NEPHROCHECK Biomarkers TIMP-2 and IGFBP7 Included in Groundbreaking Consensus Statement of Best Practices to Enhance Recovery after Heart Surgery

Marcy l’Étoile (France) and San Diego (California) - May 2nd, 2018 – The biomarkers in the NEPHROCHECK test, an FDA-cleared and CE-marked urine test that indicates kidney stress in advance of acute kidney injury (AKI), have been included in consensus guidelines from ERAS^® Cardiac Surgery, a non-profit, multi-professional and multi-disciplinary medical society whose mission is to optimize perioperative care of cardiac surgical patients through collaborative discovery, analysis, expert consensus, and dissemination of best practices that will improve both short- and long-term outcomes and decrease complications and readmissions.

This follows the recent publication of two randomized controlled trials^1,2 that demonstrated significant improvement in patient outcomes, length of stay, and decreased costs due to AKI following cardiac and non-cardiac surgery by using NEPHROCHECK to initiate kidney-protecting interventions.

The new guidelines were presented as part of evidenced-based expert consensus statements at the American Association for Thoracic Surgery (AATS) meeting on April 28th, 2018. These were developed in a formal process over 15 months to provide cardiac surgery programs best practices to enhance recovery after surgery. It is anticipated that the final work product will be submitted for peer review publication, facilitating its dissemination to surgeons and heart programs around the world.

“We hope that these recommendations will encourage cardiac surgical programs around the world to join us to standardize best practice,” said ERAS^® Cardiac Surgery President Daniel T. Engelman, M.D.. “Since our inaugural meeting a year ago, we’ve solicited input, considered protocols, and assessed the class and strength of evidence for each that may help enhance recovery after heart surgery. This is the first time such a comprehensive evidence-based approach has been presented at a major cardiovascular surgery meeting.”

“Evidence-based patient care guidelines are crucial for standardizing medical care and enhancing patient outcomes,” said Mark Miller, Executive Vice President and Chief Medical Officer for bioMérieux. “NEPHROCHECK is a simple, urine-based test that provides vital information to healthcare providers so that they can act promptly to prevent harmful consequences for the patient’s kidneys. The evidence continues to grow that routine use of NEPHROCHECK will be an important tool for improving the management of adult cardiac surgery patients in order to protect their kidneys from both acute and long-term damage. Additional studies of NEPHROCHECK in other patient populations are also underway.”

AKI is a frequent complication in patients undergoing major surgery, and is known to increase morbidity, mortality and costs³. Additional AKI-associated expenses during U.S. hospitalizations have been reported at $38,000 per patient⁴, resulting in U.S. healthcare expenditures between $5.4 to $24 billion annually⁵. Currently available indicators of AKI, such as elevated blood levels of creatinine, may not be present until kidney damage has already occurred⁶. Recent studies have called for the pursuit of innovative strategies to combat this major public health concern^7,8.

1 Göcze I, Jauch D, Götz M, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BigpAK Study. Ann Surg. Published online August 2017.

2 Meersch M, Schmidt C, Hoffmeier A, et al. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Jan 21.

3 Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

4 Alshaikh H, Katz N, Gani F, et al. Financial Impact of Acute Kidney Injury After Cardiac Operations in the United States. Ann Thorac Surg. 2018 Feb;105(2):469-475.

5 Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. 2017;137:297-301.

6 McCullough PA, Shaw AD, Haase M, et al. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth Acute Dialysis Quality Initiative Consensus Conference. Contrib Nephrol. 2013;182:13-29.

7 Thakar CV. Acute Kidney Injury: A Paradigm In Quality and Patient Safety. Adv Chronic Kid Dis. 2017;24(4):192-193.

8 Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. https://doi.org/10.1159/000475607. Published online June 9, 2017.