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350 results on '"Rosato, S."'

4. CDKN2A and BAP1 germline mutations predispose to melanoma and mesothelioma

Author

Betti, M., Aspesi, A., Biasi, A., Casalone, E., Ferrante, D., Ogliara, P., Gironi, L.C., Giorgione, R., Farinelli, P., Grosso, F., Libener, R., Rosato, S., Turchetti, D., Maffè, A., Casadio, C., Ascoli, V., Dianzani, C., Colombo, E., Piccolini, E., Pavesi, M., Miccoli, S., Mirabelli, D., Bracco, C., Righi, L., Boldorini, R., Papotti, M., Matullo, G., Magnani, C., Pasini, B., and Dianzani, I.

Published
2016
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5. Zinc and Mowat-Wilson Syndrome

Author

Garavelli, Livia, Marangi, G., Rosato, S., Zollino, Marcella, Kretsinger, Robert H., editor, Uversky, Vladimir N., editor, and Permyakov, Eugene A., editor

Published
2013
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6. Early and mid-term outcome of patients with low-flow–low-gradient aortic stenosis treated with newer-generation transcatheter aortic valves

Author

Fraccaro, C, Tarantini, G, Rosato, S, Baglio, G, Biancari, F, Barbanti, M, Tamburino, C, Bedogni, F, Ranucci, M, Ussia, Gp, Seccareccia, F, D'Errigo, P, Appendix, I, Ruvolo, G, Nardi, P, Pisano, C, HUS Heart and Lung Center, University of Helsinki, and Helsinki University Hospital Area

Subjects
left ventricular dysfunction, low-flow–low-gradient, Settore MED/23, valvular heart disease, Aortic stenosis, 3121 General medicine, internal medicine and other clinical medicine, transcatheter aortic valve replacement, Low-flow-low-gradient, Cardiology and Cardiovascular Medicine
Abstract

Patients with non-paradoxical low-flow–low-gradient (LFLG) aortic stenosis (AS) are at increased surgical risk, and thus, they may particularly benefit from transcatheter aortic valve replacement (TAVR). However, data on this issue are still limited and based on the results with older-generation transcatheter heart valves (THVs). The aim of this study was to investigate early and mid-term outcome of TAVR with newer-generation THVs in the setting of LFLG AS. Data for the present analysis were gathered from the OBSERVANT II dataset, a national Italian observational, prospective, multicenter cohort study that enrolled 2,989 consecutive AS patients who underwent TAVR at 30 Italian centers between December 2016 and September 2018, using newer-generation THVs. Overall, 420 patients with LVEF ≤50% and mean aortic gradient n = 389) with those who underwent surgical aortic valve replacement (SAVR, n = 401) from the OBSERVANT I study. Patients with LFLG AS undergoing TAVR were old (mean age, 80.8 ± 6.7 years) and with increased operative risk (mean EuroSCORE II, 11.5 ± 10.2%). VARC-3 device success was 83.3% with 7.6% of moderate/severe paravalvular leak. Thirty-day mortality was 3.1%. One-year all-cause mortality was 17.4%, and the composite endpoint was 34.8%. Chronic obstructive pulmonary disease (HR 1.78) and EuroSCORE II (HR 1.02) were independent predictors of 1-year mortality, while diabetes (HR 1.53) and class NYHA IV (HR 2.38) were independent predictors of 1-year mortality or CHF. Compared with LFLG AS treated with SAVR, TAVR patients had a higher rate of major vascular complications and permanent pacemaker, while SAVR patients underwent more frequently to blood transfusion, cardiogenic shock, AKI, and MI. However, 30-day and 1-year outcomes were similar between groups. Patients with non-paradoxical LFLG AS treated by TAVR were older and with higher surgical risk compared with SAVR patients. Notwithstanding, TAVR was safe and effective with a similar outcome to SAVR at both early and mid-term.

Published
2022
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7. RF44 OUTCOME AFTER BILATERAL INTERNAL MAMMARY ARTERY GRAFTING IN HIGH- AND LOW-VOLUME HOSPITALS: AN ANALYSIS OF THE E-CABG REGISTRY

Author

Saccocci, M., Perotti, A., Reichart, D., Gatti, G., Faggian, G., Onorati, F., Feo, M. De, Chocron, S., Dalen, M., Santarpino, G., Rubino, A.S., Maselli, D., Gherli, R., Salsano, A., Nicolini, F., Zanobini, M., Bounader, K., Seccareccia, F., Rosato, S., Tauriainen, T., Mariscalco, G., Ruggieri, V.G., and Biancari, F.

Published
2018
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8. OC11 CLINICAL FRAILTY SCALE AND OUTCOME AFTER CORONARY ARTERY BYPASS GRAFTING: AN ANALYSIS OF THE E-CABG REGISTRY

Author

Saccocci, M., Reichart, D., Rosato, S., Nammas, W., Onorati, F., Dalen, M., Castro, L., Gherli, R., Gatti, G., Franzese, I., Faggian, G., De Feo, M., Khodabandeh, S., Santarpino, G., Rubino, A.S., Maselli, D., Nardella, S., Salsano, A., Nicolini, F., Zanobini, M., Bounader, K., Kinnunen, E., Tauriainen, T., Airaksinen, J., Seccareccia, F., Mariscalco, G., Ruggieri, V.G., Perrotti, A., and Biancari, F.

Published
2018
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9. OC87 VALUE OF SCREENING ASYMPTOMATIC CAROTID ARTERY STENOSIS PRIOR TO CORONARY ARTERY BYPASS GRAFTING: ANALYSIS OF THE E-CABG REGISTRY

Author

Salsano, A., Santarpino, G., Santini, F., Nicolini, F., De Feo, M., Dalén, M., Fischlein, T., Perrotti, A., Reichart, D., Gatti, G., Onorati, F., Franzese, I., Faggian, G., Bancone, C., Chocron, S., Khodabandeh, S., Rubino, A.S., Maselli, D., Nardella, S., Gherli, R., Zanobini, M., Saccocci, M., Bounader, K., Rosato, S., Tauriainen, T., Mariscalco, G., Airaksinen, J., Ruggieri, V.G., and Biancari, F.

Published
2018
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10. OC88 COMPARATIVE ANALYSIS OF PROTHROMBIN COMPLEX CONCENTRATE AND FRESH FROZEN PLASMA IN THE MANAGEMENT OF PERIOPERATIVE BLEEDING AFTER CORONARY ARTERY BYPASS GRAFTING

Author

Salsano, A., Mariscalco, G., Santini, F., Ruggieri, V.G., Perrotti, A., Chocron, S., Gherli, R., Reichart, D., Demal, T., Faggian, G., Franzese, I., Dalén, M., Santarpino, G., Fischlein, T., Rubino, A.S., Maselli, D., Nardella, S., Nicolini, F., Saccocci, M., Gatti, G., Bounader, K., Rosato, S., Kinnunen, E., De Feo, M., Tauriainen, T., Onorati, F., and Biancari, F.

Published
2018
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11. Prematurity, ventricular septal defect and dysmorphisms are independent predictors of pathogenic copy number variants: a retrospective study on array-CGH results and phenotypical features of 293 children with neurodevelopmental disorders and/or multiple congenital anomalies

Author

Maini, I., Ivanovski, I., Djuric, O., Caraffi, S. G., Errichiello, E., Marinelli, M., Franchi, F., Bizzarri, V., Rosato, S., Pollazzon, M., Gelmini, C., Malacarne, M., Fusco, C., Gargano, G., Bernasconi, S., Zuffardi, O., and Garavelli, L.

Published
2018
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12. Real-life use of elbasvir/grazoprevir in adults and elderly patients: a prospective evaluation of comedications used in the PITER cohort

Author

Quaranta M. G., Rosato S., Ferrigno L., Amoruso D. C., Monti M., Di Stefano P., Filomia R., Biliotti E., Migliorino G., Russo F. P., Degasperi E., Chemello L., Brancaccio G., Blanc P., Cannizzaro M., Barbaro F., Morsica G., Licata A., Kondili L. A., on behalf of PITER Collaborating group, Federico A., Dallio M., Loguercio C., Quaranta, M. G., Rosato, S., Ferrigno, L., Amoruso, D. C., Monti, M., Di Stefano, P., Filomia, R., Biliotti, E., Migliorino, G., Russo, F. P., Degasperi, E., Chemello, L., Brancaccio, G., Blanc, P., Cannizzaro, M., Barbaro, F., Morsica, G., Licata, A., Kondili, L. A., on behalf of PITER Collaborating, Group, Federico, A., Dallio, M., Loguercio, C., Quaranta M.G., Rosato S., Ferrigno L., Amoruso D.C., Monti M., Di Stefano P., Filomia R., Biliotti E., Migliorino G., Russo F.P., Degasperi E., Chemello L., Brancaccio G., Blanc P., Cannizzaro M., Barbaro F., Morsica G., Licata A., and Kondili L.A.

Subjects
Male, 030312 virology, combination therapy, treatment experienced patients, Drug Combination, chronic hepatitis C, drug drug interactions, virus genotype 1, treatment experienced patients, pump inhibitor use, combination therapy, treatment naive, liver fibrosis,grazoprevir, elbasvir, 80 and over, Age Factor, Pharmacology (medical), Drug Interactions, Prospective Studies, Chronic, Prospective cohort study, liver fibrosis, Aged, 80 and over, 0303 health sciences, Age Factors, Imidazoles, Middle Aged, Hepatitis C, Drug Combinations, Infectious Diseases, Treatment Outcome, Drug Interaction, Grazoprevir, Cohort, drug drug interactions, Female, pump inhibitor use, Human, medicine.drug, medicine.medical_specialty, Elbasvir, Quinoxaline, treatment naive, elbasvir, Antiviral Agents, NO, 03 medical and health sciences, Internal medicine, Quinoxalines, medicine, chronic hepatitis C, Elbasvir, Grazoprevir, Humans, Imidazole, Aged, Benzofurans, Antiviral Agent, Pharmacology, business.industry, grazoprevir, Carbamazepine, Hepatitis C, Chronic, medicine.disease, Comorbidity, Discontinuation, Benzofuran, business, virus genotype 1
Abstract

Background In patients treated for HCV infection, potential drug–drug interactions (DDIs) can occur among direct-acting antiviral drugs (DAAs) and comedications used. The real-life effectiveness and safety of elbasvir/grazoprevir (ELB/GZR) among co-medicated HCV patients was evaluated. Methods We prospectively evaluated consecutive patients from 15 clinical centres participating in PITER who were treated with ELB/GZR and had been followed for at least 12 weeks after treatment. Data were prospectively collected on the use of comedications (including discontinuation, dose modification and addition of drugs) and potential DDIs with DAAs. Results Of the 356 patients with at least 12-week post-treatment follow-up (median age 67, range 50–88 years), 338 (95%) achieved sustained virological response. Of these, 219 (60%) had at least one comorbidity (median 2, range 1–6); information on comedication was available for 212 of them. Of 190 comedications used, 15 (8%) drugs were modified during ELB/GZR therapy, specifically in 9 (4%) patients they were interrupted, in 2 (1%) of whom, the comedication was interrupted before the DAA therapy because of potential DDI (that is, patients treated with carbamazepine); in 12 (6%) patients the comedications were modified in terms of dosage. In 29 (14%) patients, the comedications required monitoring when used with ELB/GZR, as well as with all available DAAs. Of the 190 drugs, 27 (14%) used in 67% of patients were free of DDIs when used with ELB/GZR, whereas they required monitoring if used with other DAA regimens. Conclusions The results of this prospective study support findings that ELB/GZR is effective and safe in most treated patients.

Published
2020

13. Late myocardial infarction and repeat revascularization after coronary artery bypass grafting in patients with prior percutaneous coronary intervention

Author

Biancari, F. (Fausto), Salsano, A. (Antonio), Santini, F. (Francesco), De Feo, M. (Marisa), Dalén, M. (Magnus), Zhang, Q. (Qiyao), Gatti, G. (Giuseppe), Mazzaro, E. (Enzo), Franzese, I. (Ilaria), Bancone, C. (Ciro), Zanobini, M. (Marco), Tauriainen, T. (Tuomas), Mäkikallio, T. (Timo), Saccocci, M. (Matteo), Francica, A. (Alessandra), Rosato, S. (Stefano), El-Dean, Z. (Zein), Onorati, F. (Francesco), Mariscalco, G. (Giovanni), Biancari, F. (Fausto), Salsano, A. (Antonio), Santini, F. (Francesco), De Feo, M. (Marisa), Dalén, M. (Magnus), Zhang, Q. (Qiyao), Gatti, G. (Giuseppe), Mazzaro, E. (Enzo), Franzese, I. (Ilaria), Bancone, C. (Ciro), Zanobini, M. (Marco), Tauriainen, T. (Tuomas), Mäkikallio, T. (Timo), Saccocci, M. (Matteo), Francica, A. (Alessandra), Rosato, S. (Stefano), El-Dean, Z. (Zein), Onorati, F. (Francesco), and Mariscalco, G. (Giovanni)

Abstract

Objectives: The aim of the present study was to evaluate the risk of late mortality and major adverse cardiovascular and cerebral events after coronary artery bypass grafting (CABG) in patients with prior percutaneous coronary intervention (PCI). Methods: A total of 2948 patients undergoing isolated CABGs were included in a prospective multicenter registry. Outcomes were adjusted for multiple covariates in logistic regression, Cox proportional hazards analysis and competing risk analysis. Results: In all, 2619 patients fulfilled the inclusion criteria of this analysis. Of them, 2199 (79.1%) had no history of PCI and 420 (20.9%) had a prior PCI. An adjusted analysis showed that a single prior PCI and multiple prior PCIs did not increase the risk of 30-day and 5-year mortality. Patients with multiple prior PCIs had a significantly higher risk of 5-year myocardial infarction (SHR 2.566, 95%CI 1.379–4.312) and repeat revascularization (SHR 1.774, 95%CI 1.140–2.763). Similarly, 30-day and 5-year mortality were not significantly increased in patients with prior PCI treatment of single or multiple vessels. Patients with multiple vessels treated with PCI had a significantly higher risk of 5-year myocardial infarction (SHR 2.640, 95%CI 1.497–4.658), repeat revascularization (SHR 1.648, 95%CI 1.029–2.638) and stroke (SHR 2.215, 95%CI 1.056–4.646) at 5-year. The risk for repeat revascularization was also increased with a prior single vessel PCI, but not for other outcomes. Conclusions: Among patients undergoing CABGs, multiple prior PCIs seem to increase the risk of late myocardial infarction and the need for repeat revascularization, but not the risk of mortality.

Published
2022

14. Transcatheter and surgical aortic valve replacement in patients with left ventricular dysfunction

Author

Jalava, M. P. (Maina P.), Savontaus, M. (Mikko), Ahvenvaara, T. (Tuomas), Laakso, T. (Teemu), Virtanen, M. (Marko), Niemelä, M. (Matti), Tauriainen, T. (Tuomas), Maaranen, P. (Pasi), Husso, A. (Annastiina), Kinnunen, E. (Eve), Dahlbacka, S. (Sebastian), Jaakkola, J. (Jussi), Rosato, S. (Stefano), D’Errigo, P. (Paola), Laine, M. (Mika), Mäkikallio, T. (Timo), Raivio, P. (Peter), Eskola, M. (Markku), Valtola, A. (Antti), Juvonen, T. (Tatu), Biancari, F. (Fausto), Airaksinen, J. (Juhani), Anttila, V. (Vesa), Jalava, M. P. (Maina P.), Savontaus, M. (Mikko), Ahvenvaara, T. (Tuomas), Laakso, T. (Teemu), Virtanen, M. (Marko), Niemelä, M. (Matti), Tauriainen, T. (Tuomas), Maaranen, P. (Pasi), Husso, A. (Annastiina), Kinnunen, E. (Eve), Dahlbacka, S. (Sebastian), Jaakkola, J. (Jussi), Rosato, S. (Stefano), D’Errigo, P. (Paola), Laine, M. (Mika), Mäkikallio, T. (Timo), Raivio, P. (Peter), Eskola, M. (Markku), Valtola, A. (Antti), Juvonen, T. (Tatu), Biancari, F. (Fausto), Airaksinen, J. (Juhani), and Anttila, V. (Vesa)

Abstract

Background: Patients with severe aortic stenosis and left ventricular systolic dysfunction have a poor prognosis, and this may result in inferior survival also after aortic valve replacement. The outcomes of transcatheter and surgical aortic valve replacement were investigated in this comparative analysis. Methods: The retrospective nationwide FinnValve registry included data on patients who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis for severe aortic stenosis. Propensity score matching was performed to adjust the outcomes for baseline covariates of patients with reduced (≤ 50%) left ventricular ejection fraction. Results: Within the unselected, consecutive 6463 patients included in the registry, the prevalence of reduced ejection fraction was 20.8% (876 patients) in the surgical cohort and 27.7% (452 patients) in the transcatheter cohort. Reduced left ventricular ejection fraction was associated with decreased survival (adjusted hazards ratio 1.215, 95%CI 1.067–1.385) after a mean follow-up of 3.6 years. Among 255 propensity score matched pairs, 30-day mortality was 3.1% after transcatheter and 7.8% after surgical intervention (p = 0.038). One-year and 4-year survival were 87.5% and 65.9% after transcatheter intervention and 83.9% and 69.6% after surgical intervention (restricted mean survival time ratio, 1.002, 95%CI 0.929–1.080, p = 0.964), respectively. Conclusions: Reduced left ventricular ejection fraction was associated with increased morbidity and mortality after surgical and transcatheter aortic valve replacement. Thirty-day mortality was higher after surgery, but intermediate-term survival was comparable to transcatheter intervention. Trial registration: The FinnValve registry ClinicalTrials.gov Identifier: NCT03385915.

Published
2022

19. One-Year Outcomes and Trends over Two Eras of Transcatheter Aortic Valve Implantation in Real-World Practice

Author

Costa, G, D'Errigo, P, Rosato, S, Biancari, F, Marcellusi, A, Tarantini, G, Santoro, G, Baiocchi, M, Maffeo, D, Fiorina, C, Cerza, F, Baglio, G, Juvonen, T, Badoni, G, Valvo, R, Seccareccia, F, Barbanti, M, Tamburino, C, Appendix, Ruvolo, G, Nardi, P, Pisano, C, HUS Heart and Lung Center, and University of Helsinki

Subjects
trends, REPLACEMENT, Settore MED/23, OBSERVANT, Outcomes, Transcatheter aortic valve implantation, Trends, TRANSFEMORAL TRANSCATHETER, 3121 General medicine, internal medicine and other clinical medicine, NEW-GENERATION DEVICES, General Medicine, transcatheter aortic valve implantation, outcomes, NEXT-DAY DISCHARGE
Abstract

Background: Data reflecting the benefit of procedural improvements in real-world transcatheter aortic valve implantation (TAVI) practice are sparse. Aims: To compare outcomes and trends of two TAVI eras from real Italian practice. Methods: A total of 1811 and 2939 TAVI patients enrolled in the national, prospective OBSERVANT and OBSERVANT II studies in 2010–2012 and 2016–2018, respectively, were compared in a cohort study. Outcomes were adjusted using inverse propensity of treatment weighting and propensity score matching. Results: The median age (83.0 (79.0–86.0) vs. 83.0 (79.0–86.0)) and EuroSCORE II (5.2 (3.2–7.7) vs. 5.1 (3.1–8.1)) of OBSERVANT and OBSERVANT II patients were similar. At 1 year, patients of the OBSERVANT II study had a significantly lower risk of all-cause death (10.6% vs. 16.3%, Hazard Ratio (HR) 0.63 (95% Confidence Interval (CI) 0.52–0.76)) and rehospitalization for heart failure (HF) (14.3% vs. 19.5%, Sub-distribution HR 0.71 (95%CI 0.60–0.84)), whereas rates of stroke (3.1% vs. 3.6%) and permanent pacemaker implantation (PPI) (16.6% vs. 18.0%) were comparable between study groups. Conclusions: Age and risk profile among patients undergoing TAVI in Italy remained substantially unchanged between the 2010–2012 and 2016–2018 time periods. After adjustment, patients undergoing TAVI in the most recent era had lower risk of all-cause death and rehospitalization for HF at 1 year, whereas rates of stroke and PPI did not differ significantly.

Published
2022
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20. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author

Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., Ieluzzi D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., and Ieluzzi D.

Abstract

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.

Published
2019

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

Author

Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L. A., Vella, S., Quaranta, M. G., Rosato, S., Tosti, M. E., Weimer, L. E., Ferrigno, L., D’Angelo, F., Falzano, L., Benedetti, A., Schiadà, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Di Leo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, Peter, Rimenti, G., Rossini, A., Contessi, G. B., Castelli, Fulvio, Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, Lucia, Quintieri, F., De Siena, Martina, Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall’Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., DelundefinedPin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, Francesca, Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., DiundefinedBiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, Chiara, Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D’ArminioundefinedMonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, Margherita, D’Ambrosio, R., Degasperi, E., Vinci, Maria Rosaria, Villa, E., Bernabucci, V., Bristot, Luca, Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, Alex, Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D’Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, Enrico, Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, Maria Chiara, Montalto, G., Licata, A., Capitano, A. R., Craxì, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, Paolo, Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, Antonio, Siciliano, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D’Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, Roberto, Cingolani, Antonella, Lamonica, S., D’Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, Antonio, D’Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, Patrizia, Dell’Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, Monia, Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Kondili LA, Vella S, Quaranta MG, Rosato S, Tosti ME, Weimer LE, Ferrigno L, D'Angelo F, Falzano L, Benedetti A, Schiadà L, Cucco M, Giacometti A, Brescini L, Castelletti S, Drenaggi D, Mazzaro C, Angarano G, Milella M, Di Leo A, Rendina M, Contaldo A, Iannone A, La Fortezza F, Rizzi M, Cologni G, Bolondi L, Benevento F, Serio I, Andreone P, Caraceni P, Guarneri V, Margotti M, Simonetti G, Mazzella G, Verucchi G, Donati V, Mian P, Rimenti G, Rossini A, Contessi GB, Castelli F, Zaltron S, Spinetti A, Odolini S, Leandro G, Cozzolongo R, Zappimbulso M, Russello M, Benigno R, Coco C, Torti C, Costa C, Greco G, Mazzitelli M, Pisani V, Cosco L, Quintieri F, De Siena M, Giancotti F, Vecchiet J, Falasca K, Mastroianni A, Apuzzo G, Chidichimo L, Foschi FG, Dall'Aglio AC, Libanore M, Segala D, Sighinolfi L, Bartolozzi D, Salomoni E, Blanc P, Baragli F, Del Pin B, Mariabelli E, Mazzotta F, Poggi A, Zignego AL, Monti M, Madia F, Xheka A, Cela EM, Santantonio TA, Bruno SR, Viscoli C, Alessandrini AI, Curti C, Di Biagio A, Nicolini LA, Balletto E, Mastroianni C, Blerta K, Prati D, Raffaele L, Andreoletti M, Perboni G, Costa P, Manzini L, Raimondo G, Filomia R, Lazzarin A, Morsica G, Salpietro S, Puoti M, Baiguera C, Vassalli S, Rumi MG, Labanca S, Zuin M, Giorgini A, Orellana D, D'Arminio Monforte A, Debona A, Solaro S, Fargion S, Valenti L, Periti G, Pelusi S, Galli M, Calvi E, Milazzo L, Peri A, Lampertico P, Borghi M, D'Ambrosio R, Degasperi E, Vinci M, Villa E, Bernabucci V, Bristot L, Pereira F, Chessa L, Pasetto MC, Loi M, Gori A, Beretta I, Pastore V, Soria A, Strazzabosco M, Ciaccio A, Gemma M, Borgia G, Foggia A, Zappulo E, Gentile I, Buonomo AR, Abrescia N, Maddaloni A, Caporaso N, Morisco F, Camera S, Donnarumma L, Coppola C, Amoruso DC, Staiano L, Saturnino MR, Coppola N, Martini S, Monari C, Federico A, Dallio M, Loguercio C, Gaeta GB, Brancaccio G, Nardone G, Sgamato C, D'Adamo G, Alberti A, Gonzo M, Piovesan S, Chemello L, Buggio A, Cavalletto L, Barbaro F, Castelli E, Floreani A, Cazzagon N, Franceschet I, Russo FP, Zanetto A, Franceschet E, Madonia S, Cannizzaro M, Montalto G, Licata A, Capitano AR, Craxì A, Petta S, Calvaruso V, Rini F, Ferrari C, Negri E, Orlandini A, Pesci M, Bruno R, Lombardi A, Zuccaro V, Gulminetti R, Asti A, Villaraggia M, Mondelli M, Ludovisi S, Baldelli F, Di Candilo F, Parruti G, Di Stefano P, Sozio F, Gizzi MC, Brunetto MR, Colombatto P, Coco B, Surace L, Foti G, Pellicano S, Fornaciari G, Schianchi S, Vignoli P, Massari M, Corsini R, Garlassi E, Ballardini G, Andreoni M, Cerva C, Angelico M, Gasbarrini A, Siciliano M, De Siena M, Nosotti L, Taliani G, Biliotti E, Santori M, Spaziante M, Tamburini F, Vullo V, D'Ettorre G, Cavallari EN, Gebremeskel TS, Pavone P, Cauda R, Cingolani A, Lamonica S, D'Offizi G, Lionetti R, Visco Comandini U, Grieco A, D'Aversa F, Picardi A, De Vincentis A, Galati G, Gallo P, Dell'Unto C, Aghemo A, Gatti Comini A, Persico M, Masarone M, Anselmo M, De Leo P, Marturano M, Brunelli E, Ridolfi F, Schimizzi AM, Ayoubi Khajekini M, Framarin L, Di Perri G, Cariti G, Boglione L, Cardellino C, Marinaro L, Saracco GM, Ciancio A, Toniutto P, Alterini G, Capra F, Ieluzzi D., Marcellusi, A., Viti, R., Kondili, L. A., Rosato, S., Vella, S., Mennini, F. S., Quaranta, M. G., Tosti, M. E., Weimer, L. E., Ferrigno, L., D'Angelo, F., Falzano, L., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Dileo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, P., Rimenti, G., Rossini, A., Contessi, G. B., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, L., Quintieri, F., Desiena, M., Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall'Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., Delpin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, F., Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., Dibiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, C., Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D'Arminiomonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Vinci, M., Villa, E., Bernabucci, V., Bristot, L., Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, A., Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D'Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, E., Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, M., Montalto, G., Licata, A., Capitano, A. R., Craxi, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, P., Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, A., Siciliano, M., De Siena, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D'Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, R., Cingolani, A., Lamonica, S., D'Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, A., D'Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, P., Dell'Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, M., Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L.A., Quaranta, M.G., Tosti, M.E., Weimer, L.E., D’Angelo, F., Schiadà, L., Di&nbsp, Leo, A., Contessi, G.B., De&nbsp, Siena, M., Foschi, F.G., Dall’Aglio, A.C., Del&nbsp, Pin, B., Zignego, A.L., Cela, E.M., Santantonio, T.A., Bruno, S.R., Alessandrini, A.I., Biagio, A., Nicolini, L.A., Rumi, M.G., D’Arminio&nbsp, Monforte, A., D’Ambrosio, R., Pasetto, M.C., Buonomo, A.R., Amoruso, D.C., Saturnino, M.R., Gaeta, G.B., D’Adamo, G., Russo, F.P., Capitano, A.R., Craxì, A., Gizzi, M.C., Brunetto, M.R., D’Ettorre, G., Cavallari, E.N., Gebremeskel, T.S., D’Offizi, G., D’Aversa, F., Dell’Unto, C., Schimizzi, A.M., Saracco, G.M., Cosco, Alfredo, Dall’Aglio, A. C., Salomoni, Valentina, Nicolini, Elvira, Calvi, Marta, Soria, Giovanni, D'Adamo, Danilo, ALONSO ALBERTI, MARIA PALOMA CARMEN, Orlandini, Giovanni, DE ASTIS, Fabio, Sozio, Concetta, Terzini, Angelico, DE SIENA, ANDREA URIEL, Taliani, Sabrina, Spaziante, Agata, Lamonica, Emilia, and Capra, Carlo

Subjects
Liver Cirrhosis, Pediatrics, Time Factors, Settore MED/09 - Medicina Interna, National Health Programs, ERADICATION, OUTBREAK, antiviral treatment, anti HCV, economic consequences, Hepacivirus, LIVER FIBROSIS, Severity of Illness Index, Health Services Accessibility, COST-EFFECTIVENESS, Indirect costs, 0302 clinical medicine, Epidemiology, virus infection, 030212 general & internal medicine, health care economics and organizations, cost effectiveness, 030503 health policy & services, Health Policy, Health services research, health, Hepatitis C, Markov Chains, chronic hepatitis C, virus infection, fibrosis progression, cost effectiveness, liver fibrosis, Italy, Pharmacology, Public Health, Environmental and Occupational Health, Cohort, Settore SECS-P/03 - Scienza delle Finanze, Disease Progression, Public Health, 0305 other medical science, Viral hepatitis, Anti-HCV antiviral treatment, CHRONIC HEPATITIS-C, medicine.medical_specialty, Genotype, Settore MED/12 - GASTROENTEROLOGIA, VIRUS-INFECTION, Antiviral Agents, NO, 03 medical and health sciences, Cost Savings, Humans, medicine, MANAGEMENT, chronic hepatitis C, INDUCED DISEASES, METAANALYSIS, Health economics, business.industry, Public health, Environmental and Occupational Health, medicine.disease, FIBROSIS PROGRESSION, business
Abstract

OBJECTIVE:\ud 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.\ud \ud METHODS:\ud 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.\ud \ud RESULTS:\ud 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.\ud \ud CONCLUSIONS:\ud 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.

Published
2019

22. One-year outcomes after surgical versus transcatheter aortic valve replacement with newer generation devices

Author

Rosato, S, Biancari, F, D'Errigo, P, Barbanti, M, Tarantini, G, Bedogni, F, Ranucci, M, Costa, G, Juvonen, T, Ussia, Gp, Marcellusi, A, Baglio, G, Cicala, Sd, Badoni, G, Seccareccia, F, Tamburino, C, On Behalf Of The Observant Ii Research Group, Appendix, I, Ruvolo, G, Nardi, P, Pisano, C, HUS Heart and Lung Center, III kirurgian klinikka, and Department of Surgery

Subjects
medicine.medical_specialty, medicine.medical_treatment, 030204 cardiovascular system & hematology, Lower risk, Article, 03 medical and health sciences, Transcatheter aortic valve implantation (TAVI), 0302 clinical medicine, Aortic valve replacement, Valve replacement, Internal medicine, medicine, Transcatheter aortic valve replacement (TAVR), aortic valve replacement, 030212 general & internal medicine, Adverse effect, Prospective cohort study, Stroke, METAANALYSIS, transcatheter aortic valve replacement (TAVR), transcatheter aortic valve implantation (TAVI), business.industry, General Medicine, 3126 Surgery, anesthesiology, intensive care, radiology, medicine.disease, Stenosis, Settore MED/23, Heart failure, SURVIVAL, Cardiology, Medicine, IMPLANTATION, business
Abstract

The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), and acute kidney injury (0.6 vs. 8.2%, p &lt, 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, p &lt, 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, p &lt, 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p &lt, 0.001), and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33–0.71), in females (HR 0.57, 0.38–0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32–0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR.

Published
2021

23. Long-term outcomes after ascending aortic replacement and aortic root replacement for type A aortic dissection

Author

Jormalainen, M. (Mikko), Kesävuori, R. (Risto), Raivio, P. (Peter), Vento, A. (Antti), Mustonen, C. (Caius), Honkanen, H.-P. (Hannu-Pekka), Rosato, S. (Stefano), Simpanen, J. (Jarmo), Teittinen, K. (Kari), Biancari, F. (Fausto), Juvonen, T. (Tatu), Jormalainen, M. (Mikko), Kesävuori, R. (Risto), Raivio, P. (Peter), Vento, A. (Antti), Mustonen, C. (Caius), Honkanen, H.-P. (Hannu-Pekka), Rosato, S. (Stefano), Simpanen, J. (Jarmo), Teittinen, K. (Kari), Biancari, F. (Fausto), and Juvonen, T. (Tatu)

Abstract

Objectives: We investigated whether the selective use of supracoronary ascending aorta replacement achieves late outcomes comparable to those of aortic root replacement for acute Stanford type A aortic dissection (TAAD). Methods: Patients who underwent surgery for acute type A aortic dissection from 2005 to 2018 at the Helsinki University Hospital, Finland, were included in this analysis. Late mortality was evaluated with the Kaplan–Meier method and proximal aortic reoperation, i.e. operation on the aortic root or aortic valve, with the competing risk method. Results: Out of 309 patients, 216 underwent supracoronary ascending aortic replacement and 93 had aortic root replacement. At 10 years, mortality was 33.8% after aortic root replacement and 35.2% after ascending aortic replacement (P = 0.806, adjusted hazard ratio 1.25, 95% confidence interval, 0.77–2.02), and the cumulative incidence of proximal aortic reoperation was 6.0% in the aortic root replacement group and 6.2% in the ascending aortic replacement group (P = 0.65; adjusted subdistributional hazard ratio 0.53, 95% confidence interval 0.15–1.89). Among 71 propensity score matched pairs, 10-year survival was 34.4% after aortic root replacement and 36.2% after ascending aortic replacement surgery (P = 0.70). Cumulative incidence of proximal aortic reoperation was 7.0% after aortic root replacement and 13.0% after ascending aortic replacement surgery (P = 0.22). Among 102 patients with complete imaging data [mean follow-up, 4.7 (3.2) years], the estimated growth rate of the aortic root diameter was 0.22 mm/year, that of its area 7.19 mm2/year and that of its perimeter 0.43 mm/year. Conclusions: When stringent selection criteria were used to determine the extent of proximal aortic reconstruction, aortic root replacement and ascending aortic replacement for type A aortic dissection achieved comparable clinical outcomes.

Published
2021

24. One-year outcomes after surgical versus transcatheter aortic valve replacement with newer generation devices

Author

Rosato, S. (Stefano), Biancari, F. (Fausto), D’Errigo, P. (Paola), Barbanti, M. (Marco), Tarantini, G. (Giuseppe), Bedogni, F. (Francesco), Ranucci, M. (Marco), Costa, G. (Giuliano), Juvonen, T. (Tatu), Ussia, G. P. (Gian Paolo), Marcellusi, A. (Andrea), Baglio, G. (Giovanni), Cicala, S. D. (Stefano Domenico), Badoni, G. (Gabriella), Seccareccia, F. (Fulvia), Tamburino, C. (Corrado), The OBSERVANT II Research Group, . (), Rosato, S. (Stefano), Biancari, F. (Fausto), D’Errigo, P. (Paola), Barbanti, M. (Marco), Tarantini, G. (Giuseppe), Bedogni, F. (Francesco), Ranucci, M. (Marco), Costa, G. (Giuliano), Juvonen, T. (Tatu), Ussia, G. P. (Gian Paolo), Marcellusi, A. (Andrea), Baglio, G. (Giovanni), Cicala, S. D. (Stefano Domenico), Badoni, G. (Gabriella), Seccareccia, F. (Fulvia), Tamburino, C. (Corrado), and The OBSERVANT II Research Group, . ()

Abstract

The superiority of transcatheter (TAVR) over surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS) has not been fully demonstrated in a real-world setting. This prospective study included 5706 AS patients who underwent SAVR from 2010 to 2012 and 2989 AS patients who underwent TAVR from 2017 to 2018 from the prospective multicenter observational studies OBSERVANT I and II. Early adverse events as well as all-cause mortality, major adverse cardiac and cerebrovascular events (MACCEs), and hospital readmission due to heart failure at 1-year were investigated. Among 1008 propensity score matched pairs, TAVR was associated with significantly lower 30-day mortality (1.8 vs. 3.5%, p = 0.020), stroke (0.8 vs. 2.3%, p = 0.005), and acute kidney injury (0.6 vs. 8.2%, p < 0.001) compared to SAVR. Moderate-to-severe paravalvular regurgitation (5.9 vs. 2.0%, p < 0.001) and permanent pacemaker implantation (13.8 vs. 3.3%, p < 0.001) were more frequent after TAVR. At 1-year, TAVR was associated with lower risk of all-cause mortality (7.9 vs. 11.5%, p = 0.006), MACCE (12.0 vs. 15.8%, p = 0.011), readmission due to heart failure (10.8 vs. 15.9%, p < 0.001), and stroke (3.2 vs. 5.1%, p = 0.033) compared to SAVR. TAVR reduced 1-year mortality in the subgroups of patients aged 80 years or older (HR 0.49, 95% CI 0.33–0.71), in females (HR 0.57, 0.38–0.85), and among patients with EuroSCORE II ≥ 4.0% (HR 0.48, 95% CI 0.32–0.71). In a real-world setting, TAVR using new-generation devices was associated with lower rates of adverse events up to 1-year follow-up compared to SAVR.

Published
2021

25. Infection Control Practices and Outcomes of Endoscopy Units in the Lombardy Region of Italy A Survey From the Italian Society of Digestive Endoscopy During COVID-19 Spread

Author

Capurso, G., Archibugi, L., Vanella, G., Testoni, S. G. G., Petrone, M. C., Fanti, Lucrezia, Greco, Sara, Cavenati, S., Gaffuri, N., Lella, F., Pace, F., Cengia, G., Spada, Cristiano, Lovera, Mauro, Missale, G., Rosato, S., Radaelli, F., Buscarini, E., Parente, F., Pilati, S., Luigiano, C., Passoni, G. R., Salerno, R., Bargiggia, S., Penagini, R., Cantu, P., Fregoni, F., Giannetti, A., Devani, M., Manes, G., Fiori, G., Fontana, Paolo, Gambitta, P., Masci, E., Mutignani, Massimiliano, Gatti, M., Canani, M. B., Vailati, C., Dinelli, M. E., Marzo, V., Alvisi, C., Caramia, V., Di Sabatino, A., Mauro, A., De Grazia, F., Balzarini, M., Segato, S., Nella, G. A., Giannini, P., Leoni, Paola, Testoni, P. A., Mariani, A., Arcidiacono, P. G., Fanti L. (ORCID:0000-0003-2457-6373), Greco S., Spada C. (ORCID:0000-0002-5692-0960), Lovera M., Fontana P., Mutignani M. (ORCID:0000-0002-1272-4888), Leoni P., Capurso, G., Archibugi, L., Vanella, G., Testoni, S. G. G., Petrone, M. C., Fanti, Lucrezia, Greco, Sara, Cavenati, S., Gaffuri, N., Lella, F., Pace, F., Cengia, G., Spada, Cristiano, Lovera, Mauro, Missale, G., Rosato, S., Radaelli, F., Buscarini, E., Parente, F., Pilati, S., Luigiano, C., Passoni, G. R., Salerno, R., Bargiggia, S., Penagini, R., Cantu, P., Fregoni, F., Giannetti, A., Devani, M., Manes, G., Fiori, G., Fontana, Paolo, Gambitta, P., Masci, E., Mutignani, Massimiliano, Gatti, M., Canani, M. B., Vailati, C., Dinelli, M. E., Marzo, V., Alvisi, C., Caramia, V., Di Sabatino, A., Mauro, A., De Grazia, F., Balzarini, M., Segato, S., Nella, G. A., Giannini, P., Leoni, Paola, Testoni, P. A., Mariani, A., Arcidiacono, P. G., Fanti L. (ORCID:0000-0003-2457-6373), Greco S., Spada C. (ORCID:0000-0002-5692-0960), Lovera M., Fontana P., Mutignani M. (ORCID:0000-0002-1272-4888), and Leoni P.

Abstract

Goals: The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area. Background: Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy. Methods: A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak. Results: In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P = 0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found. Conclusions: Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.

Published
2021

26. Corrigendum to “Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV” [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou A., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou A., Han X., Kondili L. A., Taliani G., Ciancio A., Morisco F., Critelli R. M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A. S., Bruno S., Bao Y., Gonzalez Y. S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M. C., Bigliotti E., Tamburrini F., Montalto G., Capitano A. R., Ieluzzi D., Fattovich G., Zignego A. L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F. P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D. C., Andreone P., Simonetti G., Gaeta G. B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L. E., Quaranta M. G., Falzano L., Mallano A., Karampatou A., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou A., Han X., Kondili L. A., Taliani G., Ciancio A., Morisco F., Critelli R. M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A. S., Bruno S., Bao Y., Gonzalez Y. S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M. C., Bigliotti E., Tamburrini F., Montalto G., Capitano A. R., Ieluzzi D., Fattovich G., Zignego A. L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F. P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D. C., Andreone P., Simonetti G., Gaeta G. B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L. E., Quaranta M. G., Falzano L., and Mallano A.

Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

27. Early and late outcomes after transcatheter versus surgical aortic valve replacement in obese patients

Author

Mariscalco, G, D’Errigo, P, Biancari, F, Rosato, S, Musumeci, F, Barbanti, M, Ranucci, M, Santoro, G, Badoni, G, Fusco, D, Ventura, M, Tamburino, C, Seccareccia, F, Appendix, I, Ruvolo, G, Pisano, C, and Nardi, P

Subjects
medicine.medical_specialty, obesity, Blood transfusion, Transcatheter aortic, business.industry, medicine.medical_treatment, General Medicine, medicine.disease, mortality, Settore MED/23, Aortic valve replacement, Clinical Research, Internal medicine, Baseline characteristics, Cohort, Propensity score matching, medicine, Cardiology, aortic valve replacement, Permanent pacemaker, business, Body mass index, transcatheter aortic valve implantation
Abstract

Introduction: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients. Material and methods: Obese patients (body mass index ≥ 30 kg/m²) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed. Propensity score matching was employed to identify two cohorts with similar baseline characteristics. Results: The propensity score matching provided 142 pairs balanced in terms of baseline risk factors. In-hospital and 30-day mortality did not differ between SAVR and TAVI obese patients (4.6% vs. 3.3%, p = 0.56, and 5.2% vs. 3.2%, p = 0.41, respectively). Obese SAVR patients experienced a higher rate of renal failure (12.4% vs. 3.6%, p = 0.0105) and blood transfusion requirement (60.3% vs. 25.7%, p < 0.0001) in comparison with TAVI patients. A higher rate of permanent pacemaker implantation (14.4% vs. 3.6%, p = 0.0018), and major vascular injuries (7.4% vs. 0%, p = 0.0044) occurred in the TAVI group. Five-year survival was higher in the SAVR group compared to the TAVI patient cohort (p = 0.0046), with survival estimates at 1, 3 and 5 years of 88.0%, 80.3%, 71.8% for patients undergoing SAVR, and 85.2%, 69.0%, 52.8% for those subjected to TAVI procedures. Conclusions: In obese patients, both SAVR and TAVI are valid treatment options, although in the long term SAVR exhibited higher survival rates.

Published
2020

28. Transcatheter or surgical treatment of severe aortic stenosis and coronary artery disease: A comparative analysis from the Italian OBSERVANT study

Author

Barbanti, M, Buccheri, S, Capodanno, D, D'Errigo, P, Ranucci, M, Rosato, S, Santoro, G, Fusco, D, Tamburino, C, Biancari, F, Seccareccia, F, Appendix, I, Pisano, C, Ruvolo, G, and Nardi, P

Subjects
Male, Cardiac Catheterization, medicine.medical_specialty, medicine.medical_treatment, Coronary Artery Disease, 030204 cardiovascular system & hematology, Revascularization, Severity of Illness Index, TAVI, Transcatheter Aortic Valve Replacement, Coronary artery disease, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Aortic valve replacement, Internal medicine, 80 and over, medicine, Humans, Prospective Studies, cardiovascular diseases, 030212 general & internal medicine, Myocardial infarction, Coronary Artery Bypass, CABG, Aged, Aortic stenosis, PCI, SAVR, Aged, 80 and over, Aortic Valve Stenosis, Female, Heart Valve Prosthesis Implantation, Italy, Survival Rate, Treatment Outcome, business.industry, Percutaneous coronary intervention, medicine.disease, Settore MED/23, Stenosis, Concomitant, Conventional PCI, Cardiology, Cardiology and Cardiovascular Medicine, business
Abstract

Background To assess clinical outcomes of patients with concomitant severe aortic stenosis (AS) and coronary artery disease (CAD) who underwent transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) or surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG). Methods Data were extracted from the multicenter OBSERVANT study. For the purposes of the present analysis, we included only patients with established stable CAD meeting any of the following inclusion criteria: 1) TAVI patients with CAD undergoing staged PCI or TAVI and PCI in the same session; 2) SAVR patients undergoing combined SAVR and CABG in the same session. Results After propensity-score matching, a total of 472 patients (236 per group) were identified. Among TAVI patients, PCI was performed prior to the procedure in 217 patients (92.0%), whereas concomitant TAVI and PCI were performed in 19 patients (8.0%). At 3-year, there was no difference in survival between the two groups (KM estimate of freedom from death for SAVR and TAVI patients of 0.742 and 0.650, respectively; log-rank p-value of 0.105). The rate of MACCE was comparable between the two groups (KM estimate of freedom from MACCE for SAVR and TAVI patients of 0.683 and 0.582, respectively; log-rank p-value of 0.115). Conclusions In patients with associated severe AS and CAD, percutaneous treatment (TAVR and staged or concomitant PCI) was comparable to surgical treatment (SAVR and concomitant CABG) with respect to the early and mid-term risk of death from any cause, myocardial infarction, stroke and unplanned revascularization.

Published
2018

29. Early and late outcomes after transcatheter versus surgical aortic valve replacement in obese patients

Author

Mariscalco, G. (Giovanni), D’Errigo, P. (Paola), Biancari, F. (Fausto), Rosato, S. (Stefano), Musumeci, F. (Francesco), Barbanti, M. (Marco), Ranucci, M. (Marco), Santoro, G. (Gennaro), Badoni, G. (Gabriella), Fusco, D. (Danilo), Ventura, M. (Martina), Tamburino, C. (Corrado), Seccareccia, F. (Fulvia), Mariscalco, G. (Giovanni), D’Errigo, P. (Paola), Biancari, F. (Fausto), Rosato, S. (Stefano), Musumeci, F. (Francesco), Barbanti, M. (Marco), Ranucci, M. (Marco), Santoro, G. (Gennaro), Badoni, G. (Gabriella), Fusco, D. (Danilo), Ventura, M. (Martina), Tamburino, C. (Corrado), and Seccareccia, F. (Fulvia)

Abstract

Introduction: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients. Material and methods: Obese patients (body mass index ≥ 30 kg/m²) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed. Propensity score matching was employed to identify two cohorts with similar baseline characteristics. Results: The propensity score matching provided 142 pairs balanced in terms of baseline risk factors. In-hospital and 30-day mortality did not differ between SAVR and TAVI obese patients (4.6% vs. 3.3%, p = 0.56, and 5.2% vs. 3.2%, p = 0.41, respectively). Obese SAVR patients experienced a higher rate of renal failure (12.4% vs. 3.6%, p = 0.0105) and blood transfusion requirement (60.3% vs. 25.7%, p < 0.0001) in comparison with TAVI patients. A higher rate of permanent pacemaker implantation (14.4% vs. 3.6%, p = 0.0018), and major vascular injuries (7.4% vs. 0%, p = 0.0044) occurred in the TAVI group. Five-year survival was higher in the SAVR group compared to the TAVI patient cohort (p = 0.0046), with survival estimates at 1, 3 and 5 years of 88.0%, 80.3%, 71.8% for patients undergoing SAVR, and 85.2%, 69.0%, 52.8% for those subjected to TAVI procedures. Conclusions: In obese patients, both SAVR and TAVI are valid treatment options, although in the long term SAVR exhibited higher survival rates.

Published
2020

30. Comparison of survival of transfemoral transcatheter aortic valve implantation versus surgical aortic valve replacement for aortic stenosis in low-risk patients without coronary artery disease

Author

Virtanen, M. P. (Marko P.O.), Airaksinen, J. (Juhani), Niemelä, M. (Matti), Laakso, T. (Teemu), Husso, A. (Annastiina), Jalava, M. P. (Maina P.), Tauriainen, T. (Tuomas), Maaranen, P. (Pasi), Kinnunen, E.-M. (Eeva-Maija), Dahlbacka, S. (Sebastian), Rosato, S. (Stefano), Savontaus, M. (Mikko), Juvonen, T. (Tatu), Laine, M. (Mika), Mäkikallio, T. (Timo), Valtola, A. (Antti), Raivio, P. (Peter), Eskola, M. (Markku), Biancari, F. (Fausto), Virtanen, M. P. (Marko P.O.), Airaksinen, J. (Juhani), Niemelä, M. (Matti), Laakso, T. (Teemu), Husso, A. (Annastiina), Jalava, M. P. (Maina P.), Tauriainen, T. (Tuomas), Maaranen, P. (Pasi), Kinnunen, E.-M. (Eeva-Maija), Dahlbacka, S. (Sebastian), Rosato, S. (Stefano), Savontaus, M. (Mikko), Juvonen, T. (Tatu), Laine, M. (Mika), Mäkikallio, T. (Timo), Valtola, A. (Antti), Raivio, P. (Peter), Eskola, M. (Markku), and Biancari, F. (Fausto)

Abstract

Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score <3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (p = 1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (p = 0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD.

Published
2020

31. Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis

Author

Virtanen, M. P. (Marko P. O.), Eskola, M. (Markku), Savontaus, M. (Mikko), Juvonen, T. (Tatu), Niemelä, M. (Matti), Laakso, T. (Teemu), Husso, A. (Annastiina), Jalava, M. P. (Maina P.), Tauriainen, T. (Tuomas), Ahvenvaara, T. (Tuomas), Maaranen, P. (Pasi), Kinnunen, E.-M. (Eeva-Maija), Dahlbacka, S. (Sebastian), Laine, M. (Mika), Mäkikallio, T. (Timo), Valtola, A. (Antti), Raivio, P. (Peter), Rosato, S. (Stefano), D’Errigo, P. (Paola), Vento, A. (Antti), Airaksinen, J. (Juhani), Biancari, F. (Fausto), Virtanen, M. P. (Marko P. O.), Eskola, M. (Markku), Savontaus, M. (Mikko), Juvonen, T. (Tatu), Niemelä, M. (Matti), Laakso, T. (Teemu), Husso, A. (Annastiina), Jalava, M. P. (Maina P.), Tauriainen, T. (Tuomas), Ahvenvaara, T. (Tuomas), Maaranen, P. (Pasi), Kinnunen, E.-M. (Eeva-Maija), Dahlbacka, S. (Sebastian), Laine, M. (Mika), Mäkikallio, T. (Timo), Valtola, A. (Antti), Raivio, P. (Peter), Rosato, S. (Stefano), D’Errigo, P. (Paola), Vento, A. (Antti), Airaksinen, J. (Juhani), and Biancari, F. (Fausto)

Abstract

Background: There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis. Methods: In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality. Results: A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts. Conclusions: The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome.

Published
2020

32. Weed control for tall fescue seed production and stand duration without burning

Author

Mueller-Warrant, George W. and Rosato, S. Caprice

Subjects
Incineration -- Research, Tall fescue -- Control -- Research, Weeds -- Control, Agricultural industry, Business, Control, Research
Abstract

Effective weed control was a major concern of Oregon grass seed growers during their recent transition from open-field burning to mechanical methods of managing post-harvest residues. This 4-yr herbicide by residue management study was conducted to determine: (i) efficacy of herbicides on volunteer tall fescue (Festuca arundinacea Schreb.) seedlings and other weeds, (ii) whether treatments required for weed-free seed production could be reapplied annually without damaging stands, (iii) occurrence of interactions between herbicides and crop residue management, and (iv) increases in grassy weeds over time. Nearly all herbicide treatments controlled volunteer tall fescue seedlings with bale/flail chop/rake residue removal. Vacuum sweep residue removal improved control over bale/flail chop/rake in many cases, and controlled seedlings even without herbicides in 1995. Incorporation of pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl2,6-dinitrobenzenamine] improved weed control in bale/flail chop/rake and residueretained conditions. Although carryover treatment effects reduced weed seedling survival in later years of production and sometimes reduced tall fescue seed yield, specific treatments existed which controlled weeds for all 4 yr without reducing yield. Interactions between residue management and herbicide treatments included reduced efficacy of pendimethalin in residue-retained management, higher yields at equal weed densities in residue-removed conditions, and higher weed densities from equivalent herbicide treatments in residue-retained conditions. Roughstalk bluegrass (Poa trivialis L.) increased over time in some treatments and was a major cause for reduced yields in later years of production. Tall fescue seed growers must risk some current-year yield loss from herbicide injury to avoid greater losses in future years from perennial weeds like roughstalk bluegrass., GRASSSEED PRODUCTION in western Oregon under went a mandatory transition between 1990 and 1996 from open-field burning to mechanical methods of removing or otherwise processing post-harvest residues. Early research had [...]

Published
2005

40. Corrigendum to 'Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV' [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou, A., Han, X., Kondili, L. A., Taliani, G., Ciancio, A., Morisco, F., Critelli, R. M., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A. S., Bruno, S., Bao, Y., Gonzalez, Y. S., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou A., Han X., Kondili L.A., Taliani G., Ciancio A., Morisco F., Critelli R.M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A.S., Bruno S., Bao Y., Gonzalez Y.S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M.C., Bigliotti E., Tamburrini F., Montalto G., Capitano A.R., Ieluzzi D., Fattovich G., Zignego A.L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F.P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D.C., Andreone P., Simonetti G., Gaeta G.B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L.E., Quaranta M.G., Falzano L., and Mallano A.

Subjects
Hepatology, Hepatitis B, EASL guidelines, Treatment, Interferon, Entecavir, Tenofovir, TAF, HBsAg, Hepatocellular carcinoma, HBV DNA, HBV reactivation, Mother to child transmission, EASL guideline
Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

41. Mandibuloacral Dysplasia Type A in Childhood

Author

Garavelli, L., DʼApice, M. R., Rivieri, F., Bertoli, M., Wischmeijer, A., Gelmini, C., De Nigris, V., Albertini, E., Rosato, S., Virdis, R., Bacchini, E., Dal Zotto, R., Banchini, G., Iughetti, L., Bernasconi, S., Superti-Furga, A., and Novelli, G.

Published
2009
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42. Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke

Author

Vlastra, Wieneke, Jimenez-Quevedo, Pilar, Tchétché, Didier, Chandrasekhar, Jaya, de Brito, Fabio S, Barbanti, Marco, Kornowski, Ran, Latib, Azeem, D'Onofrio, Augusto, Ribichini, Flavio, Baan, Jan, Tijssen, Jan G P, De la Torre Hernandez, Jose M, Dumonteil, Nicolas, Sarmento-Leite, Rogério, Sartori, Samantha, Rosato, S, Tarantini, Giuseppe, Lunardi, Mattia, Orvin, Katia, Pagnesi, Matteo, Hernandez-Antolin, Rosana, Modine, Thomas, Dangas, George, Mehran, Roxana, Piek, Jan J, Delewi, Ronak, ACS - Pulmonary hypertension & thrombosis, ACS - Microcirculation, ACS - Atherosclerosis & ischemic syndromes, Graduate School, Cardiology, ACS - Amsterdam Cardiovascular Sciences, APH - Aging & Later Life, and ACS - Heart failure & arrhythmias

Subjects
Aged, 80 and over, Male, Clinical Trials as Topic, Time Factors, Incidence, Aortic Valve Stenosis, Punctures, Risk Assessment, follow-up studies, Femoral Artery, Stroke, Transcatheter Aortic Valve Replacement, Treatment Outcome, Risk Factors, humans, incidence, stroke, transcatheter aortic valve replacement, Aortic Valve, Catheterization, Peripheral, Humans, Female, Registries, Aged
Abstract

BACKGROUND: Stroke remains one of the most devastating complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to identify the incidence, timing, temporal trends, and predictors of stroke after TAVI and evaluate the outcomes of patients with stroke. METHODS AND RESULTS: The CENTER-Collaboration is an international collaboration consisting of 3 national registries and 7 local registries or prospective clinical trials, selected through a systematic review. Accordingly, a total of 10 982 patients undergoing transfemoral TAVI between 2007 and 2018 were included in the current patient-level pooled analyses. A total of 261 patients (2.4%) experienced stroke during the first month after TAVI. The median time between TAVI and stroke was 1 day (interquartile range, 0-6 days). The stroke rate was comparable in procedures performed in the early years of TAVI (2007-2012) to those in the more recent years of TAVI (2013-2018; both 2.4%; P=1.0). Independent predictors of stroke at 30 days were a history of cerebrovascular events (odds ratio, 2.2; 95% CI, 1.4-3.6; P=0.0012) and a glomerular filtration rate of

Published
2019

43. Five-Year Outcomes of Transfemoral Transcatheter Aortic Valve Replacement or Surgical Aortic Valve Replacement in a Real World Population: Final Results from the OBSERVANT Study

Author

Barbanti, M, Tamburino, C, D'Errigo, P, Biancari, F, Ranucci, M, Rosato, S, Santoro, G, Fusco, D, Seccareccia, F, Member of the Observant Research Group, Pisano, C, Ruvolo, G, and Nardi, P

Subjects
Aortic valve, medicine.medical_specialty, Transcatheter aortic, business.industry, medicine.medical_treatment, heart failure, medicine.disease, aortic valve, Stenosis, hospitalization, myocardial infarction, transcatheter aortic valve replacement, Settore MED/23, medicine.anatomical_structure, Aortic valve replacement, Valve replacement, Heart failure, Internal medicine, medicine, Cardiology, Myocardial infarction, Cardiology and Cardiovascular Medicine, business
Abstract

Background: The OBSERVANT study (Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study. Methods and Results: The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary end points of this analysis were death from any cause and major adverse cardiac and cerebrovascular events at 5 years. The matched population had a total of 1300 patients (650 per group). The propensity score method generated a low and intermediate-risk population (mean logistic EuroSCORE 2: 5.1±6.2% versus 4.9±5.1%, SAVR versus transfemoral TAVR; P =0.485). At 5 years, the rate of 5 death from any cause was 35.8% in the surgical group and 48.3% in the transcatheter group (hazard ratio, 1.38; 95% CI, 1.12–1.69; P =0.002). Similarly, TAVR was associated with an increased risk of major adverse cardiac and cerebrovascular events as compared with SAVR (42.5% versus 54.0%; hazard ratio, 1.35; 95% CI, 1.11–1.63; P =0.003). The cumulative incidence of cerebrovascular events, myocardial infarction, and coronary revascularization were similar in the study groups at 5 years. Conclusions: The present results suggest that at 5 years, in a real-world population with severe aortic stenosis and at low and intermediate risk, suggest that SAVR is associated in with lower mortality and major adverse cardiac and cerebrovascular events rates than transfemoral TAVR performed using first-generation devices. These data need to be confirmed in randomized trials using new-generation TAVR devices.

Published
2019

44. Performance of CHA2DS2-VASc score for stroke prediction after surgical aortic valve replacement

Author

Kiviniemi, T. (Tuomas), Lehto, J. (Joonas), Nissinen, M. (Maunu), Nieminen, T. (Tuomo), Hartikainen, J. (Juha), Malmberg, M. (Markus), Yannopoulos, F. (Fredrik), Savolainen, J. (Jyri), Karjalainen, P. (Pasi), Airaksinen, K. E. (K. E. Juhani), Rosato, S. (Stefano), and Biancari, F. (Fausto)

Subjects
cardiovascular surgery, transient ischemic attack, ischemic stroke, aortic valve replacement
Abstract

Objective: Stroke is a frequent complication occurring early and late after surgical aortic valve replacement. There is an unmet clinical need for simple tools to assess postoperative stroke risk. We sought to assess the predictive performance of Congestive heart failure; Hypertension; Age ≥75 (doubled); Diabetes mellitus; prior Stroke, transient ischemic attack or thromboembolism (doubled); Vascular disease; Age 65 to 74; Sex category (female) (CHA₂DS₂-VASc) score in patients undergoing surgical aortic valve replacement with a bioprosthesis. Methods: Seven hundred fourteen patients undergoing isolated surgical aortic valve replacement with a bioprosthesis at 4 university hospitals were included. Data were collected retrospectively from patient records and monitored by an independent party. Results: Median follow-up time was 4.8 years. Mean CHA₂DS₂-VASc score was 4.1 ± 1.6. Low (scores, 0–1), high (scores, 2–4), and very high (scores, 5–9) CHA₂DS₂-VASc scores were observed in 39 (5.5%), 400 (56.0%), and 262 (38.5%) patients, respectively. Incidences of stroke or transient ischemic attack at 1 year were 2.6%, 4.8%, and 10.7%; at 5 years incidences were 5.2%, 14.0%, and 21.9%; and at 10 years incidence were 5.2%, 20.7%, and 37.9% for patients in low, high, and very high scores, respectively. Incidences of major bleeds at 1 year were 0%, 1.8%, and 2.7%; at 5 years incidences were 0%, 5.4%, and 8.7%; and at 10 years incidences were 0%, 9.0%, and 27.1%, respectively. Competing risk analysis showed that patients with CHA₂DS₂-VASc score of 5 through 9 had a significantly increased risk of stroke or transient ischemic attack (hazard ratio, 4.75; 95% confidence interval, 1.09–20.6; P = .037) irrespective of preoperative or new-onset in-hospital atrial fibrillation compared with low-risk patients. Conclusions: CHA₂DS₂-VASc is a valuable tool to identify patients with increased risk of stroke and major bleeding, and for whom alternative strategies for prevention of late neurologic complications should be adopted.

Published
2019

45. Five-year outcomes of transfemoral transcatheter aortic valve replacement or surgical aortic valve replacement in a real world population final results from the OBSERVANT study

Author

Barbanti, M. (Marco), Tamburino, C. (Corrado), D’Errigo, P. (Paola), Biancari, F. (Fausto), Ranucci, M. (Marco), Rosato, S. (Stefano), Santoro, G. (Gennaro), Fusco, D. (Danilo), and Seccareccia, F. (Fulvia)

Subjects
mycardial infarction, heart failure, transcatheter aortic valve replacement, aortic valve, hospitalization
Abstract

Background: The OBSERVANT study (Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study. Methods and Results: The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary end points of this analysis were death from any cause and major adverse cardiac and cerebrovascular events at 5 years. The matched population had a total of 1300 patients (650 per group). The propensity score method generated a low and intermediate-risk population (mean logistic EuroSCORE 2: 5.1±6.2% versus 4.9±5.1%, SAVR versus transfemoral TAVR; P=0.485). At 5 years, the rate of 5 death from any cause was 35.8% in the surgical group and 48.3% in the transcatheter group (hazard ratio, 1.38; 95% CI, 1.12–1.69; P=0.002). Similarly, TAVR was associated with an increased risk of major adverse cardiac and cerebrovascular events as compared with SAVR (42.5% versus 54.0%; hazard ratio, 1.35; 95% CI, 1.11–1.63; P=0.003). The cumulative incidence of cerebrovascular events, myocardial infarction, and coronary revascularization were similar in the study groups at 5 years. Conclusions: The present results suggest that at 5 years, in a real-world population with severe aortic stenosis and at low and intermediate risk, suggest that SAVR is associated in with lower mortality and major adverse cardiac and cerebrovascular events rates than transfemoral TAVR performed using first-generation devices. These data need to be confirmed in randomized trials using new-generation TAVR devices.

Published
2019

46. Factors influencing the choice between transcatheter and surgical treatment of severe aortic stenosis in patients younger than 80 years: Results from the OBSERVANT study

Author

Tarantini, G, Nai Fovino, L, D'Errigo, P, Rosato, S, Barbanti, M, Tamburino, C, Ranucci, M, Santoro, G, Badoni, G, Seccareccia, F, Member of the Observant Research Group, Pisano, C, Ruvolo, G, and Nardi, P

Subjects
Male, medicine.medical_specialty, Health Status, Clinical Decision-Making, Comorbidity, 030204 cardiovascular system & hematology, Choice Behavior, Risk Assessment, Severity of Illness Index, Transcatheter Aortic Valve Replacement, TAVI, 03 medical and health sciences, 0302 clinical medicine, aortic stenosis, transcatheter heart valves, young, Aortic valve replacement, Risk Factors, Internal medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, Prospective Studies, 030212 general & internal medicine, Surgical treatment, Prospective cohort study, Aged, Heart Valve Prosthesis Implantation, business.industry, Patient Selection, Age Factors, Aortic Valve Stenosis, General Medicine, Odds ratio, Middle Aged, medicine.disease, Confidence interval, Cardiac surgery, Stenosis, Settore MED/23, Treatment Outcome, Italy, Aortic Valve, Female, Observational study, Cardiology and Cardiovascular Medicine, business
Abstract

OBJECTIVES We aimed to analyze the baseline features and clinical outcomes of patients younger than 80 years undergoing transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) real-world study, focusing on variables guiding Heart Team decision toward TAVI. BACKGROUND Patients treated with TAVI, independently of surgical risk score, are mostly older than 80 years. METHODS OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis (AS) who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. For this analysis, baseline characteristics, therapeutic approach and outcomes up to 5 years of follow-up of 4,801 patients under 80 years of age were collected. Patients were stratified by age classes (

Published
2019

47. Impact of preoperative thrombocytopenia on the outcome after coronary artery bypass grafting

Author

Nammas, W. (Wail), Dalén, M. (Magnus), Rosato, S. (Stefano), Gherli, R. (Riccardo), Reichart, D. (Daniel), Gatti, G. (Giuseppe), Onorati, F. (Francesco), Faggian, G. (Giuseppe), De Feo, M. (Marisa), Bancone, C. (Ciro), Chocron, S. (Sidney), Khodabandeh, S. (Sorosh), Santarpino, G. (Giuseppe), Rubino, A. S. (Antonino S.), Maselli, D. (Daniele), Nardella, S. (Saverio), Salsano, A. (Antonio), Gherli, T. (Tiziano), Nicolini, F. (Francesco), Zanobini, M. (Marco), Saccocci, M. (Matteo), Bounader, K. (Karl), D’Errigo, P. (Paola), Kiviniemi, T. (Tuomas), Kinnunen, E.-M. (Eeva-Maija), Perrotti, A. (Andrea), Airaksinen, J. (Juhani), Mariscalco, G. (Giovanni), Ruggieri, V. G. (Vito G.), Biancari, F. (Fausto), Nammas, W. (Wail), Dalén, M. (Magnus), Rosato, S. (Stefano), Gherli, R. (Riccardo), Reichart, D. (Daniel), Gatti, G. (Giuseppe), Onorati, F. (Francesco), Faggian, G. (Giuseppe), De Feo, M. (Marisa), Bancone, C. (Ciro), Chocron, S. (Sidney), Khodabandeh, S. (Sorosh), Santarpino, G. (Giuseppe), Rubino, A. S. (Antonino S.), Maselli, D. (Daniele), Nardella, S. (Saverio), Salsano, A. (Antonio), Gherli, T. (Tiziano), Nicolini, F. (Francesco), Zanobini, M. (Marco), Saccocci, M. (Matteo), Bounader, K. (Karl), D’Errigo, P. (Paola), Kiviniemi, T. (Tuomas), Kinnunen, E.-M. (Eeva-Maija), Perrotti, A. (Andrea), Airaksinen, J. (Juhani), Mariscalco, G. (Giovanni), Ruggieri, V. G. (Vito G.), and Biancari, F. (Fausto)

Abstract

The impact of thrombocytopenia on postoperative bleeding and other major adverse events after cardiac surgery is unclear. This issue was investigated in a series of patients who underwent isolated coronary artery bypass grafting (CABG) from the prospective, multicenter E-CABG registry. Preoperative thrombocytopenia was defined as preoperative platelet count <150 × 10⁹/L and it was considered moderate-severe when preoperative platelet count was <100 × 10⁹/L. Multilevel mixed-effects regression analysis was performed to adjust the effect of thrombocytopenia on outcomes for baseline and operative covariates as well as for interinstitutional differences in patient-blood management. Among 7189 patients included in this analysis, 599 (8.3%) had preoperative thrombocytopenia. Patient with preoperative thrombocytopenia had an increased chest drainage output at 12 h (mean, 519 vs. 456 mL, adjusted coeff. 39, 95%CI 18–60) and rates of severe-massive bleeding (Universal Definition of Perioperative Bleeding (UDPB) severity grades 3–4: 12.7% vs. 8.1%, adjusted OR 1.47, 95%CI 1.11–1.93; E-CABG bleeding severity grades 2–3: 10.4% vs. 6.1%, adjusted OR 1.78, 95%CI 1.30–2.43). Thrombocytopenia was associated with an increased risk of hospital/30-day death (3.2% vs. 1.9%, adjusted OR 2.02, 95%CI 1.20–3.42), 1-year death (5.7% vs. 3.4%, adjusted HR 1.68, 95%CI 1.16–2.44), deep sternal wound infection (3.5% vs. 2.4%, adjusted OR 1.65, 95%CI 1.02–2.66), acute kidney injury (28.1% vs. 22.2%, OR 1.45, 1.18–1.78), and prolonged stay in the intensive care unit (mean, 3.6 vs 2.8 days, adjusted coeff. 0.74, 95%CI 0.40–1.09). Similar results were observed in a subset of patients with moderate-severe thrombocytopenia (51 patients, 0.7%). In particular, these patients had a markedly higher rate of acute kidney injury (40%, adjusted OR, 1.94, 95%CI 1.05–3.57), resternotomy for bleeding (7.8%, adjusted OR 3.49, 95%CI 1.20–10.21), and severe-massive bleeding (UDPB severity grades 3–4

Published
2019

48. Bleeding in patients treated with ticagrelor or clopidogrel before coronary artery bypass grafting

Author

Holm, M. (Manne), Biancari, F. (Fausto), Khodabandeh, S. (Sorosh), Gherli, R. (Riccardo), Airaksinen, J. (Juhani), Mariscalco, G. (Giovanni), Gatti, G. (Giuseppe), Reichart, D. (Daniel), Onorati, F. (Francesco), De Feo, M. (Marisa), Santarpino, G. (Giuseppe), Rubino, A. S. (Antonino S.), Maselli, D. (Daniele), Santini, F. (Francesco), Nicolini, F. (Francesco), Zanobini, M. (Marco), Kinnunen, E.-M. (Eeva-Maija), Ruggieri, V. G. (Vito G.), Perrotti, A. (Andrea), Rosato, S. (Stefano), Dalén, M. (Magnus), Holm, M. (Manne), Biancari, F. (Fausto), Khodabandeh, S. (Sorosh), Gherli, R. (Riccardo), Airaksinen, J. (Juhani), Mariscalco, G. (Giovanni), Gatti, G. (Giuseppe), Reichart, D. (Daniel), Onorati, F. (Francesco), De Feo, M. (Marisa), Santarpino, G. (Giuseppe), Rubino, A. S. (Antonino S.), Maselli, D. (Daniele), Santini, F. (Francesco), Nicolini, F. (Francesco), Zanobini, M. (Marco), Kinnunen, E.-M. (Eeva-Maija), Ruggieri, V. G. (Vito G.), Perrotti, A. (Andrea), Rosato, S. (Stefano), and Dalén, M. (Magnus)

Abstract

Background: We evaluated perioperative bleeding after coronary artery bypass grafting (CABG) in patients preoperatively treated with ticagrelor or clopidogrel, stratified by discontinuation of these P2Y₁₂ inhibitors. Methods: All patients from the prospective, European Multicenter Registry on Coronary Artery Bypass Grafting (E-CABG) treated with ticagrelor or clopidogrel undergoing isolated primary CABG were eligible. The primary outcome measure was severe or massive bleeding defined according to the Universal Definition of Perioperative Bleeding, stratified by P2Y₁₂ inhibitor discontinuation. Secondary outcome measures included four additional definitions of major bleeding. Propensity score matching was performed to adjust for differences in preoperative and perioperative covariates. Results: Of 2,311 patients who were included, 1,293 (55.9%) received clopidogrel and 1,018 (44.1%) ticagrelor preoperatively. Mean time between discontinuation and the operation was 4.5 ± 3.2 days for clopidogrel and 4.9 ± 3.0 days for ticagrelor. In the propensity score–matched cohort, ticagrelor-treated patients had a higher incidence of major bleeding according to Universal Definition of Perioperative Bleeding when ticagrelor was discontinued 0 to 2 days compared with 3 days before the operation (16.0% vs 2.7%, p = 0.003). Clopidogrel-treated patients had a higher incidence of major bleeding according to the Universal Definition of Perioperative Bleeding when clopidogrel was discontinued 0 to 3 days compared with 4 to 5 days before the operation (15.6% vs 8.3%, p = 0.031). Conclusions: In patients receiving ticagrelor 2 days before CABG and in those receiving clopidogrel 3 days before CABG, there was an increased rate of severe bleeding. Postponing nonemergent CABG for at least 3 days after discontinuation of ticagrelor and 4 days after clopidogrel should be considered.

Published
2019

49. Comparison of outcomes after transcatheter aortic valve replacement vs surgical aortic valve replacement among patients with aortic stenosis at low operative risk

Author

Virtanen, M. P. (Marko P. O.), Eskola, M. (Markku), Jalava, M. P. (Maina P.), Husso, A. (Annastiina), Laakso, T. (Teemu), Niemelä, M. (Matti), Ahvenvaara, T. (Tuomas), Tauriainen, T. (Tuomas), Maaranen, P. (Pasi), Kinnunen, E.-M. (Eeva-Maija), Dahlbacka, S. (Sebastian), Jaakkola, J. (Jussi), Vasankari, T. (Tuija), Airaksinen, J. (Juhani), Anttila, V. (Vesa), Rosato, S. (Stefano), D’Errigo, P. (Paola), Savontaus, M. (Mikko), Juvonen, T. (Tatu), Laine, M. (Mika), Mäkikallio, T. (Timo), Valtola, A. (Antti), Raivio, P. (Peter), Biancari, F. (Fausto), Virtanen, M. P. (Marko P. O.), Eskola, M. (Markku), Jalava, M. P. (Maina P.), Husso, A. (Annastiina), Laakso, T. (Teemu), Niemelä, M. (Matti), Ahvenvaara, T. (Tuomas), Tauriainen, T. (Tuomas), Maaranen, P. (Pasi), Kinnunen, E.-M. (Eeva-Maija), Dahlbacka, S. (Sebastian), Jaakkola, J. (Jussi), Vasankari, T. (Tuija), Airaksinen, J. (Juhani), Anttila, V. (Vesa), Rosato, S. (Stefano), D’Errigo, P. (Paola), Savontaus, M. (Mikko), Juvonen, T. (Tatu), Laine, M. (Mika), Mäkikallio, T. (Timo), Valtola, A. (Antti), Raivio, P. (Peter), and Biancari, F. (Fausto)

Abstract

Importance: Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce. Objective: To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS. Design, Setting, and Participants: This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts. Exposures: Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization. Main Outcomes and Measures: The primary outcomes were 30-day and 3-year survival. Results: Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who r

Published
2019

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

Author

Kondili, La, Romano, F, Rolli, Fr, Ruggeri, M, Rosato, S, Brunetto, Mr, Zignego, Al, Ciancio, A, Di Leo, A, Raimondo, G, Ferrari, C, Taliani, G, Borgia, G, Santantonio, Ta, Blanc, P, Gaeta, Gb, Gasbarrini, A, Chessa, L, Erne, Em, Villa, E, Ieluzzi, D, Russo, Fp, Andreone, P, Vinci, M, Coppola, C, Chemello, L, Madonia, S, Verucchi, G, Persico, M, Zuin, M, Puoti, M, Alberti, A, Nardone, G, Massari, M, Montalto, G, Foti, G, Rumi, Mg, Quaranta, Mg, Cicchetti, A, Craxì, A, Vella, S, PITER Collaborating Group, Kondili, Loreta A., Romano, Federica, Rolli, Francesca Romana, Ruggeri, Matteo, Rosato, Stefano, Brunetto, Maurizia Rossana, Zignego, Anna Linda, Ciancio, Alessia, Di Leo, Alfredo, Raimondo, Giovanni, Ferrari, Carlo, Taliani, Gloria, Borgia, Guglielmo, Santantonio, Teresa Antonia, Blanc, Pierluigi, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Chessa, Luchino, Erne, Elke Maria, Villa, Erica, Ieluzzi, Donatella, Russo, Francesco Paolo, Andreone, Pietro, Vinci, Maria, Coppola, Carmine, Chemello, Liliana, Madonia, Salvatore, Verucchi, Gabriella, Persico, Marcello, Zuin, Massimo, Puoti, Massimo, Alberti, Alfredo, Nardone, Gerardo, Massari, Marco, Montalto, Giuseppe, Foti, Giuseppe, Rumi, Maria Grazia, Quaranta, Maria Giovanna, Cicchetti, Americo, Craxì, Antonio, Vella, Stefano, Kondili, L, Romano, F, Rolli, F, Ruggeri, M, Rosato, S, Brunetto, M, Zignego, A, Ciancio, A, Di Leo, A, Raimondo, G, Ferrari, C, Taliani, G, Borgia, G, Santantonio, T, Blanc, P, Gaeta, G, Gasbarrini, A, Chessa, L, Erne, E, Villa, E, Ieluzzi, D, Russo, F, Andreone, P, Vinci, M, Coppola, C, Chemello, L, Madonia, S, Verucchi, G, Persico, M, Zuin, M, Puoti, M, Alberti, A, Nardone, G, Massari, M, Montalto, G, Foti, G, Rumi, M, Quaranta, M, Cicchetti, A, Craxì, A, Vella, S, Kondili LA1, Romano F2, Rolli FR2, Ruggeri M2, Rosato S1, Brunetto MR3, Zignego AL4, Ciancio A5, Di Leo A6, Raimondo G7, Ferrari C8, Taliani G9, Borgia G10, Santantonio TA11, Blanc P12, Gaeta GB13, Gasbarrini A2, Chessa L14, Erne EM15, Villa E16, Ieluzzi D17, Russo FP15, Andreone P18, Vinci M19, Coppola C20, Chemello L15, Madonia S21, Verucchi G18, Persico M22, Zuin M23, Puoti M19, Alberti A15, Nardone G13, Massari M24, Montalto G25, Foti G26, Rumi MG23, Quaranta MG1, Cicchetti A2, Craxì Antonio, Vella S1, and PITER Collaborating Group.

Subjects
hepatitis C virus, Pediatrics, Cost effectiveness, Viral Hepatitis, Adult, Aged, Aged, 80 and over, Antiviral Agents, Cohort Studies, Cost-Benefit Analysis, Health Policy, Hepatitis C, Humans, Middle Aged, Young Adult, Models, Economic, Hepatology, Direct-acting antiviral, Liver disease, 0302 clinical medicine, Models, Health care, antiviral therapy, 80 and over, incremental cost-effectiveness ratio, health care economics and organizations, HCV cost -effectiveness, Direct-acting antiviral, hepatocellular carcinoma, hepatitis C virus, incremental cost-effectiveness ratio, interferon, quality-adjusted life-years, sustained virological response, willingness to pay, Cost–benefit analysis, 030503 health policy & services, quality-adjusted life-years, hepatocellular carcinoma, interferon, HCV, cost-effectiveness, real-life cohort, Cohort, 030211 gastroenterology & hepatology, Original Article, sustained virological response, 0305 other medical science, Cohort study, Human, medicine.medical_specialty, Economic, NO, 03 medical and health sciences, medicine, Cost-Benefit Analysi, Health policy, Antiviral Agent, business.industry, Original Articles, medicine.disease, Surgery, Cohort Studie, business, willingness to pay
Abstract

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).

Published
2017

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