Case Study: Cryoablation of Fibroadenoma Cryoablation of benign and malignant tumors of the prostate, lung and kidney has been reported in the literature for decades. Cryoablation of fibroadenomas (FAs) has been available since 1999, with the most recent generation of the technology gaining acceptance as a preferable in-office treatment option for patients with painful, palpable or growing FAs.
Clinical Case Summary: 30 yr old female presented with a painful, palpable Fibroadenoma (FA) in her left breast (5 O’clock, 5 cm FN) measuring 2.8 cm x 2.3 cm x 1.8 cm. A core biopsy confirmed FA diagnosis. The patient requested information about her treatment options. Observation of the benign tumor was rejected because she no longer wanted to endure the monthly pain and tenderness at the fibroadenoma site. She also did not want surgical excision because of the associated cost and time, potential scarring, and changes in the shape of her breast. Instead, she chose cryoablation with IceSense3™ because it is minimally invasive, maintains her breast cosmesis, is a short in-office procedure without systemic anesthetics for procedural pain control, and is less expensive than surgery. Procedure Summary: The IceSense3™ cryoprobe was inserted and an 8-minute treatment algorithm was initiated based on the anticipated time it would take to create an ice ball to engulf the FA (Table 1). The pictures demonstrate the lesion’s max length, width and height (a); the ice ball, as it is engulfing the FA in the longitudinal and transverse views (b, c); and the ice ball size (ablation zone) at the end of the procedure (d). Outcomes/Follow-up: Short duration spot pressure was applied to the insertion site after probe removal. A wound closure adhesive was applied and, the patient was instructed to wear a comfortable bra for one week post procedure. The patient tolerated the procedure well, and no immediate complications were encountered. Patient reported mild soreness of the breast, similar to the recent core biopsy procedure she had prior to cryoablation. This is an expected finding. During a phone interview the following morning, the patient indicated no complaints, and the mild soreness she reported had begun to subside. She was happy as to how quick and relatively painless the procedure was. She had already returned to work. The patient was recommended to return for a surveillance ultrasound in a year’s time and to expect the cyclic breast pain associated with her FA to be minimal to nonexistent. The involution of the ablation zone will continue for at least a year; the size and palpability of the affected area should improve over time as well.
Technology/Procedure and Outcomes: IceSense3™, the most recent generation of the technology, utilizes liquid nitrogen circulating thru a small cryoprobe. This process allows for a nominal 3 mm skin incision and a very short treatment time adjusted based on real time monitoring on ultrasound (See table 1). The technology also allows for targeted cryoablation, minimizing the ablation of the surrounding healthy breast tissue. The result is an ablation zone consistent with the size of the original fibroadenoma that immediately begins the involution process, and continues to involute/resorb over time. The involution time frame varies based on lesion size, patient age, health, and healing history. The literature reports that FAs less than 2 cm are non-palpable 86% of the time by 12 months (Kaufman 2005). Littrup (2004) reported that 89% of all FAs in his study, independent of original size, were non-palpable at 12 months. The CRYSTAL study (Hahn 2013) which reports data specific to the IceSense technology, stated the average volume of the ablation zone was reduced by 75% at 12 months, indicating the FA was destroyed and being reabsorbed. Liu, et al. (2011) described the average scar length for fibroadenoma surgical excision as 4.6 cm. Reimbursement Issues: As demonstrated in Table 2, the cost of IceSense3™ cryoablation is much less than its surgical counterpart. This cost reduction not only makes this procedure appealing to the patient but also to the referring institution and payers. Conclusion: When comparing the potential scar and breast deformity that occurs post-FA removal with excellent documented breast cosmesis associated with cryoablation (Kaufman 2005; Littrup 2004), the decision to offer cryoablation is self-evident. For those who want treatment for their symptomatic FAs, cryoablation is a safe, minimally invasive alternative to surgical excision.