Patrice Wendling

May 30, 2017

PARIS, FRANCE — Stroke rates at 30 days were lower following transcatheter aortic-valve implantation (TAVI) than surgical valve replacement in a prespecified neurological SURTAVI substudy[1].

Among the intermediate-risk patients, the all-stroke rate was 3.3% in the TAVI group and 5.4% in the surgery group at 30 days (P=0.031), with no difference in rates between groups at 2 years (6.3% vs 8.0%; P=0.143).

Rates of nondisabling strokes were also similar between groups at 30 days and 2 years.

The difference in disabling stroke at 30 days, however, just missed statistical significance in favor of TAVI (1.2% vs 2.4%; P=0.057), study author Dr A Pieter Kappetein (Erasmus Medical Center, Rotterdam, the Netherlands) reported in a late-breaking trial session here at EuroPCR 2017.

"The incidence of early stroke was significantly lower in patients after TAVI than after surgical AVR," he said. "This is the first time that we can show this."

The main findings of the SURTAVI trial, reported earlier this year by heartwire from Medscape, showed TAVI with the self-expanding CoreValve or Evolut R devices (both Medtronic) was noninferior to surgery for all-cause mortality or disabling stroke (2.6% vs 4.5%) at 2 years.

For the present analysis, an independent clinical-event committee adjudicated all neurological events, including stroke and encephalopathy, using the Valve Academic Research Consortium 2 (VARC-2) definitions. In all, 28 TAVI-treated patients (mean age 78.5 years) and 43 surgically treated patients (mean age 80.3 years) had an early stroke.

Most disabling strokes were clustered around the procedure in the TAVI group, with only one occurring 24 days postimplant, whereas these events occurred on days 4, 5, 6, and beyond in the surgery group, Kappetein noted.

Try as they might, the researchers could not find baseline or procedural differences between the groups that would help identify those at higher risk of early stroke. Variables included but were not limited to age, sex, Society of Thoracic Surgeons (STS) risk of mortality, diabetes, history of hypertension, need for revascularization, or more than one valve implanted.

"We were not able to show a difference in any groups, so actually the risk is for every patient that we treat with TAVI or surgical AVR," Kappetein said during a press briefing. "It's difficult to prevent it and to identify which patients will suffer a stroke and which will not."

At 1 year, all-cause mortality was similar in TAVI and surgical patients with an early stroke (17.9% vs 14.6%) or early encephalopathy (22.1% vs 16.5%; both log-rank P=0.61).

Patients suffering an early stroke, regardless of treatment group, spent nearly twice as long in the ICU and hospital and were more likely to die in the hospital or be discharged to a skilled nursing facility or rehabilitation clinic.

As TAVI continues to move into lower-risk populations, an understanding of the relative risk for neurological complications and their clinical consequences following TAVI or surgery is critical, Kappetein said. One takeaway is that the heart team should consider TAVI if any calcium is present in the ascending aorta.

"If you see a couple of spots of calcium in the ascending aorta, I think what these data show is that TAVI might be the preferred option," even if the patient is younger "and could otherwise undergo surgery quite well."

SURTAVI was funded by Medtronic. Kappetein reported institutional grant/research support from Medtronic.

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