Clinical and regulatory considerations for novel electrophysiology mapping systems: Lessons from FIRM

2018 ◽  
Vol 41 (12) ◽  
pp. 1669-1680 ◽  
Author(s):  
Daniel Wann ◽  
Jonathan W. Waks ◽  
Daniel B. Kramer
Author(s):  
Nicholas D. Skadsberg ◽  
Timothy G. Laske ◽  
Paul A. Iaizzo

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Lin ◽  
B Glover ◽  
J Colley ◽  
B Thibault ◽  
C.M Steinberg ◽  
...  

Abstract Background The EnSite Precision™ Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional and sensor enabled electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and dynamic 3-D maps of cardiac chambers. Objective The EnSite Precision™ Observational Study was designed to quantify and characterize the use of the EnSite Precision™ Cardiac Mapping System for mapping and ablation of cardiac arrhythmias in a real-world environment and to evaluate procedural and subsequent clinical outcomes. Methods 1065 patients were enrolled at 38 centers in the U.S. and Canada between 2017–2018. Eligible subjects were adults undergoing a cardiac electrophysiology mapping and radiofrequency ablation procedures using the EnSite Precision™ System. Results Of 989 patients who completed the protocol, a geometry was created in 936 (94.7%). Most initial maps were created using Automap (n=545, 67.0%) or a combination of Automap and manually mapping (n=151, 18.6%). Median time to create an initial map was 9.0 min (IQR 5.0–15.0), with a median number of used mapping points per minute of 92.7 (IQR 30.0–192.0). During ablation, AutoMark was used in 817 (82.6%) of procedures. The most frequent metrics for lesion color were Impedance Drop or Impedance Drop Percent (45.5% combined), time (23.9%) and average force (14.2%). At Canadian sites where LSI was an option, it was used as the color metric in 87 (45.8%) of cases (10.6% overall). The EnSite System was stable throughout 79.7% (n=788 of 989) of procedures. Factors affecting stability were respiratory change (n=88 of 989, 8.9%), patient movement (n=73, 7.4%), CS Positional Reference dislodgement (n=32, 3.2%), and cardioversion (n=19, 1.9%). Conscious sedation was used in 189 (19.1%) of patients. Acute success was reached based on the pre-defined endpoints for the procedure in 97.4% (n=963) of cases. Conclusion In a real-world study analysis, the EnSite Precision™ mapping system was associated with a high prevalence of acute procedural success, low mapping times, and high system stability. Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 13 (13) ◽  
pp. 2485
Author(s):  
Yi-Chun Lin ◽  
Raja Manish ◽  
Darcy Bullock ◽  
Ayman Habib

Maintenance of roadside ditches is important to avoid localized flooding and premature failure of pavements. Scheduling effective preventative maintenance requires a reasonably detailed mapping of the ditch profile to identify areas in need of excavation to remove long-term sediment accumulation. This study utilizes high-resolution, high-quality point clouds collected by mobile LiDAR mapping systems (MLMS) for mapping roadside ditches and performing hydrological analyses. The performance of alternative MLMS units, including an unmanned aerial vehicle, an unmanned ground vehicle, a portable backpack system along with its vehicle-mounted version, a medium-grade wheel-based system, and a high-grade wheel-based system, is evaluated. Point clouds from all the MLMS units are in agreement within the ±3 cm range for solid surfaces and ±7 cm range for vegetated areas along the vertical direction. The portable backpack system that could be carried by a surveyor or mounted on a vehicle is found to be the most cost-effective method for mapping roadside ditches, followed by the medium-grade wheel-based system. Furthermore, a framework for ditch line characterization is proposed and tested using datasets acquired by the medium-grade wheel-based and vehicle-mounted portable systems over a state highway. An existing ground-filtering approach—cloth simulation—is modified to handle variations in point density of mobile LiDAR data. Hydrological analyses, including flow direction and flow accumulation, are applied to extract the drainage network from the digital terrain model (DTM). Cross-sectional/longitudinal profiles of the ditch are automatically extracted from the LiDAR data and visualized in 3D point clouds and 2D images. The slope derived from the LiDAR data turned out to be very close to the highway cross slope design standards of 2% on driving lanes, 4% on shoulders, and a 6-by-1 slope for ditch lines.


2021 ◽  
Vol 23 (4) ◽  
Author(s):  
Christopher S. Purtell ◽  
Ryan T. Kipp ◽  
Lee L. Eckhardt

Abstract Purpose of Review There are risks to both patients and electrophysiology providers from radiation exposure from fluoroscopic imaging, and there is increased interest in fluoroscopic reduction. We review the imaging tools, their applications, and current uses to eliminate fluoroscopy. Recent Findings Multiple recent studies provide supporting evidence for the transition to fluoroscopy-free techniques for both ablations and device implantation. The most frequently used alternative imaging approaches include intracardiac echocardiography, cardiac MRI guidance, and 3D electroanatomic mapping systems. Electroanatomic mapping and intracardiac echocardiography originally used to augment fluoroscopy imaging are now replacing the older imaging technique. The data supports that the future of electrophysiology can be fluoroscopy-free or very low fluoroscopy for the vast majority of cases. Summary As provider and institution experience grows with these techniques, many EP labs may choose to completely forego the use of fluoroscopy. Trainees will benefit from early experience with these techniques.


2013 ◽  
Vol 7 ◽  
pp. CMC.S11501 ◽  
Author(s):  
Mazen T. Ghanem ◽  
Rania S. Ahmed ◽  
Ayman M. Abd El Moteleb ◽  
John K. Zarif

During ablation of re-entrant ventricular tachycardia (VT) 3-dimensional mapping systems are now used to properly delineate the scar tissue and aid ablation of scar-related VT. The aim of our study was to outline how the mode of ablation predicts success and recurrence in large scar-related VT. When comparing patients with recurrence and patients with no recurrence, univariate analysis showed that number of ablation lesions (28 ± 8 vs. 12 ± 8, P = 0.01) and more linear ablation lesions rather than focal lesions ( P = 0.03) were associated with long-term success. We demonstrated that more extensive ablation lesions and creation of linear lesions is associated with better success rate and lower recurrence rate during ablation of large scar-related ventricular tachycardia.


2018 ◽  
Vol 215 (12) ◽  
pp. 2994-3005 ◽  
Author(s):  
Rebecca Gentek ◽  
Clément Ghigo ◽  
Guillaume Hoeffel ◽  
Audrey Jorquera ◽  
Rasha Msallam ◽  
...  

The murine epidermis harbors two immune cell lineages, Langerhans cells (LCs) and γδ T cells known as dendritic epidermal T cells (DETCs). LCs develop from both early yolk sac (YS) progenitors and fetal liver monocytes before locally self-renewing in the adult. For DETCs, the mechanisms of homeostatic maintenance and their hematopoietic origin are largely unknown. Here, we exploited multicolor fate mapping systems to reveal that DETCs slowly turn over at steady state. Like for LCs, homeostatic maintenance of DETCs is achieved by clonal expansion of tissue-resident cells assembled in proliferative units. The same mechanism, albeit accelerated, facilitates DETC replenishment upon injury. Hematopoietic lineage tracing uncovered that DETCs are established independently of definitive hematopoietic stem cells and instead originate from YS hematopoiesis, again reminiscent of LCs. DETCs thus resemble LCs concerning their maintenance, replenishment mechanisms, and hematopoietic development, suggesting that the epidermal microenvironment exerts a lineage-independent influence on the initial seeding and homeostatic maintenance of its resident immune cells.


2018 ◽  
Vol 8 (3) ◽  
pp. 416 ◽  
Author(s):  
Andrea Masiero ◽  
Francesca Fissore ◽  
Alberto Guarnieri ◽  
Francesco Pirotti ◽  
Domenico Visintini ◽  
...  

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