Jude Valve Research Articles

Microbubbles and mitral valve prostheses — transesophageal echocardiographic evaluation

Objective: To assess whether microbubbles are associated with a specific type of mitral valve prosthesis and to investigate the relationship of microbubbles to ventricular function and mitral regurgitation. One of the types of spontaneous echocardiographic contrast observed in patients with prosthetic heart valves has been described as microbubbles. Methods: Clinical data and videotapes of patients with a prosthetic mitral valve who had undergone transesophageal echocardiography at the UCLA Medical Center between May 1989 and February 1995 were retrospectively reviewed. There were 109 studies (74 patients) available for review by two independent observers. Results: Microbubbles occurred in 49 of the 66 studies of St. Jude valves ( 74%), eight of the 12 studies of Bjork Shiley valves (67%), four of four studies of Medtronic valves (100%) and zero of 23 studies of tissue valves (0%). Patients with an estimated ejection fraction greater than 45% were found to have a much higher likelihood of having microbubbles observed. There was no statistically significant association between the degree of mitral regurgitation and the observation of microbubbles. Conclusions: Microbubbles are a common phenomenon occurring in patients with mechanical mitral prostheses compared with tissue mitral valve prostheses. Their formation depends on the systolic ventricular function, suggesting a cavitation-like phenomenon participating in their formation perhaps due to the rate or velocity of the valve closure.

Hemodynamic performance of four mechanical bileaflet prosthetic valves in the mitral position: an echocardiographic study

Objectives: The CarboMedics, Duromedics, Sorin Bicarbon and the St. Jude Medical valves are bileaflet mechanical prostheses of modern but different design. Choosing a valve with the best hemodynamic profile is of clinical importance in patients with small ventricles and a small mitral annulus. Methods: The hemodynamic performance of these valves in the mitral position was compared in 76 asymptomatic, ambulatory patients with normally functioning prosthesis and left ventricle, using Doppler echocardiography. Of the 76 patients studied, 22 had the CarboMedics, 16 had the Duromedics, 17 had the Sorin Bicarbon and 21 had the St. Jude prosthesis. The patients ages ranged from 18 to 81 years. There were 44 women and 32 men. The time from implantation to echocardiographic study ranged from 1 to 55 months. Results: The echocardiographic study was performed earlier after surgery in the Sorin Bicarbon group. There was no significant difference in women/man ratio, incidence of atrial fibrillation, left ventricular or left atrial diameters between the four groups. The mean prosthesis size was significantly smaller for Sorin Bicarbon and Duromedics valves compared to the CarboMedics and the St. Jude valves (mean±SD, 27.2±1.3, 27.1±1.1 and 30.0±1.9 and 30.0±2.7 mm, respectively, P<0.001). Despite its smaller size the Sorin Bicarbon valve had significantly larger effective valve area by Doppler compared to the CarboMedics valve (290±40 vs 250±60 mm 2, respectively, P=0.014). The ratio of effective valve area to prosthesis size was significantly larger for the Sorin Bicarbon valve when compared with any other type of prosthesis. Conclusions: (1) The Sorin Bicarbon bileaflet valve offered the best hemodynamic results that may be explained by the valve's large leaflet opening angle and small thickness of the leaflets. (2) Since the Sorin Bicarbon is the newest bileaflet valve, durability of this valve remains uncertain.

Antithrombotic Therapy in Patients With Mechanical and Biological Prosthetic Heart Valves

Permanent therapy with oral anticoagulants offers the most consistent protection in patients with mechanical heart valves. Antiplatelet agents alone do not consistently protect patients with mechanical prosthetic heart valves, including patients in sinus rhythm with St. Jude valves in the aortic position. Levels of oral anticoagulants that prolong the INR to 2.0 to 3.0 appear satisfactory for patients with bileaflet mechanical valves in the aortic position, provided they are in sinus rhythm and the left atrium is not enlarged. Oral anticoagulant levels that prolong the INR to 2.5 to 3.2 are satisfactory for patients with bileaflet mechanical aortic valves and atrial fibrillation. Oral anticoagulant levels that prolong the INR to 2.5 to 3.5 are satisfactory for tilting disk valves and bileaflet prosthetic valves in the mitral position. Experience is sparse in patients with caged ball valves who had prothrombin time ratios reported in terms of INR. It has been suggested that the most advantageous INR level in patients with caged ball or caged disk valves should be as high as 4.0 to 4.9. However, others have shown a high rate of major hemorrhage with an INR that is even somewhat lower (3.0 to 4.5). The problem is self-limited, however, because few such valves are being inserted. Aspirin, in addition to oral anticoagulants, in patients with mechanical heart valves has been shown to diminish the frequency of thromboemboli. The risk of bleeding may not be increased if the INR is low. A low rate of both thromboemboli and bleeding has been shown with an INR of 2.5 to 3.5 in combination with aspirin at a dose of 100 mg/d. There are no investigations in which an aspirin dose of 81 mg/d in combination with oral anticoagulants was evaluated. Dipyripdamole may be effective in reducing the rate of thromboemboli without increasing the rate of bleeding, but data are insufficient to recommend dipyridamole over low doses of aspirin. Patients with bioprosthetic valves in the mitral position, as well as patients with bioprosthetic valves in the aortic position, may be at risk for thromboemboli during the first 3 months after surgery. Among patients during the first 3 months after surgery with bioprosthetic valves in the mitral position, oral anticoagulants administered at an INR of 2.0 to 2.3 were as effective as at an INR of 2.5 to 4.5: additionally, fewer bleeding complications were seen.

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.

Application of color Doppler flow mapping to calculate orifice area of St Jude mitral valve.

The effective orifice area (EOA) of a prosthetic valve is superior to transvalvular gradients as a measure of valve function, but measurement of mitral prosthesis EOA has not been reliable. In vitro flow across St Jude valves was calculated by hemispheric proximal isovelocity surface area (PISA) and segment-of-spheroid (SOS) methods. For steady and pulsatile conditions, PISA and SOS flows correlated with true flow, but SOS and not PISA underestimated flow. These principles were then used intraoperatively to calculate cardiac output and EOA of newly implanted St Jude mitral valves in 36 patients. Cardiac output by PISA agreed closely with thermodilution (r=0.91, Delta=-0.05+/-0.55 L/min), but SOS underestimated it (r=0.82, Delta=-1.33+/-0.73 L/min). Doppler EOAs correlated with Gorlin equation estimates (r=0.75 for PISA and r=0.68 for SOS, P<0.001) but were smaller than corresponding in vitro EOA estimates. Proximal flow convergence methods can calculate forward flow and estimate EOA of St Jude mitral valves, which may improve noninvasive assessment of prosthetic mitral valve obstruction.

Impact of size mismatch and left ventricular function on performance of the St. Jude disc valve after aortic valve replacement

The hemodynamic function of the St. Jude valve may change relative to changes in left ventricular function after aortic valve replacement for aortic stenosis. From theoretical reasons one may hypothesize that prosthetic valve hemodynamic function is related to left ventricular failure and mismatch between valve size and patient/ventricular chamber size. Forty patients aged 24 to 82 years who survived aortic valve replacement for aortic stenosis with a standard St. Jude disc valve (mean size, 23.5 mm; range, 19 to 29 mm) were followed up prospectively with Doppler echocardiography and radionuclide left ventriculography preoperatively and 9 days, 3 months, and 18 months after the operation with assessment of intravascular hemolysis at 18 months. Follow-up to a maximum of 7.4 years (mean, 6.3 years) was 100% complete. Left ventricular muscle mass index decreased from 198 +/- 62 g.m-2 preoperatively to 153 +/- 53 g.m-2 at 18 months (p < 0.001), paralleled by a significant increase in left ventricular ejection fraction, peak ejection rate, and peak filling rate; only 18% of the patients had normal left ventricular muscle mass index and only 32% normal ventricular function (normal left ventricular ejection fraction, peak ejection rate, peak filling rate, early filling fraction, and late filling fraction during atrial contraction) at 18 months. Prosthetic valve peak Doppler gradient dropped from 20 +/- 6 mm Hg at 9 days to 17 +/- 5 mm Hg at 18 months (p < 0.05). Reduction of left ventricular muscle mass index was unrelated to peak gradient and size of the valve. Peak gradient at 18 months rose with valve orifice diameter of 17 mm or less (by 6 mm Hg), orifice diameter/body surface area of 9 mm.m-2 or less (by 5 mm Hg), left ventricular enddiastolic dimension (by 23 mm Hg per 10 mm increase), and impaired ventricular function (by 3 mm Hg). All but 2 patients (5%) had intravascular hemolysis; none had anemia. Two patients with moderate paravalvular leak had the highest serum lactic dehydrogenase levels; 4 patients with trivial leak had higher serum lactic dehydrogenase levels than those without leak. Serum lactic dehydrogenase levels rose with moderate paravalvular leak, impaired ventricular function, and valve orifice diameter. Six patients with trivial or moderate paravalvular leak had a cumulative 7-year freedom from bleeding and thromboembolism of 44% +/- 22% compared with 87% +/- 5% for those without leak (p < 0.05). The peak gradient of the St. Jude aortic valve dropped marginally over the first 18 postoperative months in association with incomplete left ventricular hypertrophy regression and marginal improvement of ventricular function. Mismatch between valve size and ventricular cavity size or patient size and impaired function of a dilated ventricle significantly compromised the performance of the St. Jude valve. Probably explained by platelet destruction or activation, paravalvular leak was related to bleeding and thromboembolic complications.

Pressure Recovery Across The Aortic Valve

SummaryThe Bernoulli equation relates the pressure exerted on a fluid to its flow velocity and its density, in addition to its How acceleration and its viscous friction loss. When flow velocity increases at a narrowing, the local pressure decreases proportionally. It has been wrongfully assumed that pressure lost distal to a stenosis can never recover. It is, however, the energy content of the fluid, equal to the kinetic plus the potential energy, which can not increase. When flow slows distal to a narrowing and little energy is lost to friction, pressure does actually increase. Pressure recovery has been well demonstrated to exist in a variety of pathophysiological states. Bicuspid aortic valve prostheses such as the St. Jude valves can produce quite remarkable pressure recovery. This causes a great discrepancy between pressure drop calculations based on continuous wave doppler on the one hand and true pressure drop across the prosthesis on the other. Reliance on doppler measurements only might wrongfully lead one to conclude that the prosthesis was malfunctioning. Less extreme pressure recovery is possible across a stenotic native aortic valve, but interpretation of the flow velocity across the valve might make the difference between recommendations to replace or to retain the valve. When interpreting doppler signals across narrowings the phenomenon of pressure recovery should be kept in mind.

Is a bioprosthesis preferable in tricuspid valve replacement?

We reviewed clinical data on 29 patients (17 acquired disease and 12 congenital disease) who underwent tricuspid valve replacement using a Carpentier-Edwards porcine valve or a St. Jude Medical valve at Niigata University Hospital between January 1978 and October 1995, and analyzed risks related to the outcome. Age ranged from 8 to 62 years, and 17 females were included. New York Heart Association functional class was IV in 9 patients (31%). Previous valve surgery had been performed in 10 patients (34%). An urgent surgery was required in 4 patients and simultaneous mitral (with aortic) valve replacement in 13 (45%). Mean follow-up period was 6.7 years. Hospital mortality occurred in 5 patients (17.2%) and all of them had acquired valvular diseases with functional class IV. There were 6 late deaths and none of them related to the tricuspid prosthesis. Nonfatal morbidity occurred in 2 patients (a thrombosed valve and a chronic hemolytic anemia) with a St. Jude valve. Late functional class was I or II in all patients except 3 with severe left-ventricular dysfunction or bioprosthetic failure. Late postoperative echocardiographic examination showed moderate tricuspid stenosis or regurgitation in 3 patients with a Carpentier-Edwards valve. By the Kaplan-Meier method, functional class (P < 0.01) and baseline diseases (p < 0.05) were found to affect probability of freedom from cardiac- and/or valve-related mortality including hospital death. In conclusion, the present study indicates that similarly good outcome would be expected whether using a St. Jude Medical valve or a Carpentier-Edwards porcine valve, and that both functional class IV and combined acquired valvular disease are risk factors for mortality after tricuspid valve replacement. Patient-specific selection of the prosthesis would be preferable in tricuspid valve replacement.

Ale finite element analysis of the opening and closing process of the artificial mechanical valve

Employing arbitrary Lagrangian-Eulerian (ALE) finite element method, this paper studies the opening and closing process of a St. Jude medical valve through a two-dimensional model of the mechanical valve—blood interaction in which the valve is regarded as a rigid body rotating around a fixed point, and the blood is simplified as viscous incompressible Newtonian fluid. The numerical analysis of the opening and closing behaviour of as St. Jude valve suggested that: 1. The whole opening and closing process of an artificial mechanical valve is consisted of four phases: (1)Opening phase; (2) Opening maintenance phase; (3) Closing phase; (4) Closing maintenance phase. 2. The St. Jude medical valve closes with prominent regurgitat which results in water-hammer effect. 3. During the opening and closing process of the St. Jude valve, high shear stresses occur in the middle region of the two leaflets and on the valve ring. The present model has made a breakthrough on the coupling computational analysis considering the interactive movement of the valve and blood.

Pressure recovery in bileaflet heart valve prostheses. Localized high velocities and gradients in central and side orifices with implications for Doppler-catheter gradient relation in aortic and mitral position.

We investigate pressure recovery in central and side orifices of St Jude valves and the effect of mitral versus aortic position on the relation between Doppler- and catheter-derived pressure gradients. Maximum, transvalvular, and net pressure gradients are calculated and compared with Doppler-derived gradients in an in vitro model. Pressure recovery and pressure loss coefficients are calculated. Simultaneous Doppler and catheter gradients are obtained intraoperatively in five patients undergoing mitral valve replacement. Centerline Doppler gradients correspond closely with maximum catheter gradients but are higher than transvalvular and net pressure gradients. Thirty-six percent of the initial pressure drop is recovered between the valve leaflets and is independent of valve size or configuration. A variable amount of postvalvular pressure recovery is observed depending on aortic or mitral configuration. Side orifice velocities are 85 +/- 4% of the centerline velocities. Incorporation of the pressure loss coefficient in the simplified Bernoulli equation shows close agreement between centerline Doppler gradients and transvalvular gradients (r = .99, y = 1.11x-0.19). Gradients across the St Jude valve measured by Doppler ultrasound are higher than transvalvular or net catheter gradients due to downstream pressure recovery. This is more marked for Doppler gradients based on centerline velocities than side orifice velocities and is more pronounced for valves in an aortic than a mitral configuration. Therefore, to be comparable with invasive transvalvular catheter gradients, either Doppler gradients should be calculated based on side orifice velocity measurements or the Doppler gradient calculation should include the pressure loss coefficient when based on central orifice velocities.

Evolution of the surgical approach for replacement of degenerated mitral bioprostheses

Primary tissue failure is the most frequent indication for reoperation in patients with a mitral bioprosthetic valve (MBPV). Complete excision of the bioprosthesis is time-consuming and may be complicated by cardiac rupture at the atrioventricular junction or the posterior left ventricular wall where a strut is embedded, injury to the circumflex coronary artery, or late perivalvular leak. A new approach to avoid these complications by excision of only the bioprosthetic tissue and attachment of a St. Jude valve (SJV) to the intact stent has been developed and evaluated. The results of replacement of failed MBPV with SJV in 71 consecutive patients between September 1992 and December 1994 were analyzed; 57 patients had the valve replaced after complete excision and 14 with stent preservation. The demographic and clinical profiles of the two groups were similar. Among patients undergoing complete excision of the MBPV, operative mortality was 14% (8 of 57), with 12 late deaths and a 5-year survival of 75% and three late perivalvular dehiscences requiring another operation. No operative deaths occurred in the intact stent group and one late death (cancer), and all the remaining patients are doing well without perivalvular leaks or other complications. Leaving the MBPV stent intact eliminates the need for extensive dissection, thus shortening and simplifying the procedure and diminishing its attendant mortality and morbidity. It offers a safe and logical approach to replacement of a degenerated MBPV with a SJV of comparable size.

Mechanical versus biological valve prosthesis: A ten-year comparison regarding function and quality of life

To determine the long-term outcome of biological and mechanical heart valve prostheses, we compared the Biocor, a new generation of porcine bioprosthesis, with the St. Jude Medical mechanical prosthesis. One hundred consecutive patients operated on between 1983 and 1985 with the Biocor in the aortic, mitral, or both positions (without concomitant cardiac procedures) were followed until January 1993, together with 100 matched patients implanted with the St. Jude valve. The mean age was 66 and 67 years, respectively. The follow-up was 100% complete. Valve-related mortality differed significantly, with a freedom rate of 80.7% +/- 9.0% for the St. Jude group and 97.7% +/- 1.6% for the Biocor group. There were few thromboembolic events, with no significant difference between the groups. Anticoagulant-related hemorrhage occurred almost exclusively in the St. Jude group (2.3%/patient-year), and reoperations were required almost exclusively in the Biocor group (1.8%/patient-year). The occurrence of all valve-related complications (mortality plus morbidity) differed markedly, with an actuarial freedom at 10 years of 55.8% +/- 9.8% for St. Jude and 80.0% +/- 4.4% for the Biocor. Quality of life and echocardiographic measurements did not differ significantly between the groups. We conclude from this study that the long-term performance of the Biocor and St. Jude are comparable, even though valve-related complications tended to be fewer in the Biocor group, with a significantly lower incidence of valve-related death.

Double-valve replacement with Medtronic-Hall or St. Jude valve

To define better the performance of the bileaflet St. Jude and the tilting-disc Medtronic-Hall valves, we retrospectively analyzed 122 patients (St. Jude, 80 patients; Medtronic-Hall, 42 patients) who received simultaneous aortic and mitral replacement from May 1984 until June 1994. The two groups were not different with respect to preoperative clinical and hemodynamic parameters and New York Heart Association functional class. The hospital mortality and late mortality were not significantly different. Risk analysis identified advanced age and previous myocardial revascularization as predictors of operative death. Follow-up was complete in 96 of 103 hospital survivors (93%) and was similar in both groups. The actuarial survival, linearized rates of valve-related complications, and actuarial freedom from valve-related complications were similar in both cohorts. The presence of coronary artery disease negatively influenced the actuarial survival after simultaneous aortic and mitral valve replacement. Postoperative New York Heart Association functional class was not significantly different in either group. These data indicate that the Medtronic-Hall and St. Jude prostheses are not significantly different with respect to their clinical performance and valve-related complications for simultaneous double-valve replacement.

813-4 A New Surgical Approach for Replacement of Degenerated Mitral Bioprostheses

Primary tissue failure is the most frequent indication for reoperation in patients with a porcine bioprosthetic valve (BPV). Technical hazards of this operation include cardiac rupture at the atrio-ventricular junction or posterior left ventricular wall where a strut may be imbedded, damage to the left circumflex coronary artery during removal of the degenerated BPV and insertion of a new prosthesis, and the potential development of a late paravalvular leak. We describe a new surgical technique that circumvents these problems. It consists of 1) excision of only the cusp tissue of the BPV; 2) preservation of the stent and support of the BPV; 3) suturing a reverted St. Jude aortic valve with extended cuff to the atrial side of the preserved BPV cuff. Our laboratory measurements and clinical experience indicate that this allows a St. Jude valve diameter only 2 mm smaller than that of the BPV This particular approach was used in 13 patients, age 59 to 84 (mean 73) years, who had one to four (mean 2.3) previous cardiac operations. There were no hospital deaths. During a mean follow-up of 18 months (2–36). there was one late death due to cancer. All the remaining patients are doing well without paravalvular leaks or other complications. By leaving the BPV stent and cuff intact. the need for extensive dissection is eliminated, thus shortening and simplifying the procedure and diminishing its attendant morbidity. The described technique offers a safe and logical approach to patients requiring replacement of a degenerated BPV and allows the use of a St. Jude valve of comparable size to the BPV.

987-102 Proximal Flow Convergence Calculation of Forward Flow and Valve Area of Normal Mitral Prostheses: An Intraoperative Validation

We have previously shown in vitro that the proximal flow convergence method (FC) can be used to calculate flow through larger orifices such as normal prosthetic heart valves. To validate FC clinically, we performed intraoperative transesophageal echocardiography on 22 patients (mean age 63 ± 8 yrs, 64% female) undergoing mitral valve replacement with St Jude valve (n = 17) or Carpentier-Edwards valve (n = 5). For St Jude prostheses, peak velocities and velocity integrals through the center (V c and TVI c , respectively) and side (V s and TVI s ) orifices were interrogated separately with CW Doppler. As our in vitro model suggested about 80% of flow occurred through the side orifices, the corrected peak Velocity (V o ) is given by V o = 0.8V s + 0.2V c and the corrected velocity integral (TVI o ) by TVI o = 0.8TVI s + 0.2 TVI c . The flow rate (Q) was calculated by Q = 2 π r 2 V a where Va is the aliasing velocity. Q was multiplied by V o /(V o -V a ), a previously validated factor, to account for flattening of isotachs near the prosthetic orifice. Cardiac output (CO) calculated by (Q c * TVIo/V o ) * HR showed good correlation with thermodilution CO (Range 3.3–8.1 I/min, y = 0.87x + 0.67, r = 0.9, p &lt; 0.001, ΔCO = -0.02 ± 0.5 I/min). Effective prosthetic orifice area (EOA) of St Jude valves, given by Q c /V o , correlated well with geometric orifice area (GOA) from the manufacturers (r = 0.7, p = 0.002, y = 1.42x + 1.47). However, calculated EOA is significantly smaller than the GOA (ΔMVA = -2.23 ± 0.49 cm 2 , p &lt; 0.01) The proximal flow convergence method can give reliable in vivo estimates of 1) forward flow through normal mitral prostheses and 2) EOA of St Jude valves. The EOA of St Jude valve in vivo is significantly smaller than its GOA.

The effect of pathophysiology on the surgical treatment of ischemic mitral regurgitation: operative and late risks of repair versus replacement

Operative correction of ischemic mitral regurgitation (IMR) is associated with high risk approach. The objective of this retrospective study was to examine the interaction between the various underlying pathophysiologic mechanisms, the operative procedure, and their influence on short- and long-term outcomes. Over a 10-year period starting January 1984, mitral valve repair or replacement was performed on 150 patients with IMR. The age range was 42-86, mean 67, years; 71 (47%) were females; 139 (93%) were in NYHA functional class III or IV; 23 (15%) were reoperations; and 30 (20%) were in atrial fibrillation. Functional IMR due to annular dilatation or restrictive leaflet motion was present in 106 (71%), and structural IMR due to ruptured chordae or papillary muscle in 44 (29%). Mitral valve repair was performed in 94 (63%) with an annuloplasty ring employed in 80 (85%) patients. Mitral valve replacement was performed in 56 (37%), with 40 (71%) receiving a bioprosthesis (32 Hancock and 8 Carpentier-Edwards valves) and 16 (29%) a St. Jude valve. Coronary artery bypass graft surgery was performed in 139 (93%) patients. The overall operative mortality (OM) was 14/150 (9.3%). The OM for repair was 9.5% compared to 8.9% for replacement (P = NS). There was higher OM in the elderly, particularly in the repair group (P = 0.053), and a trend towards reduced OM in the recent years of the study (P = NS). No predictors of OM were identified by multivariate logistic regression analysis. Long-term follow-up was 98% complete and ranged from 2-120, mean 31.2, months for a total of 935 patient-years. The overall 5-year survival rate was 71 +/- 6%, with 91 +/- 5% for the replacement group compared to 56% +/- 10% for the repair group (P = 0.01). The functional subset of IMR who had a repair had the worse long-term survival (43 +/- 13%) compared to the structural/repair (76 +/- 13%) and structural/replacement groups (89 +/- 8%), and 92 +/- 7% for the functional/replacement group ((P = 0.0049). Multivariate logistic regression analysis identified the functional/repair group (hazards ratio 4.4; +/- 95%, confidence interval 1.6, 11, (P = 0.0031); and earlier years of surgery (hazards ratio 4.7; +/- 95% confidence interval 1.021; (P = 0.046) to be predictors of worse long-term survival. These results suggest that, in IMR, the underlying responsible pathophysiologic mechanisms appear to be the major determinants of survival, rather than the choice of the operative procedure.

Left ventricular outflow tract obstruction and hemolytic anemia after mitral valve repair with a duran ring

We report a case of mitral valve repair with a Duran ring that was complicated by left ventricular outflow tract obstruction, mitral regurgitation, and hemolytic anemia. A 59-year-old man with severe mitral valve regurgitation underwent mitral valve repair, including a Duran ring annuloplasty. Postoperatively, left ventricular outflow tract obstruction developed and echocardiography revealed severe systolic anterior motion of the mitral valve. The patient then underwent mitral valve replacement with a 29-mm St. Jude valve.

The risk of small St. Jude aortic valve prostheses

We reviewed our 12-year experience with 254 adult patients who had St. Jude valves in the aortic position and used multivariate analysis to examine risk factors possibly affecting long-term morbidity and mortality. Nineteen-millimeter or 21-mm valves were implanted in 115 patients. Poor preoperative congestive heart failure status was associated with persistent congestive heart failure on late foliow-up. Preoperative congestive heart failure and coronary artery disease were the only predictors of overall late death. Late deaths associated with heart failure and late sudden deaths were examined separately. Preoperative degree of heart failure was the only predictor of late death with associated heart failure. The implantation of a 19- or 21-mm valve in patients with a body surface area greater than 1.9 m 2 somewhat increased the risk of late sudden death. In patients with a body surface area greater than 1.9 m 2 and with a 19-mm or 21-mm annulus, consideration should be given to using a high-performance St. Jude valve or performing an annulus-enlarging procedure if this can be done with negligible morbidity.

St. Jude prosthesis for aortic and mitral valve replacement: A ten-year experience

From January 1, 1979 through December 1990, 456 adult patients underwent isolated aortic (AVR) (254) or mitral (MVR) (202) valve replacement with the St. Jude prosthesis at the Medical University of South Carolina. Age ranged from 21 to 84 years (mean: 54 ± 15 years for AVR; 51 ± 13 years for MVR). Male sex predominated in the AVR group (66%) and female sex in the MVR group (64%). Ninety-two patients (20%) had associated coronary artery bypass grafting (AVR, 25%; MVR, 14%). There were 17 deaths (3.7%) occurring during the same hospitalization or within 30 days (AVR, 10/254 [3.9%]; MVR, 7/202 [3.5%]). Follow-up is 94.5% complete and ranges from 1.0 to 131 months (mean, 55 ± 37 months; total, 2,073 patient-years). In the AVR group, 53 late deaths have occurred and actuarial survival is 80% ± 3% at 5 years and 47% ± 9% at 10 years. Twenty-one patients have sustained thromboembolic episodes (1.8%/patient-year), and the probability of remaining free of thrombo-embolism at 10 years is 67% ± 13%. The mean improvement in New York Heart Association functional class from preoperative to postoperative is 3.1 ± 0.76 to 1.6 ±0.84 p < 0.0001). In the MVR group, there have been 41 late deaths, and the actuarial survival was 80% ± 3% at 5 years and 63% ± 5% at 10 years. Twenty-eight patients have sustained thromboembolic complications (2.9%/ patient-year), and the probability of remaining free of thromboembolism at 10 years is 77% ± 5% The mean improvement in New York Heart Association functional class is from 3.4 ± 0.63 preoperatively to 1.8 ± 0.91 postoperatively ( p < 0.0001). There were no mechanical failures, but 19 patients underwent 22 replacements of a previously implanted St. Jude prosthesis for endocarditis (14), paravalvular leak (4), thrombosis (2), and hemolysis (2). This intermediate-term follow-up confirms our earlier impression that in adults in whom valve repair is not possible, the St. Jude valve is a reliable, durable prosthesis with excellent hemodynamic function and a low rate of thrombosis/thromboembolism.

The St. Jude valve. Thrombolysis as the first line of therapy for cardiac valve thrombosis.

Thrombolytic therapy is a promising alternative to valve replacement in the management of prosthetic valve thrombosis. We sought to determine the short- and long-term results of treating thrombosed St. Jude heart valves with thrombolytic therapy as the primary treatment modality. Between March 1978 and December 1991, 988 patients underwent implantation of St. Jude prosthetic valves at our medical center, and all patients with thrombosed valves were identified prospectively. During this period, 17 patients (13 women; mean age, 66.8 +/- 19.0 years) developed prosthetic valve thrombosis (11 aortic, six mitral). In six patients, Coumadin was stopped in preparation for elective surgery. The clinical presentation was congestive heart failure in 13, syncope and fatigue in two, and a cerebrovascular accident in one; one patient was asymptomatic. The average duration of symptoms was 11.7 +/- 12.0 days (range, 1-45 days). Anticoagulation was subtherapeutic in all but one patient at the time of presentation. Cinefluoroscopy was the primary method used for diagnosis and was also used to follow the response to therapy. Twelve patients were treated medically (10 with thrombolytic therapy and two with heparin), three were treated surgically, and two were diagnosed at autopsy. Of the 12 medically treated patients, 10 had marked improvement in leaflet movement and symptoms within 12 hours. Thus, 10 of 12 patients (83%) had a satisfactory response to medical therapy alone. No medically treated patient died or had a major complication resulting in permanent damage. However, four of the 12 medically treated patients had minor complications, including a transient episode of facial weakness in one patient, hematomas in two, and epistaxis in one. Late rethrombosis recurred in two patients in the medically treated group and was successfully retreated with thrombolytic therapy. At 3 months, all patients were alive and well. Thrombolytic therapy can be used as the first line of therapy for thrombosed St. Jude valves with a low risk of permanent side effects and excellent chances of success. In most cases, surgery can be reserved for patients who do not respond to thrombolytic therapy.