Robot-assisted uterine artery embolization: a first-in-woman safety evaluation of the Magellan System.

PURPOSE: To provide a technical description of robot-assisted uterine artery embolization and to investigate the safety and feasibility of the Magellan (Hansen Medical, Mountain View, California, USA) robotic catheter in this complex arterial bed. MATERIALS AND METHODS: Five women (mean age, 48.8 y) underwent robot-assisted bilateral uterine artery embolization over a 10-month period using the Magellan robotic catheter. Demographic, clinicopathologic, and endovascular performance metric data (fluoroscopy and cannulation times) were recorded as well as short-term outcomes. RESULTS: Robotic cannulation of bilateral internal iliac and uterine arteries was successful in all cases. Median right and left internal iliac artery cannulation and total fluoroscopy times were 3 minutes (interquartile range [IQR], 1.5-4 min), 2 minutes (IQR, 1.5-4 min), and 11 minutes (IQR, 9.5-14 min). Median right and left uterine artery cannulation times were both 11 minutes (IQR, 6.5-15 min and 8-12 min, respectively). Technical success was 100%. All patients were discharged on postoperative day 1, and there were no major or access site complications. At 6 months after the procedure, all patients reported significant improvement of symptoms, with a median increase in health-related quality-of-life score of 58% (48.5%-61.75%). CONCLUSIONS: The use of the new-generation Magellan system in uterine artery embolization is feasible and appears to be safe. The additional navigational capability and added maneuverability of the NorthStar catheter (Hansen Medical, Mountain View, California) may facilitate selective catheterization of small iliac artery divisions and may be useful in any procedure where complex arterial selection is needed.

Robotics in invasive cardiac electrophysiology.

Robotic systems allow for mapping and ablation of different arrhythmia substrates replacing hand maneuvering of intracardiac catheters with machine steering. Currently there are four commercially available robotic systems. Niobe magnetic navigation system (Stereotaxis Inc., St Louis, MO) and Sensei robotic navigation system (Hansen Medical Inc., Mountain View, CA) have an established platform with at least 10 years of clinical studies looking at their efficacy and safety. AMIGO Remote Catheter System (Catheter Robotics, Inc., Mount Olive, NJ) and Catheter Guidance Control and Imaging (Magnetecs, Inglewood, CA) are in the earlier phases of implementations with ongoing feasibility and some limited clinical studies. This review discusses the advantages and limitations related to each existing system and highlights the ideal futuristic robotic system that may include the most promising features of the current ones.

Robotically controlled ablation for atrial fibrillation: the first real-world experience in Africa with the Hansen robotic system.

BACKGROUND: We report the first single-centre experience in Africa with the Sensei X robotic navigation system in an unselected subset of patients with atrial fibrillation (AF). METHODS: Data were recorded prospectively of all consecutive patients who underwent robotically assisted catheter ablation therapy using the Sensei X robotic navigation system at the Christiaan Barnard Memorial Hospital, Cape Town, South Africa, from July 2009 to July 2010. Outcomes were defined at one and nine months. RESULTS: A total of 95 patients were included: 63% had only AF and 37% had AF plus atrial flutter. AF was of the persistent type in 81% of patients. The mean procedure, fluoroscopy and ablation times were 220.6 ± 89.6 min, 31.0 ± 20.4 min, and 61.3 ± 28.1 min, respectively. Both fluoroscopy and procedure times were significantly longer for the first 19 patients compared with the remaining 76 patients (43.5 ± 22.7 vs 27.8 ± 18.5 min and 274.7 ± 90.2 vs 207.1 ± 84.7 min, respectively, p = 0.002). The procedural endpoint of the study was successfully achieved in all patients. After one attempt, 27% were discharged from hospital off anti-arrhythmic drugs (AADs). At a median of nine months' follow up, 74% were AF-free off AADs, and 11% were AF-free on AADs, yielding a total freedom from AF of 84% without any redo procedures. Freedom from relapse after 1.12 procedures was 88%. CONCLUSION: The Sensei X robotic navigation system offers a safe and effective approach for the treatment of AF. There was a learning curve with regard to fluoroscopy and procedure time, after which point reduction in radiation exposure and operator strain, as well as improvement in procedure throughputs were even more pronounced.

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

BACKGROUND AND PURPOSE: Remote 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. METHODS: Consecutive 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. RESULTS: Remote 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. CONCLUSIONS: The early use of RRN resulted in a significant reduction of overall fluoroscopy time and was equally effective and safe compared with manual catheter ablation.

Persistence of pulmonary vein isolation after robotic remote-navigated ablation for atrial fibrillation and its relation to clinical outcome.

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.

Oesophageal temperature monitoring and incidence of oesophageal lesions after pulmonary vein isolation using a remote robotic navigation system.

AIMS: Oesophageal lesions (EL), a potential complication after pulmonary vein isolation (PVI), have been described recently. A new remote robotic navigation system (RNS; Hansen Medical) provides enhanced catheter stability along with more effective lesion placement. The aim of this prospective study was to evaluate temperature monitoring and incidence of EL when using RNS with an irrigated tip radiofrequency catheter for PVI. METHODS AND RESULTS: Circumferential PVI using RNS was performed in 73 patients (pts) with paroxysmal (n = 46, 63%) and persistent atrial fibrillation. An oesophageal temperature probe was placed in 58 (79.5%) pts and was integrated in the 3D-map (NavX). Power was limited to 25 W at the posterior wall, and in the case of an increase in temperature power was limited to 20 W. Endoscopy was performed in 42 pts within 24 h after PVI. In 44 of 58 (75.9%) pts, a significant rise in temperature (>39 degrees C) was observed. In 6 of 42 (14.3%) pts, an EL was found during endoscopy. In patients with EL, the body mass index (BMI) was significantly lower than in pts without EL (24.1 +/- 2.0 vs. 29.0 +/- 5.8, P = 0.047). The BMI of all patients with EL was <26, whereas all patients without EL had a BMI above 26. The EL showed brisk healing after re-endoscopy within 2 weeks in all pts. CONCLUSION: In patients undergoing PVI using the RNS, the incidence of EL is 14.3% when using power settings comparable to settings used in manual ablation. Patients with lower BMI (<26) are at higher risk for EL.

Reduced fluoroscopy during atrial fibrillation ablation: benefits of robotic guided navigation.

BACKGROUND: Recently, a nonmagnetic robotic navigation system (RN, Hansen-Sensei) has been introduced for remote catheter manipulation. OBJECTIVE: To investigate the influence of RN combined with intuitive 3-dimensional mapping on the fluoroscopy exposure to operator and patient during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) in a prospective randomized trial. METHODS: Sixty patients were randomly assigned to undergo PVI either using a RN guided (group 1; n = 30, 20 male, 62 +/- 7.7 years) or conventional ablation approach (group 2; n = 30, 14 male, 61 +/- 7.6 years). A 3-dimensional mapping system (NavX) was used in both groups. RESULTS: Electrical disconnection of the ipsilateral pulmonary veins (PVs) was achieved in all patients. Use of RN significantly lowered the overall fluoroscopy time (9 +/- 3.4 vs 22 +/- 6.5 minutes; P < 0.001) and reduced the operator's fluoroscopy exposure (7 +/- 2.1 vs 22 +/- 6.5 minutes; P < 0.001). The difference in fluoroscopy duration between both groups was most pronounced during the ablation part of the procedure (3 +/- 2.4 vs 17 +/- 6.3 minutes; P < 0.001). The overall procedure duration tended to be prolonged using RN without reaching statistical significance (156 +/- 44.4 vs 134 +/- 12 minutes, P = 0.099). No difference regarding outcome was found during a midterm follow-up of 6 months (AF freedom group 1 = 73% vs 77% in group 2 [P = 0.345]). CONCLUSION: The use of RN for PVI seems to be effective and significantly reduces overall fluoroscopy time and operator's fluoroscopy exposure without affecting mid-term outcome after 6-month follow-up.

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.

Remote navigation systems in electrophysiology.

Today, atrial fibrillation (AF) is the dominant indication for catheter ablation in big electrophysiologists (EP) centres. AF ablation strategies are complex and technically challenging. Therefore, it would be desirable that technical innovations pursue the goal to improve catheter stability to increase the procedural success and most importantly to increase safety by helping to avoid serious complications. The most promising technical innovation aiming at the aforementioned goals is remote catheter navigation and ablation. To date, two different systems, the NIOBE magnetic navigation system (MNS, Stereotaxis, USA) and the Sensei robotic navigation system (RNS, Hansen Medical, USA), are commercially available. The following review will introduce the basic principles of the systems, will give an insight into the merits and demerits of remote navigation, and will further focus on the initial clinical experience at our centre with focus on pulmonary vein isolation (PVI) procedures.

Atrial fibrillation ablation using a robotic catheter remote control system: initial human experience and long-term follow-up results.

OBJECTIVES: We present the initial clinical human experience with the use of a robotic remote navigation system (Hansen Medical, Mountain View, California), to perform left and right atrial mapping and radiofrequency ablation of atrial fibrillation (AF) and atrial flutter (AFL). BACKGROUND: Catheter ablation is an established curative modality for various arrhythmias. A robotic steerable sheath system (SSS) (Hansen Medical) allows better catheter stability and greater degrees of freedom of catheter movement. METHODS: A total of 40 patients (mean age 57 years) with antiarrhythmic drug (AAD)-refractory AF (23 had also concomitant documented typical AFL) were studied. Three-dimensional reconstruction of the corresponding atrial chamber anatomy was performed with the CARTO electroanatomic mapping system (Biosense Webster, Diamond Bar, California or the EnSite NavX system (St. Jude Medical, Minneapolis, Minnesota) in combination with the Artisan catheter (Hansen Medical). In patients undergoing AF ablation, 2 transseptal punctures were performed under intracardiac ultrasound (ICE) guidance, with one of the punctures being performed using SSS. Pulmonary vein antrum isolation was performed with a 3.5-mm thermocool catheter manipulated with the use of the SSS and was verified by circular mapping. Patients were followed clinically for recurrence of arrhythmia with an event transmitter and ambulatory holter monitoring. Clinical recurrence of AF/AFL was defined as AF/AFL episodes >1 min in duration. RESULTS: Pulmonary vein antrum isolation was performed in 40 patients, including 23 with concomitant typical AFL ablation. All pulmonary veins, including the superior vena cava, were successfully isolated. In 23 of 40 patients, cavotricuspid ablation was also performed with bidirectional block obtained. At 1-year follow-up, 34 patients (86%) and 5 patients were free from atrial arrhythmia off AADs and on AADs, respectively. CONCLUSIONS: This preliminary human experience suggests that mapping and ablation of AFL and AF using this novel robotic catheter with remote control system is feasible with similar results to conventional approach.