| J Am Coll Cardiol Intv, 2010; 3:859-866 Anatomic Suitability for Present and Next Generation Transcatheter Aortic Valve Prostheses |
Evidence for a Complementary Multidevice Approach to Treatment
Hasan Jilaihawi, BSc (Hons), MBChB, Raoul Bonan, MD, Anita Asgar, MD, Réda Ibrahim, MD, Tomasz Spyt, MD, Derek Chin, MBBS, Jan Kovac, MD.Objectives: This study sought to assess the proportion of patients anatomically suitable for transcatheter aortic valve implantation by multiple access approaches.
Background: The devices currently in mainstream use for transcatheter treatment of severe aortic stenosis are those of Edwards (Edwards Lifesciences, Nyon, Switzerland) and Medtronic CoreValve (M-C) (Luxembourg City, Luxembourg). The range of patients that these can presently treat requires elucidation to guide the necessary evolution of these technologies and increase their scope of therapy.
Methods: A consecutive series of patients were assessed with transthoracic or transesophageal echocardiography and invasive angiography to assess anatomical suitability by different approaches. The transfemoral access requirements for Edwards and M-C (Edwards currently 22- and 24-F, soon to be 18- and 19-F; M-C 18-F) as well as the aortic valve annular criteria (18 to 25 mm and 20 to 27 mm, respectively) were incorporated in this assessment. Patients unsuitable for the transfemoral approach were considered for Edwards transapical and M-C transaxillary and direct ascendingaortic access. Patients suitable for these devices and access approaches were identified.
Results: Data were analyzed for 100 consecutive patients. Edwards suitability was 28% for Edwards-Sapien transfemoral, 78% for Edwards Novaflextransfemoral, and 88% for Edwards-Sapien transapical. Medtronic CoreValve suitability was 84% for transfemoral and 89% using additional transaxillary and direct aortic approaches. Of the 12 patients unsuitable for Edwards-based procedures, 8 were suitable for M-C. Of the 11 patients unsuitable for M-C–based techniques, 8 were suitable for Edwards. Only 3% were anatomically unsuitable for all approaches.
Conclusions: In this series, 97% of patients were anatomically suitable for a complementary approach to treatment.
Suggested case selection algorithm for contemporary 2-device approach to transcatheter aortic valve implantation: (blue) "Edwards track"; (red)"CoreValve track." Multiple approaches increase the number of patients anatomically suitable for at least 1 transcatheter aortic valve implantation approach. CT = computed tomography; LVOT = left ventricular outflow track.
Figure 5: Newer Devices Studied
(A) The Novaflex system. This new system facilitates reduction in profile for the Edwards XT device to 18- and 19-F for 23- and 26-mm prostheses, respectively. (A, Top) The stented valve is crimped ex vivo onto catheter shaft. (A, Middle) The delivery system facilitates advancement of stented valve onto balloon in vivo. (A, Bottom) The stented valve is deployed at the level of the aortic annulus. (B) The Medtronic Ventor system, a self-expanding transapical device.
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