John M. Fredrickson

Free Flap Reconstruction of the Head and Neck: Analysis of 241 Cases

OBJECTIVE: We undertook this study of free flap reconstruction of the head and neck to stratify patients and procedures, to determine how donor site preference changed over time, to assess medical and surgical outcomes, and to identify variables associated with complications. METHODS: We analyzed computerized medical records from 236 patients who underwent a total of 241 reconstructions at a tertiary academic medical center in St. Louis between 1989 and 1998. We created a more detailed retrospective database of 141 of those patients by using 48 perioperative variables and 7 adverse outcome measures. Multivariate statistical models were used to analyze associations between variables and outcomes. RESULTS: The fibula became the preferred donor site for mandibular reconstruction, and the radial forearm became the preferred donor site for pharyngoesophageal reconstruction. For the 241 procedures, the mortality rate was 2.1%, the median length of stay was 11 days, and the flap survival rate was 95%. Administration of more than 7 L of crystalloid during surgery and age over 55 were associated with major medical complications. Blood transfusion, prognostic comorbidity, and number of surgeons correlated with length of stay. Cigarette smoking and receipt of more than 7 L of crystalloid during surgery were associated with overall flap complications, and weight loss of more than 10% before surgery, more than one operating surgeon, and cigarette smoking were associated with major flap complications. CONCLUSIONS: Risk to patients and transferred tissue is low in free flap head and neck reconstruction. Age, smoking history, and weight loss should be considered during patient selection. Fluid balance should be considered during and after surgery. Division of labor for patient care should be carefully delineated among surgeons in a teaching setting.

Otologics middle ear transducer™ ossicular stimulator: Performance results with varying degrees of sensorineural hearing loss

Objectives This study was conducted to demonstrate the safety and efficacy of the Otologics Middle Ear Transducer™ (MET™) Ossicular Stimulator and, in particular, to compare the audiologic benefits of this novel form of electromechanical stimulation with those of conventional acoustical amplification. Material and Methods A total of 282 patients were implanted with the device in Europe and the USA. Pure-tone audiometry, speech recognition and subjective assessment of benefit were tested before the surgery and 2, 3, 6 and 12 months afterwards. The US patients were fitted with a digital hearing aid for a minimum of 4 weeks prior to surgery, and the same benefit measures were performed with the digital hearing aid and their “walk-in” hearing aid. Results Group mean postoperative bone and air conduction thresholds did not change significantly from preoperative levels. Postoperative air conduction thresholds decreased slightly in some individual patients, due to the mass loading effect exerted by the transducer on the ossicles. Sufficient gain was available to reach target prescription levels for moderate to severely impaired hearing individuals. Speech and subjective assessment of patient preference indicated that patients did as well or better with the MET Ossicular Stimulator than with their “walk-in” aid or the standardized digital aid. Conclusion The capability of the MET Ossicular Stimulator to provide appropriate gain as a function of degree of hearing loss indicates that the device is a viable treatment for moderate to severe sensorineural hearing loss in adults.

Cervical metastases from unknown primaries: Radiotherapeutic management and appearance of subsequent primaries

Between 1964 and 1986, 72 patients who presented with squamous or undifferentiated metastatic carcinoma to neck nodes, where the primary tumor could not be found by standard clinical procedures, were treated at the Mallinckrodt Institute of Radiology. These cases were managed in the following manner: biopsy and radiotherapy in 46 out of 72 patients, radiotherapy (RT) and a planned neck dissection in 14 out of 72, and neck dissection after failure to achieve a complete response (CR) with RT in 12 out of 72. Minimum follow-up was 2 years. The initial CR rates for stages N1, N2a, N2b, N3a, and N3b were 83%, 93%, 61%, 50%, and 33%, respectively. The long-term neck tumor control for the same stages was 83%, 71%, 67%, 44%, and 50%, respectively. One patient had soft tissue necrosis and two had carotid artery ruptures, one of which left no symptomatic sequelae. Twenty-one out of 72 patients developed subsequent primary tumor. Only one of these patients survived. This incidence was not affected significantly by prophylactic treatment of the mucosal areas except in patients with bilateral neck nodes, undifferentiated or poorly differentiated histologies, and/or posterior cervical node involvement. A multivariate analysis showed that prognosticators of an improved disease-free survival were: a complete clearance of tumor by the end of radiotherapy (p less than 0.0009) and no appearance of a subsequent primary tumor (p = 0.035). The only factor that correlated with an increased loco-regional control was having a complete response by the end of radiotherapy (p less than 0.00009). The recommended management and possible ways of preventing the appearance of subsequent primaries will be discussed.

Clinical-severity staging system for oral cavity cancer: Five-year survival rates ☆ ☆☆ ★ ★★

The objective of this research is to improve the classification and survival estimates for patients with oral cavity cancer by combining cancer symptom severity and comorbidity with the current TNM staging system. The study design is a retrospective medical record review that uses explicit coding criteria. The medical records of 277 patients receiving initial treatment at the Washington University Medical Center between 1980 and 1989 were reviewed. Multivariate analysis identified patient factors that significantly affected 5-year survival. These patient factors, symptom severity and comorbidity, were combined with TNM to create a composite clinical-severity staging system. The overall 5-year survival rate was 46% (128/277). Survival rates by TNM stage were as follows: stage I, 72% (36/50); II, 54% (45/84); III, 37% (24/65); and IV, 29% (23/78) (χ 2 = 25.27, P = 0.001). When patients were grouped according to the clinical-severity staging system, survival rates were as follows: stage I, 77% (33/43); II, 56% (45/80); III, 42% (43/103); and IV, 14% (7/51) (χ 2 = 40.62, P = 0.001). Survival estimates can be improved by adding carefully studied and suitably defined patient variables to the TNM system. The current TNM staging system for oral cavity cancer is based solely on the morphologic description of the tumor and disregards the clinical condition of the patient. Patient factors, such as cancer symptom severity and comorbidity, have a significant impact on survival. Continued exclusion of patient factors leads to imprecision in prognostic estimates and hinders interpretation of clinical studies.

Squamous cell carcinoma of the pyriform sinus: A nonrandomized comparison of therapeutic modalities and long‐term results

From January 1964 through December 1991, 408 patients with squamous cell carcinomas involving the pyriform sinus were treated at Washington University Medical Center. Their ages ranged from 29 to 83 years (mean, 62.3; median 59) and the male to female ratio was 5:1. The mean duration of symptoms prior to diagnosis was 3.9 months (range 1 to 32 months) and 89% had a smoking or ethanol history. Sixty‐seven percent had T3 or T4 lesions and 87% were stage III or IV at presentation. Sixty‐nine percent had neck metastases. The treatment strategy varied with respect to radiation and reconstruction. Prior to 1978, preoperative radiation (3.5 to 5000 cGy) was used. Postoperative radiation was given thereafter (600+ Gy). Since 1982, flap reconstruction (usually pectoralis major myocutaneous) has been used to close the partial laryngopharyngectomy (PLP) defect. Almost all N0 necks were treated by radiation or surgery and all N1‐N3 lesions were treated by combined therapy. Pyriform tumors were subdivided into three groups: 1. one‐wall lesions (n = 48), 2. medial‐wall lesions which involved the aryepiglottic fold or supraglottis (N = 267), and 3. two‐ or three‐wall lesions which extended to the pyriform apex or post‐cricoid region (N = 93). Ninety‐five patients had single‐modality therapy and 302 had combined treatment. Two hundred seven patients had conservation surgery (PLP) and 157 had total laryngopharyngectomy alone or in combination with radiation. Thirty‐three patients were treated by radiation alone. Eleven patients were excluded from the study because of distant metastases (TxNxM1) at presentation. The cumulative survival (NED) at 5, 10, 15, and 20 years was 56%, 35%, 31%, and 20%, respectively. The cumulative locoregional control rate was 71%. At 5 years (NED), the cure rates for one‐wall lesions (73%) were better than for medial‐wall lesions (63%) or 2‐ and 3‐wall lesions (49%).

Totally Implantable Hearing Aids: The Effects of Skin Thickness on Microphone Function

With the advent of totally implantable hearing aids, the question of the impact of the choice of implantation site on microphone function has yet to be fully addressed. We investigated the effects of skin thickness on microphone function over a 2-week period in a porcine model. Sound attenuation was found to be directly proportional to skin thickness within the range of 0.5 to 3.0 mm. A decrease in resonant frequency of 500 Hz was noted after implantation under a skin thickness of 3.0 mm. The general shape of the frequency response curves was maintained across all thicknesses tested. Attenuation (dB loss) across the range of 500 to 8,000 Hz appeared to be linear over the various skin thicknesses measured, with a regression coefficient (r = .99 at 1 kHz and r = .99 at 3 kHz). To minimize attenuation and exploit the sound-collecting qualities of the external ear, the deep meatal skin appears to be a favorable position for implantation.

Fibular and iliac crest osteomuscular free flap reconstruction of the oral cavity

A method for reconstruction of oral cavity soft tissues using segmentally or axially supplied free muscle flaps harvested as a unit with their bone components is presented. Both fibular/soleus and iliac crest/internal oblique free flaps are documented, and the pros and cons of each donor site are presented.

Assessment of Two Objective Voice Function Indices

In the care of patients with voice disorders, physicians, speech pathologists, and other health care professionals routinely make diagnoses, recommend treatment, and evaluate outcomes. Although objective and subjective measures exist, unfortunately, there is no widely accepted, valid method for classifying voice disorders and assessing outcome after voice treatment. In the present research, the relationship between two previously created multivariate objective voice function indices, the weighted odds ratio index and the multivariate logistic regression index, and subjective assessment of voice function was evaluated. Twenty-three adult patients presenting to a speech science laboratory for evaluation of voice disorders were studied in this prospective observational study together with 12 normal volunteers as controls. Vocal function was measured on 14 different parameters with a protocol that included a multichannel input for simultaneous assessment of acoustic and physiological parameters. Each patient was recorded reading the standard passage “The North Wind and the Sun,” and recordings were then evaluated by the GRBAS scale. Overall, there was a statistically significant relationship between the weighted odds ratio index and multivariate logistic regression index and mean GRBAS scores. This research demonstrates that the voice function values calculated from two different multivariate objective voice function indices are significantly associated with subjective voice assessments. These multivariate objective voice indices may be appropriate for use in clinical trials and outcomes research on treatment effectiveness for voice disorders.

SYMPTOMS AS AN INDEX OF BIOLOGIC BEHAVIOR IN HEAD AND NECK CANCER

The TNM staging system for head and neck cancer is based on the morphologic description of the tumor and disregards the clinical condition of the patient. Cancer symptoms were evaluated as a biologic index of disease to improve survival estimates. The medical records of 1010 patients receiving initial cancer treatment between 1980 and 1991 were retrospectively reviewed. The mean survival duration was 62 months for the entire population. By use of SAS statistical software (SAS Institute, Cary, NC), 48 symptom variables were screened by univariate analysis, and 23 of these variables were selected for entry into a Cox proportional hazards model on the basis of survival duration. Dysphagia, otalgia, neck lump, and weight loss were identified as independent predictors of survival duration (P <0.01). A composite symptom-severity staging system was created on the basis of the 4 symptoms. Mean survival duration (95% CI) by symptom-severity stage was as follows: none, 74 months (70 to 79 months); mild, 56 months (51 to 61 months); moderate, 40 months (33 to 47 months); and severe, 31 months (22 to 41 months) (χ2 = 30.8, P = 0.0001). Survival duration by TNM stage was as follows: I, 89 months (82 to 95 months); II, 71 months (65 to 78 months); III, 53 months (47 to 59 months); and IV, 42 months (37 to 47 months) (χ2 = 56.2, P = 0.0001). When symptom-severity stage was entered in a proportional-hazards model along with TNM stage, comorbidity, age, and alcohol use, all 5 variables were independently predictive of survival duration (risk ratio: symptom severity 1.28, TNM 1.33, comorbidity 1.80, age 1.47, alcohol use 1.09). Appropriately defined symptom variables contain important prognostic information, which is independent of the TNM system. Therefore symptoms provide an index of biologic behavior in head and neck cancer.

Multivariate analysis of objective vocal function.

No standard and valid multidimensional index of objective voice function has been developed that integrates the information generated from the multiple objective parameters of voice function. The goals of this research were 1) to identify important objective voice parameters and 2) to create a multidimensional voice function index by combining relevant parameters. We evaluated 97 dysphonic patients and 35 normal volunteers on 14 objective voice parameters. Three multidimensional voice indices were created and evaluated: 1) nonweighted univariate index, 2) weighted odds ratio index, and 3) weighted multivariate regression index. The univariate index required all 14 parameters, while the odds ratio and logistic regression models required only 4 parameters (frequency range, airflow at lips, maximum phonation time, and subglottic pressure). The χ2 values for the 3 models were 37.8, 37.6, and 46.0, respectively. All 3 indices were able to satisfactorily classify voice function as normal or abnormal. However, the regression index performed best.