Improvement of New York Heart Association (NYHA) Functional Status in High Risk Patients with Severe Mitral Regurgitation Following Percutaneous MitraClipTM Procedure

William Kong, Michael Liang, James Yip, Edgar Tay

National University Heart Centre, Singapore

2

Disclosure Statement of Financial Interest

I, Michael Liang, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Background/MitraClip Procedure

• MitraClipTM has been increasingly performed in Asian countries since 2011.

• Worldwide over 20,000 procedures performed.

MitraClipTM, Abbott Vascular

24Fr Delivery System

Aim

• Our study is to evaluate the effectiveness of improvement of heart failure symptoms and functional status in heart failure patients with percutaneous method of reduction of mitral incompetence/regurgitation (MR) with the MitraClip system.

Baseline NYHA NYHA status @ 6

months

NYHA (New York Heart Association) Functional Classifications

NYHA Class Symptoms

I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc.

II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). Comfortable only at rest.

IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

5 The Criteria Committee of the New York Heart Association. (1994). Nomenclature and

Criteria for Diagnosis of Diseases of the Heart and Great Vessels. (9th ed.). Boston: Little,

Brown & Co. pp. 253–256.

Methods

• Patients were selected for the MitraClip procedure based on the consensus of the Heart Team in our centre.

• Between February 2012 and December 2013, 24 patients with severe MR who were considered high risk for mitral valve surgery had percutaneous MitraClip procedure.

• All the patients underwent clinical and echocardiographic evaluation at baseline, and at 6-month follow-up. Mortality data, including cause of death, were collected.

• Exclusion criteria: those who are suitable surgical candidate.

Unsuitable Features

Results • Demographics

N=24

Age, years-old + SD 67 + 11

Gender, % males 58%

Mean Euroscore 21

NYHA III or IV Symptom 92%

LV ejection fraction < 50% 46%

Functional MR 46%

Degenerative MR 54%

Severe MR* 75%

Moderate Severe MR* 25%

Procedural Success§ 96%

* Final grading of Echo MR by imaging specialists and valve round review § 1 Failed case was severe MR due to Barlow’s valve. Both anterior and posterior leaflets had prolapse.

Results: Procedure-related Complications

Category %

Mortality 0

Myocardial infarction 0

Stroke 4% (n=1, minor)

Vascular Access site, major bleeding 0 *1 failed proglide closure device

Results: Pre-procedure and 6 month echo results

Category Pre-Procedural 6 Months post-procedure

P Value

LVEF 46 + 18 45 + 18 0.65

Stroke Volume 56 + 23 51 + 24 0.30

End systolic Vol 69 + 42 71 + 60 0.78

End Diastolic Vol. 122 + 43 110 + 42 0.14

LA Index 34 + 8 31 + 6 0.39

PASP 47 + 14 42 + 13 0.29

MR (0-4) 3.7 + 0.5 1.4 + 0.5 <0.01

Results: Echocardiographic MR grading before and 6 months after procedure

Excluded 1 failed case

P<0.01

Results: Pre-Procedure and 6-months NYHA Status

I-II >90% I & II

P<0.01

Results: Post-successful 6-months clinical results

Category n=23 n (%)

Mortality 0 (0)

Stroke 1 (4)

Early Clip detachment, < 30 days 0 (0)

Late Clip detachment, > 30 days 1 (4)

Unsuccessful patient 1(4%) : Passed away approx. 1 week later due to heart failure.

Case: 53 yr F. Severe MR, EF 25%, ESD64mm. NYHA III.

Transoesophageal echocardiography (TEE) Grade 4+ MR, Malcoaptation of A2/P2, A3/P3

MR: 4+ 2+ Cardiac Output: 2.2 3.0 L/min Mean PA 50 32mmHg NYHA III II

Deployed 2 MitraClips

3 months follow-up stable.

5 months later presented with acute heart failure with detached lateral MitraClip

Tay et al. Redo MitraClip mitral valve repair after a late single leaflet detachment. Catheter Cardiovasc Interv. 2014 Jul 1;84(1):160-3.

Conclusion

• Results of our initial experience in the MitraClip system in patients who are at high risk for mitral valve surgery demonstrated that percutaneous MitraClip is effective, low risk , and leads to significant improvement in NYHA functional class in approximately 90% of patients with heart failure.

• Both functional and degenerative MR could be considered for MitraClip.

LIMITATION:

- Small number of highly selected patients. Lacks of long term follow-up.

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