Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial.

BACKGROUND: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device. METHODS: Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points. RESULTS: A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=-0.14 [95% CI, -3.42 to 3.13]; P<0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% versus 10.0% and 3.9% versus 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% versus 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness end point (2.8% versus 2.8%; difference=0.00 [95% CI, -1.55 to 1.55]; P<0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% versus 7.7%, difference=-2.12 [95% CI, -4.45 to 0.21]; P<0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% versus 12.3%; difference=-0.71 [95% CI, -3.72 to 2.31]; P=0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41-3.66]; P<0.001 for noninferiority; P=0.003 for superiority). CONCLUSIONS: The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02879448.

Percutaneous Device Closure of Congenital Isolated Ventricular Septal Defects: A Single-Center Retrospective Database Study Amongst 412 Cases.

To identify suitable cases and reduce failure/complication rates for percutaneous ventricular septal defect (VSD) closure, we aimed to (1) study causes of device failure and (2) compare outcomes with different VSD types and devices in a high-volume single center with limited resources. Retrospective data of 412 elective percutaneous VSD closure of isolated congenital VSDs between 2003 and 2017 were analyzed. Out of 412, 363 were successfully implanted, in 30 device implantation failed, and in 19 the procedure was abandoned. Outcome was assessed using echocardiography, electrocardiography, and catheterization data (before procedure, immediately after and during follow-up). Logistic regression analyses were performed to assess effects of age, VSD type, and device type and size on procedural outcome. Median [interquartile range] age and body surface area were 6.6 [4.1-10.9] years and 0.7 [0.5-1.0] m2, respectively. Device failure was not associated with age (p = 0.08), type of VSD (p = 0.5), device type (p = 0.2), or device size (p = 0.1). Device failure occurred in 7.6% of patients. As device type is not related to failure rate and device failure and complication risk was not associated with age, it is justifiable to use financially beneficial ductal devices in VSD position and to consider closure of VSD with device in clinically indicated children.

Veno-venous Extracorporeal Membrane Oxygenation for Right Ventricular Failure with Atrial Septostomy After Corrective Repair of Tetralogy of Fallot.

Right ventricular (RV) dysfunction may occur after cardiac surgery and it is not rare after corrective repair of tetralogy of Fallot (TOF). If traditional treatments with volume management, infusion of inotropic agents, and use of pulmonary vasodilators cannot stabilize the patient, extracorporeal membrane oxygenation (ECMO) or a ventricular assist device (VAD) will be considered as the last resort. Here, we report a young infant patient with RV failure after corrective repair of TOF and without closure of an atrial septal defect (ASD), who was rescued by veno-venous (VV) -ECMO.

Optimal combination strategy of left atrial appendage closure plus catheter ablation in a single procedure in patients with nonvalvular atrial fibrillation.

BACKGROUND: The efficacy and safety of combining left atrial appendage closure (LAAC) plus atrial fibrillation (AF) catheter ablation (CA) in a single procedure has been established, but the optimal combination strategy has not been thoroughly elucidated to date. OBJECTIVE: We aimed to investigate the impact of different combination strategies on clinical outcomes. METHODS: Eighty-two consecutive patients with symptomatic AF (mean CHA2 DS2 -VASc score 4.4 ± 1.4, mean HAS-BLED score 3.5 ± 1.0) were enrolled. LAAC with the Watchman device was performed either before (occlusion-first group, N  =  52) or after (ablation-first group, N  =  30) CA. Procedural and clinical data were retrospectively analyzed to evaluate the advantages of each strategy. RESULTS: Complete device occlusions were achieved in 92.3% and 90.0% of patients, respectively (P  =  0.719). Neither acute nor chronic peridevice leak greater than 5 mm was detected. Oral anticoagulants were held in all patients, except two (one in each group) with asymptomatic device-related thrombi. AF-free success rates were comparable between groups with a mean follow-up of 11.2 ± 7.3 months (75.0% vs. 70.0%, log-rank P  =  0.311). The new peridevice leak rate was significantly lower in the occlusion-first group (7.7% vs. 26.7%, P  =  0.019). Multivariate logistic regression demonstrated that the combination strategy was independently associated with the new peridevice leak (P  =  0.025, OR 13.3). CONCLUSIONS: Both occlusion-first and ablation-first strategies were efficacious and safe as combined procedures in patients with nonvalvular AF; however, the occlusion-first strategy was associated with lower new peridevice leak rates at follow-up.

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.

Occlutech® muscular ventricular septal defect device: the first reported human use.

Percutaneous closure of muscular ventricular septal defects has been well described and has not attracted the same controversy or scrutiny as perimembranous defect closure. Therefore, the development of specifically designed devices has been limited. We report the first use of the Occlutech® muscular ventricular septal defect device. Does its design add any significant benefit?

Transcatheter closure of perimembranous ventricular septal defects with the Amplatzer Vascular Plug-II.

OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of the Amplatzer Vascular Plug-II used for the closure of perimembranous ventricular septal defects. BACKGROUND: There are no FDA-approved transcatheter devices for the closure of perimembranous ventricular septal defects. Several studies have reported on the use of various devices either off-label or under clinical trial protocols. However these reports have described significant adverse events including residual shunts, complete heart block, arrhythmia, and new valve regurgitations. Thus far, no study on the Amplatzer Vascular Plug-II has been reported. METHODS: We conducted a 4-year retrospective chart review from August, 2010 to August, 2014, of patients with perimembranous ventricular septal defects associated with ventricular septal aneurysm who underwent transcatheter closure using the Amplatzer Vascular Plug-II. RESULTS: A total of 16 patients underwent Amplatzer Vascular Plug-II transcatheter closure of their perimembranous ventricular septal defects. The median age was 2.56 years (range: 0.5-27.3). Their median weight was 13.0 kg (range: 6.9-71.6). The left ventricular median defect size was 9.3 mm (range: 5.9-14.4). The right ventricular median defect size was 3.6 mm (range: 2.3-5.8). All the patients underwent successful device implantation with 83% of the patients having complete echocardiographic closure at the 1-year follow-up; however, one procedure was complicated by early device embolisation. The device was successfully retrieved and replaced with a larger device. There were no device-related outflow tract obstructions, rhythm abnormalities, or haemolysis. CONCLUSION: Application of the Amplatzer Vascular Plug-II for closure of perimembranous ventricular septal defects appears to be a safe and effective treatment option. Prospective clinical trials and longer follow-up periods are warranted.

Decline in platelet count after percutaneous transcatheter closure of congenital heart disease.

OBJECTIVE: Decline in platelet count (DPC) in patients with congenital heart disease (CHD) undergoing percutaneous transcatheter closure (PTC) has seldom been reported. We sought to investigate the incidence, severity and predictors of DPC among patients with CHD undergoing PTC. METHODS: Patients with CHD undergoing PTC in our department were consecutively included. Platelet count was measured at admission and daily after PTC at least for 5 days. Bleeding events were observed after PTC. RESULTS: Among the whole population (N = 336), 77 (22.9%) patients had no DPC (< 10%), 238 (70.8%) developed minor DPC (10-49%) and 21 (6.3%) acquired severe DPC (> 50%).The mean length of stay in hospital was longer in the severe DPC group than in the no DPC group (4.4 +/- 0.6 vs. 8.4 +/- 4.5 days, P < 0.01). The rate of minor/minimal bleeding was significantly higher in the severe DPC group (42.9%) than in the no DPC (0.0%) and minor DPC (0.8%) groups (both P < 0.01). Multivariate regression revealed that occluder size, residual shunts and CHD types were independent predictors of severe DPC (all P < 0.05).The rate of severe DPC in patent ductus arteriosus (PDA, 12.6%) was higher than in the atrial septal defect (5.2%) or the ventricular septal defect (0.0%) groups (both P < 0.05).The value of DPC was much smaller in the control group (patients undergoing radiofrequency catheter ablation) than in the case group (4.6 +/- 9.7% vs. 22.3 +/- 16.5%, P < 0.001). CONCLUSION: DPC was frequently presented in CHD patients undergoing PTC and associated with increasing minor/minimal bleeding and longer hospital stay. PDA closure with large occluder size and residual shunt, has the highest risk for developing DPC.

Percutaneous closure of paravalvular mitral regurgitation with Vascular Plug III under the guidance of real-time three-dimensional transesophageal echocardiography.

Transcatheter closure of mitral prosthetic paravalvular leak (PVL) has been hampered by technical challenges and the lack of closure devices specifically designed for this purpose. The oblong cross-sectional shape of the Amplatzer Vascular Plug III device (AVP) may be a more appropriate choice to be deployed for mitral PVL's. Real-time three-dimensional transesophageal echocardiography (RT-3D TEE) has emerged as an efficient tool that provides essential information concerning leakage size, location, and shape as well as navigation of catheters and wires. We assessed the feasibility and short, mid, and long-term efficacy of transcatheter mitral PVL closure using AVP-III under the guidance of RT-3D TEE. Three patients with severe symptomatic mitral PVL at high risk for repeat surgery underwent transcatheter leak closure with AVP III. Transfemoral approaches were used under RT-3D TEE guidance. Transcatheter closure of mitral PVLs was performed successfully in 3 patients using 5 devices. The first patient with 2 devices deployed had residual mitral regurgitation resulting in re-operation at the sixth month. The second patient had improved normally with a functioning prosthesis after the deployment of two devices, but had progressively worsening mitral regurgitation for which re-operation at the sixteenth month of follow-up was necessary. The third patient had no residual leak, with normal prosthetic function. At 24 months follow-up, all patients were in satisfactory clinical status. Although RT-3D TEE plays an essential role in guidance of transcatheter closure of mitral PVLs with AVP III, the absence of a specific closure device limits mid and long-term success rates.

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.

A Comparative Study of Perventricular and Percutaneous Device Closure Treatments for Isolated Ventricular Septal Defect: A Chinese Single-Institution Experience.

OBJECTIVES: To compare the advantages and disadvantages of perventricular and percutaneous procedures for treating isolated ventricular septal defect (VSD). METHODS: A total of 572 patients with isolated VSD were selected in our hospital between January 2015 and December 2016. The patients' median age and weight were five years (1-26 years) and 29 kg (9-55 kg), respectively. The median diameter of VSD was 6.0 mm (5-10 mm). Patients were divided into two groups. In group A, perventricular device closure was performed in 427 patients; in group B, 145 patients underwent percutaneous device closure. RESULTS: Four hundred twelve patients in group A and 135 patients in group B underwent successful closure. The total occlusion rate was 98.5% (immediately) and 99.5% (3-month follow-up) in group A, which were not significantly different from those in group B (97.7% and 100%, respectively). Patients in group A had longer intensive care unit (ICU) stay than those in group B, but patients in group B experienced significantly longer operative times than those in group A. The follow-up period ranged from 8 months to 1.5 year (median, 1 year). During the follow-up period, late-onset complete atrioventricular block occurred in two patients. No other serious complications were noted in the remaining patients. CONCLUSION: Both procedures are safe and effective treatments for isolated VSD. The percutaneous procedure has obvious advantages of shorter ICU stay and less trauma than the perventricular procedure. However, the perventricular procedure is simpler to execute, results in a shorter operative time, and avoids X-ray exposure.

Transcatheter closure of patent foramen ovale to prevent stroke recurrence in patients with otherwise unexplained ischaemic stroke: Expert consensus of the French Neurovascular Society and the French Society of Cardiology.

BACKGROUND: Unlike previous randomized clinical trials (RCTs), recent trials and meta-analyses have shown that transcatheter closure of patent foramen ovale (PFO) reduces stroke recurrence risk in young and middle-aged adults with an otherwise unexplained PFO-associated ischaemic stroke. AIM: To produce an expert consensus on the role of transcatheter PFO closure and antithrombotic drugs for secondary stroke prevention in patients with PFO-associated ischaemic stroke. METHODS: Five neurologists and five cardiologists with extensive experience in the relevant field were nominated by the French Neurovascular Society and the French Society of Cardiology to make recommendations based on evidence from RCTs and meta-analyses. RESULTS: The experts recommend that any decision concerning treatment of patients with PFO-associated ischaemic stroke should be taken after neurological and cardiological evaluation, bringing together the necessary neurovascular, echocardiography and interventional cardiology expertise. Transcatheter PFO closure is recommended in patients fulfilling all the following criteria: age 16-60 years; recent (≤6 months) ischaemic stroke; PFO associated with atrial septal aneurysm (>10mm) or with a right-to-left shunt>20 microbubbles or with a diameter≥2mm; PFO felt to be the most likely cause of stroke after thorough aetiological evaluation by a stroke specialist. Long-term oral anticoagulation may be considered in the event of contraindication to or patient refusal of PFO closure, in the absence of a high bleeding risk. After PFO closure, dual anti-platelet therapy with aspirin (75mg/day) and clopidogrel (75mg/day) is recommended for 3 months, followed by monotherapy with aspirin or clopidogrel for≥5 years. CONCLUSIONS: Although a big step forward that will benefit many patients has been taken with recent trials, many questions remain unanswered. Pending results from further studies, decision-making regarding management of patients with PFO-associated ischaemic stroke should be based on a close coordination between neurologists/stroke specialists and cardiologists.

A meta-analysis of transcatheter device closure of perimembranous ventricular septal defect.

BACKGROUND: While transcatheter device closure of ventricular septal defects (VSDs) is gaining popularity, concerns remain about adverse events; particularly heart block in peri-membranous VSDs (pmVSDs). The aim of this study is to ascertain outcomes of transcatheter device closure of pmVSDs through a meta-analysis of current literature. METHODS: A PubMed and Scopus search for studies in English on device closure of pmVSDs published till end-February 2017 was performed. Exclusion criteria included case series already included in multi-centre studies, sample size <5, and VSD acquired following myocardial infarction. Pooled estimates of success and complications was obtained using the random effects model. RESULTS: A total of 54 publications comprising 6762 patients with pmVSDs were included. The mean age of patients ranged from 1.6 to 37.4years. The pooled estimate of successful device implantation is 97.8% (95% CI: 96.8 to 98.6). The most common complication is residual shunt (15.9%; 95% CI: 10.9 to 21.5). Other complications include arrhythmias (10.3%; 95% CI: 8.3 to 12.4) and valvular defects (4.1%; 95% CI: 2.4 to 6.1). The pooled estimate of complete atrioventricular block (cAVB) is 1.1% (95% CI: 0.5 to 1.9). CONCLUSION: Our meta-analysis suggests that device closure of pmVSDs is a safe and effective procedure. The complication of cAVB is low but significant. The risk is expected to further reduce with newer devices which are less stiff with improved profiles. Further studies validating this will be useful in formulating guidelines for device closure of pmVSDs.

Is the new Occlutech duct occluder an appropriate device for transcatheter closure of patent ductus arteriosus?

AIM: To describe our initial experience with the Occlutech Duct Occluder (ODO) for percutaneous closure of patent ductus arteriosus (PDA). METHODS: Retrospective review of patients undergoing transcatheter PDA closure with the ODO in 2 academic centers. RESULTS: From April 2013 to September 2017, 42 patients underwent PDA closure. Median age at implantation was 34 months (range 4 months-68 years) and median weight was 12 kg (range 4.1-57 kg). Ducts were Krichenko type A duct (n = 34), type E (n = 6), and type C (n = 2). The mean duct diameter was 3.76 mm (range 1.69 to 9.95 mm, median 3.1 mm). Implantation succeeded in all. There was neither device embolization nor hemolysis. At device release, immediate angiogram showed a small residual shunt in 54.7%. During follow-up, Doppler echocardiography demonstrated 71% of full occlusion at day one, rising to 95% at one month and 100% at one year and half after implantation. The mean maximal systolic pressure gradient in left pulmonary artery was 4.2 ±â€¯4.3 mm and across the distal aortic arch 5.4 ±â€¯4.7 mm Hg. No patient had any significant stenosis with clinical relevance. CONCLUSIONS: ODO is safe and effective in transcatheter closure of PDA including relatively large sized ducts. The results are satisfactory with a high level of full occlusion and a low rate of complications. Further evaluation with larger studies and longer follow-up will be required to confirm these preliminary good results.

History of Percutaneous Left Atrial Appendage Occlusion with AMPLATZER Devices.

AMPLATZER devices preceded WATCHMAN occluder in 2002 for catheter-based left atrial appendage occlusion. The AMPLATZER technique facilitates simultaneous closure of atrial shunts using two devices through one gear. Randomized WATCHMAN follow-up data showed a mortality benefit over warfarin. AMPLATZER data make this likely valid for the strategy. Particularly young people with atrial fibrillation should be offered left atrial appendage occlusion because the risk is confined to the intervention and early postintervention period. Guidelines should be adapted to make this progress in prevention of stroke and bleeding in patients with atrial fibrillation accessible for all, in the sense of a mechanical vaccination.

Antegrade approach for closure of distal and torturous congenital coronary artery fistula: A case report.

RATIONALE: Coronary artery fistulae (CAF) are uncommon heart lesions, but they are the most frequent significant hemodynamic congenital coronary anomaly. Transcatheter closure is an alternative treatment and a variety of techniques and devices were reported to use for the closure of congenital coronary fistulae. PATIENT CONCERNS: We reported a 5-year-10-month-old boy who was diagnosed as CAF at birth. Follow-up transthoracic echocardiography showed persistent CAF and progressed dilatation of the left coronary artery. DIAGNOSES: Coronary angiography showed torturous coronary vessel and CAF at the distal segment of the left circumflex artery (LCX). INTERVENTION: Antegrade approach with Amplatzer Vascular Plug was used due to the retrograde approach failed and showed a good result. OUTCOMES: During a 3-year follow-up period, the patient showed no symptoms and demonstrated good exercise ability. Follow-up coronary angiography showed the Amplatzer vascular plug was located at an adequate position without a residual shunt from the CAF, and the diameter of the left coronary artery regressed when compared to previous angiography results. LESSONS: The antegrade approach is a feasible method for closing CAF if torturous vessels are noted and fistulae occur at the distal portion of the coronary artery. A large randomized study or case series are needed to investigate the comparison of antegrade and retrograde method for the closure of CAF.

A case of platypnoea orthodeoxia following Laproscopic Cholecystectomy.

Platypnoea Orthodeoxia syndrome is defined by dyspnoea and hypoxaemia exacerbated by orthostatic positioning and alleviated in recumbency. This condition has been reported in association with pulmonary, hepatic and cardiac disease. We describe a case herein of a 79 year old female who developed severe hypoxaemia and dyspnoea post laparoscopic cholecystectomy. A difference in arterial blood gas oxygen tension was demonstrated in the supine and erect positions on arterial blood gas analysis. A Patent Foramen Ovale (PFO) with a right to left shunt was evident on echocardiogram employing colour doppler and agitated normal saline studies. Definitive management, with closure of the patent foramen ovale lead to a complete resolution of symptoms and normalisation of arterial blood gas parameters in both the supine and erect positions.