Skip to main content
SpringerLink
Log in

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

  • Original Paper
  • Published:
Clinical Research in Cardiology Aims and scope Submit manuscript

Abstract

Aims

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).

Conclusions

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%.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M (2012) Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 33(19):2451–2496. https://doi.org/10.1093/eurheartj/ehs109

    Article  PubMed  Google Scholar 

  2. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG (2016) Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 374(17):1609–1620. https://doi.org/10.1056/NEJMoa1514616

    Article  PubMed  CAS  Google Scholar 

  3. Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP (2017) Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. https://doi.org/10.1056/NEJMoa1700456

    Article  PubMed  Google Scholar 

  4. Frerker C, Bestehorn K, Schluter M, Bestehorn M, Hamm CW, Mollmann H, Katus HA, Kuck KH (2017) In-hospital mortality in propensity-score matched low-risk patients undergoing routine isolated surgical or transfemoral transcatheter aortic valve replacement in 2014 in Germany. Clin Res Cardiol 106(8):610–617. https://doi.org/10.1007/s00392-017-1097-y

    Article  PubMed  Google Scholar 

  5. Athappan G, Gajulapalli RD, Tuzcu ME, Svensson LG, Kapadia SR (2016) A systematic review on the safety of second-generation transcatheter aortic valves. EuroIntervention J EuroPCR Collab Work Group Interv Cardiol Eur Soc Cardiol 11(9):1034–1043. https://doi.org/10.4244/EIJV11I9A211

    Article  Google Scholar 

  6. Mollmann H, Diemert P, Grube E, Baldus S, Kempfert J, Abizaid A (2013) Symetis ACURATE TF aortic bioprosthesis. EuroIntervention J EuroPCR Collab Work Group Interv Cardiol Eur Soc Cardiol 9(Suppl):S107–S110. https://doi.org/10.4244/EIJV9SSA22

    Article  Google Scholar 

  7. Fujita B, Kutting M, Seiffert M, Scholtz S, Egron S, Prashovikj E, Borgermann J, Schafer T, Scholtz W, Preuss R, Gummert J, Steinseifer U, Ensminger SM (2016) Calcium distribution patterns of the aortic valve as a risk factor for the need of permanent pacemaker implantation after transcatheter aortic valve implantation. Eur Heart J Cardiovascular Imaging. https://doi.org/10.1093/ehjci/jev343

    Article  Google Scholar 

  8. Khalique OK, Hahn RT, Gada H, Nazif TM, Vahl TP, George I, Kalesan B, Forster M, Williams MB, Leon MB, Einstein AJ, Pulerwitz TC, Pearson GD, Kodali SK (2014) Quantity and location of aortic valve complex calcification predicts severity and location of paravalvular regurgitation and frequency of post-dilation after balloon-expandable transcatheter aortic valve replacement. JACC Cardiovasc Interv 7(8):885–894. https://doi.org/10.1016/j.jcin.2014.03.007

    Article  PubMed  Google Scholar 

  9. Latsios G, Gerckens U, Buellesfeld L, Mueller R, John D, Yuecel S, Syring J, Sauren B, Grube E (2010) “Device landing zone” calcification, assessed by MSCT, as a predictive factor for pacemaker implantation after TAVI. Catheter Cardiovasc Interv 76(3):431–439. https://doi.org/10.1002/ccd.22563

    Article  PubMed  Google Scholar 

  10. Mauri V, Reimann A, Stern D, Scherner M, Kuhn E, Rudolph V, Rosenkranz S, Eghbalzadeh K, Friedrichs K, Wahlers T, Baldus S, Madershahian N, Rudolph TK (2016) Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3. JACC Cardiovasc Interv 9(21):2200–2209. https://doi.org/10.1016/j.jcin.2016.08.034

    Article  PubMed  Google Scholar 

  11. Kim WK, Blumenstein J, Liebetrau C, Rolf A, Gaede L, Van Linden A, Arsalan M, Doss M, Tijssen JGP, Hamm CW, Walther T, Mollmann H (2017) Comparison of outcomes using balloon-expandable versus self-expanding transcatheter prostheses according to the extent of aortic valve calcification. Clin Res Cardiol 106(12):995–1004. https://doi.org/10.1007/s00392-017-1149-3

    Article  PubMed  Google Scholar 

  12. Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB (2013) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg 145(1):6–23. https://doi.org/10.1016/j.jtcvs.2012.09.002

    Article  PubMed  Google Scholar 

  13. Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, Tarantini G, Sinning JM, Nickenig G, Capodanno D, Tamburino C, Latib A, Colombo A, Kapadia SR (2013) Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 61(15):1585–1595. https://doi.org/10.1016/j.jacc.2013.01.047

    Article  PubMed  Google Scholar 

  14. Kodali S, Pibarot P, Douglas PS, Williams M, Xu K, Thourani V, Rihal CS, Zajarias A, Doshi D, Davidson M, Tuzcu EM, Stewart W, Weissman NJ, Svensson L, Greason K, Maniar H, Mack M, Anwaruddin S, Leon MB, Hahn RT (2015) Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J 36(7):449–456. https://doi.org/10.1093/eurheartj/ehu384

    Article  PubMed  Google Scholar 

  15. Buellesfeld L, Stortecky S, Heg D, Gloekler S, Meier B, Wenaweser P, Windecker S (2014) Extent and distribution of calcification of both the aortic annulus and the left ventricular outflow tract predict aortic regurgitation after transcatheter aortic valve replacement. EuroIntervention J EuroPCR Collab Working Group Interv Cardiol Eur Soc Cardiol 10 (6):732–738. https://doi.org/10.4244/EIJV10I6A126

    Article  Google Scholar 

  16. Seiffert M, Fujita B, Avanesov M, Lunau C, Schon G, Conradi L, Prashovikj E, Scholtz S, Borgermann J, Scholtz W, Schafer U, Lund G, Ensminger S, Treede H (2016) Device landing zone calcification and its impact on residual regurgitation after transcatheter aortic valve implantation with different devices. Eur Heart J Cardiovasc Imaging 17(5):576–584. https://doi.org/10.1093/ehjci/jev174

    Article  PubMed  Google Scholar 

  17. Ewe SH, Ng AC, Schuijf JD, van der Kley F, Colli A, Palmen M, de Weger A, Marsan NA, Holman ER, de Roos A, Schalij MJ, Bax JJ, Delgado V (2011) Location and severity of aortic valve calcium and implications for aortic regurgitation after transcatheter aortic valve implantation. Am J Cardiol 108(10):1470–1477. https://doi.org/10.1016/j.amjcard.2011.07.007

    Article  PubMed  CAS  Google Scholar 

  18. Koos R, Mahnken AH, Dohmen G, Brehmer K, Gunther RW, Autschbach R, Marx N, Hoffmann R (2011) Association of aortic valve calcification severity with the degree of aortic regurgitation after transcatheter aortic valve implantation. Int J Cardiol 150(2):142–145. https://doi.org/10.1016/j.ijcard.2010.03.004

    Article  PubMed  Google Scholar 

  19. Feuchtner G, Plank F, Bartel T, Mueller S, Leipsic J, Schachner T, Muller L, Friedrich G, Klauser A, Grimm M, Bonaros N (2013) Prediction of paravalvular regurgitation after transcatheter aortic valve implantation by computed tomography: value of aortic valve and annular calcification. Ann Thorac Surg 96(5):1574–1580. https://doi.org/10.1016/j.athoracsur.2013.06.049

    Article  PubMed  Google Scholar 

  20. Fonseca P, Figueiredo B, Almeida C, Almeida J, Bettencourt N, Sampaio F, Ferreira N, Goncalves H, Braga P, Ribeiro VG (2016) Aortic valve calcium volume predicts paravalvular regurgitation and the need for balloon post-dilatation after transcatheter aortic valve implantation. J Interv Cardiol 29(1):117–123. https://doi.org/10.1111/joic.12267

    Article  PubMed  Google Scholar 

  21. Kawashima T, Sato F (2014) Visualizing anatomical evidences on atrioventricular conduction system for TAVI. Int J Cardiol 174(1):1–6. https://doi.org/10.1016/j.ijcard.2014.04.003

    Article  PubMed  Google Scholar 

  22. Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK (2015) Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. J Am Coll Cardiol Intv 8(1 Pt A):60–69. https://doi.org/10.1016/j.jcin.2014.07.022

    Article  Google Scholar 

  23. Siontis GC, Juni P, Pilgrim T, Stortecky S, Bullesfeld L, Meier B, Wenaweser P, Windecker S (2014) Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. J Am Coll Cardiol 64(2):129–140. https://doi.org/10.1016/j.jacc.2014.04.033

    Article  PubMed  Google Scholar 

  24. Abdel-Wahab M, Mehilli J, Frerker C, Neumann FJ, Kurz T, Tolg R, Zachow D, Guerra E, Massberg S, Schafer U, El-Mawardy M, Richardt G (2014) Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA 311(15):1503–1514. https://doi.org/10.1001/jama.2014.3316

    Article  PubMed  CAS  Google Scholar 

  25. Chieffo A, Buchanan GL, Van Mieghem NM, Tchetche D, Dumonteil N, Latib A, van der Boon RM, Vahdat O, Marcheix B, Farah B, Serruys PW, Fajadet J, Carrie D, de Jaegere PP, Colombo A (2013) Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration). J Am Coll Cardiol 61(8):830–836. https://doi.org/10.1016/j.jacc.2012.11.050

    Article  PubMed  Google Scholar 

  26. Husser O, Kim WK, Pellegrini C, Holzamer A, Walther T, Mayr PN, Joner M, Kasel AM, Trenkwalder T, Michel J, Rheude T, Kastrati A, Schunkert H, Burgdorf C, Hilker M, Mollmann H, Hengstenberg C (2017) Multicenter comparison of novel self-expanding versus balloon-expandable transcatheter heart valves. JACC Cardiovasc Interv 10(20):2078–2087. https://doi.org/10.1016/j.jcin.2017.06.026

    Article  PubMed  Google Scholar 

  27. Krackhardt F, Kherad B, Krisper M, Pieske B, Laule M, Tschope C (2017) Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol. Cardiol J. https://doi.org/10.5603/CJ.a2017.0024

    Article  PubMed  Google Scholar 

  28. Petronio AS, Sinning JM, Van Mieghem N, Zucchelli G, Nickenig G, Bekeredjian R, Bosmans J, Bedogni F, Branny M, Stangl K, Kovac J, Schiltgen M, Kraus S, de Jaegere P (2015) Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the medtronic corevalve system: the corevalve prospective, international, post-market ADVANCE-II Study. J Am Coll Cardiol Intv 8(6):837–846. https://doi.org/10.1016/j.jcin.2015.02.005

    Article  Google Scholar 

  29. Ledwoch J, Franke J, Gerckens U, Kuck KH, Linke A, Nickenig G, Krulls-Munch J, Vohringer M, Hambrecht R, Erbel R, Richardt G, Horack M, Zahn R, Senges J, Sievert H (2013) Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry. Cathet Cardiovasc Interv 82(4):E569–E577. https://doi.org/10.1002/ccd.24915

    Article  Google Scholar 

  30. Fadahunsi OO, Olowoyeye A, Ukaigwe A, Li Z, Vora AN, Vemulapalli S, Elgin E, Donato A (2016) Incidence, predictors, and outcomes of permanent pacemaker implantation following transcatheter aortic valve replacement: analysis from the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry. JACC Cardiovasc Interv 9(21):2189–2199. https://doi.org/10.1016/j.jcin.2016.07.026

    Article  PubMed  Google Scholar 

Download references

Author information

Author notes

  1. Victor Mauri and Florian Deuschl contributed equally to this work.

Authors and Affiliations

  1. Department of Cardiology, Heart Center, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany

    Victor Mauri, Thomas Frohn, Volker Rudolph & Tanja K. Rudolph

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

    Florian Deuschl, Niklas Schofer & Ulrich Schäfer

  3. Department for Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany

    Matthias Linder, Andreas Schaefer & Lenard Conradi

  4. Department of Cardiothoracic Surgery, Heart Center, University of Cologne, Cologne, Germany

    Elmar Kuhn & Navid Madershahian

Authors
  1. Victor Mauri
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Florian Deuschl
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Thomas Frohn
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Niklas Schofer
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Matthias Linder
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Elmar Kuhn
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Andreas Schaefer
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Volker Rudolph
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Navid Madershahian
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Lenard Conradi
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Tanja K. Rudolph
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Ulrich Schäfer
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding authors

Correspondence to Tanja K. Rudolph or Ulrich Schäfer.

Ethics declarations

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.

Additional information

Tanja K. Rudolph and Ulrich Schäfer jointly directed this work.

Electronic supplementary material

Below is the link to the electronic supplementary material.

392_2018_1235_MOESM1_ESM.tif

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

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

Supplementary Fig. 3: Post-dilation and calcium volume. The rate of post-dilation increased with increasing calcium volume. (TIFF 315 KB)

Supplementary material 4 (DOCX 3394 KB)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Mauri, V., Deuschl, F., Frohn, T. et al. Predictors of paravalvular regurgitation and permanent pacemaker implantation after TAVR with a next-generation self-expanding device. Clin Res Cardiol 107, 688–697 (2018). https://doi.org/10.1007/s00392-018-1235-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00392-018-1235-1

Keyword

Search

Navigation