Thursday, August 19, 2010
hart kleppen
More European Results on Transcatheter Aortic Valve Implantation
Encouraging findings from a study of short-term registry data
Treatment of aortic stenosis with transcatheter aortic valve implantation (TAVI) is becoming routine outside the U.S.; two devices are now available. These investigators report 30-day outcomes in 32 European centers participating in the manufacturer-sponsored SOURCE registry following commercial release of the SAPIEN device.
The cohort included 1038 adults (mean age, 81), 463 of whom received the device transfemorally (TF) and 575 transapically (TA). All patients were at high risk (logistic EuroSCORE, 29% with TA; 26% with TF) for complications of surgical aortic valve replacement (AVR). The procedural success rate was >90%, but important complications included valve embolization (0.3%), coronary obstruction (0.6%), and conversion to surgical AVR (2.7%). Adverse events at 30 days included death (8.5%), new need for a pacemaker (7.0%), major vascular complications (7.0%), renal failure requiring dialysis (4.3%), and stroke (2.5%). Mortality was slightly higher — and vascular complications lower — in the TA group than in the TF group; the authors attributed the increased mortality in the TA group to their higher baseline risk profile.
Comment: This early real-world experience with a TAVI device in high-risk patients with aortic stenosis demonstrates a high short-term procedural success rate and low overall 30-day mortality — and also reveals opportunities for improvement (e.g., avoidance of vascular complications, valve malposition). Data on long-term survival and comparison with surgically and medically managed patients are needed to further define the role of this new therapy.
— Howard C. Herrmann, MD
Published in Journal Watch Cardiology August 18, 2010
Encouraging findings from a study of short-term registry data
Treatment of aortic stenosis with transcatheter aortic valve implantation (TAVI) is becoming routine outside the U.S.; two devices are now available. These investigators report 30-day outcomes in 32 European centers participating in the manufacturer-sponsored SOURCE registry following commercial release of the SAPIEN device.
The cohort included 1038 adults (mean age, 81), 463 of whom received the device transfemorally (TF) and 575 transapically (TA). All patients were at high risk (logistic EuroSCORE, 29% with TA; 26% with TF) for complications of surgical aortic valve replacement (AVR). The procedural success rate was >90%, but important complications included valve embolization (0.3%), coronary obstruction (0.6%), and conversion to surgical AVR (2.7%). Adverse events at 30 days included death (8.5%), new need for a pacemaker (7.0%), major vascular complications (7.0%), renal failure requiring dialysis (4.3%), and stroke (2.5%). Mortality was slightly higher — and vascular complications lower — in the TA group than in the TF group; the authors attributed the increased mortality in the TA group to their higher baseline risk profile.
Comment: This early real-world experience with a TAVI device in high-risk patients with aortic stenosis demonstrates a high short-term procedural success rate and low overall 30-day mortality — and also reveals opportunities for improvement (e.g., avoidance of vascular complications, valve malposition). Data on long-term survival and comparison with surgically and medically managed patients are needed to further define the role of this new therapy.
— Howard C. Herrmann, MD
Published in Journal Watch Cardiology August 18, 2010
# posted by roodbont @ 9:15 AM 
