Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY): A multicentre randomized, single blind, controlled study

Eraldo Occhetta; Miriam Bortnik; Roberto Audoglio; Corrado Vassanelli; Pierluigi Roncarolo; Leandro Chiodi; Marco Marcolongo; Davide Torta; Marco Zanetta; Guiseppe Boriani; Raimondo Pirisi; Antonio Mazza; Paolo Marconi; Diran Igidbashian; Salvatore Romano; Ruggero Manfredini; Claudio Tondo; Massimo Arlotti; Marcello Chimienti; Luigi Zamparelli; Luciano Cioffi; Angelo Carboni; Maria Grazia Bongiorni; Rocco Polimeni; Sergio Sermasi; Giovanni Del Giudice; Adriano Croce; Giovanni Batista Tola; Pierfranco Terrosu; Paolo Bellotti; Massimo Gazzarata; Luigi Libero; Marcella Jorfida; Mauro Bensoni; Daniela Barbieri; Sergio Lombroso; Antonio Galati; Jorge Salerno; Salvatore Caico; Enzo Maria Bianchi; Renato Glenzer; Francesco Zolezzi; Roberto Negro; Massimo Sassara; Fernando De Luca

doi:10.1016/j.eupc.2004.08.009

Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY): A multicentre randomized, single blind, controlled study

Eraldo Occhetta, Miriam Bortnik, Roberto Audoglio, Corrado Vassanelli, Pierluigi Roncarolo, Leandro Chiodi, Marco Marcolongo, Davide Torta, Marco Zanetta, Guiseppe Boriani, Raimondo Pirisi, Antonio Mazza, Paolo Marconi, Diran Igidbashian, Salvatore Romano, Ruggero Manfredini, Claudio Tondo, Massimo Arlotti, Marcello Chimienti, Luigi ZamparelliLuciano Cioffi, Angelo Carboni, Maria Grazia Bongiorni, Rocco Polimeni, Sergio Sermasi, Giovanni Del Giudice, Adriano Croce, Giovanni Batista Tola, Pierfranco Terrosu, Paolo Bellotti, Massimo Gazzarata, Luigi Libero, Marcella Jorfida, Mauro Bensoni, Daniela Barbieri, Sergio Lombroso, Antonio Galati, Jorge Salerno, Salvatore Caico, Enzo Maria Bianchi, Renato Glenzer, Francesco Zolezzi, Roberto Negro, Massimo Sassara, Fernando De Luca

Centro Cardiologico Monzino

Research output: Contribution to journal › Article › peer-review

Abstract

Objectives: To determine whether dual-chamber rate-adaptive Closed Loop Stimulation (CLS) could prevent recurrence of Vasovagal Syncope (VVS). Background: During VVS, an increase in myocardial contractility associated with a reduction of ventricular filling produces an increase in baroreceptor afferent flow and a consequent decrease in the heart rate. The CLS algorithm is a form of rate-adaptive pacing, which responds to myocardial contraction dynamics, by measuring variations in right ventricular intracardiac impedance: during an incipient VVS it could increase paced heart rate and avoid bradycardia, arterial hypotension and syncope. Methods: Fifty patients (27 males, mean age 59 ± 18 year) with severe and recurrent vasovagal syncope and positive Head Up Tilt Test (HUTT) with cardioinhibition, received a CLS pacemaker (INOS², Biotronik GmbH Co., Germany). The primary end point was recurrence of two VVSs during a minimum of 1 year of follow-up. Randomization between DDD-CLS and DDI mode (40 bpm) pacing was performed only during the first stage of the study (first year): 9/26 randomized to DDI mode (control group) and 17/26 in DDD-CLS mode. All the 24 patients recruited in the second stage of the study (second year) were programmed in DDD-CLS mode. Results: Of the nine patients randomized to the DDI mode, seven had recurrences of syncope during the first year. At the end of the first year the nine patients were reprogrammed to the CLS mode and no syncope occurred after reprogramming. The 41 patients programmed to CLS had a mean follow-up of 19 ± 4 months: none reported VVS, only four (10%) reported occasional presyncope and their quality of life greatly improved. Positive HUTT at the end of the first year failed to predict the clinical response to CLS pacing. Conclusions: The study demonstrates the effectiveness of CLS pacing in preventing cardioinhibitory VVS. A possible placebo effect of pacemaker implantation occurred in 22% of patients.

Original language	English
Pages (from-to)	538-547
Number of pages	10
Journal	Europace
Volume	6
Issue number	6
DOIs	https://doi.org/10.1016/j.eupc.2004.08.009
Publication status	Published - Nov 2004

Keywords

Closed loop stimulation
DDD pacing
Vasovagal syncope

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.eupc.2004.08.009

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Occhetta, E., Bortnik, M., Audoglio, R., Vassanelli, C., Roncarolo, P., Chiodi, L., Marcolongo, M., Torta, D., Zanetta, M., Boriani, G., Pirisi, R., Mazza, A., Marconi, P., Igidbashian, D., Romano, S., Manfredini, R., Tondo, C., Arlotti, M., Chimienti, M., ... De Luca, F. (2004). Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY): A multicentre randomized, single blind, controlled study. Europace, 6(6), 538-547. https://doi.org/10.1016/j.eupc.2004.08.009

Occhetta, E, Bortnik, M, Audoglio, R, Vassanelli, C, Roncarolo, P, Chiodi, L, Marcolongo, M, Torta, D, Zanetta, M, Boriani, G, Pirisi, R, Mazza, A, Marconi, P, Igidbashian, D, Romano, S, Manfredini, R, Tondo, C, Arlotti, M, Chimienti, M, Zamparelli, L, Cioffi, L, Carboni, A, Bongiorni, MG, Polimeni, R, Sermasi, S, Del Giudice, G, Croce, A, Batista Tola, G, Terrosu, P, Bellotti, P, Gazzarata, M, Libero, L, Jorfida, M, Bensoni, M, Barbieri, D, Lombroso, S, Galati, A, Salerno, J, Caico, S, Bianchi, EM, Glenzer, R, Zolezzi, F, Negro, R, Sassara, M & De Luca, F 2004, 'Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY): A multicentre randomized, single blind, controlled study', Europace, vol. 6, no. 6, pp. 538-547. https://doi.org/10.1016/j.eupc.2004.08.009

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title = "Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY): A multicentre randomized, single blind, controlled study",

abstract = "Objectives: To determine whether dual-chamber rate-adaptive Closed Loop Stimulation (CLS) could prevent recurrence of Vasovagal Syncope (VVS). Background: During VVS, an increase in myocardial contractility associated with a reduction of ventricular filling produces an increase in baroreceptor afferent flow and a consequent decrease in the heart rate. The CLS algorithm is a form of rate-adaptive pacing, which responds to myocardial contraction dynamics, by measuring variations in right ventricular intracardiac impedance: during an incipient VVS it could increase paced heart rate and avoid bradycardia, arterial hypotension and syncope. Methods: Fifty patients (27 males, mean age 59 ± 18 year) with severe and recurrent vasovagal syncope and positive Head Up Tilt Test (HUTT) with cardioinhibition, received a CLS pacemaker (INOS2, Biotronik GmbH Co., Germany). The primary end point was recurrence of two VVSs during a minimum of 1 year of follow-up. Randomization between DDD-CLS and DDI mode (40 bpm) pacing was performed only during the first stage of the study (first year): 9/26 randomized to DDI mode (control group) and 17/26 in DDD-CLS mode. All the 24 patients recruited in the second stage of the study (second year) were programmed in DDD-CLS mode. Results: Of the nine patients randomized to the DDI mode, seven had recurrences of syncope during the first year. At the end of the first year the nine patients were reprogrammed to the CLS mode and no syncope occurred after reprogramming. The 41 patients programmed to CLS had a mean follow-up of 19 ± 4 months: none reported VVS, only four (10%) reported occasional presyncope and their quality of life greatly improved. Positive HUTT at the end of the first year failed to predict the clinical response to CLS pacing. Conclusions: The study demonstrates the effectiveness of CLS pacing in preventing cardioinhibitory VVS. A possible placebo effect of pacemaker implantation occurred in 22% of patients.",

keywords = "Closed loop stimulation, DDD pacing, Vasovagal syncope",

author = "Eraldo Occhetta and Miriam Bortnik and Roberto Audoglio and Corrado Vassanelli and Pierluigi Roncarolo and Leandro Chiodi and Marco Marcolongo and Davide Torta and Marco Zanetta and Guiseppe Boriani and Raimondo Pirisi and Antonio Mazza and Paolo Marconi and Diran Igidbashian and Salvatore Romano and Ruggero Manfredini and Claudio Tondo and Massimo Arlotti and Marcello Chimienti and Luigi Zamparelli and Luciano Cioffi and Angelo Carboni and Bongiorni, {Maria Grazia} and Rocco Polimeni and Sergio Sermasi and {Del Giudice}, Giovanni and Adriano Croce and {Batista Tola}, Giovanni and Pierfranco Terrosu and Paolo Bellotti and Massimo Gazzarata and Luigi Libero and Marcella Jorfida and Mauro Bensoni and Daniela Barbieri and Sergio Lombroso and Antonio Galati and Jorge Salerno and Salvatore Caico and Bianchi, {Enzo Maria} and Renato Glenzer and Francesco Zolezzi and Roberto Negro and Massimo Sassara and {De Luca}, Fernando",

year = "2004",

month = nov,

doi = "10.1016/j.eupc.2004.08.009",

language = "English",

volume = "6",

pages = "538--547",

journal = "Europace",

issn = "1099-5129",

publisher = "Oxford University Press",

number = "6",

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TY - JOUR

T1 - Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY)

T2 - A multicentre randomized, single blind, controlled study

AU - Occhetta, Eraldo

AU - Bortnik, Miriam

AU - Audoglio, Roberto

AU - Vassanelli, Corrado

AU - Roncarolo, Pierluigi

AU - Chiodi, Leandro

AU - Marcolongo, Marco

AU - Torta, Davide

AU - Zanetta, Marco

AU - Boriani, Guiseppe

AU - Pirisi, Raimondo

AU - Mazza, Antonio

AU - Marconi, Paolo

AU - Igidbashian, Diran

AU - Romano, Salvatore

AU - Manfredini, Ruggero

AU - Tondo, Claudio

AU - Arlotti, Massimo

AU - Chimienti, Marcello

AU - Zamparelli, Luigi

AU - Cioffi, Luciano

AU - Carboni, Angelo

AU - Bongiorni, Maria Grazia

AU - Polimeni, Rocco

AU - Sermasi, Sergio

AU - Del Giudice, Giovanni

AU - Croce, Adriano

AU - Batista Tola, Giovanni

AU - Terrosu, Pierfranco

AU - Bellotti, Paolo

AU - Gazzarata, Massimo

AU - Libero, Luigi

AU - Jorfida, Marcella

AU - Bensoni, Mauro

AU - Barbieri, Daniela

AU - Lombroso, Sergio

AU - Galati, Antonio

AU - Salerno, Jorge

AU - Caico, Salvatore

AU - Bianchi, Enzo Maria

AU - Glenzer, Renato

AU - Zolezzi, Francesco

AU - Negro, Roberto

AU - Sassara, Massimo

AU - De Luca, Fernando

PY - 2004/11

Y1 - 2004/11

N2 - Objectives: To determine whether dual-chamber rate-adaptive Closed Loop Stimulation (CLS) could prevent recurrence of Vasovagal Syncope (VVS). Background: During VVS, an increase in myocardial contractility associated with a reduction of ventricular filling produces an increase in baroreceptor afferent flow and a consequent decrease in the heart rate. The CLS algorithm is a form of rate-adaptive pacing, which responds to myocardial contraction dynamics, by measuring variations in right ventricular intracardiac impedance: during an incipient VVS it could increase paced heart rate and avoid bradycardia, arterial hypotension and syncope. Methods: Fifty patients (27 males, mean age 59 ± 18 year) with severe and recurrent vasovagal syncope and positive Head Up Tilt Test (HUTT) with cardioinhibition, received a CLS pacemaker (INOS2, Biotronik GmbH Co., Germany). The primary end point was recurrence of two VVSs during a minimum of 1 year of follow-up. Randomization between DDD-CLS and DDI mode (40 bpm) pacing was performed only during the first stage of the study (first year): 9/26 randomized to DDI mode (control group) and 17/26 in DDD-CLS mode. All the 24 patients recruited in the second stage of the study (second year) were programmed in DDD-CLS mode. Results: Of the nine patients randomized to the DDI mode, seven had recurrences of syncope during the first year. At the end of the first year the nine patients were reprogrammed to the CLS mode and no syncope occurred after reprogramming. The 41 patients programmed to CLS had a mean follow-up of 19 ± 4 months: none reported VVS, only four (10%) reported occasional presyncope and their quality of life greatly improved. Positive HUTT at the end of the first year failed to predict the clinical response to CLS pacing. Conclusions: The study demonstrates the effectiveness of CLS pacing in preventing cardioinhibitory VVS. A possible placebo effect of pacemaker implantation occurred in 22% of patients.

AB - Objectives: To determine whether dual-chamber rate-adaptive Closed Loop Stimulation (CLS) could prevent recurrence of Vasovagal Syncope (VVS). Background: During VVS, an increase in myocardial contractility associated with a reduction of ventricular filling produces an increase in baroreceptor afferent flow and a consequent decrease in the heart rate. The CLS algorithm is a form of rate-adaptive pacing, which responds to myocardial contraction dynamics, by measuring variations in right ventricular intracardiac impedance: during an incipient VVS it could increase paced heart rate and avoid bradycardia, arterial hypotension and syncope. Methods: Fifty patients (27 males, mean age 59 ± 18 year) with severe and recurrent vasovagal syncope and positive Head Up Tilt Test (HUTT) with cardioinhibition, received a CLS pacemaker (INOS2, Biotronik GmbH Co., Germany). The primary end point was recurrence of two VVSs during a minimum of 1 year of follow-up. Randomization between DDD-CLS and DDI mode (40 bpm) pacing was performed only during the first stage of the study (first year): 9/26 randomized to DDI mode (control group) and 17/26 in DDD-CLS mode. All the 24 patients recruited in the second stage of the study (second year) were programmed in DDD-CLS mode. Results: Of the nine patients randomized to the DDI mode, seven had recurrences of syncope during the first year. At the end of the first year the nine patients were reprogrammed to the CLS mode and no syncope occurred after reprogramming. The 41 patients programmed to CLS had a mean follow-up of 19 ± 4 months: none reported VVS, only four (10%) reported occasional presyncope and their quality of life greatly improved. Positive HUTT at the end of the first year failed to predict the clinical response to CLS pacing. Conclusions: The study demonstrates the effectiveness of CLS pacing in preventing cardioinhibitory VVS. A possible placebo effect of pacemaker implantation occurred in 22% of patients.

KW - Closed loop stimulation

KW - DDD pacing

KW - Vasovagal syncope

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ER -

Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY): A multicentre randomized, single blind, controlled study

Abstract

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