Use Of Subcutaneous Implantable Cardioverter Defibrillator Research Articles

The Subcutaneous Implantable Cardioverter-defibrillator: New Features and Implant Techniques and Future Developments.

The use of subcutaneous implantable cardioverter-defibrillators (S-ICDs) has increased over time. Device-based algorithms have been developed to reduce inappropriate shocks. New implant techniques have been developed including the two-incision technique and the placement of the generator submuscularly. More patients are being implanted without general anesthesia. This review summarizes the newest S-ICD features, surgical implantation methods, and device-related safety and efficacy findings.

Use and outcomes of subcutaneous implantable cardioverter-defibrillator (ICD) after transvenous ICD extraction: An analysis of current clinical practice and a comparison with transvenous ICD reimplantation

The subcutaneous implantable cardioverter-defibrillator (S-ICD) does not require the insertion of any leads into the cardiovascular system. The aims of the study were to describe current practice and to measure outcomes associated with S-ICD or standard single-chamber transvenous ICD (TV-ICD) use after TV-ICD explantation. We analyzed all consecutive patients who underwent transvenous extraction of an ICD and subsequent implantation of an S-ICD or a single-chamber TV-ICD at 12 Italian centers from 2011 to2017. A total of 229 patients were extracted and subsequently reimplanted with an S-ICD (90; 39%) or a single-chamber TV-ICD (139; 61%). S-ICD implantation increased from 9% in 2011 to 85% in 2017 (P< .001). Patients reimplanted with an S-ICD were younger (53 ± 13 years vs 60 ± 18 years; P = .011) and more frequently had undergone extraction owing to infection (73% vs 52%; P<.001). The rates of complications at follow-up were comparable between groups (hazard ratio 0.97; 95% confidence interval 0.49-1.92; P = .940). No lead failures, systemic infections, or system-related deaths occurred in the S-ICD group. In the TV-ICD group, 1 lead fracture occurred and 2 systemic infections were reported, resulting in death in 1 case. In the S-ICD group, the rate of complications was lower when the generator was positioned in a sub- or intermuscular pocket (hazard ratio 0.21; 95% confidence interval 0.05-0.87; P = .048). Our results show an increasing use of S-ICD over the years in patients undergoing TV-ICD explantation. An S-ICD is preferably adopted in young patients, mostly in the case of infection. The complication rate was comparable between groups and decreased when a sub- or intermuscular S-ICD generator position was adopted.

Subcutaneous implantable cardioverter defibrillator implantation: An analysis of Italian clinical practice and its evolution

BackgroundThe subcutaneous implantable cardioverter defibrillator (S-ICD) is a relatively novel alternative to the transvenous ICD for the treatment of life-threatening ventricular arrhythmias, and is currently used in the clinical practice of several centers. The aim of this analysis was to describe current Italian practice regarding S-ICD implantation and its evolution over the years. MethodsWe analyzed 607 consecutive patients (78% male, 48 ± 16 years) who underwent S-ICD implantation in 39 Italian centers from 2013 to 2017. ResultsStructural cardiomyopathy was present in 78% of patients and 30% of patients received their device for secondary prevention. The proportion of patients with dilated cardiomyopathy and with left ventricular ejection fraction ≤35% increased from ≤2014 to 2017 (from 38% to 58%, from 33% to 53%, respectively; both p < 0.05). Almost all procedures (97%) were performed in electrophysiology laboratories. Over the last 4 years, the 2-incision implantation technique has been widely adopted, with sub- or inter-muscular positioning of the generator, under local anesthesia or deep sedation (≤2014 versus 2017: all p < 0.001). Defibrillation testing was performed in 81% of patients. Shock energy of ≤65 J was successful in 93.9% of patients and the overall cardioversion success rate at ≤80 J was 99.8%. ConclusionsOur analysis confirmed that the S-ICD continues to be preferentially used in specific patients (younger, less frequently with dilated cardiomyopathy and low ejection fraction.). Nonetheless, we noted a trend toward the wider use of S-ICD in patients with dilated cardiomyopathy and systolic dysfunction over the years. Novel approaches have been adopted while the acute efficacy of the system has remained stably high.

Streamlined Surgical Draping Reduces Subcutaneous Implantable Cardioverter-defibrillator Implant Procedure Preparation Time.

The subcutaneous implantable cardioverter-defibrillator (S-ICD) is a proven alternative to transvenous implantable cardioverter-defibrillator systems. One critique of S-ICD use, however, has been the time required for implantation. Here, we discuss the use of an alternative surgical draping technique to reduce preparation time for device implantation.

Polish single-centre follow-up of subcutaneous implantable cardioverter-defibrillator (S-ICD) systems implanted for the prevention of sudden cardiac death.

Subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective and modern tool used to protect patients at risk of sudden cardiac death (SCD) from potentially life-threatening ventricular arrhythmias. The first S-ICD systems were implanted in Poland in 2014, but since that time the national experience with that therapy has been limited. Our analysis summarises the single-centre experience at the Department of Cardiology and Electrotherapy of the Medical University of Gdansk with the use of S-ICD from the year 2014 to 2017. The S-ICD therapy was used in 12 patients (five male, seven female, mean age 57.2 ± 12.5 years), in eight of them for the secondary prevention of SCD. No surgical complications of implantation procedures were observed during the perioperative hospitalisation nor during follow-up. During the mean follow-up of 14 ± 13 months we observed the appropriate function of the systems and a ventricular fibrillation episode successfully terminated by the device in one patient, two cases of S-ICD sensing problems (one of which led to inadequate intervention of the device), and an episode of atrial fibrillation also leading to inadequate intervention in another patient. S-ICD, being an effective and safe method used to treat patients at risk of SCD, may be safely and successfully introduced into clinical practice in centres new to that field. The number of complications during the initial experience and introduction of that method may be kept low if the operating team is experienced enough in cardiac electrotherapy.

Acute and Long-term Results After Contemporary Subcutaneous Implantable Cardioverter-defibrillator Implantation: A Single-center Experience

Introduction and objectivesThe subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as an alternative to the transvenous defibrillator. The incidence of complications is similar, with inappropriate shocks (IS) being more frequent than those occurring with contemporary programming of transvenous defibrillators. Several improvements have been implemented after the S-ICD was approved for use in Europe in 2009. This study reports the results of S-ICD use in a single center, whose experience began late, at the end of 2013. MethodsProspective observational study including consecutive patients with defibrillator indication and no indication for either permanent pacing or cardiac resynchronization who underwent S-ICD implantation. Implant data and long-term follow-up were analyzed. ResultsAn S-ICD was implanted in 50 patients who were deemed suitable after electrocardiographic screening. The mean age was 46.9±15 (range, 15-78) years and 72% were male. Thirty eight percent had left ventricular ejection fraction ≤ 35%. The most frequent heart disease was ischemic heart disease (34%), followed by hypertrophic cardiomyopathy (18%). The intermuscular technique was used, with 3 incisions in 10% and 2 incisions in the remaining 90%. Ventricular fibrillation was induced in 49 patients, with 100% effectiveness in their conversion. After a mean follow-up of 18.1 (range, 2.3-44.8) months, there were no late complications requiring surgical revision, the rate of IS was 0%, and 1 patient (2%) experienced appropriate shocks. ConclusionsImprovements in technology, implant technique and device programming, along with appropriate patient selection, have led to outstanding acute and long-term results, especially regarding the absence of both IS and complications requiring surgical revision.

Resultados agudos y a largo plazo tras implante contemporáneo de desfibrilador subcutáneo: experiencia en un centro

Introduction and objectivesThe subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as an alternative to the transvenous defibrillator. The incidence of complications is similar, with inappropriate shocks (IS) being more frequent than those occurring with contemporary programming of transvenous defibrillators. Several improvements have been implemented after the S-ICD was approved for use in Europe in 2009. This study reports the results of S-ICD use in a single center, whose experience began late, at the end of 2013. MethodsProspective observational study including consecutive patients with defibrillator indication and no indication for either permanent pacing or cardiac resynchronization who underwent S-ICD implantation. Implant data and long-term follow-up were analyzed. ResultsAn S-ICD was implanted in 50 patients who were deemed suitable after electrocardiographic screening. The mean age was 46.9±15 (range, 15-78) years and 72% were male. Thirty eight percent had left ventricular ejection fraction ≤ 35%. The most frequent heart disease was ischemic heart disease (34%), followed by hypertrophic cardiomyopathy (18%). The intermuscular technique was used, with 3 incisions in 10% and 2 incisions in the remaining 90%. Ventricular fibrillation was induced in 49 patients, with 100% effectiveness in their conversion. After a mean follow-up of 18.1 (range, 2.3-44.8) months, there were no late complications requiring surgical revision, the rate of IS was 0%, and 1 patient (2%) experienced appropriate shocks. ConclusionsImprovements in technology, implant technique and device programming, along with appropriate patient selection, have led to outstanding acute and long-term results, especially regarding the absence of both IS and complications requiring surgical revision.Full English text available from:www.revespcardiol.org/en

Subcutaneous defibrillators for dialysis patients.

Defibrillation can be successfully provided by the subcutaneous implantable cardioverter defibrillator (ICD) without the leads. In contrast, traditional ICDs require leads that can cause central venous stenosis, lead-induced endocarditis, and carry the risk of tricuspid regurgitation by valve adhesion, perforation, coaptation interference, or entanglement. Central venous stenosis, infection, and tricuspid regurgitation are all critically important considerations in hemodialysis patients. Recent reports are supporting the use of subcutaneous ICDs in renal patients maintained on long-term hemodialysis. This article provides the risks associated with leads of traditional defibrillators and raises awareness of the subcutaneous ICD and their benefits for hemodialysis patients.

Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States

Trends and in-hospital outcomes associated with early adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the United States have not been described. To describe early use of the S-ICD in the United States and to compare in-hospital outcomes among patients undergoing S-ICD vs transvenous (TV)-ICD implantation. A retrospective analysis of 393 734 ICD implants reported to the National Cardiovascular Data Registry ICD Registry, a nationally representative US ICD registry, between September 28, 2012 (US Food and Drug Administration S-ICD approval date), and March 31, 2015, was conducted. A 1:1:1 propensity-matched analysis of 5760 patients was performed to compare in-hospital outcomes among patients with S-ICD with those of patients with single-chamber (SC)-ICD and dual-chamber (DC)-ICD. Analysis of trends in S-ICD adoption as a function of total ICD implants and comparison of in-hospital outcomes (death, complications, and defibrillation threshold [DFT] testing) among S-ICD and TV-ICD recipients. Of the 393 734 ICD implants evaluated during the study period, 3717 were S-ICDs (0.9%). A total of 109 445 (27.8%) of the patients were female; the mean (SD) age was 67.03 (13.10) years. Use of ICDs increased from 0.2% during the fourth quarter of 2012 to 1.9% during the first quarter of 2015. Compared with SC-ICD and DC-ICD recipients, those with S-ICDs were more often younger, female, black, undergoing dialysis, and had experienced prior cardiac arrest. Among 2791 patients with S-ICD who underwent DFT testing, 2588 (92.7%), 2629 (94.2%), 2635 (94.4%), and 2784 (99.7%) were successfully defibrillated (≤65, ≤70, ≤75, and ≤80 J, respectively). In the propensity-matched analysis of 5760 patients, in-hospital complication rates associated with S-ICDs (0.9%) were comparable to those of SC-ICDs (0.6%) (P = .27) and DC-ICD rates (1.5%) (P = .11). Mean (SD) length of stay after S-ICD implantation was comparable to that after SC-ICD implantation (1.1 [1.5] vs 1.0 [1.2] days; P = .77) and less than after DC-ICD implantation (1.1 [1.5] vs 1.2 [1.5] days; P < .001). The use of S-ICDs is rapidly increasing in the United States. Early adoption has been associated with low complication rates and high rates of successful DFT testing despite frequent use in patients with a high number of comorbidities.

An Entirely Subcutaneous Implantable Cardioverter–Defibrillator

Background Implantable cardioverter–defibrillators (ICDs) prevent sudden death from cardiac causes in selected patients but require the use of transvenous lead systems. To eliminate the need for venous access, we designed and tested an entirely subcutaneous ICD system. Methods First, we conducted two short-term clinical trials to identify a suitable device configuration and assess energy requirements. We evaluated four subcutaneous ICD configurations in 78 patients who were candidates for ICD implantation and subsequently tested the best configuration in 49 additional patients to determine the subcutaneous defibrillation threshold in comparison with that of the standard transvenous ICD. Then we evaluated the long-term use of subcutaneous ICDs in a pilot study, involving 6 patients, which was followed by a trial involving 55 patients. Results The best device configuration consisted of a parasternal electrode and a left lateral thoracic pulse generator. This configuration was as effective as a transvenous I...

Implantable Cardioverter-Defibrillator Lead Performance

Implantable cardioverter-defibrillators (ICDs) have revolutionized the treatment of patients at risk for sudden cardiac death. In the nearly 3 decades since the first human ICD implant,1 millions of devices have been implanted worldwide and innumerable lives have been saved. Successful resuscitation of a potentially lethal ventricular arrhythmia by an ICD system depends on successful arrhythmia detection and timely delivery of therapy. Both the ICD generator and the ICD lead are critical components of this system. The lead, in particular, is literally a lifeline whose purpose is to convey critical information about the heart’s rhythm to the ICD generator and, in turn, to deliver life-sustaining therapy when needed. Failure of an ICD lead may result in significant clinical events, including failure to pace, failure to defibrillate, inappropriate shocks, and even death. Article p 2727 ICD leads, like many medical technologies, have undergone a remarkable transformation. Epicardial leads, which necessitated a thoracotomy for lead placement, have given way to transvenous leads, which are easier to implant, less costly, and associated with decreased morbidity and mortality.2 Important advances in transvenous lead technology, such as the development of steroid elution, smaller diameter leads, novel insulations, and multipolar leads, have translated into meaningful clinical benefits for patients. Although modern ICD leads consist primarily of electrodes, conductors, insulation, and a fixation mechanism to attach the lead to the myocardium, lead design and performance vary from model to model. Indeed, monitoring of performance is critical not only to identify products with increased failure rates but also to provide physicians and patients with realistic expectations of device performance. In the current issue of Circulation , Eckstein et al add to our understanding of ICD lead performance.3 The investigators conducted a retrospective analysis of 1317 consecutive patients who received ICD systems (including 38 different ICD lead …