ken
Well-known member
http://ats.ctsnetjournals.org/cgi/content/abstract/83/1/40
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: [email protected]).
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.
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: [email protected]).
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.
