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Postoperative Pericardial Adhesion Prevention Using Collagen Membrane in Pigs: A Pilot Study.

ABSTRACT: The operating procedure of a resternotomy in open-heart surgery is a complicated procedure with potentially problematic outcomes partly due to potential adhesions in the pericardial cavity and retrosternal space. Use of a collagen membrane has shown encouraging results in adhesion prevention in several regions of the body. This study was designed to evaluate the effectiveness of the use of this collagen membrane in the prevention of pericardial adhesions.A total of 12 pigs were divided randomly into 2 groups: an experimental group in which collagen membranes were used and a control group. After sternotomy and an anterior pericardiectomy, the epicardial surface was exposed to room air and irrigated with saline, and an epicardial abrasion was performed using a sponge. The pericardial defect was repaired using a collagen membrane in the experimental group or left uncovered in the control group. After 8 to 12 weeks, the pigs were killed, and a resternotomy was performed by a single-blinded surgeon enabling the evaluation of adhesions. The heart was then removed and sent for microscopic assessment conducted by a single-blinded pathologist.The resternotomy operations performed using a collagen membrane demonstrated a nonstatistically significant trend of fewer macroscopic and microscopic adhesions in all regions (P > .05), particularly in the retrosternal and defect regions.This study showed nonstatistically significant differences between the outcomes in the collagen membrane group and the control group in both macroscopic and microscopic adhesion prevention. Due to the many limitations in animal study design, further studies in human models will be needed before the true value of this procedure can be evaluated.

SUBMITTER: Taksaudom N

PROVIDER: S-EPMC5518959 | biostudies-other | 2017

REPOSITORIES: biostudies-other

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Project description:BackgroundProlonged or excessive bleeding after cardiac surgery can lead to a broad spectrum of secondary complications. One of the underlying causes is incomplete wound drainage, with subsequent accumulation of blood and clots in the pericardium. We developed the continuous postoperative pericardial flushing (CPPF) therapy to improve wound drainage and reduce postoperative blood loss and bleeding-related complications after cardiac surgery. This study compared CPPF to standard care in patients after coronary artery bypass grafting (CABG).MethodsThis is a single center, open label, randomized trial that enrolled patients at the Amsterdam UMC, location AMC, Amsterdam, the Netherlands. The study was registered at the 'Netherlands Trial Register', study identifier NTR5200 [1]. Adults undergoing CABG were randomly assigned to receive CPPF therapy or standard care, participants and investigators were not masked to group assignment. The primary end point was postoperative blood loss in the first 12-hours after surgery.FindingsBetween the January 15, 2014 and the March 13, 2017, 169 patients were enrolled and assigned to CPPF therapy (study group; n = 83) or standard care (control group; n = 86). CPPF reduced postoperative blood loss when compared to standard care (median differences -385 ml, reduction 76% p=≤0.001), with the remark that these results are overestimated due to a measurement error in part of the study group. None of patients in the study group required reoperation for non-surgical bleeding versus 3 (4%, 95% CI -0.4% to 7.0%) in the control group. None of the patients in the study group suffered from cardiac tamponade, versus 3 (4%, 95% CI -0,4% to 7.0%) in the control group. The incremental cost-effectiveness ratio was €116.513 (95% bootstrap CI €-882.068 to €+897.278).InterpretationThe use of CPPF therapy after CABG seems to reduce bleeding and bleeding related complications. With comparable costs and no improvement in Qualty of Life (QoL), cost consideration for the implementation of CPPF is not relevant. None of the patients in the study group required re-interventions for non-surgical bleeding or acute cardiac tamponade, which underlines the proof of concept of this novel therapy.FundingThis study was funded by ZonMw, the Netherlands organization for health research and development (project 837001405).

Project description:BackgroundThe Oxalert Enhanced Pulse Oximeter (EPO) is a wearable device that detects and alerts patients to hypoxemia. In a preplanned pilot trial, we estimated the effect of continuous saturation monitoring with patient alerts on in-hospital and post-discharge saturation; we further assessed the feasibility of the intervention.MethodsNoncardiac surgical patients were randomized to either the Oxalert with patient alerts (Monitor + Alert, N = 25) or the Oxalert without patient alerts (Monitor Only, N = 24). Monitoring continued during hospitalization for up to 6 days and for 24 h after hospital discharge. Patients in each group were compared on time-weighted average (TWA) SpO2 <90% (%) and area under SpO2 <90% (% * min) in-hospital and after discharge using the Wilcoxon rank sum test, with the treatment effect median difference and 95% confidence interval (CI) estimated using the Hodges-Lehmann estimator of location shift.ResultsWe enrolled ≥2 patients per week, for a total of 49 patients in whom recording were obtained for a median [quartiles] of 91 [85, 95]% of the time in hospital. In-hospital, TWA SpO2 <90% was a median [quartiles] of 0.11 [0.03, 0.25]% for Monitor + Alert and 0.29 [0.04, 0.71]% for Monitor-Only patients, with estimated median difference (95% CI) of -0.1 (-0.4, 0)%, p = .120. In hospital, the area under the curve (AUC) SpO2 <90% was a median [quartiles] of 635 [204, 1513] % * min for Monitor + Alert and 1260 [117, 5278] % * min for Monitor-Only patients, with estimated median difference (95% CI) of -407 (-1816, 208) % * min, p = .349. Post-discharge, the estimated median difference (95% CI) was only -0.1 (-0.2, 0) %, p = .307.ConclusionsThe Oxalert system was well tolerated in both groups and enrollment was strong. Patients randomized to active Oxalert systems experienced half as many postoperative desaturation events while hospitalized, although the difference was not statistically significant in this small pilot trial. In contrast, the Oxalert system did not reduce post-discharge desaturation. Detecting postoperative deterioation in surgical patients after they arrive on regular hospital wards, and even after they have been discharged home, can potentially facilitate necessary "rescue" interventions. Wearable devices assessing vital signs, including oxygenation, are a practical requirement. In this pilot study, a wearable pulse oximeter, with and without hypoxemia alarms, was tested for feasibility and acceptability for signal collection in postoperative cases, including at home. Results indicate that a full-scale trial is warranted to test for possible clinical benefit with this type of "wearable" where late postoperative hypoxia could be a concern. The trial was registered at ClincialTrial.gov (NCT04453722).

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Postoperative Pericardial Adhesion Prevention Using Collagen Membrane in Pigs: A Pilot Study.

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