Early Experience and Lessons Learned Using Implanted Hemodynamic Monitoring in Patients With Fontan Circulation

Abstract

Background Data on the use of implanted hemodynamic monitoring (IHM) in patients with Fontan circulation are limited. This study reports our experience using the CardioMEMS HF system in adults with Fontan circulation. Methods and Results This single‐center, retrospective study evaluated heart failure hospitalizations, procedural complications, and device‐related complications in patients with Fontan circulation referred for IHM placement (2015–2022). The association of pulmonary artery pressure (by most recent catheterization and median IHM pressure within 30 days of placement) with both death and follow‐up Model for End‐Stage Liver Disease Excluding International Normalized Ratio score were evaluated. Of 18 patients referred for IHM placement, 17 were successful (median age, 30 [range 21–48] years, 6 women). Procedural complications (access site hematomas, pulmonary artery staining) occurred in 3 patients, without device‐related procedural complications. In follow‐up (median, 35 [range, 6–83] months), 1 patient developed a pulmonary embolism (possibly device‐related). Heart failure hospitalizations/year were similar before and after IHM (median, 1 [interquartile range, 0–1.0] versus 0.6 [0–2.3]; P =0.268), though only 46% of heart failure hospitalizations had associated IHM transmissions. IHM pressures were associated with Model for End‐Stage Liver Disease Excluding International Normalized Ratio scores ( R 2 =0.588, P <0.001), though catheterization pressures were not ( R 2 =0.140, P =0.139). The long‐term mortality rate was 53% in this cohort. On unadjusted survival analysis, IHM pressures ≥18 mm Hg were associated with mortality (log rank P =0.041), which was not reproduced with catheterization pressures (log rank P =0.764). Conclusions In patients with Fontan circulation, IHM did not reduce heart failure hospitalizations, though patient adherence to transmission was low. Device‐related complications were low. IHM pressures may better represent real‐life conditions compared with catheterization given associations with mortality and Model for End‐Stage Liver Disease Excluding International Normalized Ratio score.