With 2013 in full swing, we’ve taken a step back to review the major CV technology stories of 2012. From devices gaining FDA approval to therapies demonstrating paradigm-shifting potential, 2012 was a year of significant innovation across CV services. To help CV leaders nationwide distill the most impactful new research, data, and FDA approvals, we’ve broken down the four top stories of 2012 and what you need to know in 2013.
Top cardiovascular technology trends of 2012
On November 20, the FDA voted to approve the HeartWare Ventricular Assist Device (HVAD) for use in patients at risk of end-stage left ventricular heart failure awaiting transplant. The HeartWare system has been CE Marked in Europe since 2009 and consists of a small LVAD pump that can be fully implanted in the pericardial space without requiring further surgical incisions in the abdomen.
Until now, Thoratec’s HeartMate II has monopolized this market. However, the smaller, lighter, and magnetically levitated HeartWare HVAD provides hospitals with a new alternative to HeartMate II for bridge to transplant (BTT) patients.
HeartWare HVAD receives FDA approval
On September 29, 2011, the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) released updated guidelines for the management and treatment of peripheral artery disease (PAD), a condition that affects approximately eight million Americans, 20% of whom are 65 years of age or older. Updated for the first time since their initial release in 2005, these guidelines aim to provide cardiologists, vascular medicine specialists and surgeons, interventional radiologists, pulmonologists, and primary care physicians (PCPs) with a road map for effective management and treatment of PAD patients, many of whom are asymptomatic.
To provide this road map, members of ACCF, AHA, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Vascular Medicine, and Society for Vascular Surgery reviewed recent, evidence-based clinical trials and other data to develop these updated recommendations. Specifically, findings of the Reduction of Atherothrombosis for Continued Health (REACH) registry showed high rates of hospitalization for PAD patients; hospitalization rates for asymptomatic and symptomatic patients in the study were 23% and 31%, respectively.
Moreover, both asymptomatic and symptomatic PAD patients enrolled in the study were associated with high hospitalization costs: While asymptomatic individuals had an average two-year hospitalization cost of $7,445, symptomatic patients displayed an average two-year hospitalization cost of $11,693.
Updated PAD guidelines highlight need to improve diagnostics treatment disease management