Management of spontaneous coronary artery dissection: Trends over time.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is an increasingly recognized cause of acute coronary syndrome. Guidance regarding the optimal management of patients with SCAD has been published over the past 10 years, but the impact on clinical practice has not been evaluated. The present study aims to examine if approaches to invasive management, medical therapy, and vascular imaging have changed over time. METHODS: This is a retrospective cohort study of 157 patients treated for SCAD between 2005 and 2019 at an academic health system in Philadelphia, Pennsylvania. We aimed to examine change in management over time, including rates of coronary revascularization, discharge medications, and vascular imaging. RESULTS: Conservative management of SCAD increased over time from 35% before 2013 to 89% in 2019, p < 0.001. Revascularization was associated with younger age, pregnancy-associated SCAD, and lesions of the left main artery, left anterior descending artery, and multiple vessels, p < 0.05 for all. Partial imaging for extracoronary vascular abnormalities ranged from 33% before 2013 to 71% in 2018, p = 0.146. The rate of comprehensive vascular imaging (cross-sectional head to pelvis imaging) remained low in all time categories (10-18%) and did not change over time. Patients who underwent comprehensive imaging were more likely to be diagnosed with fibromuscular dysplasia (FMD) compared to those with partial imaging (63% vs 15%, p < 0.001). CONCLUSION: Management of spontaneous coronary artery dissection has changed over time. More patients are being managed conservatively and undergo screening for extracoronary vascular abnormalities such as FMD. Future efforts should focus on improving rates of comprehensive vascular screening.

Stent-Based Gene Delivery for Coronary Disease.

Percutaneous coronary interventions (PCI) are the mainstay for treatment of advanced coronary disease. A majority of PCI involve deployment of a stent in the affected vascular segment. This chapter introduces the concept of using stents as a platform for delivering gene therapies to the vasculature with the overarching aim of mitigating in-stent restenosis (ISR), late stent thrombosis (LST), and neoatherosclerosis (NA), a triad of delayed complications that reduce the overall success rate of PCI. The chapter provides a detailed methodology for coatless reversible attachment of adenoviral (Ad) and adeno-associated viral (AAV) vectors to the metal stent struts along with representative in vitro and in vivo results.

Stent-based delivery of AAV2 vectors encoding oxidation-resistant apoA1.

In-stent restenosis (ISR) complicates revascularization in the coronary and peripheral arteries. Apolipoprotein A1 (apoA1), the principal protein component of HDL possesses inherent anti-atherosclerotic and anti-restenotic properties. These beneficial traits are lost when wild type apoA1(WT) is subjected to oxidative modifications. We investigated whether local delivery of adeno-associated viral (AAV) vectors expressing oxidation-resistant apoA1(4WF) preserves apoA1 functionality. The efflux of 3H-cholesterol from macrophages to the media conditioned by endogenously produced apoA1(4WF) was 2.1-fold higher than for apoA1(WT) conditioned media in the presence of hypochlorous acid emulating conditions of oxidative stress. The proliferation of apoA1(WT)- and apoA1(4FW)-transduced rat aortic smooth muscle cells (SMC) was inhibited by 66% ± 10% and 65% ± 11%, respectively, in comparison with non-transduced SMC (p < 0.001). Conversely, the proliferation of apoA1(4FW)-transduced, but not apoA1(WT)-transduced rat blood outgrowth endothelial cells (BOEC) was increased 41% ± 5% (p < 0.001). Both apoA1 transduction conditions similarly inhibited basal and TNFα-induced reactive oxygen species in rat aortic endothelial cells (RAEC) and resulted in the reduced rat monocyte attachment to the TNFα-activated endothelium. AAV2-eGFP vectors immobilized reversibly on stainless steel mesh surfaces through the protein G/anti-AAV2 antibody coupling, efficiently transduced cells in culture modeling stent-based delivery. In vivo studies in normal pigs, deploying AAV2 gene delivery stents (GDS) preloaded with AAV2-eGFP in the coronary arteries demonstrated transduction of the stented arteries. However, implantation of GDS formulated with AAV2-apoA1(4WF) failed to prevent in-stent restenosis in the atherosclerotic vasculature of hypercholesterolemic diabetic pigs. It is concluded that stent delivery of AAV2-4WF while feasible, is not effective for mitigation of restenosis in the presence of severe atherosclerotic disease.

Impact Of Cirrhosis On 90-Day Outcomes After Percutaneous Coronary Intervention (from A Nationwide Database).

Patients with cirrhosis often have concomitant coronary artery disease and require percutaneous coronary intervention (PCI). PCI in cirrhotics can be associated with significant risks due to thrombocytopenia, possible coagulopathies, bleeding, and renal failure. Longer term risks of PCI in cirrhotics have not been well studied. Our study seeks to evaluate the 90-day outcomes of PCI in patients with cirrhosis. Patients receiving PCI were identified from the Nationwide Readmissions Database from 2010 to 2014 and stratified by the presence of co-morbid cirrhosis. The total mortality during index admission and 90-day readmissions as well as the readmissions rate were examined. Adverse events including bleeding, stroke, kidney injury, and vascular complications were also compared. Patients with cirrhosis had a significantly higher number of co-morbidities. The cirrhosis group had a higher overall 90-day mortality (10.3% vs 2.5%, p < 0.01), including during the index hospitalization (7.0% vs 1.8%, p < 0.01), as well as a higher 90-day readmission rate (38.2% vs 20.2%, p < 0.01). Patients with cirrhosis also had higher frequencies of overall 90-day adverse events (44.7% vs 17.7%, p < 0.01), including gastrointestinal bleeding (15.3% vs 2.7%, p < 0.01) and acute kidney injury (28.4% vs 10.1%, p < 0.01). In conclusion, patients with cirrhosis face a significantly higher risk of adverse outcomes including mortality, readmissions, and adverse events in the 90 days after hospitalization for PCI compared with the general population.

One-Year Outcomes of Percutaneous Coronary Intervention in Patients with End-Stage Liver Disease.

BACKGROUND: Patients with cirrhosis and coronary artery disease (CAD) are at high risk for morbidity during surgical revascularization so they are often referred for complex percutaneous coronary intervention (PCI). Percutaneous coronary intervention in the cirrhotic population also has inherent risks; however, quantifiable data on long-term outcomes are lacking. METHODS: Patients with angiographically significant CAD and cirrhosis were identified from the catheterization lab databases of the University of Pennsylvania Health System between 2007 and 2015. Outcomes were obtained from the medical record and telephonic contact with patients/families. RESULTS: Percutaneous coronary intervention was successfully performed in 42 patients (51 PCIs). Twenty-nine patients with significant CAD were managed medically (36 angiograms). The primary outcome (a composite of mortality, subsequent revascularization, and myocardial infarction) was not significantly different between the 2 groups during a follow-up period at 1 year (PCI: 50%, Control: 40%, P = .383). In the PCI group, a composite adverse outcome rate that included acute kidney injury (AKI), severe bleed, and peri-procedural stroke was elevated (40%), with severe bleeding occurring after 23% of PCI events and post-procedural AKI occurring after 26% of events. The medical management group had significantly fewer total matched adverse outcomes (17% vs 40% in the PCI group, P = .03), with severe bleeding occurring after 11% of events and AKI occurring after 6% of events. Increased risk of adverse events following PCI was associated with severity of liver disease by Child-Pugh class. CONCLUSIONS: Percutaneous coronary intervention in patients with cirrhosis is associated with an elevated risk of adverse events, including severe bleeding and AKI.

Prospective CYP2C19 Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial.

BACKGROUND: CYP2C19 loss-of-function alleles impair clopidogrel effectiveness after percutaneous coronary intervention, but the clinical impact of implementing CYP2C19 genotyping in a real-world setting is unknown. The purpose of the study was to determine whether returning CYP2C19 genotype results along with genotype-guided pharmacotherapy recommendations using a rapid turnaround test would change antiplatelet prescribing following percutaneous coronary intervention.The primary outcome was the rate of prasugrel or ticagrelor prescribing in each arm. Secondary outcomes included agreement to the genotype-guided recommendations. METHODS: At the time of percutaneous coronary intervention, participants were randomly assigned to prospective rapid point-of-care genotyping of CYP2C19 major alleles (*2, *3, *17) via salivary swab (genotyped group) or no genotyping (usual care) to guide antiplatelet drug selection. Interventional cardiologists at 2 cardiac catheterization laboratories within the same health system were provided genotype information along with genotype-guided pharmacotherapy recommendations. RESULTS: A total of 504 participants were randomized, 249 to the genotyped and 255 to the usual care group. The participants were primarily men (73%); age, 63±10 years; and 50% had acute coronary syndromes. In the genotyped group, 28% were carriers of loss-of-function alleles (*2, *3). The use of prasugrel or ticagrelor was significantly higher in the genotyped group compared with the usual care group (30% versus 21%; odds ratio, 1.60 [95% CI, 1.07-2.42]; P=0.03). Within the genotyped group, 53% of loss-of-function allele carriers were started on prasugrel/ticagrelor, while 47% were started on clopidogrel. CONCLUSIONS: In a randomized controlled trial of clinical CYP2C19 genotyping implementation, pharmacogenetic test results significantly influenced antiplatelet drug prescribing; however, almost half of CYP2C19 loss-of-function carriers continued to receive clopidogrel. Interventional cardiologists consider both clinical and genetic factors when selecting antiplatelet therapy following percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT02508116.

Comparative Outcomes After Percutaneous Coronary Intervention Among Black and White Patients Treated at US Veterans Affairs Hospitals.

Importance: Current comparative outcomes among black and white patients treated with percutaneous coronary intervention (PCI) in the Veterans Affairs (VA) health system are not known. Objective: To compare outcomes between black and white patients undergoing PCI in the VA health system. Design, Setting, and Participants: This study compared black and white patients who underwent PCI between October 1, 2007, and September 30, 2013, at 63 VA hospitals using data recorded in the VA Clinical Assessment, Reporting, and Tracking System for Cardiac Catheterization Laboratories (CART-CL) program. A generalized linear mixed model with a random intercept for site assessed the relative difference in odds of outcomes between black and white patients. The setting was integrated institutionalized hospital care. Excluded were all patients of other races or those with multiple listed races and those with missing data regarding race or the diagnostic cardiac catheterization. The dates of analysis were January 7, 2016, to April 17, 2017. Exposure: Percutaneous coronary intervention at a VA hospital. Main Outcomes and Measures: The primary outcome was 1-year mortality. Secondary outcomes were 30-day all-cause readmission rates, 30-day acute kidney injury, 30-day blood transfusion, and 1-year readmission rates for myocardial infarction. In addition, variations in procedural and postprocedural care were examined, including the use of intravascular ultrasound, optical coherence tomography, fractional flow reserve measurements, bare-metal stents, postprocedural medications, and radial access. Results: A total of 42 391 patients (13.3% black and 98.4% male; mean [SD] age, 65.2 [9.1] years) satisfied the inclusion and exclusion criteria. In unadjusted analyses, black patients had higher rates of 1-year mortality (7.1% vs 5.9%, P < .001) as well as secondary outcomes of 30-day acute kidney injury (20.8% vs 13.8%, P < .001), 30-day blood transfusion (3.4% vs 2.7%, P < .01), and 1-year readmission rates for myocardial infarction (3.3% vs 2.7%, P = .01) compared with white patients. After adjustment for demographics, comorbidities, and procedural characteristics, odds for 1-year mortality (odds ratio, 1.04; 95% CI, 0.90-1.19) were not different between black and white patients. There were also no differences in secondary outcomes with the exception of a higher rate of adjusted 30-day acute kidney injury (odds ratio, 1.22; 95% CI, 1.10-1.36). Conclusions and Relevance: While black patients had a higher rate of mortality than white patients in unadjusted analyses, race was not independently associated with 1-year mortality among patients undergoing PCI in VA hospitals.

Robotic-assisted percutaneous coronary intervention.

Performance of percutaneous coronary intervention (PCI) is associated with several occupational hazards including radiation exposure and musculoskeletal injury. Current methods to mitigate these risks range from suspended radiation suits to adjustable lead-lined glass shields. Robotic-assisted PCI is a novel approach to PCI that utilizes remote-controlled technology to manipulate catheters thereby significantly reducing radiation exposure to the operator and catheterization laboratory staff. Although limited, current evidence indicates that robotic-assisted PCI is associated with a high technical success rate and may have additional advantages over conventional PCI, such as a decreased incidence of geographical miss. However, as the technology is nascent, further studies including larger, randomized controlled trials are needed to expand on the long-term clinical and safety outcomes.

Text mining applied to electronic cardiovascular procedure reports to identify patients with trileaflet aortic stenosis and coronary artery disease.

BACKGROUND: Interrogation of the electronic health record (EHR) using billing codes as a surrogate for diagnoses of interest has been widely used for clinical research. However, the accuracy of this methodology is variable, as it reflects billing codes rather than severity of disease, and depends on the disease and the accuracy of the coding practitioner. Systematic application of text mining to the EHR has had variable success for the detection of cardiovascular phenotypes. We hypothesize that the application of text mining algorithms to cardiovascular procedure reports may be a superior method to identify patients with cardiovascular conditions of interest. METHODS: We adapted the Oracle product Endeca, which utilizes text mining to identify terms of interest from a NoSQL-like database, for purposes of searching cardiovascular procedure reports and termed the tool "PennSeek". We imported 282,569 echocardiography reports representing 81,164 individuals and 27,205 cardiac catheterization reports representing 14,567 individuals from non-searchable databases into PennSeek. We then applied clinical criteria to these reports in PennSeek to identify patients with trileaflet aortic stenosis (TAS) and coronary artery disease (CAD). Accuracy of patient identification by text mining through PennSeek was compared with ICD-9 billing codes. RESULTS: Text mining identified 7115 patients with TAS and 9247 patients with CAD. ICD-9 codes identified 8272 patients with TAS and 6913 patients with CAD. 4346 patients with AS and 6024 patients with CAD were identified by both approaches. A randomly selected sample of 200-250 patients uniquely identified by text mining was compared with 200-250 patients uniquely identified by billing codes for both diseases. We demonstrate that text mining was superior, with a positive predictive value (PPV) of 0.95 compared to 0.53 by ICD-9 for TAS, and a PPV of 0.97 compared to 0.86 for CAD. CONCLUSION: These results highlight the superiority of text mining algorithms applied to electronic cardiovascular procedure reports in the identification of phenotypes of interest for cardiovascular research.

Retinal pathology is associated with increased blood-retina barrier permeability in a diabetic and hypercholesterolaemic pig model: Beneficial effects of the LpPLA2 inhibitor Darapladib.

Using a porcine model of diabetes mellitus and hypercholesterolaemia, we previously showed that diabetes mellitus and hypercholesterolaemia is associated with a chronic increase in blood-brain barrier permeability in the cerebral cortex, leading to selective binding of immunoglobulin G and deposition of amyloid-beta1-42 peptide in pyramidal neurons. Treatment with Darapladib (GlaxoSmithKline, SB480848), an inhibitor of lipoprotein-associated phospholipase-A2, alleviated these effects. Here, investigation of the effects of chronic diabetes mellitus and hypercholesterolaemia on the pig retina revealed a corresponding increased permeability of the blood-retina barrier coupled with a leak of plasma components into the retina, alterations in retinal architecture, selective IgG binding to neurons in the ganglion cell layer, thinning of retinal layers due to cell loss and increased glial fibrillary acidic protein expression in Müller cells, all of which were curtailed by treatment with Darapladib. These findings suggest that chronic diabetes mellitus and hypercholesterolaemia induces increased blood-retina barrier permeability that may be linked to altered expression of blood-retina barrier-associated tight junction proteins, claudin and occludin, leading to structural changes in the retina consistent with diabetic retinopathy. Additionally, results suggest that drugs with vascular anti-inflammatory properties, such as Darapladib, may have beneficial effects on eye diseases strongly linked to vascular abnormalities such as diabetic retinopathy and age-related macular degeneration.

Bioresorbable Scaffolds for Coronary Artery Disease.

PURPOSE OF REVIEW: The purpose of this review is to present an overview of the recent evidence regarding the use of bioresorbable scaffolds in percutaneous coronary intervention. RECENT FINDINGS: Bioresorbable scaffolds represent a potentially unique engineering solution to the problems associated with metallic stents. The Absorb everolimus-eluting bioresorbable scaffold has been the most extensively tested of this class and is currently Food and Drug Administration-approved for use in the USA. While early studies suggested that it has comparable overall efficacy as compared to drug-eluting metallic stents, they also demonstrated a significantly increased risk of stent thrombosis. Bioresorbable scaffolds may be comparable to drug-eluting stents, though associated with an increased risk of stent thrombosis. They are a nascent technology with several competitive product designs in development and continued iterative technological improvements are expected over the next several years.

Is multivessel intervention in ST-elevation myocardial infarction associated with early harm? Insights from observational data.

OBJECTIVES: Appraisal of evidence for recommendations for multivessel coronary intervention in ST-elevation myocardial infarction (STEMI). BACKGROUND: Multi-vessel disease (MVD) is common in patients with ST-segment elevation myocardial infarction (STEMI). Published observational data has suggested that multi-vessel percutaneous coronary intervention (MVPCI) at the time of initial hospitalization for STEMI may be harmful in contrast to evidence from recent randomized trials. METHODS: We queried the nationwide inpatient sample (NIS) to identify characteristics of hemodynamically stable STEMI patients undergoing MVPCI on index admission and subsequent mortality in raw and adjusted models. To compare our results with published observational data, we searched multiple databases from inception through July 15, 2015. RESULTS: From 2009-2012, excluding cardiac arrest or cardiogenic shock, there were 11,454 MVPCI and 157,011 single-vessel PCI (SVPCI) for STEMI patients in the NIS. Compared to SVPCI, MVPCI on index admission was not associated with higher in-hospital mortality in unadjusted or propensity-adjusted models (MVPCI 1.91% vs. SVPCI 5.32%, P < 0.001). Our analysis of index hospitalization MVPCI versus infarct-related artery (IRA)-only PCI in the meta-analysis of observational studies (19 studies, N = 76,399) demonstrated no difference in in-hospital mortality with MVPCI compared with IRA-only PCI (OR 0.87, 95% CI 0.65-1.17; P = 0.37), with confirmation in study sequential analysis. CONCLUSIONS: MVPCI is uncommonly performed during index hospitalization in hemodynamically stable STEMI patients, likely reflecting widespread adherence to prior guidelines. Based on observational data, there does not appear to be early harm associated with MVPCI on the index admission in hemodynamically stable STEMI patients. © 2016 Wiley Periodicals, Inc.

The vulnerable artery: early and rapid deposition of lipid in coronary arteries is associated with subsequent development of thin-cap fibroatheromas.

AIMS: We aimed to determine whether intravascular ultrasound (IVUS) and near infrared spectroscopy (NIRS) could identify arteries which would subsequently develop a thin-cap fibroatheroma (TCFA). METHODS AND RESULTS: Three-vessel angiography, IVUS and NIRS evaluations were performed at three, six and nine months after induction of diabetes mellitus and hypercholesterolaemia in 13 Yorkshire pigs (n=37 arteries). In vivo total arterial plaque plus media (P+M) area, echo-attenuated plaque (AP) area by IVUS, and lipid core burden index (LCBI) by NIRS were compared to histology at nine months. P+M mean area increased over time (3 vs. 6 months p<0.01; 6 vs. 9 months p<0.01), as did the AP area and mean LCBI between three and six months (p<0.01). There were 69 TCFAs within 18 arteries. The mean LCBI at six months was greater in arteries containing a TCFA (77.8±17.4 vs. 34.3±11.4; p=0.04) as was the ∆LCBI from three to six months (55.3±16.9 vs. 3.3±16.0; p=0.03). Arteries which contained TCFA at nine months had greater AP area by IVUS at six months (p=0.007). CONCLUSIONS: The early and persistent accumulation of total arterial lipid detected by NIRS was associated with the future development of TCFAs.

Sex Differences in Outcomes Following Percutaneous Coronary Intervention According to Age.

BACKGROUND: Women <50 years of age with coronary artery disease may represent a group at higher risk for recurrent ischemic events after percutaneous coronary intervention (PCI); however, no long-term, multicenter outcomes assessment exists in this population. METHODS AND RESULTS: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated the association of sex and age on cardiovascular-related outcomes in 10,963 patients (3797 women, 394 <50 years) undergoing PCI and followed for 5 years. Death, myocardial infarction, coronary artery bypass graft surgery, and repeat PCI were primary outcomes comprising major adverse cardiovascular events. Although procedural success rates were similar by sex, the cumulative rate of major adverse cardiovascular events at 1 year was higher in young women (27.8 versus 19.9%; P=0.003), driven largely by higher rates of repeat revascularizations for target vessel or target lesion failure (coronary artery bypass graft surgery: 8.9% versus 3.9%, P<0.001, adjusted hazard ratio 2.4, 95% confidence interval 1.5-4.0; PCI: 19.0% versus 13.0%, P=0.005, adjusted hazard ratio 1.6, 95% confidence interval 1.2-2.2). At 5 years, young women remained at higher risk for repeat procedures (coronary artery bypass graft surgery: 10.7% versus 6.8%, P=0.04, adjusted hazard ratio 1.71, 95% confidence interval 1.01-2.88; repeat PCI [target vessel]: 19.7% versus 11.8%, P=0.002, adjusted hazard ratio 1.8, 95% confidence interval 1.24-2.82). Compared with older women, younger women remained at increased risk of major adverse cardiovascular events, whereas all outcome rates were similar in older women and men. CONCLUSIONS: Young women, despite having less severe angiographic coronary artery disease, have an increased risk of target vessel and target lesion failure. The causes of this difference deserve further investigation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00005677.

Phase I study of multi-gene cell therapy in patients with peripheral artery disease.

UNLABELLED: Alternative treatment strategies for claudication are needed and cell-based therapies designed to induce angiogenesis are promising. The purpose of this report was to conduct a Phase I safety, dose-escalating, non-randomized, open-label study of autologous, fully differentiated venous endothelial and smooth muscle cells called MultiGeneAngio (MGA) for claudication due to peripheral artery disease. Twelve subjects, at two centers, received a single intra-arterial infusion of a suspension of equal amounts of transduced autologous venous smooth muscle cells expressing vascular endothelial growth factor (VEGF165) and endothelial cells expressing angiopoietin-1 (Ang-1) (Cohort 1: 1 × 10(7), Cohort 2: 2 × 10(7), Cohort 3: 5 × 10(7), Cohort 4: 7 × 10(7)). The treatment was given unblinded and in the more symptomatic lower extremity. Transduced cells were tested for in vitro doubling time, telomerase activity, and gene expression. The main outcomes were clinical safety and tolerability. Other safety measures included ankle-brachial index (ABI) and walking time on a treadmill. All subjects were male (mean age 60 ± 5 years) including 25% with diabetes mellitus. At 1-year follow-up, there was one serious adverse event possibly related to MGA. Safety endpoints including VEGF and Ang-1 plasma protein levels were within normal ranges in all subjects. The mean maximal walking time increased from baseline to 1 year and the index limb ABI was unchanged, indicating no safety concerns. MGA, an autologous, transduced, cell-based therapy was well tolerated and safe in this Phase I study. Further evaluation is warranted in randomized human studies. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00390767.

Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database.

IMPORTANCE: The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. OBJECTIVES: To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. DATA SOURCES: For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. DATA EXTRACTIONS AND SYNTHESIS: Data were abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE data set. MAIN OUTCOMES AND MEASURES: Procedural adverse events and procedural success. RESULTS: In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures). In the FDA MAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. CONCLUSIONS AND RELEVANCE: This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA exclusion. Formal, controlled investigations into the safety and efficacy of the device for this indication are warranted.