Background-The prognosis and treatment of patients with low-flow (LF) severe aortic stenosis are controversial. Methods and Results-The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with severe aortic stenosis to medical management versus transcatheter aortic valve replacement (TAVR; inoperable cohort) and surgical aortic valve replacement versus TAVR (high-risk cohort). Among 971 patients with evaluable echocardiograms (92%), LF (stroke volume index ≤35 mL/m 2 ) was observed in 530 (55%); LF and low ejection fraction (<50%) in 225 (23%); and LF, low ejection fraction, and low mean gradient (<40 mm Hg) in 147 (15%). Two-year mortality was significantly higher in patients with LF compared with those with normal stroke volume index (47% versus 34%; hazard ratio, 1.5; 95% confidence interval, 1.25-1.89; P=0.006). In the inoperable cohort, patients with LF had higher mortality than those with normal flow, but both groups improved with TAVR (46% versus 76% with LF and 38% versus 53% with normal flow; P<0.001). In the high-risk cohort, there was no difference between TAVR and surgical aortic valve replacement. In patients with paradoxical LF and low gradient (preserved ejection fraction), TAVR reduced 1-year mortality from 66% to 35% (hazard ratio, 0.38; P=0.02). LF was an independent predictor of mortality in all patient cohorts (hazard ratio, ≈1.5), whereas ejection fraction and gradient were not.
Conclusions-LF
BACKGROUND
Little is known about the incidence of prosthesis-patient mismatch (PPM) and its impact on outcomes after transcatheter aortic valve replacement (TAVR).
OBJECTIVES
The objectives of this study were: 1) to compare the incidence of PPM in the transcatheter and surgical aortic valve replacement (SAVR) randomized (RCT) arms of the PARTNER-I trial Cohort A; and 2) to assess the impact of PPM on regression of left ventricular (LV) hypertrophy and mortality in these 2 arms and in the TAVR nonrandomized continued access (NRCA) Registry cohort.
METHODS
The PARTNER trial Cohort A randomized patients 1:1 to TAVR or bioprosthetic SAVR. Postoperative PPM was defined as absent if indexed effective orifice area >0.85, moderate ≥0.65 but ≤0.85, or severe <0.65 cm2/m2. LV mass regression and mortality were analyzed using the SAVR-RCT (n = 270), TAVR-RCT (n = 304) and TAVR-NRCA (n = 1637) cohorts.
RESULTS
Incidence of PPM was 60.0% (severe: 28.1%) in SAVR-RCT versus 46.4% (severe: 19.7%) in TAVR-RCT (p < 0.001) and 43.8% (severe: 13.6%) in TAVR-NRCA. In patients with aortic annulus diameter < 20 mm, severe PPM developed in 33.7% undergoing SAVR compared to 19.0% undergoing TAVR (p = 0.002). PPM was an independent predictor of less LV mass regression at 1 year in SAVR-RCT (p = 0.017) and TAVR-NRCA (p = 0.012) but not in TAVRRCT (p = 0.35). Severe PPM was an independent predictor of 2-year mortality in SAVR-RCT (hazard ratio [HR]: 1.78; p = 0.041) but not in TAVR-RCT (HR: 0.58; p = 0.11). In the TAVRNRCA, severe PPM was not a predictor of 1-year mortality in the whole cohort (HR: 1.05; p = 0.60) but did independently predict mortality in the subset of patients with no post-procedural aortic regurgitation (HR: 1.88; p = 0.02).
CONCLUSIONS
In patients with severe aortic stenosis and high surgical risk, PPM is more frequent and more often severe following SAVR than TAVR. Patients with PPM after SAVR have worse survival and less LV mass regression than those without PPM. Severe PPM also has a significant impact on survival after TAVR in the subset of patients with no post-procedural aortic regurgitation. TAVR may be preferable to SAVR in patients with a small aortic annulus who are susceptible to PPM to avoid its adverse impact on LV mass regression and survival.
Background—
The effect of preoperative mitral regurgitation (MR) on clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. This study sought to examine the impact of moderate and severe MR on outcomes after TAVR and surgical aortic valve replacement (SAVR).
Methods and Results—
Data were drawn from the randomized Placement of Aortic Transcatheter Valve (PARTNER) Trial cohort A patients with severe, symptomatic aortic stenosis undergoing either TAVR (n=331) or SAVR (n=299). Both TAVR and SAVR patients were dichotomized according to the degree of preoperative MR (moderate/severe versus none/mild). At baseline, moderate or severe MR was reported in 65 TAVR patients (19.6%) and 63 SAVR patients (21.2%). At 30 days, among survivors who had isolated SAVR/TAVR, moderate/severe MR had improved in 25 SAVR patients (69.4%) and 30 TAVR patients (57.7%), was unchanged in 10 SAVR patients (27.8%) and 19 TAVR patients (36.5%), and worsened in 1 SAVR patient (2.8%) and 4 TAVR patients (5.8%; all
P
=NS). Mortality at 2 years was higher in SAVR patients with moderate or severe MR than in those with mild or less MR (49.8% versus 28.1%; adjusted hazard ratio, 1.73; 95% confidence interval, 1.01–2.96;
P
=0.04). In contrast, MR severity at baseline did not affect mortality in TAVR patients (37.0% versus 32.7%, moderate/severe versus none/mild; hazard ratio, 1.14; 95% confidence interval, 0.72–1.78;
P
=0.58;
P
for interaction=0.05).
Conclusions—
Both TAVR and SAVR were associated with a significant early improvement in MR in survivors. However, moderate or severe MR at baseline was associated with increased 2-year mortality after SAVR but not after TAVR. TAVR may be a reasonable option in selected patients with combined aortic and mitral valve disease.
Clinical Trial Registration—
URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00530894.
Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.
Let A1, A2,…,Ak be a finite set of contractive, affine, invertible self-mappings of R2. A compact subset Λ of R2 is said to be self-affine with affinitiesA1, A2,…,Ak ifIt is known [8] that for any such set of contractive affine mappings there is a unique (compact) SA set with these affinities. When the affine mappings A1, A2,…,Ak are similarity transformations, the set Λ is said to be self-similar. Self-similar sets are well understood, at least when the images Ai(Λ) have ‘small’ overlap: there is a simple and explicit formula for the Hausdorff and box dimensions [12, 10]; these are always equal; and the δ-dimensional Hausdorff measure of such a set (where δ is the Hausdorff dimension) is always positive and finite.
Acute kidney injury (AKI) is associated with a poor prognosis after transcatheter aortic valve replacement (TAVR). A paucity of data exists regarding the incidence and effect of AKI after TAVR using the new recommended Valve Academic Research Consortium criteria. At Columbia University Medical Center, 218 TAVR procedures (64.2% transfemoral, 35.8% transapical) were performed from 2008 to July 2011. The creatinine level was evaluated daily until discharge. Using the Valve Academic Research Consortium definitions, the 30-day and 1-year outcomes were compared between patients with significant AKI (AKI stage 2 or 3) and those without significant AKI (AKI stage 0 or 1). Significant AKI occurred in 18 patients (8.3%). Of these 18 patients, 10 (55.6%) had AKI stage 3 and 9 (50%) required dialysis. AKI was associated with a lower baseline mean transvalvular gradient (37.6 ± 11.4 vs 45.6 ± 14.8 mm Hg for no AKI, p = 0.03). After TAVR, the AKI group had a greater hemoglobin decrease (3.6 ± 2.0 vs 2.4 ± 1.3 g/dl, p = 0.01), greater white blood cell elevation at 72 hours (21.09 ± 12.99 vs 13.18 ± 4.82 × 103/μl, p = 0.001), a more severe platelet decrease (118 ± 40 vs 75 ± 43 × 103/μl, p <0.0001), and longer hospitalization (10.7 ± 6.4 vs 7.7 ± 8.5 days, p <0.001). One stroke (5.6%) occurred in the AKI group compared with 3 (1.5%) in the group without AKI (p = 0.29). The 30-day and 1-year rates of death were significantly greater in the AKI group than in the no-AKI group (44.4% vs 3.0%, hazard ratio 18.1, 95% confidence interval 6.25 to 52.20, p <0.0001; and 55.6% vs 16.0%, hazard ratio 6.32, 95% confidence interval 3.06 to 13.10, p <0.0001, respectively). Periprocedural life-threatening bleeding was the strongest predictor of AKI after TAVR. In conclusion, the occurrence of AKI, as defined by the Valve Academic Research Consortium criteria, is associated with periprocedural complications and a poor prognosis after TAVR.
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