Crystalloid cardioplegia versus cold blood cardioplegia in aortic arch surgery: A noninferiority randomized trial

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Elective aortic arch replacement (n=52). Intervention: Cold crystalloid cardioplegia vs. Cold blood cardioplegia. Primary outcome: Left ventricular ejection fraction (LVEF) on postoperative day 7 (MD 1.23%, 95% CI -2.89 to 4.12, p=0.0041 for noninferiority).

Q: What does this research mean for the field?

Cold crystalloid cardioplegia is noninferior to cold blood cardioplegia in preserving postoperative left ventricular ejection fraction in patients undergoing elective aortic arch surgery. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Shota Hasegawa; Katsuhiro Yamanaka; Ryo Kawabata; Hironaga Shiraki; Shunya Chomei; Noriko Ohyama; Taishi Inoue; Soichiro Henmi; Hiroaki Takahashi; Kenji Okada

doi:10.1016/j.xjon.2026.101578

January 8, 2026JTCVS OpenOpen Access

Crystalloid cardioplegia versus cold blood cardioplegia in aortic arch surgery: A noninferiority randomized trial

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Key result

Cold crystalloid cardioplegia matches cold blood cardioplegia for preserving postoperative LVEF.

MD +1.23%
95% CI -2.89 to 4.12
P=0.0041 for noninferiority
n=52

Figures

Why the study?

The optimal cardioplegic solution to use during aortic surgery remains unclear, as cold blood cardioplegia offers metabolic advantages while crystalloid cardioplegia offers practical benefits.

Does cold crystalloid cardioplegia provide noninferior preservation of postoperative left ventricular ejection fraction compared to cold blood cardioplegia in adult patients undergoing elective aortic arch replacement?

Study Design

Type

RCT (n=52)

Blinding

Double-blind

Randomization

Permuted block method (1:1 ratio, block size of 4)

Multicenter

No

Structured PICO

Does cold crystalloid cardioplegia provide noninferior preservation of postoperative left ventricular ejection fraction compared to cold blood cardioplegia in adult patients undergoing elective aortic arch replacement?

P

Population

52 adult patients (median age 75, 44% female) with preoperative LVEF >50% undergoing elective aortic arch replacement, assessed for preservation of cardiac function over a 7-day postoperative period.

I

Intervention

Cold crystalloid cardioplegia (CCP) consisting of 10 mL/kg of St. Thomas’ Hospital II solution (Miotector) containing 2 mg of lidocaine per 10 mL/kg at 4 °C. Delivered anterogradely at 60 minutes and retrogradely at 30 minutes.

C

Comparator

Cold blood cardioplegia (BCP) consisting of a mixture of autologous blood and crystalloid in a 4:1 ratio at 12 °C. Dose was 10 mL/kg (minimum 500 mL) administered initially, with additional doses every 35 minutes or if electrical activity was observed, plus terminal warm BCP before aortic declamping.

O

Outcome

Left ventricular ejection fraction (LVEF) measured by transthoracic echocardiography on postoperative day 7.surrogate

Main Result

Mean Difference: 1.23 (95% CI -2.89–4.12)

Absolute Event Rate: 59.5% vs 58.3%

p-value: p=0.0041 for noninferiority

Cold crystalloid cardioplegia offers a practical and similarly effective alternative to cold blood cardioplegia for preserving left ventricular function following elective aortic arch surgery requiring prolonged ischemia.

Limitations

Single-center trial with a relatively small sample size
Underpowered to assess secondary outcomes and infrequent clinical events
Heterogeneity in operative procedures, including variations in the extent of arch repair
Surgeons were not blinded to the assigned cardioplegia
Outcome assessments were restricted to the early postoperative period
single-center trial
relatively small sample size
underpowered for evaluating secondary outcomes and uncommon clinical events
heterogeneity in operative procedures (extent of arch repair, proportion of concomitant aortic valve replacements)
surgeons were not blinded to the assigned cardioplegia
outcome assessments were restricted to the early postoperative period

Implication

Crystalloid cardioplegia offers a practical alternative in aortic arch replacement; confirms noninferiority to blood cardioplegia for LVEF preservation.

Abstract

Background: The optimal cardioplegic solution to use during aortic surgery remains unclear. While cold blood cardioplegia (BCP) has metabolic advantages, crystalloid cardioplegia (CCP) offers practical benefits. This trial investigated whether cold CCP is noninferior to cold BCP in preserving postoperative left ventricular ejection fraction (LVEF). Methods: In this single-center, patient- and assessor-blinded, parallel-group noninferiority randomized trial, 52 adult patients undergoing elective aortic arch replacement were randomized 1:1 to receive cold BCP or CCP. The primary endpoint was LVEF on postoperative day 7. The noninferiority margin was set at -7%. Secondary endpoints included change in LVEF, mortality, low-output syndrome, myocardial infarction (MI), creatine kinase MB isotype (CK-MB) release, left ventricular diastolic dysfunction, right ventricular systolic dysfunction, stroke, atrial fibrillation, pacemaker implantation, mediastinal drainage, reexploration for bleeding, and acute kidney injury. Results: = .034 and .046, respectively). One in-hospital death occurred in the BCP group, and 1 case of low output syndrome occurred in the CCP group. Postoperative MI occurred in 4 patients (2 per group), with no significant differences in other secondary endpoints. Conclusions: Cold CCP appeared to be noninferior to cold BCP for myocardial protection in elective aortic arch replacement, as suggested by comparable postoperative LVEF.

Discussion

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Cite This Study

Hasegawa et al. (2026) conducted an RCT in Elective aortic arch replacement (n=52). Cold crystalloid cardioplegia vs. Cold blood cardioplegia was evaluated on Left ventricular ejection fraction (LVEF) on postoperative day 7 (MD 1.23%, 95% CI -2.89 to 4.12, p=0.0041 for noninferiority). Cold crystalloid cardioplegia preserved postoperative left ventricular ejection fraction as effectively as cold blood cardioplegia (mean difference 1.23%), meeting the predefined noninferiority margin of -7%.

synapsesocial.com/papers/6a07ebcd686e45fdbcfe095f https://doi.org/10.1016/j.xjon.2026.101578

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Crystalloid cardioplegia versus cold blood cardioplegia in aortic arch surgery: A noninferiority randomized trial

Figures

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Crystalloid cardioplegia versus cold blood cardioplegia in aortic arch surgery: A noninferiority randomized trial

Figures

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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