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SURGICAL HEART VALVES CLINICAL DATA

MECHANICAL HEART VALVES

Unique design features have established Abbott mechanical heart valves—including the Regent™ and Masters Series—as a gold standard for reliability and performance, while maintaining low complication rates over the long term.

SURGICAL HEART VALVES

MECHANICAL HEART VALVES CLINICAL DATA

Unique design features have established Abbott mechanical heart valves—including the Regent™ and Masters Series—as a gold standard for reliability and performance, while maintaining low complication rates over the long term.

DEMONSTRATED SAFETY OVER NOTABLY LONG-TERM STUDIES

Abbott mechanical heart valves deliver exceptional hemodynamics and performance while maintaining low complication rates over the long term. The Abbott mechanical heart valves have demonstrated low late mortality and a low incidence of valve-related events over a period of at least 30 years.1,2

 Aortic Valve ReplacementMitral Valve Replacement
Retrospective Study950 patients, 30 years1,255 patients, 30 years
Thromboembolism0.56%/pt-year0.99%/pt-year
Thrombosis0.02%/pt-year0.03%/pt-year
Bleeding Event0.27%/pt-year0.43%/pt-year

READ THE SAITO ABSTRACT

 Aortic Valve ReplacementMitral Valve Replacement
Retrospective Study584 patients, 30 years439 patients, 30 years
Thromboembolism1.7%/pt-year2.9%/pt-year
Thrombosis*0.2%/pt-year0.1%/pt-year
Bleeding Event2.4%/pt-year2.0%/pt-year

*Calculated values.

READ THE JOHNSON ABSTRACT

AORTIC ANTICOAGULATION MANAGEMENT

A demonstrated worldwide history of excellence over a wide INR range

Click to read the abstracts

SAITO LOWERING-ITESCAT IIIEMERY

*44/197 patients in the Lowering-IT study were implanted with Abbott Valves.
†This was further stratified into a control group, a very low INR (monitored 1x weekly), and a very low INR (monitored 2x weekly) group.
§Thromboembolic events for VL1 and VL2 groups are listed together, respectively.
Bleeding events for VL1 and VL2 groups are listed together, respectively.
 

MAT-2202033 v1.0 | Item approved for Global OUS use.

References
  1. Saito S, Tsukui H, Iwasa S, et al. Bileaflet mechanical valve replacement: an assessment of outcomes with 30 years of follow-up. Interact Cardiovasc Thorac Surg. 2016;23(4):599-607. doi: 10.1093/icvts/ivw196
  2. Johnson S, Stroud MR, Kratz JM, et al. Thirty-year experience with a bileaflet mechanical valve prosthesis. J Thorac Cardiovasc Surg. 2018;157(1):213-222. doi: 10.1016/j.jtcvs.2018.09.002
  3. Torella M, Torella D, Chiodini P, et al. LOWERing the INtensity of oral anticoaGulant Therapy in patients with bileaflet mechanical aortic valve replacement: results from the "LOWERING-IT" Trial. Am Heart J. 2010;160(1); 171-178. doi: 10.1016/j.ahj.2010.05.005
  4. Koertke H, Zittermann A, Wagner O, et al. Efficacy and safety of very low-dose self-management of oral anticoagulation in patients with mechanical heart valve replacement. Ann Thorac Surg. 2010;90(5):1487-1493.
  5. Emery RW, Krogh CC, Arom KV, et al. The St. Jude Medical cardiac valve prosthesis: a 25-year experience with single valve replacement. Ann Thorac Surg. 2005;79(3):776-82. doi: 10.1016/j.athoracsur.2004.08.047
     
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