Outcomes Following Pharyngolaryngectomy With Fasciocutaneous Free Flap Reconstruction and Salivary Bypass Tube
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1 The Laryngoscope VC 2012 The American Laryngological, Rhinological and Otological Society, Inc. Outcomes Following Pharyngolaryngectomy With Fasciocutaneous Free Flap Reconstruction and Salivary Bypass Tube Fernando Lopez, MD, PhD; Sergio Obeso, MD; Daniel Camporro, MD, PhD; Ángel Fueyo, MD; Carlos Suarez, MD, PhD; Jose L. Llorente, MD, PhD Objectives/Hypothesis: Reconstruction of the pharyngoesophageal defects is one of the most challenging for head and neck surgeons. We evaluated our experience in the hypopharyngeal reconstruction using a fasciocutaneous free flap in conjunction with a Montgomery salivary bypass tube (MSBT). Study design: Retrospective review. Methods: The charts of 55 patients who had undergone hypopharynx reconstruction using either a radial forearm free flap (RFFF) (24) or an anterolateral thigh (ALT) flap (31) with MSBT were reviewed. There were 40 circumferential and 15 near-circumferential defects. Outcomes analyzed included fistula and stricture rates and swallowing function. Results: Pharyngocutaneous fistula occurred in 9% of patients (16% using RFFF and 3% using ALT), and strictures occurred in 5% (8% using RFFF and 3% using ALT). Of patients reconstructed with this technique, 95% were able to resume oral alimentation. Conclusions: The use of fasciocutaneous free flaps in conjunction with the MSBT is a useful tool for pharyngoesophageal reconstruction. Key Words: Fasciocutaneous free flap, salivary bypass tube, hypopharyngeal reconstruction, radial forearm free flap, anterolateral thigh flap. Level of Evidence: 4. Laryngoscope, 123: , 2013 INTRODUCTION Reconstruction of pharyngoesophageal defects following resection of a laryngopharyngeal tumor remains a challenging procedure in the head and neck surgeon practice. Currently, the main options include free jejunal transposition, radial forearm free flap (RFFF), and anterolateral thigh (ALT) free flap. Other techniques, such as pectoralis major myocutaneous flap (PMMF), deltopectoral flap, and gastric pull-up, should be considered a second-choice reconstructive option. All of these procedures have the ability to reestablish continuity of the upper aerodigestive system, and they carry with them varying rates of fistula and stricture, success with swallowing rehabilitation, and acquisition of laryngeal speech. Visceral free grafts offer an unparalleled amount of highly vascularized tissue to manage the difficult situation of pharyngoesophageal reconstruction. And, although complication rates remain not negligible, 1 they From the Department of Otorhinolaryngology and Head and Neck Surgery (F.L., S.O.,C.S., J.L.L.), Instituto Universitario de Oncología del Principado de Asturias; and Department of Plastic Surgery (D.C., A.F.), Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain. Editor s Note: This Manuscript was accepted for publication August 2, The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Fernando Lopez Álvarez, c/o Marcos Pe~na Royo, 20 4 A, Oviedo Asturias, Spain. flopez_1981@yahoo.es DOI: /lary have relatively low rates of pharyngocutaneous fistula (PCF) and stricture. Fasciocutaneous free flaps (FFF) as RFFF 2 and ALT 3 are currently being used more frequently than visceral free flaps because of reliability, technical accessibility, and popularity with surgeons. Functional outcomes have been reported to be better with modern FFF reconstruction compared with the traditional jejunum flap, and the donor morbidity is reported as minimal ALT flaps are associated with low rates of PCF and strictures, and a lower rate of donor morbidity than jejunal and RFFF flaps, which makes this option progressively more popular. In order to improve outcomes after pharyngoesophageal reconstruction, several modifications were introduced. 9 The use of a salivary bypass tube in combination with a PMMF has been reported with moderate PCF rates Since the last decade, encouraged by the good results of the reported experiences in pharyngeal reconstructions, 24,25 we used a Montgomery Salivary Bypass Tube (MSBT) (Boston Medical Products, Inc., Westborough, MA EEUU) to stent the FFF reconstruction. This study evaluates the outcome of pharyngoesophageal reconstruction using FFF in conjunction with an MSBT. MATERIALS AND METHODS From January 2000 to January 2010, a retrospective chart review identified 55 patients in whom pharyngoesophageal reconstruction following laryngopharyngectomy was performed 591
2 Fig. 1. (A) The anterolateral thigh flap is raised with a rhomboid skin paddle and based on the cutaneous perforators. (B) A typical circumferential pharyngoesophageal defect that extends from the base of the tongue to the cervical esophagus above the sternal notch. A salivary bypass tube is placed, with the upper flange at the base of tongue and the distal portion advanced through the lumen of the cervical esophagus. (C) The anterolateral thigh flap is sutured in a horseshoe shaped to the prevertebral fascia, using the salivary bypass as a stent for the reconstruction. (D) The flap is tubed and inset in the defect. The fascial layer is used to reinforce the suture lines to minimize the risk of fistula formation. The pharyngeal closure is completed. in our department using a FFF (RFFF or ALT) in conjunction with a MSBT. Patients were judged to be candidates for FFF reconstruction in conjunction with a MSBT when the pharyngeal defect was circumferential, or when the width of the remaining pharyngeal mucosa was less than 2 cm. Data on surgical details, surgical and medical complications, donor site morbidity, flap failures, swallowing, hospital stay, adjuvant therapy, and overall survival were collected from medicals reports. Patients There were 51 male and four female patients, with a mean age of 59 years (range, years). Pathology included primary squamous cell carcinomas (SCC) (T3 and T4) in 15 patients (27%), recurrent SCC in 17 patients (31%), second primary SCC in six patients (11%), and PCF after previous laryngectomy in 17 patients (31%). All 40 patients (73%) with recurrent or secondary primary carcinomas or PCF had received prior radiotherapy. Four patients (7%) had received prior concurrent chemotherapy. Thirty-five patients (64%) had undergone prior total laryngectomy with bilateral neck dissection, and 16 patients (29%) had received prior pedicled PMMF reconstruction. Forty-nine patients (89%) were smokers and 33 (60%) were alcohol abusers. Major comorbidities included arterial hypertension (39%) and coronary artery disease (22%). The average body mass index was 24, 9 6 3, 9 (range, 17 to 40). The mean preoperative haemoglobin level were 13, 9 6 1, 6 g/dl (range, 10, 1 to 14, 6). Selection between RFFF and ALT generally was based on the size and nature of the defect after cancer ablation. It also depended on the available adipose tissue volume, as judged by examination of the patient s body habitus and familiarity with a specific flap by a surgeon. Under these conditions, RFFF were used for reconstruction of pharyngoesophageal defects in 24 patients and ALT were used in 31 patients. Surgical Technique (Fig. 1) A two-team approach was used in all cases. The ALT and RFFF were designed and harvested as previously described. 10,11,18,26 The length of the reconstruction was decided by the resection, but generally was around 10 cm. The mean size of the flaps was 48 cm. 3 The skin island was rectangular in 43 patients (78%) and trapezoidal in 12 patients (22%). In cases where concomitant outer neck skin reconstruction was 592
3 TABLE I. Type of the Surgery Performed with Reconstruction. Primary squamous 10 TPL and 5 SP þ TL cell carcinoma Recurrent squamous cell carcinoma Second primary squamous cell carcinoma Pharyngocutaneous fistula 12 TP and 5 TPL (12 cases had previous TL) 6TP (all cases had previous TL) 7 TP and 10 SP (all cases had previous TL) SP: subtotal pharyngectomy; SP þ TL: subtotal pharyngectomy plus total laryngectomy; TP: total pharyngectomy; TPL: total pharyngolaryngectomy. necessary, a separate skin island or a skin grafting on the underlying fascia was used. All procedures were carried out using the same technique. The lateral edges of the flap were sutured to the prevertebral fascia in a horseshoe shape. The portion of the reconstruction constituting the posterior pharyngeal wall was allowed to mucosalize over the exposed prevertebral fascia, resulting in the gain of an extra few centimeters in diameter. The flap was sutured using a two-layer closure, with the fascia wrapped around the tube to reinforce the suture lines. When the goal was to repair a PCF, the closure was performed in a patch fashion. All patients underwent placement of a MBST intraoperatively. After suturing one edge of the flap to the prevertebral fascia or to the pharyngeal remnant, the MBST is placed with the upper flange at the base of tongue and the distal portion advanced through the reconstruction segment past the inferior anastomotic line. MSBT is kept in correct position by means of a 16F red rubber catheter, which is sutured to the upper portion of the bypass tube and subsequently anchored to the anterior nasal septum. Subsequently, the other edge of the flap is sutured to the prevertebral fascia or pharyngeal remnant around the MSBT. To avoid accidentally pulling out the feeding tube when the bypass is removed, it is placed outside the bypass. Recipient arteries included the superior thyroid artery in 17 cases, the facial artery in 16 cases, the lingual artery in nine cases, the transverse cervical artery in seven cases, the external carotid artery in four cases, and the superficial temporal artery in two cases. Recipient veins included the external jugular vein in 35 patients, the internal jugular vein in six cases, the common facial vein trunk in 10 cases and the transversal cervical vein in four cases. All ALT donor sites were closed primarily, and the RFFF donor sites were closed either with skin grafted or by means of an ulnar flap as previously described. 27 In all patients, tube feeding was started on postoperative day 1 and continued for 2 weeks, at which point a modified barium swallow study was performed after MSBT removal. The bypass tube was removed by pulling on the catheter to which it was attached. If no leaks were detected, oral intake was started to assess the patency and competency of reconstruction. For patients who manifested delayed healing or a fistula on day 14, the removal of the MSBT was delayed until improved wound healing. Statistical Analysis Data were expressed as mean values 6 standard deviation. Fisher s exact test was used for comparison. Survival curves were calculated by the Kaplan-Meier method and the comparison between subgroups was performed by Log Rank TABLE II. Flap Type According to the Defect Characteristics. Radial Forearm Free Flap (n ¼ 24) Anterolateral Thigh Free Flap (n ¼ 31) Total Total pharyngolaryngectomy Total pharyngectomy Subtotal pharyngectomy Subtotal pharyngectomy plus total laryngectomy test. A P values of < 0.05 was considered statistically significant. All calculations were performed using SPSS 15.0 for Windows. RESULTS A total pharyngectomy was performed in 25 patients (46%), a total pharyngolaryngectomy in 15 patients (27%), a subtotal pharyngectomy in 10 patients (18%) and a subtotal pharyngectomy with total laryngectomy in five patients (9%) (Table I). Finally, all patients were laryngectomized. In summary, there were 40 (73%) circumferential and 15 (27%) near-circumferential (<2- cm wide strip of mucosa left) defects. Partial resection of the base of the tongue was required in six patients, and 16 patients underwent simultaneous neck dissection. Concomitant neck resurfacing reconstruction was performed in 16 patients (29%) with a skin grafting. Table II shows the flap type used according to the defect characteristics. There were no operative deaths. Mean intensive care unit stay was 2, 6 6 1, 6 days (range, 0 5 days) and the mean hospital stay was days (range, days). The hospital stay was longer in patients who developed a PCF in the postoperative period ( vs days, P ¼ 0,020). All flaps survived. Ten patients (18%) had complications (Table III). Proximal migration of the MSBT appeared in seven patients (12%). In all but two cases, TABLE III. Overall Incidence of Complications. Complications No. of Patients Recipient site Neck infection 2 (4%) Hematoma 6 (11%) Delayed wound healing 2 (4%) Fistula 5 (9%) Stricture 3 (5%) Proximal migration of the bypass 7 (12%) Donor site Wound infection 4 (8%)* Other complications Pneumonia 2 (4%) Acute renal failure 1 (2%) *All cases corresponded to radial forearm free flap donor sites. There no was donor site morbidity after sacrificing anterolateral thigh flap. 593
4 TABLE IV. Incidence of Fistula and Stricture in Patients According to Pharyngeal Defect and Used Flap. Radial Forearm Free Flap Anterolateral Thigh Free Flap Circumferential Partial Circumferential Partial Prior radiotherapy 9 (90%) 8 (57%) 8 (53%) 15 (93%) 40 (73%) Postoperative radiotherapy 1 (10%) 5 (35%) 5 (33%) 1 (7%) 12 (21%) Fistula 2 (20%) 2 (14%) 1 (7%) 0 5 (9%) Stricture 2 (20%) 0 1 (7%) 0 3 (5%) Total the MSBT was easily repositioned in the hospitalization room. Distal migration of the MSBT was observed in no patient. The MSBT was well tolerated in all patients, although it requires a higher level of analgesia (minor opiates). The number of postoperative days before removal of the MSBT and initiation of oral alimentation ranged from 9 to 30 days, with a mean of 18 days. Five patients (9%) developed a PCF daysafter surgery (range, 6 24 days). Four patients had undergone a pharyngeal reconstruction throughout a RFFF (16% of all RFFF) and one through an ALT (3% of all ALT). Two of them (in which had been used a RFFF) developed large proximal fistulas and were repaired by means of a PMMF. One fistula (in which had been used an ALT) was repaired using a deltopectoral flap, and two were healed by secondary intention. The incidence of PCF was higher in circumferential (3 cases) than in nearcircumferential pharyngoesophageal defects (2 cases) (Table IV). The group of patients who developed PCF had a lower preoperative hemoglobin level than those without fistula (12, 7 6 1,6 g/dl vs. 14, 4 6 1, 1 g/dl; P ¼ 0.027). Anastomotic stricture occurred in two RFFF patients (8%) and in one ALT patient (3%). All patients responded to repeated endoscopic balloon dilatation (Table IV). There were no significant differences in the incidences of fistula and stricture formation between patients with or without a history of radiotherapy (Table V). Swallowing function was determined by the type of diet the patients tolerated (normal/soft or tube-feeding dependent). 19 In those patients for whom the swallowing of normal/soft diet was difficult after a 3 and 6 months reintroduction of oral feedings, a gastrografin esophagram (followed by a barium esophagram if no leak was seen) was performed to assess stenosis or PCF. Finally, 30 patients (55%) had a normal diet, 22 (40%) tolerated a soft diet, and three (5%) received alimentation by way of a feeding tube. In the latter, reconstruction was performed using a RFFF (P ¼ 0.002) and the defect was circumferential. Follow-up of patients enrolled in the study ranged from 6 months to 10 years, with a mean of 27 months. Postoperative radiotherapy was administered to 12 patients. At the end of the follow-up period, 17 patients (31%) were alive without evidence of disease, 31 patients (56%) died due to the disease, and seven patients (13%) died due to unrelated causes. The 1-year, 3-year, and 5- year survival rates according to the Kaplan-Meier method for all 55 patients were 56%, 38%, and 25%, respectively. No significant difference was observed in survival between pharyngeal reconstruction with RFFF or ALT flap. DISCUSSION Since (chemo) radiotherapy became the primary treatment for most laryngeal and hypopharyngeal carcinomas, surgery usually has been reserved for late-stage as well as residual and recurrent disease. In such cases, primary closure of the pharynx may not possible, or may carry a high risk for PCF. Poor long prognosis in these patients requires a reliable one-stage reconstruction of pharyngoesophageal defects with good functional outcomes. Traditionally, pharyngoesophageal reconstruction was performed with pedicled flaps or enteric free flaps with acceptable results. 28 However, specific complications with all these techniques forced surgeons to look for other alternatives. Many FFF have been described, but the most commonly used flaps are RFFF and ALT. 29 Both flaps are distant to the resection site, and therefore not in the zone of radiotherapy, and have good functional outcomes. However, ALT are more suitable for larger defects and have limited impacts to the donor site. 30 Nowadays our reconstructive choice is the ALT. It provides a reliable and functional single stage reconstruction of pharyngoesophageal defects with minimal morbidity. If the thigh is thick or cervical defect is small, the RFFF is our reconstructive option. Since 2000, we have introduced the use of MSBT in conjunction with the FFF for reconstruction of the circumferential or near-circumferential pharyngoesophageal defects. Salivary bypass tubes were first used to divert salivary flow in patients who developed fistulae. 31,32 Varvares et al. 25 and Murray et al. 24 describe the use of free flap in conjunction with the MSBT. Varvares et al. used the MSBT in conjunction with the RFFF and Murray et al. with the ALT. Unlike our placement method TABLE V. Effects of Radiotherapy on Fistula and Stricture Formation. Prior Radiotherapy Postoperative Radiotherapy Yes No Yes No Fistula 3/40 2/15 N/A N/A Stricture 0/40 0/15 2/12 (16%) 1/43 (2%) N/A: not applicable. 594
5 explained above, Varvares et al. place the MSBT after the pharyngeal closure and Murray et al. wrap the flap around a MSBT before suturing the flap. We think that our method facilitates the placement of the tube and suturing of the flap. Distal migration of the MSBT into the stomach is a rare event that requires endoscopic extraction when it occurs. This easily may be prevented with our method of placement. We think that minimizing the exposure of the anastomotic suture line to saliva and stenting the reconstruction during the early healing phase reduces the incidence of fistulae, anastomotic leaks, and strictures. According to Murray et al., 9 a PCF is defined as a cutaneous or body cavity communication. The overall fistula and stricture rate for this series of patients was 9%, all occurring early in the series. The RFFF has a reputation for having a high fistula rate, ranging from 17% to 50%, which is higher than the rate found in our series (16%). 5 Our series with the ALT shows a fistula rate of 3%, which is slightly lower than that reported in the literature (9%) and comparable to that with the jejunal flap. 1,16 Varvares et al., 25 with RFFF in conjunction with MSBT, showed a fistula rate of 20%. This result is similar to ours (16%), but in their series there were a lower percentage of patients with active neoplastic disease, and there were a lack of data about previous radiotherapy. No patients in the series reported by Murray et al. 24 developed PCF using an ALT with a MSBT. This series encompassed a low number of patients but showed excellent outcomes, which were similar to those obtained in our study. These good results compare favorably with other reports, 9 and this lack of fistula development may be attributed either to the combination of the MSBT or to the closure with the second layer available in the ALT. There is agreement that the initial management of fistulae should be conservative as in most cases they close spontaneously. In our series, 40% of patients (2 of 5 fistulae) evolved favorably with local care and tube feeding, a figure that coincides with the published data. 33 In those cases where the fistula persists, the use of a PMMF is a valid and feasible option. There is no total consensus on the factors that predispose toward dehiscence of the pharyngeal suture line. Local factors and systemic factors are mentioned in the literature. 34 We found a higher rate of fistula formation in patients with a preoperative hemoglobin level lower or higher than 12 mg/dl (OR ¼ 4, 7; P ¼ 0,029). These data support the findings of Paydarfar et al., who in a systematic review found that a hemoglobin level lower than 12, 5 mg/dl is a risk factor to develop fistula after total laryngectomy. 35 It is well-known that prior radiotherapy is a risk factor to suffer postlaryngectomy fistula. 36 Nevertheless, some authors failed to relate previous radiotherapy and fistula formation in pharyngoesophageal reconstruction. 2 In our series, there were no significant differences in the incidence of fistulas or stenosis among patients with or without a history of radiotherapy. We believe that using a FFF in conjunction with a MSBP is a safe tool for reconstruction following major pharyngolaryngeal surgery and radiotherapy. Stricture formation at the distal anastomosis is another common complication. Reported rates of stricture formation after RFFF reconstruction vary from 5% to 40%, 10 and after jejunal flap reconstruction they range from 15% to 22%. 1 In our series, with RFFF the strictures developed in 8% of patients and with ALT they developed in 3%, all in patients with a circumferential defect. Stricture formation is most likely the result of circular scar contracture in circumferential reconstructions. Spatulation of the distal anastomosis and a suture facilitated by MSBT may decrease the risk of strictures in circumferential reconstructions. In contrast to Murray et al., 24 we prefered to delay the beginning of the oral intake until the MSBT was removed. The percentage of feeding tube dependence (5%) was slightly inferior to that previously reported in hypopharyngeal reconstructions throughout FFF 9 and when the MSBT was used (15 and 20%). 24,25 Our series shows a rate of patients who tolerated a normal diet of 47%, which is comparable to that reported by Varvares et al. 25 CONCLUSION The use of FFF (especially ALT) in conjunction with the MSBT is a useful tool for pharyngoesophageal reconstruction. We believe that MSBT can be useful to stent the reconstruction, calibrate the new digestive tract, and decrease salivary exposure of the anastomotic suture line. Consequently, the pharyngoesophageal reconstruction rapidly heals and the rate of fistula and stricture decreases. With this series of patients, we have shown a satisfactory functional outcome and a lower PCF rate than those previously published. Although our data offers some encouragement for this approach, the precise value of MSBT has to be proved in prospective randomized studies. BIBLIOGRAPHY 1. Reece GP, Schusterman MA, Miller MJ, et al. Morbidity and functional outcome of free jejunal transfer reconstruction for circumferenctial defects of the pharynx and cervical esophagus. Plast Reconstr Surg 1995;96: Harii K, Ebihara S, Ono I, Saito H, Terui S, Takato T. Pharyngoesophageal reconstruction using a fabricated forearm free flap. Plast Reconstr Surg 1985;75: Song YG, Chen GZ, Song YL. The free thigh flap: a new free flap concept based on the septocutaneous artery. Br J Plast Surg 1984;37: Andrades P, Pehler SF, Baranano CF, Magnuson JS, Carroll WR, Rosenthal EL. Fistula analysis after radial forearm free flap reconstruction of hypopharyngeal defects. Laryngoscope 2008;118: Anthony JP, Singer MI, Deschler DG, Dougherty ET, Reed CG, Kaplan MJ. 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