How the CardioMEMS™ HF System is improving outcomes in 40K+ patients with heart failure

Nearly 6.7 million adults in the U.S. have heart failure, with prevalence expected to rise to 8.5 million by 2030^1,2. While heart failure is a chronic, progressive disease, advances in technology are changing the way it is managed. There are tools that can provide patients and their healthcare team with actionable insights to help manage heart failure before it progresses to a later stage.

The Abbott CardioMEMS HF System is one such tool, featuring a paperclip-sized sensor that, once placed in the pulmonary artery during a minimally invasive procedure, monitors for pressure changes that indicate worsening heart failure. The pre-symptomatic data provided by the CardioMEMS HF System allows for proactive changes in medical therapy before heart failure symptoms appear³ – empowering the patient and their care team to manage the condition from virtually anywhere. The Centers for Medicare & Medicaid Services (CMS) added CardioMEMS implantation procedures to the Ambulatory Surgery Center (ASC) Covered Procedures List in the CY 2024 Final Rule for Hospital Outpatient and ASC Payment Systems. As a result, Medicare is now reimbursing CardioMEMS in ASCs with a national average reimbursement of $24,713. It is important to note cardiac ASCs are subject to the state Certificate of Need process; Medicare and Medicare Advantage coverage policies for CardioMEMS still apply to procedures performed in ASCs.

Multiple studies, including three randomized control trials and a meta-analysis have demonstrated significant clinical benefits in over 8,000 heart failure patients. Patients who are monitored with the CardioMEMS HF System experience lower pulmonary artery pressure^4-9, reduced mortality by 25%¹⁰ in reduced ejection fraction (HFrEF) patients, see fewer heart failure hospitalizations by up to 70%¹¹ at two years and significantly improve quality of life⁸.

This year marks 10 years since the FDA approval of the CardioMEMS HF System. Over the past decade, CardioMEMS has helped more than 40,000 patients¹² manage their heart failure.

Recently, Mesa, AZ-based Tri-City Cardiology announced that their ASC is now offering the CardioMEMS HF System. Tri-City has noted that the benefits of CardioMEMS extend beyond early detection and patients encompass a clinically proven improvement in quality of life. They also noted that by preventing heart failure exacerbations and reducing hospitalizations, patients can experience fewer symptoms and regain a sense of independence and mobility. Lastly, Tri-City is confident that the integration of CardioMEMS into mainstream healthcare practices holds the promise of significant cost savings by minimizing the need for emergency interventions and hospitalizations.

This is an exciting milestone as more Medicare patients across various ASC facilities can now access CardioMEMS, enabling improved heart failure outcomes and operational efficiencies in a broader patient base than ever before.

Connect with an Abbott clinical specialist to learn more about the CardioMEMS HF System and recent clinical and real-word data.

1. Centers for Disease Control and Prevention. Facts About Heart Failure in the United States. Heart Failure | cdc.gov.
2. Bozkurt B, Ahmad T, Alexander KM, et al. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023;29(10):1412-1451. doi:10.1016/j.cardfail.2023.07.006
3. Adamson PB, Abraham WT, Bourge RC, Costanzo MR, Hasan A, Yadav C, et al. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circulation: Heart Failure. 2014;7(6):935-944.
4. Heywood JT, Jermyn R, Shavelle D, et al. Impact of practice-based management of PA pressures in 2000 patients implanted with the CardioMEMS sensor. Circulation. 2017;135:1509-17.
5. Angermann C, 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). European J of Heart Failure. 2020;22(10):1891-1901.
6. Shavelle D, Desai A, Abraham W, et al. Lower rates of heart failure and all-cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure. Circulation: Heart Failure. 2020;13(8):229-238.
7. Lindenfeld J, Zile MR, Desai AS, et al. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomized controlled trial. The Lancet. 2021;398:991-1001.
8. Brugts JJ, Radhoe SP, Clephas PRD, et al. Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial [published correction appears in The Lancet. 2023;401(10394):2112]. The Lancet. 2023;401(10394):2113-2123. doi:10.1016/S0140-6736(23)00923-6
9. Mehra, MR, Costanzo, MR, Zile, MR, on behalf of the GUIDE-HF investigators. Primary Results of the Prospective Single Arm Trial of Hemodynamic-Guided Management of Heart Failure (GUIDE-HF). Presented at Heart Failure Society of America, Cleveland, OH, USA, Oct 8, 2023
10. Lindenfeld, J, Costanzo, M, Zile, M. et al. Implantable Hemodynamic Monitors Improve Survival in Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2024 Feb, 83 (6) 682–694.
11. Heywood TT et al. Sustained reduction in pulmonary artery pressures and hospitalizations during 2 years of ambulatory monitoring. J Card Fail. 2023;29(1):56–66.
12. Abbott data on file

 
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Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

CardioMEMS™ HF System Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.

CardioMEMS™ HF System Contraindications: The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant. CardioMEMS™ HF System Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolization, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.

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MAT-2408340 v1.0 | Item approved for U.S. use only.