[Catheter-based and surgical treatment of mitral valve diseases]. / Katheterbasierte und operative Therapie bei Mitralklappenvitien.

There is a broad spectrum of mitral valve diseases ranging from young patients with rheumatic mitral valve stenosis up to older patients with secondary mitral valve regurgitation and numerous comorbidities. A profound understanding of the etiology, anatomical characteristics of mitral valve diseases and current treatment options is necessary to be able to prepare a patient-centered treatment approach. The interdisciplinary collaboration of referring physicians, interventional cardiologists, cardiac surgeons, heart failure and imaging specialists as well as anesthesiologists is a cornerstone of optimal patient treatment.

Longitudinal cardiac dimensions in patients undergoing LVAD implantation.

BACKGROUND: In conventional left ventricular assist devices (LVAD), a separate outflow graft is sutured to the ascending aorta. Novel device designs may include a transventricular outflow cannula crossing the aortic valve (AV). While transversal ventricular dimensions are well investigated in patients with severe heart failure, little is known about the longitudinal dimensions. These dimensions are, however, particularly critical for the design and development of mechanical circulatory support (MCS) devices with transaortic outflow cannula. METHODS: In an explorative retrospective cohort study at the University Medical Center Freiburg, Germany, the longitudinal cardiac dimensions of patients undergoing computed tomography angiography (CTA) before and, if available, after LVAD implantation were analyzed. Among others, the following dimensions were assessed: (a) apex to AV, (b) apex to mitral valve, (c) AV to sinotubular junction (STJ), (d) apex to STJ, (e) apex to brachiocephalic artery (BCA), and (f) AV to BCA. RESULTS: In total, 44 LVAD patients (36 male, age 55.8 years, height 1.75 m) were included. The longitudinal cardiac dimensions were (a) 114.5 ± 12.1 mm, (b) 108.0 ± 12.4 mm, (c) 20.9 ± 2.9, (d) 135.4 ± 13.4 mm, (e) 206.0 ± 18.3, and (f) 91.5 ± 9.8 mm. Postoperatively, (a) and (b) decreased by 31.5% and 39.5%, respectively (N = 14). CONCLUSIONS: Longitudinal cardiac dimensions may be reduced by up to 40% after LVAD implantation. A better knowledge of these dimensions and their postoperative alterations in LVAD patients may improve surgical planning and help to design MCS devices with transventricular outflow cannula.

A systematic methodology for epicardial and epiaortic echocardiography in swine research models.

Background: Perioperative echocardiography is of paramount importance during cardiac surgery. Nonetheless, in the experimental large-animal setting, it might be challenging obtaining optimal imaging when using conventional imaging acquisition techniques, such as transthoracic and transesophageal screenings. Open-chest surgery allows epicardial echocardiographic assessment with direct contact between probe and heart, thus providing superior quality. Standard protocols regarding the use of epicardial ultrasound in swine for research purposes are lacking. Methods: Epicardial echocardiography was performed in 10 female German Landrace pigs undergoing cardiac surgery. A structured and comprehensive protocol for epicardial echocardiography was elaborated including apical, ventricular long and short axis, as well as epiaortic planes. All experiments were approved by the local board for animal welfare and conducted in accordance with the German animal protection law (TierSchG) and the ARRIVE guidelines. Conclusions: Systematic protocols using epicardial echocardiography may serve as an additional tool to assess cardiac dimensions and function in experimental scenarios with swine models.

Cardiac dimensions and hemodynamics in healthy juvenile Landrace swine.

BACKGROUND: Swine are frequently used as animal model for cardiovascular research, especially in terms of representativity of human anatomy and physiology. Reference values for the most common species used in research are important for planning and execution of animal testing. Transesophageal echocardiography is the gold standard for intraoperative imaging, but can be technically challenging in swine. Its predecessor, epicardial echocardiography (EE), is a simple and fast intraoperative imaging technique, which allows comprehensive and goal-directed assessment. However, there are few echocardiographic studies describing echocardiographic parameters in juvenile swine, none of them using EE. Therefore, in this study, we provide a comprehensive dataset on multiple geometric and functional echocardiographic parameters, as well as basic hemodynamic parameters in swine using EE. METHODS: The data collection was performed during animal testing in ten female swine (German Landrace, 104.4 ± 13.0 kg) before left ventricular assist device implantation. Hemodynamic data was recorded continuously, before and during EE. The herein described echocardiographic measurements were acquired according to a standardized protocol, encompassing apical, left ventricular short axis and long axis as well as epiaortic windows. In total, 50 echocardiographic parameters and 10 hemodynamic parameters were assessed. RESULTS: Epicardial echocardiography was successfully performed in all animals, with a median screening time of 14 min (interquartile range 11-18 min). Referring to left ventricular function, ejection fraction was 51.6 ± 5.9% and 51.2 ± 6.2% using the Teichholz and Simpson methods, respectively. Calculated ventricular mass was 301.1 ± 64.0 g, as the left ventricular end-systolic and end-diastolic diameters were 35.3 ± 2.5 mm and 48.2 ± 3.5 mm, respectively. The mean heart rate was 103 ± 28 bpm, mean arterial pressure was 101 ± 20 mmHg and mean flow at the common carotid artery was 627 ± 203 mL/min. CONCLUSION: Epicardial echocardiography allows comprehensive assessment of most common echocardiographic parameters. Compared to humans, there are important differences in swine with respect to ventricular mass, size and wall thickness, especially in the right heart. Most hemodynamic parameters were comparable between swine and humans. This data supports study planning, animal and device selection, reinforcing the three R principles in animal research.

Cardioaortic dimensions in German landrace pigs derived from cardiac magnetic resonance imaging.

Pigs are frequently applied as animal models in cardiovascular research due to their anatomical and physiological similarity to humans. For study planning and refinement, precise knowledge of the cardioaortic dimensions is essential. In a retrospective single-center study, the cardioaortic dimensions and left ventricular function of German Landrace pigs were assessed using cardiac MRI. All parameters were compared between male and female pigs and analyzed for correlation with body weight. In total, 15 pigs were included (7 male and 8 female, weight 60.9 ± 7.0 kg). The left ventricle revealed an end-diastolic diameter of 50.5 ± 4.4 mm and an ejection fraction of 51.2 ± 9.8%. The diameters of the ascending and descending aorta were 21.3 ± 2.3 and 16.2 ± 1.4 mm, respectively. There were no significant differences between male and female pigs, except that males had a smaller end-diastolic left ventricular volume (p = 0.041). A moderate correlation was found between body weight and the aortic annulus diameter (R = 0.57, p = 0.027). In conclusion, cardiac MRI allows precise quantification of porcine cardioaortic dimensions. For medical device testing, size differences between pigs and humans should be considered.

Intra-aortic band impairs transapical device implantation in a pig: a case report.

BACKGROUND: Anatomic anomalies in the ascending aorta may impair the implantation and testing of cardiovascular devices in humans and animal models. CASE PRESENTATION: We present the rare case of an intra-aortic band in a German Landrace pig. During terminal animal testing, the band hindered the implantation of a left ventricular assist device (LVAD) with transventricular outflow graft across the aortic valve. After lower partial sternotomy, epicardial echocardiography displayed an intraluminal echogenic structure at the sinotubular junction causing unspecific flow turbulences. Under cardiopulmonary bypass, coring of the left ventricular apex was performed. Due to strong resistance in the proximal aorta, accurate positioning of the transventricular LVAD outflow graft was impossible. After euthanasia, necropsy revealed a fibrous band located at the sinotubular junction, dividing the lumen of the ascending aorta. CONCLUSIONS: The occurrence of an intra-aortic band represents an extremely rare case of a most likely congenital anomaly. Awareness of such anomalies is important for planning and performing animal testing. Perioperative echocardiography may help to either remove such anomalies or allow discontinuing the procedure prior to device implantation.

Impact of an Accessory for Left Ventricular Assist Devices on Device Flow and Pressure Head In Vitro.

A novel accessory directing the blood from the outflow of a left ventricular assist device (LVAD) back through the left ventricular apex and across the aortic valve allows LVAD implantation via the left ventricular apex solely but may affect the LVAD performance. We quantified the effect of the accessory on LVAD flow and pressure head in vitro. In a mock circulatory loop, a centrifugal-flow LVAD (HeartMate 3, Abbott, Abbott Park, IL, USA) with (Accessory) and without the accessory (Control) was compared under physiological conditions using a water/glycerol solution as a blood substitute. The pump was operated at 4000, 5200, and 6400 rpm and 5 different resistance levels. Flow, inlet, and outlet pressure were measured, and pressure head was calculated. Compared to the Control, flow and pressure head in the Accessory group were reduced by an overall average of 0.26 L/min and 9.9 mmHg (all speeds and resistance levels). The highest decline in flow and pressure head occurred at the lowest resistance levels. In conclusion, the accessory leads to a reduction of LVAD flow and pressure head that is enhanced by decreases in resistance. Future developments in the LVAD accessory's design may reduce these effects and allow unimpaired LVAD performance and minimally invasive device implantation.

Impact of Procedure Volume on the Outcomes of Surgical Aortic Valve Replacement.

BACKGROUND: Literature demonstrated that procedure volumes affect outcomes of patients undergoing transcatheter aortic valve implantation. We evaluated the outcomes of surgical aortic valve replacement. METHODS: All isolated surgical aortic valve replacement procedures in Germany in 2017 were identified. Hospitals were divided into five groups from ≤25 (very low volume) until >100 (very high volume) annual procedures. RESULTS: In 2017, 5,533 patients underwent isolated surgical aortic valve replacement. All groups were of comparable risk (logistic EuroSCORE, 5.12-4.80%) and age (66.6-68.1 years). In-hospital mortality and complication rates were lowest in the very high-volume group. Multivariable logistic regression analyses showed no significant volume-outcome relationship for in-hospital mortality, stroke, postoperative delirium, and mechanical ventilation > 48 hours. Regarding acute kidney injury, patients in the very high-volume group were at lower risk than those in the very low volume group (odds ratio [OR] = 0.53, p = 0.04). Risk factors for in-hospital mortality were previous cardiac surgery (OR = 5.75, p < 0.001), high-grade renal disease (glomerular filtration rate < 15 mL/min, OR = 5.61, p = 0.002), surgery in emergency cases (OR = 2.71, p = 0.002), and higher grade heart failure (NYHA [New York Heart Association] III/IV; OR = 1.80, p = 0.02). Risk factors for all four complication rates were atrial fibrillation and diabetes mellitus. CONCLUSION: Patients treated in very low volume centers (≤25 operations/year) had a similar risk regarding in-hospital mortality and most complications compared with very high-volume centers (>100 operations/year). Only in the case of acute kidney injury, very high-volume centers showed better outcomes than very low volume centers. Therefore, surgical aortic valve replacement can be performed safely independent of case volume.

Development of a Novel Adapter to Enable Less-Invasive Left Ventricular Assist Device Implantation via the Left Ventricular Apex.

The first prototype of an adapter to enable left ventricular assist device (LVAD) implantation solely via the left ventricular (LV) apex and without requiring cardiopulmonary bypass (CPB) was tested in healthy and acutely failing pig hearts. The adapter consists of a fixation, blood guiding, and connecting module fitting to a HeartMate 3 (HM3; Abbott, Chicago, IL) pump. Implantation was performed via a left thoracotomy in five pigs (96 ± 18 kg). Invasive blood pressure was measured before (CTRL), 30 minutes after HM3 initiation (HM3_CTRL), during acute heart failure (HF) induced by rapid pacing (CTRL_HF), and 5 minutes after initiating HM3 support (HM3_HF). To further estimate the LVAD performance, blood pressure amplitudes were calculated in the healthy heart without (CTRL) and with HM3 support (HM3_CTRL) as: systolic-diastolic blood pressure. Our adapter implantation and connection to the HM3 pump succeeded in all animals. Compared to the normal beating healthy heart, blood pressure amplitudes were significantly smaller during HM3 support (CTRL: 41 ± 5 mm Hg vs. HM3_CTRL: 20 ± 4 mm Hg; p < 0.05). Under HF conditions, mean blood pressure returned to normal values after pump initiation (CTRL_HF: 29 ± 6 mm Hg, HM3_HF: 83 ± 24 mm Hg). The adapter prototype allowed safe, straightforward, and less-invasive LVAD implantation solely via the LV apex without using CPB and support of the LV during acute HF in the pig heart.

Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial.

BACKGROUND: Cardiac surgery often represents the only treatment option in patients with infective endocarditis (IE). However, IE surgery may lead to a sudden release of inflammatory mediators, which is associated with postoperative organ dysfunction. We investigated the effect of hemoadsorption during IE surgery on postoperative organ dysfunction. METHODS: This multicenter, randomized, nonblinded, controlled trial assigned patients undergoing cardiac surgery for IE to hemoadsorption (integration of CytoSorb to cardiopulmonary bypass) or control. The primary outcome (change in sequential organ failure assessment score [ΔSOFA]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score. The analysis was by modified intention to treat. A predefined intergroup comparison was performed using a linear mixed model for ΔSOFA including surgeon and baseline SOFA score as fixed effect covariates and with the surgical center as random effect. The SOFA score assesses dysfunction in 6 organ systems, each scored from 0 to 4. Higher scores indicate worsening dysfunction. Secondary outcomes were 30-day mortality, duration of mechanical ventilation, and vasopressor and renal replacement therapy. Cytokines were measured in the first 50 patients. RESULTS: Between January 17, 2018, and January 31, 2020, a total of 288 patients were randomly assigned to hemoadsorption (n=142) or control (n=146). Four patients in the hemoadsorption and 2 in the control group were excluded because they did not undergo surgery. The primary outcome, ΔSOFA, did not differ between the hemoadsorption and the control group (1.79±3.75 and 1.93±3.53, respectively; 95% CI, -1.30 to 0.83; P=0.6766). Mortality at 30 days (21% hemoadsorption versus 22% control; P=0.782), duration of mechanical ventilation, and vasopressor and renal replacement therapy did not differ between groups. Levels of interleukin-1ß and interleukin-18 at the end of integration of hemoadsorption to cardiopulmonary bypass were significantly lower in the hemoadsorption than in the control group. CONCLUSIONS: This randomized trial failed to demonstrate a reduction in postoperative organ dysfunction through intraoperative hemoadsorption in patients undergoing cardiac surgery for IE. Although hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, there was no difference in any of the clinically relevant outcome measures. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03266302.

Hemocompatible Surfaces Through Surface-attached Hydrogel Coatings and their Functional Stability in a Medical Environment.

Blood compatible materials are a well-researched scientific field as such materials are required in a wide range of applications, for example, in heart-lung machines or ventricular assist devices. Surfaces coated with certain surface-bound neutral, water-swellable polymer networks have the ability to repel cells such as platelets and exhibit a significantly improved hemocompatibility. In this study, we investigate the interaction of platelets from whole blood with surfaces coated with photochemically generated surface-attached polymer networks based on polydimethyl acrylamide. As substrates medical-grade polyurethanes are used, and the networks are formed and attached to the substrate surfaces through C-H insertion reactions. The hydrogel-coated substrates are perfused with blood for extended periods of time. We show that the polymer coating prevents the adhesion of cells even at longer times of blood contact, regardless of the thickness of the coating employed. The surfaces can be sterilized following a standard autoclave procedure without any loss of function. Additionally, it is shown that the samples can be stored at least for 3 months under varying ambient conditions while retaining their functionality. The excellent blood compatibility, the possibility to coat even rather inert polymeric materials and the ability to handle the materials in an environment typical for a medical application make such coatings a promising candidate for future hemocompatible devices.

In-hospital outcomes of patients undergoing concomitant aortic and mitral valve replacement in Germany.

OBJECTIVES: To evaluate in-hospital outcomes of concomitant mitral valve replacement (MVR) in patients undergoing conventional aortic valve replacement due to aortic stenosis in a nationwide cohort. METHODS: Administrative data from all patients with aortic stenosis undergoing conventional aortic and concomitant MVR (reason for MVR not specified) between 2017 and 2018 in Germany were analysed. RESULTS: A total of 2597 patients with a preoperative logistic EuroScore of 9.81 (standard deviation: 8.56) were identified. In-hospital mortality was 6.8%. An in-hospital stroke occurred in 3.4%, acute kidney injury in 16.3%, prolonged mechanical ventilation of more than 48 h in 16.3%, postoperative delirium in 15.8% and postoperative pacemaker implantation in 7.6% of the patients. Mean hospital stay was 16.5 (standard deviation: 12.1) days. Age [odds ratio (OR): 1.03; P = 0.019], New York Heart Association class III or IV (OR: 1.63; P = 0.012), previous cardiac surgery (OR: 2.85, P = 0.002), peripheral vascular disease (OR: 2.01, P = 0.031), pulmonary hypertension (OR: 1.63, P = 0.042) and impaired renal function (glomerular filtration rate <15, OR: 3.58, P = 0.001; glomerular filtration rate <30, OR: 2.51, P = 0.037) were identified as independent predictors for in-hospital mortality. CONCLUSIONS: In this nationwide analysis, concomitant aortic and MVR was associated with acceptable in-hospital mortality, morbidity and length of in-hospital stay. The regression analyses may help to identify high-risk patients and further optimize treatment strategies.

Transapical aortic valve replacement versus surgical aortic valve replacement: A subgroup analyses for at-risk populations.

BACKGROUND: If the transfemoral access is not feasible, a transapical access or surgical aortic valve replacement (SAVR) are alternatives for patients with aortic valve stenosis. OBJECTIVES: To identify patient groups who benefit from SAVR or transapical transcatheter aortic valve replacement (TA-TAVR), we compared in-hospital outcomes of patients in a nationwide dataset. METHODS: We identified 19,016 isolated SAVR and 6432 TA-TAVR performed in Germany from 2014 to 2016. We adjusted for risk factors using a covariate- and propensity-adjusted analysis. RESULTS: Patients undergoing TA-TAVR were older, had more comorbidities, and accordingly greater estimated operative risk (logistic European System for Cardiac Operative Risk Evaluation 5.3 vs 17.0, P < .001). However, adjusted risk for in-hospital complications such as stroke, acute kidney injury, relevant bleeding, and prolonged mechanical ventilation >48 hours was lower in patients undergoing TA-TAVR (all P < .001). When we compared in-hospital mortality of all patients undergoing either TA-TAVR or SAVR, neither treatment strategy had a clear advantage (covariate-adjusted odds ratio [caOR], 1.13, P = .251; propensity-adjusted OR [paOR], 1.12, P = .309). Two patient subgroups seem to benefit more from SAVR than TA-TAVR: patients <75 years (caOR, 1.29, P = .237; paOR, 2.12, P = .001) and those with European System for Cardiac Operative Risk Evaluation 4-9 (caOR, 1.32, P = .114; paOR, 1.43, P = .041). Female patients had a tendency toward lower risk for in-hospital mortality when undergoing SAVR (caOR, 1.42, P = .030). In patients with chronic renal failure, TA-TAVR was superior (caOR, 0.56, P = .039, P = .040). CONCLUSIONS: Patients <75 years and those at low operative risk who underwent SAVR had lower in-hospital mortality than those undergoing TA-TAVR. Patients with chronic renal failure who underwent TA-TAVR had lower in hospital mortality than those that underwent SAVR.

Use and Outcomes of Acute Treatment Strategies in Patients with Severe Aortic Valve Stenosis.

Background: This study aimed to evaluate the acute treatment of patients with severe aortic valve stenosis in Germany. Methods and Results: Three treatment strategies in 11,027 patients acutely admitted due to aortic valve stenosis were compared from 2014 until 2018 using German nationwide records: The annual number of transcatheter aortic valve replacement (TAVR) procedures (1,294 to 1,827) and balloon valvuloplasty (BV only) procedures (170 to 233) in patients acutely admitted increased, but surgical aortic valve replacement (SAVR) procedures decreased (426 to 316). In comparison to BV only patients (mean age 81.3; EuroSCORE 23.2) SAVR patients were younger and at lower logistic EuroSCORE (mean age 66.9; EuroSCORE 9.4). Patients treated with TAVR were at comparable age and operative risk (mean age 81.3; EuroSCORE 24.4) as those patients treated with BV only. Primary outcome was in-hospital mortality. Reimbursement was considered secondary outcome. After risk adjustment using multivariable logistic and linear regression analyses, SAVR (OR 0.26 [96%CI 0.16;0.45], p < 0.001) and TAVR (OR 0.38 [0.29;0.49], p < 0.001) were associated with lower risk for mortality compared to BV only. Compared to BV only, hospitalization costs of patients undergoing SAVR were reduced by €5,578 ([95%CI €8,023; €3,133], p < 0.001). TAVR procedures were associated with higher hospitalization costs than BV only (risk-adjusted difference €4,143 [€2,330; €5,926], p < 0.001). Conclusions: BV only was associated with a substantially increased risk of in-hospital mortality in acute patients. We conclude that a definitive aortic valve replacement should be preferred as primary treatment in patients with severe aortic valve stenosis causing an acute admission.

Impact of Preprocedural Aortic Valve Calcification on Conduction Disturbances after Transfemoral Aortic Valve Replacement.

AIM: The present study analyzes in depth the impact of different calcification patterns on disturbances of the conduction system in transcatheter aortic valve replacement (TAVR) patients. METHODS AND RESULTS: A total of 169 preprocedural TAVR multislice computed tomography scans from consecutive transfemoral (TF) TAVRs performed between 2014 and 2017 using either Edwards SAPIEN or Medtronic Evolut R valves were retrospectively evaluated. The volume, distribution, and orientation of annular and valvular aortic valve calcification were measured and their impact on postoperative conduction disturbances was determined using linear and logistic regression analyses. The total volume of calcification and distribution at the aortic annulus or valve did not influence the conduction system. Oval calcification of the left aortic cusp was independently associated with an elevated risk for an increase in atrioventricular block degree (+0.6, p = 0.03). Moreover, orthogonal calcifications at the level of the aortic annulus were associated with an increased risk for QRS prolongation (+26 ms, p = 0.004) and an increased risk for permanent pacemaker implantation (OR 4.3, p = 0.03) after TF TAVR. This was more pronounced in patients undergoing TF TAVR using a balloon-expandable Edwards SAPIEN 3 valve (QRS +38.195 ms, p < 0.001; OR permanent pacemaker 15.48, p = 0.013). CONCLUSION: Orthogonal annular calcification confers an increased risk for conduction disturbances after TAVR. This is even more pronounced after implantation of balloon-expandable valves.

Bleeding Complications Drive In-Hospital Mortality of Patients with Atrial Fibrillation after Transcatheter Aortic Valve Replacement.

BACKGROUND: Atrial fibrillation (AF) is a risk factor for poor postoperative outcome after transfemoral transcatheter aortic valve replacement (TF-TAVR). The present study analyses the outcomes after TF-TAVR in patients with or without AF and identifies independent predictors for in-hospital mortality in clinical practice. METHODS AND RESULTS: Among all 57,050 patients undergoing isolated TF-TAVR between 2008 and 2016 in Germany, 44.2% of patients (n = 25,309) had AF. Patients with AF were at higher risk for unfavorable in-hospital outcome after TAVR. Including all baseline characteristics for a risk-adjusted comparison, AF was an independent risk factor for in-hospital mortality after TAVR. Among patients with AF, EuroSCORE, New York Heart Association classification class, or renal disease had only moderate effects on mortality, while the occurrence of postprocedural stroke or moderate to major bleeding substantially increased in-hospital mortality (odds ratio [OR] 3.35, 95% confidence interval [CI] 2.61-4.30, p < 0.001 and OR 3.12, 95% CI 2.68-3.62, p < 0.001). However, the strongest independent predictor for in-hospital mortality among patients with AF was severe bleeding (OR 18.00, 95% CI 15.22-21.30, p < 0.001). CONCLUSION: The present study demonstrates that the incidence of bleeding defines the in-hospital outcome of patients with AF after TF-TAVR. Thus, the periprocedural phase demands particular care in bleeding prevention.

A logistic regression analysis comparing minimalistic approach and intubation anaesthesia in patients undergoing transfemoral transcatheter aortic valve replacement.

AIMS: Patients with postoperative delirium (POD) after transcatheter aortic valve replacement (TAVR) are ventilated and hospitalized longer and suffer increased in-hospital mortality. This study hypothesized that a minimalistic approach with conscious sedation during transfemoral aortic valve replacement (TF-AVR) protects against delirium, time of mechanical ventilation, and increased length of stay in intensive care unit (ICU) compared to intubation anaesthesia. METHODS AND RESULTS: 308 patients which underwent TF-AVR in our centre between 01/2013 and 08/2017 were retrospectively evaluated regarding postoperative delirium, time of mechanical ventilation, and days in ICU. TF-AVR was performed with intubation anaesthesia in 245 patients and with conscious sedation in 63. The operative risk estimated by the logEUROScore was similar in both groups (intubation: 13.28 +/-9.06%, conscious sedation: 12.24 +/-6.77%, p = 0.395). In the conscious sedation group procedure duration was shorter (0.61 +/-0.91h vs. 1.75 +/-0.96h, p<0.001). The risk for intraprocedural complications was not influenced by the anaesthesia method (OR conscious sedation instead of intubation 1.66, p = 0.117), but days on ICU (-2.21 days, p<0.0001) and minutes of mechanical ventilation (-531.2 min, p < 0.0001) were reduced. Furthermore, the risk of POD was decreased when TF-AVR was performed under conscious sedation (6.35% vs. 18.18%, OR 0.29, p = 0.021). CONCLUSIONS: Time of mechanical ventilation, risk of POD, and days on ICU were substantially reduced in patients who underwent TF-AVR under conscious sedation. Our data suggest that TF-AVR with conscious sedation is safe with a beneficial postoperative course in clinical practice, and should be considered the favoured approach.

Nationwide outcomes of aortic valve replacement for pure aortic regurgitation in Germany 2008-2015.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is routinely used in patients with severe aortic stenosis at increased operative risk. Due to potential technical difficulties, TAVR is not recommended for pure aortic regurgitation (AR). Smaller studies reported its use in AR, but data from big registries are lacking. The present study analyzes the nationwide use of surgical aortic valve replacement (SAVR) and TAVR in patients with AR from 2008 until 2015. METHODS: We identified 138,237 cases of aortic valve replacement in Germany based on ICD and OPS codes. RESULTS: Of 13.2% SAVR-cases and 1.3% of TAVR cases were performed in AR. AR patients undergoing SAVR were younger with lower logistic EuroSCORE (stenosis: 6.1 ± 5.6; AR: 4.5 ± 4.9). Nevertheless, stroke rates, bleedings, prolonged mechanical ventilation, and in-hospital mortality were higher (mortality: stenosis 2.6%, AR: 4.7%). In the TAVR group, patients with AR were at higher operative risk (logistic EuroSCORE: transfemoral (TF)-TAVR: stenosis: 14.3 ± 10.4; AR: 17.3 ± 13.3. Transapical (TA)-TAVR: stenosis: 16.1 ± 11.4; AR: 15.7 ± 12.2). Stroke rates were lower, but bleedings and prolonged ventilation occurred more frequently after TF-TAVR in AR compared to stenosis. The mortality varied markedly (TF-TAVR: 15.2% in 2011; 2.8% in 2015; TA-TAVR: 17.7% in 2012 and 0% in 2014). CONCLUSION: TAVR is off-label used in AR in clinical practice. TAVR seems to be a safe option for AR with regard to in-hospital outcomes. However, further research evaluating long-term outcomes is required to establish the feasibility of TAVR in pure AR.

Predictors of survival in patients with acute coronary syndrome undergoing percutaneous coronary intervention of unprotected left main coronary artery stenosis.

OBJECTIVE: Aim of this study was to investigate predictors of survival in unstable patients with high SYNTAX-1-score. BACKGROUND: In significant unprotected left main coronary artery (ULMCA) stenosis, treatment options include percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). While CABG is recommended for stable patients with ULMCA stenosis and a SYNTAX-1-score > 32, PCI may be preferable in unstable or high operative risk patients. METHODS: Retrospective single-center all-comers registry study. RESULTS: A total of 142 patients underwent ULMCA-PCI (~72.9 years, 23.2% females, 54.2% survival in 2-year follow-up), 84 of whom had a SYNTAX-1 > 32 (37.4 ± 12.8). Patients in the high-SYNTAX-1-group (score > 32) were more often in an acute condition compared to low-SYNTAX-2-group (score ≤ 32) including acute myocardial infarction (76.2% vs. 57.4%, p = .024), cardiogenic shock (48.2% vs. 14.8%, p = .001), or need for mechanical support (36.1% vs. 11.1%, p = .001). Survival was predicted by the acute condition including cardiogenic shock (OR 0.06 and 0.05) and myocardial infarction (OR 0.03 and 0.34) in both groups. Performance of the SYNTAX-1-score was limited in our patient collective in both groups (c-index 0.65 vs. 0.63) while SYNTAX-2-PCI-score performed better (c-index 0.67 vs. 0.67). EuroScore II had the best discriminative ability (c-index 0.87 vs. 0.78). CONCLUSIONS: The majority of patients undergoing ULMCA-PCI presented in acute conditions with high SYNTAX-1-score, and is therefore underrepresented in clinical trials. Prognosis was best predicted by the acute condition and the EuroScore II. These data suggest that therapy in unstable patients should be guided by clinical condition over the anatomical SYNTAX-1-score.