Ernst Eigenbauer

Long-term results of heart valve replacement with the Edwards Duromedics bileaflet prosthesis: A prospective ten-year clinical follow-up

OBJECTIVE The Edwards Duromedics valve (Baxter Healthcare Corp., Edwards Division, Santa Ana, Calif.) was designed with a self-irrigating hinge mechanism to reduce thromboembolic complications. After good initial clinical results, distribution was suspended in 1988 after reports of valve fracture after 20,000 valves had been implanted. The manufacturer conducted extensive studies to improve the Edwards Duromedics and reintroduced a modified version, which is available as Edwards Tekna. The purpose of the study was the evaluation of long-term results of the original Edwards Duromedics that might be important for the current version, the Edwards Tekna valve. METHODS A prospective clinical 10-year follow-up was performed of 508 patients who underwent valve replacement with the Edwards Duromedics valve in the aortic (n = 268), mitral (n = 183), and aortic and mitral (n = 56) position. RESULTS The perioperative mortality rate was 6.9%; follow-up was 98% complete, comprising 3648 patient-years for a mean follow-up of 86 months (range: 33 to 144 months). The actuarial freedom from complications at the 10-year follow-up and the incidence rate (percent per patient-year) were as follows: late mortality rate, 69.2% +/- 2.4% (3.5% per patient-year); thromboembolism, 90.7% +/- 1.6% (0.96% per patient-year); anticoagulation-related hemorrhage, 87.7% +/- 1.7% (1.34% per patient-year); prosthetic valve endocarditis, 96.7% +/- 0.09% (0.38% per patient-year); valve-related mortality rate, 89.3% +/- 1.6% (1.21% per patient-year); valve failure, 86.2% +/- 1.85% (1.54% per patient-year); and valve-related morbidity and mortality rate, 71.1% +/- 2.3% (3.2% per patient-year). Three leaflet escapes were observed (one lethal, two successful reoperations; 99.1% +/- 0.05% freedom, 0.08% per patient-year). All patients functionally improved (86% in New York Heart Association classes I and II), and incidence of anemia was insignificant. CONCLUSIONS These results confirm that the Edwards Duromedics valve shows excellent performance concerning thromboembolism, hemolysis, and functional improvement and will serve as a reference for the last version, the Edwards Tekna valve, where comparable long-term data are currently not available.

Red Cell Distribution Width and Other Red Blood Cell Parameters in Patients with Cancer: Association with Risk of Venous Thromboembolism and Mortality

Background Cancer patients are at high risk of developing venous thromboembolism (VTE). Red cell distribution width (RDW) has been reported to be associated with arterial and venous thrombosis and mortality in several diseases. Here, we analyzed the association between RDW and other red blood cell (RBC) parameters with risk of VTE and mortality in patients with cancer. Methods RBC parameters were measured in 1840 patients with cancers of the brain, breast, lung, stomach, colon, pancreas, prostate, kidney; lymphoma, multiple myeloma and other tumor sites, that were included in the Vienna Cancer and Thrombosis Study (CATS), which is an ongoing prospective, observational cohort study of patients with newly diagnosed or progressive cancer after remission. Primary study outcome is occurrence of symptomatic VTE and secondary outcome is death during a maximum follow-up of 2 years. Results During a median follow-up of 706 days, 131 (7.1%) patients developed VTE and 702 (38.2%) died. High RDW (>16%) was not associated with a higher risk of VTE in the total study cohort; in competing risk analysis accounting for death as competing variable the univariable subhazard ratio (SHR) was 1.34 (95% confidence interval [CI]: 0.80–2.23, p = 0.269). There was also no significant association between other RBC parameters and risk of VTE. High RDW was associated with an increased risk of mortality in the total study population (hazard ratio [HR, 95% CI]: 1.72 [1.39–2.12], p<0.001), and this association prevailed after adjustment for age, sex, hemoglobin, leukocyte and platelet count (HR [95% CI]: 1.34 [1.06–1.70], p = 0.016). Conclusions RDW and other RBC parameters were not independently associated with risk of VTE in patients with cancer and might therefore not be of added value for estimating risk of VTE in patients with cancer. We could confirm that high RDW is an independent predictor of poor overall survival in cancer.

The influence of thrombophilia on the long-term survival of patients with a history of venous thromboembolism

Data on the long-term survival following venous thromboembolism (VTE) are rare, and the influence of thrombophilia has not been evaluated thus far. Our aim was to assess thrombophilia-parameters as predictors for long-term survival of patients with VTE. Overall, 1,905 out-patients (99 with antithrombin-, protein C or protein S deficiency, 517 with factor V Leiden, 381 with elevated factor VIII and 160 with elevated homocysteine levels, of these 202 had a combination and 961 had none of these risk factors) were included in the study between September 1, 1994 and December 31, 2007. Retrospective survival analysis showed that a total of 78 patients (4.1%) had died during the analysis period, among those four of definite or possible pulmonary embolism and four of bleeding. In multivariable analysis including age and sex an association with increased mortality was found for hyperhomocysteinemia (hazard ratio 2.0 [1.1.-3.5]) whereas this was not the case for all other investigated parameters. We conclude that the classical hereditary thrombophilia risk factors did not have an impact on the long-term survival of patients with a history of VTE. Thus our study supports the current concept that thrombophilia should not be a determinant for decision on long term anticoagulation. However, hyperhomocysteinaemia, known as a risk factor for recurrent VTE and arterial disease, might impact survival.

Endoscopic vein harvesting is influenced by patient-related risk factors and may be of specific benefit in female patients

OBJECTIVES The standard of care regarding endoscopic vein harvesting (EVH) is still inhomogeneous across Europe. The current study aimed at elucidating patient-related factors favouring its application and procedure-related outcome in a tertiary care centre. METHODS All patients who underwent coronary artery bypass grafting with or without concomitant valve procedures between 2008 and 2011 were included. Emergency surgery and all arterial revascularization patients were excluded. RESULTS A total of 262 endoscopically harvested patients and 623 open vein harvested patients were included. Mortality, perfusion time and cross-clamp time were not significantly different. Peripheral artery disease predisposed open vein harvesting (odds ratio [OR] 1.9; P = 0.001); diabetes and a higher number of diseased coronary vessels favoured EVH (OR 0.6; P = 0.003 and 0.002). Further, the number of bypass grafts was significantly increased in the endoscopic group, but these patients required less periprocedural blood transfusions (1.4 ± 1.8 vs 1.8 ± 3.0; P = 0.035). Minor wound healing complications were more common in the open group (10.3 vs 3.8%; P = 0.001). Severe complications in the leg requiring surgical revision occured in 2.4% of open vein harvested patients compared with 1.1% for endoscopic patients (P = ns). After a multivariate regression analysis, only female gender remained as a significant risk factor for impaired wound healing (OR 2.4; P = 0.001), whereas EVH reduced the risk of wound-healing complications (OR 0.4; P = 0.008). CONCLUSIONS EVH dramatically reduced postoperative would healing complications. Women were more likely to develop mild and severe leg wound complications. Therefore, women may benefit even more from EVH. In general, the favourable outcomes of EVH should result in a more widespread use of this technology in men and women.

High proportion of patients with bleeding of unknown cause in persons with a mild-to-moderate bleeding tendency: Results from the Vienna Bleeding Biobank (VIBB)

Data on clinical characteristics and the prevalence of underlying coagulopathies in patients with mild‐to‐moderate bleeding disorders (MBDs) are scarce.