Details
| Original language | English |
|---|---|
| Pages (from-to) | 238-248 |
| Number of pages | 11 |
| Journal | Seminars in Thoracic and Cardiovascular Surgery |
| Volume | 34 |
| Issue number | 1 |
| Early online date | 22 Jun 2021 |
| Publication status | Published - 1 Mar 2022 |
Abstract
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.
Keywords
- Chronic cavopulmonary assist device, Fontan, Mechanical circulatory support, Rotary blood pump
ASJC Scopus subject areas
- Medicine(all)
- Surgery
- Medicine(all)
- Pulmonary and Respiratory Medicine
- Medicine(all)
- Cardiology and Cardiovascular Medicine
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In: Seminars in Thoracic and Cardiovascular Surgery, Vol. 34, No. 1, 01.03.2022, p. 238-248.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - A Cavopulmonary Assist Device for Long-Term Therapy of Fontan Patients
AU - Escher, Andreas
AU - Strauch, Carsten
AU - Hubmann, Emanuel J.
AU - Hübler, Michael
AU - Bortis, Dominik
AU - Thamsen, Bente
AU - Mueller, Marc
AU - Kertzscher, Ulrich
AU - Thamsen, Paul U.
AU - Kolar, Johann W.
AU - Zimpfer, Daniel
AU - Granegger, Marcus
PY - 2022/3/1
Y1 - 2022/3/1
N2 - 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.
AB - 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.
KW - Chronic cavopulmonary assist device
KW - Fontan
KW - Mechanical circulatory support
KW - Rotary blood pump
UR - http://www.scopus.com/inward/record.url?scp=85111274548&partnerID=8YFLogxK
U2 - 10.1053/j.semtcvs.2021.06.016
DO - 10.1053/j.semtcvs.2021.06.016
M3 - Article
C2 - 34166811
AN - SCOPUS:85111274548
VL - 34
SP - 238
EP - 248
JO - Seminars in Thoracic and Cardiovascular Surgery
JF - Seminars in Thoracic and Cardiovascular Surgery
SN - 1043-0679
IS - 1
ER -