Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis

Abstract

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 TAVR and surgical aortic valve replacement (SAVR) randomized control trial (RCT) arms of the PARTNER (Placement of AoRTic TraNscathetER Valves) 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 the indexed effective orifice area (EOA) was >0.85 cm(2)/m(2), moderate if the indexed EOA was ≥0.65 but ≤0.85 cm(2)/m(2), or severe if the indexed EOA was <0.65 cm(2)/m(2). LV mass regression and mortality were analyzed using the SAVR-RCT (n = 270), TAVR-RCT (n = 304), and TAVR-NRCA (n = 1,637) cohorts.

Results: The incidence of PPM was 60.0% (severe: 28.1%) in the SAVR-RCT cohort versus 46.4% (severe: 19.7%) in the TAVR-RCT cohort (p < 0.001) and 43.8% (severe: 13.6%) in the TAVR-NRCA cohort. In patients with an aortic annulus diameter <20 mm, severe PPM developed in 33.7% undergoing SAVR compared with 19.0% undergoing TAVR (p = 0.002). PPM was an independent predictor of less LV mass regression at 1 year in the SAVR-RCT (p = 0.017) and TAVR-NRCA (p = 0.012) cohorts but not in the TAVR-RCT cohort (p = 0.35). Severe PPM was an independent predictor of 2-year mortality in the SAVR-RCT cohort (hazard ratio [HR]: 1.78; p = 0.041) but not in the TAVR-RCT cohort (HR: 0.58; p = 0.11). In the TAVR-NRCA cohort, severe PPM was not a predictor of 1-year mortality in all patients (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 after 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. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Keywords: Doppler echocardiography; aortic regurgitation; left ventricular mass regression; mortality.

FIGURE 1

Incidence of Prosthesis-Patient Mismatch According to Treatment Type in the High-Risk Cohort of the PARTNER Trial Incidence of prosthesis-patient mismatch (PPM) at first post-implant echocardiogram according to treatment group (SAVR-RCT, TAVR-RCT, and TAVR-NRCA) in the as-treated population of the PARTNER trial (A) and in the subsets of patients with a small aortic annulus diameter (<20mm) (B). Incidence of PPM according to the implantation approach (transfemoral vs. transapical) in the TAVR-RCT and TAVR-NRCA cohorts (C). Incidence of PPM according to the utilization of post-dilation or intraprocedural valve-in-valve procedures in the TAVR-NRCA cohort (D). NRCA = nonrandomized continued access; RCT = randomized clinical trial; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

FIGURE 1

Incidence of Prosthesis-Patient Mismatch According to Treatment Type in the High-Risk Cohort of the PARTNER Trial Incidence of prosthesis-patient mismatch (PPM) at first post-implant echocardiogram according to treatment group (SAVR-RCT, TAVR-RCT, and TAVR-NRCA) in the as-treated population of the PARTNER trial (A) and in the subsets of patients with a small aortic annulus diameter (<20mm) (B). Incidence of PPM according to the implantation approach (transfemoral vs. transapical) in the TAVR-RCT and TAVR-NRCA cohorts (C). Incidence of PPM according to the utilization of post-dilation or intraprocedural valve-in-valve procedures in the TAVR-NRCA cohort (D). NRCA = nonrandomized continued access; RCT = randomized clinical trial; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

FIGURE 1

Incidence of Prosthesis-Patient Mismatch According to Treatment Type in the High-Risk Cohort of the PARTNER Trial Incidence of prosthesis-patient mismatch (PPM) at first post-implant echocardiogram according to treatment group (SAVR-RCT, TAVR-RCT, and TAVR-NRCA) in the as-treated population of the PARTNER trial (A) and in the subsets of patients with a small aortic annulus diameter (<20mm) (B). Incidence of PPM according to the implantation approach (transfemoral vs. transapical) in the TAVR-RCT and TAVR-NRCA cohorts (C). Incidence of PPM according to the utilization of post-dilation or intraprocedural valve-in-valve procedures in the TAVR-NRCA cohort (D). NRCA = nonrandomized continued access; RCT = randomized clinical trial; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

FIGURE 1

Incidence of Prosthesis-Patient Mismatch According to Treatment Type in the High-Risk Cohort of the PARTNER Trial Incidence of prosthesis-patient mismatch (PPM) at first post-implant echocardiogram according to treatment group (SAVR-RCT, TAVR-RCT, and TAVR-NRCA) in the as-treated population of the PARTNER trial (A) and in the subsets of patients with a small aortic annulus diameter (<20mm) (B). Incidence of PPM according to the implantation approach (transfemoral vs. transapical) in the TAVR-RCT and TAVR-NRCA cohorts (C). Incidence of PPM according to the utilization of post-dilation or intraprocedural valve-in-valve procedures in the TAVR-NRCA cohort (D). NRCA = nonrandomized continued access; RCT = randomized clinical trial; SAVR = surgical aortic valve replacement; TAVR = transcatheter aortic valve replacement.

FIGURE 2

Left Ventricular Mass Regression over Time for the Groups of Patients with PPM versus no PPM. LV mass (mean ± SEM) at baseline and different follow-up times according to the presence/absence of PPM in the SAVR-RCT arm (A), TAVR-RCT arm (B), and TAVR-NRCA cohort (C). *Significant difference (p < 0.05) between PPM and no-PPM groups. #Significant difference (p < 0.05) from baseline within each PPM group (green: No PPM; orange: PPM). LV = left ventricular; SEM = standard error of the mean. Other abbreviations as in Figure 1.

FIGURE 2

Left Ventricular Mass Regression over Time for the Groups of Patients with PPM versus no PPM. LV mass (mean ± SEM) at baseline and different follow-up times according to the presence/absence of PPM in the SAVR-RCT arm (A), TAVR-RCT arm (B), and TAVR-NRCA cohort (C). *Significant difference (p < 0.05) between PPM and no-PPM groups. #Significant difference (p < 0.05) from baseline within each PPM group (green: No PPM; orange: PPM). LV = left ventricular; SEM = standard error of the mean. Other abbreviations as in Figure 1.

FIGURE 2

Left Ventricular Mass Regression over Time for the Groups of Patients with PPM versus no PPM. LV mass (mean ± SEM) at baseline and different follow-up times according to the presence/absence of PPM in the SAVR-RCT arm (A), TAVR-RCT arm (B), and TAVR-NRCA cohort (C). *Significant difference (p < 0.05) between PPM and no-PPM groups. #Significant difference (p < 0.05) from baseline within each PPM group (green: No PPM; orange: PPM). LV = left ventricular; SEM = standard error of the mean. Other abbreviations as in Figure 1.

FIGURE 3

All-Cause Mortality According to Presence and Severity of PPM Time-to-death curves for prosthesis-patient mismatch stratified in 2 groups (overall [i.e., moderate + severe] PPM vs. no-PPM) or in 3 groups (severe PPM, moderate PPM, no-PPM) for death from any cause in SAVR-RCT (A and B), TAVR-RCT (C and D), TAVR-NRCA (E and F), and TAVR-NRCA excluding patients with mild or greater total aortic regurgitation (G and H). For the panels B, D, F, E, the log-rank p values refer to the 3-group comparison. Abbreviations as in Figure 1.

FIGURE 3

All-Cause Mortality According to Presence and Severity of PPM Time-to-death curves for prosthesis-patient mismatch stratified in 2 groups (overall [i.e., moderate + severe] PPM vs. no-PPM) or in 3 groups (severe PPM, moderate PPM, no-PPM) for death from any cause in SAVR-RCT (A and B), TAVR-RCT (C and D), TAVR-NRCA (E and F), and TAVR-NRCA excluding patients with mild or greater total aortic regurgitation (G and H). For the panels B, D, F, E, the log-rank p values refer to the 3-group comparison. Abbreviations as in Figure 1.

FIGURE 3

All-Cause Mortality According to Presence and Severity of PPM Time-to-death curves for prosthesis-patient mismatch stratified in 2 groups (overall [i.e., moderate + severe] PPM vs. no-PPM) or in 3 groups (severe PPM, moderate PPM, no-PPM) for death from any cause in SAVR-RCT (A and B), TAVR-RCT (C and D), TAVR-NRCA (E and F), and TAVR-NRCA excluding patients with mild or greater total aortic regurgitation (G and H). For the panels B, D, F, E, the log-rank p values refer to the 3-group comparison. Abbreviations as in Figure 1.

FIGURE 3

All-Cause Mortality According to Presence and Severity of PPM Time-to-death curves for prosthesis-patient mismatch stratified in 2 groups (overall [i.e., moderate + severe] PPM vs. no-PPM) or in 3 groups (severe PPM, moderate PPM, no-PPM) for death from any cause in SAVR-RCT (A and B), TAVR-RCT (C and D), TAVR-NRCA (E and F), and TAVR-NRCA excluding patients with mild or greater total aortic regurgitation (G and H). For the panels B, D, F, E, the log-rank p values refer to the 3-group comparison. Abbreviations as in Figure 1.

FIGURE 3

All-Cause Mortality According to Presence and Severity of PPM Time-to-death curves for prosthesis-patient mismatch stratified in 2 groups (overall [i.e., moderate + severe] PPM vs. no-PPM) or in 3 groups (severe PPM, moderate PPM, no-PPM) for death from any cause in SAVR-RCT (A and B), TAVR-RCT (C and D), TAVR-NRCA (E and F), and TAVR-NRCA excluding patients with mild or greater total aortic regurgitation (G and H). For the panels B, D, F, E, the log-rank p values refer to the 3-group comparison. Abbreviations as in Figure 1.

FIGURE 3

All-Cause Mortality According to Presence and Severity of PPM Time-to-death curves for prosthesis-patient mismatch stratified in 2 groups (overall [i.e., moderate + severe] PPM vs. no-PPM) or in 3 groups (severe PPM, moderate PPM, no-PPM) for death from any cause in SAVR-RCT (A and B), TAVR-RCT (C and D), TAVR-NRCA (E and F), and TAVR-NRCA excluding patients with mild or greater total aortic regurgitation (G and H). For the panels B, D, F, E, the log-rank p values refer to the 3-group comparison. Abbreviations as in Figure 1.

FIGURE 3

All-Cause Mortality According to Presence and Severity of PPM Time-to-death curves for prosthesis-patient mismatch stratified in 2 groups (overall [i.e., moderate + severe] PPM vs. no-PPM) or in 3 groups (severe PPM, moderate PPM, no-PPM) for death from any cause in SAVR-RCT (A and B), TAVR-RCT (C and D), TAVR-NRCA (E and F), and TAVR-NRCA excluding patients with mild or greater total aortic regurgitation (G and H). For the panels B, D, F, E, the log-rank p values refer to the 3-group comparison. Abbreviations as in Figure 1.

FIGURE 3

All-Cause Mortality According to Presence and Severity of PPM Time-to-death curves for prosthesis-patient mismatch stratified in 2 groups (overall [i.e., moderate + severe] PPM vs. no-PPM) or in 3 groups (severe PPM, moderate PPM, no-PPM) for death from any cause in SAVR-RCT (A and B), TAVR-RCT (C and D), TAVR-NRCA (E and F), and TAVR-NRCA excluding patients with mild or greater total aortic regurgitation (G and H). For the panels B, D, F, E, the log-rank p values refer to the 3-group comparison. Abbreviations as in Figure 1.

CENTRAL ILLUSTRATION

Hemodynamic Sequelae Following Transcatheter or Surgical Aortic Valve Replacement In patients with severe AS and high surgical risk, PPM is less frequent and less often severe following TAVR than SAVR due to larger EOA for a given patient's annulus size; this hemodynamic sequel is associated with less LV mass regression and higher mortality. On the other hand, as shown in previous studies, PVR is much more frequent following TAVR than SAVR and it is associated with persistent LV hypertrophy and increased mortality. The hemodynamic benefit of TAVR over SAVR appears to be more important in the subset of patients with a small aortic annulus. AS = aortic stenosis; EOA = effective orifice area; LV = left ventricular; PPM = prosthesis-patient mismatch; PVR = paravalvular regurgitation; SAVR = surgical aortic valve replacement; TAVR: transcatheter aortic valve replacement.