Doctors at Scripps Memorial Hospital La Jolla have become the first in San Diego County to implant a new miniaturized, wireless sensor directly into the heart of patients to manage heart failure following its regulatory approval last May. The CardioMEMS HF System, implanted in three patients by Scripps cardiovascular disease specialists, is the first and only FDA-approved heart failure monitoring device that has been proved to significantly reduce hospital admissions when used by physicians to manage the potentially fatal condition.
The system features a sensor that is implanted in the pulmonary artery during a non-surgical procedure to directly measure pulmonary artery pressure. Increased artery pressures appear first, before weight and blood pressure changes that are often used as indirect measures of worsening heart failure. The new system allows patients to transmit daily sensor readings from their homes to their health care providers, allowing for personalized and proactive management to reduce the likelihood of hospitalization.
“The procedures performed on Jan. 7 with this technology are just the latest examples of Scripps striving to provide the best treatment available and improve outcomes for our heart failure patients,” said Steven Higgins, MD, chairman of the Department of Cardiology at Scripps Memorial La Jolla, who performed one of the implants.
“These procedures also demonstrate Scripps’ commitment to investing in innovative medical technology and solutions for successful patient outcomes in the diagnosis and treatment of heart failure,” he said.
Heart failure occurs when pressures inside the heart increase and produce symptoms such as shortness of breath and lower extremity swelling. According to the Centers for Disease Control and Prevention, more than 5.1 million people in the United States have heart failure, with 670,000 new cases diagnosed each year. Patients with heart failure frequently are hospitalized, have a reduced quality of life and face a higher risk of death.
Sally Wedehase, a resident of Canyon Lake in Riverside County, was one of the first Scripps patients to receive the implant. The 71-year-old lived a very active life until she developed high blood pressure and breathing difficulty. “I was like the Energizer bunny and I had just one speed,” Wedehase said. She visited her doctor when she began having shortness of breath and edema, swelling from a buildup of fluid in her body. In January 2013, she was diagnosed with atrial fibrillation, a type of irregular heartbeat that can lead to heart failure.
While on vacation with her husband last fall, Wedehase once again struggled to breathe. At a subsequent appointment with her doctor, she had 1,050 ml of fluid drained from her lungs. Her pulmonologist recommended she see Thomas Heywood, MD, director of the heart failure program at Scripps Memorial La Jolla and Scripps Green hospitals. “I told him that I realize I’m not as bad off as a lot of people, but I just want some of my life back,” Wedehase said. “Dr. Heywood said he could do that. He could help me.”
The night before her procedure, Wedehase marveled at the dime-sized CardioMEMS. “I can’t believe that technology is going to be a part of me and help me.”
“CardioMEMS will allow us to continually monitor her condition and detect how she is responding to therapies such as medications and life style changes,” said Heywood, who performed Wedehase’s implant. “This is breakthrough technology, never wearing out, while keeping heart failure patients out of the hospital.”
Wedehase is excited the implant will allow her to resume an active lifestyle, beginning with a cruise with her girlfriends next week. “I’ve still got plenty of life to live,” she said.
The sensor is designed to last the lifetime of the patient. It is powered by radio frequency energy that does not require batteries. Once implanted, the wireless device sends pressure readings to an external electronic system. There is no pain or sensation for the patient during the readings, which take a few minutes in the comfort of the patient’s home.
Data from a clinical trial showed that the wireless device reduces heart failure hospital admissions by up to 37 percent. Results of the trial demonstrated a statistically significant 28 percent reduction in the rate of heart failure hospitalizations at six months, and 37 percent reduction in heart failure hospitalizations during an average follow-up duration of 15 months.
According to the American Heart Association, the estimated direct and indirect cost of heart failure in the United States was $31 billion in 2012, and that number is expected to more than double by 2030.
The wireless sensor implants are an extension of Scripps’ leadership in heart care and research. The $456 million Prebys Cardiovascular Institute is scheduled to open in March. It will be a center for innovation that will bring together top researchers, physicians and staff. The institute will incorporate leading-edge wireless technologies and individualized medicine for the best in patient care.
Each year more than 76,000 patients receive their cardiovascular care from Scripps, making it San Diego County’s largest heart care provider. Scripps is the only heart care provider in the region consistently recognized by U.S. News & World Report as one of the best in the country.
Learn more about Scripps Health, a nonprofit integrated health system in San Diego, Calif.