Standard Fixed Enoxaparin Dosing for Venous Thromboembolism Prophylaxis Leads to Low Peak Anti-Factor Xa Levels in Both Head and Neck and Breast Free Flap Patients

INTRODUCTION: Venous thromboembolism (VTE) is a serious complication, particularly in cancer patients undergoing free flap reconstruction. Subcutaneous enoxaparin is the conventional prophylaxis for VTE prevention, and serum anti-factor Xa (afXa) levels are being increasingly used to monitor enoxaparin activity. In this study, free flap patients receiving standard enoxaparin prophylaxis were prospectively followed to investigate postoperative afXa levels and 90-day VTE and bleeding-related complications. METHODS: Patients undergoing free tissue transfer during an 8-month period were identified and prospectively followed. Patients received standard fixed enoxaparin dosing at 30 mg twice daily in head and neck (H&N) and 40 mg daily in breast reconstructions. Target peak prophylactic afXa range was 0.2 to 0.5 IU/mL. The primary outcome was the occurrence of 90-day postoperative VTE- and bleeding-related events. Independent predictors of afXa level and VTE incidence were analyzed for patients that met the inclusion criteria. RESULTS: Seventy-eight patients were prospectively followed. Four (5.1%) were diagnosed with VTE, and six (7.7%) experienced bleeding-related complications. The mean afXa levels in both VTE patients and bleeding patients were subprophylactic (0.13 ± 0.09 and 0.11 ± 0.07 IU/mL, respectively). Forty-six patients (21 breast, 25 H&N) had valid postoperative peak steady-state afXa levels. Among these, 15 (33%) patients achieved the target prophylactic range: 5 (33%) H&N and 10 (67%) breast patients. The mean afXa level for H&N patients was significantly lower than for breast patients (p = 0.0021). Patient total body weight was the sole negative predictor of afXa level (R (2) = 0.47, p \u3c 0.0001). CONCLUSION: Standard fixed enoxaparin dosing for postoperative VTE prophylaxis does not achieve target afXa levels for the majority of our free flap patients. H&N patients appear to be a particularly high-risk group that may require a more personalized and aggressive approach. Total body weight is the sole negative predictor of afXa level, supporting a role for weight-based enoxaparin dosing

Concordance between the Chang and the International Society of Pediatric Oncology (SIOP) ototoxicity grading scales in patients treated with cisplatin for medulloblastoma

BackgroundReporting ototoxicity is frequently complicated by use of various ototoxicity criteria. The International Society of Pediatric Oncology (SIOP) ototoxicity grading scale was recently proposed for standardized use in reporting hearing loss outcomes across institutions. The aim of this study was to evaluate the concordance between the Chang and SIOP ototoxicity grading scales. Differences between the two scales were identified and the implications these differences may have in the clinical setting were discussed.ProceduresAudiological evaluations were reviewed for 379 patients with newly diagnosed medulloblastoma (ages 3–21 years). Each patient was enrolled on one of two St. Jude clinical protocols that included craniospinal radiation therapy and four courses of 75 mg/m2 cisplatin chemotherapy. The latest audiogram conducted 5.5–24.5 months post-protocol treatment initiation was graded using the Chang and SIOP ototoxicity criteria. Clinically significant hearing loss was defined as Chang grade ≥2a and SIOP ≥2. Hearing loss was considered serious (requiring a hearing aid) at the level of Chang grade ≥2b and SIOP ≥3.ResultsA strong concordance was observed between the Chang and SIOP ototoxicity scales (Stuart\u27s tau-c statistic = 0.89, 95% CI: 0.86, 0.91). Among those patients diagnosed with serious hearing loss, the two scales were in good agreement. However, the scales deviated from one another in classifying patients with less serious or no hearing loss.ConclusionsAlthough discrepancies between the Chang and SIOP ototoxicity scales exist primarily for patients with no or minimal hearing loss, the scales share a strong concordance overall. Pediatr Blood Cancer 2014;61:601–605. © 2013 Wiley Periodicals, Inc

Concordance between the chang and the International Society of Pediatric Oncology (SIOP) ototoxicity grading scales in patients treated with cisplatin for medulloblastoma

Background: Reporting ototoxicity is frequently complicated by use of various ototoxicity criteria. The International Society of Pediatric Oncology (SIOP) ototoxicity grading scale was recently proposed for standardized use in reporting hearing loss outcomes across institutions. The aim of this study was to evaluate the concordance between the Chang and SIOP ototoxicity grading scales. Differences between the two scales were identified and the implications these differences may have in the clinical setting were discussed. Procedures: Audiological evaluations were reviewed for 379 patients with newly diagnosed medulloblastoma (ages 3-21 years). Each patient was enrolled on one of two St. Jude clinical protocols that included craniospinal radiation therapy and four courses of 75mg/m2 cisplatin chemotherapy. The latest audiogram conducted 5.5-24.5 months post-protocol treatment initiation was graded using the Chang and SIOP ototoxicity criteria. Clinically significant hearing loss was defined as Chang grade ≥2a and SIOP ≥2. Hearing loss was considered serious (requiring a hearing aid) at the level of Chang grade ≥2b and SIOP ≥3. Results: A strong concordance was observed between the Chang and SIOP ototoxicity scales (Stuart\u27s tau-c statistic=0.89, 95% CI: 0.86, 0.91). Among those patients diagnosed with serious hearing loss, the two scales were in good agreement. However, the scales deviated from one another in classifying patients with less serious or no hearing loss. Conclusions: Although discrepancies between the Chang and SIOP ototoxicity scales exist primarily for patients with no or minimal hearing loss, the scales share a strong concordance overall. Pediatr Blood Cancer 2014;61:601-605. © 2013 Wiley Periodicals, Inc

Examining the relationship of immunotherapy and wound complications following flap reconstruction in patients with head and neck cancer

BackgroundImmunotherapy agents are used to treat advanced head and neck lesions. We aim to elucidate relationship between immunotherapy and surgical wound complications.MethodsRetrospective multi‐institutional case series evaluating patients undergoing ablative and flap reconstructive surgery and immunotherapy treatment. Main outcome: wound complications.ResultsEight‐two (62%) patients received preoperative therapy, 89 (67%) postoperative, and 33 (25%) in both settings. Forty‐one (31%) patients had recipient site complications, 12 (9%) had donor site. Nineteen (14%) had major recipient site complications, 22 (17%) had minor. There was no statistically significant difference in complications based on patient or tumor‐specific variables. Preoperative therapy alone demonstrated increased major complications (odds ratio [OR] 3.7, p = 0.04), and trend to more donor site complications (OR 7.4, p = 0.06), however treatment in both preoperative and postoperative therapy was not.ConclusionsPreoperative immunotherapy may be associated with increased wound complications. Controlled studies are necessary to delineate this association and potential risks of therapy.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/167524/1/hed26601_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/167524/2/hed26601.pd

Consensus of free flap complications: Using a nomenclature paradigm in microvascular head and neck reconstruction

BackgroundWe aim to define a set of terms for common free flap complications with evidence‐based descriptions.MethodsClinical consensus surveys were conducted among a panel of head and neck/reconstructive surgeons (N = 11). A content validity index for relevancy and clarity for each item was computed and adjusted for chance agreement (modified kappa, K). Items with K < 0.74 for relevancy (i.e., ratings of “good” or “fair”) were eliminated.ResultsFive out of nineteen terms scored K < 0.74. Eliminated terms included “vascular compromise”; “cellulitis”; “surgical site abscess”; “malocclusion”; and “non‐ or mal‐union.” Terms that achieved consensus were “total/partial free flap failure”; “free flap takeback”; “arterial thrombosis”; “venous thrombosis”; “revision of microvascular anastomosis”; “fistula”; “wound dehiscence”; “hematoma”; “seroma”; “partial skin graft failure”; “total skin graft failure”; “exposed hardware or bone”; and “hardware failure.”ConclusionStandardized reporting would encourage multi‐institutional research collaboration, larger scale quality improvement initiatives, the ability to set risk‐adjusted benchmarks, and enhance education and communication.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/170285/1/hed26789.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/170285/2/hed26789_am.pd