Sandesh Dev

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.

IMPORTANCE For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy. OBJECTIVE To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting. DESIGN, SETTING, AND PARTICIPANTS This was a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach. INTERVENTIONS Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins. MAIN OUTCOMES AND MEASURES Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings. RESULTS A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90% CI, -3.5% to 10.5%; P=.36) and did not meet the noninferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P=.04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were

“Not the ‘Grim Reaper Service’”: An Assessment of Provider Knowledge, Attitudes, and Perceptions Regarding Palliative Care Referral Barriers in Heart Failure

3.37 per day and

Comparing Unmet Needs between Community-Based Palliative Care Patients with Heart Failure and Patients with Cancer

716 per patient. CONCLUSIONS AND RELEVANCE This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01415934.

Reduction in Body Weight but Worsening Renal Function with Late Ultrafiltration for Treatment of Acute Decompensated Heart Failure

Background Although similar to cancer patients regarding symptom burden and prognosis, patients with heart failure (HF) tend to receive palliative care far less frequently. We sought to explore factors perceived by cardiology, primary care, and palliative care providers to impede palliative care referral for HF patients. Methods and Results We conducted semistructured interviews regarding (1) perceived needs of patients with advanced HF; (2) knowledge, attitudes, and experiences with specialist palliative care; (3) perceived indications for and optimal timing of palliative care referral in HF; and (4) perceived barriers to palliative care referral. Two investigators analyzed data using template analysis, a qualitative technique. We interviewed 18 physician, nurse practitioner, and physician assistant providers from 3 specialties: cardiology, primary care, and palliative care. Providers had limited knowledge regarding what palliative care is, and how it can complement traditional HF therapy to decrease HF‐related suffering. Interviews identified several potential barriers: the unpredictable course of HF; lack of clear referral triggers across the HF trajectory; and ambiguity regarding what differentiates standard HF therapy from palliative care. Nevertheless, providers expressed interest for integrating palliative care into traditional HF care, but were unsure of how to initiate collaboration. Conclusions Palliative care referral for HF patients may be suboptimal due to limited provider knowledge and misperceptions of palliative care as a service reserved for those near death. These factors represent potentially modifiable targets for provider education, which may help to improve palliative care referral for HF patients with unresolved disease‐related burden.

Temporal Trends and Hospital Variation in Mineralocorticoid Receptor Antagonist Use in Veterans Discharged With Heart Failure

BACKGROUND As the role of palliative care (PC) has yet to be clearly defined in patients with heart failure (HF), such patients may face barriers regarding PC referral. In order to maximally meet the needs of HF patients, it is necessary to understand how they compare to the classic PC population: patients with cancer. OBJECTIVE To characterize the unresolved symptom and treatment needs with which patients with HF and those with cancer present to PC. METHODS We used data from the Palliative Care Research Registry (PCRR), a repository of quality improvement data from three community-based PC organizations. We abstracted first PC visit data from the PCRR for patients with primary diagnoses of HF or cancer seen between 2008 and 2012. We assessed the association of primary diagnosis (i.e., HF or cancer) on three outcomes: unresolved symptoms, treatment gaps, and a composite indicator of symptom control and quality of life. Analyses included descriptive statistics and multivariate Poisson regression. RESULTS Our analytic sample comprised 334 patients with HF and 697 patients with cancer, the majority of whom were white and male. Compared to patients with cancer, patients with HF presented with fewer unresolved symptoms, both overall and at moderate/severe distress levels. Patients with HF more commonly reported moderately/severely distressful dyspnea (25% versus 18%, p=0.02), and more commonly experienced dyspnea-related treatment gaps (17% versus 8%, p<0.001). CONCLUSIONS Patients with HF possess care needs that are squarely within the purview of PC. Future work is needed to delineate how PC referral policies should be refined to optimize PC access for patients with HF.

Prevalence, correlates, and temporal trends in antiarrhythmic drug use at discharge after implantable cardioverter defibrillator placement (from the National Cardiovascular Data Registry [NCDR]).

Objectives: 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. Methods: 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%). Results: 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. Conclusions: 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.

Barriers to adoption of mineralocorticoid receptor antagonists in patients with heart failure: A mixed-methods study

Background Despite concerns about mineralocorticoid receptor antagonist therapies (MRAs) underuse and misuse in patients with heart failure, temporal and institutional variations of MRA prescription have not been reported. Methods and Results We studied a national sample of veterans hospitalized for heart failure between 2003 and 2009 and left ventricular ejection fraction <40%. We identified ideal and non‐ideal candidates for MRA therapy based on American College of Cardiology/American Heart Association guidelines. We measured temporal trends and hospital variation of MRA prescriptions within 90 days after discharge. We determined the median odds ratio (MOR), a measure of the relative odds of an MRA prescription for 2 individuals with similar characteristics discharged at 2 randomly selected hospitals. From 37 126 patients (n=131 hospitals), 9355 were ideal‐MRA candidates, and 4056 were non‐ideal candidates. Among ideal candidates, 36% received an MRA, but there was a decline in use (41% in 2003 to 31% in 2009, P<0.001). Of non‐ideal candidates, 27% received an MRA with a decline in use (34% in 2003 to 22% in 2009, P<0.001). Hospital MRA prescription ranged from 0% to 71% for ideal candidates and 0% to 100% for non‐ideal candidates. The median odds ratios of MRA prescription for ideal and non‐ideal candidates were 1.44 and 1.36, respectively; a median odds ratio >1.2 indicates significant practice‐level variation. Conclusions There was decreasing MRA use between 2003 and 2009 with wide institutional variation in MRA prescription, which suggests opportunities for improvement to stimulate MRA use in ideal candidates while further reducing use in those with contraindications.

Group medical visits after heart failure hospitalization: Study protocol for a randomized-controlled trial

Patients with implantable cardioverter defibrillators (ICDs) can require antiarrhythmic drugs to manage arrhythmias and prevent device shocks. We sought to determine the prevalence, clinical correlates, and institutional variation in the use of antiarrhythmic drugs over time after ICD implantation. From the ICD Registry (2006 to 2011), we analyzed the trends in the use of antiarrhythmic agents prescribed at hospital discharge for patients undergoing first-time ICD placement. The patient, provider, and facility level variables associated with antiarrhythmic use were determined using multivariate logistic regression models. A median odds ratio was calculated to assess the hospital-level variation in the use of antiarrhythmic drugs. Of the cohort (n = 500,995), 15% had received an antiarrhythmic drug at discharge. The use of class III agents increased modestly (13.9% to 14.9%, p <0.01). Amiodarone was the most commonly prescribed drug (82%) followed by sotalol (10%). Among the subgroups, the greatest increase in prescribing was for patients who had received a secondary prevention ICD (26% in 2006% and 30% in 2011, p <0.01) or with a history of ventricular tachycardia (23% to 27%, p <0.01). The median odds ratio for antiarrhythmic prescription was 1.45, indicating that 2 randomly selected hospitals would have had a 45% difference in the odds of treating identical patients with an antiarrhythmic drug. In conclusion, antiarrhythmic drug use, particularly class III antiarrhythmic drugs, is common among ICD recipients at hospital discharge and varies by hospital, suggesting an influence from local treatment patterns. The observed hospital variation suggests a role for augmentation of clinical guidelines regarding the use of antiarrhythmic drugs for patients undergoing implantation of an ICD.

A Description of Patient and Provider Experience and Clinical Outcomes After Heart Failure Shared Medical Appointment

Background Mineralocorticoid receptor antagonists (MRAs) are the most underutilized pharmacotherapy for heart failure. Minimal data are available on the barriers to MRA adoption from the perspective of prescribing clinicians. Methods and Results A mixed‐methods study consisting of a survey (n=50), focus groups (n=39), interviews (n=6) with clinicians at a single US Department of Veterans Affairs medical center served to ascertain barriers to optimal use of MRAs. Participants were drawn from 6 groups: cardiology providers, cardiology fellows, hospitalists, clinical pharmacists, internal medicine residents, and primary care providers. Qualitative data were iteratively coded with qualitative data analysis software. The survey response rate was 17.3%. Overall, 51% of survey respondents were unfamiliar with eplerenone, and 6% were unfamiliar with spironolactone. In addition, 30% of respondents reported that they would order a laboratory test >2 weeks after a new MRA prescription, although that is beyond the guideline recommendation. Most providers correctly identified New York Heart Association class 3 and 4 patients as MRA eligible, but only 42% identified class 2 patients as MRA eligible. Through analysis of focus groups, we identified 8 barriers to MRA use in 3 categories: patient‐based barriers (concerns about polypharmacy and comorbidities, adverse effects, perceived patient nonadherence), provider‐based barriers (unclear roles and responsibilities, coordination and transitions of care, lack of experience or familiarity with MRAs), and system‐based barriers (system overload and provider time constraints, lack of systematic follow‐up procedures). Conclusions Eight primary barriers to MRA adoption at the provider, patient, and health system levels were identified from the prescriber perspective. These barriers can inform the creation of multilevel interventions that will be required to close the gap in MRA adoption.

Preferences of people with advanced heart failure—a structured narrative literature review to inform decision making in the palliative care setting

A primary goal of this research project is to better understand how shared medical appointments (SMAs) can improve the health status and decrease hospitalization and death for patients recently discharged with heart failure (HF) by providing education, disease state monitoring, medication titration, and social support to patients and their caregivers. We propose a 3-site randomized-controlled efficacy trial with mixed methods to test a SMA intervention, versus usual care. Patients within 12 weeks of a HF hospitalization will be randomized to receive either HF-SMA (intervention arm) with optional co-participation with their caregivers, versus usual care (control arm). The HF-SMA will be provided by a non-physician team composed of a nurse, a nutritionist, a health psychologist, a nurse practitioner and/or a clinical pharmacist and will consist of four sessions of 2-h duration that occur every other week for 8 weeks. Each session will start with an assessment of patient needs followed by theme-based disease self-management education, followed by patient-initiated disease management discussion, and conclude with break-out sessions of individualized disease monitoring and medication case management. The study duration will be 180 days for all patients from the day of randomization. The primary study hypothesis is that, compared with usual care, patients randomized to HF-SMA will experience better cardiac health status at 90 and 180 days follow-up. The secondary hypotheses are that, compared to usual care, patients randomized to HF-SMA will experience better overall health status, a combined endpoint of hospitalization and death, better HF self-care behavior, and lower B-type natriuretic peptide levels.