“To have this information in hand provides a greater level of confidence not only for the medical community, but also for the thousands of patients around the world who depend on this device in life-saving procedures.”
In short
Cardiac Pacing and Home Monitoring company, Biotronik has issued a news release about a new publication, suggesting its Closed Loop Stimulation (CLS) pacemakers perform well in a large patient cohort.
Background
Closed Loop Stimulation(CLS) is a unique physiologic technology of rate-adaptive pacing. As we pointed out in our article last week about the baseball hall-of-famer who is fitted with such a device, Biotronik’s is the only sensor system in the world that can trigger changes in heart rate to optimize cardiovascular flow during mental excitement or stress.
CLS integrates into the natural cardiovascular control system and determines the appropriate heart rate based on intracardiac impedance measurements. These measurements reflect changes of the cardiac contraction dynamics in reaction to information coming from the autonomic nervous system.
The study
With 706 patients recruited into this study, it represents the largest-ever clinical investigation of Biotronik CLS pacemakers. The paper, from the Czech Republic, has been been published in European Heart Journal, Europace (European Journal of Pacing, Arrhythmias and CardiacElectrophysiology) and is entitled “Clinical observations with Closed Loop Stimulation pacemakers in a large patient cohort: the CYLOS Routine Documentation Registry (RECORD)” by Michaela Lindovská, MD, et al.
In the study, based at evaluation sites in Germany, Czech Republic, Austria and Hong Kong, clinical investigators from 57 centres graded the technical performance and medical benefit of Biotronik CLS as “excellent” in nearly 80% of the evaluated patients and adequate in 18% with only a few rating it poor for either medical benefit (1.4%) or technical performance (0.5%).
The study abstract can be found here and concludes that Biotronik’s CLS implants demonstrate excellent performance in all pacing sites within the right ventricle (apical, septal, outflow tract), and even in advanced heart failure with no difference to patients without heart failure.
Investigator comments
“RECORD is an extraordinary and extremely important study. The statistics it provides dramatically advances our understanding of the effectiveness of CLS,” said Michaela Lindovská, MD, Cardiology Bulovka, Prague, Czech Republic. “To have this information in hand provides a greater level of confidence not only for the medical community, but also for the thousands of patients around the world who depend on this device in life-saving procedures.”
Source: Biotronik
published: April 4, 2012 in: Biotronik, Cardio, Clinical Studies/Trials