Epicardial closure of left atrial appendage using clips in atrial fibrillation assessed by Spanish AETSA

In February 2020, the Andalusian Health Technology Assessment Department (AETSA) published an assessment report on the evaluation of effectiveness and safety of epicardial closure of left atrial appendage using clips by minimally invasive surgery for thromboembolism prevention in patients with atrial fibrillation in Spain.

The systematic review of the scientific literature was performed; original articles without limitation due to study design with sample size equal to or greater than 10 cases were included. Editorials, abstracts, congress communications, and letters were excluded. The evaluation of the quality of the randomized controlled trials has been carried out with the Cochrane Collaboration tool for the assessment of the risk of bias, and the level of evidence was evaluated with the GRADE tool. The quality of cases series was assessed with the tool designed by the Institute of Health Economics of Canada. Two researchers simultaneously performed the selection, extraction, and quality assessment of the information. The gathered information was summarized through a narrative synthesis with results tabulation but not performing meta-analysis because of the heterogeneity of the information. GRADE, together with the case-series quality assessment tool of the IHE (Institute for Health Economics of Canada), was used for evidence analysis.

The following results were outlined by AETSA:

• Six non-comparative observational studies (case series) that met the inclusion criteria were selected; they contained 351 patients. All of them were operated using the minimally invasive approach, performing thoracoscopy in 89.5% of the cases, mini-thoracotomy in 7.4%, and unspecified technique of minimally invasive surgery in 3.1%. The left atrial appendage clipping was usually done as a secondary intervention, making ablation during the same surgical intervention for atrial fibrillation treatment (concomitant intervention). Only in 10.2% of the cases clipping was done as an isolated intervention
• The six included studies evaluated the model Atriclip PROTM, but none of the studies reported results of the implementation of the Atriclip PRO2TM model:
  • Regarding successful implantation of the device, this happened in 99.1% of the concomitant and 94.1% of the isolated interventions. The significant residue in 6.8% of 251 concomitant interventions was observed after 3 to 6 months of follow-up. For isolated interventions, this was only measured on 10 patients, and it was 20%
  • Regarding thrombo-embolism prevention, the longer follow-up (median follow-up of 20 months) was done over 222 patients. In this study, two cases were reported, which meant a rate of 0.5 events/100 patients-year. No deaths related to the intervention were reported
  • Regarding safety, few intra-operative complications directly related to the intervention (only one case of device displacement) were reported
  • As for adverse events after follow-up, few cases of complications after 30 days monitoring of 222 patients were reported (three cases of pleural effusion, a case of empyema, hemithorax, hemodynamic instability, and respiratory infection).

The following conclusions were provided by AETSA:

• The scientific evidence about the effectiveness and safety of the left atrial appendage closure through minimally invasive epicardial clipping is inadequate and insufficient as it is composed exclusively of six non-comparative studies (case series)
• There were few peri-operative complications related to the intervention. Few adverse events with follow-up were reported
• It is impossible to determine the effectiveness and safety of the procedure in comparison with other interventions used for thromboembolism prevention in patients with atrial fibrillation who are not candidates for oral anticoagulants
• Well-designed studies that compare with sufficient follow-up, the results of the implementation of this intervention with respect to its alternatives are needed.

See the full health technology assessment report in Spanish here.

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