Conventional Implantable Cardioverter-defibrillators Research Articles

Trends in adoption of extravascular cardiac implantable electronic devices: the Dutch cohort.

Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry arisk of pocket- and lead-related complications in particular. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on patient or centre characteristics related to the actual adoption of EVDs are lacking. To assess real-world nationwide trends in EVD adoption in the Netherlands. Using the Netherlands Heart Registration, all consecutive patients with ade novo S‑ICD or conventional single-chamber ICD implantation between 2012-2020, or de novo LP or conventional single-chamber pacemaker implantation between 2014-2020 were included. Trends in adoption are described for various patient and centre characteristics. From 2012-2020, 2190 S‑ICDs and 10,683 conventional ICDs were implanted; from 2014-2020, 712 LPs and 11,103 conventional pacemakers were implanted. The general use has increased (S-ICDs 8 to 21%; LPs 1 to 8%), but this increase seems to have reached aplateau. S‑ICD recipients were younger than conventional ICD recipients (p < 0.001) and more often female (p < 0.001); LP recipients were younger than conventional pacemaker recipients (p < 0.001) and more often male (p = 0.03). Both S‑ICDs and LPs were mainly implanted in high-volume centres with cardiothoracic surgery on-site, although over time S‑ICDs were increasingly implanted in centres without cardiothoracic surgery (p < 0.001). This nationwide study demonstrated arelatively quick adoption of innovative EVDs with aplateau after approximately 4years. S‑ICD use is especially high in younger patients. EVDs are mainly implanted in high-volume centres with cardiothoracic surgery back-up, but S‑ICD use is expanding beyond those centres.

Trends in adoption of extravascular cardiac implantable electronic devices: the Dutch cohort

Abstract Introduction Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of mainly pocket- and lead-related complications. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on the actual adoption of EVDs for patient or center characteristics is lacking. Purpose To assess real-world nationwide trends in adoption of EVDs in the Netherlands. Methods Using the Netherlands Heart Registration, all consecutive patients with a de novo S-ICD or conventional single-chamber ICD implantation between 2012-2020, or with a de novo LP or conventional single-chamber pacemaker implantation between 2014-2020 were included. Trends in adoption of EVDs are described for different patient and hospital characteristics (tertiles of device-implanting volume and whether cardiothoracic surgery back-up was available). Differences between patients with EVDs and non-EVDs and differences between implanting centers of EVDs and non-EVDs were tested for by Student’s T-test, Chi-square and Fisher’s exact test. Trends in adoption over time were calculated with linear and logistic regression analysis. Results From 2012-2020, 2190 S-ICDs and 10683 conventional ICDs were implanted; from 2014-2020, 712 LPs and 11103 conventional pacemakers were implanted. The general adoption of both increased (S-ICDs, 8% to 21%; LPs, 1% to 8%), but the increase seems to reach a plateau (Fig. 1). S-ICD recipients were younger than conventional ICD recipients (p&amp;lt;0.001) and more likely to be female (p&amp;lt;0.001); LP recipients were younger than conventional pacemaker recipients (p&amp;lt;0.001) and more likely to be male (p=0.03). Both S-ICDs and LPs were mainly implanted in high-volume centers with thoracic surgery on-site (Fig. 2). Conclusions In this nationwide study we observed a relative quick adoption of innovative EVDs with a plateau after approximately 4 years. The relative adoption of S-ICDs is especially high in younger patients. EVDs are overall mainly implanted in high-volume centers with cardiothoracic surgery available. As LPs can only be implanted in centers with cardiothoracic surgery in the Netherlands, this may have limited its adoption.

Use of subcutaneous cardioverter-defibrillator. First cases reported from National Institute of Cardiology Ignacio Chávez-Mexico.

The transvenous implantable cardioverter defibrillator (ICD) is the treatment of choice for the prevention of sudden cardiac death (SCD). Its use could be restricted when device-related infections occurs or in the pediatric population. In the later, an ICD represents a challenge, due to the minimal dimensions of the venous system in children, the length of the electrodes, the size of the generator, as well as the anatomical complexity in cases with associated congenital heart disease. This article presents the first Mexican patients with a subcutaneous ICD (SC-ICD) implant as a therapy for the prevention of SCD. The first four cases were implanted at the Ignacio Chávez National Institute of Cardiology with a SC-ICD (Emblem, Boston Scientific, USA), three of them were pediatric patients, including the first implant of this type of device in a pediatric patient in Latin America. The 3-incision and 2-incision techniques were used under general anesthesia. A successful implantation was obtained with the 3-incision technique in the first 2 cases and the last 2 with the 2-incision technique. Proper functioning of the device was corroborated in the operating room with proof of appropriate therapy (65 J) for ventricular fibrillation induced with 50 Hz stimulation. No immediate complications were observed. One patient had appropriate shocks two months after the implant. During follow-up, one child developed skin erosion at the level of the curve of the electrode on the sternum, with no signs of infection. In the operating room, the damaged skin was resected, the barrel and the fixation silk were removed, surgical lavage was performed, and the skin was closed again, thus avoiding removal of the system. The SC-ICD is an alternative therapy to the transvenous ICD. It can be considered first choice in subjects who do not require ventricular pacing, including pediatric patients. Skin complications can occur but do not pose a threat as venous complications of conventional ICDs.

Validation of a transthoracic impendance sensor for screening of sleep apnea in CIED patients: a pooled analysis of AIRLESS and UPGRADE

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Scientific grant support from the Boston Scientific Investigator Sponsored Research (ISR) Committee, Boston Scientific, St. Paul, MN, USA. Background/Introduction Cardiac implantable electronic devices and their integrated thoracic impedance sensors, meant to detect sleep apnea, are available for over a decade now. Despite its usage in daily clinical practice, there is only limited data on its diagnostic accuracy. Purpose To further validate an apnea sensor by using polysomnography (PSG) and investigate subgroups with potential differences in diagnostic accuracy. Methods AIRLESS and UPGRADE were prospective investigator driven trials meant to validate an apnea sensor. Patients, who either fulfilled the criteria for implantation of an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) or upgrading to CRT according to current guidelines were eligible for enrolment. Sleep apnea and its severity, measured by apnea-hypopnea index (AHI), were exclusively assessed by PSG. PSG was conducted in a time interval of 1 to 3 months post implantation of the device. For direct comparison, the apnea sensor derived respiratory disturbance index (RDI) was used from the identical night. Bivariate correlations (spearman coefficient) as well as the Bland-Altmann method were applied to assess diagnostic accuracy of the apnea sensor. Results Overall, 80 patients were analysed, out of whom the majority (n = 35, 43.8%) were diagnosed with central sleep apnea. Sixteen (20.0%) patients received a conventional ICD system, whereas 21 (26.3%) were implanted a CRT-P and 43 (53.8%) a CRT-D. Atrial fibrillation was known in 50.0% (n=40) of patients, 45 patients suffered from periodic leg movement syndrome (PLMS, 56.3%). In the overall cohort, the sensor derived RDI correlated significantly with the AHI (r = 0.61, p &amp;lt; 0.001) with a mean difference (MD) of -12.6 (95% CI -38.2 – 13.0). The sensor did specifically perform well in patients without atrial fibrillation (r = 0.80, p &amp;lt; 0.001; MD -9.0, 95% CI -30.4 – 12.5), while the presence of PLMS did not affect the accuracy of measurements (PLMS: r = 0.60, p = 0.007, MD -16.1, 95% CI -43.9 – 11.8 vs. no PLMS: r = 0.62, p = 0.001, MD -9.9, 95% CI -32.8 – 12.9). Furthermore, the RDI was found to correlate well in patients with central sleep apnea (r = 0.61, p = 0.013), although similar overestimation was observed (MD -11.6, 95% CI -35.4 – 12.2) as in other subgroups. Conclusion In an exclusive heart failure cohort, the apnea sensor did correlate well with the PSG derived AHI. Although similar correlation is found in most subgroups, there remains to be a decent overestimation of events.

Effect of Novel Programming on Inappropriate Implantable Cardioverter-Defibrillator Therapy in Patients With Very Low Ejection Fraction (from A MADIT-RIT)

The Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy showed a significant reduction in the risk of inappropriate therapy in patients with a programmed high-rate cutoff ≥200 beats per minute or delayed therapy for events ≥170 beats per minute compared with conventional programming. We aimed to characterize outcomes by left ventricular ejection fraction (LVEF) ranges for patients with high-rate, delayed, or conventional implantable cardioverter-defibrillator programming. We assessed the effect of LVEF (LVEF &lt;15%, LVEF 15% to 25%, LVEF &gt;25%) on the risk of inappropriate conventional implantable cardioverter-defibrillator therapy and death in Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy. Inappropriate therapies and death were independently evaluated by the adjudication committee. Statistical methods involved Kaplan-Meier time-to-event graphs and Cox proportional hazards regression analyses. The study involved 140 patients (9%) with LVEF 15%, 585 with LVEF 15% to 25% (39%), and 774 with LVEF &gt;25% (52%). High-rate or delayed programming significantly reduced the risk of inappropriate therapy compared with conventional programming in patients with all LVEFs (p &lt;0.001 for all LVEF). Patients with LVEF &lt;15% had an exceptional 97% lower risk of inappropriate therapy, with high-rate programming than conventional programming (hazard ratio 0.028, p=0.001), without an increase in mortality. High-rate and delayed programming is superior to conventional programming in all LVEF ranges, without adverse effects.

Quality of life in patients with a subcutaneous vs. transvenous implantable cardioverter-defibrillator.

The implantable cardioverter-defibrillator (ICD) and subcutaneous ICD (S-ICD) are well-accepted life-saving devices for treating potentially lethal ventricular arrhythmia, but little is known about quality of life (QoL) in patients with S-ICD and ICD. Our study aimed to compare QoL in patients with S-ICD and ICD. All consecutive patients who had S-ICD implanted between October 2015 and September 2021 were included in the study. A cohort of transvenous ICD (TV-ICD) patients was matched to S-ICD subjects by sex, age, indications for the device, and type of prevention. All patients were requested to fulfill two standardized questionnaires to assess QoL: 36-Item Short Form Health Survey (SF-36) and Minnesota Living with Heart Failure Questionnaire (MLHFQ) 6 months after device implantation. Patients with S-ICD (n = 49) and TV-ICD (n = 49) did not differ regarding baseline characteristics. There were no statistically significant differences between S-ICD and TV-ICD subgroup, both for mental and physical QoL assessed in SF-36 and MLHFQ (all P = NS). The median MLHFQ total score was 24 (9-41) for S-ICD and 28 (14-43) for TV-ICD (P = 0.83). The median total score for the SF-36 questionnaire was 62.5 (29-86) vs. 59 (38-77) for S-ICD and TV-ICD, respectively (P = 0.78). Quality of life after device implantation does not differ significantly between the groups of patients with subcutaneous and conventional implantable cardioverter-defibrillator.

The efficacy of single-lead implantable cardioverter-defibrillator with atrial sensing dipole to detect atrial fibrillation and to reduce inappropriate therapy according to atrial sensing ON or OFF: Rationale and design of the SMART-CONTROL study, a prospective multicenter randomized trial

Few studies have compared the efficacy of single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (VDD-ICD) and conventional single-chamber ICD from the aspect of atrial fibrillation (AF) detection or inappropriate ICD therapy reduction. In the SMART-CONTROL trial (NCT03932604), we primarily aim to investigate whether the atrial sensing capability of VDD-ICD is useful in AF detection and inappropriate therapy reduction by randomly activating or deactivating the atrial sensing function. This study was designed as a prospective, multicenter, open-label, randomized trial to enroll 640 patients with no history of clinical AF or rhythm control for AF within 1 year who were undergoing the implantation of VDD-ICD system. Patients are assigned randomly to atrial sensing "ON" or "OFF" group, with crossover allowed during follow-up. The coprimary outcomes are the incidence of AF detection and inappropriate ICD therapy over a 2-year follow-up period. The secondary outcomes include non-AF atrial tachyarrhythmia, ventricular tachyarrhythmia with or without ICD therapy, thromboembolic events, bleeding, heart failure hospitalization, mortality, a composite of adverse cardiovascular events, and long-term atrial sensing stability or variability. We expect that this trial can evaluate the efficacy of a single-lead ICD system on various clinical outcomes including AF detection and inappropriate therapy reduction, and ultimately provide guidance to selection of ICD system.

Incremental value of atrial sensing in the diagnosis of ICD recordings: findings from the THINGS registry

Abstract Background Automatic diagnosis of implantable cardioverter defibrillator (ICD) requires confirmation through analysis of electrograms (EGM) recordings by an electrophysiologist (EP) specialist. Purpose To investigate whether the atrial sensing capability in single-chamber ICD improves reliability in episodes assessment. Methods The THINGS registry enrolled 526 consecutive patients without atrial pacing indication who underwent single-lead ICD implantation. Of them, 343 patients received a conventional single-chamber ICD (ICD VR) and 183 a single-lead ICD with atrial sensing capability (ICD DX, BIOTRONIK). Device-detected ventricular episodes were independently classified by two experienced electrophysiologists as ventricular (VT) or supraventricular tachycardia (SVT) by analyzing the EGMs. In case of disagreement, a third experienced EP specialist, blinded to previous assessment, was consulted. The inter-rate reliability was evaluated using the Cohen's kappa (k) coefficient in the ICD VR and ICD DX group. Results A total 441 (383 in the ICD VR and 58 in the ICD DX group) device-detected events were analyzed. Using ventricular EGM alone for ICD VR patients, the proportion of observed agreement between the 1st and 2nd adjudicator was 86.4% consisting of 268 (70.0%) episodes confirmed as VT and 63 (16.4%) classified as SVT. The k coefficient was 0.61 and no agreement was reached for 52 (13.6%) tracings. For them, the third assessment had low agreement with both previous EP evaluations (the k coefficients 1st/3th and 2nd/3th EP specialist were 0.03 and −0.05, respectively). In ICD DX group, with available atrial EGM, the proportion of observed agreement in the first stage improved to 93.0%: 44 (75.8%) episodes were adjudicated as VT and 10 (17.2%) as SVT with a k=0.79. Only 4 (7.0%) recordings had a discordant classification. For them, the 2nd and 3rd EP specialist had perfect agreement (k=1). Conclusions Atrial sensing capability improves EP specialist assessment of ICD episodes allowing dual EGMs analysis. Misinterpretation of ICD recordings may thus be less common in ICD DX than in conventional single-chamber ICD VR and may improve clinical decisions. Funding Acknowledgement Type of funding sources: None.

Subcutaneous implantable cardioverter defibrillator in children and adolescents: results from the S-ICD "Monaldi care" registry.

Implantable cardioverter defibrillators (ICD) are widely accepted therapy in children and adolescents who are survivors of cardiac arrest or for high-risk patients with inheritable channelopathies, cardiomyopathies, or congenital heart disease. Initial experience with subcutaneous ICD (S-ICD) systems has shown a high efficacy in adults. However, the use of S-ICD in children and adolescents implies some specific considerations, as the safety for these patients is unknown and recommendations among physicians may vary widely. We reviewed the data and studied the indications for S-ICD in children and adolescents and discuss the preliminary clinical experience. From a cohort of 297 patients enrolled in the S-ICD "Monaldi care" registry that encompass all the patients implanted in the Monaldi Hospital of Naples, we considered 21 consecutive children and adolescents (mean age 13.9 years, range 8-18 years, mean body weight 59.3 kg, range 38-100 kg) who underwent S-ICD implant from April 2014 to June 2020. Mean follow-up was 41.9±21.9 months. Only one patient presented, 6 weeks after implantation, skin erosion at the inferior parasternal incision that resolved after antibiotic therapy, without the necessity of any system revision. Two patients experienced appropriate shocks and four inappropriate shocks, due to T wave oversensing or atrial arrhythmia. Only one patient, with arrhythmogenic right ventricular dysplasia, required a system revision after 36 months of the first implantation and then a reintervention with a replacement of the S-ICD by a conventional ICD system. Our experience suggests that the S-ICD device can be used in some children over the age of 8 as well as adults, with a similar rate of unwanted side effects, and early evidence of apparent efficacy.

Innovations in Cardiac Implantable Electronic Devices.

Cardiac implantable electronic devices (CIEDs) are essential for the management of a variety of cardiac conditions, including tachyarrhythmias, bradyarrhythmias, and medically refractory heart failure (HF). Recent advancements in CIED technology have led to innovative solutions that overcome shortcomings associated with traditional devices or address unmet needs. Leadless pacemakers, subcutaneous implantable cardioverter defibrillators (ICDs), and extravascular ICDs eliminate lead-related complications common with conventional pacemakers or ICDs. Conduction system pacing (His bundle pacing and left bundle branch pacing) is a more physiologic method of pacing and avoids the deleterious consequences associated with long-term right ventricular pacing. For HF-related devices, cardiac contractility modulation is an emerging therapy that bridges a gap for many patients ineligible for cardiac resynchronization therapy and has been shown to improve HF symptoms and decrease hospitalizations and mortality in select patients. Implantable pulmonary artery pressure monitors help guide HF management and reduce hospitalizations. Lastly, new phrenic nerve stimulating devices are being utilized to treat central sleep apnea, a common comorbidity associated with HF. While further long-term studies are still underway for many of these new technologies, it is anticipated that these devices will become indispensable therapeutics in the expanding cardiovascular armamentarium.

Kardiális implantálható elektromos eszközök beültetései hazánkban 2017-2020 között

Implantation numbers of conventional antibradycardia pacemakers (PM), implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy PMs and ICDs (CRT-P and D) have shown a minimal increase till 2017. Between 2017–2019 the implantation numbers have remained on a steady state level, the numbers of ILR, CRT-D and conventional ICDs have shown a slight increase, moreover the ratio of CRT-P against CRT-D has decreased. Year of 2020 was a special year due to the SARS-CoV2 pandemic, since the primary implantations without urgent indication have been limited and been postponed. In the last 2 years close speciality cooperation between the National Health Fund and the Board of the Hungarian Society of Cardiology Working Group of Cardiac Pacing and Electrophysiology established the reimbursement of implantation of leadless pacemakers and subcutaneous ICDs. Since 2020 a new special reimbursement possibility for His-bundle pacing modality for chronic heart failure patients without LBBB.

Prevention of Sudden Cardiac Death: Focus on the Subcutaneous Implantable Cardioverter-Defibrillator.

The implantable cardioverter-defibrillator (ICD) is the most effective therapy to prevent sudden cardiac death (SCD) in high-risk patients. To overcome infections and failure of transvenous leads, the most frightening complications of conventional ICDs, a completely subcutaneous ICD (S-ICD) has been developed and is currently adopted in routine clinical practice. In view of their long life-expectancy, low competitive risk of dying from non-arrhythmic causes, and high lifetime risk of lead-related complications requiring surgical revisions, young patients with cardiomyopathies and inherited arrhythmia syndromes have traditionally been considered ideal candidates for the S-ICD. However, as growing evidence supported S-ICD safety and efficacy, initial niche implant indications were abandoned in favor of a widespread use of this technology, that is currently adopted in common ICD candidates with severe left ventricular dysfunction. Indeed, guidelines recommend S-ICD implantation as an alternative to TV-ICDs in all ICD candidates, unless pacing is required. This review focuses on the contemporary experience with the S-ICD and explores future scenarios in which device-to-device communication will enable to combine leadless therapies.

P1147Complications in young ICD patients - a retrospective analysis

Abstract Introduction In specific situations implantable cardioverter defibrillator (ICD) therapy is recommended for patients under the age of 40 years. Due to the active lifestyle of this patient population, complication rates in devices with conventional transvenous electrodes may be higher than for the remaining population. Methods The ICD-YOUNG study is a retrospective analysis of consecutive patients ≤ 40 years undergoing transvenous or subcutaneous ICD (s-ICD) implantation, device change or lead revision at our centre between July 2006 and December 2017. Rehospitalization for lead failure or device battery depletion was documented. Results Out of 586 patients undergoing ICD implantation, 35 patients (6.0%) were ≤ 40 years. Mean age was 30.0 ± 7.2 years, 48.6% were female, 37.1% received ICD therapy for primary prevention and 11.4% primarily received s-ICD. Median follow up was 7.3 (interquartile range, 1.8-12.0) years, with a lower follow up duration in s-ICD patients than conventional ICD patients (median, 2.9 vs. 9.0 years). Over the course of follow-up, 37.1% received successful anti-tachycardia therapy. 19.4% of patients in the conventional ICD group had right ventricular lead problems requiring intervention, while none of the s-ICD patients had to be revised. Time to first device change due to battery depletion and/or device upgrade was similar in young and remaining patients (median 5.4 vs 6.0 years, p = 0.23). Discussion Young patients requiring ICD have a high rate of lead problems. In most young patients, s-ICD therapy is an encouraging alternative to conventional ICD therapy with a lower lead failure rate.

Intermuscular S-ICD Implantation in Pediatric Patients

The use of conventional implantable cardioverter-defibrillators (ICDs) in children presents important technical challenges. We present the surgical technique necessary to adapt the subcutaneous ICD (S-ICD) implantation designed for adults, to children, including patients weighing less than 20 kg. The implant procedure implies a two-incision technique and interfascial serratus anterior-latissimus dorsi dissection to accommodate the device. S-ICD implantation was successfully performed in three patients of 19, 28, and 24 kg, respectively, two of them suffered cardiorespiratory arrest. Intermuscular thoracic implantation of S-ICD might represent an effective strategy for primary or secondary prevention of sudden cardiac death in pediatric patients.

Estimation of OptiVol Alert for Identifying Heart Failure in Conventional Bradyarrhythmia Pacing Patients with Preserved Left Ventricular Function: A Multicenter Prospective Cohort Study (OptiVol Study)

BACKGROUND: The usefulness of OptiVol, an algorithm to detect heart failure (HF) using continuous intrathoracic impedance monitoring, is established in high-power device patients with reduced left ventricular ejection fraction (LVEF). However, the utility of OptiVol in conventional bradyarrhythmia pacing patients with preserved LVEF is not established. OBJECTIVES: This study aimed to describe the utility of the OptiVol alert feature in monitoring HF in conventional pacemaker or implantable-cardioverter defibrillator (ICD) patients with preserved LVEF. METHODS: Forty-three patients implanted with a conventional pacemaker or ICD with the OptiVol function were enrolled. Of these, 39 completed the observation period. OptiVol fluid index and cumulative percentage of right ventricular pacing (%RVp) were obtained every three months for 12 months after device implantation. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) to predict HF hospitalization of the OptiVol alert defined by an OptiVol fluid index &gt;100Ω-day or &gt;60Ω-day were compared. The combination of OptiVol positivity and right ventricular pacing site and/or %RVp &gt;40% for the prediction of HF hospitalization were also assessed. RESULTS: Three patients (7.6%) had HF hospitalization within one year after device implantation. The sensitivity, specificity, PPV and NPV of OptiVol alert definition with OptiVol fluid index &gt;100Ω-day were 100%, 64%, 19%, and 100%, while those of OptiVol alert definition with OptiVol fluid index &gt;60Ω-day were 100%, 42%, 13% and 100%, respectively. These parameters were improved by the combination of OptiVol fluid index &gt;100Ω-day and RV apex pacing and/or %RVp &gt;40%, attaining values of 100%, 97%, 75%, and 100%, respectively; by the combination of OptiVol alert and RV apex pacing; or their combination. CONCLUSION: The OptiVol alert using cut-off value of 100Ω-day would be useful for the prediction of HF hospitalization in conventional bradyarrhythmia pacing patients with preserved LVEF. The utility of OptiVol alert would be emphasized in patients with RV apex pacing and/or %RVp &gt;40%. KEYWORDS: Heart failure; bradycardia; cardiac pacing; OptiVol; intrathoracic impedance

Multicentre early experience with totally subcutaneous cardioverter-defibrillators in Poland.

IntroductionImplantable cardioverter-defibrillators (ICD) have a strong position in the prevention of sudden death. Nowadays, the most commonly used high-energy cardiac devices are transvenous ICDs. A new technology of totally subcutaneous ICDs (S-ICD) was invented and recently introduced into clinical practice in order to reduce lead-related complications of conventional ICDs. The aim of this paper is to present early experience with this new technology implemented in a few centres in Poland.Material and methodsMedical records of patients who had S-ICD-related interventions in Poland were retrospectively analysed.ResultsDuring the first year of S-ICD introduction into the Polish health system 18 patients underwent surgery connected with S-ICDs. Majority of them (17 patients) were implanted de novo. In one patient surgical revision of a device implanted abroad was performed. Most of patients (78%) had S-ICDs implanted for secondary prevention. Inability of transvenous system implantation due to venous access obstruction or high risk of infection related with transvenous leads accounted for 83% of indications for S-ICD. Only in three patients were S-ICDs implanted due to young age and active mode of life. The implantations of S-ICDs were performed without important early or late complications. During follow-up one patient had episodes of ventricular arrhythmia successfully terminated with high-energy shocks. One patient died due to progression of heart failure.ConclusionsS-ICD implantation procedure has been successfully and safely introduced in Polish clinical routine. Nevertheless, despite clear indications in recent ESC guidelines, this therapy is not directly reimbursed in Poland and needs individual application for refund.

Subcutaneous Implantable Cardioverter Defibrillators: An Overview of Implantation Techniques and Clinical Outcomes.

Sudden Cardiac Death (SCD) is a significant health problem worldwide.Multiple randomized controlled trials have shown that Implantable Cardioverter Defibrillators (ICDs) are effective life-saving management option for individuals at risk of SCD in both primary and sec-ondary prevention. Although the conventional transvenous ICDs (TV-ICDs) are safe and effective, there are potential complications associated with its use, including localized pocket or wound infection or systematic infection, a vascular access related complication such as pneumothorax, and venous thrombosis, and lead related complications such as dislodgement, malfunction, and perforation.Furthermore, transvenous leads placement may not be feasible in certain patients like those with ve-nous anomaly or occlusion, or with the presence of intracardiac shunts. Transvenous leads extraction, when needed, is associated with considerable morbidity & mortality and requires significant skills and costs. Totally subcutaneous ICD (S-ICD) is designed to afford the same life-saving benefit of the conventional TV-ICDs while avoiding the shortcomings of the TV-leads and to simplify the implant techniques and hence expand the use of ICDs in clinical practice. It becomes commercially available after receiving CE mark in 2009, and its use increased significantly after its FDA approval in 2012. This review aims to give an overview of the S-ICD system components, implantation procedure, clin-ical indications, safety, efficacy, and future directions.

Subcutaneous implantable cardioverter defibrillator in cardiomyopathies and channelopathies.

: Cardiomyopathies and channelopathies are heterogeneous disorders that increase the risk of sudden cardiac death (SCD). Implantable cardioverter-defibrillator (ICD) therapy is safe and effective for preventing SCD in patients at risk for malignant ventricular arrhythmias. Because of the poor positive predictive value of current risk stratification tools, the majority of patients implanted with an ICD will never receive a life-saving therapy but will be exposed to the risk of complications such as device infection, lead failure and inappropriate therapy. Subcutaneous ICD (S-ICD) now constitutes a valuable alternative to conventional transvenous ICD in patients with cardiomyopathies and channelopathies as it provides protection from SCD while avoiding the risks of intravascular lead infection or failure. This may be particularly advantageous for young patients with a very long life expectancy. On the other hand, S-ICD cannot deliver antitachycardia pacing or antibradycardia pacing. The purpose of this article is to review the available evidence and the future perspectives of S-ICD therapy in patients with cardiomyopathies or channelopathies.

Cost Saving Potential of an Early Detection of Atrial Fibrillation in Patients after ICD Implantation.

Atrial fibrillation (AF) is a relevant comorbidity in recipients of implantable cardioverter-defibrillators (ICD). Latest generation single-chamber ICD allow the additional sensing of atrial tachyarrhythmias and, therefore, contribute to the early detection and treatment of AF, potentially preventing AF-related stroke. The present study aimed to measure the impact on patient-related costs of this new ICD compared to conventional ICD. A Markov model was developed to simulate the long-term incidence of stroke in patients treated with a single-chamber ICD with or without atrial sensing capabilities. The median annual cost per patient and its difference, the number of strokes avoided, and the cost per stroke avoided were estimated. During a 9-year horizon, the costs for the ICD and stroke treatment were €570 per patient-year for an ICD with atrial sensing capabilities and €491 per patient-year for a conventional ICD. Per 1,000 patients, 4.6 strokes per year are assumed to be avoided by the new device. Higher CHA2DS2-VASc scores are associated with higher numbers of avoided strokes and larger potential for cost savings. Apart from clinical advantages, the use of ICD with atrial sensing capabilities may reduce the incidence of stroke and, in high-risk patients, may also contribute to reduce overall health care costs.

Exploring the patients' experiences of living with a subcutaneous implantable cardioverter defibrillator.

The implantable cardioverter defibrillator provides effective treatment for the prevention of sudden cardiac arrest but significant risks associated with transvenous implantation persist. The subcutaneous implantable cardioverter defibrillator has proven to be an alternative and innovative treatment option for select patients to mitigate these risks. Obtaining the patients' perspectives can provide clinicians with essential information to guide implant selection, procedural decision-making, and support patient management. Conventional implantable cardioverter defibrillator patients have reported shock-related anxiety, fear, insufficient education, and challenges adapting to physical and psychological changes. Little evidence exists to determine whether differences between the subcutaneous implantable cardioverter defibrillator and conventional implantable cardioverter defibrillator allow for the transferability of our current knowledge to the care and management of this population. The purpose of this study was to explore patients' experiences of living with a subcutaneous implantable cardioverter defibrillator including the decision-making process, implant, and follow-up care processes. Using an exploratory qualitative approach, semi-structured interviews were conducted by telephone with 15 participants who underwent subcutaneous implantable cardioverter defibrillator implant. Analysis revealed five main themes: (a) influences on decision-making; (b) unmet education needs; (c) physical impact; (d) psychological impact; and (e) recommendations. As a new technology, little knowledge of the subcutaneous implantable cardioverter defibrillator exists outside of the tertiary implanting sites, therefore developing new strategies to increase learning and dissemination is essential. Although similarities exist in our findings to those of conventional implantable cardioverter defibrillators, there are significant differences in the decision-making process and physical impact which require individualized care planning and development of strategies to provide a patient-centered approach to care.