Assessment of safety, accuracy, and human CD34+ cell retention after intramyocardial injections with a helical needle catheter in a porcine model. Issue 6 (9th November 2012)

• Record Type: Journal Article
• Authors: Kumar, Arun; Haralampus, Chris A.; Hughes, Micah; Rouy, Didier; Cresswell, Nate; Braun, Ryan; Turner, David; Amrani, David; Motlagh, Delara; Schaer, Gary L.
• Is Part Of: Catheterization and cardiovascular interventions. Volume 81:Issue 6(2013:May 01)
• Page Start: 970
• Page End: 977
• Publication Date: 2012-11-09
• Subjects: Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.24476
• Languages: English
• ISSNs: 1522-1946

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="ccd24476-sec-0001" sec-type="section"> <title>Objectives</title> <p>Assess accuracy of Helix injections via fluoroscopic‐mapping and evaluate delivery safety.</p> </sec> <sec id="ccd24476-sec-0002" sec-type="section"> <title>Background</title> <p>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.</p> </sec> <sec id="ccd24476-sec-0003" sec-type="section"> <title>Methods</title> <p>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 (5 mm 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 hr 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 immunohistological analysis.</p> </sec> <sec id="ccd24476-sec-0004" sec-type="section"> <title>Results</title> <p>Accuracy and safety evaluation: 71/72 injections (98.6%) were within prespecified zone; 7/72 (9.7%) less than 5 mm 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.</p> </sec> <sec id="ccd24476-sec-0005" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> </abstract>