AimsIn patients with aortic stenosis (AS), risk stratification for aortic valve replacement (AVR) relies mainly on valve-related factors, symptoms and co-morbidities. We sought to evaluate the prognostic impact of a newly-defined staging classification characterizing the extent of extravalvular (extra-aortic valve) cardiac damage among patients with severe AS undergoing AVR.Methods and resultsPatients with severe AS from the PARTNER 2 trials were pooled and classified according to the presence or absence of cardiac damage as detected by echocardiography prior to AVR: no extravalvular cardiac damage (Stage 0), left ventricular damage (Stage 1), left atrial or mitral valve damage (Stage 2), pulmonary vasculature or tricuspid valve damage (Stage 3), or right ventricular damage (Stage 4). One-year outcomes were compared using Kaplan–Meier techniques and multivariable Cox proportional hazards models were used to identify 1-year predictors of mortality. In 1661 patients with sufficient echocardiographic data to allow staging, 47 (2.8%) patients were classified as Stage 0, 212 (12.8%) as Stage 1, 844 (50.8%) as Stage 2, 413 (24.9%) as Stage 3, and 145 (8.7%) as Stage 4. One-year mortality was 4.4% in Stage 0, 9.2% in Stage 1, 14.4% in Stage 2, 21.3% in Stage 3, and 24.5% in Stage 4 (Ptrend < 0.0001). The extent of cardiac damage was independently associated with increased mortality after AVR (HR 1.46 per each increment in stage, 95% confidence interval 1.27–1.67, P < 0.0001).ConclusionThis newly described staging classification objectively characterizes the extent of cardiac damage associated with AS and has important prognostic implications for clinical outcomes after AVR.
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.
In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
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