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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

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

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.

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. We sought to evaluate whether patient body mass index (BMI) was associated with planned use and implantation failure of CRT-D therapy. 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. 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). 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.

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.

ObjectiveTo develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.DesignMixed qualitative-quantitative approach.SettingConvened seven meetings with stakeholders to obtain input and feedback on the tool.ParticipantsTeam 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.InterventionsWith 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.OutcomesAbstraction tool to evaluate the quality of informed consent documents.ResultsWe 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%.ConclusionsWe 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.

ObjectiveTo 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.DesignRetrospective observational study of informed consent documents.Setting25 US hospitals, diverse in size and geographical region.CohortAmong 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 outcomeThe 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.ResultsAmong 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.ConclusionAll 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.

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.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.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.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).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.

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 P P =0.029). Approximately 29.5% of women and 22.1% of men sought medical care for similar symptoms before their hospitalization ( P P 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.

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

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.

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 P 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.

Background Population-based measures of admissions among patients with chronic conditions are important quality indicators of Accountable Care Organizations (ACOs), yet there are challenges in developing measures that enable fair comparisons among providers. Methods On the basis of consensus standards for outcome measure development and with expert and stakeholder input on methods decisions, we developed and tested 2 models of risk-standardized acute admission rates (RSAARs) for patients with diabetes and heart failure using 2010-2012 Medicare claims data. Model performance was assessed with deviance R; score reliability was tested with intraclass correlation coefficient. We estimated RSAARs for 114 Shared Savings Program ACOs in 2012 and we assigned ACOs to 3 performance categories: no different, worse than, and better than the national rate. Results The diabetes and heart failure cohorts included 6.5 and 2.6 million Medicare Fee-For-Service beneficiaries aged 65 years and above, respectively. Risk-adjustment variables were age, comorbidities, and condition-specific severity variables, but not socioeconomic status or other contextual factors. We selected hierarchical negative binomial models with the outcome of acute, unplanned hospital admissions per 100 person-years. For the diabetes and heart failure measures, respectively, the models accounted for 22% and 12% of the deviance in outcomes and score reliability was 0.89 and 0.81. For the diabetes measure, 51 (44.7%) ACOs were no different, 45 (39.5%) were better, and 18 (15.8%) were worse than the national rate. The distribution of performance for the heart failure measure was 61 (53.5%), 37 (32.5%), and 16 (14.0%), respectively. Conclusion Measures of RSAARs for patients with diabetes and heart failure meet criteria for scientific soundness and reveal important variation in quality across ACOs.

Background— We examined the association between the use of remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICD) and all-cause mortality and rehospitalization among patients undergoing initial ICD implant. Methods and Results— A limited data set was constructed from Boston Scientific ALTITUDE Registry and National Cardiovascular Data Registry ICD Registry between January 2006 and March 2010. Vital status was determined using the Social Security Death Master File. All-cause mortality up to 3 years was compared in patients who used RPM with those who did not use RPM. Time-dependent frailty Cox models quantified the association between RPM use and all-cause mortality. Analyses were repeated in subgroups based on age, sex, race, ICD type, indication, and cardiomyopathy pathogenesis. Similar methodology examined the association between RPM use and all-cause rehospitalization in patients enrolled in Medicare fee-for-service patients ≥65 years. The study cohort (n=37 742, age 67±13, 72% male) had a 3-year mortality of 20.9% (median follow-up 832 days). In multivariable analyses, patients using RPM (n=22 023, 58%) had lower risk of mortality compared with those not using RPM (hazard ratio 0.67, 95% confidence interval 0.64–0.71, P P Conclusions— Among patients undergoing initial ICD implant, RPM use is associated with significantly lower risk of adverse outcomes.

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.

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.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).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).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.

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.

Long-term outcomes and predictors of mortality after implantable cardioverter-defibrillator (ICD) implantation related complication are unclear.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.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.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.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.

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 values0.05). 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 stays3 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.

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.

Importance Cardiac resynchronization therapy (CRT) reduces the risk for mortality and heart failure–related events in select patients. Little is known about the use of CRT in combination with an implantable cardioverter defibrillator (ICD) in patients who are eligible for this therapy in clinical practice. Objective To (1) identify patient, clinician, and hospital characteristics associated with CRT defibrillator (CRT-D) use and (2) determine the extent of hospital-level variation in the use of CRT-D among guideline-eligible patients undergoing ICD placement. Design, Setting, and Participants Multicenter retrospective cohort from 1428 hospitals participating in the National Cardiovascular Data Registry ICD Registry between April 1, 2010, and June 30, 2014. Adult patients meeting class I or IIa guideline recommendations for CRT at the time of device implantation were included in this study. Main Outcomes and Measures Implantation of an ICD with or without CRT. Results A total of 63 506 eligible patients (88.6%) received CRT-D at the time of device implantation. The mean (SD) ages of those in the ICD and CRT-D groups were 67.9 (12.2) years and 68.4 (11.5) years, respectively. In hierarchical multivariable models, black race was independently associated with lower use of CRT-D (odds ratio [OR], 0.77; 95% CI, 0.71-0.83) as was nonprivate insurance (OR, 0.90; 95% CI, 0.85-0.95 for Medicare and OR, 0.73; 95% CI, 0.65-0.82 for Medicaid). Clinician factors associated with greater CRT-D use included clinician implantation volume (OR, 1.01 per 10 additional devices implanted; 95% CI, 1.01-1.01) and electrophysiology training (OR, 3.13 as compared with surgery-boarded clinicians; 95% CI, 2.50-3.85). At the hospital level, the overall median risk-standardized rate of CRT-D use was 79.9% (range, 26.7%-100%; median OR, 2.08; 95% CI, 1.99-2.18). Conclusions and Relevance In a national cohort of patients eligible for CRT-D at the time of device implantation, nearly 90% received a CRT-D device. However, use of CRT-D differed by race and implanting operator characteristics. After accounting for these factors, the use of CRT-D continued to vary widely by hospital. Addressing disparities and variation in CRT-D use among guideline-eligible patients may improve patient outcomes.

Objective: The aim of the study was to examine how psychological stress changes over time in young and middle-aged patients after experiencing an acute myocardial infarction (AMI) and whether these changes differ between men and women. Methods: We analyzed data obtained from 2358 women and 1151 men aged 18 to 55 years hospitalized for AMI. Psychological stress was measured using the 14-item Perceived Stress Scale (PSS-14) at initial hospitalization and at 1 month and 12 months after AMI. We used linear mixed-effects models to examine changes in PSS-14 scores over time and sex differences in these changes, while adjusting for patient characteristics and accounting for correlation among repeated observations within patients. Results: Overall, patients' perceived stress decreased over time, especially during the first month after AMI. Women had higher levels of perceived stress than men throughout the 12-month period (difference in PSS-14 score = 3.63, 95% confidence interval = 3.08 to 4.18, p < .001), but they did not differ in how stress changed over time. Adjustment for patient characteristics did not alter the overall pattern of sex difference in changes of perceived stress over time other than attenuating the magnitude of sex difference in PSS-14 score (difference between women and men = 1.74, 95% confidence interval = 1.32 to 2.16, p < .001). The magnitude of sex differences in perceived stress was similar in patients with versus without post-AMI angina, even though patients with angina experienced less improvement in PSS-14 score than those without angina. Conclusions: In young and middle-aged patients with AMI, women reported higher levels of perceived stress than men throughout the first 12 months of recovery. However, women and men had a similar pattern in how perceived stress changed over time.

Background— The rate of implantable cardioverter-defibrillator (ICD) infections has been increasing faster than that of implantation. We sought to determine the rate and predictors of ICD infection in a large cohort of Medicare patients. Methods and Results— Cases submitted to the ICD Registry from 2006 to 2009 were matched to Medicare fee-for-service claims data using indirect patient identifiers. ICD infections occurring within 6 months of hospital discharge after implantation were identified by ICD-9 codes. Logistic regression was used to examine factors associated with risk of ICD infection. Of 200 909 implants, 3390 patients (1.7%) developed an ICD infection. The infection rate was 1.4%, 1.5%, and 2.0% for single, dual, and biventricular ICDs, respectively ( P P Conclusions— Patients who developed an ICD infection were more likely to have had peri-ICD implant complications requiring early reintervention, previous valve surgery, device replacement for reasons other than battery depletion, and increased comorbidity burden. Efforts should be made to carefully consider when to reenter the pocket at any time other than battery replacement.

Background Prior studies have suggested that women have better outcomes than men after cardiac resynchronization therapy-defibrillator (CRT-D) implantation. Objectives The purpose of this study was to compare mortality after CRT-D implantation by sex, QRS morphology, and duration. Methods Survival curves and covariate adjusted hazard ratios (HR) were used to assess mortality by sex in 31,892 CRT-D patients in the National Cardiovascular Data Registry (NCDR), implantable cardioverter defibrillator (ICD) registry between 2006 and 2009, with up to 5 years’ follow-up (median 2.9 years, interquartile range: 2.0 to 3.9 years). Patients were grouped by QRS morphology and 10-ms increments in QRS duration. Results Among patients with left bundle branch block (LBBB), women had a 21% lower mortality risk than men (HR: 0.79; 95% CI: 0.74 to 0.84; p Conclusions Among patients with LBBB who received CRT-D, mortality is lower in women than men. Additionally, longer QRS duration in LBBB is associated with better survival in both sexes. In contrast, there is no sex difference in patients without LBBB, regardless of QRS duration. Further studies should include a non-CRT comparator group to confirm these findings.

Background— Recent studies show an association between neighborhood-level measures of socioeconomic status (SES) and outcomes for patients with heart failure. We do not know whether neighborhood SES has a primary effect or is a marker for individual SES. Methods and Results— We used the data from participants of the Telemonitoring to Improve Heart Failure Outcomes (Tele-HF) trial, recruited from 33 US internal medicine and cardiology practices and examined the association between neighborhood SES and outcomes of patients with heart failure. We used census tracts as proxies for neighborhoods and constructed summary SES scores that included information about wealth and income, education, and occupation. The primary end points were readmission and all-cause mortality at 6 months. We conducted patient interviews and medical chart reviews to obtain demographic information, clinical factors, therapies, and individual SES. We included 1557 patients: 524, 516, and 517 from low, medium, and high SES neighborhoods, respectively (mean age, 61.1±15.2 years; 42.2% women).Overall, 745 patients (47.8%) had ≥1 readmission and 179 patients (11.5%) died. When compared with patients in high SES neighborhoods, those living in low-SES neighborhoods were more likely to be readmitted (odds ratio, 1.35; 95% confidence interval, 1.01–1.82), but the mortality rates were not significantly different (odds ratio, 0.78; 95% confidence interval, 0.50–1.18). The results were consistent after multivariable adjustments for individual demographics, clinical factors, and individual SES. Conclusions— Among patients with heart failure, neighborhood SES was significantly associated with 6-month all-cause readmission even after adjusting for other patient-level factors, including individual SES. Greater number of events and longer follow-up is required to ascertain the potential effect of neighborhood SES on mortality. Clinical Trial Registration— URL: http://clinicaltrials.gov/ . Unique identifier: NCT00303212.

Objectives To better inform patients and physicians of the expected risk of adverse events and to assist hospitals9 efforts to improve the outcomes of patients undergoing implantable cardioverter-defibrillator (ICD) implantation, we developed and validated a risk model using data from the NCDR (National Cardiovascular Data Registry) ICD Registry. Background ICD prolong life in selected patients, but ICD implantation carries the risk of periprocedural complications. Methods We analyzed data from 240,632 ICD implantation procedures between April 1, 2010, and December 31, 2011 in the registry. The study group was divided into a derivation (70%) and a validation (30%) cohort. Multivariable logistic regression was used to identify factors associated with in-hospital adverse events (complications or mortality). A parsimonious risk score was developed on the basis of beta estimates derived from the logistic model. Hierarchical models were then used to calculate risk-standardized complication rates to account for differences in case mix and procedural volume. Results Overall, 4,388 patients (1.8%) experienced at least 1 in-hospital complication or death. Thirteen factors were independently associated with an increased risk of adverse outcomes. Model performance was similar in the derivation and validation cohorts (C-statistics = 0.724 and 0.719, respectively). The risk score characterized patients into low- and-high risk subgroups for adverse events (≤10 points, 0.3%; ≥30 points, 4.2%). The risk-standardized complication rates varied significantly across hospitals (median: 1.77, interquartile range 1.54, 2.14, 5th/95th percentiles: 1.16/3.15). Conclusions We developed a simple model that predicts risk for in-hospital adverse events among patients undergoing ICD placement. This can be used for shared decision making and to benchmark hospital performance.

Background: A prolonged PR interval is common among cardiac resynchronization therapy (CRT) candidates; however, the association between PR interval and outcomes is unclear, and the data are conflicting. Methods: We conducted inverse probability weighted analyses of 26 451 CRT-eligible (ejection fraction ≤35, QRS ≥120 ms) patients from the National Cardiovascular Data Registry ICD Registry to assess the association between a prolonged PR interval (≥230 ms), receipt of CRT with defibrillator (CRT-D) versus implantable cardioverter defibrillator (ICD), and outcomes. We first tested the association between a prolonged PR interval and outcomes among patients stratified by device type. Next, we performed a comparative effectiveness analysis of CRT-D versus ICD among patients when stratified by PR interval. Using Medicare claims data, we followed up with patients up to 5 years for incident heart failure hospitalization or death. Results: Patients with a PR≥230 ms (15%; n=4035) were older and had more comorbidities, including coronary artery disease, atrial arrhythmias, diabetes mellitus, and chronic kidney disease. After risk adjustment, a PR≥230 ms (versus PRP P =0.17) ( P interaction =0.043). CRT-D (versus ICD) was associated with lower rates of heart failure hospitalization or death among patients with PRP P =0.90) ( P interaction =0.0025). Conclusions: A PR≥230 ms is associated with increased rates of heart failure hospitalization or death among CRT-D patients. The real-world comparative effectiveness of CRT-D (versus ICD) is significantly less among patients with a PR≥230 ms in comparison with patients with a PR

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

The recent DANISH-ICD trial challenged the benefit of ICD in patients with NICM. We describe characteristics, and outcomes of elderly NICM patients with ICD/CRT in the NCDR ICD Registry. Using the NCDR ICD Registry linked with CMS claims, we identified 14,701 patients with NICM receiving de novo

Background— Large-scale data on outcomes with cardiac resynchronization therapy with defibrillator in patients with diabetes mellitus are limited. We compared outcomes after cardiac resynchronization therapy with defibrillator implantation among patients with heart failure who have diabetes mellitus versus those without diabetes mellitus. Methods and Results— Survival curves and covariate adjusted hazard ratio (HR) or odds ratio were used to assess the risks for death, readmission, and device-related complications by diabetes mellitus status among 18 428 patients at least 65 years old receiving cardiac resynchronization therapy with defibrillator from the National Cardiovascular Data Registry, implantable cardioverter-defibrillator registry between 2006 and 2009, with up to 3 years of follow-up. Accounting for differences between groups, compared with those without diabetes mellitus (n=11 345), patients with diabetes mellitus (n=7083) had a higher risk of death both at 1 year (HR, 1.16 [95% confidence interval (CI), 1.05–1.29]; P =0.0037) and 3 years (HR, 1.21 [1.14–1.29]; P P P P P P =0.37). Interactions of age, sex, ischemic cardiomyopathy, renal failure, or QRS duration were not significant. Conclusions— In older patients with heart failure receiving cardiac resynchronization therapy with defibrillator, diabetes mellitus was independently associated with greater risks of death and rehospitalization, but similar risks of procedural complications.

Autism spectrum disorders (ASD) are primarily inherited, but perinatal or other environmental factors may also be important. In an analysis of 87,677 births from 1996 through 2002, insured by the South Carolina Medicaid program, birth weight was significantly inversely associated with the odds of ASD (OR = 0.78, p = .001 for each additional kilogram). Maternal pre-eclampsia/eclampsia was significantly associated with greater odds of ASD (OR = 1.85, p < .0001 without controlling for birth weight; OR = 1.69, p = .0005, when controlling for birth weight). We conclude that reduced birth weight partially mediates the association between pre-eclampsia/eclampsia and ASD. Additional research is needed to investigate the potential mechanism(s) by which pre-eclampsia/eclampsia may influence ASD risk.

AIM To examine the association between genitourinary infection during pregnancy and cerebral palsy (CP) in children. METHOD Medicaid and birth certificate data were obtained for 135 835 pregnant women with singleton births paid for by Medicaid from 1996 to 2002. Linked Medicaid billing data were obtained for their children in 2007. The association between maternal genitourinary infection and CP was modeled using generalized estimating equations. RESULTS Maternal genitourinary infection was significantly associated with CP (odds ratio [OR]=1.27, p=0.007). Additional analyses revealed that the association was strongly significant for preterm or low birthweight infants when maternal infection was diagnosed in the first two trimesters of pregnancy (OR=1.62, p

Quantitative trait loci (QTL) mapping is a growing field in statistical genetics. In plants, QTL detection experiments often feature replicates or clones within a specific genetic line. In this work, a Bayesian hierarchical regression model is applied to simulated QTL data and to a dataset from the Arabidopsis thaliana plants for locating the QTL mapping associated with cotyledon opening. A conditional model search strategy based on Bayesian model averaging is utilized to reduce the computational burden.

We appreciate the comments by Longtin et al about our recent article1 examining rates and risk factors for implantable cardioverter-defibrillator (ICD) infections in the ICD Registry. They raised concerns that 1 of our criteria may not have had sufficient specificity to identify accurately patients with true ICD-related infections. The criterion in question was the use of a MedPAR claims file showing a procedural code for ICD implantation during the same admission as an International Classification of Diseases, Ninth Revision, Clinical Modification code for sepsis, bacteremia, endocarditis, cellulitis, or fever. These patients were included in the Registry for an initial ICD or cardiac resynchronization therapy …

Background— Women have been under-represented in trials of cardiac resynchronization therapy-defibrillators (CRT-D). Previous studies suggest that women benefit from CRT-D at shorter QRS duration than men and that there may be no benefit of CRT-D in patients without left bundle branch block (LBBB) regardless of patient sex. Methods and Results— We compared sex-specific death risk in 75 079 patients with New York Heart Association class III or IV heart failure, reduced left ventricular ejection fraction, and prolonged QRS duration (≥120 ms) receiving either CRT-D or implantable cardioverter defibrillator in subgroups according to QRS morphology and 10-ms increments in QRS duration. We applied propensity score weighting to control for differences between treatments. Among patients with LBBB, women receiving CRT-D had a lower relative death risk than those receiving an implantable cardioverter-defibrillator (absolute difference, 11%; hazard ratio=0.74 [95% confidence interval, 0.68–0.81]). In men, the lower mortality with CRT-D versus implantable cardioverter defibrillator was less pronounced (absolute difference, 9%; hazard ratio=0.84 [0.79–0.89]; sex×device interaction P =0.025). In those without LBBB, the mortality difference was modest and did not differ between women and men (absolute difference, 3%; hazard ratio=0.88 [0.79–0.97] in women and absolute difference, 2%; hazard ratio=0.95 [0.91–0.998] in men; interaction P =0.17). In subgroups according to QRS duration, CRT-D was associated with better survival in both sexes with LBBB and QRS ≥130 ms, whereas there was no clear relation between QRS duration and survival in patients without LBBB regardless of patient sex. Conclusions— In a large real-world population CRT-D was associated with a lower mortality risk in both sexes with LBBB, although more pronounced among women. Only among those with LBBB, both sexes had better survival with longer QRS duration. The mortality differences in patients without LBBB were attenuated in both sexes.

Background— Younger age and female sex are both associated with greater mental stress in the general population, but limited data exist on the status of perceived stress in young and middle-aged patients presenting with acute myocardial infarction. Methods and Results— We examined sex difference in stress, contributing factors to this difference, and whether this difference helps explain sex-based disparities in 1-month recovery using data from 3572 patients with acute myocardial infarction (2397 women and 1175 men) 18 to 55 years of age. The average score of the 14-item Perceived Stress Scale at baseline was 23.4 for men and 27.0 for women ( P P P Conclusions— Among young and middle-aged patients, higher stress at baseline is associated with worse recovery in multiple health outcomes after acute myocardial infarction. Women perceive greater psychological stress than men at baseline, which partially explains women’s worse recovery.

Background: Admissions among ambulatory patients with heart failure (HF) is a key quality metric for Accountable Care Organizations (ACOs). Yet HF patients are at risk for many acute illnesses, HF and non-HF related, and it is unknown whether specific types of admissions explain lower or higher ACO

This study sought to describe the use of CRT-D and its association with survival for older patients.Many patients who receive cardiac resynchronization therapy with defibrillator (CRT-D) in practice are older than those included in clinical trials.We identified patients undergoing ICD implantation in the National Cardiovascular Disease Registry (NCDR) ICD registry from 2006 to 2009, who also met clinical trial criteria for CRT, including left ventricular ejection fraction (LVEF) ≤35%, QRS ≥120 ms, and New York Heart Association (NYHA) functional class III or IV. NCDR registry data were linked to the social security death index to determine the primary outcome of time to death from any cause. We identified 70,854 patients from 1,187 facilities who met prior trial criteria for CRT-D. The mean age of the 58,147 patients receiving CRT-D was 69.4 years with 6.4% of patients age 85 or older. CRT use was 80% or higher among candidates in all age groups. Follow-up was available for 42,285 patients age ≥65 years at 12 months.Receipt of CRT-D was associated with better survival at 1 year (82.1% vs. 77.1%, respectively) and 4 years (54.0% vs. 46.2% , respectively) than in those receiving only an ICD (p 0.001). The CRT association with improved survival was not different for different age groups (p = 0.86 for interaction).More than 80% of older patients undergoing ICD implantation who were candidates for a CRT-D received the combined device. Mortality in older patients undergoing ICD implantation was high but was lower for those receiving CRT-D.

Background— Current guidelines recommend using remote patient monitoring (RPM) for implantable cardioverter-defibrillators, but the patterns of adoption of this technology have not been described. Successful use of RPM depends on (1) the enrollment of the patient into an RPM system and (2) subsequent activation of RPM by the enrolled patient. We examined RPM enrollment and activation rates and the patient, physician, and institutional determinants of RPM use. Methods and Results— Information about the use of RPM-capable devices was obtained from the Boston Scientific Corporation ALTITUDE program and linked to the National Cardiovascular Data Registry ICD Registry. Patients were first categorized as RPM-enrolled and RPM-not enrolled, and the RPM-enrolled patients were further categorized into RPM-active and RPM-inactive groups based on whether they transmitted RPM data. Variables associated with RPM enrollment and activation were identified with the use of multivariable logistic regression. Among 39 158 patients with newly implanted RPM-capable devices, 62% (n=24 113) were RPM-enrolled. Of those enrolled, 76% (n=18 289, or 47% of the entire cohort) activated their device. RPM enrollment was highly variable among institutions. The hospital-specific median odds ratio for RPM enrollment was 3.43, signifying that physician or institutional factors are associated with RPM enrollment. In contrast, the hospital-specific median odds ratio for RPM activation was 1.69. Age, race, health insurance, geographic location, and health-related factors were similarly associated with both RPM enrollment and activation. Conclusions— RPM technology is used in less than half of eligible patients. Lack of enrollment into RPM systems is the major cause of underutilization, and this primarily relates to the local practice environment.

Background— Cardiac perforation is a feared complication of implantable cardioverter-defibrillator (ICD) lead implantation because of the potential for significant morbidity and mortality. Predictors of perforation and the severity of associated adverse events have not been well studied. We sought to identify predictors of cardiac perforation from ICD lead implantation and subsequent outcomes. Methods and Results— We studied 440 251 first-time ICD recipients in the ICD Registry implanted between January 2006 and September 2011. Using hierarchical multivariable logistic regression adjusting for patient, implanting physician, and hospital characteristics, we examined the predictors of perforation and the association of perforation with other major complications, length of stay, and in-hospital mortality. Cardiac perforation occurred in 625 patients (0.14%). After multivariable adjustment, older age, female sex, left bundle branch block, worsened heart failure class, higher left ventricular ejection fraction, and non–single-chamber ICD implant were associated with a greater odds of perforation. Conversely, atrial fibrillation, diabetes mellitus, previous cardiac bypass surgery, and higher implanter procedural volume were associated with a lower odds of perforation (all P P 3 days (odds ratio, 16.3; 95% confidence interval, 13.7–19.4; P P Conclusions— In a large population of ICD recipients, specific patient and implanter characteristics predicted cardiac perforation risk. Cardiac perforation was associated with a substantially increased risk of other major complications, prolonged hospital stays, and death.

Coronary sinus (CS) dissection is a known complication during CRT-D implantation, but the overall incidence and clinical outcomes have not been extensively studied. We sought to describe predictors of CS dissection and consequent in-hospital adverse events in those with the complication. We studied