Futuristic Cardiac Monitoring Devices

Treating patients with heart disease has never been easy – but, surprisingly, in the past 10 years, it’s gotten even more difficult.

“Treating the average cardiac patient is more complicated today than it was a decade ago,” reported David L. Scher, MD, a cardiologist, clinical associate professor of medicine at Penn State College of Medicine, founder of DLS Healthcare Consulting, and chair of the Healthcare Information and Management Systems Society’s mobile health roadmap task force. “Patients are living longer and have more comorbid chronic diseases than in the past.”

Other differences in treating patients today versus a decade ago involve factors most healthcare providers have no control over – time with patients. Fortunately, however, there is some good news on the patient care horizon – and it is wireless in nature. The cardiac care devices available today are nothing short of remarkable.

Monitoring Inpatients 24/7

The most complex cardiac care patients are hospitalized inpatients. According to the ACADEMIA study, published in the journal Resuscitation in 2004, 84% of hospital patients who have developed cardiac arrest had instability within the 8-hour window preceding the event. For patients with unexpected clinical deterioration, delayed intervention is associated with increased morbidity and mortality. Responding quickly and effectively to early warning signs reduces mortality by 75% – and can reduce costs by 40%.

Transitioning Children to Adult Care

Technology has made amazing leaps and bounds in the healthcare arena; there’s no doubt it has helped advance patient care. But there’s just no replacement for human contact in healthcare – just ask MarlaJan DeFusco, BSN, RN, CPN.

DeFusco was born with a congenital heart defect called tetralogy of Fallot, and had her first open-heart surgery when she was only 6 months of age. Over the next 5 years, she was on multiple cardiac medications, had numerous catheterizations and three more heart surgeries. When DeFusco was 24, her pediatric cardiologist informed her she would soon need to leave the children’s hospital and begin seeing an adult cardiologist once she passed her 25th birthday.

“I wasn’t thrilled,” DeFusco stated. “I had been at CHOP all my life. “It was so different,” she remembered. “Even at the age of 25, this new building was scary to me. I knew then that there had to be a better way to transition children to adult care settings.”

Flash forward. DeFusco’s passion and love for the nurses at CHOP inspired her to become first an RN, then an BSN. “After graduation, she joined the nurses who helped save her life, working for six years as a surgical/trauma and apheresis transfusion nurse at CHOP. In 2010, she came full circle, joining CHOP’s cardiac ICU nursing team.

When she heard about a new project called “Flip the Clinic,” funded by the Robert Wood Johnson Foundation (RWJF), she recognized it as a chance to make her dream a reality. Each “flip” is an actionable idea for change, and RWJF helps bring patients and clinicians together to co-create simple, pragmatic, and inexpensive changes within the healthcare delivery system.

SEE ALSO: Pulmonary Hypertension in Children

DeFusco’s proposal, titled “Lost in Transition,” described the issues pediatric patients face as they transition to adult care. DeFusco outlined the need for a specific training program to smooth the transition, including designating one person (called an “assigned transition navigator”) to serve as the point person for patients, families, and clinicians. The goal: to support young people as they find their footing in a brand-new system of care.

“Some people really ‘slip through the cracks’ when they leave the pediatric setting,” she commented. For example, there was the 47-year-old who was admitted to the ED in heart failure. “He told us, ‘I have a scar on my chest from a heart surgery when I was young.’ Aside from this, he knew nothing else about his condition.”

RWJF did choose her proposal as a pilot project and is implementing it at Cincinnati Children’s Hospital Medical Center. In November 2015, DeFusco attended the RWJF’s “Flip the Clinic” summit in Denver, where she met the CCHMC people they had assembled to work on Flip 72.

“By 2017, this role should be a reality in Cincinnati. In my opinion, the assigned transition navigator should be an RN,” DeFusco acknowledged. “And, while every patient is different and may have various developmental needs, it would be ideal to begin the education and transition process when patients are in their early teens to give both patients and caregivers years to preparebefore they actually make the transition.” She hopes she can one day hold the job title of nurse navigator for a transition program – ideally, at the healthcare facility she loves most, CHOP.

The study authors noted the two most important predictors of adverse events are respiratory rate and heart rate, emphasizing the importance of continuous monitoring of vital signs as a means of detecting patient deterioration.

No Longer a Pipe Dream

Fortunately, continuous monitoring is no longer a pipe dream. There are devices currently in use that allow for continuous wireless monitoring of a patient’s heart rate, respiration, and body movement – and some even function without cumbersome wires or sticky tape being applied to a patient’s arm or torso. One company offers a notebook-like sensor that is placed under the mattress of the hospital bed (so patients might not even realize it’s there). Data is sent to computer monitors placed in critical locations and hand-held devices carried by nurses, making them aware when a patient begins a downward health spiral. A nurse who notices data trending downward will know to closely monitor the patient in the hours that follow, allowing them to intervene more quickly if a rapid response becomes necessary.

Other companies offer a platform consisting of hardware, software, and services that are merged with the healthcare facility’s monitoring equipment and EMR system. Historically, if an off-site cardiologist wanted a report on the changes in a patient’s heart rhythm, he or she would have to assess these measurements verbally over the telephone, guessing at the validity of the waveforms being described by another member of the care team, or struggle to read an ECG that was faxed or sent via PDF (both of which can be hard to decipher).

With today’s interoperable technologies, the data appear on the off-site cardiologist’s phone or tablet in the exact same format as at the patient’s bedside. Cardiologists can access information pertaining to the patient’s temperature, blood pressure, CT scans, ultrasounds, labs, radiographs, and medications, leading to a faster and more precise diagnosis (thereby improving overall patient care and safety).

Monitor Roving Patients, Too

Not all cardiac patients require a hospital stay, but they might need frequent monitoring to ensure continued good health. Fortunately, there are a host of devices on the market that can ensure these mobile cardiac patients stay on the go, while receiving the same level of care – via continuous monitoring – as a hospital inpatient would.

If you’re conjuring up images in your mind of bulky monitors, think again. Most of today’s devices involve wearable, wireless, “peel-and-stick” sensors that are no more intrusive than a Band-Aid would be underneath a person’s shirt; or they might require users to press on their smartphone or tablet with their finger (or rest these devices on their chest) for 30 seconds to capture an ECG.

Many existing devices link to services that provide expert ECG analysis by either board-certified cardiologists or cardiographic technicians. Users can instantly know whether their ECG is normal, or if atrial fibrillation is detected. Some devices are equipped to monitor the interactions and effects of other medications, alcohol, and caffeine on heart patients, allowing them to make more informed decisions regarding their usage.

Flawless Medication Management

As anyone who takes multiple medications each day can attest, knowing whether or not you took your pill is not an easy question to answer – hence, the proliferation of pill-sorting devices in drug stores. Even with these tools, an estimated 50% of patients do not take medicines as they were prescribed. Not only does this limit the therapeutic effectiveness of medications, it results in more than $100 billion in avoidable healthcare costs that arise from the unnecessary escalation of treatments.

Now, imagine a tiny, ingestible sensor (slightly larger than a grain of sand and costing the manufacturer less than a penny per pill) that you swallow along with your medication. The sensor is comprised primarily of silicon and covered with copper and magnesium, so that when it hits the patient’s stomach acids, a chemical reaction occurs, activating the sensor. A unique, time-stamped digital signal is then sent to a patch worn on the patient’s torso. The patch stores this number (which contains the exact time of pill ingestion), and this data is then wirelessly transmitted to a smartphone application, which in turn can be sent to a healthcare provider or other caregiver.

The sensor, which has already recorded which medication was ingested (and at precisely what time), then provides concurrent information about the patient’s activity and rest patterns, body temperature, and related heart rate. “What is unique is that you can view the patient data in the context of how effective a prescribed medication might be for that person,” Scher commented.

For example, if a patient is taking a cardiac medication to decrease their heart rate, you can tell if the patient’s heart rate is slow due to inactivity (if the patient is not taking any steps at the moment), or if it has remained slow despite a patient’s vigorous physical activity (if the patient is demonstrating brisk walking, running, or other movement).

These ingestible devices have the power to improve the real-world effectiveness of medicines in all community settings, thereby improving the outcomes for patients. They also have the potential to speed clinical trials and improve the data that is derived from them.

Clinical Studies Needed

“When you describe some of these existing technologies to patients, they say, ‘Wow, that will be really cool,'” Scher commented. “And I say, ‘Will be? It’s already here!’ They aren’t aware of the amazing devices for sale right now. They have no idea how much real-time monitoring is taking place today.”

The biggest barrier to wide-scale adoption and use of these tools is the lack of financial commitment to their utilization by payers. “Regulatory agencies and insurers are not keeping pace with technology,” Scher reported. “There has recently been Medicare approval for remote monitoring with these devices; however, it is not enough to cover the expense of these devices, nor is there incentive to use them. “In addition, only one physician can bill for the monitoring device,” Scher continued. “Yet a patient with co-morbidities has various specialties monitoring different things. We are programmed as a culture to treat diseases, instead of focusing on wellness and prevention. This is a different mindset than you find in most developed countries.”

Another problem, according to Scher, is that the companies developing these products don’t want to invest their resources in clinical studies. “They hear ‘study’ and they think ‘long-term’ and ‘horribly expensive’ – but it doesn’t have to be,” he informed. “The bottom line is, it’s necessary. Clinicians and their patients need and deserve concrete data to convince insurers that these devices are worth the healthcare dollars spent. Once you can prove they keep patients out of the hospital, you’ll see insurers providing coverage. ”

Anne Collins is on staff at ADVANCE. Contact: [email protected]

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