Feasibility and Accuracy of a Novel Hands-Free Robotic System for Percutaneous Needle Insertion and Steering.

PURPOSE: To assess the performance and accuracy of CT-guided needle insertion for clinical biopsies using a novel, hands-free robotic system that balances accuracy with the duration of the procedure and radiation dose. MATERIALS AND METHODS: A prospective, multi-center study was conducted on 60 clinically indicated biopsies of abdominal lesions at two centers (Center 1, n=26; Center 2, n=34). CT datasets were obtained for planning and controlled placement of 17g and 18g needles using a patient-mounted, CT-guided robotic system with 5 degrees of freedom. Planning included target selection, skin entry point, and predetermined checkpoints where additional imaging was performed to permit stepwise correction of the needle trajectory. Success rate, needle tip-to-target distance, number of checkpoints used, number of trajectory corrections, procedure duration, and effective radiation dose were recorded and compared between centers. RESULTS: In 55 of 60 procedures (91.7%), the robot positioned the trocar needle successfully on target. In the remaining 5 patients, the procedure was manually performed by the operator due to technical failure (n=3) or patient-related factors (n=2). The average lesion size was 2.8 ± 1.7cm with a lesion depth from the skin of 8.7 ± 2.6cm, and there was no difference between centers. The overall accuracy (needle tip-to-target distance) was 1.71 ± 1.49 (range 0.05-7.20mm), with an accuracy of 2.06 ± 1.45 mm at Center 1 and 1.45 ± 1.52 mm at Center 2 (p=0.1358). Center 1 used significantly more checkpoints (4.96 ± 1.08) and performed target adjustments in 20 of 24 (83%) cases compared to Center 2 (2.77 ± 0.6 checkpoints and target adjustments in 13 of 31 cases, 42%) (p=0.0024). Accordingly, the steering duration from skin entry to the target varied between Centers 1 and 2; 13.1min ± 4.25min vs. 5.7min ± 2.7min, respectively (p <0.001). The average DLP for the entire procedure was 1147 ± 820 mGycm, with a slightly lower average at Center 2 (1031 ± 724 mGycm) compared to Center 1 (1297 ± 925 mGycm) (p=0.236). CONCLUSION: Accurate needle-targeting within an error of 2mm can be achieved in patients using a CT-guided robotic system. The variation in the number of checkpoints did not affect system accuracy but was related to shorter steering times and may contribute to a lower radiation dose. Accurate needle insertion using a hands-free CT-guided robotic system may facilitate difficult needle placement and enhance the performance of less-experienced interventionalists.

Can atorvastatin improve the response to sildenafil in men with erectile dysfunction not initially responsive to sildenafil? Hypothesis and pilot trial results.

BACKGROUND: Erectile dysfunction (ED) may be one manifestation of a generalized vascular disorder characterized by endothelial dysfunction. Statin drugs may improve endothelial function, even before altering the lipid profile. OBJECTIVE: We sought to determine whether the addition of a statin with sildenafil would improve ED in men who initially responded poorly to sildenafil. METHODS: Men with moderate-to-severe ED despite an adequate sildenafil trial were enrolled in this randomized, double-blind, placebo-controlled pilot study. ED was defined using a validated self-administered questionnaire as a score of

Percutaneous patent foramen ovale and atrial septal defect closure in adults: results and device comparison in 100 consecutive implants at a single center.

Closure of interatrial septal defects with percutaneous devices is increasingly common. However, the indications for closure and techniques for device implantation are diverse. We reviewed our first 100 consecutive implants to assess and compare the indications, results, complications, and evolution of techniques for percutaneous patent foramen ovale (PFO) and atrial septal defect (ASD) closure. The mean age of patients was 52 years and 70% were female. Paradoxical embolism was the predominant indication (94%) for PFO closure and significant left-to-right shunt was the most frequent indication (89%) for ASD closure. Implantation success was 94% with major complications in 3 patients (2.8%). Transesophageal echocardiography was utilized in the initial 27 procedures and then replaced by intracardiac echocardiography in subsequent ones, with an associated reduction in procedure and physician time. During 6 months of follow-up, 3 patients were readmitted for atrial arrhythmias (2 patients) and an MRI-negative neurologic event (1 patient). Echocardiography at 6 months in 83% of the PFO patients revealed moderate and severe positive contrast studies for right-to-left shunting in one third of patients, with differences between devices and insertion techniques. This single-center experience with percutaneous device closure of PFO and ASD in adults demonstrates excellent results with few complications.