Feasibility, safety, and efficacy of a novel external compression vascular closure device: The LockeT® study.

INTRODUCTION: Hemostasis following large-bore femoral vein access remains a challenge. Manual compression has been the standard of care but requires bedside staff, prolonged bed rest, and longer length of stay. The LockeT is an external compression device that attempts to address these issues while achieving venous hemostasis. OBJECTIVES: We evaluate postprocedural hemostasis and vascular closure outcomes after using LockeT following cardiac electrophysiologic procedures. METHODS: We performed a single-center, observational study of patients who underwent vascular closure for electrophysiology procedures using LockeT. Postprocedural outcomes were subsequently analyzed. RESULTS: We studied 102 patients (N) for whom LockeT was used to close 182 separate vascular access sites (n). Common procedures were atrial fibrillation ablation (56.9%, N = 58) and left atrial appendage occlusion (28.4%, N = 29). Most often, 8-Fr [48.3% (n = 126)], 11-Fr [27.2% (n = 71)], and 8.5-Fr [16.9% (n = 44)] sheaths were used, with an average procedure time of 82.1 ± 29.4 min. Hemostasis was achieved in 97.8% (n = 187) of all LockeT cases. Time to ambulation and discharge were 3.93 ± 1.10 h and 8.1 ± 4.4 h, respectively. No major complications were noted. Postprocedurally, 52% (N = 53) of patients were discharged on the same day. There were no differences in hemostasis (p = .859) or ambulation times (p = .202) between procedure types. CONCLUSION: The LockeT can effectively close venous access sites with no major complications.

Comparison of peri-procedural anticoagulation with rivaroxaban and apixaban during radiofrequency ablation of atrial fibrillation.

INTRODUCTION: Prospective studies on rivaroxaban and apixaban have shown the safety and efficacy of direct anticoagulation agents (DOAC)s used peri-procedurally during radiofrequency ablation (RFA) of atrial fibrillation (AF). Studies comparing the two agents have not been performed. METHODS: Consecutive patients from a prospective registry who underwent RFA of AF between April 2012 and March 2015 and were on apixaban or rivaroxaban were studied. Clinical variables and outcomes were noted. RESULTS: There were a total of 358 patients (n = 56 on apixaban and n = 302 on rivaroxaban). There were no differences in baseline characteristics between both groups. The last dose of rivaroxaban was administered the night before the procedure in 96% of patients. In patients on apixaban, 48% of patients whose procedure was in the afternoon took the medication on the morning of the procedure. TIA/CVA occurred in 2 patients (0.6%) in rivaroxaban group with none in apixaban group (p = 0.4). There was no difference in the rate of pericardial effusion between apixaban and rivaroxaban groups [1.7% vs 0.6% (p = 0.4)]. Five percent of patients in both groups had groin complications (p = 0.9). In apixaban group, all groin complications were small hematomas except one patient who had a pseudoaneurysm (1.6%). One pseudo-aneurysm, 1 fistula and 3 large hematomas were noted in patients on rivaroxaban (1.7%) with the rest being small hematomas. DOACs were restarted post procedure typically 4 h post hemostasis. CONCLUSIONS: Peri-procedural uninterrupted use of apixaban and rivaroxaban during AF RFA is safe and there are no major differences between both groups.

Replacing warfarin with a novel oral anticoagulant: Risk of recurrent bleeding and stroke in patients with warfarin ineligible or failure in patients with atrial fibrillation (The ROAR study).

BACKGROUND: A significant proportion of patients treated with warfarin for atrial fibrillation (AF) become warfarin ineligible (WI) due to major bleeding events (MBE) or systemic thromboembolism (STE). We report a large multicenter real-world experience of the use of direct oral antagonists (DOACs) in these WI patients. METHODS: We report the outcomes of 263 WI patients treated with DOACs. The primary objective was to evaluate clinical outcomes of STE and MBE with DOACs. Secondary objective was to assess clinical predictors of repeat MBE and STE on DOACs. RESULTS: Note that 63% (166 of 263) patients had a repeat MBE on DOACs. Repeat MBE was significantly higher in patients with prior gastrointestinal bleeding (74.5% vs. 30%, P < 0.0001). Five percent (12 of 263) developed repeat STE. Higher mean CHA2DS2VASC (6.5 ± 1.7 vs. 3.3 ± 1.6 = 0.001) score was associated with repeat STE. About 34% (57 of 166) of patients had an intervention to manage repeat MBE. LAAO devices were successfully used in 67% (12 of 18) high-risk patients who underwent major interventions to manage MBE. CONCLUSION: In WI patients rechallenged with DOACs, a significant proportion developed repeat MBE. LAAO devices seem reasonable in those patients who undergo major interventions to manage MBE with cautious and temporary continuation of DOAC.

Catheter Ablation for Atrial Fibrillation in Patients With Watchman Left Atrial Appendage Occlusion Device: Results from a Multicenter Registry.

BACKGROUND: There have been an increasing number of atrial fibrillation (AF) patients with Watchman left atrial appendage occlusion (LAAO) device, requiring catheter ablation (CA) for maintenance of normal sinus rhythm. In this study, we describe our experience with the feasibility and safety of CA in patients with a preexisting Watchman LAAO device. METHODS: This was a retrospective multicenter AF registry of 60 patients with Watchman LAAO device who underwent CA for AF. Baseline clinical and procedural characteristics of the included subjects were retrieved from review of medical records and were analyzed. RESULTS: The mean age was 72.7 ± 4.9 years and the mean CHADS2 score was 2.3 ± 0.6. All patients had successful pulmonary vein isolation (PVI). The left atrial appendage (LAA) was electrically active in 34 (56%) while reentrant tachycardia and AF triggers were seen in 17 (28%) patients. Electrical isolation was attempted in these 17 patients with only 10 achieving complete LAA isolation. Repeat imaging showed new peri-device leaks in 30% (12/40) patients, while new significant peri-device leaks (≥5 mm) were noted in 10% (10/40) of patients after RFA, respectively, requiring continuation of oral anticoagulation. There were a higher proportion of patients with severe peri-device leaks (≥5 mm) after LAA isolation. However, >50% of those leaks sealed off on follow-up transesophageal echocardiogram. CONCLUSION: AF ablation is a feasible and safe in patients with preexisting Watchman LAAO device. Electrical isolation of the LAA could be difficult and when attempted can result in increased risk of short-term peri-device leak and recurrence of AT/AF in almost all patients.

Partial Brain Tissue Oxygen Levels Predict Arrhythmia and Prognosis in Patients With Brain Injury.

The objective of this study was to examine the clinical determinants of incidence and prognosis of arrhythmias in the setting of acute brain injury. Acute brain injury is known to cause electrocardiographic abnormalities and cardiac arrhythmias. The relation between partial brain tissue oxygen (PBTO) and intracranial pressure (ICP) with arrhythmia incidence and prognosis remains unknown. Consecutive patients with acute brain injury and intracranial bleed admitted to the neurosurgical intensive care unit were enrolled in the study. Baseline characteristics [demographics, medical history, etiology of brain injury, Glasgow Coma Scale (GCS) score, blood pressure, and respiratory rate] were documented. Patient's telemetry recordings were reviewed for daily mean heart rates and arrhythmias. If arrhythmia was noted, PBTO levels at the beginning of arrhythmia, ICP, brain tissue temperature, and outcomes were recorded. A total of 106 subjects (53% men, age 39 ± 18 years, 65 traumatic and 41 nontraumatic brain injuries) were studied. Overall, 62% of subjects developed a total of 241 arrhythmia episodes. Ventricular arrhythmias were associated with significantly higher daily mean heart rates, low PBTO levels, and low GCS scores, whereas atrial arrhythmias were associated with lower daily mean heart rates, normal PBTO levels, and higher GCS and ICP. Three or more episodes of arrhythmia predicted worse outcomes, including mortality (P = 0.001). In patients with acute brain injury, poor PBTO levels are associated with higher incidence of ventricular tachyarrhythmias. In contrast, atrial tachyarrhythmias occur in patients with normal PBTO levels and higher ICP. Incidence of ventricular arrhythmia in those with poor PBTO is associated with increased mortality.

Characterization of pleural effusion after left atrial appendage exclusion using the Lariat procedure.

BACKGROUND: The Lariat procedure is increasingly used for the exclusion of the left atrial appendage (LAA) in atrial fibrillation (AF) patients. There are anecdotal reports of pleural effusions after the Lariat procedure. However, the incidence, demographics, and pathophysiology of these effusions are largely unknown. OBJECTIVE: Characterization of pleural effusions in patients who underwent LAA exclusion using the Lariat procedure. METHODS: We report the incidence, demographics, and clinical and laboratory characteristics of patients from a multicenter prospective registry who underwent the Lariat procedure and subsequently developed pleural effusions. RESULTS: A total of 10 out of 310 (3.2%) patients developed significant pleural effusions after the Lariat procedure. The mean age of these patients was 67 ± 9, ranging from 52 to 78 years and included 5 (50%) males. Nine patients had persistent AF with median CHADS2 score of 2.7 ± 1.2. The LAA was successfully ligated in all these patients. Post-Lariat procedure, 6 patients developed bilateral and 4 patients developed left-sided pleural effusions. Pleural tap revealed transudative in 2 and exudative in 6 patients. The remaining 2 patients responded to active diuresis and behaved clinically like transudative effusions. There is a statistically significant difference between the onset of pleural effusion after the Lariat procedure between tPLE versus ePLE groups (14 ± 1.2 vs. 6 ± 6, P = 0.05). CONCLUSION: Incidence of clinically significant pleural effusion is uncommon after the Lariat procedure and can be either exudative or transudative in nature depending on the underlying mechanisms. More prospective studies are needed to study the pathophysiologic basis of development of pleural effusions after the Lariat procedure.

Pulmonary vein isolation for atrial fibrillation in the postpneumonectomy population: a feasibility, safety, and outcomes study.

BACKGROUND: Pulmonary vein isolation (PVI) of the remnant pulmonary vein (PV) stumps in pneumonectomy patients has not been well characterized. METHODS: This is a multicenter observational study of patients with a remnant PV stump after pneumonectomy. Consecutive patients with a history of pneumonectomy and who had undergone RF ablation for drug refractory AF were identified from the AF database at the participating institutions. RESULTS: There were 15 patients in whom pneumonectomy was performed, for resection of tumors in 10, infection in 4, and bullae in 1 patient and who underwent RF ablation for AF. The mean age was 63 ± 7 years. The stumps were from the right lower PV in 5, left upper PV in 5, left lower PV in 3, and right upper PV in 2 patients. All the PV stumps were electrically active with PV potentials and 9 (60%) of them had triggered activity. PVI was performed in 14 and focal isolation in 1 patient. At 1-year follow-up, 80% were free of AF, off of antiarrhythmic medications. CONCLUSION: PV stumps in AF patients with previous pneumonectomy are electrically active and are frequently the sites of active firing. Isolation of these PV stumps can be accomplished safely and effectively using catheter ablation with no practical concern for PV stenosis or compromising PV stump integrity.

Under-Utilization of Implantable Cardioverter Defibrillators in Patients with Heart Failure - The Current State of Sudden Cardiac Death Prophylaxis.

BACKGROUND: Despite ACC/AHA guidelines indicating implantable cardioverter defibrillator (ICD) as class I therapy for primary prevention of sudden cardiac death in patients with EF≤35%, ICD utilization rates in real world practice have been low. OBJECTIVE: To determine the rate of ICD implantation at a tertiary care academic center and to assess the reasons for under-utilization of the same. METHODS: Review of a prospectively collected database which included all patients diagnosed with an EF≤35% was performed to assess the rate of ICD implantation and mortality. Reasons for non-implantation of ICD were then assessed from detailed chart review. RESULTS: A total of 707 patients (age 69.4 ± 14.1 years) with mean EF of 26±7% were analyzed. Only 28% (200/707) of patients had ICDs implanted. Mortality was lower in the group with ICD (25% vs 37%, p=0.004). When patients who either died or were lost to follow-up prior to 2005 were excluded, ICD utilization rate was still low at 37.6%. The most common reason for non-implantation of ICD was physicians not discussing this option with their patients. Patient refusal was the second most common reason. CONCLUSIONS: ICD Implantation rates for primary prevention of SCD in patients with EF≤35% is low. Physician and patient education should be addressed to improve the utilization rates.

Radiofrequency ablation of drug refractory ventricular tachycardia related to cocaine use: a feasibility, safety, and efficacy study.

BACKGROUND: Cocaine use is a known but rare cause of cardiac arrhythmias. Ventricular arrhythmias related to cocaine may not respond to antiarrhythmic drugs and may need treatment with radiofrequency ablation. OBJECTIVES: We describe the clinical and electrophysiological characteristics of cocaine-related ventricular tachycardia (VT) from a multicenter registry. METHODS: Subjects presenting with VT related to cocaine use and being considered for radiofrequency ablation have been included in the study. Patients who were refractory to maximal medical therapy underwent radiofrequency ablation of the VT. Clinical, procedural variables, efficacy, and safety outcomes were assessed. RESULTS: A total of 14 subjects met study criteria (age 44 ± 13, range 18- to 68-year-old with 79% male, 71% Caucasian). MRI showed evidence of scar only in 43% of patients (6/14). The mechanism of VT was focal in 50% (n = 7) and scar related reentry in 50% (n = 7) based on 3D mapping. The mean VT cycle length was 429 ± 96 milliseconds. The site of origin was epicardial in 16% (3/18) of VTs. Most clinical VTs were hemodynamically stable (75%). Mean ejection fraction at the time of admission was 44 ± 14%. Duration of procedure was 289 ± 50 minutes. One subject developed pericardial tamponade requiring drainage. At 18 ± 11 months follow-up, freedom from arrhythmia was seen in 86% (1 case lost to follow-up and 2 died). CONCLUSION: Radiofrequency ablation is not only feasible but also safe and effective in patients who have drug refractory VT related to chronic cocaine use.

The impact of atrial fibrillation and its treatment on dementia.

Atrial fibrillation (AF) is a very common tachyarrhythmia and is becoming increasingly prevalent, while dementia is a neurological condition manifested as loss of memory and cognitive ability. Both these conditions share several common risk factors. It is becoming increasingly evident that AF increases the risk of dementia. There are several pathophysiological mechanisms by which AF can cause dementia. AF increases the stroke risk and strokes are strongly associated with dementia. Besides stroke, altered cerebral blood flow in AF and cerebral microbleeds from anticoagulation may enhance the risk of dementia. Maintaining sinus rhythm may therefore decrease this risk. Catheter ablation is emerging as an effective alternative to maintain patients in sinus rhythm. This procedure has also shown promise in decreasing the risk of all types of dementia. Besides maintaining sinus rhythm and oral anticoagulation, aggressive risk factor modification may reduce the likelihood or delay the onset of dementia.

Impedance changes on defibrillation coils after atrial fibrillation ablation: lead damage or electromechanical interference?

Fluctuation of impedance on defibrillator leads is highly suggestive of lead failure. A drop in impedance is associated with insulation defects while high impedance is suggestive of lead fracture. In this case report, we described a patient where electromagnetic interference from radiofrequency ablation near the site of superior vena cava coil caused the sensed impedance to fluctuate without uneventful outcomes and we discussed the possible mechanism. Both electromagnetic interference and defibrillator lead insulation defect can result in low threshold and inappropriate shocks. Sometimes electromagnetic interference may result in physical damage of the implanted system and may result in subsequent fluctuations in impedance. Awareness of electromagnetic interference that can cause fluctuating impedance without structural damage can help in making appropriate diagnosis and may avoid unnecessary procedures.

Peri-procedural use of direct anticoagulation agents during cardiac device implantation: vitamin K antagonists vs direct oral anticoagulants.

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.

Safety and efficacy of leadless pacemaker for cardioinhibitory vasovagal syncope.

BACKGROUND: Single-chamber leadless pacemakers (LPs) have been shown to be an effective alternative to conventional transvenous pacemakers (CTPs), but their benefit in the context of cardioinhibitory vasovagal syncope (CI-VVS) is unknown. OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of LP compared with dual-chamber CTP for CI-VVS. METHODS: We conducted a multicenter, retrospective study comparing patients who received LP or dual-chamber CTP for drug-refractory CI-VVS. CI-VVS was diagnosed clinically and supported by cardiac monitoring and head-up tilt table testing. The primary efficacy endpoint was freedom from syncope during follow-up. Secondary endpoints included device efficacy and safety estimated by device-related major and minor adverse events (AEs). RESULTS: Seventy-two patients (24 LP, 48 CTP; age 32 ± 5.5 years; 90% female; syncope frequency 7.6 ± 3.4 per year) were included. At 1 year, 91% of patients (22/24) in the LP group and 94% of patients (43/48) in the CTP group met the primary efficacy endpoint (P = .7). Device efficacy endpoint was met in 92% of the LP group and 98% of the CTP group (P = .2). Early major AEs occurred in 2 of 24 in the LP group and 3 of 48 in the CTP group (P = .4). Late major AEs occurred in 0 of 24 in the LP group and 2 of 48 in the CTP group (P = 1). CONCLUSION: In patients with CI-VVS, single-chamber LP demonstrated equivalent efficacy in reducing syncopal events compared to dual-chamber CTP, with a similar safety profile.

Myocarditis Causing Premature Ventricular Contractions: Insights From the MAVERIC Registry.

BACKGROUND: Premature ventricular contractions are a common clinical presentation that drives further diagnostic workup. We hypothesize the presence of underlying inflammation is often unrecognized in these patients with a potential for continued disease progression if not diagnosed and treated early in the disease course. METHODS: This is a single-center, prospective study including 107 patients with frequent symptomatic premature ventricular contractions (>5000/24 h) and no known ischemic heart disease. Patients underwent a combination of laboratory testing, 18F-fluorodeoxyglucose positron emission tomography scan, cardiac magnetic resonance imaging, and biopsy. Patients were diagnosed with myocarditis based on a multidisciplinary approach and treated with immunosuppressive therapy. RESULTS: The mean age of the cohort was 57±15 years, 41% were males, and left ventricular ejection fraction was 47±11.8%. Positive positron emission tomography scan was seen in 51% (55/107), of which 51% (28/55) had preserved left ventricle function. Based on clinical profile, 18F-fluorodeoxyglucose-positron emission tomography imaging, cardiac magnetic resonance, and histological data 58% patients (32/55) received immunosuppressive therapy alone and 25.4% (14/55) received immunosuppressive therapy and catheter ablation. Optimal response was seen in 67% (31/46) over a mean follow-up of 6±3 months. In patients with left ventricle systolic dysfunction, 37% (10/27) showed an improvement in mean left ventricular ejection fraction of 13±6%. CONCLUSIONS: Approximately 51% of patients presenting with frequent premature ventricular contractions have underlying myocardial inflammation in this cohort. 18F-fluorodeoxyglucose-positron emission tomography scan can be a useful modality for early diagnosis and treatment with immunosuppressive therapy in selected patients can improve clinical outcomes.

Assessment of DNA Damage After Ionizing Radiation Exposure in Patients Undergoing Cardiac Resynchronization Therapy Device Implantation or Atrial Fibrillation Ablation (The RADAR Study).

BACKGROUND: There is limited data regarding effect of prolonged radiation exposure during electrophysiological (EP) procedures on direct DNA damage. Comet test has shown to assess DNA damage following radiation exposure. METHODS: We performed a single-center prospective observational study assessing direct DNA damage using the quantitative comet assay in patients undergoing cardiac resynchronization (CRT) and atrial fibrillation (AF) catheter ablation procedures. Venous comet assay was performed pre, immediately post procedure and at 3-month duration in twenty-two (N=22) patients who underwent catheter ablation for symptomatic AF and fourteen (N=14) patients who underwent CRT implantation. RESULTS: The median [interquartile range (IQR)] fluoroscopy time, radiation dose and dose area product (DAP) were 34.3 (27.97 - 45.48) minutes, 853.07 (611.36 - 1334.76) mGy and 16,994.10 (9,023.65 - 58,845.00) UGym2 in the ablation group and 30.05 (18.75 - 37.33) minutes, 345.00 (165.09 - 924.79) mGy and 11,837.20 [7182.67 - 35567.75] UGym2 in the CRT group. When compared with pre-procedure, there was a statistically significant increase in median (IQR) DNA migration on comet assay in the ablation group immediately post procedure [+6.55 µm (0.78, 10.25, p=0.02)] that subsequently decreased at 3 months [-1.00 µm (-2.20, 0.78), p=0.03] but not in the CRT group. CONCLUSION: There was a significant increase in DNA damage as detected by comet assay immediately post procedure that normalized at 3 months in patients undergoing AF ablation. Further large prospective studies are warranted to evaluate the impact of this prolonged radiation exposure and DNA damage on long-term follow up.

Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation.

BACKGROUND: Atrioventricular node (AVN) ablation and permanent pacing is an established strategy for rate control in the management of symptomatic atrial fibrillation (AF). Leadless pacemakers (LPs) can overcome some of the short-term and long-term limitations of conventional transvenous pacemakers (CTPs). OBJECTIVES: The purpose of this study was to compare the feasibility and safety of LP with those of single-chamber CTP in patients with AF undergoing AVN ablation. METHODS: We conducted a multicenter observational study of patients undergoing AVN ablation and pacemaker implantation (LP vs single-chamber CTP) between February 1, 2014 and November 15, 2016. The primary efficacy end points were acceptable sensing (R wave amplitude ≥5.0 mV) and pacing thresholds (≤2.0 V at 0.4 ms) at follow-up. Safety end points included device-related major and minor (early <1 month, late >1 month) adverse events. RESULTS: A total of 127 patients with LP (n = 60) and CTP (n = 67) were studied. The median follow-up was 12 months (interquartile range 12-18 months). Ninety-five percent of the LP group and 97% of the CTP group met the primary efficacy end point at follow-up (57 of 60 vs 65 of 67; P = .66). There was 1 major adverse event (loss of pacing and sensing) in the LP group and 2 (lead dislodgement) in the CTP group (1 of 60 vs 2 of 67; P = 1.00). There were 6 minor adverse events (5 early and 1 late) in the LP group and 3 (early) in the CTP group (6 of 60 vs 3 of 67; P = .30). CONCLUSION: Our results demonstrate the feasibility and safety of LP compared with CTP in patients undergoing AVN ablation for AF.

Mechanical function of the left atrium is improved with epicardial ligation of the left atrial appendage: Insights from the LAFIT-LARIAT Registry.

BACKGROUND: Left atrial (LA) strain (ε) and ε rate (SR) analysis by 2-dimensional speckle tracking echocardiography is a novel method for functional assessment of the LA. OBJECTIVE: The purpose of this study was to determine the impact of left atrial appendage (LAA) exclusion by Lariat epicardial ligation on mechanical function of the LA by performing ε and SR analysis before and after the procedure. METHODS: A total of 66 patients who underwent successful LAA exclusion were included in the study. Of these 66 patients, 32 had adequate paired data for ε and SR analysis. SR during ventricular systole (LA-SRs) represents LA reservoir function, and SR during early ventricular diastole (LA-SRe) represents LA conduit function. ε and SR were determined from apical 4- and 2-chamber views using the electrocardiographic QRS as a reference point. LA volume index as surrogate for LA remodeling was measured from apical views. RESULTS: Mean patient age was 70 ± 9.2 years. LAA ligation resulted in improved reservoir function (LA-SRs: pre 0.72, confidence interval [CI] 0.63-0.83 vs post 0.81, CI 0.73-0.98; P = .043) and conduit function (LA-SRe: pre 0.74, CI 0.67-0.99 vs post 0.89, CI 0.82-1.07; P = .025). LA volume index improved significantly with the Lariat (pre 35.4, CI 29.4-37.2 vs post 29.2, CI 28.2-35.9; P <.023). CONCLUSION: LAA exclusion seems to improve mechanical function of the LA and results in reverse LA remodeling.

Epicardial Left Atrial Appendage Exclusion Reduces Blood Pressure in Patients With Atrial Fibrillation and Hypertension.

BACKGROUND: Percutaneous left atrial appendage exclusion (LAAE) has evolved as an alternative strategy for stroke prevention in atrial fibrillation (AF). Recent observational data have suggested that epicardial LAAE can have substantial impact on arrhythmia burden and hemodynamic profile. OBJECTIVES: The authors aimed to study the impact of epicardial versus endocardial LAAE on systemic blood pressure in hypertensive AF patients. METHODS: This was a prospective, nonrandomized study comparing 247 patients who underwent epicardial LAAE with 124 patients with endocardial exclusion. Clinical outcomes were measured at 3 months and 1 year. Primary outcome was improvement in systolic blood pressure (SBP) between both groups compared with baseline. Secondary outcome included changes in diastolic pressures (DBP), serum electrolytes, and creatinine. RESULTS: There was no significant difference in baseline SBP between epicardial and endocardial groups. SBP was significantly lower in the epicardial group both at 3 months (122 ± 11.8 mm Hg vs. 129.7 ± 8.2 mm Hg; p < 0.001) and 1 year (123 ± 11.6 mm Hg vs. 132.2 ± 8.8 mm Hg; p < 0.001) compared with the endocardial group. An adjusted multivariate linear mixed effects model demonstrated that epicardial LAAE significantly decreased SBP by 7.4 mm Hg at 3 months and by 8.9 mm Hg at 1 year (p < 0.0001). There was a trend toward lower DBP with epicardial LAAE at 3 months by 1.3 mm Hg (p = 0.2) and at 1 year by 1.8 mm Hg (p = 0.09). There was no significant difference in serum electrolytes and creatinine between both groups. CONCLUSIONS: In hypertensive AF patients, epicardial LAAE significantly decreases SBP both at 3 and 12 months compared with endocardial exclusion.

Risk of ventricular tachyarrhythmias following improvement of left ventricular ejection fraction in patients with implantable cardiac defibrillators implanted for primary prevention of sudden cardiac death.

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.

Safety and Efficacy of Inpatient Initiation of Dofetilide versus Sotalol for atrial fibrillation.

BACKGROUND: We sought to investigate and compare the safety and efficacy of two commonly used antiarrhythmic drugs, Dofetilide (DF) and Sotalol (SL), during inpatient drug initiation in patients with symptomatic atrial fibrillation (AF). METHODS: We performed a single center retrospective study of consecutive patients, admitted for initiation of either DF or SL, for AF between 2012 and 2015. Rates of successful cardioversion, QT interval prolongation, adverse events and drug discontinuations were calculated and compared. A two-tailed p value less than 0.05 was considered statistically significant. RESULTS: Of 378 patients, 298 (78.8%) received DF and 80 (21.2%) SL, mean age was 64 ± 11 years, 90% were Caucasians and 66% were males. Among the patients who remained in AF upon admission (DF: 215/298 (72%) vs. SL: 48/80 (60%)), no significant differences were noted in pharmacological cardioversion rates (DF: 125/215(58%) vs. SL: 30/48 (62.5%); p = 0.58). Baseline QTc was similar between the groups, with higher dose dependent QTc prolongation with DF (472.25± 31.3 vs. 458± 27.03; p = 0.008). There were no significant differences in the rates of adverse events such as bradycardia (7.4% vs. 11.3%; p = 0.26), Torsades de pointes (1.3% vs. 1.2%; p = 1.00), and drug discontinuation (9.0% vs. 5.0%; p = 0.47) between the two groups.