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

Eiichi Watanabe, Katsunori Okajima, Akira Shimane, Tomoya Ozawa, Tetsuyuki Manaka, Itsuro Morishima, Toru Asai, Masahiko Takagi, Toshihiro Honda, Atsunobu Kasai, Eitaro Fujii, Kohei Yamashiro, Ritsuko Kohno, Haruhiko Abe, Takashi Noda, Takashi Kurita, Shigeyuki Watanabe, Hiroya Ohmori, Takashi Nitta, Yoshifusa AizawaKen Kiyono, Ken Okumura

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose: Patients 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. Methods: Inappropriate 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. Results: Of 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. Conclusions: We 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.

Original languageEnglish
Pages (from-to)271-280
Number of pages10
JournalJournal of Interventional Cardiac Electrophysiology
Volume49
Issue number3
DOIs
Publication statusPublished - 01-09-2017

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Implantable Defibrillators
Licensure
Secondary Prevention
Therapeutics
Syncope
Primary Prevention
Habits
Traffic Accidents

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Watanabe, Eiichi ; Okajima, Katsunori ; Shimane, Akira ; Ozawa, Tomoya ; Manaka, Tetsuyuki ; Morishima, Itsuro ; Asai, Toru ; Takagi, Masahiko ; Honda, Toshihiro ; Kasai, Atsunobu ; Fujii, Eitaro ; Yamashiro, Kohei ; Kohno, Ritsuko ; Abe, Haruhiko ; Noda, Takashi ; Kurita, Takashi ; Watanabe, Shigeyuki ; Ohmori, Hiroya ; Nitta, Takashi ; Aizawa, Yoshifusa ; Kiyono, Ken ; Okumura, Ken. / Inappropriate implantable cardioverter defibrillator shocks—incidence, effect, and implications for driver licensing. In: Journal of Interventional Cardiac Electrophysiology. 2017 ; Vol. 49, No. 3. pp. 271-280.
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abstract = "Purpose: Patients 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. Methods: Inappropriate 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. Results: Of 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. Conclusions: We 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.",
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Watanabe, E, Okajima, K, Shimane, A, Ozawa, T, Manaka, T, Morishima, I, Asai, T, Takagi, M, Honda, T, Kasai, A, Fujii, E, Yamashiro, K, Kohno, R, Abe, H, Noda, T, Kurita, T, Watanabe, S, Ohmori, H, Nitta, T, Aizawa, Y, Kiyono, K & Okumura, K 2017, 'Inappropriate implantable cardioverter defibrillator shocks—incidence, effect, and implications for driver licensing', Journal of Interventional Cardiac Electrophysiology, vol. 49, no. 3, pp. 271-280. https://doi.org/10.1007/s10840-017-0272-4

Inappropriate implantable cardioverter defibrillator shocks—incidence, effect, and implications for driver licensing. / Watanabe, Eiichi; Okajima, Katsunori; Shimane, Akira; Ozawa, Tomoya; Manaka, Tetsuyuki; Morishima, Itsuro; Asai, Toru; Takagi, Masahiko; Honda, Toshihiro; Kasai, Atsunobu; Fujii, Eitaro; Yamashiro, Kohei; Kohno, Ritsuko; Abe, Haruhiko; Noda, Takashi; Kurita, Takashi; Watanabe, Shigeyuki; Ohmori, Hiroya; Nitta, Takashi; Aizawa, Yoshifusa; Kiyono, Ken; Okumura, Ken.

In: Journal of Interventional Cardiac Electrophysiology, Vol. 49, No. 3, 01.09.2017, p. 271-280.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Inappropriate implantable cardioverter defibrillator shocks—incidence, effect, and implications for driver licensing

AU - Watanabe, Eiichi

AU - Okajima, Katsunori

AU - Shimane, Akira

AU - Ozawa, Tomoya

AU - Manaka, Tetsuyuki

AU - Morishima, Itsuro

AU - Asai, Toru

AU - Takagi, Masahiko

AU - Honda, Toshihiro

AU - Kasai, Atsunobu

AU - Fujii, Eitaro

AU - Yamashiro, Kohei

AU - Kohno, Ritsuko

AU - Abe, Haruhiko

AU - Noda, Takashi

AU - Kurita, Takashi

AU - Watanabe, Shigeyuki

AU - Ohmori, Hiroya

AU - Nitta, Takashi

AU - Aizawa, Yoshifusa

AU - Kiyono, Ken

AU - Okumura, Ken

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Purpose: Patients 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. Methods: Inappropriate 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. Results: Of 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. Conclusions: We 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.

AB - Purpose: Patients 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. Methods: Inappropriate 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. Results: Of 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. Conclusions: We 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.

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