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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

Clinical Research in Cardiology volume 107, pages 914–923 (2018)Cite this article

Abstract

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.

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Abbreviations

AS:

Aortic valve stenosis

AVB:

Atrioventricular block

BE:

Balloon-expandable

EOA:

Effective orifice area

LBBB:

Left bundle branch block

LV:

Left ventricular

LVEF:

Left ventricular ejection fraction

MSCT:

Multi-slice computed tomography

PPM:

Permanent pacemaker

PVL:

Paravalvular leakage

RBBB:

Right bundle branch block

ROC:

Receiver operating characteristic

SE:

Self-expandable

TAVI:

Transcatheter aortic valve implantation

TEE:

Transesophageal echocardiography

TF:

Transfemoral

THV:

Transcatheter heart valve

TTE:

Transthoracic echocardiography

VARC:

Valve Academic Research Consortium

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Authors and Affiliations

  1. Department of Cardiovascular Surgery, University Heart Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany

    Andreas Schaefer, Niklas Neumann, Matthias Linder, Yvonne Schneeberger, Hermann Reichenspurner & Lenard Conradi

  2. Department of General and Interventional Cardiology, University Heart Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany

    Niklas Schofer, Florian Deuschl, Stefan Blankenberg & Ulrich Schäfer

  3. Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany

    Gerhard Schoen

Authors
  1. Andreas Schaefer
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  2. Niklas Neumann
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  3. Matthias Linder
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  4. Niklas Schofer
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  5. Yvonne Schneeberger
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  8. Stefan Blankenberg
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  10. Lenard Conradi
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  11. Ulrich Schäfer
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Corresponding author

Correspondence to Andreas Schaefer.

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Conflict of interest

U. Schäfer is a consultant to Abbott vascular and St Jude Medical has received speakers honoraria, travel support, and study grants. In addition, he serves as a Proctor for Portico implantations. All other authors have nothing to disclose.

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Schaefer, A., Neumann, N., Linder, M. et al. 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. Clin Res Cardiol 107, 914–923 (2018). https://doi.org/10.1007/s00392-018-1263-x

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  • DOI: https://doi.org/10.1007/s00392-018-1263-x

Keywords

  • Transcatheter valve therapy
  • Valve disease
  • TAVI
  • TAVR
  • Self-expandable