The Medtronic-Hall cardiac valve: 7 1/2 years' clinical experience

Clinical information on the Medtronic-Hall valve prosthesis was obtained by reviewing the records of 379 patients, 164 of whom had aortic valve replacement (AVR), 163 of whom had mitral valve replacement (MVR), and 52 of whom had double valve replacement over 90 months (1,225 patient-years) (mean follow-up, 42.01 +/- 1.3 months [+/- standard error]). Mean age was 53.8 +/- 12 years. One hundred ninety-three patients (50.9%) had some type of concomitant operation, such as tricuspid annuloplasty, coronary artery bypass grafting, or resection of ascending aortic aneurysm. Ninety-one percent were in New York Heart Association (NYHA) Functional Class III or IV preoperatively. Early mortality and late mortality were 7.7% (29 patients) and 13.5% (51 patients), respectively. The actuarial survival at 7 1/2 years was 74.1 +/- 2.7% for the total group and 69.0 +/- 4.5% for those having AVR, 81.0 +/- 3.2% for those having MVR, and 67.0 +/- 8.9% for those having double valve replacement. All patients but 2 were maintained on a regimen of chronic anticoagulation with warfarin sodium. Twenty-six thromboembolic episodes occurred (2.1/100 patient-years): 13 after MVR (2.3/100 patient-years), 11 after AVR (2.1/100 patient-years), and 2 after double valve replacement (1.4/100 patient-years). Four thromboembolic episodes were fatal; no valve thrombosis occurred. There were no structural failures. Of the 350 late survivors, 92% were in NYHA Functional Classes I and II. Total valve-related complications have been minimal.(ABSTRACT TRUNCATED AT 250 WORDS)     

Experience with the Carpentier-Edwards Porcine Valve Prosthesis in 700 Patients

The Carpentier-Edwards porcine valve prosthesis has afforded our patients a satisfactory quality of life and a low incidence of valve-related complications at follow-up periods of up to five years. From December, 1975 to March, 1980, 768 prostheses were implanted in 700 patients (aortic valve replacement [AVR], 334; mitral valve replacement [MVR], 292; tricuspid valve replacement [TVR], 6; and multiple valve replacement, 68). One hundred and thirty-seven patients (19.6%) had had previous cardiac operations. Concomitant aortocoronary bypass was performed in 127 patients (18.1%). There were 52 hospital deaths, for a mortality of 7.4% (AVR, 4.8%; MVR, 9.2%; multiple valve replacement, 11.8%). Total follow-up was 1,047 patient-years (range, 6 to 60 months, mean, 19.4 months). There were 33 late deaths (AVR, 1.7% per patient-year; MVR, 4.0% per patient-year; multiple valve replacement, 8.1% per patient-year). Eight percent of AVR patients and 47% of MVR and multiple valve replacement patients were taking anticoagulants. The valve-related complications (expressed as events per 100 patient-years) were as follows: (1) thromboembolism (AVR, 0.94; MVR, 1.42; multiple valve replacement, 4.62); (2) infective endocarditis (AVR, 0.94; MVR, 0.24; multiple valve replacement, 2.31); (3) periprosthetic leak (AVR, 0.94; MVR, 0.71; multiple valve replacement, 3.46); and (4) valve dysfunction (MVR, 0.24). The only case of valve dysfunction was a calcified mitral prosthesis in a 13-year-old girl. Actuarial survival, including operative deaths, was as follows: AVR, 90.5% at 36 months; MVR, 84% at 36 months; and multiple valve replacement, 74% at 24 months. Of surviving patients, 93.6% were in New York Heart Association Class I or II at follow-up evaluation.     

Hematological complications with the St. Jude valve and reduced-dose Coumadin

We examined hematological complications in 415 patients having valve replacement with the St. Jude mechanical prosthesis (212, aortic valve replacement [AVR]; 159, mitral valve replacement [MVR]; and 44, AVR + MVR). There were 164 men and 251 women with a mean age of 59 years (range, 20 to 88 years). Preoperatively 386 patients were in New York Heart Association functional classes III and IV. There were 154 associated procedures (37%), the most common being myocardial revascularization. Overall hospital mortality was 7.5% (31/415), 7% after AVR, 8% after MVR, and 7% after AVR + MVR. All operative survivors were anticoagulated with Coumadin (crystalline warfarin sodium) to maintain the prothrombin time at 1.5 times control. During a mean follow-up of 21 months (range, 6 to 60 months), there were 29 late deaths (7.6%) and 5 patients (1.3%) lost to follow-up. No patient experienced structural valve degeneration. At 48 months, actuarial freedom from thromboembolism was 87% +/- 3% after AVR and 91% +/- 9% after MVR; from anticoagulation-related hemorrhage, 97% +/- 3% after AVR and 91% +/- 3% after MVR; and from hemolysis, 100% after AVR and 98% +/- 2% after MVR. Freedom from all valve-related morbidity at 4 years was 82% +/- 5% after AVR and 75% +/- 10% after MVR. Actuarial survival at 48 months was 80% +/- 4% after AVR and 65% +/- 7% after MVR.     

Durability and low thrombogenicity of the St. Jude Medical valve at 5-year follow-up

Between November, 1978, and December, 1983, 736 patients had valve replacement with the St. Jude Medical valve prosthesis. There were 478 patients with aortic valve replacement (AVR), 188 with mitral valve replacement (MVR), 63 with double valve replacement, and 7 with tricuspid valve replacement (they were not included in this study). The mean age at the time of operation was 46.7 years for patients having AVR and 48.6 years for those having MVR and AVR + MVR. Follow-up totaled 1,116 patient-years (range, 4 to 82 months). Early (30-day) mortality was lowest for isolated MVR (2.3%) and AVR (3.7%), and increased with reoperation or when associated procedures were combined with valve replacement. Patients undergoing reoperation or having associated procedures made up 49% of the AVR and 54% of the MVR groups. All patients were advised of the need for long-term anticoagulation with warfarin sodium. Nine patients (7 with AVR, 1 with MVR, 1 with AVR + MVR) had suspected or confirmed episodes of systemic thromboembolism, a linearized incidence of 0.99% per patient-year for AVR, 0.36% per patient-year for MVR, and 0.98% per patient-year for AVR + MVR. Eight patients with AVR underwent reoperation for prosthetic valve endocarditis (5 of the 8 patients had endocarditis prior to initial valve replacement). There were no instances of structural valve failure. There were 37 late deaths. Actuarial survival at 5 years (excluding early mortality, 95% confidence limits) was 89.8% for AVR, 84.8% for MVR, and 95.2% for AVR + MVR.(ABSTRACT TRUNCATED AT 250 WORDS)     

Early Results of Valve Replacement with the Björk-Shiley Convexoconcave Prosthesis

The Björk-Shiley convexoconcave prosthetic valve has design characteristics that may result in a lower incidence of thromboembolic complications than the conventional spherical Björk-Shiley prosthesis. We evaluated the results of valve replacement with the convexoconcave prosthesis in 248 patients receiving 301 prosthetic valves between March, 1979, and June, 1981. One hundred thirteen patients had aortic valve replacement (AVR), 73 had mitral valve replacement (MVR), and 62 had multiple valve replacement. Two hundred nine (84%) were in New York Heart Association Class III or IV. The median duration of follow-up was 13 months, and follow-up information was available for 246 (99%) of the patients. The actuarial incidence of freedom from thromboembolism at two years was 98% in the AVR group, 97% in the MVR group, and 87% in the group having multiple valve replacement. There were no documented episodes of valve thrombosis or mechanical failure and no fatal thromboembolic complications. The absence of valve thrombosis is in marked contrast to the results reported with the spherical disc valve. Although longer follow-up is necessary, it appears that the convexoconcave design represents a major improvement in the Björk-Shiley prosthesis.     

Long-term experience with the St. Jude Medical valve prosthesis.

BACKGROUND: All patients undergoing St. Jude Medical valve replacement at the Medical University of South Carolina since January 1979 have been followed prospectively at 12-month intervals. METHODS: This report describes long-term experience in 710 adult patients undergoing isolated aortic (AVR) (418) or mitral valve replacements (MVR) (292) with this prosthesis from January 1979 to December 1996. RESULTS: Ages ranged from 19 to 84 years (54.8 +/- 15.1 AVR, 51.8 +/- 12.9 MVR; mean +/- SD). Male gender predominated in the AVR group (70%) and female gender in the MVR group (62%). One hundred and fifty-seven patients (22%) had associated coronary artery bypass grafting (AVR 27%, MVR 15%). Thirty-day operative mortality was 5.3% (22/418) in the AVR group and 5.1% (15/292) in the MVR group. Follow-up is 96.9% complete and ranges from 1 month to 16.9 years (AVR, 2,376 patient-years, mean 5.7 +/- 4.5 years; MVR, 1,868 patient-years, mean 6.4 +/- 4.8 years). In the AVR group, 120 late deaths have occurred and actuarial survival was 78.0 +/- 2.3%, 58.0 +/- 3.2%, and 36.8 +/- 4.8%; at 5, 10, and 15 years, respectively. Forty-six patients have sustained 55 thromboembolic (TE) events (2.3%/patient-year). Fifty-one patients had anticoagulant-related bleeding complications (2.7%/patient-year). The mean improvement in New York Heart Association (NYHA) functional class from preoperative to postoperative was 3.0 +/- 0.8 to 1.7 +/- 0.1 (p < 0.05). In the MVR group, there have been 84 late deaths, and the actuarial survival was 79.3 +/- 2.5%, 60.1 +/- 3.5%, and 49.3 +/- 4.1% at 5, 10, and 15 years, respectively. Fifty-two patients have had 64 TE events (3.5%/patient-year). Twenty-three patients had anticoagulant-related bleeding complications (1.6%/patient-year). The mean improvement in NYHA functional class was from 3.3 +/- 0.6 to 1.8 +/- 0.1. There were no mechanical failures in either group. CONCLUSIONS: With a follow-up now extending to 17 years, the St. Jude Medical valve continues to be a reliable mechanical prosthesis with low and stable rates of valve-related complications.     

The initial experience with the ATS Medical mechanical cardiac valve prosthesis

BACKGROUND: From May 1994 through October 2000, a total of 1,146 patients underwent valve replacement with the ATS Medical mechanical cardiac valve prosthesis under a study protocol approved by international ethics committees (non-United States participants) or under a United States Food and Drug Administration-approved Investigational Device Exemption study. The study took place at 19 domestic and three international centers. METHODS: As required by the Food and Drug Administration's Heart Valve Guidance Document, only isolated implants were included in the study (double-valve implants were excluded), with operative and follow-up data collected from each center. RESULTS: Aortic valve replacement (AVR) was conducted in 801 patients (309 with coronary bypass) and mitral valve replacement (MVR) in 345 patients (78 with coronary bypass). Overall operative (< or = 30 days post implant) mortality was 2.1% (17 AVR = 2.1%, 7 MVR = 2.0%), 7 of which (AVR = 4, MVR = 3) were valve related. In 2,086 patient-years (1,459 AVR patient-years, 627 MVR patient-years) of follow-up, there were an additional 50 patient deaths of these, 18 were valve related, 9 due to anticoagulant related bleeding, 5 sudden/unexplained, and 1 each after stroke, thrombosis, prosthetic valve endocarditis, and thromboembolism. Late (>30 days post implant) valve-related complications included: transient and chronic thromboembolism (27 AVR (linearized rate 1.85%/patient-year) and 20 MVR (3.19%/patient-year), of which 11/47 (0.53%/patient-year) had chronic deficits, thrombosis (1 AVR = 0.07%/patient-year and 4 MVR = 0.64%/patient-year), paravalvular leak (10 AVR = 0.69%/patient-year and 8 MVR = 1.28%/patient-year), anticoagulant related hemorrhage (34 AVR = 2.33%/patient-year and 8 MVR = 1.28%/patient-year), prosthetic valve endocarditis (3 AVR = 0.21%/patient-year and 2 MVR = 0.32%/patient-year), and structural valve failure or dysfunction (0%). Echocardiographic gradients were proportional to valve size and did not significantly change over the follow-up period. CONCLUSIONS: This study documented the ATS Medical mechanical cardiac valve prosthesis to be a valuable addition to the surgeon's armamentarium in the treatment of cardiac valvular disease.     

Long-term outcomes of valve replacement with modern prostheses in young adults.

OBJECTIVES: To examine the multiple impacts of valve replacement on the lives of young adults. METHODS: Patients (N=500) between age 18 and 50 who had aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed annually. Events, functional status, and quality of life were examined with regression models. RESULTS: Median follow-up was 7.1+/-5.3 years (maximum 26.7 years). Five, 10, and 15-year survival was 92.7+/-1.7, 88.3+/-2.4 and 80.1+/-4.7% after AVR, and 93.1+/-2.3, 79.5+/-4.3 and 71.5+/-5.4% after MVR, respectively. Survival decreased with concomitant coronary disease (hazard ratio (HR): 4.5) and preoperative LV grade (HR: 2.0/grade increase) in AVR patients, and with atrial fibrillation (HR: 5.5), coronary disease (HR: 5.7), preoperative left atrial diameter (HR: 3.0/cm increase) and NYHA class (HR: 2.1/class increase) in MVR patients. Despite reoperation, late survival was equivalent between bioprostheses and mechanical valves in both implant positions. The ten-year cumulative incidence of embolic stroke was 6.3+/-2.4% for mechanical AVR patients, 6.4+/-2.9% for bioprosthetic AVR patients, 12.7+/-3.9% for mechanical MVR patients, and 3.1+/-3.1% for bioprosthetic MVR patients. Atrial fibrillation (HR: 2.8) and smoking (HR: 4.0) were risk factors for stroke in MVR patients. In AVR patients, SF-12 physical scores, freedom from recurrent heart failure, and freedom from disability were significantly higher in bioprosthetic than mechanical valve patients. Career or income limitations were more often subjectively linked to a mechanical prosthesis in both implant positions. CONCLUSIONS: Late outcomes of modern prosthetic valves in young adults remain suboptimal. Bioprostheses deserve consideration in the aortic position, as mechanical valves are associated with lower physical capacity, a higher prevalence of disability, and poorer disease perception. Early surgical referral and atrial fibrillation surgery may improve survival after MVR.     

Mid-term surgical results after valve replacement with the carbomedics valve prosthesis

We present herein a review of 95 patients who underwent valve replacement with the CarboMedics (CM) valve prosthesis between April 1990 and December 1992. The operative mortality for the entire group was 4.2%: 0% following aortic valve replacement (AVR), 2.7% following mitral valve replacement (MVR), and 12.5% following double valve replacement (DVR). All patients were prescribed warfarin and bucolome for anticoagulation, and were followed up for a mean period of 29.9 months. Late mortality was 8.4%: 3.1% following AVR, 10.8% following MVR, and 12.5% following DVR. There were no cases of mechanical prosthetic valve failure, significant hemolysis, infective prosthetic valve endocarditis, or bleeding complications. After 44 months of follow-up, the actuarial freedom from complications was calculated as: thromboembolism, 97.8±1.6%; valve thrombosis, 97.8±1.1%; paravalvular leak, 96.7±1.9%; and reoperation, 98.9±1.1%. The overall survival rate was 84.3±6.3% and all survivors showed a significant improvement in NYHA functional class, from 81% in classes III and IV preoperatively to 99% in classes I and II postoperatively. The CM valve exhibited no significant differences in hemolytic parameters or hemodynamic performance after isolated AVR or MVR compared with the similar type of St. Jude Medical bileaflet valve. The evidence provided by the present study therefore suggests that the CM valve prosthesis can achieve excellent mid-term clinical results and hemodynamic performance with a low incidence of thromboembolism and valve thrombosis.     

Aortic valve replacement in patients 75 years old and older

A consecutive group of 100 patients in the eighth decade of life who had aortic valve replacement (AVR) from 1975 through 1986 were retrospectively studied. Eighty-five of them were in New York Heart Association (NYHA) Functional Class III or IV. Isolated AVR was performed in 44 patients and AVR with concomitant procedures, in 56. Perioperative mortality (30 days) was 3%, and perioperative morbidity included 83 complications in 60 patients. Long-term follow-up was available on 93 patients, 71 of whom were alive and 22 of whom were dead. Sixty-eight of the 71 long-term survivors are now in NYHA Class I or II. The low rate of perioperative mortality and the improved quality of life after AVR support the performance of this procedure in this older population.     

Midterm evaluation of the Sorin Bicarbon heart valve prosthesis: single-center experience

BACKGROUND: The purpose of this study was to perform midterm evaluation of the clinical performance of the Sorin Bicarbon mechanical heart valve prosthesis. METHODS: From November 1992 to December 2002, 328 patients underwent isolated aortic (AVR; 156) or mitral (MVR; 172) valve replacement with the Sorin Bicarbon mechanical valve. Concomitant surgery was performed in 83 patients (25.2%). RESULTS: Total hospital mortality was 5.2%. Survival at 7 years was 79.5% for AVR and 82.4% for MVR. Kaplan-Meier freedoms from valve-related complications were as follows: thromboembolism 92.7% (AVR 94.8%, MVR 92.1%); bleeding 93% (AVR 91.9%, MVR 94.5%); nonstructural dysfunction 96.6% (AVR 94.7%; MVR 97.9%); endocarditis 97.7% (AVR 97.4%, MVR 98.1%); and reoperation 95.7% (AVR 96.6%, MVR 93.9%). Overall freedom from valve-related death was 93.2% (AVR 99.3%, MVR 91.2%). At the end of follow-up, 88.9% of survivors were in New York Heart Association class I or II. CONCLUSIONS: The Sorin Bicarbon valve is a satisfactory mechanical valve prosthesis with low mortality and morbidity and good functional results.     

The CarboMedics®"Top Hat" Supraannular Prosthesis in the Small Aortic Root

Twenty-three patients, 11 men and 12 women, with a mean age of 64 (range, 34 to 78) underwent aortic valve replacement (AVR) with a CarboMedics®“Top Hat” supraannular prosthesis between March 1993 and August 1994. The top hat supraannular prosthesis, a standard bileaflet valve with the cuff transferred to the valve inflow level, allowed implantation of 21-mm, 23-mm, and 25-mm valves, where a standard 19-mm or 21-mm valve would have usually been placed. One patient who had been in preoperative cardiogenic shock died in the perioperative period. Another had an intraoperative cerebral embolism with permanent impairment. Follow-up on 22 of 23 patients over a mean period of 9 months revealed mean Doppler gradients of 18 ± 6 mmHg, 15 ± 2.8 mmHg, and 11 mmHg, for the 21-mm, 23-mm, and 25-mm valves, respectively. Functional improvement was noted, with 17 patients in New York Heart Association (NYHA) Class I and 6 in NYHA Class II, postoperatively, compared with 0 in Class I, 9 in Class II, 10 in Class III, and 4 in Class IV, preoperatively. One patient showed reduced postoperative ventricular function with fractional shortening below 25%. Pandiastolic regurgitation intrinsic to the valve graded as slight was noted in all patients. Other postoperative complications included one patient with anticoagulant-related gastrointestinal bleeding and one other with prosthetic valve endocarditis successfully treated with antibiotics. The CarboMedics® top hat valve allows a gain in prosthesis size of 2 mm to 4 mm in the aortic position over standard prostheses, resulting in favorable postoperative hemodynamics.     

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

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

Ionescu-Shiley pericardial xenografts: follow-up of up to 6 years

The results of valve replacement with the Ionescu-Shiley pericardial xenograft compare favorably with results obtained with other bioprostheses. From March, 1977, to July, 1983, 497 Ionescu-Shiley pericardial valves were implanted in 463 patients at the University of Ottawa Heart Institute. There were 292 patients who had aortic valve replacement (AVR), 140 with mitral valve replacement (MVR), 28 with double valve replacement, and 3 with triple valve replacement. The survivors were followed regularly. Actuarial analysis of late results indicates an expected survival of 71% at 6 years for patients who underwent AVR and 72% at 3 years for patients who had MVR. The only valve-related deaths were due to endocarditis, which occurred at a rate of 3.9% per patient-year for aortic valves and 0.6% per patient-year for mitral valves. Despite a low usage of formal anticoagulation, embolic complications occurred at a rate of 1.4% per patient-year for aortic valves and 4.0% per patient-year for mitral valves. Five valves were removed for intrinsic failure after 36 to 72 months of follow-up. New York Heart Association Functional Class improved an average of 1.28 classes per patient.     

"Mosaic" medtronic bioprosthetic valve replacement clinical results and hemodynamical performance

BACKGROUND: We report the mid-term results of a prospective trial of a new bioprosthetic valve. The Mosaic bioprosthesis consists of porcine aortic valve that has been cross linked ed in glutaraldehyde solution under zero-pressure fixation and treated with alpha amino oleic acid to reduce the potential for calcification. METHODS: Mosaic bioprosthetic valve replacement was performed in 67 consecutive patients between January 1995 and August 1998. There were 37 patients having aortic valve replacement (AVR) and 30 having mitral valve replacement (MVR) who entered this study. The patients age ranged 56 to 86 years (mean 74.9); 38 were female and 29 were male; 44 were in NYHA grade 3 and 21 were NYHA grade 4. All mitral valve replacements were performed with total preservation of subvalvular apparatus. Echocardiographic assessment of valve and LV function were performed on 7th day, 6 months 1,2 and 3 years. RESULTS: There was no hospital mortality. 3 year survival was 85.9+/-5.9% for AVR and 100% for MVR. Freedom from antithromboembolic related haemorrhage has been 96.7% for MVR and 91.9% for AVR. Freedom from the transient neurological event was 96.7+/-3.3% for MVR and 100% for AVR Freedom from structural valve failure, permanent thromboembolism, thrombosis or endocarditis has been 100% for both AVR and MVR. In AVR group left ventricle mass, left ventricle mass index significantly decreased, when cardiac index and effective orifice area increased significantly during study period. Transvalvular gradient did not change. In MVR group transvalvular gradient, effective orifice area and cardiac index did not change. CONCLUSIONS: The valve was user friendly. The early results are very satisfactory. Echocardiography measurements after aortic valve replacement are showing very marked late postoperative remodelling of left ventricle. After mitral valve replacement there were exceptionally low transvalvular gradients, no left ventricle outflow tract obstruction.     

Mitral valve replacement: a nine-year follow-up of risks and survivals.

Experience with mitral valve replacement over a nine-year period is reviewed. Hospital mortality was 8.9%, with an additional late mortality of 18.5% during a mean follow-up period of 4.34 years. Study of the factors influencing the results of valve replacement revealed a direct correlation between long-term survival and New York Heart Association (NYHA) Functional Class, as judged preoperatively, as well as left ventricular end-diastolic pressure, cardiac index, type of valve lesion, and presence of associated coronary artery disease. Hospital mortality was 32% (p less than 0.01) for those patients in NYHA Functional Class IV before operation, compared with 3% for Class III patients. Untreated concomitant coronary artery disease was associated with a significantly higher perioperative mortality of 28% (p = 0.002) compared with an 8% mortality in patients with coronary artery disease treated by vein bypass at the time of mitral valve replacement. Patients with normal coronary arteries documented angiographically before operation had a 1% hospital mortality. Seventy-two percent of all patients are still alive at a maximum follow-up of nine years. Eighty-three percent of those survivors who were in Functional Class III or IV before operation are now considered to be in Class I or II. We conclude that patients should undergo mitral valve replacement before the development of the advanced functional stage of valve disease. In addition, coronary arteriograms should be performed on all patients who are more than 40 years old at the time of cardiac catheterization, and revascularization considered at the time of mitral valve replacement for those patients with significant coronary disease.     

Risks of mitral valve replacement and mitral valve replacement with coronary artery bypass

One hundred thirty consecutive patients who underwent mitral valve replacement (MVR) or MVR with coronary artery bypass grafting (CABG) using cold crystalloid cardioplegic solution were analyzed to determine operative mortality and risk factors. Twenty-eight patients had mitral stenosis (MS), 37 had mitral regurgitation (MR), 37 had mixed MS and MR, 23 had MR with coronary artery disease (CAD), and 5 had MS with CAD. Preoperative pulmonary artery pressure, pulmonary capillary wedge pressure, and cardiac index were not different among groups, but patients with MR and CAD had a significantly higher left ventricular end-diastolic pressure (LVEDP) and a significantly lower ejection fraction than other groups. Mortality was 7.1% for patients with MS, 5.4% for MR, 8.1% for mixed MS and MR, 0 for MS with CAD, and 21.7% for MR and CAD. Overall mortality was 9.2%. Eleven patients had emergency operations for cardiogenic shock with a mortality of 45%. Nineteen additional patients in New York Heart Association (NYHA) Functional Class IV had MVR or MVR plus CABG with a mortality of 26%. Sixteen patients required intraaortic balloon pump assistance, and 9 survived. Four patients with MR and CAD required the left ventricular assist device, and 3 survived. Excluding patients who had emergency operations, overall mortality was 5.8%. Excluding patients who had emergency operations and patients in NYHA Functional Class IV, overall mortality was 2%. Factors associated with death were cardiogenic shock, NYHA Class IV, LVEDP greater than 15 mm Hg (16% mortality), and age greater than 60 years (15% mortality).     

Heart valve replacement with the Bj?rk-Shiley Monostrut valve: early results of a multicenter clinical investigation

To evaluate the clinical performance of the Bj?rk-Shiley Monostrut prosthesis, five centers combined their early experience. Between May, 1982, and June, 1985, 537 prostheses were implanted in 486 patients at these centers: 246 patients had aortic valve replacement (AVR), 163 underwent mitral valve replacement (MVR), and 47 had double-valve replacement (DVR). Thirty patients underwent other, more complex procedures. Concomitant cardiac procedures were performed in altogether 25%. Overall hospital (30 days) mortality was 5.1% (3.6% for AVR, 4.3% for MVR, 8.3% for DVR, and 16.6% for other procedures). The patients were followed up at 6- to 9-month intervals from 6 to 48 months (mean follow-up, 33 months). Follow-up was 99.6% complete. Late mortality was 7.2%. The three-year survival rate was 91.0% for AVR, 92.3% for MVR, and 76.2% for DVR. There was no structural failure of the prosthesis. No instances of valve thrombosis and fatal thromboembolism occurred in anticoagulated patients. The three-year incidence of freedom from thromboembolic events (including TIA) was 89.8% for AVR, 94.9% for MVR, and 90.2% for DVR. Preoperative and postoperative data for the assessment of mechanical hemolysis was available in 60% of the patients. The degree of mechanical hemolysis was low and did not change with time. Although the follow-up is still short, the Bj?rk-Shiley Monostrut prosthesis appears to represent an improvement over previous Bj?rk-Shiley models, particularly with regard to durability.     

Clinical performance of the Duromedics bileaflet pyrolite mechanical prosthesis.

The Duromedics (Baxter Healthcare Corp., Edwards CVS Div., Irvine, Calif.) mechanical cardiac valvular prosthesis was implanted in 480 patients between 1984 and 1987 at the Montreal Heart Institute, the Hospital Clinic of Barcelona and the teaching hospitals of the University of British Columbia. The mean age of the patients was 52 years. The early mortality was 7.9% and the late mortality was 4.1% per patient-year. The overall survival at 4 years for aortic valve replacement (AVR) was 87.0% +/- 3.7% and for mitral valve replacement (MVR) was 81.9% +/- 2.9%. There were 16 valve-related reoperations in 14 patients--for prosthetic valve endocarditis in 9 patients, for thromboembolism in 1 patient and for nonstructural dysfunction in 4 patients. The freedom from thromboembolism at 3 and 4 years was 94.3% +/- 3.1% for AVR and 95.1% +/- 1.8% for MVR. The freedom from prosthetic valve endocarditis at 3 and 4 years was 95.3% +/- 2.2% for AVR and 96.2% +/- 1.6% for MVR. The freedom from structural valve deterioration for all positions was 100%. The freedom from reoperation at 4 years was 95.3% +/- 2.1% for AVR and 92.3% +/- 4.3% for MVR and from valve-related death was 98.7% +/- 1.3% for AVR and 96.2% +/- 1.6% for MVR. The freedom from all valve-related complications at 4 years was 87.7% +/- 3.8% for AVR and 85.7% +/- 2.9% for MVR. Long-term evaluation of the Duromedics prosthesis is required to determine the influence of documented structural valve deterioration.     

2349例心脏瓣膜置换术早期死亡原因分析

目的 分析2349例心脏瓣膜置换术病人的死亡原因,以期进一步提高治疗水平.方法 1995年1月至2007年12月,2349例心脏瓣膜病病人接受人工心脏瓣膜置换手术.其中二尖瓣置换术(MVR)1333例,主动脉瓣置换术(AVR)271例,二尖瓣、主动脉瓣同期置换术(DVR)736例,三尖瓣置换术(TVR)9例.结果 早期病死率1995年至1999年6.81%,2000年至2004年3.22%,2005年至2007年2.82%.全组总早期病死率3.40%.结论 心脏瓣膜置换术早期死亡的原因主要是低心排血量综合征、肾功能衰竭、心律失常、肺部感染、脑血管意外、左室破裂和多器官系统功能衰竭等.