P2279First clinical evaluation of subcutaneous implantable cardiac defibrillator in Brugada patients

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Probst ◽  
G Clerici ◽  
D Babuty ◽  
N Badenco ◽  
C Marquie ◽  
...  

Abstract Background Brugada syndrome (BrS) is an inherited arrhythmia syndrome with an increased risk of SCD. While Subcutaneous ICD (S-ICD) is a seductive approach to treat these patients, questions raised on the risk of inappropriate shock in this specific population. Objective The aim of this study was to evaluate the safety and the effectiveness of the S-ICD in BrS patients. Methods We prospectively enrolled 112 BrS patients implanted with S-ICD in 17 European centers. During the screening at least 2 vectors must be suitable but it was not necessary to check for the suitability of the ECG during sodium channel blocker or exercise test. S-ICD indications follow the current guidelines. Results Mean age of patients was 45±13 years, with 95 (85%) males. Implantation was performed in 91 (83%) patients for primary prevention and in 18 (16%) patients for secondary prevention. There is an indication of ICD replacement for 16 patients (14%): 13 lead defect (81%), 1 infection (6%) and 2 ICD end of life (13%). In this cohort, 57 patients (51%) had spontaneous type I BrS, 60 patients (55%) were symptomatic: 10 resuscitated SCD (17%) and 48 (83%) syncope. Implantation was performed under general anesthesia in 79 patients (71%). The mean operation time was 56±19 min. The lead was placed at the left side of the sternum in 102 patients (92%) and at the right side in 9 (8%). Sensing configuration was the primary vector for 46 patients (41%), secondary vector for 57 (51%) and alternative vector for 9 (8%). No complications occurred during implantation. During a mean follow-up of 15.6 months (0–39 months), 6 patients (5%) had at least one appropriate shock (n=9). The rate of appropriate shock was 4.5%/y. All the VF episodes were successfully treated with the first shock. One patient had VF ablation for recurrent VF. Among the 6 patients who received an appropriate shock, 3 (50%) were implanted for secondary prevention and 3 (50%) were implanted for primary prevention including 2 patients with a history of syncope and one asymptomatic patient. Twelve patients (11%) had at least one inappropriate shock (n=22) including 2 patients with respectively 8 and 4 inappropriate shocks due to T-wave oversensing. With the SMART pass system the first patient had no more inappropriate shock for now 2 years. The rate of inappropriate shock was 9%/y. One patient died of myocardial infarction. Five patients (4%) were hospitalized for complications (4 pocket or scar infections and 1 electrode failure). Conclusion Our initial experience showed that S-ICD is efficient to treat VF episode in BrS patients. In this population, the rate of inappropriate shock was 9%/y. In view of these results, S-ICD implantation seems to be efficient to protect BrS patients against SCD. Acknowledgement/Funding Investigator-Sponsored Research program, Boston Scientific

Heart ◽  
2018 ◽  
Vol 104 (18) ◽  
pp. 1529-1535 ◽  
Author(s):  
Sérgio Barra ◽  
Rui Providência ◽  
Serge Boveda ◽  
Rudolf Duehmke ◽  
Kumar Narayanan ◽  
...  

ObjectiveIn patients indicated for cardiac resynchronisation therapy (CRT), the choice between a CRT-pacemaker (CRT-P) versus defibrillator (CRT-D) remains controversial and indications in this setting have not been well delineated. Apart from inappropriate therapies, which are inherent to the presence of a defibrillator, whether adding defibrillator to CRT in the primary prevention setting impacts risk of other acute and late device-related complications has not been well studied and may bear relevance for device selection.MethodsObservational multicentre European cohort study of 3008 consecutive patients with ischaemic or non-ischaemic dilated cardiomyopathy and no history of sustained ventricular arrhythmias, undergoing CRT implantation with (CRT-D, n=1785) or without (CRT-P, n=1223) defibrillator. Using propensity score and competing risk analyses, we assessed the risk of significant device-related complications requiring surgical reintervention. Inappropriate shocks were not considered except those due to lead malfunction requiring lead revision.ResultsAcute complications occurred in 148 patients (4.9%), without significant difference between groups, even after considering potential confounders (OR=1.20, 95% CI 0.72 to 2.00, p=0.47). During a mean follow-up of 41.4±29 months, late complications occurred in 475 patients, giving an annual incidence rate of 26 (95% CI 9 to 43) and 15 (95% CI 6 to 24) per 1000 patient-years in CRT-D and CRT-P patients, respectively. CRT-D was independently associated with increased occurrence of late complications (HR=1.68, 95% CI 1.27 to 2.23, p=0.001). In particular, when compared with CRT-P, CRT-D was associated with an increased risk of device-related infection (HR 2.10, 95% CI 1.18 to 3.45, p=0.004). Acute complications did not predict overall late complications, but predicted device-related infection (HR 2.85, 95% CI 1.71 to 4.56, p<0.001).ConclusionsCompared with CRT-P, CRT-D is associated with a similar risk of periprocedural complications but increased risk of long-term complications, mainly infection. This needs to be considered in the decision of implanting CRT with or without a defibrillator.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Tara Bharucha ◽  
Andrew M Davis ◽  
Christian Turner ◽  
Robert Justo ◽  
Terry Robertson ◽  
...  

Introduction Better data regarding the incidence and risk factors for sudden cardiac death (SCD) in children with cardiomyopathy (CM) is critical in defining appropriate primary prevention strategies. Methods The National Australian Childhood Cardiomyopathy Study is a prospective cohort study, including all children in Australia with primary CM diagnosed at 0 – 10 years of age, between 1987–1997. SCD was defined as sudden and unexpected death in children who were not hospitalized and not in congestive heart failure at the time of death. Nine subjects with sudden death as presenting symptom were excluded. Indexed echocardiographic measurements at latest follow-up were compared between subjects with SCD and survivors. Results Study criteria were met by 291 children. Mean duration of follow-up was 9.2 years. The incidence of sudden death relative to each CM type, for all cases and as a proportion of deaths, is shown in the Table : Incidence of SCD by CM type. SCD incidence was significantly associated with CM type, for all cases ( p = 0.006) and when only those subjects who died were considered ( p = 0.005), with LVNC and RCM having up to 4 times the risk of other CM types. Children with familial DCM had a significantly higher rate of SCD than subjects with non-familial CM (12% vs 3%; p = 0.028), however, familial CM was not a risk factor in other CM types. DCM SCD subjects had larger LVEDd Z score than survivors (median 5.53 vs 1.16; p <0.0001) and lower FS Z score (median −9.23 vs −0.51; p = 0.0025). HCM SCD subjects had thicker LVPW dimension Z scores than survivors (median 4.63 vs 1.18; p = 0.007). Twelve subjects (2 DCM, 8 HCM and 2 LVNC) underwent ICD implantation (8/12 for primary prevention). Conclusions: This population based study defines new risk factors for sudden death in children with CM. RCM is well known to have a high incidence of SCD. In addition, children with LVNC and those with DCM who have severe dilatation, systolic dysfunction or familial DCM are at increased risk of sudden death.


2020 ◽  
Vol 35 (12) ◽  
pp. 556-565
Author(s):  
Taylor Naberhaus ◽  
Nicole K. Early ◽  
Kathleen A. Fairman ◽  
Kelsey Buckley

OBJECTIVE: This study assesses the rate of providerrecommended aspirin use through the National Ambulatory Medical Care Survey (NAMCS) database versus self-reported aspirin use through the Behavioral Risk Factor Surveillance System (BRFSS) database and identifies factors that predict initiation of aspirin. This study provides insight into the rate of providerrecommended aspirin use versus self-reported aspirin use prior to the 2016 United States Preventive Service Task Force primary prevention recommendation update.<br/> DESIGN: Retrospective, cross-sectional analysis of US population data obtained from medical records (NAMCS) and community-dwelling residents in four states (BRFSS) in 2015.<br/> SETTING: Physician offices (NAMCS) and households or telephone (BRFSS).<br/> PATIENTS, PARTICIPANTS: NAMCS: visits made by patients 40 years of age or older to physicians who permitted federal employees to abstract officevisit data. BRFSS: household or telephone interview respondents 40 years of age or older.<br/> INTERVENTIONS: Comparisons of persons with (secondary prevention) versus without (primary prevention) cardiovascular disease.<br/> MAIN OUTCOME MEASURED: Recommended (NAMCS) or self-reported (BRFSS) use of aspirin.<br/> RESULTS: The sample included 19 170 patients (NAMCS), with 2 205 having a history of cardiovascular disease and 14 872 respondents (BRFSS) with 2 024 having a history of cardiovascular disease. For both primary and secondary prevention, respondents from BRFSS reported higher rates of aspirin use (27.7% primary, 65.6% secondary prevention) compared with prescribed rates from NAMCS (11.7% primary, 45.6% secondary prevention).<br/> CONCLUSIONS: Study results highlight the value of obtaining a complete medication history, including aspirin use, from all patients.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Amalie C Thavikulwat ◽  
Todd T Tomson ◽  
Bradley P Knight ◽  
Robert O Bonow ◽  
Lubna Choudhury

Introduction: Hypertrophic cardiomyopathy (HCM) is a leading cause of sudden cardiac death (SCD) in young adults. Implantable cardioverter defibrillators (ICD) effectively terminate ventricular tachycardia (VT) and fibrillation (VF) that cause SCD, but the reported prevalence of and patient characteristics leading to appropriate ICD therapy in HCM have been variable. Hypothesis: We hypothesized that some risk factors may be more prevalent than others in patients with HCM who receive appropriate ICD therapy and that the overall incidence of appropriate therapy may be lower than that reported previously. Methods: We retrospectively studied all patients with HCM who were treated with ICDs at our referral center from 2000-2013 to determine the rates of appropriate and inappropriate ICD therapies. Results: Of 1136 patients with HCM, we identified 135 who underwent ICD implantation (125 for primary and 10 for secondary prevention), aged 18-81 years (mean 48±17) at the time of implantation. The mean follow-up time was 5.2±4.5 years. Appropriate ICD intervention occurred in 20 of 135 patients (2.8%/year) by providing a shock or antitachycardia pacing in response to VT or VF. The annual rate of appropriate ICD therapy was 2.4%/year for primary and 7.2%/year for secondary prevention devices. Commonly used risk factors were equally prevalent among patients who received appropriate therapy and those who did not; furthermore, the likelihood of receiving appropriate therapy in the presence of each risk factor was similar (Figure). Inappropriate ICD therapy occurred in 27 patients (3.8%/year). Conclusions: ICDs provide clear benefit to patients who experience life-threatening arrhythmias, particularly those being treated for secondary prevention. However, the appropriate therapy rate for primary prevention was lower than previously reported, and no single risk factor appeared to have stronger association with appropriate ICD therapy than others.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Mejalli AlKofahi ◽  
Moghniuddin Mohammed ◽  
Madhu Reddy ◽  
Raghuveer Dendi ◽  
Rhea C Pimentel ◽  
...  

Introduction: Subcutaneous ICD (S-ICD) implantation is a viable alternative to transvenous ICD implantation in patients without a pacing indication. The S-ICD lead is placed near the sternum. The safety of S-ICD implantation and risk for inappropriate shocks is uncertain in patients with prior sternotomy. Methods: This single-center retrospective cohort study included patients that had implantation of an S-ICD between February 2014 - May 2020. The 30-day complication rates and long-term risks of inappropriate shocks were compared between patients with and without prior sternotomy. Results: Ninety-eight patients (52 ± 15 years old, 43% men, BMI 29 ± 6, 72% primary prevention, 28% ischemic cardiomyopathy, median LVEF 30% (IQR 25-45%)) underwent S-ICD implantation, among whom 19 (19.4%) had a prior sternotomy. The median time between sternotomy and S-ICD implantation was 96 (IQR 4.1-306) months. The sternal coil was primarily implanted left of the sternum (n=17/19, 89%). A two-incision technique was used in 79% of patients with prior sternotomy vs. 65% without sternotomy (p=0.23). The 30-day complication rate was similar between those with and without prior sternotomy (n=1/19 vs. n=10/79, 5% vs. 13%, p=0.36). The only 30-day complication in patients with prior sternotomy was a hematoma without intervention. The 30-day complications in patients without prior sternotomy included: superficial site infection resolving with brief antibiotics (n=4), inappropriate shock (n=3), lead migration requiring revision (n=2), and a hematoma without intervention (n=1). Over a median follow-up of 17.1 (IQR 3.4-29.1) months, the frequency of inappropriate shocks was similar between patients with and without prior sternotomy (n=1/19 and n=6/79, 5% vs. 8%, p=0.72). The median time to inappropriate shock from S-ICD implantation was 1.1 (IQR 0.1-19.8) months. The mechanisms of inappropriate shocks were T-wave oversensing or other oversensing (n=5/7, 72%), air in the pocket (n=1/7, 14%), and atrial tachycardia (n=1/7, 14%). Conclusions: Implantation of S-ICD in patients with prior sternotomy was not associated with an increased risk of 30-day complications or inappropriate shocks. These outcomes need to be confirmed in larger, multicenter studies.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Bjerre ◽  
S M Rosenkranz ◽  
M Schou ◽  
C Jons ◽  
B T Philbert ◽  
...  

Abstract Background Patients with an implantable cardioverter defibrillator (ICD) are restricted from driving following initial implantation or ICD shock. It is unclear how many patients are aware of, and adhere to, these restrictions. Purpose To investigate knowledge of, and adherence to, private and professional driving restrictions in a nationwide cohort of ICD patients. Methods A questionnaire was distributed to all living Danish residents ≥18 years who received a first-time ICD between 2013 and 2016 (n=3,913). During this period, Danish guidelines recommended 1 week driving restriction following ICD implantation for primary prevention, and 3 months following either ICD implantation for secondary prevention or appropriate ICD shock, and permanent restriction of professional driving and driving of large vehicles (>3.5 metric tons). Questionnaires were linked with relevant nationwide registries. Logistic regression was applied to identify factors associated with non-adherence. Results Of 2,741 questionnaire respondents, 92% (n=2,513) held a valid private driver's license at time of ICD implantation (85% male; 46% primary prevention indication; median age: 67 years (IQR: 59–73)). Of these, 7% (n=175) were actively using a professional driver's license for truck driving (n=73), bus driving (n=45), taxi driving (n=22), large vehicle driving for private use (n=54), or other purposes (n=32) (multiple purposes allowed). Only 42% of primary prevention patients, 63% of secondary prevention patients, and 72% of patients who experienced an appropriate ICD shock, recalled being informed of any driving restrictions. Only 45% of professional drivers recalled being informed about specific professional driving restrictions (Figure). Most patients (93%, n=2,344) resumed private driving after ICD implantation, more than 30% during the driving restriction period: 34% of primary prevention patients resumed driving within 1 week, 43% of secondary prevention patients resumed driving within 3 months, and 30% of patients who experienced an appropriate ICD shock resumed driving within 3 months. Professional driving was resumed by 35%. Patients who resumed driving within the restricted periods were less likely to report having received information about driving restrictions (all p<0.001) (Figure). In a multiple logistic regression model, non-adherence was predicted by reporting non-receipt of information about driving restrictions (OR: 3.34, CI: 2.27–4.03), as well as male sex (OR: 1.53, CI: 1.17–2.01), age ≥60 years (OR: 1.20, CI: 1.02–1.64), receipt of a secondary prevention ICD (OR: 2.2, CI: 1.80–2.62), and being the only driver in the household (OR: 1.29, CI: 1.05–1.57). Conclusion In this nationwide survey study, many ICD patients were unaware of the driving restrictions, and many ICD patients, including professional drivers, resumed driving within the restricted periods. More focus on communicating driving restrictions might improve adherence. Acknowledgement/Funding Danish Heart Foundation, Arvid Nilsson Foundation, Fraenkels Mindefond


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Mielczarek ◽  
P Syska ◽  
M Lewandowski ◽  
A Przybylski ◽  
M Sterlinski ◽  
...  

Abstract Introduction According to the literature, the annual mortality rate of hypertrophic cardiomyopathy (HCM) patients is estimated to 1–2%. Sudden cardiac death (SCD), heart failure and thromboembolism are the main causes of death among this population. Patients at high risk for SCD, identified using HCM risk score, are qualified for ICD implantation. Unfortunately for clinicians, there is no validated model or statistical tool for assessment of the risk of mortality within the HCM patients with ICDs. Purpose The aim of this study was to determine the main risk factors of all- cause mortality in HCM patients with ICDs. Methods The long-term follow-up of group of 104 consecutive patients with HCM, who had the ICD implanted between 1996 and 2006 in tertiary reference clinical unit was performed. Twenty patients who died during observation were the subject of the current analysis. ICD was implanted for primary (n=16) and secondary (n=4) prevention of SCD within this subpopulation. Analysis were performed for mentioned below potential risk factors: age at the time of implantation, syncopes, family history of SCD, atrial fibrillation/supraventricular tachycardia, decreased left ventricular ejection fraction (LVEF), non-sustained ventricular tachycardia (nsVT), maximum left ventricular wall thickness, abnormal exercise blood pressure response, left ventricular outflow tract obstruction. Results The average time of survival since ICD implantation was 8,5±4,6 years. Decreased LVEF (Wald chi2 4,57; p=0,033), secondary prevention (Wald chi2 8,57; p=0,003), family history of SCD (Wald chi2 4,93; p=0,026) and episodes of nsVT (Wald chi2 3,49; p=0,062) are the clinical risk factors that significantly affect the time of survival. The probability of death, expressed as Hazard Ratio, was 27-fold higher in secondary prevention group (HR=27,18), almost 10-fold higher in patients with positive family history of SCD (HR=9,74) and 3,7-fold higher when nsVT was detected. The cause of death was established in 16/20 patients. In 15 cases, these were deaths from cardiovascular causes: end-stage heart failure (8), complications of heart transplantation or circulatory support (4), SCD (1) and other cardiovascular (2). Conclusion Secondary prevention, positive family history of SCD, nsVT and decreased LVEF seem to be the most significant risk factors associated with all- cause mortality in HCM patients with ICDs. Despite the ICD implantation, subpopulation studied had poor prognosis with high incidence of progression to end-stage heart failure. Further studies to create validated model for assessment of death risk in long-term observation of patients with HCM after ICD implantation are required.


2020 ◽  
Vol 41 (Supplement_1) ◽  
Author(s):  
F S Foo ◽  
M Lee ◽  
A J Kerr

Abstract Introduction The ANZACS-QI DEVICE registry is a national registry designed to collect data on all cardiac implantable electronic devices (CIED) implanted in New Zealand (NZ). This study aims to provide a contemporary analysis of the clinical characteristics and implant details of patients receiving implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT), including CRT-Pacemaker (CRT-P) and CRT-Defibrillator (CRT-D). Methods Complete datasets of ICD, CRT-D and CRT-P implants from the ANZACS-QI DEVICE registry from 1st January 2014 to 31st December 2017 were analysed.  Results A total of 1579 ICD implants were identified. Of the 1152 (73.0%) new implants, 565 (49.0%) were for primary prevention and 587 (51.0%) were for secondary prevention. The baseline demographics of both groups were similar, with a median age of 62 and predominantly male (79.2-81.4%), with European (63.7-66.8%) and Maori (21.1-24.8%) being the most common ethnicities. The mean BMI was 29.6-30.2 kg/m², with most patients (75.2-80.7%) being in sinus rhythm at the time of ICD implant. Compared to the secondary prevention group, the primary prevention group had more patients with a history of heart failure (80.4% vs 39.7%), worse heart failure symptoms (NYHA Class II-III 77.1% vs 47.3%), poorer left ventricular ejection fraction (LVEF) (mean 25.1% vs 30.3%) and the aetiology was more likely to be non-ischaemic (57.5% vs 44.2%). The mean QRS duration was longer (129.9ms vs 113.4ms), with a higher incidence of left bundle branch block (31.9% vs 16.0%) and a correspondingly higher rate of CRT-D implants (27.4% vs 8.3%).  In the 427 (27.0%) ICD replacements, over a mean duration of 6.27 years, 46.6% had delivered appropriate therapy (including 38.4% with appropriate ICD shocks) whilst 17.8% had delivered inappropriate therapy. Compared to primary prevention CRT-D (n = 155), patients receiving CRT-P (n = 175) were older (median age 74 vs 66) and more likely to be female (38.3% vs 19.4%). CRT-D patients had longer mean QRS duration (169.2ms vs 160.8ms) and poorer LVEF (mean 24.3% vs 28.7%). Conclusion This analysis provides contemporary data on ICD and CRT use in New Zealand. Primary prevention ICD patients were more likely to have a history of heart failure, worse heart failure symptoms, more prolonged QRS duration, left bundle branch block and poorer LV function compared to secondary prevention ICD. Compared to primary prevention CRT-D, patients receiving CRT-P were older and more likely to be female.


2020 ◽  
pp. 1-10
Author(s):  
Franz Hozer ◽  
Samuel Sarrazin ◽  
Charles Laidi ◽  
Pauline Favre ◽  
Melissa Pauling ◽  
...  

Abstract Background Lithium (Li) is the gold standard treatment for bipolar disorder (BD). However, its mechanisms of action remain unknown but include neurotrophic effects. We here investigated the influence of Li on cortical and local grey matter (GM) volumes in a large international sample of patients with BD and healthy controls (HC). Methods We analyzed high-resolution T1-weighted structural magnetic resonance imaging scans of 271 patients with BD type I (120 undergoing Li) and 316 HC. Cortical and local GM volumes were compared using voxel-wise approaches with voxel-based morphometry and SIENAX using FSL. We used multiple linear regression models to test the influence of Li on cortical and local GM volumes, taking into account potential confounding factors such as a history of alcohol misuse. Results Patients taking Li had greater cortical GM volume than patients without. Patients undergoing Li had greater regional GM volumes in the right middle frontal gyrus, the right anterior cingulate gyrus, and the left fusiform gyrus in comparison with patients not taking Li. Conclusions Our results in a large multicentric sample support the hypothesis that Li could exert neurotrophic and neuroprotective effects limiting pathological GM atrophy in key brain regions associated with BD.


2016 ◽  
Vol 12 (02) ◽  
pp. 78
Author(s):  
Sanjay Kalra ◽  

Two major trials, LEADER and SUSTAIN 6, published in 2016, reported the cardiovascular and microvascular benefits of liraglutide and semaglutide respectively. This communication describes the results of these trials, and analyses the subtle differences in their outcomes. While semaglutide significantly reduces the risk of non-fatal myocardial infarction (primary prevention), liraglutide reduces the risk of all-cause mortality and cardiovascular mortality (secondary prevention). Both drugs significantly improve renal outcomes, but semaglutide increased the risk of retinal events. The time taken to achieve benefit was much less (4-6 months) with semaglutide than with liraglutide (12–18 months). LEADER and SUSTAIN 6 have made 2016 a landmark year in the history of diabetes care. Their positive results will help promote better, comprehensive diabetes care, using minimal drugs (therapeutic parsimony), encourage use of rational combinations to improve outcomes, and stimulate exaptation of these drugs for non-glycemic purposes.


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