Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P <.001) in the low-dose and standard-dose warfarin groups, respectively. Primary end point rates were 11.9% per patient-year in the low-dose group and 12.0% per patient-year in the standard-dose group (difference, -0.07%; 95% CI, -3.40% to 3.26%). The CI >1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525).

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

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Review of efforts to decrease costly leg wound complications in the medicare population following coronary revascularization.

BACKGROUND: Current trends show that patients referred for coronary artery bypass grafting (CABG) are significantly older, sicker, and at higher risk for complications than ever before. Eliminating leg wound complications would significantly benefit these patients and reduce the consumption of health care time and dollars. Endoscopic vein harvesting (EVH) decreases the risk of wound complications in patients following CABG and may decrease costly long-term wound-related problems. METHODS: In this retrospective study, the cases of 1909 Medicare patients who had undergone EVH or open vein harvesting (OVH) for CABG were reviewed. The risk factors of these patients were examined and compared with those of 1485 non- Medicare patients. Readmissions, home health care costs, and office lengths of service were reviewed and analyzed. RESULTS: The results of univariate analyses of the Medicare versus non-Medicare populations indicated significant differences for peripheral vascular disease (25.4% versus 17.2%; P <.0001), renal failure (6.0% versus 2.8%; P <.0001), hypertension (75.4% versus 71.5%; P =.011), female sex (31.1% versus 22.4%; P <.0001), mean age (69.8 years versus 57.1 years; P <.0001), and mortality risk (4.6% versus 2.2%; P <.0001). The wound rates in the Medicare group were 1.1% for EVH (n = 741) versus 2.8% for OVH (n = 1168), and this difference was significant (P =.0163) despite a higher frequency of morbid obesity in the EVH population (P <.0001). No significant differences were found in readmission frequency, home health care costs, or office length of service. CONCLUSION: EVH benefits Medicare patients. Although this study is the largest to date to use disposable instruments, there is a lack of statistical power in the analysis of cost comparisons due to the small sample size of wound complications. However, there appears to be a general trend toward a lower treatment cost per patient and less resource use with EVH.

Endoscopic vein harvest of the lesser saphenous vein in the supine position: a unique approach to an old problem.

OBJECTIVES: To obtain a suitable conduit from the lesser (short) saphenous system for use in coronary artery bypass surgery. We wanted to perform this while the patient was in the supine position as to not disrupt the standard operation, and at the same time, utilizing the endoscopic vein harvest technique with its obvious abilities to decrease vein harvest morbidity. We also theorized that through endoscopic techniques instead of the open technique we could harvest greater lengths of conduit, thus providing quality vein segments for additional grafts if needed. METHODS: We were able to perform endoscopic vein harvest while in the supine position with one unique centrally located incision that has not been previously described. RESULTS: The lesser saphenous vein harvested in the described technique provided excellent conduit for our patients that were conduit poor. The endoscopic technique allowed increased length of harvested segments, by giving us the ability to travel under the gastrocnemius muscle with minimal morbidity as opposed to the open technique, where the traditional endpoint is the aforementioned muscle. Conduits were harvested successfully from 14 of 16 candidates. No wound infections or healing problems were experienced. Neurovascular integrity was maintained in all patients. CONCLUSIONS: Endoscopic vein harvest of the lesser saphenous vein with the patient in the supine position is safe, effective and affords conduits for a unique subset of patients undergoing coronary artery bypass grafting.