Long-term results from the ANSWER randomised clinical trial have shown that Sorin’s SafeR pacing algorithm significantly reduces right ventricular pacing in pacemaker patients and subsequently improves clinical outcomes. The trial results were presented at Cardiostim/EHRA Europace (18-21 June, Nice, France) by Martin Stockburger, Charité University Hospital Berlin, Germany.
Previous studies have shown that unnecessary right ventricular pacing (Vp) has a detrimental effect on the haemodynamic function of the pacemaker patient’s heart. The ANSWER study evaluated whether the minimisation of Vp using the SafeR algorithm improves clinical outcomes for dual chamber pacemaker patients implanted for sinus node disease or for atrio-ventricular block.
The percentage of Vp at one-year follow-up, the first primary endpoint, was significantly reduced in SafeR mode compared to a standard dual chamber pacing (DDD) mode (4.8% vs. 95.4%, p<0.001). This reduction was maintained after three years (11.5% vs. 93.6%, p<0.001). SafeR significantly reduced Vp in sinus node disease patients as well as in atrio-ventricular block patients without generating additional adverse events.
The second primary endpoint, the number of patients hospitalised for atrial fibrillation or heart failure, was not significantly different between the two groups (p=0.33). Nevertheless, the ANSWER study showed a significant reduction of heart failure events; the SafeR mode provided a 51% relative risk reduction of cardiac death or heart failure hospitalisation (p=0.02).
“As the principal investigator of the ANSWER study, I am very pleased with the long-term results which show that SafeR reduces the risk of heart failure hospitalisations and cardiac death. This is important for individual patients and has the potential to provide financial benefit for the healthcare system,” comments Stockburger.
“Sorin Group has a long tradition of developing technologies that aim at improving patient outcomes. In our latest generation of Kora 100 pacemakers, SafeR is part of a suite of solutions designed to manage cardiovascular co-morbidities proactively. The ANSWER study confirms that the unprecedented reduction in right ventricular pacing leads to better patient outcomes,” says Stefano Di Lullo, president, Cardiac Rhythm Management, Sorin Group.