May 18, 2012 (Paris, France) — Real-world stroke rates following transcatheter aortic-valve implantation (TAVI) are likely not as high as the PARTNER A trial first suggested, and a refined understanding of just when and how these are occurring should help bring rates down even further, researchers at EuroPCR 2012 told a packed session here today.

The rate of major stroke at 30 days was 3.8% in PARTNER A.

Dr Rutger-Jan Nuis (Erasmus ThoraxCenter, Rotterdam, the Netherlands) presented stroke data from 214 patients who'd undergone TAVI with the Medtronic CoreValve at the Erasmus ThoraxCenter. At six days, there were a total of 11 major strokes (5%), two minor strokes, and six transient ischemic attacks (TIAs). Importantly, he said, half of the strokes occurred during the procedure, but the remainder occurred two to six days later.

The major stroke rate of 5% — higher than that reported by others Thursday — may reflect the fact that the Rotterdam series includes all patients treated there, including the so-called "learning-curve" early cases.

A key predictive factor in the Rotterdam cohort was new-onset atrial fibrillation, which was the strongest predictor of stroke in multivariate analyses; five patients who developed AF, who'd been taking only aspirin and clopidogrel, went on to have a stroke.

"These findings indicate that improvements [in patient management] after TAVI are as important as if not more important than preventive measures during TAVI to reduce stroke," he said.

Separately, Dr Johan Bosmans (University Hospital Antwerp, Belgium) presented new details on the stroke data from the ADVANCE registry, also with the CoreValve, first reported earlier this year at ACC 2012. At 30 days, the stroke rate was 2.9%, rising to 4.5% by six months. Major strokes, however, were just 1.2% and 1.6%, respectively.

In terms of timing, a total of 14 major strokes in ADVANCE occurred during the procedure out to two days, while 15 (41%) occurred between two days and one month (34%), and four occurred between one and six months (25%).

Here, too, a history of atrial fibrillation was a key predictor of stroke post-TAVI, as was longer procedure duration and female gender.

Finally, Dr Holger Eggebrecht (Cardioangiological Center Bethanien, Frankfurt, Germany) presented a meta-analysis of 53 TAVI studies combining data on 10 037 patients. Both CoreValve and Sapien devices, deployed via a transfemoral, transapical, or subclavian route, were included.

According to Eggebrecht, the 30-day stroke/TIA rate was 3.3%, with a major stroke rate of 2.9%. At 12 months, that rate had risen to 5.2%, with the lowest stroke rates seen among patients undergoing transapical TAVI implantation.

Concern over stroke risk with TAVI has spurred development of distal-protection devices, designed to capture any debris set loose in the circulation during the implantation procedure. During discussion of the presentations today, speakers and moderators alike highlighted the need to think beyond protection devices, addressing, for example, better anticoagulation of patients both prior to and following their procedures, better management of hypertension and other risk factors, and ongoing involvement of neurologists both in TAVI research and clinically as part of patient screening and follow-up.

Nuis had no conflicts of interest. Bosmans disclosed being a proctor for Medtronic's CoreValve. Eggebrecht disclosed being a proctor for Medtronic/CoreValve and Edwards Lifesciences and receiving honoraria payments.


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