Increased risk of atrial fibrillation in patients with psoriasis: A meta-analysis of observational studies.

BACKGROUND: Several epidemiological studies have shown that psoriasis increases the risk of developing atrial fibrillation but evidence of this is still scarce. AIMS: Our objective was to systematically review, synthesise and critique the epidemiological studies that provided information about the relationship between psoriasis and atrial fibrillation risk. METHODS: We searched through PubMed, EMBASE and the bibliographies for articles published between 1 January 2000, and 1 November 2017, that reported on the association between psoriasis and atrial fibrillation. All abstracts, full-text articles and sources were reviewed with duplicate data excluded. Summary relative risks (RRs) with 95% CI were pooled using a random effects model. RESULTS: We identified 252 articles, of these eight unique abstracts underwent full-text review. We finally selected six out of these eight studies comprising 11,187 atrial fibrillation patients. The overall pooled relative risk (RR) of atrial fibrillation was 1.39 (95% CI: 1.257-1.523, P < 0.0001) with significant heterogeneity (I2 = 80.316, Q = 45.723, τ2 = 0.017, P < 0.0001) for the random effects model. In subgroup analysis, the greater risk was found in studies from North America, RR 1.482 (95% CI: 1.119-1.964, P < 0.05), whereas a moderate risk was observed in studies from Europe RR 1.43 (95% CI: 1.269-1.628, P < 0.0001). LIMITATIONS: We were only able to include six studies with 11,178 atrial fibrillation patients, because only a few such studies have been published. CONCLUSION: Our results showed that psoriasis is significantly associated with an increased risk of developing atrial fibrillation. Therefore, physicians should monitor patient's physical condition on a timely basis.

Health care resource utilization and costs associated with atrial fibrillation and rural-urban disparities.

BACKGROUND: Atrial fibrillation (AF) imposes substantial health care and economic burden on health care systems and patients. Previous studies failed to examine health care resource utilization (HCRU) and costs among patients with incident AF and potential disparity with regard to geographic location. OBJECTIVES: To examine HCRU and costs among patients with incident AF compared with patients without AF and examine whether a geographic disparity exists. METHODS: This was a retrospective cohort study. We selected patients with AF and patients without AF from IBM/Watson MarketScan Research Databases 2014-2019. HCRU and costs were collected 12 months following an AF index date. We used 2-part models with bootstrapping to obtain the marginal estimates and CIs. Rural status was identified based on Metropolitan Statistical Area. We adjusted for age, sex, plan type, US region, and comorbidities. RESULTS: Among 156,732 patients with AF and 3,398,490 patients without AF, patients with AF had 9.04 (95% CI = 8.96-9.12) more outpatient visits, 0.82 (95% CI = 0.81-0.83) more emergency department (ED) visits, 0.33 (95% CI = 0.33-0.34) more inpatient admission, and $15,095 (95% CI = 14,871-15,324) higher total costs, compared with patients without AF. Among patients with AF, rural patients had 1.99 fewer (95% CI = -2.26 to -1.71) outpatient visits and 0.05 (95% CI = 0.02-0.08) more ED visits than urban patients. Overall, rural patients with AF had decreased total costs compared with urban patients (mean = $751; 95% CI = -1,227 to -228). CONCLUSIONS: Incident AF was associated with substantial burden of health care resources and an economic burden, and the burden was not equally distributed across patients in urban vs rural settings. DISCLOSURES: Dr Hansen reports grants from the National Science Foundation during the conduct of the study.

Psoriasis and risk of incident atrial fibrillation: A systematic review and meta-analysis.

BACKGROUND AND OBJECTIVES: Patients with psoriasis might have a higher risk of developing atrial fibrillation as a result of chronic inflammation. This study aimed to investigate this association by comprehensively reviewing all available evidence. METHODS: We conducted a systematic review and meta-analysis of cohort studies that reported relative risk, hazard ratio, incidence ratio or standardized incidence ratio with 95% confidence intervals comparing the risk of incident atrial fibrillation in patients with psoriasis versus participants without psoriasis. Both retrospective and prospective cohort studies were eligible. Pooled risk ratio and 95% confidence intervals were calculated using random-effect, generic inverse variance methods of DerSimonian and Laird. RESULTS: Three retrospective studies with 110,568 cases of psoriasis and 5,352,817 participants without psoriasis were included in this meta-analysis. The pooled risk ratio of subsequent development of atrial fibrillation in patients with psoriasis versus participants without psoriasis was 1.21 (95% confidence interval, 1.14-1.29). The statistical heterogeneity was low with an I2 of 29%. LIMITATIONS: Coding-based design of the primary studies that had limited accuracy. CONCLUSIONS: Our meta-analysis demonstrated a statistically significant increase in the risk of incident atrial fibrillation among patients with psoriasis.

Analysis of catheter contact force during atrial fibrillation ablation using the robotic navigation system: results from a randomized study.

PURPOSE: Contact with cardiac tissue is an important determinant of lesion efficacy during atrial fibrillation (AF) ablation. The Sensei X™ robotic navigation system (RNS) (Hansen Medical, Mountain View, CA, USA) has been validated for contact force (CF) sensing expressed in grams (g). The Thermocool® SmartTouch™ catheter enables the measurement of catheter tip CF and direction inside the heart. We aimed to investigate the catheter CF with and without RNS during pulmonary vein isolation (PVI) procedures. METHODS: Eighty patients with symptomatic AF (56 males, age 63 ± 18) were enrolled in this study. Fifty-seven patients had paroxysmal AF and 23 early persistent AF. All procedures were performed with the Thermocool® SmartTouch™ ablation catheter. Forty patients were randomized to perform PVI with the Sensei X™ RNS (group 1), while in the other 40 patients (group 2), PVI was performed without the RNS. RESULTS: AF ablation was performed successfully in all patients without complications, while contact force was kept in the established 10-40 g range. A significantly higher CF was documented on the PVs in group 1 compared to group 2. The 1-year freedom from AF recurrence was higher in group 1 compared to group 2 (90 vs. 65 %, p = 0.04). Moreover, a significant reduction of fluoroscopy time was noted in the RNS group (13 ± 10 vs. 20 ± 10 min, respectively, p = 0.05). CONCLUSIONS: The Sensei X™ RNS permits a significantly higher CF during transcatheter AF ablation with a low rate of AF recurrence at clinical follow-up.

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.

AIMS: To prospectively compare cardiac magnetic resonance late gadolinium enhancement (LGE) findings created by standard vs. robotically assisted catheter ablation lesions and correlate these with clinical outcomes. METHODS AND RESULTS: Forty paroxysmal atrial fibrillation patients (mean age 54 ± 13.8 years) undergoing first left atrial ablation were randomized to either robotic-assisted navigation (Hansen Sensei(®) X) or standard navigation. Pre-procedural, acute (24 h post-procedure) and late (beyond 3 months) scans were performed with LGE and T2W imaging sequences and percentage circumferential enhancement around the pulmonary vein (PV) antra were quantified. Baseline pre-procedural enhancements were similar in both groups. On acute imaging, mean % encirclements by LGE and T2W signal were 72% and 80% in the robotic group vs. 60% (P = 0.002) and 76%(P = 0.45) for standard ablation. On late imaging, the T2W signal resolved to baseline in both groups. Late gadolinium enhancement remained the predominant signal with 56% encirclement in the robotic group vs. 45% in the standard group (P = 0.04). At 6 months follow-up, arrhythmia-free patients had an almost similar mean LGE encirclement (robotic 64%, standard 60%, P = 0.45) but in recurrences, LGE was higher in the robotic group (43% vs. 30%, P = 0.001). At mean 3 years follow-up, 1.3 procedures were performed in the robotic group compared with 1.9 (P < 0.001) in the standard to achieve a success rate of 80% vs. 75%. CONCLUSION: Robotically assisted ablation results in greater LGE around the PV antrum. Effective lesions created through improved catheter stability and contact force during initial treatment may have a role in reducing subsequent re-do procedures.

Impact of steerable sheaths on contact forces and reconnection sites in ablation for persistent atrial fibrillation.

BACKGROUND: In preclinical studies, catheter contact force (CF) during radiofrequency ablation correlates with the subsequent lesion size. We investigated the impact of steerable sheaths on ablation CF, its consistency, and wide area circumferential ablation (WACA) line reconnection sites. METHODS AND RESULTS: Five thousand and sixty-four ablations were analyzed across 60 patients undergoing first-time ablation for persistent AF using a CF-sensing catheter: 19 manual nonsteerable sheath (Manual-NSS), 11 manual steerable sheath, and 30 robotic steerable sheath (Sensei, Hansen Medical Inc.) procedures were studied. Ablation CFs were higher in the steerable sheath groups for all left atrial ablations and also WACA ablations specifically (P < 0.006), but less consistent per WACA segment (P < 0.005). There were significant differences in the CFs around both WACAs by group: in the left WACA CFs were lower with Manual-NSS, other than at the anterior-inferior and posterior-superior regions, and lower in the right WACA, other than the anterior-superior region. There was a difference in the proportion of segments chronically reconnecting across groups: Manual-NSS 26.5%, manual steerable sheath 4.6%, robotic 12% (P < 0.0005). The left atrial appendage/PV ridge and right posterior wall were common sites of reconnection in all groups. CONCLUSIONS: Steerable sheaths increased ablation CF; however, there were region-specific heterogeneities in the extent of increment, with some segments where they failed to increase CF. Steerable sheath use was associated with reduced WACA-segment reconnection. It may be that the benefits of steerable sheath use in terms of higher CFs could be translated to improved clinical outcomes if regional weaknesses of this technology are taken into account during ablation procedures.

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/cm(2)) ECI value was 99 ± 13, whereas ECI values in a noncontact site (0 g/cm(2)) and in a light contact site (1-10 g/cm(2)) 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.

Worldwide experience with the robotic navigation system in catheter ablation of atrial fibrillation: methodology, efficacy and safety.

INTRODUCTION: The Hansen Robotic system has been utilized in ablation procedures for atrial fibrillation (AF). However, because of the lack of tactile feedback and the rigidity of the robotic sheath, this approach could result in higher risk of complications. This worldwide survey reports a multicenter experience on the methodology, efficacy, and safety of the Hansen system in AF ablations. METHODS AND RESULTS: A questionnaire addressing questions on patient's demographics, procedural parameters, ablation success rate and safety information was sent to all centers where more than 50 robotic AF ablation cases have been performed. From June 2007 to December 2009, 1,728 procedures were performed at 12 centers utilizing the Hansen robotic navigation technology. The overall complication rate was 4.7% and the success rate was 67.1% after 18 ± 4 months of follow-up. In 5 low volume centers there appeared to be a learning curve of about 50 cases (complication rate 11.2% for the first 50 cases vs 3.7% for the 51-100 cases; P = 0.044) and a trend showing a decrease of complication rate with increasing case volume. However, in the remaining 7 centers no learning curve was present and the complication rate was stable over time (3.7% for the first 50 cases vs 3.6% for the 51st case thereafter; P = 0.942). CONCLUSION: The Hansen robotic system can be used for AF ablation safely. In low volume centers, there appeared to be a learning curve of the first 50 cases after which the complication rate decreased. With a higher case volume, the success rate increased.

Improved electrogram attenuation during ablation of paroxysmal atrial fibrillation with the Hansen robotic system.

BACKGROUND: Robotic catheter ablation aims to improve outcomes after ablation of atrial fibrillation (AF) through improved lesion quality. This study examined electrogram attenuation as a measure of efficacy in response to robotic (ROB) and manual (MAN) ablation. METHODS: Patients with paroxysmal AF undergoing ablation as part of an ongoing randomized controlled trial were studied (Clinical Trials Registration NCT01037296). Patients underwent pulmonary vein isolation using NavX (St. Jude Medical, St. Paul, MN, USA). Patients were randomized to MAN or ROB catheter ablation using a 3.5-mm irrigated-tip catheter with standardized ablation settings. Bipolar electrogram voltage was measured at 0, 5, 10, 20, and 30 seconds after ablation onset. Distance from ablation lesion to the left atrial surface on NavX were calculated. RESULTS: Similar ablation energy was delivered in ROB and MAN groups, achieving comparable rates of PV isolation (100% vs 98%). The bipolar voltages of 4,434 electrograms from 303 ablation lesions (146 ROB, 157 MAN) were measured. At 30 seconds, signal attenuation was greater in the ROB group than MAN (mean 65 ± 4% vs 55 ± 4% of baseline voltage, P < 0.01). A total of 2,064 NavX ablation lesions were assessed (906 ROB and 1,158 MAN). ROB lesions were on average 0.52 mm further inside the geometry than MAN (P < 0.0001). CONCLUSIONS: Robotic ablation results in greater signal attenuation in man. This is achieved despite manual lesions being closer to the left atrial surface. Catheter stability and constant energy delivery may be key to achieving signal attenuation, rather than increased contact force.

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.

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

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.

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.

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.

Experience with the hansen robotic system for atrial fibrillation ablation--lessons learned and techniques modified: Hansen in the real world.

INTRODUCTION: The Hansen robotic system has only recently been used in the United States for catheter ablation procedures in humans. Atrial fibrillation (AF) ablation may be performed utilizing this system. We report our management of complications with early experience of this system. METHODS AND RESULTS: All 71 patients in whom the system was utilized were included. In all patients, a 2-operator technique was to be employed; one operator manipulates the ablation catheter via the robot and the other manipulates the circular mapping and intracardiac echocardiogram catheters. There was no procedure-related mortality. All vascular complications occurred in the first 25 procedures performed. There were 6 intraoperative procedural-related complications. These included significant vascular complications (n = 4), one of whom required iliac vein stenting, and 2 cardiac tamponade (one related to a pop-phenomenon)-successfully treated by pericardiocentesis. Early complications (n = 3) were 1 tamponade several hours post-procedure, 1 vascular complication, and 1 pericarditis. Late complications included 5 patients with severe pulmonary vein stenosis (all in first 27 patients) and 1 patient with gastroparesis. All complications were successfully managed without persistent morbidity and occurred earlier in our experience. This led to specific alterations in our vascular access and ablation techniques. These include the use of a longer 14 Fr sheath, through which the robotic sheath is more safely advanced. The choice of ablation catheter and titration of power, particularly when the catheter has a perpendicular orientation to the atrial wall, is also important. CONCLUSIONS: The suggested modifications may make the system easier to use with the potential to reduce complications.

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.