12/18/15  

1  

Liviu Klein MD, MS Associate Professor Director, Mechanical

Circulatory Support and Heart Failure Device

Programs

Liviu.Klein@ucsf.edu

Value of Continuous Monitoring of

Pulmonary Artery Pressures in Heart

Failure

2

Financial Relationship Disclosure

I will NOT discuss off label/ investigational use of products.

The following financial relationships exist: Employer: University of California San Francisco. Current research support: CVRx, Department of Health and

Human Services, National Institutes of Health, Novartis, St. Jude Medical, Sunshine Heart.

Consultant: Boston Scientific, HeartWare, InfoBionic, Microsoft, Otsuka, St. Jude Medical, Thoratec.

Honoraria: None. Stockholder: InfoBionic.

Value of Continuous Monitoring of Pulmonary Artery Pressures in Heart Failure

12/18/15  

2  

3

Heart Failure Hospitalizations

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

4

High Post Discharge Mortality

Solomon SD et al. Circulation. 2007; 116: 1482-1487.

12/18/15  

3  

Dharmarajan K et al. JAMA. 2013; 309: 355-363.

Heart Failure ReHospitalizations

6

Heart Failure ReHospitalizations

Dharmarajan K et al. JAMA. 2013; 309: 355-363.

12/18/15  

4  

Heart Failure Signs/ Symptoms in Hospitalized Patients

Admission Discharge Symptoms (%) Dyspnea on exertion 79 58 Dyspnea at rest 42 5 Orthopnea 50 12 PND 33 4 Fatigue 53 57

Signs (%)

JVP > 8 cm 33 6 Rales 57 13 S3 gallop 20 6 Edema > 2+ 50 13

Gattis WA et al. J Am Coll Cardiol. 2004; 43: 1534-1540.

•  Among pts. with severe heart failure 1

–  PCWP 33 ± 6 mmHg, CI 1.8 ± 0.5, LVEF 0.18 ± 0.06 –  CXR: 27% no congestion, 41% minimal congestion

•  Among pts. with moderate heart failure 2

–  PCWP 30 ± 9 mmHg, CI 2.1 ± 0.8, LVEF 0.18 ± 0.06 –  No rales 84%, no edema 80%, no JVP 50%, no orthopnea

22% •  Hemodynamic congestion may not be

recognized clinically (doesn’t translate into symptoms/signs) until too late

Congestion Does not Translate in EARLY Signs/Symptoms

1 Mahdyoon H et al. Am J Card. 1989; 63: 625-630. 2 Stevenson LW et al. JAMA. 1989; 261: 884-889.

12/18/15  

5  

Ability to Predict High PWP Sens. Spec. PPV NPV

Dyspnea on exertion 66 52 45 27 Orthopnea 66 47 61 37 Edema 46 73 79 46 JVD 70 79 85 62 S3 73 42 66 44 CXR Cardiomegaly 97 10 61 --- Redistribution 60 68 75 52 Interstitial edema 60 73 78 53 Pleural effusion 43 79 76 47

Adapted from Chakko S. et al. Am J Med. 1991; 90: 353-358. Adapted from Butman SM. Et al. J Am Coll Cardiol. 1993; 22: 968-975.

Abnormal LV function (Sys and/or Dia)

Neurohormonal activation => ↑ Blood volume ↑ LV diastolic pressure

Hemodynamic congestion (Increased PWP)

Alveolar edema

↑ PA Pressure

↑ RV + RA Pressure

Systemic congestion (Leg edema; JVD; Hepatomegaly)

S

Y

M

P

T

O

M

S

The Congestion Iceberg in Heart Failure

Redistribution in pulmonary vascular bed + interstitial edema

↑ Hydrostatic pressure ↑ Oncotic pressure ↑ Permeability Lymphatic drainage capacity Alveolar-capillary membrane integrity

Abnormal lung mechanics Respiratory muscle dysfunction Other factors

Dyspnea

12/18/15  

6  

Main Reasons for Broken Care Symptoms worsen Patient

MD Office

ED

Hospitalization

Readmission

Doesn’t recognize early signs and symptoms

Limited time Limited staff Limited diagnostics Limited monitoring Limited intervention Limited patient education

Only alternative ED MD with no patient relationship Safest route medically and legally

Pressure on length of stay shortens time to test new medication regimen or educate

Symptoms worsen Reactive Care

Standard of Care for Heart Failure in 2015

12/18/15  

7  

13

Weights and Heart Failure Hospitalizations

Chaudhry SI et al. Circulation. 2007; 116: 1549-1554.

14

Weights and Non Heart Failure Hospitalizations

Chaudhry SI et al. Circulation. 2007; 116: 1549-1554.

12/18/15  

8  

15

Lynga P et al. Eur J Heart Fail. 2012; 14: 438-444.

16

Lynga P et al. Eur J Heart Fail. 2012; 14: 438-444.

Weights and Heart Failure Hospitalizations

12/18/15  

9  

Main Reasons for Broken Care Symptoms worsen Patient

MD Office

ED

Hospitalization

Readmission

Doesn’t recognize early signs and symptoms

Limited time Limited staff Limited diagnostics Limited monitoring Limited intervention Limited patient education

Only alternative ED MD with no patient relationship Safest route medically and legally

Pressure on length of stay shortens time to test new medication regimen or educate

Symptoms worsen Proactive Care

18

Chaudhry SI et al. New Engl J Med. 2010; 363: 2301-2309.

Telemonitoring and HF Hospitalizations: TELE-HF

12/18/15  

10  

19

Ong M. AHA 2015.

Telemonitoring and Heart Failure : BEAT HF

20

Ong M. AHA 2015.

Telemonitoring and Heart Failure : BEAT HF

12/18/15  

11  

21

Ong M. AHA 2015.

Telemonitoring and Heart Failure : BEAT HF

Telemonitoring and Readmissions

12/18/15  

12  

Main Reasons for Broken Care Symptoms worsen Patient

MD Office

ED

Hospitalization

Readmission

Doesn’t recognize early signs and symptoms

Limited time Limited staff Limited diagnostics Limited monitoring Limited intervention Limited patient education

Only alternative ED MD with no patient relationship Safest route medically and legally

Pressure on length of stay shortens time to test new medication regimen or educate

Symptoms worsen Directed Care

Hemodynamic

24

Hemodynamics and Outcomes

Fonarow GC et al. Circulation 1994; 90: I-488

PCWP > 16 mm Hg

PCWP < 16 mm Hg

CI > 2.6 L/min/m2

CI < 2.6 L/min/m2

Mortality Risk (%) Mortality Risk (%)

0 6 12 18 24 0

10

20

30

40

50

60

0 6 12 18 24 0

10

20

30

40

50

60

Time (months)

P = NS

P = 0.001

12/18/15  

13  

25

Congestion Precedes Most Heart Failure Hospitalizations

Zile MR et al. Circulation. 2008; 118: 1433-1441.

26

Congestion Precedes Most Heart Failure Hospitalizations

Zile MR et al. Circulation. 2008; 118: 1433-1441.

12/18/15  

14  

Nitinol Loops •  10 mm diameter •  Maintain sensor position in vessel

Fused silica housing with

silicone coating Inductor coil

Pressure sensitive capacitor

Heart Failure Pressure Sensor Sensor •  No battery •  No leads •  Small size (3.5 x 2 x 15mm)

CardioMEMS™ HF System

PA Sensor and Delivery System

120 cm 4.5 cm

Patient Electronics System

PA Pressure Database

Physician Access Via Secure Website

12/18/15  

15  

29

Flow around sensor

No Impact on Blood Flow

Sensor in Distal PA

12/18/15  

16  

Abraham WT et al. Am Heart J. 2011; 161: 558-566.

Accuracy of PA Measurements

12/18/15  

17  

Abraham WT et al. Lancet. 2011; 377: 658-666.

CHAMPION Trial

Abraham WT et al. Lancet. 2011; 377: 658-666.

CHAMPION Trial

12/18/15  

18  

Abraham WT et al. Lancet. 2011; 377: 658-666.

CHAMPION Trial

Abraham WT et al. Lancet. 2015; in press.

CHAMPION Trial – Long Term

12/18/15  

19  

Abraham WT et al. Lancet. 2015; in press.

CHAMPION Trial – Long Term

Abraham WT et al. Lancet. 2015; in press.

CHAMPION Trial – Long Term

12/18/15  

20  

Goldberg LR et al. HRS 2015

CHAMPION Trial: Symptoms vs. PAP Management

A Year Later @ UCSF

12/18/15  

21  

• Congestion is the lead cause of HF hospitalizations • Congestion contributes to progression of HF • Patients leave hospital with congestion, resulting in

high rehospitalization rate • Congestion is often subclinical and difficult to assess

when present • Significant dissociation between hemodynamic and

clinical congestion, even when hemodynamics are very abnormal • Need for better monitoring of degree and changes in

congestion (more accurate and sensitive)

Congestion in Heart Failure

Conclusions •  Monitoring PAP/ PWP can provide early

warning of condition worsening/ decompensation much better than body weight and before symptoms

•  Most changes occur over a few days - weeks •  Having a treatment algorithm based on PAP/

PWP values is key to successful treatment and preventing heart failure readmissions

•  Always treat to max: drive pressures down to patient’s normal