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, Jahrgang 10, Nr. 10, 10.2017.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -