Case report: Self-expanding transcatheter valve implantation (Acurate Neo 2) in a very small native aortic annulus

Transcatheter aortic valve replacement (TAVR) is a treatment of choice in patients with symptomatic severe aortic valve stenosis (AS) and intermediate-to-high surgical risk. The presence of a small aortic annulus (SAA) has been associated with a higher incidence of prosthesis–patient mismatch (PPM) when surgical aortic valve replacement (sAVR) is performed. TAVR might be a treatment option offering better hemodynamics with a lower incidence of PPM. When a severe AS with a SAA is treated, TAVR-related risk as the coronary obstruction and the annulus rupture, must be also prevented. We present a case of a TAVR in a very small aortic annulus; to our knowledge, this is the smallest native aortic annulus treated percutaneously in a tricuspid stenotic aortic valve with a Self-Expanding Transcatheter Heart Valve (THV) Acurate Neo 2

El labrador: Año I Número 3 - (14/03/22)

BACKGROUND: Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. METHODS: Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. RESULTS: The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. CONCLUSIONS: Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values

Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial.

BACKGROUND: Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. METHODS: Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. RESULTS: The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was ¿430 more costly than BMS (¿8,305 vs. ¿7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of ¿3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of ¿25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. CONCLUSIONS: Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values

Impact of Diabetes on 10‐Year Outcomes Following ST‐Segment–Elevation Myocardial Infarction: Insights From the EXAMINATION‐EXTEND Trial

BACKGROUND: Long-term outcomes of ST-segment-elevation myocardial infarction in patients with diabetes have been barely investigated. The objective of this analysis from the EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION trial) trial was to compare 10-year outcomes of patients with ST-segment-elevation myocardial infarction with and without diabetes. METHODS AND RESULTS: Of the study population, 258 patients had diabetes and 1240 did not. The primary end point was patient-oriented composite end point of all-cause death, any myocardial infarction, or any revascularization. Secondary end points were the individual components of the primary combined end point, cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis. All end points were adjusted for potential confounders. At 10 years, patients with diabetes showed a higher incidence of patient-oriented composite end point compared with those without (46.5% versus 33.0%; adjusted hazard ratio [HR], 1.31 [95% CI, 1.05-1.61]; P=0.016) mainly driven by a higher incidence of any revascularization (24.4% versus 16.6%; adjusted HR, 1.61 [95% CI, 1.19-2.17]; P=0.002). Specifically, patients with diabetes had a higher incidence of any revascularization during the first 5 years of follow-up (20.2% versus 12.8%; adjusted HR, 1.57 [95% CI, 1.13-2.19]; P=0.007) compared with those without diabetes. No statistically significant differences were found with respect to the other end points. CONCLUSIONS: Patients with ST-segment-elevation myocardial infarction who had diabetes had worse clinical outcome at 10 years compared with those without diabetes, mainly driven by a higher incidence of any revascularizations in the first 5 years