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The Cleveland Clinic announced its Top Ten medical innovations of 2014 this morning. They include three from Clinic physicians and researchers, and the list is topped by a prosthetic retina that is able to restore sight to people with retinal degeneration.

(Plain Dealer file)

CLEVELAND, Ohio-- A bionic retina, capable of restoring rudimentary sight in patients after years of near blindness, is the No. 1 medical innovation for 2014 at the

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The top 10 medical innovations expected to have the biggest impact in the coming year were announced this morning to the roughly 1,400 doctors, researchers and industry leaders attending the summit in downtown Cleveland at the newly opened Global Center for Health Innovation. The facility, formerly known as the medical mart, is attached to the convention center complex, site of most of the summit's three days of meetings.

The Clinic is directly involved in the research or development of three of the innovations featured this year. More than 110 Clinic staff members made 150 nominations for the list in the spring, and expert committees within the health system pared down the selections.

Dr. Thomas Graham, chief innovation officer at the Clinic, said the list reflects some new and unapproved medical treatments and some devices and treatments in the works for a decade or more that have only recently become poised to make a significant difference in patient care.

An example of the latter is second on the Top Ten list this year, a way of analyzing the genetic changes in individual tumors to prescribe precision treatments for each patient that will help reduce the use of unnecessary medical procedures and medications, and help save lives.

Here are this year’s Top 10 innovations:

1. Retinal prosthesis system

This year, the Food and Drug Administration approved the use of a tiny implant that can help detect light in the eyes of people who have gone blind due to diseases like macular degeneration and retinitis pigmentosa (RP).

The Argus II Retinal Prosthesis System was approved in February for severe RP, a group of inherited diseases causing retinal degeneration. RP affects about 100,000 people in the United States, according to the Foundation Fighting Blindness.

Using the retinal prosthesis system, a doctor can surgically implant an array of electrodes in a patient’s eye, and with a combination of video camera-enabled glasses and a processing unit that is worn at the waist, a patient can learn to see and distinguish light and dark again.

At least five other research groups are developing retinal prosthesis systems across the world. In July, the Alpha IMS system was granted European Marketing approval after the German company developing the device found positive results from its preliminary studies, including patients who could make out store signs, doorknobs, and some movement.

2. Genome-guided solid tumor diagnostics

In 2011, researchers at the Clinic published preliminary results showing that a method for studying the genes, or DNA, of an individual's prostate cancer, could help determine if the disease was aggressive enough to merit immediate treatment or slow-growing enough to watch closely instead.

This method, called genomics, has also been used for years to help predict if post-surgery chemotherapy is necessary for breast cancer patients.

Now, after a larger study validating the technique in prostate cancer was published earlier this year and the genetic analysis technology is more widely available, cancer researchers believe they are poised on the threshold of a new era in their field.

Right now, there may be cancers where 80 percent of patients respond to standard treatment, but the remainder do not, said Dr. Eric Klein, chairman of the Glickman Urological and Kidney Institute at the Clinic and part of the research team that published the original work on genomics in prostate cancer.

Dr. Eric Klein

“There’s going to come a time in the future when we’ll be able to say to that 20 percent who don’t respond to standard therapy ‘you can avoid that and go right to this other treatment that will work better,’” he said.

The Clinic is enrolling 200 patients with solid tumors who have not responded to other treatments to have their cancers analyzed by Massachusetts-based genomics company Foundation Medicine. The company will offer treatment recommendations based on the genetic information they glean from each patient's tumor tissue, Klein said.

“The idea is that you pick the right drug that already exists to treat the specific thing that is making your tumor grow,” he said. “Precision medicine is here, and it’s pretty exciting.”

3. Responsive neurostimulator for intractable epilepsy

About one third of the more than 2 million Americans with epilepsy will end up having seizures that do not respond to medical treatments.



The device, which received the backing of the FDA's neurological advisory panel in February, is surgically implanted under the skin on the skull and analyzes electrical patterns coming through leads that are placed on the patient's brain in the area that is causing seizures. Seizure triggers can be picked up by the device and short-circuited with quick electrical pulses.

The NeuroPace RNS system is similar to other neuromodulation therapies on the market, including last year's No. 2 innovation, a therapy that interrupts the pain of migraine and cluster headaches with electrical stimulation delivered through an almond-sized device implanted in the upper gum.

4. Direct-acting antiviral oral hepatitis C drugs

Treatment for hepatitis C, a viral disease affecting the liver, has advanced rapidly in the past five years with the approval of several drugs that improved cure rates considerably over existing medication regimens.

Now, the FDA is close to approving an all-oral treatment for the disease, which affects more than 3 million people nationwide. The drug, called Sofosbuvir, would be the first of a new generation of drugs that could drastically cut down the time it takes to treat the disease—often up to 48 weeks—and eliminate the need for injected interferon, a drug that is difficult for patients to tolerate.

5. Perioperative decision support system

Anesthesiologist David Brown, now chair of the Clinic's Anesthesiology Institute, was flying his private plane over Texas about a decade ago when he suddenly had an idea: why not have a system in the operating room sending out alerts and offering advice about performance measures the same way he was receiving information from his airplane computers and air traffic controllers?

Dr. David Brown

Almost as soon as he landed, he started writing up his idea for this computer-based decision support system, and now, a Clinic spinoff company, Talis Clinical, is readying the system for use in other hospitals around the country.

Brown and the Clinic have been testing it in their operating rooms for the past 3 years. The system uses a set of algorithms running in the background behind all of the equipment in the operating room to keep tabs on a patient’s vital signs and anesthetic data during surgery. Using evidence-based data on patient outcomes, the system sets off alarms or notices for doctors, nurses and surgeons when there is a potential problem, Brown said.

“We also created almost like an air traffic control monitor in an operating room suite so that real-time we know which patients might be receiving alerts, and the central part of our practice can then send more help if needed or know which patients seem to be doing well,” he said.

Alerts can go to a central monitoring desk, individual operating rooms, or communication devices like iPhones. Brown said the Clinic has improvements in maintaining blood pressure post-operatively when using the system.

“The computer picks up on some statistically significant items that the human mind would actually look past in the hustle and bustle,” he said. “The computer is actually a better vigilance monitor because it doesn’t get bored and it doesn’t get tired, and it will do whatever you program it to.”

6. Fecal microbiota transplantation

Fecal transplants — depositing feces from a healthy person into the colon of someone who is sick — have a high ick factor, but are proving surprisingly effective at treating intestinal infections such as C. difficile, which can cause cramps, abdominal pain and diarrhea so frequent and severe, they keep people from their daily activities.

C. diff kills an estimated 14,000 to 30,000 people in the United States every year, and may contribute to an additional 100,000 deaths. The disease is usually treated with one of two powerful antibiotics, which can be expensive and not always effective.

Fecal transplants, which doctors are offering at a growing number of hospitals across the country, can be performed in a number of ways. Most often, doctors use a colonoscopy-like procedure, sedating a patient and depositing liquified, donated stool through a tube in the rectum. They may also use a nasogastric tube, which goes through the nose, down the throat and into the gut. Other times, the stool is administered as an enema.

In many cases, the transplants offer a cure to patients who have not responded to other treatments: Research shows that more than 90 percent of patients with recurrent C. diff — infections that do not respond to antibiotics — get better after fecal transplants.

7. Relaxin for acute heart failure

Heart failure, which happens when the heart can no longer pump enough blood to keep up with the body's needs, is the most common diagnosis among Medicare patients and accounts for 55,000 deaths annually in the United States.

Heart failure is a chronic, progressive condition with no cure. Symptoms include shortness of breath and buildup of excess fluid in the body.

A new treatment called serelaxin, a synthetic version of the naturally-occurring hormone human relaxin-2, may soon be available to improve symptoms and reduce the risk of death from the condition. Human relaxin-2 is found in both men and women, and is responsible for the increased volume of blood pumped by the heart during pregnancy.

During initial clinical trials, serelaxin improved breathlessness in a group of more than 1,000 patients taking the intravenous treatment infused over a 48-hour period in the hospital following a heart failure episode or a heart attack.

8. Computer-assisted personalized sedation system

Earlier this year, the FDA granted pre-market approval (which requires clinical studies) to a device that would automate the sedation of patients undergoing colon-cancer screenings, saving money on the use of anesthesiologists.

The device allows non-anesthesiologists to administer the sedative propofol during the procedure. The machine monitors the patient’s vital signs and will alert the doctor to abnormalities. Through an earpiece, the device can also awaken a patient who drifts into a deeper than necessary level of sedation.

Johnson & Johnson is marketing the device, called Sedasys.

9. TMAO assay: novel biomarker for the microbiome

In a lab at the Cleveland Clinic's Lerner Research Institute, cardiologist Stanley Hazen has been on the trail of a new biomarker for heart disease that may help identify people who are at risk of heart attack, stroke and death even when traditional risk factors and other screening tools fail.

The biomarker, called TMAO (for trimethylamine-N-oxide) is produced by the liver after bacteria in the intestines digest red meat and other animal products. In three clinical studies, TMAO has been a good predictor of heart disease risk—those with the highest levels of TMAO had risks of negative outcomes that were two to 2 ½ times higher than those with the lowest blood levels of the biomarker.

Dr. Stanley Hazen

Hazen said the TMAO test, which has been licensed to the Raleigh-based diagnostics company Liposcience and is now available for use in clinical trials, helps identify people who might not otherwise be suspected of being at risk.

“I think one immediate potential clinical benefit is that it helps identify people who should be more aggressively treated from a preventive cardiovascular standpoint,” he said.

“The test is important, but so much more important than the test is the concept that gut bacteria are playing a role in heart disease. That opens up all these other avenues for intervention, and that’s the area that we’re really focusing on.”

10. B-cell receptor pathway inhibitors

B-cells, a type of immune cell responsible for producing antibodies to fight off infection and maintain long-term immunity, can also become cancerous and lead to conditions such as Hodgkin’s lymphoma and leukemias.

B-cell receptor pathway inhibitors, a new class of treatments that target the cancer cell division process by interfering with the proteins that tell cancer cells to grow and divide uncontrollably, are now offering a new treatment for these cancers.

Ibrutinib, an oral therapy in this class, targets a protein called Bruton's tyrosine kinase and kills malignant B-cells while leaving healthy immune cells intact, unlike other current therapies. The FDA accepted the new drug application for ibrutinib in August, the last step before the drug's introduction to the market.