OBJECTIVES: The CardioSEAL VSD registry was created to track safety of the device to close high-risk Ventricular Septal Defect (VSD). BACKGROUND: This is the first report from the multi-centered CardioSEAL VSD registry reviewing demographics and initial results. METHODS: Centers recruited patients with VSD who were high-risk for surgery due to medical condition or anatomic features. RESULTS: 18 centers contributed data on 55 high-risk patients who had 61 VSD-occlusion procedures, with age of range of 5 days to 65 years and using one to six devices. Implantation approach was transvenous in 48, perventricular in five, and by combined approach in two patients. Ninety-two percent of intended VSD device implants were judged successful. Twenty-two patients had single VSD closed by single device in 18 and by two devices in four patients. All patients <8 kg underwent perventricular device implantation. Thirty-three patients had multiple VSDs which were closed by a single device in 23, and multiple devices in 10. At discharge echocardiography showed total residual flow through all VSDs in which devices were used was classified as "Small" or less in 74%, "More than small" in 11%, and "Uncertain" in 15%. Eight major adverse events occurred in 5/61 cases (8% event rate), with 3/81 devices embolized (4% embolization rate), 5/81 devices surgically explanted (6% explant rate), and no deaths judged to be procedure-related. CONCLUSION: This initial report from the multi-centered CardioSEAL VSD registry demonstrates the safety of the device to close high-risk VSDs. (c) 2007 Wiley-Liss, Inc.
OBJECTIVES: The CardioSEAL VSD registry was created to track safety of the device to close high-risk Ventricular Septal Defect (VSD). BACKGROUND: This is the first report from the multi-centered CardioSEAL VSD registry reviewing demographics and initial results. METHODS: Centers recruited patients with VSD who were high-risk for surgery due to medical condition or anatomic features. RESULTS: 18 centers contributed data on 55 high-risk patients who had 61 VSD-occlusion procedures, with age of range of 5 days to 65 years and using one to six devices. Implantation approach was transvenous in 48, perventricular in five, and by combined approach in two patients. Ninety-two percent of intended VSD device implants were judged successful. Twenty-two patients had single VSD closed by single device in 18 and by two devices in four patients. All patients <8 kg underwent perventricular device implantation. Thirty-three patients had multiple VSDs which were closed by a single device in 23, and multiple devices in 10. At discharge echocardiography showed total residual flow through all VSDs in which devices were used was classified as "Small" or less in 74%, "More than small" in 11%, and "Uncertain" in 15%. Eight major adverse events occurred in 5/61 cases (8% event rate), with 3/81 devices embolized (4% embolization rate), 5/81 devices surgically explanted (6% explant rate), and no deaths judged to be procedure-related. CONCLUSION: This initial report from the multi-centered CardioSEAL VSD registry demonstrates the safety of the device to close high-risk VSDs. (c) 2007 Wiley-Liss, Inc.