Objectives To evaluate the incidence of in‐hospital postoperative delirium (IHPOD) after transcatheter aortic valve replacement (TAVR). Design Systematic review and meta‐analysis. Setting Elective procedures Participants Individuals undergoing TAVR. Measurements A literature search was conducted in PubMed, Embase, BioMedCentral, Google Scholar, and the Cochrane Central Register of Controlled Trials (up to December 2017). All observational studies reporting the incidence of IHPOD after TAVR (sample size > 25) were included in our meta‐analysis. The reported incidence rates were weighted to obtain a pooled estimate rate with 95% confidence interval (CI). Results Of 96 potentially relevant articles, 31 with a total of 32,389 individuals who underwent TAVR were included in the meta‐analysis. The crude incidence of IHPOD after TAVR ranged from 0% to 44.6% in included studies, with a pooled estimate rate of 8.1% (95% CI=6.7–9.4%); heterogeneity was high (Q = 449; I = 93%; pheterogeneity < .001). The pooled estimate rate of IHPOD was 7.2% (95% CI=5.4–9.1%) after transfemoral (TF) TAVR and 21.4% (95% CI=10.3–32.5%) after non‐TF TAVR. Conclusion Delirium occurs frequently after TAVR and is more common after non‐TF than TF procedures. Recommendations are made with the aim of standardizing future research to reduce heterogeneity between studies on this important healthcare problem. J Am Geriatr Soc 66:2417–2424, 2018.
Background: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm 2 or perimeter ≥85 mm) and extra-large (≥683 mm 2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. Methods: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. Results: Median aortic annulus area and perimeter were 617 mm 2 (591–657) and 89.1 mm (87.0–92.1), respectively (704 mm 2 [689–743] and 96.0 mm [94.5–97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P =0.001), with a higher rate of significant paravalvular leak ( P =0.004), second valve implantation ( P =0.013), and valve embolization ( P =0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. Conclusions: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.
Objectives To compare the outcomes of transfemoral ACURATE neo (NEO) and Sapien 3 (S3) patients in terms of device success and clinical safety outcomes using a propensity score analysis. Background Differences in clinical outcomes between the latest‐generation balloon‐expandable S3 and self‐expanding NEO in a “real‐world transfemoral TAVI population” are still unclear. Methods We compared up to 6 months clinical outcomes using a propensity score analysis (inverse probability of treatment weighting [IPTW]) to account for differences in baseline characteristics. Results A total of 345 patients underwent transfemoral transcatheter aortic valve implantation (TAVI) with either NEO or S3 at two centers in the Netherlands. Composite device success and early safety endpoints were comparable between NEO and S3 (Device success: IPTW‐adjusted OR: 0.35 [95% CI: 0.12–1.18], and early safety: IPTW‐adjusted OR: 0.51 [95% CI: 0.19–1.38]). Six‐months mortality was 5.3 versus 3.6%, stroke was 2.8 versus 3.3%, and pacemaker rate was 6.1 versus 8.6%, respectively with p = NS. Mean aortic gradient was lower in the NEO group (5.72 ± 2.47 vs. 9.05 ± 3.48; p = <.001), with a comparable rate of moderate or severe paravalvular leak (0 versus 2.1%; p = NS). Conclusions Device success and clinical safety outcomes were comparable for both valves. Up to 6‐months follow‐up clinical outcomes and mortality rate remained excellent. Mean aortic gradient was lower after ACURATE neo implantation.
BackgroundThe timing of onset and associated predictors of late new conduction disturbances (CDs) leading to permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI) are still unknown, however, essential for an early and safe discharge. This study aimed to investigate the timing of onset and associated predictors of late onset CDs in patients requiring PPI (LCP) following TAVI.Methods and resultsWe performed retrospective analysis of prospectively collected data from five large volume centres in Europe. Post-TAVI electrocardiograms and telemetry data were evaluated in patients with a PPI post-TAVI to identify the onset of new advanced CDs. Early onset CDs were defined as within 48 hours after procedure, and late onset CDs as after 48 hours. A total of 2804 patients were included for analysis. The PPI rate was 12%, of which 18% was due to late onset CDs (>48 hours). Independent predictors for LCP were pre-existing non-specific intraventricular conduction delay, pre-existing right bundle branch block, self-expandable valves and predilation. At least one of these risk factors was present in 98% of patients with LCP. Patients with a balloon-expandable valve without predilation did not develop CDs requiring PPI after 48 hours.ConclusionsSafe early discharge might be feasible in patients without CDs in the first 48 hours after TAVI if no risk factors for LCP are present.
Accuracy of aortic regurgitation (AR) quantification by magnetic resonance (MR) imaging in the presence of a transcatheter heart valve (THV) remains to be established. We evaluated the accuracy of cardiac MR velocity mapping for quantification of antegrade flow (AF) and retrograde flow (RF) across a THV and the optimal slice position to use in cardiac MR imaging. In a systematic and fully controlled laboratory ex vivo setting, two THVs (Edwards SAPIEN XT, Medtronic CoreValve) were tested in a porcine model ( n = 1) under steady flow conditions. Results showed a high level of accuracy and precision. For both THVs, AF was best measured at left ventricular outflow tract level, and RF at ascending aorta level. At these levels, MR had an excellent repeatability (ICC > 0.99), with a tendency to overestimate (4.6 ± 2.4% to 9.4 ± 7.0%). Quantification of AR by MR velocity mapping in the presence of a THV was accurate, precise, and repeatable in this pilot study, when corrected for the systematic error and when the best MR slice position was used. Confirmation of these results in future clinical studies would be a step forward in increasing the accuracy of the assessment of paravalvular AR severity.
Post-TAVI ICS are an uncommon complication independently associated with high early mortality. Currently, most therapeutic alternatives yield poor results but percutaneous closure of AICS was feasible and is a promising alternative.
Background and objectivesPeriprosthetic aortic regurgitation (PPR) after transcatheter aortic valve implantation (TAVI) remains an important issue associated with impaired long-term outcomes. The current randomised study aims to evaluate potential differences between the balloon-expandable Edwards SAPIEN-3 and the self-expanding Medtronic CoreValve system with the main focus on post-TAVI PPR by means of novel imaging endpoints, and an additional focus on other clinical endpoints.EndpointsThe primary endpoint of this study is quantitative assessment of the severity of post-procedural PPR using cardiac magnetic resonance imaging. Several other novel imaging modalities (X-ray contrast angiography, echocardiography) are used as secondary imaging modalities for the assessment of PPR following TAVI. Secondary objectives of the study include clinical outcomes such as cerebral and kidney injury related to TAVI, and quality of life.Methods and designThe ELECT study is a single-centre, prospective, two-armed randomised controlled trial. For the purpose of this study, 108 consecutive adult patients suitable for transfemoral TAVI will be randomly allocated to receive the SAPIEN-3 (n = 54) or the CoreValve system (n = 54).DiscussionThe ELECT trial is the first randomised controlled trial to quantitatively compare the extent of post-TAVI PPR between the SAPIEN-3 and CoreValve. Furthermore, it will evaluate potential differences between the two prostheses with regard to mid-term clinical outcome and quality of life.
Objectives To explore the prevalence of smoking, and its association with clinical and mortality outcome among patients undergoing transcatheter aortic valve replacement (TAVR). Background Less data exist regarding the effect of baseline smoking status on clinical and mortality outcome among patients undergoing TAVR. Methods Consecutive patients who underwent TAVR at two high volume Dutch centers were included. Smoking status was prospectively questioned by a structured interview at admission. Primary endpoint was 1‐year all‐cause mortality after TAVR. Results A total of 913 consecutive patients (80.1 ± 7.6 years; logistic EuroSCORE: 16.5 ± 9.9%) who underwent TAVR for severe aortic valve stenosis were included. There were 47% (n = 432) males, and 57% (n = 522) never‐smokers, and 35% (n = 317) prior‐smokers, and 8% (n = 74) current‐smokers. Smokers (i.e., prior‐smokers or current‐smokers) were younger compared to never‐smokers (78.9 ± 7.9 and 76.4 ± 8.0 vs. 81.3 ± 7.1, P < 0.000, respectively). Median follow‐up time was 365 (interquartile range [IQR]: 280–365) days. Overall, prior‐smoking was not associated with all‐cause mortality at 1‐year following TAVR (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.55–1.23). After stratification according to sex, male prior‐smokers showed better 1‐year survival after TAVR than male never‐smokers (12% vs. 20%; P = 0.018, respectively, HR 0.52, 95% CI 0.29–0.89), while this reversed effect was not observed among female prior‐smokers versus female never‐smokers after TAVR (HR 1.70, 95% CI 0.95–3.05). Conclusions Overall, baseline prior‐smokers had similar 1‐year mortality outcome after TAVR compared with baseline never‐smokers. However, there was a reversed association between baseline prior‐smoking status and 1‐year mortality after TAVR among males, which could partially be explained due to the favorable baseline characteristics.
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