Prasant Mohanty

Feasibility and Safety of Dabigatran Versus Warfarin for Periprocedural Anticoagulation in Patients Undergoing Radiofrequency Ablation for Atrial Fibrillation Results From a Multicenter Prospective Registry

OBJECTIVES The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation. BACKGROUND AF ablation requires optimal periprocedural anticoagulation for minimizing bleeding and thromboembolic complications. The safety and efficacy of dabigatran as a periprocedural anticoagulant for AF ablation are unknown. METHODS We performed a multicenter, observational study from a prospective registry including all consecutive patients undergoing AF ablation in 8 high-volume centers in the United States. All patients receiving dabigatran therapy who underwent AF ablation on periprocedural dabigatran, with the dose held on the morning of the procedure, were matched by age, sex, and type of AF with an equal number of patients undergoing AF ablation with uninterrupted warfarin therapy over the same period. RESULTS A total of 290 patients, including 145 taking periprocedural dabigatran and an equal number of matched patients taking uninterrupted periprocedural warfarin, were included in the study. The mean age was 60 years with 79% being male and 57% having paroxysmal AF. Both groups had a similar CHADS(2) score, left atrial size, and left ventricular ejection fraction. Three thromboembolic complications (2.1%) occurred in the dabigatran group compared with none in the warfarin group (p = 0.25). The dabigatran group had a significantly higher major bleeding rate (6% vs. 1%; p = 0.019), total bleeding rate (14% vs. 6%; p = 0.031), and composite of bleeding and thromboembolic complications (16% vs. 6%; p = 0.009) compared with the warfarin group. Dabigatran use was confirmed as an independent predictor of bleeding or thromboembolic complications (odds ratio: 2.76, 95% confidence interval: 1.22 to 6.25; p = 0.01) on multivariate regression analysis. CONCLUSIONS In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.

Does the left atrial appendage morphology correlate with the risk of stroke in patients with atrial fibrillation?: results from a multicenter study.

OBJECTIVES This study investigated the left atrial appendage (LAA) by computed tomography (CT) and magnetic resonance imaging (MRI) to categorize different LAA morphologies and to correlate the morphology with the history of stroke/transient ischemic attack (TIA). BACKGROUND LAA represents one of the major sources of cardiac thrombus formation responsible for TIA/stroke in patients with atrial fibrillation (AF). METHODS We studied 932 patients with drug-refractory AF who were planning to undergo catheter ablation. All patients underwent cardiac CT or MRI of the LAA and were screened for history of TIA/stroke. Four different morphologies were used to categorize LAA: Cactus, Chicken Wing, Windsock, and Cauliflower. RESULTS CT scans of 499 patients and MRI scans of 433 patients were analyzed (age 59 ± 10 years, 79% were male, and 14% had CHADS(2) [Congestive heart failure, hypertension, Age >75, Diabetes mellitus, and prior stroke or transient ischemic attack] score ≥2). The distribution of different LAA morphologies was Cactus (278 [30%]), Chicken Wing (451 [48%]), Windsock (179 [19%]), and Cauliflower (24 [3%]). Of the 932 patients, 78 (8%) had a history of ischemic stroke or TIA. The prevalence of pre-procedure stroke/TIA in Cactus, Chicken Wing, Windsock, and Cauliflower morphologies was 12%, 4%, 10%, and 18%, respectively (p = 0.003). After controlling for CHADS2 score, gender, and AF types in a multivariable logistic model, Chicken Wing morphology was found to be 79% less likely to have a stroke/TIA history (odd ratio: 0.21, 95% confidence interval: 0.05 to 0.91, p = 0.036). In a separate multivariate model, we entered Chicken Wing as the reference group and assessed the likelihood of stroke in other groups in relation to reference. Compared with chicken wing, cactus was 4.08 times (p = 0.046), Windsock was 4.5 times (p = 0.038), and Cauliflower was 8.0 times (p = 0.056) more likely to have had a stroke/TIA. CONCLUSIONS Patients with Chicken Wing LAA morphology are less likely to have an embolic event even after controlling for comorbidities and CHADS2 score. If confirmed, these results could have a relevant impact on the anticoagulation management of patients with a low-intermediate risk for stroke/TIA.

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. Conclusion— 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.

Periprocedural Stroke and Bleeding Complications in Patients Undergoing Catheter Ablation of Atrial Fibrillation With Different Anticoagulation Management Results From the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) Randomized Trial

Background— Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. Methods and Results— This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1–55.6; P<0.001). Conclusion— This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01006876.

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.

Endo-epicardial homogenization of the scar versus limited substrate ablation for the treatment of electrical storms in patients with ischemic cardiomyopathy.

OBJECTIVES This study investigated the impact on recurrences of 2 different substrate approaches for the treatment of these arrhythmias. BACKGROUND Catheter ablation of electrical storms (ES) for ventricular arrhythmias (VAs) has shown moderate long-term efficacy in patients with ischemic cardiomyopathy. METHODS Ninety-two consecutive patients (81% male, age 62 ± 13 years) with ischemic cardiomyopathy and ES underwent catheter ablation. Patients were treated either by confining the radiofrequency lesions to the endocardial surface with limited substrate ablation (Group 1, n = 49) or underwent endocardial and epicardial ablation of abnormal potentials within the scar (homogenization of the scar, Group 2, n = 43). Epicardial access was obtained in all Group 2 patients, whereas epicardial ablation was performed in 33% (14) of these patients. RESULTS Mean ejection fraction was 27 ± 5. During a mean follow-up of 25 ± 10 months, the VAs recurrence rate of any ventricular tachycardia (VTs) was 47% (23 of 49 patients) in Group 1 and 19% (8 of 43 patients) in Group 2 (log-rank p = 0.006). One patient in Group 1 and 1 patient in Group 2 died at follow-up for noncardiac reasons. CONCLUSIONS Our study demonstrates that ablation using endo-epicardial homogenization of the scar significantly increases freedom from VAs in ischemic cardiomyopathy patients.

Periprocedural Stroke and Bleeding Complications in Patients undergoing Catheter Ablation of Atrial Fibrillation with Different Anticoagulation Management: Results from the "COMPARE" Randomized Trial

Background— Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. Methods and Results— This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1–55.6; P<0.001). Conclusion— This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01006876.

The Risk of Thromboembolism and Need for Oral Anticoagulation After Successful Atrial Fibrillation Ablation

OBJECTIVES The aim of this multicenter study was to evaluate the safety of discontinuing oral anticoagulation therapy (OAT) after apparently successful pulmonary vein isolation. BACKGROUND Atrial fibrillation (AF) is associated with an increased risk of thromboembolic events (TE) and often requires OAT. Pulmonary vein isolation is considered an effective treatment for AF. METHODS We studied 3,355 patients, of whom 2,692 (79% male, mean age 57 +/- 11 years) discontinued OAT 3 to 6 months after ablation (Off-OAT group) and 663 (70% male, mean age 59 +/- 11 years) remained on OAT after this period (On-OAT group). CHADS(2) (congestive heart failure, hypertension, age [75 years and older], diabetes mellitus, and a history of stroke or transient ischemic attack) risk scores of 1 and > or =2 were recorded in 723 (27%) and 347 (13%) Off-OAT group patients and in 261 (39%) and 247 (37%) On-OAT group patients, respectively. RESULTS During follow-up (mean 28 +/- 13 months vs. 24 +/- 15 months), 2 (0.07%) Off-OAT group patients and 3 (0.45%) On-OAT group patients had an ischemic stroke (p = 0.06). No other thromboembolic events occurred. No Off-OAT group patient with a CHADS(2) risk score of > or =2 had an ischemic stroke. A major hemorrhage was observed in 1 (0.04%) Off-OAT group patient and 13 (2%) On-OAT group patients (p < 0.0001). CONCLUSIONS In this nonrandomized study, the risk-benefit ratio favored the suspension of OAT after successful AF ablation even in patients at moderate-high risk of TE. This conclusion needs to be confirmed by future large randomized trials.

Ablation of Ventricular Arrhythmias in Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy: Arrhythmia-Free Survival after Endo-Epicardial Substrate Based Mapping and Ablation

Background— In patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy, freedom from ventricular arrhythmias (VAs) after endocardial ablation is limited. We compared the long-term freedom from recurrent VAs by using endocardial-alone ablation versus endo-epicardial substrate-based ablation. Methods and Results— Forty-nine patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy undergoing ablation of ventricular tachycardia (VT) were divided into 2 groups: endocardial-alone ablation (group 1, n=23) and endo-epicardial ablation (group 2, n=26). All patients had an implantable cardioverter-defibrillator (ICD). Conventional and 3D mappings were used to determine the mechanism of induced VTs and to identify area of “scar” or “abnormal” myocardium. All critical sites responsible for VTs and points with “abnormal” potential were targeted for ablation from endocardium (group 1) or from both endocardium and epicardium (group 2). The procedural end point was noninducibility of sustained, monomorphic VT with isoproterenol. The presence of frequent premature ventricular contractions at the end of ablation was recorded. Patients were followed up by ECG, Holter, and ICD interrogation. After a follow-up of at least 3 years, freedom from VAs or ICD therapy was 52.2% (12/23) in group 1 and 84.6% (22/26) in group 2 (P=0.029), with 21.7% (5/23) and 69.2% (18/26) patients off antiarrhythmic drugs (P<0.001), respectively. Compared with patients with no premature ventricular contractions after ablation, patients with frequent premature ventricular contractions after ablation were more likely to have VA recurrence/ICD therapy [3/33 (9%) versus 12/16 (75%); log-rank P<0.001]. Conclusions— An endo-epicardial–based ablation strategy achieves higher long-term freedom from recurrent VAs off antiarrhythmic therapy in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy when compared with endocardial-alone ablation. The presence of ≥10 premature ventricular contractions per minute after ablation is associated with more VA recurrence.Background— In patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy, freedom from ventricular arrhythmias (VAs) after endocardial ablation is limited. We compared the long-term freedom from recurrent VAs by using endocardial-alone ablation versus endo-epicardial substrate-based ablation. Methods and Results— Forty-nine patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy undergoing ablation of ventricular tachycardia (VT) were divided into 2 groups: endocardial-alone ablation (group 1, n=23) and endo-epicardial ablation (group 2, n=26). All patients had an implantable cardioverter-defibrillator (ICD). Conventional and 3D mappings were used to determine the mechanism of induced VTs and to identify area of “scar” or “abnormal” myocardium. All critical sites responsible for VTs and points with “abnormal” potential were targeted for ablation from endocardium (group 1) or from both endocardium and epicardium (group 2). The procedural end point was noninducibility of sustained, monomorphic VT with isoproterenol. The presence of frequent premature ventricular contractions at the end of ablation was recorded. Patients were followed up by ECG, Holter, and ICD interrogation. After a follow-up of at least 3 years, freedom from VAs or ICD therapy was 52.2% (12/23) in group 1 and 84.6% (22/26) in group 2 ( P =0.029), with 21.7% (5/23) and 69.2% (18/26) patients off antiarrhythmic drugs ( P <0.001), respectively. Compared with patients with no premature ventricular contractions after ablation, patients with frequent premature ventricular contractions after ablation were more likely to have VA recurrence/ICD therapy [3/33 (9%) versus 12/16 (75%); log-rank P <0.001]. Conclusions— An endo-epicardial–based ablation strategy achieves higher long-term freedom from recurrent VAs off antiarrhythmic therapy in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy when compared with endocardial-alone ablation. The presence of ≥10 premature ventricular contractions per minute after ablation is associated with more VA recurrence.