Search

Aims No prior study has been adequately powered to evaluate real-world safety outcomes in those receiving adjunctive ablation lesions beyond pulmonary vein isolation (PVI). We sought to evaluate characteristics and in-hospital complications among patients undergoing PVI with and without adjunctive lesions. Methods and results Patients in the National Cardiovascular Data Registry AFib Ablation Registry undergoing first-time atrial fibrillation (AF) ablation between 2016 and 2020 were identified and stratified into paroxysmal (PAF) and persistent AF, and separated into PVI only, PVI + cavotricuspid isthmus (CTI) ablation, and PVI + adjunctive (superior vena cava isolation, coronary sinus, vein of Marshall, atypical atrial flutter lines, other). Adjusted odds of adverse events were calculated using multivariable logistic regression. A total of 50 937 patients [PAF: 30 551 (60%), persistent AF: 20 386 (40%)] were included. Among those with PAF, there were no differences in the adjusted odds of complications between PVI + CTI or PVI + adjunctive when compared with PVI only. Among persistent AF, PVI + adjunctive was associated with a higher risk of any complication [3.0 vs. 4.5%, odds ratio (OR) 1.30, 95% confidence interval (CI) 1.07–1.58] and major complication (0.8 vs. 1.4%, OR 1.56, 95% CI 1.10–2.21), while no differences were observed in PVI + CTI compared with PVI only. Overall, there was high heterogeneity in adjunctive lesion type, and those receiving adjunctive lesions had a higher comorbidity burden. Conclusion Additional CTI ablation was common without an increased risk of complications. Adjunctive lesions other than CTI are commonly performed in those with more comorbidities and were associated with an increased risk of complications in persistent AF, although the current analysis is limited by high heterogeneity in adjunctive lesion set type. [ABSTRACT FROM AUTHOR]

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]

Objective: Older, relatively small studies identified female sex as a risk factor for adverse events after catheter ablation for atrial fibrillation (AF). We aimed to assess contemporary sex-based differences in baseline and procedural characteristics, adverse events, and quality of life among adults undergoing catheter ablation for AF.Methods: In this observational cohort study, we evaluated those enrolled in the National Cardiovascular Data Registry AFib Ablation Registry between January 2016 and September 2020. Using logistic regression, we analysed the association between patient sex and in-hospital adverse events.Results: Among 58 960 adults (34.6% women) from 150 centres undergoing AF ablation by 706 physicians, women were older (68 vs 64 years, p<0.001), had more comorbidities, and had lower AF-related quality of life at the time of ablation (mean Atrial Fibrillation Effect on QualiTy-of-life Questionnaire) score: 51.8 vs 62.2, p<0.001). Women had a higher risk of hospitalisation >1 day (adjusted OR (aOR) 1.41 (95% CI 1.33 to 1.49)), major adverse event (aOR 1.60 (95% CI 1.33 to 1.92)) and any adverse event (aOR 1.57 (95% CI 1.41 to 1.75)). Women had a higher risk of bradycardia requiring pacemaker, phrenic nerve damage, pericardial effusion, bleeding and vascular injury, but had no differences in death or acute pulmonary vein isolation.Conclusions: Among almost 60 000 patients in the largest prospective registry of AF ablation procedures, female sex was independently associated with a higher risk of hospitalisation >1 day, adverse events, and reduced quality of life, although there were no differences in death or acute pulmonary vein isolation. [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]

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. See related editorial by Devinney et al. in this issue. [ABSTRACT FROM AUTHOR]

Importance: Little is known about the association between industry payments and medical device selection.Objective: To examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D).Design, Setting, and Participants: In this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated.Exposures: Manufacturers' payments to physicians who performed an ICD or CRT-D implantation.Main Outcomes and Measures: The primary outcome of the study was the manufacturer of the device used for the implantation.Results: Over a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D.Conclusions and Relevance: In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually. [ABSTRACT FROM AUTHOR]

Background: Patients with comorbid conditions have a higher risk of mortality with SARS-CoV-2 (COVID-19) infection, but the impact on heart failure patients living near a disease hotspot is unknown. Therefore, we sought to characterize the prevalence and outcomes of COVID-19 in a live registry of heart failure patients across an integrated health care system in Connecticut. Methods: In this retrospective analysis, the Yale Heart Failure Registry (NCT04237701) that includes 26,703 patients with heart failure across a 6-hospital integrated health care system in Connecticut was queried on April 16th, 2020 for all patients tested for COVID-19. Sociodemographic and geospatial data as well as, clinical management, respiratory failure, and patient mortality were obtained via the real-time registry. Data on COVID-19 specific care was extracted by retrospective chart review. Results: COVID-19 testing was performed on 900 symptomatic patients, comprising 3.4% of the Yale Heart Failure Registry (N = 26,703). Overall, 206 (23%) were COVID- 19+. As compared to COVID-19-, these patients were more likely to be older, black, have hypertension, coronary artery disease, and were less likely to be on renin angiotensin blockers (P<0.05, all). COVID-19- patients tended to be more diffusely spread across the state whereas COVID-19+ were largely clustered around urban centers. 20% of COVID-19+ patients died, and age was associated with increased risk of death [OR 1.92 95% CI (1.33–2.78); P<0.001]. Among COVID-19+ patients who were ≥85 years of age rates of hospitalization were 87%, rates of death 36%, and continuing hospitalization 62% at time of manuscript preparation. Conclusions: In this real-world snapshot of COVID-19 infection among a large cohort of heart failure patients, we found that a small proportion had undergone testing. Patients found to be COVID-19+ tended to be black with multiple comorbidities and clustered around lower socioeconomic status communities. Elderly COVID-19+ patients were very likely to be admitted to the hospital and experience high rates of mortality. [ABSTRACT FROM AUTHOR]

Background: Cardiac resynchronization therapy with defibrillator (CRT-D) implantation involves left ventricular (LV) lead placement for biventricular pacing and is more complex than implantable cardioverter-defibrillator (ICD)-only implantation. Differences in the prescription of CRT-D versus ICD may result from clinician biases based on patient body habitus, and body habitus may be associated with LV lead implantation failure.Objective: We sought to evaluate whether patient body mass index (BMI) was associated with planned use and implantation failure of CRT-D therapy.Methods: We studied all patients enrolled in the National Cardiovascular Data Registry ICD Registry who met standard CRT-D criteria and received either an ICD or CRT-D between 2010 and 2012. BMI was categorized based on World Health Organization classification. Using hierarchical logistic regression, two multivariate models adjusted for patient demographic and clinical characteristics were fit based on the following outcome variables: (1) planned implantation with CRT-D versus ICD and (2) failed versus successful LV lead placement.Results: Of 337,547 patients, 41,872 met inclusion criteria for the first analysis and 35,186 met criteria for the second analysis. After multivariable adjustment, patients with extreme (BMI > 40 kg/m2) obesity were less likely to receive guideline-concordant CRT-D compared with patients with normal weight (adjusted odds ratio (AOR), 0.86; 95% confidence interval (CI), 0.75-0.99; p = 0.04). Extreme (BMI > 40 kg/m2) obesity was associated with higher odds of failed LV lead placement (AOR, 1.35; 95% CI, 1.07-1.72, p = 0.01).Conclusions: Compared with normal weight patients, extremely obese (BMI > 40 kg/m2) CRT-D eligible patients were less likely to be prescribed CRT-D and were at higher odds for failed LV lead placement. [ABSTRACT FROM AUTHOR]

Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice.Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices.Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017.Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only.Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding.Results: Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI.Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients. [ABSTRACT FROM AUTHOR]

Aims The prognosis of patients with MINOCA (myocardial infarction with non-obstructive coronary arteries) is poorly understood. We examined major adverse cardiac events (MACE) defined as all-cause mortality, re-hospitalization for acute myocardial infarction (AMI), heart failure (HF), or stroke 12-months post-AMI in patients with MINOCA versus AMI patients with obstructive coronary artery disease (MICAD). Methods and results Multicentre, observational cohort study of patients with AMI (≥65 years) from the National Cardiovascular Data Registry CathPCI Registry (July 2009–December 2013) who underwent coronary angiography with linkage to the Centers for Medicare and Medicaid (CMS) claims data. Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis. The primary endpoint was MACE at 12 months, and secondary endpoints included the components of MACE over 12 months. Among 286 780 AMI admissions (276 522 unique patients), 16 849 (5.9%) had MINOCA. The 12-month rates of MACE (18.7% vs. 27.6%), mortality (12.3% vs. 16.7%), and re-hospitalization for AMI (1.3% vs. 6.1%) and HF (5.9% vs. 9.3%) were significantly lower for MINOCA vs. MICAD patients (P < 0.001), but was similar between MINOCA and MICAD patients for re-hospitalization for stroke (1.6% vs. 1.4%, P  = 0.128). Following risk-adjustment, MINOCA patients had a 43% lower risk of MACE over 12 months (hazard ratio = 0.57, 95% confidence interval 0.55–0.59), in comparison to MICAD patients. This pattern was similar for adjusted risks of the MACE components. Conclusion This study confirms an unfavourable prognosis in elderly patients with MINOCA undergoing coronary angiography, with one in five patients with MINOCA suffering a major adverse event over 12 months. Open in new tab Download slide Open in new tab Download slide [ABSTRACT FROM AUTHOR]

Background: Cardiovascular implantable electronic devices (CIEDs) are associated with procedure-related complications, yet little is known about variation in complication rates among institutions that may suggest disparities in care quality.Objective: To assess institutional variation in risk-standardized complication rates (RSCRs) for CIED.Design: Cohort study.Setting: 174 hospitals in Australia and New Zealand, 98 of which implanted at least 25 CIEDs during the study period.Participants: 81 304 patients older than 18 years (mean, 74.7 years [SD, 12.4]; 37.9% female) who received a new CIED (65 711 permanent pacemakers [PPMs] and 15 593 implantable cardioverter-defibrillators [ICDs]) in 2010 to 2015.Measurements: RSCRs and frequencies of major device-related complications during hospitalization or within 90 days of discharge.Results: Of the cohort, 6664 patients (8.2%) had a major complication. Although complication rates were higher for ICDs than PPMs (10.04% vs. 7.76%), 76.5% of all complications were attributable to PPMs (5098 vs. 1566 for ICDs). Among hospitals that implanted at least 25 CIEDs, the median RSCR was 8.1%; however, rates varied from 5.3% to 14.3%, with 22 hospitals identified as having RSCRs that differed significantly from the national average. Similar variation was observed when RSCRs for PPM implantation (n = 96 hospitals) (median RSCR, 7.6% [range, 5.4% to 12.9%]) were considered separately from those for ICD placement (n = 68 hospitals) (median RSCR, 9.7% [range, 6.2% to 16.9%]) and persisted when only elective procedures were assessed (n = 88 hospitals) (median RSCR, 7.4% [range, 4.7% to 13.0%]).Limitation: Possible unmeasured confounding from the use of administrative data.Conclusion: CIED complications are common and vary among hospitals, suggesting institutional variation in CIED care quality. Concerted clinical and policy interventions are needed to address CIED-related complications. These efforts should preferentially target PPMs, because most CIED complications are attributable to these devices.Primary Funding Source: The Hospitals Contribution Fund Research Foundation. [ABSTRACT FROM AUTHOR]

Aims: To assess the association of body mass index (BMI) with heart failure (HF) outcomes after cardiac resynchronization therapy with defibrillator (CRT-D) implantation.Methods and Results: Medicare beneficiaries with HF aged ≥ 65 years (n = 18 922) undergoing first-time CRT-D from the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter-Defibrillator Registry between 2010 and 2013, were followed for 3 years post-implantation. Survival curves and covariate adjusted hazard ratio (aHR) or odds ratio were used to assess the risks for death, readmission, and device-related complications by BMI status. Of 18 922 HF patients receiving CRT-D, 5265 (27.8%) were normal weight, 6896 (37%) were overweight, 6318 (33.4%) were obese, and 353 (1.8%) were underweight. Compared to those of normal weight (BMI 18.5-24.9 kg/m2 ), underweight patients had a higher 3-year post-device implantation risk of death [aHR: 1.34 (95% confidence interval 1.09-1.65); P < 0.001] and of readmission [sub-aHR: 1.25 (1.09-1.42); P < 0.001]. The corresponding 3-year aHRs for death were 0.83 (0.77-0.89) for overweight, 0.74 (0.67-0.82) for obesity class I (BMI 30-34.9 kg/m2 ), 0.78 (0.68-0.90) for obesity class II (BMI 35-39.9 kg/m2 ), and 0.75 (0.60-0.93) for obesity class III (BMI ≥ 40 kg/m2 , P for all categories < 0.001). Individuals with class III obesity had a higher risk of readmission [sub-aHR: 1.17 (1.06-1.30)]. There were no differences in rates of device-related complications within 90 days across BMI categories.Conclusion: Most elderly patients with HF receiving CRT-D were overweight or obese. While being underweight was associated with greater risks of death and hospitalization, overweight and obese patients were at lower risk of death after CRT-D. [ABSTRACT FROM AUTHOR]

Background: Remote monitoring of implantable cardioverter‐defibrillators has been associated with reduced rates of all‐cause rehospitalizations and mortality among device recipients, but long‐term economic benefits have not been studied. Methods and Results: An economic model was developed using the PREDICT RM database comparing outcomes with and without remote monitoring. The database included patients ages 65 to 89 who received a Boston Scientific device from 2006 to 2010. Parametric survival equations were derived for rehospitalization and mortality to predict outcomes over a maximum time horizon of 25 years. The analysis assessed rehospitalization, mortality, and the cost‐effectiveness (expressed as the incremental cost per quality‐adjusted life year) of remote monitoring versus no remote monitoring. Remote monitoring was associated with reduced mortality; average life expectancy and average quality‐adjusted life years increased by 0.77 years and 0.64, respectively (6.85 life years and 5.65 quality‐adjusted life years). When expressed per patient‐year, remote monitoring patients had fewer subsequent rehospitalizations (by 0.08 per patient‐year) and lower hospitalization costs (by $554 per patient year). With longer life expectancies, remote monitoring patients experienced an average of 0.64 additional subsequent rehospitalizations with increased average lifetime hospitalization costs of $2784. Total costs of outpatient and physician claims were higher with remote monitoring ($47 515 vs $42 792), but average per patient‐year costs were lower ($6232 vs $6244). The base‐case incremental cost‐effectiveness ratio was $10 752 per quality‐adjusted life year, making remote monitoring high‐value care. Conclusion: Remote monitoring is a cost‐effective approach for the lifetime management of patients with implantable cardioverter‐defibrillators. [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: 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: Machine learning methods may complement traditional analytic methods for medical device surveillance. Methods and results: Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%-20.9%; nonfatal ICDrelated adverse events, 19.3%-26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%-37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k=0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k=-0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k=-0.042). Conclusion: Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance. [ABSTRACT FROM AUTHOR]