Early Real-World Experience with CoreValve Evolut PRO and R Systems for Transcatheter Aortic Valve Replacement

Abstract

Objectives. The purpose of this study was to compare the efficacy and safety of the Evolut PRO to the Evolut R valve in a real-world setting. Background. The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. Methods. We retrospectively studied 134 patients who underwent TAVR with the Evolut PRO or Evolut R valve over one year at a tertiary center. Endpoints, defined by the Valve Academic Research Consortium-2 criteria, included device success, paravalvular leak (PVL), and a composite safety endpoint including mortality, stroke, major vascular complications, life-threatening bleeding, acute kidney injury, coronary artery obstruction, and repeat procedure for valve-related dysfunction. Results. 60 Evolut PRO and 56 Evolut R patients met the study criteria. Both groups had similar device success rates (90 vs. 89%, p=0.44). Incidence of moderate PVL was similar on discharge (5 vs. 11%, p=0.68) and at 30 days (11 vs. 13%, p=0.79), with nil incidence of severe PVL. There were no mortalities, and the VARC-2 safety endpoint at 30 days was comparable. Conclusion. Despite the additional pericardial skirt and larger sheath size of Evolut PRO, outcomes were comparable between the two Evolut systems, supporting adoption of the newest generation valve in the management of severe aortic stenosis as well as continued use of the Evolut R in patients with smaller vasculature warranting a lower profile device.

Intraventricular Conduction Disturbances After Transcatheter Aortic Valve Implantation

“…29 In that study, a potentially protective effect of PMI however, there were no differences in all-cause and cardiovascular mortalities between those with and without PMI. 21 In contrast, a negative clinical impact was reported in a cohort of 9,785 patients who underwent TAVI. 58 PMI was required in 6.7% after TAVI…”

“…2,4,[16][17][18][19] The incidence of new-onset LBBB appears to be more frequent for some self-expandable newer-generation devices, such as the Evolut R/ PRO (Medtronic; 44%) and Lotus (Boston Scientific; 74%). [20][21][22]…”

Update on Transcatheter Aortic Valve Replacement

“…These data have demonstrated that self-expanding valves are superior to balloon-expandable valves in terms of pacemaker rates and PVR for small annuli [29]. However, mortality outcomes have been equivocal, and these data are likely obsolete with newer designs aimed at reducing such complications [3,29,30] (Fig. 1 [23, 28, 31]).…”

“…The limited data available for the SAPIEN 3 Ultra show a moderate paravalvular regurgitation rate of 1.4%, with no cases of severe paravalvular regurgitation [36]. No outcome data are available at this time for the Evolut Pro?, but paravalvular regurgitation rates for its predecessor, the Evolut Pro, have been reported as low as 5% [30]. One-year follow-up data from the Lotus system showed no severe perivalvular regurgitation and only 0.4% of patients exhibiting moderate perivalvular regurgitation [37].…”

“…More data from the PARTNER 3 trial using the SAPIEN 3 system were published in May 2019 and revealed a 23.7% rate of left bundle branch block at 1 year [7]. Early data from the Evolut Pro have shown reduced incidence of left bundle branch block compared with the Evolut R device, but it remains relatively high at 38.8% [30]. This information helps define a range for which to expect left bundle branch block to develop, but these outcomes may not accurately reflect rates of the Evolut Pro?…”