Edwards Lifesciences has successfully completed the first minimal-access, beating-heart surgical procedure for replacing a patient's aortic heart valve. Edwards is planning to develop the Ascendra aortic heart valve replacement system as an additional option for valve surgery. The company plans to continue to evaluate its feasibility in European and Canadian studies in 2006.
A medical team from St Paul's Hospital in Vancouver, British Columbia, used the company's Cribier-Edwards percutaneous heart valve to perform Trans-Apical Placement (TAP), a beating-heart procedure in which a stent-mounted aortic valve is delivered through a mini-incision between the ribs. The first TAP procedure was performed at St Paul's by Drs Samuel Lichtenstein, director of cardiovascular surgery, and John Webb, director of interventional cardiology, in November 2005.
"The valve's innovative, sutureless design enabled us to perform aortic valve replacement surgery on a beating heart without cardiopulmonary bypass, offering patients an option that should reduce the recovery time and complications associated with traditional, open-heart surgery," said Lichtenstein.
While traditional aortic valve replacement surgery requires opening the patient's chest, stopping their heart and managing their circulation on cardiopulmonary bypass for at least an hour, the first TAP procedure was completed on a beating heart less than 30 minutes after the surgical mini-incision was made. So far more than 75 patients have received the Cribier-Edwards percutaneous aortic heart valve.
The TAP procedure using the Edwards Ascendra valve system was developed in partnership with surgical teams led by Drs Michael Mack of Dallas, TX, Friedrich Mohr of Leipzig, Germany and Gerhardt Wimmer-Greinecker of Frankfurt, Germany.
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