Subgroup analysis indicates treatment efficacy differed with presence or absence of pulmonary vascular disease unmasked by exercise
FRIDAY, Feb. 4, 2022 (HealthDay News) — For patients with heart failure and an ejection fraction of greater than or equal to 40 percent, placement of an atrial shunt device does not reduce the rate of heart failure events, according to a study published online Feb. 1 in The Lancet.
Sanjiv J. Shah, M.D., from the 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 percent to either an atrial shunt device (314 patients) or sham procedure (312 patients). The primary composite outcome was cardiovascular death or nonfatal ischemic stroke at 12 months, rate of total heart failure events up to 24 months, and change in the Kansas City Cardiomyopathy Questionnaire overall summary score at 12 months.
The researchers found that the groups did not differ significantly in terms of the primary composite end point (win ratio, 1.0; 95 percent confidence interval, 0.8 to 1.2; P = 0.85) or in the individual components of the composite end point. A differential effect of atrial shunt device treatment on heart failure events was seen in prespecified subgroups of pulmonary artery systolic pressure at 20W of bicycle exercise, right atrial volume index, and sex (worse outcomes for >70 mm Hg, â¥29.7 mL/m2, and men, respectively).
“While the overall trial was neutral, in our subgroup analyses, we found that what happens in the heart and lungs during exercise is of prime 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.
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