Value of Continuous Monitoring of. Pulmonary Artery Pressures in Heart Failure. Financial Relationship Disclosure. Liviu Klein MD, MS

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1 Liviu Klein MD, MS Associate Professor Director, Mechanical Circulatory Support and Heart Failure Device Programs Value of Continuous Monitoring of Pulmonary Artery Pressures in Heart Failure Financial Relationship Disclosure Value of Continuous Monitoring of Pulmonary Artery Pressures in Heart Failure 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. 2 1

2 Heart Failure Hospitalizations Go AS et al. Circulation. 2014; 129: e28-e High Post Discharge Mortality Solomon SD et al. Circulation. 2007; 116:

3 Heart Failure ReHospitalizations Dharmarajan K et al. JAMA. 2013; 309: Heart Failure ReHospitalizations Dharmarajan K et al. JAMA. 2013; 309:

4 Heart Failure Signs/ Symptoms in Hospitalized Patients Admission Discharge Symptoms (%) Dyspnea on exertion Dyspnea at rest 42 5 Orthopnea PND 33 4 Fatigue Signs (%) JVP > 8 cm 33 6 Rales S3 gallop 20 6 Edema > Gattis WA et al. J Am Coll Cardiol. 2004; 43: Congestion Does not Translate in EARLY Signs/Symptoms 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 1 Mahdyoon H et al. Am J Card. 1989; 63: Stevenson LW et al. JAMA. 1989; 261:

5 Ability to Predict High PWP Sens. Spec. PPV NPV Dyspnea on exertion Orthopnea Edema JVD S CXR Cardiomegaly Redistribution Interstitial edema Pleural effusion Adapted from Chakko S. et al. Am J Med. 1991; 90: Adapted from Butman SM. Et al. J Am Coll Cardiol. 1993; 22: The Congestion Iceberg in Heart Failure S Y M P T O M S Systemic congestion (Leg edema; JVD; Hepatomegaly) RV + RA Pressure PA Pressure Alveolar edema Dyspnea Redistribution in pulmonary vascular bed + interstitial edema Hemodynamic congestion (Increased PWP) Neurohormonal activation => Blood volume LV diastolic pressure Abnormal LV function (Sys and/or Dia) Abnormal lung mechanics Respiratory muscle dysfunction Other factors Hydrostatic pressure Oncotic pressure Permeability Lymphatic drainage capacity Alveolar-capillary membrane integrity 5

6 Main Reasons for Broken Care Symptoms worsen Readmission Hospitalization Pressure on length of stay shortens time to test new medication regimen or educate Patient Doesn t recognize early signs and symptoms Limited time Limited staff Limited diagnostics Limited monitoring Limited intervention Limited patient education ED MD Office Reactive Care Only alternative ED MD with no patient relationship Safest route medically and legally Symptoms worsen Standard of Care for Heart Failure in

7 Weights and Heart Failure Hospitalizations Chaudhry SI et al. Circulation. 2007; 116: Weights and Non Heart Failure Hospitalizations Chaudhry SI et al. Circulation. 2007; 116:

8 Lynga P et al. Eur J Heart Fail. 2012; 14: Weights and Heart Failure Hospitalizations Lynga P et al. Eur J Heart Fail. 2012; 14:

9 Main Reasons for Broken Care Symptoms worsen Readmission Hospitalization Pressure on length of stay shortens time to test new medication regimen or educate Patient Doesn t recognize early signs and symptoms Limited time Limited staff Limited diagnostics Limited monitoring Limited intervention Limited patient education ED MD Office Only alternative ED MD with no patient relationship Safest route medically and legally Symptoms worsen Proactive Care Telemonitoring and HF Hospitalizations: TELE-HF Chaudhry SI et al. New Engl J Med. 2010; 363:

10 12/18/15 Telemonitoring and Heart Failure : BEAT HF Ong M. AHA Telemonitoring and Heart Failure : BEAT HF Ong M. AHA

11 12/18/15 Telemonitoring and Heart Failure : BEAT HF Ong M. AHA Telemonitoring and Readmissions 11

12 Main Reasons for Broken Care Symptoms worsen Readmission Hospitalization Pressure on length of stay shortens time to test new medication regimen or educate Patient Doesn t recognize early signs and symptoms Limited time Limited staff Limited diagnostics Limited monitoring Limited intervention Limited patient education ED MD Office Hemodynamic Directed Care Only alternative ED MD with no patient relationship Safest route medically and legally Symptoms worsen Hemodynamics and Outcomes Mortality Risk (%) PCWP > 16 mm Hg Mortality Risk (%) CI > 2.6 L/min/m 2 30 P = PCWP < 16 mm Hg 20 P = NS CI < 2.6 L/min/m Time (months) Fonarow GC et al. Circulation 1994; 90: I

13 Congestion Precedes Most Heart Failure Hospitalizations Zile MR et al. Circulation. 2008; 118: Congestion Precedes Most Heart Failure Hospitalizations Zile MR et al. Circulation. 2008; 118:

14 Heart Failure Pressure Sensor Sensor No battery No leads Small size (3.5 x 2 x 15mm) Nitinol Loops 10 mm diameter Maintain sensor position in vessel Pressure sensitive capacitor Fused silica housing with silicone coating Inductor coil CardioMEMS HF System PA Sensor and Delivery System 4.5 cm 120 cm Patient Electronics System PA Pressure Database Physician Access Via Secure Website 14

15 No Impact on Blood Flow Flow around sensor Sensor in Distal PA 29 15

16 Accuracy of PA Measurements Abraham WT et al. Am Heart J. 2011; 161:

17 CHAMPION Trial Abraham WT et al. Lancet. 2011; 377: CHAMPION Trial Abraham WT et al. Lancet. 2011; 377:

18 CHAMPION Trial Abraham WT et al. Lancet. 2011; 377: CHAMPION Trial Long Term Abraham WT et al. Lancet. 2015; in press. 18

19 CHAMPION Trial Long Term Abraham WT et al. Lancet. 2015; in press. CHAMPION Trial Long Term Abraham WT et al. Lancet. 2015; in press. 19

20 CHAMPION Trial: Symptoms vs. PAP Management Goldberg LR et al. HRS 2015 A Year UCSF 20

21 Congestion in Heart Failure 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) 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 21

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