ABSTRACT
In Italy, a strict lockdown was imposed from 8 March 2020 to stop the spread of the coronavirus disease 2019 (COVID-19). We explored the effect of this lockdown on data transmitted by remote monitoring (RM) of implantable cardioverter and cardiac resynchronization therapy defibrillators (ICDs/CRT-Ds). RM daily transmissions from ICDs and CRT-Ds were analyzed and compared in two consecutive 1 month frames pre and post-lockdown: period I (7 February-7 March 2020) and period II (8 March-7 April 2020). The study cohort included 180 patients (81.1% male, 63.3% ICDs and 36.7% CRT-Ds) with a median age of 70 (interquartile range 62-78) years. The median value of physical activity provided by accelerometric sensors showed a significant reduction between period I and II [13.1% (8.2-18.1%) versus 9.4% (6.3-13.8%), p < 0.001]. Eighty nine % of patients decreased their activity, for 43.3% the relative reduction was ≥ 25%. The mean heart rate decreased significantly [69.2 (63.8-75.6) bpm vs 67.9 (62.7-75.3) bpm, p < 0.001], but with greater reduction (≈3 beats/minute) in patients aged < 70 years. Resting heart rate and thoracic impedance showed minor variations. No differences were observed in device pacing % and arrhythmias. In cardiac patients, the lockdown imposed to contain COVID-19 outbreak significantly reduced the amount of physical activity and the mean heart rate. These side effects of in-home confinement quarantine should be taken in consideration for frail patients.
Subject(s)
Arrhythmias, Cardiac/therapy , COVID-19 , Cardiac Resynchronization Therapy Devices , Cardiac Resynchronization Therapy , Defibrillators, Implantable , Electric Countershock/instrumentation , Remote Sensing Technology , Actigraphy , Aged , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/physiopathology , Cardiac Resynchronization Therapy/adverse effects , Electric Countershock/adverse effects , Exercise , Female , Health Status , Heart Rate , Humans , Italy , Male , Middle Aged , Predictive Value of Tests , Remote Sensing Technology/instrumentation , Retrospective Studies , Time FactorsABSTRACT
The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy were being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This article describes the revised trial and the scientific rationale for the specific changes in the protocol.