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Ceraflex septal occluder and the Figulla atrial septal defect occluder have the advantage of a pivoting mechanism and softer device architecture. This study sought to examine the safety and efficacy of these occluders compared to the Amplatzer septal occluder.
This was a retrospective study. Between January, 2013 and April, 2020, patients with at least 6 months of follow-up were included. Early and late-onset outcomes were examined.
Four hundred seven patients (range: 0.17–70.72 years; 53.1% >18 years; male: 29.2%) underwent atrial septal defect occlusion using Amplatzer septal occluder (n = 313), Ceraflex septal occluder (n = 36) and FSO (n = 58). A longer procedure time was observed in the Amplatzer septal occluder group. Early-onset complication rates in Amplatzer septal occluder, Ceraflex septal occluder and Figulla atrial septal defect occluder were 3.83%, 5.56% and 0%. Ten (2.46%) patients developed delayed complications (2.56%, 0% and 1.72% in the Amplatzer septal occluder, Ceraflex septal occluder and Figulla atrial septal defect occluder groups). Device erosion rate was not different between groups. The occlusion rates were comparable among all the devices.
There is no significant difference in safety and efficacies between the novel atrial septal defect occluding devices compared to Amplatzer septal occluder.
KONAR-MultifunctionalTM VSD Occluder (Lifetech, Shenzhen, China) is one of the most recent additions to the armamentarium of device closure interventions offering special features to tackle complex cardiac anatomies. Herein, we report the first use of the KONAR-MFO in an 8.5-year-old female patient (27 kg/129 cm) with stage III palliated univentricular heart to close an acquired post-operative tunnel-like communication (5 mm long × 2.6 mm large) between the right anterior non-coronary aortic sinus and the rudimentary right ventricular cavity. The shunt was diagnosed two and a half years after bulboventricular foramen surgical enlargement. The 5× 3 mm KONAR-MFO was retrogradely implanted under ultrasound and biplane fluoroscopic guidance. Immediate and 12-month follow-up confirmed successful outcomes with complete shunt closure and preserved aortic valve competence.
As part of a quality improvement project beginning in October 2011, our centre introduced changes to reduce radiation exposure during paediatric cardiac catheterisations. This led to significant initial decreases in radiation to patients. Starting in April 2016, we sought to determine whether these initial reductions were sustained.
After a 30-day trial period, we implemented (1) weight-based reductions in preset frame rates for fluoroscopy and angiography, (2) increased use of collimators and safety shields, (3) utilisation of stored fluoroscopy and virtual magnification, and (4) hiring of a devoted radiation technician. We collected patient weight (kg), total fluoroscopy time (min), and procedure radiation dosage (cGy-cm2) for cardiac catheterisations between October, 2011 and September, 2019.
A total of 1889 procedures were evaluated (196 pre-intervention, 303 in the post-intervention time period, and 1400 in the long-term group). Fluoroscopy times (18.3 ± 13.6 pre; 19.8 ± 14.1 post; 17.11 ± 15.06 long-term, p = 0.782) were not significantly different between the three groups. Patient mean radiation dose per kilogram decreased significantly after the initial quality improvement intervention (39.7% reduction, p = 0.039) and was sustained over the long term (p = 0.043). Provider radiation exposure was also significantly decreased from the onset of this project through the long-term period (overall decrease of 73%, p < 0.01) despite several changes in the interventional cardiologists who made up the team over this time period.
Introduction of technical and clinical practice changes can result in a significant reduction in radiation exposure for patients and providers in a paediatric cardiac catheterisation laboratory. These reductions can be maintained over the long term.
Patent ductus arteriosus is the most common cardiac anomaly in our country. In the last few decades, there has been a lot of interest in developing less invasive techniques like video-assisted thoracoscopic clipping; nevertheless, this also has some complications. We present an 8-year-old female, which had been treated with video-assisted thoracoscopic clipping of patent ductus arteriosus. Five years later, she presented with a large aneurysm of the ductus arteriosus extending to the pulmonary trunk and a residual patent ductus arteriosus. A Cardia ASD occluder of 24 mm was placed in the aneurysm, and the residual ductus arteriosus was then closed with an Amplatzer Plug vascular II device of 10 mm, with a good outcome. The development of an aneurysm after video-assisted patent ductus arteriosus closure is apparently a non-reported complication; therefore, there are also no reports for its treatment. That is why we present this case as an option for its resolution.
This study evaluated the effect of music intervention on the anxiety and stress responses of patients who underwent an interventional cardiac catheterisation.
The study design was a pre- and post-test randomised controlled trial that included 94 patients who underwent a transcatheter atrial septal defect closure. Patients were allocated to receive either music intervention (n = 47) or usual care (n = 47) during the interventional cardiac catheterisation. Music intervention effectiveness was examined in terms of anxiety, salivary cortisol level, and heart rate variability.
The average age of participants was 45.40 years (±16.04) in the experimental group and 47.26 years (±13.83) in the control group. Two-thirds (66.0%) of the participants in each group were women. State anxiety (F = 31.42, p < 0.001), anxiety-numerical rating scale (F = 20.08, p < 0.001), salivary cortisol levels (F = 4.98, p = 0.021), and low-frequency component/high-frequency component ratio (F = 17.31, p < 0.001) in the experimental group were significantly reduced compared with those in the control group at the end of the music intervention.
This study provides practical evidence of a reduction in anxiety and stress response from music intervention preceding an interventional cardiac catheterisation, indicating that this intervention should be considered in clinical management.
Anxiety before an invasive intervention is associated in children with persistent psychological disorders. We studied the effect of the transfer to the catheterisation room by an electric toy car on the anxiety of children and their parents before a cardiac catheterisation.
Forty-eight children with a median age of 5.6 years [4.2–7.0] were randomised to either riding on an electric car to go to the catheterisation laboratory or being transported lying supine on a gurney. Anxiety assessments were performed by a physician blinded to group allocation on the day before the procedure (T0) and at anaesthesia induction (T1). The modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF) and visual analogue scale for anxiety (VAS-A) were used in the children and the VAS-A in the parents.
The mYPAS-SF, VAS-A-child, and the VAS-A-parent scores were significantly higher at T1 than at T0 (p < 0.001, p < 0.001, and p = 0.005, respectively). The primary outcome (the median mYPAS-SF score at T1) was not significantly different in the two groups when males and females were combined. At T1, the VAS-A-child score, however, was significantly lower in the intervention than the control group (22 versus 55, p < 0.001). In the boys, the median mYPAS-SF score at T1 was significantly lower in the intervention group (25.0 versus 51.0, p = 0.024). No difference was observed in girls. The VAS-A parent score was lower at T1 in the intervention group (60 versus 87, p = 0.05).
Riding to the catheterisation laboratory on an electric toy car decreased anxiety in boys and decreased parental anxiety.
Anomalous origin of the left coronary artery from the pulmonary artery is an exceedingly rare and potentially fatal congenital coronary anomaly that typically presents early in infancy. We report an unusual case of anomalous origin of the left coronary artery from the pulmonary artery in a 4-year-old child who presented later in life with vague respiratory and gastrointestinal symptoms and was found to have severe global cardiac dysfunction with evidence myocardial ischaemia.
We present the case of a 4-month-old, former 23-week premature baby who underwent patent ductus arteriosus device closure in the cardiac catheterisation lab with an Amplatzer Piccolo™ device at 12 weeks of life. This was complicated by late migration of the device into the aorta resulting in severe obstruction and requiring surgical intervention.
Recurrent laryngeal nerve injury leading to vocal cord paralysis is a known complication of cardiothoracic surgery. Its occurrence during interventional catheterisation procedures has been documented in case reports, but there have been no studies to determine an incidence.
To establish the incidence of left recurrent laryngeal nerve injury leading to vocal cord paralysis after left pulmonary artery stenting, patent ductus arteriosus device closure and the combination of the procedures either consecutively or simultaneously.
Members of the Congenital Cardiovascular Interventional Study Consortium were asked to perform a retrospective analysis to identify cases of recurrent laryngeal nerve injury after the aforementioned procedures. Twelve institutions participated in the analysis. They also contributed the total number of each procedure performed at their respective institutions for statistical purposes.
Of the 1337 patients who underwent left pulmonary artery stent placement, six patients (0.45%) had confirmed vocal cord paralysis. 4001 patients underwent patent ductus arteriosus device closure, and two patients (0.05%) developed left vocal cord paralysis. Patients who underwent both left pulmonary artery stent placement and patent ductus arteriosus device closure had the highest incidence of vocal cord paralysis which occurred in 4 of the 26 patients (15.4%). Overall, 92% of affected patients in our study population had resolution of symptoms.
Recurrent laryngeal nerve injury is a rare complication of left pulmonary artery stent placement or patent ductus arteriosus device closure. However, the incidence is highest in patients undergoing both procedures either consecutively or simultaneously. Additional research is necessary to determine contributing factors that might reduce the risk of recurrent laryngeal nerve injury.
Retrocardiac course of an ectopic right coronary artery is newly described. The alternative (usual) course of an anomalous right coronary from the left sinus of Valsalva is pre-aortic and intramural, with stenosis. In the present exceptional case, there was no stenosis.
Mitral stenosis is the most common valvular heart disease during pregnancy. When severe, it leads to significant maternal and fetal morbidity and mortality. Percutaneous mitral valve balloon commissurotomy can be performed during pregnancy, and the present study aimed to describe the immediate maternal and fetal outcomes after percutaneous mitral valve balloon commissurotomy was done in a cohort of 23 pregnant patients with severe mitral stenosis in Addis Ababa, Ethiopia.
Included in the current study were all pregnant mothers who had severe rheumatic mitral valve stenosis and who underwent percutaneous mitral valve balloon commissurotomy at the Cardiac Center of Ethiopia over 6-year period. Data were collected through chart abstraction using a structured proforma and then analysed using STATA version 13.0.
Median gestational age was 22 weeks and percutaneous mitral valve balloon commissurotomy was successful resulting in a significant increase in the mean mitral valve area of the group from 0.78 ± 0.20 cm2 to 1.89 ± 0.31 cm2 (p < 0.001). The mean mitral valve inflow gradient of the group was 23.95 ± 6.27 mmHg and 6.80 ± 2.44 mmHg, respectively, before and after the percutaneous mitral valve balloon commissurotomy procedure (p < 0.001). Post-procedure, there was no significant increment in mitral valve incompetence. The mean pulmonary artery pressure of the group decreased from 77.68 ± 23.19 mmHg to 42.31 ± 9.95 mmHg (p < 0.001). There was no fetal or maternal death following the procedure. Pregnancy ended at term gestation for 19/23 (82.6%) of the mothers and the mean birth weight of the neonates was 2800 g.
Percutaneous mitral valve balloon commissurotomy procedure can safely be done for severe symptomatic rheumatic mitral stenosis in pregnancy in our setting.
Tricuspid valvulopathy has gained a lot of attention in recent years, especially due to the advances in percutaneous management. CHD can present with primary or secondary malfunction of the tricuspid valve, often not addressed due to high surgical risk after several interventions. We present two cases of adults with complex congenital heart malformations and borderline clinical situations who successfully underwent percutaneous tricuspid replacement.
Neonatal total anomalous pulmonary venous connection has an incidence of about ∼1–2%.1 The clinical presentation of total anomalous pulmonary venous connection in the neonatal period is dependent on the presence or absence of pulmonary venous obstruction, which is usual when the veins connect to the umbilicovitelline system, as in infradiaphragmatic total anomalous pulmonary venous connection. Obstructed total anomalous pulmonary venous connection presents with severe respiratory distress, metabolic acidosis, and cyanosis and requires urgent surgical intervention. However, critically ill neonates with obstructed total anomalous pulmonary venous connection have a higher surgical morbidity and mortality, and pre-operative stabilisation can improve outcomes in them. We present a case of a septic term neonate with obstructed infradiaphragmatic total anomalous pulmonary venous connection who underwent emergency palliative stent placement for immediate relief of pulmonary venous obstruction.
The paediatric post-cardiac catheterisation Wrap (Wrap), an innovative medical safety device, swaddles young paediatric patients in a supine position aiding in immobilisation post-cardiac catheterisation. This pilot study investigated the feasibility and safety of using the Wrap on young paediatric patients during their bed rest period following cardiac catheterisation with femoral access.
Boston Children’s Hospital Cardiac Catheterization Lab.
20 patients, ages 1–5 years and weighing 3–25 kg.
Investigator-developed tools used to collect data included the Demographic and Outcome Measures Data Tool, the Parent/Caregiver Satisfaction, and Provider Ease of Use tools. They measured:
1. The feasibility of using the Wrap
2. Wrap ease of use from the nurse providers’ perspective
3. Parent satisfaction related to the Wrap
4. Frequency of Wrap non-bleeding-related adverse events
5. Frequency of rebleeding at femoral groin access sites
The Wrap was feasible and safe; increased nurse provider satisfaction by allowing visualisation of the groin access sites while minimising the need for hands-on care; and increased parent satisfaction by allowing parents to hold and provide comfort while their child was on bed rest.
Implications for Research:
The Wrap is a safe alternative to the current practice of swaddling with a bath blanket. Further studies are warranted to assess the Wrap’s effectiveness in reducing the incidence of rebleeding events in the post-cardiac catheterisation period and explore clinical use outside of the Cardiac Catheterization Lab.
Severe tricuspid regurgitation in corrected transposition of great arteries is treated with early bioprosthetic replacement to prevent right ventricular failure. When bioprosthesis degenerates, surgery on cardioplegic arrest further complicates right ventricular function. We report the first transcatheter valve-in-valve implantation of tricuspid valve in a systemic right ventricle in corrected transposition describing the modifications due to anatomical differences in these patients.
Although larger stent placement could be effective for pulmonary vein stenosis, stents extrusion tends to occur due to caliber narrowing, small landing area, and the slippery nature. We placed stents with diameter ≧8 mm for four stenotic lesions using the “half-uncovered technique”. All stents were precisely placed and successfully resolved the stenosis. This technique allows us to avoid extrusion and to perform safe and effective dilatation when placing larger stents for pulmonary vein stenosis.
Non-steroidal anti-inflammatory drugs are the conventional treatment for pericarditis. However, some patients will still suffer from persistence pericardial effusion despite exhausting all conventional management options. A 4-year-old girl with idiopathic pericardial effusion who did not respond to 2 months of conventional therapy had complete resolution of effusion within 5 days, with no recurrence after administration of intrapericardial steroids. As far as we know, this is the first published paediatric case who has shown a similar outcome to that seen in adult studies.
The rate of morbidity and mortality related to pulmonary regurgitation and pulmonary stenosis are big concerns after the surgery for CHD. Percutaneous pulmonary valve implantation has been established as a less invasive technique compared to surgery with promising results according to long-term follow-up of the patients. There are only two approved valve options for percutaneous pulmonary valve implantation until now, which are Melody (Medtronic, Minneapolis, Minn, USA) and Sapien (Edwards Lifesciences, Irvine, Ca, USA). Both valves have limitations and do not cover entire patient population. Therefore, the cardiologists need more options to improve outcomes with fewer complications in a such promising area. Herein, we present a case series applying for pulmonary position in conduits and native right ventricular outflow tract of a new transcatheter valve system Myval ® which is designed for transcatheter aortic valve implantation procedures. This is the first patient series in which the use of Myvalv in dysfunctional right ventricular outflow tracts is described, after surgical repair of CHD.
Complete thrombosis of a pulmonary artery interposition graft in an adolescent with complex repaired CHD was treated successfully with a combination of a novel mechanical thrombectomy system, stent implantation, and thrombolysis. This thrombectomy system used a flexible catheter with a built-in mechanism to attenuate blood loss, while providing effective recanalisation of a foreign graft.