Edwards SAPIEN 3 Ultra TAVI

Bicuspid Treatment Options

Edwards SAPIEN 3 Ultra TAVI

Bicuspid Treatment Options

Bicuspid aortic valve disease is the most common congenital heart defect in adults1

Graphic: on the left, a gray globe (Africa–Europe) inside a circle. On the right, six simplified person icons in a row on white: figures 1 and 4 are red; the other four are gray. Three figures use a dress-shaped silhouette and three use a straight-leg silhouette.
0.9–2%

worldwide population1

1 in 3

develop major complications, including aortic stenosis and regurgitation2

Congenital bicuspid aortic valve disease is more prevalent in younger patients requiring AVR3

Infographic. Left: arrow label 'TAVI value and optimisation' with the text 'planning is crucial for bicuspid patients.' Right: 100% stacked bar chart titled 'Aortic Valve Replacement by Valve Type.' Y-axis label: 'Percentage of patients' (0–100%). X-axis label: 'Age' with groups: '21–50 (n=116)', '51–79 (n=1239)', '80–89 (n=347)', '>90 (n=17)'. Legend: 'Tricuspid' (light gray), 'Bicuspid' (red), 'Unicuspid' (dark gray). Values printed in the bars: '54%' bicuspid for ages 21–50, '51%' bicuspid for 51–79, '22%' bicuspid for 80–89, and '18%' bicuspid for >90.

1. Sievers HH. et al. A classification system for the bicuspid aortic valve from 304 surgical specimens. J Thorac Cardiovasc Surg. 2007 May;133(5):1226-33. / 2. Jermihov PN. et al. Effect of Geometry on the Leaflet Stresses in Simulated Models of Congenital Bicuspid Aortic Valves. Cardiovasc Eng Technol. 2011 Mar;2(1):48-56. / 3. Roberts WC. et al. Frequency of congenitally bicuspid aortic valves in patients ≥ 80 years of age undergoing aortic valve replacement for aortic stenosis (with or without aortic regurgitation) and implications for transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 1;109(11):1632-6.

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Bicuspid valve morphology

Historically, pivotal randomized trials excluded bicuspid patients due to perceived anatomical challenges for TAVI1

Infographic titled 'Prevalence of Bicuspid Morphological Variations²'. Total number of patients: 304. Three schematic aortic valve views with labels and percentages: 'Type 0 — 7%', 'Type 1 — 88%', 'Type 2 — 5%'. Bottom banner text: 'Bicuspid aortic valves comprise a wide variety of morphological variations²'.

1. Das R. et al. Transcatheter Treatment of Bicuspid Aortic Valve Disease: Imaging and Interventional Considerations. Front Cardiovasc Med. 2018 Jul 19;5:91. / 2. Sievers HH. et al. A classification system for the bicuspid aortic valve from 304 surgical specimens. J Thorac Cardiovasc Surg. 2007 May;133(5):1226-33.

The Heart Team needs to evaluate several factors that can impact therapy selection1

Infographic of a Heart Team. Center: 'Your Patient.' Around the patient in a circle (clockwise from top): Interventional Cardiologist, Nurse, Referring Cardiologist, Imaging Specialist, Cardiac Cath Lab & O.R. Staff, Valve Clinic Coordinator, Cardiothoracic Surgeon, Anesthesiologist. Right-side text: 'Several factors can impact bicuspid therapy selection, including: – Fragility of the aortic wall – Dimensions of the annulus – Raphe – Calcification levels – Age.' Additional note: 'A segment of bicuspid patients may be better suited for surgery.'

1. Anwaruddin S. et al. Systematic Approach Toward Transcatheter Treatment of BAV Disease: One Size Does Not Fit All. J Am Coll Cardiol. 2020 Sep 1;76(9):1031-1033.Anwaruddin S. et al. Systematic Approach Toward Transcatheter Treatment of BAV Disease: One Size Does Not Fit All. J Am Coll Cardiol. 2020 Sep 1;76(9):1031-1033.

The SAPIEN 3 valve platform has been studied across all surgical risk classes in several international registries

Infographic. Left: red circle reads '4000+ bicuspid patients treated with the SAPIEN 3 valve¹' above a photo of the SAPIEN 3 valve. Main heading: 'The most frequently used device across several international registries.' Four panels list registry data: (1) 'STS/ACC TVT Registry' — 'S. Halim²' — 'n = 5,412' — 'STS = 3.8%' — '73% SAPIEN 3 valve.' (2) 'Low Risk TAVR Bicuspid Cohort Study' — 'R. Waksman³' — 'n = 61' — 'STS = 1.5%' — '74% SAPIEN 3 valve' (with LRT logo). (3) 'BAV TAVR International Registry' — 'SH. Yoon⁴' — 'n = 1,034' — 'STS = 3.7%' — '72% SAPIEN 3 valve.' (4) 'BAVARD Multicenter Registry' — 'D. Tchétché⁵' — 'n = 101' — 'STS = 11.3%' — '65% SAPIEN 3 valve.'

1. STS/ACC TVT Registry, Data on File at Edwards Lifesciences. / 2. Kim SA. et al. Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Disease: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation. 2020 Mar 31;141(13):1071-1079. / 3. Waksman R. et al. Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis. JACC Cardiovasc Interv. 2020 May 11;13(9):1019-1027. / 4. Yoon SH. et al. Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators. Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Sep 1;76(9):1018-1030. / 5. Tchetche D. et al. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107.

Recent publications have however demonstrated that TAVI can be a safe and effective alternative to surgery1

Infographic comparing outcomes for bicuspid vs tricuspid patients treated with SAPIEN 3 TAVI. Left gray arrow text: 'In selected bicuspid patients SAPIEN 3 TAVI achieves outcomes similar to tricuspid patients' above a photo of the SAPIEN 3 valve. Right: 'TVT-Registry — Matched cohort' table with columns Bicuspid and Tricuspid: 'Median Age (years) 74 vs 74'; 'Mean STS Score (%) 4.9 vs 5.1'. Kaplan–Meier chart with legend (gray=Bicuspid, red=Tricuspid), y-axis 'All-cause mortality or stroke (%)', x-axis 'Time in months'. Twelve-month rates: Tricuspid 14.1%, Bicuspid 12.9%. Statistics: 'HR: 0.97 [95% CI: 0.81 to 1.16] P=0.74'. Number at risk (months 0, 3, 6, 9, 12): Bicuspid 2691, 1234, 1196, 1135, 910; Tricuspid 2691, 1341, 1296, 1226, 952.

1. Makkar RR. et al. Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke. JAMA. 2019 Jun 11;321(22):2193-2202.

The SAPIEN 3 valve platform demonstrates excellent PVL performance in bicuspid patients

On a white background: heading 'Achieve outstanding PVL performance with:' and two bullets 'High radial strength' and 'Sealing skirt technology.' Center: product photo of the SAPIEN 3 valve. Right panel titled 'Paravalvular leak (PVL) at 1-year' with a 0–100% scale and legend (red = None/Trace, gray = Mild, dark red = ≥ Moderate). Results — TVT-Registry (n=593)¹: 75.7% None/Trace, 21.1% Mild, 3.2% ≥ Moderate. PARTNER 3 trial low surgical risk bicuspid nested registry (n=67)²: 73.1% None/Trace, 26.9% Mild, 0.0% ≥ Moderate. Note: '19.7% Post-Dilatation (n=71)².'

1. Makkar R. et al. Outcomes of Transcatheter Aortic Valve Replacement with Balloon Expandable Sapien3 Valve in Bicuspid Aortic Stenosis:; Presented at ACC 2019, New Orleans, USA.
2. Williams M. et al. The PARTNER 3 Bicuspid Registry for SAPIEN 3 TAVR in Low Surgical Risk Patients; Presented at TCT 2020; October 2020, tctconnect.com

At the time of the first implant, several factors need to be considered

Infographic. Red header: ‘Bicuspid patients with longer life expectancies require additional considerations for TAVI procedures.’ Three panels beneath with images and captions: (1) Top-down view of a valve — ‘Circularity in elliptical bicuspid valves¹.’ (2) SAPIEN 3 transcatheter valve — ‘Secondary interventions will be more common in patients with longer life expectancies².’ (3) Anatomical illustration near the aortic root with a catheter — ‘Future coronary interventions may be required³.’

1. Tchetche D. et al. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. / 2. Pasala TKR. et al. Transcatheter Aortic Valve Replacement for All-comers With Severe Aortic Stenosis: Could It Become a Reality?. Rev Esp Cardiol (Engl Ed). 2018;71(3):141-145. / 3. Yudi MB, et al. Coronary Angiography and percutaneous coronary intervention after transcatheter aortic valve replacement. JACC Vol 71, No 12, 2018.

Circularity is the hallmark of the SAPIEN 3 valve design

Left: top-down image of a circular transcatheter valve ring with red arrows around it and the caption: ‘Optimal circularity promotes consistent leaflet function and coaptation¹.’ Center: grey callout—‘The SAPIEN 3 valve maintains excellent circularity in bicuspid patients².’ Right: bar chart labeled at the bottom ‘SAPIEN 3 (n=84)’ with y-axis ticks 1.00–1.40. Two bars: red ‘1.09’ (legend: ‘Tricuspid (n=19)’) and grey ‘1.12’ (legend: ‘Bicuspid (n=65)’). Small schematic of an aortic valve above the chart. Superscripts ¹ and ² indicate literature references.

1. Binder RK et al. Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve. JACC Cardiovasc Interv. 2013 Mar;6(3):293-300.
2. Tchetche D. et al. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107.

The need for post-TAVI coronary access is expected to increase in patients with longer life expectancies

Illustration and data table about coronary access after TAVI. Left: line drawing of the aortic root with a transcatheter valve in place; a red arrowed path shows a catheter coursing from the aorta into a coronary artery. Right: comparison table with two columns — ‘TVT-Registry¹ (n=2691)’ and ‘PARTNER 3 trial low surgical risk bicuspid nested registry² (n=71)’. Rows: ‘Median Age (years): 74 | 68.5’; ‘Mean STS Score (%): 4.9 | 1.4’; ‘Coronary Disease (%): NR* | 9.9’; ‘Prior Coronary Stenting (%): 25.5 | NR*’; ‘Prior Coronary Bypass Graft Surgery (%): 15.9 | 0.0’; ‘Prior CAD Intervention (%): 41.4 | 9.9’. (*NR = Not Reported.)

* Not Reported / 1. Makkar RR. et al. Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke. JAMA. 2019 Jun 11;321(22):2193-2202. / 2. Williams M. et al. The PARTNER 3 Bicuspid Registry for SAPIEN 3 TAVR in Low Surgical Risk Patients; Presented at TCT 2020; October 2020, tctconnect.com / 3. Image adapted from Sondergaard L., De Backer O. (2018). Transcatheter aortic valve implantation: don’t forget the coronaries! EuroInterv, 14(2), 147-9.

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Recorded sessions

TAVI in Bicuspid Aortic Valve patients: SAPIEN 3 platform, a safe and efficient option

Speakers: R. Parma, J. Kempfert, D. Blackman, B. Garcia del Blanco

TAVI in Bicuspid Aortic Valve patients. SAPIEN 3 platform, a safe and efficient option

Moderated by Philippe Généreux. Speakers: J. Kempfert, R. Parma, D. Tchétché

TAVI in Bicuspid Aortic Valves

Speakers: D. Blackman, S. Doshi

SAPIEN 3 Ultra in in Bicuspid Aortic Valve Type 0

Deutsches Herzzentrum – Berlin

Performed by: J. Kempfert, C. Klein

Introduced by: A. Unbehaun

SAPIEN 3 Ultra in Bicuspid Aortic Valve Type 1

Deutsches Herzzentrum – Berlin

Performed by: J. Kempfert, C. Klein

Introduced by: A. Unbehaun

Bicuspid aortic valve case presentation – part 1

Presented by: Dr. Didier Tchetche, Dr. Nicolas Dumonteil

Bicuspid aortic valve case presentation – part 2

Presented by: Dr. Didier Tchetche, Dr. Nicolas Dumonteiln

Performed by: J. Kempfert, C. Klein

Introduced by: A. Unbehaun

Interview with J. Kempfert

Deutsches Herzzentrum – Berlin

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Publications

Featuring the latest cardiology news, clinical trials and real-world evidence in aortic stenosis (AS) management.

Panel discussions

Involving leading cardiologists debating the latest topics in transcatheter aortic valve implantation (TAVI) and AS management.

Conference headlines

Providing insights into the major developments from the latest cardiology events.

Guidelines updates

Highlighting the areas of change within any updated aortic stenosis treatment guidelines.

No clinical data are available to evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.

Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

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