Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD)

Kiran K Mirza; Mariusz K Szymanski; Thomas Schmidt; Nicolaas de Jonge; Darshan H Brahmbhatt; Filio Billia; Steven Hsu; Guy A MacGowan; Djordje G Jakovljevic; Piergiuseppe Agostoni; Filippo Trombara; Ulrich Jorde; Yogita Rochlani; Katrien Vandersmissen; Nils Reiss; Stuart D Russell; Bart Meyns; Finn Gustafsson; PRO-VAD investigators

doi:10.1016/j.jchf.2021.05.021

Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD)

Kiran K Mirza, Mariusz K Szymanski, Thomas Schmidt, Nicolaas de Jonge, Darshan H Brahmbhatt, Filio Billia, Steven Hsu, Guy A MacGowan, Djordje G Jakovljevic, Piergiuseppe Agostoni, Filippo Trombara, Ulrich Jorde, Yogita Rochlani, Katrien Vandersmissen, Nils Reiss, Stuart D Russell, Bart Meyns, Finn Gustafsson, PRO-VAD investigators

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Abstract

OBJECTIVES: The purpose of this study was to examine whether peak oxygen uptake (pVO2) and other cardiopulmonary exercise test (CPET)-derived variables could predict intermediate-term mortality in stable continuous flow LVAD recipients.

BACKGROUND: pVO2 is a cornerstone in the selection of patients for heart transplantation, but the prognostic power of pVO2 obtained in patients treated with a left ventricular assist device (LVAD) is unknown.

METHODS: We collected data for pVO2 and outcomes in adult LVAD recipients in a retrospective, multicenter study and evaluated cutoff values for pVO2 including: 1) values above or below medians; 2) grouping patients in tertiles; and 3) pVO2 ≤14 ml/kg/min if the patient was not treated with beta-blockers (BB) or pVO2 ≤12 ml/kg/min if the patient was taking BB therapy.

RESULTS: Nine centers contributed data from 450 patients. Patients were 53 ± 13 years of age; 78% were male; body mass index was 25 ± 5 kg/m2 with few comorbidities (stroke: 11%; diabetes: 18%; and peripheral artery disease: 4%). The cause of heart failure (HF) was most often nonischemic (66%). Devices included were the HeartMate II and 3 (Abbott); and Heartware ventricular assist devices Jarvik and Duraheart (Medtronic). The index CPET was performed at a median of 189 days (154 days-225 days) after LVAD implantation, and mean pVO2 was 14.1 ± 5 ml/kg/min (47% ± 14% of predicted value). Lower pVO2 values were strongly associated with poorer survival regardless of whether patients were analyzed for absolute pVO2 in ml/kg/min, pVO2 ≤12 BB/14 ml/kg/min, or as a percentage of predicted pVO2 values (P ≤ 0.001 for all). For patients with pVO2 >12 BB/14 and ventilation/carbon dioxide relationship (VE/VCO2) slope <35, the 1-year survival was 100%.

CONCLUSIONS: Even after LVAD implantation, pVO2 has prognostic value, similar to HF patients not supported by mechanical circulatory support devices. (PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake [pVO2] in Recipients of Left Ventricular Assist Devices [PRO-VAD]; NCT04423562).

Original language	English
Pages (from-to)	758-767
Number of pages	10
Journal	JACC. Heart failure
Volume	9
Issue number	10
Early online date	11 Aug 2021
DOIs	https://doi.org/10.1016/j.jchf.2021.05.021
Publication status	Published - Oct 2021

Bibliographical note

© 2021, Elsevier. Licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/

Copyright © and Moral Rights are retained by the author(s) and/ or other copyright owners. A copy can be downloaded for personal non-commercial research or study, without prior permission or charge. This item cannot be reproduced or quoted extensively from without first obtaining permission in writing from the copyright holder(s). The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the copyright holders.

Funder

Dr Mirza received Danish funding from Skibsreder Per Henriksen, R og hustrus Fond grant 10403/53 and Jascha Fonden grants 6186 and 7724. Dr Gustafsson is supported by research grant NNF20OC006056 from the Novo Nordisk Foundation. Dr Brahmbhatt has received travel support from Abbott, Biotronik; and has received honoraria, travel support, and research funding from Boston Scientific (all outside the submitted work). Dr Hsu has received U.S. National Institutes of Health funding (grant K23-HL146889) (all outside the submitted work). Dr MacGowan is supported by EU Horizon 2020 and United Kingdom National Institute of Health Research. Dr Jakovljevic is supported by EU Horizon 2020 Research and Innovation Programme under grant agreements 777204 and 952603

Funding

Dr Mirza received Danish funding from Skibsreder Per Henriksen, R og hustrus Fond grant 10403/53 and Jascha Fonden grants 6186 and 7724. Dr Gustafsson is supported by research grant NNF20OC006056 from the Novo Nordisk Foundation. [...] Dr MacGowan is supported by EU Horizon 2020 and United Kingdom National Institute of Health Research. Dr Jakovljevic is supported by EU Horizon 2020 Research and Innovation Programme under grant agreements 777204 and 952603.

Funders	Funder number
Skibsreder Per Henriksen, R og hustrus Fond	10403/53
Jascha Fonden	6186, 7724
National Institute for Health and Care Research
European Horizon 2020	777204, 952603
Novo Nordisk Fonden	NNF20OC006056

Keywords

excercise
maximum oxygen uptake
outcome
prognosis
survival
exercise

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.jchf.2021.05.021

Post-PrintAccepted author manuscript, 1.64 MBLicence: CC BY-NC-ND

Cite this

Mirza, K. K., Szymanski, M. K., Schmidt, T., de Jonge, N., Brahmbhatt, D. H., Billia, F., Hsu, S., MacGowan, G. A., Jakovljevic, D. G., Agostoni, P., Trombara, F., Jorde, U., Rochlani, Y., Vandersmissen, K., Reiss, N., Russell, S. D., Meyns, B., Gustafsson, F., & PRO-VAD investigators (2021). Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD). JACC. Heart failure, 9(10), 758-767. https://doi.org/10.1016/j.jchf.2021.05.021

Mirza, KK, Szymanski, MK, Schmidt, T, de Jonge, N, Brahmbhatt, DH, Billia, F, Hsu, S, MacGowan, GA, Jakovljevic, DG, Agostoni, P, Trombara, F, Jorde, U, Rochlani, Y, Vandersmissen, K, Reiss, N, Russell, SD, Meyns, B, Gustafsson, F & PRO-VAD investigators 2021, 'Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD)', JACC. Heart failure, vol. 9, no. 10, pp. 758-767. https://doi.org/10.1016/j.jchf.2021.05.021

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title = "Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD)",

abstract = "OBJECTIVES: The purpose of this study was to examine whether peak oxygen uptake (pVO2) and other cardiopulmonary exercise test (CPET)-derived variables could predict intermediate-term mortality in stable continuous flow LVAD recipients.BACKGROUND: pVO2 is a cornerstone in the selection of patients for heart transplantation, but the prognostic power of pVO2 obtained in patients treated with a left ventricular assist device (LVAD) is unknown.METHODS: We collected data for pVO2 and outcomes in adult LVAD recipients in a retrospective, multicenter study and evaluated cutoff values for pVO2 including: 1) values above or below medians; 2) grouping patients in tertiles; and 3) pVO2 ≤14 ml/kg/min if the patient was not treated with beta-blockers (BB) or pVO2 ≤12 ml/kg/min if the patient was taking BB therapy.RESULTS: Nine centers contributed data from 450 patients. Patients were 53 ± 13 years of age; 78% were male; body mass index was 25 ± 5 kg/m2 with few comorbidities (stroke: 11%; diabetes: 18%; and peripheral artery disease: 4%). The cause of heart failure (HF) was most often nonischemic (66%). Devices included were the HeartMate II and 3 (Abbott); and Heartware ventricular assist devices Jarvik and Duraheart (Medtronic). The index CPET was performed at a median of 189 days (154 days-225 days) after LVAD implantation, and mean pVO2 was 14.1 ± 5 ml/kg/min (47% ± 14% of predicted value). Lower pVO2 values were strongly associated with poorer survival regardless of whether patients were analyzed for absolute pVO2 in ml/kg/min, pVO2 ≤12 BB/14 ml/kg/min, or as a percentage of predicted pVO2 values (P ≤ 0.001 for all). For patients with pVO2 >12 BB/14 and ventilation/carbon dioxide relationship (VE/VCO2) slope <35, the 1-year survival was 100%.CONCLUSIONS: Even after LVAD implantation, pVO2 has prognostic value, similar to HF patients not supported by mechanical circulatory support devices. (PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake [pVO2] in Recipients of Left Ventricular Assist Devices [PRO-VAD]; NCT04423562).",

keywords = "excercise, maximum oxygen uptake, outcome, prognosis, survival, exercise",

author = "Mirza, {Kiran K} and Szymanski, {Mariusz K} and Thomas Schmidt and {de Jonge}, Nicolaas and Brahmbhatt, {Darshan H} and Filio Billia and Steven Hsu and MacGowan, {Guy A} and Jakovljevic, {Djordje G} and Piergiuseppe Agostoni and Filippo Trombara and Ulrich Jorde and Yogita Rochlani and Katrien Vandersmissen and Nils Reiss and Russell, {Stuart D} and Bart Meyns and Finn Gustafsson and {PRO-VAD investigators}",

note = "{\textcopyright} 2021, Elsevier. Licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ Copyright {\textcopyright} and Moral Rights are retained by the author(s) and/ or other copyright owners. A copy can be downloaded for personal non-commercial research or study, without prior permission or charge. This item cannot be reproduced or quoted extensively from without first obtaining permission in writing from the copyright holder(s). The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the copyright holders. ",

year = "2021",

month = oct,

doi = "10.1016/j.jchf.2021.05.021",

language = "English",

volume = "9",

pages = "758--767",

journal = "JACC. Heart failure",

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TY - JOUR

T1 - Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD)

AU - Mirza, Kiran K

AU - Szymanski, Mariusz K

AU - Schmidt, Thomas

AU - de Jonge, Nicolaas

AU - Brahmbhatt, Darshan H

AU - Billia, Filio

AU - Hsu, Steven

AU - MacGowan, Guy A

AU - Jakovljevic, Djordje G

AU - Agostoni, Piergiuseppe

AU - Trombara, Filippo

AU - Jorde, Ulrich

AU - Rochlani, Yogita

AU - Vandersmissen, Katrien

AU - Reiss, Nils

AU - Russell, Stuart D

AU - Meyns, Bart

AU - Gustafsson, Finn

AU - PRO-VAD investigators

N1 - © 2021, Elsevier. Licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ Copyright © and Moral Rights are retained by the author(s) and/ or other copyright owners. A copy can be downloaded for personal non-commercial research or study, without prior permission or charge. This item cannot be reproduced or quoted extensively from without first obtaining permission in writing from the copyright holder(s). The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the copyright holders.

PY - 2021/10

Y1 - 2021/10

N2 - OBJECTIVES: The purpose of this study was to examine whether peak oxygen uptake (pVO2) and other cardiopulmonary exercise test (CPET)-derived variables could predict intermediate-term mortality in stable continuous flow LVAD recipients.BACKGROUND: pVO2 is a cornerstone in the selection of patients for heart transplantation, but the prognostic power of pVO2 obtained in patients treated with a left ventricular assist device (LVAD) is unknown.METHODS: We collected data for pVO2 and outcomes in adult LVAD recipients in a retrospective, multicenter study and evaluated cutoff values for pVO2 including: 1) values above or below medians; 2) grouping patients in tertiles; and 3) pVO2 ≤14 ml/kg/min if the patient was not treated with beta-blockers (BB) or pVO2 ≤12 ml/kg/min if the patient was taking BB therapy.RESULTS: Nine centers contributed data from 450 patients. Patients were 53 ± 13 years of age; 78% were male; body mass index was 25 ± 5 kg/m2 with few comorbidities (stroke: 11%; diabetes: 18%; and peripheral artery disease: 4%). The cause of heart failure (HF) was most often nonischemic (66%). Devices included were the HeartMate II and 3 (Abbott); and Heartware ventricular assist devices Jarvik and Duraheart (Medtronic). The index CPET was performed at a median of 189 days (154 days-225 days) after LVAD implantation, and mean pVO2 was 14.1 ± 5 ml/kg/min (47% ± 14% of predicted value). Lower pVO2 values were strongly associated with poorer survival regardless of whether patients were analyzed for absolute pVO2 in ml/kg/min, pVO2 ≤12 BB/14 ml/kg/min, or as a percentage of predicted pVO2 values (P ≤ 0.001 for all). For patients with pVO2 >12 BB/14 and ventilation/carbon dioxide relationship (VE/VCO2) slope <35, the 1-year survival was 100%.CONCLUSIONS: Even after LVAD implantation, pVO2 has prognostic value, similar to HF patients not supported by mechanical circulatory support devices. (PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake [pVO2] in Recipients of Left Ventricular Assist Devices [PRO-VAD]; NCT04423562).

AB - OBJECTIVES: The purpose of this study was to examine whether peak oxygen uptake (pVO2) and other cardiopulmonary exercise test (CPET)-derived variables could predict intermediate-term mortality in stable continuous flow LVAD recipients.BACKGROUND: pVO2 is a cornerstone in the selection of patients for heart transplantation, but the prognostic power of pVO2 obtained in patients treated with a left ventricular assist device (LVAD) is unknown.METHODS: We collected data for pVO2 and outcomes in adult LVAD recipients in a retrospective, multicenter study and evaluated cutoff values for pVO2 including: 1) values above or below medians; 2) grouping patients in tertiles; and 3) pVO2 ≤14 ml/kg/min if the patient was not treated with beta-blockers (BB) or pVO2 ≤12 ml/kg/min if the patient was taking BB therapy.RESULTS: Nine centers contributed data from 450 patients. Patients were 53 ± 13 years of age; 78% were male; body mass index was 25 ± 5 kg/m2 with few comorbidities (stroke: 11%; diabetes: 18%; and peripheral artery disease: 4%). The cause of heart failure (HF) was most often nonischemic (66%). Devices included were the HeartMate II and 3 (Abbott); and Heartware ventricular assist devices Jarvik and Duraheart (Medtronic). The index CPET was performed at a median of 189 days (154 days-225 days) after LVAD implantation, and mean pVO2 was 14.1 ± 5 ml/kg/min (47% ± 14% of predicted value). Lower pVO2 values were strongly associated with poorer survival regardless of whether patients were analyzed for absolute pVO2 in ml/kg/min, pVO2 ≤12 BB/14 ml/kg/min, or as a percentage of predicted pVO2 values (P ≤ 0.001 for all). For patients with pVO2 >12 BB/14 and ventilation/carbon dioxide relationship (VE/VCO2) slope <35, the 1-year survival was 100%.CONCLUSIONS: Even after LVAD implantation, pVO2 has prognostic value, similar to HF patients not supported by mechanical circulatory support devices. (PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake [pVO2] in Recipients of Left Ventricular Assist Devices [PRO-VAD]; NCT04423562).

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KW - maximum oxygen uptake

KW - outcome

KW - prognosis

KW - survival

KW - exercise

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Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD)

Abstract

Bibliographical note

Funder

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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