Amplatzer Vascular Plug Research Articles

ASSA14-14-05 Initial experience of occluding special type patent ductus arterioses using the Amplatzer vascular plug I

<h3>Background</h3> Occluders licensed for clinical use are not fit for some special Krichenko E patent ductus arterioses (PDA). The Amplatzer vascular plug I (Plug I) has not been licensed for use for closure of PDA. We report our initial experience to occluding special type PDA with the Plug I. <h3>Methods</h3> Patients referred with small and long Krichenko E PDA 1–3 mm in diameter underwent occlusion using this Plug I, this is a single lobe device of single layer Nitinol mesh for short vessel landing zones. All cases underwent pre-, intra- and post-procedural echocardiography at the completion of the procedure the next day and at a 30-day follow-up visit. Device sizing for device waist diameter and length was based on aortography. <h3>Results</h3> 26 patients with a median age of 5 years (range 6 months – 32 years) and a median weight of 19 kg (range 7–67 kg) underwent successful PDA closure. The median ductus diameter was 2.2 mm (range 1–3 mm). Both transpulmonary (22/26) and transaortic approaches (4/26) were used. No persistent patency was observed after 24 h and one month. <h3>Conclusions</h3> The Plug I Makes it easy to close some Krichenko E PDAs. Smaller delivery catherter profile and symmetric cylindrical device shape allow for use for small and long Krichenko E PDA 1–3 mm in diameter and small patients through transaortic approaches. Broader experience is required to further delineate device and patient selection as well as to document its long-term efficacy and safety.

Percutaneous embolization of symptomatic dissecting aneurysms of the celiac artery

Isolated spontaneous dissection of visceral arteries, not associated with aortic dissection, is a rare condition. To date, there is no consensus on the optimal treatment strategy. To investigate the feasibility, efficacy, and safety of percutaneous embolization for the treatment of isolated and symptomatic dissecting aneurysm of the celiac artery. From March 2010 to October 2011, four patients were diagnosed at our institution with symptomatic dissecting aneurysm of the celiac trunk. All patients had acute abdominal pain, two had intra-abdominal hemorrhage and bleeding shock. Three patients underwent elective "trapping" embolization of the celiac trunk with Amplatzer vascular plugs in the hepatic and splenic artery and celiac trunk, and coils in left gastric artery. One patient had a splenic artery rupture and underwent selective embolization of this vessel with platinum-fiber coils. Angiography and postoperative CT scan confirmed artery occlusion after embolization in all cases. Revascularization of celiac trunk branches was obtained via collaterals. No procedure-related adverse events occurred during follow-up (median, 4.5 months; range, 3-24 months) and vessel occlusion was maintained. Isolated and symptomatic dissecting aneurysm of the celiac trunk can be successfully managed by embolization techniques with good short- to mid-term results.

Early Experience with the AMPLATZER Vascular Plug IV for the Occlusion of Pulmonary Arteriovenous Malformations

The recent generation of AMPLATZER Vascular Plug (AVP; ie, the AVP IV) was used for the occlusion of eight pulmonary arteriovenous malformations (PAVMs) in five patients. A treatment was considered successful when there was a reduction or disappearance of the aneurysmal sac. At a mean follow-up of 20.1 months, no recanalization of PAVMs was observed on multidetector computed tomographic angiography. This shows the AVP IV to be safe and effective as an embolic device to occlude PAVMs.

Amplatzer vascular plug for patent ductus arteriosus migrated to pulmonary artery six months after closure in a 59 year old female

Amplatzer vascular plug for patent ductus arteriosus migrated to pulmonary artery six months after closure in a 59 year old female

O-027 Micro Vascular Plug (MVP) Assisted Vessel Occlusion in Neurovascular Pathologies: Technical Results and Initial Clinical Experience

PurposeEndovascular vessel occlusion may be necessary to treat a variety of neurovascular pathologies such as pseudo-aneurysms and giant aneurysms, iatrogenic and penetrating vascular injuries and direct arteriovenous fistulas of the...

Evolución inmediata y a medio plazo de las dehiscencias paravalvulares cerradas percutáneamente

Introduction and objectivesPercutaneous closure of paravalvular leakage is an alternative to surgery in high-risk patients, but its use has been limited by a lack of specific devices. More appropriate devices—like the Amplatzer Vascular Plug III—have recently been developed, but information about their efficacy and safety is still scarce. The objective of the present study was to assess the mid-term results of paravalvular leakage closure with this device. MethodsWe analyzed the clinical and echocardiographic course both in-hospital and mid-term (13 [9] months) in a series of 20 consecutive patients (age, 68 years; logistic EuroSCORE, 29) with paravalvular leakage and attempted percutaneous closure. ResultsClosure was attempted for 23 leaks (17 mitral and 6 aortic) during 22 procedures in 20 patients. Implantation was successful in 87% of the leaks and the procedure was successful in 83%—with success being defined as a reduction in regurgitation of ≥ 1 degree. Survival at 1 year was 64.7% and survival free of the composite event of death/surgery was 58.8%. The degree of residual regurgitation was not associated with mortality but was associated with functional status. Survivors showed significant improvement in functional class. ConclusionsPercutaneous closure of leakage with the Amplatzer Vascular Plug III is safe and efficient in the mid-term. However, mortality among high-risk patients is high independently of the degree of residual regurgitation, indicating that these procedures are performed when heart disease has reached an advanced stage.Full English text available from:www.revespcardiol.org/en

Immediate and Mid-term Clinical Course After Percutaneous Closure of Paravalvular Leakage

Introduction and objectivesPercutaneous closure of paravalvular leakage is an alternative to surgery in high-risk patients, but its use has been limited by a lack of specific devices. More appropriate devices—like the Amplatzer Vascular Plug III—have recently been developed, but information about their efficacy and safety is still scarce. The objective of the present study was to assess the mid-term results of paravalvular leakage closure with this device. MethodsWe analyzed the clinical and echocardiographic course both in-hospital and mid-term (13 [9] months) in a series of 20 consecutive patients (age, 68 years; logistic EuroSCORE, 29) with paravalvular leakage and attempted percutaneous closure. ResultsClosure was attempted for 23 leaks (17 mitral and 6 aortic) during 22 procedures in 20 patients. Implantation was successful in 87% of the leaks and the procedure was successful in 83%—with success being defined as a reduction in regurgitation of ≥ 1 degree. Survival at 1 year was 64.7% and survival free of the composite event of death/surgery was 58.8%. The degree of residual regurgitation was not associated with mortality but was associated with functional status. Survivors showed significant improvement in functional class. ConclusionsPercutaneous closure of leakage with the Amplatzer Vascular Plug III is safe and efficient in the mid-term. However, mortality among high-risk patients is high independently of the degree of residual regurgitation, indicating that these procedures are performed when heart disease has reached an advanced stage.

Immediate Closure of Paravalvular Leak After Transcatheter Aortic Valve Implantation

Trans catheter aortic valve implantation (TAVI) is increasingly used to treat severe aortic stenosis (AS) in surgical highrisk groups. Mortality and reduction in symptoms were similar in the two groups [1]. Para valvular leak (PVL) was more common in the TAVI group [1] and is an independent predictor of mortality [1]. We report a case of successful immediate closure of moderate to severe PVL with an Amplatzer Vascular Plug III (AVP III). A 75 year-old female presented with severe symptomatic AS. Logistic Euroscore was 35% and STS mortality score was 15%. The aortic annulus diameter by transthoracic echocardiogram was 22 mm. CT reconstruction (3 Mensio Medical Imaging BV, Netherlands) showed annulus perimeter of 76 mm and area 438 mm. There was significant calcium deposition at the annulus (Figure 1e). A 23 mm Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California) was chosen for TAVI. Due to tortuous and calcific illio-femoral arteries, trans-aortic access was used for TAVI. Following valve implantation trans-oesophageal echocardiography (TEE) showed moderate to severe PVL (Figure 1a & 1c). Dilatation of the valve with a 45 x 25 mm Cristal balloon (BALT, France) failed to reduce PVL. Due to concern that the first valve was deployed too high another Sapien XT 23 mm

80 Importance of 3D Tee in Procedure Success of Percutaneous Paravalvular Leak Closure

PurposeParavalvular leaks (PVL) are a recognised complication post surgery, but rarely result in heart failure and haemolysis. Redo surgery may present technical challenges and is associated with significant morbidity and...

Conventional surgery and transcatheter closure via surgical transapical approach for paravalvular leak repair in high-risk patients: results from a single-centre experience.

Paravalvular leaks (PVL) occur in up to 17% of all surgically implanted prosthetic valves. Re-operation is associated with high morbidity and mortality. Transcatheter closure via a surgical transapical approach (TAp) is an emerging alternative for selected high-risk patients with PVL. The aim of this study was to compare the in-hospital outcomes of patients who underwent surgery and TA-closure for PVL in our single-centre experience. From October 2000 to June 2013, 139 patients with PVL were treated in our Institution. All the TA procedures were performed under general anaesthesia in a hybrid operative room: in all but one case an Amplatzer Vascular Plug III device was utilized. Hundred and thirty-nine patients with PVL were treated: 122 patients (87.3%) underwent surgical treatment (68% mitral PVL; 32% aortic PVL) and 17 patients (12.2%) underwent a transcatheter closure via a surgical TAp approach (all the patients had mitral PVL; one case had combined mitral and aortic PVLs); in 35% of surgical patients and in 47% of TAp patients, multiple PVLs were present. The mean age was 62.5 ± 11 years; the Logistic EuroScore was 15.4 ± 3. Most of the patients were in New York Heart Association (NYHA) functional class III-IV (57%). Symptomatic haemolysis was present in 35% of the patients, and it was particularly frequent in the TAp (70%). Many patients had >1 previous cardiac operation (46% overall and 82% of TAp patients were at their second of re-operation). Acute procedural success was 98%. In-hospital mortality was 9.3%; no in-hospital deaths occurred in patients treated through a TAp approach. All the patients had less than moderate residual valve regurgitation after the procedure. Surgical treatment was identified as a risk factor for in-hospital death at univariate analysis (OR: 8, 95% CI: 1.8-13; P = 0.05). Overall actuarial survival at follow-up was 39.8 ± 7% at 12 years and it was reduced in patients who had >1 cardiac re-operation (42 ± 8 vs. 63 ± 6% at 9 years; P = 0.009). A transcatheter closure via a surgical TAp approach appears to be a safe and effective therapeutic option in selected high-risk patients with PVL and is associated with a lower hospital mortality than surgical treatment, in spite of higher predicted risk. Long-term survival remains suboptimal in these challenging patients.

A novel technique for transcatheter patent ductus arteriosus closure in extremely preterm infants using commercially available technology.

To describe a new technique for transcatheter patent ductus arteriosus (PDA) closure in extremely preterm infants using commercially available technology. PDA in premature neonates continues to be a significant clinical problem contributing importantly to both morbidity and mortality. Surgical ligation and medical therapy both have their drawbacks. Hospital records and catheterization reports of all premature neonates (< 32 weeks gestation) who underwent transcatheter PDA closure between March 2013 and February 2014 were reviewed. Particular attention was paid to procedural details, complications, and short and mid-term outcomes. Six premature infants born at gestational ages ranging between 26 and 31 weeks (median, 26 weeks) underwent attempted transcatheter PDA closure using the Amplatzer Vascular Plug II (AVP II). Median age and weight was 21.5 days (16-80 days) and 1,180 g (870-2,240 g), respectively. Fluoroscopy and echocardiography were used to guide device. Contrast angiography was not used in any patient. Complete closure was achieved in all patients with no major procedural complications. Median fluoroscopy and procedural times were 9.4 (0-19.5) and 51.5 (33-87) min, respectively. All patients were alive at the time of this report. There were no instances of device migration, left pulmonary artery (LPA), or aortic coarctation. This preliminary study demonstrates that transcatheter PDA closure can be successfully performed in extremely preterm neonates using currently available technology with a high success rate and a low incidence of complications. This report also describes a novel transvenous approach using a combination of echocardiography and judicious use of fluoroscopy to avoid arterial access in this fragile patient population. © 2014 Wiley Periodicals, Inc.

Hybrid approach for transcatheter paravalvular leak closure of mitral prosthesis in high-risk patients through transapical access

To report "hybrid" procedure feasibility and the clinical success of transcatheter paravalvular leak closure through apical access. Seven patients (73.6±6.1 years; 4 men) with severe mitral prosthesis paravalvular leak were selected. All patients were at high risk for open surgery because of severe comorbidities and heart failure (New York Heart Association class III-IV). The defect size was 25±7.8 mm in the long axis and 9.3±2 mm in the short axis. Two defects were detected in 2 patients. The transapical procedure was performed in a "hybrid" surgery room using minithoracotomy and general anesthesia. Three-dimensional transesophageal echocardiography and fluoroscopy were used for imaging. A total of 19 Amplatzer Vascular Plug III devices (St Jude Medical) were implanted in 7 patients, 2.7/patient and 1 to 3/fistula. The procedure time was 150.7±66.8 minutes. In 6 of 7 patients (85.7%), the paravalvular leak was successfully closed, resulting in no or mild residual regurgitation. One patient had moderate regurgitation despite deployment of 3 Amplatzer Vascular Plug III devices. Two patients required blood transfusion related to procedural blood loss. The patients were discharged at 15.3±6.5 days and followed up at 215.7±138.6 days. All but 1 patient reported symptomatic improvement by ≥1 New York Heart Association class at follow-up. One patient died 216 days postoperatively. A "hybrid approach" for transcatheter paravalvular leak closure of mitral prosthesis from the apical route is effective in reducing the regurgitation grade and improving functional capacity in high-risk patients. Complete closure of the defect was maintained at follow-up in most patients.

Evaluating Patent Ductus Arteriosus during Percutaneous Closure: Correlation between Intravascular Ultrasonography and Computed Tomographic Angiography

A 39-year-old man presented with dyspnea on exertion and was found on ausculation to have a continuous machinery-like murmur. A computed tomographic (CT) angiogram with 3-dimensional reconstruction showed a tubular patent ductus arteriosus (PDA) that measured 1.7 × 1.3 cm in diameter (Figs. 1 and ​and2).2). Given the large size of the defect, we entered the PDA with a peripheral intravascular ultrasound catheter (Volcano Corporation; San Diego, Calif ) to obtain ultrasonographic images (Fig. 3), which precisely confirmed the dimensions shown on the CT scan. Because of the defect's large size, we used an Amplatzer™ 20-mm vascular plug II (St. Jude Medical, Inc.; St. Paul, Minn) for closure (Fig. 4). Multiple aortograms verified cessation of left-to-right flow across the PDA, consistent with occlusion of the PDA (Fig. 5). Fig. 1 Coronal image of a contrast-enhanced computed tomographic scan shows a large patent ductus arteriosus (1.7 × 1.3 cm). Fig. 2 Three-dimensional reconstruction of a contrast-enhanced computed tomographic scan shows a large patent ductus arteriosus. Fig. 3 Intravascular ultrasonographic image of a large patent ductus arteriosus (1.7 × 1.3 cm). Fig. 4 Aortogram shows placement of the Amplatzer™ 20-mm Vascular Plug II within the patent ductus arteriosus. Fig. 5 Aortogram shows closure of the patent ductus arteriosus with use of the Amplatzer Vascular Plug.

In Vitro Evaluation of the Occlusive Properties of Latex-Covered Amplatzer Vascular Plugs for Transrenal Ureteral Occlusion

To evaluate the occlusive properties of latex-covered Amplatzer Vascular Plugs (AVPs) for transrenal ureteral occlusion in vitro. Latex-covered AVPs type I and II (diameter 8, 10, 12, 14, and 16 mm) were used as occlusive devices. Radial force of an AVP was measured using simulated ureteral diameters of 4 to 12 mm. Occlusive properties were examined in a silicone tube (inner diameter 6 mm) with measurement of drainage time of a 40 cm water column. In complete occlusion, the maximum pressure that the plug was able to withstand was determined at different temperature levels. Statistical analysis of drainage time was performed in a general linear model (GLM) and using correlation analyses. Explanted porcine ureters were used to simulate physiologic conditions. Pressure measurements were performed until leakage, plug dislocation, or rupture of the ureter occurred. Radial force depended on AVP type, size, ureteral diameter, and temperature. The 16-mm AVP II showed the highest radial force of more than 5 N (ureteral diameter 4 mm, body temperature). All AVP I showed water leakage and plug dislocation. Drainage time of the AVP II depended significantly on plug size and temperature and correlated with radial force (r=0.731, P<0.001). In complete occlusion, water leakage occurred at 500 to 1000 cm H2O and dislocation between 500 to more than 2000 cm H2O. In porcine ureters, leakage occurred at room temperature between 19 to 93 cm H2O. At body temperature, all AVP II occluded the ureter completely. Latex-covered AVP II (diameter 8-16 mm) can effectively occlude the ureter, especially considering remodeling of the nitinol at body temperature. Large plug diameters can exert enough radial force even in dilated ureters to allow for successful occlusion. Because deployment of a 16-mm latex-covered AVP II can be technically difficult, we advocate the use of 12- or 14-mm AVP II for transrenal ureteral occlusion. AVP Is are not suitable for ureteral occlusion.

Large Pulmonary Arteriovenous Malformations: Long-Term Results of Embolization with AMPLATZER Vascular Plugs

PurposeTo analyze the long-term results of endovascular treatment of large pulmonary arteriovenous malformations (PAVMs) using the AMPLATZER vascular plug (AVP; AGA Medical Corp, Golden Valley, Minnesota). Materials and MethodsBetween May 2007 and April 2011, 18 patients with 24 large PAVMs, defined as PAVMs that had a feeding artery with a diameter of ≥ 8 mm, were treated with AVP I or AVP II. A single AVP device was used for each PAVM. Aneurysmal sac diameters, sac perfusion, sac shrinkage, and complete resolution before and after the intervention were analyzed. Complete histories, laboratory values, physical examinations, and multidetector computed tomography images were reviewed. The mean occlusion time for AVP I and AVP II and the mean arterial oxygen saturation (SaO2) before and after the intervention were compared. ResultsThe mean diameter of the feeding artery was 11.46 mm ± 2.18 (range, 8–13.3 mm). The mean occlusion time was 7.34 minutes ± 1.23 for AVP I and 6.25 minutes ± 1.12 for AVP II (P = .11). The mean SaO2 before and after the intervention was 63.71% ± 8.10% (range, 51%–76%) and 96.28% ± 0.49% (range, 96%–97%), respectively (P = .045). No major periprocedural complications were observed. The mean follow-up duration was 36.33 months ± 10.63 (range, 28–56 mo). During the follow-up period, there were no persistent sac perfusions, migration of the AVPs, major complications, or recanalizations. ConclusionsTreatment of large PAVMs with AVPs is an effective method for obtaining excellent long-term results. Embolization of large feeding arteries can be accomplished with AVPs without major complications.

Abstract No. 396 - Transradial deployment of amplatzer vascular plug 4 in visceral vessels prior to radioembolization: feasibility and technical considerations

The Amplatzer Vascular Plug 4 (AVP4) has been successfully utilized for arterial occlusion prior to selective internal radiation therapy (SIRT) due to its ease of deployment and high technical success rate. Failure at AVP4 implantation has been observed to occur in the setting of an acutely angled celiac trunk. The purpose of this study is to determine the technical success and effectiveness of placing the AVP4 from a transradial approach (TRA) during mapping study prior to SIRT.

8:00 AM; Abstract No. 165 - Vascular plug-assisted retrograde transvenous obliteration for the treatment of gastric varices and hepatic encephalopathy

Purpose To evaluate the technical and clinical safety and the efficacy of Amplatzer Vascular Plug (AVP)-assisted retrograde transvenous obliteration (PARTO) for the treatment of gastric varices (GV) and hepatic encephalopathy (HE). Materials and Methods From April 2009 to December 2011, we evaluated 20 patients (16 men and four women; mean age, 58 years; range, 47-79 years) who had undergone PARTO, 13 of whom had GV and seven who had HE. After retrograde transvenous placement of an AVP into the left adrenal vein, subsequent gelfoam embolization of both the gastrorenal shunt and the GV was performed. Results Placement of the AVP and subsequent gelfoam embolization were technically successful in all 20 patients. There were no procedure-related complications. Follow-up computed tomography (CT) obtained within one week after PARTO showed complete thrombosis of the GV and gastrorenal shunts in all patients. The clinical symptoms of HE were completely resolved in all seven patients with HE and the mean serum NH3 level, which was 127.4 umol/l ± 58 before PARTO, decreased significantly, to 28.1 umol/l ± 9.8, within one week after PARTO (p = 0.002). The clinical success rate was 100%. Improvement in the Child-Pugh score was observed in 12 of 18 patients (66.7%) at one month after PARTO. The mean follow-up period after PARTO was 422 days (range, 170-1168 days). Eighteen patients who had more than a two-month follow-up period, showed complete obliteration of the GV as well as the gastrorenal shunts on both CT and endoscopy. In these 18 patients, four (22.2%) experienced worsening of their esophageal varices at a mean of 9.4 months (range; 1-25 months) after PARTO. There were no cases of variceal bleeding or HE during a mean follow-up period of 422 days (range, 170-1168 days). Conclusion Our preliminary results suggest that PARTO is technically simple and safe and seems to be clinically effective for the treatment of GV and HE. We therefore believe that PARTO results in complete blockage of the gastrorenal shunt with a very high success rate. PARTO also has the potential to become a standard treatment for GV associated with a gastrorenal shunt either in patients with GV or in patients with HE.

Cerebrovascular Complications in a Patient with Hereditary Hemorrhagic Telangiectasia (HHT, Rendu–Osler Disease)

the patient developed new symptoms of vertigo and a rightsided scotoma within 5 days due to an infarction of the left peripheral posterial cerebral artery (PCA) territory. Shortly after her release from the hospital, the patient was readmitted with paresis of the left arm. Both computed tomography (CT) and MRI showed a recurrent abscess and an infarction of the left PCA territory (Fig. 2). After subsequent resurgery and intravenous antibiosis, the paresis of the left arm improved. However, 2 weeks later, the patient presented with seizure and sensory aphasia. Besides a residual abscess in the resection cavity, MRI showed a new hemorrhagic infarction in the left temporal lobe and subarachnoidal hemorrhage, as well as thrombosis of the left Labbe vein and the left transverse and sigmoid sinus (Fig. 3). CT of the thorax revealed a 3.5-cm-measuring AVM in the left upper lobe as well as various smaller AVMs in both lungs. As the most probable origin of embolization, the AVM was occluded using an Amplatzer vascular plug (AVP) and coils in subsequent catheter angiography (Fig. 4). MRI of the brain 2 weeks later showed regressive edema in the region of surgery and around the hemorrhagic infarction. With mild aphasia, impaired short-term memory, scotoma, and a decrease in fine motor skills, but no paresis, the patient was released into rehabilitation in an otherwise good general condition.

Cierre percutáneo de fugas periprotésicas con el dispositivo Amplatzer Vascular Plug III: resultados inmediatos y a corto plazo

Introduction and objectivesPercutaneous paravalvular leak closure is a complex procedure with varying success rates; the lack of closure devices specifically designed for this purpose has hampered this technique. The characteristics of the Amplatzer Vascular Plug III appear to be well suited for paravalvular leak closures; however, the available data are limited to case reports or small series of patients. The aim of this study was to analyze the feasibility and efficacy of paravalvular leak with this device. MethodsThe immediate and 90-day safety and efficacy of mitral and aortic paravalvular leak closures performed with this device at our hospital were analyzed. ResultsPercutaneous repair of 34 paravalvular leaks (27 mitral, 7 aortic) was attempted in 33 patients. The device was successfully implanted in 93.9% (in 2 patients, a second planned procedure was needed), and successful closure (defined as regurgitation reduction ≥ 1 grade) was achieved in 90.9% of patients. Complications included emergency surgery due to disc interference (n=1) and blood transfusion (n=3). There were no reports of procedure-related death, myocardial infarction, or stroke. At 90 days, survival was 100%, and 90.3% of patients showed significant clinical improvement; 4 patients developed vascular complications (pseudoaneurysm). ConclusionsMitral and aortic paravalvular leak closure with the Amplatzer Vascular Plug III is feasible and safe, with high clinical and echocardiographic success rates.Full English text available from:www.revespcardiol.org/en

Paravalvular Leak Closure With the Amplatzer Vascular Plug III Device: Immediate and Short-term Results

Introduction and objectivesPercutaneous paravalvular leak closure is a complex procedure with varying success rates; the lack of closure devices specifically designed for this purpose has hampered this technique. The characteristics of the Amplatzer Vascular Plug III appear to be well suited for paravalvular leak closures; however, the available data are limited to case reports or small series of patients. The aim of this study was to analyze the feasibility and efficacy of paravalvular leak with this device. MethodsThe immediate and 90-day safety and efficacy of mitral and aortic paravalvular leak closures performed with this device at our hospital were analyzed. ResultsPercutaneous repair of 34 paravalvular leaks (27 mitral, 7 aortic) was attempted in 33 patients. The device was successfully implanted in 93.9% (in 2 patients, a second planned procedure was needed), and successful closure (defined as regurgitation reduction ≥ 1 grade) was achieved in 90.9% of patients. Complications included emergency surgery due to disc interference (n=1) and blood transfusion (n=3). There were no reports of procedure-related death, myocardial infarction, or stroke. At 90 days, survival was 100%, and 90.3% of patients showed significant clinical improvement; 4 patients developed vascular complications (pseudoaneurysm). ConclusionsMitral and aortic paravalvular leak closure with the Amplatzer Vascular Plug III is feasible and safe, with high clinical and echocardiographic success rates.