Ensite navx system

Manufactured by Abbott

Sourced in United States, Sao Tome and Principe

The EnSite NavX system is a cardiac mapping and navigation system used in electrophysiology procedures. It provides real-time 3D visualization of the patient's cardiac anatomy and electrical activity, allowing physicians to navigate catheters and locate areas of interest within the heart.

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Lab products found in correlation

Optima, by Abbott (2 mentions) Navistar thermocool, by Johnson & Johnson (2 mentions) Carto system, by Johnson & Johnson (2 mentions) Sensitherm, by Abbott (1 mentions) Coolflex, by Abbott (1 mentions) Reflexion hd, by Abbott (1 mentions) Carto 3, by Johnson & Johnson (1 mentions) Tacticath, by Abbott (1 mentions) Flexability, by Abbott (1 mentions) Agilis, by Abbott (1 mentions) Flexability catheter, by Abbott (1 mentions)

14 protocols using ensite navx system

Catheter Ablation Under Local Anesthesia

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EP study and ablation were done under local anesthesia after stoppage of antiarrhythmic drugs for at least 6 half-lives. Systemic anticoagulation was maintained by intravenous administration of heparin (initial bolus of 75 U/kg IV followed by 1000 U per hour) throughout the procedure.
Three Dimensional electro-anatomical mapping was done for all cases using either the CARTO 3 mapping system (Biosense, Diamond Bar, CA, USA) or the Ensite NavX® system (St Jude Medical, Inc, St Paul, MN) according to physician preference and availability. Three Dimensional compatible ablation catheters, (Thermocouple 4 mm tip 7F for Ensite NavX system and Thermocool 3.5 mm 8F for CARTO 3 system) were used. In addition a multi-electrode (quadripolar or decapolar) catheter was introduced into the RV (apex or RVOT) to be used for pacing and as a reference catheter if needed.

Badran H., Samir R, & Amin M. (2017). Outflow tract ventricular premature beats ablation in the presence or absence of structural heart disease: Technical considerations and clinical outcomes. The Egyptian Heart Journal, 69(4), 273-280.

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Catheter-Based Atrial Fibrillation Ablation

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A venous access site in the right internal jugular vein was used to introduce a duo‐decapolar catheter (Bee‐AT, Japan‐Lifeline Co., Ltd., Tokyo, Japan), of which the distal 10‐poles were positioned in the coronary sinus while the proximal 10‐poles were placed along the crista terminalis for internal cardioversion. After a double transseptal puncture, a 20‐pole circular mapping catheter (Optima™ or Reflexion HD™; St. Jude Medical, St. Paul, MN) and irrigated‐tip ablation catheter (Cool Flex™ or FlexAbility™; St. Jude Medical) were inserted into the LA for the mapping and ablation. A 3D geometry of the LA was created and fused with the pre‐operative 3DCT using an EnSite NavX™ system (St. Jude Medical). A temperature monitoring probe (SensiTherm™; St. Jude Medical) was inserted into the esophagus.

Kumagai K., Toyama H, & Zhang B. (2019). Effects of additional ablation of low‐voltage areas after Box isolation for persistent atrial fibrillation. Journal of Arrhythmia, 35(2), 197-204.

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Mapping and Ablation of Ventricular Tachycardia

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A 7-French deflectable, nonirrigated, quadripolar catheter with a 4-mm distal electrode, an embedded thermistor, and 2-5-2 mm interelectrode spacing (Cordis Webster Inc, Diamond Bar, CA, or EP Technologies Inc, San Jose, CA) was introduced retrogradely for mapping and ablation. If a 3-dimensional (3D) mapping system (Ensite NavX System; St Jude Medical Inc, St Paul, MN) was used, endocardial LV geometry was first created. Activation mapping during VT was performed, and specifically, sites with His or Purkinje potentials associated with local ventricular electrograms, extending from left basal septal sites with bundle of His recordings to most apical sites with presystolic Purkinje potentials (apical PP), were marked on the LV geometry (Figure 1). During cases where only conventional mapping was performed, sites with the earliest PP during VT were identified (Figure 2). Whenever possible, entrainment was performed to confirm participation of the targeted site in VT. If VT was not inducible, catheter ablation was not performed.

Liu Y., Fang Z., Yang B., Kojodjojo P., Chen H., Ju W., Cao K., Chen M, & Zhang F. (2015). Catheter Ablation of Fascicular Ventricular Tachycardia: Long-Term Clinical Outcomes and Mechanisms of Recurrence. Circulation. Arrhythmia and Electrophysiology, 8(6), 1443-1451.

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Radiofrequency Ablation Technique for Atrial Fibrillation

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For the MAN group, ablation was done by standard technique utilizing open irrigated ablation and mapping catheters (3.5 mm Navistar thermocool, Biosense-Webster Inc./Flexibility, St. Jude Medical Inc./Tacticath, St. Jude Medical Inc.) and multipolar deflectable catheters (Lasso, Biosense-Webster Inc. or Inquiry Optima Plus, St. Jude Medical Inc.). The two 3D electroanatomic mapping system used were the Carto3 (Biosense-Webster Inc.) as described above or the Ensite NavX system (St. Jude Medical Inc.). Briefly, the Ensite NavX system uses impedance measurements between individual catheter electrodes and external patches placed on the chest to project a 3D image of the catheters. Temperature control settings were similar to the remote magnetic navigation group.

Lim P.C., Toh J.J., Loh J.K., Lee E.C., Chong D.T., Tan B.Y., Ho K.L., Ching C.K, & Teo W.S. (2016). Remote magnetic catheter navigation versus conventional ablation in atrial fibrillation ablation: Fluoroscopy reduction. Journal of Arrhythmia, 33(3), 167-171.

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Detecting Left Atrial Scar via EAM

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Once SR was restored, EAM was performed using the EnsiteNavX System (St. Jude Medical) (5 (link),18 (link)). Bipolar signals between the distal electrode pair were recorded (filtered at 30 to 400 Hz) and displayed at 100 mm/s. Subsequently, peak-to-peak amplitude of the bipolar electrogram was measured automatically in the system. Of note, 95% of all bipolar electrogram signals recorded from the normal LA were >0.38 mV. Using the data generated from the control group, we defined normal endocardium using NavX contact mapping as a bipolar electrogram of >0.4 mV in our previous study. The point with voltage ≤0.4 mV was arbitrarily defined as the low voltage point. If the low voltage points coalesced and were contiguous to form a zone, we analyzed the distribution of the LVZ (7 (link),8 (link)). The scar group was defined as patients with an LVZ in the LA through EAM. Finally, a total of 101 patients were assigned to the non-scar (n=48, Figure 1A) and NPAF scar (with LVZs, n=53, Figure 1B) groups.

Qian L., Gong J., Ma W., Sun Y., Hong J., Xu D, & Chu M. (2021). Circulating S100A4 as a prognostic biomarker for patients with nonparoxysmal atrial fibrillation after catheter ablation. Annals of Translational Medicine, 9(18), 1400.

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Extensive Pulmonary Vein Isolation for Atrial Fibrillation

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Details of the AF ablation procedure used have been published elsewhere.17 Briefly, extensive encircling pulmonary vein isolation (EEPVI) was performed using a double‐lasso technique, with an open‐irrigated ablation catheter (Cool Flex/FlexAbility; St. Jude Medical, Inc, St. Paul, MN) and an electroanatomic integration mapping system (Ensite NavX System; St. Jude Medical, Inc). The endpoint criteria for EEPVI were the elimination of pulmonary vein potentials and the nonrecurrence of pulmonary vein spikes in all pulmonary veins after the intravenous administration of 20 to 40 mg of adenosine triphosphate during sinus rhythm or coronary sinus. In patients with paroxysmal AF, only EEPVI was performed. In patients with persistent and longstanding persistent AF, additional ablation was combined with EEPVI at the operator's discretion. Additional ablation included left atrial linear ablation, left atrial low‐voltage area ablation, and ablation of complex fractionated atrial electrograms in the right and left atrium.

Yamaji H., Murakami T., Hina K., Higashiya S., Kawamura H., Murakami M., Kamikawa S., Hirohata S, & Kusachi S. (2019). Activated clotting time on the day of atrial fibrillation ablation for minimally interrupted and uninterrupted direct oral anticoagulation therapy: Sequential changes, differences among direct oral anticoagulants, and ablation safety outcomes. Journal of Cardiovascular Electrophysiology, 30(12), 2823-2833.

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Pulmonary Vein Isolation with Circumferential Ablation

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Pulmonary vein isolation (PVI) was performed using one 7-F decapolar circular catheter (Optima; St. Jude Medical, Inc.) positioned at the ostia of ipsilateral PVs; 3D-CT reconstruction was integrated into an electro-anatomical mapping system (EnSite NavX system, St. Jude Medical, Inc.). We created bilateral circular lesions with wide-area circumferential ablation encircling the ipsilateral PV; each application of RF energy was delivered for 30–60 by using a 3.5-mm irrigated tip RF catheter (FlexAbility; St. Jude Medical, Inc.), with the temperature limited to 42℃, power output at 25–35 W, and a flow rate of 13 mL/min. Biphasic direct current cardioversion restored the SR if AF did not terminate spontaneously after successful PVI. The endpoint of PVI was the creation of a bidirectional conduction block between LA and PVs
²⁰⁾. At the end of the procedure, all PVs were successfully isolated.

Nakamura K., Takagi T., Kogame N., Hashimoto H., Asami M., Toyoda Y., Enomoto Y., Hara H., Noro M., Sugi K., Moroi M, & Nakamura M. (2020). The Association of Cardio-Ankle Vascular Index (CAVI) with Biatrial Remodeling in Atrial Fibrillation. Journal of Atherosclerosis and Thrombosis, 28(6), 590-603.

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Left Atrial Voltage Mapping for AF

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LA substrate remodeling was mainly evaluated by the extent of the low-voltage zone in the LA [16] . In 30 patients with AF, the threedimensional geometry of the left atrium was described with the EnSite NavX system version 6.0J (St Jude Medical, St. Paul, MN, USA). A three-dimensional voltage map was constructed during sinus rhythm before the PV isolation, in a point-by-point recording fashion, using contact bipolar electrograms obtained from throughout the endocardial left atrium. Global contact bipolar mapping points were collected using an interpolation of 10 mm. The surface area of each left atrium was calculated using a research segmentation software package. Patients presenting with AF at the time of PV isolation were excluded. The LA voltage zone index was calculated as the LA area with voltage <0.5 mV divided by the total LA surface area.

Soeki T., Matsuura T., Bando S., Tobiume T., Uematsu E., Ise T., Kusunose K., Yamaguchi K., Yagi S., Fukuda D., Yamada H., Wakatsuki T., Shimabukuro M, & Sata M. (2016). Relationship between local production of microRNA-328 and atrial substrate remodeling in atrial fibrillation. Journal of cardiology, 68(6).

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Epicardial Substrate Mapping and Ablation

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The procedure was performed under conscious sedation. A tetrapolar diagnostic catheter was positioned at the right ventricular (RV) apex. A 3.5-mm-tip open-irrigated ablation catheter (ThermoCool, NaviStar, Biosense Webster, Inc., Diamond Bar, CA) was used for mapping and ablation. A steerable sheath (Agilis, St. Jude Medical, Inc., St. Paul, MN) facilitated mapping through a transseptal access. A temperature control of 45ºC, a power limit of 50 W, and an irrigation rate of 26-30 mL/min were used (40 W and 17 mL/min at the epicardium). The transseptal approach was used (except in ARVD) for left ventricular (LV) endocardial mapping (BRK needle, Medtronic, Inc., Minneapolis, MN). After transseptal access, heparin was administered intravenously to maintain an activated clotting time of 4300 seconds. The CARTO system (Biosense Webster, Inc.) or the EnSite NavX system (St. Jude Medical, Inc.) was used for substrate mapping. Epicardial mapping criteria were as follows: (1) underlying disease with a high probability of having epicardial substrate (ARVD or Chagas disease), (2) epicardial hyperenhancement on ce-CMR, (3) endocardial mapping not identifying endocardial scar, (4) electrocardiogram of clinical or induced VT, suggesting an epicardial origin, and (5) after previous endocardial ablation failure.

Fernández-Armenta J., Penela D., Acosta J., Andreu D., Evertz R., Cabrera M., Korshunov V., Vassanelli F., Martínez M., Guasch E., Arbelo E., María Tolosana J., Mont L, & Berruezo A. (2016). Substrate modification or ventricular tachycardia induction, mapping, and ablation as the first step? A randomized study. Heart rhythm, 13(8).

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Electroanatomical Mapping and CT Fusion

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Merging of the electroanatomical mapping with the CT images was conducted by four consecutive steps: geometry, trimming, field scaling, and alignment steps. To acquire the clinical LA voltage map and local activation map, a clinical electroanatomical map merged with the CT image was obtained during the clinical ablation procedure in each patient. Using an Ensite NavX system (Abbott Inc., Lake Bluff, Illinois, USA), we obtained the clinical LA voltage data during sinus rhythm based on the bipolar electrograms recorded from about 500 points on the LA during the AFCA. Using the method embedded in the Ensite NavX system, the technician coordinated the 3D LA modeling results with the clinical map after merging it with the cardiac CT images of the patient. Furthermore, we also stored the LA voltage data from each clinical catheter point during the procedure.

Park J.W., Lim B., Hwang I., Kwon O.S., Yu H.T., Kim T.H., Uhm J.S., Joung B., Lee M.H, & Pak H.N. (2022). Restitution Slope Affects the Outcome of Dominant Frequency Ablation in Persistent Atrial Fibrillation: CUVIA-AF2 Post-Hoc Analysis Based on Computational Modeling Study. Frontiers in Cardiovascular Medicine, 9, 838646.

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