Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database

ObjectiveAmplatzer (AGA Medical Corporation, Plymouth, Minn) septal and vascular occluder devices have significantly altered the care of patients with congenital heart disease. The relative frequency and consequence of complications resulting from the attempted placement of such devices, however, have not been well assessed. The purpose of this study is to use large databases to assess the frequency and severity of such complications and compare them with those of surgical atrial septal defect closure.MethodsThe US Food and Drug Administration Manufacturer and User Facility Device Experience database was quarried for all adverse events for Amplatzer septal occluder devices, which were categorized and analyzed with particular emphasis on management and outcome. The Society of Thoracic Surgery database was likewise quarried for the same data regarding atrial septal defect closures over a contemporaneous time period. By using a literature-derived denominator for total Amplatzer implant numbers, the results of the 2 therapies were compared.ResultsSince July 1, 2002, 223 adverse events in patients undergoing Amplatzer atrial septal defect closure were submitted to the Food and Drug Administration, resulting in 17 deaths (7.6%) and 152 surgical rescue operations (68.2%). Society of Thoracic Surgery data demonstrated 1537 primary operations with 2 deaths (0.13%) and 6 reoperations (0.39%). By extrapolating on published estimates of Amplatzer implantation to provide an implant denominator (n = 18,333), there was no difference between overall mortality for surgical (0.13%) and device closure (0.093%, P = .649). Rescue operation for device adverse events (0.83%) was 2.1 times more likely than reoperation for surgical closure (0.39%, P = .063). Mortality per adverse event was higher for device closure (7.6%) than for surgical closure (1.2%, P = .004), and the need for surgery per adverse event was higher for device closure (68.2%) than for surgical closure (3.6%, P < .001). The mortality for surgical management of a device adverse event (2.6%) was 20-fold higher than for primary elective atrial septal defect closure (0.13%, P < .0001).ConclusionOverall crude mortality for device and surgical closure atrial septal defect closure is equivalent, and the need for subsequent operation (surgical rescue) is more common in patients undergoing device closure than reoperation is in patients undergoing surgical closure. Complications from device closure tend to be serious and most often require urgent or emergency operative management, whereas the mortality for surgical management of a device complication appears higher than that of elective atrial septal defect closure. Further information is required in the form of postmarketing surveillance, such as a mandatory user registry with periodic end-user notification

Left ventricular inflow obstruction associated with persistent left superior vena cava and dilated coronary sinus

AbstractBackgroundIt has previously been suggested that significant dilatation of the coronary sinus can contribute to left ventricular inflow obstruction and is amenable to surgical correction. The purpose of this study was to review our experience with this rare condition.MethodsSince 1995, 6 patients have undergone coronary sinus reduction for concerns of obstruction with other concomitant intracardiac repairs. Preoperative echocardiography identified a significantly dilated left superior vena cava to the coronary sinus in 5 patients (83%) and an abnormal mitral valve in 4 patients (67%); these resulted in abnormal Doppler inflow patterns. Preoperative cardiac catheterization was performed in 5 patients and revealed increased atrial “a” waves, with a gradient to the left ventricular end-diastolic pressure in each case. At the time of surgery, coronary sinus angioplasty was performed in all patients.ResultsThere were no deaths, and there was no major morbidity. Follow-up imaging revealed no significant left ventricular inflow obstruction in any patient.ConclusionsWe conclude that dilatation of the coronary sinus can become hemodynamically significant and that coronary sinus angioplasty is a safe and effective technique

Lessons learned from the first application of the DeBakey VAD Child: An intracorporeal ventricular assist device for children

We report and describe the design and the first clinical implantation of the DeBakey ventricular assist device (VAD) Child, a pediatric intracorporeal left ventricular assist device, in a 6-year-old girl. The risk-benefit of novel technologies in advanced heart failure and the lessons learned by our experience are important to consider in hopes that other centers (where this device is now available) may benefit