Mitral valve-in-valve hemodynamic performance: An in vitro study

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Presentation transcript:

Mitral valve-in-valve hemodynamic performance: An in vitro study Morgane Evin, PhD, Carine Guivier-Curien, PhD, Regis Rieu, PhD, Josep Rodés-Cabau, MD, PhD, Philippe Pibarot, PhD The Journal of Thoracic and Cardiovascular Surgery Volume 151, Issue 4, Pages 1051-1059.e6 (April 2016) DOI: 10.1016/j.jtcvs.2015.11.039 Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 1 Effective orifice areas (EOAs) and mean transvalvular pressure gradient (mTPG) for the different valve and valve-in-valve configurations. Hemodynamic results of valve (left) and valve-in-valve configurations (right) are presented. The boundaries of the boxes represent the first and third quartiles, the black bar within the boxes represent the median value, the red bar within the box represents the mean value, and the black dashed lines and bars represent the minimum and maximum values. The red dashed line indicates an EOA of 1.0 cm2, which is the criteria for severe mitral stenosis in native valves16 and significant stenosis in mitral bioprosthetic valves.15 The black dashed line indicates an EOA of 1.5 cm2, which is considered as suggestive of moderate mitral stenosis.16 The blue dashed line indicates a mean mTPG of 5 mm Hg, which is the criteria for moderate mitral stenosis in native valves16 and significant stenosis in mitral bioprosthetic valves.15 SAP23, Sapien size 23 (Edwards Lifesciences, Irvine, Calif); SAP26, Sapien size 26 (Edwards Lifesciences).*P < .05 between groups. **P < .01 between groups ***P < .001 between groups. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 2 Regurgitant fraction (RF) for the different valve and valve-in-valve configurations. The dark green and light green dashed lines indicate RFs of 30% and 15%, which are the threshold for severe and moderate regurgitation, respectively. The boundaries of the boxes represent the first and third quartiles, the black bar within the boxes represent the median value, the red bar within the box represents the mean value, and the black dashed lines and bars represent the minimum and maximum values.15 SAP23, Sapien size 23 (Edwards Lifesciences, Irvine, Calif); SAP26, Sapien size 26 (Edwards Lifesciences). The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 3 Relationship between the hemodynamic parameters of the valve-in-valve configuration and the surgical bioprosthesis internal orifice diameter (IOD) and percentage of oversizing (%OS). Correlation between the IOD of the surgical bioprosthesis (see Table 1) and the (A) effective orifice area (EOA) and (B) regurgitant fraction (RF) with regression line (black line) and regression equation. Correlation between the valve-in-valve configuration %OS and the (C) EOA and (D) RF with regression line (black line) and regression equation. SAP23, Sapien size 23 (Edwards Lifesciences, Irvine, Calif); SAP26, Sapien size 26 (Edwards Lifesciences); SE, standard error. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 4 Comparison of the hemodynamic performance of valve-in-valve procedures with a Sapien 23 (SAP23) (Edwards Lifesciences, Irvine, Calif) versus a Sapien 26 (SAP26) (Edwards Lifesciences) in 4 surgical bioprostheses. Configurations of SAP23 (left) and SAP26 (right) deployed in each of the following surgical bioprostheses: St Jude Medical (27 and 29 mm; St Paul, Minn) and Mosaic (27 and 29 mm; Medtronic, Minneapolis, Minn). EOA, Effective orifice area; mTPG, mean transprosthetic pressure gradient; RF, regurgitant fraction. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure 5 Decision aids schema for SAPIEN (Edwards Lifesciences, Irvine, Calif) size choice for optimal valve-in-valve assembly hemodynamic results with IOD and percentage of oversizing thresholds for optimal choice of Sapien size for a failed mitral bioprosthesis. For Sapien 23, Sapien 20 could be considered for internal orifice diameter <21 mm and oversized >20% (red section on the left of the green bar for Sapien 23). Similarly, Sapien 29 could be considered for internal orifice diameter >25.3 and oversized <8% (red section on the right of the green bar for Sapien 26). The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure E1 Mock simulation system. In vitro system simulating both pulmonary and systemic circulation. Right ventricle (RV) is simulated by a gear pump, the fluid flows through the pulmonary valve (PV) (a Biocor 23 bioprosthesis; St. Jude Medical, St. Paul, Minn) and through compliances (C) and resistance (R) for pulmonary circulation simulation. Both left atrium (LA) and ventricle (LV) are anatomically simulated by silicone moulds immersed in closed cages in which pressure created by 2 Vivitro pumps (Vivitro Lab Inc., Victoria BS, Canada) enable contraction and dilation of the moulds. The aorta is simulated by a passive silicone mould and leads the water-glycerol fluid in the systemic circulation. Resistance in systemic circulation can be manually set to obtain wished mean aortic pressure. Validation of such a system is detailed elsewhere.12 AV, Aortic valve; MV, mitral valve. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure E2 Surgical bioprostheses and valve-in-valve assembly. (A) Epic (St Jude Medical, St Paul, Minn), (B) Mosaic Cinch (Medtronic, Minneapolis, Minn), and (C) Magna (Edwards, Irvine, CA). (D) Measurement of bioprosthesis internal orifice diameter by Smartscope optical system (OGP Multi Sensor Measuring Instruments, Singapore) showing outflow diameter and struts diameter. (E) Schema of an Epic 29 mm, a Sapien 23, and a valve-in-valve assembly. (F) Picture of a Sapien 23 deployed in a Medtronic Mosaic 29 mm bioprosthesis. IOD, Internal orifice diameter; d, upper diameter; D, basis diameter. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure E3 Receiver operating characteristic (ROC) curves for moderate prosthesis stenosis (effective orifice area [EOA] and mean transvalvular pressure gradient [mTPG]) and moderate regurgitation (regurgitant fraction [RF]). EOA, mTPG, and RF taken as dichotomous values with (A) EOA < 1 cm2 (green) and (B) mTPG > 5 mm Hg (red) for prediction of moderate stenosis and (C) RF > 30% (blue) for prediction of mild regurgitation. Both bioprosthesis internal orifice area and percent of Sapien oversizing covariates were considered as continuous variables. Dark-colored lines are prediction for Sapien 26 (Edwards Lifesciences, Irvine, Calif), pale-colored lines are prediction for Sapien 23 (Edwards Lifesciences). Dashed lines depict are prediction for both Sapien sizes. Of note, no mTPG was >5 mm Hg in the case of Sapien 26. IOD, Internal orifice diameter. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Figure E4 Percentage of configuration with significant mitral stenosis and significant mitral regurgitation, according to internal orifice diameter and percentage of oversizing thresholds. (Top) Percentage of the valve-in-valve configuration with significant mitral stenosis defined as effective orifice area < 1.5 cm2 for valve-in-valve in bioprosthesis with an internal orifice diameter (IOD) > 22.2 cm or IOD < 22.2 cm and with oversizing <20% and >20%. (Bottom) Percentage of the valve-in-valve configuration with significant mitral regurgitation defined as regurgitant fraction > 15% for valve-in-valve in bioprosthesis with an IOD < 22.8 cm for Sapien 23 (Edwards Lifesciences, Irvine, Calif), IOD < 23.5 cm for Sapien 26 (Edwards Lifesciences), or IOD > 22.8 cm for Sapien 23, IOD > 23.5 cm for Sapien 26, and with oversizing <8% and oversizing >8%. OS, Oversizing. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Effective orifice area. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Mean transvalvular pressure gradient. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Regurgitant fraction. The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions

Decision aids schema for SAPIEN (Edwards Lifesciences, Irvine, Calif) size choice for optimal valve-in-valve assembly hemodynamic results with IOD and percentage of oversizing thresholds for optimal choice of Sapien size for a failed mitral bioprosthesis. For Sapien 23, Sapien 20 could be considered for internal orifice diameter <21 mm and oversized >20% (red section on the left of the green bar for Sapien 23). Similarly, Sapien 29 could be considered for internal orifice diameter >25.3 and oversized <8% (red section on the right of the green bar for Sapien 26). The Journal of Thoracic and Cardiovascular Surgery 2016 151, 1051-1059.e6DOI: (10.1016/j.jtcvs.2015.11.039) Copyright © 2016 The American Association for Thoracic Surgery Terms and Conditions