Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN XT versus SAPIEN prostheses

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• 作者：Hé ; lè ; ne Eltchaninoff^a ; ^d ; ^{helene.eltchaninoff@chu-rouen.fr} ; É ; ric Durand^a ; Bogdan Borz^a ; Matthieu Godin^a ; Christophe Tron^a ; Pierre-Yves Litzler^b ; ^d ; Jean-Paul Bessou^b ; ^d ; Karim Bejar^a ; Chiara Fraccaro^a ; Carlos Sanchez-Giron^a ; Jean-Nicolas Dacher^c ; ^d ; Fabrice Bauer^a ; ^d ; Alain Cribier^a ; ^d
• 关键词：Aortic stenosis ; Transcatheter aortic valve implantation (TAVI) ; Valve Academic Research Consortium (VARC) ; SAPIEN XT prosthesis
• 刊名：Archives of Cardiovascular Diseases
• 出版年：2012
• 出版时间：March, 2012
• 年：2012
• 卷：105
• 期：3
• 页码：132-140
• 全文大小：535 K

文摘

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Summary

Background

A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex?delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis.

Aims

To evaluate periprocedural and 30-day clinical outcomes using the Edwards SAPIEN XT compared with the first-generation Edwards SAPIEN prosthesis.

Methods

Between May 2006 and October 2011, consecutive high-risk or non-operable patients with severe aortic stenosis had TAVI using an Edwards SAPIEN or SAPIEN XT prosthesis. Valve Academic Research Consortium endpoints were used.

Results

Of 250 patients who underwent TAVI, 190 were performed transfemorally (78 SAPIEN and 112 SAPIEN XT). Transfemoral access was possible more often using SAPIEN XT (112/123 [91.1 % ] vs 78/127 [61.4 % ]; P < 0.001). Mean logistic EuroSCORE was significantly lower in the SAPIEN XT group (18.1 ¡À 11.0 % vs 27.3 ¡À 11.1 % ; P < 0.0001), and the iliofemoral artery minimal lumen diameter was smaller (6.7 ¡À 1.2 vs 8.5 ¡À 1.3 mm; P < 0.0001). Device success was similar in both groups (95.5 % for SAPIEN XT and 93.6 % for SAPIEN), as was the 30-day combined safety endpoint (15.2 % and 17.9 % , respectively). At 30 days, prosthesis performance was similar in both groups.

Conclusions

Short-term safety and performance analysis of the latest generation of balloon-expandable valve, the SAPIEN XT, seem similar to the previous generation. However, transfemoral implantation is more often possible, related to sheath size reduction.