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Objective The aim of the current study was to identify predictors of paraprosthetic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) and examine its influence on short/medium-term mortality using the UK TAVI Registry. TAVI is an effective treatment for high-risk patients with severe symptomatic aortic stenosis (AS), but paraprosthetic AR has been associated with increased in-hospital and mid-term mortality. Methods Between January 2007 and December 2011, 2584 TAVI procedures were performed in the UK. Patients undergoing ‘valve-in-valve’ procedures, patients with aortic regurgitation as the primary pathology and with no recorded severity of AR were excluded from this analysis (n=144). In total, therefore, 2440 patients were included. Balloon-expandable and self-expanding devices were implanted in 52.7 and 47.2%, respectively, using either transfemoral (67.7%) or non-transfemoral, surgical access (32.3%). Results Postprocedural AR was observed in 68%, mild AR in 57% and moderate-severe in 10%. A large aortic annulus, high preprocedural transaortic gradient, and use of self-expanding valve were independent predictors of moderate-severe AR. Moderate-severe (but not mild) AR was associated with increased mortality, and this relationship appeared significant for the balloon-expandable but not the self-expanding device. Conclusions Our data suggest that a large aortic annulus, high preprocedural transaortic gradient, and use of the self-expanding valve predict moderate-severe AR after TAVI. Such a degree of AR is associated with a significantly worse outcome with the balloon-expandable, but not with the self-expanding valve. Further studies are needed to verify this and explore potential mechanisms.

Objective Current guidelines recommend that most patients aged ≥65 years should undergo mitral valve replacement (MVR) using a biological prosthesis. The objectives of this study were to assess whether these guidelines are being followed in UK practice, and to investigate whether the guidelines are appropriate based on in-hospital mortality and mid-term survival. Methods Data from the National Institute for Cardiovascular Outcomes Research Adult Cardiac Surgery Audit database from all National Health Service (NHS) hospitals and some private hospitals performing adult cardiac surgery in the UK between April 2001 and March 2011 were analysed. The overall cohort included 3862 patients aged ≥65 years who underwent first-time MVR. Propensity score matching and regression adjustment were used to compare outcomes between prosthesis groups. Results The mean age was 73.0 years (SD 4.9) with 50% of patients having surgery with a mechanical prosthesis. This proportion decreased over the study period and with increasing patient age with marked variation between hospitals. In the propensity-matched cohort, in-hospital mortality in the biological group was 6.9%, and in the mechanical group it was 5.9% giving an unadjusted OR of 1.17 (95% CI 0.84 to 1.63). There was no significant difference in mid-term survival between the matched groups with an unadjusted HR for biological prosthesis of 1.08 (95% CI 0.93 to 1.24). Similar results were found when using regression adjustment on unmatched data. Conclusions Current guidelines concerning age and mitral valve prosthesis choice are not being followed for patients aged ≥65 years. With regards to in-hospital and mid-term mortality, this study demonstrates that there is no difference between prosthesis types.

Objective To assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared with medical management in patients with severe aortic stenosis who are ineligible for conventional aortic valve replacement (SAVR) from the perspective of the UK National Health Service. Design Probabilistic decision analytical model. Methods A decision analytical model was developed to assess the costs and benefits associated with both interventions over a 10-year time horizon. A literature review was performed to identify relevant clinical evidence. Health-related quality of life and mortality were included using data from the PARTNER clinical trial (cohort B). Unit costs were taken from national databases. Costs and benefits were discounted at 3.5% per year, and extensive sensitivity analyses (probabilistic and deterministic) were performed to explore the impact of uncertainty on the cost-effectiveness estimates. Main outcome measure Incremental cost-effectiveness ratio (ICER) with benefits expressed as quality-adjusted life years (QALYs). Results The base case ICER was approximately £16 100 per QALY gained. At a cost-effectiveness threshold of £20 000 per QALY gained, the probability that TAVI was cost-effective compared with medical management was 1.00. The results were robust to changes in key clinical parameters as well as choice of baseline survival data. The observed PARTNER survival data only have to be extrapolated for 2 years to generate an ICER below £30 000 per QALY gained, which is the upper value of the threshold range used by the National Institute for Health and Clinical Excellence in the UK. Conclusions TAVI is highly likely to be a cost-effective treatment for patients with severe aortic stenosis who are currently ineligible for SAVR.

Purpose Transcatheter aortic valve implantation (TAVI), allows treatment of patients with aortic stenosis for whom there were previously no therapeutic options available (or only at prohibitive risk). This, and evolving population demographics, have resulted in a rapid change in the overall management of all patients with aortic valve disease. The purpose of this study was to describe trends in activity levels, demographics and clinical outcomes of all patients who underwent aortic valve implantation (by surgical or catheter based approaches) during the first few years of TAVI roll out in England and Wales. Methods All cardiac surgical procedures and all catheter based implants (TAVIs) in the UK are entered into National Registries hosted by NICOR (National Institute for Cardiovascular Outcomes Research). These Registries have the same infrastructure and contain the same demographic data with compatible definitions. All aortic valve interventions over 5 years between 1 January 2006 and 31 December 2010 were included in this analysis, which was restricted to England and Wales where near 100% mortality tracking could be effected for both Registries. Results 35 406 patients underwent surgical AVR (isolated or with concomitant CABG) (SAVR); 1620 underwent TAVI. The numbers of SAVR peaked in 2008 then declined slightly (for the first time ever in the UK). There was a steady growth in TAVI, so that by 2010 TAVI represented just over 10% of all interventions for aortic stenosis. For patients >80 years old there was almost a 100% increase in all aortic valve interventions (from 1055 up to 2035 in 2010). This increase was about 50% due to an increase in TAVI and 50% SAVR. There was a very marked variation in the rate of uptake of TAVI by geographical region ranging from 1.4 to 36 pmp (rising to between 4.3 and 47 pmp in 2011). The TAVI cohort had a much greater risk profile even in the patients >80 years old. The 30 day and 1 year mortality was predictably higher in the TAVI cohort but this decreased markedly from 13.9% in 2007 to 6.2% in 2010. The trends in the timing of death post procedure between the conventional and TAVI groups will be presented, as will the 2011 data which will have been validated by January 2013 (a further >1000 TAVI procedures). Conclusions By capturing all procedures in England and Wales, this study provides a detailed insight into the evolution of aortic intervention during the introduction of TAVI in a defined population.

The Authors' reply: Van Baal argues that we have under-estimated the cost associated with transcatheter aortic valve implantation (TAVI) and as a result, we have generated an overly-optimistic picture of its cost effectiveness. …