Background/Aim. Intramyocardial bone marrow mononuclear cells (BMMNC)
implantation concomitant to coronary artery bypass grafting (CABG) surgery
as an option for regenerative therapy in chronic ischemic heart failure was
tested in a very few number of studies, with not consistent conclusions
regarding improvement in left ventricular function, and with a follow-up
period between 6 months and 1 year. This study was focused on testing of the
hypothesis that intramyocardial BMMNC implantation, concomitant to CABG
surgery in ischemic cardiomyopathy patients, leads to better postoperative
long-term results regarding the primary endpoint of conditional
status-functional capacity and the secondary endpoint of mortality than CABG
surgery alone in a median follow-up period of 5 years. Methods. A total of
30 patients with ischemic cardiomyopathy and the median left ventricular
ejection fraction (LVEF) of 35.9 ? 4.7% were prospectively and randomly
enrolled in a single center interventional, open labeled clinical trial as
two groups: group I of 15 patients designated as the study group to receive
CABG surgery and intramyocardial implantation of BMMNC and group II of 15
patients as the control group to receive only the CABG procedure. All the
patients in both groups received the average of 3.4 ? 0.7 implanted coronary
grafts, and all of them received the left internal mammary artery (LIMA) to
the left anterior descending (LAD) and autovenous to other coronaries.
Results. The group with BMMNC and CABG had the average of 17.5 ? 3.8
injections of BMMNC suspension with the average number of injected bone
marrow mononuclear cells of 70.7 ? 32.4 ? 106 in the total average volume of
5.7 ? 1.5 mL. In this volume the average count of CD34+ and CD133+ cells was
3.96 ? 2.77 ? 106 and 2.65 ? 1.71 ? 106, respectively. All the patients were
followed up in 2.5 to 7.5 years (median, 5 years). At the end of the
follow-up period, significantly more patients from the group that received
BMMNC were in the functional class I compared to the CABG only group (14/15
vs 5/15; p = 0.002). After 6 months the results on 6-minute walk test
(6-MWT) were significantly different between the groups (435 m in the BMMNC
and CABG group and 315 m in the CABG only group; p = 0.001), and continued
to be preserved and improved on the final follow-up (520 m in the BMMNC and
CABG group vs 343 m in the CABG only group; p < 0.001). Cardiovascular
mortality was also significantly reduced in the BMMNC and CABG group (p =
0.049). Conclusion. Implanatation of BMMNC concomitant to CABG is a safe and
feasible procedure that demonstates not only the improved functional
capacity but also a reduced cardiac mortality in a 5-year follow-up in
patients with ischemic cardiomyopathy scheduled for CABG surgery.
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT
