Combined Organ Transplantation in Patients with Advanced Liver Disease.

Transplantation of the liver in combination with other organs is an increasingly performed procedure. Over the years, continuous improvement in survival could be realized through careful patient selection and refined organ preservation techniques, in spite of the challenges posed by aging recipients and donors, as well as the increased use of steatotic liver grafts. Herein, we revisit the epidemiology, allocation policies in different transplant zones, indications, and outcomes with regard to simultaneous organ transplants involving the liver, that is combined heart-liver, liver-lung, liver-kidney, and multivisceral transplantation. We address challenges surrounding combined organ transplantation such as equity, utility, and logistics of dual organ implantation, but also advantages that come along with combined transplantation, thereby focusing on molecular mechanisms underlying immunoprotection provided by the liver to the other allografts. In addition, the current standing and knowledge of machine perfusion in combined organ transplantation, mostly based on center experience, will be reviewed. Notwithstanding all the technical advances, shortage of organs, and the lack of universal eligibility criteria for certain multi-organ combinations are hurdles that need to be tackled in the future.

Driveline infections in left ventricular assist devices-Incidence, epidemiology, and staging proposal.

BACKGROUND: Driveline infections (DLI) are a serious complication in patients with left ventricular assist devices (LVAD). Apart from the differentiation between superficial and deep DLI, there is no consensus on the classification of the severity of DLI. Little is known about risk factors and typical bacteria causing DLI in centrifugal-flow LVADs. METHODS: In this single-center study with 245 patients, DLI were classified by their local appearance using a modification of a score suggested by the Sharp Memorial group. The driveline exit site was inspected routinely every 6 months. RESULTS: Severe DLI were detected in 34 patients (15%) after 6 months and in 24 patients (22%) after 24 months. The proportion of patients with DLI increased significantly during the follow-up (p = 0.0096). The most common bacteria in local smears were Corynebacterium, coagulase-negative Staphylococcus, and Staphylococcus aureus. Fifty-nine patients were hospitalized more than once for DLI. In these patients, S. aureus was the most common bacterium. It was also the most common bacterium in blood cultures. Higher BMI, no partnership, and a HeartMate 3 device were identified as risk factors for DLI in a multivariable cause-specific Cox regression. CONCLUSION: This study is a standardized analysis of DLI in a large cohort with centrifugal-flow LVADs.

Potential benefits of aortic valve opening in patients with left ventricular assist devices.

BACKGROUND: Aortic regurgitation (AR) is a well-known cause of impaired outcome in patients with centrifugal left ventricular assist devices (cfLVADs). The failure of the aortic valve (AV) to open at least intermittently is associated with cusp remodeling, commissural fusion, and ultimately developing AR. Our aim was to characterize patients in whom AV opening (AVO) was preserved 6 months after implantation and identify determinants related to it. METHODS AND RESULTS: We conducted standardized echocardiography and collected clinical and laboratory tests at the outpatient clinic 6 months after implantation. We classified patients into those showing intermittently opening of the AV, every 2-3 beats, or in every cycle (AVO) and those whose AV was continuously closed (NAVO). From the 219 cfLVAD implanted in our center between March 2018 and January 2020, 156 subjects were alive and on the device after 6 months. In 2 of the reviewed echocardiograms, we could not evaluate the AV. 99 patients (64%) showed AVO compared to 55 (36%) with NAVO. The first presented higher mean arterial pressure (84 ± 10 vs. 77 ± 13 mm Hg, p = 0.002), larger LV end-diastolic diameter (LVEDD 57.5 ± 12 vs. 52.7 ± 13 mm, p = 0.022), a better TAPSE (15 ± 4 vs. 13 ± 4 mm, p = 0.028), and less frequently significant AR than patients with NAVO (moderate/severe AR in 6% vs. in 20%, p = 0.042). In a multiple logistic regression, a lower NYHA Class, a larger LVEDD, and a better LV ejection fraction appeared as significant predictors of AVO. After a median follow-up of 3.2 years, we found no significant impact on survival stratifying patients by AVO (log-rank p = 0.53). CONCLUSION: AVO was associated with better RV function, lower NYHA Class, and a lower rate of significant AR. This could indicate that AVO should be pursued in LVAD patients.

Acute Kidney Injury After Heart Transplantation: Risk Factors and Clinical Outcomes.

OBJECTIVE: Acute kidney injury (AKI) requiring renal-replacement therapy (RRT) after heart transplantation (OHT) is common and impairs outcomes. This study aimed to identify independent donor and recipient risk factors associated with RRT after OHT. DESIGN: A retrospective data analysis. SETTING: Data were collected from clinical routines in a maximum-care university hospital. PARTICIPANTS: Patients who underwent OHT. INTERVENTIONS: The authors retrospectively analyzed data from 264 patients who underwent OHT between 2012 and 2021; 189 patients were eligible and included in the final analysis. MEASUREMENTS AND MAIN RESULTS: The mean age was 48.0 ± 12.3 years, and 71.4% of patients were male. Ninety (47.6%) patients were on long-term mechanical circulatory support (lt-MCS). Posttransplant AKI with RRT occurred in 123 (65.1%) patients. In a multivariate analysis, preoperative body mass index >25 kg/m² (odds ratio [OR] 4.74, p < 0.001), elevated preoperative creatinine levels (OR for each mg/dL increase 3.44, p = 0.004), administration of red blood cell units during transplantation procedure (OR 2.31, p = 0.041) and ischemia time (OR for each hour increase 1.77, p = 0.004) were associated with a higher incidence of RRT. The use of renin-angiotensin-aldosterone system blockers before transplantation was associated with a reduced risk of RRT (OR 0.36, p = 0.013). The risk of mortality was 6.9-fold higher in patients who required RRT (hazard ratio 6.9, 95% CI: 2.1-22.6 p = 0.001). Previous lt-MCS, as well as donor parameters, were not associated with RRT after OHT. CONCLUSIONS: The implementation of guideline-directed medical therapy, weight reduction, minimizing ischemia time (ie, organ perfusion systems, workflow optimization), and comprehensive patient blood management potentially influences renal function and outcomes after OHT.

Undetected Neuromuscular Disease in Patients after Heart Transplantation.

(1) Heart transplantation (HTX) improves the overall survival and functional status of end-stage heart failure patients with cardiomyopathies (CMPs). The majority of CMPs have genetic causes, and the overlap between CMPs and inherited myopathies is well documented. However, the long-term outcome in skeletal muscle function and possibility of an undiagnosed underlying genetic cause of both a cardiac and skeletal pathology remain unknown. (2) Thirty-nine patients were assessed using open and standardized interviews on muscle function, a quality-of-life (EuroQol EQ-5D-3L) questionnaire, and a physical examination (Medical Research Council Muscle scale). Whole-exome sequencing was completed in three stages for those with skeletal muscle weakness. (3) Seven patients (17.9%) reported new-onset muscle weakness and motor limitations. Objective muscle weakness in the upper and lower extremities was seen in four patients. In three of them, exome sequencing revealed pathogenic/likely pathogenic variants in the genes encoding nexilin, myosin heavy chain, titin, and SPG7. (4) Our findings support a positive long-term outcome of skeletal muscle function in HTX patients. However, 10% of patients showed clinical signs of myopathy due to a possible genetic cause. The integration of genetic testing and standardized neurological assessment of motor function during the peri-HTX period should be considered.

Outbreak of Pandoraea commovens Infections among Non-Cystic Fibrosis Intensive Care Patients, Germany, 2019-2021.

Pandoraea spp. are gram-negative, nonfermenting rods mainly known to infect patients with cystic fibrosis (CF). Outbreaks have been reported from several CF centers. We report a Pandoraea spp. outbreak comprising 24 non-CF patients at a large university hospital and a neighboring heart center in Germany during July 2019-December 2021. Common features in the patients were critical illness, invasive ventilation, antimicrobial pretreatment, and preceding surgery. Complicated and relapsing clinical courses were observed in cases with intraabdominal infections but not those with lower respiratory tract infections. Genomic analysis of 15 isolates identified Pandoraea commovens as the genetically most similar species and confirmed the clonality of the outbreak strain, designated P. commovens strain LB-19-202-79. The strain exhibited resistance to most antimicrobial drugs except ampicillin/sulbactam, imipenem, and trimethoprim/sulfamethoxazole. Our findings suggest Pandoraea spp. can spread among non-CF patients and underscore that clinicians and microbiologists should be vigilant in detecting and assessing unusual pathogens.

Fluorescence in situ hybridization and polymerase chain reaction to detect infections of cardiac implantable electronic devices.

AIMS: In patients with infections of cardiac implantable electronic devices (CIEDs), the identification of causative pathogens is complicated by biofilm formations and previous antibiotic therapy. In this work, the impact of an additional fluorescence in situ hybridization (FISH), in combination with polymerase chain reaction and sequencing (FISHseq) was investigated. METHODS AND RESULTS: In 36 patients with CIED infections, FISHseq of explanted devices was performed and compared with standard microbiological cultivation of preoperative and intraoperative samples. The mean age was 61.9 (±16.2) years; 25 (69.4%) were males. Most patients (62.9%) had heart failure with reduced ejection fraction. Infections occurred as endoplastits (n = 26), isolated local generator pocket infection (n = 8), or both (n = 2); CIED included cardiac resynchronization therapy defibrillator (n = 17), implantable cardioverter defibrillator (n = 11), and pacemaker (n = 8) devices. The overall positive FISHseq detection rate was 97%. Intraoperatively, pathogens were isolated in 42 vs. 53% in standard cultivation vs. FISHseq, respectively. In 16 of 17 FISHseq-negative patients, the nucleic acid strain DAPI (4',6-diamidino-2-phenylindole) indicated inactive microorganisms, which were partially organized in biofilms (n = 4) or microcolonies (n = 2). In 13 patients in whom no pathogen was identified preoperatively, standard cultivation and FISHseq identified pathogens in 3 (23%) vs. 8 (62%), respectively. For the confirmation of preoperatively known bacteria, a combined approach was most efficient. CONCLUSION: Fluorescence in situ hybridization sequencing is a valuable tool to detect causative microorganisms in CIED infections. The combination of FISHseq with preoperative cultivation showed the highest efficacy in detecting pathogens. Additional cultivation of intraoperative tissue samples or swabs yielded more confirmation of pathogens known from preoperative culture.

Cardiac radiotherapy transiently alters left ventricular electrical properties and induces cardiomyocyte-specific ventricular substrate changes in heart failure.

AIMS: Ongoing clinical trials investigate the therapeutic value of stereotactic cardiac radioablation (cRA) in heart failure patients with ventricular tachycardia. Animal data indicate an effect on local cardiac conduction properties. However, the exact mechanism of cRA in patients remains elusive. Aim of the current study was to investigate in vivo and in vitro myocardial properties in heart failure and ventricular tachycardia upon cRA. METHODS AND RESULTS: High-density 3D electroanatomic mapping in sinus rhythm was performed in a patient with a left ventricular assist device and repeated ventricular tachycardia episodes upon several catheter-based endocardial radio-frequency ablation attempts. Subsequent to electroanatomic mapping and cRA of the left ventricular septum, two additional high-density electroanatomic maps were obtained at 2- and 4-month post-cRA. Myocardial tissue samples were collected from the left ventricular septum during 4-month post-cRA from the irradiated and borderzone regions. In addition, we performed molecular biology and mitochondrial density measurements of tissue and isolated cardiomyocytes. Local voltage was altered in the irradiated region of the left ventricular septum during follow-up. No change of local voltage was observed in the control (i.e. borderzone) region upon irradiation. Interestingly, local activation time was significantly shortened upon irradiation (2-month post-cRA), a process that was reversible (4-month post-cRA). Molecular biology unveiled an increased expression of voltage-dependent sodium channels in the irradiated region as compared with the borderzone, while Connexin43 and transforming growth factor beta were unchanged (4-month post-cRA). Moreover, mitochondrial density was decreased in the irradiated region as compared with the borderzone. CONCLUSION: Our study supports the notion of transiently altered cardiac conduction potentially related to structural and functional cellular changes as an underlying mechanism of cRA in patients with ventricular tachycardia.

Effect of cardiopulmonary bypass on plasma and erythrocytes oxylipins.

BACKGROUND: Oxylipins, the oxidative metabolites of polyunsaturated fatty acids (PUFAs), serve as key mediators of oxidative stress, inflammatory responses, and vasoactive reactions in vivo. Our previous work has established that hemodialysis affects both long chain fatty acids (LCFAs) and oxylipins in plasma and erythrocytes to varying degrees, which may be responsible for excess cardiovascular complications in end-stage renal disease. In this study, we aimed to determine changes in blood oxylipins during cardiopulmonary bypass (CPB) in patients undergoing cardiac surgery to identify novel biomarkers and potential metabolites of CPB-related complications. We tested the hypothesis that CPB would differentially affect plasma oxylipins and erythrocytes oxylipins. METHODS: We conducted a prospective observational study of 12 patients undergoing elective cardiac surgery with expected CPB procedure. We collected venous and arterial blood samples before CPB, 15 and 45 min after the start of CPB, and 60 min after the end of CPB, respectively. Oxylipins profiling in plasma and erythrocytes was achieved using targeted HPLC-MS mass spectrometry. RESULTS: Our results revealed that most venous plasma diols and hydroxy- oxylipins decreased after CPB initiation, with a continuous decline until the termination of CPB. Nevertheless, no statistically significant alterations were detected in erythrocytes oxylipins at all time points. CONCLUSIONS: CPB decreases numerous diols and hydroxy oxylipins in blood plasma, whereas no changes in erythrocytes oxylipins are observed during this procedure in patients undergoing cardiac surgery. As lipid mediators primarily responsive to CPB, plasma diols and hydroxy oxylipins may serve as potential key biomarkers for CPB-related complications.

Missing the blind spot in a HeartMate 3 LVAD outflow graft obstruction caused by fungal infection.

A patient was admitted in cardiogenic shock and a constant decrease of pump flow requiring combined inotropic support. To evaluate the cause, echocardiography and a ramp test were performed. The results suggested a LVAD related problem - particularly a suspected outflow graft obstruction. Wether CT scan nor angiography confirmed the assumption. However, a post-mortem LVAD examination revealed an outflow obstruction caused by a fungal thrombus formation invisible for standard imaging procedures.

Impact of left ventricular inspection employing cardiopulmonary bypass on outcome after implantation of left ventricular assist device.

BACKGROUND: Cardiopulmonary bypass (CPB) during left ventricular assist device (LVAD) implantation provides circulatory support and allows for safe inspection of the left ventricle (LV), whereas circulatory support by veno-arterial extracorporeal life support (va-ECLS) or off-pump implantation may reduce postoperative bleeding and inflammatory response. METHODS: Retrospective analysis of 616 consecutive adult patients who received an LVAD via median sternotomy between January 1, 2015 and December 31, 2019. All patients undergoing concomitant intracardiac procedures other than closure of persistent foramen ovale or atrial septal defect and redo surgeries were excluded from the analysis. The remaining patients (n = 222) were divided into two groups and 1:1 propensity score-matched regarding preoperative parameters: patients who underwent LVAD implantation with LV inspection employing CPB (CPB group, n = 62) and without LV inspection on va-ECLS or off-pump (non-CPB group, n = 62). RESULTS: The groups were well balanced with regard to preoperative baseline characteristics (standard difference <0.1). Patients in the CPB group required more blood transfusions (median 2 vs. 0 units, p = 0.031) during surgery and in the first 24 h afterwards. The median intensive care unit stay was longer in the CPB group (18 vs. 11 days, p = 0.021). The CPB group showed an absence of perioperative stroke and a smaller number of events per patient-year for postoperative ischemic stroke (0.02 vs. 0.12, p = 0.003). 30-day survival (87% vs. 87.1%) and 1-year survival (80.3% vs. 74%) were similar in both groups (p = 0.78). CONCLUSION: Visual LV inspection on CPB may reduce the risk of postoperative ischemic stroke. Despite the negative effects of employing CPB in lieu of other intraoperative strategies, survival was similar in both groups.

Cardiac remodeling in patients with centrifugal left ventricular assist devices assessed by serial echocardiography.

AIM: The aim of the study was to characterize the remodeling process in a large cohort of patients supported with a centrifugal left ventricular assist device (cfLVAD) by standardized serial echocardiography. METHODS AND RESULTS: From 3/2018 all cfLVAD patients underwent transthoracic echocardiography at 6 and 12 months after implantation using a standardized protocol. A total of 512 echocardiograms were reviewed (216 preoperative, 156 at 6 months, 140 at 12 months). While on cfLVAD support, left ventricular (LV) diameter decreased (p < .001). LV ejection fraction (LVEF) and LV fractional area change improved (p < .001). Potential for cfLVAD explantation (as defined by an LVEF ≥45% and opening of the aortic valve [AV]) was seen in nine patients at 6 and 21 patients at 12 months. The tricuspid annular excursion decreased significantly, while the right ventricular fractional area change did not change. Tricuspid regurgitation (TR) and mitral regurgitation (MR) improved significantly during LVAD support. Opening of the AV was seen in >64% of the patients at 6 months and in 66% at 12 months. Moderate aortic regurgitation (AR) was rare with 3.8% at 6 months but increased with the duration of cfLVAD support (8.5% at 12 months). We found no significant difference in echocardiographic parameters between patients supported with a HeartWare HVAD™ or a HeartMate 3™ device. CONCLUSION: LVAD therapy can lead to reverse LV remodeling and improvement of MR and TR. However, right ventricular function does not improve and prevalence of AR progressively increases during mechanical support.

Cardiac Surgery-Related Acute Kidney Injury _ Risk Factors, Clinical Course, Management Suggestions.

OBJECTIVE: Acute kidney injury (AKI) is a common complication after cardiac surgery (CS). Because a therapeutic regimen remains scarce, the early implementation of preventive strategies is crucial. The authors investigated risk factors and the typical clinical course of CS-associated AKI (CS-AKI) to derive strategies for perioperative clinical routines. DESIGN: Retrospective data analysis. SETTING: The data were collected from clinical routines in a maximum care university hospital. PARTICIPANTS: Patients. INTERVENTIONS: The authors retrospectively analyzed data from 538 patients who underwent CS. MEASUREMENTS AND MAIN RESULTS: The median age of the 466 patients included was 66.6 years; 65.7% were men. AKI occurred in 131 (28.1%) patients, mainly (89.0%) starting postoperatively within 72 hours p. Thirty-one (6.7%) patients showed Kidney Disease Improving Global Outcome AKI stage 3. AKI was significantly more frequent in patients with chronic kidney disease (p < 0.001), emergency admission (p < 0.001), heart failure (p < 0.001), and postoperative complications (p < 0.001). In a multivariate analysis, postoperative CS-AKI risk significantly decreased with each 1 or 10 mL/min preoperative glomerular filtration rate (GFR) (odds ratio, 0.962 and 0.677; 95% confidence interval, 0.947-0.977 and 0.577-0.793; p < 0.001 and p < 0.0001). Only in patients who developed Kidney Disease Improving Global Outcome AKI stage 3, an early postoperative trend to decreased GFR and increased creatinine levels was observed. CONCLUSIONS: Especially in patients with preexisting CKD and signs of CS-AKI occurring on the day of surgery, close monitoring of renal function should be performed for at least 72 hours after CS to detect an onset of AKI early and initiate renal protective strategies. Optimal preoperative fluid management might prevent postoperative AKI.

Safety of Contemporary Heart Failure Therapy in Patients with Continuous-Flow Left Ventricular Assist Devices.

BACKGROUND: Limited data are available concerning the safety, optimal administration and benefits of contemporary heart failure therapy in patients after left ventricular assist device (LVAD) implantation. METHODS: Between 2015 and 2019, 257 patients underwent LVAD implantation and were included in this observational study. Oral heart failure therapy was initiated and uptitrated during the further course. After propensity matching and excluding patients with immediate postoperative treatment in an affiliated center with different medical standards, hospitalization rates and mortality within 12 months after LVAD implantation were compared between 83 patients who received medical therapy including an angiotensin receptor neprilysin inhibitor (ARNI) and 83 patients who did not receive an ARNI. RESULTS: The overall use of heart-failure medications after 12 months was high: prescriptions: beta-blockers, 85%; angiotensin inhibiting drugs, 90% (angiotensin-converting-enzyme inhibitors 30%, angiotensin receptor blockers 23%, ARNI 37%); mineralocorticoid receptor antagonists, 80%. No serious drug-related adverse events occurred. The conditional 1-year survival in the group with ARNIs was 97% (95% CI: 94%-100%) compared to 88% in the group without an ARNI (95% CI: 80%-96%); P = 0.06. CONCLUSIONS: Contemporary heart failure therapy is safe in patients with LVADs. No increase in serious adverse events was seen in patients receiving ARNIs. No significant difference in the conditional 1-year survival was seen between the ARNI group and the nonARNI group.

Validity of the 6-Minute Walk Test in Patients with End-Stage Lung Diseases Wearing an Oronasal Surgical Mask in Times of the COVID-19 Pandemic.

BACKGROUND AND OBJECTIVES: The 6-minute walk test (6MWT), as a clinical assessment tool for functional exercise capacity, is an integral component of lung allocation scores (LASs). In times of the coronavirus disease (COVID-19) pandemic, patients underwent 6MWTs wearing a surgical mask in ambulatory care. We investigated the impact of wearing a mask on 6-minute walk distances (6MWDs). METHOD: 6MWDs of 64 patients with end-stage lung diseases wearing an oronasal surgical mask were retrospectively compared to previously investigated 6MWDs of the same cohort, in a pre-COVID-19 pandemic era, without wearing a mask. Four patients were excluded due to a primary vascular disease, 29 patients due to clinically unstable pulmonary functions, and 1 patient due to a psychiatric disorder. RESULTS: The median age of the patients included was 55 (46-58) years; 15 (48%) were male. Ten (32.2%) were on the Eurotransplant lung transplant waiting list with a median LAS of 34.3 (31.9-36.2). Twenty (64.5%) patients had chronic obstructive pulmonary diseases, 7 (22.6%) had interstitial lung diseases, and 4 (12.9%) had other end-stage lung diseases. The mean 6MWD without versus with wearing a mask was 306.9 (101.9) versus 305.7 (103.8) m, with a mean difference of -1.19 m (95% confidence interval -13.4 to 11.03). The observed difference is statistically equivalent to zero (p < 0.001). No significant differences in 6MWDs were observed between the clinical groups. CONCLUSION: Wearing an oronasal surgical mask did not affect the 6MWDs of patients with advanced lung diseases. Therefore, a masked 6MWT appears to provide a reliable examination of functional exercise capacity in this cohort.

Percutaneous mitral valve repair assisted by a catheter-based circulatory support device in a heart transplant patient.

BACKGROUND: Systemic infections and chronic graft rejection represent common causes of mortality and morbidity in heart transplant patients. In severe cases, cardiogenic shock (CS) may occur and require hemodynamic stabilization with temporary mechanical circulatory support (tempMCS). Under these devastating circumstances, treatment of sequelae of left ventricular dysfunction, such as secondary mitral regurgitation (MR) is challenging, especially when surgical repair is deemed futile. In nontransplant patients, interventional mitral valve repair strategies such as the MitraClip system (Abbott Cardiovascular) have been used to successfully treat secondary MR and allow for weaning from tempMCS. CASE SUMMARY: We report about the first patient in whom profound CS after heart transplantation was stabilized with tempMCS followed by interventional elimination of secondary MR.

Propensity score-based analysis of 30-day survival in cardiogenic shock patients supported with different microaxial left ventricular assist devices.

BACKGROUND AND METHODS: Microaxial left ventricular assist devices are used increasingly for treating cardiogenic shock. We compared the short-term outcome of patients supported with different microaxial devices for cardiogenic shock. A retrospective propensity score-adjusted analysis was performed in cardiogenic shock patients treated with either the Impella CP (n = 64) or the Impella 5.0/5.5 (n = 62) at two tertiary cardiac care centers between 1/14 and 12/19. RESULTS: Patients in the Impella CP group were significantly older (69.6 ± 10.7 vs. 58.7 ± 11.9 years, p = .001), more likely in INTERMACS profile 1 (76.6% vs. 50%, p = .003) and post-C-reactive protein (CPR) (36% vs. 13%, p = .006). The median support time was 2.0 days [0.0, 5.3] in the CP group vs. 8.5 days [4.3, 15.8] in the 5.0/5.5 group (p < .001). The unadjusted 30-day survival was significantly higher in the Impella 5.0/5.5 group (58% vs. 36%, p = .021, odds ratio [OR] for 30-day survival on Impella 5.0/5.5 was 3.68 [95% confidence interval [CI]: [1.46-9.90]], p = .0072). After adjustment, the 30-day survival was similar for both devices (OR: 1.23, 95% CI: [0.34-4.18], p = .744). Lactate levels above 8 mmol/L and preoperative CPR were associated with a significant mortality increase in both cohorts (OR: 10.7, 95% CI: [3.45-47.34], p < .001; OR: 13.2, 95% CI: [4.28-57.89], p < .001, respectively). CONCLUSION: Both Impella devices offer a similar effect with regard to survival in cardiogenic shock patients. Preoperative CPR or lactate levels exceeding 8 mmol/L immediately before implantation have a poor prognosis on Impella CP and Impella 5.0/5.5.

The outcome of patients with peripartum cardiomyopathy and consecutive implantation of a left ventricular assist device.

OBJECTIVES: Peripartum cardiomyopathy (PPCM) is a form of systolic heart failure occurring toward the end of pregnancy or in the period after delivery. Lack of myocardial recovery or therapy-refractory cardiogenic shock are rare complications and left ventricular assist device (LVAD) systems might be used as a life-saving option. The aim of this study was to investigate outcomes of PPCM patients supported with LVAD, registered in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS). METHODS: All patients registered in EUROMACS with a primary diagnosis of PPCM were included in this study. Demographic, preoperative, intraoperative, postoperative, and follow-up data were collected and patients analysed concerning their outcome after initiation of LVAD therapy. RESULTS: Between May 2011 and September 2018, 16 patients with PPCM and consecutive LVAD implantation were enrolled into EUROMACS. The median age of the patient population was 31 (26;41) years with a mean left ventricular ejection fraction (LV-EF) of 15% ± 6%. In-hospital mortality after LVAD implantation was 6% (n = 1). One-year mortality accounted for 13% (n = 2). Six patients (40%) were transplanted with a median support time of 769 (193;1529) days. Weaning of LVAD support due to ventricular recovery was feasible in 3 (20%) patients. CONCLUSION: In patients with severe PPCM, LVAD therapy is associated with considerably low in-hospital mortality, potentially allowing bridging to heart transplantation, or left ventricular recovery. Therefore, durable mechanical support should be considered as a treatment option in this, by nature, young and often otherwise healthy patient population.

Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial.

BACKGROUND: Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. This study assessed whether immediate preoperative treatment could result in reduced perioperative red blood cell (RBC) transfusions and improved outcome. METHODS: In this single-centre, randomised, double-blind, parallel-group controlled study, patients undergoing elective cardiac surgery with anaemia (n=253; haemoglobin concentration (Hb) <120 g/L in women and Hb <130 g/L in men) or isolated iron deficiency (n=252; ferritin <100 mcg/L, no anaemia) were enrolled. Participants were randomly assigned (1:1) with the use of a computer-generated range minimisation (allocation probability 0·8) to receive either placebo or combination treatment consisting of a slow infusion of 20 mg/kg ferric carboxymaltose, 40 000 U subcutaneous erythropoietin alpha, 1 mg subcutaneous vitamin B12, and 5 mg oral folic acid or placebo on the day before surgery. Primary outcome was the number of RBC transfusions during the first 7 days. This trial is registered with ClinicalTrials.gov, number NCT02031289. FINDINGS: Between Jan 9, 2014, and July 19, 2017, 1006 patients were enrolled; 505 with anaemia or isolated iron deficiency and 501 in the registry. The combination treatment significantly reduced RBC transfusions from a median of one unit in the placebo group (IQR 0-3) to zero units in the treatment group (0-2, during the first 7 days (odds ratio 0·70 [95% CI 0·50-0·98] for each threshold of number of RBC transfusions, p=0·036) and until postoperative day 90 (p=0·018). Despite fewer RBC units transfused, patients in the treatment group had a higher haemoglobin concentration, higher reticulocyte count, and a higher reticulocyte haemoglobin content during the first 7 days (p≤0·001). Combined allogeneic transfusions were less in the treatment group (0 [IQR 0-2]) versus the placebo group (1 [0-3]) during the first 7 days (p=0·038) and until postoperative day 90 (p=0·019). 73 (30%) serious adverse events were reported in the treatment group group versus 79 (33%) in the placebo group. INTERPRETATION: An ultra-short-term combination treatment with intravenous iron, subcutaneous erythropoietin alpha, vitamin B12, and oral folic acid reduced RBC and total allogeneic blood product transfusions in patients with preoperative anaemia or isolated iron deficiency undergoing elective cardiac surgery. FUNDING: Vifor Pharma and Swiss Foundation for Anaesthesia Research.

Iron deficiency is associated with higher mortality in patients undergoing cardiac surgery: a prospective study.

BACKGROUND: Iron deficiency is frequent in patients undergoing cardiac surgery. The relevance of iron deficiency, however, is ill defined. Therefore, our study aimed to investigate the impact of iron deficiency (ferritin <100 µg L-1) with or without concomitant anaemia on clinical outcome after cardiac surgery. METHODS: In this prospective observational study, 730 patients undergoing elective cardiac surgery were assigned into four groups according to their iron status and anaemia. Mortality, serious adverse events (SAEs), major cardiac and cerebrovascular events (MACCEs), allogenic blood transfusion requirements, and length of hospital stay were assessed during a 90-day follow-up period. The effect of iron deficiency on these outcomes was first calculated in models adjusting for anaemia only, followed by two multivariate models adjusting for anaemia and either the EuroSCORE II or any possible confounders. RESULTS: The presence of iron deficiency (ferritin <100 µg L-1) was associated with an increase in 90-day mortality from 2% to 5% in patients without anaemia, and from 4% to 14% in patients with anaemia. Logistic regression resulted in an odds ratio of 3.5 (95% confidence interval: 1.5-8.4); P=0.004. The effect persisted in both multivariate models. Moreover, iron deficiency was associated with an increased incidence of SAEs, MACCEs, transfusion, and prolonged hospital stay. CONCLUSIONS: Preoperative iron deficiency (ferritin <100 µg L-1) was independently associated with increased mortality, more SAEs, and prolonged hospital stay after cardiac surgery. These findings underline the importance of preoperative iron deficiency screening in the context of a comprehensive patient blood management programme, and highlight its importance as a research topic in cardiac surgery. CLINICAL TRIAL REGISTRATION: NCT02031289.