Interventional procedure overview of aortic valve reconstruction using glutaraldehyde-treated autologous pericardium for aortic valve disease

Population and studies description

This interventional procedures overview is based on more than 30,000 patients from 1 meta-analysis (Mylonas 2023), 1 case series and meta-analysis (Benedetto 2021), 1 systematic review (Dilawar 2022), 1 case series (Halees 2005), 1 multicentre case series (Sá 2020), 1 non-randomised comparative study (Boehm 2022) and 2 case reports (Mikami 2022; Bernhardt 2021). Of these patients, about 5,000 patients had the procedure. There was some overlap in patients between studies and overlap in papers between systematic reviews and meta-analysis. Some of the studies summarised separately were also included in at least 1 of the reviews. The case series and meta-analysis by Benedetto et al. (2021) was included in the meta-analysis by Mylonas et al. (2023).

This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 8 studies as the key evidence in table 2 and table 3, and lists 44 other relevant studies in table 5.

Of the 22 studies included in the meta-analysis by Mylonas et al. (2023), there were 15 cases series, 3 retrospective cohort studies, 1 prospective propensity score matching (PSM) cohort study, 1 prospective cohort study, 1 retrospective PSM cohort study and 1 case series and meta-analysis. The quality of included case series was assessed using the National Heart, Lung, and Blood Institute scale. The Newcastle-Ottawa Quality scale was used to evaluate the quality of case-control studies, with a score of at least 6 indicating high quality. In the item assessing whether the follow-up period was long enough for outcomes to occur, the cut-off value was set at 12 postoperative months per study, and a rate of 90% was used to define adequate follow up. All 7 of the studies for aortic valve neocuspidisation (AVNeo) included in Benedetto et al. (2021) were retrospective. Risk of bias in individual studies was assessed using the quality in prognostic studies instrument as per published protocol. Of the 12 studies included in Dilawar et al. (2022), all were retrospective single-centre series, 1 of which was a comparative study. The risk of bias of each study was measured using Methodological Index for Non-Randomized Studies (MINORS). The global ideal score was 16 and 24 for non-comparative and comparative studies, respectively.

Recruitment periods of the key evidence studies began in 1988 (Halees 2005). Follow-up periods, when reported, ranged from 12.5±0.9 months to 16 years.

The studies included in the meta-analysis and systematic review were done in various locations, including several countries in Europe, the US, China, and Japan, India and Vietnam. The other key evidence studies were done in the UK, Brazil, Russia, Germany, Saudi Arabia, Japan, Vietnam, and the US.

All studies included patients who had aortic valve reconstruction with glutaraldehyde-treated autologous pericardium. In the meta-analysis by Mylonas et al. (2023), the mean age was stratified to adult patients (65±12.3 years) and paediatric patients (12.3±3.8 years). Table 2 presents study details.