Clinical evaluation of a microwave device for treating axillary hyperhidrosis.

BACKGROUND: A third-generation microwave-based device has been developed to treat axillary hyperhidrosis by selectively heating the interface between the skin and underlying fat where the sweat glands reside. MATERIALS AND METHODS: Thirty-one (31) adults with primary axillary hyperhidrosis were enrolled. All subjects had one to three procedure sessions over a 6-month period to treat both axillae fully. Efficacy was assessed using the Hyperhidrosis Disease Severity Scale (HDSS), gravimetric weight of sweat, and the Dermatologic Life Quality Index (DLQI), a dermatology-specific quality-of-life scale. Subject safety was assessed at each visit. Subjects were followed for 12 months after all procedure sessions were complete. RESULTS: At the 12-month follow-up visit, 90.3% had HDSS scores of 1 or 2, 90.3% had at least a 50% reduction in axillary sweat from baseline, and 85.2% had a reduction of at least 5 points on the DLQI. All subjects experienced transient effects in the treatment area such as swelling, discomfort, and numbness. The most common adverse event (12 subjects) was the presence of altered sensation in the skin of the arm that resolved in all subjects. CONCLUSION: The device tested provided efficacious and durable treatment for axillary hyperhidrosis.

A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study.

BACKGROUND: Duration of effect and effectiveness limit current options for treating axillary hyperhidrosis. A new microwave procedure for treatment of axillary hyperhidrosis has been tested. STUDY DESIGN/MATERIALS AND METHODS: Adults with primary axillary hyperhidrosis were enrolled in a randomized, sham-controlled, blinded study. Subjects were required to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 and baseline sweat production greater than 50 mg/5 min. Procedures were administered using a proprietary microwave energy device that isolates and heats target tissue. Responders were defined as subjects reporting a HDSS score of 1 or 2. Subjects were followed for 6 months (sham group) or 12 months (active group). RESULTS: Thirty days after treatment, the active group had a responder rate of 89% (72/81), and the sham group had a responder rate of 54% (21/39) (P < .001). Treatment efficacy was stable from 3 months (74%) to 12 months (69%), when follow-up ended. Adverse events were generally mild, and all but one resolved over time. CONCLUSIONS: The procedure demonstrated statistically significant, long-term efficacy in sweat reduction. As with any new procedure, findings from this first investigational device study identified optimization strategies for the future.

Microwave thermolysis of sweat glands.

BACKGROUND AND OBJECTIVES: Hyperhidrosis is a condition that affects a large percentage of the population and has a significant impact on peoples' lives. This report presents a technical overview of a new noninvasive, microwave-based device for creating thermolysis of sweat glands. The fundamental principles of operation of the device are presented, as well as the design and optimization of the device to target the region where the sweat glands reside. MATERIALS AND METHODS: An applicator was designed that consists of an array of four waveguide antennas, a cooling system, and a vacuum acquisition system. Initially, the performance of the antenna array was optimized via computer simulation such that microwave absorption was maximized near the dermal/hypodermal interface. Subsequently, hardware was implemented and utilized in pre-clinical testing on a porcine model to optimize the thermal performance and analyze the ability of the system to create thermally affected zones of varying size yet centered on the target region. RESULTS: Computer simulation results demonstrated absorption profiles at a frequency of 5.8 GHz that had low amounts of absorption at the epidermis and maximal absorption at the dermal/hypodermal interface. The targeted zone was shown to be largely independent of skin thickness. Gross pathological and histological response from pre-clinical testing demonstrated the ability to generate thermally affected zones in the desired target region while providing protection to the upper skin layers. CONCLUSIONS: The results demonstrate that microwave technology is well suited for targeting sweat glands while allowing for protection of both the upper skin layers and the structures beneath the subcutaneous fat. Promising initial results from simulation and pre-clinical testing demonstrate the potential of the device as a noninvasive solution for sweat gland thermolysis.

Computer-aided detection in diagnostic mammography: detection of clinically unsuspected cancers.

OBJECTIVE: We had two objectives: to determine the percentage of women presenting with clinical findings whose diagnostic mammogram led to detection of a breast cancer at a site distant from the original clinical complaint and to assess the performance of computer-aided detection (CAD) on diagnostic mammography. MATERIALS AND METHODS: Three institutions contributed consecutive cases in which a mammogram was obtained to evaluate a clinical finding, after which a histologic diagnosis of breast cancer was made. Clinical data and the mammograms were reviewed to determine the nature of the clinical findings and to document the location and characteristics of 212 biopsy-proven cancers in 197 patients who met the study criteria. Standard four-view breast mammograms were then analyzed by a CAD system. RESULTS: The most common clinical finding was a palpable mass (90%, 177/197), with nipple discharge (5%, 9/197), focal tenderness or pain (2%, 5/197), and miscellaneous complaints (3%, 6/197) also noted. Two separate cancers were found in 7.6% (15/197) of the cases. In another 7.6% (15/197) of the cases, the single diagnosed cancer was not at the location of the specific clinical finding. The CAD system correctly marked 87% (26/30) of those cancers that were clinically unsuspected (i.e., not at the location of the clinical finding). CONCLUSION: Breast cancers occurred at locations other than the site of the presenting clinical finding in 15% (30/197) of patients undergoing diagnostic mammography in whom a cancer was detected. CAD identified 87% of these incidentally detected cancers and may therefore be useful as a detection aid to the radiologist when interpreting diagnostic mammograms.

Computer-aided detection output on 172 subtle findings on normal mammograms previously obtained in women with breast cancer detected at follow-up screening mammography.

PURPOSE: To evaluate, by using a computer-aided detection (CAD) program, the nonspecific findings on normal screening mammograms obtained in women in whom breast cancer was later detected at follow-up screening mammography. MATERIALS AND METHODS: Four hundred ninety-three mammogram pairs-an initial negative screening mammogram and a subsequently obtained screening mammogram showing cancer-were collected. The mean interval between examinations was 14.6 months. In 169 cases, in which 172 cancers were later depicted, findings on the initial mammogram were subtle enough that either none or only one or two of five blinded radiologists recommended screening recall. On the initial negative mammograms, of the 172 areas where cancer later developed, 137 (80%) had subtle nonspecific findings and were retrospectively judged as having a benign or normal appearance. The mammograms with these subtle findings were evaluated with a commercially available CAD program, and the numbers of CAD marks on these nonspecific findings were analyzed. RESULTS: Of the 172 cancers, 129 (75%) were invasive and 43 (25%) were ductal carcinoma in situ. The CAD program marked 72 (42%) of the 172 findings that subsequently developed into cancer: 24 (29%) of 82 findings recalled by none, 25 (49%) of 51 findings recalled by one, and 23 (59%) of 39 findings recalled by two of the five radiologists. Among the 137 areas with nonspecific normal or benign findings, 41 (30%) areas where cancer subsequently developed were marked by the CAD program. CONCLUSION: A subset of cancers have perceptible but nonspecific mammographic findings that may be marked by a CAD program, even when the findings do not warrant recall as judged at blinded and unblinded radiologist review. The authors believe failure to act on such nonspecific but CAD-marked findings prospectively does not constitute interpretation below a reasonable standard of care.

Analysis of 172 subtle findings on prior normal mammograms in women with breast cancer detected at follow-up screening.

PURPOSE: To retrospectively review nonspecific findings on prior screening mammograms to determine what features were most often deemed normal or benign despite the development of breast cancer in the same location detected at follow-up screening. MATERIALS AND METHODS: Four hundred ninety-three pairs of consecutive mammographic findings were collected from 13 institutions, consisting of initial normal screening findings and a subsequent finding of cancer at screening (mean interval between examinations, 14.6 months). One designated radiologist reviewed each pair of mammograms and determined that 286 findings were judged visible at prior examination in locations where cancer later developed. Five blinded radiologists independently reviewed the prior findings in these 286 cases, identifying 169 mammograms (172 cancers) with findings so subtle that none or only one or two of the five radiologists recommended screening recall. Two unblinded radiologists reviewed the initial and subsequent findings and recorded descriptors and assessments for each finding and subjective factors influencing why, although the lesion was perceptible, it might have been undetected or not recalled. RESULTS: Of 172 cancers, 129 (75%) were invasive (112 T1 tumors and 17 T2 tumors or higher; median diameter, 10 mm), and 43 (25%) were ductal carcinoma in situ (median size, 10 mm). On the prior mammograms, 80% (137 of 172) of these cancers had subtle nonspecific findings where cancer later developed, and most were assessed as being normal or benign in appearance. CONCLUSION: There is a subset of cancers that display perceptible but nonspecific mammographic findings that do not warrant recall, as judged by both a majority of blinded radiologists and by unblinded reviewers. We believe failure to act on these nonspecific findings prospectively does not necessarily constitute interpretation below a reasonable standard of care.

Invasive lobular carcinoma of the breast: mammographic characteristics and computer-aided detection.

PURPOSE: To characterize the mammographic appearance of invasive lobular carcinoma in a large series of screening-detected consecutive breast cancers and to evaluate the ability of a computer-aided detection system to mark these carcinomas. MATERIALS AND METHODS: Investigators used the Breast Imaging Reporting and Data System lexicon to characterize lesions as part of a retrospective review of 90 screening mammographic examinations that led to biopsy-proved diagnosis of 94 invasive lobular carcinoma lesions. The 40 available prior mammographic examinations (obtained 9-24 months earlier) were also reviewed to characterize any visible findings. The results of a computer-aided detection analysis were compared with the images, and the sensitivity of the algorithm was calculated for correct detection of the lesions. RESULTS: Fifty-six (60%) of 94 lesions manifested as masses, of which 40 (71%) were described as irregular and spiculated; 20 (21%) of 94, as architectural distortions; and the remainder, 18 (20%), as either asymmetric densities or calcifications. On the screening mammograms showing biopsy-proved cancers, the sensitivity of the computer-aided detection system was 86 (91%) of 94 lesions. Thirty-one of the 40 prior mammograms showed retrospectively visible findings, and 24 (77%) of 31 were marked by the computer-aided detection system. CONCLUSION: Spiculated masses and architectural distortions are the predominant appearances of invasive lobular carcinoma, and a computer-aided detection system correctly marked a high percentage of invasive lobular carcinoma lesions.