TAVR Chugging Along at 5 Years in SURTAVI Trial

Researchers keeping an eye on the long-term outcomes of people undergoing transcatheter aortic valve replacement (TAVR) reported encouraging results in both clinical and economic terms, according to two reports from the Transcatheter Cardiovascular Therapeutics (TCT) meeting.

The 5-year incidence of all-cause mortality or disabling stroke among people in the SURTAVI trial was no different between TAVR and surgical groups (31.3% vs 30.8%; HR 1.02, 95% CI 0.85-1.22), with no catch-up by either group between 2 and 5 years, according to Nicolas Van Mieghem, MD, PhD, of Erasmus University Medical Center in Rotterdam, The Netherlands.

TAVR outperformed surgery with respect to core lab-assessed hemodynamics. However, it was associated with more paravalvular leak (30.1% vs 3.4%), reinterventions (3.5% vs 1.9%), and permanent pacemakers needed (35.8% vs 14.6%) over 5 years, Van Mieghem told the audience at the TCT meeting held in Orlando and broadcast online.

Between TAVR and surgical groups, rates of valve endocarditis (1.0% vs 1.8%) and valve thrombosis (0.5% vs 0.4%) were similarly low.

Details of SURTAVI have been previously reported along with its 2-year outcomes.

As the trial was conducted from 2012 to 2016, investigators had intermediate-risk patients undergo TAVR with the early CoreValve in the majority of cases, with 16% getting the subsequent-generation Evolut R. Since then, the device has evolved into the Evolut Pro and its even-newer version, the Evolut PRO+.

With a different valve studied in a lower-risk patient population, the PARTNER 3 trial recently suggested that TAVR could catch up to surgical aortic valve replacement (SAVR) in deaths and strokes by as early as 2 years.

Yet the question of cost-effectiveness could still favor the transcatheter procedure in low-risk patients, according to a separate presentation at TCT.

In PARTNER 3, Medicare claims revealed TAVR and SAVR groups shared similar index hospitalization costs:

• Total: $47,196 vs $46,606 (P=0.59)
• Procedural cost: $37,370 vs $18,327
• Non-procedural cost (e.g., ICU stay): $7,174 vs $23,578
• Doctor’s fees: $2,652 vs $2,702

TAVR’s non-significant advantage in lower 2-year follow-up costs ($19,638 vs $22,258, P=0.13) left total costs comparable between groups, reported David Cohen, MD, MSc, of Cardiovascular Research Foundation and St. Francis Hospital and Heart Center in Roslyn, New York.

Cohen said that assuming no difference in survival or costs beyond 2 years, it is 84% likely that TAVR is the dominant choice — both in reducing costs and increasing survival compared with SAVR — and 95% likely that its incremental cost-effectiveness ratio is under $50,000 per quality-adjusted life-year.

The assumption of no excess in late mortality after TAVR was key.

Thus, longer-term follow-up is still needed despite the reassurance of this report, according to Luca Testa, MD, PhD, of IRCCS Policinico San Donato in Milan, Italy, speaking as a panelist during a TCT press conference.

PARTNER 3 was conducted in 2016-2017 with the TAVR arm receiving the Sapien 3 balloon-expandable device.

“Given the importance of long-term outcomes in these projections, 10-year follow-up is ongoing and will ultimately determine the preferred treatment strategy for such patients from both a clinical and economic perspective,” Cohen said.

He argued that TAVR is a “financial win” despite the general sentiment that TAVR is a money-loser for hospitals.

“I don’t know how hospitals are going to sustain all these patients” when the valve alone costs $32,000, said panelist Keith Allen, MD, of Mid America Heart and Lung Surgeons in Kansas City, Missouri. There, the fixed Diagnostic-Related Group payment for TAVR is only around $36,000, he noted.

It’s the high-risk patients that bring more money to the hospital, Allen added.

Cohen noted that a hospital may get a rebate that brings the cost of a $32,500 TAVR valve down to $25,000, but acknowledged that is still a hefty price. Based on the experience in Europe, he predicted that valve prices should get lower over time.

According to Allen, however, Medicare reimbursement for TAVR will only decrease in line with the trend of shorter stays in hospital after the procedure.