The number of transcatheter aortic valve replacement (TAVR) procedures in the U.S. has been growing with FDA approval of two devices and ongoing clinical trials evaluating other new technologies. Hospitals, which generally lose money on TAVR, reap rewards beyond status for having these programs. But with so many programs competing for patients, some markets may be on slippery footing.
No slowdown in sight
If you are a heart valve center in the U.S., these statistics forecast a busy future. Demand is high and growing, especially among the elderly. By the Centers for Disease Control and Prevention’s reckoning, the number of heart valve procedures across the U.S. rose from 82,826 hospital discharges in 2000 to 102,543 in 2010, with more than half of procedures in 2010 involving patients 65 years old and older. Costs followed suit, with mean inflation-adjusted cost per hospitalization jumping from $42,003 to $52,442 over the same period.
Preliminary data presented at the annual meeting of the Society of Thoracic Surgeons in early 2014 suggest the trajectory has continued upward with the introduction of TAVR possibly fueling not only TAVR volumes but also volumes for surgical aortic valve replacement (SAVR). Presenter James M. Brennan, MD, MPH, of Duke University Medical Center in Durham, N.C., reported that TAVR case volume spiked from 910 to 5,000 within a year of FDA approval in late 2011 of Edwards Lifesciences’ Sapien TAVR device for inoperable patients with severe aortic stenosis.
The FDA later approved the Sapien device for high-risk patients in 2012, and in 2014 cleared the way for Medronic’s CoreValve system for extremely high-risk patients.
SAVR case volume also shot upward at the 230 TAVR centers in the Brennan team’s analysis, from 17,407 near the time of Sapien’s market approval in 2011 to approximately 24,000 in 2012. The 571 centers that did not offer TAVR also experienced modest gains, from 19,460 to slightly more than 20,000. The analysis used data from the Transcatheter Valve Therapeutics registry.
Part of the spike is likely due to pent-up demand. A 2011 analysis found only 40 percent of patients with severe aortic stenosis who were referred to a cardiothoracic surgeon underwent SAVR, despite three in four being symptomatic (J Heart Valve Dis 2011; 20: 284-291). The most common reason for not being treated surgically was high operative risk.
“We see this clinically,” Brennan says. “There is a large group of patients who have not been operated now coming through who have been sent by the primary care office or are referring themselves in for treatment.” But not all qualify as appropriate candidates for TAVR, and those who don’t because their risk profile is moderate or low then may be counseled to undergo SAVR instead.
A loss leader
In reality, TAVR puts a strain on a hospital’s finances, at least if it is measured solely by the index procedure. The valve itself accounts for much of the cost. The Hospital at the University of Pennsylvania in Philadelphia, for instance, calculated that $32,500 of the $44,101 total direct cost for a TAVR in 2012 went to paying for the device.
“When we first started this, we tracked our ‘profitability’ by just looking at index TAVR, and it was clear early on that it was a money loser,” says Wilson Y. Szeto, MD, surgical director of transcatheter cardio-aortic therapies at the University of Pennsylvania Medical Center. The center found opportunities to shave costs, such as minimizing sedation practices, efficiently using the hybrid operating room and intensive care unit and reducing length of stay for some patients. “We have reduced cost in both an appropriate and efficient manner in order to make TAVR financially viable. Despite these measures, the margin with TAVR is still not as favorable as with other types of cardiac surgery.”
SAVR, in essence, subsidizes TAVR because it offers both a high case volume and high profits, potentially providing generous contribution margins for a hospital. At Penn, the average cost per case of a valve surgery was about triple the average of $12,075 for all cardiac procedures, according to an analysis presented by Szeto at the American Association for Thoracic Surgery meeting in 2013. SAVR cases grew from about 400 to 500 between launch of the TAVR program as a trial participant in 2008 and 2011, and valve cases as a whole approached 1,000 in 2012.
But TAVR pays back in other ways besides being a magnet for valve referrals. TAVR’s downstream