in the two groups. Driveline infections were defined according to the International Society for Heart and Lung Transplantation Consensus statement. Groups were com- pared using chi-square, Fisher’s exact, Mann-Whitney, or t-tests, as appropriate. Kaplan-Meier curves were com- pared using the log-rank and Wilcoxon tests. Analyses were performed with SAS 9.2 (SAS Institute, Cary, NC) and Stata 11 software (StataCorp, College Station, TX) We identified 16 patients who used the Utah foam-based technique and 47 who used the gauze technique. Patients were monitored for the duration of VAD support, but fol- low-up was truncated at 18 months for the purpose of this analysis because no patients with the Utah technique had more than 18 months of follow-up. Data for 3 caregivers in the foam group and 1 caregiver and 1 patient in the gauze group were not available. Baseline characteristics, infection, and satisfaction are reported in Table 1. Caregiver satisfac- tion was significantly higher in the Utah technique group (Table 1). As shown in Figure 1, we noted non-inferiority of the foam dressing technique to the gauze dressing in 18 months of follow-up in the 2 groups with comparable body mass index and duration of support, 2 factors that have previously been shown to increase the risk of driv- eline infection. 2,3 We observed good outcomes with both techniques, a finding that may empower clinical teams to offer the technique most suitable for an individual patient rather than relying exclusively on a single method within a program. Disclosure statement Dr Eckman has received research support and honoraria from Thoratec and honoraria from HeartWare. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose. No funding source was needed for this study. References 1. Gordon R, Quagliarello B, Lowy F. Ventricular assist device-related infections. Lancet Infect Dis 2006;6:426-37. 2. Zierer A, Melby SJ, Voeller RK, et al. Late-onset driveline infections: the Achilles’ heel of prolonged left ventricular assist device support. Ann Thorac Surg 2007;84:515-20. 3. Raymond AL, Kfoury AG, Bishop CJ, et al. Obesity and left ventricular assist device driveline exit site infection. ASAIO J 2010;56:57-60. Intra-operative fitting study of the PediPump ventricular assist device Diyar Saeed, MD, a Kiyotaka Fukamachi, MD, PhD, a and Brian W. Duncan, MD, MBA b a Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio and b Department of Pediatric and Congenital Heart Surgery, Children’s Hospital, Cleveland Clinic, Cleveland, Ohio To the Editor: Issues related to anatomic fit of implantable ventricular assist devices (VADs) are particularly important during the development of devices intended for implantation in pedi- atric patients or in patients with a small body surface area (BSA) of 1.5 m 2 . 1 Anatomic fit assessment using animal models or human cadavers is limited by cost, time and test subject availability. We are developing the PediPump, a miniature VAD, designed specifically for pediatric applications. 2 The Pe- diPump, 10 mm in diameter and 70 mm in length, offers the potential of being implantable in small children. To assess fitting of the PediPump VAD, we aimed to evaluate intra- operative device fitting and determine optimal placement strategies in pediatric patients at the time of routine cardiac surgical procedures. Our study was approved by the institutional review board of the Cleveland Clinic. Device fitting was performed using a sterile silicone pump model in patients undergoing elec- tive cardiac surgical procedures (Figure 1). Intra-operative measurements included the diameter of the major vessels and their shortest distances to the sternum and diaphragm and the clearances between the left and right ventricular surfaces and the sternum and the left ventricular apex to the ascending aorta dimension. Device fit was evaluated for 0.00 0.25 0.50 0.75 1.00 Probability of no infection 0 200 400 600 Time from implant (days) Foam Gauze Figure 1 Kaplan-Meier curve shows time to infection for the foam group (solid line) and gauze group (dashed line) during 540 days of follow-up. Log-rank p = 0.58; Wilcoxon p = 0.54. Figure 1 PediPump silicon model and outflow graft. 109 Comments and Opinions