Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST

Laurence D. Sterns; Mathias Meine; Takashi Kurita; Albert Meijer; Angelo Auricchio; Kenji Ando; Charles T. Leng; Ken Okumura; John L. Sapp; Mark L. Brown; Daniel R. Lexcen; Bart Gerritse; Edward J. Schloss

doi:10.1016/j.hrthm.2016.03.022

Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST

Laurence D. Sterns, Mathias Meine, Takashi Kurita, Albert Meijer, Angelo Auricchio, Kenji Ando, Charles T. Leng, Ken Okumura, John L. Sapp, Mark L. Brown, Daniel R. Lexcen, Bart Gerritse, Edward J. Schloss

Research output: Contribution to journal › Article › peer-review

25 Citations (Scopus)

Abstract

Background Prolonged ventricular fibrillation (VF) detection has been shown to reduce implantable cardioverter-defibrillator (ICD) therapies and improve prognosis in primary prevention ICD patients. Data in secondary prevention patients are limited. Objective The PainFree SST secondary prevention study is the largest trial of secondary prevention patients randomized between standard and prolonged detection to assess the safety of this strategy in these patients. Methods A total of 705 secondary prevention patients implanted with an ICD in the PainFree SST trial were enrolled in this substudy; 353 patients were randomized to VF detection of 18/24 intervals and 352 patients to 30/40. All other VF parameters were standardized by protocol. Results The 1-year arrhythmic syncope-free rates in the standard and prolonged groups were 97.7% vs 96.9%, respectively, (P =.0034 for noninferiority). Freedom from all-cause syncope was 96% in both arms (P =.0013 for noninferiority). There was no difference in the time to first appropriate or inappropriate VF therapy. However, the rates of treated VF episodes were lower in the prolonged arm (1.48 per patient per year vs 0.44 per patient per year, P =.0001). A trend toward lower mortality in the prolonged group was not statistically different (5.6% 1 year, 12% 2 years vs 3.8% 1 year, 7.7% 2 years, adjusted hazard ratio = 0.60, P =.061). Conclusion This large prospective randomized study shows that prolonged detection can safely be programmed in secondary prevention ICD patients with new or existing devices. This programming strategy decreases the rate of treated events and is not associated with an increased risk of syncope or mortality.

Original language	English
Pages (from-to)	1489-1496
Number of pages	8
Journal	Heart Rhythm
Volume	13
Issue number	7
DOIs	https://doi.org/10.1016/j.hrthm.2016.03.022
Publication status	Published - Jul 1 2016
Externally published	Yes

Bibliographical note

Funding Information:
Dr Sterns has done research for Medtronic, Boston Scientific, and St Jude Medical. Dr Kurita has done research for Medtronic, Boston Scientific, St Jude, and Biotronik. Dr Meijer has received consultancy fees and fellowship support from Medtronic and St Jude Medical. Dr Auricchio is a consultant to Abbott, Biosense Webster, Bristol-Myers Squibb, Boston Scientific, Cardiotek-Schwarzer, Cordis Biologics Delivery Systems, DC Devices, Leadexx, Medtronic, Resmed, Respicardia, Schiller AG, Sorin Group, and St Jude and received speaker’s fees from Boston Scientific, Medtronic, Resmed, Respicardia, and Sorin Group. Dr Ando has done research for Medtronic. Dr Okumura has received grants and done research for Johnson & Johnson K. K. and Medtronic Japan. Dr Sapp has done research for Medtronic and St Jude Medical and received grants from St Jude Medical, Biosense Webster, and Philips. Drs Brown, Lexcen, and Gerritse are employees of Medtronic, Inc. Dr Schloss has done research for Medtronic and Boston Scientific. This study was funded by Medtronic, Inc, Minneapolis, MN. The sponsor was involved in the study design and managed the collection of data as well as data analysis. The interpretation of the data and writing of the report had involvement of Medtronic co-authors as listed in the disclosures. The decision to submit the article for publication was made by the authors. ClinicalTrials.gov Identifier: NCT00982397.

Publisher Copyright:
© 2016 Heart Rhythm Society.

ASJC Scopus Subject Areas

Cardiology and Cardiovascular Medicine
Physiology (medical)

PubMed: MeSH publication types

Journal Article
Randomized Controlled Trial

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10.1016/j.hrthm.2016.03.022

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Sterns, L. D., Meine, M., Kurita, T., Meijer, A., Auricchio, A., Ando, K., Leng, C. T., Okumura, K., Sapp, J. L., Brown, M. L., Lexcen, D. R., Gerritse, B., & Schloss, E. J. (2016). Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST. Heart Rhythm, 13(7), 1489-1496. https://doi.org/10.1016/j.hrthm.2016.03.022

Sterns, LD, Meine, M, Kurita, T, Meijer, A, Auricchio, A, Ando, K, Leng, CT, Okumura, K, Sapp, JL, Brown, ML, Lexcen, DR, Gerritse, B & Schloss, EJ 2016, 'Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST', Heart Rhythm, vol. 13, no. 7, pp. 1489-1496. https://doi.org/10.1016/j.hrthm.2016.03.022

@article{88f9559cd8aa4fc29ae6ecbc808b50ea,

title = "Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST",

abstract = "Background Prolonged ventricular fibrillation (VF) detection has been shown to reduce implantable cardioverter-defibrillator (ICD) therapies and improve prognosis in primary prevention ICD patients. Data in secondary prevention patients are limited. Objective The PainFree SST secondary prevention study is the largest trial of secondary prevention patients randomized between standard and prolonged detection to assess the safety of this strategy in these patients. Methods A total of 705 secondary prevention patients implanted with an ICD in the PainFree SST trial were enrolled in this substudy; 353 patients were randomized to VF detection of 18/24 intervals and 352 patients to 30/40. All other VF parameters were standardized by protocol. Results The 1-year arrhythmic syncope-free rates in the standard and prolonged groups were 97.7% vs 96.9%, respectively, (P =.0034 for noninferiority). Freedom from all-cause syncope was 96% in both arms (P =.0013 for noninferiority). There was no difference in the time to first appropriate or inappropriate VF therapy. However, the rates of treated VF episodes were lower in the prolonged arm (1.48 per patient per year vs 0.44 per patient per year, P =.0001). A trend toward lower mortality in the prolonged group was not statistically different (5.6% 1 year, 12% 2 years vs 3.8% 1 year, 7.7% 2 years, adjusted hazard ratio = 0.60, P =.061). Conclusion This large prospective randomized study shows that prolonged detection can safely be programmed in secondary prevention ICD patients with new or existing devices. This programming strategy decreases the rate of treated events and is not associated with an increased risk of syncope or mortality.",

author = "Sterns, {Laurence D.} and Mathias Meine and Takashi Kurita and Albert Meijer and Angelo Auricchio and Kenji Ando and Leng, {Charles T.} and Ken Okumura and Sapp, {John L.} and Brown, {Mark L.} and Lexcen, {Daniel R.} and Bart Gerritse and Schloss, {Edward J.}",

note = "Funding Information: Dr Sterns has done research for Medtronic, Boston Scientific, and St Jude Medical. Dr Kurita has done research for Medtronic, Boston Scientific, St Jude, and Biotronik. Dr Meijer has received consultancy fees and fellowship support from Medtronic and St Jude Medical. Dr Auricchio is a consultant to Abbott, Biosense Webster, Bristol-Myers Squibb, Boston Scientific, Cardiotek-Schwarzer, Cordis Biologics Delivery Systems, DC Devices, Leadexx, Medtronic, Resmed, Respicardia, Schiller AG, Sorin Group, and St Jude and received speaker{\textquoteright}s fees from Boston Scientific, Medtronic, Resmed, Respicardia, and Sorin Group. Dr Ando has done research for Medtronic. Dr Okumura has received grants and done research for Johnson & Johnson K. K. and Medtronic Japan. Dr Sapp has done research for Medtronic and St Jude Medical and received grants from St Jude Medical, Biosense Webster, and Philips. Drs Brown, Lexcen, and Gerritse are employees of Medtronic, Inc. Dr Schloss has done research for Medtronic and Boston Scientific. This study was funded by Medtronic, Inc, Minneapolis, MN. The sponsor was involved in the study design and managed the collection of data as well as data analysis. The interpretation of the data and writing of the report had involvement of Medtronic co-authors as listed in the disclosures. The decision to submit the article for publication was made by the authors. ClinicalTrials.gov Identifier: NCT00982397. Publisher Copyright: {\textcopyright} 2016 Heart Rhythm Society.",

year = "2016",

month = jul,

day = "1",

doi = "10.1016/j.hrthm.2016.03.022",

language = "English",

volume = "13",

pages = "1489--1496",

journal = "Heart Rhythm",

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number = "7",

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TY - JOUR

T1 - Extended detection time to reduce shocks is safe in secondary prevention patients

T2 - The secondary prevention substudy of PainFree SST

AU - Sterns, Laurence D.

AU - Meine, Mathias

AU - Kurita, Takashi

AU - Meijer, Albert

AU - Auricchio, Angelo

AU - Ando, Kenji

AU - Leng, Charles T.

AU - Okumura, Ken

AU - Sapp, John L.

AU - Brown, Mark L.

AU - Lexcen, Daniel R.

AU - Gerritse, Bart

AU - Schloss, Edward J.

N1 - Funding Information: Dr Sterns has done research for Medtronic, Boston Scientific, and St Jude Medical. Dr Kurita has done research for Medtronic, Boston Scientific, St Jude, and Biotronik. Dr Meijer has received consultancy fees and fellowship support from Medtronic and St Jude Medical. Dr Auricchio is a consultant to Abbott, Biosense Webster, Bristol-Myers Squibb, Boston Scientific, Cardiotek-Schwarzer, Cordis Biologics Delivery Systems, DC Devices, Leadexx, Medtronic, Resmed, Respicardia, Schiller AG, Sorin Group, and St Jude and received speaker’s fees from Boston Scientific, Medtronic, Resmed, Respicardia, and Sorin Group. Dr Ando has done research for Medtronic. Dr Okumura has received grants and done research for Johnson & Johnson K. K. and Medtronic Japan. Dr Sapp has done research for Medtronic and St Jude Medical and received grants from St Jude Medical, Biosense Webster, and Philips. Drs Brown, Lexcen, and Gerritse are employees of Medtronic, Inc. Dr Schloss has done research for Medtronic and Boston Scientific. This study was funded by Medtronic, Inc, Minneapolis, MN. The sponsor was involved in the study design and managed the collection of data as well as data analysis. The interpretation of the data and writing of the report had involvement of Medtronic co-authors as listed in the disclosures. The decision to submit the article for publication was made by the authors. ClinicalTrials.gov Identifier: NCT00982397. Publisher Copyright: © 2016 Heart Rhythm Society.

PY - 2016/7/1

Y1 - 2016/7/1

N2 - Background Prolonged ventricular fibrillation (VF) detection has been shown to reduce implantable cardioverter-defibrillator (ICD) therapies and improve prognosis in primary prevention ICD patients. Data in secondary prevention patients are limited. Objective The PainFree SST secondary prevention study is the largest trial of secondary prevention patients randomized between standard and prolonged detection to assess the safety of this strategy in these patients. Methods A total of 705 secondary prevention patients implanted with an ICD in the PainFree SST trial were enrolled in this substudy; 353 patients were randomized to VF detection of 18/24 intervals and 352 patients to 30/40. All other VF parameters were standardized by protocol. Results The 1-year arrhythmic syncope-free rates in the standard and prolonged groups were 97.7% vs 96.9%, respectively, (P =.0034 for noninferiority). Freedom from all-cause syncope was 96% in both arms (P =.0013 for noninferiority). There was no difference in the time to first appropriate or inappropriate VF therapy. However, the rates of treated VF episodes were lower in the prolonged arm (1.48 per patient per year vs 0.44 per patient per year, P =.0001). A trend toward lower mortality in the prolonged group was not statistically different (5.6% 1 year, 12% 2 years vs 3.8% 1 year, 7.7% 2 years, adjusted hazard ratio = 0.60, P =.061). Conclusion This large prospective randomized study shows that prolonged detection can safely be programmed in secondary prevention ICD patients with new or existing devices. This programming strategy decreases the rate of treated events and is not associated with an increased risk of syncope or mortality.

AB - Background Prolonged ventricular fibrillation (VF) detection has been shown to reduce implantable cardioverter-defibrillator (ICD) therapies and improve prognosis in primary prevention ICD patients. Data in secondary prevention patients are limited. Objective The PainFree SST secondary prevention study is the largest trial of secondary prevention patients randomized between standard and prolonged detection to assess the safety of this strategy in these patients. Methods A total of 705 secondary prevention patients implanted with an ICD in the PainFree SST trial were enrolled in this substudy; 353 patients were randomized to VF detection of 18/24 intervals and 352 patients to 30/40. All other VF parameters were standardized by protocol. Results The 1-year arrhythmic syncope-free rates in the standard and prolonged groups were 97.7% vs 96.9%, respectively, (P =.0034 for noninferiority). Freedom from all-cause syncope was 96% in both arms (P =.0013 for noninferiority). There was no difference in the time to first appropriate or inappropriate VF therapy. However, the rates of treated VF episodes were lower in the prolonged arm (1.48 per patient per year vs 0.44 per patient per year, P =.0001). A trend toward lower mortality in the prolonged group was not statistically different (5.6% 1 year, 12% 2 years vs 3.8% 1 year, 7.7% 2 years, adjusted hazard ratio = 0.60, P =.061). Conclusion This large prospective randomized study shows that prolonged detection can safely be programmed in secondary prevention ICD patients with new or existing devices. This programming strategy decreases the rate of treated events and is not associated with an increased risk of syncope or mortality.

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Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST

Abstract

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PubMed: MeSH publication types

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