Transcatheter Closure In Patients Research Articles

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects.

BackgroundThe last decades have brought remarkable improvements in treatment strategy and occluder modification of secundum atrial septal defect (ASD) closure. Approval, efficacy and safety of ASD closure devices have previously been demonstrated. This study investigated the clinical efficacy and safety of the LifeTech CeraFlexTM ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU).MethodsProcedure specific data was collected on patients considered for ASD closure with the CeraFlexTM occluder between April 2016 and December 2019 in three German centers. Efficacy and safety were assessed after device closure, at discharge, and at 6-month FU.ResultsThe primary endpoint (successful ASD closure without severe complications) was reached by 102/103 patients (99%). Device embolization occurred in two patients (one early and one late embolization). After early snare-retrieval of an embolized device, this ASD was closed surgically and in the other patient with late device embolization the defect was closed with a larger CeraFlexTM occluder. The secondary endpoint (clincal efficacy after 6 months) was reached by 94/98 patients since new onset of arrhythmia occurred in four patients. Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder. Incomplete right bundle branch block (iRBBB) was seen in 31 patients. At last FU only 17 patients had remaining iRBBB documenting effective volume unloading of the right ventricle.ConclusionsCatheter interventional closure of secundum ASDs with the CeraFlexTM ASD occluder was feasible, safe and effective in this study.

Percutaneous Patent Foramen Ovale Closure in a Patient With Anomalous Aortic Origin of the Left Coronary Artery

Percutaneous Patent Foramen Ovale Closure in a Patient With Anomalous Aortic Origin of the Left Coronary Artery

The Outcomes of Transcatheter Closure in Patients with Patent Ductus Arteriosus at Haji Adam Malik General Hospital, Indonesia

BACKGROUND: Patent ductus arteriosus (PDA) is one of the most common acyanotic congenital heart diseases. The incidence of PDA is approximately 1 in 500 full-term neonates. The current management of PDA includes pharmacological and surgical treatments. Transcatheter closure is a preferable PDA treatment than pharmacological intervention, for medications have a higher failure rate in premature infants. Several studies have reported the efficacy and safety of transcatheter closure in smaller and lower-weight infants. AIM: This study aims to describe the outcomes of transcatheter closure of PDA, which are complete closure, migrating device, and residuals, while also investigating factors that might affect these outcomes. METHODS: A descriptive cross-sectional study was conducted from January to March 2018 in the pediatric cardiology outpatient clinic of Haji Adam Malik Hospital, Medan, Indonesia. All PDA patients who underwent transcatheter closure were included in this study. We collected patients’ demographic data (age and sex), PDA size (categorize into large, moderate, and small), and PDA closure outcomes from medical records. The collected data were then analyzed with SPSS. RESULTS: One hundred and two children were included in this study, comprised 34 (33.3%) males and 68 (66.7%) females, with a mean age of 4.3 (±4.02) years old and the mean size of the defects 4.4 (±2.25) mm. Transcatheter closure with Lifetech® PDA Occluder was performed in 95 (93.1%) and MFO® in 7 (6.9%) patients. Small residuals were found in three patients, device migration was found in one patient. No relationship was found between the size of PDA and the outcomes measured. CONCLUSION: We concluded that transcatheter closure remains an effective treatment for PDA, with a considerable success rate.

Feasibility of transcatheter closure for absent aortic rim in patients with atrial septal defect.

This study aimed to assess the feasibility of transcatheter atrial septal defect (ASD) closure in patients with absent aortic rim. The indication of transcatheter closure for ASD with absent aortic rim is controversial. We enrolled 547 patients with ASD who were scheduled for transcatheter closure. Morphologies of aortic rim were evaluated using transesophageal echocardiography (TEE). Aortic rim of <5 mm was observed in 396 (72%) patients; 128 (23%) had absent aortic rim of 0 mm, and 268 (49%) had deficient aortic rim of >0 to <5 mm. Patients with absent aortic rim frequently had aortic rim absence at an angle of 0° on TEE and septal malalignment. Of the 128 patients with absent aortic rim, 126 (98%) successfully underwent transcatheter closure, while 2 (2%) failed transcatheter closure due to a large defect with severe septal malalignment. The success rate of transcatheter closure was similar between patients with absent aortic rim and those with deficient aortic rim (98% vs. 99%, p = .45). After the procedure, no patients had erosion or device embolization during a median follow-up of 24 months. Transcatheter closure was successfully performed without adverse events in patients with absent aortic rim, as well as in those with deficient aortic rim. Our findings can be valuable to determine the indication of transcatheter closure in patients with ASD.

Early changes in ambulatory electrocardiography after transcatheter closure in patients with atrial septal defect and factors affecting heart rate variability

BackgroundFactors affecting heart rate variability (HRV) in patients with atrial septal defect (ASD) have not been clarified. This study sought to identify those factors and establish a preliminary risk model.MethodsA total of 154 patients with ASD who underwent transcatheter closure and met the study requirements were analyzed in this study. Moreover, 26 patients with patent foramen ovale (PFO) were enrolled in our study as a control group. All patients underwent echocardiography and ambulatory electrocardiography before and one day after the procedure.ResultsThe standard deviation of all normal-to-normal (NN) intervals (SDNN) and the standard deviation of the averages of the NN intervals in all 5 min segments of the entire recording (SDANN) were significantly higher and the heart rate was lower after closure than before closure in patients with ASD (SDNN: 6.08, 95% CI 3.00 to 9.15, p < 0.001; SDANN: 7.57, 95% CI 4.50 to 10.64, p < 0.001; heart rate: -1.17, 95% CI − 2.86 to − 0.48, p = 0.006). Multiple regression analyses indicated that age, sex, defect diameter, heart rate and diabetes were significantly associated with HRV indices (SDNN: R2 = 0.415; P < 0.001). SDNN and SDANN had obvious correlations with right ventricular systolic pressure (SDNN: R = − 0.370, p < 0.001; SDANN: R = − 0.360, p < 0.001).ConclusionsFactors affecting HRV in patients with ASD include age, sex, heart rate, defect size and diabetes. Furthermore, right ventricular systolic pressure plays an important role in the change in HRV.

Transcatheter closure of atrial septal defects improves cardiac remodeling and function of adult patients with permanent atrial fibrillation.

Background:Permanent atrial fibrillation (AF) is the most common form of dysrhythmia associated with atrial septal defects (ASDs) in patients older than 40 years. However, little is known about cardiac remodeling after transcatheter closure in patients with permanent AF. This study was designed to compare cardiac events and remodeling effects after transcatheter closure in such patients.Methods:Clinical data of 289 adult patients older than 40 years who underwent ASD closure at our center were analyzed retrospectively. Of them, 63 patients with permanent AF were assigned to the case group, and the other 226 patients without permanent AF were assigned to the control group. Cardiac events and changes in left and right cardiac cavity dimensions before the procedure and 6 months after the procedure were compared between the two groups.Results:Patients in the case group were significantly older than those in the control group. The right ventricular (RV) volume and right atrial (RA) volume were decreased significantly in both the groups during a median follow-up period of 6 months after closure (P < 0.001). The left atrial dimensions, left ventricular end-systolic dimensions, left ventricular end-diastolic dimensions and left ventricular ejection fraction showed no significant change before and after the procedure in both the groups. Changes of the RV volume and RA volume in the case group were significantly smaller than those in the control group (P = 0.005 and P < 0.001). The New York Heart Association cardiac function was improved in both the groups during the 6 months follow-up period.Conclusions:The transcatheter closure of ASD can improve the cardiac remodeling and cardiac function in patients with or without AF.

PP-067 Assesment of Right Ventricular Diastolic Function in Patients Who Underwent Percutaneous ASD Closure Devices

PP-067 T R A C Assesment of Right Ventricular Diastolic Function in Patients Who Underwent Percutaneous ASD Closure Devices. Onder Ozturk, Unal Ozturk. Department of Cardiology, Diyarbakir Gazi Yasargil Education and Research Hospital, Diyarbakir, Turkey; Department of Neurology, Dicle University Medicine Faculty, Diyarbakir, Turkey. T S Objective: The aim of this study was to evaluate right ventricular (RV) diastolic function and its changes after transcatheter closure in patients with ASD using tissue Doppler imaging (TDI). Methods: We prospectively examined 22 consecutive patients who underwent percutaneous transcatheter closure of secundum ASD from

Hjerneinfarkt ved åpent foramen ovale

There is no sound scientific documentation of current guidelines for the treatment of cerebral infarction assumed to be due to patent foramen ovale. In this article, we present a young patient with this condition. In addition, we provide a general overview of the prevalence, recommended assessment and indications for treatment of patent foramen ovale in ischaemic stroke patients. The article is based on a non-systematic search in PubMed. We emphasise three recently published randomised trials on the subject. Transoesophageal echocardiography with saline contrast is the gold standard for detecting patent foramen ovale. Just who will benefit from the diagnosis and treatment of this condition remains unclear, however. None of the three randomised studies of antithrombotic treatment versus transcatheter closure in patients who have suffered ischaemic stroke show a difference in outcomes, but subgroup analyses indicate that closure in young patients (age <50 years) with a large foramen ovale reduces the number of recurrent ischaemic events. Two other randomised studies of antithrombotic treatment alone versus closure are presently ongoing. For stroke patients with patent foramen ovale, the choice between lifelong antithrombotic therapy alone and transcatheter closure is a difficult one. Treatment with antiplatelet agents remains the first choice in most cases. Well-designed studies are needed to identify which patients will benefit most from closure.

GW24-e0510 Assessment Of Right Ventricular Function by Automated Tissue Motion Tracking of Tricuspid Annular Displacement before and after Transcatheter Closure in Patients with Atrial Septal Defect

ObjectivesTo evaluate the change of right ventricular function with tricuspid annular displacement (TAD) measured by tissue motion annular displacement (TMAD) before and after transcatheter closure in patients with atrial septal...

VARIATION OF P-WAVE DISPERSION BEFORE AND AFTER TRANSCATHETER CLOSURE IN PATIENTS WITH ATRIAL SEPTAL ANEURYSM

ObjectivesTo investigate the variation of P-wave dispersion (Pd) before and after transcatheter closure in patients with atrial septal aneurysm (ASA).Methods152 patients with ASA (65 males and 87 females, average age...

Primary Transcatheter Patent Foramen Ovale Closure Is Effective in Improving Migraine in Patients With High-Risk Anatomic and Functional Characteristics for Paradoxical Embolism

In the present study, we sought to assess the effectiveness of migraine treatment by means of primary patent foramen ovale (PFO) transcatheter closure in patients with anatomical and functional characteristics predisposing to paradoxical embolism without previous cerebral ischemia. The exact role for transcatheter closure of PFO in migraine therapy has yet to be elucidated. We enrolled 86 patients (68 female, mean age 40.0 +/- 3.7 years) referred to our center over a 48-month period for a prospective study to evaluate severe, disabling, medication-refractory migraine and documented PFO. The Migraine Disability Assessment Score (MIDAS) was used to assess the incidence and severity of migraine. Criteria for intervention included all of the following: basal shunt and shower/curtain shunt pattern on transcranial Doppler and echocardiography, presence of interatrial septal aneurysm and Eustachian valve, 3 to 4 class MIDAS score, coagulation abnormalities, and medication-refractory migraine with or without aura. On the basis of our inclusion criteria, we enrolled 40 patients (34 females, mean age 35.0 +/- 6.7 years, mean MIDAS 35.8 +/- 4.7) for transcatheter PFO closure; the remainder continued on previous medical therapy. Percutaneous closure was successful in all cases, with no peri-procedural or in-hospital complications. After a mean follow-up of 29.2 +/- 14.8 months (range 6 to 48 months), PFO closure was complete in 95%; all patients (100%) reported improved migraine symptomatology (mean MIDAS score 8.3 +/- 7.8, p < 0.03). Specifically, auras were eliminated in 100% of patients after closure. Primary transcatheter PFO closure resulted in a very significant reduction in migraine in patients satisfying our criteria.

Acute effect of transcatheter closure on right ventricular function in patients with atrial septal defect assessed by tissue Doppler imaging

Objective — Echocardiographic measurement of right ventricular function in patients with atrial septal defect (ASD) is challenging.The Doppler myocardial performance index (MPI) may provide a method of assessing function in these patients. The aim of this study was to evaluate right ventricular function and its changes after transcatheter closure in patients with ASD using MPI by tissue Doppler imaging (TDI).Methods — MPI, defined as the sum of isovolumic relaxation and isovolumic contraction time divided by ejection time, was measured by tissue Doppler imaging and pulsed Doppler (PD), respectively. Measurement of time intervals and MPI with TDI and PD were performed in 46patients with ASD before closure, and at 3days, 1month after closure.Twenty-two healthy volunteers served as control subjects.Results — Both MPI obtained by TDI and PD increased significantly in patients with ASD compared with control subjects (TDI: 0.41±0.07 vs. 0.32±0.04, P<0.001; PD: 0.41±0.07 vs. 0.31±0.04, P<0.001). There were highly significant correlations between MPI values obtained by TDI and by PD in patients with ASD and in control subjects, respectively (r=0.46, P=0.001; r=0.72, P < 0.001, respectively). After transcatheter closure, the MPI obtained by TDI decreased markedly in patients with ASD (3days after closure: 0.37±0.06, P=0.004; 1month after closure: 0.33±0.05, P < 0.001, respectively).Conclusions — The TDI-derived MPI can be used to assess the global right ventricular function in patients with ASD. Compared with control subjects, the MPI was significantly higher in patients with ASD suggesting decreased right ventricular function.After transcatheter closure, the MPI decreased markedly and right ventricular function improved in patients with ASD.

Outcomes in patients with pulmonary hypertension undergoing percutaneous atrial septal defect closure

Objectives:To examine the outcomes in patients with moderate or severe pulmonary arterial hypertension (PAH) undergoing percutaneous atrial septal defect (ASD) closure.Design:Retrospective study.Setting:Teaching hospital-based study.Patients:Fifty-four patients with moderate (n = 34)...

Balloon sizing and transcatheter closure of acute atrial septal defects guided by magnetic resonance fluoroscopy: Assessment and validation in a large animal model

To quantitatively assess atrial septal defects (ASDs) with small shunts using MRI followed by transcatheter closure monitored by MR fluoroscopy. Acute ASDs were created in 14 pigs under x-ray fluoroscopy. Six animals were studied in order to select MR-compatible delivery systems and imaging strategies. ASDs in eight animals were examined with balloon sizing under MR fluoroscopy, flow measurements, and contrast media injections, after which transcatheter closure was performed under MR fluoroscopy. The delivery system was assembled from commercially available materials. The ratio of pulmonary to systemic flow (Qp/Qs) was reduced from 1.23 +/- 0.15 before ASD closure to 1.07 +/- 0.11 after ASD closure (P < 0.001). In two out of eight animals Qp/Qs was close to 1.0 before closure despite the presence of defects >15 mm. The ASDs were measurable with MR balloon sizing in all of the animals. Balloon sizing was identical with MR (16.9 +/- 2.3 mm) and x-ray fluoroscopy (17.1 +/- 1.3 mm). The in-house-assembled delivery system allowed successful placement of closure devices under MR guidance. Assessment and closure of small shunts with MR fluoroscopy is feasible. A barrier to the rapid implementation of transcatheter closure in patients is uncertainty about the MR safety of guidewires and device delivery systems.

Transcatheter closure of various types of defects within the oval fossa using the double umbrella device (CardioSEAL)--feasibility and echocardiographic follow-up.

Data on long-term follow-up for closure of so-called secundum type" atrial septal defects within the oval fossa using recently developed devices are limited, and results focused on presence of residual shunting. The purpose of our study was to report the experience from a single center establishing the effectiveness of transcatheter closure in patients with various types of defect other than those located centrally within the oval fossa. A total of 72 patients was included in this study. On transesophageal echocardiography, the size of the defects varied from 6 to 18 mm, with estimation of the stretched diameter from 11 to 21 mm. The ratio of stretched diameter to the extent of the residual septum ranged from 0.28 to 0.54. Mean follow-up was 30.5+7.4 months, with a range from 13 to 42 months. The rate of closure using devices with diameters from 28 to 40 mm increased from 80% immediately after implantation to 93% in the 57 patients examined 24 months after implantation. For further analysis, we compared the 44 patients with a solitary, centrally located, defect to 28 having morphological variations, including superiorly located defects with deficient superior and aortic rims, multifenestrated and aneurysmal defects, or isolated additional defects. There was no incidence of formation of thrombus, sustained atrial arrhythmia, or infective endocarditis. Residual shunting was not influenced by location or morphology of the defects, but increased with size, stretched diameter, and the ratio of pulmonary to systemic flows. Serial transthoracic echocardiographic findings revealed malposition of one right-sided superior arm of the device in 8 patients, while protrusion of one left-sided arm onto the right atrial aspect was observed in 3 patients. Fluoroscopy showed fatigue fracture of a single arm in 7 patients (9.7%) within the first 6 months after implantation. These results demonstrate that transcatheter closure with the non self-centering double umbrella device was effective and safe on medium-term follow-up, and could be extended to defects within the oval fossa having various morphologies. Residual shunting resolved with time, and was not related to either morphology or the position of the device.