Risk factors for vertebral fractures and bone loss after denosumab discontinuation: A real-world observational study.

BACKGROUND: Denosumab discontinuation without subsequent bisphosphonates (BPs) is associated with bone loss and multiple vertebral fractures. OBJECTIVE: Identifying risk factors for bone loss and vertebral fractures after denosumab discontinuation. METHODS: This retrospective study measured the outcome of 219 women with osteoporosis who discontinued denosumab treatment and received subsequent treatment with zoledronate, other BPs or a selective estrogen receptor modulator (SERM), or no therapy. Fracture rate, longitudinal bone mineral density (BMD) changes and bone turnover markers (BTMs) within 2 years after denosumab discontinuation were analysed. Linear regression analysis evaluated loss of BMD and age, BMI (kg/m2), denosumab treatment duration, pre-treatment, prior fracture state, baseline T-scores, use of glucocorticoids or aromatase inhibitors and BMD gains under denosumab therapy. RESULTS: 171 women received zoledronate after denosumab discontinuation, 26 had no subsequent treatment and 22 received other therapies (other BPs or a SERM). Zoledronate was associated with the fewest vertebral fractures (hazard ratio 0.16, p = 0.02) and all subsequent therapies retained BMD at all sites to some extent. Higher BMD loss was associated with younger age, lower BMI, longer denosumab treatment, lack of prior antiresorptive treatment and BMD gain under denosumab treatment. BTM levels correlated with denosumab treatment duration and bone loss at the total hip, but not the lumbar spine. CONCLUSIONS: Compared to no subsequent therapy, zoledronate was associated with fewer vertebral fractures after denosumab. Further, BMD loss depended on denosumab treatment duration, age, prior BP therapy and BMD gain under denosumab therapy, whereas BTM levels were associated with bone loss at the total hip and denosumab treatment duration.

Aorta Related and All-cause Mortality in Patients with Aortic Intramural Haematoma.

OBJECTIVES: The prognosis of patients with intramural haematoma (IMH) of the aorta beyond the first year after diagnosis remains largely unknown. In particular, patients that do not undergo interventions are lost to follow-up. The aim was to assess medium-term outcome in IMH patients. METHODS: Post hoc analysis of 63 consecutive patients presenting with IMH between 1999 and 2013 was performed. Patients meeting imaging criteria at the first presentation were included even if follow-up imaging showed evidence of intimal disruption or false lumen flow. RESULTS: Eighteen patients presented with type A and 45 with type B IMH (29% vs. 71%, p < .001). The mean age was 71 ± 9.2 years, range 42-88 years. Follow-up was completed in 97% of patients by May 2017 and represents a mean follow-up of 6.3 ± 3.6 years. Freedom from intervention in patients with type B IMH was 40%. TEVAR was performed in 47% because of development, unmasking of an entry tear (57%), progression to acute type B dissection (24%), or subsequent dilation of the affected aortic segments (19%). Open repair was performed in 13% of type B IMH patients because of dilation of the descending aorta. In type A IMH, 89% underwent open repair. Aorta related 30 day, 6 month, 1 year, and late mortality were 1.6%, 6.3%, 6.3%, and 9.5%, respectively, for all IMH patients. All-cause 30 day, 6 month, 1 year, and late mortality were 1.6%, 6.3%, 6.3%, and 47.6%, respectively, for all IMH patients. Late mortality in type B IMH did not differ whether patients underwent TEVAR, open repair, or received best medical treatment only (26% vs. 22%, p = 1.0). CONCLUSIONS: Late aorta related mortality in IMH was low whereas all-cause mortality was substantial. Aorta related mortality in IMH patients only occurs during the first year after diagnosis. Interventions after the first year are rarely necessary.

Editor's Choice - Incidence of Stroke Following Thoracic Endovascular Aortic Repair for Descending Aortic Aneurysm: A Systematic Review of the Literature with Meta-analysis.

OBJECTIVE: Stroke is an increasingly recognised complication following thoracic endovascular aortic repair (TEVAR). The aim of this study was to systematically synthesise the published data on perioperative stroke incidence during TEVAR for patients with descending thoracic aneurysmal disease and to assess the impact of left subclavian artery (LSA) coverage on stroke incidence. METHODS: A systematic review of English and German articles on perioperative (in-hospital or 30 day) stroke incidence following TEVAR for descending aortic aneurysm was performed, including studies with ≥50 cases, using MEDLINE and EMBASE (2005-2015). The pooled prevalence of perioperative stroke with 95% CI was estimated using random effect analysis. Heterogeneity was examined using I2 statistic. RESULTS: Of 215 studies identified, 10 were considered suitable for inclusion. The included studies enrolled a total of 2594 persons (61% male) between 1997 and 2014 with a mean weighted age of 71.8 (95% CI 71.1-73.6) years. The pooled prevalence for stroke was 4.1% (95% CI 2.9-5.5) with moderate heterogeneity between studies (I2 = 49.8%, p = .04). Five studies reported stroke incidences stratified by the management of the LSA, that is uncovered versus covered and revascularised versus covered and not-revascularised. In cases where the LSA remained uncovered, the pooled stroke incidence was 3.2% (95% CI 1.0-6.5). There was, however, an indication that stroke incidence increased following LSA coverage, to 5.3% (95% CI 2.6-8.6) in those with a revascularisation and 8.0% (95% CI 4.1-12.9) in those without revascularisation. CONCLUSION: Stroke incidence is an important morbidity after TEVAR, and probably increases if the LSA is covered during the procedure, particularly in those without revascularisation.

Best medical therapy or wishful thinking in carotid disease? A single-centre audit in Germany.

INTRODUCTION: The optimal treatment of asymptomatic carotid disease is being debated again. The conclusions of the large randomised controlled trials of the early 1980s and 1990s are increasingly being questioned due to advances in modern medical treatment. This study investigates how patients are actually managed medically related to general risk factors prior to carotid endarterectomy in a German health-care region. MATERIALS/METHODS: A prospective data bank including 95 consecutive patients was used. The effectiveness of lipid lowering and diabetes management were investigated as well as the use of anti-thrombotic and blood pressure medication. RESULTS: A total of 108 carotid endarterectomies in 95 patients were performed between January 2009 and March 2010. All 95 patients (70 male, 25 female; 39 symptomatic/56 asymptomatic) were included in the study. Nearly half (54%) of the patients were on statins; of these, 45% had low-density lipoprotein (LDL) levels >100 mg dl(-1). Of 32 patients with diabetes, one had glycohaemoglobin (HbA(1c)) <6.0. Overall, four patients were on clopidogrel. Three patients were severely hypertensive (systolic blood pressure >180 mmHg). CONCLUSIONS: The best medical therapy for carotid disease is not optimal in the part of the German health-care system observed in this study. We strongly advocate similar audits in other health-care areas and systems.

Mini ECC vs. conventional ECC: an examination of venous oxygen saturation, haemoglobin, haematocrit, flow, cardiac index and oxygen delivery.

In our clinical daily routine, it is noticeable that lower cardiac indices are reached more often without negative consequences when using mini extracorporeal circulation (ECC) systems than when using open ECC systems. We evaluated haemoglobin concentration, haematocrit, blood flow, cardiac index (CI) and mixed-venous oxygen saturation (vSO2) in patients undergoing surgery using mini ECC (n=10 cases) and ECC (n=10 cases). This analysis shows that, with a mini ECC system, the range of oxygen delivery is equal to that achieved when using an open standard ECC system, despite a lower cardiac index. This phenomenon can be explained through a significant lower haemodilution and, therefore, a higher concentration of haemoglobin.

Is carotid endarterectomy a trainee operation?

BACKGROUND: Recent dramatic changes in surgical training resulting from working-hour regulations may lead to lack of competence. Traditionally, carotid surgery has been the domain of specialists. This study was designed to compare the outcome of carotid endarterectomy performed by vascular surgical trainees versus vascular surgeon (VS). METHODS: A retrospective study of 1,379 consecutive patients who underwent carotid endarterectomy as the sole procedure under local or general anesthesia (from 1995-2004) was performed. All patients were admitted to the intensive care unit for 24 hours. Trainees performed 475 (34.5%) and vascular specialists performed 904 (65.5%) operations. RESULTS: Patient characteristics with regard to preoperative neurological status were similar. Trainees operated on 61.4% symptomatic patients and VS on 56.8% (P = 0.09). Shunt use did not differ (16% trainee vs. 17.8% VS). Clamping time and total operating time were longer among trainees (41.9 vs. 33.5 min, P < 0.001; and 121.2 vs. 101.8 min, P < 0.001, respectively). Postoperative stroke and death rates (3.2% vs. 3.1% and 0.4% vs. 0.9%, respectively) did not differ. Peripheral nerve complications were more common among trainees (12.2% vs. 6.5%; P < 0.0001); 99.6% of these nerve injuries had resolved at 3 months' follow-up. CONCLUSIONS: Carotid endarterectomy can be performed safely by a trainee vascular surgeon when assisted and supervised by a specialist vascular surgeon.

Generalized dilating diathesis in patients with popliteal arterial aneurysm.

BACKGROUND: Aim of this study was to analyse the relationship between popliteal artery aneurysm (PAA) and generalized arteriomegaly. PATIENTS AND METHODS: In this consecutive serie, thirty-three patients (1 woman, mean age 69.7 +/- 9.6 years) undergoing PAA repair between 1996 and 2000 agreed to participate in a duplex screening program to assess the diameters of the infrarenal abdominal aorta, common and external iliac, common and superficial femoral and contralateral popliteal arteries as well as common carotid and brachial arteries. RESULTS: The prevalence of arteriomegaly and aneurysmal disease, respectively, was as follows: abdominal aorta 15/33 (45.5%) and 8/33 (24.2%), common iliac artery 34/66 (51.5%) and 23/66 (34.8%), common femoral artery 55/66 (83.3%) and 7/66 (10.6%) as well as contralateral popliteal artery 7/33 (21.2%) 15/33 (45.5%). Significantly larger carotid artery diameters were found comparing PAA patients with age- and body surface adjusted healthy controls (p < 0.001). Furthermore, patients with multiple peripheral arterial aneurysms had significantly larger diameters of the brachial (p < 0.02) and external iliac (p < 0.005). CONCLUSIONS: Our findings support the hypothesis of a diathesis for a generalized arteriomegaly with a predilection for further aneurysms of the abdominal aorta, iliac arteries, femoral and contralateral popliteal arteries in patients with PAA.

Local versus general anaesthesia for carotid endarterectomy--improving the gold standard ?

OBJECTIVE: Carotid endarterectomy (CEA) reduces stroke risk among selected patients. To achieve this, low operative risk is crucial. Outcome may depend on whether local (LA) or general (GA) anaesthesia is used. The aim of our study was to assess the risks of CEA under LA compared with that under GA. Primary endpoint was neurological outcome. DESIGN: Retrospective study, prospective data bank. PATIENTS AND METHODS: Analysis was performed of hospital charts from 1341 consecutive patients undergoing carotid endarterectomy between January 1995 and December 2004. The patients were divided into two groups according to intraoperative anaesthesia (LA 465 patients or GA 876 patients). RESULTS: Cerebral complications (transient ischemic attacks and stroke combined) were more common in the GA group (6.9% vs. 3.4%, p<0.009, relative risk 0.48, 95% confidence interval (CI) 0.272-0.839). Mortality was 0.5% (LA) vs. 0.8% (GA). Combined death and stroke rate were not different between groups (4.1% vs. 3.2%). Postoperative hypertension episodes were more common in the LA group (47.7%, vs. GA 20.4%, p <0.001). Haematomas requiring surgery were more common in the GA group (6.4% vs. 3.0%, p<0.02). CONCLUSION: CEA can be performed safely under LA. It may improve the results and lead to better neurological outcome as compared to GA. Risk factor analysis did not reveal specific risk groups.

Small is beautiful: why profundaplasty should not be forgotten.

BACKGROUND: Surgical profundaplasty (SP)is used mainly as an adjunct to endovascular management of peripheral vascular disease (PAD) today. Results from earlier series of profundaplasty alone have been controversial, especially regarding its hemodynamic effect. The question is: Can profundaplasty alone still be useful? Our aim was to evaluate its role in the modern management of vascular patients. METHODS: This was a retrospective outcome study. A consecutive series of 97 patients (106 legs) from January 2000 through December 2003 were included. In 55 (52%) legs, the superficial femoral artery was occluded. These patients were included in the current analysis. Of these patients 14 (25%) were female. Mean age was 71 ((11) years. Nineteen (35%) were diabetic. The indication for operation was claudication in 29 (53%), critical leg ischemia (CLI) in 26 (47%), either with rest pain in 17 (31%), or ulcer/gangrene in 9 (16%). Endarterectomy with patch angioplasty with bovine pericardium was performed in all cases. Mean follow-up was 33 ( 14 months. Mean preoperative ankle brachial index (ABI) was 0.6. Sustained clinical efficacy was defined as upward shift of 1 or greater on the Rutherford scale without repeat target limb revascularization (TLR) or amputation. Mortality, morbidity, need for TLR, or amputation were separate endpoints. RESULTS: Postoperatively, ABI was significantly improved (mean = 0.7), in 24 (44%) by more than 0.15. At three years, cumulative clinical success rate was 80%. Overall, patients with claudication had a better outcome than those with CLI (p = 0.04). Two (4%) major amputations and 2 (4%) minor ones were performed, all in patients with CLI. None of the 9 (16%) ulcers healed. CONCLUSION: Profundaplasty is still a valuable option for patients with femoral PAD and claudication without tissue loss. It is a straightforward procedure that combines good efficacy with low complication rates. Further endovascular treatment may be facilitated. It is not useful for patients with the combination of critical ischemia and tissue loss.