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Ann Thorac Surg 2008;85:1962-1967. doi:10.1016/j.athoracsur.2008.02.043
© 2008 The Society of Thoracic Surgeons
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Original Articles: General Thoracic

Utility of Silicone Esophageal Bypass Stents in the Management of Delayed Complex Esophageal Disruptions

Anthony W. Kim, MDa,c, Michael J. Liptay, MDa,c, Norman Snow, MDb,c, Philip Donahue, MDb,d,c, William H. Warren, MDa,d,c,*

a Department of Cardiovascular-Thoracic Surgery, Rush University Medical Center, Chicago, Illinois
b Department of General Surgery, Rush University Medical Center, Chicago, Illinois
c Department of Surgery, University of Illinois, Chicago, Illinois
d John H. Stroger Hospital of Cook County, Chicago, Illinois

Accepted for publication February 13, 2008.

* Address correspondence to Dr Warren, Division of Thoracic Surgery, Rush University Medical Center, 1725 W Harrison St, Suite 774, Chicago, IL 60612 (Email: william_warren{at}rush.edu).

Presented at the Fifty-fourth Annual Meeting of the Southern Thoracic Surgical Association, Bonita Springs, FL, Nov 7–10, 2007.


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Discussion
 References
 
Background: The objective of this study was to review the clinical experience of temporarily placing an endoesophageal silicone salivary bypass stent and its value in managing patients with life-threatening esophageal disruptions.

Methods: Clinical records of patients undergoing placement of silicone Montgomery salivary bypass stents from June 1998 to September 2007 were reviewed. Seventeen patients had a proven esophageal disruption in the absence of malignancy and with life-threatening sepsis refractory to conventional management. Underlying conditions were iatrogenic trauma from prior pulmonary surgery (4 patients), significant anastomotic leaks after an esophagogastrectomy (4 patients), delayed presentation (> 24 hours) of a perforated esophagus (4 patients), leak after esophageal surgery (3 patients), and esophagobronchial fistula secondary to inflammation and infection (2 patients). Stents were placed without securing, were sutured in place to the esophageal wall at the time of thoracotomy, or were secured by bringing holding sutures through the nostrils and tied over the bridge of the nose.

Results: In all cases, placement of the esophageal stent led to prompt improvement of the leak and, within a week, improvement of the sepsis. Supportive measures were continued after placement of the stent. Sixteen patients overcame the sepsis with ultimate healing of the esophageal disruption (13 patients) or maturation of the perforation into a chronic fistula (3 patients). Endoscopic stent removal was performed 2 to 16 weeks after placement. No patient had a stricture develop at the disruption site. One patient died of ruptured thoracic aorta.

Conclusions: Silicone salivary bypass stents serve as an effective way of diverting and excluding the oral-alimentary stream, thereby providing optimal conditions for sepsis control. They are a useful adjunct in the management of complex esophageal conditions.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 Discussion
 References
 
Montgomery salivary bypass stents were initially described in 1955 as a polyethylene tube used to bridge the gap between a pharyngostomy and esophagogastrostomy after laryngoesophagectomy, before reconstruction of a cervical esophagus [1]. The present day salivary bypass stent is constructed from medical-grade silicone, making the stent soft and pliable allowing easy delivery of the stent using the push-through technique. The diameters range between 8 to 20 mm (Fig 1). Since its introduction, there have been several additional indications for the use of these stents, including in the management of postlaryngoesophagectomy fistula, palliation of advanced pharyngeal and cervical esophageal cancer with severe dysphagia, reconstruction of the cervical esophagus, and managing traumatic injuries to the cervical esophagus [2, 3]. These stents have been used in the palliation of locally advanced middle third and distal third esophageal cancers [4–6]. Our experience with this stent in the setting of malignancy presenting either with stricture or fistula has been summarized in a previous publication [4].


Figure 1
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  		Fig 1. Salivary bypass stents: Montgomery salivary bypass stents come in an array of sizes ranging from 8 mm to 20 mm. All stents are 18-cm length.

 
The objective of this study was to determine if the nonexpanding silicone salivary bypass stent could be employed as a safe and effective adjunct in the management of esophageal disruption in the absence of an underlying malignancy.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 Discussion
 References
 
Clinical records of patients undergoing placement of silicone Montgomery salivary bypass stents from June 1998 to September 2007 were reviewed at three institutions: Rush University Medical Center, University of Illinois at Chicago Medical Center, and John H. Stroger Hospital of Cook County. Institutional Review Board approval was obtained to perform this retrospective review at all the participating institutions.

Patients were chosen on the basis of (1) proven esophageal disruption due to a benign histology, (2) life-threatening sepsis with the lack of a response to conventional management, and (3) placement of a salivary bypass stent. Benign underlying pathology was defined as either the original esophageal pathology having a benign etiology or after an operation for a malignancy in which all gross tumor was removed. Esophageal disruptions were classified into those due to emetic perforation and iatrogenic esophageal injury after pulmonary or esophageal surgery. Delay in diagnosis of a spontaneous perforation was defined as greater than 24 hours after emesis. Anastomotic leaks after esophagectomy for malignancy also were included provided there was no evidence of gross residual tumor. Infectious or inflammatory causes, with or without surgical intervention, were also included.

All stents were placed in the operating room. Smaller stents (14 to 16 mm in diameter) were passed over a flexible esophagoscope and pushed into position with 5/8" cardiopulmonary bypass pump tubing. This technique allowed the stent to be visualized directly as it traversed the disruption. Larger stents (18 to 20 mm in diameter) were mounted onto an appropriately sized bougie, and advanced into the esophagus with McGill forceps. Final positioning was accomplished using a rigid esophagoscope. With large disruptions, stents could be placed directly into the esophagus across the operative field at the time of surgical exploration (Fig 2). Stents were placed without securing, were sutured in place to the esophageal wall at the time of thoracotomy, or were secured by bringing holding sutures through the nostrils and tied over the bridge of the nose.


Figure 2
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  		Fig 2. Operative photograph shows salivary bypass stent bridging anastomotic dehiscence between esophagus and stomach after a left thoracoabdominal esophagogastrectomy.

 
Age, sex, and the specific underlying pathology of the patients were recorded. There were 17 patients identified as meeting the inclusion criteria. The average age of this cohort was 59 ± 16 years (range, 18 to 79). The gender distribution was 11 males and 6 females. Four patients presented in transfer after a delayed diagnosis of a perforated esophagus. Iatrogenic trauma after pulmonary surgery was responsible for 4 perforations (pneumonectomy 3, left lower lobectomy 1). There were 4 anastomotic leaks treated by stenting after esophagectomy (Ivor-Lewis 2, transhiatal 1, left thoracoabdominal 1). Staple line leak after an esophageal diverticulectomy accounted for 2 cases and esophageal rupture after laparoscopic paraesophageal hernia repair and Nissen fundoplication accounted for a single case. An esophagobronchial fistula after a thoracic aortic aneurysm repair was included. An esophagobronchial fistula that developed after an attempted bronchoplasty for broncholithiasis was also included (Table 1). Patients excluded were those who had an esophageal perforation diagnosed within 24 hours of their disruption, or who had an incompletely resected malignancy, or those who had a primary or metastatic malignancy as the cause of a perforation or fistula.


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  		Table 1 Diagnosis
 
Barium or gastrograffin esophagograms were used to confirm esophageal disruptions in all of the patients presented in this series. Additional studies, such as computed tomography scans, were obtained on a case-by-case basis, usually dependent on the pathophysiology.

Outcome measures recorded included interval from presentation to operative intervention, length of stay after stent placement, interval to stent removal, and ultimate patient disposition (Table 2). Significant complications and inpatient mortality were also recorded.


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  		Table 2 Outcomes
 

   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 Discussion
 References
 
The mean time from presentation to stent placement was 11 ± 16 days (median, 6.5; Table 2). The range varied from 1 to 65 days. The mean length of stay after stent placement was 20 ± 13 days (median, 19). The range of time for hospitalization after stent placement varied from 1 to 45 days. Two patients were discharged 1 and 2 days after their stent placement whereas the remaining patients required prolonged hospitalizations (range, 4 to 45 days). The mean time to removal of stent was 38 ± 25 days (median, 36.5). Excluding a single patient who had the stent removed secondary to immediate migration, the time to stent removal ranged from 12 to 109 days.

In all cases, placement of the esophageal stent led to prompt control of the esophageal leak and, within a week, improvement of the sepsis. Supportive measures were continued after stent placement. Excluding 1 death (discussed below), 13 patients completely healed their esophageal disruptions. A leak persisted in 3 patients with maturation of the disruption into a fistula (Table 3). The first patient sustained an iatrogenic injury during a left lower lobectomy and a chronic esophagobronchial fistula developed. The second patient (laparoscopic paraesophageal hernia repair and Nissen fundoplication) eventually had the stent removed, but had a known fistula that was being drained adequately by periesophageal drains. The third patient was lost to follow-up.


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  		Table 3 Disposition
 
In actuality, not every patient had complete closure of their leaks at the time of their stent removal. Nine of 11 patients discharged from the acute inpatient setting with their stent in place eventually sealed their leaks. These patients had their stents removed during a separate procedure. Five patients had their stents removed as an inpatient during their original admission before discharge. Of these 5 patients, 2 had their stents removed before a documented closure of their leak, but were clinically stable to tolerate stent removal and also had adequate external drainage of their controlled fistula. One patient (iatrogenic injury after left lower lobectomy) had repeated stent migration that warranted stent removal. The remaining patient (Ivor-Lewis esophagectomy) went on to have a repeat thoracotomy to repair a gastric fistula. His anastomotic leak was noted to have healed with the salivary bypass stent but a fistula developed from a chest tube that eroded into the gastric conduit. This was considered to be a success of therapy because the anastomotic leak healed and the gastric conduit fistula was, in fact, due to a separate etiology. The stent was removed because it could not adequately exclude the gastric fistula. In follow-up, no patient had a stricture develop at the disruption site.

Stent migration occurred in 6 patients. Four underwent repositioning endoscopically, and 2 underwent stent removal. Nonstent-related complications including a gastrointestinal bleed and a small bowel obstruction (Table 4).


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  		Table 4 Complications
 
There was a single death (6%), of a patient who initially presented with an esophagopleural fistula after a left-sided pneumonectomy for cancer. The original resection of the pulmonary tumor required excision of the tumor from the surface of the aorta and the esophagus. This death was caused by a ruptured thoracic aorta. The patient's stent was placed several days after the original surgery after the identification of a leak and empyema. At the time of the uneventful esophageal stent placement, an Eloesser flap was created through which the dressing changes were being performed. After an emergent episode of bleeding into the packing, the patient was returned to the operating room, where under direct visualization, the aorta was noted to have ruptured requiring the placement of a prosthetic aortic graft. No evidence of greater esophageal injury was noted at this time, and the mucosal edges of the defect were approximated with Vicryl (Ethicon, Sommerville, New Jersey) sutures. An atheromatous plaque cultured from this operation ultimately demonstrated growth of Candida species. Despite adequate debridement with wound packing changes, the patient ultimately died of exsanguination at his aortic graft site 5 days after the attempted aortic repair. No autopsy was performed; however, the remainder of the patient's postoperative course suggested that the stent was effectively diverting the salivary contents. Furthermore, there was no leukocytosis or constitutional symptoms to suggest recurrent infection. There was no evidence that placement of the stent or the stent itself caused injury to the aorta.


   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Discussion
 References
 
Surgical dictum in managing esophageal perforation is that immediate exploration is mandatory, if performed within 24 hours of the disruption. This principle becomes more controversial when esophageal repair is attempted beyond this time period. When a perforated esophagus or anastomotic leakage is approached operatively beyond this point, the intensely inflamed, indurated, and friable tissue often makes suture closure an unrealistic option. In this setting, when primary closure and drainage is attempted, high failure rates can be expected.

It is in this setting, that the authors believe the temporary internal diversion of saliva can avoid further contamination and exacerbation of an already inflamed and contaminated field. This idea has been an extension of the practice behind repairing an esophageal perforation over a T-tube, a surgical option expounded by others [7, 8]. Montgomery salivary bypass stents have been recommended to be maintained for 4 to 6 weeks after laryngoesophagectomy and before placement of a native conduit during a second-stage operation [3].

The 17 patients included in this study either failed conventional therapy, or were presenting well after their original injury. The only other alternative therapy, by the time they presented, would have been a cervical esophagostomy (with or without esophagectomy or exclusion). Typically the patients were either in a septic state, or severely debilitated and unable to tolerate an extensive procedure. Owing to our heterogeneous patient population and the rarity with which we encountered the aforementioned conditions, a predetermined amount of tissue loss was not used to define a patient as optimal for a Montgomery salivary bypass stent. Rather, the entire clinical picture contributed to the use of these stents as a "bail out" alternative.

In this particular study, the mean time to stent placement from presentation was 11 ± 16 days. The primary reasons for a long interval from the time of presentation or diagnosis were initial attempts to manage the patient conservatively, delay in diagnosis, and delay in transfer. Similar delays have been reported in other clinical experiences [9–12]. In this and other reports, the patients selected for stent placement were thought to be too unfit for conventional operative intervention, either due to delays in initiating treatment or underlying premorbid conditions [9–14].

In this study, the mean length of stay after stent placement was either better than or comparable with other reports of managing esophageal disruptions by primary surgical repair without stent placement. Mean duration of hospitalization after primary repair (after delayed diagnosis of perforations without stent placement) has been reported to be 45 ± 17 days [15]. In one review of their self-expanding plastic stents (SEPS) experience, Hunerbein and colleagues [16] showed that no patients required repeat thoracotomy and the overall mean length of hospitalization was 35 days. The mean time to resuming oral intake was 11 days. Other studies have demonstrated that SEPS placement has resulted in shorter hospitalizations as well as an earlier resumption of oral intake after radiographic confirmation of a sealed anastomotic leak [17, 18].

Optimal time for the stent removal in this series could not be anticipated, but rather determined on an individual case-by-case basis. Animal models have used nonexpanding silicone stents as the scaffolding upon which a neoesophagus may be regenerated. These studies have suggested that adequate healing occurs to allow removal of these stents after a minimum of 4 weeks [19, 20]. Time to removal has been variable among patients having self-expanding metal stents (SEMS), with it occurring as long as 6 months after placement [9–11, 21, 22]. Time from initial deployment to stent removal has also been suggested to be 4 to 5 weeks after emetogenic rupture, because this is the time frame for healing when SEPS have been employed [21, 22]. In the Hunerbein SEPS series, the mean time to stent retrieval was actually 29 days. This was distinctly less that the SEPS series reported by Freeman and coworkers [17], with a mean time of 52 ± 20 days. Others have waited for shorter or longer periods of time without apparent sequelae [23].

As is the case for any type of stent, migration was the most frequent complication in this series [16, 18, 24, 25]. The rate reported in this series was slightly more than that described in other series [16, 17]. Although it is believed that the smooth surface and inability to expand are properties of the silicone stent that may predispose it to migrate, this was not our experience. All of the Montgomery salivary bypass stents were secured using one of the techniques described in the methods section. Migration was typically the end result of suture failure or anchoring tissue failure. Furthermore, when the stents migrated, their repositioning was extremely easy as the features elucidated actually made repositioning easier and safer than that experienced with expanding stents, and often done as a relatively quick procedure. All but one of the patients in the current study avoided a reoperation to reestablish foregut continuity. Reexploration after salivary bypass stent placement was performed in 1 patient in this series owing to an iatrogenic gastric fistula caused by a chest tube eroding into the conduit after an Ivor-Lewis esophagectomy. At the time of reexploration, the healing tissue held sutures well, in contrast to the inflamed and fibrotic tissue described after SEMS placement [26].

In our series, stent sizing was not a challenge because direct visualization and estimation of the stent size through the esophagoscope was possible, unlike SEPS placement. At deployment, if the stent size was either too small or too large, it could be retrieved easily and replaced immediately. Also, oversizing the salivary bypass stent did not result in infolding of the stent within the esophagus sometimes observed in SEMS and SEPS.

In this series, the problem of residual stricture formation was not observed. Occasionally at endoscopy or repeat esophagography, a "heaping up" of the mucosa was noted, but this was neither symptomatic nor long standing. Certain problems unique to expandable stents include those related to the high radial expansion force. While this may be beneficial in their deployment, their use in benign esophageal disruption may exacerbate the clinical situation by causing pressure-related mucosal changes or respiratory embarrassment from airway compression [25]. Another advantage of the Montgomery salivary bypass stent is that they are extremely soft, which allows them to be better tolerated. Increased radial force in the stent is believed to cause substantial mucosal inflammation and hyperplasia at the proximal and distal ends [27]. Tissue ingrowth with certain expandable stents can contribute to the inability to remove the entire stent after complete tissue healing [28]. Cumulatively, these changes increase the chance of new injury to the healing tissue during stent removal. A distinct advantage of the salivary bypass stent is that its retrieval at any time during the patient's recovery is extremely easy.

Our inpatient mortality (6%) was comparable or better than reported averages (14% to 31%) reported in the literature after primary repair of delayed diagnosis of esophageal perforation [15, 16, 29]. Similarly, our mortality rate was comparable with those reported after SEPS placement (0% to 25%) [16, 18]. In the Hunerbein [16] SEPS series, mortality was 0% after stent insertion versus 20% that occurred after attempts at operative repair without a stent. Langer and associates [18] worsened the anastomic leaks in 2 of their 24 patients, which prompted re-exploration. Ultimately, both patients died of pneumonia. In their series, 6 of 24 patients ultimately were reported as inpatient mortalities.

Based on their own experience and review of the English literature, Hramiec and associates [27] cautioned against the routine use of SEMS in benign esophageal pathology owing to the high short-term mortality rate (24%) and overall major complication rate of (67%). To date, no comprehensive review of the role of SEPS in esophageal disruption in the absence of malignancy exists. However, it is safe to say that stent complications and failure of therapy have been reported with sufficient frequency to warrant concern about their routine use in this clinical setting. Others may disagree [17], citing low mortality rates, but it can be countered that SEPS and SEMS removal alone, with their irregular surface, may cause additional tissue injury. The use of these smooth salivary bypass stents is much less likely to disrupt the healing tissue.

The overall number of patients who had esophageal perforation during the period of the study was estimated to be nearly 40 during the study period. The majority of these perforations were acute disruptions (< 24 hours of presentation) that were managed by the standard primary repair. Only 4 esophageal perforations, all of which had delayed presentations, were managed with the Montgomery salivary bypass stent. Likewise, the majority of anastomotic leaks after esophagectomy were managed successfully by the conventional nonoperative methods.

Wide mediastinal drainage was achieved in all of our patients with operative debridement and drainage either at the time of stent insertion (eg, delayed diagnosis of an esophageal perforation) or before placement of the stent (eg, anastomotic leak after an esophagectomy or leak through an esophagomyotomy closure after the resection of a diverticulum). The purpose of these stents was not to reestablish esophageal continuity per se, but to provide a tract by which saliva could be diverted and further mediastinal contamination could be avoided.

Delay in treatment for perforations of the esophagus is associated with a 27% mortality rate irrespective of the form of therapy provided. This rate decreases to 14% when primary repair is attempted [30]. Excluding the single patient lost to follow-up, 15 of our 16 patients (94%) survived. This remarkable survival rate may be indicative of the benefits of the temporary internal diversion afforded by the salivary bypass stent, while other adjunctive therapies continue. We believe that salivary bypass stents are an invaluable adjunct in the management of patients with life-threatening esophageal disruptions.


   Discussion
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Discussion
References
 
DR JOHN A. HOWINGTON (Cincinnati, OH): I would like to thank the Association and the program committee for the opportunity to discuss this paper. In addition, I would like to thank Dr Kim and Dr Warren and their colleagues for providing me with the manuscript in advance of today's meeting. I am going to be brief since we are running over a little bit on time. I have two questions in two related categories.

One relates to your prolonged length of stay after your stent placement at 20 days, a mean of 20 days. Now, you are to be complimented. These are difficult, challenging patients. Unlike the series that was presented to us at this time last year by Dr Freeman and colleagues where there was not sepsis in these patients, they showed and the group of Langer and colleagues showed that after a self-expanding stent, they did swallow studies within 1 to 3 days, resumed oral intake, and in general had a mean stay of about 5 days. Can you relate to us, when did you do swallow studies on these patients, when did you resume oral intake, and did that have an impact? Did you just as a routine wait several days before studying them or starting oral intake, and if you changed that algorithm, would that impact your length of stay?

My second question relates just to the actual nuts and bolts of doing this procedure. You showed the stent, showed a 16-mm stent you put over an esophascope and advanced that, pretty straightforward. In your manuscript you described the technique of an 18- or 20-mm stent, having to put that over a bougie, using McGill forceps and then a rigid scope. Were you comfortable pushing that with a rigid scope across a distal esophageal disruption, or did you choose the size of your stent based on the location of the leak? And did you, like other reports, have any cases where you felt that the pushing of the stent across an anastomotic or other disruption somewhat further opened that leak or extended the disruption in those cases?

Again, I compliment you on a nice presentation and excellent results in this difficult and challenging group. Thank you.

DR KIM: Thank you, Dr Howington, for your kind comments and questions. With regard to your first question inquiring about the prolonged length of stay, I cannot give a simple explanation as to why our patients had their length of stay. I can just say that their conditions warranted supportive care that resulted in our mean length of stay. Again, this stent is just an adjunct to antibiotics and effective drainage. Now, there are a number of papers that report either longer or shorter length of stays. Our results appear to fall in the center of that distribution. So I think it is on par with what has been reported.

Regarding the swallow studies, we never had a preset time in which we would get this exam. Typically, our practice has been to study our patients about a week later, and then judging by how the patients do, we obtain our follow-up swallow studies. In our series, the majority of our patients went home with their stent. Therefore, when we had them return to the office after discharge, we would get their follow-up swallow studies before their stent removal.

As for the procedure itself, the larger stents would sometimes be placed over the dilators at the time that the chest was opened. Other circumstances would allow for us to place the stents through the actual defect, as stated earlier. We never had an experience where pushing the stents through the esophagus would exacerbate the disruption, but it is a valid concern. I think that our experience speaks to the utility of these stents. They are very smooth, very soft, very pliable, so they are very easy to deploy. This results in the easy passage down the esophagus.

DR WILLIAM A. COOK (North Andover, MA): One of the continuing problems with any of these stents is that there is a lot of reflux through them, and a simple little trick that maybe everybody here doesn't know about is that if you cut a little "V" on each side of the distal end, it creates a flap. So that it will close when the pressure is higher in the stomach end, and it will prevent reflux through the stent.

DR KIM: That is very interesting. In preparing both this manuscript and presentation, I thought about the whole issue of reflux. In our series, reflux never seemed to be a problem. I think that this may be due, in part, to the fact that not all of our disruptions occurred at or near the gastroesophageal junction. But I think in the future, and certainly with these stents, we could consider cutting that V out and seeing how they perform in the lower perforations with respect to reflux.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Discussion
 References
 

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Anthony W. Kim
Michael J. Liptay
Norman Snow
William H. Warren
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