The NCDR Left Atrial Appendage Occlusion Registry Freeman, James V.; Varosy, Paul; Price, Matthew J. ...
Journal of the American College of Cardiology,
04/2020, Letnik:
75, Številka:
13
Journal Article
Recenzirano
Odprti dostop
Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.
The purpose of this ...study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.
The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.
A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean 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.
The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.
Display omitted
An analysis of national cardiovascular data showed that median door-to-balloon times for primary PCI declined from 83 minutes in 2005 to 67 minutes in 2009, whereas in-hospital mortality remained ...unchanged during this period.
Primary percutaneous coronary intervention (PCI) is currently the preferred treatment for acute ST-segment elevation myocardial infarction. Previous observational studies have shown a strong association between prompt performance of primary PCI, as assessed in terms of the door-to-balloon time (the interval from the patient's arrival at the hospital to inflation of the balloon to restore flow), and reduced mortality.
1
–
3
On the basis of these data, current joint clinical practice guidelines of the American College of Cardiology and the American Heart Association (ACC–AHA) endorse a door-to-balloon time of 90 minutes or less as the goal, giving it a Class I (highest . . .
BACKGROUND:Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in ...Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump).
METHODS:From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levelstime period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs).
RESULTS:Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008–2016) versus the pre-Impella era (years 2004–2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with deathodds ratio, 1.24 (95% CI, 1.13–1.36); bleedingodds ratio, 1.10 (95% CI, 1.00–1.21); and strokeodds ratio, 1.34 (95% CI, 1.18–1.53), although a similar, nonsignificant result was observed for acute kidney injuryodds ratio, 1.08 (95% CI, 1.00–1.17).
CONCLUSIONS:Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.
BACKGROUND:Transvenous lead extraction is an integral part of management of patients with cardiovascular implantable electronic devices. Real-world incidence and predictors of perioperative ...complications in extractions involving implantable cardioverter-defibrillator leads have not been described in detail.
METHODS AND RESULTS:Data from the National Cardiovascular Data Registry Implantable Cardioverter-Defibrillator Registry were analyzed. Lead extraction was defined as removal of leads implanted for >1 year. Predictors of major perioperative complications for all extraction procedures (11 304) and for high-voltage lead (8362, 74%), across 762 centers, were analyzed using univariate and multivariate logistic regression. Major complication occurred in 258 (2.3%) extraction procedures. Of these 258 with a complication, 41 (16%) required urgent cardiac surgery. Of these 41, 14 (34%) died during surgery. Among the total 98 (0.9%) deaths reported, 18 (0.16% of total) occurred during transvenous lead extraction. In multivariable logistic regression analysis, female sex, admission other than electively for procedure, ≥3 leads extracted, longer implant duration, dislodgement of other leads, and patient’s clinical status requiring lead extraction (infection/perforation) were associated with increased risk of complications. Smaller lead diameter, flat versus round coil shape, and greater proximal surface coil area were multivariate predictors of major perioperative complications specific to high-voltage leads.
CONCLUSIONS:The rate of major complications and mortality with transvenous lead extraction is similar in the real-world outcomes to that reported in recent single-center studies from high-volume centers. There is significant risk of urgent cardiac surgery, which carries a high mortality, and planning for appropriate cardiothoracic surgery backup is imperative.
IMPORTANCE: Appropriate Use Criteria for Coronary Revascularization were developed to critically evaluate and improve patient selection for percutaneous coronary intervention (PCI). National trends ...in the appropriateness of PCI have not been examined. OBJECTIVE: To examine trends in PCI utilization, patient selection, and procedural appropriateness following the introduction of Appropriate Use Criteria. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, longitudinal, cross-sectional analysis of patients undergoing PCI between July 1, 2009, and December 31, 2014, at hospitals continuously participating in the National Cardiovascular Data Registry CathPCI registry over the study period. MAIN OUTCOMES AND MEASURES: Proportion of nonacute PCIs classified as inappropriate at the patient and hospital level using the 2012 Appropriate Use Criteria for Coronary Revascularization. RESULTS: A total of 2.7 million PCI procedures from 766 hospitals were included. Annual PCI volume of acute indications was consistent over the study period (377 540 in 2010; 374 543 in 2014), but the volume of nonacute PCIs decreased from 89 704 in 2010 to 59 375 in 2014. Among patients undergoing nonacute PCI, there were significant increases in angina severity (Canadian Cardiovascular Society grade III/IV angina, 15.8% in 2010 and 38.4% in 2014), use of antianginal medications prior to PCI (at least 2 antianginal medications, 22.3% in 2010 and 35.1% in 2014), and high-risk findings on noninvasive testing (22.2% in 2010 and 33.2% in 2014) (P < .001 for all), but only modest increases in multivessel coronary artery disease (43.7% in 2010 and 47.5% in 2014, P < .001). The proportion of nonacute PCIs classified as inappropriate decreased from 26.2% (95% CI, 25.8%-26.6%) to 13.3% (95% CI, 13.1%-13.6%), and the absolute number of inappropriate PCIs decreased from 21 781 to 7921. Hospital-level variation in the proportion of PCIs classified as inappropriate persisted over the study period (median, 12.6% interquartile range, 5.9%-22.9% in 2014). CONCLUSIONS AND RELEVANCE: Since the publication of the Appropriate Use Criteria for Coronary Revascularization in 2009, there have been significant reductions in the volume of nonacute PCI. The proportion of nonacute PCIs classified as inappropriate has declined, although hospital-level variation in inappropriate PCI persists.
Abstract Cardiovascular disease (CVD) is a leading cause of death and disability in the United States. National quality programs such as the National Cardiovascular Data Registry (NCDR®) permit ...assessments of the quality of care and outcomes for broad populations of patients with CVD. This report provides data from 2014 from four NCDR® hospital quality programs: 1) CathPCI® for coronary angiography and percutaneous coronary intervention (667,424 procedures performed in 1,612 hospitals) ICD™ for implantable cardioverter defibrillators (158,649 procedures performed in 1,715 hospitals); 3) ACTION®-GWTG™ for acute coronary syndromes (182,903 patients admitted to 907 hospitals); and 4) IMPACT® for cardiac catheterization and intervention for pediatric and adult congenital heart disease (20,169 procedures in 76 hospitals). The report provides perspectives on the demographic and clinical characteristics of enrolled patients; characteristics of participating centers; selected measures of processes and outcomes of care.
CONTEXT Although the efficacy of carotid stenting has been established in clinical trials, outcomes of the procedure based on operator experience are less certain in clinical practice. OBJECTIVE To ...assess association between outcomes and 2 measures of operator experience: annual volume and experience at the time of the procedure among new operators who first performed carotid stenting after a national coverage decision by the Centers for Medicare & Medicaid Services (CMS). DESIGN, SETTING, AND PATIENTS Observational study using administrative data on fee-for-service Medicare beneficiaries aged 65 years or older undergoing carotid stenting between 2005 and 2007. MAIN OUTCOME MEASURE Thirty-day mortality stratified by very low, low, medium, and high annual operator volumes (<6, 6-11, 12-23, and ≥24 procedures per year, respectively) and treatment early vs late during a new operator's experience (1st to 11th procedure and 12th procedure or higher). RESULTS During the study period, 24 701 procedures were performed by 2339 operators. Of these, 11 846 were performed by 1792 new operators who first performed carotid stenting after the CMS national coverage decision. Overall, 30-day mortality was 1.9% (n = 461) and rate of failure to use an embolic protection device was 4.8% (n = 1173) . The median annual operator volume among Medicare beneficiaries was 3.0 per year (interquartile range, 1.4-6.5) and 11.6% of operators performed 12 or more procedures per year during the study period. Observed 30-day mortality was higher among patients treated by operators with lower annual volumes (2.5% 95% CI, 2.1%-2.9%, 1.9% 95% CI, 1.6%-2.3%, 1.6% 95% CI, 1.3%-1.9%, and 1.4% 95% CI, 1.1%-1.7% across the 4 categories; P < .001) and among patients treated early (2.3%; 95% CI, 2.0%-2.7%) vs late (1.4%; 95% CI, 1.1%-1.9%; P < .001) during a new operator's experience. After multivariable adjustment, patients treated by very low-volume operators had a higher risk of 30-day mortality compared with patients treated by high-volume operators (adjusted odds ratio, 1.9; 95% CI, 1.4-2.7; P < .001). Similarly, we found a higher risk of 30-day mortality in patients treated early vs late during a new operator's experience (adjusted odds ratio, 1.7; 95% CI, 1.2-2.4; P = .001). CONCLUSION Among older patients undergoing carotid stenting, lower annual operator volume and early experience are associated with increased 30-day mortality.
Standardization of risk is critical in benchmarking and quality improvement efforts for percutaneous coronary interventions (PCIs). In 2018, the CathPCI Registry was updated to include additional ...variables to better classify higher-risk patients.
This study sought to develop a model for predicting in-hospital mortality risk following PCI incorporating these additional variables.
Data from 706,263 PCIs performed between July 2018 and June 2019 at 1,608 sites were used to develop and validate a new full and pre-catheterization model to predict in-hospital mortality, and a simplified bedside risk score. The sample was randomly split into a development cohort (70%, n = 495,005) and a validation cohort (30%, n = 211,258). The authors created 1,000 bootstrapped samples of the development cohort and used stepwise selection logistic regression on each sample. The final model included variables that were selected in at least 70% of the bootstrapped samples and those identified a priori due to clinical relevance.
In-hospital mortality following PCI varied based on clinical presentation. Procedural urgency, cardiovascular instability, and level of consciousness after cardiac arrest were most predictive of in-hospital mortality. The full model performed well, with excellent discrimination (C-index: 0.943) in the validation cohort and good calibration across different clinical and procedural risk cohorts. The median hospital risk-standardized mortality rate was 1.9% and ranged from 1.1% to 3.3% (interquartile range: 1.7% to 2.1%).
The risk of mortality following PCI can be predicted in contemporary practice by incorporating variables that reflect clinical acuity. This model, which includes data previously not captured, is a valid instrument for risk stratification and for quality improvement efforts.
Display omitted
Little is known about national trends of pulmonary embolism (PE) hospitalizations and outcomes in older adults in the context of recent diagnostic and therapeutic advances. Therefore, we conducted a ...retrospective cohort study of 100% Medicare fee-for-service beneficiaries hospitalized from 1999 to 2010 with a principal discharge diagnosis code for PE. The adjusted PE hospitalization rate increased from 129/100,000 person-years in 1999 to 302/100,000 person-years in 2010, a relative increase of 134% (p <0.001). Black patients had the highest rate of increase (174 to 548/100,000 person-years) among all age, gender, and race categories. The mean (standard deviation) length of hospital stay decreased from 7.6 (5.7) days in 1999 to 5.8 (4.4) days in 2010, and the proportion of patients discharged to home decreased from 51.1% (95% confidence interval CI 50.5 to 51.6) to 44.1% (95% CI 43.7 to 44.6), whereas more patients were discharged with home health care and to skilled nursing facilities. The in-hospital mortality rate decreased from 8.3% (95% CI 8.0 to 8.6) in 1999 to 4.4% (95% CI 4.2 to 4.5) in 2010, as did adjusted 30-day (from 12.3% 95% CI 11.9 to 12.6 to 9.1% 95% CI 8.5 to 9.7) and 6-month mortality rates (from 23.0% 95% CI 22.5 to 23.4 to 19.6% 95% CI 18.8 to 20.5). There were no significant racial differences in mortality rates by 2010. There was no change in the adjusted 30-day all-cause readmission rate from 1999 to 2010. In conclusion, PE hospitalization rates increased substantially from 1999 to 2010, with a higher rate for black patients. All mortality rates decreased but remained high. The increase in hospitalization rates and continued high mortality and readmission rates confirm the significant burden of PE for older adults.
PDF
