CARDIOLOGY GRAND ROUNDS...•61 yo male •Father had MR and a mitraclip •Severe MR, bileaflet prolapse •38 Physio II ring repair ... ICU obs No ICU 0 20 40 60 80 100 Home discharge

C A R D I O L O G Y   G R A N D   R O U N D S  

Title:  Valvular Heart Disease at the Minneapolis Heart Institute: Practice and Innovation

Speaker:  Robert S. Farivar, MD, PhDChief, Cardiothoracic Surgery,  Abbott Northwestern Hospital Chairman, Allina Cardiothoracic;  Paul Sorajja, MD Director of the Center for Valve and Structural Heart Disease Mario Goessl, MD, FACC, FAHA, FESC, FSCAI  Interventional Cardiologist Minneapolis Heart Institute® at Abbott Northwestern Hospital 

Date:  Monday, March 14, 2016

Time:  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.  Describe the underserved population of patients with valvular heart disease. 2.  Recall indications and outcomes for minimally invasive valvular heart disease therapies. 3.  Recall current innovation trends in the surgical and catheter‐based therapy of valvular heart disease. 

Physician:  This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership 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 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.  

Nurse:  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.  

DISCLOSURE STATEMENTS  Speakers(s):  Dr. Farivar declares the following relationships; Consultant: Abbott Vascular, Edwards LifeSciences, LLC., & Medtronic. Dr. Sorajja declares the following relationships; Consultant & Speaker Bureau: Abbott Vascular; Consultant: Medtronic & Lake Region Medical. Dr. Goessl has declared that he does not have any conflicts of interest to disclose.  

Planning Committee  Dr. Michael Miedema, Dr. Scott Sharkey and Jolene Bell Makowesky have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. Robert Schwartz declared the following relationship ‐ consultant: Boston Scientific.  

PLEASE SAVE A COPY OF THIS FLIER AS YOUR CERTIFICATE OF ATTENDANCE 

   Signature: __________________________________________________________________________ 

My signature verifies that I have attended the above stated number of hours of the CME activity. 

Allina Health - Learning & Development - 2925 Chicago Ave - MR 10701 - Minneapolis MN 55407 

1

Grand Rounds: Mitral Update 2016

(Bileaflet and anterior leaflet prolapse)

Grand Rounds: Mitral Update 2016

(Bileaflet and anterior leaflet prolapse)

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

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

DisclosuresDisclosures

•Dr Farivar is a consultant to•Abbott Vascular•Edwards Lifesciences•Medtronic

•Dr Farivar is a consultant to•Abbott Vascular•Edwards Lifesciences•Medtronic

2

Cardiac Volumes at Abbott Northestern Hospital

Cardiac Volumes at Abbott Northestern Hospital

0

200

400

600

800

1000

1200

1400

1600

2013 2014 2015 2016

# Cases

# Cases

768

917

1061

1392

STS Mitral NumbersSTS Mitral Numbers

0

20

40

60

80

100

120

140

2013 2014 2015

Surgical Mitral Cases at Abbott

Repair Replacement Combined

3

Mortality from 2013 – 2015 in mitral repair

Mortality from 2013 – 2015 in mitral repair

•Zero

•Expected ~1%

•Thus Approximately 2 expected with none

•Zero

•Expected ~1%

•Thus Approximately 2 expected with none

Complexities of Valve SurgeryComplexities of Valve Surgery

Aortic Valve ReplacementAortic Valve Replacement Mitral Valve RepairMitral Valve Repair

Cessna Fighter Jet

4

ANATOMYANATOMY

What are the 5 parts of the mitral valve?

What are the 5 parts of the mitral valve?

•1. Leaflets (anterior and posterior)

•2. Annulus•3. Chordae•4. Papillary muscles•5. Ventricle

•1. Leaflets (anterior and posterior)

•2. Annulus•3. Chordae•4. Papillary muscles•5. Ventricle

5

Fibrous SkeletonFibrous Skeleton

6

AnnuloplastyAnnuloplasty

Suture placement

PATHOLOGYPATHOLOGY

7

Carpentier Mitral Functional Classification

Carpentier Mitral Functional Classification

•Based on an assessment of opening and closing motions of both leaflets

•Based on an assessment of opening and closing motions of both leaflets

Type 1- Normal Leaflet MotionType 1- Normal Leaflet Motion

- Annular Dilatation- Leaflet Defect - Annular Dilatation- Leaflet Defect

8

Type 2 – Leaflet ProlapseType 2 – Leaflet Prolapse

- Chordal rupture- Chordal elongation- Papillary muscle rupture

- Chordal rupture- Chordal elongation- Papillary muscle rupture

Type 3a – Restricted Leaflet MotionType 3a – Restricted Leaflet Motion

Valvular apparatus – systole and diastole

Valvular apparatus – systole and diastole

9

Type 3b – Restricted Leaflet MotionType 3b – Restricted Leaflet Motion

Ventricular - systoleVentricular - systole

Movement towards simplification

Movement towards simplification

10

Evolution, not revolutionEvolution, not revolution

(Semi) Rigid Complete Rings(Semi) Rigid Complete Rings

11

Case #1 – Early repair in my career: Very complicated

Case #1 – Early repair in my career: Very complicated

•65 y.o. male •Severe MR•Bileaflet prolapse•Repair with resection,

plication and neochordae•Early in my career, overly

complex

•65 y.o. male •Severe MR•Bileaflet prolapse•Repair with resection,

plication and neochordae•Early in my career, overly

complex

Case #1Case #1

12

Case #2Case #2

•36 y.o. police officer•Severe MR•Bileaflet prolapse:

Barlowe valve•Mini rt thor repair•Repair with upsized ring,

38 Physio II

•36 y.o. police officer•Severe MR•Bileaflet prolapse:

Barlowe valve•Mini rt thor repair•Repair with upsized ring,

38 Physio II

Pre Repair Post Repair

13

Follow Up…Follow Up…

Case #3Case #3

•53 yo Karate black belt and electrical engineer

•Bileaflet prolapse•Central to anteriorly

directed jet•Repair with 34 Physio II

•53 yo Karate black belt and electrical engineer

•Bileaflet prolapse•Central to anteriorly

directed jet•Repair with 34 Physio II

14

Pre Repair

Post Repair

Case #4Case #4

•65 yo yugoslavian male•Anterior leaflet prolapse,

ruptured chordae•Severe MR•Repair Goretex

neochordae anterior leaflet and 34 Physio II ring

•65 yo yugoslavian male•Anterior leaflet prolapse,

ruptured chordae•Severe MR•Repair Goretex

neochordae anterior leaflet and 34 Physio II ring

15

Case #4 - NeochordaeCase #4 - Neochordae

Pre Repair Post Repair

Case # 5Case # 5

•61 yo male•Father had MR and a

mitraclip•Severe MR, bileaflet

prolapse•38 Physio II ring repair•34 min XC•Contrast with case #1

•61 yo male•Father had MR and a

mitraclip•Severe MR, bileaflet

prolapse•38 Physio II ring repair•34 min XC•Contrast with case #1

16

Case #5Case #5

preop> 1year echo

Intraoperative

1

Valvular Heart Disease at MHI Practice and Innovation

Valvular Heart Disease at MHI Practice and Innovation

Paul Sorajja, MD

Director, Center for Valve and Structural Heart Disease

Minneapolis Heart Institute at Abbott Northwestern Hospital

Disclosures: Abbott Vascular, Medtronic, Lake Regions Medical, Boston Scientific

Paul Sorajja, MD

Director, Center for Valve and Structural Heart Disease

Minneapolis Heart Institute at Abbott Northwestern Hospital

Disclosures: Abbott Vascular, Medtronic, Lake Regions Medical, Boston Scientific

MHIF Grand Rounds 2016MHIF Grand Rounds 2016

Key PointsKey Points

• Transcatheter therapy is becoming safer

beyond high risk, and beyond aortic

• Transcatheter therapy is becoming safer

beyond high risk, and beyond aortic

Valvular Heart DiseaseValvular Heart Disease

• Despite advancements, valve population is at

risk, with huge unmet needs

a call to action is needed

• Despite advancements, valve population is at

risk, with huge unmet needs

a call to action is needed

• Minimally invasive surgery is the standard• Minimally invasive surgery is the standard

2

A Look Back into 2011A Look Back into 2011

PARTNER InoperablePARTNER Inoperable

p<0.0001p<0.0001

Standard RxStandard Rx

TAVITAVI

All-cause mortality (%)All-cause mortality (%)

MonthsMonths

00

2020

4040

6060

8080

100100

NNT to save one life: 5NNT to save one life: 5

50.750.7

30.730.7

Leon et al., NEJM 2010

3

16 procedures in one visit

BleedingStroke

PVL

Complications in vulnerable patients

The Present30-day outcomes for TF S3

The Present30-day outcomes for TF S3

0

2

4

6

8

10

HR IR

All-cause mortality

Cardiac mortality

1.6% and 1.1%

mortality

1.6% and 1.1%

mortality

Risks like

PCI

Risks like

PCI

PVL = 3.7%PVL = 3.7%

4

The Present14 Fr Evolut R CE mark

The Present14 Fr Evolut R CE mark

No procedural mortalityNo procedural mortality

Mod PVL = 3.4% (no severe) Mod PVL = 3.4% (no severe)

Repositioning = 25%Repositioning = 25%

Next Generation ValvesNext Generation Valves

Most 14 to 18 FrRepositionable, retrievable

Sealing skirt

Most 14 to 18 FrRepositionable, retrievable

Sealing skirt

5

Innovation in PracticeInnovation in Practice

0

1

2

3

4

5

6

Hospital LOS (d)

ICU obs

No ICU

0

20

40

60

80

100

Home discharge (%)

10000

12000

14000

16000

18000

20000

Variable Costs ($)

Skipping the ICU at ANWSkipping the ICU at ANW

Conscious SedationConscious SedationLess is MoreLess is More

0.5 mg midazolam50 mcg fentanyl

0.5 mg midazolam50 mcg fentanyl

Next dayNext day

6

DurabilityDurabilityPARTNER 5-yr Follow-UpPARTNER 5-yr Follow-Up

No. at Risk

HR [95% CI] =1.04 [0.86, 1.24]

p (log rank) = 0.76

TAVR 348 262 228 191 154 61

SAVR 351 236 210 174 131 64

62.4%

67.8%

Tie Goes to the Runner (?)Tie Goes to the Runner (?)

7

Waiting on the Science in TAVRWaiting on the Science in TAVR

HighHigh

IntermediateIntermediate

LowLow

Surgical riskSurgical risk

YesYes

This year (?)This year (?)

Trials soonTrials soon

IndicationIndication

Transcatheter MV RepairTranscatheter MV RepairMitraClipMitraClip

>30,000 ptsworldwide>30,000 ptsworldwide

8

STS = 10.0%Mortality: 2.3%Success: 91.8%

LOS: 3 days

STS = 10.0%Mortality: 2.3%Success: 91.8%

LOS: 3 days

MitraClip in the U.S.MitraClip in the U.S.

Sorajja et al. JACC 2016Sorajja et al. JACC 2016

9

Tertiary referrals Research Grants

MitraClip Training CenterMitraClip Training CenterMHI at Abbott Northwestern HospitalMHI at Abbott Northwestern Hospital

Basic and Advanced Live Case CoursesBasic and Advanced Live Case Courses

10

April 8, 2015April 8, 2015

First Transcatheter TMVR in U.S.First Transcatheter TMVR in U.S.

11

With all of these advances,

how are we doing?

With all of these advances,

how are we doing?

Population at RiskPopulation at Risk

True or False?True or False?

Survival of symptomatic AS is

worse than breast cancer

Survival of symptomatic AS is

worse than breast cancer

Johnstone PA, et al. J Surg Oncol 2000;73:273-7Johnstone PA, et al. J Surg Oncol 2000;73:273-7

AS is more malignant, yet treatableAS is more malignant, yet treatable

12

Population at RiskPopulation at Risk

How many patients with severe aortic

stenosis were evaluated at the

Minneapolis Heart Institute in 2015?

How many patients with severe aortic

stenosis were evaluated at the

Minneapolis Heart Institute in 2015?

a) 443

b) 928

c) 1,918

a) 443

b) 928

c) 1,918

Who are we responsible for?Who are we responsible for?

0

500

1000

1500

2000 2011

2012

2013

2014

2015

More than we thought, growing, and underservedMore than we thought, growing, and underserved

Annual Patients with Severe ASAnnual Patients with Severe AS

426 pts treated426 pts treated

1,918 pts seen

1,918 pts seen

13

Who are we responsible for?Who are we responsible for?

0

500

1000

1500

2000

2500

3000

3500

4000

4500 2011

2012

2013

2014

2015

2016

More than we thought, and growingMore than we thought, and growing

Annual patients with severe MRAnnual patients with severe MR

A disease with poor prognosis that is curable

A disease with poor prognosis that is curable

Vast majority not treatedVast majority not treated

We can do a lot betterWe can do a lot better

++

=

14

00

2020

4040

6060

8080

100100

00 55 1010 1515 2020 2525 3030 3535

Follow-up (mos)Follow-up (mos)

0

20

40

60

80

100

0 5 10 15 20 25 30 35

Follow-up (mos)

Guideline AdherenceGuideline Adherence

AdherentAdherent

Not adherentNot adherent

Survival free of death or HF hospitalizationSurvival free of death or HF hospitalization

p=0.02p=0.02

Asymptomatic severe ASAsymptomatic severe AS

Ahmed and Sorajja ACC 2016Ahmed and Sorajja ACC 2016

Best Practice AlertsBest Practice Alerts

15

Valve DashboardValve DashboardPopulation managementPopulation management

Patient-level, sortable dataPatient-level, sortable data

Who are my patients?Who are my patients?Demographics, Diagnosis, Treatment, CostsDemographics, Diagnosis, Treatment, Costs

16

Population MonitoringPopulation MonitoringSurvival with severe MRSurvival with severe MR

Population MonitoringPopulation MonitoringTiming IntervalsTiming Intervals

17

0

100

200

300

400

500

600

2011 2012 2013 2014

The HaloThe HaloAbbott Northwestern HospitalAbbott Northwestern Hospital

0

100

200

300

400

500

600

2011 2012 2013 2014

transcathetertranscatheter

surgical valve casessurgical valve cases

57

50

72

97

mitral repair surgerymitral repair surgery

Halo of Better OutcomesHalo of Better OutcomesAbbott Northwestern HospitalAbbott Northwestern Hospital

No AVRNo AVR AVRAVR

18

MHIF Valve Science CenterMHIF Valve Science CenterA Call to ActionA Call to Action

Mission

To study and develop methods of care that improve the health of patients with valvular disease

Mission

To study and develop methods of care that improve the health of patients with valvular disease

MHIF Valve Science CenterMHIF Valve Science CenterObjectivesObjectives

1. Study and gain insight into the barriers to care

2. Design, develop, and implement novel therapies and

care pathways

3. Expand the delivery of state-of-the-art care

4. Educate the public on the needs of this population

1. Study and gain insight into the barriers to care

2. Design, develop, and implement novel therapies and

care pathways

3. Expand the delivery of state-of-the-art care

4. Educate the public on the needs of this population

19

AwarenessAwareness

Staff and FundingStaff and Funding

ResearchResearch

MHIF Valve Science CenterMHIF Valve Science Center

Travel AwardsTravel Awards

KOL

Conference

KOL

Conference

Patient, MD Awareness CampaignPatient, MD Awareness Campaign

Valve Scholar ProgramValve Scholar Program

Trials, ISS StudiesTrials, ISS Studies

MHIF Valve Science CenterMHIF Valve Science CenterMajor Focus of 2016Major Focus of 2016

They need our support!They need our support!

20

2016 MHIF Gala Keynote Speakers2016 MHIF Gala Keynote Speakers

Mark KellyMark Kelly Scott KellyScott Kelly

Key PointsKey Points

• Transcatheter therapy is becoming safer

beyond high risk, and beyond aortic

• Transcatheter therapy is becoming safer

beyond high risk, and beyond aortic

Valvular Heart DiseaseValvular Heart Disease

• Despite advancements, valve population is at

risk, with huge unmet needs

a call to action is needed

• Despite advancements, valve population is at

risk, with huge unmet needs

a call to action is needed

• Minimally invasive surgery is the standard• Minimally invasive surgery is the standard

Help support the MHIF Valve Science Center!Help support the MHIF Valve Science Center!

1

Center for Valve and Structural Heart Disease

- Research Update -

Mario Gössl, MD, FACC, FAHA, FESC, FSCAIDirector Research and Education

March 14th2016

Overview• RESEARCH

– Ongoing trials• Mitral valve• Aortic valve

– Upcoming trials / registries / open access– Research projects

• EDUCATION– Publications/Presentations– Courses

2

Research

• Participating in 7 research trials• Participating in 2 open access registries• MHI V&SHD program has enrolled:

– 141 patients into trials– 30 patients into continued open access

MITRAL VALVE TRIALS

3

Ongoing trialsCOAPT

• Mitraclip® for FUNCTIONAL mitral valve regurgitation

• 1:1 randomization Mitraclip + optimal medical Tx vs. optimal medical Tx alone

• Enrollment #: 6

L-M

Ongoing trialsTENDYNE

• Tendyne Valve for functional or degenerative mitral valve regurgitation

• 4/8/2015 first transcatheter valve replacement in the US

• Enrollment #: 9 (2 April)Top enroller

4

AORTIC VALVE TRIALS/CAP

Ongoing trialsPORTICO

• St. Jude Medical TAVR for high risk patients (STS 8-15)

• 1:1 randomization Portico vs any commercially available TAVR valve

• Enrollment #: 3 (+2 in March)

L

5

Ongoing trialsLOTUS REPRISE

• Boston Scientific Lotus TAVR in high risk patients (STS 8-14)

• No randomization, now continued open access

• Enrollment #: 12 (Reprise 3) + 1

L-M

Ongoing trialsS3i CAP 2

• Edwards S3 TAVR for intermediate risk patients (STS 4-8)

• No randomization, open access• Enrollment #: 7

Edwards total # 78

H

6

Ongoing trialsSURTAVI

• Medtronic Evolute R, CoreValve TAVR in intermediate risk patients (STS 3-15)

• 1:1 randomization TAVR vs SAVR• Enrollment #: 11

M

Upcoming trialsREFLECT

• Keystone Heart, Cerebral protection by deflection device, no–research TAVR

• 2:1 Randomization• ? Reduction of cerebral embolic events

during TAVR, impact on cognitive function

• MRI / Neuro

7

Upcoming trialsLOW RISK TAVR

• Medtronic Evolute R, CoreValve 31• 1:1 randomization TAVR vs SAVR• Non-inferiority trial, safety and

effectiveness measured by all-cause mortality and disabling stroke at 2 years

Ongoing CVS trialsTRIFECTA & PERIGON

• Surgical bovine bioprostheses for AVR• St. Jude (TRIFECTA) long-term f/u• Medtronic (PERIGON) new solo implants• Enrollment #: 25 & 13

H

8

RESEARCH

• Active Intern Projects: 5• Fellow Projects: 4• Investigator led projects: 3• Completed projects that need to be

published: 20/22

Publications 2015-16

9

Publications 2015 - 16

• Manuscripts published: 6• Book chapters: 1• Manuscripts in submission: 3• Abstracts @ ACC ‘16: 5• Abstracts @ SCA ‘16: 7

Education

• MitraClip 101 and 202 courses (Abbott)• Dedicated transseptal access course

(Boston Scientific)• Structural Fellowship (1 fellow/year)

10

THANK YOUQuestions?

Valve QlikView (Dashboard)

• Outcomes Research (valvular heart disease)

• Economic analyses

11

UpcomingWatchman