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Erschienen in: Clinical Research in Cardiology 7/2019

17.12.2018 | Original Paper

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

verfasst von: Andreas Schaefer, Johannes Schirmer, Niklas Schofer, Yvonne Schneeberger, Florian Deuschl, Stefan Blankenberg, Hermann Reichenspurner, Lenard Conradi, Ulrich Schäfer

Erschienen in: Clinical Research in Cardiology | Ausgabe 7/2019

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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.
Literatur
1.
Zurück zum Zitat 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):2739–2791CrossRef 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):2739–2791CrossRef
2.
Zurück zum Zitat 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):252–289CrossRefPubMed 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):252–289CrossRefPubMed
3.
Zurück zum Zitat 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 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
4.
Zurück zum Zitat 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):1215–1230CrossRefPubMed 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):1215–1230CrossRefPubMed
5.
Zurück zum Zitat 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):245–251CrossRefPubMed 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):245–251CrossRefPubMed
6.
Zurück zum Zitat 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):1989–2000CrossRefPubMed 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):1989–2000CrossRefPubMed
7.
Zurück zum Zitat 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 232:247–254CrossRefPubMed 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 232:247–254CrossRefPubMed
8.
Zurück zum Zitat Wee IJY, Stonier T, Harrison M, Choong AMTL (2018) Transcarotid transcatheter aortic valve implantation: a systematic review. J Cardiol 71(6):525–533CrossRefPubMed Wee IJY, Stonier T, Harrison M, Choong AMTL (2018) Transcarotid transcatheter aortic valve implantation: a systematic review. J Cardiol 71(6):525–533CrossRefPubMed
9.
Zurück zum Zitat Wee IJY, Syn N, Choong AMTL (2018) Transcaval approach for endovascular aortic interventions: a systematic review. J Cardiol 72(5):369–376CrossRefPubMed Wee IJY, Syn N, Choong AMTL (2018) Transcaval approach for endovascular aortic interventions: a systematic review. J Cardiol 72(5):369–376CrossRefPubMed
10.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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):477–486CrossRefPubMed 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):477–486CrossRefPubMed
12.
Zurück zum Zitat 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):1167–1174CrossRefPubMed 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):1167–1174CrossRefPubMed
14.
Zurück zum Zitat 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):998–1001CrossRefPubMed 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):998–1001CrossRefPubMed
16.
Zurück zum Zitat 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):585–591CrossRefPubMed 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):585–591CrossRefPubMed
17.
Zurück zum Zitat 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):6–23CrossRefPubMed 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):6–23CrossRefPubMed
18.
Zurück zum Zitat 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):1094–1099CrossRefPubMed 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):1094–1099CrossRefPubMed
19.
Zurück zum Zitat 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):202–208CrossRefPubMed 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):202–208CrossRefPubMed
20.
Zurück zum Zitat 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):928–934CrossRefPubMed 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):928–934CrossRefPubMed
21.
Zurück zum Zitat 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):613–619CrossRefPubMed 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):613–619CrossRefPubMed
Metadaten
Titel
Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study
verfasst von
Andreas Schaefer
Johannes Schirmer
Niklas Schofer
Yvonne Schneeberger
Florian Deuschl
Stefan Blankenberg
Hermann Reichenspurner
Lenard Conradi
Ulrich Schäfer
Publikationsdatum
17.12.2018
Verlag
Springer Berlin Heidelberg
Erschienen in
Clinical Research in Cardiology / Ausgabe 7/2019
Print ISSN: 1861-0684
Elektronische ISSN: 1861-0692
DOI
https://doi.org/10.1007/s00392-018-1407-z

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