ADVANCES IN CARDIAC SYMPTOM MANAGEMENT

Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society ADVANCES IN CARDIA...
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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

ADVANCES IN CARDIAC SYMPTOM MANAGEMENT

George Rizk, MD Yavapai Regional Medical Center Cardiology Care Learning Objectives:

 Discuss limitations of cardiology surgical procedures in high risk & palliative patients.  Review Transcatheter Valvular replacement options and procedures.

DISCLOSURE OF COMMERCIAL SUPPORT George Rizk, MD does not have a significant financial interest or other relationship with manufacturer(s) of commercial product(s) and /or provider(s) of commercial services discussed in this presentation.

The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

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ADVANCES IN CARDIAC SYMPTOM MANAGEMENT

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Update in Nonsurgical Procedures in Cardiovascular Disease.

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Any Application to Palliative care?

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Overview

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Present cardiac therapy in palliative care

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Traditional surgical approach

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Present percutaneous approaches

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Trans catheter Aortic Valve replacement (TAVR)

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Mitra-Clip

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The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

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Medical Therapy in Palliative care

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Mainly studied and used with congestive heart failure

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Beta Blockers, diuretics, Ace inhibitors.

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Inotropic therapy (ie Dobutamine): Is there a role?

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Percutaneous coronary interventions

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Angioplasty and stenting

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The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

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Conventional approaches

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Open Thoracotomy Procedures

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CABG and Valve replacement

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Conventional Approaches

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Extensive data with relatively low to moderate risk patients

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Low peri-operative morbidity and mortality

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Not option for palliative care

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However became the basis to develop percutaneous techniques for advanced risk cases

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The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

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Percutaneous Valve Therapies

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Aortic and Mitral Balloon Valvuloplasty

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Aortic procedure only palliative and usually duration before restenosis 6 months.

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Mitral valve balloon valvuloplasty mainly for treatment of mitral stenosis.

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The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

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Transcutaneous Aortic valve Replacement

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Saipien (Balloon) expandable

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PARTNER-A (AVR vs TAVR: non-inferior); and B (TAVR vs medical therapy: superior) trials

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Core Valve (Self expanding)

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CORE Valve trial

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History

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Non surgical candidates

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Increased operative risk secondary to comorbidities.

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STS score

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CoreValve US Screening Committee

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Futility

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Inability to survive one year despite AVR

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Extreme Risk Estimated 1 Month mortality risk or irreversible morbidity > 50%

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High Risk

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Estimated surgical risk > 15% 1 Month mortality but 40 mm Hg or peak velocity > 4 m/sec at rest or with dobutamine stress (if LVEF < 50%) • NYHA functional class II or greater



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Exclusion Criteria (selected): •

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Recent active GI bleed (3 mos), stroke (6 mos), or MI (30 days) • Creatinine clearance < 20 mL/min • Significant untreated coronary artery disease • LVEF < 20% • Life expectancy < 1 year due to co-morbidities

TCT 2013

Extreme Risk Study | Iliofemoral Pivotal

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Participating Sites

___________________________________ U of Michigan

Providence

Ann Arbor, MI

Spectrum

Spokane, WA

Detroit Medical U of Pitt Center Pittsburg, PA

Grand Rapids, MI

Aurora St. Lukes

Morristown, NJ

Boston, MA

Yale New Haven, CT

St. Francis

VA Palo Alto, CA

North Shore Manhasset, NY

Loyola

Iowa Heart

El Camino U of Kansas

Mount Sinai Lenox Hill

Maywood, IL

Des Moines, IA

Mountain View, CA

Saint Vincent

Riverside Methodist

Indianapolis, IN

Columbus, OH

Kansas City, KS

USC Los Angeles, CA

Kaiser Permanente Banner

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Columbus, OH

Geisinger Danville, PA

Duke

Vanderbilt Nashville, TN

Winston Salem, NC

Atlanta, GA

Baylor

Ohio State

Wake Forest

Piedmont

Phoenix, AZ

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Roslyn, NY

UH Case Cleveland, OH

VA Palo Alto

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Beth Israel

Detroit, MI

Milwaukee, WI

Los Angeles, CA

Morristown

Saint Joseph’s Atlanta, GA

Dallas, TX

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Pinnacle

Durham, NC

Wormleysburg, PA

Johns Hopkins Baltimore, MD

Washington Hospital Center Washington, DC

Inova Fairfax Methodist

St. Luke’s

Houston, TX

Houston, TX

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Falls Church, VA

Mount Sinai

U of Miami

Miami, FL

Miami, FL

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487 Patients Enrolled at 40 Participating Sites TCT 2013

Extreme Risk Study | Iliofemoral Pivotal

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Baseline Demographics

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Extreme Risk Study | Iliofemoral Pivotal

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The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

Baseline Co-Morbidities

___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ *STS Criteria: Severe = FEV1 < 50% predicted and/or RA pO2 < 60 or pCO2 > 50

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**Charlson Score: = 1 MI, CHF, PVD, CVD, dementia, chronic lung disease, connective tissue disease, ulcer, mild liver disease, DM; = 2 hemiplegia, mod-severe kidney disease, diabetes with end organ damage, leukemia, lymphoma; = 3 moderate or severe liver disease; = 6 metastatic solid tumor, AIDS TCT 2013

Extreme Risk Study | Iliofemoral Pivotal

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Frailty Assessment

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Extreme Risk Study | Iliofemoral Pivotal

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CoreValve Extreme Risk Iliofemoral Results

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TCT 2013

Extreme Risk Study | Iliofemoral Pivotal

The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

Primary Endpoint

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Extreme Risk Study | Iliofemoral Pivotal

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1 Year Mortality

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Extreme Risk Study | Iliofemoral Pivotal

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NYHA Class Survivors

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Extreme Risk Study | Iliofemoral Pivotal

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The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

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Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

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MitraClip

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Percutaneous Mitral Valve Repair

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The MitraClip Story

___________________________________ © 2012 Abbott. All rights reserved. PML03912 . Rev. C (06/2012)

Severity of MR in Heart Failure Patients is Independently Predictive of Survival Probability

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Survival of Heart Failure Patients with MR by Degree of MR

Survival Probability

Adjusted for demographics and clinical variables at baseline

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No MR Mild MR (1+ or 2+) Mod/sev MR (3+ or 4+)

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Years: N = 2057N = 1587N = 1252 N = 977 N = 772 N = 623 Note: Adjusted survival estimates are shown. Source: Trichon BH et al. Am J Card. 2003,91:538-43.

© 2012 Abbott. All rights reserved. PML03912 Rev. C (06/2012)

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The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

11

Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

Many patients are not considered appropriate candidates for mitral valve surgery

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Large portion of mitral regurgitation patients are left untreated— ineligible for surgical treatment or denied surgical intervention12

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2% Factors prohibiting Surgery include6:

Surgical Patients (30K)

Impaired LVEF High operative risk Multiple comorbidities

49%

49%

High-Risk Patients*,3-5 (860K)

Surgical Candidates (850K)

Of surgical candidates, up to 50% of patients are not referred to surgery, even if a surgical indication exists 2

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Advanced age

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Data on file Abbott Vascular.

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1.Lung B, et al. Eur Heart J. 2003;24:1231-1243. 2.Mirabel M, et al. Eur Heart J. 2007;28:1358-1365. 3.U.S. Census Bureau, Statistical Abstract of the U.S. 4.Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: 1005-11. 5.Patel, et al. Mitral Regurgitation in Patients with Advanced Systolic Heart Failure, J of Cardiac Failure, 2004. 6.Rankin, et al, J of Thoracic and Cardiovascular Surgery, March 2006.

© 2012 Abbott. All rights reserved. PML03912 Rev. C (06/2012)

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MitraClip System First-in-class, Leading Technology

__________________________________ The MitraClip System is a first-in-class technology supported by robust clinical evidence

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Establishes vertical coaptation while capturing the leaflets and drawing them together

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Repositionable to allow real-time MR assessment prior to deployment

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Supported by data from the EVEREST clinical trial program* and numerous realworld studies

___________________________________ ___________________________________ ___________________________________ * Data on file Abbott Vascular. © 2012 Abbott. All rights reserved. PML03912 Rev. C (06/2012)

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EVEREST High Surgical Risk Cohort

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EVEREST High Surgical Risk Cohort N=372*

EVEREST II High Surgical Risk Study^ N=78

1 Year N=78

REALISM High Surgical Risk Study^ N=294

1 Year N=133

Demographics and morbidities Age (years)

High Risk Cohort (N=211)

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76 ± 10

≥ 75 years, (%)

57

Predicted Mortality †, (%)

15

Prior Cardiac Surgery, (%)

58

History Myocardial Infarction, (%)

49

Prior Stroke, (%)

14

COPD/Chronic Lung Disease, (%)

30

Moderate to Severe Renal Failure, (%)

31

History Atrial Fibrillation, (%)

64

Diabetes Mellitus, (%)

40

Ejection Fraction < 30%, (%)

EVEREST High Surgical Risk Cohort With 1 Year Follow-up^ N=211

Co-

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LV ESD, (mm)

4.2

NYHA Class III or IV, (%)

86

Etiology—Functional MR, (%)

71

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†Based on STS ≥ 12% or an assigned mortality 12% for pre-specified co-morbidities

*As of April 12, 2011 ^Enrolled by February 28, 2010

© 2012 Abbott. All rights reserved. PML03912 Rev. C (06/2012)

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The information in this document may not be reproduced or disclosed to unauthorized parties without the prior consent of the Arizona Geriatrics Society. 2014 Arizona Geriatrics Society All Rights Reserved

12

Summer Geriatrics Interprofessional Conference - - Palliative Care: State of the Art & Art of the State Arizona Geriatrics Society

EVEREST II RCT Results

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Mitral Regurgitation Grade

Safety Endpoint: 30 Day MAE

Baseline, 1 & 2 Yrs (Matched) – Intention to Treat

Intention to Treat

* * * * † ‡ † ‡ 2+ 0+ 1+ 2+ 0+ 0+of Mitral Clinically 1+Significant Reduction 3+ 3+Regurgitation 1+ 1+ 2+ 2+ 2+ 2+ 3+ 3+ 4+ 4+ 4+ 3+ 4+ (N=122) (N=122) (N=122) (N=56) (N=56) (N=56) Percutaneous Surgery

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# (%) Patients Experiencing Event 30 Day MAE Death Major Stroke Re-operation of Mitral Valve Urgent / Emergent CV Surgery Myocardial Infarction Renal Failure Deep W ound Infection Ventilation >48 hrs New Onset Permanent Atrial Fib Septicemia GI Complication Requiring Surgery Transfusions ≥2 units TOTAL % of Patients with MAE

Percutaneous (N=180) 2 (1.1%) 2 (1.1%) 0 4 (2.2%) 0 1 (0.6%) 0 0 2 (1.1%) 0 2 (1.1%) 24 (13.3%) 15.0%

Surgery (N=94) 2 (2.1%) 2 (2.1%) 1 (1.1%) 4 (4.3%) 0 0 0 4 (4.3%) 0 0 0 42 (44.7%) 47.9%

Superior Safety With Low Major Adverse Event Rates Compared To Surgery

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erestgroup II RCT – ACC 2011 gational Device only in US. Not available for saleIIgroup in thedifference ween difference atthe 1 year (p