Surgical pericardiotomy to treat heart failure with preserved ejection fraction: a first clinical study
Barry A. Borlaug, Hartzell V. Schaff, Samuel J. Asirvatham, Katlyn E. Koepp, William J. Mauermann, Phillip G. Rowse
Abstract
Patients with heart failure (HF) who have preserved ejection fraction (HFpEF) display elevation in left ventricular (LV) filling pressures during exercise leading to dyspnoea and increased morbidity and mortality.1 High LV filling pressures in HFpEF are caused in part by an extrinsic constraint on the heart mediated by the pericardium, which becomes amplified during exercise,2,3 impairing exercise capacity and increasing risk for HF hospitalization or death.4–6 We have previously shown in animal models and patients without HF undergoing cardiac surgery that pericardiotomy reduces this extrinsic restraint, abrogating the rise in LV filling pressures during volume loading.7–9 Here, we report results from the first clinical trial testing safety and efficacy of surgical pericardiotomy to treat patients with HFpEF. Four individuals with HFpEF [LV ejection fraction (LVEF) ≥ 50%] with severe symptoms despite optimal medical therapy and elevated pulmonary capillary wedge pressure (PCWP) at rest or exercise were enrolled following written informed consent. The Mayo Clinic Institutional Review Board approved the study, and the trial was registered (NCT03923673). Participants underwent echocardiography, cardiac magnetic resonance (CMR) imaging, health status assessment using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS), and cardiopulmonary exercise testing. No statistical analyses were performed, and the results are purely descriptive.