Aims A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. Methods and results We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17-0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30-0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50-1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. Conclusion Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks.
Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case-control study / Botto, G. L.; Ziacchi, M.; Nigro, G.; D'Onofrio, A.; Dello Russo, A.; Francia, P.; Viani, S.; Pisano, E.; Bisignani, G.; Caravati, F.; Migliore, F.; De Filippo, P.; Ottaviano, L.; Rordorf, R.; Manzo, M.; Canevese, F. L.; Lovecchio, M.; Valsecchi, S.; Checchi, L.; Casale, M. C.; Schintu, B.; Scalone, A.; Tola, G.; Setzu, A.; Curcio, A.; Santoro, A.; Baiocchi, C.; Gentilini, R.; Lunghetti, S.; Solimene, F.; Shopova, G.; Schillaci, V.; Arestia, A.; Agresta, A.; Bianchi, S.; Rossi, P.; Cauti, F. M.; La Greca, C.; Pecora, D.; Ammirati, F.; Santini, L.; Mahfouz, K.; Colaiaco, C.; Vicentini, A.; Savastano, S.; Petracci, B.; Sanzo, A.; Baldi, E.; Casula, M.; Perego, G. B.; Rella, V.; Bianchi, V.; Tavoletta, V.; De Vivo, S.; Palmisano, P.; Accogli, M.; Milanese, G.; Pepi, P.; Nicolis, D.; Mariani, M.; Pagani, M.; Bonfantino, M. V.; Caccavo, V.; Grimaldi, M.; Katsouras, G.; Forleo, G. B.; Chieffo, E.; Tavarelli, E.; Brambilla, R.; Pani, A.; Giammaria, M.; Lucciola, M. T.; Amellone, C.; Uran, C.; Baroni, M.; Ferrari, P.; Leidi, C.; Drago, F.; Silvetti, M. S.; Pazzano, V.; Russo, S.; Remoli, R.; Battipaglia, I.; Cazzoli, I.; Saputo, F.; Devecchi, C.; Barbonaglia, L.; Viscusi, M.; Brignoli, M.; Mattera, A.; Pedretti, S.; Lupi, A.; Tommasi, S.; Kol, A.; Gatto, M. C.; Persi, A.; Gonella, A.; Rossetti, G.; Menardi, E.; Rossini, R.; Notarstefano, P.; Nesti, M.; Fraticelli, A.; Carreras, G.; Donzelli, S.; Marini, C.; Tordini, A.; Lazzari, L.; Sartori, P.; Di Donna, P.; Mascia, G.; Capogrosso, P.; Magliano, P.; Colimodio, M.; Sala, S.; Mazzone, P.; Della Bella, P.; Coppolino, A.; Arena, G.; Borrello, V.; Ratti, M.; Bartoli, C.; Palano, F.; Adduci, C.; Torriglia, A.; Laffi, M.; Esposito, C.; Giano, A.; Franculli, F.; Pangallo, A.; De Bonis, S.; Sarubbi, B.; Colonna, D.; Correra, A.; Romeo, E.; Rapacciuolo, A.; Liguori, V.; Viggiano, A.; Strisciullo, T.; Biffi, M.; Diemberger, I.; Martignani, C.; Piro, A.; Lavalle, C.; Magnocavallo, M.; Mariani, M. V.; Ricciardi, D.; Calabrese, V.; Gioia, F.; Picarelli, F.; Licciardello, G.; Busacca, G.; Calvi, V. I.; Lamberti, F.; Lumia, G.; Bellini, C.; Bianchi, C.; Savarese, G.; Andreoli, C.; Pimpinicchio, L.; Pellegrini, D.; Giorgi, D.; Bovenzi, ; Busoni, F.; Daleffe, E.; Facchin, D.; Rebellato, L.; Stifano, G.; Magliano, G.; Sergi, D.; Barone, L.; Morgagni, R.; Casella, M.; Guerra, F.; Cipolletta, L.; Molini, S.; De Lucia, R.; Di Cori, A.; Grifoni, G.; Paperini, L.; Segreti, L.; Soldati, E.; Zucchelli, G.; Russo, V.; Rago, A.; Ammendola, E.; Papa, A.; Pieragnoli, P.; Ricciardi, G.; Perrotta, L.. - In: EUROPACE. - ISSN 1099-5129. - 25:4(2023), pp. 1423-1431. [10.1093/europace/euad028]
Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case-control study
Nigro G.;Pisano E.;Migliore F.;Ottaviano L.;Curcio A.;Solimene F.;La Greca C.;Savastano S.;Milanese G.;Pagani M.;Ferrari P.;Drago F.;Viscusi M.;Lupi A.;Tommasi S.;Rossetti G.;Di Donna P.;Mascia G.;Sala S.;De Bonis S.;Sarubbi B.;Colonna D.;Rapacciuolo A.;Piro A.;Ricciardi D.;Picarelli F.;Bianchi C.;Magliano G.;Zucchelli G.;Rago A.;Ammendola E.;Perrotta L.
2023
Abstract
Aims A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. Methods and results We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17-0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30-0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50-1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. Conclusion Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
