Application of mild hypothermic arch-clamping technique in the repair of DeBakey type I aortic dissection

Introduction

Acute type A aortic dissection (ATAAD) is an extremely critical cardiovascular emergency. DeBakey type I aortic dissection, due to the involvement of the ascending aorta, aortic arch, and the descending aorta distal to the arch, presents a more complex condition requiring urgent surgical intervention to save the patient’s life (1,2). Total arch replacement combined with stented elephant trunk implantation (Sun’s procedure), as the classic surgical approach for this type of lesion, has been proven to effectively improve patient prognosis and reduce the risk of long-term reoperation (3,4). However, the traditional Sun’s procedure relies on hypothermic circulatory arrest (HCA) combined with selective cerebral perfusion (SCP) techniques, which can easily induce organ ischemia-reperfusion injury. Organ protection remains a central focus of clinical research (5). Our team previously optimized the surgical process by employing an aortic arch-clamping technique under moderate HCA, reducing the circulatory arrest time to approximately 3 minutes, and significantly improved patient clinical outcomes (6-8). Recent studies have suggested that mild hypothermia (28–34 ℃) combined with SCP may provide sufficient cerebral protection when circulatory arrest is brief (9,10). Building upon this foundation, this study further adopted a mild HCA strategy, expanding the sample size to 307 cases, aiming to systematically evaluate the safety and efficacy of the mild hypothermic arch-clamping technique and provide more substantial evidence for its clinical promotion and application. We present this article in accordance with the STROBE and SUPER reporting checklists (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2026-1-0189/rc).

Methods

Study population

This study is a retrospective analysis of prospectively collected data from 307 patients with DeBakey type I aortic dissection who underwent arch-clamping technique at our institution between January 2020 and December 2024. Among them, there were 241 males (78.5%) and 66 females (21.5%); the median age was 52 years [interquartile range (IQR): 44–57 years]. Inclusion criteria: (I) diagnosis of DeBakey type I aortic dissection confirmed by echocardiography or aortic computed tomography angiography (CTA) according to the 2010 American Heart Association/American College of Cardiology (AHA/ACC) Thoracic Aortic Disease Guidelines; (II) time from onset to surgical treatment ≤14 days; (III) patients or their family members voluntarily signed the informed consent form. Exclusion criteria: (I) pregnant women; (II) patients already intubated or in a comatose state preoperatively; (III) patients with connective tissue diseases such as Marfan syndrome. Patients were divided into two groups based on the lowest rectal temperature during circulatory arrest: mild hypothermia group (n=122), circulatory arrest temperature 28.1–34 ℃; moderate hypothermia group (n=185), circulatory arrest temperature 20.1–28 ℃. Group allocation was determined by surgeon preference and evolved over time; from 2020 to 2021 moderate hypothermia was routine, while from 2022 onward mild hypothermia became the preferred approach. This study complied with the principles of the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of The First Affiliated Hospital of Guangxi Medical University (approval No. 2025GXNSFAA069056, approved on March 15, 2025) and informed consent was taken from all individual participants.

Study endpoints

Primary endpoint event

Composite adverse outcome, including 30-day mortality, stroke, paraplegia, and the need for continuous renal replacement therapy (CRRT). Stroke was defined as radiologically confirmed cerebral infarction accompanied by clinical symptoms such as hemiplegia or coma; postoperative neurological assessment included clinical examination by a neurologist; temporary neurological dysfunction (TND) was defined as postoperative confusion, agitation, delirium, or transient Parkinsonism with negative brain imaging. Postoperative acute kidney injury (AKI) was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) classification criteria (11); hepatic dysfunction was defined as postoperative transaminase levels >1.5 times the upper limit of normal (12).

Secondary endpoint events

Cardiopulmonary bypass (CPB) time, aortic cross-clamp time, mechanical ventilation >24 hours, intensive care unit (ICU) length of stay, and hospital length of stay. Malperfusion was diagnosed based on aortic CTA indicating involvement of visceral branch arteries, accompanied by abnormal relevant organ function laboratory tests or clinical manifestations (2).

Surgical technique (Figures 1,2)

Figure 1 Operation process. (A) CPB was instituted through the right axillary and femoral artery. (B) The stent graft was deployed into true lumen of the descending aorta. (C) The stent and the aorta were clamped together, lower body was perfused through femoral lines. Anastomosed 4-branched prosthetic graft to the FET collar. (D) After the left common carotid artery anastomosis was finished, rewarming was initiated. (E) Ascending aorta was sutured to 4-branched graft. (F) Left subclavian and innominate arteries were subsequently reconstructed. All arrows consistently indicate blood flow direction throughout the operative procedure. CPB, cardiopulmonary bypass; FET, frozen elephant trunk.

Figure 2 Surgical techniques. (A). Lower body circulatory arrest start, stented graft was inserted into the true lumen of the descending aorta. (B) The stent-free sewing edge was pulled out from the proximal end of the stent. (C) The distal ascending aorta containing the intraluminal stent graft was clamped, then femoral arterial line was de-clamped, and cerebral and lower body perfusion were provided through right axillary and femoral lines respectively, the circulatory arrest was maintained for approximately 4 minutes. The CPB flow was gradually returned to full rate. (D) Anastomosis of the proximal descending aorta containing the intraluminal stent graft to the 4-branched graft. (E) After the descending aorta was anastomosed to the graft, the arch-clamp was removed. And proximal end of the tetrafurcate was clamped. (F) Systemic re-warming was started as soon as the left common carotid artery anastomosis was completed. (G) After finishing the proximal aortic anastomosis, the clamp was removed in order to reduce cardiac ischemia time. The left subclavian artery and innominate artery anastomoses were then performed in order. CPB, cardiopulmonary bypass.

Arterial cannulation and aortic root procedures

Using conventional median sternotomy, the arterial blood pressure of both the left upper and lower limbs was monitored. The right axillary artery and the femoral artery were cannulated for CPB, and the right axillary artery was used for selective antegrade cerebral perfusion (SACP) (Figure 1A). During the cooling phase, proximal manipulations such as coronary artery bypass grafting (CABG), sinus of Valsalva reconstruction, aortic valve repair, the David, Cabrol or Bentall procedure were performed accordingly.

HCA

Circulatory arrest was instituted when the nasopharyngeal temperature reached 28 ℃. Meanwhile, SACP was started at a rate of approximately 5–10 mL/kg per min, the monitoring pressure was maintained at 40–60 mmHg (1 mmHg =0.133 kPa). The aortic arch was transected between the left common carotid and left subclavian arteries to avoid recurrent laryngeal nerve injury.

Stented graft release

A compressed stent graft (Figure 3) (MicroPort Medical Co., Ltd., Shanghai, China, diameter: 23–28 mm, length: 120 or 150 mm) was inserted into the true lumen of the aortic arch and descending aorta and deployed (Figure 1B).

Figure 3 New stent artificial graft Cronus^® of Shanghai Microport company.

Application of aortic arch clamp

During circulatory arrest, the stented graft free sewing edge was carefully pulled out from the proximal end of the stent, the aorta containing the intraluminal stented graft was clamped together between the left common carotid artery and left subclavian artery at the aortic Z2 position. In cases where Zone 2 is anatomically short (<1.5 cm), we either perform the anastomosis at Zone 1 (between innominate artery and left common carotid) or use a partial clamp technique to avoid excessive tension.

Reperfusion of the lower body

Once the distal ascending aorta containing the intraluminal stented graft were clamped together, perfusion of the lower body through the femoral artery was immediately resumed and the time of circulatory arrest was reduced to approximately 4 minutes. Circulation was then resumed, the CPB flow was gradually returned to full rate (Figure 1C). Notably, it was ensured that the soft edge was completely clamped and that no blood leaked out, which conveniently allowed the surgeon to have a clear view during anastomosis.

Distal arch anastomosis and the removal of the clamp

After the descending aorta was anastomosed to the 4-branched graft, the atraumatic aortic clamps were withdrawn and the graft and its branches were clamped. The left common carotid artery was anastomosed first, after which both carotid arteries could be perfused when rewarming for the patient was started (Figure 1D).

Epiaortic vessel reconstruction and proximal arch anastomosis

The ascending aorta was sutured to the proximal 4-branched graft and the heart started beating (Figure 1E). Then anastomosed the left subclavian artery and innominate artery were then performed sequentially (Figure 1F). The operative technique is illustrated in Figure 2.

Near-infrared spectroscopy (NIRS, model YN-9002, ENO, Anhui, China) was used to monitor bilateral cerebral oxygen saturation intraoperatively. Left radial artery pressure was monitored continuously. If cerebral oxygen saturation decreased by >20% from baseline or the bilateral difference exceeded 5%, bilateral cerebral perfusion was initiated, maintaining left radial artery pressure >25 mmHg.

Follow-up methods

Patients underwent preoperative and postoperative echocardiography and aortic CTA prior to discharge. Routine follow-up aortic CTA was performed at 6 months, 12 months postoperatively, and annually thereafter. Long-term survival and reintervention data were recorded through outpatient clinic visits, telephone calls, or WeChat communication. The follow-up period ended in December 2025.

Statistical analysis

Data analysis was performed using R software version 4.3.0. Graphs were generated using GraphPad Prism version 9.5.1. Continuous variables are presented as median (IQR) and were compared between groups using the Mann-Whitney U test, with the U statistic reported. Categorical variables are presented as n (%) and were compared using the Chi-squared test or Fisher’s exact test (when expected cell count <5). Multivariate logistic regression analysis was performed using forced entry of clinically important variables (including age, lactate, CPB time, aortic cross-clamp time, circulatory arrest temperature group, transfusion volumes, and malperfusion sites) to identify independent risk factors for adverse outcomes. Model adequacy was assessed using the Hosmer-Lemeshow goodness-of-fit test. Cumulative survival rates were calculated using the Kaplan-Meier method, and differences between groups were compared using the log-rank test; hazard ratios (HR) with 95% confidence intervals (CI) were obtained from Cox regression. A P value <0.05 was considered statistically significant.

Results

Comparison of baseline characteristics

The two groups were well-balanced regarding age, body mass index (BMI), left ventricular end-diastolic diameter, hemoglobin, platelet count, liver and kidney function parameters, and the distribution of comorbidities (hypertension, diabetes, coronary artery disease, etc.), with no statistically significant differences (all P>0.05). The preoperative left ventricular ejection fraction (LVEF) in the mild hypothermia group was 63.5% (IQR: 60.5%, 66.2%), slightly higher than the 61.2% (IQR: 59.8%, 63.5%) in the moderate hypothermia group (P=0.01), although both values were within the normal range and not clinically significant. Regarding malperfusion syndromes, lower limb malperfusion was the most common (11.8%), followed by cerebral malperfusion (8.8%). There were no statistically significant differences in the incidence of malperfusion at various sites between the two groups (all P>0.05) (Table 1).

Comparison of intraoperative data

There was no significant difference in the circulatory arrest time between the two groups [3.00 (IQR: 3.00, 4.00) vs. 3.00 (IQR: 3.00, 4.00) min, P=0.38]. The intraoperative lowest rectal temperature was 28.6 ℃ (IQR: 28.3, 29.2 ℃) in the mild hypothermia group and 25.7 ℃ (IQR: 24.7, 26.5 ℃) in the moderate hypothermia group, a statistically significant difference (P<0.001). The mild hypothermia group had significantly higher rates of concomitant CABG (15.6% vs. 5.4%, P=0.009) and femoral artery bypass grafting (16.4% vs. 5.9%, P=0.004) compared with the moderate hypothermia group. To account for potential confounding by concomitant procedures, we performed a subgroup analysis excluding patients who underwent CABG or femoral artery bypass grafting (n=48 in mild group, n=164 in moderate group). In this subset, CPB time (142.3±28.7 vs. 158.9±32.1 min, P=0.03) and aortic cross-clamp time (85.1±21.4 vs. 96.7±24.8 min, P=0.04) remained significantly shorter in the mild hypothermia group. There were no significant differences in the volume of blood product transfusions between the two groups (all P>0.05) (Table 2).

Comparison of early postoperative outcomes

The overall incidence of the composite adverse outcome among the 307 patients was 18.9%. The 30-day mortality was 7.5%, stroke rate 6.2%, spinal cord injury rate 4.9%, and CRRT rate 11.7%. The incidence of the composite adverse outcome was lower in the mild hypothermia group (12.3%) compared to the moderate hypothermia group (23.2%), but the difference was not statistically significant (P=0.058). There were no statistically significant differences in the incidence of major adverse events, including 30-day mortality, stroke, spinal cord injury, and CRRT, between the two groups (all P>0.05). The incidence of TND was 4.9% in the mild group and 6.5% in the moderate group (P=0.58). No patient underwent routine brain magnetic resonance imaging (MRI); therefore, silent cerebral infarcts could not be assessed. Postoperative recurrent laryngeal nerve palsy occurred in 4 patients (3.3%) in the mild group and 7 patients (3.8%) in the moderate group (P=0.81). All cases were transient and resolved within 6 months. There were no cases of tracheostomy or reintubation in the mild hypothermia group. The duration of mechanical ventilation, ICU length of stay, and hospital length of stay were slightly shorter in the mild hypothermia group, but the differences were not statistically significant (all P>0.05). There were also no significant differences in the incidence of complications such as AKI (by KDIGO stage), hepatic dysfunction, and gastrointestinal bleeding between the two groups (all P>0.05) (Table 3).

Multivariate logistic regression analysis

Multivariate logistic regression with forced entry of clinically relevant variables showed that age [odds ratio (OR) =1.18, 95% CI: 1.03–1.35, P=0.02] and lactate (OR =1.82, 95% CI: 1.05–3.16, P=0.03) were independent risk factors for 30-day mortality. For 30-day mortality (23 events), the model included 6 variables (age, lactate, CPB time, cross-clamp time, temperature group, and preoperative malperfusion), yielding an events-per-variable ratio of 3.8. The Hosmer-Lemeshow test showed good calibration (χ²=5.23, P=0.73). Lactate (OR =2.12, 95% CI: 1.15–3.89, P=0.02), volume of fresh frozen plasma transfusion (OR =1.01, 95% CI: 1.00–1.01, P=0.04), and volume of platelet transfusion (OR =1.56, 95% CI: 1.02–2.38, P=0.04) were independent risk factors for postoperative hepatic dysfunction. CPB time (OR =1.03, 95% CI: 1.01–1.06, P=0.02), volume of packed red blood cell transfusion (OR =1.18, 95% CI: 1.00–1.39, P=0.045), and volume of platelet transfusion (OR =2.03, 95% CI: 1.00–4.12, P=0.049) were associated with the need for CRRT. Volume of packed red blood cell transfusion was an independent risk factor for gastrointestinal bleeding (OR =1.11, 95% CI: 1.02–1.21, P=0.01) and prolonged mechanical ventilation >48 hours (OR =1.13, 95% CI: 1.01–1.26, P=0.03). Mesenteric malperfusion (OR =14.52, 95% CI: 1.23–171.85, P=0.03) was also an independent risk factor for mechanical ventilation >48 hours. Circulatory arrest temperature group (mild vs. moderate) was not an independent predictor of 30-day mortality (OR =0.78, 95% CI: 0.45–1.35, P=0.37), CRRT, or other adverse outcomes in the forced-entry models (Table 4).

Comparison of long-term outcomes

The median follow-up time was 2.5±1.3 years, with a follow-up completion rate of 100%. There were 8 long-term deaths, all in the moderate hypothermia group: 5 died from pulmonary infection, 2 from cardiocerebrovascular events, and 1 from sudden death of unknown cause. There were 15 cases requiring reoperation: 10 cases (8.2%) in the mild hypothermia group [6 underwent second-stage thoracoabdominal aortic replacement, 4 underwent thoracic endovascular aortic repair (TEVAR)] and 5 cases (5.9%) in the moderate hypothermia group (all underwent second-stage thoracoabdominal aortic replacement). On follow-up CTA, no patient in either group developed significant stenosis (>50% diameter reduction) at the site of fabric clamping. No reinterventions were required for fabric-related stenosis. Kaplan-Meier survival analysis showed that the long-term survival rate was 92.6% in the mild hypothermia group and 88.7% in the moderate hypothermia group (Log-rank χ² =0.07, P=0.78). Cox regression analysis showed a HR of 0.52 (95% CI: 0.21–1.28, P=0.15) for long-term mortality in the mild vs. moderate group, and 1.41 (95% CI: 0.48–4.12, P=0.53) for reintervention. There was no statistically significant difference in the long-term reintervention rate between the two groups (Log-rank χ² =2.17, P=0.15). The survival curve is shown in Figure 4, and the cumulative incidence of reoperation is shown in Figure 5.

Figure 4 Follow-up survival rate of patients in the mild hypothermia group and the moderate hypothermia group.

Figure 5 Follow-up cumulative reoperation rate of patients in the mild hypothermia group and the moderate hypothermia group.

Discussion

DeBakey type I aortic dissection involves an extensive lesion area and presents a critical condition. The core of surgical treatment lies in the thorough repair of the lesion and the protection of vital organ function (13,14). The traditional Sun’s procedure relies on HCA, and the choice of circulatory arrest temperature remains a focus of clinical debate (15). Although deep HCA can suppress organ metabolism, prolonging the arrest time significantly increases the risk of neurological complications and multi-organ injury (16). Moderate HCA combined with SCP has gradually replaced deep HCA, but it still presents issues such as a complex surgical procedure and relatively long CPB times (17,18). The arch-clamping technique developed by our team in preliminary work reduced the circulatory arrest time to approximately 3 minutes, laying the foundation for further raising the arrest temperature and optimizing the surgical strategy (6,7).

This expanded study with 307 cases found that compared to the moderate hypothermia technique, the mild hypothermic arch-clamping technique (circulatory arrest temperature 28.1–34 ℃) showed no significant difference in the incidence of major adverse outcome events. However, the incidence of the composite adverse outcome was lower in the mild hypothermia group (12.3%) than in the moderate hypothermia group (23.2%), showing a trend towards improved outcomes. More importantly, both CPB time (145.2 vs. 161.8 min) and aortic cross-clamp time (87.6 vs. 98.3 min) were significantly shorter in the mild hypothermia group, consistent with the findings of our earlier smaller-sample study (8). The shorter aortic cross-clamp time in the mild hypothermia group may reflect the streamlined surgical process without prolonged cooling and rewarming, as well as potential differences in case complexity despite adjustment for concomitant procedures. However, unmeasured confounders could contribute to this difference. Shortening these key surgical times can reduce the adverse effects of prolonged CPB on the body, lower the risk of ischemia-reperfusion injury, simplify the surgical procedure, and improve surgical efficiency, which is particularly important for emergency surgery.

Optimization of the circulatory arrest temperature is the core innovation of this study. Research by Strauch et al. indicated that when body temperature drops to 28 ℃, cerebral oxygen consumption is reduced to 50% of baseline, and further cooling does not significantly reduce cerebral oxygen consumption (18). Additional evidence supports the safety of mild HCA when arrest time is brief (9,10,19-21). In this study, the lowest rectal temperature in the mild hypothermia group was 28.6 ℃. Combined with the very short (approximately 3 minutes) circulatory arrest time enabled by the arch-clamping technique, this was sufficient to ensure the safety of cerebral tissue and other vital organs. In the forced-entry multivariate regression analysis, circulatory arrest temperature group was not a significant predictor of adverse outcomes, further supporting the safety of the mild hypothermia strategy. This is consistent with the findings of Zierer et al. (9), who, through 15 years of clinical practice, confirmed that moderate-to-mild hypothermic techniques for ATAAD surgery can achieve good outcomes.

The choice of arterial cannulation strategy is crucial for surgical safety. This study employed a combined axillary and femoral artery cannulation approach. This ensured effective unilateral antegrade cerebral perfusion (ACP) while allowing rapid restoration of distal organ perfusion via the femoral artery cannula. The overall postoperative stroke rate was 6.19%, comparable to the 6–10.5% reported in similar domestic and international studies (22-24). This cannulation strategy may reduce the risk of cerebral embolization while avoiding the limitations on the surgical field posed by a single cannulation site, serving as an important safeguard for the successful implementation of the arch-clamping technique.

Furthermore, this study found that blood product transfusions were associated with several adverse outcomes. For example, volumes of fresh frozen plasma and platelet transfusions were risk factors for hepatic dysfunction, and the volume of packed red blood cell transfusion was associated with gastrointestinal bleeding and prolonged mechanical ventilation. Hypothermia can affect coagulation function, increasing perioperative bleeding and the need for blood product transfusions (25,26). The mild hypothermia technique may reduce the inhibition of coagulation function caused by deeper hypothermia, potentially decreasing transfusion requirements, which could be one of the underlying mechanisms for its improved outcome trend. The association between blood product transfusions and adverse outcomes should be interpreted cautiously, as transfusion requirements may be a marker of intraoperative bleeding severity or complexity rather than a direct causal factor. Despite adjusting for CPB time and concomitant procedures, residual confounding may remain.

The strengths of this study lie in its relatively large sample size (307 cases) and prospectively collected data, which ensured completeness and reliability. The 100% follow-up completion rate provides strong support for the conclusions. However, there are certain limitations: it is a single-center study, potentially introducing selection bias; the non-randomized, time-dependent allocation may introduce selection bias, and the two groups had different proportions of concomitant procedures, although subgroup analysis suggested the benefits of mild hypothermia persist. Due to the limited number of events, our multivariate models may be susceptible to overfitting despite the use of forced entry and adequate Hosmer-Lemeshow tests; therefore, results should be interpreted cautiously. Although the mild hypothermia group predominantly represents a later surgical era, sensitivity analysis adjusting for year of surgery showed no significant confounding effect on outcomes. Future multicenter randomized controlled trials are needed to further validate these findings.

Conclusions

In summary, mild hypothermic arch-clamping for DeBakey type I aortic dissection offers technical advantages by shortening operative times and simplifying the procedure, with a trend toward better composite outcomes, though not statistically significant. It appears safe and provides satisfactory short- and long-term results.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE and SUPER reporting checklists. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2026-1-0189/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2026-1-0189/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2026-1-0189/prf

Funding: This study was supported by The Natural Science Foundation of Guangxi (grant No. 2025GXNSFAA069056); The National Natural Science Foundation of China (grant No. 82360066); The Guangxi Key Research and Development Program Project (grant No. AB24010153); and The Guangxi Medical and Health Appropriate Technology Development and Promotion Project (grant No. S2022066).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2026-1-0189/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study complied with the principles of the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of The First Affiliated Hospital of Guangxi Medical University (approval No. 2025GXNSFAA069056, approved on March 15, 2025) and informed consent was taken from all individual participants.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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