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Ensite

Manufactured by Abbott
Sourced in United States

The EnSite is a medical device that is used to assist with cardiac electrophysiology procedures. It provides advanced mapping and visualization capabilities to help healthcare professionals assess cardiac electrical activity and guide treatment decisions.

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12 protocols using ensite

1

Comparing Ablation Techniques for Atrioventricular Nodal Reentrant Tachycardia

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All patients underwent electrophysiologic (EP) testing in the fasting state after providing written informed consent for the procedure. EP testing was performed with catheters positioned in the right atrium, His bundle territory, the coronary sinus, and the right ventricle. Both programmed stimulation and burst pacing were performed in an effort to induce AVNRT. Dual AV nodal physiology was defined as a ≥50 ms increase in the AH or HA interval during programmed stimulation from the atrium or ventricle, respectively. Once tachycardia was induced, the diagnosis of AVNRT was made according to commonly accepted criteria.14 (link) A three-dimensional (3-D) mapping with either the Carto™ (Biosense Webster; Diamond Bar, CA, USA) or Ensite™ (St Jude Medical; Minneapolis, MN, USA) mapping systems were used in all cases. Patients then underwent catheter ablation of the SP of the AV nodal complex using one of the three different ablation modalities: manual RF energy, RMN-guided RF ablation, and CYRO. These three groups were then compared as defined in the following section.
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2

Catheter Ablation for Accessory Pathways

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All catheter ablation procedures were performed under general anesthesia using standard techniques, equipment, and electroanatomic mapping (EnSite, St. Jude Medical, Inc., St. Paul, MN, USA). All patients had a surface ECG recorded followed by vascular access. After vascular access was obtained, catheters were placed near the His Bundle, right atrial appendage, right ventricular apex, and coronary sinus. Pacing protocols were performed with rapid atrial pacing from the high right atrium, atrial and ventricular extrastimulus testing at baseline and on isoproterenol. For left-sided APs, access was obtained via trans-septal puncture. Ablation was performed with radiofrequency or cryoablation technique. AP location was determined by the site of successful ablation.
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3

Pulmonary Vein Isolation Protocol

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All procedures were performed in patients under conscious sedation. A decapolar catheter was introduced into the coronary sinus and two transseptal accesses were obtained through the right femoral vein. A single heparin bolus of 100 IU/kg was administered following transseptal puncture. During the procedure, the activated clotting time (ACT) was maintained from 250 to 300 s. The CARTO (Biosense Webster) or EnSite (St. Jude Medical) 3‐dimensional electroanatomic mapping systems were used for mapping cardiac reconstruction and guiding ablation. All patients underwent standard pulmonary vein isolation (PVI) and additional liner ablation was performed according to the physician's discretion. The endpoint of ablation was left and right‐sided pulmonary vein electrical isolation and restoring sinus rhythm by either ablation or electric cardioversion. The CA procedure time was determined from the femoral venous puncture to the end of the ablation.
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4

Catheter-Based Ablation for Atrial Fibrillation

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Under conscious sedation, a decapolar catheter was positioned in the coronary sinus, and two transseptal accesses were obtained through the right femoral vein. Mapping and ablation were performed under the guidance of CARTO (Biosense Webster, Diamond Bar, CA, USA) or EnSite (St. Jude Medical, St Paul, MN, USA) 3-dimensional electroanatomic mapping systems in addition to standard fluoroscopy. For patients with paroxysmal AF, standard pulmonary vein isolation (PVI) was performed, and for those with persistent AF, additional linear and/or complex fragmented atrial electrogram (CFAE) ablations were performed according to the physician's discretion. Sinus rhythm was restored by either ablation or electric cardioversion.
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5

Ablation Procedures for Atrial Fibrillation

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The indications for performed AF ablation procedures were in accordance with the current guidelines. 15 (link) Paroxysmal AF was defined as self-terminating AF, whereas persistent AF was defined as AF lasting longer than 7 days. 15 (link) Intravenous fentanyl, midazolam, and propofol were used in all cases for conscious sedation. Femoral venous access was used for all procedures. Transseptal puncture was performed under fluoroscopy positioning and pressure monitoring. Intracardiac echocardiography was used for visualization of the interatrial septum in case of difficulty in performing safe transseptal puncture. An electroanatomical mapping system (CARTO, Biosense Webster, Inc, Diamond Bar, CA or ENSITE, St. Jude Medical, Inc, MN) and left atrial fast anatomic map was merged with the cardiac CT images to guide ablation. Temperature-controlled ablation was performed with an irrigated 4 mm tip catheter, with an standard target power delivery of 25 to 35 W in the majority of cases. Pulmonary vein isolation was the goal of each initial procedure.
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6

Automated Radiofrequency Ablation Metrics

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PVI was performed with the AutoMark system (EnSite; Abbott). The FTI and LSI were calculated only when the ablation catheter stayed within the confined area. FTI was defined as the total CF integrated over the time of RF delivery, and the LSI was derived from a mathematical expression that incorporates CF, power and duration of RF application. AutoMark settings for filter thresholds were as follows: for catheter position stability, the minimum marker time was 4 seconds, the marker spacing was 4 mm, and the away time was 5 seconds.
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7

Conventional Catheter Ablation for Atrial Fibrillation

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In all patients in the conventional arm, a 3D mapping system (CARTO3, Biosense Webster, Irvine, CA, USA and EnSite, Abbott, Abbott Park, IL, USA) was used to obtain LA anatomy and scar. Conventional CA was performed using RF energy applied by a contact-force catheter (Thermocool Smarttouch, Biosense Webster, Irvine, CA, USA and TactiCath, Abbott, Abbott Park, IL, USA) with a maximum power delivery of 40 W. High-power short-duration ablation (70 W) was performed in two patients. The ablation extent was at the operator’s discretion and was determined by low-voltage areas (<0.5 mV) and scar tissue (<0.2 mV) identified by the electroanatomical 3D map.
Two strategies were pursued: defragmentation of complex fractionated atrial electrograms (CFAE) (visually identified by the operator based on previously published criteria [21 (link)]) and/or anatomical linear ablations in the LA, including roof line, anterior line, mitral isthmus line and posterior wall isolation (PWI). The procedural endpoint was the non-excitability of the ablation sites and, in the case of linear ablations, the proof of bidirectional block using differential pacing and obtaining a propagation map during LAA pacing.
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8

Cardiac Ablation Under Conscious Sedation

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All procedures were performed under mild-to-moderate conscious sedation using dexmedetomidine, fentanyl, and thiopental. All patients had continuous arterial blood pressure monitored with an arterial line and received oxygen (5 L/min) either with a face mask or noninvasive positive-pressure ventilation in case of sleep apnea syndrome. Our usual practice has been to skip anticoagulation on the morning of CA, except for patients on warfarin or patients on direct oral anticoagulant with a history of stroke or low left atrial appendage blood flow velocity. Unfractionated heparin was administered during the left heart CA to maintain the activated clotting time (ACT) of ≥300 seconds. Diagnostic catheters were introduced via femoral and internal jugular veins and positioned at the coronary sinus (CS), tricuspid annulus, His recording site, and right ventricle (RV) apex according to the physician’s decision. A 3-dimensional electroanatomic mapping system was created using CARTO (Biosense Webster, Diamond Bar, CA), Ensite (Abbott Laboratories, Chicago, IL), or Rhythmia (Boston Scientific, Cambridge, MA), except in patients who were ablated using the cryoballoon system. As per our safety protocol, we used intracardiac echocardiography (ICE) just for the transseptal puncture and usually remove it prior to the insertion of the ablation catheter to minimize venous access.
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9

Cardiac Mapping and Ablation Procedures

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The procedures were mostly performed under conscious sedation, but were under general anesthesia in 7 cases. Transvenous multipolar catheters were placed into the cardiac chambers appropriate for the arrhythmia being studied (right and/or left ventricular [RV and/or LV]). LV mapping was performed via the retrograde aortic or transseptal approach. When necessary, an epicardial approach using a percutaneous subxiphoid puncture was attempted at the beginning of the procedure as previously described.12 Electroanatomic mapping systems such as CARTO3 (Biosense Webster) or Ensite (Abbott) were used. Intracardiac echocardiography assisted in defining the anatomical structures, monitoring for potential complications, and performing transseptal punctures. Systemic anticoagulation was achieved with intravenous heparin targeting a minimum activation clotting time of 350 s during LV and 250 s during RV mapping. The RF current was delivered with a 3.5‐mm open irrigated tip catheter, with power settings of 30–50 W and temperature limit of 43°C. Contact force sensing catheters were used by the operators while aiming for a 5–30 g contact force.
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10

Comprehensive Approach to Cardiac Arrhythmia Ablation

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Clinical electrophysiology studies were performed using standard equipment and electroanatomic mapping (CARTO, Biosense Webster or EnSite, Abbott Medical Inc.). After obtaining vascular access, multi-electrode catheters were positioned under direct fluoroscopy. A surface ECG was recorded prior to ablation. The average procedure time in this cohort was 147±60 minutes with an average fluoroscopy time of 20.0 ± 14.1 minutes. Entrainment maneuvers, activation sequence mapping and 3D electroanatomical mapping were performed for patients presenting with AFL, AT, or a conducting AP participating in a clinical arrhythmia. For patients presenting for PVC or WPW ablation with manifest ventricular pre-excitation, the ablation site was determined by the earliest activation during electroanatomic mapping either in sinus or ventricularly paced rhythm. Electrophysiology study and ablation reports for the 55 included patients and 12-lead ECGs available for 52 patients are presented in the Supplemental Material.
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