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Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions

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Abstract

Objectives

Physicians are frequently confronted with patients suffering from aortic stenosis with annular diameters exceeding dimensions in which currently available transcatheter heart valves (THV) are formally approved. Experience in patients receiving significantly undersized Sapien 3 (S3) THV (Edwards Lifesciences, Inc., Irvine, CA, USA) in aortic annuli up to 32 mm has not been reported so far.

Methods

Patients with aortic annuli exceeding the formally determined upper size limit and who received a 29 mm S3, were identified from our database. Calcification pattern and annulus dimension were analyzed retrospectively using the 3mensio Medical Imaging software. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-2 definitions.

Results

21 consecutive patients with aortic annuli ≥28.1 mm received a 29 mm THV. All patients were male (77.4 ± 8.1 year, logEuroSCORE I 22.5 ± 14.1 %). Multi-slice computed tomography and transesophageal echocardiography derived annular dimensions were 30.2 ± 1.5 vs. 28.8 ± 0.9 mm (p = 0.0001). Total calcium load of the aortic valves was 1327 ± 957 mm3. Device success according to VARC-2 definitions was achieved in 100 % (21/21). All-cause 30-day mortality was 0 % (0/21). Rate of permanent pacemaker implantation was 14.3 % (3/21). No paravalvular leakage ≥ grade II was detectable.

Conclusions

Preliminary experience suggests implantation of this type of THV in aortic annuli up to 32 mm to be feasible and safe, in particular calcification patterns. It does not result in a relevant incidence of PVL ≥ grade II, or increased rate of VARC-2 adjudicated clinical endpoints. Also, functional outcomes regarding transvalvular gradients or EOA demonstrate applicability of this THV in such patients.

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Abbreviations

EOA:

Effective orifice area

logEuroSCORE:

Logistic European System for Cardiac Operative Risk Evaluation

LVOT:

Left ventricular outflow tract

MSCT:

Multi-slice computed tomography

NYHA:

New York Heart Association

PVL:

Paravalvular leakage

S3:

Edwards Sapien 3

SAVR:

Surgical aortic valve replacement

STS PROM:

Society of Thoracic Surgeons Predicted Risk of Mortality

TA:

Transapical

TAVI:

Transcatheter aortic valve implantation

Tax:

Transaxilary

TEE:

Transesophageal echocardiography

TF:

Transfemoral

THV:

Transcatheter heart valve

TTE:

Transthoracic echocardiography

TVL:

Transvalvular leakage

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, Matthias Linder, Yvonne Schneeberger, Hermann Reichenspurner & Lenard Conradi

  2. Department of Cardiac and Thoracic Surgery, University Hospital Halle, Ernst-Grube-Straße 40, 06120, Halle (Saale), Germany

    Hendrik Treede

  3. Department of General and Interventional Cardiology, University Heart Center Hamburg, Martinistraße 52, 20246, Hamburg, Germany

    Florian Deuschl, Niklas Schofer, Moritz Seiffert, Stefan Blankenberg & Ulrich Schaefer

Authors
  1. Andreas Schaefer
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  2. Matthias Linder
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  3. Hendrik Treede
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  4. Florian Deuschl
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  5. Niklas Schofer
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  6. Moritz Seiffert
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  7. Yvonne Schneeberger
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  8. Stefan Blankenberg
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  9. Hermann Reichenspurner
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  10. Ulrich Schaefer
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  11. Lenard Conradi
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Corresponding author

Correspondence to Andreas Schaefer.

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Conflict of interest

Lenard Conradi, Hendrik Treede and Ulrich Schaefer are consultants for Edwards Lifesciences.

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Schaefer, A., Linder, M., Treede, H. et al. Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions. Clin Res Cardiol 105, 585–591 (2016). https://doi.org/10.1007/s00392-015-0954-9

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  • DOI: https://doi.org/10.1007/s00392-015-0954-9

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