15th annual biomarkers in heart failure and acute coronary...

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

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







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?







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







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)

15th annual biomarkers in heart failure and acute coronary...

Documents