Journal of the American Heart Association · 2026
Pacemaker Implantation Rates With the Self-Expandable Navitor Valve.
СтатьяСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Paukovitsch Michael, Konjack Moritz, Felbel Dominik, Krohn-Grimberghe Marvin, Schneider Leonhard M, Mörike Johannes, Rottbauer Wolfgang, Buckert Dominik
Аннотация
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 mm2), 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.
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 mm2), 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.