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New Approaches to Monitoring Heart Failure Before Symptoms Appear

New Approaches to Monitoring Heart Failure Before Symptoms Appear. William T. Abraham, MD, FACP, FACC Professor of Medicine Chief, Division of Cardiovascular Medicine Associate Director, Davis Heart & Lung Research Institute The Ohio State University Columbus, Ohio.

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New Approaches to Monitoring Heart Failure Before Symptoms Appear

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  1. New Approaches toMonitoring Heart Failure Before Symptoms Appear William T. Abraham, MD, FACP, FACC Professor of Medicine Chief, Division of Cardiovascular Medicine Associate Director, Davis Heart & Lung Research Institute The Ohio State University Columbus, Ohio

  2. Can Implantable Monitors Predict Worsening Heart Failure? Asymptomatic fluid retention Change in impedance or pressure Worsening heart failure Can this prevent hospitalization for worsening heart failure?

  3. Intrathoracic Impedanceas a Measure ofHeart Failure Clinical Status

  4. Impedance Decreases With Increasing Lung Wetness Impedance “Wetter” Lungs

  5. Impedance Prior to CHF Admission 90 Reference Baseline 80 More Fluid Less 70 Impedance (W) Impedance Reduction 60 Duration of Impedance Reduction -28 -21 -14 -7 0 Days Before Hospitalization CHF, congestive heart failure.

  6. Animal studies Completed MID-HeFT study: Medtronic Impedance Diagnostics in Heart Failure Trial Ongoing FAST study: Fluid Accumulation Status Trial Evidence Supporting the Useof Intrathoracic Impedance

  7. MID-HeFT Study • MIDHeFT study • 33 patients, 628 months of follow-up (as of 9/1/03) • 25 hospitalizations for fluid overload from 10 patients • Demonstrated an inverse correlation between impedance and both PCWP and net fluid I/O in patients hospitalized for fluid overload • Demonstrated consistent decreases in impedance in the days preceding hospitalization (ie, predicted hospitalization!) PCWP, pulmonary capillary wedge pressure; I/O, in/out. Yu C-M, et al. Circulation. 2005;112:841-848.

  8. MID-HeFT Study Results • Intrathoracic impedance decline preceded the onset of symptoms by mean lead time of 10.3 days (P<0.0001) • Retrospective analysis of the clinical data showed that intrathoracic impedances gradually decreased over approximately 2 weeks prior to HF hospitalization (14 days, P<0.0001) with a total reduction of 11.3% • Using a single detection threshold for all patients, the OptiVol algorithm would have detected 76% of admissions for fluid overload, with an average of only one false warning for every 322 days of patient monitoring HF, heart failure Yu C-M, et al. Circulation. 2005;112:841-848.

  9. Example: Fluid Status During Diuresis 70 65 Impedance (W) 60 55 30 PCWP (mm Hg) 20 10 0 -2 Fluid I/O (liters) -4 -6 0 1 2 3 4 Days In Hospital

  10. Impedance Leading Up To Admission (n=24) -12.3 +/- 5.3% (P<0.001) 90 80 70 Impedance (W) 60 50 Reference Baseline One Day Prior to Admission 18.3 +/- 10.1 Days

  11. Impedance Decline Precedes Symptoms (n=20) 40 30 Days Prior to Admission 20 10 0 Symptom Onset Impedance Decline

  12. Automated Detection of Decreases in Intrathoracic Impedance That Precede Hospitalization for CHF

  13. OptiVol Feature P P 200 OptiVolFluid Index OptiVol Threshold Physician- programmed threshold 160 120 Accumulation of the difference between the daily and reference impedance 80 40 Fluid 0 Jun 98 Aug 98 Oct 98 Thoracic Impedance (ohms) Daily Reference >120 Reference impedance slowly adapts to daily impedance 110 100 Daily impedance is the average of one day’s measurements 90 80 70 60 Jun 98 Aug 98 Oct 98 P, program.

  14. Overview of Detection Algorithm 100 60 Fluid Index (W days) 20 0 40 80 120 160 200 0 Days 90 80 Impedance (W) 70 0 0 40 80 120 160 200 Days

  15. FAST Study • FAST study • 44 patients enrolled/downloaded • 47 months of total follow-up • 32 patients to 1 month • 7 patients with an HF event; 25 were event-free • 3 clinically relevant HF hospitalizations (in 2 patients)* • 11 clinically relevant HF medication changes (in 5 patients)* • 4 adverse events from HF medication changes (in 4 patients)* • Study corroborated impedance performance from the MID-HeFT study in both event-free and HF event occurrences *Patients with events are not mutually exclusive.

  16. FAST Case Study 2 – HF Event Patient 110270001 70 H H H H H H H 60 M M M M M M 50 Impedance 40 F F 30 0 10 20 30 40 50 60 70 80 90 100 Days Discharged after 1.5 lbs of diuresis Discharged after 10.8 lbs of diuresis H H H H H H H M M M M M M 120 90 Cumulative Diff 60 F F 30 0 0 10 20 30 40 50 60 70 80 90 100 Days Threshold crossed 19 days prior to hospitalization. 300 290 Weight (lbs) 280 270 F F 260 0 10 20 30 40 50 60 70 80 90 100 Days H, hospitalization; O, outpatient visit; M, medication change; F, protocol scheduled follow-up.

  17. InSync Sentry™ Case: Loss of CRT Sept. 29: Crossed OptiVol fluid threshold. Oct. 28: Hospitalization for decompensation: orthopnea, peripheral edema, and crackles in lower lungs. Nov. 5: Lead replacement. Impedance stabilizes several days after procedure. >200 OptiVolFluid Index OptiVol Threshold 160 120 80 Oct. 7: LV lead dislodgement observed. Decided to reposition lead in November. 40 0 Fluid Sep 04 Nov 04 >100 Thoracic Impedance (ohms) Daily Reference 90 80 70 60 50 40 CRT, cardiac resynchronization therapy. Sep 04 Nov 04

  18. InSync Sentry Case:Precipitous Drop in Impedance >200 OptiVolFluid Index OptiVol Threshold 160 120 80 40 0 Fluid Aug 04 Oct 04 Dec 04 >100 Thoracic Impedance (ohms) Daily Reference 90 80 70 60 50 40 Aug 04 Oct 04 Dec 04

  19. InSync Sentry Case:Precipitous Drop in Impedance >100 Thoracic Impedance (ohms) Daily Reference 90 80 70 60 50 40 Aug 04 Oct 04 Dec 04 24 AT/AFTotal hours/day 20 16 12 8 4 0 >200 V. rate during AT/AF (bpm) Max/day Avg/day 150 100 AT, atrial tachycardia; AF, atrial fibrillation; V. rate, ventricular rate. <50

  20. Implantable Hemodynamic Monitoring Systems

  21. Implantable Hemodynamic Monitor

  22. IHM System and Information Flow IHM Home Monitor Secure Network Clinician Access • RV systolic pressure • RV diastolic pressure • Estimated PA diastolic pressure • Other parameters IHM, implantable hemodynamic monitor; RV, right ventricular; PA, pulmonary artery.

  23. IHM-Guided Care Reduces Worsening HF in NYHA Class III Patients Cumulative Events BCA 120 TCA 100 80 Events 60 40 20 0 2 6 4 Months NYHA, New York Heart Association; BCA, blocked clinician access; TCA, total clinician access. Bourge RC, et al. ACC 2005.

  24. IHM Case Study • 59-year-old white female with ICM • S/P AWMI 2001; CABG 4 SVG 2001 • Participant in COMPASS-HF Trial (BCA) • Called 5 days after Valentine’s Day 2005 due to bloating and increased shortness of breath • Weight “stable” • Asked to transmit data ICM, ischemic cardiomyopathy; AWMI, anterior wall myocardial infarction; CABG, coronary artery bypass graft; SVG, saphenous vein graft; BCA, blocked clinician access.

  25. RV Diastolic Pressure (mm Hg) RV Systolic Pressure (mm Hg) ePAD (mm Hg) ePAD, estimated pulmonary artery diastolic pressure.

  26. IHM Case Study • Had celebrated Valentine’s Day by going out to eat • At an Indian restaurant! • Very thirsty – increased fluids • Diuretics increased

  27. Summary • Long-term trends in intrathoracic impedance may provide an early warning of impending episodes of decompensation in outpatients • Implantable hemodynamic monitoring (IHM) enables the day-to-day management of ventricular filling pressures in CHF patients • Intrathoracic impedance and IHM represent complimentary and promising new technologies for the management of HF

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