Aortic remodeling after zone 0 simplified delivery frozen elephant trunk (SD-FET) technique in acute aortic dissection: one-year clinical and morphological results in a single centre

Introduction

The incidence of acute aortic dissection (AAD) varies widely in the literature, from 3 to 16 individuals per 100,000 per year, and is probably underestimated as many people die from unknown cause before reaching a hospital (1). Prompt diagnosis and treatment are crucial, particularly for type A AAD (2), for which current guidelines recommend urgent surgery (3). Among the available surgical options, the frozen elephant trunk (FET) procedure, first described in 1996 (4), has become increasingly common as it promotes aortic remodeling and facilitates subsequent endovascular repair of the remaining dissected aorta (5,6). Indeed, improvements in surgical techniques and perioperative care have led to increased survival, which in turn presents long-term challenges (7,8). Positive aortic remodeling of the downstream dissected aorta and promoting false lumen (FL) thrombosis are of paramount importance to reduce aortic related reinterventions and improve survival.

The conventional FET surgical technique includes a distal anastomosis in distal zone 3 and in the zone 2 when feasible (according to the Ishimaru classification) and delivery of the stent-graft, under hypothermic circulatory arrest. To reduce the technical difficulties and simplify the procedure, several centers have adopted a more proximal stent-graft insertion in zone 0 (9,10). This eliminates the need for deep resection of the aortic arch and simplifies the distal anastomosis. In our quest for surgical simplicity, we introduced the simplified delivery frozen elephant trunk (SD-FET) technique in 2021, which is characterized by proximalization in zone 0 and a very short circulatory arrest of the lower body that allows normothermia, thanks to 2 tourniquets around the aortic arch (11). This strategy reduces the duration of circulatory arrest (4.5±2.8 min), mortality and paraplegia (no in-hospital death and no spinal cord injury reported in the first fifteen cases) (11).

However, few studies have examined the effects of FET proximalization on the remaining dissected aorta and long-term aortic remodeling. In a limited number of patients, proximal deployment in zone 0 has been reported to provide similar long-term aortic remodeling as traditional deployment in zone 2, but further studies are needed to confirm these results and to highlights its survival benefits (10).

The aim of this study was to evaluate the early, 3-month, 6-month and 1-year outcomes of the SD-FET technique in AAD in terms of complications, aortic remodeling and aortic reinterventions. We present this article in accordance with the STROBE reporting checklist (available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-aw-600/rc).

Methods

Ethics

This retrospective single-centre study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. It is not classified as research requiring formal ethical approval under French law or European guidelines (definitions at www.emea.europa.eu). The clinical data were recorded in an anonymized database and patients gave their written consent for their data to be recorded.

Design

We retrospectively analysed data from a prospectively maintained database of all patients admitted to Department of Cardiac and Vascular Surgery, L’Institut du Thorax for AAD. Medical records and computed tomography angiography (CTA) images at the time of the index procedure, after 3, 6 and 12 months were retrospectively analysed. Most of the surgeons in our team have been using SD-FET for AAD since September 2018. To reduce the risk of distal stent-graft-induced new entry (dSINE), the SD-FET technique was not used in patients with a reduced aortic descending aortic diameter (<25 mm), a severe isthmic angulation, or when significant mismatch with the true lumen (TL) was anticipated in the absence of a validated quantitative definition (oversizing of the lowest size of the stent-graft >10% as compare to the TL diameter). In these cases, the surgical technique was left to the discretion of the surgeon.

Patients

All patients who have undergone aortic arch repair with the SD-FET technique for AAD between September 2018 and January 2023 at the University Hospital of Nantes, France were included. Perioperative information such as age, gender, comorbidities, clinical presentation on admission, intraoperative details, postoperative complications and death, preoperative and postoperative CTA were reviewed for each patient. For each patient, EuroSCORE II was calculated. In addition to EuroSCORE II, the GERAADA score was calculated to provide a more accurate estimation of operative mortality risk in acute type A aortic dissection. After discharge, patients were followed up in the hospital with CTA at 3, 6 and 12 months (and annually thereafter). Clinical and morphologic data on aortic remodeling, aortic related-complications and reinterventions were analyzed retrospectively, however, analyses were performed using available imaging data at each time point, as not all patients completed every scheduled examination. In-hospital mortality was defined as death before discharge. Major complications, including stroke and spinal cord ischemia, as well as early and late reinterventions and both all-cause and aortic-related mortality were recorded.

Surgical technique of SD-FET

The SD-FET surgical technique has been described previously (11,12), and primarily involves placing two surgical sealing tourniquets with a blunt dissector around the aortic arch, typically between the innominate artery and the left common carotid artery. The two sealing tourniquets are gradually tightened on the aortic arch facing the stent until a zone 0 or 1 seal is achieved. The choice between zone 0 and zone 1 implantation was a purely intraoperative decision left to the surgeon’s discretion and was primarily guided by the length and configuration of the ascending aorta, with shorter ascending aortas favoring zone 1 implantation and longer, well-developed ascending aortas allowing safe proximalization to zone 0. Tourniquets should be tightened gently under the pressure of the antegrade arterial blood flow of the cardiopulmonary bypass (CPB). Complete apposition of the stent to the aortic wall in the tourniquets area allows for a nearly complete seal. The distal anastomosis could then be performed on a loaded aorta. In normothermic procedures, cerebral protection was systematically ensured through selective bilateral antegrade cerebral perfusion via a dual access to the right and left subclavian arteries prior sternotomy. At the end of the procedure, the 8 mm Dacron graft sutured to the left subclavian artery (LSA) can be reimplanted onto the main graft via an extra-anatomical passage. Regarding stent sizing in AAD, a true size would be taken (assuming the descending aorta is not dilated) to avoid the risk of implanting a larger stent than necessary in acutely dissected tissue, which carries a risk of rupture. During the early phase of our experience, LSA revascularization was not systematically performed in critically unstable patients; however, the strategy evolved over time toward systematic bilateral axillary artery exposure with extra-anatomical LSA reimplantation to standardize the procedure and improve reproducibility.

Follow-up and reinterventions of the remaining dissected aorta

All patients underwent preoperative (except one), postoperative (within 15 days) CTA (Figure 1A,1B). After discharge, patients were followed by clinical examination and CTA at 3 months, 6 months, 12 months and annually thereafter. Indications for re-intervention were dSINE (distal stent-graft induced new entry), distal FL negative remodeling of more than 5 mm in 6 months or reaching the aortic diameter threshold of ≥5.5 cm (13), type IB endoleak with retrograde arch enlargement, distal malperfusion or complications in the LSA (if not reimplanted during the index procedure or not ligated after extra-anatomical bypass).

Figure 1 Pre- and postoperative CTA imaging and measurement landmarks. (A) Preoperative axial CTA showing acute type A aortic dissection involving the ascending aorta and arch. (B) Three-dimensional reconstruction of the thoracic aorta before surgery. (C) Sagittal postoperative CTA reconstruction illustrating the predefined measurement levels used for morphometric analysis. The celiac trunk was used as a fixed anatomical landmark, with measurements obtained 20 and 10 cm above the celiac trunk to assess the proximal and distal descending thoracic aorta, respectively. CTA, computed tomography angiography.

Morphological analysis

Measurements on CTAs were performed using TeraRecon Aquarius software version 4.4.12 (San Mateo, California, USA). Aortic remodeling assessment was based exclusively on dimensional analysis, and no volumetric analysis was performed. We divided the aorta into four segments: the proximal thoracic descending aorta (20 cm above the coeliac trunk), the distal thoracic descending aorta (10 cm above the coeliac trunk), the aorta at the level of the coeliac trunk, and the infrarenal aorta (Figure 1C). Measurements of the total aortic diameter, TL diameter, and FL diameter were performed at the widest portion of each segment using a centerline technique.

We classified aortic remodeling into three groups based on a previous report by Dohle et al. (6): positive, stable, and negative remodeling. A threshold value of 10% was used to define a significant change. Positive remodeling was defined as either a 10% increase in TL diameter with a stable total aortic diameter or a 10% decrease in total aortic diameter with stable TL. Changes within 10% were considered stable remodeling. Other changes were defined as negative remodeling (either increase >10% of the total aortic diameter without significant decrease of the TL or increase of the TL >10% with simultaneous increase >10% of the total aortic diameter). Figure S1 shows preoperative, eraly and late postoperative 3D morphological evolution.

Clinical end-points

The primary endpoint was the aortic remodeling status (positive, stable, or negative) of the remaining proximal dissected aorta at 12 months after the index procedure, with particular attention to the occurrence of negative remodeling. Secondary endpoints included aortic remodeling status at 3 and 6 months at predefined aortic levels, early and late aortic-related complications and reinterventions, and aortic-related mortality at 12 months.

Statistical analysis

Data were analyzed with descriptive statistics. All values were expressed as counts and percentages or mean ± standard deviation (median for time to follow-up). Time-to-event analysis with Kaplan-Meier curves were used to estimate overall survival and survival without reintervention at 12 months. Survival rate estimation was presented with confidence interval at 95% (95% CI). Mixed models were used to analyze the volumetric aortic changes in each segment. SAS version 9.4 software was used to perform analyses. A P value <0.05 was considered statistically significant.

Results

Patient characteristics

Between September 2018 and January 2023, 30 consecutive patients (73% men, mean age 69±9 years) with AAD underwent a total arch repair using the SD-FET technique at Nantes University Hospital, France. During the same period, 103 additional patients underwent type A AAD repair using an alternative technique and were excluded from this study. The Thoraflex^TM hybrid prosthesis (Terumo Aortic, Inchinnan, Scotland, UK) was used in all patients. Among the implanted devices, two stent grafts had a length of 150 mm, whereas 28 devices had a length of 100 mm. Details of patient’s preoperative characteristics are provided in Table 1: 17 (57%) patients presented chronic arterial hypertension, 1 (3.3%) had connective tissue disorder and 1 (3.3%) had a history of cardiac surgery. The EuroSCORE II score was 3.79±1.91, including 3 (10%) patients in a critical state. The mean predicted operative mortality according to the GERAADA score was 21.78 (SD 7.18).

Intra-operative characteristics

All patients underwent total arch and ascending aorta replacement in zone 0 with SD-FET technique, including 4 (13.3%) patients with additional aortic root replacement (3 Bentall and 1 David procedures). Mean CA was 6±2 minutes at a body temperature of 34±1 ℃; lactic acid peak was 4±2 mmol/L (see Table 2 for details).

In 16 (53.3%) patients, the LSA was revascularized through an extra-anatomical bypass during the index procedure; 8 (26.7%) had postoperative LSA transposition in the left common carotid. Among the 6 patients without initial LSA revascularization, one patient developed acute upper extremity ischemia requiring urgent left carotid-subclavian bypass performed 24 hours after the index surgery. No other LSA-related complications were observed.

In-hospital outcomes

The in-hospital mortality rate was 13.3% (4 deaths, 2 were due to stroke and 2 were attributed to multiple organ failure), no patient died during the procedure. The spinal cord ischemia rate was 0% and the stroke rate was 13.3% (4 major strokes including 2 leading to death). Early reintervention [thoracic endovascular aortic repair (TEVAR)] was required in three patients due to a rapid increase in the downstream aorta and renal malperfusion. Analysis excluding the three patients who received TEVAR immediately after SD-FET demonstrated no meaningful modification of postoperative outcome measures (data not shown). These patients were therefore maintained in the main dataset to reflect real-world management of extensive aortic dissection. All data are shown in Table 3.

1-year outcomes

The median follow-up time was 15 [10–23] months. One patient died during follow-up on day 104 from aortic-related death following a spontaneous celiac trunk rupture. The overall survival rate was 83% (95% CI: 71–98%) at 1 year (Figure 2A). Major complications rate was 13% (4 patients), including 1 transient ischemic attack and 3 cardiovascular events (1 endocarditis and 2 prosthesis-related infections both with mild clinical presentation). Given the high risk associated with surgical reintervention, both cases were managed conservatively with prolonged antibiotic therapy. Follow-up 18F-fluorodeoxyglucose positron emission tomography-computed tomography (¹⁸F-FDG PET-CT) at the end of treatment showed favorable evolution, with no evidence of persistent infection). One patient required aortic reintervention for a penetrating aortic ulcer located in the thoracic descending aorta, which was managed with TEVAR on day 131 and one patient required an attempt aortic reintervention for a spontaneous celiac trunk rupture. Overall freedom from aortic reintervention was 92.5% (95% CI: 83–100%) at 1-year (Figure 2B).

Figure 2 Clinical outcomes and aortic remodeling during follow-up. (A) Kaplan-Meier curve for overall survival. (B) Kaplan-Meier curve for freedom from distal aortic reintervention. (C) Evolution of true and false lumen diameters at the proximal descending thoracic aorta, distal descending thoracic aorta, coeliac trunk level, and infra-renal aorta from preoperative assessment to 12-month follow-up. (D) Distribution of aortic remodeling patterns (positive, stable, negative) at 12 months according to predefined criteria. CI, confidence interval; KM, Kaplan-Meier; TL, true lumen.

Aortic morphometric changes

Figure 2C shows the volumetric aortic changes regarding each aortic segment. In the proximal descending aorta, decrease of FL (FL preoperative 14.1±1.5; FL M12 6.9±1.7; P<0.001 , in mm) and increase of the TL (TL preoperative 22.5±1.1; FL M12 28.4±1.3; P<0.001, in mm) were consistent across time. Distal descending aorta and aorta at the coeliac trunk level showed the same pattern evolution with an initial decrease of the FL and an increase of TL, but a subsequent change after 3 months with an increase of FL and decrease of TL. Stability at the infra-renal level was observed.

Details are provided in Table 4.

Aortic remodeling and FL thrombosis

Results of the remodeling process are presented in Figure 2D. In the proximal, distal descending thoracic aorta, coeliac and infra-renal aorta, positive or stable remodeling was observed in 79%, 53%, 63% and 63% of patients, while negative remodeling was observed in 21%, 47%, 37% and 37% respectively.

The rate of FL occlusion reached 60% at 6 months and up to 80% at 1 year. Downstream segments showed lower rates of thrombosis (40%) over time.

Discussion

In our study, we observed an increase in the TL and decrease in the FL resulting in a positive aortic remodeling at the proximal thoracic descending aorta at 1 year. The distal thoracic descending aorta and the celiac aorta shows less positive aortic remodeling across time. Clinical outcomes at 1 year shows 92% free from aortic reintervention and one aortic related death.

The FET technique is now a well-established and effective therapeutic option for the treatment of chronic atheromatous aneurysms of the arch (14). Nevertheless, the technique remains controversial in AAD due to the associated technical challenges, even though the morbidity and mortality reported in the literature seems comparable to conventional surgery (15,16). In this study of 30 consecutive patients treated with the SD-FET procedure for AAD, we report early outcomes comparable to those published for conventional FET, including an in-hospital mortality rate of 13%. In this study of 30 consecutive patients treated with SD-FET procedure during AAD, we report comparable results in the acute phase (13% in-hospital mortality, 13% of stroke and 13% of reoperation for bleeding) compared to publications on the conventional FET procedure (up to 21% of mortality, 17% stroke and 18% renal failure) (17-21). The use of a normothermic strategy was primarily intended to simplify the procedure and reduce CPB time (12). In cases of primary distal malperfusion, this technique also provides a rapid method to restore flow into the TL, given the very short circulatory arrest and the performance of the anastomosis under CPB. Although the mean EuroSCORE II was relatively low in this cohort, this score is not calibrated for emergency aortic surgery and does not adequately reflect the operative risk associated with acute type A dissection. In our cohort, the mean predicted operative mortality according to the GERAADA score was 21.78%, reflecting the high-risk profile of patients presenting with acute type A aortic dissection. This contrasts with the relatively low mean EuroSCORE II and supports the notion that disease-specific risk models more accurately capture operative risk in this setting. Notably, the observed in-hospital mortality of 13% was lower than the mortality predicted by the GERAADA score, suggesting that the SD-FET strategy may provide acceptable early outcomes despite the severity of the underlying condition.

The length of aortic coverage is one of the most important factors associated with spinal cord injury, especially in a context of post-operative hemodynamic instability (22). FET inherently increases the length of aortic coverage compared to conventional ascending or arch replacement. A rate of 8% of spinal cord injury after FET conventional technique in AAD has been reported (23). None of the patients in our cohort had a spinal cord injury. Causes for spinal cord injury seems to be multifactorial, including the influence of the stent graft length, the degree of hypothermia and the duration of circulatory arrest. The SD-FET technique solves two of the criteria: it is performed in normothermia and it allows a shorter duration of circulatory arrest. This may be the reason why we observed such a low rate of spinal cord injury (23-26).

During follow-up, we observed one aortic-related death at 1 year (and no other death) and two aortic reinterventions during follow-up. When compared these results to current conventional FET-associated outcomes, mid-term mortality rate is similar (92% of survival at 1 year in the survivors from index procedure versus 92% in literature) as was the rate of freedom from aortic reintervention at 1 year (92.5% in our group versus 87%) (18).

One of the key factors involved in mid-term and long-term outcomes is FL patency (27). As secondary entry tears, FL patency—and even more partially thrombosed FL with higher pressure level—acts as a trigger to FL growth in the remaining dissected aorta, leading to secondary reintervention (28-30). One of the strengths of the FET procedure is to promote FL thrombosis and thereby reduce secondary procedure (31).

In this way, aortic remodeling can be considered as one of the predictors of future reinterventions. Conventional FET is associated with high degree of positive or stable aortic remodeling in the proximal segment of the remaining aorta (90% at 1 year), compared to conventional arch replacement (significant increase at the 8^th thoracic vertebra and coeliac trunk level, respectively 0.23 and 0.55 mm/year growth rate) (32), and as a consequence a decrease of the total aortic diameter. This can be explained by the potential of the FET to occlude and seal entry tears located at the stent-graft level, in contrast of conventional arch replacement (32-34).

Our results in the proximal descending aorta are consistent with 79% of positive/stable aortic remodeling at 1 year. These results are confirmed with a significant decrease of the FL diameter and increase of the TL diameter at 3 months, 6 months and 1 year.

Yet, these results are not consistent once we get closer to the coeliac trunk with 53% of positive/stable aortic remodeling at the distal thoracic descending aorta and 63% at the coeliac trunk level. Although a longer distal stent-graft or secondary TEVAR could theoretically promote additional FL thrombosis, this must be balanced against the increased risk of spinal cord ischemia associated with extended aortic coverage. For this reason, we favor a conservative distal extent of the SD-FET and perform secondary TEVAR only when clinically indicated. Current literature on conventional FET and the first results of FET proximalization without the SD-FET technique are similar (up to 80% of positive remodeling at 1 year of the proximal descending aorta and 80% of stable/positive remodeling at the coeliac trunk level when proximalization is performed) (9,10,35,36). Thus, our results confirms that the thoraco-abdominal junction remain the main source of concern regarding the aortic remodeling with higher rates of FL patency and negative aortic remodeling (8,37,38).

These findings suggest that the SD-FET procedure may be associated with favorable early outcomes; however, longer-term follow-up is required to confirm the durability of these results. Proximalization allowed by the SD-FET technique simplifies the surgical procedure of AAD with less periaortic dissection, fewer aortic arch wall resection and reduce surgery duration in normothermic condition, offering comparable benefits as a conventional FET. Further comparative studies between the SD-FET technique and conventional FET with distal anastomosis in zones 2 or 3 are warranted to better define their respective indications and long-term outcomes. Such analyses are currently in progress at our institution, both at a single-center and multicenter level.

Limitations and strength

The aortic remodeling is a dynamic process with perpetual evolution. Therefore, our follow-up period is brief to fully capture the remodeling process. Longer follow-up and larger cohort are mandatory to shed more light on this issue. Moreover, the limited number of patients, the retrospective design of the study, the absence of comparative group and the learning curve with this new surgical technique with the technique was left to the discretion of the operator are also significant limitations to our results. Three patients (10%) underwent TEVAR before or after the index SD-FET procedure. These cases were included in the analysis, as such reinterventions reflect the natural course and management of extensive aortic dissection and did not directly impact the proximal remodeling outcomes, which constituted the primary endpoint.

Conclusions

The SD-FET technique presents acceptable early and one-year clinical results in AAD context. This technique allows us to simplify surgical procedure, reduce circulatory arrest and normothermia with safe outcomes. Regarding the aortic remodeling, this FET proximalization presents high rates of FL thrombosis and positive aortic remodeling at the stent-graft level. Remodeling and FL thrombosis in the downstream aorta were less pronounced. To better explore clinical long-term outcomes, a larger cohort and a longer follow-up are required.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-aw-600/rc

Data Sharing Statement: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-aw-600/dss

Peer Review File: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-aw-600/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-aw-600/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 retrospective single-centre study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. It is not classified as research requiring formal ethical approval under French law or European guidelines (definitions at www.emea.europa.eu). The clinical data were recorded in an anonymized database and patients gave their written consent for their data to be recorded.

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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