At 1 year, the Navitor transcatheter heart valve (THV) demonstrated a low adverse event rate and excellent hemodynamics in high- and extreme-surgical-risk patients, according to data from the PORTICO NG study presented Tuesday. Dave Smith, MD, of Morriston Hospital and the University of Swansea, Wales, presented these findings at EuroPCR 2022 in Paris. PORTICO NG was a prospective, multicenter, global investigational study evaluating the safety and efficacy of the Navitor THV (Abbott) in high- or extreme-surgical-risk patients with symptomatic severe aortic stenosis. The valve is designed with a new fabric material (inner cuff), has a curved aortic stent cell design that optimizes radial force and most specifically has an active outer fabric cuff to reduce the risk of paravalvular leak (PVL). The study enrolled 120 subjects from 19 sites across Europe, Australia and the United States. The follow-ups were conducted at discharge and 30 days, and annual follow-up is ongoing through 5 years. The primary endpoint was all-cause mortality and moderate or greater PVL at 30 days. The descriptive endpoints were Valve Academic Research Consortium (VARC)-2 clinical events at 30 days, valve hemodynamic and PVL at discharge and 30 days and change in New York Heart Association (NYHA) and six-minute walk distance (6MWD) from baseline to 30 days. The baseline characteristics of the patients included a mean age of 83.5 years, 58.3% were female, and their average Society of Thoracic Surgeons (STS) risk score of 4.0%. The common comorbidities were coronary artery disease (61.7%), arrhythmias (55.8%), diabetes (27.5%) and chronic lung disease (27.5%). Extreme-risk patients comprised 18.3% of the cohort, and about 83.3% of patients had more than one frailty factor. The average procedure time was 72.8 minutes, and nearly all patients underwent transfemoral access (99.2%). Pre-implant balloon valvuloplasty (BAV) was performed in 92.5% of patients and post-implant BAV was done in 32.5%. The implanted valve sizes were 29 mm (30.8%), 27 mm (35.0%), 25 mm (30.8%) and 23 mm (3.3%). The procedural success rate was 97.5%, with no procedural deaths or conversion to surgical aortic valve replacement. Around 2.5% of patients needed a second valve due to malposition of the first device or movement upon post-dilation. The primary endpoint of all-cause mortality was 0% at 30 days and 4.2% at 1 year. The rates of disabling stroke (0.8%), acute kidney injury (1.7%), and major vascular complications (0.8%) were the same at 30 days and 1 year. Life-threatening bleeding was noted in 2.5% of patients at 30 days and 5.0% at 1 year. The new pacemaker implant rate was 15.0% at 30 days and 16.8% at 1 year. The rates of mild PVL were 17.9% at discharge, 20.3% at 30 days and 28.8% at 1 year. Only 1.0% were noted to have moderate PVL at 1 year, and no patient was noted to have severe PVL. At 1 year, 97.2% of patients remained in New York Heart Association (NYHA) class I or II, compared to 56.7% being NYHA class III or IV at baseline. The valve demonstrated excellent hemodynamics through 1 year, with a large effective orifice area (1.9 cm2) and single-digit mean gradient (7.5 mm Hg). Smith concluded that the Navitor THV is a safe option for patients with symptomatic severe aortic stenosis who are at high or extreme surgical risk. In response to questions from EuroPCR panelists, Smith added that to achieve a mild PVL rate of 20% in high- or extreme-risk patients with heavy calcification is “not bad, to be honest,” and is a testament to the sealing attributes of the valve’s NaviSeal design. The study was funded by Abbott.