Notes: Surgical repair for recurrent or residual postoperative coarctation of the aorta is associated with some morbidity, mortality, and an incidence of recurrent coarctation that may be as high as 20%. Balloon angioplasty for recurrent or residual postoperative coarctation has become the standard treatment of choice for this condition. In this article, we review the protocol we use, and the acute and long-term results of this procedure. Since 1983, over 400 patients have undergone balloon angioplasty for recurrent coarctation with excellent immediate relief of the gradient and improvement in the diameter. On long-term follow-up, the majority of these patients enjoyed a lasting beneficial effect of the balloon angioplasty. We discuss the future use of stems for selected patients who are not amenable or failed, balloon angioplasty of recurrent or residual postoperative coarctation. (J Interven Cardiol 1995;8:509–516)

Notes: The impact of device size choice on closure results was analyzed in 138 (101 females, 37 males; age 0.5–84.0 years) consecutive patients who underwent transcatheter closure of the secundum atrial septal defect (ASD) using the Amplatzer septal occluder (ASO). The balloon stretched diameter (SD) of ASD was 19.5 ± 7.2 mm in 123 patients with single defects, and 20.4 ± 6.6 mm for the largest defects in 15 patients with multiple ASDs. The difference (Δ) between ASO size chosen for closure and the stretched diameter of the defect was calculated and divided into groups: Δ (Δ〈2 mm); B (Δ-2.0 to - 0.1 mm); C(Δ=0); D (Δ 0.1–2.0 mm) and E (Δ〉2 mm). The results demonstrated that immediate and 24-hour complete closure rates were significantly higher in patients in groups C and D (P〈0.001). However, at 6-month follow-up, the complete closure rates were similar in patients of groups A-D, while patients of group E had a lower closure rate of75%. The complication rates were similar in all groups. In conclusion, a choice of a device size identical to or within 2 mm larger than the SD of the defect should be used to maximize the closure rates of ASD using the ASO.

Notes: Using an Amplatzer duct occluder, 106 patients (weight 21 ± 18 kg) underwent an attempt at catheter closure of a persistently patent ductus arteriosus (PDA). Their age ranged from 22 days to 48 years. The PDA measured between 1.2 to 8.1 mm at its narrowest diameter. The device was successfully implanted in 105 patients. The immediate closure rate was 70% and gradually increased to 100% at 1 -month follow-up. There was no clinical evidence of hemolysis and no incidence of device embolization or bacterial arteritis. Doppler evaluation showed no evidence of aortic arch or pulmonary artery obstruction. The device, which is currently undergoing multicenter clinical trial in the United States, is proving to be a safe and effective device for closure of the persistently PDA. (J Interven Cardiol 2001;14:33–36)

Notes: We are reporting the worldwide experience in closing atrial septal defects (ASDs) in children and adults using the Amplatzer Septal Occluder (ASO) as of July 2000. The outcome measures were safety and efficacy with special emphasis on: (1) immediate success of the ASD closure as measured by transesophageal echocardiography (TEE), (2) short- and medium-ten follow-up at 24 hours and 1 and 3 months and long-term follow-up at 1, 2, and 3 years as assessed by transthoracic echocardiography (TTE); and (3) the incidence of complications. In all, 3580 procedures were performed in 3535 patients. In 75 patients, the device was not implanted for variety of reasons: 3460 patients received a single ASO device and 45 received two devices for multiple ASDs. The median age of the patients was 12.1 year, (range, 10 days-88 years, the median weight was 41.0 kg (range, 2.4–137 kg) and the median Qp/Qs ratio was 2 (range, 0.3–10). The median size of ASD by TEE was 14 mm (range, 1–38 mm) and the median stretched diameter was 18 mm (range, 4–44 mm). The median size of device implanted was 18 mm (range, 4–40 mm). The median fluoroscopy time was 17.1 minutes (range, 0.0–194.0 minutes). The immediate success rate including those patients with complete closure, trivial residual shunt, or with small residual shunt was 97.4%. This increased to 99.2% and 100% at 3 months and 3 years, respectively. Minor complications were encountered in 2.8% of procedures, while serious complications occurred in less than 0.3% of the cases. There were no device related deaths. We conclude that the ASO is a safe and effective device for catheter closure of small to large ASDs up to a stretched diameter of 40 mm in children and adults with very high short-, medium, and long-term success rates. (J Interven Cardiol 2001;14:37–44)

Notes: Surgical angioplasty for branch pulmonary arterial stenosis (BPAS) is associated with a low success rate and a high mortality rate. The success rate of balloon angioplasty using low pressure balloon catheters is about 60%. Little data are available on the success rate using high-pressure balloon (HPB) catheters. Therefore, our goal is to report the procedural and mid-term success rates using HPB catheters for the treatment of BPAS and those factors associated with success. 38 patients (25 boys/13 girls) with BPAS underwent at least one attempt (48 procedures) of balloon angioplasty using HPB catheters. Their median age was 1.1 years (range, 0.1–22.1 year), and their median weight was 9.6 kg (range, 3.7–61 kg). Thirty patients (79%) had BPAS following surgical intervention for their cardiac defects (mostly post tetralogy of Fallot), and eight (21%) patients had the BPAS associated with Williams syndrome (2 patients), Alagille syndrome (one patient), unoperated tetralogy of Fallot (one patient), and congenital BPAS (4 patients). Twenty-six procedures involved the left pulmonary artery (LPA), and 22 procedures involved the right pulmonary artery (RPA). The overall acute success rate was 56% (27 of 48 vessels). The mean ± SD of the gradient across the stenotic segment decreased from 37 ± 20 to 23 ± 20 mmHg (P 〈 0.001), and the diameter of the narrowest segment improved from 3.5 ± 1.6 to 5.7 ± 2.5 mm (P 〈 0.001). The median RV/AO pressure ratio decreased from 0.64 to 0.52 (P = 0.009). The median ratio of balloon size to the diameter of the narrowest segment was 2.67 (range, 1.3–7.8). Lesion location (RPA) was associated with higher acute success rate (P = 0.03), but not with mid-term outcome. Acute (P = 0.006) and mid-term (P = 0.04) success were related to balloon diameter to vessel diameter ratio. At mid-term follow-up (median interval 2.5 years), 16 vessels (33%) were widely patent. Complications included perforation of a small branch pulmonary artery in one patient, resulting in hemoptysis with complete recovery. One patient developed pulmonary artery hypertension; two patients developed an aneurysm of the dilated segment; one patient developed femoral vein thrombosis; and one patient had a paradoxical embolus associated with a cerbrovascular accident. There were no procedure-related deaths. We conclude that BPAS is challenging to treat. The use of HPB angioplasty may avoid surgery or the permanence of stem implantation and should be the first intervention for this condition in the pediatric patient. Other interventions should be reserved for refractory stenosis.

Notes: Transcatheter closure of a single secundum atrial septal defect (ASD) is performed routinely using various investigational devices. A 37-year-old patient with two large secundum ASDs underwent successful simultaneous transcatheter closure using an 18-mm and 20-mm Amplatzer™ septal occluder device. At 3-month follow-up, transesophageal color Doppler echocardiography revealed one defect to be completely closed, and the other had trivial residual shunt with significant improvement in symptoms.

Notes: Transesophageal echocardiography (TEE) has been successfully used for guiding transcatheter device closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO). However, the use of TEE for device closure requires general anesthesia. Experience with intracardiac echocardiographic (ICE) guidance to close ASD and PFO is limited. One hundred eleven patients (76 female/35 male) with secundum ASD (82 patients) and PFO (29 patients) associated with a stroke underwent an attempt of transcatheter closure of their defects under ICE guidance using the new AcuNav® catheter. The median age of patients was 40 years (range 2.5–80.7) and the median weight was 66 kg (range 12.7–128 kg). The median two-dimensional size of secundum defects as measured by ICE was 17 mm (range 3–32 mm). The median balloon stretched diameter of the ASDs was 22 mm (range 4–36 mm). Five patients had more than one defect that required placement of two devices to close the defects. The median Qp/QS ratio for patients with secundum ASD was 2.1 (range 1–18). ICE provided adequate views of the defects and surrounding structures and the various stages of device deployment. All patients had successful device placement, including the patients who received simultaneous two devices with immediate complete closure of the defects in 100 patients, whereas four and seven patients had trivial and small residual shunt, respectively. The median fluoroscopy time was 10.2 minutes (range 3.7–38.4 minutes) and the median total procedure time was 60 minutes (range 28–180 minutes). There were no complications related to the use of the AcuNav catheter. We conclude that ICE provided unique images of the atrial communications and facilitated device closure of secundum ASD and PFO in children and adults. We believe ICE should replace TEE as a guiding imaging tool for ASD and PFO device closure, thus eliminating the need for general anesthesia. (J Interven Cardiol 2003;16:51–62)

Notes: Balloon atrial septostomy (BAS) remains an important interventional procedure in the palliation of certain forms of congenital heart disease (CHD), Currently, there are four Food and Drug Administration approved catheters (The Miller catheter, the Rashkind catheter, the Fogarty catheter, and the NuMED septostomy catheter) being used for this procedure. The incidence of complications using these catheters ranges from 0%–11%. The purpose of this article is to discuss the available data using these catheters and to report our own experience using the new NuMED catheter. Sixteen patients with CHD (transposition of the great vessels in 14, hypoplastic left heart in one, and one patient with double outlet right ventricle and mitral atresia) underwent BAS using the new NuMED catheter. Twelve patients were 〈 24-hours old, 3 〈 1-week old, and one patient was 72-days old at the time of the procedure. The mean ± SD weight was 3.4 ± 0.6 kg. The aortic saturation increased from 75%± 19% to 90%± 5% (P = 0.002), and the mean v-wave gradient between the left and right atrium decreased from 5.4 ± 3.7 to 1.6 ± 2.6 mmHg (P 〈 0.001); the mean v-wave gradient decreased from 5.9 ± 3.3 to 1.6 ± 2.6 mmHg (P 〈 0.001), and the mean gradient decreased from 3.9 ± 2.4 to 0.5 ± 1.1 mmHg (P 〈 0.001). The diameter of the atrial communication increased from 2 ± 1.1 to 6.5 ± 1.1 mm (P 〈 0.001). The only complication encountered was an episode of atrial flutter in one patient, which responded to cardioversion. We conclude that BAS using this new catheter is safe and effective.