Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage

BACKGROUND: Left atrial appendage occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Evaluating real-life clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology was designed to collect prospective multicenter outcomes of thromboembolic events, bleeding, and mortality for patients implanted with a WATCHMAN in routine daily practice. METHODS: One thousand twenty patients with a WATCHMAN implant procedure were prospectively followed in 47 centers. Left atrial appendage occlusion indication was based on the European Society of Cardiology guidelines. Follow-up and imaging were performed per local practice up to a median follow-up of 2 years. RESULTS: Included population was old (age 73.4±8.9 years), at high risk for stroke (311 prior ischemic stroke/transient ischemic attack and 153 prior hemorrhagic stroke) and bleeding (318 prior major bleeding), with CHA2 DS2 -VASc score ≥5 in 49%, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, Labile international normalized ratio, elderly, drugs/alcohol concomitantly ≥3 in 40% and oral anticoagulation contraindication in 72%. During follow-up, 161 patients (16.4%) died, 22 strokes were observed (1.3/100 patient-years, 83% reduction versus historic data), and 47 major nonprocedural bleeding events (2.7/100 patient-years, 46% reduction versus historic data). Stroke and bleeding rates were consistently lower than historic data in those with prior ischemic (−76% and −41%) or hemorrhagic (−81% and 67%) stroke and prior bleeding (−85% and −30%). Lowest bleeding rates were seen in patients with early discontinuation of dual antiplatelet therapy. Patients with early discontinuation of antithrombotic therapy showed lower bleeding rates, while they were highest for those with prior bleeding. Device thrombus was observed in 34 patients (4.1%) and was not correlated to drug regimen during follow-up (P=0.28). CONCLUSIONS: During the complete 2-year follow-up of Evaluating RealLife Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology, patients with a WATCHMAN left atrial appendage occlusion device had consistently low rates of stroke and nonprocedural bleeding, although most were contraindicated to oral anticoagulation and used only single antiplatelet therapy or nothing

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II–III and BIOFLOW II trials

Background: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. Methods: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. Results: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ± 10.8 and 62.7 ± 10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. Conclusion: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion

Role of testosterone in cognition and mobility of aging men

Background Cognitive decline and impairment of physical performance and mobility are age-related clinical problems with major negative impact on quality of life of elderly men. In how far the decline of testosterone production contributes to these problems in older men and whether testosterone therapy can contribute to slow down, prevent, or reverse their development remains subjects of debate. Objectives This narrative review presents the current knowledge on association of sex steroid status with cognitive decline and impairment of physical function and mobility in elderly men and on the effects of testosterone therapy on cognition and on physical performance and mobility in elderly men. Materials and Method The review is based on electronic database searches with primary focus on evidence from larger prospective observational studies and from controlled randomized trials, respectively. Results In most observational studies, testosterone levels do not predict cognitive decline or development of Alzheimer's disease. In randomized trials, testosterone therapy did not significantly affect cognition in men with low or low-to-normal serum testosterone, regardless of whether they have preexisting cognitive impairment. Overall, observational data indicate that the usually moderate decline of androgen exposure in older men cannot fully account for the parallel decline of physical performance and mobility. Trials of testosterone therapy in older men with low or low-normal serum testosterone, whether they were generally healthy or suffered from physical function impairments, either did not show any effect on mobility and physical performance or showed limited effects of uncertain clinical relevancy. Discussion and Conclusions The whole of the evidence tends to downplay the role of sex steroid status in the decline of cognitive function and impairment of physical function and mobility in older men. Based on the available evidence, prevention or treatment of cognitive decline or of impairment of mobility and physical function are not valid indications for testosterone treatment in older men with low or low-to-normal serum testosterone levels

Thoracic endovascular aneurysm repair for complicated type B aortic dissection.

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A Rare Clinical Course of Seronegative Pulmonary-Renal Syndrome

Purpose. Pulmonary-renal syndrome (PRS) is characterized by diffuse alveolar hemorrhage and rapidly progressive glomerulonephritis mainly due to autoimmune etiologies. Seronegative PRS is a challenging entity to the clinician, since early diagnosis may be missed leading to delayed appropriate treatment. Materials and Methods. We present the clinical course of a 77-year-old patient who was admitted under the suspected diagnosis of pneumogenic sepsis and septic renal failure with fever, dyspnea, and elevated CRP levels. The diagnosis of pulmonary-renal syndrome was initially missed because of the absence of autoantibodies in all serological findings. Results. Despite delayed initiation of immunosuppressive therapy and a prolonged period of dialysis and extracorporeal membrane oxygenation the patient recovered well and was released to a rehabilitation center with nearly normalized creatinine levels. The diagnosis of PRS was established by renal biopsy. Conclusion. This case illustrates the important differential diagnosis of seronegative pulmonary-renal syndrome in patients with pulmonary and renal impairment

Survival after endovascular therapy in patients with type B aortic dissection: a report from the International Registry of Acute Aortic Dissection (IRAD).

Abstract OBJECTIVES: This study sought to evaluate long-term survival in type B aortic dissection patients treated with thoracic endovascular aortic repair (TEVAR) therapy. BACKGROUND: Historical data have supported medical therapy in type B acute aortic dissection (TBAAD) patients. Recent advances in TEVAR appear to improve in-hospital mortality. METHODS: We examined 1,129 consecutive patients with TBAAD enrolled in IRAD (International Registry of Acute Aortic Dissection) between 1995 and 2012 who received medical (n = 853, 75.6%) or TEVAR (n = 276, 24.4%) therapy. RESULTS: Clinical history was similar between groups. TEVAR patients were more likely to present with a pulse deficit (28.3% vs. 13.4%, p < 0.001) and lower extremity ischemia (16.8% vs. 3.6%, p < 0.001), and to characterize their pain as the "worst pain ever" (27.5% vs. 15.7%, p < 0.001). TEVAR patients were also most likely to present with complicated acute aortic dissection, defined as shock, periaortic hematoma, signs of malperfusion, stroke, spinal cord ischemia, mesenteric ischemia, and/or renal failure (61.7% vs. 37.2%). In-hospital mortality was similar in patients managed with endovascular repair (10.9% vs. 8.7%, p = 0.273) compared with medically managed patients. One-year mortality was also similar in both groups (8.1% endovascular vs. 9.8% medical, p = 0.604). Among adverse events during follow-up, aortic growth/new aneurysm was most common, occurring in 73.3% of patients with medical therapy and in 62.7% of patients after TEVAR, based on 5-year Kaplan-Meier estimates. Kaplan-Meier survival estimates showed that patients undergoing TEVAR had a lower death rate (15.5% vs. 29.0%, p = 0.018) at 5 years. CONCLUSIONS: Results from IRAD show that TEVAR is associated with lower mortality over a 5-year period than medical therapy for TBAAD. Further randomized trials with long-term follow-up are needed