Implantable Cardiac Defibrillator
Implantable Cardiac Defibrillators (ICDs) are used to prevent sudden cardiac death in individuals who experience abnormally fast heart rates. According to the American Heart Association, studies have shown that ICDs have a role in preventing cardiac arrest in patients with certain risk factors or with known, sustained ventricular tachycardia (unusually fast heartbeat) or fibrillation (quivering or irregular heartbeat). Nearly 70,000 new patients are implanted with an ICD each year in the U.S.
The ICD is usually implanted in the upper chest and the device is connected to the heart with thin, flexible wires, called leads. If the ICD and leads detect an abnormal heart rhythm – either beating chaotically or too fast – the device will deliver an electric shock through the leads directly to the heart to restore a normal heartbeat. ICDs can be an effective therapy in preventing sudden cardiac death for those patients who are at risk for life-threatening ventricular arrhythmias.
What is DX technology?
The DX System provides dual-chamber diagnostic capabilities with a single lead, which reduces risks associated with additional hardware for patients while providing valuable clinical information to the physician. BIOTRONIK’s DX technology provides sophisticated atrial signal processing capabilities in order to better detect atrial fibrillation and reduce risk of inappropriate shocks from an ICD.
What are the advantages of DX technology for patients?
The DX system provides patients with access to the benefits of both dual-chamber and single- chamber ICDs in a single-lead device.
Many patients in the U.S. who receive a two-lead or “dual-chamber” ICD receive that system because the atrial information from the additional lead provides useful information to help the physician manage the patient’s condition. However, dual-chamber systems are associated with higher complication and in-hospital mortality rates. For the patients who receive one-lead, or “single-chamber” systems, the physician may select the system because of its lower risk profile. However, as a result, the physician will not have the benefit of the atrial information, which can limit their ability to track important information such as the onset of atrial fibrillation.
What are the risks associated with additional leads/hardware?
Peer-reviewed studies show that the risk of infection and implant-related mortality and morbidity (although relatively low) are twice as high with dual-chamber compared to single- chamber devices. In addition, the risk of infection increases with the number of leads. In some cases, leads may have to be extracted, a procedure that may expose the patient to significant risk, possibly even death.
What are the limitations of single-chamber devices?
Single-chamber devices are designed only to sense changes in ventricular rhythm and are unable to sense atrial arrhythmias, such as atrial fibrillation (AF). Additionally, and importantly, they are unable to provide valuable atrial information that aids in the accurate diagnosis of a patient’s condition. This can result in an increased risk of an inappropriate shock, or potentially a stroke if AF is not detected and treated.
What differentiates the Inventra DX from other ICD systems?
The Inventra DX is the only ICD that can deliver ultra-high energy on the first shock and offers better protection to patients that depend on this life-saving therapy. The Inventra DX is capable of delivering 42 joules on the first shock, which physicians may choose for patients who present with high defibrillation thresholds that require maximum energy. The device also has a longer battery life to reduce the need for more change-outs.
How is the Itrevia DX different from other ICD systems?
The Itrevia DX is a less invasive therapy with an algorithm that can identify successful pain free therapies for each patient and dynamically re-apply them as needed. The complete Itrevia family – including Itrevia VR-T, Itrevia DR-T and Itrevia HF-T – were recently FDA approved.