A 5½ year experience with the St. Jude Medical cardiac valve prosthesis (original) (raw)
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St. Jude medical valve prosthesis: An analysis of long-term outcome and prognostic factors
The Journal of Thoracic and Cardiovascular Surgery, 1997
replacements). Follow-up was 96% complete (2967 patient-years; mean 9.5 years per patient). Actuarial event-free rates at 10 years and linearized rates (in parentheses) of late complications were as follows: embolism, 85.0%-2.3% (2.3% per patient-year); anticoagulant-related hemorrhage, 74.8%-2.7% (3.3% per patient-year); cerebrovascular accident, 81.8%-+ 2.5% (2.6% per patient-year); prosthesis thrombosis, 98.5%-0.7% (0.1% per patient-year); endocarditis, 97.2%-1.1% (0.4% per patient-year); prosthesis dysfunction, 97.1%-+ 1.0% (0.4% per patient-year); hemolytic anemia, 98.5%-+ 0.7% (0.1% per patient-year); reoperation, 97.4% + 1.0% (0.4% per patient-year); overall mortality, 63.3%-2.7% (4.2% per patientyear); and valve-related death (including sudden death), 84.7%-+ 2.2% (1.4% per patient-year). Independent preoperative risk factors were as follows: (1) for embolism, cardiac failure as indication for operation and history of prior systemic embolism; (2) for cerebrovascular accidents, the same two factors and age; (3) for endocarditis, diabetes, chronic alcoholism, and aortic valve replacement; (4) for overall mortality, age, ejection fraction (or cardiac index or cardiothoracic index), chronic alcoholism, and history of systemic embolism; and (5) for valve-related death, chronic alcoholism, degenerative cause of valve disease, and prosthetic diameter 23 mm or smaller. Ninety percent of survivors were in New York Heart Association functional class I or II at the end of follow-up. In conclusion, this study confirms the excellent durability of the St. Jude Medical valve and the remarkable functional benefit for the majority of the patients. However, prosthesis-related complications are still common, particularly for small-diameter prostheses. Outcome is strongly related to the patient's preoperative cardiac condition and to the adequacy of anticoagulation control.
The Journal of Thoracic and Cardiovascular Surgery, 1994
years. Preoperatively, 830 patients (69%) were in functional class III or IV. A total of 611 patients (51 %) had the aortic valve replaced, 490 (41 %) the mitral valve, 2 (0.2 %) the tricuspid valve, and 97 (8 %) multiple valves. There were 81 hospital deaths (6.8 %). Risk factors included older age (p = 0.0001), female gender (p = 0.02), higher preoperative left ventricular end-diastolic pressure (p = 0.05), previous cardiac operation (p = 0.003), longer aortic crossclamp time (p = 0.0001), and longer cardiopulmonary bypass time (p = 0.0001). FoUow-up was 98% complete (3153 patient-years). There were 152 late deaths; 32 (21 %) were considered valve-related: six thromboembolism, four valve thrombosis, five anticoagulant-related hemorrhage, eight prosthetic valve endocarditis, one paravalvular leak, and seven sudden death. The 5-year actuarial survival was 75 %. Risk factors for late death included older age (p = 0.03), lower preoperative ejection fraction (p = 0.005), longer aortic crossclamp time (p =0.0001), longer cardiopulmonary bypass time (p =0.0001), previous cardiac operation (p = 0.02), and higher preoperative functional class (p = 0.0001). Actuarial freedom at 5 years from major thromboembolic events and anticoagulant-related hemorrhage was 97 % and 95 %, respectively. This value for valve thrombosis was 99%, for reoperation 96%, for prosthetic valve endocarditis 98%, and for paravalvular leak 96 %. Actuarial freedom from aU valve-related events and valve-related death at 5 years was 74% and 94%, respectively. We conclude that the low incidence of valve-related events and low mortality supports the continued use of the St.
Initial Experimental Experience with a “Replaceable” Cardiac Valve Prosthesis
Annals of Thoracic Surgery, 1988
An easily "replaceable" cardiac valve prosthesis has been designed. It consists of two parts: (1) a sewing ring incorporating a circlip and (2) a functioning valve (either mechanical or tissue). The circlip is encased in a sewing ring, which is sutured into the natural valve annulus, and grips the functional part of the prosthesis, thereby preventing dislodgment. A simple instrument has been designed to open the circlip a few millimeters to allow easy removal or insertion of the functional element. This sewing ring/circlip with the functional element of a Bjork-Shiley prosthesis was used in 10 baboons undergoing mitral valve replacement. Removal and replacement of the functional element was carried out at a second operation between 1 and 12 weeks later. There were no operative deaths. Baboons were electively killed one day to twelve months after the second operation. There were no complications related to the prosthesis; cardiac catheterization showed normal hemodynamics before and after the second operative procedure.
Circulation, 2001
Background-In this retrospective study, Ϸ440 patients received mitral valve replacements with the St Jude Medical prothesis. The last patient was operated on 10 years before the beginning of the follow-up. The extended follow-up was 19 years. Methods and Results-Four hundred forty patients (sex ratio, 1.32 [men to women]; age, 60Ϯ11.4 years; age range, 7 to 75 years) were operated on from 1979 to 1987. All patients underwent isolated mitral valve replacement. Tricuspid plasty was the only associated procedure. The follow-up at 19 years was 98% complete. The overall actuarial survival rate was 63Ϯ3.3% at 19 years, and the actuarial survival rate (only valve related) was 83Ϯ2.7%. The operative mortality rate (0 to 30 days) was 4.09%. We found that 89.4% of the patients alive at 19 years were in NYHA class I/II. Multivariate analysis showed that age and sex were significantly correlated with valve-related mortality and that age, sex, NYHA class, and atrial fibrillation were significantly correlated with overall mortality. The linearized rates (percent patient-years) of thromboembolism, thrombosis, and hemorrhage were 0.69, 0.2, and 1, respectively. At 19 years, freedom from endocarditis and reoperation was 98.6Ϯ1% and 90Ϯ3%, respectively. Conclusions-In this study, the very-long-term results confirm the excellent durability of the St Jude Medical prosthesis in the mitral position and show the difficulty of adjusting the anticoagulation protocol, even after long-term treatment.
Up to eight years’ follow-up of 997 patients receiving the CarboMedics prosthetic heart valve
Annals of Thoracic Surgery, 1998
heart valve Up to eight years' follow-up of 997 patients receiving the CarboMedics prosthetic http://ats.ctsnetjournals.org/cgi/content/full/66/2/443 on the World Wide Web at: The online version of this article, along with updated information and services, is located Print ISSN: 0003-4975; eISSN: 1552-6259. Southern Thoracic Surgical Association. Background. The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis. Methods. Nine hundred ninety-seven consecutive patients underwent mechanical valve implantation (aortic, 771; mitral, 169; double, 52; tricuspid, 5) with this prosthesis from September 1987 through December 1993. The mean age was 62.3 ؎ 13.7 years (range, 0.4 to 84 years); 56.6% (564 patients) were men. Four hundred seventy patients (47.1%) underwent additional surgical procedures. Mean follow-up was 4.1 ؎ 2.2 years (range, 0 to 8.3 years) with a total of 4,040 patient-years. Results. Early mortality was 5.0% (50/997; aortic, 4.4%; mitral, 6.4%; double, 9.6%). Late mortality was 14.8% (140/947). Survival at 7 years was 75.9% ؎ 1.8% (aortic, 78.4% ؎ 2%; mitral, 70.7% ؎ 4.5%; double, 60.8% ؎ 7.4%).
Ten-year experience with the St. Jude Medical valve for primary valve replacement
The Journal of Thoracic and Cardiovascular Surgery, 1990
Ten-year experience with the 81. Jude Medical valve for primary valve replacement The St. Jude Medical valve is a bileaftet prosthesis with excellent hemodynamic characteristics, but the long-tenn surgical experience with this valve, its durability, and its biocompatibility are unknown. During a IO-year period from March 1978 to 1988, 690 prostheses (290 aortic, 252 mitral, and 74 double aortic-mitral) were inserted as the initial valve replacement substitute in 616 patients (mean age 63 years). Coronary atherosclerosis was present in 58 %. Follow-up totaled 2031 patient-years (mean 3.3 years) and was 95% complete (32 lost), Early (3O-day) mortality rates were 5.2%, 11.9%, and 8.1 % after aortic, mitral, and double valve replacement; 5and 9-year actuarial survival rates were 71 % ± 3% and 51 % ± 8%, 59% ± 4% and 41 % ± 6%, and 69% ± 6% and 47% ± 15%, respectively. Deaths were associated with extensive coronary atherosclerosis (p < 0.001). older age (p < 0.001~advanced preoperative New York Heart Association functional class (p < O.O~and malignant ventricular arrhythmias (p < 0.05). No structural failures have been observed. Embolism (40 events) occurred at a rate of 2.0% jpt-yr (2.3% aortic, 1.6% mitral, 2.0% double). There were six cases of valve thrombosis (0.3% jpt-yr; one fatal). Hemorrhage was the most frequent complication (2.6 % jpt-yr); 13 (25 %) of 52 events were fatal, accounting for 62 % of all valve-related deaths. After the target prothrombin time ratio was lowered, the rate of hemorrhage decreased by 44 % (2.7% to 1.5 % jpt-yr). while the combined rate of embolism and valve thrombosis increased slightly (2.2 % to 2.5% jpt-yr, a 14% change). In summary, the St. Jude Medical valve remains a durable valve substitute. Survival was strongly related to the presence of associated coronary atherosclerosis. The most common complication has been hemorrhage; a less intensive warfarin regimen may reduce hemorrhagic risk while maintaining thromboembolic protection.
Mid-term follow-up and outcomes of patients with prosthetic heart valves: a single-centre experience
Echo Research & Practice
Background Patients with prosthetic heart valves (PHV) require long-term follow-up, usually within a physiologist led heart valve surveillance clinic. These clinics are well established providing safe and effective patient care. The disruption of the COVID-19 pandemic on services has increased wait times thus we undertook a service evaluation to better understand the patients currently within the service and PHV related complications. Methods A clinical service evaluation of the heart valve surveillance clinic was undertaken to assess patient demographics, rates of complications and patient outcomes in patients who had undergone a PHV intervention at our institute between 2010 and 2020. Results A total of 294 patients (mean age at time of PHV intervention: 71 ± 12 years, 68.7% male) were included in this service evaluation. Follow-up was 5.9 ± 2.7 years (range: 10 years). 37.1% underwent baseline transthoracic echo (TTE) assessment and 83% underwent annual TTE follow-up. Significant...