Dataset Information

A prospective, non-randomized comparison of SAPIEN XT and CoreValve implantation in two sequential cohorts of patients with severe aortic stenosis.

ABSTRACT: OBJECTIVES: Few data is available comparing Edwards SAPIEN XT - SXT (Edwards Lifesciences, Irvine, California) with Medtronic CoreValve - CoV (Medtronic Inc., Minneapolis, Minnesota) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). METHODS: We selected consecutive patients undergoing transfemoral TAVR with SXT or CoV at our Institution. Main outcomes were Valve Academic Research Consortium (VARC)-combined safety endpoints. RESULTS: A total of 100 patients (SXT, n=50 versus CoV, n=50) were analyzed. Both SXT and CoV showed good device success rates (98% versus 90%, p=0.20). SXT versus CoV reduced the occurrence of paravalvular regurgitation after TAVR (26% versus 90%, p<0.0001) though not affecting the rate of moderate/severe regurgitation (p=0.20). SXT versus CoV required less frequently a permanent pacemaker after TAVR (8% versus 38%, p<0.0001). In-hospital major vascular complications (8% versus 4%, p>0.99), life-threatening bleedings (2% versus 4%, p>0.99), stroke (4% versus 6%, p>0.99) and death (6% versus 2%, p>0.99) did not differ between SXT and CoV. However, safety endpoints favored SXT (17% versus 34.6%, p=0.01), due to a numerically higher incidence of ischemic stroke and Acute Kidney Injury Stage 3 after CoV. At multivariate analysis, TAVR with SXT (odds ratio=0.21, 95% confidence intervals [0.05-0.84], p=0.03) was predictive of fewer adverse events. CONCLUSIONS: Transcatheter valve implantation with Edwards SAPIEN XT was associated with lower VARC-combined safety endpoints as compared with Medtronic CoreValve. More extensive cohorts are needed to confirm these results.

SUBMITTER: Kasel AM

PROVIDER: S-EPMC4082233 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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A prospective, non-randomized comparison of SAPIEN XT and CoreValve implantation in two sequential cohorts of patients with severe aortic stenosis.

Kasel Albert Markus AM Cassese Salvatore S Ischinger Thomas T Leber Alexander A Antoni Diethmar D Riess Gotthard G Vogel Jayshree J Kastrati Adnan A Eichinger Walter W Hoffmann Ellen E

American journal of cardiovascular disease 20140628 2

<h4>Objectives</h4>Few data is available comparing Edwards SAPIEN XT - SXT (Edwards Lifesciences, Irvine, California) with Medtronic CoreValve - CoV (Medtronic Inc., Minneapolis, Minnesota) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).<h4>Methods</h4>We selected consecutive patients undergoing transfemoral TAVR with SXT or CoV at our Institution. Main outcomes were Valve Academic Research Consortium (VARC)-combined safety endpoints.<h4>Results< ...[more]

PMID: 25006536

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Project description:BACKGROUND:Transcatheter aortic valve implantation (TAVI) is criticized by some as an expensive treatment in super-elder patients with limited life expectancy. However, there is a knowledge gap regarding the magnitude of clinical benefit provided by TAVI in comparison with conservative management in patients with severe aortic stenosis (AS) in real clinical practice, which would be important in the decision making for TAVI. METHODS:We combined two independent registries, namely CURRENT AS and K-TAVI registries. CURRENT AS was a multicenter registry enrolling 3815 consecutive patients with severe AS irrespective to treatment modalities between January 2003 and December 2011. K-TAVI was a multicenter, prospective registry including 449 consecutive patients with severe AS, who underwent TAVI with SAPIEN XT balloon-expandable valves between October 2013 and June 2016. In these 2 registries, 449 patients received TAVI and 894 patients were managed with conservative strategy. We conducted propensity score matching and finally obtained a cohort of 556 patients (278 patients for each group) for the analysis. The primary outcome measures were all-cause death and heart failure (HF) hospitalization at 2-year. RESULTS:The cumulative 2-year incidences of all-cause death and HF hospitalization were significantly lower in the TAVI group than in the conservative group (16.8% versus 36.6%, P<0.001, and 10.7% versus 37.2%, P<0.001). After adjusting the residual confounders, TAVI reduced the risks of all-cause death (HR, 0.46; 95%CI, 0.32-0.69; P = 0.0001) and HF hospitalizations (HR, 0.25; 95%CI, 0.16-0.40; P<0.0001) compared with conservative strategy. There was no difference in the cumulative incidence of non-cardiovascular death between the 2 groups. CONCLUSIONS:TAVI in the early Japanese experience was associated with striking risk reduction for all-cause death as well as HF hospitalization as compared with the historical cohort of patients with severe AS who were managed conservatively just before introduction of TAVI in Japan.

Project description:BackgroundBicuspid aortic valve (BAV) is common congenital malformation, bicuspid aortic stenosis accounts for a substantial proportion of patients with aortic valve stenosis (AS). Bicuspid AS are more likely to have aortic dilatation with slightly less elliptical annuli, which might lead to paravalvular aortic valve regurgitation (AR) and permanent pacemaker implantation (PPM) after TAVI with higher mortality. Our study aims to understand the therapeutic efficacy and safety of transcatheter aortic valve implantation (TAVI) with a supra-annular structure-based sizing strategy in Chinese AS patients with BAV versus tricuspid aortic valve (TAV).MethodsSeventy-four consecutive tricuspid AS patients and 44 bicuspid AS patients were included and enrolled in the study for analysis. Both groups underwent TAVI performed using balloon sizing less than mild paravalvular AR to assess the proper prosthesis size. The myocardial function within 1 year postoperative were sequentially evaluated using the New York Heart Association (NYHA) class, and echocardiography measurements. The incidence rates of complications at 30 days and 1 year were analyzed. During the 1-year follow-up, the time of death from any cause or complications in both groups was recorded.ResultsThe study found that the percentage of patients with class III-IV of NYHA dropped after TAVI in both groups, and no significant difference between both groups at 1 year. Compared with the tricuspid AS group patients, Bicuspid group patients had more improvement in mean aortic valve gradient from baseline to 1year (-47.47±13.38 vs. -50.22±19.25 mmHg, P<0.05). There were no significant differences in 30-day and one-year compliance outcomes except a lower incidence of AR at post-procedure and 30 days in the tricuspid AS group as the Bicuspid AS group. There were no statistically significant differences in the time of death from any cause or significant complications between groups.ConclusionsTAVI has acceptable therapeutic efficacy and safety and is feasible for AS patients with BAV in China.

Dataset Information

A prospective, non-randomized comparison of SAPIEN XT and CoreValve implantation in two sequential cohorts of patients with severe aortic stenosis.

Publications

A prospective, non-randomized comparison of SAPIEN XT and CoreValve implantation in two sequential cohorts of patients with severe aortic stenosis.

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