R.J.F. Laheij

Rupture of infra-renal aortic aneurysm after endovascular repair: a series from EUROSTAR registry.

OBJECTIVESnAlthough small, the risk of rupture after EVAR remains a major concern. The aim of this study was to identify mechanisms of late aneurysm rupture after endovascular repair.nnnMETHODSnPatients who suffered a proven aneurysm rupture after EVAR were identified from the EUROSTAR (European Collaborators on Stent-graft Techniques for Abdominal Aortic Aneurysm Repair) registry. Complications preceding rupture were studied to identify common patterns and possible mechanisms of late rupture.nnnRESULTSnA rupture was documented in 34 patients resulting in death of 21 (62%). Adverse events documented during previous follow-up in these patients included endoleak (30%), migration (18%), limb occlusion (12%) and kinking (12%). The findings at time of rupture were documented in 24 patients and including endoleak: Type III (10), Type I (9), Type II (1); stent-graft disintegration (2) and migration (3). Aneurysm diameter changes could be ascertained in 24 patients and had increased in only seven.nnnCONCLUSIONnThe importance of graft-related endoleak, stent-graft disintegration and migration in the causation of aneurysm rupture was confirmed. Poor compliance with follow-up schedule was also identified as a common feature. However, the absence of complications in some patients, who attended regularly for follow-up, highlights the difficulty of predicting rupture after EVAR.

Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts compare?

Purpose: To compare differences in the applicability and incidence of postoperative adverse events among stent-grafts used for repair of infrarenal aortic aneurysms. Methods: An analysis of 6787 patients from the EUROSTAR Registry database was conducted to compare aneurysm morphological features, patient characteristics, and postoperative events for the AneuRx, EVT/Ancure, Excluder, Stentor, Talent, and Zenith devices versus the Vanguard device (control) and each other. Annual incidence rates of complications were determined, and risks were compared using the Cox proportional hazards analysis. Results: The annual incidence rates were: device-related endoleak (types I and III) 6% (range 4%-10%), type II endoleak 5% (range 0.3%-11%), migration 3% (range 0.5%-5%), kinking 2% (range 1%-5%), occlusion 3% (range 1%-5%), rupture 0.5% (range 0%-1%), and all-cause mortality 7% (range 5%-8%). After adjustment for factors influencing outcome, AneuRx, Excluder, Talent, and Zenith devices were associated with a lower risk of migration, kinking, occlusion, and secondary intervention compared to the Vanguard device. Significant increased risk for conversion (EVT/Ancure) and reduced risk of aneurysm rupture (AneuRx and Zenith) and all-cause mortality (Excluder) were found compared to the Vanguard device. Conclusions: Significant differences exist between stent-grafts of different labels in terms of applicability and complications during intermediate to long-term follow-up. Since each stent-graft has its drawbacks, no single label can be identified as the best. It is reassuring that developments in stent-grafts indeed result in better performance than the early stent-grafts. However, a single device incorporating all the perceived improvements should still be pursued.

Effect of the Antidepressant Venlafaxine in Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Trial

BACKGROUND & AIMSnAntidepressants could be effective in the treatment of functional gastrointestinal disorders through their anticholinergic and pain-modulating effects. Previous studies with these drugs lacked sufficient power and were predominantly conducted in patients with irritable bowel syndrome. This study aimed to assess the effectiveness of the serotonin and norepinephrine reuptake inhibitor venlafaxine in patients with functional dyspepsia.nnnMETHODSnThis was a multi-center, randomized, double-blind, placebo-controlled trial. Participants had persistent dyspeptic symptoms and underwent upper gastrointestinal endoscopy in a secondary care hospital to exclude organic abnormalities. They were randomly assigned to receive 8 weeks of treatment with either venlafaxine XR (2 weeks 75 mg once daily, 4 weeks 150 mg once daily, and 2 weeks 75 mg once daily) or placebo. Symptoms, health-related quality of life, anxiety, and depression were assessed before and at 4, 8, 12, and 20 weeks after inclusion.nnnRESULTSnOne hundred sixty patients were randomized; 56% and 73% of participants completed treatment with venlafaxine or placebo, respectively, according to protocol. There was no difference in proportions of symptom-free patients after 8 weeks of treatment or at 20 weeks after inclusion, with venlafaxine in comparison to placebo (37% and 39%, respectively; odds ratio [OR], 0.8; 95% confidence interval [CI], 0.3-2.1; and 42% and 41%, respectively; OR, 3.1; 95% CI, 0.9-12.6). Per-protocol analysis did not reveal any differences between venlafaxine and placebo either (38% and 39% symptom-free, respectively; OR, 1.0; 95% CI, 0.4-2.4 at 8 weeks).nnnCONCLUSIONSnTreatment with the selective serotonin and norepinephrine reuptake inhibitor venlafaxine is not more effective than placebo in patients with functional dyspepsia.

Evaluation of a gastrointestinal symptoms questionnaire

Questionnaires are widely used instruments to monitor gastrointestinal (GI) symptoms. However, few of these questionnaires have been formally evaluated. We sought to evaluate our GI symptoms questionnaire in terms of clarity and reproducibility. Primary care patients referred for open access Helicobacter pylori urea breath testing reported GI symptoms (type+severity) and demographic information by written questionnaire. In an interview, patients gave a personal description of the meaning of the GI symptoms on the questionnaire. Patients’ descriptions of GI symptoms were compared with current definitions. Symptom severity scores were compared before and after, interview versus questionnaire. Of the 45 patients included, 19 (42%) described all symptoms correctly, whereas 17 (38%) described one symptom incorrectly. None of the patients made more than three mistakes. Regurgitation was the most common incorrectly described symptom (16 patients [36%]), whereas the other individual symptoms were well explained. Symptom severities before the interview, after the interview and reported by questionnaire (mean value±SEM) were 2.1 ± 0.2, 2.1 ± 0.2, and 1.5 ± 0.2 points on a 7-point Likert scale (0–6), respectively. Mean severity reported by interview (95% CI) was 1.4 (1.3–1.5) times higher than reported by questionnaire (P < .05). In conclusion, the GI symptom questionnaire is understandable and has good reproducibility for measuring the presence of GI symptoms, although symptom severity is consistently rated higher when reported by interview.

Effect and cost-effectiveness of step-up versus step-down treatment with antacids, H2-receptor antagonists, and proton pump inhibitors in patients with new onset dyspepsia (DIAMOND study): a primary-care-based randomised controlled trial.

BACKGROUNDnSubstantial physician workload and high costs are associated with the treatment of dyspepsia in primary health care. Despite the availability of consensus statements and guidelines, the most cost-effective empirical strategy for initial management of the condition remains to be determined. We compared step-up and step-down treatment strategies for initial management of patients with new onset dyspepsia in primary care.nnnMETHODSnPatients aged 18 years and older who consulted with their family doctor for new onset dyspepsia in the Netherlands were eligible for enrolment in this double-blind, randomised controlled trial. Between October, 2003, and January, 2006, 664 patients were randomly assigned to receive stepwise treatment with antacid, H(2)-receptor antagonist, and proton pump inhibitor (step-up; n=341), or these drugs in the reverse order (step-down; n=323), by use of a computer-generated sequence with blocks of six. Each step lasted 4 weeks and treatment only continued with the next step if symptoms persisted or relapsed within 4 weeks. Primary outcomes were symptom relief and cost-effectiveness of initial management at 6 months. Analysis was by intention to treat (ITT); the ITT population consisted of all patients with data for the primary outcome at 6 months. This trial is registered with ClinicalTrials.gov, number NCT00247715.nnnFINDINGSn332 patients in the step-up, and 313 in the step-down group reached an endpoint with sufficient data for evaluation; the main reason for dropout was loss to follow-up. Treatment success after 6 months was achieved in 238 (72%) patients in the step-up group and 219 (70%) patients in the step-down group (odds ratio 0.92, 95% CI 0.7-1.3). The average medical costs were lower for patients in the step-up group than for those in the step-down group (euro228 vs euro245; p=0.0008), which was mainly because of costs of medication. One or more adverse drug events were reported by 94 (28%) patients in the step-up and 93 (29%) patients in the step-down group. All were minor events, including (other) dyspeptic symptoms, diarrhoea, constipation, and bad/dry taste.nnnINTERPRETATIONnAlthough treatment success with either step-up or step-down treatment is similar, the step-up strategy is more cost effective at 6 months for initial treatment of patients with new onset dyspeptic symptoms in primary care.

Meta-analysis: the diagnostic value of alarm symptoms for upper gastrointestinal malignancy.

Background :u2002With the advent of empirical treatment strategies for patients with dyspeptic symptoms, it becomes increasingly important to select patients with a high risk of having cancer for immediate endoscopy. Usually alarming symptoms are used for this matter, but their diagnostic value is by no means clear.

Endovascular stenting of abdominal aortic aneurysm in patients unfit for elective open surgery

Endovascular aneurysm repair is useful for patients who are judged unfit for surgery. We investigated the outcome of endovascular repair of abdominal aortic aneurysm in patients fit and unfit for surgery. The 1-year cumulative survival for patients unfit for surgery and patients unfit for general anaesthesia was 20% and 23%, respectively. The overall health status of patients was an important predictor of survival after endovascular repair. The risks of endovascular aneurysm repair might, therefore, exceed that of non-operative management. Caution should be used when advising these patients about endovascular repair.

Rapid detoxification from opioid dependence under general anaesthesia versus standard methadone tapering: abstinence rates and withdrawal distress experiences

The aim of this work was to study abstinence rates and withdrawal effects of rapid detoxification of opioid‐dependents under general anaesthesia (RD‐GA) compared to standard methadone tapering (SMT) using a prospective clinical trial with a follow‐up of 3 months, as a preliminary study at the Novadic addiction centre in St Oedenrode and St Joseph Hospital in Veghel, the Netherlands. Thirty opioid‐dependent patients took part. Outcome measures included urine toxicology screening for opiates to determine abstinence and presence of objective and subjective opioid withdrawal distress symptoms. Statistically significant differences in abstinence rate between RD‐GA and SMT were present after one (RD‐GA 100% vs. SMT 40%, p <0.01) and 2 months (RD‐GA 93% vs. SMT 33%, p <0.01). After 3 months the difference in abstinence was still substantial, but no longer statistically significant (RD‐GA 67% vs. SMT 33%, p =0.14). Objective and subjective withdrawal symptoms showed largely identical outcomes and were equally low in the two groups for those who remained in the study. There was a considerably higher percentage of abstinence in the RD‐GA group after 1, 2 and 3 months of follow‐up accompanied by relatively mild withdrawal symptoms of shorter duration. However, if one completes SMT the data suggest a greater chance of staying clean in the long term than those completing RD‐GA.

Effect of a Specific Cyclooxygenase-Gene Polymorphism (A-842G/C50T) on the Occurrence of Peptic Ulcer Hemorrhage

Cyclooxygenases (COX) catalyze the conversion of arachidonic acid to prostaglandins (PGs). COX-inhibiting drugs, such as nonsteroidal anti-inflammatory drugs (NSAIDs), increase the risk for peptic ulcer disease. As a corollary, COX gene polymorphisms could be important in the pathogenesis of peptic ulcer disease because these affect prostaglandin formation and impair its protective effect at the level of the gastric mucosa. This study was designed to investigate the association between the functional single–nucleotide polymorphism, A-842G/C50T, in the COX-1 gene and peptic ulcer bleeding. We obtained DNA samples from 106 patients who underwent upper gastrointestinal endoscopy because of bleeding peptic ulcer disease and from 88 healthy control subjects. Genetic polymorphism in A-842G/C50T was determined by PCR followed by restriction-fragment-length-polymorphism analysis. Adjusted logistic regression analysis was performed to evaluate the associations. Risk factors associated with peptic ulcer bleeding were male gender (odds ratio, 4.78; 95% confidence interval, 2.6–8.8) and NSAID/aspirin-use (odds ratio, 38.39; 95% confidence interval, 14.2–103.6). The A-842G/C50T heterozygote was less frequent in peptic ulcer bleeding (n = 7) compared with healthy control subjects (n = 11). The adjusted risk for peptic ulcer bleeding among individuals who were heterozygote for the A-842G/C50T polymorphism was 0.75 (range, 0.19–3.01) compared with wild type. The COX-1 A-842G/C50T SNP does not influence the risk for developing peptic ulcer bleeding.

Psychopathology is associated with dyspeptic symptom severity in primary care patients with a new episode of dyspepsia.

Backgroundu2002 Personality and psychiatric disorders are reported to be more common in dyspeptic patients with severe complaints, but it remains unclear whether this association exists for patients with mild and moderate dyspepsia.