Mass regression in aortic stenosis after valve replacement with small size pericardial bioprosthesis

BACKGROUND: The aim of the study was to determine whether left ventricular mass regression is influenced by valve size after the implantation of a Carpentier-Edwards Perimount (CEP) pericardial bioprosthesis for pure aortic stenosis. METHODS: Patients receiving 19-mm, 21-mm, and 23-mm CEP aortic valves underwent echocardiography preoperatively and at least 1 year after surgery (mean, 2.3 +/- 1 years) and the echocardiograms were compared within and between groups. RESULTS: The study involved a total of 88 patients: 34 receiving 19-mm CEPs, 29 receiving 21-mm CEPs, and 25 receiving 23-mm CEPs. The mean postoperative prosthetic gradients were respectively 20.6 +/- 6.6 mm Hg, 17.9 +/- 5.8 mm Hg, and 13.2 +/- 4.1 mm Hg (p = 0.0001); the mean postoperative valve areas were respectively 1.24 +/- 0.16 cm(2), 1.45 +/- 0.2 cm(2), and 1.63 +/- 0.21 cm(2) (p = 0.0001). In comparison with the preoperative echocardiographic measurements absolute left ventricular mass significantly decreased by -54.1 +/- 48.8 g, -54.1 +/- 55.1 g, and -74.4 +/- 57.4 g respectively with no statistically significant between-group difference (analysis of variance) but ventricular septum and posterior wall thickness significantly decreased in each group (p < 0.05). CONCLUSIONS: The implantation of 19-mm, 21-mm, and 23-mm CEP aortic prostheses significantly reduces left ventricular mass without any size-related differences.     

Are mechanical valves with enhanced inner diameter advantageous in the small sized aortic annulus?

BACKGROUND: Mechanical bileaflet valves with enhanced inner diameter may offer superior hemodynamic properties in patients with a small aortic annulus. The aim of this clinical study was to compare these valves with standard bileaflet prostheses in vivo. METHODS: Mechanical aortic valve replacement for combined stenosis and regurgitation was performed in 47 patients with standard CarboMedics prostheses (CM: 21 mm, 23 mm, 25 mm) and two types of diameter enhanced St. Jude Medical prostheses (SJM-AHPJ: 21 mm, 23 mm, 25 mm; SJM-Regent: 21 mm, 23 mm). Transvalvular mean gradients (TVG) were assessed intraoperatively by means of transesophageal echocardiography (TVG(TEE)) and simultaneous direct pressure monitoring of the left ventricle and the ascending aorta (TVG(CATH)), as well as early (3 months) and late (9 months) postoperatively by means of transthoracic echocardiography (TVG(TTE)). Left ventricular muscle mass was assessed preoperatively, early, and late postoperatively to evaluate remodeling capacity. RESULTS: In all valve types and sizes, both TVG assessments exhibited consistent findings. Small-sized conventional valves of 21 mm showed a marked initial TVG. In contrast, both valve types with enhanced inner diameter exhibited significantly lower TVG comparable with those achieved with larger valves (TVG(CATH) CM 21 mm, 15.6 +/- 3.9 mm Hg; SJM-AHPJ 21 mm, 11.9 +/- 1.6 mm Hg; SJM-Regent 21 mm, 9.9 +/- 1.1 mm Hg; CM 23 mm, 7.8 +/- 0.8 mm Hg; SJM-AHPJ 23 mm, 7.7 +/- 1.4 mm Hg; SJM-Regent 23 mm, 9.5 +/- 1.8 mm Hg). During the postoperative course TVG remained constant in all valve types and sizes. Left ventricular muscle mass, however, diminished markedly in all valves without exhibiting significant differences between size matched valve types. CONCLUSIONS: In patients with a small aortic annulus, who require a 21-mm valve, diameter-enhanced prostheses provide lower transvalvular gradients than conventional valves. However, in the intermediate clinical course, appropriate left ventricular remodeling occurred in all patients independent of the size and the type of the valve.     

Hemodynamics and early clinical performance of the St. Jude Medical Regent mechanical aortic valve

BACKGROUND: The St. Jude Medical Regent valve is the next-generation bileaflet aortic prosthesis, modified from the currently marketed St. Jude Medical mechanical valve to achieve a larger geometric orifice without changing the existing design of the pivot mechanism or blood-contact surface areas. The present study reports the hemodynamic and early clinical results of an ongoing multicenter trial investigating the performance of the Regent valve. METHODS: Between July 1998 and July 2001, 361 patients at 17 centers in North America and Europe underwent implantation of a Regent mechanical aortic valve prosthesis. Clinical status was prospectively recorded, and echocardiography with Doppler was performed at discharge and at 2 months, 6 months, 1 year, and 2 years after operation. RESULTS: Follow-up to date is 300 patient-years (average, 0.8 +/- 0.7 years per patient; range, 0.0 to 2.7 years). There were low rates of clinical adverse events. Mean gradient at 6 months was 9.7 +/- 5.3 mm Hg, 7.6 +/- 5.2 mm Hg, 6.3 +/- 3.7 mm Hg, 5.8 +/- 3.4 mm Hg, and 4.0 +/- 2.6 mm Hg, respectively, for 19-mm, 21-mm, 23-mm, 25-mm, and 27-mm valves; effective orifice area was 1.6 +/- 0.4 cm2, 2.0 +/- 0.7 cm2, 2.2 +/- 0.9 cm2, 2.5 +/- 0.9 cm2, and 3.6 +/- 1.3 cm2, respectively. Indexed effective orifice area was equal to or greater than 1.0 cm2/m2 for all valve sizes. Left ventricular mass index decreased significantly between early postoperative (165.9 +/- 57.1 g/m2) and 6-month follow-up (137.9 +/- 41.0 g/m2; delta = -28.0 +/- 49.1 g/m2; p < 0.0001). CONCLUSIONS: The St. Jude Medical Regent aortic valve has excellent hemodynamics and early clinical results, with rapid and significant left ventricular mass regression. Long-term clinical assessment is ongoing.     

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.     

Rest and exercise hemodynamics following aortic valve replacement. A comparison between 19 and 21 mm Ionescu-Shiley pericardial and Carpentier-Edwards porcine valves

When aortic valve replacement is performed in a patient with a small anulus, significant obstruction of the left ventricular outflow tract may remain. Most prostheses are obstructive in the smaller sizes, and enlargement of the aortic anulus may be required to allow placement of a larger valve. To evaluate the hemodynamic performance of two commonly used tissue prostheses, the Ionescu-Shiley pericardial and Carpentier-Edwards porcine valves, 22 patients with either the 19 or 21 mm size were electively studied at rest and after exercise at a mean of 15 months after operation. The resting mean transvalvular gradient for 19 mm Ionescu-Shiley pericardial valves (n = 7), 10.6 +/- 9.2 mm Hg, was significantly lower than that for 19 mm Carpentier-Edwards valves (n = 3), 33.3 +/- 2.1 mm Hg, p less than 0.01. Following exercise, the mean gradient for 19 mm Ionescu-Shiley pericardial valves rose only to 13.8 +/- 8.5 mm Hg. No exercise data were available for the 19 mm Carpentier-Edwards valve. Among patients with 21 mm Ionescu-Shiley pericardial valves (n = 7), the mean transvalvular gradient at rest was 5.6 +/- 9.5 mm Hg, not significantly different from that of patients with 21 mm Carpentier-Edwards valves (n = 5), 9.8 +/- 18.3 mm Hg. After exercise, the gradients rose to 16.0 +/- 10.0 mm Hg and 25.5 +/- 23.8 mm Hg for the Ionescu-Shiley pericardial and Carpentier-Edwards valves, respectively (no statistical significance). Cardiac index was not different between groups. Gradients were not significantly higher in patients with body surface areas greater than 1.5 m2. It is concluded that the 19 and 21 mm Ionescu-Shiley pericardial valves possess excellent hemodynamics, even after exercise. This valve appears hemodynamically superior to the Carpentier-Edwards valve, particularly in the 19 mm size. Procedures to enlarge the aortic anulus are usually unnecessary when small Ionescu-Shiley pericardial valves are used, even in patients who have large body surface areas.     

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.     

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.     

Are stentless valves hemodynamically superior to stented valves? A prospective randomized trial

BACKGROUND: Although stentless aortic bioprostheses are believed to offer improved outcomes, hemodynamic benefits remain unsubstantiated. METHODS: Fifty-three patients were randomized to receive the stented C-E pericardial valve (CE) and 46 patients the Toronto Stentless Porcine valve (SPV). Annuli were sized for the optimal insertion of both valve types, such that surgeons were required to commit to specific valve sizes before randomization. Echocardiographic measurements and functional status (Duke Activity Status Index) were assessed at 3 and 12 months postoperatively. RESULTS: Although cardiopulmonary bypass times (CE: 118.6+/-36.3 minutes; SPV: 148.5+/-30.9 minutes; p = 0.0001) and aortic cross-clamp times (CE: 95.4+/-28.6 minutes; SPV: 123.6+/-24.1 minutes; p = 0.0001) were significantly prolonged in the SPV group, perioperative morbidity and mortality was similar between groups. Neither valve offered a superior internal diameter for any given annular diameter (mean decrease in left ventricular outflow tract diameter after valvular implantation: SPV: 3.4+/-1.11 mm versus CE: 3.7+/-1.33 mm; p = 0.25). Although labeled mean valve size was significantly larger in the SPV group, the actual mean valve size based on internal valvular diameter was no different between groups (CE: 21.9+/-2.0 mm; SPV: 22.3+/-2.0 mm; p = 0.286). Although effective orifice areas increased, and mean and peak transvalvular gradients decreased in both groups over time, no differences were demonstrated between groups at 12 months. Similarly, although significant regression of left ventricular mass was accomplished in both groups over time, no differences were demonstrated between groups. Finally, Duke Activity Status Index scores of functional status improved in both groups over time; however, no differences were noted between groups at 12 months postoperatively. CONCLUSIONS: Although offering excellent outcomes, stentless valves did not demonstrate superior hemodynamic indices in comparison to stented valves up to 12 months after implantation.     

Comparative rest and exercise hemodynamics of 23-mm stentless versus 23-mm stented aortic bioprostheses

BACKGROUND: The hemodynamic superiority of stentless valves at rest has been generally accepted, but there is a lack of studies on exercise hemodynamics. METHODS: We assessed aortic valve hemodynamics at rest and during exercise in 10 patients with a 23-mm stentless aortic bioprosthesis (Medtronic Freestyle; Medtronic Europe SA/NV, St. Stevens Woluwe, Belgium), in 10 patients with a 23-mm stented aortic bioprosthesis (Carpentier-Edwards, SAV, model 2650; Baxter Edwards AG, Horw, Switzerland), and in 10 healthy volunteers (control group) by means of Doppler echocardiography. RESULTS: Gradients at rest and gradients on comparable maximum exercise levels were significantly lower in patients with stentless valves compared to those with stented valves (rest: 6 +/- 2/11 +/- 4 mm Hg [mean/peak] versus 12 +/- 3/21 +/- 10 mm Hg; exercise: 9 +/- 3/18 +/- 6 mm Hg [mean/peak] versus 22 +/- 8/40 +/- 11 mm Hg). Patients with stentless valves revealed, in comparison to healthy young men, significantly higher gradients, but the small gradient difference of 3/7 mm Hg (mean/peak) at rest remained nearly unchanged throughout the exercise protocol (4/8 mm Hg [mean/peak] at 25 W, 4/9 mm Hg at 50 W and 4/9 mm Hg at 75 W). In contrast, the gradient difference between patients with stented and stentless valves increased significantly from one exercise level to the next (6/12 mm Hg [mean/peak] at rest, 8/14 mm Hg at 25 W, 12/17 mm Hg at 50 W, and 15/25 mm Hg at 75 W). CONCLUSIONS: A stentless aortic bioprosthesis seems to be an appropriate aortic valve substitute, especially in patients who perform regular physical exercise.     

Functional hemodynamic assessment of the 21-mm and 23-mm CarboMedics Top Hat aortic prosthetic valve

Between 1993 and 1996 the CarboMedics Top Hat supraannular aortic valve was implanted in 41 patients at the Wessex Cardiothoracic Centre (age, 39 to 74 years; mean, 61.3+/-8.9 years). Comparisons of annular dimensions made at surgery indicate that conventional annular valve replacement would have required at least a size smaller valve. This was particularly marked when a prosthetic mitral valve was in place. Operative mortality was 2.4%. There were also three late deaths. Echocardiography before and after symptom-limited treadmill testing has been performed in 21 patients. The mean time to follow-up was 16.1 months. The Doppler-derived indices of forward flow pre- and postexercise were expressed as mean+/-standard deviation. For 23-mm valves the values were: peak valve gradient 21.43+/-7.46 mm Hg and 35.86+/-14.4 mm Hg, aortic valve area 1.13+/-0.39 cm2 and 1.24+/-0.54 cm2. For 21-mm valves the values were: peak valve gradient 24.84+/-8.2 mm Hg and 31.29+/-5.84 mm Hg, aortic valve area 1.08+/-0.44 cm2 and 0.95 +/-0.2 cm2. The Top Hat valve has a good hemodynamic profile at rest and during exercise. Surgical considerations make it particularly useful in patients with a small aortic annulus and in patients undergoing combined aortic and mitral valve replacement.     

Influence of aortic valve replacement, prosthesis type, and size on functional outcome and ventricular mass in patients with aortic stenosis.

OBJECTIVES: Two years after surgery for severe aortic stenosis, we prospectively evaluated the influence of aortic valve replacement, as well as valve type (mechanical or stented biologic) and size, on functional status, left ventricular function, and regression of mass. METHODS: Patients who received either a mechanical (n = 95) or a biologic valve (n = 42) were studied by echocardiography before the operation and after 2 years. RESULTS: The percentage of patients with severe dyspnea decreased from 53% to 13% (P =.001). The cardiac index increased from mean 2.6 L/min per square meter (95% CI: 2.48-2. 72 L/min per square meter) to 3.1 L/min per square meter (95% CI: 2. 94-3.26 L/min per square meter; P =.001). The percentage of the patients with mild-to-moderate diastolic dysfunction decreased from 43% to 18% (P =.001). The left ventricular mass index was reduced by 42.4 g (95% CI: 35-50 g; P =.001). In comparison with biologic valves of the same size, mechanical valves produced a more pronounced reduction in mass index (overall difference 21.7 g; 95% CI: 37.1-6.4 g; P =.007) and a lower mean Doppler gradient (overall difference 4 mm Hg; 95% CI: 2-6 mm Hg; P =.0002). CONCLUSIONS: Patients undergoing aortic valve replacement had an improvement in functional status, as well as systolic and diastolic left ventricular function, and a reduction in left ventricular mass index, irrespective of prosthesis size and type. Mechanical valves are somewhat less obstructive than stented bioprosthetic valves of the same size. They are also associated with a concomitantly more pronounced reduction of left ventricular mass.     

Left ventricular outflow tract obstruction following mitral valve replacement: effect of strut height and orientation

The influence of strut position and strut height of Ionescu-Shiley bovine pericardial valves on the degree of left ventricular outflow tract (LVOT) obstruction was studied following mitral valve replacement (MVR) in hypertrophied left ventricles. Left ventricular hypertrophy was created in 6 lambs by constrictive banding of the descending thoracic aorta at 2 weeks of age. MVR was accomplished seven months later utilizing cardiopulmonary bypass and hypothermic cardioplegic arrest. Each animal underwent three consecutive valve replacements with 25-mm bovine pericardial valves randomly inserted in each of the following manners: (1) standard-profile valve with orientation of the struts out of the LVOT; (2) standard-profile valve with a strut oriented into the LVOT; and (3) low-strut profile investigational valve with a strut oriented into the LVOT. Gradients across the LVOT were measured after MVR and then following administration of isoproterenol hydrochloride (0.05 micrograms per kilogram of body weight per minute). No gradient was created with the struts oriented out of the LVOT with or without isoproterenol administration. When a strut was oriented into the LVOT without isoproterenol, the gradients were comparable with the standard- and low-profile valves (7 +/- 2 mm Hg versus 6 +/- 4 mm Hg, respectively). With isoproterenol, however, a significant difference in gradients between the standard- and low-profile valves (65 +/- 20 mm Hg versus 22 +/- 14 mm Hg, respectively) was observed when a strut was oriented into the LVOT. The results show that LVOT obstruction following MVR was related to the orientation of the strut of the bioprosthetic valve, and this obstruction was diminished with a decreased strut height of the Ionescu-Shiley prosthesis.     

Doppler Sonographic Evaluation of the CarboMedics Bileaf let Valve Prosthesis: One-Year Experience

Between April 1989 and March 1991, 237 CarboMedics bileaflet valve prosthesis carriers (165 aortic and 72 mitral valves, mean age 54.4 years) were studied prospectively with pulsed- and continuous-wave Doppler at a mean interval of 11.4 months following surgery in order to establish ranges of normal flow velocities and pressure gradients. Physical examination revealed no signs of prosthetic dysfunction or heart failure. Postoperative left ventricular function as measured by fractional shortening was 37% for aortic valve carriers and 30% for mitral valve carriers (p = NS). Mean peak velocity (+/- SD) across the aortic valve was 2.6 m/sec (+/- 0.4) and calculated instantaneous peak pressure gradient ranged from 11 to 58 mmHg (mean 28.1 +/- 10.3). It has to be emphasized that occasional patients with normally functioning valve prostheses can show unusual high gradients. Ring diameters between 21 and 27 mm showed no significant difference with regard to flow velocities and pressure gradients, whereas in 19-mm valves, significantly higher values could be demonstrated. The 123 aortic valve carriers with normal left ventricular function (fractional shortening greater than 25%) showed significantly higher pressure gradients than the 19 patients with reduced left ventricular function (28.6 +/- 11.6 mmHg vs 16.2 +/- 5.1 mmHg, p less than 0.05). In the mitral position, the mean of peak velocity (+/- SD) was 1.7 +/- 0.4 m/sec and pressure half-time was 108 +/- 26 msec, representing a calculated valve area between 1.4 to 3.1 cm2 (mean orifice size 2.1 +/- 0.5 cm2). No significant difference between valves of different sizes was found.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical and hemodynamic evaluation of the 19-mm Carpentier-Edwards supraannular aortic valve.

The clinical and hemodynamic performance of the 19-mm Carpentier-Edwards supraannular aortic valve is largely unknown compared with that of the larger valves. Over 4 years we implanted the 19-mm Carpentier-Edwards supraannular aortic valve into 21 patients (20 female) with a mean age of 75 +/- 1.2 years (range, 59 to 86 years) and a mean body surface area of 1.6 +/- 0.03 m2 (range, 1.3 to 1.7 m2). There were four deaths, one operative and three late noncardiac deaths. Follow-up of the 17 survivors for a mean of 20 +/- 3.1 months (range, 2 to 42 months) demonstrated symptomatic improvement in all 17 (all are now in New York Heart Association functional class I or II). There were no valve-related complications and no patient required long-term anticoagulation. Doppler echocardiographic studies were used to assess the in vivo hemodynamic profile of the valve. Mean postoperative aortic valve gradient was 34.1 +/- 2.7 mm Hg (range, 19 to 52 mm Hg). Functional valve orifice area was 1.1 +/- 0.09 cm2 (range, 0.6 to 1.8 cm2). Mean cardiac output was 3.92 +/- 0.17 L/min (range, 3.2 to 5.1 L/min) with a mean cardiac index of 2.5 +/- 0.11 L.min-1 x m-2 (range, 2.1 to 3.2 L.min-1 x m-2). In conclusion, we have demonstrated that aortic valve replacement with the 19-mm Carpentier-Edwards supraannular aortic valve has a low operative mortality and offers major clinical benefits despite moderate transprosthetic gradients. This approach provides an alternative management strategy in elderly patients who would otherwise require low-profile mechanical valves or aortic root enlargement.     

Characteristic resistance curves of aortic valve substitutes facilitate individualized decision for a particular type.

OBJECTIVE: Biological valves exhibit characteristic curves (CC) regarding transvalvular gradient, resistance, and effective orifice area when correlated with a physiological cardiac output range (CO). The slope of the curve of transvalvular resistance over a typical CO range characterizes the clinical performance of the valve. These information may support an individualized decision towards the most adequate valve type. METHODS: In an extracorporeal mock circuit two types of stented biological aortic valves (constructed pericardial valves, Edwards Perimount: EP; porcine cusp valves, Medtronic Mosaic: MM) of 21, 23, and 25 mm were investigated. Mean transvalvular gradient was measured over a range of 1.9 to 7.2l/min CO at a simulated heart rate of 70 beats/min. Transvalvular resistance was calculated and presented as characteristic curves in a log-log-plot against cardiac output. RESULTS: EP valves of all sizes demonstrated low slopes (resistance range; slope: 21 mm: 53-79 dynes s cm(-5); 0.29; 23 mm: 44-56 dynes s cm(-5); 0.12; 25 mm: 38-45 dynes s cm(-5); 0.12) while MM valves exhibited steep slopes (resistance range; slope: 21 mm: 46-169 dynes s cm(-5); 0.97; 23 mm: 36- -146 dynes s cm(-5); 0.95; 25 mm: 27-64 dynes s cm(-5); 0.68). CONCLUSIONS: While constructed pericardial valves demonstrate sufficient hemodynamic performance especially in the higher CO range porcine cusp valves exhibited minor resistance in the lower CO range. Patients who exercise regularly may therefore profit from a pericardial valve while patients with a small body surface area and little exercise who therefore remain in the lower CO range may be adequately treated with a porcine cusp valve.     

Clinical and hemodynamic performance of the Ionescu-Shiley valve in the small aortic root. Results in 117 patients with 17 and 19 mm valves

The Ionescu-Shiley pericardial valve was our bioprosthetic valve of choice between 1981 and 1985 for patients in whom the aortic anulus could not accept a valve larger than 19 mm in outer diameter or in whom the avoidance of warfarin sodium (Coumadin) was important. A series of 117 consecutive patients who received 17 or 19 mm valves for isolated aortic valve replacement or aortic valve replacement combined with coronary artery bypass grafting or other valvular procedures was analyzed. Overall, 74% of the patients were female, with a mean age of 70.9 years and a body surface area of 1.67 +/- 0.19 m2; 92.3% were in New York Heart Association class III-IV, and the operation was urgent or emergent in 46%. The operative mortality rate was 7.7%, with no deaths in patients undergoing isolated elective first-time aortic valve replacement. Mean follow-up for survivors was 2.5 years (10 to 62 months). There were 20 late deaths, of which three were valve related, three were due to sudden death or arrhythmias, and two were due to persistent heart failure. The actuarial survival rate at 5 years was 68%. Clinical follow-up revealed a low incidence of valve-related complications, and 96.4% of survivors were in class I-II. Postoperative echocardiography before hospital discharge revealed a maximum instantaneous gradient of 18.4 +/- 3.0 mm Hg in five patients having a 17 mm valve and 31.3 +/- 12.7 mm Hg in 20 patients having a 19 mm valve. Doppler echocardiography was performed in 22 patients at a mean follow-up of 39.3 +/- 11.7 months. The maximum instantaneous gradient was 25 +/- 17.2 mm Hg for 17 mm and 17.41 +/- 5.4 mm Hg for 19 mm valves at late follow-up. The effective orifice area was 0.85 +/- 0.1 cm2 for 17 mm and 1.21 +/- 0.21 cm2 for 19 mm valves. This study defines the normal range of Doppler echocardiographic transprosthetic gradients for the Ionescu-Shiley valve and confirms that low operative mortality and excellent clinical improvement can result from the use of small Ionescu-Shiley valves in elderly patients despite moderate postoperative transvalvular gradients.     

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.     

Hydrodynamic function of the second-generation mitroflow pericardial bioprosthesis

BACKGROUND: The hydrodynamic function of the smaller size Mitroflow Synergy stented pericardial bioprostheses has been studied in an in vitro fresh tissue aortic root model and compared with previous studies of free-sewn bioprostheses. METHODS: Three valves of each of the sizes 19, 21, and 23 mm were sutured into fresh tissue aortic roots and tested in a pulsatile flow simulator using two different ventricular input impedance conditions. A high-speed camera was used to study the leaflet opening and closing configurations. Mean pressure difference as a function of root mean square forward flow, effective orifice area, regurgitant volumes, and total energy loss across the valves was measured. RESULTS: Mean pressure difference with respect to root mean square forward flow decreased as the valve size increased. Thus effective orifice area increased as the valve size increased. The open leaflet configuration images showed that all three sizes of Mitroflow valves had a large circular orifice with minimal open leaflet deformation. All valves closed competently with no visible leakage and no closed regurgitant volume. The Mitroflow valves showed better effective orifice areas compared with previously tested frame-mounted porcine bioprostheses but lower effective orifice areas compared with porcine stentless bioprostheses; however, the open leaflet bending deformation was better than for any of the previously tested bioprosthetic valves. CONCLUSIONS: The hydrodynamic function of the Mitroflow Synergy stented pericardial bioprosthesis shows potential for good in vivo hemodynamic performance. The good hemodynamic performance combined with relative ease of implantation technique makes the pericardial valve a good valve in the aortic position, particularly in older patients with small annuli.     

Clinical and hemodynamic evaluation of small Perimount aortic valves in patients aged 75 years or older

BACKGROUND: There is the potential for iatrogenic aortic stenosis and poor quality of life when small aortic valve bioprostheses are used in elderly patients. The alternative is enlarging the aortic annulus to accommodate larger size prostheses, increasing operative mortality. It was hoped that bovine pericardial valves would improve hemodynamic performance in the smaller valve sizes. METHODS: To determine long-term results and in vivo hemodynamic performance of small-size aortic Carpentier-Edwards bovine pericardial valves (Perimount) in elderly patients, we analyzed our follow-up and echocardiographic data from patients 75 years of age or older receiving isolated 19-mm and 21-mm Perimount valves. Ninety-four patients with a mean age of 77 +/- 2.2 years were followed for 12 years. Seventeen patients with 19-mm and 25 patients with 21-mm Perimount valves underwent transthoracic echocardiograms. RESULTS: Operative mortality was 6.3% (6 of 94). Twelve-year survival was 82.7%. Freedom from thromboembolism was 86.9% at 12 years. Two patients had anticoagulation-related bleeding. Overall New York Heart Association class decreased from 3 +/- 1 to 1.6 +/- 0.7 at the end of follow-up. Hemodynamic performances were satisfactory in both 19-mm and 21-mm Perimount valves, with low peak and mean transvalvular gradients and good effective orifice areas, orifice area indices, and performance indices. CONCLUSIONS: Perimount aortic valve in the small aortic annulus has yielded excellent long-term results and hemodynamic performances. Perimount is a very satisfactory option in elderly patients. Implantation of a Perimount bioprosthesis avoids enlargement of the small aortic annulus, reducing mortality and morbidity associated with this procedure.     

Medium-term determinants of left ventricular mass index after stentless aortic valve replacement

BACKGROUND: This study aimed to investigate the risk factors for elevated left ventricular mass index 3 to 5 years after stentless aortic valve replacement, and to elucidate the underlying physiologic mechanisms. METHODS: Eighty-nine patients (age, 76 +/- 6 years, 51 males) having a stentless porcine valve for aortic stenosis (n = 76) or regurgitation (n = 13) were prospectively studied by Doppler echocardiography 3 to 5 years after operation. Left ventricular systolic function, mass index, blood pressure, cardiac rhythm, and New York Heart Association function class were all determined. Stentless valve effective orifice area, mean pressure drop, and the presence and degree of aortic regurgitation were quantified. RESULTS: The mean stentless aortic valve size was 24 +/- 2 mm. At follow-up time of 45 +/- 9 months, effective orifice area index was 1.2 +/- 0.35 cm2 x m(-2), and mean pressure drop was 5.7 +/- 3.8 mm Hg. Left ventricular mass index was 128 +/- 47 g x m(-2), and ejection fraction was 63% +/- 14%. Multivariant analysis showed a greater left ventricular mass index to be associated with nonsinus rhythm (versus sinus) (163 +/- 8 versus 131 +/- 7 g x m(-2)), greater pulse pressure (> 84 mm Hg) (161 +/- 7 versus 133 +/- 7 g x m(-2)), New York Heart Association class II or III (versus class I) (166 +/- 10 versus 128 +/- 5 g x m(-2)), and male sex (versus female) (160 +/- 7 versus 134 +/- 8 g x m(-2)), all p < 0.01. Mean pressure drop (> 8 mm Hg), effective orifice area index (< 1.0 cm2 x m(-2)), the presence of mild regurgitation of the stentless valve, or the type of previous valve disease were insignificant determinants of left ventricular mass index. CONCLUSIONS: Three to five years after the implantation, stentless aortic valve hemodynamics remain excellent. Left ventricular hypertrophy caused by previous native aortic valve disease had largely regressed. However, patient-related factors, particularly systemic blood pressure, cardiac rhythm, and function, are significant causes of late residual left ventricular hypertrophy. Thus, continued medical care and earlier surgical intervention may further improve the outlook for these patients.