New oral anti-coagulants versus vitamin K antagonists in high thromboembolic risk patients.

BACKGROUND: Oral anticoagulant therapy (VKA) is nowadays the mainstay of treatment in primary and secondary stroke prevention in patients with atrial fibrillation. Given the limited risk-benefit ratio of vitamin K antagonists, pharmacological research has been directed towards the development of products that could overcome these limits, new oral anticoagulants were recently introduced: dabigatran, rivaroxaban, apixaban, and edoxaban. AIM: Scope of the present study was to examine patterns of use, effectiveness, safety and mean annual cost per patient of anticoagulant treatment for non-valvular AF in real clinical practice. METHODS: A retrospective observational cohort study, by using administrative databases (drugs, hospitalizations, clinical visits, lab tests, population registry), was conducted in the Local Health Unit (LHU) of Treviso, Italy, from January 1, 2012 to December 31, 2016. RESULTS: 5597 subjects were selected, 2171 of which satisfied all inclusion criteria. In particular 1355 patients were treated with VKA, 577 patients were treated with NOAC, and 239 patients were treated initially with VKA and subsequently switched to NOAC (switch group). NOAC treatment showed to be superior to VKA and this superiority was statistically significant on both end-points: patients in the NOAC group reported less cardiovascular events (9,9%) and less bleeding episodes (5,5%) versus VKA patients (14,6% and 11,4%; p<,0001 and p = 0,0049, respectively). The mean cost per patient per year was respectively € 1323,9 for patients treated with NOAC versus € 1003,3 for patients treated with VKA. Cost difference appears to be largely driven by drug cost (€ 767,9 for NOAC versus € 17,7 for VKA patients) and by specialist visits and laboratory tests (€ 318,4 for NOAC versus € 733,4 for VKA patients). CONCLUSION: In this retrospective real-world study treatment with NOAC showed to be associated with significant reductions of CV events and bleeding events compared to VKA use, albeit at a higher NHS' direct cost per patient/year, mainly due to higher drug therapy cost.

Cost-Effectiveness of Dabigatran Exilate in Treatment of Atrial Fibrillation.

BACKGROUND: Dabigatran exilate has emerged as a highly effective tool in treating atrial fibrillation, AF). Its relative convenience in terms of cost and overall utility with respect to other anti-coagulants, however, has not been explored in much detail yet. METHODS AND RESULTS: We run a Markovian disease simulation model based on a cohort of 1000 randomly generated patients which were sub-grouped by average risk of hemorrhage and average risk of stroke to compare treatments with Aspirin, Warfarin and Dabigatran. Quality-adjusted life-year, QALYs) for the patients were projected over up to 30 years with mortality statistics database and properly adjusted after every 5-year survival from the starting date. If managed within the prescribed range, Warfarin offers the highest outcome in terms of QALYs: 7.93 versus 7.61 for the Aspirin treatment and 7.57 for highest dose treatment with Dabigatran. Dabigatran outperformed the other treatments in patients at high risk of major stroke, provided Warfarin was not managed optimally. The incremental cost-effectiveness ratio for Dabigatran versus sub-optimally managed Warfarin was €7,759.48/QALY meaning that every year in perfect health earned with Dabigatran cost less than €8,000 more than the alternative treatment with Warfarin. CONCLUSIONS: The therapy with high-dose Dabigatran proved the most clinically safe solution for patients at high risk of stroke unless Warfarin therapy was excellent.

[Catheter ablation of atrial fibrillation: Health Technology Assessment Report from the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)]. / Ablazione transcatetere della fibrillazione atriale. Health Technology Assessment Report dell'Associazione Italiana di Aritmologia e Cardiostimolazione (AIAC).

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and significantly impact patients' quality of life, morbidity and mortality. The number of affected patients is expected to increase as well as the costs associated with AF management, mainly driven by hospitalizations. Over the last decade, catheter ablation techniques targeting pulmonary vein isolation have demonstrated to be effective in treating AF and preventing AF recurrence. This Health Technology Assessment report of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) aims to define the current role of catheter ablation of AF in terms of effectiveness, efficiency and appropriateness. On the basis of an extensive review of the available literature, this report provides (i) an overview of the epidemiology, clinical impact and socio-economic burden of AF; (ii) an evaluation of therapeutic options other than catheter ablation of AF; and (iii) a detailed presentation of clinical outcomes and cost-benefit ratio associated with catheter ablation. The costs of catheter ablation of AF in Italy were obtained using a bottom-up analysis of a resource utilization survey of 52 hospitals that were considered a representative sample, including 4 Centers that contributed with additional unit cost information in a separate questionnaire. An analysis of budget impact was also performed to evaluate the impact of ablation on the management costs of AF. Results of this analysis show that (1) catheter ablation is effective, safe and superior to antiarrhythmic drug therapy in maintaining sinus rhythm; (2) the cost of an ablation procedure in Italy typically ranges from €8868 to €9455, though current reimbursement remains insufficient, covering only about 60% of the costs; (3) the costs of follow-up are modest (about 8% of total costs); (4) assuming an adjustment of reimbursement to the real cost of an ablation procedure and a 5-10% increase in the annual rate of ablation procedures, after approximately 5-6 years this would result in significant incremental savings for the Italian Healthcare System. In conclusion, catheter ablation of AF is a cost-effective procedure that is inadequately reimbursed in Italy. Insufficient reimbursement may serve as disincentive to perform AF ablation, thereby limiting patient access to this treatment. Considering the healthcare system perspective, higher initial costs for ablation procedures in the short term may be offset by cost savings mainly associated with decreased hospitalizations over time.

Endoscopic fiberoptic assessment of balloon occlusion of the pulmonary vein ostium in humans: comparison with phased-array intracardiac echocardiography.

BACKGROUND: Anatomic pulmonary vein (PV) variants may affect the ability to position balloon catheter systems at the left atrium (LA)-PV junction with complete circumferential contact, resulting in ineffective PV isolation. OBJECTIVES: This feasibility study was performed to assess the use of the fiberoptic endoscopic light ring balloon catheter (ELRBC) in accessing the PVs and achieving adequate contact at the LA-PV junction, as visualized by phased-array intracardiac echocardiography (ICE). METHODS: We enrolled five men (mean age 59 +/- 8 years) with drug-refractory atrial fibrillation. The ELRBC consisted of a 25-mm balloon catheter with an integral endoscope contained within the balloon and a custom deflectable sheath. At the end of conventional PV isolation, the ELRBC was inserted into the LA in an attempt to position the balloon at each PV ostium. The real position of the ELRBC at this level was assessed by ICE in all patients. RESULTS: All but two PVs (right inferior PVs) (89%) were accessed with the ELRBC in a mean time of 17 +/- 3 minutes, and complete circumferential contact was visualized with the fiberoptic endoscopic component in 15 of 16 PVs accessed (94%). Contact was also confirmed by the absence of color Doppler flow through the balloon-occluded PV, as seen on ICE. On two occasions a gap was seen with the fiberoptic endoscope and visualized by the ICE only after optimization of the echo window. No complications were observed. CONCLUSIONS: The ELRBC is able to access the PV without complications. The endoscope and ICE were complementary for positioning of the balloon at the LA-PV junction and for the definition of circumferential contact.