Dual-Chamber Pacing in the Treatment of Neurally Mediated Tilt-Positive Cardioinhibitory Syncope: Pacemaker Versus No Therapy: A Multicenter Randomized Study
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Background —This study was performed to compare implantation of a DDI pacemaker with rate hysteresis with no implant in respect to syncopal recurrences in patients with severe cardioinhibitory tilt-positive neurally mediated syncope. Methods and Results —Forty-two patients from 18 European centers were randomized to receive a DDI pacemaker programmed to 80 bpm with hysteresis of 45 bpm (19 patients) or no pacemaker (23 patients). Inclusion criteria were ≥3 syncopes over the last 2 years and a positive cardioinhibitory (Vasovagal Syncope International Study types 2A and 2B) response to tilt testing. The median number of previous syncopal episodes was 6; asystolic response to tilt testing was present in 36 patients (86%) (mean asystole, 13.9±10.2 seconds). All patients were followed up for a minimum of 1.0 years and a maximum of 6.7 years (mean, 3.7±2.2). One patient (5%) in the pacemaker arm experienced recurrence of syncope compared with 14 patients (61%) in the no-pacemaker arm ( P =0.0006). In the no-pacemaker arm, the median time to first syncopal recurrence was 5 months, with a rate of 0.44 per year. On repeated tilt testing performed within 15 days after enrollment, positive responses were observed in 59% of patients with pacemakers and in 61% of patients without pacemakers ( P =NS). Conclusions —In a limited, select group of patients with tilt-positive cardioinhibitory syncope, DDI pacing with hysteresis reduced the likelihood of syncope. The benefit of the therapy was maintained over the long term. Even in untreated patients, the syncopal recurrence burden was low. A negative result of tilt testing was not a useful means to evaluate therapy efficacy.
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Earlier observational, open-label, and single-blind pacing studies were uniformly positive, but two subsequent double-blind studies in adults were negative.
“Although earlier observational, open-label, and single-blind studies have been uniformly positive, the results of 2 subsequent double-blind studies in adults were negative.133–138”
From 2015 Heart Rhythm Society Expert Consensus Statement on the Diagnosis and Treatment of Postural Tachycardia Syndrome, Inappropriate Sinus Tachycardia, and Vasovagal Syncope (2015) · cites this paper as [134]
The Comparison With the North American Vasovagal Pacemaker Study section says this study and an earlier randomized study found favorable results, and that neither was blinded. The Study Limitations section also confirms that this trial was unblinded. Our copy does not establish that observational and single-blind studies were uniformly positive or report the two subsequent negative double-blind studies. Page numbers were not available in the indexed passages. (LLM, conf=0.88)
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- Authors
- Sutton, R., Brignole, M., Menozzi, C., Raviele, A., Alboni, P., Giani, P., & Moya, A.
- Affiliations
- Royal Brompton Hospital (GB)
- From the Departments of Cardiology of Royal Brompton Hospital, London, UK (R.S.); Ospedali Riuniti, Lavagna, Italy (M.B.); Ospedale S Maria Nuova, Reggio Emilia, Italy (C.M.); Ospedale Umberto I, Mestre, Italy (A.R.); Ospedale Civile, Cento, Italy (P.A.); Ospedale Bolognini, Seriate, Italy (P.G.); and Hospital Vall d’Hebron, Barcelona, Spain (A.M.).
- Venue
- Circulation
- Published
- 2000-07-18
- Volume
- 102
- Issue
- 3
- Pages
- 294-299
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2146164209
- Semantic Scholar
- c28164248f1c501df5bec6c2ee6573fd498c9ef9
- Cited by
- 407
- References
- 22
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 3 · 2023: 6 · 2022: 5 · 2021: 14 · 2020: 10 · 2019: 12 · 2018: 11 · 2017: 23 · 2016: 8 · 2015: 12 · 2014: 17 · 2013: 17 · 2012: 16
- FWCI
- 25.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Funders
- St. Jude Medical
- Topics
- Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
- Keywords
- DDD pacing, cardioinhibitory syncope, neurally mediated syncope, vasovagal syncope, syncope recurrence, implantable cardioverter-defibrillator, asystole, tilt table test, pacemaker therapy
- MeSH terms
- Aged, Cardiac Pacing, Artificial, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Treatment Outcome, Tilt-Table Test, Syncope, Vasovagal, Secondary Prevention
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