Radiosurgery with the world's first fully robotized Leksell Gamma Knife PerfeXion in clinical use: a 200-patient prospective, randomized, controlled comparison with the Gamma Knife 4C.

OBJECTIVE: The world's first Leksell Gamma Knife PerfeXion (Elekta Instrument AB, Stockholm, Sweden) for radiosurgery of the head and neck became operational at Timone University Hospital in Marseille on July 10, 2006. To allow strict evaluation of the capabilities, advantages, disadvantages, and limitations of this new technology, patients were enrolled in a prospective, randomized trial. METHODS: In 66 working days, between July 10 and December 20, 2006, 363 patients were treated by gamma knife surgery at Timone University Hospital, Marseille. Of these patients, 200 were eligible for the comparative prospective study (inclusion criteria were informed consent obtained, tumor or vascular indication, and no previous radiosurgery or radiotherapy). In accordance with the blinded randomization process, 100 patients were treated with the Leksell Gamma Knife 4C (Elekta Instrument AB) and Gamma Knife 100 (Elekta Instrument AB) with the Leksell Gamma Knife PerfeXion. Dose planning parameters, dosimetry measurements on the patient's body, workflow, patient comfort, quality assurance procedure, and a series of other treatment-related parameters were systematically and prospectively evaluated in both arms of the trial. RESULTS: No technical failure of the treatment procedure was encountered. The new dose-planning system led to the use of composite shots in 39.4% of the patients. The median number of different collimator sizes used was larger with the PerfeXion than with the 4C (2 and 1, respectively). The mean number of isocenters used was lower (10.67 and 13.08, respectively). The median total treatment time was significantly shorter with the PerfeXion (40 and 60 minutes, respectively), but there was no significant difference in the median radiation time (34.02 and 33.40 minutes, respectively). The procedure was performed using only a single run in 98.99% of the PerfeXion cases and in 42% of the 4C cases. Collision risk on the 4C forced us to change the frame gamma angle for at least 1 shot in 24% of the patients and led to treatment in manual mode for at least 1 shot in 21% of the patients. Collision risk requiring technical adaptation did not occur with the PerfeXion. In 1 patient treated with the PerfeXion, the system required a direct collision check. In terms of dose to structures outside the target area, the PerfeXion delivers 8.2 times less to the vertex, 10 times less to the thyroid, 12.9 times less to the sternum, and 15 times less to the gonads. CONCLUSION: Our prospective study indicates that procedures with the PerfeXion were collision-free, even with very eccentric lesions (e.g., multiple metastases). The duration of the surgical procedure, the amount of time required for nurse, physicist, and physician intervention on the machine, and the duration of the quality assurance procedure were all shown to be dramatically reduced with the PerfeXion gamma knife. Patient protection is greatly improved with the PerfeXion. In our experience, the technological advances of the Leksell Gamma Knife PerfeXion will make a very significant contribution to future progress in head and neck radiosurgery.

Hearing preservation after gamma knife radiosurgery for vestibular schwannomas presenting with high-level hearing.

OBJECTIVE: The aim of this study was to evaluate long-term hearing preservation after gamma knife radiosurgery (GKS) for vestibular schwannomas in patients with initially normal or subnormal hearing (Gardner-Robertson Class 1) and to determine the predictive factors for functional hearing preservation. METHODS: Since July 1992, more than 2053 vestibular schwannomas have been treated by GKS and followed at the Timone University Hospital, Marseille. A minimum of 3 years of follow-up (range, 3-11 years; median, 48 months) is available for 74 patients (without neurofibromatosis Type 2 or previous surgery) with Gardner-Robertson Class 1 hearing. RESULTS: The average age of the patients was 47.5 years (range, 17-76 years). The number of tumors in Koos Stage I was 8, the average number in Stage II was 21, the average number in Stage III was 43, and the average number in Stage IV was 2. The median number of isocenters was 8 (range, 2-45), and the median marginal dose was 12 Gy (range, 9-13 Gy). At the time of the last follow-up evaluation, 78.4% of the patients had preserved functional hearing. Tumor control was achieved in 93% of the cases. The probability of preserving functional hearing was higher in patients who had an initial symptom other than hearing decrease (91.1%), in patients younger than 50 years (83.7%), and in those treated with a dose to the cochlea of less than 4 Gy (90.9%). CONCLUSION: This study shows that the probability of preserving functional hearing in the long term after GKS for patients presenting with unilateral vestibular schwannomas is very high. The positive predictive factors appear to be young age, an initial symptom other than hearing decrease, and a low dose to the cochlea.