Study Finds Adopting ACA Medicaid Expansion Increased Heart Transplant Listings in African-Americans The implementation of the Affordable Care Act (ACA) Medicaid Expansion was associated with increased heart transplant listings in African-Americans, according to a study published Jan. 18 in JACC: Heart Failure. Using the Scientific Registry of Transplant Recipients, Khadijah Breathett, MD, et al., analyzed 5,651 patients from early adopter, states that implemented the expansion by Jan. 2014, and 4,769 patients from non-adopter states from 2012 to 2015. Piecewise linear models, stratified by race and ethnicity, were fit to monthly census-adjusted rates of heart transplant listings before and after Jan. 2014. The authors observed a 30 percent increase in the rate of heart transplant listings for African-Americans immediately following ACA Medicaid Expansion in early adopter states. In contrast, the rate of heart transplant listings for African-Americans in non-adopter states remained constant. The authors also found that Hispanics experienced an opposite trend, with the rates showing no significant change in early adopter states but an increase in non-adopter states. There were no significant changes in listing rates among Caucasians in either early adopter or non-adopter states. According to the authors, the findings suggest that improved access to insurance may be a partial solution to reducing racial and ethnic disparities in organ allocation in the U.S. “Because the number of donor hearts is limited, it is critical that different racial and ethnic groups have equitable access to this scarce resource,” said Breathett. “In some states, patients with basic health care coverage like Medicaid may not be given equitable candidacy as patients with Medicare and private insurance since Medicaid programs will not universally cover costs of transplantation. It is paramount to avoid increasing racial/ethnic disparities as the selection process is calibrated particularly among politically divided Organ Procurement Organizations.” In an accompanying editorial, Marvin A. Konstam, MD, FACC, suggests that this progress towards eliminating disparity in heart transplant allocation should not be abandoned. He explains that, “If we achieve consensus around our core goals, then there is no escaping a role of government in subsidizing health care for our least fortunate citizens, but beyond this fact, there are other legitimate choices to make: the relative roles of the private vs. public sectors; service-based vs. value- and population-based payment models; and payer focused vs. provider- and patient-focused decision making and risk bearing.” Konstam concludes with this sentiment, “Let us hope that as this next round of the debate unfolds, it focuses less on the name of the act and more on serving the health care needs of our entire population.” Alcohol Abuse May Increase Risk of Heart Disease Alcohol abuse may increase the risk of atrial fibrillation, myocardial infarction (MI) and congestive heart failure as much as other well-established risk factors such as high blood pressure, diabetes, smoking and obesity, according to a study published Jan. 2 in the Journal of the American College of Cardiology. Gregory M. Marcus, MD, FACC, and colleagues analyzed data from a database of all California residents ages 21 and older who received ambulatory surgery, emergency or inpatient medical care in California between 2005 and 2009. Approximately 268,000 patients had been diagnosed with alcohol abuse. The researchers found that after taking into account other risk factors, alcohol abuse was associated with a two-fold increased risk of atrial fibrillation, a 1. 4-fold increased risk of MI and a 2. 3-fold increased risk of congestive heart failure. These increased risks were similar in magnitude to other well-recognized modifiable risk factors such as diabetes, high blood pressure and obesity. According to the researchers, ending alcohol abuse would result in over 73,000 fewer atrial fibrillation cases, 34,000 fewer Mis, and 91,000 fewer patients with congestive heart failure in the U.S. “We found that even if you have no underlying risk factors, abuse of alcohol still increases the risk of these heart conditions,” Marcus said. “We were somewhat surprised to find those diagnosed with some form of alcohol abuse were at significantly higher risk of a heart attack. We hope this data will temper the enthusiasm for drinking in excess and will avoid any justification for excessive drinking because people think it will be good for their heart. These data pretty clearly prove the opposite.” In a related editorial, Michael H. Criqui, MD, MPH, and Isac C. Thomas, MD, state “alcohol is a potentially addictive and dangerous drug, both for the cardiovascular system and multiple other organ systems. The recent infatuation with the potential benefits of lightto- moderate drinking for cardiovascular disease protection appears to be based on observational and subtly confounded data, rather than on randomized controlled trial evidence, and perhaps on more than a little wishful thinking.” Enteric-Coating Affects Aspirin Responsiveness in Diabetes Patients A high proportion of patients treated with enteric-coated aspirin failed to achieve complete inhibition of serum thromboxane B2 (TXB2) generation due to incomplete absorption, according to a study published Jan. 5 in the Journal of the American College of Cardiology. Deepak L. Bhatt, MD, MPH, FACC, and colleagues measured the rate and extent of serum thromboxane generation and aspirin pharmacokinetics in 40 patients with diabetes. Patients were exposed to three 325 mg aspirin formulations: plain aspirin, PL2200 (a modified-release lipid-based aspirin), and a delayed-release enteric-coated aspirin. Onset of antiplatelet activity was determined by the rate and extent of inhibition of TXB2 generation. The rate of aspirin nonresponsiveness was 15.8 percent, 8.1 percent and 52.8 percent for plain aspirin, PL2200 and enteric-coated aspirin, respectively. Additionally, 56 percent of patients treated with enteric-coated aspirin had serum TXB2 levels >3.1 ng/ml, versus 18 percent and 11 percent of patients after administration of plain aspirin and PL2200. Compared with findings for plain aspirin and PL2200, this high rate of nonresponsiveness with enteric-coated aspirin was associated with lower exposure to acetylsalicylic acid and 66 percent and 72 percent lower maximal decrease of TXB2, with marked interindividual variability. “These results confirm that if a rapid aspirin effect is necessary, as in acute myocardial infarction, an immediate-release formulation (i. e., plain aspirin) is the therapy of choice,” the authors write. “For chronic dosing as well, there does not seem to be any benefit with enteric-coated aspirin.” The authors add that moving forward, additional studies are needed to assess the clinical relevance of this pharmacokinetic and pharmacodynamic trial. Review Shows Medication Nonadherence Presents a Variety of Challenges Increasing medication adherence in cardiovascular disease patients requires a multidimensional approach, according to a state-of-the-art review published Jan. 23 in the Journal of the American College of Cardiology. The review, led by Keith C. Ferdinand, MD, FACC, et al., summarized key material from a symposium on medication adherence convened by the U.S. Food and Drug Administration (FDA) as part of the Million Hearts Campaign, and determined five key factors that affect medication adherence: socioeconomic, health care system-related, medical-conditionrelated, therapy-related and patientrelated factors. Socioeconomic, health care-systems related and therapyrelated factors appeared to have the most influence on overall adherence rates. Socioeconomic factors include unstable living conditions (including homelessness), lack of health insurance, lack of family or social support network, medication cost and limited English proficiency. Levels of education and literacy were also noted as important factors. Health care systems-related factors include lack of positive reinforcement from provider, poor access/missed appointments, patient information materials written at too high a literacy level, high drug costs/copayments and lack of continuity of care. Teambased care can be effective in increasing adherence and improving health outcomes. Complex regimens, side effects, long regimens and prescription refill patterns across different time points were named as some of the therapy-related factors in nonadherence. “These findings suggest a need for common-sense approaches to simplifying regimens and clear logistics as critical factors in better adherence,” stated the authors. The FDA is partnering on efforts to increase medication adherence, and will continue to pursue improving access to generic medications, expanding post-market safety monitoring, exploring effective strategies to improve health literacy, requiring medication guides to be issued to consumers with certain prescribed medications, developing a framework to release up-to-date prescription drug product information to consumers, and more. Experimental Drug May Repair Failing Hearts Cimaglermin, a new experimental drug, may help restore cardiac function after heart failure, according to a first-in- man study published Dec. 26 in JACC: Basic to Translational Science. Daniel J. Lenihan, MD, FACC, and colleagues examined the safety and efficacy of a single infusion of cimaglermin, which acts as a growth factor for the heart, helping the structural, metabolic and contractile elements of the heart to repair itself following injury. The study included 40 heart failure patients taking optimal medical therapy for at least three months prior to the trial. Compared with placebo, a high dose of cimaglermin resulted in a sustained increase in left ventricular ejection fraction through 90 days, with the maximum increase reached at day 28. The most common side effects were headache and nausea, which were temporarily associated with exposure to the drug. One patient receiving the highest planned dose of cimaglermin experienced an adverse reaction that met the stopping criteria of Food and Drug Administration guidance for drug-induced liver injury. “Although the results of the study must be regarded as provisional because of the small numbers of patients, the results of this study are nonetheless very exciting,” said Douglas L. Mann, MD, FACC, editor-in-chief of JACC: Basic to Translational Science. “Instead of blocking the fundamental mechanisms that lead to cardiac injury, the early results with cimaglermin suggest that it may also be possible to administer therapeutics that allow the failing heart to repair itself using its own repair mechanisms. If the results of this study can be replicated and translated into improvements in clinical outcomes in larger numbers of patients in phase II and III clinical trials, it will represent a paradigm shift in the way in which clinicians treat patients with heart failure.” Are Very Low LDL Cholesterol Levels From Alirocumab Safe For Patients? Heart disease patients taking the PCSK9 inhibitor alirocumab to achieve very low levels of cholesterol may not experience an increase in adverse events, including memory impairment or nervous system disorders, but may have an increased risk of cataracts, according to a study published Jan. 30 in the Journal of the American College of Cardiology. Jennifer G. Robinson, MD, MPH, and colleagues pooled data from 14 randomized, controlled studies that included 5,234 patients treated with alirocumab for up to two years. They looked for the occurrence of adverse events in patients who achieved two or more consecutive LDL cholesterol values of less than 25 mg/dl or less than 15 mg/dl. The overall incidence of adverse events was similar in patients taking alirocumab versus those taking a placebo, including musculoskeletal events, neurologic conditions, neurocognitive events (including memory), renal events or liver events. There was not an increased incidence of diabetes, despite prior studies showing an excess of diabetes in patients with LDL levels lower than 30 mg/dl on statin therapy. There was an increased incidence of cataracts in patients with LDL less than 25 mg/dl versus greater than 25 mg/dl. The authors note this could be a chance finding, or it could be because reducing cholesterol accelerates underlying aging-related changes, contributing to cataracts. “The safety of these new drugs is critical to patients who have no other means by which to control their life-threatening high cholesterol,” said Robinson. “The longterm effects of very low levels of LDL cholesterol are under evaluation in ongoing large clinical trials.” In a related editorial, Brendan M. Everett, MD, FACC, adds that “the data presented here, although reassuring, represent only the beginning of our understanding of the safety of this novel class of medications. The ongoing cardiovascular endpoint trials of alirocumab should provide not only a sense of the true cardiovascular benefit of these drugs but also a more accurate and nuanced understanding of their risks.” “Two very large PCSK9 endpoint trials will be presented at ACC.17 in March,” said Kim A. Eagle, MD, MACC, editor-in-chief of ACC.org.
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