RECORD clinical study confirms Biotronik's closed loop stimulation
30 April 2012
Breakthrough results from more than 700 patients studied in a
clinical investigation of the Biotronik CLS pacemakers have been
published in Europace.
Clinical investigators from 57 study centres graded the technical
performance and medical benefit of Biotronik CLS as "excellent" in
nearly 80% of the evaluated patients, a clear indication of improved
confidence and satisfaction.
A total of 706 patients at evaluation sites in Germany, Czech
Republic, Austria and Hong Kong were studied. Patients treated with
a single- or dual-chamber Biotronik pacemaker were eligible for
enrolment if the CLS mode was activated. Reprogramming of
CLS-related parameters was rarely undertaken: More than 90% of
pacemakers operated with default settings in the long term.
CLS Technology — unique to Biotronik pacemakers — is the only
sensor system in the world that can trigger changes in heart rate in
order to optimize cardiovascular flow not only based on physical
activity, but also based on acute mental excitement or stress.
The RECORD investigation of CLS pacemakers is the largest to date
and demonstrates 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
"RECORD is an extraordinary and extremely important study. The
statistics it provides dramatically advances our understanding of
the effectiveness of CLS," said Michaela Lindovska, 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."
About Closed Loop Stimulation (CLS)
CLS is a unique physiologic technology of rate-adaptive pacing.
It 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. CLS is available for selected
Biotronik pacemakers, including ones featuring the original
Biotronik Home Monitoring service.
Michaela Lindovska, MD, et al. Clinical observations
with Closed Loop Stimulation pacemakers in a large patient cohort:
the CYLOS Routine Documentation Registry (RECORD).