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
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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
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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
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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