PROVIDING HOPE WHEN HOPE IS LOST
Help Your Patients Find Hope for Living Better with Heart Failure Using Optimizer® Smart
Not all patients suffering from chronic heart failure (CHF) continue to benefit from drugs or have yet become sick enough to qualify for devices including ICDs and CRTDs. Impulse Dynamics has developed the Optimizer® Smart system with CCMTM (Cardiac Contractility Modulation) technology to ease the symptoms of CHF for these patients. CCM therapy delivers precisely timed electrical pulses to the heart cells during a special period of the beating cycle (called the absolute refractory period, or the period just after the heart contracts). In doing so, it strengthens and helps the heart contract more forcibly, thereby delivering more blood and oxygen to the body. Studies have shown CCM therapy to improve 6-minute hall walk distance, quality of life and functional status among patients who are candidates for the device.
Impulse Dynamics has successfully completed three major clinical studies, the results of which have been published in leading medical journals. The European studies suggest that theCardiac Contractility Modulationtherapy is safe and performs as intended in the treatment of heart failure patients. Safety and effectiveness of the Optimizer system is still under study in the US. The Optimizer® system, in its previous versions, has been implanted in over 3,000 patients to date, and has accumulated over 10 years of follow up data. Randomized clinical trials show improved patient performance and quality of life.
FIX-HF-5 Pivotal Trial (US) – a multi-center, randomized study
This study included 428 patients with NYHA Class III or IV symptoms and EF ≤35% who were randomized to receive either an Optimizer® III System implant plus Optimal Medical Management (OMM, n=215) or OMM alone (n=213). The primary safety endpoint was a comparison between groups of the composite of all-cause mortality and all-cause hospitalization (in a non-inferiority analysis) through one year of treatment; this endpoint was reached.
In the overall population, Cardiac Contractility Modulation improved peak VO2, quality of life (indexed by MLWHFQ) and NYHA but not anaerobic threshold (the study’s primary endpoint). Furthermore, in a pre-specified subgroup analysis consisting of about 50% of the overall population characterized by baseline EF ≥25% and NYHA III symptoms, the therapy improved anaerobic threshold, peak VO2, MLWHFQ and NYHA by statistically significant amounts (Figure below).
Presented as late breaking clinical trial at American College of Cardiology annual meeting, March 2008, in Chicago.
See also Kadish et al., American Heart Journal 2011,161:329-337.
FIX-CHF-4 (Europe) – a multi-center, randomized, double blind study
164 subjects with EF ≤35% and NYHA Class II (24%) or III (76%) symptoms received a Cardiac Contractility Modulation pulse generator (Optimizer® III). Patients were randomly assigned to Group 1 (n=80, Cardiac Contractility Modulation treatment first 3 months, sham treatment for following 3 months) or Group 2 (n=84, sham treatment first 3 months, Cardiac Contractility Modulation treatment for consecutive 3 months). Data from therapy ON periods were pooled between the groups and data from therapy OFF periods were pooled between groups. Cardiac Contractility Modulation increased peak VO2 by 0.52±1.39 ml/kg/min (p=0.03) and improved Minnesota Living with Heart Failure Questionnaire (MLWHFQ) by -3 units (p=0.03)(Figure below). Overall, in patients with chronic heart failure and left ventricular dysfunction, Cardiac Contractility Modulation signals improved exercise tolerance and quality of life with as little as 3-months of treatment.
Retrospective Studies Show Sustained Long Term Benefit of Cardiac Contractility Modulation Therapy
Multiple investigators initiated retrospective reports related to the long-term benefit of the therapy. A study on 81 CHF patients (J. Kuschyk, et al. International Journal of Cardiology 2015 (183C)) (NYHA II-IV, reduced EF) showed significant improvement by Cardiac Contractility Modulation during a mean follow-up period of 34 months (ranging 6-123 months). The cohort had significant long-term improvement in left ventricular size and function, quality of life, NYHA class, peak VO2 and decreased levels of NT-proBNP. Nearly 75 % of the patients had an improvement of at least one NYHA class even after long-term follow-up. Importantly, compared with the per patient mortality risk score (calculated by the MAGGIC model), the long-term results indicated that long-term survival with Cardiac Contractility Modulation was better than expected (p=0.022).
Another study of 68 CHF patients (A. Kloppe et al. International Journal of Cardiology 209 (2016) 291–295) (NYHA II-III, narrow QRS) treated by Cardiac Contractility Modulation during a mean follow-up period of 4,5 years (up to 10 years) showed that compared with the per patient mortality risk score (calculated by the SHFM), the survival with Cardiac Contractility Modulation was better than expected (p=0,007)
The study by Liu M et al. (International Journal of Cardiology 206 (2016) 122–126) on 41 CHF patients (NYHA III) reported reduced all-cause mortality, cardiovascular mortality and hospitalization rate for patients with EV 25-40% in up to 96 months of observation.
Kaplan-Maier analysis for all-cause mortality hospitalizations and cardiovascular mortality.
Liu M et al. International Journal of Cardiology 206 (2016) 122–126
The Optimizer® Smart system has been implanted in over 4,000 patients, accumulating over 10 years of follow-up datavia ongoing post approval registries.
Additional studies are underway in the US and worldwide to further elucidate the applicability of CCMTM therapy.
We also provide a patient-centered approach to deliver hands-on assistance for providers seeking prior authorizations and appeals with insurance carriers.
About the Optimizer® Smart System
The Optimizer® Smart is a minimally invasive, implantable device that delivers a proprietary therapy called CCM to patients with heart failure. CCM (cardiac contractility modulation) is a first-of-a-kind, life-changing treatment alternative for a vast population of heart failure patients who remain symptomatic despite guideline-directed medical therapy and are not yet sick enough for a heart pump.
The Optimizer® Smart System includes an implantable stimulation device (similar in size to a pacemaker) and an external charging station.
CCM therapy delivers precisely timed electrical pulses to the heart cells during a special period of the beating cycle (called the absolute refractory period, or the period just after the heart contracts). In doing so, it strengthens and helps the heart contract more forcibly, thereby delivering more blood and oxygen to the body. Evidence from clinical investigations proves that CCM therapy is able to improve the heart’s contractility by modifying the function and expression of proteins in the heart muscle thus improving the overall function of the heart.
The Optimizer® Smart Procedure
The device is implanted in a small pocket under the skin of the upper chest, along with commercially available pacemaker leads that are placed in the heart’s right ventricular septum, while the patient is under light sedation. The device is generally implanted in the right pectoral region into a subcutaneous pocket at a depth of 2.5 centimeters and the pocket is then closed. After implantation, the physician custom-programs and activates the device for the patient. The patient charges the device one hour per week using the external charger. Optimizer® Smart systems are expected to last for at least 15 years before requiring replacement.