Comparison of Systematic Predilation, Selective Predilation, and Direct Transcatheter Aortic Valve Implantation With the SAPIEN S3 Valve

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• 作者：Marco Spaziano ; MD^&lowast ; ; Fadi Sawaya ; MD^&lowast ; ; Bernard Chevalier ; MD ; Andrew Roy ; MD ; Antoinette Neylon ; MD ; Philippe Garot ; MD ; Thomas Hovasse ; MD ; Hakim Benamer ; MD ; Mauro Romano ; MD ; Thierry Unterseeh ; MD ; Erik Bouvier ; MD ; Bertrand Cormier ; MD ; Marie-Claude Morice ; MD ; Thierry Lefè ; vre ; MD ; ^{t.lefevre@angio-icps.com}
• 刊名：Canadian Journal of Cardiology
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：33
• 期：2
• 页码：260-268
• 全文大小：728 K
• 卷排序：33

文摘

Despite previously described feasibility, direct transcatheter aortic valve implantation (TAVI) with the Edwards SAPIEN S3 device (S3-THV) (Edwards Lifesciences, Irvine, CA) has not been compared with either a systematic or a selective predilation approach.MethodsPatients undergoing predilation were divided into a systematic group (regardless of anatomic features) and a selective group (in the context of high valvular calcium burden). Both groups were matched in a 2:1 fashion to patients who underwent direct TAVI. Outcomes were assessed according to Valve Academic Research Consortium 2 (VARC-2) criteria.ResultsTwo hundred eighty-one patients underwent TAVI with the S3-THV in our centre. Of these patients, 58 underwent predilation before device implantation (systematic, n = 26; selective, n = 32). Procedural success was achieved in all patients. Patients in the selective predilation group had severe valve calcification volume—more than double that of the systematic group (445 ± 306 mm3 vs 970 ± 578 mm3, respectively; P < 0.0001).There was a trend for less dilation after the procedure in the systematic group compared with the selective group (4% vs 19%, respectively; P = 0.09). Device malposition necessitating a second device to be implanted occurred in 3 cases of direct TAVI (5%) and in none of the patients undergoing predilation (P = not significant). Thirty-day and 1-year mortality rates were similar between the patients who underwent direct TAVI and their predilation counterparts.ConclusionsIn patients with a moderate aortic valve calcification burden, direct TAVI appears to be feasible and safe. In those with high calcium burden, predilation should be considered after taking into account individual risk profiles.