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Background: Decisions about stroke prevention strategies in atrial fibrillation (AF) typically balance thromboembolism reduction against increased bleeding from oral anticoagulation therapy (OAC). When determining eligibility for OAC, guidelines recommend calculation of thromboembolic event rates using a validated score such as CHA2DS2-VASc. In contrast, routine calculation of bleeding scores is not recommended, in part because many patient factors associated with an increased risk of bleeding are associated with an even larger increased risk of ischemic stroke. We set out to characterize patients by paired stroke and bleeding risk scores to understand the level of concordance., Methods: Between 2010 and 2016, we identified 20,451 AF patients in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) I and II Registries. We grouped patients by stroke and bleeding risk pairings: low and high stroke risk (CHA2DS2-VASc < and ≥2), low and high bleeding risk (ORBIT < and ≥ 4) and described treatment rates with OAC and antiplatelet (AP) therapy., Results: Most patients (68.6 %) were at high stroke and low bleeding risk. Patients at high bleeding risk (19.4 %) had high stroke risk (98.5 %). Treatment rates differed with combined OAC + AP therapy highest for patients at high stroke and bleeding risks. Ischemic and bleeding events were also highest in this group., Conclusions: Nearly all AF patients in this cohort with high bleeding risk (ORBIT score ≥ 4) had high stroke risk (CHA2DS2-VASc ≥ 2), supporting that bleeding risk should not obviate the need for stroke prevention. In contrast, most at high stroke risk were at low bleeding risk (ORBIT <4), supporting OAC for the majority. Bleeding scores, in combination with factors that specifically indicate a higher risk of bleeding, may identify patients who might be candidates for alternative stroke prevention such as left atrial appendage occlusion devices or bleeding mitigation strategies such as de-escalation of antiplatelet therapy., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Importance: Oral and oropharyngeal cancer have low survival rates, and incidence continues to increase., Objective: To determine whether soluble CD44 and total protein (TP) are useful for monitoring head and neck cancer recurrence, either used in a point-of-care (POC) test or as individual laboratory-based biomarkers., Design, Setting, and Participants: This multi-institutional nonrandomized clinical trial testing a novel diagnostic/screening assay took place across the University of California, San Diego; Johns Hopkins University; the Greater Baltimore Medical Center; New York University; and the San Diego Veterans Affairs Hospital. Patients with newly biopsy-proven, untreated oral cavity and oropharyngeal cancer were enrolled. Patients were enrolled April 2017 to April 2019, and data were analyzed December 2022 to June 2023., Exposure: POC salivary oral rinse test., Main Outcomes and Measures: Oral rinses were collected at pretreatment baseline and 3, 6, 12, and 18 months after completion of therapy; participants were then followed up for 3 years to define disease status. Associations of baseline characteristics with a positive test were evaluated by Fisher exact test. The association of a positive value on the CD44 or TP test with progression-free survival was evaluated in an adjusted multivariable proportional hazards model., Results: Of 172 patients enrolled, the mean (SD) age was 62.5 (10.2) years, and 122 (70.9%) identified as male. Additionally, 92 patients (53.3%) had never smoked, 99 (57.6%) formerly or currently drank alcohol, and 113 (65.7%) presented with oropharyngeal cancers, which were positive for human papillomavirus in 95 (84.1%). Tumor site was associated with test results at baseline; patients with oral cavity cancer had a higher baseline positive POC test rate (47 of 51 [92.2%]) compared to patients with oropharyngeal cancer (85 of 110 [77.3%]). Using Cox regression models with CD44 or TP level as a time-varying covariate, a higher CD44 level showed a statistically significant association with a higher hazard of recurrence (hazard ratio, 1.06; 95% CI, 1.00-1.12), though the TP level was not statistically significant. In multivariate adjusted analysis, higher CD44 and TP levels were associated with increased hazard ratios of recurrence of 1.13 (95% CI, 1.04-1.22) and 3.51 (95% CI, 1.24-9.98), respectively., Conclusion and Relevance: In this multi-institutional nonrandomized clinical trial of an assay, posttreatment longitudinal monitoring for elevated salivary CD44 and TP levels using an enzyme-linked immunosorbent assay-based laboratory test identified patients at increased risk of future cancer recurrence. The CD44 and TP rapid POC test holds some promise, but further development is needed for this indication., Trial Registration: ClinicalTrials.gov Identifier: NCT03148665.

Though postpartum family planning helps women to achieve the recommended birth interval before next pregnancy, its utilization in Ethiopia is low. Understanding drivers and barriers is key to improve postpartum family planning uptake. The aim of this systematic review and meta-analysis is to analyze and summarize predictors of postpartum family planning uptake, during the first year after birth, in Ethiopia. We conducted a systematic review and meta-analysis of observational studies published in English before April 16, 2021. We searched electronic sources like PubMed, MEDLINE, CINHAL Embase, Google and supplemented it with manual search. Two reviewers appraised independently the studies using the Joanna Briggs Institute Quality Assessment Tool for the observational studies. Data synthesis and analysis were conducted using Review Manager Version 5.3. The Cochrane Q test statistic and I2 tests were used to assess the heterogeneity among the included studies. A random-effects and fixed effect model were used to calculate pooled Odds Ratio and its 95% CI. A total of 22 studies were included in the review. Better educational status of women[OR = 2.60; 95% CI: 2.15, 3.14], women's marital status [OR = 4.70; 95% CI: 1.51, 14.60], resumption of sexual intercourse [OR = 6.22; 95% CI: 3.01, 12.86], menses return [OR = 3.72; 95% CI: 1.98, 6.99], PPFP discussion with partner [OR = 2.53; 95% CI: 2.00, 3.20], women's previous PPFP information [OR = 4.93; 95% CI: 2.26, 10.76], PPFP counseling during ANC [OR = 3.95; 95% CI: 2.50, 6.23], having PNC [OR = 4.22; 95% CI: 2.80, 6.34], having experience of modern contraceptive use [OR = 2.90; 95% CI: 1.62, 5.19], facility birth [OR = 6.70; 95% CI: 3.15, 14.25], and longer interval after last delivery [OR = 0.37; 95% CI: 0.32, 0.43] were significantly associated with modern contraceptive uptake during postpartum period. Our systematic review identified modifiable factors and estimated their association with PPFP uptake. Since most of these factors are related to reproductive health characteristics and MNCH services, integrating PPFP into MNCH services particularly at primary health care unit may improve contraceptive uptake during postpartum period. Systematic review registration: PROSPERO: 2020: CRD42020159470., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Jima et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Oral anticoagulation (OAC) reduces the risk of thromboembolic events in patients with atrial fibrillation (AF); however, thromboembolism (TE) still can occur despite OAC. Factors associated with residual risk for stroke, systemic embolism, or transient ischemic attack events despite OAC have not been well described., Objective: The purpose of this study was to evaluate the residual risk of thromboembolic events in patients with AF despite OAC., Methods: A total of 18,955 patients were analyzed in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF I and II) using multivariable Cox proportional hazard modeling. Mean age was 72 ± 10.7, and 42% were women. There were 451 outcome events., Results: The risk of TE despite OAC increased with CHA 2 DS 2 -VASc score: 0.76 (95% confidence interval [CI] 0.63-0.92) events per 100 patient-years for CHA 2 DS 2 -VASc score <4 vs 2.01 (95% CI 1.81-2.24) events per 100-patient years for CHA 2 DS 2 -VASc score >4. Factors associated with increased risk were previous stroke or transient ischemic attack (hazard ratio [HR] 2.87; 95% CI 2.30-3.59; P <.001), female sex (HR 1.52; 95% CI 1.24-1.86; P <.001), hypertension (HR 1.50; 95% CI 1.09-2.06; P = .01), and permanent AF (HR 1.47; 95% CI 1.12-1.94; P = .001). When transient ischemic attack was excluded, the results were similar, but permanent AF was no longer significantly associated with thromboembolic events., Conclusion: Patients with AF have a residual risk of TE with increasing CHA 2 DS 2 -VASc score despite OAC. Key risk markers include previous stroke/transient ischemic attack, female sex, hypertension, and permanent AF., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Background and Purpose: Mandibulectomy remains the treatment of choice for oral cavity squamous cell carcinoma with infiltration of bone and for benign tumors with full mandibular thickness involvement. Although bone resection margins are critical for patient outcomes, intraoperative immediate bone margins assessment is inadequate, and few alternative options have been described. The purpose of this study was to describe the use of an existing intraoperative radiographic system for objective determination of bone resection margins during mandibulectomy., Methods: We conducted a retrospective case series of all patients at the Greater Baltimore Medical Center who underwent mandibulectomy and received intraoperative Faxitron radiography from January 1, 2016, to March 1, 2019. Patient characteristics including age, sex, diagnosis, tumor location, clinical and pathologic stage, procedure performed, and bone resection margins were reviewed., Results: A total of 10 patients underwent mandibulectomy with intraoperative radiography. Nine (90%) received surgery for squamous cell carcinoma, with 1 (10%) for ameloblastoma. Out of those with squamous cell carcinoma, tumor location varied, and all were clinically stage T4. Final pathologic margins were negative in all cases (10/10), though in 2 cases, close margins were assessed intraoperatively, leading to further resection or change in operative plan., Conclusion: Intraoperative radiographic assessment of bone resection margins is a promising technique, though further validation is required.

Objective: Non-vitamin K oral anticoagulants (NOACs) require dose adjustment for renal function. We sought to investigate change in renal function over time in patients with atrial fibrillation (AF) and whether those on NOACs have appropriate dose adjustments according to its decline., Methods: We included patients with AF enrolled in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry treated with oral anticoagulation. Worsening renal function (WRF) was defined as a decrease of >20% in creatinine clearance (CrCl) from baseline. The US Food and Drug Administration (FDA)-approved package inserts were used to define the reduction criteria of NOACs dosing., Results: Among 6682 patients with AF from 220 sites (median age (25th, 75th): 72.0 years (65.0, 79.0); 57.1% male; median CrCl at baseline: 80.1 mL/min (57.4, 108.5)), 1543 patients (23.1%) experienced WRF with mean decline in CrCl during 2 year follow-up of -6.63 mL/min for NOACs and -6.16 mL/min for warfarin. Among 4120 patients on NOACs, 154 (3.7%) patients had a CrCl decline sufficient to warrant FDA-recommended dose reductions. Of these, NOACs dosing was appropriately reduced in only 31 (20.1%) patients. Compared with patients with appropriately reduced NOACs, those without were more likely to experience bleeding complications (major bleeding: 1.7% vs 0%; bleeding hospitalisation: 2.6% vs 0%) at 1 year., Conclusions: In the US practice, about one-fourth of patients with AF had >20% decline in CrCl over time during 2 year follow-up. As a result, about 3.7% of those treated with NOACs met guideline criteria for dose reduction, but of these, only 20.1% actually had a reduction., Competing Interests: Competing interests: TI: Research Grant from Boston Scientific. LA: Contract with Janssen and Novartis. GF: Consultant/Advisory Board support from Janssen Pharmaceuticals. BJG: Member of a Data Safety Monitoring Board for Mount Sinai St. Lukes, Boston Scientific Corporation, Teva Pharmaceutical Industries, St. Jude Medical, Janssen Research & Development, Baxter Healthcare Corporation and Cardiovascular Research Foundation. Consultant/Advisory Board for Janssen Scientific Affairs, Cipla Limited, Armetheon Inc and Medtronic. EMH: Consultant: Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi-Sankyo, Johnson & Johnson; Research Grant from Bristol-Myers Squibb/Pfizer, Johnson & Johnson. MDE: Consultant/Advisory Board for Boehringer Ingelheim, Daiichi-Sankyo, Pfizer, Bristol-Myers Squibb and Janssen Scientific Affairs. PRK: Consultant for Johnson & Johnson. JAR: Research support from Janssen Pharmaceuticals and Medtronic Inc. Consultancies with Medtronic Inc, Acesion Pharma Aps, and Correvio Pharma Corp. GN: Research Grant from Janssen. Consultant/Advisory Board for Janssen and Daiichi-Sankyo. PC: Employee of Janssen. Consultant for Optum Rx and Johnson & Johnson. KWM: Financial disclosures can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey. DES: Consultant/Advisory Board for Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Johnson & Johnson, Pfizer and Medtronic. Research Grants from Boehringer Ingelheim and Bristol-Myers Squibb. JF: Consultant/Advisory Board for Janssen Scientific. BAS: Research support from Boston Scientific and Janssen. Consult for Janssen. Speakers’ bureau income Biosense Webster. EDP: Research Grant from Janssen Pharmaceuticals and Eli Lilly. Consultant for Janssen Pharmaceuticals and Boehringer Ingelheim. JPP: Research grant from Agency for Healthcare Research and Quality, ARCA biopharma, Boston Scientific, Gilead Sciences, Janssen Pharmaceuticals, Johnson & Johnson, ResMed, Spectranetics and St Jude Medical. Consultant/Advisory Board for BMS/Pfizer, GlaxoSmithKline, Janssen Pharmaceuticals, Johnson & Johnson, Medtronic and Spectranetics., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Treatment patterns and outcomes of individuals with vascular disease who have new-onset atrial fibrillation (AF) are not well characterized., Methods: Among patients with new-onset AF, we analyzed treatment and outcomes in those with or without vascular disease in the ORBIT-AF II registry. Vascular disease was defined as coronary disease with or without myocardial infarction (MI) or revascularization, or peripheral artery disease. The primary outcomes included major adverse cardiovascular or neurological events (MACNE) and major bleeding. Cox proportional hazard models were used to adjust the difference in patient characteristics., Results: Overall 1920 of 6203 (31.0%) of new-onset AF had vascular disease. In patients with vascular disease, 62.2% of those were treated with direct oral anticoagulants (DOACs) and 23.4% with warfarin. Dual therapy and triple therapy were used in 36.9% and 4.9%, respectively. Vascular disease patients had increased risk of MACNE (adjusted hazard ratio [aHR] 1.83 [95%CIs 1.32-2.55]), but not major bleeding (aHR 1.24 [0.95-1.63]). Among patients with vascular disease, relative to those on warfarin, those treated with DOACs had similar risk for MACNE (aHR 1.20 [0.77-1.87]) but lower risks for bleeding, although it did not reach statistical significance (aHR 0.70 [0.43-1.15]). Concomitant antiplatelet therapy was associated with higher bleeding (aHR 2.27 [1.38-3.73]) with no apparent reduction in MACNE (aHR 1.50 [1.00-2.25])., Conclusions: Most patients with AF and vascular disease were managed with oral anticoagulation. About half of them were also treated with concomitant antiplatelet therapy, which was associated with increased risk of bleeding, without evidence of improved cardiovascular outcomes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: The association with B-type natriuretic peptide (BNP), disease progression and outcomes in patients with atrial fibrillation (AF) has not been thoroughly investigated., Methods: We evaluated the association between BNP levels and outcomes, including AF progression, composite outcome of major adverse cardiovascular or neurological events (MACNE) and major bleeding, via pooled logistic regression and Cox frailty models in Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry. AF progression was defined as either paroxysmal becoming persistent or permanent, or persistent becoming permanent at any follow-up., Results: Among 13 375 patients with AF, 2797 with BNP values at baseline (median age (IQR), 72.0 (63.0-80.0) years; 43.0% women; median BNP, 238 (102-502) ng/L; 42.3% prior heart failure) were included in the models evaluating the association between BNP levels and MACNE or major bleeding. Of these, 1282 patients with paroxysmal or persistent AF at baseline were analysed in AF progression model. The likelihood of AF progression (adjusted OR, 1.11 for every 100 ng/mL; 95% CI 1.03 to 1.19) and MACNE (adjusted HR, 1.11 for every doubling in BNP values; 95% CI 1.01 to 1.22) increased with BNP concentration, while the elevated BNP values were not associated with increased risks of major bleeding. BNP values improved the risk prediction of AF progression and MACNE when added to conventional risk estimates., Conclusions: BNP levels are associated with increased risk of AF progression and cardiovascular outcomes in patients with AF. Further studies are required to assess whether biomarker-based risk stratification improves patient outcomes., Clinical Trial Registration: NCT01701817., Competing Interests: Competing interests: TI: research grant from JSPS Overseas Research Fellowship and Boston Scientific. LAA: contract with Janssen and Novartis. GCF: consultant/advisory board support from Janssen Pharmaceutical. BJG: member of a Data Safety Monitoring Board for Mount Sinai St Lukes, Boston Scientific, Teva Pharmaceutical Industries, St Jude Medical, Janssen Research & Development, Baxter Healthcare and Cardiovascular Research Foundation; consultant/advisory board for Janssen Scientific Affairs, Cipla, Armetheon and Medtronic. MDE: consultant/advisory board for Boehringer Ingelheim, Diachi Sanko, Pfizer, Bristol-Myers Squibb and Janssen Scientific Affairs. PRK: consultant for Johnson & Johnson. JAR: research grant from Janssen Pharmaceuticals; research support from Boehringer Ingelheim Pharmaceuticals and GlaxoSmithKline; consultancies with Sanofi, Gilead Sciences, CV Therapeutics, GlaxoSmithKline, Merck & Co, Cardiome Pharma, Boehringer Ingelheim Pharmaceuticals and Medtronic; speakers’ bureau income from Sanofi and Boehringer Ingelheim Pharmaceuticals. GVN: research grant from Janssen; consultant/advisory board for Janssen and Daiichi Sankyo. PSC: employee of Janssen; consultant for Optum Rx and Johnson & Johnson. KWM: financial disclosures can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey. DES: consultant/advisory board for Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Johnson & Johnson, Pfizer and Medtronic; research grants from Boehringer Ingelheim and Bristol-Myers Squibb. JVF: consultant/advisory board for Janssen Scientific. BAS: research support from Boston Scientific and Janssen; consult for Janssen; speakers’ bureau income from Biosense Webster. EDP: research grant from Janssen Pharmaceuticals and Eli Lilly; consultant for Janssen Pharmaceuticals and Boehringer Ingelheim. JPP: research grant from Agency for Healthcare Research and Quality, ARCA Biopharma, Boston Scientific, Gilead Sciences, Janssen Pharmaceuticals, Johnson & Johnson, ResMed, Spectranetics and St Jude Medical; consultant/advisory board for BMS/Pfizer, GlaxoSmithKline, Janssen Pharmaceuticals, Johnson & Johnson, Medtronic and Spectranetics. SK, KP, and RGB have no relationship(s) to disclose., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Black and Hispanic patients are less likely than white patients to use oral anticoagulants for atrial fibrillation. Little is known about racial/ethnic differences in use of direct-acting oral anticoagulants (DOACs) for atrial fibrillation., Objective: To assess racial/ethnic differences in the use of oral anticoagulants, particularly DOACs, in patients with atrial fibrillation., Design, Setting, and Participants: This cohort study used data from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II, a prospective, US-based registry of outpatients with nontransient atrial fibrillation 21 years and older who were followed up from February 2013 to July 2016. Data were analyzed from February 2017 to February 2018., Exposures: Self-reported race/ethnicity as white, black, or Hispanic., Main Outcomes and Measures: The primary outcome was use of any oral anticoagulant, particularly DOACs. Secondary outcomes included the quality of anticoagulation received and oral anticoagulant discontinuation at 1 year., Results: Of 12 417 patients, 11 100 were white individuals (88.6%), 646 were black individuals (5.2%), and 671 were Hispanic individuals (5.4%) with atrial fibrillation. After adjusting for clinical features, black individuals were less likely to receive any oral anticoagulant than white individuals (adjusted odds ratio [aOR], 0.75 [95% CI, 0.56, 0.99]) and less likely to receive DOACs if an anticoagulant was prescribed (aOR, 0.63 [95% CI, 0.49-0.83]). After further controlling for socioeconomic factors, oral anticoagulant use was no longer significantly different in black individuals (aOR, 0.78 [95% CI, 0.59-1.04]); among patients using oral anticoagulants, DOAC use remained significantly lower in black individuals (aOR, 0.73 [95% CI, 0.55-0.95]). There was no significant difference between white and Hispanic groups in use of oral anticoagulants. Among patients receiving warfarin, the median time in therapeutic range was lower in black individuals (57.1% [IQR, 39.9%-72.5%]) and Hispanic individuals (51.7% [interquartile range {IQR}, 39.1%-66.7%]) than white individuals (67.1% [IQR, 51.8%-80.6%]; P < .001). Black and Hispanic individuals treated with DOACs were more likely to receive inappropriate dosing than white individuals (black patients, 61 of 394 [15.5%]; Hispanic patients, 74 of 409 [18.1%]; white patients, 1003 of 7988 [12.6%]; P = .01). One-year persistence on oral anticoagulants was the same across groups., Conclusions and Relevance: After controlling for clinical and socioeconomic factors, black individuals were less likely than white individuals to receive DOACs for atrial fibrillation, with no difference between white and Hispanic groups. When atrial fibrillation was treated, the quality of anticoagulant use was lower in black and Hispanic individuals. Identifying modifiable causes of these disparities could improve the quality of care in atrial fibrillation.

Asymptomatic atrial fibrillation (AF) is being increasingly diagnosed via implantable devices, screening, and inpatient telemetry. Management of asymptomatic AF is controversial, in part, because the associated risks have not been well described. We examined the incidence of major adverse outcomes in patients with asymptomatic versus symptomatic AF using Outcomes Registry for Better Informed Treatment of Atrial, a nationwide US registry of AF patients. We compared stroke and/or non-central nervous system (CNS) embolism, major adverse cardiovascular and neurologic events, bleeding, and death in 9,319 asymptomatic (defined by European Heart Rhythm Association score = 1 or "no symptoms") versus symptomatic patients. Overall, median (interquartile) age was 75 (67 to 82) years, 3,944 (42%) were women, and 38% versus 37% were asymptomatic based on physician versus patient-reported symptoms. Compared with those with symptoms, physician-defined asymptomatic patients were less likely to be woman (35%/47%) or be on an antiarrhythmic agent (22%/33%), but were more likely to have permanent and/or persistent AF (51%/40%). CHA 2 DS 2 -VASc scores did not vary by symptom status. After adjustment, risk of first stroke and/or non-CNS embolism (hazard ratio [HR] 0.85 [95% confidence interval {CI} 0.63 to 1.16], p = 0.32), major adverse cardiovascular and neurologic events (HR 0.88 [95% CI 0.76 to 1.03], p = 0.11), bleeding (HR 0.85 [95% CI 0.72 to 1.00], p = 0.05), and death (HR 0.99 [95% CI 0.87 to 1.13], p = 0.88) were similar in asymptomatic (European Heart Rhythm Association = 1) and symptomatic AF, respectively. Prospective, randomized studies are needed to further define associated adverse events and delineate optimal prophylactic therapies in patients with asymptomatic AF., (Copyright © 2018. Published by Elsevier Inc.)

Objective: Chronic obstructive pulmonary disease (COPD) is associated with the development of atrial fibrillation (AF), and may complicate treatment of AF. We examined the association between COPD and symptoms, quality of life (QoL), treatment and outcomes among patients with AF., Methods: We compared patients with and without a diagnosis of COPD in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation, a prospective registry that enrolled outpatients with AF not secondary to reversible causes, from both academic and community settings., Results: Among 9749 patients with AF, 1605 (16%) had COPD. Relative to patients without COPD, those with COPD were more likely to be older, current/former smokers (73% vs 43%), have heart failure (54% vs 29%) and coronary artery disease (49% vs 34%). Oral anticoagulant and beta blocker use were similar, whereas digoxin use was more common among patients with COPD. Symptom burden was generally higher, and QoL worse, among patients with COPD (median Atrial Fibrillation Effect on QualiTy-of-Life score 76 vs 83). Patients with COPD had higher risk of all-cause mortality (adjusted HR 1.52 (95% CI 1.32 to 1.74)), cardiovascular mortality (adjusted HR 1.51 (95% CI 1.24 to 1.84)) and cardiovascular hospitalisation (adjusted HR 1.15 (95% CI 1.05 to 1.26)). Patients with COPD also had higher risk of major bleeding events (adjusted HR 1.25 (95% CI 1.05 to 1.50)). There did not appear to be associations between COPD and AF progression, ischaemic events or new-onset heart failure., Conclusions: Among patients with AF, COPD is associated with higher symptom burden, worse QoL, and worse cardiovascular and bleeding outcomes. These associations were not fully explained by cardiovascular risk factors, AF treatment or smoking history., Clinical Registration Number: NCT01165710., Competing Interests: Competing interests: LAA reports personal fees from Novartis and from Janssen during the conduct of the study, grants from PCORI, grants from American Heart Association, grants from NIH and personal fees from Boston Scientific, outside the submitted work. PSC reports consulting fees from Optum Rx and from American Heart Association, and grants from NIH. JVF reports personal fees from American College of Cardiology and from the National Cardiovascular Data Registry, personal fees from Janssen Pharmaceuticals, and grants from NHLBI, outside the submitted work. GCF reports personal fees from Janssen and personal fees from Medtronic, outside the submitted work. ASG reports that he has received a research grant through his institution from iRhythm Technologies. EMH reports personal fees from Advisory Boards: Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Janssen, Medtronic, Pfizer and Portola; personal fees from honoraria for symposia: Bristol Myers Squibb, Boehringer Ingelheim, DOASENSE and Pfizer, outside the submitted work. KWM reports grants from Afferent, grants from Amgen, grants and personal fees from AstraZeneca, from Daiichi, grants from Ferring, grants from Google (Verily), grants and personal fees from Johnson & Johnson, grants from Medtronic, grants and personal fees from Merck, grants and personal fees from Novartis, grants from Sanofi, grants from St. Jude, personal fees from Ablynx, personal fees from BAROnova, from Bio2Medical, personal fees from Boehringer Ingelheim, personal fees from Bristol Myers Squibb, personal fees from Cardiometabolic Health Congress, personal fees from Cubist, personal fees from Eli Lilly, personal fees from Elsevier, personal fees from Epson, personal fees from Glaxo Smith Kline, personal fees from Mt. Sinai, personal fees from Myokardia, personal fees from Oculeve, personal fees from Portola, personal fees from Radiomeer, personal fees from Springer Publishing, personal fees from The Medicines Company, personal fees from Theravance, personal fees from UCSF, personal fees from Vindico, personal fees from WebMD, outside the submitted work. SDP reports grants from Janssen Pharmaceuticals, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from Pfizer, grants from Food and Drug Administration, during the conduct of the study; grants and personal fees from Boston Scientific, personal fees from Medtronic, grants from Gilead, outside the submitted work. JAR reports grants from Janssen, during the conduct of the study; grants from Medtronic, personal fees from Portola, personal fees from Boehringer Ingelheim, outside the submitted work. DES reports personal fees from Johnson & Johnson, during the conduct of the study; grants from Bristol-Myers Squibb, grants from Boehringer Ingelheim, personal fees from Bristol-Myers Squibb, personal fees from Boehringer Ingelheim, personal fees from CVS Health, personal fees from Johnson & Johnson, personal fees from Merck, personal fees from Pfizer, personal fees from Medtronic, outside the submitted work. EDP reports grants and personal fees from Janssen Pharmaceuticals, outside the submitted work. JPP reports grants to his institution from ARCA Biopharma, Boston Scientific, Gilead Sciences, Janssen Pharmaceuticals, St. Jude Medical, and ResMed; consultancy fees from Amgen, Spectranetics, Medtronic, Allergan, Janssen Pharmaceuticals., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Mineralocorticoid receptor antagonist (MRA) therapy may be beneficial to patients with atrial fibrillation (AF), but little is known about their use in patients with AF and subsequent outcomes., Methods and Results: In order to better understand MRA use and subsequent outcomes, we performed a retrospective cohort study of the contemporary ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registry. AF progression and cardiovascular outcomes were compared using propensity-matched Cox proportional hazards modeling according to MRA use at baseline and new MRA use at follow-up versus patients with no MRA use. Among 7012 patients with nonpermanent AF, 320 patients were taking MRA at enrollment, and 416 patients initiated MRA use during follow-up. The mean patient age was 72.5 years, 56.3% were men, and 70.4% had paroxysmal AF. Among all patients taking MRAs, 434 (59.0%) had heart failure, 655 (89.0%) had hypertension, and 380 (51.6%) had both. After adjustment, new MRA use was not associated with reduced AF progression (hazard ratio, 1.18; 95% confidence interval, 0.88-1.58; P =0.27) but showed a trend towards lower risk of stroke, transient ischemic attack, or systemic embolism (hazard ratio, 0.17; 95% confidence interval, 0.02-1.23; P =0.08). Results were similar for a comparison of new MRA users and baseline MRA users compared with nonusers., Conclusions: In community-based outpatients with AF, the majority of MRA use was for heart failure and hypertension. MRA use also trended towards lower adjusted stroke risk. Future studies should test the hypothesis that MRA use may decrease the risk of stroke in patients with AF., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Objective: To examine reader performance in evaluating oropharyngeal anatomy on ultrasonography., Materials and Methods: Ultrasound images of the oropharynx comprising normal and malignant anatomic variants were organized into slideshows. Slideshows were administered to 6 readers blinded to participant tumor status and with varying experience reading oropharyngeal sonograms. A training slideshow oriented readers to images of the oropharynx with and without malignant lesions. Readers then evaluated images in a test slideshow for tumor presence and marked orthogonal long and short dimensions of the tumor. Results were analyzed for accuracy, sensitivity, specificity, inter-reader agreement, and measurement error relative to prospectively-identified reference measurements., Results: Eighty-seven percent of base of tongue (BOT) sonograms were identified correctly by a majority of readers. In identifying BOT tumors, median accuracy, sensitivity, specificity, and Fleiss's kappa were 79%, 73%, 85%, and 0.51, respectively. Median measurement error in the long and short axes for BOT tumors was -2.6% (range: -40% to 29%) and -2.6% (range: -56% to 156%), respectively. Eighty-four percent of palatine tonsil sonograms were identified correctly by a majority of readers. In identifying tonsil tumors, median accuracy, sensitivity, specificity, and Fleiss's kappa were 77%, 74%, 78%, and 0.41, respectively. Median measurement error in the long and short axes for tonsil tumors was 3.8% (range: -45% to 32%) and -6.5% (range: -83% to 42%), respectively., Conclusions: Overall, US has clinically useful sensitivity for identification of oropharyngeal carcinoma among readers of diverse clinical backgrounds and experience. US may be useful for the evaluation of features such as tumor dimensions., (Copyright © 2017. Published by Elsevier Ltd.)

Importance: Atrial fibrillation (AF) is usually classified on the basis of the disease subtype. However, this characterization does not capture the full heterogeneity of AF, and a data-driven cluster analysis reveals different possible classifications of patients., Objective: To characterize patients with AF based on a cluster analysis and to evaluate the association between these phenotypes, treatment, and clinical outcomes., Design, Setting, and Participants: This cluster analysis used data from an observational cohort that included 9749 patients with AF who had been admitted to 174 US sites participating in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Data analysis was completed from January 2017 to October 2017., Exposure: Patients with diagnosed AF who were included in the registry., Main Outcomes and Measures: Composite of major adverse cardiovascular or neurological events and major bleeding, as defined by the International Society of Thrombosis and Hemostasis criteria., Results: Of 9749 total patients, 4150 (42.6%) were female; 8719 (89.4%) were white and 477 (4.9%) were African American. A cluster analysis was performed using 60 baseline clinical characteristics, and it classified patients with AF into 4 statistically driven clusters: (1) those with considerably lower rates of risk factors and comorbidities than all other clusters (n = 4673); (2) those with AF at younger ages and/or with comorbid behavioral disorders (n = 963); (3) those with AF who had similarities to patients with tachycardia-brachycardia and had device implantation owing to sinus node dysfunction (n = 1651); and (4) those with AF and prior coronary artery disease, myocardial infarction, and/or atherosclerotic comorbidities (n = 2462). Conventional classifications, such as AF subtype and left atrial size, did not drive cluster formation. Compared with the low comorbidity AF cluster, adjusted risks of major adverse cardiovascular or neurological events were significantly higher in the other 3 clusters (behavioral comorbidity cluster: hazard ratio [HR], 1.49; 95% CI, 1.10-2.00; device implantation cluster: HR, 1.39; 95% CI, 1.15-1.68; and atherosclerotic comorbidity cluster: HR, 1.59; 95% CI, 1.31-1.92). For major bleeding, adjusted risks were higher in the behavioral disorder comorbidity cluster (HR, 1.35; 95% CI, 1.05-1.73), those with device implantation (HR, 1.24; 95% CI, 1.05-1.47), and those with atherosclerotic comorbidities (HR, 1.13; 95% CI, 0.96-1.33) compared with the low comorbidity cluster. The same clusters were identified in an external validation in the ORBIT AF II registry., Conclusions and Relevance: Cluster analysis identified 4 clinically relevant phenotypes of AF that each have distinct associations with clinical outcomes, underscoring the heterogeneity of AF and importance of comorbidities and substrates.

Background: Time in therapeutic range (TTR) of international normalized ratio (INR) of 2.0 to 3.0 is important for the safety and effectiveness of warfarin anticoagulation. There are few data on TTR among patients with atrial fibrillation (AF) in community-based clinical practice., Methods: Using the US Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), we examined TTR (using a modified Rosendaal method) among 5,210 patients with AF on warfarin and treated at 155 sites. Patients were grouped into quartiles based on TTR data. Multivariable logistic regression modeling with generalized estimating equations was used to determine patient and provider factors associated with the lowest (worst) TTR., Results: Overall, 59% of the measured INR values were between 2.0 and 3.0, with an overall mean and median TTR of 65% ± 20% and 68% (interquartile range [IQR] 53%-79%). The median times below and above the therapeutic range were 17% (IQR 8%-29%) and 10% (IQR 3%-19%), respectively. Patients with renal dysfunction, advanced heart failure, frailty, prior valve surgery, and higher risk for bleeding (ATRIA score) or stroke (CHA2DS2-VASc score) had significantly lower TTR (P < .0001 for all). Patients treated at anticoagulation clinics had only slightly higher median TTR (69%) than those not (66%) (P < .0001)., Conclusions: Among patients with AF in US clinical practices, TTR on warfarin is suboptimal, and those at highest predicted risks for stroke and bleeding were least likely to be in therapeutic range., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Human papillomavirus (HPV) tumor status and surgical salvage are associated with improved prognosis for patients with recurrent oropharyngeal squamous cell carcinoma (OPSCC). Current data regarding types of surgery and the impact of surgery for patients with distant metastatic disease are limited., Methods: A retrospective analysis of patients with recurrent OPSCC from 2 institutions between 2000 and 2012 was performed. p16 immunohistochemistry and/or in situ hybridization, as clinically available, were used to determine HPV tumor status. Clinical characteristics, distribution of recurrence site, and treatment modalities were compared by HPV tumor status. Overall survival (OS) was examined using Kaplan-Meier and Cox proportional hazards methods., Results: The current study included 108 patients with 65 locoregional and 43 distant metastatic first recurrences. The majority of patients were HPV-positive (80 patients). HPV-positive tumor status was associated with longer time to disease recurrence (P<.01). Anatomic site distribution of disease recurrences did not differ by HPV tumor status. HPV-positive tumor status (adjusted HR [aHR], 0.23; 95% confidence interval [95% CI], 0.09-0.58 [P = .002]), longer time to disease recurrence (≥ 1 year; aHR, 0.36; 95% CI, 0.18-0.74 [P = .006]), and surgical salvage (aHR, 0.26; 95% CI, 0.12-0.61 [P = .002]) were found to be independently associated with OS after disease recurrence. Surgical salvage was independently associated with improved OS compared with nonsurgical treatment among patients with both locoregional (aHR, 0.15; 95% CI, 0.04-0.56 [P = .005]) and distant (aHR, 0.19; 95% CI, 0.05-0.75 [P = .018]) metastatic disease recurrences., Conclusions: Surgical salvage was found to be associated with improved OS for patients with recurrent locoregional and distant metastatic OPSCC, independent of HPV tumor status. Further prospective data are needed to confirm the role of surgical salvage for distant metastases., (© 2015 American Cancer Society.)

Purpose: The purpose of this study was to determine the incidence of and risk factors for pharyngocutaneous fistula in patients undergoing total laryngectomy at a single institution., Materials and Methods: The records of 59 patients undergoing primary or salvage total laryngectomy at our institution from 2001 to 2012 were retrospectively reviewed. Data collected included patient, tumor and treatment characteristics, and surgical technique. Risk factors were analyzed for association with pharyngocutaneous fistula formation., Results: Twenty patients (34%) developed fistulas. Preoperative tracheostomy (OR 4.1; 95% CI 1.3-13 [p=0.02]) and low postoperative hemoglobin (OR 9.1; 95% CI 1.1-78 [p=0.04]) were associated with fistula development. Regarding surgical technique, primary sutured closure of the total laryngectomy defect had the lowest fistula rate (11%). In comparison, primary stapled closure and pectoralis onlay flap over primary closure had nonsignificantly increased fistula rates (43%, OR 6.0; 95% CI 1.0-37.3 [p=0.06] and 25%, OR 2.7; 95% CI 0.4-23.9 [p=0.38], respectively). Pectoralis flap incorporated into the suture line had a significantly increased fistula rate (50%, OR 7.1; 95% CI 1.4-46 [p=0.02]). After stratification for salvage status, patient comorbidities were associated with fistula in non-salvage cases whereas disease-related characteristics were associated with fistula in salvage cases. Fistula development was associated with increased length of hospital stay (p<0.001) and increased time before oral diet initiation (p<0.001)., Conclusions: Pharyngocutaneous fistula is a common complication of total laryngectomy. Preoperative tracheostomy, postoperative hemoglobin, and surgical technique are important in determining the risk of fistula., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Recent clinical trials have demonstrated the safety and efficacy of several non-vitamin K oral anticoagulants (NOACs) for the treatment of atrial fibrillation (AF). However, there are limited data on their use and outcomes in routine clinical practice, particularly among patients newly diagnosed as having AF and patients with AF recently transitioned to a NOAC., Methods/design: ORBIT-AF II is a multicenter, national registry of patients with AF that is enrolling up to 15,000 newly diagnosed patients with AF and/or those with AF recently transitioned to a NOAC from 300 US outpatient practices. These patients will be followed for up to 2 years, including clinical status, outcomes (major adverse cardiovascular events, bleeding), and management of anticoagulation surrounding bleeding events. In addition, detailed data regarding the use of these agents in and around cardiac procedures, their complications, and management of such complications will be collected., Conclusions: The ORBIT-AF II registry will provide valuable insights into the safety and effectiveness of NOACs used in AF in community practice settings., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: Base of tongue (BOT) is a difficult subsite to examine clinically and radiographically. Yet, anatomic delineation of the primary tumor site, its extension to adjacent sites or across midline, and endophytic vs. exophytic extent are important characteristics for staging and treatment planning. We hypothesized that ultrasound could be used to visualize and describe BOT tumors., Methods: Transcervical ultrasound was performed using a standardized protocol in cases and controls. Cases had suspected or confirmed BOT malignancy. Controls were healthy individuals without known malignancy., Results: 100% of BOT tumors were visualized. On ultrasound BOT tumors were hypoechoic (90.9%) with irregular margins (95.5%). Ultrasound could be used to characterize adjacent site involvement, midline extent, and endophytic extent, and visualize the lingual artery. No tumors were suspected for controls., Conclusions: Ultrasonography can be used to transcervically visualize BOT tumors and provides clinically relevant characteristics that may not otherwise be appreciable.

Objective: To report a single institution's experience with transoral robotic surgery (TORS) and its clinical outcomes. This was a retrospective study carried out at a university-affiliated teaching hospital., Subjects and Methods: Forty-four consecutive TORS patients with benign and malignant diseases were reviewed. Data on demographics, clinical parameters, and diet were collected. Surgical margins, local and regional recurrence, distant metastasis, 2-year disease-free survival rate, and 2-year survival data were reviewed for the malignant cases., Results: Nine benign and 35 proven squamous cell carcinoma (SCCA) cases underwent TORS. The set-up time was 17.12 minutes (range, 10-40 minutes), and operative time was 53 minutes (range, 10-300 minutes). Average length of stay was 2.5 days. There were seven (6.8%) grade 3 surgical complications. Surgical infection rate was 2.3%. Benign cases were on a regular diet after TORS. Of the malignant cases, 94% were taking peroral diet immediately after the TORS procedure. There were no intraoperative complications and no 30-day postoperative mortalities. The mean follow-up time was 25.2 months (range, 16-38 months) for malignant disease. The SCCA sites were in the oropharynx (30/35), larynx (2/35), and unknown primary with neck metastasis (3/35). Unknown primary patients were excluded in the surgical margin analyses. Negative margins were achieved in 91% of cases. The local and regional recurrence rates were 6.3% (2/32) and 3.1% (1/32), respectively. Two patients (6.3%) developed distant metastasis. Oropharyngeal SCCA cases were reviewed, of which 23 were human papillomavirus (HPV)/p16 positive and 7 were HPV/p16 negative. The 2-year actual survival for HPV-positive and -negative patients was 96% (22/23) and 86% (6/7), respectively. The 2-year disease-free survival for HPV-positive and -negative cases was 91% (21/23) and 71.4% (5/7), respectively. All malignant cases that underwent TORS received postoperative adjuvant therapy., Conclusions: TORS is a safe procedure with minimal complications and acceptable clinical and functional outcomes.

Objective and Study Design: To assess the feasibility of robotic-assisted skull base surgery, a preclincal cadaver study was conducted., Materials and Methods: The feasibility study was subdivided into three phases: Phase 1 (surgical corridor) entailed a review of the surgical access, Phase 2 (instrument configuration) entailed arrangements of the robotic instrument (da Vinci(®) Surgical System; Intuitive Surgical, Sunnyvale, CA) in relation to the surgical corridor and applied to a skull model, and Phase 3 was robotic-assisted skull base cadaver dissection., Results: Regarding the surgical corridor, the infratemporal area was accessed through a maxillary window, whereas the anterior skull base region was accessed through a combined single maxillary window and nasal corridor. Regarding instrument configuration, the camera was positioned above the two instrument arms, with both instrument arms angled at 30° to the camera axis with a flexed distal tip for the infratemporal skull base. For the anterior skull base, one of the robotic arms was inserted through the unilateral maxillary window, whereas the three-dimensional camera and the second arm were inserted through the nasal corridor. Regarding the robotic-assisted skull base cadaver dissection, we define the robotic set-up time in this study as the time required to move the robot into position, obtain adequate operative exposure, and place the robotic arms prior to the start of robotic dissection. The robotic set-up time for the anterior skull base dissection averaged 95 minutes, and that for pituitary resection was 61 minutes. The robotic set-up time for infratemporal dissection averaged 23 minutes. Operative time was 63.5 minutes. Robotic and endoscopic techniques can be combined during surgery., Conclusions: Robotic-assisted skull base surgery is feasible. The da Vinci instrument needs to be redesigned to be smaller and preferably with distal articulating tips, prior to clinical application of robotics to skull base surgery.

Objectives/hypothesis: To determine the feasibility and safety of neck dissection through a facelift incision., Study Design: Prospective case series., Methods: Cadavers and live subjects underwent neck dissection using a facelift incision with and without endoscopic assistance. In the live facelift neck dissection (FLND), the preoperative surgical indications, staging, adjuvant therapy, intraoperative technical procedure, pathology reports on lymph nodes, and short-term outcomes were reviewed., Results: FLND was successfully performed in four cadavers and four live subjects, including selective (less than five neck levels removed) and comprehensive (levels I-V removed) neck dissections. All levels were accessible through this approach, with additional retraction required for levels I and IV. Endoscopic assistance was required in one neck dissection for adequate visualization. Short-term complications and number of excised lymph nodes were comparable to those from traditional neck dissection approaches., Conclusions: Open neck dissection through a facelift incision is feasible and offers an alternate approach to traditional incisions. This can be performed without requiring robotic assistance and with endoscopic assistance only in certain cases. Endoscopic assistance can offer enhanced visualization of the surgical field and complement open direct approaches in neck dissection. Although FLND offers improved cosmetic outcomes when compared to those of traditional neck incisions, further study is required to determine its efficacy and indications., (Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.)

The introduction of robotics in head and neck surgery has facilitated access to the contents of the neck region using less cosmetically obtrusive incisions. Robotic systems offer a three-dimensional viewing, tremor filtration, and articulating distal arms that mimic natural hand and wrist movements. We hypothesized that these characteristics would allow for the performance of a robotic-assisted selective and comprehensive neck dissection via combined pre- and post-auricular incisions. We were able to demonstrate adequate access in a cadaver, using a combination of conventional, endoscopic, and robotic surgical manipulation. Thus preclinical cadaver studies support the ability to perform robotic-assisted neck dissection via combined pre- and post-auricular incisions.

Purpose: The optimal dosage and frequency of platinum-based chemoradiotherapy (CRT) regimen for treating advanced head and neck squamous cell carcinoma remains unresolved. This study aims to compare the toxicity and efficacy of weekly versus more dose-intensive cisplatin-based CRTs., Methods: We reviewed 155 stage III/IV head and neck squamous cell carcinoma patients with no evidence of distant metastasis treated with one of two CRT regimens from 2000 to 2010 at Greater Baltimore Medical Center. Twice-daily radiation was provided as a split course over a 45-day period. Regimen A consisted of concomitant cisplatin (30 mg/m2/1 h) weekly for 6 cycles; regimen B consisted of concomitant cisplatin (12 mg/m2/1 h) and 5-fluorouracil (600 mg/m2/20 h) on days 1 through 5 and days 29 through 33. Main outcome measures included acute toxicities (myelosuppression, neurotoxicity, nephrotoxicity, gastrointestinal dysfunction), unplanned hospitalizations, and disease control at 12 months., Results: Patients on regimen A were much less likely to experience ototoxicity due to their treatment (0% vs. 9.8%, P = 0.04). They were more likely to experience thrombocytopenia acutely (46% vs. 26%, P = 0.02), but the toxicity was not limiting (grade 1–2). No significant differences exist in the incidence of other toxicities or unplanned hospitalizations. At 1 year, 97% of patients on A vs. 86% of patients on regimen B were free of disease (P = 0.11)., Conclusions: With concurrent radiotherapy, low-dose, single-agent, weekly cisplatin is less likely than higher-dose daily cisplatin plus 5-fluorouracil provided at the beginning and end of treatment to be associated with ototoxicity. The preliminary data suggest at least equivalent efficacy, but longer follow-up is required.

Background. The purpose of this study was to assess the effects of amifostine on submandibular gland histology in patients receiving chemoradiation therapy. Methods. We conducted a retrospective submandibular gland histologic slide review of HNSCC patients receiving chemoradiation for head and neck squamous cell carcinoma with three different levels of amifostine exposure. We used six scoring parameters: fatty replacement, lobular architecture degeneration, interstitial fibrosis, ductal degeneration, acinar degeneration, and inflammatory component presence. Results. Differences in gender, tumor stage, amifostine dose, age, number of days after neck dissection, and smoking history (pack years) exposure were not significant between the three groups, although there was a difference between groups in the primary subsite (P = 0.006). The nonparametric Cuzick's test for histologic parameters with varied amifostine treatment showed no significance among the three groups. Conclusions. Although patients did not receive a full dose of amifostine due to side effects, varying doses of amifostine had no apparent evident cytoprotective effects in three groups of cancer patients treated with primary chemoradiation.

Objective. We reviewed a cohort of patients with previously untreated locoregional advanced head and neck squamous cell carcinoma (HNSCC) who received a uniform chemoradiotherapy regimen. Methods. Retrospective review was performed of 105 patients with stage III or IV HNSCC treated at Greater Baltimore Medical Center from 2000 to 2007. Radiation included 125 cGy twice daily for a total 70 Gy to the primary site. Chemotherapy consisted of cisplatin (12 mg/m(2)/h) daily for five days and 5-fluorouracil (600 mg/m(2)/20 h) daily for five days, given with weeks one and six of radiation. All but seven patients with N2 or greater disease received planned neck dissection after chemoradiotherapy. Primary outcomes were overall survival (OS), locoregional control (LRC), and disease-free survival (DFS). Results. Median followup of surviving patients was 57.6 months. Five-year OS was 60%, LRC was 68%, and DFS was 56%. Predictors of increased mortality included age ≥55, female gender, hypopharyngeal primary, and T3/T4 stage. Twelve patients developed locoregional recurrences, and 16 patients developed distant metastases. Eighteen second primary malignancies were diagnosed in 17 patients. Conclusions. The CRT regimen resulted in favorable outcomes. However, locoregional and distant recurrences cause significant mortality and highlight the need for more effective therapies to prevent and manage these events.

Purpose. To analyze the patterns and associations of adjunctive service visits by head and neck cancer patients receiving primary, concurrent chemoradiation therapy. Methods. Retrospective chart review of patients receiving adjunctive support during a uniform chemoradiation regimen for stages III-IV head and neck squamous cell carcinoma. Univariate and multivariate models for each outcome were obtained from simple and multivariate linear regression analyses. Results. Fifty-two consecutive patients were assessed. Female gender, single marital status, and nonprivate insurance were factors associated with an increased number of social work visits. In a multivariate analysis, female gender and marital status were related to increased social work services. Female gender and stage IV disease were significant for increased nursing visits. In a multivariate analysis for nursing visits, living greater than 20 miles between home and hospital was a negative predictive factor. Conclusion. Treatment of advanced stage head and neck cancer with concurrent chemoradiation warrants a multidisciplinary approach. Female gender, single marital status, and stage IV disease were correlated with increased utilization of social work and nursing services. Distance over 20 miles from the center was a negative factor. This information may help guide the treatment team to allocate resources for the comprehensive care of patients.

Background: The purpose of this study was to elucidate factors associated with pharyngoesophageal strictures after treatment for head and neck squamous cell carcinoma (SCC)., Methods: We conducted a retrospective review of patients receiving cisplatin and 5-fluorouracil chemotherapy combined with concurrent hyperfractionated radiation therapy for oropharyngeal squamous cell carcinoma., Results: Strictures developed in 13 of 67 patients (19%). Strictures were associated with tumor location (tonsil vs base of tongue; p = .03), neck dissection after completion of therapy (p = .03), and the duration of treatment-induced mucositis (weeks with mucositis grade ≥2; National Cancer Institute (NCI) Common Toxicity Criteria; p < .001). Age, sex, race, tumor stage, nodal stage, American Joint Committee on Cancer (AJCC) stage, human papillomavirus (HPV) status, smoking, radiation dose, maximum severity of mucositis, amifostine use, and pretreatment swallow dysfunction were not significantly associated with stricture. In multivariate analysis, only duration of mucositis, after controlling for age, sex, and tumor location, remained highly significant (p < .01)., Conclusion: The duration of treatment-related mucositis is an independent risk factor for stricture formation in patients with oropharyngeal SCC treated with concurrent chemotherapy and radiation therapy., (Copyright © 2011 Wiley Periodicals, Inc.)

The standard endoscopic surgical approach in the management of laryngeal lesions is by the use of a laryngoscope, microscope, and laser. This requires the surgeon to work within the confines of the laryngoscope. At times, it requires repositioning of the laryngoscope and microscope to gain access to a specific area. The surgery also requires line-of-sight observation to complete the operation. The introduction of transoral robotic surgery in head and neck surgery brings the advantages of three-dimensional magnification, increased degrees of freedom with the effector arms, and an articulating distal end that mimics hand movements. To date, transoral robotic surgery of vocal cord surgery requires the use of a tracheostomy in patients. Here we report the use of a CO(2) laser fiber and the Da Vinci robotic platform (Intuitive Surgical) for the surgical management of a T1 glottic squamous cell carcinoma.

Objective: To determine whether a comprehensive neck dissection (CND) or a selective neck dissection (SND) is indicated as planned post-primary chemoradiation treatment (CRT) for patients with advanced oropharyngeal squamous cell carcinoma (OPSCC)., Study Design: Case series with chart review., Setting: A community teaching hospital., Subjects: Patients with advanced OPSCC who received a uniform CRT protocol at Greater Baltimore Medical Center (GBMC)., Methods: Medical records of patients treated with primary CRT for locoregionally advanced OPSCC at GBMC between 2001 and 2007 were reviewed. All patients received 7000 to 7500, 6000, and 5000 cGy to primary disease sites, involved cervical lymphatics, and uninvolved cervical and supraclavicular lymphatics, respectively, with concomitant cisplatin (12 mg/m(2)/1 h) and 5-fluorouracil (600 mg/m(2)/20 h) given on days one through five and 29 through 33., Results: Seventy-six patients received CRT, and 41 met the criteria for neck dissection. Forty-eight neck dissections were performed (34 unilateral and 7 bilateral), of which 23 (48%) were CNDs and 25 (52%) were SNDs. Residual carcinoma was found in six (26%) of the CND and five (20%) of the SND heminecks. The CND group had six (26%) complications, whereas the SND group had two (8%)., Conclusion: The high rate of residual disease demonstrated in this study supports the need for post-CRT neck dissection. Although complication rates were not significantly different between the two groups, the trend in this study indicates that SND results in less morbidity. The presumed reduced morbidity and equivalent regional control rate suggest that SND is an appropriate surgical option for OPSCC patients after primary CRT.

We report a patient in Automatic Peritoneal Dialysis (APD) with tuberculous peritonitis by possible peritoneal infection due to the proximity between fallopian tube and the left ovary, a peritoneal liquid culture was constantly negative. The patient presented a bad clinic evolution. Her only medical history was hypercalcemia six months before developing a peritonitis and occasionally nausea and vomits To confirm the diagnosis it was needed a peritoneal biopsy by means of a laparoscopy with a removal of the peritoneal catheter and left anexectomy. Now, the patient is asintomatic in daily home hemodialysis.

Background: The diagnosis of abdominal wall endometriomas is often confused with other surgical conditions., Methods: A retrospective study was made of 12 patients presenting with an abdominal wall mass, which proved to be endometrioma., Results: Of a total of 297 patients of endometriosis treated in our hospital over a 7-year period, 12 (4%) had isolated abdominal wall endometriomas. Their mean age was 29.4 years. The presenting symptoms were abdominal mass (n = 12), cyclical (n = 5) or noncyclic pain (n = 7), dyspareunia and dysmenorrhea (n = 1). All patients had a history of gynecologic operations and presented, after an average of 1.9 years, with a tender mass (average 4 cm) at the previous incision site. Preoperative diagnosis was correct in 4 patients (33%) who presented with a cyclically painful abdominal mass. The others were diagnosed as incisional hernia (n = 4), "abdominal wall tumor" (n = 2), and inguinal hernia (n = 2). All patients underwent wide excision of their endometrioma; 2 required polytetrafluoroethylene patch grafting for the resulting fascial defect. The diagnosis was confirmed at frozen section or conventional histological examination in all patients. At follow-up, ranging from 4 months to 3 years, there was no recurrence of endometrioma., Conclusions: Scar endometrioma commonly presents as an abdominal mass with noncyclical symptoms. Imaging techniques are nonspecific and needle biopsy may confirm the diagnosis. Wide excision is the treatment of choice for abdominal wall endometrioma as well as for recurrent lesions.