Abstract:Background-The Early Self Controlled Anticoagulation Trial (ESCAT I) showed that anticoagulation self-management after mechanical heart valve replacement decreased complication rates by maintaining INR levels closer to the target range than International Normalized Ratio (INR) home doctor management. The therapeutic range for the INR in that study was between 2.5 and 4.5 for all positions of prosthetic valves. ESCAT II should find out whether lowering the target range for INR self-management would further redu… Show more
“…11,12 The German-Dutch Ross Registry is a prospective multicenter cohort study with 1742 patients. Started in February 1991, the registry includes data from 12 cardiothoracic surgery departments in the Netherlands and Germany [7][8][9][10] (see the online-only Data Supplement for a list of participating centers).…”
Background-It is suggested that in young adults the Ross procedure results in better late patient survival compared with mechanical prosthesis implantation. We performed a propensity score-matched study that assessed late survival in young adult patients after a Ross procedure versus that after mechanical aortic valve replacement with optimal self-management anticoagulation therapy. Methods and Results-We selected 918 Ross patients and 406 mechanical valve patients 18 to 60 years of age without dissection, aneurysm, or mitral valve replacement who survived an elective procedure (1994 to 2008). With the use of propensity score matching, late survival was compared between the 2 groups. Two hundred fifty-three patients with a mechanical valve (mean follow-up, 6.3 years) could be propensity matched to a Ross patient (mean follow-up, 5.1 years). Mean age of the matched cohort was 47.3 years in the Ross procedure group and 48.0 years in the mechanical valve group (Pϭ0.17); the ratio of male to female patients was 3.2 in the Ross procedure group and 2.7 in the mechanical valve group (Pϭ0.46). Linearized all-cause mortality rate was 0.53% per patient-year in the Ross procedure group compared with 0.30% per patient-year in the mechanical valve group (matched hazard ratio, 1.86; 95% confidence interval, 0.58 to 5.91; Pϭ0.32). Late survival was comparable to that of the general German population. Conclusions-In comparable patients, there is no late survival difference in the first postoperative decade between the Ross procedure and mechanical aortic valve implantation with optimal anticoagulation self-management. Survival in these selected young adult patients closely resembles that of the general population, possibly as a result of highly specialized anticoagulation self-management, better timing of surgery, and improved patient selection in recent years. (Circulation. 2011;123:31-38.)
“…11,12 The German-Dutch Ross Registry is a prospective multicenter cohort study with 1742 patients. Started in February 1991, the registry includes data from 12 cardiothoracic surgery departments in the Netherlands and Germany [7][8][9][10] (see the online-only Data Supplement for a list of participating centers).…”
Background-It is suggested that in young adults the Ross procedure results in better late patient survival compared with mechanical prosthesis implantation. We performed a propensity score-matched study that assessed late survival in young adult patients after a Ross procedure versus that after mechanical aortic valve replacement with optimal self-management anticoagulation therapy. Methods and Results-We selected 918 Ross patients and 406 mechanical valve patients 18 to 60 years of age without dissection, aneurysm, or mitral valve replacement who survived an elective procedure (1994 to 2008). With the use of propensity score matching, late survival was compared between the 2 groups. Two hundred fifty-three patients with a mechanical valve (mean follow-up, 6.3 years) could be propensity matched to a Ross patient (mean follow-up, 5.1 years). Mean age of the matched cohort was 47.3 years in the Ross procedure group and 48.0 years in the mechanical valve group (Pϭ0.17); the ratio of male to female patients was 3.2 in the Ross procedure group and 2.7 in the mechanical valve group (Pϭ0.46). Linearized all-cause mortality rate was 0.53% per patient-year in the Ross procedure group compared with 0.30% per patient-year in the mechanical valve group (matched hazard ratio, 1.86; 95% confidence interval, 0.58 to 5.91; Pϭ0.32). Late survival was comparable to that of the general German population. Conclusions-In comparable patients, there is no late survival difference in the first postoperative decade between the Ross procedure and mechanical aortic valve implantation with optimal anticoagulation self-management. Survival in these selected young adult patients closely resembles that of the general population, possibly as a result of highly specialized anticoagulation self-management, better timing of surgery, and improved patient selection in recent years. (Circulation. 2011;123:31-38.)
“…A secondary end point was bleeding complications. TEs and bleeding were defined in accordance with previous reports 6,27,28 and current guidelines, 26 along with a neurologic consultation to assess strokes. Bleeding within 48 h of cardiopulmonary bypass was not taken into account.…”
Section: Follow-up and Eventsmentioning
confidence: 99%
“…Because high-intensity anticoagulation is associated with high variability, lower INR goals (possibly 2 to 3) would reduce variability. Also, higher testing frequency improves the length of time spent in the target range 33,[37][38][39] and is an incentive for anticoagulation clinics or INR selfmanagement 21,27,38 as tools to improve anticoagulation effectiveness.…”
Background: Thromboembolic events (TEs) are frequent after mechanical mitral valve replacement (MVR), but their association to anticoagulation quality is unclear and has never been studied in a population-based setting with patients who have a complete anticoagulation record. Conclusion: This population-based comprehensive study of anticoagulation and TE post-MVR shows that, in these closely anticoagulated patients, anticoagulation intensity was highly variable and not associated with TE incidence post-MVR. Higher anticoagulation intensity is linked to higher variability and, thus, to bleeding. The MVR-ball prosthesis design is associated with higher TE rates notwithstanding higher anticoagulation intensity, and its use should be retired worldwide.(CHEST 2009; 136:1503-1513)
“…11 Each test was followed by a telephone consult from the physician directly to the patient. For selfmanagement, we assumed that patients conducted weekly INR tests and contacted a pharmacist after each test during the first month and once a month thereafter.…”
Section: Model Inputsmentioning
confidence: 99%
“…[4][5][6][7][8][9][10][11][12][13] It has been found that patients who self-manage check their INR more frequently and are able to maintain a greater proportion of INRs within the therapeutic range compared with those whose therapy is monitored by a physician or in an anticoagulation clinic. [11][12][13] The results of a recent meta-analysis showed a significant reduction in thromboembolic events (odds ratio [OR] 0.45), major hemorrhagic events (OR 0.65) and all-cause mortality (OR 0.61) for those using a self-management or self-test strategy. 14 The results also showed that self-management compared with self-testing alone reduces the occurrence of thromboembolic events (OR 0.27) and death (OR 0.37).…”
ResearchL ong-term oral anticoagulation therapy with vitamin K antagonists is prescribed as prophylaxis against strokes and other embolic events in patients with atrial fibrillation or a mechanical heart valve. 1,2 Warfarin therapy, however, is complicated by the variability of its biologic effect, its narrow therapeutic index, and the associated thrombotic or hemorrhagic events in the event of over-or underanticoagulation. 2 It has been shown that improved anticoagulant control can be achieved through frequent monitoring of the international normalized ratio (INR), resulting in improved health outcomes. 3 Monitoring the INR and managing warfarin dosing by a primary care physician is the current clinical standard of practice in Canada. 4 Physician management requires patients to visit a laboratory regularly for INR testing. The laboratory reports the INR to the physician, who subsequently contacts the patient with any required change in dosage. An alternative strategy is patient self-management. Self-management entails the measurement of the INR by the patient using a pointof-care device and, when necessary, self-adjustment of the warfarin dose using a nomogram. 4 Several published trials have compared self-management with physician management or management in an anticoagulation clinic. 4-13 It has been found that patients who self-manage check their INR more frequently and are able to maintain a greater proportion of INRs within the therapeutic range compared with those whose therapy is monitored by a physician or in an anticoagulation clinic. [11][12][13] The results of a recent meta-analysis showed a significant reduction in thromboembolic events (odds ratio [OR] 0.45), major hemorrhagic events (OR 0.65) and all-cause mortality (OR 0.61) for those using a self-management or self-test strategy. 14 The results also showed that self-management compared with self-testing alone reduces the occurrence of thromboembolic events (OR 0.27) and death (OR 0.37). 14 These results, together with the greater initial costs of educating patients to self-manage and of the pointof-care device itself, provide the impetus for a formal costeffectiveness analysis.The objective of this study was to evaluate the incremental cost and health benefits of self-managed versus physicianmanaged chronic oral anticoagulation therapy from the perspective of the Canadian health care payer. A Bayesian approach was adopted to facilitate the incorporation of prior knowledge of transition probabilities and for probabilistic sensitivity analysis. Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy Background: Patient self-management of long-term oral anticoagulation therapy is an effective strategy in a number of clinical situations, but it is currently not a funded option in the Canadian health care system. We sought to compare the incremental cost and health benefits of self-management with those of physician management from the perspective of the Canadian health care payer over a 5-year period.
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