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 language | English |
|---|---|
| Pages (from-to) | 757-764 |
| Number of pages | 8 |
| Journal | Interactive Cardiovascular and Thoracic Surgery |
| Volume | 25 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Nov 1 2017 |
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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 journal › Article
}
TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=85034779562&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85034779562&partnerID=8YFLogxK
U2 - 10.1093/icvts/ivx159
DO - 10.1093/icvts/ivx159
M3 - Article
AN - SCOPUS:85034779562
VL - 25
SP - 757
EP - 764
JO - Interactive Cardiovascular and Thoracic Surgery
JF - Interactive Cardiovascular and Thoracic Surgery
SN - 1569-9293
IS - 5
ER -