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Aortic Stenosis

The Burden of Aortic Stenosis2-7


 

Some of the more commonly experienced symptoms include:8


 

Fatigue

Inability to exercise

Fainting

Shortness of breath

Chest pain

Heart palpitations

Presence of a heart murmur

Due to the often slow, progressive nature of Aortic Stenosis, patients may not recognise the symptoms because their daily activity levels may have only gradually reduced over time.9 Most patients are first diagnosed when a systolic murmur is detected.8,9


 

Aortic Stenosis has a high risk of mortality after the onset of symptoms10


 


 

Is there an option for those with Aortic Stenosis?


Transcatheter aortic valve implantation (TAVI) is a minimally invasive option for patients with aortic valve stenosis.11 The Navitor™ TAVI System is indicated for transcatheter delivery in patients with symptomatic severe aortic stenosis who are considered high surgical risk.11


 

References

1. Sondergaard, L. 30-day outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR conference; May 18-20, 2021.

2. Bouma B J, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart. 1999;82:143-148.

3. Iung, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal. 2003;24:1231-1243.

4. Pellikka PA, et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation. 2005;111:3290–3295.

5. Charlson E, et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis 2006;15:312-321.

6. Osnabrugge RLJ, et al. Aortic Stenosis in the Elderly: Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study. J AM Coll Cardiol. 2013;62(11):1002-12.

7. Capoulade R, et al. Assessment of aortic valve disease: role of imaging modalities. Curr Treat Options Cardio Med. 2015;17:49.

8. Ren X. Aortic stenosis. MedScape. https://emedicine.medscape.com/article/150638-overview. Published March 23, 2017.

9. Nishimura RA, et al. 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2014;129(23):2440-2492.

10. Kanwar A, et al. Management of Patients with Aortic Valve Stenosis. Mayo Clinic Proceedings. 2018;93:4:488-505.

11. Navitor™ TAVI System Instructions for Use. 

Why Choose Navitor™ with FlexNav™ Transcatheter Aortic Valve Implantation (TAVI) System?1,2

Navitor™ with FlexNav™ TAVI system offers intelligent design advantages, including smart PVL-sealing NaviSeal™ Cuff, stable and accurate placement, desirable single-digit gradients,2 and uncompromised small vessel access and coronary access to consistently achieve favourable outcomes across a spectrum of routine to challenging anatomies.2


 

Discover the Navitor™ with FlexNav™ TAVI System Features and Benefits2-8

 Intelligent Design2,3


 

See tab 3 for data on Navitor™ with FlexNav™ TAVI System smart sealing and haemodynamics

The Navitor™ Valve Sizes:9

Valve SizeANNULUS USE RANGE DIAMETER (mm)ANNULUS AREA (mm2)ANNULUS PERIMETER (mm)
23 mm19-21277-34660-66
25 mm21-23338-41566-73
26 mm23-25405-49172-79
29 mm25-27479-57379-85


 


 


*The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual’s experience and might not be representative of others.

References

1. Sondergaard, L. 30-day outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR conference; May 18-20, 2021.

2. Smith, D. One-year clinical trial results with a next-generation aortic transcatheter heart valve. Presented at: EuroPCR conference; May 17-20, 2022.

3. Pibarot P, et al. Assessment of paravalvular regurgitation following TAVR: a proposal of unifying grading scheme. JACC Cardiovasc Imaging. 2015;8(3):340-360.

4. Frater RWM, et al. Advances in anticalcific and antidegenerative treatment of heart valve bioprostheses. Silent Partners Inc. 1997;8:105-13.

5. Kelly SJ, et al. Biocompatibility and calcification of bioprosthetic heart valves. Society for biomaterials. Sixth World Biomaterials Congress Transaction. 2000;13534.

6. Vyavahare N, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation: efficacy and mechanisms. Circulation. 1997;95(2):479-88.

7. Vyavahare N, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation: mechanistic studies of protein structure and water-biomaterial relationships. J Biomed Mater Res. 1998;40(4):577-85.

8. Data on file at Abbott. 90664679.

9. Data on file at Abbott. 90734545/90465559.

Discover FlexNav™ for Navitor™ TAVI System

Recapturable*, Repositionable*, and Retrievable* Design.2,3

*Until fully deployed.

Enhanced Flexibility.2,4,5


FlexNavTM Delivery System offers 3D-flexibility at the distal end and throughout its entire working length. 

Uncompromised Small Vessel Access

Low profile (5.0 mm) minimum vessel diameter with a highly flexible catheter enables small vessel access and excellent deliverability, even in patients with tortuous anatomies.

The Navitor™ FlexNav™ TAVI System Sizes:5-10

 Navitor™ with FlexNav™5EVOLUT‡ Pro
with ENVEO‡ Pro6		SAPIEN‡3
with eSHEATH‡7,8		ACURATE NEO2‡
with iSLEEVE‡9,10
Delivery System Profile (Outer Diameter)6.0 mm
6.3 mm		6.7 mm7.6 mm
8.2 mm		6.0 mm
Minimum Vessel Diameter5.0 mm
5.5 mm		5.5 mm5.5 mm
6.0 mm		5.5 mm


‡Indicates a third-party trademark, which is property of its respective owner.

References

1. Sondergaard, L. 30-day outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR conference; May 18-20, 2021.

2. Supplement to Cardiac Interventions Today Europe. Vol 4(1) 2020.

3. Fontana GP, et al. Safety profile of an intra-annular self-expanding transcatheter aortic valve and next-generation low-profile delivery system. JACC Cardiovasc Interv. 2020;13:2467-2478.

4. Abbott data on file 90346620.

5. Navitor™ TAVI System Instructions for Use.

6. Medtronic CoreValve Evolut‡‚ PRO Instructions for Use.

7. Edwards Sapien 3‡ Instructions for Use.

8. Koehler Sapien 3‡ eSheath‡ OD BMRI 2015.

9. Boston Scientific Acurate neo2‡ Instructions for Use.

10. Boston Scientific iSleeve‡ Instructions for Use.

 

Navitor™ with FlexNav™ TAVI System: The Clinical Evidence

Clinical results demonstrate excellent outcomes across a spectrum of routine to challenging anatomies.2

30-DAY Clinical Outcomes2

0%

Moderate or Severe PVL

0%

All-Cause Mortality

0.8%

Disabling Stroke

0.8%

Major Vascular Complications††

7.4

mmHg Mean Gradient

1-YEAR Clinical Outcomes2

1.0%

Moderate PVL
(0% Severe PVL)

4.2%

All-Cause Mortality

0.8%

Disabling Stroke

0.8%

Major Vascular Complications

7.5

mmHg Mean Gradient

Compare the 30-day clinical outcomes with other devices

30-DayNavitor™2
N=120 		EVOLUT‡ Pro3
N=60		SAPIEN‡ 34
N=96*		ACURATE NEO2‡ 5
N=120
All-Cause Mortality0.0%1.7%2.1%3.3%
Disabling Stroke0.8%1.7%0.0%1.7%
Life-Threatening Bleeding 2.5%11.7%3.1%5.0%
Acute Kidney Injury Stage 2/3 1.7%1.7%1.0%0.8%
Major Vascular Complications 0.8%††10.0%4.2%3.3%
Naive Pacemaker Implantation15.0%11.8%14.5%16.1%

Compare the 1-year clinical outcomes with other devices

1-YearNavitor™2
N=120 		EVOLUT‡ Pro6
N=60		SAPIEN‡ 37
N=96*		ACURATE NEO2‡5
N=120
All-Cause Mortality4.2%11.8%8.4%11.9%
Disabling Stroke0.8%1.7%1.1%1.7%
Life-Threatening Bleeding 5.0%NRNR8.5%
Acute Kidney Injury Stage 2/3 1.7%NRNR0.8%
Major Vascular Complications 0.8%NRNR3.3%
Naive Pacemaker Implantation16.8%**15.9%15.7%18.8%

NR = No response.

NOTE: Data not from head-to-head studies. Data provided for informational purposes only. Referenced data reflect results from prospective, multicentre clinical studies with contemporary valves in high and extreme risk surgical patients conducted to support CE Mark approval.

* Transfemoral access cohort.

†† CEC adjudicated as related to procedure but not to device.

** Of the 18 subjects who required new PPI through 1 year, 13 had pre-existing conduction abnormalities.

‡ Indicates a third-party trademark, which is property of its respective owner. 

SMART SEALING MITIGATES PARAVALVULAR LEAK (PVL)

30-day and 1-year Echo Core Lab Data:2-7

30-DAYS2

79.7%

None/Trace

20.3%

Mild

0%

Moderate

0%

Severe

1-YEAR2

70.2%

None/Trace

28.8%

Mild

1%

Moderate

0%

Severe

30-DAYS

PVL 30-DAY ECHO CORE LAB DATANavitor™2
N=118 		EVOLUT‡ Pro3
N=58		SAPIEN‡ 34
N=113*		ACURATE NEO2‡5
N=100
None/Trace79.7%72.4%74.3%35.0%
Mild20.3%27.6%22.1%62.0%
Moderate0.0%0.0%3.5%3.0%
Severe0.0%0.0%0.0%0.0%

1-YEAR

PVL 1-YEAR ECHO CORE LAB DATANavitor™2
N=104 		EVOLUT‡ Pro6
N=46		SAPIEN‡ 37
N=100*		ACURATE NEO2‡5
N=81
None/Trace70.2%89.1%84.0%60.5%
Mild28.8%10.9%14.0%37.0%
Moderate1.0%0.0%2.0%2.5%
Severe0.0%0.0%0.0%0.0%

Based on number of subjects with data evaluable by the echo core lab.

NOTE: Data not from head-to-head studies. Data provided for informational purposes only. Referenced data reflect results from prospective, multicentre clinical studies with contemporary valves in high and extreme risk surgical patients conducted to support CE Mark approval.

* Includes data on subjects implanted via transapical and transaortic access.

‡ Indicates a third-party trademark, which is property of its respective owner. 

HAEMODYNAMIC IMPACT

Non-tapered stent and large effective orifice areas (EOAs) resulting in single-digit gradients are associated with improved cardiac function, long-term durability, and minimal prosthesis-patient mismatch.2

Compare Haemodynamics with Other Devices1-7

30-DAYS

30-DAY ECHO CORE LAB DATANavitor™1
EVOLUT‡ Pro6
SAPIEN‡ 34
ACURATE NEO2‡5
Mean Gradient (mmHg)7.4
(N=118)		6.4
(N=55)		10.6
(N=119*)		7.9
(N=104)
EOA (cm2)2.0
(N=101)		2.0
(N=47)		1.5
(N=97*)		1.7
(N=99)

1-YEAR

1-YEAR ECHO CORE LAB DATANavitor™2
EVOLUT‡ Pro6
SAPIEN‡ 37
ACURATE NEO2‡5
Mean Gradient (mmHg)7.5
(N=107)		7.1
(N=44)		10.9†
(N=86)		7.6
(N=85)
EOA (cm2)1.9
(N=88)		2.0
(N=40)		1.5†
(N=64)		1.7
(N=77)

Based on number of subjects with data evaluable by the echo core lab.

NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

NOTE: Reference data reflects results from prospective, multicentre clinical studies with contemporary valves in high- and extreme-risk surgical patients conducted in support of CE Mark approval (except Sapien‡ 3 study cohort includes mixed high and intermediate risk patients).

* Includes data on subjects implanted via transapical and transaortic access.

† Paired Analysis

‡ Indicates a third-party trademark, which is property of its respective owner. 

References

1. Sondergaard, L. 30-day outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR conference; May 18-20, 2021.

2. Smith, D. One-year clinical trial results with a next-generation aortic transcatheter heart valve. Presented at: EuroPCR conference; May 17-20, 2022.

3. Forrest JK, et al. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap. J Am Coll Cardiol Intv. 2018;11:160-168.

4. Webb J, et al. Multicentre evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-43.

5. Möllmann H, et al. The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes. Clin Res Cardiol. 2021 Dec;110(12):1912-1920.

6. Wyler von Ballmoos MC, et al. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovasc Revasc Med. 2021 May;26:12-16.

7. Webb, J. 1-year outcomes from the Sapien 3 Trial. Presented at: EuroPCR conference; May 19-22, 2015.

 

The Referral Process


 

Watch the Navitor™ with FlexNav™ TAVI System in Action

Abbreviations and References

Abbreviations: ECHO, echocardiogram.

1. Sondergaard, L. 30-day outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR conference; May 18-20, 2021.

2. Benjamin EJ, et al. Heart disease and stroke statistics—2017 update: A report from the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603.

3. Strange G, et al. Poor Long-Term Survival in Patients With Moderate Aortic Stenosis. Journal of the American College of Cardiology. 2019;74:15.


 


 

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