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Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves

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Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves. / Schaefer, Andreas; Treede, Hendrik; Schoen, Gerhard; Deuschl, Florian; Schofer, Niklas; Schneeberger, Yvonne; Blankenberg, Stefan; Reichenspurner, Hermann; Schaefer, Ulrich; Conradi, Lenard.

In: EUR J CARDIO-THORAC, Vol. 50, No. 2, 08.2016, p. 368-373.

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

Harvard

Schaefer, A, Treede, H, Schoen, G, Deuschl, F, Schofer, N, Schneeberger, Y, Blankenberg, S, Reichenspurner, H, Schaefer, U & Conradi, L 2016, 'Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves', EUR J CARDIO-THORAC, vol. 50, no. 2, pp. 368-373. https://doi.org/10.1093/ejcts/ezw021

APA

Schaefer, A., Treede, H., Schoen, G., Deuschl, F., Schofer, N., Schneeberger, Y., Blankenberg, S., Reichenspurner, H., Schaefer, U., & Conradi, L. (2016). Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves. EUR J CARDIO-THORAC, 50(2), 368-373. https://doi.org/10.1093/ejcts/ezw021

Vancouver

Schaefer A, Treede H, Schoen G, Deuschl F, Schofer N, Schneeberger Y et al. Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves. EUR J CARDIO-THORAC. 2016 Aug;50(2):368-373. https://doi.org/10.1093/ejcts/ezw021

Bibtex

@article{be60645999554132bfb69a03fec067af,
title = "Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves",
abstract = "OBJECTIVES: The published literature has extensively documented clinical benefit derived from transcatheter aortic valve implantation (TAVI) in high-risk patients using self-expanding current-generation transfemoral (TF) transcatheter heart valves (THVs). However, it has also demonstrated apparent shortcomings such as paravalvular leakage (PVL) or need for permanent pacemaker (PM) implantation. We here present a case-matched analysis of acute 30-day outcomes using a novel nitinol-based THV (Symetis Acurate Neo TF{\texttrademark}), which may overcome some limitations of currently used devices.METHODS: From 2012 to 2015, 69 consecutive patients (study group, 65.2% female, 81.4 ± 6.1 years, logEuroSCORE I 19.9 ± 14.2%) received TF-TAVI using the novel Symetis Acurate Neo TF{\texttrademark} THV. A control group of patients after TF-TAVI with the CoreValve{\texttrademark} THV was retrieved from our database (control group) and matched to the study group utilizing 16 parameters. Data were retrospectively analysed according to updated Valve Academic Research Consortium (VARC-2) definitions. The 30-day follow-up was completed in all cases.RESULTS: Apart from gender (65.2 vs 44.9% females, P = 0.023), matching was successful with parameters showing no significant differences. The device success rate was 95.6% (66/69) and 89.9% (62/69) in the study and control groups, respectively (P = 0.20). The all-cause 30-day mortality rate was 5.8% (4/69) vs 10.14% (7/69) (P = 0.36), and disabling stroke was observed in 2.9% (2/69) vs 5.8% (4/69) (P = 0.41), respectively. Resultant transvalvular maximum/mean gradient and effective orifice area (EOA) were 13.8 ± 5.5 vs 18.1 ± 8.1 mmHg (P = 0.001)/7.0 ± 2.8 vs 8.8 ± 4.0 mmHg (P = 0.006) and 1.9 ± 0.3 vs 1.8 ± 0.2 cm(2) (P = 0.015), respectively. PVL ≥grade II was observed in 2.9% (2/69) and 15.94% (11/69) (P = 0.013) of patients and the rate of PM implantation was 8.7% (6/69) vs 44.9% (31/69) (P < 0.001), respectively.DISCUSSION: TF-TAVI was feasible and safe using this new type of nitinol-based THV. Superiority to the current generation of self-expanding THVs was achieved regarding post-interventional pressure gradients and EOA, severity of residual PVL and rate of PM implantation. Results set a promising quality standard for TF-TAVI with a self-expanding THV, but will have to be confirmed in a larger patient cohorts for further clinical evaluation.",
author = "Andreas Schaefer and Hendrik Treede and Gerhard Schoen and Florian Deuschl and Niklas Schofer and Yvonne Schneeberger and Stefan Blankenberg and Hermann Reichenspurner and Ulrich Schaefer and Lenard Conradi",
note = "{\textcopyright} The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.",
year = "2016",
month = aug,
doi = "10.1093/ejcts/ezw021",
language = "English",
volume = "50",
pages = "368--373",
journal = "EUR J CARDIO-THORAC",
issn = "1010-7940",
publisher = "Elsevier",
number = "2",

}

RIS

TY - JOUR

T1 - Improving outcomes: case-matched comparison of novel second-generation versus first-generation self-expandable transcatheter heart valves

AU - Schaefer, Andreas

AU - Treede, Hendrik

AU - Schoen, Gerhard

AU - Deuschl, Florian

AU - Schofer, Niklas

AU - Schneeberger, Yvonne

AU - Blankenberg, Stefan

AU - Reichenspurner, Hermann

AU - Schaefer, Ulrich

AU - Conradi, Lenard

N1 - © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

PY - 2016/8

Y1 - 2016/8

N2 - OBJECTIVES: The published literature has extensively documented clinical benefit derived from transcatheter aortic valve implantation (TAVI) in high-risk patients using self-expanding current-generation transfemoral (TF) transcatheter heart valves (THVs). However, it has also demonstrated apparent shortcomings such as paravalvular leakage (PVL) or need for permanent pacemaker (PM) implantation. We here present a case-matched analysis of acute 30-day outcomes using a novel nitinol-based THV (Symetis Acurate Neo TF™), which may overcome some limitations of currently used devices.METHODS: From 2012 to 2015, 69 consecutive patients (study group, 65.2% female, 81.4 ± 6.1 years, logEuroSCORE I 19.9 ± 14.2%) received TF-TAVI using the novel Symetis Acurate Neo TF™ THV. A control group of patients after TF-TAVI with the CoreValve™ THV was retrieved from our database (control group) and matched to the study group utilizing 16 parameters. Data were retrospectively analysed according to updated Valve Academic Research Consortium (VARC-2) definitions. The 30-day follow-up was completed in all cases.RESULTS: Apart from gender (65.2 vs 44.9% females, P = 0.023), matching was successful with parameters showing no significant differences. The device success rate was 95.6% (66/69) and 89.9% (62/69) in the study and control groups, respectively (P = 0.20). The all-cause 30-day mortality rate was 5.8% (4/69) vs 10.14% (7/69) (P = 0.36), and disabling stroke was observed in 2.9% (2/69) vs 5.8% (4/69) (P = 0.41), respectively. Resultant transvalvular maximum/mean gradient and effective orifice area (EOA) were 13.8 ± 5.5 vs 18.1 ± 8.1 mmHg (P = 0.001)/7.0 ± 2.8 vs 8.8 ± 4.0 mmHg (P = 0.006) and 1.9 ± 0.3 vs 1.8 ± 0.2 cm(2) (P = 0.015), respectively. PVL ≥grade II was observed in 2.9% (2/69) and 15.94% (11/69) (P = 0.013) of patients and the rate of PM implantation was 8.7% (6/69) vs 44.9% (31/69) (P < 0.001), respectively.DISCUSSION: TF-TAVI was feasible and safe using this new type of nitinol-based THV. Superiority to the current generation of self-expanding THVs was achieved regarding post-interventional pressure gradients and EOA, severity of residual PVL and rate of PM implantation. Results set a promising quality standard for TF-TAVI with a self-expanding THV, but will have to be confirmed in a larger patient cohorts for further clinical evaluation.

AB - OBJECTIVES: The published literature has extensively documented clinical benefit derived from transcatheter aortic valve implantation (TAVI) in high-risk patients using self-expanding current-generation transfemoral (TF) transcatheter heart valves (THVs). However, it has also demonstrated apparent shortcomings such as paravalvular leakage (PVL) or need for permanent pacemaker (PM) implantation. We here present a case-matched analysis of acute 30-day outcomes using a novel nitinol-based THV (Symetis Acurate Neo TF™), which may overcome some limitations of currently used devices.METHODS: From 2012 to 2015, 69 consecutive patients (study group, 65.2% female, 81.4 ± 6.1 years, logEuroSCORE I 19.9 ± 14.2%) received TF-TAVI using the novel Symetis Acurate Neo TF™ THV. A control group of patients after TF-TAVI with the CoreValve™ THV was retrieved from our database (control group) and matched to the study group utilizing 16 parameters. Data were retrospectively analysed according to updated Valve Academic Research Consortium (VARC-2) definitions. The 30-day follow-up was completed in all cases.RESULTS: Apart from gender (65.2 vs 44.9% females, P = 0.023), matching was successful with parameters showing no significant differences. The device success rate was 95.6% (66/69) and 89.9% (62/69) in the study and control groups, respectively (P = 0.20). The all-cause 30-day mortality rate was 5.8% (4/69) vs 10.14% (7/69) (P = 0.36), and disabling stroke was observed in 2.9% (2/69) vs 5.8% (4/69) (P = 0.41), respectively. Resultant transvalvular maximum/mean gradient and effective orifice area (EOA) were 13.8 ± 5.5 vs 18.1 ± 8.1 mmHg (P = 0.001)/7.0 ± 2.8 vs 8.8 ± 4.0 mmHg (P = 0.006) and 1.9 ± 0.3 vs 1.8 ± 0.2 cm(2) (P = 0.015), respectively. PVL ≥grade II was observed in 2.9% (2/69) and 15.94% (11/69) (P = 0.013) of patients and the rate of PM implantation was 8.7% (6/69) vs 44.9% (31/69) (P < 0.001), respectively.DISCUSSION: TF-TAVI was feasible and safe using this new type of nitinol-based THV. Superiority to the current generation of self-expanding THVs was achieved regarding post-interventional pressure gradients and EOA, severity of residual PVL and rate of PM implantation. Results set a promising quality standard for TF-TAVI with a self-expanding THV, but will have to be confirmed in a larger patient cohorts for further clinical evaluation.

U2 - 10.1093/ejcts/ezw021

DO - 10.1093/ejcts/ezw021

M3 - SCORING: Journal article

C2 - 26888463

VL - 50

SP - 368

EP - 373

JO - EUR J CARDIO-THORAC

JF - EUR J CARDIO-THORAC

SN - 1010-7940

IS - 2

ER -