EMERGING TRENDS IN CARDIOVASCULAR MEDICINE It’s the age-old question as we return to work after the end of year break: what lies ahead in the coming year? Leading cardiovascular professionals anticipate a year with a potential revolution in the prevention arena, spurred by advances in lipid management, and anticipate the evolution of drugs and technologies as they move more fully into clinical practice and are monitored and refined. “This is the most exciting time in cardiovascular medicine, with an exponential explosion in science and data, along with the beginning of the evolution of population-based medicine to personalized medicine,” says ACC President Richard A. Chazal, MD, FACC. This is also the most challenging time, he says, as cardiovascular professionals work to integrate the deluge of science into their practice, while taking the next steps in the journey to ensure the quality of care for their patients through the move to value-based care, amidst a time of potential uncertainty with a new government administration. The specter of repeal or revision of the Affordable Care Act and other policy changes is palpable. Health care reform is an economic need, acknowledges Chazal, yet there is an “ethical and moral need to serve patients,” and the College is committed to continue to advocate for patients and to work with any administration. The biggest question in health care in 2017 is what will be the impact of these changes on the delivery of health care, says Spencer B. King III, MD, MACC, editor-in-chief of JACC: Cardiovascular Interventions. “A major concern is whether the advances in cardiovascular medicine will be available to everyone,” he adds. The bipartisan creation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) leads many to believe it will continue. While there may be some tweaks to its implementation, the ACC membership should continue to prepare, says Chazal. Additionally, the federal mandate requiring Appropriate Use Criteria at the point of care for advanced cardiovascular imaging will be implemented by all hospitals in 2017 and affect all of cardiology. New reimbursement rates for cardiac rehabilitation are also ahead. PREVENTION AND HEALTH PROMOTION Perhaps one of the most anticipated studies of the decade is FOURIER, the first of the cardiovascular outcomes studies of PCSK9 inhibition, says ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC, with many expecting the results in the first half of the year. If PCSK9 inhibition with evolocumab is safe and effective in reducing cardiovascular events in FOURIER, the results will have “a substantial impact on how we address residual risk in patients,” says Nathan Wong, PhD, FACC. Some believe the results from FOURIER could revolutionize the treatment of coronary artery disease (CAD) and the primary and secondary prevention of atherosclerotic cardiovascular disease. Among the implications of positive PCSK9 outcomes studies, along with their cost, is whether they will lead to population screening, perhaps through biomarkers or noninvasive assessment of coronary calcium, to identify preclinical disease for earlier intervention, and the need to better define true statin intolerance. Further stoking the hope for a win with PCSK9 inhibition is the finding of atheroma regression and continued benefit with LDL-C reduction to 20 mg/dl in the GLAGOV trial with evolocumab added to statin therapy, as reported by Steven Nissen, MD, MACC. And another approach to PCSK9 inhibition, RNA interference of its synthesis, produced substantial reductions in LDL-C in the phase 2 ORION study. “This is the closest thing to a vaccination yet,” says Wong, with a subcutaneous injection that is given a couple of times a year. “The LDL hypothesis is alive and well,” says ACC.17 Chair Jeffrey T. Kuvin, MD, FACC, who adds that the benefit of LDL reduction has been extended to intermediate-risk patients without known CAD by the results of the HOPE-3 trial. Presented at ACC.16, the study showed in an ethnically diverse population that rosuvastatin reduced cardiovascular death, myocardial infarction, or stroke. The Million Hearts Initiative will be kicked up another notch starting in 2017 with the Cardiovascular Risk Reduction Model, a randomized test of a value-based payment system for managing a population of high-risk patients in a provider’s patient panel using evidence-based medicine to reduce the 10-year predicted risk for atherosclerotic cardiovascular disease. “This a welcomed effort to better support prevention activities, by targeting multiple cardiovascular risk reduction strategies longitudinally in patients with high atherosclerotic cardiovascular disease risk,” says Salim Virani, MD, FACC. A new risk assessment tool to support this initiative was recently launched by the ACC and the American Heart Association. “Health promotion is an important trend that is taking root and growing,” says JACC Editor-in-Chief Valentin Fuster, MD, PhD, MACC. A conceptual change that focuses on understanding health from a variety of levels, it is a main priority for funding by the National Heart, Lung, and Blood Institute over the next decade. Fuster and his colleagues are using imaging to identify possible mechanisms that contribute to degenerative brain disease and the acceleration of Alzheimer’s disease and relate the risk factors that affect the large arteries with the tiny vessels in the brain. Another evolving area is improving medication adherence for secondary prevention after a myocardial infarction or stroke with a polypill containing aspirin, an ACE inhibitor and a statin. The polypill has been approved in 27 countries, and U.S. Food and Drug Administration (FDA) approval may come within the next two years. “We must work with people at younger ages and work at the family and community level,” says Fuster, to change health behaviors to prevent cardiovascular disease. The successful Sesame Street initiative of educating children age 3-5 years worldwide is expanding to families, with one project working with 600 families in Harlem in New York City. Another project is looking at whether early detection of developing disease, using 3-D ultrasound, will lead to changes in health behaviors in younger people (age 25-55 years) who are seemingly healthy. Digital health and mobile technology solutions will evolve during 2017 to manage health and disease. Eagle predicts an increasing investment in the development of these mobile interfaces, and hopes they will encourage more accountability by patients for their daily health habits. Already they are being used to transmit heart rhythms in patients experiencing palpitations. Virani adds there is a lot of promise these solutions can be used to improve risk factor management, and comparative effectiveness studies will begin to identify “the real winners.” Virani also sees mobile technology as a valuable tool to improve interaction with patients worldwide, noting that a great majority of the global population has access to a cell phone, including low- and middle-income countries. This also provides an innovative platform for pragmatic, epidemiologic studies, by collecting data via cell phones from large numbers of patients, for example to better understand cardiovascular risk factors. Digital health solutions will be used to better manage the deluge of data, and platforms will be developed to integrate the data into knowledge that can be employed by health care providers. In the move to value-based care, the health care team will be supported at the point of care by solutions sets created by the College, such as the Valvular Heart Disease Initiative. “These tools are the intersection of guidelines, clinical data, and consensus clinical pathways,” says Richard J. Kovacs, MD, FACC, chair of ACC’s Science and Quality Committee, and will be a more common theme in 2017. Further advances in using big data, including leveraging NCDR registries, will also guide the journey to value in clinical practice. TRENDS IN MANAGING DISEASE Cardio-oncology and cardio-diabetology are emerging disciplines. Many large centers now are developing teams of cardiovascular professionals and oncologists for managing patients who survive their cancer but suffer treatmentrelated effects on the heart, now a large area of research. Managing diabetes may become more of a focus for cardiovascular professionals, with two-thirds of their patients having diabetes or pre-diabetes, and two classes of glucose-lowering drugs were shown to have cardiovascular benefit in recent clinical trials, says Wong. For coronary interventions, the recent publications of the EXCEL and NOBLE trial will likely increase the use of stenting for left main coronary disease. Another key question is where the bioabsorbable stents and scaffolds fit in practice, because the news from recent trials, including ABSORB II and III, “is not as encouraging as expected,” says King. It is likely that continued advances to the technology will be needed before there is broad use. Fractional flow reserve by computed tomographic (CT) angiography for guiding reperfusion will move forward, says Jagat Narula, DM, MD, PhD, MACC. CT angiographic characterization of the lesions would add a new dimension to the anatomic and physiologic relevance of coronary stenosis and should offer superior prognostic determination. CT angiography has started to gain ground as the most important go-to technique at least in people without known CAD. A challenge in the field of imaging is determining its appropriate use. Even though imaging is not adequately employed yet, its escalating cost is not sustainable, says Narula. Refining whether the imaging discipline evolves as a multimodality service or with multimodality imagers or whether there will be niche areas for imaging modalities is another challenge ahead, he adds. In structural heart disease, transcatheter aortic valve replacement (TAVR) and the MitraClip and Watchman devices are “moving into the standard repertoire and we will be learning how to integrate them into more routine care,” says Kovacs. Their real-world performance will be monitored for safety and efficacy. Some exploration of TAVR in lower-risk patients is anticipated, but the durability of the valve in these patients remains a concern that will not be addressed for about another five years when there is more follow-up data, Eagle says. The next potential frontier being explored is non-operative mitral valve replacement and whether it works well enough to find a sizable role. The performance of the Watchman device for left atrial appendage closure, approved for selected patients with contraindications to anticoagulation, will be watched closely. An alternative is thorascopic surgical isolation of the left atrial appendage for patients with anatomic considerations that exclude the use of a Watchman, and this will be refined in the year ahead. The treatment of thrombotic disorders with non-warfarin, direct-acting oral anticoagulants (DOACs) continues to evolve. Although approved for nonvalvular atrial fibrillation, Eagle thinks their use will expand. One area may be coronary stenting now that the PIONEER-AF PCI study showed that the DOAC rivaroxaban is safer than warfarin when combined with an antiplatelet. The availability of reversal agents is expected to expand the use of the DOACs, although they are reserved for life-threatening bleeds. A reversal agent for dabigatran, called idarucizumab, has been approved, and the approval of andexanet alfa for Factor Xa DOACs may come in 2017. Under development is a third reversal agent that is universal and would be the “magic bullet” to reverse any antithrombotic, says Geoffrey Barnes, MD, Msc, FACC. In phase 2 studies now, ciraparantag (PER977) is about two years out. Leadless pacemakers and defibrillators, eliminating the issue of blood-borne infections within the device, and the use of smaller technology that can be injected with a needle for monitoring arrhythmias are rapidly moving areas. New technical approaches to ventricular tachycardia are being explored. In heart failure, the underutilization of sacubitril/valsartan and ivabradine, two new drugs that reduce mortality and/or hospitalization, will be a focus. “Remote monitoring of data is the future, but is a challenge now because of the infrastructure and data management it requires” says Christopher M. O’Connor, MD, FACC, editor-in-chief of JACC: Heart Failure. Efforts to improve transition of care and develop risk prediction models using electronic health records are evolving. Individualized treatment approaches using biologic markers, DNA, and pharmacogenomics variance to determine resistance or sensitivity to a drug are being explored. Smaller mechanical support devices and smaller, safer implantable pumps with fewer complications, along with wearables, are being developed. The GUIDE-IT trial results are expected early in 2017 and will improve insights on using evidence-based medicine and the serial measurement of NT-proBNP to guide medication titration. The RELAX-AHF-2 trial with serelaxin when reported midyear may lead to the first drug to improve outcomes in acute heart failure. Looking farther down the road at what will impact cardiovascular medicine, there is active work in genetics and tissue regeneration. Just read through any issue of JACC or JACC: Basic to Translational Science to see the growing contributions. Myocardial disease and cardiomyopathy are a focus of genetics research, and work with induced multipurpose cells for tissue regeneration is leading to a better understanding of the mechanisms of diseases, including genetic and inherited disease, Fuster says. Novel research with gene editing holds great promise in neuromuscular diseases such as Duchenne and Becker muscular dystrophy, which also affects cardiac muscle, and is an emerging trend, says Douglas L. Mann, MD, FACC, editorin- chief of JACC: Basic to Translational Science. A recent FDA approved exon-skipping drug for Duchenne’s highlights the progress for these diseases, and the promise of genetic editing for cardiovascular medicine. Kim A. Eagle, MD, MACC, editor-in-chief of ACC.org, and Deepak L. Bhatt, MD, MPH, FACC, senior associate editor of ACC.org, share their picks for the top 10 cardiovascular trials of 2016. Do you agree? Share your top 2016 trials on Twitter with @ACCinTouch using #CVTop10. 2016’s Top 10 Trials 1 . EMPA-REG OUTCOME The EMPA-REG OUTCOME trial showed that empagliflozin is superior to placebo in improving glycemic control and reducing cardiovascular events including mortality in patients with type 2 diabetes and established cardiovascular disease. 2 . EUCLID The EUCLID trial failed to show that ticagrelor was superior to clopidogrel among patients with peripheral arterial disease. 3 . EXCEL The EXCEL trial showed that PCI with secondgeneration DES (Xience) is noninferior to CABG for clinical outcomes at three years following revascularization of unprotected left main lesions. 4 . HOPE-3 The HOPE-3 trial showed that fixed-dose treatment with low-dose statin therapy, but not blood pressure agents, is superior to placebo in reducing long-term cardiovascular events in an intermediate-risk population; the combination group had benefits similar with the statin arm. 5 . LEADER The LEADER trial showed that liraglutide, a glucagon-like peptide-1 (GLP-1) agonist, was superior to placebo in improving glycemic control and reducing cardiovascular events in high-risk patients with type 2 diabetes. 6 . MOMENTUM 3 The MOMENTUM 3 trial showed that a centrifugal-flow left ventricular assist device was superior at preventing pump thrombosis. 7 . NOBLE The NOBLE trial showed that PCI with biodegradable polymer DES (biolimus) is inferior to CABG for clinical outcomes at five years following revascularization of unprotected left main lesions. 8 . PIONEER AF-PCI The PIONEER AF-PCI trial showed that a rivaroxabanbased strategy was associated with less bleeding compared with a warfarin-based strategy after PCI. 9 . PRECISION The PRECISION trial showed similar cardiovascular safety of celecoxib compared with ibuprofen or naproxen. 10 . STAMPEDE The STAMPEDE trial showed that intensive medical therapy plus bariatric surgery is superior to intensive medical therapy alone in achieving adequate glycemic control of type 2 diabetes in obese or overweight patients; results were sustained up to five years of follow-up. The First 100 Days: New Year Brings New President and New Congress Once President-Elect Donald J. Trump takes office on Jan. 20 and Republicans have unified control of the U.S. House and Senate, their 100-day agenda aims to take full advantage of post-election momentum. Top priorities include repealing and replacing the Affordable Care Act (ACA), Cabinet confirmations, raising the debt limit, and passing a spending package. As the new Administration and 115th Congress address health care issues in the coming months, the ACC will work to ensure relationships with federal agencies remain strong and collaborative, health care reform continues to preserve and expand coverage, and medical research is robustly funded. Confirmations The Senate has begun confirming the top 100 leadership positions, including Cabinet secretaries and core teams. Trump has officially announced Rep. Tom Price, MD, as his pick to lead the Department of Health and Human Services (HHS). Price has served in Congress for six terms. A past recipient of the ACC President’s Award for Distinguished Public Service, he currently chairs the House Budget Committee and also sits on the Committee on Ways and Means. Price was a leading figure in the fight to repeal the Sustainable Growth Rate, and has played a key role in efforts to improve electronic health record usability; he has lately been extremely involved in the push to streamline and simplify Meaningful Use reporting requirements. Price has vigorously opposed the Affordable Care Act (ACA); introducing legislation to repeal and replace it in 2015. He has also been a frequent critic of the Center for Medicare and Medicaid Innovation. Should he be confirmed, Price and his policy priorities will be central to the future of these programs. Trump has also selected Seema Verma, MPH, to be the Centers for Medicare and Medicaid Services (CMS) Administrator. Verma has been involved in health care policy for more than 20 years, focusing largely on state-based initiatives, and she has extensive connections to Vice President-Elect Mike Pence. She is the president, CEO and founder of SVC, Inc., a health policy consulting company. Much of her recent work has focused on health care in the state of Indiana. In 2007, Verma helped create and implement Indiana’s Medicaid, Healthy Indiana Plan. She also served as Indiana’s lead on ACA implementation. Barring any unforeseen breaking in Republican ranks, these and other Cabinet nominations will likely be confirmed given Republicans only need a simple majority of 51 votes. Democrats could delay the more controversial confirmations by extending debates. Senate committees with jurisdiction over Cabinet departments will hold hearings on the most important picks before Trump is sworn in as president. After Jan. 20, committees can vote to place nominees before the full Senate. Even as political appointees and some career staff may change, ACC’s ongoing engagement with federal agencies such as CMS, the U.S. Food and Drug Administration, National Institutes of Health, and others in 2017 will be similar to that occurring in 2016. ACA and Budget Reconciliation ACC’s leadership, guided by the Health Affairs Committee, is carefully considering how the College can best engage in this process on behalf of patients and the clinicians who care for them. Both Trump and congressional Republican leaders are expected to move quickly to begin the process of making significant changes to the health insurance reforms and other policies implemented under the ACA. Republicans have said they plan to launch a repeal effort during the first 100 days that would run the budget reconciliation process, allowing for expedited consideration of certain tax, spending and debt limit legislation. Budget reconciliation bills can be passed with a simple majority of 51 votes in the Senate and cannot be filibustered. Eligible ACA changes under budget reconciliation include: repealing individual and employer mandate penalties, rolling back Medicaid expansion, repealing ACA taxes, eliminating cost-sharing subsidies, and limiting medical liability. Republicans’ ACA replacement proposals have outlined measures to give more flexibility to states and small businesses, while encouraging people to maintain unbroken coverage and avoid higher premiums. The replacement timeframe is still being debated, but some Senators have estimated that it could take effect in two to three years. The exact manner and outcome of the ACA repeal effort remains uncertain, but it will be a highly contentious process that will absorb much congressional bandwidth early in the year. Debt Ceiling The current debt limit deal expires on March 16, the first time Congress will have to raise the $20 trillion debt ceiling since 2015 when former House Speaker John Boehner brokered an agreement that suspended the limit for more than a year. When the suspension lifts, the cap will need to be raised or suspended again to avoid default. If the debt ceiling is not extended before March 15, the Treasury Department will use “extraordinary measures” to allow extra time before the ceiling is reached. Lawmakers will have until mid-summer before further action is needed. Spending Package Congress must pass another spending bill by April 28 after passing the continuing resolution Dec. 9 to extend funding for federal government operations at Fiscal Year 2016 levels. The current continuing resolution imposes 0. 19 percent acrossthe- board funding reduction and provides funding for the first full year of the 21st Century Cures Act (see sidebar). Senior appropriators speculate whether the political will exists to pass an omnibus – a bill that packages the smaller appropriations bills into a larger single bill – that will realign funding for Fiscal Year 2017 because Republicans are eager to move as many conservative policy measures as possible within the first 100 days. “At the end of the day, the ACC has a long-standing history of working across political parties to advance the College’s mission of transforming cardiovascular care and improving heart health,” said Richard A. Chazal, MD, FACC, president of the ACC, and Thad Waites, MD, FACC, chair of the ACC Health Affairs Committee, in a recent email to members. “We look forward to working with the new presidential administration and Congress in the New Year around policies that protect patient access to quality, cost-effective care and ensure continued funding for things like cardiovascular research and graduate medical education.” Stay tuned to ACC.org/Advocacy and the ACC Advocate newsletter for updates. 21st Century Cures Act Signed Into Law In December, President Barack Obama signed into law the 21st Century Cures Act, bipartisan, bicameral legislation related to medical innovation. Prior to the president’s signature, the bill passed overwhelmingly in the House (392-26) and the Senate (95-4). For nearly all of the 114th Congress, the College was closely engaged with committees in both the House and Senate working to create a package of medical innovation bills, and the 21st Century Cures Act includes a number of ACC’s advocacy priorities. The following provisions are of special interest to the profession of cardiology: • Provides $4.8 billion (subject to appropriations) over 10 years in funding to the National Institutes of Health for the Precision Medicine Initiative, the Brain Research Through Advancing Innovative Neurotechnologies Initiative, cancer research and regenerative medicine using adult stem cells. • Provides $500 million over 10 years to the U. S. Food and Drug Administration (FDA) to move drugs and medical devices to patients more quickly, while maintaining the same standard for safety and effectiveness. • Facilitates faster marketing of drugs and medical devices at lower cost by making needed reforms to the FDA. For more on these and other provisions included in the law, visit ACC.org/Advocacy.
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