Pacemaker therapy in patients with neurally mediated syncope and documented asystole: Third International Study on Syncope of Uncertain Etiology (ISSUE-3): a randomized trial.
Details
Serval ID
serval:BIB_C7A95A0C4F43
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Pacemaker therapy in patients with neurally mediated syncope and documented asystole: Third International Study on Syncope of Uncertain Etiology (ISSUE-3): a randomized trial.
Journal
Circulation
Working group(s)
International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators
Contributor(s)
Tomaino M., Pescoller F., Donateo P., Oddone D., Russo V., Pierri F., Matino MG., Vitale E., Massa R., Piccinni G., Melissano D., Menozzi C., Lolli G., Gulizia M., Francese M., Iorfida M., Golzio P., Gaggioli G., Laffi M., Rabjoli F., Cecchinato C., Ungar A., Rafanelli M., Chisciotti V., Morrione A., Del Rosso A., Guernaccia V., Palella M., D'Agostino C., Campana A., Brigante M., Miracapillo G., Addonisio L., Proclemer A., Facchin D., Vado A., Menardi A., Vincenti A., De Ceglia S., Bartoletti A., Rossi D., Paulmichl R., Giammaria M., Orlando F., Botto G., Russo G., Beiras Torrado X., Campo EG., Moya£££Á£££ Á. , Roca I., Rivas N., Perez J., Senador G., Alonso C., Fácila Rubio L., Perez Alcalá F., Montagud Balaguer V., Peset A., Mut T., Toquero Ramos J., Lozano IF., Castro V., García Sacristán JF. , Ceres R., Enero J., Atienza F., Arenal£££Á£££ Á. , Gonzalez Torrecilla E., Chueca E., Mercader J., Garcia Civera R., Ruiz Granell R., Morell Cabedo S., Ebert HH., Stenzel G., Andresen D., Wedegärtner G., Atmowihardjo I., Bach U., Ohler J., Spencker S., Schirdewahn A., Kääb S., Sinner MF., Topp H., Sutton R., Francis D., Kamalvand K., Asgari M., Kus T., Strurmer M., Krahn A., Yee R., Klein GJ., Sheldon R., Sumner G., Smylie P., Polasek C., Morillo C., Healey J., Connolly S., Aerst AJ., Wieling W., Knops RE., Dekker LR., van der Voort PH. , Ruiter JH., Romme JJ., Deharo JC., Peyrouse E., Blanc JJ., Fatemi M., Pruvot E., Graf D., Grander W., Eller P.
ISSN
0009-7322
ISSN-L
1524-4539 (Electronic)
Publication state
Published
Issued date
2012
Peer-reviewed
Oui
Volume
125
Number
21
Pages
2566-2571
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't Publication Status: ppublish. Le CHUV (E. Pruvot et D. Graf) a participé à l'étude "ISSUE‐3 (Third International Study on Syncope of Uncertain Etiology)".
Abstract
BACKGROUND: The efficacy of cardiac pacing for prevention of syncopal recurrences in patients with neurally mediated syncope is controversial. We wanted to determine whether pacing therapy reduces syncopal recurrences in patients with severe asystolic neurally mediated syncope.
METHODS AND RESULTS: Double-blind, randomized placebo-controlled study conducted in 29 centers in the Third International Study on Syncope of Uncertain Etiology (ISSUE-3) trial. Patients were ≥40 years, had experienced ≥3 syncopal episodes in the previous 2 years. Initially, 511 patients, received an implantable loop recorder; 89 of these had documentation of syncope with ≥3 s asystole or ≥6 s asystole without syncope within 12 ± 10 months and met criteria for pacemaker implantation; 77 of 89 patients were randomly assigned to dual-chamber pacing with rate drop response or to sensing only. The data were analyzed on intention-to-treat principle. There was syncope recurrence during follow-up in 27 patients, 19 of whom had been assigned to pacemaker OFF and 8 to pacemaker ON. The 2-year estimated syncope recurrence rate was 57% (95% CI, 40-74) with pacemaker OFF and 25% (95% CI, 13-45) with pacemaker ON (log rank: P=0.039 at the threshold of statistical significance of 0.04). The risk of recurrence was reduced by 57% (95% CI, 4-81). Five patients had procedural complications: lead dislodgment in 4 requiring correction and subclavian vein thrombosis in 1 patient.
CONCLUSIONS: Dual-chamber permanent pacing is effective in reducing recurrence of syncope in patients ≥40 years with severe asystolic neurally mediated syncope. The observed 32% absolute and 57% relative reduction in syncope recurrence support this invasive treatment for the relatively benign neurally mediated syncope.
CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359203.
METHODS AND RESULTS: Double-blind, randomized placebo-controlled study conducted in 29 centers in the Third International Study on Syncope of Uncertain Etiology (ISSUE-3) trial. Patients were ≥40 years, had experienced ≥3 syncopal episodes in the previous 2 years. Initially, 511 patients, received an implantable loop recorder; 89 of these had documentation of syncope with ≥3 s asystole or ≥6 s asystole without syncope within 12 ± 10 months and met criteria for pacemaker implantation; 77 of 89 patients were randomly assigned to dual-chamber pacing with rate drop response or to sensing only. The data were analyzed on intention-to-treat principle. There was syncope recurrence during follow-up in 27 patients, 19 of whom had been assigned to pacemaker OFF and 8 to pacemaker ON. The 2-year estimated syncope recurrence rate was 57% (95% CI, 40-74) with pacemaker OFF and 25% (95% CI, 13-45) with pacemaker ON (log rank: P=0.039 at the threshold of statistical significance of 0.04). The risk of recurrence was reduced by 57% (95% CI, 4-81). Five patients had procedural complications: lead dislodgment in 4 requiring correction and subclavian vein thrombosis in 1 patient.
CONCLUSIONS: Dual-chamber permanent pacing is effective in reducing recurrence of syncope in patients ≥40 years with severe asystolic neurally mediated syncope. The observed 32% absolute and 57% relative reduction in syncope recurrence support this invasive treatment for the relatively benign neurally mediated syncope.
CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359203.
Keywords
Aged, Double-Blind Method, Female, Follow-Up Studies, Heart Arrest/complications, Humans, Incidence, Male, Middle Aged, Pacemaker, Artificial, Recurrence/prevention & control, Severity of Illness Index, Syncope/epidemiology, Syncope/etiology, Treatment Outcome
Pubmed
Web of science
Open Access
Yes
Create date
18/01/2013 17:50
Last modification date
20/08/2019 16:42
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