Redefining what's possible
SonR is the only weekly self-adjusting CRT optimization system providing optimized timing at rest and during exercise for improved CRT response1
Why do patients need optimizing?
Studies have shown that around one third of patients with advanced heart failure do not effectively respond to CRT.1,2 While there are several causes for this lack of response, suboptimal atrioventricular / interventricular (AV/V V) timing is one of the key factors3
Current methods of optimization are not ideal
Echocardiography based optimization is a very time intensive, costly process and is operator dependent. Previous device based algorithms are equation based and require the patient to come into the hospital, which is time consuming both for the patient and the hospital, incurring costs. Their effectiveness has also been called into question4
Regular optimization is important for your patients, but does it happen enough?
Regular device optimization is important as studies have shown that optimal CRT timings vary over time due to heart remodeling.5
Clinical data suggests that optimization performed at least every three months improves clinical outcomes*6
SonR – Hemodynamic CRT optimization for optimized patient response
SonR uses a unique hemodynamic sensor embedded in the tip of the SonRtip™ atrial sensing/pacing lead. The sensor detects cardiac muscle vibrations that reflect the first heart sound and correlate to left ventricular (LV) contractility7,8
SonR – AV and VV optimization
SonR provides weekly self adjusting optimization of AV and VV delays
• For precise VV configuration, the optimal AV delay is determined on a weekly basis10
• Every week, SonR tests 64 combinations for rest optimization
• Every week, SonR tests 5 combinations for exercise optimization
• By contrast, echo optimization uses far fewer AV delay settings to determine ideal AV and VV delays
SonR performs these individual adjustements under real-life conditions
OPTIMIZES AT REST AND EXERCISE
Optimizing CRT at rest and exercise is important because optimal AV delay changes with patient activity11
• In a study of 23 patients with compensated heart failure, simultaneous biventricular pacing was optimal during exercise in only about 25% of patients11
SonR performs repeated individual optimizations during daily life conditions
• 42 AV/V V delay combinations are tested first to find the optimal rest VV delay
• Then 11 sensed and 11 paced AV delays are tested in combination with the optimal VV delay
• 5 paced or 5 sensed AV/V V delay combinations are tested to establish the optimal exercise AV delay
THE ONLY CRT DEVICE WITH THE POTENTIAL TO IMPROVE RESPONDER RATES4
Promising early results suggest SonR increases responder rates and reduces hospitalizations due to heart Failure12
• In the CLEAR study, 78% of patients in the SonR arm compared with 62% in the standard medical practice arm improved, using the primary composite endpoints of death, heart failure (HF) related hospitalizations, NYHA class and quality of life (QoL)12
• Per protocol analysis showed that significantly more patients in the SonR group than in the control group (91% vs. 75%; p<0.01) were free from secondary endpoint events (death from any cause or hospitalization from HF)12
SonR clinical results suggest improved quality of life12
• From baseline to 1-year follow-up, patients in the SonR group experienced a significant improvement in quality of life (47.4 vs. 67.3; p<0.001)12
• There was a trend indicating an improved quality of life (QoL score increased by more than 10% on the EuroQOL-VAS) in the SonR group compared with the control group (p=0.07)12
SonR signal varies like LVdP/dtmax with VV delay changes6
• SonR measurements correspond to LVdP/dtmax and optimization is carried out on AV and VV delay combinations together, applying each value and measuring corresponding hemodynamics
• Changes in contractility are immediately reflected by the SonR amplitude
• The optimal VV delay corresponds to the highest SonR average amplitude across all AV delays
SonR – AV and VV in combination
SonR CRT optimization is designed to determine optimal AV and VV parameters associated with best LV contractility and best LV filling
• AV and VV delays are interrelated and should not be optimized separately9
• For each VV delay, SonR generates an AV delay curve
• SonR continuously updates any change in optimal AV or VV delay
*CLEAR results obtained through 1st generation SonR
1. Abraham WT, Fisher WG, Smith AL et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002 Jun 13;346(24):18451853.
2. Abraham WT, Gras D, Yu CM et al. Results from the FREEDOM trial – assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy. SP08. Late Breaking Clinical Trials, HRS 2010. Denver, Colorado.
3. Mullens W, Grimm RA, Verga T et al. Insights from a cardiac resynchronization optimization clinic as part of a heart failure disease management program. J Am Coll Cardiol 2009;53:765773.
4. Sorin group, data on file
5. O’Donnell D, Nadurata V, Hamer A et al. Long term variations in optimal programming of cardiac resynchronization therapy devices. Pacing Clin Electrophysiol 2005;28(suppl 1):S2426.
6. Delnoy PP, Klinieken I. Periodic VV and AV delays optimization in cardiac resynchronization therapy improves patients’ clinical outcome: results from the CLEAR study. Heart Rhythm 2010;7(suppl 5):AB27_2.
7. Rickards AF, Bombardini T, Corbucci G et al. An implantable intracardiac accelerometer for monitoring myocardial contractility.The Multicenter PEA Study Group. Pacing Clin Electrophysiol 1996;19:20662071.
8. Bongiorni MG, Soldati E, Arena G et al. Is local myocardial contractility related to endocardial acceleration signals detected by a transvenous pacing lead. Pacing Clin Electrophysiol 1996;19:16821688.9. Sogaard P, Egeblad H, Pedersen AK et al. Sequential Versus Simultaneous Biventricular Resynchronization for Severe Heart Failure : Evaluation by Tissue Doppler Imaging. Circulation 2002;106:20782084.
9. Sogaard P, Egeblad H, Pedersen AK et al. Sequential Versus Simultaneous Biventricular Resynchronization for Severe Heart Failure : Evaluation by Tissue Doppler Imaging. Circulation 2002;106:20782084.
10 Ritter P, Padeletti L, Delnoy PP et al. Device based AV delay optimisation by peak endocardial acceleration in cardiac resynchronisation therapy. Heart Rhythm 2004; 1(suppl 1):377.
11. Bordachar P, Lafi tte S, Reuter S et al. Echocardiographic assessment during exercise of heart failure patients with cardiac resynchronization therapy. Am J Cardiol 2006; 97(11):16221625.
12. Padeletti L. Clinical efficacy of CRT continuous optimization with SonR versus standard clinical practice. HRS 2010;7(suppl 5):AB27_4.
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