Βηματοδότηση στη νευροκαρδιογενή συγκοπή. Σκεύος Σιδερής Διευθυντής Καρδιολογικό Τμήμα Ιπποκράτειο Νοσοκομείο Αθηνών

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1 Βηματοδότηση στη νευροκαρδιογενή συγκοπή Σκεύος Σιδερής Διευθυντής Καρδιολογικό Τμήμα Ιπποκράτειο Νοσοκομείο Αθηνών

2 ΣΥΓΚΟΠΗ Ως συγκοπή ορίζεται η παροδική απώλεια της συνείδησης που οφείλεται σε παροδική γενικευμένη ατελή εγκεφαλική αιμάτωση και χαρακτηρίζεται από απότομη έναρξη, μικρή διάρκεια και αυτόματη πλήρη αποκατάσταση.

3 Vasovagal Syncope The neurally mediated syndromes are a collection of conditions in which neurocardiovascular reflexes designed to maintain cerebral perfusion are disorder in response to a trigger. This trigger results in vasodilation and/or concurrent bradycardia resulting in a fall in arterial blood pressure and subsequently cerebral perfusion pressure, resulting in syncope.

4 Eur Heart J 2009;30:

5 Vasovagal Syncope Vasovagal syncope (VVS) is the most common cause of syncope accounting for 20%-65% of cases in populationbased series. There is a bimodal distribution with peaks in teenage years and inthose over 65years. The clinical course is often self-limiting particularly in those <30 years and the prognosis is generally benign. N Engl J Med 2002;347: J Cardiovasc Electrophysiol 2008;19:48-55

6 Vasovagal Syncope The bradycardic or cardio-inhibitory component of neurally mediated syncope is the target for pacing therapy.

7 Vasovagal Syncope Vasovagal syncope is frequently a self-limiting condition. This has a considerable impact on decision making for invasive therapies, particularly in young people. In addition, there is a recognized morbidity attached to device implantation. N Engl J Med 2002;347: J Cardiovasc Electrophysiol 2008;19:48-55

Europace 2002;4:107-112 Am J Cardiol 2003;92:740-741 Pace

8 Europace 2002;4: Am J Cardiol 2003;92: Pace 2003:26: Europace 2010; 12: Heart Rhythm 2012;9:

9 Vasovagal Syncope-Pacing The first clinical trials examining pacing therapy in VVS were small non-randomized observation-all studies that reported a reduction in syncopal events but not symptoms. Likely due to the vasodepressor component unaffected by pacing. JACC 1999;33:16-20 Europace 2004;6:

10 Vasovagal Syncope-Pacing The first randomized trials arose around the time of the introduction of the rate-drop response algorithm. Some of the studies incorporated this algorithm whilst others did not. JACC 1999;33:16-20 Europace 2004;6:

11 VVS-Pacing versus standard therapy The VVS international study (VASIS) and the syncope diagnosis and treatment study (SYDIT). Both studies included patients with relatively frequent syncope. Both showed a significant reduction in syncope associated with pacing therapy. VASIS 5% vs 61% p= SYDIT 4.3% vs 25.5% p=0.004 Circulation 2000;104: Circulation 2001;6104:52-57

12 VVS-Pacing versus placebo Three have been undertaken. The second vasovagal pacemaker study (VPS II), the vasovagal syncope amd pacing trial (SYNPACE) and the third international study on syncope of unknown etiology (ISSUE 3). All three studies were international multi-center double blind randomized trials of dual chamber pacing with a ratedrop response algorithm (DDD-RDR) versus placebo pacing (ODO). JAMA 2003;289: Eur Heart J 2004;25: Circulation 2012;125:

13 VVS-VPS II The VPS II involved 100 patients with at least 6 episodes of syncope in total, or 3 or more in the preceding two years and a positive HUT but with no defined minimum heart rate during the test. 42% in the placebo group and 33% of the active treatment group had recurrent syncope p=0.14. JAMA 2003;289:

14 VVS-SYNPACE The SYNPACE involved 29 patients with the same total number of syncopal episodes as those in VPS II, but with the addition of at least one spontaneous syncopal episode following a positive HUT with an asystolic or mixed response on HUT. 38% of the placebo and 50% of the pacing group had recurrent syncope p=ns. Eur Heart J 2004;25:

15 SYNPACE Eur Heart J 2004;25:

16 DDD pacing versus closed-loop stimulation pacing The largest CLS trial involved 50 patients with at least 5 episodes of syncope with at least 2 in the preceding two years and a possitive cardio-inhibitory HUT randomized 2:1 to DDD-CLS or DDI back-up pacing. 0% of the DDD-CLS group had recurrent syncope in the first year versus 78% in the DDI group. Europace 2004;6:

17 Vasovagal Syncope-CLS Το Closed-loop Stimulation pacing (CLS) είναι ένα καινούργιο χαρακτηριστικό της Biotronik σε κάποιους βηματοδότες της και έχει να κάνει με τον τρόπο που λειτουργεί το Rate Response. Παρακολουθεί την ενδοκαρδιακή αντίσταση της δεξιάς κοιλίας και βάση αυτής βηματοδοτεί, προσομιάζοντας καλύτερα την βηματοδότηση με τον φυσιολογικό φλεβοκομβικό ρυθμό. Για τον λόγο αυτό το ονομάζουν και physiology rate-adaptive pacing.

18 VVS-ISSUE 3 The ISSUE 3 study, in which 511 patients over 40 years of age with at least three presumed neurally-mediated syncopal events over the preceding two years underwent ILR implantation. Eight nine patients had recurrent syncope with documented asystole on ILR and 77 underwent permanent pacing in a randomized, placebo controlled design to either DDD or ODO pacing. Circulation 2012;125:

19 VVS-ISSUE 3 Syncope recurrent in 57% of those in the placebo group and 25% of those paced p= % absolute and a 57%relative risk reduction in symptom recurrence with active pacing. The ISSUE 3 paper does not clarify the pattern of asystole, so it may be that pacing benefits were for intrinsic bradycardic problems rather than VVS. Circulation 2012;125:

20 ISSUE 3 Circulation 2012;125:

21 ISSUE 3 Circulation 2012;125:

22 ISSUE 3 Circulation 2012;125:

24 Conclusion Evidence suggest that only selected patients aged 40 years and older, with severe asystolic vasovagal syncope seem to benefit from permanent pacemakers, especially if symptoms are frequent and debilitating.

25 Σας Ευχαριστώ για την Προσοχή σας

26 Conclusion Pacing therapy in VVs should be reserved for older sufferers with relative frequent symptoms and spontaneous asystole documented during real-life monitoring. Pacing should be considered in those with unexlained syncope with reproduction of symptoms during a cardioinhibitory or mixed response to CSM, asystole more 3sec.

27 Vasovagal Syncope-Pacing Class IIa recommendation only in those over 40 years with frequent symptoms and a cardio-inhibitory response recorded during monitoring. Class IIb recommendation for refractory symptoms in the same age group in the presence of a documented cardioinhibitory response on HUT. Circulation 2008;117:

28 Carotid sinus syndrome Carotid sinus hypersensitivity (CSH) is defined as 3sec asystole (cardio-inhibitor type) or 50mmHg drop in systolic blood pressure (vasodepressor type) or both (mixed type) precipitated by carotid sinus massage (CSM). Eur Heart J 2009;30:

29 Carotid Sinus Syndrome

30 Carotid sinus syndrome We are left with non-randomized studies suggesting a clear benefit to pacing therapy in CSS and a small number of underpowered randomized trials suggesting a reduction in symptoms

31 Carotid sinus syndrome Pcing Evidence base has resulted in pacing therapy for CSS becoming a Class IIa recommendation in the ESC. Class I recommendation in the North American Equivalent. Eur Heart J 2009;30: Circulation 2008;117:

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