Navitor valve patients had a permanent pacemaker implantation rate of 17.6%, significantly higher than 6.7% in Evolut patients (adjusted OR 3.07; P = 0.03).
Does transcatheter aortic valve replacement with the Navitor valve increase 30-day permanent pacemaker implantation rates compared to the Evolut valve?
The Navitor TAVR system is associated with a higher overall 30-day permanent pacemaker implantation rate compared to the Evolut system, though rates are comparable in patients with small annuli and can be mitigated by higher implantation depth.
Tasa de eventos absoluta: 0% vs 0%
Background Transcatheter aortic valve replacement using self‐expandable valves requires permanent pacemaker implantation (PPI) more often compared with balloon‐expandable systems. The Navitor prosthesis is a novel, tubular‐shaped self‐expandable valve with increasing use. Methods Thirty‐day PPI rates were compared between 148 patients treated with the Navitor system and 165 patients treated with the Evolut system. Patients with preexisting PPI, high‐risk ECG (right bundle‐branch block), and Navitor 35‐mm/Evolut 34‐mm prostheses were excluded. Multivariable logistic regression was used to adjust for baseline differences. Results Patients treated with Navitor were older (83.0 IQR, 78–86 versus 81.0 IQR, 76–84 years; P < 0.01) and had higher Society of Thoracic Surgeons mortality risk (5.6% IQR, 3.0%–9.9% versus 4.3% IQR, 2.5%–7.0%; P = 0.04). Overall, PPI occurred more frequently with Navitor (17.6%) than with Evolut (6.7%; P < 0.01), and this difference persisted after adjustment (adjusted odds ratio, 3.07 95% CI, 1.10–8.40; P = 0.03; adjusted probability, 17.7% 95% CI, 15.1%–20.2% versus 6.7% 95% CI, 5.5%–7.9%). In patients with small annuli (<430 mm 2 ), unadjusted PPI rate (9.1% versus 6.4%; P = 0.55) and adjusted probabilities were similar (7.8% 95% CI, 5.0%–10.6% versus 6.4% 95% CI, 4.8%–8.0%; interaction P = 0.03). Within the Navitor cohort, PPI was more frequent with 27/29 mm than with 23/25 mm prostheses (22.3% versus 6.7%; P =0.02). Implantation depth was greater in Navitor patients requiring PPI (5.3±1.8 versus 4.3±2.2 mm; P =0.04) and lower PPI rates (2.9% versus 30.8%; P <0.01) were observed with high target implantation depth. Conclusions Depending on prosthesis size, transcatheter aortic valve replacement with the Navitor system may have PPI rates comparable to other self‐expandable valves. High implantation of the Navitor may be attempted to reduce PPI rates.
Paukovitsch et al. (Fri,) reported a other. Navitor valve patients had a permanent pacemaker implantation rate of 17.6%, significantly higher than 6.7% in Evolut patients (adjusted OR 3.07; P = 0.03).