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Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions

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Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions. / Schaefer, Andreas; Linder, Matthias; Treede, Hendrik; Deuschl, Florian; Schofer, Niklas; Seiffert, Moritz; Schneeberger, Yvonne; Blankenberg, Stefan; Reichenspurner, Hermann; Schaefer, Ulrich; Conradi, Lenard.

In: CLIN RES CARDIOL, Vol. 105, No. 7, 07.2016, p. 585-91.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Schaefer, A, Linder, M, Treede, H, Deuschl, F, Schofer, N, Seiffert, M, Schneeberger, Y, Blankenberg, S, Reichenspurner, H, Schaefer, U & Conradi, L 2016, 'Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions', CLIN RES CARDIOL, vol. 105, no. 7, pp. 585-91. https://doi.org/10.1007/s00392-015-0954-9

APA

Schaefer, A., Linder, M., Treede, H., Deuschl, F., Schofer, N., Seiffert, M., Schneeberger, Y., Blankenberg, S., Reichenspurner, H., Schaefer, U., & Conradi, L. (2016). Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions. CLIN RES CARDIOL, 105(7), 585-91. https://doi.org/10.1007/s00392-015-0954-9

Vancouver

Schaefer A, Linder M, Treede H, Deuschl F, Schofer N, Seiffert M et al. Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions. CLIN RES CARDIOL. 2016 Jul;105(7):585-91. https://doi.org/10.1007/s00392-015-0954-9

Bibtex

@article{45d4c217ea4f4f20be56c62639747904,
title = "Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions",
abstract = "OBJECTIVES: Physicians are frequently confronted with patients suffering from aortic stenosis with annular diameters exceeding dimensions in which currently available transcatheter heart valves (THV) are formally approved. Experience in patients receiving significantly undersized Sapien 3 (S3) THV (Edwards Lifesciences, Inc., Irvine, CA, USA) in aortic annuli up to 32 mm has not been reported so far.METHODS: Patients with aortic annuli exceeding the formally determined upper size limit and who received a 29 mm S3, were identified from our database. Calcification pattern and annulus dimension were analyzed retrospectively using the 3mensio Medical Imaging software. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-2 definitions.RESULTS: 21 consecutive patients with aortic annuli ≥28.1 mm received a 29 mm THV. All patients were male (77.4 ± 8.1 year, logEuroSCORE I 22.5 ± 14.1 %). Multi-slice computed tomography and transesophageal echocardiography derived annular dimensions were 30.2 ± 1.5 vs. 28.8 ± 0.9 mm (p = 0.0001). Total calcium load of the aortic valves was 1327 ± 957 mm(3). Device success according to VARC-2 definitions was achieved in 100 % (21/21). All-cause 30-day mortality was 0 % (0/21). Rate of permanent pacemaker implantation was 14.3 % (3/21). No paravalvular leakage ≥ grade II was detectable.CONCLUSIONS: Preliminary experience suggests implantation of this type of THV in aortic annuli up to 32 mm to be feasible and safe, in particular calcification patterns. It does not result in a relevant incidence of PVL ≥ grade II, or increased rate of VARC-2 adjudicated clinical endpoints. Also, functional outcomes regarding transvalvular gradients or EOA demonstrate applicability of this THV in such patients.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/diagnostic imaging, Aortic Valve Insufficiency/etiology, Aortic Valve Stenosis/diagnostic imaging, Arrhythmias, Cardiac/etiology, Balloon Valvuloplasty/adverse effects, Calcinosis/diagnostic imaging, Cardiac Catheterization/adverse effects, Cardiac Pacing, Artificial, Databases, Factual, Echocardiography, Transesophageal, Feasibility Studies, Female, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation/adverse effects, Humans, Imaging, Three-Dimensional, Male, Multidetector Computed Tomography, Pacemaker, Artificial, Predictive Value of Tests, Prosthesis Design, Radiographic Image Interpretation, Computer-Assisted, Retrospective Studies, Time Factors, Treatment Outcome",
author = "Andreas Schaefer and Matthias Linder and Hendrik Treede and Florian Deuschl and Niklas Schofer and Moritz Seiffert and Yvonne Schneeberger and Stefan Blankenberg and Hermann Reichenspurner and Ulrich Schaefer and Lenard Conradi",
year = "2016",
month = jul,
doi = "10.1007/s00392-015-0954-9",
language = "English",
volume = "105",
pages = "585--91",
journal = "CLIN RES CARDIOL",
issn = "1861-0684",
publisher = "D. Steinkopff-Verlag",
number = "7",

}

RIS

TY - JOUR

T1 - Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions

AU - Schaefer, Andreas

AU - Linder, Matthias

AU - Treede, Hendrik

AU - Deuschl, Florian

AU - Schofer, Niklas

AU - Seiffert, Moritz

AU - Schneeberger, Yvonne

AU - Blankenberg, Stefan

AU - Reichenspurner, Hermann

AU - Schaefer, Ulrich

AU - Conradi, Lenard

PY - 2016/7

Y1 - 2016/7

N2 - OBJECTIVES: Physicians are frequently confronted with patients suffering from aortic stenosis with annular diameters exceeding dimensions in which currently available transcatheter heart valves (THV) are formally approved. Experience in patients receiving significantly undersized Sapien 3 (S3) THV (Edwards Lifesciences, Inc., Irvine, CA, USA) in aortic annuli up to 32 mm has not been reported so far.METHODS: Patients with aortic annuli exceeding the formally determined upper size limit and who received a 29 mm S3, were identified from our database. Calcification pattern and annulus dimension were analyzed retrospectively using the 3mensio Medical Imaging software. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-2 definitions.RESULTS: 21 consecutive patients with aortic annuli ≥28.1 mm received a 29 mm THV. All patients were male (77.4 ± 8.1 year, logEuroSCORE I 22.5 ± 14.1 %). Multi-slice computed tomography and transesophageal echocardiography derived annular dimensions were 30.2 ± 1.5 vs. 28.8 ± 0.9 mm (p = 0.0001). Total calcium load of the aortic valves was 1327 ± 957 mm(3). Device success according to VARC-2 definitions was achieved in 100 % (21/21). All-cause 30-day mortality was 0 % (0/21). Rate of permanent pacemaker implantation was 14.3 % (3/21). No paravalvular leakage ≥ grade II was detectable.CONCLUSIONS: Preliminary experience suggests implantation of this type of THV in aortic annuli up to 32 mm to be feasible and safe, in particular calcification patterns. It does not result in a relevant incidence of PVL ≥ grade II, or increased rate of VARC-2 adjudicated clinical endpoints. Also, functional outcomes regarding transvalvular gradients or EOA demonstrate applicability of this THV in such patients.

AB - OBJECTIVES: Physicians are frequently confronted with patients suffering from aortic stenosis with annular diameters exceeding dimensions in which currently available transcatheter heart valves (THV) are formally approved. Experience in patients receiving significantly undersized Sapien 3 (S3) THV (Edwards Lifesciences, Inc., Irvine, CA, USA) in aortic annuli up to 32 mm has not been reported so far.METHODS: Patients with aortic annuli exceeding the formally determined upper size limit and who received a 29 mm S3, were identified from our database. Calcification pattern and annulus dimension were analyzed retrospectively using the 3mensio Medical Imaging software. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-2 definitions.RESULTS: 21 consecutive patients with aortic annuli ≥28.1 mm received a 29 mm THV. All patients were male (77.4 ± 8.1 year, logEuroSCORE I 22.5 ± 14.1 %). Multi-slice computed tomography and transesophageal echocardiography derived annular dimensions were 30.2 ± 1.5 vs. 28.8 ± 0.9 mm (p = 0.0001). Total calcium load of the aortic valves was 1327 ± 957 mm(3). Device success according to VARC-2 definitions was achieved in 100 % (21/21). All-cause 30-day mortality was 0 % (0/21). Rate of permanent pacemaker implantation was 14.3 % (3/21). No paravalvular leakage ≥ grade II was detectable.CONCLUSIONS: Preliminary experience suggests implantation of this type of THV in aortic annuli up to 32 mm to be feasible and safe, in particular calcification patterns. It does not result in a relevant incidence of PVL ≥ grade II, or increased rate of VARC-2 adjudicated clinical endpoints. Also, functional outcomes regarding transvalvular gradients or EOA demonstrate applicability of this THV in such patients.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Insufficiency/etiology

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Arrhythmias, Cardiac/etiology

KW - Balloon Valvuloplasty/adverse effects

KW - Calcinosis/diagnostic imaging

KW - Cardiac Catheterization/adverse effects

KW - Cardiac Pacing, Artificial

KW - Databases, Factual

KW - Echocardiography, Transesophageal

KW - Feasibility Studies

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Humans

KW - Imaging, Three-Dimensional

KW - Male

KW - Multidetector Computed Tomography

KW - Pacemaker, Artificial

KW - Predictive Value of Tests

KW - Prosthesis Design

KW - Radiographic Image Interpretation, Computer-Assisted

KW - Retrospective Studies

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1007/s00392-015-0954-9

DO - 10.1007/s00392-015-0954-9

M3 - SCORING: Journal article

C2 - 26680213

VL - 105

SP - 585

EP - 591

JO - CLIN RES CARDIOL

JF - CLIN RES CARDIOL

SN - 1861-0684

IS - 7

ER -