February 12, 2018Structural Heart2 citationsOpen Access
Early and Mid-Term Outcomes of Transcatheter Aortic Valve Replacement Using the New Generation Self-Expanding Corevalve Evolut R Device
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Key Result
TAVR using the Evolut R device was associated with higher device success (92.8% vs. 79.7%, P<0.001) and lower rates of moderate or severe PVR compared to a historical CoreValve cohort.
Study Design
Type
Cohort (n=320)
Multicenter
No
Structured PICO
Does TAVR with the CoreValve Evolut R device improve device success and reduce complications compared to the older CoreValve in patients requiring TAVR?
P
Population
320 consecutive patients (median age 81.1 years) undergoing transcatheter aortic valve replacement with the Evolut R device, evaluated at 30 days.
E
Exposure
Transcatheter aortic valve replacement (TAVR) using the new-generation self-expanding CoreValve Evolut R device (23-, 26-, 29-, 34-mm)
C
Comparator
Historical cohort of patients who underwent older generation CoreValve implantation (propensity score matched)
O
Outcome
Device success, hemodynamics (mean gradient, paravalvular regurgitation), and 30-day clinical outcomes (mortality, stroke, bleeding, pacemaker implantation)composite
The new-generation CoreValve Evolut R device for TAVR demonstrates high device success, excellent hemodynamics, and lower complication rates compared to the older generation CoreValve.
Main Result
Absolute Event Rate: 92.8% vs 79.7%
p-value: p=< 0.001
Limitations
- Single-center study
- Historical cohort used for comparison
Abstract
Background To assess early and mid-term efficacy of transcatheter aortic valve replacement (TAVR) using the new-generation CoreValve Evolut R (Medtronic Inc., Galway, Ireland). Methods This is a prospective, single-center study. All consecutive patients undergoing TAVR with 23-, 26-, 29-, 34-mm Evolut R valve were included. In a secondary analysis, patients undergoing Evolut R implantation were compared using the propensity score method with a historical cohort of patients who underwent CoreValve implantation in our institution. Results From March 2015 to September 2017, a total of 320 patients with a median age of 81.1 years (IQR 77–84) and mean STS score of 4.9 ± 3.1% were treated. Device success was obtained in 300 patients (93.8%). Effective recapture and repositioning of the valve due to initial suboptimal deployment was accomplished in 40 patients (12.5%). Post-TAVR transthoracic echocardiogram showed a reduction in mean gradient from 49.1 ± 18.2 mmHg to 7.6 ± 0.4 mmHg ( p < 0.001). Moderate paravalvular regurgitation (PVR) was observed in 4.2% patients. No patient had severe PVR. At 30-day, all-cause and cardiovascular mortality rates were 2.2% and 1.9%, respectively; disabling stroke occurred in 5 patients (1.6%). Life-threatening and major bleeding occurred in 16 (5.0%) and 42 (13.1%) patients, respectively. Pacemaker implantation rate was 12.6%. Compared with the CoreValve, Evolut R use was associated with higher device success (92.8% vs. 79.7%, p < 0.001) and lower rates of moderate or severe PVR (2.1% vs. 14.4%, p < 0.001), minor vascular complications (4.9% vs. 14.5%, p < 0.001), and pacemaker implantation (13.5% vs. 21.0%, p = 0.026). Conclusion In this prospective, single-center study, TAVR using the new-generation self-expanding Evolut R system, was associated with high device success rate, excellent hemodynamics, and low early complications rates.