TY - JOUR
T1 - Early results after implantation of a new geometric annuloplasty ring for aortic valve repair
AU - Mazzitelli, Domenico
AU - Nöbauer, Christian
AU - Rankin, J. Scott
AU - Badiu, Catalin C.
AU - Krane, Markus
AU - Crooke, Philip S.
AU - Cohn, William E.
AU - Opitz, Anke
AU - Schreiber, Christian
AU - Lange, Rüdiger
N1 - Funding Information:
This phase I clinical trial was supported by BioStable Science and Engineering, Austin, Texas.
PY - 2013/1
Y1 - 2013/1
N2 - Background: Aortic valve repair is associated with fewer long-term valve-related complications as compared with valve replacement, and repair is being performed increasingly. A current problem is the lack of a geometric annuloplasty ring to facilitate reconstruction. This paper describes the first clinical application of such a device designed to permanently restore physiologic annular size and geometry during aortic valve repair. Methods: Based on mathematical studies of human cadaver valves, as well as computed tomography angiographic analyses of awake patients with normal valves, a three-dimensional annuloplasty ring has been developed, consisting of low-profile, one-piece titanium construction and Dacron cloth covering. The ring design incorporates 2:3 elliptical base geometry and 10-degree outwardly flaring subcommissural posts. Results: Appropriately sized rings were implanted in 5 patients with severe aortic insufficiency due to annular dilation and anatomic leaflet defects. The rings restored annular geometry and facilitated leaflet repairs in all patients. Each recovered excellent valve function with minimal residual leak. All patients convalesced uneventfully, were discharged within 7 days after surgery, and continue with stable valve function as long as 6 months after implantation. Conclusions: Initial clinical application of a geometric aortic annuloplasty ring was associated with excellent device performance and perhaps better repairs. Further clinical series and patient follow-up should identify potential benefits of the device, including improved applicability and stability of aortic valve repair.
AB - Background: Aortic valve repair is associated with fewer long-term valve-related complications as compared with valve replacement, and repair is being performed increasingly. A current problem is the lack of a geometric annuloplasty ring to facilitate reconstruction. This paper describes the first clinical application of such a device designed to permanently restore physiologic annular size and geometry during aortic valve repair. Methods: Based on mathematical studies of human cadaver valves, as well as computed tomography angiographic analyses of awake patients with normal valves, a three-dimensional annuloplasty ring has been developed, consisting of low-profile, one-piece titanium construction and Dacron cloth covering. The ring design incorporates 2:3 elliptical base geometry and 10-degree outwardly flaring subcommissural posts. Results: Appropriately sized rings were implanted in 5 patients with severe aortic insufficiency due to annular dilation and anatomic leaflet defects. The rings restored annular geometry and facilitated leaflet repairs in all patients. Each recovered excellent valve function with minimal residual leak. All patients convalesced uneventfully, were discharged within 7 days after surgery, and continue with stable valve function as long as 6 months after implantation. Conclusions: Initial clinical application of a geometric aortic annuloplasty ring was associated with excellent device performance and perhaps better repairs. Further clinical series and patient follow-up should identify potential benefits of the device, including improved applicability and stability of aortic valve repair.
UR - http://www.scopus.com/inward/record.url?scp=84871915673&partnerID=8YFLogxK
U2 - 10.1016/j.athoracsur.2012.08.034
DO - 10.1016/j.athoracsur.2012.08.034
M3 - Article
C2 - 23063198
AN - SCOPUS:84871915673
SN - 0003-4975
VL - 95
SP - 94
EP - 97
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 1
ER -