Safety and feasibility of hemodynamic pulmonary artery pressure monitoring using the CardioMEMS device in LVAD management

Jesse F. Veenis; Sumant P. Radhoe; Nicolas M. van Mieghem; Olivier C. Manintveld; Jos A. Bekkers; Kadir Caliskan; Ad J.J.C. Bogers; Felix Zijlstra; Jasper J. Brugts

doi:10.1111/jocs.15767

Safety and feasibility of hemodynamic pulmonary artery pressure monitoring using the CardioMEMS device in LVAD management

Jesse F. Veenis, Sumant P. Radhoe, Nicolas M. van Mieghem, Olivier C. Manintveld, Jos A. Bekkers, Kadir Caliskan, Ad J.J.C. Bogers, Felix Zijlstra, Jasper J. Brugts^*

^*Corresponding author for this work

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

5 Citations (Scopus)

Abstract

Background: There is a clinical need for additional remote tools to improve left ventricular assist device (LVAD) patient management. The aim of this pilot concept study was to assess the safety and feasibility of optimizing patient management with add-on remote hemodynamic monitoring using the CardioMEMS in LVAD patients during different treatment stages. Methods: Ten consecutive patients accepted and clinically ready for (semi-) elective HeartMate 3 LVAD surgery were included. All patients received a CardioMEMS to optimize filling pressure before surgery. Patients were categorized into those with normal mean pulmonary artery pressure (mPAP) (≤25 mmHg, n = 4) or elevated mPAP (>25 mmHg, n = 6), and compared to a historical cohort (n = 20). Endpoints were CardioMEMS device safety and a combined endpoint of all-cause mortality, acute kidney injury, renal replacement therapy and/or right ventricular failure at 1-year follow-up. Additionally, we investigated hospital-free survival and improvement in quality of life (QoL) and exercise tolerance. Results: No safety issues or signal interferences were observed. The combined endpoint occurred in 60% of historical controls, 0% in normal and 83% in elevated mPAP group. Post-discharge, the hospital-free survival was significantly better, and the QoL improved more in the normal compared to the elevated mPAP group. Conclusion: Remote hemodynamic monitoring in LVAD patients is safe and feasible with the CardioMEMS, which could be used to identify patients at elevated risk of complications as well as optimize patient management remotely during the out-patient phase with less frequent hospitalizations. Larger pivotal studies are warranted to test the hypothesis generated from this concept study.

Original language	English
Pages (from-to)	3271-3280
Number of pages	10
Journal	Journal of Cardiac Surgery
Volume	36
Issue number	9
DOIs	https://doi.org/10.1111/jocs.15767
Publication status	Published - 1 Sep 2021

Bibliographical note

Funding Information:
The authors greatly acknowledge the participation of LVAD nurse practitioners of the Erasmus MC, University Medical Center Rotterdam, Thorax Center, Rotterdam, the Netherlands. This study was supported by Abbott with an independent research grant, partially covering personnel costs. This study was investigator-initiated and was designed, conducted, interpreted and reported by the CRO/sponsor Erasmus University Medical Center independently of the funder.

Funding Information:
The authors greatly acknowledge the participation of LVAD nurse practitioners of the Erasmus MC, University Medical Center Rotterdam, Thorax Center, Rotterdam, the Netherlands. This study was supported by Abbott with an independent research grant, partially covering personnel costs. This study was investigator‐initiated and was designed, conducted, interpreted and reported by the CRO/sponsor Erasmus University Medical Center independently of the funder.

Publisher Copyright:
© 2021 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC

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@article{e6f66aaae35c4f49881db48cbc65ced0,

title = "Safety and feasibility of hemodynamic pulmonary artery pressure monitoring using the CardioMEMS device in LVAD management",

abstract = "Background: There is a clinical need for additional remote tools to improve left ventricular assist device (LVAD) patient management. The aim of this pilot concept study was to assess the safety and feasibility of optimizing patient management with add-on remote hemodynamic monitoring using the CardioMEMS in LVAD patients during different treatment stages. Methods: Ten consecutive patients accepted and clinically ready for (semi-) elective HeartMate 3 LVAD surgery were included. All patients received a CardioMEMS to optimize filling pressure before surgery. Patients were categorized into those with normal mean pulmonary artery pressure (mPAP) (≤25 mmHg, n = 4) or elevated mPAP (>25 mmHg, n = 6), and compared to a historical cohort (n = 20). Endpoints were CardioMEMS device safety and a combined endpoint of all-cause mortality, acute kidney injury, renal replacement therapy and/or right ventricular failure at 1-year follow-up. Additionally, we investigated hospital-free survival and improvement in quality of life (QoL) and exercise tolerance. Results: No safety issues or signal interferences were observed. The combined endpoint occurred in 60% of historical controls, 0% in normal and 83% in elevated mPAP group. Post-discharge, the hospital-free survival was significantly better, and the QoL improved more in the normal compared to the elevated mPAP group. Conclusion: Remote hemodynamic monitoring in LVAD patients is safe and feasible with the CardioMEMS, which could be used to identify patients at elevated risk of complications as well as optimize patient management remotely during the out-patient phase with less frequent hospitalizations. Larger pivotal studies are warranted to test the hypothesis generated from this concept study.",

author = "Veenis, {Jesse F.} and Radhoe, {Sumant P.} and {van Mieghem}, {Nicolas M.} and Manintveld, {Olivier C.} and Bekkers, {Jos A.} and Kadir Caliskan and Bogers, {Ad J.J.C.} and Felix Zijlstra and Brugts, {Jasper J.}",

note = "Funding Information: The authors greatly acknowledge the participation of LVAD nurse practitioners of the Erasmus MC, University Medical Center Rotterdam, Thorax Center, Rotterdam, the Netherlands. This study was supported by Abbott with an independent research grant, partially covering personnel costs. This study was investigator-initiated and was designed, conducted, interpreted and reported by the CRO/sponsor Erasmus University Medical Center independently of the funder. Funding Information: The authors greatly acknowledge the participation of LVAD nurse practitioners of the Erasmus MC, University Medical Center Rotterdam, Thorax Center, Rotterdam, the Netherlands. This study was supported by Abbott with an independent research grant, partially covering personnel costs. This study was investigator‐initiated and was designed, conducted, interpreted and reported by the CRO/sponsor Erasmus University Medical Center independently of the funder. Publisher Copyright: {\textcopyright} 2021 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC",

year = "2021",

month = sep,

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doi = "10.1111/jocs.15767",

language = "English",

volume = "36",

pages = "3271--3280",

journal = "Journal of Cardiac Surgery",

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T1 - Safety and feasibility of hemodynamic pulmonary artery pressure monitoring using the CardioMEMS device in LVAD management

AU - Veenis, Jesse F.

AU - Radhoe, Sumant P.

AU - van Mieghem, Nicolas M.

AU - Manintveld, Olivier C.

AU - Bekkers, Jos A.

AU - Caliskan, Kadir

AU - Bogers, Ad J.J.C.

AU - Zijlstra, Felix

AU - Brugts, Jasper J.

N1 - Funding Information: The authors greatly acknowledge the participation of LVAD nurse practitioners of the Erasmus MC, University Medical Center Rotterdam, Thorax Center, Rotterdam, the Netherlands. This study was supported by Abbott with an independent research grant, partially covering personnel costs. This study was investigator-initiated and was designed, conducted, interpreted and reported by the CRO/sponsor Erasmus University Medical Center independently of the funder. Funding Information: The authors greatly acknowledge the participation of LVAD nurse practitioners of the Erasmus MC, University Medical Center Rotterdam, Thorax Center, Rotterdam, the Netherlands. This study was supported by Abbott with an independent research grant, partially covering personnel costs. This study was investigator‐initiated and was designed, conducted, interpreted and reported by the CRO/sponsor Erasmus University Medical Center independently of the funder. Publisher Copyright: © 2021 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC

PY - 2021/9/1

Y1 - 2021/9/1

N2 - Background: There is a clinical need for additional remote tools to improve left ventricular assist device (LVAD) patient management. The aim of this pilot concept study was to assess the safety and feasibility of optimizing patient management with add-on remote hemodynamic monitoring using the CardioMEMS in LVAD patients during different treatment stages. Methods: Ten consecutive patients accepted and clinically ready for (semi-) elective HeartMate 3 LVAD surgery were included. All patients received a CardioMEMS to optimize filling pressure before surgery. Patients were categorized into those with normal mean pulmonary artery pressure (mPAP) (≤25 mmHg, n = 4) or elevated mPAP (>25 mmHg, n = 6), and compared to a historical cohort (n = 20). Endpoints were CardioMEMS device safety and a combined endpoint of all-cause mortality, acute kidney injury, renal replacement therapy and/or right ventricular failure at 1-year follow-up. Additionally, we investigated hospital-free survival and improvement in quality of life (QoL) and exercise tolerance. Results: No safety issues or signal interferences were observed. The combined endpoint occurred in 60% of historical controls, 0% in normal and 83% in elevated mPAP group. Post-discharge, the hospital-free survival was significantly better, and the QoL improved more in the normal compared to the elevated mPAP group. Conclusion: Remote hemodynamic monitoring in LVAD patients is safe and feasible with the CardioMEMS, which could be used to identify patients at elevated risk of complications as well as optimize patient management remotely during the out-patient phase with less frequent hospitalizations. Larger pivotal studies are warranted to test the hypothesis generated from this concept study.

AB - Background: There is a clinical need for additional remote tools to improve left ventricular assist device (LVAD) patient management. The aim of this pilot concept study was to assess the safety and feasibility of optimizing patient management with add-on remote hemodynamic monitoring using the CardioMEMS in LVAD patients during different treatment stages. Methods: Ten consecutive patients accepted and clinically ready for (semi-) elective HeartMate 3 LVAD surgery were included. All patients received a CardioMEMS to optimize filling pressure before surgery. Patients were categorized into those with normal mean pulmonary artery pressure (mPAP) (≤25 mmHg, n = 4) or elevated mPAP (>25 mmHg, n = 6), and compared to a historical cohort (n = 20). Endpoints were CardioMEMS device safety and a combined endpoint of all-cause mortality, acute kidney injury, renal replacement therapy and/or right ventricular failure at 1-year follow-up. Additionally, we investigated hospital-free survival and improvement in quality of life (QoL) and exercise tolerance. Results: No safety issues or signal interferences were observed. The combined endpoint occurred in 60% of historical controls, 0% in normal and 83% in elevated mPAP group. Post-discharge, the hospital-free survival was significantly better, and the QoL improved more in the normal compared to the elevated mPAP group. Conclusion: Remote hemodynamic monitoring in LVAD patients is safe and feasible with the CardioMEMS, which could be used to identify patients at elevated risk of complications as well as optimize patient management remotely during the out-patient phase with less frequent hospitalizations. Larger pivotal studies are warranted to test the hypothesis generated from this concept study.

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Safety and feasibility of hemodynamic pulmonary artery pressure monitoring using the CardioMEMS device in LVAD management

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