Intravenous human immunoglobulin utilization patterns and cost analysis in a Malaysian tertiary referral hospital.

INTRODUCTION: While intravenous human immunoglobulin therapy is potentially lifesaving for rare diseases, the significant costs associated with its usage warrant due attention. This study evaluated the costs and prescribing patterns of IVIg. METHODS: This was a retrospective analysis of medical records in a tertiary hospital. The evidence category IIA and below, as well as strength of recommendations level B and below were classified as lower evidence category and lower strength of recommendation, respectively. Patients' demographic data, indications, dosing regimen, physician specialty were retrieved from medical records, while the cost was derived based on total prescribed doses. RESULTS: Out of 78 patients, more than half of the patients were prescribed with off-label IVIg based on MOHM Formulary (52, 66.7%), FDA indications (52, 66.7%) and EMA indications (46, 59.0%). 37 (47.4%) cases used IVIg for indications with lower evidence category and 52 (66.7%) cases with lower strength of recommendation. The total cost of IVIg use within the 2-year period was RM 695,426.36, with RM267,993.40 (38.5%) spent for indications with lower evidence category. Immunoglobulin use in rheumatology and neurology cases were associated with lower evidence category (p < 0.001). CONCLUSIONS: A high proportion of off-label immunoglobulin use was observed. A timely update of prescribing policy, standardization of prescribing guidelines may promote appropriate immunoglobulin prescribing and justify expenses.

The impact of preoperative glycated hemoglobin (HbA1c) on postoperative complications after elective major abdominal surgery: a meta-analysis.

BACKGROUND: Diabetes is a risk factor for postoperative complications. Previous meta-analyses have shown that elevated glycated hemoglobin (HbA1c) levels are associated with postoperative complications in various surgical populations. However, this is the first meta-analysis to investigate the association between preoperative HbA1c levels and postoperative complications in patients undergoing elective major abdominal surgery. METHODS: PRISMA guidelines were adhered to for this study. Six databases were searched up to April 1, 2020. Primary studies investigating the effect of HbA1c levels on postoperative complications after elective major abdominal surgery were included. Risk of bias and quality of evidence assessments were performed. Data were pooled using a random effects model. Meta-regression was performed to evaluate different HbA1c cut-off values. RESULTS: Twelve observational studies (25,036 patients) were included. Most studies received a 'good' and 'moderate quality' score using the NOS and GRADE, respectively. Patients with a high HbA1c had a greater risk of anastomotic leaks (odds ratio [OR]: 2.80, 95% CI [1.63, 4.83], P < 0.001), wound infections (OR: 1.21, 95% CI [1.08, 1.36], P = 0.001), major complications defined as Clavien-Dindo [CD] 3-5 (OR: 2.16, 95% CI [1.54, 3.01], P < 0.001), and overall complications defined as CD 1-5 (OR: 2.12, 95% CI [1.48, 3.04], P < 0.001). CONCLUSIONS: An HbA1c between 6% and 7% is associated with higher risks of anastomotic leaks, wound infections, major complications, and overall postoperative complications. Therefore, guidelines with an HbA1c threshold > 7% may be putting pre-optimized patients at risk. Future randomized controlled trials are needed to explore causation before policy changes are made.

Transcatheter aortic valve replacement for aortic regurgitation in Asians: TAVR for aortic regurgitation in Asians.

AIMS: Although surgical aortic valve replacement (SAVR) is currently the recommended intervention for patients with native AR without aortic stenosis, a significant proportion of Asian patients undergo transcatheter aortic valve replacement (TAVR), which has not been studied fully for safety and outcomes. This systematic review aims to examine the characteristics and outcomes of Asian patients with pure native aortic regurgitation (AR) undergoing TAVR. METHODS AND RESULTS: PubMed, Embase, Scopus, Web of Science and Cochrane CENTRAL were systematically searched for randomised controlled trials, observational studies and case reports published  from inception to 2 April 2020, involving patients of Asian ethnicity with pure native aortic regurgitation who had undergone TAVR. Our primary outcome was all-cause mortality, with secondary outcomes including all major complications. Five studies (n=274 patients) and eight case reports were included. Device success was reported in 94.9% of the patients, the all-cause mortality rate was 4.4%, 2.5% were converted to SAVR, 1.7% had post-operative paravalvular leak and 6.7% required permanent pacemaker implantation. CONCLUSIONS: TAVR has demonstrated acceptable safety and efficacy in Asian patients with pure AR displaying low mortality rates and few adverse outcomes.

Impact of preoperative HbA1c on postoperative complications after elective major abdominal surgery: a systematic review protocol.

INTRODUCTION: Diabetes has an increasing worldwide prevalence. It is known to be a predisposing factor for postoperative complications. Preoperative glycaemic control strategies should be pursued as glycaemic control could serve as a modifiable risk factor. Glycated haemoglobin (HbA1c), a marker of 3-month average glycaemic control, has been shown in meta-analyses to predict postoperative complications in cardiothoracic, bariatric and orthopaedic surgery. However, there is no meta-analysis in the major abdominal surgery population, in whom morbidity may be higher due to the nature of the surgery. Understanding the association between HbA1c and postoperative complications could help in preoperative risk prognostication, counselling and glycaemic target selection. The aim of this systematic review and meta-analysis is to evaluate all evidence on the association between preoperative HbA1c and postoperative complications in elective major abdominal surgery, and to investigate the threshold HbA1c level before postoperative complication rates increase. METHODS AND ANALYSIS: This review will be performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. PubMed, Embase, Cochrane Central Register of Controlled Trials, Google Scholar and China National Knowledge Infrastructure will be searched for all original studies. Study selection, data extraction, risk of bias and quality assessment will be conducted by two independent reviewers. The primary outcome is the association between preoperative HbA1c and major postoperative complications (Clavien Dindo 3-5), and the secondary outcome is the association between HbA1c and overall postoperative complications. Data management and synthesis will be performed using Microsoft Excel and Stata to derive pool estimates. ETHICS AND DISSEMINATION: No ethics approval is required as only secondary data will be used. Findings will be disseminated through peer-reviewed journals and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42020167347.