Novel Guidewire Design and Coating for Continuous Delivery of Adenosine During Interventional Procedures

Background The “no‐reflow phenomenon” compromises percutaneous coronary intervention outcomes. There is an unmet need for a device that prevents no‐reflow phenomenon. Our goal was to develop a guidewire platform comprising a nondisruptive hydrophilic coating that allows continuous delivery of adenos...

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Main Authors: Mervyn B. Forman, Erik C. Brewer, Zachary R. Brown, Elizabeth V. Menshikova, Anthony M. Lowman, Edwin K. Jackson
Format: Article
Language:English
Published: Wiley 2021-02-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
Subjects:
Online Access:https://www.ahajournals.org/doi/10.1161/JAHA.120.019275
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author Mervyn B. Forman
Erik C. Brewer
Zachary R. Brown
Elizabeth V. Menshikova
Anthony M. Lowman
Edwin K. Jackson
author_facet Mervyn B. Forman
Erik C. Brewer
Zachary R. Brown
Elizabeth V. Menshikova
Anthony M. Lowman
Edwin K. Jackson
author_sort Mervyn B. Forman
collection DOAJ
description Background The “no‐reflow phenomenon” compromises percutaneous coronary intervention outcomes. There is an unmet need for a device that prevents no‐reflow phenomenon. Our goal was to develop a guidewire platform comprising a nondisruptive hydrophilic coating that allows continuous delivery of adenosine throughout a percutaneous coronary intervention. Methods and Results We developed a guidewire with spaced coils to increase surface area for drug loading. Guidewires were plasma treated to attach hydroxyl groups to metal surfaces, and a methoxy–polyethylene glycol–silanol primer layer was covalently linked to hydroxyl groups. Using polyvinyl alcohol, polyvinyl pyrrolidone, and polyvinyl acetate, a drug layer containing jet‐milled adenosine was hydrogen‐bonded to the polyethylene glycol–silanol layer and coated with an outer diffusive barrier layer. Coatings were processed with a freeze/thaw curing method. In vitro release studies were conducted followed by in vivo evaluation in pigs. Coating quality, performance, and stability with sterilization were also evaluated. Antiplatelet properties of the guidewire were also determined. Elution studies with adenosine‐containing guidewires showed curvilinear and complete release of adenosine over 60 minutes. Porcine studies demonstrated that upon insertion into a coronary artery, adenosine‐releasing guidewires induced immediate and robust increases (2.6‐fold) in coronary blood flow velocity, which were sustained for ≈30 minutes without systemic hemodynamic effects or arrhythmias. Adenosine‐loaded wires prevented and reversed coronary vasoconstriction induced by acetylcholine. The wires significantly inhibited platelet aggregation by >80% in vitro. Guidewires passed bench testing for lubricity, adherence, integrity, and tracking. Conclusions Our novel drug‐releasing guidewire platform represents a unique approach to prevent/treat no‐reflow phenomenon during percutaneous coronary intervention.
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spelling doaj.art-e13847c8e4864544a6cbe055bd45c4fb2022-12-22T00:02:58ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802021-02-0110310.1161/JAHA.120.019275Novel Guidewire Design and Coating for Continuous Delivery of Adenosine During Interventional ProceduresMervyn B. Forman0Erik C. Brewer1Zachary R. Brown2Elizabeth V. Menshikova3Anthony M. Lowman4Edwin K. Jackson5Cardiovascular Associates of Sandy Springs Atlanta GADepartment of Biomedical Engineering Rowan University Glassboro NJDepartment of Biomedical Engineering Rowan University Glassboro NJDepartment of Pharmacology and Chemical Biology University of Pittsburgh Pittsburgh PADepartment of Biomedical Engineering Rowan University Glassboro NJDepartment of Pharmacology and Chemical Biology University of Pittsburgh Pittsburgh PABackground The “no‐reflow phenomenon” compromises percutaneous coronary intervention outcomes. There is an unmet need for a device that prevents no‐reflow phenomenon. Our goal was to develop a guidewire platform comprising a nondisruptive hydrophilic coating that allows continuous delivery of adenosine throughout a percutaneous coronary intervention. Methods and Results We developed a guidewire with spaced coils to increase surface area for drug loading. Guidewires were plasma treated to attach hydroxyl groups to metal surfaces, and a methoxy–polyethylene glycol–silanol primer layer was covalently linked to hydroxyl groups. Using polyvinyl alcohol, polyvinyl pyrrolidone, and polyvinyl acetate, a drug layer containing jet‐milled adenosine was hydrogen‐bonded to the polyethylene glycol–silanol layer and coated with an outer diffusive barrier layer. Coatings were processed with a freeze/thaw curing method. In vitro release studies were conducted followed by in vivo evaluation in pigs. Coating quality, performance, and stability with sterilization were also evaluated. Antiplatelet properties of the guidewire were also determined. Elution studies with adenosine‐containing guidewires showed curvilinear and complete release of adenosine over 60 minutes. Porcine studies demonstrated that upon insertion into a coronary artery, adenosine‐releasing guidewires induced immediate and robust increases (2.6‐fold) in coronary blood flow velocity, which were sustained for ≈30 minutes without systemic hemodynamic effects or arrhythmias. Adenosine‐loaded wires prevented and reversed coronary vasoconstriction induced by acetylcholine. The wires significantly inhibited platelet aggregation by >80% in vitro. Guidewires passed bench testing for lubricity, adherence, integrity, and tracking. Conclusions Our novel drug‐releasing guidewire platform represents a unique approach to prevent/treat no‐reflow phenomenon during percutaneous coronary intervention.https://www.ahajournals.org/doi/10.1161/JAHA.120.019275adenosinecardiac guidewireno‐reflow phenomenonpercutaneous coronary intervention
spellingShingle Mervyn B. Forman
Erik C. Brewer
Zachary R. Brown
Elizabeth V. Menshikova
Anthony M. Lowman
Edwin K. Jackson
Novel Guidewire Design and Coating for Continuous Delivery of Adenosine During Interventional Procedures
Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
adenosine
cardiac guidewire
no‐reflow phenomenon
percutaneous coronary intervention
title Novel Guidewire Design and Coating for Continuous Delivery of Adenosine During Interventional Procedures
title_full Novel Guidewire Design and Coating for Continuous Delivery of Adenosine During Interventional Procedures
title_fullStr Novel Guidewire Design and Coating for Continuous Delivery of Adenosine During Interventional Procedures
title_full_unstemmed Novel Guidewire Design and Coating for Continuous Delivery of Adenosine During Interventional Procedures
title_short Novel Guidewire Design and Coating for Continuous Delivery of Adenosine During Interventional Procedures
title_sort novel guidewire design and coating for continuous delivery of adenosine during interventional procedures
topic adenosine
cardiac guidewire
no‐reflow phenomenon
percutaneous coronary intervention
url https://www.ahajournals.org/doi/10.1161/JAHA.120.019275
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