Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison

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Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison. / Mauri, Victor; Kim, Won K; Abumayyaleh, Mohammad; Walther, Thomas; Moellmann, Helge; Schaefer, Ulrich; Conradi, Lenard; Hengstenberg, Christian; Hilker, Michael; Wahlers, Thorsten; Baldus, Stephan; Rudolph, Volker; Madershahian, Navid; Rudolph, Tanja K.

In: CIRC-CARDIOVASC INTE, Vol. 10, No. 10, 10.2017.

Research output: SCORING: Contribution to journalSCORING: Journal articleResearchpeer-review

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Mauri, V., Kim, W. K., Abumayyaleh, M., Walther, T., Moellmann, H., Schaefer, U., Conradi, L., Hengstenberg, C., Hilker, M., Wahlers, T., Baldus, S., Rudolph, V., Madershahian, N., & Rudolph, T. K. (2017). Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison. CIRC-CARDIOVASC INTE, 10(10). https://doi.org/10.1161/CIRCINTERVENTIONS.117.005013

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Bibtex

@article{328d1009139d4137bb5a94d9a3215d44,
title = "Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison",
abstract = "BACKGROUND: Surgical aortic valve replacement in patients with small annular dimensions is challenging because they are at increased risk for prosthesis-patient mismatch and impaired outcomes. Transcatheter aortic valve replacement might be a good alternative; however, comparative data on different transcatheter heart valves are missing.METHODS AND RESULTS: This multicenter, propensity score-matched study compared hemodynamics and early clinical outcomes in 246 patients with an aortic annulus area <400 mm2 undergoing transcatheter aortic valve replacement with either a self-expanding transcatheter heart valve (Symetis ACURATE neo, n=129) or a balloon-expandable transcatheter heart valve (Edwards SAPIEN 3, n=117). The 1:1 propensity score matching resulted in 92 matched pairs. For ACURATE neo versus SAPIEN 3-treated patients, 30-day mortality (0.0% versus 1.0%), 1-year mortality (8.3% versus 13.3%), incidence of stroke (3.3% versus 2.2%), life-threatening bleeding (1.1% versus 1.1%), and major vascular complications (2.2% versus 6.5%), as well as pacemaker implantation rate (12.0% versus 15.2%), were similar. Paravalvular regurgitation ≥moderate was rare in both groups (4.5% versus 3.6%). The ACURATE neo presented lower mean transvalvular gradients (9.3 versus 14.5 mm Hg; P<0.001), larger indexed effective orifice areas (0.96 versus 0.80 cm2/m2; P=0.003), and lower rates of severe prosthesis-patient mismatch (3% versus 22%; P=0.004). Hemodynamics were sustained at 1-year follow-up.CONCLUSIONS: Albeit a similar safety profile with low clinical event rates, transcatheter aortic valve replacement with the ACURATE neo valve resulted in lower transvalvular gradients and consequently less prosthesis-patient mismatch compared with the SAPIEN 3 in patients with small annulus. These results emphasize the need of careful prosthesis selection in each individual patient.",
keywords = "Aged, Aged, 80 and over, Aortic Valve, Female, Heart Valve Prosthesis/adverse effects, Hemodynamics, Humans, Male, Propensity Score, Transcatheter Aortic Valve Replacement/adverse effects",
author = "Victor Mauri and Kim, {Won K} and Mohammad Abumayyaleh and Thomas Walther and Helge Moellmann and Ulrich Schaefer and Lenard Conradi and Christian Hengstenberg and Michael Hilker and Thorsten Wahlers and Stephan Baldus and Volker Rudolph and Navid Madershahian and Rudolph, {Tanja K}",
note = "{\textcopyright} 2017 American Heart Association, Inc.",
year = "2017",
month = oct,
doi = "10.1161/CIRCINTERVENTIONS.117.005013",
language = "English",
volume = "10",
journal = "CIRC-CARDIOVASC INTE",
issn = "1941-7640",
publisher = "Lippincott Williams and Wilkins",
number = "10",

}

RIS

TY - JOUR

T1 - Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison

AU - Mauri, Victor

AU - Kim, Won K

AU - Abumayyaleh, Mohammad

AU - Walther, Thomas

AU - Moellmann, Helge

AU - Schaefer, Ulrich

AU - Conradi, Lenard

AU - Hengstenberg, Christian

AU - Hilker, Michael

AU - Wahlers, Thorsten

AU - Baldus, Stephan

AU - Rudolph, Volker

AU - Madershahian, Navid

AU - Rudolph, Tanja K

N1 - © 2017 American Heart Association, Inc.

PY - 2017/10

Y1 - 2017/10

N2 - BACKGROUND: Surgical aortic valve replacement in patients with small annular dimensions is challenging because they are at increased risk for prosthesis-patient mismatch and impaired outcomes. Transcatheter aortic valve replacement might be a good alternative; however, comparative data on different transcatheter heart valves are missing.METHODS AND RESULTS: This multicenter, propensity score-matched study compared hemodynamics and early clinical outcomes in 246 patients with an aortic annulus area <400 mm2 undergoing transcatheter aortic valve replacement with either a self-expanding transcatheter heart valve (Symetis ACURATE neo, n=129) or a balloon-expandable transcatheter heart valve (Edwards SAPIEN 3, n=117). The 1:1 propensity score matching resulted in 92 matched pairs. For ACURATE neo versus SAPIEN 3-treated patients, 30-day mortality (0.0% versus 1.0%), 1-year mortality (8.3% versus 13.3%), incidence of stroke (3.3% versus 2.2%), life-threatening bleeding (1.1% versus 1.1%), and major vascular complications (2.2% versus 6.5%), as well as pacemaker implantation rate (12.0% versus 15.2%), were similar. Paravalvular regurgitation ≥moderate was rare in both groups (4.5% versus 3.6%). The ACURATE neo presented lower mean transvalvular gradients (9.3 versus 14.5 mm Hg; P<0.001), larger indexed effective orifice areas (0.96 versus 0.80 cm2/m2; P=0.003), and lower rates of severe prosthesis-patient mismatch (3% versus 22%; P=0.004). Hemodynamics were sustained at 1-year follow-up.CONCLUSIONS: Albeit a similar safety profile with low clinical event rates, transcatheter aortic valve replacement with the ACURATE neo valve resulted in lower transvalvular gradients and consequently less prosthesis-patient mismatch compared with the SAPIEN 3 in patients with small annulus. These results emphasize the need of careful prosthesis selection in each individual patient.

AB - BACKGROUND: Surgical aortic valve replacement in patients with small annular dimensions is challenging because they are at increased risk for prosthesis-patient mismatch and impaired outcomes. Transcatheter aortic valve replacement might be a good alternative; however, comparative data on different transcatheter heart valves are missing.METHODS AND RESULTS: This multicenter, propensity score-matched study compared hemodynamics and early clinical outcomes in 246 patients with an aortic annulus area <400 mm2 undergoing transcatheter aortic valve replacement with either a self-expanding transcatheter heart valve (Symetis ACURATE neo, n=129) or a balloon-expandable transcatheter heart valve (Edwards SAPIEN 3, n=117). The 1:1 propensity score matching resulted in 92 matched pairs. For ACURATE neo versus SAPIEN 3-treated patients, 30-day mortality (0.0% versus 1.0%), 1-year mortality (8.3% versus 13.3%), incidence of stroke (3.3% versus 2.2%), life-threatening bleeding (1.1% versus 1.1%), and major vascular complications (2.2% versus 6.5%), as well as pacemaker implantation rate (12.0% versus 15.2%), were similar. Paravalvular regurgitation ≥moderate was rare in both groups (4.5% versus 3.6%). The ACURATE neo presented lower mean transvalvular gradients (9.3 versus 14.5 mm Hg; P<0.001), larger indexed effective orifice areas (0.96 versus 0.80 cm2/m2; P=0.003), and lower rates of severe prosthesis-patient mismatch (3% versus 22%; P=0.004). Hemodynamics were sustained at 1-year follow-up.CONCLUSIONS: Albeit a similar safety profile with low clinical event rates, transcatheter aortic valve replacement with the ACURATE neo valve resulted in lower transvalvular gradients and consequently less prosthesis-patient mismatch compared with the SAPIEN 3 in patients with small annulus. These results emphasize the need of careful prosthesis selection in each individual patient.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve

KW - Female

KW - Heart Valve Prosthesis/adverse effects

KW - Hemodynamics

KW - Humans

KW - Male

KW - Propensity Score

KW - Transcatheter Aortic Valve Replacement/adverse effects

U2 - 10.1161/CIRCINTERVENTIONS.117.005013

DO - 10.1161/CIRCINTERVENTIONS.117.005013

M3 - SCORING: Journal article

C2 - 28951395

VL - 10

JO - CIRC-CARDIOVASC INTE

JF - CIRC-CARDIOVASC INTE

SN - 1941-7640

IS - 10

ER -