Subcutaneous sensors for monitoring congestion and to reduce heart failure hospitalizations—a viable middle ground between deep implantable intravascular monitoring devices and wearable technologies?

Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS (2023) Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res 118(17):3272–3287. https://doi.org/10.1093/cvr/cvac013

Metra M, Adamo M, Tomasoni D, Mebazaa A, Bayes-Genis A, Abdelhamid M, Adamopoulos S, Anker SD, Bauersachs J, Belenkov Y, Böhm M, Gal TB, Butler J, Cohen-Solal A, Filippatos G, Gustafsson F, Hill L, Jaarsma T, Jankowska EA, Lainscak M, Lopatin Y, Lund LH, McDonagh T, Milicic D, Moura B, Mullens W, Piepoli M, Polovina M, Ponikowski P, Rakisheva A, Ristic A, Savarese G, Seferovic P, Sharma R, Thum T, Tocchetti CG, Van Linthout S, Vitale C, Von Haehling S, Volterrani M, Coats AJS, Chioncel O, Rosano G (Jul2023) Pre-discharge and early post-discharge management of patients hospitalized for acute heart failure: a scientific statement by the Heart Failure Association of the ESC. Eur J Heart Fail 25(7):1115–1131

Article  PubMed  Google Scholar 

Mullens W, Damman K, Harjola VP, Mebazaa A, Brunner-La Rocca HP, Martens P, Testani JM, Tang WHW, Orso F, Rossignol P, Metra M, Filippatos G, Seferovic PM, Ruschitzka F, Coats AJ (2019) The use of diuretics in heart failure with congestion - a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail 21(2):137–155

Lucà F, Cipolletta L, Di Fusco SA, Iorio A, Pozzi A, Rao CM, Ingianni N, Benvenuto M, Madeo A, Fiscella D, Benedetto D, Francese GM, Gelsomino S, Zecchin M, Gabrielli D, Gulizia MM (Sep2019) Remote monitoring: doomed to let down or an attractive promise? Int J Cardiol Heart Vasc 24:100380

PubMed  PubMed Central  Google Scholar 

Pellicori P, Kaur K, Clark AL (Oct2015) Fluid management in patients with chronic heart failure. Card Fail Rev 1(2):90–95

Article  PubMed  PubMed Central  Google Scholar 

Patil RK, Goyal P, Swaminathan RV, Kim LK, Feldman DN (Jun2017) Invasive hemodynamic assessment of patients with heart failure and pulmonary hypertension. Curr Treat Options Cardiovasc Med 19(6):40

Article  PubMed  Google Scholar 

Lindenfeld J, Costanzo MR, Zile MR, Ducharme A, Troughton R, Maisel A, Mehra MR, Paul S, Sears SF, Smart F, Johnson N, Henderson J, Adamson PB, Desai AS, Abraham WT (2024) Implantable hemodynamic monitors improve survival in patients with heart failure and reduced ejection fraction. J Am Coll Cardiol 83(6):682–694

Article  CAS  PubMed  Google Scholar 

Sergi I, Montanaro T, Shumba AT, Bramanti A, Ciccarelli M, Carrizzo A, Visconti P, Vittorio MD, Patrono L (2023) An IoT-aware system for remote monitoring of patients with chronic heart failure. pp 1–5. https://doi.org/10.23919/SpliTech58164.2023.10193338

Gardner RS, Singh JP, Stancak B, Nair DG, Cao M, Schulze C, Thakur PH, An Q, Wehrenberg S, Hammill EF, Zhang Y, Boehmer JP (2018) HeartLogic multisensor algorithm identifies patients during periods of significantly increased risk of heart failure events. Circ: Heart Fail 11(7):e004669

Tang WHW, Warman EN, Johnson JW, Small RS, Heywood JT (2012) Threshold crossing of device-based intrathoracic impedance trends identifies relatively increased mortality risk. Eur Heart J 33(17):2189–2196

Article  PubMed  PubMed Central  Google Scholar 

Calò L, Bianchi V, Ferraioli D, Santini L, Dello Russo A, Carriere C, Santobuono VE, Andreoli C, La Greca C, Arena G, Talarico A, Pisanò E, Santoro A, Giammaria M, Ziacchi M, Viscusi M, De Ruvo E, Campari M, Valsecchi S, D’Onofrio A (Oct2021) Multiparametric implantable cardioverter-defibrillator algorithm for heart failure risk stratification and management: an analysis in clinical practice. Circ Heart Fail 14(10):e008134

Article  PubMed  PubMed Central  Google Scholar 

Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS (2011) Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 377(9766):658–66

Amir O, Ben-Gal T, Weinstein JM, Schliamser J, Burkhoff D, Abbo A, Abraham WT (2017) Evaluation of remote dielectric sensing (ReDS) technology-guided therapy for decreasing heart failure re-hospitalizations. Int J Cardiol 240:279–284

Uriel N, Sayer G, Imamura T, Rodgers D, Kim G, Raikhelkar J, Sarswat N, Kalantari S, Chung B, Nguyen A, Burkhoff D, Abbo A (2018) Relationship between noninvasive assessment of lung fluid volume and invasively measured cardiac hemodynamics. J Am Heart Assoc 7(22):e009175

Hughes A, Shandhi MMH, Master H, Dunn J, Brittain E (2023) Wearable devices in cardiovascular medicine. Circ Res 132(5):652–670

Piorkowski C, Busch M, Nölker G, Schmitt J, Roithinger FX, Young G, Táborský M, Herrmann G, Schmitz D (2019) Clinical evaluation of a small implantable cardiac monitor with a long sensing vector. Pacing Clin Electrophysiol 42(7):1038–1046

Article  PubMed  PubMed Central  Google Scholar 

Nölker G, Mayer J, Boldt LH, Seidl K, VAN Driel V, Massa T, Kollum M, Brachmann J, Deneke T, Hindricks G, Jung W, Brunner KJ, Kraus S, Hümmer A, Lewalter T (2016) Performance of an Implantable cardiac monitor to detect atrial fibrillation: results of the DETECT AF study. J Cardiovasc Electrophysiol 27(12):1403–1410

Sanders P, Pürerfellner H, Pokushalov E, Sarkar S, Di Bacco M, Maus B, Dekker LRC (2016) Performance of a new atrial fibrillation detection algorithm in a miniaturized insertable cardiac monitor: results from the Reveal LINQ Usability Study. Heart Rhythm 13(7):1425–1430

Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck K-H, Lebedev D, Rieger G, Pürerfellner H (2010) Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation results of the XPECT trial. Circ: Arrhythmia and Electrophysiol 3(2):141–147

Stolen C, Rosman J, Manyam H, Kwan B, Kelly J, Perschbacher D, Garner J, Richards M (Jan2023) Preliminary results from the LUX-Dx insertable cardiac monitor remote programming and performance (LUX-Dx PERFORM) study. Clin Cardiol 46(1):100–107

Article  PubMed  Google Scholar 

Steinhaus DM, Lemery R, Bresnahan Jr DR, Handlin L, Bennett T, Moore A, Cardinal D, Foley L, Levine R (1996) Initial experience with an implantable hemodynamic monitor. Circ 93(4):745–52

Zile MR, Bennett TD, St. John Sutton M, Cho YK, Adamson PB, Aaron MF, Aranda JM, Abraham WT, Smart FW, Stevenson LW, Kueffer FJ, Bourge RC (2008) Transition from chronic compensated to acute decompensated heart failure. Circ 118(14):1433–1441

Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP (2017) A multisensor algorithm predicts heart failure events in patients with implanted devices: results from the MultiSENSE study. JACC: Heart Failure 5(3):216–225

Vaduganathan M, DeFilippis EM, Fonarow GC, Butler J, Mehra MR (2017) Postmarketing adverse events related to the CardioMEMS HF system. JAMA cardiology 2(11):1277–1279

Article  PubMed  PubMed Central  Google Scholar 

Lindenfeld J, Zile MR, Desai AS, Bhatt K, Ducharme A, Horstmanshof D, Krim SR, Maisel A, Mehra MR, Paul S, Sears SF, Sauer AJ, Smart F, Zughaib M, Castaneda P, Kelly J, Johnson N, Sood P, Ginn G, Henderson J, Adamson PB, Costanzo MR (2021) Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet 398(10304):991–1001

Sharif F, Rosenkranz S, Bartunek J, Kempf T, Assmus B, Mahon NG, Hiivala NJ, Mullens W (2024) Twelve-month follow-up results from the SIRONA 2 clinical trial. ESC Heart Fail

Wetterling F, Sheridan WS, Testani JM, Borlaug BA, Fudim M, Damman K, Gray A, Gaines P, Poloczek M, Madden S, Tucker J, Buxo T, Gaul R, Corcoran L, Sweeney F, Burkhoff D (May2023) Safety and performance of a novel implantable sensor in the inferior vena cava under acute and chronic intravascular volume modulation. Eur J Heart Fail 25(5):754–763

Article  PubMed  Google Scholar 

Perl L, Meerkin D, D’Amario D, Avraham BB, Gal TB, Weitsman T, Hasin T, Ince H, Feickert S, D’Ancona G, Schaefer U, Sievert H, Leyva F, Whinnett ZI, Di Mario C, Jonas M, Glikson M, Habib M, Caspi O, Koren O, Abraham WT, Kornowski R, Crea F, Investigators V-HT (Jun2022) The V-LAP system for remote left atrial pressure monitoring of patients with heart failure: remote left atrial pressure monitoring. J Card Fail 28(6):963–972

Article  PubMed  Google Scholar 

Wetterling F, Kittipibul V, Fudim M (2024)  Measurement inaccuracy reported via the Manufacturer and User Facility Device Experience database for an implantable pulmonary artery pressure sensor: recalibration direction and magnitude results. Eur Heart J 45(Supplement_1):ehae666.3536. https://academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.3536/7838236?login=true

Fudim M, Hernandez AF, Felker GM (2017) Role of volume redistribution in the congestion of heart failure. J Am Heart Assoc 6(8):e006817

Article  PubMed  PubMed Central  Google Scholar 

Kalra PR, Gogorishvili I, Khabeishvili G, Málek F, Toman O, Critoph C, Flett AS, Cowburn PJ, Mehra MR, Sheridan WS (2025) First-in-human implantable inferior vena cava sensor for remote care in heart failure: FUTURE-HF. JACC: Heart Failure

Cui X, Thunström E, Dahlström U, Zhou J, Ge J, Fu M (2020) Trends in cause-specific readmissions in heart failure with preserved vs. reduced and mid-range ejection fraction. ESC Heart Failure 7(5):2894–2903

Article  PubMed  PubMed Central  Google Scholar 

Daniels A, Bhatt K (2025) Novel FIRE1 Inferior Vena Cava Sensor Effective In Tracking And Managing Fluid Shifts In A Heart Failure Patient. J Cardiac Fail 31(1):279

Article  Google Scholar 

Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB (2010) Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography: endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr 23(7):685–713

Article  PubMed  Google Scholar 

Zile MR, Kahwash R, Sarkar S, Koehler J, Zielinski T, Mehra MR, Fonarow GC, Gulati S, Butler J (2024) A novel heart failure diagnostic risk score using a minimally invasive subcutaneous insertable cardiac monitor. JACC: Heart Failure 12(1):182–196

Bang J (2023) Subcutaneously Insertable cardiac monitor for atrial fibrillation and HF using ECG and phonocardiography as biomarkers. JACC: Basic to Translational Science 8(4):380–382

Fareh S, Nardi S, Argenziano L, Diamante A, Scala F, Mandurino C, Magnocavallo M, Poggio L, Scarano M, Gianfrancesco D, Palma F, Silvetti MS, Porcelli D, Racheli M, Montoy M, Charles P, Campari M, Valsecchi S, Lavalle C (Dec2024) Implantation of a novel insertable cardiac monitor: preliminary multicenter experience in Europe. J Interv Card Electrophysiol 67(9):2117–2125

Article  CAS  PubMed  PubMed Central  Google Scholar 

Rothman AM, Zafar H, Sandy R, Wright C, Mitra S, Ebah L, Ilyas D, Hanumapura P, Sebastien S, Khalifa A (2023) A subcutaneous multiparameter sensor with integrated interstitial fluid pressure measurement for remote heart failure monitoring. Basic to Translational Science 8(4):386–388

Article  PubMed  PubMed Central  Google Scholar 

Kahwash R, Zile MR, Chalasani P, Bertolet B, Gravelin L, Khan MS, Wehking J, Van Dorn B, Sarkar S, Laager V, Gerritse B, Laechelt A, Butler J, ALLEVIATE‐HF Phase I Investigators (2024)  “Personalized Intervention strategy based on a risk score generated from subcutaneous insertable cardiac monitor: results from phase 1 of ALLEVIATE-HF. J Am Heart Assoc 13(20):e035501

Alvarez-Garcia J, Lala A, Rivas-Lasarte M, De Rueda C, Brunjes D, Lozano-Jimenez S, Garcia-Sebastian C, Mitter S, Remior P, Jimenez-Blanco Bravo M (2024) Remote dielectric sensing before and after discharge in patients with ADHF: the ReDS-SAFE HF trial. Heart Failure 12(4):695–706

Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M (2014) Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. The Lancet 384(9943):583–590

Article  Google Scholar 

Mariani MV, Lavalle C, Forleo GB, Della Rocca DG, Martino A, Panuccio M, Fagagnini A, Rebecchi M, Calò L, Santini L (2023) HeartLogic™: real-world data—efficiency, resource consumption, and workflow optimization. Eur Heart J Supple 25(Supplement_C):C331-C336

Kobe EA, McVeigh T, Hameed I, Fudim M (2023) Heart failure remote monitoring: a review and implementation how-to. J Clin Med 12(19):6200

Article  PubMed  PubMed Central  Google Scholar 

Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB (2016) Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet 387(10017):453–61

Gardner RS, Thakur P, Hammill EF, Nair DG, Eldadah Z, Stančák B, Ferrick K, Sriratanasathavorn C, Duray GZ, Wariar R, Zhang Y, An Q, Averina V, Boehmer JP (Apr2021) Multiparameter diagnostic sensor measurements during clinically stable periods and worsening heart failure in ambulatory patients. ESC Heart Fail 8(2):1571–1581

Article  PubMed  PubMed Central  Google Scholar 

Comments (0)

No login
gif