SIR 2024
Venous Interventions
Marios Platon Dimopoulos, MD,MSc
Resident
University Hospital of Patras, Greece
Disclosure information not submitted.
Christos Papageorgiou, MD
Attending
General University Hospital of Patras, Greece
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Stavros Spiliopoulos, MD, PhD
ass Professor
Interventional Radiology Unit, 2nd Department of Radiology, School of Medicine, National and Kapodistrian University of Athens, Attikon University General Hospital, Athens, Greece., Greece
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Lazaros Reppas, MD, PhD
ATTENDing Radiologist
Interventional Radiology Unit, 2nd Department of Radiology, School of Medicine, National and Kapodistrian University of Athens, Attikon University General Hospital, Athens, Greece., Greece
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Michalis Theofanis, MD
Attending Radiologist
General University Hospital of Patras, Greece
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George Labropoulos, MD
ATTENDING VASCULAR SURGEON
Vascular Surgery Department, Nikaia Hospital, Athens, Greece., Greece
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Konstantinos Katsanos, MD, PhD, MS
Ass Professor
General University Hospital of Patras, Greece
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Dimitrios Karnabatidis, MD, PhD, EBIR, FCIRSE
Professor in Interventional Radiology
Interventional Radiology, Patras University Hospital, Greece
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Panagiotis Kitrou, MD, PhD
Asst. Prof. in Interventional Radiology
Patras University Hospital, Greece
Disclosure information not submitted.
To evaluate the feasibility, safety, and Everolimus (EVR) deliverability of a novel non-commercially available Everolimus-Coated Balloon (ECB) catheter in an in vivo swine healthy peripheral vein model.
Materials and Methods:
In total 12 ECBs were inflated in 12 venous segments. Primary feasibility endpoint was a successful inflation of the ECB to the target veins. Primary efficacy endpoint was to determine the drug concentration within target venous tissue at 24 hours and 7 days, using High Performance Liquid Chromatography and tandem mass spectrometry. The primary safety endpoint was freedom from major adverse events. Secondary endpoint was to identify factors affecting the primary endpoints.
Results:
Everolimus was detected in all six tissue samples at 24 hours post-intervention and in four out of six samples at 7 days (10/12; 83.33% of tissue samples). The mean weight of the examined tissue was 0.20604±0.29822g (range: 0,37475-0,02229g) and the mean PTX concentration detected was 8.4±13.1 μg/g (range: 0-36.1μg/g). The average EVR tissue content detected at 24 hours (135,67 ± 204,95 μg/g) was numerically superior, but non-statistically significant, compared to 7 days (96,85 ± 110,89 μg/g). The average quantity of EVR that remained on the balloon after retrieval was 33.9% . Multiple linear regression analysis, did not identify any significant correlation between transition time, immediate (24h) or short term (7 days) tissue analysis, EVR remaining on the balloon and EVR tissue concentration. No adverse events were recorded and no abnormalities were noted during autopsy.
Conclusion:
The feasibility and safety of the novel ECB was determined as the it successfully delivered a large dose of Everolimus within the healthy venous wall, without adverse events at short-term follow-up.