A clinical comparison of glycol and water-based heater-cooler systems for cardiopulmonary bypass

Abstract

Introduction

While newer heater-cooler technologies using ethylene glycol-based (GB) solutions during cardiothoracic surgery have become commercially available, there is a paucity of clinical data describing their effectiveness during cardiopulmonary bypass (CPB) support. This analysis aimed to compare clinical characteristics and procedural outcomes using water-based (WB) and GB heater-cooler systems.

Methods

A retrospective analysis was performed on consecutive adult patients undergoing CPB from June to October 2022 comparing WB or GB groups. The primary outcome was a composite of operative death or major morbidity. Secondary endpoints included transfusion requirements on CPB, patient cooling and warming rates, and vasoactive-inotropic scores (VIS) at case completion. P-control charts were used to monitor the weekly incidence of the composite outcome. A sub-analysis was performed to evaluate the primary outcome for cardiac surgery cases indexed by the Society of Thoracic Surgeons (STS).

Results

There were 167 patients included for analysis; 87 (52.1%) underwent CPB with a WB system and 80 (47.9%) with a GB system. GB procedure subjects were younger (p = .01), experienced longer CPB times (p = .034), and were more likely to receive thoracic transplant or aortic surgery (p = 0.015). The composite outcome of operative mortality or major morbidity occurred in 29.9% and 24% of the WB and GB groups, respectively (p = .372). P-control charts indicated a weekly mean incidence of 30% during WB practice, which decreased to 24% with GB practice. Among 106 STS-indexed cardiac surgery cases, mean composite outcome incidence decreased from 19% to 6% following our GB transition. Additionally, cooling, and warming rates indexed to patient BSA and VIS at case completion were not significantly different.

Conclusion

Our analysis demonstrated a safe transition from WB to GB heater-cooler technologies in our practice. This early analysis suggests that GB heater coolers may be safely adopted to mitigate the risks of nontuberculous mycobacterium infections for cardiac surgical patients.

Keywords

cardiopulmonary bypass heater-cooler temperature hypothermia glycol

Get full access to this article

View all access options for this article.

References

Sealy

Brown

Young

. A report on the use of both extracorporeal circulation and hypothermia for open heart surgery. Ann Surg 1958; 147(5): 603–613.

Miller

. Chapter 14 - biomedical transport processes. In Enderle

John D

Bronzino

Joseph D

(eds) Biomedical engineering, introduction to biomedical engineering. 3rd ed.. Academic Press, 2012, pp. 937–993.

Sax

Bloemberg

Hasse

, et al. Prolonged outbreak of Mycobacterium chimaera infection after open-chest heart surgery. Clin Infect Dis 2015; 61(1): 67–75.

Lyman

Grigg

Kinsey

, et al. Invasive nontuberculous mycobacterial infections among cardiothoracic surgical patients exposed to heater-cooler Devices1. Emerg Infect Dis 2017; 23(5): 796–805.

Chand

Lamagni

Kranzer

, et al. Insidious risk of severe mycobacterium chimaera infection in cardiac surgery patients. Clin Infect Dis 2016; 64(3): 335–342.

U.S. Food and Drug Administration . FDA's ongoing evaluation and continued monitoring of reports of nontuberculous mycobacteria infections associated with water-based heater-cooler devices. https://www.fda.gov/medical-devices/what-heater-cooler-device/fdas-ongoing-evaluation-and-continued-monitoring-reports-nontuberculous-mycobacteria-infections, (accessed 25 Jan 2024).

Condello

Nasso

Serraino

, et al. The evolution of temperature management for cardiac surgery: a historical perspective. J Cardiothorac Vasc Anesth 2022; 36(8 Pt B): 3237–3243.

Spectrum Medical . CE approval for the Quantum heater-cooler. Retrieved Jan. 25, 2024, at: https://www.spectrummedical.com/news/ce-approval-for-the-quantum-heater-cooler.

Spectrum Medical . FDA recognizes the Quantum heater-cooler. Retrieved Jan. 24, 2024, at: https://www.spectrummedical.com/news/fda-recognizes-the-quantum-heater-cooler.

10.

Engelman

Baker

Likosky

, et al. The society of thoracic Surgeons, the society of cardiovascular anesthesiologists, and the American society of ExtraCorporeal technology: clinical practice guidelines for cardiopulmonary bypass--temperature management during cardiopulmonary bypass. Ann Thorac Surg 2015; 100(2): 748–757.

11.

Madhavan

Chan

Tan

, et al. Cardiopulmonary bypass time: every minute counts. J Cardiovasc Surg 2018; 59(2): 274–281.

12.

Liu

, et al. Cardiopulmonary bypass time is an independent risk factor for acute kidney injury in emergent thoracic aortic surgery: a retrospective cohort study. J Cardiothorac Surg 2019; 14: 90.

13.

Pupovac

Hemli

Giammarino

, et al. Deep versus moderate hypothermia in acute type A aortic dissection: a propensity-matched analysis. Heart Lung Circ 2022; 31(12): 1699–1705.

14.

Ghia

Savadjian

Shin

, et al. Hypothermic circulatory arrest in adult aortic arch surgery: a review of hypothermic circulatory arrest and its anesthetic implications. J Cardiothorac Vasc Anesth 2023; 37(12): 2634–2645.

15.

Salsano

Giacobbe

Sportelli

, et al. Aortic cross-clamp time and cardiopulmonary bypass time: prognostic implications in patients operated on for infective endocarditis. Interact Cardiovasc Thorac Surg 2018; 27(3): 328–335.

16.

Al-Sarraf

Thalib

Hughes

, et al. Cross-clamp time is an independent predictor of mortality and morbidity in low- and high-risk cardiac patients. Int J Surg 2011; 9(1): 104–109.

17.

Tibi

McClure

Huang

, et al. STS/SCA/AmSECT/SABM update to the clinical practice guidelines on patient blood management. Ann Thorac Surg 2021; 112(3): 981–1004.

18.

Dickinson

Sturmer

, et al. Net prime volume is associated with increased odds of blood transfusion. J Extra Corpor Technol 2019;51(4):195-200.

19.

Gaies

Jeffries

Niebler

, et al. Vasoactive-inotropic score is associated with outcome after infant cardiac surgery: an analysis from the pediatric cardiac critical care consortium and virtual PICU system registries. Pediatr Crit Care Med 2014; 15(6): 529–537.

20.

Health C for D and R . Cardiopulmonary bypass oxygenators 510(k) submissions - final guidance for industry and FDA staff. FDA [Internet], 2021. Available from: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cardiopulmonary-bypass-oxygenators-510k-submissions-final-guidance-industry-and-fda-staff.