Advanced Cardiovascular Specialists in conjunction with CHRISTUS Health in Shreveport, LA on April 5, 2019 has implanted their first patient as part of the landmark GUIDE-HF clinical trial. Advanced Cardiovascular Specialists is one of 140 centers participating in this study. The trial will evaluate improved survival and quality of life with Abbott’s CardioMEMS™ HF System. Heart failure occurs when the heart is unable to pump enough blood to meet the body’s needs. It costs Americans a great deal, not just financially, but in length and quality of life.
Heart failure is the leading cause of hospitalization for Americans over age 65. According to the American Heart Association, nearly 6 million Americans have heart failure and 900,000 new patients are diagnosed each year. The estimated direct and indirect cost of heart failure in the U.S. in 2012 was $31 billion and that number is expected to more than double by 2030. Patients with heart failure are frequently hospitalized, have a reduced quality of life and face a higher risk of death. The Centers for Disease Control and Prevention says that half of heart failure patients die within five years of diagnosis.
“We are very pleased to be one of the 140 centers nationwide participating in this study. This innovative technology is meaningful to improving outcomes, and quality of life for heart failure patients in our community” said Dr. S. Scott Wiggins, MD.
The GUIDE-HF clinical trial is the largest heart failure medical device trial in the U.S. The trial uses Abbott’s CardioMEMS HF System, which supports heart failure management by measuring pulmonary artery pressure (PAP) from within the body. Building on previous clinical trials, the GUIDE-HF trial will study whether the CardioMEMS device can reduce heart failure hospitalization, and improve survival and quality of life for people living with New York Heart Association (NYHA) Class II-IV heart failure.
“Since the first implantable heart monitoring device was used at Advanced Cardiovascular Specialists, hundreds of patients have benefited from this type of therapy. Advanced Cardiovascular Specialists has once again demonstrated its commitment to helping patients in heart failure and investing in innovative medical technology such as the CardioMEMS HF System, a pulmonary artery (PA) pressure monitoring system”, said Dr. S. Scott Wiggins, MD, GUIDE-HF site Principal Investigator. The CardioMEMS HF system, is the only proactive PA pressure monitoring and heart failure (HF) management technology with positive clinical outcomes supported by multicenter randomized clinical data.
The GUIDE-HF clinical trial is an investigational device exemption (IDE) study that began in March of 2018 and will continue through 2023. GUIDE-HF will enroll more than 3,600 patients at 140 hospitals around the U.S. Additionally, if successful, the study will expand coverage to a larger group of at-risk heart failure patients.
CardioMEMS HF System
The CardioMEMS HF System, from global medical device manufacturer Abbott, is approved by the U.S. Food and Drug Administration (FDA) for commercial use in the U.S. The CardioMEMS sensor is designed to last the lifetime of the patient and doesn’t require batteries. Once implanted, the wireless sensor sends pressure readings to an external patient electronic system. There is no pain or sensation for the patient during the readings. The CardioMEMS HF System allows the patients to transmit critical information about their heart failure status to a clinician on a regular basis, without the need for additional clinic or hospital visits. This provides clinicians with the ability to detect worsening heart failure sooner and adjust treatment to reduce the likelihood that the patient will need to be hospitalized. For more information, visit http://www.heartfailureanswers.com/.
About Advanced Cardiovascular Specialists
Advanced Cardiovascular Specialists was formed with the intent to enhance the level of patient care in our medical community and the surrounding Ark-La-Tex. ACS physicians strive to provide greater access to new innovative technology and cardiovascular care.
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