prelude - minneapolis heart institute foundation...the safety and performance of transcatheter...

Prelude

• CONDITION: Valvular Heart Disease

• PI: Mario Goessl, MD

• CONTACT INFO: Sara Olson | [email protected] | 612-863-37601

• DESCRIPTION: This is a prospective, multi-center, single-arm, clinical feasibility study. The purpose of this study is to assessthe safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe symptomaticmitral regurgitation (MR).

• CRITERIA LIST/ QUALIFICATIONS:Severe MR (grade 3 or 4) as determined by echocardiogramHigh Surgical risk as determined by the Heart TeamEF > 25% by echoNYHA II, III, IV

• SPONSOR: Caisson Interventional, LLC.

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M H I F C A R D I O L O G Y G R A N D R O U N D S Title: Disparities in structural heart disease (SHD)

Speaker: Mario Goessl, MD, PHD, FACC, FAHA, FESC, FSCAI Director of Research & Education of the Center for Valve & Structural Heart Disease Minneapolis Heart Institute Foundation® Director of the Watchman LAAC program; Program Director of the Interventional Cardiology & Advanced Adult Structural & Congenital Heart Disease Interventions Fellowship Minneapolis Heart Institute® at Abbott Northwestern Hospital

Date: February 12, 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 current disparities and reasons for them in SHD in the US. 2. Describe the goals of TVINCITIES, an investigator initiated research (IIR) from MHI/MHIF (PI Goessl). 3. Conduct further IIRs investigating Disparity in other parts of US cardiac healthcare.

ACCREDITATION 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 1.0 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education.

DISCLOSURE STATEMENTS Speaker Dr. Mario Goessl has disclosed that he does not have a conflict of interest in making this presentation.

Planning Committee Dr. Alex Campbell, Jake Cohen, Jane Fox, Dr. Mario Goessl, Dr. Kevin Harris, Dr. Kasia Hryniewicz, Rebecca Lindberg, Amy McMeans, Dr. Michael Miedema, Dr. JoEllyn Moore, Pamela Morley, Laura Onstot, 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. David Hurrell declares the following relationship –Boston Scientific: Chair, Clinical Events Committee.

We gratefully acknowledge the following organizations for their commercial support for this activity. Janssen Pharmaceutical Companies of

Johnson & Johnson Pfizer

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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MHIF CV Grand Rounds Feb. 12, 2018

Racial / Ethnic Disparities in Structural Heart Disease Interventions

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

Watchman Program & Structural / Interventional Cardiology Fellowships

TVINCITIESaorTic Valve dIsease aNd raCIal dispariTIES

“Healthcare disparities are differences in health care quality, access, and outcomes adversely affecting members of racial and ethnic minority groups and other socially disadvantaged populations”

Natl. Quality Forum. 2012. Healthcare disparities and cultural competency consensus standards. Quality Forum, Washington, DC

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Distribution of >average racial/ethnic minority populations

Morris AA et al., J Heart Lung Transplant 2016;35:953– 961

Preventable death rates

Ferdinand KC, J Clin Hypertens. 2017;19:1015–1024

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Source: U.S. Census Bureau; ESRI forecasts for 2015 and 2020

77.3%

4.8%7.7%6.2%4.0%

MN 2015

Other

Asian

Black

Hispanic

White

The US is projected to have amajority non-white Population

by 2050

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Socioeconomic and health insurance disparities

• 11% of Caucasians are uninsured, 31% for Native Americans and 32% for Hispanic Americans1

• Uninsured minorities <65 years unaware of eligibility of Medicaid and other programs2

1U.S. Census Bureau News2Going Without: America’s Uninsured Children

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Ox-VALVE-PCS

D’Arcy JL, European Heart Journal (2016) 37, 3515–3522

MitraClip Race/Ethnicity Breakdown 2017

88.5

6.9 5.52.5 0.5 0.4 0.2

98.3

0 0 0 1.3 03

0

20

40

60

80

100

120

Caucasian Black Hispanic Asian NativeAmerican

NativeHawaiian

Other

% MitraClip US

% MitraClip ANW

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Watchman – LAA occlusion

Boston Scientific, DFU

AVR Race/Ethnicity Breakdown 2017

87.3

5.5 6.8

1.5 0.4 0.23

94.7

03.5 3.5

1.8 0 00

10

20

30

40

50

60

70

80

90

100

Caucasian Black Hispanic Asian Native

American

Native

Hawaiian

Other

% AVR 2017 (STS)

% AVR ANW 2017

87.3

5.5 6.8

1.5 0.4 0.23

94.7

03.5 3.5

1.8 0 00

10

20

30

40

50

60

70

80

90

100

Caucasian Black Hispanic Asian Native

American

Native

Hawaiian

Other

% AVR 2017 (STS)

% AVR ANW 2017

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2016 TVT registry data

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Disease Prevalence

• AA are at increased risk for early onset aortic stenosis1

• Equivocal reporting on racial differences in prevalence of aortic stenosis

1Coffey S, JACC 2014

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Aranow et al., AJC 2001

F

M

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Progression of Aortic Stenosis

PRINCIPLES FOR UNDERSTANDING HEALTH CARE DISPARITIES

Fiscella K, Annu. Rev. Public Health 2016. 37:375–94

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• Minority race and ethnicity are associated with social disadvantage, particularly for groups historically subjected to slavery and forced relocation.

• Racism directed toward historically socially marginalized groups contributes to social disadvantage and worse health.

• Race and ethnicity are often associated with multiple other dimensions of social disadvantage, including:– limited English proficiency– residential segregation– limited education, lack of employment, debt– low health literacy and low numeracy, and – poverty


Cultural differences and lack of understanding

• Historical distrust in the medical community (e.g. Tuskegee syphilis experiments)

• High refusal rate of AVR1

• Lack of understanding of differences AVR vs. percutaneous TAVR

• Perception of being “too old” (60, 70 yo)• Group decisions vs. individual decisions2

1Minha S, CCI 20152Talcott JA, Cancer 2007

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• System failures– macro politics and policies– health systems– teamwork and care processes, and – clinician behavior

• Equity in health care implies health care is responsive to the unique needs, culture, and preferences of patients and families

• Equitable care is the hallmark of genuine patient centered care


Racial and Ethnic Disparities in the Quality of Health Care


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• Social disadvantage is associated with:– being uninsured, underinsured, and unable to

afford health care costs– geographic and structural barriers to health

care, particularly primary care– some practices don’t accept Medicaid – many US hospital systems operate dual

systems of care


Racial and Ethnic Disparities in the Quality of Health Care


ACA

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• Nearly half of Americans (47%) report that they could not cover an emergency expense costing $400 without selling something or borrowing money.


Yet, this amount represents less than one-third of the average health insurance deductible in 2015

• Cognitive processes– Reflexive decisions (”I never take a flue

shot”)– Habits– Explicit, deliberative, and effortful decision

making– Decision making is constrained by context,

including available resources, particularly affordability


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Choice of Hospital

Dimick et al., HEALTH AFFAIRS 32, NO. 6 (2013): 1046–1053

• Implicit bias can affect legislation, policies, allocation of resources within institutions

• Physicians’ implicit racial bias has been associated with:– less patient-centered communication and– less informed decision making with minority

patients– how much information a physician provides

to minority patients Fiscella K, Annu. Rev. Public Health 2016. 37:375–94

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Referral Disparity (AA)

Sleder A, J. Racial and Ethnic Health Disparities (2017) 4:1189–1194

• AA are less likely to:– be referred to Cardiology1

– accept an intervention– come for follow up

• AA are less likely to:– be referred to Cardiology1

– accept an intervention– come for follow up

• Differences between provider entities (Type I health care disparity)

• Differences within provider entities (Type II health care disparity)

• Minority medical patients continue to be cared for more often by trainees rather than by staff physicians within hospital systems


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• Clinician factors (type A disparity)– E.g. order for DVT prophylaxis ( mandatory

clinical decision support

• Patient factors (type B disparity)– Adherence ( eliminate certain co-

payments)

• Clinician–patient communication (type C disparity)


Patient communication

Ferdinand KC, J Clin Hypertens. 2017;19:1015–1024

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No-shows

Shimotsu S (HCMC), Journal of Primary Care & Community Health 2016, 7(1) 38–40

Instead of scheduling “routine” clinic follow up appt.:

- Walk-in access?- Home visits?- Electronic visits?

Instead of scheduling “routine” clinic follow up appt.:

- Walk-in access?- Home visits?- Electronic visits?

Re-Hospitalization

Minority populations (especially AA) have:

– higher rates of all-cause re-hospitalization – higher rates of all-cause re-hospitalisation

and higher hospitalization and re-hospitalization for potentially avoidable causes (CHF, asthma, diabetes, post-OP)


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How to Improve Medication Adherence

(1) patient engagement strategies(2) patient portals(3) smart apps and text messages(4) digital pillboxes(5) pharmacist-led engagement(6) cardiac rehabilitation(7) cognitive-based behavior

- motivational interviewing

• Type I Universal QI approaches coupled with adequate resources

• Type II Targeted QI informed by detailed analysis (type A, B and C)

• Sustainability depends on implementation factors (acceptability, adoption, appropriateness, feasibility, and cost), the level of integration into routine care, and continued organizational prioritization


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How to fix it …

• Ensuring equity requires systems that optimize the core elements of primary care:– accessibility, continuity, comprehensiveness,

coordination, and whole-person accountability, particularly informed and shared patient decision making.

• Requires sufficient investment in primary care to develop:– high-functioning culturally diverse,

multidisciplinary health care teams that are responsive to the medical, behavioral, and social needs and values of socially disadvantaged patients.


Racial / Ethnic Disparities in Structural Heart Disease Interventions

TVINCITIESaorTic Valve dIsease aNd raCIal dispariTIES

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The HEART TEAM Decision

Patient with Severe Aortic

Stenosis Identifiedby Referring

Physician

1Patient with Severe Aortic

Stenosis Identifiedby Referring

Physician

1

Patient Referred to TAVR

Valve Clinic

2

Patient Referred to TAVR

Valve Clinic

2

Additional Testing

Completed

3

Additional Testing

Completed

3

MultidisciplinaryReview and

Treatment Decisionby TAVR Heart

Team

4

MultidisciplinaryReview and

Treatment Decisionby TAVR Heart

Team

4

TreatmentDecision

Discussed withReferringPhysician

5TreatmentDecision

Discussed withReferringPhysician

5Devising a Treatment Plan is a Collaborative Process

Ultimate treatment choice is a collaborative decision between the

physicians, patient and patient’s family.

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TVINCITIES AIMSAim 1. Identify patients who did not receive guideline driven therapy for severe AS, offer visit with the heart-team and guideline-driven therapy (SAVR and TAVR pending heart team discussion).Educate referring (primary care, hospitalists) and specialty physicians (Cardiology, Interventional Cardiology, Cardiovascular surgery) in order to improve guideline adherence and referral for appropriate therapy.

Aim 2. Determine impact of comorbidities, race/ethnicity, language barriers/education and SES on disparities in care for those requiring surgical or transcatheter therapies. Patients as well as referring providers will be asked to answer/fill out a standardized questionnaire that addresses these questions (an interpreter will help as needed).

Aim 3. Compare outcomes between disparity groups (race/ethnicity, language barriers/education and SES) and whites (age/gender matched group of white/non-diverse patients treated with the Sapien S3 valve at MHI and/or patients from the PARTNER trial(s)) following transcatheter therapy.

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THANK YOU!

Questions?

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