Howie Tran MD, FACCAssistant Professor of Medicine, University of California, San DiegoAdvanced Heart Failure, Cardiac Transplantation & Mechanical Circulatory Support
Mar 1, 2019
15th Annual Biomarkers in Heart Failure and Acute Coronary SyndromesCardioMEMs Ambulatory PAP monitorIncorporating PA Device and Biomarkers in Outpatient with HF
No relevant disclosures for either medications or devices discussed in this talk. I will not be discussing off label use of devices or
medications.
No specific patients will be discussed during this lecture. No patient consent is necessary.
Disclosure Information and Patient Consent
Overview of the Talk• Discussion of the Burden of Heart
Failure and Readmissions
• Prior Attempts of Remote Monitoring
• Abbott Ambulatory Pulmonary Artery
Pressure Monitoring: CardioMEMS
• Boston Scientific HeartLogic Remote
Monitoring
Overview of the Talk• Discussion of the Burden of Heart
Failure and Readmissions
• Prior Attempts of Remote Monitoring
• Abbott Ambulatory Pulmonary Artery
Pressure Monitoring: CardioMEMS
• Boston Scientific HeartLogic Remote
Monitoring
1. Adams KF, et al. Am Heart J. 2005.
2. Krum H and Abraham WT. Lancet 2009.
3. Lala A, et al. JCF 2013.
41% of previously decongested
patients had severe or partial re-congestion3
Post-hoc analysis of 463 acute
decompensated HF patients from DOSE-HF
and CARRESS-HF
90%of HF hospitalizations due to symptoms of pulmonary
congestion1,2
AT DISCHARGE
40% moderate to severe
congestion3
60% absent or mild congestion3
AT 60-DAY FOLLOW-UP
TODAY’S TOOLS ARE INADEQUATEat relieving congestion
(inpatient) and preventing re-congestion and
readmission (outpatient) –even at well-established
HF management programs and with the best HF-
trained specialists.
Current HF ManagementHow well do current tools keep patients stable and out of the hospital?
The Iceberg Analogy
Photo by National Geographic
Overview of the Talk• Discussion of the Burden of Heart
Failure and Readmissions
• Prior Attempts of Remote Monitoring
• Abbott Ambulatory Pulmonary Artery
Pressure Monitoring: CardioMEMS
• Boston Scientific HeartLogic Remote
Monitoring
Trial NParameter Monitored/
Clinician InteractionImpact on
HF HospitalizationReference
TELE-HF1 1,653 Signs/symptoms, daily weights None Chaudhry SI et al. N Engl J Med, 2010
TIM-HF2 710 Signs/symptoms, daily weights None Koehler F et al. Circulation, 2011
TEN-HMS3 426Signs/symptoms, daily weights, BP, nurse telephone support
None Cleland JG et al. JACC, 2005
BEAT-HF4 1,437Signs/symptoms, daily weights, nurse communications
None Ong MK et al. AHA 2015 LBCT
INH5 715Signs/symptoms, telemonitoring, nurse coordinated DM
NoneAngermann DE et al. Circ Heart Fail, 2012
DOT-HF6 335 Intrathoracic impedance with patient alert IncreasedVan Veldhuisen DJ et al. Circulation, 2011
Optilink7 1,002 Intrathoracic impedance None Bohm M et al. Eur J HF, 2011
REM-HF8 1,650 Remote monitoring via ICD, CRT-D, or CRT-P None CowieMR et al. ESC 2016
MORE CARE9 865
Remote monitoring of advanced diagnostics via CRT-D
None Boriani G et al. Eur J HF, 2016
Total 8,793
Multiple trials studying >8500 patients have demonstrated that current markers have NO IMPROVEMENT ON HF
HOSPITALIZATION
Current HF ManagementHow do current parameters impact HF hospitalization?
Overview of the Talk• Discussion of the Burden of Heart
Failure and Readmissions
• Prior Attempts of Remote Monitoring
• Abbott Ambulatory Pulmonary Artery
Pressure Monitoring: CardioMEMS
• Boston Scientific HeartLogic Remote
Monitoring
Current HF Management: Why aren’t current parameters working?
Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.
Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.
Current HF Management: How can we get ahead of symptoms associated with acute decompensation?
Intracardiac Pressures:
Sensor = hermetically sealed capsule
containing a inductor coil and pressure-
sensitive capacitor
Anchor = Nitinol wire
loops extend to
stabilize the sensor in
the implant location
Change in blood pressure
affects resonant frequency
Tracked by external measurement
system pulmonary artery pressure
CardioMEMSTM: PA Sensor Technology
Prospective, multicenterRandomized single-blinded trial
64 sites in the US550 patients
NYHA functional Class III HF(h/o HF > 3 mos)
October 2009 until March 2010
Standard-of-care HF management
CardioMEMs
Follow up: month 1, 3, 6, then every 6 months thereafter, up to 36 months
Transmitted informationPressure trend information
PAsys pressure 15-35 mmHgPAdia pressure 8-20 mmHgPAmean pressure 10-25 mmHg
Target hemodynamic monitoring pressure values
Cumulative Heart Failure-related
Hospitalization
Abraham et al. Lancet 2011; 377:658-66
Intervention TrialMean Duration of Randomized
Follow-Up
NNT/Year toPrevent 1 HF
Hospitalization
Beta-blocker1 COPERNICUS 10 months 7
Aldosterone antagonist2 RALES 24 months 7
CRT3 CARE-HF 29 months 7
Beta-blocker4 MERIT-HF 12 months 15
ACE inhibitor5 SOLVD 41 months 15
Aldosterone antagonist6 EMPHASIS-HF 21 months 16
Digoxin7 DIG 37 months 17
Angiotensin receptor blocker8 Val-HeFT 23 months 18
Angiotensinreceptor blocker9 CHARM 40 months 19
PA pressure monitoring10 CHAMPION 18 months < 4
PART 1: RANDOMIZED ACESS PART 2: OPEN ACCESS
PA PRESSURE MONITORING
LED TO LOWER NNT to prevent one HF-related hospitalization
vs. other therapies.
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.
8. Cohn JN, et al. N Engl J Med. 2001.
9. Young JB, et al. Circulation. 2004 .
10. Adamson, P. et al. HFSA 2016.
CHAMPION Trial Results: Number Needed to Treat to Prevent One HF-related hospitalizations
Ponikowski et al. Eur Heart J. 2016; 37: 2129-2200
2016 ESC GuidelinesTreatment of Chronic heart failure
Current HFpEF ManagementWhat are the current recommendations?
Adamson et al. Circ Heart Fail. 2014; 7:935-944
Wireless PAP MonitoringManagement to Reduce Decompensation in HFpEF
Data from Merlin.net (St Jude Medical) database
Heywood et al. Circulation. 2017; 135(16):1509-1517
Methods
• Registry for first 2000 CardioMEMS HF
System patients
• 6 months or more follow-up
Heywood et al. Circulation. 2017; 135(16):1509-1517
CardioMEMsWorkflow
UCSD Heart Failure
Selection of potential patients
Inclusion Criteria: (all must be met) 1 or more hospitalization for acutely decompensated heart failure < 12 months Persistent NYHA Class III symptoms for at least 3 months or elevated BNP > 300 Presently on optimal evidence based medical and device therapy for heart
failure Active enrollment with CHF program and run-in period of compliance
Relative Contraindications History of poor medical or clinical compliance BMI > 35 kg/m2 or thoracic circumference > 65cm
Absolute Contraindications History of MI or CVA within the past 2 months History of recurrent DVT or pulmonary emboli History of CKD (Stage IV or V), GFR < 25 mL/min/m2 Implantation of CRT within past 3 months Mechanical Right-sided Heart Valve Replacement History of Coagulation disorder or unable to tolerate anti-platelet therapy
Monitoring: 2 weeks Post Implant
First 2 weeks: daily monitor• Quality of waveforms (believable or waveform needs “manual
tweaking” to interpret)• Respiratory/positional and diural variations• Changes before/after medications• AM values
After PAD is at goal, we monitor by exception • Setting thresholds and only looking if thresholds are crossed• If thresholds have not been crossed, we look once a week (for
regulatory compliance reasons)
Goal PAD ∆PAD > + 10mmHg∆PAD > - 5mmHg
Intervention Intervention
In this zone, no intervention needed unless, if trend remains for three days (depending on patient, age, renal function)
The Future of CardioMEMsExpansion of Monitoring
GUIDE-HF NYHA Class II, III, or IV HF patients (NTpBNP/BNP OR HFH)
HEMO-VAD CardioMEMs guided hemodynamics prior to LVAD
Corbally D et al
Overview of the Talk• Discussion of the Burden of Heart
Failure and Readmissions
• Prior Attempts of Remote Monitoring
• Abbott Ambulatory Pulmonary Artery
Pressure Monitoring: CardioMEMS
• Boston Scientific HeartLogic Remote
Monitoring
The Evaluation of a Heart Failure Patient- a typical office encounter -
Listen to the heart for signs of elevated S3 heart sounds
Listen to the heart for signs of depressed cardiac contractility
Listen to lung sounds for signs of pulmonary edema
Measure blood pressure
Measure if resting heart rate is elevated
Ask “How many pillows do you sleep on at night?”
Ask “Are you out of breath? Have difficulty breathing?”
Ask “Have you been feeling tired?”
Ask “Have you gained weight?”
Typical tests and in-office questions that providers may ask the patient
Heart SoundsS1 & S3
ImpedanceThoracic
RespirationRate & Volume
ActivityTime Spent Active
Heart RateNight
multiple sensor
measurements
combined into
a single, simple
index with alert
HeartLogic™ incorporates multiple sensors with a single composite alertAvailable on LATITUDE
™NXT
for patients with
Resonate™
family of
ICDs & CRT-Ds
HeartLogic Heart Failure Diagnostics- a method of proactive care-
-180 -150 -120 -90 -60 -30 -0 30
0
5
10
15
20
25
Days Relative to Event
Hea
rtLo
gic
Ind
ex
HF Event
Nominal Alert Threshold
16
Gardner et al. Circ Heart Fail 2018;11:e004669
HeartLogic index is significantly elevated about 28 days before a Heart Failure Event as compared to its baseline value
Gardner et al. Circ Heart Fail 2018;11:e004669
HeartLogic Multisensor Algorithm: Identification of Increased Risk of HF Events. Results of the MultiSENSE Study
MultiSENSE Study• High sensitivity of 70% for detecting heart failure events• Weeks of advance notice of a potential heart failure event• Low burden of less than 2 alerts per patient per year
Conclusions:1. The clinical and economic burden of HF in
America continues to be on the rise
2. The CardioMEMSTM device and the
HeartLogic algorithmTM may be a resource
to guide therapy (to reduced readmissions
for congestion)
3. Patient selection is crucial for remote
hemodynamic monitoring
4. Workflow is essential in closing the loop
with continuous data.
The Iceberg Analogy
Photo by National Geographic
Just don’t leave your patients hanging
Photo by Carla Lombardo Ehrlich (World Wildlife Foundation)