bogale N, Priori S, Cleland JGF, et al. The european CRT survey: 1 year (9-15 months) follow-up results.  Eur J Heart Fail 2011; doi:10.1093/eurjhf/hfr158.

Published on: January 10, 2012

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