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

Abstract

BackgroundA 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.MethodsPatients 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.ResultsA 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.ConclusionsPericardial 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 registrationNCT02073331, Registered on February 27, 2014.Electronic supplementary materialThe online version of this article (10.1186/s13019-019-0871-5) contains supplementary material, which is available to authorized users.

Bearing My Heart: The Role of Extracellular Matrix on Cardiac Development, Homeostasis, and Injury Response

“…Cardiac-derived ECM, obtained by decellularization, has the benefit of conserving the organ-specific ECM architecture and composition and ensuing retention of biochemical cues that favor recellularization ( Kc et al, 2019 ) and has shown promising results in animal models ( Wainwright et al, 2012 ; Sarig et al, 2016 ; Wang et al, 2016 ) and for human applications ( Rego et al, 2019 ). However, decellularized matrices still pose many technical challenges that need to be addressed to meet clinical standards ( Kc et al, 2019 ).…”

Expert Opinions on the Debate of Pericardial Reconstruction in Cardiovascular Surgery: To Close or Not to Close?

“…In comparison to the NRD, the RECON outcomes favored PCR and showed statistically significant and clinically significant reductions in hospital readmissions, pleural effusion, pericardial effusion, and bleeding complications. Furthermore, POAF was far less common with PCR than in previously reported studies [Rego 2019].…”

“…The majority of studies published since 1995 have utilized a synthetic or biosynthetic pericardial substitute to reconstruct the pericardium. Among studies published since 1995, most reported no increase in complications or a beneficial clinical outcome, such as fewer adhesions by CT scan [Duvernoy 1995], lower rates of postoperative atrial fibrillation (POAF) [Boyd 2010;Kaya 2015;Rego 2019] increased epicardial surface to posterior sternal table distance [Rao 1999], reduced infection [ Kaya 2015], and fewer pericardial effusions [Kaya 2015;Rego 2019]. [Rego 2019].…”

“…Among studies published since 1995, most reported no increase in complications or a beneficial clinical outcome, such as fewer adhesions by CT scan [Duvernoy 1995], lower rates of postoperative atrial fibrillation (POAF) [Boyd 2010;Kaya 2015;Rego 2019] increased epicardial surface to posterior sternal table distance [Rao 1999], reduced infection [ Kaya 2015], and fewer pericardial effusions [Kaya 2015;Rego 2019]. [Rego 2019]. Most surgeries were CABG, valve replacement, or a combination of the two.…”

Extracorporeal life support to ventricular assist device: potential benefits of sternal-sparing approach

“…Minimizing the incidence When using the CSS approach, the pericardium is opened only over the apex and ascending aorta, preserving the pericardium's physiologic constraint over the entirety of the RV. A recent prospective, multicenter study demonstrated improved outcomes for coronary artery bypass graft (CABG) patients that underwent pericardial closure using a decellularized extracellular matrix graft, including fewer pericardial effusions, fewer postoperative arrhythmias, and fewer 30-day readmissions compared to patients with an unrepaired pericardiotomy (24). More research is needed into the role of the pericardium in LVAD recipients.…”