Does valve in valve TAVR carry a higher risk for thromboembolic events compared to native valve TAVR?

OBJECTIVE: To evaluate the risk for brain lesions in valve in valve (VIV)-transcatheter aortic valve replacement (TAVR) compared to native valve procedures (NV-TAVR). BACKGROUND: TAVR is associated with the risk of stroke and a high incidence of brain lesions in diffusion-weighted magnetic resonance imaging (DW-MRI). The risk in VIV procedures is unknown. METHODS: Patients were included, if they received a Sapien-3 or an Evolut-R valve for an NV-TAVR or VIV-TAVR and a DW-MRI within 3-5 days after the procedure. RESULTS: Two hundred nine patients had NV-TAVR and 41 patients had VIV-TAVR. The VIV group was significantly younger (mean 82.3 vs. 74.7 years old, p < .001) but had higher mean EuroSCORE II (4.8 vs. 7.8, p < .001). Predilatation was significantly more common with native valve (39% vs. 2%, p < .01), postdilatation rate was lower in VIV but without statistical significance (17% vs. 7%, p = .110). Combined in-hospital safety outcome was comparable [13(6.6%) vs. 5(12.2%), p = .205]. Any stroke was documented in four (0.5%) patients after native valve and in one (2.4%) after VIV-TAVR. New DW-MRI brain lesions were significantly more often found in patients with native valves [153(73.2%) vs. 21(51.2%), p = .005], mean number of new lesions was also higher with native valve (2.8 ± 3.2 vs. 1.0 ± 1.4, p < .001). Forward stepwise of logistic regression found age and post dilatation significant predictors of new MRI lesions. CONCLUSIONS: Compared to native valves, VIV procedures were associated with lower incidence and number of brain lesions according to DW-MRI; these were explained by lower patients' age and lower rate of postdilatation.

Performance of the Evolut-R 34 mm versus Sapien-3 29 mm in Transcatheter aortic valve replacement patients with larger annuli: Early outcome results of Evolut-R 34 mm as compared with Sapien-3 29 mm in patients with Annuli ≥26 mm.

BACKGROUND: Evolut-R 34 mm (received CE mark in January 2017) and Sapien-3 29 mm are the only options for transcatheter aortic valve replacement (TAVR) in patients with annulus ≥26 mm. We compared the short-term outcomes of these valves in these patients. METHODS: Data was collected prospectively from consecutive patients with severe aortic stenosis and annulus diameter larger than 26 mm treated by femoral approach TAVR. RESULTS: Between February 1, 2014 to August 19, 2017 Sapien-3 29 mm was implanted in 55 and Evolut-R 34 mm in 37 consecutive patients. Device success rate was 98.2% and 97.3% (P = 1.0) and the composite peri-procedural complication rate was 7.3% and 2.7% (P = .645) in Sapin-3 29 mm and Evolut-R 34 mm, respectively. Composite endpoint of early safety in-hospital did not differ significantly [5(9.2%) vs 3(8.1%), P = 1.00], respectively. Prosthetic valve Gradients were significantly lower with Evolut-R 34 mm [maximal (18.0 ± 5.8 vs 11.2 ± 4.8 mmHg, P < .001) and mean (10.0 ± 3.3 vs 6.3 ± 2.7 mmHg, P < .001)]. Pacemaker implantation rate was high in both groups, and numerically but not statistically significant higher with Evolut-R [10/50 (20.0%) vs 8/28 (28.6%), P = .389]. CONCLUSIONS: As compared to Sapien-3 29 mm the Evolut-R 34 mm is a real alternative for TAVR in patients with a large annulus with a comparable peri-procedural complication rate, better hemodynamic results but a trend for higher pacemaker rate.

Increased Risk of Cerebral Embolization After Implantation of a Balloon-Expandable Aortic Valve Without Prior Balloon Valvuloplasty.

OBJECTIVES: The purpose of this study was to analyze the effect of transcatheter aortic valve replacement (TAVR) without versus with prior balloon aortic valvuloplasty (BAV) on the risk of cerebral embolization in patients who receive a balloon-expandable valve. BACKGROUND: Avoiding BAV prior to TAVR may simplify the procedure, but the risk of cerebral embolization is currently unknown. METHODS: A total of 87 consecutive high surgical-risk patients with no contraindications for diffusion-weighted magnetic resonance imaging (DW-MRI) were enrolled. Thirty-two patients received a balloon-expandable aortic valve with and 55 patients without BAV. The incidence, number, and volume of new ischemic lesions in DW-MRI performed 2 to 7 days after TAVI were evaluated. RESULTS: Mean age (83.8 ± 5.2 years vs. 82.9 ± 6.8 years) and sex (43.8% vs. 52.7% male) of the patients with versus without BAV, respectively, as well as other demographic and hemodynamic data were not significantly different between both groups. The procedural success rate was 93.5% with and 98.2% without BAV, and procedure duration and contrast volume were significantly lower without BAV. The incidence of new cerebral ischemic lesions in the total cohort was 66.7%. Compared with patients with BAV, those without BAV had a significantly higher total volume of cerebral ischemic lesions (235.4 ± 331.4 mm(3) vs. 89.5 ± 128.2 mm(3); p = 0.01). CONCLUSIONS: The implantation of a balloon-expandable aortic valve without versus with prior BAV, although performed with a shorter procedure time and lower contrast volume, is associated with a significantly higher volume of cerebral ischemic lesions.