5. Periprocedural adverse events.
| Study ID | Periprocedural adverse events |
| Angeli 2012 | Not reported |
| Cao 2009 | 1 x transient acute heart failure 7 days after cell transplantation |
| Chen 2004 | Not reported |
| Colombo 2011 | No adverse events were reported until the end of hospitalisation |
| Gao 2013 | 1 x death 3 days after cell transplantation due to suspected acute in‐stent thrombosis; 1 x serious complication of acute coronary occlusion during cell injection with subsequent recurrent MI |
| Ge 2006 | No bleeding complications at BM puncture site and no angina aggravation, malignant diseases or substantial arrhythmias after PCI and BM transfer during hospitalisation in either treatment group |
| Grajek 2010 | Not reported |
| Hirsch 2011 | No complications of cell harvesting. A CK or CK‐MB elevation between 1 and 2 times the ULN was detected in 4 patients and between 2 and 3 times the ULN in one patient. 1 x occluded infarct‐related artery (patient did not receive cell therapy as randomised). During cell catheterisation: 1 x coronary spasm, 1 x transient brachycardia and 1 x thrombus in the infarct related artery |
| Huang 2006 | Not reported |
| Huang 2007 | Not reported |
| Huikuri 2008 | 3 x mild self terminating vasovagal reactions during BM aspiration; no other procedural complications relating to aspiration. Subacute stent thrombosis occurred in 4 patients (1 x cell therapy and 3 x placebo); 1 x cell therapy patient had 'no reflow' phenomenon after stenting of the infarcted artery |
| Janssens 2006 | 11 x treatment‐related tachycardia (supraventricular arrhythmia: 5 in the cell therapy group and 6 in the control group); 3 patients in the control group experienced non‐sustained ventricular tachycardia |
| Jazi 2012 | Not reported |
| Jin 2008 | Not reported |
| Karpov 2005 | No complications of BM aspiration or cell infusion |
| Lee 2014 | No serious inflammatory reactions or bleeding complications from BM aspiration. No (or mild) angina during balloon inflation. No serious procedural complications related to intracoronary administration of MSCs including ventricular arrhythmia, thrombus formation or dissection. Periprocedural MI occurred in 2 patients |
| Lunde 2006 | 2 x stent thrombosis in the acute phase in the cell therapy group (no cells administered as randomised); 1 x sustained ventricular tachycardia before cell administration; 1 x ventricular fibrillation at day 6, 24 hours after injection.1 x pulseless ventricular tachycardia in control patient ‐ converted to sinus rhythm by means of a precordial thump on day 2 |
| Meluzin 2008 | 2 patients had fever and 1 patient had brachycardia, all within 20 hours prior to cells (these patients did not receive cell therapy as randomised). 3 x cell therapy‐related complications: 1 x intimal dissection during repeat balloon inflations at time of cell implantation, 1 x short‐lasting fever on day of scheduled transplantation, 1 x small thrombus in infarct‐related artery diagnosed immediately after cell transplantation. 2 x control patients had repeat MI 2 days after the hospital discharge due to in‐stent thrombosis |
| Nogueira 2009 | Ck‐MB elevation (3 x normal value) in 3 patients in the arterial group and 1 patient in venous group. 1 x tortuous anterior interventricular vein (patient did not receive cell therapy as randomised). No new pericardial effusions |
| Penicka 2007 | 2 x serious complications (1 x stent thrombosis with reinfarction immediately after BM harvest, patient died 2 weeks later due to sepsis and acute respiratory distress syndrome; 1 x ventricular septal rupture before cell injection, patient died 3 months later from severe heart failure). |
| Piepoli 2010 | All procedures well tolerated. No inflammatory reaction or abscess detected at the site of puncture after BM harvest. The invasive coronary catheterisation was associated with some mild angina during balloon inflations for cell infusions. No procedural complications during cardiac catheterisation related to cell injections (no ventricular arrhythmia, new thrombus formation or embolism after cell infusion or dissections due to balloon inflations) |
| Plewka 2009 | Not reported |
| Quyyumi 2011 | 1 high‐dose treatment group patient died soon after cell infusion from ventricular fibrillation attributed to recurrent MI from stent thrombosis preceding cell infusion. 1 x high‐dose treatment group patient with acute stent thrombosis before cell infusion (patient withdrawn from study). Cell therapy group: 1 x arrhythmia, 1 x chest pain, 3 x musculoskeletal pain, 2 x upper respiratory tract infection, 2 x rash, 3 x dyspnoea, 1 x fever. Control group: 1 x arrhythmia, 3 x musculoskeletal pain, 1 x upper respiratory tract infection, 1 x dyspnoea |
| Roncalli 2010 | Cell therapy group: 1 x transient ischaemic attack and 1 x thrombopenia induced by GP2b3a inhibitor (both excluded before BM aspiration). Control group: 1 x steroids given for angioneurotic oedema; 1 x post‐MI ventricular septal defect (both withdrawn before day 7) |
| Ruan 2005 | Not reported |
| Schachinger 2006 | No bleeding complications or haematoma formation at puncture site of BM aspiration. 1 x patient was excluded owing to fever and an increase in the level of C‐reactive protein. 1 x patient in placebo group had angiographic evidence of a thrombus in a non‐infarct‐related artery (placebo medium not infused). 2 x deaths, cause not reported (1 x cell therapy group and 1 x placebo) and 2 x reinfarction (cell therapy group) prior to discharge |
| Suarez de Lezo 2007 | Not reported |
| Sürder 2013 | 1 death in cell therapy group prior to transplantation, cause of death not reported |
| Tendera 2009 | 1 patient developed arteriovenous fistula of the femoral artery after the procedure and required surgical treatment. No complications arising from BM cell transfer |
| Traverse 2010 | BM aspiration carried out without complications. No patient experienced a rise in troponin or procedure‐related complication following infusion |
| Traverse 2011 | No complications associated with BM aspiration. 2 x patients underwent additional stenting at time of cell infusion (1 x distal stent edge dissection related to primary PCI procedure; 1 x possible dissection related to stop‐flow procedure). 1 x postpartum spontaneous coronary dissection with diffuse thrombus throughout stented region of left anterior descending artery; 1 x presence of severe left main coronary stenosis identified before transfusion (this patient did not receive cell therapy as randomised). No patients experienced postprocedural increase in cardiac enzymes |
| Traverse 2012 | No complications associated with BM harvesting or intracoronary infusion. 1 x death in the BM cell therapy group due to subarachnoid haemorrhage prior to cell delivery |
| Turan 2012 | No procedural or cell‐induced complications and no side effects in any patient |
| Wang 2014 | Not reported |
| Wohrle 2010 | Not reported |
| Wollert 2004 | No bleeding complications at BM harvest site. No increases in troponin T serum levels in any patients 24 hours after BM transfer |
| Xiao 2012 | Not reported |
| Yao 2006 | 1 x temporary hypotension, 2 x brachycardia, 7 x new hyperuricaemia |
| Yao 2009 | 1 x brachycardia with subsequent pacemaker implantation, 1 x fever (these patients did not receive cells as randomised) |
| You 2008 | Not reported |
| Zhukova 2009 | Not reported |
MI, acute myocardial infarction; PCI, percutaneous coronary intervention; BM, bone marrow; MSC, mesenchymal stem cells; ULN, upper limit of normal