OBJECTIVES: Stroke volume (SV) and cardiac output monitoring is a cornerstone of hemodynamic assessment. Noninvasive technologies are increasingly used in children. This study compared SV measurements obtained by transcutaneous Doppler ultrasound techniques (ultrasonic cardiac output monitor [USCOM]), transthoracic echocardiography jugular (TTE-J), and parasternal (TTE-P) views performed by pediatric intensivists (OP-As) with limited training in cardiac sonography (20 previous examinations) and pediatric cardiologists (OP-Bs) with limited training in USCOM (30 previous examinations) in spontaneously ventilating children. METHODS: A single-center study was conducted in 37 children. Each operator obtained 3 sets of USCOM SV measurements within a period of 3 to 5 minutes, followed with TTE measurements from both apical and jugular views. The investigators were blinded to each other's results to prevent visual and auditory bias. RESULTS: Both USCOM and TTE methods were applicable in 89% of patients. The intraobserver variability of USCOM, TTE-J, and TTE-P were less than 10% in both investigators. The SV measurements by OP-As using USCOM, TTE-J, and TTE-P were 46.15 (25.48) mL, 39.45 (20.65) mL, and 33.42 (16.69) mL, respectively. The SV measurements by OP-Bs using USCOM, TTE-J, and TTE-P were 43.99 (25.24) mL, 38.91 (19.98) mL, and 37.58 (19.81) mL, respectively.The percentage error in SV with USCOM relative to TTE-J was 36% in OP-As and 37% in OP-Bs. The percentage error in SV with TTE-P was 33% relative to TTE-J in OP-As and 21% in OP-Bs. CONCLUSIONS: Our findings show that the methods are not interchangeable because SV values by USCOM are higher in comparison with the SV values obtained by TTE. Both methods have low level of intraobserver variability. The SV measurements obtained by TTE-P were significantly lower compared with the TTE-J for the operator with limited training in echocardiography. The TTE-P requires longer practice compared with the TTE-J; therefore, we recommend to prefer TTE-J to TTE-P for inexperienced operators.
- MeSH
- Child MeSH
- Echocardiography * methods MeSH
- Humans MeSH
- Cardiac Output MeSH
- Monitoring, Physiologic methods MeSH
- Prospective Studies MeSH
- Stroke Volume MeSH
- Ultrasonics * MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Observational Study MeSH
SIGNIFICANCE STATEMENT: Although cytomegalovirus (CMV) infection is an important factor in the pathogenesis of kidney allograft rejection, previous studies have not determined the optimal CMV prevention strategy to avoid indirect effects of the virus. In this randomized trial involving 140 kidney transplant recipients, incidence of acute rejection at 12 months was not lower with valganciclovir prophylaxis (for at least 3 months) compared with preemptive therapy initiated after detection of CMV DNA in whole blood. However, prophylaxis was associated with a lower risk of subclinical rejection at 3 months. Although both regimens were effective in preventing CMV disease, the incidence of CMV DNAemia (including episodes with higher viral loads) was significantly higher with preemptive therapy. Further research with long-term follow-up is warranted to better compare the two approaches. BACKGROUND: The optimal regimen for preventing cytomegalovirus (CMV) infection in kidney transplant recipients, primarily in reducing indirect CMV effects, has not been defined. METHODS: This open-label, single-center, randomized clinical trial of valganciclovir prophylaxis versus preemptive therapy included kidney transplant recipients recruited between June 2013 and May 2018. After excluding CMV-seronegative recipients with transplants from seronegative donors, we randomized 140 participants 1:1 to receive valganciclovir prophylaxis (900 mg, daily for 3 or 6 months for CMV-seronegative recipients who received a kidney from a CMV-seropositive donor) or preemptive therapy (valganciclovir, 900 mg, twice daily) that was initiated after detection of CMV DNA in whole blood (≥1000 IU/ml) and stopped after two consecutive negative tests (preemptive therapy patients received weekly CMV PCR tests for 4 months). The primary outcome was the incidence of biopsy-confirmed acute rejection at 12 months. Key secondary outcomes included subclinical rejection, CMV disease and DNAemia, and neutropenia. RESULTS: The incidence of acute rejection was lower with valganciclovir prophylaxis than with preemptive therapy (13%, 9/70 versus 23%, 16/70), but the difference was not statistically significant. Subclinical rejection at 3 months was lower in the prophylaxis group (13% versus 29%, P = 0.027). Both regimens prevented CMV disease (in 4% of patients in both groups). Compared with prophylaxis, preemptive therapy resulted in significantly higher rates of CMV DNAemia (44% versus 75%, P < 0.001) and a higher proportion of patients experiencing episodes with higher viral load (≥2000 IU/ml), but significantly lower valganciclovir exposure and neutropenia. CONCLUSION: Among kidney transplant recipients, the use of valganciclovir prophylaxis did not result in a significantly lower incidence of acute rejection compared with the use of preemptive therapy. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Optimizing Valganciclovir Efficacy in Renal Transplantation (OVERT Study), ACTRN12613000554763 .
- MeSH
- Antiviral Agents adverse effects MeSH
- Cytomegalovirus Infections * epidemiology MeSH
- Cytomegalovirus genetics MeSH
- Humans MeSH
- Neutropenia * chemically induced complications MeSH
- Transplant Recipients MeSH
- Kidney Transplantation * adverse effects MeSH
- Valganciclovir adverse effects MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccination may fail to sufficiently protect transplant recipients against coronavirus disease 2019 (COVID-19). We retrospectively evaluated COVID-19 in kidney transplant recipients (n = 226) after BNT162b2 mRNA vaccine administration. The control group consisted of unvaccinated patients (n = 194) during the previous pandemic wave. We measured anti-spike protein immunoglobulin G (IgG) levels and cellular responses, using enzyme-linked immunosorbent spot assay, in a prospective cohort after vaccination (n = 31) and recovery from COVID-19 (n = 19). COVID-19 was diagnosed in 37 (16%) vaccinated and 43 (22%) unvaccinated patients. COVID-19 severity was similar in both groups, with patients exhibiting a comparable need for hospitalization (41% vs. 40%, p = 1.000) and mortality (14% vs. 9%, p = .726). Short posttransplant periods were associated with COVID-19 after vaccination (p < .001). Only 5 (16%) patients achieved positive SARS-CoV-2 IgG after vaccination, and 17 (89%, p < .001) recovered from COVID-19 (median IgG levels, 0.6 vs. 52.5 AU/ml, p < .001). A cellular response following vaccination was present in the majority (n = 22, 71%), with an increase in interleukin 2 secreting T cells (p < .001). Despite detectable T cell immunity after mRNA vaccination, kidney transplant recipients remained at a high risk of severe COVID-19. Humoral responses induced by vaccination were significantly lower than that after COVID-19.
- MeSH
- COVID-19 * epidemiology prevention & control MeSH
- Incidence MeSH
- Humans MeSH
- RNA, Messenger MeSH
- mRNA Vaccines MeSH
- Pandemics MeSH
- Transplant Recipients MeSH
- Prospective Studies MeSH
- Antibodies, Viral MeSH
- Retrospective Studies MeSH
- SARS-CoV-2 MeSH
- Vaccines, Synthetic MeSH
- Kidney Transplantation * adverse effects MeSH
- BNT162 Vaccine MeSH
- COVID-19 Vaccines MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
Tonsillectomy is a routine surgery in otorhinolaryngology and the occurrence of postoperative bleeding is not a rare complication. The aim of this retrospective, observational, analytic, cohort study is to compare the incidence of this complication for the most common indications. A group of patients indicated for tonsillectomies for peritonsillar abscess (group I) was compared to a group of patients indicated for chronic and recurrent tonsillitis (group II). There are a lot of pathophysiological differences in patients indicated for acute tonsillectomy for peritonsillar abscess and in patients indicated for elective tonsillectomy for chronic or recurrent tonsillitis. No technique to minimize the risk of bleeding after tonsillectomy has been found and a large part of postoperative bleeding occurs in postoperative home-care, which makes this issue topical. In total, 2842 unilateral tonsillectomies from the years 2014-2019 were included in the study. Bleeding occurred in 10.03% and, surprisingly, despite completely different conditions in the field of surgery (oedema, acute inflammation in peritonsillar abscess), there was no statistically significant difference between incidence of postoperative bleeding in the studied groups (p = 0.9920). The highest incidence of bleeding was found in the patients of group I on the eighth postoperative day, with those aged 20-24 years (p = 0.0235) being the most at risk, and in group II, on the sixth postoperative day, with those aged 25-29 years (p = 0.0128) and 45-49 years (p = 0.0249) being the most at risk.
- MeSH
- Adult MeSH
- Cohort Studies MeSH
- Humans MeSH
- Young Adult MeSH
- Peritonsillar Abscess * epidemiology surgery MeSH
- Retrospective Studies MeSH
- Tonsillectomy * adverse effects MeSH
- Tonsillitis * epidemiology surgery MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Young Adult MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Publication type
- Meeting Abstract MeSH
BACKGROUND/AIM: The lungs are the second most common site of cancer dissemination. The aim of this study was to analyze a cohort of patients operated for pulmonary metastases from colorectal carcinoma over a period of 18 years. PATIENTS AND METHODS: In a group of 104 patients, relations were sought between overall survival or disease-free survival and preoperative levels of selected biomarkers, number of metastases and the condition of the intrathoracic lymphatic nodes. Median observation period was 63 months. RESULTS: The 5-year survival rate was 54.3%. Risk of disease progression and risk of death increases in case of occurrence of 2 or more metastases, affection of intrathoracic lymph nodes and levels of CA 19-9, TPS or CEA above cut-off value. CONCLUSION: Prognostic factors that determine overall survival as well as disease-free survival are the number of metastases, the condition of intrathoracic lymphatic nodes and the preoperative levels of biomarkers.
- MeSH
- Adult MeSH
- Colorectal Neoplasms complications pathology MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Metastasis MeSH
- Lung Neoplasms secondary surgery MeSH
- Prognosis MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: Polyomavirus BK (BKV) infection of the renal allograft causes destructive tissue injury with inflammation and subsequent fibrosis. METHODS: Using a prospective cohort of patients after kidney transplantation performed between 2003 and 2012, we investigated the role of BKV viraemia in the development and progression of interstitial fibrosis and tubular atrophy (IFTA). The primary outcome was moderate-to-severe IFTA assessed by protocol biopsy at 36 months. RESULTS: A total of 207 consecutive recipients were enrolled. Of these, 57 (28%) developed BKV viraemia with 10 (5%) cases of polyomavirus-associated nephropathy (PVAN). Transient (<3 months) BKV viraemia occurred in 70% of patients, and persistent (≥3 months) BKV viraemia in 30%. A high viral load (≥10 000 copies/mL) was detected in 18% and a low viral load (<10 000 copies/mL) in 61%, while the viral load could not be determined in 21%. Moderate-to-severe IFTA was significantly increased in high [71%; odds ratio (OR) = 12.1; 95% confidence interval (CI) 1.62-90.0; P = 0.015] or persistent BKV viraemia (67%; OR = 6.33; 95% CI 1.19-33.7; P = 0.031) with corresponding rise in 'interstitial fibrosis + tubular atrophy' scores. Only patients with transient low BKV viraemia showed similar incidence and progression of IFTA to the no-BKV group. Persistent low BKV viraemia was uncommon yet the progression of fibrosis was significant. Only recipients with PVAN experienced inferior graft survival at 5 years. CONCLUSIONS: These data suggest that only transient low BKV viraemia does not negatively affect the progression of allograft fibrosis in contrast to excessive risk of severe fibrosis after high or persistent BKV viraemia.
- MeSH
- Fibrosis etiology pathology MeSH
- Transplantation, Homologous MeSH
- Tumor Virus Infections complications virology MeSH
- Middle Aged MeSH
- Humans MeSH
- Kidney Diseases etiology pathology MeSH
- Polyomavirus Infections complications virology MeSH
- Graft Survival MeSH
- Disease Progression MeSH
- Prospective Studies MeSH
- Virus Replication MeSH
- Kidney Transplantation adverse effects MeSH
- Viremia complications virology MeSH
- Viral Load * MeSH
- BK Virus isolation & purification pathogenicity MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Research Support, Non-U.S. Gov't MeSH
- MeSH
- Cytomegalovirus Infections * MeSH
- Cytomegalovirus MeSH
- Ganciclovir MeSH
- Humans MeSH
- Valganciclovir MeSH
- Viremia MeSH
- BK Virus * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Letter MeSH
- Comment MeSH
- Research Support, Non-U.S. Gov't MeSH
Polyomavirus BK (BKV) is the cause of polyomavirus-associated nephropathy resulting in premature graft loss. There are limited data regarding the role of cytomegalovirus (CMV) infection and its prevention in developing BKV viremia and PVAN. In a prospective study, we analyzed 207 consecutive renal transplant recipients previously enrolled in 2 randomized trials evaluating different CMV prevention regimens with routine screening for BKV and CMV. Of these, 59 received valganciclovir and 100 valacyclovir prophylaxis; 48 patients were managed by preemptive therapy. At 3 years, the incidence of BKV viremia and PVAN was 28% and 5%, respectively. CMV DNAemia developed in 55% and CMV disease in 6%. Both BKV viremia (42% vs 23% vs 21%, P = .006) and PVAN (12% vs 2% vs 2%, P = .011) were increased in patients treated with valganciclovir prophylaxis compared to valacyclovir and preemptive therapy. Using multivariate Cox proportional hazard regression, valganciclovir prophylaxis was independent predictor of BKV viremia (hazard ratio [HR] = 2.38, P = .002) and PVAN (HR = 4.73, P = .026). In contrast, the risk of subsequent BKV viremia was lower in patients with antecedent CMV DNAemia (HR = 0.50, P = .018). These data suggest valganciclovir prophylaxis may be associated with increased risk of BKV viremia and PVAN. CMV DNAemia did not represent a risk for BKV.
- MeSH
- Kidney Failure, Chronic complications surgery MeSH
- Cytomegalovirus Infections prevention & control MeSH
- Cytomegalovirus MeSH
- Adult MeSH
- Tumor Virus Infections prevention & control MeSH
- Middle Aged MeSH
- Humans MeSH
- Multivariate Analysis MeSH
- Polyomavirus Infections virology MeSH
- Premedication MeSH
- Graft Survival MeSH
- Proportional Hazards Models MeSH
- Prospective Studies MeSH
- Randomized Controlled Trials as Topic MeSH
- Risk Factors MeSH
- Kidney Transplantation adverse effects MeSH
- Valacyclovir therapeutic use MeSH
- Valganciclovir therapeutic use MeSH
- Viremia etiology MeSH
- BK Virus MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
BACKGROUND: Cytomegalovirus (CMV) prophylaxis may prevent CMV indirect effects in renal transplant recipients. This study aimed to compare the efficacy of valganciclovir and valacyclovir prophylaxis for CMV after renal transplantation with the focus on chronic histologic damage within the graft. METHODS: From November 2007 through April 2012, adult renal transplant recipients were randomized, in an open-label, single-center study, at a 1:1 ratio to 3-month prophylaxis with valganciclovir (n = 60) or valacyclovir (n = 59). The primary endpoint was moderate-to-severe interstitial fibrosis and tubular atrophy assessed by protocol biopsy at 3 years evaluated by a single pathologist blinded to the study group. The analysis was conducted in an intention-to-treat population. RESULTS: Among the 101 patients who had a protocol biopsy specimen available, the risk of moderate-to-severe interstitial fibrosis and tubular atrophy was significantly lower in those treated with valganciclovir (22% versus 34%; adjusted odds ratio, 0.31; 95% confidence interval, 0.11-0.90; P = 0.032 by multivariate logistic regression). The incidence of CMV disease (9% versus 2%; P = 0.115) and CMV DNAemia (36% versus 42%; P = 0.361) were not different at 3 years. CONCLUSIONS: Valganciclovir prophylaxis, as compared with valacyclovir, was associated with a reduced risk of moderate-to-severe interstitial fibrosis and tubular atrophy in patients after renal transplantation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12610000016033 ). Registered on September 26, 2007.
- MeSH
- Intention to Treat Analysis MeSH
- Antibiotic Prophylaxis methods MeSH
- Antiviral Agents therapeutic use MeSH
- Cytomegalovirus Infections epidemiology prevention & control MeSH
- Cytomegalovirus drug effects MeSH
- Adult MeSH
- Fibrosis epidemiology prevention & control MeSH
- Transplantation, Homologous adverse effects MeSH
- Incidence MeSH
- Kidney drug effects pathology MeSH
- Middle Aged MeSH
- Humans MeSH
- Kidney Diseases epidemiology prevention & control MeSH
- Graft Survival drug effects MeSH
- Kidney Transplantation * adverse effects statistics & numerical data MeSH
- Valacyclovir therapeutic use MeSH
- Valganciclovir therapeutic use MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Australia MeSH