Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice : one-yearresults of the ACURATE neo2 PMCF Study
(2024) In EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20(1). p.85-94- Abstract
BACKGROUND: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation. AIMS: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting. METHODS: Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography).... (More)
BACKGROUND: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation. AIMS: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting. METHODS: Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography). RESULTS: The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL). CONCLUSIONS: The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248).
(Less)
- author
- organization
- publishing date
- 2024
- type
- Contribution to journal
- publication status
- published
- subject
- in
- EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
- volume
- 20
- issue
- 1
- pages
- 10 pages
- publisher
- Société Europa Edition
- external identifiers
-
- pmid:37982152
- scopus:85181539269
- ISSN
- 1969-6213
- DOI
- 10.4244/EIJ-D-23-00823
- language
- English
- LU publication?
- yes
- id
- 0a13ded5-c075-48dd-8857-816e5753e913
- date added to LUP
- 2024-02-06 13:58:07
- date last changed
- 2024-04-22 21:02:10
@article{0a13ded5-c075-48dd-8857-816e5753e913,
abstract = {{<p>BACKGROUND: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation. AIMS: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting. METHODS: Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography). RESULTS: The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL). CONCLUSIONS: The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248).</p>}},
author = {{Kim, Won Keun and Möllmann, Helge and Montorfano, Matteo and Ellert-Gregersen, Julia and Rudolph, Tanja K. and Van Mieghem, Nicolas M. and Hilker, Michael and Amat-Santos, Ignacio and Terkelsen, Christian Juhl and Petronio, Anna Sonia and Stella, Pieter and Götberg, Matthias and Rück, Andreas and Kasel, A. Markus and Trillo, Ramiro and Appleby, Clare and Barbanti, Marco and Blanke, Philipp and Asch, Federico M. and Modolo, Rodrigo and Allocco, Dominic J. and Tamburino, Corrado}},
issn = {{1969-6213}},
language = {{eng}},
number = {{1}},
pages = {{85--94}},
publisher = {{Société Europa Edition}},
series = {{EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology}},
title = {{Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice : one-yearresults of the ACURATE neo2 PMCF Study}},
url = {{http://dx.doi.org/10.4244/EIJ-D-23-00823}},
doi = {{10.4244/EIJ-D-23-00823}},
volume = {{20}},
year = {{2024}},
}