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Assessment of explanted PTCA balloons
D Behrend1, G Zinner, K Sternberg
1University of Rostock, Institute of Biomedical Engineering, Germany.
Insights
This study investigated explanted percutaneous transluminal coronary angioplasty (PTCA) catheters, revealing adherent protein layers and embedded plaque particles on all deployed devices. Water-insoluble proteins were detected, highlighting potential risks associated with catheter re-use.
Area of Science:
- Biomaterials Science
- Medical Device Analysis
- Cardiovascular Technology
Background:
- Percutaneous transluminal coronary angioplasty (PTCA) involves using balloon catheters.
- Catheter re-use is a concern due to potential surface contamination.
- Understanding the surface properties of explanted catheters is crucial.
Purpose of the Study:
- To characterize the surface of explanted PTCA balloon catheters.
- To identify adhered substances, including proteins and plaque particles.
- To evaluate the impact of angioplasty on catheter surface integrity.
Main Methods:
- Examination of 168 explanted PTCA balloon catheters from six types and three manufacturers.
- Utilized light microscopy, scanning electron microscopy (SEM), X-ray microanalysis, and FT-IR-ATR spectroscopy.
- Employed silver staining and Lowry analysis for protein detection.
Main Results:
- All deployed PTCA catheters showed adherent protein layers and embedded plaque particles.
- SEM revealed fissuring and micro-tearing on balloon surfaces.
- Lowry analysis confirmed the presence of water-insoluble proteins (average 17 microg/ml), while silver staining and FT-IR-ATR did not detect proteins.
Conclusions:
- Explanted PTCA catheters are consistently coated with adherent, water-insoluble proteins and debris.
- Surface damage, including micro-tearing, is evident after deployment.
- These findings underscore the risks associated with PTCA catheter re-use.
Abstract:
The data presented here are part of a on-going study to define the surface characteristics and properties of explanted PTCA catheters in a further effort to address some of the ramifications of the re-use issue. PTCA balloon catheter were examined after angioplasty in one hundred and sixty-eight patients (n = 168). This series included six balloon types from three manufacturers. The fresh fixed and dehydrated balloons were examined at first with light microscopy and then in a scanning electron microscope. X-ray semiquantitative microanalysis and FT-IR-ATR analysis were also performed on the balloons. Because most blood proteins are water soluble, we examined unfixed balloons with a protein silver staining kit for detection of adhered proteins described by Heukeshoven. A further method for protein detection is the Lowry-analysis. With this method water insoluble proteins can be observed. Our study has shown convincingly that all deployed angioplasty catheters were coated with adherent protein layers. Plaque particles were found embedded in the surfaces of most of the balloons examined. Fissuring and micro tearing of balloon surfaces was noted. FT-IR-ATR analyses of the blood contacted balloon surfaces did not show any peaks indicative of proteins on the balloon surface. The silver staining method also did not show any evidence of protein adsorption on the balloons. On the other hand, the Lowry-analysis yielded clear evidence that water insoluble proteins were adherent to the balloon surfaces. The average measured protein concentration was 17 microg/ml.