Because the real benefit of pulmonary valve replacement (PVR) in patients with repaired tetralogy of Fallot who develop pulmonary insufficiency remains unclear, it is necessary to analyze the evidence published around the world. We performed a systematic review of studies that reported data about the effect of PVR in patients with repaired tetralogy of Fallot that developed pulmonary insufficiency, until December 2012. The variables chosen to represent the benefit were both right ventricular (RV) and left ventricular measures, QRS duration, and functional class. The principal summary measures were difference in means with 95% confidence interval and p values (considered statistically significant when p < 0.05). The differences in means were combined across studies with the weighted DerSimonian-Laird random effects model. Meta-analysis, sensitivity analysis, and meta-regression were completed with the software Comprehensive Meta-Analysis (version 2, Biostat, Inc., Englewood, New Jersey). Forty-eight studies involving 3,118 patients met the eligibility criteria. The pooled 30-day mortality was 0.87% (47 studies; 27 of 3,100 patients); the pooled 5-year mortality was 2.2% (24 studies; 49 of 2,231 patients); the pooled 5-year re-PVR was 4.9% (15 studies; 88 of 1,798 patients). The results of this meta-analysis demonstrate that after PVR: 1) the RV experiences improvement of its volumes and function; 2) the left ventricle experiences improvement of its function; 3) QRS duration decreases; 4) symptoms improve; 5) pre-operative RV geometry modulates the effect of PVR; and 6) there is important heterogeneity of the effects among the studies, and few publication biases. In conclusion, PVR seems to be a positive approach in the analyzed scenario.
Background
There is a rising trend for transcatheter aortic valve implantation (TAVI) in bicuspid aortic stenosis patients. Data on the use of self‐expandable (SEV) vs. balloon‐expandable (BEV) valves in these patients are scarce. Therefore, we systematically compared clinical outcomes in bicuspid aortic stenosis patients treated with SEV and BEV.
Methods
Data were extracted from PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, http://clinicaltrials.gov, SciELO, LILACS, Google Scholar and reference lists of relevant articles. Eight studies published from 2013 to 2020 including a total of 1,080 patients (BEV: n = 620; SEV: n = 460) were selected. Primary endpoints were procedural, 30‐day and 1‐year mortality. Secondary endpoints were new pacemaker implantation, annular rupture, coronary obstruction, moderate‐to‐severe paravalvular leak, need of second valve, stroke and acute kidney injury.
Results
We found no statistically significant difference in mortality between patients treated with BEV vs. SEV during index procedure, at 30 days and at 1 year. BEVs showed a statistically significant higher risk of annulus rupture (2.5%) in comparison with SEV (0%) (OR 5.81 [95% CI, 3.78–8.92], p < .001). New generation BEVs were also associated with significantly less paravalvular leak when compared to new generation SEVs (OR 0.08 [95% CI, 0.02–0.35], p = .001).
Conclusions
This meta‐analysis of observational studies of TAVI for bicuspid valves, showed no difference in short‐ and mid‐term TAVI mortality with BEVs and SEVs. BEVs presented a higher risk of annular rupture in comparison with SEV.
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