Sensei机器人导航系统在心房颤动导管消融中有效性及安全性的meta分析

熊青松; 何贵均; 殷跃辉; 上官娇玲; 凌智瑜

doi:10.13201/j.issn.1001-1439.2019.03.009

Sensei机器人导航系统在心房颤动导管消融中有效性及安全性的meta分析

- 重庆医科大学附属第二医院心内科(重庆, 400010)

详细信息

通讯作者: 凌智瑜,E-mail:lingzy1977@163.com

中图分类号: R541.7

收稿日期: 2018-12-17

Meta-analysis of the effectiveness and safety of Sensei robot navigation system in atrial fibrillation catheter ablation

- The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400010, China

More Information

Corresponding author: LING Zhiyu, E-mail: lingzy1977@163.com

Received Date: 17 December 2018

摘要

摘要: 目的：比较Sensei机器人导航系统（robotic navigation system）与传统手动引导进行心房颤动（房颤）导管消融的有效性、安全性及在降低放射暴露中的效应。方法：通过计算机检索Pubmed、Embase、Cochrane数据库中比较Sensei机器人导航和手动引导进行房颤消融的文章，包括随机对照试验（RCT）及非随机对照试验。主要结局为Sensei机器人导航和手动引导进行手术的随访成功率、手术时间、放射暴露时间、放射剂量，次要结局为手术的主要并发症及轻微并发症的发生率。结果：研究共纳入11篇相关文献，包含3760例患者（5篇RCT及6篇队列研究）。汇总分析表明，sensei机器人导航与传统手动引导手术的成功率比较差异无统计学意义（OR=1.21，95%CI：0.78~1.86，P=0.16；MD=5.00，95%CI：-10.64~20.64，P<0.00001），RCT结果显示机器人导航的手术时间更长且差异有统计学意义（MD=30.00，95%CI：21.65~38.35），放射时间（MD=-8.37，95%CI：-11.37~-5.37，P<0.0001）及放射剂量（SMD=-0.73，95%CI：-1.19~-0.26，P=0.002）均减少，手术主要并发症（OR=1.11，95%CI：0.75~1.64，P=0.62）及轻微并发症（OR=1.02，95%CI：0.41~2.52）无明显统计学意义。结论：Sensei机器人导航系统与传统手动引导比较可明显减少放射暴露及放射时间，手术时间、有效性及安全性无明显差异。
- 心房颤动 /
- 机器人导航 /
- 导管消融 /
- meta分析
Abstract: Objective: To compare the effectiveness, safety, and effects of Sensei robotic navigation systems versus conventional manual navigation for atrial fibrillation catheter ablation.Method: A literature review of Sensei robotic navigation and manual guidance for atrial fibrillation in the pubmed, embase, and cochrane databases was performed by computer, including randomized controlled trials (RCT) and non-randomized controlled trials.The primary outcome was Sensei robotic navigation and manual guidance for follow-up success rate, operative time, radiation exposure time, and radiation dose.Secondary outcomes were the primary complication rate and minor complication rate.Result: A total of 11 related articles were included in the study, including a total of 3, 760 patients (5 randomized multiple trials and 6 cohort studies).Summary analysis showed that there was no significant difference in the success rate between sensei robots and traditional manual navigation surgery (OR=1.21, 95%CI:0.78-1.86, P=0.16;MD=5.00, 95%CI:-10.64-20.64, P<0.000 01).RCT pressure group showed that the robot group had longer operation time (MD=30.00, 95%CI:21.65-38.35), and radiation time (MD=-8.37, 95%CI:-11.37-5.37, P<0.000 1), but reduced radiation dose (SMD=-0.73, 95%CI:-1.19-0.26, P=0.002).The main complications of surgery (OR=1.11, 95%CI:0.75-1.64, P=0.62) and minor complications (OR=1.02, 95%CI:0.41~2.52) were not statistically significant.Conclusion: Compared with traditional manual guidance, sensei robot can significantly reduce radiation exposure and radiation time, and there is no significant difference in operation time, effectiveness and safety.
- atrial fibrillation /
- left atrial appendage occluder /
- meta analysis /

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参考文献(25)

[1]	Kirchhof P, Benussi S, Kotecha D, et al.2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS[J].Europace, 2016, 18(11):1609-1678.
[2]	Chiang CE, Wu TJ, Ueng KC, et al.2016 Guidelines of the Taiwan Heart Rhythm Society and the Taiwan Society of Cardiology for the management of atrial fibrillation[J].J Formos Med Assoc, 2016, 115(11):893-952.
[3]	Macle L, Cairns J, Leblanc K, et al.2016 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation[J].Can J Cardiol, 2016, 32(10):1170-1185.
[4]	Olson MD, Phreaner N, Schuller JL, et al.Effect of catheter movement and contact during application of radiofrequency energy on ablation lesion characteristics[J].J Interv Card Electrophysiol, 2013, 38(2):123-129.
[5]	Hauptmann M, Børge Johannesen T, Gilbert ES, et al.Increased pancreatic cancer risk following radiotherapy for testicular cancer[J].Br J Cancer, 2016, 115(7):901-908.
[6]	Stahl CM, Meisinger QC, Andre MP, et al.Radiation Risk to the Fluoroscopy Operator and Staff[J].AJR Am J Roentgenol, 2016, 207(4):737-744.
[7]	Bessière F, Zikry C, Rivard L, et al.Contact force with magnetic-guided catheter ablation[J].Europace, 2018, 20(suppl_2):ii1-ii4.
[8]	Di Biase L, Paoletti Perini A, Mohanty P, et al.Visual, tactile, and contact force feedback:which one is more important for catheter ablation? Results from an in vitro experimental study[J].Heart rhythm, 2014, 1(3)1:506-513.
[9]	Chun KRJ, Schmidt B, Köktürk B et al.Catheter ablation-new developments in robotics[J].Herz, 2008, 33(8):586-589.
[10]	Ahmed H, Reddy VY.Technical advances in the ablation of atrial fibrillation[J].Heart Rhythm, 2009, 6(8 Suppl):S39-S44.
[11]	Saliba W, Reddy VY, Wazni O, et al.Atrial fibrillation ablation using a robotic catheter remote control system:initial human experience and long-term follow-up results[J].J Am Coll Cardiol, 2008, 51(25):2407-2411.
[12]	Kautzner J, Peichl P, Cihák R, et al.Early experience with robotic navigation for catheter ablation of paroxysmal atrial fibrillation[J].Pacing Clin Electrophysiol, 2010, 32(Suppl 1):S163-S166.
[13]	Di Biase L, Wang Y, Horton R, et al.Ablation of atrial fibrillation utilizing robotic catheter navigation in comparison to manual navigation and ablation:single-center experience[J].J Cardiovasc Electrophysiol, 2009, 20(12):1328-1335.
[14]	Steven D, Servatius H, Rostock T, et al.Reduced fluoroscopy during atrial fibrillation ablation:benefits of robotic guided navigation[J].J Cardiovasc Electrophysiol, 2010, 21(1):6-12.
[15]	Thomas D, Scholz EP, Schweizer PA, et al.Initial experience with robotic navigation for catheter ablation of paroxysmal and persistent atrial fibrillation[J].J Electrocardiol, 2012, 45(2):95-101.
[16]	Ullah W, McLean A, Hunter RJ, et al.Randomized trial comparing robotic to manual ablation for atrial fibrillation[J].Heart Rhythm, 2014, 11(11):1862-1869.
[17]	Ullah W, Hunter RJ, Haldar S, et al.Comparison of robotic and manual persistent AF ablation using catheter contact force sensing:an international multicenter registry study[J].Pacing Clin Electrophysiol, 2015, 37(11):1427-1435.
[18]	Rillig A, Lin T, Schmidt B, et al.Experience matters:long-term results of pulmonary vein isolation using a robotic navigation system for the treatment of paroxysmal atrial fibrillation[J].Clin Res Cardiol, 2016, 105(2):106-116.
[19]	Dello Russo A, Fassini G, Conti S, et al.Analysis of catheter contact force during atrial fibrillation ablation using the robotic navigation system:results from a randomized study[J].J Interv Card Electrophysiol, 2016, 46(2):97-103.
[20]	Rillig A, Schmidt B, Di Biase L, et al.Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation:The Man and Machine Trial[J].JACC Clin Electrophysiol, 2017, 3(8):875-883.
[21]	van den Bruck JH, Sultan A, Lüker J, et al.Remote vs.conventional navigation for catheter ablation of atrial fibrillation:insights from prospective registry dat[J].Clin Res Cardiol, 2019, 108(3):298-308.
[22]	Arujuna A, Karim R, Zarinabad N, et al.A randomized prospective mechanistic cardiac magnetic resonance study correlating catheter stability, late gadolinium enhancement and 3 year clinical outcomes in robotically assisted vs.standard catheter ablation[J].Europace, 2015, 17(8):1241-1250.
[23]	Kim SC, Choi JR, Jeon BK.Physical analysis of the shielding capacity for a lightweight apron designed for shielding low intensity scattering X-rays[J].Sci Rep, 2016, 6:27721.
[24]	Scarà A, Sciarra L, De Ruvo E, et al.First evaluation of contact force during atrial fibrillation ablation using a novel robotic system (AMIGO®) combined to a force-sensing catheter.A single centre experience[J].Europace, 2016, 18(suppl_1), i4-i4.
[25]	Diaz R, Nuñez J, Aldea F, et al.Cost-effectiveness of radiofrequency catheter ablation of atrial fibrillation based on real-world data:Manual or robotic?[J].Value Health, 2017, 20:A613.