March 26, 2010 – The first implantations were announced yesterday for a single-chamber implantable cardioverter defibrillator. The system provides physicians with complete diagnostic information not only from the right ventricle, as in regular single-chamber ICDs, but also from the right atrium, including high-resolution online IEGMs.
The additional atrial information can be used for advanced discrimination of supraventricular tachycardias (SVTs) to avoid inappropriate ICD shock therapies and for diagnostic purposes for early detection of atrial arrhythmias, including atrial fibrillation (AF), to reduce the risk of stroke.
After receiving the CE mark, the first Lumax DX Systems were successfully implanted simultaneously at six hospitals across Europe during the third week of March.
The unique Lumax DX System provides patients at risk of sudden cardiac death with a single-chamber ICD system that provides protection and reduces risk.
“The immediate information about atrial arrhythmias, even when asymptomatic, allows me to detect and treat AF early and minimize associated risks such as inappropriate therapies and stroke. Also, I can monitor the success of my AF therapies remotely with Biotronik Home Monitoring and contact the patient whenever needed,” said Dr. Alexander Schirdewan, Charité Campus Benjamin Franklin in Berlin, Germany, and coordinating clinical investigator of the Linoxsmart S DX master study.
Lumax 540 VR-T DX uses the advanced Biotronik Smart Detection algorithm that analyzes the ventricular as well as the atrial heart rate to appropriately discriminate supraventricular tachycardias from ventricular tachycardias and thereby reduce the number of inappropriate therapies, ensuring that a shock is only delivered when absolutely required.
“So far, single-chamber ICDs were limited to ventricular information for the discrimination of SVTs. The SMART algorithm also uses the additional information from the atrium and has proven reliable sensitivity and high specificity in dual-chamber ICDs, and now I can offer this technology to my single-chamber ICD patients too,” said Dr. Antonio Curnis from Spedali Civili in Brescia, professor at the University of Brescia in Italy after the first implantation of the DX system on March 16.
Curnis was the principal investigator of the Italian ADAMO registry that already proved the high sensitivity and specificity of the smart algorithm in a similar Biotronik ICD system.(1)
According to a company press release, Lumax 540 VR-T DX, combined with the fully mobile Biotronik Home Monitoring, is the world’s first and only single-chamber ICD which wirelessly transmits all required patient and device data, including IEGM Online HD for early detection of ventricular and atrial rate disorders and to perform complete remote follow-ups.(2)
Both the Lumax 540 VR-T DX and Linoxsmart S DX rely on proven technology platforms.
For more information: www.biotronik.com
1. "Single Chamber ICD with Single-Pass AV Defibrillation Lead. Outcomes of the ADAMO Italian Registry." PACE 2006; Vol. 29, Supplement 1.
2 N. Varma et al. "Evaluation of efficacy and safety of remote monitoring for ICD follow-up: the TRUST trial." Circulation 2008;118;2309-2317, Abstract 4078.
3 ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation.
4. J. Daubert, W. Zareba, D. Cannom, et al. "Inappropriate implantable cardioverter-defibrillator shocks in MAD IT II: frequency, mechanisms, predictors, and survival impact." Journal of the American College Cardiology 2008;51:1357–65.