Valvular & structural heart disease
Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG Study
Authors' conclusion
The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system.
Study context
- Population
- Symptomatic severe AS at high or extreme surgical riskCE mark cohort
- Participants
- 120 participants
- Outcome
- All-cause mortality and moderate or greater PVL
- Follow-up
- 30 days
Methodological detailsmulticentre, global, independent clinical events committee and echocardiographic core laboratory, Follow-up at 30 days, 1 year, and annually up to 5 years
- Multicentre
- Global
- Independent clinical events committee and echocardiographic core laboratory
- Follow-up at 30 days, 1 year, and annually up to 5 years
Main finding
As reported in the abstract
All-cause mortality
0%
Moderate or greater paravalvular leak (PVL) (no subjects)
0
Observational data: associations, not effects.
Further findings
Procedural success
- Procedural success
- 97.5%
All-cause mortality · up to 1 year
- All-cause mortality
- 4.2%
Moderate PVL · up to 1 year
- Moderate PVL
- 1.0%
Haemodynamic performance · sustained up to 1 year
- Mean gradient (mmHg)
- 7.5±3.2
- Effective orifice area (cm²)
- 1.9±0.4
Safety
VARC-2 events · 30 days
- Disabling stroke
- 0.8%
- Life-threatening bleeding
- 2.5%
- Stage 3 AKI
- 0%
- Major vascular complications
- 0.8%
- New pacemaker implantation
- 15.0%
Disabling stroke · up to 1 year
- Disabling stroke
- 0.8%
Original publication
Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG Study. EuroIntervention. Published 19 June 2023. doi:10.
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