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 ◽  
...  

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.

10.2196/17826 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e17826
Author(s):  
Jessica Garcia-Suarez ◽  
Javier Garcia Fernandez ◽  
Sergio Sanz ◽  
Daniel Martinez Lopez ◽  
Leticia Reques ◽  
...  

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


2020 ◽  
Vol 47 (2) ◽  
pp. 108-116
Author(s):  
Taylor M. James ◽  
Marcos Nores ◽  
John A. Rousou ◽  
Nicole Lin ◽  
Sotiris C. Stamou

Warm blood cardioplegia has been an established cardioplegic method since the 1990s, yet it remains controversial in regard to myocardial protection. This review will describe the physiologic and technical concepts behind warm blood cardioplegia, as well as outline the current basic and clinical research that evaluates its usefulness. Controversies regarding this technique will also be reviewed. A long history of experimental data indicates that warm blood cardioplegia is safe and effective and thus suitable myocardial protection during cardiopulmonary bypass surgeries.


2013 ◽  
Vol 17 (suppl 2) ◽  
pp. S106-S106
Author(s):  
K. Trescher ◽  
A. Gleiss ◽  
M. Boxleitner ◽  
W. Dietl ◽  
H. Kassal ◽  
...  

2020 ◽  
Author(s):  
Jessica Garcia-Suarez ◽  
Javier Garcia Fernandez ◽  
Sergio Sanz ◽  
Daniel Martinez Lopez ◽  
Leticia Reques ◽  
...  

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


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