A pooled analysis of two prospective, single-arm studies demonstrates excellent safety of Portico transcatheter heart valves implanted with the low-profile FlexNav Delivery System, according to late-breaking trial results presented Friday at the PCR e-Course.
Raj R. Makkar, MD, of Cedars-Sinai Medical Center, Los Angeles, presented the results at the PCR e-Course. Gregory P. Fontana, MD, of Los Robles Regional Medical Center, Thousand Oaks, California, and colleagues, including Makkar, reported their findings in a manuscript simultaneously published online in JACC: Cardiovascular Interventions.
Transcatheter aortic valve replacement (TAVR) is a procedure done worldwide in symptomatic patients with aortic stenosis with increased surgical risk. The most common and safest route of implantation is transfemoral access; however, it is limited by size, morphology and tortuosity of the vessel. Over time delivery systems became narrower allowing for more patients to undergo the procedure transfemorally. The investigators sought to characterize the safety profile of the intra-annular, self-expanding Portico valve together with the newly designed FlexNav delivery system, which was augmented by the addition of a hydrophilic coating, a stability layer and controlled deployment.
The Portico valve is commercially available in Europe; in the U.S., it is an investigational device.
Fontana and colleagues pooled data from two ongoing, single-arm, multicenter prospective studies: The IDE FlexNav DS (U.S.) and FlexNav DS EU CE Mark Study. Valve Academic Research Consortium (VARC) 2-defined major vascular complications at 30 days was the primary outcome.
The pooled analysis included 180 patients at high or extreme surgical risk. Their mean age was 85 years, 60% were women, and they had a mean Society of Thoracic Surgeons (STS) score of 5.3%. A valve was successfully implanted with successful retrieval of the delivery system in 96.7% of cases. The remaining 3.3% of patients required a second valve because of valve malposition.
The rate of new permanent pacemaker implantation in this cohort was 15.4%, which was markedly lower than in the recent PORTICO IDE trial (28.1% in the as-treated population). The attributed the lower pacemaker rate to the FlexNav delivery system providing better control, allowing for higher and more accurate valve deployment. The rate of major vascular complications at 30 days was 4.4%, which was mainly related to the access-site. Like other available valves, moderate paravalvular leak was seen in 4.1% of cases. Finally, 30-day rates of both disabling stroke (1.1%) and death (0.6%) were low.
Although the analysis was limited by its non-randomized design, sites having different Portico experience levels, different implantation depths and lower average STS scores secondary to new STS risk calculations, the FlexNav delivery system together with the Portico valve was found to be safe at 30 days.
The IDE FlexNav DS and FlexNav DS EU CE Mark studies are sponsored by Abbott.
The PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.
Fontana GP, Bedogni F, Groh M, et al. Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System. JACC Cardiovasc Interv 2020 Jun 26. https://doi.org/10.1016/j.jcin.2020.06.041