University of California San Diego, 4952 Medical Center Dr, ACTRI Bldg, 3rd Floor, Room 3E-313, MC7411, La Jolla, CA, 92037, USA.
University of Toronto, Toronto, Canada.
J Interv Card Electrophysiol. 2022 Oct;65(1):141-151. doi: 10.1007/s10840-022-01239-4. Epub 2022 May 10.
The EnSite Precision™ cardiac mapping system (Abbott) 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 3D maps of cardiac chambers. The EnSite Precision™ Observational Study (NCT-03260244) 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 evaluate procedural outcomes.
A total of 1065 patients were enrolled at 38 centers in the USA and Canada between 2017 and 2018 and were followed for 12 months post procedure for arrhythmia recurrence, medication use, and quality-of-life changes. Eligible subjects were adults undergoing a cardiac electrophysiology mapping and radiofrequency ablation procedure using the EnSite Precision™ System.
A final cohort of 925 patients (64.3 years of age, 30.2% female) were analyzed. The primary procedural indication was atrial flutter in 48.1% (445/925), atrial fibrillation in 46.5% (430/925), and other arrhythmias in 5% (50/925). Electroanatomic mapping was performed in 81.5% (754/925) of patients. Mapping was stable throughout 79.8% (738/925) of procedures with initial mapping time of 8.6 min (IQR 4.7-15.0). Average mapping efficiency created with AutoMap or TurboMap was 164.9 ± 365.7 used points per minute. Median number of mapping points collected and used was 1752.5 and 811.0, respectively. Only 335/925 (36.2%) required editing and 66.0% (221/335) of these patients required editing of less than 10 points. Fluoroscopy was utilized in most cases (n = 811/925, 87.4%) with fluoroscopy time of 11.0 min (IQR 6.0-18.0). Overall median procedure time was 101.0 min (IQR 59.0-152.0). Acute procedural success was high for both atrial fibrillation (n = 422/430, 98.1%) and atrial flutter (n = 434/445, 97.5%).
In a real-world study analysis, use of the EnSite Precision™ mapping system was associated with high procedural stability, short mapping times, high point density requiring infrequent editing, low fluoroscopy time, and high prevalence of acute procedural success.
EnSite Precision™ 心脏标测系统（雅培）是一种导管导航和标测系统，能够显示常规和带传感器的电生理导管的三维（3D）位置，并显示心脏电活动作为波形轨迹和心脏腔室的动态 3D 图。EnSite Precision™ 观察性研究（NCT-03260244）旨在量化和描述 EnSite Precision™ 心脏标测系统在真实环境中用于心脏心律失常标测和消融的使用情况，并评估手术结果。
2017 年至 2018 年期间，在美国和加拿大的 38 个中心共招募了 1065 名患者，术后 12 个月对心律失常复发、药物使用和生活质量变化进行随访。符合条件的受试者为接受 EnSite Precision™ 系统进行心脏电生理标测和射频消融手术的成年人。
对 925 名患者（64.3 岁，30.2%为女性）进行了最终队列分析。主要手术指征为心房扑动 48.1%（445/925）、心房颤动 46.5%（430/925）和其他心律失常 5%（50/925）。81.5%（754/925）的患者进行了电解剖标测。79.8%（738/925）的手术过程中保持稳定的标测，初始标测时间为 8.6 分钟（IQR 4.7-15.0）。使用 AutoMap 或 TurboMap 平均每分钟创建 164.9±365.7 个有效标测点。收集和使用的中位数标测点数分别为 1752.5 和 811.0。仅 335/925（36.2%）需要编辑，其中 66.0%（221/335）的患者需要编辑少于 10 个点。大多数情况下都使用了透视（n=811/925，87.4%），透视时间为 11.0 分钟（IQR 6.0-18.0）。总体中位数手术时间为 101.0 分钟（IQR 59.0-152.0）。心房颤动（n=422/430，98.1%）和心房扑动（n=434/445，97.5%）的急性手术成功率均较高。
在真实世界的研究分析中，使用 EnSite Precision™ 标测系统与较高的手术稳定性、较短的标测时间、高密度的标测点、较少需要编辑、透视时间短以及较高的急性手术成功率相关。
