10/10/2015

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Reducing Heart Failure Readmissions with Remote Pulmonary Arterial Pressure

Monitoring

Making Sense of the Sensor

Van Selby, MD

Amanda Schnell-Heringer, RN, MS, CNS

October 9, 2015

Disclosures

• Van Selby: None

• Amanda Schnell-Heringer: None

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Heart failure hospitalizations

Go AS et al. Circulation. 2014; 129: e28-e292.

Physiologic progression

Adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.

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Remote monitoring: Previous trials

• TELE-HF: Telemonitoring with daily weight change and symptoms

• No effect on all-cause mortality or readmission

• COMPASS-HF: Remote intracardiac monitoring

• No significant change in HF-related events

• DOT-HF: Thoracic impedance monitoring

• No effect on morbidity or mortality

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CardioMEMS

Nitinol

loops

Pressure

sensitive

capacitor

• No batteries or leads

• 10 mm nitinol loops keep the

device in place

• The sensor contains a

capacitor capable of

measuring pressure with

extremely high fidelity

• Pressure readings

transmitted wirelessly using

a pillow that is provided to

the patient

CardioMEMS: Sensor Implant

• Right heart catheterization

• Selective pulmonary angiography (~

10 cc contrast)

• Placement in the lower right or left

PA branch, pre-bifurcation

• Vessel lumen: 7-15mm

• Where a Swan balloon would fit in

the wedge position

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CHAMPION-HF

• 550 patients with NYHA class III heart failure randomized to remote

hemodynamic monitoring vs usual care

• HF present for at least 3 months

• At least one hospitalization

• No EF-related enrollment criteria

• Primary endpoint: Rate of HF hospitalization

Abraham WT, et al. Lancet, 2011

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CHAMPION-HF: Treatment algorithm

• All patients took daily home pressure readings

• Pressures were reviewed at least once per week, and more frequently if

indicated for clinical reasons

• Target pressures:

• PA systolic pressure 15-35 mmHg

• PA diastolic pressure 8-20 mmHg

• PA mean pressure 10-25 mmHg

CHAMPION-HF Results

Risk reduction: 36%

Risk reduction: 29%

Abraham WT, et al. Lancet, 2011

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Hemodynamic monitoring leads to more medication changes

Abraham WT, et al. Lancet, 2011

CHAMPION: Safety endpoints

• 15 adverse events reported among 575 device implants

• 7 procedure-related

• 4 bleeding (groin, epistaxis, hemoptysis)

• 3 hospitalizations related to anticoagulation

• No pulmonary infarcts or embolism

• No events required removal of the sensor

• No significant differences in adverse events between the two groups.

• No pressure sensor failures in either group

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CHAMPION: NNT to prevent one HF-related hospitalization

Intervention Trial Mean Duration of Randomized

Follow-Up

Annualized Reduction

in HF Hospitalization

Rates

NNT per year to Prevent 1 HF

Hospitalization

Beta-blocker COPERNICUS 10 months 33% 7

Aldosterone antagonist

RALES 24 months 36% 7

CRT CARE-HF 29 months 52% 7

Beta-blocker MERIT-HF 12 months 29% 15

ACE inhibitor SOLVD 41 months 30% 15

Aldosterone antagonist

EMPHASIS-HF

21 months 38% 16

Digoxin DIG 37 months 24% 17

Angiotensin receptor blocker

Val-HeFT 23 months 23% 18

Angiotensin receptor blocker

CHARM 40 months 27% 19

PA pressure monitoring

CHAMPION 17 months 33% 4

CardioMEMSTM System

• FDA approved May 28, 2014

• No batteries or leads

• Indication

• For wirelessly measuring and monitoring PA pressure and HR

• In patients with NYHA class III HF who have been hospitalized for HF within

the previous year

• Hemodynamic data are used by physicians with the goal of better HF

management and to reduce HF hospitalization

• Certification: requires 3 proctored implants

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UCSF criteria/considerations for CardioMEMS

• At least one HF-related hospitalization in the past year

• No contraindication for DAPT

• Necessary adherence, as demonstrated by:

• Regular lab monitoring

• Able to take meds as instructed

• Attend MD appts regularly

• Able to lie flat

• No major psychosocial barriers to appropriate transmissions and follow-up

• Major exclusions:

• PE/DVT

• GFR<25, unresponsive to diuretics, HD

• Major cardiovascular event within 2 months

• Coagulopathy

• Hypersensitivity to ASA/Plavix

Patient Cases

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Case 1: Ms C

• 70 year old woman with HFrEF: EF 40%

• ACC/AHA stage C, NYHA functional class III

• Past Medical History: Gout, dyslipidemia, OSA, peripheral neuropathy,

obesity, and emphysema

• One HF hospitalization in the previous year

• Six office and ED visits for HF

• Did not tolerate uptitration of oral therapies due to side effects

Post-implant medication changes

Implant, started nitrate therapy Dose increase to 80 mg QHS Dose increase to 120 mg QHS

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Adherence Affects PAD

Did not refill meds Restarted meds PAD increased

Case 1, continued

• Current medications:

• Losartan 150 mg daily

• Bumetanide 4 mg BID, chlorothiazide 250 mg BID

• Carvedilol 50 mg BID

• Isosorbide mononitrate 180 mg BID

• Due to body habitus, difficulty with pressure transmissions

ED visits for HF

Hospitalizations for HF

Telephone calls

Pre-implant 2 1 14

Post-implant 0 0 65

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Case 2: Mr F

• 60 y.o. male with NIDCM due to prior alcohol and cocaine use. Pt reports

no recent use of cocaine and minimal weekly ETOH use.

• HFrEF: EF 20%

• ACC/AHA Stage C, NYHA Class III

• CRT-D, cirrhosis, paroxysmal atrial fibrillation, sleep apnea, COPD.

• Worsening HF symptoms despite maximal treatment.

• Two HF admissions in the previous year

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Increase in PAD and HR

Case 3: Ms K

• 66 year old woman with HFpEF due to restrictive cardiomyopathy

associated with prior radiation

• NYHA class III

• DM, CKD stage III, obesity

• One HF hospitalization in the previous year

• Difficult physical exam

• Ongoing difficulty with fluid retention, fluctuating renal function

• CardioMEMS implanted 1/21/2015

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August 2015: worsening creatinine

0

1

2

3

4

5

6

Creatinine (mg/dL)

8/3: Septra

for UTI

Resource utilization

Hospitalizations/ED visits

Office visits Telephone calls

Pre-implant 3 7 28

Post-implant 0 4 105

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Hemodynamic monitoring in HFpEF

Case 4: Ms W

• 72 yo woman s/p bilateral lung transplant

• Referred to UCSF HF clinic for treatment of HFpEF

• NYHA class III symptoms

• Severe diastolic dysfunction

• Hypertension

• A-fib

• One hospitalization for HF in the year prior

• Ongoing volume overload, dyspnea, hypoxemia, pulmonary edema, and

worsening renal function

• Implanted with CardioMEMS 2/11/2015

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May 2015

• Throughout the month of May, the patient called the office multiple times

per week

• Weight gain

• Worsening lower extremity edema

• Increasing dyspnea and fatigue

Increased

edema, SOB.

Rx Diuril

Hospitalized

for ARF Progressive

edema

Diuril

increased

No

improvement.

Diuril

continued

Edema to

thighs and

abdomen.

Diuril

continued

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Ms W, conclusion

• Creatinine peaked at 4.7

• Hospitalized for acute renal failure

• Discharged, but continued to have problems with edema and dyspnea

Hemodynamic vs clinical management strategies

! Search Results

AB36-02 - Pressure for Action: ImplantablePulmonary Artery Pressure SensorMeasurements Alone Beat Clinical Signs toGuide Prevention of Heart FailureHospitalizations

" May 15, 2015, 1:45 - 2:00 PM #

Authors

Lee R. Goldberg, MD, MPH, Akshay S. Desai, MD, MPH, Maria Rosa Costanzo, MD, Lynne W. Stevenson, MD, Philip B.

Adamson, MD, J. Thomas Heywood, MD and William T. Abraham, MD. University of Pennsylvania, Philadelphia, PA,

Brigham and Women's Hospital, Boston, MA, Midwest Heart Specialists - Advocate Medical Group, Naperville, IL,

Oklahoma Heart Hospital, Oklahoma City, OK, Scripps Clinic, La Jolla, CA, Ohio State University Heart Center,

Columbus, OH

Disclosures

L.R. Goldberg: A - Consulting Fees/Honoraria; 1; St. Jude Medical, Boston Scientific Corp., Respicardia. I -

Research Grants; 2; CardioMEMS. A.S. Desai: A - Consulting Fees/Honoraria; 1; CardioMEMS, St. Jude Medical. M.

Costanzo: I - Research Grants; 1; CardioMEMS, St. Jude Medical. L.W. Stevenson: I - Research Grants; 1;

CardioMEMS, St. Jude Medical. P.B. Adamson: A - Consulting Fees/Honoraria; 1; CardioMEMS, St. Jude Medical. J.

Heywood: A - Consulting Fees/Honoraria; 1; CardioMEMS, St. Jude Medical. W.T. Abraham: A - Consulting

Fees/Honoraria; 1; St. Jude Medical.

Abstract

Introduction: Ambulatory hemodynamic monitoring of pulmonary artery pressures (PAP) decreased heart failure

hospitalizations (HFH) when pressure information was available to treating physicians in the CHAMPION trial.

However, it has not been determined how this PAP information was useful in addition to traditional clinical findings

related to congestion and fluid balance.

Methods: In the CHAMPION trial, 550 patients with NYHA class III HF and a HFH in the previous year were

randomized to Control (280) or PAP management (270). All interventions for patients in the PAP managed group

were characterized prospectively by investigators as triggered primarily by clinical findings OR by changes in PAP. All

interventions in the Control group were based only on clinical findings including changes in weight, symptoms or

physical findings.

Results: During the 6 month primary endpoint period, there were 585 changes in diuretic therapy in the Control

group and similar 594 triggered by clinical changes in the PAP managed group, in which an additional 953 were

triggered by PAP. HFH rates remained high in the PAP managed group if diuretic interventions were made only for

clinical changes. HFH rates were lowest in the patients for whom all diuretic interventions were triggered by PAP,

despite this cohort having the highest baseline PAP.

Conclusions: Heart failure hospitalization rates were most effectively reduced by a management strategy based

on pulmonary artery pressures without reliance upon clinical changes. This supports the strategy of early

intervention prior to clinical signs to avert clinical decompensation and heart failure readmissions.

(http://files.abstractsonline.com/CTRL/ff/4/450/68f/ac9/47a/78f/fad/6dd/227/163/0b/g7186_1.jpg)

$ Add To Itinerary

Goldberg LR et al, HRS 2015

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Conclusions

• Most HF hospitalizations are due to congestion

• Monitoring PAP/PAWP can identify impending events prior to weight gain

or worsening symptoms

• CardioMEMS can effectively reduce hospitalizations for heart failure when:

• Patients are well-selected

• The office is equipped to handle the increased volume

• A clear treatment algorithm based on hemodynamic data is used

• Don’t just go by clinical signs/symptoms, use the complete picture

• Ongoing post-approval CardioMEMS registry will provide valuable insights

to real world benefits and limitations of hemodynamic monitoring