Left ventricular mass regression after aortic valve replacement with 17-mm St Jude Medical mechanical prostheses in isolated aortic stenosis

OBJECTIVE: The present study investigated the outcomes of aortic valve replacement with 17-mm mechanical prostheses in patients with isolated aortic stenosis. METHODS: Between January 1997 and January 2003, 35 patients (mean age, 63.4 +/- 17 years; median age, 70 years; age range, 16-84 years) underwent isolated aortic valve replacement with a 17-mm St Jude Medical Hemodynamic Plus (16 [45.7%] patients) or a St Jude Medical Regent prosthesis (19 [54.3%] patients). The paired Student t test or the paired Wilcoxon rank sum test were used to compare preoperative with follow-up echocardiographic measurements. RESULTS: Thirty-two (91.4%) patients were female, mean height was 154.4 +/- 8.3 cm, mean weight was 62.2 +/- 9.2 kg, and mean body surface area was 1.59 +/- 0.13 m 2 . The preoperative average New York Heart Association class was 2.8 +/- 0.8. The mean preoperative left ventricular mass index was 135.2 +/- 31 g/m 2 . Preoperative echocardiography showed an average gradient of 65.7 +/- 19.2 mm Hg (mean) and 103.6 +/- 30.7 mm Hg (peak) and a mean indexed effective orifice area of 0.40 +/- 0.1 cm 2 /m 2 . Echocardiographic follow-up time averaged 28.2 +/- 22.7 months (range, 13-72 months). Follow-up was 100% complete (1131.7 patient-months). Hospital mortality was 8.6% (3 patients). Actuarial 5-year survival was 94.7%. The mean postoperative New York Heart Association class was 1.13 +/- 0.34 ( P < .001), with 27 (87.1%) patients in class I and 4 patients in class II. A significant regression of the indexed left ventricular mass was found (postoperative mean value, 107.8 +/- 22.8 g/m 2 ; P < .0001), despite a mean indexed effective orifice area of 0.67 +/- 0.14 cm 2 /m 2 (median, 0.66 cm 2 /m 2 ). CONCLUSIONS: Selected patients with aortic stenosis can experience satisfactory clinical improvement and significant indexed left ventricular mass regression after aortic valve replacement with modern small-diameter bileaflet prostheses.     

Experimental evaluation and early clinical results of a new low-profile bileaflet aortic valve

We performed an experimental and clinical evaluation of a new low-profile bileaflet aortic valve (Regent, St. Jude Medical Inc., St. Paul, MN, U.S.A.). Common valve sizes were experimentally tested for leakage volume, pressure drop, and transvalvular hemodynamics using a pulse duplicator. Thirty patients (mean age 60 +/- 7 years, predominant valve stenosis n = 25) received the Regent prosthesis for initial clinical evaluation. In vitro evaluation revealed equivalent leakage volumes, larger performance indices (0.552 versus 0.513), and lower pressure drops in comparison to SJM hemodynamic plus valve controls. Clinically, 21 mm (n = 9), 23 mm (n = 12), and 25 mm (n = 9) valves were implanted with no significant perioperative complications. Echocardiography revealed low transvalvular flow velocities (2.2 +/- 0.4 m/s) and low pressure gradients (20 +/- 6 mm Hg) postoperatively and at 6 months follow-up. In vitro testing and early clinical results are promising; however, long-term performance has to be proven.     

Early in vivo hemodynamic results after aortic valve replacement with the St Jude Medical Regent mechanical heart valve in patients with pure aortic stenosis

BACKGROUND: The St Jude Medical Regent is a new-generation mechanical heart valve that represents a design evolution of the St Jude Hemodynamic Plus Series (HP). The purpose of this study was to evaluate early "in vivo" hemodynamic performance of the Regent valve in patients with aortic stenosis. METHODS: Between March 2000 and December 2001, 32 patients (mean age 59.9 +/- 5.9,56.3% male) with pure aortic stenosis received a Regent mechanical prosthesis in the aortic position. Hemodynamic performance was assessed by Doppler echocardiography at discharge, two months, six months, and one year by calculating peak transprosthetic velocity (Vmax), mean (MG) and peak (PG) transprosthetic gradients, effective orifice area index (EOAI), left ventricular mass index (LVMI), and degree of aortic regurgitation. RESULTS: A significant reduction in mean and peak transaortic gradients (p < 0.001) and a significant increase in EOAI (p < 0.001) over time followed valve replacement, and a bivariate analysis of variance (ANOVA) failed to demonstrate statistical differences by valve size over time (p = ns). A significant reduction in left ventricular hypertrophy occurred over time (p < 0.001) in all valve sizes (p = ns between groups): baseline LVMI was 221 +/- 57 g/cm2; it decreased by 30 g/cm2 (p < 0.001) at discharge. LVMI decreased from 191 +/- 54 g/cm2 to 161 +/- 41 g/cm2 (p < 0.001) from discharge to two months. Further reductions were not significant. At the six-month follow-up no patient in our cohort exhibited moderate or severe aortic regurgitation at Doppler echocardiography. CONCLUSIONS: Early results with the St Jude Medical Regent valve have been satisfactory. Further assessments are necessary to confirm these results.     

Clinical outcome in patients with 19-mm and 21-mm St. Jude aortic prostheses: comparison at long-term follow-up

BACKGROUND: Small-sized prostheses for aortic valve replacement may result in residual left ventricular outflow tract obstruction. Aim of the study was to verify whether implantation of 19-mm versus 21-mm St. Jude Medical standard prostheses (St. Jude Medical, Inc, St. Paul, MN) influences long-term clinical outcome. METHODS: Two hundred twenty-nine patients who underwent aortic valve replacement with 19 mm (group 1, 53 patients) or 21-mm St. Jude Medical standard prostheses (group 2, 176 patients) were included in the study. Mean follow-up of current survivors was 10+/-4 years. RESULTS: Operative mortality was 7.5% in group 1 and 8.5% in group 2. At discharge, an important patient-prosthesis mismatch (effective orifice area index < or = 0.60 cm2/m2) was present in 18% of group 1 versus 5% in group 2 (p = 0.004). Among patients with body surface area less than 1.70 m2, such mismatch was present in 15% of group 1 versus 2% of group 2 (p = 0.008). At last follow-up New York Heart Association (NYHA) functional class (p < 0.001), left ventricular mass reduction (p = 0.02), mean (p = 0.002) and peak transprosthetic gradients (p < 0.001), and effective orifice area index (p = 0.005) were significantly better in group 2. Freedom from sudden death (92%+/-5% vs 99%+/-1%, p = 0.01), valve-related death (84%+/-6% vs 90%+/-5%, p = 0.02), and cardiac events (56%+/-13% vs 86%+/-4%, p = 0.008), were significantly lower in group 1. Effective orifice area index was an independent predictor of late cardiac events. CONCLUSIONS: Although long-term results after aortic valve replacement with small-sized St. Jude Medical standard prostheses are satisfactory, 19-mm valve recipients show a high prevalence of important patient-prosthesis mismatch with less evident functional improvement and higher rate of cardiac events, suggesting a very cautious use of this prosthesis.     

Assessment of effective orifice area of prosthetic aortic valves with Doppler echocardiography: an in vivo and in vitro study

OBJECTIVES: We sought to evaluate the Doppler assessment of effective orifice area in aortic prosthetic valves. The effective orifice area is a less flow-dependent parameter than Doppler gradients that is used to assess prosthetic valve function. However, in vivo reference values show a pronounced spread of effective orifice area and smaller orifices than expected compared with the geometric area. METHODS: Using Doppler echocardiography, we studied patients who received a bileaflet St Jude Medical valve (n = 75; St Jude Medical, Inc, St Paul, Minn) or a tilting disc Omnicarbon valve (n = 46; MedicalCV, Incorporated, Inver Grove Heights, Minn). The prosthetic valves were also investigated in vitro in a steady-flow model with Doppler and catheter measurements in the different orifices. The effective orifice area was calculated according to the continuity equation. RESULTS: In vivo, there was a wide distribution with the coefficient of variation (SD/mean x 100%) for different valve sizes ranging from 21% to 39% in the St Jude Medical valve and from 25% to 33% in the Omnicarbon valve. The differences between geometric orifice area and effective orifice area in vitro were 1.26 +/- 0.41 cm(2) for St Jude Medical and 1.17 +/- 0.38 cm(2) for Omnicarbon valves. The overall effective orifice areas and peak catheter gradients were similar: 1.35 +/- 0.37 cm(2) and 25.9 +/- 16.1 mm Hg for St Jude Medical and 1.46 +/- 0.49 cm(2) and 24.6 +/- 17.7 mm Hg for Omnicarbon. However, in St Jude Medical valves, more pressure was recovered downstream, 11.6 +/- 6.3 mm Hg versus 3.4 +/- 1.6 mm Hg in Omnicarbon valves (P =.0001). CONCLUSIONS: In the patients, we found a pronounced spread of effective orifice areas, which can be explained by measurement errors or true biologic variations. The in vitro effective orifice area was small compared with the geometric orifice area, and we suspect that nonuniformity in the spatial velocity profile causes underestimation. The St Jude Medical and Omnicarbon valves showed similar peak catheter gradients and effective orifice areas in vitro, but more pressure was recovered in the St Jude Medical valve. The effective orifice area can therefore be misleading in the assessment of prosthetic valve performance when bileaflet and tilting disc valves are compared.     

Valve replacement in narrow aortic roots: serial hemodynamics and long-term clinical outcome

No long-term data are available that correlate clinical outcome with serial hemodynamic studies for small-diameter (17-mm or 19-mm) aortic prostheses implanted without enlargement of the annulus. After insertion of these valves without annuloplasty, 52 patients underwent resting catheterization and were followed up at the Surgery Clinic of the National Heart, Lung, and Blood Institute for 295 patient-years (mean, 5.7 years per patient). At similar flow rates, peak systolic gradients across 17-mm Bj?rk-Shiley aortic prostheses (N = 6) tended to exceed those of the 19-mm Bj?rk-Shiley model (N = 38); these gradients averaged 30 +/- 6 mm Hg (mean +/- standard error of the mean) and 20 +/- 2 mm Hg, respectively (p = .053). Those patients with 19-mm Hancock (N = 4) and St. Jude Medical valves (N = 4) were studied, and the lowest prosthetic gradients were found with the St. Jude Medical prosthesis (mean, 3 +/- 2 mm Hg). Aortic gradient was independent of flow for 17-mm but not for 19-mm Bj?rk-Shiley valves. There was no difference in calculated effective orifice area with respect to valve size. Effective orifice area and prosthetic gradients were stable during intervals of 2 to 12 years in 10 patients who underwent additional catheterizations. No association was found between prosthetic gradients, flows, or calculated orifice areas and early or late functional class. Actuarial survival was 86 +/- 5% at 5 years, 83 +/- 5% at 8 years, 71 +/- 9% at 10 years, and 60 +/- 12% at 12 years of complete follow-up. It is concluded that small aortic prostheses provide acceptable palliation for long periods and that resting hemodynamic studies have a limited predictive value for long-term prognosis.     

Left ventricular outflow tract obstruction with mitral valve replacement in small ventricular cavities

The inference that mitral valve replacement (MVR) may produce left ventricular outflow tract (LVOT) obstruction has been made, but no comparative hemodynamic studies with various types of prostheses have been done. The purpose of the present study was to compare the gradients created across the LVOT with MVR in young sheep with small left ventricular cavities. Mitral valve replacement was accomplished using cardiopulmonary bypass and hypothermic cardioplegic arrest. Five animals were used for each of the following valves studied: 25-mm Ionescu-Shiley bovine pericardial valve, 25-mm Hancock porcine aortic valve, 2M-6120 28-mm Starr-Edwards ball-valve prosthesis, 25-mm Bj?rk-Shiley 60-degree flat tilting-disc prosthesis, and 25-mm St. Jude Medical hemidisc valve. Gradients across the LVOT were measured after MVR and then during infusion of isoproterenol hydrochloride (0.05 micrograms/kg/min). Following MVR, only the Starr-Edwards valve produced an LVOT gradient (32 +/- 23 mm Hg). Substantial gradients after MVR were seen, however, with isoproterenol administration with the Ionescu-Shiley (47 +/- 4 mm Hg), Hancock (13 +/- 8 mm Hg), and Starr-Edwards (65 +/- 30 mm Hg) valves but not with the low-profile valves (Bj?rk-Shiley and St. Jude Medical). The results of the present study demonstrate that MVR can produce LVOT obstruction. The greatest degree of obstruction was with the high-profile mechanical and bioprosthetic valves.     

Rest and exercise hemodynamics of 20 to 23 mm allograft, Medtronic Intact (porcine), and St. Jude Medical valves in the aortic position

Doppler echocardiography was used to measure gradients and valve areas at rest and after supine bicycle exercise in 35 patients with valve replacements 20 to 23 mm in size. Thirteen patients with a St. Jude Medical valve (St. Jude Medical, Inc., St. Paul, Minn.) were matched to 13 patients with an allograft valve, and seven patients with a Medtronic Intact (porcine) valve (Medtronic, Inc., Minneapolis, Minn.) to seven patients with an allograft valve. Patients were matched for age, sex, valve size, body surface area, and left ventricular systolic function. There was no statistically significant difference between the matched groups for body surface areas, resting cardiac output, exercise heart rate, or workload achieved. Mean pressure gradient was higher for St. Jude Medical than for allograft groups, both at rest (11.8 +/- 6.67 mm Hg for St. Jude Medical versus 6.67 +/- 2.98 mm Hg for allografts) and after exercise (16.4 +/- 8.47 mm Hg versus 9.7 +/- 3.94 mm Hg), but the differences were of borderline significance (p = 0.016 and 0.027, respectively). Valve area at rest was similar for both devices (1.4 +/- 0.45 cm2 for St. Jude Medical versus 1.8 +/- 0.56 cm2 for allograft; p greater than 0.1). There were highly significant differences between patients with Intact and those with allograft valves for resting mean pressure gradient (19.3 +/- 4.23 mm Hg for Intact versus 5.9 +/- 3.68 mm Hg for allograft; p less than 0.001) and for exercise mean pressure gradient (27.8 +/- 8.63 mm Hg versus 8.1 +/- 8.43 mm Hg; p less than 0.001). The differences between the valve areas at rest also were significant (1.1 +/- 0.12 cm2 versus 2.2 +/- 0.62 cm2; p less than 0.01). It is concluded that when a tissue valve is indicated in patients with a small aortic root, the freehand allograft aortic valve is an ideal device from the hemodynamic perspective and is superior to the Intact valve. It is also probably superior in this respect to the St. Jude Medical valve, although the analysis may be biased slightly in favor of the allograft valve.     

Flow Characteristics of the St. Jude Prosthetic Valve: An In Vitro and In Vivo Study

The St. Jude cardiac prosthetic aortic valve was evaluated in vitro and in vivo in an attempt to establish flow characteristics and to correlate them with clinical findings. In vitro, a fluid vehicle (6% Polyol V-10, 32°C) with viscosity similar to blood (0.035 dyne-sec/cm²) was used under conditions of steady flow through a flow chamber simulating the aortic root. Gradient, velocity, and shear stress were measured 5.79 mm, 26.79 mm, 44.79 mm, and 77.79 mm downstream from 25-mm and 27-mm valves using a laser-Doppler anemometer. At 417 ml/sec, the valve gradient was 6.2 mmHg with the 25-mm valve, and 5.2 mmHg with the 27-mm prosthesis. Velocity was maximum at the orifice center, and wall shear stress was low (maximum 600 dyne/cm²). In vivo, six patients with 25-mm St. Jude aortic valves were studied within 48 hours after surgery to determine cardiac output, valve flow, and gradient. The gradient was 3.3 ± 1.9 mmHg (M ± SD) at 249 ± 96 ml/sec and the effective valve area was as large as the geometric area (2.58 vs. 3.09 cm²). Thus, flow through the St. Jude valve is unobstructed and central, has low turbulence, and achieves optimal effective valve area for a given available orifice area.     

Serial Doppler echocardiographic evaluation of small-sized sorin bicarbon prostheses

OBJECTIVE: The Sorin Bicarbon prosthesis (Sorin Biomedica, Saluggia, Italy) is a bileaflet valve with curved-profile leaflets, a rolling hinge mechanism, and a pyrolytic carbon-coated titanium alloy housing and sewing ring. Although the Sorin Bicarbon prosthesis has been implanted in greater than 80,000 patients, and reference values on the hemodynamic performance of valve prostheses are needed to avoid patient-prosthesis mismatch, few Doppler echocardiographic data are available on the prosthesis in the aortic position. The aim of this study is to provide a detailed echocardiographic evaluation of the hemodynamic performance and regression of left ventricular hypertrophy after aortic valve replacement with the Sorin Bicarbon prosthesis. METHODS: The study included 182 patients who received a 21-mm (n = 61) or 23-mm (n = 121) Sorin Bicarbon prosthesis for pure or prevalent aortic stenosis who underwent serial echocardiograms at 3, 6, and 12 months after aortic valve replacement. RESULTS: Mean and peak gradients significantly decreased (P <.001) during follow-up to values of 12 +/- 3 and 22 +/- 6 mm Hg for the 21-mm prosthesis and values of 11 +/- 4 and 19 +/- 6 mm Hg for the 23-mm prosthesis at 1 year. Left ventricular mass index showed a 17% decrease to 120 +/- 27 g/m(2) in recipients of the 21-mm prosthesis (P <.001) and a 21% decrease to 123 +/- 29 g/m(2) in recipients of the 23-mm prosthesis (P <.001). A larger prosthesis size was the only predictor of a higher left ventricular mass index regression. Among recipients of the 21-mm prosthesis, body surface area of greater than 1.85 m(2) was associated with a lower regression of left ventricular mass index. The effective orifice area index was 1.00 +/- 0.11 and 1.08 +/- 0.14 cm(2)/m(2) in recipients of the 21-mm and 23-mm prostheses, respectively. CONCLUSIONS: Size 21 mm and 23 mm Sorin Bicarbon prostheses show low transprosthetic gradients, with significant reduction of left ventricular mass index during the first postoperative year. The reported effective orifice areas might be useful for aortic valve replacement in patients with a small aortic annulus to avoid patient-prosthesis mismatch.     

A case of aortic valve replacement with St. Jude Medical Regent valve (first implant in Japan).

The St. Jude Medical (SJM) Regent valve was developed as a new mechanical valve by improving the conventional SJM valve. The effective orifice area is wider than that of Hemodynamic Plus (HP) series. The efficacy of the new valve has been reported in Europe and the United States. On October 26, 2004, we first performed aortic valve replacement (AVR) with the SJM Regent valve for aortic valve stenosis in Japan. A 64-year-old female was admitted to our hospital with dyspnea on exertion. She was diagnosed with aortic valve stenosis. She underwent AVR with a 17 mm SJM Regent valve. According to the results of echocardiography conducted two months postoperatively, the peak pressure gradient of the prosthetic valve was 32.0 mmHg, the mean pressure gradient was 13.2 mmHg, and the effective orifice area index (EOAI) was 0.92 cm2/m2. Cinefluoroscopy showed the valve opening angle of 85 degrees indicating full opening. She was discharged 15 days after surgery without complications. As demonstrated by the present case, implantation of a 17 mm SJM Regent valve produced a satisfactory result reflected by lower pressure gradient and absence of patient-prosthetic mismatch. In the future, the new valve is expected to be the optimum mechanical valve for a narrow annulus.     

Evaluation of 17-mm St. Jude Medical Regent prosthetic aortic heart valves by rest and dobutamine stress echocardiography

Background  

The prosthesis used for aortic valve replacement in patients with small aortic root can be too small in relation to body size, thus showing high transvalvular gradients at rest and/or under stress conditions. This study was carried out to evaluate rest and Dobutamine stress echocardiography (DSE) hemodynamic response of 17-mm St. Jude Medical Regent (SJMR-17 mm) in relatively aged patients at mean 24 months follow-up.     

Performance of 21-mm size perimount aortic bioprosthesis in the elderly

BACKGROUND: Aortic valve replacement in elderly patients with a small aortic annulus may pose difficult problems in terms of prosthesis selection. We have evaluated the hemodynamic performance of the 21-mm Carpentier-Edwards Perimount bioprosthesis implanted in elderly patients. METHODS: From July 1996 to June 1998, 19 patients (17 women and 2 men, mean age 76+/-4 years and mean body surface area 1.73+/-0.13 m2), had aortic valve replacement with a 21-mm Carpentier-Edwards Perimount bioprosthesis. The hemodynamic performance of the valve was evaluated in 16 patients, who completed at least a 6-month follow-up interval, with transthoracic color-Doppler echocardiography with particular reference to peak and mean transprosthetic gradients, effective orifice area index, and regression of left ventricular mass index. RESULTS: There were no late deaths and no major postoperative complications. At a mean follow-up of 12+/-7 months, compared to discharge, all patients showed clinical improvement with a significant reduction of peak gradient (from 23+/-4 to 21+/-6 mm Hg, p = 0.04) and left ventricular mass index (from 181+/-23 to 153+/-20 g/m2; p<0.001), whereas mean gradient (from 13+/-3 to 13+/-4 mm Hg, p = not significant) and effective orifice area index (from 1.12+/-0.34 to 1.13+/-0.28 cm2/m2, p = not significant) remained substantially unchanged. CONCLUSIONS: The use of a 21-mm Carpentier-Edwards Perimount bioprosthesis is associated with low transprosthetic gradients and significant reduction in left ventricular hypertrophy after aortic valve replacement. The results of our study suggest that a 21-m Carpentier-Edwards Perimount bioprosthesis should be considered a valid option in elderly patients with aortic valve disease and a small aortic annulus.     

Microflow fields in the hinge region of the CarboMedics bileaflet mechanical heart valve design

OBJECTIVE: The design of bileaflet mechanical heart valves includes some degree of leakage flow on valve closure for the reverse flow to wash the hinge and pivot region of the valve. It is believed that this reverse flow helps to prevent areas of stasis and inhibit microthrombus formation. However, the magnitude of this retrograde flow may also give rise to unacceptable levels of blood element damage and lead to platelet activation or hemolysis as a result of the increased flow velocities through the hinge region. The purpose of this study was to evaluate the hinge flow dynamics of a 23-mm CarboMedics bileaflet mechanical valve (Sulzer CarboMedics Inc, Austin, Tex) and then to compare the results with those of the St Jude Medical 23-mm Regent (St Jude Medical Inc, Minneapolis, Minn) and Medtronic Parallel (Medtronic, Inc, Minneapolis, Minn) valves studied earlier. This comparison allows new insight into the microflow fields within the hinge region of the CarboMedics bileaflet mechanical valve, which have not been previously assessed during its clinical history. METHODS: Two-dimensional laser Doppler velocimetry was used to measure the velocity and turbulent shear stress fields in the hinge regions. To conduct these measurements, exact dimensional models of the bileaflet hinge regions were cast or machined from transparent plastic materials. The experiment was conducted in a pulsatile flow loop with measurements taken at different levels within the pivot and hinge regions. RESULTS: In the 23-mm CarboMedics valve hinge, the phase-averaged forward velocity obtained at the flat level and levels of 190 microm and 390 microm above flat and 1 mm below flat were 0.54 m/s, 0.77 m/s, 0.3 m/s, and 1.0 m/s, respectively. Corresponding values of the peak phase-averaged leakage velocities were 3.17 m/s, 2.91 m/s, 2.52 m/s, and 0.5 m/s, respectively. Corresponding turbulent shear stresses were 5510 dyne/cm(2), 5640 dyne/cm(2), 4380 dyne/cm(2), and 4810 dyne/cm(2), respectively. CONCLUSIONS: The hinge flow dynamics of the CarboMedics bileaflet design lie somewhere in between those of the St Jude Medical and the Medtronic Parallel valve designs. The fluid dynamics of the investigated valve were found to be similar to those of the St Jude Medical valves, although with slightly higher leakage velocities and turbulent shear stresses. This discrepancy may be a result of the sharper corners associated with the hinge design of the CarboMedics valve. It could also be due to the incremental enlargement of the internal orifice area of the St Jude Medical Regent design.     

A comparison of the hinge and near-hinge flow fields of the St Jude medical hemodynamic plus and regent bileaflet mechanical heart valves

OBJECTIVE: The most widely implanted prosthetic valves are the mechanical bileaflets, most of which have good forward flow hemodynamics. However, recent clinical experiences illustrate the importance of understanding the flow structures generated within the hinge. The purpose of this study was to evaluate the hinge-flow dynamics of two new variations of a 17-mm St Jude Medical bileaflet valve: the Hemodynamic Plus and the Regent (St Jude Medical, Inc, St Paul, Minn). METHODS: Clinical quality reproductions of the valves were manufactured with clear housings. Laser Doppler velocimetry velocity and turbulent shear stress measurements were conducted within the hinge and thumbnail regions of the valves. RESULTS: In the 17-mm Hemodynamic Plus hinge, a rotating flow structure developed in the inflow pocket during forward flow. During systole, velocities through the hinge pocket reached 0.70 m/s, and the turbulent shear stress reached 1000 dynes/cm(2). In the thumbnail, forward flow velocities ranged from 1.4 m/s to 1.7 m/s. In the 17-mm Regent hinge, a rotating flow structure partially developed in the inflow pocket during forward flow. During systole, velocities through the hinge pocket reached 0.75 m/s, and the turbulent shear stress reached 1300 dynes/cm(2). In the thumbnail, forward flow velocities ranged from 1.0 m/s to 1.3 m/s. CONCLUSIONS: The active leaflet motion through the St Jude Medical hinge creates a washout pattern that restricts the persistence of stagnation zones and thus may be a contributing factor to its successful clinical performance. The hinge and thumbnail flow dynamics of the 17-mm Regent valve are at least equivalent to, and possibly superior to, those of the 17-mm Hemodynamic Plus valve.     

应用不同品牌机械瓣行主动脉瓣置换术患者的血流动力学变化

目的 探讨应用不同品牌19 mm机械瓣行单纯主动脉瓣置换术后早期血流动力学变化情况。 方法回顾性分析2007年1月至2012年1月北京安贞医院116例单纯主动脉瓣狭窄患者行主动脉瓣置换术后血流动力学变化,其中男61例、女55例,年龄（52±13） 岁。根据使用的瓣膜品牌将患者分为3组： SJ.Regent瓣膜组,38例（33%）,男20例、女18例,平均年龄（52±15） 岁; Carbomedics瓣膜组,40例（34%）,男21例、女19例,平均年龄（51±17） 岁。On-X瓣膜组,38例（33%）,男20例、女18例,平均年龄（55±16） 岁。比较患者术前和术后左心室收缩期末内径、左心室舒张期末内径、射血分数（EF）值、室间隔厚度、左心室壁厚度、主动脉瓣瓣上流速、跨瓣压差以及术后有效瓣口面积指数（EOAI）。 结果 三组患者术前及术后的左心室收缩期末内径、左心室舒张期末内径、EF值、室间隔厚度、左心室壁厚度差异均无统计学意义 （P＞0.05）。主动脉瓣瓣上流速和跨瓣压差术前、术后有差异有统计学意义。SJ.Regent瓣膜组和Carbomedics瓣膜组患者较On-X瓣膜组患者的术后主动脉瓣瓣上流速 ［（244.30±33.67） cm/s vs. （249.69±79.13） cm/s vs. （294.83±52.05） cm/s］和跨瓣压差［（27.77±3.33） mm Hg vs. （33.58±18.90） mm Hg vs. （38.56±13.21） mm Hg］明显偏小,其差异有统计学意义。 结论 运用19 mm机械瓣进行主动脉瓣置换术,SJ.Regent和Carbomedics瓣膜较On-X瓣膜有更好的血流动力学效果。     

Small aortic annulus: the hydrodynamic performances of 5 commercially available bileaflet mechanical valves

OBJECTIVE: Hemodynamic performances of mechanical valve prostheses in patients with aortic valve stenosis and a small aortic annulus are crucial. We analyzed the in vitro hydrodynamics of 5 currently available bileaflet mechanical prostheses that fitted a 21-mm-diameter valve holder of a Sheffield pulse duplicator. METHODS: Three samples of 5 high-performance production-quality prostheses, including the sewing ring cuffs, were tested in the aortic chamber of a Sheffield pulse duplicator. Sizes of the prostheses fitting the 21-mm valve holder were as follows: 18-mm ATS, 19-mm SJM Regent, 19-mm Sorin Bicarbon Slimline, 19-mm On-X, and 21-mm Carbomedics Top Hat. The tests were carried out at a fixed pulse rate (70 beats/min) and at increasing cardiac outputs of 2, 4, 5, and 7 L/min. Each valve was tested 10 times for each different cardiac output. This resulted in a total of 40 tests for each valve and 120 tests for each valve model. The aortic pressure was set at 120/80 mm Hg (mean pressure, 100 mm Hg) throughout the experiment for all cardiac outputs. Forward flow pressure decrease, total regurgitant volume, closing and leakage volumes, effective orifice area, and stroke work loss were recorded while the valve operated under each cardiac output. RESULTS: The SJM Regent valve and the Sorin Bicarbon Slimline prosthesis showed the lowest mean and peak gradients at increasing cardiac outputs. The closure volume was higher for the SJM Regent and Sorin Bicarbon Slimline prostheses, unlike with the ATS prosthesis at 7 L/min of cardiac output. The ATS and SJM Regent prostheses showed the largest regurgitant volume, whereas the Sorin Bicarbon Slimline prosthesis showed the lowest regurgitant volume. The calculated effective orifice area and stroke work loss were significantly better with the SJM Regent and Sorin Bicarbon Slimline prostheses. CONCLUSION: Assuming that the 21-mm valve holder in which all the tested prostheses were accommodated is comparable with a defined aortic valve size, this hydrodynamic evaluation model allowed us to compare the efficiency of currently available valve prostheses, and among these, the SJM Regent and the Sorin Bicarbon Slimline exhibited the best performances.     

Aortic and mitral valve replacement with the St. Jude Medical prosthesis

From April 1, 1979 to August 31, 1983, 228 patients underwent isolated aortic (AVR) (118) or mitral (MVR) (90) valve replacements with a new tilting disc valve prosthesis, the St. Jude prosthesis, at the Medical University of South Carolina. Age ranged from 6 to 84 years (mean 49.1 +/- 19.2 AVR, 44.5 +/- 16.5 MVR). Male sex predominated in the AVR group (68%) and female sex in the MVR group (68%). Thirty-five patients (16.8%) had associated coronary bypass surgery (AVR 23.7%, MVR 7.8%). There were seven deaths (3.4%) occurring during the same hospitalization (AVR: 3/118, 2.5%; MVR: 4/90, 4.4%). Follow-up is 97.6% complete and ranges from 1 to 54 months (mean 19.6 +/- 12.4). In the AVR group, nine late deaths have occurred and actuarial survival at 42 months is 86.7 +/- 3.8%. Three patients have sustained thromboembolic episodes for a linearized rate of 1.6% patient-year, and the probability of remaining free of thromboembolism at 42 months is 96.9 +/- 1.8%. The mean improvement in functional class from preoperative to postoperative is 3.1 +/- 0.7 to 1.2 +/- 0.4 (p less than 0.001). In the MVR group, there have been four late deaths, and the actuarial survival at 42 months is 89.3 +/- 3.8%. Two patients have sustained thromboembolic complications for a linearized rate of 1.2%/patient-year, and the probability of remaining free of thromboembolism at 42 months is 97.2 +/- 2%. The mean improvement in functional class from before to after surgery is 3.2 +/- 0.7 to 1.3 +/- 0.5 (p less than 0.001). There have been no thromboses of the St. Jude valve in the mitral or aortic position, no mechanical failures, and no patient has had significant valve-related hemolysis. Because of this experience, the St. Jude Medical heart valve prosthesis is our prosthesis of choice for any patient undergoing valve replacement with a mechanical prosthesis.     

A comparison of the in vivo performance of the 19-mm St. Jude Medical Hemodynamic Plus and 21-mm standard valve

BACKGROUND: In the present study we analyzed the in vivo performance of the 19-mm St. Jude Medical Hemodynamic Plus aortic prosthesis (19HP), evaluated the midterm performance of 19HP in the aortic position, and compared the implantability and hemodynamic characteristics of this valve with those of the 21-mm standard St. Jude Medical valve (21SD) in adult patients with aortic stenosis and a narrowed aortic annulus. METHODS: From February 1994 to December 1999, 60 patients who underwent isolated aortic valve replacement with either the 19HP (n = 31) or the 21SD (n = 29) were studied. Comparison between the two models included analysis of early and late mortality and morbidity. Pre- and postoperative echocardiography was performed in all patients to evaluate and compare the hemodynamic performance of both prosthetic valves. The postoperative serum lactic dehydrogenase activity was measured in both groups of patients as an indicator of hemolysis. RESULTS: The mean body surface area was 1.46 +/- 0.16 m2 in the 19HP group and 1.49 +/- 0.13 m2 in the 21SD group (p = 0.1577). Other than female dominance in the 19HP group, there was no statistically significant difference between the two groups in terms of preoperative variables (age, preoperative pressure gradients, and New York Heart Association functional class). The average postoperative peak pressure gradient was 23.3 +/- 10.5 mm Hg in the 19HP group and 27.9 +/- 9.9 mm Hg in the 21SD group (p = 0.0666). There was no hospital death in either group. Six-year follow-up was completed in both groups of patients. Late death occurred in 1 patient in the 19HP group (1.09% per patient-year). Actuarial survival at 6 years was 92.3% +/- 7.4% in the 19HP group, and 100% in the 21SD group (p = 0.33). The linearized complication rate was 1.09% per patient-year and 1.02% per patient-year for thromboembolism, and 1.09% per patient-year and 1.02% per patient-year for anticoagulant-related hemorrhage in the 19HP group and the 21SD group, respectively. Freedom from all complications at 6 years did not show any significant difference between the two groups (p = 0.54). Although left ventricular mass indices decreased significantly after aortic valve replacement in both groups (19HP group, p = 0.0002; 21SD group, p = 0.0006), there were no significant differences in the two indices between the groups after aortic valve replacement (p = 0.999). There was no significant difference in the lactic dehydrogenase level between the two groups (p = 0.4915). CONCLUSIONS: In vivo hemodynamic performance of the 19HP valve as well as the early and intermediate clinical outcome up to 6 years was satisfactory and corresponded closely to that of the 21SD valve in adult patients. The 19-mm Hemodynamic Plus model can be recommended in patients with a measured 19-mm annulus and this valve will minimize the need for the aortic annular enlargement procedure.     

Aortic valve replacement with 17-mm St. Jude Medical Regent prosthetic valves for a small calcified aortic annulus in elderly patients

Purpose  

The aim of this study was to investigate the outcome of aortic valve replacement (AVR) performed with a 17-mm St. Jude Medical Regent prosthetic valve (17SJMR) for an aortic annulus ≤19 mm in elderly patients aged ≥65 years.