CarboMedics Research Articles

A Numerical Investigation of Blood Damage in the Hinge Area of Aortic Bileaflet Mechanical Heart Valves During the Leakage Phase

Previous experimental and numerical blood studies have shown that high shear stress levels, long exposure times to these shear stresses, and flow recirculation promote thromboembolism. Artificial heart valves, in particular bileaflet mechanical heart valves (BMHVs), are prone to developing thromboembolic complications. These complications often form at the hinge regions of BMHVs and the associated geometry has been shown to affect the local flow dynamics and the associated thrombus formation. However, to date no study has focused on simulating the motion of realistically modeled blood elements within the hinge region to numerically estimate the hinge-related blood damage. Consequently, this study aims at (a) simulating the motion of realistically modeled platelets during the leakage (mid-diastole) phase in different BMHV hinge designs placed in the aortic position and (b) quantitatively comparing the blood damage associated with different designs. Three designs are investigated to assess the effects of hinge geometry and dimensions: a 23 mm St. Jude Medical Regent™ valve hinge with two different gap distances between the leaflet ear and hinge recess; and a 23 mm CarboMedics (CM) aortic valve hinge. The recently developed lattice-Boltzmann method with external boundary force method is used to simulate the hinge flow and capture the dynamics and surface shear stresses of individual platelets. A blood damage index (BDI) value is then estimated based on a linear shear stress-exposure time BDI model. The velocity boundary conditions are obtained from previous 3D large-scale simulations of the hinge flow fields. The trajectories of the blood elements in the hinge region are found to be qualitatively similar for all three hinges, but the shear stresses experienced by individual platelets are higher for the CM hinge design, leading to a higher BDI. The results of this study are also shown to be in good agreement with previous studies, thus validating the numerical method for future research in BMHV flows. This study provides a general numerical tool to optimize the hinge design based on both hemodynamic and thromboembolic performance.

Comprehensive Hemodynamic Assessment of 305 Normal CarboMedics Mitral Valve Prostheses Based on Early Postimplantation Echocardiographic Studies

Two-dimensional (2D) and Doppler-derived echocardiographic data on normal CarboMedics (CM) mechanical mitral valve prosthesis function have been reported but are limited. Comprehensive retrospective 2D and Doppler echocardiographic assessment of 305 normal CM mechanical mitral valve prostheses (272 Standard and 33 Optiform) was performed early after implantation. The early postimplantation hemodynamic profiles of 80 patients were compared with profiles obtained by follow-up transthoracic echocardiography performed <1 year after implantation. CM Standard and Optiform prostheses had similar hemodynamic profiles. With mean ± 2 SDs used to define the normal distribution of values for hemodynamic variables, the calculated normal range of values was as follows: mean gradient, 2 to 7 mm Hg; peak early mitral diastolic velocity, 1.3 to 2.4 m/sec; time-velocity integral (TVI) of the mitral valve prosthesis (TVI(MVP)), 20 to 50 cm; ratio of TVI(MVP) to the TVI of the left ventricular outflow tract, 0.9 to 2.5; pressure half-time, 35 to 99 msec; and effective orifice area, 1.17 to 3.25 cm(2). Patients with severe prosthesis-patient mismatch (indexed effective orifice area ≤ 0.9 cm(2)/m(2)) had significantly higher mean gradients, peak early mitral diastolic velocities, TVI(MVP), ratios of TVI(MVP) to the TVI of the left ventricular outflow tract, and pressure half-time values than values without severe prosthesis-patient mismatch, but none had pressure half-time values > 120 msec. Among the 80 patients with follow-up transthoracic echocardiography within 1 year after implantation, no significant differences were noted between early postimplantation findings and follow-up hemodynamic profiles. This study establishes parameters (mean ± 2 SD) defining the distribution of findings for Doppler-derived hemodynamic data with normal CM mechanical mitral valve prostheses. Prostheses with hemodynamic values outside these parameters are likely dysfunctional; however, prosthesis dysfunction may be present even when hemodynamic values are within these ranges.

Multidetector CT imaging of mechanical prosthetic heart valves: quantification of artifacts with a pulsatile in-vitro model

ObjectivesMultidetector computed tomography (MDCT) can detect the cause of prosthetic heart valve (PHV) dysfunction but is hampered by valve-induced artifacts. We quantified artifacts of four PHV using a pulsatile in-vitro model and assessed the relation to leaflet motion and valve design.MethodsA Medtronic Hall tilting disc (MH), and Carbomedics (CM), St Jude (SJM), and ON-X bileaflet valves underwent CT in an in-vitro model using retrospective gating with a 64 detector CT system in stationary and pulsatile conditions. Artifacts and radiopaque component volumes were quantified with thresholds based on surrounding structures and valvular components.ResultsHypodense artifacts volumes (mm3) were 1,029 ± 147, 535 ± 53, 371 ± 16, and 366 ± 18 for the SJM, MH, CM and ON-X valves (p < 0.001 except for the latter two valves p = 0.43). Hyperdense artifact volumes were 3,546 ± 141, 2,387 ± 103, 2,003 ± 102, and 3,033 ± 31 for the SJM, MH, CM and ON-X valve, respectively (all differences p < 0.001). Leaflet motion affected hypodense (F = 41.5, p < 0.001) and hyperdense artifacts (F = 53.7, p < 0.001). Closed and moving leaflets were associated with the least and the most artifacts respectively (p < 0.001, both artifact types).ConclusionBoth valve design and leaflet motion affect PHV-induced artifacts. Best imaging results may be expected for the CM valve during phases in which the leaflets are closed.

The 12cc Penn State Pulsatile Pediatric Ventricular Assist Device: Fluid Dynamics Associated With Valve Selection

The mortality rate for infants awaiting a heart transplant is 40% because of the extremely limited number of donor organs. Ventricular assist devices (VADs), a common bridge-to-transplant solution in adults, are becoming a viable option for pediatric patients. A major obstacle faced by VAD designers is thromboembolism. Previous studies have shown that the interrelated flow characteristics necessary for the prevention of thrombosis in a pulsatile VAD are a strong inlet jet, a late diastolic recirculating flow, and a wall shear rate greater than 500 s(-1). Particle image velocimetry was used to compare the flow fields in the chamber of the 12 cc Penn State pediatric pulsatile VAD using two mechanical heart valves: Bjork-Shiley monostrut (BSM) tilting disk valves and CarboMedics (CM) bileaflet valves. In conjunction with the flow evaluation, wall shear data were calculated and analyzed to help quantify wall washing. The major orifice inlet jet of the device containing BSM valves was more intense, which led to better recirculation and wall washing than the three jets produced by the CM valves. Regurgitation through the CM valve served as a significant hindrance to the development of the rotational flow.

Severe Subaortic Stenosis

Severe Subaortic Stenosis

Bileaflet mechanical valve sound analysis using a continuous wavelet transform

Bileaflet mechanical valve closing sounds have splits, the duration of which is not constant in normally functioning valves. However, no reports have discussed the influences of valve malfunction on the split interval, neither have any studies discussed the fact that mechanical valve closing sound signals must be analyzed using a time-frequency analysis because they are nonstationary signals. The continuous wavelet transform (CWT), a time-frequency analyzing method using mother wavelets modified by scale numbers, was selected in this study for analyzing bileaflet valve closing sounds because it is easy to understand and has no limitations such as the cross-terms in the Wigner-Ville distribution or the tradeoff between time and frequency resolutions of the short-time Fourier transform. This study compares the properties of the mother wavelets of various CWTs and selects one that is suitable for detection of the clear split in bileaflet mechanical valve closing sound signals. This article also establishes a standard frequency analyzing system for bileaflet mechanical valve sounds. A preliminary study with chirp Doppler signals for comparing the frequency properties of the mother wavelets of various CWTs suggested that Ishikawa's modified Morlet CWT has better time and frequency resolution at the highest frequency scale. Morlet/power CWT analysis of normal in vivo bileaflet valve closing sounds of the ST. Jude Medical (SJM), ATS, and Carbomedics (CM) valves demonstrated clear splits of very short interval at the highest level of frequency. Detection of the disappearance of the split by using this analytical method may be the key to identifying bileaflet mechanical valve malfunction in outpatient departments.

Surgical considerations in the correction of valve dysfunction following heart transplantation

Valve dysfunction is not an uncommon occurrence following heart transplantation but when present can be managed medically with diuretics and vasodilator therapy. If medical therapy fails, these patients are considered for retransplantation. Due to the scarcity of donor hearts, efforts aimed at limiting the pool of cardiac retransplantation candidates are being focused lately on preservation of cardiac allograft function by conventional operations in lieu of a retransplant. A review of the literature for patients who underwent valve operations following their heart transplants yielded 26 cases. Four of these had isolated mitral valve procedures, 18 had tricuspid procedures, two had combined mitral and tricuspid operations and two had aortic valve replacements. In this communication, we present a case of severe aortic insufficiency developing 7 yr after heart transplantation and leading to progressive clinical deterioration and NYHA class IV heart failure symptoms. The aortic valve was replaced with a 21-mm Carbo Medics supra-annular mechanical prosthesis (CarboMedics Inc.). She had a favorable postoperative course and remains well 7 months after her operation. Surgical correction of valvular lesions is warranted if the function of the previously transplanted heart is reasonably preserved.

Comparison of the Hinge Flow Fields of Two Bileaflet Mechanical Heart Valves under Aortic and Mitral Conditions

Animal and clinical studies have shown that bileaflet mechanical heart valve designs are plagued by thromboembolic complications, with higher rates in the mitral than in the aortic position. This study evaluated the hinge flow dynamic of the 23 mm St. Jude Medical (SJM) Regent and the 23 mm CarboMedics (CM) valves under aortic conditions and compared these results with previous findings under mitral conditions. Velocity and Reynolds shear stress fields were captured using two-component laser Doppler velocimetry. Under aortic conditions, both the SJM and CM hinge flow fields exhibited a strong forward flow pattern during systole (maximum velocities of 2.31 and 1.75 m/s, respectively) and two main leakage jets during diastole (maximum velocities of 3.08 and 2.27 m/s, respectively). Aortic and mitral flow patterns within the two hinges were similar, but with a more dynamic flow during the forward flow phase under aortic conditions. Velocity magnitudes and shear stresses measured under mitral conditions were generally higher than those obtained in the aortic position, which may explain the higher rates of thromboembolism in the mitral implants when compared with the aortic implants.

Long-term results with triple valve surgery

Background. Whether to use biological or mechanical prostheses and whether to repair or replace the tricuspid valve during primary and reoperative triple valve surgery remains controversial. The objective of the present study was to review our experience with primary and reoperative triple valve surgery using CarboMedics (CM) and Carpentier-Edwards (C-E) heart valves. Methods. All 73 patients undergoing triple valve surgery since 1982 were prospectively followed at the Montreal Heart Institute valve clinic. Aortic valve replacement was performed with CM prostheses (57 patients) and with C-E prostheses (16 patients). Mitral valve replacement was performed with mechanical prostheses (56 patients) and with biological valves (14 patients). Mitral valve repair was done in 3 patients. Tricuspid valve annuloplasty or commissurotomy or both were performed in 66 patients and the tricuspid valve was replaced in 7 patients. Patient survival, complications, and the type of valve procedures were analyzed. Results. Thirty patients averaging 62 ± 10 years of age underwent primary triple valve surgery and 43 patients averaging 60 ± 10 years of age underwent reoperative triple valve surgery ( p = 0.5). Tricuspid repair consisted of annuloplasty with the Bex linear reducer (n = 47), the C-E ring (n = 13), or the De Vega technique (n = 5). Tricuspid valve replacement was done using the C-E pericardial prostheses. The 30-day mortality was 17% and 12% in patients with primary and reoperative surgery, respectively ( p = 0.5) and patient survival averaged 80% ± 7%, 75% ± 8%, and 41% ± 15%, and 70% ± 7%, 57% ± 9%, and 50% ± 10%, respectively 1, 5, and 10 years following surgery ( p = 0.5). The freedom rate from thromboembolism and from bleeding complications were 87% ± 6% and 95% ± 3% in primary and reoperative patients, respectively, 5 years following surgery. Conclusions. Triple valve surgery, either as a primary or a reoperative procedure, results in acceptable long-term survival with both mechanical and biological prostheses.

Influence of valve size on the hydrodynamic performance of the ATS valve

Cineradiography has revealed the presence of the “non-fully-open” phenomenon in patients with the ATS valve. Preliminary in vitro investigations have identified two contributing factors: the expanding space at the outlet of the valve, and the local flow in the pivot area. This further study was performed with the aim of elucidating these factors with respect to different sizes of the ATS valve. Three bileafet valves, ATS, CarboMedics (CM), and St. Jude Medical (SJM), with tissue annulus diameters of 25 and 29 mm, were studied. The hydrodynamic performance of the valves was tested at the mitral position of our own pulse duplicator. The opening angle was measured using a high-speed video camera. All the CM and SJM valves were able to open fully in these tests, whereas the 25-mm and 29-mm ATS valves opened to 75° and 82°, respectively, despite their design maximum of 85°. The ATS exhibited the smallest pressure drop of the 29-mm valves, and the SJM the smallest of the 25-mm valves. The incomplete opening of the ATS valve might be explained by the ability of its leaflets to align themselves with the divergent outlet flow, due to its unique open-pivot design. Such a feature would also exhibit a low pressure drop, as seen in the 29-mm valve. The smaller opening angle in the 25-mm valve, however, could be caused by the additional pivot-flow, which might cause greater deviation of the leaflets in the smaller valve, resulting in a higher relative pressure drop.

Flow analysis of the bileaflet mechanical prosthetic heart valves using laser Doppler anemometer: Effect of the valve designs and installed orientations to the flow inside the simulated left ventricle

Ever since the first introduction of the ball-type valve by Hufnagel in 1952, which was installed in the descending aorta to correct aortic valve insufficiency, great efforts have been aimed to produce a hemodynamically and structurally superior prosthetic heart valve. Bileaflet valves, commercially initiated by the St. Jude medical (SJM) valve, perform satisfactorily, and now the majority of the mechanical-type prosthetic heart valves used clinically are of this type. The recent trend in bileaflet valve design seems to be concentrated on the hinge mechanism and leaflet design to improve performance against thromboembolic complications and hemolysis. This paper studied the effects of hinge location, leaflet configuration, valve opening angle, and valve installed orientation to the flow field inside the simulated ventricle using laser Doppler anemometry. As a model prosthetic valve, the SJM valve was selected as a reference, and newer bileaflet valves, including the ATS, the Carbomedics (CM), and the Jyros (JR) valves, were selected for comparison. The test program also utilized a flow visualization technique to map the velocity field inside the simulated ventricle to complement the information obtained using the LDA system. Comparison of the velocity profiles at corresponding flow phases revealed the effects of the differences in valve design and orientation. Based on precise examination of the data, the following general conclusions can be made: all valves (SJM, ATS, CM, and JR) show distinct circulatory flow patterns when the valve is installed in the antianatomical orientation. The small differences in hinge location and leaflet configuration can generate noticeable differences, particularly during the accelerating flow phase of the valve. The ATS and the CM valves open less during the forward flow phase, and this results in generally diverse and less distinct flow patterns and slower velocity. This is particularly noticeable for the flow through the central orifice. The SJM valve maintains a relatively higher velocity through the central orifice. The curved leaflet JR valve generates higher but divergent flow during the accelerating and peak flow phases.

Effect of the mechanical prosthetic mono- and bileaflet heart valve orientation on the flow field inside the simulated ventricle

Two groups of typical contemporary mechanical heart valves, the Advancing the Standard (ATS) and the Carbomedics (CM) valve (of bileaflet design) and the Bjork-Shiley (BS) mono and Bicer-Val (BV) valves (of tilting-disc design), were tested in the mitral position under the pulsatile-flow condition. This study extends a previous report studying the effect of orientation of the St. Jude Medical (SJM) valve, representing bilcaflet valve design, and the Meditronic-Hall (MH) valve, representing mono-leaflet valve design. The test program utilized a flow visualization technique to map the velocity field inside the simulated ventricle. The study was carried out using a sophisticated cardiac simulator in conjunction with a high-speed video system (200 frames·s−1). The continuous monitoring of velocity-vector time histories revealed useful details about the complex flow and helped establish the locations and times of the peak parameter values. Comparison of the velocity profiles at corresponding flow phases reveals the effects of the differences in valve design and orientation. Based on precise examination of the data, the following general conclusions can be made: pulsatile flow creates three distinct flow phases consisting of accelerating, peak, and decelerating flow; the bileaflet CM and ATS valves in the antianatomical orientation generally create a single, large circulatory flow; the ATS valve scems to offer smoother flow patterns, similar to the SJM valve; and the monoleaflet BV valve and the BS monostrut valve seem to affect the flow characteristics more dramatically, with the posterior orientation exhibiting simple and stable circulatory flow.

Effect of the Sinus of Valsalva on the Closing Motion of Bileaflet Prosthetic Heart Valves

Conventional bileaflet prosthetic mechanical heart valves close passively with backflow. Naturally, the valve has problems associated with closure, such as backflow, water hammer effect, and fracture of the leaflet. On the other hand, in the case of the natural aortic valve, the vortex flow in the sinus of Valsalva pushes the leaflet to close, and the valve starts the closing motion earlier than the prosthetic valve as the forward flow decelerates. This closing mechanism is thought to decrease backflow at valve closure. In this study, we propose a new bileaflet mechanical valve resembling a drawbridge in shape, and the prototype valve was designed so that the leaflet closes with the help of the vortex flow in the sinus. The test valve was made of aluminum alloy, and its closing motion was compared to that of the CarboMedics (CM) valve. Both valves were driven by a computer controlled hydraulic mock circulator and were photographed at 648 frames/s by a high speed charge-coupled device (CCD) camera. Each frame of the valve motion image was analyzed with a personal computer, and the opening angles were measured. The flow rate was set as 5.0 L/min. The system was pulsed with 70 bpm, and the systolic/diastolic ratio was 0.3. Glycerin water was used as the circulation fluid at room temperature, and polystyrene particles were used to visualize the streamline. The model of the sinus of Valsalva was made of transparent silicone rubber. As a result, high speed video analysis showed that the test valve started the closing motion 41 ms earlier than the CM valve, and streamline analysis showed that the test valve had a closing mechanism similar to the natural one with the effect of vortex flow. The structure of the test valve was thought to be effective for soft closure and could solve problems associated with closure.

Bileaflet mechanical prostheses performance in mitral position.

The experience with the Carbomedics (CM) and the St. Jude Medical (SJM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. From 1989 to 1994, a total of 625 patients had mitral valve replacement (CM, 240; SJM, 385); 32.5% (203), concomitant procedures and 32.8% (205), previous cardiac surgery, primarily valve replacement procedures. The pre-operative variables did not distinguish the populations, except for previous surgery CM 37.9% and SJM 29.6% (P < 0.05). The pre-operative variables (type of prostheses, cardiac rhythm, coronary artery bypass, NYHA III/IV, advancing age, gender, urgency status and previous surgery) were not predictive of overall thromboembolism (TE), major TE, minor TE, prosthesis thrombosis and hemorrhage (P not significant; P = NS). The linearized rate of total TE events for overall MVR was 5.0%/patient-year (CM 4.4; SJM 5.4). The < or = 30 day major crude rate was 0.44%, while the > 30 day late major event rate was 2.0%/patient-year. Of the total TE events 91% of < or = 30 days and 75%, > 30 days had an INR < 2.5 at or immediately prior to the event. The thrombosis rate (included in TE events) was 0.63%/patient-year (ten events, four managed successfully with thrombolysis, five successfully with reoperation, and one fatality identified at autopsy). The freedom, at 5 years, from major/fatal TE, thrombosis and hemorrhage from anticoagulation was 88.2%, and 89.5% exclusive of early events. This non-randomized prospective observational evaluation of the CarboMedics and St. Jude Medical prostheses has not revealed any differentiation in performance of the prostheses. The study serves as a single institution experience with the potential for future comparative evaluation.

Outcome analysis of 245 CarboMedics and St. Jude valves implanted at the same institution

Background. Thromboembolism and valve-related death are major complications associated with prosthetic valve implants, but it is difficult to evaluate the relative incidence of these complications based on studies in which the implantation of only one valve is reported from any given institution. We therefore report the outcome of patients implanted at our institution during the same time period with either the recently released CarboMedics (CM) or the St. Jude Medical (SJ) valve prostheses. Methods. Between October 1994 and January 1996, 245 consecutive patients received either SJ (116 patients) or CM (129 patients) valves at our institution. Follow up of these patients was 99.6% complete, for a total of 318.5 cumulative patient-years (median follow-up, 1.4 years). Results. The 30-day mortality rates for SJ and CM implants were 3.4% and 3.1%, respectively. Actuarial survival and freedom from valve related mortality rates at 1.5 years for SJ and CM valves were 94% ± 2% versus 86% ± 3% ( p = 0.03) and 100% versus 94% ± 2% ( p = 0.005), respectively. There was no structural valve failure for either implant, but there were five thrombosed valves in the CM group and none in the SJ group ( p = 0.04). All thrombosed valves were mitral (four mitral valve replacement, one aortic and mitral valve replacement). Two of the thrombosed valves were successfully explanted, whereas the three remaining patients died. Freedom from a thromboembolic event in the mitral position at 1.5 years, including thrombosed valves was 97% ± 3% and 83% ± 5% for SJ and CM valves, respectively ( p = 0.04). Conclusions. The results of this study suggest that further evaluation of thromboembolic outcomes after CM compared with SJ valve implantation is warranted.

Multiple mechanical valve replacement surgery comparison of St. Jude Medical and CarboMedics prostheses.

The experience with the St. Jude Medical (SJM) and CarboMedics (CM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. From 1989 to 1994, a total of 246 patients had multiple valve replacement (SJM, 140; CM, 106); concomitant procedures 20.3% (50) [coronary artery bypass 10.6% (26)] and 53.7% (132) previous cardiac surgery, primarily valve replacement procedures. The pre-operative variables [coronary artery disease, previous cardiovascular surgery, concomitant procedures, valve lesion (except mitral stenosis), status, atrial fibrillation, and NYHA III/IV] did not distinguish the prosthesis-type (pNS). The prosthesis-type and the pre-operative variables, including atrial fibrillation, were not predictive of overall thromboembolism (TE). The linearized rate of total TE events for overall multiple replacements (MR) was 5.4%/patient-year (minor, 2.52; major 2.85); the total TE for CM and SJM was 5.4%/patient-year, respectively. The < or = 30 day major TE crude rate was 0.82%, while the > 30 day major event rate was 2.7%/patient-year. Of the total (major and minor) TE events 100% (3) of < or = 30 days and 72% (29), > 30 days had an INR < 2.5 at or immediately prior to the event. The thrombosis rate (included in total TE events) was 0.67%/patient-year (4 events, 100% INR < 2.5). Of the various TE event categories the prosthesis-types (CM and SJM) were not differentiated (pNS). The freedom, at 5 years, from major/fatal TE, thrombosis and hemorrhage from anticoagulation was 89.3 +/- 3.8% for CM and 87.9 +/- 3.7% for SJM and, 91.3 +/- 3.5% and 89.3 +/- 3.7%, respectively, (pNS) exclusive of early events. The performance of the CarboMedics and St. Jude Medical prostheses in multiple valve replacement surgery in this non-randomized prospective study revealed no significant differences in performance with regard to thromboembolic and hemorrhagic complications.

Pulse duplicator hydrodynamics of four different bileaflet valves in the mitral position

The hydrodynamic performance of four different types of bileaflet heart valve was tested both in steady flow conditions and in a newly designed computerized artificial left heart system. Four 29-mm valves, manufactured by either St. Jude Medical, CarboMedics, ATS Medical or Medtronic Parallel were studied under a steady state and in pulsatile conditions by pressure and flow recording and colour Doppler echocardiography in the `mitral position' at rest and at exercise (cardiac output range 4–30 l/Min). In the steady state, significant differences were measured at peak flows of 30 l/min, with mean (s.d.) increasing pressure drops (mmHg) recorded at 3.48(0.13) (St. Jude Medical), 3.80(0.11) (Medtronic Parallel), 4.31(0.06) (ATS Medical) (P<0.005), and 4.78(0.06) (Carbo Medics), (P<0.005). The mean ratio of the closing volume to the stroke volume was comparable for all valves despite one faulty sample. In the pulsatile state the effective orifice area calculated by the Continuity and Gorlin equations decreased from 2.10(0.04) (ATS Medical), 1.95(0.05) (St. Jude Medical), 1.87(0.03) (Carbo Medics) to 1.67(0.02) (Medtronic Parallel) independently of method used. No significant difference was found in the mean ratio of the regurgitant volume to the stroke volume. The performance index, defined as the ratio of effective orifice area to geometric orifice area ranks the valves in the order ATS Medical (0.44), St. Jude Medical (0.43), Carbo Medics (0.41) and Medtronic Parallel (0.38). Regurgitation visible on colour Doppler echo was a mere consequence of the working principle of the bileaflet valves in the mitral position and was by no means hydrodynamically important nor representatire of severe insufficiencies. Differences between the valve types were notable under severe conditions, such as high peak flow.

Pulse Duplicator Hydrodynamics of Four Different Bileaflet Valves in the Mitral Position

The hydrodynamic performance of four different types of bileaflet heart valve was tested both in steady flow conditions and in a newly designed computerized artificial left heart system. Four 29-mm valves, manufactured by either St. Jude Medical, CarboMedics, ATS Medical or Medtronic Parallel were studied under a steady state and in pulsatile conditions by pressure and flow recording and colour Doppler echocardiography in the ‘mitral position’ at rest and at exercise (cardiac output range 4–30 l/Min). In the steady state, significant differences were measured at peak flows of 30 l/min, with mean (s.d.) increasing pressure drops (mmHg) recorded at 3.48(0.13) (St. Jude Medical), 3.80(0.11) (Medtronic Parallel), 4.31(0.06) (ATS Medical) ( P &lt; 0.005), and 4.78(0.06) (Carbo Medics), ( P &lt; 0.005). The mean ratio of the closing volume to the stroke volume was comparable for all valves despite one faulty sample. In the pulsatile state the effective orifice area calculated by the Continuity and Gorlin equations decreased from 2.10(0.04) (ATS Medical), 1.95(0.05) (St. Jude Medical), 1.87(0.03) (Carbo Medics) to 1.67(0.02) (Medtronic Parallel) independently of method used. No significant difference was found in the mean ratio of the regurgitant volume to the stroke volume. The performance index, defined as the ratio of effective orifice area to geometric orifice area ranks the valves in the order ATS Medical (0.44), St. Jude Medical (0.43), Carbo Medics (0.41) and Medtronic Parallel (0.38). Regurgitation visible on colour Doppler echo was a mere consequence of the working principle of the bileaflet valves in the mitral position and was by no means hydrodynamically important nor representatire of severe insufficiencies. Differences between the valve types were notable under severe conditions, such as high peak flow.

Platelet interaction with pyrolytic carbon heart-valve leaflets.

Although the newest generation of mechanical heart-valve prosthetics constructed either partially or wholly of lowtemperature isotropic pyrolytic carbon (LTIC) have significantly reduced thromboembolic complications compared with early-generation mechanical valves (e.g., Starr-Edwards), thromboembolism remains an important clinical complication. In the present study, high-resolution, lowvoltage scanning electron microscopy (HR-LV-SEM) was used to examine the structure and platelet interaction properties of LTIC valve leaflets manufactured by both Carbo Medics, Inc. and by St. Jude Medical, Inc. Valve leaflets from both manufacturers, prepared and polished exactly as used in clinical heart valves, had similar surface energetics and elemental composition. Examination with LV-SEM revealed a rough and complex three-dimensional surface structure with nanometer- to micron-size features. In vitro adhesion of human platelets on the LTIC materials and Formvar were evaluated in the presence of 1 mg/mL albumin. Platelet-surface activation, as evaluated by shape change, spread area, and deposition, was extremely extensive on the LTIC materials compared with the Formvar positive control material. LTIC-adherent platelets were extremely thin, and closely followed the rough LTIC contours, greatly limiting their visibility with conventional SEM. These observations demonstrate that LTIC surfaces can extensively activate platelets even in the presence of albumin, thereby suggesting that platelet interactions with pyrolytic carbon may have a significant role in mechanical-valve thromboembolism.

Pulsatile flow past bileaflet aortic valve prostheses

Abstract The pulsatile flow fields downstream of the three aortic bileaflet mechanical valves: St. Jude Medical (SJM), CarboMedics (CM), Edwards Tekna (modified Duromedics, DM) have been investigated in vitro. An experimental circulatory mock loop has been used to simulate the left heart under the conditions of geometric and dynamic similarities. These tested valves have been mounted on the base of a glass‐made model aorta with symmetrical sinus. The blood analog fluid has a viscosity of 3.9 cP and has matching refractive index with the model aorta. Experimental parameters have been set at the rate of 70 heartbeats and 5 liters of flow per minute. A two‐component laser Doppler anemometer has been used to measure the distributions of pulsatile velocities at five different axial locations inside the sinus of the aorta. Results show that although all the three valves are aortic bileaflet valves, they have different flow patterns, due to their different opening angles, shapes of leaflets and movements of hing...