Redefining what's possible

Why do patients needs optimizing?
Studies have shown that around one third of patients with advanced heart failure do not effectively respond to CRT.^1,2 There are several causes for this lack of response with suboptimal atrioventricular / interventricular (AV/V V) timing being 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. There is also a question over their effectiveness⁴
 
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 –WEEKLY OPTIMIZATION

SonR provides weekly self adjusting optimization of AV and VV delays
• For the optimal VV configuration, the optimal AV delay is determined on a weekly basis⁷
• 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 optimize AV and VV delays

SonR performs repeated individual optimizations during daily life conditions

 
SonR - OPTIMIZES AT REST AND EXERCISE

Optimizing CRT at rest and exercise is important because optimal AV delay changes with patient activity⁸
• In a study of 23 patients with compensated heart failure, simultaneous biventricular pacing was optimal during exercise in only about 25% of patients⁸
 

SonR performs repeated individual optimizations during daily life conditions 
At rest:
• 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
 
During exercise:
• 5 paced or 5 sensed AV/V V delay combinations are tested to establish the optimal exercise AV delay

SonR - THE ONLY CRT DEVICE WITH THE POTENTIAL TO IMPROVE RESPONDER RATES⁴

Promising early results suggest SonR increases responder rates and reduces heart failure hospitalizations⁹
• 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)⁹
• 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)⁹
 

SonR clinical results suggest improved quality of life⁹
• 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)⁹
• There was a trend for 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)⁹
 

SonR signal varies like LVdP/dt_max with VV delay changes⁶
• SonR measurements correspond to LVdP/dt_max 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

Resynchronization for active patients
Exercise training is recommended for all stable chronic HF patients
• “Exercise training leads to further improvements in exercise capacity, hemodynamic measures and quality of life in addition to the improvements seen after CRT”¹³
• Slow VT is present in 30% of ICD recipients¹⁴

Let your patients exercise at rates in the slow VT zone with BTO^TM
• BTO ensures pacing at an appropriate pacing rate while offering unmatched accuracy for rhythm discrimination from slow VTs to VF^{11, 14}
 
Electronically avoid phrenic nerve stimulation
PARADYM™ RF SonR features three programmable left ventricular (LV) vectors
• LV tip to right ventricular (RV) ring
• LV tip to LV ring
• LV ring to RV coil
 

Fewest inappropriate shocks delivered

Protect patients with PARAD+^TM
• PARAD+ provides superior discrimination with 99% specificity in discriminating Supra Ventricular Tachycardia
(SVT) from Ventricular Tachycardia (VT)10
• PARAD+ is the only discriminator to include R-R long cycle search to distinguish stable, rapidly conducted
Atrial Fibrillation (AF) from VT
• PARAD+ is the only discriminator that can identify the chamber of arrhythmia origin to discriminate 1:1
Atrial Tachycardia (AT) from VT
 
Clinically proven
• “Using the PARAD+ discrimination algorithm, the absolute patient risk of experiencing an inappropriate shock was 5%, the lowest recorded thus far”11
 
Appropriate therapy for individual arrhythmias
• If properly identified most VTs can be treated painlessly12
• PARADYM™ RF SonR painlessly treats a broad range of VT from 100 bpm – 255 bpm
 
PARADYM RF SonR accurately discriminates VT in all therapy zones
• PARAD+ in slow VT and VT zones prevents inappropriate shocks by discriminating against SVT
• BTO (Brady-Tachy Overlap) with PARAD+ in the slow VT zone allows treatment of VT as slow as 100 bpm without limiting pacing (up to 145 bpm)
• Stability in the Ventricular Fibrillation (VF) zone allows the most appropriate therapy to be delivered:
Anti-Tachycardia Pacing (ATP) for FVT, only delivering necessary shocks for unstable VT or VF

Thin, Powerful, Long-lasting
Optimal combination of size, power and longevity
• THIN – 11 mm for exceptional comfort
• POWERFUL – 42 J, 37 J delivered
• LONG LASTING – 6.1 Y battery life

Monitored Performance
Enabled for SMARTVIEW^TM remote monitoring
• Easy to use for patients and physicians
• Daily alert monitoring and scheduled follow-up
• Supported by dedicated help desk

*CLEAR results obtained through 1st generation SonR
 
References:
1. Abraham WT, Fisher WG, Smith AL et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002;346(24):1845-1853.
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;53:765-773.
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):S24-6.
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. 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.
8. 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):1622-1625.
9. Padeletti L. Clinical efficacy of CRT continuous optimization with SonR versus standard clinical practice. HRS 2010;7(suppl 5):AB27_4.
10. Hintringer F, Deibl M, Berger T, Pachinger O, Roithinger FX. Comparison of the Specificity of Implantable Dual Chamber Defibrillator Detection Algorithms. PACE 2004;27:976-82.
11. Anselme F, Mletzko R, Bowes R, et al. Prevention of inappropriate shocks in ICD recipients: a review of 10,000 tachycardia episodes. PACE 2007;30:S128-S133. Study made using dual chamber ICDs with standard dual-chamber arrhythmia classification algorithms.
12. Wathen S. et al. PainFREE Rx II. Circulation. 2004;110:2591-2596.
13. Patwala AY, Woods PR, Sharp L, Goldspink DF, Tan LB, Wright DJ. Maximizing Patient Benefit from Cardiac Resynchronization Therapy with the Addition of Structured Exercise Training: A Randomized Controlled Study. J Am Coll Cardiol 2009;53:2332-2339.
14. Sadoul N, Mletzko R, Anselme F et al. Incidence and Clinical Relevance of Slow Ventricular Tachycardia in Implantable Cardioverter-Defibrillator Recipients: An International Multicenter Prospective Study. Circulation 2005;112:946-953.

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