Equivalence and endothelial safety of temporary intracoronary shunt device: Insights from preclinical porcine and rabbit models.
<h4>Background</h4>This preclinical investigation evaluated the operational equivalence of a temporary intracoronary shunt (TICS) device while documenting patterns of endothelial repair during the perioperative period.<h4>Methods</h4>Porcine coronary bypass models were establ...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2025-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0329864 |
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| Summary: | <h4>Background</h4>This preclinical investigation evaluated the operational equivalence of a temporary intracoronary shunt (TICS) device while documenting patterns of endothelial repair during the perioperative period.<h4>Methods</h4>Porcine coronary bypass models were established using off-pump (OPCAB) and on-pump beating-heart surgical approaches. Through a triple randomization design, test devices and predicate counterparts were deployed in left/right coronary arteries. Equivalence was determined at postoperative day 7 through tripartite analysis: 1) sequential laboratory measurements (preoperative to 7-day follow-up), 2) histopathological evaluation of vascular specimens, and 3) angiographic assessment. Extreme-sized device validation employed rabbit carotid arteries (small-caliber vascular bed) and abdominal aortae (large-caliber model), with equivalence criteria encompassing hemodynamic stability (flow velocity, trans-device pressure differentials) and microarchitectural preservation (endothelial integrity, internal elastic lamina continuity).<h4>Results</h4>In the conventional device cohort (12 target vessels), no perioperative type 5 myocardial infarction occurred. Postoperative CTA confirmed patent lumens and unobstructed distal flow in all vessels. Cardiac biomarkers (troponin, CK-MB, myoglobin) showed no significant differences at preoperative, 4h, 8h, 24h, 72h, or 7-day timepoints (P ≥ 0.05). For extreme-sized devices, hemodynamic parameters (mean proximal/distal pressure: test vs. predicate, P ≥ 0.05) and endothelial outcomes, including elastic lamina injury scores, demonstrated equivalence between test and predicate devices.<h4>Conclusion</h4>Functional parity between TICS and predicate devices was established in both porcine and lagomorph models, with observed endothelial alterations demonstrating transient characteristics limited to the acute perioperative window. |
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| ISSN: | 1932-6203 |