Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID- 19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. Journal Pre-proof Discontinuation of maintenance electroconvulsive therapy: lessons learned from the COVID-19 pandemic Erika Martı́nez-Amorós Pilar Serra Adriana Bassa Diego J. Palao Narcı́s Cardoner PII: S1888-9891(21)00090-2 DOI: https://doi.org/doi:10.1016/j.rpsm.2021.07.005 Reference: RPSM 555 To appear in: Revista de psiquiatrı́a y salud mental (Barcelona) Received Date: 21 March 2021 Please cite this article as: Martı́nez-Amorós E, Serra P, Bassa A, Palao DJ, Cardoner N, Discontinuation of maintenance electroconvulsive therapy: lessons learned from the COVID-19 pandemic, Revista de psiquiatrı́a y salud mental (Barcelona) (2021), doi: https://doi.org/10.1016/j.rpsm.2021.07.005 This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier. DISCONTINUATION OF MAINTENANCE ELECTROCONVULSIVE THERAPY: LESSONS LEARNED FROM THE COVID-19 PANDEMIC DISCONTINUACIÓN DE LA TERAPIA ELECTROCONVULSIVA DE MANTENIMIENTO: LECCIONES APRENDIDAS DE LA PANDEMIA DE COVID-19 Title: DISCONTINUATION OF MAINTENANCE ELECTROCONVULSIVE THERAPY: LESSONS LEARNED FROM THE COVID-19 PANDEMIC of DISCONTINUACIÓN DE LA TERAPIA ELECTROCONVULSIVA DE ro MANTENIMIENTO: LECCIONES APRENDIDAS DE LA PANDEMIA COVID-19 -p Authors and affiliations: re Erika Martínez-Amorósa,b, Pilar Serraa, Adriana Bassaa, Diego J. Palaoa,b, Narcís Cardonera,b*. lP a Department of Mental Health, Parc Taulí University Hospital. Institut d’Investigació i na Innovació Sanitària Parc Taulí (I3PT). Department of Psychiatry and Forensic Medicine, Universitat Autònoma de Barcelona, Spain. ur b Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Carlos III Health Institute, Spain. Jo Erika Martínez-Amorós: emartineza@tauli.cat Pilar Serra: pserram@tauli.cat Adriana Bassa: abassa@tauli.cat Diego J Palao: DPalao@tauli.cat * Corresponding author: 1 Page 1 of 7 Narcís Cardoner. Address: OSAMCAT. Santa Fe Building, 2on floor. Parc del Taulí, 1 - 08208 Sabadell (Barcelona). Spain. E-mail: ncardoner@tauli.cat Telephone number: +34 93 724 01 82 Fax number: +34 93 717 50 67 Acknowledgments: The authors thank Miguel Angel Ruiz Dominguez for his contribution to the cost-benefit analysis, and all of the study subjects as well as the of staff from the Department of Mental Health of Parc Taulí Unversity Hospital. ro -p Conflict of interest: The authors state they have no conflicts of interest to declare. re Role of funding sources: This research did not receive any specific grant from lP funding agencies in the public, commercial, or not-for-profit sectors. na ur Jo Dear Editor, The COVID-19 pandemic has raised serious concerns in all healthcare systems. Due to this exceptional situation, many aspects of regular medical practice have had to be reconsidered. Unfortunately, ECT and other medical services, labeled as "non-urgent" or "non-essential" and have been delayed.1,2 Maintenance ECT (M-ECT) has been 2 Page 2 of 7 particularly affected: the time between treatments has been prolonged1 or fully discontinued in many hospitals.3–7 Literature on the outcome of patients discontinuing M-ECT is limited, but the data suggest high rates of relapse (44-50%), especially in the first year after discontinuation.8,9 In our hospital, ECT was halted completely on March 18, 2020, mainly due to the reassignment of anesthesiologists to the intensive care units. Normal activity was not resumed until May 8, 2020. At the time of cessation of ECT, 37 patients were on the ECT program, 33 of them receiving M-ECT. Our real-world prospective study aims to of characterize the clinical outcome of these patients, from the time of the interruption of M-ECT until January 15, 2021, and to analyze the related cost-benefit ratio. ro Demographic, clinical and M-ECT data were recorded. A relapse was defined as the -p need for hospital admission, or the need for a new acute ECT course; M-ECT was also reestablished in the case of early signs of relapse. The study was approved by the re Hospital Ethics Committee. lP Descriptive and survival analysis were performed (a Kaplan-Meier to estimate the time until full clinical relapse or the occurrence of early signs of decompensation, and a univariate Cox analysis to identify potentially contributing factors). Variables that na displayed significant associations were entered into a multivariate Cox regression model. A cost estimate was made, determining the economic "savings" in M-ECT ur sessions during the period in which ECT was not applied, the "saved sessions" in Jo patients who to date have not restarted M-ECT as well as the cost in days of admission and the number of additional ECT sessions. Nineteen of the 33 patients (57.6%) were female (with a mean age of 67.12 years (±12.1; 40-85)). Sixteen patients (48.5%) met criteria for major depressive disorder. The mean number of previous episodes in the last five years was 3.52 (±3.2). The mean duration of M-ECT was 41.78 months (±52.4; 1.45-273.1). Twenty-six patients (78.8%) were receiving M-ECT at a monthly frequency or higher at the time of 3 Page 3 of 7 treatment discontinuation. One of the patients on the M-ECT program died of COVID- 19 in March 2020. When the ECT program was resumed a risk-benefit analysis was made, prioritizing acute ECT. Regarding the clinical course of the 32 patients, 19 (59.4%) met criteria for relapse (eight patients (25%) need for hospital admission or a new acute ECT course) or experienced early signs of relapse and M-ECT was reestablished (11 patients, 34.4%). The mean time to relapse or the emergence of early signs of relapse was 88.84 days (±78.8; 61 median, 15-290). Furthermore, two patients preferred to restart of M-ECT despite having no relapse symptoms. Finally, to date, 11 patients (34.4%) have opted not to restart M-ECT while awaiting the evolution of the pandemic, and are ro clinically stable. As of January 15, 2021, 62.5% of patients (20/32) had resumed M- ECT. -p Seventeen of the 19 patients (89.47%) who relapsed or showed early signs of re relapse did so in the first six months. In the univariate Cox analysis, patients with an lP interval between sessions at the time of discontinuation of less than one month showed a higher risk of clinical decompensation (HR, 7.43; 95% CI, 2.60-21.19; p = 0.000). The number of previous episodes in the last five years also influenced clinical na decompensation (HR, 3.81; 95% CI, 1.41-10.27; p = 0.008). Other variables (age, sex, diagnosis, duration of M-ECT) did not appear to influence clinical decompensation. In ur the multivariate Cox regression model, only the interval between sessions at time of Jo discontinuation emerged as a predictor of clinical decompensation. The cost of M-ECT session is estimated at 197.15 euros. During the period when M- ECT was not available, it was estimated that 80 M-ECT sessions were not held, with a "saving" of 15772 euros. In patients in whom M-ECT was not resumed, when ECT was available once again, 16 sessions were not performed, with a "saving" of 3154.4 euros. Furthermore, 11 patients have not restarted M-ECT to date, with an additional "saving" of 73 sessions (14391.95 euros). The cost of admissions and acute ECT courses was 4 Page 4 of 7 63594.61 euros. Thus, the discontinuation of the M-ECT program resulted in an additional cost of 30276.26 euros. The COVID-19 pandemic health crisis led to the complete cancellation of the M-ECT program. More than half of the patients on this program have since relapsed or developed early signs of relapse, and required admission to an acute hospitalization unit, the initiation of an acute ECT course, or re-inclusion on the M-ECT program. Negative clinical outcomes significantly affected patients who received M-ECT more frequently, i.e., with an interval between sessions of less than one month. In fact, all of stabilized patients were receiving M-ECT at a frequency higher than a month. The results of this and previous studies indicate the high risk of relapse in patients ro discontinuing M-ECT.8,9 Likewise, the discontinuation of the M-ECT program increased -p economic costs, deriving from the need for hospitalization and for new acute courses of ECT. The results highlight the importance of this treatment and therefore M-ECT must re be taken into account in future contingency plans. If M-ECT delivery is impossible, a close monitoring protocol should be established with the capability for conducting lP rescue sessions.3 It is also very important to intensify communication between patients, families and therapists in order to maximize early detection of relapse.7 Finally, whether na or not we are able to develop prioritization criteria, each case must be approached on an individual basis. ur The inability to maintain ECT programs may significantly increase the risk of Jo relapse, the rates of hospitalization, and also incurs high healthcare costs. Healthcare managers and providers should be reminded that ECT is an essential treatment. If access to ECT cannot be guaranteed in all settings, centralized care should be considered. REFERENCES 1. Espinoza RT, Kellner CH, McCall W V. Electroconvulsive Therapy During 5 Page 5 of 7 COVID-19: An Essential Medical Procedure-Maintaining Service Viability and Accessibility. J ECT. 2020;36:78-9. doi:10.1097/YCT.0000000000000689 2. Tor P-C, Tan J, Loo C. A Model for ethical triaging of electroconvulsive therapy patients during COVID-19 pandemic. BJPsych Bull. August 2020:1-13. doi:10.1192/bjb.2020.99 3. Sienaert P, Lambrichts S, Popleu L, Van Gerven E, Buggenhout S, Bouckaert F. Electroconvulsive Therapy During COVID-19-Times: Our Patients Cannot Wait. Am J Geriatr Psychiatry. 2020;28:772-5. doi:10.1016/j.jagp.2020.04.013 of 4. Gil-Badenes J, Valero R, Valentí M, Macau E, Bertran MJ, Claver G, et al. Electroconvulsive therapy protocol adaptation during the COVID-19 pandemic. ro J Affect Disord. 2020;276:241-8. doi:10.1016/j.jad.2020.06.051 5. Lapid MI, Seiner S, Heintz H, Hermida AP, Nykamp L, Sanghani SN, et al. -p Electroconvulsive Therapy Practice Changes in Older Individuals Due to re COVID-19: Expert Consensus Statement. Am J Geriatr Psychiatry. 2020;28:1133-45. doi:10.1016/j.jagp.2020.08.001 lP 6. Tor PC, Phu AHH, Koh DSH, Mok YM. Electroconvulsive Therapy in a Time of Coronavirus Disease. J ECT. 2020;36:80-5. na doi:10.1097/YCT.0000000000000690 7. Sagué-Vilavella M, Gil-Badenes J, Baldaquí Baeza N, Gómez SM, Pacchiarotti ur I, Cabrera MTP, et al. The Other Victims of COVID-19: The Value of Electroconvulsive Therapy. J ECT. 2021;37:e1-e2. Jo doi:10.1097/YCT.0000000000000718 8. Huuhka K, Viikki M, Tammentie T, Tuohimaa K, Björkqvist M, Alanen HM, et al. One-year follow-up after discontinuing maintenance electroconvulsive therapy. J ECT. 2012;28:225-8. doi:10.1097/YCT.0b013e3182548f93 9. Martínez-Amorós E, Serra P, Goldberg X, Urraca L, Palao DJ, Urretavizcaya M, et al. Clinical outcome after discontinuation of maintenance Electroconvulsive Therapy. A retrospective follow-up study. Rev Psiquiatr Salud Ment. 2020;13:5- 6 Page 6 of 7 10. doi:10.1016/j.rpsm.2019.07.001 of ro -p re lP na ur Jo 7 Page 7 of 7