Application of PCSK9 Inhibitors in Practice.

PCSK9i (protein convertase subtilisin/kexin type 9 inhibitors) are set to revolutionize the treatment of hypercholesterolemia in the management of atherosclerotic risk, but numerous reports have detailed unprecedented barriers to access for these drugs. To overcome these challenges, our group created a model to facilitate provision of this new therapy for patients who qualify according to Food and Drug Administration criteria. This report details the real-world follow-up experience of PCSK9i use in a large patient cohort structured to ensure rigor in data collection, analysis, and interpretation. The 271 patients approved and actively followed in our PCSK9i clinic between July 2015 and August 2018 represent a 97% approval rate from insurance, with 28% of prescriptions requiring at least one appeal. Over 50% of patients were statin intolerant. On average, there was a median lapse of 15 days between initial visit and insurance approval. PCSK9i therapy was affordable for most patients, with an average monthly out-of-pocket expense of $58.05 (median $0). Only 2.3% of patients were unable to initiate or continue therapy because of cost. Reductions from baseline in LDL (low-density lipoprotein) cholesterol and Lp(a) (lipoprotein [a])were comparable to published reports with median reductions of 60% and 23% at 1 year, respectively. PCSK9i therapy was well-tolerated overall, though 9% of patients reported adverse events, and 5% of patients discontinued due mostly to musculoskeletal and flu-like symptoms. Our practice model demonstrates that PCSK9i therapy can be accessed easily and affordably for the majority of eligible patients, resulting in dramatic improvement in lipid profile results. Moreover, our registry data suggest that results from the prospective clinical trials of PCSK9i on LDL and Lp(a) reduction and on tolerability are applicable to a real-world cohort.

Cardiac Rehabilitation for Adults With Congenital Heart Disease: Physical and Psychosocial Considerations.

Owing to significant medical advances, it is now estimated that more than 90% of persons born with congenital heart disease (CHD) will reach adulthood. Medically appropriate physical activity represents an opportunity to improve physical functioning as well as quality of life and psychosocial outcomes. By reviewing published CHD research and clinical recommendations, herein we first summarize how adults with CHD are known to be less physically active and have reduced exercise capacity compared with healthy peers. Cardiopulmonary exercise testing is important for routine clinical management and before the onset of an exercise program. Physiological anomalies are common in adults with CHD, although very few necessitate activity restrictions, and positive results from exercise training have been demonstrated. In recent decades, the focus has thus shifted from restriction of exercise to promotion of exercise. Adults with CHD also face unique psychosocial challenges associated with living with a chronic cardiac condition, many of which may influence exercise behaviours. However, much less is known about participation of adults with CHD in cardiac rehabilitation (CR) programs, which differ from exercise training in their comprehensive, interdisciplinary approach to management of chronic disease and that might be uniquely poised to meet the physical and psychosocial needs of adults with CHD. Initial CR outcomes have been positive and with no reported adverse events. This review summarizes the unique physical and psychosocial considerations that may guide the provision of CR to adults with CHD.