RECORD study shows efficacy and safety for Biotronik Closed Loop Stimulation (CLS) pacemaker therapy


Michaela Lindovská and colleagues have recently published breakthrough results from more than 700 patients studied in the largest-ever clinical investigation (RECORD study) of Biotronik closed loop stimulation (CLS) pacemakers.

According to a company release, the closed loop stimulation technology, which is unique to Biotronik pacemakers, is the only sensor system in the world that can trigger changes in heart rate in order to optimise cardiovascular flow not only based on physical activity, but also based on acute mental excitement or stress.

Under routine clinical conditions, 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 full 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.

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 failure.

“RECORD is an extraordinary and extremely important study. The statistics it provides dramatically advances our understanding of the effectiveness of CLS,” said Michaela Lindovská, 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.”