Clinical outcome of fenestrated Fontan patients after closure - The first 10 years

Background-The late clinical status of Fontan patients after fenestration c losure is unknown. Data are now available on all patients who underwent clo sure from 1989 to 1999. Methods and Results-All patients who underwent catheter closure of a Fontan fenestration were enrolled in either the Clamshell (1989 to 1994) or Cardi oSEAL (1996 to 1999) regulatory trials. Physiological values obtained at ca theterization helped assess the hemodynamic effects of fenestration occlusi on. Tn addition to survival, outcomes assessed included O-2 saturations, me dication use, significant clinical findings leg, heart failure, protein-los ing enteropathy, or new arrhythmias), and somatic growth. Of 181 patients w ho underwent closure, 27 had additional significant leaks. The remaining 15 4 patients constituted the study group. Median time from closure to latest follow-up was 3.4 years (range 0.4 to 10.3 years). Fenestration closure inc reased O-2 saturation 9.4% on average (P<0.001). The numbers of patients re ceiving digoxin or diuretics decreased at the most recent follow-up compare d with baseline (P<0.001), but use of antiarrhythmic agents increased margi nally (P=0.05). Height and weight percentiles rose (medians of 2 and 4, res pectively; P<0.001), Clinical decompensation during follow-up of 154 patien ts was rare (4.5%), with 2 deaths, 3 Fontan revisions, and 1 patient each w ith protein-losing enteropathy and ascites, No other patient developed chro nic congestive symptoms: 21 patients developed new arrhythmias, and 2 had a stroke or transient ischemic attack. Conclusions-Fenestration closure in Fontan patients was followed by improve d oxygenation, reduced need for anticongestive medication, and improved som atic growth at latest follow-up. Death (1.3%) or chronic decompensation (3. 2%) was rare.