Background: Due to abnormal valve geometry, patients with bicuspid aortic valve (BAV) have been excluded in many transcatheter aortic valve replacement (TAVR) trials resulting in very limited data with regards to its safety and efficacy. Methods: We searched electronic databases including Cochrane Database of Systematic Reviews, MEDLINE and EMBASE for all studies including case series, and original reports published before December 2018 that assessed outcomes following TAVR in BAV stenosis. We also included studies that had patients with TAV for comparison. Pooled effect size was calculated with a random-effect model and weighted for the inverse of variance, to compare outcomes post-TAVR between BAV and TAV. The heterogeneity of effect estimates across the studies was assessed using I2. Publication bias was assessed with funnel plots. Statistical analysis was performed using SPSS version 24 (IBM Corp., SPSS Statistics for Windows, Version 24.0. Armonk, NY.) Results: A total of 19 studies describing 1,332 patients with BAV and 3,610 with TAV. There was no significant difference in the30-day mortality between patients with BAV and TAV [odds ratio (OR): 1.18, 95% confidence interval (CI): 0.7-1.7, P=0.41, I 2 =0]. One-year mortality rate in the BAV population was 13.1% compared to 15.4% in the TAV patients (P=0.75). Patients with BAV had significantly more moderate to severe paravalvular leak (PVL) post TAVR (PVL ≥3) 8.8% vs. 4.2% in TAV patients (OR: 1.478, 95% CI: 1.000-2.184, P=0.050, I 2 =0. Device success was significantly higher in TAV patients compared to BAV patients 93.5% vs. 87% (OR: 0.63, 95% CI: 0.49-0.86, P=0.003). Conclusions: TAVR in patients with BAV is associated with a high incidence of paravalvular regurgitation with a comparable 30-day mortality rate to TAV patients. The use of newer generation valve prosthesis improved outcomes.
Background: Pre-existing chronic kidney disease (CKD) portends adverse outcomes following heart valve surgery. However, only limited and conflicting evidence is available on the impact of CKD on outcomes following transcatheter aortic valve replacement (TAVR). The objective of this review was to evaluate the effect of pre-existing CKD on TAVR outcomes.Methods: We performed a systematic electronic search using the PRISMA statement to identify all randomized controlled trials and observational studies investigating the effect of pre-existing CKD on outcomes following TAVR. 30-day and long-term outcomes were measured comparing patients with Glomerular filtration rate (GFR) ≥60 to those with GFR <60.Results: Ten studies were analyzed comprising of 8688 patients. Compared to patients with GFR ≥60, those with GFR < 60 had worse 30-day all cause mortality (OR 1.40, 95% CI: 1.13-1.73), cardiovascular mortality (OR 1.66, 95% CI: 1.04-2.67), strokes (OR 1.39, 95% CI: 1.05-1.85), acute kidney injury (OR 1.42, 95% CI: 1.21-1.66) and the risk for dialysis (OR 2.13, 95% CI: 1.07-4.22). There was no difference in device success (p=0.873), major or life threatening bleeds (p = 0.302), major vascular complications (p=0.525), need for pacemaker implantation (p = 0.393) or paravalvular leaks (p = 0.630). All-cause mortality at 1 year was also significantly higher in patients with GFR <60 (OR 1.80, 95% CI: 1.26-2.56).Conclusion: Pre-existing CKD defined as GFR <60 is a strong predictor of worse short and long-term outcomes following TAVR. Active measures should be taken to mitigate the postprocedure risk in these group of patients.
For patients with atrial fibrillation (AF) and acute coronary syndrome (ACS), it is often challenging to find the optimal balance between the risk for ischemic and hemorrhagic complication when using both antiplatelet therapy and oral anticoagulation (OAC) with vitamin K antagonist (VKA) or direct oral anticoagulants (DOACs). Current guidelines recommended: (I) double therapy with a P2Y12 inhibitor and dose adjusted VKA is reasonable post-stenting; (II) double therapy with clopidogrel and low-dose rivaroxaban (15 mg daily) may be reasonable post-stenting; (III) double therapy with a P2Y12 inhibitor and dabigatran 150 mg twice daily is reasonable post-stenting. In the AUGUSTUS trial, most patients were given clopidogrel as part a DAPT regimen, however prasugrel and ticagrelor use allowed albeit in a small percentage of the trial population, underestimating its effect. Ticagrelor and prasugrel are known to have a stronger antiplatelet effect compared to clopidogrel, however randomized studies have not been adequately powered to date allowing comparisons between ticagrelor, prasugrel and clopidogrel together in the setting of anticoagulation for the treatment of patients with ACS and AF. Careful consideration should be given to this scenario to avoid falling into the concept of sacrificing efficacy for safety.
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