Abstract
Objectives: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. Methods: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. ResultS: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% (P = 0.76), rates of stroke 2% vs. 0% (P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% (P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. Conclusions: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. Clinicaltrials.gov: NCT01991431.
| Original language | English |
|---|---|
| Article number | ezw406 |
| Pages (from-to) | 919-926 |
| Number of pages | 8 |
| Journal | European Journal of Cardio-thoracic Surgery |
| Volume | 51 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - May 1 2017 |
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Keywords
- SAPIEN
- TAVI
- Transaortic
- Transapical
- Transcatheter Aortic Valve Implantation
- Transfemoral
ASJC Scopus subject areas
- Surgery
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine
Cite this
Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry. / Bonaros, Nikolaos; Petzina, Rainer; Cocchieri, Riccardo; Jagielak, Dariusz; Aiello, Marco; Lapeze, Joel; Laine, Mika; Chocron, Sidney; Muir, Douglas; Eichinger, Walter; Thielmann, Matthias; Labrousse, Louis; Bapat, Vinayak; Rein, Kjell Arne; Verhoye, Jean Philippe; Gerosa, Gino; Baumbach, Hardy; Kofler, Markus; Bramlage, Peter; Deutsch, Cornelia; Thoenes, Martin; Frank, Derk; Romano, Mauro.
In: European Journal of Cardio-thoracic Surgery, Vol. 51, No. 5, ezw406, 01.05.2017, p. 919-926.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry
AU - Bonaros, Nikolaos
AU - Petzina, Rainer
AU - Cocchieri, Riccardo
AU - Jagielak, Dariusz
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 - Bapat, Vinayak
AU - Rein, Kjell Arne
AU - Verhoye, Jean Philippe
AU - Gerosa, Gino
AU - Baumbach, Hardy
AU - Kofler, Markus
AU - Bramlage, Peter
AU - Deutsch, Cornelia
AU - Thoenes, Martin
AU - Frank, Derk
AU - Romano, Mauro
PY - 2017/5/1
Y1 - 2017/5/1
N2 - Objectives: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. Methods: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. ResultS: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% (P = 0.76), rates of stroke 2% vs. 0% (P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% (P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. Conclusions: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. Clinicaltrials.gov: NCT01991431.
AB - Objectives: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. Methods: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. ResultS: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% (P = 0.76), rates of stroke 2% vs. 0% (P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% (P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. Conclusions: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. Clinicaltrials.gov: NCT01991431.
KW - SAPIEN
KW - TAVI
KW - Transaortic
KW - Transapical
KW - Transcatheter Aortic Valve Implantation
KW - Transfemoral
UR - http://www.scopus.com/inward/record.url?scp=85019102924&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85019102924&partnerID=8YFLogxK
U2 - 10.1093/ejcts/ezw406
DO - 10.1093/ejcts/ezw406
M3 - Article
AN - SCOPUS:85019102924
VL - 51
SP - 919
EP - 926
JO - European Journal of Cardio-thoracic Surgery
JF - European Journal of Cardio-thoracic Surgery
SN - 1010-7940
IS - 5
M1 - ezw406
ER -