Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement

Howard C. Herrmann; David J. Cohen; Rebecca T. Hahn; Vasilis C. Babaliaros; Xiao Yu; Raj Makkar; James McCabe; Molly Szerlip; Samir Kapadia; Mark Russo; S. Chris Malaisrie; John G. Webb; Wilson Y. Szeto; Susheel Kodali; Vinod H. Thourani; Michael J. Mack; Martin B. Leon

doi:10.1161/CIRCINTERVENTIONS.120.010310

Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement

Howard C. Herrmann^*, David J. Cohen, Rebecca T. Hahn, Vasilis C. Babaliaros, Xiao Yu, Raj Makkar, James McCabe, Molly Szerlip, Samir Kapadia, Mark Russo, S. Chris Malaisrie, John G. Webb, Wilson Y. Szeto, Susheel Kodali, Vinod H. Thourani, Michael J. Mack, Martin B. Leon

^*Corresponding author for this work

Surgery, Cardiac Surgery Division

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

13 Scopus citations

Abstract

Background: The potential advantages for conscious sedation (CS) as compared to general anesthesia (GA) have not been evaluated in studies with core laboratory echocardiographic assessments and monitored end points. We compared CS versus GA for SAPIEN 3 transcatheter aortic valve replacement in patients at intermediate-and low-surgical risk. Methods: This analysis included patients in the PARTNER 2 (Placement of Aortic Transcatheter Valve Trial) intermediate-risk registry and the PARTNER 3 randomized low-risk study. CS was compared to GA with respect to death, stroke, bleeding, paravalvular regurgitation, length of stay, and costs. Outcomes were assessed by a core echocardiographic laboratory, and clinical events were independently adjudicated. Results: Baseline characteristics were similar between the CS and GA groups. Postprocedure hospital length of stay was significantly shorter for CS versus GA both in intermediate-risk patients (4.4±0.2 and 5.2±0.2 days, respectively, P<0.01) and low-risk patients (2.7±0.1 and 3.4±0.2 days, respectively, P<0.001). There were no significant differences between CA and GA patients in either the 30-day or 1-year rates of death, stroke, rehospitalization, or paravalvular aortic regurgitation ≥moderate. In the intermediate-risk cohort, adjusted 30-day health care costs were $3833 lower per patient in the CS group. Conclusions: The selective use of CS is associated with shorter procedure times, shorter intensive care unit and hospital length of stay, lower costs, and no difference in clinical outcomes to 1 year, including ≥moderate paravalvular regurgitation. Our data demonstrate similar safety profiles with both approaches and support the continued use of CS for most patients undergoing the procedure. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03222128 and NCT02675114.

Original language	English (US)
Pages (from-to)	E010310
Journal	Circulation: Cardiovascular Interventions
Volume	14
Issue number	7
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.120.010310
State	Published - Jul 1 2021

Funding

Dr Herrmann reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and consulting fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Cohen reports research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and consulting fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Hahn reports consulting fees/speaker honoraria from Abbott, Boston Scientific, Bayliss, Edwards Lifesciences, Philips Healthcare, Siemens Healthineers, 3Men-sio, Gore & Associates, Medtronic, and Navigate and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Babaliaros reports institutional research funding from Abbott, Edwards Lifesciences, and Medtronic, consulting fees from Edwards Lifesciences, and equity in Transmural Systems. Dr Yu is an employee of Edwards Lifesciences. Dr Kodali reports institutional research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; consulting fees from Abbott, Admedus, and Meril Life Sciences; and equity in Biotrace Medical, Thubri-kar Aortic Valve Inc, and Dura Biotech. Dr Kapadia reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Szerlip reports consulting fees from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Thourani reports research funding from Edwards Lifesciences. Dr Mack reports institutional research funding from Edwards Lifesciences, consulting fees from Gore, and nonfinancial relationships with Edwards Lifesciences, Medtronic, and Abbott. Dr Leon reports institutional research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and consulting fees from Medtronic, Boston Scientific, Gore Medical, Meril Life Sciences, and Abbott. The other authors report no conflicts. Supported by Edwards Lifesciences.

Keywords

anesthesia, general
conscious sedation
echocardiography
length of stay
transcatheter aortic valve replacement

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1161/CIRCINTERVENTIONS.120.010310

Cite this

Herrmann, H. C., Cohen, D. J., Hahn, R. T., Babaliaros, V. C., Yu, X., Makkar, R., McCabe, J., Szerlip, M., Kapadia, S., Russo, M., Malaisrie, S. C., Webb, J. G., Szeto, W. Y., Kodali, S., Thourani, V. H., Mack, M. J., & Leon, M. B. (2021). Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement. Circulation: Cardiovascular Interventions, 14(7), E010310. https://doi.org/10.1161/CIRCINTERVENTIONS.120.010310

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abstract = "Background: The potential advantages for conscious sedation (CS) as compared to general anesthesia (GA) have not been evaluated in studies with core laboratory echocardiographic assessments and monitored end points. We compared CS versus GA for SAPIEN 3 transcatheter aortic valve replacement in patients at intermediate-and low-surgical risk. Methods: This analysis included patients in the PARTNER 2 (Placement of Aortic Transcatheter Valve Trial) intermediate-risk registry and the PARTNER 3 randomized low-risk study. CS was compared to GA with respect to death, stroke, bleeding, paravalvular regurgitation, length of stay, and costs. Outcomes were assessed by a core echocardiographic laboratory, and clinical events were independently adjudicated. Results: Baseline characteristics were similar between the CS and GA groups. Postprocedure hospital length of stay was significantly shorter for CS versus GA both in intermediate-risk patients (4.4±0.2 and 5.2±0.2 days, respectively, P<0.01) and low-risk patients (2.7±0.1 and 3.4±0.2 days, respectively, P<0.001). There were no significant differences between CA and GA patients in either the 30-day or 1-year rates of death, stroke, rehospitalization, or paravalvular aortic regurgitation ≥moderate. In the intermediate-risk cohort, adjusted 30-day health care costs were $3833 lower per patient in the CS group. Conclusions: The selective use of CS is associated with shorter procedure times, shorter intensive care unit and hospital length of stay, lower costs, and no difference in clinical outcomes to 1 year, including ≥moderate paravalvular regurgitation. Our data demonstrate similar safety profiles with both approaches and support the continued use of CS for most patients undergoing the procedure. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03222128 and NCT02675114.",

keywords = "anesthesia, general, conscious sedation, echocardiography, length of stay, transcatheter aortic valve replacement",

author = "Herrmann, {Howard C.} and Cohen, {David J.} and Hahn, {Rebecca T.} and Babaliaros, {Vasilis C.} and Xiao Yu and Raj Makkar and James McCabe and Molly Szerlip and Samir Kapadia and Mark Russo and Malaisrie, {S. Chris} and Webb, {John G.} and Szeto, {Wilson Y.} and Susheel Kodali and Thourani, {Vinod H.} and Mack, {Michael J.} and Leon, {Martin B.}",

note = "Funding Information: Dr Herrmann reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and consulting fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Cohen reports research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and consulting fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Hahn reports consulting fees/speaker honoraria from Abbott, Boston Scientific, Bayliss, Edwards Lifesciences, Philips Healthcare, Siemens Healthineers, 3Men-sio, Gore & Associates, Medtronic, and Navigate and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Babaliaros reports institutional research funding from Abbott, Edwards Lifesciences, and Medtronic, consulting fees from Edwards Lifesciences, and equity in Transmural Systems. Dr Yu is an employee of Edwards Lifesciences. Dr Kodali reports institutional research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; consulting fees from Abbott, Admedus, and Meril Life Sciences; and equity in Biotrace Medical, Thubri-kar Aortic Valve Inc, and Dura Biotech. Dr Kapadia reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Szerlip reports consulting fees from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Thourani reports research funding from Edwards Lifesciences. Dr Mack reports institutional research funding from Edwards Lifesciences, consulting fees from Gore, and nonfinancial relationships with Edwards Lifesciences, Medtronic, and Abbott. Dr Leon reports institutional research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and consulting fees from Medtronic, Boston Scientific, Gore Medical, Meril Life Sciences, and Abbott. The other authors report no conflicts. Funding Information: Supported by Edwards Lifesciences. Publisher Copyright: {\textcopyright} 2021 Lippincott Williams and Wilkins. All rights reserved.",

year = "2021",

month = jul,

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doi = "10.1161/CIRCINTERVENTIONS.120.010310",

language = "English (US)",

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Herrmann, HC, Cohen, DJ, Hahn, RT, Babaliaros, VC, Yu, X, Makkar, R, McCabe, J, Szerlip, M, Kapadia, S, Russo, M, Malaisrie, SC, Webb, JG, Szeto, WY, Kodali, S, Thourani, VH, Mack, MJ & Leon, MB 2021, 'Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement', Circulation: Cardiovascular Interventions, vol. 14, no. 7, pp. E010310. https://doi.org/10.1161/CIRCINTERVENTIONS.120.010310

TY - JOUR

T1 - Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement

AU - Herrmann, Howard C.

AU - Cohen, David J.

AU - Hahn, Rebecca T.

AU - Babaliaros, Vasilis C.

AU - Yu, Xiao

AU - Makkar, Raj

AU - McCabe, James

AU - Szerlip, Molly

AU - Kapadia, Samir

AU - Russo, Mark

AU - Malaisrie, S. Chris

AU - Webb, John G.

AU - Szeto, Wilson Y.

AU - Kodali, Susheel

AU - Thourani, Vinod H.

AU - Mack, Michael J.

AU - Leon, Martin B.

N1 - Funding Information: Dr Herrmann reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic and consulting fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Cohen reports research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and consulting fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Hahn reports consulting fees/speaker honoraria from Abbott, Boston Scientific, Bayliss, Edwards Lifesciences, Philips Healthcare, Siemens Healthineers, 3Men-sio, Gore & Associates, Medtronic, and Navigate and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Babaliaros reports institutional research funding from Abbott, Edwards Lifesciences, and Medtronic, consulting fees from Edwards Lifesciences, and equity in Transmural Systems. Dr Yu is an employee of Edwards Lifesciences. Dr Kodali reports institutional research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; consulting fees from Abbott, Admedus, and Meril Life Sciences; and equity in Biotrace Medical, Thubri-kar Aortic Valve Inc, and Dura Biotech. Dr Kapadia reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Szerlip reports consulting fees from Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Thourani reports research funding from Edwards Lifesciences. Dr Mack reports institutional research funding from Edwards Lifesciences, consulting fees from Gore, and nonfinancial relationships with Edwards Lifesciences, Medtronic, and Abbott. Dr Leon reports institutional research funding from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and consulting fees from Medtronic, Boston Scientific, Gore Medical, Meril Life Sciences, and Abbott. The other authors report no conflicts. Funding Information: Supported by Edwards Lifesciences. Publisher Copyright: © 2021 Lippincott Williams and Wilkins. All rights reserved.

PY - 2021/7/1

Y1 - 2021/7/1

N2 - Background: The potential advantages for conscious sedation (CS) as compared to general anesthesia (GA) have not been evaluated in studies with core laboratory echocardiographic assessments and monitored end points. We compared CS versus GA for SAPIEN 3 transcatheter aortic valve replacement in patients at intermediate-and low-surgical risk. Methods: This analysis included patients in the PARTNER 2 (Placement of Aortic Transcatheter Valve Trial) intermediate-risk registry and the PARTNER 3 randomized low-risk study. CS was compared to GA with respect to death, stroke, bleeding, paravalvular regurgitation, length of stay, and costs. Outcomes were assessed by a core echocardiographic laboratory, and clinical events were independently adjudicated. Results: Baseline characteristics were similar between the CS and GA groups. Postprocedure hospital length of stay was significantly shorter for CS versus GA both in intermediate-risk patients (4.4±0.2 and 5.2±0.2 days, respectively, P<0.01) and low-risk patients (2.7±0.1 and 3.4±0.2 days, respectively, P<0.001). There were no significant differences between CA and GA patients in either the 30-day or 1-year rates of death, stroke, rehospitalization, or paravalvular aortic regurgitation ≥moderate. In the intermediate-risk cohort, adjusted 30-day health care costs were $3833 lower per patient in the CS group. Conclusions: The selective use of CS is associated with shorter procedure times, shorter intensive care unit and hospital length of stay, lower costs, and no difference in clinical outcomes to 1 year, including ≥moderate paravalvular regurgitation. Our data demonstrate similar safety profiles with both approaches and support the continued use of CS for most patients undergoing the procedure. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03222128 and NCT02675114.

AB - Background: The potential advantages for conscious sedation (CS) as compared to general anesthesia (GA) have not been evaluated in studies with core laboratory echocardiographic assessments and monitored end points. We compared CS versus GA for SAPIEN 3 transcatheter aortic valve replacement in patients at intermediate-and low-surgical risk. Methods: This analysis included patients in the PARTNER 2 (Placement of Aortic Transcatheter Valve Trial) intermediate-risk registry and the PARTNER 3 randomized low-risk study. CS was compared to GA with respect to death, stroke, bleeding, paravalvular regurgitation, length of stay, and costs. Outcomes were assessed by a core echocardiographic laboratory, and clinical events were independently adjudicated. Results: Baseline characteristics were similar between the CS and GA groups. Postprocedure hospital length of stay was significantly shorter for CS versus GA both in intermediate-risk patients (4.4±0.2 and 5.2±0.2 days, respectively, P<0.01) and low-risk patients (2.7±0.1 and 3.4±0.2 days, respectively, P<0.001). There were no significant differences between CA and GA patients in either the 30-day or 1-year rates of death, stroke, rehospitalization, or paravalvular aortic regurgitation ≥moderate. In the intermediate-risk cohort, adjusted 30-day health care costs were $3833 lower per patient in the CS group. Conclusions: The selective use of CS is associated with shorter procedure times, shorter intensive care unit and hospital length of stay, lower costs, and no difference in clinical outcomes to 1 year, including ≥moderate paravalvular regurgitation. Our data demonstrate similar safety profiles with both approaches and support the continued use of CS for most patients undergoing the procedure. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03222128 and NCT02675114.

KW - anesthesia, general

KW - conscious sedation

KW - echocardiography

KW - length of stay

KW - transcatheter aortic valve replacement

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JO - Circulation: Cardiovascular Interventions

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ER -

Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement

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