scholarly journals Short-Term outcomes using contemporary balloon-expandable valves in transcatheter aortic valve implantation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G Medranda ◽  
R K Schwartz ◽  
S J Green

Abstract Background/Introduction Advancements in balloon-expandable transcatheter heart valves (THV) have improved outcomes in transcatheter aortic valve implantation (TAVI). The most recent iteration, the SAPIEN 3 Ultra THV, offers a taller paravalvular skirt which has demonstrated similar short-term outcomes while reducing mild paravalvular leak in high- and intermediate-risk patients. Purpose We sought to describe a real-world experience comparing short-term outcomes in the SAPIEN 3 THV to the SAPIEN 3 Ultra THV in patients across the risk spectrum (including low-risk). Methods We conducted a retrospective, observational study of patients who underwent TAVI using either the SAPIEN 3 or SAPIEN 3 Ultra THV between 2019–2020. In-hospital, 30-day and 1-year Valve Academic Research Consortium-2–defined outcomes were examined. Results We screened a total of 457 patients who underwent TAVI at our institution between 2019–2020. Included were 254 patients who received either the SAPIEN 3 THV or the SAPIEN 3 Ultra THV. Baseline clinical characteristics were similar in both cohorts (Table 1). Procedural success was similar in both cohorts (97.2% vs. 97.3%; p=1.ehab724.1647) with similar rates of >mild paravalvular leak (7.7% vs. 10.7%; p=0.3796). Mortality and rates of stroke were extremely low and similar in both cohorts at 30 days and 1 year (Table 2). There was a trend towards lower rates of permanent pacemaker implantation in the SAPIEN 3 Ultra cohort (In-Hospital: 9.2% vs.4.5%, p=0.2177; 30-Day: 11.3% vs.4.5%, p=0.0658; 1-Year: 12.7% 5.4%, p=0.0536). Conclusions In this real-world analysis of contemporary TAVI patients across the risk spectrum, the SAPIEN 3 Ultra THV demonstrated excellent short-term outcomes comparable to the SAPIEN 3 THV with a trend towards lower rates of permanent pacemaker implantation. FUNDunding Acknowledgement Type of funding sources: None.

Author(s):  
Helge Möllmann ◽  
David M. Holzhey ◽  
Michael Hilker ◽  
Stefan Toggweiler ◽  
Ulrich Schäfer ◽  
...  

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract


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