High implantation of the SAPIEN 3 valve (≥2 mm) was associated with a lower rate of permanent pacemaker implantation compared to low implantation (4.7% vs 32%; OR 0.1; 95% CI 0.03-0.37; P<0.001).
Observational (n=131)
Does a higher implantation technique reduce the need for permanent pacemaker implantation in patients undergoing TAVI with the SAPIEN 3 valve?
High implantation of the SAPIEN 3 transcatheter heart valve (≥2 mm over the annulus plane) significantly reduces the risk of periprocedural permanent pacemaker implantation to under 5%.
Odds Ratio: 0.1 (95% CI 0.03–0.37)
Absolute Event Rate: 4.7% vs 32%
p-value: p=< 0.001
AIM: The transcatheter aortic valve SAPIEN 3 aims at reducing paravalvular leakage (PVL). The new design with outer sealing cuff may increase the risk of permanent pacemaker implantation (PPM). The aim of our study was to evaluate the optimal implantation height of the SAPIEN 3. METHODS AND RESULTS: We analysed the correlation between the implantation height of the valve and the need for PPM in 131 patients. The PPM rate for the entire group after TAVI was 18% (n = 24). In patients with a marker distance <2 mm ("low implantation"), the PPM rate was 32%, whereas in patients with a distance ≥2 mm ("high implantation"), the rate was only 4.7% (OR of 0.1 (0.03-0.37, P < 0.001)). CONCLUSION: The risk of periprocedural PPM with the Edwards SAPIEN 3 depends on implantation height; it is increased when using conventional implantation techniques. This risk can be minimized below 5% PPM by choosing a higher implantation technique with the central marker 2 mm or more over the annulus plane.
Schwerg et al. (2016) conducted an observational in Transcatheter aortic valve implantation (TAVI) (n=131). High implantation (marker distance ≥2 mm) vs. Low implantation (marker distance <2 mm) was evaluated on Permanent pacemaker implantation (PPM) (OR 0.1, 95% CI 0.03-0.37, p=< 0.001). High implantation of the SAPIEN 3 valve (≥2 mm) was associated with a lower rate of permanent pacemaker implantation compared to low implantation (4.7% vs 32%; OR 0.1; 95% CI 0.03-0.37; P<0.001).