Identifikation klinischer Faktoren zur optimierten Patientenselektion bei interventioneller Therapie der Mitralklappeninsuffizienz mittels MitraClip Device

Der MitraClip (Abbott-Laboratories) ist eine katheterbasierte Therapieoption bei schwerer Mitralklappeninsuffizienz (MI) und hohem OP-Risiko. Die progrediente Klinik der MI erschwert jedoch die Identifikation des optimalen Interventionszeitpunktes. Publikation 1 untersuchte daher, ob symptomatische Patienten mit in Ruhe moderater, unter Handgrip-Stressechokardiographie jedoch schwerer MI (MI2+) gegenüber Patienten mit bereits in Ruhe schwerer MI (MI3) bessere MitraClip-Ergebnisse zeigten. Ein weiteres wichtiges klinisches Szenario sind koinzidente moderate Aortenklappenerkrankungen. Publikation 2 untersuchte deren Beeinflussung des MitraClip-Outcomes. Trotz erfolgreichem MitraClip erleiden einige Patienten ein MI-Rezidiv, weshalb Publikation 3 Machbarkeit und Ergebnisse eines Re-MitraClip (ReClip) untersuchte. Material und Methodik Publikation 1 verglich retrospektiv 55 MI2+ Patienten mit 166 MI3 Patienten bezüglich eines kombinierten Endpunktes (Mortalität, Herzinsuffizienz-Hospitalisationen) 2 Jahre nach MitraClip, Publikation 2 verglich 21 Patienten mit koinzidenter moderater Aortenklappenstenose (AS), 28 Patienten mit moderater Aortenklappeninsuffizienz (AI) und 237 Patienten ohne relevante Aortenklappenerkrankung 1 Jahr nach MitraClip und Publikation 3 untersuchte das Outcome 1 Jahr nach 15 ReClip-Prozeduren. Ergebnisse MI3 Patienten zeigten gegenüber MI2+ Patienten signifikant höhere STS-Scores, mehr präprozedurale Herzinsuffizienz-Hospitalisationen, schlechtere linksventrikuläre (LV) Ejektionsfraktionen und verstärkte LV-Dilatation (Publikation 1). MI3 Patienten erlitten nach 2 Jahren signifikant häufiger den kombinierten Endpunkt (p=0,010). Herzinsuffizienz-Hospitalisationen waren jedoch in beiden Gruppen gegenüber den 2 präprozeduralen Jahren reduziert (MI3: p<0,001; MI2+: p=0,030). Präprozedurale Herzinsuffizienz-Hospitalisationen (Hazard-Ratio[HR]: 1,813; p=0,040) sowie verstärkte LV-Dilatation (HR: 1,035; p=0,020) prädizierten schlechteres Outcome. Patienten mit koinzidenter moderater AS/AI zeigten bezüglich des kombinierten Endpunkts nach 1 Jahr keinen signifikanten Unterschied (Publikation 2). Allerdings zeigten AI-Patienten signifikant erhöhte Mortalitätsraten (17,9% vs. 5,0% bei AS vs. 3,8% ohne Aortenklappenerkrankung, p=0,006). AS-Patienten zeigten gegenüber Patienten ohne relevante Aortenklappenerkrankung signifikant häufiger residuelle MI>2 (14,3% vs. 8,9%, p=0,001). 11 der 15 ReClips (73%) waren erfolgreich (MI-Reduktion≥1, Mitralklappengradient<5mmHg), wobei keinerlei Komplikationen auftraten (Publikation 3). 1 Jahr nach ReClip zeigten 2 Patienten erneute MI-Rekurrenz (Erfolgsrate nun 60%). Tendenziell schlechteres Outcome hatten Patienten mit geringerer Koaptationstiefe und höherem Klappengradienten vor ReClip. Schlussfolgerungen Patienten mit symptomatischer MI, in Ruhe moderat, progredient unter Handgrip, sind wahrscheinlich an einem früheren Erkrankungszeitpunkt mit einem möglicherweise besseren MitraClip-Ansprechen (Publikation 1). Diese dynamische MI-Komponente, eventuell ein guter übergreifender Identifikator eines geeigneten Therapiezeitpunkts, sollte daher in die Patientenevaluation einfließen. Patienten mit moderater-AS sollten eine genaue Mitralklappenpathologie Analyse erhalten, um technische Erfolgsaussichten (MI-Reduktion) abzuschätzen. Patienten mit moderater-AI sollten aufgrund des Mortalitätssignals eine präzise AI-Schweregrad Evaluation sowie eine kritische Diskussion der Therapiemöglichkeiten erfahren (Publikation 2). ReClip erscheint als sichere Behandlungsoption mit guten Erfolgsaussichten, es sollte jedoch eine genaue Patientenauswahl (Koaptationstiefe und Klappengradient beachtend) erfolgen. Aufgrund der retrospektiven Betrachtungsweise sowie teilweise geringer Patientenzahlen sollten größere Studien diese Ergebnisse validieren.MitraClip (Abbott-Laboratories) is a catheter-based treatment for high surgical-risk patients with severe mitral regurgitation (MR). During MR progression, identification of an ideal treatment-point is challenging. Thus, publication 1 studied whether patients with moderate resting MR, progressing to severe under handgrip-exercise (MR2+) showed better outcomes than patients with severe resting MR (MR3). As concomitant aortic-valve-diseases (AVD) are another field of concern, publication 2 studied how these influence MitraClip outcomes. Despite successful MitraClip some patients experience MR recurrence. Publication 3 evaluated feasibility and outcomes of Re-MitraClip (ReClip) in such patients. Material and methods Publication 1 retrospectively compared 55 MR2+ with 166 MR3 patients, assessing a combined endpoint (mortality, heart-failure[HF]-hospitalisations) 2 years after MitraClip. Publication 2 compared 21 patients with concomitant moderate aortic-stenosis (AS), 28 patients with concomitant moderate aortic-regurgitation (AR) and 237 patients without AVD 1 year following MitraClip. Publication 3 studied outcomes in 15 patients 1 year after ReClip. Results MR3 patients compared with MR2+ showed significantly higher STS-Scores, more pre-procedural HF-hospitalisations, worse leftventricular (LV) ejection fraction und more LV-dilatation (publication 1). MR3 patients after 2 years significantly more often experienced the combined endpoint (p=0,010). HF-hospitalisations, compared to 2 years pre-procedure, were reduced in both groups (MR3: p<0,001; MR2+: p=0,030). Pre-procedural HF-hospitalisations (Hazard-Ratio [HR]: 1,813; p=0.040) and LV-dilatation (HR: 1,035; p=0,020) predicted worse outcome. Concomitant AS/AR patients after 1 year showed no differences concerning the combined endpoint (publication 2). However, AR patients showed significantly higher mortality (7,9% vs. 5,0% in AS vs. 3,8% without AVD, p=0,006). AS patients compared with no-AVD patients had more residual MR>2 (14,3% vs. 8,9%, p=0,001). 11 of 15 ReClips (73%) were successful (MR-reduction≥1, gradient<5mmHg), without complications (publication 3). 1 year after ReClip, 2 patients again had MR recurrence (resulting success-rate 60%). Patients with less coaptation-depth and higher gradients before ReClip tended to worse outcomes. Conclusions Patients with symptomatic MR, moderate at rest, progressing to severe under handgrip, probably are at an earlier disease-stage, promising better MitraClip response (publication 1). This exercise-increase in MR might be a good marker of an effective treatment point and should be assessed during patient evaluation. In moderate AS patients, MR-mechanism should be studied precisely to judge chances of technical success (MR-reduction). Moderate AR patients, given the mortality findings, should receive detailed grading of AR-severity and thorough discussion of treatment options. ReClip appears as safe treatment with good success-rates, when patients are chosen carefully (respecting coaptation-depth and gradient). Given the retrospective design and small numbers in some sub-groups, larger studies should validate these results

Update on the Current Landscape of Transcatheter Options for Tricuspid Regurgitation Treatment

Most patients with severe tricuspid regurgitation lack treatment options because of prohibitive surgical risk. New transcatheter treatments under development and investigation might be able to address this unmet clinical need. This article gives an update on the landscape of devices for transcatheter tricuspid regurgitation treatment including different approaches (i.e. repair with leaflet approximation or annuloplasty and replacement using orthotopic or heterotopic valves) at different stages of development, from experimental to clinical trial. Repair devices such as the Cardioband or the MitraClip are leading the field with promising preliminary data and further trials are ongoing. However, with implantations of the Gate bioprosthesis, replacement devices are catching up. Potential advantages of different approaches and most recent data are discussed

Transcatheter Mitral Valve Replacement: Current Evidence and Concepts

Over the past decade, several transcatheter devices have been developed to address the treatment of severe mitral regurgitation (MR) in patients at high surgical risk, mainly aimed at repairing the native mitral valve (MV). MV repair devices have recently been shown to have high efficacy and safety. However, to replicate promising trial results, specific anatomical and pathophysiological criteria have to be met and operators need a high level of experience. As yet, the longer-term durability of transcatheter MV repair remains unknown. Transcatheter MV replacement (TMVR) might be a treatment option able to target various anatomies, reliably abolish MR, and foster ease of use with a standardised implantation protocol. This review presents upcoming TMVR devices and available data and discusses how TMVR might further advance the field of transcatheter treatment of MR

The predictive value of a modified Carpentier classification in patients with coincidental mitral regurgitation undergoing TAVI for severe aortic valve stenosis1

INTRODUCTION Concomitant mitral-regurgitation (MR) is frequently observed in patients undergoing trans-catheter aortic valve implantation (TAVI). The predictive value of MR etiology remains to be elucidated. METHODS 600 patients with coincidental MR (≥moderate) undergoing TAVI were categorized according to a modified Carpentier classification [Groups: no/mild MR, n = 477; left atrial (LA) functional MR, n = 18; MR due to left ventricular dilatation, n = 29; degenerative MR, n = 50; MR with restricted leaflet motion n = 26]. MR improvement and patient outcome was compared among the groups in a retrospective analysis. RESULTS MR regression was most pronounced in patients with restricted leaflet motion after 6 months, although a significant improvement was observed in all subgroups. MR relief was predominantly observed within the first 30 days after TAVI. Only patients with restricted leaflet motion experienced further improvement thereafter.In the entire cohort a total of 15 strokes (2.5%) during the first 30 days after TAVI were observed, with the highest incidence in the LA functional cohort (3 events, 17%; p = 0.008). In multivariate analysis, organic etiology was associated with an increased 1-year mortality.In conclusion, despite significant MR regression in all MR groups, some individuals may require additional mitralvalve repair after TAVI. According to our data the timing of these procedures should be based on the underlying MR etiology. The Carpentier classification in patients with coincidental MR undergoing TAVI for severe AS may also have prognostic implications as we found an increased incidence of strokes in our LA functional cohort and a worse mortality rates in organic MR

The BCI Competition 2003: Progress and Perspectives in Detection and Discrimination of EEG Single Trials

Interest in developing a new method of man-tomachine communication---a brain-computer interface or BCI--- has grown steadily over the past few decades. BCIs create a new communication channel between the brain and an output device by bypassing conventional motor output pathways of nerves and muscles. These systems use signals recorded from the scalp, the surface of the cortex, or from inside the brain to enable users to control a variety of applications including simple word-processing software and orthotics. BCI technology could therefore provide a new communication and control option for individuals who cannot otherwise express their wishes to the outside world. Signal processing and classification methods are essential tools in the development of improved BCI technology. We organized the BCI Competition 2003 to evaluate the current state of the art of these tools. Fou