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result(s) for
"Heart Septal Defects, Atrial - surgery"
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Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial
2021
Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD).
One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.
At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P < 0.05 vs. baseline). In the trial group, there was no significant difference in the serum nickel level before vs. after device implantation (P > 0.05).
The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.
Journal Article
Comparison of the efficacy and safety of sedation protocols with the use of dexmedetomidine–remifentanil and propofol–remifentanil during percutaneous closure of atrial septal defects: a randomized clinical trial
2022
Background
The study was aimed to compare the efficacy and safety of different sedation protocols of dexmedetomidine–remifentanil and propofol–remifentanil for percutaneous closure of atrial septal defects (ASD) under transthoracic echocardiography (TTE) guidance.
Material and methods
From March 2020 to January 2021, of 114 patients screened, 59 ASD patients scheduled for percutaneous closure under TTE guidance were randomly allocated into the dexmedetomidine–remifentanil (D–R) group (n = 29) and the propofol–remifentanil (P–R) group (n = 30). The incidence of hemodynamic and respiratory adverse events, arterial blood gas analysis, induction and recovery time, pain score, infusion rate of remifentanil, satisfaction of the surgeon and patient, additional sedatives were collected for analysis and comparison.
Results
The induction time was longer in the D–R group than that in the P–R group (17.66 ± 2.65 min vs 11.43 ± 1.48 min; difference, 6.22 min; 95% CI 5.10 to 7.35;
P
< 0.001). No differences were observed in the 2 groups in terms of the additional sedatives, infusion rate of remifentanil, pain score, recovery time (
P
> 0.05). There was no difference between the two groups regarding the incidence of cardiovascular adverse events (6 [20.7%] vs 4 [13.3%]; difference, 7.4%; 95% CI − 11.7 to 26.5%;
P
= 0.506). Respiratory adverse events occurred in 1 patient (3.4%) in the D–R group, and 8 patients (26.7%) in the P–R group (difference, 23.3%; 95% CI 6.2 to 40.5%;
P
= 0.026). The incidence of hypercapnia was significantly lower in the D–R group (4 [13.8%]) than in the P–R group (13 [43.3%]; difference, 29.5%; 95% CI 7.8 to 51.2%;
P
= 0.012).
Conclusions
Except for more rapid the induction time and higher the surgeon satisfaction score in the propofol–remifentanil protocol, the efficacy was similar between two sedation protocols. The hemodynamic stability was comparable, the dexmedetomidine–remifentanil protocol had superior airway security due to fewer hypercapnia and respiratory adverse events.
Journal Article
Catheter ablation of atrial fibrillation in patients with atrial septal defect: long-term follow-up results
by
Salim, Mohamed
,
Bai, Rong
,
Dong, Jian-Zeng
in
Atrial Fibrillation - diagnosis
,
Atrial Fibrillation - prevention & control
,
Atrial Fibrillation - surgery
2015
Introduction
Atrial fibrillation (AF) is commonly found in patients with structural heart disease (SHD), including atrial septal defect (ASD). The feasibility and safety of ablation for AF in patients with unrepaired ASD is seldom reported.
Objectives
This study aims to evaluate and compare the long-term efficacy of AF ablation in patients with and without ASD.
Methods
From January 2008 to December 2012, 18 consecutive patients were identified with medically refractory AF and an unrepaired ASD under catheter ablation. For each ASD patient, four control subjects were matched from our database.
Results
There were no significant differences between groups in terms of age, sex, type of AF, LA diameter, LVIDD, and EF. The mean procedural and fluoroscopy times were not different between the groups (
p
= NS). After a median follow-up of 20 months, the patients in the ASD group had 44.4 % AF recurrence after a single procedure compared with 34.7 % in the control group (
p
= 0.11). The mean LA diameter in non-recurrent patients was smaller than in recurrent patients (
p
= 0.03). In univariate Cox proportional hazards analyses, the factor found to have a significant association with arrhythmia recurrences was left atrial diameter (hazard ratio 1.059, 95 % confidence interval 1.002 to 1.120,
p
= 0.03).
Conclusions
These results indicate that in patients with AF and an ASD amenable to percutaneous closure, a staged approach with radiofrequency ablation of AF preceding closure is a rational strategy.
Journal Article
Atrial septal defects
by
Geva, Tal
,
Wald, Rachel M
,
Martins, Jose D
in
Biological and medical sciences
,
Cardiac arrhythmia
,
Cardiac Catheterization - methods
2014
Atrial septal defects are the third most common type of congenital heart disease. Included in this group of malformations are several types of atrial communications that allow shunting of blood between the systemic and the pulmonary circulations. Most children with isolated atrial septal defects are free of symptoms, but the rates of exercise intolerance, atrial tachyarrhythmias, right ventricular dysfunction, and pulmonary hypertension increase with advancing age and life expectancy is reduced in adults with untreated defects. The risk of development of pulmonary vascular disease, a potentially lethal complication, is higher in female patients and in older adults with untreated defects. Surgical closure is safe and effective and when done before age 25 years is associated with normal life expectancy. Transcatheter closure offers a less invasive alternative for patients with a secundum defect who fulfil anatomical and size criteria. In this Seminar we review the causes, anatomy, pathophysiology, treatment, and outcomes of atrial septal defects in children and adult patients in whom this defect is the primary cardiac anomaly.
Journal Article
Intravenous sildenafil and inhaled nitric oxide: a randomised trial in infants after cardiac surgery
by
Soto, Rodrigo
,
Shekerdemian, Lara S.
,
Penny, Daniel J.
in
Administration, Inhalation
,
Biological and medical sciences
,
Blood Pressure - drug effects
2003
To investigate the acute effects of intravenous sildenafil on haemodynamics and oxygenation, and its interaction with inhaled nitric oxide (iNO) in infants at risk of pulmonary hypertension early after cardiac surgery.
Prospective, randomised trial.
Paediatric intensive care unit of a children's hospital.
Sixteen ventilated infants early after closure of ventricular or atrioventricular septal defects, were randomly assigned to one of two groups. The study was completed in 15 infants.
Studies were commenced within 7 h of separation from bypass. Seven infants received iNO (20 ppm) first, with the addition of intravenous sildenafil (0.35 mg/kg over 20 min) after 20 min. Eight infants received sildenafil first, iNO was added after 20 min. Vascular pressures, cardiac output and a blood gas were recorded at 0, 20 and 40 min.
In infants receiving iNO first, iNO lowered the pulmonary vascular resistance index (PVRI) from 3.45 to 2.95 units (p=0.01); sildenafil further reduced PVRI to 2.45 units p<0.05). In those receiving sildenafil first, PVRI was reduced from 2.84 to 2.35 units (p<0.05) with sildenafil, and fell to 2.15 units (p=0.01) with the addition of iNO. In both groups, sildenafil reduced the systemic blood pressure and systemic vascular resistance (p<0.01) and worsened arterial oxygenation and the alveolar-arterial gradient (p<0.05).
Intravenous sildenafil augmented the pulmonary vasodilator effects of iNO in infants early after cardiac surgery. However, sildenafil produced systemic hypotension and impaired oxygenation, which was not improved by iNO.
Journal Article
Comparison of Functional Tricuspid Regurgitation Following Transcatheter Atrial Septal Defect Closure in Adult Patients With Sinus Rhythm, Post-ablation Sinus Rhythm, and Permanent Atrial Fibrillation
2026
The changes in tricuspid regurgitation (TR) following transcatheter atrial septal defect (ASD) closure, in relation to preprocedural cardiac rhythms, remain unknown. This study aimed to assess sequential changes in TR after ASD closure based on cardiac rhythms. Patients were categorized as sinus rhythm (SR group, n = 89), SR after catheter ablation for atrial fibrillation (ABL group, n = 14), and permanent atrial fibrillation (AF group, n = 12). Echocardiography was performed at baseline, 1 day, 1 month, and 12 months after the procedure. There were significant differences in age (54.5 ± 17.5 years vs 63.9 ± 12.6 years vs 74.3 ± 8.4 years; p < 0.01) and prevalence of moderate ≥ TR at baseline (44.9% vs 78.6% vs 91.7%; p < 0.01) in the SR, ABL, and AF groups, respectively. The SR group showed significant improvement in TR as early as 1-day postclosure, which persisted at 12 months, whereas the ABL and AF groups exhibited no significant improvements in TR at any point postprocedure. Independent predictors of residual moderate ≥ TR at 12 months included being in the ABL or AF groups and having a higher right atrial volume index (RAVI) at baseline. In conclusion, persistent TR may remain after ASD closure, even for patients who achieve SR postablation and those with permanent AF. This persistence may reflect baseline atrial remodeling, as indicated by larger RAVI, beyond volume unloading after ASD closure. These findings highlight the importance of timely therapeutic interventions and careful monitoring for residual TR following ASD closure, especially in patients with a history of AF.
[Display omitted]
Journal Article
The Effects of Perioperative Inhaled Iloprost on Pulmonary Hypertension with Congenital Heart Disease
by
Sung, Ki Won
,
Choi, Deok Young
,
Park, Kook Yang
in
Administration, Inhalation
,
Adolescent
,
Adult
2013
Objectives: The treatment of choice for congenital heart disease (CHD) with pulmonary arterial hypertension (PAH) is still controversial. We assessed the efficacy and safety of perioperative inhaled iloprost therapy in CHD with PAH. Methods: Among 45 patients with a ventricular septal defect and/or an atrial septal defect with PAH, 28 patients were treated with inhaled iloprost before and after surgery. Perioperative clinical parameters and plasma B-type natriuretic peptide (BNP) were evaluated. Results: No statistical difference in the estimated right ventricular systolic pressure (e-RVP), the e-RVP-to-systemic pressure ratio, and preoperative BNP levels between the iloprost group and the control group were found. Among the iloprost group, oxygen saturation was increased significantly after iloprost inhalation therapy (p = 0.0052). The iloprost group was also significantly correlated with less use of inhaled nitric oxide in the immediate postoperative period compared to the control group (p = 0.021). The durations of mechanical ventilation (p = 0.018), ICU stay (p = 0.005), and chest tube use (p = 0.039) were significantly shorter in the iloprost group compared to the control group. The plasma BNP, checked on 7th day of postoperatively, was lower in the iloprost group than in the control group (p = 0.008). Conclusion: Perioperative inhaled iloprost therapy showed the benefit of cardiac functional improvement and early weaning of postoperative supportive care in the management of CHD with PAH.
Journal Article
Sedation for paediatric transcatheter atrial septal defect closure: comparison of two sedation protocols
by
Aksu, Recep
,
Akin, Aynur
,
Bicer, Cihangir
in
Adolescent
,
Anesthesia, Intravenous - methods
,
Anesthetics, Intravenous - administration & dosage
2014
Aim: This study aimed to compare the effects of dexmedetomidine–propofol and ketamine–propofol sedation on haemodynamic stability, immobility, and recovery time in children who underwent transcatheter closure of atrial septal defects. Methods: In all, 46 children scheduled for transcatheter closure of atrial septal defects (n = 46) were included. The dexmedetomidine–propofol group (n = 23) received dexmedetomidine (1 μg/kg) and propofol (1 mg/kg) for induction, followed by dexmedetomidine (0.5 μg/kg/hour) and propofol (100 μg/kg/minute) for maintenance. The ketamine–propofol group (n = 23) received ketamine (1 mg/kg) and propofol (1 mg/kg) for induction, followed by ketamine (1 mg/kg) and propofol (100 μg/kg/minute) for maintenance. Results: In all, 11 patients in the dexmedetomidine group (47.8%) and one patient (4.3%) in the ketamine group demonstrated a decrease ≥20% from the baseline in mean arterial pressure (p = 0.01). Heart rates decreased ≥20% from the baseline value in 10 patients (43.4%) in the dexmedetomidine group and three patients (13%) in the ketamine group (p = 0.047). Heart rate values were observed to be lower in the dexmedetomidine group throughout the procedure after the first 10 minutes. The number of patients requiring additional propofol was higher in the dexmedetomidine group (p = 0.01). The recovery times were similar in the two groups – 15.86 ± 6.50 minutes in the dexmedetomidine group and 19.65 ± 8.19 minutes in the ketamine group; p = 0.09. Conclusion: The ketamine–propofol combination was less likely to induce haemodynamic instability, with no significant change in recovery times, compared with the dexmedetomidine–propofol combination. The ketamine–propofol combination provided good conditions for the intervention.
Journal Article
Thoracoscopic closure of atrial septal defect in perfused beating hearts
2025
Objective
This study aims to characterize the mid and long-term clinical outcomes of 856 atrial septal defect cases that underwent closure using MTCST without the assistance of a robotic system.
Methods
From June 2009 to September 2023, a total of 856 cases at our center underwent selective repair of a secundum-type atrial septal defect using MTCST without Da Vinci robotic assistance. According to whether the operation was performed during an arrested heart or not, patients were divided into arrested heart group (
n
= 110) and beating heart group (
n
= 746). Cardiopulmonary bypass was established peripherally. Three-port incisions in the right chest were conducted first, followed by a pericardiotomy, superior and inferior vena cava snaring, atriotomy, and the closure of atrial septal defect under a thoracoscope. Patients were followed up from 3 months to 12 years postoperatively.
Results
The exclusively MTCST for atrial septal defect closure was successfully performed without any in-hospital mortality in both groups. None of the procedures required an alternative technique for the closure. There were significant learning curves for cardiopulmonary bypass time and operation time. No residual shunt was observed in all patients during the follow-up transthoracic echocardiography at 5-day and 3-month timepoints postoperatively.
Conclusions
This study demonstrates that an exclusively MTCST for atrial septal defect repair is safe, simple, and minimally invasive. Exclusively MTCST is a new desirable alternative beside robotic-assisted atrial septal defect repair.
Journal Article
Transcatheter closure of atrial septal defect in the elderly: a systematic review and meta-analysis
by
Arvanitaki, Alexandra
,
Giannakoulas, George
,
Efthimiadis, Georgios
in
Adult
,
Aged
,
Atrial Fibrillation
2023
ObjectiveDespite the establishment of transcatheter closure as the treatment of choice in adults with secundum atrial septal defects (ASDs), the effectiveness of this approach in the elderly is disputed. This systematic review and meta-analysis aims to explore the impact of transcatheter ASD closure in patients ≥60 years old.MethodsWe systematically searched four major electronic databases (PubMed, CENTRAL (Cochrane Central Register of Controlled Trials), Scopus and Web of Science), ClinicalTrials.gov, article references and grey literature. Primary outcomes were the right ventricular end-diastolic diameter (RVEDD) and the New York Heart Association functional class change, whereas secondary outcomes included systolic pulmonary arterial pressure (sPAP), left ventricular end-diastolic diameter (LVEDD), brain natriuretic peptide (BNP), tricuspid valve regurgitation (TR) change, as well as the rate of atrial arrhythmias and all-cause mortality.ResultsIn total, 18 single-arm cohorts comprising 1184 patients were included. RVEDD was reduced after ASD closure (standardised mean difference (SMD) −0.9, 95% CI −1.2 to −0.7). Elderly patients had 9.5 times higher odds of being asymptomatic after ASD closure (95% CI 5.06 to 17.79). Furthermore, ASD closure improved sPAP (mean difference (MD) −10.8, 95% CI −14.6 to −7), LVEDD (SMD 0.8, 95% CI 0.7 to 1.0), TR severity (OR 0.39, 95% CI 0.25 to 0.60) and BNP (MD −68.3, 95% CI −114.4 to −22.1). There was a neutral effect of ASD closure on atrial arrhythmias.ConclusionsTranscatheter ASD closure is beneficial for the elderly population since it improves functional capacity, biventricular dimensions, pulmonary pressures, TR severity and BNP. However, the incidence of atrial arrhythmias did not change significantly after the intervention.PROSPERO registration numberCRD42022378574.
Journal Article