Advanced Heart Failure (HF) represents a significant and growing burden in all developed countries. Approximately 12.7 million patients are affected in the US and in Western Europe, and 4.1 million or 32% of these are classified as NYHA Class III and IV (significant limitation of physical activity). The financial burden is growing dramatically with an estimate of direct and indirect costs to more than double from $31 billion in 2012 to $70 billion in 2030 in the US alone. The number of people with heart failure could climb 46% from just over 5 million in 2012 to 8 million in 2030 in the US. Hospitalization – more than 1.1 million patients a year - accounts for two thirds of the cost. This alarming rise in incidence and cost is fueled by the ageing population, prevalence, increase in number of patients with hypertension and diabetes, increases in number of people who smoke and increased hospitalizations
One of the most prevalent forms of chronic heart failure (CHF) is dilated cardiomyopathy (DCM) that occurs when the heart’s output or blood pumping capacity is insufficient for the body’s needs. The cause of this deficiency may include several underlying diseases such as ischemia, hypertension, obesity and valvular disease. Irrespective of the underlying cause, in a large percentage of patients, the left ventricle begins to dilate or stretch and enlarge, the muscle wall becomes thinner and the chamber loses its proper shape in an effort to compensate pumping capacity. All of this is accompanied by increasing stress levels for individual heart muscle cells and for the tissue as a whole. As the disease mechanisms are set in motion, this negative chain of events cannot be reversed with conventional treatments. For more information, visit the American Heart Association.
Presently, the following treatment options are available to CHF patients:
- CHF therapy is mostly based on drugs where the objective is to treat early stage disease in order to limit progression and prevent remodelling. However, current drug therapy is palliative; none is curative. Patients are on multiple drugs and their compliance to prescriptions and to care guidelines is a major issue.
- Implantable devices include cardiac resynchronization therapy (CRT) indicated in less than 15% of the CHF population and ventricular assist devices that are implanted in late stage heart failure patients.
- Cardiac surgery serves a small segment of late stage patients where a concomitant ventricle restoration may be performed during bypass or valve surgery. This procedure is rarely used since results are controversial and appear to be highly operator-dependent. Another surgical option is organ transplantation. However, chronic donor shortages limit this choice.
A variety of novel therapies continue to be tried with the aim to reshape the left ventricle and prevent its enlargement. However, the biggest hope for a curative therapy in recent years has come from different types of stem cell therapies. Although stem cells hold the promise to regenerate the damaged muscle of the heart, clinical data has not confirmed the hope and results with different cell sources, protocols, and centers remain inconsistent and thus questionable. A commercial breakthrough is not to be expected in the near- to mid-term.
New strategies to prevent and treat heart failure are needed to curb the rise in the incidence and mortality and morbidity. LoneStar Heart is focused squarely on heart failure and in developing new, more effective therapies that are not limited to a specific molecule or a specific device. Considering the complex factors that affect the disease, we collaborate with a worldwide network of cardiologists, electrophysiologists, heart surgeons, and basic scientists. This collaborative approach has led to the identification and development of several potential therapeutic solutions that may act alone or, for greater effect, in combination with each other.