Prophylactic Fibrinogen Decreases Postoperative Bleeding but Not Acute Kidney Injury in Patients Undergoing Heart Transplantation

The present study is the premier clinical attempt to scrutinize the practicability of prophylactic fibrinogen infusion in patients undergoing heart transplantation (HT). A total of 67 consecutive patients who had undergone HT between January 2012 and December 2014 were assessed. After exclusion of some patients, 23 patients were given preoperative 2 g fibrinogen concentrate over a period of 15 minutes after the termination of cardiopulmonary bypass pump and complete reversal of heparin, and 30 patients were not given. Some laboratories were measured before general anesthesia and at 6 and 24 hours after surgery. In addition, major adverse events were also evaluated during hospitalization. The mean age of the patients was 39.5 ± 11.4 years, with a predominance of male sex (77.4). All laboratories at baseline were comparable between groups. The length of hospital stay was longer in the control group compared to the fibrinogen group (20 16-22 vs 16 12-19 days; P =.005). There was a trend for patients in the fibrinogen group to have more acute kidney injury (AKI) after surgery (10% vs 30.4%) and less reoperation for bleeding (20% vs 8.7%). The amount of postoperative bleeding was significantly higher in the control group compared to the fibrinogen group (P <.001). The number of packed red blood cell transfused during 24 hours after surgery was significantly lower in the fibrinogen group (P <.001). The transfusion of fibrinogen in patients undergoing HT may be associated with reductions in postoperative bleeding, the number of packed red blood cells, and hospital length of stay; however, it may enhance postoperative AKI. © The Author(s) 2017

Erratum: COMPARE CPM-RMI trial: Intramyocardial transplantation of autologous bone marrow-derived CD133+ cells and MNCs during CABG in patients with recent MI: A phase II/III, multicenter, placebo-controlled, randomized, double-blind clinical trial. (Cell Journal (2018) 20:3 (449) DOI: 10.22074/cellj.2018.5197)

This article published in Cell J (Yakhteh), Vol 20, No 2, Jul-Sep 2018, on pages 267-277, four affiliations (1, 4, 5, and 10) were changed based on authors request. © 2018 Royan Institute (ACECR). All rights reserved

COMPARE CPM-RMI Trial: Intramyocardial transplantation of autologous bone marrow-derived CD133+ Cells and MNCs during CABG in patients with recent MI: A Phase II/III, multicenter, placebo-controlled, randomized, double-blind clinical trial

Objective: The regenerative potential of bone marrow-derived mononuclear cells (MNCs) and CD133+ stem cells in the heart varies in terms of their pro-angiogenic effects. This phase II/III, multicenter and double-blind trial is designed to compare the functional effects of intramyocardial autologous transplantation of both cell types and placebo in patients with recent myocardial infarction (RMI) post-coronary artery bypass graft. Materials and Methods: This was a phase II/III, randomized, double-blind, placebo-controlled trial COMPARE CPM-RMI (CD133, Placebo, MNCs - recent myocardial infarction) conducted in accordance with the Declaration of Helsinki that assessed the safety and efficacy of CD133 and MNCs compared to placebo in patients with RMI. We randomly assigned 77 eligible RMI patients selected from 5 hospitals to receive CD133+ cells, MNC, or a placebo. Patients underwent gated single photon emission computed tomography assessments at 6 and 18 months post-intramyocardial transplantation. We tested the normally distributed efficacy outcomes with a mixed analysis of variance model that used the entire data set of baseline and between-group comparisons as well as within subject (time) and group�time interaction terms. Results: There were no related serious adverse events reported. The intramyocardial transplantation of both cell types increased left ventricular ejection fraction by 9 95% confidence intervals (CI): 2.14% to 15.78%, P=0.01 and improved decreased systolic wall thickening by -3.7 (95% CI: -7.07 to -0.42, P=0.03). The CD133 group showed significantly decreased non-viable segments by 75% (P=0.001) compared to the placebo and 60% (P=0.01) compared to the MNC group. We observed this improvement at both the 6- and 18-month time points. Conclusion: Intramyocardial injections of CD133+ cells or MNCs appeared to be safe and efficient with superiority of CD133+ cells for patients with RMI. Although the sample size precluded a definitive statement about clinical outcomes, these results have provided the basis for larger studies to confirm definitive evidence about the efficacy of these cell types (Registration Number: NCT01167751). © 2018 Royan Institute (ACECR). All Rights Reserved

COVID-19: A perspective from Iran

The coronavirus disease 2019 (COVID-19) pandemic has presented unique challenges to healthcare systems the world over. The management of the current pandemic places a huge strain on healthcare sectors and demands new strategies on a global level. We herein review the latest epidemiologic data on the COVID-19 pandemic, the Iranian healthcare system's response, and the impact on cardiac surgery practice in Iran. © 2020 Wiley Periodicals LL

Superior vena cava obstruction after heart transplantation

Superior vena cava obstruction can be a serious complication after heart transplantation. A 58-year-old man with ischemic cardiomyopathy underwent orthotopic bicaval heart transplantation. On the 12th postoperative day, one hour after removing the central venous line, he developed sudden onset of facial edema, cyanosis, and tachycardia. Emergency transesophageal echocardiography revealed superior vena caval thrombosis at the site of anastomosis. Considering the risks of surgical reexploration, the superior vena cava was recanalized by stent deployment. All of the patient's symptoms were relieved a few hours after stent placement. © 2014 SAGE Publications

Superior vena cava obstruction after heart transplantation

Superior vena cava obstruction can be a serious complication after heart transplantation. A 58-year-old man with ischemic cardiomyopathy underwent orthotopic bicaval heart transplantation. On the 12th postoperative day, one hour after removing the central venous line, he developed sudden onset of facial edema, cyanosis, and tachycardia. Emergency transesophageal echocardiography revealed superior vena caval thrombosis at the site of anastomosis. Considering the risks of surgical reexploration, the superior vena cava was recanalized by stent deployment. All of the patient's symptoms were relieved a few hours after stent placement. © 2014 SAGE Publications

Development of a Translational Model to Assess the Impact of Opioid Overdose and Naloxone Dosing on Respiratory Depression and Cardiac Arrest

In response to a surge of deaths from synthetic opioid overdoses, there have been increased efforts to distribute naloxone products in community settings. Prior research has assessed the effectiveness of naloxone in the hospital setting; however, it is challenging to assess naloxone dosing regimens in the community/first-responder setting, including reversal of respiratory depression effects of fentanyl and its derivatives (fentanyls). Here, we describe the development and validation of a mechanistic model that combines opioid mu receptor binding kinetics, opioid agonist and antagonist pharmacokinetics, and human respiratory and circulatory physiology, to evaluate naloxone dosing to reverse respiratory depression. Validation supports our model, which can quantitatively predict displacement of opioids by naloxone from opioid mu receptors in vitro, hypoxia-induced cardiac arrest in vivo, and opioid-induced respiratory depression in humans from different fentanyls. After validation, overdose simulations were performed with fentanyl and carfentanil followed by administration of different intramuscular naloxone products. Carfentanil induced more cardiac arrest events and was more difficult to reverse than fentanyl. Opioid receptor binding data indicated that carfentanil has substantially slower dissociation kinetics from the opioid receptor compared with nine other fentanyls tested, which likely contributes to the difficulty in reversing carfentanil. Administration of the same dose of naloxone intramuscularly from two different naloxone products with different formulations resulted in differences in the number of virtual patients experiencing cardiac arrest. This work provides a robust framework to evaluate dosing regimens of opioid receptor antagonists to reverse opioid-induced respiratory depression, including those caused by newly emerging synthetic opioids