The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction.

OBJECTIVE: To assess safety and feasibility of autologous adipose-derived regenerative cells (ADRCs), for treatment of chronic ischemic cardiomyopathy patients. BACKGROUND: Preclinical and early clinical trials suggest ADRCs have excellent potential for ischemic conditions. METHODS: The Athena program consisted of two parallel, prospective, randomized (2:1, active: placebo), double-blind trials assessing intramyocardial (IM) ADRC delivery [40-million, n = 28 (ATHENA) and 80-million (ATHENA II) cells, n = 3]). Patients with an EF ≥20% but ≤45%, multivessel coronary artery disease (CAD) not amenable to revascularization, inducible ischemia, and symptoms of either angina (CCS II-IV) or heart failure (NYHA Class II-III) on maximal medical therapy were enrolled. All patients underwent fat harvest procedure (≤450 mL adipose), on-site cell processing (Celution® System, Cytori Therapeutics), electromechanical mapping, and IM delivery of ADRCs or placebo. RESULTS: Enrollment was terminated prematurely due to non-ADRC-related adverse events and subsequent prolonged enrollment time. Thirty-one patients (17-ADRCs, 14-placebo) mean age 65 ± 8 years, baseline LVEF(%) 31.1 ± 8.7 (ADRC), 31.8 ± 7.7 (placebo) were enrolled. Change in V02 max favored ADRCs (+45.4 ± 222 vs. -9.5 ± 137 mL/min) but there was no difference in left ventricular function or volumes. At 12-months, heart failure hospitalizations occurred in 2/17 (11.7%) [ADRC] and 3/14 (21.4%) [placebo]. Differences in NYHA and CCS classes favored ADRCs at 12-months with significant improvement in MLHFQ (-21.6 + 13.9 vs. -5.5 + 23.8, P = 0.038). CONCLUSIONS: A small volume fat harvest, automated local processing, and IM delivery of autologous ADRCs is feasible with suggestion of benefit in "no option" CAD patients. Although the sample size is limited, the findings support feasibility and scalability for treatment of ischemic cardiomyopathy with ADRCs. © 2016 Wiley Periodicals, Inc.

Validation of the RightLevelpH Detector for Monitoring Gastric pH.

BACKGROUND: The RightLevelpH indicator is a new device designed to measure the pH of gastric aspirate obtained via a nasogastric tube while minimizing exposure of the operator. OBJECTIVE: To validate the RightLevelpH indicator in vivo and in vitro. METHODS: With general anesthesia, 20 patients had placement of a nasogastric tube and a gastric pH electrode catheter after endotracheal intubation. Direct intragastric pH was recorded simultaneously with gastric aspirate pH by using the RightLevelpH indicator and by using an external pH electrode. Measurements were made every 30 minutes until removal of the nasogastric tube as indicated clinically. In vitro validation of the RightLevelpH indicator was performed by using standard buffer solutions. RESULTS: The pH of clear buffer solutions was linearly related to pH determined by the RightLevelpH indicator (R(2) = 0.99; P < .001). The pH of gastric aspirate determined with an external pH electrode was linearly related to the gastric aspirate pH determined by using the RightLevelpH indicator (R(2) = 0.92; P < .001). Intragastric pH determined with the catheter electrode was also linearly related but more loosely correlated with gastric aspirate pH determined by using an external pH electrode (R(2) = 0.52; P < .001) and by the RightLevelpH indicator (R(2) = 0.55; P < .001). CONCLUSIONS: The RightLevelpH indicator provides accurate measurements of the pH of gastric aspirate in patients.

Validation of the RightSpot™ device for determination of gastric pH during nasogastric tube placement.

BACKGROUND: The RightSpotpH™ indicator is a new device designed to facilitate pH-based confirmation of nasogastric tube placement while minimizing exposure of the operator to nasogastric contents. STUDY OBJECTIVES: In vivo and in vitro validation of the RightSpotpH™ indicator. FINDINGS: Patients (23) undergoing general anesthesia had placement of a nasogastric tube and gastric pH electrode catheter following endotracheal intubation. Direct intragastric pH was recorded simultaneously with gastric aspirate pH using the RightSpotpH™ indicator as well as an external pH electrode. In vitro validation of the RightSpotpH™ indicator was performed using standard buffer solutions. Electrode catheter-determined intragastric pH was compared to the RightSpotpH™ indicator result (pH greater or less than 4.5) as was aspirate pH using an external pH electrode. The positive predictive value for the RightSpotpH™ indicator was 0.92 (95% CI 0.62-0.99) and negative predictive value was 1.0 (95% CI 0.48-1.0) when compared to the direct catheter intragastric pH determination. This corresponds to a sensitivity of 1.0 and specificity of 0.83. The positive predictive value for the RightSpotpH™ indicator was 1.0 (95% CI 0.29-0.99) and negative predictive value was 0.75 (95% CI 0.19-0.99) when compared to the external pH electrode determination of aspirate. This corresponds to a sensitivity of 0.91 and specificity of 1.0. Blinded in vitro testing of 46 buffer solution samples of pH 2-7 yielded sensitivity and specificity for correct pH discrimination of 1.0 and 1.0. CONCLUSIONS: The RightSpotpH™ indicator is sensitive and specific for determination of intragastric pH determination as less than or greater than 4.5 as commonly used for nasogastric tube placement.

An academic-community cardiovascular service line affiliation: design, implementation, and performance.

Both affiliation with an academic medical center and implementation of service line management may be effective management strategies for community health care organizations. The authors describe the design, implementation, and performance of a unique combination of these two distinct strategies for cardiovascular program development in the affiliation of the University of Florida Health Science Center with Health First, a regional community-based integrated delivery system.

Some thoughts on the vasculopathy of women with ischemic heart disease.

Considerable experimental and clinical data indicate that sex has an important influence on cardiovascular physiology and pathology. This report integrates selected literature with new data from the Women's Ischemia Syndrome Evaluation (WISE) on vascular findings in women with ischemic heart disease (IHD) and how these findings differ from those in men. A number of common vascular disease-related conditions are either unique to (e.g., hypertensive disorders of pregnancy, gestational diabetes, peripartum dissection, polycystic ovarian syndrome, etc.) or more frequent (e.g., migraine, coronary spasm, lupus, vasculitis, Raynaud's phenomenon, etc.) in women than men. Post-menopausal women more frequently have many traditional vascular disease risk conditions (e.g., hypertension, diabetes, obesity, inactivity, and so on), and these conditions cluster more frequently in them than men. Considerable evidence supports the notion that, with these requisite conditions, women develop a more severe or somewhat different form of vascular disease than men. Structurally, women's coronary vessels are smaller in size and appear to contain more diffuse atherosclerosis, their aortas are stiffer (fibrosis, remodeling, and so on), and their microvessels appear to be more frequently dysfunctional compared with men. Functionally, women's vessels frequently show impaired vasodilator responses. Limitations of existing data and higher risks in women with acute myocardial infarction, need for revascularization, or heart failure create uncertainty about management. A better understanding of these findings should provide direction for new algorithms to improve management of the vasculopathy underlying IHD in women.