Defibrillation leads remain the weak point of implantable cardioverter-defibrillators due to potential lead failure that may result in adverse patient outcomes. Thus, modern defibrillation leads that are safe, efficacious, and reliable are needed. The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the novel, lumenless, catheter-delivered, small-diameter (4.7Fr), OmniaSecure defibrillation lead designed for reliability and targeted placement, based on the established SelectSecure SureScan MRI Model 3830 pacing lead. The trial exceeded primary safety and efficacy objective performance goals, demonstrating favorable safety and efficacy profile as well as zero lead fractures through ~1 year follow-up; patients remain in follow-up. To report ongoing safety, efficacy, and reliability of the OmniaSecure defibrillation lead based on midterm LEADR trial results. This pivotal trial enrolled patients with guideline-directed indications for de novo primary or secondary prevention ICD/CRT-D. Safety is assessed through freedom from RV-lead related major complications via Kaplan-Meier, efficacy is assessed as ambulatory therapy efficacy (shock and ATP) during all available device data follow-up, and reliability is assessed through electricals and fracture-free performance of the OmniaSecure lead. The rates of appropriate and inappropriate therapy were also determined via Kaplan-Meier. In total, 643/657 patients were successfully implanted with the OmniaSecure defibrillation lead in the standard RV location (26% female; 61.9 ± 12.9 years); midterm follow-up time of 18.2 ± 5.5 months. Freedom from RV-lead related major complications was 97.1% at 12 months and 96.9% at 24 months (Figure 1); presently there has been 1 RV-lead related major complication after 12 months. Among the 670 spontaneous episodes that received appropriate therapy, there was a 96.2% (127/132) successful shock termination/slowing of rhythm by shock to be ATP terminated with the remainder self-terminated or in context of storm or other patient factors. ATP efficacy was 76.5% (485/634 episodes), with ATP preventing shock in 59 patients. Appropriate therapy was delivered in 10.7% of patients by 12 months and 17.6% by 24 months. The inappropriate shock rate was 2.7% at 12 months and 3.8% at 24 months. There have been zero fractures of the OmniaSecure lead through follow-up (17.8±6.0 mo.). Electricals (R-wave amplitude, pacing capture threshold, and pacing impedance) are within expected ranges and stable throughout. There have been no reports of adverse events related to the RV lead associated with tricuspid valve regurgitation. The LEADR trial demonstrates ongoing safety, efficacy, and reliability of the novel, small-diameter OmniaSecure lead, with low complication rates, high ambulatory efficacy, and reliable performance.OmniaSecure lead safety through 24 mo.

AIMS:The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the small-diameter (4.7 Fr), integrated bipolar OmniaSecure defibrillation lead. As previously reported, the trial exceeded primary safety and efficacy objective thresholds, demonstrating favourable performance and zero fractures through ∼12 months follow-up, with patients in ongoing follow-up. Longer-term follow-up of the LEADR trial with emphasis on the sensing and detection capabilities of the OmniaSecure lead is reported here. METHODS AND RESULTS:Patients with indications for de novo implantable cardioverter-defibrillators/cardiac resynchronisation therapy defibrillators were implanted with the OmniaSecure lead in standard right ventricle (RV) locations and followed at pre-specified intervals along with CareLink™ remote monitoring transmissions, where available. Throughout follow-up, the lead was evaluated for safety, efficacy, and reliability along with sensing and detection performance. There were 643/657 (97.9%) patients successfully implanted with the OmniaSecure lead with mean follow-up of 18.2 ± 5.5 months. There was a 96.9% freedom from major study lead-related complications at 24 months. Inappropriate shock rate was 2.7 and 3.8% at 12 and 24 months, respectively. At 24 months, 17.6% of patients received appropriate therapies (shock and/or ATP) with a 76.5% ATP efficacy. There have been zero fractures during follow-up along with chronically stable pacing capture threshold, pacing impedance, and R-wave amplitudes. There were four patients with an adverse event related to PWOS (0.6%), none of which was associated with inappropriate shock. There were four patients with an adverse event related to TWOS (0.6%), of which three patients were associated with inappropriate shock (0.5%). Oversensing was resolved predominantly by programming the RV sensitivity to less sensitive settings. During VF induction at implant, 97.6% (120/123) of patients showed appropriate VF episode detection at the least sensitive setting of 1.2 mV, with the remaining having detection at more sensitive settings. In follow-up, 670 VT/VF episodes were appropriately detected and treated in 94 patients with a variety of RV sensitivities and no reports of under-detected episodes. Moreover, a virtual sensitivity analysis also showed no under-detection across different RV sensitivity programming. CONCLUSION:Chronic sensing performance of the OmniaSecure defibrillation lead demonstrated R-wave stability with a low rate of P-wave and T-wave oversensing, resolved predominantly by adjusting RV sensitivity. Further, VT/VF detection was successful and was not impacted when programmed to less sensitive settings. The OmniaSecure lead shows robust sensing and detection performance and programmability in ongoing follow-up.

BACKGROUND:The LEADR (Lead Evaluation for Defibrillation and Reliability) trial evaluated the small-diameter (4.7F), lumenless, integrated bipolar OmniaSecure defibrillation lead. The trial exceeded primary safety and efficacy objective thresholds, demonstrating favorable efficacy at implant and a low rate of complications. Three-year term outcomes of the LEADR trial assessing the OmniaSecure lead are reported here. METHODS:The LEADR trial is a prospective, multicenter, single-arm clinical trial. Patients with an indication for de novo implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator were implanted with the OmniaSecure lead in standard right ventricle locations and followed at prespecified intervals. The lead was evaluated for safety, efficacy, and reliability through final follow-up. RESULTS:There were 643/657 patients (97.9%) successfully implanted with the OmniaSecure lead with a mean follow-up of 32.4±9.1 months (26% female, 61.9±12.9 years). Pacing capture threshold, pacing impedance, and R-wave amplitudes remained stable throughout. There was a 96.5% freedom from major study lead-related complications at 3 years. At 3 years, 22.3% of patients received appropriate therapies, that is, shock and antitachycardia pacing, with a 75.4% antitachycardia pacing efficacy. Inappropriate shock rate was 2.7% and 5.9% at 1 and 3 years, respectively. CONCLUSIONS:The final results of the LEADR trial demonstrated 3-year term safety, efficacy, and reliability of the OmniaSecure lead, emphasizing the potential utility of this lead in a wide variety of patients.

BACKGROUND:Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure defibrillation lead is a novel, small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform. OBJECTIVE:This trial assessed safety and efficacy of the OmniaSecure defibrillation lead. METHODS:The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead-related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively. RESULTS:In total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead-related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD). CONCLUSION:The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.

Background Defibrillation leads remain the Achilles heel of implantable cardioverter-defibrillators. As patients with implantable cardioverter-defibrillators are living longer and battery longevity increases, more durable leads are needed. The LEADR trial evaluated the novel, lumenless, small-diameter, OmniaSecure defibrillation lead and demonstrated favorable safety and efficacy profile as well as zero fractures through 12.7 ± 4.8 months and remains in clinical follow-up. To augment the clinical trial, advanced cardiac lead reliability modeling was used to project long-term lead durability. Objective We aimed to project the 10-year fracture-free survival of the OmniaSecure defibrillation lead using reliability modeling. Methods The validated reliability model, which incorporates patient and bench test data, was used to project the 10-year fracture-free survival of the OmniaSecure lead. A subset of LEADR trial patients underwent biplane fluoroscopy imaging during cardiac and patient motion to evaluate the lead’s bending curvature in vivo. Bench tests then reproduced these use conditions with greater bending curvatures than observed in patients to exaggerate stress on the lead and to evaluate the lead fatigue strength. Results The reliability modeling projects a 98.2% fracture-free survival rate of the OmniaSecure lead at 10 years, including a 10-year fracture-free survival rate of 97.9% in adolescents, exceeding both the modeled and clinical 10-year performance of the highly reliable, larger diameter Sprint Quattro lead. Conclusion Consistent with early clinical trial experience, modeling projects highly durable 10-year performance of the OmniaSecure lead, including within the active adolescent pediatric population, which may uniquely benefit from a novel 4.7F defibrillation lead designed for reliability. ClinicalTrials.gov identifier NCT04863664

BACKGROUND:Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small-diameter, lumenless, catheter-delivered, defibrillator lead was developed with the aim to improve long-term reliability.METHODS AND RESULTS:The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients may be participating for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled.CONCLUSION:The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.

AbstractBecause of the growing number of implanted cardiac pacemakers and defibrillators and the ever-increasing complexity of these devices a fundamental knowledge of device malfunctions is of utmost importance even for the non-cardiology physician. Apart from hardware problems such as device infection, lead fracture or dislocation, basic knowledge of the pacemaker sensing and pacing algorithms is also necessary in order to judge the stimulation behavior in different clinical settings. With this respect, there are specific problems for antibradycardia and resynchronizing pacemakers as well as implantable defibrillators. This article gives an overview of the most common problems with cardiac pacemakers and defibrillators as well as the differential diagnostic and therapeutic management for the physician without specific training in arrhythmology.

This case highlights the difficulties in pacing lead implantation for transvenous phrenic nerve stimulation to treat central sleep apnea in heart failure. Cannulation of the left pericardiacophrenic vein (PPV) initially failed due to vessel tortuosity. On the basis of sound knowledge of collateral vessels, the inferior phrenic vein (IPV), which drains into the inferior vena cava, was intubated using a guide catheter. A guidewire could be retrogradely advanced via the IPV to the left PPV and brachiocephalic vein. The wire was captured via a snare catheter, such that the heart was held "on a string", thereby providing adequate support for lead placement.

Obwohl Herzschrittmacher und implantierbare Defibrillatoren heute der therapeutische Standard in der Behandlung bradykarder und tachykarder Herzrhythmusstörungen sind, kommt es doch insbesondere durch die transvenösen Stimulations- und Defibrillationselektroden im Langzeitverlauf nicht selten zu Komplikationen wie Elektrodenbruch, Infektionen und Trikuspidalinsuffizienzen. Daher sind in den letzten Jahren sondenlose Herzschrittmacher und rein subkutan implantierbare Kardioverter-Defibrillatoren (S-ICD) entwickelt worden, die ohne transvenöse Elektroden implantiert werden und so die Langzeitkomplikationsrate der Implantate reduzieren sollen. Allerdings sind bisher verfügbare sondenlose Herzschrittmacher auf die einfache 1‑Kammer-Stimulation und der S‑ICD auf einen reinen Defibrillator ohne die Möglichkeit der antibrady- bzw. antitachykarden Stimulation oder kardialen Resynchronisation beschränkt. Daher können diese Geräte nicht als Mehrkammerschrittmacher bzw. -defibrillatoren dienen, obwohl gerade bei diesen aufgrund der Zahl der transvenösen Sonden auch mit mehr Langzeitkomplikationen zu rechnen ist. Der vorliegende Beitrag fasst die aktuelle Datenlage zu den sondenlosen Schrittmachern und S‑ICD zusammen, diskutiert die Limitationen dieser Systeme und gibt einen Ausblick, wohin sich die Therapien entwickeln könnten.

Schlafbezogene Atemstörungen können als obstruktive (OSA) und zentrale Schlafapnoe (CSA) klassifiziert werden. Während für Pathophysiologie, diagnostisches Vorgehen und Therapie bei OSA heute schon weitreichende Erkenntnisse bzw. Empfehlungen vorliegen, ist die Entstehung der CSA noch nicht vollständig verstanden, die Patientenidentifikation oft schwierig und die Notwendigkeit einer spezifischen Therapie umstritten. Die CSA tritt häufig als Begleitsymptom bei Herzinsuffizienz auf und ist mit einer schlechten Prognose assoziiert. Eine optimale Herzinsuffizienztherapie führt zu einer Reduktion der CSA und ist daher von zentraler Bedeutung in der Therapie. Im Gegensatz zur OSA kann durch eine nichtinvasive Beatmungstherapie die Prognose der Patienten mit CSA nicht verbessert werden; unter ASV-Beatmung (adaptive, druckunterstützte Servoventilation) kam es sogar zu einer erhöhten Sterblichkeit. Als neues Therapieverfahren befindet sich die transvenöse Neurostimulation des N. phrenicus über einen implantierbaren Schrittmacher in der klinischen Erprobung. Erste Ergebnisse weisen auf positive Effekte hinsichtlich der Schlafapnoe-Parameter und der Lebensqualität hin, ohne dass es bisher Hinweise auf eine negative Beeinflussung der Mortalität gibt. Allerdings müssen vor einer breiten klinischen Anwendung weitere Studiendaten an größeren Patientenkollektiven abgewartet werden.

Heute gibt es eine Vielzahl verschiedener Herzschrittmacher- und ICD-Systeme für die Behandlung aller bradykarden und der meisten tachykarden Herzrhythmusstörungen. Sie erlauben durch ihre Programmierbarkeit die Anpassung an die spezifischen Bedürfnisse jedes Patienten.

Cardiac pacemakers and implantable cardioverter defibrillators (ICDs) are implanted not only by cardiac surgeons but also increasingly more by cardiologists worldwide. Apart from the basic expertise on the indications for implantation and system selection, it is of utmost importance to have profound knowledge of the underlying anatomy and the surgical techniques involved in device implantation. The surgical technique and the most important aspects of patient preparation, perioperative surveillance, anesthesia, surgical access to the venous system, choice of electrodes and alternative intracardiac sites for electrode placement are described. Moreover, the discussion of various intraoperative and postoperative complications is aimed at helping to find adequate measures for commonly observed situations in the clinical practice.

Herzschrittmacher und Implantierbare-Kardioverter-Defibrillator(ICD)-Systeme werden weltweit nicht nur von Herzchirurgen, sondern zunehmend auch von Kardiologen implantiert. Neben den theoretischen Grundlagen bezüglich Indikation und Systemauswahl sind fundierte Kenntnisse der Anatomie und der spezifischen Operationstechnik gleichermaßen unverzichtbar. Für die OP-Technik werden die wichtigen Aspekte der Patientenvorbereitung, der perioperativen Überwachung und der Betäubungsverfahren ebenso wie die Zugangswege zum Venensystem, die Elektrodenauswahl und alternative intrakardiale Implantationsorte beschrieben. Darüber hinaus soll die Diskussion verschiedener intra- und postoperativer Komplikationen helfen, in der Praxis situationsgerecht zu reagieren.

Introduction: Single chamber leadless pacemakers (PM) are a new alternative to conventional VVI PM eliminating the risk of pocket or lead problems. Currently available systems use either a helical wire screw (Nanostim™, St. Jude Medical) or nitinol tines (Micra™, Medtronic) for endocardial fixation. There is some concern that device retrieval in case of infection or battery depletion may be a problem with these new PM. Data on extraction of leadless PM beyond the immediate postoperative phase are very limited. Methods: Since European market release in June 2015 we successfully implanted Micra PM in 8 pts. (mean age 75.5 yrs. (20 – 92 yrs.); 5 females). Indications for implantation of Micra where bilateral PM pocket infection (n = 1), central vein occlusion or stenosis (n = 3), severe pocket problems (n = 1) or other reasons (n = 3). There were no acute complications in any patient; in 2 pts. up to 3 positions had to be tested to reach adequate sensing and/or pacing threshold. Mean radiation duration was 7,56 + 7,37 min. In one of these pts. the Micra device was explanted after 12 weeks. He received the system due to symptomatic bradyarrhythmia and permanent atrial fibrillation with moderately reduced left ventricular function (LVEF 45%) and planned implant of a phrenic nerve stimulator to treat his central sleep apnea which was successfully performed 3 weeks after the Micra implant. Nine weeks later the pt. was successfully resuscitated from ventricular fibrillation. The patient recovered well and a coronary angiogram after the event showed no new coronary stenoses. The decision was made to extract the leadless VVI PM and exchange it for an implantable defibrillator for secondary prevention of sudden death, combined with cardiac resynchronization therapy (CRT-D) to prevent left ventricular desynchronisation by right ventricular apical pacing. After placement of the ICD lead, a left femoral venous access was used to place a new 23 French (F) introducer system into the right atrium. Using a 8.5 F steerable catheter and a 25 mm snare the Micra pacemaker could be fixed in the neck section of the device and retrieved from endocardial fixation with permanent traction for 18 seconds without any hemodynamic compromise. The whole system could then be retracted into the 23 F sheath and removed without problems. Conclusion: This case report illustrates that retrieval of the Micra leadless PM is possible beyond the immediate postoperative phase by using a femoral approach with a large introducer sheath and a snare catheter, capturing the neck of the PM and using gentle traction (as opposed to “screwing off” with the Nanostim device). It cannot be excluded that retrieval may be more difficult by strong fixation of the Micra nitinol tines and tissue overgrowth years after implant. In this situation, the implantation of an additional leadless PM while leaving the first device in place may be an alternative.

Spezielle Hilfsmittel ermöglichen die transvenöse Extraktion defekter oder infizierter Schrittmacher- und ICD-Elektroden ohne operative Freilegung des Herzens. Das deutlich erhöhte Risiko bei der Extraktion langzeitig implantierter Elektroden erfordert fundierte Kenntnisse des Operateurs und erweiterte personelle Voraussetzungen. Kriterien zur Abschätzung des individuellen Extraktionsrisikos sind neben Alter und Geschlecht das Zeitintervall zwischen Im- und Explantation, Art und Anzahl der Elektroden, Zugangswege bei der Implantation und der Ort der Elektrodenfixation. Während die Extraktion langliegender Elektroden immer unter Einsatz interner Extraktionshilfen (Locking stylets) erfolgt, ist die Verwendung spezieller externer Extraktionshilfen optional. Vor allem der Einsatz eines externen Laser-Sheaths mit hohem Perforationsrisiko sollte nur unter sehr strenger Indikationsstellung erfolgen. Besteht nach Abschätzung der individuellen Faktoren ein sehr hohes Operationsrisiko, muss alternativ eine chirurgische Elektrodenentfernung unter Freilegung des Herzens und Einsatz der extrakorporalen Zirkulation erwogen werden.

Because of the enormous increase in pacemaker and implantable cardioverter-defibrillator (ICD) implants, the number of device-related infections has also increased considerably. In fact, this increase has been out of proportion due to the higher patient age at implant, the increased co-morbidity of patients and the higher complexity of the implanted devices. Apart from few exceptions the infection of a pacemaker or ICD requires complete explantation of the whole system with adjunctive antibiotic therapy. The diagnosis of device infection, the indication and different options for therapy are thoroughly discussed in this article according to the current status of knowledge.