A Cavopulmonary Assist Device for Long-Term Therapy of Fontan Patients
Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved..
Treatment of univentricular hearts remains restricted to palliative surgical corrections (Fontan pathway). The established Fontan circulation lacks a subpulmonary pressure source and is commonly accompanied by progressively declining hemodynamics. A novel cavopulmonary assist device (CPAD) may hold the potential for improved therapeutic management of Fontan patients by chronic restoration of biventricular equivalency. This study aimed at translating clinical objectives toward a functional CPAD with preclinical proof regarding hydraulic performance, hemocompatibility and electric power consumption. A prototype composed of hemocompatible titanium components, ceramic bearings, electric motors, and corresponding drive unit was manufactured for preclinical benchtop analysis: hydraulic performance in general and hemocompatibility characteristics in particular were analyzed in-silico (computational fluid dynamics) and validated in-vitro. The CPAD's power consumption was recorded across the entire operational range. The CPAD delivered pressure step-ups across a comprehensive operational range (0-10 L/min, 0-50 mm Hg) with electric power consumption below 1.5 W within the main operating range. In-vitro hemolysis experiments (N = 3) indicated a normalized index of hemolysis of 3.8 ± 1.6 mg/100 L during design point operation (2500 rpm, 4 L/min). Preclinical investigations revealed the CPAD's potential for low traumatic and thrombogenic support of a heterogeneous Fontan population (pediatric and adult) with potentially accompanying secondary disorders (e.g., elevated pulmonary vascular resistance or systemic ventricular insufficiency) at distinct physical activities. The low power consumption implied adequate settings for a small, fully implantable system with transcutaneous energy transfer. The successful preclinical proof provides the rationale for acute and chronic in-vivo trials aiming at the confirmation of laboratory findings and verification of hemodynamic benefit.
| Errataetall: |
CommentIn: Semin Thorac Cardiovasc Surg. 2022 Spring;34(1):249-250. - PMID 34242754 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:34 |
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| Enthalten in: |
Seminars in thoracic and cardiovascular surgery - 34(2022), 1 vom: 01., Seite 238-248 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Escher, Andreas [VerfasserIn] |
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| Links: |
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| Themen: |
Chronic cavopulmonary assist device |
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| Anmerkungen: |
Date Completed 11.04.2022 Date Revised 11.04.2022 published: Print-Electronic CommentIn: Semin Thorac Cardiovasc Surg. 2022 Spring;34(1):249-250. - PMID 34242754 Citation Status MEDLINE |
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| doi: |
10.1053/j.semtcvs.2021.06.016 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a Treatment of univentricular hearts remains restricted to palliative surgical corrections (Fontan pathway). The established Fontan circulation lacks a subpulmonary pressure source and is commonly accompanied by progressively declining hemodynamics. A novel cavopulmonary assist device (CPAD) may hold the potential for improved therapeutic management of Fontan patients by chronic restoration of biventricular equivalency. This study aimed at translating clinical objectives toward a functional CPAD with preclinical proof regarding hydraulic performance, hemocompatibility and electric power consumption. A prototype composed of hemocompatible titanium components, ceramic bearings, electric motors, and corresponding drive unit was manufactured for preclinical benchtop analysis: hydraulic performance in general and hemocompatibility characteristics in particular were analyzed in-silico (computational fluid dynamics) and validated in-vitro. The CPAD's power consumption was recorded across the entire operational range. The CPAD delivered pressure step-ups across a comprehensive operational range (0-10 L/min, 0-50 mm Hg) with electric power consumption below 1.5 W within the main operating range. In-vitro hemolysis experiments (N = 3) indicated a normalized index of hemolysis of 3.8 ± 1.6 mg/100 L during design point operation (2500 rpm, 4 L/min). Preclinical investigations revealed the CPAD's potential for low traumatic and thrombogenic support of a heterogeneous Fontan population (pediatric and adult) with potentially accompanying secondary disorders (e.g., elevated pulmonary vascular resistance or systemic ventricular insufficiency) at distinct physical activities. The low power consumption implied adequate settings for a small, fully implantable system with transcutaneous energy transfer. The successful preclinical proof provides the rationale for acute and chronic in-vivo trials aiming at the confirmation of laboratory findings and verification of hemodynamic benefit | ||
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| 650 | 4 | |a Rotary blood pump | |
| 700 | 1 | |a Strauch, Carsten |e verfasserin |4 aut | |
| 700 | 1 | |a Hubmann, Emanuel J |e verfasserin |4 aut | |
| 700 | 1 | |a Hübler, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Bortis, Dominik |e verfasserin |4 aut | |
| 700 | 1 | |a Thamsen, Bente |e verfasserin |4 aut | |
| 700 | 1 | |a Mueller, Marc |e verfasserin |4 aut | |
| 700 | 1 | |a Kertzscher, Ulrich |e verfasserin |4 aut | |
| 700 | 1 | |a Thamsen, Paul U |e verfasserin |4 aut | |
| 700 | 1 | |a Kolar, Johann W |e verfasserin |4 aut | |
| 700 | 1 | |a Zimpfer, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Granegger, Marcus |e verfasserin |4 aut | |
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