Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry

Mauro Romano, Derk Frank, Riccardo Cocchieri, Dariusz Jagielak, Nikolaos Bonaros, Marco Aiello, Joel Lapeze, Mika Laine, Sidney Chocron, Douglas Muir, Walter Eichinger, Matthias Thielmann, Louis Labrousse, Kjell Arne Rein, Jean Philippe Verhoye, Gino Gerosa, Hardy Baumbach, Cornelia Deutsch, Peter Bramlage, Martin ThoenesVinayak Bapat

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

OBJECTIVES Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. METHODS ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. RESULTS Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-To-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group. CONCLUSIONS Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. ClinicalTrials.gov Identifier NCT01991431.

Original languageEnglish
Pages (from-to)757-764
Number of pages8
JournalInteractive Cardiovascular and Thoracic Surgery
Volume25
Issue number5
DOIs
Publication statusPublished - Nov 1 2017

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Registries
Heart Valves
Contrast Media
Blood Vessels
Dilatation
Mortality
Transcatheter Aortic Valve Replacement

Keywords

  • Balloon expandable
  • Mortality
  • Transaortic
  • Transcatheter aortic valve implantation

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry. / Romano, Mauro; Frank, Derk; Cocchieri, Riccardo; Jagielak, Dariusz; Bonaros, Nikolaos; Aiello, Marco; Lapeze, Joel; Laine, Mika; Chocron, Sidney; Muir, Douglas; Eichinger, Walter; Thielmann, Matthias; Labrousse, Louis; Arne Rein, Kjell; Verhoye, Jean Philippe; Gerosa, Gino; Baumbach, Hardy; Deutsch, Cornelia; Bramlage, Peter; Thoenes, Martin; Bapat, Vinayak.

In: Interactive Cardiovascular and Thoracic Surgery, Vol. 25, No. 5, 01.11.2017, p. 757-764.

Research output: Contribution to journalArticle

Romano, M, Frank, D, Cocchieri, R, Jagielak, D, Bonaros, N, Aiello, M, Lapeze, J, Laine, M, Chocron, S, Muir, D, Eichinger, W, Thielmann, M, Labrousse, L, Arne Rein, K, Verhoye, JP, Gerosa, G, Baumbach, H, Deutsch, C, Bramlage, P, Thoenes, M & Bapat, V 2017, 'Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry', Interactive Cardiovascular and Thoracic Surgery, vol. 25, no. 5, pp. 757-764. https://doi.org/10.1093/icvts/ivx159
Romano, Mauro ; Frank, Derk ; Cocchieri, Riccardo ; Jagielak, Dariusz ; Bonaros, Nikolaos ; Aiello, Marco ; Lapeze, Joel ; Laine, Mika ; Chocron, Sidney ; Muir, Douglas ; Eichinger, Walter ; Thielmann, Matthias ; Labrousse, Louis ; Arne Rein, Kjell ; Verhoye, Jean Philippe ; Gerosa, Gino ; Baumbach, Hardy ; Deutsch, Cornelia ; Bramlage, Peter ; Thoenes, Martin ; Bapat, Vinayak. / Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry. In: Interactive Cardiovascular and Thoracic Surgery. 2017 ; Vol. 25, No. 5. pp. 757-764.
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abstract = "OBJECTIVES Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. METHODS ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. RESULTS Of the 301 patients included, 126 (41.9{\%}) received a SAPIEN 3 and 175 (58.1{\%}) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0{\%} vs 78.3{\%}; P = 0.045) and after implantation (13.6{\%} vs 30.1{\%}; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1{\%} SAPIEN 3 vs 7.6{\%} SAPIEN XT; P = 0.21), TAVI-related (0.8{\%} vs 4.7{\%}; P = 0.084) and cardiovascular mortality (2.4{\%} vs 5.9{\%}; P = 0.158). Major vascular complications were less frequent (0.8{\%} vs 5.3{\%}; P = 0.049), and there was a lower rate of moderate-To-severe paravalvular regurgitation (0.8{\%} vs 5.1{\%}; P = 0.050) in the SAPIEN 3 group. CONCLUSIONS Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. ClinicalTrials.gov Identifier NCT01991431.",
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T1 - Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry

AU - Romano, Mauro

AU - Frank, Derk

AU - Cocchieri, Riccardo

AU - Jagielak, Dariusz

AU - Bonaros, Nikolaos

AU - Aiello, Marco

AU - Lapeze, Joel

AU - Laine, Mika

AU - Chocron, Sidney

AU - Muir, Douglas

AU - Eichinger, Walter

AU - Thielmann, Matthias

AU - Labrousse, Louis

AU - Arne Rein, Kjell

AU - Verhoye, Jean Philippe

AU - Gerosa, Gino

AU - Baumbach, Hardy

AU - Deutsch, Cornelia

AU - Bramlage, Peter

AU - Thoenes, Martin

AU - Bapat, Vinayak

PY - 2017/11/1

Y1 - 2017/11/1

N2 - OBJECTIVES Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. METHODS ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. RESULTS Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-To-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group. CONCLUSIONS Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. ClinicalTrials.gov Identifier NCT01991431.

AB - OBJECTIVES Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. METHODS ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. RESULTS Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-To-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group. CONCLUSIONS Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. ClinicalTrials.gov Identifier NCT01991431.

KW - Balloon expandable

KW - Mortality

KW - Transaortic

KW - Transcatheter aortic valve implantation

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