Persistence of Pulmonary Vein Isolation After Robotic Remote‐Navigated Ablation for Atrial Fibrillation and its Relation to Clinical Outcome

Robotic Remote Ablation for AF . Aims: A robotic navigation system (RNS, Hansen?) has been developed as an alternative method of performing ablation for atrial fibrillation (AF). Despite the growing application of RNS‐guided pulmonary vein isolation (PVI), its consequences and mechanisms of subsequent AF recurrences are unknown. We investigated the acute procedural success and persistence of PVI over time after robotic PVI and its relation to clinical outcome. Methods and Results: Sixty‐four patients (60.7 ± 9.8 years, 53 male) with paroxysmal AF underwent robotic circumferential PVI with 3‐dimensional left atrial reconstruction (NavX?). A voluntary repeat invasive electrophysiological study was performed 3 months after ablation irrespective of clinical course. Robotic PVI was successful in all patients without complication (fluoroscopy time: 23.5 [12–34], procedure time: 180 [150–225] minutes). Fluoroscopy time demonstrated a gradual decline but was significantly reduced after the 30th patient following the introduction of additional navigation software (34 [29–45] vs 12 [9–17] minutes; P < 0.001). A repeat study at 3 months was performed in 63% of patients and revealed electrical conduction recovery in 43% of all PVs. Restudied patients without AF recurrence (n = 28) showed a significantly lower number of recovered PVs (1 (0–2) vs 2 (2–3); P = 0.006) and a longer LA‐PV conduction delay than patients with AF recurrences (n = 12). Persistent block of all PVs was associated with freedom from AF in all patients. At 3 months, 67% of patients were free of AF, while reablation of recovered PVs led to an overall freedom from AF in 81% of patients after 1 year. Conclusion: Robotic PVI for PAF is safe, effective, and requires limited fluoroscopy while yielding comparable success rates to conventional ablation approaches with PV reconduction as a common phenomenon associated with AF recurrences. (J Cardiovasc Electrophysiol, Vol. 21, pp. 1079‐1084)     

Robotic navigation and ablation

Robotic technologies have been developed to allow optimal catheter stability and reproducible catheter movements with the aim of achieving contiguous and transmural lesion delivery. Two systems for remote navigation of catheters within the heart have been developed; the first is based on a magnetic navigation system (MNS) Niobe, Stereotaxis, Saint-Louis, Missouri, USA, the second is based on a steerable sheath system (Sensei, Hansen Medical, Mountain View, CA, USA). Both robotic and magnetic navigation systems have proven to be feasible for performing ablation of both simple and complex arrhythmias, particularly atrial fibrillation. Studies to date have shown similar success rates for AF ablation compared to that of manual ablation, with many groups finding a reduction in fluoroscopy times. However, the early learning curve of cases demonstrated longer procedure times, mainly due to additional setup times. With centres performing increasing numbers of robotic ablations and the introduction of a pressure monitoring system, lower power settings and instinctive driving software, complication rates are reducing, and fluoroscopy times have been lower than manual ablation in many studies. As the demand for catheter ablation for arrhythmias such as atrial fibrillation increases and the number of centres performing these ablations increases, the demand for systems which reduce the hand skill requirement and improve the comfort of the operator will also increase.     

Robotic navigation in catheter ablation for paroxysmal atrial fibrillation: midterm efficacy and predictors of postablation arrhythmia recurrences

Robotic Navigation in Ablation of Paroxysmal AF . Introduction: Remote navigation systems represent a novel strategy for catheter ablation of atrial fibrillation (AF). The goal of this study is to describe a single‐center experience with the electromechanical robotic system (Sensei, Hansen Medical) in treatment of patients with paroxysmal AF. Methods: Out of 200 patients who underwent robotically guided ablation for AF between 2007 and 2009 at our institute, 100 patients (29 women, age 56.5 ± 10 years) had paroxysmal AF refractory to antiarrhythmic drugs. Electroanatomic mapping using NavX system (St. Jude Medical) provided anatomical shell for subsequent circumferential ablation with robotic catheter (Artisan) loaded with a 3.5‐mm, open‐irrigation, cooled‐tip ablation catheter. Results: A mean of 69 radiofrequency current applications (duration 2082 ± 812 seconds) were delivered to achieve circumferential electrical isolation of pulmonary venous antra. Total procedural time reached 222 ± 54 minutes. The mean fluoroscopic time was 11.9 ± 7.8 minutes. There were no major procedure‐related complications. After a median follow‐up of 15 months (range 3‐28 months), 63% of the patients were free from any atrial arrhythmias ≥ 30 seconds after the single procedure. Success rate increased to 86% after 1.2 procedures. Multivariate analysis revealed that only predictor of recurrent AF/AT was shorter overall procedural time (207 ± 36 vs 236 ± 64 minutes in patients with and without recurrences, respectively, P = 0.0068). Conclusions: This study demonstrates feasibility and safety of robotic navigation in catheter ablation for paroxysmal AF. Midterm follow‐up documents success rate comparable to other technologies and potential for improvement in more extensive ablation along the ridges with thicker myocardium. (J Cardiovasc Electrophysiol, Vol. 22, pp. 534‐540 May 2011)     

Ablation of Atrial Fibrillation Utilizing Robotic Catheter Navigation in Comparison to Manual Navigation and Ablation: Single‐Center Experience

Background: Robotic catheter navigation and ablation either with magnetic catheter driving or with electromechanical guidance have emerged in the recent years for the treatment of atrial fibrillation. Objective: The aim of this study was to compare our center's experience of atrial fibrillation ablation using the Hansen Robotic Medical System with our current manual ablation technique in terms of acute and chronic success, as well as procedure time and radiation exposure to both the patient and the operator. Methods: A total of 390 consecutive patients with symptomatic and drug‐resistant atrial fibrillation (289 males, 62 ± 11 years) were prospectively enrolled in the study. All patients underwent the procedure either with conventional manual ablation (group 1, n = 197) or with the robotic navigation system (RNS) (group 2, n = 193). Results: The success rate for RNS was 85% (164 patients), while for manual ablation it was 81% (159 patients) (p = 0.264) at 14.1 ± 1.3 months with AADs previously ineffective. Fluoroscopy time was significantly lower for RNS (48.9 ± 24.6 minutes for RNS vs. 58.4 ± 20.1 minutes for manual ablation, P < 0.001). Mean fluoroscopy time was statistically reduced after 50 procedures (61.8 ± 23.2 minutes for first 50 cases vs. 44.5 ± 23.6 minutes for subsequent procedures, P < 0.0001). Conclusion: Robotic navigation and ablation of atrial fibrillation is safe and effective. Fluoroscopy time decreases with experience.     

磁导航系统在心房颤动导管消融中的应用研究

目的探讨磁导航（MNS）指导下心房颤动（房颤）导管消融的有效性和安全性。 方法纳入2012年10月至2021年3月南京医科大学附属无锡人民医院心内科住院的成功实施了MNS指导下导管消融的433例房颤患者（磁导航组）,穿刺房间隔后,MNS指导下,盐水灌注MNS消融导管行左心房建模和肺静脉前庭电隔离,隔离后采用“牛眼图”软件确认。同期112例患者作为对照组（手动组）完成传统手动消融。记录并比较两组患者的手术操作时间、X线曝光时间、X线曝光量、手术成功率和手术相关并发症等临床情况。术后12个月内每月随访一次。磁导航组根据入组时间,将最初50例患者作为学习曲线组,后续383例患者按时间分成磁导航1组（190例）和磁导航2组（193例）,分析该手术的学习曲线。 结果①磁导航组和手动组患者性别、年龄、身高、体重、左心房内径和左心室射血分数等基线情况差异无统计学意义。与手工组相比,磁导航组肺静脉前庭隔离急性成功率略低（98.8％对98.2％,P>0.05）,手术操作时间略长［（152.7±27.8）min对（149.7±27.3）min,P>0.05］,X线曝光时间明显短［（8.4±4.3）min对（16.8±10.9）min,P<0.05］。②学习曲线组、磁导航1组与磁导航2组间年龄、性别和体重等基线情况差异无统计学意义（P>0.05）。与学习曲线组比较,磁导航1组与磁导航2组X线曝光时间显著减少［（13.2±7.2）min对（8.0±3.5）min、（7.6±3.3）min,P<0.05］;而磁导航1组与2组间差异无统计学意义（P>0.05）。③围术期磁导航组有2例血胸（锁骨下静脉穿刺所致）和3例腹股沟血肿,无其他手术相关并发症。手工组出现1例心脏压塞、1例肺静脉狭窄、1例脑梗死和3例腹股沟血肿。④磁导航组阵发性房颤与非阵发性房颤1年消融成功率均略高于手工组（71.0％对68.9％,P>0.05;57.2％对55.3％,P>0.05）差异均无统计学意义。 结论与手动消融相比,MNS指导下的房颤导管消融术中X线曝光时间和手术并发症发生率显著减少,学习曲线较短,表明MNS指导下的房颤导管消融有较好的安全性和有效性。     

环肺静脉消融联合心房复杂碎裂电位消融治疗心房颤动的多中心临床研究

目的 观察环肺静脉消融（CPVA）联合心房复杂碎裂电位（CFAEs）消融治疗心房颤动（房颤）的有效性和安全性.方法 通过多中心临床实时注册研究的方式收集CPVA联合CFAEs消融治疗房颤的777例有效病例资料,分析其成功率和复发率,对心脏结构和功能的影响,以及并发症发生情况.结果 在平均（6.7±3.7）个月的随访期间,CPVA联合CFAEs消融治疗房颤的成功率为81.2%,复发率为18.8%.阵发性房颤成功率为88%,持续性房颤成功率为79.5%.消融术成功患者左心房内径（LAD）、左心室舒张末期内径（LVEDD）明显减小,左心室射血分数（LVEF）显著升高,P＜0.05.消融总的并发症发生率为0.9%,其中穿刺部位血肿4例,动静脉瘘2例,心脏压塞1例.结论 CPVA联合CFAEs消融治疗房颤安全、有效,对于持续性房颤,其优势尤为明显.     

Comparison of Cryoballoon and Radiofrequency Ablation of Pulmonary Veins in 40 Patients with Paroxysmal Atrial Fibrillation: A Case‐Control Study

Introduction: Ablation of pulmonary veins (PV) is an established therapeutic option for patients with symptomatic drug‐refractory paroxysmal atrial fibrillation (AF). Radiofrequency (RF) is currently the most widespread energy source for PV ablation. Cryothermal energy applied with a cryoballoon technique as an alternative has recently evolved. Methods and Results: In a case‐control setting, we compared 20 patients with paroxysmal AF who underwent their first PV ablation with the cryoballoon technique to 20 matched patients with conventional RF ablation. In the case of persistent electrical potentials after cryoballoon ablation, it was combined with ablation with a conventional cryocatheter. All patients performed daily event recording for 3 months after ablation procedure. Ablation parameters and success rate after 3 and 6 months were compared. In the cryoballoon group, the overall success rate was 55% (50% in the cryoballoon only group [14 patients] and 66% in the combination group [6 patients]), as opposed to the RF group with 45%. AF episode burden was lower after cryoballoon ablation. There was no significant difference between cryoballoon and RF ablation regarding procedure parameters. In the cryoballoon group, 3 phrenic nerve palsies occurred using the 23 mm balloon that resolved spontaneously. Conclusion: PV ablation with the cryoballoon technique is feasible and seems to have a similar success rate in comparison to RF ablation. Procedure‐ and fluoroscopy duration are not longer than in conventional RF ablation.     

Catheter ablation of atrial fibrillation in octogenarians: safety and outcomes

AF Ablation in Octogenarians. Introduction: Radiofrequency catheter ablation (RFCA) is an effective treatment for atrial fibrillation (AF), although studies evaluating the role of RFCA have largely excluded elderly patients. We report the safety and outcomes of RFCA of AF in octogenarians. Methods and Results: From 2008 to 2011, out of 2,754 consecutive patients undergoing RFCA of AF, 103 (3.7%) had ≥80 years (age 85 ± 3 years, 4 with >90 years). Pulmonary vein (PV) antrum isolation was performed in paroxysmal AF. In nonparoxysmal AF, ablation was extended to the entire left atrial posterior wall and to complex fractionated electrograms. Non‐PV triggers were disclosed by isoproterenol challenge at the end of the procedure and targeted for ablation. Octogenarians presented a high rate of non‐PV triggers (84% vs 69%, P = 0.001), especially in patients with paroxysmal AF (62% vs 19%, P < 0.001); non‐PV triggers were most commonly mapped in the coronary sinus (54%), left atrial appendage (32%), interatrial septum and superior vena cava (14%). After a mean follow‐up of 18 ± 6 months, 71 (69%) octogenarians remained free from AF recurrence off antiarrhythmic drugs after a single procedure (vs 71% in patients <80 years, P = 0.65). The success rate reached 87% after 2 procedures. Total periprocedural complication rates also did not differ between the 2 age groups. Conclusions: RFCA of AF is safe and effective in octogenarians. A high rate of non‐PV triggers is present in these patients, and targeting multiple structures other than the pulmonary veins is often necessary to achieve long‐term success. (J Cardiovasc Electrophysiol, Vol. 23, pp. 687‐693, July 2012)     

Robotically Assisted Ablation Produces More Rapid and Greater Signal Attenuation Than Manual Ablation

Introduction: Robotic remote catheter ablation potentially provides improved catheter‐tip stability, which should improve the efficiency of radiofrequency energy delivery. Percentage reduction in electrogram peak‐to‐peak voltage has been used as a measure of effectiveness of ablation. We tested the hypothesis that improved catheter‐tip stability of robotic ablation can diminish signals to a greater degree than manual ablation. Methods: In vivo NavX? maps of 7 pig atria were constructed. Separate lines of ablation were performed robotically and manually, recording pre‐ and postablation peak‐to‐peak voltages at 10, 20, 30, and 60 seconds and calculating signal amplitude reduction. Catheter ablation settings were constant (25W, 50°, 17 mL/min, 20–30 g catheter tip pressure). The pigs were sacrificed and ablation lesions correlated with NavX maps. Results: Robotic ablation reduced signal amplitude to a greater degree than manual ablation (49 ± 2.6% vs 29 ± 4.5% signal reduction after 1 minute [P = 0.0002]). The mean energy delivered (223 ± 184 J vs 231 ± 190 J, P = 0.42), power (19 ± 3.5 W vs 19 ± 4 W, P = 0.84), and duration of ablation (15 ± 9 seconds vs 15 ± 9 seconds, P = 0.89) was the same for manual and robotic. The mean peak catheter‐tip temperature was higher for robotic (45 ± 5°C vs 42 ± 3°C [P < 0.0001]). The incidence of >50% signal reduction was greater for robotic (37%) than manual (21%) ablation (P = 0.0001). Conclusion: Robotically assisted ablation appears to be more effective than manual ablation at signal amplitude reduction, therefore may be expected to produce improved clinical outcomes.     

Robotic magnetic navigation-guided catheter ablation establishes highly effective pulmonary vein isolation in patients with paroxysmal atrial fibrillation when compared to conventional ablation techniques

Introduction

Pulmonary vein isolation (PVI) is a pivotal part of ablative therapy for atrial fibrillation (AF). Currently, there are multiple techniques available to realize PVI, including: manual-guided cryoballoon (MAN-CB), manual-guided radiofrequency (MAN-RF), and robotic magnetic navigation-guided radiofrequency ablation (RMN-RF). There is a lack of large prospective trials comparing contemporary RMN-RF with the more conventional ablation techniques. This study prospectively compared three catheter ablation techniques as treatment of paroxysmal AF.

Methods

This multicenter, prospective study included patients with paroxysmal AF who underwent their first ablation procedure. Procedural parameters (including procedural efficiency), complication rates, and freedom of AF during 12-month follow-up, were compared between three study groups which were defined by the utilized ablation technique.

Results

A total of 221 patients were included in this study. Total procedure time was significantly shorter in MAN-CB (78 ± 21 min) compared to MAN-RF (115 ± 41 min; p < .001) and compared to RMN-RF (129 ± 32 min; p < .001), whereas it was comparable between the two radiofrequency (RF) groups (p = .062). A 3% complication rate was observed, which was comparable between all groups. At 12-month follow-up, AF recurrence was observed in 40 patients (19%) and was significantly lower in the robotic group (MAN-CB 19 [24%], MAN-RF 16 [23%], RMN-RF 5 [8%] AF recurrences, p = .045) (multivariate hazard ratio of RMN-RF on AF recurrence 0.32, 95% confidence interval: 0.12–0.87, p = .026).

Conclusion

RMN-guided PVI results in high freedom of AF in patients with paroxysmal AF, when compared to cryoablation and manual RF ablation. Cryoablation remains the most time-efficient ablation technique, whereas RMN nowadays has comparable efficiency with manual RF ablation.     

心房颤动导管消融术后早期复发的直流电复律临床分析

目的对心房颤动(简称房颤)导管消融术后1个月内复发行直流电复律的患者的临床特征进行前瞻性研究。方法丙泊酚镇静、禁食状态下,单向波同步电复律,电极板置于心尖-胸骨旁右侧,能量依次采用300,360,360J。结果共入选23例患者,年龄58±13岁,房颤病史6.8±5.0年,左房直径41.9±9.8mm,左室射血分数0.58±0.11。复发心律失常中12例为心房扑动,10例为房颤,1例为房性心动过速。共进行27次电复律,19次(70.4%)即刻复律成功,其中15次1次放电复律成功。1例复律后出现窦性心动过缓伴交界心律,1例丙泊酚镇静时出现呼吸暂停。随访8.5±3.7个月,52.2%的患者为窦性心律。即刻复律成功组其远期成功率为64.7%,即刻复律失败的远期均不成功,两组间有显著性差异(P=0.014)。1次放电即可成功者远期成功率为69.2%,需要多次放电的患者远期成功率为20.0%,两组间有显著性差异(P=0.036)。结论直流电复律可安全有效地用于房颤导管消融术后早期复发的患者,即刻电复律成功是远期成功的预测因素,复律时需要多次放电的远期成功率低。     

Operator learning curve and clinical outcomes of zero fluoroscopy catheter ablation of atrial fibrillation,supraventricular tachycardia,and ventricular arrhythmias

Purpose

To investigate the learning curve for atrial fibrillation (AF), supraventricular tachycardia (SVT), and premature ventricular contraction (PVC) radiofrequency ablation (RFA) using zero fluoroscopy.

Methods

This is a retrospective, single-center study of 167 patients undergoing ablation between 2016 and 2019. Minimal fluoroscopy approach was initiated after the first 20 cases of PVI and SVT RFA. Procedures were divided consecutively into increments of 10 cases to determine operator learning curve.

Results

A total of 64 (38%) had SVT ablations, 26 (16%) had PVC ablations, and 77 (46%) had AF and underwent PVI. For SVT RFA, fluoroscopy time improved from 4.1?±?3.5 min during the first 10 cases to 0.8?±?1.2 min after 50 cases (p?=?0.0001). Sixty-two out of 64 (97%) of cases were successful. In PVC RFA, fluoroscopy time was 7.7?±?5.5 min for the first 5, 2.3?±?3.4 min after 15, and 0 min after 20 cases (p?=?0.0008). Twenty-four out of 26 (92%) of cases were acutely successful with recurrence in 2/26 (8%) of patients over 9?±?9 months. In PVI, fluoroscopy time was 9.9?±?3.3 min over the first 20 cases, 2.6?±?2.3 min after 40 cases, and 0.1 min after 50 cases (p?<?0.0001). PVI procedure time was 170?±?34 min after 60 cases from 235?±?41 min initially (p 0.001). Six out of 77 (8%) had AF recurrence at 12 months.

Conclusions

Zero fluoroscopy ablation for AF, SVT, and PVC can be safely achieved without increasing procedure time. The steepest learning curve occurs over the first 20, 15, and 40 cases for SVT, PVC, and PVI ablation respectively.

     

Initial experience with robotic navigation for catheter ablation of paroxysmal and persistent atrial fibrillation

Background and PurposeRemote robotic navigation (RRN) technology has been developed to facilitate catheter ablation of symptomatic atrial fibrillation (AF). Here, we assess procedural parameters of AF ablation obtained during initial use of RRN compared with a control group treated with a manual ablation approach.MethodsConsecutive patients with symptomatic paroxysmal or persistent AF were subjected to radiofrequency catheter ablation with RRN (Sensei X [Hansen Medical, Mountain View, CA]; n = 25; mean age, 60 ± 2.3 years) or using the standard manual technique (n = 61; mean age, 62 ± 1.4 years). A circumferential pulmonary vein isolation approach guided by 3-dimensional electroanatomical mapping was followed.ResultsRemote robotic navigation was associated with reduction of overall fluoroscopy time by 26%. In a case-control subgroup analysis comparing 25 patients with similar clinical characteristics from each group, mean fluoroscopy time was reduced by 22%. Acute isolation of pulmonary veins was achieved in 97% (RRN) and 96% (conventional ablation), respectively. Ablation times and frequency of adverse events were not significantly different among study groups.ConclusionsThe early use of RRN resulted in a significant reduction of overall fluoroscopy time and was equally effective and safe compared with manual catheter ablation.     

Canadian Cardiovascular Society atrial fibrillation guidelines 2010: catheter ablation for atrial fibrillation/atrial flutter

Catheter ablation of atrial fibrillation (AF) offers a promising treatment for the maintenance of sinus rhythm in patients for whom a rhythm control strategy is desired. While the precise mechanisms of AF are incompletely understood, there is substantial evidence that in many cases (particularly for paroxysmal AF), ectopic activity most commonly located in and around the pulmonary veins of the left atrium plays a central role in triggering and/or maintaining arrhythmic episodes. Catheter ablation involves electrically disconnecting the pulmonary veins from the rest of the left atrium to prevent AF from being triggered. Further substrate modification may be required in patients with more persistent AF. Successful ablation of AF has never been shown to alter mortality or obviate the need for oral anticoagulation; thus, the primary indication for this procedure should be improvement of symptoms caused by AF. The success rate of catheter ablation for AF is superior to the efficacy of antiarrhythmic drugs, but success is still in the range of 75%-90% after 2 procedures. Ablation is also associated with a complication rate of 2%-3%. Thus, ablation should primarily be used as a second-line therapy after failure of antiarrhythmic drugs. In contrast to AF, catheter ablation of atrial flutter has a higher success rate with a smaller incidence of complications. Thus, catheter ablation for atrial flutter may be considered a first-line alternative to antiarrhythmic drugs.     

Robot-assisted navigation in atrial fibrillation ablation—Of any benefits?

In recent years, catheter ablation has been established as a safe and effective treatment for atrial fibrillation (AF). The benefits of robotic catheter navigation technology and techniques for AF ablation are currently a frequent topic of discussion. Most clinical trials have suggested that robotic ablation is (at least) as effective as the manual approach. The most important potential advantages of robotic ablation include excellent catheter stability and accuracy of its movement, reduced fluoroscopic time, catheter contact monitoring, improved comfort of the operator during the procedure as they can sit most of the time unexposed to radiation and, last but not least, a very short learning curve potentially allowing for more complicated procedures (persistent forms of AF, structural ventricular tachycardias, congenital heart disease).     

Circumferential ablation with pulmonary vein isolation in permanent atrial fibrillation

Each of the main approaches to catheter ablation of atrial fibrillation (AF, segmental and circumferential) is associated with limited efficacy in patients with permanent AF. The objective is to report outcomes of circumferential ablation with pulmonary vein (PV) isolation, determined using a circular mapping catheter, in patients with permanent AF and determine relations between the duration of permanent AF and efficacy. The patient population was composed of 41 consecutive patients (34 men; age 58 +/- 11 years) with permanent AF who underwent radiofrequency catheter ablation through circumferential ablation with PV isolation. They were in permanent AF for 2.3 +/- 3.6 years, and 3.4 +/- 2.2 cardioversion procedures and 1.9 +/- 0.8 class I/III antiarrhythmic drugs had failed. After a follow-up of 11 +/- 2 months, the single-procedure success rate was 36% (n = 15) with an additional 12% (n = 5) showing improvement. With repeat procedures in 19%, the success rate was 54% (n = 22) with an additional 12% (n = 5) showing improvement. All patients who underwent repeat ablations had recovered PV conduction. Single-procedure success was higher in patients who were in permanent AF for < or =1 year compared with those in permanent AF for >1 year (50% vs 20%, respectively, p = 0.05). A major complication occurred in 4 patients (8%), including 3 patients with vascular complications and 1 with stroke. In conclusion, study results suggest that circumferential ablation with PV isolation has moderate efficacy in patients with permanent AF. Efficacy is limited in those in continuous AF for >12 months.     

CARTO系统引导下导管消融治疗老年心房颤动患者50例临床疗效及安全性分析

目的：分析在CARTO系统引导下以环肺静脉口消融术为核心联合其他消融术式导管消融治疗老年心房颤动（房颤）的疗效和安全性,并分析其术后复发的危险因素。方法于2009年7月至2011年7月在解放军第252医院住院并随访接受导管射频消融治疗的50例老年房颤患者,男37例,女13例,年龄60～76（66.78±4.09）岁。其中阵发性房颤43例,持续性房颤5例,永久性房颤（＜2年）2例。采取CARTO三维标测系统指导下以环肺静脉口消融术为核心联合其他术式导管射频消融治疗,消融的主要终点为肺静脉完全电隔离。术后连续跟踪随访12个月,观察手术的成功率、复发率、复发的相关因素分析和并发症发生情况。结果50例患者术后即刻成功率为100%。术后随访显示,术后1年消融成功率为80%。术后发生心包填塞1例（2%）,经心包穿刺置管术后缓解;术后发生无压塞症状的心包少量积液2例（4%）,术后出现双侧少量渗出性胸腔积液1例（2%）;术后穿刺部位血肿2例（4%）。射频消融术后6个月,窦性心律维持成功的（成功组）40例患者,心脏彩超检查显示左房内径（LAD）均有不同程度的缩小,而窦性心律未能维持的（复发组）10例患者,LAD无明显变化;两组治疗前后平均LAD差值差异具有统计学意义[（4.64±1.12） vs （0.40±0.61）mm,P＜0.01],但两组患者的左室射血分数较术前均无明显变化。术后12个月,共复发10例（20%）,其中2例（4%）为永久性房颤患者,3例（6%）为持续性房颤患者,5例（10%）为阵发性房颤患者。老年持续性房颤、永久性房颤和术前LAD是房颤经导管射频消融术后复发的危险因素。结论 CARTO三维标测系统指导下导管射频消融治疗老年房颤是安全有效的。     

Left atrial radiofrequency ablation during cardiac surgery in patients with atrial fibrillation

Introduction: Intraoperative left atrial radiofrequency (RF) ablation recently has been suggested as an effective surgical treatment for atrial fibrillation (AF). The aim of this study was to verify the outcome of this technique in a controlled multicenter trial. Methods and Results: One hundred three consecutive patients (39 men and 65 women; age 62 ± 11 years) affected by AF underwent cardiac surgery and RF ablation in the left atrium (RF group). The control group consisted of 27 patients (6 men and 21 women; age 64 ± 7 years) with AF who underwent cardiac surgery during the same period and refused RF ablation. Mitral valve disease was present in 89 (86%) and 25 (92%) patients, respectively (P = NS). RF endocardial ablation was performed in order to obtain isolation of both right and left pulmonary veins, a lesion connecting the previous lines, and a lesion connecting the line encircling the left veins to the mitral annulus. Upon discharge from the hospital, sinus rhythm was present in 65 patients (63%) versus 5 patients (18%) in the control group (P < 0.0001). Mean time of cardiopulmonary bypass was longer in the RF group (148 ± 50 min vs 117 ± 30 min, P = 0.013). The complication rate was similar in both groups, but RF ablation‐related complications occurred in 4 RF group patients (3.9%). After a mean follow‐up of 12.5 ± 5 months (range 4–24), 83 (81%) of 102 RF group patients were in stable sinus rhythm versus 3 (11%) of 27 in the control group (P < 0.0001). The success rate was similar among the four surgical centers. Atrial contraction was present in 66 (79.5%) of 83 patients in the RF group in sinus rhythm. Conclusion: Endocardial RF left atrial compartmentalization during cardiac surgery is effective in restoring sinus rhythm in many patients. This technique is easy to perform and reproducible. Rare RF ablation‐related complications can occur. During follow‐up, sinus rhythm persistence is good, and biatrial contraction is preserved in most patients. (J Cardiovasc Electrophysiol, Vol. 14, pp. 1289‐1295, December 2003)     

Simultaneous assessment of contact pressure and local electrical coupling index using robotic navigation

Purpose

Contact with cardiac tissue is a determinant of lesion efficacy during atrial fibrillation (AF) ablation. The Sensei®X Robotic Catheter System (Hansen Medical, CA) has been validated for contact force sensing. The electrical coupling index (ECI) from the EnSite Contact? system (St. Jude Medical, MN) has been validated as an indicator of tissue contact. We aimed at analyzing ECI behavior during radiofrequency (RF) pulses maintaining a stable contact through the robotic navigation contact system.

Methods

In 15 patients (age, 59?±?12) undergoing AF ablation, pulmonary vein (PV) isolation was guided by the Sensei®X System, employing the Contact? catheter.

Results

During the procedure, we assessed ECI changes associated with adequate contact based on the IntelliSense® force-sensing technology (Hansen Medical, CA. Baseline contact (27?±?8 g/cm²) ECI value was 99?±?13, whereas ECI values in a noncontact site (0 g/cm²) and in a light contact site (1–10 g/cm²) were respectively 66?±?12 and 77?±?10 (p?<?0.0001). Baseline contact ECI values were not different depending on AF presentation (paroxysmal AF, 98?±?9; persistent AF, 100?±?9) or on cardiac rhythm (sinus rhythm, 97?±?7; AF,101?±?10). In all PVs, ECI was significantly reduced during and after ablation (ECI during RF, 56?±?15; ECI after RF, 72?±?16; p?<?0.001). A mean reduction of 32.2 % during RF delivery and 25.4 % immediately after RF discontinuation compared with baseline ECI was observed.

Conclusions

Successful PV isolation is associated with a significant decrease in ECI of at least 20 %. This may be used as a surrogate marker of effective lesion in AF ablation.     

Study Design of the Man and Machine Trial: A Prospective International Controlled Noninferiority Trial Comparing Manual with Robotic Catheter Ablation for Treatment of Atrial Fibrillation

Study Design of the Man and Machine Trial. Background: Pulmonary vein isolation (PVI) has become the cornerstone procedure for the treatment of symptomatic drug‐resistant atrial fibrillation (AF). At the present time, circumferential PVI (CPVI) using irrigated radiofrequency (RF) is the mostly used ablation technique. However, for CPVI, precise catheter navigation and excellent catheter stability is crucial thereby requiring experienced operators. Robotic navigation systems have been introduced to facilitate catheter navigation and to improve catheter stability, therefore potentially increasing procedural success and making CPVI accessible to less experienced operators. To date, no prospective randomized trial has evaluated the efficacy and safety of CPVI using RNS compared to manually performed ablation. Methods: In this prospective international multicenter noninferiority trial, 258 patients with either paroxysmal or short‐standing persistent AF will be randomized for comparison of PVI using either manual or robotic ablation. In all patients, CPVI will be performed using irrigated RF ablation in combination with a 3D mapping system. The primary endpoint of the trial is the absence of AF or atrial tachycardia without antiarrhythmic drug therapy during 12‐month follow‐up. Secondary endpoints will be evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, as well as the incidence of esophageal injury assessed by endoscopy within 48 hours after the procedure. Conclusion: The “Man and Machine Trial” is the first prospective international randomized controlled multicenter noninferiority trial to compare manually performed CPVI with robotically navigated CPVI, evaluating both the safety and efficacy of the 2 techniques during a 12‐month follow‐up period. (J Cardiovasc Electrophysiol, Vol. 24, pp. 40‐46, January 2013)