Skip to main content
SpringerLink
Log in

Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study

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

Abstract

Objectives

We herein aimed to evaluate technical feasibility of transaxillary (Tax) transcatheter aortic valve implantation (TAVI) utilizing a novel vascular closure device with a resorbable collagen plug and absence of suture material.

Methods

Between 05/2018 and 8/2018, eight patients (76.0 ± 5.9 years, 62.5% male, logEuroSCORE I 23.6 ± 4.7) received Tax-TAVI using the MANTA™ vascular closure device. Implanted transcatheter heart valves consisted of Edwards Sapien 3, NVT Allegra, Medtronic CoreValve EvolutR and SJM Portico.

Results

Puncture location depth was variable (3.5–7.5 cm). The left subclavian artery was used in five cases, the right subclavian artery in three cases. Low-pressure balloon-angioplasty for vessel closure was performed in 5/8 patients. VARC-2 defined device success was met in all patients. Major access site complication occurred in one patient with aneurysma spurium of the subclavian artery and consecutive stent implantation on postoperative day 5.

Conclusion

The MANTA™ device is applicable in Tax-TAVI, with potential particular advantages regarding easiness of use and marked access for subsequent interventions in case of vascular complications. Before conclusions regarding clinical efficacy and safety can be made, the device has to be evaluated in larger patient cohorts.

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
Fig. 4

Similar content being viewed by others

Abbreviations

TA:

Transapical

TAVI:

Transcatheter aortic valve implantation

Tax:

Transaxillary

TF:

Transfemoral

THV:

Transcatheter heart valve

References

  1. Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL, ESC Scientific Document Group (2017) 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 38(36):2739–2791

    Article  Google Scholar 

  2. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM, Thompson A (2017) AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 70(2):252–289

    Article  PubMed  Google Scholar 

  3. Schymik G, Würth A, Bramlage P, Herbinger T, Heimeshoff M, Pilz L, Schymik JS, Wondraschek R, Süselbeck T, Gerhardus J, Luik A, Gonska BD, Posival H, Schmitt C, Schröfel H (2014) Long-term results of transapical versus transfemoral TAVI in a real world population of 1000 patients with severe symptomatic aortic stenosis. Circ Cardiovasc Interv 8:1

    Google Scholar 

  4. Grover FL, Vemulapalli S, Carroll JD, Edwards FH, Mack MJ, Thourani VH, Brindis RG, Shahian DM, Ruiz CE, Jacobs JP, Hanzel G, Bavaria JE, Tuzcu EM, Peterson ED, Fitzgerald S, Kourtis M, Michaels J, Christensen B, Seward WF, Hewitt K, Holmes DR Jr, STS/ACC TVT Registry (2017) 2016 annual report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol 69(10):1215–1230

    Article  PubMed  Google Scholar 

  5. Biancari F, Rosato S, D’Errigo P, Ranucci M, Onorati F, Barbanti M, Santini F, Tamburino C, Santoro G, Grossi C, Covello RD, Ventura M, Fusco D, Seccareccia F, OBSERVANT Research Group (2016) Immediate and intermediate outcome after transapical versus transfemoral transcatheter aortic valve replacement. Am J Cardiol 117(2):245–251

    Article  PubMed  Google Scholar 

  6. Blackstone EH, Suri RM, Rajeswaran J, Babaliaros V, Douglas PS, Fearon WF, Miller DC, Hahn RT, Kapadia S, Kirtane AJ, Kodali SK, Mack M, Szeto WY, Thourani VH, Tuzcu EM, Williams MR, Akin JJ, Leon MB, Svensson LG (2015) Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy. Circulation 131(22):1989–2000

    Article  PubMed  Google Scholar 

  7. Schäfer U, Deuschl F, Schofer N, Frerker C, Schmidt T, Kuck KH, Kreidel F, Schirmer J, Mizote I, Reichenspurner H, Blankenberg S, Treede H, Conradi L (2017) Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients. Int J Cardiol 232:247–254

    Article  PubMed  Google Scholar 

  8. Wee IJY, Stonier T, Harrison M, Choong AMTL (2018) Transcarotid transcatheter aortic valve implantation: a systematic review. J Cardiol 71(6):525–533

    Article  PubMed  Google Scholar 

  9. Wee IJY, Syn N, Choong AMTL (2018) Transcaval approach for endovascular aortic interventions: a systematic review. J Cardiol 72(5):369–376

    Article  PubMed  Google Scholar 

  10. Amat-Santos IJ, Rojas P, Gutiérrez H, Vera S, Castrodeza J, Tobar J, Goncalves-Ramirez LR, Carrasco M, Catala P, San Román JA (2018) Transubclavian approach: a competitive access for transcatheter aortic valve implantation as compared to transfemoral. Catheter Cardiovasc Interv

  11. Schäfer U, Ho Y, Frerker C, Schewel D, Sanchez-Quintana D, Schofer J, Bijuklic K, Meincke F, Thielsen T, Kreidel F, Kuck KH (2012) Direct percutaneous access technique for transaxillary transcatheter aortic valve implantation: “the Hamburg Sankt Georg approach”. JACC Cardiovasc Interv 5(5):477–486

    Article  PubMed  Google Scholar 

  12. Deuschl F, Schofer N, Seiffert M, Hakmi S, Mizote I, Schaefer A, Schirmer J, Reichenspurner H, Blankenberg S, Conradi L, Schäfer U (2017) Direct percutaneous transaxillary implantation of a novel self-expandable transcatheter heart valve for aortic stenosis. Catheter Cardiovasc Interv 90(7):1167–1174

    Article  PubMed  Google Scholar 

  13. https://clinicaltrials.gov/ct2/show/NCT02908880. Accessed 08 Jan 2018

  14. De Palma R, Rück A, Settergren M, Saleh N (2018) Percutaneous axillary arteriotomy closure during transcatheter aortic valve replacement using the MANTA device. Catheter Cardiovasc Interv 92(5):998–1001

    Article  PubMed  Google Scholar 

  15. Kroon HG, De Jaegere PP, Van Mieghem NM (2018) Plug based closure in completely percutaneous right-sided transaxillary transcatheter aortic valve implantation. EuroIntervention. https://doi.org/10.4244/EIJ-D-18-00700

    Article  Google Scholar 

  16. Schaefer A, Linder M, Treede H, Deuschl F, Schofer N, Seiffert M, Schneeberger Y, Blankenberg S, Reichenspurner H, Schaefer U, Conradi L (2016) Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions. Clin Res Cardiol 105(7):585–591

    Article  PubMed  Google Scholar 

  17. Kappetein AP, Head SJ, Généreux 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, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB, Valve Academic Research Consortium-2 (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

    Article  PubMed  Google Scholar 

  18. Wijeysundera HC, Qiu F, Koh M, Prasad TJ, Cantor WJ, Cheema A, Chu MW, Czarnecki A, Feindel C, Fremes SE, Kingsbury KJ, Natarajan MK, Peterson M, Ruel M, Strauss B, Ko DT (2017) Comparison of outcomes of balloon-expandable versus self-expandable transcatheter heart valves for severe aortic stenosis. Am J Cardiol 119(7):1094–1099

    Article  PubMed  Google Scholar 

  19. Kochman J, Kołtowski Ł, Huczek Z, Rymuza B, Wilimski R, Dąbrowski M, Witkowski A, Grygier M, Olasińska-Wiśniewska A, Kubler P, Reczuch K, Parma R, Ochała A, Jagielak D, Kochman W, Grube E (2018) Complete percutaneous approach versus surgical access in transfemoral transcatheter aortic valve implantation: results from a multicentre registry. Kardiol Pol 76(1):202–208

    Article  PubMed  Google Scholar 

  20. Ott I, Shivaraju A, Schäffer NR, Frangieh AH, Michel J, Husser O, Hengstenberg C, Mayr P, Colleran R, Pellegrini C, Cassese S, Fusaro M, Schunkert H, Kastrati A, Kasel AM (2017) Parallel suture technique with ProGlide: a novel method for management of vascular access during transcatheter aortic valve implantation (TAVI). EuroIntervention 13(8):928–934

    Article  PubMed  Google Scholar 

  21. Van Mieghem NM, Latib A, van der Heyden J, van Gils L, Daemen J, Sorzano T, Ligthart J, Witberg K, de Kroon T, Maor N, Mangieri A, Montorfano M, de Jaegere PP, Colombo A, Roubin G (2017) Percutaneous plug-based arteriotomy closure device for large-bore access: a multicenter prospective study. JACC Cardiovasc Interv 10(6):613–619

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

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

    Andreas Schaefer, Johannes Schirmer, 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

Authors
  1. Andreas Schaefer
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Johannes Schirmer
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Niklas Schofer
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yvonne Schneeberger
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Florian Deuschl
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Stefan Blankenberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Hermann Reichenspurner
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Lenard Conradi
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Ulrich Schäfer
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Andreas Schaefer.

Ethics declarations

Conflict of interest

A. Schaefer received travel compensation from Symetis SA and Abbott Vascular Inc. L. Conradi is a Proctor for Symetis SA and Edwards Lifesciences Inc. and received travel support and lecture fees from Abbott Vascular Inc., Edwards Lifescieences Inc., Boston Scientific Co. and Medtronic PLC. U. Schäfer is a Proctor for Symetis SA, Medtronic, Bostons Sci, Edwards Lifesciences Inc.; New Valve Technology, Abbott Vascular, and received travel support and lecture fees from Symetis SA, Medtronic, Bostons Sci, Edwards Lifesciences Inc.; New Valve Technology, Abbott Vascular.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Schaefer, A., Schirmer, J., Schofer, N. et al. Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study. Clin Res Cardiol 108, 779–786 (2019). https://doi.org/10.1007/s00392-018-1407-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00392-018-1407-z

Keywords

Search

Navigation