thaden.presentation - mnacvpr10/3/16 4 ©2016 mfmer | slide-19 treatment mitral valve repair vs...

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©2016 MFMER | slide-1

MitraClip® Therapy: Technique and Implications for Cardiac Rehab

Jeremy Thaden, MD Minnesota Association of Cardiovascular and Pulmonary Rehabilitation

October 7, 2016


Disclosures • None


Objectives • Learn the normal anatomy and function of the

mitral valve and the basic pathophysiology of mitral regurgitation.

• Learn the natural history of untreated mitral regurgitation and current treatment options.

• Review the transcatheter mitral valve repair (edge-to-edge repair or MitraClip) procedure.

• Discuss common comorbidities and important considerations in post-MitraClip patients undergoing cardiac rehabilitation.


Transcatheter Structural Heart Procedures Recent Growth in Volume and Complexity •  Transcatheter aortic valve replacement

•  Percutaneous paravalvular regurgitation closure

•  Left atrial appendage occlusion

•  Transcatheter mitral valve repair (edge-to-edge repair; MitraClip)


Normal Mitral Valve Structure and Function


Mitral Valve Normal Anatomy

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Mitral Valve Normal Anatomy


Mitral Regurgitation Abnormal Valve

Primary/Organic MR

Valve Disease Ventricular consequences

Normal Valve

Secondary/ Functional MR

Ventricular disease Valve consequences


Assess the Mechanism of Regurgitation Primary Regurgitation


Assess the Mechanism of Regurgitation Secondary Regurgitation

©2016 MFMER | slide-11 Nkomo et al. Lancet 2006

Global Burden of Valve Disease Prevalence by Age


Nkomo et al. Lancet 2006 Mirabel et al. EHJ 2007

Burden of Mitral Regurgitation Prevalence and Adherence to Guidelines

• 7-10% of individuals ≥75 years of age have ≥moderate mitral regurgitation

• Surgery is pursued in only ~50% of eligible patients

• Reasons patients denied surgery: • Decreased left ventricular ejection fraction • Advanced age •  Increased comorbidities •  Less severe mitral regurgitation

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Pathophysiology Acute Mitral Regurgitation • Mitral regurgitation enhances

ventricular emptying • Ejection fraction increases • Forward stroke volume

decreases • Markedly increased left atrial

pressure • Pulmonary edema and

congestive heart failure


Acute Primary Mitral Regurgitation Flail Posterior Leaflet


Pathophysiology Chronic Mitral Regurgitation • The left atrium and left ventricle dilate (eccentric

hypertrophy) due to chronic volume overload • Ejection fraction is increased • Forward stroke volume preserved • Left atrial pressure modestly elevated • Left ventricular dysfunction may be present

despite normal ejection fraction

©2016 MFMER | slide-16 Ling LH et al. N Engl J Med 1996;335:1417-1423.

Incidence of Atrial Fibrillation (AF), Congestive Heart Failure (CHF), Mitral-Valve Surgery, and Surgery or Death.


Mitral Valve Surgery for Severe Regurgitation Indications for PRIMARY regurgitation

• Class I (strongest recommendation) • Symptoms •  LV ejection fraction <60% or LVESD ≥40 mm

• Class IIa (should do for most patients) • Asymptomatic with high likelihood of repair • New atrial fibrillation or PA systolic pressure

>50 mm Hg • Class IIb (reasonable to consider)

• Symptomatic with EF <30%


Mitral Valve Surgery for Severe Regurgitation Indications for SECONDARY regurgitation

• Class I (strongest recommendation) • None

• Class IIa (should do for most patients) • None

• Class IIb (reasonable to consider) • Class III-IV symptoms

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Treatment Mitral Valve Repair vs Replacement

CP908602- 19

0

20

40

60

80

100

0 2 4 6 8 10

Expected

Replacement Repair

P=0.0004

Overall survival (%)

Years

68%

52%


Contemporary Mitral Valve Repair Triangular Resection with Annuloplasty Band

Sarano, Lancet 2009


Alfieri Mitral Valve Repair

Feldman et al. JACC 2009 ©2016 MFMER | slide-22

Transcatheter Edge-to-Edge Mitral Valve Repair

MitraClip Animation


Transcatheter Mitral Valve Repair Edge-to-edge Repair

•  Approved in high risk primary mitral regurgitation

•  Ongoing studies in secondary (functional) mitral regurgitation

•  Improves symptoms and survival

•  Compared to open MV repair: •  Similar NYHA class at 4 years •  Similar survival at 4 years •  More likely to need open reoperation

Mirabel et al EHJ 2007 Feldman et al NEJM 2011 Mauri et al JACC 2013 ©2016 MFMER | slide-24

3D Echocardiography (TEE) allows visualization of the Mitral Valve

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3D Echocardiography: Clinical Application Evaluating Mitral Valve Pathology



Echocardiography-Fluoroscopy Fusion MitraClip Guidance


MitraClip Therapy for Mitral Regurgitation NYHA Functional Class

Mauri et al. JACC 2013


MitraClip Therapy for Mitral Regurgitation Mitral Regurgitation Severity

Mauri et al. JACC 2013 ©2016 MFMER | slide-30

MitraClip Therapy for Mitral Regurgitation Survival compared to mitral valve repair

Mauri et al. JACC 2013

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Transcatheter Mitral Valve Repair Pre-procedural Considerations

Feldman et al NEJM 2011 ©2016 MFMER | slide-32

66 year old male with severe exertional dyspnea, referred for MitraClip.

• Past medical history: • Severe primary mitral regurgitation • CAD with prior coronary bypass operation • Moderate COPD • Chronic atrial fibrillation, on warfarin • Obesity • Hypertension • Hyperlipidemia • Chronic anemia


Transcatheter Mitral Valve Repair Mechanism and Location of Jet


Transcatheter Mitral Valve Repair Procedural Guidance

Feldman et al. NEJM 2011


Transcatheter Mitral Valve Repair Post-Procedural Assessment

Based on the result shown (right), which of the following is the most appropriate next step: A. End the procedure, there is only

mild residual regurgitation. B. Continue the procedure, try

another clip C. Refer the patient for mitral valve

replacement D. Refer the patient for open mitral

valve repair


Transcatheter Mitral Valve Repair Second Clip

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Transcatheter Mitral Valve Repair Third Clip, Final Result

First Clip


Transcatheter Mitral Valve Repair Procedural Details • Procedural time 1-4 hours • Hospital length of stay 3 days • 87% discharged to home


Transcatheter Mitral Valve Repair Potential Complications

• Stroke (1%) • Partial clip detachment (2%) • Mitral stenosis (0.5%) • Pericardial tamponade (2%) • Device embolization (rare) •  Injury to atrial septum (rare)


Benefits of Cardiac Rehab After MitraClip?


Cardiac Rehab After Open Heart Surgery Benefits After Heart Valve Surgery

• Increased rates of return to work • Improved aerobic capacity/6 minute walk • Improved quality of life scores • Decreased rates of anxiety/depression

• Cost neutral • Adverse events rare


Cardiac Rehabilitation Post-MitraClip • No data on benefit in post-MitraClip patients • Could we infer benefit based on the typical

profile of a MitraClip patient? • Could we extrapolate data from other minimally

invasive valve procedures with similar patient demographics? e.g. Transcatheter aortic valve replacement

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Cardiac Rehabilitation Post-MitraClip Patient Considerations

• Frequent concurrent heart failure • High risk for readmission • Frequent atrial arrhythmias/atrial fibrillation • Frequently:

• Frail • Deconditioned • Multiple comorbities

•  Increased rates of depression, anxiety, lower sense of physical well-being1

1Nikendi et al. Psychosomatic Med 2016 ©2016 MFMER | slide-44

Cardiac Rehabilitation After TAVR Improved 6 minute walk

Voller et al. Eur J Prev Cardiol 2015


Cardiac Rehabilitation After TAVR Improved maximal exercise capacity

Voller et al. Eur J Prev Cardiol 2015 ©2016 MFMER | slide-46

Post-MitraClip Restrictions • No driving for 24 hours (sedation) • Shower after 24 hours, bathtub after 48

hours • For 3 days, avoid the following:

• Activities that involve straining • Lifting more than 10 lbs • Strenuous activities

• **No sternotomy restrictions!


Summary • Mitral regurgitation is among the most

frequent valve lesions affecting elderly individuals.

• Individuals are frequently not referred to surgery due to ….

• Transcatheter mitral valve repair (MitraClip) is an option for some patients with severe mitral regurgitation at high surgical risk.


Summary • Post-MitraClip patients are frequently elderly,

frail, deconditioned, and often have multiple comorbidities:

• No data is currently available supporting cardiac rehabilitation in Post-MitraClip patients, however:

• Data indicate multiple benefits in patients after open mitral valve repair/replacement

• Data indicate cardiac rehabilitation is safe and efficatious in post-TAVR patients (similar demographic to MitraClip patients)

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thaden.presentation - mnacvpr10/3/16 4 ©2016 mfmer | slide-19 treatment mitral valve repair vs...

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