Key result
The 34 mm Evolut-R transcatheter aortic prosthesis significantly improved VARC-2 early safety at discharge compared to the 31 mm CoreValve (0% vs. 27.9%, P=0.004).
Why the study?
Does the 34 mm Evolut-R prosthesis reduce periprocedural complications and improve short-term outcomes compared to the 31 mm CoreValve in patients undergoing TAVI?
Cohort (n=106)
Yes
Does the 34 mm Evolut-R prosthesis reduce periprocedural complications and improve short-term outcomes compared to the 31 mm CoreValve in patients undergoing TAVI?
The second-generation 34 mm Evolut-R transcatheter aortic valve demonstrates an improved short-term safety profile compared to its 31 mm CoreValve predecessor, including reduced rates of new pacemaker implantation and bleeding.
May support 34 mm Evolut-R selection for better early safety; leaves open need for randomized confirmation.
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.
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Kalogeras et al. (2018) conducted a cohort in Aortic valve disease requiring transcatheter aortic valve implantation (n=106). 34 mm Evolut-R transcatheter aortic prosthesis vs. 31 mm CoreValve prosthesis was evaluated on VARC-2 defined early safety (p=0.004). The 34 mm Evolut-R transcatheter aortic prosthesis significantly improved VARC-2 early safety at discharge compared to the 31 mm CoreValve (0% vs. 27.9%, P=0.004).
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