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2. Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention

Author

Baldassarre, D, Iacoviello, L, Baetta, R, Roncaglioni, M, Condorelli, G, Remuzzi, G, Gensini, G, Frati, L, Ricciardi, W, Conaldi, P, Uccelli, A, Blandini, F, Bosari, S, Scambia, G, Fini, M, Di Malta, A, Amato, M, Veglia, F, Bonomi, A, Klersy, C, Colazzo, F, Pengo, M, Gorini, F, Auteri, L, Ferrante, G, Baviera, M, Ambrosio, G, Catapano, A, Gialluisi, A, Malavazos, A, Castelvecchio, S, Corsi-Romanelli, M, Cardani, R, La Rovere, M, Agnese, V, Pane, B, Prati, D, Spinardi, L, Liuzzo, G, Arbustini, E, Volterrani, M, Visconti, M, Werba, J, Genovese, S, Bilo, G, Invitti, C, Di Blasio, A, Lombardi, C, Faini, A, Rosa, D, Ojeda-Fernandez, L, Foresta, A, De Curtis, A, Di Castelnuovo, A, Scalvini, S, Pierobon, A, Gorini, A, Valenti, L, Luzi, L, Racca, A, Bandi, M, Tremoli, E, Menicanti, L, Parati, G, Pompilio, G, Colombo, G, Vavassori, C, Biondi, M, Frigerio, B, Ravani, A, Sansaro, D, Coggi, D, Romandini, A, Giroli, M, Giuliani, M, Bonmi, A, Rondinelli, M, Trudu, C, Cinieri, C, Monturano, M, Colazo, F, Inviti, C, Di Blasi, A, Torlasco, C, Gilardini, L, Soranna, D, Zambon, A, Perger, E, Zanotti, L, Badano, L, Cova, L, Gentilini, D, Grappiolo, L, Condoreli, G, Ferante, G, Papa, L, Savevski, V, Ieva, F, Romano, I, Remzzi, G, Ojeda, L, Clerici, F, Palumbo, A, Genini, G, Catpano, A, Mattioli, R, Longhi, E, Mantovani, L, Madotto, F, Bonaccio, M, Gianfagna, F, Ghulam, A, Magnacca, S, Noro, F, Costanzo, S, Esposito, S, Orlandi, S, Persichillo, M, Bracone, F, Panzera, T, Ruggiero, E, Parisi, R, Franciosa, S, Morelli, M, De Rita, F, Cerletti, C, de Gaetano, G, Donati, M, Mencanti, L, Romanelli, M, Cerri, A, Dubini, C, Trevisan, M, Renna, L, Milani, V, Boveri, S, Giubbilini, P, Ramputi, L, Baroni, I, De Angeli, G, Riciardi, W, Olmetti, F, Bussotti, M, Gaetano, C, Baiardi, P, Bachetti, T, Balbi, M, Comini, L, Lorenzoni, M, Olivares, A, Traversi, E, Garre, C, Sideri, R, Clemenza, F, Gentile, G, Caruana, G, Cuscino, N, Di Gesaro, G, Greco, A, Loddo, I, Tuzzolino, F, Ucelli, A, Palombo, D, Spinella, G, Mozzetta, G, Ameri, P, Zoppoli, G, Finotello, A, Porto, I, Pratesi, G, Bladini, F, Spnardi, L, Clerici, M, Pelusi, S, Bianco, C, Carpani, R, Periti, G, Margarita, S, Lanza, G, Severino, A, Pedicino, D, D'Amario, D, D'Aiello, A, Vinci, R, Bonanni, A, Brecciaroli, M, Filomia, S, Pastorino, R, Boccia, S, Urbani, A, Sanguinetti, M, Santoliquido, A, Proto, L, Tarquini, D, Grimaldi, M, Leonardi, S, Elia, A, Currao, A, Urtis, M, Di Toro, A, Giuliani, L, Caminiti, G, Marcolongo, F, Sposato, B, Guadagni, F, Morsella, V, Marziale, A, Protti, G, Baldassarre D., Iacoviello L., Baetta R., Roncaglioni M. C., Condorelli G., Remuzzi G., Gensini G., Frati L., Ricciardi W., Conaldi P. G., Uccelli A., Blandini F., Bosari S., Scambia G., Fini M., Di Malta A., Amato M., Veglia F., Bonomi A., Klersy C., Colazzo F., Pengo M., Gorini F., Auteri L., Ferrante G., Baviera M., Ambrosio G., Catapano A., Gialluisi A., Malavazos A. E., Castelvecchio S., Corsi-Romanelli M. M., Cardani R., La Rovere M. T., Agnese V., Pane B., Prati D., Spinardi L., Liuzzo G., Arbustini E., Volterrani M., Visconti M., Werba J. P., Genovese S., Bilo G., Invitti C., Di Blasio A., Lombardi C., Faini A., Rosa D., Ojeda-Fernandez L., Foresta A., De Curtis A., Di Castelnuovo A., Scalvini S., Pierobon A., Gorini A., Valenti L., Luzi L., Racca A., Bandi M., Tremoli E., Menicanti L., Parati G., Pompilio G., Colombo G., Vavassori C., Biondi M. L., Frigerio B., Ravani A., Sansaro D., Coggi D., Romandini A., Giroli M., Giuliani M., Bonmi A., Rondinelli M., Trudu C., Cinieri C., Monturano M., Colazo F., Inviti C., Di Blasi A., Torlasco C., Gilardini L., Soranna D., Zambon A., Perger E., Zanotti L., Badano L., Cova L., Gentilini D., Grappiolo L., Condoreli G., Ferante G., Papa L., Savevski V., Ieva F., Romano I., Remzzi G., Ojeda L., Clerici F., Palumbo A., Genini G. F., Catpano A., Mattioli R., Longhi E., Mantovani L. G., Madotto F., Bonaccio M., Gianfagna F., Ghulam A., Magnacca S., Noro F., Costanzo S., Esposito S., Orlandi S., Persichillo M., Bracone F., Panzera T., Ruggiero E., Parisi R., Franciosa S., Morelli M., De Rita F., Cerletti C., de Gaetano G., Donati M. B., Mencanti L., Romanelli M. M. C., Cerri A., Dubini C., Trevisan M. B., Renna L. V., Milani V., Boveri S., Giubbilini P., Ramputi L., Baroni I., De Angeli G., Riciardi W., Olmetti F., Bussotti M., Gaetano C., Baiardi P., Bachetti T., Balbi M., Comini L., Lorenzoni M., Olivares A., Traversi E., Garre C., Sideri R., Clemenza F., Gentile G., Caruana G., Cuscino N., Di Gesaro G., Greco A., Loddo I., Tuzzolino F., Ucelli A., Palombo D., Spinella G., Mozzetta G., Ameri P., Zoppoli G., Finotello A., Porto I., Pratesi G., Bladini F., Spnardi L., Clerici M., Pelusi S., Bianco C., Carpani R., Periti G., Margarita S., Lanza G. A., Severino A., Pedicino D., D'Amario D., D'Aiello A., Vinci R., Bonanni A., Brecciaroli M., Filomia S., Pastorino R., Boccia S., Urbani A., Sanguinetti M., Santoliquido A., Proto L., Tarquini D., Grimaldi M. C., Leonardi S., Elia A., Currao A., Urtis M., Di Toro A., Giuliani L., Caminiti G., Marcolongo F., Sposato B., Guadagni F., Morsella V., Marziale A., Protti G., Baldassarre, D, Iacoviello, L, Baetta, R, Roncaglioni, M, Condorelli, G, Remuzzi, G, Gensini, G, Frati, L, Ricciardi, W, Conaldi, P, Uccelli, A, Blandini, F, Bosari, S, Scambia, G, Fini, M, Di Malta, A, Amato, M, Veglia, F, Bonomi, A, Klersy, C, Colazzo, F, Pengo, M, Gorini, F, Auteri, L, Ferrante, G, Baviera, M, Ambrosio, G, Catapano, A, Gialluisi, A, Malavazos, A, Castelvecchio, S, Corsi-Romanelli, M, Cardani, R, La Rovere, M, Agnese, V, Pane, B, Prati, D, Spinardi, L, Liuzzo, G, Arbustini, E, Volterrani, M, Visconti, M, Werba, J, Genovese, S, Bilo, G, Invitti, C, Di Blasio, A, Lombardi, C, Faini, A, Rosa, D, Ojeda-Fernandez, L, Foresta, A, De Curtis, A, Di Castelnuovo, A, Scalvini, S, Pierobon, A, Gorini, A, Valenti, L, Luzi, L, Racca, A, Bandi, M, Tremoli, E, Menicanti, L, Parati, G, Pompilio, G, Colombo, G, Vavassori, C, Biondi, M, Frigerio, B, Ravani, A, Sansaro, D, Coggi, D, Romandini, A, Giroli, M, Giuliani, M, Bonmi, A, Rondinelli, M, Trudu, C, Cinieri, C, Monturano, M, Colazo, F, Inviti, C, Di Blasi, A, Torlasco, C, Gilardini, L, Soranna, D, Zambon, A, Perger, E, Zanotti, L, Badano, L, Cova, L, Gentilini, D, Grappiolo, L, Condoreli, G, Ferante, G, Papa, L, Savevski, V, Ieva, F, Romano, I, Remzzi, G, Ojeda, L, Clerici, F, Palumbo, A, Genini, G, Catpano, A, Mattioli, R, Longhi, E, Mantovani, L, Madotto, F, Bonaccio, M, Gianfagna, F, Ghulam, A, Magnacca, S, Noro, F, Costanzo, S, Esposito, S, Orlandi, S, Persichillo, M, Bracone, F, Panzera, T, Ruggiero, E, Parisi, R, Franciosa, S, Morelli, M, De Rita, F, Cerletti, C, de Gaetano, G, Donati, M, Mencanti, L, Romanelli, M, Cerri, A, Dubini, C, Trevisan, M, Renna, L, Milani, V, Boveri, S, Giubbilini, P, Ramputi, L, Baroni, I, De Angeli, G, Riciardi, W, Olmetti, F, Bussotti, M, Gaetano, C, Baiardi, P, Bachetti, T, Balbi, M, Comini, L, Lorenzoni, M, Olivares, A, Traversi, E, Garre, C, Sideri, R, Clemenza, F, Gentile, G, Caruana, G, Cuscino, N, Di Gesaro, G, Greco, A, Loddo, I, Tuzzolino, F, Ucelli, A, Palombo, D, Spinella, G, Mozzetta, G, Ameri, P, Zoppoli, G, Finotello, A, Porto, I, Pratesi, G, Bladini, F, Spnardi, L, Clerici, M, Pelusi, S, Bianco, C, Carpani, R, Periti, G, Margarita, S, Lanza, G, Severino, A, Pedicino, D, D'Amario, D, D'Aiello, A, Vinci, R, Bonanni, A, Brecciaroli, M, Filomia, S, Pastorino, R, Boccia, S, Urbani, A, Sanguinetti, M, Santoliquido, A, Proto, L, Tarquini, D, Grimaldi, M, Leonardi, S, Elia, A, Currao, A, Urtis, M, Di Toro, A, Giuliani, L, Caminiti, G, Marcolongo, F, Sposato, B, Guadagni, F, Morsella, V, Marziale, A, Protti, G, Baldassarre D., Iacoviello L., Baetta R., Roncaglioni M. C., Condorelli G., Remuzzi G., Gensini G., Frati L., Ricciardi W., Conaldi P. G., Uccelli A., Blandini F., Bosari S., Scambia G., Fini M., Di Malta A., Amato M., Veglia F., Bonomi A., Klersy C., Colazzo F., Pengo M., Gorini F., Auteri L., Ferrante G., Baviera M., Ambrosio G., Catapano A., Gialluisi A., Malavazos A. E., Castelvecchio S., Corsi-Romanelli M. M., Cardani R., La Rovere M. T., Agnese V., Pane B., Prati D., Spinardi L., Liuzzo G., Arbustini E., Volterrani M., Visconti M., Werba J. P., Genovese S., Bilo G., Invitti C., Di Blasio A., Lombardi C., Faini A., Rosa D., Ojeda-Fernandez L., Foresta A., De Curtis A., Di Castelnuovo A., Scalvini S., Pierobon A., Gorini A., Valenti L., Luzi L., Racca A., Bandi M., Tremoli E., Menicanti L., Parati G., Pompilio G., Colombo G., Vavassori C., Biondi M. L., Frigerio B., Ravani A., Sansaro D., Coggi D., Romandini A., Giroli M., Giuliani M., Bonmi A., Rondinelli M., Trudu C., Cinieri C., Monturano M., Colazo F., Inviti C., Di Blasi A., Torlasco C., Gilardini L., Soranna D., Zambon A., Perger E., Zanotti L., Badano L., Cova L., Gentilini D., Grappiolo L., Condoreli G., Ferante G., Papa L., Savevski V., Ieva F., Romano I., Remzzi G., Ojeda L., Clerici F., Palumbo A., Genini G. F., Catpano A., Mattioli R., Longhi E., Mantovani L. G., Madotto F., Bonaccio M., Gianfagna F., Ghulam A., Magnacca S., Noro F., Costanzo S., Esposito S., Orlandi S., Persichillo M., Bracone F., Panzera T., Ruggiero E., Parisi R., Franciosa S., Morelli M., De Rita F., Cerletti C., de Gaetano G., Donati M. B., Mencanti L., Romanelli M. M. C., Cerri A., Dubini C., Trevisan M. B., Renna L. V., Milani V., Boveri S., Giubbilini P., Ramputi L., Baroni I., De Angeli G., Riciardi W., Olmetti F., Bussotti M., Gaetano C., Baiardi P., Bachetti T., Balbi M., Comini L., Lorenzoni M., Olivares A., Traversi E., Garre C., Sideri R., Clemenza F., Gentile G., Caruana G., Cuscino N., Di Gesaro G., Greco A., Loddo I., Tuzzolino F., Ucelli A., Palombo D., Spinella G., Mozzetta G., Ameri P., Zoppoli G., Finotello A., Porto I., Pratesi G., Bladini F., Spnardi L., Clerici M., Pelusi S., Bianco C., Carpani R., Periti G., Margarita S., Lanza G. A., Severino A., Pedicino D., D'Amario D., D'Aiello A., Vinci R., Bonanni A., Brecciaroli M., Filomia S., Pastorino R., Boccia S., Urbani A., Sanguinetti M., Santoliquido A., Proto L., Tarquini D., Grimaldi M. C., Leonardi S., Elia A., Currao A., Urtis M., Di Toro A., Giuliani L., Caminiti G., Marcolongo F., Sposato B., Guadagni F., Morsella V., Marziale A., and Protti G.

Abstract

Introduction Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking. Methods and analysis The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners' offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed. Ethics and dissemination This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study's

Published
2023

6. Ficolin-2 serum levels predict the occurrence of acute coronary syndrome in patients with severe carotid artery stenosis

Author

Carbone, F, Valente, A, Perego, C, Bertolotto, M, Pane, B, Spinella, G, Palombo, D, De Simoni, M, Montecucco, F, Fumagalli, S, Carbone F., Valente A., Perego C., Bertolotto M., Pane B., Spinella G., Palombo D., De Simoni M. -G., Montecucco F., Fumagalli S., Carbone, F, Valente, A, Perego, C, Bertolotto, M, Pane, B, Spinella, G, Palombo, D, De Simoni, M, Montecucco, F, Fumagalli, S, Carbone F., Valente A., Perego C., Bertolotto M., Pane B., Spinella G., Palombo D., De Simoni M. -G., Montecucco F., and Fumagalli S.

Abstract

Background and purpose: erosion of vulnerable atherosclerotic plaques may cause life-threatening thromboembolic complications. There is indeed an urgent need to recognize a clear-cut biomarker able to identify vulnerable plaques. Here, we focused on circulating proteins belonging to the lectin pathway (LP) of complement activation. Methods: we analyzed mannose-binding lectin (MBL), ficolin-1, -2 and -3 (LP initiators) levels by ELISA in sera from n = 240 of an already published cohort of patients undergoing endarterectomy for severe carotid stenosis and followed-up until 18 months after surgery. Immunofluorescence followed by confocal and polarized light microscopy was used to detect LP initiator intraplaque localization. Spearman's rank test was drawn to investigate correlation between serum LP levels and circulating inflammatory proteins or intraplaque components. Survival analyses were then performed to test the predictive role of LP on long-term adverse outcome. Results: ficolins, but not MBL, correlated positively with 1) high circulating levels of inflammatory markers, including MPO, MMP-8, MMP-9, ICAM-1, osteopontin, neutrophil elastase, and; 2) immune cell intraplaque recruitment. Immunofluorescence showed ficolins in calcified plaques and ficolin-2 in cholesterol-enriched plaque regions in association with macrophages. In the multivariate survival analysis, ficolin-2 serum levels predicted a major adverse cardiovascular event during the follow-up, independently of symptomatic status and inflammatory markers (hazard ratio 38.6 [95 % CI 3.9–385.2]). Conclusions: ficolins support intraplaque immune cell recruitment and inflammatory processes ultimately leading to plaque vulnerability. Especially for ficolin-2 a strong predictive value toward adverse cardiovascular events was demonstrated. This evidence offers potentially new pharmacological target to dampen the inflammatory mechanisms leading to plaque vulnerability.

Published
2021

9. The critical view of safety during laparoscopic cholecystectomy: Strasberg Yes or No? An Italian Multicentre study

Author

Sgaramella, L. I., Gurrado, A., Pasculli, A., de Angelis, N., Memeo, R., Prete, F. P., Berti, S., Ceccarelli, G., Rigamonti, M., Badessi, F. G. A., Solari, N., Milone, M., Catena, F., Scabini, S., Vittore, F., Perrone, G., de Werra, C., Cafiero, F., Testini, M., Baiocchi, G. L., Baldazzi, G., Battocletti, M., Bertoglio, S., Bianco, P., Bugiantella, W., Ciaccio, G., Cobianchi, L., Conzo, G., Crespi, M., De Rosa, M., Di Meo, G., Docimo, L., Fabris, L., Feleppa, C., Ferraro, V., Fontana, T., Gambardella, C., Gennai, A., Guida, F., Invernizzi, L., Massobrio, A., Medas, F., Monaco, L., Muntoni, G., Musella, M., Palombo, D., Perinotti, R., Pertile, D., Pezzolla, A., Piccirillo, G., Polastri, R., Ruggiero, R., Scatizzi, M., Somaglino, C., Tolone, S., Traverso, E., Tutino, R., Valduga, C., Zuolo, M., Sgaramella, L. I., Gurrado, A., Pasculli, A., de Angelis, N., Memeo, R., Prete, F. P., Berti, S., Ceccarelli, G., Rigamonti, M., Badessi, F. G. A., Solari, N., Milone, M., Catena, F., Scabini, S., Vittore, F., Perrone, G., de Werra, C., Cafiero, F., Testini, M., Baiocchi, G. L., Baldazzi, G., Battocletti, M., Bertoglio, S., Bianco, P., Bugiantella, W., Ciaccio, G., Cobianchi, L., Conzo, G., Crespi, M., De Rosa, M., Di Meo, G., Docimo, L., Fabris, L., Feleppa, C., Ferraro, V., Fontana, T., Gambardella, C., Gennai, A., Guida, F., Invernizzi, L., Massobrio, A., Medas, F., Monaco, L., Muntoni, G., Musella, M., Palombo, D., Perinotti, R., Pertile, D., Pezzolla, A., Piccirillo, G., Polastri, R., Ruggiero, R., Scatizzi, M., Somaglino, C., Tolone, S., Traverso, E., Tutino, R., Valduga, C., Zuolo, M., Sgaramella L.I., Gurrado A., Pasculli A., de Angelis N., Memeo R., Prete F.P., Berti S., Ceccarelli G., Rigamonti M., Badessi F.G.A., Solari N., Milone M., Catena F., Scabini S., Vittore F., Perrone G., de Werra C., Cafiero F., Testini M., Baiocchi G.L., Baldazzi G., Battocletti M., Bertoglio S., Bianco P., Bugiantella W., Ciaccio G., Cobianchi L., Conzo G., Crespi M., De Rosa M., Di Meo G., Docimo L., Fabris L., Feleppa C., Ferraro V., Fontana T., Gambardella C., Gennai A., Guida F., Invernizzi L., Massobrio A., Medas F., Monaco L., Muntoni G., Musella M., Palombo D., Perinotti R., Pertile D., Pezzolla A., Piccirillo G., Polastri R., Ruggiero R., Scatizzi M., Somaglino C., Tolone S., Traverso E., Tutino R., Valduga C., and Zuolo M.

Subjects
medicine.medical_specialty, Critical view of safety, medicine.medical_treatment, Laparoscopic training, bBile duct injuries, Bile duct injuries, Cholecystectomy, Intraoperative bleeding, Laparoscopy, Bile Duct Diseases, Article, cholecystectomy, critical view of safety, intraoperative bleeding, laparoscopic training, laparoscopy, Medicine, Humans, Intraoperative Complications, medicine.diagnostic_test, business.industry, Bile duct, General surgery, Gallbladder, Incidence (epidemiology), Gold standard, Perioperative, medicine.anatomical_structure, Cholecystectomy, Laparoscopic, Italy, Surgery, Bile Ducts, business, Bile duct injurie, Abdominal surgery
Abstract

Background Laparoscopic cholecystectomy is considered the gold standard for the treatment of gallbladder lithiasis; nevertheless, the incidence of bile duct injuries (BDI) is still high (0.3–0.8%) compared to open cholecystectomy (0.2%). In 1995, Strasberg introduced the "Critical View of Safety" (CVS) to reduce the risk of BDI. Despite its widespread use, the scientific evidence supporting this technique to prevent BDI is controversial. Methods Between March 2017 and March 2019, the data of patients submitted to laparoscopic cholecystectomy in 30 Italian surgical departments were collected on a national database. A survey was submitted to all members of Italian Digestive Pathology Society to obtain data on the preoperative workup, the surgical and postoperative management of patients and to judge, at the end of the procedure, if the isolation of the elements was performed according to the CVS. In the case of a declared critical view, iconographic documentation was obtained, finally reviewed by an external auditor. Results Data from 604 patients were analysed. The study population was divided into two groups according to the evidence (Group A; n = 11) or absence (Group B; N = 593) of BDI and perioperative bleeding. The non-use of CVS was found in 54.6% of procedures in the Group A, and 25.8% in the Group B, and evaluating the operator-related variables the execution of CVS was associated with a significantly lower incidence of BDI and intraoperative bleeding. Conclusions The CVS confirmed to be the safest technique to recognize the elements of the Calot triangle and, if correctly performed, it significantly impacted on preventing intraoperative complications. Additional educational programs on the correct application of CVS in clinical practice would be desirable to avoid extreme conditions that may require additional procedures.

Published
2020

12. Evaluation of Clinical Outcomes After Revascularization in Patients With Chronic Limb-Threatening Ischemia: Results From a Prospective National Cohort Study (RIVALUTANDO)

Author

de Donato, G., Benedetto, F., Stilo, F., Chiesa, R., Palombo, D., Pasqui, E., Panzano, C., Pulli, R., Novali, C., Silingardi, R., Grego, F., Palasciano, G., Setacci, C., Angiletta, G., Delia, S., Rivellini, C., Palombo, B., Pane, B., Spinella, G., Pipito, N., Spinelli, D., Derone, G., Tshomba, Y., Cilli, G., Lauricella, A., Maresca, L., Antonello, M., Piazza, M., Bonvini, S., Wassermann, V., Trani, A., Barresi, A., Licitra, G., Spinelli, F., Montelione, N., Paroni, G., Magistro, G., Ceriello, D., Merlo, M., Giordano, F., Ruzzi, U., Mazzitelli, G., Mele, M., Giannace, G., Alba, G., Grottola, G., Pazzaglia, M., Giubbolini, G., Baldi, B., Guerrieri, W., Benevento, D., Cappelli, A., Kahlberg, A., Carta, N., de Donato, G., Benedetto, F., Stilo, F., Chiesa, R., Palombo, D., Pasqui, E., Panzano, C., Pulli, R., Novali, C., Silingardi, R., Grego, F., Palasciano, G., Setacci, C., Angiletta, G., Delia, S., Rivellini, C., Palombo, B., Pane, B., Spinella, G., Pipito, N., Spinelli, D., Derone, G., Tshomba, Y., Cilli, G., Lauricella, A., Maresca, L., Antonello, M., Piazza, M., Bonvini, S., Wassermann, V., Trani, A., Barresi, A., Licitra, G., Spinelli, F., Montelione, N., Paroni, G., Magistro, G., Ceriello, D., Merlo, M., Giordano, F., Ruzzi, U., Mazzitelli, G., Mele, M., Giannace, G., Alba, G., Grottola, G., Pazzaglia, M., Giubbolini, G., Baldi, B., Guerrieri, W., Benevento, D., Cappelli, A., Kahlberg, A., and Carta, N.

Subjects
Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Revascularization, Risk Assessment, Amputation, Surgical, chronic limb-threatening ischemia, limb salvage, medical treatment, peripheral arterial disease, revascularization, Aged, Amputation, Cardiovascular Agents, Chronic Disease, Female, Humans, Ischemia, Italy, Limb Salvage, Peripheral Arterial Disease, Prospective Studies, Recurrence, Registries, Risk Factors, Treatment Outcome, Endovascular Procedures, Vascular Surgical Procedures, Internal medicine, medicine, Prospective cohort study, business.industry, Hazard ratio, Cilostazol, Cardiovascular agent, Cardiology and Cardiovascular Medicine, business, Iloprost, medicine.drug, Cohort study
Abstract

We evaluated the outcomes of revascularization in patients with chronic limb-threatening ischemia (CLTI) treated in real-world settings. This is a prospective multicenter cohort study with 12-month follow-up enrolling patients (n = 287) with CLTI undergoing open, endovascular, or hybrid lower extremity revascularization. The primary end point was amputation-free survival (AFS) at 12 months. Cox proportional analysis was used to determine independent predictors of amputation and restenosis. At 30 days, major adverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%, respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and the primary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis, smoking (hazard ratio [HR] = 2.2, P = 0.04), renal failure (HR = 2.3, P = 0.03), Rutherford class (≥5) (HR = 3.2, P = 0.01), and below-the-knee disease (HR = 2.0, P = 0.05) were significant predictors of amputation; iloprost infusion (>10 vials) (HR = 0.64, P = 0.05) was a significant protective factor. Cilostazol administration (HR = 0.77, P = 0.05) was a significant protective factor for restenosis. Results from this prospective multicenter registry offer a consistent overview of clinical outcomes of CLTI patients at 1 year when adequately revascularized. Medical treatment, including statins, cilostazol and iloprost, were associated with improved 1-year freedom from restenosis and amputation.

Published
2021

17. Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Author

Halliday, A., Bulbulia, R., Bonati, L. H., Chester, J., Cradduck-Bamford, A., Peto, R., Pan, H., Potter, J., Henning Eckstein, H., Farrell, B., Flather, M., Mansfield, A., Mihaylova, B., Rahimi, K., Simpson, D., Thomas, D., Sandercock, P., Gray, R., Molyneux, A., Shearman, C. P., Rothwell, P., Belli, A., Herrington, W., Judge, P., Leopold, P., Mafham, M., Gough, M., Cao, P., Macdonald, S., Bari, V., Berry, C., Bradshaw, S., Brudlo, W., Clarke, A., Cox, R., Fathers, S., Gaba, K., Gray, M., Hayter, E., Holliday, C., Kurien, R., Lay, M., le Conte, S., Mcmanus, J., Madgwick, Z., Morris, D., Munday, A., Pickworth, S., Ostasz, W., Poorthuis, M., Richards, S., Teixeira, L., Tochlin, S., Tully, L., Wallis, C., Willet, M., Young, A., Casana, R., Malloggi, C., Odero, A., Silani, V., Parati, G., Malchiodi, G., Malferrari, G., Strozzi, F., Tusini, N., Vecchiati, E., Coppi, G., Lauricella, A., Moratto, R., Silingardi, R., Veronesi, J., Zini, A., Ferrero, E., Ferri, M., Gaggiano, A., Labate, C., Nessi, F., Psacharopulo, D., Viazzo, A., Malacrida, G., Mazzaccaro, D., Meola, G., Modafferi, A., Nano, G., Occhiuto, M. T., Righini, P., Stegher, S., Chiarandini, S., Griselli, F., Lepidi, S., Pozzi Mucelli, F., Naccarato, M., D'Oria, M., Ziani, B., Stella, A., Dieng, M., Faggioli, G., Gargiulo, M., Palermo, S., Pini, R., Puddu, G. M., Vacirca, A., Angiletta, D., Desantis, C., Marinazzo, D., Mastrangelo, G., Regina, G., Pulli, R., Bianchi, P., Cireni, L., Coppi, E., Pizzirusso, R., Scalise, F., Sorropago, G., Tolva, V., Caso, V., Cieri, E., Derango, P., Farchioni, L., Isernia, G., Lenti, M., Parlani, G. B., Pupo, G., Pula, G., Simonte, G., Verzini, F., Carimati, F., Delodovici, M. L., Fontana, F., Piffaretti, G., Tozzi, M., Civilini, E., Poletto, G., Reimers, B., Praquin, B., Ronchey, S., Capoccia, L., Mansour, W., Sbarigia, E., Speziale, F., Sirignano, P., Toni, D., Galeotti, R., Gasbarro, V., Mascoli, F., Rocca, T., Tsolaki, E., Bernardini, G., Demarco, E., Giaquinta, A., Patti, F., Veroux, M., Veroux, P., Virgilio, C., Mangialardi, N., Orrico, M., Di Lazzaro, V., Montelione, N., Spinelli, F., Stilo, F., Cernetti, C., Irsara, S., Maccarrone, G., Tonello, D., Visona, A., Zalunardo, B., Chisci, E., Michelagnoli, S., Troisi, N., Masato, M., Dei Negri, M., Pacchioni, A., Sacca, S., Amatucci, G., Cannizzaro, A., Accrocca, F., Ambrogi, C., Barbazza, R., Marcucci, G., Siani, A., Bajardi, G., Savettieri, G., Argentieri, A., Corbetta, R., Quaretti, P., Thyrion, F. Z., Cappelli, A., Benevento, D., De Donato, G., Mele, M. A., Palasciano, G., Pieragalli, D., Rossi, A., Setacci, C., Setacci, F., Palombo, D., Perfumo, M. C., Martelli, E., Paolucci, A., Trimarchi, S., Grassi, V., Grimaldi, L., La Rosa, G., Mirabella, D., Scialabba, M., Sichel, L., D'Angelo, C. L., Fadda, G. F., Kasemi, H., Marino, M., Burzotta, Francesco, Codispoti, F. A., Ferrante, A., Tinelli, Giovanni, Tshomba, Yamume, Vincenzoni, Claudio, Amis, D., Anderson, D., Catterson, M., Clarke, M., Davis, M., Dixit, A., Dyker, A., Ford, G., Jackson, R., Kappadath, S., Lambert, D., Lees, T., Louw, S., Mccaslin, J., Parr, N., Robson, R., Stansby, G., Wales, L., Wealleans, V., Wilson, L., Wyatt, M., Baht, H., Balogun, I., Burger, I., Cosier, T., Cowie, L., Gunathilagan, G., Hargroves, D., Insall, R., Jones, S., Rudenko, H., Schumacher, N., Senaratne, J., Thomas, G., Thomson, A., Webb, T., Brown, E., Esisi, B., Mehrzad, A., Macsweeney, S., Mcconachie, N., Southam, A., Sunman, W., Abdul-Hamiq, A., Bryce, J., Chetter, I., Ettles, D., Lakshminarayan, R., Mitchelson, K., Rhymes, C., Robinson, G., Scott, P., Vickers, A., Ashleigh, R., Butterfield, S., Gamble, E., Ghosh, J., Mccollum, C. N., Welch, M., Welsh, S., Wolowczyk, L., Donnelly, M., D'Souza, S., Egun, A. A., Gregary, B., Joseph, T., Kelly, C., Punekar, S., Rahi, M. A., Raj, S., Seriki, D., Thomson, G., Brown, J., Durairajan, R., Grunwald, I., Guyler, P., Harman, P., Jakeways, M., Khuoge, C., Kundu, A., Loganathan, T., Menon, N., Prabakaran, R. O., Sinha, D., Thompson, V., Tysoe, S., Briley, D., Darby, C., Hands, L., Howard, D., Kuker, W., Schulz, U., Teal, R., Barer, D., Brown, A., Crawford, S., Dunlop, P., Krishnamurthy, R., Majmudar, N., Mitchell, D., Myint, M. P., O'Brien, R., O'Connell, J., Sattar, N., Vetrivel, S., Beard, J., Cleveland, T., Gaines, P., Humphreys, J., Jenkins, A., King, C., Kusuma, D., Lindert, R., Lonsdale, R., Nair, R., Nawaz, S., Okhuoya, F., Turner, D., Venables, G., Dorman, P., Hughes, A., Jones, D., Mendelow, D., Rodgers, H., Raudoniitis, A., Enevoldson, P., Nahser, H., O'Brien, I., Torella, F., Watling, D., White, R., Brown, P., Dutta, D., Emerson, L., Hilltout, P., Kulkarni, S., Morrison, J., Poskitt, K., Slim, F., Smith, S., Tyler, A., Waldron, J., Whyman, M., Bajoriene, M., Baker, L., Colston, A., Eliot-Jones, B., Gramizadeh, G., Lewis-Clarke, C., Mccafferty, L., Oliver, D., Palmer, D., Patil, A., Pegler, S., Ramadurai, G., Roberts, A., Sargent, T., Siddegowda, S., Singh-Ranger, R., Williams, A., Williams, L., Windebank, S., Zuromskis, T., Alwis, L., Angus, J., Asokanathan, A., Fornolles, C., Hardy, D., Hunte, S., Justin, F., Phiri, D., Mitabouana-Kibou, M., Sekaran, L., Sethuraman, S., Tate, M. L., Akyea-Mensah, J., Ball, S., Chrisopoulou, A., Keene, E., Phair, A., Rogers, S., Smyth, J. V., Bicknell, C., Chataway, J., Cheshire, N., Clifton, A., Eley, C., Gibbs, R., Hamady, M., Hazel, B., James, A., Jenkins, M., Khanom, N., Lacey, A., Mireskandari, M., O'Reilly, J., Pereira, A., Sachs, T., Wolfe, J., Davey, P., Rogers, G., Smith, G., Tervit, G., Nichol, I., Parry, A., Young, G., Ashley, S., Barwell, J., Dix, F., Nor, A. M., Parry, C., Birt, A., Davies, P., George, J., Graham, A., Jonker, L., Kelsall, N., Potts, C., Wilson, T., Crinnion, J., Cuenoud, L., Aleksic, N., Babic, S., Ilijevski, N., Radak, Sagic, D., Tanaskovic, S., Colic, M., Cvetic, V., Davidovic, L., Jovanovic, D. R., Koncar, I., Mutavdzic, P., Sladojevic, M., Tomic, I., Debus, E. S., Grzyska, U., Otto, D., Thomalla, G., Barlinn, J., Gerber, J., Haase, K., Hartmann, C., Ludwig, S., Putz, V., Reeps, C., Schmidt, C., Weiss, N., Werth, S., Winzer, S., Gemper, J., Gunther, A., Heiling, B., Jochmann, E., Karvouniari, P., Klingner, C., Mayer, T., Schubert, J., Schulze-Hartung, F., Zanow, J., Bausback, Y., Borger, F., Botsios, S., Branzan, D., Braunlich, S., Holzer, H., Lenzer, J., Piorkowski, C., Richter, N., Schuster, J., Scheinert, D., Schmidt, A., Staab, H., Ulrich, M., Werner, M., Berger, H., Biro, G., Eckstein, H. -H., Kallmayer, M., Kreiser, K., Zimmermann, A., Berekoven, B., Frerker, K., Gordon, V., Torsello, G., Arnold, S., Dienel, C., Storck, M., Biermaier, B., Gissler, H. M., Klotzsch, C., Pfeiffer, T., Schneider, R., Sohl, L., Wennrich, M., Alonso, A., Keese, M., Groden, C., Coster, A., Engelhardt, A., Ratusinski, C. -M., Berg, B., Delle, M., Formgren, J., Gillgren, P., Jarl, L., Kall, T. B., Konrad, P., Nyman, N., Skioldebrand, C., Steuer, J., Takolander, R., Malmstedt, J., Acosta, S., Bjorses, K., Brandt, K., Dias, N., Gottsater, A., Holst, J., Kristmundsson, T., Kuhme, T., Kolbel, T., Lindblad, B., Lindh, M., Malina, M., Ohrlander, T., Resch, T., Ronnle, V., Sonesson, B., Warvsten, M., Zdanowski, Z., Campbell, E., Kjellin, P., Lindgren, H., Nyberg, J., Petersen, B., Plate, G., Parsson, H., Qvarfordt, P., Ignatenko, P., Karpenko, A., Starodubtsev, V., Chernyavsky, M. A., Golovkova, M. S., Komakha, B. B., Zherdev, N. N., Belyasnik, A., Chechulov, P., Kandyba, D., Stepanishchev, I., Csobay-Novak, C., Dosa, E., Entz, L., Nemes, B., Szeberin, Z., Barzo, P., Bodosi, M., Fako, E., Fulop, B., Nemeth, T., Pazdernyik, S., Skoba, K., Voros, E., Chatzinikou, E., Giannoukas, A., Karathanos, C., Koutsias, S., Kouvelos, G., Matsagkas, M., Ralli, S., Rountas, C., Rousas, N., Spanos, K., Brountzos, E., Kakisis, J. D., Lazaris, A., Moulakakis, K. G., Stefanis, L., Tsivgoulis, G., Vasdekis, S., Antonopoulos, C. N., Bellenis, I., Maras, D., Polydorou, A., Polydorou, V., Tavernarakis, A., Ioannou, N., Terzoudi, M., Lazarides, M., Mantatzis, M., Vadikolias, K., Dzieciuchowicz, L., Gabriel, M., Krasinski, Z., Oszkinis, G., Pukacki, F., Slowinski, M., Stanisic, M. -G., Staniszewski, R., Tomczak, J., Zielinski, M., Myrcha, P., Rozanski, D., Drelichowski, S., Iwanowski, W., Koncewicz, K., Bialek, P., Biejat, Z., Czepel, W., Czlonkowska, A., Dowzenko, A., Jedrzejewska, J., Kobayashi, A., Leszczynski, J., Malek, A., Polanski, J., Proczka, R., Skorski, M., Szostek, M., Andziak, P., Dratwicki, M., Gil, R., Nowicki, M., Pniewski, J., Rzezak, J., Seweryniak, P., Dabek, P., Juszynski, M., Madycki, G., Pacewski, B., Raciborski, W., Slowinski, P., Staszkiewicz, W., Bombic, M., Chlouba, V., Fiedler, J., Hes, K., Kostal, P., Sova, J., Kriz, Z., Privara, M., Reif, M., Staffa, R., Vlachovsky, R., Vojtisek, B., Hrbac, T., Kuliha, M., Prochazka, V., Roubec, M., Skoloudik, D., Netuka, D., Steklacova, A., Benes III, V., Buchvald, P., Endrych, L., Sercl, M., Campos, W., Casella, I. B., de Luccia, N., Estenssoro, A. E. V., Presti, C., Puech-Leao, P., Neves, C. R. B., da Silva, E. S., Sitrangulo, C. J., Monteiro, J. A. T., Tinone, G., Bellini Dalio, M., Joviliano, E. E., Pontes Neto, O. M., Serra Ribeiro, M., Cras, P., Hendriks, J. M. H., Hoppenbrouwers, M., Lauwers, P., Loos, C., Yperzeele, L., Geenens, M., Hemelsoet, D., van Herzeele, I., Vermassen, F., Astarci, P., Hammer, F., Lacroix, V., Peeters, A., Verhelst, R., Cirelli, S., Dormal, P., Grimonprez, A., Lambrecht, B., Lerut, P., Thues, E., De Koster, G., Desiron, Q., Maertens de Noordhout, A., Malmendier, D., Massoz, M., Saad, G., Bosiers, M., Callaert, J., Deloose, K., Blanco Canibano, E., Garcia Fresnillo, B., Guerra Requena, M., Morata Barrado, P. C., Muela Mendez, M., Yusta Izquierdo, A., Aparici Robles, F., Blanes Orti, P., Garcia Dominguez, L., Martinez Lopez, R., Miralles Hernandez, M., Tembl Ferrairo, J. I., Chamorro, A., Macho, J., Obach, V., Riambau, V., San Roman, L., Ahlhelm, F. J., Blackham, K., Engelter, S., Eugster, T., Gensicke, H., Gurke, L., Lyrer, P., Mariani, L., Maurer, M., Mujagic, E., Muller, M., Psychogios, M., Stierli, P., Stippich, C., Traenka, C., Wolff, T., Wagner, B., Wiegert, M. M., Clarke, S., Diepers, M., Grochenig, E., Gruber, P., Isaak, A., Kahles, T., Marti, R., Nedeltchev, K., Remonda, L., Tissira, N., Valenca Falcao, M., de Borst, G. J., Lo, R. H., Moll, F. L., Toorop, R., van der Worp, B. H., Vonken, E. J., Kappelle, J. L., Jahrome, O., Vos, F., Schuiling, W., van Overhagen, H., Keunen, R. W. M., Knippenberg, B., Wever, J. J., Lardenoije, J. W., Reijnen, M., Smeets, L., van Sterkenburg, S., Fraedrich, G., Gizewski, E., Gruber, I., Knoflach, M., Kiechl, S., Rantner, B., Abdulamit, T., Bergeron, P., Padovani, R., Trastour, J. -C., Cardon, J. -M., Le Gallou-Wittenberg, A., Allaire, E., Becquemin, J. -P., Cochennec-Paliwoda, F., Desgranges, P., Hosseini, H., Kobeiter, H., Marzelle, J., Almekhlafi, M. A., Bal, S., Barber, P. A., Coutts, S. B., Demchuk, A. M., Eesa, M., Gillies, M., Goyal, M., Hill, M. D., Hudon, M. E., Jambula, A., Kenney, C., Klein, G., Mcclelland, M., Mitha, A., Menon, B. K., Morrish, W. F., Peters, S., Ryckborst, K. J., Samis, G., Save, S., Smith, E. E., Stys, P., Subramaniam, S., Sutherland, G. R., Watson, T., Wong, J. H., Zimmel, L., Flis, V., Matela, J., Miksic, K., Milotic, F., Mrdja, B., Stirn, B., Tetickovic, E., Gasparini, M., Grad, A., Kompara, I., Milosevic, Z., Palmiste, V., Toomsoo, T., Aidashova, B., Kospanov, N., Lyssenko, R., Mussagaliev, D., Beyar, R., Hoffman, A., Karram, T., Kerner, A., Nikolsky, E., Nitecki, S., Andonova, S., Bachvarov, C., Petrov, V., Cvjetko, I., Vidjak, V., Haluzan, D., Petrunic, M., Liu, B., Liu, C. -W., Bartko, D., Beno, P., Rusnak, F., Zelenak, K., Ezura, M., Inoue, T., Kimura, N., Kondo, R., Matsumoto, Y., Shimizu, H., Endo, H., Furui, E., Bakke, S., Krohg-Sorensen, K., Nome, T., Skjelland, M., Tennoe, B., Albuquerque e Castro, J., Alves, G., Bastos Goncalves, F., de Aragao Morais, J., Garcia, A. C., Valentim, H., Vasconcelos, L., Belcastro, F., Cura, F., Zaefferer, P., Abd-Allah, F., Eldessoki, M. H., Heshmat Kassem, H., Soliman Gharieb, H., Colgan, M. P., Haider, S. N., Harbison, J., Madhavan, P., Moore, D., Shanik, G., Kazan, V., Nazzal, M., Ramsey-Williams, V., Burzotta F. (ORCID:0000-0002-6569-9401), Tinelli G. (ORCID:0000-0002-2212-3226), Tshomba Y. (ORCID:0000-0001-7304-7553), Vincenzoni C., Halliday, A., Bulbulia, R., Bonati, L. H., Chester, J., Cradduck-Bamford, A., Peto, R., Pan, H., Potter, J., Henning Eckstein, H., Farrell, B., Flather, M., Mansfield, A., Mihaylova, B., Rahimi, K., Simpson, D., Thomas, D., Sandercock, P., Gray, R., Molyneux, A., Shearman, C. P., Rothwell, P., Belli, A., Herrington, W., Judge, P., Leopold, P., Mafham, M., Gough, M., Cao, P., Macdonald, S., Bari, V., Berry, C., Bradshaw, S., Brudlo, W., Clarke, A., Cox, R., Fathers, S., Gaba, K., Gray, M., Hayter, E., Holliday, C., Kurien, R., Lay, M., le Conte, S., Mcmanus, J., Madgwick, Z., Morris, D., Munday, A., Pickworth, S., Ostasz, W., Poorthuis, M., Richards, S., Teixeira, L., Tochlin, S., Tully, L., Wallis, C., Willet, M., Young, A., Casana, R., Malloggi, C., Odero, A., Silani, V., Parati, G., Malchiodi, G., Malferrari, G., Strozzi, F., Tusini, N., Vecchiati, E., Coppi, G., Lauricella, A., Moratto, R., Silingardi, R., Veronesi, J., Zini, A., Ferrero, E., Ferri, M., Gaggiano, A., Labate, C., Nessi, F., Psacharopulo, D., Viazzo, A., Malacrida, G., Mazzaccaro, D., Meola, G., Modafferi, A., Nano, G., Occhiuto, M. T., Righini, P., Stegher, S., Chiarandini, S., Griselli, F., Lepidi, S., Pozzi Mucelli, F., Naccarato, M., D'Oria, M., Ziani, B., Stella, A., Dieng, M., Faggioli, G., Gargiulo, M., Palermo, S., Pini, R., Puddu, G. M., Vacirca, A., Angiletta, D., Desantis, C., Marinazzo, D., Mastrangelo, G., Regina, G., Pulli, R., Bianchi, P., Cireni, L., Coppi, E., Pizzirusso, R., Scalise, F., Sorropago, G., Tolva, V., Caso, V., Cieri, E., Derango, P., Farchioni, L., Isernia, G., Lenti, M., Parlani, G. B., Pupo, G., Pula, G., Simonte, G., Verzini, F., Carimati, F., Delodovici, M. L., Fontana, F., Piffaretti, G., Tozzi, M., Civilini, E., Poletto, G., Reimers, B., Praquin, B., Ronchey, S., Capoccia, L., Mansour, W., Sbarigia, E., Speziale, F., Sirignano, P., Toni, D., Galeotti, R., Gasbarro, V., Mascoli, F., Rocca, T., Tsolaki, E., Bernardini, G., Demarco, E., Giaquinta, A., Patti, F., Veroux, M., Veroux, P., Virgilio, C., Mangialardi, N., Orrico, M., Di Lazzaro, V., Montelione, N., Spinelli, F., Stilo, F., Cernetti, C., Irsara, S., Maccarrone, G., Tonello, D., Visona, A., Zalunardo, B., Chisci, E., Michelagnoli, S., Troisi, N., Masato, M., Dei Negri, M., Pacchioni, A., Sacca, S., Amatucci, G., Cannizzaro, A., Accrocca, F., Ambrogi, C., Barbazza, R., Marcucci, G., Siani, A., Bajardi, G., Savettieri, G., Argentieri, A., Corbetta, R., Quaretti, P., Thyrion, F. Z., Cappelli, A., Benevento, D., De Donato, G., Mele, M. A., Palasciano, G., Pieragalli, D., Rossi, A., Setacci, C., Setacci, F., Palombo, D., Perfumo, M. C., Martelli, E., Paolucci, A., Trimarchi, S., Grassi, V., Grimaldi, L., La Rosa, G., Mirabella, D., Scialabba, M., Sichel, L., D'Angelo, C. L., Fadda, G. F., Kasemi, H., Marino, M., Burzotta, Francesco, Codispoti, F. A., Ferrante, A., Tinelli, Giovanni, Tshomba, Yamume, Vincenzoni, Claudio, Amis, D., Anderson, D., Catterson, M., Clarke, M., Davis, M., Dixit, A., Dyker, A., Ford, G., Jackson, R., Kappadath, S., Lambert, D., Lees, T., Louw, S., Mccaslin, J., Parr, N., Robson, R., Stansby, G., Wales, L., Wealleans, V., Wilson, L., Wyatt, M., Baht, H., Balogun, I., Burger, I., Cosier, T., Cowie, L., Gunathilagan, G., Hargroves, D., Insall, R., Jones, S., Rudenko, H., Schumacher, N., Senaratne, J., Thomas, G., Thomson, A., Webb, T., Brown, E., Esisi, B., Mehrzad, A., Macsweeney, S., Mcconachie, N., Southam, A., Sunman, W., Abdul-Hamiq, A., Bryce, J., Chetter, I., Ettles, D., Lakshminarayan, R., Mitchelson, K., Rhymes, C., Robinson, G., Scott, P., Vickers, A., Ashleigh, R., Butterfield, S., Gamble, E., Ghosh, J., Mccollum, C. N., Welch, M., Welsh, S., Wolowczyk, L., Donnelly, M., D'Souza, S., Egun, A. A., Gregary, B., Joseph, T., Kelly, C., Punekar, S., Rahi, M. A., Raj, S., Seriki, D., Thomson, G., Brown, J., Durairajan, R., Grunwald, I., Guyler, P., Harman, P., Jakeways, M., Khuoge, C., Kundu, A., Loganathan, T., Menon, N., Prabakaran, R. O., Sinha, D., Thompson, V., Tysoe, S., Briley, D., Darby, C., Hands, L., Howard, D., Kuker, W., Schulz, U., Teal, R., Barer, D., Brown, A., Crawford, S., Dunlop, P., Krishnamurthy, R., Majmudar, N., Mitchell, D., Myint, M. P., O'Brien, R., O'Connell, J., Sattar, N., Vetrivel, S., Beard, J., Cleveland, T., Gaines, P., Humphreys, J., Jenkins, A., King, C., Kusuma, D., Lindert, R., Lonsdale, R., Nair, R., Nawaz, S., Okhuoya, F., Turner, D., Venables, G., Dorman, P., Hughes, A., Jones, D., Mendelow, D., Rodgers, H., Raudoniitis, A., Enevoldson, P., Nahser, H., O'Brien, I., Torella, F., Watling, D., White, R., Brown, P., Dutta, D., Emerson, L., Hilltout, P., Kulkarni, S., Morrison, J., Poskitt, K., Slim, F., Smith, S., Tyler, A., Waldron, J., Whyman, M., Bajoriene, M., Baker, L., Colston, A., Eliot-Jones, B., Gramizadeh, G., Lewis-Clarke, C., Mccafferty, L., Oliver, D., Palmer, D., Patil, A., Pegler, S., Ramadurai, G., Roberts, A., Sargent, T., Siddegowda, S., Singh-Ranger, R., Williams, A., Williams, L., Windebank, S., Zuromskis, T., Alwis, L., Angus, J., Asokanathan, A., Fornolles, C., Hardy, D., Hunte, S., Justin, F., Phiri, D., Mitabouana-Kibou, M., Sekaran, L., Sethuraman, S., Tate, M. L., Akyea-Mensah, J., Ball, S., Chrisopoulou, A., Keene, E., Phair, A., Rogers, S., Smyth, J. V., Bicknell, C., Chataway, J., Cheshire, N., Clifton, A., Eley, C., Gibbs, R., Hamady, M., Hazel, B., James, A., Jenkins, M., Khanom, N., Lacey, A., Mireskandari, M., O'Reilly, J., Pereira, A., Sachs, T., Wolfe, J., Davey, P., Rogers, G., Smith, G., Tervit, G., Nichol, I., Parry, A., Young, G., Ashley, S., Barwell, J., Dix, F., Nor, A. M., Parry, C., Birt, A., Davies, P., George, J., Graham, A., Jonker, L., Kelsall, N., Potts, C., Wilson, T., Crinnion, J., Cuenoud, L., Aleksic, N., Babic, S., Ilijevski, N., Radak, Sagic, D., Tanaskovic, S., Colic, M., Cvetic, V., Davidovic, L., Jovanovic, D. R., Koncar, I., Mutavdzic, P., Sladojevic, M., Tomic, I., Debus, E. S., Grzyska, U., Otto, D., Thomalla, G., Barlinn, J., Gerber, J., Haase, K., Hartmann, C., Ludwig, S., Putz, V., Reeps, C., Schmidt, C., Weiss, N., Werth, S., Winzer, S., Gemper, J., Gunther, A., Heiling, B., Jochmann, E., Karvouniari, P., Klingner, C., Mayer, T., Schubert, J., Schulze-Hartung, F., Zanow, J., Bausback, Y., Borger, F., Botsios, S., Branzan, D., Braunlich, S., Holzer, H., Lenzer, J., Piorkowski, C., Richter, N., Schuster, J., Scheinert, D., Schmidt, A., Staab, H., Ulrich, M., Werner, M., Berger, H., Biro, G., Eckstein, H. -H., Kallmayer, M., Kreiser, K., Zimmermann, A., Berekoven, B., Frerker, K., Gordon, V., Torsello, G., Arnold, S., Dienel, C., Storck, M., Biermaier, B., Gissler, H. M., Klotzsch, C., Pfeiffer, T., Schneider, R., Sohl, L., Wennrich, M., Alonso, A., Keese, M., Groden, C., Coster, A., Engelhardt, A., Ratusinski, C. -M., Berg, B., Delle, M., Formgren, J., Gillgren, P., Jarl, L., Kall, T. B., Konrad, P., Nyman, N., Skioldebrand, C., Steuer, J., Takolander, R., Malmstedt, J., Acosta, S., Bjorses, K., Brandt, K., Dias, N., Gottsater, A., Holst, J., Kristmundsson, T., Kuhme, T., Kolbel, T., Lindblad, B., Lindh, M., Malina, M., Ohrlander, T., Resch, T., Ronnle, V., Sonesson, B., Warvsten, M., Zdanowski, Z., Campbell, E., Kjellin, P., Lindgren, H., Nyberg, J., Petersen, B., Plate, G., Parsson, H., Qvarfordt, P., Ignatenko, P., Karpenko, A., Starodubtsev, V., Chernyavsky, M. A., Golovkova, M. S., Komakha, B. B., Zherdev, N. N., Belyasnik, A., Chechulov, P., Kandyba, D., Stepanishchev, I., Csobay-Novak, C., Dosa, E., Entz, L., Nemes, B., Szeberin, Z., Barzo, P., Bodosi, M., Fako, E., Fulop, B., Nemeth, T., Pazdernyik, S., Skoba, K., Voros, E., Chatzinikou, E., Giannoukas, A., Karathanos, C., Koutsias, S., Kouvelos, G., Matsagkas, M., Ralli, S., Rountas, C., Rousas, N., Spanos, K., Brountzos, E., Kakisis, J. D., Lazaris, A., Moulakakis, K. G., Stefanis, L., Tsivgoulis, G., Vasdekis, S., Antonopoulos, C. N., Bellenis, I., Maras, D., Polydorou, A., Polydorou, V., Tavernarakis, A., Ioannou, N., Terzoudi, M., Lazarides, M., Mantatzis, M., Vadikolias, K., Dzieciuchowicz, L., Gabriel, M., Krasinski, Z., Oszkinis, G., Pukacki, F., Slowinski, M., Stanisic, M. -G., Staniszewski, R., Tomczak, J., Zielinski, M., Myrcha, P., Rozanski, D., Drelichowski, S., Iwanowski, W., Koncewicz, K., Bialek, P., Biejat, Z., Czepel, W., Czlonkowska, A., Dowzenko, A., Jedrzejewska, J., Kobayashi, A., Leszczynski, J., Malek, A., Polanski, J., Proczka, R., Skorski, M., Szostek, M., Andziak, P., Dratwicki, M., Gil, R., Nowicki, M., Pniewski, J., Rzezak, J., Seweryniak, P., Dabek, P., Juszynski, M., Madycki, G., Pacewski, B., Raciborski, W., Slowinski, P., Staszkiewicz, W., Bombic, M., Chlouba, V., Fiedler, J., Hes, K., Kostal, P., Sova, J., Kriz, Z., Privara, M., Reif, M., Staffa, R., Vlachovsky, R., Vojtisek, B., Hrbac, T., Kuliha, M., Prochazka, V., Roubec, M., Skoloudik, D., Netuka, D., Steklacova, A., Benes III, V., Buchvald, P., Endrych, L., Sercl, M., Campos, W., Casella, I. B., de Luccia, N., Estenssoro, A. E. V., Presti, C., Puech-Leao, P., Neves, C. R. B., da Silva, E. S., Sitrangulo, C. J., Monteiro, J. A. T., Tinone, G., Bellini Dalio, M., Joviliano, E. E., Pontes Neto, O. M., Serra Ribeiro, M., Cras, P., Hendriks, J. M. H., Hoppenbrouwers, M., Lauwers, P., Loos, C., Yperzeele, L., Geenens, M., Hemelsoet, D., van Herzeele, I., Vermassen, F., Astarci, P., Hammer, F., Lacroix, V., Peeters, A., Verhelst, R., Cirelli, S., Dormal, P., Grimonprez, A., Lambrecht, B., Lerut, P., Thues, E., De Koster, G., Desiron, Q., Maertens de Noordhout, A., Malmendier, D., Massoz, M., Saad, G., Bosiers, M., Callaert, J., Deloose, K., Blanco Canibano, E., Garcia Fresnillo, B., Guerra Requena, M., Morata Barrado, P. C., Muela Mendez, M., Yusta Izquierdo, A., Aparici Robles, F., Blanes Orti, P., Garcia Dominguez, L., Martinez Lopez, R., Miralles Hernandez, M., Tembl Ferrairo, J. I., Chamorro, A., Macho, J., Obach, V., Riambau, V., San Roman, L., Ahlhelm, F. J., Blackham, K., Engelter, S., Eugster, T., Gensicke, H., Gurke, L., Lyrer, P., Mariani, L., Maurer, M., Mujagic, E., Muller, M., Psychogios, M., Stierli, P., Stippich, C., Traenka, C., Wolff, T., Wagner, B., Wiegert, M. M., Clarke, S., Diepers, M., Grochenig, E., Gruber, P., Isaak, A., Kahles, T., Marti, R., Nedeltchev, K., Remonda, L., Tissira, N., Valenca Falcao, M., de Borst, G. J., Lo, R. H., Moll, F. L., Toorop, R., van der Worp, B. H., Vonken, E. J., Kappelle, J. L., Jahrome, O., Vos, F., Schuiling, W., van Overhagen, H., Keunen, R. W. M., Knippenberg, B., Wever, J. J., Lardenoije, J. W., Reijnen, M., Smeets, L., van Sterkenburg, S., Fraedrich, G., Gizewski, E., Gruber, I., Knoflach, M., Kiechl, S., Rantner, B., Abdulamit, T., Bergeron, P., Padovani, R., Trastour, J. -C., Cardon, J. -M., Le Gallou-Wittenberg, A., Allaire, E., Becquemin, J. -P., Cochennec-Paliwoda, F., Desgranges, P., Hosseini, H., Kobeiter, H., Marzelle, J., Almekhlafi, M. A., Bal, S., Barber, P. A., Coutts, S. B., Demchuk, A. M., Eesa, M., Gillies, M., Goyal, M., Hill, M. D., Hudon, M. E., Jambula, A., Kenney, C., Klein, G., Mcclelland, M., Mitha, A., Menon, B. K., Morrish, W. F., Peters, S., Ryckborst, K. J., Samis, G., Save, S., Smith, E. E., Stys, P., Subramaniam, S., Sutherland, G. R., Watson, T., Wong, J. H., Zimmel, L., Flis, V., Matela, J., Miksic, K., Milotic, F., Mrdja, B., Stirn, B., Tetickovic, E., Gasparini, M., Grad, A., Kompara, I., Milosevic, Z., Palmiste, V., Toomsoo, T., Aidashova, B., Kospanov, N., Lyssenko, R., Mussagaliev, D., Beyar, R., Hoffman, A., Karram, T., Kerner, A., Nikolsky, E., Nitecki, S., Andonova, S., Bachvarov, C., Petrov, V., Cvjetko, I., Vidjak, V., Haluzan, D., Petrunic, M., Liu, B., Liu, C. -W., Bartko, D., Beno, P., Rusnak, F., Zelenak, K., Ezura, M., Inoue, T., Kimura, N., Kondo, R., Matsumoto, Y., Shimizu, H., Endo, H., Furui, E., Bakke, S., Krohg-Sorensen, K., Nome, T., Skjelland, M., Tennoe, B., Albuquerque e Castro, J., Alves, G., Bastos Goncalves, F., de Aragao Morais, J., Garcia, A. C., Valentim, H., Vasconcelos, L., Belcastro, F., Cura, F., Zaefferer, P., Abd-Allah, F., Eldessoki, M. H., Heshmat Kassem, H., Soliman Gharieb, H., Colgan, M. P., Haider, S. N., Harbison, J., Madhavan, P., Moore, D., Shanik, G., Kazan, V., Nazzal, M., Ramsey-Williams, V., Burzotta F. (ORCID:0000-0002-6569-9401), Tinelli G. (ORCID:0000-0002-2212-3226), Tshomba Y. (ORCID:0000-0001-7304-7553), and Vincenzoni C.

Abstract

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA

Published
2021

20. The TAXINOMISIS Project: A multidisciplinary approach for the development of a new risk stratification model for patients with asymptomatic carotid artery stenosis

Author

Timmerman, N. Galyfos, G. Sigala, F. Thanopoulou, K. de Borst, G.J. Davidovic, L. Eckstein, H.-H. Filipovic, N. Grugni, R. Kallmayer, M. de Kleijn, D.P.V. Koncar, I. Mantzaris, M.D. Marchal, E. Matsagkas, M. Mutavdzic, P. Palombo, D. Pasterkamp, G. Potsika, V.T. Andreakos, E. Fotiadis, D.I. all partners of the TAXINOMISIS Consortium

Abstract

Introduction: Asymptomatic carotid artery stenosis (ACAS) may cause future stroke and therefore patients with ACAS require best medical treatment. Patients at high risk for stroke may opt for additional revascularization (either surgery or stenting) but the future stroke risk should outweigh the risk for peri/post-operative stroke/death. Current risk stratification for patients with ACAS is largely based on outdated rand-omized-controlled trials that lack the integration of improved medical therapies and risk factor control. Furthermore, recent circulating and imaging biomarkers for stroke have never been included in a risk stratification model. The TAXINOMISIS Project aims to develop a new risk stratification model for cerebrovascular complications in patients with ACAS and this will be tested through a prospective observational multicentre clinical trial performed in six major European vascular surgery centres. Methods and analysis: The risk stratification model will compromise clinical, circulating, plaque and imaging biomarkers. The prospective multicentre observational study will include 300 patients with 50%-99% ACAS. The primary endpoint is the three-year incidence of cerebrovascular complications. Biomarkers will be re-trieved from plasma samples, brain MRI, carotid MRA and duplex ultrasound. The TAXINOMISIS Project will serve as a platform for the development of new computer tools that assess plaque progression based on radiology images and a lab-on-chip with genetic variants that could predict medication response in individual patients. Conclusion: Results from the TAXINOMISIS study could potentially improve future risk stratification in patients with ACAS to assist personalized evidence-based treatment decision-making. © 2020 The Authors.

Published
2020

26. Progress update from the hippocampal subfields group: [Brain Imaging Working Group Summaries for the European Joint Programming for Neurodegenerative Research (JPND)]

Author

Olsen, R., Carr, V., Daugherty, A., La Joie, R., Amaral, R., Amunts, K., Augustinack, J., Bakker, A., Bender, A., Berron, D., Boccardi, M., Bocchetta, M., Burggren, A., Chakravarty, M., Chételat, G., de Flores, R., DeKraker, J., Ding, S., Geerlings, M., Huang, Y., Insausti, R., Johnson, E., Kanel, P., Kedo, O., Kennedy, K., Keresztes, A., Lee, J., Lindenberger, U., https://orcid.org/0000-0001-8428-6453, Mueller, S., Mulligan, E., Ofen, N., Palombo, D., Pasquini, L., Pluta, J., Raz, N., https://orcid.org/0000-0002-5080-2138, Rodrigue, K., Schlichting, M., Shing, Y., Stark, C., Steve, T., Suthana, N., Wang, L., Werkle-Bergner, M., https://orcid.org/0000-0002-6399-9996, Yushkevich, P., Yu, Q., Wisse, L., and Hippocampal Subfields Group

Published
2019

36. Space Active Modular Materials Experiments (SAMMES): Low Earth Orbital mission aboard the Space Test Experiments STEP-3 platform

Author

Joshi, P, Palombo, D, Malonson, M, Whitehouse, W, Oakes, D, Green, B. D, Dicristina, V, Mckay, J, Nicholas, W, and Obal, M

Subjects
Chemistry And Materials (General)
Abstract

The requirement of satellite systems to survive in the space environment for 5 to 10 years to achieve greater cost effectiveness is discussed. Characterization of the orbital space environment and its effects on spacecraft systems have received considerable research attention. Instrumentation for long term measurement of key physical parameters characterizing the low Earth orbit (LEO) environment and its effects on degradation of spacecraft materials and solar arrays is reported. These measurements enable active, real time monitoring of the health of spacecraft and payload systems. SAMMES is designed to be autonomous, compact, low power, and lightweight.

Published
1994

43. Spinal cord stimulation or prostacyclin in unrevascularizable arteriopathy of lower limbs (SPINAL) study: interim analysis results

Author

Pedrini L, Ballestrazzi MS, Chierichetti F, Comandatore L, Magnoni F, Perkmann R, Castrucci T, and Palombo D

Subjects
critical limb ischemia, lcsh:Diseases of the circulatory (Cardiovascular) system, peripheral arterial disease, spinal cord stimulation, lcsh:RC666-701, limb salvage, Iloprost, prostanoids
Abstract

Luciano Pedrini,1 Maria Sandra Ballestrazzi,1 Fabio Chierichetti,2 Luigi Comandatore,3 Filippo Magnoni,1 Reinhold Perkmann,4 Tommaso Castrucci,5 Domenico Palombo6On behalf of the SPINAL Study Group1Operative Unit of Vascular Surgery, Maggiore Hospital of Bologna, Bologna, Italy; 2Operative Unit of Vascular Surgery, Circle Hospital of Busto Arsizio, Busto Arsizio, Italy; 3Operative Unit of Vascular Surgery, AEO Morelli of Sondalo, Sondalo, Italy; 4Operative Unit of Vascular and Thoracic Surgery, Hospital of Bolzano, Bolzano, Italy; 5Operative Unit of Vascular Surgery of Sant'Eugenio Hospital, Rome, Italy; 6Operative Unit of Vascular and Endovascular Surgery, IRCCS San Martino, Genoa, ItalyObjective: The aim of this study was to compare the clinical efficacy and the safety of spinal cord stimulation (SCS) plus medical treatment versus iloprost plus medical treatment in patients with severe unrevascularizable ischemia of the lower limbs due to atherosclerotic disease of the limbs and to identify predictive parameters for a positive outcome of SCS.Methods: A multicenter randomized controlled trial (RCT) with central randomization and core laboratory evaluation of angiography, subdivided into two treatment arms (SCS and iloprost) and two subgroups (rest pain and ulcer/gangrene). After the 15-day clinical efficacy evaluation, responder patients continued follow-up in their arm, while nonresponders could change arms or decline participation. The primary endpoint was 1-year limb salvage. Principal secondary endpoints were: survival rate; minor amputations and stump healing; ulcer healing; pain relief and analgesic intake; and predictive criteria for SCS treatment.Results: The trial was stopped at 35.6% of the expected sample due to low accrual rate. Fifty-two patients (55 legs) entered the study. At the 15-day efficacy evaluation, responders (reduced pain, no increase of ulcer area) comprised 74% of the SCS arm and 26% of the iloprost arm, (P=0.003). Nine nonresponders in the iloprost arm underwent SCS implantation. Three severe adverse events (one fatal) were recorded in the iloprost arm and four in SCS treatments. One-year limb salvage rates in SCS, iloprost treatment, and iloprost plus SCS implantation (I-SCS) were 66.8%, 57.1%, and 100%, respectively (P=0.09), and survival rates were 73.2%, 93.9%, and 88.9%, respectively (P=0.45), confirming results of other studies that showed a trend toward better amputation-free salvage in the SCS group. The small number of recruited patients prevented statistical significance being reached. Pain reduction was obtained in 87% of SCS patients and 35% of those in the iloprost arm (P=0.001). Among the examined parameters, only the angiographic resistance index was an independent predictive value of good results after SCS implantation.Discussion and conclusion: The SPINAL study is the first RCT comparing SCS and iloprost. Although incomplete, it evaluated a sample greater than those studied in three out of five available RCTs on SCS. However, the small sample size reduced the statistical power of the study, with possible type II errors. SCS was associated with a quick and more effective answer to pain, with better tolerability and better early results, than iloprost, but without significant 1-year limb salvage-rate improvement. Iloprost improved the 1-year survival in spite of adverse events, and, following these results, perhaps should be administered before other treatments. The results of this trial suggest that prostanoids and SCS are not alternative treatments: as prostanoids present many contraindications and side effects, SCS can be considered the complementary and consecutive treatment for patients who are no longer treatable with open or endovascular revascularizations, and an alternative treatment only in patients with contraindication to prostanoids. The association of iloprost and SCS seems to produce a synergic activity even in patients who had ineffective prostanoid treatment. These results should be confirmed by further investigations in a larger sample.Keywords: critical limb ischemia, iloprost, spinal cord stimulation, peripheral arterial disease

Published
2014

45. Minimally invasive approach to intrahepatic cholangiocarcinoma: technical notes for a safe hepatectomy and lymphadenectomy

Author

Fiorentini G, Ratti F, Cipriani F, Palombo D, Catena M, Paganelli M, Aldrighetti L, Fiorentini, G, Ratti, F, Cipriani, F, Palombo, D, Catena, M, Paganelli, M, and Aldrighetti, L

Subjects
Surgery
Abstract

Background: Despite the improvements of laparoscopic (I,PS) technologies and their extensive application to the treatment of liver diseases, minimally invasive approach to intrahepatic cholangiocarcinoma (ICC) is still poorly widespread. The aim of the present study is to investigate the extension and the diffusion of laparoscopy applied to surgical treatment of ICC. Methods: We reviewed studies dealing with the LPS treatment of ICC and LPS lymphadenectomy (LND) for ICC. Data regarding conversion rate, morbidity and LND were extracted, synthesized and analyzed. Additionally, we described technical notes for a safe liver resection and LND. Results: We identified 11 studies encompassing liver resections for ICCs. Among a total of 1,882 cases included, there were 101 (5.5%) patients treated laparoscopically who were affected by ICC. The observed conversion rate was comparable to that of other LPS advanced procedures; laparoscopy was not responsible for increased morbidity and LND was demonstrated being feasible without causing any increasing in the post-operative complications. Furthermore, no differences in disease free survival and on the 3-year overall survival were observed. Conclusions: Few are the cases of ICC that are nowadays tackled laparoscopically. Hepatic resection and LPS LND for ICC are feasible and safe; as more, laparoscopy granted both short and long term results that were comparable to open surgery, extending the applicability of minimally invasive surgery.

Published
2017
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46. Continuous epidural versus wound infusion plus single morphine bolus as postoperative analgesia in open abdominal aortic aneurysm repair: a randomized non-inferiority trial

Author

Lorenzo Ball, Pellerano, G., Corsi, L., Giudici, N., Pellegrino, A., Cannata, D., Santori, G., Palombo, D., Pelosi, P., and Gratarola, A.

Subjects
Local anesthesia, Postoperative pain, Epidural analgesia, Epidural analgesia, Local anesthesia, Postoperative pain, Vascular surgical procedures, Vascular surgical procedures
Published
2016

47. 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial

Author

Halliday, A, Harrison, M, Hayter, E, Kong, X, Mansfield, A, Marro, J, Pan, H, Peto, R, Potter, J, Rahimi, K, Rau, A, Robertson, S, Streifler, J, Thomas, D, Fraedrich G, Asymptomatic Carotid Surgery Trial Collaborative G. r. o. u. p., Schmidauer, C, Hölzenbein, Th, Huk, I, Haumer, M, Kretschmer, G, Metz, V, Polterauer, P, Teufelsbauer, H, Cras, P, Hendriks, J, Lauwers, P, Van Schil, P, de Souza EB, Dourado, Me, Gurgel, G, Rocha, Gm, Petrov, V, Slabakov, G, Cooper, Me, Gubitz, G, Holness, R, Howes, W, Langille, R, Legg, K, Nearing, S, Mackean, G, Mackay, M, Phillips, Sj, Sullivan, J, Wood, J, Erdelez, L, Sosa, T, Angelides, Ns, Christopoulos, G, Malikidou, A, Pesta, A, Ambler, Z, Mracek, J, Polivka, J, Rohan, V, Sevcik, P, Simaná, J, Benes, V, Kramár, F, Kaste, M, Lepäntalo, M, Soinne, L, Cardon, Jm, Legalou, A, Gengenbach, B, Pfadenhauer, K, Wölfl, Kd, Flessenkämper, I, Klumpp, Bf, Marsch, J, Kolvenbach, R, Pfeiff, T, Sandmann, W, Beyersdorf, F, Hetzel, A, Sarai, K, Schöllhorn, J, Spillner, G, Lutz, Hj, Böckler, D, Maeder, N, Busse, O, Grönniger, J, Haukamp, F, Balzer, K, Knoob, Hg, Roedig, G, Virreira, L, Franke, S, Moll, R, Schneider, J, Dayantas, J, Sechas, Mn, Tsiaza, S, Kiskinis, D, Apor, A, Dzinich, C, Entz, L, Hüttl, K, Jàrànyi, Z, Mogan, I, Nagy, Z, Szabo, A, Varga, D, Juhász, G, Mátyás, L, Hutchinson, M, Mehigan, D, Aladjem, Z, Harah, E, Elmakias, S, Gurvich, D, Yoffe, B, Ben Meir, H, Dagan, L, Karmeli, R, Keren, G, Shimony, A, Weller, B, Avrahami, R, Koren, R, Streifler, Jy, Tabachnik, S, Zelikovski, A, Angiletta, D, Federico, F, Impedovo, G, Marotta, V, Pascazio, L, Regina, G, Andreoli, A, Pozzati, E, Bonardelli, S, Giulini, Sm, Guarneri, B, Caiazzo, P, Mascoli, F, Becchi, G, Masini, R, Santoro, E, Simoni, G, Ventura, M, Scarpelli, P, Spartera, C, Arena, O, Collice, M, Puttini, M, Romani, F, Santilli, I, Segramora, V, Sterzi, R, Deriu, G, Verlato, F, Cao, Pg, Cieri, Enrico, De Rango, P, Moggi, L, Ricci, S, Antico, A, Spigonardo, F, Malferrari, G, 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Roberto, and Asymptomatic Carotid Surgery Trial Collaborative, Group

Subjects
Male, Time Factors, medicine.medical_treatment, Kaplan-Meier Estimate, Carotid endarterectomy, Aged, 80 and over, Carotid Stenosis, Endarterectomy, Carotid, Female, Humans, Incidence, Middle Aged, Primary Prevention, Stroke, Treatment Outcome, Stroke/epidemiology, law.invention, Randomized controlled trial, law, Aged, 80 and over, Endarterectomy, Carotid, endarterectomy, Carotid Stenosis/mortality, Incidence (epidemiology), Carotid*/mortality, General Medicine, Carotid Stenosis | Internal Carotid Artery | Endarterectomy, medicine.symptom, medicine.medical_specialty, Asymptomatic, Internal medicine, asymptomatic carotid artery stenosi, medicine, asymptomatic carotid artery stenosis, business.industry, Carotid Stenosis/complications, Stroke/prevention & control, Perioperative, medicine.disease, Surgery, Stenosis, Human medicine, business
Abstract

SummaryBackgroundIf carotid artery narrowing remains asymptomatic (ie, has caused no recent stroke or other neurological symptoms), successful carotid endarterectomy (CEA) reduces stroke incidence for some years. We assessed the long-term effects of successful CEA.MethodsBetween 1993 and 2003, 3120 asymptomatic patients from 126 centres in 30 countries were allocated equally, by blinded minimised randomisation, to immediate CEA (median delay 1 month, IQR 0·3–2·5) or to indefinite deferral of any carotid procedure, and were followed up until death or for a median among survivors of 9 years (IQR 6–11). The primary outcomes were perioperative mortality and morbidity (death or stroke within 30 days) and non-perioperative stroke. Kaplan-Meier percentages and logrank p values are from intention-to-treat analyses. This study is registered, number ISRCTN26156392.Findings1560 patients were allocated immediate CEA versus 1560 allocated deferral of any carotid procedure. The proportions operated on while still asymptomatic were 89·7% versus 4·8% at 1 year (and 92·1% vs 16·5% at 5 years). Perioperative risk of stroke or death within 30 days was 3·0% (95% CI 2·4–3·9; 26 non-disabling strokes plus 34 disabling or fatal perioperative events in 1979 CEAs). Excluding perioperative events and non-stroke mortality, stroke risks (immediate vs deferred CEA) were 4·1% versus 10·0% at 5 years (gain 5·9%, 95% CI 4·0–7·8) and 10·8% versus 16·9% at 10 years (gain 6·1%, 2·7–9·4); ratio of stroke incidence rates 0·54, 95% CI 0·43–0·68, p

Published
2010
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48. Cardiovascular disease (CVD) markers in patients(pts) with prostate cancer(PCa) treated with GN-RH agonists(AG) or antagonist(AN): a prospective cohort study

Author

Cavo, A., primary, Rubagotti, A., additional, Bellodi, A., additional, Zanardi, E., additional, Zinoli, L., additional, Spallarossa, P., additional, Bagnato, P., additional, Pane, B., additional, Favorini, S., additional, Barra, S., additional, Arboscello, C., additional, Arboscello, E., additional, Palombo, D., additional, and Boccardo, F., additional

Published
2017
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49. Myostatin mediates abdominal aortic atherosclerosis progression by inducing vascular smooth muscle cell dysfunction and monocyte recruitment

Author

Verzola, D., primary, Milanesi, S., additional, Bertolotto, M., additional, Garibaldi, S., additional, Villaggio, B., additional, Brunelli, C., additional, Balbi, M., additional, Ameri, P., additional, Montecucco, F., additional, Palombo, D., additional, Ghigliotti, G., additional, Garibotto, G., additional, Lindeman, J. H., additional, and Barisione, C., additional

Published
2017
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