Prosthetic reconstruction of the trachea and carina

Prosthetic reconstruction of the trachea and carina Twenty-six patients with tracheal stenosis owing to benign stricture and malignancy have had airway reconstruction with a molded silicone rubber prosthesis. In 8 patients the distal trachea and carina were replaced with a bifurcated graft. One individual with respiratory insufficiency could not be weaned from the respirator and died in 3 weeks. Two other patients with malignancy died 15 and 18 months following operation from disseminated cancer. The remainder are living from I to 5 years postoperatively. Eighteen individuals have had the trachea resonstructed with a straight graft of silicone rubber. In 5 patients with long strictures the prosthesis was invaginated into the upper and lower ends of the trachea. Thirteen individuals had circumferential resection of the airway with end-to-end anastomosis of the graft to the trachea. There was one early death from erosion of the innominate artery and 5 late deaths unrelated to the prosthesis.

William E. Neville, M . D . , Paul J. P. Bolanowski, M . D . (by invitation), and Hooshang Soltanzadeh, M . D . (by invitation), Newark,

T

A he problem of tubular airway reconstruction of the trachea remains formidable. Although the use of the subject's own tissue is preferable when reconstructing the tracheobronchial tree, this is impossible when a marked disparity exists between the divided ends. Although human cadaveric strudies have demonstrated than an average of 4.5 cm. of trachea can be resected and an anastomosis accomplished without undue tension,1 this cannot be relied upon in a clinical situation. Mitigating pathological factors may prevent sufficient mobilization which is necessary to unite the divergent segments. This is more crucial when it is necessary to resect the distal trachea and both stem bronchi. Consequently, it is imperative under certain circumstances to utilize a prosthesis if airway continuity is to be restored. Ideally, the graft should be airtight, have adequate consistency, be well accepted by the host, cause minimal inflammatory reaction, but still be incorporated by the surrounding tissue. In addition, it should be impervious to fibroblastic and bacterial invasion into the lumen. Finally, it should permit the ingrowth of From the Division of Cardiothoracic Surgery, New Jersey Medical School at Newark, Newark, N. J. 07107, and East Orange Veterans Administration Hospital, East Orange, N. J. Read at the Fifty-sixth Annual Meeting of The American Association For Thoracic Surgery, Los Angeles, Calif., April 23, 24, and 25, 1976.

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respiratory epithelium to traverse its inner aspect (Table I). Because these prerequisites were inherent in the synthetic polydymethyl Siloxane, a molded graft of this material was made available by Dow Corning Corp., Midland, Michigan, and evaluated in dogs initially by Graziano, Spinazolla, and Neville2 during the middle 1960's. The experimental model fulfilled all of the foregoing criteria for an ideal graft with the exception that respiratory epithelium did not traverse the inner aspect. However, this did appear to be detrimental since the nonwettable, smooth inner surface of the graft did not permit mucous encrustations or impede the expectoration of pulmonary secretions. The purpose of this paper is to present the results in 26 patients operated upon with a molded silicone prosthesis. Although complications have been observed, the over-all results have been favorable and would support our contention that this is a suitable tracheal substitute when a primary anastomosis is impossible. Materials and methods The prostheses are composed of medical-grade silicone copolymer molded under high compression and fashioned into straight and bifurcated tubes. They have an outside diameter of 0.75 to 1 inch with a length of 2.3 to 3.5 inches in the straight tube and 3.1 to 4.4 inches in the bifurcated tube. They are resilient, air525

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Table I. Ideal prosthesis 1. 2. 3. 4.

Airtight Adequate consistency Well accepted by the host Cause minimal inflammatory reaction but still be incorporated by surrounding tissue 5. Impervious to fibroblastic and bacterial invasion of the lumen 6. Permit ingrowth of respiratory epithelium along the lumen

Table II. Replacement of trachea and carina with bifurcated prosthesis in 8 patients No. of cases Pathology Adenocystic carcinoma Epidermoid carcinoma Result Early death Late death Living and well

6 2 1 2 5*

*One patient is living and well 5 years postoperatively.

Table III. Straight prosthesis for cervico-mediastinal stricture in 18 patients No. of cases Procedure Invagination (partial resection) Interposition (circumferential resection) Pathology Initial stricture Recurrent stricture Adenocystic carcinoma Epidermoid carcinoma Result Early death Late death

5 13 3 9 4 2 I* 5

*This patient died from erosion of the innominate artery.

tight, nonreactive, have a smooth inner surface, are impervious to bacteria and tissue ingrowth, and are sufficiently rigid to prevent collapse on inspiration. Their nonwetting inner surface prevents mucous encrustations and permits effective and easy clearing of distal tracheobronchial secretions. Since silicone is inert and nonporous, experience demonstrated the desirability of having the ends of the anastomosis covered with a polyester fabric to facilitate suturing the graft to the trachea and to bind it within the mediastinum by fibroblastic ingrowth into the sewing ring. The sewing rings are placed 0.5 to 1 cm. from the end in order to telescope the prosthesis into the proximal and distal airway. These rims are constructed of

thin silicone tubing wrapped in Dacron and are bonded to a recess in the graft (Fig. 1).* Twenty-six patients, ranging in age from 19 to 55 years, have had a tracheal reconstruction for benign stricture and malignancy with this molded silicone prosthesis. In 2 additional individuals the graft was inserted within the trachea to provide an airway when the obstruction was due to extrinsic pathological conditions. In 8 patients the distal trachea and carina were replaced with a bifurcated graft (Table II). Six of these individuals had distal airway obstruction from an adenocystic carcinoma which extended into both stem bronchi. In the remaining 2 patients an epidermoid carcinoma involved this segment of the tracheobronchial tree. Eighteen individuals have had the trachea reconstructed with a straight graft of silicone rubber. In 5 patients, with long nonmalignant strictures involving only a portion of the lumen, the prosthesis was invaginated into the upper and lower ends of the trachea following resection of the involved area. The remaining 13 individuals had circumferential resections of the trachea with restoration of airway continuity by endto-end anastomosis with a single graft. Nine of these patients had recurrent strictures following previous end-to-end anastomoses. In 4 individuals the pathological condition was an adenocystic carcinoma (Table III), and 2 patients had a primary epidermoid carcinoma. Surgical technique When the lesion involved the cervical trachea or when the pathology was behind the upper sternum, either a longitudinal or transverse incision was made in the neck and the sternum was divided in the midline from the manubrium to below the xiphoid cartilage (Fig. 2). The innominate artery and vein were dissected from the trachea and surrounded with umbilical tapes. The thyroid gland was divided in the midline, the lobes reflected laterally, the recurrent laryngeal nerves identified, and the trachea was mobilized from the cricoid cartilage to below the lesion. When the trachea was mobilized from the cricoid cartilage to below the lesion. When the trachea was markedly narrowed and ventilation difficult, the distal airway was transected immediately and a sterile endotracheal tube inserted. This was attached to sterile tubing and delivered to the anesthesiologist. Before the sterile endotracheal tube *Unilab, Inc., Hillside, N. J.

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Fig. 2. For lesions involving the cervico-upper mediastinal area, the neck is opened with either a transverse or perpendicular incision and the sternum is divided from the manubrium to the xiphoid.

Fig. I. The silicone prosthesis with the sewing rims placed subterminally. was inserted, it was passed through the prosthesis so that the distal anastomosis could be performed with the patient adequately ventilated (Fig. 3). The distal airway was united to the graft with interrupted 3-0 Prolene, the sutures being passed from the trachea through the sewing ring in a manner similar to that used in inserting a heart valve, and the prosthesis was then invaginated into the trachea. Another endotracheal tube was inserted orally into the graft upon removal of the initial one in the distal trachea. The proximal anastomosis was performed by passing the sutures from the sewing ring through the trachea, and the prosthesis was invaginated into the trachea (Fig. 4). The innominate artery invariably traverses the graft when a cervico-upper mediastinal reconstruction is performed. To prevent erosion of this vessel, the surgeon interposed a cuff of Dacron between it and the prosthesis. In addition, the graft was surrounded with a double-layered flap of pericardium and the surrounding tissues were utilized to cover the graft. When a portion of the tracheal wall was involved over a long segment which defied primary reconstruction, only the diseased area was excised (Fig. 5). Tracheal continuity was restored by removing the

Fig. 3. A sterile endotracheal tube is inserted through the prosthesis into the distal airway, and the anastomosis is performed with the patient adequately ventilated. Another endotracheal tube is inserted orally into the graft upon removal of the initial tube, and the proximal anastomosis is performed. sewing rings on the appropriate straight prosthesis and telescoping the graft into the proximal and distal airway. The graft was fixed to the tracheal wall with a few interrupted sutures passed superficially through the silicone tube, and covered with the surrounding tissues. For lesions involving the intrathoracic trachea or the carina or both, the right side of the chest was opened through a standard posterolateral incision (Fig. 6). The trachea was mobilized from the apex of the thorax down to and including both stem bronchi. At this point a decision was made as to whether the operation could be performed utilizing endotracheal tubes or whether cardiopulmonary bypass should be instituted. If the lesion did not involve the carina, one had the option of

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Fig. 4. Notice that the distal suture line is behind the innominate artery. To prevent erosion of this vessel, it should be wrapped with a Dacron graft and the prosthesis should be surrounded with a double-layered flap of pericardium. venous drainage was obtained by cannulating the superior and inferior venae cavae through the right atrium. Following removal of the distal trachea and carina, the bifurcated graft was anastomosed to the left stem bronchus, the right stem bronchus was united next, and finally the proximal trachea was sutured to the upper end of the prosthesis (Fig. 7). Although every effort should be made to telescope the graft into the airway, this has occasionally been impossible and an end-toend anastomosis deemed necessary. Results and complications Fig. 5. When a portion of the tracheal wall is involved, only the diseased area is excised. The prosthesis is telescoped into the proximal and distal segments. Only a few sutures are used to stabilize it.

using a sterile endotiacheal tube passed through the prosthesis into the left stem bronchi; this lung was then ventilated while the distal anastomosis was being performed. Following the distal anastomosis the original tube could be removed and another endotracheal tube passed orally into the graft for ventilation while the upper anastomosis was performed. If the carina was involved along with the distal trachea, total cardiopulmonary bypass was instituted. The femoral artery was cannulated for inflow from the pump oxygenator, and

Eight individuals had the intrathoracic trachea and carina reconstructed with a bifurcated prosthesis, and one of them died in 3 weeks. She had multiple preoperative abscesses of the right lung as a result of long-standing distal airway obstruction from an adenocystic carcinoma. Because of respiratory insufficiency she could never be weaned from the respirator even though the right lung was eventually removed in an attempt to improve pulmonary function. Two patients died 15 and 18 months following the operation from disseminated cancer. At present, 5 individuals are alive and doing well from one to 5 years following carinal replacement (Table II). In 2 of the long-term survivors, granulomas at the distal suture line were observed within the first year. These were successfully eradicated by bronchoscopic removal and fulguration. Of the 18 patients whose airway was reconstructed

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of trachea and cahna

Fig. 6. For carinal lesions, a right posterolateral thoracotomy is performed. Total cardiopulmonary bypass is used during reconstruction with a bifurcated graft.

Fig. 7. After completion of the anastomoses, the endotracheal tube is advanced into the graft and the patient supported with a volume respirator.

with a straight prosthesis, one individual died on the fourteenth day from erosion of the innominate artery (Table III). Five other individuals died from 5 months to 2 years after surgery as a result of conditions unrelated to the prosthesis. One died from a presumed cardiac arrhythmia, another died from a drug overdose, and three deaths were the result of progressive malignancy. In 5 patients, granulomas have been observed at the distal suture line, and these have been successfully eradicated with a biopsy forceps and fulguration. In one individual it was necessary to perform a right pneumonectomy because of severe bronchiectasis (Table IV). Although this condition existed prior to prosthetic reconstruction, it was exacerbated by the gradual shift of the graft to partially occlude the right stem bronchus. This might have been avoidable if Teflon pledgets had not been used to reinforce the distal anastomosis. These subsequently migrated into the lumen and partially obstructed the airway. The repetitive removal of these foreign bodies weakened the right anastomotic suture line, with resultant shift of the prosthesis to the left (Case 2).

Table IV.

Case reports CASE 1. A. H., a 49-year-old woman, was admitted to the hospital in severe respiratory distress on May 18, 1971. A biopsy of an adenocystic carcinoma had been taken at another hospital, after which her symptoms worsened. When first seen she had marked dyspnea and stridor, and she was cyanotic despite continuous administration of oxygen nasally. Since the diagnosis of adenocystic carcinoma had been substantiated and the radiograms of the chest demonstrated a stenosing lesion in the distal trachea, she was operated upon soon after admission. Adequate gas exchange was difficult to achieve after intubation, and for this reason the right side of the chest was rapidly opened through a standard

Complications No. of cases

Granuloma of distal suture line Bifurcated graft Straight graft Distal shift of prosthesis (preoperative bronchiectasis): partial obstruction of right stem; right pneumonectomy

2 5

7 1

posterolateral incision in the fourth intercostal space. After the trachea was quickly surrounded above the lesion and both the right and left stem bronchi quickly mobilized below the tumor, the patient was given heparin and the femoral artery and vein cannulated. Because a cardiac arrest seemed imminent from hypoxia, a partial perfusion was begun through the femoral vessels. The pericardium was then opened and another venous catheter was inserted into the superior vena cava from the right atrium, after which total cardiopulmonary bypass was instituted. The lesion extended up the trachea to the thoracic inlet and involved the major portion of both stem bronchi. The tumor was freely movable. Although it had extended through the wall at the bifurcation, it did not invade contiguous mediastinal structures. The trachea was transected proximal to the tumor just below the thoracic inlet, the left stem bronchus divided at the level of the upper lobe, and the right stem sectioned adjacent to its upper lobe bronchus. Airway continuity was established with a bifurcated silicone rubber graft (Fig. 8). Her convalescence was uneventful and she has remained well to the present time. CASE 2. R. P., a 19-year-old white man, sustained severe head injuries and multiple rib fractures in an automobile accident during the spring of 1974. A tracheostomy was required for acute pulmonary insufficiency. Approximately 3 months after the tracheostomy tube was removed, he noticed wheezing and stridor. Examination with a bronchoscope at another institution revealed a tracheal stenosis 3 to 4 cm. above the carina. This was dilated on several occasions with relief of the obstruction for only short periods. With no

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Fig. 8. The bifurcated prosthesis has been sutured to the left and right stem bronchi.

Fig. 9. In this patient, the stricture extended into the neck. The upper part of the airway was dilated and the prosthesis invaginated into the cervical trachea. evidence of improvement, an operation was performed at another hospital in July of 1974. An attempt by the anesthesiologist to pass the endotracheal tube into the distal trachea beyond the stricture resulted in a tear of the membranous portion from the apex of the chest to the carina. In order to widen the tracheal lumen, a pericardial flap was inserted over the membranous portion which permitted passage of an endotracheal tube into the distal trachea. For several months he was asymptomatic, but again respiratory distress developed. A bronchogram disclosed bronchiectasis of the middle and lower lobes of the right lung. Bronchoscopic examination disclosed the possibility that the posterior flap of the pericardium was not stable enough to

maintain a patent lumen during inspiration and expiration. For this reason, he was reoperated upon Dec. 16, 1974. The chest was reopened through the right thoracotomy incision and the patient placed on total cardiopulmonary bypass. When the pericardial flap was removed and the margins of the trachea trimmed, it became obvious that the stricture extended into the neck. Since a primary anastomosis could not be performed the intrathoracic trachea was resected, with a portion of the wall left intact on the left side. The narrowed segment at the thoracic inlet was dilated, and a small, straight silicone prosthesis was telescoped proximally through the strictured area (Fig. 9). The distal end was anastomosed to the trachea just above the carina. It was necessary to buttress

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Fig. 10. The prosthesis has been invaginated into the cervical trachea and sutured to the distal airway just above the carina.

Fig. 11. Notice the narrowing of the distal airway from gradual shift of the prosthesis. A right pneumonectomy was necessary because of severe bronchiectasis which antedated the graft reconstruction. the anastomosis with several mattress sutures containing Teflon felt (Fig. 10). The graft was covered with a wide pleural flap to secure it within the mediastinum. The postoperative course was uneventful despite the fact that Pseudomonas was cultured from the distal bronchi. However, he was asymptomatic when discharged from the hospital. He was readmitted in 3 months with evidence of partial airway obstruction. Bronchoscopic examination revealed that sutures containing Teflon felt pledgets were projecting into the lumen on the right lateral wall of the trachea. These were removed, with a resultant patent airway. However, several additional bronchoscopies were necessary to remove the remaining pledgets and the nonabsorbable sutures from the

distal segment. It became apparent during this time that the prosthesis had shifted slightly to the left, creating angulation of the right stem bronchus (Fig. I 1). This was not a problem until he developed pneumonia of the middle and lower lobes of the right lung from Hemophilus influenzae in January, 1975. A subsequent bronchogram disclosed extensive cylindrical bronchiectasis on the right. The distal airway easily admitted a No. 9 bronchoscope and he could effectively raise the distal secretions. However, when severe hemoptysis developed, it was felt that a right pneumonectomy was indicated. This was performed on April 5, 1976, and since then he has been asymptomatic. CASE 3. P. R., a 31-year-old drug addict, arrived in the

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Fig. 12. An example of resection of a portion of the trachea and telescoping of the graft to the cricoid and distal trachea. emergency room semicomatose on Dec. 1, 1974. An immediate tracheostomy was performed because of severe hypoxia and the inability to intubate him because of his irrational state. The incision was made from the thyroid cartilage to the suprasternal notch, and the trachea was hurriedly opened to establish an airway. He gradually recuperated but required protracted ventilatory support. After 6 weeks he was discharged from the hospital, but he returned within a short period of time complaining of wheezing and stridor. A bronchoscopic examination revealed a stricture in the midportion of the cervical trachea, the length of which was difficult to discern. He was operated upon on March 25, 1975, with the anticipation of performing a primary anastomosis. When the neck was opened, the pathological condition was found to extend beneath the sternum into the mediastinum. For this reason the sternum was divided in the midline and the trachea mobilized from the thyroid cartilage to just above the carina. Malacia of the tracheal rings over approximately 6 cm. was observed. It was obvious that a primary anastomosis could not be performed. For this reason the involved portion of the anterior tracheal wall was resected, with the normal membranous portion left. An endotracheal tube was passed through a small tracheal prosthesis into the distal airway for adequate ventilation. The prosthesis was then invaginated into the distal and proximal trachea and fixed to the tracheal wall with a few sutures. The thyroid gland and the strap muscles were placed over the prosthesis and the neck incision and median sternotomy closed in the usual manner without drainage (Fig. 12). The patient did extremely well postoperatively and was asymptomatic at the time of discharge. He was seen regularly in the clinic and at no time was there respiratory problems despite the fact that the upper end of the graft was just below the cricoid. Unfortunately, he was admitted to the hospital 5 months after prosthetic tracheal replacement with acute pulmonary edema from another drug overdose and died. Postmortem examination revealed a patent airway with absence of granulation distally and proximally (Fig. 13).

CASE 4. E. D., a 49-year-old housewife, was admitted to the hospital from another institution with severe respiratory distress. A previous diagnosis had been made of an adenocystic carcinoma obstructing the cervical and upper mediastinal trachea. She had obvious severe airway obstruction and was operated upon soon after entering the hospital. The neck was opened through a vertical incision and the sternum transected in the midline. There was a large bulky lesion in the trachea arising three rings below the thyroid cartilage and involving 5 cm. of the trachea. The airway beyond the tumor was transected and a sterile endotracheal tube placed through the prosthesis was inserted into the distal trachea for ventilation. The graft was sutured to the distal trachea with interrupted Prolene and then invaginated into the lumen over the endotracheal tube. As previously described, the sterile endotracheal tube was removed and another tube inserted orally into the prosthesis just prior to the proximal anastomosis. The innominate artery abutted the distal suture line just in front of the proximal anastomosis and it was surrounded with a Dacron graft. In addition, the suture line was covered with two layers of a viable flap of pericardium. The postoperative course was uneventful, and at the time of discharge she was asymptomatic. Discussion Despite the acknowledged superiority of using a patient's own tissue for tracheal reconstruction, there are occasions when the length of the tracheal involvement or the decrease in the elasticity of the tissue in older persons precludes the ideal method of repair. Over the years in the laboratory, a variety of prostheses have been used by various investigators. Polyethylene, 3 Vitallium, 4 stainless steel mesh, 5 homologous tracheal grafts over an acrylic tube, 6 Teflon skirted with Marlex mesh, 7 Lucite cylinders

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Fig. 13. Notice the absence of granulomas when the graft is telescoped after partial resection and sutures are not placed intraluminally. with external fixation rings,8 Ivalon sponge,9 and Marlex mesh cylinders10 have all been utilized in animals with varying degrees of success. Daniels4 reported satisfactory results using Vitallium, stainless steel, and glass. His initial observations were important, because he noted that cartilage was present around the prosthesis in the sacrificed dogs. The improbability that fibroblasts can differentiate into cartilage has recently been verified by Demos and his associates11 using a silicone prosthesis. The latter group observed that the newly formed cartilaginous rings supported the airway in one dog for 10 weeks after the prosthesis was removed. Swift and his group12 demonstrated an initial good result with a polyethylene tube; however, when they used Tantalum mesh and fascia, the equivocal result did not warrant clinical application. Meanwhile, Bucher and his associates5 reported satisfactory results when stainless steel mesh was used to construct the cervical trachea but poor results when the mesh was used intrathoracically. Davies and his associates6 showed experimentally that airway continuity could be obtained when homologous tracheal grafts were placed over an acrylic tube. Although Kramish and Marfit7 were able to obtain good airway patency using Teflon skirted with Marlex mesh, when this substance was applied to man, it collapsed and tracheal stenosis ensued. It is significant that Keshishian, Blades, and Beattie13 reported satisfactory results in animals and a few patients when only 180 degrees of the trachea was grafted with stainless steel mesh. Had this been used as a circumferential graft, the results would have been

extremely poor. Pertinent to our observations have been those of Michelson and his group,8 who showed that when Lucite cylinders were telescoped into the proximal and distal portions of the dog trachea and externally fixed with Hufnagel rings, the airway remained patent. The efficacy of invaginating the graft into the airway has also been substantiated by Borrie and Redshaw14 with the silicone prosthesis. This technique has been used to advantage in our clinical model. The advantage of a porous material, which was inert but permitted ingrowth of fibrous tissue to seal the graft, was reported by Beall and his associates10 with tubes of Marlex mesh. On the other hand Shaw, Aslami, and Webb,15 using Marlex mesh which was first implanted subcutaneously to obtain fibrocartilaginous infiltration of the inner aspect of the graft prior to insertion, observed collapse and stenosis of the trachea in all of their animals. Greenberg and Wilms16 also reported early stenosis with Marlex mesh implanted first in the omentum before transplantation to the trachea, but Poticha and Lewis17 had excellent results with a steel mesh graft lined with autogenous fibrocartilaginous tissue. Although tracheal patches with prosthetic material have been successful in a number of patients, tubular reconstruction has been sporadic. Belsey18 has been given credit for the first successful prosthetic repair of a cylindrical defect in man. He used a steel spring covered with fascia lata and left a strip of membranous trachea posteriorly to encourage epithelialization of the inner aspect. Using a similar technique, Rob and Bateman19 obtained a satisfactory result in a patient by

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using Tantalum mesh covered on both sides with fascia lata. Later, Clagett20 reported a 2 year survival in an individual in whom a polyethylene tube was inserted into the proximal and distal trachea because the tracheal defect was too extensive to patch. In the late 1940's, Jarvis21 successfully bridged a 4 cm. circumferential defect with a stainless steel tube, and Holmes22 reported an initial good result using a short Vitallium tube for an end-to-end anastomosis. Ravitch23 and later Edgerton24 reported on a number of cases from The Johns Hopkins Hospital in which Tantalum mesh and dermis were used for reconstruction. One of the most significant contributions to tubular reconstruction of the trachea was made by Cotton and Penido25 in 1952. They utilized a stainless steel tube to reconstruct almost the entire trachea in 2 patients. These individuals could raise their secretions adequately and survived for a sufficient period of time so that the efficacy of the tube could be evaluated. Later, Taber and Tomatis9 described one patient in whom an Ivalon sponge, reinforced with stainless steel springs, was utilized to establish an airway; however, the patient died on the twenty-second postoperative day from erosion of the innominate artery. On the basis of their animal experiments, Ellis and his associates26 in 1962 used a tube of Marlex mesh to reconstruct the trachea in a patient in whom the graft was invaginated into the distal trachea and brought out in the neck as a permanent tracheostomy.26 Beall,27 one of the original investigators, stated that a patient subsequently operated upon by this group is living 10 years after a tracheal reconstruction with a cylindrical tube of Marlex mesh. Pearson28 also substantiated the efficacy of this material to reconstruct the trachea when he was able to demonstrate that the entire inner aspect of the Marlex graft became epithelialized when a strip of membranous portion of the trachea remained posteriorly. His initial enthusiasm was subsequently dampened when 4 out of 7 patients died in the early postoperative period from erosion of the innominate artery by the graft. He also found it necessary to remove the Marlex mesh at the end of 5 years in another patient because of tracheal obstruction from infiltration of fibrocartilaginous material into the lumen of the prosthesis. Nonetheless, one of his patients is living and well 13 years following tracheal reconstruction with this material. Recently, Moghissi29 reported the use of Marlex mesh covered by pericardium in 13 patients who required tracheal patching or replacement. In 2 individuals, a cylindrical

The Journal of Thoracic and Cardiovascular Surgery

resection of the trachea was necessary and the defect was bridged with a tube of Marlex mesh; both are asymptomatic at the present time. Silicone rubber was evaluated because of its resiliency, tissue nonreactivity, smooth inner surface, and ability to be molded into various sizes and configurations. Since the material was nonporous and did not permit fibroblastic infiltration into the wall, it was believed mandatory to cover the anastomotic ends with Dacron, not only to expedite suturing the tube to the trachea, but more important to have a porous material which would permit the graft to be sealed within the mediastinum. Postmortem examination months later demonstrated this premise was invalid, since the entire prosthesis was firmly encased in fibrous tissue which prevented dehiscence even through the sutures had pulled through the tracheal wall. Originally, three different types of bifurcated grafts were inserted into the trachea of the dogs, with survival entirely dependent upon the consistency of the tube. In one group in which the prosthesis was soft and compressible, with a Dacron skirt at the end, several of the dogs died from empyema because of needle holes at the suture line. In the surviving animals, granulomas at the anastomotic ends were seen from invagination of the cloth into the lumen. This has also been observed in patients in whom the distal anastomosis has been wrapped with nonabsorbable material. By contrast, a semirigid prosthesis with thick rims of Dacron at the sewing edge was used in several animals, all of which were long-term survivors. Subsequently, when a similar prosthesis was inserted into sheep, Borrie and Redshaw14 observed early stenosis at the suture line. However, when the sewing rings were placed 1 cm. from the end and the prosthesis was invaginated into the tracheal stricture, granulomas were lessened. This silicone prosthesis fulfilled all of our established criteria for an ideal graft except that ciliated epithelium did not traverse the inner surface. However, in the animals and subsequently in man, the absence of adherent mucus within the prosthesis as observed through the bronchoscope or at autopsy would support our contention that a graft with a highly polished, nonwettable inner surface is superior to a prosthesis which permits fibrous tissue ingrowth into the lumen. Indeed, it has been most gratifying to observe that patients can effectively remove secretions from the distal respiratory tree across long tubular segments despite the absence of ciliated epithelium.30 Even though this is an effective airway, problems in

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patients have arisen which appear to be preventable but at the same time are annoying and perplexing. In the early model designed for clinical use, the sewing rings were constructed of a thick fabric which did not permit easy passage of a needle. As a result, they could be avulsed from the graft, with a resultant unsatisfactory anastomosis. This defect has been remedied by using a small tube of thin silicone rubber wrapped with only a few layers of Dacron mesh. Second, the occurrence of distal suture line granulomas in 6 individuals has been troublesome. This problem has principally occurred when it has been impossible to telescope the graft into the tracheal lumen and an end-to-end anastomosis has been necessary. The granulomas may result from denuding of the blood supply to the trachea, with collapse of the airway, when the prosthesis cannot be invaginated or from the formation of granulation tissue around the nonabsorbable sutures when they are inserted within the lumen. In support of both theories has been the absence of granulation tissue when only a portion of the tracheal wall is resected and the prosthesis is telescoped into the proximal and distal segments with external fixation by a few sutures. In addition, when Teflon felt is used to buttress the sutures on the membranous portion of the trachea, as we originally advocated, or is used to wrap the distal anastomosis, the material tends to migrate into the lumen creating partial obstruction. Fortunately, these problems have been successfully managed by removal with biopsy forceps and fulguration. It should be stressed that there is no danger of prosthetic dehiscence when suture-line granulomas are removed endoscopically, since the graft is firmly encased within the mediastinum within a short period of time. Fatal hemorrhage from erosion of the innominate artery, which occurred in one patient, is preventable. This is not unique to prosthetic reconstruction, since it has been observed following primary tracheal repair when the anastomosis is behind this artery. Subsequently, we have averted this catastrophe by inserting a Dacron arterial graft around the innominate artery and enveloping the anastomosis with a double flap of pericardium. The technique of resecting the innominate artery after bypassing it with a graft, as suggested by Deslauriens,31 certainly deserves consideration when there is the probablity of arterial erosion. It must be emphasized that there is no danger of fatal hemorrhage when an airway reconstruction is performed within the thorax through a right thoracotomy, because the graft is adjacent to the soft compressible superior vena cava and left atrium.

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It is important to note that graft disruption has not occurred nor has infection been a major complication. These points are significant, because it is repeatedly stated that one of the reasons why tracheal prostheses inevitably fail is that a foreign body is being inserted into a contaminated area. This has not been substantiated clinically by us or by others who have been interested in this problem. We have observed that the prosthesis is rapidly incorporated within the surrounding tissue. Unless an abscess should develop in the neck or an empyema occur within the thorax from continuous air leaks, subsequent infection should not be a problem. Thus it is essential at the time of surgery to make every effort to seal the graft within the confines of the surrounding tissue. In the neck, the thyroid and strap muscles should be approximated over the prosthesis. Within the chest, the graft should be covered with a pleural or pericardial flap. Summary A molded silicone prosthesis has been used to reconstruct the trachea in 26 patients with airway stenosis resulting from benign stricture and malignancy. In 8 individuals the distal trachea and carina were replaced with a bifurcated graft, and in 18 patients a straight prosthesis was used. In 5 of these the prosthesis was invaginated into the upper and lower ends of the trachea and fixed with a few sutures, whereas 13 individuals had primary anastomosis of the graft to the cut ends of the trachea. Despite the insertion of a foreign body into an infected area, there have been no prosthetic disruptions. Our observations suggest that this is a reasonable approach to the problem of extensive airway reconstruction.

REFERENCES 1 Mulliken, J. B., and Grillo, H. C: The Limits of Tracheal Resection With Primary Anastomosis: Further Anatomical Studies in Man, J. THORAC. CARDIOVASC. SURG. 55: 418,

1968.

2 Graziano, J. S., Spinazolla, A., and Neville, W. E.: Prosthetic Replacement of the Tracheal Carina, Ann. Thorac. Surg. 4: 421, 1967. 3 Clagett, O. T., Grindlay, J. H., and Moersch, H. J.: Resection of the Trachea: An Experimental Study and a Report of a Case, Arch. Surg. 57: 253, 1948. 4 Daniel, R. A., Jr.: The Regeneration of Defects of the Trachea and Bronchi: An Experimental Study: J. THORAC. SURG. 17: 335,

1948.

5 Bucher, R. M., Burnett, E., and Rosemond, G. P.: Experimental Reconstruction of the Tracheal and Bron-

5 3 6 Neville, Bolanowski,

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chial Defects With Stainless Steel Wire Mesh, J. THORAC. SURG. 21: 572, 1951.

6 Davies, O. G., Edmiston, J. M., and McCorkle, H. J.: The Repair of Experimental Tracheal Defects With Fresh and Preserved Homologous Tracheal Grafts, J. THORAC. SURG. 23: 367, 1952.

7 Kramish, D., and Marfit, H. M.: The Use of Teflon Prosthesis to Bridge Complete Sleeve Defects in the Human Trachea, Am. J. Surg. 106: 704, 1963. 8 Michelson, E., Solomon, R., Mann, L., and Romire, J.: Experiments in Tracheal Reconstruction, J. THORAC. CARDIOVASC. SURG. 41: 748, 1961.

9 Taber, R. E., and Tomatis, T.: Experimental and Clinical Utilization of Prostheses for Replacement of the Trachea, Arch. Surg. 77: 576, 1958. 10 Beall, A. C , Jr., Harrington, B., Usher, F. C , and Morris, G. C , Jr.: Circumferential Replacement of the Trachea With Marlex Mesh: Preliminary Report, Surg. Forum. 11: 40, 1960. 1 1 Demos, N. J., Mitnick, H., McCally, D., Feinberg, E., McKean, J., and Timmes, J. J.: Tracheal Regeneration in Long-Term Survivors With Silicone Prosthesis, Am. Thorac. Surg. 16: 293, 1973. 12 Swift, E. A., Grindlay, J. H., and Clagett, O. T.: The Repair of Tracheal Defects With Fascia and Tantalum Mesh: An Experimental Study, J. THORAC. SURG. 24: 482, 1952. 13 Keshishian, J. M., Blades, B., and Beattie, E. J., Jr.:

Dermal Grafts, J. THORAC. SURG. 21: 568, 1951.

24 Edgerton, M. T., and Zovichian, A.: Reconstruction of the Trachea and Infraglottic Larynx, Plast. Reconst. Surg. 13: 167, 1954. 25 Cotton, B. H., and Penido, J. R. J.: Resection of the Trachea for Carcinoma: Report of Two Cases, J. THORAC. SURG. 24: 231, 1952.

26 Ellis, P. R., Harrington, O. B., Beall, A. C , Jr., and De Bakey, M. E.: The Use of Heavy Marlex Mesh for Tracheal Reconstruction following resection for Malignancy, J. THORAC. CARDIOVASC. SURG. 44: 520, 1962.

27 Beall, A. C , Jr.: Personal communication. 28 Pearson, F. G., Thompson, D. W., Weissberg, H., Simpson, W. J. K., and Kergin, F. G.: Adenoid CysticCarcinoma of the Trachea. Experience With 16 Patients Managed by Tracheal Resection, Ann. Thorac. Surg. 18: 16, 1974. 29 Moghissi, K.: Tracheal Reconstruction With Prosthesis of Marlex Mesh and Pericardium, J. THORAC. CARDIOVASC. SURG. 69: 499, 1975.

30 Neville, W. E., Hamouda, F., Anderson, J., and Dwan, F. M.: Replacement of the Intrathoracic Trachea and Both Stem Bronchi With a Molded Silastic Prosthesis, J. THORAC. CARDIOVASC. SURG. 63: 569, 1972.

31 Deslauriens, J., Ginsberg, R. J., Nelems, J. M., and Pearson, F. G.: Innominate Artery Rupture: A Major Complication of Tracheal Surgery, Ann. Thorac. Surg. 20: 671, 1975.

Tracheal Reconstruction, J. THORAC. SURG. 32: 707,

1956. 14 Borrie, J., and Redshaw, N. R.: Prosthetic Tracheal

Replacement, J. THORAC. CARDIOVASC. SURG. 60: 829,

1970. 15 Shaw, R. R., Aslami, A., and Webb, W. R.: Circumferential Replacement of the Trachea in Experimental Animals, Ann. Thorac. Surg. 5: 30, 1968. 16 Greenberg, S. D., and Wilms, R. K.: Tracheal Prosthesis: An Experimental Study in Dogs, Arch. Otolaryngol. 75: 335, 1962. 17 Poticha, S. M., and Lewis, F. J.: Experimental Replacement of the Trachea, J. THORAC. CARDIOVASC. SURG. 52:

18 19 20 21

61, 1966. Belsey, R.: Resection of the Intrathoracic Trachea, Br. J. Surg. 38: 200, 1950. Rob, C. G., and Bateman, G. H.: Reconstruction of the Trachea and Cervical Esophagus: Preliminary Report, Br. J. Surg. 37: 202, 1949. Clagett, J.: Discussion of Keshishian et al. 13 Jarvis, F. J.: Discussion of Bebauer, P.: Dermal Grafts for Tracheobronchial Reconstruction, J. THORAC. SURG.

20: 649, 1950. 23 Holmes, C. L.: Discussion of Gebauer, P.: Dermal Grafts for Tracheobronchial Reconstruction, J. THORAC. SURG.

20: 650, 1950. 23 Ravitch, M.: Discussion of Gebauer, P.: Reconstructive Surgery of the Trachea and Bronchi: Late Results With

Discussion DR. HERMES C. G R I L L O Boston, Mass.

These results are indeed remarkable. Of 18 patients with straight grafts, 12 are living and well; of 8 with bifurcation grafts, 5 are living and well. Only one of the deaths was due to graft complication per se. Lest we all start inserting prostheses for repair of relatively short segments, we ought to look very carefully at the indications for such prosthetic repair. With the exception of this series and Moghissi's recent study, there has been much difficulty with tracheal prostheses in the past. In contrast to Dr. Neville's reported experience in 26 patients, during the course of the 10 years in which we have repaired 163 post-intubation strictures by direct anastomosis, I have seen only 5 or 6 patients in whom we have not attempted primary repair because of excessive extent of damage to the trachea. These lesions were all the result of inopportune prior surgery and not the result of the original stricture. It is extremely rare for an intubation stricture to be initially so extensive that it cannot be repaired primarily. Further, in 12 years, we have seen only 3 patients with malignancy of the trachea who have been potentially curable but could not be treated by primary anastomosis because of the length of the stricture. For these few patients, clearly some complex procedure such as this is in demand.

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A number of the strictures pictured by Dr. Neville we would have repaired easily by primary anastomosis. DR. W I L F O R D B. N E P T U N E Boston, Mass.

I would like to discuss this paper because I doubt if there is much experience with the use of this prosthesis. We would agree wholeheartedly that, ideally, primary repair can be done in most cases. A 65-year-old man had a left upper lobectomy in 1965 for a bronchial carcinoid and 10 years later returned with wheezing and hemoptysis. The lesion was well outlined on the plain x-ray film. In hindsight, if we had explored the neck first and had done a laryngeal release, we might have been able to do a primary repair. However, the operation was performed through a right thoracotomy. The lesion extended over a large enough area so that by the time we had adequate resection of the trachea, owing to the inability to mobilize the hilum from the previous left upper lobectomy, we could not accomplish an end-to-end anastomosis. Consequently, a Neville prosthesis was inserted and attached distally through the thoracotomy. The thoracotomy was then closed, and a proximal anastomosis was done in the neck through a separate incision. To the lesion was a tracheal carcinoid similar to the original bronchial carcinoid. The man is now doing extremely well 6 months later with an excellent airway. Although we would agree that most patients probably will not need this type of a prosthesis, it seems to work extremely well. DR. J A M E S B . D. MARK Stanford, Calif.

I would like to pay tribute to Dr. Neville for being the individual who has given this operation clinical and laboratory credibility, although many of us doubt that it has wide applicability. I agree with the discussers who indicate that this is a good bail-out procedure when it is absolutely impossible to get the ends of the trachea together. Perhaps the procedure will never challenge coronary artery bypass in applicability, but the principle is much the same. There is a very important hollow structure that is obstructed, and the obstruction must be relieved if the patient's life is to be saved. It seems that all four or five of us who are interested in this kind of operation are discussing this paper. We have recently used the Neville prosthesis in a 68-year-old man with recurrent squamous carcinoma of the trachea after two or three attempts at local excision elsewhere and then treatment with 6,000 to 7,000 rads. At operation through a median sternotomy with our resident, Dr. Jack Copeland, we resected the trachea with the carcinoma and inserted a prosthesis. We intubated the distal trachea as Dr. Neville described. We did use the pledgets. He has not coughed any up yet, but we will keep our eye out for them.

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of trachea and carina

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The prosthesis is attached and both anastomoses are wrapped very carefully with local tissue. I would like to ask Dr. Neville if these patients have had problems bringing up their secretions in early postoperative period. This was the major problem with this particular patient. D R . J O S E P H s.

MCLAUGHLIN

Baltimore, Md.

Congratulations, Dr. Neville, on an excellent paper and excellent work. At the University of Maryland, we have treated 30 patients with tracheal strictures. A few years ago, we were presented with a situation in which there were two strictures separated by 3 cm. of normal trachea. This situation had arisen before on a number of occasions, namely, a stricture in the area where a tracheostomy had been performed and a second stricture lower down near the carina, presumably due to the balloon cuff. Generally, we handled this situation by resecting the lower stricture and leaving the upper, less severe one alone. However, this particular patient had widely separated strictures both of which needed to be removed. Therefore, we resected 2 cm. of trachea just above the carina, resected another segment just below the cricoid cartilage, and performed two anastomoses. The patient did quite well and had an excellent long-term result. Being intrigued by this case, my associates and I carried out a series of experiments in dogs in which we resected increasing segments of trachea separated by a normal area of trachea. We found that we could get down to approximately 1.5 cm. of central segment and anastomose above and below this area with almost complete success, so long as we did not interfere with the blood supply coming laterally or behind the trachea. Our follow-up is too short to draw meaningful conclusions, but I believe their technique is a reasonable alternative in the case in which one does not have a prosthesis and there are two strictures widely separated. D R . N E V I L L E (Closing) I enjoyed the comments of all of the discussers. I am not here to sell this prosthesis. However, there is no question that we need one, and at the present time the silicone graft seems to be adequate. I am certain that someone in the future can come up with a better prosthesis than this model. Many substances have been utilized in the past and discarded because only an occasional case was seen by any one individual. Dr. Grillo's results without a prosthesis have been excellent. However, it cannot be denied that his patients who have permanent tracheostomies because the segments were too divergent for approximation would be better off with a prosthesis for airway continuity. Dr. Pearson treated a sizeable number of patients in the 1960's using Marlex mesh to reconstitute the airway. How-

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ever, he became disillusioned when the Marlex eroded the innominate artery in 4 individuals. In another he had to remove the Marlex mesh at a later date becuase of intraluminal obstruction caused by granulation tissue. I thank Dr. Neptune for supporting our work. It would appear that he has achieved an excellent result with the silicone prosthesis in a technically difficult situation. Dr. Mark asked about secretions in the early postoperative period. This has not been a major problem with us. We leave

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the endotracheal tube in the prosthesis and keep the patients intermittently on a respirator for a few days. By this maneuver we can more adequately suction the tracheobronchial tree, since all of the patients have some degree of pooled secretions preoperatively from tracheal obstruction. Dr. McLaughlin's comments were much appreciated. I know that he will continue to utilize his expertise in this very difficult area of tracheobronchial reconstruction.