DECLARATION OF CONFLICT OF INTEREST

Transcription

1 DECLARATION OF CONFLICT OF INTEREST

2 Safety and Effectiveness of ICD Followup using Remote Monitoring ECOST Study (Effectiveness and Cost Of ICD follow-up Schedule with Telecardiology) Salem Kacet, Laurence Guédon-Moreau On behalf of the ECOST Study Investigators

3 Disclosure of interest Research grants(for Lille University Hospital), Advisory board, speaker fees from: - Biotronik, Boston Scientific, Medtronic, Saint Jude Medical, Sorin Group, - Bayer, Boehringer-Ingelheim Meda, Sanofi-Aventis ECOST Study was supported by grants from Biotronik SE & Co KG

4 Background There was in the last decades,an exponential expanding number of patients with ICDs, in the prevention of Sudden Cardiac Death HRS/EHRA 2008 expert consensus on the monitoring of CIEDs pointed out The potential of remote ICD follow-up to increase patient safety and convenience The need of proofs with clinical studies Remote follow-up of ICDs (TRUST) has been demonstrated to reduce the number of in-office device F.U. without increasing death, strokes and ICD-related AE requiring surgical interventions However, global cardiovascular safety of Remote follow-up should be reinforced

5 Home Monitoring system HM enables wireless daily automatic transmission of diagnostic data from the ICD to the physician by: Communication by a radiofrequency transmitter circuitry integrated in the ICD Acceptance and transfert data from the ICD to a service center using a cellular network via the Cardiomessenger Data reception by the service center and providing a cardiologic report accessible online by the physician via a secure Internet access Potential alerts to the physician of clinical or technical events Patient with Home Monitoring implant Cardiomessenger Mobile patient device Data transmission via cellular network BIOTRONIK Service Center View data via internet, , SMS Biotronik Home Monitoring

6 Primary objective of ECOST To evaluate the safety of Home Monitoring compared with standard ambulatory follow-up in ICD recipients Using as Primary End Point the occurrence of the first MAE Major Adverse Events (MAE) are defined as: All-cause mortality Major adverse cardiovascular event Device-related major adverse event Adverse Event(AE) is defined as major if: - fatal or life threatening - prompts or prolongs a hospitalization - causes major or permanent disability or injury - requires intervention to prevent permanent impairment or damage

7 Secondary objectives Evaluation of the effectiveness of Home Monitoring on - Inappropriate therapy rates and impact on hospitalization - Number of ICD charges and impact on ICD-battery longevity - Quality of life (SF-36) Cost of long-term remote ICD follow-up compared with standard in-office ICD follow-up (not available)

8 1-3 months 9 months 15 months 21 months Enrolment Implantation Discharge/Rando 27 months ECOST Study Design Designed to detect a noninferiority in the primary end point: Control Group 80% power 5% significance level 5% non-inferiority margin Sample size requirement of 400 patients Randomized controlled trial (( 1:1 to - Remote Monitoring follow-up Active Group - or In-office follow-up Mandatory follow-up (in-office visit) Enrolment period lasted from 01/2007 to 04/2008 Additional follow-up triggered by Home-Monitoring Additional follow-up triggered by Patient and/or Physician

9 Inclusion / Exclusion Criteria Inclusion criteria Indication of single or dual chamber ICD (without CRT) NYHA class I,II and III Exclusion criteria NYHA class IV Pregnant woman or woman who plan to become pregnant during the trial Patient whose medical situation is not stable Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea > 70mg/dl or creatinine >3mg/dl), liver failure, etc. Age < 18 years Patient unable to handle Home Monitoring system correctly The patient is not willing and able to comply with the protocol Change of residence expected during study Participation in another clinical study Patient unwilling to sign the consent for participation.

10 ECOST Study Sites BREST RENNES NANTES PESSAC CAEN ANGERS BORDEAUX PAU ARESSY NEUILLY TOURS LIMOGES AMIENS ORLEANS LILLE LOMME SAINT DENIS LAGNY PARIS CRETEIL ANTONY QUINCY CLERMONT FERRAND TOULOUSE MONTPELLIER DIJON SAINT ETIENNE AVIGNON METZ NANCY MARSEILLE BESANCON CALUIRE ET CUIRE LYON MULHOUSE NICE SAINT LAURENT DU VAR 433 patients were enrolled, randomised and followed for a mean of 24 ± 7 months 43 French centers Enrolment period: from 01/2007 to 04/2008 Private 187 Patients Public 46% 219 Patients 54% ACTIVE Group 221 Patients 51% CONTROL Group 212 Patients 49% PERPIGNAN

11 Baseline Characteristics of the population Non significant difference ACTIVE CONTROL Number of patients Age Gender (male) (%) LVEF (%) NYHA (%) I / II / III 27 / 63 / 6 25 / 61 / 12 History of SVT (%) Coronary Artery Desease/No CAD (%) 65 / / 33 Primary prevention (%) Dual chamber implants (%) First implantation (%)

12 Patients with at least one MAE* Primary End Point: Safety Patients with at least one MAE (NS) 38.5% (n=85) 41.5% (n=88) Non inferior safety of RM follow-up compared with in-office visit Active (n = 221) Control (n = 212) * MAE = Major Adverse Event

13 MAE-free survival (%) Primary End Point:safety Cumulative Survival free of MAE 100 Log Rang Test: p = Hazard Ratio : 0.91 (95%CI ) p<0.05 (non-inferiority) ACTIVE Group CONTROL Group Number at risk ACTIVE Grp CONTROL Grp Kaplan-Meier Method Months of Follow-up

14 Primary End Point by Component Death occurred in 20 (9.0%) patients in the active group and 20 (9.4%) patients in the control group. Deaths ACTIVE (n=221) CONTROL (n=212) Stroke 1 0 Heart failure 7 8 Infarction 0 1 Arrhythmia 3 1 Non cardiac 7 8 Unknown 2 2 TOTAL ( NS ) 20 (9.0%) 20 (9.4%)

15 Primary End Point by Component Cardiovascular MAE Non significant difference ACTIVE (n=221) CONTROL (n=212) Events Patients Events Patients Ventricular arrhythmia without shock Ventricular arrhythmia with shock Electrical storm Supra ventricular arrhythmia Stroke Heart failure Acute coronary syndrom Other TOTAL (NS) 95 MAE (59 pts: 26.7%) 107 MAE (63 pts: 29.7%)

16 Primary End Point by Component Device-related MAE Non significant difference ACTIVE (n=221) CONTROL (n=212) Events Patients Events Patients Inappropriate shock - related to SVT -related to T-wave oversensing -related to lead dysfunction Lead dysfunction without shock Other TOTAL (NS) 13 MAE (12 pt: 5.4%) 17 MAE (14 pts: 6.6%)

17 Secondary End Point: Effectiveness Inappropriate Shocks (IS) Remote Monitoring associated with a 52% reduction in the number of patients with inappropriate shocks and with a 72% reduction in the risk of IS-related hospitalizations ACTIVE (n=221) CONTROL (n=212) P value Number of patients with 1 IS 11 (5.0%) 22 (10.4%) 0.03 Number of IS delivered Mean per patient ns Range [1-8] [1-87] Number of patients hospitalized

18 Total number of charged shocks Secondary End Point: Effectiveness Charged shocks p< % 499 Active Control Mean per patient: Number of patients: Range [Nb shocks]: [0-58] [0-760] Remote Monitoring associated with a 76% Remote reduction Monitoring in the risk of charged shocks reduces by 4.3 the total number of charged With a shocks significant impact on battery longevity Battery depletion over time analyzed on patients with >1 charged shocks vs % per day (p=0.02) 3 vs 11 patients < 50 % usable capacity 0 vs 3 patients in ERI

19 Total number of delivered shocks Secondary End Point: Effectiveness Delivered shocks p< % 193 Remote Monitoring associated with a 71% reduction in the risk of delivered shocks Active Control Mean per patient: Number of patients: Range [Nb shocks]: [0-33] [0-116]

20 Total score (Mean StDev) Physical Health score (Mean StDev) Mental Health score (Mean StDev) Secondary End Point: Quality of Life SF36 Non significant difference Physical health Mental health Enrolment 1-3 months 15 months 27 months Enrolment 1-3 months 15 months 27 months Total score SF-36 ACTIVE Group CONTROL Group Enrolment 1-3 months 15 months 27 months

21 Conclusions Device management of patients with ICD using Home Monitoring system with daily Remote Monitoring is safe and non inferior to conventional in-office visits in a long term follow-up (27 months ) ECOST is the first trial to show that daily Home Monitoring follow-up could reduce inappropriate shocks,charged and delivered shocks With a significant impact on battery longevity of ICDs Remote Monitoring might soon become a new gold standard of care for ICD recipients follow-up

22 Thanks to Steering Committee S. Kacet (Chairman), L. Guédon-Moreau, N. Canot Endpoint Adjudication Committee J. Clémenty, D. Lacroix, N. Sadoul Electrogram Analysis Core Laboratory L. Guédon-Moreau, X. Laroche Study Coordinator S. Fauquembergue Funding Source Biotronik SE & Co. KG Statistical Analysis Group X. Bry, A. Gannoun ECOST investigators S. Abbey, E. Aliot, W. Amara, D. Babuty, H. Bader, M. Belhameche, H. Benkemoun, J.P. Bernis, G. Bertaux, O. Bizeau, J.J. Blanc, P. Blanc, D. Bleinc, P. Bordachar, M. Boursier, S. Boveda, F. Briand, F. Brigadeau, J.P. Camous, A. Chapelet, S. Cheggour, P. Chenevez, P. Chevalier, X. Copie, P. Couderc, A. Da Costa, J.M. Davy, J.C. Deharo, N. Delarche, M. Delay, A. Duparc, J.M. Dupuis, P. Durand, N. Elbaz, D. Flammang, R. Frank, J. Graux, A. Gressard, L. Guédon-Moreau, J.S. Hermida, D. Klug, C. Kouakam, A. Kowsar, D. Lamaison, L. Larouchi, G. Lascault, A. Leenhardt, J. Levy, P. Mabo, H. Mansour, J. Mansourati, C. Marquié, C.J. Mariottini C. Moini, J.L. Pasquie, O. Paziaud, O. Piot, H. Poty, M. Salvador, P. Sbragia, P. Scanu, O. Thomas