PMID- 23362308 OWN - NLM STAT- MEDLINE DCOM- 20130812 LR - 20130220 IS - 1941-7632 (Electronic) IS - 1941-7640 (Linking) VI - 6 IP - 1 DP - 2013 Feb TI - 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. PG - 44-51 LID - 10.1161/CIRCINTERVENTIONS.112.971705 [doi] AB - 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. METHODS AND 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00962364, NCT00284713, and NCT00289822. FAU - De Rosa, Salvatore AU - De Rosa S AD - Division of Cardiology, Department of Medicine III, Goethe University Frankfurt, Germany. FAU - Seeger, Florian H AU - Seeger FH FAU - Honold, Jorg AU - Honold J FAU - Fischer-Rasokat, Ulrich AU - Fischer-Rasokat U FAU - Lehmann, Ralf AU - Lehmann R FAU - Fichtlscherer, Stephan AU - Fichtlscherer S FAU - Schachinger, Volker AU - Schachinger V FAU - Dimmeler, Stefanie AU - Dimmeler S FAU - Zeiher, Andreas M AU - Zeiher AM FAU - Assmus, Birgit AU - Assmus B LA - eng SI - ClinicalTrials.gov/NCT00284713 SI - ClinicalTrials.gov/NCT00289822 SI - ClinicalTrials.gov/NCT00962364 PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20130129 PL - United States TA - Circ Cardiovasc Interv JT - Circulation. Cardiovascular interventions JID - 101499602 RN - 0 (Troponin T) SB - IM MH - Adult MH - Aged MH - American Heart Association MH - Bone Marrow Cells/*cytology MH - Chronic Disease MH - Coronary Angiography MH - Female MH - Heart Failure/*surgery MH - Humans MH - Male MH - Middle Aged MH - Myocardial Infarction/*surgery MH - New York MH - Predictive Value of Tests MH - Prognosis MH - *Stem Cell Transplantation MH - Troponin T/*metabolism MH - United States EDAT- 2013/01/31 06:00 MHDA- 2013/08/13 06:00 CRDT- 2013/01/31 06:00 PHST- 2013/01/31 06:00 [entrez] PHST- 2013/01/31 06:00 [pubmed] PHST- 2013/08/13 06:00 [medline] AID - CIRCINTERVENTIONS.112.971705 [pii] AID - 10.1161/CIRCINTERVENTIONS.112.971705 [doi] PST - ppublish SO - Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29.