UK & Ireland Implanters' Registry Evaluates Initial Experience of Medtronic's Evolut R TAVR Device

November 6, 2018—The results of the initial experience of a large, self‐expanding, and fully recapturable transcatheter aortic valve replacement (TAVR) device in the United Kingdom and Ireland were published by Cameron Dowling, MD, et al in Catheterization and Cardiovascular Interventions. The UK & Ireland Implanters’ registry is a multicenter registry that reported on real‐world experience with the novel 34-mm Evolut R TAVR device (Medtronic), which is designed to treat patients with a large aortic annulus.

The investigators prospectively collected the clinical, procedural, and 30‐day outcome data from all patients that received the 34-mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland between January 2017 and April 2018.

The primary efficacy outcome was the endpoint of device success as defined by the Valve Academic Research Consortium‐2 (VARC‐2). The primary safety outcome was the VARC‐2–defined composite endpoint of early safety at 30 days.

As summarized in Catheterization and Cardiovascular Interventions, a total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients.

The investigators reported that device success was 79.7%. Mean gradient was 7.0 ± 4.6 mm Hg and effective orifice area 2.0 ± 0.6 cm². Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all‐cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%.

Real‐world experience of the 34-mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation, concluded the investigators in Catheterization and Cardiovascular Interventions.