Custodiol versus Plegisol: A phase 3 multicentre myocardial protection study

Demmy, Todd L.; Molina, J. Ernesto; Ward, Herbert B.; Gorton, Michael E.; Kouchoukos, Nicholas T.; Schmaltz, Richard A.; Shennib, Hani

doi:10.1055/s-0031-1278300

Cited by 21 publications

(16 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…On the other hand, time to cardiac arrest in our study was of about 60 seconds for both groups, whereas ACC time was about 40-50 min. Demmy et al 13 demonstrated lower defibrillation rate after ACC (64% vs. 91%), but a significantly higher peak level of cTnI 6 hours after surgery in the HTK group (no information about ACC time was given) . Hamed et al 14 , in a study with ACC time mean value of about 60 minutes showed that St. Thomas cardioplegia was comparable to HTK and blood cardioplegia in pediatric cardiac surgery.…”

Section: Summarized Factors Of Perioperative Myocardial Injurymentioning

confidence: 99%

Comparison of Custodiol® and modified St. Thomas cardioplegia for myocardial protection in coronary artery bypass grafting

et al. 2020

View full text Add to dashboard Cite

Background/Aim. Custodiol is a hyperpolarizing cardioplegic solution which has been used in our national cardiac surgical practice exclusively for the heart transplant surgery. Owing to its numerous advantages over the standard depolarizing solutions, Custodiol became cardioplegia of choice for all other cardiac surgical procedures in many cardiosurgical centers. This study evaluates myocardial protection of Custodiol compared to modified St. Thomas cardioplegia in coronary artery bypass surgery. Methods. In a prospective four-month study 110 consecutive adult patients who underwent primary isolated elective on-pump coronary artery bypass grafting (CABG) were randomized into Custodiol group (n=54) and modified St.Thomas group (n=50), based on the type of administered cardioplegia; six patients were excluded. Cardiac protection was achieved as antegrade cold crystalloid cardioplegia by one of the solutions. Myocardial preservation was assessed through following outcomes: spontaneous rhythm restoration post crossclamp, and postpoperative cardiac specific enzymes level, ejection fraction (EF) change, inotropic support, myocardial infarction (MI), atrial fibrillation (AF), and death. Results. Preoperative and intraoperative characteristics were similar except for a considerably longer cross-clamp time in the Custodiol group (49.1±19.0 vs. 41.0±12.9 minutes; p=0.022). Custodiol group exhibited a higher rate of return to spontaneous rhythm (31.5% vs. 20.0%; p=0.267), lower rates of AF (20.4% vs. 28%; p=0.496), MI (1.8% vs. 10.0%; p=0.075) and inotropic support (9.0% vs. 12.0%; p=0.651), albeit not statistically significant. There was an insignificant difference in peak value of Troponin I (5.0±3.92µg/L vs. 4.5±3.39µg/L; p=0.755) and Creatine Kinase-MB (26.9±15,4µg/L vs. 28.5±24.2µg/L; p=0,646) 6 hours post-surgery. EF reduction was comparable (0,81% vs. 1.26%; p=0.891). There were no deaths. Conclusions. Custodiol and modified St.Thomas cardioplegia have comparable cardioprotective effects in CABG surgery. The trends of less frequent MI, AF and inotropic support, despite the longer cross-clamp time in the Custodiol group may suggest that its benefits could be ascertained in a larger study. ApstraktUvod/Cilj. Custodiol je hiperpolari iraju i kardiolegi ni rastvor koji je kori en, u na oj nacionalnoj kardiohirur koj praksi, isklju ivo u transplantacionoj hirurgiji. Zbog svojih brojnih prednosti u odnosu na standarde, depolari iraju e rastvore, Custodiol je, u mnogim kardiohirur kim centrima, postao kardioplegija i bora a sve kardiohirur ke procedure. Cilj studije je procena miokardne protekcije rastvorom Custodiol-a u poređenju sa modifikovanom St. Thomas kardioplegijom u koronarnoj hirurgiji. Metode. Tokom prospektivne etveromese ne studijie, 110 u astopnih odraslih pacijenata podvrgnutih primarnoj, izolovanoj, elektivnoj operaciji aortokoronarnog bajpas su randomizirani na osnovu primenjene kardioplegije u Custodiol grupu (n=54) i modifikovanu St.Thomas

show abstract

Section: Summarized Factors Of Perioperative Myocardial Injurymentioning

confidence: 99%

Comparison of Custodiol® and modified St. Thomas cardioplegia for myocardial protection in coronary artery bypass grafting

et al. 2020

View full text Add to dashboard Cite

show abstract

“…In addition, other solutions with no oncotic agent have been formulated such as Celsior and histidine-tryptophan-ketoglutarate (HTK), which are used for liver transplantation [ 25 , 26 ]. Table 1 summarizes the differences between the organ preservation solutions [ 27 , 28 , 29 ].…”

Section: Unfolded Protein Response (Upr)/ers In Liver Graft Presermentioning

confidence: 99%

Relevance of Endoplasmic Reticulum Stress Cell Signaling in Liver Cold Ischemia Reperfusion Injury

Folch-Puy

Panisello

Oliva

et al. 2016

IJMS

View full text Add to dashboard Cite

The endoplasmic reticulum (ER) is involved in calcium homeostasis, protein folding and lipid biosynthesis. Perturbations in its normal functions lead to a condition called endoplasmic reticulum stress (ERS). This can be triggered by many physiopathological conditions such as alcoholic steatohepatitis, insulin resistance or ischemia-reperfusion injury. The cell reacts to ERS by initiating a defensive process known as the unfolded protein response (UPR), which comprises cellular mechanisms for adaptation and the safeguarding of cell survival or, in cases of excessively severe stress, for the initiation of the cell death program. Recent experimental data suggest the involvement of ERS in ischemia/reperfusion injury (IRI) of the liver graft, which has been considered as one of major problems influencing outcome after liver transplantation. The purpose of this review is to summarize updated data on the molecular mechanisms of ERS/UPR and the consequences of this pathology, focusing specifically on solid organ preservation and liver transplantation models. We will also discuss the potential role of ERS, beyond the simple adaptive response and the regulation of cell death, in the modification of cell functional properties and phenotypic changes.

show abstract

“…While major adverse cardiac and cerebrovascular events were rare (with stroke being a never event in our population), mortality was reported in both investigation groups. The statistical insignificance between cardioplegia groups for mortality suggest the cause of death in each case was unrelated to the chosen cardioplegia, with authors attributing preoperative ventricular impairment, 15 postoperative low cardiac output syndrome, 16 graft thrombosis, 14 and subsequent continued infarction 13 as the cause of death in their respective populations. Previous research suggests that neither cardioplegia type nor technique are significantly influential on the incidence of myocardial ischemia following surgery, 23 and this would, therefore, support our population authors' death attributions and the statistical findings of our pooled data.…”

Section: Discussionmentioning

confidence: 99%

“…A further six studies were excluded as they were investigating pediatric cases; one study was excluded as it had a mixed population; and, three studies were excluded because they did not use HTK (Figure S1). Seven studies were included in our analysis 12‐18 …”

Section: Methodsmentioning

confidence: 99%

HTK versus multidose cardioplegias for myocardial protection in adult cardiac surgery: A meta‐analysis

Reynolds

Asopa

Modi³

et al. 2021

J Card Surg

View full text Add to dashboard Cite

Background Histidine–tryptophan–ketoglutarate (HTK) cardioplegia for myocardial protection obviates the need for maintenance cardioplegia doses, and thus allows for greater focus on procedure accuracy. The aim of this meta‐analysis is to evaluate the safety and efficacy of HTK versus multidose cardioplegias during cardiac surgery in an adult population. Methods Electronic searches were performed using PubMed, Science Direct, and Google Scholar databases. The key search terms included HTK cardioplegia AND cardiac surgery AND adult. This was followed by a meta‐analysis investigating cardiopulmonary bypass (CPB) duration, cross‐clamp duration, spontaneous defibrillation, inotropic support, mortality, atrial fibrillation, creatine kinase muscle brain band (CK‐MB) and troponin I (TnI). Results Seven randomized controlled trials (n = 804) were analyzed. Spontaneous defibrillation following aortic cross‐clamp removal significantly favored HTK (odds ratio [OR], 2.809; 95% confidence interval [CI], 1.574 to 5.012; I2 = 0%; p < .01). There were no other notable significant differences between HTK and multidose cardioplegia in any of the parameters measured. In particular, the OR for mortality was 1.237 (95% CI, 0.385 to 3.978; I2 = 0%; p = .721) and the mean difference for CPB duration overall was 2.072 min (95% CI, −2.405 to 6.548; I2 = 74%; p = .364). Conclusion HTK is safe and effective during adult cardiac surgery when compared with multidose cardioplegias for myocardial protection during surgical correction of acquired pathology in the adult population. HTK may, therefore, be suitable for complex cases or those of extensive duration, without the prospect of increased postoperative morbidity or mortality.

show abstract

Custodiol versus Plegisol: A phase 3 multicentre myocardial protection study

Cited by 21 publications

References 11 publications

Comparison of Custodiol® and modified St. Thomas cardioplegia for myocardial protection in coronary artery bypass grafting

Comparison of Custodiol® and modified St. Thomas cardioplegia for myocardial protection in coronary artery bypass grafting

Relevance of Endoplasmic Reticulum Stress Cell Signaling in Liver Cold Ischemia Reperfusion Injury

HTK versus multidose cardioplegias for myocardial protection in adult cardiac surgery: A meta‐analysis

Contact Info

Product

Resources

About