December 24, 2013 — Clinical trials for a promising new class of cholesterol-lowering medications, a long-awaited repair of the Medicare formula for paying physicians, the Affordable Care Act, new technology and the implementation of new prevention guidelines are among the top developments in cardiology anticipated for 2014.
Leaders from the American College of Cardiology (ACC) identified the following issues to watch for in the new year:
Affordable Care Act’s Individual Mandate for Health Insurance Coverage
The new health plan takes effect Jan. 1. The medical community, including cardiology, will be watching and working to adjust as payment models change and more patients have access to medical care. Some heart disease patients may see a cardiologist for the first time as they get access to care through plans established because of the Affordable Care Act.
Sustainable Growth Rate Permanent Fix
Congress seems closer than ever to passing a fix to the flawed formula for calculating physician pay under Medicare enacted almost two decades ago. The Senate Finance and House Ways and Means committees passed a permanent sustainable growth rate (SGR) fix Dec. 12, but the House and Senate only passed a three-month patch to avoid a 20 percent Medicare payment cut on Jan. 1. The full Congress is expected to vote on and pass legislation to permanently repeal the SGR in 2014, before that patch expires. A permanent repeal would be good news for Medicare patients, as many physicians would be unable to continue to see Medicare patients if payments for physicians were cut so dramatically. It would also stop the almost annual exercise of Congress approving a last-minute patch.
Development of PCSK9 Inhibitors
Multiple trials are in progress for this anticipated new class of drugs that dramatically decrease LDL cholesterol, known as “bad” cholesterol. PSCK9 inhibitors mimic a gene found in people with naturally low LDL. The drug interferes with the destruction of the LDL receptor. The new class could have a big impact on the treatment of patients not able to tolerate statin medications or those with very high LDL who have not responded to other treatments.
Implementation of New American College of Cardiology/American Heart Association Prevention Guidelines
Guidelines for obesity, lifestyle management to reduce cardiovascular risk, cholesterol management and risk assessment were released in November based on systematic reviews of evidence initiated by the National Heart, Lung and Blood Institute (NHLBI). The guidelines will continue to be discussed and debated, and education programs will be developed to help physicians incorporate them into daily practice. The ACC and AHA, with support from NHLBI, will also start work on a guideline for the management of hypertension.
Rollout of Mitral Valve Clip
In October 2013, the U.S. Food and Drug Administration (FDA) approved a transcatheter procedure for treatment of prohibitive risk patients with severe degenerative mitral regurgitation, a heart disorder in which the mitral valve does not close properly when the heart pumps blood. This procedure offers a chance for treatment for these patients. An experienced heart team composed of an interventional cardiologist, cardiac surgeon and others will dictate use of this procedure. The ACC and the Society of Thoracic Surgeons (STS) will also add a mitral module to the National Cardiovascular Data Registry TVT Registry and begin reporting data in 2014.
Expanded Use of Novel Oral Anticoagulants in Patients With Atrial Fibrillation or Venous Thromboembolic Disease
These new medications began to get traction in the market in 2013 but still lagged behind warfarin, which was the only anticoagulant on the market for decades. Recent trial results have shown these new medications, which cost more per dose, improve outcomes compared to warfarin and do not require extensive monitoring or dietary/medication restrictions.
Results of Dual Antiplatelet Therapy Study (DAPT)
Results of this phase IV study are expected to be released in 2014 and may impact the duration of such treatment following coronary stenting across a wide spectrum of patients. Researchers are evaluating 12 months versus 30 months as the optimal duration of therapy in these patients.
Potential New Therapy for Refractory Hypertension
The results of a phase III trial of renal denervation for hypertension are expected in early 2014 and could eventually lead to FDA approval for a renal denervation device. With this procedure, a catheter is inserted into the renal artery to deliver radiofrequency pulses to reduce nerve signaling and lower blood pressure. If successful, it may be an alternative treatment for patients with refractory hypertension — those patients whose blood pressure remains elevated after treatment with three medications including a diuretic.
Continued Growth of Cardio-Oncology
This cardiology subspecialty is focused on the cardiovascular manifestations of cancer and complications of its treatment. It is offered at select hospitals across the country to help cancer patients maintain their heart health during and after treatment. Look for it to expand rapidly to more hospitals across the country.
For more information: www.cardiosource.org