1/29/2020 1 Role of CardioMEMS in Management of Heart Failure Anand Deshmukh, MD FACP FACC FSCAI FSVM Methodist Jennie Edmundson Hospital Nebraska Methodist Hospital Methodist Physicians Clinic Disclosures • None Objectives Heart Failure • Scope of the problem • Impact of various strategies to reduce heart failure hospitalization • Role of CardioMEMS in management of heat failure – a. Technical details • b. Evidence to assess efficacy and safety • c. Indications for CardioMEMS placement • d. Cost efficacy
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• Impact of various strategies to reduce heart failure hospitalization
• Role of CardioMEMS in management of heat failure – a. Technical details
• b. Evidence to assess efficacy and safety
• c. Indications for CardioMEMS placement
• d. Cost efficacy
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Heart failure Scope of the problem
Heart Failure is a Growing Global Clinical Burden• UNITED STATES
5
1. AHA 2016 Statistics at a Glance, 2016.
2. Krumholz HM, et al. Circ Cardiovas Qual Outcomes, 2009.
3. Heidenreich PA, et al. Circ Heart Failure, 2013.
HIGH INCIDENCE, HIGH PREVALENCE, AND POOR PROGNOSISdespite advances in the treatment of heart failure over the past few decades.
PREVALENCE 2.2%Prevalence1
5.7mHF patients1
Projected to increase to > 8M people ≥ 18 years of age with HF by 20301
INCIDENCE915,000
people ≥ 45 years of age are newly diagnosed each year with HF.1
MORBIDITY AND MORTALITY
For AHA/ACC stage C/D patients diagnosed with HF:
50% Readmitted within
6 months.2
50% Will die within
5 years.3
*Study projections assumes HF prevalence remains constant and continuation of current hospitalization practices
Heart Failure is a Growing Economic Burden
HOSPITALIZATIONS AND READMISSIONS COSTS
> 1,100,000hospitalizations
for HF1
> 3,000,000hospitalizations
include HF as a contributor.2
Total medical costs for HF are projected to
increase to $70B
by 2030, a 2x increase from 2013.*
50% of the costs are
attributed to hospitalization.6~5 days
average length of hospital stay3
~25%all-cause readmission within 30 days; ~50% within 6 months.4,5
Despite advances in medical therapies to treat heart failure, the hospitalization rate has not changed significantly from 2000. As a result, heart failure continues to be a
MAJOR DRIVER OF OVERALL HEALTH CARE COSTS.
UNITED STATES
1. CDC NCHS National Hospital Discharge Survey, 2000-10.
2. Blekcer et al. J Am Coll Cardiol, 2013.
3. Yancy et al. J Am Coll Cardiol, 2006.
4. Wxler DJ, et al. Am Heart J, 2001.
5. Krumholz HM, et al. Circ Cardiovas Qual Outcomes, 2009.
6. Yancy CW, et al. Circulation, 2013.
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• EACH EVENT ACCELERATES DOWNWARD SPIRAL OF MYOCARDIAL FUNCTION
With each subsequent HF-
THE GOAL:Maintain fluid volume to avoid
acute decompensation and hospitalization
HF HOSPITALIZATION is a valid endpoint for measuring
decompensation
Goal of Heart Failure Management: SLOW DISEASE PROGRESSION BY PREVENTING DECOMPENSATION
7Gheorghiade MD, et al. Am J. Cardiol, 2005.
Acute Event
TIME
MYO
CA
RD
IAL
FUN
CTI
ON
Kaplan-Meier cumulative mortality curve all-cause mortality after each subsequent hospitalization for HF.
Long-term Mortality Risk Increases with Multiple Hospitalizations
Change from baseline in PA mean pressure (mean AUC [mmHg x days])
-156 33 0.008
Number and proportion of patients hospitalized for HF (%)
55 (20%) 80 (29%) 0.03
Days alive and out of hospital for HF (mean ± SD)
174.4 ± 31.1
172.1 ± 37.8
0.02
Quality of life (Minnesota Living with Heart Failure Questionnaire, mean ± SD)
45 ± 26 51 ± 25 0.02
31
• *Total of 8 DSRCs including 2 events in Consented not implanted patients (n = 25)
• Abraham WT, et al. Lancet, 2011.
PART 1: RANDOMIZED ACCESS
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Both Primary Safety Endpoints Met
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• 1167 patient-years of follow-up• 8 device/system-related complications (DSRC) • 0.007 DSRC per patient-year• All DSRC occurred within 30 days of implant• No sensor failures
Prospective Subgroup Analysis: HFpEF PATIENTS MANAGED WITH THE CardioMEMS™ HF SYSTEM
SHOW SIGNIFICANT REDUCTION IN HF Hospitalization
33
Avg. 18 months follow-up50% RRR, p < 0.0001
50 % reduction in HF Hospitalization
• Adamson PB, Abraham WT, Bourge RC, et al. Circ Heart Fail, 2014 Nov;7(6):935-44.
The CHAMPION Trial Subgroup Analyses: REDUCTION OF HF HOSPITALIZATION IN PATIENT GROUPS
WITH COMMON COMORBIDITIES
34
1. Adamson, et al. Circ Heart Fail, 2016.
2. Adamson, et al. Circ Heart Fail, 2014.
3. Abraham, et al. ACC, 2015.
4. Abraham, et al. HRS 2015.
5. Strickland WL, et al. J Am Coll Cardiol, 2011.
6. Criner G, et al. Eur Respir J, 2012.
7. Martinez F, et al. Eur Respir J, 2012.
8. Benza R, et al. J Card Fail, 2012.
9. Miller AB, et al. J Am Coll Cardiol, 2012.
10. Abraham, et al. J Card Fail, 2014.
Sub-Group or Comorbidityn
(control)n
(treatment)Follow-up
Period (months)
Reduction of HF Hospitalization Rate in
Treatment Group vs. control
Medicare population1 125 120 18 49%, p < 0.0001
HFpEF2 56 59 18 50%, p < 0.0001
HFrEF following GDMT3 174 163 17 43%, p < 0.0001
CRT-D or ICD following GDMT4 146 129 18 43%, p < 0.0001
History of myocardial infarction5 137 134 15 46%, p < 0.001
COPD6,7 96 91 15 41%, p = 0.0009
Pulmonary hypertension8 163 151 15 36%, p = 0.0002
AF9 135 120 15 41%, p < 0.0001
Chronic kidney disease10 150 147 15 42%, p = 0.0001
Patients with common HF comorbidities and patients in important subgroups HAVE CONSISTENT REDUCTION IN HF HOSPITALIZATIONS with PA pressure-guided therapy.
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NNT to Prevent One HF Hospitalization for PA Pressure Monitoring and Medical Intervention Alone
• PART 1: RANDOMIZED ACCESS
35
• 1. Packer M, et al. Circulation, 2002.
• 2. Pitt B, et al. N Engl J Med, 1999.
• 3. Cleland JG, et al. N Engl J Med, 2005.
• 4. Hjalmarson A, et al. JAMA, 2000.
• 5. The SOLVD Investigators. N Engl J Med, 1991.
• 6. Zannad F, et al. N Engl J Med, 2011.
• 7. Digitalis Investigation Group. N Engl J Med, 1997.
CardioMEMS- Impact on Survival Subgroup Analysis:HFrEF PATIENTS WITH CRT-D FOLLOWING GDMT
39Abraham, et al. HRS 2015.
64% reduction (p = 0.028)
CardioMEMS- Indications
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Indications for CardioMEMS™ HF System?
THE CARDIOMEMS™ HF SYSTEM IS INDICATED FOR THESE PATIENTS1:
NYHA Class III heart failure
One heart failure hospitalization in the past 12 months
PATIENTS WHO MOST COMMONLY RECEIVE THE CARDIOMEMS™ HF SYSTEM ARE THOSE ON GDMT AND THOSE WHO EXHIBIT ANY OF THE FOLLOWING1:
□ Fluid volumes are hard to know or manage□ Physical assessment is challenging□ Is a patient with HFpEF or HFrEF□ Compliant with heart failure medical care□ Would benefit from remote monitoring
if they live far from clinic
CardioMEMS- Cost Efficacy
Treatment Costs CHAMPION TRIAL
• Treatment group
• Average quality adjusted life expectancy of 2.506 QALYs
• Total cost of $ 68,919
• Control group
• Average quality adjusted life expectancy of 2.200 QALYs
• Total cost $ 64, 637
Abraham WT, et al. Lancet, 2011.
Incremental cost effectiveness ratio of integrating PA sensor into standard of care for management of heart failure was $ 13, 979 per QALY gained
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Real-world Use of the CardioMEMS™
HF System:ASSOCIATED HF HOSPITALIZATION COSTS
$28,870
$47,690
$18,360
$34,500
$0K
$10K
$20K
$30K
$40K
$50K
$60K
$70K
$80K
6-MONTH COHORT 12-MONTH COHORT
Pre-Implant Post-Implant
-$10,510
-$13,190
Large (N = 1114) retrospective cohort study using the CardioMEMS™ HF System patients from CMS database
Desai, AS, et al. J Am Coll Cardiol, 2017;69(19):2357–65.
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SUMMARY – CARDIOMEMS PA SENSOR
. 45
HEART FAILURE HOSPITALIZATION COSTS3
LOWER
DECREASE
MORTALITY4,5**
*Includes a 48% reduction in heart failure hospitalizations,1 a 58% reduction in all-cause 30-day readmissions,8 and a 78% reduction in heart failure-specific 30-day readmissions.8
**CardioMEMS™ HF System is not indicated for a reduction in mortality. Based on retrospective cohort studies using the CardioMEMS HF System patients from CMS database.
QUALITY OF LIFE AND FUNCTIONAL CAPACITY1,2
REDUCE
IMPROVE
Patients benefit REGARDLESS OF EF OR GENDER6,7
H
HEART FAILURE HOSPITALIZATIONS1,3*
1. Abraham WT, et al. The Lancet, 387(10017), 453-461.
2. Jermyn R, et al. Clinical Cardiology. doi: 10.1002/clc.22643.
3. Desai AS, et al. J Am Coll Cardiol, 2017;69(19):2357–65.
4. Abraham, et al. Presented at ACC 2018
5. Givertz MM, et al. J Am Coll Cardiol 2017; 70:1875–86.
6. Adamson PB, et al. Circulation: Heart Failure, 7(6), 935-944.
7. Heywood JT, et al. Circulation 2017;135: 1509–17.
8. Adamson, et al. Circulation Heart Failure 2016;115.002600.
98.6%FREEDOM FROM DEVICE OR SYSTEM COMPLICATIONS(p < 0.0001)1
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