Cardiovascular disease
(CVD) is the leading cause of death worldwide. The World Health
Organization estimates that 17 million people die of CVD every
year , especially due to heart attacks and strokes, which are
considered a global epidemic. In the United States, one in every
four deaths is caused by heart disease, adding up to nearly
600,000 people per year. In 2010 alone, the total
cost of CVD in the country was estimated at $444 billion.
With the aging of the baby
boom generation, the impact of heart disease on the American
population is bound to grow. In this scenario, innovative ways
to improve prevention and treatment are vital. Federal R&D
Tax Credits are available to support credit eligible CVD
innovation activities.
The R&D Tax Credit
Enacted in 1981, the Federal Research and Development (R&D)
Tax Credit allows a credit of up to 13 percent of eligible
spending for new and improved products and processes. Qualified
research must meet the following four criteria:
New or improved products, processes,
or software
Technological in nature
Elimination of uncertainty
Process of experimentation
Eligible costs include
employee wages, cost of supplies, cost of testing, contract
research expenses, and costs associated with developing a
patent. On December 18, 2015 President Obama signed the
bill making the R&D Tax Credit permanent. Beginning in
2016, the R&D credit can be used to offset Alternative
Minimum tax and startup businesses can utilize the credit
against payroll taxes.
Heart Disease
Cardiovascular disease is a group of diseases pertaining to the
heart and blood vessels. It includes coronary artery disease,
cardiomyopathy (heart muscle disease), heart failure,
cerebrovascular disease (which can result in strokes), valvular
heart disease, cardiac dysrhythmias, and hypertensive heart
disease, among others. Epidemiological studies have identified a
number of risk factors for heart disease. High blood pressure,
diabetes, high LDL cholesterol, overweight, physical inactivity,
poor diet, tobacco smoking, excessive alcohol consumption, age,
gender, and family history can all contribute to the incidence
of CVD. While some factors are unalterable, others can be
changed and are intimately linked to lifestyle choices. Studies
show that 49% of Americans have at least one of three major risk
factors for heart disease (namely, hypertension, high serum
cholesterol levels, and smoking).
According to the Centers
for Disease Control and Prevention (CDC), 83 million Americans
currently suffer
from one or more types of heart disease. In the U.S. alone, one
person has a heart attack every 34 seconds. The social and
economic impacts of CVD are extensive and concern patients,
families, and healthcare providers. The CDC estimates that $1 of
every $6 spent on health care in the U.S. is destined to the
treatment of CVD. CVD treatments vary and can consist of
lifestyle changes, drugs, surgery, transplants, and other
medical procedures, such as the implantation of pacemakers or
implantable cardioverter-defibrillators (ICDs).
Heart Disease Innovation
New
technology and innovative methods have the potential to change
the face of CVD management. The following domains stand out as
promising fields for advancements.
Unveiling New Culprits
Current knowledge of factors that accentuate the risk of CVD
remains deficient. Potential for advancements in the
understanding of what causes heart disease is vast. Two recent
discoveries exemplify the importance of R&D activities in
this domain.
Recent studies have
demonstrated how the consumption of certain foods contributes to
heart disease. Researchers have found that carnitine, present in
red meat, and lecithin, abundant in egg yolks, can increase the
risk of CVD. When digested, both compounds are broken into
choline, which is then metabolized by intestinal bacteria. The
result is an artery-clogging substance denominated TMAO. High
levels of TMAO in the blood are associated with higher risks of
heart attack, stroke, and deaths. These novel discoveries shed
light into a new preventive approach to CVD: controlling the gut
bacteria responsible for TMAO production.
Similarly, researchers
have recently established a link between air pollution and CVD.
A study has shown that higher concentrations of particulate
matters in the air coincide with increased atherosclerosis, or
hardening of the arteries.
Pharmacogenetics
By
analyzing a patient’s genetic profile, oncologists can already
assess the likelihood of success of a certain drug, in other
words, they can distinguish probable responders from
non-responders. Similarly, the study of genetic polymorphisms
that affect responses to cardiovascular drugs can play a key
role in improving the efficacy of heart disease treatments.
However, significant R&D is necessary to allow for
pharmacogenetic factors to be consistently incorporated into CVD
treatment decisions.
CVD Secondary Prevention
Cardiovascular risk assessment remains a major challenge.
Current technology, biomarkers, and diagnostic tools lack
precision in predicting an individual’s probability of
developing CVD. R&D activities aimed at improving screening
and identification of heart disease can greatly contribute to
early diagnosis and targeted treatment, advancements that have
the potential to revolutionize CVD management.
Modification of Risk Factors in
Patients
Important risk factors for CVD are modifiable. However, current
strategies and methods only minimally assist in changing
patients’ harmful behaviors. Smokers, for instance, are
very likely to resume smoking, even after severe medical
procedures.
Adherence to Medication
Patient self-care is also a challenge in CVD management. Studies
show that despite medical recommendations, more than one in five
patients discontinue the use of aspirin, beta-blockers, or
statins within one month after suffering a heart attack. Novel
and effective methods to improve adherence to medication are
crucial to reduce CVD mortality rates.
CVD Management for Specific
Populations
CVD
rates vary according to race, ethnicity, and gender. Further
research is necessary to understand the disparities in heart
disease risk factors throughout different populations. R&D
activities can help create novel approaches to treatment and
prevention, especially designed for certain groups of people.
Heart Disease R&D Activities
Significant heart disease R&D activities are currently
underway. The diversity of projects and objectives to be
attained exemplify the immense potential for innovation.
On March 19th, the
University of California, San Francisco (UCSF) launched the
Health eHeart Study. The project consists of the use
mobile devices, such as smartphones, to monitor patients.
Information is instantly sent to physicians who analyze the data
and provide immediate feedback. The initiative will engage about
1 million people from around the world. Researchers expect that
the huge gathering of data will help “better understand how the
heart functions and to develop new ways to predict and prevent
cardiovascular disease” , in other words, it will use available
technology and big data to make heart care delivery more
precise. Moreover, UCSF’s initiative will allow patients to stay
constantly connected with doctors, a situation that can make a
difference in daily lifestyle choices.
Heart bypass surgery has
also been the subject of innovative efforts. Saphenous veins
have traditionally been attached to blocked arteries to allow
blood flow to “bypass” the blockage. Thinner than arteries, the
saphenous vein grafts tend to enlarge, commonly resulting in the
accumulation of plaque, which can ultimately obstruct blood
flow. The eSVS® Mesh, created by Kips Bay Medical, was designed
to increase the saphenous vein’s strength and avert its
enlargement. It consists of a very thin and flexible tube of
knitted mesh metal (nitinol) to be placed around the graft. Dr.
J. Alan Wolfe from the Northeast Georgia Medical Center stated
the product “could be the biggest game-changer heart surgery has
seen in decades”. The first experimental procedure was performed
last February as part of a preliminary feasibility clinical
trial approved by the U.S. Food and Drug Administration (FDA).
R&D activities to
facilitate early diagnosis are also underway. The Texas Heart
Institute at St. Luke’s Episcopal Hospital has been working on
the development of a “noninvasive, cost-effective, simple, and
widely accessible imaging tool for earlier detection of
atherosclerotic plaques by altering existing technologies”. In
collaboration with the University of Texas, researchers have
developed a nanoparticle for detecting atherosclerotic plaques,
which is expected to heighten the capabilities of existing
technology.
Another example of
innovative diagnosis comes from Fayetteville, Arkansas. The
startup CardioWise has developed a non-invasive Cardiac Magnetic
Resonance Imaging (cMRI) analysis software able to produce
quantified 3D image models of the heart. The Multiparametric
Strain (MPS™) heart analysis delivers highly detailed
quantitative assessments of cardiovascular health. The in-depth
analyses of the myocardium, arteries, and valves are expected to
greatly contribute to treatment decision-making and monitoring
of heart patients.
LoneStar Heart Inc., a
Laguna Hills medical device firm, has also invested in heart
disease innovation. The company has recently mobilized $20
million for the clinical trial and regulatory approval for
Algisyl-LVR, a biopolymer for treating advanced heart failure.
When injected to the heart’s left ventricle, the Algisyl-LVR
thickens into gel-like bodies that protect the muscle from
excessive stress. The novel regenerative treatment is expected
to avert the evolution of heart failure and restore the muscles’
normal functions.
Industry Implications
The
Affordable Care Act (Obamacare) will be penalizing hospitals who
readmit patients originally admitted for chronic conditions,
mainly heart and lung issues (which comprise over 80% of all
Medicare enrollees). These penalties will be levied
against hospitals regardless of the reason for
readmission. In 2015, penalties will reach 3% of Medicare
payments to the facility, which for many facilities will be in
the multiples of millions in lost dollars. The list of
conditions assessed currently includes heart attack, heart
failure, and pneumonia. Given the key role of heart disease for
hospital readmissions, it is reasonable to presume that more
effective treatments and technologies to manage CVD will become
a priority.
Conclusion
New
diagnostic tools as well as innovative treatments for heart
failure and bypass surgeries are examples of promising heart
disease R&D initiatives. Progress, however, is still
urgently needed in various fields, from the unveiling of new
causal relations to the study of CVD in specific populations.
Federal tax credits are available to support eligible heart
disease R&D activities.
