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Transoral robotic surgery adoption and safety in treatment of oropharyngeal cancers

Oliver, Jamie R; Persky, Michael J; Wang, Binhuan; Duvvuri, Umamaheswar; Gross, Neil D; Vaezi, Alec E; Morris, Luc G T; Givi, Babak
BACKGROUND:Transoral robotic surgery (TORS) was approved by the Food and Drug Administration in 2009 for the treatment of oropharyngeal cancers (oropharyngeal squamous cell carcinoma [OPSCC]). This study investigated the adoption and safety of TORS. METHODS:All patients who underwent TORS for OPSCC in the National Cancer Data Base from 2010 to 2016 were selected. Trends in the positive margin rate (PMR), 30-day unplanned readmission, and early postoperative mortality were evaluated. Outcomes after TORS, nonrobotic surgery (NRS), and nonsurgical treatment were compared with matched-pair survival analyses. RESULTS:From 2010 to 2016, among 73,661 patients with OPSCC, 50,643 were treated nonsurgically, 18,024 were treated with NRS, and 4994 were treated with TORS. TORS utilization increased every year from 2010 (n = 363; 4.2%) to 2016 (n = 994; 8.3%). The TORS PMR for base of tongue malignancies decreased significantly over the study period (21.6% in 2010-2011 vs 15.8% in 2015-2016; P = .03). The TORS PMR at high-volume centers (≥10 cases per year; 11.2%) was almost half that of low-volume centers (<10 cases per year; 19.3%; P < .001). The rates of 30-day unplanned readmission (4.1%) and 30-day postoperative mortality (1.0%) after TORS were low and did not vary over time. High-volume TORS centers had significantly lower rates of 30-day postoperative mortality than low-volume centers (0.5% vs 1.5%; P = .006). In matched-pair analyses controlling for clinicopathologic cofactors, 30-, 60-, and 90-day posttreatment mortality did not vary among patients with OPSCC treated with TORS, NRS, or nonsurgical treatment. CONCLUSIONS:TORS has become widely adopted and remains safe across the country with a very low risk of severe complications comparable to the risk with NRS. Although safety is excellent nationally, high-volume TORS centers have superior outcomes with lower rates of positive margins and early postoperative mortality.
PMID: 34762303
ISSN: 1097-0142
CID: 5050682

Improving Quality and Safety of Thyroidectomy [Meeting Abstract]

Papazian, M; Roland, J T; Shao, Q; Vaezi, A; DeLacure, M; Tran, T; Persky, M J; Persky, M S; Jacobson, A; Givi, B
Introduction: Thyroidectomy is commonly performed in otolaryngology. Complications such as recurrent laryngeal nerve (RLN) injury and severe hypocalcemia have reported incidences in national studies as high as 3% and 8%, respectively. Narcotic pain medications are commonly used for postoperative pain management. Here, we present the long-term results of a thyroidectomy quality and safety improvement program, with an emphasis on reducing narcotic use.
Method(s): All surgeons who perform thyroidectomy established standards for antibiotic administration, postoperative calcium management, and narcotics use. The program was established in 2018 and data on adverse events, length of stay, antibiotic and narcotic use were recorded prospectively from June 2018 to January 2021. Data trends were analyzed throughout the course of the study.
Result(s): During the study period, 542 thyroidectomies were performed by 14 surgeons. The average length of stay was less than 24 hours. Five (0.9%) adverse events were recorded: 1 (0.2%) temporary RLN dysfunction, 3 (0.6%) hematomas, 1 (0.2%) surgical site infection, and 1 (0.2%) temporary hypocalcemia. The average number of narcotics prescribed declined from 18 doses (95%CI: 16.8-18.5) in 2019 to 9 in 2020 (95%CI: 8.5-9.6) (p<0.0001), without an increase in need for refills. No instances of permanent hypocalcemia or permanent RLN injury were identified.
Conclusion(s): By implementing a thyroidectomy quality improvement program, we achieved extremely low rates of adverse events and significantly reduced the use of narcotics without adverse effects. These data can inform practitioners and the public about expected outcomes of thyroid surgery, and establish benchmarks for quality and safety.
ISSN: 1879-1190
CID: 5024602

Shared Decision-making and Stakeholder Engagement in COVID-19 Tracheostomy-Reply

Kwak, Paul E; Persky, Michael J; Amin, Milan R
PMID: 33764364
ISSN: 2168-619x
CID: 4875412

Radiotherapy in Metastatic Oropharyngeal Cancer

Nguy, Susanna; Oh, Cheongeun; Karp, Jerome M; Wu, Shengyang Peter; Li, Zujun; Persky, Michael J; Hu, Kenneth S; Givi, Babak; Tam, Moses M
OBJECTIVES/OBJECTIVE:The role of locoregional radiotherapy for metastatic oropharyngeal squamous cell cancer (OPSCC) is unclear. We investigated the impact of head and neck radiotherapy on survival in de novo metastatic OPSCC patients who received systemic therapy. METHODS:We queried the NCDB from 2004-2015 for metastatic OPSCC patients at diagnosis with known HPV-status who received systemic therapy. The association of head and neck radiotherapy with overall survival was analyzed using the Kaplan-Meier method, Cox proportional hazards model, and propensity score-matched analysis adjusting for demographic and disease-specific prognostic factors. RESULTS:Of the 2,139 patients with metastatic OPSCC who presented with metastases and received systemic treatment, we identified 556 patients with known HPV-status. Among these 556 patients, 49% were HPV-positive and 56% received head and neck radiotherapy. With a median follow-up of 17.5 months (IQR 6.0-163.4 months), radiotherapy was associated with significantly improved 1-year OS (67% vs 58%, log-rank P < .001) which remained significant on MVA (HR 0.78 95% CI 0.62-0.97 P = .029). In HPV-status subgroup analysis, a survival benefit was identified in HPV-positive patients (1-year OS 77% vs 67%, log-rank P < .001) but not in HPV-negative patients. Results were consistent on a propensity score-matched analysis of 212 HPV-positive matched patients (HR 0.66, 95% CI 0.49-0.83, P < .001). CONCLUSION/CONCLUSIONS:The survival of metastatic OPSCC remains limited. In this large series of patients with known HPV-status, head and neck radiotherapy was associated with longer survival in those with HPV-associated disease. These data could guide management of this challenging group of patients for head and neck cancer practitioners. LEVEL OF EVIDENCE/METHODS:3 Laryngoscope, 2020.
PMID: 33141455
ISSN: 1531-4995
CID: 4662912

Early Outcomes From Early Tracheostomy for Patients With COVID-19

Kwak, Paul E; Connors, Joseph R; Benedict, Peter A; Timen, Micah R; Wang, Binhuan; Zhang, Yan; Youlios, Stephanie; Sureau, Kimberly; Persky, Michael J; Rafeq, Samaan; Angel, Luis; Amin, Milan R
Importance/UNASSIGNED:Decision-making in the timing of tracheostomy in patients with coronavirus disease 2019 (COVID-19) has centered on the intersection of long-standing debates on the benefits of early vs late tracheostomy, assumptions about timelines of infectivity of the novel coronavirus, and concern over risk to surgeons performing tracheostomy. Multiple consensus guidelines recommend avoiding or delaying tracheostomy, without evidence to indicate anticipated improvement in outcomes as a result. Objective/UNASSIGNED:To assess outcomes from early tracheostomy in the airway management of patients with COVID-19 requiring mechanical ventilation. Design, Setting, and Participants/UNASSIGNED:A retrospective medical record review was completed of 148 patients with reverse transcriptase-polymerase chain reaction-confirmed COVID-19 requiring mechanical ventilation at a single tertiary-care medical center in New York City from March 1 to May 7, 2020. Interventions/UNASSIGNED:Open or percutaneous tracheostomy. Main Outcomes and Measures/UNASSIGNED:The primary outcomes were time from symptom onset to (1) endotracheal intubation, (2) tracheostomy; time from endotracheal intubation to tracheostomy; time from tracheostomy to (1) tracheostomy tube downsizing, (2) decannulation; total time on mechanical ventilation; and total length of stay. Results/UNASSIGNED:Participants included 148 patients, 120 men and 28 women, with an overall mean (SD) age of 58.1 (15.8) years. Mean (SD; median) time from symptom onset to intubation was 10.57 (6.58; 9) days; from symptom onset to tracheostomy, 22.76 (8.84; 21) days; and from endotracheal intubation to tracheostomy, 12.23 (6.82; 12) days. The mean (SD; median) time to discontinuation of mechanical ventilation was 33.49 (18.82; 27) days; from tracheostomy to first downsize, 23.02 (13.76; 19) days; and from tracheostomy to decannulation, 30.16 (16.00; 26) days. The mean (SD; median) length of stay for all patients was 51.29 (23.66; 45) days. Timing of tracheostomy was significantly associated with length of stay: median length of stay was 40 days in those who underwent early tracheostomy (within 10 days of endotracheal intubation) and 49 days in those who underwent late tracheostomy (median difference, -8; 95% CI, -15 to -1). In a competing risks model with death as the competing risk, the late tracheostomy group was 16% less likely to discontinue mechanical ventilation (hazard ratio, 0.84; 95% CI, 0.55 to 1.28). Conclusions and Relevance/UNASSIGNED:This cohort study from the first 2 months of the pandemic in New York City provides an opportunity to reconsider guidelines for tracheostomy for patients with COVID-19. Findings demonstrated noninferiority of early tracheostomy and challenges recommendations to categorically delay or avoid tracheostomy in this patient population. When aligned with emerging evidence about the timeline of infectivity of the novel coronavirus, this approach may optimize outcomes from tracheostomy while keeping clinicians safe.
PMID: 33331855
ISSN: 2168-619x
CID: 4718022

Primary Surgical Treatment in Very Advanced (T4b) Oral Cavity Squamous Cell Carcinomas

Patel, Evan J; Oliver, Jamie R; Vaezi, Alec; Li, Zujun; Persky, Michael; Tam, Moses; Hu, Kenneth S; Jacobson, Adam S; Givi, Babak
OBJECTIVES/OBJECTIVE:To describe patterns of primary surgical treatments in patients with T4b oral cavity squamous cell carcinoma (OCSCC). STUDY DESIGN/METHODS:Historical cohort study. SETTING/METHODS:National Cancer Database. METHODS:Review of the National Cancer Database between 2004 and 2017 for all T4b OCSCCs. Only patients with curative treatment methods were included in the survival analysis. Surgical and nonsurgical outcomes were compared by multivariable and propensity score matching analysis. RESULTS:= .20). CONCLUSIONS:A minority of patients with T4b OCSCC undergo treatments with curative intent. A subset of patients underwent primary surgical treatment, which was associated with longer survival. The T4b classification might entail a heterogenous group, and further studies in revision of this classification might be justified.
PMID: 33400630
ISSN: 1097-6817
CID: 4738772

The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer

Van Cleave, Janet H; Fu, Mei R; Bennett, Antonia V; Concert, Catherine; Riccobene, Ann; Tran, Anh; Most, Allison; Kamberi, Maria; Mojica, Jacqueline; Savitski, Justin; Kusche, Elise; Persky, Mark S; Li, Zujun; Jacobson, Adam S; Hu, Kenneth S; Persky, Michael J; Liang, Eva; Corby, Patricia M; Egleston, Brian L
Background/UNASSIGNED:Patients with head and neck cancer (HNC) experience painful, debilitating symptoms and functional limitations that can interrupt cancer treatment, and decrease their health-related quality of life (HRQoL). The Electronic Patient Visit Assessment (ePVA) for head and neck is a web-based mHealth patient-reported measure that asks questions about 21 categories of symptoms and functional limitations common to HNC. This article presents the development and usefulness of the ePVA as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. Methods/UNASSIGNED:Between January 2018 and August 2019, 75 participants were enrolled in a clinical usefulness study of the ePVA. Upon signing informed consent, participants completed the ePVA and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) general (C30) questionnaire v3.0 (scores range from 0 to 100 with 100 representing best HRQoL). Clinical usefulness of the ePVA was defined as demonstration of reliability, convergent validity with HRQoL, and acceptability of the ePVA (i.e., >70% of eligible participants complete the ePVA at two or more visits and >70% of ePVA reports are read by providers). Formal focus group discussions with the interdisciplinary team that cared for patients with HNC guided the development of the ePVA as a clinical support tool. Qualitative and quantitative methods were used throughout the study. Descriptive statistics consisting of means and frequencies, Pearson correlation coefficient, and Student's t-tests were calculated using SAS 9.4 and STATA. Results/UNASSIGNED:The participants were primarily male (71%), White (76%), diagnosed with oropharyngeal or oral cavity cancers (53%), and undergoing treatment for HNC (69%). Data analyses supported the reliability (alpha =0.85), convergent validity with HRQoL scores, and acceptability of the ePVA. Participants with the highest number of symptoms and functional limitations reported significantly worse HRQoL (sum of symptoms: r=-0.50, P<0.0001; sum of function limitations: r=-0.56, P<0.0001). Ninety-two percent of participants (59 of 64) who had follow-up visits within the 6-month study period completed the ePVA at two or more visits and providers read 89% (169 of 189) of automated ePVA reports. The use of the ePVA as a clinical support tool for real-time interventions for symptoms and functional limitations reported by patients is described in a clinical exemplar. Conclusions/UNASSIGNED:This research indicates that the ePVA may be a useful mHealth tool as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. The study findings support future translational research to enhance the usefulness of the ePVA in real world settings for early interventions that decrease symptom burden and improve the QoL of patients with HNC.
PMID: 33634190
ISSN: 2306-9740
CID: 4795022

Oral Squamous Cell Carcinoma as a Complication of Treatment for Recurrent High-Grade Serous Cancer

Moses, Lindsey E; Rotsides, Janine M; Balogun, Fiyinfolu O; Persky, Mark S; Muggia, Franco M; Persky, Michael J
OBJECTIVES/HYPOTHESIS/OBJECTIVE:Advances in cancer treatment have increased survival for many patients, prompting a need for greater recognition of the long-term complications of treatment. Chemotherapy agents have the potential to induce carcinogenesis and can increase the risk of secondary malignancy. Pegylated liposomal doxorubicin (PLD) used for maintenance treatment of recurrent high-grade serous cancers has been associated with the development of oral cavity squamous cell carcinoma (SCC). STUDY DESIGN/METHODS:Retrospective review. METHODS:Cases of oral cavity SCC in patients with recurrent high-grade serous cancer treated with PLD between 1997 and 2017 at a single institution were reviewed. RESULTS:). Seven patients tested positive for BRCA mutations (four BRCA 1+, three BRCA 2+). No patients had a history of alcohol or tobacco use. All had early-stage oral cavity disease; five were T1N0, two were T2N0, and one had carcinoma in situ. All patients underwent surgery, and two received adjuvant radiation. Four developed locoregional recurrence requiring additional treatment. Of these, one patient died from complications of oral SCC, one developed recurrent ovarian cancer, and two had no evidence of disease of the oral cavity or ovarian cancer at the last follow-up. CONCLUSIONS:Long-term PLD therapy may be associated with the development of oral cavity SCC. A high index of suspicion and routine head and neck examination should be included in follow-up for exposed patients. LEVEL OF EVIDENCE/METHODS:4 Laryngoscope, 2019.
PMID: 31800100
ISSN: 1531-4995
CID: 4218622

Tracheostomy in COVID-19 Patients: Why Delay or Avoid? [Letter]

Kwak, Paul E; Persky, Michael J; Angel, Luis; Rafeq, Samaan; Amin, Milan R
PMID: 32808866
ISSN: 1097-6817
CID: 4566762

Trimodality Treatment of Very Locally Advanced Sinonasal Cancer: A National Cancer Database Analysis [Meeting Abstract]

Karp, J. M.; Hu, K. S.; Persky, M.; Jacobson, A.; Tran, T.; Li, Z.; Givi, B.; Tam, M.
ISSN: 0360-3016
CID: 4686342