Chapter 70
Implantable Hemodynamic Monitoring Systems
Kiran Mahmood,
Noah Moss,
Kiran Mahmood
Search for more papers by this authorKiran Mahmood,
Noah Moss,
Kiran Mahmood
Search for more papers by this authorBook Editor(s):George D. Dangas MD, MACC, MSCAI, FAHA, FESC,
Carlo Di Mario MD, PhD, FRCP, FACC, FSCAI, FESC,
Holger Thiele MD,
Peter Barlis MBBS, MPH, PHD, FACC, FESC, FRACP,
Tayo Addo MD, Bimmer Claessen MD, Christian Hengstenberg MD, Nicholas Kipshidze MD,
George D. Dangas MD, MACC, MSCAI, FAHA, FESC
Professor of Medicine (Cardiology) & Surgery (Vascular) Professor of Cardiology Adjunct Professor of Internal Medicine
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY, USA
National Kapodistrian University of Athens, Greece
Medical University of Vienna, Austria
Search for more papers by this authorCarlo Di Mario MD, PhD, FRCP, FACC, FSCAI, FESC
Professor of Cardiology Director of the Structural Interventional Cardiology Division Honorary Consultant
University of Florence
University Hospital Careggi, Florence, Italy
Cardiologist Royal Brompton Hospital, London, UK
Search for more papers by this authorHolger Thiele MD
Professor of Cardiology at University of Leipzig
Heart Center Leipzig at University of Leipzig, Leipzig, Germany
Search for more papers by this authorPeter Barlis MBBS, MPH, PHD, FACC, FESC, FRACP
Professor of Cardiology Interventional Cardiologist
University of Melbourne, Melbourne, Victoria, Australia
St Vincent's & Northern Hospitals Victoria, Australia
Search for more papers by this authorFirst published: 06 May 2022
Summary
Heart failure hospitalization rates remain high and these hospitalizations are associated with significant costs. Randomized controlled trials of noninvasive telemedical systems have not demonstrated a reduction in hospitalization rates. However, using direct measurements of intracardiac and pulmonary artery pressures to guide heart failure management has been shown to reduce hospitalizations. A large pivotal randomized trial (CHAMPION) demonstrated that heart failure management based on measurements from a direct pulmonary artery pressure monitoring system (CardioMEMS) significantly reduced heart failure hospitalizations. Other platforms utilizing direct hemodynamic monitoring are under development or have ongoing clinical trials. This chapter reviews implantable hemodynamic monitoring systems, specifically the CardioMEMS HF system.
References
- Mozaffarian D , Benjamin EJ , Go AS , et al . Heart disease and stroke statistics–2015 update: a report from the American Heart Association . Circulation 2015 ; 131 : e29 – 322 .
- Jencks SF , Williams MV , Coleman EA . Rehospitalizations among patients in the Medicare fee-for-service program . N Eng J Med 2009 ; 360 : 1418 – 1428 .
- O'Connor CM , Stough WG , Gallup DS , et al . Demographics, clinical characteristics, and outcomes of patients hospitalized for decompensated heart failure: observations from the IMPACT-HF registry . J Card Fail 2005 ; 11 : 200 – 205 .
- Setoguchi S , Stevenson LW , Schneeweiss S . Repeated hospitalizations predict mortlity in the community population with heart failure . Am Heart J 2007 ; 154 : 260 – 266 .
- Lee DS , Austin PC , Stukel TA , et al . “Dose-dependent” impact of recurrent cardiac events on mortality in patients with heart failure . Am J Med 2009 ; 122 : 162 – 169 .e1.
- Shah KS , Xu H , Matsouaka RA , et al . Heart failure with preserved, borderline, and reduced ejection fraction: 5-year outcomes . J Am Coll Cardiol 2017 ; 70 : 2476 – 2486 .
- Lewin J , Ledwidge M , O'Loughlin C , et al . Clinical deterioration in established heart failure: what is the value of BNP and weight gain in aiding diagnosis? Eur J Heart Fail 2005 ; 7 : 953 – 957 .
- Zile MR , Bennett TD , St John Sutton M . Transition from chronic compensated to acute decompensated heart failure: pathophysiological insights obtained from continuous monitoring of intracardiac pressures . Circulation 2008 ; 118 : 1433 – 1441 .
- Davenport C , Cheng EY , Kwok YT , et al . Assessing the diagnostics test accuracy of natriuretic peptides and ECG in the diagnosis of left ventricular systolic dysfunction: a systemic review and meta-analysis . Br J Gen Pract 2005 ; 56 : 48 – 56 .
-
Inglis SC
,
Clark RA
,
McAlister FA
,
et al
.
Structured telephone support or telemonitoring programmes for patients with chronic heart failure
.
Cochrane Database Syst Rev
2010
;
4
:CD007228.
10.1002/14651858.CD007228.pub2 Google Scholar
- Chaudhry SI , Mattera JA , Curtis JP , et al . Telemonitoring in patients with heart failure . N Engl J Med 2010 ; 363 : 2301 – 2309 .
- Koeler F , Winkler S , Schieber M , et al . Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study . Circulation 2011 ; 123 : 1873 – 1880 .
- Bekelman DB , Plomondon ME , Carey EP , et al . Primary results of the patient-centered disease management (PCDM) for heart failure study: a randomized clinical trial . JAMA Intern Med 2015 ; 175 : 725 – 732 .
- Ong MK , Romano PS , Edgington S , et al . 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 ; 176 : 310 – 318 .
- Van Veldhuisen DJ , Braunschweig F , Conraads V , et al . Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure . Circulation 2011 ; 124 : 1719 – 1726 .
- Morgan JM , Kitt S , Gill J , et al . Remote management of heart failure using implantable electronic devices . Eur Heart J 2017 ; 38 : 2352 – 2360 .
- Abraham WT , Perl L . Implantable hemodynamic monitoring for heart failure patients . J Am Coll Cardiol 2017 ; 70 : 389 – 398 .
- Reynolds DW , Bartelt N , Taepke R , et al . Measurement of pulmonary artery diastolic pressure from the right ventricle . J Am Coll Cardiol 1995 ; 25 : 1176 – 1182 .
- Adamson PB , Magalski A , Braunschwieg F , et al . Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system . J Am Coll Cardiol 2003 ; 41 : 565 – 571 .
- Bourge RC , Abraham WT , Adamson PB , et al . Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study . J Am Coll Cardiol 2008 ; 51 : 1073 – 1079 .
- Abraham WT , Adamson PB , Bourge RC , et al . Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial . The Lancet 2011 ; 377 : 658 – 666 .
- Adamson PB , Abraham WT , Bourge RC , et al . Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction . Circ Heart Fail 2014 ; 7 : 935 – 944 .
- Abraham WT , Stevenson LW , Bourge RC , et al . Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial . Lancet 2016 ; 387 : 453 – 461 .
- Adamson PB , Abraham WT , Stevenson LW , et al . Pulmonary artery pressure-guided heart failure management reduces 30–day readmissions . Circ Heart Fail 2016 ; 9 : e002600 .
- Heywood JT , Jermyn R , Shavelle D , et al . Impact of practice-based management of pulmonary artery pressures in 2000 patients implanted with the CardioMEMS sensor . Circulation 2017 ; 135 : 1509 – 1517 .
- Desai AS , Bhimaraj A , Bharmi R , et al . Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in “real-world” clinical practice . J Am Coll Cardiol 2017 ; 69 : 2357 – 2365 .
- Abraham J , Bharmi R , Jonsson O , et al . Association of ambulatory hemodynamic monitoring of heart failure with clinical outcomes in a concurrent matched cohort analysis . JAMA Cardiol 2019 ; 4 : 556 – 563 .
- Shavelle , DM , Desai AS , Abraham WT , et al . Lower rates of heart failure and all-cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure: one-year outcomes from the CardioMEMS post-approval study . Circ Heart Fail 2020 ; 13 : e006863 .
- Angermann CE , Assmus B , Anker SD , et al . Pulmonary artery pressure-guided therapy in ambulatory patients with symptomatic heart failure: the CardioMEMS European monitoring study for heart failure (MEMS-HF) . Eur J Heart Fail 2020 ; 22 : 1891 – 1901 .
- Lindenfeld J , Zile MR , Desai AS , et al . Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial . Lancet 2021 ; 398 : 991 – 1001 .
- Feldman DS , Moazami N , Adamson PB , et al . The utility of a wireless implantable hemodynamic monitoring system in patients requiring mechanical circulatory support . ASAIO J 2018 ; 64 : 301 – 308 .
- Veenis , JF , Radhoe SP , van Miegham NM , et al . Remote hemodynamic guidance before and after left ventricular assist device implantation: short-term results from the HEMO-VAD pilot study . Future Cardiol 2021 ; 17 : 885 – 898 .
-
Thohan V
,
Abraham J
,
Burdorf A
,
et al
.
CardioMEMS pulmonary artery pressure guided management of advanced HF patients supported with a HeartMate LVAD: INTELLECT 2-HF study
.
J Heart Lung Transplant
2021
;
40
:
S91
–
S92
.
10.1016/j.healun.2021.01.1962 Google Scholar
- Abraham J , McCann P , Wang L , et al . Internal jugular vein as alternative access for implantation of a wireless pulmonary artery pressure sensor . Circ Heart Fail 2019 : 12 : e006060 .
- Mullens W , Shariff F , Dupont M , et al . Digital health care solution for proactive heart failure management with the Cordella heart failure system: results of the SIRONA first-in-human study . Eur J Heart Fail 2020 ; 22 : 1912 – 1919 .
- PROACTIVE-HF IDE trial heart failure NYHA class III (PROACTIVE-HF) . https://clinicaltrials.gov/ct2/show/NCT04089059 . NCT04089059.
- Ritzema J , Troughton R , Melton I , et al . Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure . Circulation 2010 ; 121 : 1086 – 1095 .
- Abraham WT , Adamson PB , Costanzo MR , et al . Hemodynamic monitoring in advanced heart failure: results from the LAPTOP-HF trial . J Card Fail 2016 ; 22 : 940 .
-
Perl L
,
Soifer E
,
Bartunek J
,
et al
.
TCT–478 in vivo performance of a novel permanently implanted left atrial pressure monitoring system
.
J Am Coll Cardiol
2018
;
72
:
B191
–
192
.
10.1016/j.jacc.2018.08.1652 Google Scholar
- DiMario C , Sievert K , Meucci F , et al . A novel implantable left atrial pressure sensor in two heart failure patients . EuroIntervenion 2020 [Epub ahead of print].
- V-LAP left atrium monitoring system for patients With chronic systolic and diastolic congestive heart failure (VECTOR-HF) . https://clinicaltrials.gov/ct2/show/NCT03775161 . NCT03775161.
-
Ahn H
,
Baranowski J
.
An implantable pressure sensor for wireless monitoring of intracardiac pressures-first study in man
.
J Card Fail
2016
;
22
:
S68
.
10.1016/j.cardfail.2016.06.216 Google Scholar
- Hubbert L , Baranowski J , Delshad B , et al . Left atrial pressure monitoring with an implantable wireless pressure sensor after implantation of a left ventricular assist device . ASAIO J 2017 ; 63 : e60 – 65 .
- Ponikowski P , Voors AA , Anker SD , et al . 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 (HFA) of the ESC . Eur Heart J 2016 ; 37 : 2129 – 2200 .
- Dickinson MG , Allen LA , Albert NA , et al . Remote monitoring of patients with heart failure: a white paper from the Heart Failure Society of America scientificstatements committee . J Card Fail 2018 ; 24 : 682 – 694 .
