Crain's New York Business
September 2, 2016
Dr. Rita Jermyn, Director, Congestive Heart Failure Program, North Shore University Hospital
A number of New York City area hospitals are turning to an implantable device that's the size of a paper clip to improve their treatment of heart-failure patients and prevent future hospitalizations.
Good Samaritan Hospital in West Islip, L.I., became the latest local hospital to start using the CardioMEMS system, a remote monitoring device for patients with New York Heart Association Class III heart failure who have been hospitalized within the past year.
The device is implanted in a nonsurgical procedure, where doctors insert a catheter into the femoral vein in the upper thigh and then use a fluoroscope to guide the placement of the device into the pulmonary artery. Patients take daily readings of their blood pressure and heart rate at home using a bedside unit, which transmits the data to their physicians through a secure website.
"The results we expect to see are that patients are managed at home, and we decrease or eliminate the ER visits that they have," said Theresa Adair, Good Samaritan's director of cardiovascular services.
The device, sold by St. Paul, Minn.-based St. Jude Medical, was approved by the FDA in May 2014, and NYU Langone Medical Center became the first hospital in the Northeast to implant it in a patient later that year. It's now in use at other health systems including Northwell Health and Mount Sinai. Catholic Health Services' St. Francis Hospital announced its use of the device in April 2015.
A clinical trial, the results of which were published in 2011, showed the device was able to reduce heart failure hospitalizations by 37% during an average follow-up period of 15 months. In 98.6% of cases, there were no complications from the device or system.
Separately, Northwell Health followed 66 patients with Class III heart failure, implanting the device in 34 people, while 32 underwent traditional medical management with patients monitoring their weight and reporting back to doctors during frequent follow-up visits. The patients with the device rated their quality of life three times higher than the control group and were able to walk 38% farther in a six-minute walk test.
Northwell currently is monitoring about 100 patients with the device. The health system uses a registered nurse specializing in heart failure to collect the data. An algorithm created by Dr. Jermyn recommends medication adjustments.
"I see how heart failure monitoring has functioned in the past and it's not working," said Dr. Rita Jermyn, director of North Shore University Hospital's congestive heart failure program. "This has been the first product that has changed how we managed these patients."
But the device has limitations. Its ability to help a large number of heart failure patients is limited by the burden placed on institutions to analyze data and make medication decisions using that information, said Dr. Alex Reyentovich, the clinical director of NYU Langone's heart failure program.
NYU Langone currently has 12 patients using the device. If the devices were put into all patients with chronic heart failure, "it would be incredibly costly and hard to monitor," Reyentovich said.
Some critics have questioned the device's price tag of about $18,000. The Institute for Clinical and Economic Review, a Boston health care research nonprofit that evaluates the cost of new drugs and devices, said in December 2015 that CardioMEMS "represents low care value as a result of uncertainties over the magnitude of benefit provided by the device." The organization set a value-based price benchmark of $10,665, a 40% discount from the list price.
But Good Samaritan's Adair said she believed the device was worth the price, given the cost of a hospital admission or ER visit and subsequent medical testing that is unnecessary because of the data transmitted by the device.—J.L.