DENVER, CO — Although procedural costs remain substantially higher, transcatheter aortic-valve replacement (TAVR) with the Sapien XT or Sapien 3 valve (Edwards Lifesciences) provides greater quality-adjusted life expectancy and lower long-term costs for intermediate-risk patients than surgical AVR (SAVR), economic analyses show[1].
TAVR is an “economically dominant strategy” for patients with severe aortic stenosis and intermediate surgical risk similar to those enrolled in the PARTNER 2A and Sapien 3 trials, Dr David J Cohen (Saint Luke’s Mid America Heart Institute, Kansas City, MO) reported at TCT 2017.
“These findings suggest that TAVR should be the preferred strategy for such patients, based on both clinical and economic considerations.”
Last year, the US Food and Drug Administration expanded the indications for the Sapien XT and Sapien 3 valves to include intermediate-risk patients.
Prior studies have shown that TAVR is cost-effective but not cost saving compared with SAVR for patients at high surgical risk, but how it stacks up in intermediate-risk patients was unknown.
To determine this, Cohen and his colleagues conducted two analyses comparing the surgical arm from PARTNER 2A (n=944) with its TAVR arm (n= 994) and the TAVR arm from Sapien 3 (n=1077).
Trial patients were linked with Medicare claims data and index hospitalization costs calculated using a combination of resource-based accounting for the two procedures and claims data. All other costs (follow-up hospitalizations, MD services, outpatient testing, custodial care) were based directly on Medicare payments derived from claims.
Procedural costs for TAVR with the Sapien XT valve were about $22,000 more than for SAVR ($38,548 vs $16,465), driven by the much higher valve costs, Cohen said.
On the other hand, nonprocedural costs were about $18,000 lower with TAVR than SAVR ($19,417 vs $37,409), driven by significant reductions in length of stay (6.4 vs 10.9 days), especially costly ICU stays (2.4 vs 4.6 days).
Physician costs were lower with TAVR ($3827 vs $5421), but when all index hospitalization costs were combined, TAVR was still $2888 more expensive per patient than surgery (P=0.014).
Over the next 2 years of follow-up, however, TAVR with the Sapien XT valve was associated with significant reductions in the number of hospital days and rehabilitation/skilled-nursing facility days. This resulted in substantial cost savings, particularly in the first 6 months, with 2-year follow-up costs coming in $9304 lower with TAVR than surgery (P<0.001).
When follow-up costs were combined with the initial treatment costs, the total 2-year cost for TAVR was lower by more than $6000 per patient than SAVR ( $107,716 vs $114,132; P=0.01).
Lifetime cost-effectiveness analyses also showed that TAVR added 0.15 quality-adjusted life-years (QALY) per patient.
Newer Valve, Better Result$
Results using the Sapien 3 valve and more contemporary care patterns were even more favorable for TAVR, Cohen noted.
Although procedural costs were again higher for TAVR than for SAVR ($37,776 vs $16,502), total index hospitalization costs were lower with TAVR ($54,256 vs $58,410), thanks in large part to a 6.5-day reduction in hospital length of stay and 3.5-day reduction in ICU stay.
Medicare claims available only through 1 year of follow-up showed follow-up costs were also lower with TAVR than with surgery ($26,861 vs $38,238; P<0.001), driven by significant declines of 27% for cardiac hospitalizations, 18% for noncardiac hospitalizations, and a whopping 53% for rehabilitation/skilled-nursing facility days.
When follow-up and index hospitalization costs were combined, the total 1-year cost for TAVR with the Sapien 3 valve was $15,511 lower per patient than with SAVR ($80,977 vs $96,489; P<0.001).
This time around, TAVR also added 0.27 QALY per patient compared with SAVR.
But Who Benefits?
After seeing the results at a press briefing, moderator Dr Ori Ben-Yehuda (Cardiovascular Research Foundation, New York, NY) said, “My personal reaction is sort of, wow! It’s good news for patients, it’s good news for the economy, and it’s good news for us taxpayers.”
During the formal presentation, however, panelist Dr Hemal Gada (Rutgers Robert Wood Johnson Medical Group, New Brunswick, NJ) remarked, “The price of the valve being what it is and our ability to make this procedure more efficient has maybe led to this shooting-ourselves-in-the-foot template, schematic, where reimbursements may go down in a fee-for-service paradigm as exists right now.”
He continued, “Can you envision an alternate reimbursement model that will actually reimburse this procedure more fairly?”
Cohen responded, “Being the United States, we’re kind of stuck with this, but I will say that if we were in a bundled-payment model where 90-day and even 6-month payments were accounted for; hospitals being paid based on that, TAVR would look great to a hospital.”
Cohen told theheart.org | Medscape Cardiology that hospitals typically make less money on TAVR than SAVR but that regional variation exists in terms of reimbursement.
“If you live on the coasts, they do fine because the reimbursement is much higher, the valve costs the same, but if you live in the middle of the country, they barely break even because the reimbursement in many cases is not very far different from the price of the valve. Again, it is a particular anomaly within the Medicare reimbursement system,” he said.
Dr Duane Pinto (Beth Israel Deaconess Medical Center, Boston, MA) said in an interview that it’s always impressive to see an economically dominant strategy that results in cost savings and improves patient outcomes, but the results will not change how much hospitals make off TAVR procedures.
“Maybe I’m cynical, but I’m not sure they’re looking at saving the healthcare system money; but the smart hospital administrator will see that throughput is improved, and this is the way that aortic-valve replacement is going. If you looked at a global budget for a hospital and had better throughput and filled those beds with additional paying patients, it’s useful.”
As to whether surgeons might frown upon the findings, Cohen told reporters that fortunately, surgeons are still involved in all of these procedures because of the Medicare mandate that all TAVR patients be reviewed by a heart team.
What’s unclear is how the potential shift of TAVR toward lower-risk patients may affect the market, he acknowledged.
“Obviously the most important piece of data on the low-risk population won’t be known for many years, which is the durability,” Cohen said. “It’s hard to imagine that we will not have good outcomes in both TAVR and surgery for those patients in the short term.”
On whether or not the same cost saving will be seen in low-risk patients, Dr Michael Mack (Baylor Health Care System, Dallas, TX) told theheart.org | Medscape Cardiology, “We may not, because probably there’s better recovery and less resource utilization for surgery in younger, lower-risk patients. So I don’t think we can extrapolate that for sure.”
Following the formal presentation, Prof Patrick Serruys (Imperial College London, UK) also observed that the approval of several TAVR valves currently pending FDA clearance could further lower the price of TAVR and “destabilize this cost-effectiveness analysis.”
PARTNER 2A and S3i trials and the economic analyses were funded by research grants from Edwards Lifesciences. Cohen is a consultant to Edwards. Mack reported grant support/research contract with Medtronic, Edwards, and Abbott Vascular. Serruys reported grant support/research contract with Biosensors; and consultant fees, honoraria, or speaker’s bureau participation with Abbott Vascular, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sino Medical Sciences Technology, Société Europa Digital Publishing, Stentys France, Svelte Medical Systems, St Jude Medical, Volcano Corp, Qualmed, and Xeltis.
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