Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Feb 12:27:100480.
doi: 10.1016/j.ijcha.2020.100480. eCollection 2020 Apr.

Transcatheter treatment of native aortic valve regurgitation: Results from an international registry using the transfemoral ACURATE neo valve

Paola Angela Maria Purita  1 , Luisa Salido Tahoces  2 , Chiara Fraccaro  3 , Luca Nai Fovino  3 , Won-Keun Kim  4 , Cláudio Espada-Guerreiro  5 , Ole De Backer  6 , Morritz Seiffert  7 , Luis Nombela-Franco  8 , Raul Moreno Gomez  9 , Antonio Mangieri  10 , Anna Franzone  11 , Francesco Bedogni  12 , Fausto Castriota  13 , Tiziana Attisano  14 , Lars Søndergaard  6 , Rosana Hernandez Antolin  2 , Giuseppe Tarantini  3
Affiliations

Transcatheter treatment of native aortic valve regurgitation: Results from an international registry using the transfemoral ACURATE neo valve

Paola Angela Maria Purita et al. Int J Cardiol Heart Vasc. .

Abstract

Background: Transcatheter aortic valve replacement (TAVR) has been validated for the treatment of severe symptomatic aortic stenosis in patients at high and intermediate surgical risk. Recently, TAVR has been proposed as an alternative to medical therapy in inoperable patients with severe native aortic valve regurgitation (NAVR). This multicenter international registry sought to evaluate safety and efficacy of TAVR with the self-expandable ACURATE neo valve in a cohort of patients with NAVR.

Methods: A total of 24 patients with severe NAVR treated by TAVR between September 2016 and October 2018 in 13 European centers were included. Clinical, procedural and follow up data were inserted in a dedicated database. Outcomes were codified according to Valve Academic Research Consortium-2 criteria.

Results: Mean age was 79.4 years, 58.4% were female. Mean EuroSCORE II and STS score were 5% and 3.9%, respectively. Device success was 87.5%. Moderate paravalvular leak (PVL) was found in two (8.3%) of patients, both with a perimeter oversizing index <10%. Implantation of a second device was necessary in three cases (12.5%), one for severe PVL and two for device displacement. New pacemaker implantation rate was 21.1%. At 30 days, stroke and all-cause mortality rates were 0% and 4.1%, respectively.

Conclusions: This multicenter study suggests good feasibility and early safety of transfemoral TAVR with the self-expandable ACURATE neo device in patients with severe NAVR refused for surgery. Rates of moderate PVL, new pacemaker implantation and need for a second valve were higher than those reported for TAVR in aortic stenosis.

Keywords: AR, aortic regurgitation; AS, aortic stenosis; Acurate Neo; CHF, congestive heart failure; NAVR, native aortic valve regurgitation; NYHA, New York Heart Association; Native aortic valve regurgitation; PVL, paravalvular leak; TAVR, transcatheter aortic valve replacement; THV, transcatheter heart valve; Transcatheter aortic valve replacement; VARC 2, Valve Academic Research Consortium 2.

PubMed Disclaimer

Conflict of interest statement

Ole de Backer: consultant for Abbott; Won-Keun Kim: received proctor fees from Symetis SA/Boston Scientific, St. Jude Medical/Abbott, lecture honoraria from Edwards Lifesciences, Symetis SA/Boston, St. Jude Medical/Abbott; Luis Nombela-Franco received proctor fees from Abbott, lecture honoraria from Edwards Lifesciences and Boston Scientific; Moritz Seiffert received lecture honorary or congress travel support from Abbott, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic and Symetis. Fausto Castriota received proctor fes from Boston Scientific. Dr. Bedogni has served as a consultant for Abbott Vascular, Medtronic, Boston Scientific, and Terumo. Lars Sondergaard: received research grants and has been consultant for Abbott, Medtronic and Boston Scientific. Giuseppe Tarantini: proctor for Boston Scientific and received lecture fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Fig. 1
Fig. 1
(A) The Accurate neo transfemoral prosthesis (from bostonscientifics.com). (B) Sequential angiographic images of the proximal end of stent holder into the left ventricular outflow tract by 5–7 mm (a), opening of the upper crown and stabilization arches (b), valve release (c).
Fig. 2
Fig. 2
(A) Change in aortic regurgitation from baseline to post-procedure up to 30-day follow up. (B) Rates of device success, post-procedural moderate aortic regurgitation, implantation of a second valve and new pacemaker implantation according to perimeter oversizing. AR = aortic regurgitation (includes both paravalvular leak and prosthetic valvular regurgitation).
See this image and copyright information in PMC

References

    1. Baumgartner H., Falk V., Bax J.J., De Bonis M., Hamm C., Holm P.J. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur. Heart J. 2017;38:2739–2791. - PubMed
    1. Mack M.J., Leon M.B., Thourani V.H., Makkar R., Kodali S.K., Russo M. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N. Engl. J. Med. 2019;380:1695–1705. - PubMed
    1. Ueshima D., Fovino L.N., D'Amico G., Brener S.J., Esposito G., Tarantini G. Transcatheter versus surgical aortic valve replacement in low- and intermediate-risk patients: an updated systematic review and meta-analysis. Cardiovasc. Interv. Ther. 2019;34:216–225. - PubMed
    1. Tarantini G., Nai Fovino L., D'Errigo P., Rosato S., Barbanti M., Tamburino C. Factors influencing the choice between transcatheter and surgical treatment of severe aortic stenosis in patients younger than 80 years: results from the OBSERVANT study. Catheter. Cardiovasc. Interv. 2019 - PubMed
    1. Cribier A. Commemorating the 15-year anniversary of TAVI: insights into the early stages of development, from concept to human application, and perspectives. EuroIntervention. 2017;13:29–37. - PubMed