Madhu Reddy

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.

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.

Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial

Background— Whether catheter ablation (CA) is superior to amiodarone (AMIO) for the treatment of persistent atrial fibrillation (AF) in patients with heart failure is unknown. Methods and Results— This was an open-label, randomized, parallel-group, multicenter study. Patients with persistent AF, dual-chamber implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator, New York Heart Association II to III, and left ventricular ejection fraction <40% within the past 6 months were randomly assigned (1:1 ratio) to undergo CA for AF (group 1, n=102) or receive AMIO (group 2, n=101). Recurrence of AF was the primary end point. All-cause mortality and unplanned hospitalization were the secondary end points. Patients were followed up for a minimum of 24 months. At the end of follow-up, 71 (70%; 95% confidence interval, 60%–78%) patients in group 1 were recurrence free after an average of 1.4±0.6 procedures in comparison with 34 (34%; 95% confidence interval, 25%–44%) in group 2 (log-rank P<0.001). The success rate of CA in the different centers after a single procedure ranged from 29% to 61%. After adjusting for covariates in the multivariable model, AMIO therapy was found to be significantly more likely to fail (hazard ratio, 2.5; 95% confidence interval, 1.5–4.3; P<0.001) than CA. Over the 2-year follow-up, the unplanned hospitalization rate was (32 [31%] in group 1 and 58 [57%] in group 2; P<0.001), showing 45% relative risk reduction (relative risk, 0.55; 95% confidence interval, 0.39–0.76). A significantly lower mortality was observed in CA (8 [8%] versus AMIO (18 [18%]; P=0.037). Conclusions— This multicenter randomized study shows that CA of AF is superior to AMIO in achieving freedom from AF at long-term follow-up and reducing unplanned hospitalization and mortality in patients with heart failure and persistent AF. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729911.

FREEDOM FROM RECURRENT VENTRICULAR TACHYCARDIA AFTER CATHETER ABLATION IS ASSOCIATED WITH IMPROVED SURVIVAL IN PATIENTS WITH STRUCTURAL HEART DISEASE: AN INTERNATIONAL VT ABLATION CENTER COLLABORATIVE GROUP STUDY

BACKGROUND The impact of catheter ablation of ventricular tachycardia (VT) on all-cause mortality remains unknown. OBJECTIVE The purpose of this study was to examine the association between VT recurrence after ablation and survival in patients with scar-related VT. METHODS Analysis of 2061 patients with structural heart disease referred for catheter ablation of scar-related VT from 12 international centers was performed. Data on clinical and procedural variables, VT recurrence, and mortality were analyzed. Kaplan-Meier analysis was used to estimate freedom from recurrent VT, transplant, and death. Cox proportional hazards frailty models were used to analyze the effect of risk factors on VT recurrence and mortality. RESULTS One-year freedom from VT recurrence was 70% (72% in ischemic and 68% in nonischemic cardiomyopathy). Fifty-seven patients (3%) underwent cardiac transplantation, and 216 (10%) died during follow-up. At 1 year, the estimated rate of transplant and/or mortality was 15% (same for ischemic and nonischemic cardiomyopathy). Transplant-free survival was significantly higher in patients without VT recurrence than in those with recurrence (90% vs 71%, P<.001). In multivariable analysis, recurrence of VT after ablation showed the highest risk for transplant and/or mortality [hazard ratio 6.9 (95% CI 5.3-9.0), P<.001]. In patients with ejection fraction <30% and across all New York Heart Association functional classes, improved transplant-free survival was seen in those without VT recurrence. CONCLUSION Catheter ablation of VT in patients with structural heart disease results in 70% freedom from VT recurrence, with an overall transplant and/or mortality rate of 15% at 1 year. Freedom from VT recurrence is associated with improved transplant-free survival, independent of heart failure severity.

Importance of non–pulmonary vein triggers ablation to achieve long-term freedom from paroxysmal atrial fibrillation in patients with low ejection fraction

BACKGROUND Whether ablation of non-pulmonary vein (PV) triggers after pulmonary vein antrum isolation (PVAI) improves the long-term procedure outcome in patients with paroxysmal atrial fibrillation (PAF) and left ventricular systolic dysfunction is unknown. OBJECTIVE We sought to evaluate whether a more extensive ablation procedure improves outcomes at follow-up. METHODS Consecutive patients with PAF refractory to antiarrhythmic drugs presenting for PVAI were prospectively studied. Patients were categorized into 2 groups: patients with left ventricular ejection fraction (LVEF) ≤35% (group I; n = 175) and patients with LVEF ≥50% (group II; n = 545). Patients in group I were further divided according to whether additional ablation of non-PV triggers was performed (group IA; n = 88) or not (group IB; n = 87). Long-term ablation success off antiarrhythmic drugs after a single procedure was analyzed. RESULTS Patients in group I had more non-PV triggers than did patients in group II (69.1% vs 26.6%; P < .001). During a follow-up of 15.8 ± 4.7 months, fewer patients in group I remained free from recurrences than those in group II (53.7% vs 81.7%; P < .001). Long-term ablation success was higher in group IA than in group IB (75.0% vs 32.2%; P < .001) and similar to that in group II (75.0% vs 81.7%; P = .44). In multivariate analysis, LVEF ≤35% (hazard ratio 1.68; P = .003) and non-PV triggers (hazard ratio 3.12; P < .001) were independent predictors of recurrences. CONCLUSION In patients with PAF and left ventricular systolic dysfunction, ablation of non-PV triggers in addition to PVAI significantly improves their long-term procedure outcome.

IMPACT OF LEFT ATRIAL APPENDAGE EXCLUSION ON SYSTEMIC HOMEOSTASIS (THE LAA HOMEOSTASIS STUDY)

Left atrial appendage (LAA) a major source of ANP (atrial natriuretic peptide) which can influence the endocrine axis. The physiologic effects of LAA exclusion on systemic homeostasis have not been previously studied. 37 consecutive patients (7 women (19%)/30 men (81%); age 71±8; CHAD2 2.6±1.1;

Use of contact force sensing technology during radiofrequency ablation reduces recurrence of atrial fibrillation: A systematic review and meta-analysis

The suboptimal outcomes of atrial fibrillation (AF) ablation have been attributed to lack of transmural lesions during pulmonary vein isolation. The advent of contact force (CF) sensing technology enables real-time assessment of the applied force at the catheter-tissue interface and increases the chances of transmural lesions. We sought to perform a meta-analysis of data from eligible studies to delineate the true impact of CF technology. Database searches through April 2015 identified 9 eligible studies (enrolling 1148 patients). The relative risk of AF recurrence at follow-up was used as the primary end point and assessed with random-effects meta-analysis. Radiofrequency (RF) duration, total procedure length, and fluoroscopy exposure were assessed as secondary outcomes using weighted mean difference with the random-effects model. Compared with standard technology, the use of CF technology showed a 37% reduction (relative risk 0.63; 95% confidence interval 0.44-0.91; P = .01) in AF recurrence at a median follow-up of 12 months and a 7.3-minute reduction (95% confidence interval -14.05 to -0.55; P = .03) in RF use during ablation. There was no significant difference in total procedure length and fluoroscopy exposure between the 2 groups. In conclusion, this meta-analysis shows that the use of CF technology decreases AF recurrence at a median follow-up of 12 months and also led to decreased use of RF during ablation. There was no difference in total procedure length and fluoroscopy exposure.

Differences in complication rates between large bore needle and a long micropuncture needle during epicardial access: time to change clinical practice?

Background—A dry epicardial access (EA) is increasingly used for advanced cardiovascular procedures. Conventionally used large bore needles (Tuohy or Pajunk needle; LBN) have been associated with low but definite incidence of major complications with EA. Use of micropuncture needle (MPN) may decrease the risk of complications. We intended to compare the outcomes of LBN with MPN for EA. Methods and Results—We report a multicenter observational study of consecutive patients who underwent EA for ventricular tachycardia ablation or Lariat procedure using the LBN or MPN. Oral anticoagulation was stopped before the procedure. Baseline characteristics and procedure-related complications were collected and compared. Of the 404 patients, LBN and MPN were used in 46% and 54% of patients, respectively. There was no significant difference in the incidence of inadvertent puncture of myocardium between LBN and MPN (7.6% versus 6.8%, P=0.76). However, there was a significantly higher rate of large pericardial effusions with LBN compared with MPN (8.1% versus 0.9%; P<0.001). The incidence of pleural effusions were not significantly different between both (1.6% versus 2.3%; P=0.64). LBN group had an increase in other complications compared with MPN (open heart surgery to repair cardiac laceration [6 versus 0], injury to liver [1 versus 0], coronaries [1 versus 0], and superior epigastric artery requiring surgical exploration [0 versus 1]). Conclusions—The use of MPN is associated with decreased incidence of major complications, and the need for surgical repair and routine use should be considered for EA.

Effect of periprocedural amiodarone on procedure outcome in patients with longstanding persistent atrial fibrillation undergoing extended pulmonary vein antrum isolation: Results from a randomized study (SPECULATE)

BACKGROUND The impact of amiodarone on ablation outcome in longstanding persistent atrial fibrillation (LSPAF) patients is not known yet. OBJECTIVE The purpose of this study was to assess the effect of amiodarone on procedural-outcomes in LSPAF patients undergoing catheter ablation. METHODS We enrolled 112 LSPAF patients on amiodarone and scheduled to undergo atrial fibrillation (AF) ablation. Patients were randomized to amiodarone discontinuation 4 months before ablation (group 1, n = 56) and a control group (group 2, n = 56) in which ablation was performed without amiodarone discontinuation. All patients underwent pulmonary vein (PV) antrum and posterior wall isolation, defragmentation and extra PV triggers ablation. Patients were followed up for recurrence for 32 ± 8 months post-ablation. Repeat procedures in all recurrent patients were performed off amiodarone. RESULTS During ablation, AF termination was more frequent in group 2 compared to group 1 [44 (79%) vs 32 (57%), P = .015]. After high-dosage isoproterenol, more non-PV triggers were disclosed in group 1 compared to group 2 (42 [75%] vs 24 [43%] respectively, P <.001). Group 2 had lower procedure, radiofrequency and fluoroscopy times compared to group 1 (2.7 ± 1 vs 3.1 ± 1 h, 69 ± 13 min vs 87 ± 11 min and 64 ± 14 min vs 85 ± 18 min respectively, p < .05). At 32 ± 8 month follow-up, on or off antiarrhythmic drug success rate was 37 (66%) in group 1 and 27 (48%) in group 2 (P = .04). During redo, new non-PV trigger sites were identified in group 2 patients. CONCLUSION Periprocedural continuous amiodarone was associated with higher organization rate and lower radiofrequency ablation rate. However, masking non-PV triggers increased the late recurrence rate.

Impact of Periprocedural Colchicine on Postprocedural Management in Patients Undergoing a Left Atrial Appendage Ligation Using LARIAT.

Left atrial appendage (LAA) can be effectively and safely excluded using a novel percutaneous LARIAT ligation system. However, due to pericardial catheter manipulation and LAA ligation and subsequent necrosis, postprocedural course is complicated by pericarditis. We intended to evaluate the preprocedural use of colchicine on the incidence of postprocedural pericardial complications.