Freestyle valve experience: technical considerations and mid-term results.

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Devices

Background:

• Stentless porcine aortic valves exhibit superior hemodynamics compared to stented valves.
• The Medtronic Freestyle valve is a stentless porcine aortic valve prosthesis.
• This study reviews the surgical techniques and clinical outcomes of the Medtronic Freestyle valve.

Purpose of the Study:

• To describe the operative techniques for the Medtronic Freestyle valve implantation.
• To review the 5-year clinical experience with the Medtronic Freestyle valve.
• To evaluate the hemodynamic performance and safety of the Medtronic Freestyle valve.

Main Methods:

• Implantation of the Medtronic Freestyle valve in 95 patients (mean age 76 years) between January 1993 and November 1997.
• Clinical assessment and Doppler echocardiography at 6 months, 1 year, and annually thereafter.
• Review of operative and late outcomes, including mortality, morbidity, and valve function.

Main Results:

• Excellent hemodynamic performance with decreased systolic gradients and increased effective orifice areas post-implantation.
• Low incidence of complications: 3 operative deaths, 10 late deaths (2 cardiac, 8 noncardiac), 3 strokes, 4 transient ischemic attacks, and 4 cases of bacteremia.
• No patient required reoperation for valve-related problems over the 5-year follow-up period.
• 91% of patients had no or trace aortic insufficiency at discharge, with no increase over time.

Conclusions:

• The Medtronic Freestyle stentless valve demonstrates excellent hemodynamics and favorable clinical results.
• The valve is associated with a low rate of complications and no need for reoperation in a 5-year follow-up.
• This study supports the use of the Medtronic Freestyle valve in aortic valve replacement procedures.