A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trial†.

AIMS: Clinical trials suggest that intracoronary delivery of autologous bone marrow-derived cells (BMCs) 1-7 days post-acute myocardial infarction (AMI) may improve left ventricular (LV) function. Earlier time points have not been evaluated. We sought to determine the effect of intracoronary autologous BMC on LV function when delivered within 24 h of successful reperfusion therapy. METHODS AND RESULTS: A multi-centre phase II randomized, double-blind, and placebo-controlled trial. One hundred patients with anterior AMI and significant regional wall motion abnormality were randomized to receive either intracoronary infusion of BMC or placebo (1:1) within 24 h of successful primary percutaneous intervention (PPCI). The primary endpoint was the change in left ventricular ejection fraction (LVEF) between baseline and 1 year as determined by advanced cardiac imaging. At 1 year, although LVEF increased compared with baseline in both groups, the between-group difference favouring BMC was small (2.2%; 95% confidence interval, CI: -0.5 to 5.0; P = 0.10). However, there was a significantly greater myocardial salvage index in the BMC-treated group compared with placebo (0.1%; 95% CI: 0.0-0.20; P = 0.048). Major adverse events were rare in both treatment groups. CONCLUSION: The early infusion of intracoronary BMC following PPCI for patients with AMI and regional wall motion abnormality leads to a small non-significant improvement in LVEF when compared with placebo; however, it may play an important role in infarct remodelling and myocardial salvage.

Wound management and restrictive arm movement following cardiac device implantation - evidence for practice?

BACKGROUND: The rate of cardiac device implantation has risen significantly secondary to an increase in the number of indications. Wound infection and lead displacement are two common and potentially life-threatening complications. No national/international guidelines address postoperative care and controversy exists regarding wound management and arm movement following cardiac device implantation. AIMS: We aimed to explore and review the evidence behind current practice but found that certain aspects of established practice. METHODS: An electronic search of the databases EMBASE, British Nursing Index, CINAHL, Cochrane and PubMed to identify evidence regarding wound management and lead displacement. FINDINGS: We found that certain aspects of established practice are based on tradition rather than evidence. Recent guidelines on wound management published by The National Institute for Health and Clinical Excellence in the UK recommend covering the wound postoperatively for 48 h with a low-adherent transparent dressing and letting patients shower thereafter. Since specific guidelines for cardiac device patients are lacking, we suggest that further research address whether or not the NICE guidelines can be extrapolated to this area. Studies showed that early mobilisation and allowing a full range of arm movements following device implantation is safe. Further research must validate these findings. CONCLUSION: We discuss the reasons behind these gaps in the evidence base and support the idea that nursing education has not placed enough emphasis on how to critically appraise research. This accounts for the very small proportion of nurses that get involved in conducting research and generating guidelines. Additionally, we argue that nurses can play a key role in identifying and addressing research questions that lead to improved patient outcome. Thus, we support proposals to enhance nurses' opportunities to pursue academic careers to achieve adequate research skills.