Treatment of pulmonary arteriovenous malformations: clinical experience using different embolization strategies.

PURPOSE: To evaluate embolization efficacy of pulmonary arteriovenous malformations (PAVM) using Amplatzer vascular plugs (AVP) and coils. MATERIALS AND METHODS: Eighty-eight embolized simple PAVMs in 38 patients were retrospectively analyzed by follow-up CT. Mean age was 50.2 ± 15.6 years and 22 (57.9%) patients were females. Mean follow-up interval was 38.2 ± 28.4 months (median 29.9 months). Embolization devices included AVP I, AVP II, AVP 4, and coils. Technical success was defined as no visualization of an early draining vein at angiography after embolization. Treatment success was defined as complete disappearance or decrease in size of the venous aneurysm ≥ 70% at follow-up CT. RESULTS: Technical success rate was 100% and treatment success rate evaluated by CT for the various embolization strategies was 100% for AVP I (n = 6), 100% for AVP I + coils (n = 5), 83.3% for AVP II (n = 6), 40.0% for AVP II + coils (n = 5), 87.5% for AVP 4 (n = 8), 50.0% for AVP 4 + coils (n = 8), and 78.0% for coils alone (n = 50). No statistically significant difference in embolization efficacy was seen between different devices (P = 0.083). Although not statistically significant, combination use of coils with AVPs demonstrated lower rates of clinical embolization success (P = 0.053). CONCLUSION: Embolization of PAVMs demonstrated high technical and treatment success rates with available embolic devices. No significant statistical differences were demonstrated between AVPs. However, the need for both coils and AVPs may suggest a more complicated underlying lesion at risk for recurrence.

Left Atrial Appendage Closure and Systemic Homeostasis: The LAA HOMEOSTASIS Study.

BACKGROUND: The impact of left atrial appendage (LAA) exclusion, comparing an epicardial LAA or an endocardial LAA device, on systemic homeostasis remains unknown. OBJECTIVES: This study compared the effects of epicardial or endocardial LAA devices on the neurohormonal profiles of patients, emphasizing the roles of the renin-angiotensin-aldosterone system and the autonomic nervous system. METHODS: This is a prospective, single-center, observational study including 77 patients who underwent LAA closure by an epicardial (n = 38) or endocardial (n = 39) device. Key hormones involved in the adrenergic system (adrenaline, noradrenaline), renin-angiotensin-aldosterone system (aldosterone, renin), metabolic system (adiponectin, free fatty acids, insulin, ß-hydroxybutyrate, and free glycerols), and natriuresis (atrial and B-type natriuretic peptides) were assessed immediately before the procedure, immediately after device deployment, at 24 h, and at 3 months follow-up. RESULTS: In the endocardial LAA device group, when compared with baseline blood adrenaline, noradrenaline and aldosterone were significantly lower at 24 h and 3 months (p < 0.05). There was no significant change in levels post-endocardial LAA device implantation. After epicardial LAA device implantation, there were significant increases in adiponectin and insulin, with decreased free fatty acids at 3 months. There was no significant change in these levels post-endocardial LAA device. N-terminal pro-A-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide were significantly decreased in the acute phase after epicardial LAA device implantation, which subsequently normalized at 3 months. Post endocardial LAA device implantation, the levels increased immediately and normalized after 24 h. Systemic blood pressure was also significantly lower at all time points after epicardial LAA device implantation, which was not seen post-endocardial LAA device implantation. CONCLUSIONS: There are substantial differences in hemodynamics and neurohormonal effects of LAA exclusion with epicardial and endocardial devices. Further studies are required to elucidate the underlying mechanism of these physiological changes.

Propensity-Score Matched Comparison of the Cera PFO Occluder With the Amplatzer PFO Occluder for Percutaneous Closure of Patent Foramen Ovale Without Echocardiographic Guidance.

BACKGROUND: Percutaneous patent foramen ovale (PFO) closure has become a routine procedure and was proven to be safe and feasible. In a recently published pooled analysis of randomized trials, percutaneous PFO closure was shown to more effectively reduce recurrent stroke when compared with medical therapy in patients with cryptogenic strokes. However, procedural safety and closure rate are device dependent. METHODS: We performed a propensity-score matched comparison of 28 patients undergoing percutaneous PFO closure using the Cera PFO occluder (CPO) with 28 patients who received the Amplatzer PFO occluder (APO). The main endpoints were procedural complications and closure rate at 6 months verified by transesophageal echocardiography. RESULTS: The implantation procedure using the CPO was successful and without complications in all cases. After propensity-score matching, there was no significant difference between groups for the primary endpoint of residual shunt at 6 months (7% in the CPO group vs 4% in the APO group; log-rank test P=.15). CONCLUSIONS: With regard to procedural safety and closure rate at 6 months, the performance of the CPO is comparable with the APO in this small patient cohort.

Perimembranous Ventricular Septal Defect Device Closure: Choosing Between Amplatzer Duct Occluder I and II.

Transcatheter closure of perimembranous ventricular septal defects (pmVSDs) is a well-established procedure. Recently, Amplatzer duct occluders (ADO) I and II have been reported to close large series of pmVSDs successfully (off-label use). ADOs are economical compared with the standard Amplatzer VSD occluders, a major consideration in developing countries with low-budget programs. We report closure of symptomatic, hemodynamically significant pmVSDs using the ADOI and ADOII devices. Although there are no set criteria for choosing between ADOI and ADOII, the former's price tag includes snare and long sheath. Thus, we aim to predetermine device usage based on transthoracic echocardiography (TTE) findings. Between March 2013 and November 2014, 30 patients had transcatheter closure of pmVSDs using the ADO devices. The median age was 4 years (range 1.1-13 years) and median weight was 15 kg (range 6.5-85 kg). ADOII could not be used in VSDs larger than 6 mm and/or with a large aneurysm. The median VSD size as assessed by echocardiography was 5.5 mm while the mean was 5.5 mm (range 3-12 mm); while by angiography it was 5 mm & the mean was 4.75 mm (range 3-9 mm). The median fluoroscopy time (FT) was 8 min (range 5-38 min). We inserted ADOI in 13 patients and ADOII in 17 patients (no significant difference between median age and weight in each group). VSD size was significantly larger and FT was longer in ADOI patients; the device type matched what was decided from TTE data in 84% of cases. Follow-up ranged from 2 to 24 months (median 12 months). The mean LVEDD z-score of the patients was 1.1 before VSD closure, while it was 0.63, 0.35, and 0.23 at the 1-, 3 months, and last follow-up, respectively. Complete closure rates immediately, at 24 h, and at last follow-up were 87, 90, and 94% respectively. No patient developed heart block or any other complication. ADOI and ADOII are equally safe and effective in pmVSD closure. ADOII use, although cheaper than ADOI, is limited to smaller VSDs. The choice between ADOI and ADOII can be decided by TTE prior to procedure which is convenient in low economic programs.

Long-Term Contrast Echocardiography and Clinical Follow-Up after Percutaneous Closure of Patent Foramen Ovale Using Two Different Atrial Septal Occluder Devices.

INTRODUCTION: Percutaneous patent foramen ovale (PFO) closure by means of a septal occluder device (SOD) is a well-known therapeutic strategy for the secondary prevention of paradoxical embolic neurological events. The aim of this study was to provide long-term echocardiographic and clinical follow-up data on patients who had undergone percutaneous PFO closure with 2 different SOD. METHODS: We selected 2 groups of patients treated with 2 different SOD: Group A: 52 patients with an Amplatzer(®) PFO Occluder and Group B: 49 patients with a Figulla Flex(®) device. All patients underwent follow-up Bubble Test Transthoracic Echocardiography (BTTE) and clinical examination. The results were compared with those recently reported in a group of patients with similar characteristics, but that had been treated conservatively, which acted as a control group. RESULTS: The mean follow-up after PFO closure was 53 months. The Amplatzer(®) PFO Occluder and the Figulla Flex were used in 52 (51.5%) and 49 (48.5%) of patients, respectively. We found no significant difference in the rate of effective PFO closure between the devices: Amplatzer 91.4%, Figulla 93.9% (P = 0.71). One patient (1.0%) suffered a recurrent neurologic event. BTTE was positive (BTTE+) in 8 patients (8%), 5 with an Amplatzer, and 3 with a Figulla device (P = 0.516). Only 1 patient with BTTE+ had a recurrent TIA (12.5%). No significant relationship was found between device dimensions and BTTE+ (P = 0.062). In the control group (163 patients), the recurrence of neurologic events was 9.2% (15 events), that was significantly higher in respect to the patients who had undergone percutaneous closure of the PFO. CONCLUSIONS: Percutaneous PFO closure was associated with a remarkably low risk of recurrent embolic neurological events, and no long-term device-related major complications. No statistically significant difference emerged between the 2 different SODs regarding BTTE positivity. Long-term follow-up showed that the recurrence of neurological events has been significantly higher in the group treated in a conservative way.

Side-by-Side Comparison of LAA Occlusion Performance With the Amplatzer Cardiac Plug and Amplatzer Amulet.

BACKGROUND: The Amplatzer Amulet, a second-generation device for left atrial appendage occlusion (LAAO), has been designed to facilitate the implantation process, improve the closure performance, and reduce the risk of complications. The objective of this study was to compare the outcomes of the Amplatzer Cardiac Plug (ACP) with the Amplatzer Amulet for LAAO, with a special focus on the incidence of residual leaks. METHODS: This was a prospective, single-center review of consecutive patients undergoing percutaneous LAAO with either ACP or Amulet devices. The first transesophageal echocardiography (TEE) at follow-up (1-3 months) was utilized to assess the occurrence of residual leaks. RESULTS: Between November 2009 and August 2013, a total of 59 patients underwent LAAO with either the ACP device (n = 31) or Amulet device (n = 28). The device was successfully implanted in 58 patients (98.3%). There was no procedural device embolization, stroke, or cardiac tamponade. Follow-up TEE was available in 86% (50 patients; 25 ACP devices and 25 Amulet devices). At follow-up, there was no procedural device embolization, and only 1 patient who received an Amulet device presented with device thrombosis at follow-up. Amulet use was associated with a significant reduction of any leak (minor, moderate, or major) compared with ACP use (48% ACP vs 8% Amulet; P=.01). CONCLUSION: In this initial series, the Amulet showed similar procedural and short-term clinical outcomes compared with the ACP. The Amulet was, however, associated with a significant reduction of residual leaks at follow-up.

Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure. Multicenter clinical experience.

AIM: The Ceraflex atrial septal defect occluder is an alternative device to the Amplatzer septal occluder with some structural innovations including flexible connection, increased flexibility, and minimized amount of implant material. We evaluated the efficiency and safety of the Ceraflex septal occluder device in percutaneous closure of secundum atrial septal defects. PATIENTS AND METHODS: This was a prospective, nonrandomized, multicenter study of patients undergoing transcatheter closure for an atrial septal defect with the Ceraflex and the Amplatzer septal occluder devices. A clinical evaluation and follow-up transthoracic echocardiography were performed at 1, 6, and 12 months. RESULTS: Between 2010 and 2014, 125 patients underwent atrial septal defect closure with the Ceraflex septal occluder (n = 58) and the Amplatzer septal occluder (n = 67) under transesophageal echocardiography guidance. Patient characteristics, the stretched size of the defect, device size, and fluoroscopy time were similar between the groups. The immediate and follow-up complete occlusion rates for both groups were 100%. There was no device embolization, procedure-related stroke, or pericardial effusion. CONCLUSIONS: The Ceraflex septal occluder is a safe and efficient device for closure of secundum atrial septal defects with no procedural complications. The Ceraflex has similar outcomes when compared with the Amplatzer septal occluder device. The advantage of the Ceraflex septal occluder device is that it can be deployed without the tension of the delivery catheter.

Percutaneous closure of medium and large PDAs using amplatzer duct occluder (ADO) I and II in infants: safety and efficacy.

BACKGROUND: The use of the Amplatzer duct occluder (ADO; AGA Medical Corporation) is well established and reported in children and adults, but there are only occasional reports on use in symptomatic infants. METHODS AND RESULTS: Between March 2009 and January 2011, a group of 47 infants less than 2 years of age with symptomatic patent ductus arteriosus (PDA) was treated using ADO I and II devices. Patients were divided into infants less than 1 year old (group A; n = 28/47; 59.6%) and children between 1 and 2 years old (group B; n = 19/47; 40.4%). Physical examinations and echocardiograms were performed before the procedure and at follow-up (3, 6, and 12 months). Mean age was 5.3 ± 2.3 months for group A and 12.6 ± 1.7 months for group B. Mean weight at closure was 4.8 ± 1.9 kg for group A and 7.3 ± 2.1 kg for group B. ADO I was deployed in 19/28 of group A (67.9%) and 16/19 of group B (84.2%). ADO II was used in 9/28 of group A (32.1%) and 3/19 of group B (15.8%). No residual shunt at the end of the procedure was detected by angiography in any of the cases closed with ADO I and only 3/12 (25%) closed with ADO II showed a minimal residual flow. No mortality or major complications occurred. Six months after closure, weight gain, control of respiratory infections, and regression of left ventricular dilatation with improved systolic function were observed. CONCLUSIONS: Percutaneous closure of moderate to large PDAs using ADO I and II devices in infants and children younger than 2 years of age is safe and effective.

Medium-term results of transcatheter closure of patent foramen ovale (PFO) with Amplatzer PFO and Cribriform occluders.

BACKGROUND: The use of an Amplatzer Cribriform Septal Occluder (ACSO) for percutaneous patent foramen ovale (PFO) closure (especially in cases with atrial septal aneurysm) has been recently described as superior compared to that of an Amplatzer PFO Occluder (APFO). AIM: To assess immediate and medium-term clinical outcomes of patients with PFO with paradoxical embolism event (EE) who underwent transcatheter PFO closure with an APFO or an ACSO. METHODS: Overall, 56 consecutive patients underwent percutaneous closure of PFO with an APFO device; the results were compared to those in seven patients treated with ACSO. Deaths due to embolism, stroke or transient ischaemic attack (TIA) were considered recurrent EE. Pre- and 6 month post-intervention right to left shunting (RLS) were evaluated with intravenous contrast injection by transcranial Doppler examination of the middle cerebral artery during Valsalva manoeuvre. RESULTS: The procedure was successfully completed in all patients in both groups. No procedure-related complications were observed during hospitalisation. Residual RLS was noted at six months in 14/56 (25%) patients in the APFO group and 4/7 (57%) patients in the ACSO group (p <0.05). Recurrent TIA was observed in three patients in the APFO group (one of them had small residual shunt immediately after procedure and at six-month follow-up). Another patient from that group experienced stroke one month after the procedure. No recurrence of EE was recorded in the ACSO group. CONCLUSIONS: Transcatheter PFO closure with both Amplatzer devices is a minimally invasive procedure with high success and low complication rates. Taking in consideration residual RLS in the medium-term period, the application of a Cribriform device is not superior to that of an Amplatzer PFO device. Results of randomised trials are necessary to confirm the effectiveness of transcatheter therapy in patients with PFO and a paradoxical thromboembolic event.

Contraction of the Amplatzer Vascular Plug I and II in pulmonary artery and systemic venous collateral vessels is safe and of no hemodynamic or vascular consequence in short- and mid-term follow-up.

BACKGROUND: The Amplatzer Vascular Plug (AVP) I and AVP II have been used successfully to occlude moderate-large venous collateral vessels (VC) and pulmonary arteriovenous malformations (PAVM) in children and adults with congenital heart disease. PURPOSE: To report our experience in 4 patients who underwent device occlusion of systemic venous collaterals (3 patients) and device closure of pulmonary arteriovenous malformation (1 patient) that developed contraction of the AVP. METHODS: The records of all patients who underwent device occlusion utilizing both AVP I and AVP II between November 2006 and January 2011 were retrospectively reviewed. All available follow-up chest x-rays were reviewed and compared with angiograms obtained post device occlusion. A device 30%-50% larger than the targeted vessel was utilized to occlude the vessel. RESULTS: Four patients were identified with a mean age of 21 years (range, 7 years and 2 months-52 years) and mean weight of 60.6 kg (range, 15.3-131.5 kg). Two patients received AVP I and 2 patients received AVP II. One patient who received the 12 mm AVP I showed moderate contraction. The 3 other patients who received AVP I (6 mm) and AVP II (10 mm, 12 mm) all demonstrated device contraction to the original shape of the device. Mean follow-up time of 24 months (range, 12-40 months) has shown no evidence of hemodynamic or vascular compromise. CONCLUSIONS: Short to mid-term follow-up indicate that contraction of AVP I and AVP II is safe with no evidence of hemodynamic or vascular compromise. Continued long-term follow-up is warranted.

Analysis of maximum P-wave duration and dispersion after percutaneous closure of atrial septal defects: comparison of two septal occluders.

OBJECTIVE: Amplatzer septal occluder (ASO) is the most widely used device for closure of atrial septal defect (ASD). Figulla septal occluder (FSO) is a similar device to ASO with some structural innovations. The aim of study is to assess the maximum P-wave duration (Pmax) and dispersion (Pd) in patients who underwent ASD closure with both devices, to determine the effects of structural innovations on atrial electrical inhomogeneity. METHODS: The study is a retrospective cohort analysis. Between December 2005 and March 2010, 121 patients underwent percutaneous closure of secundum ASD were included in this study. FSO was used in 79 patients, ASO in 42 patients. Pmax and Pd were measured on the surface electrocardiography before and soon after procedure. For comparison of P-wave parameters initially and after procedure paired t-test was used. Correlation analysis was performed using Pearson correlation test. RESULTS: Pmax and Pd were significantly increased immediate after procedure (p<0.001). In FSO and ASO group pre/postprocedural Pd were 38.3 ± 2.7/ 44.1 ± 2.7 msec and 37.5 ± 2.5/ 50.1 ± 2.2 msec respectively. ASO group had a greater postprocedural Pmax and Pd (p<0.001). Left and right atrial disc diameter and device size were the strongest correlates of Pd (r=0.52, p<0.001; r=0.58, p<0.001; r=0.35, p=0.001, respectively). Moderate correlation was found between pre-intervention Pd and age (p=0.008). CONCLUSIONS: Pmax and Pd were significantly increased soon after atrial septal defect closure procedure in both devices. Pd is significantly lower in patients closed with FSO device. Difference may be due to the distinctive texture of devices. There was no significant difference in terms of clinically apparent arrhythmia after closure with both device types.

Successful transcatheter closure of a Fontan fenestration with a bioabsorbable Biostar occluder.

We report the successful closure of an extracardiac Fontan fenestration with a bio-absorbable device, which may be refenestrated by a transcatheter route when needed, in a 10-year-old boy. The patient presented with cyanosis two years after an extracardiac Fontan operation. Echocardiography revealed a moderate shunt from the Fontan circulation into the systemic circulation with a mean pressure gradient of 3-4 mmHg. Treadmill testing revealed a significant decrease in oxygen saturation (down to the low 50's from a baseline level of 80-85%). Cardiac catheterization revealed normal pressure in the Fontan circuit. A temporary balloon occlusion test showed that the defect was suitable for permanent occlusion. The fenestration was then occluded by a bio-absorbable Biostar (NMT medical, Boston, USA) atrial septal occluder device. The oxygen saturation on room air increased up to 95% after closure.

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.