Clinical Research in Cardiology

, Volume 107, Issue 8, pp 688–697 | Cite as

Predictors of paravalvular regurgitation and permanent pacemaker implantation after TAVR with a next-generation self-expanding device

  • Victor Mauri
  • Florian Deuschl
  • Thomas Frohn
  • Niklas Schofer
  • Matthias Linder
  • Elmar Kuhn
  • Andreas Schaefer
  • Volker Rudolph
  • Navid Madershahian
  • Lenard Conradi
  • Tanja K. Rudolph
  • Ulrich Schäfer
Original Paper



To identify predictors of paravalvular regurgitation (PVR) and permanent pacemaker implantation (PPI) following TAVR with a next-generation self-expanding device.

Methods and results

Device landing zone (DLZ) calcification, angiographic implantation depth, and baseline and procedural characteristics were analyzed in 212 patients being treated with the ACURATE neo aortic bioprosthesis. PVR was none/trace in 57.1% and ≥ mild in 42.9% (37% mild, 6% moderate). DLZ calcification (705 (IQR 240–624) vs. 382 (IQR 240–624) mm3; P < 0.001) as well as absolute calcium asymmetry (233 ± 159 vs. 151 ± 151 mm3; P < 0.001) was significantly higher in patients with PVR ≥ mild. On multivariate analysis, calcification of the aortic valve cusps (AVC) > 410.6 mm3 was independently associated with PVR ≥ mild. PPI rate was 10.3% (n = 20). Patients with and without need for PPI had similar total DLZ calcium volume (740 (IQR 378–920) vs. 536 (IQR 315–822) mm3; P = 0.263), but exhibited different calcium distribution patterns: LVOT calcium > 41.4 mm3 in the sector below the left coronary cusp (LVOTLC) was associated with increased PPI risk (26.9 vs. 7.7%; P = 0.008).


The quantity of AVC calcium predicts residual PVR. Multivariable analysis identified LVOTLC calcium, pre-existing RBBB, and age > 82.7 years as independent predictors of PPI. Based on these risk factors, a patient’s individual PPI risk can be stratified ranging from 3.8 to 100%.


Transcatheter aortic valve replacement Permanent pacemaker implantation Paravalvular regurgitation Prediction of risk ACURATE neo TF Calcium distribution 


Compliance with ethical standards

Conflict of interest

Lenard Conradi, Tanja Rudolph, and Ulrich Schäfer are proctors for Symetis. Hamburg Heart Center is a training site for transfemoral and transapical Symetis TAVI training. All other authors report no conflict of interest.

Supplementary material

392_2018_1235_MOESM1_ESM.tif (58 kb)
Supplementary Fig. 1: ACURATE neo device. Flexible stabilization arches and an upper crown allow supra-annular anchoring and capture the native leaflets. An outer and inner pericardial anti-PVR skirt provides sealing against paravalvular regurgitation. The valve exerts only intermediate radial force and the lower crown protrudes only minimally into the LVOT. (TIF 57 KB)
392_2018_1235_MOESM2_ESM.tiff (735 kb)
Supplementary Fig. 2: ROC analysis for the prediction of PVR ≥mild. ROC curves for the prediction of PVR ≥mild by A: calcium volume for each region, and B: absolute asymmetry for each region. (TIFF 735 KB)
392_2018_1235_MOESM3_ESM.tiff (316 kb)
Supplementary Fig. 3: Post-dilation and calcium volume. The rate of post-dilation increased with increasing calcium volume. (TIFF 315 KB)
392_2018_1235_MOESM4_ESM.docx (3.3 mb)
Supplementary material 4 (DOCX 3394 KB)


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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Victor Mauri
    • 1
  • Florian Deuschl
    • 2
  • Thomas Frohn
    • 1
  • Niklas Schofer
    • 2
  • Matthias Linder
    • 3
  • Elmar Kuhn
    • 4
  • Andreas Schaefer
    • 3
  • Volker Rudolph
    • 1
  • Navid Madershahian
    • 4
  • Lenard Conradi
    • 3
  • Tanja K. Rudolph
    • 1
  • Ulrich Schäfer
    • 2
  1. 1.Department of Cardiology, Heart CenterUniversity of CologneCologneGermany
  2. 2.Department of General and Interventional CardiologyUniversity Heart Center HamburgHamburgGermany
  3. 3.Department for Cardiovascular SurgeryUniversity Heart Center HamburgHamburgGermany
  4. 4.Department of Cardiothoracic Surgery, Heart CenterUniversity of CologneCologneGermany

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