The del Nido versus cold blood cardioplegia in aortic valve replacement: A randomized trial

Sanetra, Krzysztof; Gerber, Witold; Shrestha, Rajendra; Domaradzki, Wojciech; Krzych, Łukasz J.; Zembala, Marian; Cisowski, Marek

doi:10.1016/j.jtcvs.2019.05.083

Cited by 62 publications

(83 citation statements)

References 26 publications

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“…Their study however was not powered to detect such a difference. 13 Similarly, safety and potential advantages of DNC in adult cardiac surgery has been reported in several observational studies. [5][6][7][8][9][10][11] In a large systematic review and meta-analysis included more than 2000 patients (mostly isolated CABG and single valve procedures), An et al found no difference between DNC and BC in mortality or major morbidity.…”

Section: Discussionmentioning

confidence: 81%

“…Finally, we reported only short-term outcomes and weather DNC is associated with any potential long-term benefits is unknown. 11 (7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19) 9 (7)(8)(9)(10)(11)(12)(13)(14) .10…”

Section: Limitationsmentioning

confidence: 99%

“…1 Presently, del Nido Cardioplegia (DNC) is routinely used in pediatric cardiac surgery with excellent outcomes [2][3][4] Several studies confirmed the safety of DNC in selected adult cardiac surgery procedures. [5][6][7][8][9][10][11][12][13] However, these studies included mostly selected and relatively simple adult cardiac surgery procedures such as first time CABG or single valve surgery. Indeed, studies on routine use of DNC for all categories of adult cardiac surgery including more complex procedures with intermediate or high risk profile patients are limited.…”

Section: Introductionmentioning

confidence: 99%

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Routine use of del Nido Cardioplegia compared to blood cardioplegia in all types of adult cardiac surgery procedures

Algarni

2020

Preprint

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Background and aim of the study: Several studies reported safety and potential benefits of single dose Del Nido cardioplegia (DNC) in selected Adult Cardiac Surgery (ACS) procedures. However, studies are scarce on routine use of DNC in more complex procedures and patients with high risk profile. We sought to compare DNC with cold blood cardioplegia (BC) in all types of ACS including complex procedures. Methods: Data for 305 consecutive unselected patients who underwent ACS procedures (July/2017 to Nov/2019) were included. DNC was routinely used whenever is available (n=231) and if not available, cold BC is used (n=74). All categories of ACS procedures (primary or redo) were included. Repeated measures analysis was performed to compare baseline, peak and trough Troponins levels in both groups. Linear regression analysis was used to identify independent predictors of peak Troponins level. Results: The two groups were comparable in baseline characteristics including euro score (ES II), risk profile and surgical complexity. DNC was associated with lower cardiopulmonary bypass (CPB) and cross clamp times, cardioplegia volume and number of cardioplegia doses (P<.001). Importantly, DNC was associated with lower postoperative Troponin level (P=.001), shorter duration of inotropic support (P=.02) and shorter intensive care unit stay (P=.04). On linear regression analysis, DNC was an independent predictor of lower postoperative peak Troponin (t =-3.5, P<.001). Conclusions: Routine use of DNC in all types of ACS procedures compared to BC was associated with significantly shorter CPB and clamp times, significantly lower post-operative troponin release and shorter duration of inotropic support.

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Section: Discussionmentioning

confidence: 81%

Section: Limitationsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Routine use of del Nido Cardioplegia compared to blood cardioplegia in all types of adult cardiac surgery procedures

Algarni

2020

Preprint

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“…Recently, two prospective studies assessing the effects of DNS in adults have been published [ 10 , 11 ], yet their primary outcomes focused on myocardial protection indirectly or on biochemical data (ie, electrical activity, need for ventricular defibrillation after the release of the aortic cross-clamp, and troponin evolution after surgery). Light has yet to be shed on the clinical advantages of DNS in adult patients, including older patients and those with a history of ventricular dysfunction.…”

Section: Introductionmentioning

confidence: 99%

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

Suárez¹,

Fernández²,

Sanz³

et al. 2020

JMIR Res Protoc

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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

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“…Thus, the clinical results in this single-center series are consistent with published series by Mick and colleagues 1 and Ad and colleagues 2 demonstrating the equivalence or superiority of del Nido to blood cardioplegia. 3 The impact on intraoperative blood glucose management and crystalloid requires management. However, the convenience factor (single administration) allows the surgeon to focus on the procedure and not on cardioplegia administration.…”

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confidence: 99%

Commentary: del Nido versus blood cardioplegia for aortic valve replacement: The choice is yours. Proceed with caution

Shemin¹

2020

The Journal of Thoracic and Cardiovascular Surgery

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Cold blood versus del Nido solutions and techniques of administration require continued investigation. Central Message This study with the accumulating clinical evidence continues to demonstrate the equivalent degree of myocardial protection for del Nido solution compared with cold blood cardioplegia. The exposure to subsets of patients with low EF and requiring complex surgery requires broader clinical experience.

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The del Nido versus cold blood cardioplegia in aortic valve replacement: A randomized trial

Cited by 62 publications

References 26 publications

Routine use of del Nido Cardioplegia compared to blood cardioplegia in all types of adult cardiac surgery procedures

Routine use of del Nido Cardioplegia compared to blood cardioplegia in all types of adult cardiac surgery procedures

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

Commentary: del Nido versus blood cardioplegia for aortic valve replacement: The choice is yours. Proceed with caution

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