Predicting Quality of Life at 1 Year After Transcatheter Aortic Valve Replacement in a Real-World Population.

Background Among clinical trial patients at high surgical risk, a model has been developed and externally validated to estimate patient risk for poor outcomes after transcatheter aortic valve replacement (TAVR). How this model performs in lower risk and unselected patients is not known. We sought to examine and optimize the performance of the TAVR poor outcome risk model among patients in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Methods and Results Among 13 351 patients who underwent TAVR at 252 US sites between November 9, 2011 and June 30, 2015, the rate of poor outcome at 1 year after TAVR was 38.9%, which was because of death in 20.7% and poor quality of life or quality of life decline in 18.2%. The rate of poor outcome has decreased slightly over time, from 42.0% in 2012 to 37.8% in 2015 ( P for trend=0.076). The original TAVR poor outcome risk model did not calibrate well on this population. We then reestimated the intercept and coefficients in the model and retested model performance, after which it performed well (both overall and in subgroups), with a C index 0.65 and excellent calibration. Conclusions In a large cohort of unselected patients in the United States, we found that while a substantial minority of patients continue to have a poor outcome after TAVR, outcomes have slowly improved over time. After recalibration, the TAVR poor outcome risk model performed well. This model could potentially be used before TAVR to help patients have appropriate expectations of recovery.

Transcatheter Versus Surgical Aortic Valve Replacement: Propensity-Matched Comparison.

BACKGROUND: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. OBJECTIVES: The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort. METHODS: Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities. RESULTS: In a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients. CONCLUSIONS: Among unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.

[Retrospective studies on the relation between fibrocystic disease and cancer of the breast with therapeutic conclusions]. / Cercetari retrospective asupra raportului dintre boala fibrochistica si cancerul de sîn, cu concluzii terapeutice.

On the basis of 597 cases of benign and malignant tumoral, respectively dysplastic diseases of the breast, operated at the IInd Surgical Clinic of Tirgu-Mures during the period 1977-1983, the authors consider the fibrocystic disease (FCD) of the II and III degree as a facultative precancerous lesion. The extremely high frequency of FCD associated to the mammary cancer in young women, as well as of intense epithelial proliferations and intermediate forms, of transition from typical epithelial hyperplasias to the atypical forms observed in some of these cases, is pointed out. The 4 cases (1.94%) of mammary neoplasms which occurred late after a mammary sectorectomy performed for FCD illustrate that the risk of mammary neoplasm in FCD is 7.4 times higher than the mammary cancer rate in women without FCD. In the extensive forms of FCD with marked epithelial proliferations, especially if additional risk factors are also present, the authors recommend a uni- or bilateral subcutaneous mastectomy, a uni- or bilateral simple mastectomy respectively. They deem necessary the setting up, in all departments of general surgery, of an adequate organizational framework for the dispensary care, the hormonal therapy and the control of women with FCD.

[5-fluorouracil treatment of acute pancreatitis and of pancreatic and duodenal fistulae]. / Tratamentul cu 5-fluorouracil al pancreatitelor acute si al fistulelor pancreatice si duodenale.

In acute pancreatitis the mechanism involved in the auto-amplification of morbid phenomena can be suppressed in most of the cases by inhibiting the pancreatic secretion. This can also enhance the repair of pancreatic, duodenal and jejunal fistulae. On the basis of experimental studies carried out by Johnson, and on the clinical studies of Guttmann, as well as on original studies done by the authors, Ftorafur was included in the complex therapy of acute pancreatitis, and of pancreatic and duodenal fistulae. A group of 14 cases of acute pancreatitis, were treated. These included 5 necrotic-haemorrhagic pancreatitis, and 9 oedematous pancreatitis. The drug was given by continuous intravenous perfusion in doses of 1,200-1,600 mg per day, for a period of 6-12 days. In all the cases the clinical improvement of the patients as well as recovery of normal values of blood amylase were spectacular, and full recovery was achieved in all the cases. Ftorafur was also used in 3 cases of pancreatic fistulae, and in 2 cases of duodenal fistulae, and recovery was also achieved in a very short time. On the basis of this experience, although small, the authors recommend the introduction of Ftorafur in the complex therapy of acute pancreatitis, as well as in that of pancreatic and duodenal fistulae. Following administration of Ftorafur no adverse effects were noted, and in the doses mentioned above this drug did not delay the repair of surgical wounds.

[An experimental study of the action of 5-fluorouracil on the function and cytomorphology of the exocrine pancreas]. / Studiu experimental privind actiunea 5-fluorouracilului asupra functiei si citomorfologiei pancreasului exocrin.

The authors have taken up previous studies by Martin (1969), and by Johnson (1973), and carried out an experimental study on white rats aimed at evaluating the morpho-functional changes of cells from the exocrine pancreas under the influence of 5-fluorouracil (Ftorafur), a cytostatic drug which is a general inhibitor of protein synthesis by cells. Ftorafur was injected in amounts of 2.3 mg/100 g of body weight, and a significant reduction was noted in the secretion of bicarbonates, amylase and lipase by the pancreas of the animals. Cytologic changes were also noted in the pancreatic tissue of these animals, indicating, on the one hand, a deficient protein and enzyme synthesis by the pancreatic cells, and a blocking of the mechanism of discharge of zymogen granules, on the other hand. The most intensive morpho-functional changes were noted following repeated administration of Ftorafur, probably due to the cumulative effects of this substance at the level of secretory pancreatic cells. The authors consider that 5-fluorouracil inhibits to a considerable degree the synthesis of pancreatic enzymes, and as such it can be used as a therapeutic means for the reduction of the external secretion of the pancreas.

[Prevention of postsurgical thromboembolism with small doses of heparin]. / Profilaxia bolii tromboembolice postoperatorii cu doze mici de heparina.

The study includes 390 patients of different age, operated for various conditions during the last quarter of 1975, and systematically treated post operatively with heparin (the cases in which heparin was contraindicated were not included). None of the patients developed signs of thromboembolism after the operation. The drawbacks of the method are virtually inexistent as compared to the gravity of postoperative thrombolic complications. A further study included 1708 operated patients of whom 223 (13.0%) received the heparin treatment and 1485 (87.0%) did not. There was no thrombolic-embolic complication in the former lot and 12 cases (0.8%) in the latter. Three of 15 patients (20%) in whom the postoperative heparin treatment was interrupted immediately or very soon, developed thromboembolism. The method is efficient provided it is applied after the operation up to complete mobilization of the patient. The method is readily applicable, there is no risk and haemostasis is insured.