CHICAGO – November 15, 2024 – Can lessons from the COVID-19 pandemic help treat cancer? A new study led by researchers at the Northwestern Medicine Canning Thoracic Institute and published in the Journal of Clinical Investigation has revealed a connection between COVID-19 infection and cancer regression. The team’s discovery could pave the way for novel cancer treatments.

In an unexpected twist, researchers observed that the RNA from the SARS-CoV-2 virus – responsible for COVID-19 – triggered the development of a unique type of immune cell with anti-cancer properties. These cells, dubbed “inducible nonclassical monocytes (I-NCMs),” were found to attack cancer cells and could potentially be harnessed to treat cancers that are resistant to current therapies. These findings possibly explain the mechanism behind the reported regression of certain cancers following COVID-19 infection.

“This discovery opens up a new avenue for cancer treatment,” said Ankit Bharat, MD, chief of thoracic surgery and director of the Canning Thoracic Institute. “We found that the same cells activated by severe COVID-19 could be induced with a drug to fight cancer, and we specifically saw a response with melanoma, lung, breast and colon cancer in the study. While this is still in the early stages and the effectiveness was only studied in preclinical animal models, it offers hope that we might be able to use this approach to benefit patients with advanced cancers that have not responded to other treatments.”

The study, conducted using both human tissues and animal models, found that these unique immune cells could be pharmacologically stimulated using small molecules, potentially creating a new therapeutic option for cancer patients. This discovery could have significant implications, particularly for patients with aggressive or advanced cancers who have exhausted traditional treatment options such as immunotherapies.

How the Body’s Response to COVID-19 Could Help Fight Cancer
The researchers discovered that during COVID-19, a special subset of immune cells can be stimulated in the body. This process begins when the RNA from the virus activates certain signals in the immune system. These signals cause the transformation of common monocytes – an ordinary type of white blood cell – into I-NCMs. These newly formed cells have the ability to move into both the blood vessels and the surrounding tissue where tumors grow, something most other immune cells can’t do.

“What makes these cells so special is their dual capability,” said Dr. Bharat, who is also professor of surgery at Northwestern University Feinberg School of Medicine. “Typically, immune cells called non-classical monocytes patrol blood vessels, looking for threats. But they can't enter the tumor site itself due to the lack of specific receptors. In contrast, the I-NCMs created during severe COVID-19 retain a unique receptor called CCR2, allowing them to travel beyond blood vessels and infiltrate the tumor environment. Once there, they release certain chemicals to recruit body’s natural killer cells. These killer cells then swarm the tumor and start attacking the cancer cells directly, helping to shrink the tumor.”

What’s Next?
While this research is promising, Dr. Bharat cautions that more work is needed before this approach can be used in clinical settings.

“We are in the early stages, but the potential to transform cancer treatment is there. Our next steps will involve clinical trials to see if we can safely and effectively use these findings to help cancer patients,” added Dr. Bharat.

The team hopes that, with further research, they can develop therapies that specifically target these cells to treat cancers that are currently difficult to manage. This could lead to new treatment options for patients who have exhausted all other possibilities.

The research could potentially play an important role with the Canning Thoracic Institute’s Double Lung Replacement and Multidisciplinary Care (DREAM) Program, a first-of-its-kind clinical initiative at Northwestern Medicine that provides double-lung transplants to select patients with advanced lung cancers who are not responding to conventional treatments. To date, more than 40 patients have received double-lung transplants through the DREAM Program.

“While the program has been highly successful, we do anticipate that some patients might have recurrence. Since we’re using monocytes with our research, we could potentially treat DREAM patients without risking rejection of their new lungs,” said Dr. Bharat.

The research was funded by the National Institutes of Health (NIH), Canning Thoracic Institute, and conducted by a team of scientists from Feinberg School of Medicine and clinicians at Northwestern Memorial Hospital. For more information about Northwestern Medicine, visit nm.org. 

Chicago – October 24, 2024 – Northwestern Medicine has announced a major new center focused on leveraging insights from artificial intelligence (AI) for rapid discovery in Alzheimer’s disease research.

 A $25 million gift from Wendy and Jim Abrams and the Eleven Eleven Foundation will endow the The Abrams Research Center on Neurogenomics at Northwestern University Feinberg School of Medicine, with a mission to drive scientific innovations and develop effective interventions for Alzheimer’s disease. The new center, led by David Gate, PhD, assistant professor of Neurology in the Ken and Ruth Davee Department of Neurology, will integrate AI and other leading-edge genomics technologies, computational approaches and strategic international collaborations.

 "We are thrilled to support the world-class research team at Northwestern Medicine. Through collaboration and technological innovation, we are optimistic that their efforts will bring us closer to finding a cure in the near future," said Wendy and Jim Abrams.

Through the establishment of the center, the Northwestern team will create a suite of new AI tools and analysis methods that allow neuroscientists to interrogate the genes and cell types affected by Alzheimer's disease. The success of these efforts will help fill the chasm between the current understanding of Alzheimer's disease at the level of genes and their functions, with the ultimate goal of developing novel clinical applications.

"This gift has the potential to be transformational in the way we care for and treat patients suffering from Alzheimer’s disease,” said Howard B. Chrisman, MD, president and chief executive officer, Northwestern Memorial HealthCare. “This act of kindness and generosity by Wendy and Jim Abrams and the Eleven Eleven Foundation will have a global reach on patients, caregivers and those impacted by this deadly disease.”

The center will build on established collaborations and work with international scientists to analyze the volumes of data that are currently incomprehensible, but through modern tools can identify key pieces of information that further the science and mystery behind Alzheimer’s disease. These human data sets, provided through clinical and research partnerships, will make the information more accessible to other scientists and foster collaboration within the field. By facilitating agreements with pharmaceutical and AI industry partners, the center aims to streamline research processes, accelerating the pace of discoveries becoming therapeutics.

 About Eleven Eleven Foundation

Eleven Eleven Foundation is dedicated to a healthier, more sustainable world.

About Northwestern Medicine

To learn more about Northwestern Medicine, please visit NM.org.

Published in JTCVS Open, the Acupuncture After Heart Surgery (ACU-Heart) study found that acupuncture is practical, well-tolerated and has clinical benefit for patients who have undergone heart valve surgery, including lower rates of post-operative atrial fibrillation (POAF).

“Heart surgery is a lifesaving procedure, but it can contribute to physical discomfort and surgical side effects like atrial fibrillation (irregular heartbeat), while also having a psychological impact on the patient” says lead investigator, Kim L. Feingold, PhD, a cardiac psychologist and the founder and director of Cardiac Behavioral Medicine at the Northwestern Medicine Bluhm Cardiovascular Institute at Northwestern Memorial Hospital. “We know that the mind and body are connected, so we’re always looking for ways to improve the patient experience and reduce the emotional consequences of heart disease, which can include depression and anxiety.”

Acupuncture is a component of traditional Chinese medicine that has been used for more than 2,500 years and is believed to stimulate the nervous system. The practice involves inserting thin needles through the skin at specific points along the body to influence the flow of energy and promote healing. Acupuncture has been shown to have pain-relieving, anti-inflammatory and anti-nausea effects.

In the ACU-Heart pilot trial, consenting patients undergoing valve surgery with no prior history of atrial fibrillation (AFib), were randomly sorted into two groups. One group received standard care after surgery and the other received daily acupuncture intervention from the day after surgery until discharge.

“The acupuncture was delivered to each patient in their hospital room by a licensed acupuncturist from Northwestern Medicine Osher Center for Integrative Health,” explains Dr. Feingold. “The acupuncturists coordinated timing with patients and medical providers to ensure that acupuncture was not disruptive to routine medical care.”

Dr. Feingold says that she and fellow researchers wanted to answer three main questions with the ACU-Heart study:

1. Would patients embrace acupuncture during such a significant event as heart surgery?
2. Is it logistically feasible in a cardiac surgery setting to provide daily acupuncture to patients? 
3. Does acupuncture impact medical outcomes such as AFib and post-surgical symptoms such as pain, nausea, stress and anxiety?

The findings were positive on all three fronts.

“We learned that acupuncture after open heart surgery is feasible in this fast-paced environment — even in the intensive care unit the day after surgery — and was well tolerated by patients with no adverse effects,” says Dr. Feingold. “The majority of patients had no prior history with acupuncture, demonstrating their openness to receive integrative therapies after surgery. Overall, patients reported that it was a pleasant and positive aspect of their cardiovascular surgery recovery.”

She notes that some of the nurses commented that patients were more relaxed and calmer after acupuncture. “In a future study, we can fold in measuring the impact that acupuncture intervention has on the care team,” says Dr. Feingold.

From the study, the research team found that acupuncture after heart surgery was linked to:

• Lower rates of post-operative atrial fibrillation (POAF) by 58%. Patients in the study who received acupuncture had a 14% incidence of POAF compared with 33% in the standard control group.
• Reduced pain, nausea, stress and anxiety. Based on patient reporting, these surgical side effects were reduced with each acupuncture session.
• Less time spent in intensive care. Patients who received acupuncture spent about seven fewer hours in the intensive care unit than study participants who didn’t receive acupuncture.
• A reduced need for antiarrhythmic medication at the time of discharge by 68%. Approximately 10% of patients who received acupuncture were on a heart rhythm medication (amiodarone) at the time of discharge compared to 27% in the standard control group. 

“Atrial fibrillation is the most common arrhythmia impacting patients after heart surgery and comes with the increased risk of stroke, heart failure and abnormal blood pressure. Managing Afib and other postoperative symptoms is a key to achieving good outcomes in cardiac surgery,” says co-investigator Patrick M. McCarthy, MD, cardiac surgeon and executive director of the Bluhm Cardiovascular Institute. “While this is a small study, it shows significant promise and we’re excited by the idea that there’s a potential intervention that’s inexpensive, accessible, low risk and it’s well-tolerated by patients.”

Dr. Feingold and Dr. McCarthy agree that a larger, multicenter trial with patients undergoing a broader range of heart procedures is needed to better understand the impact of acupuncture on the severity and timing of POAF, as well as the post-operative physical and emotional symptoms such as pain, nausea, depression and anxiety.

“It's exciting to demonstrate the potential role of integrative therapies like acupuncture in the cardiovascular setting — including after cardiac surgery,” says Dr. Feingold. “There's more to be done, but the ACU-Heart pilot trial certainly demonstrates significant promise.”

The study was funded through a philanthropic gift from the Malkin Family Foundation and approved by the Northwestern University Institutional Review Board (#STU00201408).

B-ROLL, SOUNDBITES & PHOTOS: https://www.dropbox.com/scl/fo/wl524jvxceyuhcil88lvw/h?rlkey=3l4e4uhrl67ufqdstpy4r1owi&dl=0

STUDY LINK: Acupuncture after valve surgery is feasible and shows promise in reducing postoperative atrial fibrillation: The ACU-Heart pilot trial - JTCVS Open

CHICAGO - April 19, 2023 - A new Northwestern Medicine study published in Annals of Neurology shows neurological symptoms, findings and patterns of cognitive dysfunction differ between long COVID patients who were hospitalized during their acute infection and those who didn’t require hospitalization. Researchers studied the first 600 long-haulers who were evaluated at the Northwestern Medicine Neuro COVID-19 Clinic and discovered those initially hospitalized for acute COVID-19 pneumonia showed a broad pattern of cognitive impairment and lack of insight into their cognitive dysfunction, while non-hospitalized long-haulers mainly had difficulties with attention tasks.

“We were surprised to find that even though both post-hospitalization and non-hospitalized long-haulers report brain fog, there were marked differences in their pattern of cognitive dysfunction, which suggests distinct causes and mechanisms of long COVID in these populations,” said Igor Koralnik, MD, chief of neuroinfectious diseases and global neurology at Northwestern Medicine, who oversees the Neuro COVID-19 Clinic and is co-director of the Northwestern Medicine Comprehensive COVID-19 Center.

Researchers focused this study on the first 600 patients (100 post-hospitalization, 500 non-hospitalized) who had a documented COVID-19 infection and came to the Neuro COVID-19 Clinic either in person or via telemedicine between May 2020 to August 2021. Patients reported an average of seven neurologic symptoms due to COVID-19, with 91% experiencing more than four neurological symptoms.

NEUROLOGIC SYMPTOMS

-        81% experienced brain fog

-        70% experienced headaches

-        56% lost their sense of smell

-        55% had an altered sense of taste

-        50% experienced dizziness

Hospitalized patients had more abnormal neurologic exams (62% vs 37%) and performed worse on processing speed, attention and working memory tasks. Non-hospitalized patients had lower results in attention tasks only.

NON-NEUROLOGIC SYMPTOMS

-        86% experienced fatigue

-        69% experienced depression/anxiety

-        57% had insomnia

-        48% experienced shortness of breath

-        34% self-reported variation of heart rate and blood pressure

-        30% experienced chest pain

-        27% had gastrointestinal symptoms such as nausea, vomiting or diarrhea

Of these symptoms, only shortness of breath and chest pain were significantly more frequent in the post-hospitalization group than non-hospitalized.

DEMOGRAPHICS AND COMORBIDITIES

Both groups demonstrated significant altered quality of life in domains of cognition, fatigue, sleep, anxiety and depression compared to the U.S. normative population, but have significant differences in demographics and comorbidities.

Of the 100 post-hospitalization patients

-        Average age was 54, 58% were female, 62% were White, 18% Black, 3% Asian, and 19% Hispanic

-        Post-hospitalization patients more frequently than non-hospitalized had hypertension (39% vs 15%), high cholesterol (22% vs 13%), type II diabetes (21% vs 4%), lung diseases (16% vs 4%) and cardiovascular diseases (10% vs 2%)

Of the 500 non-hospitalized patients

-        Average age was 45, 66% were female, 77% were White, 8% were Black, 4% were Asian and 12% were Hispanic   

-        Non-hospitalized patients were more likely than post-hospitalization patients to suffer from depression/anxiety prior to COVID-19 (40% vs 9%)

The demographic, comorbidities, clinical and cognitive differences highlighted in the study suggest distinct etiologies of long COVID in hospitalized and non-hospitalized patients, warranting targeted interventions.

“For patients previously hospitalized with COVID-19, it’s possible they suffered diffuse brain damage, which could have been caused by a combination of hypoxemia, cytokine storm, multi-organ failure, or encephalopathy which may not be visible on brain CT or MRI. This is consistent with the broad cognitive dysfunction harbored by these patients,” said Dr Koralnik. “Conversely, the female predominance of non-hospitalized patients suggests an autoimmune etiology of long COVID in this population, perhaps triggered by viral persistence. Indeed, women are more likely than men to develop autoimmune diseases.”

Of the 600 patients involved in the study, 43% were vaccinated and all but one patient became infected before vaccination. At the time of their clinic visit, patients felt approximately 60% recovered back to their pre-COVID baseline.

Northwestern Medicine researchers plan to continue studying long COVID over the adult lifespan, comparing patients 18-44 years old, 45-64 years old, and over 65 years old to determine if there are differences between those groups and if either group was more affected at a specific time of the pandemic by different circulating strains.

“Long COVID occurs in approximately a third of COVID-19 survivors and is now the third leading neurologic disorder in the United States. Long COVID has a significant detrimental effect in patients’ quality of life and has pushed an estimated one million people out of work in the U.S.,” said Dr. Koralnik. “Considering the large number of people impacted by long COVID and the continuing potential for infection leading to persistent and potentially disabling neurological symptoms, there should be a greater emphasis on funding research on the root causes of long COVID leading to clinical trials in the U.S.”

To date, the Neuro COVID-19 Clinic has treated nearly 2,000 long-haulers. For more information, visit nm.org and to schedule an appointment, please call 312.695.7950.

CHICAGO – March 15, 2023 – Cancers of the lung are the leading cause of cancer-related deaths in the United States with more people dying of lung cancer than colon, breast and prostate cancers combined. For the second time at Northwestern Medicine, surgeons have successfully performed a double-lung transplant on a patient with stage 4 lung cancer who was being considered for hospice. The treatment option is now available for select patients with stage 4 lung cancers confined to the lungs in a first-of-its-kind clinical program at Northwestern Medicine called Double Lung Replacement and Multidisciplinary Care (DREAM).

“These are patients diagnosed with some forms of lung cancer that have spread within the lung, are out of treatment options and have limited time to live,” said Ankit Bharat, MD, chief of thoracic surgery and director of Northwestern Medicine Canning Thoracic Institute. “In this unique program we will include select patients with some forms of lung cancer that are limited to the lungs for the consideration of double-lung transplant if conventional or experimental treatments have failed. The purpose of DREAM is to provide the most comprehensive multidisciplinary care for these complex patients.”

“We’re excited to formally launch this unique multidisciplinary program that will include highly experienced specialists across disciplines such as thoracic surgery, pulmonary, and oncology, to help some of the most hopeless patients,” said Rade Tomic, MD, pulmonologist and medical director of the Northwestern Medicine Canning Thoracic Institute Lung Transplant Program.

On September 25, 2021, at the age of 54, Albert Khoury from Chicago, Ill., became the first patient with stage 4 lung cancer to receive a lung transplant at Northwestern Medicine. In early 2020, Khoury was working as a cement finisher when he developed back pain, sneezing, chills, and a cough with mucus. At first, Khoury thought it was COVID-19, but then he was diagnosed with lung cancer and ended up in the intensive care unit on a ventilator when chemotherapy treatments failed. As hospice care was being considered for Khoury, Northwestern Medicine surgeons determined that because his tumor was localized to the chest completely encasing both lungs and hadn’t spread to other parts of his body, he was a candidate for a double-lung transplant. Eighteen months after receiving the lifesaving surgery, Khoury still has no signs of cancer left in his body and has returned to work.

“My life went from zero to 100 because of Northwestern Medicine,” said Khoury. “You didn’t see this smile on my face for over a year, but now I can’t stop smiling. My medical team never gave up on me.”

As Khoury was receiving his transplant in September 2021, Tannaz Ameli of Minneapolis, Minn., was struggling with a lingering cough. By January 2022, the retired nurse went to a large health system in Minnesota where they confirmed she had stage 4 lung cancer. When chemotherapy treatments didn’t help and hospice was recommended, Ameli’s husband reached out to the Northwestern Medicine Canning Thoracic Institute’s Second Opinion Program. Because Ameli’s cancer was confined to the lungs and hadn’t spread to other parts of the body, the 64-year-old was listed for a transplant and received new lungs within 10 days on July 13, 2022.

“I begged my doctors in Minnesota to consider a lung transplant, but they wouldn’t do it. Luckily, my husband refused to give up and pushed for a second opinion,” said Ameli. “When I came to Northwestern Medicine, the first thing Dr. Bharat told me was, ‘I think we can make you cancer-free,’ and he delivered on those words. If you or your loved one has complex conditions such as lung cancer, Northwestern Medicine is the place to be. Everyone is amazing and I can’t thank them enough for saving my life.”

Khoury and Ameli didn’t require any further cancer therapy after transplant. 

“Innovation and research have always been a foundational cornerstone at Northwestern Medicine and we’re committed to continually improving the field of transplantation,” said Satish Nadig, MD, PhD, transplant surgeon and director of the Northwestern Medicine Comprehensive Transplant Center. “Liver transplantation for cancer is commonplace, and while it’s not suitable for all, it’s highly effective in many. Further, transplantation for metastatic cancer to the liver, from the colon, for example, is now past proof-of-concept. It will be exciting to better understand whether we can use transplant principles for certain lung cancer types that have only spread within the lungs.”

Northwestern Medicine surgeons were the first to perform double-lung transplants on COVID-19 patients in the United States, and in the largest single-center series published to date, the post-transplant survival at one year for those patients was above 90%, exceeding national metrics. Using lessons learned from pioneering COVID-19 lung transplantation, Northwestern Medicine surgeons developed a novel surgical technique to clear the cancer during surgery while minimizing the risk of spread that has plagued prior such attempts at other hospitals.

“While lung transplantation is an accepted indication for certain forms of lung cancer by national organizations, it’s infrequently performed due to the concerns of recurrence following surgery. Unlike the conventional technique of sequential transplants, this innovative technique involves putting the patient on full heart and lung bypass, delicately taking both cancer-ridden lungs out at the same time along with the lymph nodes, washing the airways and the chest cavity to clear the cancer, and then putting new lungs in,” said Dr. Bharat. “These patients can have billions of cancer cells in the lungs, so we must be extremely meticulous to not let a single cell spill into the patient’s chest cavity or blood stream. We believe this technique can help reduce the risk of recurrence, which we learned through our experience with pioneering COVID-19 lung transplants.”

“Similar to our experience with COVID-19 lung transplantation, when it comes to donor lung availability, we do not anticipate causing any disadvantage to the non-cancer patients awaiting lung transplant,” said Dr. Tomic. “We plan to mitigate any issues with donor lung availability using our newly launched 'lungs in a box' program, where our surgeons can repair damaged lungs and successfully use them for transplant.”

The outcomes of the program’s first 75 patients will be tracked in a new research registry also called DREAM (Double Lung Transplant Registry Aimed for Lung-limited Malignancies – a prospective observational registry study for patients undergoing lung transplantation for some forms of medically refractory lung cancer confined to the lungs) available on ClinicalTrials.gov. The research registry is focused on the outcomes of the treatment intervention. Participation in the research registry is voluntary. A patient may receive a double-lung transplant as part of the DREAM clinical program, without enrolling in the DREAM research registry.

“Encouraged by our first two patients, the goal of following these registry participants is to maintain close follow-up care by our multidisciplinary team and demonstrate good outcomes while learning new insights about lung cancer,” said Young Chae, MD, medical oncologist at Northwestern Medicine.

Patients interested in being evaluated for a lung transplant can contact the referral line at 844.639.5864. For more information about Northwestern Medicine’s lung cancer and lung transplant programs, as well as advanced therapies, visit nm.org.  

CHICAGO -  After his second cardiac event in five years, Joseph Mulligan was not surprised when his Northwestern Medicine cardiologist, James Flaherty MD, recommended an implantable cardioverter defibrillator (ICD) as a safeguard to help keep him alive if he were to have a sudden cardiac arrest. At 84 years old, the resident of South Bend, Ind., knew many people with pacemakers and expected, like his friends, he would need a traditional transvenous defibrillator implant with thin wires (leads) threaded directly into his heart and veins to deliver electric therapy to his heart if needed.

Then his medical team presented him with a unique option – Mulligan was a candidate for a clinical trial to test the safety and efficacy of a first-of-its-kind extravascular implantable cardioverter defibrillator (EV ICD). The Medtronic EV ICD is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest, while avoiding certain risks of traditional, transvenous ICDs.

“The EV-ICD involves placement of a special lead that is tunneled under the sternum, so that the lead is not in the heart, but is very close to the outside of the heart,” says Bradley P. Knight, MD, medical director of electrophysiology at Bluhm Cardiovascular Institute. “This allows for lower energy and smaller battery requirements to defibrillate the heart in the event of a cardiac arrest and for pacing of the heart to treat slow heart rates or to terminate fast ventricular tachycardias.”

Northwestern Medicine Bluhm Cardiovascular Institute was the only site in Chicago and one of only 46 sites worldwide to participate in a pivotal study of the device. The results of the trial were presented at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and published in The New England Journal of Medicine.

Worldwide, hundreds of thousands of ICDs are implanted in patients every year to treat dangerously fast heart rhythms. With traditional transvenous defibrillators, the lead is inserted through a vein and attached to the heart leaving the lead under constant stress from the heart beating and movement of the upper body, potentially causing breakage of the lead or blockage of the vein. A totally subcutaneous defibrillator is currently available as an alternative to a transvenous defibrillator, but the device is very large and is unable to pace the heart. The goal of the EV ICD system is to provide the benefits of current transvenous ICDs, but with a smaller device, greater device longevity and without placing leads in the heart or vasculature.

“By positioning the leads outside of the heart, there is less risk of long-term complications associated with leads in the heart and veins, such as the narrowing, blockage or compression of a vein and risks for blood infection,” says Dr. Knight, a co-author on the study.

The EV ICD Pivotal study enrolled 356 patients in 17 countries across North America, Europe, the Middle East, Asia, Australia and New Zealand. Participants in the trial, like Mr. Mulligan, received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing and back-up pacing therapies, with this single implanted device.

The trial met its primary objectives: defibrillation therapy effectiveness at implant was 98.7%. This reflects a greater defibrillation efficacy for the EV ICD than historical transvenous ICD studies, and comparable efficacy to the subcutaneous ICD despite EV ICD’s smaller device size. The study also exceeded its safety endpoint: at six months, 92.6% of patients were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death.

“The EV-ICD is a revolution in implantable defibrillator technology that addresses the limitations of our existing therapies that have been available for several decades,” says Dr. Knight. “With the promising data from this trial, we have an opportunity to evolve ICD technology in a safe, effective manner and improve this lifesaving therapy.”

For Mulligan, now 86 years old, the option to enroll in the clinical trial is one he is thankful for as he continues to lead a very active life with the EV ICD as a safety net.

“I feel terrific and I’m grateful to have the advantage of having this device, which I know is keeping me alive longer than I should be,” says Mulligan, an alum of Notre Dame who remains active with the university as president of class of ’59 and a member of the Notre Dame community choir. “The whole process was very easy – I was only hospitalized overnight, and my scar has already almost completely disappeared.”

Worldwide, the EV ICD system is investigational and not yet approved for sale or distribution. Medtronic has received FDA approval for a Continue Access Study, and patients in the pivotal study will continue to be followed until Medtronic receives regulatory approval for the EV ICD system in the United States. The clinical trial was funded by Medtronic; ClinicalTrials.gov number, NCT04060680. 

To learn more about cardiovascular clinical trials at Northwestern Medicine, visit the Bluhm Cardiovascular Institute – Clinical Trial Unit.

Bluhm Cardiovascular Institute is an innovative powerhouse in developing the latest, safest advances in cardiovascular care. Anchored in downtown Chicago, it has expanded and integrated into eight Northwestern Medicine hospitals, most recently bringing advanced cardiovascular services to the south suburbs at Northwestern Medicine Palos Hospital. Consistently recognized as one of the top cardiology and cardiac surgery programs in the country, Bluhm Cardiovascular Institute at Northwestern Memorial Hospital is ranked eighth in the country by U.S. News & World Report in the annual “America’s Best Hospitals” rankings. For more information, visit heart.nm.org.

A first-of-its-kind trial, funded by the National Cancer Institute (NCI), a part of the National Institutes of Health, will test whether a telehealth-based intervention that addresses all three behavioral risk factors at once can modify cancer patients’ lifestyles to improve their outcomes. The trial will recruit 3,000 participants at 11 Northwestern Medicine hospitals.

Northwestern's Program for Scalable TELeheaLth Cancer CARe (STELLAR) is part of a new initiative that is funding four NCI Telehealth Cancer Research Centers of Excellence, and is supported by the Cancer Moonshot, a White House initiative first launched in 2016 and reignited by President Biden in 2022 to accelerate the rate of progress against cancer. Northwestern will receive $5.5 million in funding over five years.

“These risk behaviors are the same for most chronic diseases, which is important because many cancer patients are more likely to die from cardiovascular diseases than from their cancer,” said project leader Bonnie Spring, a professor of preventive medicine at Northwestern University Feinberg School of Medicine, program co-lead for cancer prevention at the Robert H. Lurie Comprehensive Cancer Center at Northwestern Medicine  and director of the Center for Behavior and Health at Feinberg.

Spring’s center has already developed evidence-based, technology-assisted telehealth interventions to separately treat obesity, smoking and lack of physical activity.

“Nothing like this exists,” Spring said. “Over the years, we have developed separate treatments for these risk behaviors. Now we are putting them together. That’s an efficiency. Ordinarily it would be burdensome and expensive to deliver a treatment for even one of these risk behaviors." 

The project reduces the cost of treatment by training bachelor’s-level ‘health promotionists’ to coach patients under the supervision of clinical health psychologists. Physicians and nurses don’t have time to treat these behaviors, Spring said, and even if they did, the cost would be much higher.

Patients who smoke or are obese add $124.3 million per year to the cost of cancer treatment at Northwestern Medicine, Spring said. These costs accumulate because obesity adds $3,216 per person per year to medical expenses for cancer survivors, and Northwestern’s 11 hospitals treat 27,024 patients with cancer and obesity per year. The cost of overcoming first-line treatment failures caused by smoking is $10,678 per patient, and Northwestern treats 3,500 cancer patients who smoke in a single year. 

Participants are coached remotely by telephone and trained to use an app that tracks their behaviors. They self-report their diet and smoking, stand on a Wi-Fi scale and wear a Fitbit. The data are sent to their coach electronically, so when they have a bi-weekly coaching call, the coach “is up to speed” on how the person is doing, Spring said.

“If they are not losing weight, the coach can see what is causing it,” Spring said. “What high-calorie foods are they eating? Are they eating too late at night? Are they inactive? It’s what makes the coaching very efficient and personalized."

The remote telehealth aspect is critical to success, Spring said. “That’s important because we think this may be a way to reach more underserved people who can't access treatment because they live far away, work multiple jobs, don't have reliable transportation, can't get childcare or can't get time off work.”

The data are integrated into the patient’s electronic health record, so the cancer team is kept updated.

“This enables the team of care providers to encourage the patient to make healthy behavior changes,” Spring said. “It’s giving these doctors a service they all think is valuable, but they’ve not had time or reimbursement to offer it.”

The pandemic forced most fields of health care to try telehealth, Spring said. 

“Not surprisingly (to us), telehealth treatments have generally been effective and seem to have enabled underserved patients to access care more easily,” Spring said. “Because it’s always tempting to regress back to old ways, we now need to establish a strong research evidence base about whether telehealth works for cancer care. That’s how to improve the standard of cancer care and to make it more equitable. And that’s what the four NCI Telehealth Cancer Research Centers of Excellence will do, and why they’re so important."  

STELLAR integrates Spring's obesity treatment with smoking and inactivity treatments developed by project co-leads, Brian Hitsman and Siobhan Phillips, both associate professors of preventive medicine at Northwestern. Co-lead Sofia Garcia, associate professor of medical social sciences at Northwestern, contributed procedures to incorporate a patient’s data into the electronic health record. Hitsman, Phillips and Garcia are all members of the Lurie Cancer Center at Northwestern.

Using the app on Apple Watch and an accompanying app on iPhone, patients in the trial will be able to target blood-thinning medication use for a limited period of time and only in response to a prolonged episode of AFib, thus creating personalized care unique to each patient.

“If proven effective, this new treatment paradigm will fundamentally change the standard of care for the millions of Americans living with AFib,” said principal investigator Rod Passman, MD, director of the Center for Arrhythmia Research and a professor of medicine in the division of cardiology at Feinberg.

“Many of these patients are on blood thinners for the rest of their lives even if they have infrequent episodes of atrial fibrillation,” Passman said. “If we can show this strategy is equally protective against stroke and reduces bleeding, that could save lives, reduce cost and improve quality of life.”  

For eight years, Passman has been studying solutions to end the standard “one-size-fits-all” practice of prescribing lifelong blood thinners (anticoagulants) to everyone with AFib. 

The trial secures Northwestern as the world leader in wearable devices for treating atrial fibrillation. 

While it is estimated that between 2.5 and 5 million Americans are living with AFib today, that number is estimated to grow to 12.1 million by 2030. Worldwide, the estimated number of individuals with AFib in 2010 was 33.5 million, according to a 2013 study.

Targeting when to use blood thinners to limit reliance

AFib is a heart rhythm disorder characterized by fast and irregular heartbeats from the upper chambers of the heart. People with AFib have increased risk of stroke, so many are continuously treated with blood-thinning medication to reduce that risk. But this treatment also raises the risk of bleeding, according to Passman, and balancing the risks and benefits can be challenging for both patients and physicians. 

However, some patients with AFib have infrequent episodes of irregular heart rhythm either on their own or as the result of medications or procedures. Current evidence suggests the risk of stroke increases in the weeks following an episode of AFib then returns to a baseline, raising the possibility of intermittent blood-thinner treatment. 

Since many individuals have no symptoms during an episode of AFib, the new trial will employ Apple Watch to monitor heart activity and notify patients when they’re entering an episode. 

When notified, patients will take blood-thinning medication for a few weeks during the high-risk window for stroke and can discontinue if they do not have another episode. This “pill-in-pocket” approach could protect patients against stroke while reducing bleeding events and the cost of Afib treatment, Passman said. 

“We think advances in technology will allow us to personalize this care,” Passman said. “Why should patients expose themselves to the risk and cost of these drugs when they may not be benefiting?”

More about the trial:

The seven-year trial will recruit 5,400 patients, randomizing them to receive either the current standard of care or treatment directed by the app on Apple Watch. The trial will also examine whether the app can reduce major bleeding events compared to continuous therapy. 

Secondary aims include measuring patient satisfaction and health care resource utilization. Importantly, the trial will reveal important information about AFib no matter the findings, according to Passman. 

“While most data suggest the atrial fibrillation rhythm itself causes the stroke, there’s an alternative hypothesis that the risk remains even when the rhythm itself goes away,” Passman said. “If this strategy is not equally effective, then perhaps we should reconsider whether the rhythm of the heart causes stroke or is simply a marker for some underlying mechanism.”

This grant application was administratively supported by the Northwestern University Clinical and Translational Sciences (NUCATS) Institute, the Bluhm Cardiovascular Institute’s Clinical Trials Unit and the Trial Innovation Network.

Northwestern is the lead study site. Partnering institutions include Johns Hopkins, Stanford University and University of California at San Francisco. 

CHICAGO – A new study published in Annals of Clinical and Translational Neurology* looked at the evolution of neurologic symptoms in non-hospitalized COVID-19 long-haulers at the Northwestern Medicine Neuro COVID-19 Clinic and discovered most long-haulers continue to experience symptoms such as brain fog, numbness/tingling, headache, dizziness, blurred vision, tinnitus and fatigue on average of 15 months after disease onset. Researchers analyzed patients 6-9 months after their initial visit to the Neuro COVID-19 Clinic and discovered heart rate, blood pressure variation and gastrointestinal symptoms increased in long-haulers, while loss of taste and smell decreased overall. The findings are a follow-up to the Northwestern Medicine research team’s March 2021 study that discovered 85% of long-haulers experience four or more neurologic symptoms which impact their quality of life, and in some patients, their cognitive abilities.

“This new study is novel and reports the longest follow-up period of neurologic symptoms impacting non-hospitalized patients suffering from long-COVID anywhere in the world,” said Igor Koralnik, MD, chief of Neuro-infectious Diseases and Global Neurology at Northwestern Medicine, who oversees the Neuro COVID-19 Clinic. “We were surprised by the persistence of most of the debilitating neurologic symptoms of our patients, and by the late appearance of symptoms that suggest dysfunction of the autonomic nervous system.”

Researchers focused this study on patients evaluated initially between May and November 2020 who had mild initial COVID-19 symptoms (ex: transient cough, sore throat) and never required to be hospitalized for pneumonia or low oxygen levels. Of the 52 patients who completed the follow-up study:

- Average age was 43

- 73% were female

- 77% received the COVID-19 vaccine

- Most continued to experience neurologic symptoms, fatigue, and compromised quality of life 11-18 months after disease onset, an average of 15 months

Overall, there was no significant change in the frequency of most neurologic symptoms between first and follow-up appointments including brain fog (81 vs 71%), numbness/tingling (69 vs 65%), headache (67 vs 54%), dizziness (50 vs 54%), blurred vision (34 vs 44%), tinnitus (33 vs 42%) and fatigue (87 vs 81%).

While loss of taste (63 vs 27%) and smell (58 vs 21%) decreased overall, heart rate and blood pressure variation (35 vs 56%) and gastrointestinal symptoms (27 vs 48%) increased at follow-up.

Patients reported improvements in their recovery, cognitive function, and fatigue, but quality of life measures remained lower than the average population of the United States. Seventy-seven percent of the patients had been vaccinated for COVID-19, but the vaccine didn’t have a positive or detrimental impact on cognitive function or fatigue.

“Vaccination didn’t cure long COVID symptoms, but didn’t worsen them either, which is a reason given by some long-haulers for not getting vaccinated,” said Dr. Koralnik. “As new variants emerge and the number of patients impacted by long COVID rises, we’re now focusing our research on understanding the root cause of long COVID. We’re also devising interventions to improve the management of those patients and find the best treatment options for them.”

To date, the Northwestern Medicine Neuro COVID-19 Clinic has treated nearly 1,400 long-haulers from across the U.S. For more information, visit nm.org and to schedule an appointment, please call 312.695.7950.