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Minneapolis Heart Institute Foundation® Cardiovascular Grand Rounds Title: The intersection of heart failure and structural cardiology

Speaker(s): Peter Eckman, MD, FACC, FHFSA Section Head, Advanced Heart Failure, Minneapolis Heart Institute® at Abbott Northwestern Hospital Paul Sorajja, MD Director, Center for Valve and Structural Heart Disease Minneapolis Heart Institute® at Abbott Northwestern Hospital

Date: December 17, 2018 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 incidence of heart failure and valve disease. 2. Describe contemporary structural heart treatments that are pertinent for heart failure patients. 3. Identify patients that might be candidates for structural heart failure treatments.

ACCREDITATION Physician - Allina Health is accredited by the Accreditation Council for Continuing Medical Education (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 only claim 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 1.0 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education. DISCLOSURE POLICY & STATEMENTS Allina Health, Learning & Development intends to provide balance, independence, objectivity and scientific rigor in all of its sponsored educational activities. All speakers and planning committee members participating in sponsored activities and their spouse/partner are required to disclose to the activity audience any real or apparent conflict(s) of interest related to the content of this conference. The ACCME defines a commercial interest as “any entity” producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of clinical service is owned, or controlled by, an ACCME-defined commercial interest. Moderator(s)/Speaker(s) Dr. Peter Eckman has disclosed the following relationships: Honoraria (self): Abbott Vascular, Medtronic. Dr. Paul Sorajja has disclosed the following relationships: Abbott Vascular: research, consulting, speaking; Boston Scientific: research, consulting, speaking; Edwards Lifesciences: research, consulting speaking; Admedus: consulting; Medtronic: research, consulting, speaking.

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Planning Committee Dr. Alex Campbell, Jake Cohen, Jane Fox, Dr. Mario Gössl, Dr. Kevin Harris, Dr. Kasia Hryniewicz, Rebecca Lindberg, Amy McMeans, Dr. Michael Miedema, Dr. JoEllyn Moore, Pamela Morley, Dr. Scott Sharkey, and Jolene Bell Makowesky have disclosed that they DO NOT have any real or apparent conflicts with any commercial interest as it relates to the planning of this activity/course. Dr. David Hurrell has disclosed the following relationship –Boston Scientific: Chair, Clinical Events Committee.

NON-ENDORSEMENT OF COMMERCIAL PRODUCTS AND/OR SERVICES We would like to thank the following company for exhibiting at our activity.

Actelion Pharmaceutical Companies of Johnson & Johnson

Pfizer, Inc.

Accreditation of this educational activity by Allina Health does not imply endorsement by Allina Learning & Development of any commercial products displayed in conjunction with an activity. A reminder for Allina employees and staff, the Allina Policy on Ethical Relationship with Industry prohibits taking back to your place of work, any items received at this activity with branded and or product information from our exhibitors. PLEASE SAVE YOUR SERIES FLIER When you request a transcript this serves as your personal tracking of activities attended. Most professional healthcare licensing/certification boards will not accept a Learning Management System (LMS) transcript as proof of credit; there are too many LMS’s across the country and their validity/reliability are always in question. If audited by a licensing board or submitting for license renewal or certification renewal, boards will ask you not the entity providing the education for specific information on each activity you are using for credit. You will need to demonstrate that you attended the activity with a copy of your certificate/evidence of attendance, a brochure/flier and/or the conference handout. Each attendee at an activity is responsible for determining whether an activity meets their requirements for acceptable continuing education and should only claim those credits that he/she actually spent in the activity. Maintaining these details are the responsibility of the individual.

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MHIF CV Grand Rounds – Dec. 17, 2018

Integrating Heart Failure and Structural Cardiology

Peter Eckman, MD, FACC, FHFSA

Section Head – Advanced Heart Failure

Minneapolis Heart Institute

Disclosure InformationPeter Eckman, MD

Disclosure InformationPeter Eckman, MD

I have the following financial relationships to disclose:

Consultant for: Abbott, Medtronic

Advisory Board: Abbott, Medtronic

I WILL be discussing off‐label and investigational use.

All $$$ donated to Minneapolis Heart Institute Foundation

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77 year old man with exertional dyspnea

• Prior CAB, Parox AF (flutter ablation ‘13), HFpEF

• Sleeps a lot, can only walk 10‐20 feet (>1 mile 6 months ago)

• Aortic stenosis – moderate vs severe?

• PFTs reassuring, OSA on CPAP (religiously)

• BP 132/60, HR 51

• Meds: Amlodipine 5, HCTZ 25, Losartan 100, Metoprolol 50 bid, ASA/Warfarin/Rosuvastatin

• Labs: Na 140, BUN 28, Cr 1.2, Hgb 12.8

77 year old man with exertional dyspnea

• Echo: LVEF 45‐50%, grade 3 diastolic filling, elevated E/e;

• RV size normal, mild dysfunction• Ao AVA 0.82, mean gradient 12, peak 2.2 m/s, DI 0.21

• Angiography: patent grafts• AoV moderate stenosis• RHC:

– Baseline SBP 160 and PCWP 17– Arm exercise: SBP to 180 and PCWP to 27

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HFpEF Management Framework

• Consider uncommon etiologies (constriction, restrictive disease, amyloid, etc)

• Phenotype (exercise‐induced, PH, volume overload)• Address pertinent comorbidities

– CAD– Atrial fibrillation– Sleep disordered breathing– Anemia– Deconditioning/obesity

• Congestion management, including CardioMEMS, consider spironolactone

• Role of nitrates (NEAT‐HFpEF found worse exercise)• Consider clinical trials

Adamson PB et al, Circ Heart Failure 2014.

CardioMEMS in HFrEF/HFpEF

HFpEF

Low EF

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HFpEF

• Hallmark is effort intolerance

• Profound/brisk increase in LA pressure during exercise

• Lutembacher syndrome (1916)

– Combination of mitral stenosis and secundum ASD

– Originally described 1750 byJohann Friedrich Meckel, Sr.

Kaye D et al, J Card Fail 2014.

Actual

Simulated

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Rest Exercise

Kaye D et al, J Card Fail 2014.

HF Cardiologist on Valves

• Very common in HF patients (LV/RV/BiV)

• Outcomes with surgery in low LVEF poor

• Not infrequent to see patient who had MVsurgery ~6‐12 months ago who now needs aVAD/Transplant

• Meds will often make it better– Decongest, vasodilate, treat HF

• Spend more time on:– BB, ACEI/ARB/ARNI, AA, ICD, CRT, etc

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Medical Management of TR

• Preload

– Can be hard to optimize volume status – what isgoal? How to measure with pulsatile JVP?

• Afterload

– Pulmonary vasodilators expensive and off‐label

• Contractility

– Digoxin?

• Consider addressing anatomy/mechanical

Outcomes of Isolated TR

• 353 patients with isolated TR

• Age 70, 33% male, EF 63%, all with RVSP <50, noother valve disease >mild, no pacer/ICD wires

• Severe by ERO ≥ 40 mm2

• Difficult to study due to confounders, PH,left‐sided disease

• Independent or surrogate?

• Hard to assess, define severe TR

• Limited indications for isolated surgery, timing??

Topilsky Y et al JACC: Cardiovasc Imag 2014

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Survival by EROA in TR

Topilsky Y et al JACC: Cardiovasc Imag 2014

No difference if AF/SRNo difference if symptoms/not

TR associated with increase mortality independent of RVP and RV failure

• Systematic review of 70 studies with 32,601 patients

• Mean follow‐up 3.2±2.1 years

• Mod/sev associated with mortality risk 1.95 [1.75‐2.17]

All Cause Mortality

Wang N et al Eur Heart J 2018.

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Wang N et al Eur Heart J 2018.

TR in HFrEF – Long Term Outcomes• 3,943 patients

• All with LVEF <35%

• Age 69±14, 74% male

• Median follow‐up:– 8.1 years

• Excluded:– AS/AI > Moderate

– Mitral stenosis

– Valve replaced

Kazum SS et al Am J Med 2018.

Severity %Median

Survival (y)

Non‐signif 70% 4.9

Moderate 24% 2.3

Severe 6% 1.6

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Timing of surgical referral for ITVR

• All ITVS in France 2013‐2014 (84 repair 157 replacements)

• 61±16 years old, 53% women, 10% CAD, 26% CHF, 20% endocarditis, 10% renal failure

• In‐hospital mortality 10%

• Major complications 19% (death, dialysis, MV with ECMO)

• Hospitalization 26±40 days

• Do transcatheter options change timing?

Dreyfus J et al Am J Cardiol 2018.

The 2 times to fix the tricuspid valve

Too early

Too late

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Pagnesi M et al Int J Cardiol 2017.

Cardiac Death All‐cause mortality

Address TR with Left‐sided surgery?Meta‐analysis: 15 studies, 2840 patients

Outcome of MR

• 2000‐2010: 1,294 with mod/sev MR

• Median age 77, 42% with LVEF <50%

• Mean EROA (available in n=822) 0.25 cm2

• 51% CV death with RR 2.23 [2.06‐2.41]

• 64% with HF at 5 years

• Surgery in 15% (75% repairs) but only 5% of those with LVEF <50%

• Only ~25% with class I surgical indications had surgery

Dziadzko V et al Lancet 2018.

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Survival after isolated mod/sev MR

LVEF <50%

LVEF ≥50%

Dziadzko V et al Lancet 2018.

All Patients

Management/Outcomes of mod/sevFMR with severe HFrEF

• Mod/Severe FMR and severe HFrEF(EF ≤30% or LVESD >55 mm)

• 1,441 patients, median follow‐up 4.7 years• Median age 64, 39% women• Therapy:

– Medical therapy 75%– PCI 8%– CAB 6%– CAB/MV 7%– MV surgery alone 4%– Repair 143/151

Samad Z et al Eur Heart J 2015

ACC/AHA Guidelines

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Samad Z et al Eur Heart J 2015

Does medical therapy alter FMR?

• Extent of FMR at baseline and 50 months in 163 consecutive HFrEF patients– 31% with severe MR at baseline, 38% of those improved to nonsevere

– 18% nonsevere developed severe despite GDMT

• Sustained severe FMR or worsening FMR had OR 2.5 [CI 1.5‐4.3] for major AE’s

• LBBB and diabetes predictive of deterioration of MR

Nasser R et al JACC: HF 2017

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Evolution of MR in HFrEF

• 249 patients with HFrEF

• 19% had progression of MR

• Progression predicted mortality

– Uni: HR 2.33 [1.34‐4.08], p=0.003

–Multi: HR 2.48 [1.40‐4.39], p=0 .002

• Regression of MR was NOT associated with benefit

Bartko PE et al Eur Heart J: Cardiovasc Imag 2018.

Valsartan/sacubitril and FMR

• 118 HF with FMR randomized to valsartan/sacubitril vs valsartan

• Primary endpoint at 12 months change in EROA

• EROA ‐0.058±0.095 vs ‐0.018±0.105 cm2

p=0.032

• Regurg Vol: ‐7.3 [‐12.6 to ‐1.9]p=0.009

Kang DH et al Circulation 2018

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• ATTEND registry – 4842 patients with ADHF

• Association of FMR and all‐cause mortality and HF readmission, stratified by HFpEF/HFrEF

Kajimoto K et al Eur J Heart Fail 2016

HFpEF Low EF

Remodeling after MitraClip

Attizzani GF et al JACC: Cardiovasc Int 2015.

LVEF LVEDV

LA Vol LVESV

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One year remodeling (FMR and HFrEF)

• 41 patients• Rx w/ MitraClip• Median age: 77• LVEF 33±3%• CI 2.0±0.2• LVESD 50±2• Mean PA 37±3.1

Pleger SV et al Eur J HF 2013.

LVEF ≤ 30%

LVEFLA Vol LVESD

Do transcatheter therapies impact neurohormones?

• 21 patients with mR undergoing MitrClip

• Noradrenaline level – no change

• Sympathetic nerve activity – MSNA burst frequency from 130±78/min to 74±21/min

Öztürk C et al, JACC Cardiovasc Interv 2016.

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What about bivalvular FR?• 1021 consecutive HFrEF patients

– Median 62y, 80% male– 41% NYHA III and 17% NYHA IV– 34% CRT

• 32% had moderate/severe BVFR– 45% FMR, 35% FTR (in general)

• Severe BVFR with more symptoms, adverse remodeling, and NH activation

• Severe BVFR associated with excess mortality, independent of clinical and echo parameters, GDMT, and NH activation

• BVFR conveys deleterious impact of global regurgitation load on failing heart

Bartko PE et al, Eur Heart J 2018.


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Thank [email protected]

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The Intersection of Heart Failure and

Structural Heart Disease

The Intersection of Heart Failure and


Paul Sorajja, MDRoger L. and Lynn C. Headrick Family ChairValve Science Center Minneapolis Heart Institute Foundation Abbott Northwestern Hospital

Paul Sorajja, MDRoger L. and Lynn C. Headrick Family ChairValve Science Center Minneapolis Heart Institute Foundation Abbott Northwestern Hospital

MHIF Grand RoundsMHIF Grand Rounds

DisclosuresDisclosures

• Consulting or Advisory Board: Abbott Structural,

Admedus, Boston Scientific, Edwards Lifesciences,

Medtronic, Gore

• Research: Abbott Structural, Boston Scientific,

Edwards Lifesciences, Medtronic

• Speaking: Abbott Structural, Boston Scientific, Edwards

Lifesciences, Medtronic

• National P.I.: Tendyne in MAC, Alt-FLOW, TRILUMINATE

II Pivotal

• Consulting or Advisory Board: Abbott Structural,

Admedus, Boston Scientific, Edwards Lifesciences,

Medtronic, Gore

• Research: Abbott Structural, Boston Scientific,

Edwards Lifesciences, Medtronic

• Speaking: Abbott Structural, Boston Scientific, Edwards

Lifesciences, Medtronic

• National P.I.: Tendyne in MAC, Alt-FLOW, TRILUMINATE

II Pivotal

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Key PointsKey Points

• SHD therapy improves symptoms and saves

lives even in late HF stages



• Heart failure and SHD beget each other• Heart failure and SHD beget each other

• MHI and MHIF is leading the way for innovative

trials in these patients, and we need your help!



Heart Failure and Structural Heart DiseaseHeart Failure and Structural Heart Disease

Heart FailureHeart Failure

Valvular Heart Disease

Valvular Heart Disease

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Heart FailureHeart

Failure

A Different ParadigmA Different Paradigm

Aortic Stenosis PathophysiologyAortic Stenosis PathophysiologyA One-way HighwayA One-way Highway

Pressure hypertrophy

Pressure hypertrophy

AVR, curative?

AVR, curative?

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Aortic Stenosis and Heart FailureAortic Stenosis and Heart FailureAny Myocardial Disease is AdverseAny Myocardial Disease is Adverse

Baron SJ et al. J Am Coll Cardiol 2016;67:2349-68Baron SJ et al. J Am Coll Cardiol 2016;67:2349-68

11,292 TAVR

patients in TVT

11,292 TAVR

patients in TVT

Aortic Stenosis and Heart FailureAortic Stenosis and Heart Failure

Van Gils et al., J Am Coll Cardiol 2017;69:2383-92Dweck et al., J Am Coll Cardiol 2011Van Gils et al., J Am Coll Cardiol 2017;69:2383-92Dweck et al., J Am Coll Cardiol 2011

4 year death = 36%4 year death = 36%

TAVR Unload StudyTAVR Unload Study

600 patients Moderate ASLVEF <50%

TAVR vs. GDMT

600 patients Moderate ASLVEF <50%

TAVR vs. GDMT

LVEF <50% and Moderate ASLVEF <50% and Moderate AS

Poor SurvivalPoor Survival

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Aortic Stenosis and Heart FailureAortic Stenosis and Heart FailureMore Than Just EFMore Than Just EF

Cavalcante JL, JACC Cardio Intv 2016;9:399-405Cavalcante JL, JACC Cardio Intv 2016;9:399-405

Aortic StenosisAortic Stenosis

Replacement FibrosisReplacement Fibrosis AmyloidosisAmyloidosisInterstitial FibrosisInterstitial Fibrosis

PerfusionPerfusionVentricular FunctionVentricular Function

Classical Dogma of PathophysiologyClassical Dogma of Pathophysiology

Mitral RegurgitationMitral Regurgitation

“EF drops and patients can do worse.”“EF drops and patients can do worse.”

PreloadPreload AfterloadAfterload

Str

oke

Vo

lum

eS

tro

ke V

olu

me

MVRMVR MVRMVR

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Modern Experiences with TMVRModern Experiences with TMVRSevere LV dysfunction, no MRSevere LV dysfunction, no MR

EF = 30%EF = 30% EF = 20%EF = 20%

Transcatheter MVRTranscatheter MVR

Sorajja P, et al. J Am Coll Cardiol [In press]Sorajja P, et al. J Am Coll Cardiol [In press]

17.2% 22.7% 27.1%34.6%34.0%

60.9%62.7% 60.0%

51.9%61.9%

18.4%13.3% 12.9% 11.5%

4.1% 3.4% 1.3% 1.9%

0%

20%

40%

60%

80%

100%

Baseline 1 mo 3 mo 6 mo 12 mo

Class I Class II Class III Class IV

N=97 N=87 N=75 N=70 N=52

First 100 Tendyne PatientsFirst 100 Tendyne Patients

No procedural deaths

30-day O/E = 0.76

87% NYHA I/II at 1-yr

KCCQ = +22 pts

No procedural deaths

30-day O/E = 0.76

87% NYHA I/II at 1-yr

KCCQ = +22 pts

Now in SUMMIT, U.S. pivotal trial

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Sorajja P et al. JACC Intv 2017

Severe Mitral Annular CalcificationSevere Mitral Annular CalcificationTendyne Early Feasibility StudyTendyne Early Feasibility Study

Nat’l Principal Investigators: Paul Sorajja, MD, Vinod Thourani, MDNat’l Principal Investigators: Paul Sorajja, MD, Vinod Thourani, MD

Enrolling Now!Enrolling Now!

79 year-old man on GDMT79 year-old man on GDMTSevere secondary MR, EF = 30%Severe secondary MR, EF = 30%

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Left atrial

pressure

Left atrial

pressure

Stone GW, et al. N Engl J Med 2018Stone GW, et al. N Engl J Med 2018

NNT = 3NNT = 3 NNT = 6NNT = 6

One of the lowest NNTs to save a life, everOne of the lowest NNTs to save a life, ever

MitraClip vs. GDMT for Secondary MRMitraClip vs. GDMT for Secondary MR

Cardiovascular Outcomes Assessment of

MitraClip Percutaneous Therapy (COAPT)

Cardiovascular Outcomes Assessment of

MitraClip Percutaneous Therapy (COAPT)

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The COAPT TrialThe COAPT TrialMR and HF beget each otherMR and HF beget each other

180

185

190

195

200

205

210

215

Baseline 12 months

GDMT

MitraClipL

VE

DV

(m

l)L

VE

DV

(m

l)

194 ±76194 ±76

196±69196±69

211±94211±94

192±77192±77

P<0.001P<0.001

8 cm8 cm 6.5 cm6.5 cm

35 year-old Woman, NYHA III35 year-old Woman, NYHA III

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Percutaneous Ventricular TherapyPercutaneous Ventricular Therapy

AccuCinchAccuCinch

“Thank you for saving my life..”

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ACCUCINCH Trials at MHIFACCUCINCH Trials at MHIF

Percutaneous Ventricular TherapyPercutaneous Ventricular Therapy

AccuCinch EFS• LV dysfunction with moderate or severe MR

CorCinch – HFrEF• NYHA III with LVEDD >55 mm, EF 20 to 40%

CorCinch - PMVI• Secondary MR with prior failed surgery or MC

AccuCinch EFS• LV dysfunction with moderate or severe MR

CorCinch – HFrEF• NYHA III with LVEDD >55 mm, EF 20 to 40%

CorCinch - PMVI• Secondary MR with prior failed surgery or MC

82 year-old Woman with TR82 year-old Woman with TR

10-year survival, 14%10-year survival, 14%

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A Natural History Construct for TRA Natural History Construct for TR

ModerateModerateSevereSevere

Su

rviv

al a

nd

Sx

Su

rviv

al a

nd

Sx

YearsYears

Very steep both ways

Very steep both ways

Years of indolenceYears of indolence

RV failure, a late phenomenon

RV failure, a late phenomenon

MassiveMassive

TorrentialTorrential

Impairment already

Impairment already

Proprietary and confidential — do not distribute

TRILUMINATE EFS KCCQ at 30 days (n=60)

TRILUMINATE EFS KCCQ at 30 days (n=60)

23

55.7 54.7 56.175.1 64.7 73.6

20

30

40

50

60

70

80

90

100

3 (Severe) 4 (Massive) 5 (Torrential)Baseline TR Severity

Baseline 30 Day

50% with still severe TR

BUTKCCQ still 15 points better

50% with still severe TR

BUTKCCQ still 15 points better

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TRILUMINATE II U.S. Pivotal Study for TR

TRILUMINATE II U.S. Pivotal Study for TR

National Principal InvestigatorsPaul Sorajja, MD and David Adams, MD

Tri-Clip vs. Medical TherapyLaunch Q2 2019

National Principal InvestigatorsPaul Sorajja, MD and David Adams, MD

Tri-Clip vs. Medical TherapyLaunch Q2 2019

Unexplained Dyspnea EvaluationUnexplained Dyspnea Evaluation

PCWP = 39PCWP = 39

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Atrial Shunting for Heart FailureAtrial Shunting for Heart Failure

CorviaCorvia V WaveV Wave

8 mm diameter8 mm diameter 5 mm valve5 mm valve

Both ↓ exercise PCWPBoth ↓ exercise PCWP

Atrial Shunting for Heart FailureAtrial Shunting for Heart Failure

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Alt-FLOW Early Feasibility StudyAlt-FLOW Early Feasibility Study

• Ambulatory HFpFEF or HFrEF

• PCWP >15 at rest or >25 at exer.

• Stable GDMT >4 weeks

• No significant valve disease

• Ambulatory HFpFEF or HFrEF

• PCWP >15 at rest or >25 at exer.

• Stable GDMT >4 weeks

• No significant valve disease

Multicenter Study of ROOT DeviceNational Principal Investigator: Paul Sorajja, MD

Multicenter Study of ROOT DeviceNational Principal Investigator: Paul Sorajja, MD

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Key PointsKey Points





• Heart failure and SHD beget each other• Heart failure and SHD beget each other





Heart Failure and Structural Heart DiseaseHeart Failure and Structural Heart Disease

Thank you!

[email protected]

Tel: 507-513-1357

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MitraClip Trials for Secondary MRMitraClip Trials for Secondary MR

73739595

7070

3131 3333

7272

31314141

135135101101

Age (yr)Age (yr)

EF (%)EF (%)

LVEDVI (ml/m2)LVEDVI (ml/m2)

ERO (cm2)ERO (cm2)

Implanted (%)Implanted (%)

Stone GW, et al. N Engl J Med 2018; Obadia JF et al. N Engl J Med 2018Stone GW, et al. N Engl J Med 2018; Obadia JF et al. N Engl J Med 2018

==

==

<<

>>

>>

Aortic Stenosis and Heart FailureAortic Stenosis and Heart FailureParadoxical LFLGSASParadoxical LFLGSAS

Better with AVR, but remain at risk

Better with AVR, but remain at risk

“Normal” EFLVH, small LV

Low SVHTN

“Normal” EFLVH, small LV

Low SVHTN

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