Kathetertechnischer Restshuntverschluss nach Implantation verschiedener Systeme zur Okklusion des persistierenden Foramen ovale / vorgelegt von Nicolas Kurt Geza Majunke

Der katheterinterventionelle Verschluss des persistierenden Foramen ovale ist heutzutage ein sicher durchzuführender Eingriff zur Sekundärprophylaxe einer paradoxen Embolie. Mit den derzeit zur Verfügung stehenden Verschlusssystemen werden komplette Verschlussraten von 86 % – 96 % erreicht. Mehrere Studien konnten zeigen, dass das Vorliegen eines Restshunts das Auftreten von erneuten paradoxen Embolien begünstigt. Mehrere Therapieoptionen für Patienten mit Restshunt stehen zur Verfügung: eine Operation mit Entfernung des PFO-Okkluders und Naht- oder Patchverschluss des PFO, eine medikamentöse Prophylaxe mit Thrombozytenaggregationshemmern oder oralen Antikoagulanzien sowie die Implantation eines zweiten Okkluders. Ziel dieser Arbeit war die Beurteilung der Wirksamkeit und Sicherheit der perkutanen Implantation eines zweiten Verschlusssystems bei Patienten mit mittlerem oder großem Restshunt. Zwischen Oktober 1997 und April 2008 wurde in unserem Zentrum bei 40 Patienten mit einem durchschnittlichen Alter von 51 ± 13 Jahren der katheterinterventionelle Verschluss eines Restshunts mit verschiedenen Verschlusssystemen versucht. Von den Patienten waren 22 weiblich und 18 männlich. Die Implantation eines zweiten Okkluder war bei 39 Patienten erfolgreich (98%). Nur bei einem Patienten war es nicht möglich den Restdefekt mit einem Katheter zu sondieren. Folgende Schirme wurden als Zweitokkluder implantiert: ein Premere-Okkluder bei 20 Patienten (51%), ein Amplatzer-Okkluder bei 13 Patienten (33%), ein STARFlex-Okkluder bei vier Patienten (10%), ein Helex-Okkluder bei einem Patienten (2,5%) und ein Angelwings-Okkluder bei einem Patienten (2,5%). Die mittlere Durchleuchtungszeit aller Eingriffe betrug 8,6 ± 8,6 Minuten. Während der Eingriffe und innerhalb von 30 Tagen nach Implantation eines zweiten Okkluders traten keine Komplikationen auf. Die Patienten wurden im Mittel 36 ± 29 Monate nachbeobachtet. In dieser Zeit wurde bei allen Patienten mindestens sechs Monate nach dem Eingriff eine transösophageale Echokardiographie mit Shuntdiagnostik durchgeführt. Hierbei zeigte sich bei 27 von 39 Patienten (69%) ein kompletter Verschluss des PFO. Bei neun Patienten verblieb nur noch ein kleiner Restshunt, bei einem Patienten ein mittlerer Restshunt und bei weiteren zwei Patienten ein großer Restshunt. Der Patient mit mittlerem Restshunt und ein Patient mit einem großen Restshunt erhielten einen dritten Okkluder. Letzterer verstarb 21 Tage nach Implantation des dritten Okkluders an einer akuten Perikardtamponade. Eine Patientin mit großem Restshunt entschied sich für eine Operation. Neben dem oben beschriebenen Todesfall nach Implantation eines dritten Okkluders traten während des ganzen Nachbeobachtungszeitraums keine weiteren Komplikationen auf. Diese Arbeit zeigt, dass die perkutane Implantation eines zweiten PFO-Okkluders sicher und technisch problemlos möglich ist. Ein kompletter Verschluss konnte in der Mehrzahl der Patienten erreicht werden. Außer einem Todesfall durch eine akute Perikardtamponade nach Implantation eines dritten Okkluders traten sowohl während den Eingriffen als auch im weiteren Verlauf keine Komplikationen auf.To date, percutaneous closure of patent foramen ovale has become a safe procedure for secondary prevention of recurrent paradoxical embolism. Complete closure rates with current devices range from 86% - 96%. Several studies have shown an increased risk of recurrent paradoxical embolism in patients with a residual shunt after transcatheter PFO closure than in patients with complete closure of the PFO. Patients with residual shunt following percutaneous PFO closure can be treated with antiplatelet or anticoagulation drugs, surgery with device removal and closure of the PFO or percutaneous implantation of a second closure device. This study investigated the safety and feasibility of transcatheter closure in patients with a moderate or large residual shunt after percutaneous PFO closure. Between October 1997 and June 2008 implantation of a second closure device was attempted in 40 patients with a mean age of 51 ± 13 years. 22 of the patients were female and 18 were male. Implantation of a second occluder was successful in 39 patients (98%). In 1 patient with a moderate residual shunt it was not possible to cross the septum and a second device was not implanted. The following devices were used as a second closure device: the Premere device was implanted in 20 patients (51%), the Amplatzer PFO occluder was used in 13 patients (3%), a STARFlex occluder was implanted in four patients (10%), a Helex device in one patient (2.5%), and an Angelwings device in one patient (2.5%). The mean fluoroscopy time was 8.6 ± 8.6 min. Neither during nor 30 days after the procedure any complications occurred. A mean follow-up of 36 ± 29 months after implantation of a second device is available in all patients. A TEE examination with shunt diagnostic was performed in all patients at least six months after the procedure and showed complete closure of the PFO in 27 patients (69 %). A small residual shunt remained in nine, a moderate residual shunt in one and a large residual shunt in two patients. In one patient with a moderate residual shunt a third closure device was implanted. A TEE six months later showed only a small residual shunt. One patient with a large residual shunt received a third occluder. This patient died 21 days after implantation of the third device due to an acute pericardial tamponade. The second patient with a large residual shunt declined to be treated with a third closure device and was sent to surgery. Both PFO devices were retrieved and the PFO was closed with a Patch. Surgery was uneventful. No complications, except for the pericardial tamponade described above, occurred during follow-up. This analysis shows that implantation of a second PFO closure device is technically feasible. The complete closure rate is lower than after closure of a native PFO. There were no procedural complications. During follow-up one patient died due to an acute pericardial tamponade after implantation of a third closure device. No further complications were observed during follow-up

Hypertrophic, Dilated, and Arrhythmogenic Cardiomyopathy: Where Are We?

Cardiomyopathies are a heterogeneous group of structural, mechanical, and electrical heart muscle disorders which often correlate with life-threatening arrhythmias and progressive heart failure accounting for significant cardiovascular morbidity and mortality. Currently, cardiomyopathies still represent a leading reason for heart transplantation worldwide. The last years have brought remarkable advances in the field of cardiomyopathies especially in terms of understanding the molecular basis as well as the diagnostic evaluation and management. Although most cardiomyopathy treatments had long focused on symptom management, much of the current research efforts aim to identify and act on the disease-driving mechanisms. Regarding risk assessment and primary prevention of sudden cardiac death, additional data are still pending in order to pave the way for a more refined and early patient selection for defibrillator implantation. This review summarizes the current knowledge of hypertrophic, dilated and arrhythmogenic cardiomyopathy with a particular emphasis on their pathophysiology, clinical features, and diagnostic approach. Furthermore, the relevant ongoing studies investigating novel management approaches and main gaps in knowledge are highlighted

Extracorporeal Membrane Oxygenation in Infarct-Related Cardiogenic Shock

Mortality in infarct-related cardiogenic shock (CS) remains high, reaching 40–50%. In refractory CS, active mechanical circulatory support devices including veno-arterial extracorporeal membrane oxygenation (VA-ECMO) are rapidly evolving. However, supporting evidence of VA-ECMO therapy in infarct-related CS is low. The current review aims to give an overview on the basics of VA-ECMO therapy, current evidence, ongoing trials, patient selection and potential complications

Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies

Background: Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial. Aims: We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide). Methods: We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately. Results: Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43–0.89], p = 0.01, I2 = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16–2.51], p = 0.01, I2 = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32–1.02], p = 0.06, I2 = 70%; and RCT: RR 1.37 [95%CI 0.82–2.28], p = 0.23, I2 = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07–11.33], p = 0.04, I2 = 0%). Conclusions: While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique. Graphical abstract: [Figure not available: see fulltext.]

Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder)

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3+/-1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder