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BackgroundTranscatheter aortic valve implantation (TAVI) is indicated for patients with aortic stenosis who are intermediate‐high surgical risk. Although all‐cause mortality rates after TAVI are established, survival attributable to the procedure is unclear because of competing causes of mortality. The aim was to report relative survival (RS) after TAVI, which accounts for background mortality risks in a matched general population. Methods and ResultsNational cohort data (n=6420) from the 2007 to 2014 UK TAVI registry were matched by age, sex, and year to mortality rates for England and Wales (population, 57.9 million). The Ederer II method related observed patient survival to that expected from the matched general population. We modelled RS using a flexible parametric approach that modelled the log cumulative hazard using restricted cubic splines. RS of the TAVI cohort was 95.4%, 90.2%, and 83.8% at 30 days, 1 year, and 3 years, respectively. By 1‐year follow‐up, mortality hazards in the >85 years age group were not significantly different from those of the matched general population; by 3 years, survival rates were comparable. The flexible parametric RS model indicated that increasing age was associated with significantly lower excess hazards after the procedure; for example, by 2 years, a 5‐year increase in age was associated with 20% lower excess mortality over the general population. ConclusionsRS after TAVI was high, and survival rates in those aged >85 years approximated those of a matched general population within 3 years. High rates of RS indicate that patients selected for TAVI tolerate the risks of the procedure well.

BackgroundAortic valve predilation with balloon aortic valvuloplasty (BAV) is recommended before transcatheter aortic valve implantation (TAVI), despite limited data around the requirement of this preprocedural step and the potential risks of embolization. This study aimed to investigate the trends in practice and associations of BAV on short‐term outcomes in the UK TAVI registry. Methods and ResultsEleven clinical endpoints were investigated, including 30‐day mortality, myocardial infarction, aortic regurgitation, valve dysfunction, and composite early safety. All endpoints were defined as per the VARC‐2 definitions. Odd ratios of each endpoint were estimated using logistic regression, with data analyzed in balloon‐ and self‐expandable valve subgroups. Propensity scores were calculated using patient demographics and procedural variables, which were included in the models of each endpoint to adjust for measured confounding. Between 2007 and 2014, 5887 patients met the study inclusion criteria, 1421 (24.1%) of whom had no BAV before TAVI valve deployment. We observed heterogeneity in the use of BAV nationally, both temporally and by center experience; rates of BAV in pre‐TAVI workup varied between 30% and 97% across TAVI centers. All endpoints were similar between treatment groups in SAPIEN (Edwards Lifesciences Inc., Irvine, CA) valve patients. After correction for multiple testing, none of the endpoints in CoreValve (Medtronic, Minneapolis, MN) patients were significantly different between patients with or without predilation. ConclusionsPerforming TAVI without predilation was not associated with adverse short‐term outcomes post procedure, especially when using a balloon‐expandable prosthesis. Randomized trials including different valve types are required to provide conclusive evidence regarding the utility of predilation before‐TAVI.

BackgroundPreimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV. Methods and ResultsWe conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random‐effects meta‐analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30‐day all‐cause mortality occurred in 6% (72 of 1282) of patients. Meta‐analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32–1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62–1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23–1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66–1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30–1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49–1.30, P=0.37). ConclusionsOur analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.

Symptomatic aortic stenosis has a poor prognosis. Many patients are considered inoperable or at high surgical risk for surgical aortic valve replacement (SAVR), reflecting their age, comorbidities and frailty. The clinical effectiveness and safety of TAVI have not been reviewed systematically for these high levels of surgical risk. This systematic review compares mortality and other important clinical outcomes up to 5 years post treatment following TAVI or other treatment in these risk groups.A systematic review protocol was registered on the PROSPERO database (CRD42016048396). The Cochrane Library, Centre for Reviews and Dissemination Databases, MEDLINE, EMBASE, and ZETOC were searched from January 2002 to August 2016. Clinical trials or matched studies comparing TAVI with other treatments for AS in patients surgically inoperable or operable at a high risk were included. Data extraction and quality assessment were conducted by two reviewers. Data were pooled using random-effects meta-analysis. The main outcomes were all-cause mortality, efficacy and major complications.Three good quality randomised controlled trials (RCTs) were included. Patients' mean age ranged from 83-85 years, around half were female and New York Heart Association (NYHA) functional class III or IV ranged from 83.8% to 94.2% with frequent comorbidities. In 358 surgically inoperable patients from one RCT, TAVI was superior to medical therapy for all-cause mortality at 1 year (hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.36-0.92), 2 years (HR 0.50, 95% CI 0.39-0.65), 3 years (HR 0.53, 95% CI 0.41to 0.68) and 5 years (HR 0.50, 95% CI 0.39-0.65), and NYHA class III or IV at 2 years (TAVI 16.8% (16/95), medical therapy 57.5% (23/40), p