Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience

Xavier Armario; Liesbeth Rosseel; Rajesh Kharbanda; Saib Khogali; Mohamed Abdel-Wahab; Nicolas M Van Mieghem; Didier Tchétché; Nicolas Dumonteil; Ole De Backer; James Cotton; Brian McGrath; Deepu Balakrishnan; Noman Ali; Serdar Farhan; Jubin Joseph; Gaetan Charbonnier; Taishi Okuno; Fiachra McHugh; David Hildick-Smith; Nicole Gilgen; Thijmen Hokken; Mark S Spence; Christian Frerker; Marco Angelillis; Marek Grygier; James Cockburn; Henrik Bjursten; Raban V Jeger; Rui Teles; Anna S Petronio; Thomas Pilgrim; Jan-Malte Sinning; Georg Nickenig; Lars Søndergaard; Daniel J Blackman; Darren Mylotte

doi:10.1016/j.jcin.2020.09.044

Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience

Xavier Armario, Liesbeth Rosseel, Rajesh Kharbanda, Saib Khogali, Mohamed Abdel-Wahab, Nicolas M Van Mieghem, Didier Tchétché, Nicolas Dumonteil, Ole De Backer, James Cotton, Brian McGrath, Deepu Balakrishnan, Noman Ali, Serdar Farhan, Jubin Joseph, Gaetan Charbonnier, Taishi Okuno, Fiachra McHugh, David Hildick-Smith, Nicole GilgenThijmen Hokken, Mark S Spence, Christian Frerker, Marco Angelillis, Marek Grygier, James Cockburn, Henrik Bjursten, Raban V Jeger, Rui Teles, Anna S Petronio, Thomas Pilgrim, Jan-Malte Sinning, Georg Nickenig, Lars Søndergaard, Daniel J Blackman, Darren Mylotte

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6 Citationer (Scopus)

Abstract

OBJECTIVES: The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system.

BACKGROUND: The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device.

METHODS: A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported.

RESULTS: Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients.

CONCLUSIONS: Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.

Originalsprog	Engelsk
Tidsskrift	JACC: Cardiovascular Interventions
Vol/bind	14
Udgave nummer	2
Sider (fra-til)	172-181
Antal sider	10
ISSN	1936-8798
DOI	https://doi.org/10.1016/j.jcin.2020.09.044
Status	Udgivet - 25 jan. 2021

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10.1016/j.jcin.2020.09.044

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Armario, X., Rosseel, L., Kharbanda, R., Khogali, S., Abdel-Wahab, M., Van Mieghem, N. M., Tchétché, D., Dumonteil, N., De Backer, O., Cotton, J., McGrath, B., Balakrishnan, D., Ali, N., Farhan, S., Joseph, J., Charbonnier, G., Okuno, T., McHugh, F., Hildick-Smith, D., ... Mylotte, D. (2021). Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience. JACC: Cardiovascular Interventions, 14(2), 172-181. https://doi.org/10.1016/j.jcin.2020.09.044

Armario, X, Rosseel, L, Kharbanda, R, Khogali, S, Abdel-Wahab, M, Van Mieghem, NM, Tchétché, D, Dumonteil, N, De Backer, O, Cotton, J, McGrath, B, Balakrishnan, D, Ali, N, Farhan, S, Joseph, J, Charbonnier, G, Okuno, T, McHugh, F, Hildick-Smith, D, Gilgen, N, Hokken, T, Spence, MS, Frerker, C, Angelillis, M, Grygier, M, Cockburn, J, Bjursten, H, Jeger, RV, Teles, R, Petronio, AS, Pilgrim, T, Sinning, J-M, Nickenig, G, Søndergaard, L, Blackman, DJ & Mylotte, D 2021, 'Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience', JACC: Cardiovascular Interventions, bind 14, nr. 2, s. 172-181. https://doi.org/10.1016/j.jcin.2020.09.044

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title = "Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience",

abstract = "OBJECTIVES: The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system.BACKGROUND: The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device.METHODS: A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported.RESULTS: Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients.CONCLUSIONS: Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.",

keywords = "Aortic Valve Stenosis/surgery, Aortic Valve/surgery, Europe, Heart Valve Prosthesis, Humans, Prosthesis Design, Retrospective Studies, Risk Factors, Transcatheter Aortic Valve Replacement, Treatment Outcome",

author = "Xavier Armario and Liesbeth Rosseel and Rajesh Kharbanda and Saib Khogali and Mohamed Abdel-Wahab and {Van Mieghem}, {Nicolas M} and Didier Tch{\'e}tch{\'e} and Nicolas Dumonteil and {De Backer}, Ole and James Cotton and Brian McGrath and Deepu Balakrishnan and Noman Ali and Serdar Farhan and Jubin Joseph and Gaetan Charbonnier and Taishi Okuno and Fiachra McHugh and David Hildick-Smith and Nicole Gilgen and Thijmen Hokken and Spence, {Mark S} and Christian Frerker and Marco Angelillis and Marek Grygier and James Cockburn and Henrik Bjursten and Jeger, {Raban V} and Rui Teles and Petronio, {Anna S} and Thomas Pilgrim and Jan-Malte Sinning and Georg Nickenig and Lars S{\o}ndergaard and Blackman, {Daniel J} and Darren Mylotte",

year = "2021",

month = jan,

day = "25",

doi = "10.1016/j.jcin.2020.09.044",

language = "English",

volume = "14",

pages = "172--181",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc",

number = "2",

}

TY - JOUR

T1 - Transcatheter Aortic Valve Replacement With the LOTUS Edge System

T2 - Early European Experience

AU - Armario, Xavier

AU - Rosseel, Liesbeth

AU - Kharbanda, Rajesh

AU - Khogali, Saib

AU - Abdel-Wahab, Mohamed

AU - Van Mieghem, Nicolas M

AU - Tchétché, Didier

AU - Dumonteil, Nicolas

AU - De Backer, Ole

AU - Cotton, James

AU - McGrath, Brian

AU - Balakrishnan, Deepu

AU - Ali, Noman

AU - Farhan, Serdar

AU - Joseph, Jubin

AU - Charbonnier, Gaetan

AU - Okuno, Taishi

AU - McHugh, Fiachra

AU - Hildick-Smith, David

AU - Gilgen, Nicole

AU - Hokken, Thijmen

AU - Spence, Mark S

AU - Frerker, Christian

AU - Angelillis, Marco

AU - Grygier, Marek

AU - Cockburn, James

AU - Bjursten, Henrik

AU - Jeger, Raban V

AU - Teles, Rui

AU - Petronio, Anna S

AU - Pilgrim, Thomas

AU - Sinning, Jan-Malte

AU - Nickenig, Georg

AU - Søndergaard, Lars

AU - Blackman, Daniel J

AU - Mylotte, Darren

PY - 2021/1/25

Y1 - 2021/1/25

N2 - OBJECTIVES: The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system.BACKGROUND: The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device.METHODS: A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported.RESULTS: Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients.CONCLUSIONS: Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.

AB - OBJECTIVES: The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system.BACKGROUND: The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device.METHODS: A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported.RESULTS: Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2, and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients.CONCLUSIONS: Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.

KW - Aortic Valve Stenosis/surgery

KW - Aortic Valve/surgery

KW - Europe

KW - Heart Valve Prosthesis

KW - Humans

KW - Prosthesis Design

KW - Retrospective Studies

KW - Risk Factors

KW - Transcatheter Aortic Valve Replacement

KW - Treatment Outcome

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U2 - 10.1016/j.jcin.2020.09.044

DO - 10.1016/j.jcin.2020.09.044

M3 - Journal article

C2 - 33478633

SN - 1936-8798

VL - 14

SP - 172

EP - 181

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 2

ER -

Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience

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