International journal of cardiology · 2026
Early outcomes of the Octapro balloon-expandable transcatheter heart valve in an unrestricted cohort of patients with aortic valve stenosis: the MyPro registry.
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Ielasi Alfonso, Moscarella Elisabetta, Verček Gregor, Frerker Christian, Testa Luca, Ijsselmuiden Alexander, Maisano Francesco, Secco Gioel Gabrio, Cigala Emanuele, Tchetche Didier, Gunasekaran Sengottuvelu, Micari Antonio, Gennari Marco, Calabrò Paolo, Di Lorenzo Emilio, Chandra Praveen, Seth Ashok, Eitel Ingo, Bunc Matjaž
Аннотация
BACKGROUND: Data on early outcomes of the novel balloon-expandable (BE) Octapro transcatheter heart valve (THV) in real-world practice are limited. We sought to assess procedural safety and early outcomes of the Octapro in patients with severe native aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI).
METHODS: Between November 2024 and October 2025, consecutive patients with severe AS undergoing TAVI with Octapro in European and Indian centres were enrolled. Primary endpoints were VARC-3 technical success, device success, and early safety at 30-day.
RESULTS: A total of 303 patients were included (age 78.9 ± 7.4 years; bicuspid 13%). VARC-3 technical success was 97%, peri-procedural mortality 0.3% while no procedural stroke or myocardial infarction were reported. In-hospital guidelines-indicated permanent pacemaker implantation (PPI) rate was 13.5%. At discharge mean gradient was 8.4 ± 4.5 mmHg, effective orifice area 1.8 ± 0.3 cm2, while moderate-to-severe paravalvular leak was reported in 3.3% of the patients. At 30-day, device success was 92.4% and early safety 80%. All-cause mortality was 2.6%, stroke 0.3%, and guidelines-indicated PPI 14.2%. Mean gradient remained low (9 ± 4 mmHg). Implantation depth and baseline right bundle branch block (RBBB) were independent predictors of PPI. ROC analysis identified an implantation depth threshold of 4.75 mm associated with increased PPI risk.
CONCLUSIONS: In this real-world registry, the Octapro THV demonstrated high procedural success, favourable early clinical outcomes, and excellent haemodynamic performance. Implantation depth and baseline RBBB were independent predictors of PPI, supporting optimization of implantation technique to mitigate conduction disturbances.
METHODS: Between November 2024 and October 2025, consecutive patients with severe AS undergoing TAVI with Octapro in European and Indian centres were enrolled. Primary endpoints were VARC-3 technical success, device success, and early safety at 30-day.
RESULTS: A total of 303 patients were included (age 78.9 ± 7.4 years; bicuspid 13%). VARC-3 technical success was 97%, peri-procedural mortality 0.3% while no procedural stroke or myocardial infarction were reported. In-hospital guidelines-indicated permanent pacemaker implantation (PPI) rate was 13.5%. At discharge mean gradient was 8.4 ± 4.5 mmHg, effective orifice area 1.8 ± 0.3 cm2, while moderate-to-severe paravalvular leak was reported in 3.3% of the patients. At 30-day, device success was 92.4% and early safety 80%. All-cause mortality was 2.6%, stroke 0.3%, and guidelines-indicated PPI 14.2%. Mean gradient remained low (9 ± 4 mmHg). Implantation depth and baseline right bundle branch block (RBBB) were independent predictors of PPI. ROC analysis identified an implantation depth threshold of 4.75 mm associated with increased PPI risk.
CONCLUSIONS: In this real-world registry, the Octapro THV demonstrated high procedural success, favourable early clinical outcomes, and excellent haemodynamic performance. Implantation depth and baseline RBBB were independent predictors of PPI, supporting optimization of implantation technique to mitigate conduction disturbances.