Author + information
- Ian Meredith1,
- Stephen Brecker2,
- Sanjeevan Pasupati3,
- Daniel Blackman4,
- Tony Walton5,
- Ganesh Manoharan6 and
- Jane Moore7
- 1MonashHeart, Monash Health, Melbourne, Victoria, Australia
- 2St. George's Hospital, London, United Kingdom
- 3Waikato Hospital, Hamilton, New Zealand
- 4Leeds General Infirmary, Leeds, United Kingdom
- 5Epworth, Richmond, Victoria, Australia
- 6Royal Victoria Hospital, Belfast, United Kingdom
- 7Medtronic, Saint Paul, Minnesota, United States
The Evolut R CE Study evaluated the repositionable CoreValve Evolut R transcatheter aortic valve (TAV, Medtronic, Minneapolis, MN) in patients with symptomatic aortic stenosis and heart-team assessed risk of operative mortality. We plan to report the final 2-year outcomes at the meeting.
The Evolut R CE Study enrolled patients at 6 sites in Australia, New Zealand and the United Kingdom and included the first use of the valve for all operators. An independent echocardiographic core laboratory was employed, and Clinical Events Committee adjudicated major adverse events according to Valve Academic Research Consortium-2 criteria.
The study cohort comprised 60 patients; all successfully implanted with the Evolut R TAV. Mean age was 82.8± 6.1 years; 66.7% women, 68.3% with New York Heart Association (NYHA) III/IV symptoms, and mean STS PROM was 7.0%±3.7%. The majority of patients (68.3%) were considered frail. The repositioning feature of the Evolut R was successfully used 22 times in 15 patients. At 1 year, 4 patients had died (6.7%) and 2 patients had a disabling stroke (3.4%). A new pacemaker was required in 7 patients through 30 days (11.7%), with 2 additional implanted after 30 days for a 1-year rate of 15.2%. NYHA class improved from baseline to 1 year in 89.8% of patients. Forward flow hemodynamics continued to be excellent, with mean AV gradient of 7.5 ± 2.7 mmHg and mean EOA of 1.9 ± 0.4 cm2 at 1 year. In paired analysis, none or trace paravalvular leak (PVL) was present in 19/45 patients (42.2%) post-procedure; and 28/45 (62.2%) at 1 year. Two patients (4.3%) had moderate PVL and no patients had severe. No incidence of valve thrombosis, migration, embolization, coronary obstruction, endocarditis or evidence of structural valve degeneration has been reported through 1 year follow-up.
The Evolut R was associated with good safety and efficacy through 1 year. We plan to report final 2-year outcomes at the time of the meeting.
STRUCTURAL: Valvular Disease: Aortic