Standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncope: 3-year insights from the Syncope Unit Project 2 (SUP 2) study
Key result
Dual-chamber pacemaker implantation in patients with severe reflex syncope and an asystolic response resulted in a lower 3-year syncope recurrence rate compared to no pacemaker (20% vs 43%, P=0.01).
Why the study?
Does dual-chamber pacemaker implantation reduce syncope recurrence in patients aged >40 years with severe unpredictable recurrent reflex syncope and an asystolic response?
Population
281 patients aged >40 years, affected by severe unpredictable recurrent reflex syncope.
Comparison
Dual-chamber pacemaker implantation. vs Observation by means of an implantable loop…
Design
Cohort
Follow-up
mean 26 ± 11 months (up to 3 years)
Authors
Discussion
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Implication
Supports guideline-based pacing in reflex syncope long-term; hypothesis-generating, needs RCTs before practice change.
Key Points
- To assess the three-year clinical outcomes and determinants of success for cardiac pacing guided by a standardized diagnostic algorithm in older adults with severe reflex syncope.
- A multicenter interventional study (NCT01509534) evaluated 281 patients aged >40 years presenting with severe, unpredictable reflex syncope.
- Participants underwent sequential testing with carotid sinus massage (CSM), tilt testing (TT), and an implantable loop recorder (ILR); those demonstrating an asystolic response received a dual-chamber pacemaker.
- Enrolled patients were monitored over a mean follow-up duration of 26 ± 11 months to track syncope recurrence.
- Pacemakers were implanted in 137 patients, yielding an actuarial three-year syncope recurrence rate of 20% (95% CI 12–30), compared with 43% (95% CI 29–57) among 142 non-paced patients monitored by ILR (P = 0.01).
- Three-year recurrence rates did not differ significantly across groups with positive CSM (78 patients), positive TT (38 patients), or positive ILR (21 patients).
- Recurrence was significantly lower in patients with negative tilt tests at 5% (95% CI 0–15; n=20) compared with 24% (95% CI 10–38; n=61) in patients with positive tilt tests.
Study Design
Type
Observational (n=281)
Multicenter
Yes
Structured PICO
Does dual-chamber pacemaker implantation reduce syncope recurrence in patients aged >40 years with severe unpredictable recurrent reflex syncope and an asystolic response?
P
Population
281 patients aged >40 years with severe unpredictable recurrent reflex syncope, followed for a mean of 26 months.
E
Exposure
Dual-chamber pacemaker implantation (for patients with an asystolic response to carotid sinus massage, tilt testing, or implantable loop recorder).
C
Comparator
Observation by means of an implantable loop recorder (ILR) in patients who did not receive a pacemaker.
O
Outcome
Syncope recurrence rate at 3 years.
Main Result
Absolute Event Rate: 20% vs 43%
p-value: p=0.01
Dual-chamber pacing significantly reduces syncope recurrence at 3 years in older patients with severe unpredictable reflex syncope and an asystolic response to diagnostic testing.
Cite This Study
Brignole et al. (2015) conducted an observational in Severe unpredictable recurrent reflex syncope (n=281). Dual-chamber pacemaker vs. No pacemaker (observed by means of an implantable loop recorder) was evaluated on Actuarial syncope recurrence rate at 3 years (p=0.01). Dual-chamber pacemaker implantation in patients with severe reflex syncope and an asystolic response resulted in a lower 3-year syncope recurrence rate compared to no pacemaker (20% vs 43%, P=0.01).