Prosthesis-Patient Mismatch after Transcatheter Aortic Valve Implantation Using the Edwards SAPIEN™ Prosthesis.
ABSTRACT Objectives Prosthesis-patient mismatch (PPM) is defined as a too small effective orifice area (EOA) of the prosthetic valve in relation to the patient's body size and has been documented to be related to adverse outcomes after conventional aortic valve replacement (AVR). Aim of this study was to analyze the incidence of PPM after transcatheter aortic valve implantation (T-AVI) using the Edwards SAPIEN prosthesis and its relation to postoperative outcome.Methods 200 consecutive high-risk patients underwent transapical aortic valve implantation (TA-AVI) between February 2006 and January 2009 and fulfilled 1 year follow-up were included. Severe PPM was defined as indexed EOA (EOAi) <0.65cm2/m2 and moderate PPM as EOAi = 0.65-0.85 cm2/m2, EOA was calculated from transthoracic echocardiographic (TTE) measurements using the continuity equation. Total 112 patients with sufficient postoperative TTE image quality formed the study group.Results EOAi increased from 0.3 ± 0.1 cm2/m2 (preoperatively) to 1.1 ± 0.4 cm2/m2 after TA-AVI (p < 0.001). According to the standard definitions, PPM was seen in 38.4% of the patients and 9.8% presented with severe PPM. The occurrence of PPM had neither an effect on clinical outcome in terms of NYHA class nor on survival. Patients with PPM had significantly higher postoperative transprosthetic gradients (mean gradient 10.4 ± 4.1 versus 7.1 ± 3.0 mm Hg, p < 0.001). Based on the in-vitro EOA data obtained from pulse duplicator measurements, however, none of the patients was judged to have PPM.Conclusion Transcatheter AVI provides good antegrade hemodynamic function and EOAi improves significantly. According to standardized evaluations PPM occurs after TA-AVI, but it is not associated with adverse outcomes. Thus use of the continuity equation may not adequately reflect the situation after T-AVI or the current definition of PPM is not suitable for T-AVI prostheses.
- Journal of cardiothoracic and vascular anesthesia 03/2014; · 1.06 Impact Factor
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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 cm2/m2, moderate if the indexed EOA was ≥0.65 but ≤0.85 cm2/m2, or severe if the indexed EOA was <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 = 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)Journal of the American College of Cardiology 09/2014; 64(13):1323–1334. · 15.34 Impact Factor
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ABSTRACT: Background Patient-prosthesis mismatch (PPM) has been reported with a wide range of bioprosthetic valves after aortic valve replacement (AVR) and has been associated with multiple adverse outcomes. The aim of this study was to test the hypothesis that a novel low-profile stented pericardial tissue bioprosthesis for AVR, the Trifecta aortic valve, would have superior hemodynamics, a lower incidence of PPM, and an improvement in clinical outcomes. Its hemodynamic performance was evaluated, and a comparison was performed with a traditional stented pericardial bioprosthesis (Epic) with respect to hemodynamics, PPM, and clinical events. Methods One hundred twenty-four patients (mean age, 73.6 ± 11.0 years) underwent AVR. Prosthetic valve types used were Trifecta (n = 75 [60.5%]) and Epic (n = 49 [39.5%]). Intraoperative transesophageal echocardiography was used to evaluate hemodynamic variables before and after AVR. Results Postoperative comparison of the Epic valve and the Trifecta valve revealed a lower mean pressure gradient (16.5 ± 6.7 vs 8.8 ± 3.4 mm Hg, P < .001), a lower peak gradient (33.3 ± 11.8 vs 19.4 ± 8.6 mm Hg, P < .001), and higher indexed effective orifice area (0.8 ± 0.2 vs 1.1 ± 0.4 cm2/m2, P < .001), favoring the Trifecta valve across several valve sizes. Severe PPM (6% vs 27%, P < .001) and valvular-related complications at follow-up (14.3% vs 36.7%, P = .005) were less frequent in the Trifecta group. Conclusions The hemodynamic performance of the Trifecta valve is superior to that of the Epic valve across many conventional prosthesis sizes, and its implantation resulted in lower rates of severe PPM. These improvements were associated with lower valvular-related adverse events.Journal of the American Society of Echocardiography: official publication of the American Society of Echocardiography 01/2014; · 2.98 Impact Factor