© 2003 by European Society of Cardiology
The DDDR closed loop stimulation for the prevention of vasovagal syncope: results from the INVASY prospective feasibility registry
Divisione Clinicizzata di Cardiologia, Facolta' di Medicina e Chirurgia di Novara, Universita' degli Studi del Piemonte Orientale Novara, Italy
BACKGROUND: The contraction dynamics of the ventricular myocardium are affected before and during vasovagal fainting suggesting that the Closed Loop Stimulation (CLS) pacemaker could be useful for the treatment of these patients. CLS is a new concept of heart rate modulation in cardiac pacing. The pacemaker INOS2 CLS (Biotronik, Germany) derives its information for heart rate optimization from myocardial contraction dynamics, by measuring right ventricular intracardiac impedance. The pacemaker becomes an integral part of the circulatory regulation and, therefore, reacts appropriately to different cardiovascular demands.
METHODS: In a prospective registry, 34 patients with a history of recurrent vasovagal syncopal events were implanted with INOS2 DDDR CLS pacemakers. The aim of the study was to evaluate both long term clinical outcome, including the first recurrence of syncope, with DDDR-CLS pacing and acute precipitation of vasovagal fainting with DDDR-CLS mode compared with DDD during head up tilt testing.
RESULTS: During a follow up period of 1250 months, 30 patients experienced no further syncopal events in daily life; 1 patient had no syncope but night palpitations, which were eliminated by pacemaker reprogramming; 2 patients had presyncopal episodes but not syncopes; 3 syncopal recurrences occurred in one patient in chronic atrial fibrillation, possibly not an ideal candidate for implantation.
CONCLUSIONS: Further studies for detailed understanding of the preventive mechanism of DDDR-CLS pacing in vasovagal syncope are warranted. A randomized multicentre prospective new study (INotropy controlled pacing in VAsovagal SYncope: INVASY) is now in progress to confirm the beneficial effect of DDDR-CLS pacing in a larger group of patients with recurrent vasovagal syncope.
Key Words: Closed loop stimulation, pacemaker, vasovagal syncope, head up tilt test
Correspondence: Dr Occhetta Eraldo, Divisione Clinicizzata di Cardiologia, Azienda Ospedaliera Maggiore della Carita', Corso Mazzini 18, 28100 Novara, Italy. Tel.: +39 0321 3733413; Fax: +39 0321 3733407; E-mail: cardio1{at}maggioreosp.novara.it, occhetta{at}r-j.it
[1] Schaldach M and Hutten H. Intracardiac impedance to determine sympathetic activity in rate responsive pacing. Pacing Clin Electrophysiol 1992; 15: 17781786.[CrossRef][Medline]
[2] Pichlmaier AM, Braile D, Ebner E, et al. Autonomic nervous system controlled closed loop cardiac pacing. Pacing Clin Electrophysiol 1992; 15: 17871791.[CrossRef][Medline]
[3] Osswald S. Correlation of intracardiac impedance and right ventricular contractility during dobutamin stress test. In Raviele A (Ed.). Cardiac Arrhythmias 1997; Venice Fifth international workshop pp. 89.
[4] Witte J, Pichlmaier AM, Ebner E, et al. ANS controlled rate adaptive pacing. A clinical evaluation. Eur J Card Pacing Electrophysiol 1996; 6: 5359.
[5] Fitzpatrick A, Theodorakis R, Ahmed R, Williams T, Sutton R. Dual chamber pacing aborts vasovagal syncope induced by head-up 60° tilt. Pacing Clin Electrophysiol 1991; 14: 1319.[CrossRef][Medline]
[6] Petersen MEV and Sutton R. Cardiac pacing for vasovagal syncope: a reasonable therapeutic option? Pacing Clin Electrophysiol 1997; 20: 824826.[CrossRef][Medline]
[7] Benditt DG, Sutton R, Gammge MD, et al. Clinical experience with Thera DR rate-drop response pacing algorithm in carotid sinus syndrome and vasovagal syncope. Pacing Clin Electrophysiol 1997; 20: 832839.[CrossRef][Medline]
[8] Deharo JC, Peyre JP, Ritter PH, Chalvidan T, Berland Y, Djiane P. A sensor-based evaluation of heart contractility in patients with head- up tilt-induced syncope. Pacing Clin Electrophysiol 1998; 21: 223226.[CrossRef][Medline]
[9] Brignole M, Menozzi C, Corbucci G, Garberoglio B, Plicchi G. Detecting incipient vasovagal syncope: intraventricular acceleration. Pacing Clin Electrophysiol 1997; 20: 801805.[CrossRef][Medline]
[10] Liu JE, Hahn RT, Stein KM, et al. Left ventricular geometry and function preceding neurally mediated syncope. Circulation 2000; 101: 777783.
[11] Occhetta E, Bortnik M, Paffoni P, et al. Neurohumoral effects on closed loop stimulation. In Santini M (Ed.). VIII International Symposium Progress in Clinical Pacing 1998; Rome Free Papers Textbook pp. 3943.
[12] Zecchi P, Bellocci F, Sanna T, et al. Clinical benefit of closed loop stimulation. Preliminary results of an intensive validation study. Progress in Biomedical Research 1999; 4: 185189.
[13] Ravazzi AP, Diotallevi P, Zecchi P. Influence of rate modulation on hemodynamics. In Adornato E (Ed.). Cardiac Arrhythmias: How to Improve the Reality in the Third Millenium 2000; Rome Edizioni Luigi Pozzi pp. 511520.
[14] Fitzpatrick A, Theodorakis G, Travill C, et al. Incidence of malignant vasovagal syndrome in patients with recurrent syncope. Eur Heart J 1991; 12: 389394.
[15] Weissler AM and Warren JV. Syncope: pathophysiology and differential diagnosis. In Hurst JW, Louge RB, Rackley CE (Eds.), et al. The Heart 1986; New York McGraw Hill 507529.
[16] Van Lieshout JJ, Wieling W, Karemaker JM. Neural circulatory control in vasovagal syncope. Pacing Clin Electrophysiol 1997; 20: 753763.[CrossRef][Medline]
[17] Thomson HL, Atherton JJ, Khafagi FA, Frenneaux MP. Failure of reflex venoconstriction during exercise in patients with vasovagal syncope. Circulation 1996; 93: 953959.
[18] Dietz NM, Joyner MJ, Shepherd JT. Vasovagal syncope and skeletal muscle vasodilatation: the continuing conundrum. Pacing Clin Electrophysiol 1997; 20: 775780.[CrossRef][Medline]
[19] Lee TM, Chen MF, Su SF, Chao CL, Liau CS, Lee YT. Excessive myocardial contraction in vasovagal syncope demonstrated by echocardiography during head-up tilt. Clin Cardiol 1996; 19: 137140.[Web of Science][Medline]
[20] Sra JS, Murthy V, Natale A. Circulatory and catecholamine changes during head up tilt testing in neurocardiogenic (vasovagal) syncope. Am J Cardiol 1994; 73: 3337.[CrossRef][Web of Science][Medline]
[21] Petersen MEV, Williams TR, Erickson M, Sutton R. Right ventricular pressure, dP/dt, and preejection interval during tilt induced vasovagal syncope. Pacing Clin Electrophysiol 1997; 20: 806809.[CrossRef][Medline]
[22] Mosqueda-Garcia R, Furlan R, Violante RF, et al. Sympathetic and baroreceptor reflex function in neurally mediated syncope evoked by tilt. J Clin Invest 1997; 99: 27362744.[Web of Science][Medline]
[23] Ellenbogen KA, Morillo CA, Wood MA, Gilligan DM, Eckberg DL, Smith ML. Neural monitoring of vasovagal syncope. Pacing Clin Electrophysiol 1997; 20: 788794.[CrossRef][Medline]
[24] Quan KJ, Carlson MD, Thames MD. Mechanisms of heart rate and arterial blood pressure control: implications for the pathophysiology of neurocardiogenic syncope. Pacing Clin Electrophysiol 1997; 20: 764774.[CrossRef][Medline]
[25] Kenny RA, Ingram A, Bayliss J, Sutton R. Head up tilt: a useful tool for investigating unexplained syncope. Lancet 1986; 1: 13521355.[CrossRef][Web of Science][Medline]
[26] Fitzpatrick A, Theodorakis G, Vardas P, Sutton R. Methodology of head-up tilt testing in patients with unexplained syncope. J Am Coll Cardiol 1991; 17: 125130.[Abstract]
[27] Sheldon R, Splawinski J, Killam S. Reproducibility of isoproterenol tilt-table test in patients with syncope. Am J Cardiol 1992; 69: 13001305.[CrossRef][Web of Science][Medline]
[28] Bartoletti A, Alboni P, Ammirati F, et al. The Italian Protocol: a simplified head-up tilt testing potentiated with oral nitroglycein to assess patients with unexplained syncope. Europace 2000; 2: 339342.
[29] Brignole M, Menozzi C, Del Rosso A, et al. New classification of hemodynamics of vasovagal syncope: beyond the VASIS classification. Analysis of the pre-syncopal phase of the tilt test without and with nytroglicerin challenge. Europace 2000; 2: 6676.
[30] Ector H. Neurocardiogenic, vasovagal syncope (editorial). Eur Heart J 1999; 20: 16861687.
[31] Sutton R, Brignole M, Menozzi C, et al. Dual-chamber pacing in treatment of neurally-mediated tilt-positive cardioinhibitory syncope. Pacemaker versus no therapy: a multicentre randomized study. Circulation 2000; 102: 294299.
[32] Connolly SJ, Sheldon RS, Roberts RS, Gent M. The North American vasovagal pacemaker study. A randomised Trial of permanent cardiac pacing for prevention of vasovagal syncope. J Am Coll Cardiol 1999; 33: 1628.
[33] Ammirati F, Colivicchi F, Santini M. Permanent cardiac pacing versus medical treatment for the prevention of recurrent vasovagal syncope: a multicenter, randomized, controlled trial. Circulation 2001; 104: 5257.
[34] Deharo JC, Peyre JP, Ritter PH, Chalvidan T, Le Tallec L, Djiane P. Treatment of malignant primary vasodepressive neurocardiogenic syncope with rate responsive pacemaker driven by heart contractility. Pacing Clin Electrophysiol 1998; 21: 26882690.[CrossRef][Medline]
[35] Kosinski D, Grubb BP, Temesy-Armos P. Pathological aspects of neurocardiogenic syncope: Current concepts and new perspectives. Pacing Clin Electrophysiol 1995; 18: 716724.[CrossRef][Medline]
[36] Da Costa A, Ostermeier M, Schaldach M, et al. Closed loop pacing in a young patient with vasovagal syncope during tilt test (abs). Archives des Maladies du Couer et des Vaisseaux, tome 91, nr. Special III 1998; 48:.
[37] Guyomar Y, Graux P, Nicolas E, et al. INOS2 DR and neurocardiogenic syncope: a first experience about four patients. In Adornato E (Ed.). Rhythm Control from Cardiac Evaluation to Treatment 1998; Roma Edizioni Luigi Pozzi pp. 170175.
[38] Occhetta E, Bortnik M, Paffoni P, et al. Vasovagal syncope and closed loop stimulation: one year follow-up preliminary results. Progress in Biomedical Research 1999; 4:Suppl. A, 69.
[39] Grubb BP, Wolfe DA, Samoil D, Hahn H, Elliott L. Adaptive rate pacing controlled by right ventricular preejection interval for severe refractory orthostatic hypotension. Pacing Clin Electrophysiol 1993; 16: 801805.[CrossRef][Medline]
[40] Occhetta E, Bortnik M, Pedrigi C, et al. Vasovagal syncope: to pace or not to pace? Europace 2000; 1:Suppl D, 241.
[41] Occhetta E, Bortnik M, Audoglio R, et al. Sincope vasovagale e stimolazione CLS: risultati preliminari dello studio "INVASY". G Ital Aritmol Cardiostimol 2002; 5:Suppl. 2, 1920.
![]()
CiteULike
Connotea
Del.icio.us What's this?
This article has been cited by other articles:
![]() |
E. Occhetta, M. Bortnik, R. Audoglio, C. Vassanelli, and for the INVASY Study Investigators Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY): a multicentre randomized, single blind, controlled study Europace, January 1, 2004; 6(6): 538 - 547. [Abstract] [Full Text] [PDF] |
||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
