May 20, 2022 — Results of the early clinical evaluation of the Lightening system to treat heart failure patients with preserved and reduced ejection fraction (HFpEF and HFrEF) was presented as late-breaking clinical research at the Society of Angiography and Cardiovascular Procedures (SCAI) Scientific Sessions 2022. This multicenter evaluation on three trial programs (ALLEVIATE-HF-1HF-2 and HFrEF) demonstrated the safety and feasibility of the procedure with a promising efficacy signal for six months.
Affecting more than 26 million people worldwide, heart failure occurs when the heart muscle is unable to pump efficiently enough to meet the body’s need for blood and oxygen (NLM). Currently, guidelines recommend medical treatment for heart failure patients with HFpEF and HFrEF, but some remain symptomatic despite optimal medical treatment. The Alleviant System is a transcatheter technology designed to reduce pressure in the left atrium through the creation of a therapeutic interatrial shunt without a permanent heart implant or open-heart surgery.
Patients aged ≥ 40 years old, New York Heart Association (NYHA) Class II, III, or IV outpatients with high PCWP peak exercise were included in the study. Baseline screening included echocardiography, right heart stress catheterization, KCCQ, and 6MWT. Following a transseptal puncture, the Alleviant device was inserted into the femoral vein (located near the groin), advanced to the heart, and powered with a short pulse of radiofrequency energy to remove a segment of the interatrial septum – a thin wall of tissue that separates the right and left atria from the heart. The procedures were performed under fluoroscopic and echocardiographic control.
To date, 31 patients have been followed for three months and 15 patients for six months. Mean peak PCWP exertion decreased from baseline to one month in all studies. A significant increase in the global KCCQ score was observed at six months in study HF-1 and at three months in studies HF-2 and HFrEF. Echocardiography confirmed that all evaluated shunts remained patent at one, three and six months; In addition, 10 patients completed a one-year follow-up with confirmed shunt patency. Investigators and the research team will continue to evaluate the Alleviant system as they collect ongoing follow-up data.
“Unfortunately, we know that this group of heart failure patients currently have limited treatment options,” said Colin M. Barker, MD, FSCAIdirector of the cardiac catheterization laboratory, Vanderbilt University Medical Center in Nashville, Tennessee and lead author of the study. “These early data are promising and show that we are on the right track in developing a safe and effective new approach, without the burden of an implant, to help meet the unique needs of this large and underserved patient population.”
Alleviant Medical is preparing to sponsor a large, prospective, randomized, sham, multinational trial of its implant-free interatrial shunt device in the treatment of patients with HFpEF. Results from the recently published REDUCE LAP-HF II pivotal study underscore the importance of appropriate patient selection and have informed the design of the company’s next pivotal study. Recruitment is expected to begin later this year.
“Alleviant is committed to partnering with clinicians around the world in the continued development of strong clinical evidence with an implant-free atrial shunt procedure for patients with heart failure,” said Adam L. BermanCEO of Alleviant Medical.
For more information: www.scai.org
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