Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications.

OBJECTIVES: Sedation has been established for GI endoscopic procedures in most countries, but it is also associated with an added risk of complications. Reported complication rates are variable due to different study methodologies and often limited sample size. DESIGNS: Acute sedation-associated complications were prospectively recorded in an electronic endoscopy documentation in 39 study centres between December 2011 and August 2014 (median inclusion period 24 months). The sedation regimen was decided by each study centre. RESULTS: A total of 368 206 endoscopies was recorded; 11% without sedation. Propofol was the dominant drug used (62% only, 22.5% in combination with midazolam). Of the sedated patients, 38 (0.01%) suffered a major complication, and overall mortality was 0.005% (n=15); minor complications occurred in 0.3%. Multivariate analysis showed the following independent risk factors for all complications: American Society of Anesthesiologists class >2 (OR 2.29) and type and duration of endoscopy. Of the sedation regimens, propofol monosedation had the lowest rate (OR 0.75) compared with midazolam (reference) and combinations (OR 1.0-1.5). Compared with primary care hospitals, tertiary referral centres had higher complication rates (OR 1.61). Notably, compared with sedation by a two-person endoscopy team (endoscopist/assistant; 53.5% of all procedures), adding another person for sedation (nurse, physician) was associated with higher complication rates (ORs 1.40-4.46), probably due to higher complexity of procedures not evident in the multivariate analysis. CONCLUSIONS: This large multicentre registry study confirmed that severe acute sedation-related complications are rare during GI endoscopy with a very low mortality. The data are useful for planning risk factor-adapted sedation management to further prevent sedation-associated complications in selected patients. TRIAL REGISTRATION NUMBER: DRKS00007768; Pre-results.

Six sequence variants on chromosome 9p21.3 are associated with a positive family history of myocardial infarction: a multicenter registry.

BACKGROUND: Recent genome-wide association studies have identified several genetic loci linked to coronary artery disease (CAD) and myocardial infarction (MI). The 9p21.3 locus was verified by numerous replication studies to be the first common locus for CAD and MI. In the present study, we investigated whether six single nucleotide polymorphisms (SNP) rs1333049, rs1333040, rs10757274, rs2383206, rs10757278, and rs2383207 representing the 9p21.3 locus were associated with the incidence of an acute MI in patients with the main focus on the familial aggregation of the disease. METHODS: The overall cohort consisted of 976 unrelated male patients presenting with an acute coronary syndrome (ACS) with ST-elevated (STEMI) as well as non-ST-elevated myocardial infarction (NSTEMI). Genotyping data of the investigated SNPs were generated and statistically analyzed in comparison to previously published findings of matchable control cohorts. RESULTS: Statistical evaluation confirmed a highly significant association of all analyzed SNP's with the occurrence of MI (p<0.0001; OR: 1.621-2.039). When only MI patients with a positive family disposition were comprised in the analysis a much stronger association of the accordant risk alleles with incident disease was found with odds ratios up to 2.769. CONCLUSIONS: The findings in the present study confirmed a strong association of the 9p21.3 locus with MI particularly in patients with a positive family history thereby, emphasizing the pathogenic relevance of this locus as a common genetic cardiovascular risk factor.

Gender-based differences in long-term outcome after ST-elevation myocardial infarction in patients treated with percutaneous coronary intervention.

BACKGROUND: In the era of fibrinolysis, women suffered from higher early and late mortality rates than men after acute ST-elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention (PCI) has been determined to be the most effective therapy strategy in STEMI. It is not clear if female gender is an independent predictor of a worse long-term prognosis among patients who were systematically treated with PCI. We, therefore, examined the effect of PCI on long-term outcome between women and men. METHODS: Between 1999 and 2001, 500 consecutive patients at the Wuppertal Heart Centre were treated with PCI after acute STEMI. A long-term follow-up (up to 7 years) was achieved in 97% of the patients. RESULTS: In comparison to men, women were 7 years older (65 +/- 12 vs. 58 +/- 11) and had significantly more diabetes mellitus. The time between onset of symptoms and intervention tended to be longer in women than men. There was no difference in 30-day mortality (8.9% vs. 6.6%), cardiac late mortality (3.6% vs. 3.2%), and long-term cardiac overall mortality up to 7 years (12.1% vs. 9.6%). Stepwise regression analysis did not identify female gender as an independent predictor of late mortality. The quality of life was comparable. CONCLUSIONS: There was no gender-related difference in the long-term outcome if patients were sytematically treated with PCI in STEMI. PCI in STEMI has a long-lasting positive effect in women and should, therefore, be considered the treatment of choice for women with acute myocardial infarction.

Comparison of usefulness of heart-type fatty acid binding protein versus cardiac troponin T for diagnosis of acute myocardial infarction.

We aimed to assess the additive diagnostic value of measuring the serum levels of soluble human heart-type fatty acid binding protein (H-FABP) in the early diagnosis of acute myocardial infarction (AMI) in unselected patients with chest pain. A total of 97 consecutive patients with acute ischemic-type chest pain were prospectively enrolled and classified according to the American Heart Association/American College of Cardiology guidelines. The test characteristics of H-FABP and cardiac troponin T serum levels at admission revealed a greater sensitivity of H-FABP in the first 4 hours of symptoms (86% vs 42%, p <0.05). Combining H-FABP and cardiac troponin T also improved the sensitivity in the detection of AMI (97% vs 71%, p <0.05) but demonstrated a greater misclassification rate (25% vs 9%, p <0.05). The specificity of H-FABP was poor (65%, 95% confidence interval 58% to 71%). Receiver operating characteristics revealed a poor performance of H-FABP in patients with non-ST-elevation myocardial infarction. Classification tree analysis demonstrated that an H-FABP-related improvement in the early definite rule-out of AMI (reduction of false-negative rate from 11% to 3%) was at the expense of an increase in the false-positive rate to 5%. In conclusion, measurement of H-FABP, in addition to cardiac troponin T, serum levels within the first 4 hours of symptoms improves the sensitivity and negative predictive value for the detection of AMI at the cost of test accuracy and precision, especially in patients with non-ST-elevation myocardial infarction.

Variation in the human soluble epoxide hydrolase gene and risk of restenosis after percutaneous coronary intervention.

BACKGROUND: Restenosis represents the major limiting factor for the long-term efficacy of percutaneous coronary intervention (PCI). Several genetic factors involved in the regulation of the vascular system have been described to play a role in the pathogenesis of restenosis. We investigated whether the EPHX2 K55R polymorphism, previously linked to significantly higher risk for coronary heart disease (CHD), was associated with the occurrence of restenosis after PCI. The association with incident CHD should have been confirmed and a potential correlation of the EPHX2 K55R variant to an increased risk of hypertension was analysed. METHODS: An overall cohort of 706 patients was studied: This cohort comprised of 435 CHD patients who had undergone successful PCI. Follow-up coronary angiography in all patients was performed 6 months after intervention. Another 271 patients in whom CHD had been excluded by coronary angiography served as controls. From each patient EDTA-blood was drawn at the baseline ward round. Genomic DNA was extracted from these samples and genotyping was performed by real-time PCR and subsequent melting curve analysis. RESULTS: In CHD patients 6 month follow-up coronary angiography revealed a restenosis rate of 29.4%, classified as late lumen loss as well as lumen re-narrowing >or= 50%.Statistical analysis showed an equal genotype distribution in restenosis patients and non-restenosis patients (A/A 82.0% and A/G + G/G 18.0% versus A/A 82.1% and A/G + G/G 17.9%). Moreover, neither a significant difference in the genotype distribution of CHD patients and controls nor an association with increased risk of hypertension was found. CONCLUSION: The results of the present study indicate that the EPHX2 K55R polymorphism is not associated with restenosis after PCI, with incidence of CHD, or with an increased risk of hypertension and therefore, can not serve as a predictor for risk of CHD or restenosis after PCI.

Use of a pigtail catheter to engage a difficult internal mammary artery.

Increasing use of bilateral internal mammary arteries for coronary surgery will increase the number of interventions in these grafts. Such interventions may be technically challenging because of often tortuous and angulated vessels. We describe a technique to intubate an acutely angulated right internal mammary artery that was inaccessible with conventional catheters.