Drugs With a REMS: Benefit/Risk Counseling to Patients

Do you know what to do when counseling a patient on a drug with a REMS designation? Learn more with new guidance from the FDA.
FDA Expert Commentaries and Interviews

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Diagnosis and endoscopic endonasal management of nontraumatic pseudoaneurysms of the cranial base

Background

Nontraumatic pseudoaneurysms of the cranial base are rare and present unique diagnostic and treatment dilemmas compared with both true aneurysms and pseudoaneurysms outside of the cranial base. There is a dearth of knowledge regarding the management of these complicated lesions.

Methods

Nontraumatic pseudoaneurysms of the cranial base internal carotid artery (ICA) were retrospectively identified at the University of Pittsburgh Medical Center through a key word search of cranial base cases from 2010 to 2017.

Results

Three cases were identified, demonstrating pseudoaneurysms of the cavernous and petrous ICA. Each patient underwent diagnostic work-up with computed tomography, magnetic resonance imaging, and angiography, followed by endovascular occlusion and endoscopic endonasal surgery, which resulted in relief of presenting complaints and ablation of the pseudoaneurysm.

Conclusion

Symptomatic cranial base pseudoaneurysms should undergo treatment to obliterate the aneurysm and relieve the mass effect. First, formal angiography is necessary for accurate diagnosis and treatment planning. Next, endovascular occlusion is performed, with a preference for coiling or endoluminal reconstruction with a flow diverter. Last, endoscopic intervention follows in cases where: (1) decompression of vital structures is indicated; (2) diagnosis of the pseudoaneurysm cannot be definitively confirmed with angiography; or (3) the etiology of the confirmed pseudoaneurysm requires further investigation.

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Management of long-lasting phantosmia: a systematic review

Background

Interest in the pathophysiology and management of phantom smells has increased rapidly over the last decade. A PubMed search for the term "phantosmia" demonstrated a near-doubling of articles published on phantosmia within the past 7 years. We aimed to systematically review the literature on the management of phantosmia.

Methods

The PubMed, EMBASE, and Cochrane databases were searched for articles published since January 1990, using terms combined with pertinent Boolean search operators. We included articles evaluating management of phantosmia written in the English language, with original data and a minimum of 6 months of follow-up, on at least 2 patients and with well-defined and measurable outcomes.

Results

A total of 2151 unique titles were returned upon the initial search. Of these, 146 abstracts were examined, yielding 7 articles meeting the inclusion criteria. All articles were predominantly level 4 evidence. One prospective level 3 study was included. The studies included a total of 96 patients, with follow-up ranging from 6 months to 11 years. Endpoints were primarily based on subjective patient responses. Management options included observation and medical and surgical therapy. Olfactory mucosa excision was the only surgical intervention studied, with short-term symptomatic improvement in 10 of 11 patients. Forty-one patients were treated medically, which included antipsychotic, antimigraine, and antiseizure medications, transcranial stimulation, and topical cocaine application.

Conclusion

Despite increasing interest in the treatment of phantosmia and reports of successful therapies, there remains a paucity of data and lack of consensus regarding optimal management of this difficult condition.

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A challenge-response endoscopic sinus surgery specific checklist as an add-on to standard surgical checklist: an evaluation of potential safety and quality improvement issues

Background

The goal of this study was to develop and evaluate the impact of an aviation-style challenge and response sinus surgery–specific checklist on potential safety and equipment issues during sinus surgery at a tertiary academic health center. The secondary goal was to assess the potential impact of use of the checklist on surgical times during, before, and after surgery. This initiative is designed to be utilized in conjunction with the "standard" World Health Organization (WHO) surgical checklist. Although endoscopic sinus surgery is generally considered a safe procedure, avoidable complications and potential safety concerns continue to occur. The WHO surgical checklist does not directly address certain surgery-specific issues, which may be of particular relevance for endoscopic sinus surgery.

Methods

This prospective observational pilot study monitored compliance with and compared the occurrence of safety and equipment issues before and after implementation of the checklist. Forty-seven consecutive endoscopic surgeries were audited; the first 8 without the checklist and the following 39 with the checklist. The checklist was compiled by evaluating the patient journey, utilizing the available literature, expert consensus, and finally reevaluation with audit type cases. The final checklist was developed with all relevant stakeholders involved in a Delphi method.

Results

Implementing this specific surgical checklist in 39 cases at our institution, allowed us to identify and rectify 35 separate instances of potentially unsafe, improper or inefficient preoperative setup. These incidents included issues with labeling of topical vasoconstrictor or injectable anesthetics (3, 7.7%) and availability, function and/or position of video monitors (2, 5.1%), endoscope (6, 15.4%), microdebrider (6, 15.4%), bipolar cautery (6, 15.4%), and suctions (12, 30.8%).

Conclusion

The design and integration of this checklist for endoscopic sinus surgery, has helped improve efficiency and patient safety in the operating room setting.

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Do you know your guidelines? Diagnosis and management of cutaneous head and neck melanoma

Abstract

The following article is the next installment of the series "Do You Know Your Guidelines?" presented by the Education Committee of the American Head and Neck Society. Guidelines for the prevention, diagnosis, workup, and management of cutaneous melanoma are reviewed in an evidence-based fashion.

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Change in alcohol and tobacco consumption after a diagnosis of head and neck cancer: Findings from head and neck 5000

Abstract

Background

Tobacco and alcohol consumption are risk factors for developing head and neck cancer, and continuation postdiagnosis can adversely affect prognosis. We explored changes to these behaviors after a head and neck cancer diagnosis.

Methods

Demographic and clinical data were collected from 973 people newly diagnosed with oral cavity, oropharyngeal, or laryngeal cancer. Tobacco and alcohol consumption were additionally collected 4 and 12 months later.

Results

The prevalence of high alcohol consumption reduced from 54.3% at diagnosis to 41.4% at 12 months, and smoking reduced from 21.0% to 11.7%. Changes in behavior were dynamic, for example, 44% of smokers at 12 months were not smoking at diagnosis or 4 months. Several factors were associated with alcohol consumption, whereas only tumor site and comorbidities were associated with smoking.

Conclusion

A diagnosis of head and neck cancer can result in important changes in alcohol consumption and smoking prevalence. However, these changes are dynamic in the first year after diagnosis.

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Supine positioning for the subscapular system of flaps: A pictorial essay

Abstract

Background

This pictorial essay demonstrates a modification to the positioning, prepping, and draping technique for the subscapular system of flaps allowing the patient to be placed supine and without the need for a second assistant during the harvest or closure.

Methods and Results

We performed a literature review focusing on the positioning of the patient during the harvest of the subscapular system of flaps. A supine modification harvest prepping, draping, and position is then described in pictorial essay format. The technique is made possible with the use of a Mayo stand to position the arm.

Discussion

A literature review demonstrates limited description of nonlateral decubitus position harvest of the scapular flap. A novel positioning technique is described in pictorial essay format to demonstrate the ease and feasibility without the need for a second assistant during the case, an important goal in the era of limited resident duty hours.

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