Figura 1. Nuevo dispositivo de liberación FlexNav de válvula Portico (A, B y C) y dismin...

Figura 2.  Área Valvular y gradiente medio de Portico con el nuevo dispositivo de implanta...

Figura 3.  Leak perivalvular con el nuevo dispositivo de implantación FlexNav. No se obser...

Figura 4.  Resultados a 30 días de la Hemodinamia pos implante válvula NAVITOR. Ausencia ...

Tabla 1. 

Tabla 2.  Essential results.

The report by Drs. Fernández-Pereira and associates (1) is an excellent demonstration of what a team of dedicated interventionists can achieve using the Portico valve in the first 40 patients. The success rate, complications of the procedure and results at 15.8 +/- 9.5 months are similar or better than previously published for patients at high risk of surgery or inoperable, see Tables 2 and 3 of the aforementioned article (1). The authors benefited from previous experiences with other implanted valves and previous experience with the Portico valve in other countries and adopted the latest suggestions for a successful implant and optimal results; in this way they were able to overcome some of the learning curve problems observed for most medical devices.

The Portico valve was first used clinically in 2012 (2), and the first 102 patients were published by Monaharan et al in 2016 (3). Since then, several small Registers have been published as shown in Table 1 and correspond to references 2-8.
And more recently a large European registry was published, Portico I (7) and the international randomized clinical trial of Portico vs Sapien/Evolut presented by the Congress of Transcatheter Valve Therapeutics in 2020 and published in the Lancet the same year (9) showing no inferiority to the Sapien and Evolut valves approved by the United States and even greater effective area in the Portico valve compared to the Evolut.
Lately a new release system for the Portico valve was developed, and markedly improved results were published, with greater procedure success, less need for pacemaker, less periprotesic leak and in general better results (10). Figures 1 A, B and C describe the new valve release system showing lower incidence of vascular complications determined by the lower profile of the FlexNav (1D) release device and better valve implantation with minimal moderate of periprotesic leak (Figures 2 and 3).
More recently, the latest version of the Portico valve, the NAVITOR valve was brought to clinical use and received approval for clinical use in the European Community (CE Mark). This valve has several modifications: an external sleeve designed to avoid perivalvular "leak", a thinner inner sleeve, inward bending of the upper struts and greater radial force, without increasing the delivery profile (14F and 15 F for smaller and larger valves). The results were presented at EuroPCR 2021 by Søndergaard (11) and are described in Table 2 and Figure 4.
Essentially as we see they had no severe grade valve insufficiency after implantation and vascular complications were only 1.2%.
Finally, Abbott has developed a larger Navitor valve, called Titan, that can be used on large valve rings up to 30 mm and clinical studies are underway at this time.
In summary, as the authors demonstrate in this publication (1), the Portico valve offers an optimal option for patients with severe aortic stenosis that is being considered for percutaneous implantation. The new designs of both the release system and the Portico valve will facilitate the improvement of the results of the procedure and the clinical results to 30 days and in the remote follow-up.

Augusto Pichard MD
Director Emeritus Cath Labs at Washington Hospital Center, DC.
Former Medical Director Abbott Structural Heart
Professor of Medicine, Georgetown University, Washington DC

1. Fernández-Pereira C, Mieres J, Pavlovsky H, et al. Experiencia con el implante valvular aórtico con la válvula autoexpandible Portico: resultados hospitalarios, a 30 días y en el seguimiento alejado de una serie consecutiva de pacientes. RACI 2021;12(4):212-7.

2. Manoharan G, Spence M, Rodés-Cabau J, Webb J. St Jude Medical Portico valve. EuroIntervention 2012;8:Q97-Q101.

3. Manoharan G, Linke A, Moellmann H, et al. Multicentre clinical study evaluating a novel resheathable annular functioning self-expanding transcatheter aortic valve system: safety and performance results at 30 days with the Portico system. Eurointervention 2016;12:768-74.

4. Walther T, Manoharan G, Linkec A, et al. Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the PorticoTM valve. European Journal of Cardio-Thoracic Surgery 0 (2018) 1–8 ORIGINAL ARTICLE doi:10.1093/ejcts/ezy078.

5. Perlman G, Cheung A, Dumont E, et al. Transcatheter aortic valve replacement with the Portico valve: one-year results of the early Canadian experience. EuroIntervention 2017;12:1653-9.

6. Taramasso M, Miura M, Gavazzoni M et al, The Portico transcatheter aortic valve for the treatment of severe aortic stenosis. Future Medicine Ltd. Future Cardiol (Epub ahead of print) doi: 10.2217/fca-2018-0070 C 2018.

7. Möllmann H, Linke A, Holzhey D, et al. Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family. JACC Cardio Vasc Interv 2017;10:1538-47.

8. Linke A, Holzhey D, Möllmann H, et al. Treatment of Aortic Stenosis With a SelfExpanding, ResheathableTranscatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study. CircCardiovasc Interv 2018;11:e005206.

9. Makkar R.R, Cheng W, Waksman R et al, Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised,controlled, non-inferiority trial. Lancet. 2020 Sep 5;396(10252):669-83.

10. Fontana GF, Bedogni F, Groh M, et al. Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System. J Am Coll Cardiol Intv 2020 Nov;13(21):2467-78.

11. Søndergaard L. New Improvements in Deliver System and Portico/Navitor Valve Design virtual Session PCR 2021 Paris France.

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The evolution of auto-expandable Portico valve

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