An early heart failure follow-up intervention succeeded in increasing referral to and completion of cardiology appointments within 7 days of discharge. The intervention was associated with lower risk of 30-day all-cause emergency department visits, all-cause hospitalizations, or death.
Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive, fatal condition characterized by worsening heart failure (HF), exercise intolerance, cardiac arrhythmias, aortic stenosis, and orthopedic manifestations. Recent analyses have shown ATTR-CM presents a significant burden to the healthcare system, but data on healthcare resource utilization (HCRU) comparing ATTR-CM to non-ATTR HF in the US are lacking. Aim: To compare HCRU and costs in patients (pts) with ATTR-CM to that of pts with non-ATTR HF using medical and pharmacy claims. Methods: Using the Optum Clinformatics Data Mart (Jan 2016-Sep 2023), pts with ATTR-CM were identified based on presence of HF and/or cardiomyopathy (CM) occurring within 2 years of first amyloidosis diagnosis (excluding light-chain amyloidosis) and followed for at least 12 months after first HF/CM diagnosis. ATTR-CM pts were matched 1:1 to non-ATTR HF pts using propensity score matching. After index diagnosis, both groups were assessed for HCRU, including inpatient acute cardiovascular (CV) hospitalizations (CVH), length of stay, and cost. Hospitalizations were considered CV if a pt received a CV diagnosis during the hospitalization period. Results: There were 4581 pts with ATTR-CM (mean [±SD] age: 76 [9.13] years; 56.2% male) who met inclusion criteria and were matched to 4581 non-ATTR HF pts (mean [±SD] age: 76 [8.86] years; 56.0% male) for comparison (Table). ATTR-CM pts had a higher trend of CVH and a higher number of total CVHs and mean hospitalizations per pt compared to non-ATTR HF pts (p<0.001). The mean cost per hospitalization (p=0.00463) and mean cost per annual hospitalizations per pt (p<0.001) were higher for ATTR-CM compared to non-ATTR HF. ATTR-CM pts were also hospitalized for more mean days annually for CV-related reasons compared to non-ATTR HF pts (p<0.001). On average, pts with ATTR-CM spent 2.3 days more than matched non-ATTR HF pts in the hospital each year. Conclusion: Compared to non-ATTR HF, ATTR-CM is associated with a greater burden on the healthcare system as evaluated by hospitalization rate, costs per hospitalization, annual hospitalization costs, and days hospitalized annually.
OBJECTIVE To determine the intra‐individual (physiological) variation of prostate‐specific antigen (PSA) measurements in men after a benign prostatic biopsy. PATIENTS AND METHODS Sixty‐four men were prospectively assessed, all of whom had a benign prostatic biopsy within the preceding 13 months. The degree of intra‐individual variability was established by calculating the coefficient of variation on four PSA levels obtained from each patient weekly over a month. RESULTS Six patients were subsequently diagnosed with prostate cancer and their data are presented separately. In the remaining 58 patients the median (range) individual mean PSA value was 6.3 (0.5–34.1) ng/mL. The median (range) coefficient of variation within the group was 9.5 (2.4–76.1)%. There was a clear linear relationship between mean PSA level and the standard deviation. CONCLUSION In 48 of the 63 patients analysed, the coefficient of variation for serum PSA values in the group as a whole was greater than the variation claimed for the assay technique. The significance of the linear relationship between PSA and the standard deviation is discussed, with particular reference to those men who had a benign prostate biopsy.
Objective: The literature has demonstrated that patient self-care behaviors in heart failure (HF) and health system factors play an important role in patients’ health status and hospitalization risk. Utilizing the Chronic Care Model, shared medical appointments (SMA) are a type of care delivery redesign that provides patient self-management and peer support in addition to clinician-led disease management. In this model, the SMA team consists of a nutritionist, cardiology nurse, health psychologist, and a non-physician prescribing provider. The session begins with an assessment of patient needs followed by pre-assigned theme-based education and individualized medication management. Methods and Expected Results: At two VA medical centers, we will randomize 375 patients within 6 weeks of discharge from a HF hospitalization to receive either SMA intervention (4 sessions over 8 weeks) versus usual care (individual provider appointments) for HF. Inclusion criteria are: not enrolled in other programs for HF care, <2 hospitalizations last 6 months, left ventricular ejection fraction <40%. We will use stratified block randomization with block sizes of 4 at each site to ensure balance of the stratified variables. At 180 days, we will determine whether HF patients who participate in HF-SMA, as compared to patients who receive usual care: 1) Experience better cardiac health status measured by Kansas City Cardiomyopathy Questionnaire (primary outcome), and overall health status (EQ5D, secondary outcome); 2) Have fewer hospitalization or death and 3) Experience improvement in intermediate outcomes: a) increase in HF Self-Care Index, and b) decrease in plasma BNP levels. For patients who underwent HF-SMA, we will also determine perceived benefits, areas in need of improvement, potential obstacles of implementation, and fidelity of the intervention across sites, by conducting (a) face-to-face interviews with patients and (b) telephone interviews with physicians and administrators. Using VA cost data, we will perform a cost-effectiveness analysis to inform future VA resource allocation. Conclusions: This trial will generate critical knowledge regarding the clinical and cost-effectiveness of SMA in HF patients to provide patient-centered care, improve health status, and reduce readmission for patients with HF. Further, the results of the formative evaluation will support future implementation of this novel intervention into routine clinical practice.
The safety, effectiveness and indications for ultrafiltration (UF) are not well established. We hypothesized that UF would not worsen renal function in patients with heart failure (HF) who were not responding to medical therapy.Data was collected for patients who underwent UF between 2006 and 2010 (n = 72, median age 61 years, 54% males, 61% Caucasian, 54% left ventricular ejection fraction ≥ 40%).Baseline GFR was 38 ml/min/1.73 m2. All patients were initially treated with loop diuretics and 58% required a thiazide-like diuretic or vasoactive agent. UF resulted in total fluid removal of 11.3 liters and weight loss was 9.7 kg. The median decrease in eGFR during UF was 4.5 ml/min/m2 (IQR--13, 0; p < 0.01) and 43% of patients experienced a ≥ 20% decrease in eGFR. Ten percent of patients required dialysis and 13% died, received a ventricular assist device/cardiac transplant or were discharged to hospice.In a cohort of HF patients who did not respond to medical therapy, UF was associated not only with a significant reduction of body weight and fluid removal, but also acute worsening of renal function. Further research to identify the appropriate population for UF, long-term outcomes and the intensity of treatment is required if UF is to gain wide acceptance for HF management.
Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) is estimated to occur in 120,000 US adults and remains underdiagnosed. However, awareness of ATTR-CM has improved following the introduction of new diagnostic tools and disease-modifying treatments. Hence, patients (pts) enrolled in contemporary clinical trials could be at an earlier stage of the disease than pts in past clinical studies. Aim: To assess temporal trends in the baseline risk of pts with ATTR-CM enrolled in clinical trials. Methods: Embase, MEDLINE, CENTRAL, and conference websites were searched on November 23, 2023, for peer-reviewed articles and abstracts. Randomized and single-arm clinical trials examining treatments for ATTR-CM were included, and baseline characteristics and outcomes in pts treated with placebo (PBO) were compared across studies. Results: We reviewed 39 publications derived from 4 randomized and 4 single-arm trials. Studies enrolled pts between 2008 and 2021, although 1 study (INOCARD, 2022) did not report years of enrollment. Several baseline characteristics were comparable across studies, including sex, age, race/ethnicity, genotype, and troponin I level. NYHA class at baseline varied with year of enrollment, with fewer NYHA class III pts in recent trials (Figure). Recent trials also showed a trend toward lower NT-proBNP levels (medians ranging from 1911-3178 pg/mL) and higher eGFR levels (means ranging from 54.7-69.0 mL/min/1.73 m 2 ). In PBO groups, all-cause mortality (ACM) rates at 12 months dropped from 9% in ATTR-ACT (enrolled 2013-2015) to 6.9% in ATTRibute-CM (enrolled 2019-2020) and 5.6% in APOLLO-B (enrolled 2019-2021); ACM rates at 30 months dropped from 42.9% in ATTR-ACT to 25.7% in ATTRibute-CM. Conclusions: This systematic review found that disease-modifying treatments and diagnostic advances have led to earlier diagnosis of pts with ATTR-CM. Recent clinical trials appear to have enrolled pts with a better prognosis. Comparisons of results across these trials are limited and should acknowledge the potential impact of variability in baseline risks among trial populations.
