[Extracorporeal Life Support in Critical Care Medicine]. / Extrakorporaler Life Support in der Intensivmedizin.

Veno-arterial extracorporeal life support (ECLS) may be indicated in patients with refractory heart failure. The list of conditions in which ECLS is successfully used is growing and includes cardiogenic shock following myocardial infarction, refractory cardiac arrest, septic shock with low cardiac output and severe intoxication. Femoral ECLS is the most common and often preferred ECLS-configuration in the emergency setting. Although femoral access is usually quick and easy to establish, it is also associated with specific adverse haemodynamic effects due to the direction of blood flow and access-site complications are inherent. Femoral ECLS provides adequate oxygen delivery and compensates for impaired cardiac output. However, retrograde blood flow into the aorta increases left ventricular afterload and may worsen left ventricular stroke work. Therefore, femoral ECLS is not equivalent to left ventricular unloading. Daily haemodynamic assessments are crucial and should include echocardiography and laboratory tests determining tissue oxygenation. Common complications include the harlequin-phenomenon, lower limb ischaemia or cerebral events and cannula site or intracranial bleeding. Despite a high incidence of complications and high mortality, ECLS is associated with survival benefits and better neurological outcomes in selected patient groups.

Outcome of a polymer-free drug-coated coronary stent in bifurcation lesions-Pilot registry with serial OCT imaging.

BACKGROUND: Polymer-free and carrier-free drug-coated stents (DCS) represent a novel therapeutic option for the treatment of coronary artery disease. The objective of this pilot registry is to evaluate the safety and efficacy of DCS implantation in bifurcation lesions. METHODS: Overall, 23 consecutive patients with 24 lesions received a Biolimus A9-coated DCS for coronary bifurcation lesions. Patients were examined with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 3-6 months of follow-up. RESULTS: A total of 23 patients with 24 bifurcation lesions were included in this study. Nine (33.3%) lesions of eight patients revealed angiographical target lesion failure due to in-stent restenosis (ISR). In total, 19 patients with 20 bifurcation lesions were suitable for OCT analysis. A total of 2936 struts were analyzed and 14 struts (0.47%) were classified as malapposed. The mean luminal area (mm2) was not different in lesions with ISR vs. lesions with no ISR (5.07 ± 2.0 vs. 5.73 ± 1.34, p = 0.39) at follow-up. Lesions with ISR showed higher mean neointimal burden (27.11 ± 10.59 vs. 13.93 ± 9.16%, respectively; p = 0.009). All of the patients who presented with significant ISR required percutaneous re-intervention. CONCLUSIONS: We observed a high rate of DCS ISR in bifurcation lesions, possibly related to increased inflammation and neoatherosclerosis. The small size of the study warrants careful interpretation of our results. Larger trials are necessary to expand knowledge of these findings.

[ECMO support during the first two waves of the corona pandemic-a survey of high case volume centers in Germany]. / ECMO-Unterstützung während der ersten 2 Wellen der Coronapandemie ­ eine Umfrage an Zentren mit hohen Fallzahlen in Deutschland.

BACKGROUND: At the onset of the coronavirus pandemic, concerns were raised about sufficiency of available intensive care resources. In many places, routine interventions were postponed and criteria for the allocation of scarce resources were formulated. In Germany, some hospitals were at times seriously burdened during the course of the pandemic. Intensive care units in particular experienced a shortage of resources, which may have led to a restriction of services and a stricter indication setting for resource-intensive measures such as extracorporeal membrane oxygenation (ECMO). The aim of this work is to provide an overview of how these pressures were managed at large ECMO centers in Germany. METHODS: One representative of each major ECMO referral center in Germany was invited to participate in an online survey in spring 2021. RESULTS: Of 34 invitations that were sent out, the survey was answered by 23 participants. In all centers, routine procedures were postponed during the pandemic. Half of the centers increased the number of beds on which ECMO procedures could be offered. Nevertheless, in one-third of the centers, the start of at least one ECMO support was delayed because of a feared resource shortage. In 17% of centers, at least one patient was denied ECMO that he or she would have most likely received under prepandemic conditions. CONCLUSION: The results of this online survey indicate that the experienced pressures and resource constraints led some centers to be cautious about ECMO indications.

Efficacy and safety of ECG-synchronized pulsatile extracorporeal membrane oxygenation in the clinical setting: The SynCor Trial.

INTRODUCTION: Mechanical circulatory support (MCS) devices are increasingly used as a treatment option in resuscitation or in patients with cardiogenic shock (CS). Prophylactic implantation in high-risk percutaneous coronary interventions (HRPCI) is another upcoming indication. The i-cor ECG-synchronized cardiac assist device combines the hemodynamic support of a veno-arterial extracorporeal membrane oxygenation (VA-ECMO) with the ability to generate a pulsatile flow and thus decreasing adverse effects of VA-ECMO on myocardial function. Aim of this study was to obtain data concerning feasibility, safety and outcomes in both indications. METHODS: A total of 47 patients (34 HRPCI, 13 CS) were included in nine German centers and participated in this study. Demographic and clinical parameters, procedural as well as follow-up data were prospectively recorded and analyzed. RESULTS: Device implantation and initiation of ECG-synchronized cardiac assist was technical successful in all cases and no failures of the consoles or disposable parts were observed. Furthermore, intended percutaneous coronary interventions and successful weaning from cardiac assist was achieved in 97.1% of HRPCI patients. We observed a 30d-survival of 94.1% in the HRPCI group and 69.2% in the CS group. Main complications in both groups were bleeding events (14.7% HRPCI, 23.1% CS) and critical limb ischemia (2.9% HRPCI, 38.5% CS). CONCLUSION: The i-cor ECG-synchronized cardiac assist device appears safe and feasible showing clinical outcomes comparable to existing data in the setting of high-risk percutaneous coronary interventions and acute cardiogenic shock. Further prospective trials are warranted to identify optimal patient and interventional characteristics that will benefit most of this novel kind of mechanical circulatory support.

Outcome Prediction in Patients with Severe COVID-19 Requiring Extracorporeal Membrane Oxygenation-A Retrospective International Multicenter Study.

The role of veno-venous extracorporeal membrane oxygenation therapy (V-V ECMO) in severe COVID-19 acute respiratory distress syndrome (ARDS) is still under debate and conclusive data from large cohorts are scarce. Furthermore, criteria for the selection of patients that benefit most from this highly invasive and resource-demanding therapy are yet to be defined. In this study, we assess survival in an international multicenter cohort of COVID-19 patients treated with V-V ECMO and evaluate the performance of several clinical scores to predict 30-day survival. METHODS: This is an investigator-initiated retrospective non-interventional international multicenter registry study (NCT04405973, first registered 28 May 2020). In 127 patients treated with V-V ECMO at 15 centers in Germany, Switzerland, Italy, Belgium, and the United States, we calculated the Sequential Organ Failure Assessment (SOFA) Score, Simplified Acute Physiology Score II (SAPS II), Acute Physiology And Chronic Health Evaluation II (APACHE II) Score, Respiratory Extracorporeal Membrane Oxygenation Survival Prediction (RESP) Score, Predicting Death for Severe ARDS on V­V ECMO (PRESERVE) Score, and 30-day survival. RESULTS: In our study cohort which enrolled 127 patients, overall 30-day survival was 54%. Median SOFA, SAPS II, APACHE II, RESP, and PRESERVE were 9, 36, 17, 1, and 4, respectively. The prognostic accuracy for all these scores (area under the receiver operating characteristic-AUROC) ranged between 0.548 and 0.605. CONCLUSIONS: The use of scores for the prediction of mortality cannot be recommended for treatment decisions in severe COVID-19 ARDS undergoing V-V ECMO; nevertheless, scoring results below or above a specific cut-off value may be considered as an additional tool in the evaluation of prognosis. Survival rates in this cohort of COVID-19 patients treated with V­V ECMO were slightly lower than those reported in non-COVID-19 ARDS patients treated with V-V ECMO.

Targeted temperature management in patients undergoing extracorporeal life support after out-of-hospital cardiac arrest: an EURO-ELSO 2018 annual conference survey.

Targeted temperature management and extracorporeal life support, particularly extracorporeal membrane oxygenation in patients undergoing cardiopulmonary resuscitation, represent outcome-enhancing strategies for patients following in- and out-of-hospital cardiac arrest. Although targeted temperature management with hypothermia between 32°C and 34°C and extracorporeal cardiopulmonary resuscitation bear separate potentials to improve outcome after out-of-hospital cardiac arrest, each is associated with bleeding risk and risk of infection. Whether the combination imposes excessive risk on patients is, however, unknown.

Neuron-specific-enolase as a predictor of the neurologic outcome after cardiopulmonary resuscitation in patients on ECMO.

BACKGROUND: Neuron-specific-enolase (NSE) is frequently used to predict the neurologic outcome in persistently unconscious patients after cardiopulmonary resuscitation (CPR). However, its predictive value is unclear in the setting of veno-arterial extracorporeal membrane oxygenation therapy (ECMO). Aim of this project is to evaluate the predictive value of NSE in ECMO patients. METHODS: NSE was measured after 24, 48, and 72 h in post-CPR ECMO patients. Neurologic status was evaluated using the best Cerebral Performance Categories Score (CPC) during the hospital stay. Patients who deceased within the first 24 h and patients who were awake during the first 24 h were excluded. ROC curves were calculated to assess the discriminative ability of single NSE measurements. Trajectories of serial NSE values were investigated using latent class mixed models. RESULTS: The derivation cohort consisted of 65 patients, 30-day all-cause mortality was 47.7% and a poor neurological outcome with a CPC score of 4-5 was seen 30.7%. NSE measurement after 48 h showed the best discrimination for poor neurological outcome (AUC of 0.87 in the ROC curve; cut-off value of 70 µg/L). Specificity was highest if using serial NSE measurements at all three time points. These results could be validated in an external cohort of 64 patients. CONCLUSION: In post-CPR patients on ECMO, NSE can be used to assess the neurologic outcome. Importantly, specificity was highest if using serial NSE measurements. Further research using prospective datasets is needed to verify these findings.

Optical coherence tomography-guided versus angiography-guided implantation of everolimus-eluting bioresorbable vascular scaffolds: Comparison of coverage, apposition and clinical outcome. The ALSTER-OCT ABSORB registry.

BACKGROUND: Suboptimal implantation of everolimus-eluting bioresorbable vascular scaffolds (EE-BVS) leading to strut malapposition and lack of neointima coverage has been hypothesized to be linked to late BVS-thrombosis. Optical coherence tomography (OCT) allows assessing subtle differences in BVS-healing. We aimed to link 6-months OCT-data on EE-BVS coverage and malapposition to implantation technique and clinical outcome. METHODS: Twenty-nine consecutive EE-BVS-patients were included. EE-BVS-implantation was guided by angiography in the first 17 patients (group 1). Vessel sizing prior to implantation and implantation result was assessed by OCT in the 12 following patients (group 2). EE-BVS-implantation was performed in both groups with adequate lesion preparation, sizing and systematic high-pressure post-dilatation. All patients received 6-months invasive control including OCT-analysis and clinical follow-up for 2 years. RESULTS: The rate of uncovered struts was group 1: 10.8 ± 10.0%; group 2: 10.6 ± 8.2%, p = 0.934. Target lesion failure due to BVS-thrombosis occurred in 2/17 patients at 9 and 18 months (11.8%, group 1), and no patients in group 2 (p = 0.218). CONCLUSIONS: Optical coherence tomography analysis at 6-months following EE-BVS-implantation finds almost 90% of struts to be covered. No difference between OCT vs. angiography-guided EE-BVS-implantation was observed. OCT at 6-months was not able to predict late BVS-thrombosis of EE-BVS.

Safety and feasibility of interventional left atrial appendage closure without contrast agent.

Aims: Interventional left atrial appendage closure (LAAC) is routinely performed under both echocardiographic and angiographic guiding. However, adverse outcomes, e.g., kidney injury and cerebral embolism, might be associated with injections of contrast agent into the LAA. Therefore, this prospective registry investigated the safety and feasibility of LAAC without the support of angiographic images as the default approach. Methods and results: This single-centre registry included a total of 46 non-selected, consecutive patients. In the first 25 patients (54%), LAAC with the Amulet device was performed routinely with LAA angiography prior to implantation and after release of the device. The following 21 patients (46%) were treated without the use of contrast agent. The combination of successful implantation and lack of procedural complications was regarded as the primary endpoint. Procedure time, number of recapture manoeuvres, change of device size, compression, leakage, dose area product and late thrombosis on the device were investigated as secondary endpoints. Besides the longer fluoroscopy time and duration of the procedure in the group using angiography, no significant differences could be found. Major complications occurred equally often in both cohorts. Conclusions: Interventional LAAC with the Amulet device can be performed safely without the use of contrast agent. This approach might help to enhance the use of LAAC in patients at high risk of contrast-induced nephropathy and procedural stroke.

Improved Algorithm for Ostium Size Assessment in Watchman Left Atrial Appendage Occlusion Using Three-Dimensional Echocardiography.

AIMS: Correct sizing of the ostium is a crucial step in left atrial appendage (LAA) occlusion procedures. However, unfavorable anatomy of the ostium often complicates the assessment of the true ostium diameter. We hypothesized that area-derived diameter (ADD) and perimeter-derived diameter (PDD) from three-dimensional transesophageal echocardiogram (3D-TEE) can facilitate this step of the procedure as compared with two-dimensional (2D) measurements. METHODS AND RESULTS: For 55 patients within the ALSTER-LAA registry, retrospective analysis of PDD and ADD was correlated with 2D measurements used during the procedure to ascertain correct size of the Watchman device (Boston Scientific). The observed data were put into relation to the calculated area of the device with 10%-30% compression and the clinical outcome after 30 days. 3D area and perimeter measurements of the LAA ostium matched the calculated range of the different device sizes. Recapture during implantation, gaps <5 mm, and device size changes were more often observed when ADDs would also have suggested the use of a larger device. CONCLUSION: 3D ADDs and PDDs are feasible to use in device size decisions. Employing these measurements may allow operators to further reduce intraprocedural recapture maneuvers, peridevice leakage, and device size changes.

Rationale of cerebral protection devices in left atrial appendage occlusion.

AIMS: Aims of this case-series were to assess the feasibility of cerebral protection devices in interventional left atrial appendage occlusion (iLAAO) procedures and to yield insight into the pathomorphological correlate of early, procedural cerebral embolization during iLAAO. METHODS AND RESULTS: Five consecutive patients underwent iLLO flanked by the Sentinel CPS® (Claret Medical, Inc., Santa Rosa, CA) cerebral protection system. Placement and recapture of the Sentinel® device as well as the iLAAO were successful and safe in all cases. Histomorphometric analysis of the collected filters showed embolized debris in all patients. Acute thrombus was found in three patients, organizing thrombus in four. Interestingly, two patients had endocardial or myocardial tissue in their filters. CONCLUSIONS: Cerebral protection during iLAAO with the Sentinel CPS® device is feasible. Furthermore, this dataset identifies the formation and embolization of thrombus and cardiac tissue as emboligeneic sources and potential future targets to reduce procedural complications. © 2016 Wiley Periodicals, Inc.

"Shock and Go?" extracorporeal cardio-pulmonary resuscitation in the golden-hour of ROSC.

OBJECTIVES: The feasibility and outcomes of 35 consecutive patients subjected to eCPR in the tertiary cardiology center were investigated. BACKGROUND: While conventional cardiopulmonary-resuscitation (cCPR) often times achieves only mediocre outcomes extracorporeal cardiopulmonary-resuscitation (eCPR) increasingly shifts into the focus of interest. However, the scientific evidence for eCPR is sparse, particularly in the cardiological setting. METHODS: Retrospective chart analysis of 35 patients treated with eCPR between 01/2014 and 10/2015. RESULTS: The duration of cCPR until initiation of eCPR was 73.8 ± 37.6 min and resulted in an initial pH of 6.9 ± 0.2 and serum lactate level of 14.5 ± 4.8 mmol/L. About 62% (n = 22) of the patients suffered from out of hospital cardiac arrest (OHCA), 85% (n = 30) of the overall events were witnessed and bystander-CPR performed in 77% (n = 27) of cases. Cause of arrest was dominated by acute myocardial infarction (AMI, 71%), initial rhythm to a lesser degree by ventricular fibrillation/tachycardia (VF/VT, 57%). Almost all patients (n = 33, 94%) experienced return of spontaneous circulation (ROSC) after establishing extracorporeal life support (ECLS). In all 57% patients were successfully weaned from ECLS. Survival to discharge was 31% with predominantly good cerebral performance category (CPC 1-2). Survivors were more likely to receive bystander-CPR (P = 0.03) and the duration of cCPR until initiation of eCPR was significantly shorter (P = 0.004). CONCLUSIONS: Our data proves the exceptional level of efficiency of eCPR particularly when Bystander-CPR has been initiated and there is a short duration of cCPR. © 2016 Wiley Periodicals, Inc.

Treatment of acquired von Willebrand syndrome in aortic stenosis with transcatheter aortic valve replacement.

OBJECTIVES: This study sought to investigate the prevalence of abnormal von Willebrand multimers (AbM) in patients undergoing transcatheter aortic valve replacement (TAVR) and the impact of TAVR on the underlying factor variances. BACKGROUND: An association between the acquired von Willebrand syndrome (aVWS) and valvular aortic stenosis (AS) has been established in the past and surgical aortic valve replacement (SAVR) shown to lead to factor recovery. Prevalence and course of AbM in patients treated with TAVR though has not yet been described comprehensively. METHODS: Ninety-five consecutive patients underwent TAVR at our institution. Hemostaseologic testing was performed before and up to 1 week after TAVR. Transvalvular and right heart hemodynamics as well as bleeding episodes were recorded and analyzed with descriptive statistics. RESULTS: Baseline prevalence of AbM was 42% with an average high-molecular-weight multimer (HMWM) count of 16.2 ± 3.3%. Pressure gradients correlated significantly with the extent of HMWM deficiency (r = -0.63 [p < 0.0001]). Following valve implantation, HMWM increased proportional to the drop in mean pressure gradient and normalized in most of the patients. However, residual aortic regurgitation/leakage led to inferior HMWM recovery but prosthesis-patient mismatch (PPM) was rare and left HMWM uninfluenced. We saw no association of transfusion with AbM and 1-year mortality was unaffected by AbM. CONCLUSIONS: AbM in patients with AS undergoing TAVR is frequent. However, TAVR is capable of correcting AbM and therefore possibly aVWS in patients with AS. As opposed to SAVR, bleeding and transfusion requirement in TAVR patients was not associated with severe HMWM deficiency; PPM was rare and HMWM were uninfluenced by the procedure. Aortic regurgitation after TAVR adversely influenced HMWM recovery.

Differential diagnosis of a fulminant myocarditis: the pheochromocytoma crisis.

Concurring left ventricular dysfunction, pulmonary edema and febrile temperature in otherwise healthy young individuals often constitutes the clinical presentation of a fulminant myocarditis. Nevertheless, the pheochromocytoma crisis (PCC) can mimic this very cluster of symptoms, camouflaging its disclosure. We describe a dramatic case of pheochromocytoma crisis mimicking fulminant myocarditis.