FRIDAY, Feb. 4, 2022 (HealthDay News) — For patients with heart failure and an ejection fraction greater than or equal to 40 percent, placement of an atrial shunt device does not reduce heart rate. heart failure events, according to a study published online February 1 in The Lancet.
Sanjiv J. Shah, MD, of Northwestern University Feinberg School of Medicine in Chicago, and colleagues randomly assigned patients with symptomatic heart failure and an ejection fraction of at least 40% to a shunt device auricular (314 patients) or a sham procedure (312 patients). The primary composite outcome was cardiovascular death or nonfatal ischemic stroke at 12 months, total heart failure event rate through 24 months, and change in Kansas Cardiomyopathy Questionnaire Global Score City at 12 months.
The researchers found that the groups did not differ significantly in terms of the primary composite endpoint (gain ratio, 1.0; 95% confidence interval, 0.8 to 1.2; P = 0.85) or individual components of the composite endpoint. A differential effect of atrial shunt device treatment on heart failure events was observed in prespecified subgroups of pulmonary artery systolic pressure at 20 W of cycling exercise, right atrial volume index and gender (results worse for > 70 mm Hg, ≥ 29.7 mL/m2and men, respectively).
“While the overall trial was neutral, in our subgroup analyzes we found that what happens to the heart and lungs during exercise is of paramount importance in this type of heart failure” , Shah said in a statement.
Several authors disclosed financial ties to pharmaceutical and medical device companies, including Corvia Medical, which funded the study.