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Archives of cardiovascular diseases
Volume 111, n° 8-9
pages 470-479 (août 2018)
Doi : 10.1016/j.acvd.2017.05.012
Received : 13 June 2016 ;  accepted : 12 May 2017
Clinical research

Transfemoral aortic valve implantation is more successful with the Edwards Sapien 3 compared with the Edwards XT for the treatment of symptomatic severe aortic stenosis
Implantation transfémorale d’une valve aortique Edwards Sapien versus Edwards XT pour le traitement d’une sténose aortique sévère symptomatique
 

Birgid Gonska, Julia Seeger, Alexander Junker, Christoph Rodewald, Ulrike Trepte, Dominik Scharnbeck, Wolfgang Rottbauer, Jochen Wöhrle
 Department of Internal Medicine II – Cardiology, University of Ulm, Ulm, Germany 

Corresponding author.
Summary
Background

Residual aortic regurgitation (AR) after transfemoral aortic valve implantation (TAVI) is associated with increased mortality. The new Edwards Sapien 3 valve (ES3) is designed to reduce paravalvular AR.

Aim

To compare a new-generation and a late-generation balloon-expandable transcatheter heart valve.

Methods

In this study, 100 consecutive patients treated with the ES3 for symptomatic native severe aortic stenosis were compared with 100 consecutive patients treated with the Edwards Sapien XT valve (EXT); all valves were implanted via transfemoral access. We compared residual AR, rate of permanent pacemaker implantation, device success according to the second Valve Academic Research Consortium (VARC-2) criteria and 30-day follow-up.

Results

With the ES3, the risk of moderate/severe AR was lower (0% vs 3%), the risk of mild AR was lower (31% vs 40%) and the final result with no AR was higher (P =0.07). The mean aortic gradient was significantly higher with the ES3 (12.2±4.6 vs 9.4±3.9mmHg; P <0.01). Device success according to the VARC-2 criteria was high with the ES3 and the EXT (97% vs 95%; P =0.48). Pacemaker implantation because of higher-grade atrioventricular block was similar: 9.3% after ES3 implantation and 6.9% after EXT implantation (P =0.56). There was significantly less major or life-threatening bleeding with the ES3: 5% vs 14% (P =0.03) and 0% vs 8% (P <0.01), respectively. After 30 days, the VARC-2 early-safety endpoint was significantly lower with the ES3 (P <0.01).

Conclusions

In conclusion, TAVI with the ES3 in patients with symptomatic severe aortic stenosis was associated with no moderate/severe AR, a trend towards a lower rate of mild AR, a significantly lower rate of major or life-threatening bleeding and early safety according to VARC-2 criteria within 30 days compared with the EXT.

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Résumé
Justification

La présence d’une régurgitation aortique résiduelle au décours de l’implantation percutanée d’une valve aortique (TAVI) est associée à une surmortalité. La valve Edwards Sapien 3 (ES3) a été imaginée pour réduire la fuite aortique paravalvulaire.

Objectifs

Comparer la nouvelle génération de valve aortique ES3 avec une valve aortique plus ancienne.

Méthode et résultats

Cette étude a inclus 100 patients consécutifs avec l’implantation de la valve aortique ES3, porteurs d’une sténose aortique sévère symptomatique qui ont été comparés à 100 patients consécutifs traités avec une valve conventionnelle, Edwards Sapien XT (EXT). Ces valves ont été implantées par voie transfémorale. La prévalence de la régurgitation aortique résiduelle, du taux d’implantation de stimulateur cardiaque permanent ainsi que le taux de succès, conformément aux recommandations VARC-2 ont été réalisées, lors d’un suivi de 30jours. Avec la valve aortique ES3, le risque de régurgitation moyenne à sévère est moindre (0 versus 3%), ainsi que le risque de fuite aortique modérée (31 versus 40%) et la fuite aortique n’est pas significativement différente avec les 2 valves (P=0,07). Le gradient transaortique moyen est significativement plus élevé avec la valve aortique ES3 versus EXT (12,2±4,6mmHg versus 9,4±3,9mmHg, P<0,01). Le taux de succès de déploiement est plus élevé avec la valve ES3, versus EXT (97 versus 95%, P=0,48). Le taux d’implantation permanent de stimulateur cardiaque du fait d’un bloc auriculo ventriculaire de haut degré n’est pas significativement différent, 9,3% avec ES3, 6,9% avec EXT (P=0,56). Le taux de saignement majeur est significativement moindre avec la valve ES3, 5% versus 14% avec la valve EXT, P=0,03; Il en est de même pour les saignements potentiellement léthaux, 0 versus 8%, P<0,01. Au terme du suivi de 30jours, le critère de jugement de sécurité selon VARC 2 est significativement moindre avec la valve ES3, comparativement à la valve EXT (P<0,001).

Conclusion

Le remplacement valvulaire aortique percutané (TAVI) avec une valve ES3 chez les patients porteurs d’une sténose aortique symptomatique et sévère est associé avec un taux moindre de régurgitation aortique moyenne à sévère, et avec une tendance à un risque moindre de fuite aortique, de régurgitation aortique modérée. Il est également observé un taux moindre de saignement majeur ou à risque léthal, indiquant que la sécurité précoce selon les critères VARC 2 à 30jours est meilleure avec la valve Edwards Sapiens 3 (ES3), comparativement à la valve Edwards Sapiens XT (EXT)

The full text of this article is available in PDF format.

Keywords : Aortic valve stenosis, Transcatheter aortic valve replacement, Aortic regurgitation

Mots clés : Sténose valvulaire aortique, Remplacement valvulaire aortique par voie percutanée (TAVI), Régurgitation aortique

Abbreviations : AR, ES3, EXT, LVOT, STS, TAVI, VARC-2


Background

Transfemoral aortic valve implantation (TAVI) for the treatment of patients with symptomatic severe aortic stenosis is a well-proven treatment option for patients at high risk of surgical valve replacement. Mortality with TAVI using the balloon-expandable Edwards Sapien and Edwards Sapien XT (EXT) valves (Edwards Lifesciences, Irvine, CA, USA) was similar to surgical aortic valve replacement in the randomized PARTNER trial within 5 years [1], and was significantly lower using the CoreValve prosthesis (Medtronic, Minneapolis, MN, USA) in the US CoreValve High Risk Study [2] within 3 years. Recent data on patients with an intermediate risk showed a similar TAVI outcome with the EXT compared with surgical valve replacement [3]. Residual moderate or severe aortic regurgitation (AR) after TAVI with the EXT or the CoreValve was reported as being between 4% and 29% [2, 4, 5, 6, 7, 8, 9, 10]. Residual moderate or severe paravalvular AR after TAVI has been identified as an independent predictor of mortality [3], and in an analysis from the PARTNER 2 trial, even mild paravalvular AR was associated with higher mortality [7]. Transcatheter aortic valve implantation with first-generation devices had higher rates of major vascular and bleeding complications than surgical valve replacement. Major vascular complications have also been identified as independent predictors of mortality [11].

The balloon-expandable Edwards Sapien 3 valve (ES3) (Edwards Lifesciences, Irvine, CA, USA) has a specific design (an outer skirt of polyethylene terephthalate) that is dedicated to reducing paravalvular AR. Furthermore, the frame geometry has been enhanced to allow better positioning and a lower-profile delivery system, with the aim of reducing vascular complications. The valve is available in three sizes (23, 26 and 29mm), therefore covering a native aortic diameter of 18–28mm; the sheaths are expandable, with sizes of 14 French for the 23 and 26mm valve and 16 French for the 29mm valve.

We evaluated the results of patients with severe symptomatic aortic stenosis undergoing TAVI with the ES3 compared with the EXT in terms of the combined 30-day early-safety endpoint, according to the criteria of the second Valve Academic Research Consortium (VARC-2) (composite of all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury stage 2 or 3, coronary artery obstruction requiring intervention, major vascular complications and valve-related dysfunction requiring repeat procedure). In addition, we analysed the rate of postprocedural AR, the need for a permanent pacemaker and device success after TAVI according to the VARC-2 criteria [12].

Methods

The first 100 consecutive patients treated with the ES3 were compared with the last 100 consecutive patients treated with the EXT. ES3s were implanted in 2014; EXT procedures were performed in 2013/2014 in the period before the release of the ES3. Both valves were available in 23, 26 and 29mm sizes (Figure 1, Figure 2), and were implanted via transfemoral access. All patients had symptomatic severe native aortic stenosis, documented by echocardiography, and cardiac catheterization, with an aortic valve area ≤1cm2 or an indexed aortic valve area ≤0.6cm2/m2. Patients were at high risk of surgical valve replacement, based on a Society of Thoracic Surgeons (STS) predicted risk of mortality score, or had relevant co-morbidities with contraindications to surgical valve replacement e.g. porcelain aorta, frailty or history of chest radiation. The decision for TAVI was made by the heart team, which included cardiologists and heart surgeons. Written informed consent was obtained from each patient, and the study was approved by the local ethics committee. Patients were enrolled prospectively in the Coronary and Structural Interventions-Ulm-Transcatheter Aortic Valve Replacement (CSI-Ulm-TAVR) study (clinicaltrials.gov NCT02162069).



Figure 1


Figure 1. 

The Edwards Sapien XT valve.

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Figure 2


Figure 2. 

The new-generation Edwards Sapien 3 valve, with an outer skirt of polyethylene terephthalate to reduce paravalvular aortic regurgitation.

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Preprocedural 256 multislice computed tomography (Brilliance i-CT256; Philips, Amsterdam, The Netherlands) was used for sizing in all patients. Measurements of aortic annulus, left ventricular outflow tract (LVOT), distance from annulus to coronary ostia, area at the sinotubular junction and area at the ostia of the coronary arteries were obtained by using dedicated software (3mensio, version 7.0; Pie Medical Imaging, Maastricht, The Netherlands). Measurements were performed in systole. Oversizing or undersizing was calculated as % oversizing=(ES3 nominal area/annular area by computed tomography1)×100. Nominal areas for the 23, 26 and 29mm EXTs were 415, 531 and 661mm2, respectively, and for the 23, 26 and 29mm ES3s were 406, 519 and 649mm2, respectively [13, 14]. Aortic cusp calcification was assessed according to Rosenhek et al. [15]. TAVI procedures were performed under local anaesthesia and mild sedation in the hybrid catheterization laboratory, as described elsewhere [16, 17, 18]. The aortic valve was implanted with fluoroscopic guidance and rapid pacing in the orthogonal view of the annulus. Angulation for orthogonal view was obtained by prior measurement of the computed tomography. After implantation, the device function was evaluated by standardized aortography [19], invasive haemodynamic measurements and echocardiography. For the aortography, the pigtail catheter was placed on top of the valve. AR was quantified by the modified Sellers criteria [19, 20]. Transthoracic echocardiography for final postprocedural grading of AR was performed by a cardiologist specialized in non-invasive cardiac imaging. AR was graded as none, trace, mild, moderate or severe, as proposed by Zoghbi et al. for a task force on prosthetic valves for the echocardiographic associations [21].

Postprocedural outcome was analysed according to the VARC-2 criteria [12], evaluating postprocedural AR, device success, need for permanent pacemaker implantation and outcome within 30 days. Device success was defined as the absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical position and intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient<20mmHg or peak velocity<3m/s, and no moderate or severe prosthetic valve regurgitation). Patients were followed for 30 days to assess early safety according to VARC-2 criteria.

Statistical analysis

Sample size calculation was based on assumed incidences of the primary early-safety endpoint for the EXT [22] and the ES3 [16], with a power of 80% and an α -level of 0.05. The smallest possible number was chosen to minimize the impact of difference in implantation period for each device. For statistical analyses, we used Statistica software, version 10 (Stat Soft, Inc., Tulsa, OK, USA). Categorical variables are presented as counts and percentages, and differences between proportions were calculated using the χ 2 test. Continuous variables were tested for normal distribution using the Shapiro–Wilks test. Data with normal distribution are expressed as mean±one standard deviation, and were compared with the t test; non-normally distributed data are presented as median and interquartile range, and were compared using the Mann–Whitney U test. A P value<0.05 was considered statistically significant.

Results

Baseline clinical characteristics in the ES3 and EXT groups were similar (Table 1), except for a significantly higher percentage of women in the EXT group. History of cardiac surgery and presence of pulmonary disease or atrial fibrillation did not differ. About one-third of patients in both groups had an ejection fraction<45%. The STS predicted risk of mortality score was significantly higher for the ES3 group: 7.8% (interquartile range 4.8–11.4) versus 5.2% (interquartile range 3.2–8.0%) in the EXT group (P <0.01). Transthoracic echocardiography and cardiac catheterization showed severe aortic stenosis (Table 2). Detailed analyses of the multislice computed tomography showed similar results for area-derived diameter, perimeter-derived diameter, area and perimeter of the aortic annulus and the LVOT, area at the sinotubular junction and area at the ostia of the coronary arteries, as detailed in Table 3. Furthermore, the degrees of aortic cusp calcification and calcification of the LVOT (Table 3) were similar between the groups. Severe cusp calcification (Rosenhek IV) was similar in both groups. There was a significantly higher degree of oversizing with the EXT compared with the ES3 (10.9±15.4% vs 5.8±12.5%; P =0.042).

Procedural results

In both groups, the 26mm valve size was used most often (Table 4). The ES3 was successfully implanted in all 100 patients, with no need for balloon postdilation or implantation of a second valve. In the EXT group, one patient needed a second valve because of relevant AR. In both groups there was no procedural death, coronary obstruction, annular rupture or need for conversion to surgery. Implantation depth with the EXT was low (5.69±2.41mm), and did not differ significantly from the implantation depth with the ES3 (6.07±2.34mm; P =0.78). Moderate or severe AR after valve implantation was completely absent with the ES3, as assessed by aortography and echocardiography (Table 4, Table 5). Three patients (3%) had moderate paravalvular AR after EXT implantation, as assessed by echocardiography, 1 day after TAVI. Furthermore, there was a statistical trend for a higher rate of no AR and a lower rate of mild AR with the ES3 compared with the EXT (Table 5).

The rate of device success according to the VARC-2 criteria was high in both groups (95% for the EXT and 97% for the ES3; P =0.48). The three patients who did not achieve device success after implantation of the ES3 had elevated mean aortic gradients>20mmHg after implantation of a 26mm valve (n =1) or a 23mm valve (n =2). Overall, the mean aortic gradient was significantly higher with the ES3 compared with the EXT (Table 5). In the EXT population, one patient had an elevated mean aortic gradient>20mmHg after implantation of a 23mm valve, three patients had postprocedural moderate AR and one patient needed a second valve implantation.

Thirty-day outcome data are shown in Table 6. In patients without a preprocedural pacemaker, permanent pacemaker implantation was performed in 14% after ES3 implantation compared with 24% after EXT implantation (P =0.18). The need for pacemaker implantation because of second-degree atrioventricular block type II or third-degree atrioventricular block did not differ statistically (9.3% after ES3 implantation vs 6.9% after EXT implantation; P =0.56). In the other cases, the decision for permanent pacemaker implantation was made mostly because of the combination of complete left bundle branch block and first-degree atrioventricular block.

The early-safety endpoint at 30 days was met significantly less frequently after the implantation of the ES3 compared with the EXT (10% vs 25%; P <0.01), based on a lower rate of all-cause mortality (3% vs 7%; P =0.12), a lower rate of major vascular complications (5% vs 16%; P =0.11) and a significantly lower rate of major bleeding (5% vs 14%; P =0.03) or life-threatening bleeding (0% vs 8%; P <0.01).

Discussion

The new ES3 was superior to the EXT for TAVI in patients with symptomatic severe native aortic stenosis. The ES3 was associated with a significantly lower risk of bleeding events within 30 days, translating into a significantly lower rate of the early-safety endpoint according to the VARC-2 criteria. In our study, there was no moderate or severe AR with the ES3, and there was a trend towards a lower rate of mild AR and a higher rate of no or trace AR with the ES3 compared with the EXT.

A recent study-level meta-analysis, including 45 studies with about 13,000 patients, reported a cumulative incidence of moderate or severe AR of about 12% with different valve types [5]. The risk of moderate or severe AR after TAVI with the balloon-expandable Edwards valve has been reported to range between 4% and 14% [4, 7, 10, 23]. Moderate and severe postprocedural AR was associated with higher 30-day and 1-year mortality [5]. Data from the randomized PARTNER trial reported a higher 1-year mortality rate for even mild AR compared with no residual AR [7]. The new ES3 is a dedicated valve designed to optimize positioning and reduce the risk of paravalvular AR because of an outer skirt [24]. We were able to demonstrate that the ES3 eliminates the risk of postprocedural moderate or severe AR compared with the EXT. The elimination of moderate or severe AR with the ES3 was also demonstrated in an early series of 15 patients [25], and in a retrospective analysis of 51 patients treated with the ES3 via transfemoral access [26]. Another group reported on 54 patients treated with the ES3 via transapical and transaortic access: there was no severe AR, and a 2.2% rate of moderate AR, with no need for postdilation [27]. Amat-Santos et al. evaluated 27 patients who underwent TAVI with the ES3, showing no moderate and only 7% mild paravalvular AR, although there was a need for balloon postdilation in 4% of patients [28]. A prospective study with 150 patients treated with the ES3 (96 via transfemoral access, 54 via transapical or transaortic access) reported 74.3% no or trace AR, 22.1% mild AR and 3.5% moderate AR at 30 days after implantation [13]. Data from the PARTNER II Sapien 3 trial, published by Kodali et al. in 2016, and evaluating 1661 patients treated with the ES3 at 51 sites in the USA and Canada, also showed no severe AR, a low rate (3.4%) of moderate AR and a 55.9% rate of no or trace AR [29].

Many trials have reported a higher risk of moderate or severe AR with older generations of the balloon-expandable Edwards valve without the outer skirt. In the SOURCE XT Registry, which included 2688 patients, the rate of moderate or severe paravalvular leak was 5.5% [10]. In inoperable patients treated in the PARTNER trial, the rate of moderate or severe paravalvular AR was 12.5% [30], and 12.3% in the randomized PARTNER trial that included patients with high surgical risk [31]. Two recently published comparisons of new-generation transcatheter heart valves with older generation devices showed a significant reduction in residual AR with the newer-generation transcatheter heart valves [32, 33]. There may be difficulties and uncertainties for evaluation of AR by echocardiography after TAVI (e.g. acoustic shadowing caused by the stent frame or calcification of the native valve). In addition, the short-axis view of the transcatheter heart valve by transthoracic echocardiography is sometimes limited for evaluation of the extent of AR in relation to the circumference, which may lead to a difficult quantification of paravalvular AR.

The strongest predictor of death in the TAVI group of the PARTNER trial was the presence of mild-to-severe paravalvular AR, with a hazard ratio of 2.11 (95% confidence interval 1.43–3.10; P <0.001) [31]. In our series of 200 patients, there was a lower rate of 30-day mortality with the ES3 compared with the EXT, but without statistical significance. Long-term follow-ups are necessary to evaluate whether the elimination of moderate and severe AR with the ES3 will translate into a continued reduced mortality rate.

Residual moderate or severe paravalvular AR after TAVI often triggers the need for balloon postdilation, which has been shown to be associated with a higher incidence of cerebrovascular events [34, 35, 36]. Nombela-Franco et al. evaluated 211 patients who underwent TAVI with a balloon-expandable valve. Balloon postdilation was performed in about one fourth of the patients, who had a significantly higher incidence of cerebrovascular events (11.9% vs 2.0% in patients without postdilation; P =0.006) [36]. Furthermore, in 2135 patients treated with the Edwards Sapien valve, the need for postdilation was 12.4%. Postdilation was associated with a significantly higher rate of subacute stroke compared with no postdilation (4.9% vs 2.6%; P =0.04) [35]. Daneault et al. demonstrated in 259 patients a non-significantly higher incidence of cerebrovascular events of 4.7% after balloon postdilation compared with 1.3% without postdilation (P =0.13) [34]. As a result of the elimination of moderate and severe AR with the ES3, the need for postdilation is also reduced, which might have an impact on the low reported risk of cerebral ischaemic events in our and other series [13].

Analyses from the PARTNER trial identified major vascular complications as an independent predictor of mortality [11]. Rates of major of life-threatening bleeding events were significantly lower with the ES3 compared with the EXT, which can be linked to the lower profile of the delivery system with the ES3 versus the EXT.

In our population, the rate of pacemaker implantation with the ES3 was lower compared with the EXT. However, early publications on the ES3 showed higher rates of pacemaker implantation with the ES3 than with the EXT. With the Edwards Sapien/EXT, the rate of permanent pacemaker implantation varied from 6.8% to 17.3% [4, 34]. The rate of pacemaker implantation was 6.8% with the Edwards Sapien/EXT in a meta-analysis (n =2732) [37], 8.5% with the EXT in the PARTNER 2 study (n =1011) [3], 9.5% in the SOURCE XT Registry (n =2688) [10] and up to 17.3% in the CHOICE trial [4]. The rate of pacemaker implantation with the ES3 has been reported as ranging from 11.2% in the PARTNER II SAPIEN 3 trial [29] up to 25.5% in a retrospective analysis by Murray et al. (n =51) [26]. A possible reason for higher pacemaker implantation rates with the ES3 could be deeper implantation into the LVOT. De Torres-Alba et al. showed that with high implantation of the ES3 in the LVOT there was less need for a pacemaker, and no significant difference in the pacemaker implantation rate after TAVI with the ES3 and the EXT [38]. In our study, implantation depths did not differ between the EXT and the ES3.

Indications for a permanent pacemaker differ between institutions, but should be similar for the occurrence of second-degree atrioventricular block type II or third-degree atrioventricular block. In our population, the need for a permanent pacemaker because of new higher-grade atrioventricular block was similar with the ES3 and the EXT.

To prevent the occurrence of paravalvular AR, a certain degree of oversizing of the valve in relation to the native aortic annulus is necessary [39, 40]. However, severe oversizing is associated with an increased risk of the occurrence of annular rupture [41], conduction disturbances and the need for pacemaker implantation [40, 42]. In our population, the degree of oversizing in relation to the annulus area was significantly lower with the ES3 compared with the EXT; this reduces the risk of annular rupture and the occurrence of total atrioventricular block. In addition, with the outer skirt, the rates of relevant residual paravalvular AR are minimized with the ES3. This finding is supported by data from Kazuno et al. [43], who concluded that with the ES3, a lesser degree of oversizing is necessary to achieve good results without residual paravalvular AR, which reduces the risk of severe complications, such as annulus rupture.

Study limitations

This was a single-centre non-randomized comparison of the ES3 with the EXT, limited by a small sample size. Furthermore, it was a historical comparison with regard to the group of patients treated with the EXT, with the limitation of possible changes in concomitant peri-interventional treatment with the ES3 in contrast to the EXT, which might have had an additional impact on difference in outcome.

Conclusions

Transfemoral TAVI with the ES3 in patients with symptomatic severe aortic stenosis is associated with a significantly lower rate of major life-threatening bleeding, leading to a significantly lower rate of the combined early-safety endpoint compared with the EXT. Furthermore, the ES3 showed no moderate or severe AR, and a trend towards a lower rate of mild AR.

Sources of funding

None.

Disclosure of interest

The authors declare that they have no competing interest.

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