Search

Background: Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking., Objective: We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database., Methods: A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events., Results: A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events)., Conclusion: LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications., (© 2023 Wiley Periodicals LLC.)

Competing Interests: Funding Support and Author Disclosures Dr Doshi has received a grant from Boston Scientific. Dr Dukkipati has received a grant from Biosense Webster; and holds equity in Farapulse and Manual Surgical Sciences. Dr Neuzil has received grants from Biosense Webster and Boston Scientific. Dr Reddy is a consultant to Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, APN Health, Aquaheart, Atacor, AtiAN, Autonomix, Axon Therapies, Backbeat, BioSig, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cardiac Implants, CardiaCare, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, CoreMap, CoRISMA, Corvia Medical, Dinova-Hangzhou Nuomao Medtech, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Gore & Associates, HRT, Impulse Dynamics, Intershunt, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Medtronic, Middlepeak, Neutrace, Nuvera, Philips, Pulse Biosciences, Restore Medical, Sirona Medical, and Valcare; and holds equity in Ablacon, Acutus Medical, Affera, Apama Medical, APN Health, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Cardiac Implants, CardiaCare, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou Nuomao Medtech, East End Medical), EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxCath, Manual Surgical Sciences, Medlumics, Middlepeak, Neutrace, Newpace, Nuvera, Restore Medical, Sirona Medical, Surecor, Valcare, and Vizaramed (Equity). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Thromboembolic (TE) events are among the most common and devastating adverse events in patients with continuous-flow left ventricular assist device (cf-LVAD). Given the high burden of AF among cf-LVAD patients, we sought to evaluate the effect of concomitant surgical LAAO in patients receiving cf-LVAD., Methods: A systematic search using electronic databases was performed using the keywords: "left atrial appendage occlusion" and "left ventricular assist device." Statistical analysis was performed using metapackage for R version 4.0 and Rstudio version 1.2. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data between two groups. The primary outcomes included: (a) stroke; (b) LVAD pump thrombosis; (c) all-cause mortality RESULTS: Three studies with a total of 305 patients (LAAO = 68 and No-LAAO = 237) were included in the analysis. HeartMate II (39%) and Heartware (27.5%) were the two most common cf-LVADs utilized, while only 5% received HeartMate III. At a mean follow up of 1.47 years, LAAO group had a lower risk of stroke (8.8% vs. 15.2%, RR 0.64; 95% CI 0.28-1.49), LVAD pump thrombosis (1.5% vs. 3.8%, RR 0.28; 95% CI 0.05-1.55) and all-cause mortality (5.9% vs. 20.2%, RR 0.69; 95% CI 0.19-2.52) when compared with no-LAAO group, but the difference did not reach statistical significance., Conclusion: Concomitant surgical LAAO at the time of cf-LVAD implantation demonstrated a trend toward positive outcomes and was not associated with adverse outcomes during the follow-up period, though the results were not statistically significant., (© 2022 Wiley Periodicals LLC.)

Objectives: This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by intracardiac echocardiography (ICE)., Background: Limitations of current transcatheter LAAC devices include the need for precise coaxial delivery into the left atrial appendage (LAA), potential for traumatic implantation, incomplete LAA seal, and device-related thrombus., Methods: The device (Conformal Left Atrial Appendage Seal, Conformal Medical Inc) is a self-expanding occluder consisting of a cylindrical nitinol endoskeleton with low-profile anchor barbs around the midpoint, covered with a porous foam cup. In a prospective single-center series, under conscious sedation, the device was delivered under fluoroscopic and ICE guidance. After positioning, a transesophageal echocardiography probe was placed to confirm ICE findings before device release. After closure, dual antiplatelet therapy was administered for 6 months. Follow-up imaging was planned for 45 days and 6 and 12 months., Results: A total of 15 patients (age 71.3 ± 10.8 years, 33% men, CHA 2 DS 2 -VASc 4.1 ± 1.7, HAS-BLED 3.4 ± 1.4) underwent LAAC, 100% successfully. There were no procedure/device-related complications requiring intervention. Asymptomatic pericardial effusion occurred in 2 patients. The 45-day, 6-month, and 12-month follow-up imaging in 11, 9, and 13 patients, respectively, revealed adequate LAA seal (leak ≤5 mm) in all patients; device-related thrombus was detected in 1 patient at 6 months. Over 1-year follow-up, there were no ischemic strokes and 1 minor bleed. Nonprocedure-/device-related death occurred in 2 patients., Conclusions: This first report indicates that LAAC with the conformable implant guided by ICE imaging is feasible with encouraging 1-year clinical outcomes. (The Conformal Prague Study; NCT04193826)., Competing Interests: Funding Support and Author Disclosures Conformal Medical, Inc, provided funding for this study. Dr Neuzil has received grants from Conformal Medical Inc and Biosense Webster Inc. Dr Dukkipati has received a grant from Biosense Webster. Dr Reddy has served as an unpaid consultant to Conformal Medical Inc and Biosense Webster Inc; has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Fire1, Javelin, Kardium, Keystone Heart, LuxCath, Medlumics, Middlepeak, Nuvera, Sirona Medical, and Valcare unrelated to this work; has served as a consultant for Abbott, Axon, Biotronik, Cardiofocus, Cardionomic, CardioNXT/AFTx, EBR, Impulse Dynamics, Medtronic, Philips, Pulse Biosciences, Stimda, and Thermedical unrelated to this work; and has equity in Manual Surgical Sciences, Newpace, Surecor, and Vizaramed unrelated to this work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Introduction: The LARIAT epicardial suture snaring device has been fraught with technical challenges and procedural complications. Over time, technique modification and improved operator experience have helped overcome many of these challenges. METHODS AND RESULTS: Studies reporting left atrial appendage epicardial closure over a 12-year period from 2009 to 2020 were evaluated. The primary efficacy outcome evaluated was left atrial appendage closure with residual flow ≤1 mm. Safety outcomes evaluated were periprocedural and long term complications after device placement. Nine studies consisting of 1430 patients were included in this analysis, of which 1386 (97%) underwent successful device placement. The mean age was 69.3 years, with a mean CHADS 2 -VASC score of 3.78. Primary efficacy end point was achieved in 95.8% patients immediately after device placement, and in 92.8% patients on long term follow-up. Early procedural complications consisted of pericardial effusion 5.6%, cardiac perforation 2.7%, pericarditis 2.6%, and need for open heart surgery 1.5%. Long term complications consisted of all-cause mortality 2.3%, stroke 1.5%, and left atrial appendage thrombus 2.3%. Reduced complications were noted using micropuncture needles (2.20% vs. 10.14%; p < .0001), a longer duration pericardial drainage, and use of anti-inflammatory medications (1.58% vs. 8.4%). Oral anticoagulation use decreased from 44.7% to 22.9% post device implantation, and to 8.5% on last clinical follow up., Conclusions: The LARIAT device is effective in epicardial closure of the left atrial appendage. Improvement in device techniques such as use of micropuncture needle, prophylactic colchicine, and maintenance of a pericardial drain have helped improve safety over time., (© 2021 Wiley Periodicals LLC.)

The thromboembolic complications of Atrial fibrillation (AF) remain a major problem in contemporary clinical practice. Despite advances and developments in anticoagulation strategies, therapy is complicated by the high risk of bleeding complications and need for meticulous medication compliance. Over the past few decades, the left atrial appendage has emerged as a promising therapeutic target to prevent thromboembolic events while mitigating bleeding complications and compliance issues. Emerging data indicates that it is a safe, effective and feasible alternative to systemic anticoagulation in patients with non-valvular AF. A number of devices have been developed for endocardial or epicardial based isolation of the left atrial appendage. Increasing experience has improved overall procedural safety and ease while simultaneously reducing device related complication rates. Furthermore, increasing recognition of the non-mechanical advantages of this procedure has led to further interest in its utility for further indications beyond the prevention of thromboembolic complications. In this review, we present a comprehensive overview of the evolution of left atrial appendage occlusion, commercially available devices and the role of this modality in the current management of AF. We also provide a brief outline of the landmark trials supporting this approach as well as the ongoing research and future prospects of left atrial appendage occlusion., (© 2021 Wiley Periodicals LLC.)

Background: Left atrial appendage closure (LAAC) has proven to be an effective alternative to long-term oral anticoagulation in the prevention of thromboembolic events in patients with atrial fibrillation. In a minority of patients, inadequate seal may result in persistent peridevice flow and inability of the appendage to fully thrombose, thereby representing a potential source for thromboembolism., Objective: The purpose of this study was to study the use of endovascular coiling of the appendage to address persistent peridevice leak in patients undergoing LAAC with the Watchman device., Methods: This is a retrospective single-center analysis involving patients who underwent placement of a LAAC device and returned for endovascular coiling to address persistent device leak between 2018 and 2020. Baseline characteristics, procedural outcomes, and follow-up echocardiograms were analyzed to demonstrate the feasibility and safety of this technique., Results: Patients (N = 20) were identified with a mean leak size of 3.8 ± 1.3 mm (range 2.5-7 mm), all of whom had a non-thrombosed appendage. Acute procedural success was achieved in 95% of patients. Complete or significant reduction in flow beyond the LAAC device was achieved in 61% and 33% of patients, respectively. The 1 procedure-related adverse event was a pericardial effusion before coil deployment, requiring percutaneous drainage., Conclusion: The clinical impact of residual peridevice leak post-Watchman implantation is a matter of continuing investigation. However, appendage coiling represents a new therapeutic tool to address this potential source for thromboembolism. Further studies should address the clinical impact of this technique, including the safety of discontinuing anticoagulation after successful coiling., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia., Objective: To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation., Methods: A single-center prospective registry of atrial fibrillation patients planned for LAAC with the FLX device underwent ICE-guided implantation with conscious sedation. Transesophageal echocardiography (TEE) imaging was done preprocedure (to assess LAA size and exclude thrombus) and at clinical follow-up at 6-12 weeks. Clinical outcomes were LAA closure success, complications, leak, or DRT on follow-up TEE and major safety events., Results: The study included 30 patients: age 75 ± 8 years, 53% men, CHA 2 DS 2 -VASc 4.6 ± 1.6, and HAS-BLED 3.4 ± 1.1. The primary indication was prior bleeding in 60% (72% GI bleeding). The LAA orifice width and length were 22.7 ± 3.1 and 25.7 ± 5.7 mm, respectively. Technical success was 100% (the first-choice device was used in 28 of 30). Procedure time was less than 30 min in 27 of 30 cases, with 36 ± 15 ml contrast used. The final device size was 29.2 ± 4.7 mm with 21.6 ± 4.5% compression. There were no procedure-related complications. Follow-up TEE at a median 47 days follow-up showed 100% device success with no DRT or peridevice leak ≥5 mm. Major safety events occurred in 6.6% (2/30)., Conclusion: The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE., (© 2021 Wiley Periodicals LLC.)

Purpose of Review: In patients with atrial fibrillation who are unable to take novel oral anticoagulants for stroke prophylaxis due to bleeding risk or other contraindications, left atrial appendage (LAA) occlusion and exclusion devices have shown benefit. In this review, we highlight the risks and benefits associated with LAA removal., Recent Findings: LAA, once considered a vestigial organ, has been shown to have physiological, anatomical, and arrhythmogenic properties. Device-related complications such as pericardial effusion, device embolization, device-related thrombus, while uncommon, are still present. With increased operator experience related to appendage occlusion, overall procedural complications have declined. Further refinements in device technology will help decrease complications. While benefits of appendage removal are plenty, procedural complications need to be weighed into the equation when making decisions regarding LAA occlusion.

Introduction: Novel oral anticoagulants (NOACs) are commonly used for thromboembolic risk reduction and treatment of pulmonary embolism and deep venous thrombosis. However, data regarding their efficacy and safety in comparison to warfarin for left atrial appendage thrombus is limited., Methods: A comprehensive literature search in PubMed, Google Scholar, and Cochrane Review from inception to 30 October 2019 was performed. Studies reporting clinical outcomes comparing warfarin vs NOACs were included. Two investigators independently extracted the data and individual quality assessment was performed. A meta-analysis was performed using random-effects model to calculate risk ratio (RR) and 95% confidence interval (CI). The analysis was performed using RevMan 5.3., Results: Four studies met inclusion criteria and a total of 322 patients were included of whom 141 were in the NOAC arm and 181 were in the warfarin arm. There was no significant difference in thrombus resolution between the two groups (RR, 1.00; 95% CI [0.77-1.29; P = .98]). There was no significant difference in major bleeding (RR, 1.30; 95% CI [0.14-12.21; P = .82]) or stroke (RR, 0.42; 95% CI [0.09-2.06; P = .29]) between the two groups., Conclusion: The results of our meta-analysis show that NOACs are as efficacious and safe as warfarin in the treatment of left atrial appendage thrombus in patients with non-valvular atrial fibrillation., (© 2020 Wiley Periodicals, Inc.)

Background: Electrophysiological procedures such as epicardial ventricular tachycardia ablation and Lariat left atrial appendage ligation that involve the epicardial space are typically associated with significant postoperative pain due to mechanical irritation and associated inflammation. There is an unmet need for an effective pain management strategy in this group of patients. We studied how this impacts patient comfort and duration of hospitalization and other associated comorbidities related to pericardial access., Methods: This is a multicenter retrospective study including 104 patients who underwent epicardial ventricular tachycardia ablation and Lariat left atrial appendage exclusion. We compared 53 patients who received postprocedural intrapericardial liposomal bupivacaine (LB)+oral colchicine (LB group) and 51 patients who received colchicine alone (non-LB group) between January 2015 and March 2018., Results: LB was associated with significant lowering of median pain scale at 6 hours (1.0 [0-2.0] versus 8.0 [6.0-8.0], P <0.001), 12 hours (1.0 [1.0-2.0] versus 6.0 [5.0-6.0], P <0.001), and up to 48 hours postprocedure. Incidence of acute severe pericarditis delayed pericardial effusion and gastrointestinal adverse effects were similar in both groups. Median length of stay was significantly lower in LB group (2.0 versus 3.0; adjusted linear coefficient -1 [CI -1.3 to -0.6], P <0.001). Subgroup analysis demonstrated similar favorable outcomes in both Lariat and epicardial ventricular tachycardia ablation groups., Conclusions: Addition of intrapericardial postprocedural LB to oral colchicine in patients undergoing epicardial access during ventricular tachycardia ablation or Lariat procedure is associated with significantly decreased numeric pain score up to 48 hours compared with colchicine alone. It is also associated with significantly shorter length of hospital stay without an increase in the risk of adverse events.

Objectives: This study aimed to investigate the feasibility and safety of left atrial appendage occlusion (LAAO) procedures in patients with persistent left atrial appendage (LAA) thrombus., Background: The left atrial appendage (LAA) is the most common site of thrombus formation in patients with nonvalvular atrial fibrillation (AF). Oral anticoagulation (OAC) is used to prevent and treat AF-related thrombus. However, a significant proportion of patients may not be eligible for long-term OAC therapy. In many cases, OAC may fail to resolve the thrombus. Left atrial appendage occlusion (LAAO) may be a potential option in such cases. Major LAAO studies have excluded patients with LAA thrombus, and it is not known whether LAAO procedures in the presence of LAA thrombus is feasible and safe., Methods: This was a systematic review of patient-level data of all published cases of LAAO in the presence of LAA thrombus., Results: There was a total of 58 patients included in the study. Most of the patients had a distally located thrombus in the LAA. All cases underwent successful implantation of LAAO devices with some procedural modifications. Amulet was the most commonly used device (50%). A cerebral protection device was used in 17 (29%) patients, and procedural transesophageal echocardiography was used in most of the cases. One stroke (1.7%) and 2 (3.4%) device-related thromboses were noted during the mean follow-up of 3.4 ± 7 months., Conclusions: Percutaneous LAAO procedures appear to be feasible in patients with a distally located persistent LAA thrombus when performed by experienced operators with some technical modifications. Further studies are required to determine the long-term safety and efficacy of this approach., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the safety and feasibility of percutaneous retrieval of left atrial appendage closure (LAAC) devices with an endoscopic grasping tool., Background: Transcatheter LAAC is a mechanical stroke prevention strategy in patients with nonvalvular atrial fibrillation (AF) who are poor candidates for long-term oral anticoagulation. However, these LAAC devices can be inadvertently released into an unfavorable location, the device might migrate to a different (unfavorable) position within the left atrial appendage (LAA) or may embolize from the heart into the aorta. In such instances, it can be challenging to remove the LAAC device without open cardiac or vascular surgery., Methods: This study reports on a series of 4 cases in which an endoscopic grasping tool (Raptor) designed for gastrointestinal applications was used to percutaneously (non-surgically) remove LAAC devices that were either malpositioned or embolized., Results: LAAC devices were safely and non-surgically removed using the grasping device in all 4 cases (Amulet: 1, Watchman: 3). Devices were successfully retrieved from the left inferior pulmonary vein, descending aorta, aortic arch, and the edge of the LAA ostium. Time of device retrieval post-LAAC implantation ranged from 24 h to 1 year. Special precautionary measures, such as preemptive pericardial access, embolic protection devices, and intraprocedural imaging, were used in 2 cases., Conclusions: This case series demonstrated that the endoscopic grasping tool appeared to be safe and useful to percutaneously retrieve LAAC devices., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Percutaneous left atrial appendage closure (pLAAC) emerged as an option for stroke prevention in patients with atrial fibrillation ineligible for long-term anticoagulation. Real-world data on pLAAC's in-hospital and 30-day readmission measures are limited., Objective: We sought to report the nationwide incidence of the above outcomes using 2016 claims data., Methods: We used the National Inpatient Sample for in-hospital outcomes and Nationwide Readmissions Database for readmissions. We identified hospitalizations with a primary diagnosis of atrial fibrillation and pLAAC procedure by using International Classification of Diseases, Tenth Revision codes and compared the outcomes mentioned above between the endocardial and epicardial cohorts. Statistical analyses were performed using R 3.3.2., Results: Among 5480 pLAAC procedures (endocardial: 5145; epicardial: 335), the in-hospital mortality was 0.3%. Endocardial left atrial appendage closure (LAAC) had lower complications (8.5% vs 25.4%; P < .001) and shorter length of stay median [interquartile range] 1 [1-1] day vs 2 [1-3] days; P < .001) but higher hospitalization cost (24.13 [18.45-30.17] × 1000 dollars vs 21.21 [14.03-27.86] × 1000 dollars; P = .016). The most common complications include pericardial (endocardial vs epicardial: 3% vs 10.4%; P < .001) and renal failure (1.4% vs 6.0%; P = .004). Epicardial LAAC had higher 30-day unplanned readmissions (19.5% vs 8.3%; P = .001), with the most common reason being pericarditis and/or effusion (33.9%)., Conclusion: Endocardial LAAC had lower complications and 30-day readmissions but higher hospitalization cost. Although epicardial LAAC showed higher complications, given recent improvements in its technique, and postprocedural care demonstrated a significant reduction in pericardial complications, more contemporary data comparing these outcomes are needed., (Copyright © 2019 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

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 CHADS 2 and CHA 2 DS 2 -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., (© 2019 Wiley Periodicals, Inc.)

Background: Direct current cardioversion (DCCV) is a common rhythm control strategy in patients with symptomatic atrial fibrillation or flutter. There is no long-term data regarding the safety of DCCV in patients with endocardial left atrial appendage occlusion (LAAO) devices., Objectives: The purpose of this study was to assess the feasibility and safety of DCCV in patients with an LAAO device., Methods: This multicenter retrospective study included 148 patients with an LAAO device who underwent DCCV for symptomatic atrial fibrillation or atrial flutter., Results: The average age of the included patients was 72 ± 7 years and 59% were men. All patients (100%) had a transesophageal echocardiogram prior to DCCV. Device-related thrombus was seen in 2.7%. They were all successfully treated with oral anticoagulation (OAC) and were able to undergo DCCV after 6 to 8 weeks. DCCV restored sinus rhythm in all patients. None of the patients had DCCV-related thromboembolic complications. A total of 22% of patients were newly started on OAC after DCCV. There was no difference in DCCV-related complications between patients treated with or without OAC post-DCCV. Patients receiving OAC post-DCCV were found to undergo cardioversion at an earlier time after implantation (3.6 months [interquartile range (IQR): 0.7 to 8.6 months] vs. 8.6 months [IQR: 2.5 to 13.3 months]; p = 0.003). Three transient ischemic attacks, unrelated to DCCV, were found during follow-up. During a median follow-up of 12.8 months (IQR: 11.8 to 14.2 months), no device or left atrial thrombosis, device dislodgement, or a new device leak were observed. One patient died during follow-up due to noncardiac cause., Conclusions: DCCV is feasible in high-risk AF patients with an LAAO device without the need for oral anticoagulation if pre-procedural transesophageal echocardiography shows good device position, absence of device-related thrombus, and peridevice leak of ≤5 mm. The preliminary results are encouraging, but further large studies are warranted to establish safety., (Copyright © 2019. Published by Elsevier Inc.)

Introduction: Percutaneous left atrial appendage closure (LAAC) is typically performed utilizing transesophageal echocardiography (TEE) and fluoroscopy. Intracardiac echocardiography (ICE) can be a suitable alternative to guide implantation. Given the limited data, we performed a meta-analysis of all studies that compared ICE vs TEE for percutaneous LAAC., Methods: A comprehensive literature search was performed in PubMed, Embase, Scopus, Google Scholar, and major scientific conference sessions for published abstracts and manuscripts until 1 August 2018. Studies reporting clinical outcomes comparing TEE vs ICE for endocardial LAAC in human subjects aged greater than or equal to 18 years were included. Two investigators independently extracted the data and individual quality assessment was performed. The analysis was performed using Cochrane Collaboration software, RevMan 5.3., Results: Five eligible studies consisting of 1157 patients (ICE-391 patients and TEE-766 patients) were included. Four studies were retrospective and one was prospective, nonrandomized. Two studies included Watchman, two included the Amplatzer Cardiac Plug/Amulet device, and one included both devices. There was no significant difference in CHA2DS2VASC or HAS-BLED scores between both groups. There was no significant difference in acute procedural success between ICE vs TEE (risk ratio, 1.01; 95% CI, 0.99-1.04; P = 0.24). There was no significant difference in fluoroscopy time (mean difference [MD], 1.84 minutes; 95% CI, 0.59-4.27; P = 0.14) and total procedure time (MD, -5.06 minutes; 95% CI, -24.6-14.4; P = 0.61) between both groups. There was also no significant difference in complications including pericardial tamponade, device embolization, and stroke between both groups., Conclusion: In our meta-analysis, ICE was as effective as TEE during percutaneous LAAC., (© 2018 Wiley Periodicals, Inc.)

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., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Left atrial appendage (LAA) closure has evolved as an effective strategy for stroke prevention in patients with atrial fibrillation who are considered suitable for oral anticoagulation. There is strong evidence based on randomized clinical trials with 1 percutaneous device, as well as a large registry experience with several devices, regarding the safety and efficacy of this strategy. In addition, there is encouraging data regarding the effect of epicardial LAA closure on decreasing arrhythmia burden and improvements in systemic homeostasis by neurohormonal modulation. However, there are several unresolved issues regarding optimal patient selection, device selection, management of periprocedural complications including device-related thrombus, residual leaks, and pericarditis. In this review, we summarize the rationale, evidence, optimal patient selection, and common challenges encountered with mechanical LAA exclusion., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Left atrial appendage closure (LAAC) has emerged as a viable option for stroke prevention, especially in those intolerant of or not suitable for long-term oral anticoagulation therapy. This article describes the clinical characteristics, indications, and a proposed referral system for potential LAAC patients. Patient selection remains a challenge because of the paradox between the available randomized data on this intervention and the actual patient population who may gain maximum benefit. Further investigations comparing different LAAC devices with each other and with novel oral anticoagulants are needed. Also, the optimal antithrombotic regimen post-procedure has yet to be determined., (Copyright © 2017 Elsevier Inc. All rights reserved.)

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., (© 2017 Wiley Periodicals, Inc.)

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., (© 2016 Wiley Periodicals, Inc.)