Background To assess clinical outcomes of transcatheter aortic valve implantation comparing Medtronic CoreValve ReValving System® with Edwards SAPIEN XT.
Methods All consecutive patients in our center with aortic stenosis treated with transfemoral Medtronic CoreValve ReValving System® (MCV) from November 2009 to September 2011 (learning curve patients excluded) or Edwards SAPIEN XT (ESV) from April 2010 to September 2011 when the device became available were included.
Results In total, there were 192 patients in this analysis. The overall mean age was 79.4±8.1 years, logistic EuroSCORE 21.1±15.9% and STS-PROM score 8.8±8.6%. The MCV group consisted of a greater proportion of males (60.3% vs 43.7%; p=0.026) with a corresponding larger aortic annulus size (24.7±2.0 vs 23.4±1.7; p<0.001). The median clinical follow-up length was 171 (IQR 54–357) days. 30-day all cause mortality was 4.0%, myocardial infarction rate 1.0% and stroke 0.5%, with no differences between valve types. Life-threatening bleeding occurred in 14.7% and 11.5% had a major vascular complication. There were no differences in the combined safety endpoint at 30 days (ESV 72.2% vs MCV 71.9%; p=0.936). However, there was a significantly higher rate of device success among the ESV group (98.3% vs 90.4%; p=0.012) with additionally a significantly higher rate of conduction disturbances/arrhythmia (31.5% vs 16.0%; p=0.011) as well as pacemaker implantation (28.8% vs 5.0%; p<0.001) with MCV compared with ESV.
Conclusions In our single center experience, transcatheter aortic valve implantation was a relatively safe and effective procedure utilising both commercially available devices. However, there was an increased incidence of arrhythmia and pacemaker implantation in the MCV group.
- Transcatheter aortic valve implantation
- aortic stenosis