AT TCT 2017
DENVER (FRONTLINE MEDICAL NEWS) – A formal cost-effectiveness analysis indicates that transcatheter aortic valve replacement (TAVR) is substantially more cost effective than surgical valve replacement in patients at intermediate surgical risk similar to those enrolled in the landmark PARTNER 2 trial.
The analysis demonstrated that over a 1- and 2-year follow-up period, as well as with projected lifetime follow-up, TAVR entails both lower long-term costs and greater quality-adjusted life expectancy, David J. Cohen, MD , reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting.
“These findings, taken together with the clinical data we now have, suggest that TAVR should be the preferred strategy for such patients, based on both clinical and economic considerations,” said Dr. Cohen, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo.
His two-part, patient-level economic analysis examined data from nearly 2,000 participants in the PARTNER 2A randomized trial comparing TAVR, using the Sapien XT valve, with surgical aortic valve replacement (SAVR), as well as the experience with the current-generation Sapien 3 TAVR valve in 1,077 intermediate–surgical risk TAVR patients in the S3i registry. The analysis utilized Medicare claims data on the costs of the index hospitalization and follow-up care.
In PARTNER 2A, the average total cost of the index hospitalization for valve replacement was $61,433 with TAVR. That was just $2,888 more than the SAVR hospitalization, despite the far higher acquisition cost of the Sapien 3 valve, which was roughly $32,500, compared with $5,000 for the surgical valve. Most of this additional cost of the TAVR valve was counterbalanced by TAVR’s 2-hour shorter procedural duration, the 6.4-day average length of stay, compared with 10.9 days for SAVR, and the fact that TAVR patients spent only 2.4 days in intensive care while SAVR patients averaged 4.6 days, Dr. Cohen explained at the meeting sponsored by the Cardiovascular Research Foundation.
During 24 months of postdischarge follow-up in the PARTNER 2A trial, SAVR patients racked up an average of $9,303 more in costs than TAVR patients. This was mainly because of their much higher rates of rehospitalization and time spent in skilled nursing facilities and rehabilitation centers, mainly during months 2-6 post discharge. The result was that 2-year total costs including the index hospitalization averaged $107,716 per TAVR patient and $114,132 per SAVR patient.
“One of the really remarkable findings of this study was what happened during follow-up,” the cardiologist observed.
Extrapolating to projected remaining lifetime years, TAVR using the Sapien XT valve resulted in a cost savings of $7,949 per patient and a 0.15-year increase in quality-adjusted life expectancy compared with SAVR.
But since the time of PARTNER 2A, the Sapien XT valve has been replaced by the updated Sapien 3 valve. The analysis of the S3i registry showed that the economic dominance of TAVR over SAVR was even greater owing to improved valve technology and contemporary care patterns. For this analysis, because there has been no randomized trial of TAVR with the Sapien 3 valve versus SAVR, patients in the SAVR of arm of PARTNER 2A served as the comparison group.
The cost of the index hospitalization was more than $4,000 less with TAVR in the S3i registry than with SAVR. The total cost of TAVR through 1 year of follow-up averaged $80,977, which was $15,511 less than the $96,489 for SAVR. The cost post discharge out to 1 year was more than $11,000 less per TAVR patient, driven by sharply lower rates of both cardiovascular and noncardiovascular hospitalizations as well as a greater than 50% reduction in days spent in rehab centers and skilled nursing facilities, compared with SAVR patients.
Projected over estimated remaining years of life, TAVR with the Sapien 3 valve yielded a cost savings of $9,692 per patient compared with SAVR, as well as a 0.27-year gain in quality-adjusted life-years.
Eighty-eight percent of patients in the S3i registry received their Sapien 3 valve via a transfemoral approach. When Dr. Cohen and his coinvestigators compared their costs and clinical outcomes to the subset of PARTNER 2A TAVR patients who got the Sapien XT valve transfemorally, the outcomes were “virtually identical,” he said.
“These findings are reassuring with regard to the S3i results and also suggest that the primary mechanism of benefit of the Sapien 3 valve over the XT valve is its lower profile, which allows roughly 90% of patients to be treated via a transfemoral approach,” according to Dr. Cohen.
He predicted the new cost-effectiveness findings will not substantially increase patient demand for TAVR, which is already high.
“By far what’s driving patients to TAVR today are the quality of life advantages. They love the idea of recovering quickly,” he said.
Michael Mack, MD , commented that this analysis probably underestimates the true cost advantage of TAVR by a fair amount, since the average hospital length of stay for TAVR patients in PARTNER 2A was 6.4 days.
“We now know that half of U.S. TAVR patients in many centers go home the day after the procedure, so you would expect that TAVR would look even more favorable based on current practice,” said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and chairman of the Heart Hospital Baylor Plano (Tex.) Research Center.
Session moderator Patrick W. Serruys, MD , of Imperial College, London, observed that the cost differential between TAVR and SAVR will grow even larger once the sky-high cost of TAVR valves comes down. He predicted that’s likely to happen as a result of increased competition once a third valve receives marketing approval, just as occurred after a third drug-eluting stent hit the market.
Several physicians grumbled about the unfairness of current reimbursement for TAVR, which in effect penalizes hospitals. Dr. Cohen said that situation will change.
“I think the future of health care financing in the U.S. is bundled payment and accountable care organizations. In the setting of bundled payment for a 6-month period or even for 90 days, TAVR would look fantastic to a hospital or an health maintenance organization due to avoidance of rehospitalizations and rehabilitation and skilled nursing facility stays,” the cardiologist said.
The PARTNER 2A trial, the S3i registry, and the cost-effectiveness analysis were funded by Edwards Lifesciences. Dr. Cohen reported receiving research funding from and serving as a consultant to Edwards Lifesciences and other device companies.