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Transcript
3/30/2015
Update in Advanced
Therapies for Heart Failure
Brent C. Lampert, DO
15th Annual Cardiovascular Symposium
April 9, 2015
1
Disclosures
ƒ No conflicts of interest
ƒ No financial relationships
2
1
3/30/2015
Objectives
ƒ Review factors that help identify high risk heart
failure patients
ƒ Review the CardioMEMS implantable PA
hemodynamic monitoring system
ƒ Review the patient selection process and current
outcomes for cardiac transplantation
3
Heart Failure
ƒ Affects ~ 6 million
people in the U.S.
ƒ Expected to increase >
25% by 2030
ƒ 60,000 deaths per year
directly attributed to HF
ƒ Half of patients die w/in
5 yrs of diagnosis
ƒ Costs $34.4 billion
annually in the U.S.
Hospital Discharges for HF by sex
Go, et al. Circulation 2013.
Heidenriech, et al. Circulation 2011
4
2
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Heart Failure Treatment
5
Identifying Patients for Advanced Therapies
A balance:
Risks of multi-system
organ failure from
progressive heart failure
(> 50% death in 1 year)
versus
Risks of surgical
intervention and
chronic management of
MCS/Tx
3
3/30/2015
Identifying Patients for Advanced Therapies
Indications for Cardiac Transplant
ƒ High-risk HF patients / Stage D disease
ƒ Isolated cardiac disease for which no other therapies
exist
ƒ Refractory VT
ƒ Refractory angina
ƒ Certain restrictive cardiomyopathies
7
Identifying High Risk HF Patients
ƒ Criteria for referral of pts < 80 y.o. to HF Specialist:
ƒ SBP < 90
ƒ Creatinine ≥ 1.6
ƒ Hemoglobin ≤ 12
ƒ No RAS antagonist
ƒ No β-blocker
ƒ Presence of 1,2, or 3-5 factors = 79%, 60%, or 39%
1-year survival
Thorvaldsen, et al. JACC 2014.
8
4
3/30/2015
Treatment Options
ƒ CardioMEMS
ƒ Intravenous Inotropes
ƒ Ultrafiltration
ƒ Cardiac Transplantation
ƒ Mechanical Circulatory Support
ƒ Palliative Care
9
CardioMEMS
ƒ Implantable hemodynamic
monitoring
ƒ CHAMPION Trial
ƒ 390 NYHA III pts (23%
HFpEF)
ƒ 37% ↓ in HF
hospitalizations over
average of 15 mos
ƒ HFpEF 0.16 vs 0.33
(p<0.0001)
ƒ HFrEF 0.36 vs 0.47
(p=0.007)
ƒ Low (1.4%) rate of device
related complications
10
5
3/30/2015
CardioMEMS
11
CardioMEMS – Patient List
12
6
3/30/2015
CardioMEMS – Physician Website
Trend Data
• Physician
notification
• Home
transmission
• Secure, encrypted
web-based access
13
Cardiac Transplantation
1967: Christian
Barnard performs first
heart transplant in 54
y.o. man Æ pt dies 18
days later d/t
pneumonia
1968: Shumway
performs first heart
transplant in U.S.
1968:102 transplants
at 52 centers Æ 28%
alive at 12 weeks
1981: Cyclosporine
immunosuppression
introduced
14
7
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Post Transplant Survival
Lund, JHLT 2014
15
The Problem
Supply
8
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The Problem
Lund, JHLT 2014
17
Transplant Patient Selection
ƒ Donor organs are a limited resource
ƒ With critical organ shortage, risk stratification &
patient selection is vital
ƒ Challenges:
ƒ Optimal timing
ƒ Determine patients with best chance for long term
survival and improvement in quality of life
18
9
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Transplant Patient Selection
Mancini, et al. Circulation 1991.
19
Transplant Patient Selection
ISHLT Recommendations for
Heart Transplant Evaluation
20
10
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Contraindications
ƒ Conditions with high peri-operative risk
ƒ Conditions that would limit graft function
ƒ Conditions that increase risk of rejection
ƒ Conditions that increase risk of complications
ƒ Other life-limiting conditions
21
Conditions with high perioperative risk
ƒ Bleeding disorders/clotting disorders
ƒ Anatomic considerations
ƒ Multiple repeat surgeries
ƒ Allergies/sensitivities to perioperative medications
ƒ e.g. HIT
ƒ Significant renal disease
ƒ Cerebral vascular disease
22
11
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Conditions that would limit graft function
ƒ Pulmonary hypertension
ƒ RV dysfunction is a major cause of acute graft failure
ƒ Systemic diseases that can affect new heart
ƒ e.g. amyloidosis
ƒ Conditions increasing risk of allograft vasculopathy
ƒ Ongoing smoking/tobacco use
ƒ Exposure to second hand smoke
23
Conditions that increase risk of rejection
ƒ Sensitization
ƒ High PRA levels
ƒ Strategies involving cross-matching can mitigate risk
ƒ Intolerance to immunosuppression
ƒ
ƒ
ƒ
ƒ
Significant renal disease
Uncontrolled diabetes
Myelodysplastic disorders/low cell counts
Ability to comply with complex medical regimen
ƒ Pyschosocial disorders
ƒ Illicit drug use
ƒ Insurance/cost factors
24
12
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Conditions with increased complications
ƒ Obesity (BMI >35)
ƒ Chronic debilitation
ƒ Amputations/non-ambulatory conditions
ƒ Uncontrolled diabetes
ƒ Significant pulmonary disease
ƒ High infectious risk profiles (e.g. HIV)
ƒ Noncompliance or lack of social support
ƒ Substance abuse
25
Other life-limiting/quality-limiting conditions
ƒ Active or recent (<5 yrs) malignancy
ƒ Solid organ or malignant hematological disease
ƒ Required age & risk-appropriate cancer screening
ƒ Age >70 years
ƒ Not absolute contraindication
ƒ Dementia/significant neurological deficits
ƒ Significant renal disease (dialysis risk)
ƒ Dual-organ transplant can be considered
ƒ Peripheral artery disease
ƒ Uncontrolled diabetes
Risk of
progression
on posttransplant
meds
26
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Heart Transplant - Age
27
Heart Transplant – Patient Selection
ƒ Following objective evaluation, each case is
discussed in multi-disciplinary meeting:
ƒ HF Cardiology
ƒ Cardiac Surgery
ƒ Transplant coordinators
ƒ Social Work
ƒ Pulmonology
ƒ Infectious Disease
ƒ Good candidates with a chance to have their lives
improved by transplant are placed on the waiting list
28
14
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Heart Transplant
% of adult wait-listed
patients (2010)
receiving a heart
transplant within 1
year
29
Heart Transplant - Donor Rates
Deceased donor
heart donation
rates (per 1,000
deaths), by state
30
15
3/30/2015
Our Team
ƒ Robert Higgins
ƒ Garrie Haas
ƒ Ayesha Hasan
ƒ Veronica Franco
ƒ Sandi Parsons
ƒ Ramesh Emani
ƒ Susan Montgomery
ƒ Ragavendra Baliga
ƒ Erin Bumgardner
ƒ Sakima Smith
ƒ Emily Jarvis
ƒ Ray Hershberger
ƒ Jodi Knisley
ƒ Kristin Kuntz
ƒ Laura Newman
ƒ Amy Pope-Harman
ƒ Peter Lee
ƒ Stan Martin
ƒ Ahmet Kilic
ƒ Nicole Theodoropoulos
ƒ Bryan Whitson
ƒ Pam Burcham
ƒ Juan Crestanello
ƒ Erik Abel
31
Thank You
32
16