Structural Septal Device Relieves Heart Failure Symptoms

After creating a small opening in the atrial septum, the IASD implant is deployed, forming a permanent passage between the atria and facilitating continuous and dynamic decompression of the left atrium. As a result, HF symptoms and quality of life are improved and HF hospitalization rates are reduced.

One-year follow-up data of the IASD clinical study, held in 64 patients implanted at 18 centers in eleven countries, demonstrated shunt patency for all participants who received the implant. Study endpoints, as measured by exercise pulmonary capillary wedge pressure (PCWP) reduction, showed a reduction in New York Heart Association (NYHA) class. Procedural safety, assessed by major adverse cardiovascular, cerebral, or renal events (MACCRE), showed that the IASD is also safe. The study was presented at the European Society of Cardiology (ESC) annual congress, held during August 2018 in Munich (Germany).

“The clinical study is of tremendous interest to me, because HFpEF is a clinical problem for which there is no effective therapy,” said co-lead author and study presenter Ted Feldman, MD, of Evanston Hospital (IL, USA). “We've now studied the IASD in several consecutive trials. The early single-arm studies demonstrated that people felt better and their exercise capacity improved. Now, a sham-controlled randomized study conclusively proves the mechanism of action and again suggests clinical efficacy in midterm follow-up.”

HFpEF accounts for approximately 50% of all HF, affecting more than 6.2 million people in the United States and Europe, but treatment options remain limited, consisting mainly of diuretics and fluid balance control. People with HFpEF suffer from difficulty breathing, find simple daily activities tiring (if not impossible), and are frequently hospitalized, with a resultant dramatic reduction in their quality of life. Although the pathophysiology of HFpEF is complex, many of the symptoms are a result of excessive rises in left atrial pressure, in particular during exercise.

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