OBSERVATIONAL STUDY OF COSTS AND APPROPRIATENESS OF USE OF HEMOSTATIC DEVICES AND DRUGS IN DIFFERENT TYPES OF BLEEDING

Abstract

Introduction:
Bleedings can result from insufficient blood coagulation and represent a relevant clinical aspect in medical practice. In most cases, these are genetically determined disorders that persist throughout a person's life, leapractice. In most cases, these are genetically determined disorders that persist throughout a person's life, leading to a significant financial burden on the National Health System and affecting the patient's quality of life.
On the other hand, the bleeding phenomenon can be influenced in its potential complications by various factors such as pharmacological therapies, autoantibodies, clinical situations, lifestyle, and other factors related to possible genetic predispositions. These undesirable effects pose a diagnostic and therapeutic challenge that often presents characteristics of urgency and severity due to disruptions in the patient's hemostatic balance.
Pharmacological therapy with anticoagulants, whether they are heparin-based or NOACs, can affect the duration and quantity of bleeding. Therefore, it is essential to always inform the surgeon and the general practitioner before any procedure if the patient is on these medications. The replacement or discontinuation of these drugs should only be carried out under medical guidance, even if it's for preparing for minor or major surgical interventions. Stopping bleeding is an essential medical procedure, both in the operating room and in outpatient settings. The choice of hemostatic drug or device to use is based on the type of bleeding to be treated and can be a lifesaver for the patient, expediting the recovery process. Making the most appropriate choice promptly can lead to significant economic savings, making it an effective and efficient practice without wasteful decisions.

Materials and Methods:
The study is observational and multicentric, spanning over 36 months, with data collected from a cohort of 75,000 patients treated at the departments and clinics of the San Giuliano Hospital within the territory of ASL Napoli 2 Nord in the northern area of the Campania capital. The degree of bleeding from the lesions was classified based on a scale validated by the FDA, dividing the phenomenon into grades ranging from 0 to 4. Grade 0 refers to blood loss <1.0 mL/min, Grade 1 to bleeding between 1.0 < mL/min > 5.0, Grade 2 to bleeding between 5.0 < mL/min > 10.0, Grade 3 to bleeding between 10.0 < mL/min > 50.0, and Grade 4 to bleeding with blood loss > 50 mL/min. This division corresponds to a severity threshold and relative life-threatening risk based on the quantity of bleeding. Medical professionals who intervened or were responsible for follow-up visits were given a mini-questionnaire in which they were asked to classify the outcome success rate based on the percentage, assessing the cessation of bleeding considering the initial severity according to the FDA scale. The obtained responses were classified as perfect, good, sufficient, or failed based on the achieved outcome, also correlated with the type of hemostatic device and/or drug used for each individual treatment. The considered therapies involving hemostatic devices and/or drugs were evaluated for total cost. Responses that initially failed were subsequently reclassified as at least sufficient, in order to understand the economic impact of less consistent choices in the treated cases and the related financial expenditure. Within the costs assessed for therapies from sufficient to perfect, all costs related to cases where therapy needed to be modified to improve the outcome were already included.

Results:
During the 36 months of the study, the outcomes of the 75,000 cases were collected, and each of them was attributed to a grade on the FDA scale. Considering the outcomes, the observed responses were effective, with just under 7% of the total not reaching the levels from perfect to sufficient. The threshold for a failed outcome was intentionally set very high (positive outcome less than 49%) to maintain high performance levels to ensure a good average success rate of the therapies. It is worth noting that out of the 7% of failed responses, only 2% yielded a positive outcome of less than 22%, indicating a significant deviation from the average positivity standards achieved. The outcomes are influenced by the choices made during the bleeding treatment phase, particularly when considering the total for each group. This allowed for the identification of the best therapeutic choices for each grade on the FDA scale. Thus, adhesive sealants were classified as Perfect for Grade 0 cases with only Blood Loss, hemostatic patches for Grade 2, and surgical adjuvants with thrombin and coagulation factor for Grade 4 cases where the patient's life is seriously at risk. Hemostatic powders and dressings were classified as Sufficient for Grade 1 cases, while the hemostatic matrix performed well for Grade 3 cases.
When considering the percentage impact on the total cost of the individual observed responses, it was revealed that perfect responses account for 43%, while failed responses account for 10%. In conclusion, the average costs of treatments resulting in a failed response were approximately €135,000. The costs related to the change of therapy to improve the initially obtained response were also calculated.

Conclusions:
The appropriate classification of the type of bleeding allows for swift intervention and a higher accuracy in selecting the appropriate medical device and/or medication. By using the FDA-validated bleeding scale, optimal results for the patient's life can be achieved quickly, which is highly significant for their recovery.
Simultaneously, making the correct choice regarding the use of medication and/or devices to stop bleeding leads to continuous cost monitoring for the corresponding therapies, achieving efficiency and effectiveness while containing costs. The total costs of the 75,000 observed therapies conducted over 36 months in the departments, including the Emergency Room and outpatient clinics of San Giuliano Hospital to address hemorrhages, amounted to approximately €1,500,000. Out of this, around €150,000 could have been saved with a targeted and appropriate choice of the most suitable therapy.