Malpractice litigation involving iatrogenic surgical vocal fold paralysis: a closed-claims review with recommendations for prevention and management.

OBJECTIVES: We describe the nature of malpractice claims filed involving surgical iatrogenic vocal fold paralysis, review surgical literature for recommendations for prevention of this complication, and suggest management of this complication. METHODS: Data collection was made regarding any closed claims that involved vocal fold paralysis. The results were then analyzed and categorized. The PubMed literature regarding this complication was reviewed, and recommendations on prevention were compiled. Finally, suggestions regarding management based on the current literature and the senior author's 17-year experience in his laryngeal practice are offered. RESULTS: From 1986 to 2007, 112 closed claims involving vocal fold paralysis were reported by the 16 largest malpractice insurers. More than US $10 million ($18 million adjusted for inflation [AJI]) has been paid thus far. The average indemnity was $285,000 ($513,000 AJI). The surgical physician defendants were from multiple specialties, including general surgery (31%), cardiothoracic surgery (12%), neurosurgery (12%), otolaryngology (10%), and orthopedic surgery (5%). The most common procedures were thyroid and parathyroid surgery (32%), cervical disc procedures (16%), thoracic procedures (12%), endarterectomy (9%), and open neck biopsy (6%). The most common claims cited were improper performance (61%), failure to recognize a complication (36%), and consent issues (19%). CONCLUSIONS: Vocal fold paralysis is a complication of many different surgical procedures across multiple specialty lines. Closed-claims analysis can offer a unique glimpse on what went wrong and why patients sue. Modification of techniques and incorporation of new technology may significantly reduce this complication. Preoperative written information on potential complications, and early referral to and management by laryngeal specialists, we believe, may significantly reduce malpractice litigation.

Transcutaneous neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality?

OBJECTIVES: VitalStim therapy was approved by the US Food and Drug Administration in 2001 for the treatment of dysphagia through the application of neuromuscular electrical stimulation to cervical swallowing muscles. This approval was based upon submission of data on more than 800 patients who received this therapy collected by the principal developer and patent-holder of the device. The therapy is marketed as successful in restoring long-term swallowing function in 97.5% of dysphagic patients past the point of requiring a feeding tube and as significantly better than existing therapies. More than 2,500 speech-language pathologists have taken the certification course, and thousands of devices have been sold. To date, however, aside from the developer's own studies, there are no peer-reviewed publications supporting these claims. We sought to evaluate the effectiveness of VitalStim therapy in a heterogeneous group of dysphagic patients. METHODS: We performed a retrospective analysis of 18 patients who received this therapy at an urban tertiary referral center. All patients underwent pretherapy evaluation by speech-language pathologists, including modified barium swallow and/or functional endoscopic evaluation of swallowing and clinical evaluation of swallowing that included assessment of laryngeal elevation, diet tolerance, and swallowing delay, and were then assigned an overall dysphagia severity score. After therapy, all patients underwent the same assessments. Twelve of the 18 also underwent a functional swallowing telephone survey months (range, 1 to 21 months) after their therapy to assess whether the improvement was worthwhile and sustained. RESULTS: Eleven of the 18 patients (61%) demonstrated some improvement in their swallowing. Six of the 18 patients (33%) were improved enough to no longer require a feeding tube. However, of the 5 patients categorized as having "severe dysphagia" before therapy, only 2 showed any improvement, and these patients still required a feeding tube for adequate nutrition. Telephone surveys did confirm that those who improved with their therapy seemed to maintain their progress and that most patients were satisfied with their therapy. CONCLUSIONS: VitalStim therapy seems to help those with mild to moderate dysphagia. However, the patients with the most severe dysphagia in our study did not gain independence from their feeding tubes. The authors conclude that VitalStim therapy clearly has a place in the management of dysphagia, but that the most severely afflicted are unlikely to gain dramatic improvement.

Predictors of laryngeal complications in patients implanted with the Cyberonics vagal nerve stimulator.

OBJECTIVES: Since its approval by the US Food and Drug Administration in 1997 for management of medically refractory seizures, more than 35,000 patients have been implanted with the Cyberonics vagal nerve stimulator. Preliminary reports described transient vocal changes in the majority of subjects, which were thought to be short-term. However, these reports were for the most part based upon perceptual evaluations by the subjects themselves. Later reports described possibly more permanent recurrent laryngeal nerve injury and recommended measuring the nerve diameter to use the safest spiral cuff electrode. To date, no study has systematically evaluated vocal fold mobility in subjects before and after implantation. The objectives of this study were to determine the true incidence of both short- and long-term recurrent laryngeal nerve injuries and determine whether there are any potential indicators to predict in which patients long-term nerve deficits may develop. METHODS: Thirteen subjects underwent preimplantation laryngeal electromyography, videolaryngoscopy, measurement of the maximum phonation time, Voice Handicap Index determination, and Consensus Auditory-Perceptual Evaluation of Voice. Two weeks after implantation, all subjects underwent videolaryngoscopy. Three months after implantation and activation of the device, all subjects were reevaluated. RESULTS: Six of the 13 subjects had significant vocal fold mobility abnormalities at 2 weeks. Significant electromyographic abnormalities were detected before implantation in 5 subjects. All 5 of these subjects, at 3 months after implantation, had prolonged left vocal fold paresis. CONCLUSIONS: The authors conclude that perioperative vocal fold paresis occurs in approximately 50% of subjects. Further, laryngeal electromyography performed before implantation of the vagal nerve stimulator is a statistically significant predictor (p < .05) of which patients may be at risk for extended vocal fold abnormalities. Possible explanations for this phenomenon are offered. Surgical modifications to limit vagal nerve injury are offered.

Posterior cricoarytenoid myoplasty with medialization thyroplasty in the management of refractory abductor spasmodic dysphonia.

Of the approximately 100,000 Americans with primary (idiopathic) laryngeal dystonia, 10% to 15% are thought to havethe abductor form. Botulinum A toxin injected into the posterior cricoarytenoid muscle and/or cricothyroid muscle has been employed as the "gold standard" for therapeutic management; however, successful results are significantly less frequent than with injections for the adductor form. This report describes a new phonosurgical procedure, posterior cricoarytenoid myoplasty with medialization thyroplasty, designed for these refractory patients. Posterior cricoarytenoid myoplasty with medialization thyroplasty has been performed on 3 patients with abductor laryngeal dystonia. All patients had failed at least 5 previous botulinum A injections to the posterior cricoarytenoid and cricothyroid muscles. All patients underwent preoperative and 3 postoperative (2 weeks, 3 months, and 1 year) phonatory analyses. Analysis consisted of recording an aloud reading of a standard passage while a blinded trained speech pathologist counted prolonged voiceless consonants. The patients also completed a satisfaction survey at 1 year. The results demonstrated significant, long-lasting, uniform reduction in breathy breaks in all subjects. The participants all judged their symptoms as greatly improved. Bilateral procedures may be necessary, but should be staged to prevent possible airway compromise. When applied appropriately, posterior cricoarytenoid myoplasty with medialization thyroplasty is a viable tool in the management of refractory abductor laryngeal dystonia.

Benign intracranial hypertension: a diagnostic dilemma.

Benign intracranial hypertension (BIH) (also known as pseudotumor cerebri and empty sella syndrome) remains a diagnostic challenge to most physicians. The modified Dandy criteria consist of, the classic findings of headache, pulsatile tinnitus, papilledema, and elevated cerebrospinal fluid (CSF) pressure, however, these are rarely collectively present in any one patient. Furthermore, these findings can wax and wane over time. Due to the nature of this disease, both signs and symptoms may be intermittent, making definitive diagnosis difficult. Newer imaging studies, particularly the magnetic resonance venogram (MRV) along with a constellation of correlative findings and associated diseases have given new impetus in the diagnosis, treatment, and pathophysiology of this disease. This has led the authors to offer modifications to the classic Dandy criteria. This report presents three representative cases of BIH highlighting many of the newer advances in both diagnosis and treatment of this perplexing disorder.

Otolaryngologic community-acquired MRSA infections in a suburban private practice.

A retrospective review was conducted of all cases of head and neck community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) infections seen in the senior author's suburban private practice during a 12-month period. An office and hospital chart review was performed for all patients identified with culture-positive CA-MRSA infections. Several parameters were evaluated, including site of infection, prior therapy, imaging, comorbid disease, culture and sensitivities, surgical and medical management, and long-term results. Of the 10 patients identified, 3 had infections of nasal soft tissues, 3 had infections of the lips, 2 had infections of the paranasal sinus, 1 had an infection of the chin, and 1 had a diffuse, hemifacial infection. All patients were managed successfully with a combination of surgical drainage, wound care, and antibiotics. CA-MRSA is a burgeoning problem in otolaryngology. Appropriate management-including early recognition, appropriate empirical therapy, prompt and thorough surgical drainage with culture and sensitivities, correct antibiotic choice, and meticulous postoperative care-appears to offer excellent results.

Tonsillectomy using the Colorado microdissection needle: a prospective series and comparative technique review.

Tonsillectomy remains one of the most common surgical procedures performed worldwide. Recent advancements in equipment technology have ushered in several new tonsillectomy techniques. Among these is the Colorado tip electromicrodissection needle. In this report, we describe the technical aspects of this modality and report our results in a prospective study of 12 adults and 13 children. We then compare our results with several published series using a variety of techniques. We found tonsillectomy using the electromicrodissection needle compares most favorably in all criteria examined, including operative and perioperative blood loss, perioperative pain, return to regular diet, and cost. We conclude that electromicrodissection tonsillectomy is an excellent option for all surgeons performing tonsillectomy.