Authors' objectives: To identify evidence evaluating the efficacy, safety, and economic implication of Custodiol HTK solution as compared with those obtained using blood cardioplegia in patients undergoing various type of cardiac surgeries.

Authors' results and conclusions: There was substantial fair level of retrievable evidence to suggest that a single dose of Custodiol HTK is as effective as repetitive blood cardioplegia in protecting the myocardium in patients (adult and paediatric) undergoing various surgical status (elective, urgent or emergent) and type of cardiac surgeries including coronary artery bypass grafting (CABG), congenital heart, valve repair and/or replacement (aortic/ mitral), and aortic surgery. Both cardioplegia strategies had similar rate for myocardial infarction (MI), the release of cardiac enzyme (creatine kinase myocardial band [CK-MB) and troponin-I, electrocardiographic changes, low cardiac output syndrome (LCOS) or inotropes support, rhythm disturbances (atrial fibrillation [AF] and ventricular fibrillation [VF] RR, blood transfusion or blood product use, cardiopulmonary bypass (CPB) and aortic cross-clamp time. Findings also indicated that Custodial HTK compared favourably with blood cardioplegia with regard to less severe endothelial injury (postoperative endothelin-1 [ET-1] level and flow-mediated dilation [FMD] value, incidence of postoperative segmental wall motion abnormalities (SWMA) at postoperative echocardiography, and shorter mechanical ventilation time. Patients receiving Custodiol HTK had a similar risk of mortality as patients receiving blood cardioplegia for myocardial protection in adults and paediatrics. Postoperative complications such as pulmonary, gastrointestinal, reoperation for bleeding, and renal dysfunction or renal failure were also comparable between the two strategies. No significant differences were identified between patients receiving Custodiol HTK and blood cardioplegia during cardiovascular surgery in terms of length of intensive care unit (ICU) and hospital stay and readmission rate as well. The cost-effectiveness of Custodiol HTK for myocardial protection has not yet been formally evaluated. The first study to look closely at the financial analysis of the solution indicated that there was less hospital readmission within 30 days when using Custodiol HTK cardioplegia which contributed to a significant reduction in patient charge by an average USD3,103 per patient.

Authors' recommendations: Given the current available evidence with an acceptable safety profile and potential financial benefits, Custodiol HTK may be considered as feasible option for blood cardioplegia to enhance myocardial protection in cardiac surgery although protection of the myocardium, endothelial injury, postoperative mechanical ventilation and stays in ICU are very much depends on combination factors (severity of patients disease, comorbidities, type of patient and surgery, perioperative conditions of patients, duration of surgery/ CPB/ cross-clamp, and competency of the surgeons), not solely on the cardioplegia.

Authors' methods: A systematic review was conducted. Review protocol and search strategy was developed by the main author while literature search was conducted by an Information Specialist who searched for published articles related to myocardial protection that comparing Custodiol HTK with conventional cardioplegia (either blood or extracellular crystalloid) in patient undergoing cardiac surgery. The following electronic databases were searched through the Ovid interface: MEDLINE (R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions (R) 1946 to Mar 2021. Parallel searches were run in PubMed, US FDA and INAHTA database while additional articles were retrieved from reviewing the bibliographies of retrieved articles. The search was limited to articles on human. There was no language limitation in the search. The last search was conducted on 22nd March 2021.

Authors' identified further research: -

Project Status: Completed

Year Published: 2021

URL for published report: https://www.moh.gov.my/index.php/database_stores/store_view_page/30/376

Requestor: Decision-making committee

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)