RESUMO
OBJECTIVE: To present an alternative cost-effective hemostatic agent (HA) for cranial surgery and to describe the technique to produce it. METHODS: This HA has been used in 3 reference centers over the last year during 230 procedures, including different types of pathology, such as skull base, oncology, vascular, and trauma, either for endoscopic or open approaches. This agent was made from a low-cost and worldwide-available gelatin foam which was mixed with saline solution in 2 syringes and connected by a 3-way stopcock, making a useful hemostatic paste. RESULTS: The cost was 16 and 28 times less than SURGIFLO and FLOSEAL, respectively. The mean time to prepare the mix was 4 minutes. It was very effective for venous and low-flow bleeding. CONCLUSIONS: The presented technique offers a reliable and cost-effective way of achieving hemostasis in cranial surgery, therefore allowing hospitals with limited resources to perform advanced procedures in a safer way.
Assuntos
Gelatina/economia , Gelatina/uso terapêutico , Hemostáticos/economia , Hemostáticos/uso terapêutico , Procedimentos Neurocirúrgicos/economia , Perda Sanguínea Cirúrgica/prevenção & controle , Análise Custo-Benefício , Esponja de Gelatina Absorvível/economia , Técnicas Hemostáticas/economia , Técnicas Hemostáticas/instrumentação , Humanos , Procedimentos Neurocirúrgicos/métodos , Crânio/cirurgia , Trombina/economia , Fatores de TempoRESUMO
BACKGROUND: A five-year retrospective database analysis comparing the use of Floseal 1 flowable topical hemostat alone (F) and in combination with gelatin/thrombin (F + G/T) to achieve hemostasis and control surgical bleeding showed higher resource utilization for F + G/T cases relative to F matched pairs during spinal surgery. Lower resource use in the F group was characterized by shorter hospital length of stay and surgical time as well as fewer blood transfusions and less hemostat agent used per surgery. OBJECTIVE: To evaluate the cost-consequence of using F compared to F + G/T in minor, major and severe spinal surgery from the US hospital perspective. METHODS: A cost-consequence model was developed using the US hospital perspective. Model inputs include clinical inputs from the literature, cost inputs (hemostatic matrices, blood product transfusion, hospital stay and operating room time) from the literature, and an analysis of annual spine surgery volume (minor, major and severe) using the 2012 National Inpatient Sample (NIS) database. Costs are reported in 2017 US dollars. One-way and probabilistic sensitivity analyses address sources of variability in the results. RESULTS: A medium-volume hospital (130 spine surgeries per year) using F versus F + G/T for spine surgeries is expected to require 85 less hours of surgical time, 58 fewer hospital days and 7 fewer blood transfusions in addition to hemostat volume savings (F: 1 mL, thrombin: 1994 mL). The cost savings associated with the hospital resources for a medium-volume hospital are expected to be $317,959 (surgical hours = $154,746, hospital days = $125,237, blood transfusions = $19,023, hemostatic agents = $18,953) or $2445 per spine surgery. CONCLUSIONS: The use of F versus F + G/T could lead to annual cost savings for US hospitals performing a low to high volume of spinal surgeries per year.
Assuntos
Esponja de Gelatina Absorvível/economia , Esponja de Gelatina Absorvível/uso terapêutico , Hemostáticos/economia , Hemostáticos/uso terapêutico , Procedimentos Neurocirúrgicos/métodos , Perda Sanguínea Cirúrgica/prevenção & controle , Transfusão de Sangue/estatística & dados numéricos , Análise Custo-Benefício , Quimioterapia Combinada , Gelatina/economia , Gelatina/uso terapêutico , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Tempo de Internação , Duração da Cirurgia , Estudos Retrospectivos , Trombina/economia , Trombina/uso terapêuticoRESUMO
BACKGROUND: Several studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer. METHODS: In a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil® patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage. RESULTS: Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil® and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512-895 ml]. Application of TachoSil® did not significantly reduce the total volume of axillary drainage [mean difference (MD) -110 ml, 95% CI -316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil®. The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625-35,880) with TachoSil® and 33,365 Swiss Francs (95% CI 31,771-34,961) without, p = 0.584]. In the TachoSil® group, length of stay was longer (MD 1 day, 95% CI 0.3-1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1-4) vs. 5.5 days (95% CI 2-11); p = 0.2]. CONCLUSIONS: TachoSil® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.
Assuntos
Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Drenagem , Fibrinogênio/uso terapêutico , Excisão de Linfonodo , Trombina/uso terapêutico , Técnicas de Fechamento de Ferimentos/instrumentação , Idoso , Axila , Combinação de Medicamentos , Feminino , Fibrinogênio/economia , Custos de Cuidados de Saúde , Humanos , Tempo de Internação , Excisão de Linfonodo/efeitos adversos , Excisão de Linfonodo/economia , Mastectomia Segmentar , Pessoa de Meia-Idade , Dor Pós-Operatória/etiologia , Trombina/economia , Técnicas de Fechamento de Ferimentos/economiaRESUMO
Haemostasis is of fundamental significance in neurosurgery, and insufficient control of bleeding is associated with morbidity and mortality. Topical haemostatic agents play an important role, as the characteristics of neuronal tissue limit the use of classical surgical haemostasis techniques. Appropriate choice of agent depends on the location and type of bleeding, but also on knowledge of the products' mechanisms of action, indications, price and accessibility. Biological products are superior to the mechanical in efficacy but require more preparation and are significantly more cost-intensive.
Assuntos
Hemostasia , Hemostáticos , Procedimentos Neurocirúrgicos/métodos , Perda Sanguínea Cirúrgica/prevenção & controle , Celulose Oxidada/administração & dosagem , Celulose Oxidada/economia , Celulose Oxidada/uso terapêutico , Colágeno/administração & dosagem , Colágeno/economia , Colágeno/uso terapêutico , Fibrina/administração & dosagem , Fibrina/economia , Fibrina/uso terapêutico , Hemostasia/efeitos dos fármacos , Hemostasia/fisiologia , Hemostáticos/administração & dosagem , Hemostáticos/economia , Hemostáticos/farmacocinética , Hemostáticos/uso terapêutico , Humanos , Peróxido de Hidrogênio/administração & dosagem , Peróxido de Hidrogênio/economia , Peróxido de Hidrogênio/uso terapêutico , Procedimentos Neurocirúrgicos/economia , Palmitatos/administração & dosagem , Palmitatos/economia , Palmitatos/uso terapêutico , Cloreto de Sódio/administração & dosagem , Cloreto de Sódio/economia , Cloreto de Sódio/uso terapêutico , Tampões de Gaze Cirúrgicos/economia , Trombina/administração & dosagem , Trombina/economia , Trombina/uso terapêutico , Ceras/economia , Ceras/uso terapêuticoRESUMO
INTRODUCTION: SURGIFLO and FLOSEAL are absorbable gelatin-based products that form hemostatic matrices. These products are indicated as adjuncts to hemostasis when control of bleeding by conventional surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. This study analyzed the effect of surgery time and the choice of product on cost to the hospital and patient outcomes. METHODS: The data source was the Premier Hospital database from January 1, 2010-June 30, 2012. Eligible patients were ≥18 years of age with a spinal fusion or refusion surgery with either SURGIFLO (Ethicon Inc.) or FLOSEAL (Baxter International Inc.). The hospital Charge Master was used to identify the amount of flowable product, whether it included Thrombin, and the cost. Multivariable models were performed on overall cost and likelihood of surgical complications. All models were adjusted for patient demographics and severity as well as hospital, and surgical characteristics. RESULTS: A total of 24,882 patient records from 121 hospitals were analysed, which included 15,088 FLOSEAL records and 9794 SURGIFLO records, with 1498 SURGIFLO with Thrombin patients. Little or no differences in surgical complications were found between surgeries with SURGIFLO vs. surgery with FLOSEAL. Regression models showed a reduction in cost of $65 associated with use of SURGIFLO with Thrombin and an additional $21 reduction in hospital cost for each additional hour of surgery. Modeling which accounts for hospital fixed effects suggest that, in addition to a gap of â¼$300 favoring SURGIFLO with Thrombin, every additional hour of surgery was associated with an additional reduction in hospital costs of â¼$26. CONCLUSIONS: While the choice of flowable product had no effect on clinical outcomes, use of SURGIFLO was associated with hospital cost savings for flowable product. These savings increased with the length of surgery, even when controlling for the amount of flowable product (mL) used.
Assuntos
Esponja de Gelatina Absorvível/economia , Hemostáticos/economia , Custos Hospitalares/estatística & dados numéricos , Trombina/economia , Adulto , Idoso , Feminino , Esponja de Gelatina Absorvível/uso terapêutico , Hemostáticos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Análise de Regressão , Fusão Vertebral , Dispositivos de Fixação Cirúrgica , Trombina/uso terapêuticoRESUMO
BACKGROUND: TachoSil(®) is a medicated sponge coated with human fibrinogen and human thrombin. It is indicated as a support treatment in adult surgery to improve hemostasis, promote tissue sealing, and support sutures when standard surgical techniques are insufficient. This review systematically analyses the international scientific literature relating to the use of TachoSil in hemostasis and as a surgical sealant, from the point of view of its economic impact. METHODS: We carried out a systematic review of the PubMed literature up to November 2013. Based on the selection criteria, papers were grouped according to the following outcomes: reduction of time to hemostasis; decrease in length of hospital stay; and decrease in postoperative complications. RESULTS: Twenty-four scientific papers were screened, 13 (54%) of which were randomized controlled trials and included a total of 2,116 patients, 1,055 of whom were treated with TachoSil. In the clinical studies carried out in patients undergoing hepatic, cardiac, or renal surgery, the time to hemostasis obtained with TachoSil was lower (1-4 minutes) than the time measured with other techniques and hemostatic drugs, with statistically significant differences. Moreover, in 13 of 15 studies, TachoSil showed a statistically significant reduction in postoperative complications in comparison with the standard surgical procedure. The range of the observed decrease in the length of hospital stay for TachoSil patients was 2.01-3.58 days versus standard techniques, with a statistically significant difference in favor of TachoSil in eight of 15 studies. CONCLUSION: This analysis shows that TachoSil has a role as a supportive treatment in surgery to improve hemostasis and promote tissue sealing when standard techniques are insufficient, with a consequent decrease in postoperative complications and hospital costs.
Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Custos de Medicamentos , Fibrinogênio/economia , Fibrinogênio/uso terapêutico , Técnicas Hemostáticas/economia , Hemostáticos/economia , Hemostáticos/uso terapêutico , Avaliação de Processos e Resultados em Cuidados de Saúde/economia , Trombina/economia , Trombina/uso terapêutico , Análise Custo-Benefício , Combinação de Medicamentos , Fibrinogênio/efeitos adversos , Técnicas Hemostáticas/efeitos adversos , Custos Hospitalares , Humanos , Tempo de Internação/economia , Hemorragia Pós-Operatória/economia , Hemorragia Pós-Operatória/prevenção & controle , Trombina/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
AIM: The aim of this study was to evaluate the efficacy and cost-effectiveness of fibrinogen/thrombin-coated collagen patch (FTCCP)(TachoSil®) during intraoperative hemostasis in patients with congenital heart disease, who required a reoperation during childhood. METHODS: We reviewed data on the intraoperative blood product requirements and hospital costs of children (age <16 years) who underwent a reoperation for treating their congenital heart disease between January 2009 and December 2011. RESULTS: One-hundred and seventeen patients were included. Median age at surgery was 2.1 years (range 3 days-14.1 years). Main causes of intraoperative bleeding were: 1) reinforcement of suture lines (106 patients, 90.6%); 2) lung lesions (5 patients, 4.2%); 3) epicardial lesions (3 patients, 2.6%); and 4) chest wall lesions (3 patients, 2.6%). At logistic regression the amount of packed red blood cells (PRBC) requirement was significantly higher in patients with preoperative cyanosis (P=0.008, OR=3.85) and in patients who required the use of cardiopulmonary bypass (P=0.005, OR=21.19). The use of FTCCP (N.=90 patients) as first line treatment was significantly associated with a lower PRBC requirement (P=0.0003, OR=0.1) which in addition to the avoidance of other hemostatic/sealant agents, leads to lower hospital cost. CONCLUSION: FTCCP is an effective hemostatic agent which can be safely used during the hemostasis of children requiring reoperations for their congenital heart malformations. When used as first line treatment, with specific indications, FTCCP limited the intraoperative PRBC requirement and the use of other hemostatic/sealant agents thus reducing hospital costs.
Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos , Fibrinogênio/uso terapêutico , Cardiopatias Congênitas/cirurgia , Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Trombina/uso terapêutico , Adolescente , Fatores Etários , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/economia , Criança , Pré-Escolar , Redução de Custos , Análise Custo-Benefício , Combinação de Medicamentos , Custos de Medicamentos , Transfusão de Eritrócitos , Feminino , Fibrinogênio/efeitos adversos , Fibrinogênio/economia , Cardiopatias Congênitas/economia , Hemostasia Cirúrgica/efeitos adversos , Hemostasia Cirúrgica/economia , Hemostáticos/efeitos adversos , Hemostáticos/economia , Humanos , Lactente , Recém-Nascido , Itália , Modelos Logísticos , Masculino , Razão de Chances , Transfusão de Plaquetas , Reoperação , Estudos Retrospectivos , Fatores de Risco , Trombina/efeitos adversos , Trombina/economia , Fatores de Tempo , Resultado do TratamentoRESUMO
Thrombin has demonstrated utility in aiding surgical hemostasis since its introduction more than 60 years ago. It is used across a wide variety of surgical procedures by virtually every specialty. Only recently have new equally effective and safe products entered the market, causing decision makers to evaluate formulary selection among products with otherwise modest differences. This evaluation includes identifying costs beyond those of acquisition and storage, as well as indirect factors such as monitoring or specialized distribution requirements. One factor to consider specifically in selection of topical thrombin products is the potential for patients to develop an immune-mediated coagulopathy (IMC) after exposure to bovine-derived thrombin. Costs due to adverse drug events fall into the category of indirect costs and, in some instances, can be substantial if bleeding due to IMC occurs.
Assuntos
Transtornos da Coagulação Sanguínea/economia , Hemostáticos/economia , Trombina/economia , Administração Tópica , Animais , Transtornos da Coagulação Sanguínea/induzido quimicamente , Transtornos da Coagulação Sanguínea/imunologia , Bovinos , Custos de Medicamentos , Formulários de Hospitais como Assunto , Hemostasia Cirúrgica/economia , Hemostasia Cirúrgica/métodos , Hemostáticos/efeitos adversos , Hemostáticos/uso terapêutico , Humanos , Hemorragia Pós-Operatória/prevenção & controle , Trombina/efeitos adversos , Trombina/uso terapêuticoRESUMO
Patients with severe haemophilia A and an inhibitor may become refractory to FEIBA and/or recombinant factor VIIa (rFVIIa). Sequential therapy with both products has been reported in such patients. In this pilot study, we examined the safety and efficacy of combined rFVIIa and FEIBA therapy in patients with haemophilia A and inhibitors during bleeding episodes. We also tried to evaluate whether thrombin generation (TG), by various mixtures of these agents, can serve as a guide for tailoring therapy. TG was measured in plasma taken from eight haemophilia A patients. Increasing concentrations of rFVIIa, FEIBA or both were added ex vivo to the plasmas, and TG was induced by recalcification. Since low concentrations of rFVIIa and FEIBA had either an additive or a synergistic effect in all patients, the lowest combination, yielding TG comparable or lower than TG achieved with either FEIBA 100 U kg(-1) or rFVIIa 160 microg kg(-1) alone, was selected for the treatment of bleeding episodes. Five patients with a high titre of an inhibitor (8-1300 BU), including one previously refractory to infusions of rFVIIa at doses up to 400 microg kg(-1) X4 daily, were treated with combinations of 30-70 microg kg(-1) rFVIIa and 20-30 U kg(-1) FEIBA during a total number of 400 bleeding episodes with excellent haemostatic effect. No adverse events and no DIC were observed following these infusions. Concomitant infusion of low-dose rFVIIa and low-dose FEIBA, seems to be safe, efficacious and economical in patients refractory to rFVIIa and probably other haemophilia A patients with an inhibitor.
Assuntos
Fatores de Coagulação Sanguínea/administração & dosagem , Fator VIIa/administração & dosagem , Hemartrose/tratamento farmacológico , Hemofilia A/tratamento farmacológico , Trombina/administração & dosagem , Adolescente , Adulto , Inibidores dos Fatores de Coagulação Sanguínea/administração & dosagem , Inibidores dos Fatores de Coagulação Sanguínea/economia , Fatores de Coagulação Sanguínea/economia , Análise Custo-Benefício , Relação Dose-Resposta a Droga , Esquema de Medicação , Quimioterapia Combinada , Fator VIIa/economia , Hemartrose/economia , Hemofilia A/economia , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/economia , Trombina/economia , Adulto JovemRESUMO
BACKGROUND: Topical thrombins are active hemostatic agents that can be used to minimize blood loss during surgery. Before 2007, the only topical thrombins available were derived from bovine plasma. Antibody formation to bovine thrombin and/or factor V, with subsequent risk of cross-reactivity with human factor V, and hemorrhagic complications associated with human factor-V deficiencies have been described in case reports of surgeries in which bovine thrombins were used. This risk is now included in the boxed warning section of the bovine thrombin prescribing information. In 2007 and 2008, 2 new topical thrombins from nonbovine sources received approval for use from the US Food and Drug Administration. The 3 active topical thrombins that are currently marketed are bovine plasma-derived thrombin, human plasma-derived thrombin, and human recombinant thrombin. OBJECTIVE: The purpose of this review was to evaluate the literature on the efficacy and safety of topical thrombins and discuss the pharmacoeconomic considerations associated with their use. METHODS: PubMed, EMBASE, and International Pharmaceutical Abstracts were searched for relevant papers published in English through October 10,2008, using the terms thrombin, human recombinant thrombin, bovine thrombin, plasma derived thrombin, and topical thrombin. Manufacturer-provided materials were also reviewed. Abstracts and unpublished data, as well as evaluations of sealants, adhesives, glues, and other hemostats that contain thrombin mixed with fibrinogen and other clotting factors, were excluded. RESULTS: Four randomized, double-blind studies involving the active, stand-alone topical thrombins were found. The bovine thrombin involved in these studies was the predecessor to the currently marketed, highly purified bovine formulation. No studies comparing the human products, studies involving the highly purified bovine preparation, or placebo-controlled studies involving bovine thrombin were found. In a Phase III comparison of human recombinant thrombin and bovine thrombin, the percentages of patients who achieved hemostasis within 10 minutes of topical thrombin application were 95.4% and 95.1%, respectively (95% CI, -3.7 to 5.0). The incidence of hemostasis within 10 minutes was also similar in a Phase III comparison of human plasma-derived thrombin and bovine thrombin (both, 97.4% [95% CI, 0.96 to 1.05]). In the study that compared human recombinant and bovine thrombin, the incidence of antiproduct antibody formation was 21.5% (43/200) in the bovine thrombin group and 1.5% (3/198) in the human recombinant thrombin group (P < 0.001); patients with antibodies to bovine thrombin had numerically higher incidences of bleeding or thromboembolic events than did patients without these antibodies (19% vs 13%; P value not reported). Human plasma-derived thrombin is available as a frozen sterile solution that must be thawed before application, whereas the human recombinant and bovine plasma-derived products are supplied as unrefrigerated sterile powders that must be reconstituted before use. The human thrombins are more costly than bovine thrombin on a per-vial basis. The average wholesale prices (US $, 2008) for 5000-IU vials of bovine thrombin and human recombinant thrombin were $87.85 and $103.20, respectively; the average wholesale price for a 4000- to 6000-IU vial of human plasma-derived thrombin was $96.00. CONCLUSIONS: Topical thrombins vary in the ways in which they are manufactured and their safety profiles, storage requirements, and costs. Human recombinant thrombin and human plasma-derived thrombin have each been shown to have hemostatic efficacy comparable to that of bovine thrombin. Bovine thrombin carries the risk of formation of cross-reactive antibodies to bovine thrombin, factor V, and other impurities that may be present in these formulations. Immunogenicity data for the currently marketed, highly purified bovine thrombin relative to older formulations of bovine thrombin could not be found. Whether the potential safety advantage justifies the added cost of the human products remains to be established.
Assuntos
Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Trombina/uso terapêutico , Administração Tópica , Animais , Bovinos , Custos de Medicamentos , Hemostáticos/efeitos adversos , Hemostáticos/economia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/economia , Trombina/efeitos adversos , Trombina/economia , Estados UnidosAssuntos
Aprotinina/economia , Fibrinogênio/economia , Administração Financeira de Hospitais , Serviços de Saúde/economia , Hemostáticos/economia , Procedimentos Cirúrgicos Operatórios/economia , Trombina/economia , Cavidade Abdominal/cirurgia , Aprotinina/uso terapêutico , Análise Custo-Benefício , Combinação de Medicamentos , Farmacoeconomia , Fibrinogênio/uso terapêutico , Hemostasia Cirúrgica/economia , Hemostáticos/uso terapêutico , Custos Hospitalares , Humanos , Federação Russa , Trombina/uso terapêuticoRESUMO
OBJECTIVES: To compare the cost of materials and hospitalization for standard techniques (suturing, stapling and electrocautery) for sealing the lung after pulmonary resection with those for a fleece-bound sealing procedure. METHODS: This cost comparison analysis uses as its basis a prospective randomised clinical trial involving 152 patients with pulmonary lobectomy/segmentectomy (standard technique group: 77 patients; fleece-bound sealing group: 75 patients). The cost comparison was performed from the economic perspective of Austrian and German hospitals, taking into consideration the cost of materials for the two alternatives as well as the mean time to hospital discharge. RESULTS: The clinical study found significantly smaller postoperative air leaks in the fleece-bound sealing group. The mean times to chest drain removal and to hospital discharge were also significantly reduced after application of fleece-bound sealing [5.1 vs. 6.3 days (P=0.022) and 6.2 vs. 7.7 days (P=0.01), respectively]. The cost of materials for sealing air leaks amounted to euro47 per patient in the standard technique group and euro410 per patient in the fleece-bound sealing group. The 1.5-day reduction in the length of hospital stay associated with fleece-bound sealing represents a saving of euro462 per patient. CONCLUSIONS: There was an overall saving of euro99 for the fleece-bound sealing procedure compared to standard techniques for sealing the lung following pulmonary resection.