Financial Burden of Transcatheter Aortic Valve Implantation.

Given the increasing population eligible for transcatheter aortic valve implantation (TAVI), resource utilization has become an important focus in this setting. We aimed to estimate the change in the financial burden of TAVI therapy over 2 different periods. A probabilistic Markov model was developed to estimate the cost consequences of increased center experience and the introduction of newer-generation TAVI devices compared with an earlier TAVI period in a cohort of 6,000 patients. The transition probabilities and hospitalization costs were retrieved from the OBSERVANT (Observational Study of Effectiveness of AVR-TAVI procedures for severe Aortic steNosis Treatment) and OBSERVANT II (Observational Study of Effectiveness of TAVI with new generation deVices for severe Aortic stenosis Treatment) studies, including 1,898 patients treated with old-generation devices and 1,417 patients treated with new-generation devices. The propensity score matching resulted in 853 pairs, with well-balanced baseline risk factors. The mean EuroSCORE II (6.6% vs 6.8%, p = 0.76) and the mean age (82.0 vs 82.1 y, p = 0.62) of the early TAVI period and new TAVI period were comparable. The new TAVI period was associated with a significant reduction in rehospitalizations (-30.5% reintervention, -25.2% rehospitalization for major events, and -30.8% rehospitalization for minor events) and a 20% reduction in 1-year mortality. These reductions resulted in significant cost savings over a 1-year period (-€4.1 million in terms of direct costs and -€19.7 million considering the additional cost of the devices). The main cost reduction was estimated for rehospitalization, accounting for 79% of the overall cost reduction (not considering the costs of the devices). In conclusion, the introduction of new-generation TAVI devices, along with increased center experience, led to significant cost savings at 1-year compared with an earlier TAVI period, mainly because of the reduction in rehospitalization costs.

Socioeconomic factors and bleeding events in patients with incident atrial fibrillation: A Finnish nationwide cohort study.

Background: Low socioeconomic status has been associated with higher risk of ischemic stroke and death in patients with atrial fibrillation (AF). However, whether socioeconomic status affects risk of bleeding events is unknown. We assessed the hypothesis that low income and educational attainment are associated with higher risk of bleeding in patients with AF. Methods: The registry-based FinACAF study covers all patients with AF in Finland during 2007-2018. Patients were divided into income quartiles and three categories based on their educational attainment. Outcomes of interest were the first-ever gastrointestinal (GI), intracranial (IC) and any bleeding. Results: We identified 205 019 patients (50.9 % female; mean age 72.3 (SD 13.4) years) with incident AF without prior bleeding. Mean follow-up time was 4.0 (SD 3.2) years, during which 25 013 (12.2 %) patients experienced first-ever any bleeding (incidence rate 3.07 (95 % CI 3.03-3.10) /100 patient-years). Low income was independently associated with hazard of any bleeding as well as GI and IC bleeding (adjusted hazard ratios (HRs) comparing lowest vs highest income quartile: 1.13 (1.08-1.17), 1.32 (1.23-1.41) and 1.15 (1.06-1.24), respectively). Income-related bleeding disparities were larger among younger patients under 65 years and among men. Education-related bleeding disparities were smaller than income related-disparities (adjusted HRs comparing lowest vs highest educational category: any bleeding 1.06 (1.02-1.11), GI bleeding 1.16 (1.08-1.24), IC bleeding 1.10 (0.93-1.09)). Conclusions: Patients with AF and low income are at higher risk of bleeding, especially GI bleeding.

Socioeconomic disparities in use of rhythm control therapies in patients with incident atrial fibrillation: A Finnish nationwide cohort study.

Background: In patients with atrial fibrillation (AF), socioeconomic disparities have been reported in the use of oral anticoagulant therapy and outcomes, but whether income also affects the utilization of antiarrhythmic therapies (AATs) for rhythm control is unknown. We assessed the hypothesis that AF patients with higher income are more likely to receive AATs. Methods: The nationwide retrospective registry based FinACAF cohort study covers all patients with AF from all levels of care in Finland. Patients were divided in AF diagnosis year and age-group specific income quintiles according to their highest annual income during 2004-2018. The primary outcome was the use of any AAT, including cardioversion, catheter ablation, and fulfilled antiarrhythmic drug (AAD) prescription. Results: We identified 188 175 patients (mean age 72.6 ± 13.0 years; 49.6% female) with incident AF during 2010-2018. Patients in higher income quintiles had consistently higher use of all AAT modalities. When compared to patients in the lowest income quintile, the adjusted incidence rate ratios (95% CI) in the highest quintile were 1.53 (1.48-1.59) for any AAT, 1.71 (1.61-1.81) for AADs, 1.43 (1.37-1.49) for cardioversion, and 2.00 (1.76-2.27) for catheter ablation. No temporal change during study period was observed in the magnitude of income disparities in AAT use, except for a decrease in income-related differences in the use of AADs. Conclusion: Profound income-related disparities exist in AAT use among patients with AF in Finland, especially in the use catheter ablation.

Income and outcomes of patients with incident atrial fibrillation.

BACKGROUND: Socioeconomic disparities can be associated with adverse outcomes in patients with cardiovascular diseases. The impact of personal income on the outcomes of patients with atrial fibrillation (AF) is unclear. METHODS: Nationwide observational registry-based study on patients with incident AF in Finland during 2007-2018. RESULTS: 203 154 patients (mean age 73.0±13.5; females 49.0%) were diagnosed with incident AF during the study period. Overall, 16 272 (8.0%) patients experienced first-ever ischaemic stroke and 63 420 (31.2%) died (mean follow-up 4.3±3.3 years). After adjusting for confounding factors, low personal income was associated with increased risk of overall mortality in all age strata and the incidence of first-ever stroke in patients aged <65 years and 65-74 years, but not in those ≥75 years. The magnitude of this effect was greatest in patients aged <65 years. After propensity score matching of patients <65 years in the lowest and highest quintiles of maximum personal annual income, at 10 years, those in the highest income quintile (≥€54 000) had significantly lower risk of first-ever stroke (subdistribution HR 0.495, 95% CI 0.391 to 0.628) and overall mortality (HR 0.307, 95% CI 0.269 to 0.351) compared with patients in the lowest income quintile (≤€12 000). CONCLUSIONS: Personal annual income has a significant impact on the incidence of first-ever ischaemic stroke and overall mortality among patients with incident AF, particularly among patients of working age. Low-income indicate the need for intervention strategies to improve outcomes of AF. TRIAL REGISTRATION NUMBER: NCT04645537.

[The PRIORITY study - PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY]. / Lo studio PRIORITY - PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY.

The allocation of clinical and economic resources is an emerging issue in health management. A useful update necessarily depends on the evaluation of long-term outcomes of clinical and surgical resources that can permit emphasis on all amendable fields, improve quality of care, and reduce health costs. The PRIORITY (PRedictIng long term Outcomes afteR Isolated coronary arTery bypass surgerY) study represents the first innovative step toward the updating of health management in a selected field, surgery for coronary artery disease, which is one of the most prevalent diseases and requires allocation of high-cost resources, although information on long-term outcomes is limited. The aims of the PRIORITY study are the identification of preoperative risk factors for long-term outcomes and the development of clinical and administrative preoperative scores that can guide clinicians and the national health system to more appropriate actions for increasing quality of care and reducing costs.

Hemodynamic assessment of Perceval sutureless bioprosthesis by dobutamine stress echocardiography.

OBJECTIVES: The aim of this study was to evaluate the hemodynamic performance of a sutureless bioprosthesis under high workload at mid-term follow-up. METHODS: Thirty-two patients who underwent isolated aortic valve replacement with a Perceval sutureless bioprosthesis with a minimum follow-up of 1 year were enrolled in this study. S size prosthesis was deployed in 10 patients (31.3%), M size in 9 (28.1%), L size in 8 (25%) and XL size in 5 (15.6%). Effective orifice area (EOA), EOA index (EOAi), and transvalvular gradients were assessed at rest and during dobutamine stress echocardiography (DSE) a median of 19.5 months after surgery. RESULTS: Dobutamine stress echocardiography (DSE) significantly increased heart rate, stroke volume, ejection fraction, and transvalvular gradients (peak gradient, 24.0 ± 7.6 vs 38.7 ± 13.6 mm Hg, P < .001; mean gradient, 12.6 ± 4.2 vs 19.8 ± 8.3, P < .001). When compared to baseline, estimated valve areas significantly increased at follow-up (EOA, 1.48 ± 0.46 vs 2.06 ± 0.67, P < .001; EOAi, 0.84 ± 0.26 vs 1.17 ± 0.37, P < .001). Mean percentage increase in EOAi was 40.3% ± 28.0%. S size prostheses had the highest increase in EOA1, but the difference was not significant (S 46.0% ± 27.5% vs M 45.4% ± 34.5% vs L 32.7% ± 26.4% vs XL 32.1% ± 20.5%, P = .66). Severe patient-prosthesis mismatch (EOAi ≤ 0.65 cm2 /m2 ) was present at rest in 8 patients (25%), but only in one patient (3.1%) during DSE. CONCLUSIONS: The Perceval sutureless bioprosthesis demonstrated good hemodynamics at rest and under high workload. The significant increase in EOAi during DSE suggests the potential advantages of Perceval sutureless bioprostheses in case of small aortic annulus or when patient-prosthesis mismatch is anticipated.

Perioperative coagulation assessment of patients undergoing major elective orthopedic surgery.

Traditional coagulative parameters are of limited use in identifying perioperative coagulopathy occurring in patients undergoing major elective orthopedic surgery (MEOS). The aim of our study was to evaluate the coagulation changes in patients undergoing MEOS and to facilitate an early detection of perioperative coagulopathy in patients experiencing major intraoperative bleeding. We enrolled 40 consecutive patients (M/F 10/30, age range 34-90 years) who underwent MEOS at the Orthopedic Unit of the Padua University Hospital, Italy, between January 2014 and January 2015. Blood samples were obtained at the following time points: T0-pre: 30 min before surgery; T0-post: 30 min after the end of the procedure; T1: morning of the first postoperative day; T2: 7 ± 2 days after surgery. Patients who experienced an intraoperative blood loss ≥250 mL/h were considered as cases. Routine coagulative parameters, thromboelastometry and thrombin generation (TG) profiles were evaluated. At baseline, a significantly lower platelet count and FIBTEM MCF/AUC were observed in patents with excessive bleeding (p < 0.05 and 0.02/0.01, respectively). At T0-post and T1 intervals, cases showed hypocoagulation characterized by a significantly low platelet count (p = 0.001), prolonged CFT INTEM/EXTEM, reduction of alpha-angle and MaxV INTEM/EXTEM, MCF and AUC INTEM/EXTEM/FIBTEM (p < 0.05 in all comparisons). The only TG parameter standing out between study groups was time to peak at T0-pre. A low platelet count and fibrinogen activity were associated with significant intraoperative bleeding in patients undergoing MEOS. Thromboelastometry performed by ROTEM(®) identifies patients with coagulopathy.

Finnvasc score and modified Prevent III score predict long-term outcome after infrainguinal surgical and endovascular revascularization for critical limb ischemia.

BACKGROUND: Estimation of the risk of adverse long-term outcome is of paramount importance in the treatment of critical limb ischemia (CLI). METHODS: We evaluated the accuracy of two specific risk score systems, the Finnvasc score and the modified Prevent III (mPIII) score, in 1425 CLI patients who underwent unilateral, infrainguinal surgical (47.6%) or endovascular (52.4%) revascularization. The receiver operating characteristic (ROC) curve analysis was used to estimate the predictive value of these risk scoring methods. RESULTS: The area under the ROC curve of Finnvasc score for prediction of 30-day amputation was 0.609 (95% confidence interval [CI] 0.549-0.677) and of mPIII score 0.533 (95% CI 0.457-0.609). The area under ROC curve of Finnvasc score for prediction of 30-day amputation-free survival was 0.622 (95% CI 0.573-0.671) and of mPIII score 0.588 (95% CI 0.533-0.642). The area under the ROC curve of Finnvasc score for prediction of 1-year amputation-free survival was 0.630 (95% CI 0.597-0.663, P<.0001) and of mPIII score 0.634 (95% CI 0.600-0.667, P<.0001). Finnvasc score predicted leg salvage (relative risk [RR] 1.431, 95% CI 1.319-1.551), survival (RR 1.233, 95% CI 1.116-1.363), and amputation-free survival (RR 1.422, 95% CI 1.319-1.534). mPIII score also predicted leg salvage (RR 1.190, 95% CI 1.108-1.277), survival (RR 1.245, 95% CI 1.193-1.300), and amputation-free survival (RR 1.223, 95% CI 1.176-1.272). CONCLUSIONS: Finnvasc and modified PIII risk scoring methods predict long-term outcome of patients undergoing infrainguinal revascularization for CLI. Finnvasc score seems to perform well also in predicting immediate postoperative outcome.

Risk prediction in patients undergoing elective endovascular repair of an abdominal aortic aneurysm.

OBJECTIVES: The aim of this study was to retrospectively evaluate three risk scoring methods in predicting outcome after elective endovascular repair of an abdominal aortic aneurysm. DESIGN: A Zenith stent graft was employed in 205 patients during years 2001-2005. RESULTS: The 30-day postoperative mortality rate was 2.9%. Receiver operating characteristics (ROC) curve analysis showed that the Glasgow aneurysm score (GAS) (AUC: 0.843, p=0.004) and the Giles' score (AUC 0.815, p=0.009) had a rather large area under the curve in predicting 30-day mortality rate. The modified Leiden score was much less accurate (AUC: 0.594). The best cut-off value for the GAS in predicting 30-day mortality was 90 (0.6% vs. 17.9%, p<0.0001). Patients with a GAS > or = 90 had a 4-year survival rate of 56.8%, whereas it was 78.5% among those with a lower GAS (p = 0.001). The best cut-off value for the Giles' score was 11 (1.3% vs. 8.3%, p<0.0001). Patients with a Giles' score > or = 11 had a 4-year survival rate of 63.9%, whereas it was 79.0% among those with a lower score (p = 0.016). CONCLUSIONS: The GAS and Giles' risk scoring methods are good predictors of poor immediate and late outcome after EVAR.