Zenker's diverticulotomy with bipolar tissue sealer: Retrospective review of safety and short-term outcomes.

OBJECTIVES: The objective of this study is to analyze and report the institution's experience using the Enseal bipolar tissue sealing device to perform endoscopic Zenker's diverticulotomy. Safety and early functional outcomes are presented as primary endpoints of the study. MATERIALS & METHODS: This is a retrospective study of consecutive patients with Zenker's diverticulum (ZD) treated via a transoral approach using a rigid endoscope and a bipolar tissue sealer between 2011 and 2019. Demographic data, ZD size, complications and preoperative versus postoperative symptoms were assessed. The Eating Assessment Tool-10 (EAT-10) questionnaire was used to evaluate functional outcomes, and statistical comparisons were made using the student's t-test. RESULTS: Nineteen ZD patients were identified who underwent rigid endoscopic diverticulotomy using a bipolar tissue sealer. The mean age was 71 years and 74% were male. The mean diverticulum size was 3.1 cm. There were no intraoperative or postoperative complications identified. Average pre-operative EAT-10 score was 21 and post-operative EAT-10 score was 12 at one to two weeks after surgery (p = .05). CONCLUSIONS: Evidence from this preliminary study of endoscopic Zenker's diverticulotomy using the Enseal device indicates that it is both safe and effective. Several features of the device, including its narrow profile, articulation and rotation capability, rapid repeatable activation, and low risk of collateral thermal injury, make it an appealing option for endoscopic Zenker's diverticulotomy.

Orbital tumors.

Neoplasms involving the orbit are divided into primary and secondary types. Primary orbital tumors are rare, include a wide variety of histopathologic types, are usually benign, and most often are managed surgically. Secondary orbital tumors are most often malignant, arise from the paranasal sinuses, and are managed with multiple modalities in a planned fashion. This article discusses primary and secondary orbital tumors, including their evaluation and management.

Resorbable fixation in facial plastic and head and neck reconstructive surgery: an initial report on polylactic acid implants.

OBJECTIVES: The purpose of this study was to evaluate and report our initial experience with a resorbable fixation system in facial cosmetic and head and neck reconstructive surgery. The specific goals were to determine in which settings the absorbable system could be used, to evaluate the outcome of its use, to detail complications that occurred, and to report our observations on advantages and disadvantages of the system compared with traditional methods of osteosynthesis and fixation. STUDY DESIGN: A retrospective review of the initial 30 consecutive patients at the University of California, San Diego Division of Head and Neck Surgery who received polylactic acid (PLA) implants. SETTING: Academic tertiary referral/level I trauma center. METHODS: Criteria for inclusion into the study were any patient over age 18 who underwent a procedure involving the use of a PLA implant between March 1999 and October 2000. In addition to the typical indications for metal plate or mesh implantation, PLA was used for "protected bone regeneration." Detailed records were kept of all patients in whom PLA implants were used, including the exact procedure and type of implant. All patients were operated by the authors. Operative reports, hospital charts, and office records were analyzed for any perioperative or postoperative complications. The attending surgeon noted advantages and disadvantages of the system. Patients have been followed from 2 to 18 months at the time of this report and are part of an ongoing long-term follow-up study. RESULTS: PLA implants were used in 35 procedures on 30 consecutive patients (multiple unilateral fracture repairs were counted as a single procedure). Uses included fixation of craniofacial fractures (zygomaticomaxillary, orbit floor, frontal bone [N = 9]; fixation of craniofacial osteotomy [N = 8]; protected bone regeneration [N = 3]; mandible, cranial bone donor site [N = 2]; bone grafting [N = 2]; craniectomy reconstruction [N = 2], and soft tissue suspension [endoscopic browlifting, N = 6, static facial suspension, N = 1]). There were 4 complications in this series: 2 partial flap losses, 1 in a patient who had had preoperative radiation and the other in a heavy smoker; 1 infected cranial bone flap in a patient who had had two prior surgeries and radiation; and 1 wound dehiscence over a plate that was improperly contoured. Advantages noted by the surgeons were ease of contouring the mesh or plates, including in situ reshaping, apparent decrease in operative time, low implant profile, minimal soft tissue reaction, and radiolucency of the system, allowing postoperative imaging without metallic artifact. CONCLUSIONS: We found the PLA system to be highly effective, and noted no absolute contraindications to its use compared with standard metal plating systems. The 11% incidence of complications in this series was acceptable and probably not the result of the PLA implant material, although further experience is needed to determine the role of PLA implants in radiated tissue. The primary advantages to PLA appear to be its ease of use, radiolucency, eventual resorption, and, possibly, improved precision of reduction. The use in protected bone regeneration may also be an advantage, but long-term follow-up of our population will be needed to determine this. Based on short-term outcome analysis of our initial experience with PLA implantation, it appears to be an efficacious and safe technology for applications in head and neck and facial plastic surgery.

Management of the neck in patients with head and neck cancer treated by concurrent chemotherapy and radiation.

The current high level of interest in organ preservation strategies for patients with advanced squamous cell carcinoma of the head and neck undoubtedly will result in increasing numbers of patients managed initially with chemotherapy and radiation, either sequentially or concurrently. In some protocols, surgery, and neck dissection in particular, will either be mandatory or offered based on the degree of response to treatment and initial stage of neck disease. Head and neck oncologic surgeons need to be involved and at the forefront of such trials, to allow meaningful data regarding pathologic response to treatment to be obtained, as well as to define the role of surgery in such patients. Although present data is limited, it would appear that in patients achieving a complete response to chemoradiation, the role of neck dissection may be more limited than in the past, even for patients with N2 to N3 neck disease at presentation. Surgical complications may be increased in this heavily treated patient population, and subsequent surgery should be designed to minimize the risk of wound complications, especially if performed before the patient has made a full recovery from the metabolic and immunologic derangements associated with chemoradiation. Head and neck surgeons need to play an active role in the design and conduct of chemoradiation trials so that these and other relevant questions will be answered by the data generated.

Observations on control of N2 and N3 neck disease in squamous cell carcinoma of the head and neck by intra-arterial chemoradiation.

Patients with head and neck squamous cell cancer with N2 and N3 neck disease have a poor prognosis and are at risk to fail regionally despite combined surgery and radiation. Twenty-two patients with N2 and N3 neck disease (and T3-4 primaries) were treated with intra-arterial, high-dose cisplatin (CDDP), 150 mg/m2 per week for 4 weeks, and concurrent radiation. All patients were followed for at least 2 years or until death from any cause. Twenty patients had a complete response at the primary site. Two of the 20 with a complete response later had a neck recurrence and died. Five patients with palpable nodes after treatment underwent fine-needle aspiration (FNA), one of which was positive and two suggestive of cancer. Six neck dissections were performed in this group, only two of which had positive nodes. This chemoradiation protocol may offer reasonable control of N2 and N3 neck disease in advanced head and neck squamous cell cancer. Neck dissection appeared to be necessary in only those patients with nodes 8 weeks after treatment in whom FNA was positive or suggestive of cancer. Because of the relatively small size of this series, additional accrual and monitoring of such patients is planned.

Phase I trial of retinoic acid and cis-platinum for advanced squamous cell cancer of the head and neck based on experimental evidence of drug synergism.

OBJECTIVE: Cis-platinum and 13-cis-retinoic acid have received much attention in the treatment of head and neck squamous cell cancer. Even though they have different mechanisms of action, little information is available on their interaction. This paper reviews experimental evidence for retinoic acid-cis-platinum synergy and presents toxicity data from patients with stage IV head and neck squamous cell cancer participating in a phase I trial combining 13-cis-retinoic acid and cis-platinum. METHODS: Patients were given 13-cis-retinoic acid orally daily for 7 days before and daily during high-dose (150 mg/m2 per week for 4 weeks) intraarterial cis-platinum treatment with concurrent radiation. Toxicity was scored with use of the cancer and leukemia group B scale. RESULTS: In the phase I clinical trial, 15 patients were treated to determine a maximum tolerated dosage for 13-cis-retinoic acid of 20 mg/day. Grade 4 hematologic toxicity was dose limiting in 3 of 8 patients treated with 40 mg/day and in 1 patient treated with 60 mg/day. There were no deaths caused by toxicity; 12 of the 15 patients received all four weekly doses and the remaining 3 received three doses. Of 10 patients with fully evaluable data, all achieved a complete response at the primary site and 9 had a complete response in the neck. One patient had persistent neck disease after chemoradiation, and this tumor was removed with neck dissection. CONCLUSIONS: 13-Cis-retinoic acid and cis-platinum are strongly synergistic against head and neck squamous cell cancer in vitro. Pretreatment with retinoic acid results in stronger synergy than concurrent drug exposure alone. Preliminary clinical experience with combined retinoic acid and cis-platinum in a design that parallels the in vitro study indicates that toxicity is acceptable with 13-cis-retinoic acid dosages of 20 mg/day in a high-dose-intensity intraarterial chemoradiation regimen.

Orbital decompression in Graves' disease.

OBJECTIVE: The authors' experience with surgical decompression of the orbits in patients with Graves' orbitopathy is reviewed. DESIGN: One hundred twenty-six consecutive primary orbital decompressions were retrospectively studied. SETTING: Tertiary care university hospitals. PATIENTS: All patients were referred by ophthalmologists for surgical decompression after failure of a trial of oral steroid therapy, and many had had orbital irradiation. INTERVENTION: Antral-ethmoidal or transconjunctival surgical decompression was accomplished in all. MAIN OUTCOMES: Measurements of visual acuity, ocular motility, and proptosis were accomplished preoperatively and a minimum of 3 months postoperatively. Surgical complications were tallied. RESULTS: Mean reduction of proptosis by antral-ethmoidal decompression was 5.3 mm, and 3.6 mm by the transconjunctival approach. Visual acuity improved in 34 orbits, was unchanged in 91 orbits, and decreased in one orbit. In a subgroup of 30 patients in whom ocular motility was quantified by prism cover test preoperatively, motility was unchanged or improved in 21 and was decreased in nine. Complications were infrequent. CONCLUSION: The antral-ethmoidal and transconjunctival approaches to orbital decompression are safe and effective.

Metabolism in vitro of radioiodinated N-isopropyl-p-iodoamphetamine by isolated hepatocytes.

An in vitro technique for the determination of radiopharmaceutical metabolism has been developed using isolated hepatocytes. Radioiodinated N-isopropyl-p-iodoamphetamine (IMP; iofetamine, USP) was employed a model tracer in these studies because its labeled metabolites are well-characterized. Hepatocytes isolated from the rat and human produced labeled metabolites in vitro for up to 4 h in a manner similar to that reported for humans in vivo. Identical metabolites were generated by all cell types investigated, but the rate of metabolism differed (rat >> human; female > male; fresh > frozen). The utility of this methodology for the preclinical evaluation of potential radiopharmaceuticals is described.

'Medial maxillectomy' for lateral nasal wall neoplasms.

Lateral rhinotomy and "medial maxillectomy," an en bloc resection of the medial maxillary sinus, ethmoid sinus with the lamina papyracea, medial orbital floor, and lacrimal fossa-duct, have been advocated for lateral nasal wall neoplasma. Experience with 35 (of 41) patients followed up at least 30 months (median, 57 months) postoperatively is reported. There was a 9% recurrence for benign tumors and 15% for malignant neoplasms, the latter only in the patients with nonmelanoma malignant neoplasms not receiving postoperative radiotherapy. The most frequent complications were cavity crusting, epicanthal scarring, and epiphora.

Management of patients with facial trauma and associated ocular/orbital injuries.

Ocular injury can be associated with facial fractures in a significant percentage of cases. It is mandatory for surgeons treating such fractures to be familiar with the types of orbital injuries, the appropriate physical examination and diagnostic tests, and the management techniques involved in treating traumatic visual loss. This article reviews the diagnostic and therapeutic approaches to this important problem.

The use of stabilization plates in the immediate repair of defects following mandibular resection.

The results of immediate stabilization for surgical defects of the mandible in 18 patients are presented. Fourteen patients with malignant lesions underwent immediate stabilization without bone grafting, but with associated myocutaneous flap soft tissue reconstruction. Four patients with benign lesions were treated with immediate stabilization and bone graft reconstruction, but without myocutaneous flap soft tissue reconstruction. Results at from 4 to 34 months reveal two bone plates lost to massive intraoral exposure. The remaining plates remain in place with excellent functional and cosmetic results.

Septal chondromucosal flap with preservation of septal integrity.

Nasal septal flaps are a convenient source of lining and support in nasal reconstructive surgery. Most technical descriptions of these flaps demonstrate designs that result in septal perforation. By properly planning the design of a contralateral mucosal flap, septal perforation can be avoided when septal chondromucosal flaps are used. Eight such flaps have been used by the author, four to provide lining and support in total nasal reconstruction after removal of very large basal cell cancers, and four to repair cerebrospinal fluid leaks. None of these eight patients developed septal perforations. Details of the operative technique and illustrative cases are presented.

The efficacy and safety of transantral ethmoidectomy.

With the advent of new endoscopic instruments, rhinologists are reassessing and modifying ethmoidectomy techniques. Despite this renewed interest, the transantral ethmoidectomy has received little attention, even though this procedure has the advantages of avoiding an external incision, safely delineating the medial orbital wall, and simultaneously treating ethmoid and maxillary sinus disease. The present study compared 74 transantral ethmoidectomy procedures and 47 external ethmoidectomy procedures. The two groups of patients were comparable with respect to age and gender. There was no statistical difference between the two groups with regard to blood loss. Complications were less frequent in the transantral group. Of the 97 patients treated for ethmoid sinusitis, outcome was more successful in the transantral group than in the external ethmoidectomy group when assessed by the need for additional medical or surgical treatment.

An autologous fibrinogen-based adhesive for use in otologic surgery.

Successful middle ear surgery requires the availability of a safe, effective bonding material. Side effects caused by synthetic materials have led to the use of biologic adhesives; however, they carry the risk of transmission of infectious disease if they are prepared from pooled human blood. A procedure for the production of an autologous fibrinogen-based adhesive using polyethylene glycol to precipitate the fibrinogen-factor XIII component from plasma is described. This procedure requires 40 ml of whole blood and approximately 3 hours' preparation time, and it can be performed in any blood bank with the facilities for sterile techniques. This adhesive has been used successfully for otologic surgery in 12 patients, and further study of the use of this biologic adhesive for other microsurgical techniques should be undertaken.

Pseudotumor of the head and neck masquerading as neoplasia.

Four unusual cases of pseudotumor, which had clinical and radiographic findings suggesting neoplasia, are presented. One involved the maxillary sinus, destroying the lateral wall, and extending to the infratemporal fossa and the orbit. The second presented as an enlarging lacrimal gland tumor with ipsilateral parotid adenopathy, and the third as a large parapharyngeal mass that was diagnosed as a lymphoma on aspiration cytology. The fourth case documented the rare occurrence of a congenital pseudotumor, manifesting as proptosis in a neonate and thought to be a fibrosarcoma on frozen section study. Aggressive pseudotumors must be distinguished from malignancy to avoid unnecessary surgery or irradiation. Some cases can be distinguished from neoplasms by their dramatic response to oral steroid therapy, and others by characteristic features on CT or MRI. Due to the diverse cellular proliferation, aspiration cytology is infrequently helpful and diagnosis can be difficult on frozen section study. An approach to the diagnosis and management of pseudotumors is detailed.

Surgical anatomy of the orbit.

A firm knowledge of orbital anatomy is mandatory for any surgical specialist dealing with this important region. An understanding of orbital anatomy can be acquired systematically by studying each of its component systems (skeletal, fascial, vascular, neural and muscular, and lacrimal). Frequent review of this topic, and the study of anatomic detail in cadaver and surgical dissections, should result in safer, more secure surgery in this complex area.

Management of endocrine orbitopathy.

Endocrine ophthalmopathy remains the most common cause of proptosis in adults. In a small but significant percentage of patients, vision can be threatened, requiring prompt intervention. In the patients who fail to respond to medical management with high-dose steroids, surgical decompression is indicated. The Walsh-Ogura antral-ethmoidal decompression is the most widely used approach at this time. Radiation therapy is a therapeutic modality that is probably best reserved for patients who fail to respond to steroids or surgery, or in whom these two approaches are not possible. The management of endocrine orbitopathy continues to be directed toward relief of symptoms. A multidisciplinary approach, involving the endocrinologist, ophthalmologist, otolaryngologist-head and neck surgeon, and oculoplastic surgeon is often required to achieve the best outcome.

Biochemical characterization of autologous fibrinogen adhesive.

Fibrinogen-based adhesive, derived from pooled human plasma, has been used in Europe with great success in otologic surgery, but has not been approved for use in the U.S. because of the risk of transmitting hepatitis. Autologous fibrinogen, derived by polyethylene glycol precipitation from the blood of an individual patient would avoid this risk, and has been shown to be relatively safe to the ear in animal studies. A study of the biochemical composition of this autologous fibrinogen concentrate derived from 15 human volunteer donors was performed. The mean starting plasma fibrinogen was 2.12 mg/ml (range 1.59-3.22 mg/ml). When 10% polyethylene glycol was used to precipitate the fibrinogen, the concentrate contained, on the average, 31.8 mg of fibrinogen/ml. The percent yield averaged 54.9%, and the protein in the final product was 91.9% fibrinogen. Increasing the polyethylene glycol concentration in the precipitation process to as high as 15% resulted in an increased yield as high as 91%, but the protein in the final product was only 42.5% fibrinogen. Polyacrylamide gel electrophoresis confirmed that the predominant protein in the 10% polyethylene glycol precipitate was fibrinogen. These data suggest that highly concentrated fibrinogen can be derived with relative ease from single donor human plasma, and that the product is relatively pure. When combined with thrombin and calcium chloride, this concentrate should provide an adhesive that avoids the risks associated with fibrinogen adhesive derived from pooled blood.