Infectious complications following major heart surgery from the day of the surgery to hospital discharge.

BACKGROUND: At some point in their lives, many people will require major heart surgery (MHS). Patients are generally older adults with various risk factors for infection. However, the incidence of infection after MHS is poorly known, as reported infection data are frequently biased due to different factors like the surgical procedure, postoperative timing, and infectious syndromes or etiologic agents, among others. In addition, most patient data are retrospectively obtained. PURPOSE AND METHODS: Data were prospectively collected regarding the incidence of all nosocomial infections produced from the time of surgery to hospital discharge in a cohort of 800 adults consecutively undergoing a MHS procedure. RESULTS: During postoperative hospitalization, 124 of the 800 participants developed one or more infections (15.5%): during their ICU stay in 68 patients (54.8%), during their stay on the general ward post ICU in 50 (40.3%), and during their stay in both wards in 6 (4.8%). The most common infections were pneumonia (related or not to mechanical ventilation), surgical site and bloodstream. As etiological agents, 193 pathogens were isolated: mostly Gram-negative bacilli (54.4%), followed by Gram-positive bacteria (30%), viruses (4.6%) and fungi (1.5%). In our cohort, all-cause mortality was recorded in 33 participants (4.1%) and 9 infection-related deaths (1.1%) were produced. Among subjects who developed infections, overall mortality was 13.7% and in those who did not, this was only 2.3%. CONCLUSION: Infection following MHS remains frequent and severe. Our data suggest that hospital-acquired infection studies should consider episodes of infection in all populations during their entire hospital stay and not only those related to specific clinical syndromes or acquired while the patient is in intensive care.

Student survey after ten years of continuous blended teaching of echocardiography.

OBJECTIVE: To analyse the impact of 10 years of blended echocardiography teaching. METHODS AND RESULTS: A questionnaire was emailed to all medical doctors who graduated from the blended learning diploma in echocardiography developed by the University of Chile and taught by a team from Chile and Spain. One hundred and forty of the 210 students who graduated from the program between 2011 and 2020 completed the questionnaire: 53.57% were anaesthesiologists, and 26.42% were intensivists. More than 85% of respondents indicated that the online teaching met their expectations, and 70.2% indicated that the hands-on practice fulfilled the stated objectives. In a retrospective analysis using self-reported data, graduates reported that their use of transthoracic and transoesophageal echocardiography has increased from 24.29% to 40.71% and from 13.57% to 27.86%, repectively, after the programme compared to before the programme. They used echocardiography mainly in the perioperative period (56.7%) and during intensive care (32.3%), while only 11% of respondents used it in emergency care units. Nearly all (92.4%) respondents reported that the skills learned was very useful in their professional practice. CONCLUSIONS: Ten years after its launch, the blended learning diploma in echocardiography was well rated by graduate specialists, and is associated with a significant increase in the use of echocardiography in the perioperative period and during intensive care. The main challenges are to establish a longer period of practice and achieve greater implantation in emergency medicine.

Lung and blood perioperative metalloproteinases in patients undergoing oncologic lung surgery: Prognostic implications.

BACKGROUND: Metalloproteinases (MMPs) have been reported to be related to oncologic outcomes. The main goal of the study was to study the relationship between these proteins and the long-term prognosis of patients undergoing oncologic lung resection surgery. METHODS: This was a substudy of the phase IV randomized control trial (NCT02168751). We analyzed MMP-2, -3, -7, and -9 in blood samples and bronchoalveolar lavage (LBA) and the relationship between MMPs and long postoperative outcomes (survival and disease-free time of oncologic recurrence). RESULTS: Survival was longer in patients who had lower MMP-2 levels than those with higher MMP-2 in blood samples taken 6 h after surgery (6.8 vs. 5.22 years; p = 0.012) and MMP-3 (6.82 vs. 5.35 years; p = 0.03). In contrast, survival was longer when MMP-3 levels were higher in LBA from oncologic lung patients than those with lower MMP-3 (7.96 vs. 6.02 years; p = 0.005). Recurrence-free time was longer in patients who had lower MMP-3 levels in blood samples versus higher (5.97 vs. 4.23 years; p = 0.034) as well as lower MMP-7 (5.96 vs. 4.5 years; p = 0.041) or lower MMP-9 in LBA samples (6.21 vs. 4.18 years; p = 0.012). CONCLUSION: MMPs were monitored during the perioperative period of oncologic lung resection surgery. These biomarkers were associated with mortality and recurrence-free time. The role of the different MMPs analyzed during the study do not have the same prognostic implications after this kind of surgery.

Feasibility of using KardiaMobile-L6 for QT interval monitoring during the early phase of the COVID-19 pandemic in critical care patients.

The electrocardiogram (ECG) represents an essential tool to determine cardiac electrical abnormalities in COVID-19 patients, the effects of anti-SARS-CoV-2 drugs, and potential drug interactions. Smartphone-based heart monitors have increased the spectrum of ECG monitoring however, we are not aware of its reliability in critically ill COVID-19 patients. We aim to evaluate the feasibility and reliability of nurse-performed smartphone electrocardiography for QT interval monitoring in critically ill COVID-19 patients using KardiaMobile-6L compared with the standard 12-lead ECG. An observational comparative study was conducted comparing consecutive KardiaMobile-6L and 12-lead ECG recordings obtained from 20 patients admitted to the intensive care unit with SARS-CoV-2 infection and on invasive mechanical ventilation. The heart rate-corrected QT (QTc) intervals measured by KardiaMobile-6L and 12-lead ECG were compared. In 60 percent of the recordings, QTc intervals measured by KardiaMobile-6L matched those by 12-lead ECG. The QTc intervals measured by KardiaMobile-6 and 12-lead ECG were 428 ± 45 ms and 425 ± 35 ms (p = 0.82), respectively. The former demonstrated good agreement (bias = 2.9 ms; standard deviation of bias = 29.6 ms) with the latter, using the Bland-Altman method of measurement agreement. In all but one recording, KardiaMobile-6L demonstrated QTc prolongation. QTc interval monitoring with KardiaMobile-6L in critically ill COVID-19 patients was feasible and demonstrated reliability comparable to the standard 12-lead ECG.

COVID-19 associated infections in the ICU setting: A retrospective analysis in a tertiary-care hospital.

INTRODUCTION: Our work describes the frequency of superinfections in COVID-19 ICU patients and identifies risk factors for its appearance. Second, we evaluated ICU length of stay, in-hospital mortality and analyzed a subgroup of multidrug-resistant microorganisms (MDROs) infections. METHODS: Retrospective study conducted between March and June 2020. Superinfections were defined as appeared ≥48h. Bacterial and fungal infections were included, and sources were ventilator-associated lower respiratory tract infection (VA-LRTI), primary bloodstream infection (BSI), secondary BSI, and urinary tract infection (UTI). We performed a univariate analysis and a multivariate analysis of the risk factors. RESULTS: Two-hundred thirteen patients were included. We documented 174 episodes in 95 (44.6%) patients: 78 VA-LRTI, 66 primary BSI, 9 secondary BSI and 21 UTI. MDROs caused 29.3% of the episodes. The median time from admission to the first episode was 18 days and was longer in MDROs than in non-MDROs (28 vs. 16 days, p<0.01). In multivariate analysis use of corticosteroids (OR 4.9, 95% CI 1.4-16.9, p 0.01), tocilizumab (OR 2.4, 95% CI 1.1-5.9, p 0.03) and broad-spectrum antibiotics within first 7 days of admission (OR 2.5, 95% CI 1.2-5.1, p<0.01) were associated with superinfections. Patients with superinfections presented respect to controls prolonged ICU stay (35 vs. 12 days, p<0.01) but not higher in-hospital mortality (45.3% vs. 39.7%, p 0.13). CONCLUSIONS: Superinfections in ICU patients are frequent in late course of admission. Corticosteroids, tocilizumab, and previous broad-spectrum antibiotics are identified as risk factors for its development.

COVID-19 associated infections in the ICU setting: A retrospective analysis in a tertiary-care hospital.

Introduction: Our work describes the frequency of superinfections in COVID-19 ICU patients and identifies risk factors for its appearance. Second, we evaluated ICU length of stay, in-hospital mortality and analyzed a subgroup of multidrug-resistant microorganisms (MDROs) infections. Methods: Retrospective study conducted between March and June 2020. Superinfections were defined as appeared ≥48 h. Bacterial and fungal infections were included, and sources were ventilator-associated lower respiratory tract infection (VA-LRTI), primary bloodstream infection (BSI), secondary BSI, and urinary tract infection (UTI). We performed a univariate analysis and a multivariate analysis of the risk factors. Results: Two-hundred thirteen patients were included. We documented 174 episodes in 95 (44.6%) patients: 78 VA-LRTI, 66 primary BSI, 9 secondary BSI and 21 UTI. MDROs caused 29.3% of the episodes. The median time from admission to the first episode was 18 days and was longer in MDROs than in non-MDROs (28 vs. 16 days, p < 0.01). In multivariate analysis use of corticosteroids (OR 4.9, 95% CI 1.4-16.9, p 0.01), tocilizumab (OR 2.4, 95% CI 1.1-5.9, p 0.03) and broad-spectrum antibiotics within first 7 days of admission (OR 2.5, 95% CI 1.2-5.1, p < 0.01) were associated with superinfections. Patients with superinfections presented respect to controls prolonged ICU stay (35 vs. 12 days, p < 0.01) but not higher in-hospital mortality (45.3% vs. 39.7%, p 0.13). Conclusions: Superinfections in ICU patients are frequent in late course of admission. Corticosteroids, tocilizumab, and previous broad-spectrum antibiotics are identified as risk factors for its development.

Introducción: Nuestro trabajo describe la frecuencia de sobreinfecciones en pacientes con COVID-19 en UCI e identifica factores de riesgo asociados con su aparición. Secundariamente, evaluamos la estancia en UCI, mortalidad intrahospitalaria y analizamos un subgrupo de infecciones causadas por microorganismos multirresistentes (MDR). Métodos: Estudio realizado entre marzo y junio de 2020. Definimos como sobreinfección a aquellas que aparecieron ≥48 h del ingreso. Incluimos las causadas por bacterias y hongos y evaluamos la infección respiratoria asociada a la ventilación mecánica (IRAVM), bacteriemia primaria, bacteriemia secundaria e infección del tracto urinario. Se realizó un análisis multivariante de los factores de riesgo. Resultados: Incluimos 213 pacientes, documentándose 174 episodios de sobreinfección en 95 casos (44,6%): IRAVM 78 episodios, bacteriemia primaria 66, bacteriemia secundaria 9 e ITU 21. Los MDR causaron el 29,3% de los episodios. La mediana de tiempo hasta el primer episodio fue de 18 días, siendo mayor en las causadas por MDR vs. no MDR (28 vs. 16, p < 0,01). El análisis multivariante identificó la administración de corticoides (OR 4,9 IC 95% 1,4-16,9), tocilizumab (OR 2,4 IC 95% 1,1-5,9) y antibióticos de amplio espectro (OR 2,5 IC 95% 1,2-5,1) como factores de riesgo asociados. Los pacientes con sobreinfección presentaron una estancia en UCI más prolongada (35 vs. 12 días, p < 0,01) pero no mayor mortalidad intrahospitalaria (45,3% vs. 39,7%, p 0,13). Conclusiones: Las sobreinfecciones en los pacientes con COVID-19 aparecen tardíamente. La administración de corticoides, tocilizumab y antibióticos de amplio espectro se asocia con su aparición.

Prevention, Diagnosis and Management of Post-Surgical Mediastinitis in Adults Consensus Guidelines of the Spanish Society of Cardiovascular Infections (SEICAV), the Spanish Society of Thoracic and Cardiovascular Surgery (SECTCV) and the Biomedical Research Centre Network for Respiratory Diseases (CIBERES).

This is a consensus document of the Spanish Society of Cardiovascular Infections (SEICAV), the Spanish Society of Thoracic and Cardiovascular Surgery (SECTCV) and the Biomedical Research Centre Network for Respiratory Diseases (CIBERES). These three entities have brought together a multidisciplinary group of experts that includes anaesthesiologists, cardiac and cardiothoracic surgeons, clinical microbiologists, infectious diseases and intensive care specialists, internal medicine doctors and radiologists. Despite the clinical and economic consequences of sternal wound infections, to date, there are no specific guidelines for the prevention, diagnosis and management of mediastinitis based on a multidisciplinary consensus. The purpose of the present document is to provide evidence-based guidance on the most effective diagnosis and management of patients who have experienced or are at risk of developing a post-surgical mediastinitis infection in order to optimise patient outcomes and the process of care. The intended users of the document are health care providers who help patients make decisions regarding their treatment, aiming to optimise the benefits and minimise any harm as well as the workload.

Possible unrecognised liver injury is associated with mortality in critically ill COVID-19 patients.

BACKGROUND: Coronavirus disease (COVID-19) with acute respiratory distress syndrome is a life-threatening condition. A previous diagnosis of chronic liver disease is associated with poorer outcomes. Nevertheless, the impact of silent liver injury has not been investigated. We aimed to explore the association of pre-admission liver fibrosis indices with the prognosis of critically ill COVID-19 patients. METHODS: The work presented was an observational study in 214 patients with COVID-19 consecutively admitted to the intensive care unit (ICU). Pre-admission liver fibrosis indices were calculated. In-hospital mortality and predictive factors were explored with Kaplan-Meier and Cox regression analysis. RESULTS: The mean age was 59.58 (13.79) years; 16 patients (7.48%) had previously recognised chronic liver disease. Up to 78.84% of patients according to Forns, and 45.76% according to FIB-4, had more than minimal fibrosis. Fibrosis indices were higher in non-survivors [Forns: 6.04 (1.42) versus 4.99 (1.58), p < 0.001; FIB-4: 1.77 (1.17) versus 1.41 (0.91), p = 0.020)], but no differences were found in liver biochemistry parameters. Patients with any degree of fibrosis either by Forns or FIB-4 had a higher mortality, which increased according to the severity of fibrosis (p < 0.05 for both indexes). Both Forns [HR 1.41 (1.11-1.81); p = 0.006] and FIB-4 [HR 1.31 (0.99-1.72); p = 0.051] were independently related to survival after adjusting for the Charlson comorbidity index, APACHE II, and ferritin. CONCLUSION: Unrecognised liver fibrosis, assessed by serological tests prior to admission, is independently associated with a higher risk of death in patients with severe COVID-19 admitted to the ICU.

Invasive pulmonary aspergillosis in the COVID-19 era: An expected new entity.

OBJECTIVES: Information on the recently COVID-19-associated pulmonary aspergillosis (CAPA) entity is scarce. We describe eight CAPA patients, compare them to colonised ICU patients with coronavirus disease 2019 (COVID-19), and review the published literature from Western countries. METHODS: Prospective study (March to May, 2020) that included all COVID-19 patients admitted to a tertiary hospital. Modified AspICU and European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria were used. RESULTS: COVID-19-associated pulmonary aspergillosis was diagnosed in eight patients (3.3% of 239 ICU patients), mostly affected non-immunocompromised patients (75%) with severe acute respiratory distress syndrome (ARDS) receiving corticosteroids. Diagnosis was established after a median of 15 days under mechanical ventilation. Bronchoalveolar lavage was performed in two patients with positive Aspergillus fumigatus cultures and galactomannan (GM) index. Serum GM was positive in 4/8 (50%). Thoracic CT scan findings fulfilled EORTC/MSG criteria in one case. Isavuconazole was used in 4/8 cases. CAPA-related mortality was 100% (8/8). Compared with colonised patients, CAPA subjects were administered tocilizumab more often (100% vs. 40%, p = .04), underwent longer courses of antibacterial therapy (13 vs. 5 days, p = .008), and had a higher all-cause mortality (100% vs. 40%, p = .04). We reviewed 96 similar cases from recent publications: 59 probable CAPA (also putative according modified AspICU), 56 putative cases and 13 colonisations according AspICU algorithm; according EORTC/MSG six proven and two probable. Overall, mortality in the reviewed series was 56.3%. CONCLUSIONS: COVID-19-associated pulmonary aspergillosis must be considered a serious and potentially life-threatening complication in patients with severe COVID-19 receiving immunosuppressive treatment.

Selective digestive decontamination solution used as "lock therapy" prevents and eradicates bacterial biofilm in an in vitro bench-top model.

BACKGROUND: Most preventing measures for reducing ventilator-associated pneumonia (VAP) are based mainly on the decolonization of the internal surface of the endotracheal tubes (ETTs). However, it has been demonstrated that bacterial biofilm can also be formed on the external surface of ETTs. Our objective was to test in vitro the efficacy of selective digestive decontamination solution (SDDs) onto ETT to prevent biofilm formation and eradicate preformed biofilms of three different microorganisms of VAP. METHODS: We used an in vitro model in which we applied, at the subglottic space of ETT, biofilms of either P. aeruginosa ATCC 15442, or E. coli ATCC 25922, or S. aureus ATCC 29213, and the SDDs at the same time (prophylaxis) or after 72 h of biofilm forming (treatment). ETT were incubated during 5 days with a regimen of 2 h-locks. ETT fragments were analyzed by sonication and confocal laser scanning microscopy to calculate the percentage reduction of cfu and viable cells, respectively. RESULTS: Median (IQR) percentage reduction of live cells and cfu/ml counts after treatment were, respectively, 53.2% (39.4%-64.1%) and 100% (100%-100.0%) for P. aeruginosa, and 67.9% (46.7%-78.7%) and 100% (100%-100.0%) for E. coli. S. aureus presented a complete eradication by both methods. After prophylaxis, there were absence of live cells and cfu/ml counts for all microorganisms. CONCLUSIONS: SDDs used as "lock therapy" in the subglottic space is a promising prophylactic approach that could be used in combination with the oro-digestive decontamination procedure in the prevention of VAP.

Colonization of the nasal airways by Staphylococcus aureus on admission to a major heart surgery operating room: A real-world experience.

INTRODUCTION: Nasal swab culture is used to identify Staphylococcus aureus colonization, as this is a major risk factor for surgical site infection (SSI) in patients who are going to undergo major heart surgery (MHS). We determined nasal carriage of S. aureus in patients undergoing MHS by comparing the yield of a conventional culture with that of a rapid molecular test (Xpert® SA Nasal Complete, Cepheid). METHODS: From July 2015 to April 2017, all patients who were to undergo MHS were invited to participate in the study. We obtained two nasal cultures from each patient just before entering the operating room, independently of a previous test for the determination of nasal colonization by this microorganism performed before surgery. One swab was used for conventional culture in the microbiology laboratory, and the other was used for the rapid molecular test. We defined nasal colonization as the presence of a positive culture for S. aureus using either of the two techniques. All patients were followed up until hospital discharge or death. RESULTS: Overall, 57 out of 200 patients (28.5%) were colonized by S. aureus at the time of surgery. Thirty-three patients had both conventional culture- and PCR-positive results. Twenty-four patients had a negative culture and a positive PCR test. Only twenty-one percent (12/57) of colonized patients had undergone an attempt to decolonise before the surgical intervention. CONCLUSION: A significant proportion of patients undergoing MHS are colonized by S. aureus in the nostrils on entering the operating room. New strategies to prevent SSI by this microorganism are needed. Rapid molecular tests immediately before MHS, followed by immediate decolonisation, must be evaluated. Trial Registration Clinical Trials.gov NCT02640001.

Do lower respiratory tract samples contribute to the assessment of carriage of Staphylococcus aureus in patients undergoing mechanical ventilation after major heart surgery?

Colonization by Staphylococcus aureus is regularly assessed in patients undergoing major heart surgery (MHS). Despite pre-surgical decontamination attempts, a significant proportion of MHS patients remain colonized by S. aureus at the time of surgery. Nasal sampling can be improved by sampling extra-nasal areas. We evaluated whether processing lower respiratory tract (LRT) secretions enhanced the detection of S. aureus after MHS. Following a standard protocol, nasal swabs and LRT aspirates were obtained from all of the study patients at the time of surgery or in the immediate postoperative period. One swab was used for culture in the microbiology laboratory, and a second swab was used for the Xpert SA Nasal Complete assay. According to our definition of colonization (culture positive and/or PCR positive), 31 of 115 patients (26.9%) were colonized at the time of surgery. Among these, LRT samples only were positive in three patients (2.6% of the whole population and 9.7% of the carriers). The remaining 28 were either positive in the nasal sample or positive in both samples. The yield of the detection of colonization by S. aureus by including also LRT samples in patients undergoing MHS is limited and must be balanced with laboratory workload and demands on laboratory personnel. Trial registration: Clinical trials.gov NCT02640001.

Infections in patients after Berlin Heart® EXCOR assist device implantation.

OBJECTIVES: Berlin Heart® EXCOR devices (BHED) are ventricular assist devices (VAD) used mainly as a bridge to heart transplantation (HT) in pediatric population. The aim of our study is to report the infections diagnosed in adult patients undergoing a BHED implantation. METHODS: Adult patients receiving a BHED between Jul 2009 and Oct 2017 at our institution were included. Infections were classified according to the International Society of Heart and Lung Transplantation definitions in VAD-Specific (VAD-S), VAD-Related (VAD-R) and non-VAD (N-VAD). RESULTS: Fifteen patients underwent BHED implantation, which was maintained for a mean of 92 (19-195) days. Infection occurred in 13 patients who developed 36 infectious episodes: 5 VAD-S (5 cannula infections); 8 VAD-R (5 bloodstream infections and 3 mediastinitis) and 24 N-VAD (7 urinary tract infections, 6 Cytomegalovirus diseases and others). Overall, 27 (75%) were bacterial, 7 (19.4%) were viral and there was one (2.7%) fungal infection. Eleven patients underwent HT and all of them developed at least one infection after it. In 3 cases, all VAD-R or VAD-S infections were caused by the same etiology as before HT. Their median time of appearance was on day +6 (3-11) after BHED removal and HT. Overall mortality was 6/15 (40%). None of the deaths were related to VAD Infection. CONCLUSIONS: Infection complicated BHED implantation in 86.7% of the patients. Overall, 13.9% were specific of BHED and 22.2% were related. However, infections did not preclude HT in any case and carried no attributable mortality.

Impact of selective digestive decontamination without systemic antibiotics in a major heart surgery intensive care unit.

PURPOSE: The incidence density of ventilator-associated pneumonia (VAP) is higher in patients undergoing major heart surgery than in other populations, despite the introduction of bundles of preventive measures, because many risk factors are not amenable to intervention. Selective digestive decontamination (SDD) has been shown to be efficacious for decreasing the frequency of VAP, although it has not been incorporated into the routine of most intensive care units. The objective of our study was to evaluate the efficacy of SDD without parenteral antibiotics for preventing VAP in a major heart surgery intensive care unit. METHODS: We compared the incidence of VAP before the introduction of SDD (17 months) and during the 17 months after the introduction of SDD and examined its ecologic influence. RESULTS: The rates of VAP in the overall population before and during the intervention were 16.26/1000 days and 6.80 episodes/1000 days of mechanical ventilation, respectively (P = .01). The rates of VAP in the 173 patients remaining under mechanical ventilation > 48 hours after surgery were, respectively, 25.85/1000 days of mechanical ventilation versus 12.06 episodes/1000 days of mechanical ventilation (P = .04). We found a significant reduction in the number of patients with multidrug-resistant microorganisms (P = .01) in the second period of the study. CONCLUSIONS: Our study shows that SDD without parenteral antibiotics can reduce the incidence of VAP in high-risk patients after major heart surgery, with no significant ecologic influence.

Eradication of P. aeruginosa biofilm in endotracheal tubes based on lock therapy: results from an in vitro study.

BACKGROUND: Despite the several strategies available for the management of biofilm-associated ventilator-associated pneumonia, data regarding the efficacy of applying antibiotics to the subglottic space (SS) are scarce. We created an in vitro model to assess the efficacy of antibiotic lock therapy (ALT) applied in the SS for eradication of Pseudomonas aeruginosa biofilm in endotracheal tubes (ETTs). METHODS: We applied 2 h of ALT to a P. aeruginosa biofilm in ETTs using a single dose (SD) and a 5-day therapy model (5D). We used sterile saline lock therapy (SLT) as the positive control. We compared colony count and the percentage of live cells between both models. RESULTS: The median (IQR) cfu counts/ml and percentage of live cells in the SD-ALT and SD-SLT groups were, respectively, 3.12 × 105 (9.7 × 104-0) vs. 8.16 × 107 (7.0 × 107-0) (p = 0.05) and 53.2% (50.9%-57.2%) vs. 91.5% (87.3%-93.9%) (p < 0.001). The median (IQR) cfu counts/ml and percentage of live cells in the 5D-ALT and 5D-SLT groups were, respectively, 0 (0-0) vs. 3.2 × 107 (2.32 × 107-0) (p = 0.03) and 40.6% (36.6%-60.0%) vs. 90.3% (84.8%-93.9%) (p < 0.001). CONCLUSION: We demonstrated a statistically significant decrease in the viability of P. aeruginosa biofilm after application of 5D-ALT in the SS. Future clinical studies to assess ALT in patients under mechanical ventilation are needed.

Early intravenous immunoglobulin replacement in hypogammaglobulinemic heart transplant recipients: results of a clinical trial.

BACKGROUND: Immunoglobulin G (IgG) hypogammaglobulinemia (HGG) is a risk factor for development of severe infections after heart transplantation. We performed a clinical trial to preliminarily evaluate the efficacy and safety of early administration of intravenous immunoglobulin (IVIG) for prevention of severe infection in heart recipients with post-transplant IgG HGG. METHODS: Twelve heart recipients with IgG HGG detected in a screening phase of the clinical trial (IgG <500 mg/dL) were recruited. Patients received IVIG (Flebogamma 5%), as follows: 2 doses of 200 mg/kg followed by up to 5 additional doses of 300 mg/kg to maintain IgG >750 mg/dL. IgG and specific antibody titers to distinct microorganisms were tested during follow-up. The primary outcome measure was development of severe infection during the study period. Data on the primary outcome were matched with those of 13 recipients with post-transplant HGG who were not included in the clinical trial and with those of 11 recipients who did not develop HGG during the same study period. RESULTS: Mean time to detection of HGG was 15 days. IgG and specific antibody reconstitution (anti-cytomegalovirus, anti-Haemophilus influenza, and anti-hepatitis B surface antigen antibodies) was observed in IVIG-treated patients. Severe infection was detected in 3 of 12 (25%) IVIG-treated recipients, in 10 of 13 (77%) HGG non-IVIG patients, and in 2 of 11 (18%) non-HGG patients (log-rank, 15.31; P=.0005). No severe IVIG-related side effects were recorded. CONCLUSION: Data from this study demonstrate that prophylactic IVIG replacement therapy safely modulates HGG and specific antimicrobial antibodies. Our data also preliminarily suggest that IVIG replacement therapy might decrease the incidence of severe infection in heart recipients with HGG.

Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial.

BACKGROUND: Lock-therapy with antimicrobials has been used for the treatment and prevention of catheter-related bloodstream infections (CR-BSI). Experiences with Ethanol-Locks (E-locks) have included therapeutic interventions with variable results. Patients undergoing Major Heart Surgery (MHS) are a high-risk population for CR-BSI.The aim of this study was to assess the efficacy and tolerance to E-Locks in the prevention of CR-BSI of patients undergoing MHS. METHODS AND FINDINGS: This is an academic, prospective, randomized, non-blinded and controlled clinical trial assessing the incidence of CR-BSI of patients with E-locks (E-lock) and the tolerance to the procedure in comparison with patients receiving conventional catheter-care (CCC). Patients undergoing MHS with intravascular catheters for more than 48 hours were randomly assigned into treatment or control group by a computer-generated list of randomly assigned numbers. In the treatment group, all their catheter lumens were locked with an ethanol solution at 70% for two hours, every three days (E-Locks). The control group received conventional catheter-care (CCC). Overall, 200 patients with 323 catheters were included in the study, which was stopped after 10 months due to adverse events. Of them, 179 catheters (113 patients) had E-Locks and 144 catheters (87 patients) were CCC. Euroscore Surgical Risk in both groups was 4.04 vs 4.07 p = 0.94 respectively. The results for the E-Locks and CCC were as follows: Incidence of CR-BSI/1000 days of exposure 2.1 vs 5.2 (p = 0.33), catheter tip colonization 14 (7.8%) vs 6 (4.2%) patients (p = 0.17), median length of hospital stay, 15 vs 16 days (p = 0.77). Seven patients (6.19%), all in the ethanol branch, had to discontinue the trial due to intolerance or adverse events. CONCLUSIONS: We do not recommend prophylaxis of CR-BSI with ethanol-lock on a routine basis in patients undergoing Major Heart Surgery. TRIAL REGISTRATION: Clinical Trials.gov NCT01229592.