Comparison of Two Different Valve Systems for TA-AVI - a Propensity Score Adjusted Analysis
Jörg Kempfert, Alexander Meyer, Won-Keun Kim, Arnaud van Linden, Mani Arsalan, Christoph Liebetrau, Helge Möllmann, Thomas Walther.
Kerckhoff Clinic, Bad Nauheim, Germany.
OBJECTIVE: Recently, several alternative transapical transcatheter aortic valve systems became commercially available in Europe. Data, directly comparing the performance of these different TA-AVI valves are sparse. Therefore, we sought to analyse performance of the long established balloon-expandable SAPIEN XT™ (Edwards Lifesciences) and compare to the more recently approved self-expandable ACURATE TA™ (Symetis S.A.) systems by means of propensity score analysis.
METHODS: In total, a consecutive sample of 182 patients treated with transapical TAVI have been included (2011-2013). The ACURATE valve was implanted in 42 % (n=97), SAPIEN in 58 % (n=135). In a first step univariate analysis has been performed. To adjust for baseline variables propensity score (PS) based inverse probability of treatment weighting has been used. In addition, potential anatomical confounders (calcification grade: CT-Agatston score, CT-effective annulus diameter) have been included within the PS estimation.
RESULTS: Mean age was 83.4±5.3 for ACURATE and 80.0±10.0 for SAPIEN patients (p=0.001). The STS-Score demonstrated no significant difference with 7.8±4.7 (ACURATE) and 8.3±6.3 (SAPIEN). All patients were treated within a multidisciplinary Heart Team. Propensity score adjustment resulted in reduction of the standardized mean difference below 0.2 indicating excellent balance allowing for valid outcome comparison between groups. All procedures were uneventful except the following severe complications leading to conversion. ACURATE: annular rupture=1; SAPIEN: device embolization n=2, apical rupture n=2, annular rupture n=1, coronary occlusion n=1.
30-day mortality rate (ACURATE: 8.0%, SAPIEN: 7.7%; adjusted OR 1.4, CI95 0.49-4.05) and 30-day stroke rate (ACURATE: 2.1%, SAPIEN: 7.4%; adjusted OR 0.24, CI95 0.05-1.20) were comparable. Necessity to perform a post-ballooning was significantly higher in the self-expandable group (ACURATE: 40.2%, SAPIEN: 12.6%; adjusted OR 4.27, CI95 2.06-8.9, p<0.001). Immediate postimplantation angiography revealed comparable rates of relevant paravalvular leaks (ACURATE: 6.2%, SAPIEN: 11.1%; adjusted OR 0.56, CI95 0.20-1.57). Echocardiography demonstrated slightly higher mean gradients in the ACURATE group (12.7±5.4mmHg versus SAPIEN 9.7mmHg±5.6, adjusted p=0.03). A new pacemaker was required in a comparable rate of patients (ACURATE: 8.4%, SAPIEN: 4.5%; adjusted OR 2.8421, CI95 0.93-8.70)
CONCLUSIONS: Overall, both transapical TAVI devices demonstrated comparable hemodynamical performance and clinical outcome. The self-expandable valve required more frequently post-ballooning without affecting the safety profile.
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