Frozen elephant trunk: a narrative review of global and temporal trends

Introduction

Unlike aortic valve disease, where decades of randomized trials and structured guidelines define surgical and transcatheter management, aortic arch disease remains an area of heterogeneous practice with limited high-level evidence. In many ways, the field resembles aortic valve management several decades ago: rich in surgical expertise, but still lacking robust evidence, clear definitions, and quality metrics. The complex nature of aortic pathology, its broader disease spectrum, and the evolving evidence base make aortic disease more nuanced and variable, particularly in the relatively rare conditions of arch aneurysm/dissection and in its niche procedure, the frozen elephant trunk (FET).

FET facilitates the management of complex aortic arch and descending aortic pathologies (1). Revolutionizing the conventional elephant trunk (cET) concept (2-7), Kato et al. described an arch graft anastomosed to a self-expanding covered stent graft made of nitinol, deployed antegrade in 1996 (8,9). The first commercially available FET prosthesis, the European made Chavan-Haverich device, became available in 2001 (10,11). Procedural indications soon expanded from degenerative aneurysm to aortic dissections (12,13). While FET has been adopted across Europe, Asia, North America, and beyond, global adoption has been influenced by region specific factors, including device availability, device iteration, government regulation timelines, and distinct patient populations (Figure 1). Even within the same region, practice patterns have significant variation, leading to ongoing debates and a need for a broader consensus of its role (1). Thirty years after its inception, the FET procedure is dynamically exploring its role under the mission of “lifetime management” of aortic disease. This narrative review aims to compile and synthesize the current literature on FET and to provide our perspectives on establishing best practices. We present this article in accordance with the Narrative Review reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1-2796/rc).

Figure 1 Frozen elephant trunk device timeline. FDA, food and drug administration; FET, frozen elephant trunk.

Methods

Authors searched PubMed, Google Scholar and International Clinical Guidelines for English-language adult studies published from January 1, 2010, through September 10, 2025 using the search strategy detailed in Table 1. Combined search terms included: frozen elephant trunk, stented elephant trunk, total arch replacement, E-vita Open, E-vita OPEN NEO, Thoraflex Hybrid, Frozenix, Cronus, acute type A dissection, chronic dissection, arch aneurysm, mortality, stroke, spinal cord ischemia (SCI), and reintervention. Authors included adult series that performed the FET procedure, and that reported at least two early endpoints of 30-day or in-hospital mortality, stroke, or SCI. Eligible reports also had to provide at least two operative details, such as distal anastomosis zone, cerebral perfusion strategy, hypothermia target, stent length or distal landing level, left subclavian artery (LSA) management, or primary cannulation site. Historical studies outside of the search window were included when necessary to illustrate temporal trends. A PRISMA flow diagram outlining the search process can be found within the supplemental materials (Figure S1).

Regional variations in FET procedure implementation

In Europe, Germany made innovative contributions to the field with the first hybrid prosthesis (Chavan-Haverich, 2001) (Figure 2), followed by the commercial production of the E-Vita series (Jotec Inc., Hechingen, Germany), which included the E-vita Open [2005] (Figure 3), E-vita Open Plus [2008], and most recently, the E-vita Open Neo [2020] (Figure 4) (11,14,16-18). The International E-vita Open Registry (IEOR), initiated in 2008 as the first large-scale, multicenter database for FET, encompasses 19 European centers and over 1,100 patients (19). With accumulating experience and technical refinement, postoperative complication rates have improved, specifically in the reduction of cerebral complications (9.9% before 2012 vs. 5.8% between 2012 and 2018) (Table 2) (19). A contemporary multicenter study of the E-vita Open Neo device reported a 30-day mortality of 5.1%, disabling stroke of 4.4%, and permanent spinal cord injury of 4.4% (20). Meanwhile, the Thoraflex Hybrid device (Terumo Aortic) was introduced in 2012 (Figure 5) (21,22).

Figure 2 Chavan-Haverich Prosthesis. Reproduced from Haverich and Karck (14). Available under Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0).

Figure 3 E-Vita Open Device. Available under Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0) (15).

Figure 4 E-Vita Open Neo Prosthesis. Reproduced from Acharya et al. (16). Available under Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0).

Figure 5 Thoraflex Hybrid Plexus Device. Reproduced from Acharya et al. (16). Available under Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0).

Experienced single center and large-scale multi-center studies showed comparable results with these two commercially available devices, with perioperative (in-hospital or 30-day) mortality of 1–15% for elective cases and that of 10–20% for acute type A aortic dissection (ATAAD). Stroke and spinal cord injury rates are <10% and <5%, respectively, and again higher with ATAAD (21,23,24).

Despite pioneering early FET devices, the operation is infrequently used in Europe. A UK study using the National Adult Cardiac Surgery Audit (NACSA) examined ATAAD and found that only 68 out of 4,203 (1.6%) surgical repairs between 2009 and 2018 were FET (25). The UK Aortic Group, comprised of 8 high volume centers, only performed a total of 66 FET operations between all sites from 2013–2017, however with excellent outcomes (26). More broadly, a study using the European Registry of Type A Aortic Dissection (ERTAAD) from 18 surgical centers revealed that FET was used only 2.7% of the time (27). Although no literature directly comments on Europe’s limited FET adoption despite early device approval, a 2015 European Association for Cardio-Thoracic Surgery (EACTS) position paper on the procedure notes that “several years typically pass before a critical appraisal and a balanced opinion of a new treatment method are available” which may suggest that in Europe, cautious utilization is typical for more novel procedures until stronger guidelines and expert opinions are more firmly established (28) (Table 3).

After the first global report of open stent grafting in 1996, the FET procedure in Japan did not undergo further evolution until the introduction of the Frozenix J-Graft in 2014 (Lifeline Co, Ltd., Japan) (35,36) (Figure 6). Since that time, however, utilization has increased dramatically, with over 12,000 Frozenix prostheses implanted by 2020 (35). This increase in utilization reflects the device’s simplification of the procedure, early device approval, and favorable early outcomes (37). Frozenix was initially used more frequently for non-dissection thoracic aortic aneurysms (50% of cases vs. 33% for ATAAD); however, by 2020, 51% were used for ATAAD and 41% for non-dissection aneurysms (38). A 10-year study with 435 FET patients between 2014 and 2023 revealed an in-hospital mortality rate of 5.1%, a neurological deficit rate of 5.8%, and a rate of SCI at 1.1% (37). By 2023, 20% of all thoracic aortic repairs were FET, with over half being indicated for dissection (39). The Japan Cardiovascular Surgery Database also showed that, among nearly 30,000 patients with type A dissection between 2013 and 2018, 9% had undergone FET, with higher percentages (12%) after 2014 (40,41) (Figure 7). In comparison, Society of Thoracic Surgeons (STS) data showed that in the United States, FET was utilized in 3.9% of thoracic aortic repairs in 2018 and rose by only 0.5% by 2023 (42) (Table 4).

Figure 6 Frozenix J-Graft highlighting the Dacron Polyester prosthesis supported by overlapping Nitinol stents. Reproduced from Chubani and Yoshitake (36). Copyright permission to reuse not required by Thieme (open access) under the creative commons CC by license.

Figure 7 Rapid adoption of frozen elephant trunk in Japan.

Currently, China utilizes FET most aggressively. China’s FET development is highlighted by Sun’s procedure (50), a variation which combines total arch replacement using a custom tetrafurcated graft with the antegrade deployment of a specialized stented graft, the Cronus. Sun’s procedure, from its inception in 2002, has been utilized for acute aortic dissections and was rapidly adopted with over 8,000 procedures by 2013 (50-53). A large Chinese study of 1,672 acute type A repairs reported an operative mortality of 6.3% and a 10-year survival rate of 81.4% (54). The Registry of Type A Aortic Dissection, a subsection of the Chinese Cardiac Surgery Registry (CCSR), reported 1,058 cases between 2018 and 2021, with 76% of those patients undergoing FET (55). Large multicenter Chinese studies in ATAAD between 2016 and 2021 reported FET usage ranging from 48% to 78% (56) (Table 5).

In North America, prior to the U.S. Food and Drug Administration (FDA)’s authorization of the Thoraflex Hybrid in 2022, US surgeons relied on off-label, self-made combination grafts (63). The multicenter Investigation Device Exemption (IDE) trial for the Thoraflex Hybrid reported its 1-year outcomes from a primary cohort of 65 patients. The all-cause mortality at 1 year was 11%, which included two operative mortalities (3%). The rate of permanent stroke was 5%, and the rate of permanent paraplegia or paraparesis was also 5% (64). The STS Adult Cardiac Surgery Database (ACSD) database showed that the total number of US FET performed has more than doubled between 2018 and 2023; however, the procedure encompassed only 3.9% of ascending/arch procedures in 2018 and 4.6% in 2023 (42). The Canadian Thoracic Aortic Collaborative (CTAC), compromising 9 high-volume aortic centers across the country, reported 2,520 patients who underwent arch repair between 2002 and 2018. Of these, 172 (7%) received FET, with the majority presenting with an acute dissection (65,66). Most operations were completed using the Thoraflex or E-Vita OPEN graft. Outcomes mirror those of other regions, including an in-hospital mortality rate of 9%, stroke rate of 13%, and a permanent SCI rate of 2.3% (Table 6).

In the literature, a few distinct geographical regions have emerged as supporters of FET despite relatively lower aortic volume or resource availability, making these an important insight into how procedural innovation spreads on a global scale. Korean centers reported exceptional results: 167 patients who underwent the FET procedure between April 2021 and March 2023 from the Gangnam Severance Aortic Registry showed an in-hospital mortality rate of 1.8%, a stroke rate of 1.8%, a SCI rate of 1.8%, and a 1-year survival rate of 95.9% (71). The Korean FET experience is centered exclusively on the E-vita Open Neo device. Excellent outcomes in Korea may be due to their delayed entry into the field, combined with the use of a third-generation device from the outset, allowing aortic centers to bypass earlier device iterations and techniques, and adopt standardized global principles early on. Emerging FET programs in other regions are likely to also benefit from adoption of the technical advancements made at high volume centers such as proximalization to zone 2 and more liberal use of extra-anatomical LSA bypass, both of which can ease the learning curve and enable good results at low volume centers (72) (Table 7).

Brazil has the most experience in FET in Latin America, with E-Vita Open approval in 2009 (74). A recent report of patients between 2009 and 2023 shows a nearly doubling in annual case volume, with a total cohort of approximately 160 patients and a 30-day mortality of 14.5% (75). Unique to Brazil, the main indication for FET is chronic aortic dissection. In Turkey, FET was first described in a single-center study of 41 patients with ATAAD between 2013 and 2017 (76). All patients received E-Vita Open Plus hybrid graft. The in-hospital mortality rate was 14.5% (77). Additional postoperative complications, including neurological events and SCI, were well in line with current literature (78). A recent study from Vietnam describes their experience with a modified FET technique that was utilized in 47 patients between 2019 and 2023 (79,80). The modified technique, which includes physician-constructed grafts, warmer hypothermia targets, and distal anastomosis in zone 1, was reportedly driven by local circumstances, such as the high cost and inconsistent availability of commercially available hybrid prostheses. In their cohort, average circulatory arrest time was just 32.6 minutes (vs. 46 minutes in recent systemic reviews), perioperative mortality rate was 10.6%, neurological event rate of 8.5%, and 0 patients experienced SCI, demonstrating that physician constructed grafts can produce comparable results to commercial devices while addressing issues of cost and availability (81). While Egypt and other middle-income countries have published FET literature, all have used commercially available prostheses making the Vietnam experience a unique and reproducible model for resource constrained environments (82). This represents an excellent example of innovation, resilience, and ingenuity as it relates to global health equity in cardiac surgery.

Lessons learned

FET-advantages

The FET procedure facilitates arch surgery by proximalization of the distal aortic anastomosis and through enhanced hemostasis at the anastomosis. For ATAAD, in addition to closure of an entry in the proximal descending aorta, it induces favorable distal aortic remodeling (81). FET promotes thrombosis of the false lumen (FL) within the stented segment in greater than 90% of patients, with meta-analysis demonstrating FL thrombosis rates of 96.8% in ATAAD patients (83,84). Complete FL thrombosis is achieved more reliably in patients with acute dissection (94%) compared to those with chronic dissection (86%), however some smaller studies have reported nearly double the rate of FL thrombosis in acute vs. chronic dissections (16,85). Combined partial/complete thrombosis of the peri-stent aorta is also noted to occur in approximately 90% of patients (86). Thrombosis rates have been shown to progressively diminish distal to the unstented segment, with FL patency noted 52% at the level of the diaphragm and 78% at the celiac trunk, demonstrating a clear proximal to distal gradient (87).

FET facilitates positive aortic remodeling, which includes true lumen expansion and FL shrinkage. Although aortic remodeling occurs at all downstream aortic segments (87-89), this change is most pronounced at level of the stent graft, with the diameter of the true lumen capable of expanding from 15±17 mm before surgery to 28±2 mm at 2 years post-operative (P=0.001), and the diameter of the FL has decreasing from 40±11 to 32±17 mm (P=0.026) (88). Similar to thrombosis rates, positive aortic remodeling has been reported in 90% of patients with acute dissections and 78% of those with chronic dissections (16). These anatomical changes convey favorable long-term outcomes, including an overall survival rate of 89.6%, 85.2% and 82.0% at 1, 3 and 5 years, respectively in large systematic reviews (81). The freedom from distal aortic reintervention has also been reported in 93.9%, 89.3%, and 86.8% of patients at the same time points (81). Studies comparing FET to cET have shown the former resulting in lower rates of reintervention (3.6% vs. 39.1% at 5 years), with equivalent long-term survival stroke and renal failure (90,91). In patients with multi organ malperfusion, the addition of FET to hemiarch repair improves 5-year survival compared to hemiarch alone (68% vs. 32%) (92). By augmenting the true lumen flow, FET may improve visceral or leg malperfusion; however, these conceptual benefits in critically ill patients with malperfusion need to be balanced against the increased risks associated with extended operation times (88).

FET-associated complications

Cumulating experience and data continue to shape the understanding of complications unique to the FET procedure. SCI, a most serious FET-associated complication, occurs in 3% to 4.7%. Key risk factors include extended coverage of the descending thoracic aorta (DTA) (stent grafts ≥15 cm or extending to T8 or below), postoperative hypotension, diabetes, prior aortic surgery, and atherosclerotic disease, as well as prolonged hypothermic circulatory arrest time and warmer body core temperature during arrest (≥28 ℃) (78,93-95). Prophylactic cerebrospinal fluid drainage (CSFD) is a strategy used to mitigate the risk of SCI during FET; however, its efficacy is still controversial. A clear benefit for CSFD in randomized trials has been found in patients undergoing open thoracoabdominal aneurysm repair (96), while CSF drainage has not been shown to mitigate SCI risk in those undergoing thoracic endovascular arch repair (TEVAR) (97,98). Recently, a large study from China looked at prophylactic CSFD for FET which showed that specific patients who were deemed high risk (defined as >60% of their intercostal arteries between T8 and T12 originating from the FL) had significantly less SCI than those who did not receive drainage (61). Therefore, current literature suggests that CSFD for FET should be determined based on patient anatomy and risk for SCI.

Stent graft-induced new entry (SINE) is characterized by a new intimal tear at the distal edge of the stent graft. Affecting 2% to 23% of cases, distal SINE (dSINE) is a complication that typically presents months to years after the FET procedure, rather in the hyper acute post-surgical window (99,100). When dSINE occurs, it typically requires management with TEVAR. Importantly, stent graft sizing affects risk: oversizing relative to the true lumen leads to circumferential stress concentration and wall injury, whereas undersizing increases wall shear stress (101,102). In addition, device-specific factors, such as the stiffness of the distal ring (with Thoraflex) and subsequent movement or elastic recoil of the stent graft over time, further contribute to the likelihood of dSINE (99). To minimize this risk, careful sizing, landing the stent graft in a straight segment of the descending aorta, and understanding the characteristics of the chosen stent are essential.

Stent thrombosis following FET procedure is increasingly encountered, with a pooled incidence of 8–9% (103). Most cases are diagnosed with CTA within the first postoperative week and may lead to distal emboli and mortality. In addition to patient factors, such as hypercoagulable status, device-related factors, such as stent-graft diameter index, and longer stent grafts, as well as anatomical features, such as degenerative aneurysm, anticipated type Ib endoleak, and slow-flow zones, are established risk factors (103-106). Preoperative planning using 3D centerline imaging software to measure true aortic length and predict stent graft termination site has become essential for device length selection, balancing adequate distal coverage with minimization of thrombosis and SCI (107). Most stent thromboses resolve with anticoagulation, though TEVAR extension or open thrombectomy may be required. There is currently no consensus on prophylactic post operative anticoagulation. For example, Ibrahim et al. discharged all FET patients on single antiplatelet therapy and only anticoagulated those with evidence of stent thrombosis, while Martens et al. anticoagulated all patients with high risk factors for stent thrombosis regardless of early CT imaging findings (104,106).

Developing consensus

The 2022 American Heart Association and American College of Cardiology Aortic Disease Guidelines recommend that the FET procedure may be considered in patients undergoing open surgical repair of an aortic arch aneurysm when the aneurysmal disease extends into the proximal DTA (class IIb, level C-LD) (108). The European Society of Cardiology (ESC) 2024 Peripheral Artery and Aortic Disease (PAAD) guidelines recommend the FET technique for ATAAD and a secondary intimal tear in the arch or proximal DTA, extended aortic repair (class IIb, level C); for open surgical repair of an aortic arch aneurysm if the aneurysmal disease extends into the proximal DTA (class IIa, level C) (109). The 2024 EACTS/STS guideline recommended the FET technique for one-stage aortic arch treatment (class IIa, level B), acute complicated type B aortic dissection with unsuitable anatomy for TEVAR (class IIa, level B), arch pathologies and diseased aortic segments distal to zone 2 (class IIa, level B), for >50 mm chronic aortic dissection if the treatment includes a multistep procedure with zone 2 FET followed by TEVAR (class IIa, level C) (110). The 2020 Japanese Circulation Society Guidelines recommended that total arch replacement with FET may be considered for ATAAD complicated by malperfusion and in patients with extensive aneurysm of the aortic arch (111).

The lack of class I or even class IIa/IIb recommendations highlight the ongoing ambiguity and heterogeneity around this procedure. Since 2015, Chinese surgeons have performed nearly 100,000 Sun’s procedures nationwide with FET serving as the primary treatment approach for ATAAD (41099002). Similarly, Japan has been using FET since the 1990’s with an even heavier reliance once the Frozenix device was created for this market. Conversely, Western practices have been much more conservative. Prior to 2022, no commercial device approval existed, forcing surgeons to create off label modifications or continue utilizing two-stage cET (64). Centers in Europe, despite device approval since 2005, have also adopted FET at a much slower rate than those in Asia. These differences are likely multifactorial including regulatory barriers (particularly in the US), different patient demographics (Chinese ATAAD patients are on average a decade younger than those collected in the International Registry of Acute Aortic Dissection (IRAD) database), variations in institutional volume and experience, and lack of clear guideline evidence to require conformity (112). Therefore, the IIa/IIb guideline recommendations not only represent genuine clinical equipoise but also allow for the continuation of divergent regional practices until definitive comparative data is produced (Table 8).

An uncritical application of these guideline recommended indications could be hazardous. Plausible consideration of device availability, cost, surgical expertise, and experience with other relevant procedures is required. For instance, in the absence of surgical expertise, hemiarch replacement may be more appropriate in ATAAD, which may be followed by elective referral to a high-volume aortic center if the residual dissection leads to chronic aneurysm.

Refining surgical technique

Recent studies have demonstrated increased FET utilization for aortic emergencies such as ATAAD, reduced circulatory arrest times, and decreased rates of postoperative cerebral and spinal cord complications (19). These differences may reflect the temporal standardization of protocols, which extend beyond surgical technique and represent a comprehensive, multidisciplinary optimization of the entire perioperative process (19,113). Initially conceived as a single-stage repair, it is now widely used as a platform for the staged management of extensive aortic disease. Coselli et al. recently showed that 41% of their FET patients underwent planned second-stage extension within 1 year, more than double the rate reported in some contemporary series (17,64). This has driven a preference for shorter stented segments that effectively create a stable and reliable proximal landing zone for potential future endovascular completion with TEVAR while minimizing the risk of spinal cord injury (16,114).

Contemporary surgical technique includes moderate hypothermia with selective antegrade cerebral perfusion (SACP) (115), proximalization of the distal anastomosis from zone 3 to zone 2 when feasible (37,116), shorter stented segments (less than 150 mm), and a proximal distal landing level at or above T7 (37,117). LSA revascularization should be pursued to mitigate the risks of posterior circulation strokes, SCI, and left arm claudication (118), and can be managed with direct end-to-end anastomosis to a dedicated branch of the arch graft, bypass between LSA and the left carotid artery, stenting into the LSA, or transposition of the LSA to a more proximal location. Lastly, the graft size is typically oversized by 10–20% relative to the native aorta’s diameter in aneurysms, undersized by more than 10% in acute dissections, and true to true lumen diameter in chronic dissections (110,119,120). The optimal length of the stented graft is determined by the distal landing zone, which, when extended distal to T8 (or approximately 15cm total stent length), is associated with significantly higher rates of SCI due to additional coverage of collateral vessels that feed the anterior spinal artery (78,121). While better for spinal cord perfusion, shorter stented segments may not provide adequate coverage for distal entry tears and may increase the likelihood of aortic reinterventions (21,34). This balance aims to maximize true lumen expansion without impeding spinal cord perfusion (20,35,122,123). Distinctly different regional cohorts, such as the Korean and European NEO reports, as well as U.S. Thoraflex reports, have converged on these technical standards, suggesting that device evolution and shared technical choices, rather than geography alone, account for a significant portion of the temporal improvement in outcomes observed globally (20,64,71).

Finally, multicenter registries with long-term data have consistently demonstrated a clear relationship between case volume and patient outcomes (19,113). High volume centers, defined in the IEOR as centers performing >50 cumulative FET operations or >10 cases annually, demonstrated superior 30-day mortality (11% vs. 15.3% P=0.048) and 6-year survival (63.3% vs. 56.1% P=0.014) compared to those not meeting this threshold (19). Low-volume centers used standard techniques (i.e., right axillary cannulation, bilateral cerebral perfusion) less often (P=0.048 and P=0.004, respectively) had significantly longer operative times [cardiopulmonary bypass time (CPB) time, P=0.004; cross clamp time, P=0.002; SACP time, P<0.001; ischemia time, P<0.001], and had higher cardiac complications, such as low EF (14.1% vs. 9.0%, P=0.015) and re-explorations for bleeding (16.2% vs. 11.7%, P=0.043) (19). Of note, specific volume thresholds vary across studies, however the relationship between the frequency of FET utilization and outcomes, remains consistent.

The volume outcome relationship has also been corroborated in single center studies demonstrating a quantifiable learning curve effect, including a 9-year Brazilian series showing progressive improvements in mortality over time, and an 8-year Polish experience reporting 50% reductions in operative and CPB times by the end of the study period (33,113).

Institutional advancements from high volume centers

Although many institutions have employed the technical strategies previously described, some have adapted unique protocols at large volume centers to improve patient outcomes. The UK Aortic Group, consisting of eight such centers, including Royal Papworth Hospital, the country’s most experienced FET institution, has championed the use of a bilateral axillary cannulation strategy. This technique improves flow to the posterior circulation, allows for continuous perfusion during circulatory arrest, more evenly distributes perfusion pressures reducing strain on the axillary arteries, and necessitates only 1 additional cannula to the left common carotid artery for antegrade cerebral perfusion (124,125). Of their 109 patients who were perfused with this technique, there was a 0% incidence of SCI, 11% incidence of permanent stroke and 0.9% incidence of laryngeal nerve palsy, all three of which are lower than those reported nationally within the UK (26). Recently, the UK Aortic Group has further advanced its cannulation strategy by incorporating bilateral axillary cannulation with pre-circulatory arrest arch vessel debranching, which significantly reduced their circulatory arrest and cross clamp times (125).

The Hannover group was the first to develop the “beating heart” arch replacement technique which allows for continuous myocardial perfusion, without the use of cardioplegic arrest, with the goal of minimizing cardiac ischemia time (126). To do so, the left ventricle is deaired and the heart is perfused in an antegrade fashion through a multi branched cannula placed proximal to the aortic cross clamp, enabling simultaneous yet separate perfusion systems for the head, heart and lower extremities. Ultimately, this allows for work to be done on the arch while the heart continues beating. Beating heart technique, in combination with carbon dioxide insufflation and perioperative CSFD has resulted in improved in hospital mortality rates from 15% in early series to 8% in current era studies (127). Recent adoption of this technique by other European centers has resulted in similar decreases in cardiac ischemia time (128).

The Essen group developed a technical modification they refer to as “four sites perfusion” which is an extension of bilateral axillary perfusion that adds an additional selective perfusion site to LSA and represents what the authors call a ‘take no chances’ approach to cerebral perfusion (24). When combined with zone 2 anastomosis, four sites perfusion demonstrates protective effects against the composite endpoint of major adverse events and 5-year survival (24). The development of these center specific advancements highlights the continued evolution of FET for complex arch repair (Table 9).

Relevant innovations

Overall, global convergence and regional differences may be highlighted by the status of commercial device approval: E-Vita (Jotec Inc., Hechingen, Germany, 2005) and Thoraflex (Terumo Aortic, 2012) in Europe, Cronus graft in China (Microport, 2003), Frozenix graft (Japan Lifeline, 2014) and Thoraflex [2023] in Japan, and Thoraflex in the US [2022]. During such “device lag”, technological advances and collaboration with vascular surgery have cultivated relevant innovations.

Branched stented anastomosis frozen elephant trunk repair (B-SAFER) is a FET variation that, based on pathology, anatomy and clinical context, facilitates a distal anastomosis at either zone 1 or 2, supplemented with one or more stents for head vessels. Roselli et al. prospectively evaluated 178 patients undergoing total arch replacement using this technique and reported an operative mortality 5.6%, disabling stroke 2.9%, paraplegia 0.6%; 1-year survival 79%, demonstrating early safety and reproducibility (68).

In China, Fontus Branched Graft (Microport), which incorporates a single branch structure to facilitate LSA reconstruction without deep anastomosis (129), showed non-inferiority to the established Cronus graft, with similar morbidity and mortality, but shorter cerebral perfusion times (130). In the US, a trial of a branched FET device (Arcevo LSA stent graft) started in November 2025.

Sutureless Integrated Stented (SIS) graft prosthesis is another innovation from China, featuring a self-expanding nitinol ring that presses against the inner wall of the aorta to create a seal. An externally wrapped elastic band and a tightening mechanism enable the graft to be anastomosed without suturing, reducing circulatory arrest (CA) time (131,132). The first clinical data of 10 showed no operative mortality, stroke, or SCI with a mean circulatory arrest time of 9 minutes (131).

Zone 2 arch replacement is increasingly utilized in the US as an alternative to more extensive procedures (42,133). The distal aortic anastomosis is not significantly different from hemiarch replacement with additional supra-aortic artery reconstruction, for which dedicated grafts are commercially available. The primary advantage of zone 2 arch replacement is the creation of a sufficient proximal landing zone for staged endovascular repair of the descending aorta. With the recent availability of branched endovascular arch devices, patients can undergo completion TEVAR without additional open procedures or the technical complexity of FET. This staged approach is particularly valuable when there is progressive pathology in the descending aorta, such as true lumen collapse, persistent FL perfusion in chronic dissection, or aneurysmal degeneration (133). Recent single center studies of TEVAR extension after zone 2 arch replacement have reliably shown stabilization or reduction in aneurysm size, and FL thrombosis in all cases indicated for dissection (134,135). Although rare, primary complications include disconnection between arch graft and TEVAR component, and type IC endoleak requiring secondary fenestrated stent graft repair (136,137). Patient selection regarding FET vs. zone 2 arch replacement depends on specific clinical and anatomic factors (138,139). FET is indicated when the primary entry tear is in the distal arch or proximal descending aorta especially if there is true lumen collapse or malperfusion. Conversely, if the primary entry tear is in the ascending aorta with normal arch and DTA diameters, zone 2 replacement can provide adequate repair while minimizing operative complexity (138). Procedural approach is further influenced by patient age and physical condition such that FET is typically only considered in younger patients (<75 years) who have a higher likelihood of tolerating the additional circulatory arrest times (140). In our practice, at times, intraoperative assessment may guide decision making on zone 2 vs. zone 3 anastomosis. For example, a very deep or challenging LSA anastomosis, anomalous vertebral artery anatomy, and downstream aortic anatomy that seems feasible for reintervention may push the anastomosis more proximally to zone 2. On the other hand, an angulated arch which may compromise future TEVAR seal with a straightforward distal arch and LSA anastomosis makes a zone 3 anastomosis more attractive.

The evolution of branched endovascular devices for zone 0 arch repair presents an important alterative to FET, particularly for patients who may not tolerate open surgery, as this approach mitigates the need for circulatory arrest or CPB. A series of branched stent grafts has been introduced for such patients including the NEXUS Aortic Arch Stent Graft System (Artivion Inc., Kennesaw, GA, USA) which is a modular system with a pre-fashioned single branch device (single branch stented arch graft and docking sleeve seated in the ascending aorta), designed for zone 0 landing with deployment from the brachiocephalic trunk (BCT) (141). Preparative supra-aortic debranching (carotid to carotid bypass or carotid to subclavian) is required prior to NEXUS deployment to maintain cerebral perfusion through the BCT. A multicenter study reported 1- and 3-year survival rates of 89% and 71%, and incidence of unplanned reintervention of 11% and 29% respectively, with only a single patient experiencing type IIIb endoleak occurring between the two components of the NEXUS graft (142). The Gore TAG Thoracic Branch Endoprosthesis (TBE) (W.L. Gore and Associates, Flagstaff, AZ, USA), which uses a single retrograde branch, had its FDA approval expanded for zone 0/1 endovascular arch repair in 2025. A recent multicenter study of zone 0 repair with Gore TBE showed no aortic-related deaths, reinterventions, loss of side branch patency, or aneurysm enlargement at 3 years, however, the stroke rate was 22% (143). The Cook Zenith Arch Branch Endograft (Cook Medical, Bloomington, IN, USA) which offers a multi branched system, is the current gold standard for endovascular total arch replacement at experienced centers, although long-term outcomes remain limited to small sample sizes (144). The Zenith has been available in Europe since 2012 and is under FDA IDE status in the USA (145). As these technologies mature, they may increasingly replace FET for patients with isolated arch pathology, though comparative effectiveness studies are needed (Table 10).

Lastly, physician modified arch grafts (PMAGs) represent a specialized option for zone 0 endovascular repair, in which standard thoracic endografts are intraoperatively modified with custom fenestrations and/or inner branches. This approach is particularly valuable in emergent settings, where patients are anatomically unsuitable for off-the-shelf branched devices and the time required for manufacture of custom-made devices is prohibitive. A systematic review of 239 patients looked at the efficacy of PMAGs for arch pathology and reported a technical success rate between 93.7% and 98.3%, 30-day mortality of 2.9% and stroke/transient ischemic attack (TIA) rate of 2.1% (149). Champion vascular surgeons such as Stefan Haulon, Ludovic Canaud, and Tilo Kölbel have pioneered PMAG techniques with impressive outcomes. In 2020, Kölbel published a series of 44 arch patients for whom he had constructed PMAGs with a 30-day mortality, stroke, and SCI rate of 9%, 7% and 7% respectively, and a 2-year survival rate of 78% (150). Canaud, Haulon, and their colleagues in France have published extensively regarding their experience with PMAGs, showing technical success rates between 91–98%, 30-day mortality and stroke rates of 2–6%, and midterm reintervention rates of 4–17% most often for endoleak or distal extension of the repair (151-153). Open arch repair and subsequent TEVAR with these advanced devices allows many creative pathways in treating complex aortic pathologies.

Finally, the Ascyrus Medical Dissection Stent (AMDS; Artivion^®, Atlanta, GA, USA) is a hybrid device for type A aortic dissection that promotes aortic arch remodeling, reduces distal anastomotic new entry tears, and effectively manages malperfusion with low mortality and favorable short and mid-term outcomes (154,155). It integrates into standard hemiarch repair without significant procedural extension and facilitates branch vessel perfusion, showing promise as a less invasive alternative to total arch replacement in select clinical scenarios.

Need of emphasis on long-term outcomes

Despite the increase in global FET utilization, comparative long-term data beyond 5 years remains limited, with the largest systematic reviews reporting average follow-up times of 3–4 years and pooled 5-year survival rates of 78–82% (81,156). Select single center studies have provided outcome data extending beyond that including Hannover, Germany (58%±8%), Vienna, Austria (53.0%±5.5%), and Beijing, China (81.4%), the last of which had patient follow-up extending past 13 years (11,29,54).

In aortic surgery, data-driven quality assurance of surgical practice might uniquely influence surgical decision-making. For example, in the US, where operative mortality is reported and monitored, for ATAAD, hemiarch replacement might be chosen over total arch replacement with FET to minimize operative risk even at the expense of increased long-term morbidity. The literature flags public-reporting-driven risk aversion as a real behavioral force in cardiac procedures (157). The 2019 American Association for Thoracic Surgery (AATS)/American College of Cardiology (ACC)/American Society of Echocardiography (ASE)/Society for Cardiovascular Angiography and Interventions (SCAI)/STS Expert Consensus Document notes that public reporting of risk-adjusted outcomes, such as those from the STS, can lead to risk avoidance and conservative case selection, potentially excluding patients who might benefit from surgery but are at higher operative risk (158).

Beyond public reporting, the broader shift toward value-based care models raises questions about how complex procedures like FET should be evaluated and reimbursed. A value-based care model aligns reimbursement with patient centered outcomes relative to the total cost of care across an episode, rather than procedural volume or intensity (159). Within this framework, FET repair may occupy a limited but justifiable role. Despite substantial resource utilization and perioperative risk, FET can achieve durable single stage arch repair and reduce downstream reinterventions in carefully selected patients. The marked inter-center variability reported in registries and large institutional series highlights the critical importance of appropriate case selection and standardized perioperative strategies. When applied within such frameworks and associated with acceptable complication rates and fewer secondary procedures, FET may potentially be considered a high value intervention rather than a high-cost outlier.

However, this value proposition remains largely theoretical in the absence of rigorous economic data. Despite the expanding use of the FET technique, published data evaluating its economic implications remain limited. Existing studies predominantly emphasize perioperative outcomes, technical feasibility, and mid-term reintervention rates, while comprehensive analyses integrating index hospitalization costs, longitudinal surveillance, readmissions, and subsequent aortic reinterventions are still lacking. Consequently, the overall cost effectiveness of an upfront total arch replacement with FET, entailing greater initial resource utilization relative hemiarch, partial arch, or total arch alone approach followed by potential staged interventions remains unclear. Whether higher upfront costs are offset by reductions in downstream reintervention, readmission, and cumulative health care expenditures has not been adequately defined and represents an important knowledge gap in contemporary aortic surgery.

Finally, given the significant longitudinal risks of FET, reliable patient follow-up is a crucial factor in candidate selection. It is important to understand that guideline-recommended lifelong surveillance is not well executed in patients undergoing open aortic surgery. A single-center study of 559 found that only 39% complied with structured follow-up imaging (160).

Limitations

Major limitations are centered around the narrative nature of this review. Due to the heterogeneity of the published studies, including their differing patient populations, device eras, and length of follow-up, a comparative analysis was not feasible. Furthermore, although criteria for high-quality studies were implemented, the review was not systematic in nature and is therefore subject to selection bias. An additional limitation is that literature published on FET outside the English language was not included, which may fail to reflect the experiences of other developing countries that publish their data in languages other than English.

Conclusions

This narrative review synthesizes three decades of FET literature, highlighting the procedure’s evolution as well as the progress in establishing universal best practices. FET has fundamentally reshaped the treatment of complex diseases of the aortic arch, evolving from a specialty operation for thoracic aneurysms to a highly effective option for multiple pathologies, including ATAAD.

Utilization rates vary globally, with Asian centers relying on FET most frequently and Western Countries still consistently below 10% of all arch procedures. Technical convergence towards moderate hypothermia with SACP, zone 2 anastomosis, and shorter stents has improved outcomes, though a significant learning curve exists. For centers with limited experience, zone 2 arch replacement with staged TEVAR offers a viable alternative. Emerging branched and fenestrated endovascular devices provide less invasive options for select arch anatomies, though long-term data is limited.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the Narrative Review reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1-2796/rc

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1-2796/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1-2796/coif). H.T. serves as an unpaid editorial board member of Journal of Thoracic Disease from February 2025 to January 2027. D.P. is a consultant for TERUMO AORTIC, PETERS, and GORE, and received grants from CORCYM and ARTIVION. The other 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.

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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