Tricuspid Regurgitation (TR)

The Burden of TR in Australia2

According to the Australian National Database ECHO study:


 

Australian National Database: ECHO Study

Patients with moderate or greater TR have impaired quality of life


Some of the more common symptoms of TR are: 
 

Shortness of breath

Peripheral oedema

Ascites

Fatigue

Declining exercise capacity

Left untreated, TR may lead to right heart failure and eventually death3


 

TR is Highly Prevalent and Undertreated4-8


 

*Calculations are approximations made based on data from Mills J, Furlong C. CANACCORD: Biomedical Devices and Services. Nov 8, 2016 and Millennium Research Group. US Markets for Heart Valve Devices 2014. 2013; RPUS12HV13:92; and data from Abbott (LRP 20161130; based on LBE4). 


 

Current Treatment Options are Sub-Optimal

For many patients with TR, medical management is not enough.9

Surgery is high-risk and often denied.4


 

Medical therapies only work to manage symptoms and have a limited impact on survival. 66% of patients with severe functional tricuspid regurgitation (FTR) die within 5 years of medical management.9

Additionally, surgery for TR is seldom performed. Factors prohibiting surgery include high operative risk (6-16% in-hospital mortality), multiple comorbidities, advanced age, and lack of effectiveness.4, 10-12


 


TriClip™ TEER Therapy can offer an alternative solution for:
 


 


 

Abbreviations and References

Abbreviations: TGA, Therapeutic Goods Administration.

1. Abbott Press Releases. Abbott's TriClip™ Becomes First Device of its Kind to Receive Ce Mark for Minimally Invasive Tricuspid Valve Repair. Accessed March 2022: https://abbott.mediaroom.com/2020-04-09-Abbotts-TriClip-TM-Becomes-First-Device-of-its-Kind-to-Receive-CE-Mark-for-Minimally-Invasive-Tricuspid-Valve-Repair#:~:text=Abbott's%20TriClip%E2%84%A2%20Becomes%20First,Valve%20Repair%20%2D%20Apr%209%2C%202020

2.  CSANZ 2021: Tricuspid regurgitation prevalent, severe, and lethal. An Australian national database was used to assess prevalence and outcomes. Cardiology. 2021;6(4).

3.  Benjamin EJ, et al. heart disease and stroke statistics—2018 Update. A report from the american heart association. Circulation. 2018;137:e67–e492.

4. Enriquez-Sarano M, et al. Tricuspid regurgitation is a public health crisis [published online ahead of print November 9, 2019]. Prog Cardiovasc Dis. 2019;62(6):447-451.

5. D’Agostino RS, et al. The STS adult cardiac surgery database: 2018 Update. Ann Thorac Surg. 2018;205:15-23.

6. Topilsky, Y. et al. Burden of TR in patients diagnosed in the community setting. JACC Cardiovasc Imaging. 2019;12(3):433-442.

7. Topilsky, Y. Tricuspid valve regurgitation: epidemiology and pathophysiology. Minerva Cardioangiologica. 2018;66(6):673-679.

8. Nath J, et al. Impact of tricuspid regurgitation on long term survival. J Am Coli Cardio. 2004;43:405-409.

9. Benfari G, et al. Excess mortality associated with functional tricuspid regurgitation complicating heart failure with reduced ejection fraction. Circulation. 2019;16;140(3):196-206.

10. Wong WK, et al. Late outcomes of valve repair versus replacement in isolated and concomitant tricuspid valve surgery: a nationwide cohort study. J Am Heart Assoc. 2020;9(8):e015637. 

11. Moraca RJ, et al. Outcomes of tricuspid valve repair and replacement: a propensity analysis. Ann Thorac Surg. 2009;87(1):83-88; discussion 88-89.

12. Asmarats L, et al. Transcatheter tricuspid valve interventions: landscape, challenges, and future directions. J Am Coll Cardiol. 2018;71(25):2935-2956.

Why Choose the TriClipTEER System?1-4

TriClip™ TEER Therapy is a low-risk, non-surgical alternative treatment for tricuspid regurgitation (TR) that offers a sustained reduction of TR with significant improvements in clinical outcomes.

Minimally Invasive

Transcatheter beating heart procedure (femoral venous access) with no cardiopulmonary bypass.

Improved Quality of Life

Life changing improvements in health-related quality of life.

Short Hospital Stay

With fast recovery times many patients go home the next day.

Discover TriClip™ TEER System Features

Building on a Legacy of Unmatched  Edge-to-Edge Repair (TEER) Expertise5

TriClip™ Implants use the same proven leaflet technology as our MitraClip™ TEER System. TriClip TEER System is the clip-based technology physicians know and trust, with a delivery system uniquely designed for the tricuspid valve.
 


TriClip™ Implant Features

  • Cobalt-chromium and Nitinol construction
  • Polyester cover designed to promote tissue growth
  • Magnetic resonance conditional to 3 Tesla

Static magnetic field up to 3 T; maximum spatial gradient in static field of 4000 gauss/cm or less; maximum whole-body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning.

Four Implant Sizes for Tailored Treatment6


*Abbott. Data on File. RPT2122822-R and RPT2124838-R.


The TriClip™ G4 Delivery System


 

Unmatched Stability, Precision, Control.7*

* Based on Abbott simulated horizontal tensile testing.

TriClip™ TEER System is the first and only transcatheter valve repair system intentionally designed for the right heart.8,9


 


The testimonials relate to accounts of individuals’ responses to treatments. The patients’ accounts are genuine, typical and documented. However, it does not provide any indication, guide, warranty, or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

Abbreviations and References

Abbreviations: TGA, Therapeutic Goods Administration.

1. Abbott Press Releases. Abbott's TriClip™ Becomes First Device of its Kind to Receive Ce Mark for Minimally Invasive Tricuspid Valve Repair. Accessed March 2022: https://abbott.mediaroom.com/2020-04-09-Abbotts-TriClip-TM-Becomes-First-Device-of-its-Kind-to-Receive-CE-Mark-for-Minimally-Invasive-Tricuspid-Valve-Repair#:~:text=Abbott's%20TriClip%E2%84%A2%20Becomes%20First,Valve%20Repair%20%2D%20Apr%209%2C%202020

2. Lurz P, et al. Trasncatheter edge-to-edge repair for treatment of tricuspid regurgitation. J Am Coll Cardiol. 2021;77(3):229-239.

3. Von Bardeleben RS, et al. Percutaneous edge-to-edge repair for tricuspid regurgitation: 2-year outcomes from the TRILUMINATE trial. Presented at: EuroPCR 2021.

4. Lurz P, et al. Real-world outcomes for tricuspid edge-to-edge repair: initial 30-day results from the TriClip bRIGHT Study. Presented at: PCR London Valves 2021.   

5. Abbott. Data on File.

6. Abbott. Data on File. PS2203400.

7. Testing performed by and data on file at Abbott. RPT2133700.

8. Abbott. Data on File. PS2203401.

9. Abbott. Data on File. PS2203200.

Clinical Evidence Supporting TriClip™ TEER System

Leading Clinical Outcomes2.3


 


 


 


Procedural Safety and Success Rates3
 

Ongoing TriClipTM TEER System Clinical Studies:
 

Abbreviations and References

Abbreviations: 6MWD, 6-minute walk distance; KCCQ-OS, Kansas City Cardiomyopathy Questionnaire Overall Summary; NYHA New York Heart Association; TGA, Therapeutic Goods Administration, TR; tricuspid regurgitation.

1. Abbott Press Releases. Abbott's TriClip™ Becomes First Device of its Kind to Receive Ce Mark for Minimally Invasive Tricuspid Valve Repair. Accessed March 2022: https://abbott.mediaroom.com/2020-04-09-Abbotts-TriClip-TM-Becomes-First-Device-of-its-Kind-to-Receive-CE-Mark-for-Minimally-Invasive-Tricuspid-Valve-Repair#:~:text=Abbott's%20TriClip%E2%84%A2%20Becomes%20First,Valve%20Repair%20%2D%20Apr%209%2C%202020

2. Lurz P, et al. Trasncatheter edge-to-edge repair for treatment of tricuspid regurgitation. J Am Coll Cardiol. 2021;77(3):229-239.

3. Nickenig G, et al. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet. 2019;394(10213): 2002-2011.

TriClip™ TEER System Procedure

In the TriClipTM TEER System procedure, the TriClipTM implant is placed on two leaflets or more of the tricuspid valve. This reduces tricuspid regurgitation, and the valve continues to open and close on either side of the implant, allowing blood to flow through. Often, more than one TriClipTM implant will be used on tricuspid valve leaflets. 

  • Transcatheter beating heart procedure — no cardiopulmonary bypass. This procedure does not require opening the chest and temporarily stopping the heart.
  • Allows for real-time positioning and repositioning to optimise TR reduction.
  • Femoral venous access.
  • Can be used in a standard Cath Lab or hybrid room.
  • No pre-procedural CT required.
  • Magnetic resonance conditional to 3 Tesla.

Static magnetic field up to 3 T; maximum spatial gradient in static field of 4000 gauss/cm or less; maximum whole-body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning.

TriClip™ TEER System Imaging

Pre- and Post- TriClip™ Therapy

TriClipEdge-to-Edge Repair (TEER)*

*The TriClip™ Implant was implanted successfully in all patients.

Watch TriClip™ in Action
 

TriClip™ TEER is a new treatment for tricuspid valve regurgitation


 

Abbreviations and References

Abbreviations: TEE, Transesophageal Echocardiography; TGA, Therapeutic Goods Administration.

1. Abbott Press Releases. Abbott's TriClip™ Becomes First Device of its Kind to Receive Ce Mark for Minimally Invasive Tricuspid Valve Repair. Accessed March 2022: https://abbott.mediaroom.com/2020-04-09-Abbotts-TriClip-TM-Becomes-First-Device-of-its-Kind-to-Receive-CE-Mark-for-Minimally-Invasive-Tricuspid-Valve-Repair#:~:text=Abbott's%20TriClip%E2%84%A2%20Becomes%20First,Valve%20Repair%20%2D%20Apr%209%2C%202020

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Disclaimer for Patient Outcomes: The information provided is not intended for medical diagnosis or treatment or as a substitute for professional medical advice. Consult with a physician or qualified healthcare provider for appropriate medical advices.

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