Transoral Robotic Surgery for Upper Airway Pathology in the Pediatric Population

Transcription

1 The Laryngoscope VC 2016 The American Laryngological, Rhinological and Otological Society, Inc. Transoral Robotic Surgery for Upper Airway Pathology in the Pediatric Population Carlton J. Zdanski, MD; Grace K. Austin, MD; Jonathan M. Walsh, MD; Amelia F. Drake, MD; Austin S. Rose, MD; Trevor G. Hackman, MD; Adam M. Zanation, MD Objectives/Hypothesis: The purpose of this study is to present one of the largest case series of pediatric transoral robotic surgery (TORS) in the upper airway demonstrating a wide range of ages and indications. Study Design: A retrospective case series at an academic tertiary referral center from August 2010 to September Methods: The da Vinci surgical robot (Intuitive Surgical, Inc., Sunnyvale, CA) was used on 16 pediatric patients for 18 procedures. A variety of upper airway pathologies and reconstructions in children with a wide range of ages and weights were treated. No lingual tonsillectomies or base-of-tongue reductions were included. Results: Sixteen children (6 males) underwent 18 TORS procedures, including resection of hamartoma (n 5 1), repair of laryngeal cleft (n 5 7), removal of saccular cyst (n 5 2), release of pharyngeal or esophageal strictures (n 5 2), and excision of lymphatic malformations (n 5 4). Patient ages ranged from 14 days to 15 years. There were no intraoperative complications. All patients had successful robotic access, and no patients had conversions to open or traditional endoscopic surgery. Hospital courses varied with duration ranging from 1 to 20 days. The median follow up was 22 months. Conclusion: Applying TORS to the pediatric population can be feasible and safe for appropriate airway pathologies. Because many patients are small in size, there is inherent risk in using robotic instruments and scopes transorally. Pearls in this series include a standardized two-robot experienced attending team and longitudinal airway follow-up. Key Words: Laryngeal cleft, saccular cyst, lymphatic malformation, pediatric airway, transoral robotic surgery (TORS). Level of Evidence: 4 Laryngoscope, 127: , 2017 INTRODUCTION Transoral robotic surgery (TORS) for use in the pediatric airway is a recent application of this technology. Within a few years of descriptions of TORS in adults for head and neck surgery, animal studies investigating the feasibility of pediatric applications were published. 1 It was first described in human pediatric patients by Rahbar et al. with a case series of five patients in Since that time, there have been seven case reports and case series presented in the literature; the largest describes 16 patients who underwent lingual tonsillectomy. 3 9 The role of TORS in the pediatric airway is still evolving. As the technology and tools advance, the indications and applications of TORS in the pediatric airway From the Department of Otolaryngology/Head and Neck Surgery, University of North Carolina Hospitals (C.J.Z., G.K.A., A.F.D., A.S.R., T.G.H., A.M.Z.), Chapel Hill, North Carolina; and the Department of Otolaryngology/Head and Neck Surgery, Johns Hopkins University (J.M.W.), Baltimore, Maryland, U.S.A. Editor s Note: This Manuscript was accepted for publication April 25, This work was supported by a grant for the National Institute on Deafness and other Communicative Disorders, T32DC (G.K.A.). The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Carlton J. Zdanski, MD, Associate Professor, Department of Otolaryngology/Head and Neck Surgery, University of North Carolina, 170 Manning Drive, CB 7070, Physician s Office Building, Room G-190, Chapel Hill, NC carlton_zdanski@med.unc.edu DOI: /lary are being developed. We present one of the largest case series of pediatric TORS, detailing our experience with a wide range of patient ages and pathologic processes. The purpose of this report is to illustrate the potential and feasibility of TORS in the pediatric airway and complex reconstructions. MATERIALS AND METHODS The da Vinci surgical robot (Intuitive Surgical, Inc., Sunnyvale, CA) was used on 16 pediatric patients for 18 procedures at the University of North Carolina, Chapel Hill, North Carolina, from August 2010 to September Patients with pharyngeal and laryngeal pathology requiring either endoscopic or open surgical treatment were offered TORS as an alternative treatment option. For vascular malformations, this was limited to lymphangiomas for this series. Arteriovenous malformations, venous malformations, and other vascular tumors were excluded from consideration. The da Vinci surgical robot has been U.S. Food and Drug Administration-approved for resection of T1 and T2 oropharyngeal cancers. We applied robotic technology for off-label use in pediatric airway procedures. Patients and families were offered traditional approaches and were also informed of the off-label application of TORS. All consent forms clearly stated that the robot would be utilized. The procedures were also preauthorized for insurance coverage. There are special considerations of the pediatric procedures. Because many patients are small in size, there is inherent higher risk in introducing and manipulating robotic instruments and scopes transorally compared to adult patients. 247

2 as well as residents and fellows, have access to a robotic simulator and are at the console with simulation prior to participating in robotic surgery cases in general. However, the surgeons did not practice on a robot simulator for each patient immediately prior to surgery. Two experienced robot-credentialed attending surgeons alternated positions between the robot console (i.e., the robotic surgeon) and the bedside (i.e., the bedside surgeon), as needed. A bedside surgeon participated in every case, utilizing a variety of standard laryngeal and pharyngeal surgical instruments including suction and cautery (Fig. 2). In addition, the bedside surgeon had the critical role of protecting the patient and maintaining the airway during the procedure. Fig. 1. Positioning of the robot and the patient. [Color figure can be viewed in the online issue, which is available at The operating room setup was similar to adult patients. All patients were placed in the supine position with the table top 180 degrees from the normal position; that is, the patient s head was placed at the foot of the bed. This allows for placement of the robot to be placed underneath the table and closer to the patient after rotating the bed (Fig. 1). The patients were induced by pediatric anesthesiologists, the airway was topically anesthetized with lidocaine, and the operating table was then rotated 90 degrees away from the anesthesiologist s field to deliver the patients toward the surgeon. The operating table is rotated a total of 90 degrees. Direct laryngoscopy and bronchoscopy were performed prior to each procedure under the same anesthetic. When patients had existing tracheostomy tubes, these were replaced with laser-safe Jackson tracheostomy tubes for the duration of the procedure. In patients without tracheostomies, an appropriate laser-safe endotracheal tube (i.e., cuffless Mallinckrodt laser oral endotracheal tube, Magill tip; Covidien plc, Dublin, Ireland) was sized and placed when feasible. A tooth guard was individually created and placed when teeth were present utilizing Aquaplast (Medline, Mundelein, IL). A variety of mouth gags were available for selecting appropriate fit. We found that a McIvor gag with a flat blade produced the best exposure of the posterior larynx for laryngeal cleft repair in most patients. A tongue stitch was utilized for retraction when a mouth gag was not necessary. The articulating robotic arms were positioned intraorally with camera, typically utilizing a 30-degree anterior facing scope for hypopharyngeal and laryngeal pathology and a 0- degree scope for tongue base pathology. In all cases, 5-mm working ports and instruments were used. There were two attending surgeons that were robotcredentialed during these cases. There is an internal hospital pathway for robotic surgery credentialing. Attending surgeons, RESULTS Sixteen children (6 males) underwent 18 TORS procedures including resection of hamartoma (base of tongue) (n 5 1), repair of laryngeal cleft (n 5 7) (Fig. 3), removal of saccular cyst (n 5 2), release of pharyngeal or esophageal strictures (n 5 2), and excision of lymphatic malformations in the base of tongue (n 5 1) or hypopharynx/supraglottis (n 5 3) (Table I). Of the patients with lymphatic malformations, two patients received subsequent TORS procedures. Patients with lingual tonsillectomies or tongue base reductions were not included. The median follow-up from surgery was 22 months (range, 56 days to 44 months). At the time of surgery, the median age of children was 4 years old (range, 14 days to 15 years). The median weight was 18.4 kg (range, 2.5 kg to 93.7 kg). The youngest patient was 14 days old and weighed 3.7 kg. The smallest patient was 26 days old and weighed 2.5 kg. Both had saccular cysts and successfully underwent robotic-assisted removal of these lesions (Fig. 4). The median operating room (OR) elapsed time (time from patient entering the OR room to exiting the OR room, including time of anesthesia care and robot setup) was 3 hours, 17 minutes (range: 2 hours, 27 minutes to 5 hours, 37 minutes). The median surgery elapsed time (time for surgical procedure including laryngoscopy and bronchoscopy) was 2 hours and 24 minutes (range: 1 hour, 3 minutes to 4 hours, 38 minutes). The median setup time (patient release from anesthesia team to time out) was 8 minutes. The docking time, that is, the time used to position the robot, could not be determined or calculated from the retrospective review of the data. Fig. 2. The bedside surgeon utilizes standard laryngeal and pharyngeal surgical instruments, as well as having the critical role of protecting the patient and the airway. [Color figure can be viewed in the online issue, which is available at 248

3 Fig. 3. Laryngeal cleft repair. (A) Palpation of the laryngeal cleft prior to repair; (B) close-up intraoperative view of the laryngeal cleft closure during repair; (C) intraoperative view of the luminal side of laryngeal cleft after repair. [Color figure can be viewed in the online issue, which is available at There were no intraoperative complications. The overall TORS completion rate was 100%. No procedures were converted to open or traditional endoscopic surgery. Estimated blood loss ranged from 0 to 25 ml. The majority of patients had high-grade American Society of Anesthesiologists (ASA) classification: ASA I (n 5 2), ASA 2 (n 5 1), ASA 3 (n 5 7), and ASA 4 (n 5 6) (Table I). The reason many patients in this series had a high-grade ASA classification is related to their complex medical conditions, but ASA grade was not a criterion for eligibility. Three of 16 patients had a tracheostomy tube in place prior to the operative case. None of the patients required a new tracheostomy intraoperatively or postoperatively. Five patients were kept intubated after the procedure and were observed in the pediatric intensive care unit (PICU) (1 4 days) for protection of the airway. There were three postoperative complications. The first patient was a 5-year old girl, ASA 3, who had a type 1 laryngeal cleft and sleep-disordered breathing (patient 8). On polysomnogram, the patient had an apnea-hypopnea index of 0.3 (no obstructive apneas, 2 central apneas, and 2 hypopneas). The patient was not treated surgically for the sleep-disordered breathing. The patient underwent a TORS-assisted laryngeal cleft repair and removal of supraglottic tissue using CO2 laser with FlexGuide ULTRA conduit (Omniguide, Lexington, MA). The patient had no intraoperative complications, but required immediate reintubation in the operating room at the end of the case due to copious secretions. The patient was extubated successfully in the PICU and discharged home on postoperative day 5. The second patient was a 12-year-old girl who had a history of caustic ingestion and resultant pharyngeal, supraglottic, and esophageal strictures (patient 12). The patient had an existent tracheostomy tube in place and underwent multiple previous procedures addressing strictures at the oral aperture, hypopharynx, and esophagus. The patient underwent a TORS approach that included pharyngectomy, supraglottic laryngectomy, and base-of-tongue release. The surgical wound site was allowed to heal by granulation. The patient had no intraoperative complications but had poor tidal volumes after surgery. Despite perioperative antibiotics, the TABLE I. Patient Characteristics. Patient Gender Weight (kg) ASA Indication 1 F Supraglottic lymphatic malformation 2 F 44 3 Hypopharyngeal and supraglottic lymphatic malformation 3 F 10 3 Type I laryngeal cleft 4 M 30 1 Pharyngeal and esophageal stricture 5 M 3.7 4E Saccular cyst 6 M Type II laryngeal cleft 7 F Type I laryngeal cleft 8 F Type I laryngeal cleft 9 M Saccular cyst 10 F Base of tongue hamartoma 11 F Hypopharyngeal lymphatic malformation 12 F Pharyngeal and esophageal stricture 13 M 8 3 Type III laryngeal cleft 14 M Type II laryngeal cleft 15 F Base of tongue lymphatic malformation 16 F Type I laryngeal cleft ASA 5 American Society of Anesthesiologists; F 5 female; M 5 male. 249

4 Fig. 4. Saccular cyst excision. (A) Visualization of the saccular cyst prior to excision; (B) intraoperative view after excision of saccular cyst. [Color figure can be viewed in the online issue, which is available at patient developed pneumonia and septic shock postoperatively that required broad-spectrum antibiotics and vasopressors. The patient underwent emergent bronchoscopy on postoperative day 2 for respiratory distress and copious secretions. The patient was found to have worsening right middle-lobe consolidation. By postoperative day 7, the patient was successfully weaned to tracheostomy collar and discharged home on postoperative day 8. The third patient was a 3-year-old girl, ASA 4, with DiGeorge syndrome and subglottic stenosis who underwent repair of type 1 laryngeal cleft and excision of redundant glottic tissue (patient 16). The patient was kept intubated postoperatively but failed extubation under steroid coverage on postoperative day 3. The patient was successfully extubated on postoperative day 6. The patient s total hospital stay was 11 days. The hospital duration for pediatric patients ranged from 1 to 20 days. The longest hospital stay was the 14- day-old patient, ASA 4E, with a right saccular laryngeal cyst who underwent TORS-assisted excision of the saccular cyst (patient 5). The patient was kept intubated after surgery, extubated on postoperative day 3, and received 5 days of perioperative steroids. Although the patient s procedure and hospital course were uncomplicated, the patient was monitored in the neonatal intensive care unit predominantly until per oral feeding status could be assured. Three of the 16 patients had previous traditional surgical approaches prior to TORS. This includes a 2- year-old patient with a type 2 laryngeal cleft and redundant supraglottic tissue who has required no further surgery after subsequent successful TORS repair (patient 6); a 12-year-old patient with lymphangioma involving the left hypopharynx and tongue base who has undergone one additional TORS procedure (patient 11); and a 12-year-old patient with history of caustic ingestion with resultant pharyngeal, supraglottic, and esophageal strictures who has required multiple endoscopic procedures for dilation (patient 12). 250 To date, two of three patients who had a preexisting tracheostomy tube were successfully decannulated following their TORS procedure, with only the patient with a history of caustic ingestion and multiple levels of aerodigestive scarring remaining tracheostomy dependent. DISCUSSION Since Rahbar et al. first published the roboticassisted repair of laryngeal clefts in pediatric patients, the technology and its applications have been advancing rapidly. 2 When analyzing robotic surgery in general, factors such as capital expense, instrument size, haptic feedback loss, docking time, operative time, simulation and training, complications, operative cost, and patient outcomes are a few considerations which have been evaluated. 10 Following the current debate regarding adult TORS, these same concerns regarding feasibility, teachability, safety, efficacy, and outcomes will need to be addressed for pediatric TORS. 11 Many early reports have appropriately focused on safety, feasibility, operative time, and docking time. 3,5,6,8 Pediatric TORS is a clear example of early development and exploration phases of surgical innovation in both its application in the pediatric airway and description in the literature In attempts to have more evidencebased innovation, adopting the IDEAL model, as described by McCulloch, is helpful and recommended. 12 The IDEAL model is a descriptive model of surgical technique delineating the stages of Innovation, Development, Exploration, Assessment, and Long-term study. The model includes descriptive guidance on the types of expected studies in each stage, as well as the clinical and scientific goals to be accomplished in each stage. Our case series adds to the literature in several ways. In representing one of the largest case series, it nearly doubles the number of cases presented in the literature to date. A wide range of pathologies was successfully and safely addressed, including hypopharyngeal and laryngeal lymphatic malformations, laryngeal clefts, saccular cysts, pharyngeal strictures, tongue base

5 masses, and cysts. The generalizability of this series is novel in that it lies outside of the range of most of the published literature that includes lingual tonsillectomies and tongue-base reductions. It also demonstrates safety and feasibility in a wide range of patient ages and weights, including the carefully selected neonates (a 2.5- kg 26 day old and a 3.7-kg 10 day old). Because of the wide range of procedure types and pathologies addressed, a significant trend of decreased operative or surgical time is not to be expected. Our reported complications are within the expected complications for similar traditional transoral approaches in children with significant airway, respiratory, and comorbid pathologies. It is difficult to draw strict comparison of open or traditional transoral procedures in all cases because many of the cases do not have appropriate counterpart comparative procedures or data. The complications seen in this series, although not directly from robotic instrumentation or surgery, could be the result of prolonged mouth gag suspension times, more extensive tissue manipulation, or tissue effects of noncompliant armored endotracheal tubes. However, the advantages of wristed instrument control, threedimensional visualization, and more precise surgery were affirmed in our qualitative experience in this series. For example, we believe that use of the robot allowed more sutures to be placed in small spaces; more precise control of the laser; and in some cases, multilayer closure with greater exposure than we typically experience in standard endoscopic procedures. We believe there are several critical elements for success in this case series. First, we had a team with two robotic surgery experienced attending surgeons. Secondly, the experienced bedside surgeon facilitated patient safety, surgical access, and robotic surgeon. We also selected older, bigger children with relatively assessable pathology before attempting more challenging cases in younger, smaller children. We excluded patients with malignancy and vascular tumors (other than lymphangioma). We were also prepared to convert to traditional surgical methods if the procedure could not be safely and effectively addressed with the robot. With experience, we learned the importance of carefully selecting the appropriate endotracheal tube for the patient, resting the tongue (e.g., release from prolonged retraction), and consideration for overnight intubation in long surgical cases. We believe that surgeons can also decrease operative time with more experience. These data help solidify our understanding of key challenges and future development of TORS for pediatric airway surgery: 1) securing the airway with the appropriate laser-safe endotracheal or tracheostomy tubes; 2) identifying the appropriate exposure; 3) obtaining surgical access with the robotic arms allowing for unrestricted mobility; 4) the critical role of the bedside surgeon in protecting the airway and the patient in addition to assisting the robotic surgeon. As the technology continues to advance with smaller instruments, arms, and optics, the initial challenges lessen and the potential applications widen. Because all of the surgical instruments adapted for use in pediatric TORS airway surgery were designed for general and urologic surgical applications, it is essential for the future innovation and advancement of pediatric robotic airway surgery to have specialized airway instrumentation. As safety concerns diminish and indications are being developed, critical assessment of the future clinical value pediatric TORS for airway surgery should be assessed. 10 CONCLUSION Transoral robotic surgery can be safe and feasible, even in very small neonates. A wide array of pathologies and sites, including the hypopharynx, larynx, and proximal trachea, can be successfully addressed. Whereas the diversity of procedures presented limits robust comparison to traditional procedures, this study demonstrates advancements in application, feasibility, and safety. Future advancements in technology, smaller instruments, specialized instruments, and airway-specific optics can help broaden robotic applications. BIBLIOGRAPHY 1. Faust R, Kant A, Lorinez A, Younes A, Dawe E, Klein M. Robotic endoscopic surgery in a porcine model of the infant neck. J Robotic Surg 2007;1: Rahbar R, Ferrari L, Borer J, Peters C. Robotic surgery in the pediatric airway: application and safety. Arch Otolaryngol Head Neck Surg 2007; 133: Mehta D, Duvvuri U. Robotic Surgery in Pediatric Otolaryngology: Emerging Trends. Laryngoscope 2012; 122:S105 S Kayhan F, Kaya K, Koc A, Altintas A, Erdur O. Transoral Surgery for an infant thyroglossal duct cyst. Int J Pediatr Otorhinolaryngol 2013;77: Leonardis R, Duvvuri U, Mehta D. Transoral robotic-assisted lingual tonsillectomy in the pediatric population. JAMA Otolaryngol Head Neck Surg 2013;139: Wine T, Duvvuri U, Maurer S, Mehta D. Pediatric transoral robotic surgery for oropharyngeal malignancy: A case report. Int J Pediatr Otorhinolaryngol 2013;77: Kokot N, Mazhar K, O Dell K, Huang N, Lin A, Sinha UK. Transoral robotic resection of oropharyngeal synovial sarcoma in a pediatric patient. Int J Pediatr Otorhinolaryngol 2013;77: Leonardis R, Duvvuri U, Mehta D. Transoral robotic-assisted laryngeal cleft repair in the pediatric patient. Laryngoscope 2014;124: Ferrell J, Roy S, Karni R, Yuksel S. Applications for transoral robotic surgery in the pediatric airway. Laryngoscope 2014;124: Cundy T, Marcus H, Hughes-Hallet A, Najmaldin A, Yang G, Darzi A. International attitudes of early adopters to current and future robotic technologies in pediatric surgery. J Pediatr Surg 2014;29: Weinstein G, O Malley B, Desai S, Quon H. Transoral robotic surgery: does the ends justify the means? Curr Opin Otolaryngol Head Neck Surg 2009;17: McCulloch P, Altman D, Campell B; Balliol Collaboration, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374: Barkun JS, Aronson JK, Feldman LS; Balliol Collaboration, et al. Evaluation and stages of surgical innovations. Lancet 2009;374: Ergina PL, Cook JA, Blazeby JM; Balliol Collaboration, et al. Challenges in evaluating surgical innovation. Lancet 2009;374: Byrd JK, Leonardis RL, Bonawitz SC, Losee JE, Duvvuri U. Transoral robotic surgery for pharyngeal stenosis. Int J Med Robot 2014;10: Thottam PJ, Govil N, Duvvuri U, Mehta D. Transoral robotic surgery for sleep apnea in children: is it effective? Int J Pediatric Otorhinolaryngol 2015;79: