The effect of dual-chamber closed-loop stimulation on syncope recurrence in healthy patients with tilt-induced vasovagal cardioinhibitory syncope: a prospective, randomised, single-blind, crossover study

Russo, Vincenzo; Rago, Anna; Papa, Andrea Antonio; Golino, Paolo; Calabrò, Raffaele; Russo, Maria Giovanna; Nigro, Gerardo

doi:10.1136/heartjnl-2013-303878

Cited by 47 publications

(42 citation statements)

References 22 publications

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“…31 More recent studies demonstrated significant improvement in syncope recurrence with DDD with a closed-loop stimulation algorithm (DDD-CLS; Biotronik) compared to standard DDD pacing in asystolic tilt-positive VVS. 32 Further studies of pacing in patients >40 years with recurrent VVS are ongoing. 33 While CLS pacing may be more effective than other forms of pacing, there have not been any trials comparing CLS pacing to non-CLS pacing for the reduction of VVS.…”

Section: Vasovagal Syncopementioning

confidence: 99%

Autonomic Dysfunction in Cardiology: Pathophysiology, Investigation, and Management

Arnold

Lei

et al. 2017

Canadian Journal of Cardiology

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Presyncope and syncope are common medical findings, with greater than 40% estimated lifetime prevalence. These conditions are often elicited by postural stress and can be recurrent and accompanied by debilitating symptoms of cerebral hypoperfusion. Therefore, it is critical for physicians to become familiar with diagnosis and treatment of common underlying causes of presyncope and syncope. In some patients, altered postural hemodynamic responses are due to failure of compensatory autonomic nervous system reflex mechanisms. The most common presentations of presyncope and syncope secondary to this autonomic dysfunction include vasovagal syncope, neurogenic orthostatic hypotension, and postural tachycardia syndrome. The most sensitive method for diagnosis is a detailed initial evaluation with medical history, physical examination, and resting electrocardiogram to rule out cardiac syncope. Physical examination should include measurement of supine and standing blood pressure and heart rate, to identify the pattern of hemodynamic regulation during orthostatic stress. Additional testing may be required in patients without clear diagnosis following initial evaluation. Management of patients should focus on improving symptoms and functional status, and not targeting arbitrary hemodynamic values. An individualized structured and stepwise approach should be taken for treatment starting with patient education, lifestyle modifications, and use of physical counter-pressure maneuvers and devices to improve venous return. Pharmacological interventions should only be added when conservative approaches are insufficient to improve symptoms. There are no gold standard approaches for pharmacological treatment in these conditions, with medications often used off-label and with limited long-term data for effectiveness.

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Section: Vasovagal Syncopementioning

confidence: 99%

Autonomic Dysfunction in Cardiology: Pathophysiology, Investigation, and Management

Arnold

Lei

et al. 2017

Canadian Journal of Cardiology

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“…El estudio más reciente con empleo de marcapasos con CLS para el manejo de síncope vasovagal con respuesta cardioinhibitoria en la mesa basculante se llevó a cabo en una población de pacientes sin otras comorbilidades, con un diseño cruzado, que involucró a 50 pacientes con un seguimiento de 36 meses y halló una reducción significativa en el número de síncopes y de presíncopes 33 .…”

Section: Estimulación Convencional Frente a Sistema De Asa Cerradaunclassified

Tratamiento del síncope neuralmente mediado con marcapasos: utilidad del sensor de asa cerrada

Ossa

Duque

2015

Revista Colombiana de Cardiología

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Recibido el 4 de junio de 2014; aceptado el 17 de octubre de 2014 Disponible en Internet el 11 de marzo de 2015 PALABRAS CLAVE Marcapasos; Síncope; Estimulación ventricularResumen El síncope vasovagal es una entidad frecuente, de difícil manejo, con alta tasa de recurrencia aun con manejo médico. Se ha estudiado la estimulación cardiaca en pacientes con respuesta cardioinhibitoria en la mesa basculante con resultados contradictorios. Los estudios iniciales mostraron buenos resultados, que no lograron reproducirse cuando se introdujo el diseño doble ciego. La mayoría de estos estudios se realizaron con marcapasos con sensores convencionales. Las guías actuales de dispositivos indican la terapia de estimulación cardiaca en síncope vasovagal con respuesta cardioinhibitoria como una alternativa ante la no respuesta al tratamiento convencional. Existe evidencia reciente que indica que los marcapasos con sensores de asa cerrada (CLS, del inglés closed-loop sensor) muestran mejores resultados que los sensores convencionales; estos estudios, aunque con población pequeña, reportan reducciones de la frecuencia de síncopes y presíncopes. Este tipo de dispositivos actúan en etapas más tempranas de la cascada de eventos fisiopatológicos del síncope vasovagal, detectando cambios en la impedancia ventricular antes de la caída de la frecuencia cardiaca, lo cual permite intervenir en forma precoz con estimulación para evitar el síncope. Neurally mediated syncope treatment with pacemakers: Utility of closed-loop sensorAbstract The vasovagal syncope is a frequent entity of difficult management with a high rate of recurrence despite medical management. Cardiac pacing has been studied in patients with cardioinhibitory response on tilt table with inconsistent results. Initial studies showed beneficial results were achieved, but they could be reproduced when the double-blind design was introduced. Most of these studies were performed with conventional pacemaker sensors. Device current guidelines indicate pacing therapy in vasovagal syncope with cardioinhibitory response * Autor para correspondencia. Correo electrónico: mauricioduque@une.net.co (M. Duque).

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“…Each of these was reviewed by 2 ERC members, with a third member providing adjudication in cases of discordance. After full-text review, 10 studies, 4,6,7,[9][10][11][12][13][14]25 including a total of 676 adult patients with vasovagal, situational, and/or carotid sinus hypersensitivity syncope, that compared pacing to pacing off (or no pacemaker) and had at least 1 year of follow-up were included in the systematic review.…”

Section: Study Selectionmentioning

confidence: 99%

“…9 Patients were randomly assigned to closed-loop stimulation (CLS) programmed "on" or "off," and then after 18 months and a subsequent 1-month washout period, patients were crossed …”

Section: Studies Addressing Vasovagal Syncopementioning

confidence: 99%

“…Studies have presented mixed results in terms of the benefits of pacemakers in patients with reflex-mediated syncope, with some suggesting benefit [4][5][6][7][8][9] and others suggesting either no benefit or unclear benefit. [10][11][12][13][14][15] A 2007 systematic review found significant heterogeneity and concern about an "expectation effect," a form of outcome ascertainment bias based on the awareness of the presence of a pacemaker in unblinded trials, when no benefit was seen in double-blinded trials.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Pacing as a Treatment for Reflex-Mediated (Vasovagal, Situational, or Carotid Sinus Hypersensitivity) Syncope: A Systematic Review for the 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society

Varosy¹,

Chen²,

Miller³

et al. 2017

Circulation

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OBJECTIVES: To determine, using systematic review of the biomedical literature, whether pacing reduces risk of recurrent syncope and relevant clinical outcomes among adult patients with reflexmediated syncope. Trials (through October 7, 2015) were searched for randomized trials and observational studies examining pacing and syncope, and the bibliographies of known systematic reviews were also examined. Studies were rejected for poor-quality study methods and for the lack of the population, intervention, comparator, or outcome(s) of interest. METHODS: MEDLINE (through PubMed), EMBASE, and the Cochrane Central Register of Controlled RESULTS:Of 3188 citations reviewed, 10 studies met the inclusion criteria for systematic review, including a total of 676 patients. These included 9 randomized trials and 1 observational study. Of the 10 studies, 4 addressed patients with carotid sinus hypersensitivity, and the remaining 6 addressed vasovagal syncope. Among the 6 open-label (unblinded) studies, we found that pacing was associated with a 70% reduction in recurrent syncope (relative risk [RR]: 0.30; 95% confidence interval [CI]: 0.15-0.60). When the 2 analyzable studies with double-blinded methodology were considered separately, there was no clear benefit (RR: 0.73; 95% CI: 0.25-2.1), but confidence intervals were wide. The strongest evidence was from the randomized, double-blinded ISSUE-3 (Third International Study on Syncope of Uncertain Etiology) trial, which demonstrated a benefit of pacing among patients with recurrent syncope and asystole documented by implantable loop recorder. CONCLUSIONS:There are limited data with substantive evidence of outcome ascertainment bias, and only 2 studies with a double-blinded study design have been conducted. The evidence does not support the use of pacing for reflex-mediated syncope beyond patients with recurrent vasovagal syncope and asystole documented by implantable loop recorder.

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The effect of dual-chamber closed-loop stimulation on syncope recurrence in healthy patients with tilt-induced vasovagal cardioinhibitory syncope: a prospective, randomised, single-blind, crossover study

Abstract: Based on these 36 months follow-up data, it is concluded that dual-chamber CLS is an effective algorithm for preventing syncope recurrences in healthy patients with tilt-induced vasovagal cardioinhibitory syncope.

Cited by 47 publications

References 22 publications

Autonomic Dysfunction in Cardiology: Pathophysiology, Investigation, and Management

Autonomic Dysfunction in Cardiology: Pathophysiology, Investigation, and Management

Tratamiento del síncope neuralmente mediado con marcapasos: utilidad del sensor de asa cerrada

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