Frey, Norbert ORCID: 0000-0001-7611-378X, Linke, Axel, Sueselbeck, Tim, Mueller-Ehmsen, Jochen, Vermeersch, Paul, Schoors, Danny, Rosenberg, Mark, Bea, Florian, Tuvia, Shmuel and Leor, Jonathan (2014). Intracoronary Delivery of Injectable Bioabsorbable Scaffold (IK-5001) to Treat Left Ventricular Remodeling After ST-Elevation Myocardial Infarction A First-in-Man Study. Circ.-Cardiovasc. Interv., 7 (6). S. 806 - 813. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1941-7632

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Abstract

Background-We aimed to test, for the first time, the feasibility of intracoronary delivery of an innovative, injectable bioabsorbable scaffold (IK-5001), to prevent or reverse adverse left ventricular remodeling and dysfunction in patients after ST-segment-elevation myocardial infarction. Methods and Results-Patients (n=27) with moderate-to-large ST-segment-elevation myocardial infarctions, after successful revascularization, were enrolled. Two milliliters of IK-5001, a solution of 1% sodium alginate plus 0.3% calcium gluconate, was administered by selective injection through the infarct-related coronary artery within 7 days after myocardial infarction. IK-5001 is assumed to permeate the infarcted tissue, cross-linking into a hydrogel and forming a bioabsorbable cardiac scaffold. Coronary angiography, 3 minutes after injection, confirmed that the injection did not impair coronary flow and myocardial perfusion. Furthermore, IK-5001 deployment was not associated with additional myocardial injury or re-elevation of cardiac biomarkers. Clinical assessments, echocardiographic studies, 12-lead electrocardiograms, 24-hour Holter monitoring, blood tests, and completion of Minnesota Living with Heart Failure Questionnaires were repeated during follow-up visits at 30, 90, and 180 days after treatment. During a 6-month follow-up, these tests confirmed favorable tolerability of the procedure, without device-related adverse events, serious arrhythmias, blood test abnormalities, or death. Serial echocardiographic studies showed preservation of left ventricular indices and left ventricular ejection fraction. Conclusions-This first-in-man pilot study shows that intracoronary deployment of an IK-5001 scaffold is feasible and well tolerated. Our results have promoted the initiation of a multicenter, randomized controlled trial to confirm the safety and efficacy of this new approach in high-risk patients after ST-segment-elevation myocardial infarction.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Frey, NorbertUNSPECIFIEDorcid.org/0000-0001-7611-378XUNSPECIFIED
Linke, AxelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sueselbeck, TimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller-Ehmsen, JochenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vermeersch, PaulUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schoors, DannyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rosenberg, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bea, FlorianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tuvia, ShmuelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Leor, JonathanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-422391
DOI: 10.1161/CIRCINTERVENTIONS.114.001478
Journal or Publication Title: Circ.-Cardiovasc. Interv.
Volume: 7
Number: 6
Page Range: S. 806 - 813
Date: 2014
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 1941-7632
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ALGINATE; HEART; ISCHEMIA; RATMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/42239

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