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Study data presented at the American College of Cardiology's annual scientific session suggest that patients with recurrent syncope who received a pacemaker delivering a pacing programme, with Biotronic's closed loop stimulation (DDD-CLS), designed to detect and stop the abnormal heart rhythms that precede syncope had a seven-fold reduction in fainting compared with placebo, ScienceDaily reported Monday.
The SPAIN trial included 54 patients, aged 40 or older, who had experienced more than five episodes of syncope in their lifetimes, with more than two in the past year.
The participants were implanted with a pacemaker and half were randomly assigned to receive DDD-CLS pacing for 12 months and the other half were assigned to the placebo group, receiving a pacing programme called DDI, which does not respond to the contractions in the heart that precede syncope.
After 12 months, the two programmes were switched, and if a patient in either group had more than three episodes of syncope in one month, their pacing assignment was switched.
Overall, 46 patients completed the two-year trial, during which time four patients experienced syncope while receiving DDD-CLS pacing, compared with 21 patients who fainted during DDI pacing.
Of the patients initially assigned to DDD-CLS, 72.2 percent had a reduction of more than 50 percent in syncope episodes within the first year, but fainting recurred when they crossed over to the DDI group, while patients who crossed over to DDD-CLS after a year of placebo had a reduction of more than 50 percent in syncope episodes during the second year.
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