For an all-comer population with any impairment of LV function, an interarterial shunt device missed the primary endpoint in RELIEVE-HF, but benefit was seen with LVEF less than 40%.
in pilot studies, an interarterial shunt device did not meet the primary composite efficacy endpoint in a pivotal trial, a result stemming from apparent harm among the subgroup with preserved left ventricular ejection fraction .
Documented HF for at least 6 months and being on guideline-directed medical therapy for HF were inclusion criteria. Severe valve lesions, severe, and significant right ventricular dysfunction were among exclusion criteria. Anatomical anomalies incompatible with IAS and hemodynamic instability were also exclusion criteria.
The reason, according to Stone, is that blood shunted to the right chamber can be accommodated in the larger compliant hearts of the HFrEF population but not in the smaller and relatively stiff hearts of those with HFpEF. He believes the relative differences in the resilience of the two types of HF to change in blood flow explains the results. Ultimately, despite the design of the trial, the outcomes show that the HFrEF and HFpEF populations turned out "not to be poolable," Stone said.
Patrick T. O'Gara, MD, chair of cardiology at Brigham and Women's Hospital, Boston, Massachusetts, agreed that "there is something there," referring to a benefit from the IAS device in HFrEF patients in this trial. However, referring to the negative outcome of the primary hypothesis, he indicated a routine role in patient management will require further studies that confirm a benefit in the HFrEF subgroup.
Ejection Fraction EF - Ejection Fraction Left Ventricular Ejection Fraction LVEF Cardiomyopathy Transplantation Of The Heart Cardiac Transplantation Heart Transplantation Heart Pulmonary Hypertension
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