Variation in Surgical Treatment of Abdominal Aortic Aneurysms With Small Aortic Diameters in the Netherlands

Objective: To evaluate reasons to deviate from aneurysm diameter thresholds, and focus on the difference in how Dutch vascular surgical units (VSUs) perceive their deviation and their actual deviation. Background: Guidelines recommend surgical treatment for asymptomatic abdominal aortic aneurysms (AAAs) with a diameter of at least 55 mm for men and 50 mm for women. We evaluate reasons to deviate from these guidelines, and focus on the difference in how Dutch vascular surgical units (VSUs) perceive their deviation and their actual deviation. Methods: All patients undergoing elective AAA repair between 2013 and 2016 registered in the Dutch Surgical Aneurysm Audit (DSAA) were included. Surgery at diameters of <55 mm for men and <50 mm for women were considered guideline deviations. National deviation and hospital variation in deviation were evaluated over time. Questionnaires were distributed among all Dutch VSUs, inquiring for acceptable reasons for guideline deviation. VSUs were asked to estimate the guideline deviation percentage in their hospital which was then compared with their DSAA percentage. Results: In all, 9039 patients were included. In 15%, we found guideline deviation, varying from 2% to 40% between VSUs. Over time, 21 VSUs were identified with a lower percentage of deviation than the national mean each year and 8 VSUs with a higher percentage. 44/60 VSUs completed the questionnaire. Most commonly reported reasons to deviate were concomitant large iliac diameter (91%) and saccular aneurysm (82%). The majority of the VSUs (77%) estimated their guideline deviation to be <5%. Eleven VSUs (25%) estimated their deviation concordant with their DSAA percentage, but 75% of VSUs underestimated their deviation. Conclusions: Dutch VSUs regularly deviate from the guidelines regarding aneurysm diameter, with variation between VSUs. Consensus exists amongst VSUs on acceptable reasons for guideline deviations; however, the majority underestimates their actual deviation percentage

Data verification of nationwide clinical quality registries

Background Clinical auditing is an emerging instrument for quality assessment and improvement. Moreover, clinical registries facilitate medical research as they provide ‘real world’ data. It is important that entered data are robust and reliable. The aim of this study was to describe the evolving procedure and results of data verification within the Dutch Institute for Clinical Auditing (DICA). Methods Data verification performed on several (disease‐specific) clinical registries between 2013 and 2015 was evaluated. Sign‐up, sample size and process of verification were described. For each procedure, hospitals were visited by external data managers to verify registered data. Outcomes of data verification were completeness and accuracy. An assessment of the quality of data was given p

Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection

BACKGROUND Clostridium difficile is the most common cause of infectious diarrhea in hospitalized patients. Recurrences are common after antibiotic therapy. Actoxumab and bezlotoxumab are human monoclonal antibodies against C. difficile toxins A and B, respectively. METHODS We conducted two double-blind, randomized, placebo-controlled, phase 3 trials, MODIFY I and MODIFY II, involving 2655 adults receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection. Participants received an infusion of bezlotoxumab (10 mg per kilogram of body weight), actoxumab plus bezlotoxumab (10 mg per kilogram each), or placebo; actoxumab alone (10 mg per kilogram) was given in MODIFY I but discontinued after a planned interim analysis. The primary end point was recurrent infection (new episode after initial clinical cure) within 12 weeks after infusion in the modified intention-to-treat population. RESULTS In both trials, the rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% [67 of 386] vs. 28% [109 of 395]; adjusted difference, −10.1 percentage points; 95% confidence interval [CI], −15.9 to −4.3; P<0.001; MODIFY II: 16% [62 of 395] vs. 26% [97 of 378]; adjusted difference, −9.9 percentage points; 95% CI, −15.5 to −4.3; P<0.001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% [61 of 383] vs. 28% [109 of 395]; adjusted difference, −11.6 percentage points; 95% CI, −17.4 to −5.9; P<0.001; MODIFY II: 15% [58 of 390] vs. 26% [97 of 378]; adjusted difference, −10.7 percentage points; 95% CI, −16.4 to −5.1; P<0.001). In prespecified subgroup analyses (combined data set), rates of recurrent infection were lower in both groups that received bezlotoxumab than in the placebo group in subpopulations at high risk for recurrent infection or for an adverse outcome. The rates of initial clinical cure were 80% with bezlotoxumab alone, 73% with actoxumab plus bezlotoxumab, and 80% with placebo; the rates of sustained cure (initial clinical cure without recurrent infection in 12 weeks) were 64%, 58%, and 54%, respectively. The rates of adverse events were similar among these groups; the most common events were diarrhea and nausea. CONCLUSIONS Among participants receiving antibiotic treatment for primary or recurrent C. difficile infection, bezlotoxumab was associated with a substantially lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo. The addition of actoxumab did not improve efficacy. (Funded by Merck; MODIFY I and MODIFY II ClinicalTrials.gov numbers, NCT01241552 and NCT01513239.

Treatment Outcome Trends for Non-Ruptured Abdominal Aortic Aneurysms: A Nationwide Prospective Cohort Study

Objective: The Dutch Surgical Aneurysm Audit (DSAA) initiative was established in 2013 to monitor and improve nationwide outcomes of aortic aneurysm surgery. The objective of this study was to examine whether outcomes of surgery for intact abdominal aortic aneurysms (iAAA) have improved over time. Methods: Patients who underwent primary repair of an iAAA by standard endovascular (EVAR) or open surgical repair (OSR) between 2014 and 2019 were selected from the DSAA for inclusion. The primary outcome was peri-operative mortality trend per year, stratified by OSR and EVAR. Secondary outcomes were trends per year in major complications, textbook outcome (TbO), and characteristics of treated patients. The trends per year were evaluated and reported in odds ratios per year. Results: In this study, 11 624 patients (74.8%) underwent EVAR and 3 908 patients (25.2%) underwent OSR. For EVAR, after adjustment for confounding factors, there was no improvement in peri-operative mortality (aOR [adjusted odds ratio] 1.06, 95% CI 0.94 – 1.20), while major complications decreased (2014: 10.1%, 2019: 7.0%; aOR 0.91, 95% CI 0.88 – 0.95) and the TbO rate increased (2014: 68.1%, 2019: 80.9%; aOR 1.13, 95% CI 1.10 – 1.16). For OSR, the peri-operative mortality decreased (2014: 6.1%, 2019: 4.6%; aOR 0.89, 95% CI 0.82 – 0.98), as well as major complications (2014: 28.6%, 2019: 23.3%; aOR 0.95, 95% CI 0.91 – 0.99). Furthermore, the proportion of TbO increased (2014: 49.1%, 2019: 58.3%; aOR 1.05, 95% CI 1.01 – 1.10). In both the EVAR and OSR group, the proportion of patients with cardiac comorbidity increased. Conclusion: Since the establishment of this nationwide quality improvement initiative (DSAA), all outcomes of iAAA repair following EVAR and OSR have improved, except for peri-operative mortality following EVAR which remained unchanged