Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST

Martin R Cowie, Pascal de Groote, Scott McKenzie, Marie-Elena Brett, Philip B Adamson, CardioMEMS Post-Market Study Investigators, Martin R Cowie, Pascal de Groote, Scott McKenzie, Marie-Elena Brett, Philip B Adamson, CardioMEMS Post-Market Study Investigators

Abstract

Aims: Chronic heart failure reduces quality and quantity of life and is expensive for healthcare systems. Medical treatment relies on guideline-directed therapy, but clinical follow-up and remote management is highly variable and poorly effective. New remote management strategies are needed to maintain clinical stability and avoid hospitalizations for acute decompensation.

Methods and results: The CardioMEMS Post-Market Study is a prospective, international, single-arm, multicentre, open-label study (NCT02954341) designed to examine the feasibility of haemodynamic guided heart failure management using a small pressure sensor permanently implanted in the pulmonary artery (PA). Daily uploaded PA pressures will be reviewed weekly to remotely guide medical management of patients with persistent NYHA Class III symptoms at baseline and a hospitalization in the prior 12 months. The study will enrol up to 800 patients from 85 sites across the United Kingdom, Europe, and Australia. The primary safety endpoint will assess device or system-related complications or sensor failures after 2 years of follow-up. Efficacy will be estimated after 1 year of follow-up comparing HF hospitalization rates before and after sensor implantation. Observational endpoints will include mortality, patient, and investigator monitoring compliance, PA pressure changes, quality of life, and several pre-defined subgroup analyses.

Conclusions: The CardioMEMS Post-Market Study will investigate the generalizability of remote haemodynamic guided HF management in a number of national settings. The results may support the more widespread implementation of this novel clinical management approach.

Keywords: CardioMEMSTM HF System; Clinical trial; Haemodynamic monitoring; Heart Failure; Pulmonary artery pressure.

© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
The CardioMEMS TM HF System sensor is permanently implanted into the distal pulmonary artery (PA) using transcatheter techniques in the catheterization laboratory (A); the sensor baseline is set to the mean PA pressure using a pulmonary artery catheter. Daily PA haemodynamic measurements are taken by the patient in a supine position at home. The patient measurement system consists of an antenna and electronics unit that guides the patient through the short reading process (B). The data can be recorded from the home, hospital, physician's office, or clinic. The haemodynamic data is transmitted to the website which is accessible via a secure website to the patient's heart failure clinician (C).

References

    1. Chioncel O, Lainscak M, Seferovic PM, Anker SD, Crespo‐Leiro MG, Harjola VP, Parissis J, Laroche C, Piepoli MF, Fonseca C, Mebazaa A, Lund L, Ambrosio GA, Coats AJ, Ferrari R, Ruschitzka F, Maggioni AP, Filippatos G. Epidemiology and one‐year outcomes in patients with chronic heart failure and preserved, mid‐range and reduced ejection fraction: an analysis of the ESC heart failure long‐term registry. Eur J Heart Fail 2017; 19: 1574–1585.
    1. Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González‐Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P, ESC Scientific Document Group . 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association of the ESC. Eur J Heart Fail 2016; 18: 891–975.
    1. Atherton JJ, Sindone A, De Pasquale CG, Driscoll A, MacDonald PS, Hopper I, Kistler PM, Briffa T, Wong J, Abhayaratna W, Thomas L, Audehm R, Newton P, O'Loughlin J, Branagan M, Connell C. National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: guidelines for the prevention, detection and management of heart failure in Australia 2018. Heart Lung Circ 2018; 27: 1120–1208.
    1. Zile MR, Bennett TD, St. John Sutton M, Cho YK, Adamson PB, Aaron MF, Aranda JM Jr, Abraham WT, Smart FW, Stevenson LW, Keuffer FJ, Bourge RC. Transition from chronic compensated to acute decompensated heart failure: pathophysiological insights obtained from continuous monitoring of intracardiac pressures. Circulation 2008; 118: 1433–1441.
    1. Zile MR, Bennett TD, El Hajj E, Kueffer FJ, Baicu CF, Abraham WT, Bourge RC, Stevenson LW. Intracardiac pressures measured using an implantable hemodynamic monitor. relationship to mortality in patients with chronic heart failure. Circ Heart Fail 2017; 10: e003594.
    1. Stevenson LW, Zile MR, Bennett RD, Kueffer FJ, Jessup ML, Adamson P, Abraham WT, Manda V, Bourge RC. Chronic ambulatory intracardiac pressures and future heart failure events. Circ Heart Fail 2010; 3: 580–587.
    1. Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Pieper K, Sun JL, Yancy CW, Young JB, OPTIMIZE‐HF Investigators and hospitals . Factors identified as precipitating hospital admission for heart failure and clinical outcomes: findings from OPTIMIZE‐HF. Arch Intern Med 2008; 168: 847–854.
    1. Cleland JG, Louis AA, Rigby AS, Hanssens U, Balk H. Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: The Trans‐European Network‐Home‐Care Management System (TEN‐HMS) study. J Am Coll Cardiol 2005; 45: 1654–1664.
    1. Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC, Effectiveness After Transition–Heart Failure (BEAT‐HF) Research Group . Effectiveness of remote patient monitoring after discharge of hospitalized patients with heart failure: the Better Effectiveness After Transition‐Heart Failure (BEAT‐HF) randomized clinical trial. JAMA Intern Med 2016; 76: 310–318.
    1. Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med 2010; 363: 2301–2309.
    1. Angermann CE, Stork S, Gelbrich G, Faller H, Jahns R, Frantz S, Loeffler M, Ertl G, Competence Network Heart Failure . Mode of action and effects of standardized collaborative disease management on mortality and morbidity in patients with systolic heart failure: the Interdisciplinary Network for Heart Failure (INH) study. Circ Heart Fail 2012; 5: 25.
    1. Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan B‐A, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Störk S, Butter C, Sechtem U, Angermann CE, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM‐HF2): a randomised, controlled, parallel‐group, unmasked trial. Lancet 2018; 392: 1047–1057.
    1. Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston‐Miller N, Januzzi JL Jr, Mark DB, Piña IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne‐Nickens P, O'Connor CM. Effect of natriuretic peptide–guided therapy on hospitalization or cardiovascular mortality in high‐risk patients with heart failure and reduced ejection fraction: a randomized clinical trial. JAMA 2017; 318: 713–720.
    1. Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Sogaard P, group* I‐Ts . Implant‐based multiparameter telemonitoring of patients with heart failure (IN‐TIME): a randomised controlled trial. Lancet 2014; 384: 583–590.
    1. Bohm M, Drexler H, Oswald H, Rybak K, Bosch R, Butter C, Klein G, Gerritse B, Monteiro J, Israel C, Bimmel D, Kaab S, Huegl B, Brachmann J, OptiLink HFSI . Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J 2016; 37: 3154–3163.
    1. van Veldhuisen DJ, Braunschweig F, Conraads V, Ford I, Cowie MR, Jondeau G, Kautzner J, Aguilera RM, Lunati M, Yu CM, Gerritse B, Borggrefe M, DOT‐HF Investigators . Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure. Circulation 2011; 124: 1719–1726.
    1. Morgan JM, Kitt S, Gill J, McComb JM, Ng GA, Raftery J, Roderick P, Seed A, Williams SG, Witte KK, Wright DJ, Harris S, Cowie MR. Remote management of heart failure using implantable electronic devices. Eur Heart J 2017; 38: 2352–2360.
    1. Conraads VM, Ravazzi L, Santini M, Oliva F, Gerritse B, Yu CM, Cowie MR. Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE‐HF trial. Eur Heart J 2011; 32: 2266–2273.
    1. Cowie MR, Bax J, Bruning N, Cleland JG, Koeler F, Malik M, Pinto F, van der Velde E, Vardas P. e‐Health: a position statement of the European Society of Cardiology. Eur Heart J 2016; 37: 63–66.
    1. Adamson PB, Abraham WT, Aaron M, Aranda JM, Bourge RC, Smith A, Stevenson LW, Yadav J. CHAMPION trial rationale and design: the long‐term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. J Card Fail 2010; 17: 3–10.
    1. Abraham WT, Adamson PB, Bourge RC, Aaron M, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav J, for the CHAMPION Trial Study Group . Wireless pulmonary artery hemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 2011; 377: 658–666.
    1. Adamson PB, Abraham WT, Bourge RC, Costanzo MR, Hasan A, Yadav C, Henderson J, Cowart P, Stevenson LW. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circ Heart Fail 2014; 7: 935–944.
    1. Givertz MM, Stevenson LW, Costanzo MR, Bourge RC, Bauman JG, Ginn G, Abraham WT, CHAMPION Trial Investigators . Pulmonary artery pressure‐guided management of patients with heart failure and reduced ejection fraction. J Am Coll Cardiol 2017; 70: 1875–1876.
    1. Heywood JT, Jermyn R, Shavelle D, Abraham WT, Bhimaraj A, Bhatt K, Sheikh F, Eichorn E, Lamba S, Bharmi R, Agarwal R, Kumar C, Stevenson LW. Impact of practice‐based management of pulmonary artery pressures in 2000 patients implanted with the CardioMEMS Sensor. Circulation 2017; 135: 1509–1517.
    1. Desai AS, Bhimaraj A, Bharmi R, Jermyn R, Bhatt K, Shavelle D, Redfield MM, Hull R, Pelzel JA, Davis K, Dalal N, Adamson PB, Heywood JT. Reduction in heart failure hospitalizations with ambulatory hemodynamic monitoring seen in clinical trials is maintained in the ‘Real World’. J Am Coll Cardiol 2017; 69: 2357–2365.
    1. Abraham J, Bharmi R, Jonsson O, Oliveira GH, Artis A, Valika A, Capodilupo R, Adamson PB, Roberts G, Dalal N, Desai A, Benza RL. Association of ambulatory hemodynamic monitoring with clinical outcomes: a concurrent matched control analysis. JAMA Cardiol 2019; 4: 556–563.
    1. Cowie MR, Simon M, Klein L, Thokala P. The cost‐effectiveness of real‐time pulmonary artery pressure monitoring in heart failure patients: a European perspective. Eur J Heart Fail 2017; 19: 661–669.
    1. Angermann CE, Aßmus B, Anker SD, Brachmann J, Ertl G, Köhler F, Rosenkranz S, Tschöpe C, Adamson PB, Böhm M. Safety and feasibility of pulmonary artery pressure‐guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS‐HF). Clin Res Cardiol 2018; 107: 991–1002.
    1. Brugts JJ, Veenis JF, Radhoe SP, Linssen GCM, van Gent M, Borleffs CJW, van Ramshorst J, van Pol P, Tukkie R, Spee RF, Emans ME, Kok W, van Halm V, Handoko L, Beeres SLMA, Post MC, Boersma E, Lenzen MJ, Manintveld OC, Koffijberg H, van Baal P, Versteegh M, Smilde TD, van Heerebeek L, Rienstra M, Mosterd A, Delnot PPH, Asselbergs FW, Brunner‐La Rocca HP, de Boer RA. A randomized comparison of the effect of haemodynamic monitoring with CardioMEMS in addition to standard care on quality of life and hospitalizations in patients with chronic heart failure: Design and rationale of the MONITOR HF multicentre randomised clinical trial. Neth Heart J 2020; 28: 16–26.
    1. Okumura N, Jhund PS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJ, PARADIGM‐HF Investigators and Committees* . Importance of clinical worsening of heart failure treated in the outpatient setting: evidence from the Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial (PARADIGM‐HF). Circulation 2016; 133: 2254–2262.
    1. Desai A, Stevenson LW. Connecting the circle from home to heart‐failure disease management. N Engl J Med 2010; 363: 2364–2367.
    1. Costanzo MR, Stevenson LW, Adamson PB, Desai AS, Heywood JT, Bourge RC, Bauman J, Abraham WT. Interventions linked to decreased heart failure hospitalizations during ambulatory pulmonary artery pressure monitoring. JACC Heart Fail 2016; 4: 333–344.
    1. Lindenfeld JA, Abraham WT, Maisel A, Zile MR, Smart F, Costanzo MR, Mehra MR, Ducharme A, Sears SF, Desai AS, Paul S, Sood P, Johnson N, Ginn G, Adamson PB. Hemodynamic‐GUIDEd Management of Heart Failure (GUIDE‐HF). Am Heart J 2019; 214: 18–27.
    1. Maggioni AP, Dahlstrom U, Filippatos G, Chioncel O, Crespo Leiro M, Drozdz J, Fruhwald F, Gullestad L, Logeart D, Fabbri G, Urso R, Metra M, Parissis J, Persson H, Ponikowski P, Rauchhaus M, Voors AA, Nielsen OW, Zannad F, Tavazzi L, Heart Failure Association of the European Society of Cardiology (HFA) . EURObservational Research Programme: regional differences and 1‐year follow‐up results of the Heart Failure Pilot Survey (ESC‐HF Pilot). Eur J Heart Fail 2013; 15: 808–817.

Source: PubMed

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