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Benefit of pacemaker therapy in patients with presumed neurally mediated syncope and documented asystole is greater when tilt test is negative: an analysis from the third International Study on Syncope of Uncertain Etiology (ISSUE-3)
- Source :
- Circulation. Arrhythmia and electrophysiology. 7(1)
- Publication Year :
- 2013
-
Abstract
- Background— In the Third International Study on Syncope of Uncertain Etiology (ISSUE-3), cardiac pacing was effective in reducing recurrence of syncope in patients with presumed neurally mediated syncope (NMS) and documented asystole but syncope still recurred in 25% of them at 2 years. We have investigated the role of tilt testing (TT) in predicting recurrences. Methods and Results— In 136 patients enrolled in the ISSUE-3, TT was positive in 76 and negative in 60. An asystolic response predicted a similar asystolic form during implantable loop recorder monitoring, with a positive predictive value of 86%. The corresponding values were 48% in patients with non–asystolic TT and 58% in patients with negative TT ( P =0.001 versus asystolic TT). Fifty-two patients (26 TT+ and 26 TT–) with asystolic neurally mediated syncope received a pacemaker. Syncope recurred in 8 TT+ and in 1 TT– patients. At 21 months, the estimated product-limit syncope recurrence rates were 55% and 5%, respectively ( P =0.004). The TT+ recurrence rate was similar to that seen in 45 untreated patients (control group), which was 64% ( P =0.75). The recurrence rate was similar between 14 patients with asystolic and 12 with non–asystolic responses during TT ( P =0.53). Conclusions— Cardiac pacing was effective in neurally mediated syncope patients with documented asystolic episodes in whom TT was negative; conversely, there was insufficient evidence of efficacy from this data set in patients with a positive TT even when spontaneous asystole was documented. Present observations are unexpected and need to be confirmed by other studies. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01463358.
- Subjects :
- Male
medicine.medical_specialty
Time Factors
Neurally-mediated syncope
Tilt table test
Double-Blind Method
Heart Rate
Predictive Value of Tests
Recurrence
Tilt-Table Test
Physiology (medical)
Internal medicine
medicine
Implantable loop recorder
Syncope, Vasovagal
Humans
In patient
Asystole
Aged
biology
medicine.diagnostic_test
business.industry
Syncope (genus)
Cardiac Pacing, Artificial
Middle Aged
biology.organism_classification
medicine.disease
Surgery
Heart Arrest
Clinical trial
Europe
Treatment Outcome
Cardiology
Etiology
Female
Cardiology and Cardiovascular Medicine
business
Subjects
Details
- ISSN :
- 19413084
- Volume :
- 7
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Circulation. Arrhythmia and electrophysiology
- Accession number :
- edsair.doi.dedup.....9fed51b33c5535912323ce583162a4a0