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

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Abdeslam Bouzeman ◽  
Maxime De Guillebon ◽  
Guillaume Duthoit ◽  
Magalie Ladouceur ◽  
Raphael Martins ◽  
...  

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.

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


EP Europace ◽  
2011 ◽  
Vol 13 (3) ◽  
pp. 389-394 ◽  
Author(s):  
G. H. van Welsenes ◽  
J. B. van Rees ◽  
C. J. W. Borleffs ◽  
S. C. Cannegieter ◽  
J. J. Bax ◽  
...  

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.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Waldmann ◽  
A Bouzeman ◽  
F Bessiere ◽  
F Labombarda ◽  
M Ladouceur ◽  
...  

Abstract Background Ventricular arrhythmias and sudden death are feared late complications in patients with tetralogy of Fallot. Selection of candidates for primary prevention implantable cardioverter defibrillator (ICD) remains challenging in this population. Non-sustained ventricular tachycardia (NSVT), altered left ventricular ejection fraction (LVEF), positive programmed ventricular stimulation, and enlarged QRS are currently used for risk stratification. Purpose To identify high-risk patients with tetralogy of Fallot in the setting of primary prevention of sudden cardiac death. Methods The DAI-T4F study is a large ongoing national French registry including all patients with tetralogy of Fallot and ICD (NCT03837574). Information have been collected prospectively since 2010 with annual update. Baseline patient characteristics and clinical events during the follow-up were analyzed with central adjudication. Cox proportional hazard models were used to identify factors associated with appropriate ICD therapies. Results Among 134 patients enrolled, 47 (35.1%) underwent ICD implantation for primary prevention (median age 49.1 years, 76.6% males). At baseline, 20 (42.6%) patients had NSVT, 17 (36.2%) had severe altered LVEF ≤35%, 16 (34.0%) had positive programmed ventricular stimulation, and 16 (34.0%) had QRS duration ≥180ms. Overall, 20 (42.6%), 15 (31.9%), and 6 (12.8%) patients had respectively one, two, or ≥ three of these risk factors. Six (12.8%) patients were implanted for other indications. During a median (IQR) follow-up duration of 5.3 (2.1–8.0) years, 14 (29.8%) patients had at least one appropriate ICD therapy. The annual incidence of appropriate ICD therapies were 2.8%, 4.6%, 6.3%, and 8.6% in patients with none, one, two, or ≥ three of these factors (p for trend = 0.145). None of predictors, considered isolated, was significantly associated with ICD appropriate therapies. Patients with non-sustained ventricular tachycardia (NSVT) and positive programmed ventricular stimulation had a significant increased risk of ICD appropriate therapies (HR=3.8, 95% CI: 1.1–14.3, p=0.035), as well as patients with NSVT and QRSd ≥180 ms (HR=7.2, 95% CI: 1.6–32.7, p=0.003). No patient with severe altered LVEF without other risk factor had appropriate ICD therapy. Patients with congestive heart failure and/or altered LVEF had a higher risk of non-sudden death or cardiac transplantation (HR=14.4, 95% CI: 1.8–112.7, p<0.001). Seventeen (36.2%) patients experienced at least one ICD-related complication. Conclusions Our data illustrate that specific risk stratification and primary prevention for sudden cardiac death in patients with tetralogy of Fallot may be improved. The value of a severely altered LVEF appears low in the absence of other risk factors, and combination of different predictors is essential. The high rate of complications as well as consideration of competing risk situation have to be integrated in the benefit-risk equation.


2021 ◽  
pp. 000348942110155
Author(s):  
Leonard Haller ◽  
Khush Mehul Kharidia ◽  
Caitlin Bertelsen ◽  
Jeffrey Wang ◽  
Karla O’Dell

Objective: We sought to identify risk factors associated with long-term dysphagia, characterize changes in dysphagia over time, and evaluate the incidence of otolaryngology referrals for patients with long-term dysphagia following anterior cervical discectomy with fusion (ACDF). Methods: About 56 patients who underwent ACDF between May 2017 to February 2019 were included in the study. All patients were assessed for dysphagia using the Eating Assessment Tool (EAT-10) survey preoperatively and late postoperatively (≥1 year). Additionally, 28 patients were assessed for dysphagia early postoperatively (2 weeks—3 months). Demographic data, medical comorbidities, intraoperative details, and post-operative otolaryngology referral rates were collected from electronic medical records. Results: Of the 56 patients enrolled, 21 patients (38%) had EAT-10 scores of 3 or more at long-term follow-up. None of the demographics, comorbidities, or surgical factors assessed were associated with long-term dysphagia. Patients who reported no long-term dysphagia had a mean EAT-10 score of 6.9 early postoperatively, while patients with long-term symptoms had a mean score of 18.1 ( P = .006). Of the 21 patients who reported persistent dysphagia symptoms, 3 (14%) received dysphagia testing or otolaryngology referrals post-operatively. Conclusion: Dysphagia is a notable side effect of ACDF surgery, but there are no significant demographics, comorbidities, or surgical risk factors that predict long-term dysphagia. Early postoperative characterization of dysphagia using the EAT-10 questionnaire can help predict long-term symptoms. There is inadequate screening and otolaryngology follow-up for patients with post-ACDF dysphagia.


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