scholarly journals Long‐Term Outcomes Among a Nationwide Cohort of Patients Using an Implantable Cardioverter‐Defibrillator: UMBRELLA Study Final Results

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Sem Briongos‐Figuero ◽  
Arcadio García‐Alberola ◽  
Jerónimo Rubio ◽  
José María Segura ◽  
Aníbal Rodríguez ◽  
...  
Keyword(s):  
Heart Disease ◽  
Dilated Cardiomyopathy ◽  
Implantable Cardioverter Defibrillator ◽  
Valvular Heart Disease ◽  
Lower Risk ◽  
Ischemic Cardiomyopathy ◽  
High Rate ◽  
Icd Therapy ◽  
Cardioverter Defibrillator

Background Large‐scale studies describing modern populations using an implantable cardioverter‐defibrillator (ICD) are lacking. We aimed to analyze the incidence of arrhythmia, device interventions, and mortality in a broad spectrum of real‐world ICD patients with different heart disorders. Methods and Results The UMBRELLA study is a prospective, multicenter, nationwide study of contemporary patients using an ICD followed up by remote monitoring, with a blinded review of arrhythmic episodes. From November 2005 to November 2017, 4296 patients were followed up. After 46.6±27.3 months, 16 067 episodes of sustained ventricular arrhythmia occurred in 1344 patients (31.3%). Appropriate ICD therapy occurred in 27.3% of study population. Patients with ischemic cardiomyopathy (hazard ratio [HR], 1.51; 95% CI, 1.29–1.78), dilated cardiomyopathy (HR, 1.28; 95% CI, 1.07–1.53), and valvular heart disease (HR, 1.94; 95% CI, 1.43–2.62) exhibited a higher risk of appropriate ICD therapies, whereas patients with hypertrophic cardiomyopathy (HR, 0.72; 95% CI, 0.54–0.96) and Brugada syndrome (HR, 0.25; 95% CI, 0.14–0.45) showed a lower risk. All‐cause death was 13.4% at follow‐up. Ischemic cardiomyopathy (HR, 3.09; 95% CI, 2.58–5.90), dilated cardiomyopathy (HR, 3.33; 95% CI, 2.18–5.10), and valvular heart disease (HR, 3.97; 95% CI, 2.25–6.99) had the worst prognoses. Delayed high‐rate detection was enabled in 39.7% of patients, and single‐zone programming occurred in 52.6% of primary prevention patients. Both parameters correlated with lower risk of first appropriate ICD therapy, with no excess risk of mortality. The rate of inappropriate shocks at follow‐up was low (6%) and did not differ among type of ICD but was lower in SmartShock‐capable devices. Conclusions Irrespective of the cause, contemporary ICD patients with heart failure–related disorders had a similar risk of ICD life‐saving interventions and death. Current ICD programming recommendations still need to be implemented. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NTC01561144.

scholarly journals Long-term outcomes among a cohort of 4296 implantable cardioverter-defibrillator patients: insights from the UMBRELLA study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Briongos Figuero ◽  
A Garcia Alberola ◽  
J Rubio ◽  
J M Segura ◽  
A Rodriguez ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Heart Disease ◽  
Implantable Cardioverter Defibrillator ◽  
Remote Monitoring ◽  
Lower Risk ◽  
Left Ventricular ◽  
Icd Therapy ◽  
Cardioverter Defibrillator

Abstract Background Large observational real-world studies describing modern implantable cardioverter-defibrillator (ICD) populations with long-term follow-up are lacking. Purpose To assess the incidence of arrhythmias in a cohort of contemporary patients undergoing ICD implant from 2005 and 2017 and to analyze the arrhythmic risk and mortality according to their clinical profiles. Methods UMBRELLA (NTC01561144) is a prospective, multicentre, nationwide study of ICD patients followed by remote monitoring. All device information was automatically stored through the remote monitoring system and a blinded review of all the stored arrhythmic episodes was performed. The study outcomes were first appropriate ICD therapy and all-cause death. Results The study population consisted of 4296 patients (61.9±12.9 years, ischaemic cardiomyopathy (ICM): n=2150, dilated cardiomyopathy (DCM): n=1166, valvular heart disease (VHD): n=119, hypertrophic cardiomyopathy (HCM): n=294, arrhythmogenic right ventricular cardiomyopathy (ARVC): n=71, Brugada syndrome (BS): n=143, long QT syndrome (LQTS): n=43, and adult congenital heart disease (ACHD): n=60)). Primary prevention (PP) was the main indication (n=2758). During a mean follow-up of 46.6±27.3 months, 16,067 episodes of sustained ventricular arrhythmia (SVA) occurred in 1344 patients. Appropriate ICD therapy was delivered to 85.7% (n=13,767) episodes of SVA in 1173 patients (27.3% of population). A higher risk of first appropriate ICD therapy was observed in VHD (HR: 1.94, 95% CI: 1.43–2.62), ARVC (HR: 1.84, 95% CI: 1.28–2.66), ICM (HR: 1.51, 95% CI: 1.29–1.78), and DCM (HR: 1.28, 95% CI: 1.07–1.53) whereas patients with HCM (HR: 0.72, 95% CI: 0.54–0.96) and BS (HR: 0.25, 95% CI: 0.14–0.45) were at significantly lower risk (Figure 1A). In multivariate analysis (Table 1), age, gender, atrial fibrillation (AF), secondary prevention, LVEF ≤35%, and QRS width emerged as clinical predictors of appropriate ICD therapy, whereas CRT-D correlated with lower risk. An independently higher risk was found in DCM, VHD, and ARVC, and a lower risk in BS patients. At follow-up, 590 deaths (13.4% of population) were reported. Patients with ICM (HR 3.90, 95% CI: 2.58–5.90), DCM (HR 3.33, CI 95%: 2.18–5.10), and VHD (HR 3.97, CI 95%: 2.25–6.99) had worse prognoses and it was significantly better in BS patients (HR 0.11, 95% CI: 0.01–0.67, p=0.017) (Figure 1B). In multivariate analysis, age, gender, AF, renal failure, diabetes and reduced LVEF, emerged as independent predictors of all-cause death (Table 1). Conclusions Irrespective of the aetiology, contemporary ICD patients with an arrhythmic substrate derived from left ventricular systolic dysfunction had a similar risk of ICD life-saving interventions and death. FUNDunding Acknowledgement Type of funding sources: None. Table 1 Figure 1

Long-term follow-up of Chagas heart disease patients receiving an implantable cardioverter-defibrillator for secondary prevention

2018 ◽  
Vol 41 (6) ◽  
pp. 583-588 ◽  
Author(s):  
Maria Licia Ribeiro Cury Pavão ◽  
Elerson Arfelli ◽  
Adilson Scorzoni-Filho ◽  
Anis Rassi ◽  
Antônio Pazin-Filho ◽  
...  
Keyword(s):  
Heart Disease ◽  
Secondary Prevention ◽  
Implantable Cardioverter Defibrillator ◽  
Cardioverter Defibrillator ◽  
Long Term Follow Up ◽  
Chagas Heart Disease

scholarly journals Usefulness of the MAGGIC Score in Predicting the Competing Risk of Non-Sudden Death in Heart Failure Patients Receiving an Implantable Cardioverter-Defibrillator: A Sub-Analysis of the OBSERVO-ICD Registry

2021 ◽  
Vol 11 (1) ◽  
pp. 121
Author(s):  
Marco Canepa ◽  
Pietro Palmisano ◽  
Gabriele Dell’Era ◽  
Matteo Ziacchi ◽  
Ernesto Ammendola ◽  
...  
Keyword(s):  
Heart Failure ◽  
Sudden Death ◽  
Implantable Cardioverter Defibrillator ◽  
Competing Risk ◽  
Risk Scores ◽  
Icd Therapy ◽  
Cardioverter Defibrillator ◽  
Heart Failure Patients ◽  
Probability Of Death

The role of prognostic risk scores in predicting the competing risk of non-sudden death in heart failure patients with reduced ejection fraction (HFrEF) receiving an implantable cardioverter-defibrillator (ICD) is unclear. To this goal, we evaluated the accuracy and usefulness of the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score. The present analysis included 1089 HFrEF ICD recipients enrolled in the OBSERVO-ICD registry (NCT02735811). During a median follow-up of 36 months (1st–3rd IQR 25–48 months), 193 patients (17.7%) experienced at least one appropriate ICD therapy, and 133 patients died (12.2%) without experiencing any ICD therapy. The frequency of patients receiving ICD therapies was stable around 17–19% across increasing tertiles of 3-year MAGGIC probability of death, whereas non-sudden mortality increased (6.4% to 9.8% to 20.8%, p < 0.0001). Accuracy of MAGGIC score was 0.60 (95% CI, 0.56–0.64) for the overall outcome, 0.53 (95% CI, 0.49–0.57) for ICD therapies and 0.65 (95% CI, 0.60–0.70) for non-sudden death. In patients with higher 3-year MAGGIC probability of death, the increase in the competing risk of non-sudden death during follow-up was greater than that of receiving an appropriate ICD therapy. Results were unaffected when analysis was limited to ICD shocks only. The MAGGIC risk score proved accurate and useful in predicting the competing risk of non-sudden death in HFrEF ICD recipients. Estimation of mortality risk should be taken into greater consideration at the time of ICD implantation.

Long‐term follow‐up of adult patients with congenital heart disease and an implantable cardioverter defibrillator

2019 ◽  
Vol 14 (4) ◽  
pp. 525-533 ◽  
Author(s):  
Madalena Coutinho Cruz ◽  
André Viveiros Monteiro ◽  
Guilherme Portugal ◽  
Sérgio Laranjo ◽  
Ana Lousinha ◽  
...  
Keyword(s):  
Congenital Heart Disease ◽  
Heart Disease ◽  
Implantable Cardioverter Defibrillator ◽  
Congenital Heart ◽  
Adult Patients ◽  
Cardioverter Defibrillator ◽  
Long Term Follow Up

scholarly journals The Effect of Sacubitril/Valsartan on Device Detected Arrhythmias and Electrical Parameters among Dilated Cardiomyopathy Patients with Reduced Ejection Fraction and Implantable Cardioverter Defibrillator

2020 ◽  
Vol 9 (4) ◽  
pp. 1111 ◽  
Author(s):  
Vincenzo Russo ◽  
Roberta Bottino ◽  
Anna Rago ◽  
Andrea Antonio Papa ◽  
Biagio Liccardo ◽  
...  
Keyword(s):  
Ejection Fraction ◽  
Dilated Cardiomyopathy ◽  
Implantable Cardioverter Defibrillator ◽  
Reverse Remodeling ◽  
Electrical Parameters ◽  
Pacing Threshold ◽  
Reduced Ejection Fraction ◽  
Cardioverter Defibrillator ◽  
Echocardiographic Parameters

Sacubitril/valsartan therapy reduces sudden cardiac death (SCD) among patients with reduced ejection fraction (HFrEF) when compared to guidelines recommended doses of enalapril, however the mechanism is still not clear. There are few, contrasting results about the effect of sacubitril/valsartan on arrhythmias in the clinical context of dilated cardiomyopathy (DCM) and there are no clinical data about its effect on measured implantable cardioverter defibrillator (ICD) electrical parameters, such as atrial/ventricular electrograms sensing and pacing threshold. We conducted a 12 month follow-up observational study in 167 ischemic and nonischemic DCM patients (mean age 68.1 ± 11.6 years; 85% male), with dual-chamber ICD on sacubitril/valsartan treatment, to evaluate the incidence of device detected tachyarrhythmia events, both atrial and ventricular, and the change in measured ICD electrical parameters. We collected data on clinical, electrocardiographic and echocardiographic parameters to find a possible electro-mechanical correlation within results. Our results show that DCM patients with reduced ejection fraction and ICD on sacubitril/valsartan treatment experienced a reduction in both atrial and ventricular arrhythmias incidence and an improvement in ICD electrical atrial parameters. The findings might be explained by the electro-mechanical cardiac reverse remodeling induced by sacubitril/valsartan therapy.

scholarly journals Risk of subsequent ventricular arrhythmia is higher in primary prevention patients with implantable cardioverter defibrillator than in secondary prevention patients

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
You Zhou ◽  
Shuang Zhao ◽  
Keping Chen ◽  
Wei Hua ◽  
Yangang Su ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Ventricular Arrhythmia ◽  
Secondary Prevention ◽  
Implantable Cardioverter Defibrillator ◽  
Incidence Rate ◽  
Home Monitoring ◽  
Icd Therapy ◽  
Cardioverter Defibrillator ◽  
All Cause Mortality

Abstract Background Because of previous ventricular arrhythmia (VA) episodes, patients with implantable cardioverter-defibrillator (ICD) for secondary prevention (SP) are generally considered to have a higher burden of VAs than primary prevention (PP) patients. However, when PP patients experienced VA, the difference in the prognosis of these two patient groups was unknown. Methods The clinical characteristics and follow-up data of 835 ICD patients (364 SP patients and 471 PP patients) with home monitoring feature were retrospectively analysed. The incidence rate and risk of subsequent VA and all-cause mortality were compared between PP patients after the first appropriate ICD therapy and SP patients. Results During a mean follow-up of 44.72 ± 20.87 months, 210 (44.59%) PP patients underwent appropriate ICD therapy. In the Kaplan-Meier survival analysis, the PP patients after appropriate ICD therapy were more prone to VA recurrence and all-cause mortality than SP patients (P<0.001 for both endpoints). The rate of appropriate ICD therapy and all-cause mortality in PP patients after the first appropriate ICD therapy was significantly higher than that in SP patients (for device therapy, 59.46 vs 20.64 patients per 100 patient-years; incidence rate ratio [IRR] 2.880, 95% confidence interval [CI]: 2.305–3.599; P<0.001; for all-cause mortality, 14.08 vs 5.40 deaths per 100 patient-years; IRR 2.607, 95% CI: 1.884–3.606; P<0.001). After propensity score matching for baseline characteristics, the risk of VA recurrence in PP patients with appropriate ICD therapy was still higher than that in SP patients (41.80 vs 19.10 patients per 100 patient-years; IRR 2.491, 95% CI: 1.889–3.287; P<0.001), but all-cause mortality rates were similar between the two groups (12.61 vs 9.33 deaths per 100 patient-years; IRR 1.352, 95% CI: 0.927–1.972; P = 0.117). Conclusions Once PP patients undergo appropriate ICD therapy, they will be more prone to VA recurrence and death than SP patients.

Incidence and predictors of implantable cardioverter-defibrillator therapy and its complications in idiopathic ventricular fibrillation patients

EP Europace ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. 1519-1526
Author(s):  
Lennart J Blom ◽  
Marloes Visser ◽  
Imke Christiaans ◽  
Marcoen F Scholten ◽  
Marianne Bootsma ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Ventricular Fibrillation ◽  
Implantable Cardioverter Defibrillator ◽  
Recurrent Events ◽  
Risk Haplotype ◽  
Implantable Cardioverter Defibrillator Therapy ◽  
Idiopathic Ventricular Fibrillation ◽  
Icd Therapy ◽  
Cardioverter Defibrillator

Abstract Aims Idiopathic ventricular fibrillation (IVF) is a rare cause of sudden cardiac arrest. Implantable cardioverter-defibrillator (ICD) implantation is currently the only treatment option. Limited data are available on the prevalence and complications of ICD therapy in these patients. We sought to investigate ICD therapy and its complications in patients with IVF. Methods and results Patients were selected from a national registry of IVF patients. Patients in whom no underlying diagnosis was found during follow-up were eligible for inclusion. Recurrence of ventricular arrhythmia (VA) was derived from medical and ICD records, electrogram records of ICD therapies were used to differentiate between appropriate or inappropriate interventions. Independent predictors for appropriate ICD shock were calculated using cox regression. In 217 IVF patients, recurrence of sustained VAs occurred in 66 patients (30%) during a median follow-up period of 6.1 years. Ten patients died (4.6%). Thirty-eight patients (17.5%) experienced inappropriate ICD therapy, and 32 patients (14.7%) had device-related complications. Symptoms before cardiac arrest [hazard ratio (HR): 2.51, 95% confidence interval (CI): 1.48–4.24], signs of conduction disease (HR: 2.27, 95% CI: 1.15–4.47), and carrier of the DPP6 risk haplotype (HR: 3.24, 1.70–6.17) were identified as independent predictors of appropriate shock occurrence. Conclusion Implantable cardioverter-defibrillator therapy is an effective treatment in IVF, treating recurrences of potentially lethal VAs in approximately one-third of patients during long-term follow-up. However, device-related complications and inappropriate shocks were also frequent. We found significant predictors for appropriate ICD therapy. This may imply that these patients require additional management to prevent recurrent events.

Long-term follow-up of patients with tetralogy of Fallot and implantable cardioverter defibrillator

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Waldmann ◽  
A Bouzeman ◽  
G Duthoit ◽  
R Koutbi ◽  
F Bessiere ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Secondary Prevention ◽  
Heart Transplantation ◽  
Implantable Cardioverter Defibrillator ◽  
Tetralogy Of Fallot ◽  
Icd Therapy ◽  
Cardioverter Defibrillator ◽  
Long Term Follow Up

Abstract Background Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. Purpose We aimed to describe long-term follow-up of patients with TOF and ICD through a large nationwide registry. Methods Nationwide Registry including all TOF patients with an ICD initiated in 2010. The primary outcome was the first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. Cox proportional hazard models were used to identify predictors of appropriate ICD therapies and ICD-related complications. Results A total of 165 patients (mean age 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (IQR) follow-up of 6.8 (2.5–11.4) years, 78 (47.3%) patients received at least one appropriate ICD therapy, giving an annual incidence of 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively, p=0.03). Overall, 71 (43.0%) patients presented with at least one complication, including inappropriate ICD shocks in 42 (25.5%) patients and lead/generator dysfunction in 36 (21.8%) patients. Among 61 (37.0%) primary prevention patients, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with respectively no, one, two, or ≥ three guideline-recommended risk factors. In our cohort, QRS fragmentation was the only independent predictor of appropriate ICD therapies (HR 4.34, 95% CI 1.42–13.23), and its integration in a model with current criteria increased the area under the curve from 0.61 to 0.72 (p=0.006). No patient with left ventricular ejection fraction (LVEF) ≤35% without at least one other risk factor had appropriate ICD therapy. Patients with congestive heart failure and/or reduced LVEF had a higher risk of non-sudden death or heart transplantation (HR=11.01, 95% CI: 2.96–40.95). Conclusions Our findings demonstrate high rates of appropriate therapies in TOF patients with an ICD, including in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria might improve risk stratification beyond low LVEF. Freedom from appropriate ICD therapy Funding Acknowledgement Type of funding source: None

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