Xueqin Zhang1, Quansheng Xing1, Qin Wu1. 1. Heart Center, Qingdao Women and Children's Hospital, Qingdao University, Qingdao, Shandong, China.
Abstract
BACKGROUND: To compare the treatment outcomes between minimally invasive periventricular device occlusion (MIPDO) and right subaxillary incision surgical repair (RSISR) on perimembranous ventricular septal defect (PmVSD) in children weighing less than 15 kg. METHODS:From January 2010 to January 2013, 538 infants (age < 3 years, weight < 15 kg) with PmVSD were randomly divided into two groups according to different treatment methods. Group 1 (265 cases) had periventricular device occlusion through a lower partial median sternotomy under transesophageal echocardiography (TEE); group 2 (265 cases) underwent surgical repair on cardiopulmonary bypass (CPB) through a right subaxillary incision. A prospective randomized controlled study was performed regarding success rate, operation time, volume of blood loss and transfusion, length of intubation and intensive care unit (ICU) stay, complications, expenses, and follow-up results. RESULTS: All patients had effective treatment with no death or serious life-threatening complications. In group 1, 255 cases (96.23%) underwent successful periventricular device occlusion. The remaining 10 cases (3.77%) were successfully converted to conventional operation. Different arrhythmias arose in 30 cases (11.76%), trivial residual shunt (RS) in 18 cases (7.06%), and new trivial tricuspid regurgitation (TR) in 29 cases (11.37%). In group 2, all patients (100%) underwent successful surgical repair. Different arrhythmias occurred in 116 cases (43.77%), trivial RS in 16 cases (6.04%), new trivial TR in 11 cases (4.15%), and heart dysfunction in 17 patients (6.42%). All patients were followed for more than 12 months. The final treatment effects were similar in both groups, but group 1 was significantly superior to group 2 regarding operation time, volume of blood loss, length of intubation and ICU stay, hospitalizations, and costs (all p < 0.05). TR incidence was higher in group 1 (p < 0.05), and that of right bundle branch block was higher in group 2 (p < 0.05). The incision was longer in group 2, but in a less exposed location. CPB was not needed in group 1, but anticoagulants were required for 3 to 6 months. CONCLUSION: Both RSISR and MIPDO are effective treatment methods for PmVSD. Though having some limitations, MIPDO not only minimized the surgical trauma to patients but also ensured safety to the maximum extent. However, patient selection is vital. For selected patients, especially those with moderate PmVSDs with obvious clinical symptoms and no valve regurgitation, it seems an ideal approach. Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities:
BACKGROUND: To compare the treatment outcomes between minimally invasive periventricular device occlusion (MIPDO) and right subaxillary incision surgical repair (RSISR) on perimembranous ventricular septal defect (PmVSD) in children weighing less than 15 kg. METHODS: From January 2010 to January 2013, 538 infants (age < 3 years, weight < 15 kg) with PmVSD were randomly divided into two groups according to different treatment methods. Group 1 (265 cases) had periventricular device occlusion through a lower partial median sternotomy under transesophageal echocardiography (TEE); group 2 (265 cases) underwent surgical repair on cardiopulmonary bypass (CPB) through a right subaxillary incision. A prospective randomized controlled study was performed regarding success rate, operation time, volume of blood loss and transfusion, length of intubation and intensive care unit (ICU) stay, complications, expenses, and follow-up results. RESULTS: All patients had effective treatment with no death or serious life-threatening complications. In group 1, 255 cases (96.23%) underwent successful periventricular device occlusion. The remaining 10 cases (3.77%) were successfully converted to conventional operation. Different arrhythmias arose in 30 cases (11.76%), trivial residual shunt (RS) in 18 cases (7.06%), and new trivial tricuspid regurgitation (TR) in 29 cases (11.37%). In group 2, all patients (100%) underwent successful surgical repair. Different arrhythmias occurred in 116 cases (43.77%), trivial RS in 16 cases (6.04%), new trivial TR in 11 cases (4.15%), and heart dysfunction in 17 patients (6.42%). All patients were followed for more than 12 months. The final treatment effects were similar in both groups, but group 1 was significantly superior to group 2 regarding operation time, volume of blood loss, length of intubation and ICU stay, hospitalizations, and costs (all p < 0.05). TR incidence was higher in group 1 (p < 0.05), and that of right bundle branch block was higher in group 2 (p < 0.05). The incision was longer in group 2, but in a less exposed location. CPB was not needed in group 1, but anticoagulants were required for 3 to 6 months. CONCLUSION: Both RSISR and MIPDO are effective treatment methods for PmVSD. Though having some limitations, MIPDO not only minimized the surgical trauma to patients but also ensured safety to the maximum extent. However, patient selection is vital. For selected patients, especially those with moderate PmVSDs with obvious clinical symptoms and no valve regurgitation, it seems an ideal approach. Georg Thieme Verlag KG Stuttgart · New York.