Data Show CardioMEMS, HeartMate 3 Helping Extend Lives

New data show remote pressure monitoring helps improve survival in heart failure patients.

Healthy Heart|Mar. 27, 2023

“Living with heart failure.”

So much left unspoken and so often misunderstood.

The quiet part? “Living (for now) with heart failure.” That’s just the progressive nature of the disease.

And the misunderstanding? That a heart has stopped altogether. Or, that it’s so weak, so underperforming, that short of a transplant, living a meaningful life is out of reach.

We can help. For people living with heart failure, CardioMEMS and HeartMate 3 have been shown to provide the precious gift they value most outside of a heart transplant: Quality time.

CardioMEMS Reduces Risk

More than 6.2 million Americans have heart failure.

Diagnoses are projected to double1 by 2030.

How do we even begin?

Let’s start here: Data from a new meta-analysis of three randomized, controlled trials (CHAMPION, GUIDE-HF and LAPTOP-HF) involving 1,350 people living with reduced ejection fraction (HFrEF) heart failure show that remote monitoring technology, like the  CardioMEMS HF System — an early warning system against worsening heart failure that helps doctors more proactively make changes to treatment plans to prevent hospitalizations — can improve survival, reducing their mortality risk by 25% at two years.2

HFrEF occurs when the left ventricle loses its ability to contract normally, the muscle weakens and is unable to pump with enough force to push enough blood into circulation.

The CardioMEMS sensor — no bigger than a paper clip — wirelessly transmits pulmonary artery pressure readings daily that can indicate worsening heart failure, often before symptoms are noticed. It’s connected technology that’s bringing people closer to their healthcare providers to help you feel like you’re in the office without having to leave your home.

“These new findings are encouraging news for physicians and the millions of people living with a progressive disease for which there is no cure,” said Philip B. Adamson, M.D., chief medical officer of Abbott’s heart failure business. “Heart Failure is a growing health crisis that demands innovative solutions.”

Living Longer With HeartMate 3

CardioMEMS is helping more people live longer. That’s terrific news.

But that’s not all. The HeartMate 3 left ventricular assist device (or LVAD, also known as a heart pump) is doing even more.

Five years more, as data from the MOMENTUM 3 study of more than 1,000 people show, thanks to the only commercially approved heart pump with Full MagLev technology, which allows the device’s rotor to be “suspended” by magnetic forces.

More than 20,000 people have benefitted from HeartMate 3. It’s just the start of what’s possible for some of those 6.2 million.3

“There are too many patients who aren’t provided the opportunity to be evaluated for a heart pump,” said Keith Boettiger, vice president of Abbott's heart failure business. “With broader awareness and improved access to a heart pump, we can give these patients a chance at a longer, fuller life.”

Millions and Millions

Longer, fuller lives. Multiple. With the possibility for multitudes.

Lives like Avery’s. And Beth. And Iris. And Tiara.

As well as the lives of those who care for them, so they can rest a little easier knowing that their time together won’t be so short. It’s a commodity too many take for granted, right up until they’re running short.

These technologies are helping more people than ever before. They’re among the countless ways we’re working to reach one in three people around the world to live their best lives by 2030. That’s how we see a sustainable future: One that starts with health.

“Living (for now) with heart failure?”

How about: “Living (more of your life the way you want, and living it longer) with heart failure.”

The time is now. And it comes with the promising potential of regaining in your life what you lost to heart failure.

Say it loud, so everyone can hear.

References

1Circ Heart Fail. 2015;8:880-886. DOI: 10.1161/CIRCHEARTFAILURE.114.001778.

2“Longer Term Effects of Hemodynamic Monitoring on Outcomes: A Combined Data Analysis of HFrEF patients in CHAMPION, GUIDE-HF AND LAPTOP-HF”; Adamson, Costanzo, Desai, Ducharme, Henderson, Johnson, Lindenfeld, Maisel, Mehra, Paul, Sears and Zile; Presented at the THT Conference, Boston, Mass., March 21, 2023.

3Centers for Disease Control and Prevention. Facts About Heart Failure in the United States. Heart Failure | cdc.gov. Accessed Dec. 30, 2021.

IMPORTANT SAFETY INFORMATION

HEARTMATE 3

CARDIOMEMS HF SYSTEM

By Prescription Only

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.

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.

myCardioMEMSxx™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS™ Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS™ App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgment that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.

HEARTMATE 3

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.

 

HeartMate 3™ Left Ventricular Assist System

Indications: The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.

Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events: Adverse events that may be associated with the use of the HeartMate 3™ Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or pump thrombosis.

HeartMate 3 Coring Tool

Indications: For the HeartMate 3 Left Ventricular Assist System (LVAS) Indications for Use, please refer to the HeartMate 3 LVAS Instructions for Use. The HeartMate 3™ Coring Tool is intended for use with the HeartMate 3 LVAS. The HeartMate 3 Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

Contraindications: The use of the HeartMate 3 Coring Tool is contraindicated in patients who are contraindicated for HeartMate 3 Left Ventricular Assist System (LVAS) therapy.

Adverse Events: The following adverse events may be associated with the use of the HeartMate 3 Coring Tool. Adverse events are listed in anticipated decreasing order of frequency, except for death, which appears first as it is a non-reversible complication: death, bleeding (perioperative or late), local infection, local ischemia, cardiac arrhythmia, stroke, peripheral thromboembolic event, neurologic dysfunction, hemolysis, sepsis.