Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry

Vinayak Bapat, Derk Frank, Ricardo 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, Peter Bramlage, Cornelia Deutsch, Martin ThoenesMauro Romano

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431).

BACKGROUND: TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.

METHODS: ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.

RESULTS: A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation.

CONCLUSIONS: TAo access for TAVR seems to be a safe alternative to the transapical procedure.

Original languageEnglish
Pages (from-to)1815-22
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume9
Issue number17
DOIs
Publication statusPublished - Sep 12 2016

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Registries
Mortality
Safety
Transient Ischemic Attack
Acute Kidney Injury
Surgical Instruments
Blood Vessels
Transcatheter Aortic Valve Replacement
Stroke
Myocardial Infarction
Hemorrhage
Research

Keywords

  • Journal Article

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Transcatheter Aortic Valve Replacement Using Transaortic Access : Experience From the Multicenter, Multinational, Prospective ROUTE Registry. / Bapat, Vinayak; Frank, Derk; Cocchieri, Ricardo; Jagielak, Dariusz; Bonaros, Nikolaos; Aiello, Marco; Lapeze, Joel; Laine, Mika; Chocron, Sidney; Muir, Douglas; Eichinger, Walter; Thielmann, Matthias; Labrousse, Louis; Rein, Kjell Arne; Verhoye, Jean-Philippe; Gerosa, Gino; Baumbach, Hardy; Bramlage, Peter; Deutsch, Cornelia; Thoenes, Martin; Romano, Mauro.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 17, 12.09.2016, p. 1815-22.

Research output: Contribution to journalArticle

Bapat, V, Frank, D, Cocchieri, R, Jagielak, D, Bonaros, N, Aiello, M, Lapeze, J, Laine, M, Chocron, S, Muir, D, Eichinger, W, Thielmann, M, Labrousse, L, Rein, KA, Verhoye, J-P, Gerosa, G, Baumbach, H, Bramlage, P, Deutsch, C, Thoenes, M & Romano, M 2016, 'Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry', JACC: Cardiovascular Interventions, vol. 9, no. 17, pp. 1815-22. https://doi.org/10.1016/j.jcin.2016.06.031
Bapat, Vinayak ; Frank, Derk ; Cocchieri, Ricardo ; Jagielak, Dariusz ; Bonaros, Nikolaos ; Aiello, Marco ; Lapeze, Joel ; Laine, Mika ; Chocron, Sidney ; Muir, Douglas ; Eichinger, Walter ; Thielmann, Matthias ; Labrousse, Louis ; Rein, Kjell Arne ; Verhoye, Jean-Philippe ; Gerosa, Gino ; Baumbach, Hardy ; Bramlage, Peter ; Deutsch, Cornelia ; Thoenes, Martin ; Romano, Mauro. / Transcatheter Aortic Valve Replacement Using Transaortic Access : Experience From the Multicenter, Multinational, Prospective ROUTE Registry. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 17. pp. 1815-22.
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abstract = "OBJECTIVES: The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431).BACKGROUND: TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.METHODS: ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.RESULTS: A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6{\%} were included. Valve success was documented in 96.7{\%}. The 30-day mortality was 6.1{\%} (18/293) (procedure-related mortality: 3.1{\%}; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0{\%}), stroke (1.0{\%}), transient ischemic attack (0.3{\%}), major vascular complications (3.4{\%}), life-threatening bleeding (3.4{\%}), and acute kidney injury (9.5{\%}). In 3.3{\%} of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8{\%}) required permanent pacemaker implantation.CONCLUSIONS: TAo access for TAVR seems to be a safe alternative to the transapical procedure.",
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T1 - Transcatheter Aortic Valve Replacement Using Transaortic Access

T2 - Experience From the Multicenter, Multinational, Prospective ROUTE Registry

AU - Bapat, Vinayak

AU - Frank, Derk

AU - Cocchieri, Ricardo

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 - Rein, Kjell Arne

AU - Verhoye, Jean-Philippe

AU - Gerosa, Gino

AU - Baumbach, Hardy

AU - Bramlage, Peter

AU - Deutsch, Cornelia

AU - Thoenes, Martin

AU - Romano, Mauro

N1 - Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2016/9/12

Y1 - 2016/9/12

N2 - OBJECTIVES: The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431).BACKGROUND: TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.METHODS: ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.RESULTS: A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation.CONCLUSIONS: TAo access for TAVR seems to be a safe alternative to the transapical procedure.

AB - OBJECTIVES: The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431).BACKGROUND: TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.METHODS: ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.RESULTS: A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation.CONCLUSIONS: TAo access for TAVR seems to be a safe alternative to the transapical procedure.

KW - Journal Article

U2 - 10.1016/j.jcin.2016.06.031

DO - 10.1016/j.jcin.2016.06.031

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EP - 1822

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 17

ER -