Assessment of safety, accuracy, and human CD34+ cell retention after intramyocardial injections with a helical needle catheter in a porcine model

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
Arun KumarGary L Schaer

Abstract

Assess accuracy of Helix injections via fluoroscopic-mapping and evaluate delivery safety. 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. 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. Accuracy and safety evaluation: 71/72 injections (98.6%) were within prespecified zone; 7/72 (9.7%) less th...Continue Reading

References

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Citations

Oct 22, 2014·Netherlands Heart Journal : Monthly Journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation·F J van SlochterenS A J Chamuleau
Feb 4, 2014·Mayo Clinic Proceedings·Eoin D O'CearbhaillJeffrey M Karp
Apr 4, 2015·Heart Failure Clinics·Amit N PatelAmalia A Winters
May 26, 2017·International Heart Journal·Yoshiaki MitsutakeFumiaki Ikeno
Oct 13, 2016·Circulation. Cardiovascular Interventions·Francis G Spinale
Dec 12, 2013·Circulation. Cardiovascular Interventions·Atta BehfarAndre Terzic
May 4, 2021·Journal of Ultrasound in Medicine : Official Journal of the American Institute of Ultrasound in Medicine·Minako KatayamaMarek Belohlavek

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