Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry

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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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 languageEnglish
Article numberezw406
Pages (from-to)919-926
Number of pages8
JournalEuropean Journal of Cardio-thoracic Surgery
Volume51
Issue number5
DOIs
Publication statusPublished - May 1 2017

Fingerprint

Registries
Conversion to Open Surgery
Safety
Transcatheter Aortic Valve Replacement
Catheters
Stroke
Hemorrhage
Mortality

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 journalArticle

Bonaros, N, Petzina, R, Cocchieri, R, Jagielak, D, Aiello, M, Lapeze, J, Laine, M, Chocron, S, Muir, D, Eichinger, W, Thielmann, M, Labrousse, L, Bapat, V, Rein, KA, Verhoye, JP, Gerosa, G, Baumbach, H, Kofler, M, Bramlage, P, Deutsch, C, Thoenes, M, Frank, D & Romano, M 2017, 'Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry', European Journal of Cardio-thoracic Surgery, vol. 51, no. 5, ezw406, pp. 919-926. https://doi.org/10.1093/ejcts/ezw406
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. / Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry. In: European Journal of Cardio-thoracic Surgery. 2017 ; Vol. 51, No. 5. pp. 919-926.
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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.",
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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

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