The SAPIEN 3 valve (S3V) is a new-generation transcatheter valve with enhanced anti-paravalvular leak properties, but no data comparing with earlier transcatheter valve systems are available. We aimed to compare the hemodynamic performance of the S3V and the SAPIEN XT valve (SXTV) in a case-matched study with echo core laboratory analysis. A total of 27 patients who underwent transcatheter aortic valve replacement (TAVR) with the S3V were matched for prosthesis size (26 mm), aortic annulus area, and mean diameter measured by computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 50 patients treated with the SXTV. The prosthesis size was determined by oversizing of 1% to 15% of annulus area. Doppler echocardiographic images collected at baseline and 1-month follow-up were analyzed in a central echocardiography core laboratory. The need for postdilation was higher in the SXTV group (20% vs 4%, p = 0.047), and mean residual gradient and effective orifice area were similar in both groups (p >0.05). The incidence of paravalvular aortic regurgitation was greater with the SXTV (≥mild: 42%, moderate: 8%) than with the S3V (≥mild: 7%, moderate: 0%; p = 0.002 for ≥mild vs SXTV). The implantation of an S3V was the only factor associated with trace or no paravalvular leak after TAVR (p = 0.007). In conclusion, TAVR with the S3V was associated with a very low rate of paravalvular leaks and need for balloon postdilation, much lower than that observed with the earlier generation of balloon-expandable valve (SXTV). The confirmation of these results in a larger cohort of patients will represent a major step forward in using transcatheter valves for the treatment of aortic stenosis.
Highlights
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Despite major improvements in aortic annulus measurements and valve sizing, the occurrence of paravalvular leaks remains one of the most important challenges of transcatheter aortic valve implantation (TAVI).
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The present case-matched study with central echo core laboratory analysis showed a major reduction in the occurrence and severity of residual aortic regurgitation after TAVI with a new-generation balloon-expandable valve with enhanced anti-paravalvular leak properties (SAPIEN 3) compared with an earlier generation transcatheter valve (SAPIEN XT). Also, the SAPIEN 3 valve was associated with a significant reduction in the need for balloon postdilation after TAVI.
The balloon-expandable SAPIEN 3 valve (S3V; Edwards Lifesciences Inc., Irvine, California) is a new-generation transcatheter valve that incorporates an external sealing cuff at the bottom of the stent frame to reduce the incidence of paravalvular leaks. The preliminary results of a first-in-man series including 15 patients who underwent transcatheter aortic valve replacement (TAVR) showed the feasibility and safety of this new system. Also, the rate of paravalvular leaks ≥mild was <30%, with no cases of moderate aortic regurgitation (AR) after TAVR. These data, however, were not evaluated in a central echo core laboratory, and it is well known that determining the presence and severity of AR after TAVR can be associated with high variability. Moreover, no data exist on the comparison of the hemodynamic performance of this new-generation transcatheter valve with earlier generation valve systems. The objective of this study was, therefore, to compare the hemodynamic performance of the S3V valve with the balloon-expandable SAPIEN XT valve (SXTV) as evaluated in a central echocardiography laboratory, with special focus on the presence and degree of paravalvular leaks.
Methods
A total of 27 consecutive patients with severe symptomatic aortic stenosis underwent TAVI with the SAPIEN 3 device (Edward Lifesciences) in 2 centers. These patients were matched with patients who had undergone transcatheter aortic valve implantation (TAVI) with the 26-mm SXTV who were drawn from a prospective database of 270 consecutive patients who survived the periprocedural period. The matching criteria (all pre-TAVI) were (1) prosthesis size (26 mm, exact match), (2) aortic annulus area (within 50 mm 2 ) as assessed by multidetector computed tomography (MDCT), (3) mean aortic annulus diameter as assessed by MDCT (within 0.5 mm), (4) left ventricular ejection fraction (within 10%) measured by transthoracic echocardiography, (5) body surface area (within 0.4 m 2 ), and (6) body mass index (within 5 kg/m 2 ). A variable number of controls (from 1 up to 4) was used leading to a final sample of 50 matched patients who had undergone TAVI with the SXTV. The values of the matched variables, according to valve type, are listed in Table 1 .
| Variable | All (n = 77) | Sapien XT (n = 50) | Sapien 3 (n = 27) | p-Value |
|---|---|---|---|---|
| Mean aortic annulus diameter ∗ (mm) | 24.5 ± 1.6 | 24.6 ± 1.7 | 24.2 ± 1.3 | 0.391 |
| Aortic annulus area ∗ (mm 2 ) | 467 ± 45 | 465 ± 48 | 472 ± 37 | 0.615 |
| Left ventricular ejection fraction (%) | 52 ± 12 | 53 ± 14 | 51 ± 9 | 0.293 |
| Body surface area (m 2 ) | 1.92 ± 0.21 | 1.90 ± 0.22 | 1.96 ± 0.20 | 0.243 |
| Body mass index (kg/m 2 ) | 27 ± 6.2 | 27.4 ± 5.7 | 26.3 ± 7.1 | 0.480 |
MDCT examinations were performed and interpreted according to the criteria recommended by Achenbach et al. Briefly, MDCT acquisition protocol was performed ECG gated (in systole), during suspended respiration, with a system of 64 simultaneously acquired slices and administration of iodinated contrast medium. Reconstruction of 0.6-mm slice width throughout the entire imaging volume was obtained.
Prosthesis sizing was determined on the basis of aortic annulus area measurements as previously described. The objective was to obtain a 1% to 15% prosthesis area oversizing with respect to the aortic annulus area in all patients. The TAVR procedure has been explained in detail in previous publications. The procedures were guided by fluoroscopy/angiography and transesophageal echocardiography. Procedural data and 30-day events were prospectively recorded and defined according to the Valve Academic Research Consortium-2 criteria. The procedures were performed under a compassionate clinical use program approved by Health Canada, and all patients provided signed informed consent.
All patients underwent a complete transthoracic echocardiographic examination, according to the guidelines of the American Society of Echocardiography, before the procedure and at 1-month follow-up (available for all patients). All echocardiographic examinations were evaluated in the echocardiography core laboratory of the Quebec Heart and Lung Institute (directed by PP and JGD). All images were stored in digital format, and the analyses were performed off-line by experienced technicians and supervised by a cardiologist (JGD) unaware of the clinical data and prosthesis type (structural differences between the 2 valve types cannot be distinguished by echocardiography) using an Image Arena Platform (TomTec Imaging Systems, Unterschleissheim, Germany). Valve types were not distinguishable in echocardiographic images. The following measurements were obtained for all patients: aortic annulus diameter, left ventricular outflow tract diameter, stroke volume, left ventricular ejection fraction evaluated using the biplane Simpson method, the mean and peak transvalvular gradient estimated with the modified Bernoulli formula, and valve effective orifice area (EOA) calculated using the continuity equation. The aortic annulus was measured in a zoomed parasternal long-axis view from the hinge point of the anterior aortic cusp and the ventricular septum to the junction of the posterior aortic cusp and the anterior mitral leaflet. After TAVR, the left ventricular outflow tract diameter was measured just underneath the apical margin of the prosthesis stent. The left ventricular outflow tract Doppler recordings were also obtained just below the stent margin to ensure that the flow velocities were recorded at the same location as the left ventricular outflow tract diameter. If the transcatheter valve was positioned low in the left ventricular outflow tract with the stent margin close to the apical end of the left ventricular outflow tract, the measures of the left ventricular outflow tract diameter and velocity were obtained within the stent just below the transcatheter valve leaflets. The Doppler velocity index was calculated as the left ventricular outflow tract velocity/transvalvular velocity ratio.
The presence, degree, and type (paravalvular vs transvalvular) of AR were recorded for all patients. The AR severity was evaluated using a multiparametric approach and classified following the VARC-2 recommendations. The severity of AR was classified as follows: none-trace, mild, moderate, and severe. In the presence of paravalvular AR, the number of jets, localization, and the circumferential extent were also assessed. The circumferential extent of the paravalvular jets was measured in the parasternal short-axis views with color Doppler.
Each matched group was considered as a stratification variable. Categorical variables were expressed in percent and analyzed using the generalized Cochran-Mantel-Haenszel test to detect association between valve type and categorical variables observed in strata. Continuous variables were reported using mean ± SD and analyzed using a 2-way analysis of variance with 1 random factor associated with the stratification. All hypothesis testing were 2 sided with a significance level of 0.05. Data were analyzed with the statistical packages R, v3.0.2 (R Foundation for Statistical Computing, Vienna, Austria) and SAS, v9.4 (SAS Institute Inc, Cary, NC).
Results
There were no differences in baseline clinical characteristics between groups ( Table 2 ). The main echocardiography and MDCT characteristics according to valve type are listed in Table 3 . There were no differences between groups in the severity of aortic stenosis (p >0.50 for mean transvalvular gradient and EOA), and the diameter of aortic annulus as evaluated by transesophageal echocardiography was also similar between the 2 groups (S3V: 23.1 ± 2.7 mm, SXTV: 22.8 ± 2.3 mm, p = 0.550). Apart from the matched MDCT variables (aortic annulus area and mean diameter), the 2 groups were also well balanced regarding the aortic annulus eccentricity index (p = 0.867) and the degree of aortic valve calcification (p = 0.526). Also, the degree of valve oversizing was similar (p = 0.297) in the S3V (10.5 ± 7.5%) and SXTV (13.2 ± 10.2%) groups.
| Variable | All (n = 77) | Sapien XT (n = 50) | Sapien 3 (n = 27) | p Value |
|---|---|---|---|---|
| Age (years) | 81 ± 6 | 80 ± 7 | 83 ± 6 | 0.881 |
| Women | 51 (66%) | 30 (60%) | 21 (78%) | 0.117 |
| Body surface area (m 2 ) | 1.92 ± 0.21 | 1.90 ± 0.22 | 1.96 ± 0.20 | 0.243 |
| NYHA class III–IV/IV | 56 (73%) | 38 (76%) | 18 (67%) | 0.434 |
| Body mass index (Kg/m 2 ) | 27 ± 6.2 | 27 ± 5.7 | 26 ± 7.1 | 0.652 |
| Hypertension ∗ | 67 (87%) | 44 (88%) | 23 (85%) | 0.694 |
| Dyslipidemia ∗ | 63 (82%) | 38 (76%) | 25 (93%) | 0.180 |
| Diabetes mellitus | 20 (26%) | 12 (24%) | 8 (30%) | 0.792 |
| Chronic atrial fibrillation | 17 (22%) | 11 (22%) | 6 (22%) | 1.000 |
| Coronary artery disease | 56 (72%) | 33 (66%) | 23 (85%) | 0.062 |
| Prior coronary by-pass | 22 (29%) | 17 (34%) | 5 (18%) | 0.317 |
| Cerebrovascular disease | 12 (16%) | 7 (14%) | 5 (18%) | 0.710 |
| Chronic obstructive pulm. disease | 23 (30%) | 13 (26%) | 10 (37%) | 0.770 |
| Estimated glomerular filt. rate (mL/min) | 65 ± 25 | 67 ± 27 | 62 ± 22 | 0.313 |
| Logistic EuroSCORE (%) | 19.7 ± 10.8 | 18.4 ± 10.8 | 21.9 ± 10.6 | 0.136 |
| Society of thoracic surgeons score (%) | 6.3 ± 3.3 | 5.9 ± 3.5 | 7.1 ± 2.8 | 0.136 |
∗ Hypertension: blood pressure greater than 140/90 on two or more blood pressure readings taken at each of two or more visits after initial screening. Dyslipidemia: total cholesterol concentration of 240 mg/dl or higher.
| Variable | All (n = 77) | Sapien XT (n = 50) | Sapien 3 (n = 27) | p-Value |
|---|---|---|---|---|
| Echocardiography | ||||
| Aortic annulus diameter (mm) ∗ | 22.8 ± 2.3 | 22.8 ± 2.3 | 23.1 ± 2.7 | 0.550 |
| Left ventricular ejection fraction (%) | 52 ± 12 | 53 ± 14 | 51 ± 9 | 0.531 |
| Heart rate (beats/min) | 70 ± 15 | 70 ± 15 | 67 ± 7 | 0.687 |
| Stroke volume (mL) | 76 ± 110 | 77 ± 116 | 61 ± 18 | 0.785 |
| Peak aortic gradient (mm Hg) | 67 ± 25 | 67 ± 26 | 68 ± 23 | 0.918 |
| Mean aortic gradient (mm Hg) | 38 ± 16 | 38 ± 17 | 36 ± 12 | 0.728 |
| Effective orifice area (cm 2 ) | 0.64 ± 0.21 | 0.65 ± 0.23 | 0.63 ± 0.16 | 0.954 |
| Doppler velocity index | 0.19 ± 0.10 | 0.20 ± 0.11 | 0.16 ± 0.04 | 0.662 |
| Systolic pressure of pulmonary artery (mm Hg) | 41 ± 16 | 41 ± 16 | 42 ± 16 | 0.869 |
| Aortic regurgitation grade | 0.887 | |||
| None or trivial | 44 (57%) | 29 (62%) | 15 (55%) | |
| Mild | 26 (34%) | 15 (32%) | 11 (41%) | |
| Moderate | 3 (4%) | 2 (4%) | 1 (4%) | |
| Severe | 1 (1%) | 1 (2%) | 0 | |
| Mitral regurgitation grade | 0.186 | |||
| None or trivial | 20 (26%) | 15 (30%) | 5 (18%) | |
| Mild | 39 (51%) | 25 (50%) | 14 (52%) | |
| Moderate | 17 (22%) | 10 (20%) | 7 (26%) | |
| Severe | 1 (1%) | 0 (0%) | 1 (4%) | |
| Computed tomography | ||||
| Aortic annulus major diameter (mm) | 26.1 ± 2.3 | 26.2 ± 2.3 | 25.9 ± 2.2 | 0.466 |
| Aortic annulus minor diameter (mm) | 22.8 ± 2.0 | 23.0 ± 2.2 | 22.5 ± 1.4 | 0.364 |
| Aortic annulus mean diameter (mm) | 24.5 ± 1.6 | 24.6 ± 1.7 | 24.2 ± 1.3 | 0.291 |
| Eccentricity index † | 0.88 ± 0.10 | 0.88 ± 10 | 0.88 ± 0.09 | 0.867 |
| Aortic annulus area (mm 2 ) | 467 ± 45 | 465 ± 48 | 472 ± 37 | 0.615 |
| Aortic valve calcification (Agatston units) ‡ | 2072 ± 1247 | 2013 ± 1302 | 2294 ± 1036 | 0.526 |
∗ As measured by transesophageal echocardiography.
† Eccentricity index = major diameter/minor diameter.
The main procedural and in-hospital events after TAVR are listed in Table 4 . The rate of balloon postdilation after valve implantation was higher in the SXTV group (20%) compared with the S3V group (4%), p = 0.047. There were no differences between groups regarding periprocedural events albeit there was an absence of vascular complications in the S3V group as opposed to a rate of 14% in the SXTV patient (p = 0.542).
| Variables | All (n = 77) | Sapien XT (n = 50) | Sapien 3 (n = 27) | p Value |
|---|---|---|---|---|
| Approach | 0.406 | |||
| Transfemoral | 51 (66%) | 34 (68%) | 17 (63%) | |
| Transapical/transaortic | 26 (34%) | 16 (32%) | 10 (37%) | |
| Balloon post-dilation | 11 (14%) | 10 (20%) | 1 (4%) | 0.047 |
| Valve-in-valve | 0 | 0 | 0 | — |
| Stroke | 0 | 0 | 0 | — |
| Myocardial infarction | 0 | 0 | 0 | — |
| Major vascular complication | 2 (3%) | 2 (4%) | 0 | 1.000 |
| Minor vascular complication | 5 (7%) | 5 (10%) | 0 | 0.600 |
| Vascular complication (major/minor) | 7 (9%) | 7 (14%) | 0 | 0.542 |
The echocardiographic data after TAVR, overall and according to valve type, are listed in Table 5 . The overall mean transprosthetic gradient decreased from 38 ± 16 mm Hg to 11 ± 4 mm Hg (p <0.001), and the mean EOA increased from 0.64 ± 0.21 cm 2 to 1.42 ± 0.32 cm 2 (p <0.001) after TAVR. There were no differences between groups in residual transaortic mean gradient (p = 0.709) and on EOA (p = 0.10). In the S3V group, only 2 patients (7%) had a paravalvular leak graded as mild or greater, compared with 42% of the patients in the SXTV group (p = 0.002; Figure 1 and Figure 2 ). Global AR (paravalvular + transvalvular) ≥mild degree was of 11% in the S3V group compared with 44% in the SXTV group (p = 0.007).
| Variables | All (n = 77) | Sapien XT (n = 50) | Sapien 3 (n = 27) | p Value |
|---|---|---|---|---|
| Left ventricular ejection fraction (%) | 53 ± 12 | 53 ± 14 | 52 ± 9 | 0.511 |
| Heart rate (beats/min) | 74 ± 16 | 75 ± 16 | 67 ± 14 | 0.238 |
| Stroke volume (mL) | 63 ± 15 | 62 ± 14 | 69 ± 16 | 0.282 |
| Peak aortic gradient (mm Hg) | 20 ± 7 | 20 ± 7 | 23 ± 8 | 0.841 |
| Mean aortic gradient (mm Hg) | 11 ± 4 | 11 ± 4 | 11 ± 5 | 0.709 |
| Doppler velocity index | 0.34 ± 0.14 | 0.35 ± 0.13 | 0.31 ± 0.16 | 0.738 |
| Time to peak velocity (ms) | 83 ± 23 | 78 ± 22 | 98 ± 18 | 0.070 |
| Effective orifice area (cm 2 ) | 1.42 ± 0.32 | 1.42 ± 0.36 | 1.41 ± 0.23 | 0.100 |
| Systolic pressure of pulmonary artery (mm Hg) | 40 ± 16 | 40 ± 16 | 39 ± 16 | 0.974 |
| Paravalvular aortic regurgitation grade | 0.003 | |||
| None or trivial | 54 (70%) | 29 (58%) | 25 (93%) | |
| Mild | 19 (25%) | 17 (34%) | 2 (7%) | |
| Moderate | 4 (5%) | 4 (8%) | 0 | |
| Severe | 0 | 0 | 0 | |
| Aortic regurgitation ≥mild | 23 (30%) | 21 (42%) | 2 (7%) | 0.002 |
| Aortic regurgitation ≥moderate | 4 (5%) | 4 (8%) | 0 (0%) | 0.164 |
| Global aortic regurgitation grade | 0.008 | |||
| None or trivial | 52 (67%) | 28 (56%) | 24 (89%) | |
| Mild | 19 (25%) | 17 (34%) | 2 (7%) | |
| Moderate | 6 (8%) | 5 (10%) | 1 (4%) | |
| Severe | 0 | 0 | 0 | |
| Aortic regurgitation ≥mild | 25 (32%) | 22 (44%) | 3 (11%) | 0.007 |
| Aortic regurgitation ≥moderate | 6 (8%) | 5 (10%) | 1 (4%) | 0.448 |
| Mitral regurgitation grade | 0.742 | |||
| None or trivial | 36 (47%) | 24 (48%) | 12 (44%) | |
| Mild | 35 (45%) | 21 (42%) | 14 (52%) | |
| Moderate | 4 (5%) | 4 (8%) | 0 | |
| Severe | 2 (3%) | 1 (2%) | 1 (4%) |
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