Ex vivo evaluation of 3 different right ventricular outflow tract substitutes.

OBJECTIVES: The Ross procedure represents an excellent treatment option in younger patients with aortic stenosis but is limited by poor availability of homografts. In this study, we investigated the hydrodynamic performance of 3 different types of right ventricular outflow tract replacement with pericardium or synthetic material. METHODS: Three different types of valved conduits were constructed using pericardium and/or synthetic material (Group PEPE: pericardial cusps and pericardial conduit, Group PEPR: pericardial cusps and Dacron conduit, Group PRPR: expanded polytetrafluoroethylene cusps and Dacron conduit). The conduits were designed according to the Ozaki method. Their hydrodynamic performance (effective orifice area, mean pressure gradient and leakage volume) were evaluated in a mock circulation loop at different hydrodynamic conditions. RESULTS: Hydrodynamic assessment showed significantly larger effective orifice area of PEPE and PEPR compared to PRPR under all conditions and there were no significant differences between PEPE and PEPR [for condition 2: PEPE 2.43 (2.35-2.54) cm2, PEPR: 2.42 (2.4-2.5) cm2, PRPR: 2.08 (1.97-2.21) cm2, adjusted pairwise comparisons: PEPE versus PEPR: P = 0.80, PEPE versus PRPR: P < 0.001, PEPR versus PRPR: P < 0.001]. Mean pressure gradient was significantly lower for PEPE and PEPR compared with PRPR, whereas no significant differences were seen between PEPE and PEPR. Leakage volume was significantly lower for PEPE and PEPR compared with PRPR under all conditions while leakage was similar between PEPE and PEPR. CONCLUSIONS: Pulmonary graft reconstruction with pericardium cusps showed superior hydrodynamic performance compared with polytetrafluoroethylene cusps. Our results suggest that it could be considered as an alternative substitute for right ventricular outflow tract replacement during the Ross procedure.

Impact of different in vitro models on functional performance of the self-expanding transcatheter heart valve.

OBJECTIVES: Transcatheter heart valves (THVs) are investigated according to International Organization for Standardization requirements using in vitro heart simulators to evaluate hydrodynamic performance. In contrast to surgical valves, a THV's performance heavily depends on the configuration and shape of the aortic anulus. In International Organization for Standardization regulations, there is no detailed definition for the construction of a compartment in which a THV has to be tested. Therefore, the aim of this in vitro study was to compare different in vitro models for functional testing of THVs. METHODS: Porcine aortic conduits (23-mm diameter) were implanted in Dacron prostheses and calcified with double-distilled water and calcification buffer at 37°C over 83 million cycles in a Hi-Cycler (durability testing) mimicking nearly 3 patient-years. Hydrodynamic testing of Evolut PRO 26 mm was performed within 3 models (plexiglass, native conduit and calcified conduit; all 23-mm diameter) at a frequency of 64 bpm and different stroke volumes (55-105 ml). RESULTS: Calcified conduits showed significantly higher mean pressure gradients (MPG) and lower effective orifice areas (EOA) in comparison to native conduits (without THV; P < 0.001). EOA and MPG of Evolut PRO differed depending on the model tested. Calcified conduits resulted in the lowest EOA and highest MPG of the THV compared to plexiglass and the native conduit. Full expansion of the THV was least impaired in the native conduit, while lowest geometric orifice area, lowest minimal internal diameter and highest pin-wheeling index of Evolut PRO were seen in the calcified conduit. CONCLUSIONS: Full expansion and functional performance of the Evolut PRO THV depends on the configuration of the testing compartment in an in vitro setting.

Functional performance of 8 small surgical aortic valve bioprostheses: an in vitro study.

OBJECTIVES: Selection of a surgical aortic valve (SAV) bioprosthesis model for the treatment of aortic valve disease remains controversial. The aim of this study was to characterize the functional performance of 8 SAV models in a standardized in vitro setting. METHODS: The hydrodynamic performance of 8 SAVs with labelled size 21 mm (Avalus™, Hancock® II, Mosaic® Ultra™, Perimount®, Perimount® Magna Ease, Epic™ Supra, Trifecta™ GT; Freestyle®), was investigated in a pulse duplicator. Transvalvular pressure gradients and effective orifice area (EOA) were recorded. The geometrical orifice area and physical dimensions of the valves were determined, and new functional dimensions were introduced. RESULTS: Mean pressure gradient (MPG) and EOA differed significantly between the analysed SAVs. The Epic presented with the lowest EOA and highest MPG, while the Trifecta showed the highest EOA and the lowest MPG. We introduce a useful way to determine the minimal internal diameter and a new measure termed 'relative orifice area' to characterize a valve's performance. CONCLUSIONS: SAVs showed significant differences in their hydrodynamic performance despite the same label size. This finding was related to the construction of the valves. We introduce a new measure that characterizes the functional performance of a valve model and size for the treatment of an aortic annulus of a specific size. Our data emphasize that SAV selection should carefully be done using an individual patient approach and that future research is necessary to improve the current generation of SAVs.

Ex vivo evaluation of the Ozaki procedure in comparison with the native aortic valve and prosthetic valves.

OBJECTIVES: We investigated the hydrodynamic performance and cusp kinematics of the Ozaki neocuspidized aortic valve in comparison with the native aortic and prosthetic valves in an ex vivo study. METHODS: Native aortic valves of swine hearts were replaced by aortic valve substitutes, and their hydrodynamic performance (effective orifice area and mean pressure gradient) was evaluated in a mock circulation under defined conditions. The following aortic valve substitutes were investigated: native aortic valve, Ozaki valve, Perimount Magna Ease, Trifecta and St. Jude Medical Masters. All prosthetic valves had a labelled size of 21 mm. RESULTS: The Ozaki valve and native aortic valve showed a similar and significantly larger orifice area than all investigated prosthetic valves particularly at high flow rates. There was no significant difference between the Ozaki valve and the native aortic valve. The native aortic valve and Ozaki valve showed a similar increase in orifice area with increasing flow through the valve while prosthetic valves showed a markedly weaker increase. Similarly, the native and Ozaki valve showed a similar increase in mPG with forward flow which was weaker than prosthetic valves. Cusp kinematics were similar between the native and Ozaki valve, whilst prosthetic valves were clearly distinguishable from them. CONCLUSIONS: The Ozaki procedure showed excellent hydrodynamic performance compared to prosthetic valves and showed similar cusp motion characteristics to the native aortic valve. Our results suggest that the Ozaki neocuspidized valve behaves physiologically in many aspects, which may contribute to beneficial clinical outcomes.

The figure-of-8 aortic valve suturing technique optimizes the effective orifice area of a small aortic annulus-an ex vivo study.

OBJECTIVES: Surgical aortic valve replacement (SAVR) in small annuli carries an elevated risk for the patient-prosthesis mismatch. In this study, we systematically investigated the influence of different implantation techniques including annular enlargement (AE) on the functional result after SAVR in small annuli using a standardized ex vivo model. METHODS: SAVR using the PERIMOUNT Magna Ease® (PME) 21 mm was performed in small porcine aortic roots using 4 implantation techniques: non-everting pledgeted (NE) suture, single interrupted (SI) suture, continuous suture (CS), figure-of-8 (F8) suture, as well as the PME 23 mm after AE using the Nunez method and the NE suture technique (PME23 AE). The effective orifice area (EOA), mean pressure gradient and leakage volume were evaluated using a mock circulation loop in accordance with ISO regulations. RESULTS: Experiments were conducted on 31 porcine aortic roots. PME21 using F8 and PME23 after AE achieved a significantly larger EOA than using NE. PME23 after AE showed a larger EOA than the PME21 using any suture technique, except the F8 [for stroke volume of 74 ml: PME21 NE: 1.68 (1.63-1.72) cm2, PME21 SI: 1.76 (1.68-1.81) cm2 (P = 0.17), PME21 CS: 1.76 (1.65-1.79) cm2 (P = 0.14), PME21 F8: 1.81 (1.70-1.85) cm2 (P = 0.005); PME23 AE: 1.83 (1.73-1.92) cm2 (P < 0.001)]. SI and CS did not result in larger EOA compared with the NE technique. PME21 using SI had a significantly larger leakage volume than using NE and there was no significant difference between other techniques [for stroke volume of 74 ml: PME21 NE: 3.51 (1.85-4.53) ml/stroke, PME21 SI: 6.00 (4.02-7.06) ml/stroke (P < 0.001), PME21 CS: 4.04 (3.60-4.49) ml/stroke (P = 0.10), PME21 F8: 3.16 (1.99-3.62) ml/stroke (P = 0.74), PME23 NE: 2.89 (2.45-4.72) ml/stroke (P = 0.51)]. CONCLUSIONS: The F8 technique with the PME21 achieved a similar EOA as the 1 size larger PME23 using NE after AE. These results suggest that the F8 technique may be an effective surgical modification to improve the haemodynamic result in a small annulus without additional AE.

Impact of different valve-in-valve positions on the hydrodynamic performance of the newest-generation self-expanding transcatheter heart valve.

OBJECTIVES: Transcatheter aortic valve-in-valve (ViV) procedures are increasingly performed for the treatment of degenerated surgical aortic valves with a high risk for a redo operation. For an optimal functional result, precise positioning of the transcatheter heart valve (THV) inside the SHV is crucial. The aim of this study was to systematically investigate the impact of implantation depth on the functional result after a ViV procedure in a standardized in vitro setting. METHODS: A THV 23 mm (Evolut PRO) and 3 SHV 21 mm (Perimount Magna Ease, Trifecta and Hancock II) were used for hydrodynamic testing with a constant heartbeat 64/min and a range of 55-105 ml of stroke volume in 5 different positions of the THV. The following parameters were analysed: mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area, minimal internal diameter and pin-wheeling index. RESULTS: MPG and EOA differed significantly regarding the position of the THV in the same SHV. The highest EOA and the lowest MPG were recorded for Evolut PRO with significance for both parameters in Hancock II at 4 vs 5 mm (P < 0.001), in Magna Ease at 2 mm (vs 3 mm and vs 6 mm, P < 0.001) and in Trifecta at 4 mm (vs 5 and 6 mm, P < 0.001). Leaflet coadaptation, minimal internal diameter and maximal geometric orifice area of the same TAV differ regarding the position of the TAV. CONCLUSIONS: The optimal position for hydrodynamic performance of the THV as ViV differs among specific SHV models. The findings may be useful for planning a ViV procedure using the Evolut PRO THV.

Comprehensive analysis of haemodynamics in patients with physiologically curved prostheses of the ascending aorta.

OBJECTIVES: This is a comprehensive analysis of haemodynamics after valve-sparing aortic root replacement (VSARR) with anatomically curved prosthesis (CP) compared to straight prosthesis (SP) and age-matched volunteers (VOL) using 4D flow MRI (time-resolved three-dimensional magnetic resonance phase-contrast imaging). METHODS: Nine patients with 90° CP, nine patients with SP, and twelve VOL were examined with 4D flow MRI. Analyses included various characteristic anatomical, qualitative and quantitative haemodynamic parameters. RESULTS: Grading of secondary flow patterns was lower in CP patients than in SP patients (P = 0.09) and more comparable to VOL, albeit not reaching statistical significance. However, it was easy to differentiate between VSARR patients and healthy volunteers: Patients more often had angular aortic arches (CP: 89%, SP: 100%; VOL: 17%; P ≤ 0.002), increased average curvature (CP: 0.17/cm [0.15, 0.18]; SP: 0.15/cm [0.14, 0.16]; VOL: 0.14/cm [0.13, 0.16]; P ≤ 0.007; values given as median [interquartile range]), and more secondary flow patterns (CP: 3 [2, 4] SP: 3 [2, 3] VOL: 2 [1, 2]; P < 0.01). Maximum circulation (CP: 142.7 cm2/s [116.1, 187.3]; SP: 101.8 cm2/s [77.7, 132.5]; VOL: 42.8cm2/s [39.3, 65.6]; P ≤ 0.002), maximum helicity density (CP: 9.6 m/s2 [9.3, 23.9]; SP: 9.7 m/s2 [8.6, 12.5]; VOL 4.9 m/s2 [4.2, 7.7]; P ≤ 0.007), and wall shear stress gradient (e.g., proximal ascending aorta CP: 0.97 N/m2 [0.54, 1.07]; SP: 1.08 N/m2 [0.74, 1.24]; VOL: 0.41 N/m2 [0.32, 0.60]; P ≤ 0.01) were increased in patients. One CP patient had a round aortic arch with physiological haemodynamic parameters. CONCLUSIONS: The restoration of physiological aortic configuration and haemodynamics was not fully achieved with the curved prostheses in our study cohort. However, there was a tendency towards improved haemodynamic conditions in the patients with curved prostheses overall but without statistical significance. A single patient with a CP and near-physiological configuration of the thoracic aorta underlines the importance of optimizing postoperative geometric conditions for allowing for physiological haemodynamics and cardiovascular energetics after VSARR.

An ex vivo evaluation of two different suture techniques for the Ozaki aortic neocuspidization procedure.

OBJECTIVES: We investigated the Ozaki procedure using a single interrupted suture technique (SST) and compared this with the standard continuous suture technique (CST) with regard to hydrodynamic valve performance. In addition, both techniques were compared with the native aortic valve (NAV). METHODS: Effective orifice area, mean pressure gradient and leakage volume were evaluated in the NAV as well as after an Ozaki procedure using SST or CST in fresh swine aortic roots using a mock circulation loop. The NAV, SST and CST were evaluated under 4 defined hydrodynamic conditions. RESULTS: Both suture techniques resulted in a similar effective orifice area under all conditions [for stroke volume of 70 ml: SST: 1.50 (1.35-1.87) vs CST: 1.57 (1.41-1.72) cm2, P = 0.8] and there were no significant differences between both suture techniques and the NAV (P > 0.05). Regarding mean pressure gradient, the Ozaki procedure with SST and CST showed no significant differences [7.23 (5.53-8.91) vs 7.04 (6.65-7.60) mmHg, P = 0.72] and there was no significant difference between both suture techniques and the NAV (P > 0.1). In leakage volume, there was no significant difference between SST and CST [4.49 (3.91-4.99) vs CST: 4.23 (3.58-4.87) ml/stroke, P = 0.34]. CONCLUSIONS: The Ozaki procedure with SST performed similarly to that with CST with regard to hydrodynamic performance. Our results suggest that the Ozaki procedure can be performed with SST instead of CST, which may be useful in patients with limited surgical exposure, such as a small annulus.

Time-resolved 3-dimensional magnetic resonance phase contrast imaging (4D Flow MRI) reveals altered blood flow patterns in the ascending aorta of patients with valve-sparing aortic root replacement.

OBJECTIVE: The aim of this study was to compare aortic flow patterns in patients after David valve-sparing aortic root replacement with physiologically shaped sinus prostheses or conventional tube grafts in healthy volunteers. METHODS: Twelve patients with sinus prostheses (55 ± 15 years), 6 patients with tube grafts (58 ± 12 years), 12 age-matched, healthy volunteers (55 ± 6 years), and 6 young, healthy volunteers (25 ± 3 years) were examined with time-resolved 3-dimensional magnetic resonance phase contrast imaging (4D Flow MRI). Primary and secondary helical, as well as vortical flow patterns, were evaluated. Aortic arch anatomy as a flow influencing factor was determined. RESULTS: Compared with volunteers, both sinus prostheses and tube grafts developed more than 4 times as many secondary flow patterns in the ascending aorta (sinus prostheses n = 1.6 ± 0.8; tube grafts n = 1.3 ± 0.6; age-matched, healthy volunteers n = 0.3 ± 0.5; young, healthy volunteers n = 0; P ≤ .012) associated with a kinking of the prosthesis itself or at its distal anastomosis. As opposed to round aortic arches in volunteers (n = 16/18), cubic or gothic-shaped arches predominated in patients (n = 16/18, P < .001). In all but 3 volunteers, 2 counter-rotating helices were confirmed in the ascending aorta and were defined as a primary flow pattern. This primary flow pattern did not develop in patients who underwent valve-sparing aortic root replacement. CONCLUSIONS: In patients after valve-sparing aortic root replacement, there was an increased number of secondary flow patterns in the ascending aorta. This seems to be related to surgically altered aortic geometry with kinking. Because flow alterations are known to affect wall shear stress, there seems to be an increased risk for vessel wall remodeling. Compared with previous 4D Flow MRI studies, primary flow patterns in the ascending aorta in healthy subjects were confirmed to be more complex. This underlines the importance of thorough examination of 4D Flow MRI data.

In vitro 4D Flow MRI evaluation of aortic valve replacements reveals disturbed flow distal to biological but not to mechanical valves.

BACKGROUND AND AIM OF THE STUDY: Aortic hemodynamics influence the integrity of the vessel wall and cardiac afterload. The aim of this study was to compare hemodynamics distal to biological (BV) and mechanical aortic valve (MV) replacements by in vitro 4D Flow MRI excluding confounding factors of in-vivo testing potentially influencing hemodynamics. METHODS: Two BV (Perimount MagnaEase [Carpentier-Edwards], Trifecta [Abbott]) and two MV (On-X [CryoLife], prototype trileaflet valve) were scanned in a flexible aortic phantom at 3T using a recommended 4D Flow MR sequence. A triphasic aortic flow profile with blood-mimicking fluid was established. Using GTFlow (Gyrotools), area and velocity of the ejection jet were measured. Presence and extent of sinus vortices and secondary flow patterns were graded on a 0 to 3 scale. RESULTS: A narrow, accelerated central ejection jet (Area = 27 ± 7% of vessel area, Velocity = 166 ± 13 cm/s; measured at sinotubular junction) was observed in BV as compared to MV (Area = 53 ± 13%, Velocity = 109 ± 21 cm/s). As opposed to MV, the jet distal to BV impacted the outer curvature of the ascending aorta and resulted in large secondary flow patterns (BV: n = 4, grades 3, 3, 2, 1; MV: n = 1, grade 1). Sinus vortices only formed distal to MV. Although physiologically configured, they were larger than normal (grade 3). CONCLUSIONS: In contrast to mechanical valves, biological valve replacements induced accelerated and increased flow patterns deviating from physiological ones. While it remains speculative whether this increases the risk of aneurysm formation through wall shear stress changes, findings are contrasted by almost no secondary flow patterns and typical, near-physiological sinus vortex formation distal to mechanical valves.

A novel trileaflet mechanical heart valve: first in vitro results.

OBJECTIVES: Heart valve prostheses are the therapy of choice for patients with severe heart valve diseases. Two types of prostheses that can be implanted in patients are available: biological and mechanical. Though mechanical heart valves have some disadvantages like necessity of life-long anticoagulation, biological heart valve prostheses often necessitate reinterventions due to limited durability. Therefore, a new trileaflet mechanical heart valve was developed, featuring hinges in the systolic flow with the aim of function and thrombogenicity. METHODS: We first compared the new trileaflet mechanical heart valve to conventional bileaflet heart valves (St. Jude Medical and On-X valves) in vitro. Haemodynamic measurements were performed in a pulse duplicator system, and clot formation was examined with an implemented method using enzyme-activated milk as the test medium. RESULTS: Haemodynamic measurements showed the largest effective orifice areas and smallest pressure gradients for the trileaflet prosthesis compared to the bileaflet valve. Opening and closing characteristics of the trileaflet valve and of the St. Jude Medical valve were comparable. Clotting tests depicted only minor isolated deposits for the new trileaflet valve whereas the bileaflet valves showed distinct clots in the area of the hinge in all experiments. CONCLUSIONS: Haemodynamic and clotting tests showed improvements for the new trileaflet valve compared to common bileaflet valves. The off-wall systolic position of the hinges, which eluded adverse flow areas, was a major advantage of the new valve.

The influence of different inflow configurations on computational fluid dynamics in a novel three-leaflet mechanical heart valve prosthesis.

OBJECTIVES: A novel mechanical heart valve was developed with a special focus on avoiding anticoagulation. Computational fluid dynamics were used for the research design. Here, the effect of different anatomical inflow geometries on flow characteristics is evaluated. METHODS: Flow and pressure simulations were performed on a novel 3-leaflet mechanical heart valve in a fully open position at 2 flow rates related to the peak and end-systolic flow. The computational fluid dynamics model was designed according to 4 different (1 cylindrical, 3 conical with increasing diameter) anatomical configurations of the left ventricular outflow tract derived from an inverse heart model. RESULTS: With increasing inflow diameter, the flow velocity decreased for both flow rates, from 1543 mm/s in cylindrical configuration to 1475 mm/s in conical configuration for a flow rate of 18 l/min. However, there was no further decrease for the inflow diameters 38 and 48 mm. The velocity profile became broader with increasing inflow diameter and the maximal pressure decreased. At the leading edge, velocity almost stagnated, while the pressure increased and the reflection point moved downstream. No occurrence of dead space was observed with the different configurations and flow rates. CONCLUSIONS: An analysis of different anatomical inflow configurations by computational fluid dynamic simulations showed a more homogenous velocity profile and lower flow velocity values with increasing inflow diameter up to 38 mm in this novel 3-leaflet mechanical heart valve.

A matter of thrombosis: different thrombus-like formations in balloon-expandable transcatheter aortic valve prostheses.

OBJECTIVES: Transcatheter aortic valve implantation is a treatment strategy for degenerated aortic valve prostheses, but there is some concern regarding valve thrombosis. The optimal anticoagulation strategy for implantation of a transcatheter aortic valve prosthesis remains unclear. METHODS: Aortic root models with the Sapien-XT and S3 prostheses (sizes 23 and 26) fixed in a Perimount Magna Ease bioprosthesis (sizes 23 and 25) were constructed. The haemodynamics of the left ventricle were imitated in a proved in vitro model. Milk was used for coagulation after 90s. Different areas of the leaflets (W: wall coagulation, C: commissure coagulation left/right and S: sinus coagulation) were examined and the number of thrombus-like formations was counted. RESULTS: A total of 54% of the thrombus-like formations were found in the sinus, 28% at the wall area, 13% at the right commissure and 10% at the left commissure. Significant differences were detected at the wall area. S3 prostheses had significantly more thrombus-like formations than the XT prostheses. Additionally, in the S3 prostheses, the thrombus-like formation resembled a film whereas in the XT prostheses, the thrombus-like formation was like the crumbs of a cake. We noted exactly the same pattern in explanted prostheses from patients. CONCLUSIONS: The Sapien prostheses tend to form thromboses due to their flow properties. More than half of the thrombus-like formations were seen in the sinus. The S3 prostheses had significantly more thrombus-like formations than the XT prostheses in the wall area. There are different patterns of thrombus-like formations in XT and S3 prostheses used for transcatheter aortic valve implantation both in vivo and in vitro.

Ex vivo hydrodynamics after central and paracommissural edge-to-edge technique: A further step toward transcatheter tricuspid repair?

OBJECTIVES: Transcatheter approaches in heart valve disease became tremendously important and are currently established in the aortic position, but transcatheter tricuspid repair is still in its beginning and remains challenging. Replicating the surgical edge-to-edge technique, for example, with the MitraClip System (Abbott Vascular, Santa Clara, Calif), represents a promising option and has been reported successfully in small numbers of cases. However, up to now, few data considering the edge-to-edge technique as a transcatheter approach are available. This study aims to determine the ex vivo hydrodynamics after the central and paracommissural edge-to-edge technique in different pathologies. METHODS: Because of basal or apical dislocation of papillary muscles, leaflet prolapse or tethering was simulated in porcine tricuspid valves mounted on a flexible holding device. Central and paracommissural edge-to-edge techniques were evaluated successively in these pathologies. Regurgitant volume and mean transvalvular gradient were determined in a pulse duplicator. RESULTS: In this ex vivo model, the isolated edge-to-edge technique reduced tricuspid regurgitation. In the prolapse model, regurgitant volume decreased significantly after central edge-to-edge technique (from 49.4 ± 13.6 mL/stroke to 39.3 ± 14.1 mL/stroke). In the tethering model, both the central and the paracommissural edge-to-edge techniques led to a significant decrease (from 48.7 ± 13.9 to 43.6 ± 15.6 and to 41.1 ± 13.8 mL/stroke). In all cases, the reduction of regurgitant volume was achieved at the cost of significantly increased mean transvalvular gradient. CONCLUSIONS: This study provides a reduction of tricuspid regurgitation after the edge-to-edge technique in the specific experimental setup. Whether this reduction is sufficient to treat tricuspid regurgitation successfully in clinical practice remains to be established. Transcatheter approaches need to be evaluated further, probably with regard to concomitant annuloplasty for higher reduction of tricuspid regurgitation.

Mitral valve replacement with the novel TRIBIO and an established stented bioprosthesis in a sheep model.

OBJECTIVES: Heart valve replacement with a bioprosthesis is one of the most frequently performed procedures in cardiac surgery and represents a highly effective therapy to relieve diseased heart valves. Nevertheless, as postoperatively elevated transvalvular gradients and prosthesis-patient mismatch are reported as shortcomings of the procedure or of the currently used devices, there is a need for novel bioprostheses with improved haemodynamics. This study presents preclinical haemodynamic results after mitral valve replacement with the novel TRIBIO bioprosthesis (TRIBIO) compared with an established bioprosthesis in a sheep model. METHODS: Six female sheep had their mitral valves replaced with the TRIBIO and 3 with the Carpentier-Edwards Perimount, both sized 19 mm. The TRIBIO consists of a flexible valve-bearing crown, a force-decoupled interface and an intra-annular base ring. Mean and peak transvalvular gradients as well as an effective orifice area were monitored in both groups using transthoracic echocardiography over the course of the 90-day study. RESULTS: In both groups, haemodynamic performance diminished over time. The TRIBIO demonstrated overall superior haemodynamics, i.e. lower transvalvular gradients and a larger effective orifice area, although the results were not statistically significant. On Day 90, the mean values for the mean and peak transvalvular gradients and the effective orifice area were 6 mmHg, 10.2 mmHg and 1.2 cm2 for the TRIBIO and 10 mmHg, 15.8 mmHg and 0.8 cm2 for the Carpentier-Edwards Perimount, respectively. CONCLUSIONS: This study demonstrates a trend towards improved preclinical haemodynamic performance following mitral valve replacement with the TRIBIO compared to that with an established bioprosthesis in a sheep model.

First ex vivo and preliminary sheep model results of the new TRIBIO aortic valve bioprosthesis in small aortic annuli.

OBJECTIVES: Small aortic annuli are challenging in aortic valve replacement. Prosthesis-patient mismatch, accompanied by high transvalvular gradients and small orifice area, is an often faced problem impairing postoperative outcome. The new TRIBIO bioprosthesis aims to enable enhanced haemodynamics, being increasingly important with decreasing annular size. This study compares ex vivo hydrodynamics of TRIBIO with 2 established bioprostheses in small annuli at different stroke volumes, simulating 'rest' and 'exercise', and evaluates haemodynamics of TRIBIO in a sheep model. METHODS: Ex vivo: Porcine aortic roots were hardened with glutaraldehyde, approaching the stiffness of decalcified roots. Each bioprosthesis (TRIBIO, Trifecta™, Perimount® Magna Ease), size 19 mm, was implanted in each aortic root and inserted into a pulse duplicator, determining hydrodynamics and geometric orifice area at different stroke volumes (74, 90, 104 ml). Sheep model: Postoperative transvalvular gradients were assessed after implantation of 19 mm TRIBIO in aortic position. RESULTS: Ex vivo: Mean transvalvular gradients were lowest in TRIBIO (7.3, 8.7, 10.2 mmHg at 74, 90, 104 ml) with significant difference to Perimount® Magna Ease. Geometric orifice area in TRIBIO was 2.7 cm2 and significantly larger compared to Perimount® Magna Ease and Trifecta™. Opening of TRIBIO was uniform and apparently complete, whereas leaflet's outward movement was restricted particularly in Perimount® Magna Ease. Sheep model: TRIBIO presented with low transvalvular gradients (δpmean 4.1 ± 2 mmHg, δpmax 7.8 ± 4.6 mmHg), unimpaired leaflet motion and no central or paravalvular leakage. CONCLUSIONS: Ex vivo, the TRIBIO achieved superior hydrodynamics compared to latest generation bioprostheses. These excellent data are supported by very low transvalvular gradients in a preliminary sheep model.

In vitro coronary flow after transcatheter aortic valve-in-valve implantation: A comparison of 2 valves.

BACKGROUND: Transcatheter aortic valve-in-valve implantation (TAVI-ViV) is an evolving treatment strategy for degenerated surgical aortic valve bioprostheses (SAVBs). However, there is some concern regarding coronary obstruction, especially after TAVI-ViV in calcified SAVBs with externally mounted leaflets. We investigated in vitro coronary flow and hydrodynamics after TAVI-ViV using 2 modern SAVBs with externally and internally mounted leaflets. METHODS: Aortic root models including known risk factors for coronary obstruction served for the implantation of SAVBs with either externally mounted leaflets (St Jude Trifecta, size 25) or internally mounted leaflets (Edwards Perimount Magna Ease, size 25). Left and right coronary flow, as well as hydrodynamic parameters, were measured before and after TAVI-ViV with an Edwards Sapien XT transcatheter heart valve, size 23. After the first experimental run, the SAVB leaflets were artificially "calcified," and the measurements were repeated. RESULTS: In both models, noncalcified and calcified, there was no significant reduction in coronary flow with either the Trifecta or the Perimount Magna Ease SAVB. After TAVI-ViV, in the noncalcified model, the mean pressure gradient was increased (Trifecta, P = .0001; Perimount Magna Ease, P = .006) and the geometric orifice area was decreased (P < .001 for both), whereas in the calcified model, the mean pressure gradient was decreased (P < .001 for both) and the geometric orifice area was increased (P < .001 for both). CONCLUSIONS: In our specific model, in noncalcified as well as calcified conditions, TAVI-ViV is feasible with either SAVB (Trifecta or Perimount Magna Ease) without an increased risk of coronary obstruction. Nevertheless, before clinical application of these results, thorough preoperative assessment, considering the different limitations of this model, is mandatory.

Time-resolved 3-dimensional magnetic resonance phase contrast imaging (4D Flow MRI) analysis of hemodynamics in valve-sparing aortic root repair with an anatomically shaped sinus prosthesis.

OBJECTIVE: The anatomically shaped sinus prosthesis (Uni-Graft W SINUS; Braun, Melsungen, Germany) used in valve-sparing aortic root replacement promises physiological hemodynamics believed to grant physiologic valve function. Using time-resolved 3-dimensional magnetic resonance phase contrast imaging (4D Flow MRI), we analyzed sinus vortex formation and transvalvular pressure gradients in patients with sinus prosthesis compared with age-matched and young healthy volunteers. METHODS: Twelve patients with sinus prosthesis (55 ± 15 years), 12 age-matched and 6 young healthy volunteers (55 ± 6 years, 25 ± 3 years, respectively) were examined at 3T with a 4D flow magnetic resonance imaging sequence. Sinus vortices visualized by streamlines and time-resolved particle paths were graded on a 4-point Likert scale. Time resolved pressure differences of the left ventricular outflow tract and the ascending aorta to a reference point in the aortic bulb as well as the transvalvular pressure gradient were evaluated. RESULTS: 4D flow visualizations revealed a propensity of the sinus prosthesis toward intermediate (50%) and large (28%) vortices compared with age-matched volunteers with small (61%) and intermediate (36%) vortices. Vortices in sinus prostheses had a similar configuration compared with those in volunteers. The peak transvalvular pressure gradient did not vary significantly between patients and age-matched volunteers (4.0 ± 0.9 mm Hg, 3.8 ± 0.7 mm Hg, P = .373), its temporal evolution resembled that of volunteers with a prolonged positive phase in patients. CONCLUSIONS: Hemodynamics closely relating to those of volunteers were confirmed in sinus prostheses, believed to grant physiological valve function. Minor differences are presumably attributed to graft compliance and temporal resolution of the acquisition. Nevertheless, long-term deterioration of valve function as it was described for straight grafts could potentially be decelerated using sinus prostheses.