BIOSync CLS

Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole

Paciente / Población Intervención / Exposición Comparación Desenlace

In 127 patients aged 40 years or older with severe recurrent reflex syncope and tilt-induced asystole, a dual-chamber pacemaker with closed-loop stimulation reduced recurrence of syncope compared with the same pacemaker programmed off.

127

Diseño

Double-blind RCT (pacing on vs off)

Desenlace

Time to first recurrence of syncope

Relevancia

ResultadoSyncope in 16 % vs 53 % over a median 11.2 months (HR 0.23; 95 % CI 0.11–0.47; p=0.00005). Estimated 2-year recurrence 22 % vs 68 %.

Brignole M, Russo V, Arabia F, et al. Eur Heart J. 2021;42(5):508-516. 10.1093/eurheartj/ehaa936

Discusión y crítica

Small, industry-sponsored, and with no conventional dual-chamber comparator it cannot isolate the contribution of closed-loop stimulation. Its importance is that it validates the tilt table — not only the loop recorder — as a way to select pacing candidates, with a larger effect than ISSUE-3.