Predictors of Averse Events After Total Laryngectomy: An Analysis of the 2005-2011 NSQIP Datasets

Background: We reviewed the 2005-2011 ACS-NSQIP database to evaluate factors associated with adverse events (AE) after total laryngectomy (TL). Methods: All total laryngectomies performed from 2006 to 2011 were identified for analysis. The cohort was characterized with respect to preoperative and demographic characteristics, complications, reoperation, and mortality. Results: 493 cases were identified. Complications of any category occurred in 189 cases (38.3%). Factors that were found to confer significant risk for medical complications were increased age [Odds Ratio (OR) 1.03], prior PCI (OR 2.84), disseminated cancer (OR 2.47), chronic steroid/immunosuppresion use (OR 2.87), unintended weight loss > 10% over 6 months prior to surgery (OR 2.02), increasing work RVU total (OR 1.02), and increased anesthesia Z-score (OR 1.31). Only increased anesthesia Z-score (OR 1.27) was found to be a statistically significant risk factor for surgical complications. Chronic steroid/immunosuppression use (OR 3.16) and increased anesthesia Z-score (OR 1.29) were both found to be statistically significant risk factors of reoperation within 30 days. Conclusions: NSQIP is the only dataset that correctly discerns between minimally invasive and wide excision in laryngectomy. The use of the NSQIP dataset may be imperfect, as pertinent details of chemotherapy and radiation, and procedure-specific complications, including fistula formation, are not tracked. In spite of this, our findings suggest avenues for improvement in the care of TL patients, and suggest directions for a laryngectomy-specific outcomes database. DOI : 10.14302/issn.2379-8572.joa-14-429 Corresponding Author: Jon P Ver Halen, MD, FACS Division of Plastic and Reconstructive Surgery, Baptist Cancer Center; Department of Surgery, St. Jude Childrens’ Research Hospital; Department of Surgical Oncology, Vanderbilt-Ingram Cancer Center 3268 Duke Circle, Germantown, TN 38139 Email: jpverhalen@gmail.com Tel: (206) 963-8714 Fax: (901) 227-9825 Running Head: Tracking laryngectomy using NSQIP


Introduction
The care of patients with laryngeal cancer has changed dramatically in the last two decades.. In 1991, the VA Laryngeal Cancer Study Group showed equivalent survival among patients undergoing laryngectomy versus chemoradiation. Subsequently, the use of primary chemoradiation in patients with advanced laryngeal cancer significantly increased, relative to the use of primary total laryngectomy. [1][2][3][4] Total laryngectomy is now used more often as a salvage procedure after chemoand/or radiation therapy. 4 Salvage surgery has a lower rate of survival after the failure of organ preservation, and has a well-established increased rate of complications. [4][5][6][7][8][9] In addition, the rate of postoperative fistula has increased from 52% to 84% over the past two decades. Wound healing complications and inhospital death are significantly higher in patients undergoing pedicled or free-flap reconstruction, and in patients with advanced comorbidities. 7,10-12 Prior radiation has also been found to be associated with increased rates of 30-day mortality. 4 The National Cancer Database (NCDB),

Database (SEER), Department of Veterans Affairs
National Quality Improvement registry (VA NSQIP), Nationwide Inpatient Sample database, and singleinstitution databases have all been used to determine factors responsible for undesirable outcomes in laryngectomy patients. 7 Our aim was to compare this data to that derived from the American College of both found to be statistically significant risk factors of reoperation within 30 days. This is represented in Table   6. All p values reached significance at less than 0.05.

Discussion
Although some surgical complications might be preventable, many are inherent risks associated with the procedure and are associated with safe management. Therefore, defining preventable or unnecessary adverse events is a challenge to ensure fair measurements of quality. Thirty-day adverse events, including complications, unplanned reoperation, and unplanned hospital readmissions represent a large financial burden to insurance payors, hospitals, and individual patients.
In addition, they are increasingly surveyed as an indicator for health care quality, hospital performance, and a potential target for cost-containment. 16 It has been estimated that approximately $15 billion is spent on the 17.6% of patients who are readmitted within 30    There were no preoperative characteristics specifically associated with 30-day mortality.
The sum of the relative value units (RVUs) was used to evaluate for the added complexity and risk of concurrent procedures, as has been described previously. 19 RVUs reflect the relative level of time, skill, training and intensity required of a physician to provide a given service. RVUs therefore are a method for calculating the volume of work or effort expended by a physician in treating patients, and are set by CMS in association with a physician advisory council. For a patient undergoing multiple procedures, the respective RVU's can be summed to estimate the total complexity of a given set of procedures (e.g., laryngectomy + free flap reconstruction + tracheostomy + feeding tube in a patient undergoing laryngectomy as one of multiple procedures). Given the heterogeneity of procedures identified in NSQIP, total work RVU is the best way to assess for the overall complexity of a given set of procedures performed on a patient in one setting.
Previous studies have suggested that concomitant neck dissection and/or flap reconstruction with laryngectomy is associated with increased complications, although these findings are controversial. 7,10-12 The use of RVU total, as in our study, is a much more appropriate measure of the overall magnitude of a given operation.
Our findings further support the relationship between increasing surgical complexity with increased AE's in patients undergoing TL. In spite of this, our findings provide data for improved patient care, and suggest directions for a laryngectomyspecific outcomes database.

Financial Support:
This particular research received no internal or external grant funding.

Conflicts of Interest:
The authors report no relevant financial disclosures related to this current work.