The Patient Was…

A recent post on this blog was concerned with the role of technology in current medical care, and the potential drawbacks of overreliance on technological advances to the neglect of non-technical clinical processes.

In the current posting, I want to focus on so-called Remote Monitoring, a type of technological advance that has generated a torrent of interest and is playing a major and still growing role in the diagnosis, treatment, and follow-up of patients, especially those with cardiovascular disease.

Monitoring itself refers to the observation and review of something, in our case vital patient data, over a period of time. Remote monitoring uses technology to monitor patient data from a distance, away from the actual source of data generation.

Exact numbers are hard to come by, but it is clear that millions of Americans and millions more people worldwide are using (or at least have purchased) consumer-focused remote monitoring devices, usually for tracking what are generally accepted as measures of “fitness.” Consumer-focused monitoring is different from medically-focused remote monitoring, which is prescribed or instituted by medical personnel and used in the diagnosis and ongoing management of disease. While consumer-focused remote monitoring depends largely on external, wearable devices, medically-focused monitoring may employ invasive technologies and devices.

The concept of remote monitoring makes absolute sense. After all, the amount of time a patient spends in the doctor’s office or the clinic is infinitesimal compared to the that spent away from the office or clinic. It is entirely unreasonable to expect that the brief time spent with the doctor will reveal all there is to learn about a patient’s condition. Changes in every vital sign are normal and expected over time, and changes indicating abnormalities or diseases often occur randomly, at irregular intervals, and under conditions not encountered during a visit to the doctor. It seems not only prudent, but essential, to monitor patients’ physiological responses as they go about their lives.

So, what’s the problem? Why is the whole field of remote monitoring so controversial?

One major concern is the accuracy of the devices used to record and analyze the data being collected. While medical devices require approval by the FDA (Food and Drug Administration), so-called consumer wearables  —   watches, rings, bracelets, skin patches, vests, etc.  —  do not require government approval. Consumer-focused devices can claim to provide general health information, and to track fitness and wellness variables; as long as they do not claim to be health devices or provide health benefits, consumer wearables avoid the necessity of official approval.

The problem with many such consumer devices is lack of accuracy and clarity of the data that is collected and the information that is reported. Blood pressure readings may be inaccurate, heart rhythm disorders may be reported incorrectly or fail to be recognized. Graphic recordings may be so distorted that the data are essentially useless. And false indications of abnormalities can create fear and anxiety in consumers, leading to unnecessary medical encounters. There is little coordination among manufacturers of devices, so terminology and capabilities may not be standardized, and device interconnectedness is often lacking.

Medical monitoring is generally more complicated than consumer-focused monitoring. The data collected are often more important, because they involve illness and disease rather than general fitness and wellness. Accuracy and timeliness of data are certainly more important, because decisions with serious consequences may depend on them. And medical monitoring is increasingly becoming invasive, meaning that data sensors and transmission capabilities are implanted within the body, carrying risks not shared by external devices.

Among the early invasive, implantable devices were rather simple electrodes that recorded electric signals generated within the heart. Thus, irregularities of heart rhythm (arrhythmias) could be detected. Timely treatment could be delivered if the data were recorded and analyzed correctly, and seen by medical personnel, in real time, with the ability to prescribe or actually deliver appropriate therapy. It should be immediately apparent that well-organized systems and protocols are necessary to ensure the value and benefits of such monitoring.

As devices became more sophisticated and powerful, new capabilities were imagined and developed. Arrhythmias could not only be diagnosed by the technology, but corrective measures, like electrical shocks, could be delivered to the patient by the same device that recorded the abnormality. In certain situations, the device could not only deliver a corrective electric shock to treat a dangerous arrhythmia, but could also act as a pacemaker to take over and control the heartbeat.

More recently, invasive remote monitoring has been employed in therapeutic areas beyond cardiac rhythm disturbances. The major current target is congestive heart failure, a serious condition in which the heart is incapable of pumping adequate amounts of blood around the body; fluid backs up into the lungs interfering with oxygen delivery and raising pressures in pulmonary blood vessels and the veins returning blood from around the body to the heart. It is estimated that over six million Americans suffer from heart failure, and as the population ages, more cases are expected. Although there are many medications approved to treat the condition, and even specialized devices are sometimes implanted to support the work of the heart, the prognosis remains serious.

Based on the assumption that earlier recognition of worsening of heart failure, in patients already diagnosed with the condition, could lead to reductions in hospitalizations and further deterioration of cardiac function, new monitoring devices are under development. Since clinical symptoms and signs of worsening heart failure often occur too late to institute preventive measures, it is theorized and hoped that early recognition of increased pressure in the blood vessels carrying blood to the heart and in pulmonary blood vessels themselves could lead to earlier treatments that would ward off deteriorating performance of the heart. Thus, pressure sensors are being implanted in both the inferior vena cava, the large vein feeding blood into the right side of the heart from where it goes directly to the lungs, and in the main pulmonary artery itself. Preliminary results indicate that early recognition of elevated pressures in the blood vessels can lead to early treatment and prevention of worsening heart failure.

Proponents of using these devices point to better clinical outcomes and reduced costs due to fewer hospitalizations. I haven’t heard much discussion, however, of the costs in equipment, technology, and personnel to manage the data centers that are required to make these interventions effective.  And wouldn’t it be better to discover noninvasive monitoring techniques that avoid the risks and costs of implanting these devices? Even better, perhaps our more non-technical experts could unmask currently unrecognized clinical symptoms and signs that would indicate early deterioration in heart function and allow prompt therapeutic intervention.

By now, you probably recognize that I favor non-invasive, non-technical, more clinical and personal approaches to caring for patients. I am in awe of some technological advances, and have absolute admiration for the people who imagine, create, and develop life-saving technology. My plea, though, is for continuing improvement in clinical medicine, enhancing clinical expertise, and maintaining the uniquely human quality of medical care.