Patients being considered for transcatheter aortic valve replacement (TAVR) are frequently diagnosed with coronary artery disease. In patients requiring revascularization, there is a paucity of data ...informing when to perform percutaneous coronary artery intervention (PCI). We evaluated the impact of PCI timing on clinical outcomes and readmissions after TAVR. From the National Readmissions Database 2016 to 2019, we stratified the duration between PCI and TAVR into 3 groups: same-day PCI and TAVR, TAVR ≤30 days after PCI, and TAVR >30 days after PCI. We then compared primary and secondary outcomes among them. A total of 5207 patients were included, 1413 (27.1%) of whom underwent PCI and TAVR on the same day, while 2161 (41.5%) underwent TAVR ≤30 days after PCI, and 1632 (31.3%) underwent TAVR >30 days after PCI. There was no significant difference for in-hospital mortality among the groups (adjusted odds ratio aOR 0.49, 95% confidence interval CI 0.16-1.48, p = 0.203 for same-day versus ≤30 days; aOR 2.07, 95% CI 0.68-6.30, p = 0.199 for same-day versus >30 days). Patients who underwent TAVR ≤30 days after PCI had higher odds of acute kidney injury (aOR 1.49, 95% CI 1.05-2.10, p = 0.024), nonhome discharge (aOR 1.53, 95% CI 1.20-1.96, p = 0.001), and 90-day readmission (aOR 1.35, 95% CI 1.04-1.76, p = 0.026) compared with those who underwent same-day PCI and TAVR. Concomitant PCI and TAVR was associated with lower rates of 90-day readmissions and acute kidney injury compared with TAVR shortly after PCI (<30 days) and should be considered in select patients.
The graphical abstract illustrates the main findings of this study, which compared PCI ≤30 days before TAVR and PCI >30 days before TAVR with same-day PCI and TAVR.
Abbreviations: PCI, percutaneous coronary intervention; TAVR, transcatheter aortic valve replacement Display omitted
To evaluate all-cause mortality in ViV-TAVI versus redo SAVR in patients with failed bioprostheses.
Study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of ...non-randomized studies published by September 30, 2021.
Ten studies met our eligibility criteria and included a total of 3345 patients (1676 patients underwent ViV-TAVI and 1669 patients underwent redo SAVR). Pooling all the studies, ViV-TAVI showed a lower risk of all-cause mortality in the first 44 days hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.49–0.93, P = 0.017, with an HR reversal after 197 days favoring redo SAVR (HR 1.53; 95% CI 1.22–1.93; P < 0.001). Pooling only the matched populations (1143 pairs), ViV-TAVI showed a lower risk of all-cause mortality in the first 55 days hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.45–0.89, P < 0.001, with a reversal HR after 212 days favoring redo SAVR (HR 1.57; 95% CI 1.22–2.03; P < 0.001). The Cox regression model showed a statistically significant association of prosthesis-patient mismatch (PPM) with all-cause mortality during follow-up for ViV-TAVI (HR 1.03 per percentage increase in the study- and treatment arm-level proportion of PPM, 95% 1.02–1.05, P < 0.001).
ViV-TAVI is associated with a strong protective effect immediately after the procedure in comparison with redo SAVR, however, this initial advantage reverses over time and redo SAVR seems to be a protective factor for all-cause mortality after 6 months. Considering that these results are the fruit of pooling data from observational studies, they should be interpreted with caution and trials are warranted.
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•Structural valve degeneration of bioprosthetic heart valves is a concerning issue.•Redo surgical intervention is burdened by higher risk of death especially immediately after the procedure.•ViV-TAVI offers an excellent alternative to treat patients with failed bioprostheses, however, redo surgical intervention is associated with better survival over time.•Prosthesis-patient mismatch may play a major role in this scenario.
Abstract Objective Transcatheter heart valve implantation in failed aortic bioprostheses (valve-in-valve ViV) is an increasingly used therapeutic option for high-risk patients. However, high ...postprocedural gradients are a significant limitation of aortic ViV. Our objective was to evaluate Medtronic CoreValve Evolut R ViV hemodynamics in relation to the degree of device oversizing and depth of implantation. Methods Evolut R devices of 23 and 26 mm were implanted within 21-, 23-, and 25-mm Hancock II bioprostheses. Small and gradual changes in implantation depth were attempted. Hemodynamic testing was performed in a pulse duplicator under ISO-5840 standard. Results A total of 47 bench-testing experiments were performed. The mean gradient of the 26-mm Evolut R in 23- and 25-mm Hancock II was lower than 23-mm Evolut R ( P < .001). However, the mean gradient of 26-mm Evolut R in 21-mm Hancock II bioprostheses R (ranging from 21.30 ± 0.23 to 24.30 ± 0.22 mm Hg) was worse than 23-mm Evolut R (ranging from 15.94 ± 0.18 to 20.35 ± 0.16 mm Hg, P < .001). Furthermore, our results suggest that supra-annular implantation of 23-mm and 26-mm Evolut R devices within the bioprostheses can lead to lower gradient and improved leaflet coaptation. Regardless of implantation depth, superior transvalvular gradient is expected with 26-mm Evolut R than 23-mm Evolut R in a nonstenotic Hancock II with a true internal diameter > 17.5 mm. Conclusions The current comprehensive bench-testing assessment demonstrates the importance of both transcatheter heart valve size and device position for the attainment of optimal hemodynamics during ViV procedures. Additional in vitro testing may be required to develop hemodynamics-based guidelines for device sizing in ViV procedures in degenerated surgical bioprostheses.
BACKGROUND:Limited data exist on clinical valve thrombosis after transcatheter aortic valve-in-valve (ViV) implantation. Our objective was to determine the incidence, timing, clinical ...characteristics, and treatment outcomes of patients diagnosed with clinical ViV thrombosis.
METHODS AND RESULTS:Centers participating in the Valve-in-Valve International Data Registry were surveyed for thrombosis cases, and clinical valve thrombosis was defined based on a combination of the presence of new valve dysfunction and an imaging evidence of leaflet thrombosis. Three hundred ViV implantations were included. The surgical valve was stented in 86.3% and stentless in 13.7% of cases; and the transcatheter heart valve was self-expanding in 50%, balloon-expandable in 49%, and mechanically expanding in 1.0%. The incidence of clinical valve thrombosis was 7.6% (n=23), diagnosed at a median time of 101 days (interquartile range, 21–226) after the procedure. Fifteen patients (65%) presented with worsening symptoms and 21 (91%) with transvalvular mean gradient elevation. The mean gradient at the time of diagnosis (median 39 mm Hg; interquartile range, 30–44) was significantly higher than immediately post-ViV (13 mm Hg; interquartile range, 8–20.5; P<0.001) and was significantly reduced after oral anticoagulation therapy (17.5 mm Hg; interquartile range, 11–20.5; P<0.001). There were no deaths or strokes related to valve thrombosis. Factors associated with valve thrombosis were oral anticoagulation (odds ratio 95% confidence limits0.067 0.008–0.543, P=0.011), surgical valve true internal diameter indexed to body surface area (0.537 0.331–0.873, P=0.012), and Mosaic or Hancock II stented porcine bioprostheses (4.01 1.287–12.485, P=0.017).
CONCLUSIONS:Clinical valve thrombosis after transcatheter aortic ViV implantation is common, especially in patients not on oral anticoagulation. Although aortic ViV is commonly associated with elevated gradients, valve thrombosis should be ruled out if gradients increase compared with early postprocedural values. A higher incidence was observed after treatment of certain stented porcine surgical valve types, suggesting a specific adjustment of the adjunctive antithrombotic therapy in this subset of ViV patients.
Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly ...with the use of newer-generation transcatheter heart valves (THVs).
The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures.
Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months interquartile range: 3 to 41 months) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs.
A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio OR: 1.05 for each increase of 1 year; 95% confidence interval CI: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups).
In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.
The outcome and interpretation of noninferiority trials depend on the magnitude of the noninferiority margin and whether a relative or absolute noninferiority margin is used and may be affected by ...imprecision in event rate estimation.
To assess the consequence of imprecise event rate estimations on interpretation of peer-reviewed randomized clinical trials.
PubMed/MEDLINE was searched for articles published between January 1, 2015, and April 30, 2021.
Noninferiority randomized clinical trials of coronary stents published in selected journals with clinical events as the primary end point.
Two reviewers (M.S. and F.V.) independently extracted data on trial characteristics, noninferiority assumptions, primary end point clinical outcomes, and study conclusions. Overestimation or underestimation of the control event rate was evaluated by dividing the assumed control event rate by the observed control event rate. For noninferiority end points with absolute margins, the assumed corresponding relative margin was defined as the ratio of the absolute margin and the assumed event rate, and the observed corresponding relative margin as the ratio between the absolute margin and the observed event rate in the control arm. Noninferiority comparisons with absolute margins were reanalyzed using the assumed corresponding relative margin and the Farrington-Manning score test for relative risk.
Overestimation or underestimation, assumed and observed corresponding relative margins, and relative reanalysis of the primary end points of trials with absolute margins.
A total of 106 989 patients from 58 trials were included. The event rate in the control arms was overestimated by a median (IQR) of 28% (2%-74%). Most noninferiority trials used absolute rather than relative margins (55 of 58 trials 94.8%). Owing to overestimation, absolute noninferiority margins became more permissive than originally assumed (median IQR of observed relative noninferiority margin, 1.62 1.50-1.80 vs assumed relative noninferiority margin, 1.47 1.39-1.55; P < .001). Among trial comparisons that met noninferiority with an absolute noninferiority margin, 17 of 50 trials (34.0%) would not have met noninferiority with a corresponding assumed relative noninferiority margin.
In this systematic review and meta-analysis, assumed event rates were often overestimated in noninferiority coronary stent trials. Because most of these trials use absolute margins to define noninferiority, such overestimation results in excessively permissive relative noninferiority margins.
Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the “off-label” use of transcatheter heart ...valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p <0.001). The difference was driven by lower rates of device malpositioning (9% vs 33%) and aortic regurgitation (AR) ≥ moderate (4% vs 31%) and translated into higher clinical efficacy at 30 days in patients treated with newer as compared with early generation THV (72% vs 56%, p = 0.041). Both THV under- and oversizing were associated with an increased risk of THV malpositioning. In conclusion, TAVI is a feasible treatment strategy in selected high-risk patients with NAVR but is associated with a considerable risk of THV malpositioning and residual AR. Although newer-generation THV are associated with better outcomes, novel devices for the treatment of NAVR are warranted.
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