Male-female differences in thoracic aortic diameters at presentation of acute type A aortic dissection.

Background: Acute type A aortic dissection (ATAAD) is a highly lethal event, associated with aortic dilatation. It is not well known if patient height, weight or sex impact the thoracic aortic diameter (TAA) at ATAAD. The study aim was to identify male-female differences in TAA at ATAAD presentation. Methods: This retrospective cross-sectional study analysed all adult patients who presented with ATAAD between 2007 and 2017 in two tertiary care centres and underwent contrast enhanced computed tomography (CTA) before surgery. Absolute aortic diameters were measured at the sinus of Valsalva (SoV), ascending (AA) and descending thoracic aorta (DA) using double oblique reconstruction, and indexed for body surface area (ASI) and height (AHI). Z-scores were calculated using the Campens formula. Results: In total, 59 % (181/308) of ATAAD patients had CT-scans eligible for measurements, with 82 female and 99 male patients. Females were significantly older than males (65.5 ± 12.4 years versus 60.3 ± 2.3, p = 0.024). Female patients had larger absolute AA diameters than male patients (51.0 mm [47.0-57.0] versus 49.0 mm [45.0-53.0], p = 0.023), and larger ASI and AHI at all three levels. Z-scores for the SoV and AA were significantly higher for female patients (2.99 ± 1.66 versus 1.34 ± 1.77, p < 0.001 and 5.27 [4.38-6.26] versus 4.06 [3.14-5.02], p < 0.001). After adjustment for important clinical factors, female sex remained associated with greater maximal TAA (p = 0.019). Conclusion: Female ATAAD patients had larger absolute ascending aortic diameters than males, implying a distinct timing in disease presentation or selection bias. Translational studies on the aortic wall and studies on growth patterns should further elucidate these sex differences.

[How does a new medicine reach the patient?] / Hoe bereikt een nieuw geneesmiddel de patiënt?

The Medicines Evaluation Board (MEB) grants market authorisation for medicinal products in the Netherlands. The European Medicines Agency (EMA) coordinates the evaluation and safeguarding of medicinal products in the European Union. The core task of the MEB is to evaluate the quality of every medicinal product for which marketing authorisation is applied for by the manufacturer, and to assess the risk - efficacy balance of the product concerned. There are three different procedures that a manufacturer can follow: (a) the national procedure; (b) the decentralised procedure or mutual recognition procedure; (c) the centralised procedure. After marketing authorisation has been granted, the MEB ensures pharmacovigilance in cooperation with partners such as the Netherlands Pharmacovigilance Centre (Lareb). The MEB determines the text of the package leaflet, the packaging and the Summary of Product Characteristics (SmPC). The MEB checks the warnings that are sent out by manufacturers if important new information about a medicinal product becomes available.

Intermittent warm blood versus cold crystalloid cardioplegia for myocardial protection: a propensity score-matched analysis of 12-year single-center experience.

OBJECTIVES: This study analyzes the efficacy in myocardial protection of two types of cardioplegia solutions, namely, blood and crystalloid cardioplegia, both given intermittently in patients undergoing coronary artery bypass grafting (CABG). METHODS: Adult patients undergoing primary isolated coronary artery bypass grafting between January 1998 and January 2011 with cardiopulmonary bypass, using either blood or crystalloid cardioplegia, were identified in our database. Propensity score matching was performed to create comparable patient groups. Multivariate logistic regression analysis was performed to identify independent risk factors for perioperative myocardial damage. The primary endpoint of the study was the maximum creatine kinase-MB (CK-MB) value within 5 days postoperatively with a cut-off point of 100 U/L. Early mortality and perioperative low cardiac output syndrome in both groups were compared. RESULTS: The study included 7138 CABG patients: 3369 patients using crystalloid cardioplegia and 3769 using blood cardioplegia. After propensity score matching, 2585 patients per study group remained for the analysis. Wilcoxon signed-rank test revealed significantly higher CK-MB levels in patients operated with the use of blood cardioplegia. Multivariate regression analysis identified blood cardioplegia as an independent risk factor for elevated CK-MB levels. However, it was associated with lower aspartate aminotransferase (AST) levels. The type of cardioplegia had no influence on early mortality, postoperative low cardiac output syndrome or intensive care unit stay. CONCLUSIONS: Blood cardioplegia was identified as an independent risk factor for elevated levels of CK-MB after CABG, but was associated with lower AST levels. The authors conclude that the type of cardioplegia had no significant influence on clinical outcome.

Clinical outcome of the PAS-Port® proximal anastomosis system in off-pump coronary artery bypass grafting in 201 patients.

AIM: The PAS-Port® Proximal Anastomosis System (Cardica, Inc, Redwood City, CA, USA) has been used worldwide since March 2003. The objective of the present study was to evaluate the clinical outcome of the PAS-Port® Proximal Anastomosis System. METHODS: All the patients who underwent off-pump coronary artery bypass grafting in the Catharina Hospital Eindhoven between August 2006 and April 2010 were included in a non-randomized retrospective case-control study, if they had at least one proximal vein graft anastomosis. Study end-points consisted of overall survival, coronary reintervention and postoperative stroke. RESULTS: The study included 312 patients (201 cases, 111 controls). After 36 months of follow-up there was no difference in survival between cases and controls (92.2% vs. 93.7%, P=0.52). No significant difference could be detected between cases and controls with respect to overall coronary reintervention-free survival (93% vs. 96.4%, P=0.20) and freedom from coronary reintervention due to proximal vein graft failure (98% vs. 100% P=0.14). The use of the PAS-Port system could not be identified as an independent risk factor of coronary reintervention (p=0.21). Postoperative stroke rates of cases and controls (2% vs. 0.9%, P=0.42) were comparable. CONCLUSION: The clinical outcomes in patients treated with the PAS-Port® Proximal Anastomosis System were satisfactory compared with those treated with the conventional hand-sewing technique. The use of the PAS-Port system was not associated with higher adverse outcome in terms of overall survival, stroke, coronary reintervention-free survival and freedom from reintervention due to proximal vein graft failure.