Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Frey, Norbert UNSPECIFIED orcid.org/0000-0001-7611-378X UNSPECIFIED Linke, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Sueselbeck, Tim UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller-Ehmsen, Jochen UNSPECIFIED UNSPECIFIED UNSPECIFIED Vermeersch, Paul UNSPECIFIED UNSPECIFIED UNSPECIFIED Schoors, Danny UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosenberg, Mark UNSPECIFIED UNSPECIFIED UNSPECIFIED Bea, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Tuvia, Shmuel UNSPECIFIED UNSPECIFIED UNSPECIFIED Leor, Jonathan UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language ALGINATE; HEART; ISCHEMIA; RAT Multiple languages Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42239