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

Background: Percutaneous coronary intervention (PCI) for stable ischemic heart disease (SIHD) in older adults requires a meticulous assessment of procedural risks and benefits, but contemporary data on outcomes in this population is lacking. Therefore, we examined the risk of near-term readmission, bleeding, and mortality in high-risk cohort of older adults undergoing inpatient PCI for SIHD. METHODS: We analyzed the National Readmissions Database from 2017 to 2018 to identify index hospitalizations in which PCI was performed for SIHD. Patients were stratified into those ≥ 75 years old (older adults) and those < 75 years old. The primary outcome was 90-day readmission. Secondary outcomes included in-hospital mortality, hospital length of stay (LOS), and total hospital charge. RESULTS: A total of 74,516 patients underwent inpatient PCI for SIHD, of whom 24,075 were older adults. Older adult patients had higher odds of in-hospital mortality (OR = 2.00, 95% CI: 1.68-2.38), intracranial hemorrhage (OR = 2.03, 95% CI: 1.24-3.34), and gastrointestinal hemorrhage (OR = 1.72, 95% CI: 1.43-2.07) during index hospitalization, with longer LOS and in-hospital charge. Older adults also experienced a higher hazard of 90-day readmission for any cause (HR = 1.61, 95% CI: 1.57-1.66) and cardiovascular causes (HR = 1.84, 95% CI: 1.77-1.91). CONCLUSION: Older adults undergoing inpatient PCI for SIHD were at increased risk for in-hospital mortality, periprocedural morbidities, higher cost, and readmissions compared with younger adults. Understanding these differences may improve shared decision-making for patients with SIHD being considered for PCI. [ABSTRACT FROM AUTHOR]

Importance: The US Department of Justice (DOJ) conducted an investigation into implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria.Objective: To examine changes in the proportion of initial primary prevention ICDs that did not meet NCD criteria following the announcement of the DOJ investigation at hospitals that reached settlements (settlement hospitals) and those that did not (nonsettlement hospitals).Design, Setting, and Participants: Multicenter, longitudinal, serial cross-sectional analysis of 300 151 initial primary prevention ICDs among Medicare beneficiaries from January 1, 2007, through December 31, 2015, at 1809 US hospitals in the National Cardiovascular Data Registry (NCDR) ICD Registry, of which 452 hospitals (with 99 591 primary prevention ICDs) reached settlements with the DOJ.Exposures: The DOJ investigation announcement in 2010.Main Outcomes and Measures: Proportion of initial primary prevention ICDs not meeting NCD criteria.Results: In January 2007, the proportion of initial ICDs not meeting NCD criteria was 25.8% (95% CI, 24.7% to 26.8%) at settlement hospitals and 22.8% (95% CI, 22.1% to 23.5%) at nonsettlement hospitals (P < .001). Over the study period, there was a 62.7% (95% CI, 59.2% to 66.1%) relative decrease and 16.1% (95% CI, 14.8% to 17.5%) absolute decrease in the proportion of ICDs not meeting NCD criteria at settlement hospitals compared with a 53.2% (95% CI, 50.4% to 56.0%) relative decrease and 12.1% (95% CI, 11.2% to 13.0%) absolute decrease in proportion at nonsettlement hospitals (P < .001 for both; P for interaction < .001). Trends significantly differed between hospital groups only in the period following the announcement of the DOJ investigation (January 2010-June 2011) [corrected], with larger and more rapid decreases at settlement hospitals (P for interaction = .01). Over the study period, there was a 32.8% (95% CI, 29.9% to 35.7%) relative decrease and a 1703 ICDs (95% CI, 1520 to 1886) absolute decrease in the volume of primary prevention ICDs implanted at settlement hospitals compared with a 17.4% (95% CI, 14.8% to 20.0%) relative decrease and a 1495 ICDs (95% CI, 1249 to 1741) absolute decrease in volume at nonsettlement hospitals (P < .001 for both; P for interaction < .001), with more modest decreases or slight increases in secondary prevention ICD volume. These patterns were similar when examining ICD utilization among non-Medicare beneficiaries.Conclusions and Relevance: From 2007 through 2015, the volume of primary prevention implantable cardioverter-defibrillators and the proportion of devices not meeting the Centers for Medicare & Medicaid Services National Coverage Determination criteria decreased at all hospitals with substantially larger decreases at hospitals that reached settlements in the US Department of Justice investigation. These patterns extended to implantable cardioverter-defibrillators placed in non-Medicare beneficiaries, which were not the focus of the US Department of Justice investigation. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Publicly reported hospital risk-standardized mortality rates (RSMRs) for acute myocardial infarction (AMI) are calculated for Medicare beneficiaries. Outcomes for older patients with AMI may not reflect general outcomes.Objective: To examine the relationship between hospital 30-day RSMRs for older patients (aged ≥65 years) and those for younger patients (aged 18 to 64 years) and all patients (aged ≥18 years) with AMI.Design: Retrospective cohort study.Setting: 986 hospitals in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-Get With the Guidelines.Participants: Adults hospitalized for AMI from 1 October 2010 to 30 September 2014.Measurements: Hospital 30-day RSMRs were calculated for older, younger, and all patients using an electronic health record measure of AMI mortality endorsed by the National Quality Forum. Hospitals were ranked by their 30-day RSMRs for these 3 age groups, and agreement in rankings was plotted. The correlation in hospital AMI achievement scores for each age group was also calculated using the Hospital Value-Based Purchasing (HVBP) Program method computed with the electronic health record measure.Results: 267 763 and 276 031 AMI hospitalizations among older and younger patients, respectively, were identified. Median hospital 30-day RSMRs were 9.4%, 3.0%, and 6.2% for older, younger, and all patients, respectively. Most top- and bottom-performing hospitals for older patients were neither top nor bottom performers for younger patients. In contrast, most top and bottom performers for older patients were also top and bottom performers for all patients. Similarly, HVBP achievement scores for older patients correlated weakly with those for younger patients (R = 0.30) and strongly with those for all patients (R = 0.92).Limitation: Minority of U.S. hospitals.Conclusion: Hospital mortality rankings for older patients with AMI inconsistently reflect rankings for younger patients. Incorporation of younger patients into assessment of hospital outcomes would permit further examination of the presence and effect of age-related quality differences.Primary Funding Source: American College of Cardiology. [ABSTRACT FROM AUTHOR]

Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States.Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events.Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA2DS2-VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P=0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication.Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events. [ABSTRACT FROM AUTHOR]

Background: Substantial geographic variation exists in percutaneous coronary intervention (PCI) use across the United States. It is unclear the extent to which high PCI utilization can be explained by PCI for inappropriate indications. The objective of this study was to examine the relationship between PCI rates across regional healthcare markets utilizing hospital referral regions (HRRs) and PCI appropriateness. Methods: The number of PCI procedures in each HRR was obtained from the 2010 100% Medicare limited data set. HRRs were divided into quintiles of PCI utilization with increasing rates of utilization progressing to quintile 5. NCDR CathPCI Registry® data were used to evaluate patient characteristics, appropriate use criteria (AUC), and outcomes across the HRR quintiles defined by PCI utilization with the study population restricted to HRRs where ≥ 80% of the PCIs were performed at institutions participating in the registry. PCI appropriateness was defined using 2012 AUC by the American College of Cardiology (ACC)/American Heart Association (AHA)/The Society for Cardiovascular Angiography and Interventions (SCAI). Results: Our study cohort comprised of 380,981 patients treated at 178 HRRs. Mean PCI rates per 1,000 increased from 4.6 in Quintile 1 to 10.8 in Quintile 5. The proportion of non-acute PCIs was 27.7% in Quintile 1 increasing to 30.7% in Quintile 5. Significant variation (p < 0.001) existed across the quintiles in the categorization of appropriateness across HRRs of utilization with more appropriate PCI in lower utilization areas (Appropriate: Q1, 76.53%, Q2, 75.326%, Q3, 75.23%, Q4, 73.95%, Q5, 72.768%; Inappropriate: Q1 3.92%, Q2 4.23%, Q3 4.32%, Q4 4.35%, Q5 4.05%; Uncertain: Q1 8.29%, Q2 8.84%, Q3 8.08%, Q4 9.01%, Q5 8.93%; Not Mappable: Q1 11.26%, Q2 11.67%, Q3 12.37%, Q4 12.69%, Q5 14.34%). There was no difference in risk-adjusted mortality across quintiles of PCI utilization. Conclusions: Geographic regions with lower PCI rates have a higher proportion of PCIs performed for appropriate indications. Areas that perform more PCIs also appear to perform more elective PCI and many could not be mapped by the AUC. [ABSTRACT FROM AUTHOR]

Background Advances in implantable cardioverter defibrillator (ICD) technology have resulted in more effective defibrillation, and the need for defibrillation threshold (DFT) testing has been questioned. Methods A total of 64,227 initial ICD implant procedures performed at 1,261 facilities (April to December 2010) in the NCDR Registry™ were selected to identify patterns of practice related to DFT testing. Patient, physician, and procedural characteristics were compared. Independent association of DFT testing with in-hospital adverse events or mortality was also examined. Results DFT testing was performed in 71% of patients. Patients who did not undergo testing were older; more often had heart failure, lower left ventricular ejection fraction, atrial arrhythmias, and a primary prevention indication; and were more likely to receive a cardiac resynchronization therapy device. In addition, patients who did not undergo testing were less likely to be implanted in a metropolitan area and more often implanted at a teaching hospital, in New England, in the Mid-Atlantic, or in the Pacific U.S . In-hospital adverse events occurred in 2.56% of patients who underwent DFT testing compared to 3.58% who did not (P < 0.001). Death or any complication remained more likely to occur in patients who did not undergo testing (odds ratio and 95% confidence interval: 1.46 [1.33, 1.61], P < 0.001), after adjusting for baseline and procedural differences. Conclusions DFT testing is not performed in many (29%) patients in clinical practice. Patients who did not undergo testing were more likely to have adverse events and to be older with more comorbidities, which could explain why DFT testing was avoided. Prospective randomized data are needed to determine the impact of DFT testing on outcome. [ABSTRACT FROM AUTHOR]

Background: Despite recent improvements in survival after acute myocardial infarction (AMI), U.S. hospitals vary 2-fold in their 30- day risk-standardized mortality rates (RSMRs). Nevertheless, information is limited on hospital-level factors that may be associated with RSMRs. Objective: To identify hospital strategies that were associated with lower RSMRs. Design: Cross-sectional survey of 537 hospitals (91% response rate) and weighted multivariate regression by using data from the Centers for Medicare & Medicaid Services to determine the associations between hospital strategies and hospital RSMRs. Setting: Acute care hospitals with an annualized AMI volume of at least 25 patients. Participants: Patients hospitalized with AMI between 1 January 2008 and 31 December 2009. Measurements: Hospital performance improvement strategies, characteristics, and 30-day RSMRs. Results: In multivariate analysis, several hospital strategies were significantly associated with lower RSMRs and in aggregate were associated with clinically important differences in RSMRs. These strategies included holding monthly meetings to review AMI cases between hospital clinicians and staff who transported patients to the hospital (RSMR lower by 0.70 percentage points), having cardiologists always on site (lower by 0.54 percentage points), fostering an organizational environment in which clinicians are encouraged to solve problems creatively (lower by 0.84 percentage points), not cross-training nurses from intensive care units for the cardiac catheterization laboratory (lower by 0.44 percentage points), and having physician and nurse champions rather than nurse champions alone (lower by 0.88 percentage points). Fewer than 10% of hospitals reported using at least 4 of these 5 strategies. Limitation: The cross-sectional design demonstrates statistical associations but cannot establish causal relationships. Conclusion: Several strategies, which are currently implemented by relatively few hospitals, are associated with significantly lower 30- day RSMRs for patients with AMI. Primary Funding Source: The Agency for Healthcare Research and Quality, the United Health Foundation, and the Commonwealth Fund. [ABSTRACT FROM AUTHOR]

The article discusses a study on outcomes of carotid stenting based on operator experience in the U.S. from 2005 to 2007. The study evaluated the link between outcomes and two variables of operator experience, namely, annual volume and experience at the time of the procedure among new operators who performed carotid stenting for the first time following a national coverage decision by the Centers for Medicare & Medicaid Services (CMS). Administrative data collected from fee-for-service Medicare beneficiaries aged 65 years old and above was used under the study. Higher 30-day mortality was observed among patients treated by operators with lower annual volumes and patients treated early during a new operator's experience.

The article discusses as study which examined regional variations in the utilization of primary prevention implantable cardioverter-defibrillators (ICD) for the primary prevention of sudden cardiac death in the U.S. Results showed substantial variation across quantiles of rate ratios of ICD implantation, ranging from 0.39 to 1.77. In addition, 13% of patients receiving ICDs did not meet trial criteria. It concluded that marked geographic variation in the use of primary prevention ICDs exists which is not correlated with physician supply.

The article discusses a study which described the temporal changes in length of stay, discharge disposition, and short-term outcomes among older U.S. patients hospitalized for heart failure. The observational study examined 6,955,461 Medicare fee-for-service hospitalizations for heart failure between 1993 and 2006. The researchers found that the mean length of stay decreased from 8.81 days to 6.33 days between 1993 and 2006. The importance of examining an episode of acute care during a standardized period of assessment is also highlighted by the study.

The article presents a study which investigates the survival impact of regionalization of acute myocardial infarction (AMI) care on percutaneous coronary intervention (PCI) hospitals in the U.S. Risk-standardized mortality rates (RSMRs) between PCI hospitals and non-PCI hospitals within the same health care regions were analyzed. The study suggests that regionalizing AMI care to PCI hospitals can reduce mortality rates, however, survival outcomes varies across the regions.

The article focuses on an observational study which estimated hospital-level 30-day risk-standardized mortality rates (RSMRs) for patients discharged with acute myocardial infarction (AMI). Administrative data and a validated risk model were used to evaluate 3,195,672 discharges in 2,755,370 patients discharged from nonfederal acute care hospitals in the U.S. between January 1, 1995 to December 31, 2006. A significant decrease was observed in the risk-standardized hospital mortality rate for Medicare patients discharged with AMI, as well as between-hospital variation.

The article comments on efforts to report patient outcomes using Medicare claims data from the United States Centers for Medicare and Medicaid Services. The data was used to determine the postprocedure complication and mortality rates in patients who were implanted with cardioverter defibrillators. There were specific factors associated with chronic lung disease, dementia and renal disease.

We used data from 1,344 patients enrolled in the Prospective Registry Evaluating Myocardial Infarction: Events and Recovery study to examine the adoption of drug-eluting stents (DESs) and the effect of the release of the Food and Drug Administration’s preliminary public health notification, which raised concerns about DES safety. Overall, there was a dramatic increase in the use of DESs over the study period, from 32% in April 2003 to 81% in March 2004. The notification issued on October 29, 2003 was associated with a 26% relative decrease in DES use. By January 2004, DES use had returned to the prenotification rate and continued to increase thereafter. In conclusion, the Food and Drug Administration’s notification had a modest but temporary effect on clinical practice. [Copyright &y& Elsevier]

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 levels: time 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 death: odds ratio, 1.24 (95% CI, 1.13-1.36); bleeding: odds ratio, 1.10 (95% CI, 1.00-1.21); and stroke: odds ratio, 1.34 (95% CI, 1.18-1.53), although a similar, nonsignificant result was observed for acute kidney injury: odds 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. [ABSTRACT FROM AUTHOR]

Discusses whether prescribing aspirin and ibuprofen to patients being discharged after myocardial infarction is associated with an increased risk of death. Use of the database compiled by the Cooperative Cardiovascular Project in the United States; Number of Medicare patients in the study; Finding that the two drugs did not interact adversely; Possible bias in this research; Limitations of another study that concluded patients who received combined therapy were at an increased risk of death.

Background: Patients with moderate-to-severe chronic kidney disease (CKD) are poorly represented in clinical trials of cardiac resynchronization therapy (CRT).Objectives: This study sought to assess the real-world comparative effectiveness of CRT with defibrillator (CRT-D) versus implantable cardioverter-defibrillator (ICD) alone in CRT-eligible patients with moderate-to-severe CKD.Methods: We conducted an inverse probability-weighted analysis of 10,946 CRT-eligible patients (ejection fraction <35%, QRS >120 ms, New York Heart Association functional class III/IV) with stage 3 to 5 CKD in the National Cardiovascular Data Registry (NCDR) ICD Registry, comparing outcomes between patients who received CRT-D (n = 9,525) versus ICD only (n = 1,421). Outcomes were obtained via Medicare claims and censored at 3 years. The primary endpoint of heart failure (HF) hospitalization or death and the secondary endpoint of death were assessed with Cox proportional hazards models. HF hospitalization, device explant, and progression to end-stage renal disease were assessed using Fine-Gray models.Results: After risk adjustment, CRT-D use was associated with a reduction in HF hospitalization or death (hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.78 to 0.91; p < 0.0001), death (HR: 0.85; 95% CI: 0.77 to 0.93; p < 0.0004), and HF hospitalization alone (subdistribution HR: 0.84; 95% CI: 0.76 to 0.93; p < 0.009). Subgroup analyses suggested that CRT was associated with a reduced risk of HF hospitalization and death across CKD classes. The incidence of in-hospital, short-term, and mid-term device-related complications did not vary across CKD stages.Conclusions: In a nationally representative population of HF and CRT-eligible patients, use of CRT-D was associated with a significantly lower risk of the composite endpoint of HF hospitalization or death among patients with moderate-to-severe CKD in the setting of acceptable complication rates. [ABSTRACT FROM AUTHOR]

Background: 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.Objectives: This study sought to develop a model for predicting in-hospital mortality risk following PCI incorporating these additional variables.Methods: 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.Results: 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%).Conclusions: 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. [ABSTRACT FROM AUTHOR]

Background: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.Objectives: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.Methods: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.Results: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean 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.Conclusions: The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials. [ABSTRACT FROM AUTHOR]

Keywords: administrative claims, healthcare; clinical trial; coronary artery disease EN administrative claims, healthcare clinical trial coronary artery disease 306 308 3 07/23/20 20200721 NES 200721 B Editorial, see p 214 b Using administrative claims data to ascertain clinical events may be a pragmatic way to make randomized, controlled trials cheaper and more efficient. However, little is known about the accuracy of claims data for estimating treatment effects of randomized therapies. [Extracted from the article]

Background: Risk standardization for adverse events after congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR's (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment).Methods: Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%.Results: The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination, with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent, with a slope of 0.97 (standard error, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95).Conclusions: The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Public reporting has been proposed as a strategy to improve health care quality. Percutaneous coronary interventions (PCIs) performed in the United States from July 1, 2009, to June 30, 2011, included in the CathPCI Registry were identified (n = 1,340,213). Patient characteristics and predicted and observed in-hospital mortality were compared between patients treated with PCI in states with mandated public reporting (Massachusetts, New York, Pennsylvania) and states without mandated public reporting. Most PCIs occurred in states without mandatory public reporting (88%, n = 1,184,544). Relative to patients treated in nonpublic reporting states, those who underwent PCI in public reporting states had similar predicted in-hospital mortality (1.39% vs 1.37%, p = 0.17) but lower observed in-hospital mortality (1.19% vs 1.41%, adjusted odds ratio [ORadj] 0.80; 95% confidence interval [CI] 0.74, 0.88; p <0.001). In patients for whom outcomes were available at 180 days, the differences in mortality persisted (4.6% vs 5.4%, ORadj 0.85, 95% CI 0.79 to 0.92, p <0.001), whereas there was no difference in myocardial infarction (ORadj0.97,95% CI 0.89 to 1.07) or revascularization (ORadj1.05,95% CI 0.92 to 1.20). Hospital readmissions were increased at 180 days in patients who underwent PCI in public reporting states (ORadj 1.08,95% CI 1.03 to 1.12, p = 0.001). In conclusion, patients who underwent PCI in states with mandated public reporting of outcomes had similar predicted risks but significantly lower observed risks of death during hospitalization and in the 6 months after PCI. These findings support considering public reporting as a potential strategy for improving outcomes of patients who underwent PCI although further studies are warranted to delineate the reasons for these differences. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this report was to characterize the patients, participating centers, and measures of quality of care and outcomes for 5 NCDR (National Cardiovascular Data Registry) programs: 1) ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry–GWTG (Get With The Guidelines) for acute coronary syndromes; 2) CathPCI Registry for coronary angiography and percutaneous coronary intervention; 3) CARE (Carotid Artery Revascularization and Endarterectomy) Registry for carotid revascularization; 4) ICD Registry for implantable cardioverter defibrillators; and the 5) PINNACLE (Practice INNovation And CLinical Excellence) Registry for outpatients with cardiovascular disease (CVD). Background: CVD is a leading cause of death and disability in the United States. The quality of care for patients with CVD is suboptimal. National registry programs, such as NCDR, permit assessments of the quality of care and outcomes for broad populations of patients with CVD. Methods: For the year 2011, we assessed for each of the 5 NCDR programs: 1) demographic and clinical characteristics of enrolled patients; 2) key characteristics of participating centers; 3) measures of processes of care; and 4) patient outcomes. For selected variables, we assessed trends over time. Results: In 2011 ACTION Registry–GWTG enrolled 119,967 patients in 567 hospitals; CathPCI enrolled 632,557 patients in 1,337 hospitals; CARE enrolled 4,934 patients in 130 hospitals; ICD enrolled 139,991 patients in 1,435 hospitals; and PINNACLE enrolled 249,198 patients (1,436,328 individual encounters) in 74 practices (1,222 individual providers). Data on performance metrics and outcomes, in some cases risk-adjusted with validated NCDR models, are presented. Conclusions: The NCDR provides a unique opportunity to understand the characteristics of large populations of patients with CVD, the centers that provide their care, quality of care provided, and important patient outcomes. [Copyright &y& Elsevier]

Objectives: This study sought to assess percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) stenosis in routine U.S. clinical practice. Background: Percutaneous coronary intervention for ULMCA stenosis is controversial; however, current use and outcomes of ULMCA PCI in routine U.S. clinical practice have not been described. Methods: We evaluated 5,627 patients undergoing ULMCA PCI at 693 centers within the National Cardiovascular Data Registry Catheterization Percutaneous Coronary Intervention Registry for temporal trends in PCI use (2004 to 2008), patient characteristics, and in-hospital mortality. Thirty-month mortality and composite major adverse events (death, myocardial infarction, and revascularization) with drug-eluting versus bare-metal stents were compared using inverse probability weighted (IPW) hazard ratios (HRs) in a nonrandomized Medicare-linked (age ≥65 years) patient cohort (n = 2,765). Results: ULMCA PCI was performed in 4.3% of patients with ULMCA stenosis. Unadjusted in-hospital mortality rates ranged from 2.9% for elective cases to 45.1% for emergent/salvage cases. By 30 months, 57.9% of the elderly ULMCA PCI population experienced death, myocardial infarction, or revascularization, and 42.7% died. Patients receiving drug-eluting stents (versus bare-metal stents) had a lower 30-month mortality (IPW HR: 0.84, 95% confidence interval [CI]: 0.73 to 0.96), but the composite of major adverse events were similar (IPW HR: 0.95, 95% CI: 0.84 to 1.06). Conclusions: In the United States, ULMCA PCI is performed in <5% of patients with ULMCA disease and is generally reserved for those at high procedural risk. Adverse events are common in elderly patients and are related to patient and procedural characteristics, including stent type. [ABSTRACT FROM AUTHOR]

Use of peripheral vascular intervention (PVI) for intermittent claudication (IC) continues to expand, but there is uncertainty whether baseline demographics, procedural techniques and outcomes differ by sex, race, and ethnicity. This study aimed to examine amputation and revascularization rates up to 4 years after femoropopliteal (FP) PVI for IC by sex, race, and ethnicity. Patients who underwent FP PVI for IC between 2016 and 2020 from the PINC AI Healthcare Database were analyzed. The primary outcome was any index limb amputation, assessed by Kaplan-Meier estimate. Secondary outcomes included index limb major amputation, repeat revascularization, and index limb repeat revascularization. Unadjusted and adjusted hazard ratios (HRs) were estimated using Cox proportional hazard regression models. This study included 19,324 patients with IC who underwent FP PVI, with 41.2% women, 15.6% Black patients, and 4.7% Hispanic patients. Women were less likely than men to be treated with atherectomy (45.1% vs 47.8%, p = 0.0003); Black patients were more likely than White patients to receive atherectomy (50.7% vs 44.9%, p <0.001), and Hispanic patients were less likely than non-Hispanic patients to receive atherectomy (41% vs 47%, p = 0.0004). Unadjusted rates of any amputation were similar in men and women (6.4% for each group, log-rank p = 0.842), higher in Black patients than in White patients (7.8% vs 6.1%, log-rank p = 0.007), and higher in Hispanic patients than in non-Hispanic patients (8.8% vs 6.3%, log-rank p = 0.031). After adjustment for baseline characteristics, Black race was associated with higher rates of repeat revascularization (adjusted HR 1.13, 95% confidence interval 1.04 to 1.22) and any FP revascularization (adjusted HR 1.10, 95% confidence interval 1.01 to 1.20). No statistical difference in amputation rate was observed among comparison groups. Women and men with IC had similar crude and adjusted amputation and revascularization outcomes after FP PVI. Black patients had higher repeat revascularization and any FP revascularization rates than did White patients. Black and Hispanic patients had higher crude amputation rates, but these differences were attenuated by adjustment for baseline characteristics. Black patients were more likely to receive atherectomy and had higher rates of any repeat revascularization and specifically FP revascularization. Further study is necessary to determine whether these patterns are related to disease-specific issues or practice-pattern differences among different populations., Competing Interests: Declaration of competing interest Dr. Hess has received research funding to CPC Clinical Research from Merck, Bayer, and Amgen. Dr. Julien discloses equity in Johnson and Johnson and Shockwave Medical. Dr. Curtis has a contract with the American College of Cardiology for his role as Chief Scientific Advisor, National Cardiovascular Data Registry; and holds equity interest in Medtronic. The remaining authors have no competing interests to declare., (Copyright © 2024. Published by Elsevier Inc.)

The practice patterns and outcomes of protected left main (PLM) and unprotected left main (ULM) percutaneous coronary intervention (PCI) are not well defined in contemporary US clinical practice. Data were collected from all Veteran Affairs catheterization laboratories participating in the Clinical Assessment Reporting and Tracking Program between 2009 and 2019. The analysis included 4,351 patients who underwent left main PCI, of whom 1,306 pairs of PLM and ULM PCI were included in a propensity-matched cohort. Selected temporal trends were also assessed. The primary outcome was major adverse cardiovascular event (MACE) outcomes at 1 year, which was defined as a composite of all-cause mortality, rehospitalization for myocardial infarction (MI), rehospitalization for stroke, or urgent revascularization. Patients who underwent ULM PCI compared with patients who underwent PLM PCI were older (age 71.5 vs 69.2 years, p <0.001), more clinically complex, and more likely to present with acute coronary syndrome. In the propensity-matched cohort, radial access was used more often for ULM PCI (21% [273] vs 14% [185], p <0.001) and ULM PCI was more likely to involve the left main bifurcation (22% vs 14%, p = 0.003) and require mechanical circulatory support (10% [134] vs 1% [17], p <0.001). The 1-year MACEs occurred more frequently with ULM PCI than PLM PCI (22% [289] vs 16% [215], p ≤0.001) and all-cause mortality was also higher (16% [213] vs 10% [125], p ≤0.001). In the matched cohort, there was a low incidence of rehospitalization for MI (4% [48] ULM vs 4% [48] PLM, p = 1.000) or revascularization (7% [94] ULM vs 6% [84] PLM, p = 0.485). In this real-world experience, patients who underwent PLM PCI had better 1-year outcomes than those who underwent ULM PCI; however, in both groups, there was a high rate of mortality and MACEs at 1 year despite a relatively low rate of MI or revascularization., Competing Interests: Declaration of competing interest Dr. Shah receives investigator-initiated research support from Abbott Vascular and the Food and Drug Administration. Dr. Waldo has received investigator-initiated research support from Abiomed, Cardiovascular Systems Incorporated, Janssen Pharmaceuticals, National Institutes of Health, and VA Health Services Research & Development. Dr. Curtis receives salary support from the American College of Cardiology for his role as Chief Scientific Advisor of the National Cardiovascular Data Registry. Dr Curtis has equity interest in Medtronic, a maker of cardiac stents. The remaining authors have no competing interests to declare., (Published by Elsevier Inc.)

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

Background Frailty is rarely assessed in clinical trials of patients who receive dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. This study investigated whether frailty defined using claims data is associated with outcomes following percutaneous coronary intervention, and if there is a differential association in patients receiving standard versus extended duration DAPT. Methods and Results Patients ≥65 years of age in the DAPT (Dual Antiplatelet Therapy) Study, a randomized trial comparing 30 versus 12 months of DAPT following percutaneous coronary intervention, had data linked to Medicare claims (n=1326), and a previously validated claims-based index was used to define frailty. Net adverse clinical events, a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding, were compared between frail and nonfrail patients. Patients defined as frail using claims data (12.0% of the cohort) had higher incidence of net adverse clinical events (23.1%) compared with nonfrail patients (10.7%; P <0.001) at 18-month follow-up and increased risk after multivariable adjustment (adjusted hazard ratio [HR], 2.24 [95% CI, 1.38-3.63]). There were no differences in effects of extended duration DAPT on net adverse clinical events for frail (HR, 1.42 [95% CI, 0.73-2.75]) and nonfrail patients (HR, 1.18 [95% CI, 0.83-1.68]; interaction P =0.61), although analyses were underpowered. Bleeding was highest among frail patients who received extended duration DAPT. Conclusions Among older patients in the DAPT Study, claims-defined frailty was associated with higher net adverse clinical events. Effects of extended duration DAPT were not different for frail patients, although comparisons were underpowered. Further investigation of how frailty influences ischemic and bleeding risks with DAPT are warranted. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00977938.

Background: Despite strong guideline recommendations for cardiac resynchronization therapy-defibrillator (CRT-D) in select patients, this therapy is underutilized with substantial variation among hospitals, and the association of this variation with outcomes is unknown., Objective: The purpose of this study was to assess whether facility variation in CRT-D utilization is associated with differences in hospital-level outcomes., Methods: We linked Medicare claims data with the National Cardiovascular Data Registry's ICD Registry from 2010 to 2015. We calculated the intraclass correlation coefficient to quantify the degree of variation in patient-level CRT use that can be explained by interfacility variation on a hospital level. To quantify the degree of hospital variation in patient-level outcomes (all-cause mortality, readmissions, and cardiac readmissions) that can be attributed to variations in CRT-D use, we utilized multilevel modeling., Results: The study included 30,134 patients across 1377 hospitals. The median rate of CRT-D implantation in those meeting guideline indications was 89%, but there was a wide variation across hospitals. After adjustment, most of the variation (74%) in hospital rates of CRT-D utilization was attributable to the hospital in which the patient was treated. Differences in hospital CRT-D utilization was associated with 8.76%, 5.26%, and 4.71% of differences in hospital mortality, readmissions, and cardiac readmission rates, respectively (P < .001 for all outcomes)., Conclusion: There is a wide variation in the use of CRT-D across hospitals that was not explained by case mix. Hospital-level variation in CRT-D utilization was associated with clinically significant differences in outcomes. A measure of CRT-D utilization in eligible patients may serve as a useful metric for quality improvement efforts., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: We assess the rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the American College of Cardiology National Cardiovascular Data Registry-Peripheral Vascular Intervention (PVI) registry., Methods: Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index score for patients' zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Centers for Medicare and Medicaid Services data, we compared 1-year mortality, rates of amputation, and repeat revascularizations., Results: Of 63 150 study cases, 55 719 (88.2%) were performed in White patients and 7431 (11.8%) in Black patients. Black patients were younger (67.9 versus 70.0 years), had higher rates of hypertension (94.4% versus 89.5%), diabetes (63.0% versus 46.2%), less likely to be able to walk 200 m (29.1% versus 24.8%), and higher Distressed Community Index scores (65.1 versus 50.6). Black patients were provided drug-eluting technologies at a higher rate (adjusted odds ratio, 1.14 [95% CI, 1.06-1.23]) with no difference in atherectomy (adjusted odds ratio, 0.98 [95% CI, 0.91-1.05]) or intravascular imaging (adjusted odds ratio, 1.03 [95% CI, 0.88-1.22]) use. Black patients experienced a lower rate of acute kidney injury (adjusted odds ratio, 0.79 [95% CI, 0.72-0.88]). In Centers for Medicare and Medicaid Services-linked analyses of 7429 cases (11.8%), Black patients were significantly less likely to have surgical (adjusted hazard ratio, 0.40 [95% CI, 0.17-0.96]) or repeat PVI revascularization (adjusted hazard ratio, 0.42 [95% CI, 0.30-0.59]) at 1 year compared with White patients. There was no difference in mortality (adjusted hazard ratio [0.8-1.4]) or major amputation (adjusted hazard ratio, 2.5 [95% CI, 0.8-7.6]) between Black and White patients., Conclusions: Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure., Competing Interests: Disclosures Dr Julien discloses equity in Johnson and Johnson and Shockwave Medical stock. Dr Curtis has an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the National Cardiovascular Data Registry; has received salary support from the American College of Cardiology and Centers for Medicaid & Medicare Services; and has equity in Medtronic. Dr Fanaroff has reports a career development award from the American Heart Association, research funding to his institution from Boston Scientific, and consulting fees from the American Heart Association. Dr Khatana has received grant support from under National Heart, Lung, and Blood Institute (5K23 HL153772-02) and the American Heart Association (20CDA35320251). Dr Secemsky has Research grants to Beth Israel Deaconess Medical Center: NIH/National Heart Lung and Blood Institute K23HL150290, Harvard Medical School’s Shore Faculty Development Award, AstraZeneca, Becton Dickinson, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic and Philips. Consulting/Speaking: Abbott, Asahi, Bayer, BD, Boston Scientific, Cook, Cardiovascular Systems Incorporated, Inari, Janssen, Medtronic, Philips, and VentureMed. Dr Vora has received education and research funding from Medtronic. Dr Armstrong has consulted for Abbott Vascular, Boston Scientific, Cardiovascular Systems, Medtronic, and Spectranetics. Dr Jaff is employed on a part time basis by Boston Scientific and shareholder of Boston Scientific Corporation. Dr Giri has served on advisory boards for Astra Zeneca, Philips Medical, Boston Scientific and Inari Medical, and received research funds to the institution from St. Jude Medical, Boston Scientific, Inari Medical, and Recor Medical. The other authors report no conflicts.

Objectives: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States., Background: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported., Methods: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates., Results: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA 2 DS 2 -VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure., Conclusions: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy., Competing Interests: Funding Support and Author Disclosures This study was funded by the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute (grants R56HL142765 and R01HL142765). Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Boston Scientific; has received consulting honoraria from W.L. Gore, Baylis Medical, Philips, Biotronik, Biosense Webster, and Shockwave; has received consulting honoraria and speaker fees from Medtronic; and has equity interest in Indian Wells. Dr Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; and has received consulting and advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster. Dr Rammohan has received consulting fees from Medtronic and Abbott Vascular. Dr Turi has received honoraria from Coherex for serving on the clinical events committee for the WAVECREST 2 (Wavecrest vs. Watchman Transseptal LAA Closure to Reduce AF-Mediated Stroke 2) trial. Dr Varosy has received salary support from the National Heart, Lung, and Blood Institute. Dr Curtis has an institutional contract with the American College of Cardiology for his role as senior scientific adviser of the NCDR; has received salary support from the American College of Cardiology and CMS; and has equity in Medtronic. Dr Masoudi has had an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Background: The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking., Objectives: The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD., Methods: The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models., Results: A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161)., Conclusions: In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients., Competing Interests: Funding Support and Author Disclosures This research was supported by the American College of Cardiology’s National Cardiovascular Data Registry (NCDR). The views expressed in this paper represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at CVQuality.ACC.org/NCDR. The ICD Registry is an initiative of the American College of Cardiology with partnering support from the Heart Rhythm Society. Dr Heist has received consulting fees from Abbott, Boston Scientific, Medtronic, and Pfizer; has received research grants from Abbott, Biotronik, and Pfizer; and has received honoraria from Medtronic, Biotronik, and Abbott. Dr Russo has received research support from Boston Scientific and Medilynx; and serves on research steering committees for Apple and Boston Scientific (no honoraria). Dr Ranasinghe has received research grants from the National Heart Foundation and the National Health and Medical Research Council of Australia. Dr Zeitler has received consulting fees from Medtronic Inc; and has received research grants from Boston Scientific and the NCDR. Dr Minges has received salary support from the American College of Cardiology for analytic services performed. Dr Freeman has received salary support from the American College of Cardiology, NCDR, and the National Heart, Lung, and Blood Institute; has received consulting/advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Pacemate, and Biosense Webster; has equity in Pacemate; has received research grants from the American Heart Association, NCDR, Boston Scientific, Abbott, Medtronic, Merit Medical, and Biosense Webster; and has received consulting fees from Abbott and AtriCure. Dr Curtis has received an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the NCDR; and has equity interest in Medtronic. Dr Al-Khatib has received research fees from Medtronic, Boston Scientific, and Abbott; and has received speaker fees from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Importance: Limited data exist regarding the characteristics of hospitals that do and do not participate in voluntary public reporting programs., Objective: To describe hospital characteristics and trends associated with early participation in the American College of Cardiology (ACC) voluntary reporting program for cardiac catheterization-percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries., Design, Setting, and Participants: This cross-sectional study analyzed enrollment trends and characteristics of hospitals that did and did not participate in the ACC voluntary public reporting program. All hospitals reporting procedure data to the National Cardiovascular Data Registry (NCDR) CathPCI or ICD registries that were eligible for the public reporting program from July 2014 (ie, program launch date) to May 2017 were included. Stepwise logistic regression was used to identify hospital characteristics associated with voluntary participation. Enrollment trends were evaluated considering the date US News & World Report (USNWR) announced that it would credit participating hospitals. Data analysis was performed from March 2017 to January 2018., Main Outcomes and Measures: Hospital characteristics and participation in the public reporting program., Results: By May 2017, 561 of 1747 eligible hospitals (32.1%) had opted to participate in the program. Enrollment increased from 240 to 376 hospitals (56.7%) 1 month after the USNWR announcement that program participation would be considered as a component of national hospital rankings. Compared with hospitals that did not enroll, program participants had increased median (IQR) procedural volumes for PCI (481 [280-764] procedures vs 332 [186-569] procedures; P < .001) and ICD (114 [56-220] procedures vs 62 [25-124] procedures; P < .001). Compared with nonparticipating hospitals, an increased mean (SD) proportion of participating hospitals adhered to composite discharge medications after PCI (0.96 [0.03] vs 0.92 [0.07]; P < .001) and ICD (0.88 [0.10] vs 0.81 [0.12]; P < .001). Hospital factors associated with enrollment included participation in 5 or more NCDR registries (odds ratio [OR],1.98; 95% CI, 1.24-3.19; P = .005), membership in a larger hospital system (ie, 3-20 hospitals vs ≤2 hospitals in the system: OR, 2.29; 95% CI, 1.65-3.17; P = .001), participation in an NCDR pilot public reporting program of PCI 30-day readmissions (OR, 2.93; 95% CI, 2.19-3.91; P < .001), university affiliation (vs government affiliation: OR, 3.85, 95% CI, 1.03-14.29; P = .045; vs private affiliation: OR, 2.22; 95% CI, 1.35-3.57; P < .001), Midwest location (vs South: OR, 1.47; 95% CI, 1.06-2.08; P = .02), and increased comprehensive quality ranking (4 vs 1-2 performance stars in CathPCI: OR, 8.08; 95% CI, 5.07-12.87; P < .001; 4 vs 1 performance star in ICD: OR, 2.26; 95% CI, 1.48-3.44; P < .001) (C statistic = 0.829)., Conclusions and Relevance: This study found that one-third of eligible hospitals participated in the ACC voluntary public reporting program and that enrollment increased after the announcement that program participation would be considered by USNWR for hospital rankings. Several hospital characteristics, experience with public reporting, and quality of care were associated with increased odds of participation.

Background: The Department of Justice (DOJ) investigated implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria, resulting in increased adherence to the NCD criteria. Trends of the specific reasons for patients not meeting the NCD criteria and in-hospital outcomes for those patients are not known., Methods and Results: We analyzed 300,151 primary-prevention ICDs from 2007-2015 at 1809 hospitals. We calculated the rates of in-hospital adverse events and the proportion of ICDs not meeting the 4 NCD criteria before and after the announcement of the DOJ investigation, stratified by whether hospitals paid settlements to the DOJ. Most reductions in the use of devices in patients not meeting NCD criteria were in patients with recently diagnosed heart failure (15.5%-6.8% for settled; 13.5%-7.3% for nonsettled) and who had had a recent myocardial infarction (8.4%-1.3% for settled; 7.4% to 1.5% for nonsettled). Adverse-event rates were significantly higher for ICDs not meeting NCD criteria (odds ratio 1.26 for settled; P < 0.001; 1.18 for nonsettled; P = 0.001)., Conclusions: After the investigation, there was a rapid reduction in the placement of ICDs in patients with recent acute myocardial infarction or recent diagnosis of heart failure. Patients who did not meet NCD criteria experienced more in-hospital adverse events and higher mortality rates., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Whether the volume of coronavirus disease 2019 (COVID-19) hospitalizations is associated with outcomes has important implications for the organization of hospital care both during this pandemic and future novel and rapidly evolving high-volume conditions., Methods: We identified COVID-19 hospitalizations at US hospitals in the American Heart Association COVID-19 Cardiovascular Disease Registry with ≥10 cases between January and August 2020. We evaluated the association of COVID-19 hospitalization volume and weekly case growth indexed to hospital bed capacity, with hospital risk-standardized in-hospital case-fatality rate (rsCFR)., Results: There were 85 hospitals with 15,329 COVID-19 hospitalizations, with a median hospital case volume was 118 (interquartile range, 57, 252) and median growth rate of 2 cases per 100 beds per week but varied widely (interquartile range: 0.9 to 4.5). There was no significant association between overall hospital COVID-19 case volume and rsCFR (rho, 0.18, P = .09). However, hospitals with more rapid COVID-19 case-growth had higher rsCFR (rho, 0.22, P = 0.047), increasing across case growth quartiles (P trend = .03). Although there were no differences in medical treatments or intensive care unit therapies (mechanical ventilation, vasopressors), the highest case growth quartile had 4-fold higher odds of above median rsCFR, compared with the lowest quartile (odds ratio, 4.00; 1.15 to 13.8, P = .03)., Conclusions: An accelerated case growth trajectory is a marker of hospitals at risk of poor COVID-19 outcomes, identifying sites that may be targets for influx of additional resources or triage strategies. Early identification of such hospital signatures is essential as our health system prepares for future health challenges., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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

Primary prevention implantable cardioverter-defibrillators (ICDs) in patients with recent myocardial infarction or coronary revascularization and those with newly diagnosed or severe heart failure (HF) are considered non-evidence-based, as defined by pivotal randomized clinical trials. Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 - 1.52, p <0.0001) and at 1 year (HR = 1.19, CI: 1.15 - 1.24, p <0.0001), but similar mortality risk at 3 years (HR = 1.03, CI: 0.98 - 1.08, p = 0.2630). Risk of all-cause hospitalization was higher in patients with non-evidence-based ICDs at 90 days (HR = 1.17, CI: 1.14 - 1.20, p <0.0001), but the difference diminished at 1 year (HR = 1.04, CI 1.00 - 1.07, p = 0.0272) and at 3 years (HR = 0.94, CI: 0.90 - 0.99, p = 0.0105). In conclusion, among patients undergoing primary prevention ICD implantations between 2010 and 2013, those with non-evidence-based ICDs were at increased risk of mortality and readmission during longitudinal follow-up. Differences in the risk of mortality and hospitalization were highest in the first year following device implantation., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background/objectives: Advanced age is associated with increased susceptibility to acute adverse effects of propofol. The present study aimed to describe patterns of propofol dosing for induction of general anesthesia before endotracheal intubation in a nationwide sample of older adults presenting for surgery., Design: Retrospective observational study using the Multicenter Perioperative Outcomes Group data set., Setting: Thirty-six institutions across the United States., Participants: A total of 350,766 patients aged over 65 years who received propofol for general anesthetic induction and endotracheal intubation between 2014 and 2018., Intervention: None., Measurements: Total induction bolus dose of propofol administered., Results: The mean (SD) weight-adjusted propofol dose was 1.7 (0.6) mg/kg. The mean prevalent propofol induction dose exceeded the upper bound of what has been described as the typical geriatric dose requirement across every age category examined. The percent of patients receiving propofol induction doses above the described typical geriatric range was 64.8% (95% CI 64.6-65.0), varying from 73.8% among patients aged 65-69 to 45.8% among patients aged 80 and older., Conclusion: The present study of a large multicenter cohort demonstrates that prevalent propofol dosing commonly falls above the published typically required dose range for patients aged ≥65 in nationwide anesthetic practice. Widespread variability in induction dose administration remains incompletely explained by known patient variables. The nature and clinical consequences of these unexplained dosing decisions remain important topics for further study. Observed discordance between expected and actual induction dosing raises the question of whether there should be reconsideration of widespread provider practice or, alternatively, whether what is published as the typical propofol induction dose range should be revisited., (© 2021 The American Geriatrics Society.)

[Figure: see text].

Importance: After disparate results from observational and small randomized studies, the COMPLETE trial demonstrated superiority of multivessel (MV) percutaneous coronary intervention (PCI) over culprit-only PCI for ST-elevation myocardial infarction (STEMI)., Objective: To describe temporal trends and institutional variation of MV PCI use for STEMI in the United States to inform how new evidence may influence clinical practice., Design, Setting, and Participants: This cohort study included STEMI admissions involving MV disease from 1598 institutions in the National Cardiovascular Data Registry CathPCI Registry from the third quarter of 2009 to the first quarter of 2018. An MV PCI was defined as a PCI to a nonculprit lesion within 45 days of the index procedure., Exposures: Multivessel PCI, defined as placement of coronary stents in 2 or more major epicardial vessels or the staged placement of 1 or more coronary stents in a major epicardial vessel distinct from the index culprit vessel, within 45 days of the index PCI., Main Outcomes and Measures: Outcomes included the proportional use of MV PCI among STEMI admissions with MV disease, and the timing of MV PCI (an index procedure, a staged procedure during index hospitalization, or a postdischarge procedure within 45 days)., Results: Among 359 879 admissions with STEMI and MV disease, MV PCI was performed in 38.5% (n = 138 380; mean [SD] age of patients, 62.3 [12.3] years; 102 266 men [73.9%]) within 45 days. Of those receiving MV PCIs, 30.8% (n = 42 629) had a procedure performed during the index procedure, 31.6% (n = 43 696) as a staged procedure during the index hospitalization, and 37.6% (n = 52 055) within 45 days of discharge. Complete revascularization of all diseased arteries was performed in 76.2% (n = 105 389). From the third quarter of 2009 to the second quarter of 2013, MV PCI use declined by 10%, from 42.7% (3230 of 7572 cases) to a nadir of 32.7% (3386 of 10 342 cases), followed by an increase to 44.0% (5062 of 11 497 cases) by the fourth quarter of 2017. During this time, there was a 13.6% decline in use of postdischarge staged MV PCI (from 23.4% of STEMI cases [1772 of 7572 cases] in the third quarter of 2009 to 9.9% [1094 of 11 171 cases] in the fourth quarter of 2014) and an 12.5% increase in MV PCI performed during the index admission (from 19.3% [1458 of 7572 cases] in the third quarter of 2009 to 31.8% [3557 of 11 171 cases] in the first quarter of 2018). Multivessel PCI use varied substantially across institutions, with a median use of 37.9% (interquartile range, 30.0%-46.5%)., Conclusions and Relevance: In this large, nationwide analysis, MV PCI use for patients with STEMI has been increasing through early 2018 but was used in the minority of patients and with wide variability across US institutions. The adoption of new trial results into guidelines and practice may further promote the growth of MV PCI.

Introduction: The cardiac catheterization laboratory (CCL) is a focal point for cardiovascular programs and the CCL director represents the key personnel. We outline profiles of CCL directors at the 2017 U.S. News & World Report top 100 U.S. cardiovascular hospitals., Methods: Using hospital websites, LinkedIn, Healthgrades, Medicare Provider Utilization and Payment Data 2017, and Scopus, we described CCL directors (in 2017) by age, gender, years since medical graduation, international medical school graduate (IMG) status, academic rank, provider clinical focus, and Hirsch (h)-index., Results: Nearly all CCL directors were male (97%). The median age (interquartile range [IQR]) was 53 (49-61) years and median (IQR) years since medical school graduation was 28 (23-35) years. Over a third of CCL directors (39.4%) were IMGs and 38.4% had completed fellowship training at the same facility where they were CCL director. The median (IQR) h-index was 11 (6-22). Of the 69.7% CCL directors who held faculty positions, 60.9% were professors and 30.4% were associate professors. From Medicare data, 45.5% performed only percutaneous coronary interventions, 41.4% performed structural interventions, 3.0% peripheral interventions, and 2.0% performed both structural and peripheral. CCL directors at the top 25 hospitals had higher h-indexes, and more likely to have completed fellowship training at their own institution., Conclusions: There are very few women CCL directors at the top U.S. cardiovascular hospitals. A third of the CCL directors were IMGs. A significant proportion of CCL directors primarily performed structural interventions and trained at the same institution, more so at the top 25 hospitals., (© 2021 Wiley Periodicals LLC.)

Background: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries., Methods: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved., Results: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844)., Conclusion: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: Frequent right ventricular (RV) pacing can cause and exacerbate heart failure. Cardiac resynchronization therapy (CRT) has been shown to be associated with improved outcomes among patients with reduced left ventricular ejection fraction who need frequent RV pacing, but the patterns of use of CRT vs dual chamber (DC) devices and the associated outcomes among these patients in clinical practice is not known., Objective: To assess outcomes, variability in use of device type, and trends in use of device type over time among patients undergoing implantable cardioverter defibrillator (ICD) implantation who were likely to require frequent RV pacing but who did not have a class I indication for CRT., Design, Setting, and Participants: This retrospective cohort study used the National Cardiovascular Data Registry (NCDR) ICD Registry. A total of 3100 Medicare beneficiaries undergoing first-time implantation of CRT defibrillator (CRT-D) or DC-ICD from 2010 to 2016 who had a class I or II guideline ventricular bradycardia pacing indication but not a class I indication for CRT were included. Data were analyzed from August 2018 to October 2019., Exposures: Implantation of a CRT-D or DC-ICD., Main Outcomes and Measures: All-cause mortality, heart failure hospitalization, and complications were ascertained from Medicare claims data. Multivariable Cox proportional hazards models and Fine-Gray models were used to evaluate 1-year mortality and heart failure hospitalization, respectively. Multivariable logistic regression was used to evaluate 30-day and 90-day complications. All models accounted for clustering. The median odds ratio (MOR) was used to assess variability and represents the odds that a randomly selected patient receiving CRT-D at a hospital with high implant rates would receive CRT-D if they had been treated at a hospital with low CRT-D implant rates., Results: A total of 3100 individuals were included. The mean (SD) age was 76.3 (6.4) years, and 2500 (80.6%) were men. The 1698 patients (54.7%) receiving CRT-D were more likely than those receiving DC-ICD to have third-degree atrioventricular block (828 [48.8%] vs 432 [30.8%]; P < .001), nonischemic cardiomyopathy (508 [29.9%] vs 255 [18.2%]; P < .001), and prior heart failure hospitalizations (703 [41.4%] vs 421 [30.0%]; P < .001). Following adjustment, CRT-D was associated with lower 1-year mortality (hazard ratio [HR], 0.70; 95% CI, 0.57-0.87; P = .001) and heart failure hospitalization (subdistribution HR, 0.77; 95% CI, 0.61-0.97; P = .02) and no difference in complications compared with DC-ICD. Hospital variation in use of CRT was present (MOR, 2.00), and the use of CRT in this cohort was higher over time (654 of 1351 [48.4%] in 2010 vs 362 of 594 [60.9%] in 2016; P < .001)., Conclusions and Relevance: In this cohort study of older patients in contemporary practice undergoing ICD implantation with a bradycardia pacing indication but without a class I indication for CRT, CRT-D was associated with better outcomes compared with DC devices. Variability in use of device type was observed, and the rate of CRT implantation increased over time.

Background: Data from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease., Methods: We matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data with International Classification of Diseases, Ninth Revision codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value, negative predictive value, and kappa statistics., Results: At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively; P =0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% versus 8.6%, respectively; P <0.001). The sensitivity and positive predictive value of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for myocardial infarction, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and negative predictive value for all outcomes ranged from 93.7% to 99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for myocardial infarction, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively., Conclusions: Claims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events.

Background: Current United States guidelines recommend troponin as the preferred biomarker in assessing for acute coronary syndrome, but recommendations are limited about which patients to test. Variations in troponin ordering may influence downstream health care utilization., Methods: We performed a cross-sectional analysis of 3,308,131 emergency department (ED) visits in all 121 acute care facilities within the Veterans Health Administration from 2015 to 2017. We quantified the degree to which case mix and facility characteristics accounted for variations in facility rates in troponin ordering. We then assessed the association between facility quartiles of risk-adjusted troponin ordering and downstream resource utilization [inpatient admissions, noninvasive testing (stress tests, echocardiograms), and invasive procedures (coronary angiograms, percutaneous coronary interventions, and coronary artery bypass grafting surgeries)]., Results: The proportion of ED visits with troponin orders ranged from 2.2% to 64.5%, with a median of 37.1%. Case mix accounted for 9.5% of the variation in troponin orders; case mix and differences in facility characteristics accounted for 34.6%. Facilities in the highest quartile of troponin ordering, as compared with those in the lowest quartile, had significantly higher rates of inpatient admissions, stress tests, echocardiograms, coronary angiograms, and percutaneous coronary intervention., Conclusions: Significant variation in troponin utilization exists across Veterans Health Administration facilities and that variation is not well explained by case mix alone. Facilities with higher rates of troponin ordering were associated with more downstream resource utilization.