Real-world clinical outcomes of oral anticoagulants among Japanese patients with atrial fibrillation and concomitant coronary artery disease.

Background: Stroke prevention is complicated in patients with atrial fibrillation (AF) and coronary artery disease (CAD). We compared the risk of major bleeding among Japanese patients with AF and CAD commencing warfarin, dabigatran, or rivaroxaban. Methods: This study included adults with AF and CAD who were newly prescribed the non-vitamin K antagonist oral anticoagulants (NOACs) dabigatran or rivaroxaban, or warfarin, and registered between 18 April 2011 through 31 December 2020 in the Medical Data Vision hospital-based clinical database. The primary outcome was major bleeding, and the secondary outcome was a composite of stroke, systemic embolism, myocardial infarction, all-cause inpatient mortality, major bleeding, major gastrointestinal bleeding, and intracerebral hemorrhage. Cox proportional hazard models with stabilized inverse probability treatment weighting were used to estimate hazard ratios (HRs) with 95 % CIs via a two-step approach; first between warfarin and each NOAC, then between NOACs if sample size conditions were met. Results: Dabigatran, rivaroxaban, and warfarin groups included 6712, 20,329, and 12,316 patients, respectively. Major bleeding risk was lower in NOACs versus warfarin (dabigatran: HR 0.50, 95 % CI: 0.40-0.62; rivaroxaban: HR 0.78, 95 % CI: 0.69-0.90); this risk was lower with dabigatran compared with rivaroxaban (HR 0.64, 95 % CI: 0.51─0.79). Net clinical benefit was superior to warfarin in both NOACs (dabigatran: HR 0.78, 95 % CI: 0.71-0.85; rivaroxaban: HR 0.83, 95 % CI: 0.78-0.88). Conclusions: Among real-world Japanese patients with AF and CAD, NOACs were associated with better clinical outcomes than warfarin. Treatment with dabigatran had a lower risk of major bleeding than rivaroxaban.Clinical trial registration: NCT05051904 (ClinicalTrials.gov).

Administrative Claims Measure for Profiling Hospital Performance Based on 90-Day All-Cause Mortality Following Coronary Artery Bypass Graft Surgery.

BACKGROUND: Coronary artery bypass graft (CABG) surgery is a focus of bundled and alternate payment models that capture outcomes up to 90 days postsurgery. While clinical registry risk models perform well, measures encompassing mortality beyond 30 days do not currently exist. We aimed to develop a risk-adjusted hospital-level 90-day all-cause mortality measure intended for assessing hospital performance in payment models of CABG surgery using administrative data. METHODS: Building upon Centers for Medicare and Medicaid Services hospital-level 30-day all-cause CABG mortality measure specifications, we extended the mortality timeframe to 90 days after surgery and developed a new hierarchical logistic regression model to calculate hospital risk-standardized 90-day all-cause mortality rates for patients hospitalized for isolated CABG. The model was derived from Medicare claims data for a 3-year cohort between July 2014 to June 2017. The data set was randomly split into 50:50 development and validation samples. The model performance was evaluated with C statistics, overfitting indices, and calibration plot. The empirical validity of the measure result at the hospital level was evaluated against the Society of Thoracic Surgeons composite star rating. RESULTS: Among 137 819 CABG procedures performed in 1183 hospitals, the unadjusted mortality rate within 30 and 90 days were 3.1% and 4.7%, respectively. The final model included 27 variables. Hospital-level 90-day risk-standardized mortality rates ranged between 2.04% and 11.26%, with a median of 4.67%. C statistics in the development and validation samples were 0.766 and 0.772, respectively. We identified a strong positive correlation between 30- and 90-day risk-standardized mortality rates, with a regression slope of 1.09. Risk-standardized mortality rates also showed a stepwise trend of lower 90-day mortality with higher Society of Thoracic Surgeons composite star ratings. CONCLUSIONS: We present a measure of hospital-level 90-day risk-standardized mortality rates following isolated CABG. This measure complements Centers for Medicare and Medicaid Services' existing 30-day CABG mortality measure by providing greater insight into the postacute recovery period. It offers a balancing measure to ensure efforts to reduce costs associated with CABG recovery and rehabilitation do not result in unintended consequences.

Comparison of left ventricular lead upgrade vs continued medical care among patients eligible for cardiac resynchronization therapy at the time of defibrillator generator replacement: Predictors of left ventricular lead upgrade and associations with long-term outcomes.

BACKGROUND: Randomized trials evaluating cardiac resynchronization therapy (CRT) have excluded patients with a pre-existing implantable cardioverter-defibrillator (ICD). The association of CRT upgrade with clinical outcomes in patients with a pre-existing ICD is unclear. OBJECTIVE: The purpose of this study was to examine a CRT-eligible population to evaluate clinical outcomes associated with CRT upgrade compared to patients who did not undergo CRT. METHODS: Using the National Cardiovascular Data Registry (NCDR) ICD Registry between April 2010 and December 2014, we created a hierarchical logistic regression model to identify predictors of CRT upgrade in a CRT-eligible ICD population. In the subpopulation of patients with Medicare-linked claims data, differential outcomes were determined with censoring at 3 years. The primary endpoint of this study was all-cause mortality, with secondary endpoints of rates of hospitalization and procedural complications. RESULTS: CRT upgrade was performed in 75.5% of CRT-eligible patients with pre-existing ICD (n = 15,803). Presence of left bundle branch block conduction was the strongest predictor of CRT upgrade (odds ratio [OR] 4.56; 95% confidence interval [CI] 4.08-5.11; P <.0001). In both unadjusted and adjusted analyses, CRT upgrade was associated with a reduction in mortality at 3 years (unadjusted hazard ratio [HR] 0.80; 95% CI 0.70-0.92; P = .001; adjusted HR 0.84; 95% CI 0.72-0.98; P = .02, respectively). Compared to patients with ICD generator replacement only, patients who underwent CRT upgrade experienced no different 3-year rates of hospitalization (adjusted HR 1.01; 95% CI 0.91-1.12; P = .81) or 1-year periprocedural complication rates (adjusted HR 1.07; 95% CI 0.79-1.45; P = .66). CONCLUSION: In a national registry of CRT-eligible patients with pre-existing ICD, upgrade to CRT was associated with lower rates of mortality than continued medical management.

An instrument for assessing the quality of informed consent documents for elective procedures: development and testing.

OBJECTIVE: To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures. DESIGN: Mixed qualitative-quantitative approach. SETTING: Convened seven meetings with stakeholders to obtain input and feedback on the tool. PARTICIPANTS: Team of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country. INTERVENTIONS: With stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals. OUTCOMES: Abstraction tool to evaluate the quality of informed consent documents. RESULTS: We identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%. CONCLUSIONS: We identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.

Quality of informed consent documents among US. hospitals: a cross-sectional study.

OBJECTIVE: To determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents. DESIGN: Retrospective observational study of informed consent documents. SETTING: 25 US hospitals, diverse in size and geographical region. COHORT: Among Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital. PRIMARY OUTCOME: The outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0-20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback. RESULTS: Among 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality. CONCLUSION: All hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital's informed consent documents can serve as a first step in driving attention to gaps in quality.

Stent selection among patients with chronic kidney disease: Results from the NCDR CathPCI Registry.

OBJECTIVES: This study sought to define contemporary rates of drug eluting stent (DES) usage in patients with chronic kidney disease (CKD). BACKGROUND: Among patients with CKD undergoing percutaneous coronary interventions (PCIs), outcomes are superior for those who receive DES compared to those who receive bare metal stents (BMSs). However, perceived barriers may limit the use of DES in this population. METHODS: All adult PCI cases from the NCDR CathPCI Registry involving coronary stent placement between July 1, 2009 and December 31, 2015 were analyzed. The rate of DES usage was then compared among four groups, stratified by CKD stage (I/II, III, IV, and V). Subgroup analysis was conducted based on PCI status and indication. Cases were linked to Medicare claims data to assess 1-year mortality. RESULTS: A total of 3,650,333 PCI cases met criteria for analysis. DES usage significantly declined as renal function worsened (83.0%, 79.9%, 75.6%, and 75.6%, respectively, in the four CKD stages; p < .001). DES usage was universally lower across the four groups in the setting of ST-Elevation Myocardial Infarction (STEMI) (70.6%, 66.5%, 58.7%, 58.0%; p < .001) and higher in the setting of elective PCI (87.6%, 84.9%, 82.3%, 77.9%; p < .0001). DES was associated with improved 1-year survival, and usage increased over time across each group. CONCLUSIONS: DESs are underutilized in patients with advanced renal dysfunction. Although DES usage has increased over time, variation still exists between patients with normal renal function and those with CKD.

Home Health Care After Skilled Nursing Facility Discharge Following Heart Failure Hospitalization.

BACKGROUND/OBJECTIVE: Heart failure (HF) readmission rates have plateaued despite scrutiny of hospital discharge practices. Many HF patients are discharged to skilled nursing facility (SNF) after hospitalization before returning home. Home healthcare (HHC) services received during the additional transition from SNF to home may affect readmission risk. Here, we examined whether receipt of HHC affects readmission risk during the transition from SNF to home following HF hospitalization. DESIGN: Retrospective cohort study. SETTING: Fee-for-service Medicare data, 2012 to 2015. PARTICIPANTS: Beneficiaries, aged 65 years and older, hospitalized with HF who were subsequently discharged to SNF and then discharged home. MEASUREMENTS: The primary outcome was unplanned readmission within 30 days of discharge to home from SNF. We compared time to readmission between those with and without HHC services using a Cox model. RESULTS: Of 67 585 HF hospitalizations discharged to SNFs and subsequently discharged home, 13 257 (19.6%) were discharged with HHC, and 54 328 (80.4%) were discharged without HHC. Patients discharged home from SNFs with HHC had lower 30-day readmission rates than patients discharged without HHC (22.8% vs 24.5%; P < .0001) and a longer time to readmission. In an adjusted model, the hazard for readmission was 0.91 (0.86-0.95) with receipt of HHC. CONCLUSIONS: Recipients of HHC were less likely to be readmitted within 30 days vs those discharged home without HHC. This is unexpected, as patients discharged with HHC likely have more functional impairments. Since patients requiring a SNF stay after hospital discharge may have additional needs, they may particularly benefit from restorative therapy through HHC; however, only approximately 20% received such services. J Am Geriatr Soc 68:96-102, 2019.

Association of body mass index with cardiac resynchronization therapy intention and left ventricular lead implantation failure: insights from the NCDR implantable cardioverter-defibrillator registry.

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.

Body mass index and outcomes of cardiac resynchronization with implantable cardioverter-defibrillator therapy in older patients with heart failure.

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.

Cardiac Resynchronization Defibrillator Therapy for Nonspecific Intraventricular Conduction Delay Versus Right Bundle Branch Block.

BACKGROUND: The benefits of cardiac resynchronization therapy (CRT) in patients with non-left bundle branch block (LBBB) conduction abnormality have not been fully explored. OBJECTIVES: This study sought to evaluate clinical outcomes among Medicare-aged patients with nonspecific intraventricular conduction delay (NICD) versus right bundle branch block (RBBB) in patients eligible for implantation with a CRT with defibrillator (CRT-D). METHODS: Using the National Cardiovascular Data Registry implantable cardioverter-defibrillator (ICD) registry data between 2010 and 2013, the authors compared outcomes in CRT-eligible patients implanted with CRT-D versus ICD-only therapy among patients with NICD and RBBB. Also, among all CRT-D-implanted patients, the authors compared outcomes in those with NICD versus RBBB. Survival curves and multivariable adjusted hazard ratios (HRs) were used to assess outcomes including hospitalization and death. RESULTS: In 11,505 non-LBBB CRT-eligible patients, after multivariable adjustment, among patients with RBBB, CRT-D was not associated with better outcomes, compared with ICD alone, regardless of QRS duration. Among patients with NICD and a QRS ≥150 ms, CRT-D was associated with decreased mortality at 3 years compared with ICD alone (HR: 0.602; 95% confidence interval [CI]: 0.416 to 0.871; p = 0.0071). Among 5,954 CRT-D-implanted patients, after multivariable adjustment NICD compared with RBBB was associated with lower mortality at 3 years in those with a QRS duration of ≥150 ms (HR: 0.757; 95% CI: 0.625 to 0.917; p = 0.0044). CONCLUSIONS: Among non-LBBB CRT-D-eligible patients, CRT-D implantation was associated with better outcomes compared with ICD alone specifically in NICD patients with a QRS duration of ≥150 ms. Careful patient selection should be considered for CRT-D implantation in patients with non-LBBB conduction.

Use of Cardiac Resynchronization Therapy Defibrillator in US Hospitals.

Importance: Cardiac resynchronization therapy (CRT) provides significant reduction in morbidity and mortality in select patients with left ventricular systolic dysfunction and specific parameters of electrocardiographic evidence of dyssynchrony. Relative to the 2012 American College of Cardiology/American Heart Association/Heart Rhythm Society guideline update for patient selection, little is known about the contemporary use of CRT in the United States. Objective: To describe the use of CRT defibrillator (CRT-D) in the period around guideline revision. Design, Setting, and Participants: All patients undergoing new CRT-D implantations in the National Cardiovascular Data Registry for implantable cardioverter-defibrillators from January 1, 2012, to December 31, 2015, at 1710 participating hospitals were identified for this population-based study. Rates of CRT-D implantation that were concordant and discordant with the 2012 American College of Cardiology/American Heart Association/Heart Rhythm Society update of the 2008 guidelines for device-based therapy were determined. Analysis began in January 2012. Main Outcomes and Measures: Increase in guideline-concordant CRT-D implantation. Results: Among 135 253 patients undergoing initial CRT-D implantation, 88 923 were included in the study cohort, of which 73 859 implants (83.1%) were guideline concordant. The proportion of guideline-concordant devices increased from 81.2% (16 710 of 20 481) in 2012 to 84.2% (20 515 of 24 356) in 2015 (P for trend < .001). Significant clustering was noted with 33% (565 of 1710) of hospitals accounting for greater than 70% (10 545 of 15 065) of guideline-discordant CRT-D implants. Conduction abnormalities, in particular, underlying right bundle branch block (3597 [23.9%] vs 7425 [10.1%]; P < .001) and nonspecific intraventricular conduction delay (3341 [22.2%] vs 4769 [6.5%]; P < .001) were more common in those who received guideline-discordant devices. Conclusions and Relevance: Rates of guideline-concordant CRT-D implantation increased during the study. The major fraction of guideline-discordant implants were clustered at a minority of hospitals. Conduction abnormalities, particularly non-left bundle branch block and nonspecific intraventricular conduction delay, correlated with guideline-discordant implants indicating continued opportunity for dissemination and understanding of guideline updates.

Outcomes and costs of remote patient monitoring among patients with implanted cardiac defibrillators: An economic model based on the PREDICT RM database.

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.

Risk of Readmission After Discharge From Skilled Nursing Facilities Following Heart Failure Hospitalization: A Retrospective Cohort Study.

OBJECTIVE: Discharge to skilled nursing facilities (SNFs) is common in patients with heart failure (HF). It is unknown whether the transition from SNF to home is risky for these patients. Our objective was to study outcomes for the 30 days after discharge from SNF to home among Medicare patients hospitalized with HF who had subsequent SNF stays of 30 days or less. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: All Medicare fee-for-service beneficiaries 65 and older admitted during 2012-2015 with a HF diagnosis discharged to SNF then subsequently discharged home. MEASURES: Patients were followed for 30 days following SNF discharge. We categorized patients by SNF length of stay: 1 to 6 days, 7 to 13 days, and 14 to 30 days. For each group, we modeled time to a composite outcome of unplanned readmission or death after SNF discharge. Our model examined 0-2 days and 3-30 days post-SNF discharge. RESULTS: Our study included 67,585 HF hospitalizations discharged to SNF and subsequently discharged home. Overall, 16,333 (24.2%) SNF discharges to home were readmitted within 30 days of SNF discharge. The hazard rate of the composite outcome for each group was significantly increased on days 0 to 2 after SNF discharge compared to days 3 to 30, as reflected in their hazard rate ratios: for patients with SNF length of stay 1 to 6 days, 4.60 (4.23-5.00); SNF length of stay 7 to 13 days, 2.61 (2.45-2.78); SNF length of stay 14 to 30 days, 1.70 (1.62-1.78). CONCLUSIONS/IMPLICATIONS: The hazard rate of readmission after SNF discharge following HF hospitalization is highest during the first 2 days home. This risk attenuated with longer SNF length of stay. Interventions to improve postdischarge outcomes have primarily focused on hospital discharge. This evidence suggests that interventions to reduce readmissions may be more effective if they also incorporate the SNF-to-home transition.

Admission diagnoses among patients with heart failure: Variation by ACO performance on a measure of risk-standardized acute admission rates.

BACKGROUND: A key quality metric for Accountable Care Organizations (ACOs) is the rate of hospitalization among patients with heart failure (HF). Among this patient population, non-HF-related hospitalizations account for a substantial proportion of admissions. Understanding the types of admissions and the distribution of admission types across ACOs of varying performance may provide important insights for lowering admission rates. METHODS: We examined admission diagnoses among 220 Medicare Shared Savings Program ACOs in 2013. ACOs were stratified into quartiles by their performance on a measure of unplanned risk-standardized acute admission rates (RSAARs) among patients with HF. Using a previously validated algorithm, we categorized admissions by principal discharge diagnosis into: HF, cardiovascular/non-HF, and noncardiovascular. We compared the mean admission rates by admission type as well as the proportion of admission types across RSAAR quartiles (Q1-Q4). RESULTS: Among 220 ACOs caring for 227,356 patients with HF, the median (IQR) RSAARs per 100 person-years ranged from 64.5 (61.7-67.7) in Q1 (best performers) to 94.0 (90.1-99.9) in Q4 (worst performers). The mean admission rates by admission types for ACOs in Q1 compared with Q4 were as follows: HF admissions: 9.8 (2.2) vs 14.6 (2.8) per 100 person years (P < .0001); cardiovascular/non-HF admissions: 11.1 (1.6) vs 15.9 (2.6) per 100 person-years (P < .0001); and noncardiovascular admissions: 42.7 (5.4) vs 69.6 (11.3) per 100 person-years (P < .0001). The proportion of admission due to HF, cardiovascular/non-HF, and noncardiovascular conditions was 15.4%, 17.5%, and 67.1% in Q1 compared with 14.6%, 15.9%, and 69.4% in Q4 (P < .007). CONCLUSIONS: Although ACOs with the best performance on a measure of all-cause admission rates among people with HF tended to have fewer admissions for HF, cardiovascular/non-HF, and noncardiovascular conditions compared with ACOs with the worst performance (highest admission rates), the largest difference in admission rates were for noncardiovascular admission types. Across all ACOs, two-thirds of admissions of patients with HF were for noncardiovascular causes. These findings suggest that comprehensive approaches are needed to reduce the diverse admission types for which HF patients are at risk.

Characteristics and Outcomes of Pediatric Patients Who Undergo Placement of Implantable Cardioverter Defibrillators: Insights From the National Cardiovascular Data Registry.

Background Implantable cardioverter defibrillators (ICDs) are an important part of therapy for many patients, yet there is little data on population characteristics, complications, or system survival in pediatric patients. Methods A retrospective review of ICD recipients in the National Cardiovascular Data Registry ICD Registry was performed from 2010 to 2016. Patient characteristics and complications between pediatric (≤21 years) and adult populations (>21 years) were compared. Variables associated with complications and early device interventions within the pediatric cohort were evaluated using multivariate modeling. Results There were 562 209 total ICD implants, of which 3461 occurred in the pediatric cohort. Among the pediatric patients, 60% of implants were for primary prevention, and nonischemic cardiomyopathy was the most common underlying disease (60%). Over time, there was an increasing trend of both primary and secondary prevention ICD implantations ( P<0.05). Compared with adults, pediatric patients were more likely to have structural heart disease, hypertrophic cardiomyopathy, and channelopathy, and to receive a single-chamber device (all P<0.001). There was no difference in inhospital complications between the adult and pediatric cohorts (2.4% versus 2.6%, P=0.3). However, among the pediatric patients, lower weight, Ebstein anomaly, worse New York Heart Association class, dual chamber, and cardiac resynchronization therapy-defibrillator were associated with greater risk of complications. Although reintervention for generator replacement or upgrade was more common in adults, the time to reintervention was shorter in the pediatric cohort. Conclusions We observed an increasing trend in ICD device implantation among pediatric patients. The pediatric cohort had similar inhospital complication rates compared with adults but had a shorter time to reintervention.

Sex Differences in the Presentation and Perception of Symptoms Among Young Patients With Myocardial Infarction: Evidence from the VIRGO Study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients).

BACKGROUND: Some studies report that women are less likely to present with chest pain for acute myocardial infarction (AMI). Information on symptom presentation, perception of symptoms, and care-seeking behaviors is limited for young patients with AMI. METHODS: We interviewed 2009 women and 976 men aged 18 to 55 years hospitalized for AMI at 103 US hospitals participating in the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients). Structured patient interviews during the index AMI hospitalization were used to collect information on symptom presentation, perception of symptoms, and care-seeking behaviors. We compared patient characteristics and presentation information by sex. Multivariable hierarchical logistic regression was used to evaluate the association between sex and symptom presentation. RESULTS: The majority of women (87.0%) and men (89.5%) presented with chest pain (defined as pain, pressure, tightness, or discomfort). Women were more likely to present with ≥3 associated symptoms than men (eg, epigastric symptoms, palpitations, and pain or discomfort in the jaw, neck, arms, or between the shoulder blades; 61.9% for women versus 54.8% for men, P<0.001). In adjusted analyses, women with an ST-segment-elevation AMI were more likely than men to present without chest pain (odds ratio, 1.51; 95% confidence interval, 1.03-2.22). In comparison with men, women were more likely to perceive symptoms as stress/anxiety (20.9% versus 11.8%, P<0.001) but less likely to attribute symptoms to muscle pain (15.4% versus 21.2%, P=0.029). Approximately 29.5% of women and 22.1% of men sought medical care for similar symptoms before their hospitalization (P<0.001); however, 53% of women reported that their provider did not think these symptoms were heart-related in comparison with 37% of men (P<0.001). CONCLUSIONS: The presentation of AMI symptoms was similar for young women and men, with chest pain as the predominant symptom for both sexes. Women presented with a greater number of additional non-chest pain symptoms regardless of the presence of chest pain, and both women and their healthcare providers were less likely to attribute their prodromal symptoms to heart disease in comparison with men.

Coronary Venous Dissection from Left Ventricular Lead Placement During Cardiac Resynchronization Therapy With Defibrillator Implantation and Associated in-Hospital Adverse Events (from the NCDR ICD Registry).

Coronary venous dissection is a known complication of left ventricular lead placement during implantation of a cardiac resynchronization with defibrillator (CRT-D) system. A large-scale evaluation of the prevalence of coronary venous dissection and associated in-hospital clinical outcomes has not been performed. We sought to identify predictors of coronary venous dissection and evaluate subsequent in-hospital adverse events in those with the complication. We studied 140,991 first-time CRT-D recipients in the implantable cardioverter-defibrillator (ICD) Registry implanted between 2006 and 2011. Using hierarchical multivariable logistic regression adjusting for patient, implanting physician, and hospital characteristics, we examined predictors of coronary venous dissection and its association with other major complications, length of hospital stay, and in-hospital mortality. Coronary venous dissection occurred in 392 patients (0.28%). After multivariable adjustment, female gender and left bundle branch block were associated with greater odds of coronary venous dissection. Conversely, atrial fibrillation, previous coronary artery bypass graft, and higher implanter procedure volume were associated with lower odds of coronary venous dissection (all p values <0.05). After multivariable adjustment, CRT-D recipients with coronary venous dissection had greater odds of major complications (odds ratio [OR] 10.47, 95% confidence interval [CI] 6.75 to 16.24, p <0.0001), postprocedural hospital stays >3 days (OR 1.71, 95% CI 1.29 to 2.29, p <0.0001), but not in-hospital death (OR 0.78, 95% CI 0.12 to 5.25, p = 0.8012). In conclusion, in a large population of first-time CRT-D recipients, specific patient and implanter characteristics predicted coronary venous dissection risk. Coronary venous dissection was associated with major in-hospital complications and prolonged hospitalization, but not death.

Long-term morbidity and mortality after implantable cardioverter-defibrillator implantation with procedural complication: A report from the National Cardiovascular Data Registry.

BACKGROUND: Long-term outcomes and predictors of mortality after implantable cardioverter-defibrillator (ICD) implantation related complication are unclear. OBJECTIVE: The purpose of this study was to determine the risk of mortality and hospitalization after complication during ICD implantation and identify predictors of adverse outcomes. METHODS: We performed a retrospective registry study of Medicare beneficiaries who were first-time ICD recipients enrolled in the National Cardiovascular Data Registry ICD Registry between January 2006 and March 2010. Mortality and hospitalization rates were examined using Kaplan-Meier survival analysis and multivariable Cox proportional hazards regression analysis. Covariates associated with mortality 3 years after ICD implantation complication were investigated. RESULTS: The study cohort comprised 136,143 Medicare beneficiaries. Complications during the index hospitalization occurred in 7046 patients (5.18%), and complications within 90 days of device implantation occurred in 10,005 patients (7.34%). In adjusted analyses, complications within 90 days of implantation were associated with an increased risk of all-cause mortality at 1 year (hazard ratio [HR] 1.13; 95% confidence interval [CI] 1.05-1.20; P = .006) and 3 years (HR 1.09; 95% CI 1.05-1.13; P <.0001). These results were consistent for a combined endpoint of all-cause mortality or hospitalization. Patient, device, and hospital characteristics associated with 3-year mortality were similar between those with and those without complications. CONCLUSION: Among Medicare beneficiaries, the occurrence of complications within 90 days of ICD implantation was associated with increased risk of all-cause mortality and all-cause mortality or hospitalization at 1 and 3 years. Patient, procedure, and hospital characteristics associated with mortality at 3 years after implantation were similar regardless of whether acute procedural complication occurred.

Defining Multiple Chronic Conditions for Quality Measurement.

BACKGROUND/OBJECTIVE: Patients with multiple chronic conditions (MCCs) are a critical but undefined group for quality measurement. We present a generally applicable systematic approach to defining an MCC cohort of Medicare fee-for-service beneficiaries that we developed for a national quality measure, risk-standardized rates of unplanned admissions for Accountable Care Organizations. RESEARCH DESIGN: To define the MCC cohort we: (1) identified potential chronic conditions; (2) set criteria for cohort conditions based on MCC framework and measure concept; (3) applied the criteria informed by empirical analysis, experts, and the public; (4) described "broader" and "narrower" cohorts; and (5) selected final cohort with stakeholder input. SUBJECTS: Subjects were patients with chronic conditions. Participants included 21.8 million Medicare fee-for-service beneficiaries in 2012 aged 65 years and above with ≥1 of 27 Medicare Chronic Condition Warehouse condition(s). RESULTS: In total, 10 chronic conditions were identified based on our criteria; 8 of these 10 were associated with notably increased admission risk when co-occurring. A broader cohort (2+ of the 8 conditions) included 4.9 million beneficiaries (23% of total cohort) with an admission rate of 70 per 100 person-years. It captured 53% of total admissions. The narrower cohort (3+ conditions) had 2.2 million beneficiaries (10%) with 100 admissions per 100 person-years and captured 32% of admissions. Most stakeholders viewed the broader cohort as best aligned with the measure concept. CONCLUSIONS: By systematically narrowing chronic conditions to those most relevant to the outcome and incorporating stakeholder input, we defined an MCC admission measure cohort supported by stakeholders. This approach can be used as a model for other MCC outcome measures.

Addition of Blood Pressure and Weight Transmissions to Standard Remote Monitoring of Implantable Defibrillators and its Association with Mortality and Rehospitalization.

BACKGROUND: Among patients with implantable defibrillators (ICD), use of remote patient monitoring (RPM) is associated with lower risk of death and rehospitalization. Standard ICD RPM can be supplemented with weight and blood pressure data. It is not known whether standard RPM plus routine weight and blood pressure transmission (RPM+) is associated with better outcomes. METHODS AND RESULTS: RPM+ patients (n=4106) were compared with patients who only transmitted standard ICD RPM data (n=14 183). Logistic regression models identified patient, physician, and hospital characteristics associated with RPM+ utilization. Mortality and rehospitalization were examined using landmark analyses at 180 days after ICD implant in Medicare fee-for-service patients. In these analyses, we examined the independent association between RPM+ utilization and times to events up to 3 years after device implantation with Cox regression models. We further examined whether the association between RPM+ and outcomes varied by frequency or type of transmissions. Determinants of RPM+ utilization included impaired ejection fraction, cardiac resynchronization therapy, and institutional practice. The risk of mortality of RPM+ patients was similar to standard ICD RPM patients (hazard ratio, 1.06; 95% confidence interval, 0.94-1.19; P=0.34). RPM+ patients also had similar risks of all-cause hospitalization (subdistribution hazard ratio, 1.03; 95% confidence interval, 0.94-1.14; P=0.52), cardiovascular hospitalization (subdistribution hazard ratio, 0.92; 95% confidence interval, 0.83-1.02; P=0.15), or heart failure hospitalizations (subdistribution hazard ratio, 0.90; 95% confidence interval, 0.78-1.05; P=0.18). RPM+ transmission frequency was not associated with outcomes. CONCLUSIONS: In patients using standard ICD RPM, the added transmission of weight and blood pressure data was not associated with improved outcomes.