Developing an action plan for patient radiation safety in adult cardiovascular medicine. Proceedings from the Duke University Clinical Research Institute/American College of Cardiology Foundation/American Heart Association Think Tank Held on February 28, 2011.

Technological advances and increased utilization of medical testing and procedures have prompted greater attention to ensuring the patient safety of radiation use in the practice of adult cardiovascular medicine. In response, representatives from cardiovascular imaging societies, private payers, government and nongovernmental agencies, industry, medical physicists, and patient representatives met to develop goals and strategies toward this end; this report provides an overview of the discussions. This expert "think tank" reached consensus on several broad directions including: the need for broad collaboration across a large number of diverse stakeholders; clarification of the relationship between medical radiation and stochastic events; required education of ordering and providing physicians, and creation of a culture of safety; development of infrastructure to support robust dose assessment and longitudinal tracking; continued close attention to patient selection by balancing the benefit of cardiovascular testing and procedures against carefully minimized radiation exposures; collation, dissemination, and implementation of best practices; and robust education, not only across the healthcare community but also to patients, the public, and media. Finally, because patient radiation safety in cardiovascular imaging is complex, any proposed actions need to be carefully vetted (and monitored) for possible unintended consequences.

Developing an action plan for patient radiation safety in adult cardiovascular medicine: proceedings from the Duke University Clinical Research Institute/American College of Cardiology Foundation/American Heart Association think tank held on February 28, 2011.

Technological advances and increased utilization of medical testing and procedures have prompted greater attention to ensuring the patient safety of radiation use in the practice of adult cardiovascular medicine. In response, representatives from cardiovascular imaging societies, private payers, government and nongovernmental agencies, industry, medical physicists, and patient representatives met to develop goals and strategies toward this end; this report provides an overview of the discussions. This expert "think tank" reached consensus on several broad directions including: the need for broad collaboration across a large number of diverse stakeholders; clarification of the relationship between medical radiation and stochastic events; required education of ordering and providing physicians, and creation of a culture of safety; development of infrastructure to support robust dose assessment and longitudinal tracking; continued close attention to patient selection by balancing the benefit of cardiovascular testing and procedures against carefully minimized radiation exposures; collation, dissemination, and implementation of best practices; and robust education, not only across the healthcare community, but also to patients, the public, and media. Finally, because patient radiation safety in cardiovascular imaging is complex, any proposed actions need to be carefully vetted (and monitored) for possible unintended consequences.

Developing an action plan for patient radiation safety in adult cardiovascular medicine: proceedings from the Duke University Clinical Research Institute/American College of Cardiology Foundation/American Heart Association Think Tank held on February 28, 2011.

Technological advances and increased utilization of medical testing and procedures have prompted greater attention to ensuring the patient safety of radiation use in the practice of adult cardiovascular medicine. In response, representatives from cardiovascular imaging societies, private payers, government and nongovernmental agencies, industry, medical physicists, and patient representatives met to develop goals and strategies toward this end; this report provides an overview of the discussions. This expert "think tank" reached consensus on several broad directions including: the need for broad collaboration across a large number of diverse stakeholders; clarification of the relationship between medical radiation and stochastic events; required education of ordering and providing physicians, and creation of a culture of safety; development of infrastructure to support robust dose assessment and longitudinal tracking; continued close attention to patient selection by balancing the benefit of cardiovascular testing and procedures against carefully minimized radiation exposures; collation, dissemination, and implementation of best practices; and robust education, not only across the healthcare community, but also to patients, the public, and media. Finally, because patient radiation safety in cardiovascular imaging is complex, any proposed actions need to be carefully vetted (and monitored) for possible unintended consequences.

Safety and efficacy of pulmonary vein antral isolation in patients with obstructive sleep apnea: the impact of continuous positive airway pressure.

BACKGROUND: Obstructive sleep apnea (OSA) may be associated with pulmonary vein antrum isolation (PVAI) failure. The aim of the present study was to investigate if treatment with continuous positive airway pressure (CPAP) improved PVAI success rates. METHODS AND RESULTS: From January 2004 to December 2007, 3000 consecutive patients underwent PVAI. Patients were screened for OSA and CPAP use. Six hundred forty (21.3%) patients had OSA. Patients with OSA had more procedural failures (P=0.024) and hematomas (P<0.001). Eight percent of the non-OSA paroxysmal atrial fibrillation patients had nonpulmonary vein antrum triggers (non-PV triggers) and posterior wall firing versus 20% of the OSA group (P<0.001). Nineteen percent of the non-OSA nonparoxysmal atrial fibrillation population had non-PV triggers versus 31% in the OSA group (P=0.001). At the end of the follow-up period (32±14 months), 79% of the non-CPAP and 68% of the CPAP group were free of atrial fibrillation (P=0.003). Not using CPAP in addition to having non-PV triggers strongly predicted procedural failure (hazard ratio, 8.81; P<0.001). CONCLUSIONS: OSA was an independent predictor for PVAI failure. Treatment with CPAP improved PVAI success rates. Patients not treated with CPAP in addition to having higher prevalence of non-PV triggers were 8 times more likely to fail the procedure.

Left atrial appendage: an underrecognized trigger site of atrial fibrillation.

BACKGROUND: Together with pulmonary veins, many extrapulmonary vein areas may be the source of initiation and maintenance of atrial fibrillation. The left atrial appendage (LAA) is an underestimated site of initiation of atrial fibrillation. Here, we report the prevalence of triggers from the LAA and the best strategy for successful ablation. METHODS AND RESULTS: Nine hundred eighty-seven consecutive patients (29% paroxysmal, 71% nonparoxysmal) undergoing redo catheter ablation for atrial fibrillation were enrolled. Two hundred sixty-six patients (27%) showed firing from the LAA and became the study population. In 86 of 987 patients (8.7%; 5 paroxysmal, 81 nonparoxysmal), the LAA was found to be the only source of arrhythmia with no pulmonary veins or other extrapulmonary vein site reconnection. Ablation was performed either with focal lesion (n=56; group 2) or to achieve LAA isolation by placement of the circular catheter at the ostium of the LAA guided by intracardiac echocardiography (167 patients; group 3). In the remaining patients, LAA firing was not ablated (n=43; group 1). At the 12+/-3-month follow-up, 32 patients (74%) in group 1 had recurrence compared with 38 (68%) in group 2 and 25 (15%) in group 3 (P<0.001). CONCLUSIONS: The LAA appears to be responsible for arrhythmias in 27% of patients presenting for repeat procedures. Isolation of the LAA could achieve freedom from atrial fibrillation in patients presenting for a repeat procedure when arrhythmias initiating from this structure are demonstrated.

Periprocedural stroke and management of major bleeding complications in patients undergoing catheter ablation of atrial fibrillation: the impact of periprocedural therapeutic international normalized ratio.

BACKGROUND: Catheter ablation of atrial fibrillation is associated with the potential risk of periprocedural stroke, which can range between 1% and 5%. We developed a prospective database to evaluate the prevalence of stroke over time and to assess whether the periprocedural anticoagulation strategy and use of open irrigation ablation catheter have resulted in a reduction of this complication. METHODS AND RESULTS: We collected data from 9 centers performing the same ablation procedure with the same anticoagulation protocol. We divided the patients into 3 groups: ablation with an 8-mm catheter off warfarin (group 1), ablation with an open irrigated catheter off warfarin (group 2), and ablation with an open irrigated catheter on warfarin (group 3). Outcome data on stroke/transient ischemic attack and bleeding complications during and early after the procedures were collected. Of 6454 consecutive patients in the study, 2488 were in group 1, 1348 were in group 2, and 2618 were in group 3. Periprocedural stroke/transient ischemic attack occurred in 27 patients (1.1%) in group 1 and 12 patients (0.9%) in group 2. Despite a higher prevalence of nonparoxysmal atrial fibrillation and more patients with CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score >2, no stroke/transient ischemic attack was reported in group 3. Complications among groups 1, 2, and 3, including major bleeding (10 [0.4%], 11 [0.8%], and 10 [0.4%], respectively; P>0.05) and pericardial effusion (11 [0.4%], 11 [0.8%], and 12 [0.5%]; P>0.05), were equally distributed. CONCLUSIONS: The combination of an open irrigation ablation catheter and periprocedural therapeutic anticoagulation with warfarin may reduce the risk of periprocedural stroke without increasing the risk of pericardial effusion or other bleeding complications.

Esophageal capsule endoscopy after radiofrequency catheter ablation for atrial fibrillation: documented higher risk of luminal esophageal damage with general anesthesia as compared with conscious sedation.

BACKGROUND: Left atrioesophageal fistula is a rare but devastating complication that may occur after catheter ablation of atrial fibrillation. We used capsule endoscopy to assess esophageal injury after catheter ablation for atrial fibrillation in a population randomized to undergo general anesthesia or conscious sedation. METHODS AND RESULTS: Fifty patients undergoing atrial fibrillation ablation for paroxysmal symptomatic atrial fibrillation refractory to antiarrhythmic drugs were enrolled and randomized, including those undergoing the procedure under general anesthesia (25 patients, group 1) and those receiving conscious sedation with fentanyl or midazolam (25 patients, group 2). All patients underwent esophageal temperature monitoring during the procedure. The day after ablation, all patients had capsule endoscopy to assess the presence of endoluminal tissue damage of the esophagus. We observed esophageal tissue damage in 12 (48%) patients of group 1 and 1 esophageal tissue damage in a single patient (4%) of group 2 (P<0.001). The maximal esophageal temperature was significantly higher in patients undergoing general anesthesia (group 1) versus patients undergoing conscious sedation (group 2) (40.6+/-1 degrees C versus 39.6+/-0.8 degrees C; P< 0.003). The time to peak temperature was 9+/-7 seconds in group 1 and 21+/-9 seconds in group 2, and this difference was statistically significant (P<0.001). No complication occurred during or after the administration of the pill cam or during the procedures. All esophageal lesions normalized at the 2-month repeat endoscopic examination. CONCLUSIONS: The use of general anesthesia increases the risk of esophageal damage detected by capsule endoscopy.

Impact of type of atrial fibrillation and repeat catheter ablation on long-term freedom from atrial fibrillation: results from a multicenter study.

BACKGROUND/OBJECTIVE: The purpose of this prospective multicenter study was to compare results of catheter ablation in patients with paroxysmal atrial fibrillation (PAF) and those with nonparoxysmal atrial fibrillation (NPAF). The impact and the role of repeat catheter ablation were assessed in patients with recurrence. METHODS/RESULTS: One thousand four hundred four patients underwent catheter ablation for atrial fibrillation (AF) performed by 12 operators at four institutions using a single technique guided by intracardiac echocardiography. Of these patients, 728 had PAF and 676 had NPAF. Among the NPAF patients, 293 had persistent AF and 383 had long-standing persistent AF. Patients with NPAF had a higher incidence of hypertension and/or structural heart disease (64.8% vs 48.5%, P = .003) and a lower mean left ventricular ejection fraction (53.3% +/- 8.7% vs 55.7 +/- 6.5%, P <.001). All patients underwent antral isolation of all four pulmonary veins and the superior vena cava. At mean follow-up of 57 +/- 17 months, 565 of 728 patients with PAF and 454 of 676 patients with NPAF (77.6% vs 67.2%, P <.001) had freedom from AF after a single ablation procedure. For arrhythmia recurrences, 74.2% (121/163) patients with PAF and 74.8% (166/222) with NPAF underwent repeat ablation, after which 92.4% patients with PAF and 84.0% patients with NPAF remained free from AF. CONCLUSION: Pulmonary vein antrum isolation guided by intracardiac echocardiography results in significant freedom from AF, even when performed by multiple operators in different centers. At least moderate efficacy can be achieved in patients with NPAF, although the success rate is lower than in patients with PAF. Considerably higher success can be achieved in both groups with repeat ablation.

Ablation of atrial fibrillation: what can we tell our patients?

Although catheter-based radiofrequency ablation is no longer experimental, it is not yet the first-line treatment for most patients. The authors describe how this procedure works, its indications, benefits, and limitations, and important points to communicate to potential candidates for this procedure.

Prevention of phrenic nerve injury during epicardial ablation: comparison of methods for separating the phrenic nerve from the epicardial surface.

BACKGROUND: The proximity of the phrenic nerve (PN) to cardiac tissue relevant to arrhythmias may increase the risk of PN injury. Strategies for preventing PN injury in the pericardial space are limited. OBJECTIVE: The purpose of this study was to compare methods for separating the PN from the epicardial surface in order to prevent PN injury. METHODS: Eight patients referred for epicardial ablation of arrhythmias were enrolled in the study. All patients required ablation near the PN. Endocardial and epicardial access was obtained in all patients. A three-dimensional mapping system was used to guide mapping and ablation. All patients underwent epicardial catheter ablation. Pacing via the ablation catheter identified the location of the PN. In order to prevent PN injury, four new strategies were tested in each patient. We sought to increase the distance between the epicardium and the PN by (1) placing a large-diameter balloon between the nerve and the myocardium, (2) introducing saline in steps of 20 ml until PN capture was lost or blood pressure dropped below 60 mmHg, (3) introducing air until PN capture was lost or blood pressure dropped below 60 mmHg, or (4) introducing a combination of saline and air until PN capture was lost or blood pressure dropped below 60 mmHg. RESULTS: At each step, epicardial pacing was performed to assess for PN stimulation. The combination of air and saline resulted in the greatest decrease of PN stimulation. Saline only failed in all cases. Air only and balloon placement were infrequently successful. CONCLUSION: Controlled and progressive inflation of air and saline together with careful monitoring of hemodynamic parameters appears to be the best strategy for preventing PN injury during epicardial ablation. Placement of a large balloon in the appropriate location can be difficult.

Relationship between catheter forces, lesion characteristics, "popping," and char formation: experience with robotic navigation system.

INTRODUCTION: Popping, char and perforation are complications that can occur following catheter ablation. We measured the amount of grams (g) applied to the endocardium during ablation using a sensor incorporated in the long sheath of a robotic system. We evaluated the relationship between lesion formation, pressure, and the development of complications. METHODS: Using a robotic navigation system, lesions were placed in the left atrium (LA) at six settings, using a constant duration (40 seconds) and flow rate of either 17 cc/min or 30 cc/min with an open irrigated catheter (OIC). Evidence of complications was noted and lesion location recorded for later analysis at necropsy. RESULTS: Lesions using 30 Watts (W) were more likely to be transmural at higher (>40 g) than lower (<30 g) pressures (75% vs 25%, P < 0.001). Significantly higher number of lesions using >40 g of pressure demonstrated "popping" and crater formation as compared with lesions with 20-30 g of pressure (41% vs 15%, P = 0.008). A majority of lesions placed using higher power (45 W) with higher pressures (>40 g) were associated with char and crater formation (66.7%). No lesions using 10 g of pressure were transmural, regardless of the power. Lesions placed with a power setting less than 35 W were more likely to result in "relative" sparing of the endocardial surface than lesions at a power setting higher than 35 W (62% vs 33.3%, P = 0.02) regardless of the pressure. CONCLUSIONS: When using an OIC, lower power settings (

Intracardiac alternans compared to surface T-wave alternans as a predictor of ventricular arrhythmias in humans.

BACKGROUND: Microvolt T-wave alternans (MTWA) measured from the surface electrocardiogram (ECG) is a marker of sudden cardiac death (SCD). Recently, it has been suggested that intracardiac alternans (ICA) detected from the endocardium underlies MTWA and is a marker of electrical instability leading to ventricular arrhythmias. As such, ICA may be used in future implantable cardioverter-defibrillators (ICDs) to monitor periods of electrical instability before ICD therapy. We examined whether electrical instability, as measured by MTWA, can be detected by ICA located from the right ventricle and if ICA can predict ventricular arrhythmias in patients with ICDs. METHODS: Both MTWA and ICA were measured simultaneously during atrial pacing in 68 patients undergoing electrophysiology study (EPS). ICA was measured from unipolar electrograms acquired from a catheter at the apical, mid, and basal regions of the right ventricle in 48 patients and at the apical region alone in 20 patients. Indications for EPS included nonsustained ventricular tachycardia, cardiomyopathy, syncope, near syncope, or palpitation. RESULTS: Fifty-six of 68 patients had cardiomyopathy with left ventricular ejection fraction (LVEF)

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.

Esophageal luminal temperature measurement underestimates esophageal tissue temperature during radiofrequency ablation within the canine left atrium: comparison between 8 mm tip and open irrigation catheters.

INTRODUCTION: Evaluation of luminal temperature during left atrial ablation is used clinically; however, luminal temperature does not necessarily reflect temperature within the esophageal wall and poses a risk of atrioesophageal fistula. This animal study evaluates luminal esophageal temperature and its relation to the temperature of the external esophageal tissue during left atrial lesions using the 8 mm solid tip and the open irrigated tip catheters (OIC). METHODS AND RESULTS: A thermocouple was secured to the external surface of the esophagus at the level of the left atrium of the dogs. Luminal esophageal temperature was measured using a standard temperature probe. In four randomized dogs, lesions were placed using an 8 mm solid tip ablation catheter. In six randomized dogs, lesions were placed using the 3.5 mm OIC. The average peak esophageal tissue temperature when using the OIC was significantly higher than that of the 8 mm tip catheter (88.6 degrees C +/- 15.0 degrees C vs. 62.3 degrees C +/- 12.5 degrees C, P < 0.05). Both OIC and 8 mm tip catheter had significantly higher peak tissue temperatures than luminal temperatures (OIC: 88.6 degrees C +/- 15.0 degrees C vs 39.7 degrees C +/- 0.82 degrees C, P < 0.05) (8 mm: 62.3 degrees C +/- 12.5 degrees C vs 39.0 +/- 0.5 degrees C, P < 0.05). Both catheters achieved peak temperatures faster in the tissue as compared to the lumen of the esophagus, although the tissue temperature peaked significantly faster for the OIC (OIC: 25 seconds vs 90 seconds, P < 0.05) (8 mm: 63 seconds vs 105 seconds, P < 0.05). CONCLUSION: Despite the significant difference in actual tissue temperatures, no significant difference was observed in luminal temperatures between the OIC and 8 mm tip catheter.

Efficacy, safety, and outcome of atrial fibrillation ablation in septuagenarians.

AIMS: Catheter ablation is an effective treatment for atrial fibrillation (AF). The outcome of AF ablation in septuagenarians is not clear. Our aim was to evaluate success rate, outcome, and complication rate of AF ablation in septuagenarians. METHODS AND RESULTS: We collected data from 174 consecutive patients over 75 years of age who underwent AF ablation from 2001 to 2006. AF was paroxysmal in 55%. High-risk CHADS score (>or=2) was present in 65% of the population. Over a mean follow-up of 20 +/- 14 months, 127 (73%) maintained sinus rhythm (SR) with a single procedure, whereas 47 patients had recurrence of AF. Twenty of them had a second ablation, successful in 16 (80%). Major acute complications included one CVA and one hemothorax (2/194 [1.0%]). During the follow-up, three patients had a CVA within the first 6 weeks after ablation. Warfarin was discontinued in 138 out 143 patients (96%) who maintained SR without AADs with no embolic event occurring over a mean follow-up of 16 +/- 12 months. CONCLUSION: AF ablation is a safe and effective treatment for AF in septuagenarians.

Vagal responses induced by endocardial left atrial autonomic ganglion stimulation before and after pulmonary vein antrum isolation for atrial fibrillation.

BACKGROUND: Elimination of vagal inputs into the left atrium (LA) may be necessary for successful catheter ablation of atrial fibrillation (AF). These vagal inputs are clustered in autonomic ganglia (AG) that are close to the pulmonary vein antrum (PVA) borders, but whether standard intracardiac echocardiography (ICE)-guided PVA isolation (PVAI) affects these inputs is unknown. OBJECTIVE: The purpose of this study was to assess whether standard ICE-guided PVAI affects vagal responses induced by endocardial AG stimulation in the LA. METHODS: Twenty consecutive patients undergoing first-time PVAI (group 1) and 20 consecutive patients undergoing repeat PVAI for AF recurrence (group 2) were enrolled in the study. Before ablation, electrical stimulation (20 Hz, pulse duration 10 ms, voltage range 12-20 V) was performed through an 8-mm-tip ablation catheter. Based on prior data, regions around all four PVA borders were carefully mapped and stimulated to localize AG inputs. A positive stimulated vagal response was defined as atrioventricular (AV) block, asystole, or increase in mean RR interval by >50%. Locations of positive vagal responses were recorded wth biplane fluoroscopy and CARTO. All patients then underwent standard ICE-guided PVAI by an operator blinded to the locations of vagal responses. Stimulation of the AG locations was then repeated postablation. RESULTS: Patients (age 54 +/- 11 years, 30% female, ejection fraction 54% +/- 7%) had a history of paroxysmal (75%) and persistent (25%) AF. In group 1, vagal responses were induced in all 20 patients around a mean of 3.8 +/- 0.4 PVAs per patient. The most common response was asystole (53%), mean RR slowing >50% (28%), and AV block (20%). Postablation, vagal responses could no longer be induced in all 20 patients. A diminished response was induced (RR slowing <50%) in 2/20 patients around one PVA each. In group 2, vagal responses were not induced in any of the 20 repeat patients. Stimulation capture postablation was confirmed because transient, nonsustained (<30 seconds) AF or atrial flutter was induced in all 40 patients with stimulation, whether vagal responses were induced or not. CONCLUSIONS: Standard ICE-guided PVAI eliminates vagal responses induced by AG stimulation. Responses are not seen in patients presenting for repeat PVAI, despite clinical recurrence of AF.

Remote magnetic navigation: human experience in pulmonary vein ablation.

OBJECTIVES: We aimed at assessing the feasibility and efficacy of remote magnetic navigation (MN) and ablation in patients with atrial fibrillation (AF). BACKGROUND: This novel MN system could facilitate standardization of the procedures, reducing the importance of the operator skill. METHODS: After becoming familiar with the system in 48 previous patients, 45 consecutive patients with AF were considered for ablation using the Niobe II remote magnetic system (Stereotaxis, St. Louis, Missouri) in a stepwise approach: circumferential pulmonary vein ablation (CPVA), pulmonary vein antrum isolation (PVAI), and, if failed, PVAI using the conventional approach. Remote navigation was done using the coordinate or the wand approach. Ablation end point was electrical disconnection of the pulmonary veins (PVs). RESULTS: Using the coordinate approach, the target location was reached in only 60% of the sites, whereas by using the wand approach 100% of the sites could be reached. After step 2 ablation, only 1 PV in 4 patients (8%) could be electrically isolated. Charring on the ablation catheter tip was seen in 15 (33%) of the cases. In 23 patients, all PVs were isolated with the conventional thermocool catheter, and in 22 patients only the right PVs were isolated with the conventional catheter. After a mean follow-up period of 11 +/- 2 months, recurrence was seen in 5 patients (22%) with complete PVAI and in 20 patients (90%) with incomplete PVAI. CONCLUSIONS: Remote navigation using a magnetic system is a feasible technique. With the present catheter technology, effective lesions cannot be achieved in most cases. This appears to impact the cure rate of AF patients.

Pulmonary vein antral isolation using an open irrigation ablation catheter for the treatment of atrial fibrillation: a randomized pilot study.

OBJECTIVES: We sought to test how catheter ablation using an open irrigation catheter (OIC) compares with standard catheters for pulmonary vein antrum isolation. BACKGROUND: Open irrigation catheters have the advantage of delivering greater power without increasing the temperature of the catheter tip, which enables deeper and wider lesions without the formation of coagulum on catheters. METHODS: Catheter ablation was performed using an 8-mm catheter (8MC) or an OIC. Patients were randomized to 3 groups: 8MC; OIC-1, OIC with a higher peak power (50 W); and OIC-2, OIC with lower peak power (35 W). RESULTS: A total of 180 patients were randomized to the 3 treatment strategies. Isolation of pulmonary vein antra was achieved in all patients. The freedom from atrial fibrillation was significantly greater in the 8MC and OIC-1 groups compared with the OIC-2 group (78%, 82%, and 68%, respectively, p = 0.043). Fluoroscopy time was lower in OIC-1 compared with OIC-2 and 8MC (28 +/- 1 min, 53 +/- 2 min, and 46 +/- 2 min, respectively, p = 0.001). The mean left atrium instrumentation time was lower in the OIC-1 compared with the OIC-2 and 8MC groups (59 +/- 3 min, 90 +/- 5 min, and 88 +/- 4 min, respectively, p = 0.001). However, there was a greater incidence of "pops" in the OIC-1 (100%, 0%, 0%, p < 0.001) along with higher incidences of pericardial effusion (20%, 0%, 0%, p < 0.001) and gastrointestinal complaints (17% in OIC-1, 3% in 8MC, and 5% in OIC-2, p = 0.031). CONCLUSIONS: Although there was a decrease in fluoroscopy and left atrium instrumentation time with the use of OIC at higher power, this setting was associated with increased cardiovascular and gastrointestinal complications.