Sudharani Bommana

Feasibility and Safety of Uninterrupted Rivaroxaban for Periprocedural Anticoagulation in Patients Undergoing Radiofrequency Ablation for Atrial Fibrillation

OBJECTIVES The purpose of this study was to evaluate the feasibility and safety of uninterrupted rivaroxaban therapy during atrial fibrillation (AF) ablation. BACKGROUND Optimal periprocedural anticoagulation strategy is essential for minimizing bleeding and thromboembolic complications during and after AF ablation. The safety and efficacy of uninterrupted rivaroxaban therapy as a periprocedural anticoagulant for AF ablation are unknown. METHODS We performed a multicenter, observational, prospective study of a registry of patients undergoing AF ablation in 8 centers in North America. Patients taking uninterrupted periprocedural rivaroxaban were matched by age, sex, and type of AF with an equal number of patients taking uninterrupted warfarin therapy who were undergoing AF ablation during the same period. RESULTS A total of 642 patients were included in the study, with 321 in each group. Mean age was 63 ± 10 years, with 442 (69%) males and 328 (51%) patients with paroxysmal AF equally distributed between the 2 groups. Patients in the warfarin group had a slightly higher mean HAS- BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score (1.70 ± 1.0 vs. 1.47 ± 0.9, respectively; p = 0.032). Bleeding and embolic complications occurred in 47 (7.3%) and 2 (0.3%) patients (both had transient ischemic attacks) respectively. There were no differences in the number of major bleeding complications (5 [1.6%] vs. 7 [1.9%], respectively; p = 0.772), minor bleeding complications (16 [5.0%] vs. 19 [5.9%], respectively; p = 0.602), or embolic complications (1 [0.3%] vs. 1 [0.3%], respectively; p = 1.0) between the rivaroxaban and warfarin groups in the first 30 days. CONCLUSIONS Uninterrupted rivaroxaban therapy appears to be as safe and efficacious in preventing bleeding and thromboembolic events in patients undergoing AF ablation as uninterrupted warfarin therapy.

Effect of Yoga on Arrhythmia Burden, Anxiety, Depression, and Quality of Life in Paroxysmal Atrial Fibrillation: The YOGA My Heart Study

OBJECTIVES The purpose of this study was to examine the impact of yoga on atrial fibrillation (AF) burden, quality of life (QoL), depression, and anxiety scores. BACKGROUND Yoga is known to have significant benefit on cardiovascular health. The effect of yoga in reducing AF burden is unknown. METHODS This single-center, pre-post study enrolled patients with symptomatic paroxysmal AF with an initial 3-month noninterventional observation period followed by twice-weekly 60-min yoga training for next 3 months. AF episodes during the control and study periods as well as SF-36, Zung self-rated anxiety, and Zung self-rated depression scores at baseline, before, and after the study phase were assessed. RESULTS Yoga training reduced symptomatic AF episodes (3.8 ± 3 vs. 2.1 ± 2.6, p < 0.001), symptomatic non-AF episodes (2.9 ± 3.4 vs. 1.4 ± 2.0; p < 0.001), asymptomatic AF episodes (0.12 ± 0.44 vs. 0.04 ± 0.20; p < 0.001), and depression and anxiety (p < 0.001), and improved the QoL parameters of physical functioning, general health, vitality, social functioning, and mental health domains on SF-36 (p = 0.017, p < 0.001, p < 0.001, p = 0.019, and p < 0.001, respectively). There was significant decrease in heart rate, and systolic and diastolic blood pressure before and after yoga (p < 0.001). CONCLUSIONS In patients with paroxysmal AF, yoga improves symptoms, arrhythmia burden, heart rate, blood pressure, anxiety and depression scores, and several domains of QoL.

Radiofrequency Ablation of Premature Ventricular Ectopy Improves the Efficacy of Cardiac Resynchronization Therapy in Nonresponders

OBJECTIVES This study sought to examine whether suppressing premature ventricular contractions (PVC) using radiofrequency ablation improves effectiveness of the cardiac resynchronization therapy (CRT) in nonresponders. BACKGROUND CRT is an effective strategy for drug refractory congestive heart failure. However, one-third of patients with CRT do not respond clinically, and the causes for nonresponse are poorly understood. Whether frequent PVC contribute to CRT nonresponse remains unknown. METHODS In this multicenter study, CRT nonresponders with >10,000 PVC in 24 h who underwent PVC ablation were enrolled from a prospective database. RESULTS Sixty-five subjects (age 66.6 ± 12.4 years, 78% men, QRS duration of 155 ± 18 ms) had radiofrequency ablation of PVC from 76 foci. Acute and long-term success rates of ablation were 91% and 88% in 12 ± 4 months of follow-up. There was significant improvement in left ventricular (LV) ejection fraction (26.2 ± 5.5% to 32.7 ± 6.7 %, p < 0.001), LV end-systolic diameter (5.93 ± 0.55 cm to 5.62 ± 0.32 cm, p < 0.001), LV end-diastolic diameter (6.83 ± 0.83 cm to 6.51 ± 0.91 cm, p < 0.001), LV end-systolic volume (178 ± 72 to 145 ± 23 ml, p < 0.001), LV end-diastolic volume (242 ± 85 ml to 212 ± 63 ml, p < 0.001), and median New York Heart Association functional class (3.0 to 2.0, p < 0.001). Modeling of pre-ablation PVC burden revealed an improvement in ejection fraction when the pre-ablation PVC burden was >22% in 24 h. CONCLUSIONS Frequent PVC is an uncommon yet significant cause of CRT nonresponse. Radiofrequency ablation of PVC foci improves LV function and New York Heart Association class and promotes reverse remodeling in CRT nonresponders. PVC ablation may be used to enhance CRT efficacy in nonresponders with significant PVC burden.

Short and long-term outcomes of percutaneous left atrial appendage suture ligation: Results from a US multicenter evaluation

BACKGROUND Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results. OBJECTIVE The purpose of this study was to delineate the safety and efficacy of LAA closure with the LARIAT device. METHODS This is a multicenter registry of 712 consecutive patients undergoing LAA ligation with LARIAT at 18 US hospitals. The primary end point was successful suture deployment, no leak by intraprocedural transesophageal echocardiography (TEE), and no major complication (death, stroke, cardiac perforation, and bleeding requiring transfusion) at discharge. A leak of 2-5 mm on follow-up TEE was the secondary end point. RESULTS LARIAT was successfully deployed in 682 patients (95.5%). A complete closure was achieved in 669 patients (98%), while 13 patients (1.8%) had a trace leak (<2 mm). There was 1 death related to the procedure. Ten patients (1.44%) had cardiac perforation necessitating open heart surgery, while another 14 (2.01%) did not need surgery. The risk of cardiac perforation decreased significantly after the introduction of a micropuncture (MP) needle for pericardial access. Delayed complications (pericarditis requiring >2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge) occurred in 34 (4.78%) patients, and the risk decreased significantly with the periprocedural use of colchicine. Follow-up TEE (n = 480) showed a leak of 2-5 mm in 6.5% and a thrombus in 2.5%. One patient had a leak of >5 mm. CONCLUSION LARIAT effectively closes the LAA and has acceptable procedural risks with the evolution of the use of the micropuncture needle for pericardial access and the use of colchicine for mitigating the postinflammatory response associated with LAA ligation and pericardial access.

Endocardial (Watchman) vs epicardial (Lariat) left atrial appendage exclusion devices: Understanding the differences in the location and type of leaks and their clinical implications

BACKGROUND Watchman and Lariat left atrial appendage (LAA) occlusion devices are associated with LAA leaks postdeployment. OBJECTIVE The purpose of this study was to compare the incidence, characteristics, and clinical significance of these leaks. METHODS We performed a multicenter prospective observational study of all patients who underwent LAA closure. Baseline, procedural, and imaging variables along with LAA occlusion rates at 30-90 days and 1-year postprocedure were compared. RESULTS A total of 478 patients (219 with the Watchman device and 259 with the Lariat device) with successful implants were included. Patients in the Lariat group had a higher CHADS2 (congestive heart failure, hypertension, age >74 years, diabetes, stroke) score and a larger left atrium and LAA. A total of 79 patients (17%) had a detectable leak at 1 year. More patients in the Watchman group had a leak compared with those in the Lariat group (46 [21%] vs 33 [14%]; P = .019). All the leaks were eccentric (edge effect) in the Watchman group and concentric (gunny sack effect) in the Lariat group. The size of the leak was larger in the Watchman group than in the Lariat group (3.10 ± 1.5 mm vs 2.15 ± 1.3 mm; P = .001). The Watchman group had 1 device embolization requiring surgery and 2 pericardial effusions requiring pericardiocentesis. In the Lariat group, 4 patients had cardiac tamponade requiring urgent surgical repair. Three patients in each group had a cerebrovascular accident and were not associated with device leaks. CONCLUSION The Lariat device is associated with a lower rate of leaks at 1 year as compared with the Watchman device, with no difference in rates of cerebrovascular accident. There was no correlation between the presence of residual leak and the occurrence of cerebrovascular accident.

Impact of left atrial appendage exclusion using an epicardial ligation system (LARIAT) on atrial fibrillation burden in patients with cardiac implantable electronic devices

BACKGROUND The left atrial appendage (LAA) is a well-known source of atrial arrhythmia and atrial fibrillation (AF). OBJECTIVE The purpose of this study was to determine whether LAA exclusion using the LARIAT device would decrease AF burden. METHODS A total of 50 patients with AF and cardiac implantable electronic devices who underwent successful LAA exclusion were enrolled in this prospective observational study. AF burden before LAA exclusion (baseline) and 3 and 12 months after exclusion was assessed by device interrogation. RESULTS AF burden at 3-month follow-up (42% ± 34%) was significantly lower compared to baseline (76% ± 33%, P < .0001). The reduction in AF burden was sustained at 12 months (59% ± 26%, P < .001). Subgroup analysis revealed that AF burden at 3-month follow-up was similarly reduced in both paroxysmal AF (n = 19) and nonparoxysmal AF (n = 31). However, there was no reduction in AF burden in patients with paroxysmal AF at 12 months. AF burden in patients with known AF triggers in the LAA (n = 9) was significantly reduced at 3 months (52% ± 35%) and 12 months (42% ± 19%) compared to respective baseline (84 ± 31%, P < .0001). CONCLUSION LAA exclusion appears to reduce AF burden. The presence of AF triggers in the LAA appears to be the strongest predictor of AF reduction. The study underscores the role of the LAA in arrhythmogenesis for AF and highlights the complementary role of LAA exclusion in restoration of normal sinus rhythm.

Percutaneous left ventricular assist devices in ventricular tachycardia ablation: multicenter experience.

Background—Data on relative safety, efficacy, and role of different percutaneous left ventricular assist devices for hemodynamic support during the ventricular tachycardia (VT) ablation procedure are limited. Methods and Results—We performed a multicenter, observational study from a prospective registry including all consecutive patients (N=66) undergoing VT ablation with a percutaneous left ventricular assist devices in 6 centers in the United States. Patients with intra-aortic balloon pump (IABP group; N=22) were compared with patients with either an Impella or a TandemHeart device (non-IABP group; N=44). There were no significant differences in the baseline characteristics between both the groups. In non-IABP group (1) more patients could undergo entrainment/activation mapping (82% versus 59%; P=0.046), (2) more number of unstable VTs could be mapped and ablated per patient (1.05±0.78 versus 0.32±0.48; P<0.001), (3) more number of VTs could be terminated by ablation (1.59±1.0 versus 0.91±0.81; P=0.007), and (4) fewer VTs were terminated with rescue shocks (1.9±2.2 versus 3.0±1.5; P=0.049) when compared with IABP group. Complications of the procedure trended to be more in the non-IABP group when compared with those in the IABP group (32% versus 14%; P=0.143). Intermediate term outcomes (mortality and VT recurrence) during 12±5-month follow-up were not different between both groups. Left ventricular ejection fraction ⩽15% was a strong and independent predictor of in-hospital mortality (53% versus 4%; P<0.001). Conclusions—Impella and TandemHeart use in VT ablation facilitates extensive activation mapping of several unstable VTs and requires fewer rescue shocks during the procedure when compared with using IABP.

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;

Radiofrequency ablation of atrial fibrillation in patients with mitral or aortic mechanical prosthetic valves: A feasibility, safety, and efficacy study

BACKGROUND Patients with prosthetic valves have a high prevalence of atrial fibrillation (AF). We report a multicenter experience of performing pulmonary vein antral isolation (PVAI) in this challenging, high-risk cohort of patients. OBJECTIVE The purpose of this study was to assess the feasibility, safety, and efficacy of radiofrequency (RF) ablation for sinus rhythm restoration in AF patients with mitral or aortic mechanical prosthetic valves. METHODS A total of 50 patients with prosthetic valves (group I) who underwent RF ablation for AF between January 1, 2007, and April 30, 2009, were identified prospectively at four tertiary care centers. A matched group of 50 patients (group II) acted as controls. RESULTS Total procedural time (199.4 ± 49 minutes vs 166.6 ± 27.5 minutes, P <.001) and fluoroscopy time (60 ± 17 minutes vs 53.8 ± 6.8 minutes, P <.01) were prolonged, with a higher incidence of atrial flutter at 3 months in group I (18% vs 6%, P = .1) compared to group II. At 12 months, 80% of patients in the valve group were in sinus rhythm after an average of 1.3 procedures, and 82% of controls were in sinus rhythm after an average 1.2 procedures (P = .9). There was a trend toward a higher nonfatal complication rate in the valve group than in the control group (8% vs 4%, P = .1). CONCLUSION In patients with prosthetic valves, RF ablation for AF is feasible, safe, and efficacious, with a trend toward a higher nonfatal complication rate and an increased rate of postablation atrial flutter.

Effect of Atrial Fibrillation Ablation on Gastric Motility The Atrial Fibrillation Gut Study

Background—Collateral damage to the vagal nerve and the upper gastrointestinal (UGI) system during atrial fibrillation ablation has not been systematically evaluated. Methods and Results—We performed a prospective, observational study assessing the effect of atrial fibrillation ablation on the function of the vagus nerve/UGI system. All patients underwent esophageal manometry, gastric emptying study, and sham-feeding test (corresponding to esophageal, gastric, and small intestinal function evaluation, respectively) before ablation (baseline) and subsequently at 24 hours, 90 days, and 180 days after the procedure. In addition, UGI symptom assessment using the patient assessment of upper gastrointestinal disorders–symptom severity index (PAGI-SYM) questionnaire was performed at baseline and during each of the subsequent evaluations. Of the 27 patients enrolled in the study, 9 (33%) patients had abnormal UGI function at baseline; defined as at least one of the 3 abnormal tests. At 24 hours after the radiofrequency catheter ablation, 20 (74%) patients had at least 1 new abnormality on the UGI function tests (P<0.001). New onset esophageal dysmotility, delayed gastric emptying time, and abnormal sham-feeding tests were observed in 13 (48%), 13 (48%), and 9 (33%) patients, respectively. Mean PAGI-SYM scores increased from 7.78±6.6 at baseline to 15.56±13.4 (P=0.002) at 24 hours. New onset abnormalities persisted in 9 (33%) patients at 3 months and normalized in all patients at 6 months. Conclusions—Atrial fibrillation ablation results in functional impairment of the UGI system, including the esophagus, stomach, and small intestine. This impairment is transient and is probably mediated by the injury to the components of the vagal nerve. Clinical Trial Registration—URL: http://clinicaltrials.gov. Unique Identifier: NCT01396356.