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Author's summary We sought to determine neurological outcomes following stroke in patients with left atrial appendage occlusion (LAAO) or non-vitamin K antagonist oral anticoagulant (NOAC) treatment for non-valvular atrial fibrillation (NVAF). Left atrial appendage closure significantly reduced stroke severity and lowered the risk of disabling stroke at 12 months post-event compared to NOAC after adjusting for multiple demographic and cardiovascular risk factors (odds ratio, 0.23; 95% confidence interval, 0.07–0.71; p=0.01). Thus, LAAO may yield more favorable outcomes in NVAF patients experiencing subsequent stroke than NOAC treatment, even in patients with increased risk of cardio- and cerebrovascular events., Background and Objectives Prior studies have shown that stroke patients treated with percutaneous left atrial appendage occlusion (LAAO) for non-valvular atrial fibrillation (NVAF) experience better outcomes than similar patients treated with warfarin. We investigated the impact of percutaneous left atrial appendage closure on post-stroke neurological outcomes in NVAF patients, compared with non-vitamin K antagonist oral anticoagulant (NOAC) therapy. Methods Medical records for 1,427 patients in multiple registries and for 1,792 consecutive patients at 6 Korean hospitals were reviewed with respect to LAAO or NOAC treatment. Stroke severity in patients who experienced ischemic stroke or transient ischemic attack after either treatment was assessed with modified Rankin Scale (mRS) scoring at hospital discharge and at 3 and 12 months post-stroke. Results mRS scores were significantly lower in LAAO patients at 3 (p

Visual Abstract, Highlights • Surgical myectomy is morbid and transcoronary alcohol septal ablation can result in geographic miss or occasional nontarget injury. • We developed a transvenous intraseptal radiofrequency ablation technique (cerclage ablation method) to overcome the shortcomings of surgical myectomy and alcohol septal ablation. • We delivered dedicated intraseptal radiofrequency ablation catheter into the ventricular septum through the coronary sinus and a septal vein. The ablated volume of myocardium was larger at higher electrode temperatures and using an irrigated-ablation mode in vitro. Cerclage ablation was successful in all in vivo attempts and induced a focal regional wall motion abnormality at later follow-up. • This study presents in vivo evidence of the feasibility, effectiveness, and safety of cerclage ablation method to debulk interventricular septal myocardium., Summary Debulking of left ventricular septal mass is typically accomplished using surgical myectomy, which is morbid, or using transcoronary alcohol septal ablation, which can result in geographic miss and occasional catastrophic nontarget coronary injury. The authors developed and tested operational parameters in vitro and vivo for a device to accomplish transvenous intraseptal radiofrequency ablation to reduce ventricular septal mass using a technique derived from mitral cerclage, which the authors call cerclage ablation. Cerclage ablation appeared feasible in vitro and safe and effective in vivo. Cerclage ablation is an attractive new approach to debulk the interventricular septum in obstructive hypertrophic cardiomyopathy. These data support clinical investigation.

Resumen Introduccion y objetivos A pesar de la eficacia de los anticoagulantes orales (ACO), algunos pacientes mantienen una alto riesgo residual y presentan ictus aun estando en tratamiento con ACO, y falta evidencia sobre el tratamiento de estos pacientes. El objetivo del estudio es analizar la seguridad y la eficacia del cierre percutaneo de la orejuela izquierda (OI) como prevencion secundaria para pacientes con fibrilacion auricular no valvular que han experimentado un ictus/accidente isquemico transitorio a pesar de los ACO (ictus resistente [IR]). Metodos Se estudio a 1.047 pacientes consecutivos con fibrilacion auricular no valvular sometidos a cierre percutaneo de la OI incluidos en el registro multicentrico Amplatzer Cardiac Plug. Se selecciono a los pacientes con IR como indicacion para el cierre de la OI, y se los comparo con pacientes con otras indicaciones. Resultados En un total de 115 pacientes (11%) se produjo un IR. Las escalas CHA2DS2-VASc y HAS-BLED eran significativamente mas altas en el grupo de IR (5,5 ± 1,5 frente a 4,3 ± 1,6; p Conclusiones Los pacientes con IR sometidos a cierre percutaneo de la OI presentaron resultados de seguridad similares que los pacientes sin IR, con una reduccion significativa de los eventos de ictus/accidente isquemico transitorio y hemorragia mayor durante el seguimiento.

INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5±1.5 vs 4.3±1.6; P

Hyperlipidemic heart transplant patients who develop cardiac allograft vasculopathy (CAV) benefit from HELP-apheresis (Heparin-induced Extracorporeal LDL Precipitation) which enables drastic lowering of plasma low-density lipoprotein, lipoprotein (a), and fibrinogen. There is evidence that HELP-apheresis also improves microcirculation by an immediate improvement of impaired endothelial-dependent vasodilatation and additive hemorheological effects.Therefore, cutaneous microcirculation was examined before, during, and after the first HELP-apheresis in eight hyperlipidemic cardiac transplant recipients with CAV. To study the long-term effect the intravital microscopy was repeated after three and 12 months of weekly apheresis treatment.In CAV patients the baseline mean erythrocyte velocity was pathologically reduced with 0.13±0.07 mm/s. During the first HELP-apheresis the erythrocyte velocity increased significantly (p = 0.0001) and remained increased until the end of the HELP procedure (p

OBJECTIVES This study sought to investigate neurological disability after ischemic cerebrovascular events in patients treated with left atrial appendage (LAA) occlusion compared with those on warfarin. BACKGROUND Prior studies demonstrated that cerebrovascular events after LAA occlusion in patients with nonvalvular atrial fibrillation (NVAF) is largely nondisabling. METHODS From the 1,189 patients in the Korean LAA Occlusion and European Amplatzer Cardiac Plug Multi-Center Registry, 24 patients who experienced ischemic cerebrovascular events after LAA occlusion were enrolled. The neurological outcomes were compared with those in 68 patients who experienced an ischemic cerebrovascular event while on warfarin (Yonsei Stroke Registry). A modified Rankin scale (mRS) score of 3-6 categorized the cerebrovascular event as disabling. The mRS at discharge and at 3 and 12 months postcerebrovascular event in the two groups was compared. RESULTS The percentages of disabling cerebrovascular events were 37.5% and 58.8% at discharge (P = 0.07), 20.8% and 42.6% at 3 months (P = 0.08), and 12.5% and 39.7% at 12 months (P = 0.02) in the LAA occlusion and warfarin groups, respectively. The mRS was significantly lower in the LAA occlusion group at discharge and at 3 months (P

Background Due the wide variability of left atrial appendage morphology left atrial appendage occlusion (LAAO) remains a challenging procedure. The steerable FuStar delivery sheath was designed to allow both, transseptal access and delivery of percutaneous devices. We here report the first-in-human experience of LAAO with the FuStar sheath. Methods Twenty patients (76.6 ± 8.4 years; 12 (60%) males; CHA2 DS2 -VASc score: 5.0 ± 2) with non-valvular fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath (Lifetech Scientific Corp., Shenzhen, China) at two german centers. Results Successful device implantation was achieved in all patients (100%). No periprocedural complications were observed. Procedure time, fluoroscopy time, contrast media, and radiation dose were 23.4 min ± 9.2, 11.9 min ± 4.1, 96.2 mL ± 45.7, and 2718.4 cG*cm2 ± 3835.3, respectively. Conclusion This study demonstrates the feasibility and safety of the steerable FuStar sheath for LAAO.

Introduction The LAmbre (LifeTech Scientific, Shenzhen, China) is a novel occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation. This study compares late clinical outcomes of LAmbre and the established Amplatzer devices (Abbott, St Paul, MN). Methods Between 2012 and 2018, 265 consecutive patients underwent LAAC with LAmbre and Amplatzer devices at a single center. After a 3:1 propensity score matching, 40 (LAmbre) vs 107 (Amplatzer) patients were compared by the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major periprocedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all the above-mentioned hazards. Results The mean age 75.6 ± 8.9 (LAmbre) vs 75.5 ± 9.0 (Amplatzer) years, CHA2 DS2 -VASc score 4.8 ± 1.7 vs 4.8 ± 1.7 and HAS-BLED score 3.1 ± 0.9 vs 3.2 ± 0.8 were similar. After 3.6 ± 1.9 vs 2.5 ± 1.4 years, the clinical efficacy (12/146, 8.2% [LAmbre] vs 28/266, 10.5% [Amplatzer]; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.38-1.40; P = .34) and safety (5/146, 3.4% vs 14/266, 5.3%; HR, 0.47; 95% CI, 0.14-1.6; P = .22), as well as the combined hazard endpoint (15/146, 10.3% vs 36/266, 13.6%; HR, 0.67; 95% CI, 0.36-1.25; P = .21) were comparable. Conclusion In the presented report, in patients with nonvalvular atrial fibrillation, the LAmbre offered similar long-term efficacy and safety in comparison to Amplatzer devices.

OBJECTIVES To compare long-term clinical outcomes after left atrial appendage closure with the Amplatzer Cardiac Plug (ACP) and Amulet. BACKGROUND The Amulet was designed to improve clinical outcomes of first-generation ACP. METHODS Three Amplatzer registries (Bern, Coburg, Zurich), with enrollment of patients from 2009 to 2018, were retrospectively analyzed. The primary safety endpoint was a composite of major peri-procedural complications and major bleedings, the primary efficacy endpoint included stroke, systemic embolism, and cardiovascular/unexplained death. The net clinical benefit was a combination of all above-mentioned hazards. RESULTS A total of consecutive 563 patients (344 ACP vs. 219 Amulet) with a mean follow-up of 2.9 ± 1.6 and 1.9 ± 0.9 years were included. Mean age (74.4 ± 9.9 [ACP] vs. 74.4 ± 9.1 [Amulet] years), stroke (CHA2 DS2 -VASc score 4.4 ± 1.6 vs. 4.6 ± 1.7), and bleeding risk (HAS-BLED score 3.2 ± 1.1 vs. 3.2 ± 0.9) were comparable. The primary endpoints of efficacy (72/998, 7.2% [ACP] vs. 43/417, 10.3% [Amulet]; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.44-1.02, p = .062), safety (40/998, 4.0% vs. 18/417, 4.3%; HR, 1.15; 95% CI, 0.53-2.51, p = .72), and the net clinical benefit (101/998, 10.1% vs. 55/417, 13.4%; HR, 0.73; 95% CI, 0.49-1.07, p = .11) were similar. CONCLUSION In the long term, left atrial appendage closure with first and second-generation Amplatzer devices provided similar efficacy, safety, and net clinical benefit. Clinical outcomes may be rather determined by implantation technique and hemodynamics, but not by the design modifications of the Amulet.

Background Thousands of patients present themselves annually to the emergency department or private clinic with chest pain. Categorizing different types of angina is clinically important and is one of the cornerstones for pre-test-probability. In patients with angina pectoris, symptoms mostly occurred during physical exertion and usually lasted a short time. This paper examines Magnetocardiography (MCG) in patients with angina pectoris. Cardiac electromagnetic activity is recorded by MCG which is a non-invasive, non-contact, and radiation-free multichannel mapping technique. We present results focusing on resting- and stress-MCG in order to detect true coronary artery disease. Method We examined 131 patients (66±12 yrs., 94 male) with angina pectoris who were asymptomatic during the time in the emergency department. Troponin and ECG were in normal range. These patients had complex cardiovascular risk factors – arterial hypertension in 87%, hyperliproteinemia in 63%, nicotine consumption in 23%, diabetes mellitus in 14%. The cardiac magnetic field was registered over the anterior chest wall with a 64-channel gradiometer system in a magnetically shielded room (CS-MAG III, BMP GmbH). Rest- and Stress-MCG measurement were performed before patients received an invasive ischemia investigation. We calculated in total 9 MCG parameters that could serve as indicators in the diagnosis of ischemia and coronary artery disease (CAD): T-wave dispersion, T-wave vectors MCG (VMCG), T-Scores, ST-Fluc-Score and PLP-Score. Results All of the 131 patients received an invasive diagnostic. 43 patients exhibited a CAD. Resting MCG could identify 28/43 patients correctly (SENS of 65%, NPV of 66%). Stress-MCG was able to identify 42/43 correctly (SENS 98%, NPV 88%). Conclusions Stress-MCG seems to be a highly sensitive method in detecting CAD in patients with stable angina. In diagnostics, it should be complemented by other indicators such as troponin to improve its specificity.

Magnetocardiography (MCG) has been proposed as a non-invasive and functional technique with high accuracy for diagnosis of myocardial ischemia. This study sought to investigate the incremental diagnostic value of combined quantitative and qualitative parameters of MCG to detect coronary artery disease (CAD).Ninety six patients with suspected CAD who underwent coronary angiography were enrolled in the analysis to test the diagnostic accuracy of 2 MCG parameters (a quantitative parameter of the percent change of ST-segment fluctuation score and a qualitative parameter of non-dipole phenomenon).The best cut-off value for the percent change of ST-segment fluctuation score was -51.0%. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were 78.1, 73.9, 82.0, 79.1, and 77.4, in the percent change of ST-segment fluctuation score and 86.5, 84.8, 88.0, 86.7, and 86.3 in non-dipole phenomenon. The area under the curve of receiver-operating characteristics was 0.79 for the percent change of ST-segment fluctuation score and 0.86 for non-dipole phenomenon (p0.001). However, the incorporation of non-dipole phenomenon into a model with the percent change of ST-segment fluctuation score significantly improved C-statistics, indicating the enhancement of diagnostic performance in the detection of significant CAD (0.790 to 0.930; p0.001).Qualitative assessment of non-dipole phenomenon has a better diagnostic value than the quantitative parameter of percent change of ST-segment fluctuation score in the detection of significant CAD. Furthermore, this study found that the incorporation of non-dipole phenomenon into the percent change of ST-segment fluctuation score significantly improved the diagnostic performance of CAD detection.

Left Atrial Appendage Closure With the New Occlutech® DeviceAims Percutaneous left atrial appendage closure (LAAC) is a valuable treatment option for stroke prevention in patients with atrial fibrillation and a HAS-BLED-Score ≥3. Determinants of procedural safety events and neurological outcome of the patients with the Occlutech device (OD) are not established yet. Methods and Results Between 2012 and 2016, 30 patients underwent LAAC using the OD. This is a prospective study. Neurological examination and transesophageal echocardiography was performed directly before and after the procedure and after 1, 3, and 12 months. The OC was successfully implanted in 28 of the 30 enrolled patients (93%). Two patients presented a hemodynamic relevant pericardial effusion. A leak

Cardioembolic strokes are generally more lethal and disabling than other source of strokes. Data from PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) suggest that strokes after left atrial appendage occlusion (LAAO) with the Watchman device are less disabling than those in the warfarin group. No data assessing the severity of strokes after LAAO with the AMPLATZER Cardiac Plug (ACP) are available. The objective of the study was to evaluate the severity of cerebrovascular events after LAAO with the ACP in a population mostly characterized by an absolute or relative contraindication to oral anticoagulation. Data from the ACP multicenter registry were analyzed. Disabling strokes were defined as those with a modified Rankin score of 3 to 6 at 90 days after the event. A total of 1,047 subjects were included. The mean age and CHADS2 score were 75 ± 8 years and 2.8 ± 1.3, respectively. Procedural success was achieved in 97.3% and 4.9% of the patients presented procedural major adverse events. Clinical follow-up was complete in 98.2% of patients with a median of 13 months. There were 9 strokes (0.9%), 9 transient ischemic attacks (0.9%), and no intracranial hemorrhages (0%) at follow-up. After excluding 2 patients with pre-LAAO disability, functional assessment showed disabling events in 3 (19%) of the remaining 16 patients. The median time of presentation was 420 days (interquartile range 234 to 671) after LAAO, and 17 patients (94%) were on single-antiplatelet therapy when the event occurred. According to our results, cerebrovascular events after LAAO with the ACP system were infrequent and mostly nondisabling.

Background LAA occlusion has a similar stroke prevention efficacy compared to anticoagulation treatment for non-valvular atrial fibrillation. Objective The objective of this study was to assess the feasibility and safety of a modified Occlutech® left atrial appendage (LAA) closure device in a canine model. Methods The device was implanted in 10 dogs (33±1kg) using fluoroscopy and transesophageal echocardiography (TEE) guidance. The modified Occlutech® LAA occlusion device was compared with the current version, the Watchman device, and the Amplazter cardiac plug (ACP). LAA occlusion and anchoring to the LAA were evaluated. All dogs were assessed using angiography, TEE, and a gross anatomy examination. Results The 10 LAA occlusion devices were to be implanted into 10 dogs (5 modified Occlutech devices, 3 current version of Occlutech devices, 1 Watchman, and 1 ACP). LAA implantation was not performed in one dog due to transeptal puncture failure. The three current version of Occlutech devices were embolized immediately after implantation, so three modified devices of the same size were implanted securely without embolization. The mean implant size was 20.1±2.0mm. The devices chosen were a mean of 23.3±10.6% larger than the measured landing zone diameters. Post-implant angiography and TEE revealed well-positioned devices without pericardial effusion or impingement on surrounding structures. Conclusions The results of this acute animal study suggested that a modified Occlutech® LAA occlusion device was feasible and had greater anchoring performance in canines. Additional large clinical studies are needed to evaluate safety and efficacy.

Beim nichtvalvularem Vorhofflimmern sind >90 % der nachweisbaren kardialen Thromben im linken Vorhofohr („left atrial appendage“ [LAA]) lokalisiert. Insbesondere auf dieser Grundlage wurde in den letzten Jahren der katheterbasierte Verschluss des LAA als ein Verfahren zur Schlaganfallpravention bei Patienten mit nichtvalvularem Vorhofflimmern entwickelt. Eine erste randomisierte Studie zum katheterbasierten LAA-Verschluss hat vielversprechende Ergebnisse im Hinblick auf die Effektivitat und Sicherheit dieses Verfahrens im Vergleich zur oralen Antikoagulationstherapie mit Vitamin-K-Anatagonisten gezeigt. Dank der Weiterentwicklung der Implantationstechnik sowie der Devices hat die periprozedurale Sicherheit in den letzten Jahren in erfahrenen Zentren weiter zugenommen. In der klinischen Praxis wird der LAA-Verschluss aktuell insbesondere bei Patienten mit nichtvalvularem Vorhofflimmern und relevantem ischamischem Risiko (CHA2DS2-VASc-Score ≥2) sowie hohem Blutungsrisiko durchgefuhrt, d. h. bei Patienten, bei denen die Durchfuhrung einer dauerhaften Antikoagulationstherapie problematisch ist. Der Beitrag beschreibt die Entwicklung des Verfahrens, bisher vorliegende Erfahrungen aus randomisierten und Registerstudien, aktuelle Leitlinien und Expertenempfehlungen sowie den Einsatz in der klinischen Praxis.

Vorhofflimmern (VHF) ist die haufigste Herzrhythmusstorung und ist mit einem erhohten thrombembolischen Schlaganfallrisiko kardialen Ursprungs assoziiert. Der interventionelle Verschluss des linken Vorhofohrs (LAA) mittels LAA-Okkluder ist nicht nur sicher und mit hoher Erfolgsrate durchfuhrbar, sondern ist gleichzeitig eine gute Alternative zur oralen Antikoagulation (OAK), insbesondere fur Vorhofflimmer-Patienten, bei denen Kontraindikationen fur die OAK vorliegen, die ein hohes Risiko fur einen Schlaganfall und/oder Blutung haben sowie fur Patienten, die unter OAK einen Schlaganfall und/oder eine schwerwiegende Blutungskomplikation erleiden. Diese Ubersichtsarbeit schlussfolgert, dass der interventionelle LAA-Verschluss eine gute Alternative zur OAK ist, insbesondere beugt er bei Patienten einen Schlaganfall vor, die Probleme mit der OAK haben. In den nachsten Jahren werden eine Reihe von neuen LAA-Okkludern auf den Markt drangen. Die Frage, ob technische Unterschiede und Unterschiede im technischen Implantationsergebnis wie etwa Okkluder-Undichtigkeit klinische Ereignisse beeinflussen, wird man erst beantworten konnen, wenn mehr Langzeiterfahrung an groseren Patienten-Kollektiven vorliegt. Ebenso steht der direkte Vergleich zwischen LAA-Okkluder und den neuen OAK aus.

AIMS: This document aims to describe a standardised methodology for performing left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device, and to provide useful tips and tricks for operators with different levels of experience.METHODS AND RESULTS: Physicians who are experts in LAAO and had personal clinical experience with the AMPLATZER Amulet device were asked to contribute in the preparation of this consensus document. Twenty-seven physicians (20 interventional cardiologists and 7 electrophysiologists) from 14 different countries reviewed the manuscript. A step-by-step approach, simulating a real case, was followed. Starting with patient selection and planning, related cardiac imaging is discussed, followed by vascular access - transseptal puncture optimisation. Then, angiographic calibration/sizing and the required fluoroscopy views are explained and a device sizing strategy is proposed. Device preparation and de-airing is briefly described, followed by sheath exchange, device deployment steps, evaluation of device stability and decision for final release. The way to recapture and change a device is then shown, together with some additional tips on how to deal with challenging anatomies like "chicken wing" left atrial appendage. Finally, for operators who are switching from AMPLATZER Cardiac Plug to Amulet, the main differences between the two devices with respect to implantation technique are presented.CONCLUSIONS: In conclusion, this document reflects a consensus approach by expert implanters on the steps of LAAO technique and best practices for implantation of the AMPLATZER Amulet device, along with some practical tips to minimise the complication rate.

While fractional flow reserve (FFR) is a good diagnostic index to assess the myocardial ischemia, coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR) can be used to address microvascular status without any significant epicardial disease. The independent predictors for FFR and IMR are totally different and acts differently on the macro- and micro-vascular dysfunction. In high FFR patients, low CFR and high IMR which indicates the presence of overt microvascular disease demonstrated poor prognosis. Thus, comprehensive physiological assessments using FFR, CFR and IMR could improve the ability to discriminate patients at high risk of future events.

We here report the first European experience with the novel LAmbre left atrial appendage (LAA) occluder, a self-expanding device consisting of an umbrella and a cover connected by a central waist.A total of 60 patients (74.4 ± 8.3 years; 66.7% men; CHA2DS2-VASc: 4.0 ± 1.6, HAS-BLED score: 3.2 ± 1.3) with atrial fibrillation and contraindications to oral anticoagulation underwent left atrial appendage occlusion (LAAO) with the LAmbre device at two German centers between November 2013 and September 2015. Device success defined as correct placement of the device was achieved in all patients (100%). Resizing of the device was necessary in 3 (5%) patients. Device-related complications included 2 (3.3%) pericardial effusions on day 8 and 33 after the index procedure requiring pericardiocentesis. Transesophageal echocardiography at 6 months showed complete sealing of the LAA (residual jet flow of5 mm) in 51/54 (94.4%) patients. No device-related thrombus was documented. At 12 months transient ischemic attack was observed in 1 patient (1.6%) and minor bleeding in 3 patients (5%).Although minimizing procedure-related complications remains challenging, LAAO with the LAmbre showed high device success and good mid-term performance regarding prevention of stroke and bleeding.

Atrial fibrillation (AF) is common and is a prominent risk factor for ischemic stroke. Oral anticoagulant (OAC) therapy has been the main strategy for stroke prevention in AF patients; however, OAC therapy carries a bleeding risk and is not tolerated by all patients. Left atrial appendage (LAA) closure offers a non-pharmacological alternative for stroke prevention in patients with non-valvular AF. In this update, an overview of current and emerging LAA occluders is given - with special attention to the key design features of every single device and, if available, preclinical or clinical data.

Ischemic heart disease (IHD) remains a major public health burden worldwide. It is estimated that one third of adults in the United States has some form of IHD, including more than 17 million with coronary artery disease (CAD) and nearly 10 million with angina pectoris [1]. Nevertheless, the detection of myocardial ischemia in patients with presumed CAD remains a challenge in contemporary practice.

BACKGROUND The aim of this study was to evaluate clinical outcome after left atrial appendage (LAA) occlusion in real clinical practice and compare between Amplatzer cardiac plug (ACP) and Watchman. METHODS AND RESULTS From October 2010 to February 2015, 96 successful LAA occlusion procedures were performed using either ACP (n=50) or Watchman device (n=46) in non-valvular atrial fibrillation (AF) patients (59 male; age, 65.1±9.4 years; CHADS2, 2.5±1.2; CHA2DS2-VASC, 3.9±1.6; HAS-BLED, 2.7±1.3). The procedure success rate was 96.8%. There were serious complications in 4 patients (4.1%; 2 cardiac tamponade, 1 device embolization, and 1 major bleed). The anticoagulation cessation rate after 6 weeks was 92.7%. During mean 21.9-month follow-up, the incidence of death, stroke, systemic embolization and major bleeding was 5.2%, 4.2%, 0% and 1.0%, respectively. On transesophageal echocardiography of 93 patients within 6 months after the procedure, 24 residual leaks were observed (25.8%; 2 mild, 18 moderate, and 4 major). Clinical outcome was similar for the 2 devices, but peridevice leakage was more frequent with the Watchman than the ACP. CONCLUSIONS LAA occlusion was feasible in non-valvular AF patients with high risk of stroke and hemorrhage. The ACP and Watchman devices were similar in terms of procedural and clinical outcomes. (Circ J 2016; 80: 1123-1130).

Aims Interventional left atrial appendage closure (LAAC) is an emerging alternative to oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) in concomitance with a contraindication for standard OAC. This sub-analysis of the LAARGE registry aimed to investigate differences between different LAA morphologies in a real-world setting. Methods and results This prospective, multicentre, observational registry included 562 patients from 37 centres with ineligibility for long-term OAC between April 2014 and January 2016. Baseline characteristics, indications, procedural data and complications were registered according to each LAA morphology (i.e., chicken wing, cauliflower, windsock, cactus and atypical morphologies). Implantation success was high across the four typical anatomies (≥97.5%, p=n.s.); only atypical anatomies exhibited a lower success rate (94%). The cactus-shaped LAA was linked to a trend indicating a shorter fluoroscopy time, while the atypical LAA was linked to a significantly prolonged fluoroscopy time (p=0.089 and p=0.025 versus the overall mean, respectively). Periprocedural and intra-hospital complications were generally rare, with no differences among the different morphologies (p=n.s.). Conclusions Procedural success as well as the complication rates of LAAC were not different among the four typical LAA morphologies. A lower implantation success rate was only obvious in patients with atypical LAA morphologies.

Background Left atrial appendage closure (LAAC) for stroke prevention is an increasingly performed intervention. Aims This prospective study aims to evaluate the incidence of long-term magnetic resonance imaging (MRI)-detected brain lesions as well as potential changes of neurocognitive function after percutaneous LAAC. Methods Brain MRI at 3 T was performed within 24 hr before and after LAAC. A follow-up MRI was carried out after three months. Neuro-cognitive examination using the National Institutes of Health Stroke Scale (NIHSS) score and the Montreal Cognitive Assessment (MoCA) Test was performed. Results Successful device implantation was achieved in all 25 patients (age 74.6 ± 10.2 years, male = 17) using the Amulet (n = 20), Occlutech (n = 3), or a Lambre (n = 2) device. In 12/25 (48%) patients, acute brain lesions (ABL) were detected after LAAC. A three-month follow-up MRI was performed in seven patients, and no new ABLs were seen. In 5/7 (71%) patients, there were no residual changes from the ABLs detectable. However, the FLAIR sequence was still positive in two patients. After LAAC, there were no significant differences in the MoCA-test (mean 24.3 ± 4.5 vs. 23.5 ± 4.5; P = 0.1) and the NIHSS-score (mean 0.9 ± 1.6 vs. 1.2 ± 1.8; P = 0.1). This was the same at the three-month follow-up (MoCA-test 23.5 ± 4.5 vs. 23.8 ± 2.7; P = 0.3; NIHSS-score 1.2 ± 1.8 vs. 1.0 ± 0.8; P = 0.4). Conclusion While new MRI-detected brain lesions are commonly observed after percutaneous LAAC, ABLs were no longer detectable in 71% of the patients at the three-month follow-up. There were no significant changes in neurocognitive function after LAAC and at the three-month follow-up.

Background Percutaneous catheter-based left atrial appendage closure (LAAC) is a procedure being increasingly performed in patients with atrial fibrillation and high bleeding risk. Objective The purpose of this study was to evaluate the incidence of magnetic resonance imaging (MRI)-detected acute brain lesions (ABLs) as well as potential changes in neurocognitive function after percutaneous LAAC in patients with atrial fibrillation. Methods Brain MRI at 3 T was performed within 24 hours before and after LAAC along with neurologic (National Institutes of Health Stroke Scale [NIHSS] score) and cognitive (Montreal Cognitive Assessment [MoCA] test) assessment. Acquired MRI sequences included high-resolution diffusion-weighted imaging as well as fluid-attenuated inversion recovery. Results Successful device implantation was achieved in all 23 patients (age 74.1 ± 10.5 years; 16 male) using the Amulet (n = 18), Occlutech (n = 3), or LAmbre (n = 2) device. Thirty-seven ABLs were detected by MRI in 12 of 23 patients (52%) after LAAC. The number of periprocedural LAA angiographies was significantly higher in patients with ABL than in those without ABL (1.67 ± 0.65 vs 1.18 ± 0.41; P = .048) and was associated with a higher number of ABL (ρ = 0.615; P = .033). Compared to pre-LAAC assessment, post-LAAC MoCA and NIHSS scores revealed similar results. After LAAC, MoCA test (mean 24.1 ± 4.6 vs 23.2 ± 4.6; P = .09) and NIHSS score (mean 1.0 ± 1.7 vs 1.2 ± 1.8; P = .1) were similar between patients with and those without ABL, respectively. Conclusion MRI-detected ABLs are commonly observed after percutaneous LAAC. The number of LAA angiographies is significantly associated with the number of ABLs; however, the clinical implications of ABL have yet to be determined.

Vorhofflimmern (VHF) ist die haufigste Herzrhythmusstorung und ist assoziiert mit einem erhohten thrombembolischen Schlaganfallrisiko kardialen Ursprungs. Der interventionelle Verschluss des linken Vorhofohrs (LAA) mittels LAA-Okkluder ist nicht nur sicher und mit hoher Erfolgsrate durchfuhrbar, sondern ist gleichzeitig eine gute Alternative zur oralen Antikoagulation (OAK), insbesondere fur Vorhofflimmer-Patienten, bei denen Kontraindikationen fur die OAK vorliegen, die ein hohes Risiko fur einen Schlaganfall und/oder eine Blutung haben sowie fur Patienten, die unter OAK einen Schlaganfall und/oder eine schwerwiegende Blutungskomplikation erleiden. Zwei LAA-Okkluder-Systeme, WATCHMAN und ACP, haben sich in der Patientenversorgung bewahrt. Daten aus der kontrollierten, randomisierten Studie PROTECT-AF liegen fur das WATCHMAN-System vor, die belegen, dass WATCHMAN der oralen Antikoagulation mit Warfarin klinisch uberlegen ist (Gesamtmortalitat -34 %). Die prospektive, nicht-radomisierte ACP European Post-Market Registry Studie fand eine Reduktion des Schlaganfall-Risikos um 67 % im Vergleich zu einer Kohorte, die mit Plattchenhemmern behandelt wurde. Diese Ubersichtsarbeit schlussfolgert, dass der interventionelle LAA-Verschluss eine gute Alternative zur OAK ist, insbesondere beugt er bei Patienten einen Schlaganfall vor, die Probleme mit der OAK haben. In den nachsten Jahren werden eine Reihe von neuen LAA-Okkludern auf den Markt drangen. Die Frage, ob technische Unterschiede und Unterschiede im technischen Implantationsergebnis wie etwa Okkluder-Undichtigkeit klinische Ereignisse beeinflussen, wird man erst beantworten konnen, wenn mehr Langzeiterfahrung an groseren Patienten-Kollektiven vorliegt. Ebenso steht der direkte Vergleich zwischen LAA-Okkluder und den neuen OAK aus.

Left atrial appendage occlusion (LAAO) is predominantly performed under general anesthesia, guided by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE). The LAmbre (Lifetech Science, Shenzhen, China) is a novel LAAO device that allows: 1) a less selective transseptal

Objectives: The study evaluated the feasibility and safety of a novel left atrial appendage (LAA) occluder (LAmbre (TM), Lifetech Scientific Corp., China) in canines., Objectives: The study evaluated the feasibility and safety of a novel left atrial appendage (LAA) occluder (LAmbre™, Lifetech Scienti fic Corp., China) in canines. Background: Transcatheter LAA occlusion is comparable towarfarin in preventing atrial fibrillation-related strokes. Methods: Twenty-two healthy dogs (28 ± 3 kg) received LAmbre implants. The device is delivered by an 8 –10 French sheath and has full recapture and repositioning capabilities. All dogs received 1-week antibiotics and 4-week aspirin (80 mg daily) after implants and they were sacri ficed in groups at Days 1–3 (n = 5), 1- (n = 7), 3- (n = 4) and 6-months (n = 6) for pathological examinations. Transthoracic echocardiography (TTE) was performed immediately after implant, at Day 3 and before sacri fice. Results: The LAmbre was successfully implanted, retrieved, repositioned and re-implanted in all dogs. The mean implant size was 24 ± 3 mm and the device chosen was 36 ± 7% larger than the measured landing zone diameter. Improper device selection (only 21% oversizing) resulted in dislodgement and death of 1 dog on Day 3. Post-implant angiography and TTE showed well-positioned device without pericardial effusion or impingement on surrounding structures. Late complications included device-related thrombus at 1 month (n = 1) and clinically insigni ficant pericardial effusion at Day 3 (n = 1). Complete healing on the atrial facing surface with optimal LAA obliteration was con firmed by gross andmicroscopic examinations in dogs that have been followed up ≥3 months (n=10). No infarctwas detected inmajor organs. Conclusions: Our preliminary data suggested the LAmbre™ device is feasible with high success rate in canines. Further studies are needed to evaluate its safety and ef ficacy.

Despite the availability of several advanced non-invasive diagnostic tests such as echocardiography and magnetic resonance imaging, electrocardiography (ECG) remains as the most widely used diagnostic technique in clinical cardiology. ECG detects electrical potentials that are generated by cardiac electrical activity. In addition to electrical potentials, the same electrical activity of the heart also induces magnetic fields. These extremely weak cardiac magnetic signals are detected by a non-invasive, contactless technique called magnetocardiography (MCG), which has been evaluated in a number of clinical studies for its usefulness in diagnosing heart diseases. We reviewed the basic principles, history and clinical data on the diagnostic role of MCG in coronary artery disease and cardiac arrhythmias.

History of major gastrointestinal (GI) bleeding may represent a frequent clinical indication for left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). This study aims to investigate the procedural safety and long-term outcome of patients with previous major GI bleeding (MGIB) who underwent LAAO. Data from the Amplatzer Cardiac Plug multicenter registry on 1,047 patients were analyzed. Patients with previous MGIB as indication for LAAO were compared with patients without previous MGIB. A total of 151 patients (14.4%) with previous MGIB were identified. Periprocedural major bleeding events were more frequent in patients with previous MGIB (4.0% vs 0.8%, p = 0.001). With an average follow-up of 1.3 years, the observed annual rate of stroke/transient ischemic attack and major bleeding for patients with previous MGIB were 2.1% (61.4% relative reduction according to the Congestive Heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65-74, and Sex (female) [CHA2DS2-VASc] score) and 4.6% (20.1% relative reduction according to the expected rate based on the Hypertension, Abnormal renal/liver function (1 point each), Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs/alcohol concomitantly (1 point each) [HAS-BLED] score), respectively. In conclusion, in patients with non-valvular atrial fibrillation and previous MGIB, LAAO was associated with a low annual rate of stroke/transient ischemic attack. Periprocedural major bleeding events were more frequent in this specific population although the annual major bleeding rate showed a 20.1% relative risk reduction according to the HAS-BLED score.

AIMS: The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study.METHODS AND RESULTS: This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5% male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8% of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4% had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0% of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2% of patients. Patients were discharged on a single antiplatelet agent (23.0%), dual antiplatelets (54.3%) or an oral anticoagulant (18.9%). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (CONCLUSIONS: This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.

The AMPLATZER™ Cardiac Plug device is designed for percutaneous occlusion of the left atrial appendage (LAA) for stroke prophylaxis in patients with atrial fibrillation (AF) who are contraindicated or intolerant to oral anticoagulation. While updated guidelines start to refer to this therapy (Camm A, Eur Heart J, doi:10.1093/eurheartj/ehs253, 2012) and operators gain experience with this relatively new technique, continuing efforts are focused on maximizing the safety of the implantation procedure. This paper is aimed at explaining and illustrating the distinct steps and specific considerations related to the implantation of the AMPLATZER™ Cardiac Plug.

Background: The Amplatzer Amulet (St. Jude Medical, Minneapolis, MN, USA) is a second gen­eration Amplatzer device for left atrial appendage (LAA) occlusion (LAAO) for stroke prophylaxis in patients with atrial fibrillation. This research sought to assess the clinical performance of the Amplatzer Amulet device and in follow up for 12 months. Methods: In this single-center registry patients with atrial fibrillation and contraindication to oral anticoagulation underwent LAAO with the Amplatzer Amulet device. Follow-up was performed before discharge, by transesophageal echocardiography (TEE) after 6 weeks and telephone interview after 3, 6 and 12 months. Results: Between October 2014 and August 2015 50 patients (76.1 ± 8.3 years; 30 male) were en­rolled. Procedural success was achieved in 49 (98%) patients. Major periprocedural adverse events were observed in 4 (8%) of patients: 1 device embolization, 2 pericardial effusions requiring pericardiocente­sis and 1 prolonged hospital stay due to retropharyngeal hematoma from the TEE probe. Follow-up TEE was available in 38 of 50 patients showing complete LAA sealing in all. 2 device-related thrombi were also documented. At 12-month follow-up 7 patients had died unrelated to the device. Ischemic stroke occurred in 3 patients. According to neurological examination two were classified as microangiopathic and not cardio-embolic. The other one could not be classified. Bleeding complications (5 minor, 3 major) were documented in 8 patients. Conclusions: Although minimizing procedure-related complications remains challenging, LAAO with the Amplatzer Amulet device showed high procedural success and excellent LAA sealing. (Cardiol J 2017; 24, 2: 131–138)

BACKGROUND: In patients with non-valvular atrial fibrillation (NVAF), intracranial bleeding (ICB) constitutes a very challenging situation in which the rate of both ischemic and hemorrhagic events is increased. In these patients, left atrial appendage occlusion (LAAO) might represent a very valid alternative.OBJECTIVES: To investigate the procedural safety and long-term outcome of patients undergoing LAAO therapy due to previous ICB.METHODS: Data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients were analyzed. Patients with previous ICB as indication for LAAO were compared to patients with other indications.RESULTS: A total of 198 patients (18.9%) with previous ICB were identified. The CHA2DS2-VASc score was similar (4.5±1.5 vs. 4.4±1.6, p=0.687) and the HAS-BLED score was higher in patients with previous ICB compared to those without (3.5±1.1 vs. 3.1±1.2, pCONCLUSIONS: In patients with NVAF and previous ICB, LAAO seemed to be a safe procedure and was associated with a significant reduction in stroke/TIA and a remarkably low frequency of major bleeding during follow-up.

Percutaneous left atrial appendage closure (LAAC) is a valuable treatment option for stroke prevention in patients with atrial fibrillation and a HAS-BLED-Score ≥3. Determinants of procedural safety events and neurological outcome of the patients with the Occlutech device (OD) are not established yet.Between 2012 and 2016, 30 patients underwent LAAC using the OD. This is a prospective study. Neurological examination and transesophageal echocardiography was performed directly before and after the procedure and after 1, 3, and 12 months. The OC was successfully implanted in 28 of the 30 enrolled patients (93%). Two patients presented a hemodynamic relevant pericardial effusion. A leak3 mm could be documented direct after implantation in 4 patients. After 3 months, there were only 2/4 patients with persistent LAA leakage with a maximum leakage of3 mm. The correct position of the device was confirmed in 27/28 patients during 3-month follow-up. In 2 patients, there was a thrombus at the OC. In 12 patients, a transoesophageal echocardiography was performed after 12 months. All patients (12/12) showed a correct placement of the device. None of the patients developed a clinically apparent stroke or died during follow-up.In this uncontrolled, nonrandomized study, acute and 3-month follow-up success of LAAC using OD was high. No patient showed significant neurological deficits.

The case of a 78-year-old female patient who suffered atrial fibrillation and persistent thrombus in the left atrial appendage despite sufficient anticoagulation is reported. The case is chosen to demonstrate the complexity inherent in prophylaxis as well as risk evaluation of thromboembolism on the basis of clinical and echocardiographic criteria. We also discuss transesophageal echocardiography as the standard diagnostic procedure for detection of intracardiac thrombi prior to cardioversion as well as cardiac computer tomography as an alternative.

Stroke is the third leading cause of mortality and is one of the leading cause of disability in the world today. Although underused, anticoagulation with warfarin is still the treatment of choice for prevention of stroke in patients with AF, though hemorrhage is clearly increased in the anticoagulated patient. The substantial difficulties associated with warfarin use give reasons for the continuing challenge of decision making about antithrombotic therapy. They have led to a search for alternative approaches of stroke prophylaxis resulting in a strategy of mechanically sealing the left atrial appendage (LAA) and excluding it from the systemic circulation. A couple of years ago a percutaneous transcatheter transseptal approach to LAA occlusion has become feasible. Since then, valuable technical knowledge and a proof of concept emerged from clinical trials using three different systems. However, also the intervention bears a risk. Thus, identifying those patients who gain the most from either therapy is crucial which, in the first line, means to calculate the risk of stroke or bleeding. Unfortunately, patients with some defined comorbidities are at risk of both, cerebral embolism or hemorrhage. Whether this target group may benefit from LAA occlusion is a matter of this discussion.

Cardiac emboli in patients with atrial fibrillation are one of the major causes of ischemic stroke. Because the vast majority of these cardiac emboli descend from the left atrial appendage (LAA), the therapeutic strategy of percutaneous transcatheter occlusion of the LAA by means of a mechanical implant was a logical consequence. Three different devices have been developed and used in humans: PLAATO, WATCHMAN, and ACP. The PLAATO implant, a “soccer ball” shaped self-expanding nitinol cage has demonstrated stroke prevention capability in small, uncontrolled studies. The WATCHMAN implant, a “half rugby ball” shaped self-expanding nitinol cage, has demonstrated non inferiority compared to warfarin treatment in the randomized, controlled PROTECT AF trial. The ACP implant is also a self-expanding nitinol cage. However, its design is of fundamental difference compared to the other two implants. ACP consists of two parts connected by a short waist, which are an “ice-hockey puck” shaped body for the implant fixation in the appendage wall, and a flexible disc for sealing the appendage ostium. Due to the very flexible connecting waist between the two parts, ACP implant adapts itself to the LAA, which appears in significant individual structural variabilities. The currently unpublished initial experience with ACP in Europe is encouraging. Transcatheter occlusion of the LAA offers an appealing way to reduce the incidence of cardioembolic stroke in patients with atrial fibrillation. However, the concerns about procedural safety and the need for long-term follow up should be addressed before this potentially important technology is deployed widely. The transcatheter occlusion of left atrial appendage, therefore, has the potential to become, but is not yet a real alternative to anticoagulation.

Atrial fibrillation is the most common cardiac arrhythmias, and a major cause of morbidity and mortality due to cardioembolic stroke. The left atrial appendage is the major site of thrombus formation in non-valvular atrial fibrillation. Loss of atrial systole in atrial fibrillation and increased relative risk of associated stroke point strongly toward a role for stasis of blood in left atrial thrombosis, although thrombus formation is multifactorial, and much more than blood flow irregularities are implicated. Oral anticoagulation with vitamin-K-antagonists is currently the most effective prophylaxis for stroke in atrial fibrillation. Unfortunately, this treatment is often contraindicated, particularly in the elderly, in whom risk of stroke is high. Moreover, given the risk of major bleeding, there is reason to be skeptical of the net benefit when warfarin is used in those patients. This work reviews the pathophysiology of cardioembolic stroke and critically spotlights the current status of preventive anticoagulation therapy. Various techniques to exclude the left atrial appendage from circulation were discussed as a considerable alternative for stroke prophylaxis.

Objective: Magnetocardiography (MCG) as a noninvasive, noncontact and risk-free diagnostic method predicts ischemic coronary artery disease (CAD) in patients with acute chest pain at admission with high accuracy. However, it remains unclear whether MCG findings can add prognostic information. Method: A cohort of 402 consecutive patients presenting at the intensive care unit (ICU) with acute chest pain without ST segment elevation (NSTEMI) were included in a prospective registry. In order to prove the prognostic value of MCG a head-to-head comparison of the admission MCG, ECG, TnI, and ECHO tests was made. Results: In 43 patients (10.7%) the MCG could not be analyzed due to insufficient signal-to-noise ratio. Complete follow-up over a period of up to 3 years was obtained in 355 out of the 359 patients (98.9%). Age at admission was 67.2 ± 10.3 years, 59.7% males. In the group of patients with an abnormal MCG at admission, 43 out of 249 patients (17.3%) died in the follow-up period, while in the group of patients with a normal MCG at admission only 4 out of 106 patients died (3.77%). The relative risk was 4.58 (95% confidence intervals: 1.68–12.42). A multivariate regression analysis revealed the highest mortality risk for patients with diabetes mellitus and an abnormal MCG at admission (RR = 18.0; 95% CI: 2.49–133.3). Conclusion: Resting MCG at hospital admission predicts 3-year mortality in patients presenting with acute chest pain without ST segment elevation in the ECG. MCG seems to be valuable in identifying chest pain patients at highest risk.

Various radiographic contrast media (RCM) significantly influence the morphology of erythrocytes, especially the formation of echinocytes [Scand. J. Clin. Lab. Invest. 35 (1975), 1-43; Microvasc. Res. 60 (2000), 193-200; Herz 23 (2003), 35-41]. Microscopic studies, however, have shown that these changes of erythrocyte morphology are possibly reversible [Acta Radiol. 37 (1996), 214-217]. The aim of this study was to proof if the RCM-induced echinocyte formation can be reversed by a resuspension in autologous plasma. In this study four RCMs were tested (Iodixanol, Iohexol, Iomeprol and Iopromide). These RCM induced echinocyte formation (after suspension of erythrocytes in plasma/RCM mixtures for 10 min at 37 degrees C), which was reversible after resuspension in autologous RCM-free plasma (resuspension time 5 min at 37 degrees C). Especially for Iomeprol and Iopromide - the RCMs which induced the strongest echinocyte formation - an echinocyte reduction from 94.2% to 44.5% and for Iopromide from 80.6% to 50.4% occurred. The echinocyte formation was influenced by the type of RCM as well as by the RCM concentration. The same was true for the reversibility of echinocyte formation due to resuspension in autologous plasma (type of RCM: p