Abstract 12592: Sustained Clinical Benefit in Patients With Chronic Post-Infarction Heart Failure Treated With Shockwave-Facilitated Intracoronary Administration of Bone Marrow-Derived Cells: Long-Term Follow-Up of the Randomized, Placebo-Controlled Cellwave Trial
The modest effects of initial clinical studies using intracoronary (i.c.) administration of autologous bone marrow-derived mononuclear cells (BMC) in patients with chronic post-infarction heart failure (CHF) have been attributed to impaired homing of the applied BMC to the target area. In the double-blind CELLWAVE trial, preconditioning of the target area by extracorporeal shockwave (SW) application resulted in a significant improvement in LVEF 4 months after i.c. BMC administration in patients with CHF. The present analysis reports the long-term clinical outcome after shockwave-facilitated BMC administration.
Methods: 103 patients were randomized to either shockwave application targeted to the left ventricular anterior wall followed by followed by i.c. BMC application (n=43) or placebo (n=39) after 24 hours, or to placebo shockwave application followed by i.c. administration of BMC (n=21).
Results: Complete follow-up data were obtained in 101 (98%) patients, 2 patients were lost-to-follow-up. Mean follow-up time was 45.7±17 months. A total of 18 patients died, 8 of 39 (21%) in the shockwave + Placebo group, 4 of 21 (19%) in the Placebo shockwave + BMC group and 6 of 43 (14%) in the shockwave +BMC group (p=0.72). The table summarizes the occurrence of individual major cardiovascular events (MACE) as well as the number of affected patients. The cumulative cardiovascular event burden including death, repeat myocardial infarction, rehospitalization for worsening heart failure, stroke and ventricular tachycardia was significantly lower in patients receiving shockwave + BMC compared to the Placebo-shockwave + BMC and the shockwave + Placebo group (p<0.05).
Conclusion: In patients with chronic post-infarction heart failure, the significant improvement of LVEF at 4 months induced by the use of shockwave-facilitated i.c. BMC administration is associated with sustained reduction of cumulative major adverse clinical events during long-term follow-up.
Author Disclosures: J. Klotsche: None. D.H. Walter: None. F.H. Seeger: None. A. Lutz: Employment; Modest; Dornier Med. Tech. W. Khaled: Employment; Modest; Dornier Med. Tech. S. Dimmeler: Consultant/Advisory Board; Modest; t2cure. A.M. Zeiher: Consultant/Advisory Board; Modest; t2cure.
- © 2014 by American Heart Association, Inc.