Dataset Information

Assessing sex-based differences in postsurgical clinical outcomes after use of del Nido cardioplegia.

ABSTRACT:

Objectives

del Nido cardioplegia is used to pharmacologically arrest the heart during cardiac surgery and decrease reperfusion- and ischaemia-related myocardial injury. Studies have demonstrated the physiological differences between male and female hearts, potentially related to cardiac size or myocyte calcium handling; we aimed to assess for between-sex differences in clinical outcomes after receipt of del Nido cardioplegia.

Methods

Patients who underwent coronary artery bypass or coronary artery bypass graft/valve surgery at our institution using del Nido cardioplegia (January 2014 to December 2019) were included (n = 2118). Clinical data were collected retrospectively. After the creation of a propensity-matched cohort (n = 1252), multivariable logistic regression was used to analyse binary postoperative outcomes, and a Gamma model was used for a continuous postoperative outcome. Our primary end-point was a composite end-point comprised of 30-day mortality and/or need for a post-bypass mechanical support device.

Results

The final cohort included 459 females and 793 males (matched up to 1:2, all standardized mean differences <0.1). Multivariable logistic regression showed that biological sex was not associated with the composite primary end-point (odds ratio = 0.898, P = 0.779). A Gamma model indicated that there were no sex-related differences in vasoactive-inotropic scores reflecting vasopressor and inotrope usage at the time of patient operating room exit (exp[est] = 1.394, P = 0.189).

Conclusions

Our findings showed no significant between-sex differences in clinical outcomes after receiving del Nido cardioplegia, suggesting adequate myocardial protection as currently administered. Further research is warranted to elicit if there are sex-based differences between cardioplegic solutions.

Irb approval date (protocol number)

26 May 2021 (AAAR8359).

SUBMITTER: Honzel E

PROVIDER: S-EPMC9531685 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Assessing sex-based differences in postsurgical clinical outcomes after use of del Nido cardioplegia.

Honzel Emily E Nemeth Samantha S Kazzi Brigitte E BE Kossar Alexander P AP Sun Jocelyn J Kaku Yuji Y Takeda Koji K Takayama Hiroo H Argenziano Michael M Spellman Jessica J Miltiades Andrea A Fung Kenmond K Beck James J Smith Craig R CR Kurlansky Paul P George Isaac I

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 20221001 5

<h4>Objectives</h4>del Nido cardioplegia is used to pharmacologically arrest the heart during cardiac surgery and decrease reperfusion- and ischaemia-related myocardial injury. Studies have demonstrated the physiological differences between male and female hearts, potentially related to cardiac size or myocyte calcium handling; we aimed to assess for between-sex differences in clinical outcomes after receipt of del Nido cardioplegia.<h4>Methods</h4>Patients who underwent coronary artery bypass o ...[more]

PMID: 36165688

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Project description:Background:To analyze the protective effect of single-dose del Nido cardioplegia (DNC) in adult minimally invasive valve surgery. Methods:From January to December 2017, 165 consecutive adult patients who underwent minimally invasive valve surgery by the same team of surgeons were divided into two cohorts based on the type of cardioplegia administered during surgery: (I) single-dose DNC (DNC group (n=76, male 41, female 35) used in patients from May to December, 2017 and (II) intermittent standard 4:1 blood cardioplegia based on St.Thomas solution (SBC group, n=89, male 45, female 44) used in patients from January to April, 2017. Preoperative baseline demographics, preoperative comorbidities, operative variables, postoperative complications, and patient outcomes were collected and compared between the two groups. Results:Preoperative characteristics were shown to be similar between the two groups before and after propensity matching. Patients in the DNC group required a significantly lower volume of cardioplegia. The volume of ultrafiltration in the DNC group was substantially higher than that in the SBC group. The spontaneous return of heartbeat rate in the DNC group was considerably higher than that in the SBC group (97.0% vs. 78.8%, P=0.006). The Euroscore II in the DNC group was markedly lower than that in the SBC group (2.00 vs. 3.00, P<0.05). The level of blood urea nitrogen (BUN) in the DNC group was significantly lower than that in the SBC group (6.20 vs. 6.95, P<0.05). There were no differences in surgery procedure, cross-clamp time, bypass time, Apache score, troponin T (cTnT), brain natriuretic peptide (BNP), liver and renal function, postoperative complications or patient outcomes between two groups. Regression analysis showed that cTnT increased with the prolongation of myocardial ischemia time, and was closely related to the type of operation, but had no significant correlation with the type of cardioplegia. Conclusions:In our initial experience, single-dose DNC in adult minimally invasive valve surgery in which the cross-clamp time was mostly less than 90 min, achieved equivalent myocardial protection and clinical outcomes when compared with standard whole blood cardioplegia. In addition, single-dose DNC made the minimally invasive valve surgery procedure progress in a smoother and more convenient fashion.

Project description:BackgroundThe 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.ObjectiveThe 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.MethodsThis 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.ResultsThe 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.ConclusionsThis 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 registrationEuropean 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.

Project description:BackgroundDel Nido cardioplegia (DNC) has extensively been used for pediatric population undergoing cardiac surgery. However, its use in adult cardiac surgeries have been limited thus, its benefits are not yet fully known. This analysis was performed to evaluate the impact of DNC versus any other type of cardioplegia in adult patients who are undergoing cardiac surgery.MethodsWe systematically searched PubMed, Cochrane Library, and Scopus from database inception till March 2023, and moderate to high-quality randomized controlled trials were included which compared DNC to other cardioplegia. The primary outcome was postoperative stroke and/or transient ischemic attack (TIA). Secondary outcomes included spontaneous rhythm return, postoperative myocardial infarction, all-cause mortality, postoperative atrial fibrillation, defibrillation after coronary reperfusion, postoperative intra-aortic balloon pump, postoperative kidney injury, postoperative low cardiac output syndrome, inotropic support, cardiopulmonary bypass time, cross-clamp time, blood transfusion, cardioplegia volume, hospital stay, intensive care unit stay, mechanical ventilation stay, postoperative left ventricular ejection fraction, and cardiac markers.ResultsIn this meta-analysis, 13 studies were included with a patient population of 2207. Stroke and/or TIA studies (risk ratio [RR]: 0.54, 95% CI [0.29, 1.00]) and all-cause mortality studies (RR: 1.30, 95% CI [0.66, 2.56]) were insignificant. From the secondary outcomes, spontaneous rhythm return (RR: 1.58, 95% CI [1.02, 2.45]), defibrillation after coronary reperfusion (RR: 0.49, 95% CI [0.30, 0.79]), inotropic support (RR: 0.70, 95% CI [0.57, 0.85]), composite risk of stroke and/or TIA and/or acute kidney injury and mortality (RR: 0.72, 95% CI [0.53, 0.99]), cross-clamp time (mean difference [MD]: -6.01, 95% CI [-11.14, -0.89]), blood transfusion (RR: 0.73, 95% CI [0.60, 0.90]), cardioplegia volume (MD: -537.17, 95% CI [-758.89, -315.45]), troponin T (MD: -1.71, 95% CI [-2.11, -1.32]), creatine phosphokinase-MB (MD: -2.96, 95% CI [-5.84, -0.07]) were significant. Whereas all other secondary outcomes were found to be insignificant.ConclusionNo significant difference was observed between patients undergoing Del Nido administration in comparison to other cardioplegia solutions for the primary outcome, stroke or/and TIA.

Dataset Information

Assessing sex-based differences in postsurgical clinical outcomes after use of del Nido cardioplegia.

Objectives

Methods

Results

Conclusions

Irb approval date (protocol number)

Publications

Assessing sex-based differences in postsurgical clinical outcomes after use of del Nido cardioplegia.

Similar Datasets

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