Modular Communicative Leadless ICD Proves Safe and Exceeds Performance Expectations

An implantable cardioverter-defibrillator (ICD) is commonly used in patients at risk of life-threatening cardiac arrhythmias. This device can interrupt arrhythmias in two primary ways. Firstly, it can administer one or more electric shocks, which are often painful if the patient is conscious. Secondly, it can emit a series of rapid pulses through a wire in the heart, a method not felt by patients due to the lower intensity of the pulses. However, not all ICDs offer this second type of therapy, and even when they do, the wire can cause complications like detachment and infections.

These issues have spurred the development of a completely wireless alternative. Wireless ICDs avoid the complications associated with traditional wired systems but have been unsuitable for patients with certain conditions like ventricular tachycardia, where the heart beats too fast, or bradycardia, where the resting heart rate is abnormally slow. Now, new research has shown that the first wireless modular system is safe and meets the needs of these patient groups, surpassing performance expectations and paving the way for broader adoption.

In 2021, Amsterdam UMC (Amsterdam, Netherlands) became the first in Europe to implant a wireless pacemaker that communicates with a subcutaneous ICD as part of the initial phase of the global Modular ATP study. This study, involving nearly 300 patients across 38 hospitals in Europe and North America, recorded zero incidents of pacing failure due to communication breakdowns. Amsterdam UMC collaborated with other academic institutions and Boston Scientific (Marlborough, MA, USA) to develop this technology, which not only fulfilled but exceeded performance expectations.

"It is the first system in which medical devices, which are implanted separately in the body, are in contact with each other and work together. Its development will reduce the number of complications and invasive procedures all while maintaining patient safety," said Reinoud Knops, cardiologist at Amsterdam UMC and leader of the study. "We aimed for the two wireless parts communicating successfully in 88% of the attempts but this turned out to be a lot higher, with a success rate of almost 99%."

"If the ICD detects a cardiac arrhythmia, it sends a signal to the pacemaker to deliver the pulses. If the arrhythmia persists, the ICD will still give a shock. As a result of this fine-tuning process, the patient will receive an electric shock less often," added Knops.

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