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Abstract: Objectives: We sought to determine the incidence of femoral pseudoaneurysm (FPA) following cardiac catheterization, identify the risk factors for FPA and factors influencing therapeutic strategy. Methods: 11,992 consecutive patients who underwent cardiac catheterization via femoral artery were studied over a period of four years in one University Hospital. Our prospective case control group analysis registered patients who developed FPA after the procedure. Patient-related factors, procedure related factors and peri-procedure treatment were compared between the two groups. Results: 76 FPA were diagnosed over the study period accounting for a global incidence of 0.6% procedures. By univariate analysis, interventional procedure (p <0.01), rhythmologic procedure (p =0.03), sheath≥6F (p =0.04) and left groin puncture (p <0.001) were FPA risk factors. By multivariate analysis, interventional procedure (adjusted odds ratio [OR]=1.99; 95% confidence interval [CI]1.14–3.44 p =0.01) and left groin puncture (OR=4.65; 95% CI, 1.78–12.1 p =0.001) are independent predictive factors of FPA. FPA thrombosis was obtained by ultrasound guided compression (UGC) in 71% of the cases. By univariate analysis, PFA diameter larger than 4 cm (p <0.001), the use of anticoagulation (p <0.01) or GPIIbIIIa inhibitors (p =0.001) and UGC under anticoagulation (p =0.01) are predictive factors of need for FPA surgical repair. By multivariate analysis, FPA diameter>4 cm and use of GPIIbIIIa inhibitors are independent predictive factors of FPA''s surgical treatment. Superficial femoral puncture was predictive of successful UGC both by uni and multivariate analysis. Conclusions: Our study shows that FPA occurrence is mainly due to by procedure-related factors. FPA size, level of puncture and the use of GPIIbIIIa inhibitors are independent predictive factors of need for surgical therapy. [Copyright &y& Elsevier]

Implantable cardioverter-defibrillator (ICD) malfunctions sometimes need recall. Despite the increasing number of device implantation, ICD recalls and advisories' impacts have been little studied. The aim of this study was to determine the rate of ICD generator advisory in our center and to examine its clinical and financial implication. We analyzed weekly Food and Drug Administration (FDA) Enforcement Reports issued between January 2000 and December 2008 to identify all advisories involving ICD generators and leads. We performed a retrospective analysis of all implanted patients affected by an advisory in our Cardiology department. During the 8 years of the study period, 13 advisories were issued for generators and one for leads, leading to a total number of 278 of 1,051 (26.4%) device with recall alerts, divided into 196 generator failures and 82 lead failures. Premature generator replacement was performed in 11 patients, whereas nine patients underwent lead replacement. There was no major complications attributable to advisory device replacement, and minor complications occurred only in one patient (lead extraction failure). Recalls accounted for 593 extra outpatient visits with a mean number of 2.20 ± 2.19 per patient. The total estimated cost of the device advisories in our population was 334,528 €. ICD recalls and safety alerts frequently occur in ICD recipients and tend to increase in number and rate. Although potentially serious, they do not appear to be associated with substantial complications. Financial implications are important. (PACE 2011; 96-103) [ABSTRACT FROM AUTHOR]