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J Chest Surg 2024; 57(5): 419-429

Published online September 5, 2024 https://doi.org/10.5090/jcs.24.089

Copyright © Journal of Chest Surgery.

Next-Generation Frozen Elephant Trunk Technique in the Era of Precision Medicine

Suk-Won Song , M.D., Ph.D.1,*, Ha Lee , M.D.1,*, Myeong Su Kim , M.D.1, Randolph Hung Leung Wong , F.R.C.S.2, Jacky Yan Kit Ho , F.R.C.S.2, Wilson Y. Szeto, M.D.3, Heinz Jakob , M.D.4,†

1Department of Thoracic and Cardiovascular Surgery, Ewha Womans University Aorta and Vascular Hospital, Ewha Womans University Medical Center, Seoul, Korea; 2Division of Cardiothoracic Surgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China; 3Division of Cardiovascular Surgery, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 4Department of Cardiothoracic Surgery, West German Heart and Vascular Center, University Hospital Essen, Essen, Germany

Correspondence to:Suk-Won Song
Tel 82-2-6986-2110
Fax 82-2-6986-2111
E-mail stevensong@ewha.ac.kr
ORCID
https://orcid.org/0000-0002-9850-9707

*These authors contributed equally to this work as the first authors.
Current affiliation: Diagnosticum Mülheim, Mülheim, Germany

Received: August 23, 2024; Accepted: August 28, 2024

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

The frozen elephant trunk (FET) technique can be applied to extensive aortic pathology, including lesions in the aortic arch and proximal descending thoracic aorta. FET is useful for tear-oriented surgery in dissections, managing malperfusion syndrome, and promoting positive aortic remodeling. Despite these benefits, complications such as distal stent-induced new entry and spinal cord ischemia can pose serious problems with the FET technique. To prevent these complications, careful sizing and planning of the FET are crucial. Additionally, since the FET technique involves total arch replacement, meticulous surgical skills are essential, particularly for young surgeons. In this article, we propose several techniques to simplify surgical procedures, which may lead to better outcomes for patients with extensive aortic pathology. In the era of precision medicine, the next-generation FET device could facilitate the treatment of complex aortic diseases through a patient-tailored approach.

Keywords: Aortic diseases, Vascular grafting, Endovascular aneurysm repair, Endoleak, Spinal cord ischemia

Aortic diseases encompass a broad spectrum of disorders that affect a wide anatomical range, from the aortic valve to the abdominal aorta. Additionally, these conditions vary in their urgency, ranging from acute aortic syndromes, such as aortic dissection [1,2], to chronic conditions such as aortic aneurysms [3,4]. The pathophysiology of aortic diseases is equally diverse, including genetically driven conditions such as Marfan syndrome [5] and lifestyle-influenced disorders such as atherosclerosis. Additionally, aortic inflammation can result from bacterial infections or autoimmune diseases [6,7]. Given the aorta’s critical role in supplying blood to all organs, these conditions can lead to a wide array of symptoms and complications, including cerebral infarctions and lower limb ischemia [8]. Historically and in the present day, managing such a diverse and extensive range of aortic diseases has been challenging.

Among the most challenging areas in medical treatment are those involving extensive aortic pathology [9]. While localized aortic diseases can be managed more easily, the complexity of treatment increases significantly when the pathology extends over a larger anatomical area, requiring careful consideration of potential complications. The challenge of treating extensive aortic pathology has persisted, prompting ongoing exploration of surgical solutions. A significant advancement occurred in 1983 when Hans Georg Borst from the Hannover group in Germany developed the elephant trunk (ET) technique, initially used to address extensive aortic pathology. However, a major limitation of this technique was the requirement to perform the surgery in 2 stages [10].

The introduction of stent implantation in aortic diseases in 1994 marked a new era [11]. In 2003, the first attempt was made to integrate the ET technique with endovascular intervention [12]. This innovation was developed by the Hannover group, led by Hans Georg Borst, the pioneer of the ET technique. He performed the procedure under hypothermic circulatory arrest, incorporating endovascular techniques. The added rigidity from the stent led Borst to name this new method “frozen ET” (FET), inspired by the stent’s frozen appearance on imaging. The concept of FET took an additional 20 years to fully evolve, culminating in the integration of stent implantation.

This review article aims to discuss recent developments in FET, marking 40 years since the introduction of ET and 20 years since FET was first implemented. It covers indications, complications, preparation protocols, surgical tips, features of next-generation FET products, and the role of FET in the era of precision medicine. Additionally, the article will examine the characteristics of the Evita OPEN NEO, which has been available in Korea since April 2021.

It is useful to categorize the indications for the FET procedure based on the primary objectives of the treatment. There are 4 main purposes for which FET is performed: (1) addressing extensive aortic pathology, (2) implementing a tear-oriented surgical approach, (3) managing malperfusion syndrome, and (4) promoting aortic remodeling.

Frozen elephant trunk for extensive aortic pathology

Currently, there is no universally accepted definition of “extensive aortic pathology.” This ambiguity has resulted in the use of various terms in the literature, such as “complex aortic pathology [13,14].” To better understand the indications for FET in the context of extensive aortic pathology, it is essential to define the condition clearly to determine when FET should be applied.

For FET to be indicated, the aortic lesion must involve a specific anatomical region: the pathology must extend from the aortic arch to the proximal descending thoracic aorta (pDTA). This means that FET is appropriate for conditions such as an aneurysm, a primary entry tear causing dissection, a penetrating atherosclerotic ulcer (PAU), or a rupture point within this range.

The anatomical characteristics of such lesions present challenges for traditional surgical approaches such as median sternotomy or left thoracotomy, particularly when the pathology spans a broad area. While FET alone may not resolve all issues, it can facilitate subsequent operations or interventions. Although alternative surgical approaches, such as the clamshell incision or newer techniques, such as anterolateral thoracotomy with partial sternotomy, have been proposed, they have not gained widespread acceptance [15]. Therefore, FET is typically indicated for diseases involving the aortic arch and pDTA, and may also be considered when the pathology extends to the distal part of the pDTA. In situations where the lesion is confined to the proximal part of the arch and the pDTA, FET may be sufficient. However, if the distal pDTA is affected, additional thoracic endovascular aortic repair (TEVAR) or a second-stage operation may be necessary.

Frozen elephant trunk for a tear-oriented approach

Another critical objective of FET is the tear-oriented approach. The 2021 American Association for Thoracic Surgery expert consensus for the surgical treatment of acute type A aortic dissection recommends a tear-oriented approach and says that extended aortic arch replacement is reasonable when the primary entry tear is located in the arch or pDTA [16]. While the surgeon’s society recommends a tear-oriented approach explicitly, the 2022 American College of Cardiology/American Heart Association guidelines do not explicitly address tear-oriented surgery in acute type A aortic dissection, but they do indirectly suggest this approach [17]. Initially, the guidelines recommend opening the distal end of the dissection to directly visualize the tear. This suggests that adopting a tear-oriented approach in cases of acute type A aortic dissection is impractical if the tear is located on the lesser curvature. Furthermore, the guidelines indicate that if the entry tear is not located in the arch or pDTA, a hemiarch repair (HAR) may be sufficient. This approach minimizes the extent of surgery, thereby reducing postoperative complications and mortality. However, if the tear is situated in the arch or pDTA, the surgical scope must be expanded to include total arch replacement (TAR). This expansion increases both the operative time and the risk of complications, whereas HAR would leave the tear unresolved.

In such dilemmas, FET offers a practical solution by effectively covering the entry tear with a stent-graft. FET is especially beneficial in acute type B dissections that are complex and not amenable to TEVAR, as well as in non-A non-B dissections where the primary entry tear occurs at the pDTA. This approach is also applicable in instances of PAU or aneurysm rupture at the pDTA.

Frozen elephant trunk for malperfusion syndrome

Malperfusion syndrome occurs when organs and tissues receive insufficient blood flow, resulting in ischemia and the potential for organ dysfunction or failure. This condition is linked to high morbidity and mortality rates in both acute type A and type B aortic dissections. FET has emerged as an innovative treatment option for malperfusion syndrome, as it promotes the expansion of the true lumen and covers the primary entry tear in the arch or proximal DTA.

Yang et al. [18] recommend an “intervention-first” approach for some type A dissection cases, a strategy that is also supported by recent guidelines when there is malperfusion of the celiac artery or superior mesenteric artery. However, this approach may not be feasible when there is a collapse of the true lumen at the DTA level without a re-entry tear. In such scenarios, the intervention might require creating a fenestration in the flap to decrease false lumen pressure and restore true lumen pressure, although this procedure carries a risk of rupture [19]. Therefore, TAR with FET (TARFET) may be necessary to address malperfusion syndrome by covering the primary entry tear.

Frozen elephant trunk for aortic remodeling

The concept of aortic remodeling gained prominence in the late 2000s, especially in the context of acute type B dissections. This interest largely stemmed from observations of changes in the diameters of the true and false lumens following TEVAR [20]. Research into aortic remodeling after TARFET was initiated by studies such as the one conducted by Iafrancesco et al. [21]. Aortic remodeling can be categorized into 3 types: (1) positive, (2) negative, or (3) stable. Positive aortic remodeling is characterized by the expansion of the true lumen and the formation of thrombus in the false lumen, which leads to a reduction in its diameter.

This concept has also been applied to chronic type IIIb dissections following surgery for type A dissection. However, tear-oriented surgery alone may not always be sufficient to induce positive aortic remodeling, as demonstrated in studies by Heo et al. [22,23]. These studies indicate that additional tears in the proximal DTA significantly affect aortic remodeling, even after addressing the primary entry tear. Although resolving the primary entry tear is crucial, residual re-entry tears in the proximal DTA or tears caused by the separation of intercostal artery ostia from the intima may still require further aortic interventions or operations over time.

The findings of Heo et al. [22,23] indicate that FET can positively influence aortic remodeling in type A dissections. By covering the primary tear in the arch as well as any additional tears in the pDTA, FET may reduce the necessity for further aortic operations or interventions in the future.

In summary, while tear-oriented surgery alone may be insufficient for optimal aortic remodeling, FET offers a valuable tool for achieving positive outcomes, particularly in cases where extensive pathology or additional tears are present in the arch and pDTA. This approach may ultimately reduce the likelihood of subsequent aortic procedures.

The FET procedure, which provides substantial benefits in treating extensive aortic pathology, is linked to certain complications that may lead to serious outcomes. Notably, distal stent graft-induced new entry (distal SINE) and spinal cord ischemia (SCI) are among the most critical complications associated with this technique.

Distal stent graft-induced new entry

Distal SINE is one of the primary complications that can occur after the FET procedure. The incidence of distal SINE reported in various studies ranges widely, from 0% to 27% [24]. This variation is primarily attributed to differences in measurement techniques across centers, including how the aortic diameter is measured—whether it is based on the long axis or the short axis, among other factors. Additionally, the design and characteristics of the FET devices themselves can influence the likelihood of developing distal SINE. For example, an in vitro study indicates that the E-vita device may significantly lower the risk of distal SINE compared to the Thoraflex device [25].

The primary cause of distal SINE is the radial force exerted by the stent graft within the FET device, with malalignment of the FET being another contributing factor. The consequences of distal SINE can be severe; if left untreated, mortality rates can reach as high as 25%, primarily due to the progression of dissection and eventual rupture. Consequently, secondary TEVAR interventions are often necessary to address distal SINE [26]. Reports on the E-vita OPEN NEO device indicate a very low incidence of distal SINE, such as 0.6% in 1-year outcomes, highlighting the importance of device selection in mitigating this complication [27].

Spinal cord ischemia

SCI is a severe complication linked to the FET technique, potentially resulting in substantial morbidity, such as paraplegia and other neurological deficits. The primary causes of SCI after FET include extensive aortic coverage and embolization.

While some studies suggest that the length of the FET device is a risk factor for SCI [28], it appears that the location of the FET’s distal landing zone is a more critical determinant. Research indicates that landing the distal end of the FET device at or above the T10 vertebral level is generally safer, as lower landing zones are associated with a higher risk of SCI [27,29,30]. Additionally, the presence of a “shaggy aorta”—a condition characterized by aortic atheroma—can increase the risk of SCI due to the potential for embolization [31].

In cases of acute type A dissection where the dissection extends medially and the intercostal arteries rely on the false lumen, the use of FET may increase the risk of SCI. Research conducted by Dong et al. [32] demonstrated that when the intercostal arteries between the T9 and L3 levels depend on the false lumen for blood supply, the incidence of SCI significantly increases during TARFET. Therefore, surgeons must carefully evaluate the viability of proceeding with TARFET in situations involving medial dissection in acute type A dissection.

For high-risk patients, the preemptive use of cerebrospinal fluid drainage (CSFd) is crucial. The severity of SCI can vary, and timely intervention is essential to prevent severe outcomes, such as loss of rectal tone. Aggressive management strategies, including CSFd, naloxone and steroids administration, and maintaining elevated blood pressure (up to 160 mm Hg), are critical in managing SCI [33]. The extent of SCI can lead to a range of complications, from respiratory muscle failure to immune dysfunction and infections resulting from pressure ulcers. Therefore, prompt and aggressive management, coupled with early rehabilitation, is essential for improving outcomes in patients who develop SCI following the FET procedure.

The sizing and planning of the FET procedure must be carefully tailored to the specific underlying pathology—acute aortic dissection (AAD), chronic aortic dissection (CAD), or thoracic aortic aneurysm (TAA). The purpose and urgency of the FET procedure significantly influence the decisions regarding sizing, which are crucial for the success of the surgery and the patient’s long-term outcomes (Fig. 1) [27].

Figure 1.Illustration of the E-vita OPEN NEO device as used in a repair of extensive aortic pathology. (A) In patients with acute aortic dissection (AAD), frozen elephant trunk (FET) aims to prevent proximal entry or re-entry tears. (B) In patients with chronic aortic dissection, FET aims not for a single-stage operation, but rather for functioning as a bridge to a second procedure. (C) In patients with thoracic aortic aneurysm, FET aims for complete sealing of the aneurysm in a single-stage operation, sometimes with additional thoracic endovascular aortic repair [27].

When sizing for AAD, it is crucial to avoid excessive oversizing due to the dissection’s characteristics [34]. In cases of AAD, the intimal flap is usually thin and fragile, which increases the risk of tearing if the stent graft is oversized. Therefore, sizing typically relies on the true longest diameter of the aorta, with 0% oversizing of the stent graft. This approach ensures that the stent graft fits securely without applying excessive radial force on the delicate intimal flap (Fig. 2) [35].

Figure 2.Stent graft diameter measurement in patients with acute aortic dissection [35].

For CAD, the indications for using FET are similar, primarily aimed at managing the entry tear or PAU located in the arch or pDTA. Due to the chronic nature of the dissection, the intimal flap becomes thicker and more stable, which permits more aggressive oversizing of the device. Typically, this involves sizing the FET device to about 110% of the aorta’s longest diameter. This strategy is designed to achieve a reliable seal and facilitate the expansion of the true lumen, while also minimizing the risk of distal SINE (Fig. 3) [35].

Figure 3.Stent graft diameter measurement in patients with acute aortic dissection [35].

In cases of TAA, the primary indication for FET procedure is the presence of aneurysmal changes in both the aortic arch and the pDTA. When the procedure is planned as a single-stage intervention, sizing is generally based on the diameter of the healthy aorta. The FET device is then selected to be approximately 110%–120% of this diameter (Fig. 4) [35].

Figure 4.Stent graft diameter measurement in patients with acute aortic dissection [35].

Proper sizing of the FET is crucial as it directly influences the success of the procedure and the long-term stability of the repair. Both oversizing and undersizing can result in complications such as distal SINE, graft migration, or inadequate sealing. Thus, meticulous measurement and consideration of the specific pathology are vital during the planning phase.

Decision for distal anastomosis

The selection of the distal anastomosis site varies depending on whether the patient is diagnosed with AAD, CAD, or TAA.

In AAD, the aortic diameter generally decreases as one moves distally. Therefore, extending the anastomosis too far distally can complicate the procedure, particularly with the formation of neo-media in mind. The objective is to strike a balance that ensures a secure anastomosis while avoiding undue narrowing of the aorta or damage to the delicate intimal flap.

In CAD, the distal anastomosis is typically performed proximal to the start of the type B dissection flap. The selection of the zone (1, 2, or 3) for the anastomosis is critical. Most surgeons favor zone 2 because zone 3 is often too deep, complicating the surgical procedure, whereas zone 1 may be too proximal, causing configuration problems with the FET device.

In TAA, the location of the distal anastomosis is typically determined by identifying where the healthy aorta begins, to ensure complete exclusion of the aneurysm. Similarly, in CAD, zone 2 is often the preferred site; however, careful planning is required to ensure that the distal end of the stent graft is positioned appropriately along the thoracic aorta.

Extent of aortic coverage

The extent of aortic coverage by the FET device is a critical factor, especially in relation to the risk of SCI. It is essential to carefully plan the distal landing zone of the stent graft to prevent excessive coverage of the descending thoracic aorta, which heightens the risk of SCI. Generally, covering the aorta down to the T10 vertebral level is considered safe based on experience; however, this must be assessed individually for each case [27].

The FET procedure, particularly when combined with TAR, is a complex and technically demanding operation. Simplifying the procedure is crucial for achieving better outcomes, especially in terms of reducing operative time, minimizing complications, and making the procedure more accessible to less experienced surgeons. This section outlines some of the key surgical techniques that can help streamline the FET procedure while maintaining high standards of patient care.

Right axillary artery cannulation and unilateral cerebral perfusion

One of the critical aspects of simplifying the FET procedure is the cannulation technique, especially in managing systemic circulation and cerebral perfusion. The decision to opt for either HAR or TAR often depends on weighing the simplicity and safety of the procedure against the long-term benefits of extensive aortic remodeling. HAR generally leads to shorter operations and fewer immediate complications, whereas TAR offers superior long-term outcomes in aortic remodeling.

To make TAR more accessible and manageable, right axillary artery cannulation is utilized. This technique simplifies the procedure by serving dual purposes: it acts as the cannulation site for systemic perfusion and provides access for cerebral perfusion. At our center, right axillary artery cannulation is the preferred method due to its ability to streamline the process. In certain instances, right innominate artery cannulation is also considered a feasible alternative. This approach not only facilitates cerebral perfusion but also eliminates the need for separate cerebral cannulation procedures, especially when unilateral cerebral perfusion is employed. Research, including studies conducted at our institution, indicates that there is no significant difference in outcomes between unilateral and bilateral cerebral perfusion, thus supporting the efficacy of this technique [36].

Extra-anatomic bypass of the left axillary artery to prevent spinal cord ischemia

If the patient is at high risk for SCI, we can also consider selective antegrade cerebral perfusion to all three supra-aortic branches to ensure comprehensive protection of both cerebral and spinal functions. Occasionally, the left vertebral artery is critical for preventing SCI, although accessing it can be challenging and may disrupt the surgical field for left subclavian artery (LSA) anastomosis. The Prince of Wales Hospital group recommends an extra-anatomic bypass to the left axillary artery, followed by perfusion of the LSA through the bypass graft [37,38].

Y-incision for head vessel exposure

A critical step in TAR, an essential component of the FET procedure, involves exposing the head vessels. Proper exposure is crucial for efficient and safe anastomosis, which can significantly impact the success of the surgery and reduce operative time. Given the complexity of TAR, it is important that the surgical approach is straightforward enough to be performed confidently by even less experienced surgeons.

At our center, we use a Y-incision technique beginning at the sternal notch to optimize exposure of the head vessels. This approach provides extensive exposure of the area surrounding the innominate vein, both superior and inferior to it. Following the Y-incision, the platysma muscle is removed to facilitate clear access to the underlying structures, and the fascia of the sternocleidomastoid (SCM) muscle is revealed as extensively as needed. Should the head vessels be notably displaced to the left or right, we may partially or completely remove the sternothyroid muscle to enhance access. We make every effort to preserve the SCM muscle, only excising a small portion in exceptional cases where it significantly impedes access.

Reinforcement suture for distal anastomosis

As the scope of surgery increases, so do the risks associated with extended hypothermic circulatory arrest, prolonged pump time, and subsequent coagulopathy, which can lead to significant bleeding. Therefore, effective suturing is crucial for preventing postoperative hemorrhage, especially at the distal anastomosis site (Fig. 5) [37].

Figure 5.Illustration and images of reinforcement suture technique at the distal anastomosis. (A) Reinforcement suturing over the continuous suture. (B) Completed reinforcement suture in all 360° of the collar. (C) Image of completed reinforcement sutures in the anterior portion. (D) Image of completed reinforcement sutures in the posterior portion. The asterisk (*) denotes the position of the plicated left subclavian artery os with zone 2 anastomosis [37].

At our center, we possess considerable expertise with the E-vita OPEN NEO device, which is widely utilized in Korea. Research indicates that the outcomes at the collar anastomosis site of the E-vita OPEN NEO device can vary based on the suture technique employed. Consequently, meticulous attention to the suture technique is crucial [39].

We employ a running suture technique for the initial anastomosis between the collar and distal aorta, followed by a reinforcement suture using a double-arm pledget suture that encircles the anastomosis site 360 degrees. This method has proven effective in reducing reoperation rates due to bleeding, as demonstrated in recent publications from our center [37].

BioGlue for neo-media formation and rapid hemostasis at suture sites

In the context of AAD, the dissection plane results in fragile and friable tissue. This necessitates the formation of a neo-media to reinforce the aortic wall and prevent bleeding. Although several techniques for neo-media formation are available, our center prefers using BioGlue because of its efficiency and rapid application [40].

BioGlue is particularly effective for quickly achieving hemostasis at the suture site and for preemptive priming on the fabric to prevent the oozing phenomenon [41]. This is crucial in complex and lengthy procedures such as FET. Although there are ongoing debates within the medical community about the potential risks of tissue necrosis and embolization associated with BioGlue, our experience indicates that when used properly, it significantly helps reduce bleeding and stabilize aortic tissue. This makes it an invaluable tool in our surgical arsenal, especially in high-risk cases where time is of the essence.

The success of the FET procedure, particularly when integrated with TAR, depends heavily on careful planning and precise execution of essential surgical techniques. Utilizing right axillary cannulation for both systemic perfusion and cerebral protection simplifies the surgical process. Additionally, the Y-incision offers optimal exposure for anastomosis of the head vessels. The application of reinforcement sutures and BioGlue is crucial for preventing postoperative complications, especially bleeding, and for achieving durable surgical results. By refining these techniques, the FET procedure can become more accessible and safer, even for surgeons with less experience, thereby improving patient outcomes.

The evolution of medical devices is crucial in the era of precision medicine, with the next-generation FET device, E-vita OPEN NEO, marking a significant advancement in this field [42,43]. The first-generation device, E-vita OPEN, featured improved graft porosity, while the second-generation device, E-vita OPEN plus, introduced a sewing cuff. In 2020, the E-vita OPEN NEO was launched, offering facilitated anastomosis in any arch zone and incorporating several innovative features designed to enhance surgical outcomes, especially in complex aortic procedures.

One of the key innovations of the E-vita OPEN NEO is its capability for wire-assisted landing of the FET device. This technique involves pre-positioning a guidewire in the arch and pDTA prior to surgery. During the operation, this guidewire is used to accurately guide the stent-graft to the designated location. This approach greatly increases the precision in positioning the distal part of the FET device, ensuring it aligns correctly within the planned zone and preventing malalignment.

Wire-assisted landing is especially advantageous in cases involving a shaggy aorta, where there is a significant risk of dislodging atheroma and triggering an embolic shower. By meticulously guiding the FET device along the wire, the disturbance of the atheroma is minimized, thus decreasing the likelihood of postoperative embolic events.

Prevention of distal stent graft-induced new entry

Distal SINE has been a significant concern with traditional FET devices. The E-vita OPEN NEO addresses this issue through an innovative design feature: the distal 2 springs of the stent-graft are positioned inside the graft material, rather than on the outside. This modification reduces the radial force at the distal end of the stent-graft, which is a primary cause of distal SINE (Fig. 6).

Figure 6.Two distal springs inside the graft to prevent distal stent graft-induced new entry (distal SINE). Ø, diameter; L, length; W, width.

Research conducted by Kim et al. [27] has shown that the E-vita OPEN NEO significantly reduced the incidence of distal SINE compared to previous devices. This decrease in distal SINE is especially critical as it lessens the necessity for secondary interventions like TEVAR and lowers the risk of complications associated with aortic rupture.

The E-vita OPEN NEO marks a significant advancement in the development of FET devices, incorporating features that tackle some of the most pressing challenges in complex aortic surgery. The wire-assisted landing technique improves the accuracy of stent-graft placement, while the innovative internal spring design reduces the risk of distal SINE. These enhancements position the E-vita OPEN NEO as an essential tool in the evolving field of precision aortic surgery, promising better outcomes for patients undergoing these intricate procedures.

As the concept of precision medicine gains traction, modern healthcare is increasingly adopting personalized treatment strategies. The cornerstone of precision medicine is the advancements in genetic analysis techniques, especially next-generation sequencing, which has initiated the era of big data in genomics. These advancements have led to the development of the N-of-1 treatment approach, where therapies are customized to the unique characteristics of each patient. However, while genetic data and big data analytics play a crucial role in precision medicine, confining the concept exclusively to these areas may be overly restrictive. Precision medicine, in a broader context, can and should be applied to additional fields, such as the treatment of aortic diseases and the surgical department.

The classification systems for aortic diseases have traditionally relied on models developed in the 1950s, such as the DeBakey and Stanford classifications. These systems have been beneficial to the medical community by providing simplified frameworks that facilitate rapid decision-making. However, there are ongoing efforts to refine these classifications due to their limitations in addressing the complexities of modern aortic disease management. One such effort is the TEM (Type-Entry-Malperfusion) classification system, which introduces a new approach to categorizing aortic conditions [44]. Additionally, devices like the AMDS Hybrid Prosthesis represent another effort to prevent distal anastomotic new entry tears following hemiarch replacement. This device is designed to stabilize and expand the true lumen and promote aortic remodeling in the arch [45,46].

The push towards new classification systems highlights the limitations of traditional classifications in the era of precision medicine. Although these older systems offer simplicity and facilitate quick clinical decision-making, they often do not adequately support the detailed, personalized treatment strategies required by precision medicine. For instance, considerations like the precise location of the entry tear, the degree and effects of malperfusion, and conditions that defy conventional categorization—such as non-A non-B dissections—necessitate more specific and tailored therapeutic strategies.

In this context, the FET procedure embodies surgical precision within the treatment of aortic diseases. Although it is not a universal remedy for all scenarios described in this broader vision of personalized care, FET marks a significant advancement in addressing complex aortic pathologies with heightened specificity. When incorporated into a detailed and personalized treatment plan, the FET technique provides a surgical solution that aligns with the goals of precision medicine—namely, targeting the specific anatomical and pathological features of aortic disease in a way that traditional, one-size-fits-all approaches cannot.

In summary, as we transition beyond the era of precision medicine, the field of aortic surgery is set to fully embrace these advanced concepts. This will likely entail the ongoing evolution of classification systems, the refinement of surgical techniques such as FET, and the incorporation of genetic and big data insights to enhance patient-specific outcomes. Consequently, the future of aortic disease management hinges on our capacity to apply these broad principles of precision medicine to the unique challenges posed by complex vascular conditions.

Authors contributions

Conceptualization: SWS, HL. Data curation: HL, MSK. Formal analysis: SWS, HL. Methodology: HL. Project administration: SWS, RHLW, JYKH, WYS, HJ. Visualization: SWS, HL. Writing–original draft: HL. Writing–review & editing: SWS, RHLW, JYKH, WYS, HJ. Final approval of the manuscript: all authors.

Conflict of interest

Suk-Won Song is an associate editor of the Journal of Chest Surgery but was not involved in the peer reviewer selection, evaluation, or decision process of this article. Except for that, no other potential conflict of interest relevant to this article was reported.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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  29. Wang C, Zhang W, Peng J, et al. Outcomes of long versus short stent Cronus hybrid prosthesis in type A aortic dissection: a single centre experience. J Card Surg 2021;36:3261-8. https://doi.org/10.1111/jocs.15766.
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Article

Review

J Chest Surg 2024; 57(5): 419-429

Published online September 5, 2024 https://doi.org/10.5090/jcs.24.089

Copyright © Journal of Chest Surgery.

Next-Generation Frozen Elephant Trunk Technique in the Era of Precision Medicine

Suk-Won Song , M.D., Ph.D.1,*, Ha Lee , M.D.1,*, Myeong Su Kim , M.D.1, Randolph Hung Leung Wong , F.R.C.S.2, Jacky Yan Kit Ho , F.R.C.S.2, Wilson Y. Szeto, M.D.3, Heinz Jakob , M.D.4,†

1Department of Thoracic and Cardiovascular Surgery, Ewha Womans University Aorta and Vascular Hospital, Ewha Womans University Medical Center, Seoul, Korea; 2Division of Cardiothoracic Surgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China; 3Division of Cardiovascular Surgery, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 4Department of Cardiothoracic Surgery, West German Heart and Vascular Center, University Hospital Essen, Essen, Germany

Correspondence to:Suk-Won Song
Tel 82-2-6986-2110
Fax 82-2-6986-2111
E-mail stevensong@ewha.ac.kr
ORCID
https://orcid.org/0000-0002-9850-9707

*These authors contributed equally to this work as the first authors.
Current affiliation: Diagnosticum Mülheim, Mülheim, Germany

Received: August 23, 2024; Accepted: August 28, 2024

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The frozen elephant trunk (FET) technique can be applied to extensive aortic pathology, including lesions in the aortic arch and proximal descending thoracic aorta. FET is useful for tear-oriented surgery in dissections, managing malperfusion syndrome, and promoting positive aortic remodeling. Despite these benefits, complications such as distal stent-induced new entry and spinal cord ischemia can pose serious problems with the FET technique. To prevent these complications, careful sizing and planning of the FET are crucial. Additionally, since the FET technique involves total arch replacement, meticulous surgical skills are essential, particularly for young surgeons. In this article, we propose several techniques to simplify surgical procedures, which may lead to better outcomes for patients with extensive aortic pathology. In the era of precision medicine, the next-generation FET device could facilitate the treatment of complex aortic diseases through a patient-tailored approach.

Keywords: Aortic diseases, Vascular grafting, Endovascular aneurysm repair, Endoleak, Spinal cord ischemia

Introduction

Aortic diseases encompass a broad spectrum of disorders that affect a wide anatomical range, from the aortic valve to the abdominal aorta. Additionally, these conditions vary in their urgency, ranging from acute aortic syndromes, such as aortic dissection [1,2], to chronic conditions such as aortic aneurysms [3,4]. The pathophysiology of aortic diseases is equally diverse, including genetically driven conditions such as Marfan syndrome [5] and lifestyle-influenced disorders such as atherosclerosis. Additionally, aortic inflammation can result from bacterial infections or autoimmune diseases [6,7]. Given the aorta’s critical role in supplying blood to all organs, these conditions can lead to a wide array of symptoms and complications, including cerebral infarctions and lower limb ischemia [8]. Historically and in the present day, managing such a diverse and extensive range of aortic diseases has been challenging.

Among the most challenging areas in medical treatment are those involving extensive aortic pathology [9]. While localized aortic diseases can be managed more easily, the complexity of treatment increases significantly when the pathology extends over a larger anatomical area, requiring careful consideration of potential complications. The challenge of treating extensive aortic pathology has persisted, prompting ongoing exploration of surgical solutions. A significant advancement occurred in 1983 when Hans Georg Borst from the Hannover group in Germany developed the elephant trunk (ET) technique, initially used to address extensive aortic pathology. However, a major limitation of this technique was the requirement to perform the surgery in 2 stages [10].

The introduction of stent implantation in aortic diseases in 1994 marked a new era [11]. In 2003, the first attempt was made to integrate the ET technique with endovascular intervention [12]. This innovation was developed by the Hannover group, led by Hans Georg Borst, the pioneer of the ET technique. He performed the procedure under hypothermic circulatory arrest, incorporating endovascular techniques. The added rigidity from the stent led Borst to name this new method “frozen ET” (FET), inspired by the stent’s frozen appearance on imaging. The concept of FET took an additional 20 years to fully evolve, culminating in the integration of stent implantation.

This review article aims to discuss recent developments in FET, marking 40 years since the introduction of ET and 20 years since FET was first implemented. It covers indications, complications, preparation protocols, surgical tips, features of next-generation FET products, and the role of FET in the era of precision medicine. Additionally, the article will examine the characteristics of the Evita OPEN NEO, which has been available in Korea since April 2021.

Indications for frozen elephant trunk

It is useful to categorize the indications for the FET procedure based on the primary objectives of the treatment. There are 4 main purposes for which FET is performed: (1) addressing extensive aortic pathology, (2) implementing a tear-oriented surgical approach, (3) managing malperfusion syndrome, and (4) promoting aortic remodeling.

Frozen elephant trunk for extensive aortic pathology

Currently, there is no universally accepted definition of “extensive aortic pathology.” This ambiguity has resulted in the use of various terms in the literature, such as “complex aortic pathology [13,14].” To better understand the indications for FET in the context of extensive aortic pathology, it is essential to define the condition clearly to determine when FET should be applied.

For FET to be indicated, the aortic lesion must involve a specific anatomical region: the pathology must extend from the aortic arch to the proximal descending thoracic aorta (pDTA). This means that FET is appropriate for conditions such as an aneurysm, a primary entry tear causing dissection, a penetrating atherosclerotic ulcer (PAU), or a rupture point within this range.

The anatomical characteristics of such lesions present challenges for traditional surgical approaches such as median sternotomy or left thoracotomy, particularly when the pathology spans a broad area. While FET alone may not resolve all issues, it can facilitate subsequent operations or interventions. Although alternative surgical approaches, such as the clamshell incision or newer techniques, such as anterolateral thoracotomy with partial sternotomy, have been proposed, they have not gained widespread acceptance [15]. Therefore, FET is typically indicated for diseases involving the aortic arch and pDTA, and may also be considered when the pathology extends to the distal part of the pDTA. In situations where the lesion is confined to the proximal part of the arch and the pDTA, FET may be sufficient. However, if the distal pDTA is affected, additional thoracic endovascular aortic repair (TEVAR) or a second-stage operation may be necessary.

Frozen elephant trunk for a tear-oriented approach

Another critical objective of FET is the tear-oriented approach. The 2021 American Association for Thoracic Surgery expert consensus for the surgical treatment of acute type A aortic dissection recommends a tear-oriented approach and says that extended aortic arch replacement is reasonable when the primary entry tear is located in the arch or pDTA [16]. While the surgeon’s society recommends a tear-oriented approach explicitly, the 2022 American College of Cardiology/American Heart Association guidelines do not explicitly address tear-oriented surgery in acute type A aortic dissection, but they do indirectly suggest this approach [17]. Initially, the guidelines recommend opening the distal end of the dissection to directly visualize the tear. This suggests that adopting a tear-oriented approach in cases of acute type A aortic dissection is impractical if the tear is located on the lesser curvature. Furthermore, the guidelines indicate that if the entry tear is not located in the arch or pDTA, a hemiarch repair (HAR) may be sufficient. This approach minimizes the extent of surgery, thereby reducing postoperative complications and mortality. However, if the tear is situated in the arch or pDTA, the surgical scope must be expanded to include total arch replacement (TAR). This expansion increases both the operative time and the risk of complications, whereas HAR would leave the tear unresolved.

In such dilemmas, FET offers a practical solution by effectively covering the entry tear with a stent-graft. FET is especially beneficial in acute type B dissections that are complex and not amenable to TEVAR, as well as in non-A non-B dissections where the primary entry tear occurs at the pDTA. This approach is also applicable in instances of PAU or aneurysm rupture at the pDTA.

Frozen elephant trunk for malperfusion syndrome

Malperfusion syndrome occurs when organs and tissues receive insufficient blood flow, resulting in ischemia and the potential for organ dysfunction or failure. This condition is linked to high morbidity and mortality rates in both acute type A and type B aortic dissections. FET has emerged as an innovative treatment option for malperfusion syndrome, as it promotes the expansion of the true lumen and covers the primary entry tear in the arch or proximal DTA.

Yang et al. [18] recommend an “intervention-first” approach for some type A dissection cases, a strategy that is also supported by recent guidelines when there is malperfusion of the celiac artery or superior mesenteric artery. However, this approach may not be feasible when there is a collapse of the true lumen at the DTA level without a re-entry tear. In such scenarios, the intervention might require creating a fenestration in the flap to decrease false lumen pressure and restore true lumen pressure, although this procedure carries a risk of rupture [19]. Therefore, TAR with FET (TARFET) may be necessary to address malperfusion syndrome by covering the primary entry tear.

Frozen elephant trunk for aortic remodeling

The concept of aortic remodeling gained prominence in the late 2000s, especially in the context of acute type B dissections. This interest largely stemmed from observations of changes in the diameters of the true and false lumens following TEVAR [20]. Research into aortic remodeling after TARFET was initiated by studies such as the one conducted by Iafrancesco et al. [21]. Aortic remodeling can be categorized into 3 types: (1) positive, (2) negative, or (3) stable. Positive aortic remodeling is characterized by the expansion of the true lumen and the formation of thrombus in the false lumen, which leads to a reduction in its diameter.

This concept has also been applied to chronic type IIIb dissections following surgery for type A dissection. However, tear-oriented surgery alone may not always be sufficient to induce positive aortic remodeling, as demonstrated in studies by Heo et al. [22,23]. These studies indicate that additional tears in the proximal DTA significantly affect aortic remodeling, even after addressing the primary entry tear. Although resolving the primary entry tear is crucial, residual re-entry tears in the proximal DTA or tears caused by the separation of intercostal artery ostia from the intima may still require further aortic interventions or operations over time.

The findings of Heo et al. [22,23] indicate that FET can positively influence aortic remodeling in type A dissections. By covering the primary tear in the arch as well as any additional tears in the pDTA, FET may reduce the necessity for further aortic operations or interventions in the future.

In summary, while tear-oriented surgery alone may be insufficient for optimal aortic remodeling, FET offers a valuable tool for achieving positive outcomes, particularly in cases where extensive pathology or additional tears are present in the arch and pDTA. This approach may ultimately reduce the likelihood of subsequent aortic procedures.

Complications of frozen elephant trunk

The FET procedure, which provides substantial benefits in treating extensive aortic pathology, is linked to certain complications that may lead to serious outcomes. Notably, distal stent graft-induced new entry (distal SINE) and spinal cord ischemia (SCI) are among the most critical complications associated with this technique.

Distal stent graft-induced new entry

Distal SINE is one of the primary complications that can occur after the FET procedure. The incidence of distal SINE reported in various studies ranges widely, from 0% to 27% [24]. This variation is primarily attributed to differences in measurement techniques across centers, including how the aortic diameter is measured—whether it is based on the long axis or the short axis, among other factors. Additionally, the design and characteristics of the FET devices themselves can influence the likelihood of developing distal SINE. For example, an in vitro study indicates that the E-vita device may significantly lower the risk of distal SINE compared to the Thoraflex device [25].

The primary cause of distal SINE is the radial force exerted by the stent graft within the FET device, with malalignment of the FET being another contributing factor. The consequences of distal SINE can be severe; if left untreated, mortality rates can reach as high as 25%, primarily due to the progression of dissection and eventual rupture. Consequently, secondary TEVAR interventions are often necessary to address distal SINE [26]. Reports on the E-vita OPEN NEO device indicate a very low incidence of distal SINE, such as 0.6% in 1-year outcomes, highlighting the importance of device selection in mitigating this complication [27].

Spinal cord ischemia

SCI is a severe complication linked to the FET technique, potentially resulting in substantial morbidity, such as paraplegia and other neurological deficits. The primary causes of SCI after FET include extensive aortic coverage and embolization.

While some studies suggest that the length of the FET device is a risk factor for SCI [28], it appears that the location of the FET’s distal landing zone is a more critical determinant. Research indicates that landing the distal end of the FET device at or above the T10 vertebral level is generally safer, as lower landing zones are associated with a higher risk of SCI [27,29,30]. Additionally, the presence of a “shaggy aorta”—a condition characterized by aortic atheroma—can increase the risk of SCI due to the potential for embolization [31].

In cases of acute type A dissection where the dissection extends medially and the intercostal arteries rely on the false lumen, the use of FET may increase the risk of SCI. Research conducted by Dong et al. [32] demonstrated that when the intercostal arteries between the T9 and L3 levels depend on the false lumen for blood supply, the incidence of SCI significantly increases during TARFET. Therefore, surgeons must carefully evaluate the viability of proceeding with TARFET in situations involving medial dissection in acute type A dissection.

For high-risk patients, the preemptive use of cerebrospinal fluid drainage (CSFd) is crucial. The severity of SCI can vary, and timely intervention is essential to prevent severe outcomes, such as loss of rectal tone. Aggressive management strategies, including CSFd, naloxone and steroids administration, and maintaining elevated blood pressure (up to 160 mm Hg), are critical in managing SCI [33]. The extent of SCI can lead to a range of complications, from respiratory muscle failure to immune dysfunction and infections resulting from pressure ulcers. Therefore, prompt and aggressive management, coupled with early rehabilitation, is essential for improving outcomes in patients who develop SCI following the FET procedure.

Sizing and planning for frozen elephant trunk

The sizing and planning of the FET procedure must be carefully tailored to the specific underlying pathology—acute aortic dissection (AAD), chronic aortic dissection (CAD), or thoracic aortic aneurysm (TAA). The purpose and urgency of the FET procedure significantly influence the decisions regarding sizing, which are crucial for the success of the surgery and the patient’s long-term outcomes (Fig. 1) [27].

Figure 1. Illustration of the E-vita OPEN NEO device as used in a repair of extensive aortic pathology. (A) In patients with acute aortic dissection (AAD), frozen elephant trunk (FET) aims to prevent proximal entry or re-entry tears. (B) In patients with chronic aortic dissection, FET aims not for a single-stage operation, but rather for functioning as a bridge to a second procedure. (C) In patients with thoracic aortic aneurysm, FET aims for complete sealing of the aneurysm in a single-stage operation, sometimes with additional thoracic endovascular aortic repair [27].

When sizing for AAD, it is crucial to avoid excessive oversizing due to the dissection’s characteristics [34]. In cases of AAD, the intimal flap is usually thin and fragile, which increases the risk of tearing if the stent graft is oversized. Therefore, sizing typically relies on the true longest diameter of the aorta, with 0% oversizing of the stent graft. This approach ensures that the stent graft fits securely without applying excessive radial force on the delicate intimal flap (Fig. 2) [35].

Figure 2. Stent graft diameter measurement in patients with acute aortic dissection [35].

For CAD, the indications for using FET are similar, primarily aimed at managing the entry tear or PAU located in the arch or pDTA. Due to the chronic nature of the dissection, the intimal flap becomes thicker and more stable, which permits more aggressive oversizing of the device. Typically, this involves sizing the FET device to about 110% of the aorta’s longest diameter. This strategy is designed to achieve a reliable seal and facilitate the expansion of the true lumen, while also minimizing the risk of distal SINE (Fig. 3) [35].

Figure 3. Stent graft diameter measurement in patients with acute aortic dissection [35].

In cases of TAA, the primary indication for FET procedure is the presence of aneurysmal changes in both the aortic arch and the pDTA. When the procedure is planned as a single-stage intervention, sizing is generally based on the diameter of the healthy aorta. The FET device is then selected to be approximately 110%–120% of this diameter (Fig. 4) [35].

Figure 4. Stent graft diameter measurement in patients with acute aortic dissection [35].

Proper sizing of the FET is crucial as it directly influences the success of the procedure and the long-term stability of the repair. Both oversizing and undersizing can result in complications such as distal SINE, graft migration, or inadequate sealing. Thus, meticulous measurement and consideration of the specific pathology are vital during the planning phase.

Decision for distal anastomosis

The selection of the distal anastomosis site varies depending on whether the patient is diagnosed with AAD, CAD, or TAA.

In AAD, the aortic diameter generally decreases as one moves distally. Therefore, extending the anastomosis too far distally can complicate the procedure, particularly with the formation of neo-media in mind. The objective is to strike a balance that ensures a secure anastomosis while avoiding undue narrowing of the aorta or damage to the delicate intimal flap.

In CAD, the distal anastomosis is typically performed proximal to the start of the type B dissection flap. The selection of the zone (1, 2, or 3) for the anastomosis is critical. Most surgeons favor zone 2 because zone 3 is often too deep, complicating the surgical procedure, whereas zone 1 may be too proximal, causing configuration problems with the FET device.

In TAA, the location of the distal anastomosis is typically determined by identifying where the healthy aorta begins, to ensure complete exclusion of the aneurysm. Similarly, in CAD, zone 2 is often the preferred site; however, careful planning is required to ensure that the distal end of the stent graft is positioned appropriately along the thoracic aorta.

Extent of aortic coverage

The extent of aortic coverage by the FET device is a critical factor, especially in relation to the risk of SCI. It is essential to carefully plan the distal landing zone of the stent graft to prevent excessive coverage of the descending thoracic aorta, which heightens the risk of SCI. Generally, covering the aorta down to the T10 vertebral level is considered safe based on experience; however, this must be assessed individually for each case [27].

Surgical techniques for frozen elephant trunk

The FET procedure, particularly when combined with TAR, is a complex and technically demanding operation. Simplifying the procedure is crucial for achieving better outcomes, especially in terms of reducing operative time, minimizing complications, and making the procedure more accessible to less experienced surgeons. This section outlines some of the key surgical techniques that can help streamline the FET procedure while maintaining high standards of patient care.

Right axillary artery cannulation and unilateral cerebral perfusion

One of the critical aspects of simplifying the FET procedure is the cannulation technique, especially in managing systemic circulation and cerebral perfusion. The decision to opt for either HAR or TAR often depends on weighing the simplicity and safety of the procedure against the long-term benefits of extensive aortic remodeling. HAR generally leads to shorter operations and fewer immediate complications, whereas TAR offers superior long-term outcomes in aortic remodeling.

To make TAR more accessible and manageable, right axillary artery cannulation is utilized. This technique simplifies the procedure by serving dual purposes: it acts as the cannulation site for systemic perfusion and provides access for cerebral perfusion. At our center, right axillary artery cannulation is the preferred method due to its ability to streamline the process. In certain instances, right innominate artery cannulation is also considered a feasible alternative. This approach not only facilitates cerebral perfusion but also eliminates the need for separate cerebral cannulation procedures, especially when unilateral cerebral perfusion is employed. Research, including studies conducted at our institution, indicates that there is no significant difference in outcomes between unilateral and bilateral cerebral perfusion, thus supporting the efficacy of this technique [36].

Extra-anatomic bypass of the left axillary artery to prevent spinal cord ischemia

If the patient is at high risk for SCI, we can also consider selective antegrade cerebral perfusion to all three supra-aortic branches to ensure comprehensive protection of both cerebral and spinal functions. Occasionally, the left vertebral artery is critical for preventing SCI, although accessing it can be challenging and may disrupt the surgical field for left subclavian artery (LSA) anastomosis. The Prince of Wales Hospital group recommends an extra-anatomic bypass to the left axillary artery, followed by perfusion of the LSA through the bypass graft [37,38].

Y-incision for head vessel exposure

A critical step in TAR, an essential component of the FET procedure, involves exposing the head vessels. Proper exposure is crucial for efficient and safe anastomosis, which can significantly impact the success of the surgery and reduce operative time. Given the complexity of TAR, it is important that the surgical approach is straightforward enough to be performed confidently by even less experienced surgeons.

At our center, we use a Y-incision technique beginning at the sternal notch to optimize exposure of the head vessels. This approach provides extensive exposure of the area surrounding the innominate vein, both superior and inferior to it. Following the Y-incision, the platysma muscle is removed to facilitate clear access to the underlying structures, and the fascia of the sternocleidomastoid (SCM) muscle is revealed as extensively as needed. Should the head vessels be notably displaced to the left or right, we may partially or completely remove the sternothyroid muscle to enhance access. We make every effort to preserve the SCM muscle, only excising a small portion in exceptional cases where it significantly impedes access.

Reinforcement suture for distal anastomosis

As the scope of surgery increases, so do the risks associated with extended hypothermic circulatory arrest, prolonged pump time, and subsequent coagulopathy, which can lead to significant bleeding. Therefore, effective suturing is crucial for preventing postoperative hemorrhage, especially at the distal anastomosis site (Fig. 5) [37].

Figure 5. Illustration and images of reinforcement suture technique at the distal anastomosis. (A) Reinforcement suturing over the continuous suture. (B) Completed reinforcement suture in all 360° of the collar. (C) Image of completed reinforcement sutures in the anterior portion. (D) Image of completed reinforcement sutures in the posterior portion. The asterisk (*) denotes the position of the plicated left subclavian artery os with zone 2 anastomosis [37].

At our center, we possess considerable expertise with the E-vita OPEN NEO device, which is widely utilized in Korea. Research indicates that the outcomes at the collar anastomosis site of the E-vita OPEN NEO device can vary based on the suture technique employed. Consequently, meticulous attention to the suture technique is crucial [39].

We employ a running suture technique for the initial anastomosis between the collar and distal aorta, followed by a reinforcement suture using a double-arm pledget suture that encircles the anastomosis site 360 degrees. This method has proven effective in reducing reoperation rates due to bleeding, as demonstrated in recent publications from our center [37].

BioGlue for neo-media formation and rapid hemostasis at suture sites

In the context of AAD, the dissection plane results in fragile and friable tissue. This necessitates the formation of a neo-media to reinforce the aortic wall and prevent bleeding. Although several techniques for neo-media formation are available, our center prefers using BioGlue because of its efficiency and rapid application [40].

BioGlue is particularly effective for quickly achieving hemostasis at the suture site and for preemptive priming on the fabric to prevent the oozing phenomenon [41]. This is crucial in complex and lengthy procedures such as FET. Although there are ongoing debates within the medical community about the potential risks of tissue necrosis and embolization associated with BioGlue, our experience indicates that when used properly, it significantly helps reduce bleeding and stabilize aortic tissue. This makes it an invaluable tool in our surgical arsenal, especially in high-risk cases where time is of the essence.

The success of the FET procedure, particularly when integrated with TAR, depends heavily on careful planning and precise execution of essential surgical techniques. Utilizing right axillary cannulation for both systemic perfusion and cerebral protection simplifies the surgical process. Additionally, the Y-incision offers optimal exposure for anastomosis of the head vessels. The application of reinforcement sutures and BioGlue is crucial for preventing postoperative complications, especially bleeding, and for achieving durable surgical results. By refining these techniques, the FET procedure can become more accessible and safer, even for surgeons with less experience, thereby improving patient outcomes.

Next-generation frozen elephant trunk device: E-vita OPEN NEO

The evolution of medical devices is crucial in the era of precision medicine, with the next-generation FET device, E-vita OPEN NEO, marking a significant advancement in this field [42,43]. The first-generation device, E-vita OPEN, featured improved graft porosity, while the second-generation device, E-vita OPEN plus, introduced a sewing cuff. In 2020, the E-vita OPEN NEO was launched, offering facilitated anastomosis in any arch zone and incorporating several innovative features designed to enhance surgical outcomes, especially in complex aortic procedures.

Wire-assisted landing of frozen elephant trunk

One of the key innovations of the E-vita OPEN NEO is its capability for wire-assisted landing of the FET device. This technique involves pre-positioning a guidewire in the arch and pDTA prior to surgery. During the operation, this guidewire is used to accurately guide the stent-graft to the designated location. This approach greatly increases the precision in positioning the distal part of the FET device, ensuring it aligns correctly within the planned zone and preventing malalignment.

Wire-assisted landing is especially advantageous in cases involving a shaggy aorta, where there is a significant risk of dislodging atheroma and triggering an embolic shower. By meticulously guiding the FET device along the wire, the disturbance of the atheroma is minimized, thus decreasing the likelihood of postoperative embolic events.

Prevention of distal stent graft-induced new entry

Distal SINE has been a significant concern with traditional FET devices. The E-vita OPEN NEO addresses this issue through an innovative design feature: the distal 2 springs of the stent-graft are positioned inside the graft material, rather than on the outside. This modification reduces the radial force at the distal end of the stent-graft, which is a primary cause of distal SINE (Fig. 6).

Figure 6. Two distal springs inside the graft to prevent distal stent graft-induced new entry (distal SINE). Ø, diameter; L, length; W, width.

Research conducted by Kim et al. [27] has shown that the E-vita OPEN NEO significantly reduced the incidence of distal SINE compared to previous devices. This decrease in distal SINE is especially critical as it lessens the necessity for secondary interventions like TEVAR and lowers the risk of complications associated with aortic rupture.

The E-vita OPEN NEO marks a significant advancement in the development of FET devices, incorporating features that tackle some of the most pressing challenges in complex aortic surgery. The wire-assisted landing technique improves the accuracy of stent-graft placement, while the innovative internal spring design reduces the risk of distal SINE. These enhancements position the E-vita OPEN NEO as an essential tool in the evolving field of precision aortic surgery, promising better outcomes for patients undergoing these intricate procedures.

In the era of precision medicine

As the concept of precision medicine gains traction, modern healthcare is increasingly adopting personalized treatment strategies. The cornerstone of precision medicine is the advancements in genetic analysis techniques, especially next-generation sequencing, which has initiated the era of big data in genomics. These advancements have led to the development of the N-of-1 treatment approach, where therapies are customized to the unique characteristics of each patient. However, while genetic data and big data analytics play a crucial role in precision medicine, confining the concept exclusively to these areas may be overly restrictive. Precision medicine, in a broader context, can and should be applied to additional fields, such as the treatment of aortic diseases and the surgical department.

The classification systems for aortic diseases have traditionally relied on models developed in the 1950s, such as the DeBakey and Stanford classifications. These systems have been beneficial to the medical community by providing simplified frameworks that facilitate rapid decision-making. However, there are ongoing efforts to refine these classifications due to their limitations in addressing the complexities of modern aortic disease management. One such effort is the TEM (Type-Entry-Malperfusion) classification system, which introduces a new approach to categorizing aortic conditions [44]. Additionally, devices like the AMDS Hybrid Prosthesis represent another effort to prevent distal anastomotic new entry tears following hemiarch replacement. This device is designed to stabilize and expand the true lumen and promote aortic remodeling in the arch [45,46].

The push towards new classification systems highlights the limitations of traditional classifications in the era of precision medicine. Although these older systems offer simplicity and facilitate quick clinical decision-making, they often do not adequately support the detailed, personalized treatment strategies required by precision medicine. For instance, considerations like the precise location of the entry tear, the degree and effects of malperfusion, and conditions that defy conventional categorization—such as non-A non-B dissections—necessitate more specific and tailored therapeutic strategies.

In this context, the FET procedure embodies surgical precision within the treatment of aortic diseases. Although it is not a universal remedy for all scenarios described in this broader vision of personalized care, FET marks a significant advancement in addressing complex aortic pathologies with heightened specificity. When incorporated into a detailed and personalized treatment plan, the FET technique provides a surgical solution that aligns with the goals of precision medicine—namely, targeting the specific anatomical and pathological features of aortic disease in a way that traditional, one-size-fits-all approaches cannot.

Conclusion

In summary, as we transition beyond the era of precision medicine, the field of aortic surgery is set to fully embrace these advanced concepts. This will likely entail the ongoing evolution of classification systems, the refinement of surgical techniques such as FET, and the incorporation of genetic and big data insights to enhance patient-specific outcomes. Consequently, the future of aortic disease management hinges on our capacity to apply these broad principles of precision medicine to the unique challenges posed by complex vascular conditions.

Article information

Authors contributions

Conceptualization: SWS, HL. Data curation: HL, MSK. Formal analysis: SWS, HL. Methodology: HL. Project administration: SWS, RHLW, JYKH, WYS, HJ. Visualization: SWS, HL. Writing–original draft: HL. Writing–review & editing: SWS, RHLW, JYKH, WYS, HJ. Final approval of the manuscript: all authors.

Conflict of interest

Suk-Won Song is an associate editor of the Journal of Chest Surgery but was not involved in the peer reviewer selection, evaluation, or decision process of this article. Except for that, no other potential conflict of interest relevant to this article was reported.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Fig 1.

Figure 1.Illustration of the E-vita OPEN NEO device as used in a repair of extensive aortic pathology. (A) In patients with acute aortic dissection (AAD), frozen elephant trunk (FET) aims to prevent proximal entry or re-entry tears. (B) In patients with chronic aortic dissection, FET aims not for a single-stage operation, but rather for functioning as a bridge to a second procedure. (C) In patients with thoracic aortic aneurysm, FET aims for complete sealing of the aneurysm in a single-stage operation, sometimes with additional thoracic endovascular aortic repair [27].
Journal of Chest Surgery 2024; 57: 419-429https://doi.org/10.5090/jcs.24.089

Fig 2.

Figure 2.Stent graft diameter measurement in patients with acute aortic dissection [35].
Journal of Chest Surgery 2024; 57: 419-429https://doi.org/10.5090/jcs.24.089

Fig 3.

Figure 3.Stent graft diameter measurement in patients with acute aortic dissection [35].
Journal of Chest Surgery 2024; 57: 419-429https://doi.org/10.5090/jcs.24.089

Fig 4.

Figure 4.Stent graft diameter measurement in patients with acute aortic dissection [35].
Journal of Chest Surgery 2024; 57: 419-429https://doi.org/10.5090/jcs.24.089

Fig 5.

Figure 5.Illustration and images of reinforcement suture technique at the distal anastomosis. (A) Reinforcement suturing over the continuous suture. (B) Completed reinforcement suture in all 360° of the collar. (C) Image of completed reinforcement sutures in the anterior portion. (D) Image of completed reinforcement sutures in the posterior portion. The asterisk (*) denotes the position of the plicated left subclavian artery os with zone 2 anastomosis [37].
Journal of Chest Surgery 2024; 57: 419-429https://doi.org/10.5090/jcs.24.089

Fig 6.

Figure 6.Two distal springs inside the graft to prevent distal stent graft-induced new entry (distal SINE). Ø, diameter; L, length; W, width.
Journal of Chest Surgery 2024; 57: 419-429https://doi.org/10.5090/jcs.24.089

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