BACKGROUND: Covered stent correction for a sinus venosus atrial septal defect (SVASD) was first performed in 2009. This innovative approach was initially viewed as experimental and was reserved for highly selected patients with unusual anatomic variants. In 2016, increasing numbers of procedures began to be performed, and in several centers, it is now offered as a standard of care option alongside surgical repair. However, covered stent correction for SVASD is not recognized by regulatory authorities, and in the minds of many pediatric and adult congenital cardiologists and surgeons, the condition is viewed as treatable only by cardiac surgery with cardiopulmonary bypass. METHODS: In April 2023, all centers identified from international conferences, publications, and colleague networks to be undertaking covered stent correction for SVASD were invited to participate in a retrospective audit of their procedures. RESULTS: Data were received on 381 patients from 54 units over a 12-year period with 90% of procedures being performed over the past 5 years. Balloon-expandable stents (8 types) were used in the majority; self-expanding stents (4 types) were used in 4.5%. The commonest stent was the 10-zig covered Cheatham Platinum stent in 62% of cases. In 10 procedures, the stent embolized requiring surgical retrieval and repair of the defect, resulting in technically successful implantation in 371 of 381 (97.4%). Major complications (surgical drainage of tamponade, pacemaker implantation, surgery for pulmonary vein occlusion, and late stent removal) occurred in 5 patients (1.3%). Repeat catheterization to correct residual leaks was required in 7 patients (1.8%). Thus, 359 of 381 patients (94.2%) had successful correction without major complications or additional catheter interventions. CONCLUSIONS: This article details the exponential uptake of covered stent correction for SVASD during the past 5 years. Cardiopulmonary bypass was avoided in the majority of patients, and major complications were infrequent. Prospective registries with standardized definitions, inclusion criteria, and follow-up and comparative studies with surgery are now required to help support the extension of covered stent correction as an alternative standard-of-care option for patients with an SVASD.
24 August 2010 in Catheterization and Cardiovascular Interventions
Purpose: In patients with repaired tetralogy of Fallot, transcatheter or surgical pulmonary valve replacement is recommended. However, it is not clear whether pulmonary valve replacement preserves systolic and diastolic functions of both ventricles. The aim of the study is to investigate the impact of transcatheter pulmonary valve replacement on atrial and ventricular myocardial strain changes by feature-tracking cardiac magnetic resonance imaging. Materials and methods: Cardiac magnetic resonance imaging of 18 patients (median age 14.5 years) with repaired tetralogy of Fallot before and after transcatheter pulmonary valve replacement were retrospectively analyzed. Feature tracking strain for both left and right atria and ventricles was performed. Cardiac magnetic resonance imaging parameters (volume and function) and strain characteristics (atria and ventricles) were compared before and after transcatheter pulmonary valve replacement. The Wilcoxon rank-sum and Spearman correlation test was used. Results: After pulmonary valve replacement, right ventricular end-diastolic volume, end-systolic volume, and stroke volume decreased, whereas left and right ventricular ejection fractions remained unchanged. Reservoir, conduit and pump strain measurements improved for both left (P = 0.003, P = 0.001, and P = 0.006) and right atria (P = 0.013, P = 0.004, and P = 0.015). Global left ventricular circumferential, longitudinal, and radial strains improved (P = 0.001, P = 0.043, and P = 0.002, respectively). Right ventricle global circumferential strain significantly improved with no significant change in the longitudinal and radial strains (P = 0.007, P = 0.068, and P = 0.055, respectively). Conclusion: Transcatheter pulmonary valve replacement significantly enhances atrial and ventricular strain parameters, indicating a positive impact on overall myocardial function. Feature-tracking cardiac magnetic resonance imaging may offer a comprehensive, non-invasive evaluation of myocardial strain changes in patients with repaired tetralogy of Fallot after pulmonary valve replacement, which leads to improvement of indications and outcomes.
1 January 2016 in Turk Kardiyoloji Dernegi Arsivi-Archives of the Turkish Society of Cardiology
Hemolysis after percutaneous device closure of ventricular septal defect (VSD) is a rare complication that can be conservatively managed in the majority of cases. However, surgery or transcatheter occlusion may be necessary. Presently described is the successful treatment of hemolysis that developed after implantation of the Nit-Occlud Lê VSD coil, using the Amplatzer Duct Occluder II (ADO II) in a patient with aneurysmatic perimembranous VSD. Systolic murmur and symptoms immediately disappeared after the procedure.
Background: Although percutaneous closure of patent ductus arteriosus is an established safe procedure, protrusion of the device to descending aorta may occur in various degrees during these procedures, especially in small infants. The aim of our study is to evaluate the benefits of balloon-assisted device releasing technique in the era of preventing device protrusion and conditions related to protrusion.Methods: One hundred and fifty-five infants, who underwent patent ductus arteriosus closure with Amplatzer duct occluder I device between January, 2012 and December, 2018, were retrospectively analysed. Balloon-assisted device releasing technique was used in 20 cases (group 1, 12.9%), between January, 2015 and December, 2018. Procedures in which the technique had been used were compared with the remaining ones (group 2, 87.1%, n = 135) with regard to device stabilisation, aortic disc protrusion to the aorta, iatrogenic coarctation, and device embolisation.Results: There was no significant difference by means of gender, age, weight, and the ductal diameter, whereas the average mean pulmonary artery pressure was significantly higher in group 1. Device protrusion and related complications were significantly higher in group 2; thus, additional catheterisations or surgical interventions were required, while no additional intervention was required in group 1.Conclusion: The balloon-assisted device releasing technique provides a good device stabilisation and prevents protrusion of the device and related complications during percutaneous patent ductus arteriosus closure in selected cases.
18 June 2026 in Circulation: Cardiovascular Interventions
BACKGROUND: Patients with congenital or acquired right ventricular outflow tract dysfunction frequently require pulmonary valve replacement and are exposed to repeated surgical interventions due to prosthetic valve degeneration. The PULSTA self-expanding transcatheter pulmonary valve was designed to address a broad spectrum of native and surgically repaired right ventricular outflow tract anatomies. This study reports the midterm safety, hemodynamic performance, and durability outcomes of the prospective, multinational PULSTA CE approval trial (PULSTA Carpentier Edwards). METHODS: This premarket, multicenter, nonrandomized study enrolled 58 patients across 11 centers in 6 countries. Successful PULSTA implantation was achieved in 57 patients (98.3%), including 4 valve-in-valve procedures. Patients were followed for a median duration of 4.1 years. Primary end points included procedural or device-related serious adverse events, hemodynamic improvement, and sustained valve function. RESULTS: At 6 months, cardiac magnetic resonance imaging demonstrated significant reverse right ventricular remodeling, with marked reductions in right ventricular end-diastolic volume index, end-systolic volume index, and pulmonary regurgitation fraction (all P <0.001). Valve performance remained stable throughout follow-up, with 93.8% of patients exhibiting mild or less pulmonary regurgitation at 4.1 years. Freedom from reintervention was 98.2% at 5 years. One patient required a PULSTA-in-PULSTA implantation due to paravalvular leakage, and one case of infective endocarditis was successfully managed with antibiotic therapy. No stent fractures or structural valve deterioration were observed. CONCLUSIONS: The PULSTA transcatheter pulmonary valve demonstrated high procedural success, durable valve function, and sustained hemodynamic benefits. Its adaptability to diverse right ventricular outflow tract anatomies and favorable safety profile supports its role as an effective therapeutic option for patients with right ventricular outflow tract dysfunction. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03983512.