Worldwide Experience with S-ICD: Early results from the EFFORTLESS Registry

Transcription

1 Worldwide Experience with S-ICD: Early results from the EFFORTLESS Registry Results published in European Heart Journal (March 2014) Pier D. Lambiase, Craig Barr, Dominic A.M.J. Theuns, Reinoud Knops, Petr Neuzil, Jens Brock Johansen, Susanne Pedersen, Stefan Kääb, Francis Murgatroyd, Helen L. Reeve, Nathan Carter & Lucas Boersma, on behalf of the EFFORTLESS Investigators. CRM AA MAR14 1 PD Lambiase, C Barr, DAMJ Theuns, et. al., European Heart 2014 Boston Scientific Corporation or its affiliates. All rights reserved. CRM Journal AA Mar APR

2 Background International, standard of care registry to document short, mid and long-term operational and clinical outcome data on the S-ICD system 1000 patients followed for 5 years post implant Includes both retrospective and prospective patients implanted since CE mark in 2009 Centers to be included from all current commercial countries Boston Scientific Corporation or its affiliates. All rights reserved.

3 Eligibility Inclusion Criteria 18yrs at time of consent* Eligible for implantation of an S-ICD System per local clinical guidelines or currently implanted with a S-ICD System Exclusion Criteria Participation in any other investigational study that may interfere with interpretation of the study results Class I indications for permanent pacing Pace-terminable VT Previously implanted unipolar pacemakers *A subset of countries implemented a protocol that allows patients under the age of Boston Scientific Corporation or its affiliates. All rights reserved.

4 Interim Results Published in European Heart Journal in early patients enrolled between Feb 2011 and April 2013 at 29 sites from seven different countries 232 included in QOL sub-study (not yet reported) Boston Scientific Corporation or its affiliates. All rights reserved.

6 Baseline Characteristics Demographic Value Category Age (years) 49 ± 18 (range 9 88) Male, % 72% EFFORTLESS Registry n= 472 patients Represents a younger population than typical TV-ICD studies and registries NCDR ICD Registry n=486,025 patients Primary and Secondary Prevention mix is typical of the current EU TV-ICD implants Boston Scientific Corporation or its affiliates. All rights reserved.

7 Baseline Characteristics Broad Spectrum of Clinical Indications * * * Significant proportions of historically more difficult to treat indications (non-ischemic, congenital and inherited channelopathies) representing >50% of total population Boston Scientific Corporation or its affiliates. All rights reserved.

8 Baseline Characteristics Attribute Statistic/Category N % Congestive Heart Failure Comorbidities Class I Class II Class III History Hypertension Diabetes Atrial Fibrillation Kidney disease 39 9 Cardiac Surgical History Concomitant pacemaker Previous TV-ICD LVEF, % 42 ± 19 QRS interval, ms 107 ± TV-ICD Explant patients were also studied in the registry Co-morbidities present typical of the current TV-ICD patient population Boston Scientific Corporation or its affiliates. All rights reserved.

9 Implant Procedure and Follow-up Attribute Statistic/Category N % Implant Procedure Follow-up data Patients implanted General anesthesia 63 Medical imaging 13 Skin-to-skin time, min* 69 ± 27 Min max, days Median, days 498 Mean, days 558 Patients with 1-yr FU Patients with 2-yr FU Patients with 3-yr FU Longest patient follow-up is >3.5 years * No distinction was made between procedure times that were solely for implant of the S-ICD versus those that included additional procedures Boston Scientific Corporation or its affiliates. All rights reserved.

10 Patient Status Attribute Statistic/Category N % Mortality Explants Total Deaths 9 2 Peri-procedural deaths 0 0 Pump/Renal Failure Lack of Documentation Arrhythmic* Total Infection-related Inappropriate sensing & shocks** Elective TV-ICD update (recurrent VT) Failure to convert Comfort Erosion Heart Transplant * Patient (not a candidate for TV-ICD) with Loeffler s syndrome required steroid therapy which may have led to elevated DFT None of the deaths (n = 9) have been reported to be related to the S-ICD system or implant procedure Boston Scientific Corporation or its affiliates. All rights reserved.

11 Complication-Free Rate 94% Complication Free at 360 days 97% Peri-procedural complication free rate 94% 1yr complication free rate Boston Scientific Corporation or its affiliates. All rights reserved.

12 Infections All Suspected & Confirmed Infections 18 patients (3.9%) Confirmed Infection* 11 patients (2.4%) Explants 10 patients (2.2%) No systemic blood infections or endocarditis No reports of infection in patients with previous TV-ICDs (explanted due to infection) Permanent Explants 8 patients (1.8%) S-ICD Re-Implantation 2 patients (0.4%) * 2 infections were due to concomitant TV leads Boston Scientific Corporation or its affiliates. All rights reserved.

13 Implant Conversion Testing Successful conversion efficacy at implant defined as at least one successful conversion of an induced ventricular arrhythmia at 80J Patient data N % Complete data for evaluation 393 Successful Conversion Repositioning required for initial failure Successful at 65J Implant Conversion Efficacy was 99.7% Boston Scientific Corporation or its affiliates. All rights reserved.

14 Spontaneous Conversion Efficacy VT/VF episodes (Pts) Classification N (Pts) Storm 40 (4) Sustained VT/VF 91 (33) Discrete 51 (29) Classification Total (Pts) TERMINATION (%) Discrete VT/VF Episodes Storm Episodes 1 st S-ICD Shock Conversion) Conversion by Shocks 1-5 Conversion prior to end of episode 51 (29) 45 (88%) 49 (96%) 51 (100%) 40 (4) (6 Storm Events) 5 (83%)* * Patient with Loeffler s syndrome requiring steroid therapy which may have lead to elevated DFT All discrete episodes were successfully converted with 80J shock or spontaneously terminated (100% clinical efficacy) Boston Scientific Corporation or its affiliates. All rights reserved.

15 Inappropriate Therapy: Incidence 32 patients received 73 inappropriate shocks on average FU of 18 months, resulting in an inappropriate therapy rate of 7% at 360 days. IAS & Programming Reasons for IAS P = % of patients were programmed to dual-zone which reduced the inappropriate therapy rate to 6.4% Only one inappropriate therapy has been recorded for AF/SVT within the programmed conditional zone in all S-ICD System clinical evaluations 72% of patients were inappropriate therapy-free after initial interventions (reprogramming, exercise tests, medication changes) Boston Scientific Corporation or its affiliates. All rights reserved.

16 Time to therapy Induced Spontaneous 15.1 ± 3.7 sec with range of 7 to 37 seconds TTT generally shorter with induction due to only 65 J charge and removal of one counter to allow faster therapy delivery 17.5 ± 4.4 sec with range of 6 to 29 seconds Therapy withheld in 13% of patients and 46% of stored episodes due to longer time to therapy No clinical events (i.e. syncope) were reported for any of the spontaneous episodes Boston Scientific Corporation or its affiliates. All rights reserved.

18 S-ICD System from Boston Scientific CRM Indications for Use The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing. Contraindications Unipolar pacemakers are contraindicated for use with the S-ICD System. Warnings and Cautions The S-ICD System contains sterile products for single use only. Do not resterilize. Handle the components of the SICD System with care at all times and maintain proper sterile technique. All Cameron Health implantable components are designed for use with the Cameron Health S-ICD System only. Connection of any S-ICD System components to any other ICD system will result in failure to deliver lifesaving defibrillation therapy. General External defibrillation equipment should be available for immediate use during the implantation procedure and follow-up. Placing a magnet over the SQ-RX Pulse Generator suspends arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia detection and therapy response. Battery depletion will eventually cause the SQ-RX Pulse Generator to stop functioning. Defibrillation and excessive numbers of charging cycles shorten the battery longevity. The S-ICD System has not been evaluated for pediatric use. The S-ICD System does not provide long-term bradycardia pacing, Cardiac Resynchronization Therapy (CRT) or Anti-Tachycardia Pacing (ATP). Potential Adverse Events related to implantation of the S-ICD System may include, but are not limited to, the following: Acceleration/induction of atrial or ventricular arrhythmia; Adverse reaction to induction testing; Allergic/adverse reaction to system or medication; Bleeding; Conductor fracture; Cyst formation; Death; Delayed therapy delivery; Discomfort or prolonged healing of incision; Electrode deformation and/or breakage; Electrode insulation failure; Erosion/extrusion; Failure to deliver therapy; Fever; Hematoma; Hemothorax; Improper electrode connection to the device; Inability to communicate with the device; Inability to defibrillate or pace; Inappropriate post-shock pacing; Inappropriate shock delivery; Infection; Keloid formation; Migration or dislodgement; Muscle stimulation; Nerve damage; Pneumothorax; Post-shock/post-pace discomfort; Premature battery depletion; Random component failures; Stroke; Subcutaneous emphysema; Surgical revision or replacement of the system; Syncope; Tissue redness, irritation, numbness or necrosis. S-ICD, SQ-RX and Q-TRAK are registered trademarks of Cameron Health, Inc. Q-TECH, Q-GUIDE and INSIGHT are trademarks of Cameron Health, Inc. Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only. (Rev. C Information for the use in countries with applicable Health Authority product registrations Boston Scientific Corporation or its affiliates. All rights reserved.