Association of Hospital Procedural Volume With Outcomes of Percutaneous Left Atrial Appendage Occlusion

ObjectivesThe aim of this study was to examine the association between percutaneous left atrial appendage occlusion (LAAO) procedural volume and in-hospital outcomes.BackgroundSeveral studies have demonstrated an inverse volume-outcome relationship for patients undergoing invasive cardiac procedures. Whether a similar association exists for percutaneous LAAO remains unknown.MethodsPatients undergoing LAAO in 2017 were identified in the Nationwide Readmissions Database. Hospitals were categorized into 3 groups on the basis of tertiles of annual procedural volume: low (5 to 15 cases/year), medium (17 to 31 cases/year), and high (32 to 211 cases/year). Multivariate hierarchical logistic regression and restricted cubic spline analyses were performed to examine the association of hospital LAAO volume and outcomes. The primary outcome was in-hospital major adverse events (MAE), defined as a composite of mortality, stroke or transient ischemic attack, bleeding or transfusion, vascular complications, myocardial infarction, systemic embolization, and pericardial effusion or tamponade requiring pericardiocentesis or surgery.ResultsThis study included 5,949 LAAO procedures performed across 196 hospitals with a median annual procedural volume of 41 (interquartile range: 25 to 67). Low-volume hospitals had higher rates of in-hospital MAE (9.5% vs. 5.6%; p < 0.001), stroke or transient ischemic attack (2.1% vs. 1.3%; p = 0.049), and bleeding or transfusion (6.1% vs. 3.5%; p = 0.002) compared with high-volume hospitals. No differences were noted for other components of MAE and index length of stay. On multivariate analysis, higher procedural volume was associated with lower rates of in-hospital MAE, with an adjusted odds ratio for medium versus low volume of 0.69 (95% confidence interval: 0.46 to 1.04; p = 0.08) and for high versus low volume of 0.55 (95% confidence interval: 0.37 to 0.82; p = 0.003).ConclusionsHigher hospital procedural volume is associated with better outcomes for LAAO procedures. Further studies are needed to determine if this relationship persists for long-term outcomes.     

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.     

Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices

BackgroundProcedural 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.ObjectivesThe aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device.MethodsThe 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.ResultsThe 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).ConclusionsTranscatheter 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.     

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)     

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.     

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.     

Initial Findings From the National Cardiovascular Data Registry of Atrial Fibrillation Ablation Procedures

BackgroundThe National Cardiovascular Data Registry (NCDR) AFib Ablation Registry was created to assess real-world prevalence, demographic characteristics, procedural management, and outcomes of patients undergoing atrial fibrillation (AF) ablation procedures.ObjectivesThe goal of this study was to characterize the patient, hospital, and physician characteristics and in-hospital outcomes related to AF ablation in the first 5 years of the registry.MethodsThis paper describes the AFib Ablation Registry structure and governance, outcome assessment processes, data quality, and data collection processes. The characteristics of the patient population, hospitals, and in-hospital outcomes are also described.ResultsA total of 76,219 patients were included in the registry between January 2016 and December 2020 (mean age 65.5 ± 10.3 years, 65.2% male, 55.8% paroxysmal AF, mean CHA₂DS₂-VASc score 2.7 ± 1.6) treated by 708 physicians in 162 hospitals. Successful isolation of all pulmonary veins was achieved in 92.4% of patients. The prevalence of any complication during procedural admission was 2.50% and major complication was 0.9%, including significant bradycardia in 0.47%, heart failure in 0.47%, and pericardial effusion requiring intervention in 0.44%. Hospitalization >1 day occurred in 11.8% of patients, and in-hospital death was rare (n = 41 [0.05%]).ConclusionsThe NCDR AFib Ablation Registry is the largest multicenter, prospective cohort study of patients undergoing catheter ablation worldwide. Results in the first 5 years showed that successful pulmonary vein isolation is achieved in the majority of patients, with a low rate of complications. Future studies from the registry will assess practice trends, evaluate treatment patterns associated with different patient outcomes, and support development of evidence-based guidelines.     

The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study

ObjectivesThe aim of this study was to evaluate the impact of CHA₂DS₂-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study.BackgroundBaseline CHA₂DS₂-VASc and HAS-BLED scores have been validated in atrial fibrillation patients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO).MethodsSubjects were stratified according to CHA₂DS₂-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee.ResultsSubjects were considered at low (n = 156), moderate (n = 715), and high (n = 215) risk for ischemic stroke, corresponding to CHA₂DS₂-VASc scores of <3, 3 to 5, and ≥6, respectively. The annual rates of ischemic stroke were 1.1%, 2.0%, and 3.5%, respectively. When compared with the predicted rate, LAAO reduced the risk of ischemic stroke by 56%, 69%, and 68%. Device-related thrombus occurred in 0.7%, 1.5%, and 3.0% of subjects at low, moderate, and high risk for ischemic stroke, respectively. The HAS-BLED score was ≤3 in 629 subjects and >3 in 456 subjects, respectively. Non-peri-procedural major bleeding was reduced by 11% and 9% compared with predicted rates in the low and high bleeding risk groups, respectively.ConclusionsLAAO with the Amplatzer Amulet reduced the risk of ischemic stroke compared with the predicted rate, with a greater magnitude among patients at high thromboembolic risk without increasing the bleeding risk. (Amplatzer™Amulet™ Post-Market Study [Amulet™PMS]; NCT02447081)     

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)     

The Relationship Between Hospital Stroke Center Designation and TVT Reported Stroke: The Michigan TAVR Experience

BackgroundThe 30-day rate of stroke after transcatheter aortic valve replacement (TAVR) has been suggested as a hospital quality metric. Thirty-day stroke rates for nonsurgical, high, and moderate-risk TAVR trials were 3.4% to 6.1%, whereas those in the national Transcatheter Valve Therapy (TVT) Registry for the same patient population were much lower. Hospital comprehensive stroke center (CSC) is the highest designation for integrated acute stroke recognition, management, and care.ObjectivesUsing Michigan TVT data, we assessed whether in-hospital post-TAVR stroke rates varied between CSC and non-CSC institutions.MethodsTVT data submitted from the 22 Michigan Transcatheter Aortic Valve Replacement Collaborative participating institutions between January 1, 2016, and June 30, 2019, were included (N = 6,231). Bayesian hierarchical regression models accounting for patient clinical characteristics and hospital clustering were fitted to assess the association between hospital CSC accreditation and in-hospital post-TAVR stroke. Adjusted ORs and 95% credible intervals were estimated. The University of Michigan Institutional Review Board has waived the need for the approval of studies based on the data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry.ResultsThere were 3,882 (62.3%) patients at 9 CSC sites and 2,349 (37.7%) patients at 13 non-CSC sites. CSC sites had significantly higher rates of in-hospital post-TAVR stroke (CSC: 2.65% vs non-CSC: 1.15%; P < 0.001). After adjustment, patients who underwent TAVR at a CSC hospital had a significantly higher risk of in-hospital stroke (adjusted OR: 2.21; 95% CI: 1.03-4.62). However, CSC designation was not significantly associated with other important post-TAVR clinical outcomes including 30-day mortality.ConclusionsReported Michigan Transcatheter Aortic Valve Replacement Collaborative TVT stroke rates were significantly higher at sites with Joint Hospital Commission stroke designation status; however, other reported important clinical outcomes did not differ significantly based on this designation. CSC designation is a possible factor in stroke rate detection differences between TAVR institutions and might be a factor in the observed differences in stroke rates between TAVR trials and those reported in TVT. In addition, these data suggest that comparison between hospitals based on post-TAVR stroke rates is potentially problematic.     

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.     

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.     

Impact of Hospital Procedural Volume on Outcomes After Endovascular Revascularization for Critical Limb Ischemia

ObjectivesThe aim of this study was to evaluate the interaction between hospital endovascular lower extremity revascularization (eLER) volume and outcomes after eLER for critical limb ischemia (CLI).BackgroundThere is a paucity of data on the relationship between hospital procedural volume and outcomes of eLER for CLI.MethodsThe authors queried the Nationwide Readmission Database (2013-2015) for hospitalized patients who underwent eLER for CLI. Hospitals were divided into tertiles according to annual eLER volume: low volume (<100 eLER procedures), moderate volume (100-550 eLER procedures), and high volume (>550 eLER procedures). Stepwise multivariable regression models were used. The main outcomes were in-hospital mortality and 30-day readmission with major adverse limb events, defined as the composite of amputation, acute limb ischemia, or repeat revascularization.ResultsAmong 145,785 hospitalizations for eLER for CLI, 5,199 (3.6%) were at low-volume eLER hospitals, 27,857 (19.1%) at moderate-volume eLER hospitals, and 112,728 (77.3%) at high-volume eLER hospitals. On multivariable analysis, there was no difference with regard to in-hospital mortality among moderate-volume hospitals (adjusted odds ratio [OR]: 0.78; 95% CI: 0.60-1.01) and high-volume hospitals (adjusted OR: 0.84; 95% CI: 0.64-1.05) compared with low-volume hospitals. There was lower risk of in-hospital major amputation (adjusted OR: 0.82; 95% CI: 0.70-0.96) and minor amputation at high- versus low-volume hospitals. The length of hospital stay was shorter and discharges to nursing facilities were fewer among moderate- and high-volume hospitals compared with low-volume hospitals. Compared with low-volume hospitals, eLER for CLI at high-volume hospitals had a lower risk for 30-day readmission with major adverse limb events (adjusted OR: 0.83; 95% CI: 0.70-0.99), while there was no difference among moderate-volume hospitals (adjusted OR: 0.92; 95% CI: 0.77-1.10).ConclusionsThis nationwide observational analysis suggests that annual eLER volume does not influence in-hospital mortality after eLER for CLI. However, high eLER volume (>550 eLER procedures) was associated with better rates of limb preservation after eLER for CLI.     

Implementation of High-Sensitivity Cardiac Troponin Assays in the United States

BackgroundFew data exist regarding the implementation of high-sensitivity cardiac troponin (hs-cTn) assays in the United States since their approval.ObjectivesThis study sought to explore trends in hs-cTn assay implementation over time and assess the association of their use with in-hospital cardiac testing and outcomes.MethodsThe study examined trends in implementation of hs-cTn assays among participating hospitals in the National Cardiovascular Data Registry Chest Pain-MI [Myocardial Infarction] Registry from January 1, 2019 through September 30, 2021. Associations among hs-cTn use, use of in-hospital diagnostic imaging, and patient outcomes were assessed using generalized estimating equation models with logistic or gamma distributions.ResultsAmong 550 participating hospitals (N = 251,000), implementation of hs-cTn assays increased from 3.3% in the first quarter of 2019 to 32.6% in the third quarter of 2021 (P_trend < 0.001). Use of hs-cTn was associated with more echocardiography among persons with non–ST-segment elevation acute coronary syndrome (NSTE-ACS; 82.4% vs 75.0%; adjusted odds ratio: 1.43; 95% CI: 1.19-1.73) but not among low-risk chest pain individuals. Use of hs-cTn was associated with less invasive coronary angiography among low-risk patients (3.7% vs 4.5%; adjusted odds ratio: 0.73; 95% CI: 0.58-0.92) but similar use for patients with NSTE-ACS. There was no association between hs-cTn use and noninvasive stress testing or coronary computed tomography angiography testing. Among individuals with NSTE-ACS, hs-cTn use was not associated with revascularization or in-hospital mortality. Use of hs-cTn was associated with a shorter length of stay (median 47.6 hours vs 48.0 hours; ratio: 0.94; 95% CI: 0.90-0.98).ConclusionsImplementation of hs-cTn among U.S. hospitals is increasing, but most U.S. hospitals continue to use less sensitive assays. The use of hs-cTn was associated with modestly shorter length of stay, greater use of echocardiography for NSTE-ACS, and less use of invasive angiography among low-risk patients.     

Defining Percutaneous Coronary Intervention Complexity and Risk: An Analysis of the United Kingdom BCIS Database 2006-2016

ObjectivesThe authors used the BCIS (British Cardiovascular Intervention Society) database to define the factors associated with percutaneous coronary intervention (PCI) procedural complexity.BackgroundComplex high-risk indicated percutaneous coronary intervention (CHIP-PCI) is an emerging concept that is poorly defined.MethodsThe BCIS (British Cardiovascular Intervention Society) database was used to study all PCI procedures in the United Kingdom 2006-2016. A multiple logistic regression model was developed to identify variables associated with in-hospital major adverse cardiac or cerebrovascular events (MACCE) and to construct a CHIP score. The cumulative effect of this score on patient outcomes was examined.ResultsA total of 313,054 patients were included. Seven patient factors (age ≥80 years, female sex, previous stroke, previous myocardial infarction, peripheral vascular disease, ejection fraction <30%, and chronic renal disease) and 6 procedural factors (rotational atherectomy, left main PCI, 3-vessel PCI, dual arterial access, left ventricular mechanical support, and total lesion length >60 mm) were associated with increased in-hospital MACCE and defined as CHIP factors. The mean CHIP score/case for all PCIs increased significantly from 1.06 ± 1.32 in 2006 to 1.49 ± 1.58 in 2016 (P < 0.001 for trend). A CHIP score of 5 or more was present in 2.5% of procedures in 2006 increasing to 5.3% in 2016 (P < 0.001 for trend). Overall in-hospital MACCE was 0.6% when the CHIP score was 0 compared with 1.2% with any CHIP factor present (P < 0.001). As the CHIP score increased, an exponential increase in-hospital MACCE was observed. The cumulative MACCE for procedures associated with a CHIP score 4+ or above was 3.2%, and for a CHIP score 5+ was 4.4%. All other adverse clinical outcomes were more likely as the CHIP score increased.ConclusionsSeven patient factors and 6 procedural factors were associated with adverse in-hospital MACCE and defined as CHIP factors. Use of a CHIP score might be a future target for risk modification.     

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.     

Clinical Characteristics and Prognostic Importance of Left Ventricular Apical Aneurysms in Hypertrophic Cardiomyopathy

BackgroundLeft ventricular (LV) apical aneurysms in hypertrophic cardiomyopathy (HCM) are a recognized risk marker for adverse cardiovascular events. There is variable practice among clinicians and discordance between international guidelines regarding treatment recommendations and prognostication for this important phenotype.ObjectivesThe authors sought to describe the morphology, clinical course, and risk of adverse events in a large single-center cohort of HCM patients with LV apical aneurysms.MethodsThis study analyzed 160 HCM patients with an LV apical aneurysm who were evaluated in our dedicated HCM clinic between January 1997 and April 2021.ResultsMean age was 59.1 ± 13.6 years, and 71% of these patients were male. Mean aneurysm size was 1.77 ± 1.04 cm. Over 6.2 ± 4.8 years, 14 (9%) patients had a sudden cardiac death (SCD) event, including appropriate therapy from an implantable cardioverter-defibrillator (ICD) or resuscitation from cardiac arrest (annualized event rate 1.77%/y), 39 (24%) had either a thromboembolic stroke or apical thrombus formation (2.9%/y), and 14 (9%) developed LV systolic dysfunction with an ejection fraction (EF) <50% (1.28%/y). HRs for SCD, stroke or thrombus, and EF <50% per 1-cm increase in aneurysm size were 1.69 (P = 0.007), 1.60 (P = 0.0002), and 1.63 (P = 0.01), respectively. Aneurysm size ≥2 cm was associated with a 5-year SCD rate of 9.7%, compared with 2.9% for aneurysm size <2 cm (log-rank P = 0.037). This subgroup also had higher risk of stroke/thrombus formation (HR: 2.20; P = 0.002), with an annualized event rate of 2.7%/year. A total of 39 (24%) patients reached the combined end point of SCD, stroke, or LV dysfunction (2.12%/y) with an HR of 1.47/cm increase in aneurysm size (P = 0.003) and an HR of 2.22 for patients with aneurysm size ≥2 cm (P = 0.02).ConclusionsIncreasing aneurysm size confers poorer prognosis. Aneurysm size ≥2 cm should alert potential consideration for prophylactic anticoagulation and primary prevention ICDs.     

Retrograde Chronic Total Occlusion Percutaneous Coronary Intervention via Saphenous Vein Graft

ObjectivesThe aim of this study was to examine the use of saphenous vein grafts (SVGs) for retrograde crossing during chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundThe use of SVGs for retrograde crossing during CTO PCI has received limited study.MethodsA total of 1,615 retrograde CTO PCIs performed between 2012 and 2019 at 25 centers were examined. Clinical, angiographic, and technical characteristics and procedural outcomes were compared among retrograde cases via SVGs (SVG group) versus other collateral vessels (non-SVG group).ResultsRetrograde CTO PCI via SVGs was performed in 189 cases (12%). Patients in the SVG group were older (mean age 70 ± 9 years vs. 64 ± 10 years; p < 0.01) and had higher rates of prior myocardial infarction (62% vs. 51%; p < 0.01) and prior PCI (81% vs. 70%; p < 0.01). They were more likely to have moderate or severe calcification (81% vs. 65%; p < 0.01) and moderate or severe tortuosity (53% vs. 44%; p = 0.02) and had similar J-CTO (Multicenter CTO Registry in Japan) scores (3.2 ± 1.0 vs. 3.1 ± 1.1; p = 0.13) but higher PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores (4.7 ± 1.7 vs. 3.1 ± 1.1; p < 0.01). Technical (85% vs. 78%; p = 0.04) and procedural (81% vs. 74%; p = 0.04) success rates were higher in the SVG group, with no difference in in-hospital major adverse events (6.4% vs. 4.4%; p = 0.22). Contrast volume was lower in the SVG group (225 ml [173 to 325 ml] vs. 292 ml [202 to 400 ml]; p < 0.01).ConclusionsUse of SVGs for retrograde crossing is associated with higher rates of technical and procedural success and similar rates of in-hospital major adverse cardiac events compared with retrograde CTO PCI via other collateral vessels.     

Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial

ObjectivesThe aim of this study was to compare transradial access (TRA) with transfemoral access (TFA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundTRA reduces the risk for vascular access complications but may make complex PCI, such as CTO PCI, more challenging.MethodsFORT CTO (Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion) (NCT03265769) was a prospective, noninferiority, randomized controlled study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural success, defined as technical success without any in-hospital major adverse cardiovascular events. The secondary study endpoint was major access-site complications.ResultsBetween 2017 and 2021, 610 of 800 patients referred for CTO PCI at 4 centers were randomized to TRA (n = 305) or TFA (n = 305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 0.1 vs 2.2 ± 0.1; P = 0.279), PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (1.3 ± 0.9 vs 1.1 ± 1.0; P = 0.058) and PROGRESS CTO complication (2.4 ± 1.8 vs 2.3 ± 1.8; P = 0.561) scores and use of the retrograde approach (11% vs 14%; P = 0.342) were similar in the TRA and TFA groups. TRA was noninferior to TFA for procedural success (84% vs 86%; P = 0.563) but had fewer access-site complications (2.0% vs 5.6%; P = 0.019). There was no difference between TFA and TRA in procedural duration, contrast volume, or radiation dose.COnclusionsTRA was noninferior to TFA for CTO PCI but had fewer access-site complications.     

Clinical Impact of Contralateral Carotid Occlusion in Patients Undergoing Carotid Artery Revascularization

BackgroundThe presence of a contralateral carotid occlusion (CCO) is an established high-risk feature for patients undergoing carotid endarterectomy (CEA) and is traditionally an indication for carotid artery stenting (CAS). Recent observational data have called into question whether CCO remains a high-risk feature for CEA.ObjectivesThe purpose of this study was to determine the clinical impact of CCO among patients undergoing CEA and CAS in a contemporary nationwide registry.MethodsAll patients undergoing CEA or CAS from 2007 to 2019 in the NCDR CARE (National Cardiovascular Data Registry Carotid Artery Revascularization and Endarterectomy) and PVI (Peripheral Vascular Intervention) registries were included. The primary exposure was the presence of CCO. The outcome was a composite of in-hospital death, stroke, and myocardial infarction. Multivariable logistic regression and inverse-probability of treatment weighting were used to compare outcomes.ResultsAmong 58,423 patients who underwent carotid revascularization, 4,624 (7.9%) had a CCO. Of those, 68.9% (n = 3,185) underwent CAS and 31.1% (n = 1,439) underwent CEA. The average age of patients with CCO was 69.5 ± 9.7 years, 32.6% were women, 92.8% were Caucasian, 51.7% had a prior transient ischemic attack or stroke, and 45.4% presented with symptomatic disease. Over the study period, there was a 41.7% decrease in the prevalence of CCO among patients who underwent carotid revascularization (p < 0.001), but CAS remained the primary revascularization strategy. Unadjusted composite outcome rates were lower in patients with CCO after CAS (2.1%) than CEA (3.6%). Following adjustment, CCO was associated with a 71% increase in the odds of an adverse outcome after CEA (95% confidence interval: 1.27 to 2.30; p < 0.001) compared with no increase after CAS (adjusted odds ratio: 0.94; 95% confidence interval: 0.72 to 1.22; p = 0.64).ConclusionsCCO remains an important predictor of increased risk among patients undergoing CEA, but not CAS.