Rationale, design, and endpoints of the ‘DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)’ study: Prospective multicenter observational study of device-detected tachyarrhythmia and sleep-disordered breathing

Hye Bin Gwag, Youngjun Park, Seong Soo Lee, June Soo Kim, Kyoung Min Park, Young Keun On, Dae In Lee, Dong Gu Shin, Eue Keun Choi, Gu Hyun Kang, Hyoung Seob Park, Hyung Wook Park, Jaemin Shim, Jae Sun Uhm, Jun Kim, Jun Hyung Kim, Ki Woon Kang, Sang Weon Park, Yong Seog Oh, Youngjin ChoYoung Soo Lee, Seung Jung Park

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Few studies have investigated the prognostic value of cardiac implantable electronic device (CIED)-detection of sleep-disordered breathing (SDB) for risk stratification of cardiovascular events. In the Device-Detected CArdiac Tachyarrhythmic events and Sleep-disordered breathing (DEDiCATES) study, we aim to determine whether device-detected SDB events are associated with increased risk of cardiac arrhythmias or other cardiovascular outcomes. Methods and design: Six-hundred patients (300 patients with low-voltage pacing devices and 300 with high-voltage defibrillator devices) who have dual chamber CIEDs with AP Scan™ function (Boston Scientific Inc., Marlborough, MA, USA) are planned to be enrolled in this study. AP Scan reports the average number of sleep disturbance events per hour per night in the form of a Respiratory Disturbance Index (RDI). The daily RDI values are to be used for quantitative measurement of the severity and burden of SDB. CIED-detected atrial high rate episodes (AHREs) and clinical atrial tachyarrhythmia will be assessed as the primary outcomes over a follow-up period of 2 years. Correlations between CIED-detected SDB and AHRE burdens will be analyzed. The secondary outcomes are CIED-detected or clinical ventricular arrhythmic events, stroke, heart failure hospitalization, mortality, and quality of life. Conclusion: This study will determine the prognostic value of automated diagnostic function of CIED for SDB, which will help to improve the cardiovascular prognoses of CIED patients by enabling convenient and accurate assessments of SDB events.

Original languageEnglish
JournalInternational Journal of Cardiology
DOIs
Publication statusAccepted/In press - 2019 Jan 1

Fingerprint

Equipment Design
Sleep Apnea Syndromes
Tachycardia
Multicenter Studies
Observational Studies
Prospective Studies
Equipment and Supplies
Defibrillators
Cardiac Arrhythmias
Sleep
Hospitalization
Heart Failure
Stroke
Quality of Life

Keywords

  • Arrhythmia
  • Cardiac implantable electronic device
  • Obstructive sleep apnea
  • Sleep-disordered breathing

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Rationale, design, and endpoints of the ‘DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)’ study : Prospective multicenter observational study of device-detected tachyarrhythmia and sleep-disordered breathing. / Gwag, Hye Bin; Park, Youngjun; Lee, Seong Soo; Kim, June Soo; Park, Kyoung Min; On, Young Keun; Lee, Dae In; Shin, Dong Gu; Choi, Eue Keun; Kang, Gu Hyun; Park, Hyoung Seob; Park, Hyung Wook; Shim, Jaemin; Uhm, Jae Sun; Kim, Jun; Kim, Jun Hyung; Kang, Ki Woon; Park, Sang Weon; Oh, Yong Seog; Cho, Youngjin; Lee, Young Soo; Park, Seung Jung.

In: International Journal of Cardiology, 01.01.2019.

Research output: Contribution to journalArticle

Gwag, Hye Bin ; Park, Youngjun ; Lee, Seong Soo ; Kim, June Soo ; Park, Kyoung Min ; On, Young Keun ; Lee, Dae In ; Shin, Dong Gu ; Choi, Eue Keun ; Kang, Gu Hyun ; Park, Hyoung Seob ; Park, Hyung Wook ; Shim, Jaemin ; Uhm, Jae Sun ; Kim, Jun ; Kim, Jun Hyung ; Kang, Ki Woon ; Park, Sang Weon ; Oh, Yong Seog ; Cho, Youngjin ; Lee, Young Soo ; Park, Seung Jung. / Rationale, design, and endpoints of the ‘DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)’ study : Prospective multicenter observational study of device-detected tachyarrhythmia and sleep-disordered breathing. In: International Journal of Cardiology. 2019.
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abstract = "Background: Few studies have investigated the prognostic value of cardiac implantable electronic device (CIED)-detection of sleep-disordered breathing (SDB) for risk stratification of cardiovascular events. In the Device-Detected CArdiac Tachyarrhythmic events and Sleep-disordered breathing (DEDiCATES) study, we aim to determine whether device-detected SDB events are associated with increased risk of cardiac arrhythmias or other cardiovascular outcomes. Methods and design: Six-hundred patients (300 patients with low-voltage pacing devices and 300 with high-voltage defibrillator devices) who have dual chamber CIEDs with AP Scan™ function (Boston Scientific Inc., Marlborough, MA, USA) are planned to be enrolled in this study. AP Scan reports the average number of sleep disturbance events per hour per night in the form of a Respiratory Disturbance Index (RDI). The daily RDI values are to be used for quantitative measurement of the severity and burden of SDB. CIED-detected atrial high rate episodes (AHREs) and clinical atrial tachyarrhythmia will be assessed as the primary outcomes over a follow-up period of 2 years. Correlations between CIED-detected SDB and AHRE burdens will be analyzed. The secondary outcomes are CIED-detected or clinical ventricular arrhythmic events, stroke, heart failure hospitalization, mortality, and quality of life. Conclusion: This study will determine the prognostic value of automated diagnostic function of CIED for SDB, which will help to improve the cardiovascular prognoses of CIED patients by enabling convenient and accurate assessments of SDB events.",
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T1 - Rationale, design, and endpoints of the ‘DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)’ study

T2 - Prospective multicenter observational study of device-detected tachyarrhythmia and sleep-disordered breathing

AU - Gwag, Hye Bin

AU - Park, Youngjun

AU - Lee, Seong Soo

AU - Kim, June Soo

AU - Park, Kyoung Min

AU - On, Young Keun

AU - Lee, Dae In

AU - Shin, Dong Gu

AU - Choi, Eue Keun

AU - Kang, Gu Hyun

AU - Park, Hyoung Seob

AU - Park, Hyung Wook

AU - Shim, Jaemin

AU - Uhm, Jae Sun

AU - Kim, Jun

AU - Kim, Jun Hyung

AU - Kang, Ki Woon

AU - Park, Sang Weon

AU - Oh, Yong Seog

AU - Cho, Youngjin

AU - Lee, Young Soo

AU - Park, Seung Jung

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Few studies have investigated the prognostic value of cardiac implantable electronic device (CIED)-detection of sleep-disordered breathing (SDB) for risk stratification of cardiovascular events. In the Device-Detected CArdiac Tachyarrhythmic events and Sleep-disordered breathing (DEDiCATES) study, we aim to determine whether device-detected SDB events are associated with increased risk of cardiac arrhythmias or other cardiovascular outcomes. Methods and design: Six-hundred patients (300 patients with low-voltage pacing devices and 300 with high-voltage defibrillator devices) who have dual chamber CIEDs with AP Scan™ function (Boston Scientific Inc., Marlborough, MA, USA) are planned to be enrolled in this study. AP Scan reports the average number of sleep disturbance events per hour per night in the form of a Respiratory Disturbance Index (RDI). The daily RDI values are to be used for quantitative measurement of the severity and burden of SDB. CIED-detected atrial high rate episodes (AHREs) and clinical atrial tachyarrhythmia will be assessed as the primary outcomes over a follow-up period of 2 years. Correlations between CIED-detected SDB and AHRE burdens will be analyzed. The secondary outcomes are CIED-detected or clinical ventricular arrhythmic events, stroke, heart failure hospitalization, mortality, and quality of life. Conclusion: This study will determine the prognostic value of automated diagnostic function of CIED for SDB, which will help to improve the cardiovascular prognoses of CIED patients by enabling convenient and accurate assessments of SDB events.

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KW - Arrhythmia

KW - Cardiac implantable electronic device

KW - Obstructive sleep apnea

KW - Sleep-disordered breathing

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