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 ◽  
...  

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

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Sem Briongos‐Figuero ◽  
Arcadio García‐Alberola ◽  
Jerónimo Rubio ◽  
José María Segura ◽  
Aníbal Rodríguez ◽  
...  

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.


2018 ◽  
Vol 41 (6) ◽  
pp. 583-588 ◽  
Author(s):  
Maria Licia Ribeiro Cury Pavão ◽  
Elerson Arfelli ◽  
Adilson Scorzoni-Filho ◽  
Anis Rassi ◽  
Antônio Pazin-Filho ◽  
...  

2019 ◽  
Vol 14 (4) ◽  
pp. 525-533 ◽  
Author(s):  
Madalena Coutinho Cruz ◽  
André Viveiros Monteiro ◽  
Guilherme Portugal ◽  
Sérgio Laranjo ◽  
Ana Lousinha ◽  
...  

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Waldmann ◽  
A Bouzeman ◽  
G Duthoit ◽  
R Koutbi ◽  
F Bessiere ◽  
...  

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


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Nicolas Lellouche ◽  
Carlos De Diego ◽  
Gina Akopyan ◽  
David A Cesario ◽  
Osamu Fujimura ◽  
...  

Background: Cardiac Resynchronization Therapy (CRT) is associated with reverse left ventricular (LV) remodeling. However, the effect of CRT on electrical remodeling, reverse mechanical remodeling, occurrence of ventricular arrhythmias is not well established. Methods: D ata from 45 patients who underwent implantable cardioverter defibrillator(ICD)-CRT implantation was retrospectively analyzed. Patients had New York Heart Association (NYHA) functional class III or IV heart failure symptoms, left ventricular ejection fraction (LVEF) <35%, and QRS duration >130 ms or QRS ≤130ms with left intraventricular dyssynchrony. Significant LV reverse remodeling was defined by a decrease of left ventricular end diastolic diameter (LVEDd) by at least 10% after 1 year of follow up. Electrocardiographic indices of dispersion of repolarization (DR) (QTc, T peak-Tend (Tp-e) and their dispersion) were measured immediately and 1 year after implantation. The occurrence of appropriate ICD therapy was noted for each patient. Results: Patients with significant LV reverse remodeling (n=21) and without LV reverse remodeling (n=24) had similar baseline characteristics. After one year of follow up, patients with LV reverse remodeling exhibited a significant decrease in DR parameters (Tp-e, QT dispersion and Tp-e dispersion), and lower rate of appropriate ICD therapy (log rank p=0.002), compared to those without reverse remodeling who experienced an increase in DR parameters (QT dispersion and Tp-e dispersion), figure 1 . Conclusion: Mechanical LV reverse remodeling is associated with an electrical reverse remodelling and a lower rate of appropriate ICD therapy. Figure 1: Occurence of appropriate CD therapy according to LV reverse remodelling


Circulation ◽  
2020 ◽  
Vol 142 (17) ◽  
pp. 1612-1622 ◽  
Author(s):  
Victor Waldmann ◽  
Abdeslam Bouzeman ◽  
Guillaume Duthoit ◽  
Linda Koutbi ◽  
Francis Bessiere ◽  
...  

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. Methods: A Nationwide French Registry including all patients with tetralogy of Fallot with an ICD was initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event end point was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. 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 (interquartile range) follow-up of 6.8 (2.5–11.4) years, 78 (47.3%) patients received at least 1 appropriate ICD therapy. The annual incidence of the primary outcome was 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 1 ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) patients in primary prevention, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with, respectively, 0, 1, 2, or ≥3 guidelines-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (hazard ratio, 3.47 [95% CI, 1.19–10.11]), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 ( P =0.006). Patients with congestive heart failure or reduced left ventricular ejection fraction had a higher risk of nonarrhythmic death or heart transplantation (hazard ratio, 11.01 [95% CI, 2.96–40.95]). Conclusions: Patients with tetralogy of Fallot and an ICD experience high rates of appropriate therapies, including those implanted 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 including QRS fragmentation might improve risk stratification. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03837574.


2012 ◽  
Vol 110 (7) ◽  
pp. 1040-1045 ◽  
Author(s):  
Martino Martinelli ◽  
Sérgio Freitas de Siqueira ◽  
Eduardo Back Sternick ◽  
Anis Rassi ◽  
Roberto Costa ◽  
...  

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Nakao ◽  
M Watanabe ◽  
T Koizumi ◽  
T Kadosaka ◽  
T Koya ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background  The number of patients who received left ventricular assisted device (LVAD) implantation because of end-stage heart failure has been increasing. In those patients, ventricular arrhythmias (VAs) occur commonly, and electrical storm (ES) and shock therapies by implantable cardioverter-defibrillator (ICD) are considered to increase mortality. Although it is important to identify patients with higher risk of VA events, there have been limited data reporting the risk of VAs in LVAD patients during long-term follow up, especially in non-ischemic cardiomyopathy (NICM). Purpose  We sought to clarify the predictors of ICD therapies in LVAD patients diagnosed as NICM during long-term follow up. Methods We retrospectively analyzed non-ischemic heart failure patients whom a continuous flow LVAD was implanted as a bridge to transplantation therapy from July 2011 to February 2019. ICD programming was generally set as follows; one zone setting (VF zone with maximum shocks) for primary prevention or two zone setting (VF with maximum shocks and VT with ATPs and shocks) for secondary prevention. ICD settings were generally unchanged after LVAD implantation. Clinical and echocardiographic data were collected before and 3 months after LVAD implantation. Device interrogation was performed every 4 - 6 months at out-patient clinic. Patients were followed until May 2019. Results A total of 25 patients were included in the study. The mean age was 49 years, 88% were men. They majority of patients (52%) were diagnosed as idiopathic dilated cardiomyopathy. During the median follow up duration of 889 days (IQR 546 – 2070), 27 appropriate shock events occurred in 7 patients and 154 appropriate ATP-only events in 10 patients. The group with appropriate ICD event (11 patients, 44%) had significantly smaller LVDd (65.2 ± 4.0 vs. 79.4 ± 3.5 mm; p = 0.01) and higher LVEF (26.2 ± 1.6 vs. 20.5 ± 1.4 %; p = 0.02) before LVAD implantation. When patients were divided into 2 groups based on the median value (70.0 mm) of LVDd before LVAD implantation (pre LVDd), patients with smaller pre LVDd (≤ 70mm) had significantly higher rate of appropriate ICD treatment than those with larger pre LVDd (&gt; 70 mm) (Log-rank p &lt; 0.01). In univariate cox regression analysis, pre LVDd was negatively associated with appropriate ICD therapy (hazard ratio 0.94, 95% confidence interval 0.88 - 0.99; p = 0.02). Conclusion Smaller LVDd before LVAD implantation might be a possible predictor of appropriate ICD treatment in patients with NICM. Abstract Figure.


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