Amplatzer Amulet™ left atrial appendage occluder: A step-by-step guide to device implantation.

Recently receiving Food and Drug Administration approval, the Amplatzer Amulet™ left atrial appendage occluder device (Abbott Medical Inc.) provides a dual seal mechanism alternative to the commercially available Watchman FLX or Watchman 2.5 device for embolic stroke prevention in patients with nonvalvular atrial fibrillation. This step-by-step review will cover patient selection, preprocedure imaging assessment, device sizing, device preparation, implant target position assessment, implant technique and troubleshooting, and immediate postimplant follow-up.

Consensus Guidelines for the Prevention and Management of Periprocedural Complications of Transcatheter Patent Ductus Arteriosus Closure with the Amplatzer Piccolo Occluder in Extremely Low Birth Weight Infants.

Transcatheter closure of patent ductus arteriosus (PDA) in premature infants is a feasible, safe, and an effective alternative to surgical ligation and may be performed with an implant success rate of 97%. Major procedural complications related to transcatheter PDA closure in extremely low birth weight (ELBW) infants are relatively infrequent (< 3%) ,but may be associated with a fatality if not optimally managed. Operators performing transcatheter PDA closures should be knowledgeable about these potential complications and management options. Prompt recognition and treatment are often necessary to avoid serious consequences. With strict guidelines on operator training, proctoring requirements, and technical refinements, transcatheter PDA closure in ELBW infants can be performed safely with low complication rates. This article summarizes the consensus guidelines put forward by a panel of physicians for the prevention and management of periprocedural complications of transcatheter PDA closure with the Amplatzer Piccolo Occluder in ELBW infants.

Delayed dislodgment of a watchman device: A rare complication manifesting as a transient ischemic event.

The role of left atrial appendage occlusion devices for stroke prevention in nonvalvular atrial fibrillation (AF) continues to expand. Device embolization is a rare but potentially catastrophic complication with variable clinical presentations. Here, we present a case of delayed dislodgment of a watchman device discovered on routine echocardiographic follow-up in a patient who later admitted to neurological symptoms. Urgent surgical device retrieval was performed with no further complications or neurological sequelae.

Surgical management of embolized Amplatzer septal occluder into the left ventricle tangled with the mitral valve.

Device embolization is a rare major complication of atrial septal defect percutaneous closures which requires surgical management if noninvasive retrieval fails. We report a symptomatic delayed embolization of an Amplatzer septal occluder device into the left ventricle outflow tract tangled with the mitral valve, complicated with ventricular arrhythmias and cardiac tamponade during percutaneous retrieval attempt. Emergent surgical treatment was performed, requiring a combined approach through the right atrium and the aorta for surgical removal.

Percutaneous retrieval of an embolized left atrial appendage closure device from the left atrium in a patient with previous MitraClips.

BACKGROUND: Left atrial appendage closure is increasingly used. LAA closure procedures can rarely be complicated by device embolization, typically towards the aorta. In this case report, we describe the successful percutaneous retrieval of an embolized Amulet device from the left atrium in a patient with previous MitraClips. CASE PRESENTATION: By guidance of intracardiac echocardiography (ICE) and under local anaesthesia, two guiding systems were introduced into the LA; one to stabilize the device against the lateral LA wall and one large system to retrieve the device. However, the LAA closure device was finally snared by a three-loop snare and pulled across the interatrial septum (IAS) without taking the device into a protective guiding sheath - and this without tearing the IAS. CONCLUSIONS: In conclusion, percutaneous retrieval of an embolized LAA closure device from the LA is feasible by transseptal approach under local anaesthesia and with ICE guidance.

Techniques for trans-catheter retrieval of embolized Nit-Occlud® PDA-R and ASD-R devices.

BACKGROUND: Nit-Occlud® (atrial septal defect) ASD-R and (patent ductus arteriosus) PDA-R devices are used outside the United States for percutaneous closure of the patent ductus arteriosus and atrial septal defects. When embolization occurs, these devices have been difficult to retrieve. METHODS: Bench simulations of retrieval of PDA-R and ASD-R devices were performed in a vascular model. Retrieval of each device was attempted using snare techniques or with bioptome forceps with a range of devices. The same devices were then intentionally embolized in an animal model. Retrieval methods were systematically tested in a range of sheath sizes, and graded in terms of difficulty and retrieval time. RESULTS: Devices that were grasped by the bioptome in the center of the proximal part of the devices were easily retrieved in both models. Bench studies determined the minimum sheath sizes needed for retrieval of each device with this method. In general sheathes two french sizes greater than the delivery sheath were successful with this technique. Three out of the four PDA-R devices were successfully retrieved in vivo. Two were retrieved by grasping the middle of the PA end of the PDA-R device with a Maslanka bioptome and one small PDA-R device was retrieved using a 10 mm Snare. Four of the five ASD-R devices were retrieved successfully grasping the right atrial ASD-R disc or by passing a wire through the device and snaring this loop. For ASD-R 28 and 30 mm devices, a double bioptome technique was needed to retrieve the device. CONCLUSION: ASD-R and PDA-R devices can be successfully retrieved in the catheterization lab. It is critical to grab the center portion of the right atrial disc of the ASD-R device or pulmonary portion of the PDA-R device and to use adequately sized sheathes.

TEVAR Rescue of an Embolized Edwards SAPIEN XT Valve Following TAVR.

PURPOSE: To report a successful method of managing an embolized Edwards SAPIEN XT aortic valve prosthesis using a thoracic endovascular aortic repair rescue. CASE REPORT: An 84-year-old man underwent transcatheter aortic valve replacement using a 26-mm Edwards SAPIEN XT valve, which immediately embolized into the ascending aorta. Because of the severe tapering of the patient's transverse aortic arch, the embolized valve was unable to be maneuvered further down the aorta. Therefore, a Cook 36×80-mm Zenith Dissection Endovascular System (ZDES) bare metal stent was used on a compassionate basis to append the embolized valve between the patient's coronary artery ostia and the innominate artery takeoff within the ascending aorta, with no neurological or cardiovascular complications at 12-month follow-up. CONCLUSION: A Cook ZDES bare metal stent may be successfully used to append an embolized Edwards SAPIEN XT valve within the ascending aorta.

Dealing With a Nightmare: A Case Report of Successful Percutaneous Treatment of an Embolized Occluder Device Complicating a Minimal-Fluoroscopy Patent Ductus Arteriosus Closure.

Patent ductus arteriosus (PDA) is one of the most prevalent acyanotic congenital heart diseases. Percutaneous closure of PDA has been the preferred treatment recommended by the guidelines due to relatively low complications and rapid patient recovery. However, device emboli remain the most frequent and disastrous complication, necessitating percutaneous or surgical treatment. We present a case of a large PDA closure in pulmonary arterial hypertension paediatric patients complicated with device emboli that was successfully retrieved using the snaring technique. Transcatheter retrieval, although technically challenging, is a feasible treatment and offers the advantage of avoiding the need for surgical intervention.

Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Endovascular retrieval of left atrial appendage closure device embolized to the aorta.

Patients with atrial fibrillation with contraindications to anticoagulation can undergo left atrial appendage closure with a device. Hours after a 73-year-old man had undergone left atrial appendage closure, he lost perfusion to his lower extremities. Imaging studies showed that the device had migrated to the infrarenal aorta. After right common femoral artery cutdown and sheath placement, the device was retrieved with a balloon embolectomy catheter, and a balloon was simultaneously deployed in the proximal left common femoral artery to prevent device embolization. To the best of our knowledge, this report represents the first documented device retrieval from the aorta using balloon embolectomy and contralateral lower extremity embolic protection.

Atrial septal defect occluder device embolization: Experience of a tertiary care cardiac center.

Background: Percutaneous device closure of atrial septal defect (ASD) has become an increasingly popular procedure as it offers several advantages. However, it is associated with infrequent, but life-threatening complications such as device embolization. Objective: To analyze the risk factors, common sites of embolization, associated complications, timing of embolization, and the treatment executed. Settings and Design: A retrospective study was performed at a tertiary referral center for cardiac services. Material and Methods: Pre-procedure, intra-procedure, and post-procedure data of patients whose ASD device embolized was collected retrospectively and analyzed for risk factors, common sites of embolization, associated complications, timing of embolization, and the treatment executed. Results: Thirty devices were embolized, out of which 13 were retrieved percutaneously in the Catheter laboratory, whereas 17 patients underwent surgery. Fourteen patients had an unfavorable septal morphology for device closure. Ten devices were embolized in the catheter laboratory, five in the intensive care unit, and two in the ward. The devices were embolized to almost all chambers of the heart and great vessels. One patient had an inferior vena cava rim tear while attempting percutaneous retrieval. One patient required a short period of total circulatory arrest (TCA) for retrieval of the device from ascending aorta, while another required a lateral position for retrieval from descending aorta. One patient required re-exploration for bleeding, while another had an air embolism and succumbed. Conclusions: Once embolization occurs, the risks associated increase manifold. Most of the surgical extractions are uneventful; however, there could be certain complications that may need repair of valvular apparatus, the institution of TCA, or the need for the lateral position. Air embolization though very rare can occur which could be fatal.

Left Atrial Appendage Closure Device Embolization under the Anterior Leaflet of Mitral Valve: Echocardiographic Diagnosis and Management.

A 76-year-old man with history of previous coronary artery bypass grafting, permanent atrial fibrillation in novel oral anticoagulation therapy, and gastrointestinal bleedings underwent percutaneous left atrial appendage closure. The procedure was complicated by intraoperative device embolization, which caused a dynamic obstruction of the left ventricular outflow tract leading to severe hemodynamic instability. Transesophageal echocardiography showed a device in the ventricle site of the mitral anterior leaflet. The coronary angiography showed also patency of both arterial grafts in stable coronary artery disease. After failing the percutaneous retrieval with a snare, emergent surgery was planned. A moderate calcified aortic valve stenosis was also found, but in consideration of the unstable clinical conditions of the patient, we thought of performing a transcatheter aortic valve replacement (TAVR) in a second time. We have carefully planned the surgical retrieval of the device embolized paying attention of his several comorbidities. The strategy to remove the device with cardiopulmonary bypass without cross-clamping the aorta through a right mini-thoracotomy has been preferred.

A valve embolized twice: a case report of Sapien 3 embolization in left ventricle and left atrium during transcatheter transapical mitral valve-in-valve implantations for a failed bioprosthesis.

Background: Transcatheter mitral valve-in-valve (TMVIV) using the Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) transcatheter heart valve is associated with high technical success and sustained valve performance. However, complications may occur or be detected during or after the procedure. Case summary: We herein describe a rare case of a 59-year-old female who underwent TMVIV for a failed surgical mitral bioprosthesis. During the procedure, the device was embolized twice into the left ventricle and left atrium, respectively, resulting from the crimped transcatheter valve partially detaching from the balloon of the Certitude delivery system during passage through a tight transapical sheath. Fortunately, we were able to catch the dislodged valve and anchor it by the partially inflated device balloon, followed by successful repositioning and deployment. Discussion: In cases where the valve has already detached, as in the present case, the sheath may be advanced against the proximal end of the valve as a pusher, providing good support to push the entire system to cross the bioprosthesis. Then, the delivery catheter should be withdrawn with the counteraction of the sheath in order to correct the interrelated positions of the valve and the balloon. Finally, the valve can be positioned and deployed after the sheath is withdrawn.

Complications of trans-catheter closure of atrial septal defects.

Trans-catheter device closure of atrial septal defects (ASD) is considered to be safe with minimal complications. But, there are certain complications that arise after these device closures which might require urgent or late surgical intervention. We have retrospectively analysed our experience. Out of 780 patients who underwent device closure, 11 (1.4%) patients required urgent surgical intervention to retrieve the embolized device. The size of the ASD, expertise of the cardiologist and the type of the device directly impacted the rate of device embolization. Early diagnosis and prompt surgical retrieval is paramount before any life threatening complications arise due to the embolized device. One patient developed infective endocarditis later, which required surgery. Regular long term follow up is needed after these procedures to diagnose the complications earlier so that prompt surgical intervention could be done.

Management of Coronary Complications.

Coronary complications are increasingly rare but remain fatal if not managed promptly and effectively. We review the incidence, management, and prevention of the most serious coronary complications including acute vessel closure from dissection, no-reflow, thrombosis, and air embolism as well as mechanical complications including perforation, stent dislodgment, and atherectomy burr entrapment.

Hybrid retrieval of embolized device in abdominal aorta after transcatheter closure of large patent ductus arteriosus.

Patients with a large patent ductus arteriosus (PDA) can have several presentations. Many will be asymptomatic, some could develop severe pulmonary hypertension, and others can develop Eisenmenger syndrome. We have presented a case in which a PDA correction device was embolized to the abdominal aorta, 2 months after transcatheter closure of a large PDA. The patient presented with an acute abdomen. In the management of the case, we implemented a hybrid technique in the process of device retrieval. Transbrachial access and a lower abdominal midline incision were accomplished to dislodge the device from the supraceliac aorta to the aortic bifurcation. The Amplatzer Ductal Occluder (St Jude Medical Inc, St Paul, Minn) was extracted through a small arteriotomy of the distal abdominal aorta. The procedure was followed by a dramatic improvement of the ischemic liver and bowel, evidenced by the vanishing of the cyanotic hue of the liver and normalization of the bluish discoloration of the intestine.

Lost but Not Lost-Embolization of a Leadless Pacemaker to the Pulmonary Artery with Consecutive Endovascular Recovery.

BACKGROUND: Leadless transcatheter pacemaker systems (TPS) have become a valuable alternative to transvenous pacemakers in selected indications. With the steadily increasing amount of TPS implantations performed worldwide, reports of periprocedural complications are likewise increasingly found in the literature but are still underreported. CASE PRESENTATION: We report a case of a 75 year old male undergoing TPS implantation due to cardioinhibitory vasovagal syncope. The implantation was primarily uneventful; adequate pacing parameters and fixation of the device were achieved. Unfortunately, dislocation of the leadless pacemaker occurred at the end of the procedure and the device embolized into a primary side branch of the right pulmonary artery. Endovascular retrieval was performed by using a single snare technique without any further complications. CONCLUSIONS: Although challenging, endovascular recovery of embolized TPS from the pulmonary artery is feasible and may be successfully accomplished by experienced implanters.

Retrieval and repositioning of an embolized atrial septal defect closure device using a gooseneck snare.

BACKGROUND: Closure of all haemodynamically significant atrial septal defects (ASDs) is recommended irrespective of symptoms. Percutaneous device closure offers a favourable alternative to surgery with lower morbidity, shorter duration of hospital stays, and avoidance of a surgical scar. Though device closure is generally a safe procedure with high success rates, certain complications can arise including device embolization which poses a significant challenge for the treating team. We report one such case in which the ASD closure device got spontaneously released and embolized from the delivery cable into the left atrium prior to its deployment. We describe our approach for its retrieval and subsequently its successful deployment across the septal defect using a gooseneck snare. CASE PRESENTATION: A 5-year-old asymptomatic child was found to have a murmur on a routine check-up. Evaluation revealed a haemodynamically significant, 18-mm ostium secundum ASD with normal pulmonary pressures and suitable margins for device closure. A 20-mm ASD closure device was traversed via an 8-Fr delivery system. While manipulating the left atrial (LA) disc from the right upper pulmonary vein (RUPV) approach, the device got spontaneously released. The right atrial (RA) disc was caught across the ASD, into the left atrium. This was confirmed by intraoperative transthoracic echocardiography and fluoroscopy. The haemodynamics and rhythm were stable. A 20-mm gooseneck snare was immediately passed through the delivery sheath and an attempt was made to catch the screw. With difficulty, the RA screw was caught with the snare and multiple attempts to retrieve the device into the sheath were unsuccessful. However, while negotiating, we were able to secure a favourable position of the device across the atrial septal defect, and after fluoroscopic and echocardiographic confirmation, the device was released. The child remained stable thereafter and was discharged 2 days later. CONCLUSIONS: Gooseneck snare is a valuable tool in the management of embolized ASD closure device. Occasionally, like in the index case, one may be successful in retrieving the embolized device and repositioning it across the ASD using a gooseneck snare, thus obviating the need for emergency surgery.

Patent Ductus Arteriosus Device Closure in Interrupted Inferior Vena Cava: Challenges Overcome and Lessons Learnt: A Case Series.

Interrupted inferior vena cava (IVC) with azygous continuation provides technical challenge in many percutaneous cardiac interventions. They are performed via the femoral venous access route. We describe four such cases in whom, patent ductus arteriosus (PDA) device closure was done in interrupted IVC. All the four cases were done using the femoral route. Two cases were done via retrograde approach through femoral artery access, in which one was closed with a muscular VSD device and the other with a Gianturco coil. The introduction of newer closure devices helps in the retrograde approach. Two cases were done via anterograde approach through the femoral venous route, with a loop through the azygous vein. One child had transient bradycardia due to cardiac stretch which normalized after the device deployment and introducer system removal. Thus, we describe different femoral approaches in interrupted IVC patients for PDA closure, with the difficulties faced and the complications managed.

Left atrial appendage closure in patients with prohibitive anatomy: Insights from PINNACLE FLX.

BACKGROUND: Watchman 2.5 (Boston Scientific Inc, Marlborough, MA) implant success approaches 95% in registries, yet many patients are not attempted because of complex left atrial appendage (LAA) anatomy. Watchman FLX can expand the range of ostium width (14-31.5 mm) and depth available for LAA closure. OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of Watchman FLX in patients with a failed Watchman 2.5 attempt or prohibitive LAA anatomy. METHODS: The roll-in (n = 58) and primary effectiveness (n = 400) cohorts of the PINNACLE FLX trial comprised the study population. Subjects were identified who previously failed implantation of Watchman 2.5 (n = 11) or were not attempted because of prohibitive LAA anatomy (n = 88). Demographic characteristics, implant procedure details, and TEE follow-up data were compared to controls composed of enrollees not meeting these criteria (n = 359). RESULTS: Watchman FLX LAA closure was successfully implanted in all subjects with a prior failed Watchman 2.5 attempt (n = 11 of 11). Subjects with previously failed Watchman 2.5 were more likely to receive a 35 mm FLX device than controls (27.3% vs 7.3%; P = .047). Patients with prohibitive anatomy had smaller LAA dimensions than did controls (diameter 18.0 ± 4 mm vs 20.4 ± 3 mm; P < .001 and length 23.7 ± 5 mm vs 28.9 ± 5 mm; P < .001). There was no difference in age, sex, CHA2DS2-VASc score, HAS-BLED score, or primary efficacy between cohorts. Transesophageal echocardiography (TEE) at 12 months showed zero leak in 90.9% in the failed Watchman 2.5 cohort, 91.3% in the prohibitive anatomy cohort, and 89.5% in the control cohort (P = .84). Overall and cardiovascular mortality was lower in the prohibitive anatomy cohort (1.2% vs 8.8% in controls; P = .02). CONCLUSION: Watchman FLX implantation in patients with a prior failed Watchman 2.5 attempt or prohibitive LAA anatomy remained safe and highly effective. The association of reduced overall mortality with smaller LAA dimension warrants future study.