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4. Appendectomy during the COVID-19 pandemic in Italy: a multicenter ambispective cohort study by the Italian Society of Endoscopic Surgery and new technologies (the CRAC study)

Author

Sartori, A, Podda, M, Botteri, E, Passera, R, Agresta, F, Arezzo, A, Guerrieri, M, Ortenzi, M, Cavallo, F, Zese, M, Prando, D, Restini, E, Cianci, P, Millo, P, Brachet Contul, R, Serrao, A, Abatini, F, Altomare, D, Picciariello, A, Chetta, G, Lattanzio, F, Tonini, V, Gori, A, Jovine, E, Mastrangelo, L, Sartarelli, L, Frena, A, Malpaga, A, Bertelli, F, Pignata, G, Andreuccetti, J, Sanna, S, Lares, B, Sechi, R, Cillara, N, Pisanu, A, Delogu, D, Ciaccio, G, Farulla, M, Casati, M, Laface, L, De Luca, M, Russello, D, Latteri, S, Longoni, M, Masci, E, Vigna, S, Campanile, F, Foti, N, Lepiane, P, Balla, A, Cantore, F, Raveglia, V, Borghi, F, Giraudo, G, Verzelli, A, Budassi, A, Patriti, A, Foghetti, D, Montin, U, Amadio, L, Anania, G, Bombardini, C, Fabbri, N, Feo, C, Cianchi, F, Manetti, A, Lucchese, M, Soricelli, E, Ceccarelli, G, Patiti, M, Frascio, M, Stabilini, C, Filauro, M, Barberis, A, Troian, M, Nagliati, C, Campagnacci, R, Maurizi, A, Berti, S, Gennai, A, Marvaso, A, D'Antonio, D, Mazzola, L, Selvaggi, F, Carini, S, Costanzo, F, Boccia, L, Pascariello, A, Perrotta, N, Celiento, M, Opocher, E, Giovenzana, M, Stella, M, Ferrara, F, Boni, L, Abate, E, Da Lio, C, Valli, V, Gelmini, R, Serra, F, Piccoli, M, Gozzo, D, Gattolin, A, Sasia, D, Balani, A, Petronio, B, Calo, P, Canu, G, Contarini, E, Piatto, G, Vettoretto, N, Caprioli, M, Braga, M, Chiappetta, M, Maida, P, Tammaro, P, De Palma, G, Milone, M, Bottino, V, Canfora, A, Bagaglini, G, Agrusa, A, Barone, M, Mirabella, A, Marino, M, Gulotta, G, Romano, G, Sorrentino, M, Ferfoglia, S, Papagni, V, Eramo, S, Boselli, C, Basti, M, Caracino, V, Moretto, G, Inama, M, Capelli, P, Conti, L, Muratore, A, Cuoghi, M, Zerbinati, A, Corso, S, Vasino, M, Montuori, M, Fidanza, F, Lucchetta, A, Giuliani, A, Dinatale, G, Zanzi, F, Guariniello, A, Bonilauri, S, Frazzetta, G, Garino, M, Marafante, C, Gioffre, A, Del Monte, S, Sganga, G, Fransvea, P, Grande, M, Siragusa, L, Sica, G, Paola, M, Passantino, D, Catani, M, Ricci, F, Lauro, E, Facci, E, Parini, D, Armellino, M, Argenio, G, Porcu, A, Perra, T, Bordoni, P, Fleres, F, Parisi, A, Rossi, S, Saracco, R, Bono, D, Viora, T, Orlando, F, Ferrero, A, Fontana, A, De Paolis, P, Visconti, D, Quaglino, F, Festa, F, Palagi, S, Lo Secco, G, Morino, M, Allaix, M, Salzano, A, Tirone, G, Motter, M, Zanus, G, Passuello, N, Massani, M, Tutino, R, Manzini, N, Terranova, S, Merenda, R, Nordio, S, Zonta, S, Lovisetto, F, Guglielmi, A, Campagnaro, T, Amedeo, E, Scollica, M, Amodio, P, Giannotti, D, Olmi, S, Oldani, A, Sartori A., Podda M., Botteri E., Passera R., Agresta F., Arezzo A., Guerrieri M., Ortenzi M., Cavallo F., Zese M., Prando D., Restini E., Cianci P., Millo P., Brachet Contul R., Serrao A., Abatini F., Altomare D. F., Picciariello A., Chetta G., Lattanzio F., Tonini V., Gori A., Jovine E., Mastrangelo L., Sartarelli L., Frena A., Malpaga A., Bertelli F., Pignata G., Andreuccetti J., Sanna S., Lares B., Sechi R., Cillara N., Pisanu A., Delogu D., Ciaccio G., Farulla M., Casati M., Laface L., De Luca M., Russello D., Latteri S., Longoni M., Masci E., Vigna S., Campanile F. C., Foti N., Lepiane P., Balla A., Cantore F., Raveglia V., Borghi F., Giraudo G., Verzelli A., Budassi A., Patriti A., Foghetti D., Montin U., Amadio L., Anania G., Bombardini C., Fabbri N., Feo C., Cianchi F., Manetti A., Lucchese M., Soricelli E., Ceccarelli G., Patiti M., Frascio M., Stabilini C., Filauro M., Barberis A., Troian M., Nagliati C., Campagnacci R., Maurizi A., Berti S., Gennai A., Marvaso A., D'Antonio D., Feo C. V., Mazzola L., Selvaggi F., Carini S., Costanzo F., Boccia L., Pascariello A., Perrotta N., Celiento M., Opocher E., Giovenzana M., Stella M., Ferrara F., Boni L., Abate E., Da Lio C., Valli V., Gelmini R., Serra F., Piccoli M., Gozzo D., Gattolin A., Sasia D., Balani A., Petronio B., Calo P. G., Canu G. L., Contarini E., Piatto G., Vettoretto N., Caprioli M., Braga M., Chiappetta M. F., Maida P., Tammaro P., De Palma G., Milone M., Bottino V., Canfora A., Bagaglini G., Agrusa A., Barone M., Mirabella A., Marino M. V., Gulotta G., Romano G., Sorrentino M., Ferfoglia S., Papagni V., Eramo S., Boselli C., Basti M., Caracino V., Moretto G., Inama M., Capelli P., Conti L., Muratore A., Cuoghi M. M., Zerbinati A., Corso S., Vasino M. C., Montuori M., Fidanza F., Lucchetta A., Giuliani A., Dinatale G., Zanzi F., Guariniello A., Bonilauri S., Frazzetta G., Garino M., Marafante C., Gioffre A., Del Monte S. R., Sganga G., Fransvea P., Grande M., Siragusa L., Sica G., Paola M., Passantino D. G., Catani M., Ricci F., Lauro E., Facci E., Parini D., Armellino M. F., Argenio G., Porcu A., Perra T., Bordoni P., Fleres F., Parisi A., Rossi S., Saracco R., Bono D., Viora T., Orlando F., Ferrero A., Fontana A. P., De Paolis P., Visconti D., Quaglino F., Festa F., Palagi S., Lo Secco G., Morino M., Allaix M. E., Salzano A., Tirone G., Motter M., Zanus G., Passuello N., Massani M., Tutino R., Manzini N., Terranova S., Merenda R., Nordio S., Zonta S., Lovisetto F., Guglielmi A., Campagnaro T., Amedeo E., Scollica M., Amodio P., Giannotti D., Olmi S., Oldani A., Sartori, A, Podda, M, Botteri, E, Passera, R, Agresta, F, Arezzo, A, Guerrieri, M, Ortenzi, M, Cavallo, F, Zese, M, Prando, D, Restini, E, Cianci, P, Millo, P, Brachet Contul, R, Serrao, A, Abatini, F, Altomare, D, Picciariello, A, Chetta, G, Lattanzio, F, Tonini, V, Gori, A, Jovine, E, Mastrangelo, L, Sartarelli, L, Frena, A, Malpaga, A, Bertelli, F, Pignata, G, Andreuccetti, J, Sanna, S, Lares, B, Sechi, R, Cillara, N, Pisanu, A, Delogu, D, Ciaccio, G, Farulla, M, Casati, M, Laface, L, De Luca, M, Russello, D, Latteri, S, Longoni, M, Masci, E, Vigna, S, Campanile, F, Foti, N, Lepiane, P, Balla, A, Cantore, F, Raveglia, V, Borghi, F, Giraudo, G, Verzelli, A, Budassi, A, Patriti, A, Foghetti, D, Montin, U, Amadio, L, Anania, G, Bombardini, C, Fabbri, N, Feo, C, Cianchi, F, Manetti, A, Lucchese, M, Soricelli, E, Ceccarelli, G, Patiti, M, Frascio, M, Stabilini, C, Filauro, M, Barberis, A, Troian, M, Nagliati, C, Campagnacci, R, Maurizi, A, Berti, S, Gennai, A, Marvaso, A, D'Antonio, D, Mazzola, L, Selvaggi, F, Carini, S, Costanzo, F, Boccia, L, Pascariello, A, Perrotta, N, Celiento, M, Opocher, E, Giovenzana, M, Stella, M, Ferrara, F, Boni, L, Abate, E, Da Lio, C, Valli, V, Gelmini, R, Serra, F, Piccoli, M, Gozzo, D, Gattolin, A, Sasia, D, Balani, A, Petronio, B, Calo, P, Canu, G, Contarini, E, Piatto, G, Vettoretto, N, Caprioli, M, Braga, M, Chiappetta, M, Maida, P, Tammaro, P, De Palma, G, Milone, M, Bottino, V, Canfora, A, Bagaglini, G, Agrusa, A, Barone, M, Mirabella, A, Marino, M, Gulotta, G, Romano, G, Sorrentino, M, Ferfoglia, S, Papagni, V, Eramo, S, Boselli, C, Basti, M, Caracino, V, Moretto, G, Inama, M, Capelli, P, Conti, L, Muratore, A, Cuoghi, M, Zerbinati, A, Corso, S, Vasino, M, Montuori, M, Fidanza, F, Lucchetta, A, Giuliani, A, Dinatale, G, Zanzi, F, Guariniello, A, Bonilauri, S, Frazzetta, G, Garino, M, Marafante, C, Gioffre, A, Del Monte, S, Sganga, G, Fransvea, P, Grande, M, Siragusa, L, Sica, G, Paola, M, Passantino, D, Catani, M, Ricci, F, Lauro, E, Facci, E, Parini, D, Armellino, M, Argenio, G, Porcu, A, Perra, T, Bordoni, P, Fleres, F, Parisi, A, Rossi, S, Saracco, R, Bono, D, Viora, T, Orlando, F, Ferrero, A, Fontana, A, De Paolis, P, Visconti, D, Quaglino, F, Festa, F, Palagi, S, Lo Secco, G, Morino, M, Allaix, M, Salzano, A, Tirone, G, Motter, M, Zanus, G, Passuello, N, Massani, M, Tutino, R, Manzini, N, Terranova, S, Merenda, R, Nordio, S, Zonta, S, Lovisetto, F, Guglielmi, A, Campagnaro, T, Amedeo, E, Scollica, M, Amodio, P, Giannotti, D, Olmi, S, Oldani, A, Sartori A., Podda M., Botteri E., Passera R., Agresta F., Arezzo A., Guerrieri M., Ortenzi M., Cavallo F., Zese M., Prando D., Restini E., Cianci P., Millo P., Brachet Contul R., Serrao A., Abatini F., Altomare D. F., Picciariello A., Chetta G., Lattanzio F., Tonini V., Gori A., Jovine E., Mastrangelo L., Sartarelli L., Frena A., Malpaga A., Bertelli F., Pignata G., Andreuccetti J., Sanna S., Lares B., Sechi R., Cillara N., Pisanu A., Delogu D., Ciaccio G., Farulla M., Casati M., Laface L., De Luca M., Russello D., Latteri S., Longoni M., Masci E., Vigna S., Campanile F. C., Foti N., Lepiane P., Balla A., Cantore F., Raveglia V., Borghi F., Giraudo G., Verzelli A., Budassi A., Patriti A., Foghetti D., Montin U., Amadio L., Anania G., Bombardini C., Fabbri N., Feo C., Cianchi F., Manetti A., Lucchese M., Soricelli E., Ceccarelli G., Patiti M., Frascio M., Stabilini C., Filauro M., Barberis A., Troian M., Nagliati C., Campagnacci R., Maurizi A., Berti S., Gennai A., Marvaso A., D'Antonio D., Feo C. V., Mazzola L., Selvaggi F., Carini S., Costanzo F., Boccia L., Pascariello A., Perrotta N., Celiento M., Opocher E., Giovenzana M., Stella M., Ferrara F., Boni L., Abate E., Da Lio C., Valli V., Gelmini R., Serra F., Piccoli M., Gozzo D., Gattolin A., Sasia D., Balani A., Petronio B., Calo P. G., Canu G. L., Contarini E., Piatto G., Vettoretto N., Caprioli M., Braga M., Chiappetta M. F., Maida P., Tammaro P., De Palma G., Milone M., Bottino V., Canfora A., Bagaglini G., Agrusa A., Barone M., Mirabella A., Marino M. V., Gulotta G., Romano G., Sorrentino M., Ferfoglia S., Papagni V., Eramo S., Boselli C., Basti M., Caracino V., Moretto G., Inama M., Capelli P., Conti L., Muratore A., Cuoghi M. M., Zerbinati A., Corso S., Vasino M. C., Montuori M., Fidanza F., Lucchetta A., Giuliani A., Dinatale G., Zanzi F., Guariniello A., Bonilauri S., Frazzetta G., Garino M., Marafante C., Gioffre A., Del Monte S. R., Sganga G., Fransvea P., Grande M., Siragusa L., Sica G., Paola M., Passantino D. G., Catani M., Ricci F., Lauro E., Facci E., Parini D., Armellino M. F., Argenio G., Porcu A., Perra T., Bordoni P., Fleres F., Parisi A., Rossi S., Saracco R., Bono D., Viora T., Orlando F., Ferrero A., Fontana A. P., De Paolis P., Visconti D., Quaglino F., Festa F., Palagi S., Lo Secco G., Morino M., Allaix M. E., Salzano A., Tirone G., Motter M., Zanus G., Passuello N., Massani M., Tutino R., Manzini N., Terranova S., Merenda R., Nordio S., Zonta S., Lovisetto F., Guglielmi A., Campagnaro T., Amedeo E., Scollica M., Amodio P., Giannotti D., Olmi S., and Oldani A.

Abstract

Major surgical societies advised using non-operative management of appendicitis and suggested against laparoscopy during the COVID-19 pandemic. The hypothesis is that a significant reduction in the number of emergent appendectomies was observed during the pandemic, restricted to complex cases. The study aimed to analyse emergent surgical appendectomies during pandemic on a national basis and compare it to the same period of the previous year. This is a multicentre, retrospective, observational study investigating the outcomes of patients undergoing emergent appendectomy in March–April 2019 vs March–April 2020. The primary outcome was the number of appendectomies performed, classified according to the American Association for the Surgery of Trauma (AAST) score. Secondary outcomes were the type of surgical technique employed (laparoscopic vs open) and the complication rates. One thousand five hundred forty one patients with acute appendicitis underwent surgery during the two study periods. 1337 (86.8%) patients met the inclusion criteria: 546 (40.8%) patients underwent surgery for acute appendicitis in 2020 and 791 (59.2%) in 2019. According to AAST, patients with complicated appendicitis operated in 2019 were 30.3% vs 39.9% in 2020 (p = 0.001). We observed an increase in the number of post-operative complications in 2020 (15.9%) compared to 2019 (9.6%) (p < 0.001). The following determinants increased the likelihood of complication occurrence: undergoing surgery during 2020 (+ 67%), the increase of a unit in the AAST score (+ 26%), surgery performed > 24 h after admission (+ 58%), open surgery (+ 112%) and conversion to open surgery (+ 166%). In Italian hospitals, in March and April 2020, the number of appendectomies has drastically dropped. During the first pandemic wave, patients undergoing surgery were more frequently affected by more severe appendicitis than the previous year's timeframe and experienced a higher number of complications. Trial registrat

Published
2021

5. Appendectomy during the COVID-19 pandemic in Italy: a multicenter ambispective cohort study by the Italian Society of Endoscopic Surgery and new technologies (the CRAC study)

Author

Sartori A., Podda M., Botteri E., Passera R., Agresta F., Arezzo A., Guerrieri M., Ortenzi M., Cavallo F., Zese M., Prando D., Restini E., Cianci P., Millo P., Brachet Contul R., Serrao A., Abatini F., Altomare D. F., Picciariello A., Chetta G., Lattanzio F., Tonini V., Gori A., Jovine E., Mastrangelo L., Sartarelli L., Frena A., Malpaga A., Bertelli F., Pignata G., Andreuccetti J., Sanna S., Lares B., Sechi R., Cillara N., Pisanu A., Delogu D., Ciaccio G., Farulla M., Casati M., Laface L., De Luca M., Russello D., Latteri S., Longoni M., Masci E., Vigna S., Campanile F. C., Foti N., Lepiane P., Balla A., Cantore F., Raveglia V., Borghi F., Giraudo G., Verzelli A., Budassi A., Patriti A., Foghetti D., Montin U., Amadio L., Anania G., Bombardini C., Fabbri N., Feo C., Cianchi F., Manetti A., Lucchese M., Soricelli E., Ceccarelli G., Patiti M., Frascio M., Stabilini C., Filauro M., Barberis A., Troian M., Nagliati C., Campagnacci R., Maurizi A., Berti S., Gennai A., Marvaso A., D'Antonio D., Feo C. V., Mazzola L., Selvaggi F., Carini S., Costanzo F., Boccia L., Pascariello A., Perrotta N., Celiento M., Opocher E., Giovenzana M., Stella M., Ferrara F., Boni L., Abate E., Da Lio C., Valli V., Gelmini R., Serra F., Piccoli M., Gozzo D., Gattolin A., Sasia D., Balani A., Petronio B., Calo P. G., Canu G. L., Contarini E., Piatto G., Vettoretto N., Caprioli M., Braga M., Chiappetta M. F., Maida P., Tammaro P., De Palma G., Milone M., Bottino V., Canfora A., Bagaglini G., Agrusa A., Barone M., Mirabella A., Marino M. V., Gulotta G., Romano G., Sorrentino M., Ferfoglia S., Papagni V., Eramo S., Boselli C., Basti M., Caracino V., Moretto G., Inama M., Capelli P., Conti L., Muratore A., Cuoghi M. M., Zerbinati A., Corso S., Vasino M. C., Montuori M., Fidanza F., Lucchetta A., Giuliani A., Dinatale G., Zanzi F., Guariniello A., Bonilauri S., Frazzetta G., Garino M., Marafante C., Gioffre A., Del Monte S. R., Sganga G., Fransvea P., Grande M., Siragusa L., Sica G., Paola M., Passantino D. G., Catani M., Ricci F., Lauro E., Facci E., Parini D., Armellino M. F., Argenio G., Porcu A., Perra T., Bordoni P., Fleres F., Parisi A., Rossi S., Saracco R., Bono D., Viora T., Orlando F., Ferrero A., Fontana A. P., De Paolis P., Visconti D., Quaglino F., Festa F., Palagi S., Lo Secco G., Morino M., Allaix M. E., Salzano A., Tirone G., Motter M., Zanus G., Passuello N., Massani M., Tutino R., Manzini N., Terranova S., Merenda R., Nordio S., Zonta S., Lovisetto F., Guglielmi A., Campagnaro T., Amedeo E., Scollica M., Amodio P., Giannotti D., Olmi S., Oldani A., Sartori, A., Podda, M., Botteri, E., Passera, R., Agresta, F., Arezzo, A., Guerrieri, M., Ortenzi, M., Cavallo, F., Zese, M., Prando, D., Restini, E., Cianci, P., Millo, P., Brachet Contul, R., Serrao, A., Abatini, F., Altomare, D. F., Picciariello, A., Chetta, G., Lattanzio, F., Tonini, V., Gori, A., Jovine, E., Mastrangelo, L., Sartarelli, L., Frena, A., Malpaga, A., Bertelli, F., Pignata, G., Andreuccetti, J., Sanna, S., Lares, B., Sechi, R., Cillara, N., Pisanu, A., Delogu, D., Ciaccio, G., Farulla, M., Casati, M., Laface, L., De Luca, M., Russello, D., Latteri, S., Longoni, M., Masci, E., Vigna, S., Campanile, F. C., Foti, N., Lepiane, P., Balla, A., Cantore, F., Raveglia, V., Borghi, F., Giraudo, G., Verzelli, A., Budassi, A., Patriti, A., Foghetti, D., Montin, U., Amadio, L., Anania, G., Bombardini, C., Fabbri, N., Feo, C., Cianchi, F., Manetti, A., Lucchese, M., Soricelli, E., Ceccarelli, G., Patiti, M., Frascio, M., Stabilini, C., Filauro, M., Barberis, A., Troian, M., Nagliati, C., Campagnacci, R., Maurizi, A., Berti, S., Gennai, A., Marvaso, A., D'Antonio, D., Feo, C. V., Mazzola, L., Selvaggi, F., Carini, S., Costanzo, F., Boccia, L., Pascariello, A., Perrotta, N., Celiento, M., Opocher, E., Giovenzana, M., Stella, M., Ferrara, F., Boni, L., Abate, E., Da Lio, C., Valli, V., Gelmini, R., Serra, F., Piccoli, M., Gozzo, D., Gattolin, A., Sasia, D., Balani, A., Petronio, B., Calo, P. G., Canu, G. L., Contarini, E., Piatto, G., Vettoretto, N., Caprioli, M., Braga, M., Chiappetta, M. F., Maida, P., Tammaro, P., De Palma, G., Milone, M., Bottino, V., Canfora, A., Bagaglini, G., Agrusa, A., Barone, M., Mirabella, A., Marino, M. V., Gulotta, G., Romano, G., Sorrentino, M., Ferfoglia, S., Papagni, V., Eramo, S., Boselli, C., Basti, M., Caracino, V., Moretto, G., Inama, M., Capelli, P., Conti, L., Muratore, A., Cuoghi, M. M., Zerbinati, A., Corso, S., Vasino, M. C., Montuori, M., Fidanza, F., Lucchetta, A., Giuliani, A., Dinatale, G., Zanzi, F., Guariniello, A., Bonilauri, S., Frazzetta, G., Garino, M., Marafante, C., Gioffre, A., Del Monte, S. R., Sganga, G., Fransvea, P., Grande, M., Siragusa, L., Sica, G., Paola, M., Passantino, D. G., Catani, M., Ricci, F., Lauro, E., Facci, E., Parini, D., Armellino, M. F., Argenio, G., Porcu, A., Perra, T., Bordoni, P., Fleres, F., Parisi, A., Rossi, S., Saracco, R., Bono, D., Viora, T., Orlando, F., Ferrero, A., Fontana, A. P., De Paolis, P., Visconti, D., Quaglino, F., Festa, F., Palagi, S., Lo Secco, G., Morino, M., Allaix, M. E., Salzano, A., Tirone, G., Motter, M., Zanus, G., Passuello, N., Massani, M., Tutino, R., Manzini, N., Terranova, S., Merenda, R., Nordio, S., Zonta, S., Lovisetto, F., Guglielmi, A., Campagnaro, T., Amedeo, E., Scollica, M., Amodio, P., Giannotti, D., Olmi, S., Oldani, A., Sartori A., Podda M., Botteri E., Passera R., Agresta F., Arezzo A., Guerrieri M., Ortenzi M., Cavallo F., Zese M., Prando D., Restini E., Cianci P., Millo P., Brachet Contul R., Serrao A., Abatini F., Altomare D.F., Picciariello A., Chetta G., Lattanzio F., Tonini V., Gori A., Jovine E., Mastrangelo L., Sartarelli L., Frena A., Malpaga A., Bertelli F., Pignata G., Andreuccetti J., Sanna S., Lares B., Sechi R., Cillara N., Pisanu A., Delogu D., Ciaccio G., Farulla M., Casati M., Laface L., De Luca M., Russello D., Latteri S., Longoni M., Masci E., Vigna S., Campanile F.C., Foti N., Lepiane P., Balla A., Cantore F., Raveglia V., Borghi F., Giraudo G., Verzelli A., Budassi A., Patriti A., Foghetti D., Montin U., Amadio L., Anania G., Bombardini C., Fabbri N., Feo C., Cianchi F., Manetti A., Lucchese M., Soricelli E., Ceccarelli G., Patiti M., Frascio M., Stabilini C., Filauro M., Barberis A., Troian M., Nagliati C., Campagnacci R., Maurizi A., Berti S., Gennai A., Marvaso A., D'Antonio D., Feo C.V., Mazzola L., Selvaggi F., Carini S., Costanzo F., Boccia L., Pascariello A., Perrotta N., Celiento M., Opocher E., Giovenzana M., Stella M., Ferrara F., Boni L., Abate E., Da Lio C., Valli V., Gelmini R., Serra F., Piccoli M., Gozzo D., Gattolin A., Sasia D., Balani A., Petronio B., Calo P.G., Canu G.L., Contarini E., Piatto G., Vettoretto N., Caprioli M., Braga M., Chiappetta M.F., Maida P., Tammaro P., De Palma G., Milone M., Bottino V., Canfora A., Bagaglini G., Agrusa A., Barone M., Mirabella A., Marino M.V., Gulotta G., Romano G., Sorrentino M., Ferfoglia S., Papagni V., Eramo S., Boselli C., Basti M., Caracino V., Moretto G., Inama M., Capelli P., Conti L., Muratore A., Cuoghi M.M., Zerbinati A., Corso S., Vasino M.C., Montuori M., Fidanza F., Lucchetta A., Giuliani A., Dinatale G., Zanzi F., Guariniello A., Bonilauri S., Frazzetta G., Garino M., Marafante C., Gioffre A., Del Monte S.R., Sganga G., Fransvea P., Grande M., Siragusa L., Sica G., Paola M., Passantino D.G., Catani M., Ricci F., Lauro E., Facci E., Parini D., Armellino M.F., Argenio G., Porcu A., Perra T., Bordoni P., Fleres F., Parisi A., Rossi S., Saracco R., Bono D., Viora T., Orlando F., Ferrero A., Fontana A.P., De Paolis P., Visconti D., Quaglino F., Festa F., Palagi S., Lo Secco G., Morino M., Allaix M.E., Salzano A., Tirone G., Motter M., Zanus G., Passuello N., Massani M., Tutino R., Manzini N., Terranova S., Merenda R., Nordio S., Zonta S., Lovisetto F., Guglielmi A., Campagnaro T., Amedeo E., Scollica M., Amodio P., Giannotti D., Olmi S., Oldani A., Sartori, Alberto, Podda, Mauro, Botteri, Emanuele, Passera, Roberto, Agresta, Ferdinando, Arezzo, Alberto, M Guerrieri, M Ortenzi, F Cavallo, M Zese, D Prando, E Restini, P Cianci, P Millo, R Brachet Contul, A Serrao, F Abatini, D F Altomare, A Picciariello, G Chetta, F Lattanzio, V Tonini, A Gori, E Jovine, L Mastrangelo, L Sartarelli, A Frena, A Malpaga, F Bertelli, G Pignata, J Andreuccetti, S Sanna, B Lares, R Sechi, N Cillara, A Pisanu, D Delogu, G Ciaccio, M Farulla, M Casati, L Laface, M De Luca, D Russello, S Latteri, M Longoni, E Masci, S Vigna, F C Campanile, N Foti, P Lepiane, A Balla, F Cantore, V Raveglia, F Borghi, G Giraudo, A Verzelli, A Budassi, A Patriti, D Foghetti, U Montin, L Amadio, G Anania, C Bombardini, Niccolò Fabbri, Carlo Feo, F Cianchi, A Manetti, M Lucchese, E Soricelli, G Ceccarelli, M Patiti, M Frascio, C Stabilini, M Filauro, A Barberis, M Troian, C Nagliati, R Campagnacci, A Maurizi, S Berti, A Gennai, A Marvaso, D D'Antonio, C V Feo, N Fabbri, L Mazzola, F Selvaggi, S Carini, F Costanzo, L Boccia, A Pascariello, N Perrotta, M Celiento, E Opocher, M Giovenzana, M Stella, F Ferrara, L Boni, E Abate, C Da Lio, V Valli, R Gelmini, F Serra, M Piccoli, D Gozzo, A Gattolin, D Sasia, A Balani, B Petronio, P G Calò, G L Canu, E Contarini, G Piatto, N Vettoretto, M Caprioli, M Braga, M F Chiappetta, P Maida, P Tammaro, G De Palma, M Milone, V Bottino, A Canfora, F Selvaggi, G Bagaglini, A Agrusa, M Barone, A Mirabella, M V Marino, G Gulotta, G Romano, M Sorrentino, S Ferfoglia, V Papagni, S Eramo, C Boselli, M Basti, V Caracino, G Moretto, M Inama, P Capelli, L Conti, A Muratore, M M Cuoghi, A Zerbinati, S Corso, M C Vasino, M Montuori, F Fidanza, A Lucchetta, A Giuliani, G Dinatale, F Zanzi, A Guariniello, S Bonilauri, G Frazzetta, M Garino, C Marafante, A Gioffrè, S R Del Monte, G Sganga, P Fransvea, M Grande, L Siragusa, G Sica, M Paola, D G Passantino, Marco Catani, F Ricci, E Lauro, E Facci, D Parini, M F Armellino, G Argenio, A Porcu, T Perra, P Bordoni, F Fleres, A Parisi, S Rossi, R Saracco, D Bono, T Viora, F Orlando, A Ferrero, A P Fontana, P De Paolis, D Visconti, F Quaglino, F Festa, S Palagi, G Lo Secco, M Morino, M E Allaix, A Salzano, G Tirone, M Motter, G Zanus, N Passuello, M Massani, R Tutino, N Manzini, S Terranova, R Merenda, S Nordio, S Zonta, F Lovisetto, A Guglielmi, T Campagnaro, E Amedeo, M Scollica, P Amodio, D Giannotti, S Olmi, A Oldani, Sartori, A, Podda, M, Botteri, E, Passera, R, Agresta, F, Arezzo, A, Guerrieri, M, Ortenzi, M, Cavallo, F, Zese, M, Prando, D, Restini, E, Cianci, P, Millo, P, Brachet Contul, R, Serrao, A, Abatini, F, Altomare, D, Picciariello, A, Chetta, G, Lattanzio, F, Tonini, V, Gori, A, Jovine, E, Mastrangelo, L, Sartarelli, L, Frena, A, Malpaga, A, Bertelli, F, Pignata, G, Andreuccetti, J, Sanna, S, Lares, B, Sechi, R, Cillara, N, Pisanu, A, Delogu, D, Ciaccio, G, Farulla, M, Casati, M, Laface, L, De Luca, M, Russello, D, Latteri, S, Longoni, M, Masci, E, Vigna, S, Campanile, F, Foti, N, Lepiane, P, Balla, A, Cantore, F, Raveglia, V, Borghi, F, Giraudo, G, Verzelli, A, Budassi, A, Patriti, A, Foghetti, D, Montin, U, Amadio, L, Anania, G, Bombardini, C, Fabbri, N, Feo, C, Cianchi, F, Manetti, A, Lucchese, M, Soricelli, E, Ceccarelli, G, Patiti, M, Frascio, M, Stabilini, C, Filauro, M, Barberis, A, Troian, M, Nagliati, C, Campagnacci, R, Maurizi, A, Berti, S, Gennai, A, Marvaso, A, D'Antonio, D, Mazzola, L, Selvaggi, F, Carini, S, Costanzo, F, Boccia, L, Pascariello, A, Perrotta, N, Celiento, M, Opocher, E, Giovenzana, M, Stella, M, Ferrara, F, Boni, L, Abate, E, Da Lio, C, Valli, V, Gelmini, R, Serra, F, Piccoli, M, Gozzo, D, Gattolin, A, Sasia, D, Balani, A, Petronio, B, Calo, P, Canu, G, Contarini, E, Piatto, G, Vettoretto, N, Caprioli, M, Braga, M, Chiappetta, M, Maida, P, Tammaro, P, De Palma, G, Milone, M, Bottino, V, Canfora, A, Bagaglini, G, Agrusa, A, Barone, M, Mirabella, A, Marino, M, Gulotta, G, Romano, G, Sorrentino, M, Ferfoglia, S, Papagni, V, Eramo, S, Boselli, C, Basti, M, Caracino, V, Moretto, G, Inama, M, Capelli, P, Conti, L, Muratore, A, Cuoghi, M, Zerbinati, A, Corso, S, Vasino, M, Montuori, M, Fidanza, F, Lucchetta, A, Giuliani, A, Dinatale, G, Zanzi, F, Guariniello, A, Bonilauri, S, Frazzetta, G, Garino, M, Marafante, C, Gioffre, A, Del Monte, S, Sganga, G, Fransvea, P, Grande, M, Siragusa, L, Sica, G, Paola, M, Passantino, D, Catani, M, Ricci, F, Lauro, E, Facci, E, Parini, D, Armellino, M, Argenio, G, Porcu, A, Perra, T, Bordoni, P, Fleres, F, Parisi, A, Rossi, S, Saracco, R, Bono, D, Viora, T, Orlando, F, Ferrero, A, Fontana, A, De Paolis, P, Visconti, D, Quaglino, F, Festa, F, Palagi, S, Lo Secco, G, Morino, M, Allaix, M, Salzano, A, Tirone, G, Motter, M, Zanus, G, Passuello, N, Massani, M, Tutino, R, Manzini, N, Terranova, S, Merenda, R, Nordio, S, Zonta, S, Lovisetto, F, Guglielmi, A, Campagnaro, T, Amedeo, E, Scollica, M, Amodio, P, Giannotti, D, Olmi, S, and Oldani, A

Subjects
medicine.medical_specialty, COVID-19 Pandemic, Coronavirus disease 2019 (COVID-19), Endoscopic surgery, NO, Appendectomy, Appendicitis, Machine learning, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, Retrospective Studie, Pandemic, medicine, Humans, Appendiciti, Laparoscopy, Pandemics, Retrospective Studies, medicine.diagnostic_test, business.industry, COVID-19 Pandemic, Appendicitis, Appendicectomy, Machine learning, SARS-CoV-2, COVID-19, Length of Stay, medicine.disease, Settore MED/18, Surgery, Italy, 030220 oncology & carcinogenesis, appendicitis, COVID-19 pandemic, machine learning, appendectomy, cohort studies, humans, length of stay, pandemics, postoperative complications, retrospective studies, laparoscopy, 030211 gastroenterology & hepatology, Observational study, Original Article, Postoperative Complication, Appendicectomy, Cohort Studie, business, Complication, Cohort study, Human
Abstract

Major surgical societies advised using non-operative management of appendicitis and suggested against laparoscopy during the COVID-19 pandemic. The hypothesis is that a significant reduction in the number of emergent appendectomies was observed during the pandemic, restricted to complex cases. The study aimed to analyse emergent surgical appendectomies during pandemic on a national basis and compare it to the same period of the previous year. This is a multicentre, retrospective, observational study investigating the outcomes of patients undergoing emergent appendectomy in March–April 2019 vs March–April 2020. The primary outcome was the number of appendectomies performed, classified according to the American Association for the Surgery of Trauma (AAST) score. Secondary outcomes were the type of surgical technique employed (laparoscopic vs open) and the complication rates. One thousand five hundred forty one patients with acute appendicitis underwent surgery during the two study periods. 1337 (86.8%) patients met the inclusion criteria: 546 (40.8%) patients underwent surgery for acute appendicitis in 2020 and 791 (59.2%) in 2019. According to AAST, patients with complicated appendicitis operated in 2019 were 30.3% vs 39.9% in 2020 (p = 0.001). We observed an increase in the number of post-operative complications in 2020 (15.9%) compared to 2019 (9.6%) (p 24 h after admission (+ 58%), open surgery (+ 112%) and conversion to open surgery (+ 166%). In Italian hospitals, in March and April 2020, the number of appendectomies has drastically dropped. During the first pandemic wave, patients undergoing surgery were more frequently affected by more severe appendicitis than the previous year's timeframe and experienced a higher number of complications. Trial registration number and date: Research Registry ID 5789, May 7th, 2020

Published
2021

9. Free interactive mobile app with 3D‐reconstructed virtual models of congenital heart disease for prenatal parental counseling.

Author

Bertelli, F., Guariento, A., Gervasi, M. T., Galliotto, F., Sirico, D., Blitzer, D., Veronese, P., and Vida, V. L.

Subjects
*CONGENITAL heart disease, *MOBILE apps, *PHYSICAL fitness mobile apps, *PRENATAL diagnosis, *FETAL heart, *COUNSELING, *MEDICAL software
Abstract

Congenital heart disease (CHD) refers to abnormalities in the structure of the heart or great vessels that arise before birth. To our knowledge, this is the first app to show the full spectrum of CHD, including fetal CHD, using 3D virtual heart models produced from imaging of real patients. The recent advancement and popularization of four-dimensional (4D) US have made it possible to create and manipulate digital heart models of complex heart lesions from US imaging data obtained throughout the fetal heart cycle. [Extracted from the article]

Published
2023
Full Text
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11. Risk of low bone density in women attending menopause clinics in Italy

Author

DE ALOYSIO, D, DI DONATO, P, Giulini, Na, Modena, B, Cicchetti, G, Comitini, G, Gentile, G, Cristiani, P, Careccia, A, Esposito, E, Gigli, C, Mandruzzato, G, Petraglia, F, Bertelli, F, DEL FRATE, G, Garofalo, S, Marino, L, Costa, Mr, Quaranta, S, Bossi, Cm, Amantea, P, Omodei, U, Vaccari, M, Luerti, M, Repetti, F, Zandonini, G, Raspagliesi, F, Dolci, F, Zacchi, V, Bennici, S, Polizzotti, G, Bottino, S, Raffaelli, F, Minervini, C, Colombo, D, Belloni, C, Viani, A, Cecchini, G, Winkler, S, Samaja, Ba, Pasinetti, E, Penotti, M, Malanetto, C, Massobrio, M, Campagnoli, C, Dolfin, G, Tartaglino, P, Mossotto, D, Pesando, P, Pacilli, L, Rattazzi, Pd, Arisi, E, Gamper, M, Salvatores, D, Bocchin, E, Stellin, G, Meli, G, Azzini, V, Tirozzi, F, Buoso, G, Fraioli, R, Marsoni, V, Cetera, C, Sposetti, R, Bellati, U, Angeloni, C, Buonerba, M, Garzarelli, S, Santilli, C, Mucci, M, DI NISIO, Q, Falasca, L, Ferrante, D, Cirese, E, Todaro, Pa, Romanini, C, Spagnuolo, L, Lanzone, A, Donadio, C, Fabiani, M, Baldaccini, E, Votano, S, Serra, Gb, Bellardini, P, Massacesi, L, Donini, G, Genazzani, Ra, Scarselli, G, Curiel, P, DE LEO, V, Melani, A, D'Ancona, Vl, Giarre, G, DI GIOIA, E, Ciccarelli, P, Sarti, Cd, Balsotti, G, Pupita, P, Mincigrucci, M, Spadafora, A, Santeufemia, G, D'Andrea, A, Chiantera, A, Montemagno, U, Staiano, S, Arienzo, R, Pastore, Ar, Tamburrino, A, Colacurci, A, Izzo, S, Zumpano, N, Pascarella, A, DE SILVIO MG, DI PRISCO, L, Lauda, N, Sorrentino, O, Agrimi, C, Casarella, G, Pisaturo, G, Senatore, G, Ruccia, G, Fasolino, A, Tropea, P, Stigliano, Cm, Giannice, C, Vadala, P, Coco, A, Lombardo, R, Barese, G, Masciari, G, Pirillo, P, Gioffre, T, Ferruccio, C, Agostinelli, D, Tonti, Gc, Scopelliti, A, Schonauer, S, Bongiovanni, F, Tinelli, F, Poddi, Er, Scarpello, F, Colonna, L, Fischetti, G, Doria, R, Trombetta, G, Cocca, Eb, Carone, D, Nocera, F, Giambanco, V, Giannola, C, Graziano, R, Mezzatesta, M, Vegna, G, Giannone, G, Palumbo, G, Cancellieri, Francesco, Mondo, A, Cordopatri, A, Carrubba, M, Mazzola, V, Ettore, G, D'Asta, S, DI LIBERTO, P, Massacesi, A, DE ALOYSIO, P, Ognissanti, F, Gambacciani, A, Graziottin, A, Baldi, C, Colacurci, N, and Parazzini, F.

Published
2002

12. General and medical factors associated with hormone replacement therapy among women attending menopause clinics in Italy

Author

DE ALOYSIO, D, DI DONATO, P, Giulini, Na, Modena, B, Cicchetti, G, Comitini, G, Gentile, G, Cristiani, P, Careccia, A, Esposito, E, Gigli, C, Mandruzzato, G, Petraglia, F, Bertelli, F, DEL FRATE, G, Garofalo, S, Marino, L, Costa, Mr, Quaranta, S, Bossi, Cm, Amantea, P, Omodei, U, Vaccari, M, Luerti, M, Repetti, F, Zandonini, G, Raspagliesi, F, Dolci, F, Zacchi, V, Bennici, S, Polizzotti, G, Bottino, S, Raffaelli, F, Minervini, C, Colombo, D, Belloni, C, Viani, A, Cecchini, G, Winkler, S, Samaja, Ba, Pasinetti, E, Penotti, M, Malanetto, C, Massobrio, M, Campagnoli, C, Dolfin, G, Tartaglino, P, Mossotto, D, Pesando, P, Pacilli, L, Rattazzi, Pd, Arisi, E, Gamper, M, Salvatores, D, Bocchin, E, Stellin, G, Meli, G, Azzini, V, Tirozzi, F, Buoso, G, Fraioli, R, Marsoni, V, Cetera, C, Sposetti, R, Bellati, U, Angeloni, C, Buonerba, M, Garzarelli, S, Santilli, C, Mucci, M, DI NISIO, Q, Falasca, L, Ferrante, D, Cirese, E, Todaro, Pa, Romanini, C, Spagnuolo, L, Lanzone, A, Donadio, C, Fabiani, M, Baldaccini, E, Votano, S, Serra, Gb, Bellardini, P, Massacesi, L, Donini, G, Genazzani, Ra, Scarselli, G, Curiel, P, DE LEO, V, Melani, A, D'Ancona, Vl, Giarre, G, DI GIOIA, E, Ciccarelli, P, Sarti, Cd, Balsotti, G, Pupita, P, Mincigrucci, M, Spadafora, A, Santeufemia, G, D'Andrea, A, Chiantera, A, Montemagno, U, Staiano, S, Arienzo, R, Pastore, Ar, Tamburrino, A, Colacurci, A, Izzo, S, Zumpano, N, Pascarella, A, DE SILVIO MG, DI PRISCO, L, Lauda, N, Sorrentino, O, Agrimi, C, Casarella, G, Pisaturo, G, Senatore, G, Ruccia, G, Fasolino, A, Tropea, P, Stigliano, Cm, Giannice, C, Vadala, P, Coco, A, Lombardo, R, Barese, G, Masciari, G, Pirillo, P, Gioffre, T, Ferruccio, C, Agostinelli, D, Tonti, Gc, Scopelliti, A, Schonauer, S, Bongiovanni, F, Tinelli, F, Poddi, Er, Scarpello, F, Colonna, L, Fischetti, G, Doria, R, Trombetta, G, Cocca, Eb, Carone, D, Nocera, F, Giambanco, V, Giannola, C, Graziano, R, Mezzatesta, M, Vegna, G, Giannone, G, Palumbo, G, Cancellieri, Francesco, Mondo, A, Cordopatri, A, Carrubba, M, Mazzola, V, Ettore, G, D'Asta, S, DI LIBERTO, P, Massacesi, A, DE ALOYSIO, P, Ognissanti, F, Gambacciani, A, Graziottin, A, Baldi, C, Colacurci, N, Parazzini, F, Chatenoud, L, and Chiaffarino, F.

Published
2001

13. Determinants of hysterectomy and oophorectomy in women attending menopause clinics in Italy

Author

DE ALOYSIO, D, DI DONATO, P, Giulini, Na, Modena, B, Cicchetti, G, Comitini, G, Gentile, G, Cristiani, P, Careccia, A, Esposito, E, Gigli, C, Mandruzzato, G, Petraglia, F, Bertelli, F, DEL FRATE, G, Garofalo, S, Marino, L, Costa, Mr, Quaranta, S, Bossi, Cm, Amantea, P, Omodei, U, Vaccari, M, Luerti, M, Repetti, F, Zandonini, G, Raspagliesi, F, Dolci, F, Zacchi, V, Bennici, S, Polizzotti, G, Bottino, S, Raffaelli, F, Minervini, C, Colombo, D, Belloni, C, Viani, A, Cecchini, G, Winkler, S, Samaja, Ba, Pasinetti, E, Penotti, M, Malanetto, C, Massobrio, M, Campagnoli, C, Dolfin, G, Tartaglino, P, Mossotto, D, Pesando, P, Pacilli, L, Rattazzi, Pd, Arisi, E, Gamper, M, Salvatores, D, Bocchin, E, Stellin, G, Meli, G, Azzini, V, Tirozzi, F, Buoso, G, Fraioli, R, Marsoni, V, Cetera, C, Sposetti, R, Bellati, U, Angeloni, C, Buonerba, M, Garzarelli, S, Santilli, C, Mucci, M, DI NISIO, Q, Falasca, L, Ferrante, D, Cirese, E, Todaro, Pa, Romanini, C, Spagnuolo, L, Lanzone, A, Donadio, C, Fabiani, M, Baldaccini, E, Votano, S, Serra, Gb, Bellardini, P, Massacesi, L, Donini, G, Genazzani, Ra, Scarselli, G, Curiel, P, DE LEO, V, Melani, A, D'Ancona, Vl, Giarre, G, DI GIOIA, E, Ciccarelli, P, Sarti, Cd, Balsotti, G, Pupita, P, Mincigrucci, M, Spadafora, A, Santeufemia, G, D'Andrea, A, Chiantera, A, Montemagno, U, Staiano, S, Arienzo, R, Pastore, Ar, Tamburrino, A, Colacurci, A, Izzo, S, Zumpano, N, Pascarella, A, DE SILVIO MG, DI PRISCO, L, Lauda, N, Sorrentino, O, Agrimi, C, Casarella, G, Pisaturo, G, Senatore, G, Ruccia, G, Fasolino, A, Tropea, P, Stigliano, Cm, Giannice, C, Vadala, P, Coco, A, Lombardo, R, Barese, G, Masciari, G, Pirillo, P, Gioffre, T, Ferruccio, C, Agostinelli, D, Tonti, Gc, Scopelliti, A, Schonauer, S, Bongiovanni, F, Tinelli, F, Poddi, Er, Scarpello, F, Colonna, L, Fischetti, G, Doria, R, Trombetta, G, Cocca, Eb, Carone, D, Nocera, F, Giambanco, V, Giannola, C, Graziano, R, Mezzatesta, M, Vegna, G, Giannone, G, Palumbo, G, Cancellieri, Francesco, Mondo, A, Cordopatri, A, Carrubba, M, Mazzola, V, Ettore, G, D'Asta, S, DI LIBERTO, P, Angeloni, D'Andrea, Stigliano, Arienzo, Donato, Di, Giulini, Gigli, Ricci, Marino, Luerti, Donini, Dolfin, Poddi, Santeufemia, Nocera, Melani, Messini, Mincigrucci, Salvatores, Bocchin, Massacesi, A, DE ALOYSIO, P, Ognissanti, F, Gambacciani, A, Graziottin, A, Baldi, C, Parazzini, F, Chatenoud, L, and Chiaffarino, F.

Published
2000

18. General and medical factors associated with hormone replacement therapy among women attending menopause clinics in Italy

Author

Aloysio, D., Di Donato, P., Giulini, N. A., Modena, B., Cicchetti, G., Comitini, G., Gentile, G., Cristiani, P., Careccia, A., Esposito, E., Gigli, C., Mandruzzato, G., Petraglia, F., Bertelli, F., Del Frate, G., Garofalo, S., Marino, L., Costa, M. R., Qaranta, S., Bossi, C. M., Amantea, P., Omodei, U., Vaccari, M., Luerti, M., Repetti, F., Zandonini, G., Raspagliesi, F., Dolci, F., Zacchi, V., Bennici, S., Polizzotti, G., Bottino, S., Raffaelli, F., Minervini, C., Colombo, D., Belloni, C., Viani, A., Cecchini, G., Winkler, S., Samaja, B. A., Pasinetti, E., Penotti, M., Malanetto, C., Massobrio, M., Campagnoli, C., Dolfin, G., Tartaglino, P., Mossotto, D., Pesando, P., Pacilli, L., Rattazzi, P. D., Arisi, E., Gamper, M., Salvatores, D., Bocchin, E., Stellin, G., Meli, G., Azzini, V., Tirozzi, F., Buoso, G., Fraioli, R., Marsoni, V., Cetera, C., Sposetti, R., Bellati, U., Angeloni, C., Buonerba, M., Garzarelli, S., Santilli, C., Mucci, M., Di Nisio, Q., Falasca, L., Ferrante, D., Cirese, E., Todaro, P. A., Romanini, C., Spagnuolo, L., Lanzone, A., Donadio, C., Fabiani, M., Baldaccini, E., Votano, S., Serra, G. B., Bellardini, P., Massacesi, L., Donini, G., Genazzani, R. A., Scarselli, G., Curiel, P., Vincenzo De Leo, Melani, A., Levi D Ancona, V., Giarrè, G., Di Gioia, E., Ciccarelli, P., Donati Sarti, C., Balsotti, G., Pupita, P., and Parazzini, F.

19. Risk factors for genital prolapse in non-hysterectomized women around menopause - Results from a large cross-sectional study in menopausal clinics in Italy

Author

Aloysio, D., Di Donato, P., Giulini, Na, Modena, B., Cicchetti, G., Comitini, G., Gentile, G., Cristiani, P., Careccia, A., Esposito, E., Gigli, C., Mandruzzato, G., Petraglia, F., Bertelli, F., Del Frate, G., Garofalo, S., Marino, L., Costa, MR, Quaranta, S., Bossi, Cm, Amantea, P., Omodei, U., Vaccari, M., Luerti, M., Repetti, F., Zandonini, G., Raspagliesi, F., Dolci, F., Zacchi, V., Bennici, S., Polizzotti, G., Bottino, S., Raffaelli, F., Minervini, C., Colombo, D., Belloni, C., Viani, A., Cecchini, G., Winkler, S., Samaja, Ba, Pasinetti, E., Penotti, M., Malanetto, C., Massobrio, M., Campagnoli, C., Dolfin, G., Tartaglino, P., Mossotto, D., Pesando, P., Pacilli, L., Rattazzi, Pd, Arisi, E., Gamper, M., Salvatores, D., Bocchin, E., Stellin, G., Meli, G., Azzini, V., Tirozzi, F., Buoso, G., Fraioli, R., Marsoni, V., Cetera, C., Sposetti, R., Bellati, U., Angeloni, C., Buonerba, M., Garzarelli, S., Santilli, C., Mucci, M., Di Nisio, Q., Falasca, L., Ferrante, D., Cirese, E., Todaro, Pa, Romanini, C., Spagnuolo, L., Lanzone, A., Donadio, C., Fabiani, M., Baldaccini, E., Votano, S., Serra, Gb, Bellardini, P., Massacesi, L., Donini, G., Genazzani, Ra, Scarselli, G., Curiel, P., Leo, V., Melani, A., D Ancona, Vl, Giarre, G., Di Gioia, E., Ciccarelli, P., Sarti, Cd, Balsotti, G., Pupita, P., Mincigrucci, M., Spadafora, A., Santeufemia, G., D Andrea, A., Chiantera, A., Montemagno, U., Staiano, S., Arienzo, R., Pastore, Ar, Tamburrino, A., Colacurci, A., Izzo, S., Zumpano, N., Pascarella, A., Silvio, Mg, Di Prisco, L., Lauda, N., Sorrentino, O., Agrimi, C., Casarella, G., Pisaturo, G., Senatore, G., Ruccia, G., Fasolino, A., Tropea, P., Stigliano, Cm, Giannice, C., Vadala, P., Coco, A., Lombardo, R., Barese, G., Masciari, G., Pirillo, P., Gioffre, T., Ferruccio, C., Agostinelli, D., Tonti, Gc, Scopelliti, A., Schonauer, S., Bongiovanni, F., Tinelli, F., Poddi, Er, Scarpello, F., Colonna, L., Fischetti, G., Doria, R., Trombetta, G., Cocca, Eb, Carone, D., Nocera, F., Giambanco, V., Giannola, C., Graziano, R., Mezatesta, M., Vegna, G., Giannone, G., Palumbo, G., Cancellieri, F., Mondo, A., Cordopatri, A., Carrubba, M., Mazzola, V., Ettore, G., D Asta, S., Di Liberto, P., Massacesi, A., Aloysio, P., Ognissanti, F., Gambacciani, A., Graziottin, A., Baldi, C., Parazzini, F., Chatenoud, L., and Francesca Chiaffarino

22. La violazione della vendita di beni al consumatore per difetto di conformità: i presupposti della c.d. responsabilità del venditore e la distribuzione degli oneri probatori

Author

piraino, De Cristofaro, G, Afferni, G, Azzarri, F, Bertelli, F, Cherti, S, D’Acunto, L, dalla Massara, T, Faccioli, M, Fadda, R, Girolami, M, Maniaci, A, Oliviero, F, Perfetti, G, Piraino, F, Salvi, G, Venturelli, A, and piraino

Subjects
obligation, Consumer contract, consumer sale of good, Settore IUS/01 - Diritto Privato, so-called "liability of the seller", remedies ofr lack of conformity, guarantee, lack of conformity, burden of proof
Abstract

Il capitolo affronta la nuova disciplina della vendita di beni materiali di consumo, introdotta in recepimento della dir. 2019/771. Lo studio approfondisce il tema della violazione del contratto a causa del difetto di conformità del bene, inquadrando la disciplina riformata nel quadro del dibattito sulla natura giuridica del vincolo del venditore di beni di consumo. Dallo studio emerge confermata la qualificazione di tale vincolo come garanzia. Sulla base di tale inquadramento è possibile meglio cogliere i miglioramenti apportati dalla nuova disciplina, ma soprattutto le inadeguatezze, imputabili in larga misura a scelte errate in sede di attuazione della direttiva. The chapter deals with the new law rules about the consumer sale of material goods, introduced in transposition of the dir. 2019/771. The study examines the issue of breach of contract due to the lack of conformity of the goods, framing the reformed discipline in the context of the debate on the juridical nature of the bond of the seller of consumer goods. The study confirms the qualification of this bond as a guarantee. On the basis of this framework it is possible to better grasp the improvements brought about by the new discipline, but above all the inadequacies, largely attributable to incorrect choices in the transposition of the directive.

Published
2022

23. Ducatus Oswieczimen et Zatoriensis descriptio

Author

Porebski, Stanislaw and Bertelli, Ferrando

Subjects
Oświęcim, Poland
Abstract

"The Oldest Regional Map of Southwestern Poland Rare early map of Southwestern Poland, drawn by Stanislaw Porebski and published in Venice. The map is focused on the border between the historical regions of Silesia and Lesser Poland. Centered on the Duchy of Oswiecim and the Duchy of Zator, the map includes the source of the Vistula River, which crosses the map from the southwest to the northeast, extending nearly to Krakow. The mapmaker's name, Stanislaw Porebski (1539-1581), is shown at the bottom left. Porebski studied in Padua from 1559 to 1562. Upon his return, he made an indepth study of the region which led to the publication of this map in Venice, with a dedication to Zignìmunt Myskowski, who was the chief administrator of the Oświęcim and Zator region beginning in 1563. While Almagia opined that an earlier example (1561) might exist, no example is known and the dedication suggests that the first state is 1563. The map would later be copied by Ortelius in 1573. States of the Map There are 2 states: Dated 1563 Dated 1565" The map depicts the regions of Oswiecim and Zator, in the Lesser Poland Voivodeship, located on the north banks of the Vistula and upstream from Krakow. The author of the map is Stanislaw Poreski (c. 1559 - 1581) Polish, a descendant of landowners and public officials in the area, who studied in Padua from 1559 to 1562. On his return to Poland he undertook an in-depth study of his region of origin the results of which led to the publication, in Venice, by the typography of Ferrando Bertelli, of the map in question. The map is dedicated to Zignimunt Myskowski, the chief administrator of the Oswiecim and Zator region since 1563. According to Almagia, who notes how the last digit of the date is obviously corrected, the original date of the map could be 1561 but we find no confirmation. The plate had a second printing, unchanged, just two years later, and formed the model for the map of the region that Ortelius published in his Theatrum Orbis Terrarum. (Ruderman, 2022), Bifolco #509

Published
1563

24. Bacchanalian Scene

Author

Bertelli, Francesco and The Cleveland Museum of Art

Subjects
European, Southern European, Italian
Published
1500

25. Mask side-effects are related to gender in long-term CPAP: results from the InterfaceVent real-life study.

Author

Vidal C, Bertelli F, Mallet JP, Gilson R, Borel JC, Gagnadoux F, Bourdin A, Molinari N, and Jaffuel D

Subjects
Adult, Aged, Female, Humans, Male, Middle Aged, Cohort Studies, Cross-Sectional Studies, Patient Compliance, Prospective Studies, Sex Characteristics, Sex Factors, Sleep Apnea, Obstructive therapy, Sleep Apnea, Obstructive epidemiology, Sleep Apnea, Obstructive diagnosis, Sleep Apnea, Obstructive physiopathology, Time Factors, Continuous Positive Airway Pressure adverse effects, Masks adverse effects
Abstract

Background: Over the past three decades, our understanding of sleep apnea in women has advanced, revealing disparities in pathophysiology, diagnosis, and treatment compared to men. However, no real-life study to date has explored the relationship between mask-related side effects (MRSEs) and gender in the context of long-term CPAP., Methods: The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks, no gender specific mask series). MRSE were assessed by the patient using visual analog scales (VAS). CPAP-non-adherence was defined as a mean CPAP-usage of less than 4 h per day. The primary objective of this ancillary study was to investigate the impact of gender on the prevalence of MRSEs reported by the patient. Secondary analyses assessed the impact of MRSEs on CPAP-usage and CPAP-non-adherence depending on the gender., Results: A total of 1484 patients treated for a median duration of 4.4 years (IQ 25-75 : 2.0-9.7) were included in the cohort, with women accounting for 27.8%. The prevalence of patient-reported mask injury, defined as a VAS score ≥ 5 (p = 0.021), was higher in women than in men (9.6% versus 5.3%). For nasal pillow masks, the median MRSE VAS score for dry mouth was higher in women (p = 0.039). For oronasal masks, the median MRSE VAS score for runny nose was higher in men (p = 0.039). Multivariable regression analyses revealed that, for both women and men, dry mouth was independently and negatively associated with CPAP-usage, and positively associated with CPAP-non-adherence., Conclusion: In real-life patients treated with long-term CPAP, there are gender differences in patient reported MRSEs. In the context of personalized medicine, these results suggest that the design of future masks should consider these gender differences if masks specifically for women are developed. However, only dry mouth, a side effect not related to mask design, impacts CPAP-usage and non-adherence., Trial Registration: INTERFACEVENT IS REGISTERED WITH CLINICALTRIALS.GOV (NCT03013283).FIRST REGISTRATION DATE IS 2016-12-23., (© 2024. The Author(s).)

Published
2024
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26. Enhancing parental understanding of congenital heart disease through personalized prenatal counseling with 3D printed hearts.

Author

Galliotto F, Veronese P, Cerutti A, Zemin F, Bertelli F, Di Salvo G, Guariento A, and Vida VL

Subjects
Humans, Female, Pregnancy, Adult, Pilot Projects, Fetal Heart diagnostic imaging, Heart Defects, Congenital diagnostic imaging, Printing, Three-Dimensional, Parents psychology, Counseling methods, Ultrasonography, Prenatal methods
Abstract

Objectives: In addition to a correct prenatal diagnosis of congenital heart disease (CHD), comprehensive parental counseling is crucial to ensure that parents are well-informed about the condition of the fetus. This study aims to investigate whether there is a significant difference in the information acquired by parents through traditional counseling, utilizing 2-dimensional (2D) illustrations and images, compared to an advanced approach utilizing personalized three-dimensional (3D) printed models of the fetal heart developed from 3D ultrasound imaging., Methods: This study, designed as a pilot randomized control trial, enrolled pregnant women with gestational ages greater than 18 weeks, whose fetuses were diagnosed with CHD and referred to our center between November, 2020 and June, 2021. Two groups of patients were included in the study. The first group received standard medical counseling with 2D images and illustrations, while the second group underwent advanced counseling with 3D-printed patient-specific heart models. Both groups were then required to complete the same survey in which the knowledge of the CHD was investigated. The 3D models were created from 3D ultrasound imaging and printed using resin materials in both 1:1 and 5:1 scale., Results: A comparison of the scores obtained from the two groups revealed that 3D visualization of the fetus's heart has the potential to increase parental knowledge about CHD and the required surgical procedures. Furthermore, all couples expressed interest in receiving a 1:1 scale model of their baby's heart., Conclusion: Personalized prenatal counseling with 3D-ultrasound-based heart models positively impacts parents' understanding of CHD. The use of 3D models provides a more comprehensive and accessible representation of the condition, contributing to an increased knowledge gain, and potentially helping to support informed decisions regarding their child's care., (© 2024 John Wiley & Sons Ltd.)

Published
2024
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27. Successful Implantation of HeartMate3 in a Small Child After Multimodality Imaging Pathway to Assess Feasibility.

Author

Italiano EG, Bertelli F, Cao I, Motta R, Di Salvo G, Vida V, and Padalino MA

Subjects
Humans, Female, Child, Multimodal Imaging methods, Imaging, Three-Dimensional methods, Tomography, X-Ray Computed methods, Feasibility Studies, Heart-Assist Devices
Abstract

The current use of intracorporeal left ventricular assist devices in children is still limited by small body dimensions. Many children weighing of less than 30 kg requiring durable mechanical circulatory support are implanted with the Berlin Heart EXCOR, a paracorporeal device. We present the case of a girl aged 10 years with a body surface area of 1.01 m 2 undergoing a safe and effective HeartMate3 implantation despite extremely small thoracic dimensions. Using computed tomography-derived three-dimensional (3D) reconstruction, it was possible to simulate several device positions finding the best HeartMate3 lodging. Simulation-guided pump placement was then obtained in the operating room. Normal HeartMate3 functioning was registered until heart transplant. Our experience shows that preoperative planning and virtual fitting simulation can be effective to assess safety of HeartMate3 implantation even in small children. The 3D reconstruction and simulation may help to increase the pool of children candidates for this device, even though a larger experience is needed to assess the risk profile of the HeartMate3 in such small patients., Competing Interests: Disclosure: The authors have no conflicts of interest to report., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASAIO.)

Published
2024
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28. ADCT-602, a Novel PBD Dimer-containing Antibody-Drug Conjugate for Treating CD22-positive Hematologic Malignancies.

Author

Zammarchi F, Havenith KE, Sachini N, Janghra N, Chivers S, Idusogie E, Gaudio E, Tarantelli C, Bertelli F, Santos K, Tyrer P, Corbett S, Spriano F, Golino G, Cascione L, Bertoni F, Hartley JA, and van Berkel PH

Subjects
Humans, Rats, Animals, Macaca fascicularis, Sialic Acid Binding Ig-like Lectin 2, Immunoconjugates pharmacology, Immunoconjugates therapeutic use, Antineoplastic Agents therapeutic use, Lymphoma, B-Cell drug therapy, Hematologic Neoplasms drug therapy
Abstract

Relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and lymphomas have poor patient outcomes; novel therapies are needed. CD22 is an attractive target for antibody-drug conjugates (ADCs), being highly expressed in R/R B-ALL with rapid internalization kinetics. ADCT-602 is a novel CD22-targeting ADC, consisting of humanized mAb hLL2-C220, site specifically conjugated to the pyrrolobenzodiazepine dimer-based payload tesirine. In preclinical studies, ADCT-602 demonstrated potent, specific cytotoxicity in CD22-positive lymphomas and leukemias. ADCT-602 was specifically bound, internalized, and trafficked to lysosomes in CD22-positive tumor cells; after cytotoxin release, DNA interstrand crosslink formation persisted for 48 hours. In the presence of CD22-positive tumor cells, ADCT-602 caused bystander killing of CD22-negative tumor cells. A single ADCT-602 dose led to potent, dose-dependent, in vivo antitumor activity in subcutaneous and disseminated human lymphoma/leukemia models. Pharmacokinetic analyses (rat and cynomolgus monkey) showed excellent stability and tolerability of ADCT-602. Cynomolgus monkey B cells were efficiently depleted from circulation after one dose. Gene signature association analysis revealed IRAK1 as a potential marker for ADCT-602 resistance. Combining ADCT-602 + pacritinib was beneficial in ADCT-602-resistant cells. Chidamide increased CD22 expression on B-cell tumor surfaces, increasing ADCT-602 activity. These data support clinical testing of ADCT-602 in R/R B-ALL (NCT03698552) and CD22-positive hematologic cancers., (©2024 The Authors; Published by the American Association for Cancer Research.)

Published
2024
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29. Intracorporeal LVAD implantation in pediatric patients: A single-center 10 years' experience.

Author

Cao I, Italiano EG, Bertelli F, Motta R, Castaldi B, Pergola V, Guariento A, Scattolin F, Di Salvo G, Vida V, and Padalino MA

Subjects
Adolescent, Humans, Child, Prosthesis Implantation adverse effects, Postoperative Complications, Retrospective Studies, Treatment Outcome, Heart Failure surgery, Heart Transplantation, Heart-Assist Devices adverse effects
Abstract

Background: Mechanical cardiac support is currently an effective strategy to reduce morbidity and mortality in pediatric patients. However, solid evidence regarding the feasibility of intracorporeal devices in children still needs to be provided. We report our 10-year experience with intracorporeal left ventricular assist devices (LVAD) in children., Materials and Methods: We included all patients undergoing intracorporeal, continuous-flow LVAD implantation between 2012 and 2022. Baseline and postoperative data were collected from the institutional database., Results: Seven HeartWare and 4 HeartMate3 were implanted in 11 patients (median age 13.9 years, median body surface area - BSA - 1.42 m 2 , IQR 1.06-1.68). The most frequent indication to LVAD implant was dilated cardiomyopathy (72.7%). All candidates underwent a thorough preoperative advanced imaging. Three-dimensional reconstructions and implant fit simulation were performed when BSA was <1.2 m 2 , weight <30 kg, or internal transverse thoracic diameter <20 cm. There was no operative death. The most common postoperative complication was surgical re-exploration due to bleeding (27.3%). One patient died of severe neurological complications after about 3 months of hospitalization. No late deaths or unplanned re-hospitalizations occurred in the remaining 10, 6 of whom were discharged home. There were no major complications at the follow-up. All survivors underwent successful heart transplantation., Conclusions: Intracorporeal LVAD implantation proved to be a potentially feasible and safe option in young teenagers and children whose BSA was >1.0 m 2 . In borderline cases, the 3D reconstruction with implant fit simulation can effectively help to identify those patients who can safely undergo intrathoracic LVAD implantation., (© 2024 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Published
2024
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30. The introduction of surgical simulation on three-dimensional-printed models in the cardiac surgery curriculum: an experimental project.

Author

Cattapan C, Guariento A, Bertelli F, Galliotto F, Vazzoler C, Magagna P, Gerosa G, and Vida V

Subjects
Humans, Pilot Projects, Curriculum, Clinical Competence, Cardiac Surgical Procedures, Internship and Residency, Heart Defects, Congenital diagnostic imaging, Heart Defects, Congenital surgery
Abstract

Aims: Training in congenital cardiac surgery has become more and more difficult because of the reduced opportunities for trainees in the operating room and the high patient anatomical variability. The aim of this study was to perform a pilot evaluation of surgical simulation on a simple 3D-printed heart model in training of young surgeons and its potential inclusion in the curriculum of residency programs., Methods: A group of 11 residents performed a surgical correction of aortic coarctation using a 3D-printed surgical model. After teaching the surgical procedure, a simulation was performed twice, at different times, and was evaluated quantitatively and qualitatively by a senior surgeon. A 3D model-based training program was then developed and incorporated into our cardiac surgery training program., Results: A significant improvement in surgical technique was observed between the first and second surgical simulations: median of 65% [interquartile range (IQR) = 61-70%] vs. 83% (IQR = 82-91%, P < 0.001). The median time required to run the simulation was significantly shorter during the second simulation: 39 min (IQR = 33-40) vs. 45 min (IQR = 37-48; P = 0.02). Regarding the simulation program, a basic and an advanced program were developed, including a total of 40 different simulated procedures divided into 12 sessions., Conclusion: Surgical simulation using 3D-printing technology can be an extremely valuable tool to improve surgical training in congenital heart disease. Our pilot study can represent the first step towards the creation of an integrated training system on 3D-printed models of congenital and acquired heart diseases in other Italian residency programs., (Copyright © 2023 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Published
2024
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31. 3D Reconstruction for a Complex Pediatric Redo Aortic Arch Surgery in a 9-Year-Old Ukrainian Refugee.

Author

Garufi L, Guariento A, Bertelli F, and Vida V

Subjects
Humans, Child, Refugees statistics & numerical data, Reoperation, Male, Heart Defects, Congenital surgery, Ukraine, Imaging, Three-Dimensional methods, Aorta, Thoracic surgery, Aorta, Thoracic diagnostic imaging, Printing, Three-Dimensional
Abstract

Redo aortic surgery poses significant challenges, particularly in complex scenarios involving congenital heart conditions that have been previously operated on several years prior. The integration of three-dimensional (3D) reconstruction and printing holds immense potential to greatly improve surgical precision, particularly in critical situations.

Published
2023
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33. Fast-track virtual reality software to facilitate 3-dimensional reconstruction in congenital heart disease.

Author

Bertelli F, Raimondi F, Godard C, Bergonzoni E, Cattapan C, Gastino E, Galliotto F, Boddaert N, El Beheiry M, Masson JB, Guariento A, and Vida VL

Abstract

Objectives: Two limitations of the clinical use of 3-dimensional (3D) reconstruction and virtual reality systems are the relatively high cost and the amount of experience required to use hardware and software to effectively explore medical images. We have tried to simplify the process and validate a new tool developed for this purpose with a novel software package., Methods: Five patients with right partial anomalous pulmonary venous return with adequate preoperative images acquired with magnetic resonance imaging were enrolled. Five volunteers with no previous experience in the field of 3D reconstruction were instructed to use the software after viewing a short video tutorial. Users were then asked to create a 3D model of each patient's heart using DIVA software. Their results were compared quantitatively and qualitatively with a benchmark reconstruction performed by an experienced user., Results: All our participants recreated 3D models in a relatively short time, maintaining a good overall quality (average quality score ≥ 3 on a scale of 1-5). The overall trend of all the parameters analysed showed a statistical improvement between case 1 and case 5, as users became more and more experienced., Conclusions: DIVA is a simple software program that allows accurate 3D reconstruction in a relatively short time ("fast-track" virtual reality). In this study, we demonstrated the potential use of DIVA by inexperienced users, with a significant improvement in quality and time after a few cases were performed. Further studies are needed to confirm the potential application of this technology on a larger scale., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Published
2023
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34. Three-Dimensional-Enabled Surgical Planning for the Correction of Right Partial Anomalous Pulmonary Venous Return.

Author

Cattapan C, Guariento A, Bifulco O, Caraffa R, Bertelli F, Reffo E, Padalino M, Di Salvo G, and Vida V

Abstract

Objectives: The surgical technique for right partial anomalous pulmonary venous return (PAPVR) depends on the location of the anomalous pulmonary veins (PVs). With this in mind, we sought to evaluate the impact of 3D heart segmentation and reconstruction on preoperative surgical planning. Methods: A retrospective study was conducted on all patients who underwent PAPVR repair at our institution between January 2018 and October 2021; three-dimensional segmentations and reconstructions of all the heart anatomies were performed. A score (the PAPVR score) was established and calculated using two anatomical parameters (the distance between the most cranial anomalous PV and the superior rim of the sinus venosus defect/the sum of the latter and the distance between the PV and the azygos vein) to predict the type of correction. Results: A total of 30 patients were included in the study. The PAPVR score was found to be a good predictor of the type of surgery performed. A value > 0.68 was significantly associated with a Warden procedure (p < 0.001) versus single/double patch repair. Conclusions: Three-dimensional heart segmentations and reconstructions improve the quality of surgical planning in the case of PAPVR and allow for the introduction of a score that may facilitate surgical decisions on the type of repair required.

Published
2023
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35. Rescue ross procedure and mitral valve repair on a low birth weight preterm neonate.

Author

Garufi L, di Candia A, Bertelli F, Guariento A, and Vida VL

Subjects
Aortic Valve abnormalities, Aortic Valve surgery, Child, Follow-Up Studies, Humans, Infant, Low Birth Weight, Infant, Newborn, Mitral Valve surgery, Retrospective Studies, Treatment Outcome, Aortic Valve Insufficiency congenital, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation methods, Pulmonary Valve surgery
Abstract

Although mid- and long-term outcomes after the Ross procedure for aortic valve disease have been increasingly improving over the years, this is still a rather challenging operation in neonates and small children. This is particularly true for patients with associated congenital heart defects and critical clinical conditions. Herein we describe the application of this procedure as a rescue operation in emergency circumstances in a low-birth-weight neonate with severe aortic stenosis, aortic regurgitation and mitral regurgitation after a previous aortic coartectomy., (© 2022 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC.)

Published
2022
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36. Preclinical Development of ADCT-601, a Novel Pyrrolobenzodiazepine Dimer-based Antibody-drug Conjugate Targeting AXL-expressing Cancers.

Author

Zammarchi F, Havenith KE, Chivers S, Hogg P, Bertelli F, Tyrer P, Janghra N, Reinert HW, Hartley JA, and van Berkel PH

Subjects
Animals, Benzodiazepines pharmacology, Cell Line, Tumor, Humans, Mice, Pyrroles, Xenograft Model Antitumor Assays, Antineoplastic Agents pharmacology, Antineoplastic Agents therapeutic use, Immunoconjugates pharmacology, Immunoconjugates therapeutic use, Neoplasms drug therapy, Neoplasms genetics
Abstract

AXL, a tyrosine kinase receptor that is overexpressed in many solid and hematologic malignancies, facilitates cancer progression and is associated with poor clinical outcomes. Importantly, drug-induced expression of AXL results in resistance to conventional chemotherapy and targeted therapies. Together with its presence on multiple cell types in the tumor immune microenvironment, these features make it an attractive therapeutic target for AXL-expressing malignancies. ADCT-601 (mipasetamab uzoptirine) is an AXL-targeted antibody-drug conjugate (ADC) comprising a humanized anti-AXL antibody site specifically conjugated using GlycoConnect technology to PL1601, which contains HydraSpace, a Val-Ala cleavable linker and the potent pyrrolobenzodiazepine (PBD) dimer cytotoxin SG3199. This study aimed to validate the ADCT-601 mode of action and evaluate its efficacy in vitro and in vivo, as well as its tolerability and pharmacokinetics. ADCT-601 bound to both soluble and membranous AXL, and was rapidly internalized by AXL-expressing tumor cells, allowing release of PBD dimer, DNA interstrand cross-linking, and subsequent cell killing. In vivo, ADCT-601 had potent and durable antitumor activity in a wide variety of human cancer xenograft mouse models, including patient-derived xenograft models with heterogeneous AXL expression where ADCT-601 antitumor activity was markedly superior to an auristatin-based comparator ADC. Notably, ADCT-601 had antitumor activity in a monomethyl auristatin E-resistant lung-cancer model and synergized with the PARP inhibitor olaparib in a BRCA1-mutated ovarian cancer model. ADCT-601 was well tolerated at doses of up to 6 mg/kg and showed excellent stability in vivo. These preclinical results warrant further evaluation of ADCT-601 in the clinic., (©2022 The Authors; Published by the American Association for Cancer Research.)

Published
2022
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37. Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea.

Author

Bertelli F, Suehs CM, Mallet JP, Court-Fortune I, Gagnadoux F, Borel JC, Gaubert O, Molinari N, Bourdin A, and Jaffuel D

Subjects
Aged, Comorbidity, Cross-Sectional Studies, Female, France epidemiology, Humans, Incidence, Male, Middle Aged, Polysomnography, Retrospective Studies, Sleep Apnea Syndromes epidemiology, Treatment Outcome, COVID-19 epidemiology, Continuous Positive Airway Pressure methods, Pandemics, Sleep Apnea Syndromes therapy, Treatment Adherence and Compliance
Abstract

Background: Whether the COVID-19 pandemic impacts Positive Airway Pressure (PAP) adherence over the long-term is unknown and only preliminary short-term data have been reported., Methods: With the aim of describing the impact of the first and second waves of COVID-19 on PAP adherence during 2020 in France, we designed a cross-sectional study of Sleep-Apnea (SA)-patients under PAP telemonitoring. To examine PAP adherence in adult SA patients, we assessed de-identified data from a non-profit healthcare provider database during the period January 1, 2019 to December 31, 2020. Included patients met the following criteria: (i) PAP-treated for at least 4 months before January 1, 2019 and with continuous PAP during both 2019 and 2020; (ii) ≥ 360 daily PAP telemonitored data per year. For PAP adherence, data were collected using the PAP-software., Results: 8477/10482 patients were finally included in the analysis [72.4% male, median age 70 years (IQ 25-75 : 61-77], 25.6% < 62 years old, initial Apnea-Hypopnea Index (AHI) of 41 (31-59)/h. Median PAP adherence was 7.21 (6.12-8.10) h/day in 2020 versus 7.12 (6.05-8.02) h/day in 2019, p < 0.001. The median difference in PAP adherence between the first 2020 lockdown and the corresponding 2019 weeks was 9.75 (CI 95% 8.75-10.75) min/day, p < 0.001. The median difference in PAP adherence between the second 2020 lockdown and the corresponding 2019 weeks was 5.00 (CI 95% 4.00-6.00) min/day, p < 0.001. If we consider the minimal clinically important difference of 30 min for PAP adherence, 30.4% and 26% of the patients increased their PAP adherence by at least 30 min during the first and second lockdowns respectively; 17.6% and 19.3% of the patients lowered their PAP adherence by at least 30 min in the first and second lockdowns, respectively., Conclusion: During the first and second lockdowns, the COVID-19 pandemic had a clinically irrelevant effect on PAP adherence for the study population. Future studies are needed to describe COVID-19 pandemic impact on PAP adherence not only for long-term PAP-treated SA patients but also for incident cases. Trial registration The COVADENE study was registered on March 1st, 2021 on ClinicalTrials.gov (Identifier: NCT04775966)., (© 2022. The Author(s).)

Published
2022
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38. Three-dimensional Printing for Hybrid Closure of Complex Muscular Ventricular Septal Defects.

Author

Longinotti L, Castaldi B, Bertelli F, Vida VL, and Padalino MA

Subjects
Cardiac Catheterization methods, Echocardiography methods, Heart Septal Defects, Ventricular diagnosis, Heart Ventricles diagnostic imaging, Humans, Infant, Newborn, Radiography, Thoracic, Cardiac Surgical Procedures methods, Heart Septal Defects, Ventricular surgery, Heart Ventricles surgery, Printing, Three-Dimensional
Abstract

The identification and surgical closure of apical complex muscular ventricular septal defects remains a difficult problem because of their location in the ventricular septum distal to the moderating band. Three-dimensional reconstruction can help the surgeon to better understand the location and structure of congenital cardiac defects. We report the case of a child with multiple apical complex muscular ventricular septal defects closed through a hybrid approach with the aid of a 3-dimensional printed model., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Published
2022
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39. Fast-track virtual reality for cardiac imaging in congenital heart disease.

Author

Raimondi F, Vida V, Godard C, Bertelli F, Reffo E, Boddaert N, El Beheiry M, and Masson JB

Subjects
Child, Humans, Imaging, Three-Dimensional, Magnetic Resonance Imaging, Printing, Three-Dimensional, Heart Defects, Congenital diagnostic imaging, Virtual Reality
Abstract

Background and Aim of the Study: We sought to evaluate the appropriateness of cardiac anatomy renderings by a new virtual reality (VR) technology, entitled DIVA, directly applicable to raw magnetic resonance imaging (MRI) data without intermediate segmentation steps in comparison to standard three-dimensional (3D) rendering techniques (3D PDF and 3D printing). Differences in post-processing times were also evaluated., Methods: We reconstructed 3D (STL, 3D-PDF, and 3D printed ones) and VR models of three patients with different types of complex congenital heart disease (CHD). We then asked a senior pediatric heart surgeon to compare and grade the results obtained., Results: All anatomical structures were well visualized in both VR and 3D PDF/printed models. Ventricular-arterial connections and their relationship with the great vessels were better visualized with the VR model (Case 2); aortic arch anatomy and details were also better visualized by the VR model (Case 3). The median post-processing time to get VR models using DIVA was 5 min in comparison to 8 h (range 8-12 h including printing time) for 3D models (PDF/printed)., Conclusions: VR directly applied to non-segmented 3D-MRI data set is a promising technique for 3D advanced modeling in CHD. It is systematically more consistent and faster when compared to standard 3D-modeling techniques., (© 2021 Wiley Periodicals LLC.)

Published
2021
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41. Apnoea-hypopnoea indices determined via continuous positive airway pressure (AHI-CPAP flow ) versus those determined by polysomnography (AHI-PSG gold ): a protocol for a systematic review and meta-analysis.

Author

Bertelli F, Suehs CM, Mallet JP, Rotty MC, Pepin JL, Gagnadoux F, Matzner-Lober E, Bourdin A, Molinari N, and Jaffuel D

Subjects
Adolescent, Adult, Body Mass Index, Continuous Positive Airway Pressure, Humans, Meta-Analysis as Topic, Polysomnography, Systematic Reviews as Topic, Sleep Apnea, Obstructive diagnosis, Sleep Apnea, Obstructive therapy, Telemedicine
Abstract

Introduction: To date, continuous positive airway pressure (CPAP) remains the cornerstone of obstructive sleep apnoea treatment. CPAP data describing residual sleep-disordered breathing events (ie, the CPAP-measured apnoea-hypopnoea indices (AHI-CPAP flow )) is difficult to interpret because it is an entirely different metric than the polysomnography (PSG) measured AHI gold standard (AHI-PSG gold ). Moreover, manufacturer definitions for apnoea and hypopnoea are not only different from those recommended for PSG scoring, but also different between manufacturers. In the context of CPAP initiation and widespread telemedicine at home to facilitate sleep apnoea care, there is a need for concrete evidence that AHI-CPAP flow can be used as a surrogate for AHI-PSG gold ., Methods and Analysis: No published systematic review and meta-analysis (SRMA) has compared the accuracy of AHI-CPAP flow against AHI-PSG gold and the primary objective of this study is therefore to do so using published data. The secondary objectives are to similarly evaluate other sleep disordered breathing indices and to perform subgroup analyses focusing on the inclusion/exclusion of central apnoea patients, body mass index levels, CPAP device brands, pressure titration modes, use of a predetermined and fixed pressure level or not, and the impact of a 4% PSG desaturation criteria versus 3% PSG on accuracy. The Preferred Reporting Items for SRMA protocols statement guided study design. Randomised controlled trials and observational studies of adult patients (≥18 years old) treated by a CPAP device will be included. The CPAP intervention and PSG comparator must be performed synchronously. PSGs must be scored manually and follow the American Academy of Sleep Medicine guidelines (2007 AASM criteria or more recent). To assess the risk of bias in each study, the Quality Assessment of Diagnostic Accuracy Studies 2 tool will be used., Ethics and Dissemination: This protocol received ethics committee approval on 16 July 2020 (IRB&#95;MTP&#95;2020&#95;07&#95;2020000404) and results will be disseminated via peer-reviewed publications., Prospero/trial Registration Numbers: CRD42020159914/NCT04526366; Pre-results., Competing Interests: Competing interests: AB reports grants, personal fees, non-financial support and other from AstraZeneca, grants, personal fees and other from GSK, grants, personal fees, non-financial support and other from Boeringher Ingelheim, personal fees, non-financial support and other from Novartis, personal fees and other from Teva, personal fees and other from Regeneron, personal fees, non-financial support and other from Chiesi Pharmaceuticals, personal fees, non-financial support and other from Actelion, other from Gilead, and personal fees and non-financial support from Roche, outside the submitted work. FG reports grants and personal fees from ResMed, personal fees and non-financial support from Sefam, personal fees from Cidelec, personal fees and non-financial support from Novartis, personal fees and non-financial support from Nyxoah, non-financial support from Boehringer Ingelheim, grants and personal fees from Philips Respironics, and non-financial support from Asten, outside the submitted work. DJ reports personal fees from Philips Healthcare, from ResMed, personal fees and non-financial support from Sefam, personal fees from Lowenstein, personal fees from GSK, from Boehringher Ingelheim, grants and personal fees from Novartis, personal fees and non-financial support from AstraZeneca, personal fees from Chiesi Pharmaceuticals and personal fees from Sanofi, outside the submitted work. JLP reports grants and other from Air Liquide Foundation, grants, personal fees and other from AGIR a dom, grants, personal fees and other from AstraZeneca, grants and other from Fisher & Paykel, grants and other from Mutualia, grants, personal fees and other from Philips, grants, personal fees and other from ResMed, grants and other from VitalAire, personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Jazz Pharmaceuticals, personal fees from NightBalance and personal fees from Sefam, outside the submitted work. NM and CMS report grants from AstraZeneca, outside the submitted work., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2021
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42. Three-Dimensional Printing of Fetal Heart With d-Transposition of the Great Arteries From Ultrasound Imaging Data.

Author

Veronese P, Bertelli F, Cattapan C, Andolfatto M, Gervasi MT, and Vida VL

Subjects
Female, Humans, Imaging, Three-Dimensional, Pregnancy, Tomography, X-Ray Computed methods, Fetal Heart diagnostic imaging, Printing, Three-Dimensional, Transposition of Great Vessels diagnosis, Ultrasonography, Prenatal methods
Abstract

We reconstructed and printed a 3D model of the fetal heart affected by d-transposition of the great arteries from prenatal ultrasound images. Our 3D model revealed to be very helpful in showing the basic anatomical features of fetal complex Congenital Heart Disease (CHD) and represents an interesting additional diagnostic tool to the current standard imaging armamentarium, improving the quality of prenatal parental counseling.

Published
2021
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43. Temperature-Induced Chemical Changes in Lubricant Automotive Oils Evaluated Using Raman Spectroscopy.

Author

de M Bezerra AC, de A Coelho NM, Bertelli F, Pacheco MTT, and Silveira L Jr

Abstract

Automotive engine lubricating oils are not only intended to reduce friction between parts, but also act on the cooling of motor components and protection of metals against corrosion. To improve its properties and efficiency, additives are added to the base oil for different goals. However, over time of use, external factors modify its properties, such as the engine operating temperature, the frictional force between parts, the mixture of this oil with fuel before burning and with combustion products, causing loss of their efficiency. This work aimed to evaluate, with Raman spectroscopy technique, the temperature-induced changes related to degradation of mineral, semi-synthetic and synthetic automotive lubricating oils. Samples being subject to periodic heating cycle were kept to average temperature of 133 ℃, considering 8 h per day, for six days, until complete 48 h of heating. By analyzing the Raman spectra, it was possible to identify common peaks between the three types of oils and changes caused by heating cycles. Principal components analysis showed that the synthetic oil degraded in less extent than the semi-synthetic one, and this one degraded less than the mineral oil. Spectral models to predict the heating time based on the spectral variations identified using principal components analysis and the regression done using partial least squares, using the heating time as independent variable and the spectral features as dependent variables, was able to predict the heating time for each of oil types with high correlation and prediction error ( r  > 0.97 and error <4.0 h) for both principal components analysis and partial least squares regression models. Raman technique was able to identify chemical changes resulting from the heating of lubricant oils and to correlate these changes with the heating time, thus becoming a technique of interest for the preventive maintenance area.

Published
2021
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44. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study.

Author

Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, and Jaffuel D

Subjects
Aged, Continuous Positive Airway Pressure instrumentation, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Prospective Studies, Sleep Apnea, Obstructive physiopathology, Continuous Positive Airway Pressure adverse effects, Continuous Positive Airway Pressure trends, Sleep Apnea, Obstructive therapy, Sleepiness
Abstract

Background: For some patients, Continuous Positive Airway Pressure (CPAP) remains an uncomfortable therapy despite the constant development of technological innovations. To date, no real life study has investigated the relationship between mask related side-effects (MRSEs) and CPAP-non-adherence (defined as < 4 h/day) or residual-excessive-sleepiness (RES, Epworth-Sleepiness-Scale (ESS) score ≥ 11) in the long-term., Methods: The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks). MRSEs were evaluated using visual-analogue-scales, CPAP-data using CPAP-software, sleepiness using ESS., Results: 1484 patients were included in the analysis (72.2% male, median age 67 years (IQ 25-75 : 60-74), initial Apnea-Hypopnea-Index (AHI) of 39 (31-56)/h, residual AHI flow was 1.9 (0.9-4) events/h), CPAP-treatment lasted 4.4 (2.0-9.7) years, CPAP-usage was 6.8 (5.5-7.8) h/day, the prevalence of CPAP-non-adherence was 8.6%, and the prevalence of RES was 16.17%. Leak-related side-effects were the most prevalent side-effects (patient-reported leaks concerned 75.4% of responders and had no correlation with CPAP-reported-leaks). Multivariable logistic regression analyses evaluating explanatory-variable (demographic data, device/mask data and MRSEs) effects on variables-of-interest (CPAP-non-adherence and RES), indicated for patient-MRSEs significant associations between: (i) CPAP-non-adherence and dry-mouth (p = 0.004); (ii) RES and patient-reported leaks (p = 0.007), noisy mask (p < 0.001), dry nose (p < 0.001) and harness pain (p = 0.043)., Conclusion: In long-term CPAP-treated patients, leak-related side-effects remain the most prevalent side-effects, but patient-reported leaks cannot be predicted by CPAP-reported-leaks. Patient-MRSEs can be independently associated with CPAP-non-adherence and RES, thus implying a complementary role for MRSE questionnaires alongside CPAP-device-reported-data for patient monitoring. Trial registration InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).

Published
2021
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47. CD25-targeted antibody-drug conjugate depletes regulatory T cells and eliminates established syngeneic tumors via antitumor immunity.

Author

Zammarchi F, Havenith K, Bertelli F, Vijayakrishnan B, Chivers S, and van Berkel PH

Subjects
Cell Line, Tumor, Humans, Immunoconjugates pharmacology, Neoplasms pathology, Tumor Microenvironment, Immunoconjugates therapeutic use, Immunotherapy methods, Interleukin-2 Receptor alpha Subunit metabolism, Neoplasms genetics, T-Lymphocytes, Regulatory immunology
Abstract

Background: Regulatory T cells (T regs ) contribute to an immunosuppressive tumor microenvironment. They play an important role in the establishment and progression of tumors with high T regs infiltration and present a major obstacle to tumor eradication by immunotherapies. Numerous strategies have been attempted to deplete or block T regs , although their success has been limited., Methods: A CD25-targeted, pyrrolobenzodiazepine (PBD) dimer-based antibody-drug conjugate (ADC) was investigated for its ability to deplete T regs and induce antitumor immunity. Antitumor activity of CD25-ADC either alone or in combination with an anti-programmed cell death protein 1 (PD-1) antibody was evaluated in CD25-negative syngeneic models that exhibit tumor infiltration of CD25-expressing T regs , and its pharmacodynamics and pharmacokinetics were assessed., Results: Single low doses of CD25-ADC resulted in potent and durable antitumor activity in established syngeneic solid tumor models and the combination of a suboptimal dose was synergistic with PD-1 blockade. Tumor eradication by the CD25-targeted ADC was CD8+ T cell-dependent and CD25-ADC induced protective immunity. Importantly, while CD25-ADC mediated a significant and sustained intratumoral T regs depletion, accompanied by a concomitant increase in the number of activated and proliferating tumor-infiltrating CD8+ T effector cells, systemic T regs depletion was transient, alleviating concerns of potential autoimmune side effects., Conclusions: This study shows that a PBD dimer-based, CD25-targeted ADC is able to deplete T regs and eradicate established tumors via antitumor immunity. This represents a novel approach to efficiently deplete T regs via a very potent DNA damaging toxin known to induce immunogenic cell death. Moreover, this study provides proof of concept for a completely new application of ADCs as immunotherapeutic agents, as the main mode of action relies on the ADC directly targeting immune cells, rather than tumor cells. These strong preclinical data warrant the clinical evaluation of camidanlumab tesirine (ADCT-301), a PBD-based ADC targeting human CD25, either alone or in combination with checkpoint inhibitors in solid tumors with known T regs infiltration. A phase I trial (NCT03621982) of camidanlumab tesirine in patients with selected advanced solid tumors is ongoing., Competing Interests: Competing interests: FZ, KH and PHvB are employees of ADC Therapeutics and shareholders. SC was employed by ADC Therapeutics during the conduct of the study and a shareholder. FB was employed by AstraZeneca during the conduct of the study. BV is an AstraZeneca employee and currently holds share ownership/options., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2020
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48. Surgery for Adult Patients with Congenital Heart Disease: Results from the European Database.

Author

Vida VL, Zanotto L, Torlai Triglia L, Zanotto L, Maruszewski B, Tobota Z, Bertelli F, Cattapan C, Ebels T, Bottigliengo D, Gregori D, Sarris G, Horer J, Stellin G, Padalino MA, Di Salvo G, and On The Behalf Of The European Congenital Heart Surgeons Association Echsa

Abstract

Adults with congenital heart disease (ACHD) represent a growing population. To evaluate frequency, type and outcomes of cardiac surgery in ACHD, we gathered data from the European Congenital Heart Surgeons Association Database of 20,602 adult patients (≥18 years) with a diagnosis of congenital heart disease who underwent cardiac surgery, between January 1997 and December 2017. We demonstrated that overall surgical workload (as absolute frequencies of surgical procedures per year) for this specific subset of patients increased steadily during the study period. The most common procedural groups included septal defects repair ( n = 5740, 28%), right-heart lesions repair ( n = 5542, 27%) and left-heart lesions repair ( n = 4566, 22%); almost one-third of the procedures were re-operations ( n = 5509, 27%). When considering the year-by-year relative frequencies of the main procedural groups, we observed a variation of the surgical scenario during the last two decades, characterized by a significant increase over time for right and left-heart lesions repair ( p < 0.0001, both); while a significant decrease was seen for septal defects repair ( p < 0.0001) and transplant ( p = 0.03). Overall hospital mortality was 3% ( n = 622/20,602 patients) and was stable over time. An inverse relationship between mortality and the number of patients operated in each center ( p < 0.0001) was observed.

Published
2020
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49. Late management of the aortic root after repair of tetralogy of Fallot: A European multicentre study.

Author

Vida VL, Triglia LT, Zanotto L, Zanotto L, Bertelli F, Padalino M, Sarris G, Protopapas E, Prospero C, Pizarro C, Cleuziou J, Myers PO, Prêtre R, Poncelet AJ, Meyns B, Van den Bossche K, Accord RE, Gil-Jaurena JM, Sakurai T, and Stellin G

Subjects
Adult, Aorta pathology, Child, Child, Preschool, Dilatation, Pathologic, Female, Follow-Up Studies, Humans, Male, Reoperation, Time Factors, Treatment Outcome, Aorta surgery, Aortic Valve surgery, Aortic Valve Insufficiency surgery, Heart Valve Prosthesis Implantation, Tetralogy of Fallot surgery
Abstract

Objectives: We sought to determine the indications, type, and outcomes of reoperations on the aortic root after repair of tetralogy of Fallot (TOF)., Methods: Eleven centers belonging to the European Congenital Heart Surgeons Association contributed to the data collection process. We included 36 patients who underwent surgical procedures on the aortic root, including surgery on the aortic valve and ascending aorta, between January 1975 and December 2017. Original diagnoses included TOF-pulmonary stenosis (n = 18) and TOF-pulmonary atresia (n = 18). The main indications for reoperation were aortic insufficiency (n = 19, 53%), aortic insufficiency and dilatation of the ascending aorta (n = 10, 28%), aortic root dilatation (n = 4, 11%), and ascending aorta dilatation (n = 3, 8%)., Results: The median age at reoperation was 30.4 years (interquartile range 20.3-45.3 years), and mechanical aortic valve replacement was the most common procedure performed. Five patients died early after reoperation (14%), and larger ascending aorta diameters were associated with early mortality (P = .04). The median age at the last follow-up was 41.4 years (interquartile range 24.5-51.6 years). Late death occurred in five patients (5/31, 16%). Most survivors (15/26, 58%) were asymptomatic at the last clinical examination (New York Heart Association, NYHA class I). The remaining patients were NYHA class II (n = 7) and III (n = 3). The most common symptoms were fatigue (n = 5), dyspnea (n = 4), and exercise intolerance (n = 3)., Conclusions: Reoperations on the aortic root are infrequent but may become necessary late after TOF repair. The main indications for reoperation are aortic insufficiency, either isolated or associated with a dilatation of the ascending aorta. The surgical risk at reoperation was high and the presence of ascending aorta dilation is related to higher mortality., (© 2019 Wiley Periodicals, Inc.)

Published
2020
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50. Antitumor Activity of MEDI3726 (ADCT-401), a Pyrrolobenzodiazepine Antibody-Drug Conjugate Targeting PSMA, in Preclinical Models of Prostate Cancer.

Author

Cho S, Zammarchi F, Williams DG, Havenith CEG, Monks NR, Tyrer P, D'Hooge F, Fleming R, Vashisht K, Dimasi N, Bertelli F, Corbett S, Adams L, Reinert HW, Dissanayake S, Britten CE, King W, Dacosta K, Tammali R, Schifferli K, Strout P, Korade M 3rd, Masson Hinrichs MJ, Chivers S, Corey E, Liu H, Kim S, Bander NH, Howard PW, Hartley JA, Coats S, Tice DA, Herbst R, and van Berkel PH

Subjects
Animals, Antigens, Surface genetics, Antigens, Surface metabolism, Cell Line, Tumor, Cross Reactions immunology, Disease Models, Animal, Drug Evaluation, Preclinical, Gene Expression, Glutamate Carboxypeptidase II genetics, Glutamate Carboxypeptidase II metabolism, Humans, Immunohistochemistry, Macaca fascicularis, Male, Mice, Prostatic Neoplasms pathology, Xenograft Model Antitumor Assays, Antineoplastic Agents, Immunological pharmacology, Biomarkers, Tumor antagonists & inhibitors, Glutamate Carboxypeptidase II antagonists & inhibitors, Immunoconjugates pharmacology, Prostatic Neoplasms drug therapy, Prostatic Neoplasms immunology
Abstract

Prostate-specific membrane antigen (PSMA) is a membrane-bound glutamate carboxypeptidase that is highly expressed in nearly all prostate cancers with the highest expression in metastatic castration-resistant prostate cancer (mCRPC). The prevalence of increased surface expression and constitutive internalization of PSMA make it an attractive target for an antibody-drug conjugate (ADC) approach to treating patients with mCRPC. MEDI3726 (previously known as ADCT-401) is an ADC consisting of an engineered version of the anti-PSMA antibody J591 site specifically conjugated to the pyrrolobenzodiazepine (PBD) dimer tesirine. MEDI3726 specifically binds the extracellular domain of PSMA and, once internalized, releases the PBD dimer to crosslink DNA and trigger cell death. In vitro , MEDI3726 demonstrated potent and specific cytotoxicity in a panel of PSMA-positive prostate cancer cell lines, consistent with internalization and DNA interstrand crosslinking. In vivo , MEDI3726 showed robust antitumor activity against the LNCaP and the castration-resistant CWR22Rv1 prostate cancer cell line xenografts. MEDI3726 also demonstrated durable antitumor activity in the PSMA-positive human prostate cancer patient-derived xenograft (PDX) LuCaP models. This activity correlated with increased phosphorylated Histone H2AX in tumor xenografts treated with MEDI3726. MEDI3726 is being evaluated in a phase I clinical trial as a treatment for patients with metastatic castrate-resistant prostate cancer (NCT02991911). Mol Cancer Ther; 17(10); 2176-86. ©2018 AACR ., (©2018 American Association for Cancer Research.)

Published
2018
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