Outcomes with a latest generation self-expandable, intra-annular, re-sheathable transcatheter heart valve System: analysis of patients with impaired left ventricular function and determinants for pacemaker implantation
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Outcomes with a latest generation self-expandable, intra-annular, re-sheathable transcatheter heart valve System: analysis of patients with impaired left ventricular function and determinants for pacemaker implantation. / Schaefer, Andreas; Neumann, Niklas; Linder, Matthias; Schofer, Niklas; Schneeberger, Yvonne; Deuschl, Florian; Schoen, Gerhard; Blankenberg, Stefan; Reichenspurner, Hermann; Conradi, Lenard; Schäfer, Ulrich.
in: CLIN RES CARDIOL, Jahrgang 107, Nr. 10, 10.2018, S. 914-923.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Outcomes with a latest generation self-expandable, intra-annular, re-sheathable transcatheter heart valve System: analysis of patients with impaired left ventricular function and determinants for pacemaker implantation
AU - Schaefer, Andreas
AU - Neumann, Niklas
AU - Linder, Matthias
AU - Schofer, Niklas
AU - Schneeberger, Yvonne
AU - Deuschl, Florian
AU - Schoen, Gerhard
AU - Blankenberg, Stefan
AU - Reichenspurner, Hermann
AU - Conradi, Lenard
AU - Schäfer, Ulrich
PY - 2018/10
Y1 - 2018/10
N2 - OBJECTIVES: We herein report a single-center experience with the Portico TAVI system. Main focus was set on outcomes in patients with impaired left ventricular (LV) function and predictors for permanent pacemaker (PPM) implantation.METHODS: Between 05/2014 and 10/2017, 106 consecutive patients received TAVI using the Portico device. For comparison of patients with/without impaired LV function, and determination of multi-slice computed tomography and electrocardiogram correlates for PPM implantation subgroups were built (Subgroup I: LVEF ≥ 50%, n = 69, Subgroup II: LVEF < 50%, n = 37; Subgroup A: no PPM implantation, n = 89; Subgroup B: PPM implantation, n = 17). Data were retrospectively analyzed.RESULTS: Device success was 95.3% (101/106) with resulting transvalvular peak/mean pressure gradients of 10.6 ± 5.6/5.4 ± 3.1 and PVL ≥ moderate in 5/106 patients (4.7%). 30-day mortality was 4.7% (5/106; subgroup I 3/69, 4.3%; subgroup II 2/37, 5.4%; p = 1.0). Regarding VARC-2 adjudicated clinical endpoints stroke (3/106, 2.8%; subgroups I/II: 2/69 vs. 1/37, p = 1.0) and acute kidney injury (9/106, 8.5%; subgroups I/II: 6/69 vs. 3/37, p = 1.0), no significant differences were found. Postprocedural PPM implantation occurred in 17.9% (19/106) of the patients. Logistic regression for PPM implantation demonstrated predictive character of left coronary cusp (LCC) calcium load in zone 1 (annular plane to coronary ostia) (p = 0.05, threshold 193 mm3) and total calcium load of zone 1 (p = 0.05, threshold 751.2 mm3).CONCLUSIONS: The Portico valve demonstrates a satisfying safety outcome, especially for patients with impaired LV function. Results of the CE-mark trial were confirmed, except for higher PPM rates. PPM rates are in accordance with other reports on this TAVI platform.
AB - OBJECTIVES: We herein report a single-center experience with the Portico TAVI system. Main focus was set on outcomes in patients with impaired left ventricular (LV) function and predictors for permanent pacemaker (PPM) implantation.METHODS: Between 05/2014 and 10/2017, 106 consecutive patients received TAVI using the Portico device. For comparison of patients with/without impaired LV function, and determination of multi-slice computed tomography and electrocardiogram correlates for PPM implantation subgroups were built (Subgroup I: LVEF ≥ 50%, n = 69, Subgroup II: LVEF < 50%, n = 37; Subgroup A: no PPM implantation, n = 89; Subgroup B: PPM implantation, n = 17). Data were retrospectively analyzed.RESULTS: Device success was 95.3% (101/106) with resulting transvalvular peak/mean pressure gradients of 10.6 ± 5.6/5.4 ± 3.1 and PVL ≥ moderate in 5/106 patients (4.7%). 30-day mortality was 4.7% (5/106; subgroup I 3/69, 4.3%; subgroup II 2/37, 5.4%; p = 1.0). Regarding VARC-2 adjudicated clinical endpoints stroke (3/106, 2.8%; subgroups I/II: 2/69 vs. 1/37, p = 1.0) and acute kidney injury (9/106, 8.5%; subgroups I/II: 6/69 vs. 3/37, p = 1.0), no significant differences were found. Postprocedural PPM implantation occurred in 17.9% (19/106) of the patients. Logistic regression for PPM implantation demonstrated predictive character of left coronary cusp (LCC) calcium load in zone 1 (annular plane to coronary ostia) (p = 0.05, threshold 193 mm3) and total calcium load of zone 1 (p = 0.05, threshold 751.2 mm3).CONCLUSIONS: The Portico valve demonstrates a satisfying safety outcome, especially for patients with impaired LV function. Results of the CE-mark trial were confirmed, except for higher PPM rates. PPM rates are in accordance with other reports on this TAVI platform.
KW - Journal Article
U2 - 10.1007/s00392-018-1263-x
DO - 10.1007/s00392-018-1263-x
M3 - SCORING: Journal article
C2 - 29705866
VL - 107
SP - 914
EP - 923
JO - CLIN RES CARDIOL
JF - CLIN RES CARDIOL
SN - 1861-0684
IS - 10
ER -
