Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure.
BACKGROUND
Cell-based therapies are a promising option in patients with acute myocardial infarction or chronic heart failure (CHF). However, administration of cells requires intracoronary or intracardiac instrumentation, which is potentially associated with periprocedural risks. Therefore, we analyzed periprocedural complications and 30-day outcome in 775 consecutive procedures of intracoronary administration of progenitor cells using the stop-flow technique.


RESULTS
Indications for cell administration were acute myocardial infarction (n=126) and CHF of ischemic (n=562) or nonischemic (n=87) etiology. Vessel injury was observed in a total of 9 procedures (1.2%) and could be promptly managed by additional progenitor cell injection (PCI) in all but 1 case. No procedural deaths were observed. A periprocedural increase in troponin T was observed in 3.2% of the CHF procedures, in which no concomitant PCI was performed and troponin levels were not elevated before the procedure. Independent significant predictors of troponin T increase were higher New York Heart Association (NYHA) class (NYHA I versus NYHA IV; P=0.01; NYHA I versus III; P=0.19; NYHA I versus II; P=0.55), concomitant revascularization (P<0.01), presence of elevated troponin T before the procedure (P<0.01), and peripheral occlusive disease (P=0.04). At 30 days, there were 4 deaths (0.5%), 1 stroke (0.13%), 8 acute myocardial infarctions (1%), and 5 hospitalizations for exacerbation of heart failure (0.64%).


CONCLUSIONS
Intracoronary infusion of progenitor cells can be performed with adequate safety in patients with acute myocardial infarction or CHF, because the safety profile was similar to what is usually expected from a coronary angiogram in the present cohort.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00962364, NCT00284713, and NCT00289822.
Division of Cardiology, Department of Medicine III, Goethe University Frankfurt, Germany.
Salvatore
S
De Rosa
Florian H
FH
Seeger
Jörg
J
Honold
Ulrich
U
Fischer-Rasokat
Ralf
R
Lehmann
Stephan
S
Fichtlscherer
Volker
V
Schächinger
Stefanie
S
Dimmeler
Andreas M
AM
Zeiher
Birgit
B
Assmus
D000328:Adult; D000368:Aged; D000572:American Heart Association; D001854:Bone Marrow Cells / Q000166:cytology*; D002908:Chronic Disease; D017023:Coronary Angiography; D005260:Female; D006333:Heart Failure / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery*; D009518:New York; D011237:Predictive Value of Tests; D011379:Prognosis; D033581:Stem Cell Transplantation; D020107:Troponin T / Q000378:metabolism*; D014481:United States
D020107:Troponin T