Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device—The PROPER-LVAD Study

Surgeries, vol. 3, pp. 284–296

Abstract

Background: Prehabilitation is gaining increasing interest and shows promising effects on short- and long-term outcomes among patients undergoing major surgery. The effect of multimodal, interdisciplinary prehabilitation has not yet been studied in patients with severe heart failure scheduled for the implantation of a left-ventricular assist device (LVAD). Methods: This randomized controlled multi-center study evaluates the effect of preoperative combined optimization of nutritional and functional status. Patients in the intervention group are prescribed daily in-bed cycling and oral nutrition supplements (ONS) from study inclusion until the day before LVAD-implantation. Patients in the control group receive standard of care treatment. The primary outcomes for the pilot study that involves 48 patients are safety (occurrence of adverse events), efficacy (group separation regarding the intake of macronutrients), feasibility of the trial protocol (compliance (percentage of received interventions) and confirmation of recruitment rates. Secondary outcomes include longitudinal measurements of muscle mass, muscle strength, physical function and quality of life, next to traditional clinical outcomes (30-day mortality, hospital and ICU length of stay, duration of mechanical ventilation and number of complications and infections). If the pilot study is successful, a larger confirmatory, international multicenter study is warranted.

Authors 15

1. Aileen Hill corresponding Aachen Department of Anesthesiology Department of Intensive Care Medicine

   Universitätsklinikum Aachen · RWTH Aachen University

   Affiliation as printed

   Department of Anesthesiology, University Hospital RWTH Aachen, 52074 Aachen, Germany

   Department of Intensive Care Medicine, University Hospital RWTH Aachen, 52074 Aachen, Germany

2. Vera von Dossow

   Heart and Diabetes Center North Rhine-Westphalia

   Affiliation as printed

   Department of Anesthesiology and Pain Therapy, Heart and Diabetes Center NRW, 32545 Bad Oeynhausen, Germany

3. Daren Keith Heyland

   Queen's University · Clinical Evaluation Research Unit · Kingston Health Sciences Centre

   Affiliation as printed

   Clinical Evaluation Research Unit, Department of Critical Care Medicine, Kingston Health Sciences Centre, Queen’s University, Kingston, ON K7L 2V7, Canada

   Clinical Evaluation Research Unit, Department of Critical Care Medicine, Kingston Health Sciences Centre, Queen's University, Kingston, ON K7L 2V7, Canada

4. Rolf Rossaint Aachen Department of Anesthesiology

   Universitätsklinikum Aachen · RWTH Aachen University

   Affiliation as printed

   Department of Anesthesiology, University Hospital RWTH Aachen, 52074 Aachen, Germany

5. Patrick Meybohm

   University of Würzburg · Universitätsklinikum Würzburg

   Affiliation as printed

   Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, 97080 Würzburg, Germany

6. Henrik Fox

   Heart and Diabetes Center North Rhine-Westphalia · Ruhr University Bochum

   Affiliation as printed

   Heart Failure Department, Heart and Diabetes Center NRW, Ruhr-University Bochum, 32545 Bad Oeynhausen, Germany

7. Michiel Morshuis

   Heart and Diabetes Center North Rhine-Westphalia · Ruhr University Bochum

   Affiliation as printed

   Heart Failure Department, Heart and Diabetes Center NRW, Ruhr-University Bochum, 32545 Bad Oeynhausen, Germany

8. Gunnar Elke

   University Hospital Schleswig-Holstein

   Affiliation as printed

   Department of Anesthesiology, University Medical Center Schleswig-Holstein, Campus Kiel, 24105 Kiel, Germany

9. Bernd Panholzer

   University Hospital Schleswig-Holstein

   Affiliation as printed

   Department of Cardiovascular Surgery, University Medical Center Schleswig-Holstein, Campus Kiel, 24105 Kiel, Germany

10. Assad Haneya

    University Hospital Schleswig-Holstein

    Affiliation as printed

    Department of Cardiovascular Surgery, University Medical Center Schleswig-Holstein, Campus Kiel, 24105 Kiel, Germany

11. Andreas Böning

    Justus-Liebig-Universität Gießen · Universitätsklinikum Gießen und Marburg

    Affiliation as printed

    Department of Pediatric and Adult Cardiac and Vascular Surgery, University Hospital, Justus-Liebig University Giessen, 35392 Giessen, Germany

12. Bernd Niemann

    Justus-Liebig-Universität Gießen · Universitätsklinikum Gießen und Marburg

    Affiliation as printed

    Department of Pediatric and Adult Cardiac and Vascular Surgery, University Hospital, Justus-Liebig University Giessen, 35392 Giessen, Germany

13. Rashad Zayat Aachen Department of Thoracic and Cardiovascular Surgery

    Universitätsklinikum Aachen · RWTH Aachen University

    Affiliation as printed

    Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, 52074 Aachen, Germany

14. Ajay Kumar Moza Aachen Department of Thoracic and Cardiovascular Surgery

    Universitätsklinikum Aachen · RWTH Aachen University

    Affiliation as printed

    Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, 52074 Aachen, Germany

15. Christian Stoppe corresponding

    University of Würzburg · Universitätsklinikum Würzburg · Stiftung Charité · Charité - Universitätsmedizin Berlin

    Affiliation as printed

    Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, 97080 Würzburg, Germany

    Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Berlin, 10117 Berlin, Germany