Heart Failure: Next-Gen VADs Fuel Optimism Amid Challenges

Although near-term challenges have slowed growth in the market for left ventricular assist devices (LVADs), companies are developing new, less invasive VADs with improved pump designs to further improve patient outcomes and allow for a wider application of the therapy in treating heart failure. These next-generation VADs are fueling long-term optimism in the market for mechanical circulatory support, which remains one of the more attractive opportunities in the cardiovascular space.

Heart failure (HF) remains one of the most challenging and costly health problems today, affecting more than 20 million patients worldwide, and causing more than seven million deaths per year. In the US alone, the number of people with HF is projected to increase from five million in 2012 to eight million in 2030, according to the American Heart Association (AHA), driven by an aging population and increasing prevalence of conditions that contribute to this degenerative, progressive disease, including ischemic heart disease, hypertension, and diabetes. HF has become a major burden on health care systems and its economic impact is staggering. The annual direct and indirect costs of HF are projected to more than double over the next 20 years, increasing from $31 billion to $70 billion, according to 2014 AHA estimates. Much of that cost is due to the frequent hospitalizations typical of HF patients, who seek symptomatic relief from cardiorenal syndrome, a debilitating condition that causes fluid retention and shortness of breath. In fact, HF is the leading cause of hospitalization in patients over 65 years of age in the US, and preventing re-hospitalization of these patients has become a primary goal of hospitals, particularly since the Centers for Medicare and Medicaid Services (CMS) began financially penalizing hospitals with excess HF admissions. (See Also see "Heart Failure Devices: Raising Roadblocks To Readmission" - Medtech Insight, 27 January, 2012..)

Given the enormity of this problem, there is an urgent need to find innovative ways to treat HF earlier in the disease process to help slow, and potentially reverse the course of this debilitating and deadly chronic disease. Current treatment options for HF include pharmacological therapy, cardiac resynchronization therapy (CRT), mechanical circulatory assist, and heart transplantation. Moreover, there are a variety of device-based solutions under development aimed at improving or reducing the incidence of HF in patients who fall into the “treatment gap” for heart failure. This gap includes New York Heart Association (NYHA) Class III and ambulatory Class IV patients who are too sick to be on medical therapy alone, have failed CRT (if indicated), but are not so sick that they require inotropic support, mechanical circulatory support, or a heart transplant

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