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https://hdl.handle.net/11499/9642
Title: | Is high pressure postdilation safe in bioresorbable vascular scaffolds? Optical coherence tomography observations after noncompliant balloons inflated at more than 24 atmospheres | Authors: | Fabris, E. Caiazzo, G. Kılıç, İsmail Doğu Serdoz, R. Secco, G.G. Sinagra, G. Lee, R. |
Keywords: | bioresorbable vascular scaffolds coronary angioplasty noncompliant balloon optical coherence tomography struts apposition adult Article balloon bioresorbable scaffold clinical article cohort analysis controlled study drug eluting stent eccentricity index edge dissection female high pressure postdilation human in vivo study incomplete strut apposition male medical device complication optical coherence tomography device physical parameters pressure and tension residual area stenosis stent fracture stent malapposition symmetry index tissue prolapse adverse effects aged biodegradable implant coronary artery disease coronary blood vessel diagnostic imaging heart catheter mechanical stress middle aged predictive value pressure procedures prosthesis complication prosthesis design risk factor time factor transluminal coronary angioplasty treatment outcome biocompatible coated material cardiovascular agent Absorbable Implants Aged Angioplasty, Balloon, Coronary Cardiac Catheters Cardiovascular Agents Coated Materials, Biocompatible Coronary Artery Disease Coronary Vessels Female Humans Male Middle Aged Predictive Value of Tests Pressure Prosthesis Design Prosthesis Failure Risk Factors Stress, Mechanical Time Factors Tomography, Optical Coherence Treatment Outcome |
Publisher: | John Wiley and Sons Inc. | Abstract: | Objectives Optical coherence tomography (OCT) was used to investigate integrity and expansion of bioresorbable drug-eluting scaffolds (BVS) after high-pressure postdilation (HPPD). Background Because of concerns about the risk of BVS damage, postdilation was not recommended and applied in the existing randomized studies and most registries. Recent real world data suggest incomplete BVS expansion cause higher rates of thrombosis. In vivo confirmation of the safety of high pressure postdilation is of paramount importance. Methods Data from final OCT examination of consecutive implanted BVS, postdilated with noncompliant (NC) balloons at pressure ?24 atm were analyzed. The following stent performance indices were assessed with OCT: mean and minimal lumen and scaffold area, residual area stenosis (RAS), incomplete strut apposition (ISA), tissue prolapse, eccentricity index (EI), symmetry index (SI), strut fractures, and edge dissections. Result Twenty-two BVS postdilated at high pressure were analyzed. The average maximal postdilation balloon inflation (maxPD) was 28 ± 3 atm. High pressure OPN NC Balloon (SIS Medical AG, Winterthur Switzerland) was used in 41% of postdilations with a maximal PD of 30 ± 4.7 atm. Final mean and minimal lumen area were 6.8 ± 1.4 and 5.5 ± 1.4 mm2, respectively. OCT showed low percentage of RAS (16 ± 9.6%), and low percentage of ISA (1.8 ± 2.4%). Mean EI was 0.86 ± 0.02 and SI 0.35 ± 0.14. OCT analysis showed one edge dissection and no scaffold fractures. Conclusions BVS deployment optimization using HPPD does not cause BVS disruption and is associated with a good BVS expansion, low rate of strut malapposition and edge dissections. © 2015 Wiley Periodicals, Inc. | URI: | https://hdl.handle.net/11499/9642 https://doi.org/10.1002/ccd.26222 |
ISSN: | 1522-1946 |
Appears in Collections: | PubMed İndeksli Yayınlar Koleksiyonu / PubMed Indexed Publications Collection Scopus İndeksli Yayınlar Koleksiyonu / Scopus Indexed Publications Collection Tıp Fakültesi Koleksiyonu WoS İndeksli Yayınlar Koleksiyonu / WoS Indexed Publications Collection |
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