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Ann Thorac Surg 2007;83:2003-2008
© 2007 The Society of Thoracic Surgeons


Original Articles: General Thoracic

Esophageal Stent Placement for the Treatment of Iatrogenic Intrathoracic Esophageal Perforation

Richard K. Freeman, MD*, Jaclyn M. Van Woerkom, RN, BSN, Anthony J. Ascioti, MD

Department of Thoracic and Cardiovascular Surgery, St. Vincent Hospital, Indianapolis, Indiana

Accepted for publication February 9, 2007.

* Address correspondence to Dr Freeman, 8433 Harcourt Rd, Suite 100, Indianapolis, IN 46260 (Email: rfreeman{at}corvascmds.com).

Presented at the Fifty-third Annual Meeting of the Southern Thoracic Surgical Association, Tucson, AZ, Nov 8–11, 2006.


    Abstract
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 
Background: Iatrogenic esophageal perforation after endoscopy or surgery can be a devastating event. Traditional therapy has most often consisted of operative repair of the esophagus. This investigation summarizes our experiences treating iatrogenic intrathoracic perforations of the esophagus using an occlusive removable esophageal stent.

Methods: Over a 24-month period, patients found to have an iatrogenic intrathoracic esophageal perforation at a tertiary care medical center were offered endoluminal esophageal stent placement instead of operative repair of the esophagus as initial therapy. Excluded were patients with an esophageal malignancy or a chronic esophageal fistula. Silicone-coated stents were placed endoscopically utilizing general anesthesia and fluoroscopy. Adequate drainage of infected areas was also simultaneously achieved. Leak occlusion was confirmed by esophagram. Patients were followed until their stent was removed and their esophageal leak had resolved.

Results: Seventeen patients had 18 esophageal stents placed for acute perforations of the esophagus after endoscopy (8) or surgery (9) during the study period. Associated endoscopic (13) or surgical procedures (7) were performed simultaneously in all 17 patients. Leak occlusion occurred in 16 patients (94%) as confirmed by esophagram. Fourteen patients (82%) were able to initiate oral nutrition within 72 hours of stent placement. One patient (6%) experienced a continued leak after stent placement and underwent operative repair. Stent migration requiring repositioning (2) or replacement (2) occurred in 3 patients (18%). All stents were removed at a mean of 52 ± 20 days after placement. Hospital length of stay for patients treated with esophageal stent placement was 8 ± 9 days (median, 5).

Conclusions: Endoluminal esophageal stent placement is an effective method for the treatment of acute, iatrogenic perforations of the intrathoracic esophagus. These stents result in rapid leak occlusion, provide the opportunity for early oral nutrition, may significantly reduce hospital length of stay, are removable, and avoid the potential morbidity of operative repair.


    Introduction
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 
Perforation of the esophagus during endoscopy or surgery can be a devastating complication for patients and a challenge for the surgeon asked to intervene. Mortality after perforation of the intrathoracic esophagus treated with operative repair continues to range between 12% and 50% in the majority of modern series despite advances in surgical technique, critical care and antimicrobial therapy [1]. Recently, esophageal stent placement, in various forms, has been used to supplement the treatment of esophageal fistulas and anastamotic leaks [2, 3]. Modern esophageal stents offer occlusive, removable prostheses that are easily placed. Our own experience with the Polyflex esophageal stent (Polyflex; Boston Scientific, Natick, Massachusetts) in patients with recalcitrant esophageal fistulaa, led us to consider their use in patients with iatrogenic perforations of the esophagus [4]. If a hybrid operative and endoscopic treatment strategy could be used to achieve the traditional goals of operative treatment of perforation of the intrathoracic esophagus, perhaps the morbidity, mortality and recuperation time of these patients could be reduced. This investigation reviews our experience treating a group of patients with an iatrogenic perforation of the intrathoracic esophagus using an endoluminal esophageal stent.


    Patients and Methods
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 
A nonrandomized, prospective, observational study of patients referred to the thoracic surgery service at a tertiary care medical center for iatrogenic intrathoracic esophageal perforation was conducted over a 24-month period. All patients with a documented esophageal leak after endoscopy, esophageal instrumentation, or nonesophageal surgery who would have otherwise been offered surgical repair, were offered participation in an Institutional Review Board–approved protocol using an endoluminal esophageal stent to treat their intrathoracic perforation. Patients gave informed consent for the study as well as the procedure. Patients with a cervical or intra-abdominal esophageal perforation, perforation from another etiology, and patients with an esophageal malignancy were excluded. Also excluded from participation were patients who had undergone previous operative repair of an esophageal perforation with a subsequent leak. The presence of an intrathoracic esophageal perforation resulting in the extravasation of oral contrast into the mediastinum, pleural space, or peritoneum was documented and localized by gastrograffin or barium esophagram, or both, before any treatment (Fig 1). Additionally, all patients being considered for stent placement underwent computer-aided tomographic imaging of the neck, chest, and abdomen.


Figure 1
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Fig 1. Gastrografin esophagram of a patient displaying a distal, intrathoracic esophageal perforation. The brisk extravasation of contrast can be seen flowing over the dome of the left hemidiaphragm in the pleural space.

 
All esophageal stents were placed in the operating room using general endotracheal anesthesia and fluoroscopy by a thoracic surgeon after flexible esophagoscopy (Fig 2). A percutaneous endoscopic gastrostomy was placed immediately before esophageal stent placement in patients without recent abdominal surgery to allow for enteral nutrition and gastric drainage. Adequate drainage of infected areas was also simultaneously achieved. Occlusion of the esophageal perforation was confirmed by contrast esophagram a minimum of 48 hours after stent placement or when the patient was able to participate in the examination (Fig 3). In the absence of a continued leak, a "soft mechanical" diet without bread or meat was initiated and advanced as tolerated to a "postgrastrectomy" diet.


Figure 2
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Fig 2. Endoscopic finding displaying the esophageal perforation recognized on esophagram (Fig 1).

 

Figure 3
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Fig 3. Barium esophagram 3 days after endoscopic esophageal stent placement for an iatrogenic esophageal perforation. The proximal marker of the stent can be seen in the distal esophagus. The previous extravasation of contrast (Fig 1) is no longer present.

 
It was the intention to remove all patients’ esophageal stents after a sufficient amount of time to allow closure of the perforation. This intention was individualized based on the etiology of the perforation, anatomic location, nutritional status of the patient, and the resolution of all associated infectious or septic factors but was not less than 14 days after initial stent placement. Stent removal was carried out in the operating room under general anesthesia. Flexible esophagoscopy was performed before and after stent removal as well. An esophagram was obtained 24 hours after stent removal to exclude recurrent leak. Patients were followed until their stent had been removed and they were tolerating oral nutrition. All patients were assessed at least 1 month after stent removal for dysphagia.

Continuous data for this investigation are expressed as the mean plus or minus the standard deviation of the mean except where otherwise indicated.


    Results
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 
During the 24-month study period, 20 patients were evaluated by the authors at the study institution for an acute, iatrogenic perforation of the intrathoracic esophagus. Eighteen patients met the investigation’s inclusion criteria, 17 of whom could give informed consented to participate. One patient was not able to give informed consent and so was excluded from participation in this investigation. Follow-up was complete in all of these 17 patients for the study period. Their mean age was 54 ± 20 years (range, 17 to 91). The endoscopic etiology (8 patients) of their esophageal perforations were esophagogastroduodenoscopy with removal of a foreign body (3), esophageal dilatation (2), diagnostic biopsy (1), endoscopic ultrasonography (1), and attempted endoscopic antireflux procedure (1). Surgical perforations (9 patients) resulted during procedures for anterior spine discectomy and fusion (3), reoperative thoracic aortic aneurysm repair (2), laparoscopic antireflux procedure (2), reoperative decortication (1), and laparoscopic paraesophageal hernia repair (1; Table 1). Nine patients were seen in consultation as inpatients after their endoscopy or surgery, and 8 patients were transferred from other hospitals before their evaluation. Eleven patients (65%) displayed signs and symptoms of mediastinitis at the time of their initial evaluation by a thoracic surgeon as defined by chest pain, fever, leukocytosis, and dyspnea. Four other patients (24%) displayed findings consistent with sepsis when evaluated. Mean time from perforation to stent placement was 39 ± 39 hours (range, 3 to 121). All 17 patients underwent additional endoscopic (13) or surgical (7) procedures at the time of stent placement (Table 2), the most common of which was for enteral feeding access.


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Table 1 Patient Demographics
 

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Table 2 Associated Endoscopic and Surgical Procedures
 
Mean days from stent placement until repeat esophagram was 3 ± 3 days (range, 2 to 11; median, 3). The most common reason for delay of the esophagram beyond 24 hours was the need for mechanical ventilation. Occlusion of the esophageal perforation occurred in 16 patients (94%) as demonstrated by the esophagram. All 16 patients were able to be started on an oral intake regime as outlined above, 14 (82%) within 72 hours of stent placement. Four patients who had undergone recent abdominal surgery with manipulation of the stomach did not have a percutaneous endoscopic gastrostomy attempted nor were they subjected to celiotomy for jejunostomy placement. Instead, they were maintained on total parenteral nutrition an average of five days after stent placement until an oral diet could be initiated.

Stent migration requiring repositioning (2) or replacement (2) occurred in 3 patients (18%). Polyflex stents in were removed in all 16 patients without residual esophageal leak at a mean of 52 ± 20 days (range, 17 to 91). None of these patients required further surgery for their esophageal perforation. Hospital length of stay varied because of the etiology of the esophageal perforation, associated complications, and preexisting comorbidities. The mean was 8 ± 9 days (range, 3 to 38; median, 5).

All stent placements occurred without intraoperative complication. One patient with a perforation of the esophagus in close proximity to the gastroesophageal junction showed clinical and radiographic evidence of a persistent esophageal leak and underwent conventional primary surgical repair 3 days after stent placement. The difficulty of this patient’s surgery was not increased by previous stent placement. Other associated morbidities in the study population included respiratory failure (1), myocardial infarction (1), and deep venous thrombosis (1). No patient in this series developed a symptomatic esophageal stricture after stent removal during the follow-up period. There were no deaths in this series of patients.


    Comment
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 
Iatrogenic perforation of the intrathoracic esophagus remains a life-threatening complication despite the significant advances that have occurred in surgical technique and supportive care. Perforations diagnosed and treated surgically within 24 hours continue to have an associated mortality rate between 12% and 36% [5]. Esophageal perforations recognized and treated more than 24 hours after they occur still produce rates of mortality between 30% and 50% [6, 7]. These results reflect the systemic inflammatory response or sepsis associated with an esophageal perforation as well as the stress of the extensive surgery often required. This significant rate of morbidity and mortality is exclusive of the incidence of failure after operative repair, which can require further surgery including esophagectomy [8, 9].

Nonoperative therapy for perforations of the esophagus has generally been reserved for the rare patient who is either not a candidate for surgery because of associated comorbidities or whose perforation fulfills a very narrow set of criteria defined by Cameron and colleagues [10] and subsequently modified by Altorjay and coworkers [11]. This treatment strategy has generally involved no oral intake, broad-spectrum antibiotics, and total parenteral nutrition. Surgeons are rightly concerned about treating patients in this manner as no direct efforts are made to close the perforation and eliminate the continued soilage of the mediastinum, pleura, or peritoneum, enteral nutrition is not usually utilized, operative drainage of contaminated spaces is exchanged for percutaneous methods, and mortality remains high, especially among patients whose perforation communicates with an adjacent pleural space [12].

An ideal treatment for iatrogenic intrathoracic esophageal perforation would be one that minimized the negative impact of the treatment itself on the patient while fulfilling the traditional goals of therapy for esophageal perforation: prevention of further contamination of the mediastinum by direct closure of the perforation, prevention of gastric reflux on the site of perforation, elimination of infection in the mediastinum and pleural spaces, maintenance or restoration of the integrity of the gastrointestinal tract, and preferably enteral nutritional support. Such a hybrid treatment approach to iatrogenic esophageal perforation would hold promise for effectively treating these patients while minimizing their recuperation time, morbidity, and mortality. However, a principal component of such a hybrid model has been missing: a method for sealing even relatively large perforations without the need for thoracotomy or celiotomy, or both.

Endoluminal esophageal stents have been used in the treatment of patients with an esophageal perforation. Initially, their use was in patients with a perforation associated with an esophageal malignancy [13]. Subsequently, reports of patients without an esophageal malignancy receiving a self-expanding metallic stent to treat an esophageal perforation were seen [14, 15]. These series showed promise for this form of therapy for perforations of the esophagus. However, concern remained over placing a stent that is not designed to be removed in a patient without a malignancy. Most recently, several series of 1 to 5 patients in which a silicone-covered plastic stent was used to treat various forms of esophageal perforation in heterogeneous groups of patients can be found [16–18]. In all these reports, however, the other traditional goals of surgical therapy were not generally pursued. Hence, as Brinster and associates [5] pointed out in their 2004 review, the role of endoscopy and endoluminal stent placement for esophageal perforation has not been well defined and could only be recommended for patients who could not tolerate surgery.

In an attempt to better delineate the usefulness of endoluminal esophageal stent placement for iatrogenic intrathoracic esophageal perforation, this investigation reviews our experience treating patients who would have otherwise undergone surgical primary repair of their intrathoracic esophageal perforation with a hybrid operative and endoscopic strategy. It combines the placement of a removable endoluminal esophageal stent used to seal an intrathoracic esophageal perforation without thoracotomy along with percutaneous gastrostomy to provide enteral nutrition and gastric drainage without celiotomy. Also, the simultaneous treatment of empyema and mediastinitis is by standard minimally invasive surgical techniques.

The results of this investigation produce several noteworthy findings. Endoluminal esophageal stent placement is very effective in rapidly sealing iatrogenic perforations of the esophagus, as demonstrated by contrast esophagram. This allowed earlier oral intake and a decrease in hospital stay than is the authors’ current practice or is reported in the literature after operative repair [6]. Stent migration requiring repositioning or replacement, reported to range between 7% and 30%, was minimal in this series and was treatable in all cases endoscopically [19]. Lastly, although there were significant morbidities in the study population, they occurred less frequently than reported in patients treated with operative esophageal repair after esophageal perforation [20, 21]. Furthermore, there were no deaths in the study population despite a significant delay in the diagnosis of esophageal perforation in the majority of patients. This finding is certainly in contrast to published series of patients whose esophageal perforation was treated surgically, and could be the result of the ability to effectively treat these patients without thoracotomy or celiotomy in the majority of patients [6, 7].

Integral to whatever success we may have achieved in caring for these challenging patients is the commitment to achieve the same goals one would entertain if operative repair was performed. In this series, every patient underwent at least one simultaneous endoscopic or surgical procedure to accomplish these goals. In our opinion, this global approach to these patients can only be provided with the involvement and preferably under the direction of a thoracic surgeon.

Although it would appear that endoluminal esophageal stent placement for iatrogenic intrathoracic esophageal perforation has distinct advantages over operative repair, this investigation has some weaknesses. While representing the largest number of iatrogenic esophageal perforations treated in this manner in the literature, a patient population of 17 remains a small number even for a relatively uncommon condition. Furthermore, no attempt was made to compare endoluminal therapy and operative therapy in either a prospective or retrospective fashion. That was because this investigation was designed to assess the feasibility and effectiveness of a new therapeutic strategy for iatrogenic esophageal perforation rather than compare stent placement and conventional therapy.

In conclusion, this series demonstrates the safety and effectiveness of an occlusive esophageal stent in treating patients with an iatrogenic intrathoracic esophageal perforation that would have otherwise required surgical repair. Endoluminal stent placement provides rapid closure of the perforation, eliminating soilage of the mediastinum, pleura, and peritoneum while avoiding the trauma of an urgent thoracotomy and celiotomy. Along with the associated procedures required to achieve the traditional goals of therapy in patients with an esophageal perforation, esophageal stent placement resulted in earlier oral nutrition, relatively little morbidity, and no mortality even when the diagnosis was significantly delayed. Based on the encouraging results of this investigation, consideration should be given to treating the majority of patients with an iatrogenic intrathoracic esophageal perforation with an endoluminal esophageal stent as part of a hybrid treatment strategy in which thoracotomy and celiotomy are not routinely required.


    Discussion
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 
DR SCOTT B. JOHNSON (San Antonio, TX): Doctor Kern, Dr Moon, I would like to first thank the Southern Thoracic Surgical Association for the invitation to discuss this paper and to also thank Dr Freeman for graciously sending me his manuscript well in advance of the meeting. I would also like to congratulate him for taking the initiative to step out of the box and developing new technology and new innovative techniques and applying it to an old problem in treating what has historically been a difficult group of patients for thoracic surgeons to deal with. As we all know, new ways to treat old problems initially always seems to be met with quite a bit of doubt and skepticism, although your results appear quite promising. In this regard, it appears that your stent is relatively easy to insert, achieves temporary closure of the perforation, and just as importantly, allows itself to be readily removed once adequate healing of the perforation has occurred and its purpose accomplished. I just have three questions for you.

First of all, it is stated in the manuscript that all patients had adequate drainage of their infected areas simultaneously achieved, yet it appears that only 6 patients underwent associated tube thoracostomy or video-assisted thoracoscopic decortication, or both. My question is how was adequate drainage achieved and confirmed in the remaining 11 or so patients?

Secondly, these patients obviously represent a heterogenous group of people, some with primary underlying esophageal disorders and others without. My second question to you is what have you learned in terms of what group of patients, if any, might benefit the most from this form of therapy?

And lastly, in your experience in treating these patients, are there any characteristics of an iatrogenic perforation that you might see either on a swallow study or during your own endoscopy that would make you shy away from insertion of a stent and instead lead you to performing immediate surgery? I would like to congratulate you on an excellent presentation and again thank the Association for the opportunity to discuss this paper.

DR FREEMAN: Thank you, Dr Johnson, for your comments. As for your questions, the question regarding drainage of infected areas was based on CT scans performed before stent placement. As you point out, 6 patients in this series underwent additional procedures. Additionally, 6 patients in the series suffered an esophageal perforation during an unrelated surgery that involved a thoracotomy, and so they had their mediastinal pleura opened with chest tubes in place. The remaining 5 patients, then, out of the series were acute iatrogenic perforations usually during endoscopy, and we did not have any evidence of contamination of the mediastinum or pleura at the time.

As for characteristics that are encouraging for stent placement for us, we certainly look for a focal perforation, one that is intrathoracic. We prefer it if we don’t need to cross the gastroesophageal junction with the stent, although we have, and have not had many problems with that. Obviously, we look for patients with distal obstruction or malignancy, who were not included in this study, and we would be very wary of placing a stent above a distal obstruction or malignancy.

As for your last question, patients who we are not enthusiastic about for placing a stent, we have had some problems with Boerhaave’s patients, and so tend not to treat those esophageal perforations endoscopically. If they are a reasonable candidate for surgery, they have a traditional surgical repair.

DR BRYAN FITCH MEYERS (St. Louis, MO): You mentioned that this is a prospective observational study with 17 patients who consented. I just wondered if you could say anything about patients who didn’t consent to the study and what you did for them, and also patients who were referred to you during this time period with esophageal perforation that you chose not to treat this way. If you could characterize these patients, it would give us a little clearer view of the selection process.

DR FREEMAN: Thanks, Bryan. The manuscript details 20 patients who we saw during this time period for iatrogenic perforation. Two of those had distal malignancies and did not undergo stent placement but underwent partial esophagectomy. The remaining patient was not someone who could consent and so was not enrolled in the study. However, that patient was treated with a stent and did well. But their data could not be included in this review because of the consent issue.

DR KAMAL A. MANSOUR (Atlanta, GA): I enjoyed the presentation. You actually embarked on a new technology for esophageal perforations, and I have four observations here. The first, in only 2 years, you have 18 perforations. That is a lot of perforations in 2 years. What are you doing wrong? Number two, you are, as I said, introducing a new technology with the stent. Do you get permission, patient consent, for this? Do you tell them that this is not the standard we keep and we are doing something new? Number three, what keeps the stent in place? You have four migrations, and this is just silicone-coated stent, no prongs or anything else. Number four, would the stent interfere with the motility of the esophagus, with the peristalsis? You are putting that segment of the esophagus out of function, and that will interfere with the peristalsis and eating. You keep that prosthesis for 2 months, you said, and you feed the patient. I don’t know how you do that. And lastly, do you do this for all perforations, like spontaneous Boerhaave’s perforations? What would you do with this? Thank you.

DR FREEMAN: Thank you. We are really only one of about two hospitals in our state that have a comprehensive thoracic surgery service, and so we see patients from all over the state. I believe in this particular series, 8 patients came from outside our hospital and were transferred in. As far as consent, they are told that this is something new, that they don’t have to have this done, that we evaluate them, and we get consent in this particular study.

As far as migration goes, we had 3, which was 18%, which is a little lower than our other series of patients with chronic fistulas that we treated with stents, and again, we oversize the stent, especially in length, and that seems to help. As for motility, I am sure it affects motility, probably not as much as an operation, but we obviously treat these patients as if they have aspiration risk after the stent is placed. We don’t normally treat Boerhaave’s patients with this technique. We have had some difficulty with those patients, although our last stent placement was for an elderly patient with Boerhaave’s who did quite well.

DR BILL PUTNAM (Nashville, TN): The underlying etiology that preceded the iatrogenic perforation still existed. The stent temporized things quite well. What were the long-term outcomes? Were operations required in these patients later on or did the stent relieve the underlying problem for which the perforation occurred?

DR FREEMAN: Thank you, Dr Putnam. There were no further esophageal surgeries required in this population. If you look back at the etiology of the perforations, in the surgical group, again, we excluded patients who were having esophageal surgery. So it is not esophageal surgery. The endoscopic indications were mostly foreign body removal, endoscopic ultrasound, things like that. So we purposely did not look at patients who had underlying esophageal disease and then were perforated. And again, of the patients who were treated in this respect, no one had further esophageal surgery.


    References
 Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 References
 

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