Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction
Conditions
Brief summary
This was a retrospective observational cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims. The main goal of the study was to compare home-time in Medicare FFS patients with heart failure with mildly reduced or preserved ejection fraction discharged with sacubitril/valsartan versus those discharged without sacubitril/valsartan.
Interventions
None listed
Sponsors
Novartis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized for heart failure from 01 January 2016 to 30 September 2021. * Were discharged alive (any discharge disposition other than Expired). * Had Mildly reduced or preserved ejection fraction (41% to 60%). * Had non-missing record of SAC/VAL use at discharge. * Continuously enrolled in Medicare Part A & B for the 12 months following the index HF hospitalization discharge date or until death.
Exclusion criteria
* Patients who left against medical advice (AMA), were transferred to an acute care facility, or discharged to hospice care. * Patients who had dialysis as an in-hospital procedure. * Patients with a medical history of chronic dialysis. * Patients with an in-hospital procedure of heart transplantation. * Patients with a medical history of heart transplantation. * Patients with an in-hospital procedure of left ventricular assist device. * Patients with a medical history of left ventricular assist device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status | Post-discharge at Day 30 | Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. |
| Time Spent 90 Days Post-discharge by Discharge SAC/VAL Prescription Status | Post-discharge at Day 90 | Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. |
| Time Spent 180 Days Post-discharge by Discharge SAC/VAL Prescription Status | Post-discharge at Day 180 | Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. |
| Time Spent 365 Days Post-discharge by Discharge SAC/VAL Prescription Status | Post-discharge at Day 365 | Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | — |
| Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation. |
| Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification \[ICD-10-CM\] diagnosis codes I098.1, I50.\*, I11.0, I13.0, I13.2) excluding transfers. |
| Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification \[ICD-10-CM\] diagnosis codes I098.1, I50.\*, I11.0, I13.0, I13.2) excluding transfers. |
| Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription | Post-discharge at Day 365 | Hospitalization for dialysis or end-stage kidney disease was defined as any inpatient claim having a primary diagnosis of dialysis or end-stage kidney disease (International Classification of Diseases, 10th revision, Clinical Modification \[ICD-10-CM\] diagnosis codes Z99.2, Z49, N18.5, N18.6; or ICD.9 - 585.6, V45.11, V56.0, V56.8) |
| Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription | Post-discharge at Day 365 | Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641. |
| Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription | Post-discharge at Day 365 | Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0. |
| Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription | Post-discharge at Day 365 | Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur. |
| Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. |
| Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | — |
| Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation. |
| Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | — |
| Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | — |
| Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Day 365 | Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641. |
| Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Day 365 | Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0. |
| Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Day 365 | Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur. |
| Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status | Post-discharge at Day 365 | SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. |
| Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status | Post-discharge at Day 365 | SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. |
| All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status | Post-discharge at Day 365 | SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. |
| All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status | Post-discharge at Day 365 | SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription. |
| Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | Composite measure: all-cause mortality or heart failure hospitalization. |
| Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription | Post-discharge at Days 30, 90, 180, and 365 | — |
| Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | — |
| Number of All-cause Mortality or Heart Failure (HF) Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription | Post-discharge at Days 30, 90, 180, and 365 | — |
Countries
United States
Outcome results
None listed