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 impact can be sizable for other departments such as radiology, whose physicians play a key role with cardiac surgeons and interventional cardiologists as part of the heart team in a case. In addition, many TAVR patients have comorbidities such as heart failure or chronic obstructive pulmonary disease that require care from cardiologists and pulmonologists.
“The number of ancillary testing has gone up tremendously because of these patients coming in for a workup for TAVR,” Szeto says. While quantifying the coattail effect is challenging, he adds that the center has data that demonstrate how TAVR has created downstream revenue for other departments.
Patients who become comfortable with their care in a TAVR center may prefer to have other healthcare needs met at that hospital as well. Based on the patient characteristics in TAVR pivotal trials, these patients are likely to be quite elderly and sick. The mean age in PARTNER (Placement of AoRtic TraNscathetER Valves), the pivotal trial for the Sapien valve, was 84 years old and more than three-quarters of the participants had coronary artery disease. In the Core-Valve high-risk trial, the mean age was 83.
“Once the patients are followed in our valve center, other medical conditions may develop later and require medical attention and intervention,” Szeto says. “They may develop coronary disease or other valvular disease that require interventional or surgical therapy.”
Enough to be proficient?
The demand for TAVR is likely to remain strong for some time. As Brennan points out, degenerative aortic stenosis is a disease of the aged and many generations to come may be beneficiaries of the technology. Still, some physicians raise concerns about sufficient volume to ensure good outcomes. Particularly in regions with a relatively high concentration of TAVR, they question if there are enough patients for surgeons to develop and maintain expertise.
Arthur M. Feldman, MD, PhD, executive dean, and heart surgeon Verdi J. DiSesa, MD, PhD, both of Temple University School of Medicine in Philadelphia, calculated that in 2014, six of the nine hospitals in Philadelphia County with open heart surgery programs also offered TAVR (JAMA online May 5, 2014). That translated into 3.88 TAVR programs per million population. Only two hospitals had annual SAVR volumes in excess of 200, which they considered a surrogate measure for TAVR.
“It is going to be very difficult for the small centers to ramp up effectively to get the requisite volumes that they can both gain and maintain quality outcomes,” Feldman says.
In their study, Feldman and DiSesa identified 12 TAVR programs in the greater Philadelphia metro region, which includes Delaware and parts of New Jersey. Szeto estimated the count at 14 or 15. Like the Temple team, he had doubts that so many hospitals could have sufficient volumes for all of them to rise from average to expert.
Low volumes and inefficient processes in a TAVR program could be a drag on finances for the entire valve center. Poor results could compromise its public standing and accreditation. Nonetheless, “No hospital and no physician wants to be perceived as not doing TAVR because it makes them seem less capable than the institutions that are doing TAVR,” Feldman observes. “If you are not good enough to do TAVR, might you also not be good enough to do bypass surgery or electrophysiology cases or what have you?”
“If you run a TAVR program poorly, there will be negative financial implications for your institution,” Szeto acknowledges. “However, if you are going to be a comprehensive cardiac program in 2014, you have to offer TAVR. I don’t see how you cannot and stay competitive.”
In contrast to Philadelphia, Feldman and Di-Sesa found that in the New York City boroughs, there were 0.96 TAVR programs per million and the smallest TAVR program reported an average 217 SAVRs annually. They credited consolidation and New York’s certificate-of-need system, which gives the state oversight on equipment acquisitions, for facilitating collaboration.
Regions such as Philadelphia, where consolidation hasn’t occurred, are hampered by federal regulations such as anti-kickback laws and Stark rules that are designed to protect patients from physicians and hospitals who engage in deals for financial gain. The unintended consequence is that independent hospitals can’t work together.
His solution? A federal waiver that allows independent hospitals to partner in a revenue-sharing regional center of excellence. “If two hospitals are getting together to do a service, and by getting together they will improve outcomes and lower costs,” then they should qualify for the waiver, he says. “[It] is what we are all trying to do, so value can go up.”