Custom‐Fenestrated Atrial Septal Occluder Devices in Borderline Patients With Pulmonary Arterial Hypertension or Restrictive Left Ventricular Physiology

ABSTRACT Background Operability of patients with atrial septal defects (ASD) and pulmonary arterial hypertension (PAH) is guided by various hemodynamic parameters obtained after acute vasodilator testing (AVT). Fenestrated closure is suggested in gray‐zone of operability as well as restrictive left ventricular (LV) physiology. On‐table fenestrations made in the catheterization laboratory close on follow‐up. Nitinol wire braid and fabric are modified in custom‐fenestrated occluders to create a permanent 5−8 mm communication. Aims This retrospective analysis studied patient characteristics and hemodynamics of 33 patients with ASD and PAH or restrictive LV, closed with custom‐fenestrated occluders. Methods Baseline shunt, vascular resistances, and pulmonary/aortic diastolic pressure ratio were measured and repeated after AVT and temporary balloon occlusion. Gray‐zone patients satisfied at least one of the operability parameters. Change in symptoms and hemodynamics, and device patency were assessed on follow‐up. Results Out of the 22 patients with PAH (median age 29.5 years, range 9−66 years) who underwent fenestrated device closure in the last 10 years, 13 had indexed pulmonary vascular resistance > 6 wood units.m 2 ; 7 had a resistance ratio > 0.3, and 12 had a pulmonary/aortic diastolic pressure ratio > 0.4. 21 patients satisfied at least one operability parameter during AVT. In the only patient who did not satisfy any of the parameters, balloon occlusion reduced the PA mean pressure > 25%. During a median follow‐up of 27 months (range 1–106 months), hemodynamics improved in all and fenestration was patent in all patients. Procedural success in 11 patients with restrictive LV (median age 57 years, range 39−69 years) was 91%. Fenestrated occluder was removed immediately in one patient with coronary artery and chronic kidney disease who did not tolerate closure. Patency was maintained on follow‐up, and symptoms improved in all patients. Conclusions Fenestrated occluders allowed ASD closure in gray‐zone patients with PAH and borderline operability as well as restrictive LV physiology. Consistent symptom improvement and atrial decompression by their prolonged patency justified their utility.