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"Geidel, Stephan"
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The role of hemoadsorption in cardiac surgery – a systematic review
2024
Background
Extracorporeal blood purification has been widely used in intensive care medicine, nephrology, toxicology, and other fields. During the last decade, with the emergence of new adsorptive blood purification devices, hemoadsorption has been increasingly applied during CPB in cardiac surgery, for patients at different inflammatory risks, or for postoperative complications. Clinical evidence so far has not provided definite answers concerning this adjunctive treatment. The current systematic review aimed to critically assess the role of perioperative hemoadsorption in cardiac surgery, by summarizing the current knowledge in this clinical setting.
Methods
A literature search of PubMed, Cochrane library, and the database provided by CytoSorbents was conducted on June 1st, 2023. The search terms were chosen by applying neutral search keywords to perform a non-biased systematic search, including language variations of terms “cardiac surgery” and “hemoadsorption”. The screening and selection process followed scientific principles (PRISMA statement). Abstracts were considered for inclusion if they were written in English and published within the last ten years. Publications were eligible for assessment if reporting on original data from any type of study (excluding case reports) in which a hemoadsorption device was investigated during or after cardiac surgery. Results were summarized according to sub-fields and presented in a tabular view.
Results
The search resulted in 29 publications with a total of 1,057 patients who were treated with hemoadsorption and 988 control patients. Articles were grouped and descriptively analyzed due to the remarkable variability in study designs, however, all reported exclusively on CytoSorb
®
therapy. A total of 62% (18/29) of the included articles reported on safety and no unanticipated adverse events have been observed. The most frequently reported clinical outcome associated with hemoadsorption was reduced vasopressor demand resulting in better hemodynamic stability.
Conclusions
The role of hemoadsorption in cardiac surgery seems to be justified in selected high-risk cases in infective endocarditis, aortic surgery, heart transplantation, and emergency surgery in patients under antithrombotic therapy, as well as in those who develop a dysregulated inflammatory response, vasoplegia, or septic shock postoperatively. Future large randomized controlled trials are needed to better define proper patient selection, dosing, and timing of the therapy.
Journal Article
Intraoperative haemoadsorption for antithrombotic drug removal during cardiac surgery: initial report of the international safe and timely antithrombotic removal (STAR) registry
2024
Intraoperative antithrombotic drug removal by haemoadsorption is a novel strategy to reduce perioperative bleeding in patients on antithrombotic drugs undergoing cardiac surgery. The international STAR registry reports real-world clinical outcomes associated with this application. All patients underwent cardiac surgery before completing the recommended washout period. The haemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit. Patients on P2Y12 inhibitors comprised group 1, and patients on direct-acting oral anticoagulants (DOAC) group 2. Outcome measurements included bleeding events according to standardised definitions and 24-hour chest-tube-drainage (CTD). 165 patients were included from 8 institutions in Austria, Germany, Sweden, and the UK. Group 1 included 114 patients (62.9 ± 11.6years, 81% male) operated at a mean time of 33.2 h from the last P2Y12 inhibitor dose with a mean CPB duration of 117.1 ± 62.0 min. Group 2 included 51 patients (68.4 ± 9.4years, 53% male), operated at a mean time of 44.6 h after the last DOAC dose, with a CPB duration of 128.6 ± 48.4 min. In Group 1, 15 patients experienced a BARC-4 bleeding event (13%), including 3 reoperations (2.6%). The mean 24-hour CTD was 651 ± 407mL. In Group 2, 8 patients experienced a BARC-4 bleeding event (16%) including 4 reoperations (7.8%). The mean CTD was 675 ± 363mL. This initial report of the ongoing STAR registry shows that the intraoperative use of a haemoadsorption device is simple and safe, and may potentially mitigate the expected high bleeding risk of patients on antithrombotic drugs undergoing cardiac surgery before completion of the recommended washout period.Clinical registration number: ClinicalTrials.gov identifier: NCT05077124.
Journal Article
Removal of Apixaban during Emergency Cardiac Surgery Using Hemoadsorption with a Porous Polymer Bead Sorbent
by
Wendt, Daniel
,
Deliargyris, Efthymios
,
Geidel, Stephan
in
Anticoagulants
,
Cardiovascular disease
,
Chest tubes
2022
Background: Patients on direct oral anticoagulants are at high risk of perioperative bleeding complications. We analyzed the results of intraoperative hemoadsorption (HA) in patients undergoing cardiac surgery who were also on concurrent therapy with apixaban. Methods: we included 25 consecutive patients on apixaban who underwent cardiac surgery with the use of cardio-pulmonary bypass (CPB) at three sites. The first 12 patients underwent surgery without hemoadsorption (controls), while the next 13 consecutive patients were operated with the Cytosorb® (Princeton, NJ, USA) device integrated into the CPB circuit (HA group). The primary outcome was perioperative bleeding assessed by the Bleeding Academic Research Consortium (BARC) definition and secondary outcomes included 24 h chest-tube-drainage (CTD) and need for 1-deamino-8-d-arginine-vasopressin (desmopressin (DDAVP)) administration to achieve hemostasis. Results: Preoperative mean daily dose of apixaban was higher in the HA group (8.5 ± 2.4 vs. 5.6 ± 2.2 mg, p = 0.005), while time since last apixaban dose was longer in the controls (1.3 ± 0.9 vs. 0.6 ± 1.2 days, p < 0.001). No BARC-4 bleeding events and no repeat-thoracotomies occurred in the HA group compared with 3 and 1, respectively, in the controls. Postoperative 24 h CTD volume was significantly lower in the HA group (510 ± 152 vs. 893 ± 579 mL, p = 0.03) and there was no need for DDAVP compared to controls, who received an average of 10 ± 13.6 mg (p = 0.01). Conclusions: In patients on apixaban undergoing emergent cardiac surgery, the intraoperative use of hemoadsorption was feasible and safe. Compared to patients operated on without hemoadsorption, BARC-4 bleeding complications did not occur and the need for 24 h CTD and DDAVP was significantly lower.
Journal Article
A case report of a late left atrial appendage perforation 4 months after occluder implant: reason for or caused by a resuscitation?
by
Geidel, Stephan
,
Schenke, Karsten
,
Keller, Christian
in
Case Reports
,
Coronary vessels
,
Stroke
2019
Abstract
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.
Journal Article
Percutaneous approaches for mitral valve interventions--a real alternative technique for standard cardiac surgery?
by
Malisius, Rainer
,
Geidel, Stephan
,
Schäfer, Ulrich
in
Heart Valve Prosthesis
,
Heart Valve Prosthesis Implantation - instrumentation
,
Humans
2009
Standard therapy of advanced mitral valve regurgitation currently consists of mitral valve reconstruction through heart surgery including heart-lung machine employment. Typically, a ring is implanted and a leaflet reduced, if necessary, to approximate the posterior and anterior mitral valve leaflets to each other. Because of high comorbidity among this patient population, new and less burdening catheter-based techniques have been developed. Clinical etiology of mitral valve regurgitation is divided into two categories: \"structural\" versus \"functional\". The MONARC system of the Edwards Lifesciences company consists of three components--distal stent, bridge with bioabsorbing coating, proximal stent--and is implanted into the coronary sinus. The underlying principle is an indirect annuloplasty of the mitral valve annulus resulting from resorption of the bridge coating and leading to a reduction and indirect tightening of the mitral valve annulus. The EVOLUTION I (EV I) study in patients suffering from functional mitral regurgitation to a degree between 2+ and 4+ revealed--12 months after the MONARC implantation--a mitral valve regurgitation reduction from 2.48 to 1.78. The EV I study found interaction of the foreshortening bridge with the coronary arteries in some patients. This problem is most widely excluded by previous computed tomographic or angiographic examinations in the ongoing follow-up study EV II. Direct annuloplasty is made possible in case of functional mitral regurgitation by using the Mitralign Percutaneous Annuloplasty System (MPAS) of the Mitralign company. In doing so, an improved coadaptation of the mitral valve leaflet is achieved by inserting three sutures into the posterior mitral valve annulus and subsequent plicating.The MitraClip of the Evalve company uses the principle of the edge-to-edge technique. In doing so, the posterior and anterior leaflets are joined by implanting a clip, resulting in a reduction of mitral regurgitation with two diastolic orifices. In contrast to strukthe other two procedures, the MitraClip can be used for both functional and structural mitral valve regurgitation. The EVEREST I study and the EVEREST II study, as far as it has already been published, show that this procedure is secure and its results are very positive. The previous results of all three procedures show that catheter-based techniques for treating high-risk patients suffering from mitral valve regurgitation arrive at positive results in part, so that possibly a real alternative to conventional heart surgery will be available in the future.
Journal Article
Die perkutane Mitralklappenintervention bei Mitralklappeninsuffizienz – eine Alternative zur konventionellen Herzchirurgie?
by
Malisius, Rainer
,
Geidel, Stephan
,
Schäfer, Ulrich
in
Cardiology
,
Internal Medicine
,
Medicine
2009
Zusammenfassung
Die bisherige Standardtherapie der fortgeschrittenen Mitralklappeninsuffizienz besteht in der herzchirurgischen Mitralklappenrekonstruktion mit Implantation eines Rings und ggf. Kürzung eines Segels zur Annäherung des posterioren und des anterioren Mitralklappensegels. In diesem Patientenkollektiv besteht jedoch häufig eine hohe Komorbidität, so dass neue, weniger belastende katheterbasierte Techniken entwickelt werden. Die EVOLUTION-I-Studie mit Implantation des MONARC
®
-Systems der Firma Edwards Lifesciences in den Koronarvenensinus zur indirekten Mitralklappenanuloplastie bei Patienten mit funktioneller Mitralklappeninsuffizienz zeigte nach 12 Monaten eine Reduktion der Mitralinsuffizienz von 2,48 auf 1,78. Eine direkte Anuloplastie bei funktioneller Mitralinsuffizienz ist mittels des MPAS
®
der Firma Mitralign möglich. Hierbei wird durch Insertion von drei Fäden in den posterioren Mitralklappenanulus und folgende Plikation eine verbesserte Koadaptation der Mitralklappensegel erreicht. Der MitraClip
®
der Firma Evalve bedient sich des Prinzips der „edge-toedge“- Technik. Hierbei werden das posteriore und das anteriore Segel durch Implantation einer Klammer zusammengefügt, so dass eine Reduktion der Mitralinsuffizienz mit diastolisch zwei Öffnungen resultiert.
Die bisherigen Resultate zeigen, dass katheterbasierte Techniken zur Behandlung der Mitralklappeninsuffizienz mit z.T. guten Ergebnissen bei Hochrisikopatienten möglich sind, so dass zukünftig möglicherweise eine echte Alternative zur konventionellen Herzchirurgie zur Verfügung steht.
Journal Article
The DZHK research platform: maximisation of scientific value by enabling access to health data and biological samples collected in cardiovascular clinical studies
by
Wichmann, Heinz-Erich
,
Hasenfuß, Gerd
,
Wachter, Rolf
in
Biobanks
,
Biological properties
,
Biological samples
2023
The German Centre for Cardiovascular Research (DZHK) is one of the German Centres for Health Research and aims to conduct early and guideline-relevant studies to develop new therapies and diagnostics that impact the lives of people with cardiovascular disease. Therefore, DZHK members designed a collaboratively organised and integrated research platform connecting all sites and partners. The overarching objectives of the research platform are the standardisation of prospective data and biological sample collections among all studies and the development of a sustainable centrally standardised storage in compliance with general legal regulations and the FAIR principles. The main elements of the DZHK infrastructure are web-based and central units for data management, LIMS, IDMS, and transfer office, embedded in a framework consisting of the DZHK Use and Access Policy, and the Ethics and Data Protection Concept. This framework is characterised by a modular design allowing a high standardisation across all studies. For studies that require even tighter criteria additional quality levels are defined. In addition, the Public Open Data strategy is an important focus of DZHK. The DZHK operates as one legal entity holding all rights of data and biological sample usage, according to the DZHK Use and Access Policy. All DZHK studies collect a basic set of data and biosamples, accompanied by specific clinical and imaging data and biobanking. The DZHK infrastructure was constructed by scientists with the focus on the needs of scientists conducting clinical studies. Through this, the DZHK enables the interdisciplinary and multiple use of data and biological samples by scientists inside and outside the DZHK. So far, 27 DZHK studies recruited well over 11,200 participants suffering from major cardiovascular disorders such as myocardial infarction or heart failure. Currently, data and samples of five DZHK studies of the DZHK Heart Bank can be applied for.
Journal Article