Clinical Outcomes Associated With Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulation in Atrial Fibrillation

ObjectivesThis study sought to investigate clinical outcomes associated with left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs) in patients with high-risk atrial fibrillation (AF).BackgroundLAAO has been shown to be noninferior to warfarin for stroke prevention in AF. However, anticoagulation with DOACs is now preferred over warfarin as thromboprophylaxis in AF.MethodsPatients with AF enrolled in the Amulet Observational Registry (n = 1,088) who had successful LAAO with the Amplatzer Amulet device (n = 1,078) were compared with a propensity score–matched control cohort of incident AF patients (n = 1,184) treated by DOACs identified from Danish national patient registries. Propensity score matching was based on the covariates of the CHA₂DS₂-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65–74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores for predicting stroke and bleeding. The primary outcome was a composite of ischemic stroke, major bleeding (Bleeding Academic Research Consortium ≥3), or all-cause mortality, and follow-up was 2 years.ResultsAF patients treated with LAAO had a significantly lower risk of the primary composite outcome as compared with patients treated with DOACs (hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.49 to 0.67). Total events and event rates per 100 patient-years were (LAAO vs. DOACs) 256 vs. 461 and 14.5 vs. 25.7, respectively. The risk of ischemic stroke was comparable between groups (HR: 1.11; 95% CI: 0.71 to 1.75), while risk of major bleeding (HR: 0.62; 95% CI: 0.49 to 0.79) and all-cause mortality (HR: 0.53; 95% CI: 0.43 to 0.64) were significantly lower in patients treated with LAAO.ConclusionsAmong high-risk AF patients, LAAO in comparison with DOACs may have similar stroke prevention efficacy but lower risk of major bleeding and mortality.     

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States

ObjectivesThe aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.BackgroundThe 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.MethodsPatients 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.ResultsThe study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA₂DS₂-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.ConclusionsThis 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.     

Cierre de la orejuela izquierda por ictus pese a la anticoagulación oral (ictus resistente): resultados del registro Amplatzer Cardiac Plug

Introduction and objectivesDespite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment.MethodsWe analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications.ResultsA total of 115 patients (11%) with RS were identified. The CHA₂DS₂-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5 ± 1.5 vs 4.3 ± 1.6; P < .001; 3.9 ± 1.3 vs 3.1 ± 1.2; P < .001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P = .1). With a mean clinical follow-up of 16.2 ± 12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction).ConclusionsPatients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients.     

Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation

BackgroundPercutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)–related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown.ObjectivesThis study sought to compare DOACs with LAAC in high-risk patients with AF.MethodsLeft Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA₂DS₂-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat.ResultsA high-risk patient cohort (CHA₂DS₂-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients.ConclusionsAmong patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944)     

The NCDR Left Atrial Appendage Occlusion Registry

BackgroundLeft 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.ObjectivesThe 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.MethodsThe 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.ResultsA 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 CHA₂DS₂-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.ConclusionsThe 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.     

Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial

BackgroundWomen have higher rates of acute complications after left atrial appendage occlusion (LAAO). However, data on long-term safety and effectiveness are limited.ObjectivesThe aim of this study was to examine sex-specific short- and long-term outcomes after LAAO in the Amulet IDE (Amplatzer? Amulet? LAA Occluder) trial.MethodsThe following outcomes were compared between men and women: in-hospital complications, device-related outcomes (peridevice leak at 45 days and device-related thrombus at 18 months), and long-term clinical outcomes (death, thromboembolism, and bleeding). Subanalyses for the interaction between sex and device type were performed.ResultsA total of 1,833 patients underwent attempted device implantation (917 with the Amulet and 916 with the Watchman), of whom 734 were women (40%). Device success was 97.4% in men and 97.1% in women (P = 0.60). Rates of major in-hospital adverse events were higher in women (4.4% vs 1.9%; P < 0.01), driven by major bleeding (3.7% vs 1.0%; P < 0.01) and pericardial effusion requiring intervention (2.0% vs 0.5%; P < 0.01). Peridevice leak and device-related thrombus were similar in men and women (18.3% vs 18.9% [P = 0.78] and 3.3% vs 5.0% [P = 0.10], respectively). There were no differences between men and women in rates of ischemic stroke or systemic embolism (2.6% vs 2.6%; P = 0.98), transient ischemic attack (1.3% vs 1.6%; P = 0.69), hemorrhagic stroke (0.5% vs 0.4%; P = 0.88), major bleeding (10.1% vs 10.9%; P = 0.49), cardiovascular death (4.3% vs 3.5%; P = 0.45), or all-cause death (8.9% vs 6.9%; P = 0.16).ConclusionsIn the Amulet IDE trial, long-term clinical outcomes including effectiveness following LAAO were comparable in men and women despite the higher rates of in-hospital complications due to major bleeding and pericardial effusion in women. (Amplatzer? Amulet? LAA Occluder Trial [Amulet IDE]; NCT02879448)     

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use

ObjectivesThe authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device.BackgroundThe CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation.MethodsPatients with atrial fibrillation at high stroke risk (CHA₂DS₂-VASc score ≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6 months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45 days and 1 year.ResultsTwenty-two patients (63.7% with CHA₂DS₂-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45 days, 1 significant leak (≥5 mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization.ConclusionsThis first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.     

Half-Dose Direct Oral Anticoagulation Versus Standard Antithrombotic Therapy After Left Atrial Appendage Occlusion

ObjectivesThis study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation.BackgroundNo consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure.MethodsAfter successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events.ResultsOverall, 555 patients (mean age 75 ± 8 years, 63% male; median CHA₂DS₂-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 months (IQR: 12-15 months). DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P = 0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P = 0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (HR: 9.8; 95% CI: 2.3-40.7; P = 0.002).ConclusionsAfter successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk of the composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based, antithrombotic therapy.     

Riesgo hemorrágico y embólico de los pacientes con fibrilación auricular y cáncer

Introduction and objectivesThe impact of cancer on clinical outcomes in patients with atrial fibrillation (AF) is unclear. The aim of this study was to assess how cancer influences the prediction and risk of embolic and hemorrhagic events in patients with AF.MethodsThe study population comprised 16 056 patients from a Spanish health area diagnosed with AF between 2014 and 2018. Of these, 1137 (7.1%) had a history of cancer. During a median follow-up of 4.9 years, we assessed the relationship between cancer and bleeding and embolic events by competing risk analysis, considering death as a competing risk.ResultsNo association was detected between an increased risk of embolic events and cancer overall (sHR, 0.73; 95%CI, 0.41-1.26), active cancer, or any subgroup of cancer. However, cancer was associated with an increased risk of bleeding, although only in patients with active cancer (sHR, 1.42; 95%CI, 1.20-1.67) or prior radiotherapy (sHR, 1.40; 95%CI, 1.19-1.65). Both the CHA₂DS₂-VASc and HAS-BLED scores showed suboptimal performance to predict embolic and bleeding risk (c-statistic < 0.50), respectively, in nonanticoagulated patients with active cancer. The ratio between the increase in bleeding and the decrease in embolisms with anticoagulation was similar in patients with and without cancer (5.6 vs 7.8; P < .001).ConclusionsCancer was not associated with an increased risk of embolic events in AF patients, only with an increased risk of bleeding. However, active cancer worsened the ability of the CHA₂DS₂-VASc and HAS-BLED scores to predict embolic and bleeding events, respectively, in nonanticoagulated patients.Full English text available from:www.revespcardiol.org/en     

Procedural and Short-Term Results With the New Watchman FLX Left Atrial Appendage Occlusion Device

ObjectivesThis study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts).BackgroundThe new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis.MethodsA total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program.ResultsMean age was 75.4 ± 8.9 years, and CHA₂DS₂-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred.ConclusionsLAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.     

Valvular and Nonvalvular Atrial Fibrillation in Patients Undergoing Transcatheter Aortic Valve Replacement

ObjectivesThe aim of this study was to investigate the impact of valvular and nonvalvular atrial fibrillation (AF) in patients undergoing transcatheter aortic valve replacement (TAVR).BackgroundAF has been associated with adverse clinical outcomes after TAVR. However, the differential impact of valvular as opposed to nonvalvular AF has not been investigated.MethodsIn a retrospective analysis of a prospective registry, valvular AF was defined as AF in the setting of concomitant mitral stenosis or the presence of a mitral valve prosthesis. The presence of mitral stenosis was determined by pre-procedural echocardiography. The primary endpoint was a composite of cardiovascular death or disabling stroke at 1 year after TAVR.ResultsAmong 1,472 patients undergoing TAVR between August 2007 and June 2018, AF was recorded in 465 patients (31.6%) and categorized as nonvalvular in 376 (25.5%) and valvular in 89 (6.0%). AF scores including HAS-BLED, CHADS₂, and CHA₂DS₂-VASc were comparable between patients with nonvalvular and valvular AF. The primary endpoint occurred in 9.3% of patients with no AF, in 14.5% of patients with nonvalvular AF (hazard ratio: 1.57; 95% confidence interval: 1.12 to 2.20; p = 0.009), and in 24.2% of patients with valvular AF (hazard ratio: 2.75; 95% confidence interval: 1.71 to 4.41; p < 0.001). Valvular AF conferred an increased risk for cardiovascular death or disabling stroke compared with nonvalvular AF (hazard ratio: 1.77; 95% confidence interval: 1.07 to 2.94; p = 0.027).ConclusionsThe presence of valvular AF in patients undergoing TAVR increased the risk for cardiovascular death or disabling stroke compared with both no AF and nonvalvular AF. (SWISS TAVI Registry; NCT01368250)     

Incidence,Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study

ObjectivesThis study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).BackgroundDRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.MethodsA total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation.ResultsDevice implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04).ConclusionsFollowing LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.     

First Experience of Transcatheter Leak Occlusion With Detachable Coils Following Left Atrial Appendage Closure

ObjectivesThe aim of this study was to assess the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with incomplete left atrial appendage (LAA) closure.BackgroundIncomplete LAA closure is common after interventional therapies targeting the LAA, potentially hindering effective thromboembolic prevention. Detachable coils have found a wide range of applications for transcatheter vascular occlusion and embolization procedures.MethodsThirty consecutive patients at high thromboembolic risk with clinically relevant residual leaks (mean age 72 ± 9 years, 73.3% men, mean CHA₂DS₂-VASc score 4.4 ± 1.4, mean HAS-BLED score 3.6 ± 0.8) underwent percutaneous closure of the LAA patency using embolization coils. Transesophageal echocardiography was performed at 60 ± 15 days post-procedure.ResultsLAA closure had been previously attempted with the Watchman device in 25 patients, the Amulet device in 2 patients, and the LARIAT device in 3 patients. Baseline transesophageal echocardiography documented moderate and severe leaks in 20 (66.7%) and 10 (33.3%) patients, respectively. After a single procedure, 25 patients (83.3%) showed complete LAA sealing or minimal leaks. Five patients (16.7%) had moderate residual leaks; 3 patients of them were offered repeat procedures. Mean procedure and fluoroscopy times were 76 ± 41 min and 21 ± 14 min, respectively; the mean volume of iodinated contrast medium used was 80 ± 47 ml. Coil deployment was successful in all cases. The overall complication rate was 6.1%. After a median follow-up period of 54 days (range 43 to 265 days) and an average of 1.1 procedures/patient, transesophageal echocardiography revealed complete LAA sealing or negligible residual leaks in 28 patients (93.3%; 25 with no residual leak, 3 patients with minimal to mild residual leaks) and moderate residual leaks in 2 patients (6.7%).ConclusionsTranscatheter LAA leak occlusion using endovascular coils appears to be a safe, effective, and promising approach in patients at high echo time risk with incomplete LAA closure. (Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures [TREASURE]; NCT03503253)     

Cierre de orejuela izquierda en pacientes mayores de 85 años: seguridad y eficacia del registro EWOLUTION

Introduction and objectivesElderly patients with atrial fibrillation are at greater risk of both cardioembolic events and major bleeding than younger patients. Left atrial appendage occlusion (LAAO) could be an attractive alternative for these patients, but there are limited data on outcomes with LAAO in patients ≥ 85 years old. The aim of the present study was to assess the safety and efficacy of LAAO in patients ≥ 85 years old.MethodsA total of 1025 patients included in the EWOLUTION registry who underwent LAAO were analyzed and 84 patients ≥ 85 years old were identified and compared with the younger cohort.ResultsPatients ≥ 85 years old had higher estimated stroke and hemorrhagic risks than younger patients (CHA₂DS₂-VASc: 5.2 ± 1.2 vs 4.4 ± 1.6, P < .0001; HAS-BLED: 2.7 ± 1.1 vs 2.3 ± 1.2; P = .003; ≥ 85 years vs < 85 years). Procedural success was high and similar in both groups (98.8% vs 98.5%; P = .99). There were no differences in 7-day device- or procedure-related adverse event rates (2.6% in ≥ 85 years vs 3.1% in < 85 years; P = .80). Despite the higher baseline stroke risk, there was no difference at follow-up between the groups in the annualized stroke rate (0.8/100 patient-years in ≥ 85 years vs 1.3/100 patient-years in < 85 years; P = .649).ConclusionsLAAO in patients ≥ 85 years is safe and effective even though these patients are at high risk for embolic and hemorrhagic events. LAAO may be a reasonable alternative to oral anticoagulation in these patients.     

Amiloidosis cardiaca y cierre de aurícula izquierda. Estudio CAMYLAAC

Introduction and objectivesTransthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA.MethodsComparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis of CA.ResultsWe studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA₂DS₂-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P = .283), hemorrhagic stroke (2.5% and 0.8% in the control group; P = .284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P < .001) but this difference was unrelated to hemorrhagic complications or ischemic stroke.ConclusionsLAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile.Full English text available from:www.revespcardiol.org/en     

Fibrilación auricular en pacientes con COVID-19. Utilidad de la puntuación CHA2DS2-VASc: un análisis del registro internacional HOPE COVID-19

Introduction and objectivesCoronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2. Atrial fibrillation (AF) is common in acute situations, where it is associated with more complications and higher mortality.MethodsAnalysis of the international HOPE registry (NCT04334291). The objective was to assess the prognostic information of AF in COVID-19 patients. A multivariate analysis and propensity score matching were performed to assess the relationship between AF and mortality. We also evaluated the impact on mortality and embolic events of the CHA₂DS₂-VASc score in these patients.ResultsAmong 6217 patients enrolled in the HOPE registry, 250 had AF (4.5%). AF patients had a higher prevalence of cardiovascular risk factors and comorbidities. After propensity score matching, these differences were attenuated. Despite this, patients with AF had a higher incidence of in-hospital complications such as heart failure (19.3% vs 11.6%, P = .021) and respiratory insufficiency (75.9% vs 62.3%, P = .002), as well as a higher 60-day mortality rate (43.4% vs 30.9%, P = .005). On multivariate analysis, AF was independently associated with higher 60-day mortality (hazard ratio, 1.234; 95%CI, 1.003-1.519). CHA₂DS₂-VASc score acceptably predicts 60-day mortality in COVID-19 patients (area ROC, 0.748; 95%CI, 0.733-0.764), but not its embolic risk (area ROC, 0.411; 95%CI, 0.147-0.675).ConclusionsAF in COVID-19 patients is associated with a higher number of complications and 60-day mortality. The CHA₂DS₂-VASc score may be a good risk marker in COVID patients but does not predict their embolic risk.     

Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials

ObjectivesThe 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.BackgroundPatients undergoing LAAO in clinical practice generally have more comorbidities than trial participants.MethodsPropensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models.ResultsA 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.ConclusionIn 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)     

Peridevice Leak After Transcatheter Left Atrial Appendage Occlusion: An Analysis of the Amulet IDE Trial

BackgroundPeridevice leak (PDL) is a limitation of left atrial appendage occlusion.ObjectivesThe aim of this study was to assess the incidence of and outcomes associated with PDL in the Amulet IDE (AMPLATZER? Amulet? LAA Occluder Trial) randomized controlled trial.MethodsPatients with atrial fibrillation at increased stroke risk were randomly assigned to undergo either Amulet (dual occlusive mechanism) or Watchman 2.5 (single occlusive mechanism) device implantation. Transesophageal echocardiography was performed at 45 days and 12 months postprocedure. Clinically significant PDL was defined as ≥3 mm. The primary endpoint was ischemic stroke or systemic embolism, and the secondary endpoint was stroke, systemic embolism, or cardiovascular death. The Kaplan-Meier method was used to estimate 18-month cumulative event rates landmarked at day 45 postprocedure.ResultsA total of 1,593 patients underwent successful left atrial appendage occlusion and had an evaluable transesophageal echocardiographic studies at 45 days. The dual–occlusive mechanism device provided superior closure (defined as leak <3 mm) compared with the single–occlusive mechanism device at 45 days (88.9% vs 74.1%; P < 0.01) and 12 months (90.5% vs. 78.3%; P < 0.01). Through 18 months, PDL was associated with a higher, but not statistically significant, risk for the primary endpoint (3.6% vs 1.8%; adjusted HR: 1.98; 95% CI: 0.93-4.19; P = 0.07) and a statistically significantly higher risk for the secondary endpoint (8.1% vs. 4.7%; adjusted HR: 1.66; 95% CI: 1.02-2.69; P = 0.04).ConclusionsThe dual–occlusive mechanism device provided superior closure compared with the single–occlusive mechanism device at both 45 days and 1 year postprocedure. PDL ≥3 mm was associated with a significantly increased 18-month risk for the composite of stroke, systemic embolism, or cardiovascular death. Completeness of closure of the left atrial appendage has important implications for patient outcomes. (AMPLATZER? Amulet? LAA Occluder Trial [Amulet IDE]; NCT02879448)     

Low vitamin D levels predict left atrial thrombus in nonvalvular atrial fibrillation

Background and aimsWe determined the association between left atrial (LA) thrombus occurrence and a non-classic risk marker, plasma levels of vitamin D, in atrial fibrillation (AF) patients on continuous non-vitamin K antagonist oral anticoagulant (NOAC) therapy for ≥4 weeks. Low levels of plasma 25-hydroxy vitamin D (25-OHD) are predictive of fatal stroke. Vitamin D has anticoagulant effects on the coagulation cascade, which are indirectly targeted by NOAC therapy. The impact of plasma levels of vitamin D on the rate of LA thrombus detected by transesophageal echocardiography (TEE) in AF patients is unknown.Methods and resultsWe enrolled 201 (133 female) AF patients who were using continuous NOAC therapy for ≥4 weeks. All patients underwent transthoracic and TEE examination. Serum concentrations of 25-OHD, C-reactive protein (CRP) levels, CHA₂DS₂-VASc scores and parameters, LA size, and left ventricle ejection fraction (LVEF) were examined before the TEE procedure. LA thrombus occurrence was independently associated with serum levels of 25-OHD (OR: 0.884; 95% CI: 0.839–0.932; P < 0.001), LA diameter (OR: 1.120; 95% CI: 1.038–1.209; P = 0.003), and LVEF(OR: 0.944; 95% CI: 0.896–0.995; P = 0.032). Dense spontaneous echo contrast (SEC) presence was also inversely associated with 25-OHD concentrations.ConclusionsLow 25-OHD levels, as a non-classic risk factor, were independently and significantly associated with dense SEC and LA thrombus occurrence in AF patients under NOAC therapy, as well as LA enlargement and decreased LVEF. Further large-scale studies are needed to explain the role of vitamin D deficiency, or efficacy of replacement, on LA thrombus occurrence.     

Peridevice Leak Following Amplatzer Left Atrial Appendage Occlusion: Cardiac Computed Tomography Classification and Clinical Outcomes

ObjectivesThis study aimed to investigate cardiac computed tomography (CT) and transesophageal echocardiography (TEE) peridevice leak (PDL) assessments, and the clinical relevance of PDL.BackgroundPDL assessment is integral during follow-up after left atrial appendage (LAA) occlusion. Comparative studies of TEE and cardiac CT are sparse, and the clinical relevance of PDL is uncertain.MethodsThis was a single-center observational study of consecutive patients undergoing LAA occlusion with Amplatzer devices (Amplatzer Cardiac Plug/Amulet) between 2010 and 2018 (N = 415). Patients with both 8-week CT and TEE were included for analysis (n = 346). Images were analyzed by blinded investigators (K.K. and A.S.). PDL on cardiac CT was classified from grade 1 to 3, based on PDL at the device disc, device lobe, and LAA contrast patency. Primary clinical outcome was a composite of ischemic stroke, transient ischemic attack, systemic embolism, or all-cause death.ResultsPDL was present in 110 patients (32%) by TEE, with 29 (8%) >3 mm. By cardiac CT, 210 patients (61%) had PDL at the disc, with contrast patency in 204 patients (59%). A grade 3 PDL (gap at disc, lobe, and LAA contrast patency) was present in 63 patients (18%). Bland-Altman analysis showed poor agreement between CT and TEE for leak sizing. CT and TEE detected PDL was not significantly associated with worse outcome, hazard ratio: 1.82 (95 % confidence interval: 0.95 to 3.50); p = 0.07 and hazard ratio: 1.43 (95% confidence interval: 0.74 to 2.76); p = 0.28, respectively.ConclusionsPDL occurrence is substantially higher with CT compared with TEE, with a large discrepancy between modalities in leak quantification. A novel CT-based classification is proposed, yet PDL was not associated with worse clinical outcome.