Revealing Mechanisms and Investigating Efficacy of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis - REMOVE

Mar 05, 2024
Font Size
A
A
A
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
The Federal Ministry of Education and Research (BMBF), Germany
Date Published:
02/28/2024
Date Updated:
03/05/2024
Original Posted Date:
03/30/2022
References

Contribution To Literature:

Highlighted text has been updated as of March 5, 2024.

Among patients with infective endocarditis undergoing cardiac surgery in the REMOVE trial, intraoperative hemoadsorption using CytoSorb reduced some inflammatory cytokines postoperatively compared with control, but there was no change in clinical outcomes/organ dysfunction.

Description:

The goal of the trial was to compare the safety and efficacy of an intraoperative hemoadsorption device for patients undergoing cardiac surgery for infective endocarditis (IE).

Study Design

Eligible patients were randomized in a 1:1 open-label fashion to either intraoperative hemoadsorption during cardiopulmonary bypass (CPB) using CytoSorb (n = 138) or control (n = 144). The hemoadsorption device was integrated into the CPB.

  • Total screened: 740
  • Total number of enrollees: 282
  • Duration of follow-up: 30 days
  • Mean patient age: 69 years
  • Percentage female: 25%

Inclusion criteria:

  • Age ≥18 years
  • IE based on modified Duke criteria

Exclusion criteria:

  • European System for Cardiac Operative Risk Evaluation Score (EuroSCORE) II <3 (low mortality risk)
  • Pregnancy
  • Immunosuppressive or immunomodulatory therapy

Other salient features/characteristics:

  • EuroSCORE II at baseline: 20%
  • SOFA (sequential organ failure assessment) score: 5.6
  • Previous cardiac surgery: 48%
  • Abscess: 27%
  • Urgent/emergent surgery: 71%
  • Microbiology: Streptococcus: 27%, Staphylococcus aureus: 26%, Enterococcus faecalis: 19%

Principal Findings:

The primary outcome, change in SOFA between hemoadsorption vs. control compared with baseline, was 1.79 vs. 1.93 (p = 0.67).

Secondary outcomes for hemoadsorption vs. control:

  • 30-day mortality: 21% vs. 22.4% (p = 0.78)
  • Postoperative stroke: 3.6% vs. 2.1% (p = 0.44)
  • Hospital length of stay: 20 vs. 19 days (p = 0.39)
  • Distributive shock: 68.1% vs. 70.8% (p = 0.70)

At the end of CPB, median changes to baseline levels were greater in the hemoadsorption group than in the control group for the following inflammatory mediators: C-terminal proendothelin-1 (CT-proET-1; -95.5 vs. -26.8, p = 0.01), midregional pro-adrenomedullin (MR-proADM; -0.5 vs. 0.1, p < 0.01).

Role of transesophageal echocardiography (TEE) and cardiac troponin (cTn): Sensitivity and specificity of TEE to identify abscess correctly were 58% and 86%, respectively. The area under the curve (AUC) of high-sensitivity (hs)-cTnI for predicting abscess was 0.689 (95% confidence interval [CI], 0.58-0.80; p = 0.001) with an optimal cut-off according to the Youden index of 1.12-fold upper reference limit (URL), resulting in a sensitivity of 88.6% and a specificity of 44.9%. The AUC of hs-cTnT for predicting abscess was 0.56 (95% CI, 0.43-50.69; p = 0.353) with an optimal cut-off according to the Youden index of 116.57-fold URL, resulting in a sensitivity of 34.5% and a specificity of 82%. The combination of TEE and hs-cTnI findings performed well in predicting abscess with an AUC of 0.835 (95% CI, 0.75-0.91; p < 0.001), while the combination of TEE and hs-cTnT performed poorly in predicting abscess with an AUC of 0.634 (95% CI, 0.50-0.77; p = 0.068).

Interpretation:

The results of this trial indicate that, among patients with IE undergoing cardiac surgery, intraoperative hemoadsorption using CytoSorb reduced some inflammatory cytokines postoperatively compared with control, but there was no change in clinical outcomes/organ dysfunction. This was a sick cohort; 30-day mortality was >20%.

Among patients with confirmed root abscess intraoperatively, adding preoperative hs-cTnI but not hs-cTnT values to TEE findings might improve cardiac abscess detection in patients with IE.

References:

Diab M, Moschovas A, Franz M, et al., on behalf of the REMOVE Trial Investigators. Research Letter: Improving Preoperative Abscess Detection in Infective Endocarditis by Adding Troponin I: A REMOVE Trial Analysis. JACC Cardiovasc Imaging 2024;Feb 28:[Epublished].

Diab M, Lehmann T, Bothe W, et al., on behalf of the REMOVE Trial Investigators. Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial. Circulation 2022;145:959-68.

Clinical Topics: Cardiac Surgery and VHD

Keywords: Cardiopulmonary Bypass, Endocarditis


< Back to Listings