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

Alfredo Rego, Patricia C Cheung, William J Harris, Kevin M Brady, Jeffrey Newman, Robert Still, Alfredo Rego, Patricia C Cheung, William J Harris, Kevin M Brady, Jeffrey Newman, Robert Still

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.

Keywords: Coronary artery bypass grafting; Extracellular matrix; Pericardial closure; Pericardial effusion; Pleural effusion; Post-op atrial fibrillation; Valve repair.

Conflict of interest statement

Ethics approval and consent to participate

Ethics/Institutional review board approval was obtained through Western Institutional Review Board (WIRB Protocol # 20140138) and also with those local institutional review boards at participating centers as required. Participating patients provided informed consent per national and institutional requirements.

Consent for publication

Not applicable.

Competing interests

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.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Readmission rates of RECON and NRD cohorts after valve repair/readmission surgery. Stratified Cox model comparing readmission rates after valve repair/readmission surgery among patients in the RECON (n = 392) and NRD cohorts (n = 42, 269) after applying inverse probability of treatment weights
Fig. 2
Fig. 2
Readmission rates of RECON and NRD cohorts after coronary artery bypass graft surgery. Stratified Cox model comparing readmission rates after coronary artery bypass graft surgery among patients in the RECON (n = 866) and NRD (n = 57,364) cohorts after applying inverse probability of treatment weights

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