scholarly journals Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Jessica Garcia-Suarez ◽  
Javier Garcia Fernandez ◽  
Sergio Sanz ◽  
Daniel Martinez Lopez ◽  
Leticia Reques ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Myocardial Protection ◽  
Primary Outcome ◽  
Retrospective Studies ◽  
Adult Patients ◽  
Blood Cardioplegia ◽  
Cardioplegia Solution ◽  
Adult Cardiac Surgery

BACKGROUND The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients. OBJECTIVE The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery. METHODS This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable <i>acute cardiovascular event</i>). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions. RESULTS The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021. CONCLUSIONS This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures. CLINICALTRIAL European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17826

scholarly journals Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial

10.2196/17826 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e17826
Author(s):  
Jessica Garcia-Suarez ◽  
Javier Garcia Fernandez ◽  
Sergio Sanz ◽  
Daniel Martinez Lopez ◽  
Leticia Reques ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Myocardial Protection ◽  
Primary Outcome ◽  
Retrospective Studies ◽  
Adult Patients ◽  
Blood Cardioplegia ◽  
Cardioplegia Solution ◽  
Adult Cardiac Surgery

Background The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients. Objective The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery. Methods This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions. Results The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021. Conclusions This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures. Trial Registration European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168 International Registered Report Identifier (IRRID) DERR1-10.2196/17826

Myocardial protection following del Nido cardioplegia in pediatric cardiac surgery

2018 ◽  
Vol 26 (4) ◽  
pp. 267-272 ◽  
Author(s):  
Debasish Panigrahi ◽  
Saibal Roychowdhury ◽  
Rahul Guhabiswas ◽  
Emmanuel Rupert ◽  
Mrinalendu Das ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Creatine Kinase ◽  
Cardiac Surgery ◽  
Intensive Care ◽  
Cardiopulmonary Bypass ◽  
Myocardial Protection ◽  
Troponin I ◽  
Blood Cardioplegia ◽  
Cardioplegia Solution ◽  
Creatine Kinase Mb

Background This study was designed to compare myocardial protection with del Nido cardioplegia and conventional blood cardioplegia in children undergoing cardiac surgery in Risk Adjustment for Congenital Heart Surgery categories 1 and 2. Methods Sixty patients were randomized into 2 groups receiving del Nido cardioplegia solution or conventional blood cardioplegia. Myocardial injury was assessed using biochemical markers (troponin I and creatine kinase-MB). Vasoactive-inotropic scores were calculated to compare inotropic requirements. Results Demographic characteristics, cardiopulmonary bypass time, and aortic crossclamp time were comparable in the 2 groups. Time-related changes in troponin I and creatine kinase-MB were similar in both groups. Statistically significant differences were seen in total cardioplegia volume requirement ( p < 0.0001), number of cardioplegia doses given ( p < 0.0001), packed red cell volume usage during cardiopulmonary bypass ( p < 0.02), and time taken to restore spontaneous regular rhythm ( p < 0.0001). Vasoactive-inotropic scores on transfer to the intensive care unit ( p < 0.040) and at 24 h ( p < 0.030) were significantly lower in the del Nido group. Duration of mechanical ventilation, intensive care unit stay, and hospital stay were comparable in the 2 groups. Conclusions Our results show that del Nido cardioplegia solution is as safe as conventional blood cardioplegia. Moreover, it provides the benefits of reduced dose requirement, lower consumption of allogenic blood on cardiopulmonary bypass, quicker resumption of spontaneous regular cardiac rhythm, and less inotropic support requirement on transfer to the intensive care unit and at 24 h, compared to conventional blood cardioplegia.

scholarly journals Del Nido versus warm blood cardioplegia in adult patients with a low ejection fraction

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Amr A. Arafat ◽  
Essam Hassan ◽  
Juan J. Alfonso ◽  
Ebtesam Alanazi ◽  
Ahmad S. Alshammari ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Ejection Fraction ◽  
Hospital Stay ◽  
Adult Patients ◽  
Blood Cardioplegia ◽  
Warm Blood ◽  
Multivariable Regression ◽  
Warm Blood Cardioplegia ◽  
Low Ejection Fraction

Abstract Background Del Nido cardioplegia was recently introduced to adult cardiac surgery with encouraging results. The effect of Del Nido cardioplegia in patients with low ejection fraction (EF) has not been thoroughly evaluated. The objective of this study was to assess the safety of Del Nido cardioplegia in adult patients with low EF compared to intermittent warm blood cardioplegia. Results During 2018 and 2019, 73 adult patients with an EF of ≤ 40% underwent cardiac surgery using Del Nido cardioplegia. The patients were compared to a historical cohort of consecutive patients with low EF who had intermitted warm blood cardioplegia (n = 81). Patients who had Del Nido cardioplegia had significantly lower EuroSCORE II (2.73 (1.7–4.1) vs. 4.5 (2.4–7.4), P = 0.004). There were no differences in creatinine clearance and preoperative echocardiographic data between the groups. Cardiopulmonary bypass and cross-clamp times were non-significantly lower with Del Nido cardioplegia. There were no differences in stroke and postoperative echocardiographic data between the groups. No hospital mortality was reported in both groups. Peak troponin levels were significantly higher in patients who had Del Nido cardioplegia (0.88 (0.58–1.47) vs. 0.7 (0.44–1.01) ng/dL; P = 0.01); however, after multivariable regression analysis, cardiopulmonary bypass time was the only predictor of postoperative troponin level (coefficient 0.005 (95% CI: 0.003–0.008); P < 0.001). ICU stay was significantly longer in patients who had Del Nido cardioplegia (4 (3–6) vs. 2(1–4) days, P < 0.001), while postoperative hospital stay did not differ between the groups. After multivariable regression, the use of intermittent warm blood cardioplegia was significantly associated with shorter ICU stay (coefficient − 1.80 (95% CI − 3.06 – -0.55); P = 0.01). Conclusions Prolonged ICU was reported with Del Nido cardioplegia; however, there were no differences in the duration of hospital stay and the clinical outcomes between the groups. Despite the proven efficacy of intermittent warm blood cardioplegia, the use of Del Nido cardioplegia might be safe in patients with low EF.

scholarly journals Myocardial Protection by Blood-Based Del Nido versus St. Thomas Cardioplegia in Cardiac Surgery for Adults and Children

2020 ◽  
Vol 23 (5) ◽  
pp. E689-E695
Author(s):  
Ahmed Abdelrahman Elassal ◽  
Kkalid Al-Ebrahim ◽  
Osman Al-Radi ◽  
Zaher Faisal Zaher ◽  
Ahmed Mohamed Dohain ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Clinical Outcome ◽  
Myocardial Protection ◽  
Adult Patients ◽  
University Hospital ◽  
Surgical Workflow ◽  
Significant Difference ◽  
Inotropic Score ◽  
Adults And Children ◽  
Adult Cardiac Surgery

Background: St. Thomas (ST) and Del Nido (DN) cardioplegic solutions are widely used for myocardial protection during cardiac surgery. In 2016, our university hospital shifted from modified St. Thomas to Del Nido solution for both adult and pediatric cardiac surgery. This retrospective study was conducted to compare ST and DN solutions regarding surgical workflow and clinical outcome in pediatric and adult patients undergoing cardiac surgery. Methods: We reviewed 220 patients who underwent cardiac surgery requiring cardioplegic arrest. Patients were categorized in 2 groups: ST (n = 110) and DN (n = 110). Each group included 60 pediatric and 50 adult patients. Demographic, intraoperative, and postoperative variables were collected. Results: In pediatric patients, no significant difference was found between the 2 groups regarding clamping time, bypass time, need for defibrillation, inotropic score, postoperative ejection fraction (EF), period of mechanical ventilation, intensive care unit stay, or postoperative arrhythmias. One patient in the ST group required mechanical support by extracorporeal membrane oxygenation. We had 5 cases of pediatric mortality (3 in DN and 2 in ST, P = .64). In adult patients, significantly fewer patients in the DN group needed defibrillation than in the ST group. No significant difference was found regarding clamping time, inotropic score, or intraaortic balloon pump use. Mortality in adult patients was 6 cases (4 in ST group and 2 in DN group). Conclusion: DN cardioplegia solution is as safe as ST solution in pediatric and adult cardiac surgery. It has comparable results of myocardial protection and clinical outcome, with superiority regarding uninterrupted surgery and lower rate of defibrillation.

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