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Mitral Regurgitation (MR)

MR in Australia2-5

~500-600K

Australians were living with heart valve disease in 2021

Estimated to be >400k Australians with MR

MR is the most common specific type of heart valve disease

Age-Related

~1-2% in <60 years and ~9-11% in those > 70 years

Expected Increase to ~670K in 2051

With ~30% having moderate to severe disease



 

For many patients with MR, surgery is contraindicated and medications are insufficient  

49% of patients with symptomatic severe MR were not operated due to age, co-morbidities, or impaired LV.6*
MR patients who most need intervention are often the most likely to be denied surgery.6

*Based on a survey of severely symptomatic MR patients in NYHA Class III-IV (n = 396); 10% had surgery the following year. The remainder had no surgery; medical management only.


 

A Leaky Heart Valve Reduces Quality of Life7-9

In some cases, people with a leaky valve (mitral regurgitation) may never experience symptoms of heart failure, and the condition can worsen when the heart is unable to pump enough blood to meet the body’s demands.


 

The most common symptoms of MR include:

Shortness of breath

Fatigue

Dry, hacking cough

Excessive urination

Fainting

Swollen feet or ankles

Inability to exercise

Decrease in appetite

If left untreated, up to 57% of people with a leaky valve may not survive 1 year.10-12


 

Is there an Option for Those with Significant MR?

MitraClip™ TEER Therapy is an option for patients with significant MR who are not candidates for surgery.7

It is ideal for:13,14

 

 

 

 

Abbreviations and references

Abbreviations: GDMT: Guideline directed medical therapy; NYHA: New York Heart Association.

References: 

1. Data on file at Abbott.

2. Marwick T, et al. Our Hidden Aging: Time to Listen to the Heart.

3. Nkomo VT, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-11.

4. Singh JP, et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol. 1999;83(6):897-902.

5. Samad Z, et al. Long-term outcomes of mitral regurgitation by type and severity. Am Heart J.  2018;203:39-48.

6. Mirabel M, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358- 1365.

7. Nishimura RA, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;136(9):1–123.

8. Baumgartner H, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease: The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2017;00:1-53.

9. Ponikowski P, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016;18(8):891-975.

10. Enriquez-Sarano M, et al. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005;352(9):875-883.

11. Cioffi G, et al. Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. Eur J Heart Fail. 2005;7(7):1112-1117.

12. Grigioni F, et al. MIDA Investigators. Outcomes in mitral regurgitation due to flail leaflets: a multicenter European study. JACC Cardiovasc Imaging. 2008;1(2):133-141.

13. ANZ MitraClip Delivery System IFU.

14. Stone GW, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018; 379:2307-2318.

 

Why Choose MitraClip™ TEER Therapy?2-7

MitraClip™ TEER Therapy is an option for patients with significant mitral regurgitation (MR) who are not candidates for surgery. It is the only mitral valve device shown to improve survival of heart failure patients with secondary MR.

Minimally Invasive

Less invasive than traditional open-heart surgery. The device is implanted via a catheter that is inserted through an incision in the upper leg.

Improved Quality of Life

Most patients experience improvements in symptoms and quality of life after the procedure.

Short Hospital Stay

Patients are usually released from the hospital within 2 to 3 days, significantly less time compared to surgery.

Discover MitraClip™ TEER Implant Features:

4th generation technology, with durable outcomes demonstrated to 5 years.8-12

Tailored for Patient Anatomies with an Expanded Portfolio of Clip Sizes*

*MitraClip G4 IFU.

Designed to further reduce regurgitant volume with a single clip.

Treat More Patients with More Options13,14*

Treating a broad range of valve anatomies and the ability to choose clip size based on mitral valve anatomy.

Clip Selection ConsiderationsFavours
G4 NTW		Favours
G4 NT		Favours
G4 XTW		Favours
G4 XT
Leaflet Length < 9mm++  
Leaflet Length ≥ 9mm  ++
Broad Jet+ + 
Smaller Valve +  
Larger Valve+ ++

 

MitraClip G4 Clip Selection recommendations are based on the clinical experience of physicians. The EXPAND G4 observational study establishes adherence to Clip Size Selection Recommendations and their associated outcomes.
* MitraClip G4 Instructions for use

Optimised with Controlled Gripper Actuation (CGA) Functionality and Steerable Guide Catheter (SGC)*,**

*Test performed by and data on file at Abbott

**MitraClip G4 IFU

Predictable Procedure Experience13*

Precision and stability from delivery system specifically designed for the mitral valve. The innovative Clip Delivery System is a highly manoeuvrable delivery catheter, which implants the MitraClip™ TEER Implant via a steerable guide catheter.

*Tests performed by and data on file at Abbott.


† 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.

Abbreviations and references

Abbreviations: GDMT: Guideline-directed medical therapy.

References:

1. Data on file at Abbott.

2. Nishimura RA, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;136(9):1–123.

3. Stone GW, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018;379:2307-2318.

4. Lim DS, et al. Contemporary Outcomes with MitraClip (NTRXTR) System In Primary Mitral Regurgitation Results From The Global EXPAND, ACC 2020.

5. Mack M. COAPT: Three-year outcomes from a randomized trial of transcatheter mitral valve leaflet approximation in patients with heart failure and secondary mitral regurgitation. Presented at TCT 2019.

6. Sorajja P, et al. Outcomes with transcatheter mitral valve repair in the United States: An STS/ACC TVT registry report. J Am Coll Cardiol. 2017;70(19):2315-2327.

7. Arnold SV, et al. Health status after transcatheter mitral valve repair in heart failure and secondary mitral regurgitation. J Am Coll Cardiol. 2019;73(17):2123-2132.

8. Feldman T. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation 5-Year Results of EVEREST II. J Am Coll Cardiol. 2015;66(25):2844–2854.

9. Kar S. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart. 2018;0:1–7.

10. Lim S. Five-Year Durability Results of Transcatheter Mitral Valve Repair with the MitraClip System in Patients with Severe Degenerative Mitral Regurgitation and Prohibitive Surgical Risk. Poster presented at ACC 2018.

11. Feldman T. The EVEREST II REALISM Continued Access Study: Five-Year Outcomes in High Surgical Risk Patients. Data presented at PCR 2018.

12. Feldman T. The EVEREST II REALISM Continued Access Non-High-Risk Study: Mid- and Long-Term Follow-up in Surgical Candidates. Data presented at ESC 2017.

13. Rottbauer WD. Contemporary Clinical Outcomes with MitraClip™ (NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study. Data presented at PCR 2020.

14. Maisano F. Clip Selection Strategy and Outcomes with MitraClip™ (NTR/XTR): Evidence-Based Recommendations from the Global EXPAND Study. Data presented at PCR 2020.

 

Why have over 150,000 Patients had MitraClip™ TEER Therapy?1-4


 

Proven Results with MitraClip™ TEER Therapy

Clinical benefits remain durable up to 5 years:5-10


 

Long-term safety and efficacy of MitraClip™ TEER Therapy in high-surgical-risk patients

 

Reduction and Stability of Left Ventricular (LV) Volumes

 

 

Improvement in NYHA Functional Class

 

 


 

Reduction in MR Severity

 


 


 

Globally, MitraClip™ TEER Therapy has 18+ Years of Clinical Experience1

With more ongoing studies like:

Abbreviations and references

Abbreviations: NYHA: New York Heart Association; QoL: quality of life; RRR: relative risk reduction.

References:

1. Data on file at Abbott.

2. Mack M. COAPT: Three-year outcomes from a randomized trial of transcatheter mitral valve leaflet approximation in patients with heart failure and secondary mitral regurgitation. Presented at TCT 2019.

3. Arnold SV, et al. Health status after transcatheter mitral valve repair in heart failure and secondary mitral regurgitation. J Am Coll Cardiol. 2019;73(17):2123-2132.

4. Kar S. Core-Lab Adjudicated Contemporary Clinical Outcomes at 1 Year with MitraClip™ (NTR/XTR) System from Global EXPAND Study. Data presented at TCT 2020.

5. Feldman T. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation 5-Year Results of EVEREST II. J Am Coll Cardiol. 2015;66(25):2844–2854.

6. Kar S. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart. 2018;0:1–7.

7. Lim S. Five-Year Durability Results of Transcatheter Mitral Valve Repair with the MitraClip System in Patients with Severe Degenerative Mitral Regurgitation and Prohibitive Surgical Risk. Poster presented at ACC 2018.

8. Feldman T. The EVEREST II REALISM Continued Access Study: Five-Year Outcomes in High Surgical Risk Patients. Data presented at PCR 2018.

9. Feldman T. The EVEREST II REALISM Continued Access Non-High-Risk Study: Mid- and Long-Term Follow-up in Surgical Candidates. Data presented at ESC 2017.

10. Kar S, et al. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart. 2019;105(21):1622-1628.

Clinical Practice

The Referral Process2-5

Imaging

Imaging is used for screening patients to determine an MR diagnosis and whether a clip is needed and suitable. It is also used to facilitate the procedure of clip insertion.

Imaging for MitraClip™ TEER Implant Follows a Systematic Protocol:

Pre-procedural screening transthoracic echocardiogram (TTE) which includes mitral valve anatomical evaluation, quantification and aetiology of MR, overall patient eligibility and safety for the MitraClip™ TEER Implant.

Apical four chamber view showing mitral regurgitation

Parasternal short-axis view showing mitral valve area via planimetry

Parasternal long-axis view showing vena contracta

3D en face view of mitral valve

Pre-procedural screening transesophageal echocardiogram (TOE) which includes mitral valve anatomical evaluation, quantification and aetiology of MR, overall patient eligibility and safety for the MitraClip™ TEER Implant.

Mid-oesophageal, 5-chamber view showing mitral regurgitation with A1/P1 scallops of the mitral valve visualised

Bi-commissural midline view showing mitral regurgitation with P1/A2/P3 scallops of the mitral valve visualised

xPlane imaging showing the simultaneous (1) bicommissural and (2) long axis views of  the A2/P2 scallops of the mitral valve

xPlane imaging showing the simultaneous (1) bicommissural and (2) long axis views of  the A2/P2 scallops of the mitral valve (with Colour Doppler)

Mitral valve area measured from  3D MPRs (multiplanar reconstruction)

3D enface view of a P2 prolapse

Procedural (Transesophageal echo-TOE) helps guide the transseptal puncture, clip trajectory, clip positioning, leaflet capture, leaflet insertion assessment, clip stability, MR severity and mean pressure gradient.

Transseptal Bicaval view showing inferior – superior tenting location

Clip positioning  3D en face view showing clip arms perpendicular to line of coaptation in the Left Atrium

Transseptal Short axis view at base showing anterior-posterior tenting location

Clip positioning Long-axis view showing gripper identification

Positioning and trajectory- Bicommissural 2 chamber view with colour

Leaflet insertion assessment 3D en face view showing tissue bridge

Clip positioning Bicommissural xPlane view showing MitraClip position

Post-procedural (Transthoracic or Transesophageal echo-TTE or TOE) imaging used to evaluate MitraClipTM TEER through assessment of clip position, clip stability, MR severity and mean pressure gradient.

Baseline MR

Visible MR reduction after Clip deployment

All Data and Images on file at Abbott.

MitraClip™ TEER Therapy Procedure

  • Procedure is performed using femoral venous access and real-time imaging (echocardiography and fluoroscopy), thereby avoiding cardiopulmonary bypass.
  • Transcatheter beating heart procedure allows for real-time positioning and repositioning to optimise MR reduction.
  • Can be used in a standard cath lab or hybrid room.
  • Implants are safe under labelled magnetic resonance imaging (MRI) scanning conditions.§

§ Non-clinical testing has demonstrated that the MitraClip implants are MR conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
Static magnetic field of 1.5-Tesla (1.5 T) or 3-Tesla (3.0 T)
Maximum spatial field gradient of 4,000 Gauss/cm (40 T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ¬2 W/kg (Normal operating mode)

Increased Procedure Efficiency6,7*

* MitraClip G4 IFU, in comparison to traditional MitraClip™ System


 

Abbreviations and references

Abbreviations: GDMT: Guideline-directed medical therapy.

References:

1. Data on file at Abbott.

2. ANZ MitraClip Delivery System IFU.

3. McMurray JJV, et al. Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure. N Engl J Med. 2014;371:993-1004.

4. Vahanian A, et al. ESC/EACTS Scientific Document Group, 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2022;43(7):561–632.

5. Otto C, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. J Am Coll Cardiol. 2021;77(4):e25-e197.

6. MitraClip G4 System Instructions for Use.

7. Chehab Bassem M. Contemporary Clinical Outcomes with the Transcatheter Mitral Valve Repair using MitraClip™ G4 System: Core Laboratory Echocardiographic Results in EXPAND G4 Study. Data presented at PCR Valves eCourse 2020.


 

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