Transcatheter heart valves for transcatheter aortic valve implantation to treat aortic stenosis: late-stage assessment

Ten transcatheter heart valves were available on the NHS Supply Chain and included in this assessment at the time of publication. All of them had valid CE certification as class 3 implantable devices. The ACURATE neo2 transcatheter heart valve (Boston Scientific) was removed from this late-stage assessment because it is no longer available in the NHS.

Allegra is a self-expanding transcatheter heart valve made from bovine pericardial tissue. It is positioned supra-annularly and is available in 3 sizes: 23 mm, 27 mm and 31 mm. It is indicated for:

• severe calcified aortic valve stenosis in people at high surgical risk

• treating severe calcified aortic valve stenosis in people with symptomatic degeneration of an aortic valve bioprosthesis.

Evolut R, Evolut Pro+ and Evolut FX are self-expanding transcatheter heart valves made from porcine pericardial tissue. They are positioned supra-annularly and are available in 4 sizes: 23 mm, 26 mm, 29 mm and 34 mm. The valves are indicated for severe native aortic valve stenosis. In severe native bicuspid aortic valve stenosis, the valves are indicated for

• people at intermediate or greater risk for surgical aortic valve replacement (SAVR), or

• when there is a documented heart-team agreement of risk for SAVR because of frailty or comorbidities.
  
  Intermediate risk is defined as the Society of Thoracic Surgeons (STS) operative risk score of 4% and above. For people presenting at low risk for SAVR (less than 4%), the valves are indicated for people 70 years and over with a left ventricular ejection fraction above 30%. The valves are also indicated for people with a stenosed, insufficient, or combined bioprosthetic valve failure needing valve replacement:

• who are at high or greater risk for SAVR, or

• when there is a documented heart-team agreement of risk for SAVR because of frailty or comorbidities.
  
  High risk is defined as an STS operative risk score of 8% and above. All valves are indicated for surgical bioprosthetic valve replacement, and the Pro+ and FX are also indicated for transcatheter bioprosthetic valve replacement.
  
  Compared with the Evolut R, the Evolut Pro+ has an additional external pericardial wrap and an updated delivery system. Compared with the Evolut Pro+, the Evolut FX has additional gold markers to visualise implant depth and coronary alignment, and an updated delivery system. There have been no changes to the valve housing or leaflets as the design has progressed from Evolut R to Evolut FX.

Hydra is a self-expanding transcatheter heart valve made from bovine pericardial tissue. It is positioned supra-annularly and is available in 3 sizes: 22 mm, 26 mm and 30 mm. It is indicated for severe degenerative aortic stenosis in people with a high predictable operative mortality risk for SAVR. The decision is based on the clinical judgement of the heart team.

Myval Octacor is a balloon-expanding transcatheter heart valve made from bovine pericardial tissue. It is positioned intra-annularly and is available in 9 sizes between 20 mm and 32 mm. Myval Octacor is indicated for aortic stenosis in people with symptomatic heart disease because of severe native calcific aortic stenosis as judged by a heart team, including a cardiac surgeon. It is also indicated for people who have a risk for open heart surgery (an STS operative risk score of 4% and above risk of mortality at 30 days).

Navitor is a self-expanding transcatheter heart valve made from bovine pericardial tissue. It is the only self-expanding valve with intra-annular leaflets. Navitor is available in 4 sizes: 23 mm, 25 mm, 27 mm and 29 mm. It is indicated for symptomatic severe native aortic stenosis in people who are considered to have a high or extreme risk for SAVR.

Sapien 3 and Sapien 3 Ultra are balloon-expanding transcatheter heart valves made from bovine pericardial tissue. They are positioned intra-annularly and are available in 20 mm, 23 mm and 26 mm sizes. Sapien 3 is also available in a 29 mm size. The valves are indicated for heart disease because of native calcific aortic stenosis in people at any or all levels of surgical risk. They are also indicated for symptomatic heart disease caused by failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or a surgical bioprosthetic aortic valve when a heart team, including a cardiac surgeon, considers the person to be at high or greater risk for open surgical treatments. High or greater risk is defined as a predicted risk of surgical mortality of 8% and above at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator. Compared with the Sapien 3, the Sapien 3 Ultra has an augmented outer skirt.

Trilogy is a self-expanding transcatheter heart valve made from porcine pericardial tissue. It is positioned supra-annularly and is available in 3 sizes: 23 mm, 25 mm and 27 mm. Trilogy is indicated for native symptomatic, severe aortic regurgitation or symptomatic, severe aortic stenosis in people who a heart team, including a cardiac surgeon, considers to have high or greater risk for SAVR. High or greater risk is defined as a predicted risk of surgical mortality of 8% and above at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator.