Initial Experience With Intercostal Insertion of an Extravascular ICD Lead Compatible With Existing Pulse Generators.

BACKGROUND: This study assessed safety and feasibility of a novel extravascular implantable cardioverter defibrillator (ICD) lead when inserted anteriorly through a rib space and connected to various commercially available ICD pulse generators (PGs) placed in either a left mid-axillary or left pectoral pocket. Currently available or investigational, extravascular-ICDs include a subcutaneous or subxiphoid lead connected to customized extravascular-ICD PGs. METHODS: This novel extravascular-ICD (AtaCor Medical Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs. In this nonrandomized, single-center, acute study, 36 de novo or replacement ICD (transvenous ICD) patients enrolled to receive a concomitant extravascular-ICD lead inserted through an intercostal space along the left parasternal margin. extravascular-ICD leads were connected to DF-4 compatible ICD PGs positioned in either a left mid-axillary or pectoral pocket for acute sensing and defibrillation testing. Defibrillation testing started at 30 Joules (J) and stepped up or down in 5 to 10 joule increments depending on the success and limitations of the generator used. RESULTS: Successful acute defibrillation using ≤35 J was noted in 100% of left mid-axillary PG subjects (n=27, mean 16.3±8.6 J) and 83% of left pectoral PG subjects (n=6, mean 21.0±8.4 J). Furthermore, 24 of 27 (89%) of patients tested with a left, mid-axillary intermuscular PG had successful VF conversion with defibrillation energies at least 10 J below the maximum delivered output of the device. All evaluable episodes (n=93) were automatically sensed, detected, and shocked. No serious device-related intraoperative adverse events were observed. CONCLUSIONS: This first-in-human study documented the safe and reliable placement of a novel extravascular ICD lead with effective sensing and defibrillation of induced ventricular fibrillation using commercial DF-4 ICD PGs.

Feasibility of An Entirely Extracardiac, Minimally Invasive,Temporary Pacing System.

BACKGROUND: A completely extracardiac pacing system provides the potential for clinical advantages over existing device alternatives that require intravascular, endocardial, or epicardial contact. Preliminary studies evaluating the feasibility of cardiac pacing with a lead in the anterior mediastinum, outside the pericardium and circulatory system have been completed. These studies examined (1) the anatomic access route, (2) the usability of a delivery tool to facilitate lead placement, and (3) the pacing performance of the extracardiac lead. METHODS: Feasibility evaluations included (1) a retrospective computed tomography analysis to characterize anatomic variations related to lead access, (2) accessing the anterior mediastinum in cadavers and human subjects using a custom delivery tool, and (3) acute clinical pacing performance. RESULTS: Major findings: (1) A total of 166 (95%) out of 174 patients had a viable lead access path through the fourth, fifth, or sixth intercostal space. (2) Access to the targeted implant location using a delivery tool was successful in all 5 cadavers and 3 humans without use of fluoroscopy and with an average lead delivery time of 121±52 s. No damage to the lung, pericardium, heart, or internal thoracic vessels occurred. (3) Pacing performance was tested in 6 human subjects showing a threshold voltage of 4.7 V (2.7-6.7), threshold pulse width of 1.8 ms (1.0-2.5), and an impedance of 1205 Ω (894-1786). R-wave amplitudes measured 9.6 mV (5.6-12.0). CONCLUSIONS: Results support the feasibility for this completely extracardiac pacing method in a heterogeneous patient population, using a minimally invasive, parasternal, delivery approach and with adequate sensing and thresholds suited for temporary pacing.

A new algorithm to reduce inappropriate therapy in the S-ICD system.

INTRODUCTION: The subcutaneous ICD system (S-ICD) has been shown to be a safe and effective treatment for patients at risk for sudden cardiac death. This device reliably detects ventricular tachyarrhythmias with a low incidence of inappropriate shocks for supraventricular arrhythmias. However, T-wave oversensing (TWOS) is more common with the S-ICD compared with transvenous systems. We developed a novel discrimination algorithm to reduce TWOS without compromising tachyarrhythmia discrimination. METHODS AND RESULTS: The algorithm was developed using a database of recorded episodes, including 244 appropriate therapies for ventricular arrhythmias and 133 episodes with an inappropriate detection due to TWOS, and using a computer model that simulates the S-ICD system. An independent set of data of 161 TWOS episodes, 137 ventricular and 328 supraventricular episodes, was used to validate the algorithm on actual device hardware. The S-ICD performance with the new algorithm was compared with the S-ICD without the new algorithm. Development results showed a decrease in inappropriate charge due to TWOS by 30.7 ± 18%. All ventricular arrhythmias were appropriately detected and the time to appropriate charge initiation was not increased. System validation showed that the new algorithm avoided an inappropriate charge due to TWOS by 39.8 ± 11.4%. No decrease in ventricular arrhythmia sensitivity and no significant change in supraventricular specificity were observed. CONCLUSIONS: A new algorithm that uses correlation of the existing complex to previous complexes reduced TWOS episodes by approximately 40%. The algorithm has potential for a clinically meaningful decrease in inappropriate shocks.

Development of the subcutaneous implantable cardioverter-defibrillator for reducing sudden cardiac death.

Implantable cardioverter-defibrillators (ICDs) detect ventricular arrhythmias responsible for causing sudden cardiac arrest and then deliver a high-voltage defibrillation shock to terminate the arrhythmia and restore normal cardiac function. Conventional transveneous ICD (TV-ICD) systems require one or more leads to be implanted into the heart through the venous anatomy. While TV-ICDs are well tolerated by most patients, the invasive approach can be associated with severe complications, including systemic infection, cardiac injuries, and lead failures. An entirely subcutaneous ICD (S-ICD) system was developed as a less invasive alternative to TV-ICDs without requiring leads in or on the heart. The S-ICD system provides therapy with a left lateral pulse generator and parasternal electrode configuration that is placed under the skin outside the rib cage, resulting in a much lower risk profile. Advances in defibrillation research and far-field sensing combined to enable development of the commercial S-ICD system. An investigation device exemption (IDE) clinical investigation followed, with FDA approval in September 2012. Evaluation of the long-term performance of the S-ICD system continues, with two independent postmarket registries and a prospective randomized head-to-head trial versus the transvenous ICD.

Feasibility of defibrillation and automatic arrhythmia detection using an exclusively subcutaneous defibrillator system in canines.

INTRODUCTION: This study reports the experimental process leading to development of an automatic totally subcutaneous implantable cardioverter defibrillator (SICD) system engineered for human use. METHODS AND RESULTS: Two studies were conducted to test defibrillation and detection feasibility of an SICD system located in the left chest. In the first study, 2 pockets were created in 15 canines for placement of an anterior electrode adjacent to the left edge of the sternum and a lateral electrode at the site along the axillary line between the 4th and 6th intercostal space. Stainless steel flat electrodes with active surface areas of 5, 10, 20, and 25 cm(2) or rod electrodes were subsequently positioned and the defibrillation threshold (DFT) was measured for multiple combinations. In the second study, the ability to induce, detect, and provide shock delivery in response to ventricular fibrillation (VF) using an SICD system engineered for clinical use was tested in 5 canines. One hundred and three DFT tests with 11 different dual electrode combinations were performed. All combinations terminated VF with a DFT of 35 ± 16 J (range: 9-79 J). Nineteen VF episodes were induced and recognized by the chronic SICD, leading to automatic capacitor charge and shock delivery in all cases. CONCLUSIONS: Subcutaneous defibrillation using different electrode combinations with shock energies less than 80 J terminated all induced VFs. An automatic SICD proved effective in detecting and activating shock delivery in all cases.

Development of an entirely subcutaneous implantable cardioverter-defibrillator.

The recent advent of an entirely subcutaneous implantable defibrillator (ICD) has provided a relevant contribution to the debate concerning the use of ICD therapy in patients at high risk for death. Although conventional transvenous ICDs have proven very effective during the past 23 years, they still appear to be limited by nontrivial acute and long-term complications. This study delineates some of the historical and current issues characterizing the advent of the subcutaneous ICD system in daily clinical practice. Subcutaneous ICDs have proven effective in more than 1100 patients worldwide and appear to be competitive with transvenous ICD in all clinical conditions not requiring antibradycardia, antitachycardia, or cardiac resynchronization pacing.

Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study.

BACKGROUND: The development of a totally subcutaneous implantable defibrillator (S-ICD) system requires a new approach for arrhythmia detection. To evaluate arrhythmia discrimination of one such system, the Subcutaneous versus Transvenous Arrhythmia Recognition Testing (START) study was designed as a prospective, multicenter trial comparing simulated sensing performances of the S-ICD system with single- (SC-TV) and dual-chamber transvenous (DC-TV) implantable cardioverter-defibrillator (ICD) systems. METHODS: At ICD implantation, induced ventricular and atrial arrhythmias were recorded simultaneously in transvenous (right ventricular [RV] → superior vena cava [SVC]+ Coil) and cutaneous electrode configurations. Recorded signals of ventricular (n = 46) and atrial arrhythmias (n = 50) with ventricular rates >170 bpm from 64 patients were used to compare detection performance of the S-ICD system with TV-ICD systems from 3 manufacturers. Appropriate detection of ventricular tachyarrhythmias was assessed with devices programmed in single-zone (rate ≥ 170 bpm) and dual-zone configurations (ventricular fibrillation ≥ 240 bpm; ventricular tachycardia ≥ 170 bpm). S-ICD specificity performance for supraventricular arrhythmias was compared to single- and dual-chamber devices in a dual-zone configuration. RESULTS: Appropriate detection of ventricular tachyarrhythmias for subcutaneous and TV devices in single- and dual-zone configurations was 100% and >99%, respectively. Specificity for supraventricular arrhythmias was significantly better for the S-ICD system compared to 2 of 3 TV systems, as well as the composite of TV devices (98.0%[S-ICD] vs 76.7%[SC-TV range: 64.0-92.0%] vs 68.0%[DC-TV range: 32.7-89.8%; P < 0.001]). CONCLUSION: Appropriate ventricular arrhythmia detection is excellent for all ICD systems evaluated; however, specificity of supraventricular arrhythmia discrimination by the S-ICD system is better than discrimination by 2 of 3 TV systems.