1,720,966 research outputs found
Twelve-month follow-up results from the SIRONA 2 clinical trial
No full textAimsIn the SIRONA 2 trial, the safety and efficacy of pulmonary artery (PA) pressure (PAP)-guided heart failure (HF) management using a novel PAP sensor were assessed at 30 and 90 days, respectively, and both endpoints were met. The current study examines the prespecified secondary endpoints of safety and accuracy of the PA sensor along with HF hospitalizations and mortality, HF symptoms, functional capacity, quality of life, and patient compliance through 12 months. Methods and resultsSIRONA 2 is a prospective, multi-centre, open-label, single-arm trial evaluating the Cordella (TM) PA Sensor System in 70 patients with New York Heart Association (NYHA) functional class III HF with a prior HF hospitalization and/or increase of N-terminal pro-brain natriuretic peptide within 12 months of enrolment. Sensor accuracy was assessed and compared with measurements obtained by standard right heart catheterization (RHC). Safety was defined as freedom from prespecified adverse events associated with use of the Cordella PA Sensor System and was assessed in all patients who entered the cath lab for PA sensor implant. HF hospitalizations and mortality, HF symptoms, functional capacity, quality of life, and patient compliance were also assessed. At 12 months, there was good agreement between the Cordella PA Sensor System and RHC, with the average difference for mean PAP being 2.9 +/- 7.3 mmHg. The device safety profile was excellent with 98.4% freedom from device/system-related complications. There were no pressure sensor failures. HF hospitalizations and mortality were low with a rate of 0.33 event per patient year. Symptoms as assessed by NYHA (P < 0.0001) and functional capacity as measured by 6 min walk test (P = 0.02) were significantly improved. Patients' adherence to daily transmissions of PAP and vital signs measurements was 95%. ConclusionsLong-term follow-up of the SIRONA 2 trial supports the safety and accuracy of the Cordella PA Sensor System in enabling comprehensive HF management in NYHA class III HF patients.Endotronix In
Feasibility of Continuous Noninvasive Pulmonary Artery Pressure Monitoring via the Cordella Implantable Pulmonary Artery Sensor
No full textAlthough cardiopulmonary exercise testing (CPET) is considered the gold standard assessment of functional capacity and prognosis in heart failure (HF) patients, pulmonary hemodynamics can be measured during incremental exercise at invasive right heart catheterization or noninvasively at exercise echocar-diography to assess the physiologic responses to exercise and help guide patient management. 1,2 The Cordella PA sensor (Endotronix Inc) transmits pulmonary artery pressures (PAPs) from HF patients to their clinical team, and a harness was developed to allow for hands-free continuous PAP readings. The results of a feasibility study of HF patients who underwent Cordella PA sensor implant and subsequent 6-minute walk test (6MWT) with continuous PAP readings are reported here. The SIRONA 2 clinical trial has been previously described. 3 The study was undertaken in accordance with the Declaration of Helsinki and approved by the relevant competent authorities and independent ethics committees. All patients provided written informed consent. At a follow-up visit, each participant underwent the Cordella 6MWT protocol. To begin, patients assumed a seated position. The reader was then activated to begin recording continuous PAP, a timer was started, and the patients rested for 5 minutes. Then, blood pressure (BP), oxygen saturation (SpO 2), and the Borg Rating and Perceived Exertion (RPE) scale were assessed. Patients then stood for 1 minute before performing the 6MWT. Following the 6MWT, patients were asked to sit, and BP, SpO 2 , and Borg RPE were assessed. Following at least 5 minutes of sitting, BP, SpO 2 , and Borg RPE were assessed again, and the timer and reader were stopped. Continuous PAP waveform processing was performed in LabVIEW Runtime version 2019 (National Instruments) (Figure 1A). Heart rate was derived from the PAP waveform. The 10-second periods before each minute in the test were averaged for both PAP and heart rate for the purposes of plotting and comparing timepoints within the test (Figure 1B). Data are reported as median with IQR. Changes in parameters were compared using repeated-measures Student's t-tests with a significance threshold of P < 0.05. Twelve subjects underwent the Cordella 6MWT with successful continuous PAP measurement. At baseline, the median age was 71.0 years (Q1-Q3: 68.5-74.8 years), 7 (58.3%) were male, and they had a median 6MWT of 370.0 m (Q1-Q3: 321.5-403.5 m). All had NYHA functional class III at baseline but had progressed to NYHA functional class II at the time of the 6MWT. Patients underwent the 6MWT protocol a median of 552 days (Q1-Q3: 379-1,054 days) from implant. The median distance walked was 336.0 m (Q1-Q3: 292.3-389.8 m). Measurement of all hemody-namic variables was feasible in all subjects during the entire study protocol, and PAP was continuously recorded for a minimum of 17 minutes in all cases. PA pressures and heart rate increased significantly during the 6MWT (systolic: þ29.2 mm Hg [Q1-Q3: 23.1-34.7 mm Hg]; diastolic: þ13.2 mm Hg [Q1-Q3: 9.9-16.4 mm Hg]; mean: þ21.1 mm Hg [Q1-Q3: 9.9-16.4 mm Hg]; heart rate: þ24.0 beats/min [Q1-Q3: 18.0-36.0 beats/min]; all values of P < 0.05) and What is the clinical question being addressed? Whether continuous, noninvasive PAP measurement during ambulatory exercise is feasible using an implantable PA sensor. What is the main finding? Continuous, noninvasive PAP measurement using the Cordella PA Sensor system is feasible in HF patients during exercise
Safety and efficacy of a wireless pulmonary artery pressure sensor: primary endpoint results of the SIRONA 2 clinical trial
No full textAbstract Aims Implantable pulmonary artery pressure (PAP) sensors have been shown to reduce heart failure hospitalizations (HFH) in selected patients. The goal of this study was to evaluate the safety and efficacy of a novel wireless PAP monitoring system in patients with heart failure (HF). Methods and results This is a prospective, multi‐centre, open‐label, single‐arm trial evaluating the safety and efficacy of the Cordella™ PA Sensor System including the comprehensive Cordella™ Heart Failure System (CHFS) in patients with New York Heart Association (NYHA) Class III heart failure with a heart failure hospitalization and/or increase of N‐terminal pro‐Brain Natriuretic Peptide (NT‐proBNP) within 12 months of enrolment. The primary efficacy endpoint was the accuracy of PA sensor mean PAP measurements, compared with fluid‐filled catheter mean PAP measurements obtained by standard right heart catheterization (RHC) at 90 days post‐implant, assessed in all patients with a successful implant. The primary safety endpoint was freedom from adverse events associated with use of the Cordella PA Sensor System through 30 days post‐implant, assessed in all patients who entered the cath lab for PA sensor implant. The PA sensor was successfully implanted in 70 patients. Equivalence between the PA sensor and RHC for mean pulmonary artery pressures was excellent with measurements confined within the equivalence bounds of −4.0 to 4.0 mmHg (mean PAP: 0.0 to 2.9 mmHg, P = 0.003). The device safety profile was excellent with 98.6% freedom from Device System Related Complications, defined as invasive treatment, device explant or death. There were no pressure sensor failures. Patients' adherence to daily measurement transmissions of PAP and vital signs was 94%. Conclusions This trial supports the safety and efficacy of the Cordella PA Sensor System and in conjunction with the CHFS enables comprehensive HF management in NYHA class III heart failure patients
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
Dispelling the Myths Behind First-author Citation Counts
Full text linkWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
koamabayili/VECTRON-author-checklist: VECTRON author checklist
No full textWe have done our best to complete the author checklist relating to the use of animals in the hut study. Note that the objective for the hut study was to evaluate the IRS treatment applications for residual efficacy against Anopheles mosquitoes, including the local An. coluzzii mosquito population. Cows were only used to attract mosquitoes into the huts and no tests were carried out directly on the cows. The author checklist is intended for use with studies where experiments are carried out on animals, which is why we have had such difficulty in completing this for the hut study, as many of the questions do not relate to how the cows were used
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