LONG-TERM FOLLOW-UP OF DDDR CLOSED-LOOP PACING FOR RECURRENT VASO-VAGAL SYNCOPE
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1 LONG-TERM FOLLOW-UP OF DDDR CLOSED-LOOP PACING FOR RECURRENT VASO-VAGAL SYNCOPE M. Bortnik, G. Dell'era, E. Occhetta, L. Plebani, P. Marino University of Eastern Piedmont, Department of Cardiology, Novara, Italy Disclosure: none ESC, Stockholm, September 1 st 2010
2 Physiopathology of malignant VVS Visceral and/or periferic venous vasodilation: of RV filling and preload Sympathetic Tone, Heart Rate and Inotropic State of Myocardium Vigorous Contraction of insufficiently filled ventricle Stimulation of Ventricular Mechanoceptors Bezold - Jarish Reflex Afferent Vagal Signals Efferent Vagal Activity Efferent Sympathetic Discharge Hypotension + Bradycardia >>>>>> Vasovagal Syncope
3 Course of Contractility in VV spell Clinical studies have demonstrated that changes in myocardial contraction dynamics usually arise clearly before any drop of heart rate related to neurally mediated syncope Contractility course during a Vasovagal spell 100 a.u tilt up syncope supine -200 beat Recording of Intracardiac Impedance course during HUTT using an INOS 2 pacemaker programmed in DDD mode.
4 CLS Pacemakers (Biotronik): Blood volume-impedance Changes in intracardiac impedance are closely related to myocardium-blood ratio in the volume around the ventricular tip msec 128 Hz - An increase in blood volume produces a decrease in intracardiac impedance. - An enhanced contractility induces an increase of impedance around the electrode tip.
5 mmhg b.p.m. DDD-CLS pacing in VVS: RATIONALE At the onset of a VV spell Sympathetic Tone and Contractility increase. Contractility index [DDD pacing] Tilt-UP CLS Pacing will early react with a dominant pacing rate Syncope Tilt-DOWN Preventing the Sympathetic Tone and contrasting the Vagal Tone Hypotension and Bradycardia are prevented Syncope is PREVENTED HR and BP [HUTT in DDD-CLS] NO SYNCOPE minutes HR Syst Diast
6 Prevention of malignant vasovagal syncope with Closed Loop Stimulation the INVASY Italian Study E. Occhetta, M. Bortnik, R. Audoglio*, C. Vassanelli on behalf of INVASY Italian Study Group Div. of Cardiology, Faculty of Medicine, Università degli Studi del Piemonte Orientale, Novara, Italy; *SRA, Pavia, Italy EUROPACE 2004; 6:
7 INVASY Study - Patient Selection In the study were included patients with: 1) Neurally-mediated, malignant VVS; 2) > 5 VVS episodes reported, with > 2 episodes in the last year and > 1 episode in the last 6 months; 3) Head Up Tilt induced syncope (type 2A or 2B); 4) No other causes for syncope; 5) Age > 18 y
8 INVASY Study - STATISTICS Kaplan-Meier event-free curve for both arms Patients, n Pts with VVS recurrence, n (%) Total VVS episodes, n Mean VVS spells per pt, n Median time to 1st recurrence, months (range) Rate of VVS spells per year CLS arm 41 0 (0) PLACEBO arm 9 7 (78) ±0.8 4 (0.5-11) 1.52
9 BACKGROUND The single-blinded, randomized, controlled INVASY study demonstrated the usefulness of CLS in recurrent VVS. Nevertheless, a long-term follow-up of patients with DDDR-CLS pace-maker was not available. The aim of our study was to evaluate long-term vaso-vagal syncope recurrence in our selected CLS patients population.
10 STUDY POPULATION 39 patients implanted with DDDR-CLS since April 1998 for VASIS 2A-2B VVS with a f.u. > 1 year 20 males Mean age 61 ± 15 years (range 22-80) Concomitant heart disease: - 25 none - 7 hypertensive - 6 CAD - 1 valvular (previous aortic replacement) No patients had LV dysfunction Pre-implant -blocker therapy: 6 patients 2 patients already implanted with conventional DDDR PM
11 RESULTS I 1 patient: lost at f.u. 4: died. 34 (87%) patients: available data Mean follow-up: 60 ± 35 months (total 1986 months) Mean pre-implant VVS/pt: 6.1 ± 6.3 (range 1-24)
12 RESULTS II 29/34 (85%) patients: no VVS recurrence 5/34 (15%) patients: VVS recurrence mean post-implant VVS/pt: 3.0 ± 2.5 (range 1-7) The number of post-implant syncopal spells was never greater than the pre-implant one
13 Pre/post PM syncopes for each patient
14 RESULTS III Pre-implant: 212 syncopal spells (mean number 6/pt, range 1-24) Post- implant: 5 pts with syncopal recurrences (syncope burden always declined; 15 total episodes, range 1-7/pt): -1 pt: CLS switched off for palpitations with recurrence of 4 syncopal episodes in the following 8 months -1 pt: syncopal recurrence at ERI (VVI auto switch)
15 RESULTS IV Kaplan-Meier event-free curve
16 J Interv Card Electrophysiol 2010; 27:69-73
17 CONCLUSIONS For selected patients with indication to cardiac pacing for malignant VVS contractility-related DDDR pacing is probably the best pacing mode as it appears to offer even in still symptomatic patients a great degree of symptomatic relief. The results of our study seem to confirm that DDDR-CLS is an extremely useful tool in preventing recurring VVS even during a long-term follow-up confirming the previous results of the short-term evaluation in the INVASY prospective study.
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