Zachary Binney

Association of Statin Dose With Amputation and Survival in Patients With Peripheral Artery Disease

Background: Statin dose guidelines for patients with peripheral artery disease (PAD) are largely based on coronary artery disease and stroke data. The aim of this study is to determine the effect of statin intensity on PAD outcomes of amputation and mortality. Methods: Using an observational cohort study design and a validated algorithm, we identified patients with incident PAD (2003–2014) in the national Veterans Affairs data. Highest statin intensity exposure (high-intensity versus low-to-moderate–intensity versus antiplatelet therapy but no statin use) was determined within 1 year of diagnosis of PAD. Outcomes of interest were lower extremity amputations and death. The association of statin intensity with incident amputation and mortality was assessed with Kaplan-Meier plots, Cox proportional hazards modeling, propensity score–matched analysis, and sensitivity and subgroup analyses, as well, to reduce confounding. Results: In 155 647 patients with incident PAD, more than a quarter (28%) were not on statins. Use of high-intensity statins was lowest in patients with PAD only (6.4%) in comparison with comorbid coronary/carotid disease (18.4%). Incident amputation and mortality risk declined significantly with any statin use in comparison with the antiplatelet therapy–only group. In adjusted Cox models, the high-intensity statin users were associated with lower amputation risk and mortality in comparison with antiplatelet therapy–only users (hazard ratio, 0.67; 95% confidence interval, 0.61–0.74 and hazard ratio, 0.74; 95% confidence interval, 0.70–0.77, respectively). Low-to-moderate–intensity statins also had significant reductions in the risk of amputation and mortality (hazard ratio amputation, 0.81; 95% confidence interval, 0.75– 0.86; hazard ratio death, 0.83; 95% confidence interval, 0.81–0.86) in comparison with no statins (antiplatelet therapy only), but effect size was significantly weaker than the high-intensity statins (P<0.001). The association of high-intensity statins with lower amputation and death risk remained significant and robust in propensity score–matched, sensitivity, and subgroup analyses. Conclusions: Statins, especially high-intensity formulations, are underused in patients with PAD. This is the first population-based study to show that high-intensity statin use at the time of PAD diagnosis is associated with a significant reduction in limb loss and mortality in comparison with low-to-moderate–intensity statin users, and patients treated only with antiplatelet medications but not with statins, as well.

Feasibility and economic impact of dedicated hospice inpatient units for terminally ill ICU patients.

Objectives:End-of-life care is frequently provided in the ICU because patients receiving life-sustaining treatments are often unsuitable for transfer to home or community hospices. In-hospital dedicated hospice inpatient units are a novel option. This study was designed to 1) demonstrate the feasibility of ICU to dedicated hospice inpatient unit transfer in critically ill terminal patients; 2) describe the clinical characteristics of those transferred and compare them to similar patients who were not transferred; and 3) assess the operational and economic impact of dedicated hospice inpatient units. Design:Retrospective chart review. Setting:ICUs and dedicated hospice inpatient units at two southeast urban university hospitals. Interventions:Charts of ICU and dedicated hospice inpatient unit deaths over a 6-month period were reviewed. Patients:Dedicated hospice inpatient unit transfers were identified from hospice administrator records. Missed opportunities were patients admitted to the hospital for more than 48 hours who either adopted a comfort care course or had a planned termination of life-sustaining therapy. Patients were excluded if they were declared brain dead, were organ donors, required high-frequency ventilation, or if there was insufficient information in the medical record to make a determination. Measurements and Main Results:We identified 167 transfers and 99 missed opportunities; 37% of appropriate patients were not transferred. Transfers were older (66.9 vs 60.4 yr; p < 0.05), less likely to use mechanical ventilation (71.9% vs 90.9%) and vasopressors (70.9% vs 95.0%; p < 0.05), and less likely to receive a palliative care consult (70.4% vs 43.4%; p < 0.05) than missed opportunities. Transfers saved 585 ICU bed days. Conclusions:Dedicated hospice inpatient units are a feasible way to provide care for terminal ICU patients, but barriers including lack of knowledge of the units and provider or family comfort with leaving the ICU remain. Dedicated hospice inpatient units are potentially significant sources of bed days and cost savings for hospitals and the healthcare system overall.

Prevalence, predictors, and outcomes of advance directives in implantable cardioverter-defibrillator recipients

BACKGROUND Little is known about advance directive (AD) utilization in implantable cardioverter-defibrillator (ICD) recipients. OBJECTIVE The purpose of this study was to define the prevalence and predictors of ADs in patients with ICDs. METHODS We identified ICD recipients with ADs at our institution. The primary end point was the prevalence of an AD documented up to 1 year after device implant and the secondary end point was the cumulative prevalence of an AD. RESULTS Of 2549 patients with ICDs, 701 (27.5%) were followed for at least 1 year after device implant, and of those 701 patients, 164 (23.4%) had ADs documented before or within 1 year of ICD implant. The prevalence of ICD recipients with ADs increased overtime, reaching approximately 10% in the most recent years of analysis. However, only 1 AD specifically addressed the ICD as part of end-of-life decision making. In multivariable analysis, more recent year of device implant and prior cardiovascular hospitalization were positively associated with having an AD within 1 year of implant. The cumulative prevalence of an AD at any time after implant reached about 30%, with more recent implant year, prior cardiovascular hospitalization, and palliative care consultation positively associated with the presence of an AD and black race associated with a lower cumulative prevalence. CONCLUSION In a tertiary academic medical center, most patients with ICDs still do not have ADs, and even when they do, the ICDs are rarely addressed as part of the directive. Several predictors of ADs emerged, which may provide opportunities to improve utilization of ADs in ICD recipients.

High Hemoglobin A1c Associated with Increased Adverse Limb Events in Peripheral Arterial Disease Patients Undergoing Revascularization

Objective Diabetes and peripheral arterial disease (PAD) are independently associated with increased risk of amputation. However, the effect of poor glycemic control on adverse limb events has not been studied. We examined the effects of poor glycemic control (high hemoglobin A1c level) on the risk of amputation and modified major adverse limb events (mMALEs) after lower extremity revascularization. Methods Patients undergoing PAD revascularization who had hemoglobin A1c (HbA1c) levels available within 6 months were identified in the Veterans Affairs database of 2003 to 2014 (N = 26,799). The diagnosis of preoperative diabetes mellitus (PreopDM) was defined using diabetes diagnosis codes and evidence of treatment. Amputation and mMALE risk was compared for HbA1c levels using Kaplan‐Meier analysis. Cox proportional hazards models were created to assess the effect of high HbA1c levels on amputation and mMALE (adjusted for age, gender, race, socioeconomic status, comorbidities, cholesterol levels, creatinine concentration, suprainguinal or infrainguinal procedure, open or endovascular procedure, severity of PAD, year of cohort entry, and medications) for all patients and stratified by PreopDM. Results High HbA1c levels were present in 33.2% of the cohort, whereas 59.9% had PreopDM. Amputations occurred in 4359 (16.3%) patients, and 10,580 (39.5%) had mMALE. Kaplan‐Meier curves showed the worst outcomes in patient with PreopDM and high HbA1c levels. In the Cox model, incremental HbA1c levels of 6.1% to 7.0%, 7.1% to 8.0%, and >8% were associated with 26% (hazard ratio [HR], 1.26; 95% confidence interval [CI], 1.15‐1.39), 53% (HR, 1.53; 95% CI, 1.37‐1.7), and 105% (HR, 2.05; 95% CI, 1.87‐2.26) higher risk of amputation, respectively. Similarly, the risk of mMALE also increased by 5% (HR, 1.05; 95% CI, 0.99‐1.11), 21% (HR, 1.21; 95% CI, 1.13‐1.29), and 33% (HR, 1.33, 95% CI, 1.25‐1.42) with worsening HbA1c levels of 6.1% to 7.0%, 7.1% to 8.0%, and >8%, respectively (vs HbA1c ≤6.0%). In stratified analysis by established PreopDM, the relative risk of amputation or mMALE was much higher with poor glycemic control (HbA1c >7.0%) in patients without PreopDM. Conclusions PAD patients with worse perioperative glycemic control have a significantly higher risk of amputation and mMALE. Incremental increases in HbA1c levels are associated with higher hazards of adverse limb outcomes independent of PreopDM status. Poor glycemic control (HbA1c >7.0%) in patients without a PreopDM diagnosis carries twice the relative risk of amputation and mMALE than in those with good glycemic control. These results suggest that screening of diabetic status and better management of glycemic control could be a target for improvement of perioperative and long‐term outcomes in PAD patients.

The association of comorbid depression with mortality and amputation in veterans with peripheral artery disease

Objective: Peripheral artery disease (PAD) is an increasing health concern with rising incidence globally. Previous studies have shown an association between PAD incidence and depression. The objective of the study was to determine the association of comorbid depression with PAD outcomes (amputation and all‐cause mortality rates) in veterans. Methods: An observational retrospective cohort of 155,647 patients with incident PAD (2003‐2014) from nationwide U.S. Veterans Health Administration hospitals was conducted using the national Veterans Affairs Corporate Data Warehouse. Depression was measured using concurrent International Classification of Diseases, Ninth Revision diagnosis codes 6 months before or after PAD diagnosis. The main outcomes were incident major amputation and all‐cause mortality. Crude associations were assessed with Kaplan‐Meier plots. The effects of depression adjusted for covariates were analyzed using Cox proportional hazards models. Results: Depression was present in 16% of the cohort, with the occurrence of 9517 amputations and 63,287 deaths (median follow‐up, 5.9 years). Unadjusted hazard ratios (HRs) of comorbid depression for amputations and all‐cause mortality were 1.32 (95% confidence interval [CI], 1.25‐1.39) and 1.02 (95% CI, 0.99‐1.04), respectively. After adjustment for covariates in Cox regression models, a diagnosis of comorbid depression at the time of PAD diagnosis was associated with a 13% higher amputation (HR, 1.13; 95% CI, 1.07‐1.19) and 17% higher mortality (HR, 1.17; 95% CI, 1.14‐1.20) risk compared with patients with no depression. On stratification by use of antidepressants, depressed patients not taking antidepressants had a 42% higher risk of amputation (HR, 1.42; 95% CI, 1.27‐1.58) compared with those without depression. Patients taking antidepressants for depression still had increased risk of amputation but only 10% higher compared with those without depression (HR, 1.10; 95% CI, 1.03‐1.17). Interestingly, patients taking antidepressants for other indications also had a higher risk of amputation compared with those not having depression or not taking antidepressants (HR, 1.08; 95% CI, 1.03‐1.14). Having any diagnosis of depression or the need for antidepressants increased the mortality risk by 18% to 25% in the PAD cohort compared with those without depression and not taking antidepressants for any other indication. Conclusions: PAD patients with comorbid depression have a significantly higher risk of amputation and mortality than PAD patients without depression. Furthermore, untreated depression was associated with an increased amputation risk in the PAD population, more so than depression or other mental illness being treated by antidepressants. The underlying mechanisms for causality, if any, remain to be determined. The association of antidepressant treatment use with amputation risk should prompt further investigations into possible mechanistic links between untreated depression and vascular dysfunction.

Race and Socioeconomic Status Independently Affect Risk of Major Amputation in Peripheral Artery Disease

Background Black race has been shown to be a risk factor for amputation in peripheral artery disease (PAD); however, race has been argued to be a marker for socioeconomic status (SES) rather than true disparity. The aim of this study is to study the impact of race and SES on amputation risk in PAD patients. Methods and Results Patients with incident PAD in the national Veterans Affairs Corporate Data Warehouse were identified from 2003 to 2014 (N=155 647). The exposures were race and SES (measured by median income in residential ZIP codes). The outcome was incident major amputation. Black veterans were significantly more likely to live in low‐SES neighborhoods and to present with advanced PAD. Black patients had a higher amputation risk in each SES stratum compared with white patients. In Cox models (adjusting for covariates), black race was associated with a 37% higher amputation risk compared with white race (hazard ratio: 1.37; 95% confidence interval, 1.30–1.45), whereas low SES was independently predictive of increased risk of amputation (hazard ratio: 1.12; 95% confidence interval, 1.06–1.17) and showed no evidence of interaction with race. In predicted amputation risk analysis, black race and low SES continued to be significant risk factors for amputation regardless of PAD presentation. Conclusions Black race significantly increases the risk of amputation within the same SES stratum compared with white race and has an independent effect on limb loss after controlling for comorbidities, severity of PAD at presentation, and use of medications.

Impact of Consultation Triggers on Streamlining Palliative Care Interventions (TH310A)

Objectives Review results from the June 2015 Clinical & Research Priorities for Heart Failure and Palliative Care National Symposium of cardiology and palliative experts (funded by the John A. Hartford Foundation, American Federation for Aging Research, National Palliative Care Research Center, University of Alabama-Birmingham, and Icahn School of Medicine at Mount Sinai), which focused on the barriers to and opportunities for improving palliative care integration among patients with advanced cardiac disease. Discuss opportunities and strategies for collaboration of palliative care and heart failure within the domains of research, clinical care, and policy change. Identify two specific implementation projects to improve care for patients with advanced heart failure within each area of research, clinical programs, and policy. Hospital readmission rates, mortality rates, and Medicare costs for patients with heart failure (HF) are high. Patients with HF are burdened by multiple symptoms that increase as the disease progresses. Because HF carries a substantial burden, it is critical to understand how palliative care can contribute to improving the quality of care for this population. Yet, the evidence base demonstrating the benefits of palliative care on outcomes and quality of care in patients with HF is still lacking. Change can only happen with an interdisciplinary, explicit strategic change approach. We conducted a series of telephonic nominal groups followed by a 2-day in-person symposium, which pulled together a group of interdisciplinary, nationally-recognized clinicians, investigators, and policy experts representing HF, geriatrics, and palliative care to address the following 3 questions: 1) What are the greatest challenges and barriers faced in HF regarding the integration of palliative care? 2) What are the state of the science and gaps in knowledge regarding patients with advanced HF and their family caregivers? 3) What are the most successful care models or strategies that are currently making a difference in HF care? The purpose of this concurrent session is to 1) describe themethods we used to develop consensus of strategies for each of these domains and 2) detail symposium results and achievements. The overall goal is to build support for a national agenda to advance the field of palliative care for patients withHF and their family caregivers. Specifically, we will review proposed research, clinical demonstration projects, national guidelines, and policy to develop priorities for implementation and endorsement.Wewill also describe and solicit additional input to create sustainable working groups that can formulate research, policy, and practice priorities andpotential opportunities for collaboration and funding in order to develop a sustainable model for future collaboration.

Derivation and validation of a risk model for emergency department palliative care needs assessment using the Screen for Palliative and End-of-Life Care Needs in the Emergency Department (SPEED).

22 Background: A key setting for the provision of palliative care is the emergency department (ED) where important decisions regarding treatment and next site of care are determined; however identifying patients who would benefit from a palliative care consult is an ongoing challenge. The (SPEED) is a 5-question tool that assesses unmet palliative care needs. METHODS We performed a retrospective derivation and temporal validation of a risk model for a palliative care event (PCE) among cancer patients with an ED visit and subsequent hospital admission using data available upon arrival, including data from the SPEED tool. A PCE was defined as a palliative care consult, discharge to hospice, or in-hospital death. We developed a multivariate logistic regression model to predict PCEs. We assessed model performance using a receiver operating characteristic curve and visual inspection of quintile plots. RESULTS Eleven factors were identified as predictive of a PCE, including SPEED score, proxy SPEED informer, age, EMS arrival, emergent or immediate ED acuity, the number of ED visits within the last 90 days, metastatic cancer, cardiac arrhythmias, coagulopathy, depression and weight loss. In validation, the risk model had an area under the curve of 0.72 and calibration showed an underestimation of risk in the second and third quintiles. CONCLUSIONS A risk model based on SPEED score has been successfully derived, but needs a larger dataset for proper validation. If the predictive ability of the model is confirmed, a risk model can efficiently identify cancer patients arriving to the ED who may benefit from early initiation of a palliative care consult.