Top 10 Innovations for 2011
Which are the up-and-coming technologies and which will have the biggest impact on healthcare in 2011?
Cleveland Clinic's culture of innovation naturally fosters a good deal of discussion about new "game changing" technologies and which ones will have the greatest impact each
year. The passion of our clinicians and researchers for getting the best care for patients drives a continuous dialogue on what state-of-the-art medical technologies are just
over the horizon.
This book was developed to share outside Cleveland Clinic what our clinical leaders are saying to each other and what innovations they feel will help shape healthcare over the
next 12 months.
We used a rigorous process to gather the opinions of Cleveland Clinic physicians and researchers, create a field of nominated innovative technologies for consideration, and develop
a consensus perspective of what will be the Top 10 Medical Innovations for 2011. Our team interviewed more than 60 Cleveland Clinic experts to elicit their nominations.
#1 New Molecular Imaging Biomarker for Early Detection, Prevention, and Treatment of Alzheimer's Disease:
Alzheimer's disease (AD) is like a crafty burglar: It quietly gains entrance and steals all that is precious from the brain, then loiters around the scene of the crime, cleverly
avoiding all means of detection while the brain slowly deteriorates from its irreplaceable losses.
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#1 New Molecular Imaging Biomarker for Early Detection, Prevention, and Treatment of Alzheimer's Disease:
Florbetapir, the new brain imaging compound, will make early detection of Alzheimer's disease possible by identifying the initiation of brain damage. Injection of this
radioactive molecular imaging compound "binds" to amyloid plaques, which is the telltale 'signature' characteristic of Alzheimer's. Follow-up imaging allows physicians to effectively peer
into the brain of a patient and assess.
While the biomarker did not receive initial FDA approval in 2011, it was deemed relatively safe and will be reconsidered by the FDA once
an accurate and consistent training program is established for physicians to interpret the scans.
Anti-CTLA-4 Drug (ipilimumab), Targeted T-Cell Antibody for Metastatic Melanoma:
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells located in the skin. While anyone can develop melanoma, it is still not clear how all
melanomas develop.
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Anti-CTLA-4 Drug (ipilimumab), Targeted T-Cell Antibody for Metastatic Melanoma:
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells located in the skin. Although melanoma accounts for barely 3% of skin cancer
cases, it causes the most skin cancer deaths. A new drug called ipilimumab specifically blocks the action of the protein molecule, CTLA, which is found on white blood cells and suppresses the immune
system from fighting disease. Ipilimumab targets CTLA and allows the patient's immune system to fight the cancer more vigorously.
Ipilimumab was approved by the FDA in March 2011 and is
currently being investigated in clinical trials for use in treatment of prostate cancer and non-small cell lung cancer.
#3 First Therapeutic Cancer Vaccine Approved by the FDA:
After 15 years of research and a roller-coaster ride at the U.S. Food and Drug Administration (FDA) that went on for several years, sipuleucel-T (Provenge) recently became the first cancer vaccine
ever approved by the FDA, ushering in a new era in the ongoing war on cancer.
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#3 First Therapeutic Cancer Vaccine Approved by the FDA:
Vaccines have long been the dream of cancer researchers for more than a century. Now there is sipuleucel-T for advanced prostate cancer. Unlike a traditional preventive vaccine-such as a
flu or measles vaccine-that revs up the immune system to help prevent infection, sipuleucel-T is a therapeutic vaccine given to men with advanced prostate cancer to get their own immune systems to develop
a response against the disease, leading to improvement in survival.
Shortly after its approval by the FDA in 2010, the vaccine was added to the National Comprehensive Cancer Network's list of
cancer treatments as a "category 1" treatment for hormone resistant prostate cancer. Research is continuing the quest to develop more therapeutic cancer vaccines.
#4 JUPITER Study, Statins for Healthy Individuals:
Approximately 785,000 Americans will have a heart attack for the first time this year while another 470,000 will have a repeat attack. Heart attacks strike both men and women, young and old, and in almost
20% of cases, these myocardial infarctions are deadly.
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#4 JUPITER Study, Statins for Healthy Individuals:
JUPITER, an intervention trial, pointed out for the first time that many seemingly healthy people are actually at higher risk for cardiovascular disease than previously thought. It's estimated
that about 80% of the people who have a myocardial infarction have cholesterol levels that are no higher than the levels of many people who are not having heart attacks and have not experienced any cardiovascular
symptoms. JUPITER study data reported that the use of statin medications by seemingly healthy study participants cut their risk of cardiovascular disease and death by almost 44% compared to those treated with
placebo.
Despite JUPITER's promising findings, subsequent reviews of the study found potential flaws in its design and interpretation, partly due to an over-reliance on biomarkers as endpoints. The
reviews cast doubts on the efficacy and safety of statin medications. However, many physicians maintain there is evidence from the study that statins help prevent heart disease in certain groups of healthy
people.
#5 Hepatitis C Protease Inhibiting Drugs:
Hepatitis C, a common liver disease that affects an estimated 3.9 million people in the United States, is transmitted through exposure to infected blood (blood was not screened for hepatitis C until 1992)
and sexual contact with an infected person.
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#5 Hepatitis C Protease Inhibiting Drugs:
The best cure rates of hepatitis C, a common liver disease that affects an estimated 4 million Americans, come from a combination of the oral antiviral medicine ribavirin and an injectable interferon.
The flulike side effects of these drugs are often debilitating leading many patients to stop treatment. There are an estimated 300,000 Americans with hepatitis C who have failed this treatment protocol. Two advanced
drugs called hepatitis C protease inhibitors have the ability to fundamentally change the treatment for hepatitis C by blocking a key enzyme that viruses need in order to reproduce.
The FDA approved both
drugs in 2011, paving the way for a new-line of treatment options for hepatitis C. A newly completed trial with one of the drugs showed significant improvement in cure rate and treatment time, even beyond the
original findings.
#6 Telehealth Monitoring for Individuals with Heart Failure/Implanted Wireless Cardiac Device for Monitoring Heart Failure:
A weakening of the heart's ability to pump blood throughout the body causes heart failure. Between 500,000 and 900,000 new cases are diagnosed each year in the United States, making this debilitating ailment
the most common diagnosis in Medicare patients.
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#6 Telehealth Monitoring for Individuals with Heart Failure/Implanted Wireless Cardiac Device for Monitoring Heart Failure:
A weakening of the heart's ability to pump blood throughout the body causes heart failure. Between 500,000 and 900,000 new cases are diagnosed each year in the U.S. Wireless healthcare and a variety of
technology-based remote patient monitoring devices are now playing a major role in heart failure management, providing a more effective way for physicians to gain critical information about their patient, to adjust medication
when necessary, and keep the patient healthy and out of the hospital. Various sophisticated methods of assessing heart failure control are now in use or in final testing phases, including an implantable, miniature,
permanent monitor with communication technologies that measures and transmits daily pulmonary artery pressure levels, a key indicator of heart health.
The various home monitoring devices have proven to be effective at
reducing hospitalizations in randomized controlled trials, and the manufacturer of the implantable wireless device anticipates FDA approval for the heart sensor within the next year.
#7 Endoscopic Weight-Loss Procedure Transoral Gastroplasty (TOGA):
Rates of overweight and obesity, higher than ever in the United States, are both linked with an increased risk of life-threatening conditions, including heart disease, stroke, type 2 diabetes, and cancer. Moreover,
obesity can lead to psychological distress as a result of poor self image, social isolation, and job discrimination.
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#7 Endoscopic Weight-Loss Procedure Transoral Gastroplasty (TOGA):
More than 10% of American men and 18% of women are severely obese, a chronic condition that is extremely difficult to treat. A viable option to promote weight loss by restricting food intake is bariatric
surgery. Most procedures are done laparoscopically, in which instruments are inserted through a tiny incision in the abdominal wall. TOGA is a weight-loss option for obese patients who want to lose weight and improve their
health without undergoing major surgery. This endoscopic method eliminates complications and offers a "scar-less" procedure. TOGA represents a significant improvement in minimally-invasive bariatric surgery and losses
approaching 40% of excess body weight can be expected within a year.
Due to a poor response in clinical trials from lack of efficacy, the company behind the procedure went out of business in late 2010. However,
bariatric surgery is becoming more accessible, and a myriad of innovative products are being developed in hopes of circumventing the need for surgery.
#8 Exhaled Nitric Oxide (NO) Breath Analysis for Monitoring Asthma:
Asthma is a chronic inflammatory lung disease that affects more than 23 million Americans. Characterized by prolonged or uncontrollable coughing, wheezing, tightening of the chest, and increased mucus secretion, an
asthma episode narrows and blocks the airways and makes breathing extremely difficult.
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#8 Exhaled Nitric Oxide (NO) Breath Analysis for Monitoring Asthma:
Asthma is a chronic inflammatory lung disease that affects more than 23 million Americans. In order to know how efficiently a patient's lungs are functioning, an exam is given by a doctor using a spirometer.
It has been increasingly recognized by pulmonary experts that these in-office exams tell only part of the asthma story. There is now a new FDA-approved hand-held diagnostic testing device that measures levels of exhaled nitric
oxide. Known as "NO," this gas produced by cells that line the inner walls of the lung's airways has been identified as a biomarker for asthma. The amount of NO in the exhalation indicates how much inflammation there is in
the lungs-and the severity of the asthma. NO's breath analysis is destined to play a valuable role in adding precision and accuracy to the diagnosing, monitoring, and pharmacological management of people with asthma.
Good asthma control is critical. This groundbreaking and non-invasive diagnostic technique is now becoming a reality in clinical practice. New guidelines from the American Thoracic Society were introduced in 2011 to provide
clinicians with a user-friendly reference for the standardized interpretation of the exhaled NO results.
#9 Oral Disease Modifying Treatment for Multiple Sclerosis:
Multiple sclerosis, more commonly known as MS, is thought to be an autoimmune disease that causes the body's immune system to mistakenly attack the central nervous system.
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#9 Oral Disease Modifying Treatment for Multiple Sclerosis:
Multiple sclerosis (MS) is thought to be an autoimmune disease that causes the body's immune system to mistakenly attack the myelin in the central nervous system. There are seven FDA-approved drugs that can
modify the course of the disease, but they must be injected or infused on a daily or regular basis, and this is enough to discourage many people from consistently following through with their therapy because of the bother and
sometimes-painful side effects. The new fingolimod capsules works differently from all other first-line MS therapies. By successfully preventing the migration of T cells from the lymph glands to the brain and spinal cord, the
drug effectively keeps these marauding cells from attacking the fatty myelin sheaths that cover the nerve fibers. The drug represents a big step forward in treating the underlying causes of this debilitating disease, slowing
the progression of disability, reducing its frequency and severity, and ultimately improving the lives of people with MS.
Approved by the FDA in 2010, fingolimod was approved for use in Europe and Canada in 2011.
Clinical trials are still evaluating the drug, which despite some safety concerns, is generally effective as a new-line of treatment for MS.
#10 Capsule Endoscopy for Diagnosis of Pediatric GI Disorders:
One of the most challenging problems in pediatric digestive medicine is finding the source of hidden bleeding in the gastrointestinal (GI) tract.
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#10 Capsule Endoscopy for Diagnosis of Pediatric GI Disorders:
One of the most challenging problems in pediatric digestive medicine is finding the source of hidden bleeding in the gastrointestinal (GI) tract. When traditional endoscopic imaging techniques using a fiber
optic scope or x-ray failed to reveal the source of unexplained bleeding in the area between the stomach and colon, surgery was often a next step. However, for these difficult-to-diagnose cases, many doctors are turning to a
high-tech imaging tool called video capsule endoscopy for its detailed high-resolution images of the entire small intestine, an area that is one of the most difficult parts of the GI tract to view with traditional procedures.
It all starts by having the child swallow the pill-sized capsule that has the miniature camera inside.
Capsule endoscopy is becoming a standard method of assessing pediatric GI disorders. In one recent study, use of
a capsule endoscopy led to a new diagnosis and change of therapy in nearly 70% of patients. Innovation continues to refine the technique: In 2011, Japanese researchers developed a self-propelled endoscopy capsule.
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