Search

Background: The PARTNER 3 trial demonstrated clinical benefits of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device, over surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic stenosis (sSAS) at low risk of surgical mortality. Using PARTNER 3 outcomes and Italy-specific costs data, this cost-utility analysis from the perspective of the Italian National Health System aimed to determine the cost-effectiveness of SAPIEN 3 TAVI versus SAVR in low risk sSAS patients in Italy., Methods: A two-stage cost-utility model was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured utilising the PARTNER 3 dataset. These data fed into a Markov model that captured longer-term outcomes of patients, following TAVI or SAVR intervention., Results: Analysis findings estimated that TAVI with SAPIEN 3 offers benefits over SAVR in terms of increased quality-adjusted life years (QALYs) with only a small increase in costs, representing an incremental cost-effectiveness ratio/QALY gained of €2989 per patient. The results were robust, with TAVI with SAPIEN 3 remaining cost-effective across several scenarios and in probabilistic sensitivity analyses., Conclusions: This model demonstrated that TAVI with SAPIEN 3 is likely to be cost effective compared with SAVR for the treatment of patients with sSAS who are at low risk of surgical mortality. These findings can inform policy makers to facilitate policy development in Italy on intervention selection for this patient population., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding., Methods: From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset., Results: AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively., Conclusions: In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aims: To compare the effects of two thrombus aspiration devices, the manual catheter Export® and the more complex and expensive mechanical Angiojet®, on several indices of reperfusion in acute ST-elevation myocardial infarction (STEMI)., Methods and Results: Clinical, hemodynamic and procedural characteristics of 185 STEMI patients, randomized to treatment with Export (n=95) or Angiojet (n=90) during primary percutaneous coronary intervention (PPCI) were analyzed. The primary endpoint was ST-segment elevation reduction 90 min after culprit vessel re-opening. Secondary endpoints included variations in some angiographic parameters (TIMI Flow, TIMI Frame Count and Myocardial Blush Grade) and Infarct Size and Severity at myocardial scintigraphy. A significant reduction in ST-elevation was observed in both groups after PPCI without significant differences between the two groups. No significant difference between Angiojet vs. Export was observed in ST-segment resolution >50% and ≥ 70%, in TIMI Flow, TIMI Frame Count and Myocardial Blush Grade before vs. after PPCI and in Infarct Size and Severity., Conclusions: PPCI with thrombus aspiration was effective in both groups of patients, without differences in myocardial reperfusion and necrosis indices. These results could support the routine use of manual devices during PPCI, reserving the more expensive Angiojet in case of manual device failure and persistent or massive intracoronary thrombosis, with favorable implications in terms of cost containment., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)