Safety outcomes of new versus old generation transcatheter aortic valves

Abstract

Objective To compare procedural outcomes of transcatheter aortic valve implantation (TAVI) patients who were implanted with older versus newer generation valves. Background The current evidence base for improved safety of the newer commercially available TAVI valves is limited. Methods A retrospective analysis of the Israeli multicenter TAVI registry was performed. Patients were stratified by valve generation of four commercially available devices: Edwards Sapien (ESX) Edwards Sapien S3 (ES3), Medtronic CoreValve (MCV), and Medtronic Evolut R (MER). Results The cohort consisted of 737 patients with new generation valves (NGVs; ES3 n = 223; MER n = 514) and 1,869 with old generation valves (OGVs; MCV n = 1,181; ESX n = 688). Device success rates were significantly higher in NGV (97.5 versus 95.4%), with less post‐procedural paravalvular leak (3 versus 5.8%), and valve mal‐positioning (1.2 versus 3.4%); all P‐values<0.05. There were no differences in rates of permanent pacemaker implantation, stroke or acute kidney injury (AKI) of any stage between the groups, although stage ≥2 AKI was more prevalent in NGV. After adjustment to significant differences in baseline patient and procedural characteristics, device success was higher (OR 1.86, 95% confidence interval (CI) 1.09–3.18, P = 0.023) and the 1‐month safety outcome was significantly lower (OR 0.72, 95% CI 0.55–0.96, P = 0.025) for NGV. Device success was driven mainly by improved rates of PVL of ES3, while the safety outcome was mainly driven by improved rates of life‐threatening bleeding and valve mal‐positioning of MER. Conclusion As compared to OGV, use of NGV for TAVI was associated with higher rates of device success and lower rates of adverse events.

Prognostic implication of right ventricular dysfunction and tricuspid regurgitation following transcatheter aortic valve replacement

“…A similar finding was noted also for patients with ≥moderate TR at baseline with improved TR at 1 month, with a HR of 1.34 (1.0–1.78). Our findings support previous studies suggesting that TR grade is a surrogate marker for other comorbidities and systolic or diastolic dysfunction 14‐20 . The question whether tricuspid valve intervention in patients with ≥moderate TR at baseline without improvement at 1 month would improve clinical outcome remains un‐answered.…”

“…The present cohort included patients enrolled to the Israeli multicenter TAVR registry comprised of four tertiary university–affiliated medical centers between September 2008 and June 2019 15‐17 . The study was approved by the institutional review board at each participating center.…”

Point-of-Care Ultrasound Before and After Transfemoral Transcatheter Aortic Valve Implantation

“…PVLs are one of the most commonly reported complications after a TAVI procedure ( 18 , 19 ). However, with more experience, optimal annular sizing methods and evolution of the new generation of TAVI valves, the incidence of a major PVL has been declining ( 20 , 21 ). Considering these factors, we used TTE to evaluate PVLs of haemodynamic significance.…”

Transcatheter Aortic Valve Replacement Optimization Strategies: Cusp Overlap, Commissural Alignment, Sizing, and Positioning

“…10 While the incidence of PVL was observed to be higher in early generation valves, the rate has improved with the availability of a wider range of valve sizes and with the development of newer generation valves that have been engineered to provide better sealing mechanisms. 11 The PARTNER 3 trial reported similar rates of moderate to severe PVL with the BEVs compared to SAVR (0.6% versus 0.5%). 12 However, the incidence of moderate to severe PVL was reported to be higher with SEVs as seen in the Medtronic low-risk study (3.5% versus 0.55%).…”