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Assessment of safety, accuracy and human CD34+ cell retention after intramyocardial injections With a helical needle catheter in a porcine model.
MedLine Citation:
PMID:  22581763     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVES: Assess accuracy of Helix injections via fluoroscopic-mapping and evaluate delivery safety. BACKGROUND: Percutaneous intramyocardial-delivery of agents must be safe and accurate; retention is also important. A delivery system (Helical Infusion/Morph Guide-Catheter, Biocardia Inc) has been developed to improve maneuverability and stability of catheter-needle-myocardium intersection. METHODS: Accuracy and safety: 12 swine underwent LV and coronary angiography via 8F sheath. Targeted delivery was assigned into LAD, LCX, or RCA. System was advanced into LV and 6 targeted intramyocardial dye injections (5mm apart) delivered using fluoroscopy. After euthanization, hearts underwent gross and histologic evaluation. Retention was assessed by iron-oxide and fluorochrome labeled CD34+ cells. Cells were injected into 6 swine using same techniques. Delivery system was advanced into LV, and injections delivered using fluoroscopy. Euthanization was performed at 2 hours and hearts formalin fixed. MRI was performed on 6 treated hearts and 4 untreated controls. Blinded analysis performed by 2 radiologists. Two treated hearts underwent immunohistologic analysis. RESULTS: Accuracy and safety evaluation: 71/72 injections (98.6%) were within pre-specified zone; 7/72 (9.7%) less than 5mm apart. No adverse events occurred. MRI-presence of iron-oxide labeled CD34+ cells were correctly identified in 95% (19/20) of imaged injections. Anti-CD34+ antibody staining and fluorescence microscopy confirmed CD34+ cells in myocardium. Histology confirmed cell viability at fixation. CONCLUSIONS: Helix system was accurate and safe. Retention of CD34+ cells was confirmed by MRI and immunohistology. Further preclinical studies are needed to characterize retention over time and quantify efficiency. Studies are needed to confirm accuracy, safety, and retention in humans. © 2012 Wiley Periodicals, Inc.
Authors:
Arun Kumar; Chris A Haralampus; Micah Hughes; Didier Rouy; Nate Cresswell; Ryan Braun; David Turner; David Amrani; Delara Motlagh; Gary L Schaer
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-5-14
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  -     ISSN:  1522-726X     ISO Abbreviation:  -     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-5-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
Affiliation:
Rush University Medical Center, Chicago, IL. kumararun@health.missouri.edu.
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