Tristram Bahnson - Academia.edu (original) (raw)
Papers by Tristram Bahnson
Heart rhythm, Apr 1, 2018
Compared with men, women have longer corrected QT (QTc) intervals, lower clearance of dofetilide,... more Compared with men, women have longer corrected QT (QTc) intervals, lower clearance of dofetilide, and higher rates of drug-induced torsades de pointes, but the dofetilide dosing algorithm is the same for men and women. The purpose of this study was to evaluate the tolerability of the 500 μg twice daily dose of dofetilide for men and women. Men and women admitted to Duke University Medical Center (January 1, 2006, to October 19, 2012) for the initiation of dofetilide 500 μg twice daily were matched 1:1 on age and estimated creatinine clearance. Electrocardiograms throughout dosing were analyzed, and rates of dofetilide discontinuations and dose reductions were compared in unadjusted and adjusted analyses. For 220 matched men and women, the median age was 62.5 years (interquartile range 55-69 years) and the median eCrCl was 98.1 mL/min (interquartile range 77.6-126.2 mL/min). Women were less likely than men to have hypertension and interventricular conduction delay but were otherwise ...
Heart rhythm, Sep 14, 2017
Atrioesophageal fistula formation is a rare but life-threatening complication of AF ablation. Con... more Atrioesophageal fistula formation is a rare but life-threatening complication of AF ablation. Contact force (CF) sensing catheters improve procedural effectiveness. However, the impact of the implementation of CF-sensing technology on risk of atrioesophageal fistula formation has not been explored. To determine the association between the use of CF sensing catheters and atrioesophageal fistula development METHODS: We searched the Manufacturer and User Facility Device Experience (MAUDE) database for adverse event reports involving FDA approved ablation catheters. Among 2689 device reports, we identified 78 atrioesophageal fistula cases, 65 of which involved CF-sensing catheters and 13 non-CF sensing catheters. The percentage of total reports involving atrioeosphageal fistula was 5.4% (65/1202) for CF sensing and 0.9% (13/1487) for non-CF sensing catheters (p< 0.0001). Procedural details (CF and power settings) were not consistently reported. Esophageal temperature increases were d...
Pacing and Clinical Electrophysiology, 2017
Symptomatic sinus node dysfunction (SND) consists of a variety of manifestations, including tachy... more Symptomatic sinus node dysfunction (SND) consists of a variety of manifestations, including tachycardia-bradycardia syndrome. Atrial fibrillation (AF) is commonly associated with SND, which complicates the management of both conditions. This paper reviews the epidemiology, pathophysiology, and clinical trial data investigating therapeutic approaches for treatment of patients with both SND and AF. The authors reviewed articles published in English describing the epidemiology, pathophysiology, and therapeutic approaches for patients with SND and AF. The search was conducted using PubMed. Keywords included: sick sinus syndrome, sinus node dysfunction, atrial fibrillation, pacing, and pulmonary vein isolation. SND affects up to one in five patients with AF. AF can lead to anatomical and electrophysiological remodeling in both atria, including the region of sinoatrial node. Changes including atrial fibrosis, altered calcium channel metabolism, and transformed gene expression have been demonstrated in patients with AF and SND. Nonrandomized clinical trial data have failed to demonstrate whether any pacing strategy can reduce the risk of AF. Pulmonary vein isolation appears to decrease episodes of tachybrady syndrome and sinus pauses. SND affects up to one in five patients with AF. The pathophysiological derangements in gene expression, ion channel metabolism, and alterations in myocardial architecture associated with AF may lead to anatomic and electrical changes in the region of the sinoatrial node. Ablation may improve symptoms associated with SND in patients with AF. Future randomized trials are needed to clarify the epidemiology and optimal management of patients with SND and AF.
The American Journal of Cardiology, 2017
The utility of routine transesophageal echocardiography (TEE) to exclude left atrial appendage (L... more The utility of routine transesophageal echocardiography (TEE) to exclude left atrial appendage (LAA) thrombus before atrial fibrillation (AF) ablation in patients treated with nonvitamin K oral anticoagulant (NOAC) therapy is unclear. This single-center retrospective study sought to investigate the incidence of LAA thrombus in patients undergoing routine TEE before AF ablation treated with warfarin or NOAC therapy. We included 937 routine pre-AF ablation TEE procedures performed in patients treated with warfarin (n = 517) or NOAC (n = 420). Patients were anticoagulated without interruption for at least 4 consecutive weeks before the TEE. Patients treated with warfarin had lower LAA velocity and underwent TEE earlier in the study period than those treated with NOAC (p &amp;amp;amp;amp;amp;amp;amp;lt;0.05). The incidence of LAA thrombus was higher in patients treated with warfarin (1.55%, 8 of 517) compared with patients treated with NOAC (0.24%, 1 of 420, p = 0.0473 for difference). No LAA thrombus was identified in NOAC-treated patients with a CHA2DS2-VASC score &amp;amp;amp;amp;amp;amp;amp;lt;5 and in warfarin-treated patients with a CHA2DS2-VASC score &amp;amp;amp;amp;amp;amp;amp;lt;2. TEE-related complications occurred in 3 of 937 procedures (0.3%). In conclusion, LAA thrombus is detected rarely during pre-AF ablation TEE. Treatment with an NOAC is associated with a lower incidence of pre-AF ablation LAA thrombus compared with warfarin.
Journal of Cardiovascular Electrophysiology, 2016
Percutaneous catheter ablation for atrial fibrillation (AF) is a proven treatment strategy, but i... more Percutaneous catheter ablation for atrial fibrillation (AF) is a proven treatment strategy, but its modest long-term efficacy suggests further research is needed to guide selection of optimal, patient-specific ablation approaches. It is widely believed that pulmonary vein (PV) isolation is a critical component of catheter ablation for AF,1,2 as evidenced by the frequent finding of PV reconnection during repeat ablation procedures in cases of arrhythmia recurrence.3,4 Durable electrical isolation of the PVs using percutaneous endocardial radiofrequency ablation (RFA) requires delivery of circumferential, contiguous, and transmural lesions encompassing the PV antra. Although acute (intraprocedural) electrical isolation is ensured by demonstration of conduction block, high rates of PV reconnection are found across studies. Unrecognized gaps or nontransmural lesions in the initially delivered ablation lines have been suggested as culprits for this common occurrence,5 highlighting the need for improved methods to guide lesion delivery and assessment. Other factors such as reverse remodeling after restoration of sinus rhythm6 or a dynamic safety factor for conduction relating to nonhomogenous injury at ablation sites7,8 could also account for late PV reconnection. Given the importance of achieving durable PV isolation during an index procedure, a primary task for operators performing therapeutic ablation for AF is to devise and utilize strategies to more reliably deliver contiguous, transmural lesions at the PV antra, and/or to more accurately identify regions of incomplete ablation recommending additional lesion delivery. Radiofrequency (RF) energy delivery is the preeminent ablation modality, and is widely used for curative percutaneous catheter based treatment of supraventricular arrhythmias including AF. Early studies identified changes in the impedance of the ablation circuit (between the endocardial catheter tip and cutaneous grounding patch) during RF energy delivery as indicative of tissue heating, the degree of catheter tip contact, and lesion formation. This led to impedance monitoring as one of the first clinical strategies to
Circulation: Arrhythmia and Electrophysiology, 2016
Conclusions ARFI imaging is feasible in humans using imaging equipment and catheters currently ... more Conclusions ARFI imaging is feasible in humans using imaging equipment and catheters currently available for clinical care. The CARTO SoundStar™ system helps to guide the ARFI imaging plane to annotated RFA sites.
Recurrence of atrial fibrillation after transcatheter ablation (TCA) is common because there is n... more Recurrence of atrial fibrillation after transcatheter ablation (TCA) is common because there is no imaging modality that can visually confirm the presence of radiofrequency ablation (RFA) lesions. We have previously shown that acoustic radiation force impulse (ARFI) imaging can visualize the relative tissue stiffness changes caused by RFA. The objective of this study was to determine if intra-procedurally acquired ARFI images could identify RFA lesions. In 8 canines, an integrated ARFI imaging-electroanatomical mapping (EAM) system was used to map the geometry of the right atrium and acquire ARFI images along an inter-caval line before and after RFA. RF-energy delivery sites were marked in the EAM geometry to guide the ARFI imaging plane to RFA lesion locations. The ARFI images were randomized and three separate reviewers read the images for the presence of RFA lesion. The majority assessment for each ARFI image was counted in a 2 × 2 contingency table according to the presence/absence of a RFA treatment marker in the EAM geometry at the ARFI imaging plane. EAM guided intra-procedure ARFI imaging of RFA treatment sites. Reviewers of the ARFI images identified RFA lesion with a high sensitivity (96.3%) and specificity (93.2%). Incorporating an integrated ARFI imaging-EAM system into TCA for the visualization of RFA lesions could potentially improve the procedure efficacy.
Circulation. Arrhythmia and electrophysiology, 2013
Because of the technical difficulty with achieving pulmonary vein (PV) isolation in the treatment... more Because of the technical difficulty with achieving pulmonary vein (PV) isolation in the treatment of patients with paroxysmal atrial fibrillation, novel catheter designs to facilitate the procedure are in development. A visually guided laser ablation (VGLA) catheter was designed to allow the operator to directly visualize target tissue for ablation and then deliver laser energy to perform point-to-point circumferential ablation. Single-center studies have demonstrated favorable safety and efficacy. We sought to determine the multicenter feasibility, efficacy, and safety of performing PV isolation using the VGLA catheter. This study includes the first 200 paroxysmal atrial fibrillation patients treated with the VGLA catheter (33 operators, 15 centers). After transseptal puncture, the VGLA catheter was used to perform PV isolation. Electric isolation was assessed using a circular mapping catheter. Using the VGLA catheter, 98.8% (95% confidence interval, 97.8%-99.5%) of targeted PVs we...
Pacing and Clinical Electrophysiology, 1998
![Research paper thumbnail of Corrigendum to: 'Efficacy of adjunctive ablation of complex fractionated atrial electrograms and pulmonary vein isolation for the treatment of atrial fibrillation: a meta-analysis of randomized controlled trials' [Europace 2010;13:193-204, doi:10.1093/europace/EUQ384]](https://attachments.academia-assets.com/82145994/thumbnails/1.jpg)
](Europace, 2011
for almost half the total cost of care. 5 In ATHENA, it can be demonstrated that the reduction in... more for almost half the total cost of care. 5 In ATHENA, it can be demonstrated that the reduction in AF-related hospitalizations was not simply due to fewer cardioversions, but also to a decrease in the severity of recurrent atrial fibrillation episodes. If we conclude that reasons for cardiovascular hospitalization in ATHENA were pre-specified, it would be also interesting to clearly characterize and pre-specify the reasons for non-cardiovascular hospitalizations. For example, it is well known that during the development of dronedarone the problem of lever toxicity has not been clearly observed. In the DIONYSOS (Dronedarone vs. Amiodarone for the Maintenance of Sinus Rhythm in Patients with Atrial Fibrillation) trial, 6 the rate of elevation of alanine aminotransferase levels in the dronedarone group was higher than in the previous trials, but similar to that observed in the case of amiodarone. It is known that in the ATHENA trial, cardiovascular mortality but not total mortality, was significantly decreased. Thus, it would have been interesting to analyse the reasons for noncardiovascular hospitalizations in ATHENA. Reservations have been made about the relevance of hospitalizations in the trials analysing the effects of antiarrhythmic drugs in atrial fibrillation. Indeed, it remains difficult to accurately characterize the reason for hospitalization in a multicentre trial, considering that there are different clinical practices in different countries. Nevertheless, it is plausible to assume that if the reasons for hospitalization are clearly pre-specified, hospitalization could be considered a relevant endpoint.
Journal of the American …, 2004
Background: The short-term reliability of patient reported symptoms as a marker of atrial tachyar... more Background: The short-term reliability of patient reported symptoms as a marker of atrial tachyarrhythmia or atrial fibrillation (AT/AF) recurrence has been studied. However, the long-term correlation of symptoms with continuous monitoring of AT/AF episodes during pacing is unknown. Methods: This prospective multicenter trial assessed the development of AT/AF in paced patients by examining the correlation of patient-reported symptoms with device-detected AT/AF event data in patients with bradyarrhythmias and > 1 episode of AT/AF in the prior year. Full disclosure device datalogs with electrogram (EGM) validation of AT/AF events were obtained from a pacemaker (AT500, Medtronic) that records the daily frequency, atrial and ventricular cycle length, EGM, and duration of AT/AF episodes. Patients logged symptomatic events into the device memory via an external manual activator. Following a one-month lead-in period, patients were followed for an additional 12 months and were contacted weekly to ensure compliance with activator usage. Episodes were classified as symptomatic AT/AF, asymptomatic AT/AF, or symptomatic "non-AT/AF" depending on concordance between patient-indicated symptoms and device-detected AT/AF. Results: 48 patients (28 M, 76±10 yr) were implanted and followed for 12±2 months. Arrhythmia-related symptoms were noted in 8% of all device-detected AT/AF episodes (sensitivity).Only 19% of all patient symptoms were associated with device documented AT/AF events (positive predictive value). A paired analysis in a subset of patients (n=15) with both symptomatic and asymptomatic stored episodes indicated no difference (p=NS) with respect to median ventricular rate (94 vs 94 bpm), atrial cycle length (230 vs 235 ms), or episode duration (103 vs 75 s). Conclusion: Over a long-term follow-up, the vast majority of AT/AF episodes are asymptomatic and patient symptoms are seldom associated with AT/AF episodes. Hence, patient symptoms are an unreliable index of recurrent AF in clinical studies of AF therapies and in management of anticoagulation therapy. Continuous monitoring via implantable device datalogs provides objective early and reliable detection of AF during followup.
Heart rhythm, Apr 1, 2018
Compared with men, women have longer corrected QT (QTc) intervals, lower clearance of dofetilide,... more Compared with men, women have longer corrected QT (QTc) intervals, lower clearance of dofetilide, and higher rates of drug-induced torsades de pointes, but the dofetilide dosing algorithm is the same for men and women. The purpose of this study was to evaluate the tolerability of the 500 μg twice daily dose of dofetilide for men and women. Men and women admitted to Duke University Medical Center (January 1, 2006, to October 19, 2012) for the initiation of dofetilide 500 μg twice daily were matched 1:1 on age and estimated creatinine clearance. Electrocardiograms throughout dosing were analyzed, and rates of dofetilide discontinuations and dose reductions were compared in unadjusted and adjusted analyses. For 220 matched men and women, the median age was 62.5 years (interquartile range 55-69 years) and the median eCrCl was 98.1 mL/min (interquartile range 77.6-126.2 mL/min). Women were less likely than men to have hypertension and interventricular conduction delay but were otherwise ...
Heart rhythm, Sep 14, 2017
Atrioesophageal fistula formation is a rare but life-threatening complication of AF ablation. Con... more Atrioesophageal fistula formation is a rare but life-threatening complication of AF ablation. Contact force (CF) sensing catheters improve procedural effectiveness. However, the impact of the implementation of CF-sensing technology on risk of atrioesophageal fistula formation has not been explored. To determine the association between the use of CF sensing catheters and atrioesophageal fistula development METHODS: We searched the Manufacturer and User Facility Device Experience (MAUDE) database for adverse event reports involving FDA approved ablation catheters. Among 2689 device reports, we identified 78 atrioesophageal fistula cases, 65 of which involved CF-sensing catheters and 13 non-CF sensing catheters. The percentage of total reports involving atrioeosphageal fistula was 5.4% (65/1202) for CF sensing and 0.9% (13/1487) for non-CF sensing catheters (p< 0.0001). Procedural details (CF and power settings) were not consistently reported. Esophageal temperature increases were d...
Pacing and Clinical Electrophysiology, 2017
Symptomatic sinus node dysfunction (SND) consists of a variety of manifestations, including tachy... more Symptomatic sinus node dysfunction (SND) consists of a variety of manifestations, including tachycardia-bradycardia syndrome. Atrial fibrillation (AF) is commonly associated with SND, which complicates the management of both conditions. This paper reviews the epidemiology, pathophysiology, and clinical trial data investigating therapeutic approaches for treatment of patients with both SND and AF. The authors reviewed articles published in English describing the epidemiology, pathophysiology, and therapeutic approaches for patients with SND and AF. The search was conducted using PubMed. Keywords included: sick sinus syndrome, sinus node dysfunction, atrial fibrillation, pacing, and pulmonary vein isolation. SND affects up to one in five patients with AF. AF can lead to anatomical and electrophysiological remodeling in both atria, including the region of sinoatrial node. Changes including atrial fibrosis, altered calcium channel metabolism, and transformed gene expression have been demonstrated in patients with AF and SND. Nonrandomized clinical trial data have failed to demonstrate whether any pacing strategy can reduce the risk of AF. Pulmonary vein isolation appears to decrease episodes of tachybrady syndrome and sinus pauses. SND affects up to one in five patients with AF. The pathophysiological derangements in gene expression, ion channel metabolism, and alterations in myocardial architecture associated with AF may lead to anatomic and electrical changes in the region of the sinoatrial node. Ablation may improve symptoms associated with SND in patients with AF. Future randomized trials are needed to clarify the epidemiology and optimal management of patients with SND and AF.
The American Journal of Cardiology, 2017
The utility of routine transesophageal echocardiography (TEE) to exclude left atrial appendage (L... more The utility of routine transesophageal echocardiography (TEE) to exclude left atrial appendage (LAA) thrombus before atrial fibrillation (AF) ablation in patients treated with nonvitamin K oral anticoagulant (NOAC) therapy is unclear. This single-center retrospective study sought to investigate the incidence of LAA thrombus in patients undergoing routine TEE before AF ablation treated with warfarin or NOAC therapy. We included 937 routine pre-AF ablation TEE procedures performed in patients treated with warfarin (n = 517) or NOAC (n = 420). Patients were anticoagulated without interruption for at least 4 consecutive weeks before the TEE. Patients treated with warfarin had lower LAA velocity and underwent TEE earlier in the study period than those treated with NOAC (p &amp;amp;amp;amp;amp;amp;amp;lt;0.05). The incidence of LAA thrombus was higher in patients treated with warfarin (1.55%, 8 of 517) compared with patients treated with NOAC (0.24%, 1 of 420, p = 0.0473 for difference). No LAA thrombus was identified in NOAC-treated patients with a CHA2DS2-VASC score &amp;amp;amp;amp;amp;amp;amp;lt;5 and in warfarin-treated patients with a CHA2DS2-VASC score &amp;amp;amp;amp;amp;amp;amp;lt;2. TEE-related complications occurred in 3 of 937 procedures (0.3%). In conclusion, LAA thrombus is detected rarely during pre-AF ablation TEE. Treatment with an NOAC is associated with a lower incidence of pre-AF ablation LAA thrombus compared with warfarin.
Journal of Cardiovascular Electrophysiology, 2016
Percutaneous catheter ablation for atrial fibrillation (AF) is a proven treatment strategy, but i... more Percutaneous catheter ablation for atrial fibrillation (AF) is a proven treatment strategy, but its modest long-term efficacy suggests further research is needed to guide selection of optimal, patient-specific ablation approaches. It is widely believed that pulmonary vein (PV) isolation is a critical component of catheter ablation for AF,1,2 as evidenced by the frequent finding of PV reconnection during repeat ablation procedures in cases of arrhythmia recurrence.3,4 Durable electrical isolation of the PVs using percutaneous endocardial radiofrequency ablation (RFA) requires delivery of circumferential, contiguous, and transmural lesions encompassing the PV antra. Although acute (intraprocedural) electrical isolation is ensured by demonstration of conduction block, high rates of PV reconnection are found across studies. Unrecognized gaps or nontransmural lesions in the initially delivered ablation lines have been suggested as culprits for this common occurrence,5 highlighting the need for improved methods to guide lesion delivery and assessment. Other factors such as reverse remodeling after restoration of sinus rhythm6 or a dynamic safety factor for conduction relating to nonhomogenous injury at ablation sites7,8 could also account for late PV reconnection. Given the importance of achieving durable PV isolation during an index procedure, a primary task for operators performing therapeutic ablation for AF is to devise and utilize strategies to more reliably deliver contiguous, transmural lesions at the PV antra, and/or to more accurately identify regions of incomplete ablation recommending additional lesion delivery. Radiofrequency (RF) energy delivery is the preeminent ablation modality, and is widely used for curative percutaneous catheter based treatment of supraventricular arrhythmias including AF. Early studies identified changes in the impedance of the ablation circuit (between the endocardial catheter tip and cutaneous grounding patch) during RF energy delivery as indicative of tissue heating, the degree of catheter tip contact, and lesion formation. This led to impedance monitoring as one of the first clinical strategies to
Circulation: Arrhythmia and Electrophysiology, 2016
Conclusions ARFI imaging is feasible in humans using imaging equipment and catheters currently ... more Conclusions ARFI imaging is feasible in humans using imaging equipment and catheters currently available for clinical care. The CARTO SoundStar™ system helps to guide the ARFI imaging plane to annotated RFA sites.
Recurrence of atrial fibrillation after transcatheter ablation (TCA) is common because there is n... more Recurrence of atrial fibrillation after transcatheter ablation (TCA) is common because there is no imaging modality that can visually confirm the presence of radiofrequency ablation (RFA) lesions. We have previously shown that acoustic radiation force impulse (ARFI) imaging can visualize the relative tissue stiffness changes caused by RFA. The objective of this study was to determine if intra-procedurally acquired ARFI images could identify RFA lesions. In 8 canines, an integrated ARFI imaging-electroanatomical mapping (EAM) system was used to map the geometry of the right atrium and acquire ARFI images along an inter-caval line before and after RFA. RF-energy delivery sites were marked in the EAM geometry to guide the ARFI imaging plane to RFA lesion locations. The ARFI images were randomized and three separate reviewers read the images for the presence of RFA lesion. The majority assessment for each ARFI image was counted in a 2 × 2 contingency table according to the presence/absence of a RFA treatment marker in the EAM geometry at the ARFI imaging plane. EAM guided intra-procedure ARFI imaging of RFA treatment sites. Reviewers of the ARFI images identified RFA lesion with a high sensitivity (96.3%) and specificity (93.2%). Incorporating an integrated ARFI imaging-EAM system into TCA for the visualization of RFA lesions could potentially improve the procedure efficacy.
Circulation. Arrhythmia and electrophysiology, 2013
Because of the technical difficulty with achieving pulmonary vein (PV) isolation in the treatment... more Because of the technical difficulty with achieving pulmonary vein (PV) isolation in the treatment of patients with paroxysmal atrial fibrillation, novel catheter designs to facilitate the procedure are in development. A visually guided laser ablation (VGLA) catheter was designed to allow the operator to directly visualize target tissue for ablation and then deliver laser energy to perform point-to-point circumferential ablation. Single-center studies have demonstrated favorable safety and efficacy. We sought to determine the multicenter feasibility, efficacy, and safety of performing PV isolation using the VGLA catheter. This study includes the first 200 paroxysmal atrial fibrillation patients treated with the VGLA catheter (33 operators, 15 centers). After transseptal puncture, the VGLA catheter was used to perform PV isolation. Electric isolation was assessed using a circular mapping catheter. Using the VGLA catheter, 98.8% (95% confidence interval, 97.8%-99.5%) of targeted PVs we...
Pacing and Clinical Electrophysiology, 1998
Europace, 2011
for almost half the total cost of care. 5 In ATHENA, it can be demonstrated that the reduction in... more for almost half the total cost of care. 5 In ATHENA, it can be demonstrated that the reduction in AF-related hospitalizations was not simply due to fewer cardioversions, but also to a decrease in the severity of recurrent atrial fibrillation episodes. If we conclude that reasons for cardiovascular hospitalization in ATHENA were pre-specified, it would be also interesting to clearly characterize and pre-specify the reasons for non-cardiovascular hospitalizations. For example, it is well known that during the development of dronedarone the problem of lever toxicity has not been clearly observed. In the DIONYSOS (Dronedarone vs. Amiodarone for the Maintenance of Sinus Rhythm in Patients with Atrial Fibrillation) trial, 6 the rate of elevation of alanine aminotransferase levels in the dronedarone group was higher than in the previous trials, but similar to that observed in the case of amiodarone. It is known that in the ATHENA trial, cardiovascular mortality but not total mortality, was significantly decreased. Thus, it would have been interesting to analyse the reasons for noncardiovascular hospitalizations in ATHENA. Reservations have been made about the relevance of hospitalizations in the trials analysing the effects of antiarrhythmic drugs in atrial fibrillation. Indeed, it remains difficult to accurately characterize the reason for hospitalization in a multicentre trial, considering that there are different clinical practices in different countries. Nevertheless, it is plausible to assume that if the reasons for hospitalization are clearly pre-specified, hospitalization could be considered a relevant endpoint.
Journal of the American …, 2004
Background: The short-term reliability of patient reported symptoms as a marker of atrial tachyar... more Background: The short-term reliability of patient reported symptoms as a marker of atrial tachyarrhythmia or atrial fibrillation (AT/AF) recurrence has been studied. However, the long-term correlation of symptoms with continuous monitoring of AT/AF episodes during pacing is unknown. Methods: This prospective multicenter trial assessed the development of AT/AF in paced patients by examining the correlation of patient-reported symptoms with device-detected AT/AF event data in patients with bradyarrhythmias and > 1 episode of AT/AF in the prior year. Full disclosure device datalogs with electrogram (EGM) validation of AT/AF events were obtained from a pacemaker (AT500, Medtronic) that records the daily frequency, atrial and ventricular cycle length, EGM, and duration of AT/AF episodes. Patients logged symptomatic events into the device memory via an external manual activator. Following a one-month lead-in period, patients were followed for an additional 12 months and were contacted weekly to ensure compliance with activator usage. Episodes were classified as symptomatic AT/AF, asymptomatic AT/AF, or symptomatic "non-AT/AF" depending on concordance between patient-indicated symptoms and device-detected AT/AF. Results: 48 patients (28 M, 76±10 yr) were implanted and followed for 12±2 months. Arrhythmia-related symptoms were noted in 8% of all device-detected AT/AF episodes (sensitivity).Only 19% of all patient symptoms were associated with device documented AT/AF events (positive predictive value). A paired analysis in a subset of patients (n=15) with both symptomatic and asymptomatic stored episodes indicated no difference (p=NS) with respect to median ventricular rate (94 vs 94 bpm), atrial cycle length (230 vs 235 ms), or episode duration (103 vs 75 s). Conclusion: Over a long-term follow-up, the vast majority of AT/AF episodes are asymptomatic and patient symptoms are seldom associated with AT/AF episodes. Hence, patient symptoms are an unreliable index of recurrent AF in clinical studies of AF therapies and in management of anticoagulation therapy. Continuous monitoring via implantable device datalogs provides objective early and reliable detection of AF during followup.