ESC Paris Remote monitoring of cardiac rhythm devices: present and future HEART FAILURE

Transcription

1 ESC Paris Remote monitoring of cardiac rhythm devices: present and future HEART FAILURE Frieder Braunschweig MD PhD FESC Associate Professor of Cardiology Karolinska University Hospital Stockholm, Sweden

2 Disclosure Consultant: Research funding: Biotronic, Boston Scientific Medtronic Speakers honoraria: Medtronic, Biotronic, Sorin

3 Increase of patients with ICD Worldwide ICD/CRT-D implants (estim # per year) First Human Implant FDA Approval Dual- Chamber ICDs Transvenous Leads Biphasic Waveform MADIT AVID CASH CIDS CRT-D MADIT-II MUSTT SCD HeFT COMPANION MADIT-CRT

4 Home monitoring of devices Pacemaker Biotronic Home Monitoring Defibrillator Guidant Latitude Medtronic CareLink Dataserver Service-center Physician-/ Nurse- Access St Jude Medical House Call

5 Continuum of chronic HF HF patient monitored over 1 year Mean pulmonary artery pressure (mmhg) Hospitalization Hospitalization FU visit FU visit

6 Device based monitoring features

7 Monitoring physical activity n=11 p<0.001 n=37 p<0.001 n=8 n=56 Braunschweig et al. Am J Cardiol 2005

8 Monitoring heart rate variability n=288 CRT-pts Adamson et al. Circulation 2004;110:

9 Risk score Singh JP et al. Europace (2009) 11,

10 Monitoring minute ventilation, workload Auricchio A et al. Eur J Heart Fail 2010;12:

11 Monitoring intrathoracic impedance Dryer lungs Wetter lungs Impedance Impedance

12 Impedance (Ω) Yu CM et al, Circulation 2005,112; Intrathoracic impedance: MIDHeFT Impedance reduction prior to admissions d -3 d 0 Impedance decrease Days Symptoms Onset -12.3% Admission Decline in impedance preceded symptoms onset by 15.3 days (p<0.001)

13 Monitoring impedance and body weight 36 HF patients InSync Sentry CRT-D (Impedance) Telemonitoring scales (Zenicor) months follow-up Gudmundsson et al, HEART FAILURE 2011 (p392)

14 Monitoring impedance and body weight 75 Major HF events 82 Minor HF events n=14 n=17 Impedance (Ohm) Impedance (Ohm) Days before event Days before event Major HF events Minor HF events Body weight (kg) Body weight (kg) Days before event Days before event Gudmundsson et al, Heart Failurre 2011

15 Monitoring impedance and RV pressures 16 HF patients InSync Sentry CRT-D (Impedance) Implantable hemodynamic monitor (PA diast pressure) months follow-up Vanderheyden, Braunschweig et al, Circulation Heart Failure 2010, 3:

16 Monitoring impedance and RV pressures Reference month 30 d before event 14 d before event 1 d before event epad change (mmhg) Major* Major* Minor* Major p<0.05 Minor No HF * * Minor Impedance change (Ohm) Minor Major Minor Major No HF Minor p<0.05 Major * * -7 *: p<0.05 vs reference month

17 OptiVol alert: patient example Braunschweig F et al, Eur J Heart Fail Sep;10(9):907-16

18 False positive fluid alerts Possible reasons for Optivol alert: Overt decompensation Impending decompensation, minor symptoms Impending decompensation, no symptoms Pocket edema (implantation, revision etc) Operation (heart surgery, lead revision etc) Pneumonia, bronchitis Pleural/pericardial effusion Too late! Meeting monitoring objective Clinically meaningful False alert

19 OptiVol alert: Sense-HF SENSE-HF: Prospective, multi-centre, n= 501 Phase I: 6M, double blinded, 58 HF hospitalizations HF hospitalizations after implant (blinded phase) OptiVol sensitivity increased during blinded phase (P = 0.016) Conraads V M et al. Eur Heart J 2011

20 Integrated diagnostics: PARTNERS-HF n=694 CRT-D FU 11.7 M n=141 HF hosp in 90 pts Whellan D et al JACC 2010;55:

21 Monitoring of pulmonary artery pressure Champion study Swan Balloon Target Implant Site Abraham WT, Adamson PB et al, Lancet 2011; 377:

22 Monitoring of pulmonary artery pressure Champion study Abraham WT, Adamson PB et al, Lancet 2011; 377:

23 Avalanche of diagnostic information?

24 Risk stratification: smart algorithms Multi sensor approach Automatic risk assessment Green / yellow / red risk markers Normal Intensified surveillance Patient contact, intervention

25 Components of device based HF monitoring Sensor Device features Data transmission Medtronic CareLink Data interpretation Clinical expert? Implementation into daily practice Computer? Adjusting work-flow Monitors Biotronic Home Monitoring Call center? Reimbursement Patient alert? Collaboration: Pressure sensors Boston Latitude Pacing Body weight St Jude Medical House Call Heart failure Blood pressure

26 Yesterday's patient care?

27 Tomorrow's heart failure clinic?

28 Connecting the Circle from Home to Heart-Failure Disease Management Desai AS and Stevenson LW, NEJM 2010; 24: 2364

29 Future outlook HOMEOSTASIS study Ritzema et al Circulation. 2010;121:

30 Future outlook Multivariable diagnostic approach Integrating information from pressure sensors Collaboration pacing /heart failure Putting the patient into the loop Clinical outcome trials

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32 Routine Follow-up OptiVol Alert PATIENT Calls in / gets called (CareLink) NURSE First evaluation on the phone Retrieves Carelink data (if available) Informs physician (if necessary) PHYSICIAN (remotely or in office) Alternative causes of impedance decrease? Pocked fluid? Pneumonia? Bronchitis? Pericardial effusion? Thoracotomi? Atrial fibrillation? Consider: Adjusting rhythm/rate control Adjusting anticoagulation Early cardioversion Reviews patient history (and status) Reviews OptiVol and other device data Congestion Consider: Education on diet, medication Adjusting treatment (if needed) Adding diuretics (eg for 3-7 days) Physician (HF nurse) Re-evaluate patient after 7 days No congestion Wait and see Routine Follow-up Patient improved Impedance normalized Patient unchanged or worsened Impedance still low

33 VT/VF per day V-rate during VT/VF Motoring of integrated diagnostics upon - device FU visits - HF clinic visits - routine remote FU - upon alerts - upon patient symptoms AT/AF V rate during AF % Pacing/day Average V. rate Patient Activity HR Variability Fluid index Intrathoracic impedance

34 Should we use device alerts? OptiVol fluid alert: In patients with high risk for decompensation In patients sensible for small volume changes Remote interaction (CareLink)! AF-alert: In patients with no previous AF In patients known to be hemod. intolerable to AF

35 CHAMPION study Monitoring of pulmonary artery pressure Major Eligibility Criteria NYHA Class III, optimal/stable drugs and devices Hospitalized for HF within past 12 months BMI 35*, PA branch diameter sized 7-15 mm No history of recurrent (> 1) PE or DVT GFR 25 ml/min No coagulation disorder Abraham WT, Adamson PB et al, Lancet 2011; 377:

36 CHAMPION study 550 Pts Daily Readings Treatment 270 Pts Routine Management + Hemodynamics Control 280 Pts Routine Management Primary Endpoint: HF Hospitalizations at 6 Months Safety endpoints Multiple Secondary Clinical Endpoints Abraham WT, Adamson PB et al, Lancet 2011; 377:

37 08:30-10:00 Budapest - Zone E REMOTE MONITORING OF CARDIAC RYTHM DEVICES: PRESENT AND FUTURE Symposium Chairperson(s): D.L. Scher (Harrisburg, US); B. Gorenek (Eskiseh TR) 08:30 Pacemakers and implantable cardioverter-defibrillators 3780 P. Mabo (Rennes, FR) 08:52 Heart failure F. Braunschweig (Stockholm, SE) 09:15 Patient management and legal issues G. Boriani (Bologna, IT) 09:37 Data exchange between remote monitoring databases a local electronic patient record system E.T. van der Velde (Leiden, NL) 08:30-10:00

38 Who should monitor? Collaboration Collaboration - Education - Organization

39 Fluid management in heart failure Decompensated HF does not come over night RV Systolic pressure (mmhg) Hospitalization for decompensated HF (days)

40 TRUST study: results Home Monitoring - is as safe as conventional in-office FU - reduces in-office FU visits by 45% Median time to evaluation of arrhythmia events VT 1 VF 1 AF Days (Home Monitoring vs conventional in-office FU) Varma N et al, Circulation Jul 27;122(4):325-32

41 HH hospitalization in device patients MADIT II Hospitalization for HF CARE-HF II Survival free from CV event (%) Control ICD COMPANION Death from or hospitalization for HF MADIT-CRT Survival free from HF

42 Heart failure monitoring Which information can be monitored? What is the potential clinical value? Are device alerts useful?

43 Monitoring heart rate variability p<0.001 p<0.05 n=56 Braunschweig et al. Am J Cardiol 2005; 95 (9):1104-7

44 Implantable hemodynamic sensors Remon Impressure (Boston Scientific) PA pressure sensor (CardioMems)

45 Implantable hemodynamic sensors Implantable Savacor HeartPOD (St Jude Medical) Chronicle implantable hemodynamic monitor (Medtronic)

46 HF device patient network EP physician HF physician Pacemaker technician Device function Arrhythmia management Remote In office follow Follow-up follow - up HF CRT device Patient patient Implantable monitoring Optimal medication HF nurse/ coordinator Cardiac imaging Quality of life Family practicioner Functional assessment Patient education Internist Imaging specialist

47 HF-cl>inic Pace-clinic Echo FU Referring for implantation CRT implantation Adjusting medication FU Deterioration FU Device optimization Deterioration Perm AFib FU Treatment? Monitoring features FU His ablation Echo Synkope FU Arrhythmia? Monitoring features FU Monitoring features FU

48 HF-management unit FU FU FU Diagnostic evaluation Clinical Echo CPX Medical treatment Drugs Exercise Psychosocial Device follow-up CRT ICD Monitoring Telemonitoring