Integration of diagnostic device information to improve patient management
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1 Integration of diagnostic device information to improve patient management Haran Burri Associate Professor Cardiology Service University Hospital of Geneva
2 Disclosures Biotronik: fellowship support, speaker honoraria, consultant fees Boston Scientific: fellowship support, speaker honoraria, consultant fees Medtronic: research grants, speaker honoraria, consultant fees Sorin: fellowship support St-Jude Medical: research grants, fellowship support
3 Lung fluid Arrhythmias HR&HRV AF Pressures VT LA PA Activity Respiration RV
4 Device diagnostics and outcome Evaluation of lung fluid Integrated diagnostics Case presentations
5 Lung fluid Pulmonary oedema fall in impedance
6 Fluid Index (W days) Impedance (W) Medtronic Optivol Physician Programmable Threshold OptiVol Fluid Index Days Daily Impedance Reference Impedance Days
7 n=33 9 patients admitted 24x First occurrence of worsening HF symptoms was 3.0 ± 2.5 days before admission. Algorithm performance: 60W.d index had - 77% sensitivity for predicting HF hosp. - early warning of 13.4± 6.2 days false / patient year Circulation 2005;112:841-8
8 Fluid Accumulation Status Trial (FAST) Prospective comparison of daily weight versus double blind intrathoracic impedance in heart failure pts. Endpoint=HF events (hospitalization, ER or urgent clinic visits n=156 ROC curves for different cutofs (nominal=arrows) Abraham WT. Congest Heart Fail. 2011; 17: 51 55
9 Number and duration of crossings predict HF hospitalization n=558 Number of crossings Days with crossings Perego GB. J Interv Card Electrophysiol 2008; 23:
10 Number and duration of crossings predict HF hospitalization n=326 Number of crossings Days with crossings Small RS. J Cardiac Fail 2009; 15:
11 Number and duration of Optivol crossings predict mortality Retrospective analysis of 21,217 pts on CareLink (analysis by Discovery link) 36% of patients had Optivol >60 Ohm.days Follow-up for 19+/-9 months Mortality assessed by social security death index Tang et al. HRS 2011 (PO 2-30)
12 Optivol false positives Subclinical lung oedema Pneumonia Pleural effusion Pericardial effusion Pocket fluid Lead dislodgement Anemia Naftilan A, et al. Heart Rhythm. 2009;6
13 501 CRT patients EHJ 2011 epub ahead of print Phase I: 30 d- 6mo post implant Double blind Endpoint: HF admission >60W.d crossing <30d before admission PPV only 4.7% Phase II (unblinded) included worsening HF status: PPV 38% Reference value MUST reflect euvolemic state!
14
15 OptiVol 2.0 Change in - Reference slope adjustment during first 100 days - Less accumulation of index in pts with higher variability - Memory of index over 30 days only - 43% OptiVol 2.0 reduces unexplained detections by 43% without impacting sensitivity. Hettrick DA et al. Improved algorithm to detect fluid accumulation via intrathoracic impedance monitoring in patients with implantable devices. Heart Rhythm, Vol 7, No. 5, May Suppl 2010: S434
16 What is the optimal Optivol threshold? 115 pts with Insync Sentry CRT-D FU 9±5 months, 45 alerts (>60W.d) in 30 pts False positive in 30/45 (66%) alerts (clinical signs/symptoms requiring change in therapy) Optimal threshold calculated at 120W.d (sens. 60%, spec. 73%) Ypenburg et al. Am J Cardiol 2007;99:
17 Device diagnostics and outcome Evaluation of lung fluid Integrated diagnostics Case presentations
18 Optivol >100Wdays 694 CRT patients J Am Coll Cardiol 2010;55: or any 2 of: Optivol >60 Wdays AF duration>6h AF with V rate>90bpm Daily activity <1h/d Night HR > 85bpm HRV <60ms % CRT pacing <90% ICD shock 30-day HF hospitalization
19 Medtronic Discovery Link Single Clinic or Multiple Clinic CareLink Enrollment Data CareLink Follow-up Data Extract, Transform & Load CareLink Warehouse SMART ANALYTICS on WEB Medtronic
20 Discovery Link analysis for CRT European sample population 70 clinics on Care Link who agreed to participate CRT patients 16% of patients are in AF 14% have <90% BiV pacing Pt ID Device ID %AF %VP PerVel ajélkajsdfjf aékljdflkjadf asdéfklalésdjf asdfjléjl Jadsfkj Adfélkj Aélj alkjfak
21 Device diagnostics and outcome Evaluation of lung fluid Integrated diagnostics Case presentations
22 Case #1 56-yr old male IHD, LVEF 27%, NYHA III, LBBB Consulta CRT-D implanted 6 months ago Care Link alert for Optivol > 60Wdays Enalapril 20mg/d, Digoxin 0.25mg/d, Metoprolol 200mg/d, Atorvastatin 10mg/d
23
24
25 90-day zoom
26 90-day zoom
27 Optivol >100Wdays or any 2 of: Optivol >60 Wdays AF duration>6h AF with V rate>90bpm Daily activity <1h/d Night HR > 85bpm HRV <60ms % CRT pacing <90% ICD shock J Am Coll Cardiol 2010;55:
28 No HF symptoms or hospitalization False Optivol alert
29 Case # 2 68-yr old female DCM, LVEF 25%, LBBB, NYHA III Insync Sentry CRT-D Routine in-office follow-up NYHA III, otherwise no new complaints
30
31
32 Optivol >100Wdays or any 2 of: Optivol >60 Wdays AF duration>6h AF with V rate>90bpm Daily activity <1h/d Night HR > 85bpm HRV <60ms % CRT pacing <90% ICD shock Optivol crossings > 2 /yr > 30d /yr J Am Coll Cardiol 2010;55:
33
34 Optivol >100Wdays or any 2 of: Optivol >60 Wdays AF duration>6h AF with V rate>90bpm Daily activity <1h/d Night HR > 85bpm HRV <60ms % CRT pacing <90% ICD shock J Am Coll Cardiol 2010;55:
35 ICD shock %VP HRV Nocturnal HR Optivol AF Activity
36 Thank you!
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