Complications after Surgical Procedures in Patients with Cardiac Implantable Electronic Devices: Results of a Prospective Registry

Abstract

Background:Complications after surgical procedures in patients with cardiac implantable electronic devices (CIED) are an emerging problem due to an increasing number of such procedures and aging of the population, which consequently increases the frequency of comorbidities.Objective:To identify the rates of postoperative complications, mortality, and hospital readmissions, and evaluate the risk factors for the occurrence of these events.Methods: Prospective and unicentric study that included all individuals undergoing CIED surgical procedures from February to August 2011. The patients were distributed by type of procedure into the following groups: initial implantations (cohort 1), generator exchange (cohort 2), and lead-related procedures (cohort 3). The outcomes were evaluated by an independent committee. Univariate and multivariate analyses assessed the risk factors, and the Kaplan-Meier method was used for survival analysis.Results: A total of 713 patients were included in the study and distributed as follows: 333 in cohort 1, 304 in cohort 2, and 76 in cohort 3. Postoperative complications were detected in 7.5%, 1.6%, and 11.8% of the patients in cohorts 1, 2, and 3, respectively (p = 0.014). During a 6-month follow-up, there were 58 (8.1%) deaths and 75 (10.5%) hospital readmissions. Predictors of hospital readmission included the use of implantable cardioverter-defibrillators (odds ratio [OR] = 4.2), functional class III­-IV (OR = 1.8), and warfarin administration (OR = 1.9). Predictors of mortality included age over 80 years (OR = 2.4), ventricular dysfunction (OR = 2.2), functional class III-IV (OR = 3.3), and warfarin administration (OR = 2.3).Conclusions: Postoperative complications, hospital readmissions, and deaths occurred frequently and were strongly related to the type of procedure performed, type of CIED, and severity of the patient's underlying heart disease.

Transvenous revision of leads with cardiac perforation following device implantation—Safety, outcome, and complications

“…7 Major device-related complications result in prolonged hospitalization and increased costs and are associated with worse outcomes and increased mortality. 8 In general, perforated leads have to be revised to relieve the patient's symptoms and restore device function, and limited data on feasibility and outcomes of both surgical and percutaneous revisions have been reported previously. 5,9 Transvenous extraction of perforated leads with subsequent reimplantation of a new lead is less invasive compared to the surgical approach and therefore may represent a considerable treatment option, but data on complication rates and outcome of patients undergoing this intervention are scarce.…”

“…The frequency of pericardial effusion requiring pericardiocentesis has been described with up to 0.5% 7 . Major device‐related complications result in prolonged hospitalization and increased costs and are associated with worse outcomes and increased mortality 8 . In general, perforated leads have to be revised to relieve the patient's symptoms and restore device function, and limited data on feasibility and outcomes of both surgical and percutaneous revisions have been reported previously 5,9 .…”

Terapia de ressincronização cardíaca nas cardiomiopatias chagásica e não chagásicas

“…Ocorreram 16 complicações cirúrgicas em 16 pacientes diferentes (16,3%), incluindo complicações maiores e menores, como classificado em grande estudo na Dinamarca (Kirkfeldt et al, 2014), entretanto nesse estudo citado, a maioria dos pacientes arrolados haviam sido submetidos a procedimentos de marcapasso convencional que apresenta menor risco cirúrgico. Silva e col. (Silva et al, 2016) mostrou taxa total de complicações, também classificadas como maiores e menores, de 28,6%. Se por um lado estavam inclusas taxas de complicações de todos os procedimentos relacionados a dispositivos eletrônicos implantáveis desde baixo até alto risco, por outro lado foram avaliados todos aqueles ocorridos em até 6 meses do implante, portanto complicações tardias não contempladas nesse coorte.…”

“…A taxa de óbito hospitalar foi 5,1%. O valor é superior àqueles de algumas séries (Kirkfeldt et al, 2014;Silva et al, 2016), mas a forma de classificar a mortalidade também foi diferente. Os estudos citados consideraram as mortalidades somente durante a internação hospitalar ou desde o procedimento até um período fixo de 3, 6 ou 9 meses após procedimento.…”

“…A idade também tem valor p=0,052 muito próximo dos 5% e provavelmente seria preditor se o número da amostra fosse maior. Em estudos de avaliação específica de complicações relacionadas aos procedimentos com dispositivos eletrônicos, a idade também foi preditor de mortalidade (Kirkfeldt et al, 2014;Silva et al, 2016) A melhora da FEVE após a ressincronização é fator de diminuição de chance de mortalidade (OR=0,904 IC=95%, 0,845-0,966).…”