Cryoablation

Joan Lunden Interviews Dr. Holmes about Cryoablation

What is cryoablation?

Cryoablation is a groundbreaking new treatment for breast tumor freezing. Cryoablation has been used for many years on liver, skin, and cervical cancers, as well as benign tumors of the breast. It is not until recently, however, that cryoablation has been adapted to treat breast cancer. The results of a national study co-authored by Dr. Holmes found cryoablation to be most effective at killing invasive breast cancers measuring 2 cm or smaller.  However, certain patients may undergo cryoablation of larger tumors if multiple ablations are used to treat the entire tumor and surrounding margins.   

How is cryoablation performed?

The cryoablation procedure is similar to having an ultrasound-guided needle biopsy of the breast. The procedure is performed in the office with the patient awake and comfortable. First, ultrasound of the breast is performed to identify the location of the cancer. Next, local anesthetic is injected into the skin and into the interior of the breast. A small (3 mm) skin incision is made followed by the insertion of a needle-like instrument called a cryoprobe through the center of the breast cancer using ultrasound to guide the way. The cryoablation system is then turned on and liquid nitrogen circulates within the cryoprobe to freeze the cancer and a surrounding rim of normal tissue to a temperature of minus 20 Celsius. The freezing process takes approximately 30 minutes to complete, and the entire procedure typically takes about 1 hour from start to finish. 

For detailed information about cryoablation and to observe a video of Dr. Holmes performing an actual cryoablation procedure, visit www.cryoablation.com or YouTube.

View Video of Cryoablation Procedure 

Who is eligible to receive cryoablation?

Cryoablation may be obtained under the following circumstances:

The DCIS Cryoablation Trial: Nearly all invasive breast cancers arise out of ductal carcinoma in situ (DCIS), which is commonly called pre-invasive breast cancer or non-invasive breast cancer. If not for the risk of invasive cancer and its potential to metastasize, surgical removal of DCIS would be completely unnecessary. Cryoablation or tumor freezing is a minimally invasive office procedure that has the potential to replace surgery as an invasive cancer prevention option for women with small areas of DCIS. In this study, cryoablation will provide a minimally invasive breast cancer treatment option for women with DCIS measuring 2 cm or less based on standard breast imaging (Ultrasound, Mammogram).  Breast MRI is recommended but optional. .

The DCIS Cryoablation Study is open to the following:

• Women Age 18 and older
• Have had a needle biopsy of the breast showing ductal carcinoma in situ and no evidence of invasive breast cancer
• Have ductal carcinoma in situ measuring 2.0 cm or less by mammogram and or breast MRI performed within 3 months of study enrollment
• Women willing to undergo placement of an ultrasound visible marker at the site of DCIS if the DCIS is not already ultrasound-visible
• Women willing to undergo mammography and a core needle biopsy of the cryoablation site 6 months after cryoablation.
• Women willing to obtain annual mammograms after cryoablation..

Patients will not be charged for the cryoablation procedure if their insurer does not pay for cryoablation procedure. All other standard breast procedures will be billed to your insurer.  Usual insurance deductibles may apply.

To find out more about the DCIS Cryoablation Trial, please visit: https://helenreybreastcancerfoundation.com/dcis-cryoablation-study

Off-Protocol: Women who are not eligible for the DCIS Cryoablation Trial can possibly receive cryoablation on a case-by-case basis. Possible “off-protocol” uses of cryoablation were summarized in a recent medical journal article authored by Dr. Holmes, titled “Breast Cancer Care During a Pandemic: An Opportune Time For Cryoablation?” To find out if you are eligible for cryoablation, you may schedule an office appointment with Dr. Holmes or submit your case online for consideration by following the instructions at the following link: https://www.cryoablation.com/submit-your-case-online.

Out of town patients seeking cryoablation will find the following link to be helpful: https://www.cryoablation.com/out-of-town-patients.

What you should know about payment for Cryoablation Procedures.

Whereas DCIS Cryoablation Study patients are not expected to pay for the cryoablation procedure, patients receiving cryoablation outside of the DCIS Cryoablation Study are billed directly for the cost of the procedure.

Except for DCIS Cryoablation Study patients, cryoablation is provided by Dr. Holmes on behalf of a separate company called Better Options Breast Care. Better Options Breast Care is not contracted with Medicare or any other health plans. Therefore, it is not possible to obtain pre-authorization for a cryoablation procedure. Patients are billed directly for the cost of the cryoablation procedure but are provided documentation which they may use to personally seek reimbursement from their health insurer. The cost of the cryoablation procedure depends on the size of the cancer and the number of cryoablations performed. To determine the estimated cost a cryoablation procedure, it is necessary to meeting with Dr. Holmes or submit your case online for review at https://www.cryoablation.com/submit-your-case-online.

What follow-up is needed after cryoablation?

To verify complete tumor kill, patients treated with cryoablation will generally be advised to undergo breast imaging and repeat needle biopsy of the cryoablation site six months after cryoablation to confirm that no living cancer cells remain. Surgical removal of cancer will be recommended only if living cancer cells are found. 

The following post-cryoablation follow-up protocol is recommended for most cryoablation patients.  Virtual doctor’s visits      are possible for out-of-town patients.

Is additional treatment required after cryoablation?

Cryoablation is intended to be a substitute for surgery, but it does not eliminate the need for radiation or anti-cancer medications. Therefore, you will be advised to consider radiation and anti-cancer medications if the characteristics of your breast cancer warrant them. In addition, whereas many patients that receive cryoablation may not require lymph node surgery, certain patients will still be advised to undergo lymph node surgery even if they received cryoablation of the breast.

For Learn More About Cryoablation, please visit www.cryoablation.com.