A profile on the CardioMEMS HF system in the management of patients with early stages of heart failure: an update

References

• Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139–e596. doi: 10.1161/CIR.0000000000000757
   PubMed Web of Science ®Google Scholar
• Ambrosy AP, Fonarow GC, Butler J, et al. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014;63(12):1123–1133. doi: 10.1016/j.jacc.2013.11.053
   PubMed Web of Science ®Google Scholar
• 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(9):1086–1095. doi: 10.1161/CIRCULATIONAHA.108.800490
   PubMed Web of Science ®Google Scholar
• Mangi MA, Nesheiwat Z, Kahloon R, et al. CardioMEMS TM system in the daily management of heart failure: review of current data and technique of implantation. Expert Rev Med Devices. 2020;17(7):637–648. doi :10.1080/17434440.2020.1779588
   PubMed Web of Science ®Google Scholar
• Ziaeian B, Fonarow GC. The Prevention of hospital readmissions in heart failure. Prog Cardiovasc Dis. 2016;58(4):379–385. doi: 10.1016/j.pcad.2015.09.004
   PubMed Web of Science ®Google Scholar
• Mangi MA, Rehman H, Rafique M, et al. Ambulatory heart failure monitoring: a systemic review. Cureus, 2017. 9(4): e1174.
   PubMed Web of Science ®Google Scholar
• Bohm M, Drexler H, Oswald H, et al. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J. 2016;37(41):3154–3163. doi: 10.1093/eurheartj/ehw099
   PubMed Web of Science ®Google Scholar
• Hindricks G, Taborsky M, Glikson M, et al. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014;384(9943):583–590. doi: 10.1016/S0140-6736(14)61176-4
   PubMed Web of Science ®Google Scholar
• Morgan JM, Kitt S, Gill J, et al. Remote management of heart failure using implantable electronic devices. Eur Heart J. 2017;38(30):2352–2360. doi: 10.1093/eurheartj/ehx227
   PubMed Web of Science ®Google Scholar
• Kato M, Stevenson LW, Palardy M, et al. The worst symptom as defined by patients during heart failure hospitalization: implications for response to therapy. J Card Fail. 2012;18(7):524–533. doi: 10.1016/j.cardfail.2012.04.012
   PubMed Web of Science ®Google Scholar
• Damman K, van Deursen VM, Navis G, et al. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009;53(7):582–588. doi: 10.1016/j.jacc.2008.08.080
   PubMed Web of Science ®Google Scholar
• Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011;377(9766):658–666. doi: 10.1016/S0140-6736(11)60101-3
   PubMed Web of Science ®Google Scholar
• Abraham WT, Stevenson L, Bourge R, 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(10017):453–461. doi: 10.1016/S0140-6736(15)00723-0
   PubMed Web of Science ®Google Scholar
• 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(10):1891–1901. doi: 10.1002/ejhf.1943
   PubMed Web of Science ®Google Scholar
• Lindenfeld J, Zile MR, Desai AS, et al. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021;398(10304):991–1001. doi: 10.1016/S0140-6736(21)01754-2
   PubMed Web of Science ®Google Scholar
• 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(8):e006863. doi: 10.1161/CIRCHEARTFAILURE.119.006863
   PubMed Web of Science ®Google Scholar
• Adamson PB. Pathophysiology of the transition from chronic compensated and acute decompensated heart failure: new insights from continuous monitoring devices. Curr Heart Fail Rep. 2009;6(4):287–292. doi: 10.1007/s11897-009-0039-z
   PubMedGoogle Scholar
• Klein L. (Re)discovering the neurohormonal and hemodynamic duality of heart failure. J Am Coll Cardiol. 2017;70(15):1887–1889. doi: 10.1016/j.jacc.2017.08.058
   PubMed Web of Science ®Google Scholar
• Zile MR, Bennett T, El Hajj S, et al. Intracardiac pressures measured using an implantable hemodynamic monitor: relationship to mortality in patients with chronic heart failure. Circ Heart Fail. 2017;10(1). doi: 10.1161/CIRCHEARTFAILURE.116.003594
   Web of Science ®Google Scholar
• Benza RL, Raina A, Abraham WT, et al. Pulmonary hypertension related to left heart disease: insight from a wireless implantable hemodynamic monitor. J Heart Lung Transplant. 2015;34(3):329–337. doi: 10.1016/j.healun.2014.04.014
   PubMed Web of Science ®Google Scholar
• 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(16):1509–1517. doi: 10.1161/CIRCULATIONAHA.116.026184
   PubMed Web of Science ®Google Scholar
• Givertz MM, Stevenson LW, Costanzo MR, et al. Pulmonary artery pressure-guided management of patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. 2017;70(15):1875–1886. doi: 10.1016/j.jacc.2017.08.010
   PubMed Web of Science ®Google Scholar
• 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(6):556–563. doi: 10.1001/jamacardio.2019.1384
   PubMed Web of Science ®Google Scholar
• Raina A, Abraham WT, Adamson PB, et al. Limitations of right heart catheterization in the diagnosis and risk stratification of patients with pulmonary hypertension related to left heart disease: insights from a wireless pulmonary artery pressure monitoring system. J Heart Lung Transplant. 2015;34(3):438–447. doi: 10.1016/j.healun.2015.01.983
   PubMed Web of Science ®Google Scholar
• 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(19):2357–2365. doi: 10.1016/j.jacc.2017.03.009
   PubMed Web of Science ®Google Scholar
• 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(6):935–944. doi: 10.1161/CIRCHEARTFAILURE.113.001229
   PubMed Web of Science ®Google Scholar
• Adamson PB, Abraham WT, Stevenson LW, et al. Pulmonary Artery Pressure–Guided Heart Failure Management Reduces 30-Day Readmissions. Circ Heart Fail. 2016;9(6). doi: 10.1161/CIRCHEARTFAILURE.115.002600
   PubMed Web of Science ®Google Scholar
• Jermyn R, Alam A, Kvasic J, et al. Hemodynamic-guided heart-failure management using a wireless implantable sensor: infrastructure, methods, and results in a community heart failure disease-management program. Clin Cardiol. 2017;40(3):170–176. doi: 10.1002/clc.22643
   PubMed Web of Science ®Google Scholar
• Assaad M, Singh R, Sarsam S, et al. Impact of CardioMEMS device placement on lifestyle modifications: a “pseudo-placebo” effect beyond the expected? J Int Med Res. 2018;46(8):3195–3199. doi: 10.1177/0300060518774123
   PubMed Web of Science ®Google Scholar
• Assaad M, Sarsam S, Naqvi A, et al. CardioMems® device implantation reduces repeat hospitalizations in heart failure patients: a single center experience. JRSM Cardiovasc Dis. 2019;8:2048004019833290. doi: 10.1177/2048004019833290
   Web of Science ®Google Scholar
• Zile MR, Mehra MR, Ducharme A, et al. Hemodynamically-Guided Management of Heart Failure Across the Ejection Fraction Spectrum: the GUIDE-HF Trial. JACC Heart Fail. 2022;10(12):931–944. doi: 10.1016/j.jchf.2022.08.012
   PubMed Web of Science ®Google Scholar
• Heywood JT, Zalawadiya S, Bourge RC, et al. Sustained Reduction in Pulmonary Artery Pressures and Hospitalizations During 2 Years of Ambulatory Monitoring. J Card Fail. 2023;29(1):56–66. doi: 10.1016/j.cardfail.2022.10.422
   PubMed Web of Science ®Google Scholar
• Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: a Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017;70(6):776–803. doi: 10.1016/j.jacc.2017.04.025
   PubMed Web of Science ®Google Scholar
• Hershberger RE, Nauman D, Walker TL, et al. Care processes and clinical outcomes of continuous outpatient support with inotropes (COSI) in patients with refractory endstage heart failure. J Card Fail. 2003;9(3):180–187. doi: 10.1054/jcaf.2003.24
   PubMed Web of Science ®Google Scholar
• Rogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID Trial. J Am Coll Cardiol. 2007;50(8):741–747. doi: 10.1016/j.jacc.2007.03.063
   PubMed Web of Science ®Google Scholar
• Mancini D, Lietz K. Selection of cardiac transplantation candidates in 2010. Circulation. 2010;122(2):173–183. doi: 10.1161/CIRCULATIONAHA.109.858076
   PubMed Web of Science ®Google Scholar
• Miller LW, Guglin M. Patient selection for ventricular assist devices: a moving target. J Am Coll Cardiol. 2013;61(12):1209–1221. doi: 10.1016/j.jacc.2012.08.1029
   PubMed Web of Science ®Google Scholar
• Kirklin JK, Naftel DC, Pagani FD, et al. Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transplant. 2015;34(12):1495–1504. doi: 10.1016/j.healun.2015.10.003
   PubMed Web of Science ®Google Scholar
• 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(3):301–308. doi: 10.1097/MAT.0000000000000670
   PubMed Web of Science ®Google Scholar
• Yandrapalli S, Raza A, Tariq S, et al. Ambulatory pulmonary artery pressure monitoring in advanced heart failure patients. World J Cardiol. 2017;9(1):21–26. doi: 10.4330/wjc.v9.i1.21
   PubMed Web of Science ®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(5):e60–e65. doi: 10.1097/MAT.0000000000000451
   PubMed Web of Science ®Google Scholar
• Kilic A, Katz JN, Joseph SM, et al. Changes in pulmonary artery pressure before and after left ventricular assist device implantation in patients utilizing remote haemodynamic monitoring. ESC Heart Fail. 2019;6(1):138–145. doi: 10.1002/ehf2.12373
   PubMed Web of Science ®Google Scholar
• MAUDE - Manufacturer and User Facility Device Experience. [cited 2017 Aug 25]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
   Google Scholar
• Hoeper MM, Lee SH, Voswinckel R, et al. Complications of right heart catheterization procedures in patients with pulmonary hypertension in experienced centers. J Am Coll Cardiol. 2006;48(12):2546–2552. doi: 10.1016/j.jacc.2006.07.061
   PubMed Web of Science ®Google Scholar
• Binanay C, Califf R, Hasselblad V, et al. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA. 2005;294(13):1625–1633.
   PubMed Web of Science ®Google Scholar
• Vaduganathan M, DeFilippis E, Fonarow G, et al. Postmarketing adverse events related to the CardioMEMS HF system. JAMA Cardiol. 2017;2(11):1277–1279. doi: 10.1001/jamacardio.2017.3791
   PubMed Web of Science ®Google Scholar
• Abbott communication to healthcare professionals regarding important medical device correction. 2023.
   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(8):e006060. doi: 10.1161/CIRCHEARTFAILURE.119.006060
   PubMed Web of Science ®Google Scholar
• Dasa O, Shafiq Q, Ruzieh M, et al. Patient factors but not the use of novel anticoagulants or warfarin are associated with internal jugular vein access-site hematoma after right heart catheterization. J Invasive Cardiol. 2017;29(12):401–403.
   PubMed Web of Science ®Google Scholar
• Versteeg H, Timmermans I, Widdershoven J, et al. Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial. EP Europace. 2019;21(9):1360–1368. doi: 10.1093/europace/euz140
   PubMed Web of Science ®Google Scholar
• Chiu CSL, Timmermans I, Versteeg H, et al. Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial. Europace. 2022;24(2):256–267. doi: 10.1093/europace/euab221
   PubMed Web of Science ®Google Scholar
• 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(11):1073–1079. doi: 10.1016/j.jacc.2007.10.061
   PubMed Web of Science ®Google Scholar
• Maurer MS, Adamson PB, Costanzo MR, et al. Rationale and design of the left atrial pressure monitoring to optimize heart failure therapy study (LAPTOP-HF). J Card Fail. 2015;21(6):479–488. doi: 10.1016/j.cardfail.2015.04.012
   PubMed Web of Science ®Google Scholar
• Verdejo HE, Castro PF, Concepción R, et al. Comparison of a radiofrequency-based wireless pressure sensor to swan-ganz catheter and echocardiography for ambulatory assessment of pulmonary artery pressure in heart failure. J Am Coll Cardiol. 2007;50(25):2375–2382. doi: 10.1016/j.jacc.2007.06.061
   PubMed Web of Science ®Google Scholar
• Perl L, Meerkin D, D’Amario D, et al. The V-LAP system for remote left atrial pressure monitoring of patients with heart failure: remote left atrial pressure monitoring. J Card Fail. 2022;28(6):963–972. doi: 10.1016/j.cardfail.2021.12.019
   PubMed Web of Science ®Google Scholar
• Mullens W, Sharif 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(10):1912–1919. doi: 10.1002/ejhf.1870
   PubMed Web of Science ®Google Scholar
• Sharif F, Rosenkranz S, Bartunek J, et al. Safety and efficacy of a wireless pulmonary artery pressure sensor: primary endpoint results of the SIRONA 2 clinical trial. ESC Heart Fail. 2022;9(5):2862–2872. doi: 10.1002/ehf2.14006
   PubMed Web of Science ®Google Scholar
• BMAD Trial: Wearable Remote Monitor Reduces Hospital Readmission Risk in HF Patients. Mar 26, 2023. Available from: https://www.acc.org/Latest-in-Cardiology/Articles/2023/03/01/22/45/mon-830am-bmad-acc-2023
   Google Scholar
• Tolia S, Khan Z, Gholkar, G, et al. Validating left ventricular filling pressure measurements in patients with congestive heart failure: CardioMEMS pulmonary arterial diastolic pressure versus left atrial pressure measurement by transthoracic echocardiography. Cardiol Res Pract; 2018. p. 8568356. doi: 10.1155/2018/8568356
   Google Scholar
• Writing Committee M, Members AAJC. 2022 AHA/ACC/HFSA guideline for the management of heart failure. J Card Fail. 2022;28(5):e1–e167. doi: 10.1016/j.cardfail.2022.02.010
   PubMedGoogle Scholar