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INTRODUCTION: Fractional flow reserve (FFR) has been established as the gold standard in the physiological assessment of coronary obstructions severity. However, the need to insert an intracoronary pressure guidewire is a factor that limits its use. Quantitative flow ratio (QFR) is a method that infers the value of FFR from 3-dimensional quantitative coronary angiography (3D-QCA), eliminating the use of a pressure wire and coronary hyperemia. The present study aims to evaluate the diagnostic accuracy of QFR and 3D-QCA in comparison with FFR for the identification of significant obstructive coronary lesions (FFR ≤.80) and the feasibility to assess QFR in a cohort of patients without dedicated angiographic acquisition. METHODS: Consecutive patients with coronary angiography with moderate obstructive lesions that had previous FFR measurement were evaluated. Validation of QFR was assessed by the area under the curve (AUC) and other statistical tools, using FFR as the reference method. RESULTS: Seventy-five arteries from 69 patients were evaluated. The accuracy of the QFR to detect FFR ≤.80 was 84.0% (95% confidence interval, 75.6-92.4). The correlation and agreement between FFR and QFR were r=0.54 (P<.01) and mean difference was -0.02 ± 0.09 (P=.09), respectively. The AUC of QFR and 3D-QCA identifying stenosis >50% was 0.854 and 0.755, respectively (P=.09). CONCLUSION: QFR demonstrated good accuracy compared with FFR for the assessment of moderate obstructive coronary lesions in an unselected clinical practice population. However, many patients were excluded from the analysis and there was no statistical difference between the receiver operator characteristic curves of the QFR and percent diameter stenosis.
Subject(s)
Coronary Stenosis , Fractional Flow Reserve, Myocardial , Constriction, Pathologic , Coronary Angiography/methods , Coronary Stenosis/diagnosis , Coronary Vessels/diagnostic imaging , Fractional Flow Reserve, Myocardial/physiology , Humans , Predictive Value of Tests , Reproducibility of Results , Severity of Illness IndexABSTRACT
BACKGROUND: Elderly patients may present with visual function impairment after surgery, which may increase the incidence of postoperative delirium and falls and decrease their quality of life. The aim of this study was to assess visual function in elderly patients after long-duration nonocular surgery to determine the incidence and risk factors for visual function impairment after surgery. METHODS: This prospective and observational study included patients aged between 60 and 80 years who had been scheduled for elective nonocular surgery expected to last longer than 120 minutes under general anesthesia. Ocular examinations were performed before surgery, on postoperative day 3 and on postoperative day 21 and consisted of a LogMAR-Snellen chart test, a Jager chart test, biomicroscopy, optical tonometry, ocular motility assessment and fundoscopy. Baseline characteristics of all patients as well as intraoperative and postoperative data were collected. RESULTS: A total of 107 patients were included in the final analysis. Visual function impairment was diagnosed in 21 patients (19.6%) at POD 3. Of those, 7 patients (6.5%) still presented with visual changes at POD 21. On POD 3, compared with that at baseline, visual acuity assessed by the Snellen chart test had decreased in these patients. Significant differences regarding refraction tests and intraocular pressure measures were also found. Multivariable analysis identified diabetes mellitus, duration of surgery, hypotension during anesthesia induction, lower peripheral oxygen saturation at the end of the procedure and body mass index as independent risk factors for postoperative visual impairment. CONCLUSION: In elderly patients undergoing long-duration nonocular procedures under general anesthesia, the incidence of visual function impairment was considerably high. Most patients recovered to baseline visual function, but clinically significant visual changes may still be present 3 weeks after surgery. Obesity, diabetes mellitus, and the duration of surgical and anesthetic techniques appear to increase the risk of visual impairment after surgery.
Subject(s)
Oxygen Saturation , Quality of Life , Aged , Aged, 80 and over , Humans , Incidence , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Risk FactorsABSTRACT
BACKGROUND: The detrimental effects of inotropes are well-known, and in many fields they are only used within a goal-directed therapy approach. Nevertheless, standard management in many centers includes administering inotropes to all patients undergoing cardiac surgery to prevent low cardiac output syndrome and its implications. Randomized evidence in favor of a patient-tailored, inotrope-sparing approach is still lacking. We designed a randomized controlled noninferiority trial in patients undergoing cardiac surgery with normal ejection fraction to assess whether an dobutamine-sparing strategy (in which the use of dobutamine was guided by hemodynamic evidence of low cardiac output associated with signs of inadequate tissue perfusion) was noninferior to an inotrope-to-all strategy (in which all patients received dobutamine). RESULTS: A total of 160 patients were randomized to the dobutamine-sparing strategy (80 patients) or to the dobutamine-to-all approach (80 patients). The primary composite endpoint of 30-day mortality or occurrence of major cardiovascular complications (arrhythmias, acute myocardial infarction, low cardiac output syndrome and stroke or transient ischemic attack) occurred in 25/80 (31%) patients of the dobutamine-sparing group (p = 0.74) and 27/80 (34%) of the dobutamine-to-all group. There were no significant differences between groups regarding the incidence of acute kidney injury, prolonged mechanical ventilation, intensive care unit or hospital length of stay. DISCUSSION: Although it is common practice in many centers to administer inotropes to all patients undergoing cardiac surgery, a dobutamine-sparing strategy did not result in an increase of mortality or occurrence of major cardiovascular events when compared to a dobutamine-to-all strategy. Further research is needed to assess if reducing the administration of inotropes can improve outcomes in cardiac surgery. Trial registration ClinicalTrials.gov, NCT02361801. Registered Feb 2nd, 2015. https://clinicaltrials.gov/ct2/show/NCT02361801.
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BACKGROUND: Acute cellular rejection (ACR) is a major complication after heart transplantation. Endomyocardial biopsy (EMB) remains the gold standard for its diagnosis, but it has concerning complications. We evaluated the usefulness of speckle tracking echocardiography (STE) and biomarkers for detecting ACR after heart transplantation. METHODS: We prospectively studied 60 transplant patients with normal left and right ventricular systolic function who underwent EMB for surveillance 6 months after transplantation. Sixty age- and sex-matched healthy individuals constituted the control group. Conventional echocardiographic parameters, left ventricular global longitudinal, radial and circumferential strain (LV-GLS, LV-GRS and LV-GCS, respectively), left ventricular systolic twist (LV-twist) and right ventricular free wall longitudinal strain (RV-FWLS) were analyzed just before the procedure. We also measured biomarkers at the same moment. RESULTS: Among the 60 studied patients, 17 (28%) had severe ACR (grade ≥ 2R), and 43 (72%) had no significant ACR (grade 0 - 1R). The absolute values of LV-GLS, LV-twist and RV-FWLS were lower in transplant patients with ACR degree ≥ 2 R than in those without ACR (12.5% ± 2.9% vs 14.8% ± 2.3%, p=0.002; 13.9° ± 4.8° vs 17.1° ± 3.2°, p=0.048; 16.6% ± 2.9% vs 21.4%± 3.2%, p < 0.001; respectively), while no differences were observed between the LV-GRS or LV-GCS. All of these parameters were lower in the transplant group without ACR than in the nontransplant control group, except for the LV-twist. Cardiac troponin I levels were significantly higher in patients with significant ACR than in patients without significant ACR [0.19 ng/mL (0.09-1.31) vs 0.05 ng/mL (0.01-0.18), p=0.007]. The combination of troponin with LV-GLS, RV-FWLS and LV-Twist had an area under curve for the detection of ACR of 0.80 (0.68-0.92), 0.89 (0.81-0.93) and 0.79 (0.66-0.92), respectively. CONCLUSION: Heart transplant patients have altered left ventricular dynamics compared with control individuals. The combination of troponin with strain parameters had higher accuracy for the detection of ACR than the isolated variables and this association might select patients with a higher risk for ACR who will benefit from an EMB procedure in the first year after heart transplantation.
Subject(s)
Echocardiography/methods , Graft Rejection/diagnosis , Heart Transplantation , Heart Ventricles/diagnostic imaging , Natriuretic Peptide, Brain/blood , Stroke Volume/physiology , Troponin I/blood , Acute Disease , Adult , Biomarkers/blood , Biopsy , Female , Follow-Up Studies , Graft Rejection/metabolism , Graft Rejection/physiopathology , Heart Ventricles/physiopathology , Humans , Male , Myocardium/metabolism , Myocardium/pathology , Postoperative Period , Prognosis , Prospective Studies , Reproducibility of Results , SystoleABSTRACT
OBJECTIVES: Previous trials suggest that vasopressin may improve outcomes in patients with vasodilatory shock. The aim of this study was to evaluate whether vasopressin could be superior to norepinephrine to improve outcomes in cancer patients with septic shock. DESIGN: Single-center, randomized, double-blind clinical trial, and meta-analysis of randomized trials. SETTING: ICU of a tertiary care hospital. PATIENTS: Two-hundred fifty patients 18 years old or older with cancer and septic shock. INTERVENTIONS: Patients were assigned to either vasopressin or norepinephrine as first-line vasopressor therapy. An updated meta-analysis was also conducted including randomized trials published until October 2018. MEASUREMENTS AND MAIN RESULTS: The primary outcome was all-cause mortality at 28 days after randomization. Prespecified secondary outcomes included 90-days all-cause mortality rate; number of days alive and free of advanced organ support at day 28; and Sequential Organ Failure Assessment score 24 hours and 96 hours after randomization. We also measure the prevalence of adverse effects in 28 days. A total of 250 patients were randomized. The primary outcome was observed in 71 patients (56.8%) in the vasopressin group and 66 patients (52.8%) in the norepinephrine group (p = 0.52). There were no significant differences in 90-day mortality (90 patients [72.0%] and 94 patients [75.2%], respectively; p = 0.56), number of days alive and free of advanced organ support, adverse events, or Sequential Organ Failure Assessment score. CONCLUSIONS: In cancer patients with septic shock, vasopressin as first-line vasopressor therapy was not superior to norepinephrine in reducing 28-day mortality rate.
Subject(s)
Neoplasms/complications , Norepinephrine/therapeutic use , Shock, Septic/complications , Shock, Septic/drug therapy , Vasopressins/therapeutic use , Double-Blind Method , Female , Humans , Male , Middle Aged , Shock, Septic/mortality , Vasoconstrictor Agents/therapeutic useABSTRACT
BACKGROUND: Appropriate use of antimicrobials is essential to improve outcomes in sepsis. The aim of this study was to determine whether the use of a rapid molecular blood test-SeptiFast (SF) reduces the antibiotic consumption through early de-escalation in patients with nosocomial sepsis compared with conventional blood cultures (BCs). METHODS: This was a prospective, randomized, superiority, controlled trial conducted at Sao Paulo Heart Institute in the period October 2012-May 2016. Adult patients admitted to the hospital for at least 48 h with a diagnosis of nosocomial sepsis underwent microorganism identification by both SF test and BCs. Patients randomized into the intervention group received antibiotic therapy adjustment according to the results of SF. Patients randomized into the control group received standard antibiotic adjustment according to the results of BCs. The primary endpoint was antimicrobial consumption during the first 14 days after randomization. RESULTS: A total of 200 patients were included (100 in each group). The intention to treat analysis found no significant differences in median antibiotic consumption. In the subgroup of patients with positive SF and blood cultures (19 and 25 respectively), we found a statistically significant reduction in the median antimicrobial consumption which was 1429 (1071-2000) days of therapy (DOT)/1000 patients-day in the intervention group and 1889 (1357-2563) DOT/1000 patients-day in the control group (p = 0.017), in the median time of antimicrobial de-escalation (8 versus 54 h-p < 0.001), in the duration of antimicrobial therapy (p = 0.039) and in anti-gram-positive antimicrobial costs (p = 0.002). Microorganism identification was possible in 24.5% of patients (45/184) by SF and 21.2% (39/184) by BC (p = 0.45). CONCLUSION: This randomized clinical trial showed that the use of a rapid molecular-based pathogen identification test does not reduce the median antibiotic consumption in nosocomial sepsis. However, in patients with positive microbiological tests, the use of SeptiFast reduced antimicrobial consumption through early de-escalation compared to conventional blood cultures. These results were driven by a reduction in the consumption of antimicrobials used for Gram-positive bacteria. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (NCT01450358) on 12th October 2011.
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OBJECTIVE: To investigate the effects of the administration of 4% albumin on lactated Ringer's, when compared with lactated Ringer's alone, in the early phase of sepsis in cancer patients. DESIGN: Single-center, randomized, double-blind, controlled-parallel trial. SETTING: A tertiary care university cancer hospital. PATIENTS: Cancer patients with severe sepsis or septic shock. INTERVENTIONS: Between October 2014 and December 2016, patients were randomly assigned to receive either bolus of albumin in a lactated Ringer's solution or lactated Ringer's solution alone during the first 6 hours of fluid resuscitation after intensive care medicine (ICU) admission. Primary outcome was defined as death from any cause at 7 days. Secondary outcomes were defined as death from any cause within 28 days, change in Sequence Organ Failure Assessment scores from baseline to day 7, days alive and free of mechanical ventilation, days alive and free of vasopressor, renal replacement therapy during ICU stay, and length of ICU and hospital stay. MEASUREMENTS AND MAIN RESULTS: A total of 360 patients were enrolled in the trial. At 7 days, 46 of 180 patients (26%) died in the albumin group and 40 of 180 (22%) died in the lactated Ringer's group (p = 0.5). At 28 days, 96 of 180 patients (53%) died in the albumin group and 83 of 180 (46%) died in the lactated Ringer's group (p = 0.2). No significant differences in secondary outcomes were observed. CONCLUSIONS: Adding albumin to early standard resuscitation with lactated Ringer's in cancer patients with sepsis did not improve 7-day survival.
Subject(s)
Albumins/administration & dosage , Fluid Therapy , Ringer's Lactate/administration & dosage , Sepsis/therapy , Aged , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Neoplasms/complications , Pilot Projects , Secondary Prevention , Sepsis/complicationsABSTRACT
BACKGROUND: Perioperative goal-directed hemodynamic therapy (GDHT) has been advocated in high-risk patients undergoing noncardiac surgery to reduce postoperative morbidity and mortality. We hypothesized that using cardiac index (CI)-guided GDHT in the postoperative period for patients undergoing high-risk surgery for cancer treatment would reduce 30-day mortality and postoperative complications. METHODS: A randomized, parallel-group, superiority trial was performed in a tertiary oncology hospital. All adult patients undergoing high-risk cancer surgery who required intensive care unit admission were randomly allocated to a CI-guided GDHT group or to a usual care group. In the GDHT group, postoperative therapy aimed at CI ≥ 2.5 L/min/m2 using fluids, inotropes and red blood cells during the first 8 postoperative hours. The primary outcome was a composite endpoint of 30-day all-cause mortality and severe postoperative complications during the hospital stay. A meta-analysis was also conducted including all randomized trials of postoperative GDHT published from 1966 to May 2017. RESULTS: A total of 128 patients (64 in each group) were randomized. The primary outcome occurred in 34 patients of the GDHT group and in 28 patients of the usual care group (53.1% vs 43.8%, absolute difference 9.4 (95% CI, - 7.8 to 25.8); p = 0.3). During the 8-h intervention period more patients in the GDHT group received dobutamine when compared to the usual care group (55% vs 16%, p < 0.001). A meta-analysis of nine randomized trials showed no differences in postoperative mortality (risk ratio 0.85, 95% CI 0.59-1.23; p = 0.4; p for heterogeneity = 0.7; I2 = 0%) and in the overall complications rate (risk ratio 0.88, 95% CI 0.71-1.08; p = 0.2; p for heterogeneity = 0.07; I2 = 48%), but a reduced hospital length of stay in the GDHT group (mean difference (MD) - 1.6; 95% CI - 2.75 to - 0.46; p = 0.006; p for heterogeneity = 0.002; I2 = 74%). CONCLUSIONS: CI-guided hemodynamic therapy in the first 8 postoperative hours does not reduce 30-day mortality and severe complications during hospital stay when compared to usual care in cancer patients undergoing high-risk surgery. TRIAL REGISTRATION: www.clinicaltrials.gov , NCT01946269 . Registered on 16 September 2013.
Subject(s)
Goals , Hemodynamics/drug effects , Neoplasms/surgery , Aged , Aged, 80 and over , Dobutamine/pharmacology , Dobutamine/therapeutic use , Female , Heart Rate/physiology , Hemodynamics/physiology , Humans , Male , Middle Aged , Mortality/trends , Neoplasms/drug therapy , Postoperative Period , Risk , Treatment OutcomeABSTRACT
OBJECTIVES: The aim of this study was to evaluate the efficacy of perioperative intra-aortic balloon pump use in high-risk cardiac surgery patients. DESIGN: A single-center randomized controlled trial and a meta-analysis of randomized controlled trials. SETTING: Heart Institute of São Paulo University. PATIENTS: High-risk patients undergoing elective coronary artery bypass surgery. INTERVENTION: Patients were randomized to receive preskin incision intra-aortic balloon pump insertion after anesthesia induction versus no intra-aortic balloon pump use. MEASUREMENTS AND MAIN RESULTS: The primary outcome was a composite endpoint of 30-day mortality and major morbidity (cardiogenic shock, stroke, acute renal failure, mediastinitis, prolonged mechanical ventilation, and a need for reoperation). A total of 181 patients (mean [SD] age 65.4 [9.4] yr; 32% female) were randomized. The primary outcome was observed in 43 patients (47.8%) in the intra-aortic balloon pump group and 42 patients (46.2%) in the control group (p = 0.46). The median duration of inotrope use (51 hr [interquartile range, 32-94 hr] vs 39 hr [interquartile range, 25-66 hr]; p = 0.007) and the ICU length of stay (5 d [interquartile range, 3-8 d] vs 4 d [interquartile range, 3-6 d]; p = 0.035) were longer in the intra-aortic balloon pump group than in the control group. A meta-analysis of 11 randomized controlled trials confirmed a lack of survival improvement in high-risk cardiac surgery patients with perioperative intra-aortic balloon pump use. CONCLUSIONS: In high-risk patients undergoing cardiac surgery, the perioperative use of an intra-aortic balloon pump did not reduce the occurrence of a composite outcome of 30-day mortality and major complications compared with usual care alone.
Subject(s)
Cardiac Surgical Procedures/mortality , Cardiac Surgical Procedures/methods , Intra-Aortic Balloon Pumping/methods , Postoperative Complications/epidemiology , Aged , Cardiotonic Agents/administration & dosage , Female , Humans , Intensive Care Units , Length of Stay , Male , Middle Aged , Postoperative Complications/mortality , Risk Factors , Single-Blind MethodABSTRACT
Importance: Perioperative lung-protective ventilation has been recommended to reduce pulmonary complications after cardiac surgery. The protective role of a small tidal volume (VT) has been established, whereas the added protection afforded by alveolar recruiting strategies remains controversial. Objective: To determine whether an intensive alveolar recruitment strategy could reduce postoperative pulmonary complications, when added to a protective ventilation with small VT. Design, Setting, and Participants: Randomized clinical trial of patients with hypoxemia after cardiac surgery at a single ICU in Brazil (December 2011-2014). Interventions: Intensive recruitment strategy (n=157) or moderate recruitment strategy (n=163) plus protective ventilation with small VT. Main Outcomes and Measures: Severity of postoperative pulmonary complications computed until hospital discharge, analyzed with a common odds ratio (OR) to detect ordinal shift in distribution of pulmonary complication severity score (0-to-5 scale, 0, no complications; 5, death). Prespecified secondary outcomes were length of stay in the ICU and hospital, incidence of barotrauma, and hospital mortality. Results: All 320 patients (median age, 62 years; IQR, 56-69 years; 125 women [39%]) completed the trial. The intensive recruitment strategy group had a mean 1.8 (95% CI, 1.7 to 2.0) and a median 1.7 (IQR, 1.0-2.0) pulmonary complications score vs 2.1 (95% CI, 2.0-2.3) and 2.0 (IQR, 1.5-3.0) for the moderate strategy group. Overall, the distribution of primary outcome scores shifted consistently in favor of the intensive strategy, with a common OR for lower scores of 1.86 (95% CI, 1.22 to 2.83; P = .003). The mean hospital stay for the moderate group was 12.4 days vs 10.9 days in the intensive group (absolute difference, -1.5 days; 95% CI, -3.1 to -0.3; P = .04). The mean ICU stay for the moderate group was 4.8 days vs 3.8 days for the intensive group (absolute difference, -1.0 days; 95% CI, -1.6 to -0.2; P = .01). Hospital mortality (2.5% in the intensive group vs 4.9% in the moderate group; absolute difference, -2.4%, 95% CI, -7.1% to 2.2%) and barotrauma incidence (0% in the intensive group vs 0.6% in the moderate group; absolute difference, -0.6%; 95% CI, -1.8% to 0.6%; P = .51) did not differ significantly between groups. Conclusions and Relevance: Among patients with hypoxemia after cardiac surgery, the use of an intensive vs a moderate alveolar recruitment strategy resulted in less severe pulmonary complications while in the hospital. Trial Registration: clinicaltrials.gov Identifier: NCT01502332.
Subject(s)
Cardiac Surgical Procedures/adverse effects , Hypoxia/therapy , Oxygen Inhalation Therapy/methods , Postoperative Complications/therapy , Pulmonary Alveoli/physiology , Respiration, Artificial/methods , Severity of Illness Index , Aged , Barotrauma/epidemiology , Blood Pressure/physiology , Critical Care/statistics & numerical data , Female , Heart Rate/physiology , Hospital Mortality , Humans , Hypoxia/etiology , Incidence , Length of Stay , Lung Diseases/prevention & control , Male , Middle Aged , Odds Ratio , Oxygen Inhalation Therapy/statistics & numerical data , Partial Pressure , Positive-Pressure Respiration/methods , Postoperative Complications/prevention & control , Tidal VolumeABSTRACT
BACKGROUND: Vasoplegic syndrome is a common complication after cardiac surgery and impacts negatively on patient outcomes. The objective of this study was to evaluate whether vasopressin is superior to norepinephrine in reducing postoperative complications in patients with vasoplegic syndrome. METHODS: This prospective, randomized, double-blind trial was conducted at the Heart Institute, University of Sao Paulo, Sao Paulo, Brazil, between January 2012 and March 2014. Patients with vasoplegic shock (defined as mean arterial pressure less than 65 mmHg resistant to fluid challenge and cardiac index greater than 2.2 l · min · m) after cardiac surgery were randomized to receive vasopressin (0.01 to 0.06 U/min) or norepinephrine (10 to 60 µg/min) to maintain arterial pressure. The primary endpoint was a composite of mortality or severe complications (stroke, requirement for mechanical ventilation for longer than 48 h, deep sternal wound infection, reoperation, or acute renal failure) within 30 days. RESULTS: A total of 330 patients were randomized, and 300 were infused with one of the study drugs (vasopressin, 149; norepinephrine, 151). The primary outcome occurred in 32% of the vasopressin patients and in 49% of the norepinephrine patients (unadjusted hazard ratio, 0.55; 95% CI, 0.38 to 0.80; P = 0.0014). Regarding adverse events, the authors found a lower occurrence of atrial fibrillation in the vasopressin group (63.8% vs. 82.1%; P = 0.0004) and no difference between groups in the rates of digital ischemia, mesenteric ischemia, hyponatremia, and myocardial infarction. CONCLUSIONS: The authors' results suggest that vasopressin can be used as a first-line vasopressor agent in postcardiac surgery vasoplegic shock and improves clinical outcomes.
Subject(s)
Cardiac Surgical Procedures , Norepinephrine/pharmacology , Postoperative Complications/drug therapy , Shock/drug therapy , Vasoplegia/drug therapy , Vasopressins/pharmacology , Brazil , Double-Blind Method , Female , Humans , Male , Middle Aged , Prospective Studies , Shock/complications , Treatment Outcome , Vasoconstrictor Agents/pharmacology , Vasoplegia/complicationsABSTRACT
OBJECTIVE: The aim of this study was to compare outcomes in patients undergoing cardiac surgery who are aged 60 years or more or less than 60 years after implementation of a restrictive or a liberal transfusion strategy. METHODS: This is a substudy of the Transfusion Requirements After Cardiac Surgery (TRACS) randomized controlled trial. In this subgroup analysis, we separated patients into those aged 60 years or more (elderly) and those aged less than 60 years randomized to a restrictive or a liberal strategy of red blood cell transfusion. The primary outcome was a composite defined as a combination of 30-day all-cause mortality and severe morbidity. RESULTS: Of the 502 patients included in the Transfusion Requirements After Cardiac Surgery study, 260 (51.8%) were aged 60 years or more and 242 (48.2%) were aged less than 60 years and were included in this study. The primary end point occurred in 11.9% of patients in the liberal strategy group and 16.8% of patients in the restrictive strategy group (P = .254) for those aged 60 years or more and in 6.8% of patients in the liberal strategy group and 5.6% of patients in the restrictive strategy group for those aged less than 60 years (P = .714). However, in the older patients, cardiogenic shock was more frequent in patients in the restrictive transfusion group (12.8% vs 5.2%, P = .031). Thirty-day mortality, acute respiratory distress syndrome, and acute renal injury were similar in the restrictive and liberal transfusion groups in both age groups. CONCLUSIONS: Although there was no difference between groups regarding the primary outcome, a restrictive transfusion strategy may result in an increased rate of cardiogenic shock in elderly patients undergoing cardiac surgery compared with a more liberal strategy. Cardiovascular risk of anemia may be more harmful than the risk of blood transfusion in older patients.
Subject(s)
Anemia/therapy , Cardiac Surgical Procedures/adverse effects , Erythrocyte Transfusion/methods , Shock, Cardiogenic/prevention & control , Adult , Age Factors , Aged , Anemia/blood , Anemia/diagnosis , Anemia/mortality , Biomarkers/blood , Brazil , Cardiac Surgical Procedures/mortality , Erythrocyte Transfusion/adverse effects , Erythrocyte Transfusion/mortality , Hematocrit , Hemoglobins/metabolism , Humans , Middle Aged , Prospective Studies , Risk Factors , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/etiology , Shock, Cardiogenic/mortality , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Presently, the use of laparoscopy in advanced ovarian cancer (AOC) is extremely controversial. In the era of neoadjuvant chemotherapy (NACT), endoscopic debulking surgery could be a reasonable alternative for selected patients with primarily unresectable disease. OBJECTIVES: To evaluate the feasibility as well as the operative and oncologic safety of laparoscopic debulking surgery in patients with AOC submitted to NACT. METHODS: This is a pilot observational study on initially unresectable, high-grade serous ovarian cancer treated with a sequence of 6 cycles of carboplatin and paclitaxel followed by debulking surgery performed by laparoscopy (group 1) or laparotomy (group 2). The inclusion criteria were clinical complete response, CA-125 normalization, imaging without disease in critical areas, and optimal cytoreduction. RESULTS: From January 2011 to March 2014, 21 patients were included. Ten women underwent laparoscopy and 11 laparotomy. No epidemiological or oncologic differences were observed between the groups. No surgery-related casualties, intraoperative complications, conversion to laparotomy, or excessive blood loss or transfusion was detected in the laparoscopic procedures. The mean time of operation was 292 min. The length of hospital stay averaged 3.6 days. Two women in group 1 developed relevant complications. After a mean follow-up of 20 months, the recurrence rates were similar, i.e. 80% in group 1 versus 88% in group 2. Although statistical significance was not reached, the mortality related to cancer was considerably higher (20 vs. 0%; p = 0.086) and the mean chemotherapy-free interval was markedly shorter in group 1 (13.3 vs. 20.5 months; p = 0.288). CONCLUSION: Laparoscopic optimal debulking surgery after NACT is feasible and effective in selected patients. Nevertheless, laparoscopy was substantially associated with inferior oncologic results. Endoscopic cytoreduction in AOC should be cautiously suggested until larger prospective trials confirm the observed results.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cytoreduction Surgical Procedures/methods , Gynecologic Surgical Procedures/methods , Laparoscopy/adverse effects , Neoadjuvant Therapy/methods , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/surgery , Adult , Aged , Biomarkers, Tumor/blood , Carboplatin/administration & dosage , Chemotherapy, Adjuvant , Cystadenocarcinoma, Serous/drug therapy , Cystadenocarcinoma, Serous/surgery , Feasibility Studies , Female , Humans , Kaplan-Meier Estimate , Laparoscopy/mortality , Laparotomy , Length of Stay , Middle Aged , Neoplasm Recurrence, Local/prevention & control , Neoplasm Staging , Operative Time , Ovarian Neoplasms/blood , Ovarian Neoplasms/mortality , Ovarian Neoplasms/pathology , Ovarian Neoplasms/prevention & control , Paclitaxel/administration & dosage , Pilot Projects , Population Surveillance/methods , Prospective Studies , Sample Size , Treatment OutcomeABSTRACT
PURPOSE OF REVIEW: Anemia has been demonstrated to be detrimental in several populations such as high-surgical-risk patients, critically ill elderly, and cardiac patients. Red blood cell transfusion is the most commonly prescribed therapy for anemia. Despite being life-saving, it carries a risk that ranges from mild complications to death. The aim of this review is to discuss the risks of anemia and blood transfusion, and to describe recent developments in the strategies to reduce allogeneic blood transfusion. RECENT FINDINGS: In the past decades, clinical studies comparing transfusion strategies in different populations were conducted. Despite the challenges imposed by the development of such studies, evidence-based medicine on transfusion medicine in critically ill patients is being created. Different results arising from these studies reflect population heterogeneity, specific circumstances, and difficulties in measuring the impact of anemia and transfusion in a clinical trial. SUMMARY: An adequate judgment of a clinical condition associated with proper application of the available literature is the cornerstone in the management of transfusion in critical care. Apart from this individualized strategy, the institution of a patient blood management program allows goal-directed approach through preoperative recognition of anemia, surgical efforts to minimize blood loss, and continuous assessment of the coagulation status.
Subject(s)
Blood Transfusion/methods , Blood Transfusion/statistics & numerical data , Anemia/etiology , Erythrocyte Transfusion , Humans , Latin America , Randomized Controlled Trials as Topic , Transfusion ReactionABSTRACT
OBJECTIVE: This study aimed to evaluate the feasibility and safety of laparoscopic extrafascial hysterectomy and bilateral salpingo-oophorectomy after primary chemoradiation (CRT) in patients with locally advanced cervical cancer (LACC) without evidence of nodal metastasis. BACKGROUND: Currently, the standard of care for patients with advanced cervical cancer is concurrent CRT. There is an unequivocal correlation between presence of residual disease and risk of local relapse. Nevertheless, the importance of hysterectomy in adjuvant setting remains controversial. METHODS: Prospective study with patients affected by bulky LACC (International Federation of Gynecology and Obstetrics stage IB2 up to IIB) treated initially with radical CRT who underwent laparoscopic surgery 12 weeks after therapy conclusion. Inclusion criteria were absence of signs for extrapelvic or nodal involvement on initial imaging staging, as well as complete clinical and radiologic response. RESULTS: From January 2011 to March 2013, 33 patients were endoscopically operated. The mean age was 44 years (range, 21-77 years). Histologic finding revealed squamous cell carcinoma in 19 (60%) cases and adenocarcinoma in 14 (40%) cases. International Federation of Gynecology and Obstetrics stages distribution were as follow: 1B2, n = 3 (9%); IIA, n = 4 (11%); and IIB, n = 26 (80%). The mean pretherapeutic tumor size was 5.2 cm (range, 4-10.2 cm). Estimated blood loss was 80 mL (range, 40-150 mL), and mean operative time was approximately 104 minutes (range, 75-130 minutes). No casualty or conversion to laparotomy occurred. Hospital stay was in average 1.7 days (range, 1-4 days). Significant complication occurred in 12% of the cases; 2 vaginal vault dehiscence, 1 pelvic infection, and 1 ureterovaginal fistula. Nine (27%) patients had pathologic residual disease, and in 78% of these cases, histologic finding was adenocarcinoma (P = -0.048). All patients had free margins. After median follow-up of 16 months, all women have no signs of local recurrence. CONCLUSIONS: Laparoscopic extrafascial hysterectomy (completion surgery) after primary CRT in patients with apparent node-negative LACC is a feasible and safe strategy to improve tumor local control mainly in cases of adenocarcinoma.
Subject(s)
Adenocarcinoma/surgery , Carcinoma, Squamous Cell/surgery , Chemoradiotherapy , Hysterectomy, Vaginal/methods , Uterine Cervical Neoplasms/surgery , Adult , Aged , Female , Humans , Laparoscopy/methods , Middle Aged , Prospective Studies , Treatment Outcome , Young AdultABSTRACT
INTRODUCTION: Pulse pressure variation (PPV) has been proposed as a promising resuscitation goal, but its ability to predict fluid responsiveness has been questioned in various conditions. The purpose of this study was to assess the performance of PPV in predicting fluid responsiveness in experimental hemorrhagic shock with endotoxemia, while comparing it with goals determined by a conventional set of guidelines. METHODS: Twenty-seven pigs were submitted to acute hemorrhagic shock with intravenous infusion of endotoxin and randomized to three groups: (i) control; (ii) conventional treatment with crystalloids to achieve and maintain central venous pressure (CVP) 12 to 15 mmHg, mean arterial pressure of 65 mmHg or greater, and SvO2 (mixed venous oxygen saturation) of 65% or greater; (iii) treatment to achieve and maintain PPV of 13% or less. Parametric data were analyzed by two-way analysis of variance and Tukey test and differences in crystalloid volumes by t test. Predictive values of variables regarding fluid responsiveness were evaluated by receiver operating characteristic curves and multiple logistic regression. RESULTS: Both treatments produced satisfactory hemodynamic recovery, without statistical differences in fluid administration (P = 0.066), but conventional treatment induced higher CVP (P = 0.001). Areas under receiver operating characteristic curves were larger for CVP (0.77; 95% confidence interval, 0.68-0.86) and PPV (0.74; 95% confidence interval, 0.65-0.83), and these variables were further selected by multiple logistic regression as independent predictors of responsiveness. Optimal PPV cutoff was 15%, with false-positive results involving mean pulmonary arterial pressure of 27 mmHg or greater. CONCLUSIONS: Acute resuscitation guided by PPV was comparable with the strategy guided by CVP, mean arterial pressure, and SvO2. Central venous pressure and PPV were individually limited but independently predictive of fluid responsiveness.
Subject(s)
Blood Pressure , Central Venous Pressure , Endotoxemia/therapy , Fluid Therapy/methods , Resuscitation/methods , Animals , Female , ROC Curve , Shock, Hemorrhagic/therapy , SwineABSTRACT
OBJECTIVE: The failure to wean from mechanical ventilation is related to worse outcomes after cardiac surgery. The aim of this study was to evaluate whether the serum level of B-type natriuretic peptide is a predictor of weaning failure from mechanical ventilation after cardiac surgery. METHODS: We conducted a prospective, observational cohort study of 101 patients who underwent on-pump coronary artery bypass grafting. B-type natriuretic peptide was measured postoperatively after intensive care unit admission and at the end of a 60-min spontaneous breathing test. The demographic data, hemodynamic and respiratory parameters, fluid balance, need for vasopressor or inotropic support, and length of the intensive care unit and hospital stays were recorded. Weaning failure was considered as either the inability to sustain spontaneous breathing after 60 min or the need for reintubation within 48 h. RESULTS: Of the 101 patients studied, 12 patients failed the weaning trial. There were no differences between the groups in the baseline or intraoperative characteristics, including left ventricular function, EuroSCORE and lengths of the cardiac procedure and cardiopulmonary bypass. The B-type natriuretic peptide levels were significantly higher at intensive care unit admission and at the end of the breathing test in the patients with weaning failure compared with the patients who were successfully weaned. In a multivariate model, a high B-type natriuretic peptide level at the end of a spontaneous breathing trial was the only independent predictor of weaning failure from mechanical ventilation. CONCLUSIONS: A high B-type natriuretic peptide level is a predictive factor for the failure to wean from mechanical ventilation after cardiac surgery. These findings suggest that optimizing ventricular function should be a goal during the perioperative period.