One‐year clinical outcome with a novel self‐expanding transcatheter heart valve

Abstract

ObjectivesTo evaluate 1‐year outcome using the ACURATE neo (Symetis S.A., a Boston Scientific Company, Ecublens, Switzerland) according to the updated Valve Academic Research Consortium (VARC‐2) with emphasis on the composite endpoints “clinical efficacy after 30 days” and “time‐related valve safety”.BackgroundInitial reports on the clinical performance of patients treated with the ACURATE neo are promising; however, information regarding one‐year outcome is scarce, especially with regard to the composite endpoints proposed by the VARC‐2.MethodsOne hundred and fifty one consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with the ACURATE neo for severe aortic valve stenosis were enrolled. Data were prospectively collected and event rates during follow‐up were calculated as the Kaplan–Meier estimates.ResultsMean age was 81.1 ± 5.9 years and 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2–20.5]. Device success was achieved in 88.1% (133/151) and procedure related mortality was 0.7% (1/151). At one‐year, all‐cause mortality was 3.3% (5/151), while permanent pacemaker implantation occurred in 12.7% (19/151) of patients. The “clinical efficacy after 30 days” was observed in 24.8% (37/151), where the main contributor was symptom worsening in 14.8% (22/151) of cases. “Time‐related valve safety” occurred in 22.0% (33/151) with structural valve deterioration as main contributor in 10.7% (16/151) of cases.ConclusionsUsing the ACURATE neo, we found a favorable safety profile with low all‐cause mortality at 1 year. The reported VARC‐2 defined composite endpoints at 1 year reveal low rates of “clinical efficacy after 30 days” and “time‐related valve safety”.

ACURATE neo: How Is This TAVR Valve Doing to Fit into an Increasingly Crowded Field?

“…The lower radial force may lead to less mechanical injury to the conduction system (Fig. 1 ) and explain the relatively low need for a new permanent pacemaker ranging from 8.3 to 12.3% [ 10 – 12 , 13 •, 15 , 16 , 17 •], which is considerably lower than reported pacemaker rates of other self-expanding THVs (17.4 to 34.1%) [ 3 , 21 ]. Evidence from a small multicenter study suggested that the rate of new permanent pacemakers can be reduced to 2.3% when applying a minimizing trauma strategy using a smaller balloon for pre- and post-dilation [ 12 ].…”

“…Several studies have investigated the clinical outcomes up to 1 year after implantation of the ACURATE neo THV for treatment of severe aortic stenosis in elderly patients (Table 1 ) [ 10 – 12 , 13 •, 14 •, 15 , 16 , 17 •, 18 •, 19 , 20 ]. These studies have proposed some strengths and drawbacks of ACURATE neo, which may guide how to optimally tailor the device to the most appropriate anatomy.…”

“…In a randomized trial among 739 patients from 20 centers, the occurrence of valve-related dysfunction, mainly moderate or severe aortic regurgitation, at 30 days, was significantly higher among patients treated with ACURATE neo (9%) compared to Edwards SAPIEN 3 (3%) ( P < 0.0001) [ 5 ••]. In contrast, site-reported incidence of relevant paravalvular regurgitation (moderate to severe) in observational studies was considerably lower, ranging from 1.4 to 4.8% [ 10 – 12 , 13 •, 14 •, 15 , 16 ]. The supra-annular design of the THV achieves a larger effective orifice area (EOA) with lower transprosthetic gradients, and potentially prevents prosthesis-patient mismatch (Fig.…”

“…1 ) [ 22 ]. Across the studies, EOA and mean transprosthetic gradients ranged from 1.6 to 2.0 cm 2 and from 6.9 to 10.6 mmHg (mean or median), respectively [ 10 – 12 , 13 •, 14 •, 15 , 16 , 17 •]. In a propensity-score-matched comparison in patients with a small aortic annulus (area < 400 mm 2 ), the ACURATE neo THV was associated with a significantly lower incidence of prosthesis-patient mismatch as compared with the SAPIEN 3 THV [ 23 ].…”

A novel self‐expanding transcatheter heart valve: Shaping the story beyond accuracy

“…In this issue of the journal, Pellergrini and colleagues publish their single center VARC‐2 defined 1 year outcomes with a novel self‐expanding THV, the ACURATE neo (Symetis/Boston Scientific, Ecublens, Switzerland) in a population of intermediate risk patients (median logistic Euroscore I = 13.8). The ACURATE neo is a second generation Nitinol self‐expanding, supra annular porcine pericardial tissue THV.…”