Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

Eberhard Grube, Nicolas M. Van Mieghem, Sabine Bleiziffer, Thomas Modine, Johan Bosmans, Ganesh Manoharan, Axel Linke, Werner Scholtz, Didier Tchétché, Ariel Finkelstein, Ramiro Trillo, Claudia Fiorina, Antony Walton, Christopher J. Malkin, Jae Kuen Oh, Hongyan Qiao, Stephan Windecker, Eberhard Grube, Stephan Windecker, Johan BosmansSabine Bleiziffer, Ganesh Manoharan, Thomas Modine, Nicolas Van Mieghem, Ajay Sinhal, Robert Gooley, Tony Walton, Gerald Yong, Johan Bosmans, John Webb, Michael Chu, Sam Radhakrishnan, Antonio Dager, Marian Branny, Didier Tchetche, Thomas Modine, Emmanuel Teiger, Bernard Chevalier, Dominique Himbert, Gerhard Schymik, Tobias Zeus, Christoph Jensen, Tienush Rassaf, Stephan Fichtlscherer, Georg Nickenig, Axel Linke, Sabine Bleiziffer, Jörg Kempfert, Werner Scholtz, Axel Harnath, Ruth Strasser, Christian Frerker, Konstantinos Spargias, Béla Peter Merkely, Ariel Finkelstein, Corrado Tamburino, Antonio Colombo, Anna Sonia Petronio, Claudia Fiorina, Francesco Bedogni, Giovanni Amoroso, Jan van der Heijden, Nicolas Van Mieghem, Pim Tonino, Pedro Echeverria Beliz, Adam Witkowski, Vasco Gama Ribeiro, Moheeb Al Abdullah, Hellmuth Weich, Ramiro Trillo, José Maria Hernández García, Cesar Moris, Anders Lars Jönsson, Christopher J. Malkin, Saib Khogali, David Hildick-Smith, Ganesh Manoharan

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)

Original languageEnglish (US)
Pages (from-to)845-853
Number of pages9
JournalJournal of the American College of Cardiology
Volume70
Issue number7
DOIs
StatePublished - Aug 15 2017

Fingerprint

Heart Valves
Aortic Valve Stenosis
Aortic Valve
Mortality
Aortic Valve Insufficiency
Multicenter Studies
Observational Studies
Stroke
Safety
Equipment and Supplies
Research
Population
Transcatheter Aortic Valve Replacement

Keywords

  • aortic stenosis
  • degenerative valve
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis : The International FORWARD Study. / Grube, Eberhard; Van Mieghem, Nicolas M.; Bleiziffer, Sabine; Modine, Thomas; Bosmans, Johan; Manoharan, Ganesh; Linke, Axel; Scholtz, Werner; Tchétché, Didier; Finkelstein, Ariel; Trillo, Ramiro; Fiorina, Claudia; Walton, Antony; Malkin, Christopher J.; Oh, Jae Kuen; Qiao, Hongyan; Windecker, Stephan; Grube, Eberhard; Windecker, Stephan; Bosmans, Johan; Bleiziffer, Sabine; Manoharan, Ganesh; Modine, Thomas; Van Mieghem, Nicolas; Sinhal, Ajay; Gooley, Robert; Walton, Tony; Yong, Gerald; Bosmans, Johan; Webb, John; Chu, Michael; Radhakrishnan, Sam; Dager, Antonio; Branny, Marian; Tchetche, Didier; Modine, Thomas; Teiger, Emmanuel; Chevalier, Bernard; Himbert, Dominique; Schymik, Gerhard; Zeus, Tobias; Jensen, Christoph; Rassaf, Tienush; Fichtlscherer, Stephan; Nickenig, Georg; Linke, Axel; Bleiziffer, Sabine; Kempfert, Jörg; Scholtz, Werner; Harnath, Axel; Strasser, Ruth; Frerker, Christian; Spargias, Konstantinos; Merkely, Béla Peter; Finkelstein, Ariel; Tamburino, Corrado; Colombo, Antonio; Petronio, Anna Sonia; Fiorina, Claudia; Bedogni, Francesco; Amoroso, Giovanni; van der Heijden, Jan; Van Mieghem, Nicolas; Tonino, Pim; Echeverria Beliz, Pedro; Witkowski, Adam; Gama Ribeiro, Vasco; Al Abdullah, Moheeb; Weich, Hellmuth; Trillo, Ramiro; Hernández García, José Maria; Moris, Cesar; Jönsson, Anders Lars; Malkin, Christopher J.; Khogali, Saib; Hildick-Smith, David; Manoharan, Ganesh.

In: Journal of the American College of Cardiology, Vol. 70, No. 7, 15.08.2017, p. 845-853.

Research output: Contribution to journalArticle

Grube, E, Van Mieghem, NM, Bleiziffer, S, Modine, T, Bosmans, J, Manoharan, G, Linke, A, Scholtz, W, Tchétché, D, Finkelstein, A, Trillo, R, Fiorina, C, Walton, A, Malkin, CJ, Oh, JK, Qiao, H, Windecker, S, Grube, E, Windecker, S, Bosmans, J, Bleiziffer, S, Manoharan, G, Modine, T, Van Mieghem, N, Sinhal, A, Gooley, R, Walton, T, Yong, G, Bosmans, J, Webb, J, Chu, M, Radhakrishnan, S, Dager, A, Branny, M, Tchetche, D, Modine, T, Teiger, E, Chevalier, B, Himbert, D, Schymik, G, Zeus, T, Jensen, C, Rassaf, T, Fichtlscherer, S, Nickenig, G, Linke, A, Bleiziffer, S, Kempfert, J, Scholtz, W, Harnath, A, Strasser, R, Frerker, C, Spargias, K, Merkely, BP, Finkelstein, A, Tamburino, C, Colombo, A, Petronio, AS, Fiorina, C, Bedogni, F, Amoroso, G, van der Heijden, J, Van Mieghem, N, Tonino, P, Echeverria Beliz, P, Witkowski, A, Gama Ribeiro, V, Al Abdullah, M, Weich, H, Trillo, R, Hernández García, JM, Moris, C, Jönsson, AL, Malkin, CJ, Khogali, S, Hildick-Smith, D & Manoharan, G 2017, 'Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study', Journal of the American College of Cardiology, vol. 70, no. 7, pp. 845-853. https://doi.org/10.1016/j.jacc.2017.06.045
Grube, Eberhard ; Van Mieghem, Nicolas M. ; Bleiziffer, Sabine ; Modine, Thomas ; Bosmans, Johan ; Manoharan, Ganesh ; Linke, Axel ; Scholtz, Werner ; Tchétché, Didier ; Finkelstein, Ariel ; Trillo, Ramiro ; Fiorina, Claudia ; Walton, Antony ; Malkin, Christopher J. ; Oh, Jae Kuen ; Qiao, Hongyan ; Windecker, Stephan ; Grube, Eberhard ; Windecker, Stephan ; Bosmans, Johan ; Bleiziffer, Sabine ; Manoharan, Ganesh ; Modine, Thomas ; Van Mieghem, Nicolas ; Sinhal, Ajay ; Gooley, Robert ; Walton, Tony ; Yong, Gerald ; Bosmans, Johan ; Webb, John ; Chu, Michael ; Radhakrishnan, Sam ; Dager, Antonio ; Branny, Marian ; Tchetche, Didier ; Modine, Thomas ; Teiger, Emmanuel ; Chevalier, Bernard ; Himbert, Dominique ; Schymik, Gerhard ; Zeus, Tobias ; Jensen, Christoph ; Rassaf, Tienush ; Fichtlscherer, Stephan ; Nickenig, Georg ; Linke, Axel ; Bleiziffer, Sabine ; Kempfert, Jörg ; Scholtz, Werner ; Harnath, Axel ; Strasser, Ruth ; Frerker, Christian ; Spargias, Konstantinos ; Merkely, Béla Peter ; Finkelstein, Ariel ; Tamburino, Corrado ; Colombo, Antonio ; Petronio, Anna Sonia ; Fiorina, Claudia ; Bedogni, Francesco ; Amoroso, Giovanni ; van der Heijden, Jan ; Van Mieghem, Nicolas ; Tonino, Pim ; Echeverria Beliz, Pedro ; Witkowski, Adam ; Gama Ribeiro, Vasco ; Al Abdullah, Moheeb ; Weich, Hellmuth ; Trillo, Ramiro ; Hernández García, José Maria ; Moris, Cesar ; Jönsson, Anders Lars ; Malkin, Christopher J. ; Khogali, Saib ; Hildick-Smith, David ; Manoharan, Ganesh. / Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis : The International FORWARD Study. In: Journal of the American College of Cardiology. 2017 ; Vol. 70, No. 7. pp. 845-853.
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title = "Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study",
abstract = "Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9{\%} were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5{\%}, and 33.9{\%} of patients were deemed frail. The repositioning feature of the THV was applied in 25.8{\%} of patients. A single valve was implanted in the proper anatomic location in 98.9{\%} of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9{\%} at discharge. All-cause mortality was 1.9{\%}, and disabling stroke occurred in 1.8{\%} at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5{\%} of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)",
keywords = "aortic stenosis, degenerative valve, transcatheter aortic valve replacement",
author = "Eberhard Grube and {Van Mieghem}, {Nicolas M.} and Sabine Bleiziffer and Thomas Modine and Johan Bosmans and Ganesh Manoharan and Axel Linke and Werner Scholtz and Didier Tch{\'e}tch{\'e} and Ariel Finkelstein and Ramiro Trillo and Claudia Fiorina and Antony Walton and Malkin, {Christopher J.} and Oh, {Jae Kuen} and Hongyan Qiao and Stephan Windecker and Eberhard Grube and Stephan Windecker and Johan Bosmans and Sabine Bleiziffer and Ganesh Manoharan and Thomas Modine and {Van Mieghem}, Nicolas and Ajay Sinhal and Robert Gooley and Tony Walton and Gerald Yong and Johan Bosmans and John Webb and Michael Chu and Sam Radhakrishnan and Antonio Dager and Marian Branny and Didier Tchetche and Thomas Modine and Emmanuel Teiger and Bernard Chevalier and Dominique Himbert and Gerhard Schymik and Tobias Zeus and Christoph Jensen and Tienush Rassaf and Stephan Fichtlscherer and Georg Nickenig and Axel Linke and Sabine Bleiziffer and J{\"o}rg Kempfert and Werner Scholtz and Axel Harnath and Ruth Strasser and Christian Frerker and Konstantinos Spargias and Merkely, {B{\'e}la Peter} and Ariel Finkelstein and Corrado Tamburino and Antonio Colombo and Petronio, {Anna Sonia} and Claudia Fiorina and Francesco Bedogni and Giovanni Amoroso and {van der Heijden}, Jan and {Van Mieghem}, Nicolas and Pim Tonino and {Echeverria Beliz}, Pedro and Adam Witkowski and {Gama Ribeiro}, Vasco and {Al Abdullah}, Moheeb and Hellmuth Weich and Ramiro Trillo and {Hern{\'a}ndez Garc{\'i}a}, {Jos{\'e} Maria} and Cesar Moris and J{\"o}nsson, {Anders Lars} and Malkin, {Christopher J.} and Saib Khogali and David Hildick-Smith and Ganesh Manoharan",
year = "2017",
month = "8",
day = "15",
doi = "10.1016/j.jacc.2017.06.045",
language = "English (US)",
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pages = "845--853",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "7",

}

TY - JOUR

T1 - Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis

T2 - The International FORWARD Study

AU - Grube, Eberhard

AU - Van Mieghem, Nicolas M.

AU - Bleiziffer, Sabine

AU - Modine, Thomas

AU - Bosmans, Johan

AU - Manoharan, Ganesh

AU - Linke, Axel

AU - Scholtz, Werner

AU - Tchétché, Didier

AU - Finkelstein, Ariel

AU - Trillo, Ramiro

AU - Fiorina, Claudia

AU - Walton, Antony

AU - Malkin, Christopher J.

AU - Oh, Jae Kuen

AU - Qiao, Hongyan

AU - Windecker, Stephan

AU - Grube, Eberhard

AU - Windecker, Stephan

AU - Bosmans, Johan

AU - Bleiziffer, Sabine

AU - Manoharan, Ganesh

AU - Modine, Thomas

AU - Van Mieghem, Nicolas

AU - Sinhal, Ajay

AU - Gooley, Robert

AU - Walton, Tony

AU - Yong, Gerald

AU - Bosmans, Johan

AU - Webb, John

AU - Chu, Michael

AU - Radhakrishnan, Sam

AU - Dager, Antonio

AU - Branny, Marian

AU - Tchetche, Didier

AU - Modine, Thomas

AU - Teiger, Emmanuel

AU - Chevalier, Bernard

AU - Himbert, Dominique

AU - Schymik, Gerhard

AU - Zeus, Tobias

AU - Jensen, Christoph

AU - Rassaf, Tienush

AU - Fichtlscherer, Stephan

AU - Nickenig, Georg

AU - Linke, Axel

AU - Bleiziffer, Sabine

AU - Kempfert, Jörg

AU - Scholtz, Werner

AU - Harnath, Axel

AU - Strasser, Ruth

AU - Frerker, Christian

AU - Spargias, Konstantinos

AU - Merkely, Béla Peter

AU - Finkelstein, Ariel

AU - Tamburino, Corrado

AU - Colombo, Antonio

AU - Petronio, Anna Sonia

AU - Fiorina, Claudia

AU - Bedogni, Francesco

AU - Amoroso, Giovanni

AU - van der Heijden, Jan

AU - Van Mieghem, Nicolas

AU - Tonino, Pim

AU - Echeverria Beliz, Pedro

AU - Witkowski, Adam

AU - Gama Ribeiro, Vasco

AU - Al Abdullah, Moheeb

AU - Weich, Hellmuth

AU - Trillo, Ramiro

AU - Hernández García, José Maria

AU - Moris, Cesar

AU - Jönsson, Anders Lars

AU - Malkin, Christopher J.

AU - Khogali, Saib

AU - Hildick-Smith, David

AU - Manoharan, Ganesh

PY - 2017/8/15

Y1 - 2017/8/15

N2 - Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)

AB - Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)

KW - aortic stenosis

KW - degenerative valve

KW - transcatheter aortic valve replacement

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UR - http://www.scopus.com/inward/citedby.url?scp=85025833603&partnerID=8YFLogxK

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DO - 10.1016/j.jacc.2017.06.045

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VL - 70

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JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

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