Kirsten M. Kooiman

Rationale and design of the PRAETORIAN trial: A Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy

BACKGROUND Implantable cardioverter-defibrillators (ICDs) are widely used to prevent fatal outcomes associated with life-threatening arrhythmic episodes in a variety of cardiac diseases. These ICDs rely on transvenous leads for cardiac sensing and defibrillation. A new entirely subcutaneous ICD overcomes problems associated with transvenous leads. However, the role of the subcutaneous ICD as an adjunctive or primary therapy in patients at risk for sudden cardiac death is unclear. STUDY DESIGN The PRAETORIAN trial is an investigator-initiated, randomized, controlled, multicenter, prospective 2-arm trial that outlines the advantages and disadvantages of the subcutaneous ICD. Patients with a class I or IIa indication for ICD therapy without an indication for bradypacing or tachypacing are included. A total of 700 patients are randomized to either the subcutaneous or transvenous ICD (1:1). The study is powered to claim noninferiority of the subcutaneous ICD with respect to the composite primary endpoint of inappropriate shocks and ICD-related complications. After noninferiority is established, statistical analysis is done for potential superiority. Secondary endpoint comparisons of shock efficacy and patient mortality are also made. CONCLUSION The PRAETORIAN trial is a randomized trial that aims to gain scientific evidence for the use of the subcutaneous ICD compared with the transvenous ICD in a population of patients with conventional ICD with respect to major ICD-related adverse events. This trial is registered at ClinicalTrials.gov with trial ID NCT01296022.

Which patients are not suitable for a subcutaneous ICD: incidence and predictors of failed QRS-T-wave morphology screening.

The subcutaneous cardioverter‐defibrillator (S‐ICD) relies on a pre‐implantation QRS‐T morphology screening (TMS) of the ECG to assure that it reliably detects the QRS complexes and T waves. The prevalence and clinical characteristics of the patients who fail this TMS is unknown.

Inappropriate subcutaneous implantable cardioverter-defibrillator shocks due to T-wave oversensing can be prevented: implications for management.

BACKGROUND Inappropriate shocks (IASs) complicate implantable cardioverter-defibrillator (ICD) therapy. The management of IASs in patients with a subcutaneous ICD (S-ICD) differs from that in patients with a conventional ICD because of different sensing algorithms and programming options. OBJECTIVE To describe the management of IASs in patients with an S-ICD. METHODS Patients were implanted with an S-ICD between February 2009 and July 2012. The prevalence data and clinical determinants of IASs were prospectively collected. In the case of T-wave oversensing (TWOS), an exercise test was performed, and all possible sensing vectors were screened for TWOS. The absence of TWOS defined a suitable vector. RESULTS Eleven of 69 patients (54% men; mean age 39 ± 14 years; 73% primary prevention) received IASs after 8.9 ± 10 months of implantation (10.8% annual incidence rate). In 8 cases, TWOS caused IASs. Seven of these IASs occurred during exercise and 1 during atrial fibrillation with a high ventricular rate. To manage TWOS, in 7 of 8 patients the sensing vector was changed and in 5 of 8 patients the (un)conditional zone was changed. Hereafter, IASs recurred in 3 of 8 patients, in 2 because of programming errors. Hence, after reprogramming, we observed no IASs in 87.5% of the patients with TWOS during a follow-up of 14.1 ± 13 months. CONCLUSIONS IASs due to TWOS in the S-ICD can be managed by reprogramming the sensing vector and/or the therapy zones of the device using a template acquired during exercise. Exercise-optimized programming can reduce future IASs, and standard exercise testing shortly after the implantation of an S-ICD may be considered in patients at an increased risk for TWOS.

Communicating Antitachycardia Pacing-Enabled Leadless Pacemaker and Subcutaneous Implantable Defibrillator

Transvenous lead-related complications occur throughout the spectrum of cardiac rhythm management device therapies [(1)][1]. These complications incur significant cost to the health care system and have tremendous impact on patient quality of life. The subcutaneous implantable-cardioverter

Predictors and Permanency of Cardiac Conduction Disorders and Necessity of Pacing after Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) with the Medtronic‐CoreValve bioprosthesis (CoreValve Inc., Irvine, CA, USA) is associated with a high incidence of new‐onset left bundle branch block (LBBB) and cardiac conduction disorders (CCDs) requiring permanent pacemaker (PPM) implantation. Our objective was to investigate the predictors and permanency of CCDs after TAVI and specifically to evaluate the necessity for pacing.

A leadless solution

A 78-year-old male with a history of complicated diabetes, peripheral arterial and coronary disease, hypertension, and atrial fibrillation with a VVI pacemaker was referred to our tertiary centre with a bilateral pocket infection. Management of this infection was suboptimal and not according to the current guidelines. The initial left-sided …