Bates Alexander, Naseer Mohammad, Taylor Mark, Denham Nathan, Yue Arthur, Das Moloy, Morris Gwilym M, Ullah Waqas
University Hospital Southampton NHS Foundation Trust, Southampton, UK.
School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
J Innov Card Rhythm Manag. 2023 May 15;14(5):5442-5450. doi: 10.19102/icrm.2023.14054. eCollection 2023 May.
The learning curve for the novel RHYTHMIA HDx™ 3-dimensional electroanatomic system is unknown. Retrospective data collection was carried out at 3 U.K. centers from the introduction of RHYTHMIA HDx™ (Boston Scientific, Marlborough, MA, USA) and associated mapping and ablation catheters. Patients were matched with controls using the CARTO 3 mapping system (Biosense Webster Inc., Diamond Bar, CA, USA). Fluoroscopy, radiofrequency ablation, and procedure times; acute and long-term success; and complications were assessed. A total of 253 study patients along with 253 controls were included. Significant correlations existed between procedural efficiency metrics and center experience for de novo atrial fibrillation (AF) ablation (procedure time, Spearman's ρ = -0.624; ablation time, ρ = -0.795; both < .0005) and de novo atrial flutter (AFL) ablation (ablation time, ρ = -0.566; fluoroscopy time, ρ = -0.520; both = .001). No correlations existed for other assessed atrial arrhythmias. For de novo AF and AFL, metrics significantly improved after 10 procedures in each center (procedure time [AF only, = .001], ablation time [AF, < .0005; AFL, < .0005], and fluoroscopy time [AFL only, = .0022]) and became comparable to those of controls. Acute success and long-term success did not experience significant improvements with experience, but they were comparable to the control group throughout. Complications with RHYTHMIA HDx™ were comparable to those associated with CARTO 3. In conclusion, a short learning curve exists with the use of RHYTHMIA HDx™ for standardized procedures (de novo AF/AFL). Procedural performance improved and became comparable to that seen with CARTO 3 following 10 cases at each center. Clinical outcomes at 6 and 12 months and complications were no different from those observed in controls.
新型RHYTHMIA HDx™三维电解剖系统的学习曲线尚不清楚。在英国的3个中心进行了回顾性数据收集，数据来自RHYTHMIA HDx™（美国波士顿科学公司，马尔伯勒，马萨诸塞州）及相关标测和消融导管引入之后。使用CARTO 3标测系统（美国加利福尼亚州钻石吧市Biosense Webster公司）将患者与对照组进行匹配。评估了透视时间、射频消融时间和手术时间；急性和长期成功率；以及并发症情况。共纳入253例研究患者和253例对照。对于初发性心房颤动（AF）消融（手术时间，Spearman秩相关系数ρ = -０.624；消融时间，ρ = -０.795；均P < 0.0005）和初发性心房扑动（AFL）消融（消融时间，ρ = -０.566；透视时间，ρ = -０.520；均P = 0.001），手术效率指标与中心经验之间存在显著相关性。对于其他评估的房性心律失常则不存在相关性。对于初发性AF和AFL，每个中心在完成10例手术后，各项指标有显著改善（手术时间[仅AF，P = 0.001]、消融时间[AF，P < 0.0005；AFL，P < 0.0005]和透视时间[仅AFL，P = 0.0022]），并与对照组相当。急性成功率和长期成功率并未随经验的增加而显著提高，但总体上与对照组相当。RHYTHMIA HDx™相关的并发症与CARTO 3相关的并发症相当。总之，使用RHYTHMIA HDx™进行标准化手术（初发性AF/AFL）时学习曲线较短。每个中心完成10例手术后手术表现得到改善，并与CARTO 3相当。6个月和12个月时的临床结局及并发症与对照组观察到的情况无差异。
