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Clinical Durability of the CARMEDA BioActive Surface in EXCOR Ventricular Assist Device Pumps
Kalervo Werkkala1, Janne J Jokinen, Leena Soininen
1From the *Department of Cardiac Surgery, Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland; †Department of Anesthesia and Intensive Care, Helsinki University Hospital, Helsinki, Finland; ‡Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden; §Division of Pediatric Cardiac Surgery, The Queen Silvia Children's Hospital, Gothenburg, Sweden; ¶Carmeda AB, Upplands Väsby, Sweden; and ‖Berlin Heart GmbH, Berlin, Germany.
Insights
The study shows that the CBAS Heparin Surface on EXCOR pumps remains durable and bioactive for at least one year of clinical use. This demonstrates excellent coating longevity for critical cardiac support devices.
Area of Science:
- Biomaterials Science
- Cardiovascular Engineering
- Surface Chemistry
Background:
- The EXCOR pump is a vital device for mechanical circulatory support.
- Ensuring the long-term functionality and biocompatibility of device surfaces is crucial for patient outcomes.
- The CBAS Heparin Surface is designed to improve biocompatibility by reducing thrombogenicity.
Purpose of the Study:
- To evaluate the durability and bioactivity of the CBAS Heparin Surface on EXCOR pumps after clinical use.
- To determine if heparin density and bioactivity degrade over time.
- To assess the suitability of the coating for mid-term and long-term clinical applications.
Main Methods:
- Analysis of 14 retrieved EXCOR pumps used clinically for 15 to 461 days.
- Measurement of surface heparin density (μg/cm²) and bioactivity (ρmol/cm²).
- Comparison of coating properties between housing and membrane components.
Main Results:
- Mean clinical use duration was 178 days.
- Mean heparin density was 3.1 ± 0.6 μg/cm²; mean bioactivity was 14 ± 5 ρmol/cm².
- No detectable degradation or loss of heparin function was observed, even up to 1 year of use.
Conclusions:
- The CBAS Heparin Surface exhibits excellent durability and maintains bioactivity on EXCOR pumps during clinical use.
- The coating remains effective for at least one year, supporting its use in bridge-to-transplantation or myocardial recovery scenarios.
- Findings support the long-term clinical viability of heparin-coated devices for advanced cardiac support.
Abstract:
The durability of CBAS Heparin Surface on EXCOR pumps retrieved after clinical use for varying periods of time was studied by analyzing samples for surface heparin density and bioactivity. The mean time of clinical use of the investigated 14 EXCOR pumps was 178 days (range, 15-461 days). Mean heparin density was 3.1 ± 0.6 μg/cm² (range, 2.2-4.8 μg/cm²), and the measured mean heparin bioactivity was 14 ± 5 ρmol/cm² (range: 7-27 ρmol/cm²). There was no detectable degradation or loss of function of CBAS Heparin Surface over time. Samples from the housing and the membrane of the EXCOR pump showed no significant difference in heparin bioactivity or density. The CBAS Heparin Surface stays on the surface and remains bioactive on the EXCOR pump at least up until 1 year. This is an important demonstration of coating durability and supports the mid-term and long-term clinical use as bridge-to-heart transplantation or to myocardial recovery.
