Anna Mara Scandroglio

Effect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial

IMPORTANCE No effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery. OBJECTIVE To determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, double-blind, placebo-controlled, parallel-group study from March 2008 to April 2013 in 19 cardiovascular intensive care units in Italy. We randomly assigned 667 patients admitted to intensive care units after cardiac surgery with early acute kidney injury (≥50% increase of serum creatinine level from baseline or oliguria for ≥6 hours) to receive fenoldopam (338 patients) or placebo (329 patients). We used a computer-generated permuted block randomization sequence for treatment allocation. All patients completed their follow-up 30 days after surgery, and data were analyzed according to the intention-to-treat principle. INTERVENTIONS Continuous infusion of fenoldopam or placebo for up to 4 days with a starting dose of 0.1 μg/kg/min (range, 0.025-0.3 µg/kg/min). MAIN OUTCOMES AND MEASURES The primary end point was the rate of renal replacement therapy. Secondary end points included mortality (intensive care unit and 30-day mortality) and the rate of hypotension during study drug infusion. RESULTS The study was stopped for futility as recommended by the safety committee after a planned interim analysis. Sixty-nine of 338 patients (20%) allocated to the fenoldopam group and 60 of 329 patients (18%) allocated to the placebo group received renal replacement therapy (P = .47). Mortality at 30 days was 78 of 338 (23%) in the fenoldopam group and 74 of 329 (22%) in the placebo group (P = .86). Hypotension occurred in 85 (26%) patients in the fenoldopam group and in 49 (15%) patients in the placebo group (P = .001). CONCLUSIONS AND RELEVANCE Among patients with acute kidney injury after cardiac surgery, fenoldopam infusion, compared with placebo, did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00621790.

Levosimendan for Hemodynamic Support after Cardiac Surgery

BACKGROUND Acute left ventricular dysfunction is a major complication of cardiac surgery and is associated with increased mortality. Meta‐analyses of small trials suggest that levosimendan may result in a higher rate of survival among patients undergoing cardiac surgery. METHODS We conducted a multicenter, randomized, double‐blind, placebo‐controlled trial involving patients in whom perioperative hemodynamic support was indicated after cardiac surgery, according to prespecified criteria. Patients were randomly assigned to receive levosimendan (in a continuous infusion at a dose of 0.025 to 0.2 μg per kilogram of body weight per minute) or placebo, for up to 48 hours or until discharge from the intensive care unit (ICU), in addition to standard care. The primary outcome was 30‐day mortality. RESULTS The trial was stopped for futility after 506 patients were enrolled. A total of 248 patients were assigned to receive levosimendan and 258 to receive placebo. There was no significant difference in 30‐day mortality between the levosimendan group and the placebo group (32 patients [12.9%] and 33 patients [12.8%], respectively; absolute risk difference, 0.1 percentage points; 95% confidence interval [CI], ‐5.7 to 5.9; P=0.97). There were no significant differences between the levosimendan group and the placebo group in the durations of mechanical ventilation (median, 19 hours and 21 hours, respectively; median difference, ‐2 hours; 95% CI, ‐5 to 1; P=0.48), ICU stay (median, 72 hours and 84 hours, respectively; median difference, ‐12 hours; 95% CI, ‐21 to 2; P=0.09), and hospital stay (median, 14 days and 14 days, respectively; median difference, 0 days; 95% CI, ‐1 to 2; P=0.39). There was no significant difference between the levosimendan group and the placebo group in rates of hypotension or cardiac arrhythmias. CONCLUSIONS In patients who required perioperative hemodynamic support after cardiac surgery, low‐dose levosimendan in addition to standard care did not result in lower 30‐day mortality than placebo. (Funded by the Italian Ministry of Health; CHEETAH ClinicalTrials.gov number, NCT00994825.)

Cardiac Index Validation Using the Pressure Recording Analytic Method in Unstable Patients

OBJECTIVE The authors investigated the accuracy and precision of the pressure recording analytic method (PRAM) in cardiac index measurement compared with thermodilution in unstable patients, a setting in which minimally invasive monitoring devices often fail. DESIGN Criterion standard. SETTING Intensive care unit. PATIENTS Thirty-two consecutive patients with low cardiac output syndrome treated with an intra-aortic balloon pump and/or high doses of inotropic drugs but without atrial fibrillation were studied after cardiac surgery. INTERVENTIONS None. Pulmonary and radial artery catheters were already in situ for clinical reasons. MEASUREMENTS AND MAIN RESULTS Four patients (12.5%) were excluded from the study because of artifacts caused by under- or overdamping of the arterial pressure monitoring system. The authors performed 3 injections of the thermal indicator in 5 minutes through the pulmonary artery catheter. Mean cardiac index values of 12 consecutive beats were considered for the PRAM. A significant correlation was found between the cardiac index assessed by thermodilution and PRAM (r = 0.72, p < 0.001). The mean bias between the 2 techniques was 0.072 +/- 0.41 L/min/m(2) with lower and upper 95% limits of confidence of -0.089 and 0.233 L/min/m(2), respectively. The percentage error was 30%. Sufficient agreement between the two techniques was evidenced by the Bland-Altman plot with only two points above the limits of agreement. CONCLUSIONS This study showed that PRAM, a minimally invasive method for cardiac index assessment, is clinically useful even in unstable patients such as those receiving intra-aortic balloon pump and/or ongoing high doses of a inotropic drugs because of a low cardiac output syndrome but without atrial fibrillation.

Cardiac Protection With Volatile Anesthetics in Stenting Procedures

OBJECTIVE Myocardial ischemic damage is reduced by volatile anesthetics in patients undergoing coronary artery bypass graft surgery. The authors tested the hypothesis that low-dose sevoflurane could decrease perioperative myocardial damage, as measured by cTnI release, when compared with placebo, in patients undergoing interventional cardiology procedures. DESIGN A single-blind, randomized controlled trial. SETTING A university hospital. PARTICIPANTS Thirty patients undergoing stenting procedures (May 2005) were included in the present study. INTERVENTIONS The authors randomly assigned 16 patients to breathe sevoflurane (expired end-tidal concentration 1%) and 14 patients to breathe a placebo oxygen/air mix before stenting procedures. MEASUREMENTS AND MAIN RESULTS Postprocedural cardiac troponin I release was measured as a marker of myocardial necrosis. Sixteen patients had detectable cardiac troponin I levels after stenting procedures, with no difference between groups: 10 in the sevoflurane group (16 patients) versus 6 in the placebo group (14 patients) (p = 0.3). No difference in the amount of postprocedural median (interquartile range) cardiac troponin I release was noted between the sevoflurane group, 0.15 (0-4.73) ng/mL, and the placebo group, 0.14 (0-0.87) ng/mL (p = 0.4). CONCLUSIONS Myocardial damage measured by cardiac troponin release was not reduced by the volatile anesthetic sevoflurane during interventional cardiology procedures in this study.

Volatile Agents in Medical and Surgical Intensive Care Units: A Meta-Analysis of Randomized Clinical Trials

OBJECTIVE To comprehensively assess published randomized peer-reviewed studies related to volatile agents used for sedation in intensive care unit (ICU) settings, with the hypothesis that volatile agents could reduce time to extubation in adult patients. DESIGN Systematic review and meta-analysis of randomized trials. SETTING Intensive care units. PARTICIPANTS Critically ill patients. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS The BioMedCentral, PubMed, Embase, and Cochrane Central Register databases of clinical trials were searched systematically for studies on volatile agents used in the ICU setting. Articles were assessed by trained investigators, and divergences were resolved by consensus. Inclusion criteria included random allocation to treatment (volatile agents versus any intravenous comparator, with no restriction on dose or time of administration) in patients requiring mechanical ventilation in the ICU. Twelve studies with 934 patients were included in the meta-analysis. The use of halogenated agents reduced the time to extubation (standardized mean difference = -0.78 [-1.01 to -0.55] hours; p for effect<0.00001; p for heterogeneity = 0.18; I(2) = 32% in 7 studies with 503 patients). Results for time to extubation were confirmed in all subanalyses (eg, medical and surgical patients) and sensitivity analyses. No differences in length of hospital stay, ICU stay, and mortality were recorded. CONCLUSIONS In this meta-analysis of randomized trials, volatile anesthetics reduced time to extubation in medical and surgical ICU patients. The results of this study should be confirmed by large and high-quality randomized controlled studies.

Percutaneous tracheostomy in patients on anticoagulants

Aims: To determine if percutaneous tracheostomy is safe in critically ill patients treated with anticoagulant therapies. Settings and Design: Single-center retrospective study including all the patients who underwent percutaneous dilatational tracheostomy (PDT) placement over a 1-year period in a 14-bed, cardiothoracic and vascular Intensive Care Unit (ICU). Materials and Methods: Patients demographics and characteristics, anticoagulant and antiplatelet therapies, coagulation profile, performed technique and use of bronchoscopic guidance were retrieved. Results: Thirty-six patients (2.7% of the overall ICU population) underwent PDT over the study period. Twenty-six (72%) patients were on anticoagulation therapy, 1 patient was on antiplatelet therapy and 2 further patients received prophylactic doses of low molecular weight heparin. Only 4 patients had normal coagulation profile and were not receiving anticoagulant or antiplatelet therapies. Overall, bleeding of any severity complicated 19% of PDT. No procedure-related deaths occurred. Conclusions: PDT was proved to be safe even in critically ill-patients treated with anticoagulant therapies. Larger prospective studies are needed to confirm our findings.

Surgical management of driveline infections in patients with left ventricular assist devices

Driveline infections in patients with implantable left ventricular assist devices (VAD) carry increasing risk for pump infection, thromboembolic events, decreased quality of life, and increased hospitalization. We report our experience with a surgical technique for refractory driveline infections without mediastinitis consisting of translocation and wrapping of the driveline with greater omentum tissue.

Surgical treatment of mediastinitis with omentoplasty in ventricular assist device patients: report of referral center experience.

Mediastinitis is more frequent in patients with implantable ventricular assist devices (VADs) than in other cardiac surgery patients and carries significant mortality. We report our experience with a stepwise approach including aggressive debridement, jet lavage, vacuum assisted closure dressing, and finally coverage with well-vascularized and immune-active omental flaps in VAD patients with infective mediastinitis. We retrospectively collected and analyzed data of patients with continuous flow VAD who underwent plasty with the omental flap because of mediastinitis at Deutsches Herzzentrum Berlin between January 1, 2008 and October 30, 2015. Eight hundred forty-five patients underwent VAD implantation during the study period. Omentoplasty due to infective mediastinitis was performed in 17 cases. Nine had a HeartWare HVAD as left ventricular assist device (LVAD), three patients had two Heart-Ware HVAD as biventricular assist device (BIVAD), four had a HeartMate II LVAD device, and one patient had a Berlin Heart Incor LVAD. The microorganisms most frequently isolated from the sternal wound were Gram-positive Staphylococcus spp. Four cases of bleeding requiring surgical revision were recorded: three of intraabdominal and one of wound bleeding. Eight patients (47%) survived, whereas the other nine patients (53%) died. Sixteen (94%) required intensive care unit admission, and median hospital stay was 21 (1–182) days. Postoperative renal failure requiring dialysis and septic shock requiring vasopressors were associated with hospital mortality (p = 0.009 and p = 0.05, respectively). Early surgical treatment of mediastinitis after VAD implantation with omentoplasty is a valuable strategy in an otherwise dead-end situation. Bleeding should be meticulously controlled in these anticoagulated and fragile patients.

First in man prolonged pressure-controlled intermittent coronary sinus occlusion to treat refractory left ventricular dysfunction and ischemia with patent epicardial coronary arteries

AIMS Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) intermittently increases the pressure in the cardiac venous outflow tract using a balloon-tipped catheter introduced percutaneously into the coronary sinus. It aims to improve microvascular perfusion in STEMI patients during PCI, thus improving infarct healing. Its successful administration was associated with an improvement in myocardial recovery four months after primary-PCI as compared to control. However, it has never been used in other settings or for a prolonged period. The aim of this study was to report on the feasibility and efficacy of prolonged PICSO to treat refractory LV dysfunction and ischemia. METHODS AND RESULTS Two patients with refractory LV dysfunction and ongoing ischemia with patent epicardial coronary artery and suspected underlying microvascular dysfunction were treated with prolonged off-label PICSO utilization. A medium of 23,990mmHg PICSO quantity (a marker of PICSO therapy performance) was achieved: it was almost fifty times the PICSO quantity previously reported in in short-term PICSO utilization. After PICSO placement, both patients showed significant improvement of myocardial ischemia and recovery of LV systolic function. CONCLUSION Prolonged PICSO utilization was feasible and effective in two patients. These cases highlight a novel application of PICSO technology: redistribution of venous blood and improvement in microvascular perfusion that might be a new target in cases of refractory LV dysfunction and ongoing ischemia in the setting of patent epicardial coronary arteries.

Heart Failure After 5 Years on LVAD: Diagnosis and Treatment of Outflow Graft Obstruction.

HeartWare assist device outflow graft obstruction is an uncommon but severe complication, and it may be because of several reasons. We present a case of recurrence of heart failure in a young patient supported with left ventricular assist device and on the waiting list for heart transplantation. After a complex diagnostic workout, a stenosis of the graft anastomosis was found and successfully stented.