1. Integrating Monitoring into the Infrastructure and Workflow of Routine Practice: OptiVol Roy S. Small, MD, FACC Director, Heart Failure Clinic, The Heart Group Medical Director, Heart Failure Service Lancaster General Hospital Lancaster, Pennsylvania

2. 2 Preventing Hospitalizations for Heart Failure  Congestion is the primary reason for heart failure admissions  Signs and symptoms of congestion do not necessarily reflect fluid status  Daily weights are helpful but not reliable predictors of fluid status  Currently available noninvasive markers of congestion are unreliable

3. 3 CARE-HF: Primary Endpoint (All-Cause Mortality or Unplanned Hospitalization for Major CVS Event) 348118232292404 Medical Therapy 768166273323409 CRT Number at risk 050010001500 0.00 0.25 0.50 0.75 1.00 Event-Free Survival P<0.001 CRT Medical therapy CARE-HF, CArdiac REsynchronisation in Heart Failure study; CVS, cardiovascular system. Cleland JG, et al. N Engl J Med. 2005;352:1539-1549. Days

4. 4 Device Diagnostics: One More Piece of the Puzzle

5. 5 CRT in Lancaster  First CRT implant (11.13.’98)  >1,261 CRT device implants to date Sentry in Lancaster  First Sentry implant (12.29.’04)  183 Sentry device implants (01.’06)  Cardiosight initiated (12.’05)  Patients routinely followed in CHF clinic CR, cardiac resynchronization therapy; CHF, congestive heart failure.

6. 6 Current Medicare criteria for CRT Future considerations for fluid monitoring EF, ejection fraction; NYHA, New York Heart Association; QRSd, QRS duration; CRT, cardiac resynchronization therapy; HFNeF, heart failure with a normal ejection fraction. Patient Selection Criteria for Fluid Monitoring  EF ≤35%  QRSd >120 ms  NYHA Class III or IV  Worsening heart failure despite optimal medical therapy  QRSd <120 ms but otherwise eligible for CRT  Heart failure patients with preserved systolic function (HFNeF)

7. 7 Which CRT Patients are Eligible for Hemodynamic Monitoring?  All CRT patients are, provided that: The data are valid* The patient will be recognized The device will be interrogated The information will be interpreted The results will be applied CRT, cardiac resynchromization therapy. Circulation. 2005;112:841-848.

8. HF and EP Integration Step 1

9. 9 Approaches to the CHF Patient CHF, congestive heart failure; EP-device, electrophysiology device. CHF Patient EP-device implant EP-device follow-up Clinical CHF follow-up CHF Patient EP-device implant CHF clinic Device diagnostics TRADITIONAL NEW

10. 10 Collaboration is KEY!

11. 11 Collaboration: HF/EP Connection  Patient selection –Which patient, which device to use, and when to implant?  Evaluate nonresponders and lost responders –Noncardiac, cardiac, or device related issues –Interdisciplinary: MDs, NPs, pacer, echo techs  Device optimization  Review diagnostics –Heart failure –EP-related HF, heart failure; EP, electrophysiology.

12. Device Diagnostics Step 2: Recognize the Device Download the Data

13. 13 OptiVol Fluid Trends 3. OptiVol Fluid Index: Accumulation of the difference between the Daily and Reference Impedance 4. OptiVol Threshold 2. Reference Impedance adapts slowly to daily impedance changes 1. Daily Impedance is the average of each day’s multiple impedance measurements

14. 14 Download the Data  Programmer  Cardiosight  CareLink

15. 15 Access to Trend Data: Programmer Medtronic Programmer – Model 2090 Print trends to a full-page printer to view temporally aligned trends To access data… Heart Failure Management Report with OptiVol Fluid Trends

16. 16 CardioSight ™ Service Powered by the Medtronic CareLink Network Under a clinician’s instruction at the clinic, the patient places the mouse-like antenna of the device reader over his implanted device. Data is transferred to the reader The reader transfers device data to a secure server via a standard phone line. The server then generates a Heart Failure Management Report The report is sent to the clinician via fax The clinician reviews the cardiac trends, including OptiVol fluid trends, to help assess the patient’s status

17. 17 Insight Into Patient Status AT/AF V rate during AF Patient Activity Resting Night HR HR Variability % Pacing OptiVol Fluid Trends Cardiac Compass Trends

18. 18 CardioSight Service Overview  CardioSight offers insight to enhance heart failure management –Direct access during office visits –No need to rely on the EP to access device-derived information –Better patient management—assists collaboration with EP by promoting a common language when looking at device information –Read-only access with no ability to reprogram the device –Simple, one-touch operation  CardioSight is simple to use and fits into clinic workflow HF, heart failure.

19. 19 The data is stored on a Secure Network Server that ensures confidentiality 2 Patients use the Patient Monitor to transmit device data via a standard phone line, as directed by the clinic 1 Clinic staff access patient data from the password- protected Clinician Web Site with any Internet-enabled laptop or PC 3 Medtronic CareLink ® Network

20. 20 CareLink Cardiac Compass Report

21. 21 Heart Failure Management Reports Standard90-Day Zoom

22. 22 CardioSight or CareLink CareLink  Cost: $30 per patient per quarter, unlimited use  “Billable”  Download over phone from home  Weekly impedance trends (ability to “zoom”)  Heart failure management report & Cardiac Compass  No OptiVol threshold line CardioSight  Cost: $500 one-time investment (January ‘07 annual cost $125 for reader)  Not yet “billable”  Interrogate in office  Daily impedance averages  Heart failure management report

23. 23 Organized Approach to Using Data Clinically  Arrhythmias/therapies  Thresholds/battery  Heart rates/rate response  Patient activity  Heart rate variability  % Pacing  Volume indicators Beware: Device Information Overload!

24. 24 The Alert Option  “Home Alone” option  Requires appropriate infrastructure to manage information  Utilize Carelink requires UP/HF coordination

25. 25 70 y.o. female, ICM, EF ~.1 December 27, 2006  Patient seen in CHF clinic  Noted positive Optivol  No symptoms or exam findings February 7, 2006  Patient seen in CHF clinic  No symptoms or exam findings January 29, 2006  BNP 63 January 27, 2006  Admission severe back pain  New diagnosis of compression fx  Hyponatremia Case Study

26. Analyze the Data Step 3

27. 27 How Often Do You Interrogate the Device?  Every visit: –These patients are marginally compensated –CardioSight is easy and safe to use: ancillary personnel –Quick: less than 10-minute turnaround –Free –Encourages familiarity with the device –HF signs and symptoms are unreliable  Consider it a “vital sign”

28. 28 Analyze the Data: Avoiding Pitfalls  Know the patient  Look at the “raw” impedance data  Review the entire HF report –rhythm –% A and V pacing –patient activity –heart rate variability  Hematoma, pneumonia, pocket revisions and baseline dehydration may cause “false positives”  Vascular congestion during implant and stabilization period may cause “false negatives”

29. 29 Common Misconception Indicates Severity Indicates an Event Ignore Indicates Severity

30. 30 May 23, 2005  Patient seen in CHF clinic.  Lasix adjusted  Creatinine level 1.9  BNP 467 May 20, 2005  Routine FU in device clinic  Positive Optivol threshold reported  Afib underlying rhythm. April 26, 2005  Patient seen in CHF clinic  Lasix dosage decreased  100% CRT pacing  Creatinine level 2.7  BNP 490 85 y.o. man, ICM (EF.3) Case Study

31. 31 66 y.o. male, NICM (EF.25) March 25, 2005  Readmitted with CHF/Fever/↑WBC  Complaints pounding across chest  LV lead in subclavian  CRT Pacing Therapy programmed “Off” March 27, 2005  Patient intubated (PEEP 5-8)  Patient extubated 3/29/05 April 04, 2005  LV Lead repositioned July 20, 2005  Patient seen in CHF clinic  Feels well. NYHA class 2. BNP 207  Diuretics decreased (?dry by exam) Case Study

32. Utilize Data Step 4

33. 33 Utilize the Data  Heart Failure Clinic –Consistent scripted approach –Familiarity with the devices –Relationship to the patients: impedance data must be interpreted in the context of the clinical findings  Don’t implant the device if you will not utilize the data

34. 34 OptiVol: Not an Easy Button

35. 70-year-old woman NICM (EF.2) False Positive April 26, 2005  CRT responder: class III  II  History of renal insufficiency  Diuretics decreased May 4, 2005  Bumex lowered again to 2 mg q d due to creatinine level May 23, 2005  Weight gain 3.5 lbs since 04.26  Positive Opitvol  Reference line triggered at 30d when patient dry  Patient activity level trending up June 28, 2005  Reference line trending down to  normalize at non dry weight NICM, nonionic contrast media. Case Study

36. 36 Utilizing Intrathoracic Impedance to Monitor Heart Failure Status  Retrospective analysis of 67 patients with CRT-D  Mean follow-up, 6.3 months  27 threshold crossings in 22 patients  18/23 (78%) correlated with worsening HF  6/8 HF hospitalizations crossed threshold  3 patients crossed prior to hospitalization (37.5%)  9 false positives (4 pocket or lead revisions, 3 reference value established while “dry”, 2 patients undetermined

37. 37 Summary  Thoracic impedance is highly sensitive to fluid changes  Thoracic impedance is helpful as a tool to manage HF patients in conjunction with other diagnostic information  Impedance data should be interpreted in the context of clinical findings  Data needs to be available to the clinician  Systems must be in place to deal with information generated by device diagnostics

38. 38 Benefits of Device Information  Patient compliance  Objective measure  Early warning of congestion/potentially prevent hospitalization  Follow response to treatment  Trend towards real time monitoring

39. 39 Predictions  Device data will become a “vital sign” during routine CHF clinic visits  CHF nurses and docs will become proficient at device interrogation and interpretation of results  Devices will become disease management tools