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Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4–8%) as well as in low-risk patients (STS-Score

We aimed to detect alterations and deficits in hemostasis during cardiac surgery with cardiopulmonary bypass (CPB) using point-of-care-supported coagulation analysis (rotational thromboelastometry, impedance aggregometry), in addition to single factor assays for the measurement of fibrinogen (FI) and factor XIII (FXIII) levels. Forty-one patients scheduled for elective cardiac surgery with CPB were enrolled in this observational study. Perioperative measurement (pre-, postheparin, 30-minutes before the end of bypass, 1-hourpostoperatively) of standard laboratory variables, additional rotational thromboelastometry (ROTEM; International GmbH, Munich, Germany), Multiplate analysis (Roche, Switzerland), and an assay of FXIII activity were performed as well as the collection of epidemiological data and blood loss. The FI and FXIII levels as well as the measured ROTEM and Multiplate parameters correlated weakly with the blood loss. Clotting time and maximum clot firmness (MCF) of the intrinsically activated ROTEM showed a good correlation ( rCT-INTEM = 0.378; P < .05, rMCF-INTEM = 0.305; P < .05) with postoperative drainage loss, suggesting a dependence of blood loss on the initial intrinsic activity. Additionally, perioperative FI or FIBTEM levels and the FXIII levels correlated with each other. Intrinsically activated ROTEM showed a good correlation with postoperative drainage loss, thus suggesting a dependence of blood loss on the initial intrinsic activity and therefore facilitating clinicians to assess postoperative bleeding complications. Based on the FI level or the MCFFIBTEM measured by ROTEM, it may also be possible to assess the FXIII concentration. Especially in chronically ill and massive bleeding cardiac surgery patients with significantly decreased FXIII levels, the knowledge of FXIII deficiency may help clinicians to treat coagulation disorders more adequately.

Seit die perkutane Aortenklappenimplantation klinische Routine fur Hochrisikopatienten geworden ist, ruckt die interventionelle Therapie der Mitralklappeninsuffizienz (MI) weiter in den Fokus klinischer Forschung. Rekonstruktionsverfahren, wie Edge-to-Edge-Plastik, direkte und indirekte Anuloplastie sowie transapikale Sehnenfadenimplantation, haben bereits die Communaute-Europeenne(CE)-Zulassung erhalten, werden klinisch implantiert und vergutet, lassen sich jedoch nicht auf alle Patienten mit MI anwenden. Neben weiteren innovativen kathetergestutzten Rekonstruktionstherapien wurden Systeme zur „transcatheter mitral valve implantation“ (TMVI) entwickelt und sind in klinischer Prufung. Der vorliegende Beitrag gibt einen Uberblick zur praoperativen Vorbereitung, diskutiert Vor- und Nachteile von TMVI im Vergleich zu Rekonstruktionsverfahren und beschreibt die bereits bestehende Erfahrung mit einzelnen Prothesentypen. Erste Machbarkeitsstudien zeigen hohere Komplikationsraten als bei den interventionellen Rekonstruktionen, jedoch eine effektivere Behandlung der MI. Bei TMVI handelt es sich um zusatzliche Therapieoptionen fur Patienten, die sich nicht fur konventionelle chirurgische Verfahren eignen. Die Entscheidung zwischen TMVI und interventionellen Rekonstruktionsverfahren sollte unter Abwagung aller patientenspezifischen Kriterien im Heart-Team aus interventionell tatigen Kardiologen und Herzchirurgen getroffen werden. Fur die Auswahl des richtigen Therapieverfahrens sind ein praoperatives EKG-getriggertes CT sowie eine transosophageale Echokardiographie (TEE) unumganglich. Wird TMVI favorisiert, stehen insgesamt 6 Prothesentypen zur Auswahl, die im Rahmen von Studien implantiert werden.

Objectives Transcatheter Aortic Valve Implantation (TAVI) can be performed via the transaxillary approach, but data about complications and procedural outcome is limited. Introduction TAVI is an established treatment option for patients at high risk for conventional aortic valve replacement. Nowadays, the transfemoral approach is the most commonly used access for TAVI. Nevertheless, the transfemoral access is not suitable in many patients necessitating alternative approaches. Methods We analyzed the outcome of 100 consecutive cases receiving percutaneous transaxillary TAVI at two different hospitals. Data were retrospectively analyzed by means of procedural, hemodynamic and clinical outcome. In addition, 1st versus 2nd generation devices were analyzed. Results Mean age was 78.2±2.1years and the logEuroSCORE I was 24.6±13.9%. Transaxillary TAVI was performed in 85% via the left and in 15% via the right axillary artery. Device success was achieved in 95%. In general, there was a clear learning curve with this approach. No patient experienced a major and 11% a minor access site complication. There was one procedural death (annular rupture) and one peri-procedural TIA. 23% of the patients received a new pacemaker. At discharge, effective orifice area was 1.94±0.16cm 2 and the mean aortic gradient was 6.8±2.1mmHg. Moderate aortic regurgitation/paravalvular leakage was documented in two patients. Mortality rates at 30days and one year were 6% and 14.8%. Last but not least, 2nd generation devices showed improved procedural outcomes. Conclusions The percutaneous transaxillary access for TAVI is technically feasible and safe thereby yielding excellent clinical results. Condensed abstract We investigated In 100 consecutive patients undergoing percutaneous transaxillary transcatheter aortic valve implantation thereby demonstrating that this approach is technically feasible and safe with acceptable numbers of minor vascular complications.

Die Einfuhrung der Transkatheter-Aortenklappenimplantation in die klinische Praxis hat die Behandlung alterer und Hochrisikopatienten mit Aortenklappenstenose revolutioniert. Die Ausweitung der Indikation auf Patienten mit niedrigerem operativen Risiko wird viel diskutiert – jedoch u. a. wegen der potenziellen neurologischen Komplikationen kritisch betrachtet. Vor allem die hohe Inzidenz an subklinischen Infarkten ist in diesem Zusammenhang kritisch. Die Anwendung perkutan implantierbarer, zerebraler Protektionssysteme als „Filter“ oder „Deflektoren“ hat in ersten klinischen Studien vielversprechende Ergebnisse gezeigt. Grosere Studien und Metaanalysen konnten eine Verringerung der Gesamthaufigkeit zerebraler Ischamien jedoch nicht bestatigen. Diese ergaben lediglich eine signifikante Reduktion der Lasionsvolumina und somit eine geringere Haufigkeit an neurokognitiven Symptomen. Gleichzeitig waren Verlangerungen der Prozedurdauer und der Durchleuchtungszeiten beobachtet worden. Die tatsachliche Rolle zerebraler Protektionssysteme in der klinischen Routine wird sich mit wachsender Evidenz wohl zukunftig erst definieren.

Objective The standard procedure of transcatheter aortic valve implantation involves transfemoral access. Nevertheless, the use of this access route is limited by the vessel diameter, calcification, and tortuosity, making a subgroup of patients ineligible for peripheral access. We report the first use of direct aortic transcatheter aortic valve implantation with the Direct Flow Medical valve (Direct Flow Medical, Inc, Santa Rosa, Calif) in 15 patients at the Halle-Wittenberg University. Methods Between January 2014 and May 2015, 55 patients with severe aortic valve disease underwent transcatheter aortic valve implantation with the Direct Flow Medical valve at the Halle-Wittenberg University. Subgroups of 15 patients were treated using direct aortic access because of small vessel diameter, excessive calcification, or extreme tortuosity of the iliofemoral vessels. Results The mean patient age was 79.1 ± 6.72 years, and 10 patients (66%) were male. The mean logistic European System for Cardiac Operative Risk Evaluation was 23.4% ± 16.9%, and the mean Society of Thoracic Surgeons score was 7.8% ± 6.8%. Access related to redo-sternotomy during transcatheter aortic valve implantation was required in 4 patients (27%). Valve retrieval was performed in 2 patients (13%). There was no conversion to surgical aortic valve replacement and no incidence of major stroke. The postimplant mean gradient was 9.3 ± 2.5 mm Hg. No patient had moderate or severe paravalvular leakage. All patients survived the first 30 days. Conclusions Direct aortic access seems to be a feasible and safe endovascular alternative for implantation of the Direct Flow Medical valve. This access provides direct and accurate control of the entire implantation procedure.

Background Outcome of Mitral Valve Prolapse (MVP) was controversial for long time. Many studies reported great differences in the incidence of cardiovascular events due, above all, to heterogeneous and small studied populations. Most of theme were also published to late '80 of the last century till early '00. Purpose To make a contemporary survey on the incidence of cardiovascular events in a selected population of patients affected by primary MVP referred to a tertiary cardiovascular center for the medical and surgical care of valvular heart disease. Methods We reviewed our MVP database; patients with at least 2 cardiologic evaluations inclusive of echocardiographic examination and at least 6 months follow up were enrolled. A total of 250 patients (126 F) were selected. Their mean age was 52.1 years (ranging from 13 to 88 yo). The average follow-up time was 100 months (8,33 yrs). Results At the first medical and echocardiographic examination 8 patients (3,2%) had no mitral regurgitation (MR), 104 (41.6%) have a trace/mild MR, 93 (37,2%) a moderate MR and 46 (18,4%) a severe MR. They were widely asymptomatic (NYHA I 205-82%, NYHA II 44-17.60%, NYHA III 1- 0.40%). Most of theme presented a bileaflet (140-55.8%) or a posterior MVP (94 - 37.6%); an isolated anterior MVP was rare (16 - 6,4%). Flail leaflet was present in 8 (3,2%) and 25 (10%) had a chordal rupture. Respectively 165 (65,6%) and 115 (46,1%) patients had thick and redundant leaflets. Mean antero-posterior mitral annulus diameter was 37 mm. During the follow up 7 patients died of non-cardiac cause and 5 (2%) of suspected cardiac cause (2 because of acute coronary syndrome and 3 died suddenly). MR progresses in 43 (17,2%) patients and finally we observed 81 (32,4%) moderate/severe and severe MR. 12 new chordal rupture occurred during the follow up in most cases concerning mitral chordae linked to posterior mitral leaflet (10 cases-83,3%). The worsening of MR provoked an evolution of the clinical condition of 48 patients (19.2%) which developed Dyspnea On Excertion (DOE) with 42 new NYHA II and 6 new NYHA III. At the end of the follow up the amount of patients symptomatic for DOE was 93 (37.2% vs 18% at the initial evaluation). A total of 45 patients (18%) underwent mitral valve surgery. 40 needed in-hospital treatment in most cases due to the development of atrial fibrillation (19 -7.6%) or heart failure ( 8- 3,2%). Endocarditis occurred in 4 patients (1.6%) and cerebrovascular accidents/cardioembolic event in 6 (2.4%). The overall cardiovascular event rate was 4,33/100 patients-year, significantly higher than reported in community based studies. Conclusions The prognosis of a MVP population referred to a tertiary cardiovascular center is not benign. The most frequent complications are progression of MR and MV surgery. Sudden death is also more frequent than in general population. More studies are needed to identify what patients with MVP are at risk for it.

Objectives: Transcatheter valve-in-valve implantation has advanced to an accepted treatment option in case of bioprosthetic failure in selected high risk patients. Herein, we present a case of direct aortic valve-in-valve implantation of a Medtronic CoreValve into a degenerated Edwards SAPIEN XT valve. Case Report: A 79-year-old woman presented with acute angina and dyspnea. Five years ago underwent transapical TAVI with a 26mm Edwards SAPIEN XT valve. Prior TAVI was complicated by wound infection, thoracic fistula, resulting in a chronic thoracic pain syndrome. Her further medical history included CABG in 1995, Re-CABG in 1996, multiple percutaneous angioplasties in 2008 and 2009, permanent atrial fibrillation, arterial hypertension as well as impaired renal function. Additionally, the left ventricular function was significantly impaired. Actually, preoperative diagnostics revealed TAVI prosthesis dysfunction, resulting in severe aortic stenosis. Due to excessive surgical risk, represented by a calculated EuroSCORE II of 11.6%, the decision was made for another catheter-based approach. Because of small sized femoral vessels and the history of complicated prior transapical access, the lady underwent direct aortic TAVI using an upper partial sternotomy. Echocardiography revealed an inner diameter of 25mm and a 26mm Medtronic CoreValve was chosen. After balloon valvuloplasty under rapid pacing, the CoreValve was slowly deployed. The procedure was uneventful and the patient was extubated in the OR. Further postoperative course was uneventful. Pre-discharge echocardiography demonstrated excellent prosthesis function without any residual aortic regurgitation. Conclusion: The direct aortic approach is a safe strategy if standard access routes are not available. By this approach, implantation of all available devices is possible. Accordingly, the described approach represents an important component of a tailor-made, risk adjusted treatment strategy.

Die chirurgische Therapie der Mitralinsuffizienz (MI) unterliegt einem bedeutsamen Wandel. Galt lange Zeit der prothetische Mitralklappenersatz als Therapie der Wahl, so wissen wir heute, dass die Mitralrekonstruktion (MKR) immer dann vorzuziehen ist, wenn die technische Moglichkeit zum Erhalt der Klappe besteht. In Deutschland trifft dies auf mehr als 80% der bedeutsamen Mitralvitien zu, was an entsprechenden Rekonstruktionsraten in erfahrenen Zentren abzulesen ist. Dabei wird die Indikation fur die Operation heute bereits beim asymptomatischen Patienten mit hochgradiger Mitralklappeninsuffizienz gestellt, vorausgesetzt die Rekonstruktionswahrscheinlichkeit ist hoch und das operative Risiko niedrig. Minimal-invasive Mitralrekonstruktionen haben nochmals zu einer deutlichen Reduktion der operativen Invasivitat gefuhrt und gehen mit niedrigen Komplikationsraten und exzellenten Ergebnissen einher. Die Mortalitat nach isolierter Mitralklappenchirurgie kann so in erfahrenen Zentren bis zu 0% betragen. Wird die Rekonstruktion zum richtigen Zeitpunkt vorgenommen, so erreicht die postoperative Lebenserwartung das Niveau einer altersentsprechenden nicht erkrankten Vergleichspopulation.

Objectives Despite progress in the treatment of cardiopulmonary organ failure, the mortality rate for patients with acute respiratory distress syndrome (ARDS) and cardiogenic shock remains high. Extracorporeal membrane oxygenation (ECMO) is a promising treatment option, but long-term outcomes and health-related quality of life (HRQOL) are unknown. Methods Detailed information related to pre- and post-device data and outcomes from a consecutive sample of 71 patients treated with ECMO was analysed. Long-term survivors were given a detailed follow-up examination after a median time of 31 months that included multiple scoring systems for HRQOL assessment. Results Seventy-one patients received a portable out-of-centre-implanted ECMO system. The survival rate at hospital discharge was 48%. Median HRQOL scores were 80% on the Karnofsky index (normal ≥80%), 80% on the Euroqol-5D (normal ≥75%) and 73.1% on the quality-of-life index (normal ≥70%). Mental scores were 96.7% on the Mini-Mental State Examination (normal ≥90.0%), 77.8% on the DemTect (normal ≥72.0%), 87.0% on the test for early detection of dementia with depression demarcation (TFDD; normal ≥74.0%) and confirmed good mental state and HRQOL for patients at follow-up. Univariate analysis for in-hospital mortality indicated that ventilation time before device implantation, higher Acute Physiology and Chronic Health Evaluation (APACHE) II score, higher lactate level at the time of ECMO implantation and female gender were associated with adverse outcomes. Conclusions In our cohort of patients, survivors of out-of-hospital ECMO implantation demonstrated good mental and quality-of-life conditions with well-recovered cardiopulmonary function during long-term follow-up. The indicators for adverse outcomes, pre-implantation lactate levels, pre-ventilation time and APACHE II score, should be considered before implantation of an ECMO device. Clinical trial This study is registered at DRKS (Deutsches Register Klinischer Studien) under the code DRKS00009735 and was submitted to the WHO.

Surgical mitral valve repair has constantly evolved to become the standard of care for severe mitral regurgitation (MR) with superior acute and long-term results compared to valve replacement. Minimally-invasive surgical techniques have been successful in reducing operative trauma while yielding equivalent or even superior results compared to the conventional sternotomy approach. However, due to elevated operative risk a growing proportion of patients are not referred for surgery, especially elderly patients with reduced ventricular function and functional MR who often present with relevant comorbidities. It is for these patients that transcatheter-based therapies may represent an attractive option. While most interventional techniques are still in experimental or early clinical stages of development, relevant clinical experience has been gained with the MitraClip® device. For successful implementation of a patient-centered mitral valve program, integration of surgical and interventional treatment modalities within a heart center is of paramount importance. This is best accomplished by an interdisciplinary dedicated heart team consisting of cardiologists and cardiac surgeons.

Marfan syndrome is a disorder of the connective tissue that is inherited in an autosomal-dominant fashion and that is caused by mutations in the gene coding for fibrillin-1, FBN1. Although complications of the syndrome may involve the eye, the lung and the skeleton, the high mortality of untreated cases results almost exclusively from cardiovascular complications, including aortic dissection, rupture and mitral valve regurgitation. The multiorgan involvement of many of these syndromes requires multidisciplinary expert centers that can increase the average life expectancy of affected patients from only 32 years to over 60 years. The present article both reviews classical standards of managing cardiovascular manifestations and highlights the surgical approach for aortic and mitral valve surgery in Marfan patients.

The incidence of valvular heart disease (VHD) has steadily increased over the past few decades in western communities and is expected to continuously do so in the face of an aging population. The majority of valvular lesions in Europe and North America are of an acquired origin and occur in the fifth to eighth decade of life. Calcified aortic valve stenosis (AS) and degenerative mitral valve regurgitation (MR) are the two most frequent forms of acquired VHD and account for over 70% of cases in Europe [1]. In Germany, about 98 000 cardiac surgical procedures are performed annually. In 2008, 33 400 cases included valve procedures with 12 300 patients receiving isolated aortic valve replacement (AVR). Mortality rates have been stable around 3 to 4% for single AVR in spite of the ever increasing average patient age and associated comorbidities. The choice of prosthesis in the aortic position has shifted with the majority of diseased valves being replaced by a bioprosthesis today [2]. In contrast to coronary surgery where the decline in the number of operations has been accompanied by a rising procedural volume of percutaneous coronary interventions (PCI) since the late 1990s, valve surgery is still expanding.