We have previously reported that long-term therapy with warfarin is effective for preventing recurrent venous thromboembolism in patients with proximal-vein thrombosis but that there is an appreciable risk of hemorrhage. To determine whether that risk could be reduced without a loss of effectiveness, we randomly allocated 96 patients with proximal-vein thrombosis to a group receiving less intense anticoagulant therapy, with a mean prothrombin time of 26.9 seconds using the Manchester comparative reagent (corresponding Simplastin time, 15 seconds), or a group given more intense therapy, with a mean Simplastin time of 19.4 seconds (corresponding prothrombin time 41 seconds with the Manchester comparative reagent) (P less than 0.001). Two of 47 patients (4 per cent) in the less intensely treated group had hemorrhagic complications, as compared with 11 of 49 patients (22 per cent) in the more intensely anticoagulated group (P = 0.015 by the two-tailed test). This difference was due to minor bleeding episodes. The frequency of recurrent venous thromboembolism was low in both groups (2 per cent). Our findings indicate that less intense anticoagulant therapy is associated with a low frequency of recurrent venous thromboembolism (2 per cent) and a reduced risk of hemorrhage.
Background-Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. PϽ0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was observed in 93.8%. The incidence of valve embolization was 0.3% (nϭ3), and coronary obstruction was reported for 0.6% (nϭ6 cases). Incidence of stroke was 2.5% and similar for both procedural approaches. Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients. The occurrence of vascular complications was not a predictor of Ͻ30-day mortality in the transfemoral population. Conclusion-Technical proficiency can be learned and adapted readily as demonstrated by the short-term procedural success rate and low 30-day mortality rates reported in the SOURCE Registry. Specific complication management and refinement of patient selection are needed to further improve outcomes. (Circulation. 2010;122:62-69.)
This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients. (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [SAPIEN3]; NCT01808287).
The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients.
Background-Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement.
Methods and Results-The
Surgical aortic valve replacement remains the therapy of choice in majority of patients with aortic stenosis. Bioprosthetic heart valves are often preferred over mechanical valves as they preclude the need for anticoagulation with its associated risks of bleeding and thromboembolism. However, bioprosthetic heart valves undergo structural deterioration and eventually fail. Reoperation is the standard treatment for structural failure of the bioprosthetic valve, stenosis or regurgitation but can carry a significant risk, especially in elderly patients with multiple comorbidities. Transcatheter aortic valve implantation has recently been established as a feasible alternative to conventional valve surgery for the management of high-risk elderly patients with aortic stenosis. This treatment modality has also been shown to be of benefit in the management of degenerated aortic bioprosthesis as a valve-in-valve procedure. The success of this procedure depends on a good understanding of the failing bioprostheses. This not only includes the device design but its radiological/fluoroscopic appearance and how it correlates with the implanted valve, as transcatheter aortic valve implantation is performed under fluoroscopic guidance. Here we illustrate the fluoroscopic appearance of 11 commercially available surgical bioprostheses and two commercially available transcatheter heart valves and discuss important aspects in their design which can influence outcome of a valve-in-valve procedure. We have also collated relevant information on the aspects of the design of a bioprosthetic valve, which are relevant to the valve-in-valve procedure.
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