Heart Attack Recovery: Autonomous Device in Development

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A visionary depiction of ACIS, the Independent, Feedback-Driven Intervention System being crafted to aid patients’ recuperation from myocardial infarction and intense cardiac insufficiency. The ultimate appearance of the finished product remains uncertain.(Image credit: Courtesy of NTT Research, Inc.)ShareShare by:

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Hospitals might soon depend on an “independent” apparatus to assist patients in their convalescence following heart attacks. This apparatus would administer treatments to the patient, gather information on the individual’s bodily responses, and subsequently modify their prescriptions to ensure stabilization of the patient within constraints defined initially by their physician.

Such is the concept behind the Autonomous Closed-Loop Intervention System (ACIS), a creation being worked on by researchers at NTT Research, a division of the worldwide tech firm NTT. The apparatus has seen usage in studies involving creatures, although its effects on human subjects remain unexplored.

The researchers’ eventual intention involves permitting the cardiac muscle to take respite and curtailing its need for oxygen during the crucial convalescent period after a patient endures a heart-related crisis. The roles assigned to ACIS are commonly fulfilled by healthcare experts — however, the objective centers on the apparatus’s capacity to harmonize and refine the procedure, yielding improved results while alleviating burdens on the already stretched capabilities of medical professionals.

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Dr. Joe Alexander anticipates ACIS may one day “surpass the current standard treatments.”

NL: Could you elaborate on the kinds of details incorporated into the design?

JA: This Cardiovascular Bio Digital Twin captures pressures and movements throughout the circulatory apparatus, including the pressures and movements produced by each of the four sections of the cardiac muscle. … Our capability includes illustrating the cardiovascular apparatus kinetics in terms of pressures, movements, and volumes.

NL: And how do you convert this into practical steps for a distinct patient?

JA: Although it’s still early days, we do possess a blueprint for executing this. Fundamentally, we initially pursue the depiction of the “typical” cardiovascular apparatus for patients. Therefore, obtaining information pertaining to what’s “typical” holds tremendous value. [Editor’s note: The MEI Lab is collaborating with entities such as the National Cerebral and Cardiovascular Center located in Japan to gain entry to this category of details.]

However, it’s likely that pinpointing cohorts applicable to the specific patient stands as most critical — for example, individuals afflicted with cardiovascular conditions or those enduring cardiac insufficiency. In such instances, we actively seek data relating to that particular demographic; assuming we consider cardiac insufficiency. Leveraging this data, we can then approximate factors for our cardiovascular design that signify the overall patient population with cardiac insufficiency.

Within this cohort, as is common knowledge, significant variance exists. Are there supplementary attributes pertinent to our patient accessible for utilization? This could potentially include results derived from echocardiograms [EKG]; age; presence of comorbidities [other health concerns]; sex, whether male or female; and the surrounding environment. Should genetic details be procurable, we can locate a subcategory even more attuned to the patient.

Now, with ACIS, we [would] essentially link up a patient to our “initial estimation” of our Cardiovascular Bio Digital Twin which is anticipated to align with the patient based on population-level details. Because it functions as a feedback-driven regulating setup, the responses will instinctively readjust the parameters to allocate the necessary medications or device therapies that are crucial for satisfying a specific cardiac output demand in the patient. This methodology enables us to further tailor the Digital Twin to that particular patient.

NL: Can you clarify the operational approach of ACIS and its feedback mechanism?

JA: The core concept is akin to a “self-navigating” therapeutic, echoing the operation of a self-driving vehicle. However, in this perspective, “self-navigating” stands for the administration of suitable pharmaceuticals or, in instances of serious conditions, the allocation of medical-grade device therapies that a patient may require.

Our system enables us to define — literally input via the keyboard — the desired cardiac output, pulse, left atrial pressure, and arterial pressure that we aim for the patient to achieve. Subsequently, syringes equipped with the appropriate medications to instigate such modifications are powered by our design, or “best assessment” of what fits that particular patient. This entire procedure occurs after addressing the primary abnormality [such as a blood vessel obstruction] at the catheterization laboratory.

Imagine a situation where they presented with an occluded vessel; in such instances, it’s been unblocked or a stent is in place, and the patient is transitioned to the ICU [intensive care unit] or CCU [coronary care unit] for recuperation. Recuperation signifies that the cardiac muscle needs the chance to recover. This encompasses permitting the cardiac muscle to function with the least possible activity to sustain the required cardiac output.

We have an established method of administering drugs. Catecholamines serve to boost the contractility aptitude of the cardiac muscle. Nitrates diminish the cardiac muscle’s afterload, thereby minimizing the workload as it attempts ejection into the arterial circulation. Diuretics lower the volume of circulating blood and eradicate blood accumulation from the lungs, which might have resulted from the sudden episode of insufficiency.

These pharmaceuticals are generally provided by a physician; they will administer one medication, then observe the reaction, then proceed to another, continuously managing the patient over several days. Once our setup attains satisfactory operation — an achievement we are nearing, in my opinion — it becomes feasible to administer each of these pharmaceuticals concurrently, given our knowledge of the system’s responsiveness. This approach substantially reduces the duration of patient management.

The delivery of pharmaceuticals is facilitated by these autonomously managed syringes; subsequently, the patient undergoes a response, and this is fed back within the system. These values are then equated with those originally entered via the keyboard, and should any discrepancies arise, feedback procedures come into play to reduce that divergence. This additionally enriches the Digital Twin with vital data pertaining to the patient, thus enhancing future characterizations of the design’s resistance and capacitance attributes.

The Cardiovascular Digital Twin embodies the dynamics inherent to the circulatory apparatus through mathematical formulas and simulations.

NL: At what point in progress is ACIS at this moment?

JA: In animal testing using dogs, we effectively triggered acute cardiac insufficiency initially last year and were successful in enabling this independent system to correct arterial pressure as well as cardiac output in an independent method, all while curtailing myocardial [cardiac muscle] oxygen consumption.

Following that initial triumphant experiment approximately a year prior, we have observed several successive [animal] trials, all while elevating the sophistication of our feedback setup, thus augmenting its operational capacity leveraging sporadic details, mitigating the imperative for continuous sampling. It can be administered in sequences.

We foresee the need for several additional years dedicated to enhancing this setup, in animal trials — projected to be approximately three years further. Consequently, readiness for initial trials with human participants will ensue, wherein ACIS will be deployed in collaboration with a clinician [during initial tests on humans]. ACIS would then instruct the physician regarding the necessary dosages of these pharmaceuticals, and the physician will decide whether to carry out the directives, operating as a safety measure.

Up to this juncture, much of the discussion has revolved around pharmaceuticals; however, identical algorithms remain functional for medical devices, such as left ventricular assist devices [LVAD, one form of mechanical pump] or extracorporeal membrane oxygenation apparatuses [ECMO, which functions to circulate blood, letting both the cardiac muscle and lungs rest]. Every consideration fits within the ambit of our anticipations regarding achievement in experimental animals spanning the subsequent three years, before we move toward initial trials with humans.

NL: What procedural steps are in store for securing the approval of ACIS? What format might the trials pursue?

JA: It would closely emulate [the assessment of] an independent or self-navigating vehicle — encompassing levels ranging from 1 through 4 in autonomy.

In other words, enabling the setup to gradually shoulder increasing accountability and attentively observing its performance, leading to the ultimate acceptance of an independent setup wherein, in any event, a specialist would likely monitor its performance — comparable to someone seated in a self-driving vehicle, prepared to take control if complications materialize. I picture a similar sequence, mirroring that of a self-navigating vehicle.

NL: Long term, would ACIS persistently necessitate some degree of clinician oversight?

JA: Although I am steadfast in my advocacy for the concept of “independence,” I suspect that a cardiologist will nonetheless be present, monitoring perhaps multiple patients in unison.

I am profoundly dedicated to the notion that the apparatus we envision can, in reality, surpass the performance of a cardiologist. This notion may not be well-received by some cardiologists. Despite this, we intend to substantiate that premise, or convincingly imply its accuracy, by performing animal trials wherein the ACIS setup will be pitted against clinically proficient cardiologists. Our objective involves demonstrating diminished infarct scope [referring to the extent of cardiac muscle depletion] due to ACIS, contrasting the standard cardiologist-provided care.

NL: Assuming this device eventually garners approval, what specific area is anticipated to derive the most extensive advantage?

JA: Health Care encompasses the so-termed Quintuple Aim, highlighting the enhancement of patient satisfaction, the improvement of physician encounters, the elevation of population health standards, the reduction of care expenses, and the fostering of improved health equity. These individual points, as I perceive it, each have benefits from ACIS.

The patient would be afforded augmented concentration and care extended at a moment-by-moment measure — eliminating scenarios of a resident trying to juggle a range of patients simultaneously. A less specialized clinical caregiver could potentially be charged with supervising the conduct of the apparatus; an approach poised to improve the well-being of both the patient and the provider. The care provider won’t be under pressure to such a substantial extent.

Our anticipation involves this setup outperforming conventional practices, stemming from [our assertions] of more rapid convergence on curtailing myocardial oxygen utilization while stimulating augmented recuperation over the hospital stay. As a result, patients face fewer readmissions and complications following release. Cardiac events in these categories often entail some degree of cardiac injury, and some cardiac muscle tissue may have become infarcted. This augmented care level could curtail infarct dimensions, preserving more of the cardiac muscle throughout the treatment period.

NL: Upon transferring ACIS for the purpose of clinical assessments, what is slated as the ensuing undertaking?

JA: Considering our outlook, a natural transition anticipated over the upcoming 10 years, and more plausibly within the coming five, involves addressing chronic cardiac insufficiency. Chronic cardiac insufficiency necessitates handling greater intricacy, such as [tissue] restructuring, encompassing instances where the ventricles either thicken or widen, an event that alters their mechanics.

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