• Lower Mortality and Excellent Hemodynamics with Portico Valve FlexNav Delivery and Predecessor: CONFIDENCE Registry

    The first-generation Portico delivery system (DS) and second-generation FlexNav DS demonstrated excellent clinical results in high- and extreme-surgical-risk patients, according to the findings from the large, real-world CONFIDENCE Registry.

    Helge Möllmann, MD, of St. Johannes Hospital, Dortmund, Germany, presented these results during a Late-Breaking Trial session Sunday at Transcatheter Cardiovascular Therapeutics (TCT) 2022 in Boston.

    CONFIDENCE study is a prospective, multi-center, non-randomized, study that enrolled a total of 1,001 subjects (n=501 Portico DS system and n=500 FlexNav DS) with symptomatic severe aortic stenosis from October 2018 to July 2021 across 28 centers in Europe and Australia. The primary endpoint was Valve Academic Research Consortium (VARC)-2) event rates at 30 days, and a survival status check was conducted at 1 year as a follow-up.

    The first-generation Portico DS is an 18- to 19-French system with the ability to recapture, retrieve and reposition the Portico valve (Abbott). The second-generation FlexNav DS is a 14- to 15-French system that offers an additional stability layer for accurate placement of the valve.

    Overall, the baseline characteristics were similar between the two cohorts except for the minimum vessel diameter, which was larger (7.42 mm vs 7.09 mm, p=0.0002) in the Portico DS group compared to the FlexNav DS group.

    The mean age of patients was 81.7 ± 5.4 years in Portico DS and 82.3 ± 5.3 years in FlexNav DS. The average Society of Thoracic Surgeons risk scores were comparable, 4.6% ± 3.1% Portico DS and 4.5% ± 2.6% FlexNav DS (p=0.735).

    The study demonstrated that the VARC-2 all-cause mortality rate was 3.2% in Portico DS and 2.0% in FlexNav DS (p=0.638) at 30 days and 13.7% and 11.0%, respectively, (p=0.204) at 1 year. Likewise, the rates of cardiovascular mortality were comparable, 3.0% vs 1.2% (p=0.127) at 30 days and 7.3% vs 9.4% (p=0.255) at 1 year.

    The rates of disabling stroke (1.6% vs 2.0%, p=0.599) and new pacemaker implantation (PPI) rates (19.2% vs 18.9%, p=0.977) were also similar at 30 days. The overall PPI rates varied by implant depth and were lower (12.6%) with low (2-4 mm) implantation depth in comparison to higher (>10 mm) implantation depth (31.8%). The study also demonstrated excellent hemodynamic performance at 30 days across all valve sizes with single-digit gradients and large effective orifice areas. The majority (97.9%) of patients had mild or less paravalvular leak at 30 days.

    Möllmann concluded that the Portico self-expanding, intra-annular valve, with first-generation Portico DS and second-generation FlexNav DS, delivered excellent clinical results in a large real-world study in high- and extreme-surgical-risk patients with low mortality and paravalvular leak rates.

    In answering a panelist’s question regarding the difference in mortality between two valve DS, Möllmann stated that the mortality rate was numerically improved in the second-generation FlexNav DS, but this did not reach statistical significance, as there were several deaths due to COVID-19 during the enrollment period of the second-generation FlexNav DS cohort.

    The registry is sponsored by Abbott.

    Image Credit: Jason Wermers/CRTonline.org

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