scholarly journals Evaluation of BioFoam for Anastomotic Bleeding in Cardiovascular Surgery

Aorta ◽  
2018 ◽  
Vol 06 (02) ◽  
pp. 053-058
Author(s):  
Ottavio Alfieri
Keyword(s):  
Adverse Events ◽  
Surgical Procedures ◽  
Cardiovascular Surgery ◽  
Autologous Blood ◽  
Operation Time ◽  
Serious Adverse Events ◽  
Anastomotic Bleeding ◽  
Normal Limits ◽  
Alternative Means ◽  
Cardiovascular Surgical Procedures

Background Hemostatic agents are increasingly used as an adjunct to standard methods of controlling anastomotic bleeding in surgical procedures. The purpose of this study was to investigate the safety and effectiveness of BioFoam Surgical Matrix used as an adjunct for anastomotic hemostasis following cardiovascular surgery. Methods A prospective, multicenter, single arm study was conducted with 75 subjects treated with BioFoam following a total of 105 elective cardiovascular surgical procedures. Time to hemostasis was recorded following a single application of BioFoam in 74 subjects. Safety evaluations included intraoperative administration of a blood product, requirement for alternative means to achieve hemostasis, and the incidence of reoperation for bleeding. Results Hemostasis within 3 minutes was achieved in 62 (84%) of the 74 subjects and within 10 minutes in 69 (93%) of these subjects. BioFoam was well tolerated. Twelve (16%) of the 75 enrolled subjects each experienced one adverse event, and 13 serious adverse events were reported in 10 (13.3%) of the subjects. None of the adverse events was considered by the Investigators to be related to BioFoam. Blood products were administered to 14 (18.6%) of the 75 subjects, banked autologous blood was given to 5 (6.6%) subjects, and 57 (75.7%) subjects required only a cell saver. Four (5.3%) of the 75 subjects required reoperation for bleeding within 24 hours of surgery. There were no observations of bleeding in any subject at discharge and no reoperation for bleeding following discharge. The mean operation time was 218.2 (±72.2) minutes. Conclusions This study demonstrates the effectiveness of BioFoam Surgical Matrix when used as an adjunct for anastomotic hemostasis following a broad range of cardiovascular surgical procedures. The safety outcomes were within the normal limits for the types of procedures performed.

scholarly journals Use of laboratory testing for prediction of postoperative bleeding volume in cardiovascular surgery

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Yoshie Kawahara ◽  
Kohei Ohtsuka ◽  
Kimine Tanaka ◽  
Mayumi Yamanaka ◽  
Hiroyuki Kamiya ◽  
...  
Keyword(s):  
Cardiovascular Surgery ◽  
Autologous Blood ◽  
Postoperative Bleeding ◽  
Operation Time ◽  
Massive Bleeding ◽  
Blood Collection ◽  
Laboratory Parameters ◽  
Packed Red Blood Cells ◽  
Post Surgery ◽  
Bleeding Volume

Abstract Background Coagulopathy and following massive bleeding are complications of cardiovascular surgery, particularly occurring after procedures requiring prolonged cardiopulmonary bypass (CPB). Reliable and rapid tests for coagulopathy are desirable for guiding transfusion. Measuring multiple coagulation parameters may prove useful. The purpose of this study is to determine the laboratory parameters predicting massive bleeding. Methods In a prospectively collected cohort of 48 patients undergoing cardiovascular surgery, markers of coagulation and fibrinolysis were measured using automated analyzer and their correlations with bleeding volume were determined. Results Operation time was 318 (107–654) min. CPB time was 181 (58–501) min. Bleeding volume during surgery was 2269 (174–10,607) ml. Number of transfusion units during surgery were packed red blood cells 12 (0–30) units, fresh frozen plasma 12 (0–44) units, platelets 20 (0–60) units and intraoperative autologous blood collection 669 (0–4439) ml. Post-surgery activities of coagulation factors II (FII), FV, FVII, FVIII, FIX, FX, FXI and FXII were decreased. Values of fibrinogen, antithrombin, α2 plasmin inhibitor (α2PI) and FXIII were also decreased. Values of thrombin-antithrombin complex (TAT) were increased. Values of FII, FIX, FXI and α2PI before surgery were negatively correlated with bleeding volume (FII, r = − 0.506: FIX, r = − 0.504: FXI, r = − 0.580; α2PI, r = − 0.418). Level of FIX after surgery was negatively correlated with bleeding volume (r = − 0.445) and level of TAT after surgery was positively correlated with bleeding volume (r = 0.443). Conclusions These results suggest that several clinical and routine laboratory parameters of coagulation were individually associated with bleeding volume during cardiovascular surgery. Determining the patterns of coagulopathy may potentially help guide transfusion during cardiovascular surgery.

Sacubitil/valsartan in systemic right ventricular failure

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Nederend ◽  
T.E Zandstra ◽  
P Kies ◽  
H.W Vliegen ◽  
M.R.M Jongbloed ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Events ◽  
Adult Congenital Heart Disease ◽  
Global Longitudinal Strain ◽  
Serious Adverse Events ◽  
Systemic Right Ventricle ◽  
Normal Limits ◽  
Patients With Heart Failure ◽  
Congenitally Corrected Transposition ◽  
Corrected Transposition

Abstract Background In patients with heart failure with low ejection fraction (EF) (≤35%) sacubitril/valsartan is proven to be beneficial. We aimed to assess the effects of sacubitril/valsartan in adult congenital heart disease patients with failing systemic right ventricle (sRV) in the setting of congenitally corrected transposition of the great arteries (TGA) or TGA after atrial switch. Purpose To evaluate the feasibility and effect of treatment with sacubitril/valsartan in patients with heart failure in the setting of a sRV on optimal medical heart failure treatment. Methods Data of patients with sRV failure (estimated RVEF ≤35%) treated with sacubitril/valsartan were analyzed. Patients were clinically evaluated at baseline and at six months after initiation of the highest tolerated dose. Results Fourteen patients completed six-month follow-up thus far, of which 6 female (42.8%) and 2 (14.3%) with congenitally corrected transposition of the great arteries (TGA). After 6 months, 9 patients (64.3%) were using the highest dose (97/103 mg twice daily) of sacubitril/valsartan. NT-proBNP was significantly lower after 3 months and after 6 months compared with baseline (64% of baseline, p=0.006 and 53% of baseline, p=0.001, respectively). The kidney function did not change significantly (creatinine at baseline 83.6±12.0 and at 6 months 88.5±13.87, p=0.141) and serum potassium remained within normal limits (4.28±0.36 and 4.49±0.30, p=0.007). There was no significant decrease in systolic blood pressure (p=0.960). The echocardiographic sRV fractional area change (FAC) improved (p=0.002) and Global Longitudinal Strain (GLS) showed a trend towards improvement (p=0.058). During the 6 months of treatment, the exercise capacity remained stable, there was no increase in diuretic use, no serious adverse events and no heart failure related admissions occurred. Conclusion Treatment of sRV heart failure patients with sacubitril/valsartan leads to a significant reduction in NT-proBNP and significant increase in FAC. All patients remained clinically stable and no heart failure related admissions or serious adverse events occurred. Changes after 6 months Funding Acknowledgement Type of funding source: None

Use of Perflubron Emulsion to Decrease Allogeneic Blood Transfusion in High-blood-loss Non-Cardiac Surgery

2002 ◽  
Vol 97 (6) ◽  
pp. 1338-1349 ◽  
Author(s):  
Donat R. Spahn ◽  
Klaus F. Waschke ◽  
Thomas Standl ◽  
Johann Motsch ◽  
Léone Van Huynegem ◽  
...  
Keyword(s):  
Blood Loss ◽  
Adverse Events ◽  
Surgical Procedures ◽  
Oxygen Carrier ◽  
Randomized Study ◽  
Acute Normovolemic Hemodilution ◽  
Serious Adverse Events ◽  
Normovolemic Hemodilution ◽  
And Control ◽  
Preoperative Autologous Donation

Background This single-blind randomized study in general surgery evaluated the efficacy of perflubron emulsion (PFC) as an artificial oxygen carrier being used to augment preoperative acute normovolemic hemodilution to reduce and avoid transfusion of both allogeneic erythrocytes and erythrocytes from preoperative autologous donation compared with standard of care. Methods Subjects (N = 492) with hemoglobin concentrations of 12-15 g/dl undergoing noncardiac surgical procedures with 20 ml/kg or greater expected blood loss were randomized into two groups. Control patients were transfused intraoperatively at a hemoglobin concentration less than 8.0 +/- 0.5 g/dl or at protocol-defined, physiologic triggers. PFC-treated patients first underwent acute normovolemic hemodilution to hemoglobin of 8.0 +/- 0.5 g/dl, followed by dosing with perflubron emulsion (1.8 g/kg). When hemoglobin reached less than 6.5 +/- 0.5 g/dl, an additional 0.9-g/kg dose was given. PFC patients were transfused at hemoglobin less than 5.5 +/- 0.5 g/dl or at predefined physiologic triggers. After surgery, hemoglobin was maintained at 8.5 +/- 0.5 g/dl or greater in all patients until discharge. Efficacy endpoints included the number of allogeneic and preoperative autologous donation units transfused and the percentage of subjects avoiding transfusion. Results Both groups had similar hemoglobin concentrations at screening (13.5 +/- 1.0 g/dl) and at discharge: 10.8 +/- 1.2 g/dl (PFC) and 11.1 +/- 1.3 g/dl (control). At 24 h, more patients in the PFC group avoided allogeneic and preoperative autologous donation erythrocyte transfusions (53% vs. 43%, < 0.05), and fewer erythrocytes were transfused (1.5 +/- 4.8 vs. 2.1 +/- 3.9 units; median, 0 vs. 1 unit; P = 0.013). By day of discharge, these differences were not significant in the intent-to-treat population, but overall there were less allogeneic and preoperative autologous donation erythrocyte transfusions in the PFC group (696 vs. 846 units). In the protocol-defined target population (n = 330 subjects with blood loss > or = 20 ml/kg), significantly greater avoidance of any erythrocyte transfusion was maintained through day of hospital discharge (26% vs. 16% in the PFC and control groups, respectively; P < 0.05), and there was also a significant reduction in the number of erythrocyte units transfused (3.4 +/- 2.9 vs. 4.9 +/- 2.4 units; median 2 vs. 4 units; P < 0.001). Adverse events rates were similar in the PFC (86%) and control (81%) groups; however, more serious adverse events were reported in the PFC group (32%) than in controls (21%; P < 0.05). Overall mortality was 3%, and the difference between groups (PFC, 4% vs. controls, 2%) was not statistically significant. Conclusions Augmented acute normovolemic hemodilution with PFC reduces transfusion needs in patients undergoing noncardiac surgical procedures with blood loss 20 ml/kg or greater.

Von Willebrand Factor/Factor VIII Concentrate (Humate-P®) for Surgical Prophylaxis of Excessive Bleeding in Patients with Von Willebrand Disease (VWD).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1791-1791
Author(s):  
Joan Cox Gill ◽  
J. DiPaola ◽  
J. Bernstein ◽  
C. A. Leissinger ◽  
L. Valentino ◽  
...  
Keyword(s):  
Adverse Events ◽  
Surgical Procedures ◽  
Oral Surgery ◽  
Coagulation Factor ◽  
Major Surgery ◽  
Serious Adverse Events ◽  
Excessive Bleeding ◽  
Safety And Efficacy ◽  
Estimated Blood Loss ◽  
Von Willebrand

Abstract Optimal dosing to prevent excessive surgical bleeding in VWD is being investigated in an ongoing prospective, uncontrolled, open-labeled study to establish the safety and efficacy of replacement therapy with a VWF/FVIII concentrate (Humate-P®). This protocol-defined interim analysis describes the results in the first eighteen (18) patients (6 males, 12 females) of a total of 30 planned. Seven patients had Type 1 VWD, 6 had Type 2 (2 with 2A, 3 with 2B, 1 with 2M), and 5 had Type 3. All patients had pre-operative pharmacokinetic assessments to individualize the loading and maintenance doses of VWF/FVIII concentrate utilized for surgery. Fourteen patients had major surgical procedures including neurosurgery, joint replacement, tonsillectomy and complete oral restoration; three had minor procedures; and one had oral surgery. Hemostatic efficacy was assessed by investigators on a four-point scale (excellent, good, moderate/poor, none) immediately after surgery, 24 hours after the last VWF/FVIII concentrate infusion, and 14 days post-op. Good and excellent efficacy were combined into one endpoint of effective hemostasis. Expected estimated blood loss (EBL) was defined prior to the procedure, and actual EBL was recorded post-op. Adverse events were collected throughout the trial until follow-up 4 weeks post-op. Hemostasis was effective in 17/18 patients (94.4%) immediately after surgery; in 17/17 patients (100%) 24 hours after the last VWF/FVIII conc infusion; and in 18/18 (100%) patients 14 days after surgery. Median actual EBL did not exceed expected EBL in any surgery category. Four patients received transfusions (one for pre-existing anemia, three for serious adverse events). Loading doses of VWF/FVIII concentrate ranged from 36 to 135 IU/kg. Maintenance doses were determined by daily monitoring of plasma coagulation factor levels. Median durations of treatment were 2 days for oral surgery, and 4 days for both minor and major surgery. Post-op nausea (n=5) and fever (n=3) were the most commonly reported adverse events. Nausea, headache, and dizziness were considered possibly related to VWF/FVIII concentrate in one patient each; these events were mild in severity and resolved without sequelae. Bleeding-related serious adverse events were reported in three patients: one with GI bleeding post-laparoscopic gastro-jejunal bypass; one with post-craniotomy subdural and intracranial bleeding; and one with post-hysteroscopy/dilatation & curettage hemorrhage followed by hysterectomy. Hemostasis was considered effective in these 3 by the investigators, and in 2 patients by an independent DSMB review; hemostasis was considered ineffective by the DSMB only in the patient with post-hysteroscopy bleeding. No thromboembolic complications or changes in viral titers were observed. This analysis supports VWF/FVIII concentrate safety and efficacy to prevent excessive bleeding during and after a range of surgical procedures in patients with VWD. Enrollment in the trial continues.

Statin-induced adverse effects – facts and genes

2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh
Keyword(s):  
Risk Factors ◽  
Single Nucleotide Polymorphisms ◽  
Adverse Effects ◽  
Adverse Events ◽  
Statin Therapy ◽  
Significant Proportion ◽  
Gene Mutations ◽  
Nucleotide Polymorphisms ◽  
Serious Adverse Events ◽  
Single Nucleotide

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.

Phosphene perceptions and safety of chronic visual cortex stimulation in a blind subject

2020 ◽  
Vol 132 (6) ◽  
pp. 2000-2007 ◽  
Author(s):  
Soroush Niketeghad ◽  
Abirami Muralidharan ◽  
Uday Patel ◽  
Jessy D. Dorn ◽  
Laura Bonelli ◽  
...  
Keyword(s):  
Visual Cortex ◽  
Adverse Events ◽  
Clinical Intervention ◽  
Occipital Cortex ◽  
Neuronal Population ◽  
Serious Adverse Events ◽  
Stimulation Parameters ◽  
The Right ◽  
Visual Cortical ◽  
Stimulation Of

Stimulation of primary visual cortices has the potential to restore some degree of vision to blind individuals. Developing safe and reliable visual cortical prostheses requires assessment of the long-term stability, feasibility, and safety of generating stimulation-evoked perceptions.A NeuroPace responsive neurostimulation system was implanted in a blind individual with an 8-year history of bare light perception, and stimulation-evoked phosphenes were evaluated over 19 months (41 test sessions). Electrical stimulation was delivered via two four-contact subdural electrode strips implanted over the right medial occipital cortex. Current and charge thresholds for eliciting visual perception (phosphenes) were measured, as were the shape, size, location, and intensity of the phosphenes. Adverse events were also assessed.Stimulation of all contacts resulted in phosphene perception. Phosphenes appeared completely or partially in the left hemifield. Stimulation of the electrodes below the calcarine sulcus elicited phosphenes in the superior hemifield and vice versa. Changing the stimulation parameters of frequency, pulse width, and burst duration affected current thresholds for eliciting phosphenes, and increasing the amplitude or frequency of stimulation resulted in brighter perceptions. While stimulation thresholds decreased between an average of 5% and 12% after 19 months, spatial mapping of phosphenes remained consistent over time. Although no serious adverse events were observed, the subject experienced mild headaches and dizziness in three instances, symptoms that did not persist for more than a few hours and for which no clinical intervention was required.Using an off-the-shelf neurostimulator, the authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events, providing preliminary proof of feasibility and safety to proceed with visual epicortical prosthetic clinical trials. Moreover, they systematically explored the relationship between stimulation parameters and phosphene thresholds and discovered the direct relation of perception thresholds based on primary visual cortex (V1) neuronal population excitation thresholds.

Safety of Vinflunine in Patients with Advanced Urothelial Carcinoma Refractory to Platinum-based Chemotherapy: A Prospective Pilot Study

2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Transitional Cell ◽  
Chemotherapeutic Agents ◽  
Serious Adverse Events ◽  
Platinum Based Chemotherapy ◽  
Number Of Patients ◽  
Advanced Urothelial Carcinoma ◽  
Grade 3

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.

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