Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study

Won-Keun Kim; Helge Möllmann; Matteo Montorfano; Julia Ellert-Gregersen; Tanja K Rudolph; Nicolas M Van Mieghem; Michael Hilker; Ignacio Amat-Santos; Christian Juhl Terkelsen; Anna Sonia Petronio; Pieter Stella; Matthias Götberg; Andreas Rück; A Markus Kasel; Ramiro Trillo; Clare Appleby; Marco Barbanti; Philipp Blanke; Federico M Asch; Rodrigo Modolo; Dominic J Allocco; Corrado Tamburino

doi:10.4244/EIJ-D-23-00823

Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study

Won-Keun Kim, Helge Möllmann, Matteo Montorfano, Julia Ellert-Gregersen, Tanja K Rudolph, Nicolas M Van Mieghem, Michael Hilker, Ignacio Amat-Santos, Christian Juhl Terkelsen, Anna Sonia Petronio, Pieter Stella, Matthias Götberg, Andreas Rück, A Markus Kasel, Ramiro Trillo, Clare Appleby, Marco Barbanti, Philipp Blanke, Federico M Asch, Rodrigo ModoloDominic J Allocco, Corrado Tamburino

Institut for Klinisk Medicin - Hjertesygdomme

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

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). 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).

Originalsprog	Engelsk
Tidsskrift	EuroIntervention
Vol/bind	20
Nummer	1
Sider (fra-til)	85-94
Antal sider	10
ISSN	1774-024X
DOI	https://doi.org/10.4244/EIJ-D-23-00823
Status	Udgivet - jan. 2024

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10.4244/EIJ-D-23-00823

Citationsformater

Kim, W.-K., Möllmann, H., Montorfano, M., Ellert-Gregersen, J., Rudolph, T. K., Van Mieghem, N. M., Hilker, M., Amat-Santos, I., Terkelsen, C. J., Petronio, A. S., Stella, P., Götberg, M., Rück, A., Kasel, A. M., Trillo, R., Appleby, C., Barbanti, M., Blanke, P., Asch, F. M., ... Tamburino, C. (2024). Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study. EuroIntervention, 20(1), 85-94. https://doi.org/10.4244/EIJ-D-23-00823

@article{353575e5111e4c1da34cd34d5e53d309,

title = "Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study",

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). 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).",

author = "Won-Keun Kim and Helge M{\"o}llmann and Matteo Montorfano and Julia Ellert-Gregersen and Rudolph, {Tanja K} and {Van Mieghem}, {Nicolas M} and Michael Hilker and Ignacio Amat-Santos and Terkelsen, {Christian Juhl} and Petronio, {Anna Sonia} and Pieter Stella and Matthias G{\"o}tberg and Andreas R{\"u}ck and Kasel, {A Markus} and Ramiro Trillo and Clare Appleby and Marco Barbanti and Philipp Blanke and Asch, {Federico M} and Rodrigo Modolo and Allocco, {Dominic J} and Corrado Tamburino",

year = "2024",

month = jan,

doi = "10.4244/EIJ-D-23-00823",

language = "English",

volume = "20",

pages = "85--94",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "Europa Digital & Publishing",

number = "1",

}

Kim, W-K, Möllmann, H, Montorfano, M, Ellert-Gregersen, J, Rudolph, TK, Van Mieghem, NM, Hilker, M, Amat-Santos, I, Terkelsen, CJ, Petronio, AS, Stella, P, Götberg, M, Rück, A, Kasel, AM, Trillo, R, Appleby, C, Barbanti, M, Blanke, P, Asch, FM, Modolo, R, Allocco, DJ & Tamburino, C 2024, 'Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study', EuroIntervention, bind 20, nr. 1, s. 85-94. https://doi.org/10.4244/EIJ-D-23-00823

Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study. / Kim, Won-Keun; Möllmann, Helge; Montorfano, Matteo et al.
I: EuroIntervention, Bind 20, Nr. 1, 01.2024, s. 85-94.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice

T2 - one-yearresults of the ACURATE neo2 PMCF Study

AU - Kim, Won-Keun

AU - Möllmann, Helge

AU - Montorfano, Matteo

AU - Ellert-Gregersen, Julia

AU - Rudolph, Tanja K

AU - Van Mieghem, Nicolas M

AU - Hilker, Michael

AU - Amat-Santos, Ignacio

AU - Terkelsen, Christian Juhl

AU - Petronio, Anna Sonia

AU - Stella, Pieter

AU - Götberg, Matthias

AU - Rück, Andreas

AU - Kasel, A Markus

AU - Trillo, Ramiro

AU - Appleby, Clare

AU - Barbanti, Marco

AU - Blanke, Philipp

AU - Asch, Federico M

AU - Modolo, Rodrigo

AU - Allocco, Dominic J

AU - Tamburino, Corrado

PY - 2024/1

Y1 - 2024/1

N2 - 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).

AB - 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).

U2 - 10.4244/EIJ-D-23-00823

DO - 10.4244/EIJ-D-23-00823

M3 - Journal article

C2 - 37982152

SN - 1774-024X

VL - 20

SP - 85

EP - 94

JO - EuroIntervention

JF - EuroIntervention

IS - 1

ER -

Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study

Abstract

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