ABSTRACT
Background: Myocardial protection is crucial for successful cardiac surgery, as it prevents heart muscle damage that can occur during the procedure. Prolonged hypoxia without proper protection can lead to adenosine triphosphate consumption, microvilli loss, blister formation, and edema. Custodiol, del Nido, and modified del Nido are single-dose cardioplegic solutions with proven safety and significance in modern surgery. While each has been independently assessed for patient outcomes, limited research directly compares them. This study aims to compare their myocardial protection using histological analysis. Methods: In a double-blind clinical trial, at least 90 patients will be randomly assigned to receive one of the three cardioplegic solutions. Myocardial biopsies will be collected before cardiopulmonary bypass and 15 minutes after reperfusion. The surgical, anesthetic and perfusion techniques will be the same for all patients, following the Institution's standard protocols. Discussion: The ideal cardioplegic solution does not exist, and its selection remains challenging for surgeons. In modern surgical practice, understanding the behavior of these solutions and the ischemic tissue damage caused during induced cardiac arrest allows for safer surgical procedures. The results of this clinical trial can help in understanding the behavior of cardioplegic solutions and their tissue effects. Thus, by selecting the best cardioplegic solution, ischemic damage can be minimized, enhancing the effectiveness of this essential technique in cardiac procedures. The study may aid in implementing clinical protocols in several institutions, aiming to choose the solution with a superior myocardial protection profile, increasing safety, and reducing expenses. Trial Registration: Brazilian Clinical Trials Registry (ReBEC, http://ensaiosclinicos.gov.br/): RBR-997tqhh. Registered: January 26th, 2022.
ABSTRACT
Objective: To assess the potential benefits of minimally invasive aortic valve replacement (MIAVR) compared with conventional AVR (CAVR) by examining short-term outcomes. Methods: A systematic search identified randomized trials comparing MIAVR with CAVR. To assess study limitations and quality of evidence, we used the Cochrane Risk of Bias tool and GRADE and performed random-effects meta-analysis. We used meta-regression and sensitivity analysis to explore reasons for diversity. Results: Thirteen studies (1,303 patients) were included. For the comparison of MIAVR and CAVR, the risk of bias was judged low or unclear and the quality of evidence ranged from very low to moderate. No significant difference was observed in mortality, stroke, acute kidney failure, infectious outcomes, cardiac events, intubation time, intensive care unit stay, reoperation for bleeding, and blood transfusions. Blood loss (mean difference [MD] = -130.58â mL, 95% confidence interval [CI] = -216.34 to -44.82, I2 = 89%) and hospital stay (MD = -0.93 days, 95% CI = -1.62 to -0.23, I2 = 81%) were lower with MIAVR. There were shorter aortic cross-clamp (MD = 5.99â min, 95% CI = 0.99 to 10.98, I2 = 93%) and cardiopulmonary bypass (CPB) times (MD = 7.75â min, 95% CI = 0.27 to 15.24, I2 = 94%) in the CAVR group. In meta-regression analysis, we found that age was the variable with the greatest influence on heterogeneity. Conclusions: MIAVR seems to be an excellent alternative to CAVR, reducing hospital stay and incidence of hemorrhagic events. Despite significantly greater aortic cross-clamp and CPB times with MIAVR, this did not translate into adverse effects, with no changes in the results found with CAVR.
Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Humans , Minimally Invasive Surgical Procedures/methods , Treatment OutcomeABSTRACT
INTRODUCTION: Myocardial protection is essential for successful cardiac surgery, and the search for an ideal cardioplegic solution has continued since its beginning. In this context, Custodiol, del Nido and modified del Nido are single-dose cardioplegic solutions with good safety profiles and great relevance in modern surgical practice. While these solutions have all been evaluated for their impact on patient outcomes independently, limited research exists comparing them directly. Thus, the present study aims to examine the effects of these cardioplegic solutions on myocardial protection and clinical outcomes in adult patients undergoing elective cardiac surgery. The assessment of the increase in myocardial injury biomarkers in patients submitted to all treatment methods may be considered a major strength of our study. METHODS AND ANALYSIS: This is a clinical trial study protocol that will compare myocardial protection and clinical outcomes among three patient groups based on which cardioplegic solution was used. Patients will be randomised to receive del Nido (n=30), modified del Nido (n=30) or Custodiol (n=30). Myocardial injury biomarkers will be measured at the baseline and 2 hours, 12 hours and 24 hours after the cardiopulmonary bypass. Clinical outcomes will be assessed during the trans operative period and the intensive care unit stay, in addition to other haematological parameters. ETHICS AND DISSEMINATION: This protocol and its related documents were approved by the Research Ethics Committee of the Hospital Nossa Senhora da Conceição, Brazil, registered under no. 4.029.545. The findings of this study will be published in a peer-reviewed journal in the related field. TRIAL REGISTRATION NUMBER: RBR-7g5s66.