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Standardized Technique of Aortic Valve Re-implantation for Valve-sparing Aortic Root Replacement
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Five-year follow up of the ATS mechanical heart valve

Robert W Emery1, Christopher C Krogh, Deb J Jones

  • 1Cardiac Surgical Associates, P. A., St. Paul, MN 55114, USA. dremery@csa-heart.com

The Journal of Heart Valve Disease
|April 17, 2004
PubMed

Insights

The ATS mechanical prosthesis shows excellent intermediate-term results for aortic and mitral valve replacement, with low rates of valve-related complications and mortality. Further long-term follow-up is recommended for these cardiac surgery devices.

Area of Science:

  • Cardiovascular Surgery
  • Biomedical Engineering
  • Prosthetic Heart Valves

Background:

  • Study evaluated 342 patients undergoing aortic valve replacement (AVR) or mitral valve replacement (MVR) with the ATS Medical prosthesis between 1997-2001.
  • Initial phase conducted under FDA investigational device exemption.
  • Objective was to determine valve-related event incidence and patient-reported noise disturbance up to five years post-implantation.

Purpose of the Study:

  • Assess the safety and efficacy of the ATS Medical prosthesis in AVR and MVR procedures.
  • Determine the incidence of valve-related complications, including mortality, thromboembolism, bleeding, and reoperation.
  • Evaluate patient experience regarding prosthetic valve noise.

Main Methods:

  • Consecutive enrollment of patients undergoing AVR or MVR with the ATS prosthesis.
  • Follow-up conducted via patient questionnaires and telephone calls, achieving 96% completeness.
  • Data collected over 878 patient-years, with specific follow-up for AVR (613 pt-yr) and MVR (265 pt-yr) groups.

Main Results:

  • Overall operative mortality was 2.6% (AVR 3.2%, MVR 1.0%), with 0.6% valve-related deaths.
  • Late valve-related complications included major bleeding (1.8%/pt-yr for AVR, 2.3%/pt-yr for MVR), neuroembolic events (0.7%/pt-yr for AVR, 0.4%/pt-yr for MVR), and paravalvular leaks.
  • Reoperation was required in 0.2%/pt-yr for AVR (paravalvular leak) and 0.4%/pt-yr for MVR (thrombosis).

Conclusions:

  • Intermediate-term outcomes with the ATS mechanical prosthesis in AVR and MVR are excellent.
  • Low rates of operative mortality and valve-related complications were observed.
  • Further long-term follow-up is necessary to fully assess the durability and safety of the prosthesis.
Abstract

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