Peter Fail, MD, co-director of the structural heart program at Terrebonne General Medical Center, Houma, Louisiana, explains the use of transcatheter intra-atrial shunts to treat heart failure. He presented on this at the 2022 Transcatheter Valve Therapeutics (TVT) Structural Heart Summit.
Fail was the principal investigator for the recent Corvia intra-atrial shunt device trial. The final data were presented from the 600 patient REDUCE LAP-HF TRIAL II U.S. pivotal trial at the Technology and Heart Failure Therapeutics (THT) 2022 conference in February.
The placement of an atrial shunt device did not reduce the total rate of heart failure events or improve health status in the overall population of patients. However, the study identified a responder group for this first-of-its-kind implantable heart failure therapy. Fail said this may help other inter-atrial shunt devices that are in development or in clinical trials. He said patient selection appears to be a key component, and it is a not a therapy that works for all patients. Fine-tuning the patient selection process will likely show improvement in outcomes.
Corvia said the overall outcome of the trial was neutral, but the data suggests patients with normal exercise pulmonary vascular resistance (PVR) and without a pacemaker represent a responder group for this technology. Fail and the other study authors said these patients derived significant clinical benefit from the shunt therapy, which makes atrial shunting the first implantable therapy to demonstrate effectiveness in patients with heart failure with preserved ejection fraction (HFpEF).
The Corvia Atrial Shunt is the most clinically studied atrial shunt for the reduction of LAP in symptomatic HF patients. It was granted Breakthrough Device designation by the FDA in 2019. It is available for sale in the European Union.
Similar intra-atrial shunt devices have been developed by Noya, Occlutech and VWave. Another approach to this concept of therapy was developed by Alleviant, which uses a catheter to open a hole between the left and right atria without the use of a stent support device. Fail said in animal studies these unsupported shunts have stayed open.
The idea of the shunt is it forms a passage the that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering left atrial pressure in HF patients.
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Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com