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Author Notes:

alfredo.rego2018@gmail.com

AR assisted with study design, collected, analyzed and interpreted study data and drafted and revised manuscript sections. PC analyzed and interpreted study data and drafted and revised manuscript sections. WH, KB, JN and RS collected and interpreted study data and revised manuscript sections. All authors read and approved the final manuscript.

A. rego, W. Harris, J. Newman and P. Cheung served as consultants to Aziyo Biologics, Inc. The authors have no other relevant affiliations or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Subject:

Research Funding:

The clinical trial was sponsored by Aziyo Biologics, Inc.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Surgery
  • Cardiovascular System & Cardiology
  • Pericardial closure
  • Coronary artery bypass grafting
  • Valve repair
  • Extracellular matrix
  • Pericardial effusion
  • Pleural effusion
  • Post-op atrial fibrillation
  • BYPASS GRAFT-SURGERY
  • OPEN-HEART-SURGERY
  • CORONARY-ARTERY
  • ATRIAL-FIBRILLATION
  • POSTERIOR PERICARDIOTOMY
  • CATASTROPHIC HEMORRHAGE
  • PLEURAL EFFUSIONS
  • RISK
  • TAMPONADE
  • PREVALENCE

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

Tools:

Journal Title:

JOURNAL OF CARDIOTHORACIC SURGERY

Volume:

Volume 14, Number 1

Publisher:

, Pages 61-61

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© The Author(s). 2019

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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