Unveiling the Hidden Stroke Threat in Patients With Atrial Fibrillation and Primary Hyperparathyroidism.

Recent American College of Cardiology (ACC), American Heart Association (AHA), American College of Clinical Pharmacy (ACCP), and Heart Rhythm Society (HRS) guidelines suggest that patients with atrial fibrillation (AF) at intermediate to low annual risk of ischemic stroke can benefit from consideration of factors that might modify their risk of stroke. The role of nontraditional risk factors, such as primary hyperparathyroidism (PHPT), remains unexplored. In our study, we investigated the potential association between PHPT and the risk of ischemic stroke in patients with AF. Using data from the Nationwide Inpatient Sample Database, a retrospective cohort study focused on the adult population with AF, we stratified the participants based on PHPT presence. Demographic information, co-morbidities, and hospitalization details were extracted using International Classification of Diseases, Tenth revision codes. Propensity score matching was applied, encompassing over 20 confounding variables, including the risk factors outlined in the CHA2DS2-VASc (Congestive heart failure (C), Hypertension (H), Age ≥75 years (A2), Diabetes Mellitus (D), Stroke/Transient Ischemic Attack (TIA)/Thromboembolism (S2), Vascular disease (V), Age 65-74 years (A), Sex category [female] (Sc)) score. Multivariate logistic regression analysis was performed after matching to assess the independent impact of PHPT as an ischemic stroke risk factor. A total of 2,051 of the identified 395,249 patients with AF had PHPT. The PHPT group had an average age of 74 years and consisted of more women (66.1% vs 53.0%). After matching, it was observed that the PHPT group had longer hospital stays (5 vs 4 days) and higher hospitalization charges ($45,126 vs $36,644). This group exhibited higher rates of ischemic stroke (6.0% vs 4.4%) and mortality (6.3% vs 4.9%). The adjusted outcomes showed a 1.4-fold increased risk for ischemic stroke and a 1.32-fold increased risk for mortality in the PHPT cohort. The subgroup analysis showed a higher incidence of mortality in men with a high CHA2DS2-VASc score. In conclusion, this study highlights a marked association between PHPT and ischemic stroke in patients with AF, independent of the conventional CHA2DS2-VASc score. The potential mechanisms implicated include vascular changes, cardiac dysfunction, and coagulation cascade alterations. The presence of PHPT should be taken into consideration when deciding the assessment of thromboembolic risk.

Impact of ultra-conservative ICD programming in patients with LVADs: Avoiding potentially unnecessary tachy-therapies.

BACKGROUND: Patients with left ventricular assist devices (LVAD) often tolerate ventricular arrhythmias (VA). We aim to assess the frequency and outcomes of ICD therapies averted by ultraconservative ICD programming (UCP) in LVAD patients. METHODS: This single center, retrospective cohort study included patients with LVADs and ICDs implanted from 2015 to 2019 that had UCP. The aim for UCP was to maximally delay VA treatments and maximize anti-tachycardia pacing (ATP) prior to ICD shocks. VA events were reviewed after UCP and evaluated under prior conservative programming to assess for potentially averted events (that would have resulted in either ATP or defibrillation with prior programming). RESULTS: Fifty patients were included in the study with follow-up of median 16 ± 10.2 months after UCP. The median time from LVAD implantation to reprogramming was 7 days (IQR 5-9 days). Fourteen patients (28%) had potentially averted VA events that would have been treated with their prior ICD programming (82 total events, median two events per patient, IQR 1-10 events). Treated VA events occurred in 15 patients (30%). Eleven of the 14 patients with potentially averted VAs had treated events as well. Only one patient reported definitive symptoms of self-limited "dizziness" during a potentially averted event that did not result in hospitalization. No patients died of complications from or needed emergent care/hospitalization due a potentially averted VA. CONCLUSIONS: UCP in LVAD patients likely prevented unnecessary VA treatments in many patients with minimal reported symptoms during these potentially averted events. Prospective studies are necessary to confirm these findings.

Economics and laboratory efficiency of atrial fibrillation ablation.

PURPOSE OF REVIEW: Atrial fibrillation is a growing public health problem and is associated with an increased risk of comorbidities with enormous socioeconomic implications. This review article focuses on fiscal burden of atrial fibrillation on the healthcare system and economic value of atrial fibrillation ablations brought to the patient and the payers by improvement in outcomes and reduction in treatment costs. RECENT FINDINGS: This article summarizes the recently published studies evaluating the economic impact of atrial fibrillation treatment. Catheter ablation have shown to be the most successful strategy for treatment of defibrillation. However, repeat ablation is associated with higher costs, over and above any subsequent procedural costs, compared with a single ablation procedure for atrial fibrillation. Cryoballoon ablation has been shown to have fewer repeat ablations than radiofrequency ablations, which resulted in overall cost reduction. Improvement in laboratory efficiency, better utilization of laboratory resources and same-day discharge strategy can lead to further healthcare savings and increase in value to all stakeholders. SUMMARY: The value of healthcare delivery for patient with atrial fibrillation can be improved by advancement in technology that demonstrates cost reduction to the health system and outcomes improvements. Implementation of tactics that decrease cost and improve outcomes can alleviate some of the financial strain on healthcare systems, which is of extreme importance in the current climate.

Electromagnetic interference from left ventricular assist devices detected in patients with implantable cardioverter-defibrillators.

INTRODUCTION: Electromagnetic interference (EMI) from left ventricular assist devices (LVADs) can cause implantable cardioverter-defibrillator (ICD) oversensing. We sought to assess the frequency of inappropriate shocks/oversensing due to LVAD-related EMI and prospectively compare integrated (IB) versus dedicated bipolar (DB) sensing in patients with LVADs. METHODS: Single-center study in LVAD patients with Medtronic or Abbott ICDs between September 2017 and March 2020. We excluded patients that were pacemaker dependent. Measurements were obtained of IB and DB sensing and noise to calculate a signal-to-noise ratio (SNR). Device checks were reviewed to assess appropriate and inappropriate sensing events. RESULTS: Forty patients (age 52 ± 14 years, 75% men, 38% ischemic cardiomyopathy) were included with the median time between LVAD implantation and enrollment of 6.7 months (2.3, 11.4 months). LVAD subtypes included: HeartWare (n = 22, 55%), Heartmate II (n = 10, 25%), and Heartmate III (n = 8, 20%). Over a follow-up duration of 21.6 ± 12.9 months after LVAD implantation, 5% of patients (n = 2) had oversensing of EMI from the LVAD (both with HeartWare LVADs and Abbott ICDs) at 4 days and 10.8 months after LVAD implantation. Both patients underwent adjustment of ventricular sensing with resolution of oversensing and no further events over 5 and 15 months of further follow-up. The SNR was similar between IB and DB sensing (50 [29-67] and 57 [41-69], p = 0.89). CONCLUSION: ICD oversensing of EMI from LVADs is infrequent and can be managed with reprogramming the sensitivity. There was no significant difference in the R-wave SNR with IB versus DB ICD leads.

Same-day discharge after cryoballoon ablation of atrial fibrillation: A multicenter experience.

BACKGROUND: It is common practice to observe patients during an overnight stay (ONS) following a catheter ablation procedure for the treatment of atrial fibrillation (AF). OBJECTIVES: To investigate the safety and economic impact of a same-day discharge (SDD) protocol after cryoballoon ablation for treatment of AF in high-volume, geographically diverse US hospitals. METHODS: We retrospectively reviewed 2374 consecutive patients (1119 SDD and 1180 ONS) who underwent cryoballoon ablation for AF at three US centers. Baseline characteristics, acute procedure-related complications, and longer-term evaluations of safety were recorded during routine clinical follow-up. The mean cost of an ONS was used in a one-way sensitivity analysis to evaluate yearly cost savings as a function of the percentage of SDD cases per year. RESULTS: The SDD and ONS cohorts were predominately male (69% vs. 67%; p = .3), but SDD patients were younger (64 ± 11 vs. 66 ± 10; p < .0001) with lower body mass index (30 ± 6 vs. 31 ± 61; p < .0001) and CHA2 DS2 -VASc scores (1.4 ± 1.0 vs. 2.2 ± 1.4; p < .0002). There was no difference between SDD and ONS in the 30-day total complication rate (n = 15 [1.26%] versus n = 24 [2.03%]; p = .136, respectively). The most common complication was hematoma in both the SDD (n = 8; 0.67%) and ONS (n = 11; 0.93%) cohorts. Sensitivity analysis demonstrated that when 50% of every 100 patients treated were discharged the same day, hospital cost savings ranged from $45 825 to $83 813 per year across US hospitals. CONCLUSIONS: SDD following cryoballoon ablation for AF appears to be safe and is associated with cost savings across different US hospitals.

Outcomes of junctional ectopic tachycardia ablation in adult population-a multicenter experience.

PURPOSE: Idiopathic junctional ectopic tachycardia (JET) is typically refractory to antiarrhythmic agents. Catheter ablation for JET is feasible but is associated with high risk of unintended atrioventricular (AV) block. There is limited data on the appropriate procedural technique and clinical outcomes with catheter ablation for idiopathic JET in adults. METHODS: This is a multicenter, retrospective study of all adult patients (age ≥ 18 years) who underwent catheter ablation for idiopathic JET. Patient, procedural characteristics, and long-term outcomes were evaluated. RESULTS: Fifteen patients [radiofrequency ablation (RF) = 14 and cryoablation = 1) were treated with catheter ablation. The median age was 58 years with 67% males. All patients underwent mapping of the right atrium and the aortic cusps prior to energy delivery. The location of earliest activation in relation to the atrioventricular (AV) node was postero-superior in 73% (11/15), posterior in 13% (2/15), and superior in 13% (2/15) respectively. Acute success was 100%. Arrhythmia recurrence occurred in 53% (8/15) all of whom underwent a repeat ablation. High-grade AV block requiring permanent pacemaker occurred in 20% (3/15). At 12-month follow-up in the redo-ablation group, 37.5% (3/8) had recurrence of the arrhythmia two of which underwent a third ablation procedure. CONCLUSION: Catheter ablation of idiopathic JET in adults is associated with a high rate of recurrence requiring multiple procedures and high risk of AV block requiring a permanent pacemaker. Mapping and ablation of the non-coronary cusp can be considered as the arrhythmia was controlled in 3 patients with no inadvertent AV block.

Exclusion of electrical and mechanical function of the left atrial appendage in patients with persistent atrial fibrillation: differences in efficacy and safety between endocardial ablation vs epicardial LARIAT ligation (the EXCLUDE LAA study).

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 CHA2DS2-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.

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.

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.

Long-term clinical outcomes from real-world experience of left atrial appendage exclusion with LARIAT device.

BACKGROUND: Left atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF). Our aim was to study long-term outcomes in patients undergoing LARIAT procedure. METHODS: We analyzed patients screened for LARIAT device in four centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other preprocedural contraindications were included in control group. We analyzed thromboembolism, bleeding events, and mortality between LAA and control group. RESULTS: About 153 patients were screened. Out of these, 108 (70.6%) patients underwent LARIAT placement (LAA arm) and 45 (29.4%) excluded patients were included in control arm. There were no differences in CHADS2 and CHA2 DS2 -VASc score. Mean HAS-BLED score was significantly higher in the LARIAT group (3.5 ± 1.06 vs 3.09 ± 1.22, P = .04). Mean follow-up time (in years) was 6.56 ± 0.84 in LAA and 6.5 ± 1.26 in control arm. During follow-up period, the LARIAT group was associated with significantly less thromboembolic events (1.9% vs 24%, P < .001), bleeding events (9.2% vs 24.4%, P = .03), and mortality (5.6% vs 20%, P = .01) as compared with the control group. CONCLUSIONS: Long-term data from routine clinical practice from our study suggests that LAA exclusion with LARIAT device is an effective treatment in management of nonvalvular AF patients with high risk of stroke, bleeding, and mortality. Further randomized trials, such as aMAZE, will provide more insight in this expanding field.

Dofetilide Initiation and Implications of Deviation From the Standard Protocol - A Real World Experience.

BACKGROUND: Manufacturer/federal drug administration (FDA) recommends inpatient initiation of dofetilide with the manufacturer providing an initiation algorithm. The outcomes of algorithm deviation have not been reported outside of clinical trials. OBJECTIVE: We sought to perform a chart review of all the patients admitted for inpatient initiation of dofetilide to report on the incidence of protocol deviations and their implications. METHODS: We performed a retrospective review of all patients over a 15-month periodwho were initiated on dofetilide for the very first time or reinitiated on dofetilide after a break of three months or more at our institution. We assessed data about patients who were given dofetilide without adherence to the protocol (i.e. protocol deviation). RESULTS: A total of 189 patients were included in the study with a median age of 66 ± 9 years. Mean baseline QTc interval was 436 ± 32 msec, and 61% (116/189) were in atrial fibrillation (AF) at the time of dofetilide initiation. In 9% (17/189) of patients, the drug was discontinued due to intolerance or inefficacy. Therapy in 49% (93/189) of patients was noted to deviate from manufacturer recommended protocol with deviations more than once in some patients during the same hospitalization. Baseline QTc exceeding 440 msec(>500msec in conduction abnormalities) was the most frequent deviation (25%; 47/189).Ventricular tachyarrhythmia occurred in 4% (7/189) of patients, did not differ between patients, and occurred with and without protocol deviations (5% vs 2%; p = 0.27). CONCLUSIONS: In our retrospective study, there were frequent deviations from the manufacturer-recommended algorithm guidelines for dofetilideinitation, primarily due to prolonged baseline QTc interval. The impact of these protocol deviations on drug discontinuation was uncertain; however, significant adverse events were higher in the deviation group compared to the group that fully adhered to the protocol. Further multicenter studies are warranted to clarify our findings.

Temporal relationships between esophageal injury type and progression in patients undergoing atrial fibrillation catheter ablation.

BACKGROUND: Currently, little is known about the onset, natural progression, and management of esophageal injuries after atrial fibrillation (AF) ablation. OBJECTIVES: We sought to provide a systematic review on esophageal injury after AF ablation and identify temporal relationships between various types of esophageal lesions, their progression, and clinical outcomes. METHODS: A comprehensive search of PubMed and Web of Science was conducted until September 21, 2017. All AF ablation patients who underwent upper gastrointestinal endoscopy within 1 week of the procedure were included. Patients with esophageal lesions were classified into 3 types by using our novel Kansas City classification: type 1: erythema; type 2a: superficial ulcers; type 2b: deep ulcers; type 3a: perforation without communication with the atria; and type 3b: perforation with atrioesophageal fistula. RESULTS: Thirty studies met our inclusion criteria. Of the 4473 patients, 3921 underwent upper gastrointestinal evaluation. The overall incidence of esophageal injuries was 15% (570). There were 206 type 1 lesions (36%), 222 type 2a lesions (39%), and 142 type 2b lesions (25%). Six of 142 type 2b lesions (4.2%) progressed further to type 3, of which, 5 were type 3a and 1 was type 3b. All type 1 and type 2a and most type 2b lesions resolved with conservative management. One type 3a and 1 type 3b lesions were fatal. CONCLUSION: Based on our classification, all type 1 and most type 2 lesions resolved with conservative management. A small percentage (4.2% [6 of 142]) of type 2b lesions progressed to perforation and/or fistula formation, and these patients need to be followed closely.

Safety and outcomes of catheter ablation for atrial fibrillation in adults with congenital heart disease: A multicenter registry study.

BACKGROUND: An increasing number of adults with congenital heart disease (CHD) are undergoing catheter ablation for atrial fibrillation (AF). Data on ablation strategy and outcomes in CHD are limited. Rhythm control is often believed to be of greater importance among patients with complex CHD. OBJECTIVE: The purpose of this study was to examine the safety and efficacy of AF ablation in adult patients with CHD. METHODS: A multicenter retrospective analysis was performed of CHD patients undergoing AF ablation. Clinical data were collected, including AF and CHD type, procedural data, and outcomes. Patients were divided into 3 groups (simple, moderate, and severe) based on CHD complexity, as defined by the 2014 PACES/HRS (Pediatric and Congenital Electrophysiology Society/Heart Rhythm Society) consensus statement. One-year procedural success was defined as freedom from recurrent AF, off antiarrhythmic drugs (complete) or off/on previously failed antiarrhythmic drugs (partial). RESULTS: Overall, 84 CHD patients (mean age 51.5 ± 12.1 years; 65.5% male; 45.2% with paroxysmal AF) undergoing AF ablation (51 simple, 22 moderate, 11 severe complexity) were included. Pulmonary vein isolation was performed in 80 (95.2%), of whom 30 (35.7%) underwent pulmonary vein isolation alone. Overall, complete and complete/partial freedom was achieved at 1 year in 53.1% and 71.6%, respectively, with no significant differences between those with simple, moderate, or severe complexity. There were no major complications and 7 minor complications, and 2 patients died during follow-up. CONCLUSION: There are dramatic differences in the degree of CHD complexity among patients referred for AF ablation. When performed at experienced centers, AF ablation is safe and effective even among patients with the most complex forms of CHD.

Early feasibility of hypoglossal nerve upper airway stimulator in patients with cardiac implantable electronic devices and continuous positive airway pressure-intolerant severe obstructive sleep apnea.

BACKGROUND: Implantable hypoglossal nerve upper airway stimulation (HNS) is a novel strategy approved by the US Food and Drug Administration for the management of moderate-to-severe obstructive sleep apnea (OSA) in patients with continuous positive airway pressure therapy intolerance or failure. Because of the proximity of a cardiac implantable electronic device (CIED) to this stimulator, interaction between these devices is theoretically possible. OBJECTIVE: The purpose of this study was to assess interactions between an implantable HNS device and a CIED. METHODS: We retrospectively analyzed 14 ad hoc patients with continuous positive airway pressure-intolerant, moderate-to-severe OSA and pre-existing transvenous CIEDs undergoing HNS implantation (Inspire II, Inspire Medical Systems). We assessed these devices for their pre and postimplant OSA outcomes and for possible device-device interaction. All patients were followed up for 1 year. RESULTS: Of the 14 patients, 9 had a pacemaker (8 dual-chamber, 1 single-chamber), 4 had an implantable cardioverter-defibrillator (2 dual-chamber, 1 single-chamber), and 1 had a cardiac resynchronization therapy device. All the HNS devices were implanted on the opposite side of the CIED. All CIEDs were programmed bipolar. HNS were programmed either unipolar or bipolar. During implant, intraoperative testing was performed to confirm that bipolar and unipolar HNS stimulation did not impact CIED sensing. During the follow-up period, no oversensing episodes were noted on the CIEDs. CONCLUSION: In this early experience, simultaneous use of a novel hypoglossal nerve upper airway stimulation device with transvenous CIEDs seems to be safe, effective, and without any device-device interactions.

Feasibility, safety, and efficacy of a novel preshaped nitinol esophageal deviator to successfully deflect the esophagus and ablate left atrium without esophageal temperature rise during atrial fibrillation ablation: The DEFLECT GUT study.

BACKGROUND: Esophageal thermal injury is a feared complication of radiofrequency ablation for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver radiofrequency energy on the posterior wall of the left atrium. OBJECTIVE: The purpose of this study was to evaluate the feasibility, safety, and efficacy of a mechanical esophageal deviation (ED) tool during AF ablation. METHODS: We evaluated 687 patients who underwent radiofrequency ablation for AF. In 209 patients, the EsoSure (Northeast Scientific) was used to deflect the esophagus away from the ablation site. Propensity score matching was performed to obtain 180 patients each in the ED and non-ED arms. ED was used for LET rise seen in 61.7% of patients (111/180) and was used if the esophagus was in the line of ablation on fluoroscopy in 38.3% of patients (69/180). RESULTS: Mean deviation of trailing edge of esophagus with EsoSure was 2.45 ± 0.9 cm (range 1-4.5). LET rise >1°C was significantly lower in the ED than non-ED group (3% vs 79.4%; P <.001). Mean LET rise was also lower in the ED arm (ED 0.34 ± 0.59 vs non-ED 1.66 ± 0.54; P <.001). Intraprocedural success of pulmonary vein antral isolation, was slightly improved in the ED arm than in the non-ED arm without statistical significance. AF recurrence was lower in the ED arm at 3-month, 6-month, and 1-year follow-up than in the non-ED arm. No ED-related complications were noted. CONCLUSION: Mechanical displacement of the esophagus with EsoSure seems to be feasible, safe, and efficacious in enabling adequate radiofrequency energy delivery to the posterior wall of the left atrium without significant LET rise and obvious clinical signs of esophageal injury.

Perioperative hematoma with subcutaneous ICD implantation: Impact of anticoagulation and antiplatelet therapies.

BACKGROUND: The safety of perioperative anticoagulation (AC) and antiplatelet (AP) therapy with subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is unknown. The purpose of this study was to identify the risk factors associated with hematoma complicating S-ICD implantation. METHODS: Records were retrospectively reviewed from 200 consecutive patients undergoing S-ICD implantation at two academic medical centers. A hematoma was defined as a device site blood accumulation requiring surgical evacuation, extended hospital stay, or transfusion. RESULTS: Among 200 patients undergoing S-ICD implantation (age 49 ± 17 years, 67% men), 10 patients (5%) had a hematoma, which required evacuation in six patients (3%). Warfarin was bridged or uninterrupted in 12 and 13 patients, respectively (6% and 6.5%). Four of 12 patients with warfarin and bridging AC (33%) and two of 13 patients with uninterrupted warfarin (15%) developed a hematoma. Neither of the two patients with uninterrupted DOAC had a hematoma. No patients on interrupted AC without bridging (n = 26, 13 with warfarin, 13 with DOAC) developed a hematoma. A hematoma was also more likely with the use of clopidogrel (n = 4/10 vs 10/190, 40% vs 5.3%, P < 0.0001) in combination with aspirin in 12/14 patients. Any bridging AC (odds ratio [OR] 10.3, 1.8-60.8, P = 0.01), clopidogrel (OR 10.0, 1.7-57.7, P = 0.01), and uninterrupted warfarin without bridging (OR 11.1, 1.7-74.3, P = 0.013) were independently associated with hematoma formation. CONCLUSION: AC and/or AP therapy with clopidogrel appears to increase the risk for hematoma following S-ICD implantation. Interruption of AC without bridging should be considered when it is an acceptable risk to hold AC.

Management of cardiac implantable electronic devices in the presence of left ventricular assist devices.

Left ventricular assist devices (LVAD) are increasingly used in the management of patients with advanced heart failure. Many of these patients have or will be considered for a cardiac implantable electronic device (CIED) such as an implantable cardioverter-defibrillator or a cardiac resynchronization therapy device. Frequent interplay is often encountered due to the complexity of these devices and the underlying disease states. Proactive management strategies and an awareness of interactions may help reduce adverse events. Here we review the current literature, present management recommendations, and discuss potential future investigations for CIEDs in patients with LVADs.

Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. RESULTS: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. CONCLUSIONS: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.