NEW YORK (Reuters Health) – The placement of a permanent pacemaker for dual-chamber pacing had no effect on the frequency of falls among older patients with a history of falls and cardioinhibitory carotid sinus hypersensitivity in a small, randomized, double-blind, placebo-controlled trial.

The study investigators, led by Dr. S. W. Parry at Royal Victoria Infirmary, Newcastle upon Tyne, UK, and co-investigators, enrolled 34 consecutive subjects age 55 years or older (median age 77.5 years) with carotid sinus hypersensitivity as the sole attributable cause of at least three unexplained falls in the previous 6 months. All subjects underwent dual-chamber permanent pacemaker implantation with rate-drop response programming.

Following a 1-month run-in period in which pacemakers were turned on, patients were randomized to either continue in the on mode or for the pacing to be turned off. After 6 months, patients crossed over to the opposite group for 6 more months. During the trial, the subjects completed daily fall diaries. Twenty-five patients completed the study.

The results showed no significant difference in the number of falls during the two treatment periods, with a mean of 3.48 falls per patient during the period in off mode versus 4.04 falls during the period with the pacemaker turned on. The authors also detected no significant differences between study periods in the time to first fall.

Writing in the March issue of Heart, the authors note that a high attrition rate left the study under-powered. Still, they maintain: “This work is important in showing that a placebo-controlled pacing study is feasible and well tolerated in this population, and further work is needed to establish the continued relevance of permanent pacing in unexplained fallers with carotid sinus hypersensitivity.”

Commenting in a related editorial, Dr. Cengiz Ermis at Akdeniz University Medical School in Antalya, Turkey, and Dr. David G. Benditt at the University of Minnesota Medical School, Minneapolis, note that the clinical problem addressed by Dr. Parry’s group “remains an important one,” and the insight they provide “will certainly prove valuable.”

The editorialists still believe that treatable cardiac arrhythmias play an important role in non-accidental falls.

“Consequently,” they conclude, “the next step may be development of a trial utilizing next-generation wearable or implantable loop recorders as a means of better assessing propensity to intermittent arrhythmias in recurrent fallers.”

Reference:
Heart 2009;95:350-352,405-409.