Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF)

In that study, incremental reductions in the PA pressures in the monitored arm were associated with both reduction in the frequency of HFH and improvements in health-related quality of life among patients with both preserved (HFpEF) and reduced ejection fraction (HFrEF).3,4 Additionally, hemodynamic-guided HF management in the subset of HFrEF patients treated with guideline-directed medical therapy (GDMT) was associated with a strong trend toward improved survival compared to traditional clinical management.4,7 Consistent benefit is demonstrated in several retrospective studies from the CHAMPION Trial.10-13 as well as extensive analysis of “real-world� experience.6,14 and in Medicare claims data managed in a commercial setting.5,15 Whether the benefits of PA pressure guided therapy can be extended to a broader pool of patients with milder (NYHA class II) or more severe (NYHA class IV) HF or to those without recent hospitalization for HF but with elevation in natriuretic peptide levels remains unclear. Remotely uploaded PA pressure information from the control group will be blocked from investigator review. [...]other than medication changes resulting from information from RHC procedures, control group subjects will not have pressure-based medication changes over time and should be managed instead according to routine practice as informed by published clinical guidelines. Thresholds for NT-proBNP/BNP corrected for BMI using a 4% reduction per BMI unit over 25 kg/m2 Subjects ≥18 y of age able and willing to provide informed consent Chest circumference of 15) at implant RHC, a history of noncompliance, or any condition that would preclude CardioMEMS PA Sensor implantation Table I Inclusion and exclusion criteria PA pressure goals PA diastolic: 8-20 mm Hg PA mean: 10-25 mm Hg PA systolic: 15-35 mm Hg Optimization phas

Beyond Dunsmuir: Clarity on the Standard of Review from Saguenay

Diana Ginn and Gregory Johannson The recent Supreme Court of Canada decision Mouvement laique qudbicois v. Saguenay (City) is a noteworthy administrative law case, providing meaningful guidance on applying the standard of review analysis from New Brunswick (Board of Management) v. Dunsmuir. Two aspects of Saguenay in particular contribute to the development of administrative law jurisprudence. First, Saguenay confirms that general questions of law that are of central importance to the legal system as a whole and outside the adjudicator\u27s specialized area of expertise do in fact exist and are not merely a theoretical category. Second, the majority decision seems to lay to rest the notion that disaggregation of issues is never appropriate; sometimes it will be legitimate to separate out different aspects of an administrative decision and apply different standards of review. Other elements of Saguenay are useful confirmations of established administrative law principles. These include the importance accorded to the nature of the question in the determination of standard of review and the unified approach to be taken to all substantive review of administrative decision making, irrespective of whether a decision is challenged by way of judicial review or statutory appeal

Beyond Dunsmuir: Clarity on the Standard of Review from Saguenay

Diana Ginn and Gregory Johannson The recent Supreme Court of Canada decision Mouvement laique qudbicois v. Saguenay (City) is a noteworthy administrative law case, providing meaningful guidance on applying the standard of review analysis from New Brunswick (Board of Management) v. Dunsmuir. Two aspects of Saguenay in particular contribute to the development of administrative law jurisprudence. First, Saguenay confirms that general questions of law that are of central importance to the legal system as a whole and outside the adjudicator\u27s specialized area of expertise do in fact exist and are not merely a theoretical category. Second, the majority decision seems to lay to rest the notion that disaggregation of issues is never appropriate; sometimes it will be legitimate to separate out different aspects of an administrative decision and apply different standards of review. Other elements of Saguenay are useful confirmations of established administrative law principles. These include the importance accorded to the nature of the question in the determination of standard of review and the unified approach to be taken to all substantive review of administrative decision making, irrespective of whether a decision is challenged by way of judicial review or statutory appeal

Abstract 3266: Oral rinse point of care test to predict head and neck cancer

Abstract Background: Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cause of cancer mortality throughout the world affecting some 50,000 people in the US and 600,000 worldwide each year. The ability to detect the disease in a potentially malignant phase and earlier stage could have significant impact on overall outcome. Previous studies have demonstrated that a combined salivary CD44, a tumor-initiating marker, and total protein assay was able to aid in the diagnosis of HNSCC. We sought to understand the performance characteristics of these biomarkers in a prospective population using a qualitative, point-of-care assay (POC) which consists of a cassette with a colorimetric read-out based on a pre-determined threshold for both CD44 and total protein. We also performed results from same samples with a quantitative lab-based test. Methods: Saline oral rinse specimens (~5ml) from 134 patients (84 HNSCC cases; 50 controls) were obtained from biorepositories. Samples were thawed, gently swirled, placed in a standard collection cup. 600ul were removed for lab assay prior to POC test. The tapered end of the POC cassette was submerged in rinse for 20’; levels of CD44 and total protein (TP) were evaluated by two operators. POC test results were compared between operators and with lab test results using Cohen’s kappa coefficient and McNemar’s test, sensitivity(Se), specificity(Sp), NPV and PPV. Results: 95% HNSCC patients (cases) were mean 60 years of age, 60% male, 97% white and 74% smokers vs. 43 years, 28%, 96% and 0% respectively, for controls. POC was positive with either CD44 or TP above threshold. Weighted kappa yielded 75% and 72% for CD44 and TP respectively between operators. With a prevalence of 9.27: POC: NPV 94%, PPV 10%; variable TP cut-off produced Se71-84% and Sp30%-50%. McNemar and Kappa for both lab CD44 and TP vs POC indicated moderate agreement; independently both POC and lab produced NPV &amp;gt;90%. Conclusions: Concordance of the POC assay between operators and moderate agreement with a quantitative lab assay provides supportive evidence for clinical application of the POC assay as an aid in the diagnosis for HNSCC. Additional studies are underway to confirm these observations. Citation Format: Michael J. Donovan, Kris Curtis, Greg Ginn, Elizabeth J. Franzmann. Oral rinse point of care test to predict head and neck cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 3266. doi:10.1158/1538-7445.AM2017-3266</jats:p

Remote hemodynamic-guided therapy of patients with recurrent heart failure following cardiac resynchronization therapy

Background: Patients with recurring heart failure (HF) following cardiac resynchronization therapy fare poorly. Their management is undecided. We tested remote hemodynamic-guided pharmacotherapy. Methods and Results: We evaluated cardiac resynchronization therapy subjects included in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association Class III Heart Failure Patients) trial, which randomized patients with persistent New York Heart Association Class III symptoms and ≥1 HF hospitalization in the previous 12 months to remotely managed pulmonary artery (PA) pressure-guided management (treatment) or usual HF care (control). Diuretics and/or vasodilators were adjusted conventionally in control and included remote PA pressure information in treatment. Annualized HF hospitalization rates, changes in PA pressures over time (analyzed by area under the curve), changes in medications, and quality of life (Minnesota Living with Heart Failure Questionnaire scores) were assessed. Patients who had cardiac resynchronization therapy (n=190, median implant duration 755 days) at enrollment had poor hemodynamic function (cardiac index 2.00±0.59 L/min per m2), high comorbidity burden (67% had secondary pulmonary hypertension, 61% had estimated glomerular filtration rate /min per 1.73 m2), and poor Minnesota Living with Heart Failure Questionnaire scores (57±24). During 18 months randomized follow-up, HF hospitalizations were 30% lower in treatment (n=91, 62 events, 0.46 events/patient-year) versus control patients (n=99, 93 events, 0.68 events/patient-year) (hazard ratio, 0.70; 95% CI, 0.51-0.96; P=0.028). Treatment patients had more medication up-/down-titrations (847 versus 346 in control, PP=0.002), and quality of life improvement (Minnesota Living with Heart Failure Questionnaire decreased -13.5±23 versus -4.9±24.8 in control, P=0.006). Conclusions: Remote hemodynamic-guided adjustment of medical therapies decreased PA pressures and the burden of HF symptoms and hospitalizations in patients with recurring Class III HF and hospitalizations, beyond the effect of cardiac resynchronization therapy. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00531661