European Heart Journal Supplements (2020) 22 (Supplement P), P29–P32 The Heart of the Matter doi:10.1093/eurheartj/suaa169 Advanced remote care for heart failure in times of COVID-19 using an implantable pulmonary artery pressure sensor: the new normal Antoni Bayes-Genis 1,2,3*, Pau Codina1, Omar Abdul-Jawad Altisent1, Evelyn Santiago1,3, Mar Domingo1,2,3, Germán Cediel1, Giosafat Spitaleri1, and Josep Lupón1,2,3 1 Heart Institute and Heart Failure Unit and Cardiology Department, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet s/n, 08916 Badalona, Spain; 2 Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain; and 3 CIBERCV, Instituto de Salud Carlos III, Madrid, Spain KEYWORDS Heart failure (HF) is a major public health problem and a leading cause of hospitali- Remote monitoring; zation in western countries. Over the past decades, the goal has been to find the Pulmonary artery pressure best method for monitoring congestive symptoms to prevent hospitalizations. sensor; Addressing this task through regular physician visits, blood tests, and imaging has COVID-19 proven insufficient for optimal control and has not decreased enough HF-related hos- pitalization rates. In recent years, new devices have been developed for this reason and CardioMEMS is one of the therapeutic monitoring options. CardioMEMS has shown to be effective in preventing and reducing HF hospitalizations in patients both with HF with reduced ejection fraction and HF with preserved ejection fraction. CardioMEMS’ versatility has made it a great option for pulmonary artery pressure monitoring, both during the coronavirus disease-19 (COVID-19) pandemic and when the clinic visits have (partially) resumed. CardioMEMS is the remote haemodynamic monitoring system with the most evidence-driven efficacy, and COVID-19 has put it in the spot as a centre-stage technology for HF monitoring. In a few months of the COVID-19 epidemic, CardioMEMS has grown to maturity, making it the new normal for high-quality, high-value remote HF care. Heart failure hospitalizations—a major six will have unrecognized HF (mainly HF with preserved public health problem ejection fraction, HFpEF).1 Since the earliest cases of coro- navirus disease-2019 (COVID-19) infection were reported, Heart failure (HF) is a major public health problem and a our care delivery systems have been challenged in unprece- leading cause of hospitalization in western countries. The dented ways, affecting all patients with cardiovascular pa- prevalence of HF is approximately 1–2% in the adult popula- thologies, but fundamentally those with HF.2 tion in developed countries, rising to 10% among people The aim of the management of HF is to maintain the >70 years of age. Among people >65 years of age present- pumping function of the heart and prevent progression to ing to primary care with breathlessness on exertion, one in decompensated HF, which is the most common cause of hospitalization in HF patients. Improvements in treatments and their implementation have improved survival and re- * Corresponding author. Tel: þ34 934978915, Fax: þ34 934978939, duced the hospitalization rate in patients with HF with re- Email: abayesgenis@gmail.com duced ejection fraction (HFrEF),1 although outcomes are Published on behalf of the European Society of Cardiology. VC The Author(s) 2020. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://crea- tivecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, pro- vided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com P30 A. Bayes-Genis et al. Figure 1 Active patients and percentage of patients meeting custom thresholds within EMEA included in Merlin.net data as of June 2020. still often unsatisfactory. The most recent European data to help monitor PAP and send the data on daily basis to pro- (ESC-HF pilot study) demonstrate that 12-month all-cause viders, allowing timely management of HF to help lower mortality rates for hospitalized and stable/ambulatory HF the hospitalization rate.17 patients were 17% and 7%, respectively, and the 12-month The CardioMEMS is a wireless pressure-sensitive device hospitalization rates were 44% and 32%, respectively.3 Over that uses microelectromechanical systems (MEMS) technol- the past decades, the goal has been to find the best ogy. It consists of an implantable HF sensor, a delivery cath- method for monitoring congestive symptoms to prevent eter, and an electronic monitoring unit. Using right heart hospitalizations. Addressing this task through regular physi- catheterization, the device is implanted in the distal left cian visits, blood tests, and imaging has proven insufficient posterior pulmonary artery. The device measures the pul- for optimal control and has not decreased enough HF- monary arterial pressure through ambient atmospheric related hospitalization rates. Hopes were set on circulating pressure changes detected by its barometer. CardioMEMS biomarkers, but even N-terminal pro-brain natriuretic pep- does not have any batteries or leads and is powered by an tide, which is an important new diagnostic and prognostic external antenna and radiofrequency signals. The elec- tool, cannot reliably predict mortality or overall hospitali- tronic unit transmits the PAP measurements daily. These zation rates.4 Numerous prognostic markers of death and/ data can be used by physicians to adjust the HF therapy or HF hospitalization have been identified in patients with (mainly through adjusting the diuretic dose) before conges- HF. More recently, several multivariable prognostic risk tive symptoms develop, ultimately resulting in lower hospi- scores have been developed for different populations of talization rates.18 patients with HF,5–7 and some are available as interactive The goal of the CHAMPION trial (CardioMEMS Heart online applications. Multivariable risk scores have been de- Sensor Allows Monitoring of Pressures to Improve Outcomes veloped to help predict death in patients with HF, but in in New York Heart Association (NYHA) Functional Class III general, they remain less useful for the prediction of subse- Heart Failure Patients) was to determine if physicians could quent HF hospitalizations.6,7 reduce HF hospitalizations by managing patient PAP using Long before the COVID-19 pandemic altered our lives, the CardioMEMS HF System.18 The trial, published almost a remote monitoring emerged as a viable way to overcome decade ago, met its primary efficacy endpoint of reduction the long interval between office visits, monitor patients re- in the rate of HF hospitalizations, with the treatment arm motely, and keep them safe by identifying disease progres- having 28% fewer HF hospitalizations compared with the sion in time to prevent hospitalization. Non-invasive control arm at 6 months. Men and women in the treatment methods of monitoring HF patients, such as consistent group had similar HF hospitalization rates. The CHAMPION scheduled phone calls with patients and transfer of physio- trial also met its secondary efficacy endpoints, with the logic data through electronic devices, have been studied treatment arm having lower PAP, fewer days in the hospi- but have not had significant impact on mortality or hospi- tal, and better quality of life compared with the control talization rates.8–12 Numerous clinical trials have been con- arm. Over the entire randomized follow-up in the 1.5-year ducted to assess the impact of implantable cardiac trial, treatment-group patients had 33% fewer HF hospital- electronic devices in the management of HF and early de- izations than control group patients. For every 100 patients tection of congestive symptoms (e.g. intrathoracic imped- treated, 23 HF hospitalizations were prevented per year. ance), but the results are equivocal and not precise enough The current recommendation for CardioMEMS use is in to allow early detection of fluid retention and timely man- NYHA Class III HF patients who have been hospitalized for agement.13–15 In sum, non-haemodynamic-based remote HF within 1 year prior to implantation. An important vari- monitoring has not proven to reduce HF hospitalization. able in the assessment of CardioMEMS’ effectiveness in re- ducing hospitalization is the 30-day rate of readmission. Haemodynamic monitoring using Adamson et al.19 showed that medications were changed CardioMEMS more often in the treatment group compared with the con- trol group and that the overall rate of hospitalization was Continuous monitoring of pulmonary artery pressure (PAP) 49% lower in the treatment than in the control group. It could be used as an indicator of HF and would allow optimal was also determined that all-cause 30-day readmissions monitoring and timely management before the occurrence were 58% lower in the treatment group. Subset analysis of of symptomatic, acutely decompensated HF.16 The the CHAMPION trial has shown that the sensor can also lead CardioMEMS device was created for this purpose and ap- to better haemodynamic management of patients proved by the Food and Drug Administration (FDA) in 2014 with preserved ejection fraction and lower rates of Advanced remote care for HF in times of COVID-19 P31 pandemic to provide better assessment of HF clinical sta- tus, while maintaining social distancing through the perfor- mance of virtual visits. As pointed out by Abraham et al.,25 these systems accompanied by their dedicated cloud- based information management are no longer the future but the present of improved HF care. The authors suggest, as a first step for implementation, that high-risk patients at home and in settings like nursing homes might be the first recipients of such technology-driven remote HF assessment. Figure 2 Number of patients that required hospitalization out of all ac- It is highly likely that these indications will expand tive patients within EMEA included in Merlin.net data as of June 2020. quickly to lower-risk patients as both patients and physi- Remarkably, despite the peak of the COVID-19 pandemic in Europe during the months of March, April, and May, a clear decrease in hospitalizations cians become more familiar with the added value of hae- was observed. modynamic remote monitoring. Indeed, a remarkable increase in the number of CardioMEMS active patients has been observed in Europe, the Middle East, and Africa hospitalization when compared with standard therapy.20 A (EMEA) during the first semester of 2020, up from 706 ac- recently published post-approval study of 1200 patients in tive patients in January to 766 in June (Figure 1). multiple practice settings demonstrated a 58% reduction in Furthermore, during the high peak of the first wave of HF hospitalizations and a 28% reduction in all-cause hospi- SARS-CoV-2 infections, a substantial decrease in hospital- talizations during the year after implantation of izations was identified among HF patients with implanted CardioMEMS.21 CardioMEMS devices. Additional confounders during the An economic analysis of data from the CHAMPION trial pandemic must be taken in consideration, including pa- showed an incremental cost-effectiveness ratio based on tient fear and legally imposed restricted mobilisation, and all-cause comprehensive management of HF patients of it would be incorrect to attribute this entirely to $29,593 per quality-adjusted life-year gained when the CardioMEMS. Figure 2 illustrates the number of patients patients were managed with PAP monitoring;22 these anal- that required hospitalizations out of all active patients yses indicate that the CardioMEMS HF System is a cost- within EMEA included in Merlin.net data as of June 2020. Of effective solution. note, CardioMEMS, as other telemedicine systems, can Singh et al.23 showed, before the COVID-19 pandemic in- help to manage HF patients outside of the hospital setting vaded us, that despite its well-established beneficial clini- during a pandemic but this should not be the exclusive rec- cal outcomes in the management of HF patients, adoption ommendation, as discussed above. of CardioMEMS was slow and among their patient popula- tion only 21% of patients eligible for the device received it. Conclusions CardioMEMS and COVID-19 To conclude, due to both the ever-increasing costs associ- ated with health care admissions and the social distancing The COVID-19 pandemic has significantly impacted imposed by COVID-19, finding solutions for better monitor- patients with HF and their care delivery systems. To reduce ing of HF has become imperative. In recent years a series of severe acute respiratory syndrome coronavirus-2 (SARS- new devices has been created for this reason and CoV-2) transmission, health systems have largely transi- CardioMEMS is one of the therapeutic monitoring options. tioned to noncontact care delivery methods for ambulatory CardioMEMS has been shown to be effective in preventing care. DeFilippis et al.24 indicate that such services may in- and reducing HF hospitalizations in patients with HFrEF and clude telehealth visits, during which an audiovisual tele- HFpEF. CardioMEMS’ versatility has made it a great option communication system is used; virtual check-ins between for PAP monitoring, both during the pandemic and when the patient and provider via telephone or another device, clinic visits resume. CardioMEMS is the remote haemody- which are conducted to decide whether additional services namic monitoring system with the most evidence-driven are needed; and electronic visits (‘e-visits’), which are efficacy, and COVID-19 has put it in the spot as a centre- communications between patients and providers through stage technology for HF monitoring. In a few months of the an online portal. Of note, despite the well-established fea- COVID-19 epidemic, CardioMEMS has grown to maturity sibility and safety of these telemedicine systems for more than it had in the past decade, making it the new nor- patients with HF, their use has not yet been reliably associ- mal for high-quality, high-value remote HF care. ated with a reduction in emergency department visits or hospitalizations.8–12 Importantly, the option for in-person Funding clinic visits should remain available for patients without ac- cess to telemedicine services, high-risk patients (e.g. This paper was published as part of a supplement sup- patients on continuous inotropes), and those for whom ported by an educational grant from Abbott. physical examination is critical for clinical decision- making. 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