Assessment of Days Alive Out of Hospital as a Possible End Point in Trials of Stroke Prevention for Atrial Fibrillation: A ROCKET AF Analysis.

BACKGROUND: Days alive out of hospital (DAOH) is an objective and patient-centered net benefit end point. There are no assessments of DAOH in clinical trials of interventions for atrial fibrillation (AF), and it is not known whether this end point is of clinical utility in these populations. METHODS AND RESULTS: ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) was an international double-blind, double-dummy randomized clinical trial that compared rivaroxaban with warfarin in patients with atrial fibrillation at increased risk for stroke. We assessed DAOH using investigator-reported event data for up to 12 months after randomization in ROCKET AF. We assessed DAOH overall, by treatment group, and by subgroup, including age, sex, and comorbidities, using Poisson regression. The mean±SD number of days dead was 7.3±41.2, days hospitalized was 1.2±7.2, and mean DAOH was 350.7±56.2, with notable left skew. Patients with comorbidities had fewer DAOH overall. There were no differences in DAOH by treatment arm, with mean DAOH of 350.6±56.5 for those randomized to rivaroxaban and 350.7±55.8 for those randomized to warfarin (P=0.86). A sensitivity analysis found no difference in DAOH not disabled with rivaroxaban versus warfarin (DAOH not disabled, 349.2±59.5 days and 349.1 days±59.3 days, respectively, P=0.88). CONCLUSIONS: DAOH did not identify a treatment difference between patients randomized to rivaroxaban versus warfarin. This may be driven in part by the low overall event rates in atrial fibrillation anticoagulation trials, which leads to substantial left skew in measures of DAOH.

Diuretic Changes, Health Care Resource Utilization, and Clinical Outcomes for Heart Failure With Reduced Ejection Fraction: From the Change the Management of Patients With Heart Failure Registry.

BACKGROUND: Diuretics are a mainstay therapy for the symptomatic treatment of heart failure. However, in contemporary US outpatient practice, the degree to which diuretic dosing changes over time and the associations with clinical outcomes and health care resource utilization are unknown. METHODS: Among 3426 US outpatients with chronic heart failure with reduced ejection fraction in the Change the Management of Patients with Heart Failure registry with complete medication data and who were prescribed a loop diuretic, diuretic dose increase was defined as: (1) change to a total daily dose higher than their previous total daily dose, (2) addition of metolazone to the regimen, (3) change from furosemide to either bumetanide or torsemide, and the change persists for at least 7 days. Adjusted hazard ratios or rate ratios along with 95% CIs were reported for clinical outcomes among patients with an increase in oral diuretic dose versus no increase in diuretic dose. RESULTS: Overall, 796 (23%) had a diuretic dose increase (18 episodes per 100 patient-years). The proportion of patients with dyspnea at rest (38% versus 26%), dyspnea at exertion (79% versus 67%), orthopnea (32% versus 21%), edema (60% versus 43%), and weight gain (40% versus 23%) were significantly (all P <0.001) higher in the diuretic increase group. Baseline angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (hazard ratio, 0.75 [95% CI, 0.65-0.87]) use were associated with lower likelihood of diuretic increase over time. Patients with a diuretic dose increase had a significantly higher number of heart failure hospitalizations (rate ratio, 2.53 [95% CI, 2.10-3.05]), emergency department visits (rate ratio, 1.84 [95% CI, 1.56-2.17]), and home health visits (rate ratio, 1.88 [95% CI, 1.39-2.54]), but not all-cause mortality (hazard ratio, 1.10 [95% CI, 0.89-1.36]). Similarly, greater furosemide dose equivalent increases were associated with greater resource utilization but not with mortality, compared with smaller increases. CONCLUSIONS: In this contemporary US registry, 1 in 4 patients with heart failure with reduced ejection fraction had outpatient escalation of diuretic therapy over longitudinal follow-up, and these patients were more likely to have sign/symptoms of congestion. Outpatient diuretic dose escalation of any magnitude was associated with heart failure hospitalizations and resource utilization, but not all-cause mortality.

Assessment of Common Comorbidity Phenotypes Among Older Adults With Knee Osteoarthritis to Inform Integrated Care Models.

OBJECTIVE: To establish the frequency of concordant, discordant, and clinically dominant comorbidities among Medicare beneficiaries with knee osteoarthritis (KOA) and to identify common concordant condition subgroups. PARTICIPANTS AND METHODS: We used a 5% representative sample of Medicare claims data to identify beneficiaries who received a diagnosis of KOA between January 1, 2012, and September 30, 2015, and matched control group without an osteoarthritis (OA) diagnosis. Frequency of 34 comorbid conditions was categorized as concordant, discordant, or clinically dominant among those with KOA and a matched sample without OA. Comorbid condition phenotypes were characterized by concordant conditions and derived using latent class analysis among those with KOA. RESULTS: The study sample included 203,361 beneficiaries with KOA and 203,361 non-OA controls. The largest difference in frequency between the two cohorts was for co-occurring musculoskeletal conditions (23.7% absolute difference), chronic pain syndromes (6.5%), and rheumatic diseases (4.5%), all with a higher frequency among those with knee OA. Phenotypes were identified as low comorbidity (53% of cohort with classification), hypothyroid/osteoporosis (27%), vascular disease (10%), and high medical and psychological comorbidity (10%). CONCLUSIONS: Approximately 47% of Medicare beneficiaries with KOA in this sample had a phenotype characterized by one or more concordant conditions, suggesting that existing clinical pathways that rely on single or dominant providers might be insufficient for a large proportion of older adults with KOA. These findings could guide development of integrated KOA-comorbidity care pathways that are responsive to emerging priorities for personalized, value-based health care.

Disease Burden Following Non-Cardioembolic Minor Ischemic Stroke or High-Risk TIA: A GWTG-Stroke Study.

BACKGROUND: Limited real-world data are available on outcomes following non-cardioembolic minor ischemic stroke (IS) or high-risk transient ischemic attack (TIA), particularly in the United States (US). We examined outcomes and Medicare payments following any severity IS or TIA as well as the subgroup with minor IS or high-risk TIA. METHODS: Medicare beneficiaries >65 years were identified using US nationwide Get with the Guidelines (GWTG)-Stroke Registry linked to Medicare claims data. The cohort consisted of patients enrolled in Medicare fee-for-service plan, hospitalized with non-cardioembolic IS or TIA between 2011 and 2014, segmenting a subgroup with minor IS (National Institute of Health Stroke Scale [NIHSS] ≤5) or high-risk TIA (ABCD2-score ≥6) compatible with the THALES clinical trial population. Outcomes included functional status at discharge, clinical outcomes (all-cause mortality, ischemic stroke, and hemorrhagic stroke, individually and as a composite), hospitalizations, and population average inpatient Medicare payments following non-cardioembolic IS or TIA. RESULTS: The THALES-compatible cohort included 62,518 patients from 1471 hospitals. At discharge, 37.0% were unable to ambulate without assistance, and 96.2% were prescribed antiplatelet therapy. Cumulative incidences at 30 days, 90 days, and 1 year for the composite outcome were 3.7%, 7.6%, and 17.2% and 2.4%, 4.0%, and 7.3% for subsequent stroke. The mean Medicare payment for the index hospitalization was $7951. The cumulative all-cause inpatient Medicare spending per patient (with or without any subsequent admission) at 30 days and 1 year from discharge was $1451 and $8105, respectively. CONCLUSIONS: The burden of illness for minor IS/high-risk TIA patients indicates an important unmet need. Improved therapeutic options may offer a significant impact on both patient outcomes and Medicare spending.

The association of pre- and posthospital medication adherence in myocardial infarction patients.

BACKGROUND: Nonadherence to optimal medical therapy following myocardial infarction (MI) is associated with adverse clinical outcomes such as stent thrombosis, recurrent cardiovascular events, and death. Whether adherence to medications prior to MI predicts post-MI medication adherence is unknown. METHODS: We assessed adherence to P2Y12 inhibitors and statins before and after admission for MI among 8,147 MI patients who had Medicare insurance with Part D prescription coverage. Adherence was defined as a proportion of days covered with medication fills ≥80%. Multivariable logistic regression was used to assess the association between pre- and post-MI P2Y12 inhibitor adherence. As few patients were on P2Y12 inhibitors pre-MI, we also examined the association of pre-MI statin adherence with post-MI P2Y12 inhibitor and statin adherence. RESULTS: Pre-MI medication nonadherence was observed in 427 of 2,633 (16%) patients on preadmission P2Y12 inhibitors and 1,233 of 6,934 (18%) patients on preadmission statins. Nonadherent patients were more likely to be of nonwhite race and have multiple prior hospital admissions. Patients who were nonadherent to P2Y12 inhibitors pre-MI were substantially less likely to adhere to P2Y12 inhibitors at 90 days (adjusted odds ratio [OR] 0.33, 95% CI 0.25-0.43) and 1 year post-MI (adjusted OR 0.29, 95% CI 0.21-0.39) compared with patients who were adherent pre-MI. Pre-MI statin nonadherence was also associated with lower post-MI adherence to P2Y12 inhibitors at 90 days (adjusted OR 0.65, 95% CI 0.53-0.79) and 1 year (adjusted OR 0.37, 95% CI 0.29-0.54). CONCLUSIONS: Prior medication adherence predicts post-MI adherence to P2Y12 inhibitors. Increasing accessibility of medication adherence data in the medical record may be an important tool to identify patients at higher risk for post-MI medication nonadherence and target efforts to improve adherence.

Permanent pacemaker use among patients with heart failure and preserved ejection fraction: Findings from the Acute Decompensated Heart Failure National Registry (ADHERE) National Registry.

BACKGROUND: Heart failure with preserved ejection fraction may be associated with chronotropic incompetence, but little is known about the incidence and prevalence of permanent pacemaker use in this population or factors associated with its use. METHODS: We analyzed patients with heart failure with preserved ejection fraction (ie, left ventricular ejection fraction greater than 40%) from the ADHERE registry (2001-2006) linked with Medicare claims. We described the use of both prevalent and incident permanent pacemakers in heart failure with preserved ejection fraction and determined factors associated with pacemaker use with logistic regression models. RESULTS: Among 13,881 patients with heart failure with preserved ejection fraction, 3136 (22.6%) had a permanent pacemaker, and of these patients, 636 had a permanent pacemaker implanted during hospitalization. Permanent pacemaker use was more common among older patients (81 vs 79 years; P < .001), men (38% vs 34%; P < .001), patients with atrial fibrillation (58% vs 36%; P < .001), and patients with wider QRS duration (140 ms vs 94 ms; P < .001). Rates of digoxin, aldosterone antagonist, and loop diuretic use were slightly higher in patients with a permanent pacemaker compared with patients with no permanent pacemaker. Factors associated with both prevalent and incident pacemaker use included age, fast or slow heart rate, atrial fibrillation, and lower body mass index. CONCLUSIONS: Use of permanent pacemakers is relatively common among patients with heart failure with preserved ejection fraction.

Differences in Short- and Long-Term Outcomes Among Older Patients With ST-Elevation Versus Non-ST-Elevation Myocardial Infarction With Angiographically Proven Coronary Artery Disease.

BACKGROUND: Among older patients with acute myocardial infarction (MI), it remains uncertain whether there is a time-dependent difference in the risk of recurrent mortality and nonfatal cardiovascular and cerebrovascular events for those with ST-segment-elevation MI (STEMI) compared with those with non-ST-segment-elevation MI. METHODS AND RESULTS: Older patients ≥65 years with acute MI and significant coronary artery disease identified with coronary angiography from the ACTION Registry-GWTG (Get With the Guidelines) were linked to Medicare claims data from 2007 to 2010. We examined the unadjusted cumulative incidence of each outcome studied from hospital discharge through 2 years with log-rank tests and then performed a piece-wise proportional hazards modeling with 2 time periods: discharge to 90 days and 90 days to 2 years. Among the 46 199 patients linked with Medicare data, 17 287 (37.4%) presented with STEMI. Through 2 years, the unadjusted cumulative incidence of all-cause mortality (16.0% versus 19.8%; P<0.001) and the composite outcome (21.9% versus 27.9%; P<0.001) was lower for STEMI patients. Within the first 90 days, unadjusted rates of mortality (5.5% versus 5.3%) and the composite outcome (7.9% versus 8.1%) were similar but diverged from 90 days to 2 years (mortality, 11.1% versus 15.4%; P<0.001; composite outcome, 15.2% versus 21.5%; P<0.001). After multivariable adjustment, the adjusted risks of mortality and the composite outcome through 90 days were higher for STEMI patients, whereas risks of mortality and the composite outcome were attenuated from 90 days through 2 years. CONCLUSIONS: Among older acute MI patients with angiographically confirmed coronary artery disease discharged alive, STEMI patients (compared with non-ST-segment-elevation MI patients) were found to have a lower frequency of unadjusted postdischarge mortality and composite cardiovascular and cerebrovascular outcomes through 2 years after hospital discharge. This analysis provides unique insight into differential short- and long-term risks of ischemic cardiovascular and cerebrovascular outcomes by MI classification among older MI patients with confirmed coronary artery disease surviving to hospital discharge.

Treatment, Outcomes, and Adherence to Medication Regimens Among Dual Medicare-Medicaid-Eligible Adults With Myocardial Infarction.

Importance: Patients with dual Medicare-Medicaid eligibility have a higher burden of chronic disease conditions and increased health care utilization compared with patients with Medicare coverage alone, but the treatment patterns and outcomes of dual-eligible patients with myocardial infarction (MI) are unknown. Objective: To examine the association of dual-eligible status with clinical outcomes and adherence to medication regimens (hereinafter "medication adherence") among older adults after MI. Design, Setting, and Participants: In this retrospective study conducted from February 2015 to April 2016, we linked patients 65 years or older enrolled in a national myocardial infarction registry (the Acute Coronary Treatment Intervention Outcomes Network Registry-Get With the Guidelines [ACTION Registry-GWTG]) from July 1, 2007, to December 31, 2009, to Medicare claims data to obtain 1-year follow-up and medication adherence data. The ACTION Registry-GWTG is the largest quality-improvement registry of patients with MI in the United States. Included patients were all 65 years or older; had Medicare Parts A, B, and D; presented with MI; and survived to hospital discharge. Exposures: Dual Medicare and Medicaid eligibility. Main Outcomes and Measures: Death, readmission, major adverse cardiovascular events (death, recurrent MI, stroke), and medication adherence at 1 year. Results: Of 17 419 Medicare patients discharged alive after MI, 4674 (27%) were dual eligible. Dual-eligible patients were more likely to be female (64% vs 49%) and nonwhite (29% vs 6%), with a higher prevalence of comorbid conditions and more frequent presentation with non-ST elevation MI (non-STEMI) (75% vs 69%). Dual-eligible patients were less likely to receive primary percutaneous coronary intervention for STEMI (77% vs 81%), revascularization for non-STEMI (58% vs 65%), and prescription of secondary prevention medications at discharge. After multivariable adjustment, dual eligibility status was associated with a higher risk of readmission at 30 days (hazard ratio [HR], 1.16; 95% CI, 1.06-1.26), death at 1 year (HR, 1.24; 95% CI, 1.14-1.36), and major adverse cardiac events at 1 year (HR, 1.21; 95% CI, 1.12-1.31). Dual-eligible patients had higher 1-year adherence to medications prescribed at discharge (HR, 1.55; 95% CI, 1.39-1.74) than Medicare-only patients. Conclusions and Relevance: Compared with Medicare-only patients, older adults with dual Medicare-Medicaid eligibility presenting with MI have superior rates of medication adherence but higher rates of postdischarge readmission and adverse cardiovascular outcomes.

Outcomes According to Cardiac Catheterization Referral and Clopidogrel Use Among Medicare Patients With Non-ST-Segment Elevation Myocardial Infarction Discharged Without In-hospital Revascularization.

BACKGROUND: While use of P2Y12 receptor inhibitor is recommended by guidelines, few studies have examined its effectiveness among older non-ST-segment elevation myocardial infarction patients who did not undergo coronary revascularization. METHODS AND RESULTS: We included unrevascularized non-ST-segment elevation myocardial infarction patients ≥65 years discharged home from 463 ACTION Registry-GWTG hospitals from 2007 to 2010. Rates of discharge clopidogrel use were described for patients with no angiography, angiography without obstructive coronary artery disease (CAD; ≥50% stenosis in ≥1 vessel), and angiography with obstructive CAD. Two-year outcomes were ascertained from linked Medicare data and included composite major adverse cardiac events (defined as all-cause death, myocardial infarction readmission, or revascularization), and individual components. Outcomes associated with clopidogrel use were adjusted using inverse probability-weighted propensity modeling. Of 14 154 unrevascularized patients, 54.7% (n=7745) did not undergo angiography, 10.6% (n=1494) had angiography without CAD, and 34.7% (n=4915) had angiography with CAD. Discharge clopidogrel was prescribed for 42.2% of all unrevascularized patients: 37.8% without angiography, 34.1% without obstructive CAD at angiography, and 51.6% with obstructive CAD at angiography. Discharge clopidogrel use was not associated with major adverse cardiac events in any group: without angiography (adjusted hazard ratio [95% CI]: 0.99 [0.93-1.06]), angiography without CAD (1.04 [0.74-1.47]), and angiography with CAD (1.12 [1.00-1.25], Pinteraction=0.20). CONCLUSIONS: We found no association between discharge clopidogrel use and long-term risk of major adverse cardiac events among older, unrevascularized non-ST-segment elevation myocardial infarction patients. Clopidogrel use in this population requires further prospective evaluation.

Care Transitions After Acute Myocardial Infarction for Transferred-In Versus Direct-Arrival Patients.

BACKGROUND: Many patients in the United States require transfer from one hospital to another for acute myocardial infarction (MI) care. How well these transferred-in patients are transitioned back to their local community is unknown. METHODS AND RESULTS: We used linked Medicare claims data to examine postdischarge outcomes of 39 136 patients with acute MI aged ≥65 years discharged alive from 451 US hospitals in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines. Multivariable Cox modeling was used to compare the likelihood of outpatient clinic follow-up and risks of all-cause mortality and all-cause or cardiovascular readmission at 30 days post MI between transferred-in and direct-arrival patients. From 2007 to 2010, 14 060 of 39 136 patients (36%) required interhospital transfer for acute MI care, traveling a median of 43 miles (interquartile range, 27-68 miles; 77.6 km [interquartile range, 48.2-122.6 km]). Compared with those arriving directly, transferred-in patients with MI were slightly younger (median age, 73 versus 74; P<0.01) but less likely to have previous MI, heart failure, and previous revascularization than direct-arrival patients. Relative to direct-arrival patients, those transferred-in had a lower likelihood of outpatient follow-up within 30 days post discharge (risk-adjusted incidence, 69.9% versus 78.2%; hazard ratio [HR], 0.90; 95% confidence interval, 0.87-0.92) and higher adjusted 30-day all-cause and cardiovascular readmission risks (14.5% versus 14.0%; HRall-cause, 1.08; 95% confidence interval, 1.01-1.15 and 9.5% versus 9.1%; HRcardiovascular, 1.13; 95% confidence interval, 1.04-1.22). In contrast, risk-adjusted 30-day mortality was similar between transferred-in and direct arrivals (1.6% versus 1.6%; HR, 1.05; 95% confidence interval, 0.86-1.27). CONCLUSIONS: Transferred-in patients with acute MI are less likely to have outpatient clinic follow-up within 30 days and more likely to be readmitted within the first 30 days post discharge compared with direct-arrival patients. These results indicate room for improvement in the safe and seamless transition of care for transferred patients with MI traveling back to their home environments.

Comparative Effectiveness of Implantable Cardioverter Defibrillators for Primary Prevention in Women.

BACKGROUND: Clinical trials of implantable cardioverter defibrillators (ICDs) for primary prevention enrolled a limited number of women. We sought to examine clinical practice data to compare survival rates among women with heart failure with or without a primary prevention ICD. METHODS AND RESULTS: We linked data from 264 US hospitals included in the Get With The Guidelines for Heart Failure registry with data from the Centers for Medicare and Medicaid Services. From these sources, we propensity score matched 430 women with heart failure who received a primary prevention ICD to 430 women who did not; we further adjusted using a Cox proportional hazards model. Median follow-up was 3.4 and 3.0 years. For comparison, we matched 859 men receiving an ICD with 859 who did not; median follow-up was 3.9 versus 2.9 years. In the matched cohorts, an ICD was associated with similarly better survival in women (hazard ratio, 0.78; 95% confidence interval, 0.66-0.92; P=0.003) and men (hazard ratio, 0.76; 95% confidence interval, 0.67-0.87 P<0.001). There was no interaction between sex and presence of an ICD with respect to survival (P=0.79). CONCLUSIONS: Among patients with heart failure with reduced left ventricular ejection fraction, a primary prevention ICD was associated with a significant survival advantage among women and among men. These findings support guideline-directed use of primary prevention ICDs in eligible patients.

Association Between Comorbidities and Outcomes in Heart Failure Patients With and Without an Implantable Cardioverter-Defibrillator for Primary Prevention.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy is associated with improved outcomes in patients with heart failure (HF), but whether this association holds among older patients with multiple comorbid illnesses and worse HF burden remains unclear. METHODS AND RESULTS: Using the National Cardiovascular Data Registry's ICD Registry and the Get With The Guidelines-Heart Failure (GWTG-HF) registry linked with Medicare claims, we examined outcomes associated with primary-prevention ICD versus no ICD among HF patients aged ≥65 years in clinical practice. We included patients with an ejection fraction ≤35% who received (ICD Registry) and who did not receive (GWTG-HF) an ICD. Compared with patients with an ICD, patients in the non-ICD group were older and more likely to be female and white. In matched cohorts, the 3-year adjusted mortality rate was lower in the ICD group versus the non-ICD group (46.7% versus 55.8%; adjusted hazard ratio [HR] 0.76; 95% CI 0.69 to 0.83). There was no associated difference in all-cause readmission (HR 0.99; 95% CI 0.92 to 1.08) but a lower risk of HF readmission (HR 0.88; 95% CI 0.80 to 0.97). When compared with no ICD, ICDs were also associated with better survival in patients with ≤3 comorbidities (HR 0.77; 95% CI 0.69 to 0.87) and >3 comorbidities (HR 0.77; 95% CI 0.64 to 0.93) and in patients with no hospitalization for HF (HR 0.75; 95% CI 0.65 to 0.86) and at least 1 prior HF hospitalization (HR 0.69; 95% CI 0.58 to 0.82). In subgroup analyses, there were no interactions between ICD and mortality risk for comorbidity burden (P=0.95) and for prior HF hospitalization (P=0.46). CONCLUSION: Among older HF patients, ICDs for primary prevention were associated with lower risk of mortality even among those with high comorbid illness burden and prior HF hospitalization.

Primary prevention implantable cardioverter-defibrillators in older racial and ethnic minority patients.

BACKGROUND: Racial and ethnic minorities are under-represented in clinical trials of primary prevention implantable cardioverter-defibrillators (ICDs). This analysis investigates the association between primary prevention ICDs and mortality among Medicare, racial/ethnic minority patients. METHODS AND RESULTS: Data from Get With The Guidelines-Heart Failure Registry and National Cardiovascular Data Registry's ICD Registry were used to perform an adjusted comparative effectiveness analysis of primary prevention ICDs in Medicare, racial/ethnic minority patients (nonwhite race or Hispanic ethnicity). Mortality data were obtained from the Medicare denominator file. The relationship of ICD with survival was compared between minority and white non-Hispanic patients. Our analysis included 852 minority patients, 426 ICD and 426 matched non-ICD patients, and 2070 white non-Hispanic patients (1035 ICD and 1035 matched non-ICD patients). Median follow-up was 3.1 years. Median age was 73 years, and median ejection fraction was 23%. Adjusted 3-year mortality rates for minority ICD and non-ICD patients were 44.9% (95% confidence interval [CI], 44.2%-45.7%) and 54.3% (95% CI, 53.4%-55.1%), respectively (adjusted hazard ratio, 0.79; 95% CI, 0.63-0.98; P=0.034). White non-Hispanic patients receiving an ICD had lower adjusted 3-year mortality rates of 47.8% (95% CI, 47.3%-48.3%) compared with 57.3% (95% CI, 56.8%-57.9%) for those with no ICD (adjusted hazard ratio, 0.75; 95% CI, 0.67%-0.83%; P<0.0001). There was no significant interaction between race/ethnicity and lower mortality risk with ICD (P=0.70). CONCLUSIONS: Primary prevention ICDs are associated with lower mortality in nonwhite and Hispanic patients, similar to that seen in white, non-Hispanic patients. These data support a similar approach to ICD patient selection, regardless of race or ethnicity.

Survival after primary prevention implantable cardioverter-defibrillator placement among patients with chronic kidney disease.

BACKGROUND: Guidelines recommend that implantable cardioverter-defibrillator (ICD) candidates have an estimated longevity of ≥1 year. Longevity can be affected by chronic kidney disease (CKD). METHODS AND RESULTS: Using the National Cardiovascular Data Registry ICD registry linked with the Social Security Death Master File, we assessed the rate of death after primary prevention ICD placement between January 1, 2006, and December 31, 2007, according to CKD stage. Using Cox models, we identified factors associated with death among patients with CKD. Compared with patients without CKD (n=26,056), those with CKD (n=21,226) were older, less commonly men, more often white, and more frequently had comorbid illness. Compared with patients without CKD, patients with a glomerular filtration rate 30 to 60, glomerular filtration rate <30, and end-stage renal disease on dialysis had a higher risk of death after ICD placement (hazard ratio, 2.08; 95% confidence interval, 1.99-2.18; P<0.0001; hazard ratio, 4.20; 95% confidence interval, 3.92-4.50; P<0.0001; and hazard ratio, 4.80; 95% confidence interval, 4.46-5.17; P<0.0001, respectively). Corresponding 1-year death rates were 4.4%, 9.1%, 20.2%, and 22.4%. Among patients with CKD, factors associated with increased risk of death included CKD severity, age >65 years, heart failure symptoms, diabetes mellitus, lung disease, serum sodium <140 mEq/L, atrial fibrillation or flutter, and a lower ejection fraction. CONCLUSIONS: The risk of death after primary prevention ICD placement is proportional to CKD severity. Among patients with CKD, several factors are prognostically significant and could inform clinical decision making on primary prevention ICD candidacy.

Association between prophylactic implantable cardioverter-defibrillators and survival in patients with left ventricular ejection fraction between 30% and 35%.

IMPORTANCE: Clinical trials of prophylactic implantable cardioverter-defibrillators (ICDs) have included a minority of patients with a left ventricular ejection fraction (LVEF) between 30% and 35%. Because a large number of ICDs in the United States are implanted in such patients, it is important to study survival associated with this therapy. OBJECTIVE: To characterize patients with LVEF between 30% and 35% and compare the survival of those with and without ICDs. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of Medicare beneficiaries in the National Cardiovascular Data Registry ICD registry (January 1, 2006, through December 31, 2007) with an LVEF between 30% and 35% who received an ICD during a heart failure hospitalization and similar patients in the Get With The Guidelines-Heart Failure (GWTG-HF) database (January 1, 2005, through December 31, 2009) with no ICD. The analysis was repeated in patients with an LVEF less than 30%. There were 3120 patients with an LVEF between 30% and 35% (816 in matched cohorts) and 4578 with an LVEF less than 30% (2176 in matched cohorts). Propensity score matching and Cox models were applied. MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality; data were obtained from Medicare claims through December 31, 2011. RESULTS: There were no significant differences in the baseline characteristics of the matched groups (n = 408 for both groups). Among patients with an LVEF between 30% and 35%, there were 248 deaths in the ICD Registry group, within a median follow-up of 4.4 years (interquartile range, 2.7-4.9) and 249 deaths in the GWTG HF group, within a median follow-up of 2.9 years (interquartile range, 2.1-4.4). The risk of all-cause mortality in patients with an LVEF between 30% and 35% and an ICD was significantly lower than that in matched patients without an ICD (3-year mortality rates: 51.4% vs 55.0%; hazard ratio, 0.83 [95% CI, 0.69-0.99]; P = .04). Presence of an ICD also was associated with better survival in patients with an LVEF less than 30% (3-year mortality rates: 45.0% vs 57.6%; 634 and 660 total deaths; hazard ratio, 0.72 [95% CI, 0.65-0.81]; P < .001) (P = .20 for interaction). CONCLUSIONS AND RELEVANCE: Among Medicare beneficiaries hospitalized for heart failure and with an LVEF between 30% and 35% and less than 30%, survival at 3 years was better in patients who received a prophylactic ICD than in comparable patients with no ICD. These findings support guideline recommendations to implant prophylactic ICDs in eligible patients with an LVEF of 35% or less.

Payment source, quality of care, and outcomes in patients hospitalized with heart failure.

OBJECTIVES: The aim of this study was to analyze the relationship between payment source and quality of care and outcomes in heart failure (HF). BACKGROUND: HF is a major cause of morbidity and mortality. There is a lack of studies assessing the association of payment source with HF quality of care and outcomes. METHODS: A total of 99,508 HF admissions from 244 sites between January 2005 and September 2009 were analyzed. Patients were grouped on the basis of payer status (private/health maintenance organization, no insurance, Medicare, or Medicaid) with private/health maintenance organization as the reference group. RESULTS: The no-insurance group was less likely to receive evidence-based beta-blockers (adjusted odds ratio [OR]: 0.73; 95% confidence interval [CI]: 0.62 to 0.86), implantable cardioverter-defibrillator (OR: 0.59; 95% CI: 0.50 to 0.70), or anticoagulation for atrial fibrillation (OR: 0.73; 95% CI: 0.61 to 0.87). Similarly, the Medicaid group was less likely to receive evidence-based beta-blockers (OR: 0.86; 95% CI: 0.78 to 0.95) or implantable cardioverter-defibrillators (OR: 0.86; 95% CI: 0.78 to 0.96). Angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and beta-blockers were prescribed less frequently in the Medicare group (OR: 0.89; 95% CI: 0.81 to 0.98). The Medicare, Medicaid, and no-insurance groups had longer hospital stays. Higher adjusted rates of in-hospital mortality were seen in patients with Medicaid (OR: 1.22; 95% CI: 1.06 to 1.41) and in patients with reduced systolic function with no insurance. CONCLUSIONS: Decreased quality of care and outcomes for patients with HF were observed in the no-insurance, Medicaid, and Medicare groups compared with the private/health maintenance organization group.

Cardiogenic shock and heart failure post-percutaneous coronary intervention in ST-elevation myocardial infarction: observations from "Assessment of Pexelizumab in Acute Myocardial Infarction".

BACKGROUND: Mortality after ST-elevation myocardial infarction (STEMI) has reduced with reperfusion by primary percutaneous coronary intervention (PCI), which may have impacted on the adverse outcomes of cardiogenic shock (CS) and congestive heart failure (CHF). METHODS AND RESULTS: In the APEX-AMI trial, 5,745 patients with STEMI and planned primary PCI were randomly assigned pexelizumab or matching placebo. Post-randomization CS or CHF was adjudicated by a clinical endpoints committee. Treatment assignment to pexelizumab did not influence either endpoint or mortality rates. Cardiogenic shock developed in 196 patients (3.4%) at a median of 6.0 hours (interquartile range 3.9-28.3) post-randomization, and mortality at 90 days was 54.6%. Congestive heart failure occurred in 254 of patients (4.4%) at a median of 2.6 days (IQR 1.0-16.6), and mortality through 90 days was 10.2%; mortality among those with neither endpoint was 2.1%. Patients with CS or CHF were older, were more often female, and had more hypertension and diabetes, but smoked less compared with non-CS/CHF patients (all P < .05). Independent mortality predictors among those with CS or CHF were hyperlipidemia and a history of angina (interaction P = .011 and .008, respectively); procedural predictors among survivors to PCI were pre-PCI Thrombolysis In Myocardial Infarction (TIMI) flow 0-1 and post-PCI TIMI flow <3 (P = .013 and <.0001, respectively). CONCLUSIONS: Survival after CS remains poor despite aggressive reperfusion. Both CS and CHF remain the major causes of death among STEMI patients undergoing primary PCI. Future studies should examine treatments that aim to reduce mortality in these highest risk patients.

Ejection fraction assessment and survival: an analysis of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

BACKGROUND: Ejection fraction (EF) is an important method of mortality prediction among cardiac patients, and has been used to identify the highest risk patients for enrollment in the defibrillator primary prevention trials. Evidence suggests that measures of EF by different imaging modalities may not be equivalent. In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), the type of imaging modality for EF assessment was not mandated. METHODS: Baseline assessment of EF was performed using either echocardiography, radionuclide angiography (RNA), or contrast angiography. Multivariable analysis using a Cox proportional hazards model was used to examine whether the modality of assessing EF affected the likelihood of survival. RESULTS: Among the 2,521 patients enrolled in SCD-HeFT, EF was measured by RNA in 616 (24%), echocardiography in 1,469 (58%), and contrast angiography in 436 (17%). Mean EF as measured by RNA was 25.1% +/- 6.9%; by echocardiography, 23.8 +/- 6.9%; and by angiography, 21.9 +/- 6.9%. These measures were significantly different (P < .001), and each pairwise comparison differed significantly (P < .001 for each). Multivariable analysis showed no significant difference in survival between patients enrolled based on RNA versus echocardiography (HR 1.06, 95% CI 0.88-1.28), RNA versus angiography (HR 1.25, 95% CI 0.97-1.62), or echocardiography versus angiography (HR 1.18, 95% CI 0.94-1.48). CONCLUSIONS: Among patients enrolled in SCD-HeFT, the distribution of ejection fractions measured by radionuclide angiography differed from those measured by echocardiography or contrast angiograms. Survival did not differ according to modality of EF assessment.

Value of clinician assessment of hemodynamics in advanced heart failure: the ESCAPE trial.

BACKGROUND: We determined whether estimated hemodynamics from history and physical examination (H&P) reflect invasive measurements and predict outcomes in advanced heart failure (HF). The role of the H&P in medical decision making has declined in favor of diagnostic tests, perhaps due to lack of evidence for utility. METHODS AND RESULTS: We compared H&P estimates of filling pressures and cardiac index with invasive measurements in 194 patients in the ESCAPE trial. H&P estimates were compared with 6-month outcomes in 388 patients enrolled in ESCAPE. Measured right atrial pressure (RAP) was <8 mm Hg in 82% of patients with RAP estimated from jugular veins as <8 mm Hg, and was >12 mm Hg in 70% of patients when estimated as >12 mm Hg. From the H&P, only estimated RAP > or =12 mm Hg (odds ratio [OR] 4.6; P<0.001) and orthopnea > or =2 pillows (OR 3.6; P<0.05) were associated with pulmonary capillary wedge pressure (PCWP) > or =30 mm Hg. Estimated cardiac index did not reliably reflect measured cardiac index (P=0.09), but "cold" versus "warm" profile was associated with lower median measured cardiac index (1.75 vs. 2.0 L/min/m(2); P=0.004). In Cox regression analysis, discharge "cold" or "wet" profile conveyed a 50% increased risk of death or rehospitalization. CONCLUSIONS: In advanced HF, the presence of orthopnea and elevated jugular venous pressure are useful to detect elevated PCWP, and a global assessment of inadequate perfusion ("cold" profile) is useful to detect reduced cardiac index. Hemodynamic profiles estimated from the discharge H&P identify patients at increased risk of early events.