ANSWER Study Shows That SafeR(TM) Safely Reduces Right Ventricular Pacing in Pacemaker Patients and Subsequently Improves Clinical Outcomes

Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced the results of the ANSWER clinical study. The trial results were presented at CARDIOSTIM 2014 Annual Scientific Sessions, in Nice, France, by Dr. Martin Stockburger, Charité University Hospital Berlin, Germany.

Previous studies have shown that unnecessary right ventricular pacing (Vp) has a detrimental effect on the hemodynamic function of the pacemaker patient’s heart. The ANSWER study evaluated whether the minimization of Vp using the SafeR algorithm improves clinical outcomes for dual chamber pacemaker (PM) patients implanted for sinus node disease (SND) or for atrio-ventricular block (AVB).

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 SND patients as well as in AVB patients without generating additional adverse events.

The second primary endpoint, the number of patients hospitalized for atrial fibrillation (AF) or heart failure (HF), was not significantly different between the two groups (p=0.33). Nevertheless, the ANSWER study showed a significant reduction of HF events; the SafeR mode provided a 51% relative risk reduction of cardiac death or HF hospitalization (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 hospitalizations and cardiac death. This is important for individual patients and has the potential to provide financial benefit for the healthcare system,” commented Dr. Stockburger.

"Sorin Group has a long tradition of developing technologies that aim at improving patient outcomes. In our latest generation of KORA^TM 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, "said Stefano Di Lullo, President Cardiac Rhythm Management, Sorin Group.

About the ANSWER study

ANSWER is a multicenter, international controlled randomized trial with three-year follow-up that involved 44 European centers in seven countries. One month after enrollment, patients (n=650) were randomized to either the SafeR mode (n=314) or the DDD mode (n=318) (i.e., without minimized ventricular pacing) over a three-year period.

The following results were released:

• SafeR significantly reduced Vp compared with the DDD mode (11.5% vs. 93.6%, p<0.001), even after three years. Vp was reduced in SND patients as well as in AVB patients.
• 12.4% of patients in the SafeR group were hospitalized for AF or HF, compared to 15.1% in the DDD group (primary endpoint). This difference was not significant (p=0.33). Further analyses on the impact of SafeR on hospitalizations for other cardiovascular events will be performed.
• The time to first occurrence of either cardiac death or hospitalization for HF was significantly prolonged with SafeR vs. the DDD mode, up to three years after implant. A 51% risk reduction of HF events was observed with SafeR vs. DDD (HR=0.49, p=0.02).

About SafeR pacing mode

The SafeR algorithm was developed to manage sinus node dysfunction as well as all types of atrio-ventricular blocks (types I, II and III) and eliminate unnecessary ventricular pacing (Vp) at rest and exercise by combining the benefits of AAI and DDD pacing¹. This signature feature is present in all Sorin pacemakers and ICDs, including the latest generation of KORA 100 MRI conditional pacemakers that focus on the proactive management of co-morbidities.

About Sorin Group

Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). Every year, over one million patients are treated with Sorin Group devices in more than 100 countries.

For more information, please visit www.sorin.com

References:
1. Davy JM et al. Pacing clin electrophysiol 2012; 35(4): 392–402