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

N1 - Funding Information: Dr. Khogali is a proctor for Medtronic and Boston Scientific. Dr. Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and is a consultant for Abbott Vascular, Boston Scientific, PulseCath BV, Medtronic, and Daiichi-Sankyo. Dr. Cotton is a proctor for Boston Scientific; and has received speaker fees from Abbott Vascular and Medtronic. Dr. Frerker has received lecture honoraria and travel support from Boston Scientific, Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr. Grygier is a consultant and proctor for Boston Scientific and Medtronic; and has received consulting fees and institutional research grants from Abbott Vascular, Boston Scientific, and Medtronic. Dr. Bjursten is a consultant and proctor for Boston Scientific; and has received institutional research grants from Boston Scientific. Dr. Jeger has received speaker honoraria and research support from B. Braun; and has received speaker honoraria from Cardionovum. Dr. Teles has received consulting fees and institutional research grants from Medtronic, Boston Scientific, and Abbott Vascular. Dr. Petronio is a consultant for Medtronic, Boston Scientific, and Abbott Vascular. Dr. Pilgrim has received research grants to the institution from Boston Scientific, Biotronik, and Edwards Lifesciences; has received speaker fees from Boston Scientific and Biotronik; and is a consultant for HighLife SAS. Dr. Søndergaard has received consulting fees and institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. Mylotte is a consultant for Medtronic, Boston Scientific, and Microport. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: © 2021 American College of Cardiology Foundation

PY - 2021

Y1 - 2021

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

KW - transcatheter aortic valve replacement

KW - transcatheter heart valve

U2 - 10.1016/j.jcin.2020.09.044

DO - 10.1016/j.jcin.2020.09.044

M3 - Journal article

C2 - 33478633

AN - SCOPUS:85098939377

VL - 14

SP - 172

EP - 181

JO - J A C C: Cardiovascular Interventions

JF - J A C C: Cardiovascular Interventions

SN - 1936-8798

IS - 2

ER -