THT 2026: First-In-Human Smart Implant—Heart Failure Decongestion

Preliminary human experience with the smart device for heart failure decongestion will also be presented. Unlike traditional heart failure decongestion therapy which relies on pharmacological-based pressure reduction, this novel device seeks to remove fluid overload by controlling internal pressure. The device incorporates an internal pressure sensor as well as a programmable venous valve which dynamically redistributes fluid throughout the body and to the kidneys. Utilizing real-time data, patient and outpatient decongestion using the device is currently being performed by clinicians. Long-term experience with use of the device is expected to translate to improved consistency and efficacy of heart failure decongestion.

Why It Matters

Fluid overload leading to congestion is the major cause of worsening symptoms in heart failure patients, leading to the majority of worse symptom episodes and resulting in the majority of urgent visits and hospitalizations for patients with heart failure. Congestion causes fluid to seep into the lungs (pulmonary congestion), legs (peripheral oedema), and abdomen (ascites). Patients and their families face significant challenges when experiencing symptomatic congestion that requires treatment, with any delays to treatment resulting in a rapid clinical decline, particularly in the elderly and multi-morbid populations.

The standard approach to volume overload in heart failure involves the use of diuretics combined with maximal doses of medications recommended in heart failure guidelines. Currently, diuretics are the mainstay of volume management and are effective in the majority of patients at initiation of therapy. However, there are clear limitations to their use. For many patients, even standard doses of diuretics become ineffective in crucial situations such as illness, increased nutrition, or stress. Clinicians are then faced with very difficult decisions to ensure adequate patient symptom relief. Alternatively, even “usual” doses of diuretics may be poorly tolerated because of episodes of hypotension, potentially life threatening electrolyte abnormalities, worsening of kidney function, or episodes of dizziness and falls.

The device needs to be approached to the body in a mechanically controlled fashion and allow it to be tested as an alternate method of treatment for a mechanism of heart failure that current medication is unable to address: elevated venous pressure. High venous pressure causes fluid to leak out of the blood vessels and seep into tissues and organs all over the body, causing swelling. The kidneys are very particular about the pressure required for optimal function. They require a specific range of both arterial and venous pressures. A device that would increase the pressure in the veins draining the kidney would cause the kidneys to function poorly even with increased arterial flow. The patient could be on all the appropriate medications with associated swelling and decrease in urine output, until the venous back-pressure is relieved.

From the early reports, it appears this device safely lowers very high venous pressure inside the body to a level where oral diuretics are effective and it also measures those pressures. If such a device exists, it could potentially prevent the need for large doses of multiple intravenous diuretics to rapidly decompensating patients. It may also help to stabilize patients currently oscillating between periods of brief improvement followed by relapse, oscillating between admissions to hospital, losing function and quality of life.

From a health system perspective, it is possible that improved monitoring could allow on going decongestion in the community for heart failure patients. Many admissions for decompensated heart failure are for observation and fluid removal, rather than complex cardiology intervention, and as such could be the opportunity for health system transformation to monitoring in clinic or at home, and ambulatory service providing rapid access. This could aim to reduce readmissions, shorten the length of stay for those who are admitted, and improve patient experience by reducing avoidable attendance at emergency departments.

With the enhanced endolumenal approaches to bypass surgery gaining momentum and potentially becoming the new standard of care for the treatment of diabetes associated myocardial systolic dysfunction, the use of implants for circulatory support in the setting of advanced heart failure poses both safety and durability concerns. As with any medical or surgical implant, there is inherent risk to placement of the device, including bleeding and vascular injury, the potential for infection, and the risk of formation of device-related thrombi. The implant in question is designed to relieve symptoms of congestion, but like any technology designed to treat such problems, could potentially cause more harm than good, creating levels of undesirable venous obstruction, causing post procedural hypotension, or interacting in adverse fashion with other medical or surgical devices used to treat patients with advanced heart failure.

A forecast of the future performance of a “value story” for long-term management of heart failure will require an assessment of several outcomes important to patients and payers. These include reducing the need for hospitalization for decompensation of heart failure, improving functional status, improving symptoms, protecting kidney function, and mortality. Of note, quality of life measures and patient reported outcomes may be as important, if not more important, than pressure in the left ventricle. In addition to these measures, other factors will influence perceptions of value, including factors related to time spent in the clinic and complexity of troubleshooting, and the number and duration of need for additional medications (e.g. long-term anticoagulation).

Does this work in bigger populations? This technology is capable of facilitating physiology-guided decongestion in heart failure and could be a breakthrough technology in how we manage HF. Rather than waiting until late rescue in the ED for patients who are severely volume overloaded to intervene, this technology could enable step-wise increases in decongestion throughout the continuum of care to prevent severe volume overload. But even more exciting is the potential for monitoring with this technology to bring remote, data-driven decision-making to the care of patients with heart failure and allow cardio- and nephrologists to work more closely together to monitor a single important physiologic parameter and make shared decisions about diuretic dosing and volume-targeting in patients with both heart and kidney failure.

Who It Affects

The most relevant group would be those individuals with current illness who have chronic congestion on current medical therapy. These would include patients with recurrent or persistent symptoms of fluid overload despite optimal medical therapy; patients who require repeated hospitalisation for fluid overload; patients on increasing doses of diuretics; patients whose level of activity is limited by symptoms of fluid overload; and patients for whom optimal medical therapy is precluded by adverse effects on renal function, blood pressure or electrolytes.

Patients with heart failure also suffering from kidney disease are likely to be particularly disadvantaged by both conditions. Reducing fluid overload in such patients can place significant additional burden on a failing kidney, and sometimes cautious doses of diuretics are used to avoid adverse effects on renal function. However, as congestion worsens, further treatment of congestion with higher doses of established medications may be required, potentially putting the kidney at risk. A new approach which reduces venous back-pressure may therefore enable the kidneys to function better, allowing standard heart failure medications to be used at lower doses.

Not all patients with heart failure will be suitable for these medications, and appropriate patient selection will be crucial. Patients with reversible causes of their symptoms, such as dietary sodium excess, lack of medications, untreated hypertension, arrhythmias or sleep apnea, can be expected to stabilize with appropriate medical and lifestyle interventions. At the opposite end of the spectrum, patients with evidence of persistent venous hypertension, a history of symptom recurrences due to congestion, and who are on less than optimal doses of current heart failure medications, will likely have the most favorable benefit-to-risk ratio.

Other medical conditions can influence the decision to place an implant, and the management of medical and surgical conditions over time. Common co-existing conditions and their implications are shown in Table 1. Other factors that might be relevant include knowledge of the patient’s vascular anatomy, history of previous vascular surgery and other implanted devices. Some patients may be best managed medically, whereas for others, device therapy could be considered, provided the potential challenges and limitations are fully appreciated.

Management of the patient with hypertension and heart failure requiring decongestion will require an inter-disciplinary approach with input from many health care providers and an evolution of clinical roles. Decisions regarding device implantation could be performed in Interventional Cardiology, Vascular Surgery or centers experienced in venous procedures. Heart failure cardiologists will be crucial in selecting patients for these interventions and in titrating medical therapy. Nephrologists will be needed to weigh the potential risks of aggressive decongestion to the kidneys against potential benefits, and to manage medication in patients with electrolyte abnormalities, chronic kidney disease and fluctuating creatinine. Primary care providers will be essential for monitoring for infection, adhering to recommended dosing, and management of other comorbid conditions.

This device will succeed to the extent that nursing teams (and others monitoring the transmitter) are able to review data on a regular basis, set up appropriate escalation pathways, and educate patients on device use. In our managed care environment, heart failure nurse specialists manage medications and educate patients about their disease and medical management. The addition of this device is likely to further expand the role of these specialists to include data interpretation, regular solicitation of patient symptoms, and design and timely implementation of interventions in the clinic setting.

Health systems and payers will also have needs related to supportive infrastructure (e.g., staffing, training) and reimbursement policies. Hospitals will need a pathway for the implantation and follow-up of patients, including management of any device-related issues that may occur. Outpatient programs will require a platform for receiving and storing data, as well as an understanding of clinical responsibility. Payers will require evidence of benefit and cost-effectiveness, and will want to determine whether the device will reduce admissions enough to offset the cost of the procedure and the device itself.

Ensure address equity and access early in the technology’s implementation and be aware of the potential to disfavor patients by reducing health outcomes. While implementing and monitoring RF signals from ICDs to provide life-saving interventions to heart failure patients with ICDs who require CARDIOCRT RF can pose challenges to some patients (rural residents, those without transportation) , including reliable connectivity and digital comfort features such as smartphone app connectivity, can help level the playing field for patients with limited internet access. Innovative workflows involving phone assistance, community-based support, and caregiver involvement will be needed to ensure successful use of CARDIOCRT RF for heart failure patients.

What Changes

Early identification and management of ‘decongestion’ signals potentially worsening into a major public health problem, could be treated by a shift in management from in hospital decongestion to management of severe congestion in the home or clinic setting. Early recognition of congestion ‘signals’ will offer clinicians the opportunity to treat patients who are becoming congested before they suffer any severe symptoms, step by step, rather than a single, emergency, high technology, costly, and often intrusive hospital visit.

Needle swapping isn’t that easy, and phamanulation of antihypertensive gene expression likely requires more than just a simple change in technique. An entirely new workflow for patient management would be required from the time of implantation through followup, involving both a program and individuals who know how to select patients for the procedure, manage them around the time of the procedure, and monitor their effect. In addition, the provider needs to know the target levels of blood pressure, the evidence of renal congestion or other end-points of effect, how to intervene (and how to make that intervention reversible) as pressure signals increase and decrease, and how to document the changes between visits. The information provided has to be sufficient for other cardiologists, nephrologists, and primary care providers to provide continued care of patients receiving this therapy.

Remote monitoring of patients with diabetes has the potential to offer several benefits and raises several practical issues. Monitoring systems can allow for the delivery of timely care to patients; however, the monitoring of data from patients also results in the monitoring of alarms, trends and occasional edge cases. The staffing model of a clinic that is remotely monitoring patients will determine if the staff will be victims of alarm fatigue or able to catch a patient in clinically significant deterioration. Additionally, there are several thresholds that need to be determined such as a phone call versus a change in medication, same-week appointment versus an evaluation that day if possible.

Clinical safety is no longer just about ensuring the medical functionality of devices—it now includes consideration of cybersecurity and privacy as well as data governance. When devices connect to the cloud, not only must they have strong cybersecurity features to protect sensitive patient information but also adequate measures to ensure that data delivered to clinicians are accurate, complete and on time. Further, there are basic governance questions around devices connected to the cloud, such as who reviews data on a daily basis and how, how devices process data on weekends, how missed transmits will be detected and what is done to correct them, and obtaining and documenting patient consent for remote operations.

Use of venous devices, such as ventricular assist devices, is becoming more prevalent due to the high incidence of thrombosis. Patients with heart failure are often placed on anticoagulation and other methods to prevent thrombus formation; frequently they are on antiplatelet therapy or anticoagulation for other indications, including coronary artery disease or atrial fibrillation. The fear of serious bleeding effect on choice of antithrombotic therapy is increasing. Attendees of HF educational programs will expect a consensus-based approach for management of antithrombotic therapy for patients with heart failure, in addition to an understanding of the patient-specific risk of bleeding.

Treatment decisions will be made in collaboration with patients and their families. Although an implantable device may appeal to patients and their families because it is less invasive and results in fewer hospitalisations with better control of symptoms, this option is not without procedures, follow up and complications of its own. Therefore patients and their families require informed counselling regarding the implantable device option, the alternative treatment options available, the potential benefits and uncertainties of the treatment and a discussion of what management of the device will look like in the patients everyday life.

Reimbursement and widespread adoption of new technologies will depend upon evidence that matters to healthcare systems. Although initial evidence of technical success is crucial, ultimately performance data and pressure settings will only carry the device so far. It will be critical to present robust evidence demonstrating direct clinical outcomes such as reduction in hospitalizations for patients with hypertension, improvement in quality of life for end stage renal disease patients, preservation of kidney function and an acceptable toxicity profile. In addition, cost effective analyses will require quantification of staff time and costs associated with patients’ and clinicians’ time monitoring and receiving treatment with the device. The potential of the new therapy to reduce the need for costly inpatient hospitalizations will also be an important consideration.

Future studies on pulmonary capillary wedge pressure-supported breathing devices will evolve from feasibility studies to studies of durability, head-to-head comparisons with other devices, patient selection, comparison to optimal medical therapy and intensive outpatient diuretic program and real-world experience. Future registries will be important for detection of rare adverse events as well as for long-term device performance.

Looking inside the pressure building inside the heart could speed the day when heart failure patients receive more individualized health care. Many heart failure programs monitor their patients’ weight remotely or call them periodically and ask how they are feeling. By judging how well the heart is contracting, Mayo cardiothoracic surgeon Senthil Krishnankutty could allow doctors to more closely monitor their heart failure patients and intervene earlier to prevent a serious event. The information could also be valuable to other specialists, such as primary care physicians and pulmonologists, and potentially even enable patients to receive care in their living rooms, bringing more disciplines into the development of a more physiology-based approach to treating heart failure.

This is the world’s first smart, first-in-human device to treat venous congestion suitable for use in patients with fluid overload who are not responding to optimal standard of care. There will be considerable work to move this technology from a niche to a more mainstream device that can benefit patients around the world, through careful patient selection, appropriate monitoring and data collection, and adherence to long-term safety and efficacy follow-up.

References:

https://pubmed.ncbi.nlm.nih.gov/41841702/