Why the study?
Many vasovagal syncope patients experience recurrences despite standard recommendations, and uncertainties remain regarding pacing efficacy when using head-up tilt testing to select patients.
Does dual-chamber pacing with closed-loop system (DDD-CLS) reduce syncopal recurrence in patients with cardioinhibitory vasovagal syncope?
Does dual-chamber pacing with closed-loop system (DDD-CLS) reduce syncopal recurrence in patients with cardioinhibitory vasovagal syncope?
In patients with highly symptomatic cardioinhibitory vasovagal syncope, pacing with a closed-loop system significantly reduces syncope recurrence and improves quality of life.
May reduce syncope burden in ILR-positive cardioinhibitory VVS; leaves open need for larger RCTs before practice change.
One in three vasovagal syncope (VVS) patients has syncopal recurrence after diagnosis, despite the standard recommendations for the avoidance of a recurrence, and one in five patients has more than one syncopal recurrence in the medium term. Given the high prevalence of VVS, there is a large population that continues to need effective treatment. There are numerous studies that use the implantable loop recorder (ILR) to document a cardioinhibitory response during VVS, with one study, ISSUE-3, demonstrating the efficacy of pacing using the rate-drop-response algorithm to trigger pacing and prevent syncopal recurrence in this population. There are more uncertainties in the studies that have used head-up tilt test (HUT) to select the population for pacing. We have recently performed the SPAIN randomized, controlled clinical trial using HUT to select the patients for pacing. The conclusion of the study was that, with the closed-loop system to introduce pacing, there was a significant reduction in the burden of syncope and a seven-fold increase in the time to first recurrence of syncope, which was greater than in the ISSUE-3 study. Since the completion of the SPAIN trial and its inclusion in the European guidelines, in our daily clinical practice, the use of this therapy is still recommended with caution in the context of the available literature, but it has increased our confidence in so doing. One in five patients with VVS needs treatment because of a high syncopal load. If an ILR is used to select the patients for pacing, the rate-drop-response algorithm can be recommended. In patients who have asystole on HUT, pacing with the closed-loop system has higher success and must now be considered as a tenable option for VVS patients.
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Barón‐Esquivias et al. (2020) studied this question.
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