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Journal ArticleDOI

Time-to-first appropriate shock in patients implanted prophylactically with an implantable cardioverter-defibrillator: data from the Survey on Arrhythmic Events in BRUgada Syndrome (SABRUS)

01 May 2019-Europace (Oxford University Press)-Vol. 21, Iss: 5, pp 796-802

TL;DR: First appropriate therapy in BrS patients with prophylactic ICD's occurred during the first 5 years in 76.6% of patients and Syncope and spontaneous Type 1 Brugada ECG correlated with a shorter time to ICD therapy.

AbstractAims: Data on predictors of time-to-first appropriate implantable cardioverter-defibrillator (ICD) therapy in patients with Brugada Syndrome (BrS) and prophylactically implanted ICD's are scarce. Methods and results: SABRUS (Survey on Arrhythmic Events in BRUgada Syndrome) is an international survey on 678 BrS patients who experienced arrhythmic event (AE) including 252 patients in whom AE occurred after prophylactic ICD implantation. Analysis was performed on time-to-first appropriate ICD discharge regarding patients' characteristics. Multivariate logistic regression models were utilized to identify which parameters predicted time to arrhythmia ≤5 years. The median time-to-first appropriate ICD therapy was 24.8 ± 2.8 months. A shorter time was observed in patients from Asian ethnicity (P < 0.05), those with syncope (P = 0.001), and those with Class IIa indication for ICD (P = 0.001). A longer time was associated with a positive family history of sudden cardiac death (P < 0.05). Multivariate Cox regression revealed shorter time-to-ICD therapy in patients with syncope [odds ratio (OR) 1.65, P = 0.001]. In 193 patients (76.6%), therapy was delivered during the first 5 years. Factors associated with this time were syncope (OR 0.36, P = 0.001), spontaneous Type 1 Brugada electrocardiogram (ECG) (OR 0.5, P < 0.05), and Class IIa indication (OR 0.38, P < 0.01) as opposed to Class IIb (OR 2.41, P < 0.01). A near-significant trend for female gender was also noted (OR 0.13, P = 0.052). Two score models for prediction of <5 years to shock were built. Conclusion: First appropriate therapy in BrS patients with prophylactic ICD's occurred during the first 5 years in 76.6% of patients. Syncope and spontaneous Type 1 Brugada ECG correlated with a shorter time to ICD therapy.

Summary (2 min read)

INTRODUCTION

  • Brugada syndrome (Brs) is a well-recognized cause of sudden cardiac death (SCD) particularly in apparently healthy middle-aged males(1).
  • The cause of death is a ventricular tachyarrhythmia usually occurring without precipitating warning signs(2) .
  • Most clinical research on this potentially lethal arrhythmic disease has mainly focused on risk stratification to identify patients at risk who will benefit from an implanted cardioverter-defibrillator (ICD), the most advocated option to prevent SCD.
  • Present indications for prophylactic ICD implantation in patients with BrS-ECG include(3): 1) Spontaneous type 1 Brugada-ECG pattern and a history of syncope (class IIa indication); 2) Spontaneous or drug-induced type 1 Brugada-ECG with induction of ventricular fibrillation during programmed ventricular stimulation with 2 or 3 extrastimuli (class IIb indication).
  • When a patient is identified as complying with these guideline recommendations(3), the most appropriate timing of the implantation is unknown with a double-edged sword decision for implant: too early might expose the patient to possible complications whereas too late might have a detrimental outcome.

METHODS

  • In 426 patients (group A), the AE was documented during aborted CA while in 252 patients (group B) the AE was documented from an ICD implanted prophylactically following conventional class IIa or IIb indications(3) (75% of patients) or non-class IIa or IIb indications (25% of patients)(2).
  • Group B patients comprised the study group of the present study.
  • The study was approved by the Research Ethics Boards of all participating institutions.

Methods.

  • SABRUS is an international survey on 678 BrS-patients who experienced arrhythmic event (AE) including 252 patients in whom AE occurred after prophylactic ICD implantation.
  • The median time-to-first appropriate ICD therapy was 24.8±2.8 months.
  • A longer time was associated with a positive family history of sudden cardiac death (p<0.05).
  • Two score models for prediction of <5 years to shock were built.
  • Syncope and spontaneous type 1 Brugada-ECG correlated with a shorter time to ICD therapy.

DATA ACQUISITION.

  • AE was defined as any sustained ventricular tachyarrhythmia triggering appropriate ICD shock therapy, also known as Arrhythmic events.
  • Taking into consideration the aforementioned patients’ characteristics predicting a time-to-shock < 5 years, their relative odds ratio, and parameter significance, two risks scores were built.
  • One point is given for either prior syncope or the presence of a spontaneous type 1 Brugada-ECG, and for the gender augmented score - 2 points were added for female gender.
  • A score of 0 was found in 50.0% of patients using the minimal score and in 46.4% of patients using the gender augmented score.

Time-to-shock.

  • The literature regarding the time-to-first appropriate shock therapy in BrS patients implanted prophylactically with an ICD is scarce.
  • In the present study which involved the largest cohort population with AEs documented after prophylactic ICD implantation (n=252), the median time-to-shock was 24.8 months.
  • By multivariate logistic regression the presence of syncope was found to correlate with a shorter time-to-shock (19.5±2.5 months vs. 36.5±4.9 months in asymptomatic patients, P<0.001).
  • One possible explanation could be a biased decision taken by the referring patient’s physician who considered a family history of SCD as a major risk factor.
  • In their recent paper(9) the authors discussed several factors suggesting a more aggressive course of the disease in females.

Time-to-shock Score

  • The time-to-shock score was created to help the identification of patients who will need an ICD implant with the shortest delays.
  • Because female gender had a borderline significance (p=0.052), which could be a result of the low number of 17 females included in the study, the authors created two scores one including gender and one excluding it.
  • Both scores showed high prediction rates for AE ≤ 5 years after ICD implant, yet the gender augmented score showed a more significant trend with a higher predictive value for the maximal score (85% for the maximal score in the minimal scoring system vs. 100% for the gender augmented system).
  • The present study by nature is a retrospective cumulative analysis of results from the largest EP-centers with experience with BrS.
  • Two factors (syncope and spontaneous type 1 BrS-ECG) were found to be associated with this time-to-shock delay.

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Europace
Time-to-First Appropriate Shock in Patients Implanted Prophylactically with an
Implantable Cardioverter Defibrillator:
Data from the Survey on Arrhythmic Events in BRUgada Syndrome (SABRUS)
--Manuscript Draft--
Manuscript Number: EUPC-D-18-01041R1
Full Title: Time-to-First Appropriate Shock in Patients Implanted Prophylactically with an
Implantable Cardioverter Defibrillator:
Data from the Survey on Arrhythmic Events in BRUgada Syndrome (SABRUS)
Article Type: Clinical Research
Keywords: Brugada syndrome; ICD; appropriate therapy; arrhythmic event
Corresponding Author: Anat Milman, MD PhD
Tel Aviv Sourasky Medical Center
Tel Aviv, ISRAEL
Corresponding Author Secondary
Information:
Corresponding Author's Institution: Tel Aviv Sourasky Medical Center
Corresponding Author's Secondary
Institution:
Tel Aviv University Sackler Faculty of Medicine
First Author: Anat Milman, MD PhD
First Author Secondary Information:
Order of Authors: Anat Milman, MD PhD
Aviram Hochstadt, MD
Antoine Andorin, MD
Jean-Baptiste Gourraud, MD, PhD
Frederic Sacher, MD
Philippe Mabo, MD
Sung-Hwan Kim, MD
Giulio Conte, MD, PhD
Elena Arbelo, MD, PhD
Tsukasa Kamakura, MD, PhD
Takeshi Aiba, MD, PhD
Carlo Napolitano, MD, PhD
Carla Giustetto, MD
Isabelle Denjoy, MD
Jimmy JM Juang, MD, PhD
Shingo Maeda, MD, PhD
Yoshihide Takahashi, MD, PhD
Eran Leshem, MD
Yoav Michowitz, MD
Michael Rahkovich, MD
Camilla H. Jespersen, MD
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Yanushi D. Wijeyeratne, MD
Jean Champagne, MD
Leonardo Calo, MD
Zhengrong Huang, MD, PhD
Yuka Mizusawa, MD
Pieter G. Postema, MD, PhD
Ramon Brugada, MD, PhD
Arthur A.M. Wilde, MD, PhD
Gan-Xin Yan, MD, PhD
Elijah R. Behr, MD
Jacob Tfelt-Hansen, MD, DMSc
Kenzo Hirao, MD, PhD
Christian Veltmann, MD
Antoine Leenhardt, MD
Domenico Corrado, MD, PhD
Fiorenzo Gaita, MD
Silvia G. Priori, MD, PhD
Kengo F. Kusano, MD, PhD
Masahiko Takagi, MD, PhD
Pietro Delise, MD
Josep Brugada, MD, PhD
Pedro Brugada, MD, PhD
Gi-Byoung Nam, MD, PhD
Vincent Probst, MD, PhD
Bernard Belhassen, MD
Order of Authors Secondary Information:
Abstract: Aims.
Data on predictors of time-to-first appropriate ICD therapy in patients with Brugada
syndrome (BrS) and prophylactically implanted ICD’s are scarce.
Methods.
SABRUS is an international survey on 678 BrS-patients who experienced arrhythmic
event (AE) including 252 patients in whom AE occurred after prophylactic ICD
implantation. Analysis was performed on time-to-first appropriate ICD discharge
regarding patients’ characteristics. Multivariate logistic regression models were utilized
to identify which parameters predicted time to arrhythmia ≤ 5 years.
Results.
The median time-to-first appropriate ICD therapy was 24.8±2.8 months. A shorter time
was observed in patients from Asian ethnicity (p<0.05), those with syncope (p=0.001)
and those with class IIa indication for ICD (p=0.001). A longer time was associated with
a positive family history of sudden cardiac death (p<0.05). Multivariate Cox regression
revealed shorter time-to-ICD therapy in patients with syncope (OR 1.65, P=0.001). In
193 patients (76.6%), therapy was delivered during the first 5 years. Factors
associated with this time were syncope (OR 0.36, p=0.001), spontaneous type 1
Brugada ECG (OR 0.5, p<0.05) and class IIa indication (OR 0.38, p<0.01) as opposed
to class IIb (OR 2.41, p<0.01). A near-significant trend for female gender was also
noted (OR 0.13, p=0.052). Two score models for prediction of <5 years to shock were
built.
Conclusions.
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First appropriate therapy in BrS-patients with prophylactic ICD’s occurred during the
first 5 years in 76.6% of patients. Syncope and spontaneous type 1 Brugada-ECG
correlated with a shorter time to ICD therapy.
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'What's New?'
1. In patients with BrS who had an appropriate shock from a prophylactically implanted
ICD, the great majority (76.6%) received this shock during the first 5 years after ICD
implantation.
2. Clinical parameters predicting a shorter time to appropriate shock were syncope and
a spontaneous type 1 ECG. A near-significant trend for female gender was also
noted.
3. Two score models were built using these parameters to predict the time to first AE
and will need to be validated in future studies.
"What's New"

ABSTRACT
Aims.
Data on predictors of time-to-first appropriate ICD therapy in patients with Brugada
syndrome (BrS) and prophylactically implanted ICD’s are scarce.
Methods.
SABRUS is an international survey on 678 BrS-patients who experienced arrhythmic event
(AE) including 252 patients in whom AE occurred after prophylactic ICD implantation.
Analysis was performed on time-to-first appropriate ICD discharge regarding patients’
characteristics. Multivariate logistic regression models were utilized to identify which
parameters predicted time to arrhythmia 5 years.
Results.
The median time-to-first appropriate ICD therapy was 24.8±2.8 months. A shorter time was
observed in patients from Asian ethnicity (p<0.05), those with syncope (p=0.001) and those
with class IIa indication for ICD (p=0.001). A longer time was associated with a positive
family history of sudden cardiac death (p<0.05). Multivariate Cox regression revealed
shorter time-to-ICD therapy in patients with syncope (OR 1.65, P=0.001). In 193 patients
(76.6%), therapy was delivered during the first 5 years. Factors associated with this time
were syncope (OR 0.36, p=0.001), spontaneous type 1 Brugada ECG (OR 0.5, p<0.05) and
class IIa indication (OR 0.38, p<0.01) as opposed to class IIb (OR 2.41, p<0.01). A near-
significant trend for female gender was also noted (OR 0.13, p=0.052). Two score models for
prediction of <5 years to shock were built.
Conclusions.
First appropriate therapy in BrS-patients with prophylactic ICD’s occurred during the first 5
Abstract and Keywords

Figures (12)
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References
More filters

Journal ArticleDOI
TL;DR: This poster presents a probabilistic procedure to determine the best method for selecting a single drug to treat atrial fibrillation-like symptoms in patients with a history of atrialfibrillation.
Abstract: 2015 ESC Guidelines for the Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death

1,616 citations


"Time-to-first appropriate shock in ..." refers background or methods in this paper

  • ...When a patient is identified as complying with these guideline recommendations(3), the most appropriate timing of the...

    [...]

  • ...Present indications for prophylactic ICD implantation in patients with BrS-ECG include(3): 1) Spontaneous type 1 Brugada-ECG pattern and a history of syncope (class IIa indication); 2) Spontaneous or drug-induced type 1 Brugada-ECG with induction of ventricular fibrillation during programmed ventricular stimulation with 2 or 3 extrastimuli (class IIb indication)....

    [...]

  • ...In 426 patients (group A), the AE was documented during aborted CA while in 252 patients (group B) the AE was documented from an ICD implanted prophylactically following conventional class IIa or IIb indications(3) (75% of patients) or non-class IIa or IIb indications (25% of patients)(2)....

    [...]

  • ...In respect to the conventional indications of prophylactic ICD implantation (3), the shortest median time-to-shock was observed in the class IIa subgroup (17....

    [...]

  • ...When a patient is identified as complying with these guideline recommendations(3), the most appropriate timing of the implantation is unknown with a double-edged sword decision for implant: too early might expose the patient to possible complications whereas too late might have a detrimental outcome....

    [...]



Journal ArticleDOI
TL;DR: Authors/Task Force Members: Silvia G. Priori (Chairperson), Carina Blomström-Lundqvist (Co-chairperson) (Sweden), Andrea Mazzanti† (Italy), Nico Blom (The Netherlands), Martin Borggrefe (Germany), John Camm (UK), Perry Mark Elliott (UK).
Abstract: 2015 ESC Guidelines for the Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death

942 citations


Journal ArticleDOI
TL;DR: In the largest series of Brugada syndrome patients thus far, event rates in asymptomatic patients were low and gender, familial history of SCD, inducibility of ventricular tachyarrhythmias during electrophysiological study, and the presence of an SCN5A mutation were not predictive of arrhythmic events.
Abstract: BACKGROUND: Brugada syndrome is characterized by ST-segment elevation in the right precordial leads and an increased risk of sudden cardiac death (SCD). Fundamental questions remain on the best strategy for assessing the real disease-associated arrhythmic risk, especially in asymptomatic patients. The aim of the present study was to evaluate the prognosis and risk factors of SCD in Brugada syndrome patients in the FINGER (France, Italy, Netherlands, Germany) Brugada syndrome registry. METHODS AND RESULTS: Patients were recruited in 11 tertiary centers in 4 European countries. Inclusion criteria consisted of a type 1 ECG present either at baseline or after drug challenge, after exclusion of diseases that mimic Brugada syndrome. The registry included 1029 consecutive individuals (745 men; 72%) with a median age of 45 (35 to 55) years. Diagnosis was based on (1) aborted SCD (6%); (2) syncope, otherwise unexplained (30%); and (3) asymptomatic patients (64%). During a median follow-up of 31.9 (14 to 54.4) months, 51 cardiac events (5%) occurred (44 patients experienced appropriate implantable cardioverter-defibrillator shocks, and 7 died suddenly). The cardiac event rate per year was 7.7% in patients with aborted SCD, 1.9% in patients with syncope, and 0.5% in asymptomatic patients. Symptoms and spontaneous type 1 ECG were predictors of arrhythmic events, whereas gender, familial history of SCD, inducibility of ventricular tachyarrhythmias during electrophysiological study, and the presence of an SCN5A mutation were not predictive of arrhythmic events. CONCLUSIONS: In the largest series of Brugada syndrome patients thus far, event rates in asymptomatic patients were low. Inducibility of ventricular tachyarrhythmia and family history of SCD were not predictors of cardiac events.

678 citations


Journal ArticleDOI
TL;DR: Optimal implantable cardioverter-defibrillator programming and follow-up dramatically reduce inappropriate shock in patients with Brugada syndrome, but lead failure remains a major problem in this population.
Abstract: Background— Implantable cardioverter-defibrillator indications in Brugada syndrome remain controversial, especially in asymptomatic patients. Previous outcome data are limited by relatively small numbers of patients or short follow-up durations. We report the outcome of patients with Brugada syndrome implanted with an implantable cardioverter-defibrillator in a large multicenter registry. Methods and Results— A total of 378 patients (310 male; age, 46±13 years) with a type 1 Brugada ECG pattern implanted with an implantable cardioverter-defibrillator (31 for aborted sudden cardiac arrest, 181 for syncope, and 166 asymptomatic) were included. Fifteen patients (4%) were lost to follow-up. During a mean follow-up of 77±42 months, 7 patients (2%) died (1 as a result of an inappropriate shock), and 46 patients (12%) had appropriate device therapy (5±5 shocks per patient). Appropriate device therapy rates at 10 years were 48% for patients whose implantable cardioverter-defibrillator indication was aborted sudden cardiac arrest, 19% for those whose indication was syncope, and 12% for the patients who were asymptomatic at implantation. At 10 years, rates of inappropriate shock and lead failure were 37% and 29%, respectively. Inappropriate shock occurred in 91 patients (24%; 4±4 shocks per patient) because of lead failure (n=38), supraventricular tachycardia (n=20), T-wave oversensing (n=14), or sinus tachycardia (n=12). Importantly, introduction of remote monitoring, programming a high single ventricular fibrillation zone (>210–220 bpm), and a long detection time were associated with a reduced risk of inappropriate shock. Conclusions— Appropriate therapies are more prevalent in symptomatic Brugada syndrome patients but are not insignificant in asymptomatic patients (1%/y). Optimal implantable cardioverter-defibrillator programming and follow-up dramatically reduce inappropriate shock. However, lead failure remains a major problem in this population. # Clinical Perspective {#article-title-24}

404 citations


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Frequently Asked Questions (1)
Q1. What have the authors contributed in "Time-to-first appropriate shock in patients implanted prophylactically with an implantable cardioverter defibrillator: data from the survey on arrhythmic events in brugada syndrome (sabrus)" ?

In this paper, the authors used multivariate logistic regression models to identify which parameters predicted time to arrhythmia ≤ 5 years.