scholarly journals Inappropriate shock in Brugada syndrome: incidence and predictors in patients with a subcutaneous implantable cardiac defibrillator

Author(s):  
Gavino Casu ◽  
Etelvino Silva ◽  
Felipe Bisbal ◽  
Graziana Viola ◽  
Pierluigi Merella ◽  
...  

Abstract Background: Subcutaneous implantable cardioverter defibrillators (S-ICDs) avoid complications secondary to transvenous leads, but inappropriate shocks (ISs) are frequent. Furthermore, IS data from patients with Brugada syndrome (BrS) with an S-ICD are scarce. Objective: We aimed to establish the incidence, mechanisms, and predictors of S-ICD in this population. Methods: We analyzed the clinical and electrocardiographic characteristics, automated screening test data, device programming, and IS occurrence in adult patients with BrS with an S-ICD. Results: Thirty-nine patients were enrolled (69% male, mean age at diagnosis 46±13 years, mean age at implantation 48±13 years). During a mean follow-up of 26±21 months, 18% patients experienced IS. Patients with IS were younger at the time of diagnosis (36±8 versus 48±13 years, p=0.018) and S-ICD implantation (38±9 versus 50±23 years, p=0.019) and presented with spontaneous type 1 Brugada ECG pattern more frequently at diagnosis or during follow-up (71% versus 25%, p=0.018). During automated screening tests, patients with IS showed lower QRS voltage in the primary vector in the supine position (0.58±0.26 versus 1.10±0.35 mV, p=0.011) and lower defibrillator automated screening score (DASS) in the primary vector in the supine (123±165 versus 554±390 mV, p=0.005) and standing (162±179 versus 486±388 mV, p=0.038) positions. Age at diagnosis was the only independent predictor of IS (hazard ratio=0.873, 95% confidence interval: 0.767-0.992, p=0.037). Conclusion: IS was a frequent complication in patients with BrS with an S-ICD. Younger age was independently associated with IS. A more thorough screening process might help prevent IS in this population.

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Bodin ◽  
A Bisson ◽  
B Pierre ◽  
J Herbert ◽  
N Clementy ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Introduction / Background Subcutaneous implantable cardioverter–defibrillators (S-ICD) was designed to avoid complications of single-chamber transvenous implantable cardioverter-defibrillators (VVI ICD) by using an entirely extra-thoracic placement. Purpose Our objective was to compare outcomes following first VVI ICD or S-ICD implantation in an exhaustive nationwide matched cohort. Methods This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults (age ≥18 years) hospitalized in French hospitals From January 1, 2010 to September 1, 2020, who underwent a VVI ICD or S-ICD implantation were included. Patients with a previous pacemaker or ICD or with a history of infective endocarditis were excluded. Multivariable analyses for clinical outcomes during the whole follow-up in the groups of interests were performed using a Cox model with all baseline characteristics and reporting hazard ratio. Owing to the non-randomized nature of the study, and considering for significant differences in baseline characteristics, propensity-score matching was also used to control for potential confounders of the treatment outcome relationship. Results 21,667 patients were included in the cohort, 19,493 patients had a transvenous VVI ICD and 2,174 had a subcutaneous ICD. Mean age was 61.2 ± 13.2 years in the VVI ICD group and 52.3 ± 17.5 years in the S-ICD goup. Coronary artery disease was present in 71.6% of patients with a VVI ICD and 48.2% of patients with a S-ICD. Mean follow-up was 28.8 ± 31.8 months. S-ICD patients had a significant higher rate of all-cause death (HR: 1.684, 95%CI: 1.309-2.165, p < 0.001). There were no significant differences in cardiovascular death (HR: 1.092, 95%CI: 0.697-1.711, p = 0.70) and infective endocarditis (HR: 0.354, 95%CI: 0.067-1.433, p = 0.15) between the two groups Using propensity score, 1,582 patients with VVI ICD were matched 1:1 with S-ICD patients. Mean follow-up was 4.5 ± 7.2 months. In the matched analysis, there were no significant differences in all-cause death (HR: 1.090, 95%CI: 0.728-1.633, p = 0.68) and cardiovascular death (HR: 1.167, 95%CI: 0.603-2.260, p = 0.65) between the two groups. A trend toward a lower risk of infective endocarditis in the S-ICD group was also observed without reaching significance (HR : 0.219, 95%CI: 0.047-1.017, p = 0.053). A sensitivity analysis in patients with coronary artery disease in the matched cohort was performed. Same trends were observed without significant differences in all-cause death and cardiovascular death. Conclusion Our nationwide study highlighted a higher risk of all-cause death in patients treated with subcutaneous which however was not statistically significant after propensity score matching. No differences regarding cardiovascular mortality was found. An interesting trend toward diminution of infective endocarditis was also observed without reaching significancy.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
V Bianchi ◽  
I Diemberger ◽  
V Tavoletta ◽  
L Perrotta ◽  
L Ottaviano ◽  
...  

Abstract Funding Acknowledgements No funding OnBehalf RHYTHM DETECT Registry Background With subcutaneous implantable cardioverter–defibrillators (S-ICD), conversion test (CT) is still recommended at implantation. However, prior works found that adherence to this recommendation is declining in clinical practice. Purpose To describe current practice regarding CT at S-ICD implantation, and also measure in-hospital outcome of patients who underwent CT and mid-term outcome of patients without CT. Methods We analyzed 1652 consecutive patients (49 ± 15 years old, 80% male, 51% with ischemic or non-ischemic dilated cardiomyopathy, 45% with ejection fraction ≤35%) who underwent S-ICD implantation in 60 Italian centers from 2013 to 2019. Results CT data were missing in 27 patients. CT was performed in 1300 patients. Successful conversion with ≤65J was obtained in 97.4% of patients. Shock at 80J was not effective in 12 (0.9%) patients. In 10 of these patients the CT was successful after device repositioning, while in 2 patients it was decided to implant a transvenous ICD. Two (0.15%) episodes of electromechanical dissociation (1 fatal) were reported as consequence of CT. CT was not performed in 325 patients (for clinical reasons in 182 patients, for facility preference in 71, ventricular fibrillation not inducible in 72 patients). As compared to the CT group, these patients were older (51 ± 16 vs. 48 ± 15 years; p < 0.01) and had lower ejection fraction (37 ± 16% vs. 46 ± 16%; p < 0.01). 243 non-CT patients had at least 6 months follow-up (median 15 months). In this group, 12 (4.9%) patients had appropriate shocks to treat VT/VF (all successfully terminated with the first shock), and 9 (3.7%) patients had inappropriate shocks. Conclusions This analysis showed that CT is frequently omitted in current clinical practice, especially in older patients with worse systolic function. Shocks at CT are very frequently effective and system revision after CT is rarely required. CT is also safe, although serious adverse events cannot be excluded. A strategy that omits CT did not appear to compromise the effectiveness of the S-ICD, but larger populations and longer follow-up are needed to confirm this finding.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Mazzanti ◽  
S Marelli ◽  
T Chargeishvili ◽  
A Trancuccio ◽  
M Marino ◽  
...  

Abstract Background A conclusive estimate of the eligibility rate for the use of subcutaneous implantable cardioverter defibrillators (S-ICD) in patients with Brugada Syndrome (BrS) is lacking. Objective We aimed to: 1) evaluate the eligibility for S-ICD in patients with BrS using a novel automated tool; 2) investigate predictors of ineligibility for S-ICD, based on baseline 12-lead electrocardiogram. Methods Automated screening for S-ICD was performed in 118 consecutive BrS patients using the programmer provided by the S-ICD producer. The system automatically assessed the acceptability of each of the three sense vectors used by the S-ICD for the detection of cardiac rhythm. Eligibility was defined when at least one vector was acceptable both in supine and standing position. Results The clinical characteristics of 118 BrS patients were as follow: age 43±11 years; 89% males; 2% with aborted cardiac arrest; 14% with a history of syncope; 81% with spontaneous type 1 ECG pattern; 21% with a familial history of sudden cardiac death; 24% with an SCN5A mutation. No patients had an indication for pacing. Only 8/118 (7%) patients were ineligible for S-ICD. Of note, 5/8 (63%) patients who failed the screening exhibited a slurred S wave of ≥80 ms duration in the peripheral lead aVF on the 12-lead baseline electrocardiogram, vs. 4/110 (4%) of those who passed the screening (sensitivity of S wave in aVF for screening failure 63%, specificity 97%; p<0.001). Remarkably, the presence of a slurred S wave of ≥80 ms duration in lead aVF remained significantly associated to the failure of eligibility for S-ICD (odds ratio 50, p<0.001) in a multivariable analysis that included the previous history of symptoms, the presence of a spontaneous type 1 ECG pattern, the gender and the presence of SCN5A mutations. ECG predictor of S-ICD screening Conclusion Up to 93% of BrS patients are eligible for S-ICD when the automated screening tool is used. The presence of a slurred S wave in lead aVF on the 12-lead electrocardiogram is a powerful predictor of screening failure.


Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001622
Author(s):  
Laura Helena Ollila ◽  
Kjell Nikus ◽  
Hannu Parikka ◽  
Sini Weckström ◽  
Heliö Tiina

AimsLMNA-cardiomyopathy is often associated with pathology in the cardiac conduction system necessitating device implantations. The aim was to study the timing and types of device implantations and need for re-implantations in LMNA mutation carriers.MethodsWe studied the hospital records of 60 LMNA mutation carriers concerning device implantations and re-implantations and their indications. Data were collected until April 2019.ResultsThe median follow-up time from the first ECG recording to the last clinical follow-up, transplantation, or death was 7.7 (IQR=9.1) years. Altogether 61.7% (n=37) of the LMNA mutation carriers received a pacemaker or an implantable cardioverter defibrillator (ICD), and of them 27.0% (n=10) needed a device upgrade. Notably, in some patients the upgrade took place very soon after the first implantation. The first device was implanted at an average age of 47.9 years (SD=9.5), whereas the upgrade took place at an average age of 50.3 years (SD=8.1). Most upgrades were ICD implantations. Male patients underwent device upgrade more often and at a younger age than women. By the end of follow-up, 35.0% (n=21) of the patients fulfilled echocardiographic criteria for dilated cardiomyopathy, and 90.5% of them (n=19) needed pacemaker implantation.ConclusionMost LMNA mutation carriers underwent pacemaker implantation in this study. Due to the progressive nature of LMNA-cardiomyopathy, device upgrades are quite common. An ICD should be considered when the initial device implantation is planned in an LMNA mutation carrier.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
L Oliveira ◽  
D Cavaco ◽  
G Rodrigues ◽  
D Matos ◽  
MS Carvalho ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Previous studies have shown an adverse prognosis for patients with transvenous implantable cardioverter-defibrillators (ICD) who receive both appropriate and inappropriate shocks. There is a paucity of data regarding the prognosis of inappropriate shocks in patients with a subcutaneous ICD (S-ICD). Purpose To assess and characterize S-ICD appropriate (AS) and inappropriate shocks (IAS) and their impact on mortality. Methods Single center observational registry of 162 consecutive patients who underwent S-ICD implantation for primary and secondary prevention between November 2009 and September 2020. Only follow-up data of at least 6 months was analysed to identify predictors of both IAS and AS and their mortality impact. Results A total of 144 patients were included in the analysis. Mean age was 42.2 ± 16.6 years and 75% of the patients were male. One hundred and four patients (72.2%) implanted the S-ICD in primary prevention. The most common etiology was ischemic cardiomyopathy (22.9%) followed by hypertrophic cardiomyopathy (18.8%) and dilated idiopathic cardiomyopathy (14.6%). During a mean follow-up of 42.3 ± 29.9 months a total of 48 patients (33.3%) experienced at least one S-ICD shock. Twenty-nine (20.1%) patients received AS due to VT/VF and 31 patients (21.5%) received IAS. Eighteen (58.1%) of the IAS were due to oversensing/noise/discrimination errors and the remaining due to supraventricular tachycardia. Overall, patients with AS (HR 4.93, 95% CI 1.58-15.36, p = 0.006) and higher number of total AS (HR 1.10, 95% CI 1.00-1.20, p = 0.044) were associated with higher mortality during follow-up. S-ICD IAS therapy did not affect overall mortality (HR 1.71, 95% CI 0.21-14.0, p = 0.616). Conclusions: In patients with S-ICD, those who receive AS, in contrast to IAS, seem to have a worse prognosis. Large scale studies are needed to confirm this hypothesis and to explain this findings. Abstract Figure. Survival curves for AS and IAS


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Scrocco ◽  
Y Ben-Haim ◽  
M Tome-Esteban ◽  
M Papadakis ◽  
S Sharma ◽  
...  

Abstract Background Experience with implantable loop recorder (ILR) in Brugada Syndrome (BrS) is limited. Purpose We sought to evaluate the usefulness of continuous monitoring in BrS patients in a UK based Inherited Cardiac Conditions centre. Methods Subjects with BrS were consecutively recruited and demographic, clinical, device and follow-up data acquired. Results Of 452 subjects with BrS recruited in our centre, 41 (9%) received an ILR. Twenty-one (51%) were males. Twenty-four subjects (59%) had a high probability of BrS based on the Shanghai score. Mean age at implantation was 45.3±15.5 years. The indications for the implantation were: syncope or pre-syncope in 28 subjects (68%), palpitations in 12 (29%), family history of SADS in 1 case. Sixteen subjects presented with a spontaneous type 1 pattern, of whom 12 (75%) underwent an electrophysiological study for risk stratification which was negative. During a mean follow-up of 82±46 months (range 4.0–182), 5 new diagnoses of atrial fibrillation (AF) or supraventricular tachycardia were made; 3 subjects had symptomatic pathological pauses (in one case associated with fast AF) and underwent permanent pacemaker or ICD implantation; one subject experienced an asymptomatic episode of fast, non-sustained monomorphic ventricular tachycardia. In 2 cases the device was explanted prematurely due to site infection. Patients who received an ECG diagnosis following interrogation of the ILR were older (mean age 55±11 vs 43±16m p=0.04), although there were no differences in sex or Shanghai score. Conclusions In a large UK cohort of BrS patients, the use of ILR was low. However, continuous subcutaneous monitoring yielded a diagnosis of tachy- or brady-arrhythmic episodes in 22% of cases, and therefore can be helpful in guiding the management of low/intermediate risk BrS patients. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Robert Lancaster Memorial Fund


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Jonas S De Jong ◽  
Roos F Marsman ◽  
José P Henriques ◽  
Arthur A Wilde ◽  
Lukas R Dekker

Introduction : Based on data from the thrombolysis era high mortality rates are ascribed to survivors of primary ventricular fibrillation, i.e. VF within the first 48 hours of acute myocardial infarction (AMI). However, current guidelines do not advice ICD implantation if left ventricular function recovers well. We present new data from a large dataset of primary VF survivors treated with percutaneous coronary intervention (PCI). Methods : Multi-center case-control study with prospective follow-up. Consecutive patients with a first AMI and VF prior to PCI (cases, n =372) were compared with patients with a first AMI without VF (controls, n =305). Primary endpoint is survival > 30 days. Results : Median follow up duration was 3.34 years for cases and 3.69 years for controls ( p = 0.015). VF occurred at a mean of 65 minutes after onset of chest pain and occurred out of hospital in 42.3%, in the ambulance in 23.4% and after hospital admission in 32.7% of cases. Median time to PCI was 160 mins in cases vs 180 mins in controls. All cause mortality > 30 days was 5.9% for cases and 8.2% for controls. Cox regression analysis showed that survival was not influenced by VF. During follow-up 25 cases received an ICD against 3 in controls. Even if all ICD wearers were presumed dead, VF did not reach significance as a predictor for survival. Significant predictors for improved survival were: younger age ( p =0.013) and time to PCI ( p =0.027). Conclusion : VF during AMI does not predict survival in those who survive the first month. These VF survivors have an excellent prognosis with or without an ICD. This study underlines that primary VF by itself does not constitute an indication for ICD implantation.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 37-38
Author(s):  
Shane Toolan ◽  
Mark Griffin ◽  
Mark Coyne ◽  
Kate O'Mahony ◽  
Joy Lewis ◽  
...  

Introduction The introduction of novel therapies has significantly improved outcomes in myeloma. However, the economic burden of enhanced healthcare utilization is significant and cannot be discounted. This study sought to identify baseline characteristics that may influence outcomes and subsequent healthcare utilization. Patients were also stratified by induction therapy to determine the impact newer combinations have on healthcare utilization. Methods This retrospective single-center study enrolled all newly diagnosed patients with myeloma between 2005 and 2020. Three outcome measures were used to determine healthcare utilization - total inpatient length of stay (LOS), number of admissions, and day ward attendances. Univariate and multivariable analyses were performed to identify significant covariates related to overall survival (OS) and healthcare utilization. Outcomes were subsequently adjusted for duration of follow-up and per patient year. Results There were 113 patients included; 60 (53.1%) female; median age at diagnosis was 67 years (IQR 62, 73 years) and 22.1% were high risk International Staging System (ISS). Further baseline demographics are presented in Table 1. Median duration of follow up was 3.2 years (IQR 1.50, 6.55). Sixty patients (53.1%) died, 91.7% attributable to myeloma or its treatment. Predictors of OS by multivariable analysis were advanced stage [ISS III (p&lt;0.001)] and IgA idiotype [(IgA vs IgG) (p=0.0002)]. Stem cell transplant eligibility was associated with improved OS (p=0.003). The total number of admissions to hospital was 547 (median 4; IQR 2, 7), with 55.4% unplanned. In the multivariable analysis, younger age (p=0.020), higher paraprotein levels (p=0.045), dialysis (p=0.037), and SCT eligibility (p=0.0012) were predictive of greater number of admissions. During the study period, there were 7000 inpatient bed occupancy days (median 46; IQR 26, 80). Only younger age remained significant (p=0.0028) in the multivariable analysis. There were a total of 5987 day care attendances during the study period. Multivariable analysis identified younger age at diagnosis (p&lt;0.0001), WBC (p=0.0072), and light chain (kLC vs lLC) (p=0.0027) as predictive of increased day ward attendance. Healthcare utilization correlated with increased survival, as depicted in figure 1. There was no significant relationship between treatment type and LOS (p=0.055); this remained unchanged when adjusted per patient year (p=0.24). There was significant relationship between treatment type and total number of admissions (p=0.015). Patients receiving anthracycline based therapy (p=0.003), Immunomodulatory (IMiD)/Proteasomal Inhibition (PI)/Steroid (p=0.020), or PI/Steroid (p=0.021) were more likely to have a greater number of admissions. However, when adjusted per patient year, this association was no longer evident (p=0.19). A highly significant relationship between treatment type and day ward attendances was identified (p&lt;0.0001). Alkylator based (pp=0.005), alkylator/PI/Steroid (p=0.006), anthracycline based (p=0.0002), IMiD/PI/Steroid (p=0.0007), or PI/Steroid (0.0002) were more likely to have greater day ward attendance. When adjusted per patient year, this significant association between treatment type and day ward attendance remained (p=0.0002). Conclusion Studies assessing healthcare utilization in patients with myeloma are mostly limited to relapsed refractory setting. In this population, younger age at presentation was a significant predictor for all three measures of healthcare utility. Whilst treatment type did not demonstrate a significant impact of LOS, we did determine that novel triplet therapy combinations were associated with increased number of admissions and day care attendances. We also showed that healthcare utilization increased with survival time. While survival outcomes with novel agents have improved, given current financial and capacity limitations within which the majority of health systems function, resource demand implications must be considered when planning future service provision and novel treatment strategies. Disclosures No relevant conflicts of interest to declare.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
V Bianchi ◽  
G Bisignani ◽  
V Russo ◽  
F Migliore ◽  
G Tola ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Defibrillation efficacy testing (DT) is recommended at implantation of subcutaneous implantable cardioverter–defibrillators (S-ICD). However, prior works found that adherence to this recommendation is declining in clinical practice. Purpose To compare survival from all-cause death and first ineffective shock (primary endpoint) and the composite of all-cause death, ineffective shock, inappropriate shock and device-related complication (secondary endpoint) between patients who underwent DT and those with omitted DT. Methods We analyzed 1652 consecutive patients who underwent S-ICD implantation in 60 Italian centers from 2013 to 2019. Results DT was not performed in 325 (20%) patients (no-DT patients). As compared with the DT group, these patients were older (51 ± 16 vs. 48 ± 15 years; p &lt; 0.01) and had lower ejection fraction (37 ± 16% vs. 46 ± 16%; p &lt; 0.01). The 325 no-DT patients were propensity matched with 325 patients of the DT group. During a median follow up of 19 months, 27 (4.2%) patients died for any-cause. During follow-up, 34 (5.2%) patients received appropriate shocks to treat discrete episodes of VT/VF. The first shock was effective in 30 out of 34 patients (88%), whereas a second shock was required to terminate VT/VF in 3 patients and a third shock in the last one. The primary endpoint occurred in 31 (4.8%) patients, and the risk was not significantly increased in the no-DT cohort (HR = 1.26, 95%CI:0.62-2.55, p = 0.522). Inappropriate shocks were reported in 36 (5.5%) patients and device-related complications in 25 (3.8%) patients during follow-up. Survival from the composite secondary endpoint was comparable between groups (HR = 0.86, 95%CI:0.57-1.32, p = 0.500). Conclusions Our data confirmed that DT is frequently omitted in current clinical practice, especially in older patients with worse systolic function. A strategy that omits DT did not appear to compromise the effectiveness of the S-ICD and no additional risk seems associated with DT omission at a mid-term follow-up. These data suggest that routine DT at S-ICD implant might not be necessary. Randomized trials are needed to confirm this finding.


Author(s):  
Rajesh Chelliah ◽  
Raj Khiani

This chapter covers implantable cardioverter defibrillators (ICD) implantation. Pre-procedure considerations such as the operative conditions, counselling, and consent are covered. Patient preparation and the necessary equipment and staff are defined. The implantation procedure is discussed in detail. Device testing and pacing parameters are covered, and methods for defibrillation threshold testing are explained. Problems that cause difficult testing are described, with potential solutions. Post-procedure management is explained, including follow-up and discharge instructions.


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