The study included 54 patients aged 40 or older were recruited from 11 medical centres in Spain and Canada
A Spain study published in the Journal of the American College of Cardiology has shown the results for the first prospective double-blind placebo-controlled trial. BIOTRONIK’s rate responsive technology, Closed Loop Stimulation (CLS) has shown to reduce fainting in pacemaker patients with vasovagal syncope up to sevenfold. Results from the “The remarkable benefits of BIOTRONIK CLS pacemakers for patients suffering from dangerous recurrent syncope are gaining recognition among physicians, but this is the first time that this technology has been proven by a clinical trial,” said the study’s primary investigator, Dr Gonzalo Baron-Esquivias, Hospital Virgen del Rocio, Seville, Spain. “If the findings are confirmed by larger studies, like the ongoing BioSync CLS trial, it could spell a change in international guidelines to recommend CLS pacing in this patient group.”
In the SPAIN study, 54 patients aged 40 or older were recruited from 11 medical centres in Spain and Canada. All had experienced more than five episodes of syncope in their lifetimes and furthermore had more than two episodes in the previous year. Half were randomly assigned to receive DDD-CLS pacing for 12 months and the other half control pseudo-DDI pacing. After 12 months, patients were crossed over to the other pacing programme. If a patient in either group had more than three episodes of syncope in one month, their pacing assignment was switched.
The primary endpoint of a greater than 50 per cent reduction of syncopal episodes compared with the previous year was met. During the trial, four patients experienced syncope while receiving CLS pacing, compared with 21 patients who fainted during pseudo DDI pacing. Among patients initially assigned CLS, 72.2 per cent had a reduction of more than 50 per cent in syncope episodes within the first year. However syncope recurred after they crossed over to the DDI group. Patients who crossed over to DDD-CLS after a year of placebo pacing saw a reduction of more than 50 per cent in syncopal episodes during the second year.