Future of smart cardiovascular implants

Cardiovascular disease remains the leading cause of death in Western society. Recent technological advances have opened the opportunity of developing new and innovative smart stent devices that have advanced electrical properties that can improve diagnosis and even treatment of previously intractable conditions, such as central line access failure, atherosclerosis and reporting on vascular grafts for renal dialysis. Here we review the latest advances in the field of cardiovascular medical implants, providing a broad overview of the application of their use in the context of cardiovascular disease rather than an in-depth analysis of the current state of the art. We cover their powering, communication and the challenges faced in their fabrication. We focus specifically on those devices required to maintain vascular access such as ones used to treat arterial disease, a major source of heart attacks and strokes. We look forward to advances in these technologies in the future and their implementation to improve the human condition

EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring

Aim: Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated. Methods and results: Atotal of 312 patients with VVI-or DDD-ICD implants from 17 centres in six EU countries were randomised to HMON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar-or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 +/- 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 +/- 1.67 vs. 5.53 +/- 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 +/- 1.50 vs. 0.62 +/- 1.25; P < 0.005), more non-office-based contacts (1.95+3.29 vs. 1.01 +/- 2.64; P < 0.001), more Internet sessions (11.02 +/- 15.28 vs. 0.06 +/- 0.31; P < 0.001) and more in-clinic discussions (1.84 +/- 4.20 vs. 1.28 +/- 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 +/- 1.18 vs. 0.85 +/- 1.43, P = 0.23) and shorter length-of-stay (6.31 +/- 15.5 vs. 8.26 +/- 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): (sic)204 169-238) vs. (sic)213 (182-243); range for difference ((sic)-36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of (sic)408 (327-489) vs. (sic)400 (345-455); range for difference ((sic)-104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different. Conclusion: For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation

Association of Ambulatory Hemodynamic Monitoring With Clinical Outcomes in a Concurrent Matched Control Analysis.

Importance: In a randomized clinical trial, heart failure (HF) hospitalizations were lower in patients managed with guidance from an implantable pulmonary artery pressure sensor compared with usual care. It remains unclear if ambulatory monitoring could also improve long-term clinical outcomes in real-world practice. Objective: To determine the association between ambulatory hemodynamic monitoring and rates of HF hospitalization at 12 months in clinical practice. Design, Setting, and Participants: This case-control study of Medicare beneficiaries used claims data collected between June 1, 2014, and March 31, 2016. Medicare patients who received implants of a pulmonary artery pressure sensor were identified from the 100% Medicare claims database. Each patient who received an implant was matched to a control patient by demographic features, history of HF hospitalization, and number of all-cause hospitalizations. Propensity scoring based on comorbidities (arrhythmia, hypertension, diabetes, pulmonary disease, and renal disease) was used for additional matching. Data analysis was completed from July 2017 through January 2019. Exposures: Implantable pulmonary artery pressure monitoring system. Main Outcomes and Measures: The rates of HF hospitalization were compared using the Andersen-Gill method. Days lost owing to events were compared using a nonparametric bootstrap method. Results: The study cohort consisted of 1087 patients who received an implantable pulmonary artery pressure sensors and 1087 matched control patients. The treatment and control cohorts were well matched by age (mean [SD], 72.7 [10.2] years vs 72.9 [10.1] years) and sex (381 of 1087 female patients [35.1%] in each group), medical history, comorbidities, and timing of preimplant HF hospitalization. At 12 months postimplant, 616 HF hospitalizations occurred in the treatment cohort compared with 784 HF hospitalizations in the control cohort. The rate of HF hospitalization was lower in the treatment cohort at 12 months postimplant (hazard ratio [HR], 0.76 [95% CI, 0.65-0.89]; P \u3c .001). The percentage of days lost to HF hospitalizations or death were lower in the treatment group (HR, 0.73 [95% CI, 0.64-0.84]; P \u3c .001) and the percentage of days lost owing to all-cause hospitalization or death were also lower (HR, 0.77 [95% CI, 0.68-0.88]; P \u3c .001). Conclusions and Relevance: Patients with HF who were implanted with a pulmonary artery pressure sensor had lower rates of HF hospitalization than matched controls and spent more time alive out of hospital. Ambulatory hemodynamic monitoring may improve outcomes in patients with chronic HF

Cyborg heart: The affective apparatus of bodily production of ICD patients

We argue that a cyborg approach both emphasizes the complexity in treating patients with implantable cardioverter defibrillators (ICDs) attached to home monitoring devices, and makes it possible to decipher modern perspectives in the notion of ‘Patient 2.0’ and other representations of patients. We attempt to open up the notion of Patient 2.0 exemplified by ICD patients by drawing on the cyborg idea as developed by Donna Haraway as well as her understanding of science and the body as an apparatus of bodily production. We include the feminists Rosi Braidotti, Anne Balsamo, Geoff Bowker, and Leigh Star in discussing the cyborg, its infrastructures and affective potentials. We analyse modern imaginaries of remote monitoring as they are portrayed on the websites of the two largest manufacturers of ICD technologies, and based on an analysis of the apparatus of bodily production involved when patients visit a hospital to have their illness monitored we propose the analytical device cyborg heart to capture an affective apparatus of bodily production in the clinic and the idea of an enlarged sense of community as opposed to modern imaginaries of patient empowerment. Finally we discuss how the device cyborg heart differs from the notion logic of care

Cost-effectiveness of remote haemodynamic monitoring by an implantable pulmonary artery pressure monitoring sensor (CardioMEMS-HF system) in chronic heart failure in the Netherlands

Aims: Remote haemodynamic monitoring with an implantable pulmonary artery (PA) sensor has been shown to reduce heart failure (HF) hospitalizations and improve quality of life. Cost-effectiveness analyses studying the value of remote haemodynamic monitoring in a European healthcare system with a contemporary standard care group are lacking. Methods and results: A Markov model was developed to estimate the cost-effectiveness of PA-guided therapy compared to the standard of care based upon patient-level data of the MONITOR-HF trial performed in the Netherlands in patients with chronic HF (New York Heart Association class III and at least one previous HF hospitalization). Cost-effectiveness was measured as the incremental cost per quality-adjusted life year (QALY) gained from the Dutch societal perspective with a lifetime horizon which encompasses a wide variety of costs including costs of hospitalizations, monitoring time, telephone contacts, laboratory assessments, and drug changes in both treatment groups. In the base-case analysis, PA-guided therapy increased costs compared to standard of care by €12 121. The QALYs per patient for PA-guided therapy and standard of care was 4.07 and 3.481, respectively, reflecting a gain of 0.58 QALYs. The resulting incremental cost-effectiveness ratio was €20 753 per QALY, which is below the Dutch willingness-to-pay threshold of €50 000 per QALY gained for HF. Conclusions: The current cost-effectiveness study suggests that remote haemodynamic monitoring with PA-guided therapy on top of standard care is likely to be cost-effective for patients with symptomatic moderate-to-severe HF in the Netherlands.</p

Cost-effectiveness of remote haemodynamic monitoring by an implantable pulmonary artery pressure monitoring sensor (CardioMEMS-HF system) in chronic heart failure in the Netherlands

Aims: Remote haemodynamic monitoring with an implantable pulmonary artery (PA) sensor has been shown to reduce heart failure (HF) hospitalizations and improve quality of life. Cost-effectiveness analyses studying the value of remote haemodynamic monitoring in a European healthcare system with a contemporary standard care group are lacking. Methods and results: A Markov model was developed to estimate the cost-effectiveness of PA-guided therapy compared to the standard of care based upon patient-level data of the MONITOR-HF trial performed in the Netherlands in patients with chronic HF (New York Heart Association class III and at least one previous HF hospitalization). Cost-effectiveness was measured as the incremental cost per quality-adjusted life year (QALY) gained from the Dutch societal perspective with a lifetime horizon which encompasses a wide variety of costs including costs of hospitalizations, monitoring time, telephone contacts, laboratory assessments, and drug changes in both treatment groups. In the base-case analysis, PA-guided therapy increased costs compared to standard of care by €12 121. The QALYs per patient for PA-guided therapy and standard of care was 4.07 and 3.481, respectively, reflecting a gain of 0.58 QALYs. The resulting incremental cost-effectiveness ratio was €20 753 per QALY, which is below the Dutch willingness-to-pay threshold of €50 000 per QALY gained for HF. Conclusions: The current cost-effectiveness study suggests that remote haemodynamic monitoring with PA-guided therapy on top of standard care is likely to be cost-effective for patients with symptomatic moderate-to-severe HF in the Netherlands.</p

A Three – tier bio-implantable sensor monitoring and communications platform

One major hindrance to the advent of novel bio-implantable sensor technologies is the need for a reliable power source and data communications platform capable of continuously, remotely, and wirelessly monitoring deeply implantable biomedical devices. This research proposes the feasibility and potential of combining well established, ‘human-friendly' inductive and ultrasonic technologies to produce a proof-of-concept, generic, multi-tier power transfer and data communication platform suitable for low-power, periodically-activated implantable analogue bio-sensors. In the inductive sub-system presented, 5 W of power is transferred across a 10 mm gap between a single pair of 39 mm (primary) and 33 mm (secondary) circular printed spiral coils (PSCs). These are printed using an 8000 dpi resolution photoplotter and fabricated on PCB by wet-etching, to the maximum permissible density. Our ultrasonic sub-system, consisting of a single pair of Pz21 (transmitter) and Pz26 (receiver) piezoelectric PZT ceramic discs driven by low-frequency, radial/planar excitation (-31 mode), without acoustic matching layers, is also reported here for the first time. The discs are characterised by propagation tank test and directly driven by the inductively coupled power to deliver 29 μW to a receiver (implant) employing a low voltage start-up IC positioned 70 mm deep within a homogeneous liquid phantom. No batteries are used. The deep implant is thus intermittently powered every 800 ms to charge a capacitor which enables its microcontroller, operating with a 500 kHz clock, to transmit a single nibble (4 bits) of digitized sensed data over a period of ~18 ms from deep within the phantom, to the outside world. A power transfer efficiency of 83% using our prototype CMOS logic-gate IC driver is reported for the inductively coupled part of the system. Overall prototype system power consumption is 2.3 W with a total power transfer efficiency of 1% achieved across the tiers

O Efeito da Monitorização Remota em Eventos Cardíacos Adversos numa Amostra Emparelhada por Propensity-Score Matching

AIMS: There are conflicting data regarding the clinical benefits of device-based remote monitoring (RM). We sought to assess the effect of device-based RM on long-term clinical outcomes in recipients of implantable cardioverter-defibrillators (ICDs). METHODS: We assessed the incidence of adverse cardiac events, overall mortality and device therapy efficacy and safety in a propensity score-matched cohort of patients under RM compared to patients under conventional follow-up. Data on hospitalizations, mortality and cause of death were systematically assessed using a nationwide healthcare platform. The primary outcome was time to a composite outcome of first hospital admission for heart failure or cardiovascular death. RESULTS: Of a total of 923 implantable device recipients, 164 matched patients were identified (84 under RM, 84 under conventional follow-up). The mean follow-up was 44 months (range 1-123). There were no significant differences regarding baseline characteristics in the matched cohorts. Patients under RM had a significantly lower incidence of the primary outcome (hazard ratio [HR] 0.42, confidence interval [CI] 0.20-0.88, p=0.022); there was a non-significant trend towards lower overall mortality (HR 0.53, CI 0.27-1.04, p=0.066). No significant differences between cohorts were found regarding appropriate therapies (RM vs. conventional follow-up, 8.1 vs. 8.2%, p=NS) or inappropriate therapies (6.8 vs. 5.0%, p=NS). CONCLUSION: In a propensity score-matched cohort of ICD recipients with long-term follow-up, RM was associated with a lower rate of a combined endpoint of hospital admission for heart failure or cardiovascular death.info:eu-repo/semantics/publishedVersio

Remote monitoring for better management of LVAD patients: the potential benefits of CardioMEMS

Left ventricular assist devices (LVAD) are frequently used in the treatment of end-stage heart failure (HF), and due to the shortage of heart donors and destination programs, it is likely to keep on growing. Still, LVAD therapy is not without complications and morbidity and rehospitalization rates are high. New ways to improve LVAD care both from the side of the patient and the physician are warranted. Remote monitoring could be a tool to tailor treatment in these patients, as no feedback exists at all about patient functioning on top of the static pump parameters. We aim to provide an overview and evaluation of the novel remote monitoring strategies to optimize LVAD management and elaborate on the opportunities of remote hemodynamic monitoring with CardioMEMS, at home in these patients as the next step to improve care