Limitations of traditional implants
Implant complications
•Vascular injury
•Cardiac perforation
•Pneumothorax
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Longer term complications
•Venous obstruction
•Lead failure
•Infection (could lead to bacteremia or endocarditis)
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NEED FOR ALTERNATIVE OPTIONS
Leadless Pacemakers
SJM/Abbott Nanostim trials 2014 & 2015
•issues with premature battery depletion & spontaneous detachment of the docking button.
•Higher dislodgement rates compared to micra.
•Implants halted in 2016 due to high complication issues
MDT Micra VR
•FDA 2016
MDT Micra AV dual leadless PPM
•FDA 2020 (MARVEL 2 trial)
•VDD – atrial sensing only
Abbott Aveir dual chamber leadless PPM
•FDA 2023
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Subcutaneous ICDs
Boston Scientific Emblem
•2002 – proof of concept
•2009 EU approval
•2012 US approval
•2015 2nd generation – increased longevity & smaller size with HM
•2016 3rd gen – more sophisticated algorithms, MR compatible
•No ATP available
Passive fixation outside rib cage
Extravascular implantable cardioverter defibrillator
•Only recently approved in Australia (2024)
•Same size as standard ICD
•40J shock
•Passive fixation within the substernal space
•2 pace/sense electrodes (ATP)
•2 defibrillation coils
•3 sensing vectors
•3 pacing vectors
Cautions
•small R waves (>1mV is satisfactory)
•large fluctuations in R wave with position
•frequent noise episodes (muscle/movement artefact) - if sustained noise episodes device should store as a VOS episode and withhold therapies
Endocardial leadless LV leads
EBR Systems
•*WISE CRT system not TGA approved in Australia and not included on the ARTG*
•WiSE CRT trials 2014Â
•SELECT LV trial 2017
•1st implant in Australia in 2018
•Delivers ultrasonic energy from a transmitted (lateral implant) to LV endocardial receiver (size of grain of rice)
