Morton Plant Mease

As reimbursement from the Medicare Physician Fee Schedule (PFS) continues to decline, cuts to practice expense relative value units disproportionately impact office-based interventionalists and private practices that rely on high-cost equipment. For 195 codes, specialties such as radiation oncology, vascular surgery, and interventional radiology are paid at rates less than their direct costs calculated by the Centers for Medicare and Medicaid Services itself. While reimbursement in the office-based setting continues to decline, high-cost hospital settings receive more payment for the same services. This disparity aligns with trends in care moving to the hospital setting and practice consolidation, resulting in increased costs to the healthcare system and decreased access to care. The current PFS is outdated, and the removal of high-cost supplies and equipment from the PFS is a critical step to reform.

ABSTRACT We established a Geriatrics Workforce Enhancement Program (GWEP) clinic to enhance resident training on comprehensive preventive care and chronic disease management, and to increase the number of older patients who received Medicare Annual Wellness Visit (AWV) preventive services. A total of 1,104 patients were tracked at baseline and during the intervention period. Patients were grouped into two categories: Adult (aged 55–64) and Senior (aged 65+). Clinical quality measures were monitored by electronic health record and tracked through monthly reports at baseline (May 2018) and during the intervention period (July 2018-June 2019). In the Senior group, the proportion of patients receiving the Medicare AWV increased after GWEP began (p <.001). Additionally, the Senior group showed significant improvements in the frequency of body mass index assessments (p = .04), colorectal cancer screenings (p < .001), advance directive documentation (p < .001), cognitive screenings (p < .001), and pneumococcal vaccinations (p < .001). In the Adult group, a trending increase was seen in influenza vaccinations (p = .06). Curricular innovations including the establishment of a GWEP clinic in our residency outpatient center, development of new educational materials, and use of a nurse coordinator resulted in significant improvements in the percentage of older adults who received the Medicare AWV benefit and preventive health performance metrics.

To our knowledge, REPRISE III is the first large randomized comparison of 2 different transcatheter aortic valve replacement platforms: the mechanically expanded Lotus valve (Boston Scientific) and self-expanding CoreValve (Medtronic). To evaluate outcomes of Lotus vs CoreValve after 2 years. A total of 912 patients with high/extreme risk and severe, symptomatic aortic stenosis enrolled between September 22, 2014, and December 24, 2015, were randomized 2:1 to receive Lotus (607 [66.6%]) or CoreValve (305 [33.4%] at 55 centers in North America, Europe, and Australia. The first 2-year visit occurred on October 17, 2016, and the last was conducted on April 12, 2018. Clinical and echocardiographic assessments are complete through 2 years and will continue annually through 5 years. All-cause mortality and all-cause mortality or disabling stroke at 2 years. Other clinical factors included overall stroke, disabling stroke, repeated procedures, rehospitalization, valve thrombosis, and pacemaker implantation. Echocardiographic analyses included effective orifice area, mean gradient, and paravalvular leaks (PVLs). Of 912 participants, the mean (SD) age was 82.8 (7.3) years, 465 (51%) were women, and the mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 6.8% (4.0%). At 2 years, all-cause death was 21.3% with Lotus vs 22.5% with CoreValve (hazard ratio [HR], 0.94; 95% CI, 0.69-1.26; P = .67) and all-cause mortality or disabling stroke was 22.8% with Lotus and 27.0% with CoreValve (HR, 0.81; 95% CI, 0.61-1.07; P = .14). Overall stroke was 8.4% vs 11.4% (HR, 0.75; 95% CI, 0.48-1.17; P = .21); disabling stroke was more frequent with CoreValve vs Lotus (4.7% Lotus vs 8.6% CoreValve; HR, 0.53; 95% CI, 0.31-0.93; P = .02). More Lotus patients received a new permanent pacemaker (41.7% vs 26.1%; HR, 1.87; 95% CI, 1.41-2.49; P < .01) or had a valve thrombosis (3.0% vs 0.0%; P < .01) compared with CoreValve. More patients who received CoreValve experienced a repeated procedure (0.6% Lotus vs 2.9% CoreValve; HR, 0.19; 95% CI, 0.05-0.70; P < .01), valve migration (0.0% vs 0.7%; P = .05), or embolization (0.0% vs 2.0%; P < .01) than Lotus. Valve areas remained significantly larger and the mean gradient was lower with CoreValve than Lotus (valve area, mean [SD]: Lotus, 1.53 [0.49] cm2 vs CoreValve, 1.76 [0.51] cm2; P < .01; valve gradient, mean [SD]: Lotus, 13.0 [6.7] mm Hg vs 8.1 [3.7] mm Hg; P < .01). Moderate or greater PVL was more frequent with CoreValve (0.3% Lotus vs 3.8% CoreValve; P < .01) at 2 years. Larger improvements in New York Heart Association (NYHA) functional class were observed with Lotus compared with CoreValve (improved by ≥1 NYHA class: Lotus, 338 of 402 [84.1%] vs CoreValve, 143 of 189 [75.7%]; P = .01; improved by ≥2 NYHA classes: 122 of 402 [37.3%] vs 65 of 305 [21.3%]). After 2 years, all-cause mortality rates, mortality or disabling stroke were similar between Lotus and CoreValve. Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm. clinicaltrials.gov Identifier: NCT02202434.

OBJETIVO: Avaliar as dificuldades na amamentação em 50 puérperas na Maternidade da Fundação Santa Casa de Misericórdia e o apoio recebido do Banco de Leite. METODOLOGIA: Trata-se de um estudo Descritivo, observacional, transversal. O trabalho foi realizado na Maternidade da Fundação Santa casa de Misericórdia do Pará nas enfermarias de puerpério. RESULTADOS: A dificuldade no aleitamento materno encontrada foi a não apojadura do leite, seguida de mamilo invertido bilateralmente, fissura nos mamilos e dificuldade na sucção. A idade das puérperas foi de 25,54 anos; a maioria era de zona urbana e residente na capital paraense, cursava o ensino médio, tinha companheiro, não planejara a presente gravidez, era primigesta, realizara pré-natal com 6 ou mais consultas e em algum momento fora conversado sobre amamentação. A maioria tiveram seus filhos por via cesariana, transcorrendo o parto sem problemas, sendo a média vida dos neonatos no momento da pesquisa de 36,64 horas. Todas as pacientes pretendiam amamentar seus filhos da presente gestão, e a maioria delas sabe da importância do aleitamento materno e acredita que pode ser em regime exclusivo por no mínimo 6 meses. Quase a totalidade das puérperas já tinham recebido auxílio do banco de leite e a maior parte delas se sentiu segura após tal suporte. CONCLUSÃO: A amamentação é um processo importantíssimo no desenvolvimento mãe-bebê e identificar o que mais dificulta esse processo é fundamental para uma adequada assistência e nesse sentido os bancos de leite entram como principal trunfo nos hospitais de referência como o do estudo.

Abstract Introduction: Biospecimen donation and banking from diverse populations are critical for translational cancer research. Yet, little is known about community members’ perceptions about biospecimen donation and banking. The objectives of this study are to develop instruments to examine perceptions of biospecimen donation and banking and evaluate the efficacy of biobanking educational materials. Methods: Guided by a community-based participatory research (CBPR) approach, the study consists of two phases. In phase I, an instrument named Biobanking Attitudes and Knowledge Survey (BANKS) was developed in collaboration with the Tampa Bay Community Cancer Network (TBCCN) Biobanking Community Advisory Board to assess participants’ knowledge about and attitudes towards biospecimen collection, intention to donate biospecimens to a biobank, as well as self-efficacy regarding biospecimen donation. BANKS development and validation consists of iterative processes, including content analysis of 12 focus groups (n=95) for item generation; cognitive interviews (n=12 community members) to assess item comprehension and language appropriateness; content validity analyses with biobanking experts (n=5) to evaluate item relevancy to the constructs of interest (Knowledge, Attitudes and Self-efficacy); pilot-testing with community members; and instrument translation into Spanish. In Phase II, a small randomized control trial will be conducted with 60 community members to assess the efficacy of biobanking educational materials in increasing knowledge, positive attitudes, self-efficacy, and intentions to donate biospecimens to a biobank. The study will compare a multimedia biobanking educational intervention developed by TBCCN, with the National Cancer Institute brochure titled Providing Your Tissue for Research: What You Need to Know (NCI brochure). BANKS data will be collected following study enrollment (baseline), and then participants will be randomly assigned to one of two intervention groups (TBCCN multimedia intervention or NCI brochure). Follow-up interviews using the BANKS will be conducted between 7 and 14 days after enrollment. Participants’ medical records will be reviewed to assess group differences in biospecimen donation consent rates. Results: Using a CBPR approach, the project has successfully developed and validated a culturally and linguistically appropriate instrument to assess community members’ knowledge, attitudes, intention, and self-efficacy related to biospecimen donation. The BANKS is comprised of 21 attitudes items, 17 knowledge items, 11 self-efficacy items, and 2 intention items. Phase II of the study is expected to provide preliminary data on the efficacy of a multimedia biobanking educational intervention in improving perceptions of biospecimen donation and biobanking. Conclusion: Using a CBPR approach, data collected during this study have yielded a culturally appropriate instrument to assess community members’ perceptions about biobanking, the BANKS. The next step in the study is to use the BANKS to evaluate a multimedia biobanking intervention in increasing knowledge, positive attitudes, self-efficacy, and intention to donate biospecimens to a biobank among racial/ethnically and linguistically diverse populations in Tampa Bay, Florida. Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):B8.

Abstract Background: Data on the clinical cutoff and validation trials of the Breast Lymph Node (BLN) Assay were presented at the San Antonio Breast Cancer Symposia in 2006 and 2007. These trials led to FDA approval on July 17, 2007 as a stand alone test for intraoperative decision-making for complete axillary node dissection (cALND) on patients with invasive breast cancer. The goal of intraoperative assays is to reduce the 2nd surgery cALND, but also not to perform cALND on non-clinically significant disease by current staging (N0 (i+) or ITCs). This report is the initial post-market clinical data on 391 consecutive cases of invasive breast cancer from a single institution, single surgeon experience.Methods: The sentinel lymph nodes (SLN) were examined using the FDA approved cutting scheme. 50% of each node (alternating slices) was homogenized &amp; analyzed by real-time RT-PCR markers: cytokeratin 19 &amp; mammaglobin. Typically the BLN assay gives a qualitative result (pos/neg), but can provide quantitative values, currently for research use only. Only the on-label qualitative result was used for patient management. Remaining slices were submitted for frozen section (FS) &amp; permanent section H&amp;E (PS). All patients that were positive by FS, PS or the BLN assay had cALND.Results: The BLN assay performance in clinical use compared to PS on SLNs is similar to trial data: sensitivity 92% &amp; specificity 92%. FS performance compared to PS is sensitivity 68% &amp; specificity 99%; low sensitivity is in part due to an increase of micromets. Assay turn around time is 36 min. 89 patients had cALNDs. BLN Assay qualitative results have similar PPV to PS but greater NPV. Looking at factors commonly in nomograms (age, tumor size, grade, PS results and ER/PR/HER2 status) to predict cALND positivity none had statistical significance, but the ROC curve for all these factors together (baseline) had a 0.69 AUC. Comparatively BLN assay quantitative results were statistically significant &amp; produce a ROC curve with 0.72 AUC. When BLN assay is added to baseline, no variables are statistically significant, mostly due to small sample size, but AUC increases (0.75). However the ROC curve seems most promising with BLN assay alone (Figure 1). More data is needed for statistical significance.Discussion: Although there are many nomograms &amp; clinical prediction rules published, often all the data points are not available intraoperatively &amp; have limited reliability. The alternative is to wait for PS &amp; then decide whom to bring back for further surgery. This leads to increased cost, stress on the patient &amp; staff if another procedure is recommended. Conversely, a prediction rule that can help decide when not to proceed to a cALND even with SLN positivity would be extremely useful. The BLN Assay offers a good prediction of ALND positivity that adds value when added to other risk factors &amp; may add the same or more value alone intraoperatively. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1016.

Abstract Abstract #1002 The GeneSearch™ Breast Lymph Node (BLN) Assay (Veridex, LLC) has been FDA approved to detect metastases &amp;gt; 0.2 mm in the sentinel lymph nodes (SLNs) of breast cancer patients and has been in clinical use in our institute for 11 months. This assay gives a qualitative (negative/positive) result by applying cutoff values to the cycle times (Ct) of the two mRNA markers analyzed: mammaglobin (MG) (cutoff value = 31 Cts) and cytokeratin 19 (CK19) (cutoff value = 30 Cts). This is the first study to evaluate if the quantitative Ct values of MG and CK19 can be used to estimate probable size of nodal metastases.&amp;#x2028; To date 184 patients have been tested using the BLN Assay during its clinical use at Morton Plant Hospital. An additional 172 patients were tested with the BLN Assay at our institute during investigational studies. In both cases, the SLNs of breast cancer patients were divided into ∼2 mm pieces. Alternating pieces were homogenized and were processed intra-operatively. The other pieces of the SLN were used for permanent section H&amp;E analysis. The patient was considered H&amp;E positive when a metastasis &amp;gt; 0.2 mm was identified. During clinical use, same-surgery complete axillary dissection was performed when the assay was positive (n = 34).&amp;#x2028; Performance of the assay's qualitative result against permanent section H&amp;E on adjacent node pieces was similar for the two groups (total N = 356), for a total sensitivity of 96% (81/84), specificity of 93% (254/272), and overall agreement of 94%. The marker Ct values correlated with metastases size as determined by H&amp;E in adjacent node pieces (r = 0.74 for MG and 0.72 for CK19, p &amp;lt; .0001). The lower the Ct values, the greater the likelihood of macrometastases reported by H&amp;E, as described in Table 1. For example if CK19 is &amp;lt;21.0 and MG is &amp;lt; 25.0, there is 100% chance for H&amp;E positivity in the SLNs, with the majority being macrometastases.&amp;#x2028; &amp;#x2028; Additionally, BLN Assay Ct values in the SLN were predictive of metastases in the non-SLN nodes. For example, of the 12 patients who had a SLN with CK19 &amp;lt; 24 Cts, 9 (75%) had H&amp;E positive non-SLNs. For the same 12 patients, SLNs were H&amp;E positive (5 macrometastases, 5 micrometastases, and 2 reported as &amp;gt; 0.2 mm).&amp;#x2028; The BLN Assay's high intra-operative qualitative performance minimizes the need for second surgeries for complete axillary dissections. Results from this investigational study examining the marker Ct values suggest that the assay may provide valuable individual tumor volume data intra-operatively or post-operatively. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 1002.