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 ◽  
...  

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.

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 ◽  
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.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sisir Siddamsetti ◽  
Mojgan Golzy ◽  
Sandeep Gautam

Introduction: Cardiac amyloidosis is associated with high risk for sudden cardiac death. However, the potential benefit of implantable cardioverter defibrillator (ICD) implantation in CA is unknown due to limited available data regarding outcomes following ICD implantation in this patient population. We sought to perform a meta-analysis of trials that evaluated the outcomes of ICD implantation in CA. Methods: We performed a systematic literature review in PubMed, SCOPUS, and Cochrane to identify all studies that evaluated ICD therapy in CA until May 2020. Outcomes analyzed were all-cause mortality and appropriate ICD therapy rates. A random effects model was used to calculate percentages and 95% confidence intervals (CI) of outcomes. Results: Of the screened articles, 5 observational studies were included for analysis. A total of 151 patients were analyzed. Mean age of population was 61.6 +/- 0.7 years and 79.2% were male. The all-cause mortality rate was 33% (95% CI:16 to 51%) and the incidence of appropriate ICD therapy was 23% (95% CI:16 to 30%) over a mean follow up period of 16 months (Figure). In trials that evaluated ICD therapy in non-ischemic cardiomyopathy such as DANISH, DEFINITE and SCD-HeFT trials mortality rates in the ICD arm were 21.6 % over 67.6 months, 9.4% over 29 months and 16.7% over 45.5 months, respectively. The incidence of appropriate therapy in DANISH, DEFINITE and SCD-HeFT trials were 28.9%, 19.8 % and 21% respectively. Conclusions: CA patients with ICD have equivalent appropriate therapy with disproportionately higher mortality over a shorter follow up compared to randomized trials of primary prevention ICD placement in NICMP. The benefit of ICD placement for mortality reduction in CA remains unclear and further large-scale studies are required to address this issue.


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

Author(s):  
Victor Nauffal ◽  
Peter Marstrand ◽  
Larry Han ◽  
Victoria N Parikh ◽  
Adam S Helms ◽  
...  

Abstract Aims  Risk stratification algorithms for sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM) and regional differences in clinical practice have evolved over time. We sought to compare primary prevention implantable cardioverter defibrillator (ICD) implantation rates and associated clinical outcomes in US vs. non-US tertiary HCM centres within the international Sarcomeric Human Cardiomyopathy Registry. Methods and results We included patients with HCM enrolled from eight US sites (n = 2650) and five non-US (n = 2660) sites and used multivariable Cox-proportional hazards models to compare outcomes between sites. Primary prevention ICD implantation rates in US sites were two-fold higher than non-US sites (hazard ratio (HR) 2.27 [1.89–2.74]), including in individuals deemed at high 5-year SCD risk (≥6%) based on the HCM risk-SCD score (HR 3.27 [1.76–6.05]). US ICD recipients also had fewer traditional SCD risk factors. Among ICD recipients, rates of appropriate ICD therapy were significantly lower in US vs. non-US sites (HR 0.52 [0.28–0.97]). No significant difference was identified in the incidence of SCD/resuscitated cardiac arrest among non-recipients of ICDs in US vs. non-US sites (HR 1.21 [0.74–1.97]). Conclusion  Primary prevention ICDs are implanted more frequently in patients with HCM in US vs. non-US sites across the spectrum of SCD risk. There was a lower rate of appropriate ICD therapy in US sites, consistent with a lower-risk population, and no significant difference in SCD in US vs. non-US patients who did not receive an ICD. Further studies are needed to understand what drives malignant arrhythmias, optimize ICD allocation, and examine the impact of different ICD utilization strategies on long-term outcomes in HCM.


2021 ◽  
Vol 11 (1) ◽  
pp. 121
Author(s):  
Marco Canepa ◽  
Pietro Palmisano ◽  
Gabriele Dell’Era ◽  
Matteo Ziacchi ◽  
Ernesto Ammendola ◽  
...  

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.


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


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