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Jude Medical Prosthesis and Fixed Dose Anticoagulation

T1 - Hemodynamics and early clinical performance of the St. Jude Medical Regent mechanical aortic valve

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Jude Medical mechanical prosthesis.

N2 - Thrombosis of both valve leaflets of a St. Jude Medical tricuspid cardiac prosthesis, resulting in valvular dysfunction, was detected by systolic and diastolic tricuspid murmurs and confirmed by M-mode and two-dimensional echocardiograms. Thrombus formation at both hinge points of the bileaflet valve caused one leaflet to stick in the nearly closed position and the other to have severely impeded motion. Thrombotic involvement of both valve leaflets, not previously reported, occurred in a 17-year-old boy who has undergone six prosthetic cardiac valvular replacements in the past 2 years. Failure to achieve adequate anticoagulation in the early postoperative period appears to be related to the thrombosis in this case.

T1 - Hemodynamics and early performance of the St. Jude Medical Regent™ aortic valve prosthesis

Bioprostheses have become increasingly popular for aortic valve replacement (AVR) in recent years, but mechanical valves are still the standard choice, especially for younger patients. The aim of this study was to assess the very long-term outcomes in Japanese patients who underwent AVR with St. Jude Medical (SJM) mechanical valves.

Jude and Medtronic Hall prosthesis.

Jude Medical mechanical valve prosthesis

The hemodynamic function of the 19 mm and 21 mm St Jude Medical valve prostheses in the aortic position was evaluated in seven patients who had valve replacement for either severe aortic stenosis or regurgitation an average of 4 months after operation. Cardiac output and simultaneous transvalvular gradient were recorded at rest and during moderate supine arm exercise. The average peak systolic gradient was 14 mm Hg (range 0 to 25 mm Hg) at rest and 32 mm Hg (range 23 to 56 mm Hg) with exercise. The average mean systolic gradient was 20 mm Hg (range 10 to 28 mm Hg) at rest and 38 mm Hg (range 30 to 48 mm Hg) with exercise. The mean effective orifice area was 1.2 cm2 (range 0.9 to 1.4 cm2) at rest and 1.1 cm2 (range of 0.9 to 1.3 cm2) with exercise. Mean cardiac output at rest was 4.4 L/min, and, with exercise, 7.4 L/min. Of the five valves evaluated with root aortography, four demonstrated trivial and one mild aortic insufficiency. We conclude that the St Jude Medical valve prosthesis in the aortic position has favorable hemodynamic function which is particularly evident in the 19 mm and 21 mm sizes when compared with other currently available aortic valve prostheses.

Thrombosis of both valve leaflets of a St. Jude Medical tricuspid cardiac prosthesis, resulting in valvular dysfunction, was detected by systolic and diastolic tricuspid murmurs and confirmed by M-mode and two-dimensional echocardiograms. Thrombus formation at both hinge points of the bileaflet valve caused one leaflet to stick in the nearly closed position and the other to have severely impeded motion. Thrombotic involvement of both valve leaflets, not previously reported, occurred in a 17-year-old boy who has undergone six prosthetic cardiac valvular replacements in the past 2 years. Failure to achieve adequate anticoagulation in the early postoperative period appears to be related to the thrombosis in this case.

Jude Medical cardiac valve prosthesis.

Jude Medical prosthesis in 1200 patients

N2 - The hemodynamic function of the 19 mm and 21 mm St Jude Medical valve prostheses in the aortic position was evaluated in seven patients who had valve replacement for either severe aortic stenosis or regurgitation an average of 4 months after operation. Cardiac output and simultaneous transvalvular gradient were recorded at rest and during moderate supine arm exercise. The average peak systolic gradient was 14 mm Hg (range 0 to 25 mm Hg) at rest and 32 mm Hg (range 23 to 56 mm Hg) with exercise. The average mean systolic gradient was 20 mm Hg (range 10 to 28 mm Hg) at rest and 38 mm Hg (range 30 to 48 mm Hg) with exercise. The mean effective orifice area was 1.2 cm2 (range 0.9 to 1.4 cm2) at rest and 1.1 cm2 (range of 0.9 to 1.3 cm2) with exercise. Mean cardiac output at rest was 4.4 L/min, and, with exercise, 7.4 L/min. Of the five valves evaluated with root aortography, four demonstrated trivial and one mild aortic insufficiency. We conclude that the St Jude Medical valve prosthesis in the aortic position has favorable hemodynamic function which is particularly evident in the 19 mm and 21 mm sizes when compared with other currently available aortic valve prostheses.

AB - The hemodynamic function of the 19 mm and 21 mm St Jude Medical valve prostheses in the aortic position was evaluated in seven patients who had valve replacement for either severe aortic stenosis or regurgitation an average of 4 months after operation. Cardiac output and simultaneous transvalvular gradient were recorded at rest and during moderate supine arm exercise. The average peak systolic gradient was 14 mm Hg (range 0 to 25 mm Hg) at rest and 32 mm Hg (range 23 to 56 mm Hg) with exercise. The average mean systolic gradient was 20 mm Hg (range 10 to 28 mm Hg) at rest and 38 mm Hg (range 30 to 48 mm Hg) with exercise. The mean effective orifice area was 1.2 cm2 (range 0.9 to 1.4 cm2) at rest and 1.1 cm2 (range of 0.9 to 1.3 cm2) with exercise. Mean cardiac output at rest was 4.4 L/min, and, with exercise, 7.4 L/min. Of the five valves evaluated with root aortography, four demonstrated trivial and one mild aortic insufficiency. We conclude that the St Jude Medical valve prosthesis in the aortic position has favorable hemodynamic function which is particularly evident in the 19 mm and 21 mm sizes when compared with other currently available aortic valve prostheses.

Jude medical aortic and mitral prosthesis
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AB - Thrombosis of both valve leaflets of a St. Jude Medical tricuspid cardiac prosthesis, resulting in valvular dysfunction, was detected by systolic and diastolic tricuspid murmurs and confirmed by M-mode and two-dimensional echocardiograms. Thrombus formation at both hinge points of the bileaflet valve caused one leaflet to stick in the nearly closed position and the other to have severely impeded motion. Thrombotic involvement of both valve leaflets, not previously reported, occurred in a 17-year-old boy who has undergone six prosthetic cardiac valvular replacements in the past 2 years. Failure to achieve adequate anticoagulation in the early postoperative period appears to be related to the thrombosis in this case.

St. Jude Medical mitral prosthesis - YouTube

Surgically related PVL due to inadequate suturing technique and knot slippage occurs immediately after valve replacement and can, in some cases, be prevented by the use of mattress sutures bolstered with pledgets to sandwich valvular-annular tissue between the pledgeted sutures. Diagnosing PVLs is often difficult because the associated murmur is often soft, and transthoracic images and color flow Doppler may be hindered by the prosthesis and the presence of significant valvular calcification. Transesophageal echocardiography (TEE) provides greater sensitivity and specificity in detecting PVLs and differentiation from transvalvular regurgitation and is essential for any symptomatic patient in whom a PVL is suspected.3

Jude Medical bileaflet valve prosthesis

Despite medical therapies, however, many patients will continue to experience worsening NYHA functional class and intractable hemolytic anemia, necessitating reoperation. Unfortunately, repeat surgery is often unsuccessful, with a high incidence of recurrence as the original anatomical problems persist, resulting in reformation of PVLs.8 Furthermore, these patients are generally sicker than at the time of the index surgical procedure, and therefore, reoperation carries markedly higher morbidity and mortality rates (Table 1). In a case series by Akins et al, a total of 136 patients underwent surgical correction of a PVL (32% aortic and 68% mitral, 48% primary repair and 52% replacement of prosthesis), and the operative mortality and preoperative stroke rates were 6.6% and 5.1%, respectively.4 Ten-year mortality in that series was 70%, with similar perioperative and long-term mortality rates reported by other investigators.5,6

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The first successful transcatheter closure of PVLs was reported by Hourihan and colleagues in 1992 with the use of the Rashkind double-umbrella closure technique. 9 No specific device has since been developed or approved by the US Food and Drug Administration for percutaneous PVL repair. Therefore, the choice of percutaneous therapeutic options is limited to the offlabel use of closure devices designed for repair of other cardiac defects. The Amplatzer family of closure devices (St. Jude Medical, Inc., St. Paul, MN), including the septal occluder, VSD muscular occluder, duct occluder, and vascular plugs, has gained favor and are the devices most commonly used off-label for transcatheter PVL repair.10 In the United States, the Amplatzer Vascular Plugs (AVP) II and IV (St. Jude Medical, Inc.) are commonly used. The AVP IV has the advantage of being delivered through a 0.038-inch diagnostic catheter lumen and can be placed in very serpiginous and longtunnel PVLs, such as those that occur after transcatheter aortic valve replacement. The AVP III device (St. Jude Medical, Inc.) has a thin rectangular shape that is designed to conform to a crescent-shaped PVL defect and has been used with success, although it is not currently available in the United States. Device selection and sizing requires careful examination of the PVL anatomy, specifically the diameter and length of the defect, and its relationship to the surrounding cardiac structures.

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