In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.
were linearly related to PVR (Table)however the highest correlation with the severity of PVR was seen with the maximum diameter (r2ϭ0.48, pϽ0.001), mean diameter(r2ϭ0.47, pϽ0.0001), average diameter (r2ϭ0.48, pϽ0.0001) or the annular area (r2ϭ0.48, pϽ0.0001). Conclusions: This study demonstrates that 3DE measurements of the aortic annulus are feasible and are better predictors of PVR after TAVR than 2D sagittal diameter and should be incorporated into the algorithm for balloon-expandable transcatheter valve sizing.Background: Transcatheter aortic valve-in-valve (VIV) implantation is an emerging therapeutic alternative for patients with failed surgical bioprosthesis and may obviate the need for a redo surgery. We aimed to evaluate the clinical results of this technique using a large worldwide registry. Methods: The registry included 416 patients with degenerated aortic bioprosthetic valves (age 77.7 Ϯ 9.7 years; 55.3% men) from 54 cardiac centers. The mode of failure was stenosis (nϭ168, 40.4%), regurgitation (nϭ125, 30%), and combined stenosis and regurgitation (nϭ123, 29.6%). Implanted devices were Edwards SAPIEN (nϭ225), CoreValve (nϭ190) and Melody (nϭ1). Results: Adverse procedural outcomes included 11.1% device malposition and 1.9% ostial coronary obstruction. Post-procedure, valve maximum / mean gradients were 28.5 Ϯ 14.3 mmHg / 16.1 Ϯ 9.0, respectively. Independent predictors for high postprocedural gradients (mean Ն20 mmHg) were baseline bioprosthesis stenosis [vs. regurgitation, odds ratio (OR), 6.33, p Ͻ 0.001)] and the use of the Edwards SAPIEN device (OR 2.1, pϭ 0.008). At 30-day follow-up, all-cause mortality was 7.8% and 87.5% of patients were at New York Heart Association functional class I/II. One-year survival was 82.6%. The strongest independent predictor for 1-year mortality post VIV was baseline bioprosthesis stenosis (vs. regurgitation, OR 3.7, pϭ0.003).
Conclusions:The VIV procedure is clinically effective in most patients, with 1-year results comparable with other TAVR cohorts. Baseline bioprosthetic stenosis is the strongest predictor for both elevated post-procedural gradients and 1-year mortality.
Background:
The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.
Methods:
Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.
Results:
Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% versus 36.3%, log-rank test
P
=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm
2
versus 1.2 cm
2
,
P
<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg,
P
<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%,
P
<0.001) and a new pacemaker (43.7% versus 8.7%,
P
<0.001). Four patients had prosthetic reintervention and no difference was found for functional outcomes.
Conclusions:
These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR.
Clinical Trial Registration:
URL:
https://clinicaltrials.gov
. Unique identifier: NCT01057173.
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