Key result
Among high-risk patients undergoing TAVI, permanent pacemaker implantation occurred more frequently with the Medtronic CoreValve than the Edwards SAPIEN valve (28.6% vs 4.2%; p=0.02).
Why the study?
What are the 30-day outcomes and vascular complication rates of transarterial TAVI using a mixed approach of Medtronic CoreValve and Edwards SAPIEN valves in high-risk patients with aortic stenosis?
Observational (n=45)
What are the 30-day outcomes and vascular complication rates of transarterial TAVI using a mixed approach of Medtronic CoreValve and Edwards SAPIEN valves in high-risk patients with aortic stenosis?
A routine policy of using both Medtronic CoreValve and Edwards SAPIEN valves for transarterial TAVI is feasible with high procedural success and acceptable 30-day outcomes in high-risk patients.
Answers are grounded in this paper and cite their sources.
Early mixed-valve TAVI experience shows high procedural success; leaves open durability and comparative effectiveness questions.
AIMS: Transcatheter aortic valve implantation (TAVI) is performed through a transarterial approach with encouraging results in "one-type valve" registries. We report 30-day data from a mixed population of patients treated with either Medtronic CoreValve (MCV) or Edwards SAPIEN (ES) valves. METHODS AND RESULTS: Forty-five patients had TAVI via the transarterial approach (21 MCV and 24 ES). Mean age was 81.8+/-4.2 years, Logistic EuroSCORE was 25.2+/-8.4%. Procedural success rate was 97.8%. In-hospital death rate was 4.4%. Vascular complication rate was 8.9%. Of MCV patients, 28.6% had a permanent pacemaker vs. 4.2% of ES patients; p=0.02. No additional deaths were observed between discharge and 30 days. NYHA functional class was improved at 30-days: 2.07+/-0.4 vs. 3.09+/-0.05, p<0.0001. Mean transvalvular gradient was lower: 9.5+/-3.28 mmHg vs. 41.9+/-14 mmHg, p<0.0001. Overall 30-day MACE rate was 8.9%, similar between MCV and ES patients. CONCLUSION: A routine policy of TAVI using both MCV and ES valves is feasible without any worsening of procedural success rates and 30-day outcomes. A wider population of high risk patients with aortic stenosis can be offered a transarterial treatment. This could be the next standard of care for teams performing TAVI.
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Tchétché et al. (2010) conducted an observational in Aortic stenosis (n=45). Medtronic CoreValve (MCV) vs. Edwards SAPIEN (ES) was evaluated on Permanent pacemaker implantation (p=0.02). Among high-risk patients undergoing TAVI, permanent pacemaker implantation occurred more frequently with the Medtronic CoreValve than the Edwards SAPIEN valve (28.6% vs 4.2%; p=0.02).
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