Transcatheter, inflatable, and fully repositionable aortic valve: Preliminary results using a modified implantation technique

• Published in: Catheterization and cardiovascular interventions 2016-02, Vol.87 (3), p.500-507
• Main Authors: Kische, Stephan, D'Ancona, Giuseppe, Agma, Hüseyin U., Gürer, Hakan, Ortak, Jasmin, Elsässer, Albrecht, Öner, Alper, Ince, Hüseyin
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aortic Valve - diagnostic imaging; Aortic Valve - pathology; Aortic Valve - physiopathology; aortic valve disease; Aortic Valve Insufficiency - etiology; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - therapy; Aortography; Balloon Valvuloplasty - adverse effects; Balloon Valvuloplasty - mortality; Calcinosis - diagnostic imaging; Calcinosis - mortality; Calcinosis - physiopathology; Calcinosis - therapy; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Cardiac Catheterization - methods; Cardiac Catheterization - mortality; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Heart Valve Prosthesis Implantation - mortality; Humans; Male; percutaneous intervention; Pressure; Prosthesis Design; structural heart disease intervention; TAVI percutaneous valve; Time Factors; Treatment Outcome
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.26039

Objectives We present our experience with an inflatable, non‐metallic, fully retrievable, and repositionable transcatheter aortic valve [Direct Flow® Medical (DFM)] focusing on technical features adopted during implantation. Background Implantation techniques of new generation percutaneous aortic valves are still developing and with experience implementations are described. Methods The “low pressure” (initial valve inflation at 4 ATM, lower than the recommended 12 ATM) and the “alternate aortic curve” techniques (initial valve pulling either from the wire running on the side of the inner or from the one on the outer aortic curve) are part of our modified protocol for DFM® implantation. Results Forty‐two consecutive patients underwent TAVI with DFM. The “low pressure” technique was used in all patients. In 27 (64.3%) patients the bulkiest calcifications were on the inner aortic curve side, and an inner curve technique was used to initiate valve pulling toward the annular hinge point. In the remaining 15 (35.7%) patients, an outer curve technique was used. Neither pull‐through nor re‐valving was reported. Valve performance showed mean gradient of 8.9 mm Hg. Mild paravalvular leak was reported in seven (16%) patients. No one experienced moderate or severe aortic insufficiency. Thirty‐day mortality was 9.5% (4/42). Conclusion The “low pressure technique” and the “alternate curve technique” guarantee an anatomy and patient tailored approach to achieve controlled and finely tuned valve seating. © 2015 Wiley Periodicals, Inc.