Safety and efficacy of strategic implantable cardioverter-defibrillator programming to reduce the shock delivery burden in a primary prevention patient population

J Interv Card Electrophysiol

Okajima

Shimane

et al. 2017

PurposePatients with implantable cardioverter defibrillators (ICDs) have an ongoing risk of sudden incapacitation that may cause traffic accidents. However, there are limited data on the magnitude of this risk after inappropriate ICD therapies. We studied the rate of syncope associated with inappropriate ICD therapies to provide a scientific basis for formulating driving restrictions.MethodsInappropriate ICD therapy event data between 1997 and 2014 from 50 Japanese institutions were analyzed retrospectively. The annual risk of harm (RH) to others posed by a driver with an ICD was calculated for private driving habits. We used a commonly employed annual RH to others of 5 in 100,000 (0.005%) as an acceptable risk threshold.ResultsOf the 4089 patients, 772 inappropriate ICD therapies occurred in 417 patients (age 61 ± 15 years, 74% male, and 65% secondary prevention). Patients experiencing inappropriate therapies had a mean number of 1.8 ± 1.5 therapy episodes during a median follow-up period of 3.9 years. No significant differences were found in the age, sex, or number of inappropriate therapies between patients receiving ICDs for primary or secondary prevention. Only three patients (0.7%) experienced syncope associated with inappropriate therapies. The maximum annual RH to others after the first therapy in primary and secondary prevention patients was calculated to be 0.11 in 100,000 and 0.12 in 100,000, respectively.ConclusionsWe found that the annual RH from driving was far below the commonly cited acceptable risk threshold. Our data provide useful information to supplement current recommendations on driving restrictions in ICD patients with private driving habits.Electronic supplementary materialThe online version of this article (doi:10.1007/s10840-017-0272-4) contains supplementary material, which is available to authorized users.

Section: Introductionmentioning

confidence: 99%

Inappropriate implantable cardioverter defibrillator shocks—incidence, effect, and implications for driver licensing

J Interv Card Electrophysiol

Okajima

Shimane

et al. 2017

“…In some patients with ICDs/CRT-Ds for primary prevention, the mortality benefit of the ICDs/CRT-Ds is undeniable [13,[17][18][19]. Especially, when comparing ICDs and CRT-Ds, CRT-D-implanted patients had fewer events than ICD-implanted patients, owing to an increased sensitivity in detecting supraventricular tachycardias and improved heart failure in CRT-D patients [8].…”

Section: Discussionmentioning

confidence: 99%

“…In the previous studies [11][12][13], idiopathic VF, BS, and ERS patients were not included in the final analysis. In our study, those patients were also included as structurally normal heart patients.…”

Section: Discussionmentioning

confidence: 99%

“…MADIT-RIT [11] also implied a high-rate cutoff or prolonged detection of ventricular arrhythmias reduces inappropriate ICD shocks. In the PROVE trial [13], investigators demonstrated strategic programming with a chosen rate cutoff and the detection interval was also safe and effective for primary prevention patients. Based on these results, we applied strategic programming protocols since January 2015.…”

Section: Introductionmentioning

confidence: 99%

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Clinical impact of applying strategic programming in patients with implantable cardioverter-defibrillators beyond reducing inappropriate shocks

et al. 2020

Background: The incidence of inappropriate shocks remains high at 30% in patients with implantable cardioverterdefibrillators (ICDs). This retrospective study sought to examine the efficacy of strategic programming (ICD programming with a long detection interval and high-rate cutoff) in reducing electrical storm, inappropriate shocks, and unexpected hospital visits in patients with ICDs with/without cardiac resynchronization therapy with defibrillator (CRT-Ds). Methods: This was a single tertiary center retrospective study, evaluating the clinical outcomes, especially regarding inappropriate therapies in patients with ICDs or CRT-Ds. Enrolled patients underwent ICD or CRT-D implantations from January 2008 to May 2016. Clinical information was attained by a thorough chart review. Results: We analyzed 155 defibrillator patients from January 2008 to May 2016 (124 patients had ICDs and 31 had CRT-Ds). Since we adopted this strategic programming as a default programming from 2015 implanted ICDs and CRT-Ds, we divided the patients into two groups: devices implanted before 2015 (group A, n = 94) versus implanted after 2015 (group B, n = 61). During a median of 1289 days of follow-up, electrical storms occurred in three patients (eight events) in group B versus 11 (28 events) in group A (P = 0.18); appropriate therapies were delivered in 27 patients (56 events) in group A versus 7 (15 events) in group B (P = 0.72); inappropriate therapies were delivered in 15 patients (21 events) in group A versus 1 with 1 episode in group B (P = 0.03); and 5 unexpected hospitalizations occurred in four patients in group B versus 36 in 24 patients in group A (P = 0.02). Conclusion: The clinical application of strategic programming reduced inappropriate shocks and unexpected hospitalizations in ICD and CRT-D patients.

“…The privilege of driving is cherished, but driving restrictions are necessary when it poses a threat to others. According to literature, the rate of syncope or loss of consciousness associated with ICD therapy varies widely [4] , [5] , [6] , [7] , [8] , [9] and [10] . Many countries have regulations for driving restrictions in ICD patients, but large varieties exist between countries [11] , [12] , [13] , [14] , [15] and [16] .…”

Section: Introductionmentioning

confidence: 99%

Driving restrictions in patients with implantable cardioverter defibrillators and pacemakers

Abe

2017

Journal of Arrhythmia

Implantable cardioverter-defibrillators (ICDs) improve the survival in patients at risk of sudden cardiac death. However, these patients have an ongoing risk of sudden incapacitation that may cause harm to individuals and others when driving. Considerable disagreement exists about whether and when these patients should be allowed to resume driving after ICD therapies. This information is critical for the management decisions to avoid future potentially lethal incidents and unnecessary restrictions for ICD patients. The cardiac implantable device committee of the Japanese Heart Rhythm Society reassessed the risk of driving for ICD patients based on the literature and domestic data. We reviewed the driving restrictions of ICD patients in various regions and here present updated Japanese driving restrictions.