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News

Mid-term performance data on CryoLife’s CryoValve SG human heart valve is released

CryoLife : 01 July, 2008  (Company News)
Positive mid-term performance data has been released on CryoLife’s CryoValve SG decellularised pulmonary human heart valve at the 34th Annual Western Thoracic Surgical Association Meeting in Kona, Hawaii, USA.
The data was presented by John W Brown, MD, professor of cardiothoracic surgery, Indiana University School of Medicine.

For the study, 342 patients who received a CryoValve SG processed using CryoLife's proprietary SynerGraft technology were compared to 1,246 patients who received a conventionally processed CryoValve pulmonary heart valve. All patients received the valves in conjunction with either a right ventricular outflow tract (RVOT) reconstruction or as part of the Ross Procedure, which is described below.

Average follow-up time was 3.9 years for the CryoValve SG RVOT procedure patients, and 4.7 years for the Ross Procedure patients. The average follow-up times were comparable for patients who received the conventionally processed CryoValve.

The results showed that there was a statistically significant reduction in structural valve deterioration - SVD (71 percent actuarial freedom from SVD at five years for CryoValve SG versus 55 percent for CryoValve) and valvular insufficiency (48 percent of patients with trivial or less valvular insufficiency at last follow-up for CryoValve SG versus 30 percent for CryoValve) in patients who received the CryoValve SG for RVOT reconstruction as compared to the conventionally processed valve.

Valvular insufficiency occurs when the valve leaflets do not completely seal when the valve is closed, causing regurgitation, or the backward flow of blood into the heart chamber.

The data also indicated that there was a statistically significant reduction in valvular insufficiency in patients who received the CryoValve SG as part of the Ross Procedure as compared to the conventionally processed valve (67 percent of patients with trivial or less valvular insufficiency at last follow-up for CryoValve SG versus 51 percent for CryoValve).

For all other measured mid-term clinical endpoints there was no statistical difference between the CryoValve SG and the CryoValve recipients, including actuarial freedom from SVD at five years in patients undergoing Ross procedures (79 percent for CryoValve SG versus 78 percent for CryoValve), and for all patient groups there was no statistical difference between recipient groups for actuarial freedom from valve related death or explant at five years (Ross patients: 97 percent for CryoValve SG versus 95 percent for CryoValve; RVOT patients: 93 percent for CryoValve SG versus 89 percent for CryoValve), actuarial freedom from endocarditis at five years (Ross patients: 100 percent for CryoValve SG versus 99 percent for CryoValve; RVOT patients: 98 percent for CryoValve SG versus 100 percent for CryoValve) or actuarial freedom from cardiac reoperation at five years (Ross patients: 95 percent for CryoValve SG versus 95 percent for CryoValve; RVOT patients: 93 percent for CryoValve SG versus 90 percent for CryoValve), and transvalvular gradients or pressure change across the valve at last follow-up (Average Peak Gradient in Ross patients: 19.0 millimetres of Mercury for CryoValve SG versus 21.8 millimetres of Mercury for CryoValve; RVOT patients: 22.9 millimetres of Mercury for CryoValve SG versus 22.2 millimetres of Mercury for CryoValve).
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