Remote Monitoring of Pulmonary Artery Pressures

Transcription

1 Remote monitoring of pulmonary artery pressures Remote monitoring of pulmonary artery pressures UCSD Hawaii Symposium 2017 Remote Monitoring of Pulmonary Artery Pressures Gregg C. Fonarow, MD, FAHA, FACC The Eliot Corday Professor of Cardiovascular Medicine and Science Professor of Medicine, UCLA Division of Cardiology Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief, UCLA Division of Cardiology Los Angeles, California

2 Presenter Disclosure Information I will discuss off label use of medications or devices The following relationships exist related to this presentation: Gregg C. Fonarow, MD, FACC, FAHA NHLBI, AHRQ, Novartis, Medtronic (research)

3 With Current Management of Heart Failure Patients.. Close to 1 million hospitalizations for heart failure as primary discharge diagnosis in US Over 300,000 deaths a year and mortality rates that remains at 50% at 5 years from diagnosis Nearly one in four patients hospitalized with HF is rehospitalized within 30 days of discharge The 30 day risk-standardized rehospitalization rates in HF have risen from 17.3% in 1993 to 24.0% in 2016 Between 12 to 15 million outpatient office visits Direct costs of over 30 billion dollars a year

4 Affordable Care Act Up to 3% cut to all DRGs for readmissions over the expected % Up to 1% in fiscal year 2013, 2% in fiscal year 2014, and 3% in fiscal year 2015 and beyond Initially AMI, heart failure, and pneumonia Expanded to COPD, hip fractures in year decrease in reimbursement to hospitals $7.1 billion The proposed prospective payment systems began October 1 st 2012 (beginning of fiscal year 2013) Medicare Penalizing 2,211 Hospitals For Excess Readmissions

5 Challenges in Managing Patients With Heart Failure Monitoring for congestion is a challenge Monitoring for changes in cardiac function and hemodynamics is a challenge Monitoring for changes in symptoms and functional status is a challenge Monitoring dietary adherence is a challenge Monitoring medication adherence is a challenge Optimal titration of HF medications is a challenge Detecting arrhythmias is a challenge

6 Importance of Recognizing Congestion The majority of heart failure hospitalizations are due to congestion In chronic heart failure, LV filling pressures (even severe) infrequently cause rales and acute pulmonary edema 1,2 Recognizing hemodynamic congestion is challenging Identifying congestion early will lead to early treatment, and possibly prevent progression of heart failure and hospitalizations 1 Mahdyoon H et al. Am J Card. 1989; 63: Stevenson LW et al. JAMA. 1989; 261: 884

7 High PCWP at Hospital Discharge is Associated with Higher Mortality in HF 60 Mortality (%) 60 Mortality (%) PCWP > 16 mmhg N=199 P = CI > 2.6 L/min/m 2 N= PCWP < 16 mmhg N= P = NS CI < 2.6 L/min/m 2 N= Time (months) Time (months) Fonarow GC et al. Circulation 1994; 90: I-488

8 ACC/AHA HF Guidelines Serial Clinical Assessment I IIa IIb III Assessment should be made at each visit of the volume status and weight of a patient with HF Hunt SA, et al. ACC/AHA 2005 Practice Guidelines. Available at

9 Common Signs and Symptoms of Congestion Signs Jugular venous distention/elevation Peripheral edema Pulmonary congestion / rales Pleural effusions S3 gallop Symptoms Dyspnea on exertion Orthopnea Paroxysmal nocturnal dyspnea Fatigue Abdominal fullness Anorexia, nausea, vomiting

10 Absence of Specific Signs, Symptoms and CXR Findings Doesn t Exclude High PCWP Ability to predict PCWP > mmhg in patients with heart failure 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: 353 Adapted from Butman SM. Et al. J Am Coll Cardiol. 1993; 22: 968

11 Poor Sensitivity of Weight and/or BNP Changes Prior to Clinical Decompensation Sensitivity Specificity > 2 Kg Weight Gain over hours 9% 97% > 2% Weight Gain over hours 17% 94% > 100 pg/ml increase in BNP 47% 77% Lewin J et al. Eur J Heart Fail 2005;7:953-7.

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13 Ahmanson-UCLA Cardiomyopathy Center Comprehensive HF Disease Management Program UCLA Multidisciplinary Team: Advance Practice Nurses, HF Specialists, CT Surgery, MSW, Others Comprehensive assessment Optimization of heart failure treatment regimen Detailed patient and family education Daily measuring and recording of weights Sodium restricted diet with detailed guidelines Two liter (64 oz) fluid restriction (if congestion) Patient self-monitored flexible-loop diuretic regimen Alcohol and smoking abstinence Progressive walking exercise program Vigilant monitoring, care coordination, and follow-up by advance practice nurses and physicians Fonarow GC et al. J Am Coll Cardiol. 1997;30:

14 HF Disease Management Program: Impact on Treatment and Hospitalizations ACE Inhibitor Use Patients (%) 77 Conventional Management 6 Months Pre-comprehensive *P=0.05 vs conventional management 95 * 92* HF Management System at Discharge HF Management 6 Months Post-comprehensive Cumulative Hospitalizations (6 months) Conventional Care Postcomprehensive Rx 63 85% Reduction in Hospitalizations P< Patients, 6 months conventional treatment pre- vs 6 months post-comprehensive management. Total medical costs: Pre ($18,808) vs Post ($9,555), P< Fonarow GC. et al. J Am Coll Cardiol. 1997;30:

15 Randomized Trials of Disease Management Programs for Heart Failure Sensitivity analysis Mortality All-cause readmission HF-related readmission OR CI OR CI OR CI Overall High quality studies Low quality studies Multidisciplinary Nurse Short intervention (0 3 m) Medium intervention (3 6 m) Long intervention (> 6 m) Randomized Trials, 5308 patients Roccaforte EJHF 2005;7: P <0.01

16 Benefits and Drawbacks of Heart Failure Disease Management Programs Benefits Improved use of evidencebased therapy Improved symptom status and functional capacity Usual Care 96% Drawbacks Improved QOL Reduction in hospitalization Decrease in total medical costs Improved survival suggested in some studies 4% HF Disease Management Programs Moser DK, Mann DL. Circulation. 2002;105:

17 Telemonitoring in Patients with Heart Failure: Tele-HF and BEAT-HF 1653 patients who had recently been hospitalized for HF randomized to undergo either telemonitoring (826 patients) or usual care (827 patients) patients hospitalized with HF randomized to test effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause hospitalization Chaudhry SI, et al N Engl J Med. 2010;363: Ong, M et al. JAMA Intern Med. 2016;176(3):

18 Cardiac Implantable Electronic Devices Pacemaker (PM) Implantable Cardioverter-Defibrillator (ICD) Cardiac Resynchronization Therapy (CRT) Implantable Hemodynamic Sensors and Monitoring (IHM) 18

19 Device Based Monitoring in Patients with Heart Failure Direct Data Heart Rate Atrial/Ventricular Arrhythmias % pacing Device Parameters Battery Alerts Leads Calculated (Derived) Data Heart Rate Variability Intrathoracic Impedance Activity Pressure Sensor Data Left atrial Pulmonary artery RV outflow

20 Implantable Devices May Offer a Reliable Means to Monitor Fluid Status Objectively track fluid accumulation and/or hemodynamics longitudinally over time Multiple measurement per day are averaged to give a truer picture of that day s trends Acute changes are compared to the patient s own expected baseline No compliance issues as with patient weights Has the potential to substantially improve clinical outcomes in heart failure patients

21 Congestion Precedes Hospitalization Pressure Change Hospitalization Change (%) RV Systolic Pressure Estimated PA Diastolic Pressure Heart Rate Baseline Recovery Days Relative to the Event Adamson PB et al. J Am Coll Cardiol. 2003; 41: 565

22 Implantable Hemodynamic Monitors RV Pressure Sensors LV Pressure Sensor PA Pressure Sensors LA Pressure Sensors

23 Implantable Hemodynamic Monitoring to Guide Heart Failure Care: COMPASS-HF 100% Chronicle (n =134) Control (n = 140) Freedom from HF-related hospitalization 80% 60% 40% 20% Chronicle Control RR = 0.79 (95%CI = ) p=0.029 # of Pts with Events Total HF Related Events Hospitalizations Emergency Department Visits 9 11 Urgent Clinic Visits 2 2 Event Rate / 6months* % % Reduction in Event Rate 22% (p=0.27) % non-significant trend for reduction in the relative risk of HF hospitalization. (p=0.27) 33% reduction in the proportion of patients with worsening HF. 22% reduction in HF events overall. 41% reduction in HF-related events among patients with NYHA class 3 HF. (p=0.03) Bourge RC et al. J Am Coll Cardiol, 2008; 51:

24 Ambulatory Hemodynamics and Heart Failure Events Relationship between chronic intracardiac pressures and later heart failure events The HF patient group median for chronic 24-hour estimated PA diastolic pressure was 28 mmhg Despite weight-guided management, HF events occurred in 100/261 (38%) patients Event risk increased progressively with higher chronic 24 hour epad Events increased from 20% at 18 mmhg to 34% at 25 mmhg and 56% at 30 mmhg 261 Class III-IV HF patients enrolled in COMPASS-HF Stevenson et al. CIRCHEARTFAILURE

25 Intra-Cardiac Pressures in Patients With and Without HF Events 35 With Events Without Events epad Daily Mean (mmhg) ± ± ± ±5.9 p<0.001 p< n=42 n=82 n=56 n=74 CHRONICLE CONTROL Stevenson LW, et al. Circ Heart Fail Sep;3(5):580-7.

26 Implantable Wireless Heart Sensor No batteries or internal power source, sensor is powered by RFenergy provided by an external electronics module. Coil and a pressure sensitive capacitor encased in a hermetically sealed silica capsule covered by silicone. The device has no leads or batteries. Two nitinol loops at the ends of the capsule serve as anchors in the pulmonary artery. The coil and capacitor form an electrical circuit that resonates at a specific frequency, and pressure applied to the sensor causes deflections of the pressure-sensitive surface. An external antenna provides power to the device, continuously measuring its resonant frequency, which is then converted to a pressure waveform. The interrogating device has an atmospheric barometer which automatically subtracts the ambient pressure from that measured from the implanted sensor.

27 Wireless Pulmonary Artery Hemodynamic Monitoring in Chronic Heart Failure: CHAMPION Abraham WT, et al Lancet Feb 19;377(9766):

28 Wireless Pulmonary Artery Hemodynamic Monitoring in Chronic Heart Failure: CHAMPION 550 patients with NYHA Class III HF, irrespective of LVEF, and a previous HF hospital admission were enrolled in 64 centers the US Randomly assigned to management with a wireless implantable hemodynamic monitoring (W-IHM) system (treatment group) or to a control group for at least 6 months Clinicians used daily measurement of pulmonary artery pressures in addition to standard of care versus standard of care alone in the control group, with goal of keeping PAD pressures normal and specific recommendations provided The primary efficacy endpoint was the rate of HF related hospitalizations at 6 months Abraham WT, et al Lancet Feb 19;377(9766):

29 Wireless Pulmonary Artery Hemodynamic Monitoring in Chronic Heart Failure: CHAMPION Abraham WT, et al Lancet Feb 19;377(9766):

30 Other Findings from CHAMPION Mean PAP fell substantially over 6 months in the sensor-guidedtherapy group and rose in the control group (p=0.008). Quality of life at six months, as assessed by the MLWHFQ, was better in the PAP-guided therapy group (p=0.024). The length of stay for HF-related hospitalizations was significantly shorter in the treatment group than in the control group (2.2 days [SD 6.8] vs 3.8 days [11.1], p=0.02). Significant reduction in the rate of HF-related hospitalizations for preserved (0 16 vs 0 33, p<0 0001) and reduced systolic function (0 36 vs 0 47, p=0 007) patients during 6 months. Incremental cost-effectiveness ratio of integrating W-IHM into standard of care for management of the HF is estimated to be $13,979 per QALY gained. Abraham WT, et al Lancet Feb 19;377(9766):

31 Pulmonary Artery Pressure Guided HF Management Reduces 30-Day Readmissions 245 Medicare-eligible subjects in the CHAMPION Trial Circ Heart Fail. 2016;9:e Day All Cause Readmission HR 0.42, 95% CI ; P=0.008

32 Interventions Linked to Decreased Heart Failure Hospitalizations During Ambulatory Pulmonary Artery Pressure Monitoring (J Am Coll Cardiol HF 2016

33 Clinical Practice Data with CardioMems At implant, the mean PA pressure for the general-use patients was 34.9±10.2 mmhg, compared with 31.3±10.9mmHg for CHAMPION treatment and 32.0±10.5mmHg for CHAMPION control groups. The general-use patients had an AUC of -32.8mmHg days at the 1 month time mark, mmHg days at the 3 month time mark and mmHg days after 6 months of hemodynamic guided care, which was significantly lower than the treatment group in the CHAMPION Trial. Patients consistently transmitted pressure information with a median of 1.27 days between transmissions after 6 months. Conclusions The first 2,000 general-use patients managed with hemodynamic guided HF care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared to the pivotal CHAMPION Clinical Trial. Circulation. 2017;CIRCULATIONAHA

34 Clinical Practice Data with CardioMems

35 New Opportunity for Enhanced Management of HF Usual Care Hemodynamic Monitored and Guided Care Daily Monitoring PRN Assessments Visits Therapy Weight, symptoms Physical examination, laboratories, echocardiogram Patient regularly scheduled office visits 2-12 times a year PRN calls, unscheduled office visits, ER visits if worsened symptoms Empiric and/or reactive adjustments in therapy Weight, symptoms hemodynamics Less frequent need for physical exam, laboratories, echocardiogram Opportunity for remote visits Office visits only when needed Less need for unscheduled office visits and ER visits Proactive, guided, personalized adjustments in therapy Bui A, Fonarow GC, JACC 2012;59:97-104

36 Wireless Communication Between Implantable Devices and Clinicians Home Monitoring of Implanted Devices Customized Alert Parameters and Notification Options

37 Potential Benefits of Implantable Device Based Remote Monitoring Less patient time and transportation time Less physician time Greater certainty in assessment for congestion Better patient comfort and health status Continuous monitoring with improved patient safety and quality of care Immediate recognition of device-related problems Immediate recognition of serious arrhythmias Immediate recognition of worsened heart failure

38 Beware: Device Information Overload! Organized approach to using data clinically Arrhythmias / Therapies Thresholds / Battery Heart Rates / Rate Response Patient Activity Heart Rate Variability % Pacing Volume Indicators

39 Tiered Device Notifications Urgent Alerts Battery depletion Abnormal lead impedance Abnormal shock lead impedance Low RV intrinsic amplitude High voltage detected on shock lead Mode change Possible device malfunction Semi-Urgent Alerts Shock therapy delivered Accelerated arrhythmia episodes ATR > 24 hours Patient triggered event stored Abnormal fluid/congestion monitoring signals Abnormal, but non-urgent lead values

40 Hemodynamic Guidance to Self Manage Heart Failure: Overview Change in Therapy Implemented Wireless Hemodynamic and Other Data Analyzed by Implanted or Networked Device Data Transmitted Clinical Alert Generated HF Patient at Home Clinician Patient uses guided therapy to self-titrate HF meds Bui A, Fonarow GC, JACC 2012;59: Treatment Plan Communicated Data Analyzed, Interpreted, and Treatment Plan Formulated

41 Potential for Physiologic Based Therapeutic Management of HF Elevation in LV filling pressure Detection by Implanted Sensor Analyzed by Implanted or Networked Device Treatment Command to Implanted Infusion Pump Normalization in LV filling pressure Infusion of Therapy (Diuretic and/or Vasodilator) Bui A, Fonarow GC, JACC 2012;59:97-104

42 Medication Compliance in Heart Failure Adherence to prescribed medical therapies are low with many studies suggesting 50% or more HF patients do not take medications as directed Medication non-adherence associated with substantial increased risk of hospitalization Medication non-adherence associated with substantial increased risk of mortality Patients with heart failure are frequently on a complex and challenging medication regimen Monitoring medication persistence and adherence remains a challenge

43 Devices to Monitor HF Medication Compliance System to sense and record the precise times patients take microchip-enabled HF medications Edible sensor embedded in each HF pill Low-powered signal triggered when sensor minerals mix with stomach, detected by receiver Scientific American May 25, 2010 Device sends alerts to patient, caregivers, clinicians if any doses are missed

44 Devices for Providing Personalized Patient Education Hello Mr Jones, Have you missed any doses of your medications? Sodium restricted diet Daily activities Signs and symptoms to look for Medication adherence Spacing of medications Positive motivation Keeping appointments Hello Dave, When are you planning to take your morning dose of carvediol? As we discussed before beta blockers lower your risk of adverse outcomes

45 Monitoring Patients with Heart Failure HF continues to result in substantial morbidity, mortality, and health care expenditures Certain HF disease management programs have been effective Recent clinical trial evidence trials demonstrate that chronic ambulatory hemodynamic monitoring improves health status and substantially reduces hospitalizations compared to usual HF care Studies are evaluating patient self care guided by device diagnostics Potential for device monitoring to improve adherence