Effect of aspirin in vascular surgery in patients from a randomized clinical trial (POISE-2).

BACKGROUND: In the POISE-2 (PeriOperative ISchemic Evaluation 2) trial, perioperative aspirin did not reduce cardiovascular events, but increased major bleeding. There remains uncertainty regarding the effect of perioperative aspirin in patients undergoing vascular surgery. The aim of this substudy was to determine whether there is a subgroup effect of initiating or continuing aspirin in patients undergoing vascular surgery. METHODS: POISE-2 was a blinded, randomized trial of patients having non-cardiac surgery. Patients were assigned to perioperative aspirin or placebo. The primary outcome was a composite of death or myocardial infarction at 30 days. Secondary outcomes included: vascular occlusive complications (a composite of amputation and peripheral arterial thrombosis) and major or life-threatening bleeding. RESULTS: Of 10 010 patients in POISE-2, 603 underwent vascular surgery, 319 in the continuation and 284 in the initiation stratum. Some 272 patients had vascular surgery for occlusive disease and 265 had aneurysm surgery. The primary outcome occurred in 13·7 per cent of patients having aneurysm repair allocated to aspirin and 9·0 per cent who had placebo (hazard ratio (HR) 1·48, 95 per cent c.i. 0·71 to 3·09). Among patients who had surgery for occlusive vascular disease, 15·8 per cent allocated to aspirin and 13·6 per cent on placebo had the primary outcome (HR 1·16, 0·62 to 2·17). There was no interaction with the primary outcome for type of surgery (P = 0·294) or aspirin stratum (P = 0·623). There was no interaction for vascular occlusive complications (P = 0·413) or bleeding (P = 0·900) for vascular compared with non-vascular surgery. CONCLUSION: This study suggests that the overall POISE-2 results apply to vascular surgery. Perioperative withdrawal of chronic aspirin therapy did not increase cardiovascular or vascular occlusive complications. Registration number: NCT01082874 ( http://www.clinicaltrials.gov).

Weight-adjusted tinzaparin for venous thromboembolism prophylaxis in bariatric surgery patients weighing 160 kg or more.

INTRODUCTION: Bariatric surgery patients experience an increased risk of venous thromboembolism (VTE), however, the optimal dose of low-molecular-weight heparin for VTE prophylaxis remains uncertain. Currently, St. Joseph's Healthcare Hamilton utilizes a weight-adjusted tinzaparin dosage (50 to 75 units/kg rounded to nearest pre-filled syringe) for postoperative VTE prophylaxis. OBJECTIVES: This study analyzed the safety of weight-adjusted tinzaparin for VTE prophylaxis in bariatric surgery patients weighing ≥160 kg. METHODS: This was a retrospective study involving patients weighing ≥160 kg that underwent bariatric surgery from September 2015 to September 2019. Patients received a single dose of weight-adjusted subcutaneous unfractionated heparin (UFH) [5000 or 7500 IU] immediately prior to surgery, subcutaneous UFH [5000 IU, 7500 IU, or unspecified] immediately postoperatively, and either 10,000 or 14,000 IU of tinzaparin, beginning on the day after surgery, for 10 days. Intra-operative sequential compression devices could be used at the attending surgeon's discretion. Occurrence of VTE and major bleeding within 30 days of surgery were assessed. RESULTS: A total of 389 patients were included for analysis, all patients received in-hospital follow-up while 349 patients had also 30-day follow-up. For the primary safety and efficacy analysis of in-hospital events, VTE and major bleeding rates were 0.26% [95% CI 0.01%-1.44%] (1/389) and 0.77% [95% CI 0.21%-2.24%] (3/389) respectively. For patients with 30-day follow-up VTE and major bleeding rates were 0.57% [95% CI 0.1%-2.07%] (2/349) and 1.43% [95% CI 0.61%-3.3%] (5/349) respectively. CONCLUSIONS: Weight-adjusted tinzaparin was associated with a low risk of bleeding and VTE events, supporting its use for VTE prophylaxis for patients weighing ≥160 kg.

Weight-adjusted tinzaparin for the prevention of venous thromboembolism after bariatric surgery.

Essentials The optimal dose and duration of thromboprophylaxis after bariatric surgery are unclear. We evaluated the safety of weight-adjusted tinzaparin prophylaxis in 1212 patients. In-hospital rates of venous thromboembolism and major bleeding were 0.2% and 1.8% respectively. In a sub-set of patients, trough anti-Xa levels did not show excessive anticoagulant activity. SUMMARY: Background Patients undergoing bariatric surgery are at moderate to high risk of venous thromboembolism (VTE). The optimal dose and duration of anticoagulant prophylaxis is uncertain. Objective To evaluate the safety of extended-duration weight-adjusted tinzaparin after bariatric surgery. Patients/methods We conducted a single-center retrospective cohort study of consecutive patients undergoing bariatric surgery who received weight-adjusted tinzaparin 4500-14 000 IU daily (75 IU kg-1 rounded to the nearest prefilled syringe) for 10 days after surgery (7-9 days post-hospital discharge). Primary safety outcomes were the frequency of VTE and major bleeding within 30 days of surgery in patients receiving at least one dose of tinzaparin. Results A total of 1279 patients undergoing bariatric surgery between July 2009 and December 2012 were reviewed, of whom 1212 received weight-adjusted tinzaparin. Safety outcomes were collected for 819 patients at 30 days, and for 1212 patients in-hospital only. The median age was 45.0 years, median weight was 130.0 kg and 98.8% of patients underwent gastric bypass or sleeve gastrectomy. In patients completing 30 days of follow-up, VTE occurred in 4/819 (0.5%) and major bleeding occurred in 13/819 patients (1.6%). In-hospital rates of VTE and major bleeding during surgical admission were 3/1212 (0.2%) and 22/1212 (1.8%), respectively. Conclusions Extended thromboprophylaxis with weight-adjusted tinzaparin appears to be a safe strategy after bariatric surgery, with low rates of postoperative VTE and major bleeding.

The effect of bariatric surgery on serum 25-OH vitamin D levels: a systematic review and meta-analysis.

BACKGROUND: Concerns have emerged about post-operative decreases in calcium and vitamin D following bariatric surgery. This review explores changes in metabolic bone health in persons with obesity undergoing gastric bypass surgery compared to non-surgical controls, providing an updated and comprehensive perspective on the literature. METHODS: An electronic search was conducted in MEDLINE, Pubmed, EMBASE and Cochrane databases to 8 November 2016. Eligible trials included randomized controlled trials or controlled observational studies of patients who have undergone laparoscopic gastric bypass surgery. Statistical analysis was carried out using the Cochrane Collaboration Review Manager (RevMan 5.0), and a random effects model was implemented. Outcomes were expressed as weighted mean difference (WMD). The primary outcome examined was change in 25-OH-D levels at 12 months post surgery, and secondary outcomes included change in bone mineral density (BMD) measurements at 12 months post surgery at the lumbar spine (LS) and total hip (TH). RESULTS: At 12 months, there was no significant difference in 25-OH vitamin D in the surgical group compared to controls (WMD = 6.79%; 95% CI: -9.01, 22.59; p = 0.40; I2 = 68%). There was no statistically significant difference between fracture risk in the surgical population compared to controls (RR = 1.24; 95% CI: 0.99, 1.56; p = 0.06; I2 = 0%). A significant BMD reduction was however shown at the TH (WMD, -7.33%, 95% CI = -8.70 to -5.97, p < .001, I2 = 0%), and a trend towards decline was observed at the LS (WMD, -1.73%, 95% CI = -3.56 to 0.11, p = 0.06, I2 = 0%). Changes at 24 months for applicable outcomes were similar to the results at 12 months. CONCLUSIONS: Bariatric surgery may compromise metabolic bone health, but the paucity of high-quality literature limits conclusions.

Human papillomavirus (HPV) cervical lesions: results from 300 Italian women studied with DNA hybridization techniques and morphology.

Human papillomavirus cervical infection was investigated in a series of 300 unselected women by comparing morphological diagnoses (cytology and histology) with results of DNA hybridization techniques (filter in situ hybridization of DNA from exfoliated cervical cells and Southern blot analysis of HPV-DNA in cervical biopsy specimens). The prevalence of HPV cervical infection diagnosed by PAP smears was 11.6%. Despite disadvantages, filter in situ hybridization was confirmed to be particularly useful for screening purposes to detect HPV in cervical scrapings. In 3 cases it was the only applicable method for diagnosing "high-risk" HPV infection. Southern blot hybridization of tissue DNA with HPV 16-DNA revealed the presence of this virus in 8 cases, and HPV 31-DNA and HPV 42-DNA in 1 case each.