Re-evaluation of the criteria for asymmetric amplatzer occluders in the closure of perimembranous ventricular septal defects: A case series report.

RATIONALE: To discuss suitable criteria for the application of asymmetric Amplatzer occluders for perimembranous ventricular septal defects (pmVSDs). PATIENTS CONCERNS AND DIAGNOSES: We retrospectively studied 18 children with perimembranous VSDs who underwent attempted asymmetric occluder closure between January 2015 and December 2018 in our center. INTERVENTIONS: Asymmetric Amplatzer occluders were attempted to be placed to all the enrolled patients. We analyzed the diameter of the defects with the receiver operating characteristic curve (ROC) values, the size of the occluders attempted, the presence of aneurysm and the presence of aortic valve prolapse for each patient. Then, for patients who experienced successful device implantation, the therapeutic efficiency was evaluated by follow-up. OUTCOMES: Only 5 out of a total of 18 patients completed successful device implantation. Compared with failed cases, successful cases demonstrated a significantly smaller VSD size (5.46 ±â€Š1.03 mm vs. 8.73 ±â€Š2.33 mm, P = 0.012) and had a low ratio of aortic valvar prolapse (20% vs. 76.92%, P = 0.026). Four out of 5 successful cases involved arrhythmia complications, but the rhythm of the heart recovered after drug treatment. According to the ROC and Youden analyses, the cut-off value of the defect size for successful asymmetric Amplatzer occluder implantation was no larger than 5.7 mm. LESSONS: The application of an asymmetric Amplatzer occluder expands the range of indications for patients with superior localized VSD but is largely limited in cases with aortic valvar prolapse and large VSD sizes. All successful cases recovered from arrhythmia postprocedure.

Periprocedural Outcomes of Fluoroscopy-Guided Patent Foramen Ovale Closure With Selective Use of Intracardiac Echocardiography.

BACKGROUND: Recent randomized trials have confirmed the role of patent foramen ovale (PFO) closure in the secondary prevention of cryptogenic stroke. Guidelines have suggested a central role for intraprocedural imaging using intracardiac echocardiography (ICE). However, this modality may not be required to achieve safe and effective closure. We aimed to examine the periprocedural outcomes of PFO closure retrospectively, using fluoroscopic guidance in patients with cryptogenic stroke, with provisional ICE guidance driven by anatomic and procedural factors. METHODS: A retrospective chart review of consecutive patients who underwent PFO closure in a single centre using the Amplatzer PFO occluder (AGA Medical Corporation, Plymouth, Minnesota) for cryptogenic stroke was conducted. Outcomes analyzed included procedural data, periprocedural complications, length of stay, and factors contributing to the use of intraprocedural imaging. RESULTS: Between 2006 and 2017, 467 patients underwent PFO closure for cryptogenic stroke with the Amplatzer PFO occluder; 381 patients underwent closure with fluoroscopy alone, and 86 with ICE and fluoroscopic guidance. Periprocedural arrhythmic complications occurred in 1.3% in the fluoroscopy group and 1.2% in the ICE group (P = 1.000). Vascular complications occurred in 0.5% in the fluoroscopy group and 2.3% (P = 0.323) in the ICE group. One device embolized requiring surgical intervention. There was no in-hospital mortality or stroke. Same-day discharge occurred in 97.6% of patients. CONCLUSION: Our single-centre experience suggests that PFO closure can be safely conducted under fluoroscopic guidance alone with provisional adjunctive ICE use limited to specific anatomic situations.

Percutaneous Atrial Septal Defect Closure Using the Occlutech Figulla Device in Adults: More than 800 Patient-Years of Follow-Up.

PURPOSE: The Occlutech Figulla occluder has been proven safe and effective at midterm follow-up after percutaneous atrial septal defect (ASD) closure. We describe the safety and efficacy at long-term follow-up in adults. METHODS: All consecutive adult patients that underwent ASD closure between 2008 and 2015 were included. All complications were registered. Residual left-to-right shunt (LRS) was diagnosed using color-Doppler transthoracic echocardiography (TTE). Right-to-left shunting was diagnosed using contrast TTE. Successful closure was defined as no LRS at follow-up. RESULTS: In total, 166 patients (mean age 56.7 ± 16.1 years; 62% female) underwent percutaneous ASD closure using the Occlutech Flex I (70%) or Flex II (30%) device (diameter 24 mm; range 10-40 mm) under general anaesthesia and transoesophageal echocardiographic guidance. Long-term follow-up data were available for 144 patients (87%) with a mean follow-up of 5.9 ± 2.6 years, a total of 814 patient-years. During hospitalization, device embolization occurred in three patients (1.8%) with successful extraction in all. During the long-term follow-up, 15 patients (9.8%) suffered new-onset atrial fibrillation and stroke occurred in 2.1%. There was no residual LRS at 12-month follow-up. No device embolization occurred during the long-term follow-up. CONCLUSION: Percutaneous ASD closure using the Occlutech device appears to be safe at long-term follow-up with a high successful closure rate at one year.

Characteristics of Patent Ductus Arteriosus in Congenital Rubella Syndrome.

This study investigated the characteristics of congenital rubella syndrome (CRS)-associated cardiac complications, particularly patent ductus arteriosus (PDA). We reviewed the medical records of patients with CRS who were admitted to the Children's Hospital 1 in Vietnam between December 2010 and December 2012, and patients with CRS who underwent PDA transcatheter occlusion therapy at the cardiology department between December 2009 and December 2015. We compared the characteristics of PDA treated with transcatheter closure between children with CRS (CRS-PDA) and those without CRS (non-CRS-PDA) who underwent PDA transcatheter closure between July 2014 and December 2015. One-hundred-and-eight children with CRS were enrolled. Cardiac defects (99%), cataracts (72%), and hearing impairment (7%) were detected. Fifty CRS-PDA and 290 non-CRS-PDA patients were examined. CRS-PDA patients had smaller median birthweight (p < 0.001), more frequent pulmonary (p < 0.001) and aortic stenosis (p < 0.001), higher main pulmonary artery pressure, and higher aortic pressure in systole/diastole (p < 0.001 for each) than did non-CRS-PDA patients. The proportion of tubular-type PDA was higher in CRS-PDA patients (16%) than in non-CRS-PDA patients (3%) (p = 0.020). Tubular-type PDA was frequently seen in patients with CRS and accompanied by pulmonary/systemic hypertension and pulmonary/aortic stenosis; in these patients, more cautious device selection is needed for transcatheter PDA closure.

Cocoon devices for transcatheter closure of atrial septal defect and patent ductus arteriosus in children: Single center experience.

Closure of the atrial septal defect (ASD) and patent ductus arteriosus (PDA) are among the most frequent cardiac interventional procedures. This was a prospective study, which started together with the implementation of a national program of pediatric interventional cardiology in Romania. We used Cocoon devices in 83 consecutive cases from 92 implantations for ASD and PDA. 27 cases were ASD closure and 56 cases PDA closure. Regarding the ASD closure, the median age was 8.5 years (range 3-25 years) and median weight 25 kg (range 11.5-63 kg). The mean follow-up was 17.4 ±â€Š6.7 months (range 3-26 months). The mean ASD diameter by transesophageal echocardiography was 15.2 ±â€Š4.1 mm (range 8-26 mm). The mean device diameter used was 17.3 ±â€Š5.6 mm (range 8-32 mm). Regarding the PDA closure, the median age was 36 months (range 4-192 months) and median weight 14 kg (range 5-58 kg). The mean follow-up was 15 ±â€Š8 months (range 3-28 months). The mean PDA minimum diameter was 2.5 ±â€Š0.8 mm. The success implantation rate for both groups was 97.6% (2 cases of withdrawn for ASD and PDA), while the complication rate was 2.3% (including 2 ASD device embolization). In the first 24 hours, the closure rates were 96.3% for ASD, 98.2% for PDA, and 100% at 1-month follow-up for both procedures. On short and intermediate follow-up (3-28 months), no device-related complications were noted.The Cocoon devices are safe for transcatheter closure of both ASD and PDA, and the initial experience with their use in our emerging center is encouraging.

Transcatheter Closure of Atrial Septal Defects: Comparable Experience and Outcomes Between Developing and Developed Countries.

Atrial septal defect (ASD) is one of the most common congenital heart defects. Transcatheter device closure of ASDs is safe and effective with most of the reported data being described from developed countries. To evaluate the short and mid-term results and experience of device closure of ASDs at a tertiary center in a developing country and compare it to that from developed countries. Retrospective study based on data collection from all patients who have undergone transcatheter percutaneous device closure for ASD from January 2005 until December 2017 at the Children's Heart Center at the American University of Beirut, Medical Center, Lebanon. During the study period, a total of 254 cardiac catheterizations were performed for device closure of ASDs. The mean age of the patients was 18 ± 17.9 years with 37% being less than 6 years of age. Females were 54%. Defect size ranged from 7 to 37 mm and device size ranged from 8 to 40 mm. The procedure was executed with a success rate of 96%. Five patients had device embolization (2%); in one patient the device was snared and for the remainder the devices were removed surgically. None of the study patients had thrombus formation, neurological complications, bacterial endocarditis, or cardiac erosions. There was no mortality. Device closure of ASDs at our tertiary center in a developing country has an effective and safe profile with excellent results and low complications rates, which compare favorably to those reported from centers in developed countries.

Incidence and Clinical Impact of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion: A Meta-Analysis.

OBJECTIVES: This study sought to assess the incidence and clinical impact of device related thrombus (DRT) following precautions left atrial appendage occlusion (LAAO). BACKGROUND: Device-related thrombus is a known complication of LAAO. However, data on the incidence of DRT and its impact on outcomes are limited. METHODS: The authors performed a meta-analysis of randomized and observational studies to calculate the pooled incidence of DRT and the pooled odds ratio (OR) of ischemic events in patients with DRT and those without DRT. RESULTS: In the 66 included studies; the incidence of DRT was 351/10, 153 (3.8%, range 0% to 17%, I2 = 56.8). The diagnosis was made in <90, 90 to 365, and >365 days in 42%, 57%, and 1% of patients, respectively. There was no difference in DRT rates between the AMPLATZER (AMPLATZER, AGA Medical Corporation, Golden Valley, Minnesota) and WATCHMAN (WATCHMAN, Boston Scientific Corporation, Marlborough, Massachusetts) devices (3.6% vs. 3.1%, p = 0.24). In a meta-regression, age, gender, heart failure, diabetes, CHA2DS2-VASc score, previous stroke, and post-LAAO antithrombotic regimen did not explain the heterogeneity in the incidence of DRT. The pooled incidence of ischemic events in studies that compared outcomes of patients with and without DRT (32 studies; n = 7,689) was 13.2% (37 of 280) in patients with DRT and 3.8% (285 of 7,399) in those without DRT (OR: 5.27, 95% confidence interval [CI]: 3.66 to 7.59; p < 0.001, I2 = 0). In a sensitivity analysis including randomized trials and prospective multicenter registries, the incidence of DRT was 3.7%, and DRT remained associated with higher rates of ischemic events (13.5% vs. 4.4%, OR: 4.15, 95% CI: 2.77 to 6.22; p < 0.001, I2 = 0). CONCLUSIONS: DRT after LAAO is uncommon (3.8%) but is associated with a 4- to 5-fold increase in ischemic events. Further studies are needed to understand the underlying mechanisms and the optimal surveillance and management of DRT.

Transesophageal echocardiography and fluoroscopy for percutaneous closure of atrial septal defects: A comparative study.

The aim of the study was to compare transesophageal echocardiography (TEE) and fluoroscopy for percutaneous atrial septal defect (ASD) closure.This was a retrospective analysis of children who underwent percutaneous ASD closure. The procedure was guided by TEE without fluoroscopy in 130 patients (TEE group) and by fluoroscopy in 163 patients (fluoroscopy group). Baseline demographic/clinical characteristics were recorded. Patients were followed until hospital discharge. Outcomes were procedure duration, peri/postoperative complications, hospital stay, and costs.The TEE and fluoroscopy groups showed no significant differences in age (71.7 ±â€Š40.7 vs 62.5 ±â€Š38.8 months), male/female ratio (54/76 vs 66/97), weight (22.0 ±â€Š12.0 vs 20.1 ±â€Š9.0 kg), ASD diameter (9.9 ±â€Š4.2 vs 9.3 ±â€Š3.9 cm), distances to the superior vena cava (13.4 ±â€Š4.6 vs 13.3 ±â€Š4.2 cm), inferior vena cava (13.4 ±â€Š4.3 vs 13.9 ±â€Š4.1 cm) and atrial septal roof (12.1 ±â€Š4.0 vs 12.3 ±â€Š3.2 cm), or atrial septal size (38.2 ±â€Š6.2 vs 39.4 ±â€Š26.6 cm); distance to the mitral valve was greater in the TEE group (13.2 ±â€Š4.4 vs 11.3 ±â€Š3.9 cm; P < .001). The TEE and fluoroscopy groups showed no significant differences in occlusion device size (14.3 ±â€Š4.6 vs 13.8 ±â€Š4.0 cm) or sheath size (8.7 ±â€Š1.8 vs 8.7 ±â€Š0.9 cm), but procedure duration was shorter in the TEE group (21.5 ±â€Š14.6 vs 28.6 ±â€Š10.9 minutes; P < .001). Postoperative fever (>38°C) occurred less frequently in the TEE group than in the fluoroscopy group (0.8% vs 9.2%; P < .001); there were no significant differences for the other complications. No patient had postoperative residual shunt, occlusion device shedding/displacement, or pericardial effusion. The TEE group had longer hospital stay (3.2 ±â€Š0.6 vs 2.9 ±â€Š0.6 days; P < .001) and higher procedure cost (29,687 ±â€Š4218 vs 28,530 ±â€Š1668 CNY (China Yuan); P = .002) than the fluoroscopy group.TEE-guided percutaneous ASD closure can be used as an alternative to fluoroscopy-guided procedures and avoids the use of radiation or contrast agents.

Management of post-myocardial infarction ventricular septal defects: A critical assessment.

BACKGROUND: Post-myocardial infarction (MI) ventricular septal defects (PIVSD) are an uncommon but life-threatening complication of acute MI. Although surgical closure has been the standard of care, mortality, and recurrence of VSD remain high even after emergent surgery. Transcatheter VSD closure (TCC) devices have become an alternative or adjunct to surgical closure. METHODS: Online database search was performed for studies that included adults with PIVSD who underwent medical treatment (MT) alone, surgical closure (SC) (early or late), and TCC (early, late, or for post-surgical residual VSD). RESULTS: Twenty-six studies were included with a total of 737 patients who underwent either MT (N = 100), SC (early (n = 167), late (n = 100)), and TCC (early (n = 176), late (n = 115), or post-surgical residual VSD (n = 79)). The 30-day mortality among MT group was 92 ± 6.3%, among SC was 61 ± 22.5% (early 56 ± 23%, late 41 ± 30%), and for all TCC patients was 33 ± 24% (early 54 ± 32.7%, late 16 ± 26%), and TCC for post-surgical residual VSD 11 ± 34.9%. The mortality among overall SC, overall TCC and early TCC groups was significantly lower as compared with the MT (P < 0.001 for all comparisons). The overall mortality among all TCC, and late TCC groups was significantly lower when compared with the late SC (P < 0.0001, P < 0.0001, respectively). CONCLUSION: Closure of PIVSD decreases mortality as compared with MT alone and should be attempted as early as possible after diagnosis. Selection of TCC versus SC should be based on factors including complexity of the defect, availability of closure devices, expertise of the operator, and clinical condition of patient.

Patent foramen ovale closure or medical therapy for secondary prevention of cryptogenic stroke: An update meta-analysis of randomized controlled trials.

BACKGROUND: It was under debate whether cryptogenic stroke patients benefited from patent foramen ovale (PFO) closure. We sought to determine secondary prevention strategy in these patients. METHODS: Scientific databases were searched for randomized controlled trials enrolling cryptogenic stroke patients with PFO who underwent PFO closure or medical therapy. The random-effect model was used to analyze the outcomes. RESULTS: We identified 6 trials enrolling 3630 participants in this meta-analysis. When compared with medical therapy, PFO closure reduced risks of recurrent stroke (risk ratio [RR] 0.52, 95% confidence interval [CI] 0.29-0.93) and composite of stroke and transient ischemic attack (TIA) (RR 0.60, 95% CI 0.46-0.80). And no differences in all-cause death (RR 0.80, 95% CI 0.37-1.72) and cardiovascular death (RR 1.47, 95% CI 0.36-5.94) between 2 groups were observed. The risks of major bleeding (RR 0.96, 95% CI 0.47-1.96) and any serious adverse event (RR 1.03, 95% CI 0.92-1.16) did not differ between 2 groups. Yet, PFO closure increased risk of atrial fibrillation (RR 4.25, 95% CI 2.10-8.60). CONCLUSION: PFO closure, as compared with medical therapy, was associated with decreased risk of recurrent stroke and increased risk of atrial fibrillation in cryptogenic stroke patients with PFO.

Transcatheter Closure of a Huge Ductus Arteriosus in a Severely Ill Neonate.

Hemodynamically significant patent ductus arteriosus (PDA) in preterm infants increases morbidity and mortality. Here we describe a 12-day-old neonate with a huge PDA who developed pulmonary hemorrhage following disseminated intravascular clotting and multiple organ failure. Medical treatment or surgical ligation could not be performed because of the patient's poor condition. Transcatheter closure using a commercially available device (Amplatzer Vascular Plug II) successfully treated the huge PDA without major complications. The Amplatzer Vascular Plug II approach might become a new option for PDA closure in small infants, including those who are critically ill.

Long-term outcomes following percutaneous left atrial appendage closure in patients with atrial fibrillation and contraindications to anticoagulation.

PURPOSE: We aimed to evaluate the late clinical outcomes of percutaneous LAA closure in patients with atrial fibrillation (AF) and contraindication to oral anticoagulation. METHODS: Consecutive AF patients with contraindications to oral anticoagulation who underwent successful LAA closure between December 2008 and March 2013 at four centers were included. RESULTS: A total of 101 patients (median age 76 [IQR 69-80] years, 48% women, mean CHA2DS2-VASc 5 ± 2; HAS-BLED 4 ± 1) were included. Eighty-six (85.1%) patients received an Amplatzer Cardiac Plug/Amulet device and 15 (14.9%) patients a Watchman device. The mean follow-up period was 4 ± 1 years. During 358.6 patient-years of follow-up, 7 (6.9%) patients suffered a major stroke (2 cases per 100 person-years; expected rate: 6.2 cases per 100 person-years), and 20 (19.8%) patients experienced at least one episode of major bleeding (6.4 cases per 100 person-years; expected rate: 9.0 cases per 100 person-years). There were no cases of late adverse events related to the device. A total of 34 (33.7%) patients died during follow-up (9.5 cases per 100 person-years). Older age, male sex, low ejection fraction, and chronic kidney disease were identified as predictive factors of late mortality. CONCLUSIONS: Percutaneous LAA closure is safe and effective in the long term in patients with AF with contraindications to anticoagulation. However, a high long-term mortality rate was observed in this high-risk population. Comprehensive patient assessment prior to undergoing LAA closure should identify patients in whose comorbidities limit their overall prognosis.

Percutaneous Left Atrial Appendage Closure with WATCHMAN™ device: peri-procedural and mid-term outcomes from the TRAPS Registry.

PURPOSE: The WATCHMAN device for Left Atrial Appendage Occlusion (LAAO) has proven to be an effective alternative to oral anticoagulation (OAC) in patients with atrial fibrillation (AF), and has now been adopted in clinical practice. In the present study, we analyzed the safety and efficacy profile of the LAAO procedure at mid-term follow-up. METHODS: The TRAPS Registry is an observational, multicenter registry involving four Italian centers. Consecutive patients who had undergone LAAO with WATCHMAN device were enrolled. Clinical, demographic, and procedural data were collected at the time of implantation, and follow-up data were collected to assess the clinical outcome. RESULTS: A total of 151 patients were included in the Registry from May 2012 to October 2015. Implantation of the device was successful in 150/151 patients, with no or minimal (< 5 mm) leakage as assessed by peri-procedural transesophageal echo. In the remaining patient, early device embolization was reported, with no sequelae. Overall, intra-procedural events were reported in 5 (3.3%) patients. During a median follow-up of 16 months (25th and 75th percentile, 10-25), 5 patients died of any cause. The annual rate of all-cause stroke was 2.2% (95% CI, 0.7-5.1), the rate of transient ischemic attack was 1.3% (95% CI, 0.3-3.8), and that of major bleeding 0.4% (95% CI, 0.01-2.4). CONCLUSIONS: LAAO for stroke prevention was safely and effectively achieved by implantation of the WATCHMAN device in patients with non-valvular AF. Moreover, regardless of the risk profile of the population, we observed low rates of death and thromboembolic and bleeding events over a median follow-up of 16 months. These findings were obtained in an unselected group of consecutive patients who were variably eligible for chronic OAC therapy.

Real-world safety and efficacy of WATCHMAN LAA closure at one year in patients on dual antiplatelet therapy: results of the DAPT subgroup from the EWOLUTION all-comers study.

AIMS: The study aimed to confirm the efficacy and safety of WATCHMAN LAA closure in atrial fibrillation patients unsuitable for oral anticoagulation. METHODS AND RESULTS: The EWOLUTION registry prospectively collects all clinical data on 1,005 European patients implanted with a WATCHMAN device. Following the procedure, 605 patients (60.2%) received dual antiplatelet therapy according to the local standard; DAPT was discontinued in 85% of patients within one year. CHA2DS2-VASc and HAS-BLED scores were 4.61.6 and 2.41.2, respectively. The periprocedural SAE rate was 3.3% (2.0% major adverse cardiac events), mostly resolving without sequelae. Device embolisation or pericardial effusion occurred in one (0.2%) and two (0.3%) patients, respectively. TEE (median 62 days post implant, IQR: 47-97) confirmed effective sealing (no leak >5 mm) in 99.2% of patients. Device thrombus was present in 22 patients (4.0%), one patient developed a stroke. One-year mortality in the DAPT group was 9.6% (N=58) reflecting the advanced age and comorbidities in this population. The ischaemic stroke rate at one year was 1.4% (expected based on CHA2DS2-VASc: 7.5%), none fatal. The major bleeding rate was 2.5%, or 2.1% excluding periprocedural events (expected rate on VKA based on HAS-BLED: 5.1%). CONCLUSIONS: LAA closure with the WATCHMAN device followed by DAPT therapy in a high-risk patient population is safe. At one year, the intervention is associated with a substantial risk reduction regarding ischaemic stroke and major bleeding compared to the expected rate based on CHA2DS2-VASc and HAS-BLED scores.

Patent foramen ovale closure vs. medical therapy for recurrent stroke prevention: Evolution of treatment effect during follow-up.

BACKGROUND: Little is known regarding changes in treatment effect over time associated with patent foramen ovale (PFO) closure among patients with embolic stroke of unknown origin. METHODS: We reconstructed Kaplan-Meier curves for stroke from individual randomized trials comparing PFO closure vs. medical therapy among patients with embolic stroke. Random effects Cox-regression analyses were performed in order to estimate hazard ratios (HRs) with 95% confidence intervals (95%CIs). RESULTS: A total of 2531 patients enrolled across 4 randomized trials were included. PFO closure was associated with a significant reduction in the risk of stroke at longest available follow-up (HR 0.18, 95%CI 0.06 to 0.59, P=0.005). However, recurrent stroke was already significantly reduced among patients randomized to PFO closure at 1-year (HR 0.40, 95%CI 0.20 to 0.80, P=0.010), with the treatment effect remaining consistent (P-for-interaction=0.356) between 1- and 5-year (HR 0.14, 95%CI 0.05 to 0.55, P=0.005) and beyond 5-year (HR 0.20, 95%CI 0.03 to 1.19, P=0.077). CONCLUSIONS: Among patients with embolic stroke of unknown origin, PFO closure reduces the risk of stroke compared with medical therapy, with a significant reduction in recurrences starting already within 1-year after percutaneous PFO closure.

Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter.

BACKGROUND: As new devices come into the market, percutaneous techniques improve and interventionalists become more experienced; percutaneous closure gets more common in preterms. In this study we aimed to compare efficacy and safety of Patent Ductus Arteriosus closure surgically versus transcatheter method in preterms <2kg. Best of our knowledge this study is the first one that compares outcomes of surgery and percutaneous Patent Ductus Arteriosus closure in preterms. METHODS & RESULTS: Between the dates July 1997 to October 2014 in our center Patent Ductus Arteriosus of 26 patients <2kg were closed percutaneously (Group A) and 31 less than 2kg operated (Group B). Weight of patients in percutaneous Patent Ductus Arteriosus closure group was significantly more than the surgery group. Mean gestational age of the patients in Group A was 30±1.8weeks, in group B was 28.6±3.5weeks. In group A; all cases were closed successfully except 4 cases: device embolization in 2, cardiac tamponade and iatrogenic aortic coarctation were seen. Pneumomediastinum and chylothorax were the major complications of the surgery group. There was no statistically significance between complication and success rates between two groups. CONCLUSION: Percutaneous Patent Ductus Arteriosus closure is the candidate for taking the place of surgery in preterms. However, it is not applied routinely; can only be done in fully equipped large centers by experienced interventionalists.

Closure of Secundum Atrial Septal Defects With the AMPLATZER Septal Occluder: A Prospective, Multicenter, Post-Approval Study.

BACKGROUND: Prospective data on the medium-term safety and effectiveness of the AMPLATZER Septal Occluder in clinical practice are not available. The objective of this study was to prospectively evaluate the risk of hemodynamic compromise and obtain medium-term survival data on patients implanted with the AMPLATZER Septal Occluder for percutaneous closure of secundum atrial septal defects. METHODS AND RESULTS: Subjects were enrolled prospectively at 50 US sites and followed for 2 years. Between 2008 and 2012, atrial septal defect closure with the AMPLATZER Septal Occluder was attempted in 1000 patients (aged 0.3-83.6 years, mean 21±22 years). Procedural closure occurred in 97.9%, with 1-month and 2-year closure 98.5% and 97.9%, respectively. Hemodynamic compromise occurred in 6 subjects (0.65%), because of dysrhythmia in 2, device embolization in 1, and cardiac erosion in 3. The rate of cardiac erosion was 0.3% (average 83, range 12-171 days from implant). CONCLUSIONS: Closure of atrial septal defect with the AMPLATZER Septal Occluder is safe and effective. The rate of hemodynamic compromise and cardiac erosion is rare. The risk factors for cardiac erosion after device closure are not yet clear. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00650936.

Left atrial appendage closure using AMPLATZER™ devices: A large, multicenter, Italian registry.

BACKGROUND: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding. METHODS: From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset. RESULTS: AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively. CONCLUSIONS: In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism.