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Purpose: Use of oral anticoagulation (OAC) in patients with a history of intracranial hemorrhage (ICH) is often considered high risk as OAC-related ICH is associated with high mortality rates. Left atrial appendage closure with a WATCHMAN device is an alternative management strategy to OAC to decrease thrombotic risk in atrial fibrillation patients; however use of OAC followed by dual antiplatelet therapy (DAPT) or DAPT therapy alone is required for 6 months post-procedurally. In this study, we examined the safety of WATCHMAN implantation followed by 6 months of anti-thrombotic therapy in patients with a history of ICH., Methods: This is a retrospective analysis of 63 patients with a history of ICH prior to WATCHMAN implantation (Group I) and 95 patients without a history of ICH who underwent WATCHMAN placement (Group II). The primary outcome was death, stroke, or major bleeding within 6 months of WATCHMAN placement., Results: The average CHA 2 DS 2 -VASc of Group I was 4.9 ± 1.7 vs 4.7 ± 1.4 for Group II (p = 0.34). The most common type of ICH in Group I was an intracerebral hemorrhage (57%). The median time between ICH and WATCHMAN implantation in Group I patients was 212 days. A total of 19% of Group I patients were managed with DAPT alone post-procedurally vs. 3% in Group II (p < 0.001). Similar to 89% of Group II (p = 0.19), 95% of Group I patients were free of the primary outcome at 6 months. No Group I patients had recurrent ICH within 6 months after WATCHMAN implantation., Conclusion: In a retrospective, multicenter series of patients with a history of ICH prior to WATCHMAN implantation, WATCHMAN placement was performed safely with 6-month outcomes that were similar to patients without a history of ICH, encompassing the time during which a patient with a history of ICH would need antithrombotic therapy to facilitate WATCHMAN placement.

Background: Warfarin is deemed safe compared to bridging with heparin in the peri-procedure setting while implanting cardiac devices. The timing of discontinuation and re-initiation of direct anticoagulant agents (DOACs) such as dabigatran, apixaban, and rivaroxaban in the peri-procedural setting in comparison to warfarin is not well studied., Objective: We wanted to compare three DOAC agents with warfarin during cardiac device implantation., Methods: Consecutive patients on treatment with dabigatran, rivaroxaban, or apixaban (group A) undergoing a cardiac device generator change, upgrade, or new implantation procedure were compared to those on warfarin (group B). Incidence of hematoma, infection, effusion, stroke, and other complications were noted at 1 day, 1 week, and 3 months., Results: A total of 311 patients in group A underwent the above procedures with 73 patients on dabigatran, 153 on rivaroxaban, and 85 on apixaban. There were 467 patients on warfarin in group B. Mean age of the total population was 68 ± 12 years with 67% males and > 80% Caucasians. The last dose of the DOAC was the night prior to the procedure and resumed the night of the procedure (single dose interruption for apixaban and dabigatran and no un-interruption for rivaroxaban). There was no difference noted in the incidence of minor or major hematoma (9% vs 8.5%, p = 0.7). No stroke occurred in either group., Conclusion: Use of DOAC agents with transient interruption of one dose is as safe as warfarin in the peri-procedural setting during implantation of cardiac devices.

Background: Electrical isolation of the left atrial appendage (LAA) may provide incremental benefits for arrhythmia management in patients undergoing radiofrequency ablation (RFA) for persistent atrial fibrillation (AF)., Objective: The aim of this study was to compare efficacy and safety of endocardial ablation and LAA exclusion with LARIAT device for electrical and mechanical exclusion of LAA., Methods: We compared patients who underwent endocardial LAA isolation during index RFA for persistent AF and underwent a repeat RFA to patients who underwent LAA exclusion with LARIAT device followed by RFA for AF in this multicenter registry. Efficacy of electrical and mechanical isolation of LAA was assessed., Results: We included 182 patients of which 91 patients underwent endocardial LAA isolation during RFA for AF, and 91 patients underwent LAA exclusion with LARIAT device followed by RFA for AF. Baseline characteristics were similar except for higher CHA 2 DS 2- VASc score, coronary artery disease, and prior stroke rate in LARIAT arm. Persistence of electrical isolation (measured at beginning of second procedure) after LARIAT procedure was higher than one-time AF-RFA (96.7% vs 52.8%, p < 0.01). Acute pulmonary vein isolation rates were similar in both arms. AF recurrence rate after second isolation attempts at 1 year was similar in both arms. No difference in major complications was noted between both arms., Conclusions: LAA exclusion with LARIAT device appears to be more efficacious as compared to one-time endocardial ablation, but not compared to repeat isolation, in achieving complete electrical isolation of LAA for persistent AF.

Purpose: In patients who undergo implantable cardiac defibrillator (ICD) implantation for primary prevention of sudden cardiac death (SCD), data is unclear whether their ICD generator needs to be replaced at end of life if their left ventricular ejection fraction (EF) improves. Despite improvement in EF, the underlying scar may represent a potential substrate for ventricular arrhythmias., Methods: Data on 280 patients who underwent ICD implantation for primary prevention of SCD was obtained from two centers. Patients were followed for any improvement in EF to ≥35%. All arrhythmic events during follow-up, including appropriate and inappropriate shocks/ATP, were recorded., Results: Thirty percent (n = 86/280) of patients improved their EF to >35% of which 41% (n = 37) underwent a generator change by the study ending period with the rest not yet at ERI. Mean baseline EF in patients with and without target EF improvement was 26 ± 7 and 23 ± 7% (p = 0.2). After excluding patients whose arrhythmic events data were unavailable, the final sample consisted of 62 patients in the EF improvement group and 156 patients in the group without EF improvement. In the group with EF improvement, appropriate events (shock + ATP) were noted in 19% of patients (n = 12/62) and inappropriate shocks and ATP in 6% of (n = 4/62) patients after their EF improved to >35%. Four patients received appropriate therapies when their EF was low prior to improvement. In contrast, in patients who had no improvement in EF, 27% (n = 43/156) received an appropriate therapy (p = 0.6) while 11% (n = 18/156) (p = 0.2) received inappropriate shocks and ATP. All-cause mortality was higher in patients without subsequent improvement in EF versus those with EF improvement (31 vs. 15% (p = .005)., Conclusions: There was no significant difference in the number of appropriate therapies received by each group. Patients continue to be at high risk for sudden cardiac death despite improvement in EF.

Purpose: The left atrial appendage (LAA) is a well-known source of atrial natriuretic peptide (ANP) and therefore plays an important role in homeostasis. The neurohormonal impact of epicardial exclusion of the LAA with the LARIAT procedure is unknown. In this proof-of-concept study, we postulated that LAA exclusion would impact homeostasis as evidenced by changes in electrolytes and blood pressure (BP)., Methods: A total of 76 patients who underwent successful LAA exclusion were enrolled in this retrospective observational study utilizing a prospective registry. Electrolytes, BP, and heart rate (HR) were monitored before LARIAT and post-LARIAT (24 and 72 h and 6 months)., Results: There was a significant reduction of systolic BP (mmHg) at 24 h (113.3 ± 16.0; p < 0.0001) and 72 h (119.0 ± 18.4 mmHg; p < 0.0001) post-LARIAT when compared with pre-LARIAT BP (138.2 ± 21.3). The reduction in systolic BP persisted at 6-month follow-up (128.8 ± 17.3; p = 0.0005). There was significant reduction in serum sodium (mmol/L) at 24 h (135.4 ± 3.6; p < 0.0001) and 72 h (136.3 ± 3.7; p < 0.001) post-LARIAT when compared to pre-LARIAT (138.7 ± 3.2). The reduction in sodium was not persistent at 6-month follow-up (138.4 ± 3.3; p = 0.453)., Conclusions: LAA exclusion results in an early and persistent decrease in systolic BP. Additionally, there is an early decline in serum sodium, which normalizes at long-term follow-up. The underlying mechanism leading to these changes is not entirely clear; however, it is likely related to neurohormonal changes post LAA exclusion.

Background: Neurocardiogenic syncope (NCS) is a common clinical condition characterized by abrupt cardiovascular autonomic changes resulting in syncope. This is a recurring condition with mixed results from current strategies of treatment., Methods: Subjects with a diagnosis of NCS were screened and enrolled. All the participants were given a DVD containing yoga videos and were instructed to practice yoga therapy for 60 min, three times a week for 3 consecutive months. Syncope functional status questionnaire score (SFSQS) was administered at the beginning and the end of the study. The subjects were followed for 3 months and underwent repeat tilt table testing at the end of the study., Results: Of the 60 patients screened, 44 subjects were enrolled, 21 in the intervention group and 23 in the control group. Most of the participants were females, and the mean age was 21 ± 3 years. In the intervention group, who finished the yoga regimen, there was a statistically significant improvement from control phase to the intervention phase, in number of episodes of syncope (4 ± 1 vs 1.3 ± 0.7, p < 0.001) and presyncope (4.7 ± 1.5 vs 1.5 ± 0.5, p < 0.001). The mean SFSQS also decreased from 67 ± 7.8 to 29.8 ± 4.6 (p < 0.001). All subjects had positive head up tilt table (HUTT) study at the time of enrollment compared to only six patients at the completion of intervention phase (10/100 vs 6/28 %, p < 0.0001)., Conclusion: Yoga therapy can potentially improve the symptoms of presyncope and syncope in young female patients with NCS.

Background: The prevalence and predictors of atrial tachyarrhythmias (ATa) in patients with pulmonary hypertension (PH) is less well understood., Methods: We performed a retrospective study including 311 patients with PH, confirmed by right heart catheterization in our center between 2007 and 2011. Baseline characteristics, clinical, echocardiographic, and hemodynamic data were collected and compared between patients with and without ATa., Results: The mean age was 61 ± 13 years with 64 % females. The mean pulmonary artery pressure (mPAP) was 46 ± 20 mmHg, mean left ventricular ejection fraction (LVEF) was 55 ± 13 %, and mean pulmonary capillary wedge pressure (PCWP) was 19 ± 9 mmHg. Of the 311 patients with PH, 121 (39 %) patients had ATa. Patients with ATa were older (p<0.001) and were more likely to have systemic hypertension (p=0.03), diabetes (p=0.015), coronary artery disease (p<0.001), heart failure (p<0.001), mitral regurgitation (p=0.001), impaired LVEF (p=0.02), and left atrial enlargement (p<0.001). There was no difference in the prevalence of ATa in mild, moderate, or severe PH. The mean PCWP was higher in patients with ATa (17.9 ± 9 vs 20.3 ± 8; p=0.022). In multivariate analysis using Cox-proportional hazard model, the independent predictors of mortality were age (HR 1.05; p=0.003), coronary artery disease (HR 2.34; p=0.047), LVEF (HR 0.793; p=0.023), and mPAP (HR 1.023; p=0.003)., Conclusion: ATa are common in patients with PH. Left heart disease, left atrial enlargement, and elevated PCWP but not right atrial enlargement or mPAP predict the occurrence of ATa in patients with PH.

Background: Pre- and postablation atrial fibrillation (AF) brain natriuretic peptide (BNP) levels were shown to predict increased recurrence of AF following ablation., Objective: Our objective was to assess whether elevated BNP levels merely represent the presence of AF at the time of measurement or indeed the true recurrence of AF., Methods and Results: In a prospective study of 88 patients undergoing AF ablation, BNP levels were measured immediately before, after, 24 h, and 4-6 months postablation. BNP levels were stratified by presenting rhythm and ventricular rate at the time of measurement. Median BNP level preablation was higher in patients presenting in AF compared to sinus rhythm (SR) (54(44-79) pg/ml vs. 30(18-47) pg/ml, p < 0.001). Postablation restoration of SR in patients presenting in AF reduced median BNP levels from 54(44-79) pg/ml to 40(37-51) pg/ml, (p < 0.001). However, no change was noted in patients who presented in and maintained SR throughout the procedure (30(18-47) pg/ml to 27(16-40) pg/ml, p = 0.270). At 4-6 months, BNP measured in patients in SR was not significantly different from postablation BNP (35(22-53) pg/ml vs. 38(20-52) pg/ml, p = 0.656), although 35% of them had AF recurrence in 1-year follow-up. Median BNP level measured in five patients while in atrial arrhythmia was elevated compared to postablation BNP (464(421-464) pg/ml to 37(36-37) pg/ml, p = 0.043). BNP levels and ventricular rates are positively correlated at all times pre- and postablation., Conclusions: BNP level rises acutely during AF and with rapid ventricular rates. BNP level seems to be a function of atrial rhythm and ventricular rate rather than short- or long-term predictor of AF ablation success.

Introduction: While early postoperative atrial fibrillation (post op AF) following valve and coronary artery bypass surgery is a known common cause of increased morbidity and mortality, the late recurrence of AF long term in this group of patients has not been well studied., Objective: The objective of this study was to assess the late recurrence and predictors of AF in patients undergoing open heart surgery., Methods: From a prospective cardiovascular surgery registry, 519 patients with no prior history of AF who underwent open heart surgery for cardiac bypass/valvular surgeries between May 2000 and April 2004 were followed until May 2009. A Cox proportional hazards model was used to assess the impact of early post op AF on the long-term AF after adjusting for significant covariates, Results: Of these patients, 25.6 % (133) had early (0-3 months) post op AF (group A). The remainder of patients were considered as controls (group B, n = 386). Late occurrence of AF (3-84 months) was 5.3 % (n = 28) after a mean follow up duration of 5 ± 1.9 years. The late occurrence of AF in group A (recurrent AF) was significantly higher than in group B (11 vs 3 % n = 15 vs 13, p = 0.0002). Early postoperative AF was a significant predictor of late recurrence of AF in multivariate analysis (hazard ratio (HR) 3.9, CI 1.8-8.4, p = 0.0003). Group A also had higher mortality compared to group B (21 vs 13 %, n = 28 vs n = 51, p = 0.003) with early postoperative AF showing a trend towards higher mortality on multivariate analysis (HR 1.7, p = 0.06)., Conclusions: Late recurrence of AF is higher than was previously thought to be in patients experiencing early post operative AF with a trend towards higher long-term mortality. Post op AF should not be dismissed as a benign entity and these patients should be followed closely.

Background: Radiation exposure in the electrophysiology (EP) lab is a major concern to most electrophysiologists. A new technology, MediGuide™ nonfluoroscopic catheter tracking system, has been used for the first time in the USA recently. We intended to evaluate the efficacy of this novel catheter tracking system in reducing radiation exposure., Methods: We performed a prospective observational study by comparing the radiation exposure with MediGuide™ system to that of conventional mapping systems. The first 45 EP procedures performed with the MediGuide™ system were compared to 45 matched patients undergoing similar procedures during the same time frame using conventional mapping systems (CARTO and NavX) and fluoroscopy. We collected and compared baseline characteristics, procedural variables including fluoroscopic exposure between both groups., Results: Forty-five patients underwent EP procedures using the MediGuide™ technology. They were matched with an equal number of patients with conventional mapping systems. Of the 45 patients included in the study, 33 underwent right atrial flutter ablations, 5 underwent atrioventricular nodal reentrant tachycardia ablations, 4 underwent ablation of Wolf-Parkinson-White syndrome, and 3 underwent EP studies with no ablation. There were no differences in mean age, gender distribution, and body mass index between the groups. Procedure duration in the MediGuide™ group was significantly lower than the duration in the conventional group (103 vs. 142 min, p = 0.03). The fluoroscopic time was significantly less during the procedures performed with the MediGuide™ technology when compared to the control group (8 vs. 21 min, p < 0.001). No major complications occurred during the procedures in either group., Conclusion: MediGuide™, a new nonfluoroscopic catheter tracking system, is associated with more than a 50 % reduction in fluoroscopic time when compared to conventional mapping systems.

Purpose: An association between atrial fibrillation (AF) and gastroesophageal reflux disease (GERD) and/or irritable bowel syndrome (IBS) is increasingly being identified; yet the role of radiofrequency catheter ablation (RFA) of AF has not been systematically evaluated in these patient populations., Methods: We performed a prospective matched case-control study of AF patients with GERD and/or IBS who underwent RFA for AF in two centers in North America. AF patients with GERD and/or IBS (gastrointestinal [GI] group) were matched by age, gender, and type of AF at each of the centers with an equal number of AF patients without GERD or IBS (non-GI group)., Results: Sixty patients were included in the study with 30 in each group. Mean age of the population was 45 years with 14 (47 %) males and 21 (87 %) patients with paroxysmal AF in each group. More patients in the GI group had identifiable GI triggers for AF episodes. During RFA, more patients in the GI group had a "vagal response" compared to non-GI group (60 vs 13 %; p < 0.001). Left atrial scar as identified by electroanatomical mapping was more common in patients in the non-GI group compared to the GI group (57 vs 27 %; p = 0.018). At 1-year follow-up, 56 (93 %) of the patients were free from AF with no difference between both groups., Conclusions: Majority of AF patients with GERD and/or IBS have triggered AF and a positive vagal response during RFA. RFA is equally effective in this patient population when compared to those without GERD or IBS.

Purpose: Access-related neuropathy after atrial fibrillation (AF) ablation is underappreciated. We intend to describe the incidence, management, and prognosis of postprocedural neuropathy after AF ablation., Methods: We performed a retrospective analysis of all consecutive patients with postprocedural neuropathy who underwent AF ablation in three high-volume tertiary care hospitals between January 2007 and April 2011., Results: Of the 3,128 patients who underwent AF ablation during the study period, 25 (0.8 %) patients had postprocedural neuropathy and were included in the current study. Mean age was 58.5 ± 11.5 years with 18 (72 %) being males and 14 (56 %) having paroxysmal AF. Ulnar nerve, lateral femoral cutaneous nerve manifesting as meralgia paresthetica, and femoral nerve were involved in 5 (20 %), 13 (54 %), and 7 (26 %) of the patients, respectively. Majority of neuropathies were associated with periprocedural hematomas (19, 76 %), and a quarter (19/72, 26 %) of all hematomas were associated with neuropathy. Initial treatment included warm and cold compresses followed by nonsteroidal anti-inflammatory and narcotic pain medications. In addition to the above regimen, in some patients (11, 44 %), oral gabapentin was used and it was associated with a shorter time to symptom resolution (9.4 vs. 14.1 days, p = 0.007). All patients were symptom free within 90 days of the procedure., Conclusion: Postprocedural neuropathy after AF ablation is rare and is frequently associated with a periprocedural hematoma. Patients typically become symptom free within 90 days of the procedure, and gabapentin may have a role in earlier symptom resolution.