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Rapid adoption of TAVR has facilitated successive valve iterations designed to address remaining unmet needs, such as small valve delivery system profiles to accomodate female vasculature and methods to reduce paravalvular leak (PVL). The Evolut PRO System (Medtronic, Minneapolis, MN) includes the latest suprannular self-expanding TAV delivered via vessels ≥5.5 mm in diameter and includes a porcine pericardial wrap to provide enhanced sealing to help diminish the incidence of PVL. We reported 30-day mortality of 1.7%, disabling stroke of 1.7%, and > mild PVL of 0%. We report follow-up at 6 months.
The multicenter, non-randomized Evolut PRO Clinical Study enrolled 60 patients implanted with a 26- or 29-mm valve at 8 US sites. An independent Screening Committee confirmed patient eligibility and anatomical suitability. The valve can be delivered via a 16F-equivalent EnVeo InLine Sheath. An independent CEC adjudicated major adverse events by VARC-2 definitions and an independent echo core lab assessed valve hemodynamics.
Mean age was 83.3±7.2 y, 65% female, STS score of 6.4±3.9% and 81.7% were frail. From 1 to 6 months, 2 patients died (1 non-cardiovascular) for a 6-month mortality rate of 5.0%; and there were no more disabling strokes (6-month rate of 1.7%) or pacemaker implants (11.7%). Mean AV gradient was 6.8±2.2 mmHg and the mean effective orifice area was 2.0±0.5 cm2 at 6 months. PVL data is in Figure.
The Evolut PRO TAV, continues to show excellent hemodynamics and low mortality at 6 months. Longer-term data in more patients is needed.
STRUCTURAL: Valvular Disease: Aortic