cardiology grand rounds...•61 yo male •father had mr and a mitraclip •severe mr, bileaflet...
TRANSCRIPT
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
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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
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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
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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