Christus Trinity Mother Frances is researching never-before-seen life-saving projects that have the potential to change the medical field, all in Tyler.
From research about COVID-19 and its effect on the lungs to groundbreaking technology to help with congestive heart failure, these four current research topics have a major impact on the medical field and society.
ACTIVWith COVID-19 still an ongoing issue in the United States and worldwide, it is essential to learn as much as possible to prevent its spread.
Christus is currently participating in two new research programs called ACTIV-1 and ACTIV-4c. ACTIV stands for Accelerating COVID-19 Therapeutic Interventions and Vaccines.
Pulmonologist Dr. Suman Sinha, who is working on both of these trials, said these studies are important in educating people about the disease and developing medicine-based evidence, especially with a current rise in case numbers.
Being such a new disease, there are not any evidence-based approaches for treating COVID-19, Sinha said. Researchers are working to build this evidence and come up with an effective, widespread standard of care for the virus.
Hopefully, as more research is done, the work they are doing with the ACTIV studies can be applied in other areas as well, such as some medications used in these trials being used for other diseases, Sinha said.
For example, ACTIV-1 deals with lung injury from COVID-19, so it is possible that effective medications could be applied to things like influenza A, which can also cause respiratory illness, he explained.
ACTIV-1 studies look at the time it takes a patient to recover when immunoregulators (something that can affect the immune system) are used. These immunoregulators are used to control the patients’ immune system, preventing it from overreacting and damaging tissue.
“We know that if somebody gets infected with COVID, and other things, that the immune system can sometimes overshoot and lead to significant damage, like in a person’s lungs,” he said.
There are several different medications that can prevent the immune system from causing damage in patients who had COVID-19 being looked at in the ACTIV-1 trials, Sinha said.
ACTIV-1 trials are still new, so preliminary results are not currently available. However, the interim analysis is underway.
With ACTIVE-4c, the formation of blood clots, also known as the hypercoagulable state, associated with COVID-19 is being studied, Sinha said. The goal is to see if blood thinners are beneficial in combating this hypercoagulable state.
The formation of blood clots can inhibit the blood and oxygen delivery to vital organs like lungs and kidneys. Patients have been enrolled in the trials for ACTIV-1 and ACTIV-4c enrollment is beginning soon.
“Nationwide and worldwide these studies are actually ongoing, so the interim analysis will be interesting,” Sinha said. “There are literally over 1,000 patients enrolled in these trials already.”
Some requirements to become a part of ACTIV-1 trials include having a known diagnosis of COVID-19 proven by antigen testing or polymerase chain reaction (a test to detect genetic material from an organism such as a virus), older than 18, not pregnant, and have a chest x-ray proving COVID-19-related pneumonia and low oxygen levels.
Enrollment in the clinical trials is encouraged and greatly appreciated, he said.
“One of the most important things to remember is that a clinical trial is a very noble thing that a patient can do,” Sinha said. “It really does contribute to the scientific evidence that we need in order to treat this disease.”
Stroke treatmentEvery day there are 800,000 strokes, an increase in the 700,000 a day reported last year.
Oftentimes, people do not think anything is wrong when they have a stroke. They may just think that their arm is numb or that they slept on it wrong when they’re actually having a stroke, Dr. Kurt Reuland, an interventional neuroradiologist, said.
The newest wave of medical technology, TIGERTRIEVER and RED 62, are devices to more successfully and quickly open blocked arteries in the brain during procedures to better combat strokes.
No one thought these new devices would actually work, Reuland said. When the technology proved to more effectively reopen the blood flow in the brain, physicians were shocked.
Brain circulation is very delicate, meaning the devices used need to be soft but also strong enough to pull out a clot without causing a brain hemorrhage, he said. RED 62 is a big advancement in safely removing clots from the brain.
When RED 62 was in the process of getting approved by the Federal Drug Administration it was given to five centers, including Christus, Reuland said. Out of the 10 cases the FDA wanted completed, he performed six.
RED 62 is a catheter that works by sucking the clot out of the brain similar to how a vacuum would, he said. This procedure has proven to be so successful that several different sizes of the catheter are being made to use in other places like the heart and the legs.
TIGERTRIEVER is another device, which looks similar to a net, that Christus is second in the country to use.
The TIGERTRIEVER is placed on the clot and then the doctor can put the RED 62 on it to clean the clot out of the vein, Reuland said. This device can be used in other places in the body as well.
This technology is advanced enough that open brain surgery doesn’t really need to be used anymore, he said. Things are constantly being improved further, lowering complication rates and making it less invasive, allowing for a much shorter recovery time.
With these advancements in stroke technology that Christus has access to, the amount of people that recover after undergoing a procedure is more successful overall.
“There’s a significant number of them that completely recover, but overall we have a 70% rate of functional recovery on these patients that otherwise would just be devastated,” Reuland said.
He said in his 20 years as a doctor, so much has already changed and it seems like the field of medicine is in a renaissance period, constantly advancing. In fact, in the next couple of months, Christus will be receiving even more new technology yet to be announced to the public to help with stroke procedures.
With their research and performance in combating strokes, Christus has become a comprehensive stroke center, meaning the health system has the capability to treat even the most complex stroke cases.
Watchman FLXChristus Health is among one of the first places in the United States to have the Watchman FLX technology.
There is a specific, unmet need that the Watchman FLX device was designed to combat, Dr. Stan Weiner, director of electrophysiology, said. The device helps treat patients with atrial fibrillation, the most common arrhythmia (a problem with rate/rhythm of the heartbeat) and the leading cause of stroke.
A-fib is an abnormal heart rhythm, Weiner said. It can either be persistent where the heart rate stays out of rhythm, or paroxysmal where irregular heart rates come and go.
The Watchman procedure itself has been around for about 15 years, five of which commercially available in the United States. The second generation of the Watchman, the Watchman FLX, has been around for about a year.
“With your heart being a pump, it has an electrical system that drives it and determines the heart rate,” he said. “When you go to sleep, your heart rate is slow, when you exercise, your heart rate is fast, your heart rate adjusts to your activity levels. That is how the heart is designed, that is how it normally works.”
The goal of the Watchman procedure is to get rid of the risk of A-fib causing strokes, not the condition itself, Weiner said. Many patients may still have symptoms such as irregular heartbeat and tiredness.
He added patients who see a lot of other symptoms associated with A-fib typically benefit from additional procedures such as ablation (a procedure for restoring regular heart rhythm) or types of medication.
The Watchman FLX device has proven to be safer and easier to use and can be for many different patients including those with unusual anatomy, older people and sicker people.
Christus has been able to do trials on the Watchman FLX along with some commercial implants and has received great responses, proving this second generation is much better technology than the first, Weiner said. So far they have done about 150 Watchman FLX procedures.
Patient Nancy Grant said she’s grateful to be a part of this trial and hopes it can help others, like some of her family members who have A-fib.
“I’m just glad that I was in the right place at the right time to get this,” Grant said. “I’m hoping in the future it’ll help my daughter and nephew.”
Another good thing about the Watchman procedure is that it is a good option for replacing blood thinners, he added. Patients are protected from the risk of stroke and they don’t have to use blood thinners.
Grant said she hasn’t had to use blood thinners since having the Watchman FLX procedure. She noted how expensive blood thinners are and the bruising the medicine causes.
The best patients to use the Watchman FLX device on are still being looked into further, Weiner said.
The main area of study for the Watchman FLX is currently the use of it on these lower-risk patients, Weiner said. Patients who are at low risk for stroke and can tolerate blood thinners will be randomized to see if the Watchman FLX or the newest blood thinners work best for them. They will be monitored for a few years to determine which strategy is the best moving forward.
“We have very clear inclusion and exclusion criteria,” Weiner said. “In order to put somebody in a trial we kind of need to make sure that we know what it is we’re studying.”
All patients that become a part of the trial must have A-fib and have factors that put them at a high risk of stroke because of A-fib. The patients also need to either be on or eligible to be on a blood thinner.
Christus was among the first about a year ago to have access to the Watchman FLX device, Weiner said. Now, the device is available to most people who need it. With studies still ongoing about its use on low-risk patients, these individuals may only be able to get it through the enrollment of a trial.
Relief-HFCongestive heart failure is a significant problem that causes people to feel miserable from day to day and causes death. Relief-HF is designed to treat heart failure and give people quality of life.
Numerous treatments are available for heart failure including daily pills, heart pumps and transplants, but even when using the best treatment, there are times when it is still difficult for people to breathe, get around or have energy, Weiner said.
He added some of these treatments are simple and accessible, while others are more involved and invasive. For example, if a heart transplant is needed, the first step is for doctors to go in and take out the heart, which has a lot of risks and issues associated with it.
To combat this, trials are being done on the device Relief-HF, one of the most significant cardiovascular trials designed to reduce symptoms of heart failure, he said. This treatment is new and can be used on top of other treatments like pacemakers and medications.
“It seems to have a relatively low risk of complications and problems and it’s not as involved as some of the more invasive or aggressive treatments,” Weiner said. “It’s something that will help patients symptomatically a bit.”
A major issue with heart failure is the build-up of fluid on the left side of the heart, he said. Researchers are using a shunt (a tube that connects parts of the body that were not previously connected) to get some of the extra fluid in the left side of the heart back to the right side. This helps reduce symptoms of heart failure.
“It creates kind of like a pipe or a valve that avoids the build-up of excessive pressure on the left side of the heart,” he said.
Another benefit of Relief-HF is that, unlike medications, it will continue to provide the patient with relief without them having to make tweaks, Weiner said.
The trial for Relief-HF is ongoing at Christus. There are only a few sites in Texas including Christus, that have been able to enroll several patients so far.
Patients in the trial are individuals who are taking optimal medications but are still experiencing significant heart failure.
While this treatment cannot cure heart failure, Weiner said he believes it will be a lasting fix based on the positive responses in the trial thus far.
Diana Gill, a patient in the Christus Relief-HF trial, said her doctor recommended her to be in this trial based on how her congestive heart failure was impacting her life.
“I was spending a lot of time in the hospital with my congestive heart failure,” Gill said. “I didn’t want that anymore, it wasn’t safe or anything like that. Because my heart is so weak, anything that can make it work better is always a plus.”
Back in August, she underwent the Relief-HF procedure and she thinks it’s helping because she’s gone to the hospital less.
During trials, patients are randomized into those who will be receiving the active treatment (Relief-HF) and those who will have their medications maximized. This allows the two treatments to be compared.
He added an important thing is making sure that the Relief-HF is actually effective. He said he has seen instances where people have a placebo effect in response to treatment because they’re eager to get better.
“We want to make sure that if we’re going to offer you a treatment, this is something that’s going to offer you durable relief,” Weiner said.
Heart failure is extremely common, but treatments such as Relief-HF are only available through a clinical trial.