Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis (AS). Comparative data on the efficacy and safety of newer transcatheter heart valve (THV) devices is still evolving. We aim to compare clinical and hemodynamic outcomes of the Symetis ACURATE Neo-2® versus the Medtronic Evolut Pro/Pro +® and the Edwards Sapien-3® THVs, from a large cohort of patients undergoing TAVR. In this all-comer, single center trial, patients with severe symptomatic AS undergoing TAVR and treated with either ACURATE Neo-2 ( N = 240), Evolut Pro/Pro+ ( N = 324) or Sapien-3 ( N = 485) THVs were included. Baseline clinical, demographic and follow-up data were collected. Patients ( N = 1049) (female 48.6%) mean age 80.1 ± 7.7 years. ACURATE Neo-2 patients were predominantly female (81%) in comparison to Evolut Pro/Pro+ (59%) and Sapien-3 (26%). Need for post-TAVR permanent pacemaker implantation (PPI) was lower in the ACURATE Neo-2 group in comparison to the Evolut Pro/Pro+ and similar to the Sapien-3 group. Rates of ≥ moderate paravalvular leak (PVL) were similar between ACURATE Neo-2 and Evolut Pro/Pro+, but higher in comparison to Sapien-3. In sight of our center’s clinical approach to choosing various THV’s according to patient characteristics, The ACURATE Neo-2 constitutes a reliable and suitable tool for the treatment of patients with severe symptomatic AS undergoing TAVR. Even in the wake of the ACURATE Neo-2′s withdrawal, our study offers valuable contributions to ongoing discourse in the field of TAVR, emphasizing the necessity for continuous research and innovation to improve patient care and device efficacy.
Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with severe symptomatic aortic stenosis (AS) across the surgical risk spectrum. Large randomized trials and meta-analyses have demonstrated noninferiority or superiority of TAVR compared with surgical aortic valve replacement (SAVR), with favorable outcomes in low-risk patients and comparable mortality in high-risk cohorts. , The first-generation Symetis ACURATE Neo® (Boston Scientific, MA, USA) was evaluated in the SCOPE 1 and 2 trials, where it failed to meet noninferiority versus the Sapien 3® (Edwards Lifesciences, CA, USA) and CoreValve Evolut R® (Medtronic, MN, USA). SCOPE 2 trial showed lower rates of permanent pacemaker implantation (PPI) compared to the Evolut R. , The second-generation ACURATE Neo-2 is a self-expandable, supra-annular porcine valve with an enhanced sealing skirt to reduce paravalvular leak available in 3 sizes and suitable for annuli between 21 and 27 mm ( Figure 1 ). The randomized ACURATE IDE trial recently failed to show noninferiority versus Evolut and Sapien platforms. Despite its market withdrawal, real-world comparative data remain valuable. Our study compares the performance of the ACURATE Neo-2 with Evolut Pro/Pro+ and Sapien 3 in an all-comers TAVR population, aiming to improve future practice and device evaluation.
Main characteristics of the ACURATE Neo-2 THV. Characteristics of the Acurrate Neo-2 THV device.
Methods
We performed an observational cohort study that included patients that underwent TAVR at the Rabin Medical Centre in Petach Tikva, Israel between 2015 and 2023. Our TAVR registry collects prospective data for all consecutive TAVR procedures performed in this public, academic, tertiary center. For this analysis, only patients undergoing denovo TAVR for severe aortic stenosis were included. The selection and assessment process of these patients in our institution has previously been described. Briefly, patients with severe symptomatic aortic stenosis (AS) were assessed by a multidisciplinary “heart team” at our institution. Severe AS was defined as a valvular orifice area <1.0 cm² or <0.6 cm²/m² and/or a mean pressure gradient >40 mm Hg and/or jet velocity ≥4.0 m/s. Candidates underwent comprehensive evaluations, including transthoracic echocardiography, coronary angiography when indicated, transesophageal echocardiography when needed, and gated cardiac CT angiography, to determine valve sizing, calcium burden, and vascular access. Treatment decisions considered operative risk, including age, comorbidities, and frailty, assessed by gait speed, daily living activities, albumin levels, oxygen dependency, cognitive status, and clinician evaluation. Anatomic factors such as iliac-femoral artery diameter and access route suitability were also evaluated. The choice of THV was based on comprehensive evaluation of patient-specific and technical-explicit data and was left to the operators’ choice.
Our primary endpoints were: All-cause mortality up to 4-year follow up, periprocedural rates of need for permanent pacemaker implantation (PPI), rates of vascular complications, periprocedural Stroke & TIA and paravalvular leak (PVL). Endpoints were defined according to VARC-3 Criteria.
Follow up data regarding valve hemodynamics was based on review of follow up echocardiograms performed in our institution as well as in community-based cardiology clinics.
Demographic data, including patient age, gender, and mortality dates, were sourced from the medical center’s demographic information system, linked to the State of Israel Ministry of Interior database for mortality data adjudication.
All data were recorded into the institutional review board (IRB) approved RECORD TAVR Database, which included procedural details, clinical characteristics, echocardiographic findings, laboratory results, demographic data, valve performance metrics and mortality dates. The prospective data collection was approved by the IRB.
Statistical analysis
Statistical analyses were performed using Genie Statistics ( www.geniestat.com ) and IBM SPSS, version 25.0 (SPSS, Chicago, IL, USA).
Primary analysis
We compared the 3 groups (ACURATE Neo-2, Evolut Pro/Pro+, and Sapien-3) concerning demographic characteristics (age, gender, weight, height), comorbidities (diabetes, hypertension, peripheral vascular disease, COPD), renal function (GFR), hematologic parameters (hematocrit), procedural risk scores (STS score), baseline ECG findings (LBBB, RBBB, prior pacemaker), and annular measurements (perimeter and area) obtained from cardiac CT angiography. Also, we compared the ACURATE Neo-2 group with Evolut Pro/Pro+ and the Sapien-3 groups, concerning the different outcomes, including new RBBB and LBBB, the need for new pacemaker implantation (both in-hospital and up to 1 year), vascular complication rates, in-hospital stroke incidence, postprocedural hospital stay duration, and paravalvular leak severity at 1 month and 1 year. Normally distributed continuous variables were compared using the student’s t-test while non-normally distributed variables were compared using the Mann Whitney U test. Categorical variables were compared using the chi-square and/or Fisher’s exact test, as appropriate. All tests were 2-tailed, and a p-value <0.05 was considered significant.
Also, both univariate and multivariate cox-regression models were performed to compare all-cause mortality rate up to 4-year follow up between the 3 groups. The ACURATE Neo-2 group was defined as the reference group, Hazard Ratios with 95% confidence intervals (CI) were calculated for both the Evolut Pro and the Sapien-3 groups compared with the ACURATE Neo-2 group. Proportionality assumption was assessed using the Schoenfeld Residuals Method.
Sensitivity analysis
For a sensitivity analysis we performed a propensity score matched paired analysis of patients receiving the ACURATE-Neo 2 vs patients with the compared valve. The analysis was performed separately for each comparison. A propensity score was calculated using logistic regression with complete preprocedural variables, without imputation, and choice of valve as the independent variable. Propensity score matching was performed using a closest neighbor, greedy algorithm, attempting to match each ACURATE-Neo2 patient with a comparator-valve patient with the closest propensity score, with a maximal difference of less than 0.25 times the standard deviation of the scores. Each pair was used once, and unpaired cases were not used in further analysis.
Results
In this cohort of patients ( N = 1049), 48.6% were female, mean age was 80.03 ± 7.7 years. Patients were divided into 3 groups according to THV used: Symetis ACURATE Neo-2 (22.9%), Medtronic-Evolut Pro/Pro+ (30.9%) and Edwards Sapien-3 (46.2%). Within each THV group, patients were implanted with either small, medium or large valves with a different percentage of oversizing ( Supplementary Figures 1 and 2 ). Patients in the ACURATE Neo-2 group were predominantly female with lower body mass index (BMI) and smaller aortic annulus per gated cardiac computed tomography (CT) (valve perimeter was 71.5 ± 5mm vs 73.9 ± 6.4mm vs 80.4 ± 7.1mm for the ACURATE Neo-2, the Evolut Pro/+ and the Sapien-3 group; respectively, p <0.0001). Valve area was 388.5 ± 52.0 versus 425.1 ± 88.2 versus 500.8 ± 91.3 for the ACURATE Neo-2, the Evolut Pro/Pro+ and the Sapien-3 groups: respectively, p <0.0001 ( Table 1 ).
Table 1
Baseline characteristics
|
ACURATE Neo 2
n = 240 |
Evolut Pro
n = 324 |
Sapien 3
n = 485 |
p-value | |
|---|---|---|---|---|
| Age median (IQR) | 82.0 (9.0) | 82.0 (8.0) | 79.0 (10.0) | <0.0001 |
| Male gender | 19% | 41% | 74% | <0.0001 |
| Weight (mean +/- SD) | 72.6 +/−16.6 | 75.1 +/−16.3 | 80.3 +/−15.5 | <0.0001 |
| Height | 157.7 +/−12.4 | 162.3 +/−8.3 | 168.0 +/−10.1 | <0.0001 |
| Diabetes | 39% | 48% | 45% | 0.104 |
| Hypertension | 72% | 86% | 80% | <0.0001 |
| Peripheral vascular disease | 3% | 4% | 8% | 0.009 |
| COPD | 6% | 10% | 13% | 0.029 |
| GFR | 61.9 +/−22.9 | 60.9 +/−23.0 | 66.4 +/−25.2 | 0.016 |
| Hematocrit | 37.9 +/−4.8 | 37.5 +/−4.4 | 38.5 +/−4.9 | 0.112 |
| STS score median (IQR) | 2.855 (2.822) | 2.77 (1.906) | 2.0 (1.8) | <0.0001 |
| LBBB on baseline ECG | 9% | 10% | 13% | 0.237 |
| RBBB on baseline ECG | 8% | 8% | 11% | 0.313 |
| Prior Pacemaker | 10% | 49% | 24% | <0.0001 |
| Aortic annulus perimeter (on Cardiac CTA) | 71.5 +/−5.0 | 73.9 +/−6.4 | 80.4 +/−7.1 | <0.0001 |
| Aortic annulus area | 388.5 +/−52.0 | 425.1 +/−88.2 | 500.8 +/−91.3 | <0.0001 |
COPD = chronic obstructive pulmonary disease; CTA = coronary computed tomography angiography; ECG = electrocardiogram; GFR = glomerular filtration rate; IQR = interquartile range; LBBB = left bundle branch block; RBBB = right bundle branch block; SD = standard deviation; STS = Society of Thoracic Surgeons.
All-cause mortality rates at 4-year follow up, in both univariate and multivariate cox regression, adjusted for STS score, were similar irrespective of THV device used (Univariate: Evolut pro vs ACURATE Neo-2; RR = 1.34 95% CI 0.25 to 7.22, Sapien-3 vs ACURATE Neo-2 RR = 0.69 95% CI 0.12 to 3.99. Multivariate: Evolut pro vs ACURATE-Neo 2; RR= 1.31 95% CI 0.24 to 7.07, Sapien 3 vs ACURATE-neo 2 RR = 0.76 95% CI 0.13 to 4.41) ( Figure 2 ).
All-cause mortality. Rates of All-cause mortality—adjusted for STS score, stratified by THV device. STS = Society of Thoracic Surgeons.
Univariate comparative outcomes of the ACURATE Neo-2 versus the Evolut Pro/Pro+ and the Sapien-3 are shown in Tables 2 and 3 , respectively. Rates of PPI were lower in the ACURATE Neo-2 group in comparison to the Evolut Pro/Pro+ (8% vs 17%, p = 0.01; respectively) and similar in comparison to the Edwards Sapien-3 group (8% vs 11% p = 0.25; respectively). Rates of minor and major vascular complications showed no significant difference between the ACURATE Neo-2 group in comparison to either the Evolut Pro/Pro+ (6.7% and 1.7% vs 9.9% and 3.7%, p = 0.128; respectively), or the Sapien-3 groups (6.7% and 1.7% vs 7.6 and 1.6%, p = 0.826; respectively). Rates of periprocedural stroke & transient ischemic attack (TIA) were similar amongst the groups (ACURATE Neo2 1.2% Evolut Pro/Pro+ 3.1% Sapien3 1.2% p = 0.170 and p = 1.0 for pairwise comparisons), with all events being minor. Patients treated with the ACURATE Neo-2 THV device had a shorter length of hospitalization in comparison to the Evolut-pro/Pro + group of patients (5% trimmed mean −3.1 days vs 3.66 days p <0.0001; respectively) and comparable to the Sapien-3 group (5% trimmed mean −3.1 days vs 3.22 days p = 0.399; respectively).
Table 2
Outcomes- ACURATE Neo2 versus Evolut pro
|
ACURATE Neo 2
n = 240 |
Evolut Pro
n = 324 |
p-value | |
|---|---|---|---|
| New RBBB | 4% | 4% | 1.000 |
| New LBBB | 16% | 22% | 0.068 |
| In-hospital new pacemaker * | 8% | 17% | 0.010 |
| IH up to 1 year new pacemaker | 11% | 18% | 0.074 |
| Vascular complication rate- minor | 6.7% | 9.9% | 0.128 |
| Vascular complication rate-major | 1.7% | 3.7% | 0.128 |
| In-hospital stroke | 1.2% | 3.1% | 0.170 |
| Post procedural hospital stay (days) † | 3.1 | 3.66 | <0.0001 |
| 1-month paravalvular leak | |||
| None or trivial | 48% | 43% | 0.568 |
| Mild | 48% | 54% | |
| ≥Moderate | 3% | 3% | |
| 1-year paravalvular leak | |||
| None or trivial | 57% | 56% | 0.563 |
| Mild | 40% | 37% | |
| ≥Moderate | 4% | 7% |
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