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MULTI-DISCIPLINARY APPROACH TO MITRAL DISEASE

Nikolaos Kakouros, MBBS MRCP PhD MD(Res) FACC FSCAI Director, Structural Heart Disease programProgram Director, Interventional Cardiology SHD FellowshipCo-director, TAVR programAssistant Professor of MedicineUniversity of Massachusetts Medical School

CARDIOLOGIST

Conflicts of Interest

▪ I do not have any financial arrangements or affiliations with any of the corporate organizations offering financial support or educational grants for this continuing medical education program

Objectives

▪ Understand catheter based approaches to mitral valve disease

▪ Describe the evaluation and indications for catheter based interventions

▪ Describe the common complications associated with catheter based intervention

Multi-disciplinary Approach To Mitral Disease

Russell C Brock (1903-1980) leading British chest and heart surgeon

Pioneer of modern open heart surgery

▪ 1947 - Surgical pulmonary valve dilation and infundibular muscle resection in Fallot’s tetralogy to reduce R-L shunt

▪ Exchange professorships with Dr Alfred Blalock at JHH

helped introduce new tech (hypothermia, heart-lung machine) to the nascent field of cardiac surgery

Russell C Brock (1903-1980)

1948 – One of first four surgeons to operate

on rheumatic mitral stenosis

Finger-fracture Valvuloplasty

(closed commissurotomy)

RC Brock on Intracardiac Surgery

‘Intracardiac surgery is not for the lone worker. Team work is essential … success is due principally to the loyal and unstinted co-operation of my various colleagues who take part with me in this work both at Guy’s and the Brompton Hospital. To give one example, at Guy’s there is a group of some 15 people actively engaged in the work, and as time passes we find that more and more are drawn into the team.’

Peacock Club – 70 years ago

▪ Established 4/21/1948 as meeting of “those concerned in the management of congenital disease of the Heart” convened by RC Brock

▪ Thomas Peacock – author of 19C text on cardiac malformations

▪ Core Members: Guy’s cardiologists

Clinical scientists from Medical Research Council

Radiologist

Anesthetists

Surgical assistants

Junior doctors and research fellows

Invited speakers and named visitors

Peacock Club

▪ Discussions of life threatening risks of the invasive investigations

▪ Shared management planning

▪ Self-critical reviews of operations that often went badly

Hearts of the patients who died were critically examined in the presence of the whole team

▪ Meticulous documentation of treated and untreated cases.

THE MITRAL VALVE

MDT approach :MITRAL VALVE DISEASE

STENOSIS REGURGITATION

MITRAL STENOSIS ETIOLOGY

RHEUMATIC60%, nearly all adult MS

CALCIFIC

•Misc: Congenital (parachute MV), post-inflammatory,

mucopolysaccharidosis, LA myxoma

The problem

▪ Rheumatic Heart Disease prevalence: Industrialized nations 1/100 000 Worldwide: 12 000 0000 Rh Fever and Rh Heart Disease cases

(Circulation. 2009;119:e211-e219)

0.14/1000 in Japan, 1.86/1000 in China, 0.5/1000 in Korea, 4.54/1000 in India, 1.3/1000 in Bangladesh

▪ Why? Streptococcal GrpA infection → Type II hypersensitivity overpopulation, overcrowding, poverty, poor access to

medical care, limited availability of PCN

Rheumatic Mitral valve stenosis

• Valve thickening

• Commissural fusion

• Chordal fusion

• Normal Valve area 4-5cm2

RHEUMATIC MITRAL STENOSIS

RHEUMATIC MITRAL STENOSIS

RHEUMATIC MITRAL STENOSIS

Mitral Stenosis

Severe mitral stenosis: MVA <1.5cm2

Critical mitral stenosis MVA < 1.0 cm2

• Asymptomatic• Present with incapacitating dyspnea

• Pulmonary hypertension

• Hemoptysis

• Right heart failure, peripheral edema, orthopnea

• Atrial fibrillation: 80%

• Systemic thromboembolism: 20%

MitralCommissurotomy

1902 : Proposed by Brunton

1920s: First successful surgical commissurotomy

1940-1950s: Trans-atrial and transventricularsurgical commissurotomy were accepted clinical procedures. Open commissurotomy preferred in the US

1980s: PTMV emerged

1994: Clinically approved

21st Century: PTMV is the preferred procedure

• Angelo Thomas Pezzella et al: Ann. Afr. Chir. Thor. Cardiovasc. 2012;7(1)

• International Children’s Heart Fund

Treatment for Mitral Stenosis

PMBC vs SURGERY

Balloon vs. Open Surgical

Turi et al, Circulation, 83, 1179-85, 1991

Mit

ral

Va

lve

Are

a(c

m2)

PMV vs OMC vs CMC

MVA at seven years follow-upPMV OMC CMC

0

0.5

1.5

1

2.5

2

3

Baseline 6 Months

P=0.001

7 Years

P=0.001

P=NS

P=NS

0.9 0.9 0.9

P=NS

2.1 2.2

1.61.8 1.8

1.3

Farhat et al. Circulation 1998

CONCLUSIONS

• PTMV and OMC have comparable initial results and low

rates of restenosis, and both produce good functional

capacity for at least three years.

• The better hemodynamic results at three years, lower cost,

and elimination of the need for thoracotomy suggest that

PTMV should be considered for all patients with favorable

mitral-valve anatomy.

Mechanism of PTMV

PTMV relieves mitral stenosis by

splitting fused commissures,

similar to surgical

commissurotomy

PTMV Technique

Transseptal antegrade approach

Double balloon technique

Inoue balloon technique

Multitrack

Cribie dilator

Retrograde approach

Double Balloon Technique

Inoue Balloon

Kanji Inoue performed first PTMV with the eponymous balloon in 1984

FDA approved in 1994

Inoue Balloon Stages

Transeptal TEE/ICE

RHEUMATIC MITRAL STENOSIS post

RHEUMATIC MITRAL STENOSIS post

RHEUMATIC MITRAL STENOSIS ASD

Define success

▪ MVA >2 cm2 or

▪ MV gradient <5 mmHg

▪ Others markers:

50% improvement in valve area

MVA increased to >1 cm2/m2 BSA

STOP when increase in MR by ONE grade (1-4)

Inoue Balloon Stepwise Technique

Feldman et al. Cath CV Diag 28: 199, 1993

Min

ute

Inoue vs Double Balloon

Procedural time

0

15

60

45

30

75

90

Procedural time

Inoue Balloon Technique

Double Balloon technique

p<0.05

56

84

1525

Fluoroscopic time

Park SJ et al. Am J Coll 1993

Ev

ent-

free

surv

iva

l(%

)Event-free Survival

Death, MVR, redoPMV, NYHA≥3

83±5%

76±7%

p=NSInoue BalloonDouble Balloon

100

80

60

40

20

0

4 5 7620 1 3

YearsKang DH, et al J Am Coll Cardiol 2000

Complications of PTMV

• Mortality

• Systemic embolization

• Severe MR(+4)

• Left to right shunt (>1.5:1)

• Transient heart block and tamponade

• Hemopericardium

0-0.6%

0-4.5%

0.9-3%

<5%

<5%

0.5-5%

Contraindication of PMV

• Left atrial thrombus

• Apical LV thrombus

• MR>2+

• Bleeding diathesis

• Severe cardiothoracic deformity

Patient selection is

fundamental in predicting

outcome of PMV

Mitral valve morphology

Echocardiographic Score !!!

Echo Score

Mitral valve morphology

2 3

Rigidity

Thickening

Calcium

1

mobile valve

thin

no bright echos

4

immobile valve

severe thickening

multiple bright echo

Subvalvular sparse echos multiple thick chordae

apparatus

Mit

ral

Va

lve

Are

a(c

m2)

MVA according to ES

0

0.5

1.5

1

2

Pre-PMV

P<0.001

1.00.8

2.0

1.6

P<0.001ES ≤ 8 (n=601)

ES > 8 (n=278)

Post-PMV

Palacios Circulation 2002

80

60

40

20

0

100

86.5%

ES ≤ 8 (n=601)

76.6%

ES > 8 (n=278)Palacios Circulation 2002

P=0.0002

Success according to ES

Post-PMV MVA ≥ 1.5, 50% increase in MVA, MR ≤ 2+

%

Mit

ral

Va

lve

Are

a(c

m2)

Su

cces

s(%

)

1.5 1.4

0.7

Changes in MVA & Success

0

0.5

3

2.5

2

1.5

1

0%

10%

90%

80%

70%

60%

50%

40%

30%

20%

87%

2.2

1

Pre-PMV

Post-PMV

59%50%

1.6

29%

0.8 0.8

67% 68%

1.8 1.8

0.9 0.9

80%

1.9

0.9

80%

2.1

1

90%

2.2

1

4 5 6 7 8 9 10

Echocardiographic score11 12

2

1

0

4

3

5

Death MVRTamponade

P<0.006

P=NSP=NS

0.8

4.3

1 1

%

2.2

5.7

2.1

1.3

StrokePalacios Circulation 2002

In-Hospital Events

ES ≤ 8 (n=601)

ES > 8 (n=278)

P=0.0076

Su

rviv

al

(%)

Survival according to ES

100

80

60

40

20

0

0 20 40 60 80 100 120 140 160 180

Echo Score ≤ 8

Total Group

Echo Score > 8

P<0.001

Time of Follow-up (months)

Palacios Circulation 2002

Su

rviv

al

(%)

Event-Free Survival

according to ES

100

80

60

40

20

0

0 20 40 60 80 100 120 140 160 180

Death, MVR, redoPMV

P<0.0001

Echo Score ≤ 8

Total Group

Echo Score > 8

Time of Follow-up (months)Palacios Circulation 2002

Su

rviv

al

(%)

Events according to ES

100

80

60

40

20

0

0 20 40 60 80 100 120 140 160 180

Death, MVR, redoPMV

P<0.0001

Echo Score ≤ 8

Echo Score 9 - 11

Echo Score ≥ 12

Time of Follow-up (months)Palacios Circulation 2002

Long-Term Events

Independent predictors; Redo MVP, MVR, Death

<0.00001

0.05

0.002

0.03

0.02

<0.00001

<0.00001

P

1.01-1.03

1.00-1.81

1.16-1.92

1.02-1.67

1.09-2.22

2.61-4.72

1.01-1.03

1.02

1.35

1.50

1.31

1.56

3.54

1.02

Age

NYHA IV

Prior commissurotomy

Echo score

Pre-PMV MR ≥ 2+

Post-PMV MR ≥ 3+

Post PMV Pul A pressure

CIORVariables

Palacios Circulation 2002

CONCLUSIONS

• PTMV is the procedure of choice the

treatment of patients with MS for optimal

candidates from morphologic and clinical points

• Immediate post-PTMV variables in conjunction

with pre-PTMV clinical and mitral morphologic

variables identify most likely to benefit long-term

Russell C Brock (1903-1980)

1948 – One of first four surgeons to operate on rheumatic mitral stenosis

Finger-fracture Valvuloplasty

(closed commissurotomy)

“the mitral valve was too calcified to permit dilation; immoderate enlargement of the mitral orifice might convert mitral stenosis into severe mitral regurgitation; and patients in whom mitral regurgitation was the chief problem were not candidates for the procedure”

CALCIFIC MITRAL STENOSIS

✓Not amenable to valvuloplasty

✓ Surgery is high risk

✓Would benefit from specialized mitral valve surgical expertise

RHEUMATIC MITRAL STENOSIS

2014 AHA/ACC Valve Disease Guidelines

Mitral Regurgitation

Normal leaflet

motion

Endocarditis

Dilated annulus

Atrial fibrillation

Restrictive CM

Excess leaflet

motion

Prolapse or flail

leaflet

MVP

Papillary rupture

Trauma

Endocarditis

Leaflet restriction

systole & diastole

Rheumatic

Carcinoid

SLE

Radiation

Drugs

Leaflet restriction

systole only

Ischemic Heart

disease

Dilated CM

Degenerative MR

Rheumatic changes

Annular dilation

Functional MR

Annular Calcification

Pap muscle dysfxn: fixed or transient

Redundant Leaflets

Elongated or ruptured chords

Endocarditis

Mitral Regurgitation

Secondary MR

▪ Secondary MR (cf. primary)

▪ Functional MR (cf. degenerative)

▪ Ischemic MR (cf. Non-ischemic)

▪ MR that occurs in the setting of LV dysfunction with normal (or near normal) mitral leaflet and chordal structure

Degenerative Mitral Regurgitation

MR Pathophysiology

MR

Increase in LVEDV

Increase in total SV

Maintain

CO

LV dilatation

LV dysfxn CHF

LA dilatation

Atrial fibrillation

Rupture of chordae

Accelerated course

Pulm HTN

RV dysfxn

MR: classification of severity

MILD MOD SEVERE

Angiographic grade

1 + 2 + 3-4 +

Color Doppler jetarea

< 4 cm2 or < 20% LA

area

>40% LA area,Wall-impinging jet of any

size, swirling in the LA

Doppler vena contracta width

< 0.3 0.3 – 0.69 > 0.7

Regurgitantvolume (ml/beat)

< 30 30 - 59 > 60

Regurgitantfraction (%)

< 30 30 - 49 > 50

Regurgitantorifice area (cm2)

< 0.2 0.2 – 0.39 > 0.4

Mitral Valve Repair cf Replacement

▪ Preserves the native valve

and, almost always, the subvalvular apparatus

▪ Improved long-term survival

▪ Improved cardiac function

▪ Lower risk of complications (incl. stroke, SBE)

▪ Usually eliminates need for anticoagulants

Multiple surgical options

Full sternotomy Partial sternotomy

Right thoracotomy Robotic

All degenerative MR is repairable

▪ Create durable zone of coaptation Leaflet procedures

Mitral Ring Annuloplasty

All degenerative MR is repairable

▪ Quality of repair Degree of residual MR

▪ Durability of repair Rate of recurrent MR

Rate of reoperation

Added surgical bonus

▪ Concurrent revascularization

CABG

▪ AF-therapies

e.g. surgical Maze, left atrial appendage closure

Transcatheter Mitral Valve repair

▪ Mitral valve repair surgery remains optimal

▪ The only FDA-approved TMVr device is MitraClip

▪ Other approaches – leaflet tethering, transcatheter annuloplasty in development

Transcatheter Mitral Valve Replacement

▪ In development – FDA-approved clinical trials

▪ Deployment of artificial valve across native mitral to fix MR

▪ Trans-apical via left thoracotomy and transeptal

The MitraClip▪ The only FDA approved percutaneous therapy for Mitral

Regurgitation in the US

▪ Edge-to-edge repair (cf. Alfieri stitch)

Alfieri Ottavio. , De Bonis M. The role of the edge-to-edge repair in the surgical

treatment of mitral regurgitation, J Card Surg 2010, 25(5): 536-541.

Everest II Trial

Enrolled from 09-2005 to 11-2008, 37 centers US & Canada

• Primary Safety Endpoint:

• Rate of MAE at 30 d: composite of death, MI, reop for failed MV Surgery, non-elective CV surgery for adverse events, CVA, Ren Failure, deep wound infection, Vent for >48 hrs, GI complications req Surg, new afib, sepsis and transfusion ≥ 2 U blood

• Primary Efficacy Endpoint:

• Freedom from death, surgery for MV Dysfxn & grade 3+ to 4+ MR at 12 mo

Everest II Trial ▪ Grade 3+ to 4+ Chronic

MR

▪ Symptomatic: LVEF >25%, LVESD ≤55 mm

▪ Asymptomatic: LVEF 25-60%, LVESD 40-55 mm, New afib or PulmHypertension

▪ Were candidates for MVRepr or MVRepl

2:1 randomization

Conclusions

▪ MitraClip clearly reduces symptoms, although less than MVR in candidates who can have surgery

▪ MitraClip improves quality of life post procedure

▪ MitraClip is non-inferior to surgery in safety

▪ MitraClip 5 year results are durable

▪ MitraClip is reasonable for patients who are at prohibitive risk for surgery

Future of MitraClip

▪ COAPT: Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation

Case Presentation

▪ 96-year old woman

▪ Active until July 2016

▪ Developed worsening dyspnea

admitted to the hospital with congestive cardiac failure

Improved after introduction of the diuretics

▪ Severe AS and severe degenerative MR

Case Presentation

▪ 96-year old woman

▪ Active until July 2016

▪ Developed worsening dyspnea

admitted to the hospital with congestive cardiac failure

Improved after introduction of the diuretics

▪ Severe AS and severe degenerative MR

▪ Underwent TAVR but remained symptomatic with elevated pulmonary pressures

Results

▪ LVEF normalized

▪ No severe pulmonary hypertension

▪ No severe MR (reduced to mild)

▪ No severe AS

▪ Asymptomatic and independent (98 yrs. old)

• Patients with mitral valve disease are complex –

• symptoms may be multifactorial,

• require careful diagnostic workup,

• multidisciplinary approach,

• detailed stepwise treatment plan, and

• post procedure surveillance by dedicated teams.

Take home points

MS

• Transcatheter balloon mitral valvuloplasty is the preferred treatment option for patients with mitral stenosis and favorable anatomy.

MR

• Mitral Valve Repair surgery is the gold standard.

• MitraClip is approved for very high surgical risk patients with MR >3+ and degenerative mitral valve disease if reasonable survival expected.

• 5 year follow-up data show durable result. Landmark analysis shows after 6 months, event free survival improved.

• Ongoing trial for functional mitral regurgitation

Take home points

ECHO

CARDIO-PCP

InterventionalMS

TEE

PTBMV

Cardiac Surgeon

MV surgery

Unfavorable MS

ECHO

CARDIO-PCP

Cardiac SurgeonDMRTEE

MitraClip

Interventional

High-risk DMR

MV surgery

Medical ℞

MDT

ECHO

CARDIO-PCP

Cardiac SurgeonInterventionalMS

PTBMV MV surgery

TEE

Unfavorable MS

DMR

MitraClip

High-risk DMR

ECHO

CARDIO-PCP

Cardiac SurgeonInterventionalMS DMR

MDT

PTBMV MitraClip Medical ℞ MV surgery

TEE

Unfavorable MS High-risk DMR

Peacock Club – MDT approach 70 yrs ago

▪ Discussions of life threatening risks of the invasive investigations

▪ Shared management planning

▪ Self-critical reviews of operations that often went badly

Hearts of the patients who died were critically examined in the presence of the whole team

▪ Meticulous documentation of treated and untreated cases.

/interventions

(national registries – STS/ACC TVT)

MULTI-DISCIPLINARY APPROACH TO MITRAL DISEASE

Nikolaos Kakouros, MBBS MRCP PhD MD(Res) FACC FSCAI Director, Structural Heart Disease programProgram Director, Interventional Cardiology SHD FellowshipCo-director, TAVR programAssistant Professor of MedicineUniversity of Massachusetts Medical School

CARDIOLOGIST