The St. Jude "Silzone" valve: midterm results in treatment of active endocarditis

BACKGROUND: The Silzone-coated St. Jude Medical valve (SJM "Silzone" valve), developed to reduce prosthetic valve endocarditis (PVE), was recalled by SJM due to a higher rate of paravalvular leaks. The aim of this study was to determine the efficacy of the SJM "Silzone" valve in avoiding PVE and to evaluate the frequency of paravalvular leaks, when the valve was used exclusively for active bacterial endocarditis. METHODS: From January 1998 to December 1999, the SJM "Silzone" valve was implanted in 40 consecutive patients with active endocarditis (20 aortic, 14 mitral, and 6 both valves). Late transesophageal echocardiography was performed in 87% of survivors, and transthoracic echocardiography in the remaining 13%. Follow-up was 100%. RESULTS: Hospital mortality was 17.5%. Early PVE occurred in 2 of 40 patients (5%). There were two late deaths without signs of recurrent PVE. A hemodynamic relevant paravalvular leak necessitating reoperation was seen in 2 patients within 6 months after operation. The rate of a minor paravalvular leak was 13% (4 of 31 patients). CONCLUSIONS: The SJM "Silzone" valve when implanted for active bacterial endocarditis does not give better results than other mechanical prostheses with regard to early recurrence of endocarditis. The rate of a hemodynamic relevant paravalvular leak requiring reoperation seems rather high during the early postoperative period, whereas the occurrence of minor paravalvular leaks is comparable with that of other mechanical prostheses. Routine observation, recommended for all patients with mechanical heart valves, is also sufficient for patients with the SJM "Silzone" valve.     

Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT

BACKGROUND: The Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare endocarditis rates in Silzone versus conventional valves. Recruitment ended January 21, 2000, because of higher rates of paravalvular leakage in patients receiving the Silzone prosthesis. The present analysis determined late event rates that might be used in the management of approximately 36,000 patients who have received the Silzone prosthesis. METHODS: A total of 807 patients in 19 centers in North America and Europe were randomized. Mean age was 61+/-11 years; 41% were women. Operations included aortic valve replacement in 59%, mitral valve replacement in 32%, and aortic and mitral valve replacements in 9%; 41% had concomitant operations (26% coronary artery bypass grafting). RESULTS: Major paravalvular leakage (followed by repair, explant, or mortality) occurred in 18 of 403 patients receiving Silzone valves and 4 of 404 patients without Silzone valves (2-year event-free rates: 91.1% versus 98.9% conventional, p < 0.003). Similarly, 2-year freedom from any explant was lower in the Silzone arm (19 versus 2 events; 90.1% versus 99.4%, p = 0.0002). Rates of mortality and stroke were similar during follow-up. CONCLUSIONS: Continued follow-up of AVERT supports the conclusion that the Silzone prosthesis has increased risk of paravalvular leakage requiring reoperation. Overall survival is similar in the two groups.     

Pathologic analysis of 19 heart valves with silver-coated sewing rings

OBJECTIVE: The St. Jude Medical Silzone (Silzone) mechanical heart valve was voluntarily recalled (January 2000) due to an unusually high incidence of paravalvular leaks. We present the first series of human morphological data on the failure of these valves. METHODS: Nineteen Silzone valves were evaluated from the 176 Silzone valves implanted in 147 patients at our institution between 1997 and 1999. Explanted prostheses were fixed in 10% formalin, photographed, and X-rayed. Histological sections were collected from the sewing cuff, accompanying tissues, and thrombus. For comparison, six age-matched SJM-standard valves were similarly analyzed. RESULTS: Nineteen Silzone valves from 16 patients (10 male, six female, 52.0 +/- 15.2 years) were examined. Significantly more mitral (15/95) prostheses were removed than aortic (4/81) despite the nearly equal number implanted (p = 0.027). Fifteen of the Silzone valves (13/16 patients) were explanted in the early postoperative period (within six months of implantation), although collection continued for eight years after our institution stopped implanting them. The common indications for surgical explantation were paravalvular leak (8/12) and clinically suspected infective endocarditis (IE) (four patients, five valves). IE was not confirmed by histology or culture in any valve. The sewing cuffs of many Silzone valves showed large regions of pannus, granulation tissue, and purulent exudate. Polymorphonuclear leukocytes were more common in the sewing cuff of Silzone valves; however, the cellular infiltrate was superficial when compared to SJM-standard valves. CONCLUSION: This is the largest morphologically analyzed series of Silzone explants. It demonstrates a consistent pattern of atypical tissue incorporation into the silver-coated sewing ring particularly in the mitral position. Clinical and morphologic features of IE (sterile) are seen in the early postimplant period. Prosthesis-related problems were almost wholly seen at the mitral site, in our group. Our current data indicate that although early failure due to dehiscence and paravalvular leak is a problem, Silzone valves that "survive" past six months will likely function as well as the SJM-standard prosthesis.     

Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT)

Objective: To examine risk factors for major paravalvular leak (PVL) events after mechanical heart valve replacement. Methods: We analyzed outcome of 807 patients randomized into the Artificial Valve Endocarditis Reduction Trial (AVERT). The mean follow-up time was 30.6 months and 21 major PVL events were reported. Three additional major PVL events associated with endocarditis were excluded from analysis. All baseline medical history variables, as well as operative parameters (including use of pledgets and suture technique) were examined using Cox regression. Results: Major PVL was reported after 11 aortic, 9 mitral, and 1 double valve replacement. 6/404 (1.5%) patients with conventional valves experienced a major PVL event versus 15/403 (3.7%) in the Silzone group. 10/172 (5.8%) patients with valve suture technique without pledgets experienced a major PVL event versus 11/635 (1.7%) patients with pledgets. Final multivariable model showed that only suture technique without pledgets (p = 0.005) was an independent significant risk factor for major PVL events. Silzone cuff showed a strong trend (p = 0.055). Conclusions: Suture technique without pledgets is an independent significant risk factor for major PVL events. In this study, use of pledgets during valve replacement had a protective effect against subsequent paravalvular leak, supporting the use of buttress reinforcement for valve suture. The use of Silzone cuff, although not statistically significant, showed a strong trend as a risk factor.     

Severe haemolysis with the St. Jude Medical prosthesis

The St. Jude Medical prosthesis has become one of the most widely used mechanical heart valves because of its excellent haemodynamic function. Although subclinical haemolysis has been described with this prosthesis, there has only been a single report of frank haemolysis in the absence of a paravalvular leak. We report the occurrence of severe haemolysis in five patients following St Jude Medical prosthesis implantation, four of whom had combined aortic and mitral valve replacements. In no patient could the haemolysis be attributed either to a paravalvular leak or an obvious valve malfunction.     

Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial

The current Food and Drug Administration (FDA) heart valve guidance document uses an objective performance criteria (OPC) methodology to evaluate the clinical performance of prosthetic heart valves. OPC are essentially historical controls, but they have turned out to be an adequate, and perhaps optimal, study design in this situation. Heart valves have a simple open-and-close mechanism, device effectiveness is easy to document, and the common complications (thromboembolism, thrombosis, bleeding, leak, and infection) are well known and easily detected. Thus, randomized clinical trials (RCTs) have not been deemed necessary for the regulatory approval of prosthetic heart valves. The OPC are derived from the average complication rates of all approved heart valves. Studies based on OPC have been shown to work well; many different valve models have gained FDA market approval based on this methodology. Although heart valve RCTs are not required by the FDA, they have been done to compare valves or treatment regimens after approval. Recently, the Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare a new Silzone sewing ring, designed to reduce infection, with the Standard sewing ring on a St. Jude Medical heart valve. This was the largest heart valve RCT ever proposed (4,400 valve patients, followed for as long as 4 years), but it was stopped prematurely because of a high leak rate associated with the Silzone valve. Examining the results showed that a much smaller, OPC-based study with 800 patient-years would have been sufficient to disclose this complication of the Silzone valve.     

Long-term follow-up of St. Jude Medical valve

St. Jude Medical bileaflet valve replacement was performed on 182 patients--aortic in 90, mitral in 70, both sites in 20 and tricuspid in two. The 30-day mortality was 4.3%, and was related to poor preoperative condition (NYHA class III or IV). The late mortality during observation up to 8 years was 9.3%, with actuarial survival 87.4% at 5 years and 86.3% at 8 years. For aortic, mitral and double valve replacement the respective 8-year figures were 88, 87.3 and 76.2%. Late death was associated with high preoperative pulmonary vascular resistance in five cases, dysrhythmia in four, myocardial infarction in two, thromboembolism, paravalvular leakage, prosthetic endocarditis or bleeding, each in one case, and was accidental in two cases. Calculated per 100 patient years the incidence of late thromboembolic events was 1.0, of bleeding complications 0.9 and of prosthetic valve endocarditis and paravalvular leak 0.26 (8, 7, 2 and 2 cases). The NYHA class in the 144 cases available for follow-up was I in 63%, II in 27% and III in 10%. The St. Jude Medical prosthesis thus was reliable, with good long-term performance.     

Twenty-year comparison of tissue and mechanical valve replacement

OBJECTIVE: We sought to compare outcomes with tissue and St Jude Medical mechanical valves over a 20-year period. METHODS: Valve-related events and overall survival were analyzed in 2533 patients 18 years of age or older undergoing initial aortic, mitral, or combined aortic and mitral (double) valve replacement with a tissue valve (Hancock, Carpentier-Edwards porcine, or Carpentier-Edwards pericardial) or a St Jude Medical mechanical valve. Total follow-up was 13,390 patient-years. There were 666 St Jude Medical aortic valve replacements, 723 tissue aortic valve replacements, 513 St Jude Medical mitral valve replacements, 402 tissue mitral valve replacements, 161 St Jude Medical double valve replacements, and 68 tissue double valve replacements. The mean age was 68 +/- 13.3 years (St Jude Medical valve, 64.5 +/- 12.9; tissue valve, 72.0 +/- 12.6). RESULTS: There were no overall differences in survival between tissue and mechanical valves. Multivariable analysis indicated that the type of valve did not affect survival. Analysis by age less than 65 years or 65 years or older and presence or absence of coronary disease revealed similar long-term survival in all subgroups. The risk of hemorrhage was lower in patients receiving tissue aortic valve replacements but was not significantly different in patients receiving mitral valve or double valve replacements. Thromboembolism rates were similar for tissue and mechanical valve recipients. However, reoperation rates were significantly higher in patients receiving both aortic and mitral tissue valves. The reoperation hazard increased progressively with time both in patients receiving aortic and in those receiving mitral tissue valves. Overall valve complications were initially higher with mechanical aortic valves but not with mechanical mitral valves. However, valve complication rates later crossed over, with higher rates in tissue valve recipients after 7 years in patients undergoing mitral valve replacement and 10 years in those undergoing aortic valve replacement. CONCLUSIONS: Tissue and mechanical valve recipients have similar survival over 20 years of follow-up. The primary tradeoff is an increased risk of hemorrhage in patients receiving mechanical aortic valve replacements and an increased risk of late reoperation in all patients receiving tissue valve replacements. The risk of tissue valve reoperation increases progressively with time.     

"Our complication rates are lower than theirs": statistical critique of heart valve comparisons

OBJECTIVES: From the widely differing complication rates published for every heart valve, is it possible to determine a true rate for each valve and to compare the rates of two different valves? We investigated this question for the two most popular bileaflet valves. METHODS: Aortic valve data were abstracted from 14 St Jude Medical (St Jude Medical Inc, Minneapolis, Minn; 33,125 patient-y) and 11 Carbomedics (Sulzer Carbomedics Inc, Austin, Tex; 19,141 patient-y) series, and mitral valve data were abstracted from 11 St Jude Medical (21,553 patient-y) and 8 Carbomedics (8368 patient-y) series. Regression analysis was used to accommodate heterogeneity among rates with the same valve model, to estimate hazard ratios and 95% confidence intervals for the valve model effect, and to incorporate other series-level risk factors. RESULTS: Most of the complication rates with both valve models exhibited significant heterogeneity. For thromboembolism and bleeding, the relative risks for valve model were not significantly different from unity. Valve thrombosis rates exhibited less heterogeneity: the Carbomedics valve had a lower rate in the aortic position (hazard ratio 0.2, 95% confidence interval 0.1-0.6) and a higher rate in the mitral position (hazard ratio 1.9, 95% confidence interval 1.0-3.8). CONCLUSIONS: Unlike simple weighted averages of valve complication rates, regression methods can incorporate heterogeneity related to center effects and allow for inclusion of other risk factors. Thromboembolism and bleeding rates were not significantly different with St Jude Medical and Carbomedics valves. Valve thrombosis appeared to differ between the two valves, but the absolute differences in rates were small. Because of the variability among rates with the same valve, statistical comparisons must be interpreted cautiously.     

Clinical comparison of St. Jude and porcine mitral valve prostheses

One hundred and six consecutive patients who had mitral valve replacement with either a St. Jude or porcine heterograft prosthesis were prospectively studied. The 2 groups are similar with respect to 67 clinical and operative factors and allow comparison of valve performance as an independent variable. Total follow-up is 3,312 patient-months (mean 36 months, range 2-57 months, 94% complete). There are no statistical differences in symptomatic improvement or mortality by life table analysis. Valve-related complications expressed as percent per patient-year are: reoperation: 1.8 St. Jude and 3.8 porcine; endocarditis: 1.2 and 1.9; regurgitant murmur: 2.3 and 1.9; hemolysis: 1.8 and 0.0; late thromboembolism: 1.8 and 1.0; hemorrhage: 2.9 and 2.9; and valve failure: 0.0 and 1.0. There were no significant differences found. Actuarial survival at 3 years was 78% in St. Jude and 81% in porcine patients. Forty-six percent of patients with St. Jude valves and 55% of patients with porcine valves were alive and free of all complications at latest follow-up. The clinical performance of St. Jude and porcine mitral valves are similar over this period of intermediate follow-up.     

In vivo hemodynamics of prosthetic St. Jude Medical and Ionescu-Shiley heart valves analyzed by computer

Using a method of our own design, we evaluated intraoperatively the function of prosthetic heart valves. The changing hemodynamics induced by a stress test were assessed by simultaneously measuring the mean transvalvular pressure gradient and the stroke volume. The effective orifice area (EOA) of the valves was determined for each stroke by computer analysis, and this value was compared with the actual orifice area. Data were collected from 19 patients undergoing aortic or mitral valve replacement or both with 17 St. Jude Medical and 12 Ionescu-Shiley valves. The mean pressure gradient increased with tachycardia and an increase in mean left atrial pressure in the mitral position, but decreased with a decrease in cardiac output and peak left ventricular pressure in the aortic position. The St. Jude Medical valve had a smaller mean pressure gradient than the Ionescu-Shiley bioprosthesis. For both valves, the EOA increased with valve size. The St. Jude Medical valve had a greater EOA than the Ionescu-Shiley bioprosthesis, regardless of the valve size (p less than 0.005). However, the performance of prosthetic leaflets was better with the Ionescu-Shiley bioprosthesis than with the St. Jude Medical mechanical valve (p less than 0.001). This method involving computer analysis of each cardiac cycle proved to be useful for evaluating prosthetic heart valve function in the presence of changing hemodynamics.     

Mitral valve replacement for four times with three kinds of prosthetic valve dysfunction

There are 2 major types of prosthetic valve replacement complications; structural valvular deterioration and nonstructural dysfunction. Nonstructural dysfunction includes valve thrombosis, paravalvular leak, prosthetic valve endocarditis and bleeding event. Primary tissue failure is the most common reason for mitral valve replacement (MVR) with tissue valves, and paravalvular leak is also a common factor of MVR in repeated MVR cases. We report a case of a woman who has undergone MVR for four times. She underwent the 1st MVR with a tissue valve 19 years ago because of mitral valve regurgitation. Nine years after the initial operation, structural valvular deterioration developed and she underwent the 2nd MVR with a mechanical prosthesis. Two years after the 2nd operation, she underwent the 3rd MVR because of repeated prosthetic valve thrombosis. Paravalvular leak was recognized 8 years after the 3rd operation and she underwent the 4th MVR. Her postoperative course was uneventful.     

Ten years experience with the St. Jude Medical valve prosthesis for mitral valve replacement

During the 10-year period between 1980 and December 1989, isolated mitral valve replacement (MVR) with the St. Jude Medical (SJM) valve prosthesis was performed on 404 patients at our hospital, and a long-term postoperative follow-up was conducted. There were 161 males and 243 females ranged in age from 1 year to 73 years. Early operative mortality was 5.2%. Follow-up period for 383 patients who discharged from the hospital was 1970.7 patient-years. Twenty of these patients died during the follow-up period, and a late mortality rate was 5.2%. During 10 years, thromboembolic event occurred in 8 patients. Four patients had anticoagulant-related bleeding, 4 had paravalvular leak, and 5 underwent re-operations. There was neither structural valve failure nor prosthetic valve endocarditis. Therefore, the actuarial survival rate and the valve-related death-free rate at 10 years were 83.2%, and 96.8%. Of the patients who survived, New York Heart Association class improved significantly (93% in classes II and III preoperatively and 71% in class I postoperatively). Linearized rates for thromboembolism, anticoagulant-related bleeding, and hemolysis were 0.41%, 0.20% and 0.36%/100 patient-years, respectively. The actuarial estimate of incidence free from all complications was 92.0% at 10 years. On the basis of this 10 years' experience, we believe that the SJM valve prosthesis is an excellent mechanical prosthesis for mitral valve replacement, in terms of hemodynamic performance and low thrombogenicity in patients receiving anticoagulants.     

Clinical experience with the Medtronic-Hall valve prosthesis

Medtronic-Hall valves were implanted during 204 procedures performed between 1982 and 1988. Mean population age was 54.4 years; 96% of patients were in New York Heart Association functional class III or greater. Emergency operations constituted 16% of the procedures. Rheumatic heart disease was the single most common indication for valve replacement. In 18% of patients, operation was performed to replace a previous prosthetic valve. The mean follow-up was 3.2 years. Overall operative mortality was 10.3%, the highest mortality being for double-valve replacements (24%). Valve-related mortality, by position, was 5.3% for aortic valves, 6.0% for mitral valves, and 4.0% for multiple-valve replacements. Actuarial 5-year freedom from events were: survival, 68%; thromboembolism, 90%; prosthetic valve endocarditis, 98%; paravalvular leak, 95%; and reoperation, 92%. Complications with the highest mortality were thromboembolism (36%) and endocarditis (33%). The complication rates in this series are high but the patients were more severely ill than in other reports, and operative survivors experienced a considerable improvement in New York Heart Association functional class.     

Experience of the small size (25 mm) Sorin Bicarbon bileaflet prosthetic valve in patients with small mitral annuli

BACKGROUND: Currently, there is a tendency to use large-size prosthetic valves in mitral position in order to achieve better hemodynamic performance. We aimed to evaluate hemodynamic performance of 25 mm prosthetic valves in mitral position. METHODS: Between August 1998 and May 2000, a total of 40 patients, 34 women and 6 men (mean age 42 +/- 12 years), underwent mitral valve replacement with 25 mm bileaflet mechanical valve. Preoperative functional capacity was New York Heart Association classes III and IV in 31 patients. Major indication for surgery was severe mitral stenosis in all patients. RESULTS: Total hospital mortality was 5% (two patients). Mean follow-up period was 14.7 +/- 4.9 months (2 to 23 months). No thromboembolic event, paravalvular leak, mechanical failure, endocarditis were observed during the follow-up period. Postoperatively 92.5% of the patients were in the functional capacity of New York Heart Association class I. Postoperative echocardiographic observations have given an average pulmonary artery pressure of 29 +/- 2 mmHg, effective orifice area as 2.95 +/- 0.1 cm2, and mean prosthetic gradient as 6.5 +/- 2.7 mmHg. CONCLUSION: In short- and mid-term, small-size (25 mm) Sorin mechanical mitral valves had excellent hemodynamic performance in patients with severe mitral stenosis, moderate or serious pulmonary hypertension, and small mitral annuli, whose body surface area was smaller than 1.6 m2.     

Immediate and long-term outlook for valve replacement in acute bacterial endocarditis.

The clinical course of 22 patients with acute endocarditis treated surgically less than six weeks after the onset of antibiotic therapy was reviewed. The aortic valve was infected in 13 patients, the mitral in six, the tricuspid in two, and one patient had both aortic and mitral valve involvement. The indications for surgical intervention before the completion of adequate antibacterial therapy included uncontrollable congestive heart failure, persistent sepsis, systemic embolization, and multiple septic pulmonary embolizations. The annulus was involved by the infectious process in five of the 13 patients with aortic valve endocarditis, in one of the two patients with tricuspid valve infection, and in none of the patients with mitral valve endocarditis. There were two surgical deaths, for a mortality of 9.1%. During the follow-up period, four patients died three months, seven months, four years, and seven years after surgery. The remaining patients have been followed up for a period of five months to 10 years. One patient has a hemodynamically insignificant paravalvular leak, and another developed paravalvular regurgitation and a false aneurysm of the left sinus of Valsalva two weeks after the initial operation. She subsequently underwent successful valve replacement and repair of the aneurysm. This study confirms that valvular replacement should be done for acute endocarditis as soon as indicated, and that the incidence of reinfection and/or the development of valvular or paravalvular problems is small even in the patients with incomplete antimicrobial therapy, whether or not the annulus is involved by the infectious process.     

Long-term performance of porcine heart valve bioprostheses

To assess the results after long-term implantation of porcine bioprosthetic heart valves, 320 patients with 381 valves were retrospectively reviewed. This group included all patients receiving one such xenograft in the mitral or aortic position (or both) in our institution between June 1974 and December 1976. The patients had a follow-up of 9-11.5 years. Actuarial patient survival rats (hospital mortality excluded) were 85%-90% at 6 years and 68%-79% at 11.5 years. Thromboembolic episodes did not show any significant clustering over the first weeks or months, in fact, they appeared at a constant rate. Actuarial rates of freedom from thromboembolism were greater than 90% for aortic patients at 11.5 years and greater than 80% for mitral and mitroaortic patients at 11.5 years. The linearized rate of anticoagulant-related haemorrhage for the whole group of patients was 0.4 events/100 patient years with a related mortality of 0.2 events/100 patient years. Prosthetic valve endocarditis and paravalvular leak appeared at linearized rates of 0.6 (0.1 of related mortality) and 0.4 (0.1 of related mortality) events/100 patient years. Primary tissue valve failure constituted the most prevalent complication (82 cases) in the long term but did not significantly worsen patient survival. Actuarial rates of freedom from primary tissue failure were 91% +/- 2% at 6, and 40% +/- 14% at 11.5 years for mitral valves, and 95% +/- 4% at 6 and 64% +/- 6% at 11.5 years for aortic valves.(ABSTRACT TRUNCATED AT 250 WORDS)     

Eleven years' experience with Carpentier-Edwards biological valves in relation to survival and complications

The Carpentier-Edwards porcine valve bioprosthesis was implanted in 299 patients (325 prostheses) from April 1976 to April 1982. The series consisted of aortic valve replacement in 150 patients, mitral valve replacement in 120, multiple valve replacement in 26, pulmonary valve replacement in 2 and tricuspid valve replacement in 1 patient. The postoperative follow-up was 100% complete. The total accumulated follow-up was 1956 patient-years. The early mortality was 6.4% (20 patients) and the late mortality was 22% (62 patients). Valve-related mortality was seen in 8 patients (2.7%): 1 paravalvular leak during the 1st 30 postoperative days and 7 late mortalities (1 endocarditis, 2 paravalvular leaks and 4 deaths during reoperation). Three operative deaths (1.5%) occurred. The overall patient survival including operative deaths was 78.5% +/- 5% at 5 years and 66% +/- 4% at 10 years. The incidence of the different complications were: thromboembolism in 5 patients (1.7%) with a risk of 0.3%, haemorrhage in 1 (0.3%) with a risk of 0.05%, endocarditis in 2 (0.7%) with a risk of 0.1%, and paravalvular leak in 11 patients (3.7%) with a risk of 0.6%. There was a high incidence of tissue failure during the last 6 years which occurred in 54 patients (18%) with a risk of 2.7%. Sixty-seven patients (22.5%) were reoperated upon during the 11 years with an annual risk of 3.4% and the main cause of reoperation was primary tissue failure. The Carpentier-Edwards biological valve was shown to be efficient during the first 5 years of implantation after which the incidence of tissue failure increased.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical use of glutaraldehyde preserved stent-mounted semilunar homograft valves

The results of mitral valve replacement with flexible stent-mounted antibiotic sterilised, glutaraldehyde preserved semilunar homografts are reported in 104 patients with isolated mitral valve disease. Thirty per cent patients belonged to NYHA class IV and 68 per cent were in class III. The hospital mortality was 26.9 per cent. Of the total 67 hospital survivors 72.37 per cent patients were available for follow-up. Time-related late death rate is 6.06±2.02 per cent per year. Valve-related complications involved allograft stenosis in two patients, allograft regurgitation in one, paravalvular leak in one, thromboembolic episode in one and infective endocarditis in two patients. Good functional results were achieved in the surviving patients. The valves were provided free of cost to the patients.     

Biological versus mechanical valves. Analysis of 1,116 valves inserted in 1,012 adult patients with a 4,818 patient-year and a 5,327 valve-year follow-up

All surviving patients between 18 and 88 years of age receiving biological or mechanical prosthetic heart valves at the Yale-New Haven Hospital from January 1974 through January 1985 were analyzed for thromboembolism, anticoagulation-related hemorrhage, endocarditis, perivalvular leak, valve failure, need for reoperation, late cardiac death, and valve-related death. The rates of these events were analyzed in linear and actuarial terms over the 11 year period. A total of 533 patients received 606 biological valves (328 aortic, 252 mitral, 24 tricuspid, and two pulmonary, consisting of 482 Carpentier-Edwards, 108 Hancock, 15 Ionescu-Shiley, and one other), with a mean follow-up of 2,571 patient-years and 2,935 valve-years. They were compared with 479 patients with 510 mechanical valves (330 aortic, 175 mitral, and five tricuspid, consisting of 178 Starr-Edwards, 166 St. Jude Medical, 164 Bj?rk-Shiley, and two others), which were implanted for 2,247 patient-years and 2,392 valve-years. We found a significantly increased incidence of thromboembolism (p less than 0.001) and reoperation for perivalvular leak (p less than 0.05) in the mechanical valves compared with the biological valves, but a significantly increased rate of valve failure (p less than 0.001) in the biological valves compared with the mechanical valves. The overall analysis comparing total morbidity and valve-related mortality significantly (p less than 0.01) favored the biological valves in the first 5 years of the study and the mechanical valves (p less than 0.001) in the second 5 years of the study. However, the net 10 year results showed no significant difference between the two types of valves. In summary, we found little direct evidence to strongly support the generalized use of one type of valve over another.