First in human intramyocardial extracellular matrix implant in patients with low ejection fraction heart failure to restore ventricular viability and function -early and midterm results.
Piotr Suwalski, Radoslaw Smoczynski, Slawomir Sypula, Mariusz Furmanek, Wojciech Sarnowski, Anna Witkowska, Dominik Drobinski, Jakub Staromlynski, Zygmunt Kalicinski, Jaroslaw Swistowski, Kazimierz Suwalski.
Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland.
OBJECTIVE: Myocardial regeneration in heart failure still remains unachieved purpose in medical therapies. This first in human study was designed to evaluate the safety and feasibility of the CorMatrix P-ECM (Particulate-Extracellular Matrix) delivered trans-epicardially to subjects with low left ventricular ejection fraction (LVEF) during coronary artery bypass grafting (CABG).
METHODS: It is a single-arm, open-label, feasibility, safety study of the P-ECM device. The P-ECM is administered by implantation within the damaged ischemic and/or infarcted myocardium of subjects with LVEF 25 to 40% during CABG surgery. Additionally epicardial echo is performed using special design hardware and software to assess thickness of the myocardium in site of implantation. Subject-level incidence of serious adverse device effects (SADEs) or serious implantation procedure-related adverse events that occur within 6 months of implantation of the P-ECM. Global ventricular function and single wall motion are assessed by comparing paired resting cardiac echocardiographic measures and stress magnetic resonance at baseline and 6, 12, 18 months postoperatively.
RESULTS: P-ECM was implanted in 9 human, with mean LVEF 35±4,8% and LV mass 217±94,9g into infarcted wall of myocardium during beating heart CABG (mean no. of grafts 2,7). Mean injected sites were 35,12±(6,45 to 51,61) cm2 and injection volume 4,0 +/- 0,7 ml. ECM implant time was 37,9+/-15,0min. 100% procedural and device success was achieved. 5mm needles obtain a more desirable injection depth in comparison to 3mm. No SADEs were observed through 90 Days. Constant increase in EF and LV mass were noticed in 1, 3 and 6 months postoperative follow-up. Adverse events occurred in two patients (sternal Infection, acute respiratory failure, death on 24 postoperative day from massive duodenal bleeding). Autopsy of the expired subject showed protrusion into the muscle and scar and neoangiogenesis in injected sites.
CONCLUSIONS: Delivery of p-ECM into the ventricle wall with the CorMatrix System is safe and feasible. 90 day results demonstrated safety of the procedure. P-ECM remained in the implantation regions (no wash-out). Histology from one patient showed promising results for angiogenesis and myocardial remodeling. Longer follow-up is however warranted to further assessment results of the treatment.
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