Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions

• Type of Material: Article
• Authors: Alfredo Rego, South Florida Heart & Lung Institute; Patricia Cheung, Emory University; William J. Harris, Baptist Health System; Kevin M. Brady, Southwest Heart & Lung; Jeffrey Newman, Tenet Health Care; Robert Still, Baptist Health
• Language: English
• Date: 2019-03-15
• Publisher: BMC
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s). 2019
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s13019-019-0871-5
• Title of Journal or Parent Work: JOURNAL OF CARDIOTHORACIC SURGERY
• Volume: 14
• Issue: 1
• Start Page: 61
• End Page: 61
• Grant/Funding Information: The clinical trial was sponsored by Aziyo Biologics, Inc.
• Keywords: Coronary artery bypass grafting; Cardiac & Cardiovascular Systems; Life Sciences & Biomedicine; Post-op atrial fibrillation; PREVALENCE; BYPASS GRAFT-SURGERY; ATRIAL-FIBRILLATION; Extracellular matrix; Pericardial effusion; Pericardial closure; Pleural effusion; TAMPONADE; Valve repair; POSTERIOR PERICARDIOTOMY; Science & Technology; Cardiovascular System & Cardiology; CORONARY-ARTERY; CATASTROPHIC HEMORRHAGE; PLEURAL EFFUSIONS; Surgery; OPEN-HEART-SURGERY; RISK
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Background: A prospective, multi-center study (RECON) was conducted to evaluate the clinical outcomes of pericardial closure using a decellularized extracellular matrix (ECM) graft derived from porcine small intestinal submucosa. Methods: Patients indicated for open cardiac surgery with pericardial closure using ECM were eligible for the RECON study cohort. Postoperative complications and readmission of the RECON patients were compared to the patient cohort in the Nationwide Readmissions Database (NRD). Inverse probability of treatment weighting was used to control the differences in patient demographics, comorbidities, and risk factors. Results: A total of 1420 patients at 42 centers were enrolled, including 923 coronary artery bypass grafting (CABG) surgeries and 436 valve surgeries. Significantly fewer valve surgery patients in the RECON cohort experienced pleural effusion (3.1% vs. 13.0%; p < 0.05) and pericardial effusion (1.5% vs. 2.6%; p < 0.05) than in the NRD cohort. CABG patients in the RECON cohort were less likely to suffer bleeding (1.2% vs. 2.9%; p < 0.05) and pericardial effusion (0.2% vs. 2.2%, p < 0.05) than those in the NRD cohort. The 30-day all-cause hospital readmission rate was significantly lower among RECON patients than NRD patients following both valve surgery (HR: 0.34; p < 0.05) and CABG surgery (HR: 0.42; p < 0.05). In the RECON study, 14.4% of CABG patients and 27.0% of valve patients had postoperative atrial fibrillation as compared to previously reported risks, which generally ranges from 20 to 30% after CABG and from 35 to 50% after valve surgery. Conclusions: Pericardial closure with ECM following cardiac surgery is associated with a reduction in the proportion of patients with pleural effusion, pericardial effusion, and 30-day readmission compared to a nationwide database. Trial registration: NCT02073331, Registered on February 27, 2014.