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Eur J Cardiothorac Surg 2000;18:505-512
© 2000 Elsevier Science NL
a Division of Thoracic and Cardiovascular Surgery, All Children's Hospital/University of South Florida School of Medicine, Suite 450, 603 Seventh Street South, St. Petersburg, FL 33701, USA
b Division of Pediatric Cardiology, All Children's Hospital/University of South Florida School of Medicine, St. Petersburg, FL, USA
c Cardio-thoracic Unit, Great Ormond Street Hospital for Children, London, UK
d Division of Otolaryngology, University of Bonn, Bonn, Germany
Received 6 September 1999; received in revised form 7 June 2000; accepted 12 July 2000.
Corresponding author. Tel.: +1-727-8226-666; fax: +1-727-8215-994
e-mail: jjacobs1{at}compuserve.com
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Abstract |
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 Top Abstract 1. Introduction2. Materials and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Key Words: Trachea • Bronchus • Carina • Stent
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1. Introduction |
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TopAbstract1. Introduction2. Materials and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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A variety of stents have been studied experimentally and/or used clinically to aid in the management of complex tracheal, carinal and bronchial stenoses. These stents include intraluminal expandable metal stents [1,3,8–10], intraluminal silastic stents [11,12], intraluminal absorbable stents [13], and even extraluminal stents placed during open airway surgery [14,15]. In an effort to elucidate the appropriate role of different stent types in the management of complex pediatric tracheal, carinal and bronchial stenoses, we reviewed our multi-institutional experience with airway stents in children.
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2. Materials and methods |
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TopAbstract1. Introduction2. Materials and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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The 28 children who had stents placed post tracheal reconstruction (age, 5 months–18 years; mean, 8.06 years; SEM, 1.13 years) had undergone a variety of surgical repairs and underwent stent placement either during their final tracheal reconstruction, during the postoperative period, or both. Table 1 presents data describing these 28 patients and depicts the initial etiological diagnosis of the tracheal pathology. All patients with cardiac pathology and/or pulmonary artery vascular slings underwent correction of these cardiovascular problems at the time of initial tracheal reconstruction (all patients with pulmonary artery vascular slings had associated ring cartilage formation that was also corrected surgically). Twenty-six of these children who had stents placed post tracheal reconstruction had undergone more than one prior tracheal surgery; many of these procedures were performed at a variety of referring hospitals. The prior tracheal reconstructions represented in this group of patients include tracheal resection and reanastomosis, pericardial patch tracheoplasty, cartilage and rib graft tracheoplasty, and tracheal allograft reconstruction. In Table 1, the surgical approach is described as cervical or sternotomy, and refers to the incision utilized to perform the final surgical tracheal reconstruction prior to stenting. Twenty-seven patients in this group had tracheal stenting with silastic stents and one patient had stenting of the trachea, carina and bronchus with customized carinal stents. The follow-up in this group of patients is 6.1 years (mean) (SEM, 0.8 years).
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The one neonate who had stenting as preoperative stabilization had a diagnosis of severe pulmonary artery sling with carinal compression making mechanical ventilation nearly impossible. Although preoperative stabilization with extracorporeal membrane oxygenation (ECMO) has been described to permit the salvage of similar patients [16], this child was successfully stabilized with stenting of the trachea, carina and bronchus with a customized carinal Q-stent. The child subsequently had successful surgical repair, via the technique described by Jonas et al. [17], permitting eventual hospital discharge with a stable airway without stents or a tracheostomy.
2.2. Stents
Three stent types were utilized: 29 silastic stents, five expandable metal stents and six customized carinal stents (four patients had two stents and one patient had four stents). Thirty children had tracheal stents, six children had bronchial stents, and two infants had customized carinal stents (three children had stenting of more than one area and two had stenting of all three locations).
The silastic stents (Dumon stents, Axiom, Lyon, France or Hood ‘bronchial stent with posts’, Hood Laboratories, Pembroke, MA) can be placed either at the time of surgery or in the postoperative period. One or two temporary silicone intraluminal stents can be placed during tracheal reconstruction and sutured to the native trachea with 4–6 single absorbable monofilament sutures. These sutures are placed at the upper and lower ends of the stents to minimize movement of the stents. The stent(s) will support the tracheal reconstruction, which may undergo an initial period of softening in the early days after surgery; this strategy may especially be useful for pericardial patch tracheoplasty and tracheal allograft reconstruction. Typically, these intraluminal stent(s) support the tracheal reconstruction until the tracheal reconstruction hardens and re-epithelialization has occurred. After bronchoscopy visually confirms that the granulation tissue no longer exists and that the inner surface of the tracheal reconstruction has undergone re-epithelialization (typically 2–6 months after tracheal reconstruction), the stent is removed. Endoscopic stent removal is usually not difficult because the absorbable sutures previously holding the stent will have dissolved. The stent can be grasped, rotated medially, folded onto itself, and withdrawn. After discharge from the hospital, bronchoscopic follow-up is utilized. Malacia of a reconstructed trachea may again be treated with the silastic stent by reinserting the stent with a rigid bronchoscope. In this report, silastic airway stents were utilized to temporarily stent the reconstructed airway after tracheal reconstruction; these stents were placed both surgically, during the tracheal reconstruction in cases of tracheal allograft reconstruction, and endoscopically, during the postoperative period, to treat malacia of a reconstructed trachea.
Metal stents (Palmaz balloon-expandable metallic stent, Johnson and Johnson Interventional Systems Co, Warren, NJ) may be placed either via fluoroscopy [10] or via the rigid bronchoscope [1,3,8,9]. While expandable metallic stents can easily be dilated with rigid bronchoscopy with or without simultaneous fluoroscopy, the initial placement can be facilitated by the simultaneous use of both fluoroscopy and rigid bronchoscopy. Dilute contrast can be injected into the trachea and the resultant tracheogram and bronchogram will allow for precise stent placement and balloon dilatation under both radiographic and bronchoscopic guidance. Although these stents can be serially re-dilated, they may be difficult or impossible to remove. In this report, balloon-expandable metallic stents were used as a treatment for tracheomalacia and bronchomalacia. Other reports have used these stents as a treatment for postoperative tracheal stenosis after tracheal reconstruction.
The customized carinal Q-stents are manufactured on site from flexible wire reinforced cardiopulmonary bypass straight venous cannulas (Fig. 1) . Multiple side holes are created at the tip of an appropriately sized flexible wire reinforced cardiopulmonary bypass straight venous cannula. These side holes permit ventilation of the non-stented bronchus after the stent is positioned to support the distal trachea, carina, and one (usually the left) bronchus. Two types of customized carinal stents have been used. One type keeps the entire length of the venous cannula intact; the venous cannula is thus brought out through the nose or mouth and connected to the ventilator. A second type cuts the length of the venous cannula (Fig. 1); the cut off venous cannula is positioned with a rigid bronchoscope and stents the distal trachea, carina and bronchus. The cut off stent allows for weaning and separation from the mechanical ventilator. A permanent black line is placed on the intended anterior wall of the stent to facilitate proper positioning of the previously created side holes. The side holes permit ventilation of the non-stented bronchus; thus, both lungs can be ventilated, allowing time for preoperative stabilization in a neonate or infant who would otherwise have no functional airway. In the setting of postoperative carinal stenosis, the stent can be alternated between one bronchus and the other during sequential stent changes with increasingly larger stents; again, the non-stented bronchus will always be ventilated through the properly positioned side holes.
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3. Results |
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TopAbstract1. Introduction2. Materials and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Early mortality occurred in one patient (1/33, 3.0%) who underwent tracheal allograft reconstruction at 5 months of age after 4 days of ECMO support. This child had undergone previous tracheoplasty at 2 months of age for congenital long segment tracheal stenosis and presented with severe recurrent long segment tracheal stenosis. ECMO was instituted as mechanical ventilation became impossible. Severe intraoperative pulmonary hemorrhage necessitated the continuation of ECMO postoperatively, and the child expired 10 days after tracheal allograft reconstruction, secondary to a catastrophic intraabdominal hemorrhage.
Late mortality occurred in five patients (5/33, 15.2%); however, only three patients (3/33, 9.1%) died late with tracheal problems. One infant with congenital long segment tracheal stenosis had a sepsis-related anastomotic dehiscence after primary tracheoplasty, and then failed patch revision. Subsequent mediastinitis required ECMO support. This infant later underwent tracheal allograft reconstruction after 4 days of ECMO to allow for local control of sepsis. The airway stabilized sufficiently to allow separation from ECMO 3 days after tracheal allograft reconstruction, but the child expired 3.5 months later, secondary to further sepsis and airway failure. A second small child died 4 months after tracheal allograft reconstruction from acute hemorrhage, thought to be due to granulation tissue or pulmonary hemorrhage. A third child with complex tracheal stenosis died 3.4 months after his second tracheal allograft reconstruction from acute onset of massive airway hemorrhage while at home.
Two other patients died late with functional airways. One victim of multiple trauma died from cardiac failure despite a completely functional airway after tracheal allograft reconstruction. A second late death occurred in a child with recurrent congenital long segment tracheal stenosis who died 18 months after tracheal allograft reconstruction from unrelated gastrointestinal problems, despite a completely functional airway.
Twenty-seven patients survived (27/33, 81.8%). The follow-up ranged from 4 months to 14 years. Seventeen patients are now asymptomatic and without airway problems. These 17 children have all demonstrated stable and functional airways without stents or tracheostomies. Ten children are still undergoing treatment. Of these, one patient has two intraluminal silastic stents supporting a malacic tracheal allograft. This patient had her stents removed, developed tracheomalacia at the allograft site, and requested stent replacement due to difficulty of breathing on exertion. She is living an active life with the stents in place, although she requires occasional bronchoscopy to remove granulation tissue near the stent orifices. Four additional patients still have a total of five Palmaz balloon-expandable metallic stent(s) in place; three have required periodic dilation of their stent(s) and all four will require further dilation of their stent(s). Finally, one child has a tracheostomy in place. This child had stenting of the trachea, carina and bronchus with a customized carinal stent when mechanical ventilation became nearly impossible after the collapse of a redo rib cartilage tracheoplasty; the carina is now stable and tracheomalacia of the mid-trachea is being temporarily managed with a tracheostomy as the child grows.
Of three patients who required preoperative ECMO [7,16], only one patient survived. At another institution, this 5-month-old infant failed attempted balloon dilation for congenital long segment tracheal stenosis and sustained a cardiopulmonary arrest after the procedure, requiring the initiation of ECMO. Four days later, tracheal allograft reconstruction was performed and ECMO was discontinued. The child was at home, without major airway problems, and growing normally [7,16]. However, tracheal stenosis recurred and was treated with a second tracheal allograft reconstruction 14.5 months after the original replacement.
Complications are related to stent type and location. Metal stents are essentially non-removable and require periodic dilation. They may stimulate granulation tissue formation and scarring, requiring bronchoscopic intervention. Silastic stents stimulate granulation tissue formation requiring periodic bronchoscopic removal. Carinal stents can migrate; several techniques are available to help manage this problem. The permanent black line placed on the intended anterior wall of the carinal stent facilitates proper positioning of the previously created side holes, and allows for stent position checks with a fiberoptic bronchoscope. Furthermore, the wire reinforced cardiopulmonary bypass straight venous cannulas are visible on chest radiographs; the wire reinforcement makes an excellent radiographic marker.
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4. Discussion |
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TopAbstract1. Introduction2. Materials and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Balloon-expandable metallic stents, such as the Palmaz balloon-expandable metallic stent, have been studied extensively in the laboratory [8]. They have also been utilized in a variety of clinical settings [1,3,9,10]. They may be placed either via fluoroscopy [10] or via the rigid bronchoscope [1,3,8,9]. The advantages include ease of insertion, availability of stents to fit very small trachea and bronchi, and the ability to dilate the stent over time as the child grows. The disadvantages include the formation of granulation tissue at the stent site, scarring and difficulty in removal. Indeed, in some patients, these stents may be nearly impossible to remove.
Silastic airway stents, such as the Dumon stents and the Hood ‘bronchial stent with posts’, are usually easily inserted and removed. Unfortunately, they do stimulate the formation of significant granulation tissue, necessitating bronchoscopic intervention. Another disadvantage is the increased amount of airway lumen occupied by these silastic stents; this partial obstruction of the lumen means that these stents are not ideal for very small airways, and especially, very small bronchi. Furthermore, these stents are unavailable in sizes small enough to stent the airways of the smallest patients. Even when the proper size is available, silastic stents can not be expanded and need to be removed and replaced if necessary to allow patient growth (ideally, the child will simply outgrow the need for the stent and can have the stent removed). Expandable plastic stents have been studied in an animal model with promising results [18].
The customized carinal Q-stents described in this report permit safe and effective temporary stenting of the carina and allow time for patient stabilization and growth. This type of carinal stenting is difficult, if not impossible, with the metal and silastic stents. Neonates and infants with carinal stenosis may become very unstable and extremely difficult to mechanically ventilate. These patients may be salvaged with ECMO, but carinal stenting may be safer, less costly and less prone to complications. Carinal stenting may buy time to stabilize the patient, either prior to definitive surgery or as a means to allow patient and airway growth. Clearly, the customized carinal Q-stents are home-made and have thick walls. Ideally, more refined carinal stents with thinner walls could be developed; unfortunately, the commercial development of such a stent may not happen because neonatal and infant carinal stenosis is rare. The customized carinal Q-stents described in this report may allow salvage of the rare neonates with complex carinal stenosis.
Complications can occur with any of the currently available pediatric airway stents. Airway reconstruction procedures have failed because of inappropriate stenting and inappropriate stent length [19]. Bronchial anastomoses can breakdown after stent placement [20]. Voice quality has been documented to be poor after some cases of tracheal reconstruction with stenting [21]. Granulation tissue associated with stenting has been shown to grow numerous bacteria, including Streptococcus viridans, Pseudomonas aeruginosa, non-hemolytic streptococci and Staphylococcus aureus [22]. Granulation tissue may also be obstructive and require removal.
In an effort to decrease these complications, numerous stent types are currently undergoing investigation. Extraluminal stents, placed during open airway surgery, have been studied extensively in an effort to avoid the known complications of intraluminal airway stenting [14,15]. A completely absorbable stent made of polyglactin 910 (Vicryl) filaments in a homogenous polydioxanone (PDS) melt has been studied in an animal model and appears promising [13]. In the experimental model of the absorbable stent, the stent showed complete biodegradability and sufficient suspensory properties. Theoretically, one could line a Vicryl matrix with epithelial seeds to create a truly epithelialized biocompatible stent. Intratracheal stenting with nitinol, an alloy with shape memory effect, has also been studied [23]. This nitinol stent changes shape with changes in temperature; therefore, by cooling the stent, one may reduce its size and facilitate insertion and removal, and by warming the implanted stent to body temperature, one may expand the airway.
The ideal pediatric airway stent remains elusive. Each currently available stent has its advantages and limitations. The proper stent must be matched to the clinical situation at hand. Complications may occur with pediatric airway stenting, but can usually be managed with appropriate intervention. Based on our experience reported in this manuscript, we make the following management recommendations concerning the role of airway stents in the management of pediatric tracheal, carinal and bronchial disease:
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5. Conclusion |
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TopAbstract1. Introduction2. Materials and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Footnotes |
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Appendix A. Conference discussion |
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TopAbstract1. Introduction2. Materials and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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Dr Jacobs: Infection is problematic when stenting the airway of a small child. A fair amount of research has been done to delineate what organisms grow in tracheal granulation tissue. However, we found that Pseudomonas is a very common organism in the endotracheal cultures of patients with airway stents. Methicillin-resistant S. aureus also tends to grow in these airways. So it is a challenge. The granulation tissue and infection are both quite challenging in these small babies.
Dr W. Klepetko (Vienna, Austria): I congratulate you on this nice overview of this large series. I have two remarks and one question.
In our early experience, we have used expandable metal stents in two infants; one of them was newborn, and we used it in the subcarinal region. After 6 months, we were supposed to take it out, and this was almost a disaster, we had to make an emergent resection of this. So, I would like to ask you how many of your patients had definitely expandable metallic stents and how many complications at the time of taking them out have you experienced?
And the second comment I would like to make, you have not mentioned this, but, since 2 or 3 years, there is an expandable Silastic, fully Silastic stent, available from the Roche Company. I think this is, especially in the indication of bronchomalacia, in these infants, an ideal stent.
Dr Jacobs: Let me address your comments in reverse order. First, I think that the expandable, non-metallic stents are clearly going to represent a huge breakthrough. I have no experience with these stents, but clearly they will solve some of the problems that we're talking about today. Expandable Silastic stents may indeed be useful for infantile bronchomalacia. Perhaps even more promising is the concept of a completely absorbable expandable stent made of Vicryl (polyglactin 910) and PDS. In an experimental model, this stent showed complete biodegradability and sufficient suspensory properties. Theoretically, one could line a Vicryl matrix with epithelial seeds to create a truly epithelialized biocompatible stent.
To answer your first question, four of the patients in our series have expandable metal stents. They have a total of five expandable metal stents, one in the trachea and four below the carina. We have not yet removed any expandable metal stents, but we have dilated them on several occasions. Yes, it certainly is a concern what will happen when these children outgrow these stents as teenagers. I do know of other centers that have had disasters when trying to remove these metal stents, and that is a very troublesome issue without a doubt.
Mr M. Elliott (London, UK): In Europe, I've taken out 2 metal stents now from patients who have had them put in by other surgeons previously. Neither of them were removable from above. The metal had become incorporated in the cartilage in the developing bronchus and trachea.
But, I think that the importance of the stent at this stage is that it is life-saving in the neonate or the infant. At a later stage, it is technically possible to do other procedures, either a pericardial patch enlargement of the trachea or an allograft enlargement of the trachea or bronchus. So, just because it is difficult to remove or creates secondary problems does not prevent its role as a life-saving procedure.
I think the danger with the expandable Silastic stent is that it may not have the tensile characteristics that are required in these very small babies. The cartilaginous constriction or severity of their bronchomalacia or external vascular compression is just so severe that I'm concerned that the Silastic stents will not be able to cope with the tensile stresses that are there.
Dr Jacobs: I would agree that one cannot underestimate the value of saving the life of a neonate by placing an airway stent and allowing that child to grow bigger to safely have a more complex airway reconstruction. An expandable metal stent can often get the patient and the surgeon out of a very difficult situation and allow the child to grow. The child may outgrow the airway problem, especially in some cases of airway malacia. If not, the surgeon can then come back at a later time when the child and airway are larger, and use any of a variety of airway reconstruction techniques.
It will be very interesting to see the clinical tensile strength characteristics of the expandable Silastic stents and the absorbable Vicryl stents. If they do indeed have the strength to support a collapsing airway in a neonate, they are going to aid in solving a pretty bad problem. But if they don not, then we are going to be faced with using the same options we currently have.
Dr C. Backer (Chicago, IL, USA): That was a very nice presentation, Jeff. We have now placed 14 Palmaz stents in eight neonates and infants, and I would really echo your experience. Although we did have one interesting case: a child had a tracheal Palmaz stent and required a tracheostomy for subglottic stenosis. During one of the child's tracheostomy changes, the stent came out with the tracheostomy. So, that one did sort of slip out. Based on our experience with the other ones, though, I would agree completely that it is very difficult to get these out. We actually studied this in rabbits before we did it in children. Even with direct pressure on a rabbit that had been sacrificed, with hemostats and mosquitoes, it was almost impossible to pry the stent out of the trachea.
The question I have for you is, our radiologists tell us that we can overdistend these expandable metal stents. Even though they say that they only go up to a diameter of, say, 10 or 12 mm, one can actually keep distending them further than that and the stent will simply keep getting shorter and get bigger in diameter. Do you have any experience with that?
Dr Jacobs: As of now none of the patients in our series with the expandable metal stents have grown to be large enough to require overdistension of the metal stent. But I would agree also that our cardiologists and radiologists have both told us that when the time comes, we should be able to just keep dilating these stents and overdistending them. I hope that that's the truth. Maybe in a few years I'll come back to Europe and let everybody know.
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TopAbstract1. Introduction2. Materials and methods3. Results4. Discussion5. ConclusionAppendix A. Conference...References |
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