PARIS — A device aimed at preventing emboli from transcatheter aortic valve replacement (TAVR) from reaching the brain appeared safe with a reduction in stroke by some measures, a pooled analysis suggests.
Overall rates of in-hospital major adverse cardiovascular and cerebrovascular events were similar between patients who were successfully implanted with the TriGuard shielding device and those who went without (18.2% versus 24.1%, P=0.44).
There was also no difference in cognitive worsening (28% versus 35%, P=0.38) as per screening with the Montreal Cognitive Assessment, Alexandra J. Lansky, MD, of Yale University School of Medicine in New Haven, Conn., reported here at the EuroPCR meeting.
Even so, VARC 2-defined strokes and new neurologic deficits by systematic NIH Stroke Scale assessment and brain imaging were noticeably absent in the TriGuard cohort (versus 6% [P=0.05] and 19% [P=0.001] of controls, respectively).
Diffusion-weighted MRI 4 days after TAVR turned up a high incidence of central nervous system infarctions in both groups but fewer in the TriGuard group (72% versus 92% for controls, P=0.008). There was a 40% reduction in total lesion volume as well (101.4 mm3 versus 174 mm3, P=0.04), Lansky told the audience during the late-breaking trial session.
Responding to concerns from the panel on why infarctions — though less frequent — was nonetheless still evident in the TriGuard patients, the presenter said: “Ultimately, stroke is never going to be completely eliminated, because there are several courses of stroke.”
TriGuard consists of a single-wire nitinol frame and mesh filter. After operators deliver it through a femoral approach — positioning it across all three cerebral vessels — it is held in place by a stabilizer without interfering with blood flow.
Lansky’s pooled analysis included two registry studies and one randomized trial (DEFLECT III). There were 142 TAVR recipients in all.
Citing prior studies, Lansky estimated that stroke occurred after 15% to 28% of TAVR procedures.
When the discussion turned to the learning curve of TriGuard usage, the researcher commented that five patients were excluded from the current analysis after operators failed to achieve full anatomical coverage with the device.
That apparently in and of itself marked some improvement: “As we went from DEFLECT I to DEFLECT III, the number of patients who didn’t have full coverage went down. I think clearly there’s a learning curve with the device,” she stated.
Lansky noted that the ongoing REFLECT randomized clinical trial is designed to confirm these results.
Lansky reported receiving institutional reserach support from Keystone Heart.
Lansky A, et al “A patient level pooled analysis of neuroprotection with the TriGuard embolic deflection device compared to unprotected transcatheter aortic valve replacement” EuroPCR 2016.