Real World Experience with the Subcutaneous ICD in the United States: The S-ICD Post-Market Approval Study
The subcutaneous ICD (S-ICD) was developed to reduce short and long term complications associated with transvenous ICD leads. Early studies in the US and Europe were enriched with younger patients with less left ventricular systolic dysfunction and fewer comorbidities than transvenous ICD subjects, making comparisons between systems difficult. Following FDA approval in 2012 a prospective registry of the S-ICD was undertaken, which is the largest study of this device to date.
Pre-implantation patients were enrolled if they met criteria for ICD, passed at least one vector in ECG screening and had a life expectancy > 1 year. Implant technique, programming and conversion testing were performed using the standard of care of investigational centers. Results were analyzed with descriptive statistics, Kaplan Meier time to event analysis, and multivariate logistic regression.
Following FDA approval of the S-ICD, a prospective study was initiated. The cohort and short term results will be presented.
Michael R. Gold, MD, PHD, FHRS
Medical University of South Carolina
As Presented at Heart Rhythm 2017:
Late-Breaking Clinical Trials Session
C-LBCT01. Late-Breaking Clinical Trials I
Thursday, May 11, 2017
Target Audience -
This enduring product supported in part by Boston Scientific Corporation.
Product Support Summary - Boston Scientific Corporation S-ICD
EMBLEM™ MRI S-ICD System
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.
Unipolar pacing and impedance-based features are contraindicated for use with the S-ICD System.
Read the manual thoroughly before using the S-ICD System to avoid damage to the pulse generator and/or subcutaneous electrode. Such damage can result in patient injury or death. For single patient use only.Do not reuse, reprocess, or resterilize. All Boston Scientific S-ICD implantable components are designed for use with the Boston Scientific S-ICD System only. Connection of any S-ICD System components to a non-compatible component will result in failure to deliver life-saving defibrillation therapy. Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow-up testing.Using multiple pulse generators could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery. Test each system individually and in combination to help prevent undesirable interactions. Concomitant use of the S-ICD System and implanted electromechanical devices (for example a ventricular assist device, VAD; or implantable insulin pump or drug pump) can result in interactions that could compromise the function of the S-ICD, the co-implanted device, or both. Electromagnetic (EMI) or therapy delivery from the co-implanted device can interfere with S-ICD sensing and/or rate assessment, resulting in inappropriate therapy or failure to deliver therapy when needed. In addition, a shock from the S-ICD pulse generator could damage the co-implanted device and compromise it’s functionality. To help prevent undesirable interactions, test the S-ICD system when used in combination with the co-implanted device, and consider the potential effect of a shock on the co-implanted device. Handle the components of the S-ICD System with care at all times and maintain proper sterile technique. Do not modify, cut, kink, crush, stretch or otherwise damage any component of the S-ICD System.Use caution handling the subcutaneous electrode connector. Do not directly contact the connector with any surgical instruments such as forceps, hemostats, or clamps. Use appropriate anchoring techniques as described in the implant procedure to prevent S-ICD System dislodgement and/or migration. Do not implant in MRI site Zone III. Use caution when placing a magnet over the S-ICD pulse generator because it suspends arrhythmia detection and therapy response. In patients with a deep implant placement (greater distance between the magnet and the pulse generator) magnet application may fail to elicit the magnet response. Do not expose a patient with an implanted S-ICD System to diathermy. EMBLEM S-ICD devices are considered MR Conditional. Unless all MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system. The Programmer is MR Unsafe and must remain outside the MRI site Zone III. During MRI Protection Mode the Tachycardia therapy is suspended. MRI scanning after ERI status has been reach may lead to premature batter depletion, a shortened device replacement window, or sudden loss of therapy. The Beeper may no longer be usable following an MRI scan. It is strongly recommended that patients are followed on LATITUDE NXT after an MRI scan if they are not already. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. The pulse generator may be more susceptible to low frequency electromagnetic interference at induced signals greater than 80 uV. The S-ICD System has not been evaluated for pediatric use.
For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal and supplemental precautionary information.
Advise patients to avoid sources of EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.
Potential Adverse Events
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/seroma, 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/nerve 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.
Patients who receive an S-ICD System may develop psychological disorders that include, but are not limited to, the following: depression/anxiety, fear of device malfunction, fear of shocks, phantom shocks.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for France.
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