Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Safety and efficacy of the Amplatzer™ Trevisio™ intravascular delivery system: Post-approval study results.

BACKGROUND: The Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release. AIMS: To assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect. METHODS: The Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier. RESULTS: The study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged<18years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS. CONCLUSIONS: The Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect.

Assessing the feasibility of using the antecubital vein to perform right heart catheterization in children and adults with congenital heart disease: a retrospective, observational single-center study.

BACKGROUND: Right heart catheterization (RHC) usually is performed via the femoral vein or the internal jugular vein. However, the antecubital fossa vein is a valid venous access, and it has become increasingly popular to perform right heart catheterization utilizing this access. METHODS: A retrospective, observational study was conducted to describe use of the antecubital fossa vein for right heart catheterization in adults and children with congenital heart disease (CHD). Patients who had undergone RHC via antecubital fossa vein at the authors' hospital between September 2019 and December 2022 were included. The outcomes studied were procedural failure and procedure-related adverse events. RESULTS: Fifty-two patients with CHD underwent right cardiac catheterization via an upper arm vein. The upper arm vein was unable to perform the RHC in only 2 patients (3.8%). Only 1 patient developed a minor adverse event. No irreversible and/or life-threating adverse events were detected. CONCLUSIONS: The upper arm veins are safe and effective to perform a RHC in children and adults with CHD. This approach demonstrates a high percentage of technical success, and few mild complications.

Advances in Percutaneous Patent Foramen Ovale Closure: From the Procedure to the Echocardiographic Guidance.

Percutaneous patent foramen ovale (PFO) closure by traditional, double disc occluder devices was shown to be safe for patients with PFO, and more effective than prolonged medical therapy in preventing recurrent thromboembolic events. The novel suture-mediated "deviceless" PFO closure system overcomes most of the risks and limitations associated with the traditional PFO occluders, appearing to be feasible in most interatrial septum anatomies, even if data about its long-term effectiveness and safety are still lacking. The aim of the present review was to provide to the reader the state of the art about the traditional and newer techniques of PFO closure, focusing both on the procedural aspects and on the pivotal role of transesophageal echocardiography (TEE) in patient's selection, peri-procedural guidance, and post-interventional follow-up.

Impact of pregnancy on natural history of systemic right ventricle in women with transposition of the great arteries.

In the recent years, the pregnancy trend among women with Congenital Heart Disease (CHD) has increased; this has leaded to a growing demand for specialized care both in mother and in children. Although pregnancy is often well tolerated, maternal CHD may affect in some cases a maladaptive hemodynamic response carrying additional risks of cardiovascular events like arrhythmias, heart failure and, in rare cases, death. The impaired utero-placental perfusion due to maternal cardiac status may result in placental dysfunction, which may be associated with fetal growth restriction, preeclampsia, premature birth and perinatal morbidity. Systemic Right Ventricle (SRV) is one of the main conditions under which pregnancy is challenging. The sub-aortic position of morphological Right Ventricle (RV) is "physiologically" predisposed to fail at the adult age and may be potentially inadequate to support the hemodynamic stress of the pregnancy. Current literature about pregnancy in women with SRV consists of small retrospective series not providing conclusive evidence about the feasibility of a successful pregnancy outcomes. In addition, the long-term effects of pregnancy on SVR are not still adequately investigated and it remains unclear if maternal complications reported are due to pregnancy or to natural history of SVR. The aim of this paper is to offer a critical review of the knowledges at regard and to provide a practice update on the risk assessment and the pregnancy management in women with SRV in order to support the decision making and to optimize outcomes in these patients.

Novel echocardiographic score to predict duct-dependency after percutaneous relief of critical pulmonary valve stenosis/atresia.

OBJECTIVES: This study aimed to identify clinical, hemodynamic, or echocardiographic predictive features of persistent duct-dependency of pulmonary circulation (PDDPC) after effective percutaneous relief of pulmonary atresia with the intact ventricular septum (PA-IVS) or critical pulmonary stenosis (CPS). METHODS: From 2010 to 2021, 55 neonates with PA-IVS or CPS underwent percutaneous right ventricle (RV) decompression at our Institution. After successfully relief of critical obstruction, 27 patients (group I) showed PDDPC, whereas RV was able to support the pulmonary circulation in the remaining 28 patients (group II). Clinical, hemodynamic, and echocardiographic features of these two groups were compared. RESULTS: No significant difference in clinical and hemodynamic data was found between the groups, although the group I had a lower oxygen saturation at hospital admission. However, tricuspid valve (TV) diameter <8.8 mm, TV z-score ←2.12, tricuspid/mitral valve annular ratio <.78, pulmonary valve diameter <6.7 mm, pulmonary valve z-score ←1.17, end-diastolic RV area <1.35 cm2 , end-systolic right atrium area >2.45 cm2 , percentage amount of interatrial right-to-left shunt >69.5%, moderate/severe tricuspid regurgitation, RV systolic pressure >42.5 mmHg, tricuspid E/E' ratio >6.6 showed each significant predictive value of PDDPC. These parameters were used to build a composite echocardiographic score (PDDPC-score), assigning one point each above the respective cut-off value. A score ≥4.00 showed high sensitivity (100%) and specificity (86%) in predicting PDDPC. CONCLUSION: Clinical and hemodynamic features fail to predict the short-term fate of the pulmonary circulation after successful treatment of PA-IVS/CPS. However, a simple, composite echocardiographic score is useful to predict PDDPC and could be crucial in the management of this frail subset of patients.

Transcatheter closure of fenestrated atrial septal aneurysm in children: Feasibility and long-term results.

BACKGROUND: To date, extensive experience in transcatheter closure of fenestrated atrial septal aneurysm (ASA) in the pediatric population is limited. METHODS: To report on procedural feasibility, efficacy, and long-term outcome, we enrolled all children submitted to an attempt of transcatheter closure of fenestrated ASA at two, large volume, pediatric cardiology units (Naples and Massa, Italy) between April 2000 to May 2020. RESULTS: This retrospective study included 139 patients (median age 9 years [range 2-18] and weight 36 kg [range 10-102]); 19 (13.7%) children were ≤20 kg (range 10-20) and 14 (10.1%) were ≤5 years old. Single perforation was observed in 28 patients (20.1%), while 111 patients (79.9%) had multifenestrated ASA. The median size of the main defect was 15 mm (range 6-34) and 25 patients (18%) had a defect ≥20 mm. The procedural success rate was 99% (95% confidence interval [CI]: 94.9-99.8) using a single device in 75 (69%), two devices in 31 (28%), and three devices in 3 (3%) cases. Early minor adverse events (AEs) occurred in four patients (2.8%). Late minor AEs were recorded in one patient (0.7%) over a median follow-up of 5 years ([range 0-18 years; total 890.2 person-years, and with 30 patients (22%) followed ≥10 years). Neither mortality nor major AEs were recorded. Freedom from AEs was 99.1% at 10-15 years (95% CI: 93.5-99.8%), without any difference according to atrial septum anatomy or patient age and weight. CONCLUSION: Transcatheter closure of fenestrated ASA is technically feasible and effective in children with excellent long-term outcomes.

Fluid challenge and balloon occlusion testing in patients with atrial septal defects.

INTRODUCTION: Careful, stepwise assessment is required in all patients with atrial septal defect (ASD) to exclude pulmonary vascular or left ventricular (LV) disease. Fluid challenge and balloon occlusion may unmask LV disease and post-capillary pulmonary hypertension, but their role in the evaluation of patients with 'operable' ASDs is not well established. METHODS: We conducted a prospective study in three Italian specialist centres between 2018 and 2020. Patients selected for percutaneous ASD closure underwent assessment at baseline and after fluid challenge, balloon occlusion and both. RESULTS: Fifty patients (46 (38.2, 57.8) years, 72% female) were included. All had a shunt fraction >1.5, pulmonary vascular resistance (PVR) <5 Wood Units (WU) and pulmonary arterial wedge pressure (PAWP) <15 mm Hg. Individuals with a PVR ≥2 WU at baseline (higher PVR group) were older, more symptomatic, with a higher baseline systemic vascular resistance (SVR) than the lower PVR group (all p<0.0001). Individuals with a higher PVR experienced smaller increases in pulmonary blood flow following fluid challenge (0.3 (0.1, 0.5) vs 2.0 (1.5, 2.8) L/min, p<0.0001). Balloon occlusion led to a more marked fall in SVR (p<0.0001) and a larger increase in systemic blood flow (p=0.024) in the higher PVR group. No difference was observed in PAWP following fluid challenge and/or balloon occlusion between groups; four (8%) patients reached a PAWP ≥18 mm Hg following the addition of fluid challenge to balloon occlusion testing. CONCLUSIONS: In adults with ASD without overt LV disease, even small rises in PVR may have significant implications on cardiovascular haemodynamics. Fluid challenge may provide additional information to balloon occlusion in this setting.

Transcatheter closure of fenestrated atrial septal aneurysm: feasibility and long-term results.

AIM: To report on the feasibility, efficacy and long-term outcome of transcatheter closure of fenestrated Atrial Septal Aneurysm (ASA). METHODS: Between April 2000 and May 2020, 568 patients with fenestrated ASA underwent transcatheter closure at two large-volume Pediatric Cardiology and GUCH Units (Naples and Massa, Italy). Procedural indications were cardiac volume overload in 223 patients (39%) or prophylaxis of paradoxical embolization in 345 patients (61%). Patients' median age and weight were 42 years (range 19-52) and 66 kg (range 54-79), respectively. One-hundred and thirty-nine patients (25%) were younger than 18 years. RESULTS: Single fenestration was found in 311 patients (55%) (Group 1), whereas 257 patients (45%) had multifenestrated ASA (Group 2). The procedure was successful in all but seven patients (1.2%). In Group 1, closure was achieved with a single device. In Group 2, one device was used in 168 patients (67%), two devices in 74 patients (28%), three devices in 12 patients (5%), and four devices in 1 patient (0.3%). The early complication rate was 3%, without any difference according to anatomy or patient's age. At discharge, complete shunt closure was higher in Group 1 (92% vs. 72%, P < 0.0001), without any difference between groups at the last follow-up evaluation (100% vs. 99%, P = 0.12). Procedural safety was persistent during the long-term follow-up (mean 7.2 ±â€Š5.4, range 0-19 years): freedom from adverse events was 97% at 10-15 years. Seventeen patients (3%) were submitted to reintervention, mostly as prophylaxis of paradoxical embolization. CONCLUSION: Transcatheter closure of perforated ASA is technically feasible in a high percentage of cases, with excellent long-term outcomes.

Left cervical and circumflex aortic arch with aberrant right subclavian artery arising from a Kommerell diverticulum: A rare vascular ring.

We report a rare case of vascular ring due to a left cervical circumflex aortic arch with aberrant right subclavian artery arising from a Kommerell diverticulum. This is a very rare case of vascular ring in a newborn with stridor and stenosis of the left pulmonary artery. A cardiac catheterization and an angio-computed tomography scan were helpful to clarify the diagnosis. The surgical correction was performed with division of the arterial duct, reimplantation of the right subclavian artery, aortic and tracheal suspension, and pulmonary arterial plasty. The patient was asymptomatic at discharge and 1-year follow-up.

Trans-catheter closure of a rare cause of pre-tricuspid left-to-right shunt: A "double" levoatriocardinal vein without left heart obstructive lesions.

The levoatriocardinal vein is a rare vascular anomalous connection between the left atrium and the superior vena cava (or left innominate vein). This defect is usually associated with left heart obstructive lesions, while it is rarely found in an isolated form. In the former case, the anomalous connection causes a pre-tricuspid left-to-right shunt with right-heart volume overload. We describe the first case of "double" homolateral levoatriocardinal vein in a child with signs and symptoms of right-heart failure and pulmonary blood-flow overload. A trans-catheter closure of both vascular connections was performed with two Amplatzer Vascular Plug type II (Abbott, Plymouth, MN, USA). The percutaneous approach proved to be safe and effective, with early improvement in the signs and symptoms of heart failure. .

DATA in BRIEF of: Interventional Cardiac Catheterization in Neonatal Age: Results in a Multi-centre Italian Experience.

A comprehensive description of morbidity and mortality as well as risk factors of interventional cardiac catheterization performed in neonatal age was reported in our paper recently published on the International Journal of Cardiology (IJCA28502; PII: S0167-5273(20)30384-3; DOI: 10.1016/j.ijcard.2020.04.013). Eight Italian high-volume centres of Paediatric Cardiology were involved in this observational, retrospective data collection and analysis. In this dataset, clinical and procedural characteristics of 1423 newborns submitted to 1551 interventional cardiac catheterization procedures were analyzed. Primary outcomes were considered procedure and in-hospital mortality as well as major adverse event and procedural failure rates. Secondary outcomes were considered minor adverse events and need for blood transfusion. Targets of this data analysis were: 1) to evaluate the overall major risk factors of interventional cardiac catheterization; 2) to identify the most hazardous interventional procedures; 3) to assess possible trends of individual procedures as well as their outcome over time; 4) to find possible relationships between the volume activity of any centre and the procedure and follow-up outcome. In particular, this Data in Brief companion paper aims to report the specific statistic highlights of the multivariable analysis (binary logistic regression) used to assess the impact of any potential risk factors on the type of procedure over a short-term follow-up.

Interventional cardiac catheterization in neonatal age: results in a multicentre Italian experience.

BACKGROUND: Despite recent technical advances, interventional cardiac catheterization is still challenging in neonatal age and no specific data concerning early outcome are so far published in literature. METHODS: Neonatal trans-catheter cardiac interventions performed in high-volume Italian referral centers were retrospectively analyzed. Primary outcomes were procedural major adverse events, in-hospital mortality and procedural failure. Secondary outcomes were minor adverse events and need for blood transfusion. RESULTS: From January 2000 to December 2017, 1423 newborns (mean weight 3.0 ± 0.6 kg, range 1.0-5.8; median age 2.0 days) underwent interventional cardiac catheterization. Overall, global procedure adverse event rate and in-hospital mortality were 10.2% and 5.2%, respectively. At multi-variable analysis, primary composite outcome was significantly related to low-weight (<2.5 kg) (p < 0.01) and younger age (≤7 days) (p < 0.01) at the procedure, prematurity (p < 0.01), uni-ventricular physiology (p < 0.01), associated genetic syndromes (p < 0.01) and procedure risk category (p < 0.01). No relationship between volume of activity of any single center and procedure outcome was found. Over time, a trend toward an increased number of procedures and their complexity was recorded. Trans-catheter management of cardiac malformations with critical, duct-dependent pulmonary blood flow by arterial duct stenting or right ventricular outflow tract stenting showed the highest increase. CONCLUSIONS: Interventional cardiac catheterization is relatively safe and feasible in neonatal age. Peri-natal age, low weight, uni-ventricular physiology and genetic syndromes still significantly contribute to procedural morbidity and in-hospital mortality of this approach.

Patent foramen ovale with complex anatomy: Comparison of two different devices (Amplatzer Septal Occluder device and Amplatzer PFO Occluder device 30/35).

BACKGROUND: Patent foramen ovale (PFO) closure after a cryptogenic cerebral ischemic event is a routinely procedure. The most used device is Amplatzer™ PFO Occluder 25 mm, but PFOs with complex anatomy require larger device for closure. We compared Amplatzer™ Septal Occluder (ASO) device versus Amplatzer™ PFO Occluder 30 or 35 mm (A-PFO 30/35) about the safety of procedure and the presence of residual shunt during the follow-up. METHODS: From June 2002 to July 2016, 355 patients (pts) with PFO undergone closure at our institution. Among these ones, 70 pts (19.7%) had a PFO with complex anatomy and a single device with greater diameter was implanted. In these cases, the following devices were used: Gore® Septal Occluder (GSO) in 4 pts; ASO device in 33 pts (group I) and A-PFO 30/35 in 33 pts (group II). Patients treated with GSO device were excluded by our analysis. RESULTS: Comparing group I and group II, there weren't complications during the procedures. Two patients of group II were lost at follow-up. At last follow-up, 1 pt of group I (3%) and 10 pts of group II (32.3%) had a residual shunt (p < 0.01). 7 of 10 pts of group II and the only 1 of group I with residual shunt underwent a complete closure by Amplatzer™ Vascular Plug (AVP) devices. CONCLUSIONS: ASO devices and A-PFO 30/35 devices are both safe to close complex PFO; but A-PFO 30/35 is associated with a more incidence of residual shunt.

Transcatheter Closure of Arterial Duct in Infants < 6 kg: Amplatzer Duct Occluder Type I vs Amplatzer Duct Occluder II Additional Sizes.

Transcatheter closure of arterial duct (AD) remains challenging in low-weight patients and using Amplatzer Duct Occluder devices is still considered off-label in infants < 6 kg. This study aimed to report a large, single-center experience of percutaneous AD closure in infants < 6 kg as well as to compare the most frequently used devices, Amplatzer Duct Occluder type I (ADO I) and Amplatzer Duct Occluder type II Additional Sizes devices (ADO II-AS) (St. Jude Medical Corp, St. Paul, MN, USA). From March 2000 to March 2017, among the 762 patients submitted to percutaneous closure of AD at our Institution, 33 were infants < 6 kg (age 4.8 ± 2.1 months; weight 5.0 ± 0.9 kg). Fourteen patients (45%) underwent ADO I (Group I) and 19 patients ADO II-AS (Group II) device implantation. AD diameter was 2.6 ± 0.8 (range 1.5-4.0) mm resulting in QP/QS of 2.6 ± 0.0.9 (range 1.1-4.5). Successful device deployment was achieved in all patients without procedural morbidity or mortality. Procedural and fluoroscopy times were not significantly different between the groups. However, total X-ray absorbed dose was significantly higher in Group I (121 ± 69 vs 29 ± 16 mGy/cm2, p < 0.01). Immediate, 24 h, and mid-term (46 ± 37 months, median 39) complete occlusion were recorded in 72.7, 90.9, and 97% of patients, respectively without significant difference between the groups. In conclusion, transcatheter closure of AD with Amplatzer Duct Occluder devices is feasible, safe, and effective also in infants less than 6 kg, without significant difference between the most commonly used devices, namely, ADO I and ADO II-AS.

Fate of Duct-Dependent, Discontinuous Pulmonary Arteries After Arterial Duct Stenting.

Significant and balanced PA growth following arterial duct (AD) stenting has already been consistently reported in literature. However, to date, no data are available about the role of this approach as palliation of congenital heart disease with a duct-dependent discontinuous pulmonary artery (dPA). The aim of this study was to evaluate the fate of a dPA of ductal origin following trans-catheter AD stabilization. Angiographic PA evaluation was performed in seven patients submitted to neonatal AD stenting as palliative recruitment of dPA. Five patients showed discontinuity of one PA, while two patients had both PAs served by bilateral ducts. PA growth was evaluated as per the Nakata index, McGoon ratio as well as dPA (n = 9) versus heart-dependent PA (hPA; n = 5) size and z-score changes. AD stabilization was performed using coronary stents dilated to 3.2 ± 0.3 mm (median 3.4), with significant increase of O2 saturation (from 83 ± 11 to 95 ± 5%, p < 0.02). Control angiography was performed 5.1 ± 2.8 months (median 6 months) after duct stenting, showing significant growth of the dPA (from 3.7 ± 1.0 to 7.6 ± 2.7 mm, p < 0.001; z-score from -0.7 ± 1.4 to 1.7 ± 2.2, p < 0.01). A trend toward better growth of the dPA as compared with the hPA was found (117 ± 87 vs. 54 ± 34%, p = NS). The final vessel size was still significantly different between the groups (dPA 7.6 ± 2.7 vs. hPA 11.9 ± 3.4 mm, p = 0.02), although the final z-score value did not significantly differ (dPA 1.7 ± 2.2 vs. hPA 3.8 ± 0.9 mm, p = NS). In conclusion, percutaneous AD stenting is effective in promoting a significant catch-up growth of duct-dependent dPA, being, therefore, advisable as a reliable alternative to surgical palliation.

[Percutaneous treatment of complex post-myocardial infarction ventricular septal defect: case report and literature review]. / Trattamento percutaneo multi-step di un ampio difetto del setto interventricolare post-infartuale: descrizione di un caso clinico e revisione della letteratura.

Post-myocardial infarction (MI) ventricular septal defects (VSD) are a rare but life-threatening complication of acute MI, with very high mortality rates even if timely approached by surgical repair. Transcatheter closure is an attractive alternative to surgery. However, this option is currently deemed challenging and often unsuitable in complex VSD. We report the case of a young woman in poor hemodynamic conditions due to a complex post-MI VSD. A two-step percutaneous VSD closure was successfully performed adopting a patient-tailored approach based on a throughout knowledge of the anatomic and functional picture using both commercially available dedicated and off-label devices.