Prospective evaluation of clinical outcomes in all-comer high-risk patients with aortic valve stenosis undergoing medical treatment, transcatheter or surgical aortic valve implantation following heart team assessment.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has been proposed as a treatment alternative for patients with aortic valve stenosis (AS) at high or prohibitive risk for surgical aortic valve replacement (AVR). We aimed to assess real-world outcomes after treatment according to the decisions of the multidisciplinary heart team. METHODS: At a tertiary centre, all high-risk patients referred between 1 March 2008 and 31 October 2011 for symptomatic AS were screened and planned to undergo AVR, TAVI or medical treatment. We report clinical outcomes as defined by the Valve Academic Research Consortium. RESULTS: Of 163 high-risk patients, those selected for AVR had lower logistic EuroSCORE and STS scores when compared with TAVI or medical treatment (median [interquartile range] 18 [12-26]; 26 [17-36]; 21 [14-32]% (P = 0.015) and 6.5 [5.1-10.7]; 7.6 [5.8-10.5]; 7.6 [6.1-15.7]% (P = 0.056)). All-cause mortalities at 1 year in 35, 73 and 55 patients effectively undergoing AVR, TAVI and medical treatment were 20, 21 and 38%, respectively (P = 0.051). Cardiovascular death and major stroke occurred in 9, 8 and 33% (P < 0.001) and 6, 4 and 2% (P = 0.62), respectively. For patients undergoing valve implantation, device success was 91 and 92% for AVR and TAVI, respectively. The combined safety endpoint at 30 days was in favour of TAVI (29%) vs AVR (63%) (P = 0.001). In contrast, the combined efficacy endpoint at 1 year tended to be more favourable for AVR (10 vs 24% for TAVI, P = 0.12). CONCLUSIONS: Patients who are less suitable for AVR can be treated safely and effectively with TAVI with similar outcomes when compared with patients with a lower-risk profile undergoing AVR. Patients with TAVI or AVR have better survival than those undergoing medical treatment only.

Transcatheter aortic valve implantation: evidence on safety and efficacy compared with medical therapy. A systematic review of current literature.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) promises effective treatment for high-risk elderly patients with symptomatic severe aortic stenosis (AS). However, the adoption of TAVI must be justified and guarantee long-term performance. Systematic reviews are a core methodology in evidence-based health economics for judging medical effectiveness. In this work, the methodology was applied to provide objective evidence on the efficacy and safety of TAVI at 1-year follow-up and to assess whether TAVI confers a survival benefit compared with medical therapy. METHODS: In accordance with the toolkit of the "German Scientific Working Group Technology Assessment for Health Care" (GSWG), a systematic literature review on the safety and efficacy of TAVI procedures was conducted in major bibliographic databases to identify all relevant publications. Preestablished inclusion criteria were defined. An initial screening of identified articles regarding titles and abstracts was followed by a full-text screening. Data from eligible articles were extracted and evaluated according to GSWG checklists followed by a qualitative synthesis of information. RESULTS: The systematic literature search identified 12 primary publications (derived from 1,849 citations) for TAVI [number of patients (n) = 1,049] and 11 publications (derived from 189 citations) for medical therapy of AS (n = 946) that fulfilled the inclusion criteria. Mean overall procedural success rate for included TAVI interventions was 93.3%. Mean combined procedural, post-procedural, and cumulative in-hospital/30-day mortality was 11.4% (n = 116; range 5.3-23%). 1 year after TAVI, the mean overall survival rate was 75.9% (range 64.1-87%) compared with 62.4% (range 40-84.8%) for medically treated patients (p value < 0.01). 1-year survival after TAVI for patients treated with transvascular (TV) procedures was higher than after transapical (TA) procedures (79.2 vs. 73.6%) (p value = 0.04). At 1-year follow-up, the improved valvular function remained stable, and there was a trend towards an improved ventricular function. CONCLUSION: Based on the best available data, in patients with symptomatic severe AS, TAVI demonstrates an improved 1-year survival compared with medical treatment. The survival benefit of TV-TAVI over medical therapy elucidated from this systematic literature review is +16.8% and therefore, in good congruence with the recently published results from the randomized PARTNER US trial (+20%).

Impact of pressure recovery on echocardiographic assessment of asymptomatic aortic stenosis: a SEAS substudy.

OBJECTIVES: The aim of this analysis was to assess the diagnostic importance of pressure recovery in evaluation of aortic stenosis (AS) severity. BACKGROUND: Although pressure recovery has previously been demonstrated to be particularly important in assessment of AS severity in groups of patients with moderate AS or small aortic roots, it has never been evaluated in a large clinical patient cohort. METHODS: Data from 1,563 patients in the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study was used. Inner aortic diameter was measured at annulus, sinus, sinotubular junction, and supracoronary level. Aortic valve area index (AVAI) was calculated by continuity equation and pressure recovery and pressure recovery adjusted AVAI (energy loss index [ELI]), by validated equations. Primarily, sinotubular junction diameter was used to calculate pressure recovery and ELI, but pressure recovery and ELI calculated at different aortic root levels were compared. Severe AS was identified as AVAI and ELI < or =0.6 cm(2)/m(2). Patients were grouped into tertiles of peak transaortic velocity. RESULTS: Pressure recovery increased with increasing peak transaortic velocity. Overestimation of AS severity by unadjusted AVAI was largest in the lowest tertile and if pressure recovery was assessed at the sinotubular junction. In multivariate analysis, a larger difference between AVAI and ELI was associated with lower peak transaortic velocity (beta = 0.35) independent of higher left ventricular ejection fraction (beta = -0.049), male sex (beta = -0.075), younger age (beta = 0.093), and smaller aortic sinus diameter (beta = 0.233) (multiple R(2) = 0.18, p < 0.001). Overall, 47.5% of patients classified as having severe AS by AVAI were reclassified to nonsevere AS when pressure recovery was taken into account. CONCLUSIONS: For accurate assessment of AS severity, pressure recovery adjustment of AVA must be routinely performed. Estimation of pressure recovery at the sinotubular junction is suggested.

Ezetimibe--an update.

Ezetimibe (Ezetrol - MSD-Schering Plough) is a lipid-lowering drug that reduces plasma concentrations of low-density lipoprotein (LDL) cholesterol and total cholesterol when used alone or in combination with a statin. In 2004, we could find no evidence on the effects of ezetimibe on cardiovascular morbidity and mortality and concluded that it should not replace a statin in the routine management of patients at increased risk of developing complications of atherosclerotic disease.1 Since then, a fixed-dose combination product, containing simvastatin and ezetimibe ( Inegy - MSD-Schering Plough), has been launched in the UK, and new evidence on the safety and efficacy of ezetimibe has been published. Here we reconsider ezetimibe in light of the new product and data.