A Medical Device Daily

In new medical guidance for England and Wales, the National Institute for Clinical Excellence (NICE; Watford, England) is promoting the expanded use of dual-chamber pacemakers for treating slow heart rhythms, or bradycardia, suffered by an estimated 100,000 UK residents.

NICE advises in its latest guidance that up to 90% of all pacemakers implanted to treat sick sinus syndrome and atrioventricular block – the two primary causes of bradycardia – should be dual-chamber devices delivering electrical impulses to both the right atrium and the right ventricle. Currently 60% of roughly 26,000 pacemakers implanted yearly in the UK are dual-chamber devices; the other 40% are single-chamber devices, which usually stimulate only the right ventricle.

"NICE rightly recognizes that dual-chamber pacemakers improve clinical outcomes cost-effectively for the treatment of bradycardia associated with sick sinus syndrome and atrioventricular block," said cardiologist Prof. Richard Sutton, a consultant with the Royal Brompton Hospital (London). "This new guidance is based on an exhaustive review of the medical literature on the subject and should encourage specialists in heart rhythm disorders to implant a greater proportion of dual-chamber devices for patients suffering from this type of arrhythmia."

According to the guidance, titled "Dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome and/or atrioventricular block," NICE estimates that the cost to the NHS of implementing these recommendations will range from £8 million to £10 million per year, an investment that the assessment committee deemed cost-effective.

"Dual-chamber pacemakers are well worth the extra cost," Sutton said. "The incremental cost-effectiveness ratio developed by NICE, at £8,500 per quality-adjusted life year, falls well within the generally accepted threshold of £30,000."

In addition to cost-effectiveness, the new guidance emphasizes the clinical benefits of dual-chamber pacing.

For example, meta-analyses of various published studies considered by the committee showed a statistically significant reduction in atrial fibrillation, improvement in exercise capacity and improvement in quality of life, when dual-chamber pacing is compared to single-chamber pacing.

"NICE influences treatment decisions not just in the UK, but internationally as well," said Jenifer Ehreth, MD, a health economist with Medtronic (Minneapolis). "So we are especially pleased with this guidance on dual-chamber pacing. Because of these recommendations, people with bradycardia – starting with those in the UK – now stand a better chance of getting a dual-chamber pacemaker when that is the most appropriate choice for them."

Results of one of the randomized clinical trials considered by NICE for the new guidance appeared in the Jan. 18 issue of Circulation. The authors of the study, the Mode Selection in Sinus Node Dysfunction Trial (MOST), write: "For patients with sick sinus syndrome requiring pacing, dual-chamber pacing increases quality-adjusted life expectancy at a cost that is generally considered acceptable.

"Compared with [single-chamber] pacemakers, dual-chamber pacemakers in the MOST trial significantly reduced the rates of atrial fibrillation and hospitalization for heart failure and were associated with somewhat lower rates of stroke. This reduction in nonfatal events with dual-chamber pacemakers resulted in better quality of life observed during the trial on a number of measures and projected to an even greater extent beyond the trial because of the life expectancy of affected patients."

The NICE guidance is available online at www.nice.org.uk.