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Transfemoral TAVI without pre-dilatation using balloon-expandable devices: a case-matched analysis

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Abstract

Objectives

This comparative case-matched analysis investigated feasibility and safety of direct transfemoral (TF) transcatheter aortic valve implantation (TAVI) without pre-dilatation using balloon-expandable devices.

Background

Presently, balloon aortic valvuloplasty (BAV) is considered mandatory preceding transfemoral TAVI with balloon-expandable devices. However, procedural severe adverse events may be associated with BAV.

Methods

26 consecutive patients (study group) received direct TF-TAVI using Edwards Sapien XT (n = 17) or Sapien 3 (n = 9) devices (61.5 % female, 81.3 ± 6.3 years, logEuroSCORE I 15.3 ± 13.2 %). A control group of patients after conventional TF-TAVI was retrieved from our database containing 1153 TAVI patients and matched to the study group regarding baseline and procedural data. Data reporting adheres to VARC-2 definitions.

Results

Device success was 96.2 % (25/26) and 92.3 % (24/26) in study and control groups, respectively (p = 1.00). Procedure time (60.0 ± 54.0 vs. 70.0 ± 29.1 min; p = 0.41), fluoroscopy time (13.3 ± 5.8 vs. 17.8 ± 6.9 min; p = 0.01) and amount of contrast agent (118.7 ± 47.9 vs. 153.0 ± 53.2 ml; p = 0.02) were lower in the study group. All-cause 30-day mortality was 7.7 % (2/26) in both groups, disabling stroke was observed in 3.8 % (1/26) and 7.7 % (2/26) in study and control groups, respectively. Resultant transvalvular mean gradient and effective orifice area (EOA) were 11 ± 5 vs. 11 ± 5 mmHg and 1.6 ± 0.3 vs. 1.5 ± 0.3 cm2. Paravalvular leakage ≥grade II was observed in 0 and 7.7 % (2/26; p = 0.49).

Conclusions

TF-TAVI without pre-dilatation was feasible and safe in this consecutive series of patient regardless of aortic valve morphology, for example. extent of valvular calcification or baseline EOA. This technique resulted in significantly lower fluoroscopy times and amounts of contrast agent while yielding non-inferior hemodynamic and clinical outcome.

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Abbreviations

BAV:

Balloon-aortic valvuloplasty

EOA:

Effective orifice area

logEuroSCORE:

Logistic European system for cardiac operative risk evaluation I

MSCT:

Multislice computed tomography

NYHA:

New York Heart Association

PM:

Pacemaker

PVL:

Paravalvular leakage

RVP:

Rapid ventricular pacing

TA:

Transapical

TAVI:

Transcatheter aortic valve implantation

TEE:

Transesophageal echocardiography

TF:

Transfemoral

TTE:

Transthoracic echocardiography

VARC:

Valve Academic Research Consortium

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Conflict of interest

Lenard Conradi, Hendrik Treede, Ulrich Schäfer and Patrick Diemert are consultants to Edwards Lifesciences.

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Author notes

    Authors and Affiliations

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

      Lenard Conradi, Andreas Schaefer, Johannes Schirmer, Hermann Reichenspurner & Hendrik Treede

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

      Moritz Seiffert, Ulrich Schaefer, Stefan Blankenberg & Patrick Diemert

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

      Gerhard Schön

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    1. Lenard Conradi
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    Correspondence to Andreas Schaefer.

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    L. Conradi and A. Schaefer contributed equally to this work.

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    Conradi, L., Schaefer, A., Seiffert, M. et al. Transfemoral TAVI without pre-dilatation using balloon-expandable devices: a case-matched analysis. Clin Res Cardiol 104, 735–742 (2015). https://doi.org/10.1007/s00392-015-0836-1

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