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Background: Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device., Methods: We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events)., Results: Among 87 480 patients (76.2±8.0 years; 58.8% men; mean CHA 2 DS 2 -VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57-0.77]) and Q2 (OR, 0.78 [CI, 0.69-0.90]) but not Q3 (OR, 0.95 [CI, 0.84-1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63-0.82]), Q2 (OR, 0.79 [CI, 0.71-0.89]), and Q3 (OR, 0.88 [CI, 0.79-0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles., Conclusions: In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices., Competing Interests: Disclosures Dr Friedman has received research grants from Abbott, American Heart Association, Biosense Webster, Boston Scientific, Medtronic, Merit Medical, National Cardiovascular Data Registry, and the National Institutes of Health (NIH) and consulting fees from Abbott, AtriCure, NI Medical, Microport, and Sanofi. Dr Freeman reported receiving consulting fees from Medtronic, Boston Scientific, Pacemate, and Biosense Webster; equity from Pacemate; and funding from the NIH. JPC reported an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the National Cardiovascular Data Registry (NCDR) and equity interest in Medtronic. Dr Curtis is supported by R01AG074185 from the National Institutes of Aging. He also receives grants for clinical research from Abbott, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, iRhythm, and Philips and serves as a consultant to Abbott, Abbvie, ARCA Biopharma, Bayer, Boston Scientific, Bristol Myers Squibb (Myokardia), Element Science, Itamar Medical, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, ReCor, Sanofi, Philips, and UpToDate. Dr Masoudi reported an institutional contract with the American College of Cardiology for his role as Chief Scientific Advisor of the NCDR. Dr Vemulapalli has received grants from the American College of Cardiology, Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, Boston Scientific, NIH (R01 and SBIR [Small Business Innovation Research]) and Food and Drug Administration (NEST cc [National Evaluation System for Health Technology Coordinating Center]) and serves as a consultant for Medtronic, Edwards Lifesciences, Total CME, and American College of Physicians. The other authors report no conflicts.

Background: The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX., Methods: Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model., Results: Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%-2.84%; interquartile range, 1.42%-1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65-0.70] and validation C-index, 0.66 [95% CI, 0.62-0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively., Conclusions: A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making., Competing Interests: Disclosures Dr Faridi receives research funding from the National Institutes of Health (NIH)/National Heart, Lung and Blood Institute (NHLBI;K23HL161424). Dr Friedman reports receiving research grants from Abbott, American Heart Association, Biosense Webster, Boston Scientific, Medtronic, Merit Medical, National Cardiovascular Data Registry, Phillips, and NIH, and consulting fees from Abbott, NI Medical, Microport, and Sanofi. Dr Hsu reports receiving honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Janssen Pharmaceuticals, Bristol-Myers Squibb, Pfizer, Sanofi, Altathera, Zoll Medical, Hillrom, iRhythm, Acutus Medical, Galvanize Therapeutics, and Biosense-Webster, research grants from Biotronik and Biosense-Webster, and has equity interest in Vektor Medical. Dr Mortazavi receives research funding from the National Science Foundation (IIS #2014475) and the NIH (R21EB028486, R01HL151240, R01EB028106, and R01HL142765). Dr Lakkireddy reports being a consultant for Abbott, Boston Sci, Atricure, Biosense Webster, and Acutus. Dr Curtis has a contract with the American College of Cardiology (ACC) for his role as Chief Scientific Advisor of the ACC’s National Cardiovascular Data Registry. He holds equity interest in Medtronic. Dr Freeman reports receiving research grants from the N NHLBI and the ACC National Cardiovascular Data Registry and consulting/advisory board fees from Boston Scientific, Biosense Webster, Medtronic, and PaceMate. and equity in PaceMate.

Introduction: Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization (DME) requiring percutaneous or surgical retrieval., Methods: We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and postdischarge events were assessed among patients with 45-day follow-up., Results: Of 120 278 Watchman procedures, the in-hospital DME rate was 0.07% (n = 84) and surgery was commonly performed (n = 39). In-hospital mortality rate was 14% among patients with DME and 20.5% among patients who underwent surgery. In-hospital DME was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p < .0001), with Watchman 2.5 versus Watchman FLX devices (0.08% vs. 0.04%, p = .0048), with larger LAA ostia (median 23 vs. 21 mm, p = .004), and with a smaller difference between device and LAA ostial size (median difference 4 vs. 5 mm, p = .04). Of 98 147 patients with 45-day follow-up, postdischarge DME occurred in 0.06% (n = 54) patients and cardiac surgery was performed in 7.4% (n = 4) of cases. The 45-day mortality rate was 3.7% (n = 2) among patients with postdischarge DME. Postdischarge DME was more common among men (79.7% of events but 58.9% of all procedures, p = .0019), taller patients (177.9 vs. 172 cm, p = .0005), and those with greater body mass (99.9 vs. 85.5 kg, p = .0055). The rhythm at implant was less frequently AF among patients with DME compared to those without (38.9% vs. 46.9%, p = .0098)., Conclusion: While Watchman DME is rare, it is associated with high mortality and frequently requires surgical retrieval, and a substantial proportion of events occur after discharge. Due to the severity of DME events, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance., (© 2023 Wiley Periodicals LLC.)

Objective: Older, relatively small studies identified female sex as a risk factor for adverse events after catheter ablation for atrial fibrillation (AF). We aimed to assess contemporary sex-based differences in baseline and procedural characteristics, adverse events, and quality of life among adults undergoing catheter ablation for AF., Methods: In this observational cohort study, we evaluated those enrolled in the National Cardiovascular Data Registry AFib Ablation Registry between January 2016 and September 2020. Using logistic regression, we analysed the association between patient sex and in-hospital adverse events., Results: Among 58 960 adults (34.6% women) from 150 centres undergoing AF ablation by 706 physicians, women were older (68 vs 64 years, p<0.001), had more comorbidities, and had lower AF-related quality of life at the time of ablation (mean Atrial Fibrillation Effect on QualiTy-of-life Questionnaire) score: 51.8 vs 62.2, p<0.001). Women had a higher risk of hospitalisation >1 day (adjusted OR (aOR) 1.41 (95% CI 1.33 to 1.49)), major adverse event (aOR 1.60 (95% CI 1.33 to 1.92)) and any adverse event (aOR 1.57 (95% CI 1.41 to 1.75)). Women had a higher risk of bradycardia requiring pacemaker, phrenic nerve damage, pericardial effusion, bleeding and vascular injury, but had no differences in death or acute pulmonary vein isolation., Conclusions: Among almost 60 000 patients in the largest prospective registry of AF ablation procedures, female sex was independently associated with a higher risk of hospitalisation >1 day, adverse events, and reduced quality of life, although there were no differences in death or acute pulmonary vein isolation., Competing Interests: Competing interests: DJF has received educational grants from Boston Scientific, Medtronic and Abbott; research grants from the National Cardiovascular Data Registry, Boston Scientific, Abbott, Medtronic and Biosense Webster; consulting fees from Abbott and AtriCure. EPZ reported consulting for Biosense Webster. JPC reported an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the NCDR. JVF reported salary support from the ACC NCDR and the NHLBI and consulting/advisory board fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Biosense Webster and Pacemate and equity from Pacemate., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Left atrial appendage occlusion is an important alternative to anticoagulation in select patients with nonvalvular atrial fibrillation. Trends in real-world device sizing and associated short-term complications have not been characterized., Methods: Using the National Cardiovascular Data Left Atrial Appendage Occlusion (NCDR LAAO) Registry, patients who underwent left atrial appendage occlusion with a Watchman 2.5 device from January 1, 2016, to June 30, 2020, were identified. Patients were stratified by device size based on left atrial appendage orifice size, and categorized as receiving a device that was undersized, oversized, or per manufacturer recommendation. Relationships between device sizing and short-term outcomes, including pericardial effusion, device embolism, and significant leak, were assessed., Results: Of the 68 456 patients, 6539 (10.5%) of patients received undersized devices, 17 791 (26.0%) according to manufacturer recommendations, and 44 126 (64.4%) received an oversized device. The 27-mm device was most commonly deployed [21 736 (31.8%)], whereas the smallest and largest devices (21 and 33 mm) were least commonly deployed [7695 (11.2%) and 9077 (13.3%), respectively]. Compared with manufacturer recommended sizing, there was no difference in the odds of pericardial effusion for either undersized (1.048 [95% CI' 0.801-1.372]; P= 0.733) or oversized (1.101 [95% CI' 0.933-1.298]; P= 0.254) devices. Similarly, relative to manufacturer recommended sizing, the odds of a composite adverse outcome of device migration or embolization and significant peridevice leak at 45 days were similar among undersized devices (1.030 [95% CI' 0.735-1.444]; P= 0.863) and favorable for oversized devices (0.701 [95% CI' 0.561-0.876]; P= 0.002) devices, primarily driven by lower odds of leak. Selection of oversized devices increased significantly over the study period (from 60.3% in 2016 to 66.0% in 2020; P <0.001)., Conclusions: Among patients undergoing left atrial appendage occlusion with the first-generation Watchman device, receipt of oversized devices was common and increased over time. The high prevalence of oversizing was associated with lower odds of significant leak or device embolization without increased odds of other adverse events.

Background: Clinical events committee (CEC) evaluation is the standard approach for end point adjudication in clinical trials. Due to resource constraints, large registries typically rely on site-reported end points without further confirmation, which may preclude use for regulatory oversight., Methods: We developed a novel automated adjudication algorithm (AAA) for end point adjudication in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry using an iterative process using CEC adjudication as the "gold standard." A ≥80% agreement rate between automated algorithm adjudication and CEC adjudication was prespecified as clinically acceptable. Agreement rates were calculated., Results: A total of 92 in-hospital and 127 post-discharge end points were evaluated between January 1, 2016 and June 30, 2019 using AAA and CEC. Agreement for neurologic events was >90%. Percent agreement for in-hospital and post-discharge events was as follows: ischemic stroke 95.7% and 94.5%, hemorrhagic stroke 97.8% and 96.1%, undetermined stroke 97.8% and 99.2%, transient ischemic attack 98.9% and 98.4% and intracranial hemorrhage 100.0% and 94.5%. Agreement was >80% for major bleeding (83.7% and 90.6%) and major vascular complication (89.1% and 97.6%). With this approach, <1% of site reported end points require CEC adjudication. Agreement remained very good during the period after algorithm derivation., Conclusions: An AAA-guided approach for end point adjudication was successfully developed and validated for the LAAO Registry. With this approach, the need for formal CEC adjudication was substantially reduced, with accuracy maintained above an 80% agreement threshold. After application specific validation, these methods could be applied to large registries and clinical trials to reduce the cost of event adjudication while preserving scientific validity., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described., Objectives: The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device., Methods: The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX., Results: The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001)., Conclusions: Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation., Competing Interests: Funding Support and Author Disclosures The Human Investigation Committee of the Yale University School of Medicine approved the use of a limited dataset from the NCDR for research and granted a waiver of the requirement to obtain informed consent. Boston Scientific provided partial support for this study through an investigator-initiated grant; had no role in study design, data analysis, or writing of the manuscript; and were not provided a copy of the manuscript prior to submission. This study was funded by the American College of Cardiology NCDR; National Heart, Lung, and Blood Institute grants R56HL142765 and R01HL142765; and an investigator-initiated grant from Boston Scientific. Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; has received consulting honoraria from W. L. Gore, Baylis Medical, Biotronik, Philips, Biosense Webster, and Shockwave; has received consulting honoraria and speaker fees from Medtronic; has received speaker fees from ACIST Medical; and has equity interest in Indian Wells. Dr Friedman has received research grants from the American Heart Association, the NCDR, Boston Scientific, Abbott, Medtronic, Merit Medical, and Biosense Webster; and has received consulting fees from Abbott, AtriCure, and Sanofi. Dr Curtis has an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR; and has equity in Medtronic. Dr Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; has received consulting and advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Biosense Webster, and PaceMate; and has equity interest in PaceMate. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Atrial cardiomyopathy has been recognized as having important consequences for cardiac performance and clinical outcomes. The pathophysiological role of the left atrial (LA) appendage and the effect of percutaneous left atrial appendage occlusion (LAAO) upon LA mechanics is incompletely understood. We evaluated if changes in LA stiffness due to endocardial LAAO can be detected by LA pressure-volume (PV) analysis and whether stiffness parameters are associated with baseline characteristics. Patients undergoing percutaneous endocardial LAAO ( n = 25) were studied using a novel PV analysis using near-simultaneous three-dimensional LA volume measurements by transesophageal echocardiography (TEE) and direct invasive LA pressure measurements. LA stiffness (dP/dV, change in pressure with change in volume) was calculated before and after LAAO. Overall LA stiffness significantly increased after LAAO compared with baseline (median, 0.41-0.64 mmHg/mL; P ≪ 0.001). LA body stiffness after LAAO correlated with baseline LA appendage size by indexed maximum depth (Spearman's rank correlation coefficient R s = 0.61; P < 0.01). LA stiffness change showed an even stronger correlation with baseline LA appendage size by indexed maximum depth ( R s = 0.70; P < 0.001). We found that overall LA stiffness increases after endocardial LAAO. Baseline LA appendage size correlates with the magnitude of increase and LA body stiffness. These findings document alteration of LA mechanics after endocardial LAAO and suggest that the LA appendage modulates overall LA compliance. NEW & NOTEWORTHY Our study documents a correlation of LA appendage remodeling with the degree of chronically abnormal LA body stiffness. In addition, we found that LA appendage size was the baseline parameter that best correlated with the magnitude of a further increase in overall LA stiffness after appendage occlusion. These findings offer insights about the LA appendage and LA mechanics that are relevant to patients at risk for adverse atrial remodeling, especially candidates for LA appendage occlusion.

Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States., Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events., Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA 2 DS 2 -VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P =0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication., Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.

Background: Data on the impact of residual peri-device leak after left atrial appendage occlusion (LAAO) are limited., Objectives: The goal of this study was to explore the association of peri-device leak with adverse clinical events., Methods: The National Cardiovascular Data Registry LAAO Registry was queried to identify patients undergoing LAAO between January 1, 2016, and December 31, 2019. Patients were classified according to leak size on echocardiography at 45 ± 14 days (0 mm, no leak; >0-5 mm, small leak; and >5 mm, large leak)., Results: A total of 51,333 patients were included, of whom 37,696 (73.4%) had no leak, 13,258 (25.8%) had small leaks, and 379 (0.7%) had large leaks. The proportion of patients on warfarin at 45 days was higher in the large vs small or no leak cohorts (44.9% vs 34.4% and 32.4%, respectively; P < 0.001). At 6 and 12 months, anticoagulant utilization decreased but remained more frequent in patients with large leaks. Thromboembolic and bleeding events were uncommon in all groups. However, compared with patients with no leak, those with small leaks had slightly higher odds of stroke/transient ischemic attack/systemic embolization (adjusted HR: 1.152; 95% CI: 1.025-1.294), major bleeding (HR: 1.11; 95% CI: 1.029-1.120), and any major adverse events (HR: 1.102; 95% CI: 1.048-1.160). There were no significant differences in adverse events between patients with large leaks and patients with small or no leaks., Conclusions: Small (>0-5 mm) leaks after LAAO were associated with a modestly higher incidence of thromboembolic and bleeding events; large leaks (>5 mm) were not associated with adverse events, although higher proportions of these patients were maintained on anticoagulation. Newer devices with improved seal might mitigate the events associated with residual leaks., Competing Interests: Funding Support and Author Disclosures The study was funded by a grant from Boston Scientific; the sponsor had no role in the design of the study or the interpretation of the data. Dr Alkhouli is on the advisory board of Boston Scientific. Dr Freeman has received grants from the National Heart, Lung, and Blood Institute and the American College of Cardiology NCDR during the conduct of the study; and has received personal fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols., Objectives: This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies., Methods: We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression., Results: Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up., Conclusions: In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes., Competing Interests: Funding Support and Author Disclosures This study was funded by the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) and the National Heart, Lung, and Blood Institute (NHLBI) grants R56HL142765 and R01HL142765. Dr Freeman has received salary support from the ACC NCDR and the NHLBI; and has received consulting/advisory board fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster. Dr Friedman has received educational grants from Boston Scientific, Medtronic, and Abbott; has received research grants from the NCDR, Boston Scientific, Abbott, Medtronic, and Biosense Webster; and has received consulting fees from Abbott and AtriCure. Dr Gibson has served as a consultant for Boston Scientific, Abbott, and Biosense Webster. Dr Goldsweig has received grant support from the National Institute of General Medical Sciences (1U54GM115458) and the Center for Heart and Vascular Research, University of Nebraska Medical Center. Dr Price has received consulting/advisory board fees from Boston Scientific, Medtronic, Abbott Vascular, W.L. Gore Medical, and Conformal Medical; has received speaker’s fees from Chiesi USA; and has received research grants (to institution) from Daiichi-Sankyo. Dr Reddy is an unpaid consultant to and has received grant support from Boston Scientific; has served as a consultant for Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon Therapeutics, Backbeat, BioSig, Biosense-Webster, Biotronik, Cardiac Implants, CardiaCare, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Impulse Dynamics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Pulse Biosciences, Sirona Medical, Thermedical, and Valcare; and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon Therapeutics, Backbeat, BioSig, Cardiac Implants, CardiaCare, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Manual Surgical Sciences, Middlepeak, Newpace, Nuvera, Sirona Medical, Surecor, Valcare, and Vizaramed. Dr Masoudi has received an institutional contract with the ACC for his role as Chief Scientific Advisor of the NCDR. Dr Curtis has received an institutional contract with the ACC for his role as Senior Scientific Advisor of the NCDR. Dr Doshi has received research grants (to institution) and consulting/advisory board fees from Boston Scientific, Biosense Webster, Conformal Medical, Terumo, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data., Background: Patients undergoing LAAO in clinical practice generally have more comorbidities than trial participants., Methods: Propensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models., Results: A total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P < 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P < 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients., Conclusion: In clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441)., Competing Interests: Funding Support and Author Disclosures This study was funded by the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) and the National Heart, Lung, and Blood Institute (NHLBI) grants R56HL142765 and R01HL142765. The sponsors/funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Sponsors/funders also had no right to veto publication nor to control the decision regarding to which journal the article was submitted. Boston Scientific supported the study by sharing trial data but did not have any additional role in in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Sponsors/funders also had no right to veto publication nor to control the decision regarding to which journal the article was submitted. This research was supported by the American College of Cardiology Foundation’s NCDR. The views expressed in this presentation represent those of the author(s) and do not necessarily represent the official views of the NCDR or its associated professional societies. Dr Friedman has received research support from Boston Scientific, Biosense Webster, Merit Medical, and Abbott; and has received consulting fees from Abbott and AtriCure. Dr Masoudi has an institutional contract with the American College of Cardiology for his role as Chief Scientific Advisor of the NCDR. Dr Reddy serves as a consultant to Boston Scientific; in addition, he reports the following disclosures unrelated to this manuscript: Abbott (consultant), Ablacon (consultant, equity), Acutus Medical (consultant, equity), Affera (consultant, equity), Apama Medical (consultant, equity), APN Health (consultant, equity), Aquaheart (consultant, equity), Atacor (consultant, equity), Autonomix (consultant, equity), Axon Therapies (consultant, equity), Backbeat (consultant, equity), Biosense Webster (consultant), BioSig (consultant, equity), BioTel Heart (consultant), Biotronik (consultant), Cardiac Implants (consultant, equity), CardiaCare (consultant, equity), Cardiofocus (consultant), Cardionomic (consultant), CardioNXT/AFTx (consultant, equity), Circa Scientific (consultant, equity), Corvia Medical (consultant, equity), Dinova-Hangzhou Nuomao Medtech (consultant, equity), East End Medical (consultant, equity), EBR (consultant), EPD (consultant, equity), Epix Therapeutics (consultant, equity), EpiEP (consultant, equity), Eximo (consultant, equity), Farapulse (consultant, equity), Fire1 (consultant), Gore & Associates (consultant), HRT (consultant, equity), Impulse Dynamics (consultant), Intershunt (consultant, equity), Javelin (consultant, equity), Kardium (consultant, equity), Keystone Heart (consultant, equity), LuxMed (consultant, equity), Manual Surgical Sciences (equity), Medlumics (consultant, equity), Medtronic (consultant), Middlepeak (consultant, equity), Newpace (equity), Nuvera (consultant, equity), Philips (consultant), Pulse Biosciences (consultant), Sirona Medical (consultant, equity), Surecor (equity), Valcare (consultant, equity), and Vizaramed (equity). Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; consulting honoraria and speaker fees from AstraZeneca; consulting honoraria from W.L. Gore, Baylis Medical, and Acutus; consulting honoraria and speaker fees from Medtronic; consulting fees from Biosense Webster and Shockwave; and has equity interest in Indian Wells, Inc. Dr Curtis has an institutional contract with the American College of Cardiology for his role as senior scientific advisor of the NCDR; and has equity interest in Medtronic. Dr Freeman has received consulting fees from Medtronic, Boston Scientific, Pacemate, and Biosense Webster; and has received equity from Pacemate. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pericardial effusion (PE) is a potential complication of transcatheter left atrial appendage occlusion. The objective of this study was to investigate the incidence, associated characteristics, and outcomes of PE following left atrial appendage occlusion., Methods: Patients in the NCDR LAAO Registry who underwent a Watchman procedure between January 1, 2016 and December 31, 2019 were included. The primary outcome was in-hospital PE requiring intervention (percutaneous drainage or surgery). Odds ratios (ORs) were calculated for adverse event rates associated with PE., Results: The study population consisted of 65 355 patients. The mean patient age was 76.2±8.1 years, and the mean CHA 2 DS 2 -VASc score was 4.6±1.5. PE occurred in 881 patients (1.35%). Clinical variables independently associated with PE included older age, female sex, left ventricular function, paroxysmal atrial fibrillation, prior bleeding, lower serum albumin, and preprocedural dual antiplatelet therapy; procedural variables included number of delivery sheaths used, sinus rhythm during the procedure, and moderate sedation rather than general anesthesia. PE was associated with increased risk of in-hospital stroke (OR, 6.58 [95% CI, 3.32-13.06]; P <0.0001), death (OR, 56.88 [95% CI, 39.79-81.32]; P <0.0001), and the composite of death, stroke, or systemic embolism (OR, 28.64 [95% CI, 21.24-38.61]; P <0.0001). PE during the index hospitalization was associated with increased risk of death (OR, 3.52 [95% CI, 2.23-5.54]; P <0.0001) and the composite of death, stroke, or systemic embolism (OR, 3.42 [95% CI, 2.31-5.07]; P <0.0001) between discharge and 45-day follow-up., Conclusions: In-hospital PE during transcatheter left atrial appendage occlusion is infrequent but associated with a substantially higher risk of adverse events, including in-hospital and early postdischarge mortality. Strategies to minimize PE are critical to improve the risk-benefit ratio for this therapy.

Objectives: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States., Background: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported., Methods: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates., Results: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA 2 DS 2 -VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure., Conclusions: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy., Competing Interests: Funding Support and Author Disclosures This study was funded by the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute (grants R56HL142765 and R01HL142765). Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Boston Scientific; has received consulting honoraria from W.L. Gore, Baylis Medical, Philips, Biotronik, Biosense Webster, and Shockwave; has received consulting honoraria and speaker fees from Medtronic; and has equity interest in Indian Wells. Dr Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; and has received consulting and advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster. Dr Rammohan has received consulting fees from Medtronic and Abbott Vascular. Dr Turi has received honoraria from Coherex for serving on the clinical events committee for the WAVECREST 2 (Wavecrest vs. Watchman Transseptal LAA Closure to Reduce AF-Mediated Stroke 2) trial. Dr Varosy has received salary support from the National Heart, Lung, and Blood Institute. Dr Curtis has an institutional contract with the American College of Cardiology for his role as senior scientific adviser of the NCDR; has received salary support from the American College of Cardiology and CMS; and has equity in Medtronic. Dr Masoudi has had an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR. 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.)

Background: Implantable cardioverter-defibrillators (ICDs) are recommended for patients with cardiac sarcoidosis (CS) with an indication for pacing, prior ventricular arrhythmias, cardiac arrest, or left ventricular ejection fraction <35%, but data on outcomes are limited., Methods: Using data from the National Cardiovascular Data Registry ICD Registry between April 1, 2010 and December 31, 2015, we evaluated a propensity matched cohort of CS patients implanted with ICDs versus non-ischemic cardiomyopathies (NICM). We compared mortality using Kaplan-Meier survival curves and Cox proportional hazards models., Results: We identified 1,638 patients with CS and 8,190 propensity matched patients with NICM. The rate of death at 1 and 2 years was similar in patients with CS and patients with NICM (5.2% vs 5.4%, P = 0.75 and 9.0% vs 9.3%, P = 0.72, respectively). After adjusting for other covariates, patients with CS had similar mortality at 2 years after ICD implantations compared with NICM patients (RR 1.03, 95% CI 0.87-1.23). Among patients with CS, multivariable logistic regression identified 6 factors significantly associated with increased 2-year mortality: presence of heart failure (HR 1.92, 95% CI 1.44-3.22), New York Heart Association (NYHA) Class III heart failure (HR 1.68, 95% CI 1.16-2.45), NYHA Class IV heart failure (HR 3.08, 95% CI 1.49-6.39), atrial fibrillation/flutter (HR 1.66, 95% CI 1.17-2.35), chronic lung disease (HR 1.64, 95% CI 1.17-2.29), creatinine >2.0 mg/dL (HR 4.07, 95% CI 2.63-6.30), and paced rhythm (HR 2.66, 95% CI 1.07-6.59)., Conclusion: Mortality following ICD implantation was similar in CS patients compared with propensity matched NICM patients. Presence of heart failure, NYHA class, atrial fibrillation/flutter, chronic lung disease, renal dysfunction, and paced rhythm at time of implantation were all predictors of increased 2-year mortality among CS patients with ICDs., Competing Interests: Declaration of interest Dr Minges and Yongfei Wang receive salary support for analytic services provided to the American College of Cardiology. Dr Lampert reports research grants from Medtronic and Abbott Laboratories/St. Jude Medical and serves on Medtronic advisory board and receives moderate honoraria. Dr Rosenfeld reports fellowship support and stock ownership for Abbott Laboratories and fellowship support from Boston Scientific and Medtronic. Dr Jacoby reports being on the speaker's bureau and an advisory board for Alnylam and participating in ongoing funded research with Alnylam; receiving research grant from Myokardia; serving on an advisory board and steering committee for Myokardia; and receiving consulting fees from Abbott. Dr Curtis has a contract with the American College of Cardiology for his role as Senior Medical Officer, NCDR; receives salary support from the American College of Cardiology, NCDR; receives funding from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and holds equity interest in Medtronic. Dr Miller reports grants from Bracco and Eidos, grants and consulting for Alnylam and Pfizer, outside the submitted work. Dr Freeman reports Consulting/Advisory Board fees from Janssen Pharmaceuticals, Medtronic, Boston Scientific and Biosense Webster. He receives salary/research support from the American College of Cardiology, NCDR and the National Heart Lung and Blood Institute. The remaining authors have no disclosures to report., (Copyright © 2021. Published by Elsevier Inc.)

Importance: Use of dual-chamber implantable cardioverter-defibrillator (ICD) systems among patients without a pacing indication is an example of low-value care given higher procedural risks, higher costs, and little evidence for benefit from an atrial lead. However, variation in the use of dual-chamber systems was present among patients without a pacing indication., Objective: To examine the temporal trends and hospital variation in use of single- and dual-chamber ICD implantation among patients without a pacing indication undergoing first-time ICD implantation., Design, Setting, and Participants: A multicenter cross-sectional study was conducted using the US National Cardiovascular Data Registry ICD Registry. A total of 266 182 patients undergoing initial implantation of a single- or dual-chamber transvenous ICD without a bradycardia pacing indication, class I or II cardiac resynchronization therapy indication, or history of atrial fibrillation or atrial flutter were included. The study was conducted from April 1, 2010, to December 31, 2018; data analysis was performed from October 19, 2020, to January 5, 2022., Exposures: Implantation of a single- or dual-chamber ICD., Main Outcomes and Measures: Temporal trends among patients undergoing single- vs dual-chamber ICDs were determined using the Cochran-Armitage trend test, and hospital-level variation using adjusted hospital median odds ratios was examined., Results: A total of 266 182 patients (single-chamber ICD, 134 925; dual-chamber ICD, 131 257) were included in this analysis; mean (SD) age was 58.0 (14.0) years and 91 990 patients (68.2%) were men. The use of dual-chamber ICDs decreased from 64.7% (n = 15 694) in 2010 to 42.2% (n = 9762) in 2018 (P < .001). Adjusted for patient characteristics, the median hospital-level proportion of single-chamber ICDs increased from 42.9% (95% CI, 42.6%-45.0%) in 2010 to 50.0% (95% CI, 47.8%-51.0%) in 2018. The median odds ratio for the use of dual-chamber ICDs, adjusted for patient characteristics, was 1.6 (95% CI, 1.6-1.8) in 2010 and 1.5 (95% CI, 1.5-1.8) in 2018, indicating decreasing but persistent variation in use., Conclusions and Relevance: In this national study of US patients undergoing first-time ICD implantation without a clinical indication for an atrial lead, the use of dual-chamber devices decreased. However, institutional variability in the use of atrial leads persists, suggesting differences in individual or institutional cultures of real-world practice and opportunity to reduce this low-value practice.

Importance: Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for select patients with atrial fibrillation; however, women have been underrepresented in clinical trials of LAAO, and sex-specific subanalyses are limited., Objective: To evaluate the sex differences in the baseline characteristics of patients undergoing LAAO implant and in the in-hospital outcomes after LAAO implant., Design, Setting, and Participants: A total of 49 357 patients in the National Cardiovascular Data Registry LAAO Registry undergoing LAAO with the Watchman device between January 1, 2016, and June 30, 2019, were included in this study., Exposure: Female or male sex., Main Outcomes and Measures: The primary outcomes were aborted or canceled procedure, major adverse event, any adverse event, prolonged hospital stay longer than 1 day, and death. Unadjusted and multivariable adjusted logistic regression analyses were performed to assess sex differences in in-hospital adverse events., Results: In this cohort study of 49 357 patients (mean [SD] age, 76.1 [8.0] years), 20 388 women (41.3%) and 28 969 (58.7%) men underwent LAAO. Compared with men, women were older and had a higher prevalence of paroxysmal atrial fibrillation, prior stroke, and uncontrolled hypertension but a lower prevalence of congestive heart failure, diabetes, and coronary artery disease. After multivariable adjustment, there were no differences in aborted or canceled procedures between women and men (613 [3.0%] vs 851 [2.9%]; odds ratio [OR] 1.01, 95% CI, 0.90-1.13). Women were more likely than men to experience any adverse event (1284 [6.3%] vs 1144 [3.9%]; P < .001; OR, 1.63; 95% CI, 1.49-1.77; P < .001) or major adverse event (827 [4.1%] vs 567 [2.0%]; P < .001; OR, 2.06; 95% CI, 1.82-2.34; P < .001) owing to pericardial effusion requiring drainage (241 [1.2%] vs 144 [0.5%]) or major bleeding (349 [1.7%] vs 244 [0.8%]). Women were also more likely than men to experience a hospital stay longer than 1 day (3272 [16.0%] vs 3355 [11.6%]; P < .001; adjusted OR, 1.46; 95% CI, 1.38-1.54; P < .001) or death (adjusted OR, 2.01; 95% CI, 1.31-3.09; P = .001), although death was rare and absolute differences were minimal (58 [0.3%] vs 37 [0.1%]; P < .001)., Conclusions and Relevance: This study suggests that, compared with men, women have a significantly higher risk of in-hospital adverse events after LAAO. Further research aimed at risk reduction, particularly strategies to reduce the risk of pericardial effusion and major bleeding, in women undergoing LAAO is warranted.

Background: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited., Objectives: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years., Methods: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates., Results: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA 2 DS 2 -VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare., Conclusions: The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Importance: Trends and in-hospital outcomes associated with early adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the United States have not been described., Objectives: To describe early use of the S-ICD in the United States and to compare in-hospital outcomes among patients undergoing S-ICD vs transvenous (TV)-ICD implantation., Design, Setting, and Participants: A retrospective analysis of 393 734 ICD implants reported to the National Cardiovascular Data Registry ICD Registry, a nationally representative US ICD registry, between September 28, 2012 (US Food and Drug Administration S-ICD approval date), and March 31, 2015, was conducted. A 1:1:1 propensity-matched analysis of 5760 patients was performed to compare in-hospital outcomes among patients with S-ICD with those of patients with single-chamber (SC)-ICD and dual-chamber (DC)-ICD., Main Outcomes and Measures: Analysis of trends in S-ICD adoption as a function of total ICD implants and comparison of in-hospital outcomes (death, complications, and defibrillation threshold [DFT] testing) among S-ICD and TV-ICD recipients., Results: Of the 393 734 ICD implants evaluated during the study period, 3717 were S-ICDs (0.9%). A total of 109 445 (27.8%) of the patients were female; the mean (SD) age was 67.03 (13.10) years. Use of ICDs increased from 0.2% during the fourth quarter of 2012 to 1.9% during the first quarter of 2015. Compared with SC-ICD and DC-ICD recipients, those with S-ICDs were more often younger, female, black, undergoing dialysis, and had experienced prior cardiac arrest. Among 2791 patients with S-ICD who underwent DFT testing, 2588 (92.7%), 2629 (94.2%), 2635 (94.4%), and 2784 (99.7%) were successfully defibrillated (≤65, ≤70, ≤75, and ≤80 J, respectively). In the propensity-matched analysis of 5760 patients, in-hospital complication rates associated with S-ICDs (0.9%) were comparable to those of SC-ICDs (0.6%) (P = .27) and DC-ICD rates (1.5%) (P = .11). Mean (SD) length of stay after S-ICD implantation was comparable to that after SC-ICD implantation (1.1 [1.5] vs 1.0 [1.2] days; P = .77) and less than after DC-ICD implantation (1.1 [1.5] vs 1.2 [1.5] days; P < .001)., Conclusions and Relevance: The use of S-ICDs is rapidly increasing in the United States. Early adoption has been associated with low complication rates and high rates of successful DFT testing despite frequent use in patients with a high number of comorbidities., Competing Interests: Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Friedman has received educational grants from Boston Scientific and St Jude and research grants from the American College of Cardiology’s National Cardiovascular Data Registry (NCDR) and is funded by T 32 training grant HL069749-13 from the National Institutes of Health. Dr Patton served as a site principal investigator for the S-ICD Investigational Device Exemption study, which was funded by Cameron Health, which has since been purchased by Boston Scientific. Dr Russo received research support from Boston Scientific and Medtronic and honoraria or consulting fees from Biotronik, Boston Scientific, Medtronic, and St Jude. Dr Curtis owns stock in Medtronic, receives research funding from Boston Scientific, and receives salary support from the American College of Cardiology to provide data analytic services. No other disclosures were reported.

Background: Management of antithrombotic agents after implantable cardioverter defibrillator implantation is challenging, particularly among patients with atrial fibrillation and coronary artery disease., Methods and Results: Using data from National Cardiovascular Data Registry(®) Implantable Cardioverter Defibrillator Registry(™) linked with Medicare claims data, we identified 25 180 patients with atrial fibrillation and coronary artery disease who underwent implantable cardioverter defibrillator implantation. Patients were categorized into 5 different groups according to antithrombotic agents prescribed at discharge (any 1 antiplatelet agent [A, n=6538], dual antiplatelet therapy [DA, n=3414], warfarin [n=5264], warfarin+A [n=7994], warfarin+DA [n=1970]). We assessed the primary outcomes occurring within 30 days of hospital discharge. Combinations of DA (adjusted hazard ratio [HR]: 1.39; 95% CI: 1.03 to 1.87), warfarin+A (adjusted HR: 1.32; 95% CI: 1.03 to 1.69), and warfarin+DA (adjusted HR: 2.03; 95% CI: 1.49 to 2.77) were associated with a higher bleeding risk. The risk of major adverse cardiovascular events was higher in patients discharged with A (adjusted HR: 1.69; 95% CI: 1.33 to 2.16), DA (adjusted HR: 2.17; 95% CI: 1.66 to 2.83), and DA+warfarin (adjusted HR: 1.61; 1.16 to 2.24). There was no association between postdischarge antithrombotic agents and thromboembolic events or device-related complications., Conclusions: Short-term bleeding risk and major adverse cardiovascular events differ with usage patterns of antithrombotic agents, while the risk of thromboembolic events and device-related complications is relatively constant. These data may help clinicians balance risks and benefits when choosing antithrombotic therapy following implantable cardioverter defibrillator implantation., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

AimsNo prior study has been adequately powered to evaluate real-world safety outcomes in those receiving adjunctive ablation lesions beyond pulmonary vein isolation (PVI). We sought to evaluate characteristics and in-hospital complications among patients undergoing PVI with and without adjunctive lesions.Methods and resultsPatients in the National Cardiovascular Data Registry AFib Ablation Registry undergoing first-time atrial fibrillation (AF) ablation between 2016 and 2020 were identified and stratified into paroxysmal (PAF) and persistent AF, and separated into PVI only, PVI + cavotricuspid isthmus (CTI) ablation, and PVI + adjunctive (superior vena cava isolation, coronary sinus, vein of Marshall, atypical atrial flutter lines, other). Adjusted odds of adverse events were calculated using multivariable logistic regression. A total of 50 937 patients [PAF: 30 551 (60%), persistent AF: 20 386 (40%)] were included. Among those with PAF, there were no differences in the adjusted odds of complications between PVI + CTI or PVI + adjunctive when compared with PVI only. Among persistent AF, PVI + adjunctive was associated with a higher risk of any complication [3.0 vs. 4.5%, odds ratio (OR) 1.30, 95% confidence interval (CI) 1.07-1.58] and major complication (0.8 vs. 1.4%, OR 1.56, 95% CI 1.10-2.21), while no differences were observed in PVI + CTI compared with PVI only. Overall, there was high heterogeneity in adjunctive lesion type, and those receiving adjunctive lesions had a higher comorbidity burden.ConclusionAdditional CTI ablation was common without an increased risk of complications. Adjunctive lesions other than CTI are commonly performed in those with more comorbidities and were associated with an increased risk of complications in persistent AF, although the current analysis is limited by high heterogeneity in adjunctive lesion set type.

The impact of preprocedure imaging on the safety and effectiveness of left atrial appendage occlusion (LAAO) remains unclear. This study sought to determine the rates of use of preprocedure computed tomography (CT)/cardiac magnetic resonance (CMR) and its association with safety and effectiveness of LAAO procedures. The National Cardiovascular Data Registry LAAO Registry was used to evaluate patients who underwent attempted LAAO with the WATCHMAN and WATCHMAN FLX devices between January 1, 2016, and June 30, 2021. Safety and effectiveness of LAAO procedures was compared by use vs nonuse of preprocedural CT/CMR. Outcomes of interest included implantation success (deployment and release of device), device success (device released with peridevice leak <5 mm), and procedure success (device released with peridevice leak <5 mm and no in-hospital major adverse events [MAE]). Multivariable logistic regression was used to assess the relationship between preprocedure imaging and outcomes. Preprocedure CT/CMR was used for 18.2% (n = 20,851) of the 114,384 procedures in this study. CT/CMR use was more common among government and university hospitals and hospitals in the Midwest and South; it was less common among patients with uncontrolled hypertension, with abnormal renal function, and without prior thromboembolism. Overall rates of implantation success, device success, and procedure success were 93.4%, 91.2%, and 89.4%, respectively. Preprocedure CT/CMR was independently associated with an increased likelihood of implantation success (OR: 1.08; 95% CI: 1.00-1.17), device success (OR: 1.10; 95% CI: 1.04-1.16), and procedural success (OR: 1.07; 95% CI: 1.02-1.13). MAE were uncommon (2.3%) and not associated with use of preprocedure CT/CMR (OR: 1.02; 95% CI: 0.92-1.12). Preprocedure CT/CMR was associated with an increased likelihood of successful LAAO implantation; however, the magnitude of benefit appears small and it was not associated with MAE. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking.Objectives: The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD.Methods: The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models.Results: A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161).Conclusions: In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients. [ABSTRACT FROM AUTHOR]

Objectives: We sought to describe the incidence of acute lead dislodgements and the consequences of these events in patients enrolled in the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter-Defibrillator (ICD) Registry. Background: Lead dislodgements are common adverse events in patients undergoing ICD implants. Little is known regarding who is at risk and the consequences of these events. Methods: Patients enrolled between April 2006 and September 2008 were included. Acute lead dislodgement was defined as movement of the lead requiring another procedure for repositioning before discharge. Results: Acute dislodgement occurred in 2,628 of 226,764 patients. Univariate variables associated with dislodgements included older age, female sex, and patients with atrial fibrillation, chronic lung disease, cerebrovascular disease, nonischemic cardiomyopathy, and lower ejection fractions (all p < 0.002). After multivariate adjustment, factors associated with an increased risk for dislodgement included New York Heart Association functional class IV heart failure, atrial fibrillation/flutter, having a cardiac resynchronization therapy-defibrillator device, and procedures performed by physicians trained under alternative pathways. A teaching/training hospital setting was not a factor (p = 0.64). Acute dislodgements had increased odds for other adverse events including cardiac arrest, cardiac tamponade, device infection, pneumothorax, and in-hospital death even after adjustment for potential confounders (all p < 0.0001). Conclusions: Acute lead dislodgements occur more often in patients with more comorbidities and in patients undergoing implants by nonelectrophysiology-trained implanters. These events were strongly associated with increased odds for in-hospital death. [Copyright &y& Elsevier]