Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE).

OBJECTIVE: To assess the safety and local recurrence-free survival in patients after cryoablation for treatment of pulmonary metastases. METHODS: This multicenter, prospective, single-arm, phase 2 study included 128 patients with 224 lung metastases treated with percutaneous cryoablation, with 12 and 24 months of follow-up. The patients were enrolled on the basis of the outlined key inclusion criteria, which include one to six metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm. Time to progression of the index tumor(s), metastatic disease, and overall survival rates were estimated using the Kaplan-Meier method. Complications were captured for 30 days after the procedure, and changes in performance status and quality of life were also evaluated. RESULTS: Median size of metastases was 1.0 plus or minus 0.6 cm (0.2-4.5) with a median number of tumors of 1.0 plus or minus 1.2 cm (one to six). Local recurrence-free response (local tumor efficacy) of the treated tumor was 172 of 202 (85.1%) at 12 months and 139 of 180 (77.2%) at 24 months after the initial treatment. After a second cryoablation treatment for recurrent tumor, secondary local recurrence-free response (local tumor efficacy) was 184 of 202 (91.1%) at 12 months and 152 of 180 (84.4%) at 24 months. Kaplan-Meier estimates of 12- and 24-month overall survival rates were 97.6% (95% confidence interval: 92.6-99.2) and 86.6% (95% confidence interval: 78.7-91.7), respectively. Rate of pneumothorax that required pleural catheter placement was 26% (44/169). There were eight grade 3 complication events in 169 procedures (4.7%) and one (0.6%) grade 4 event. CONCLUSION: Percutaneous cryoablation is a safe and effective treatment for pulmonary metastases.

Power injection of microcatheters: an in vitro comparison.

PURPOSE: To determine the tolerance of 0.021-inch and 0.027-inch microcatheters to power injection in an in vitro flow model. MATERIALS AND METHODS: Twenty-four microcatheters (0.021-inch, n = 13; 0.027-inch, n = 11) were injected with iothalamate meglumine through a flow model with use of a power injector and high-pressure tubing. Catheters used included Rebar (0.021-inch, n = 4; 0.027-inch, n = 4), Transit (0.021-inch, n = 3; 0.027-inch, n = 3), Renegade (0.021-inch, n = 4; 0.027-inch, n = 4), and Renegade STC-18 (0.021-inch, n = 2) models. Through the 0.021-inch microcatheters, 5-second injections were performed at an initial rate of 0.7 mL/sec. Injection rates were increased by 0.5 mL/sec and the process was repeated until the pressure approached 1,000 psi or catheter breakage occurred. A similar process was repeated for the 0.027-inch catheters starting at a rate of 3.4 mL/sec. RESULTS: The 0.021-inch catheters were injected 303 times and the 0.027-inch catheters were injected 210 times. Three catheter failures occurred, with all breaks occurring at pressures greater than manufacturer recommendations. The 0.027-inch catheters as a group tolerated significantly higher injection rates than the 0.021-inch catheters. Of the 0.021-inch catheters, the STC-18 also provided superior maximum flow and volume compared with the Renegade catheter. The Rebar catheter tolerated significantly lower maximum injection rates and volumes than the other 0.027-inch catheters. CONCLUSIONS: The majority of microcatheters can be power-injected in vitro at pressures far greater than manufacturer recommendations. When fractures occur, they are near the hub of the catheter. Significantly greater rates of injection are possible through 0.027-inch catheters.