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.

[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.

Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data.

OBJECTIVE: We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy. METHODS: A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered. RESULTS: The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively. CONCLUSIONS: This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.

Modeling cost-effectiveness and health gains of a "universal" versus "prioritized" hepatitis C virus treatment policy in a real-life cohort.

We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virus-infected patients: policy 1, "universal," treat all patients, regardless of fibrosis stage; policy 2, treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus-infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies' cost-effectiveness. The patients' age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of €30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 post-sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (€15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis. CONCLUSION: Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost-effective; cost-effectiveness significantly increases when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814-1825).

A simple risk tool (the OBSERVANT score) for prediction of 30-day mortality after transcatheter aortic valve replacement.

Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate <45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction <40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system.

Different impact of sex on baseline characteristics and major periprocedural outcomes of transcatheter and surgical aortic valve interventions: Results of the multicenter Italian OBSERVANT Registry.

BACKGROUND: Despite the widespread use of transcatheter aortic valve implantation (TAVI), the role of sex on outcome after TAVI or surgical aortic valve replacement (AVR) has been poorly investigated. We investigated the impact of sex on outcome after TAVI or AVR. METHODS: There were 2108 patients undergoing TAVI or AVR who were enrolled in the Italian Observational Multicenter Registry (OBSERVANT). Thirty-day mortality, major periprocedural morbidity, and transprosthetic gradients were stratified by sex according to interventions. RESULTS: Female AVR patients showed a worse risk profile compared with male AVR patients, given the higher mean age, prevalence of frailty score of 2 or higher, New York Heart Association class of 3 or higher, lower body weight, and preoperative hemoglobin level (P ≤ .02). Similarly, female TAVI patients had a different risk profile than male TAVI patients, given a higher age and a lower body weight and preoperative hemoglobin level (P ≤ .005), but with a similar New York Heart Association class, frailty score, EuroSCORE (P = NS), a better left ventricular ejection fraction and a lower prevalence of left ventricular ejection fraction less than 30%, porcelain aorta, renal dysfunction, chronic obstructive pulmonary disease, arteriopathy, and previous cardiovascular surgery or percutaneous coronary intervention (P ≤ .01). Women showed a smaller aortic annulus than men in both populations (P < .001). Female sex was an independent predictor in the AVR population for risk-adjusted 30-day mortality (odds ratio [OR], 2.34; P = .043) and transfusions (OR, 1.47; P = .003), but not for risk-adjusted acute myocardial infarction, stroke, vascular complications, permanent atrioventricular block (P = NS). Female sex was an independent predictor in the TAVI population for risk-adjusted major vascular complications (OR, 2.92; P = .018) and transfusions (OR, 1.93; P = .003), but proved protective against moderate to severe postprocedural aortic insufficiency (P = .018). CONCLUSIONS: Female sex is a risk factor for mortality after aortic valve replacement, for major vascular complications after TAVI, and for transfusions after both approaches.

Role of gender and age on early mortality after coronary artery bypass graft in different hospitals: data from a national administrative database.

The aim of this study is to evaluate the effect of gender and age on outcome following coronary surgery in several hospitals enrolled in a national quality assessment program. Patients undergoing isolated coronary artery bypass graft (CABG) during 2003-2005 in Italy were included in the study (n=74,577). The outcome measure was 30-day in-hospital mortality. Comorbidities recorded during previous and current hospitalizations were used to define patients' health status and to build the adjustment model. The interaction term (gender*hospital) was introduced into the model to test the effect modification of gender; if present, gender specific models were analyzed to test the effect modification of age. A significant effect modification by gender was found in 39 hospitals; the adjusted odds ratios (AdjORs) showed significant increased risk for females (AdjORs ranging from 3.7 to 21.6). In three of these hospitals a significant increased risk was found for older age (AdjORs for elderly patients ranging from 8.1 to 14.6). Two hospitals showed a significant excess risk for patients ≥75 years (AdjORs=6.6 and 13.8). The technical aspects of surgery could account for the excess risk found in female patients; differences in the entire care process (intraoperative and postoperative management) could explain the variations in outcome among elderly patients.

Reliability of cardiac dimensions and valvular regurgitation assessment by sonographers using hand-carried ultrasound devices.

AIM: We sought to assess the reliability of some basic echocardiographic data obtained by trained sonographers using a hand-held ultrasound device. METHODS: One hundred and twelve consecutive patients (mean age 61, 64 males) referred for in-hospital or ambulatory routine echocardiography were considered. All patients underwent two-dimensional and colour Doppler examination performed by a trained sonographer equipped with a hand-held ultrasound device and by a certified cardiologist equipped with a standard platform, in random order. Indexed left ventricular end-diastolic and end-systolic transverse diameters, aortic root, end-systolic left atrium transverse diameter, end-diastolic interventricular septum and posterior wall thickness were calculated by two-dimensional left parasternal long-axis view in blind conditions. Mitral and aortic valve regurgitation were investigated by colour-Doppler imaging on parasternal and apical views and compared using a 0 to 4 semi-quantitative score. RESULTS: Overall feasibility was high for both settings (sonographers: 93%; cardiologists: 95%; P not significant). Excellent concordance of end-diastolic diameter (kappa 0.75), left atrium (kappa 0.76) and interventricular septum thickness (kappa 0.77) results was found. Good concordance was observed for end-systolic diameter (kappa 0.66), aortic root (kappa 0.64) and posterior wall thickness (kappa 0.67) results. A high linear correlation between the couples of results was present for all parameters. A good agreement of the mitral (kappa 0.66) and aortic (kappa 0.84) regurgitation scores was also found, with a low prevalence of discordant results (mitral regurgitation: 22%, aortic regurgitation: 9%) and no > or =2-point discrepancies. CONCLUSION: In a general population referred for Doppler echocardiography, basic cardiac linear dimensions and valvular regurgitation severity assessment by trained sonographers using hand-held ultrasound devices appear accurate and reliable for routine clinical use.