Methods

Between January 2012 and June 2015 consecutive patients with severe symptomatic AS, examined by the Heart Team and deemed appropriate for TAVI, were included in the analysis. All procedures were performed by experienced teams in three tertiary hospitals with active on-site cardiothoracic department. Patients with true bicuspid aortic valve as detected by multislice computed tomography (MSCT) and previous aortic valve replacement (surgical or TAVI) were excluded from the study. Patients with a follow-up period ≥5 years after TAVI were analyzed. Primary events were prospectively recorded over the study period. The last available echocardiographic evaluation was considered for the analysis. The study conforms to the principles outlined in the Declaration of Helsinki and each hospital’s ethics committee approved the study. All patients provided informed consent regarding the procedure as well as storage and process of their personal medical data.

Transthoracic echocardiography was performed in all patients as part of the screening process. Severe AS was defined as an effective orifice area (EOA) <1 cm ² or EOAi (EOA indexed to the body surface area) <0.6 cm ² /m ² by the continuity equation and mean gradient >40 mm Hg or maximal aortic valve velocity >4.0 m/s on resting echocardiography (or after dobutamine infusion if the subject had a left ventricular ejection ventricular fraction <50%). All patients had an echocardiogram prior to discharge, at 1 month and yearly thereafter. Post-procedural echocardiographic data relate to the last available echocardiographic scan, performed either at the study hospitals or from referring physicians. Qualitative grading of aortic regurgitation (AR) severity (none, mild, moderate, severe) was based on integrating the available valve academic research consortium criteria-II (VARC-II). ^, The MSCT examination protocol used has already been described. ^, A commercially available and dedicated post processing software was used for all measurements (3mensio, Pie Medical Imaging, The Netherlands).

The TAVI procedure has been described previously. All procedures were performed in the catheterization laboratory, with stand-by echocardiography. The participating institutions opt for the minimal TAVI approach, aiming for local anesthesia and mild sedation whenever possible. All patients received 100 mg acetylsalicylic acid pre TAVI and lifelong thereafter and clopidogrel (300 mg as a bolus and 75 mg per day thereafter for 6 months, unless chronic use was deemed more appropriate). If chronic anticoagulation was in order, then dual therapy with clopidogrel and an oral anticoagulant was prescribed for 3 months and afterwards only the anticoagulant was preferred.

The TAVI prostheses used were the CoreValve/Evolut-R family (Medtronic Inc., Dublin, Ireland) with four available sizes at that time (23 mm, 26 mm, 29 mm, and 31 mm). The vascular access and size of the bioprosthesis was based at the operators’ discretion and on the available MSCT data.

All definitions, measured outcomes and endpoints were designated according to the Valve Academic Research Consortium criteria – second update (VARC-II) and the recently published consensus statement by the ESC/EAPCI for structural valve deterioration (SVD) and bioprosthetic valve failure (BVF). In detail and based on echocardiographic data, moderate SVD was defined as mean transprosthetic gradient ≥20 mm Hg and <40 mm Hg, and/or ≥10 mm Hg and <20 mm Hg change from baseline, and/or moderate new or worsening intraprosthetic AR, as assessed by imaging modalities. Severe SVD was defined as mean gradient ≥40 mm Hg, and/or ≥20 mm Hg change from baseline, and/or severe intraprosthetic AR. BVF was defined as severe SVD accompanied by the consequent clinical manifestations. Pathophysiological processes, such as thrombosis, endocarditis or nonstructural valve dysfunction resulting in symptomatic valve failure were also included under this term. Moreover, depending on timing of onset after valve implantation, BVF was considered early (<30 days) or late (>30 days). In addition, BVF included autopsy findings of bioprosthetic valve dysfunction, likely related to the cause of death, or valve-related death. Primary end points were all-cause and cardiovascular mortality, SVD and BVF rates. Secondary endpoints were echocardiographic changes of mean gradient (MG), paravalvular leakage (PVL) and overall changes in New York Heart Association (NYHA) functional status.

This is a prospective observational research. Continuous variables are presented as mean values ± one standard deviation and compared with the Student’s t test. The normality of distribution was assessed using the Shapiro-Wilk test and normality diagrams. Categorical variables are presented as frequencies and percentages and were tested by the chi-square test. Paired analysis was used for calculating echocardiographic differences in mean gradient changes. Differences in paired samples were tested using Wilcoxon signed-rank test or paired Student’s t test. All-cause mortality was reported by the use of Kaplan-Meier estimates and the respective confidence intervals. Multivariate regression analysis was performed to detect predictors of SVD. pvalues <0.05 were considered statistically significant. These analyses were performed with SPSS 25 statistical software (SPSS Inc., Armonk, NY). Cumulative incidence function was used for calculating the risk for SVD and BVF, competing for death risk analysis (these calculations were done by XLSTAT, Addinsoft, Paris, France).

Results

A total number of 273 high-risk patients ( Figure 1 ) underwent TAVI in three tertiary centers between January 2012 to June 2015 (center 1: 121 patients; center 2: 110 patients; center 3: 42 patients). Baseline clinical and echocardiographic parameters are presented in Tables 1 and 2 . No significant clinical or echocardiographic baseline differences were observed in patients presenting with SVD/BVF compared with the population with no SVD/BVF. Clinical follow-up was achieved in all the patients, with a median duration of 5 years (interquartile range: 2.9 to 6) and with the longest clinical follow-up being 8 years.

Flowchart of the study.

All the TAVI procedural data and clinical events are shown in Tables 3 and 4 respectively. The first generation CoreValve was implanted in 156 patients (57%) and the second generation Evolut-R was implanted in the remaining 117 patients (43%). Transfemoral access was the preferred route in 84% of the patients.

Table 3

Procedural characteristics (n = 273 patients)

Type of valve
• CoreValve • Evolut R	156 (57%) 117 (43%)
Access site
• Transfemoral • Subclavian • Transaortic	229 (84%) 42 (15%) 2 (1%)
Surgical cut-down	72 (26%)
Bioprosthesis size
• 23 mm • 26 mm • 29 mm • 31 mm	19 (7%) 98 (36%) 128 (47%) 28 (10%)
Type of anesthesia
• Local • General	215 (79%) 58 (21%)
Predilation	65 (24%)
Postdilation	40 (15%)
Procedure time, (min)	131.72 ± 43.26
Fluoroscopy time, (min)	28.53 ± 10.01
Contrast use, (mL)	156.66 ± 61.79
Valve-in-valve	13 (5%)

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