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Periprocedural and Short-Term Outcomes of Transfemoral Transcatheter Aortic Valve Implantation With the Sapien XT as Compared With the Edwards Sapien Valve
Study Questions:
What are the short-term outcomes after transcatheter aortic valve implantation (TAVI) with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, CA)?
Methods:
All consecutive patients (n = 120) who underwent TAVI in the author’s center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54) were analyzed. Valve Academic Research Consortium endpoints were used. Exploratory multivariable analysis was performed to assess the predictors of major vascular events (MVEs) by means of logistic regression analysis with purposeful selection of covariates and simultaneous entry. Candidate variables included covariates associated at univariate analysis with MVE (all with a p value < 0.1). The results are reported as adjusted odds ratios (ORs) with associated confidence intervals (CIs).
Results:
Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were threefold lower in the SXT group (11.1% vs. 33.3%; relative risk [RR], 0.40; 95% confidence interval [CI], 0.28-0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; RR, 0.44; 95% CI, 0.24-0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild to moderate in 70.2% of SXT and 76.3% of ESV.
Conclusions:
The authors concluded that the new SXT valve has the same short-term performance as the ESV, but seems to be associated with a lower risk of major vascular complications.
Perspective:
This study suggests that transfemoral TAVI with both the SXT and ESV was associated with a high device success rate and relatively low periprocedural and short-term outcomes in high-risk elderly patients, and the SXT valve seems to have the same short-term performance as the ESV. Furthermore, the requirement for a smaller ilio-femoral diameter and lower risk of major vascular complications extended the clinical applications of the SXT valve system and may have a broader clinical application.
Keywords: Heart Valve Prosthesis Implantation
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