TAVI achieved 95% technical success but had 11% all-cause mortality at 8 months, with AKI, valve dysfunction, PPM, and high calcification predicting worse outcomes.
What is the incidence and what are the predictors of complications after TAVI according to the VARC-3 criteria?
TAVI demonstrates high technical success (95%) according to VARC-3 criteria, though complications such as major bleeding, permanent pacemaker implantation, and AKI remain relevant and are linked to higher mortality.
Absolute Event Rate: 0% vs 0%
Abstract Background Despite continuous advancements in devices and procedural techniques, Transcatheter Aortic Valve Implantation (TAVI) is still associated with a range of complications that may significantly affect outcomes. The Valve Academic Research Consortium recently renewed the classification of TAVI procedural complications introducing the VARC-3 criteria. However, only few data are currently available on TAVI complications applying this new classification. Aim The aim of our study was to assess the incidence of main TAVI complications, classified according to the most recent VARC-3 criteria. Furthermore, we evaluated the main predictors of complications available in literature and performed a pooled analysis of the significant ones. Methods We conducted a systematic literature review and meta-analysis including 60 eligible studies reporting data on complications after TAVI according to VARC-3 criteria. The primary endpoint was the incidence of technical success according to VARC-3 and all-cause mortality, whereas the major complications defined according to VARC-3 criteria were the secondary ones. We further analyzed pooled OR to identify the key predictors of major complications after TAVI Results A total of 60 studies encompassing 75,014 patients was included in the analysis. The average age of our cohort was 81,7 yo, 51,7% were women, mean ejection fraction was 55,5%, mean aortic gradient was 43 mmHg and the overall surgical risk profile was low-to-moderate (STS PROM 4,1%). There was a slight prevalence of balloon expandable valve (BEV) implantations (52,2%). In our cohort technical success was achieved in 95% of cases, with a 66% 30-days early safety and 90% device success. On average 8 months follow-up (IQR 1-21) all-cause mortality occurred in 11% cases, with periprocedural death representing 3%. Overall vascular complications incidence was 13%, 5% of which was represented by major events. Stroke or TIA occurred in 3%, as well as Acute Kidney Injury (AKI). Incidence of major bleedings (type 2 and beyond) was 10%, permanent PM implantation was reported in 13% of cases. Significant paravalvular regurgitation (PVR) was reported in 4% of cases while moderate to severe patient prosthetic mismatch (PPM) occurred in 8%. Stage 3 or 4 AKI, significant PVR, bleeding type ≥2, non-structural valve dysfunction and STS score resulted independent predictors of all-cause mortality, whereas high aortic valve calcification and eccentric calcium were predictors of significant PVR. At meta regression analysis moderate-to-severe PPM was associated with high mortality. Conclusions TAVI shows high technical success and early safety, but significant complications remain relevant. High aortic valve calcification and eccentric calcium predicted paravalvular regurgitation, while AKI, non-structural valve dysfunction, and PPM were linked to higher mortality.Pooled all-cause mortality incidence
Giacobbe et al. (Sat,) reported a other. TAVI achieved 95% technical success but had 11% all-cause mortality at 8 months, with AKI, valve dysfunction, PPM, and high calcification predicting worse outcomes.