Performance of the entirely subcutaneous ICD in borderline indications.
TL;DR: The use of the S-ICD™ was safe in patients with borderline or unclear indication for ICD implantation in this study and may be considered as a possible alternative in cases of borderline indications and clinical uncertainty when decision pro- ICD implantation is made.
Abstract: The subcutaneous ICD (S-ICD™) is an important advance in device therapy for prevention of sudden cardiac death (SCD). In some patients, decision pro- or contra-ICD implantation is particularly challenging due to inconsistent data on risk of ventricular tachyarrhythmias or sudden cardiac death, rare entities, special medical or family history, or patients’ wishes. Whether decision-making in these borderline cases has been facilitated with the new option of a S-ICD™ is unknown. All patients with an implanted S-ICD™ without a class I or IIa recommendation for primary prophylaxis of sudden cardiac death in the current guidelines (n = 30 patients) in our large-scaled single-centre S-ICD™ registry (n = 249 patients) were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a mean follow-up of 40 months. In all patients S-ICD™ implantation was performed for primary prevention of SCD. Of all 30 patients with an overall mean age of 40.5 ± 15.6 years, 17 were male (57%). The mean left ventricular ejection fraction (LVEF) was 54.5 ± 9.9%. Indication were highly variable and ranged from structural heart disease, nsVT and LV-EF > 35% to patients with polymorphic non-sustained ventricular tachycardia (nsVT) and suspect syncope. During follow-up, six episodes of sustained ventricular tachyarrhythmias and four episodes of ventricular fibrillation (VF) were adequately terminated in three patients (10%). Two of these patients were implanted for polymorphic nsVT and previous syncope without structural heart disease. In three patients, T-wave-oversensing and in one patient also P-wave-oversensing resulted in an inappropriate shock (five in total), two additional episodes of oversensing ended before shock delivery. There were no S-ICD™ system-related infections. In five patients S-ICD™ replacement was performed due to battery depletion (four regular, one premature). In five patients, ablation procedures were performed after implantation (four because of frequent symptomatic ventricular extra beats, one because of atrial flutter). Change to a transvenous system was necessary in two patients due to need for antibradycardia pacing. The use of the S-ICD™ was safe in patients with borderline or unclear indication for ICD implantation in our study. Of note, during a relatively short mean follow-up there were several appropriate therapies, especially for VF in these patients. On the other hand, oversensing also occurred in about 10% of patients, while lead problems were not problematic in this collective. S-ICD™ implantation may be considered as a possible alternative in cases of borderline indications and clinical uncertainty when decision pro-ICD implantation is made. Incidence of arrhythmias was quite high and mostly consisted of VF. Nevertheless, patient education seems even more important as there is a considerable risk for inappropriate therapies as well.
Citations
More filters
TL;DR: This first multicentre study investigating patients with supraventricular tachycardia and dual antegrade conduction in the AV node demonstrates that catheter ablation is safe and effective while long-term patient outcome is good.
Abstract: Supraventricular tachycardias induced by dual antegrade conduction via the atrioventricular (AV) node are rare but often misdiagnosed with severe consequences for the affected patients. As long-term follow-up in these patients was not available so far, this study investigates outcomes in patients with dual antegrade conduction in the AV node. In this multicentre observational study, patients from six European centres were studied. Catheter ablation was performed in 17 patients (52 ± 16 years) with dual antegrade conduction via both AV nodal pathways between 2012 and 2018. Patients with the final diagnosis of a manifest dual AV nodal non-re-entrant tachycardia had a mean delay of the correct diagnosis of over 1 year (range 2–31 months). Two patients received prescription of non-indicated oral anticoagulation, two further patients suffered from inappropriate shocks of an implantable cardioverter defibrillator. In 12 patients, a co-existence of dual antegrade and re-entry conduction in the AV node was present. Mean fast pathway conduction time was 138 ± 61 ms and mean slow pathway conduction time was 593 ± 134 ms. Successful radiofrequency catheter ablation was performed in all patients. Post-procedurally oral anticoagulation was discontinued, without detection of cerebrovascular events or atrial fibrillation during a long-term follow-up of median 17 months (range 6–72 months). This first multicentre study investigating patients with supraventricular tachycardia and dual antegrade conduction in the AV node demonstrates that catheter ablation is safe and effective while long-term patient outcome is good. Autonomic tone dependent changes in ante- vs. retrograde conduction via slow and/or fast pathway can challenge the diagnosis and therapy in some patients.
5 citations
TL;DR: The subcutaneous ICD has evolved to a potential first option for many patients who have to be protected from sudden cardiac death and certain problems are immanent to the S-ICD (limited re-programming options, size of the generator) and should be addressed in future generations of the ICD.
Abstract: The subcutaneous ICD (S-ICD) has evolved to a potential first option for many patients who have to be protected from sudden cardiac death. Many trials have underlined a similar performance regarding its effectiveness in relation to transvenous ICDs and have shown the expected benefits concerning infective endocarditis and lead failure. However, there have also been problems due to the peculiarities of the device, such as oversensing and myopotentials. In this study, we present patients from a large tertiary centre suffering from complications with an S-ICD and propose possible solutions. All S-ICD patients who experienced complications related to the device (n = 40) of our large-scale single-centre S-ICD registry (n = 351 patients) were included in this study. Baseline characteristics, complications occurring and solutions to these problems were documented over a mean follow-up of 50 months. In most cases (n = 23), patients suffered from oversensing (18 cases with T wave or P wave oversensing, 5 due to myopotentials). Re-programming successfully prevented further oversensing episode in 13/23 patients. In 9 patients, generator or lead-related complications, mostly due to infectious reasons (5/9), occurred. Further problems consisted of ineffective shocks in one patient and need for antibradycardia stimulation in 2 patients and indication for CRT in 2 other patients. In total, the S-ICD had to be extracted in 10 patients. 7 of them received a tv-ICD subsequently, 3 patients refused re-implantation of any ICD. One other patient kept the ICD but had antitachycardic therapy deactivated due to inappropriate shocks for myopotential oversensing. The S-ICD is a valuable option for many patients for the prevention of sudden cardiac death. Nonetheless, certain problems are immanent to the S-ICD (limited re-programming options, size of the generator) and should be addressed in future generations of the S-ICD.
3 citations
14 Jun 2021
TL;DR: Kevin Willy ( kevin.willy@ukmuenster.de ) University Hospital Münster Julia Köbe University Hospital Munich, and Florian Reinke University Hospitalünster, where Kevin Willy worked as a post-graduate student at the University of Munich.
Abstract: Kevin Willy ( kevin.willy@ukmuenster.de ) University Hospital Münster Julia Köbe University Hospital Münster Florian Reinke University Hospital Münster Benjamin Rath University Hospital Münster Christian Ellermann University Hospital Münster Julian Wolfes University Hospital Münster Philipp S Lange University Hospital Münster Lars Eckardt University Hospital Münster Gerrit Frommeyer University Hospital Münster
1 citations
TL;DR: Graphic abstract as mentioned in this paper ] is an example of such an approach, but it is not suitable for children's games, and it cannot be used in games with children's disabilities.
Abstract: Graphic abstract
1 citations
Cites background from "Performance of the entirely subcuta..."
...Consecutively, because of an already existing AVB I° and sinusbradycar‐ dia, a 2‐lead ICD was implanted for primary prophylactic reasons in this patient with positive family history for SCD [12]....
[...]
...Here, we report on a 37‑year‑old female patient pre‑ sented at our center in 2017 for family screening of numer‑ ous cases of SCD....
[...]
...In the heart, mutations in the LMNA gene may cause cardiomyopathy, conduction disease, atrial and ventricular arrhythmias as well as sudden cardiac death (SCD) [1]....
[...]
...Consecutively, because of an already existing AVB I° and sinusbradycar‑ dia, a 2‑lead ICD was implanted for primary prophylactic reasons in this patient with positive family history for SCD [12]....
[...]
TL;DR: The Journal of Cardiothoracic and Vascular Anesthesia (JCAN) annual series on electrophysiology in relation to vascular anesthesia is presented in this paper, which focuses on the convergent procedure, His-bundle pacing, a comparison of subcutaneous and transvenous defibrillator therapies, and the 2020 practice advisory update for the perioperative management of patients with cardiac implantable electronic devices.
1 citations
References
More filters
TL;DR: This poster presents a probabilistic procedure to determine the best method for selecting a single drug to treat atrial fibrillation-like symptoms in patients with a history of atrialfibrillation.
Abstract: 2015 ESC Guidelines for the Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
2,109 citations
TL;DR: Writing Committee Members Sana M. Al-Khatib, MD, MHS, FACC, FAHA, FHRS (Chair), William G. Stevenson, MD (Vice Chair), and Michael J. Ackerman,MD, PhD,* William J. Page (Chair) are pictured.
557 citations
TL;DR: The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias and detection and conversion of spontaneous episodes.
Abstract: Background—The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation). Methods and Results—This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fib...
481 citations
TL;DR: Complications and inappropriate shock rates were reduced consistently with strategic programming and as operator experience increased, and the S-ICD demonstrated high efficacy for VT/VF.
458 citations
TL;DR: The first large cohort of real-world data from an International patient S-ICD population demonstrates appropriate system performance with clinical event rates and inappropriate shock rates comparable with those reported for conventional ICDs.
Abstract: Aims The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data describing the long-term performance of the S-ICD. This paper presents the first large international patient population collected as part of the EFFORTLESS S-ICD Registry.
Methods and results The EFFORTLESS S-ICD Registry is a non-randomized, standard of care, multicentre Registry designed to collect long-term, system-related, clinical, and patient reported outcome data from S-ICD implanted patients since June 2009. Follow-up data are systematically collected over 60-month post-implant including Quality of Life. The study population of 472 patients of which 241 (51%) were enrolled prospectively has a mean follow-up duration of 558 days (range 13–1342 days, median 498 days), 72% male, mean age of 49 ± 18 years (range 9–88 years), 42% mean left ventricular ejection fraction. Complication-free rates were 97 and 94%, at 30 and 360 days, respectively. Three hundred and seventeen spontaneous episodes were recorded in 85 patients during the follow-up period. Of these episodes, 169 (53%) received therapy, 93 being for Ventricular Tachycardia/Fibrillation (VT/VF). One patient died of recurrent VF and severe bradycardia. Regarding discrete VT/VF episodes, first shock conversion efficacy was 88% with 100% overall successful clinical conversion after a maximum of five shocks. The 360-day inappropriate shock rate was 7% with the vast majority occurring for oversensing (62/73 episodes), primarily of cardiac signals (94% of oversensed episodes).
Conclusion The first large cohort of real-world data from an International patient S-ICD population demonstrates appropriate system performance with clinical event rates and inappropriate shock rates comparable with those reported for conventional ICDs. Clinical trial registration URL: . Unique identifier [NCT01085435][1].
[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01085435&atom=%2Fehj%2F35%2F25%2F1657.atom
416 citations