Comparison of Anticoagulants for Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Pilot Study.

BACKGROUND: Direct-acting oral anticoagulants are indicated for the treatment of nonvalvular atrial fibrillation, but their use in patients after undergoing cardiac surgery is poorly defined despite a high prevalence of postoperative atrial fibrillation in this population. METHODS: Patients diagnosed with postoperative atrial fibrillation were prospectively randomized to warfarin or apixaban. Safety, efficacy, and economic outcomes were evaluated until their 4- to 6-week postoperative appointment. RESULTS: While this pilot study was not powered to determine a difference in safety or efficacy, adverse event rates were similar to the published literature. It was noted that a patient's course of therapy when utilizing apixaban was significantly less costly than warfarin when including medication, bridging, and laboratory expenses. CONCLUSION: Apixaban and warfarin both appeared to be safe and effective for anticoagulation throughout the duration of this pilot study in treating postoperative atrial fibrillation after coronary artery bypass grafting. Apixaban was associated with significantly less expense when bridging and monitoring costs were included in addition to medication expense.

The Oldest Old: A National Analysis of Outcomes for Patients 90 Years or Older With Lung Cancer.

BACKGROUND: Most clinicians will encounter patients 90 years or older with non-small cell lung cancer (NSCLC), but evidence that informs treatment decisions for this extremely elderly population is lacking. This study evaluated outcomes associated with treatment strategies for this nonagenarian population. METHODS: Treatment and overall survival for patients 90 years and older with NSCLC in the National Cancer Data Base (2004-2014) were evaluated using logistic regression, the Kaplan-Meier method, and multivariable Cox proportional hazard models. RESULTS: The majority (n = 4152, 57.6%) of the 7205 patients 90 years or older with stage I-IV NSCLC did not receive any therapy. For the entire cohort, receiving treatment was associated with significantly better survival when compared with no therapy (5-year survival, 9.3% [95% confidence interval [CI], 8.0%-10.7%] vs 1.7% [95% CI, 1.2%-2.2%]; multivariable adjusted hazard ratio, 0.53; P < .001). Stage I patients had the most pronounced survival benefit with treatment (median survival, 27.4 months vs 10.0 months with no treatment; P < .001). Among this subset of patients with stage I disease (n = 1430), only 12.7% (n = 182) had surgery and 33% (n = 471) had no therapy. In these stage I patients surgery was associated with significantly better 5-year survival (33.7% [95% CI, 25.4%-42.1%]) than nonoperative therapy (17.1% [95% CI, 13.7%-20.8%]) and no therapy (6.2% [95% CI, 3.8%-9.4%]). CONCLUSIONS: Therapy for nonagenarians with NSCLC is associated with a significant survival benefit but is not used in most patients. Treatment should not be withheld for these "oldest old" patients based on their age alone but should be considered based on stage and patient preferences in a multidisciplinary setting.

Mission of Mercy patient characteristics and dental-related emergency department use.

BACKGROUND: Although dental Mission of Mercy (MOM) events have existed for more than 2 decades and are held in more than 30 states, systematic data collection and reporting on patient characteristics, oral health care use patterns, and oral health care needs are lacking. METHODS: The authors surveyed patients attending the 2016 Florida MOM, asking about their reasons for seeking oral health care, oral health care use, and dental-related emergency department (ED) use. The authors conducted descriptive and multivariable analyses of survey and patient registration data to describe patient characteristics and examine associations between patient characteristics, time to last dental visit, and ED use. RESULTS: Sixty-six percent of 1,462 study participants reported having orofacial pain; one-third of those were in pain for more than 1 year. Only 18% reported fair or poor overall health, whereas 75% reported fair or poor oral health. Florida MOM attendees who were younger adults, were of non-Hispanic ethnicity, had less than a college education, lived below federal poverty guidelines, and reported poorer oral health were at increased risk of having dental-related ED visits. CONCLUSIONS: Incorporating systematic data collection into dental MOM events provides important information about the characteristics and oral health care needs of clinic attendees that can be used to develop programs to address oral health care access on the basis of community-specific needs. PRACTICAL IMPLICATIONS: Community partners are using study data to develop strategies to address unmet oral health care needs. By systematically collecting information about patients who attend dental MOM events, we can obtain valuable information to create awareness about local community oral health care needs and promote efforts to develop sustainable strategies to improve oral health care access and outcomes.

Validity of arm-leg elliptical ergometer for VO2max analysis.

Maximal oxygen consumption ((Equation is included in full-text article.)) can be determined through multiple exercise modalities intended to elicit an individual's maximal aerobic exertion. Uphill treadmill running is considered the best modality for measuring (Equation is included in full-text article.). Previous studies have examined correlations between treadmill and elliptical ergometer tests as well as the cycle ergometer, but none of the studies use an arm-leg elliptical ergometer (ALE). The purpose of this study was to develop an ALE (Equation is included in full-text article.)testing protocol and determine whether ALE produces valid (Equation is included in full-text article.)values as compared with the treadmill. Twelve undergraduate students (mean age: 20.8 years) completed 2 (Equation is included in full-text article.)tests, 1 on a treadmill and 1 on ALE. (Equation is included in full-text article.)correlation between ALE and treadmill was examined, and paired t-tests were run for (Equation is included in full-text article.)and maximum heart rate (HRmax). A strong positive correlation was found between ALE and treadmill (Equation is included in full-text article.)values (r = 0.84; p < 0.001). There were no differences between (Equation is included in full-text article.)values; however, HRmax values were higher on the treadmill than ALE (p = 0.003). Although future research is needed to examine the observed differences in HRmax between the 2 testing modalities and gender differences in muscle recruitment patterns, the results of this study suggest that ALE is a valid modality for (Equation is included in full-text article.)testing. This will be particularly valuable as a clinical tool to assess (Equation is included in full-text article.)in populations requiring low-impact exercise.

WT1 peptide vaccinations induce CD4 and CD8 T cell immune responses in patients with mesothelioma and non-small cell lung cancer.

BACKGROUND: The transcription factor, WT1, is highly overexpressed in malignant pleural mesothelioma (MPM) and immunohistochemical stains for WT1 are used routinely to aid in its diagnosis. Using computer prediction analysis we designed analog peptides derived from WT1 sequences by substituting amino acids at key HLA-A0201 binding positions. We tested the safety and immunogenicity of a WT1 vaccine comprised of four class I and class II peptides in patients with thoracic neoplasms expressing WT1. METHODS: Therapy consisted of six subcutaneous vaccinations administered with Montanide adjuvant on weeks 0, 4, 6, 8, 10, and 12, with 6 additional monthly injections for responding patients. Injection sites were pre-stimulated with GM-CSF (70 mcg). Immune responses were evaluated by DTH, CD4 T-cell proliferation, CD8 T-cell interferon gamma release, intracellular cytokine staining, WT1 peptide MHC-tetramer staining, and cytotoxicity against WT1 positive tumor cells. RESULTS: Nine patients with MPM and 3 with NSCLC were vaccinated, with 8 patients receiving at least 6 vaccinations; in total, 10 patients were evaluable for immune response. Six out of nine patients tested demonstrated CD4 T-cell proliferation to WT1 specific peptides, and five of the six HLA-A0201 patients tested mounted a CD8 T-cell response. Stimulated T cells were capable of cytotoxicity against WT-1 positive cells. Vaccination also induced polyfunctional CD8 T cell responses. CONCLUSIONS: This multivalent WT1 peptide analog vaccine induces immune responses in a high proportion of patients with thoracic malignancies with minimal toxicity. A randomized trial testing this vaccine as adjuvant therapy in MPM is planned.

Analysis of GD2/GM2 synthase mRNA as a biomarker for small cell lung cancer.

BACKGROUND: GD2/GM2 synthase is a key enzyme in the synthesis of GD2 and GM2 gangliosides found on the surface of neuroblastoma and small cell lung carcinoma (SCLC) cells. In neuroblastoma, persistent levels of GD2/GM2 synthase RNA in bone marrow (BM) following therapy portend poorer progression-free and overall survival. We conducted this study to determine if GD2/GM2 synthase RNA could be detected in SCLC cell lines and human tissues, and whether mRNA transcript levels corresponded with disease status. EXPERIMENTAL DESIGN: Initially, a pilot study enrolled patients with SCLC to determine the rate of GD2 expression at various points in the patients' disease course. Peripheral blood (PB), bone marrow and tumor tissues were used to measure GD2/GM2 synthase levels. In addition, SCLC cell lines were analyzed for GD2/GM2 synthase expression. Based on data from that initial analysis, a prospective trial was developed enrolling patients with newly diagnosed SCLC and following them serially. GD2/GM2 synthase transcript was determined by a sensitive quantitative reverse transcription-PCR (qRT-PCR) assay and normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH). RESULTS: Six SCLC cell lines were assayed for expression of GD2/GM2 synthase, and high expression was detected in all. GD2/GM2 synthase transcript levels were obtained from tumor tissue, BM, or PB of 29 patients in the pilot study. 6/10 (60%) tumor tissues or BM samples were positive (median 332.7 units; range 13-2323 units); 8/19 (42%) untreated patients were GD2/GM2 synthase positive in their PB prior to beginning therapy (median 10.2; range 5.1-32.2); 3/4 (75%) patients who were first tested when they developed recurrent disease were positive in their PB (median 16.1; range 8.5-19.9). The fourth patient had an initial value of 2.0 (negative), which increased to 8.4 (positive) within 1 month without treatment. Seven of 12 patients with baseline positive GD2/GM2 synthase values had post-treatment levels measured, all of which were 50% decrease following successful treatment. Patients in the prospective trial demonstrated lower rates of positivity, with only 3/26 (12%) patients exhibiting detectable transcript levels in the peripheral blood prior to treatment. All 3 of these patients had their transcript levels fall below 5 after treatment. 11/26 patients had baseline levels of zero. Bone marrow was drawn at baseline on 7 patients in the prospective trial and 3 (43%) had transcript levels above 5 (range 0.65-27.43 units). There was no correlation between elevated levels in the BM and elevated levels in the PB. CONCLUSIONS: Although initial studies demonstrated that GD2/GM2 synthase transcripts were measurable in the peripheral blood of SCLC patients at diagnosis and declined with successful treatment, in a separate prospective study, these results could not be confirmed. Thus, GD2/GM2 is not a reliable biomarker in SCLC.