Real‐world comparison of the new 34 mm self‐expandable transcatheter aortic prosthesis Evolut R to its 31 mm core valve predecessor

Abstract

Objectives The aim of the present study was to compare the incidence of periprocedural complications and short‐term outcomes between the second‐generation recapturable 34 mm Evolut‐R and its first‐generation 31 mm predecessor. Background Although already in extensive clinical use in real world patients, the periprocedural complications and clinical outcomes of the new 34 mm device have not been investigated yet. Methods Consecutive patients who had undergone transcatheter aortic valve implantation in two centers with either a 31 mm CoreValve or a 34 mm Evolut‐R device were retrospectively studied. Periprocedural complications of malpositioning, valve‐in‐valve implantation, conversion to full sternotomy or percutaneous coronary intervention and vascular complications were compared between the two groups. Short‐term outcomes at discharge were compared using Valve Academic Research Consortium (VARC‐2) criteria. Results The study group included 106 patients (35 Evolut‐R 34 mm; 71 CoreValve 31 mm). Significantly lower rates of valve‐in‐valve implantation were demonstrated for the 34 mm group compared to the first‐generation device (0% vs. 11.9%, respectively, P = 0.036). All other periprocedural complications were similar between groups. At discharge, the rates of new pacemaker implantation (5.7% vs. 26.8%, P = 0.037) and bleeding complications (2.9% vs. 19.6%, P = 0.025) were statistically significantly lower among the 34 mm group. With regards to VARC‐2 defined combined endpoints, rates of early safety were significantly improved among the 34 mm group compared to 31 mm group (0% vs. 27.9%, respectively, P = 0.004). Conclusions The recently introduced 34 mm Evolut‐R seems to demonstrate an improved safety profile, as evidenced by the reduced bleeding rates, lower rates of valve‐in‐valve implantation and lower PPM rates compared to its 31 mm predecessor.

Early clinical and procedural outcomes in large series of 34‐mm self‐expanding transcatheter aortic valve replacement

“…Only one patient had a peak AV velocity > 3 m/s postprocedure. These success rates by VARC‐2 criteria are comparable to recently published results of similar prostheses …”

Comparison of Evolut-R 34 mm Valve and Smaller Evolut-R Valves in Patients Undergoing Transcatheter Aortic Valve Implantation and Determination of Mild Paravalvular Leak Predictors

“…The use of a smaller sheath and improved delivery capability (in-line sheath) on the Evolut-R 34 mm valve (16 Fr) compared to its predecessor 31 mm (18 Fr) reduced bleeding complication rates. 14 The 16-Fr equivalent EnVeo R delivery catheter system is of a larger size compared to the 14-Fr equivalent system utilized for the 23/26/29 mm Evolut R valves. Nonetheless, due to the larger iliofemoral vessels in this patient group, the incidence of bleeding and major vascular complications exhibited similar rates.…”

“… 6 - 10 However, compared to the previous 31 mm self-expanding prosthesis, pacemaker rates are much lower. 14 This is a crucial consideration to ensure the safe utilization of the larger valve without causing a substantial increase in the rate of PPM implantations.…”