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.

Extracorporeal Membrane Oxygenation for Graft Dysfunction Early After Heart Transplantation: A Systematic Review and Meta-analysis.

INTRODUCTION: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a prevailing option for the management of severe early graft dysfunction. This systematic review and individual patient data (IPD) meta-analysis aims to evaluate (1) mortality, (2) rates of major complications, (3) prognostic factors, and (4) the effect of different VA-ECMO strategies on outcomes in adult heart transplant (HT) recipients supported with VA-ECMO. METHODS AND RESULTS: We conducted a systematic search and included studies of adults (≥18 years) who received VA-ECMO during their index hospitalization after HT and reported on mortality at any timepoint. We pooled data using random effects models. To identify prognostic factors, we analysed IPD using mixed effects logistic regression. We assessed the certainty in the evidence using the GRADE framework. We included 49 observational studies of 1477 patients who received VA-ECMO after HT, of which 15 studies provided IPD for 448 patients. There were no differences in mortality estimates between IPD and non-IPD studies. The short-term (30-day/in-hospital) mortality estimate was 33% (moderate certainty, 95% confidence interval [CI] 28%-39%) and 1-year mortality estimate 50% (moderate certainty, 95% CI 43%-57%). Recipient age (odds ratio 1.02, 95% CI 1.01-1.04) and prior sternotomy (OR 1.57, 95% CI 0.99-2.49) are associated with increased short-term mortality. There is low certainty evidence that early intraoperative cannulation and peripheral cannulation reduce the risk of short-term death. CONCLUSIONS: One-third of patients who receive VA-ECMO for early graft dysfunction do not survive 30 days or to hospital discharge, and one-half do not survive to 1 year after HT. Improving outcomes will require ongoing research focused on optimizing VA-ECMO strategies and care in the first year after HT.

Molecular Mechanisms of Diaphragm Myopathy in Humans With Severe Heart Failure.

[Figure: see text].

[Physician Assistants - Eine effektive und sinnvolle Erweiterung des herzchirurgischen Behandlungsteams]. / Positionspapier der Deutschen Gesellschaft für Thorax-, Herz- und Gefäßchirurgie zum Einsatz von Physician Assistants in der Herzchirurgie.

High-quality care of cardiac surgical patients requires the employment and recruiting of qualified medical professionals with minimal fluctuation of staff members. This aspect becomes increasingly difficult due to the current shortage of skilled professionals as well as the present framework conditions of the German Healthcare System. The implementation of physician assistants (PA) in cardiac surgery departments may augment existing human resource concepts in an innovative and sustainable manner, tailored to meet department specific requirements. Long-term experiences from Anglo-American countries prove that the implementation of a PA system may stabilize or potentially even improve medical treatment quality. At the same time, cardiac surgical residents may be relieved from routine tasks, releasing additional time resources for a solid and diverse specialist training. Furthermore, positive effects on economic aspects of an institution may be possible. The required delegation of medical tasks to allied health professionals already has a legal basis in Germany, while a specific legal framework tailored to physician assistants does not exist yet. In this context, it is an important aspect that medical associations define a reliable catalog of tasks that may be delegated to physician assistants. Under evaluation of medical, legal and economic aspects and in a structured manner, this position paper defines medical tasks of physician assistants in cardiac surgery.

Comparison of periodontal parameters between patients with ischemic and dilative cardiomyopathy.

BACKGROUND: This cross-sectional study aimed in the comparison of periodontal parameters, number of remaining teeth and oral behaviour between patients with ischemic- (ICM) and non-ischemic dilative cardiomyopathy (DCM). METHODS: Patients with HF from the Department for Cardiac Surgery at the Heart Center Leipzig were included. The two groups (ICM and DCM) were composed by matching according to age, gender and smoking habits. All participants received a comprehensive periodontal examination, including a periodontal probing on six measurement points of each tooth. RESULTS: A total of 226 patients (n = 113 each group) was included. Patients in DCM group used interdental cleaning significantly more often than ICM (23.9% vs. 12.5%, p = 0.04). The majority of patients in both groups (ICM: 83.6%, DCM: 84.6%, p = 0.23) were diagnosed with stage III-IV periodontitis. Periodontal parameters were comparable between groups (p > 0.05). Variance analysis revealed no influence of the group (ICM vs. DCM) on the number of remaining teeth (p = 0.16), periodontitis stage (p = 0.27) or the periodontal inflamed surface area (p = 0.62). CONCLUSIONS: Patients with severe HF show high periodontal burden, without any differences between ICM and DCM group. Therefore, increased attention should be payed to periodontal health of patients with severe heart disease, irrespective of their underlying disease.

Benefit of Self-Managed Anticoagulation in Patients with Left Ventricular Assist Device.

BACKGROUND: The exact monitoring of the therapeutic-range international normalized ratio (INR) after left ventricular assist device (LVAD) implantation is an important aim to reduce the risk of thrombosis or bleeding complications. Service providers offer a telemedical anticoagulation service (CS). METHODS: We compared LVAD patients using the CS (n = 15) to those who received regular medical care (RMC; n = 15) to investigate if telemedicine supervision increased the INR-specific time in the therapeutic range (TTR) during anticoagulation. All patients received self-management training for phenprocoumon medication according to their INR value. INR values were documented for 12 months. A survey (scale: 1 = not satisfied and 10 = very satisfied) was used to determine patient's satisfaction and psychological well-being. RESULTS: A total of 1,798 INR measurements were analyzed. The TTRRosendaal was higher in patients undergoing RMC (78.1 ± 14.3%) compared with that in patients using the CS (58.3 ± 28.0%, p = 0.03). The patient's satisfaction with the coagulation setting at the beginning of the study (RMC: 6.7 ± 3.1, CS: 7.2 ± 3.0, p = 0.74) and psychological wellbeing (RMC: 6.5 ± 1.9, CS: 6.5 ± 2.7, p = 0.97) were comparable between both groups. CONCLUSION: We found that INR self-management is superior regarding the efficiency of post-LVAD anticoagulation therapy when compared with telemedical (CS)-based INR management in a small study cohort. Intensive training by experienced staff was able to replace CS.

Predictors of Mortality in Primary Surgical Repair of Postinfarction Ventricular Septal Defects: The Leipzig Experience.

BACKGROUND: A postinfarction ventricular septal defect (pVSD) as a complication of acute myocardial infarction (AMI) is associated with high mortality. This retrospective, single-center study aimed to identify predictors of early and long-term outcomes in patients undergoing primary surgical repair of pVSD managed by various surgical techniques. METHODS: We reviewed data from 77 consecutive patients who underwent primary surgical repair after pVSD in our institution. Prospectively collected demographic and perioperative data were analyzed retrospectively. Predictors of 30-day mortality and long-term outcome were assessed. RESULTS: pVSD was anterior in 45 patients (58.4%) and posterior in 32 (41.6%). Buttressed mattress suture (n = 9, 11.7%), simple single septal patch (n = 34, 44.2%), simple double septal patch (n = 2, 2.6%), sandwich double patch (n = 1, 1.3%), and the infarct exclusion technique (n = 31, 40.3%) were performed for surgical closure. Fifty-three patients (68.8%) had preoperative cardiogenic shock. The 30-day mortality was 42.8% (33 patients). Independent risk factors of 30-day mortality were duration between AMI and surgery <7 days (odds ratio [OR] 5.229, P = .011), preoperative absence of diuretics (OR 6.913, P = .005), and preoperative cardiogenic shock (OR 3.558, P = .011). Cumulative survival rates at 1, 5, and 10 years were 57.1%, 57.1%, and 31.2%, respectively. CONCLUSION: In pVSD, the 30-day mortality remains high, and preoperative cardiogenic shock significantly influenced mortality in our study. None of the surgical techniques or materials used in our investigation influenced the outcome.

Oral health-related quality of life in patients with heart failure and left ventricular assist devices-results of a cross-sectional study.

OBJECTIVES: The aim of this cross-sectional study was to compare oral health-related quality of life (OHRQoL) of patients with left ventricular assist device (LVAD) and heart failure (HF). MATERIAL AND METHODS: Seventy-four patients with LVAD were recruited from University Department for Cardiac Surgery, Leipzig Heart Center, Germany. A group of 72 patients with HF was composed by matching (age, gender, smoking). The German short form of oral health impact profile (OHIP G14) was applied. Health-related quality of life (HRQoL) was measured by short form 36 survey (SF-36). Dental conditions (decayed-, missing- and filled-teeth [DMF-T]), remaining teeth and periodontal findings were assessed. STATISTICS: t-test, Mann-Whitney U test, Kruskal-Wallis test, chi-square or Fisher test, linear regression. RESULTS: Age, gender, smoking, underlying disease, co-morbidities and oral findings were comparable between groups (p > 0.05). OHIP G14 sum score was 3.53 ± 6.82 (LVAD) and 2.92 ± 5.35 (HF; p = 0.70), respectively. The scales SF-36 physical functioning (p = 0.05) and SF-36 social functioning (p < 0.01) were worse in LVAD. In the LVAD group, the DMF-T and remaining teeth negatively correlated with OHIP G14 sum score (p < 0.01). In HF patients, positive correlations were found between OHIP G14 and D-T (p < 0.01) and remaining teeth (p = 0.04). Moreover, DMF-T (p = 0.03) and remaining molars/premolars (p = 0.02) were negatively correlated with SF-36 scales in HF. CONCLUSIONS: Oral health and OHRQoL was comparable between LVAD and HF; thereby, OHRQoL reflected the clinical oral status. CLINICAL RELEVANCE: Dental care, with beginning in early stage of HF, should be fostered to preserve teeth and support quality of life before and after LVAD implantation.

Midterm results after St Jude Medical Epic porcine xenograft for aortic, mitral, and double valve replacement.

BACKGROUND: The aim of this study was to evaluate the results after stented porcine xenograft implantation (Epic, SJM, St Paul, MN) with Linx anticalcification treatment in elderly patients at our high-volume tertiary care center. METHODS: A total of 3825 patients undergoing aortic (AVR = 2441), mitral (MVR = 892), or double valve (DVR = 492) replacement between 11/2001 and 12/2017 with Epic xenografts were evaluated. Outcomes were assessed by reviewing the prospectively acquired hospital database results, and regular annual follow-up information was acquired from questionnaires or telephone interviews. RESULTS: For patients undergoing AVR, MVR, DVR, age at surgery were 76.4 ± 6, 71.2 ± 9, 72.9 ± 8 years; active endocarditis was an indication for valve surgery in 4.5%, 20.7%, 19.7%; and the predicted median (interquartile range [IQR]) mortality risk (EuroSCORE II) was 5.2% (3.1%-9.4%), 7.5% (3.9%-16.2%), 9.9% (6.0%-19.6%), respectively. Median follow-up was 3.04 (IQR: 0.18-5.21). Thirty-day survival was 91.2% ± 0.6%, 87.6% ± 0.1.1%, 84.7% ± 1.6%; and 10-year survival was 56.7% ± 1.0%, 59.4% ± 2.5%, 50.45% ± 3.1%, respectively. Patients who underwent MVR versus AVR were at significant increased risk for reoperation for endocarditis (adjusted odds ratio; 2.2, 95% confidence interval; 1.29-3.7; P = .003). There was no significant difference in all-cause mortality at midterm in AVR vs MVR in the matched cohort (P = .85). CONCLUSIONS: Implantation of the Epic stented porcine xenograft is associated with acceptable survival and freedom from valve-related complications or reoperation due to structural valve disease at midterm follow-up.

Ischemic Cardiomyopathy Affects the Thioredoxin System in the Human Myocardium.

BACKGROUND: Oxidative stress due to reactive oxygen species (ROS) production is a key factor in the development of heart failure (HF). This study investigated the thioredoxin (Trx) system, which plays a major role in antioxidant defense, in patients suffering from ischemic (ICM) or dilated (DCM) cardiomyopathy. METHODS AND RESULTS: Myocardial tissue from ICM (n = 13) and DCM (n = 13) patients, as well as septal tissue of patients with aortic stenosis but without diagnosed hypertrophic cardiomyopathy or subaortic stenosis (control; n = 12), was analyzed for Trx1, Trx-interacting protein (TXNIP) and E3 ligase ITCH (E3 ubiquitin-protein ligase Itchy homolog) expression. Trx-reductase 1 (TXNRD1) amount and activity, cytosolic cytochrome C content, and apoptosis markers were quantified by means of enzyme-linked immunosorbent assay and multiplexing. Compared with control samples, ITCH and Trx1 expression, TXNRD1 amount and activity were reduced and TXNIP expression was increased in ICM (ITCH: P = .013; Trx1: P = .028; TXNRD1 amount: P = .035; TXNRD1 activity: P = .005; TXNIP: P = .014) but not in DCM samples. A higher level of the downstream apoptosis marker caspase-9 (ICM: 582 ± 262 MFI [P = .995]; DCM: 1251 ± 548 MFI [P = .002], control: 561 ± 214 MFI) was detected in DCM tissue. A higher expression of Bcl-2 was found in DCM (P = .011). CONCLUSION: The Trx system was impaired in ICM but not in DCM. ITCH appeared to be responsible for the down-regulation of the Trx system. ROS-induced mitochondrial instability appeared to play a role in DCM.

Thrombelastometry guided blood-component therapy after cardiac surgery: a randomized study.

BACKGROUND: Significant bleeding is a well known complication after cardiac surgical procedures and is associated with worse outcome. Thrombelastometry (ROTEM®) allows point-of-care testing of the coagulation status but only limited data is available yet. The aim was to evaluate the ROTEM®-guided blood component therapy in a randomized trial. METHODS: In case of significant postoperative bleeding (> 200 ml/h) following elective isolated or combined cardiac surgical procedures (including 14% re-do procedures and 4% requiring circulatory arrest) patients were randomized to either a 4-chamber ROTEM®-guided blood-component transfusion protocol or received treatment guided by an algorithm based on standard coagulation testing (control). One hundred four patients (mean age: 67.2 ± 10.4 years, mean log. EuroSCORE 7.0 ± 8.8%) met the inclusion criteria. Mean CPB-time was 112.1 ± 55.1 min., mean cross-clamp time 72.5 ± 39.9 min. RESULTS: Baseline demographics were comparable in both groups. Overall there was no significant difference in transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate was comparable (ROTEM®: 29% vs. control: 25%). However, there was a trend towards less 24-h drainage loss visible in the ROTEM®-group (ROTEM®: 1599.1 ± 834.3 ml vs. control: 1867.4 ± 827.4 ml; p = 0.066). In the subgroup of patients with long CPB-times (> 115 min.; n = 55) known to exhibit an increased risk for diffuse coagulopathy ROTEM®-guided treatment resulted in a significantly lower 24-h drainage loss (ROTEM®: 1538.2 ± 806.4 ml vs. control: 2056.8 ± 974.5 ml; p = 0.032) and reduced 5-year mortality (ROTEM®: 0% vs. control: 15%; p = 0.03). CONCLUSION: In case of postoperative bleeding following cardiac surgical procedures a treatment algorithm based on "point-of-care" 4-chamber ROTEM® seems to be at least as effective as standard therapy. In patients with long CPB-times ROTEM®-guided treatment may result in less bleeding, a marked reduction in costs and long-term mortality. TRIAL REGISTRATION: German Clinical Trials Register, TRN: DRKS00017367 , date of registration: 05.06.2019, 'retrospectively registered'.

Differences of early immunological responses in on-pump versus off-pump cardiac surgery.

INTRODUCTION: Cardiopulmonary bypass surgery is accompanied by an inflammatory response and pulmonary dysfunction that renders patients vulnerable to postoperative complications. The majority of studies investigating the inflammatory response in cardiopulmonary bypass focus on cytokine measurements. This study investigated the early response of peripheral blood cell types and early changes in lung tissue in on-pump versus off-pump cardiopulmonary bypass surgery. METHODS: Landrace pigs were assigned to the following groups (n = 6 per group): 1. off-pump cardiopulmonary bypass, 2. conventional cardiopulmonary bypass, 3. heparin-coated cardiopulmonary bypass, 4. surface-reduced cardiopulmonary bypass, and 5. surface-reduced cardiopulmonary bypass plus lung perfusion. Surgery was performed under mild hyperthermia (32°C), with 90-minute ischemia and 180-minute reperfusion. Histological and flow cytometric analyses were performed. RESULTS: Lung water content increased during reperfusion in heparin-coated (84.63 ± 2.99%) compared to conventional cardiopulmonary bypass (76.33 ± 4.56%, p = 0.04). Alveolar septal thickness increased during ischemia at heparin-coated (p < 0.01) and surface-reduced cardiopulmonary bypass plus lung perfusion (p = 0.05). Tumor necrosis factor expression increased significantly (p < 0.01) in peribronchial, perivascular, and peripheral lung areas in all on-pump groups, but not in off-pump cardiopulmonary bypass. The usage of heparin-coated cardiopulmonary bypass led to increased percentages of CD3+CD4+ (p = 0.03) and CD3+CD8+ (p = 0.01) T cells compared to an uncoated device. Natural killer and mature B lymphocytes decreased at conventional and surface-reduced cardiopulmonary bypass plus lung perfusion. Activated granulocytes and macrophages increased at conventional cardiopulmonary bypass and heparin-coated cardiopulmonary bypass. CONCLUSION: Off-pump cardiopulmonary bypass induces less immunological response and lung injury than on-pump surgery. The reduction of cardiopulmonary bypass surface reduces the inflammatory immune response induced by cardiopulmonary bypass. Lung perfusion of surface-reduced cardiopulmonary bypass diminished the extravasation caused by surface reduction of the cardiopulmonary bypass.

The Ubiquitin Proteasome System in Ischemic and Dilated Cardiomyopathy.

Dilated (DCM) and ischemic cardiomyopathies (ICM) are associated with cardiac remodeling, where the ubiquitin-proteasome system (UPS) holds a central role. Little is known about the UPS and its alterations in patients suffering from DCM or ICM. The aim of this study is to characterize the UPS activity in human heart tissue from cardiomyopathy patients. Myocardial tissue from ICM (n = 23), DCM (n = 28), and control (n = 14) patients were used to quantify ubiquitinylated proteins, E3-ubiquitin-ligases muscle-atrophy-F-box (MAFbx)/atrogin-1, muscle-RING-finger-1 (MuRF1), and eukaryotic-translation-initiation-factor-4E (eIF4E), by Western blot. Furthermore, the proteasomal chymotrypsin-like and trypsin-like peptidase activities were determined fluorometrically. Enzyme activity of NAD(P)H oxidase was assessed as an index of reactive oxygen species production. The chymotrypsin- (p = 0.71) and caspase-like proteasomal activity (p = 0.93) was similar between the groups. Trypsin-like proteasomal activity was lower in ICM (0.78 ± 0.11 µU/mg) compared to DCM (1.06 ± 0.08 µU/mg) and control (1.00 ± 0.06 µU/mg; p = 0.06) samples. Decreased ubiquitin expression in both cardiomyopathy groups (ICM vs. control: p < 0.001; DCM vs. control: p < 0.001), as well as less ubiquitin-positive deposits in ICM-damaged tissue (ICM: 4.19% ± 0.60%, control: 6.28% ± 0.40%, p = 0.022), were detected. E3-ligase MuRF1 protein expression (p = 0.62), NADPH-oxidase activity (p = 0.63), and AIF-positive cells (p = 0.50). Statistical trends were detected for reduced MAFbx protein expression in the DCM-group (p = 0.07). Different levels of UPS components, E3 ligases, and UPS activation markers were observed in myocardial tissue from patients affected by DCM and ICM, suggesting differential involvement of the UPS in the underlying pathologies.

Indication-specific immunomodulatory effects of extracorporeal photopheresis: A pilot study in heart transplanted patients.

BACKGROUND: The clinical use of extracorporeal photopheresis (ECP) is based on its ability to induce cell-mediated immune tolerance towards foreign and self-antigens. Up-to-date, no clear consensus consists on how to use ECP after heart transplantation (HTx). In this pilot study, we evaluated the stimulatory effects of ECP on immune cells in HTx patients. METHODS: HTx patients received ECP therapy as prophylaxis of rejection (PRX, n = 15), to treat acute cellular rejection (ACR, n = 13) or cardiac allograft vasculopathy (CAV, n = 5). Three ECP cycles with monthly frequency were performed. Blood samples were taken before every ECP cycle and 2 months after the last ECP cycle and were analyzed for cytokines and the tolerance-inducing cell subsets regulatory T cells (Tregs ), myeloid (mDCs), and plasmacytoid dendritic cells (pDCs). RESULTS: While ECP treatment induced first an increase of pDCs in the CAV group (baseline: 22.0% ± 9.6%, prior third ECP cycle: 8.6% ± 3.2%, follow-up: 31.5% ± 8.4%, P = .009), no significant changes of DC subsets and Tregs were observed in the ACR- and in the PRX group. Furthermore, analysis of the immune balance showed different response profiles of pro- and anti-inflammatory cytokines among prophylactically ECP-treated patients and ECP-treated patients suffering from CAV or ACR. CONCLUSIONS: In our pilot study, we showed different stimulatory effects of ECP on pDCs and cytokines among prophylactic and therapeutic ECP therapy after HTx. Immunological monitoring should be included in a larger clinical study of ECP treatment following HTx and to identify predictable parameters for ECP efficacy.

Extracorporeal membrane oxygenation: experience in acute graft failure after heart transplantation.

INTRODUCTION: Acute graft failure is the leading cause of early mortality after heart transplantation (HTx). Extracorporeal membrane oxygenation (ECMO) is an efficient therapeutic option to treat various pathologies, unburden the left and right ventricle, and allow for functional recovery of the transplanted heart. We reviewed our ECMO experience and outcomes in HTx patients. METHODS: Retrospectively, we analyzed all patients who received an orthotopic HTx (n = 298) in our department over a 15-yr period (1997 through 2011) to assess the incidence of post-HTx ECMO implantation, perioperative complications, early and one-yr mortality as well as causes of death. RESULTS: ECMO therapy was utilized to treat graft failure in 28 patients (10.6%) with a mean duration of ECMO support of 4.2 d (six h to 9.4 d). Multivariate analysis revealed as independent predictors for mortality low cardiac output (p = 0.028; odds ratio (OR) = 11.3) and stroke (p = 0.008; OR = 19.7). Cumulative survival rates were 46.4 ± 9.4% within 30 d and 25.0 ± 8.2% at one yr. Causes of death were multiorgan failure (n = 9), sepsis (n = 9), lung failure (n = 2), and intracerebral bleeding (n = 2). ECMO was implanted due to primary graft failure (PGF, n = 16), sepsis (n = 4), and right heart failure (n = 6). CONCLUSION: Temporary ECMO support for postoperative output failure is an acceptable option as a last resort for otherwise doomed patients with fatal graft failure after HTx. The small fraction of patients surviving appear to have a decent long-term prognosis.

Prosthesis-patient mismatch after transcatheter aortic valve implantation using the Edwards SAPIEN™ prosthesis.

OBJECTIVES: Prosthesis-patient mismatch (PPM) is defined as a too small effective orifice area (EOA) of the prosthetic valve in relation to the patient's body size and has been documented to be related to adverse outcomes after conventional aortic valve replacement (AVR). Aim of this study was to analyze the incidence of PPM after transcatheter aortic valve implantation (T-AVI) using the Edwards SAPIEN prosthesis and its relation to postoperative outcome. METHODS: 200 consecutive high-risk patients underwent transapical aortic valve implantation (TA-AVI) between February 2006 and January 2009 and fulfilled 1 year follow-up were included. Severe PPM was defined as indexed EOA (EOAi) <0.65 cm2/m2 and moderate PPM as EOAi = 0.65-0.85 cm2/m2, EOA was calculated from transthoracic echocardiographic (TTE) measurements using the continuity equation. Total 112 patients with sufficient postoperative TTE image quality formed the study group. RESULTS: EOAi increased from 0.3 ± 0.1 cm2/m2 (preoperatively) to 1.1 ± 0.4 cm2/m2 after TA-AVI (p < 0.001). According to the standard definitions, PPM was seen in 38.4% of the patients and 9.8% presented with severe PPM. The occurrence of PPM had neither an effect on clinical outcome in terms of NYHA class nor on survival. Patients with PPM had significantly higher postoperative transprosthetic gradients (mean gradient 10.4 ± 4.1 versus 7.1 ± 3.0 mm Hg, p < 0.001). Based on the in vitro EOA data obtained from pulse duplicator measurements, however, none of the patients was judged to have PPM. CONCLUSION: Transcatheter AVI provides good antegrade hemodynamic function and EOAi improves significantly. According to standardized evaluations PPM occurs after TA-AVI, but it is not associated with adverse outcomes. Thus use of the continuity equation may not adequately reflect the situation after T-AVI or the current definition of PPM is not suitable for T-AVI prostheses.

Perioperative temporary mechanical circulatory support with Impella in cardiac surgery patients.

BACKGROUND: The benefits of perioperative mechanical circulatory support (MCS) in cardiac surgery patients are still uncertain. This study aims to review early outcomes of perioperative temporary MCS using the Impella device in cardiac surgery patients. METHODS: Retrospective, single-center analysis in cardiac surgery patients presenting with cardiogenic shock (CS) in whom Impella was used for perioperative temporary MCS, either as single device therapy or as left ventricular (LV) venting strategy for concomitant extracorporeal membrane oxygenation (ECPELLA). Study outcomes were 30-day mortality and occurrence of complication composite outcome. RESULTS: Between 2016 and 2019, a total of 33 consecutive patients were supported with Impella (single-device therapy in 19 [57.6%] patients and ECPELLA in 14 [42.4%] patients). The 30-day mortality of Impella-alone and ECPELLA groups was 15.8% and 50.0% (P=0.03). The 30-day mortality according to pre-, intra-, and postoperative implantation was 12.5%, 60.0%, and 28.6% (P=0.04), and it was significantly lower in those patients in whom a left ventricular assist device was implanted in comparison to all other surgical procedures (P<0.01). The complication composite outcome occurred more frequently after axillary implantation compared to femoral Impella (P=0.05) due to higher stroke rates (P=0.03). Bleeding requiring surgical re-exploration was more frequent in the ECPELLA than in the Impella-alone group (1 [3.0%] vs. 5 [15.1%]; P=0.03). CONCLUSIONS: Temporary MCS with Impella is associated with high complication and mortality rates. However, preoperative use of Impella as single-device temporary MCS is associated with lower mortality rates and is a reasonable alternative as a bridge-to-decision strategy for acutely decompensated patients.

Ten-year follow up after prospectively randomized evaluation of stentless versus conventional xenograft aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: The aim of this prospectively randomized study was to analyze the long-term clinical results after stentless versus conventional aortic valve replacement (AVR). METHODS: Between March 1996 and April 1998, a total of 225 patients was prospectively included into the study. Of these patients, 130 received a stentless aortic valve (SAV), and 95 a conventional stented bioprosthesis (CSB). In these patient groups, 95% and 96%, respectively, had an aortic stenosis, and the mean ages were 71 +/- 7 and 74 +/- 4 years, respectively. There were no significant inter-group differences in left ventricular function, preoperative pressure gradient, or NYHA functional status, and the aortic annulus diameter indices were comparable (13.5 mm in SAV patients versus 13.6 mm in CSB). Larger SAVs were implanted by using an oversizing technique. RESULTS: The 10-year follow up was 98% complete (mean follow up 102 +/- 48.5 months). At follow up the mean NYHA class was 1.7 +/- 0.8 after SAV versus 1.9 +/- 0.7 after CSB, the left ventricular ejection fraction was 61 +/- 11% versus 60 +/- 8%, and the maximum aortic valve pressure gradient 19.4 +/- 8.7 mmHg versus 24.7 +/- 7.7 mmHg (p = 0.03). The 10-year survival was 54 +/- 4.4% (SAV) versus 46 +/- 5.1% (CSB) (p = NS). In a subanalysis to obtain age-matched patient samples, the 10-year survival was 64 +/- 4.9% after SAV versus 46 +/- 5.1% after CSB (p = 0.02). Among the surviving patients, 78% were satisfied with the procedure because of an improved ability to perform their daily activities, and an improved quality of life. CONCLUSION: A good functional and hemodynamic outcome was observed at 10 years after xenograft AVR. Stentless AVR was associated with a trend to a better survival; however, a regression of left ventricular hypertrophy occurred in all patients after AVR.

Embolic occlusion of the left main coronary artery following an isolated aortic valve replacement.

Coronary occlusion after aortic valve replacement due to embolization is a rare complication. We report the case of a patient who developed acute heart failure due to occlusion of the left main coronary artery following an aortic valve replacement. Successful treatment was achieved with emergent coronary bypass surgery.

30-Day perioperative mortality following venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock in patients with normal preoperative ejection fraction.

OBJECTIVES: Assessment of early outcomes in patients with normal preoperative left ventricular ejection fraction (LVEF) in whom venoarterial extracorporeal membrane oxygenation (VA-ECMO) was implanted for postcardiotomy cardiogenic shock (PCCS) during the first postoperative 48 h. METHODS: Retrospective single-centre analysis in adult patients with normal LVEF, who received VA-ECMO support for PCCS from May 1998 to May 2018. The primary outcome was 30-day perioperative mortality during the index hospitalization. RESULTS: A total of 62 125 adult patients underwent cardiac surgery at our institution during the study period. Among them, 173 patients (0.3%) with normal preoperative LVEF required VA-ECMO for PCCS. Among them, 71 (41.1%) patients presented PCCS due to coronary malperfusion and in 102 (58.9%) patients, no evident cause was found for PCCS. Median duration of VA-ECMO support was 5 days (interquartile range 2-8 days). A total of 135 (78.0%) patients presented VA-ECMO-related complications and the overall 30-day perioperative mortality was 57.8%. Independent predictors of mortality were: lactate level just before VA-ECMO implantation [odds ratio (OR) 1.27; P < 0.001], major bleeding during VA-ECMO (OR 3.76; P = 0.001), prolonged cardiopulmonary bypass time (OR 1.01; P < 0.001) and female gender (OR 4.87; P < 0.001). CONCLUSIONS: Mortality rates of VA-ECMO in PCCS patients are high, even in those with preoperative normal LVEF. Coronary problems are an important cause of PCCS; however, the aetiology remains unknown in the vast majority of the cases. The implantation of VA-ECMO before development of tissue hypoperfusion and the control of VA-ECMO-associated complications are the most important prognostic factors in PCCS patients. Lactate levels may help guide timing of VA-ECMO implantation and define the extent of therapeutic effort.