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The impact of SMARTpass algorithm status on inappropriate shock rates in the UNTOUCHED Study

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Τίτλος: The impact of SMARTpass algorithm status on inappropriate shock rates in the UNTOUCHED Study
Συγγραφείς: Boersma, LVA, Aasbo, J, Knops, RE, Lambiase, PD, Bongiorni, MG, Deharo, JC, Russo, AM, Burke, MC, Shakir, A, Huang, DT, Appl, U, Brisben, A, Carter, N, El-Chami, MF, Gold, MR
Πηγή: EP Europace ; volume 24, issue Supplement_1 ; ISSN 1099-5129 1532-2092
Στοιχεία εκδότη: Oxford University Press (OUP)
Έτος έκδοσης: 2022
Περιγραφή: Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific Corporation Background The current Subcutaneous ICD (S-ICD) model incorporates SMART Pass (SP) to improve sensing and discrimination capabilities to reduce inappropriate shocks (IAS). SP status is programmable but may also be disabled automatically in the setting of low amplitude signals or low heart rate in order to avoid under-sensing of VT/VF. Objective To evaluate SP impact on IAS, appropriate shocks (AS), complications and mortality in the UNTOUCHED S-ICD trial. Methods Primary prevention patients (pts, n=1111) with ejection fraction ≤35% and no pacing requirement were followed for up to 18 months. SP status during a study visit was programmed ON or OFF and status between visits was either consistently OFF, ON, or automatically disabled (DIS). The impact of SP status on pt outcomes was evaluated using Kaplan-Meier (K-M) analysis. Multivariable proportional hazard analysis identified predictors of IAS and SP disable events. Results Percent of pts with SP always ON, always OFF, ON with DIS, and OFF then ON with no DIS were 56, 16, 15, and 13%, respectively. At least one SP DIS occurred in 177 pts, but only 13% had 2 or more, mostly due to PVCs and low EGM amplitudes. Significant multivariable predictors of SP disable events are history of atrial fibrillation (hazard ratio (HR) 2.49, odds ratio (OR) (1.49-4.16); p=.0005), only one passing vector at S-ICD screening, (HR 1.85, OR (1.10-3.10; p=.0202) and lower left ventricular ejection fraction (HR 1.05, OR (1.01-1.08); p=.0074). K-M IAS rates were highest for pts experiencing DIS (fig 1) and lowest for SP ON. While neither AS (p=0.58) nor complication (p=0.58) rates varied significantly according to SP status, mortality was lower for pts with SP ON during any duration of time (p=0.044) by univariate analysis. Further analysis is planned to better understand the relationship between SP status and mortality. Conclusion Patients in the UNTOUCHED ...
Τύπος εγγράφου: article in journal/newspaper
Γλώσσα: English
DOI: 10.1093/europace/euac053.391
Διαθεσιμότητα: https://doi.org/10.1093/europace/euac053.391
https://academic.oup.com/europace/article-pdf/24/Supplement_1/euac053.391/43769554/euac053.391.pdf
Rights: https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model
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  Data: The impact of SMARTpass algorithm status on inappropriate shock rates in the UNTOUCHED Study
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  Data: EP Europace ; volume 24, issue Supplement_1 ; ISSN 1099-5129 1532-2092
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  Data: Oxford University Press (OUP)
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  Data: 2022
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  Data: Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific Corporation Background The current Subcutaneous ICD (S-ICD) model incorporates SMART Pass (SP) to improve sensing and discrimination capabilities to reduce inappropriate shocks (IAS). SP status is programmable but may also be disabled automatically in the setting of low amplitude signals or low heart rate in order to avoid under-sensing of VT/VF. Objective To evaluate SP impact on IAS, appropriate shocks (AS), complications and mortality in the UNTOUCHED S-ICD trial. Methods Primary prevention patients (pts, n=1111) with ejection fraction ≤35% and no pacing requirement were followed for up to 18 months. SP status during a study visit was programmed ON or OFF and status between visits was either consistently OFF, ON, or automatically disabled (DIS). The impact of SP status on pt outcomes was evaluated using Kaplan-Meier (K-M) analysis. Multivariable proportional hazard analysis identified predictors of IAS and SP disable events. Results Percent of pts with SP always ON, always OFF, ON with DIS, and OFF then ON with no DIS were 56, 16, 15, and 13%, respectively. At least one SP DIS occurred in 177 pts, but only 13% had 2 or more, mostly due to PVCs and low EGM amplitudes. Significant multivariable predictors of SP disable events are history of atrial fibrillation (hazard ratio (HR) 2.49, odds ratio (OR) (1.49-4.16); p=.0005), only one passing vector at S-ICD screening, (HR 1.85, OR (1.10-3.10; p=.0202) and lower left ventricular ejection fraction (HR 1.05, OR (1.01-1.08); p=.0074). K-M IAS rates were highest for pts experiencing DIS (fig 1) and lowest for SP ON. While neither AS (p=0.58) nor complication (p=0.58) rates varied significantly according to SP status, mortality was lower for pts with SP ON during any duration of time (p=0.044) by univariate analysis. Further analysis is planned to better understand the relationship between SP status and mortality. Conclusion Patients in the UNTOUCHED ...
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  Data: 10.1093/europace/euac053.391
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