ATS
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to Personal Folders
Right arrow Download to citation manager
Right arrow Author home page(s):
George M. Palatianos
Axel M. Laczkovics
Paul Simon
Jose Luis Pomar
Dietrich E. Birnbaum
Hans H. Greve
Axel Haverich
Right arrow Permission Requests
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Palatianos, G. M.
Right arrow Articles by Haverich, A.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Palatianos, G. M.
Right arrow Articles by Haverich, A.
Related Collections
Right arrow Valve disease

Ann Thorac Surg 2007;83:40-46
© 2007 The Society of Thoracic Surgeons

Original Articles: Cardiovascular

Multicentered European Study on Safety and Effectiveness of the On-X Prosthetic Heart Valve: Intermediate Follow-Up

George M. Palatianos, MDa,*, Axel M. Laczkovics, MDb, Paul Simon, MDc, Jose Luis Pomar, MDd, Dietrich E. Birnbaum, MDe, Hans H. Greve, MDf, Axel Haverich, MDg

a Onassis Cardiac Surgery Center, Athens, Greece
b Universitatklinikum Bergmannsheil, Bochum, Germany
c AKH-Wien, Vienna, Austria
d University of Barcelona, Spain
e University Clinic, Regensburg, Germany
f Klinikum Krefeld, Krefeld, Germany
g Medical High School, Hanover, Germany

Accepted for publication August 3, 2006.

* Address correspondence to Dr Palatianos, Onassis Cardiac Surgery Center, 3rd Cardiac Surgery Department, 356 Sygrou Ave, Athens 176 74, Greece (Email: palatianos{at}otenet.gr).

BACKGROUND: This study was performed to determine the safety and effectiveness of the On-X valve, a novel mechanical valve substitute.

METHODS: Eleven centers participated in a European, multicentered, longitudinal, nonrandomized study of the On-X valve performance. Isolated aortic or mitral valve replacement with an On-X valve was studied in 301 patients. Aortic valve replacement was performed in 184 patients (average follow-up, 5.0 years), whereas mitral valve replacement was performed in 117 patients (average follow-up, 4.4 years).

RESULTS: In patients with aortic valve replacement, mean transvalvular pressure gradients ranged from 8.3 to 4.7 mm Hg and effective orifice areas from 1.5 to 2.7 cm2, for 19-mm through 25-mm valves, respectively. After mitral valve replacement, mean gradient was 4.2 mm Hg and effective orifice area by pressure half-time was 2.6 cm2 regardless of valve size. Hemolysis was low, with postoperative serum lactate dehydrogenase at 225 ± 41 IU (mean ± standard deviation) or 253 ± 65 IU, after aortic valve replacement or mitral valve replacement, respectively (upper normal value, 250 IU). At 1 year or greater postoperatively, 91.6% of patients after aortic valve replacement and 84.6% after mitral valve replacement were in New York Heart Association functional class I or II. Adverse event rates in percent per patient-year after aortic valve replacement or mitral valve replacement were thromboembolism, 0.88 or 1.76; thrombosis, 0.11 or 0.20; bleeding, 0.77 or 1.96, respectively. Late mortality was 1.97% or 2.55%, respectively.

CONCLUSIONS: At the intermediate follow-up, the On-X valve exhibited improved hemodynamics, low hemolysis with in-range lactate dehydrogenase, and low adverse event rates, particularly in the aortic position.






HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
ANN THORAC SURG ASIAN CARDIOVASC THORAC ANN EUR J CARDIOTHORAC SURG
J THORAC CARDIOVASC SURG ICVTS ALL CTSNet JOURNALS
Copyright © 2007 by The Society of Thoracic Surgeons.