budget impact analysis of a biosynthetic mesh for incisional hernia repair

Abstract Purpose With the development of newer prostheses for hernia repair, it is nowadays difficult to understand the total cost of managing patients treated with these advanced medical devices, especially in the complex abdomen, in which various complications may occur. The aim of this study was to determine the economic implications of these prostheses in order to inform decision making in the management of incisional hernia repair. Methods A budget impact analysis model was developed to evaluate the economic consequences related to the management of patients undergoing complex (Centers for Disease Control and Prevention wound class II–III or Ventral Hernia Working Group grade 2/3) incisional hernia repair through biosynthetic, synthetic, or biological meshes, from the hospital perspective in Italy. The model was populated with complication rates mainly retrieved from the literature to compare the current scenario with 60%, 10%, and 30% rates of synthetic, biosynthetic, and biological mesh utilization, respectively, with future hypothetical scenarios that consider increasing rates of biosynthetic mesh utilization with respect to the other types of mesh in the next 5 years. Hospital costs of the different events were estimated based on health care resource consumption derived from an electronic survey addressed to key opinion leaders in the field. Findings The analysis compared the current scenario with future hypothetical scenarios that consider increasing utilization rates of biosynthetic meshes of 25%, 38%, and 44% in the next 1, 3, and 5 years, as estimated by clinicians. Considering 40,000 incisional hernia repairs per year, an increasing use of the biosynthetic meshes may result in a decrease in the total hospital budget of about €153 million in the next 5 years, with a savings per patient of about €770. Implications The findings of this study support the use of biosynthetic meshes for complex abdominal wall repairs in Italy, showing a potential decrease in the hospital budget in Italy after the diffusion of the new biosynthetic prostheses. Further studies and data from clinical practice would provide additional information to increase the understanding of the economic sustainability of these advanced devices

TREATMENT WITH GROWTH HORMONE RECEPTOR ANTAGONIST IN ACROMEGALY: EFFECT ON CARDIAC ARRHYTHMIAS.

OBJECTIVE: to evaluate the effects of short and long-term treatment with pegvisomant (PEG) on arrhythmias in acromegalic patients resistant to long-term high-dose therapy with somatostatin analogues (SA). PATIENTS AND METHODS: thirteen patients entered the study. All patients started PEG at initial dose of 10 mg daily, then titrated of 5 mg every 6 weeks on the basis of IGF-I. A standard 24-h ECG registration was performed in all patients at baseline and after 6 and 18 months of PEG to evaluate: mean (HR), maximum (MHR) and minimum (mHR) heart rate, pauses number (P) and duration (PD), supraventricular episodes number (SE) and duration (SED), ventricular ectopic beats number (EB) and duration (EBD). Left ventricular mass (LVM) was also evaluated by standard echocardiography RESULTS: A slight but not significant decrease in HR, MHR and mHR was observed after 6-month PEG, whereas a significant decrease in HR (p=0.03), MHR (p=0.05) and mHR (p=0.05) was found after 18-month PEG compared to baseline. LVM significantly (p=0.05) correlated with MRH (r= -0.50) after short-term treatment, and with HR (r= -0.54) and mHR (r= -0.55) after long-term treatment. Long-term PEG induced the complete recover of arrhythmias recorded at baseline in one patient and the improvement of rhythm disorders developed after 6-month therapy in another patient. The prevalence of conduction disturbances passed from 15% to 7.7% after long-term PEG. CONCLUSIONS: Long-term treatment with PEG reduces HR, MHR and mHR and improves rhythm abnormalities in acromegal

Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Use for Atherogenic Dyslipidemia in Solid Organ Transplant Patients

Dyslipidemia is a widespread risk factor in solid organ transplant patients, due to many reasons, such as the use of immunosuppressive drugs, with a consequent increase in cardiovascular diseases in this population. PCSK9 is an enzyme mainly known for its role in altering LDL levels, consequently increasing cardiovascular risk. Monoclonal antibody PCSK9 inhibitors demonstrated remarkable efficacy in the general population in reducing LDL cholesterol levels and preventing cardiovascular disease. In transplant patients, these drugs are still poorly used, despite having comparable efficacy to the general population and giving fewer drug interactions with immunosuppressants. Furthermore, there is enough evidence that PCSK9 also plays a role in other pathways, such as inflammation, which is particularly dangerous for graft survival. In this review, the current evidence on the function of PCSK9 and the use of its inhibitors will be discussed, particularly in transplant patients, in which they may provide additional benefits

Relationship between low Ankle-Brachial Index and rapid renal function decline in patients with atrial fibrillation: a prospective multicentre cohort study

OBJECTIVE: To investigate the relationship between Ankle-Brachial Index (ABI) and renal function progression in patients with atrial fibrillation (AF). DESIGN: Observational prospective multicentre cohort study. SETTING: Atherothrombosis Center of I Clinica Medica of 'Sapienza' University of Rome; Department of Medical and Surgical Sciences of University Magna Græcia of Catanzaro; Atrial Fibrillation Registry for Ankle-Brachial Index Prevalence Assessment-Collaborative Italian Study. PARTICIPANTS: 897 AF patients on treatment with vitamin K antagonists. MAIN OUTCOME MEASURES: The relationship between basal ABI and renal function progression, assessed by the estimated Glomerular Filtration Rate (eGFR) calculated with the CKD-EPI formula at baseline and after 2 years of follow-up. The rapid decline in eGFR, defined as a decline in eGFR >5 mL/min/1.73 m(2)/year, and incident eGFR<60 mL/min/1.73 m(2) were primary and secondary end points, respectively. RESULTS: Mean age was 71.8±9.0 years and 41.8% were women. Low ABI (ie, ≤0.90) was present in 194 (21.6%) patients. Baseline median eGFR was 72.7 mL/min/1.73 m(2), and 28.7% patients had an eGFR<60 mL/min/1.73 m(2). Annual decline of eGFR was -2.0 (IQR -7.4/-0.4) mL/min/1.73 m(2)/year, and 32.4% patients had a rapid decline in eGFR. Multivariable logistic regression analysis showed that ABI ≤0.90 (OR 1.516 (95% CI 1.075 to 2.139), p=0.018) and arterial hypertension (OR 1.830 95% CI 1.113 to 3.009, p=0.017) predicted a rapid eGFR decline, with an inverse association for angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (OR 0.662 95% CI 0.464 to 0.944, p=0.023). Among the 639 patients with AF with eGFR >60 mL/min/1.73 m(2), 153 (23.9%) had a reduction of the eGFR <60 mL/min/1.73 m(2). ABI ≤0.90 was also an independent predictor for incident eGFR<60 mL/min/1.73 m(2) (HR 1.851, 95% CI 1.205 to 2.845, p=0.005). CONCLUSIONS: In patients with AF, an ABI ≤0.90 is independently associated with a rapid decline in renal function and incident eGFR<60 mL/min/1.73 m(2). ABI measurement may help identify patients with AF at risk of renal function deterioration

Frequency of Left Ventricular Hypertrophy in Non-Valvular Atrial Fibrillation

Left ventricular hypertrophy (LVH) is significantly related to adverse clinical outcomes in patients at high risk of cardiovascular events. In patients with atrial fibrillation (AF), data on LVH, that is, prevalence and determinants, are inconsistent mainly because of different definitions and heterogeneity of study populations. We determined echocardiographic-based LVH prevalence and clinical factors independently associated with its development in a prospective cohort of patients with non-valvular (NV) AF. From the "Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study" (ARAPACIS) population, 1,184 patients with NVAF (mean age 72 \ub1 11 years; 56% men) with complete data to define LVH were selected. ARAPACIS is a multicenter, observational, prospective, longitudinal on-going study designed to estimate prevalence of peripheral artery disease in patients with NVAF. We found a high prevalence of LVH (52%) in patients with NVAF. Compared to those without LVH, patients with AF with LVH were older and had a higher prevalence of hypertension, diabetes, and previous myocardial infarction (MI). A higher prevalence of ankle-brachial index 640.90 was seen in patients with LVH (22 vs 17%, p = 0.0392). Patients with LVH were at significantly higher thromboembolic risk, with CHA2DS2-VASc 652 seen in 93% of LVH and in 73% of patients without LVH (p <0.05). Women with LVH had a higher prevalence of concentric hypertrophy than men (46% vs 29%, p = 0.0003). Logistic regression analysis demonstrated that female gender (odds ratio [OR] 2.80, p <0.0001), age (OR 1.03 per year, p <0.001), hypertension (OR 2.30, p <0.001), diabetes (OR 1.62, p = 0.004), and previous MI (OR 1.96, p = 0.001) were independently associated with LVH. In conclusion, patients with NVAF have a high prevalence of LVH, which is related to female gender, older age, hypertension, and previous MI. These patients are at high thromboembolic risk and deserve a holistic approach to cardiovascular prevention

Correction to: Major adverse cardiovascular events in non-valvular atrial fibrillation with chronic obstructive pulmonary disease: the ARAPACIS study (Internal and Emergency Medicine, (2018), 13, 5, (651-660), 10.1007/s11739-018-1835-9)

In the original publication, one of the ARAPACIS collaborators Dr. “Leonardo Di Gennaro” name has been erroneously mentioned as “Leonardo De Gennaro”