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C A R D I O L O G Y G R A N D R O U N D S Presentation: Mitral Disease

Speakers: Robert S. Farivar, MD, PhD Chief, Cardiothoracic Surgery, Abbott Northwestern Hospital Chairman, Allina Cardiothoracic; Minneapolis Heart Institute® at Abbott Northwestern Hospital

Paul Sorajja, MD Director of the Center for Valve and Structural Heart Disease Minneapolis Heart Institute ® at Abbott Northwestern Hospital

Date: Monday, April 20, 2015, 7:00 – 8:00 AM Location: ANW Education Building, Watson Room

OBJECTIVES At the completion of this activity, the participants should be able to:

1. Recognize various quality metrics for mitral disease 2. Identify various minimally invasive incisions. 3. Identify what cases may be appropriate for referral for mitraclip.

ACCREDITATION Physicians: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Allina Health and Minneapolis Heart Institute Foundation. Allina Health is accredited by the ACCME to provide continuing medical education for physicians.

Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Nurses: This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.2 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education.

Others: Individuals representing other professional disciplines may submit course materials to their respective professional associations for 1.0 hours of continuing education credit.

DISCLOSURE STATEMENTS Speaker(s): Dr. Farivar declares the following relationship; Consultant: Edwards LifeSciences, LLC. Dr. Sorrajja declares the following relationships; Consultant & Speaker Bureau: Abbott Vascular; Consultant: Medtronic; Consultant: Lake Region Medical.

Planning Committee: Dr. Michael Miedema, and Eva Zewdie have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. Robert Schwartz declared the following relationships - stockholder: Cardiomind, Interface Biologics, Aritech, DSI/Transoma, InstyMeds, Intervalve, Medtronic, Osprey Medical, Stout Medical, Tricardia LLC, CoAptus Inc, Augustine Biomedical; scientific advisory board: Abbott Laboratories, Boston Scientific, MEDRAD Inc, Thomas, McNerney & Partners, Cardiomind, Interface Biologics; options: BackBeat Medical, BioHeart, CHF Solutions; speakers bureau: Vital Images; consultant: Edwards LifeSciences.

1

Mitral RegurgitationMitral Regurgitation

Paul Sorajja, MDDirector, Center for Valve and Structural Heart DiseaseMinneapolis Heart Institute at Abbott Northwestern Hospital

Paul Sorajja, MDDirector, Center for Valve and Structural Heart DiseaseMinneapolis Heart Institute at Abbott Northwestern Hospital

Robert S. Farivar, MD PhDChairman, Cardiac SurgeryMinneapolis Heart Institute at Abbott Northwestern HospitalChair, Allina Health Cardiac Surgical Services

Robert S. Farivar, MD PhDChairman, Cardiac SurgeryMinneapolis Heart Institute at Abbott Northwestern HospitalChair, Allina Health Cardiac Surgical Services

62 year-old man, asymptomatic62 year-old man, asymptomatic

a) Observe

b) Mitral valve replacement

c) Mitral valve repair

d) Transcatheter MitraClip

a) Observe

b) Mitral valve replacement

c) Mitral valve repair

d) Transcatheter MitraClip

2

Key PointsKey Points

• Highly prevalent disease that is under-treatedExcess mortality from treatment delays

• Success of mini-MV repair is >90% with risk of <1% and minimal LOS

• MitraClip indicated for high-risk patients Success >90% in selected patients

3

Prevalence of Mitral RegurgitationPrevalence of Mitral RegurgitationAge-dependentAge-dependent

Nkomo et al. Lancet, 2006; 368: 1005-11.

6% for ≥65 year olds

14

12

10

8

6

4

2

0

Pre

vale

nce

(%

)

Aortic valve disease

Age (years)

<45 45-54 55-64 65-74 >75

Mitral valve disease

All valve disease

3

Classification of MRClassification of MR

Sorajja, Paul, MD; Abbott Northwestern Hospital

Primary

“The Valve”

Secondary

“The Ventricle”

Usually myxomatous Ischemic or not

Key Prognostic DeterminantsKey Prognostic Determinants

Severity

Left Ventricular Function

Symptoms

4

6

Asymptomatic Primary MRAsymptomatic Primary MRSeverity and SurvivalSeverity and Survival

Enriquez-Sarano M et al. NEJM 2005;352:875-83Enriquez-Sarano M et al. NEJM 2005;352:875-83

Worse Survival

100

90

80

70

60

50

0

100

90

80

70

60

50

0

Su

rviv

al (

%)

Su

rviv

al (

%)

YearsYears

0 1 2 3 4 50 1 2 3 4 5

P<0.01P<0.01

ERO <20mm2 (91 ±3%)ERO <20mm2 (91 ±3%)

ERO 40mm2 (58 ±9%)ERO 40mm2 (58 ±9%)

ERO 20-39mm2

(66 ±6%)ERO 20-39mm2

(66 ±6%)

Worse Survival

100

90

80

70

60

50

0

Su

rviv

al (

%)

Years

0 1 2 3 4 5

P<0.01

ERO <20mm2 (91 ±3%)

ERO 40mm2 (58 ±9%)

ERO 20-39mm2

(66 ±6%)

More CV Events

70

60

50

40

30

20

10

0

70

60

50

40

30

20

10

0

Rat

e o

f C

ard

iac

Eve

nts

%R

ate

of

Car

dia

c E

ven

ts %

YearsYears

0 1 2 3 4 50 1 2 3 4 5

P<0.01P<0.01

ERO <20mm2 (15 ±4%)ERO <20mm2 (15 ±4%)

ERO 20-39mm2

(40 ±7%)ERO 20-39mm2

(40 ±7%)

ERO 40mm2 (62 ±8%)ERO 40mm2 (62 ±8%)

More CV Events

70

60

50

40

30

20

10

0

Rat

e o

f C

ard

iac

Eve

nts

%Years

0 1 2 3 4 5

P<0.01

ERO <20mm2 (15 ±4%)

ERO 20-39mm2

(40 ±7%)

ERO 40mm2 (62 ±8%)

EF and Surgical OutcomeEF and Surgical Outcome

100

80

60

40

20

0

Su

rviv

al %

Years

0 1 2 3 4 5 6 7 8 9 10

EF 60%

EF 50-60%

EF <50%

P=0.0001

72 ±4%

53 ±9%

EF <60% is Abnormal in MR

32 ±12%

Enriquez-Sarano M, et al., Circulation 1994;90:830-837

5

LV Function in MRLV Function in MR

Preload

Myocardial performance

Afterload

EF usually drops after surgery

MVR

MVR

9

Symptoms and SurgerySymptoms and SurgeryOutcome with Primary MROutcome with Primary MR

100

80

60

40

20

0

Su

rviv

al %

Years

0 1 2 3 4 5 6 7 8 9 10

NYHA I-II

NYHA III-IV

P<0.0001

90 ±276 ±5

73 ±3

48 ±4

Tribouilly CM et al., Circulation 1999;99:400-5

6

10

Flail Mitral LeafletFlail Mitral LeafletNatural HistoryNatural History

Ling L, et al. N Engl J Med 1996; 335:1417-1423Ling L, et al. N Engl J Med 1996; 335:1417-1423

100

80

60

40

20

0

100

80

60

40

20

0

Su

rviv

al %

Su

rviv

al %

Years After DiagnosisYears After Diagnosis

0 1 2 3 4 5 6 7 8 9 100 1 2 3 4 5 6 7 8 9 10

P<0.001P<0.001

Class I or IIClass I or II

Class III or IVClass III or IV

Mortality4% per yearMortality4% per year

34% per year34% per year

11

• Papillary muscle displacement

Trichon BH, et al. Am J Cardiol 2003;91:538-43

A Ventricular ProblemA Ventricular Problem

Regional or Global Dysfunction

• Annular flattening

• Leaflet tethering

Secondary Mitral Regurgitation

7

12

MR and Heart FailureMR and Heart FailurePrevalence in CHFPrevalence in CHF

Moderate or severe MR present in

40%

4 million people with heart failure and MR in U.S.

Patel JB, et al. J Card Fail 2004;10:285-291; Go AS, et al. Circulation 2013;127:e6.

0

10

20

30

40

50

60

70

%

None

Moderate

Mod-Severe

Severe

Advanced Heart Failure

13

Secondary Mitral RegurgitationSecondary Mitral RegurgitationA Harbinger of Poor OutcomeA Harbinger of Poor Outcome

Two-fold Increase Risk of DeathGrigioni F, et al. Circulation 2001;103:1759-64; Basket JF, et al. Can J Cardiol 2007;23:797-800

1.0

0.8

0.6

0.4

0.2

0.0

Su

rviv

al (

%)

Years

0 1 2 3 4 5

P<0.001

50

40

30

20

10

0

Dea

th o

r h

eart

fai

lure

h

osp

ital

izat

ion

%

Follow-up time (days)

0 365 730 1095

P=0.0006

MI w/o MR

MI with MR61 ±6

38 ±5

MitralRegurgitation

No Mitral Regurgitation

Post-MI SOLVD (EF >35%)

8

What about therapy?

Mitral RegurgitationMitral Regurgitation

General Principles of TherapyGeneral Principles of Therapy

Primary

Surgery for symptoms or LV

dysfunction

Secondary

Try to repair

Medical therapy first

No medical option

Consider CRT

Surgery only in highly selected patients with HFConsider

prophylactic repair

9

16

Timing of Surgical InterventionTiming of Surgical InterventionACC/AHA Guidelines – Primary MRACC/AHA Guidelines – Primary MR

Consider surgery whenSymptomsor

LV dysfunction (EF<60%, ESD≥40 mm)

Try to repair in a experienced center

Nishimura R, et al., J Am Coll Cardiol 2014;63:2438-88

17

Early Surgery Is BetterEarly Surgery Is BetterPatients without Class I IndicationsPatients without Class I Indications

100

80

60

40

20

0

Su

rviv

al %

Follow-up, y

0 5 10 15 20

Suri R et al., JAMA 2013;310:609-16

Early surgery

Medical management

Log-rank P<.001

10

Based on Patient RiskBased on Patient Risk

Surgery MitraClip

What Therapy for Primary MR?What Therapy for Primary MR?

Not High High

Mitral Valve SurgeryMinneapolis Heart Institute

Abbott Northwestern Hospital

Mitral Valve SurgeryMinneapolis Heart Institute

Abbott Northwestern Hospital

Mitral RegurgitationMitral Regurgitation

11

Nishimura RA, et al. JACC 2014

• Multidisciplinary

• Guideline adherence

• All therapy options

• Quality improvement

• Public reporting

2014 Valve Guidelines2014 Valve GuidelinesValve Center of ExcellenceValve Center of Excellence

Carpentier Principles of MVP(How we do mitral repair)

Carpentier Principles of MVP(How we do mitral repair)

• 1. Smooth Coaptation surface

• 2. Reduced height of posterior leaflet

• 3. Annuloplasty reinforcement

• 1. Smooth Coaptation surface

• 2. Reduced height of posterior leaflet

• 3. Annuloplasty reinforcement

12

Why we do mini mitral repairWhy we do mini mitral repair

Mini Mitral IncisionsMini Mitral Incisions

Paramedian

Lower hemi

Mini thoracotomy

Full sternotomy (small incision)

13

Lower hemisternotomy mitralLower hemisternotomy mitral

Lower hemisternotomy mitralLower hemisternotomy mitral

14

Port access mitralPort access mitral

Port Access VideoPort Access Video

15

Port Access PicturesPort Access Pictures

SINGLE SURGEON EXPERIENCESINGLE SURGEON EXPERIENCE

16

Mitral Valve Cases performed by Dr Farivar over initial 10 months

41

Mitral Valve Cases performed by Dr Farivar over initial 10 months

41

DemographicsDemographics

• Average age• Average XC• Average CPB• Male:Female

• Average age• Average XC• Average CPB• Male:Female

• 64 yo• 66 min• 92 min• 22:19

• 64 yo• 66 min• 92 min• 22:19

17

Deaths = 0 (zero)Deaths = 0 (zero)

Permanent Strokes = 0 (zero)Permanent Strokes = 0 (zero)

18

MI/Reop for Bleed/Infections = 1 reop bleed (2.6%)

MI/Reop for Bleed/Infections = 1 reop bleed (2.6%)

Mitral Valve Repair (Intention to Treat)

27/28 (96% intention to treat)

Mitral Valve Repair (Intention to Treat)

27/28 (96% intention to treat)

19

Mitral Valve Replacement =13

(mechanical 4)(tissue 7)

Mitral Valve Replacement =13

(mechanical 4)(tissue 7)

Mean Diastolic Gradient (repairs) on pre-discharge echo

4 mm Hg

Mean Diastolic Gradient (repairs) on pre-discharge echo

4 mm Hg

20

Concomitant CasesConcomitant Cases

• Double valves (5/41) = 12%Aortic 1/41 (2.4%)Tricuspid 4/41 (9.8%)

• Ascending aortic replacement 2/41 (4.9%)

• Left atrial appendage ligation 8/41 (19.5%)

• PFO closure 3/41 (7%)• CABG 3/41 (7%)

• Double valves (5/41) = 12%Aortic 1/41 (2.4%)Tricuspid 4/41 (9.8%)

• Ascending aortic replacement 2/41 (4.9%)

• Left atrial appendage ligation 8/41 (19.5%)

• PFO closure 3/41 (7%)• CABG 3/41 (7%)

MinisMinis

• For single valve cases 13/24 are minimally invasive (54%) [over half minis]

Port are over half (8/13) Lead up time for ports, since team needed to be trained

• For single valve cases 13/24 are minimally invasive (54%) [over half minis]

Port are over half (8/13) Lead up time for ports, since team needed to be trained

21

Complexity/ComorbidityComplexity/Comorbidity

• Extreme Kyphoscoliosis 2/39 (5%)• Reoperations 4/39 (10%)• Re-repair failed repairs 2+ (5%)• IABP (low EF) 3/39 (8%)• Barlowe (bileaflet)/anterior leaflet prolapse 8/30

(27%), functional 3/39 (8%), posterior 22/30 (73%)• HIV/HepC/renal insufficiency/stoma 5/39 (13%)• Combined HOCM patients 2/39 (5%)• Endocarditis 2/39 (5%)• > 75 yo 10/39 (26%)

• Extreme Kyphoscoliosis 2/39 (5%)• Reoperations 4/39 (10%)• Re-repair failed repairs 2+ (5%)• IABP (low EF) 3/39 (8%)• Barlowe (bileaflet)/anterior leaflet prolapse 8/30

(27%), functional 3/39 (8%), posterior 22/30 (73%)• HIV/HepC/renal insufficiency/stoma 5/39 (13%)• Combined HOCM patients 2/39 (5%)• Endocarditis 2/39 (5%)• > 75 yo 10/39 (26%)

LOSLOS

•Overall LOS = 7d (all comers)

•Lower Hemi = 6d•Port Access = 5d

•Overall LOS = 7d (all comers)

•Lower Hemi = 6d•Port Access = 5d

22

AP PA

Complexity: Extreme Kyphoscoliosis Mitral Repai

AP PA

Complexity: Extreme Kyphoscoliosis Mitral Repai

23

24

Results: Mitral Regurg on Postop

Echo

Results: Mitral Regurg on Postop

Echo

0

5

10

15

20

25

None 1+ 2+ 3 or 4+

Number pts

Number pts

25

Financials at ANWFinancials at ANW

Mitral Repair

Mitral Replacement

26

Summary Data InsightsSummary Data Insights

•Selection of cases is appropriate

• Intraop decision making and clinical support is good

•Postoperative Care is appropriate

•Financial aspects extremely favorable

•Selection of cases is appropriate

• Intraop decision making and clinical support is good

•Postoperative Care is appropriate

•Financial aspects extremely favorable

Goals/Vision/FutureGoals/Vision/Future

• Reference CenterELS

• Mini growth• Help for other surgical

programs in system• Gets us the latest equipment

& Trials(Advantages of a reference center)

• Reference CenterELS

• Mini growth• Help for other surgical

programs in system• Gets us the latest equipment

& Trials(Advantages of a reference center)

27

Catheter-based Therapy for Mitral Regurgitation

Catheter-based Therapy for Mitral Regurgitation

Mitral RegurgitationMitral Regurgitation

MitraClip® SystemMitraClip® System

28

Suitable Anatomy?Suitable Anatomy?Clip openClip open Closed to 60Closed to 60

SpaceThick

leaflets, no Ca+2

helpful

SpaceThick

leaflets, no Ca+2

helpful

4 mm long≥2 mm tip coaptation

4 mm long≥2 mm tip coaptation

Grasping viewGrasping view

M vs LM vs L

Bi-com (60) and LVOT (150)Bi-com (60) and LVOT (150)EchocardiographyEchocardiography

150150

6060

Tells You Where and How Many ClipsTells You Where and How Many Clips

29

Clip Like Alfieri StitchLess risk of chord entrapment

Surgery MitraClip

MitraClip CaseMitraClip Case

30

Post-Superior TransseptalPost-Superior Transseptal

Avoiding ASDAvoiding ASD

3.5 - 4.0 cm

3.5 - 4.0 cm

Loosen

Torque

ML

31

32

Commissures Can Be DoneCommissures Can Be Done

MAC is not an contraindicationMAC is not an contraindication

33

An Important TidbitAn Important Tidbit

August 2014August 2014 October 2014October 2014

PCIPCI

Remember how dynamic MR is

LAP = 13 with SBP at 150 mmHg

77 year-old man77 year-old man

34

Outcomes of the Initial Experience

with Commercial Transcatheter Mitral

Valve Repair in the U.S.

Outcomes of the Initial Experience

with Commercial Transcatheter Mitral

Valve Repair in the U.S.

ACC 2015 LBCT

Paul Sorajja, MD, Saibal Kar, MD, Amanda Stebbins, Sreekanth

Vemulapalli, MD, D. Scott Lim, MD, Vinod Thourani, MD,

Michael Mack, MD, David R. Holmes, Jr., MD,

Wesley A. Pedersen, MD, and Gorav Ailawadi, MD

A report from the STS/ACC TVT RegistryA report from the STS/ACC TVT Registry

Study Population564 Patients

Study Population564 Patients

• Median age (% men)…………………..…..

• NYHA III/IV……………………………….……….

• HF hospitalization prior yr…………….……....

• Atrial fibrillation………………………….……...

• Prior CVA………………………………….………

• Diabetes………………………………….……….

• Prior CABG……………………………….………

• Prior MI…………………………………………...

• Creatinine ≥2 g/dl……………………………….

• O2-dependency………………………….………

• Median STS-PROM MV repair..............…

• Median STS-PROM MV replacement.….

83 yrs (56%)

83.9%

51.8%

62.6%

8.7%

25.0%

32.4%

24.6%

16.7%

14.7%

7.9% (4.7, 12.2)

10.0% (6.3, 14.5)

35

0%

20%

40%

60%

80%

100%

Baseline Post-implant

Grade 4

Grade 3

Grade 2

Grade 1

Mitral Regurgitation

Change in Mitral RegurgitationChange in Mitral RegurgitationClip implantation occurred in 94%

93% MR ≤2

63.7% MR≤1

p<0.001

Clinical OutcomesClinical Outcomes

• In-hospital mortality…

• Procedure success….

• Complications............

• Length-of-stay............

• Home discharge.........

2.3%

91.8%

7.8%

3 d (1,6 d)

81.9%

36

U.S. vs. Other RegistriesU.S. vs. Other Registries

• STS/ACC TVT (US)...…….

• SENTINEL (EU)….………..

• ACCESS (EU)….……...….

• TRAMI (DE)………..………

• MitraSwiss (CH)................

• France (FR)……................

• GRASP (IT)……..….…….…

• Netherlands (NL)…………

• MARS (Asia)………………

93%

95%

91%

95%

85%

88%

100%

93%

94%

MR ≤2DMR In-hospital

death

2.3%

2.9%

2.9%

4.0%

3.3%

4.2%

Age (yrs)

83

74

74

75

77

73

72

73

71

86%

28%

23%

29%

38%

23%

24%

18%

46%• EVEREST I………………..

• EVEREST II RCT…...….…

• EVEREST II HRS……......

71

67

76

74%

77%

86%

0.9%

1.1%

2.6%

79%

51%

30%

A New Mitral TherapyA New Mitral Therapy

TendyneTendyne

37

April 8, 2015April 8, 2015

38

Key PointsKey Points

• Highly prevalent disease that is under-treatedExcess mortality from treatment delays

• Success of mini-MV repair is >90% with risk of <1% and minimal scars and LOS

• MitraClip indicated for high-risk patients Success >90% in selected patients