Cardiovascular Outcomes of α-Blockers vs 5-α Reductase Inhibitors for Benign Prostatic Hyperplasia.

Importance: The most prescribed class of medications for benign prostatic hyperplasia (BPH) is α-blockers (ABs). However, the cardiovascular safety profile of these medications among patients with BPH is not well understood. Objective: To compare the safety of ABs vs 5-α reductase inhibitors (5-ARIs) for risk of adverse cardiovascular outcomes. Design, Setting, and Participants: This active comparator, new-user cohort study was conducted using insurance claims data from a 20% random sample of Medicare beneficiaries from 2007 to 2019 to evaluate the 1-year risk of adverse cardiovascular outcomes. Males aged 66 to 90 years were indexed into the cohort at new use of an AB or 5-ARI. Twelve months of continuous enrollment and at least 1 diagnosis code for BPH within 12 months prior to initiation were required. Data were analyzed from January 2007 through December 2019. Exposures: Exposure was defined by a qualifying prescription fill for an AB or 5-ARI after at least 12 months without a prescription for these drug classes. Main Outcomes and Measures: Follow-up began at a qualified refill for the study drug. Primary study outcomes were hospitalization for heart failure (HF), composite major adverse cardiovascular events (MACE; hospitalization for stroke, myocardial infarction, or death), composite MACE or hospitalization for HF, and death. Inverse probability of treatment and censoring-weighted 1-year risks, risk ratios (RRs), and risk differences (RDs) were estimated for each outcome. Results: Among 189 868 older adult males, there were 163 829 patients initiating ABs (mean [SD] age, 74.6 [6.2] years; 579 American Indian or Alaska Native [0.4%], 5890 Asian or Pacific Islander [3.6%], 9179 Black [5.6%], 10 610 Hispanic [6.5%], and 133 510 non-Hispanic White [81.5%]) and 26 039 patients initiating 5-ARIs (mean [SD] age, 75.3 [6.4] years; 76 American Indian or Alaska Native [0.3%], 827 Asian or Pacific Islander [3.2%], 1339 Black [5.1%], 1656 Hispanic [6.4%], and 21 605 non-Hispanic White [83.0%]). ABs compared with 5-ARIs were associated with an increased 1-year risk of MACE (8.95% [95% CI, 8.81%-9.09%] vs 8.32% [95% CI, 7.92%-8.72%]; RR = 1.08 [95% CI, 1.02-1.13]; RD per 1000 individuals = 6.26 [95% CI, 2.15-10.37]), composite MACE and HF (RR = 1.07; [95% CI, 1.03-1.12]; RD per 1000 individuals = 7.40 [95% CI, 2.88-11.93 ]), and death (RR = 1.07; [95% CI, 1.01-1.14]; RD per 1000 individuals = 3.85 [95% CI, 0.40-7.29]). There was no difference in risk for HF hospitalization alone. Conclusions and Relevance: These results suggest that ABs may be associated with an increased risk of adverse cardiovascular outcomes compared with 5-ARIs. If replicated with more detailed confounder data, these results may have important public health implications given these medications' widespread use.

Practical guidance on the use of sacubitril/valsartan for heart failure.

Sacubitril/valsartan is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that has been recommended in clinical practice guidelines to reduce morbidity and mortality in patients with chronic, symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). This review provides an overview of ARNI therapy, proposes strategies to improve the implementation of sacubitril/valsartan in clinical practice, and provides clinicians with evidence-based, practical guidance on the use of sacubitril/valsartan in patients with HFrEF. Despite evidence demonstrating the benefits of ARNI therapy over standard of care, only a fraction of eligible patients takes sacubitril/valsartan. Barriers preventing the prescription of sacubitril/valsartan in eligible patients may include practitioners' unfamiliarity with ARNIs, safety concerns, and payer reimbursement issues. The optimal implementation of sacubitril/valsartan in clinical practice has the potential to reduce the overall burden of HF. Throughout this review, we describe our experience with sacubitril/valsartan, including strategies for the management of adverse events and common patient concerns. In addition, a strategy for the gradual introduction of sacubitril/valsartan using a treatment sequence scheme is proposed.

Epidemiology, management, and outcomes of sustained ventricular arrhythmias after continuous-flow left ventricular assist device implantation.

BACKGROUND: Left ventricular assist devices (LVADs) are pivotal treatment options for patients with end-stage heart failure. Despite robust left ventricular unloading, the right ventricle remains unsupported and susceptible to hemodynamic perturbations from ventricular arrhythmias (VAs). Little is known about the epidemiology, management, resource use, and outcomes of sustained VAs in continuous-flow LVAD patients. METHODS: We reviewed data from all consecutive patients receiving a continuous-flow LVAD at the University of North Carolina from January 2006 to February 2011. Patient demographics, pharmacotherapies, resource use, and outcomes were recorded. Descriptive statistics were generated, and multivariable logistic regression was used to assess the independent association of clinical variables on the development of postimplantation VAs. RESULTS: Of 61 patients, 26 (43%) had sustained VAs after LVAD. Most were male (65%), had history of hypertension (65%), and had nonischemic cardiomyopathy (62%). Patients with VAs after LVAD more often had preimplant VAs (62% vs 14%, P < .01), prior implantable cardioverter-defibrillator (92% vs 71%, P = .04), and history of implantable cardioverter-defibrillator discharge (38% vs 11%, P < .01). Although length of stay was similar, those with postimplant VAs had greater rehospitalization rates, greater antiarrhythmic drug use, and frequently required external defibrillation. Using multivariable logistic regression, only history of prior VA was associated with postimplant arrhythmias (odds ratio 13.7, P < .001). CONCLUSIONS: Ventricular arrhythmias in LVAD patients are common, often refractory to conservative therapy, and associated with frequent rehospitalization. Post-LVAD VAs, however, did not significantly impact survival or transplantation rates. Arrhythmia burden should be considered before LVAD placement, and future study should focus on the impact of VAs on quality of life.

Registration of myocardial PET and SPECT for viability assessment using mutual information.

PURPOSE: The combination of sequentially acquired cardiac PET and SPECT data integrating metabolic and perfusion information allows the assessment of myocardial viability, a relevant clinical parameter for the management of patients who have suffered myocardial infarction and are now candidates for complex and cost intensive therapies such as bypass surgery. However, registration of cardiac functional datasets acquired on different imaging systems is limited by the difficulty to define anatomical landmarks and by the relatively poor inherent spatial resolution. In this article, the authors sought to evaluate whether it is possible to automatically register FDG-PET and sestamibi-SPECT cardiac data. METHODS: Automatic rigid registration was implemented with the ITK framework using Mattes mutual information as the similarity measure and a quaternion to represent the rotational component. The goodness of the alignment was evaluated by computing the mean target registration error (mTRE) at the myocardial wall. The registration parameters were optimized for robustness and speed using the data from 11 cardiac patients undergoing both PET and SPECT examinations (training datasets). The optimized algorithm was applied on the PET and SPECT data from 11 further patients (evaluation datasets). Quantitative (mTRE calculation) and visual (scoring method) comparisons were performed between automatic and manual registrations. Moreover, the automatic registration was also compared to the registration implicitly defined in the standard clinical analysis. RESULTS: The registration parameters were successfully optimized and resulted in a mean mTRE of 1.13 mm and 1.2 s average runtime on standard computer hardware for the training datasets. Automatic registration in the 11 validation datasets resulted in an average mTRE of 2.3 mm, with 7.5 mm mTRE in the worst case and an average runtime of 1.6 s. Automatic registration outperformed manual registrations both for the mTRE and for the visual assessment. Automatic registration also resulted in higher accuracy and better visual assessment as compared to the registration implicitly performed in the standard clinical analysis. CONCLUSIONS: The results demonstrate the possibility to successfully perform mutual information based registration of PET and SPECT cardiac data, allowing an improved workflow for the sequentially acquired cardiac datasets, in general, and specifically for the assessment of myocardial viability.

Osteoporosis screening by community pharmacists: use of National Osteoporosis Foundation resources.

OBJECTIVES: To assess the feasibility of establishing an osteoporosis screening program in rural community pharmacies based on information and resources provided by the National Osteoporosis Foundation (NOF), to survey primary care providers regarding the usefulness of this screening program, and to recommend strategies for pharmacists interested in working with patients at risk for osteoporosis. DESIGN AND PARTICIPANTS: Pharmacists and/or nurses enrolled women 65 years of age and older into the study, measured calcaneal bone density, administered a questionnaire to ascertain subjects' osteoporosis risk factors, and provided NOF literature to subjects. With their agreement, women's bone mass data and risk factor assessments were provided to primary care providers along with NOF's Physician's Guide to Prevention and Treatment of Osteoporosis. These providers were surveyed as to whether they found this information useful. SETTING: Five independent community pharmacies in rural Wisconsin. RESULTS: We enrolled and tested 133 women. Of these, 122 (92%) agreed to have information mailed to their primary health care providers. These 57 providers were surveyed and 24 (42%) responded; of these 24, 20 (83%) found the information they received useful. CONCLUSION: A community pharmacy-based osteoporosis screening program using NOF materials was well accepted by physicians. NOF resources and recommendations can provide a strong foundation for such programs.