LIMITED UTILITY OF PHYSICAL COUNTER-PRESSURE MANEUVRES IN PREVENTING SYNCOPAL RECURRENCE IN PATIENTS OLDER THAN 40 YEARS WITH RECURRENT NEURALLY-MEDIATED SYNCOPE. AN ANALYSIS FROM THE THIRD INTERNATIONAL STUDY ON SYNCOPE OF UNCERTAIN ETIOLOGY (ISSUE-3)
C. Romeo (1), E. Vitale (2), T. Kus (3), A. Moya (4), W. Wieling (5), S. Giuli (6), A. Gentili (6), R. Sutton (7) on behalf of the International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators
1. Ospedale di Bolzano, Bolzano, Italy (MT,CR) 2. Ospedale SS.Antonio e Biagio e Cesare Arrigo, Alessandria, Italy (EV) 3. Hospital du Sacre-Coeur de Montreal, Canada (TK) 4. Hospital Universitario Vall d´Hebron, Barcelona, Spain (AM) 5. Academisch Medisch Centrum, Amsterdam (WW) 6. Medtronic Italia, Italy (SG,AG) 7. St.Mary´s Hospital, Imperial College Healthcare NHS Trust, London, UK (RS)
Aims: Physical counter-pressure maneuvers are effective in young patients with vasovagal syncope and recognizable prodromal symptoms. Aim of this study was to investigate their effectiveness in patients ?40 years with severe neurally mediated syncope (NMS) enrolled 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 (type 2,3 and 4A) documented by implantable loop recorder (ILR); of these, 40 were instructed to perform isometric leg and arm physical counter-pressure maneuver (PCM) therapy. Their mean age was 62±13 years; 71% of patients had a history of some episodes without prodrome. A group of 45 untreated patients acted as controls. During follow-up, syncope recurred in 15 PC patients (39%) and in 24 control patients (53%). At 21 months, the estimated product-limit syncope recurrence rates were 42% (95%CI 29-62) and 64% (95%CI 48-80) respectively (p=0.30).
Conclusions: The benefit of PC maneuvers was limited in ISSUE-3 patients affected by hypotensive NMS. The likely factors that hampered effectiveness of PC therapy were older age and absence of sufficiently long recognizable prodromal symptoms in the ISSUE-3 population.
