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CLINICAL NEWS American College of Cardiology Extended Learning 12-month follow-up. A recovery index (for patients with more than 1-year follow-up) was created to evaluate CCSAC over time. Almost all patients presented progressive improvement in CCSAC beginning at 3 months post-procedure (p = 0.002), which was sustained at 12-month follow-up (p = 0.002), as well as objective myocardium ischemic area reduction at 6 months (decrease of 15%; p < 0.024) and 12 months (decrease of 100%; p < 0.004). QOL per SF-36 questionnaire improved significantly in almost all domains. Cost-effectiveness analysis showed decreases in angina-related direct costs. Refractory angina patients presented a sustained long-term improvement in CCSAC and myocardium ischemic areas after the procedure. Thus, the authors concluded: “Promonocytes may play a key role in myocardial neoangiogenesis. ReACT dramatically decreased direct costs.” TISSUE ENGINEERING One of the limitations of current approaches to stem cell therapy is the short retention time (days to maybe a few weeks). It is only during this time that cells remain in the target tissue after transplantation. A great deal of progress has been made in the field of tissue engineering to design new methods to increase cell retention. These include what Dr. Miller calls “remarkable work” on the development of scaffolds using both natural and synthetic materials, including extracellular matrix to hold To listen to the interview with Leslie either stem cells or genes for W. Miller, MD, visit slow and programmed release. the CSWN YouTube In addition, scaffolds are being channel or scan the QR. Interview developed with cells implanted conducted by Peter for delivery to the target tissue. A. McCullough, MD. One of the most exciting approaches to tissue engineering is the concept of organogenesis or creation of whole organs that might potentially be used for elective, off-theshelf transplantation. Research in this area has demonstrated both the complexity of individual tissues and cells within each organ, the challenging requirements of creating equipment to sustain and test these constructs, as well as which cell to use given the astounding plasticity of transplanted cells. According to Dr. Miller and colleagues, in the introduction to their new book, “We believe we are on the threshold of a new era of regenerative medicine taking advantage of the lessons learned in the past decade and the strategies moving into clinical trials.” ■ REFERENCES: 1. Perin EC, Miller LW, Taylor D, Willerson JT. Stem Cell and Gene Therapy for Cardiovascular Disease. 1st edition. Waltham, MA: Academic Press, 2015. ISBN: 9780128018880. 2. Perin EC, Borow KM, Silva GV, et al. Circ Res. 2015;117:576-84. 3. Hossne NA, Cruz E, Buffolo E, et al. Cell Transplant. 2015;24:955-70. 20 CardioSource WorldNews Lipid Therapy 2016: The ‘Doughnut’ Hole and PCSK9 Sticker Shock W e have recent cholesterol guidelines,1 multiple studies confirming that the guidelines got it right (putting to rest much of the original criticism), and new agents recently approved that can dramatically lower LDL-C levels in patients, including those already on statin therapy. Thus, nothing left to discuss here, right? Well, not so fast: there are still a few issues. THE DOUGHNUT HOLE C. Noel Bairey Merz, MD, director of the Barbra Streisand Women’s Heart Center and director of the Preventive Cardiac Center at Cedars-Sinai Heart Institute, Los Angeles, CA, recently addressed the doughnut hole in the guidelines. As a member of the expert panel, she said they were charged by the National Heart, Lung, and Blood Institute to develop new cholesterol guidelines an d told to evaluate only higher-quality randomized controlled trial (RCT) data. No need to reiterate the value of RCT data here, but that leaves a narrow field of data that misses huge swaths of the population. Let’s face it, there is limited generalizability of the available data for the unstudied, including those younger than age 40 or older than age 75. For example, in these two broad age groups, there is wholly underpowered subgroup data in women and non-whites, limiting guidelines for these dominant groups. (Women comprise a total of 52% of the population, while non-white individuals are projected to make up more than half of the population by 2020.) Sure, there have been subgroup analyses, but Dr. Bairey Merz is pointing to the challenge of making clinical decisions based on limited data from studies of inadequate sample size, low event rates, and limited trial durations, thus limiting precision, accuracy, and relevance of trial subgroup analyses. Consensus is that subgroups should be treated according to trial evidence of risk and benefit until proven otherwise. Having acknowledged that, Dr. Bairey Merz asked: Can the guidelines be based only on clinical trials? • How confident are we that statins do not save lives in subgroups (age, sex, ethnicity)? • What do we value? For example, is reduction in revascularization and angina hospitalization— which both impact morbidity and cost—provide justification for the use of statins for primary prevention? January 2016