In late 2009, Aspirus Heart & Vascular Institute in Wausau, Wis., was inspired to develop a dedicated heart valve center, in conjunction with a Valve Clinic, by both clinical and economic motivations. Since that time, the provider has seen an increase in referrals for surgical valve candidates, while also building in-house expertise of the complex disease states.
Due to decreasing reimbursement across cardiovascular specialties, some administrators may be cautious about investing in a new service line. But forward-thinking facilities are discovering that the risk of placing resources into treating this growing valve disease patient population may pay off, especially if new percutaneous therapies become FDA approved. Aspirus physicians saw three reasons to begin the endeavor.
First, there was an underserved patient population, for which percutaneous options were emerging. "We realized the potential for percutaneous interventions in the structural heart valve patients, especially with new therapies for valvular heart disease, based on the experiences of our European colleagues," says German Larrain, MD, co-director of the Valve Clinic, who is an interventional cardiologist.
For several years, "percutaneous aortic valves have been successfully implanted in Europe on a widespread scale," he says, as the first transcatheter aortic valve replacement (TAVR) system was granted a CE mark in 2007 (Sapien, Edwards Lifesciences). Since then, results of both cohorts of the U.S.-based PARTNER trial have demonstrated successful outcomes in inoperable patients with aortic stenosis and patients at high surgical risk. Currently, the FDA is reviewing the Sapien device for inoperable patients with aortic stenosis, after a panel recommended its approval in July, and a second TAVR system is conducting its U.S.-based trial (CoreValve, Medtronic).
|Economic Breakdown of Establishing
a Dedicated Valve Clinic
|Anticipated Revenue Collected:||$830,036.59|
|Source: Aspirus Heart & Vascular Institute|
Also, mitral valve disease is equally underserved for patients at high risk for surgery. The mitral valve clip (MitraClip, Abbott Vascular), which can be used as an alternative to open-heart surgery for certain patients with mitral regurgitation, received the CE mark in 2008, but is still an investigative device in the U.S. Abbott applied for FDA approval in March 2010. By the conclusion of 2010, approximately 2,000 MitraClip implants had been performed globally. The two-year results of EVEREST II, presented at ACC.11, showed durability of outcomes for the device and control groups using the MitraClip or surgical repair for patients with mitral regurgitation.
"Secondly, from a business perspective, we saw that coronary artery disease has leveled off and the volume of PCI and cardiac surgery is decreasing across the U.S.," Larrain continues. "Everybody expects small growth in cardiovascular service line business, but mainly in the area of valvular heart disease." In fact, market researcher, Millennium Research Group, predicted that the European TAVR market alone will reach a value of $560 million by 2015.
Finally, practice makes perfect. To best serve this complex population, it may behoove practitioners to become specialists in these disease subsets. "We have a good understanding of how to treat coronary artery disease, but we do not understand valvular disease as well," Larrain explains. "It's a lot more complex, requiring more finesse to diagnose and treat appropriately. With new technologies coming, we have a clinical and a business opportunity, but we must first be at the top of our game when it comes to diagnosing and treating these patients."
After formulating this idea, Larrain and his partners met with surgeons and administration to present the concept. A dedicated valve center requires "a significant investment in time and resources," says Larrain, adding that the immediate buy-in from his cardiothoracic surgeon partner, Ronald H. Miles, MD, was "helpful because he recognized that treating valvular disease is a collaborative effort."
The administration decided to invest in the development of the Valve Clinic by supporting additional physician training, dedicating a few nurses to the clinic on a part-time basis and marketing the program to the community and referring physicians.
How the Aspirus Valve Clinic works:
- The clinic takes