Prosthesis-Patient Mismatch after Transcatheter Aortic Valve Implantation Using the Edwards SAPIEN™ Prosthesis.

Department of Cardiac Surgery, Heartcenter University of Leipzig, Germany.
The Thoracic and Cardiovascular Surgeon (Impact Factor: 0.93). 07/2012; DOI: 10.1055/s-0032-1311534
Source: PubMed

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.

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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.
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    ABSTRACT: Transcatheter aortic valve implantation with the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN (ES) bioprostheses has been widely used for the treatment of severe aortic stenosis. However, a direct comparison of the hemodynamic results associated with these 2 prostheses is lacking. The aim of the present study was to compare the hemodynamic performance of both bioprostheses. A total of 41 patients who underwent transcatheter aortic valve implantation with the CV prosthesis were matched 1:1 for prosthesis size (26 mm), aortic annulus size, left ventricular ejection fraction, body surface area, and body mass index with patients who underwent transcatheter aortic valve implantation with the ES prosthesis. Doppler-echocardiographic data were prospectively collected before the intervention and at hospital discharge, and all examinations were sent to, and analyzed in, a central echocardiography core laboratory. The mean transprosthetic residual gradient was lower (p = 0.024) in the CV group (7.9 ± 3.1 mm Hg) than in the ES group (9.7 ± 3.8 mm Hg). The effective orifice area tended to be greater in the CV group (1.58 ± 0.31 cm(2) vs 1.49 ± 0.24 cm(2), p = 0.10). The incidence of severe prosthesis-patient mismatch was, however, similar between the 2 groups (effective orifice area indexed to the body surface area ≤0.65 cm(2)/m(2); CV 9.8%, ES 9.8%, p = 1.0). The incidence of paravalvular aortic regurgitation was greater with the CV (grade 1 or more in 85.4%, grade 2 or more in 39%) than with the ES (grade 1 or more in 58.5%, grade 2 or more in 22%; p = 0.001). The number and extent of paravalvular leaks were greater in the CV group (p <0.01 for both comparisons). In conclusion, transcatheter aortic valve implantation with the CV prosthesis was associated with a lower residual gradient but a greater rate of paravalvular aortic regurgitation compared to the ES prosthesis. The potential clinical consequences of the differences in hemodynamic performance between these transcatheter heart valves needs to be addressed in future studies.
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