Interatrial Shunt Not Beneficial in a Randomized Trial

In patients with preserved and mildly reduced ejection fraction, there was no reduction in heart failure events.

Decompression of the left atrium to reduce heart failure symptoms with a device that creates a hole (shunt) between the left and right atria has been proposed as a potential treatment. Phase 2 study results of one such interatrial shunt (IAS) device showing reduced heart failure events at 1 year prompted this industry-funded, phase 3, randomized, sham-controlled study in 626 patients with symptomatic heart failure and ejection fraction (EF) of at least 40% (REDUCE LAP-HF II; NCT03088033).

The median age of participants was 72 years, 62% were women, and 93% had preserved EF. The primary hierarchical endpoint of death, stroke, heart failure events (to 2 years), and change in health status score at 1 year did not differ between patients with an…

Reviewing Author

Howard C. Herrmann, MD

Disclosures

Consultant/Advisory BoardAffluent Medical; Artedrone; Caranx; Johnson & Johnson; Medtronic; Prolifagen; Wells Fargo

EquityMicrointerventional Devices, Inc.

RoyaltiesUniversity of Pennsylvania

Grant/Research SupportAbbott Vascular; Edwards Lifesciences; Johnson & Johnson; Medtronic

Editorial BoardsCatheterization and Cardiovascular Interventions; Journal of the American College of Cardiology; Circulation: Cardiovascular Interventions; JACC Cardiovascular Interventions; JACC Case Reports; JSCAI

Leadership Positions in Professional SocietiesHeart Valve Collaboratory (Scientific Committee Member, Chair of the Publications Committee)