Cardiac Pacing in Severe Recurrent Reflex Syncope and Tilt-Induced Asystole

Autor: Michele Brignole, Alessio Gargaro, Jean Claude Deharo, Vincenzo Russo, Arnaud Aerts, Antonio Rapacciuolo, Alonso Pedrote, Serge Boveda, Marco Tomaino, Mario Orlando Oliveira, Francesco Arabia, BioSync Cls trial Investigators, Gerardo Nigro, Giampiero Maglia, Daniele Giacopelli
Přispěvatelé: Brignole, M., Russo, V., Arabia, F., Oliveira, M., Pedrote, A., Aerts, A., Rapacciuolo, A., Boveda, S., Deharo, J. C., Maglia, G., Nigro, G., Giacopelli, D., Gargaro, A., Tomaino, M., Clinical sciences, Brignole, Michele, Russo, Vincenzo, Arabia, Francesco, Oliveira, Mario, Pedrote, Alonso, Aerts, Arnaud, Rapacciuolo, Antonio, Boveda, Serge, Claude Deharo, Jean, Maglia, Giampiero, Nigro, Gerardo, Giacopelli, Daniele, Gargaro, Alessio, Tomaino, Marco, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
Jazyk: angličtina
Rok vydání: 2021
Předmět:
[SDV]Life Sciences [q-bio]
Syncope/etiology
030204 cardiovascular system & hematology
HSM CAR
stimulation
law.invention
Syncope / therapy
0302 clinical medicine
law
Tilt-Table Test
Clinical endpoint
030212 general & internal medicine
biology
Hazard ratio
Cardiac Pacing
Artificial
Syncope (genus)
Heart Arrest* / etiology
Pacemaker
Asystolic syncope
Treatment Outcome
Reflex syncope
Cardiac pacing
Closed loop
Syncope
Tilt testing
Cardiology
Cardiology and Cardiovascular Medicine
Adult
medicine.medical_specialty
03 medical and health sciences
Internal medicine
Reflex
medicine
Humans
Asystole
Adverse effect
Vasovagal syncope
Presyncope
business.industry
Syncope / etiology
Heart Arrest* / therapy
medicine.disease
biology.organism_classification
Heart Arrest
Heart Arrest/etiology
Artificial cardiac pacemaker
business
Zdroj: Repositório Científico de Acesso Aberto de Portugal
Repositório Científico de Acesso Aberto de Portugal (RCAAP)
instacron:RCAAP
European Heart Journal
European Heart Journal, 2021, 42 (5), pp.508-516. ⟨10.1093/eurheartj/ehaa936⟩
ISSN: 0195-668X
1522-9645
DOI: 10.1093/eurheartj/ehaa936⟩
Popis: Aim The benefit of cardiac pacing in patients with severe recurrent reflex syncope and asystole induced by tilt testing has not been established. The usefulness of tilt-table test to select candidates for cardiac pacing is controversial. Methods and results We randomly assigned patients aged 40 years or older who had at least two episodes of unpredictable severe reflex syncope during the last year and a tilt-induced syncope with an asystolic pause longer than 3 s, to receive either an active (pacing ON; 63 patients) or an inactive (pacing OFF; 64 patients) dual-chamber pacemaker with closed loop stimulation (CLS). The primary endpoint was the time to first recurrence of syncope. Patients and independent outcome assessors were blinded to the assigned treatment. After a median follow-up of 11.2 months, syncope occurred in significantly fewer patients in the pacing group than in the control group [10 (16%) vs. 34 (53%); hazard ratio, 0.23; P = 0.00005]. The estimated syncope recurrence rate at 1 year was 19% (pacing) and 53% (control) and at 2 years, 22% (pacing) and 68% (control). A combined endpoint of syncope or presyncope occurred in significantly fewer patients in the pacing group [23 (37%) vs. 40 (63%); hazard ratio, 0.44; P = 0.002]. Minor device-related adverse events were reported in five patients (4%). Conclusion In patients aged 40 years or older, affected by severe recurrent reflex syncope and tilt-induced asystole, dual-chamber pacemaker with CLS is highly effective in reducing the recurrences of syncope. Our findings support the inclusion of tilt testing as a useful method to select candidates for cardiac pacing. Study registration ClinicalTrials.gov identifier NCT02324920, Eudamed number CIV-05-013546.
Databáze: OpenAIRE
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