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Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results
No full textAims The multicentre, single-arm SmartfIRE study assessed the safety and effectiveness of the novel dual-energy THERMOCOOL SMARTTOUCH SF (DE STSF) contact-force sensing catheter with multimodality generator to deliver radiofrequency (RF) and unipolar biphasic pulsed field (PF) ablation. Three-month follow-up showed a 100% acute success rate with an acceptable safety profile. Results at 12 months postablation are summarized here.Methods and results Patients with symptomatic paroxysmal atrial fibrillation underwent pulmonary vein isolation with the recommendation of PF ablation at posterior/inferior and RF ablation at the anterior/ridge/carina segments. The 12-month effectiveness endpoint was freedom from documented symptomatic and asymptomatic atrial arrhythmia on or off antiarrhythmic therapy (assessed by electrocardiogram, remote arrhythmia monitoring, and 24-h Holter), including acute procedural failures. Safety was assessed as the incidence of serious adverse events (SAEs) related to device and/or procedure. Quality of life was evaluated via Atrial Fibrillation Effect on Quality-of-Life (AFEQT) scores, and healthcare utilization was assessed as hospitalization for cardiovascular events and antiarrhythmic drug (AAD) use. Of 149 patients enrolled, 140 had the study catheter inserted (safety population analysis set), and 136 met the eligibility criteria and had ablation energy delivered (per-protocol analysis set). Freedom from symptomatic and asymptomatic atrial arrhythmia at 12 months was 71.5% (84.2% when using standard-of-care monitoring only). The clinical success rate (freedom from symptomatic arrhythmia) was 86.4%, and single procedural success was 81.0% (n = 136). The rate of device- and/or procedure-related SAEs was 3.6% (5/140 patients; two cardiac tamponades, two pulmonary vein stenosis, one anaphylactic shock). At 12 months, the overall AFEQT score increased by a median 26.9 points vs. baseline. Cardiovascular hospitalization rate reduced from 20.1 to 11.9% during the 12 months before vs. after ablation, respectively. The use of Class I/III AAD decreased from 60.3% at baseline to 23.9% at 6-12 months postablation. Post hoc analysis showed that patients with high adherence to recommended inter-tag distance and PF/RF index during ablation (n = 47) had a 12-month freedom from atrial arrhythmia recurrence of 86.9%, while the remaining patients (n = 88) had a rate of 64.0%.Conclusion The 12-month follow-up of the SmartfIRE study demonstrated the effectiveness, safety, and healthcare benefits of ablation using the DE STSF platform.Clinical Trial Registration ClinicalTrials.gov Identifier: NCT05752487 (https://clinicaltrials.gov/study/NCT05752487)Clinical Trial Registration ClinicalTrials.gov Identifier: NCT05752487 (https://clinicaltrials.gov/study/NCT05752487)Funding
This study was supported by Biosense Webster, Inc., part of Johnson & Johnson MedTech.
Acknowledgements
We thank all SmartfIRE study personnel and patients for their valuable participation in this trial. We thank the following individuals for their efforts in trial execution, statistical analysis, and input during the development of this
article: Sarah Rabau, Liesbeth Vanderlinden, Li Wan, Jennifer Maffre, Guixia Huang, Farid Jamshidian, Yanmin Wang, Erin Rogers, and Swati Trivedi. Medical writing and editorial assistance was provided in accordance with
Good Publication Practice guidelines by Michelle Hughes, PhD, of Lumanity Communications, Inc. (Yardley, PA, USA), under the guidance of the authors, and was funded by Biosense Webster, Inc. (Irvine, CA, USA), part of Johnson & Johnson MedTech
Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results /
No full textAims: Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-Ablation are presented here. Methods and results: Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-Tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-Tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated. Conclusion: A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability. Clinical trial registration: ClinicalTrials.gov Identifier: NCT05752487
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe 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
Get PDF“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
Get PDFWe 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
Get PDFWe 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
Author-wise bibliometric analysis based on entropy.
No full textAuthor-wise bibliometric analysis based on entropy.</p
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