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1.  Twenty-Two-Year Experience with Aortic Valve Replacement 
Texas Heart Institute Journal  1991;18(1):24-33.
From 1965 through 1986, 817 patients underwent aortic valve replacement at our institution. Six hundred forty-five patients received Starr-Edwards ball valves, including 286 Silastic ball valves (Models 1200/1260), 165 cloth-covered caged-ball prostheses (Models 2300/2310/2320), and 194 track-valve prostheses (Model 2400). In contrast, 172 patients received disc-valve prostheses, including 126 St. Jude Medical aortic bi-leaflet disc valves, 32 Lillehei-Kaster pivoting disc valves, and 14 Björk-Shiley valves (6 convexoconcave and 8 monostrut).
With respect to preoperative data, the 2 groups were comparable, with the following differences. The Starr-Edwards group included 1) more men (77% versus 51%; p < 0.0001); 2) a significantly older patient population (59 ± 10 years versus 56 ± 15 years; p < 0.0001); 3) more patients in New York Heart Association functional class III or IV (72% versus 65%; p < 0.01); 4) fewer patients with angina pectoris as a limiting symptom (20% versus 36%; p < 0.0001); and 5) patients who tended to receive larger prostheses (26 ± 2 mm versus 23 ± 3 mm, p < 0.0001).
The overall 10-year survival rate ± standard error was 59% ± 2% for patients receiving Starr-Edwards valves and 63% ± 6% for those with disc valves. The linearized complication rates (expressed as percentage per patient-year ± standard error) for the Starr-Edwards and disc-valve groups, respectively, were 2.0% ± 0.2% and 1.4% ± 0.5% for thromboembolism, 2.1% ± 0.2% and 3.9% ± 0.8% for Coumadin-related hemorrhage, 0.5% ± 0.1% and 0.3% ± 0.2% for endocarditis, 0.3% ± 0.1% and 0.7% ± 0.3% for other prosthesis-related complications, and 4.8% ± 0.1% and 6.4% ± 1.0% for all complications together. There were no instances of thrombotic occlusion or mechanical failure. After the 6th postoperative year, no thromboembolic events were encountered in patients with a Silastic ball valve; the 15-year freedom from thromboembolic events was 89%. Cox regression analysis showed that 1) a prosthetic orifice diameter of 15 mm or less was associated with an increased mortality; 2) disc valves entailed an increased rate of hemorrhage and prosthesis-related complications considered as a whole; 3) and Lillehei-Kaster valves led to an increased rate of prosthesis-related complications other than thromboembolism, hemorrhage, and endocarditis. Neither the type of prosthesis nor the size influenced the rate of thromboembolism, endocarditis, or prosthesis replacement. Because of their proven durability and relatively low price, we advocate the continued use of Starr-Edwards Model 1260 Silastic ball valves that have an orifice diameter of 16 mm or more. (Texas Heart Institute Journal 1991;18:24-33)
PMCID: PMC324957  PMID: 15227505
Aortic valve replacement; heart valve prosthesis; St. Jude Medical valve; Starr-Edwards ball valves; valvular heart disease
2.  Haemolysis with Björk-Shiley and Starr-Edwards prosthetic heart valves: a comparative study 
Thorax  1974;29(6):624-632.
Slater, S. D., Sallam, I. A., Bain, W. H., Turner, M. A., and Lawrie, T. D. V. (1974).Thorax, 29, 624-632. Haemolysis with Björk-Shiley and Starr-Edwards prosthetic heart valves: a comparative study. A comparison was made of the haemolytic complications in 85 patients with two different types of Starr-Edwards cloth-covered ball and cage prosthesis with those in 44 patients with the Björk-Shiley tilting disc valve. Intravascular haemolysis, as detected by the presence of haemosiderinuria, occurred significantly less often with the Björk-Shiley than with the Starr-Edwards valve, the overall incidence with aortic, mitral or multiple replacements being 31%, 15%, and 20% for Björk-Shiley and 94%, 92%, and 88% for Starr-Edwards valves respectively. There was no significant difference in the frequency of haemolysis between each of the two types of Starr-Edwards prosthesis studied at either the aortic (2300 versus 2310 model) or mitral (6300 versus 6310) site.
Haemolytic anaemia developed in only one patient with a Björk-Shiley valve but was common though usually mild with Starr-Edwards prostheses, particularly aortic valve replacements with the 2300 model and in aortic plus mitral (± tricuspid) replacements. The greater severity of haemolysis produced by Starr-Edwards valves, again especially of the latter types, was further demonstrated by higher serum lactate dehydrogenase and 24-hour urinary iron levels.
It is concluded that the Björk-Shiley tilting disc valve represents a significant advance in the amelioration of the haemolytic complications of prosthetic valves.
PMCID: PMC470215  PMID: 4450173
3.  Intermediate Term Evaluation of Starr-Edwards Ball Valves in the Mitral Position 
Texas Heart Institute Journal  1985;12(1):43-47.
The Model 6120 ball valve prosthesis introduced in 1965 is still strongly supported as a mitral valve substitute in many centers around the world. A current reassessment of the performance of this prosthesis is therefore pertinent to current medical practice.
In this institution since 1974, 227 Starr-Edwards caged ball valves have been implanted in the mitral position during isolated valve replacement. Two models of caged ball valves were used concurrently: the silastic ball valve in 108 patients (48%) and the composite strut “tract” valve in 119 (52%).
Hospital mortality was 7%, and 8-year survival (standard error) was 74 (6%), with 100% follow-up, documenting 752 total patient-years. No late deaths were known to be valve related, and there were no cases of prosthetic thrombosis. The actuarial estimate of patients free from thromboembolism at 8 years was 89 (4%) with a linearized rate of 1.3% per year. At the most recent follow-up, 95% of the patients were in the New York Heart Association (NYHA) Classes I or II. These good results were partly due to an awareness at operation of ventricular outflow tract size requirements and to strict control of postoperative anticoagulation.
We conclude that the Starr-Edwards ball valve is the mitral valve of choice in the young patient who is able to take anticoagulation drugs and has a left ventricular outflow tract of satisfactory size.
PMCID: PMC341791  PMID: 15227040
4.  Ten year clinical evaluation of Starr-Edwards 2400 and 1260 aortic valve prostheses. 
British Heart Journal  1987;57(4):356-363.
The long term performance characteristics of the 2400 and 1260 series of Starr-Edwards aortic prostheses were investigated by a follow up study of clinical outcome of 327 patients discharged from hospital with isolated aortic valve replacement. Follow up lasted for up to 10 years and was based on 1616 patient-years. The 2400 series cloth covered tracked valve was implanted in 182 patients from 1974 to 1980 and the 1260 series bare strut silastic ball valve was inserted in 145 patients from 1979 to 1983. Total 10 year mortality and valve related morbidity were low and no cases of mechanical valve failure were recorded. There were no significant actuarial differences in mortality or valve related morbidity between the 2400 and 1260 valves. Starr-Edwards models 2400 and 1260 aortic valve prostheses showed excellent durability without any mechanical failures over a 10 year period. The long term outcome of isolated aortic valve replacement with these models is associated with a low frequency of valve related complications.
PMCID: PMC1277175  PMID: 3580223
5.  Long-term Results of Aortic Valve Replacement with the Starr-Edwards Valve 
British Medical Journal  1969;1(5637):139-141.
Review of the 74 patients undergoing aortic valve replacement with a Starr–Edwards ball-valve prosthesis between October 1963 and December 1967 showed that 16 died during surgery or within the first month after operation, usually owing to myocardial failure; and there were nine late deaths. The remaining patients developed few major complications, and the long-term results of operation are considered satisfactory, no patient being grossly incapacitated and most of them are leading active, symptom-free lives.
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PMCID: PMC1982351  PMID: 5762272
6.  Extended Durability of a Cloth-Covered Star-Edwards Caged Ball Prosthesis in Aortic Position 
Case Reports in Medicine  2010;2009:165858.
The Starr-Edwards caged ball valve is one of the oldest cardiac valve prosthesis and was widely used all around the world in the past decades. Despite the long-term results that have been reported there are only a few cases reported that exceed 30 years of durability. Here in, we report a 53-year-old patient with a well-functioning 35-year-old aortic Starr-Edwards caged ball prosthesis.
doi:10.1155/2009/165858
PMCID: PMC2817501  PMID: 20148067
7.  Replacement of the Aortic and Mitral Valves Using the Starr-Edwards Ball-Valve Prosthesis 
The aortic and mitral valves were replaced in 50 patients at the University of Alberta Hospital using the Starr-Edwards ball-valve prosthesis. The basis of the selection of 20 patients for isolated aortic valve replacement and 27 for mitral valve replacement using this type of prosthesis is presented, and the techniques of insertion of the aortic and mitral valve are described in detail. Of the 27 patients in whom the mitral valve was replaced by the Starr-Edwards prosthesis six died within 30 days of surgery and two after discharge from hospital at two and a half and four months, respectively. Left atrial thrombosis was the cause of death in four of these patients. In 20 patients in whom the aortic valve was replaced, four died in hospital and two died more than 30 days after returning home. Three of these six patients died from bleeding—the result of the use of anticoagulants. The difficulty in assessing whether or not anticoagulants are needed following replacement by a Starr-Edwards prosthesis is considered. It is felt, in our present state of knowledge, that anticoagulants should be used following mitral valve replacement but are probably not essential following replacement of the aortic valve. Two patients survived replacement of both aortic and mitral valves and have been followed up 18 months and seven months, respectively.
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PMCID: PMC1927501  PMID: 14179062
8.  Left Ventricular Dynamics after Aortic Valve Replacement 
Texas Heart Institute Journal  1992;19(2):97-106.
Between January 1985 and July 1990, we studied 71 patients at our institution who underwent aortic valve replacement for either aortic valve regurgitation (40 patients) or stenosis (31 patients). The following prostheses were implanted: 25 St. Jude Medical valves (bileaflet), 16 Björk-Shiley (monoleaflet, tilting disc, 60° convexo-concave), 16 Medtronic-Hall (monoleaflet, tilting disc), and 14 Starr-Edwards (caged ball). The patients were evaluated pre-and postoperatively by means of gated blood-pool scintigraphy and Doppler echocardiography. Postoperatively, each patient was studied at 6 months, 1 year, and then annually. The evaluations focused upon 1) scintigraphically assessed left ventricular performance indicators (end-diastolic and end-systolic volume, as well as resting and exercise ejection fraction) and 2) Doppler-derived hemodynamic indexes (peak and mean transvalvular pressure gradient, effective orifice area, regurgitant flow, and systolic wall stress).
Early after aortic valve replacement, 55 (77.5%) of the patients had substantial symptomatic relief, with normal hemodynamic values both at rest and during exercise (New York Heart Association functional class I or II); another 6 patients (8.5%) maintained their preoperative status in those classes. Within a year after surgery, a majority of patients showed a significant reduction in left ventricular dimensions. The patients with preoperative aortic valve stenosis had a significantly reduced end-diastolic and end-systolic volume (p<0.05), a moderately reduced left ventricular mass index (p<0.01), and a significantly increased exercise ejection fraction (p<0.05); moreover, in all 31 of these cases, systolic wall stress returned to normal or lower-than-control values (p<0.005). The patients with preoperative aortic valve regurgitation had a significant reduction in end-diastolic and end-systolic volume (p<0.005), diastolic wall stress (p<0.005), and a significant increase in exercise ejection fraction (p<0.01); however, their left ventricular mass index was not significantly reduced.
Optimal long-term survival was afforded by the St. Jude valve in the small size (21 mm) and the Starr-Edwards valve in the large size (27 mm).
This study represents the first reported use of a serial, combined radionuclide and echocardiographic procedure for the follow-up of patients undergoing aortic valve replacement. During the 5½-year follow-up period, this combined technique proved highly accurate for collecting follow-up data, often complementing or correcting simple ultrasound results. This diagnostic approach enabled us to 1) obtain information comparable to or better than that provided by cardiac catheterization, 2) identify complications early, 3) differentiate between valvular and ventricular failure, and 4) suggest the valve of choice (not always that with the best hemodynamic performance) in patients with different cardiac variables. Further research is needed to confirm this study, the results of which could change many medical and surgical strategies for clinical management of the diseased aortic valve. (Texas Heart Institute Journal 1992; 19:97-106)
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PMCID: PMC326262  PMID: 15227421
Aortic valve insufficiency; aortic valve stenosis; echocardiography, Doppler; heart valve diseases; heart valve prosthesis; hemodynamics; radionuclide angiography; ventricular function, left
9.  Structural Failure of a Starr-Edwards Aortic Track Valve 
Texas Heart Institute Journal  1983;10(1):81-83.
Structural failure of a Model 2400 Starr-Edwards aortic track valve occurred suddenly, 4 years after implantation. At operation, the valve cage was removed from the descending aorta. Examination of the excised prosthesis disclosed minimal cloth wear and no evidence of infective growth; however, three struts were fractured above their insertion into the valve ring. To our knowledge, this type of valve malfunction has not been previously noted.
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PMCID: PMC341611  PMID: 15227160
10.  The development of the Starr-Edwards heart valve. 
Texas Heart Institute Journal  1998;25(4):282-293.
Development of the Starr-Edwards heart valve marked a new era in the treatment of valvular heart disease. Until the development of the Starr-Edwards valve, there were no published reports of patients who had lived longer than 3 months with a prosthetic valve in the mitral position. This valve was the result of a unique partnership between a young surgeon, Dr. Albert Starr, and an experienced engineer, Mr. Lowell Edwards. Working as a team, these 2 men developed and successfully implanted the 1st Starr-Edwards valve within less than 2 years of their 1st meeting. Their key to success was their willingness and ability to make repeated modifications to their design to solve each clinical problem as it arose. Their constant focus on the clinical goal aided the rapid transformation of their design from a leaflet valve to a shielded ball valve, and finally to an unshielded ball valve suitable for implantation in a human being. Along the way, they abandoned the idea of imitating the appearance of native valves, in favor of developing valves that would be clinically successful. Their work has provided help and hope for patients who otherwise would have died from the complications of rheumatic heart disease and other valvular disorders for which valve replacement is the only treatment.
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PMCID: PMC325574  PMID: 9885105
11.  Distal embolization of Edwards SAPIEN prosthesis during transcatheter aortic valve implantation 
Il Giornale di Chirurgia  2013;34(9-10):275-277.
Summary
Aim
Transcatheter aortic valve implantation (TAVI) is considered an alternative therapy in high risk patients with severe aortic stenosis. Despite this, such a minimally invasive procedure is not free from complications.
Case report
An 86-year-old woman underwent a 26-mm SAPIEN TAVI for aortic valve stenosis. Procedure was complicated by valve embolization into the ascending aorta likely due to a sub-optimal positioning of prosthesis during its deployment. Patient was treated by surgical removal of stent-valve and conventional valve replacement. Patient was discharged from hospital 7 days after surgery. At six months follow-up she was asymptomatic and the valve had a good competence with a mean transaortic gradient of 8 mmHg.
Conclusions
After TAVI prosthesis embolization, conversion to conventional surgical treatment is imperative and can be associated with excellent outcome.
PMCID: PMC3926483  PMID: 24629815
Transcatheter aortic valve implantation; Aortic valve replacement; Transfemoral aortic valve implantation
12.  Late results of aortic valve replacement with the Starr-Edwards prosthesis. 
British Heart Journal  1970;32(6):812-819.
Details are presented concerning 59 patients who left hospital between January 1964 and January 1969 after aortic valve replacement with the Starr-Edwards prosthesis. Of the 14 late deaths, 7 are known to have been due to causes related to the prosthesis and 4 to other causes. The 45 surviving patients have nearly all shown clinical improvement and only 3 are unable to work as a result of some complication of the operation. Aortic regurgitation and its consequences appear to be the most significant factor leading to symptoms. In 11 of 16 patients with anaemia there was evidence of intravascular haemolysis. The long-term consequence of this complication is not known.
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PMCID: PMC487419  PMID: 5212355
13.  Experience with the Edwards MIRA Mechanical Bileaflet Valve in the Aortic and Mitral Positions 
Texas Heart Institute Journal  2006;33(3):328-332.
The Edwards MIRA bileaflet mechanical prosthesis, a heart valve not yet available in the United States, is designed with a unique hinge mechanism, curved leaflets, and thin titanium housing. We performed this study to investigate its clinical performance and postoperative hemodynamic results.
We implanted 58 Edwards MIRA prostheses in 51 patients in the aortic (n=18), mitral (n=26), and aortic and mitral (n=7) positions. Patients' ages ranged from 25 to 84 years (mean age, 53.7 ± 13.6).
Operative mortality was 2% (n=1), and late mortality was 4% (n=2). Thromboembolic events were observed in 2 patients (valve thrombosis in 1 and a cerebrovascular event in 1). There were no complications related to anticoagulation. No signs of valvular dysfunction or paravalvular leakage were observed. Peak transvalvular gradients of the aortic prostheses ranged from 24.25 ± 5.32 mmHg for the 21-mm valve to 11 ± 1.41 mmHg for the 25-mm valve. The effective orifice area ranged from 1.99 ± 0.12 cm2 for the 21-mm valve to 2.44 ± 0.17 cm2 for the 25-mm valve. The mean transvalvular gradients of the mitral prostheses ranged from 5.85 ± 2.91 mmHg for the 27-mm valve to 4.5 ± 0 mmHg for the 31-mm valve. The effective orifice area ranged from 2.31 ± 0.03 cm2 for the 27-mm valve to 2.64 ± 0.05 cm2 for the 33-mm valve.
These preliminary data suggest good hemodynamic function and a low rate of valve-related complications in the use of the Edwards MIRA mechanical prosthesis.
PMCID: PMC1592271  PMID: 17041690
Aortic valve/surgery; cerebrovascular disorders/etiology; embolism; heart valve diseases/surgery; heart valve prosthesis; mitral valve/surgery; postoperative complications; prosthesis design; prosthesis failure; thrombosis
14.  Closing sounds and related complaints after heart valve replacement with St Jude Medical, Duromedics Edwards, Björk-Shiley Monostrut, and Carbomedics prostheses. 
British Heart Journal  1992;67(6):460-465.
OBJECTIVE--To measure the noise produced and related subjective complaints after implantation of four different mechanical heart valve prostheses and to identify further factors related to the patient and prosthesis that influence noise generation and complaints. DESIGN--Sound pressure was measured 5 and 10 cm and 1 m from the point of maximal impulse on the body surface by a calibrated meter in quiet rooms with either a decibel(A) filter or octave filters. The patients were asked about their complaints and examined physically. SETTING--The measurements were conducted in silent rooms of ear, nose, and throat departments. The patients had been operated on either in a university hospital or a community hospital. MAIN OUTCOME MEASURES--Sound pressures of frequency bands and sound pressures measured in dB(A) at various distances. Complaints registerd were: sleep disturbance, disturbance during daytime, "wants a less noisy prosthesis," and "can hear the closing click". PATIENTS--143 patients after heart valve replacement with St Jude Medical (n = 35), Duromedics Edwards (n = 38), Carbomedics (n = 34) and Björk-Shiley Monostrut (n = 36) prostheses operated on between 1984 and 1988 were matched for valve position, ring size, and body surface area. RESULTS--Duromedics Edwards (33.5 (6) dB(A)) and Björk-Shiley Monostrut valves (31 (4) dB(A)) were significantly louder than St Jude Medical (24 (4) dB(A)) and Carbomedics (25 (6) dB(A)) prostheses (p = 0.0001) (mean (SD)). The louder valves were significantly more often heard by the patients (p = 0.0012) and caused more complaints both during sleep (p = 0.024) and during the daytime (p = 0.07). Patients with these valves were more likely to want a less noisy valve (p = 0.0047). Patients with symptoms were younger, had better hearing, and were more likely to be in sinus rhythm. As well as the type of prostheses, the valve diameter and body height also had an effect on sound emission. CONCLUSIONS--The intensity of the closing click of mechanical valve prostheses was significantly different for various designs. Patient complaints were related to the objectively measured sound pressure. Noise production should be considered when a mechanical valve is selected.
PMCID: PMC1024887  PMID: 1622695
15.  Structural valve deterioration of a mitral Carpentier-Edwards pericardial bioprosthesis in an 87-year-old woman 16 years after its implantation 
The second-generation pericardial valve, the Carpentier-Edwards perimount bioprosthetic (CEP) valve, shows dramatically improved durability as compared to the first-generation pericardial valve, and excellent performance has been obtained, in both the aortic and mitral positions. Especially in elderly patients with an implanted CEP valve, reoperation due to structural valve deterioration (SVD) is rarely required. Here, we report the case of an 87-year-old woman with an explanted CEP valve in the mitral position due to SVD, 16 years after its implantation.
doi:10.1186/1749-8090-6-88
PMCID: PMC3149574  PMID: 21729285
16.  Repeated mitral valve replacement in a patient with extensive annular calcification 
Background
Mitral valve replacement in the presence of severe annular calcification is a technical challenge.
Case report
A 47-year-old lady who had undergone mitral and aortic valve replacement for rheumatic disease 27 years before presented with dyspnea. At reoperation, extensive mitral annular calcification was hindering the disc motion of the Starr-Edwards mitral prosthesis. The old prosthesis was removed and a St Jude Medical mechanical valve was implanted after thorough annular debridement. Postoperatively the patient developed paravalvular leak and hemolytic anemia, subsequently undergoing reoperation three days later. The mitral valve was replaced with an Edwards MIRA valve, with a bulkier sewing cuff, after more aggressive annular debridement. Although initially there was no paravalvular leak, it recurred five days later. The patient also developed a small cerebral hemorrhage. As the paravalvular leak and hemolytic anemia gradually worsened, the patient underwent reoperation 14 days later. A Carpentier-Edwards bioprosthetic valve with equine pericardial patches, one to cover the debrided calcified annulus, another as a collar around the prosthesis, was used to eliminate paravalvular leak. At 7 years postoperatively the patient is doing well without any evidence of paravalvular leak or structural valve deterioration.
Conclusion
Mitral valve replacement using a bioprosthesis with equine pericardial patches was useful to overcome recurrent paravalvular leak due to severe mitral annular calcification.
doi:10.1186/1749-8090-6-149
PMCID: PMC3226642  PMID: 22082310
Mitral valve replacement; Annular calcification; Surgical procedures
17.  Chronic haemolysis after Lillehei-Kaster valve replacement. Comparison with the findings after Björk-shiley and Starr-Edwards mitral valve replacement. 
Thorax  1980;35(4):290-293.
Nineteen female and sixteen male patients who have had their heart valves replaced with Lillehei-Kaster valves were investigated for haemolysis four to 18 months after operation. Investigation included serum lactic dehydrogenase, serum haptoglobins, and urine haemosiderin. Red cells survival, using autologous red cells labelled with 51Cr, was measured in 12 patients. No patient showed manifest anaemia. The serum lactic dehydrogenase levels were raised in 66% of the mitral valve patients, 81% of the aortic valve patients, and in all the double valve patients. The serum haptoglobins were decreased in 66% of mitral patients, 68% of aortic valve patients, and in 75% of the double valve patients. All the 12 patients studied had lower than normal red cell survivals. No correlation was found between the incidence of haemolysis and the size of the valve. In isolated mitral valve replacement 66% showed compensated haemolysis compared with 42% in Björk-Shiley valves (p less than 0.05), 85% in Starr-Edwards valves (composite seat) (p less than 0.01), and none in frame-mounted irradiated homografts (previous study) (p less than 0.001).
PMCID: PMC471272  PMID: 7434271
18.  Thrombo-embolic complications of the cloth-covered Starr-Edwards prostheses No. 2300 aortic and No. 6300 mitral 
Thorax  1973;28(1):41-47.
The thrombo-embolic complications of the cloth-covered Starr-Edwards prostheses No. 2300 aortic and No. 6300 mitral followed for an average of 14 months in 155 patients are reviewed. There was a high incidence of early fatal and disabling thrombo-embolus in patients having mitral valve replacement. Late emboli were more common after aortic valve replacement. Anticoagulant control was unsatisfactory and not without hazards.
PMCID: PMC469989  PMID: 4685210
19.  Totally biological composite aortic stentless valved conduit for aortic root replacement: 10-year experience 
Objectives
To retrospectively analyze the clinical outcome of a totally biological composite stentless aortic valved conduit (No-React® BioConduit) implanted using the Bentall procedure over ten years in a single centre.
Methods
Between 27/10/99 and 19/01/08, the No-React® BioConduit composite graft was implanted in 67 patients. Data on these patients were collected from the in-hospital database, from patient notes and from questionnaires. A cohort of patients had 2D-echocardiogram with an average of 4.3 ± 0.45 years post-operatively to evaluate valve function, calcification, and the diameter of the conduit.
Results
Implantation in 67 patients represented a follow-up of 371.3 patient-year. Males were 60% of the operated population, with a mean age of 67.9 ± 1.3 years (range 34.1-83.8 years), 21 of them below the age of 65. After a mean follow-up of 7.1 ± 0.3 years (range of 2.2-10.5 years), more than 50% of the survivors were in NYHA I/II and more than 60% of the survivors were angina-free (CCS 0). The overall 10-year survival following replacement of the aortic valve and root was 51%. During this period, 88% of patients were free from valved-conduit related complications leading to mortality. Post-operative echocardiography studies showed no evidence of stenosis, dilatation, calcification or thrombosis. Importantly, during the 10-year follow-up period no failures of the valved conduit were reported, suggesting that the tissue of the conduit does not structurally change (histology of one explant showed normal cusp and conduit).
Conclusions
The No-React® BioConduit composite stentless aortic valved conduit provides excellent long-term clinical results for aortic root replacement with few prosthesis-related complications in the first post-operative decade.
doi:10.1186/1749-8090-6-86
PMCID: PMC3145569  PMID: 21699696
aorta and aortic valve disease; aortic valved conduit; aortic root replacement; Bentall's operation; BioConduit; detoxified tissue; homografts; autografts
20.  Acute dysfunction of Starr-Edwards mitral prostheses 
Thorax  1971;26(2):163-166.
Four cases of acute dysfunction of Starr-Edwards mitral prostheses are recorded. The patients presented with sudden dysponea 4 to 18 months after apparently successful mitral valve replacement. The prosthetic valve dysfunction was caused by thrombus on the bare metal cage of the prosthesis. No warning thromboembolic phenomena had been recorded. Urgent replacement of the valve resulted in the survival of one patient.
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PMCID: PMC1019120  PMID: 5576532
21.  Surgical Management of Aortic Root Dilatation with Advanced Aortic Regurgitation: Bentall Operation versus Valve-sparing Procedure 
Background
Although the aortic valve-sparing procedure has gained popularity in recent years, it still remains challenging in patients with advanced aortic regurgitation (AR). We compared the long-term outcomes of the aortic valve-sparing procedure with the Bentall operation in patients with advanced aortic regurgitation secondary to aortic root dilatation.
Materials and Methods
A retrospective review of 120 patients who underwent surgery for aortic root dilatation with moderate to severe AR between January 1999 and June 2009 was performed. Forty-eight patients underwent valve-sparing procedures (valve-sparing group), and 72 patients underwent the Bentall procedure (Bentall group). The two groups' overall survival, valve-related complications, and aortic valve function were compared.
Results
The mean follow-up duration was 4.9±3.1 years. After adjustment, the valve-sparing group had similar risks of death (hazard ratio [HR], 0.61; p=0.45), and valve related complications (HR, 1.27; p=0.66). However, a significant number of patients developed moderate to severe AR in the valve-sparing group at a mean of 4.4±2.5 years of echocardiographic follow-up (p<0.001).
Conclusion
Both the Bentall operation and aortic valve-sparing procedure showed comparable long-term clinical results in patients with advanced aortic regurgitation with aortic root dilatation. However, recurrent advanced aortic regurgitation was more frequently observed following valve-sparing procedures.
doi:10.5090/kjtcs.2012.45.3.141
PMCID: PMC3373968  PMID: 22708080
Aortic root; Aortic valve insufficiency; Bentall operation; Aortic valve repair
22.  Mitral valve replacement with ball valve prostheses 
British Heart Journal  1971;33(Suppl):47-55.
Our experience with ball valve replacement of the mitral valve during the past decade is presented in terms that allow comparison with other techniques. The use of such prostheses is characterized by ease of implantation, with an overall operative mortality of 11 per cent for isolated mitral replacement and 13 per cent for multiple valve replacement. The operative mortality for isolated mitral valve replacement during 1969 and thus far in 1970 has been nil. The late mortality was 13 per cent for isolated mitral replacement and 20 per cent for multiple valve replacement. Forty-three per cent of the total late deaths were clearly unrelated to the prosthetic device itself.
The overall incidence of late infection and leak is less than 1 per cent and the immediate haemodynamic benefit is not altered by loss of structural integrity of the prosthesis.
The most serious problem after mitral valve replacement with the ball valve prosthesis is that of thromboembolic complications. While thrombotic stenosis of the prosthesis is a rarity, embolic episodes, usually cerebral in type, have been noted in 63 per cent of the patients surviving mitral valve replacement with the earliest model ball valve from August 1960 to February 1966. Improvements in valve design have resulted in a remarkable decrease in this incidence as examined by actuarial techniques and taking into account the duration of follow-up. The extension of the cloth sewing margins to the orifice of the valve while maintaining a metallic orifice and metallic cage (Model 6120) resulted in a drop of the thromboembolic rate to 17 per cent from April 1965 to April 1969.
The development of the totally cloth-covered prosthesis has further improved these results, with only one thromboembolic complication after isolated mitral valve replacement with the Model 6310 valve in a series of 66 consecutive patients. In clinical practice this has resulted in the avoidance of the use of anticoagulant therapy in patients in whom for a variety of reasons this carries an increased hazard. With further follow-up it may be possible to discontinue the routine use of anticoagulants.
Images
PMCID: PMC503271  PMID: 5572646
23.  Total Replacement of the Mitral Valve: Results of Insertion of a Starr-Edwards Valve in Five Patients 
In five patients the mitral valve was resected and total valve replacement undertaken. The Starr-Edwards prosthesis was inserted. The first patient died, two and one-half months after operation, of a wide massive left-atrial clot and peripheral embolization. The second and third patients are well and back at work at eight months after operation, and the fourth patient is well at two and one-half months after operation. The fifth patient died suddenly at three weeks from massive peripheral embolization originating from the left side of the heart. The technical details of the insertion of the valves are described and the importance of careful postoperative anticoagulant management is stressed.
Images
PMCID: PMC1921405  PMID: 14017893
24.  Premature valve closure in patients with a mitral Starr-Edwards prosthesis and aortic incompetence 
British Heart Journal  1970;32(4):436-439.
A mitral Starr-Edwards ball valve has, in three patients with concomitant aortic incompetence, permitted recognition of intermittent premature valve closure by auscultation and this has been documented by phonocardiograms. In two instances the observations were confirmed during cardiac catheterization. The features of premature Starr valve closure are described and the mechanism is discussed.
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PMCID: PMC487349  PMID: 5433303
25.  Pregnancy in patients after valve replacement. 
British Heart Journal  1976;38(11):1140-1148.
This report is based on information obtained from a questionnaire sent to major cardiac centres in the United Kingdom. This produced details of 39 pregnancies in 34 patients after valve replacement. The 39 pregnancies gave rise to 30 healthy babies. The small size of the series probably reflects both the increasing rarity of young women with rheumatic heart disease in this country and the cautious attitude of their cardiologists. This makes it likely that these women represented the best end of the spectrum of cardiac function after valve replacement. Twenty-four pregnancies in 20 women who were not given anticoagulants producted 23 healthy babies and 1 spontaneous abortion. This group comprised 6 patients with free aortic homografts, 1 patient with a fascia lata mitral valve, 1 with a Beall tricuspid prosthesis, 1 with a combined mitral homograft and Starr Edwards aortic prosthesis, and 1 with mitral and aortic frame-mounted fascia lata valves. There were no maternal deaths or thromboembolic complications in this group which included 5 patients who were in atrial fibrillation. Fifteen pregnancies in 14 women who received anticoagulants gave rise to 7 healthy babies. The fetal losses were one stillbirth, one intrauterine death at 34 weeks, and 3 spontaneous abortions; one surviving child has hydrocephalus as a result of blood clot and there were 2 maternal deaths. This group included 13 patients with Starr Edwards valves, 11 mitral and 2 aortic. A patient with a Hammersmith mitral valve was the only one to have been treated with heparin and her valve thrombosed. One patient with a mounted mitral homograft had a cerebral embolus. Nine of these patients were in atrial fibrillation. In 3 additional patients the valve replacement was carried out during pregnancy. Two of the patients survived operation. In one of these who was treated with warfarin the pregnancy well, but there is an increased fetal wastage in patients pregnancy gave rise to a congenitally malformed baby who died in the neonatal period. The baby born to the mother who did not receive anticoagulants has a hare-lip and talipes. Women with artificial valves can tolerate the haemodynamic load of pregnancy well, but there is an increased fetal wastage in patients taking oral anticoagulants. This is probably largely attributable to fetal haemorrhage but there is also a risk of malformation caused by a teratogenic effect of warfarin. Experience gained in non-pregnant patients suggests that withholding anticoagulatns in pregnant patients with prosthetic valves would usually be undersirable but warfarin should be avoided. The advantages of biological valves were apparent in this series.
PMCID: PMC483146  PMID: 1008955

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