Interventional closure of an iatrogenic LAA-perforation by means of a PFO-occluder.

Atrial fibrillation (AF) is the most common rhythm disorder with a high risk for cardioembolic strokes. Interventional occlusion of the left atrial appendage (LAA) is an alternative to the widely established stroke prevention with oral anticoagulation. Complications through LAA closure (LAAC) are rare and usually occur periinterventional. We present a case of an 87-year-old patient who presents for elective LAAC. After placement of the LAA occluder (Amplatzer Amulet device 25 mm) in the LAA and partial resheathing, the patient developed a pericardial effusion (PE), became hemodynamically unstable and went into cardiac arrest with the need for cardiopulmonary resuscitation (CPR). After drainage of the PE, we closed the causative LAA-perforation using a persistent foramen ovale (PFO)-occluder device (Amplatzer Talisman, 25 mm). Thereby we were able to successfully seal the perforation and stabilize the patient. The patient was monitored at our intensive care unit for 2 days and left the hospital in good condition a few days after. Procedural complications during interventional LAAC are rare but can be serious. The most common complication, PE, requires percutaneous drainage and often cardiac surgery. We present a case in which a perforation and following PE with hemodynamic relevance and need for CPR was resolved with an interventional strategy through implantation of a PFO-occluder into the perforation. With this approach we were able to show that in the right setting even serious complications can be treated by interventional measures, thereby not only saving the patient's life, but also avoiding cardiac surgery.

Prognostic Value of Galectin-3 after Left Atrial Appendage Occlusion for Predicting Peri-Device Leakage.

Echocardiographic detection of residual peri-device leakage (PDL) after percutaneous left atrial appendage occlusion (LAAO) is crucial for managing anticoagulation. Galectin-3, a protein involved in tissue-foreign body interactions, may hold significance in understanding PDL and cardiac tissue remodeling after LAAO. This study aimed to analyze galectin-3 serum levels in relation to PDL using a novel echo-morphological classification. LAAO eligible patients were included in the study. Galectin-3 serum levels were measured before LAAO, at 45 days (45D), and at 6 months (6M) after the procedure. Transesophageal echocardiography was used to assess LAAO success. A new echo-morphological classification categorized the degree of LAAO into three different types (A: homogenous echodensity, indicating completely thrombosed device; B: inhomogeneous echolucencies (<50% of device); and C: partially thrombosed device with echolucencies > 50%). Among 47 patients, complete LAAO was achieved in 60% after 45D and in 74% after 6M. We observed a significant increase and distribution of serum levels of galectin-3 [ng/mL] after 45D among the three types (baseline: 13.1 ± 5.8 ng/mL; 45D: 16.3 ± 7.2 ng/mL (Type A) vs. 19.2 ± 8.6 ng/mL (Type B) vs. 25.8 ± 9.4 ng/mL (Type C); p = 0.031), followed by a drop in galectin-3 for Types A and B after 6M toward and below the baseline levels (6M: 8.9 ± 3.1 ng/mL (Type A) vs. 12.4 ± 5.5 ng/mL (Type B)), whereas Type C persisted in showing elevated galectin-3 levels compared to all other types (6M: 17.5 ± 4.5 ng/mL (Type C); p < 0.01). Increased galectin-3 serum levels after LAAO likely reflect the transition from thrombus formation to fibrotic scar development in the LAA lumen. Successful occlusion is associated with a time-restricted decrease in galectin-3 levels after 6 months, while relevant PDL leads to persistently elevated levels, making galectin-3 a potential predictor of occlusion success.

Feasibility of percutaneous left atrial appendage closure using a novel LAmbre occluder in patients with atrial fibrillation: Initial results from a prospective cohort registry study.

BACKGROUND: The LAmbre™ occluder is a novel device for percutaneous left atrial appendage closure (LAAC). The presented study aimed to report the initial experience in implantation of the novel LAmbre for LAAC in patients with nonvalvular AF. METHODS: We conducted a prospective, observational, cohort registry study to evaluate the feasibility of percutaneous LAAC using the LAmbre system. RESULTS: Thirty patients (15 female, mean age 77.6 ± 8.9 years) who had high risks of stroke and contraindications for oral anticoagulation were prospectively enrolled in this registry study. The mean CHA2DS2-VaSc was 3.9 ± 1.5, and the mean HAS-BLED score was 4.1 ± 1.0. Twenty (66.7%) patients had chicken-wing LAA morphology. The implant success rate was 100%. The mean fluoroscopic time and procedure time were 3.5 ± 1.9 and 29.0 ± 10.1 minutes, respectively. No significant procedure-related complications were observed during in-hospital and acute clinical follow-up. CONCLUSION: In this preliminary study, the LAmbre occluder showed an excellent implant success rate, favorable implant property, and very low incidence of complications. Larger sample, randomized studies are further warranted.

--LAA Occluder View for post-implantation Evaluation (LOVE)--standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography.

BACKGROUND: A standardized imaging proposal evaluating implanted left atrial appendage (LAA) occlusion devices by cardiac computed tomography angiography (cCTA) has never been investigated. METHODS: cCTA datasets were acquired on a 3(rd) generation dual-source CT system and reconstructed with a slice thickness of 0.5 mm. An interdisciplinary evaluation was performed by two interventional cardiologists and one radiologist on a 3D multi-planar workstation. A standardized multi-planar reconstruction algorithm was developed in order to assess relevant clinical aspects of implanted LAA occlusion devices being outlined within a pictorial essay. RESULTS: The following clinical aspects of implanted LAA occlusion devices were evaluated within the most appropriate cCTA multi-planar reconstruction: (1) topography to neighboring structures, (2) peri-device leaks, (3) coverage of LAA lobes, (4) indirect signs of neo-endothelialization. These are illustrated within concise CT imaging examples emphasizing the potential value of the proposed cCTA imaging algorithm: Starting from anatomical cCTA planes and stepwise angulation planes perpendicular to the base of the LAA devices generates an optimal LAA Occluder View for post-implantation Evaluation (LOVE). Aligned true axial, sagittal and coronal LOVE planes offer a standardized and detailed evaluation of LAA occlusion devices after percutaneous implantation. CONCLUSIONS: This pictorial essay presents a standardized imaging proposal by cCTA using multi-planar reconstructions that enables systematical follow-up and comparison of patients after LAA occlusion device implantation.

Left Atrial Appendage Occlusion Strengths and Weaknesses of the Lobe-Only Occluder Concept in Theory and in Practice.

Left atrial appendage closure aims to eliminate the stasis component of Virchow triad by eliminating a cul-de-sac that favors thrombosis, particularly when atrial contractility becomes inefficient, such as in atrial fibrillation. Left atrial appendage closure devices have a common objective of sealing the appendage completely, with device stability and avoidance of device thrombosis. Two main device designs have been used to perform left atrial appendage closure: those that use a pacifier design (lobe + disk) and those that use a plug (single lobe) design. This review highlights the potential features and benefits of the single-lobe devices.

Left Atrial Appendage Occlusion Strengths and Weaknesses of the Lobe-Only Occluder Concept in Theory and in Practice.

Left atrial appendage closure aims to eliminate the stasis component of Virchow triad by eliminating a cul-de-sac that favors thrombosis, particularly when atrial contractility becomes inefficient, such as in atrial fibrillation. Left atrial appendage closure devices have a common objective of sealing the appendage completely, with device stability and avoidance of device thrombosis. Two main device designs have been used to perform left atrial appendage closure: those that use a pacifier design (lobe + disk) and those that use a plug (single lobe) design. This review highlights the potential features and benefits of the single-lobe devices.

Antiplatelet effects of aspirin and clopidogrel after left atrial appendage (LAA) occluder implantation.

BACKGROUND: The optimal antithrombotic strategy after interventional left atrial appendage closure (LAAC) is controversial. Dual antiplatelet therapy with aspirin and clopidogrel is the most frequently used regiment. However, pharmacodynamic response to antiplatelet medication differs significantly between individuals. Therefore, we aimed to analyse pharmacodynamic response to aspirin and clopidogrel after LAAC. METHODS: In this study, we included 129 patients undergoing interventional LAAC. Primary end point was pharmacodynamic response to antiplatelet medication. Platelet reactivity was measured by light transmittance aggregometry and vasodilator stimulated protein phosphorylation assay. Secondary endpoints were TIMI bleeding events and MACCE during hospital course and one-year follow-up. RESULTS: Insufficient pharmacodynamic response (high on-treatment platelet reactivity - HTPR) to clopidogrel occurred in 67 patients (52%); HTPR to aspirin in 15 patients (12%); low on-treatment platelet reactivity - LTPR - to clopidogrel in 13 patients (10%). No occluder thrombosis or stroke occurred during one year follow-up. Pharmacodynamic response to antiplatelet medication was not associated with MACCE. However, the incidence of TIMI minor bleeding was increased in patients with LTPR to clopidogrel. CONCLUSIONS: Impaired clopidogrel antiplatelet effects were very frequent in patients after LAAC. No stroke or occluder thrombosis occurred. Patients with LTPR to clopidogrel showed more minor bleeding events. Therefore, this hypothesis generating pilot study raises the question if clopidogrel early after LAAC is needed. This question should be addressed in large scale trials.

A case report of a late left atrial appendage perforation 4 months after occluder implant: reason for or caused by a resuscitation?

BACKGROUND: Atrial fibrillation (AF) is a common disease and can lead to cardioembolic stroke. Stroke prevention according to the CHA2DS2VASc score is achieved via oral anticoagulation. In recent years, interventional occlusion of the left atrial appendage (LAA) has become a common alternative. Besides showing non-inferiority in large trials compared with warfarin interventional LAA occlusion can lead to serious adverse events with most of them occurring peri-interventionally. CASE SUMMARY: A 75-year-old man with AF and recurrent gastrointestinal bleedings was referred for an interventional closure of the LAA. The intervention was successful with an ABBOTT® Amulet device. Four months later, the patient had to be resuscitated. Return of spontaneous circulation occurred after 10 min. On hospital arrival, echocardiography revealed a pericardial tamponade and 2 L of blood were drained. A coronary angiogram revealed a lesion with active leakage of contrast agent in the proximal circumflex artery. The patient was transferred to the cardiac surgery department immediately. Intra-operatively a perforation of the tissue at the basis of the LAA close to the left main coronary artery was discovered. The occluder was excised and the LAA was closed by endocardial sutures. DISCUSSION: In this report, we review the literature concerning interventional LAA occlusion and the reported cases of LAA perforation. Retrospectively, it remains unclear whether the perforation caused the resuscitation or was induced by it. To our knowledge, this is the first reported case of a laceration of a coronary artery by an occlusion device.

Cardiac CT Angiography (CCTA) predicts left atrial appendage occluder device size and procedure outcome.

AIM: To investigate the role of cardiac CT angiography (CCTA) in predicting optimal left atrial appendage (LAA) occluder size and procedure outcome. METHODS AND RESULTS: Thirty-six patients underwent pre-procedural CCTA. CCTA and TEE LAA orifice diameters and perimeters were compared with the implanted device size. CCTA 3D configuration was correlated with procedure outcome. Watchman™ device (N = 18): diameters were 21 ± 4, 26 ± 5 and 25 ± 3 mm for TEE, CCTA and inserted device, respectively. Average perimeters were 61 ± 10, 74 ± 8 and 78 ± 11 mm for TEE, CCTA and inserted device, respectively. Better agreement with the device size was found for CCTA compared to TEE (Bland-Altman). ACP™ device (N = 15): diameters were 20 ± 5, 25 ± 4 and 23 ± 4 for TEE, CCTA and inserted device, respectively. Average perimeters were 58 ± 11, 72 ± 15 and 72 ± 13 mm for TEE, CCTA and inserted device, respectively. Excellent correlation and agreement with the device size was found for CCTA compared to TEE. CCTA perimeter >100 mm and "cactus" 3D configuration had a specificity of 96 and 81% respectively for procedure failure. CONCLUSIONS: CCTA LAA ostial perimeter predicted better the optimal occluder size as compared with the currently used LAA TEE diameter. Moreover, CCTA 3D data may help in predicting potential complications.

LAA occluder device for stroke prevention: Data on WATCHMAN and other LAA occluders.

NOAC therapy has become the standard for stroke prevention in patients with atrial fibrillation. Yet some patients suffer extracranial bleeding events or have other reasons to seek non-pharmacologic stroke protection. LAA occlusion with the WATCHMAN device has been proven safe and effective for such patients and is now recommended in current guidelines for this patient group; other devices also seek approval.

Percutaneous left atrial appendage closure with a novel self-modelizing device: a pre-clinical feasibility study.

The aim of the study is to evaluate the feasibility and safety of a new left atrial appendage (LAA) occluder. Twelve pigs were included. In 2 pigs the implantation process failed due to pericardial tamponade in 1 pig and device embolization in the other pig. The placement of the devices was controlled via TEE and fluoroscopy. After 6 weeks of implantation the hearts were explanted. The devices were found to be easy to deploy and showed a very good adaptation to the LAA tissue. Eight out of 10 pigs had full closure of the LAA directly after implantation. After six weeks, due to the self-modelizing properties of the device, all pigs had a full closure of the LAA. The macroscopic evaluation of the explanted hearts showed that all devices were securely integrated in LAA tissues. There was one case of mild pericarditis but no macroscopic signs of inflammation on the device surrounding endocardium. The explantation revealed that device loops had penetrated the LAA tissue in three pigs. However, no signs of bleeding, pericardial effusion, or other damage to the LAA wall could be detected and the pigs were in good condition with normal weight gain and no clinical symptoms. The Occlutech® LAA occluder achieved complete closure of the LAA in all pigs, and remained in the LAA, with benign healing and no evidence of new thrombus or damage to surrounding structures. Moreover, the uncompromised survival of all implanted pigs demonstrates the feasibility and safety of the device.