Marco Tomaino1, Cristina Romeo2, Elena Vitale3, Teresa Kus4, Angel Moya5, Nynke van Dijk6, Silvia Giuli7, Giorgia D'Ippolito8, Alessandra Gentili7, Richard Sutton9. 1. Department of Cardiology, Ospedale di Bolzano, Via Boelher, 5, 39100 Bolzano, Italy marco.tomaino@asbz.it. 2. Department of Cardiology, Ospedale di Bolzano, Via Boelher, 5, 39100 Bolzano, Italy. 3. Department of Cardiology, Ospedale SS. Antonio e Biagio e Cesare Arrigo, 15121 Alessandria, Italy. 4. Department of Cardiology, Hospital du Sacre-Coeur de Montreal, 5400 Montreal, Canada. 5. Department of Cardiology, Hospital Universitario Vall d'Hebron, 08035 Barcelona, Spain. 6. Department of Cardiology, Academisch Medisch Centrum, 1105 Amsterdam, The Netherlands. 7. EMEA Regional Clinical Center, Medtronic Clinical Research Institute, 00165 Rome, Italy. 8. Medtronic Italia, 00165 Rome, Italy. 9. Department of Cardiology, St. Mary's Hospital, Imperial College Healthcare NHS Trust, London W21NY, UK.
Abstract
AIMS: Physical counter-pressure manoeuvres (PCM) are effective in young patients with vasovagal syncope and recognizable prodromal symptoms. The aim of this study was to investigate their effectiveness in patients ≥40 years with severe neurally mediated syncope (NMS) enroled in the Third International Study on Syncope of Uncertain Etiology (ISSUE-3). METHODS AND RESULTS: In the ISSUE-3 study, 63 out of 162 patients had a diagnosis of hypotensive NMS (Types 2, 3, and 4A) documented by implantable loop recorder; of these, 40 were instructed to perform isometric leg and arm PCM therapy. Their mean age was 62 ± 13 years; 47% of patients had a history of some episodes without prodrome. A group of 45 untreated patients acted as controls. The primary endpoint was the time to first syncope recurrence. During follow-up, syncope recurred in 15 PCM patients (37%) and in 24 control patients (53%) (P = 0.14). At 21 months, the modelled syncope recurrence rates were 42% [95% confidence interval (CI): 27-61] and 64% (95% CI: 48-80), respectively (P = 0.27). CONCLUSION: In conclusion, many ISSUE-3 patients affected by hypotensive NMS have syncopal recurrence despite PCM. Older age and the absence of sufficiently long recognizable prodromal symptoms in the ISSUE-3 population might have hampered the effectiveness of PC therapy. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Physical counter-pressure manoeuvres (PCM) are effective in young patients with vasovagal syncope and recognizable prodromal symptoms. The aim of this study was to investigate their effectiveness in patients ≥40 years with severe neurally mediated syncope (NMS) enroled in the Third International Study on Syncope of Uncertain Etiology (ISSUE-3). METHODS AND RESULTS: In the ISSUE-3 study, 63 out of 162 patients had a diagnosis of hypotensive NMS (Types 2, 3, and 4A) documented by implantable loop recorder; of these, 40 were instructed to perform isometric leg and arm PCM therapy. Their mean age was 62 ± 13 years; 47% of patients had a history of some episodes without prodrome. A group of 45 untreated patients acted as controls. The primary endpoint was the time to first syncope recurrence. During follow-up, syncope recurred in 15 PCM patients (37%) and in 24 control patients (53%) (P = 0.14). At 21 months, the modelled syncope recurrence rates were 42% [95% confidence interval (CI): 27-61] and 64% (95% CI: 48-80), respectively (P = 0.27). CONCLUSION: In conclusion, many ISSUE-3 patients affected by hypotensive NMS have syncopal recurrence despite PCM. Older age and the absence of sufficiently long recognizable prodromal symptoms in the ISSUE-3 population might have hampered the effectiveness of PC therapy. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Renata Libanori Aleixo de Barros E Silva; Rubens Marcelo Volich; Pedro Gabriel Melo de Barros E Silva; Francisco Carlos da Costa Darrieux; Maurício Ibrahim Scanavacca; Denise Tessariol Hachul Journal: Sci Rep Date: 2022-04-06 Impact factor: 4.379