Long-Term Follow-Up of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

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.

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

European Heart Journal ◽

10.1093/ehjci/ehaa946.0792 ◽

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

BMC Cardiovascular Disorders ◽

10.1186/s12872-019-1218-9 ◽

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.

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Faculty Opinions recommendation of Long-Term Follow-Up of Patients with Tetralogy of Fallot and Implantable Cardioverter Defibrillator: The DAI-T4F (Implantable Cardioverter Defibrillator-Tetralogy of Fallot) Nationwide Registry.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.738783850.793579822 ◽

2020 ◽

Author(s):

Marlon Rosenbaum

Keyword(s):

Implantable Cardioverter Defibrillator ◽

Tetralogy Of Fallot ◽

Cardioverter Defibrillator ◽

Nationwide Registry ◽

Long Term Follow Up

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

Pacing and Clinical Electrophysiology ◽

10.1111/pace.13333 ◽

2018 ◽

Vol 41 (6) ◽

pp. 583-588 ◽

Cited By ~ 2

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

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Abstract 14575: Implantable Cardiac Defibrillator in the Setting of Tetralogy of Fallot: Long-Term Follow-Up of a French National Multicenter Retrospective Registry

Circulation ◽

10.1161/circ.132.suppl_3.14575 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Abdeslam Bouzeman ◽

Maxime De Guillebon ◽

Guillaume Duthoit ◽

Magalie Ladouceur ◽

Raphael Martins ◽

...

Keyword(s):

Risk Factors ◽

Ventricular Tachycardia ◽

Primary Prevention ◽

Secondary Prevention ◽

Tetralogy Of Fallot ◽

Primary And Secondary Prevention ◽

Long Term Follow Up ◽

Appropriate Therapy

Background: Tetralogy of Fallot (TOF) is the most frequent form of congenital heart disease managed by EP physicians for potential ICD. However, few studies have reported long-term outcomes of TOF patients with ICD. Methods: Between 2005 and 2014, all TOF patients with ICD in 17 French centers were enrolled in a specific evaluation aiming to determine characteristics at implantation as well as outcomes (overall mortality, appropriate ICD therapies, and device-related complications). Results: Overall 78 patients (45±13 years, 64% males) were enrolled. A majority of patients were implanted in the setting of secondary prevention (73%), whereas the remaining (27%) in primary prevention. Among the latest group, known risk factors for sudden cardiac death were: severe pulmonary regurgitation (30%,) prior palliative shunt (50%), syncope with unknown origin (25%), inducible ventricular tachycardia (45%), QRS duration ≥180ms (18%), non-sustained ventricular tachycardia (25%), and documented sustained supra ventricular tachycardia (45%).Overall, patients implanted in the setting of primary prevention presented with a mean of 3.1±1.4 risk factors. After a mean follow-up of 4.9±3.8 years, 35 patients (45%) experienced at least one appropriate therapy (25% in the primary prevention group compared to 53% in the secondary prevention group), giving annual-incidences of 6.9% (95%CI 0.14-13.7) and 21.3% (12.4-30.3) respectively (P=0,01). The mean time between ICD implantation and the first appropriate therapy was 2.2±3.2 years, without significant differences between primary and secondary prevention. Overall, ≥one ICD-related complication occurred in 30 patients (38%), including inappropriate shock (n=9), major pocket hematoma (n=1), lead dysfunction (n=12), infection (n=4), shoulder algodystrophia (n=2), device failure or dislodgement needing reintervention (n=2). Eventually, four patients were transplanted (5%), and six patients (8%) died during the course of follow-up. Conclusions: Considering relatively long-term follow-up, patients with TOF and ICDs experience high rates of appropriate ICD therapies, in both primary and secondary prevention. Major ICD-related complications remain, however, high.

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