Endoscopic vacuum-assisted closure as a first-line treatment for post-esophagectomy anastomotic leaks: A paradigm shift in management

Abstract

Post-esophagectomy anastomotic leak (AL) is a severe complication following esophagectomy, contributing to increased morbidity, prolonged hospitalization, and a significant risk of mortality. Endoscopic vacuum-assisted closure (EndoVac) has emerged as a promising first-line treatment, offering a highly effective approach for managing post-esophagectomy AL. EndoVac therapy utilizes continuous negative pressure within the esophageal lumen or mediastinal cavity, promoting granulation tissue formation, accelerating wound healing, and enhancing AL closure rates. Compared to stenting, EndoVac provides distinct advantages, including superior adaptability to varying leak sizes and locations, enhanced secretion drainage, and lower rates of reintervention. Clinical studies have demonstrated higher success rates, decreased post-intervention complications, and shorter hospital stays. Despite its advantages, challenges persist in patient selection, procedural expertise, and accessibility. EndoVac application requires experienced endoscopic teams and multidisciplinary expertise, which is best achieved in high-volume centers with specialized care. Variability in EndoVac protocols necessitate further refinement and standardization to optimize treatment outcomes. The integration of EndoVac into standardized treatment guidelines holds promise for improving patient outcomes and redefining the management approach for this challenging postoperative complication.

Key Words: Esophageal cancer; Esophagectomy; Anastomotic leak; Endoscopic vacuum-assisted closure; Endoscopic vacuum therapy

Core Tip: Post-esophagectomy anastomotic leak is a severe complication with increased morbidity and high risk of mortality. Endoscopic vacuum-assisted closure has emerged as an effective first-line treatment for managing this condition. The therapy applies continuous negative pressure to promote granulation tissue and accelerate healing. When compared to stenting, endoscopic vacuum-assisted closure has superior adaptability, enhanced drainage, and lower reintervention rates. Clinical studies confirm higher success rates and shorter hospital stays. However, the procedure requires experienced, multidisciplinary teams, and protocols need further standardization to optimize outcomes.

INTRODUCTION

Anastomotic leak (AL) is a serious postoperative complication following esophagectomy and is associated with severe consequences, including prolonged hospitalization, repeated interventions, and even increased mortality rates[1-3]. The Esophageal Complication Consensus Group defined AL as a full-thickness defect involving the esophagus, the anastomosis[4], the staple line, or the conduit irrespective of presentation or method of identification. They descripted 3 types of AL, type I which can be managed conservatively with nil per os, broad spectrum antibiotics, antifungals and close monitoring, and type II and type III ALs which require interventional or surgical management respectively[4]. Despite advancements in surgical techniques, the occurrence of AL remains a major concern, as it can complicate recovery and diminish the overall quality of care for patients. The Oesophago-Gastric Anastomosis Study Group reported an overall incidence of 14.2% following esophagectomy[1], but individual studies reported incidences from 3% to 30%[5]. Factors influencing the risk of AL include patient-related characteristics such as older age, sex, comorbidities, and the technical aspects of the surgery itself, including the duration of the procedure and the operator’s experience[3,6,7]. Neoadjuvant therapy, chemotherapy or chemoradiotherapy, is linked to an increased risk of AL.

The management of AL has evolved, with various treatment strategies being explored, including endoscopic options such as endoclips, tissue sealants, suturing systems, and notably, endoscopic vacuum therapy or endoscopic vacuum-assisted closure (EndoVAC)[2,8]. EndoVAC has shown promise as a first-line treatment for AL post-esophagectomy, with a focus on enhancing the healing process and minimizing adverse outcomes associated with AL[2]. This shift towards utilizing EndoVAC reflects an ongoing effort to improve management practices and patient care in the face of this challenging complication.

ENDOVAC TECHNOLOGY AND MECHANISM OF ACTION

EndoVAC technology employs negative pressure wound therapy to enhance wound drainage, reduce the risk of infection, and support the development of granulation tissue, a key component in the wound healing process[9,10]. The negative pressure system not only facilitates the drainage of fluids, but also enhances the perfusion of surrounding tissues, which can accelerate the healing process[11]. Furthermore, EndoVAC application shields the cavity from exposure to highly acidic gastric juices, which can be erosive, while simultaneously removing microbial load and excess interstitial fluid[2].

An initial endoscopic examination of the anastomotic area, supplemented by computed tomography, is performed to evaluate the defect size, the associated cavity, and its proximity to major vessels[12]. The index endoscopy should be done in a short period of time without debridement or irrigation of tissues, ideally insufflating CO₂ instead of O₂ in order to avoid air embolism or further dehiscence with endoscopes of up to 10 mm in width[13]. This evaluation guides the decision between intraluminal or intracavitary sponge placement[14]. The procedure involves the endoscopic placement of a tailored polyurethane sponge, attached to a nasogastric tube, into the defect or cavity[13,15,16]. Continuous suction of 100 mmHg is applied, with sponge changes every 3-5 days until healing is complete[13]. Several authors report sponge changes every 4 days to 7 days, with differing pressure levels ranging from 75 mmHg to 125 mmHg[14,17]. A recent experimental animal study showed that -125 mmHg significantly improved perfusion in ischemic gastric conduits post-esophagectomy, suggesting a possible preventive role for EndoVAC in cases of poor arterial or venous supply[18].

CLINICAL OUTCOMES AND ADVANTAGES

EndoVAC has emerged as a significant treatment option for the management of ALs following esophagectomy[19]. Pattynama et al[20] conducted a retrospective analysis of 38 patients, as well as a prospective single-center clinical trial, and reported an overall success rate of 74% in achieving defect closure, with a relatively low adverse event rate of 5%. Mennigen et al[21] carried out a single-center retrospective study and demonstrated even greater effectiveness, with EndoVAC showing an initial healing success rate of 93.3% compared to 63.3% for metal stents in post-esophagectomy AL. Additionally, Schniewind et al[22] in a retrospective single-center study of 62 patients with post-esophagectomy AL highlighted EndoVAC’s superiority, particularly in critically ill patients, achieving the lowest mortality rate (12%) compared to both metal stent placement and surgical intervention. Berlth et al[23] in a retrospective study of 111 patients reported an overall closure rate of 85.7% for EndoVAC compared to 72.4% metal stents, but these findings were not statistically significant. These findings underscore EndoVAC’s effectiveness, suggesting it may be a safer and less invasive alternative to traditional interventions for managing esophageal defects. This technology has shown particular promise in treating post-operative complications, with reported success rates supporting its use as a first-line intervention for managing esophageal leaks[11].

Several comparative studies underline EndoVAC’s advantages over alternative techniques such as self-expanding metal stents (SEMS), as shown in Table 1. Brangewitz et al[24] in a retrospective analysis of 71 patients found EndoVAC to have an 84.4% success rate in managing intrathoracic leaks, significantly higher than the 53.8% success rate with metal stents, though mortality rates and overall hospitalization lengths were comparable. El-Sourani et al[25] in a retrospective analysis of 141 Ivor Lewis esophagectomies and 28 ALs reported an EndoVAC closure rate of 92.3% and no related complications, whereas SEMS therapy was successful in 85.7% of patients with 28.6% procedure related complications. A systematic review and meta-analysis of five retrospective studies and 274 patients by Scognamiglio et al[26] further reinforced EndoVAC’s superiority, demonstrating a higher odds ratio of 3.14 for successful leak closure, shorter treatment duration, and lower in-hospital mortality compared to SEMS. Similarly, a meta-analysis of 163 patients confirmed EndoVAC’s superior efficacy, with significantly higher closure rates, shorter hospital stays, and reduced morbidity compared to stent therapy[27]. Procedural factors, such as placement techniques and patient-specific conditions, significantly influence outcomes. For instance, Book et al[28] in a retrospective analysis of 116 patients reported higher success rates for intraluminal placement (86%) compared to intracavity placement (70%), whereas Jung et al[29] in a multi-center retrospective study of 119 patients found the opposite, favoring intracavity over intraluminal placement (success rates of 61.7% vs 38.3%). Furthermore, complications like bleeding or device dislocation negatively impacted EndoVAC outcomes[28]. The novel VACStent, combining EndoVAC with a covered metal stent, demonstrated promising results in preliminary studies, achieving high technical and clinical success rates while maintaining GI patency, though larger-scale validation is still required[30-34]. Overall, EndoVAC emerges as a superior, though more resource-intensive, treatment modality compared to conventional techniques, particularly for severe AL cases.

Table 1 Studies comparing endoscopic vacuum therapy to other treatment modalities of anastomotic leakage after esophagectomy.

Ref.	Study design	Patients	Success rate	Key findings
Brangewitz et al[24]	Retrospective	71 (32 EndoVAC, 39 SEMS)	Closure rate: 84.4% (EndoVAC) vs 53.8% (SEMS)	Closure rate was higher in the EndoVAC group
Schniewind et al[22]	Retrospective	62 (17 EndoVAC, 12 SEMS, 18 surgeries, 15 conservative)	Mortality: 12% (EndoVAC) vs 50% (surgery) vs 83% (SEMS)	EVT patients had lower mortality compared to surgically treated cases and SEMS
Mennigen et al[21]	Retrospective	45 (15 EndoVAC, 30 SEMS)	Closure rate: 93.3% (EndoVAC) vs 63.3% (SEMS)	Success rate was higher for EndoVAC
Berlth el al[23]	Retrospective	111 (35 EndoVAC, 76 SEMS)	Closure rate: 85.7% (EndoVAC) vs 72.4% (SEMS)	EndoVAC and SEMS show comparable results
El-Sourani et al[25]	Retrospective	28 (13 EndoVAC, 7 SEMS, 4 surgery, 1 hemoclip, 3 conservative)	Closure rate: 92.3 (EndoVAC) vs 85.7% (SEMS)	EndoVAC can be successfully applied in the treatment of anastomotic leakage in critically ill patients, while SEMS should be limited to clinically stable patients with a small defect size

EndoVAC: Endoscopic vacuum therapy; SEMS: Self-expanding metal stent; EVT: Endoscopic vacuum therapy.

The management of ALs typically involves patient’s resuscitation, control of contamination, and nutritional support[35]. EndoVAC enables controlled drainage, sepsis containment, and promotion of granulation tissue, supports defect closure and mitigates further complications, even in hemodynamically unstable or septic patients[36]. While type I leaks can be treated conservatively, our center’s extensive experience with AL management supports the prompt use of EndoVAC in all suspected AL cases, without waiting to classify the leak type. As shown by Oesophago-Gastric Anastomosis Audit, conservative treatment fails in a significant percentage of initially classified type I leaks[1]. Therefore, we strongly recommend that a suspected AL should be managed with EndoVAC as early as possible, ideally within 6 hours of diagnosis, without waiting classification purposes. This aggressive, early intervention is particularly crucial for critically ill or hemodynamically unstable patients and should be performed in high-volume centers with multidisciplinary expertise in complex endoscopic procedures to ensure effective sepsis control and maximize recovery potential[37]. Reimer et al[37] in a single-center retrospective analysis of 92 patients showed that placing EndoVAC within 6 hours of suspected AL leads to a significant improvement in leak closure rates and patients’ recovery in comparison to its late implementation. Using EndoVAC as a first-line therapy in all cases ensures effective sepsis control, leak containment, and tissue healing[26]. This strategy promotes rapid decompression of the infected area, reduces contamination risk, and maximizes recovery potential[18,20]. EndoVAC is versatile, applicable to all AL types. This adaptability underscores its potential as a first-line treatment modality in various clinical scenarios[38,39]. The technique’s ability to effectively manage different leak presentations makes it a valuable addition to the surgical arsenal for treating post-esophagectomy complications. Adopting EndoVAC universally in suspected AL cases enhances care consistency and outcomes, solidifying its role as the gold standard in esophagectomy-related AL management.

Despite the initial costs associated with EndoVAC therapy, its use may lead to significant overall healthcare savings by reducing the need for prolonged hospitalization and additional interventions related to complications. The treatment of ALs can be extremely costly, with per-patient expenses exceeding 70000 Euros, largely due to extended length of hospitalization and the need for repeated diagnostic and therapeutic procedures[40]. By promoting effective leak resolution and minimizing the necessity for reoperation, EndoVAC has the potential to lower these expenditures, but the economic impact of endoscopic vacuum therapy varies significantly across studies. Baltin et al[40] reported that EndoVAC for esophageal AL after esophagectomy incurred a higher financial burden compared to SEMS, resulting in an average deficit of 9282 Euros per case vs 5156 Euros for SEMS, primarily due to longer hospitalization and limited reimbursement. Similarly, Ward et al[41] demonstrated that performing EndoVAC in a gastrointestinal lab rather than the operating room could reduce total costs by approximately 2.5 fold. In our experience, a homemade EndoVAC system can be assembled for under 500 Euros without compromising therapeutic effectiveness, a finding supported by other studies on cost-effective, improvised EndoVAC systems[2,42]. To ensure broader accessibility and sustainability, further research is needed to address the cost-effectiveness and reimbursement challenges of EndoVAC across diverse healthcare settings.

CONCLUSION

The management of post-esophagectomy AL is evolving, with EndoVac therapy being a paradigm shift in the management of post-esophagectomy ALs, emerging as a highly effective first-line treatment. As the understanding of AL mechanisms improves, future research is expected to refine the application and effectiveness of EndoVac therapy in clinical practice. Understanding the impact of this therapy on quality of life, recurrence rates of leaks, and overall survival will help establish its role within the broader context of esophageal surgery management. Additionally, evaluating the impact of EndoVac on healthcare resources and costs could inform healthcare policies and guidelines.

Substantial evidence demonstrates that EndoVAC offers superior leak closure rates, shorter hospital stays, and lower morbidity compared to traditional methods like stenting. Its ability to actively drain septic foci while promoting tissue healing makes it an invaluable tool for managing this life-threatening complication. Despite its success, significant challenges remain. The procedure is operator-dependent, requires multidisciplinary teams, involving surgeons, gastroenterologists, and radiologists, and is best performed in high-volume centers. Furthermore, the lack of standardized protocols for application and duration, alongside concerns regarding cost-effectiveness and reimbursement, currently limit its widespread adoption.

Further studies are needed to solidify EndoVAC’s role as the standard of care; future research must focus on several key areas. Prospective, multi-center randomized controlled trials are essential to definitively establish its efficacy over SEMS and other interventions. The development of standardized, evidence-based protocols is necessary for optimizing outcomes and ensuring reproducibility. Finally, rigorous cost-effectiveness analyses are required to inform healthcare policy and ensure equitable access to this transformative therapy.