Expert Review of Medical Devices
ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: http://www.tandfonline.com/loi/ierd20
Evaluation of The Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis Nay M Htun & John G Webb To cite this article: Nay M Htun & John G Webb (2016): Evaluation of The Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis, Expert Review of Medical Devices, DOI: 10.1586/17434440.2016.1149288 To link to this article: http://dx.doi.org/10.1586/17434440.2016.1149288
Accepted author version posted online: 15 Feb 2016.
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Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierd20 Download by: [Ryerson University Library]
Date: 17 February 2016, At: 06:42
Publisher: Taylor & Francis Journal: Expert Review of Medical Devices DOI: 10.1586/17434440.2016.1149288 The Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis
Nay M Htun, John G Webb
Downloaded by [Ryerson University Library] at 06:42 17 February 2016
Corresponding author: Dr John G Webb, St Paul’s Hospital, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada; Phone: +1 604 806 8804; Email: [email protected].
(Both authors are from the same hospital)
Summary Transcatheter aortic valve replacement is a viable alternative to surgical aortic valve replacement in patients with severe aortic stenosis. The SAPIEN 3 is the latest generation of balloon-expandable transcatheter heart valve, designed to address some of the shortcomings of earlier versions of transcatheter heart valves. It has a lower device profile to reduce access-related vascular injury, an improved delivery catheter to facilitate accurate implantation, and incorporates an additional outer sealing cuff to minimise paravalvular leakage. The latest European and North American trials using SAPIEN 3 have documented very low rates of vascular complications and paravalvular regurgitation with rates of stroke and mortality rates lower than anticipated with SAVR in both intermediate and high surgical risk patients.
Keywords Transcatheter aortic valve replacement, Aortic stenosis, Balloon-expandable aortic valve prosthesis, Edwards SAPIEN 3, Transcatheter heart valve
1. Introduction Aortic stenosis is the most common valvular heart disease in the Western world. Traditionally surgical aortic valve replacement (SAVR) was the gold standard treatment for severe aortic stenosis (AS) leading to the improvement in symptoms as well as survival. Without surgery, the prognosis of symptomatic severe AS is poor with a reported overall 3-year survival rate of 21% (1). However aortic valve surgery is frequently denied despite symptomatic severe AS due to age, left ventricular dysfunction and comorbidities (2). No other options except palliative medical therapy were available until transcatheter aortic valve replacement (TAVR) was introduced recently as a viable alternative. 2.Transcatheter Aortic Valve Replacement (TAVR)
Downloaded by [Ryerson University Library] at 06:42 17 February 2016
First-in-man percutaneous TAVR was described in 2002, followed by several refinements in the technology. Subsequently a number of landmark trials paved the way for TAVR to become a wellestablished treatment for AS. The Placement of AoRTic TraNscathetER Valves (PARTNER) Trials were the first prospective randomized studies examining the role of TAVR for aortic stenosis (as well of medical management and SAVR). PARTNER IA compared TAVR using the earlier-generation balloon-expandable Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA) with SAVR in patients with symptomatic severe AS at high surgical risk (3). At 30 days all-cause mortality was similar for TAVR and SAVR. Major stroke rates were more common with TAVR than SAVR, although this was not statistically significant (5.1% versus 2.4%, p=0.07) and stroke assessments were somewhat limited. Major vascular complications were significantly more frequent in TAVR group (11% versus 3.2%, p
ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: http://www.tandfonline.com/loi/ierd20
Evaluation of The Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis Nay M Htun & John G Webb To cite this article: Nay M Htun & John G Webb (2016): Evaluation of The Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis, Expert Review of Medical Devices, DOI: 10.1586/17434440.2016.1149288 To link to this article: http://dx.doi.org/10.1586/17434440.2016.1149288
Accepted author version posted online: 15 Feb 2016.
Submit your article to this journal
View related articles
View Crossmark data
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierd20 Download by: [Ryerson University Library]
Date: 17 February 2016, At: 06:42
Publisher: Taylor & Francis Journal: Expert Review of Medical Devices DOI: 10.1586/17434440.2016.1149288 The Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis
Nay M Htun, John G Webb
Downloaded by [Ryerson University Library] at 06:42 17 February 2016
Corresponding author: Dr John G Webb, St Paul’s Hospital, 1081 Burrard St, Vancouver, BC, V6Z 1Y6, Canada; Phone: +1 604 806 8804; Email: [email protected].
(Both authors are from the same hospital)
Summary Transcatheter aortic valve replacement is a viable alternative to surgical aortic valve replacement in patients with severe aortic stenosis. The SAPIEN 3 is the latest generation of balloon-expandable transcatheter heart valve, designed to address some of the shortcomings of earlier versions of transcatheter heart valves. It has a lower device profile to reduce access-related vascular injury, an improved delivery catheter to facilitate accurate implantation, and incorporates an additional outer sealing cuff to minimise paravalvular leakage. The latest European and North American trials using SAPIEN 3 have documented very low rates of vascular complications and paravalvular regurgitation with rates of stroke and mortality rates lower than anticipated with SAVR in both intermediate and high surgical risk patients.
Keywords Transcatheter aortic valve replacement, Aortic stenosis, Balloon-expandable aortic valve prosthesis, Edwards SAPIEN 3, Transcatheter heart valve
1. Introduction Aortic stenosis is the most common valvular heart disease in the Western world. Traditionally surgical aortic valve replacement (SAVR) was the gold standard treatment for severe aortic stenosis (AS) leading to the improvement in symptoms as well as survival. Without surgery, the prognosis of symptomatic severe AS is poor with a reported overall 3-year survival rate of 21% (1). However aortic valve surgery is frequently denied despite symptomatic severe AS due to age, left ventricular dysfunction and comorbidities (2). No other options except palliative medical therapy were available until transcatheter aortic valve replacement (TAVR) was introduced recently as a viable alternative. 2.Transcatheter Aortic Valve Replacement (TAVR)
Downloaded by [Ryerson University Library] at 06:42 17 February 2016
First-in-man percutaneous TAVR was described in 2002, followed by several refinements in the technology. Subsequently a number of landmark trials paved the way for TAVR to become a wellestablished treatment for AS. The Placement of AoRTic TraNscathetER Valves (PARTNER) Trials were the first prospective randomized studies examining the role of TAVR for aortic stenosis (as well of medical management and SAVR). PARTNER IA compared TAVR using the earlier-generation balloon-expandable Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA) with SAVR in patients with symptomatic severe AS at high surgical risk (3). At 30 days all-cause mortality was similar for TAVR and SAVR. Major stroke rates were more common with TAVR than SAVR, although this was not statistically significant (5.1% versus 2.4%, p=0.07) and stroke assessments were somewhat limited. Major vascular complications were significantly more frequent in TAVR group (11% versus 3.2%, p
