Safety and efficacy of leadless pacemaker for cardioinhibitory vasovagal syncope.
Heart Rhythm
; 17(9): 1575-1581, 2020 09.
Article
in En
| MEDLINE
| ID: mdl-32389681
ABSTRACT
BACKGROUND:
Single-chamber leadless pacemakers (LPs) have been shown to be an effective alternative to conventional transvenous pacemakers (CTPs), but their benefit in the context of cardioinhibitory vasovagal syncope (CI-VVS) is unknown.OBJECTIVE:
The purpose of this study was to evaluate the safety and efficacy of LP compared with dual-chamber CTP for CI-VVS.METHODS:
We conducted a multicenter, retrospective study comparing patients who received LP or dual-chamber CTP for drug-refractory CI-VVS. CI-VVS was diagnosed clinically and supported by cardiac monitoring and head-up tilt table testing. The primary efficacy endpoint was freedom from syncope during follow-up. Secondary endpoints included device efficacy and safety estimated by device-related major and minor adverse events (AEs).RESULTS:
Seventy-two patients (24 LP, 48 CTP; age 32 ± 5.5 years; 90% female; syncope frequency 7.6 ± 3.4 per year) were included. At 1 year, 91% of patients (22/24) in the LP group and 94% of patients (43/48) in the CTP group met the primary efficacy endpoint (P = .7). Device efficacy endpoint was met in 92% of the LP group and 98% of the CTP group (P = .2). Early major AEs occurred in 2 of 24 in the LP group and 3 of 48 in the CTP group (P = .4). Late major AEs occurred in 0 of 24 in the LP group and 2 of 48 in the CTP group (P = 1).CONCLUSION:
In patients with CI-VVS, single-chamber LP demonstrated equivalent efficacy in reducing syncopal events compared to dual-chamber CTP, with a similar safety profile.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pacemaker, Artificial
/
Cardiac Pacing, Artificial
/
Syncope, Vasovagal
Type of study:
Diagnostic_studies
/
Observational_studies
/
Prognostic_studies
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
En
Journal:
Heart Rhythm
Year:
2020
Document type:
Article