Yeruva Madhu Reddy

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.

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.

Atrial fibrillation and the risk of incident dementia: A meta-analysis

BACKGROUND The risk of cerebrovascular embolic events with atrial fibrillation (AF) is potentially linked to an increased risk of cognitive decline and dementia. However, epidemiologic studies exploring the association between AF and incident dementia have reported conflicting results. OBJECTIVE The purpose of this study was to perform a meta-analysis of observational studies specifically designed to evaluate the prospective relationship between AF and incident dementia. METHODS We searched PubMed, CENTRAL, BioMedCentral, Embase, Cardiosource, clinicaltrials.gov, and ISI Web of Science (January 1980 to May 2012). No language restriction was applied. Two independent reviewers screened titles and abstracts to identify population-based studies that prospectively evaluated the association between AF and the incidence of dementia in patients not suffering an acute stroke and with normal cognitive function at baseline, providing the hazard ratio (HR) obtained in multiple Cox regression analyses, and adjusted for all confounding variables. Two independent reviewers assessed risk of bias according to the Cochrane Collaboration, and extracted patient and study characteristics and the adjusted HR of incident dementia with its 95% confidence interval (CI) of patients with AF vs those without AF. RESULTS Eight studies with 77,668 patients were included in the analysis. All studies had a prospective observational design and included elderly patients (mean age range 61-84 years) with normal cognitive function at baseline, of whom 11,700 (15%) had AF. After a mean follow-up of 7.7 ± 9.1 years (range 1.8-30 years), 4773 of 73,321 (6.5%) patients developed dementia. Two studies did not report the rates of dementia at follow-up but reported the adjusted HR and were included in the pooled analysis. At pooled analysis adjusted for baseline confounders and covariates, AF was independently associated with increased risk of incident dementia (HR = 1.42 [95% CI 1.17-1.72], P <.001). CONCLUSION AF is independently associated with increased risk of dementia. Patients with AF should be periodically screened for dementia, which should be included among the outcomes assessed in AF treatment trials.

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.

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.

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.

The role of percutaneous left ventricular assist devices during ventricular tachycardia ablation

Ventricular tachycardia (VT) is a common but serious arrhythmia that significantly adds to the morbidity and mortality of patients with structural heart disease. Percutaneous catheter ablation has evolved to be standard therapy to prevent recurrent implantable cardioverter defibrillator shocks from VT in patients on antiarrhythmia medications. Procedural outcomes in patients with structural heart disease are often limited by haemodynamically unstable VT. Although substrate- and pace-mapping techniques have become increasingly popular for VT ablation, these approaches can often times may not address inducible clinical and non-clinical VTs. Activation and entrainment mapping can help the operator target VT exit sites in a precise fashion minimizing the amount of radiofrequency ablation needed for a successful ablation. An evolving alternative strategy that allows induction and mapping of VT in the setting of severe cardiomyopathy and haemodynamic instability is through maintaining perfusion with a percutaneous ventricular assist device (pVAD). This review will discuss these pVAD technologies, distinguish technical applications of use, highlight the published clinical experience, provide a clinical approach for support device selection, and discuss use of these technologies with current mapping and navigational systems.

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.

The Effect of Atrial Fibrillation Ablation on Gastric Motility "The AF 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.

Delayed Lead Perforation: Can We Ever Let the Guard Down?

Lead perforation is a major complication of cardiac rhythm management devices (CRMD), occurring in about 1%. While most lead perforations occur early, numerous instances of delayed lead perforation (occurring >30 days after implantation) have been reported in the last few years. Only about 40 such cases have been published, with the majority occurring <1 year after implantation. Herein, we describe the case of an 84-year-old female who presented with recurrent syncope and was diagnosed to have delayed pacemaker lead perforation 4.8 years after implantation. Through this report, we intend to highlight the increasing use of CRMD in elderly patients, and the lifelong risk of complications with these devices. Presentation can be atypical and a high index of suspicion is necessary for diagnosis.