Reducing Hospital Readmissions and Increasing Time to Hospital Readmission in Blacks with Heart Failure

10th Annual National Summit on Health Disparities CBC Health Braintrust Meeting April 22 April 23, 2013, Washington, DC Reducing Hospital Readmissions and Increasing Time to Hospital Readmission in Blacks with Heart Failure Inder S. Anand, MD, FRCP, D Phil, (Oxon.) Professor of Medicine, Cardiovascular Division University of Minnesota Medical School Director of Heart Failure Clinic VA Medical Center Minneapolis, Minnesota

A-HeFT All-Cause Mortality N=86 32/542 HR=0.57 (95% CI 0.37-0.89) P=0.012 54/518 Taylor et al. NEJM 2004;351:2049-57.

A-HeFT Time To Death Or First Heart Failure Hospitalization N=266 Taylor et al. Circulation. 2007;115:1747-53

A-HeFT Cumulative All-Cause Mortality N=86 HR=0.57 (95% CI 0.37-0.89) P=0.012

A-HeFT Time To Death and Time to First HF Hospitalization N=86 N=215 HR=0.57 (95% CI 0.37-0.89) P=0.012 HR=0.61 (95% CI 0.46-0.80) P<0.001

Hospitalizations in A-HeFT Mean follow-up of 10 months 86 patients died 423 (40.3%) had at least one hospitalization 221 (41.5%) in placebo 202 (39%) in the BiDil groups.

Baseline Characteristics By Hospitalization Never Hospitalized (N=627) Hospitalized at least once (N=423) P Age, mean (SD) 56.6 (12.7) 57.0 (13.5) 0.618 Male % 60.3 59.6 0.817 LVEF, percent (SD) 24.5 (7.56) 23.3 (7.20) 0.016 Previous MI % 24.7 35.2 <0.001 Diabetes Mellitus % 37.8 45.4 0.014 COPD % 16.9 22.5 0.025 Atrial Fibrillation (%) 13.9 20.6 0.004 CKD % 14.5 21.3 0.004 BNP (pg/ml), mean (SD) 256 (356) 365 (452) <0.001 ACE-I % 74.0 76.1 0.437 ARB % 24.6 19.4 0.049 Beta Blocker % 85.5 79.2 0.008 Diuretic % 90.0 95.3 0.002

Recurrent Hospitalizations in A-HeFT Of the 423 patients with at least one hospitalization, there were 239 (57%) who had multiple hospitalizations: 136 in placebo and 103 in the FDC I/H group (Chi 2 p=0.029). In the 423 patients, there were a total of 993 all-cause hospitalizations 424 (43%) for heart failure 232 (23%) for other cardiac causes 337 (34%) were non-cardiac.

Why Should we Study Recurrent Hospitalizations Time-to-First event analyses ignore a vast amount of information on patient outcomes in a condition such as HF While death is important to the patient, hospitalizations may be even more important because they are associated with worse QoL. Analysis of total or recurrent hospitalizations assesses the total burden of the disease to the patient and the society Use of recurrent hospitalizations as an endpoint may increase statistical power in a randomized control trial, decrease sample size, and reduce cost of the study

All-Cause Hospitalizations in A-HeFT All Cause Hospitalizations All Placebo FDC I/H Patients Total number of hospitalizations 993 558 435 Events per 100 person-years 89 101 77 Patients with 1 or more hospitalizations 423 221 202 Patients with 2 or more hospitalizations 239 136 103 Total days spent in hospital 5514 3323 2191 Mean duration of hospitalization (days) 5.55 5.96 5.04

Hospitalization for HF in A-HeFT Heart Failure Hospitalizations All Placebo FDC I/H Patients Number of hospitalizations 424 251 173 Events per 100 person-years 37.9 45.4 30.5 Patients with 1 or more hospitalizations 215 130 85 Patients with 2 or more hospitalizations 102 61 41 Total days spent in hospital 2739 1745 994 Mean duration of hospitalization (days) 6.46 6.95 5.75

A-HeFT All all-cause and HF Hospitalizations All Patients Placebo FDC I/H Δ Number of patients 1050 532 518 Total follow-up time (years) 1119 553 567 All-Cause Hospitalizations Number (%) with 1 or more 423 (40.3) 221 (41.5) 202 (39) 2.5% Number (%) with 2 or more 239 (22.8) 136 (25.6) 103 (19.9) Total # of hospitalizations 993 558 435 Heart Failure Hospitalizations 123 (12.4%) Number (%) with 1 or more 215 (20.4) 130 (24.4) 85 (16.4) 8% Number (%) with 2 or more 102 (9.7) 61 (11.5) 41(7.9) Total # of hospitalizations 424 251 173 78 (18.4%) 63%

Difficulty in Interpreting Recurrent Hospitalizations Hospitalization and death are related to each other and are competing risks. Death removes the sickest patients who are more likely to be hospitalized, whereas a hospitalization increases the risk of death and the risk of subsequent hospitalization. Therefore, a difference in hospitalization rate between treatment groups could be due solely to differences in survival rather than a specific effect of the treatment on hospitalizations per se.

Difficulty in Interpreting Recurrent Hospitalizations When a drug or device reduces the risk of death, the risk of hospitalizations in that group is expected to increase because the sickest patients are still alive and at a higher risk of hospitalization. Thus, the treatment effect of the drug or device on hospitalizations will be attenuated, if adjustment are not made for the competing risk of death.

A-HeFT Cumulative First All-Cause and Heart Failure Hospitalization Fine Gray Competing-Risks Regression Model Takes Into Account Deaths As Competing Events HR 0.88 (0.72-1.06), p=0.18 HR 0.61 (0.47-08), p<0.001

A-HeFT Cumulative All all-cause and Heart Failure Hospitalization Joint Shared Frailty Regression Model Accounts for the correlation between recurrent events, as well as the correlation between the current process and death

A-HEFT All-cause and Cause-Specific Recurrent Hospitalizations Joint Shared Frailty Regression Model Accounts for the correlation between recurrent events, as well as the correlation between the current process and death Type of Hospitalization # with >1 Hospitalization # of Events per persons HR 95% CI P-Value All-cause hospitalization 423 / 1050 993 in 423 pts. 0.75 0.63 to 0.91 0.003 HF hospitalization 215 / 1050 424 in 215 pts. 0.66 0.52 to 0.83 0.0005 Other Cardiac hospitalizations 170 / 1050 232 in 170 pts. 0.81 0.65 to 1.01 0.06 Non-cardiac hospitalizations 226 / 1050 337 in 226 pts. 0.85 0.67 to 1.10 0.22

Effect of BiDil on Time to Hospital Readmission Type of Hospitalization FDC I/H Placebo P-value All-cause, adjusted 100 days 82 days 0.014 Heart Failure, adjusted 93 days 79 days 0.345 Other Cardiac, adjusted 119 days 108 days 0.105 Non-Cardiac, adjusted 158 days 145 days 0.670

30-day Readmission Rates After HF: Patients Aged 65 Years (2007-2009) Median 24.7%, Range: 17.0 33.0% Medicare Hospital Quality Chartbook 2011: Performance Report on Readmission Measures for Acute Myocardial Infarction, Heart Failure, and Pneumonia. September 15, 2011.

CMS Hospital Readmissions Reduction Program 2012-2013 Effective October 1, 2012 patients being discharges from hospitals for HF, MI, and pneumonia are being penalized and payments are being reduced based on the dollar value of the hospital's percentage of preventable Medicare readmissions for these 3 conditions Considerable interest in reducing the 30-day readmission rate

Risk Factors Associated with Rehospitalization Multiple independent factors Unclear which factors can be modified? Largely driven by patient and community-level factors often outside control of hospitals Only a small proportion of readmissions at 30 days are likely to be preventable* *Joynt KE, et al. NEJM. 2012;366(15):1366 1369.

Risk-adjusted Odds of 30-day Readmission for HF by Race Race African American # of patients All-cause Readmission rate (%) 149,758 24.8 Odds ratio (95% CI) 1.13 (1.10-1.16) Same-cause Readmission rate (%) 11.1 Odds ratio (95% CI) 1.11 (1.09-1.13) Caucasian 1,197,010 22.6 1.00* 10.2 1.00* *Reference value Joynt KE, et al. JAMA. 2011;305(7):675-681.

30-day Readmission Rates After HF: AA Patients Aged 65 Years (2007-2009) Medicare Hospital Quality Chartbook 2011: Performance Report on Readmission Measures for Acute Myoca Infarction, Heart Failure, and Pneumonia. September 15, 2011.

A-HeFT Risk of 30-day All-cause Readmission by Treatment Group After the First Heart Failure Hospitalization Type of Readmission # Patients FDC I/H No. with 1 30-day Adm Placebo No. with 1 30-day Adm Odds Ratio (95% CI) P All-cause 204 12/81 (14.8%) 29/123 (23.6%) 0.59 (0.30-1.16) 0.12

A-HeFT Risk of 30-day All-cause Readmission by Treatment Group After the First Heart Failure Hospitalization Type of Readmission # Patients FDC I/H No. with 1 30-day Adm Placebo No. with 1 30-day Adm Odds Ratio (95% CI) P All-cause 204 12/81 (14.8%) 29/123 (23.6%) 0.59 (0.30-1.16) 0.12 Compared with First All-cause 1050 202/423 (39%) 221/423 (41.5%) 0.88 (0.72-1.06) 0.18 All - All-cause 1050 435/993 (44%) 558/993 (56%) 0.75 (0.63-0.91 0.003

Summary The addition of BiDil to standard HF therapy significantly reduced the risk of all all-cause, all heart failure and had a borderline effect on other cardiac hospitalizations in A-HeFT when statistical methods designed to account for death and recurrent hospitalizations are used for the analyses. BiDil increased the time between hospital discharge and allcause readmission BiDil was associated with a 41% reduction in 30-day all-cause re-hospitalization rate, although this was not significant because of small sample size.