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Safety of Omitting Defibrillation Efficacy Testing With Subcutaneous Defibrillators: A Propensity-Matched Case-Control Study

2021; Lippincott Williams & Wilkins; Volume: 14; Issue: 12 Linguagem: Inglês

10.1161/circep.121.010381

1941-3149

Valter Bianchi, Giovanni Bisignani, Federico Migliore, Mauro Biffi, Gerardo Nigro, Stefano Viani, Fabrizio Caravati, Luca Checchi, Pietro Francia, Paolo De Filippo, Domenico Pecora, Carlo Lavalle, Antonio Scalone, Pietro Rossi, Pietro Palmisano, Giovanni Licciardello, Roberto Ospizio, Mariolina Lovecchio, Sergio Valsecchi, Antonio D’Onofrio, Augusto D’Onofrio, Vincenzo Tavoletta, Stefano De Vivo, Paolo Pieragnoli, G. Ricciardi, Laura Perrotta, Luca Ottaviano, Igor Diemberger, Matteo Ziacchi, Cristian Martignani, Vincenzo Russo, Angela Rago, Ernesto Ammendola, Maria Grazia Bongiorni, R. De Lucia, Andrea Di Cori, L Paperini, Luca Segreti, Ezio Soldati, Giulio Zucchelli, Francesca Palano, Carmen Adduci, Paolo Ferrari, Cristina Leidi, Arcangelo Russo, Michela Casella, Federico Guerra, Laura Cipolletta, Silvano Molini, Stefano Pedretti, Massimo Giammaria, MT. Lucciola, C. Amellone, Michele Accogli, B Schintu, Gianfranco Tola, Alessio Setzu, Ennio Pisanò, Giulio Milanese, Silvana De Bonis, Carmelo La Greca, Berardo Sarubbi, Diego Colonna, Emanuele Romeo, Simone Sala, Patrizio Mazzone, Paolo Della Bella, Miguel Viscusi, D. Maggio, Marcello Brignoli, Fabrizio Drago, Massimo Stefano Silvetti, R. Brambilla, Antonio Pani, Alessandro Lupi, G. Carreras, Sonia Donzelli, Corrado P. Marini, A Tordini, Emanuela Racca, Anna Gonella, G. Musumeci, Guido Rossetti, Endrj Menardi, Gianpaolo Ballari, Fabrizio Ammirati, Luca Santini, Karim Mahfouz, Carlo Colaiaco, GB. Perego, Valeria Rella, Giovanni Bertero, P. Sartori, Antonio Rapacciuolo, Vincenzo Liguori, A. Viggiano, G Busacca, Gianluca Savarese, Chiara Andreoli, L. Pimpinicchio, Dario Pellegrini, Giuseppe Stifano, Francesco Romeo, Domenico Sergi, Sandra Badolati, P. Pepi, Daniele Nicolis, Roberto Rordorf, Alessandro Vicentini, Simone Savastano, Barbara Petracci, Antonio Sanzo, Enrico Baldi, Manuela Casula, F. Solimene, G. Shopova, V. Schillaci, Alberto Arestia, Alessia Agresta, Agostino Piro, G.B. Forleo, Antonio Pangallo, Michele Manzo, C. Esposito, Francesco Esposito, Antonio Curcio, Danilo Ricciardi, Vincenzo Calabrese, Davide Giorgi, Bovenzi, F Busoni, Antonella Torriglia, Mattia Laffi, Germano Gaggioli, Giuseppe Arena, V. Molendi, V. Borrello, M Ratti, Cesare Bartoli, Paolo Capogrosso, Mario Volpicelli, Gregorio Covino, Massimo Mariani, Michele Pagani, Pasquale Notarstefano, Martina Nesti, Emilio Vincenzo Dovellini, Letizia Giurlani, M. Landolina, E. Tavarelli, Stefano Bianchi, Carlo Uran, Massimo Vincenzo Bonfantino, Elisabetta Daleffe, D. Facchin, Luca Rebellato, Vincenzo Caccavo, M. Grimaldi, Grigorios Katsouras, A. Coppolino, F. Lamberti, Giuseppe Lumia, Chiara Bellini, Camilla Bianchi, Amato Santoro, C. Baiocchi, R Gentilini, Stefano Lunghetti, Valerio Zacà,

Cardiac Arrhythmias and Treatments

HomeCirculation: Arrhythmia and ElectrophysiologyVol. 14, No. 12Safety of Omitting Defibrillation Efficacy Testing With Subcutaneous Defibrillators: A Propensity-Matched Case-Control Study LetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toLetterPDF/EPUBSafety of Omitting Defibrillation Efficacy Testing With Subcutaneous Defibrillators: A Propensity-Matched Case-Control Study Valter Bianchi, MD, Giovanni Bisignani, MD, Federico Migliore, MD, Mauro Biffi, MD, Gerardo Nigro, MD, Stefano Viani, MD, Fabrizio Caravati, MD, Luca Checchi, MD, Pietro Francia, MD, Paolo De Filippo, MD, Domenico Pecora, MD, Carlo Lavalle, MD, Antonio Scalone, MD, Pietro Rossi, MD, Pietro Palmisano, MD, Giovanni Licciardello, MD, Roberto Ospizio, MS, Mariolina Lovecchio, MS, Sergio Valsecchi, PhD and Antonio D'Onofrio, MD Valter BianchiValter Bianchi Correspondence to: Valter Bianchi, MD, Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie, Azienda Ospedaliera dei Colli–Monaldi, Via Leonardo Bianchi, 1, 80131 Naples, Italy. Email E-mail Address: [email protected] https://orcid.org/0000-0003-2678-7836 "Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie", Monaldi Hospital, Naples, Italy (V.B., A.D.). , Giovanni BisignaniGiovanni Bisignani Division of Cardiology, Castrovillari Hospital, Cosenza, Italy (G.B.). , Federico MiglioreFederico Migliore https://orcid.org/0000-0001-8574-9421 Division of Cardiology, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy (F.M.). , Mauro BiffiMauro Biffi https://orcid.org/0000-0003-4590-8584 Department of Experimental, Diagnostic and Specialty Medicine, Institute of Cardiology, University of Bologna, Policlinico S.Orsola-Malpighi, Italy (M.B.). , Gerardo NigroGerardo Nigro https://orcid.org/0000-0003-1776-8449 Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli," Monaldi Hospital, Naples, Italy (G.N.). , Stefano VianiStefano Viani Second Cardiology Division, Cardio-Thoracic and Vascular Department, University Hospital of Pisa, Italy (S.V.). , Fabrizio CaravatiFabrizio Caravati https://orcid.org/0000-0001-6343-6352 Ospedale di Circolo e Fondazione Macchi, Varese, Italy (F.C.). , Luca ChecchiLuca Checchi University of Florence, Italy (L.C.). , Pietro FranciaPietro Francia Division of Cardiology, Department of Clinical and Molecular Medicine, Sapienza University, St. Andrea Hospital, Rome, Italy (P.F.). , Paolo De FilippoPaolo De Filippo https://orcid.org/0000-0002-1144-5000 Papa Giovanni XXIII Hospital, Bergamo, Italy (P.D.F.). , Domenico PecoraDomenico Pecora https://orcid.org/0000-0003-2318-3818 Unità di Elettrofisiologia, Dipartimento Cardiovascolare, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy (D.P.). , Carlo LavalleCarlo Lavalle Department of Cardiovascular Disease, Policlinico Umberto I Hospital, Rome, Italy (C.L.). , Antonio ScaloneAntonio Scalone Division of Cardiology, A.O. Brotzu, Cagliari, Italy (A.S.). , Pietro RossiPietro Rossi Fatebenefratelli Hospital, Rome, Italy (P.R.). , Pietro PalmisanoPietro Palmisano "Card. G. Panico" Hospital, Tricase, Lecce, Italy (P.P.). , Giovanni LicciardelloGiovanni Licciardello https://orcid.org/0000-0002-6659-5348 Ospedale E. Muscatello, Augusta, Italy (G.L.). , Roberto OspizioRoberto Ospizio Boston Scientific, Milan, Italy (R.O., M.L., S.V.). , Mariolina LovecchioMariolina Lovecchio Boston Scientific, Milan, Italy (R.O., M.L., S.V.). , Sergio ValsecchiSergio Valsecchi https://orcid.org/0000-0001-7055-6942 Boston Scientific, Milan, Italy (R.O., M.L., S.V.). and Antonio D'OnofrioAntonio D'Onofrio "Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie", Monaldi Hospital, Naples, Italy (V.B., A.D.). and on behalf of "S-ICD Rhythm Detect" Investigators Originally published2 Dec 2021https://doi.org/10.1161/CIRCEP.121.010381Circulation: Arrhythmia and Electrophysiology. 2021;14Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: December 2, 2021: Ahead of Print The noninferiority of defibrillation testing (DT) omission at the time of implantation was demonstrated in transvenous implantable cardioverter defibrillators (ICD).1 Thus, guidelines included DT omission during implantation of transvenous ICDs.2 The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD,3 but it still requires DT.2 We evaluated the outcome of S-ICD patients with omitted DT in comparison with those who had undergone DT per physician's discretion. From 2013 to 2019, consecutive patients undergoing S-ICD implantation (Boston Scientific, Inc, Natick, MA) were enrolled at 60 Italian centers. Patients were followed up until 2020 within the framework of a prospective registry (REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02275637). The Institutional Review Boards approved the study, and all patients provided informed consent. The study data are available from the corresponding author upon reasonable request. The composite primary end point consisted of all-cause death and ineffective S-ICD therapy. The secondary end point was the composite of all-cause death, ineffective shock, inappropriate shock, and complication. We implemented 1:1 nearest neighbor propensity score matching without replacement, with propensity score estimated using logistic regression of the treatment on the covariates. The variables considered for propensity score calculation were sex, age, body mass index, and ejection fraction. A total of 1652 S-ICD procedures were performed within the observation period. Defibrillation testing was performed in 1300 patients and omitted in 325 patients (27 patients excluded because of incomplete data). The median proportion of patients who underwent DT at the study centers was 86% (25th–75th percentile: 71%–96%). Cardioversion at shock energy of ≤65J was successful in 1225 (94.2%) and ineffective in 33 (2.6%). Forty-two patients were successfully tested at initial shock energy of >65J. Overall, successful cardioversion was achieved with ≤80J shocks in 1298 (99.8%) patients. In the 1300 patients with DT, 2 (0.15%) episodes of electromechanical dissociation (1 fatal) because of testing were reported. DT-omitted patients were more frequently female (79 [24%] versus 247 [19%], P=0.033), were older (51±16 versus 48±15 years, P=0.001), and had higher body mass index (26±5 versus 25±4 kg/m2, P=0.024). Moreover, DT-omitted patients more frequently had dilated cardiomyopathy with reduced ejection fraction (38±16% versus 46±16%, P 90%) of successful conversion on DT with S-ICDs.3 We confirmed this finding, as we recorded a conversion rate of 94.2% with 65J shock energy in a large unselected population, and a high rate of conversion of clinical ventricular arrhythmias during follow-up. Previous studies have found that adherence to the DT recommendation is declining in clinical practice and that testing is frequently omitted in patients who are at higher risk of complications.4 We confirmed this finding. Indeed, DT was more frequently omitted in patients with more severe systolic dysfunction.The rate of the combined end point was low, and we did not observe a higher risk associated with DT omission. Moreover, we did not observe an association between the risk of the secondary end point and the DT group assignment. Overall, 5.5% of patients received inappropriate shocks (5.8% received appropriate shocks). Moreover, complications were rare and not associated with the group assignment. Nonetheless, in the wider unselected population, we observed 2 serious adverse events and one DT-associated death. Our analysis did not show any interaction between baseline variables and the primary and secondary end points. Nonetheless, some factors have previously proved to be associated with lower shock efficacy and should be considered in the decisional process, as still happens in the case of transvenous ICDs for patients at high risk of elevated defibrillation threshold (eg, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, right-sided implantation), for which DT is still recommended.2In conclusion, DT is frequently omitted in current clinical practice, especially in older patients with worse systolic function. Omitting DT does not compromise the effectiveness of the S-ICD, and no additional risk seems to be associated with DT omission in a patient population resembling the analyzed cohort. However, the observational design of the study may have introduced an inherent bias. The findings of an ongoing randomized trial will confirm our results.5Article InformationSources of FundingNone.APPENDIXList of participating centres: Monaldi Hospital, Naples: A. D'Onofrio, V. Bianchi; V. Tavoletta, S. De Vivo; University of Florence, Florence: P. Pieragnoli, G. Ricciardi, L. Checchi, L. Perrotta; Istituto Clinico Sant'Ambrogio, Milan: L. Ottaviano; Policlinico S.Orsola-Malpighi, Bologna: M. Biffi, I. Diemberger, M. Ziacchi, C. Martignani; Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples: G. Nigro, V. Russo, A. Rago, E. Ammendola; University Hospital of Pisa, Pisa: M.G. Bongiorni, R. De Lucia, A. Di Cori, L. Paperini, L. Segreti, E. Soldati, S. Viani, G. Zucchelli; University of Padua: F. Migliore; Ospedale St. Andrea, Rome: P. Francia, F. Palano, C. Adduci; Ospedale Papa Giovanni XXIII, Bergamo: P. De Filippo; P. Ferrari; C. Leidi; Università Politecnica delle Marche, Ancona: A. Dello Russo, M. Casella, F. Guerra, L. Cipolletta; S. Molini; Ospedale S. Anna, Como: S. Pedretti; Ospedale Maria Vittoria, Turin: M. Giammaria, M.T. Lucciola, C. Amellone; Ospedale "G. Panico", Tricase, Lecce: P. Palmisano; M. Accogli; Azienda ospedaliera "G. Brotzu", Cagliari: B. Schintu, A. Scalone, G. Tola, A. Setzu; Ospedale "Vito Fazzi", Lecce: E. Pisanò, G. Milanese; P.O. Ferrari, Castrovillari, Cosenza: G. Bisignani, S. De Bonis; Fondazione Poliambulanza, Brescia: C. La Greca, D. Pecora; Paediatric Cardiology Unit, Second University of Naples, Naples: B. Sarubbi, D. Colonna, E. Romeo; Ospedale San Raffaele, Milan: S. Sala, P. Mazzone, P. Della Bella; Ospedale S. Anna e S. Sebastiano, Caserta: M. Viscusi, D. Di Maggio, M. Brignoli; Ospedale Pediatrico "Bambino Gesù", Palidoro, Fiumicino: F. Drago, M.S. Silvetti; Ospedale Manzoni, Lecco: R. Brambilla, A. Pani; Ospedale S. Biagio, Domodossola: A Lupi; Ospedale S. Maria, Terni: G. Carreras, S. Donzelli, C. Marini, A. Tordini; Circolo e Fondazione Macchi, Varese: F. Caravati; Ospedale S. Croce e Carle, Cuneo: E. Racca, A. Gonella, G. Musumeci, G. Rossetti, E, Menardi, G. P. Ballari; 'Giovan Battista Grassi' Hospital, Rome; F. Ammirati, L. Santini, K. Mahfouz, C. Colaiaco; Istituto Auxologico Italiano – IRCCS, Milan: GB. Perego, V. Rella; Ospedale S. Martino, Genova: G. Bertero, P. Sartori, P. Rossi; Policlinico Federico II, Naples: A. Rapacciuolo, V. Liguori, A. Viggiano; Presidio Ospedaliero Muscatello, Augusta (SR): G. Licciardello, G. Busacca; 'San Giovanni Battista' Hospital, Foligno: G. Savarese, C. Andreoli, L. Pimpinicchio, D. Pellegrini; Ospedale S. Camillo de Lellis, Rieti: G. Stifano; Università di Tor Vergata, Rome: F. Romeo, D. Sergi; Ospedale S. Andrea, La Spezia: S. Badolati; Ospedale Carlo Poma, Mantova: P. Pepi, D. Nicolis; IRCCS Fondazione Policlinico 'S. Matteo', Pavia: R. Rordorf, A. Vicentini, S. Savastano, B. Petracci, A. Sanzo, E. Baldi, M. Casula; Clinica Montevergine, Mercogliano (AV): F. Solimene, G. Shopova, V. Schillaci, A. Arestia, A. Agresta; Policlinico Umberto I, Rome: A. Piro; C. Lavalle; Ospedale Luigi Sacco, Milan: GB. Forleo; Ospedali Riuniti, Reggio Calabria: A. Pangallo; Ospedali Riuniti San Giovanni di Dio e Ruggi d'Aragona, Salerno: M. Manzo; C. Esposito, F. Esposito; Azienda Ospedaliera Mater Domini, Catanzaro: A. Curcio; Policlinico Universitario Campus Bio-Medico, Rome: D. Ricciardi; V. Calabrese; 'San Luca' Hospital, Lucca: D. Giorgi, Bovenzi, F. Busoni; Ospedale Villa Scassi, Genova: A. Torriglia, M. Laffi, G. Gaggioli; Ospedale SS. Giacomo e Cristoforo, Massa: G. Arena, V. Molendi, V. Borrello, M. Ratti, C. Bartoli; Ospedale San Giovanni Bosco, Naples: P. Capogrosso, M. Volpicelli, G. Covino; Ospedale di Legnano, Milan: M. Mariani, M. Pagani; Ospedale S. Donato, Arezzo: P. Notarstefano, M. Nesti; Ospedale Careggi, Florence: E. Dovellini; L. Giurlani; Ospedale Maggiore, Crema: M. Landolina, E. Tavarelli; Fatebenefratelli Hospital, Rome: S. Bianchi, P. Rossi; Ospedale Melorio, Santa Maria Capua Vetere, Caserta: C. Uran; Ospedale Di Venere, Carbonara di Bari, Bari: Massimo Vincenzo Bonfantino; Santa Maria della Misericordia, Udine: E. Daleffe, D. Facchin, L Rebellato; Ospedale F. Miulli, Acquaviva delle Fonti, Bari: V. Caccavo, M. Grimaldi, G. Katsouras; Ospedale SS. Annunziata, Savigliano, Cuneo: A. Coppolino; 'San Eugenio' Hospital, Rome; F. Lamberti, G. Lumia, C. Bellini, C. Bianchi; Azienda Ospedaliera Universitaria Senese, Siena, Italy: A Santoro, C Baiocchi, R Gentilini, S Lunghetti, V Zacà.Nonstandard Abbreviations and AcronymsDTdefibrillation testingICDimplantable cardioverter defibrillatorS-ICDsubcutaneous ICDDisclosures This was an independent study. Dr De Filippo received speaker's fees and educational grants from Boston Scientific and research grants from Abbott. R. Ospizio, M. Lovecchio, and Dr Valsecchi are employees of Boston Scientific. The other authors report no conflicts.FootnotesFor Sources of Funding and Disclosures, see page 1094.*A list of all S-ICD Rhythm Detect Investigators is given in the Appendix.Correspondence to: Valter Bianchi, MD, Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie, Azienda Ospedaliera dei Colli–Monaldi, Via Leonardo Bianchi, 1, 80131 Naples, Italy. Email valter.[email protected]comReferences1. Healey JS, Hohnloser SH, Glikson M, Neuzner J, Mabo P, Vinolas X, Kautzner J, O'Hara G, VanErven L, Gadler F, et al; Shockless IMPLant Evaluation [SIMPLE] investigators. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE).Lancet. 2015; 385:785–791. doi: 10.1016/S0140-6736(14)61903-6CrossrefMedlineGoogle Scholar2. Wilkoff BL, Fauchier L, Stiles MK, Morillo CA, Al-Khatib SM, Almendral J, Aguinaga L, Berger RD, Cuesta A, Daubert JP, et al; Document Reviewers. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing.Europace. 2016; 18:159–183. doi: 10.1093/europace/euv411CrossrefMedlineGoogle Scholar3. Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, et al; EFFORTLESS Investigator Group. Implant and midterm outcomes of the subcutaneous implantable cardioverter-defibrillator registry: the EFFORTLESS study.J Am Coll Cardiol. 2017; 70:830–841. doi: 10.1016/j.jacc.2017.06.040CrossrefMedlineGoogle Scholar4. Friedman DJ, Parzynski CS, Varosy PD, Prutkin JM, Patton KK, Mithani A, Russo AM, Curtis JP, Al-Khatib SM. Trends and in-hospital outcomes associated with adoption of the subcutaneous implantable cardioverter defibrillator in the United States.JAMA Cardiol. 2016; 1:900–911. doi: 10.1001/jamacardio.2016.2782CrossrefMedlineGoogle Scholar5. Quast ABE, Baalman SWE, Betts TR, Boersma LVA, Bonnemeier H, Boveda S, Brouwer TF, Burke MC, Delnoy PPHM, El-Chami M, et al. Rationale and design of the PRAETORIAN-DFT trial: a prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing.Am Heart J. 2019; 214:167–174. doi: 10.1016/j.ahj.2019.05.002CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails December 2021Vol 14, Issue 12 Advertisement Article InformationMetrics © 2021 The Authors. Circulation: Arrhythmia and Electrophysiology is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited and is not used for commercial purposes.https://doi.org/10.1161/CIRCEP.121.010381PMID: 34852635 Originally publishedDecember 2, 2021 Keywordsdefibrillator, implantablearrhythmias, cardiaccause of deathpropensity scoreventricular fibrillationPDF download Advertisement SubjectsCatheter Ablation and Implantable Cardioverter-Defibrillator