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It sounds futuristic now, but Dr. Kambiz Dowlat hopes that one day interstitial laser therapy (ILT), currently an investigational method of percutaneous ablation that destroys small tumors in women with nonpalpable, mammographically-detected breast cancer, just might replace lumpectomy in selected patients. Last month, Dr. Dowlat discussed his research progress over the last decade or so at a session on minimally invasive breast surgery at the American College of Surgeons Annual Spring Meeting in New York City. The ILT device, for which Dr. Dowlat holds a patent (as well as being an owner and stockholder of Kelsey Inc.), uses laser energy delivered through a needle to heat the area around a tumor to 140° F, a temperature high enough to destroy all cancer cells. A second needle records that temperature. After diagnosis has been made initially by core needle biopsy, Dr. Dowlat's aim is to create a zone of necrosis around the tumor.
A pioneer in stereotactic breast biopsy, Dr. Dowlat has been testing the coagulation of early-stage breast cancers via ILT at Rush-Presbyterian St. Luke's Medical Center in Chicago, where the procedure is done under local anesthesia. Between 1994 and 2001, he performed ILT on 54 patients and included follow-up lumpectomy to be sure the tumors were totally destroyed. The overall complete tumor ablation rate was 70%. Before and after color Doppler U/S and PET scan provided confirmation of tumor destruction. Higher total destruction rates (93% and 100%) were achieved under steady state conditions in two groups of 14 patients. Dr. Dowlat concluded that ILT has the potential to replace lumpectomy in selected patients with well-defined parameters that include a lesion size limited to less than 1.5 cm.
For the present, though, a competing minimally invasive technology for nonsurgically removing breast tumors may be a bit closer to clinical application. An article in the April 2003 issue of General Surgery News concludes that radiofrequency ablation (RFA) seems to be the most promising of the new possibilities being investigated for removing the primary breast tumor without surgery. Preliminary results from the first multicenter study of RFA suggest its potential for successfully treating small invasive breast cancers. Primary investigator Eva Singletary, MD, of the University of Texas M.D. Anderson Cancer Center, Houston, observed a 93% ablation rate in 28 of 30 women undergoing RFA.
Using U/S guidance, surgeons placed an RF probe into the tumors. Ablation results from the high-frequency alternating current that activates ions in the tissue, causing frictional heating. In addition to this small study, papers in four leading scientific journals so far this year have described RFA as an important emerging treatment, according to General Surgery News.
For an article by Drs. Dowlat and Kenneth J. Bloom that gives details of the nonsurgical alternative of coagulation of early-stage breast cancers, visit the http://www.lasernews.net Web site.
Sentinel lymph node biopsy (SLNB) is being adopted as the new standard of care in biopsying most patients with breast cancereven for some women with ductal carcinoma in situ (DCIS) in whom there's high suspicion of invasion. That's true at least at all the major cancer centers, in the opinion of Dr. Kimberly J. Van Zee of Memorial Sloan-Kettering Cancer Center (MSKCC), who also spoke at the ACS's Annual Spring Meeting. SLNB, a surgical biopsy technique that can predict whether cancer has spread into the surrounding lymph nodes, is a potential alternative to the current standard practice of axillary lymph-node dissection (ALND). (Because ALND removes many more lymph nodes than SLNB, the former more often leads to complications like lymphedema, painful swelling, numbness, or loss of arm motion.)
Although a definitive answer on the merits of this less invasive approach awaits the outcome of ongoing clinical trials, Dr. Van Zee's own institution had called for making SLNB standard for early-stage cancer patients as far back as 1999, when they reported their first 500 cases. Now that Memorial Sloan-Kettering alone has completed more than 5,000 studies of SLNB, Dr. Van Zee, a surgical oncologist, updated the group on research findings there and elsewhere and addressed some current controversies.
"Two thirds of all women with breast cancer are pathologically node-negative and may not need axillary lymph node dissection," she said. Looking only at early invasive breast cancer patients (T1a and T1b), 85% to 95% don't need ALND, so SLNB allows the surgeon to identify those who need it.
Among the issues expected to be answered by clinical trials is whether to do a complete ALND when a sentinel lymph node result is positive. Also not every clinician is as experienced or practices the same technique for SLNB, she cautioned, adding that because the procedure has a learning curve, it's essential for the surgeon who's just starting out in doing the procedure to initially perform ALND as well .
A highly controversial issue has been the relative value of using isotope or blue dye to identify the SLN or nodes. (Most published series find that only about one third of women have just a single sentinel node15% of women may have four or morewhich leads to another dilemma of how many nodes to check.) MSKCC uses both isotope and dye. "If you're starting out, there's no reason not to use the belt-and-suspenders approach," she said.
SLNB false-negatives have been considered acceptably low, Dr. Van Zee noted, and most of these tumors will be palpable during surgery anyway. Nevertheless, surgeons should remove not just the sentinel node or nodes but any suspicious node also, she advised.
Whenever possible, doctors should be performing minimally invasive breast biopsies that can be done in an office to check for breast cancer, rather than traditional open surgical biopsies, a panel of breast cancer experts again urged at the ACS Annual Spring Meeting. Expanding on a previous paper published in the Journal of the American College of Surgeons that called for greater use of image-guided detection and treatment techniques, the panel was led by Melvin J. Silverstein, MD, of the Keck School of Medicine of the University of Southern California.
At the ACS's scientific session, the panel discussed several types of minimally invasive breast biopsies, but preferred minimally invasive vacuum-assisted breast biopsy. In this procedure, a needle or probe guided by ultrasound or x-ray is inserted once into a tiny incision in the breast and suspicious tissue is cut, vacuumed, and removed for analysis.
On the same page as Dr. Van Zee's earlier presentation when it comes to advocating sentinel lymph node biopsy, Dr. Silverstein's fellow panelist, Michael J. Edwards, MD, of the University of Arkansas for Medical Sciences College of Medicine recommended the continued adoption of SLNB whenever possible, to help avoid axillary lymph node dissection and the complications of major surgery.
Bronchopulmonary dysplasia, brain injury, and severe retinopathy of prematurity are each independent predictors of poor long-term outcomes in extremely low-birthweight (ELBW) infants, according to results from the International Trial of Indomethacin Prophylaxis in Preterms study.
Based on data on almost 1,000 infants born weighing between 500 and 999 g, researchers found that bronchopulmonary dysplasia increased the odds of death or neurosensory impairment at 18 months of age by almost two and a half times. Severe retinopathy of prematurity tripled the odds of a poor outcome. And brain injury almost quadrupled the odds.
Only 18% of children free of the three conditions experienced poor long-term outcomes, versus 42% of infants with one of the three problems, 62% of infants with two of the three, and 88% of infants with all three.
Schmidt B, Asztalos EV, Roberts RS, et al. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months. JAMA. 2003;289:1124-1129.
One in five women who deliver vaginally experience urinary incontinence, versus 16% of women who have cesarean sections and 10% of nulliparous women, according to a recent New England Journal of Medicine report.
Using a cohort of over 15,000 women from Norway, researchers found that those who deliver vaginally are also more likely than women who have C-S or those who are nulliparous to have moderate or severe incontinence, to have stress incontinence, and to have mixed-type incontinence. Those who receive C/S, however, have the highest incidence of the three groups of urge incontinence.
The accuracy of mammography varies greatly with patient age, breast density, and, to some extent, with use of hormone replacement therapy (HRT), according to a population-based study of over 300,000 women.
Researchers found the sensitivity and specificity of the breast cancer screening method to range from 62.9% and 89.1%, respectively, in women with extremely dense breasts to 87% and 96.9%, respectively, in women with very fatty breasts. Similarly, sensitivity and specificity ranged from 68.6% and 91.4%, respectively, in women 40 to 44 years of age to 83.3% and 94.4%, respectively, in women 80 to 89 years of age. HRT use indirectly decreases the accuracy of mammography by making breasts more dense.
Carney PA, Miglioretti DL, Yankaskas BC, et al. Individual and combined effects of age, breast density, and hormone replacement therapy use on the accuracy of screening mammography. Ann Intern Med. 2003;138:168-175.
Women who have naturally acquired immunity to cytomegalovirus (CMV) are 69% less likely to give birth to an infant with the infection than are women who are initially CMV seronegative, according to a cohort study of almost 3,500 multiparous women.
Researchers found that 3% of infants born to initially seronegative mothers had congenital CMV infection, while only 1% of those born to women with maternal antibodies acquired the infection.
The only other factor found to offer protection against congenital CMV infection was maternal age of at least 25 years.
A recent, large cohort study indicates it just may. Investigators from Spain and Sweden found an association between hormone replacement therapy and irritable bowel syndrome (IBS) similar to one observed in younger premenopausal women with endogenous estrogenic activity.
They identified 40,119 women aged 50 to 69 from the General Practice Research Database in UK with at least one prescription for HRT between 1994 and 1999. An age-matched cohort of 50,000 women who had never used HRT was taken from the same source. Women in both cohorts were followed to assess the risk of development of IBS. The authors performed a nested casecontrol analysis to evaluate the role of duration, route and regimen of HRT, and other risk factors for IBS. An IBS diagnosis was validated via a questionnaire sent to general practitioners (n=660).
In women who had never used HRT, the incidence of IBS per 1,000 person-years was 1.7, versus 3.8 among HRT users. An increased risk of IBS was present in both current and past users of HRT compared to nonusers, after adjustment for comorbidity and consultation patterns. The increased risk was irrespective of treatment duration, regimen, or route of administration. Restriction of the analysis to women older than age 55 produced virtually identical results.
Premature babies born mentally retarded don't always remain so, according to a recent study.
Researchers followed 296 infants born weighing between 600 and 1,250 g for up to 8 years. Using a test of verbal abilities and three different IQ tests, they found that half the children with scores in the mental retardation range (below 70) at age 3 had scores greater than 70 at age 8. Similarly, more than two thirds of the children with borderline scores at age 3 had scores in the normal range by age 8. IQ increased on average 5 points. Verbal test scores increased on average from 88 points at age 3 to 99 points at age 8.
Children who received early intervention such as speech therapy, those from two-parent households, and those with more highly educated mothers experienced the greatest improvements, while those born with bleeding in the brain experienced the least improvement.
OCs do not seem to increase weight or body fat among teenagers, but they do increase total serum cholesterol, serum low-density cholesterol (LDL-C), and serum triglyceride levels, according to 9 years of data on 66 non-Hispanic white young women.
The finding is in contrast to what has been observed in adult users of OCs, which is that low-dose OCs produce modest improvements in lipid profiles.
While the rates of change of total cholesterol, LDL-C, and triglycerides of the OC users were statistically different from those of the nonuser groups, the blood lipid profiles of the OC users did remain within normal range. The long-term effects of these alterations are unknown.
Estrogen therapy does not seem to protect postmenopausal women who have survived a myocardial infarction from future cardiac events, according to a randomized, placebo-controlled trial.
Researchers studied about 1,000 women between the ages of 50 and 69 who survived a first MI. The women received either 1 tablet of estradiol valerate (2 mg) or placebo daily for 2 years.
Although the rate of death from all causes was lower at 2 years in the unopposed estrogen group than in the placebo group (because of a slightly lower rate of cardiac deaths), the difference was not significant.
The authors of the study cautioned, however, that the trial lacked the power to unearth small differences in risk, and that compliance, particularly by the women in the active treatment arm, was poor, primarily because of bleeding.
Clinicians could be doing a better job of identifying postmenopausal women with coronary artery disease (CAD) who are at high risk for recurrent coronary events, and they are not making enough use of secondary prevention treatments in this population, asserts a recent study.
As part of the Heart and Estrogen/progestin Replacement (HERS) study, researchers identified 11 factors that when present in postmenopausal women with CAD, can increase the risk of recurrent coronary events up to sixfold, from 1.3% among women with none of the risk factors to 8.7% for women with five or more. Differing somewhat from the risk factors that have traditionally been used in primary prevention settings, these risk factors include: nonwhite ethnicity, lack of exercise, a deleterious cholesterol profile, several previous infarctions, renal dysfunction, diabetes, angina, heart failure, and uncontrolled hypertension.
The researchers also found that half or fewer of women with CAD are taking medications that help prevent future coronary events (i.e., aspirin, statins, diuretics, ß-blockers, ACE inhibitors, calcium antagonists, and folate). Women with five or more of the risk factors were the least likely to receive aspirin and other lipid- lowering therapies.
Although patients on estrogen alone can experience accelerated bone loss if they stop therapy, discontinuing alendronate or a combination of alendronate and estrogen doesn't have the same detrimental effects, according to a double-blind, placebo-controlled trial.
The study enrolled 244 postmenopausal, hysterectomized women aged 44 to 77 from 18 US centers. They were randomized to 2 years of therapy with alendronate (10 mg/d), conjugated estrogens (0.625 mg/d), alendronate and conjugated estrogens, or placebo. Bone mineral density (BMD) and biochemical markers were used to assess the effects of treatment. At the start of year 3, they were divided into five groups: placebo, combination therapy, alendronate, conjugated estrogen, and a portion of the population who had been taking either just estrogen, alendronate, or combination therapy who were switched to placebo.
In the women taking alendronate who were switched to placebo, BMD was 4.1% higher at the spine and 3.5% at the trochanter at the end of the third year, when compared with women taking estrogen alone who were switched to placebo. Similarly, BMD of women who were switched from combination therapy to placebo was 6.6% improved at the spine and 3.0% better at the trochanter, when compared to the estrogen alone group who were switched to placebo. The group of women who had remained on estrogen only experienced a 4.5% decrease at the spine and a 2.4% decrease at the trochanter when they discontinued it for the third year of the experiment. However, among the groups that discontinued active treatment after 3 years, no difference was seen in biochemical markers. The researchers also caution that the study was too small and too short to determine whether discontinuation of estrogen was associated with more fractures than discontinuation of the other treatments.
Greenspan SL, Emkey RD, Bone HG, et al. Significant differential effects of alendronate, estrogen, or combination therapy on the rate of bone loss after discontinuation of treatment of postmenopausal osteoporosis. Ann Intern Med. 2002;137:875-883.
Compared with women who never used hormone replacement therapy, current users did not seem to be protected from ischemic heart disease or myocardial infarction (MI), according to a Danish prospective observational study involving a cohort of nurses. The results are based on a trial of prevention of osteoporosis and atherosclerosis involving 23,178 members of the Danish Nurses' Association aged 45 and older, 19,898 of whom completed a comprehensive questionnaire in 1993.
Of the 13,084 postmenopausal women included in the analysis, 28% were current users of HRT, 14% were past users, and 58% were HRT-naïve. Median duration of use for current users was 6 years and for past users 2 years. Thirty-six percent used unopposed estrogen, 59% used 17ß-estradiol and norethisterone acetate, and the remainder (5%) were unsure of the regimen. Only 15 women (0.4%) used conjugated equine estrogens.
During the observation period, there were 971 deaths and 351 cases of ischemic heart disease. HRT did not offer any protection to women who were currently using HRT, when compared to women who had never used hormone therapy. And current users who also had diabetes were actually more likely to die, have ischemic heart disease, or an MI, when compared to those who never used HRT.
Babies at highest risk for sudden infant death syndromethose born extremely prematurelyare the ones parents most often allow to sleep on their stomachs, a recent study suggests.
Researchers found that while stomach-sleeping in general and among premature babies has declined, 17.5% of mothers reported putting their very small preemies to sleep on their stomachs 1 month after hospital discharge, versus 12.8% of mothers of larger babies.
Perhaps most interesting is that the prone position did not substantially increase the total sleep of the babies. It did, however, decrease the number of sleep transitions at 1 month of age, increase QT and JT intervals, and reduce heart rate variability, all of which increases the risk of SIDS.
The frequency of preeclampsia and gestational diabetes mellitus (DM) is higher in pregnancies complicated by polycystic ovarian syndrome (PCOS), according to a recent Norwegian study.
In this prospective cohort study, investigators looked at pregnancies and neonatal outcomes in 29 women with non-insulin-resistant PCOS, 23 women with insulin-resistant PCOS, and a control group of 355 women who conceived after assisted reproduction.
Among the women with PCOS, 11.5% developed hypertension, compared to only 0.3% in controls. Likewise, preeclampsia occurred in 13.5% of women with insulin-resistant PCOS, versus 7.0% among controls. (P<0.02). Gestational DM was also significantly more frequent in women with PCOS (7.7%) than in the controls (0.6%; P<0.01), but insulin resistance before pregnancy did not further increase the incidence of gestational GM.
An American Medical Association analysis identified six more states where increasing medical liability premiums are adversely affecting patient care. The number of states in crisis now totals 18.
According to the AMA analysis released in March, Arkansas, Connecticut, Illinois, Kentucky, Missouri, and North Carolina join Florida, Georgia, Mississippi, Nevada, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Washington and West Virginia as states in crisis.
The AMA, in a press release, said that the growing number of states in crisis emphasizes the need for Congress to pass medical liability reformspecifically, in the form of the HEALTH (Help Efficient Accessible, Low-Cost Timely Health Care) Act, or H.R.5.
The analysis looked at data showing physicians are retiring early, moving out of state, or giving up certain medical procedures, such as delivering babies. The analysis also examined the state's legal and judicial climate, the affordability and availability of professional liability insurance, jury award trends, and more.
In the midst of a medical liability crisis, some physicians who cannot get coverage from a state-licensed
medical liability insurer are turning to surplus lines insurance for coverage, reported American Medical News (2/17/03). While the precise number of surplus lines policies sold to physicians nationwide is unknown, "piecemeal information provided by companies and states indicated it's not a lot but it is more than usual."
Surplus lines insurers, which are not licensed by the state, guarantee coverage when no state-licensed insurer will. Such policies can be expensive since they are written based on an individual's experience, and the terms can change at any time during the course of the contract. Moreover, the policy may include a deductible and, if the surplus lines insurer goes bankrupt, there is no state guaranty fund to cover the policyholders' losses.
But for some physicians, surplus lines insurance is the only option for medical liability coverage. Physicians are having trouble finding coverage in some states because of a declining number of state-licensed insurers. Of those insurers that remain, an increasing number are dropping or refusing to write new policies for doctors with any claims history or physicians who practice in high-risk specialties such as obstetrics/gynecology.
In a 3-2 decision, the Utah Supreme Court upheld the state's Wrongful Life Act. The act "prohibits someone from suing because they would have aborted a fetus if it weren't 'for the act or omission of another person,'" according to American Medical News (2/3/2003).
While the decision may help protect physicians who misinterpret the results of prenatal genetic screening, some argue that the law opens the door for physicians opposed to abortion to withhold information from pregnant women who may want the procedure.
The case before Utah's high court involved a couple who had sought genetic counseling for their unborn child. Tests performed at the University of Utah Medical Center, Salt Lake City, indicated that the child had an 85% chance of being born with Down syndrome but court records indicated that physicians at the medical center downplayed the test results, leading the couple to believe that there was only a small chance that their child would be born with the condition.
The couple's child was born with Down syndrome in 1998, and the couple sued the medical center.
The couple alleged that the medical center's physicians were negligent in performing and interpreting the test results, leaving the couple unable to make an informed decision as to whether to continue the pregnancy. The couple also claimed that the Wrongful Life Act was unconstitutional.
The majority of the state Supreme Court disagreed, and ruled that the act was constitutional and that it did not interfere with a woman's right to an abortion.
Two judges dissented, arguing that the act was unconstitutional because the statute prevented the couple from seeking a remedy for their injury in court. In addition, one of the dissenting judges agreed with the couple's claim that the physicians' negligence interfered with the couple's right to make an informed decision about the pregnancy.
While both patients and physicians agree that medical errors should be disclosed, each has a different perspective on what should be revealed about the error, according to a study in The Journal of the American Medical Association (2/26/03).
All of the 52 patients who participated in one of 13 focus groups said they wanted to be told about any error that caused them harm. The researchers found that patients wanted to know how and why the error occurred, how the error would affect their health, and what steps would be taken to correct the error and prevent a recurrence. The patients also wanted physicians to apologize for the error. Taking these steps, the patients revealed, would ease concerns that information about their care was being withheld and would enhance their trust in their physicians.
In contrast to the patients' desire for full disclosure, the 46 physicians participating in the focus groups expressed a "more circumspect" attitude. While the physicians were committed to being truthful with patients regarding medical errors, they limited what they revealed and chose their words carefully when discussing the error. Although most of the participating physicians expressed a desire to apologize for errors, they feared that doing so would be construed as an admission of legal liability.
The researchers concluded, "Physicians should recognize that they may not be providing the information patients want about errors and should disclose the following minimal information about harmful errors regardless of whether the patient asks: (1) an explicit statement that an error occurred; (2) a basic description of what the error was, why the error happened, and how recurrences will be prevented; and (3) an apology."
The researchers based their findings on their observations of 13 focus group discussionssix groups involving patients only, four involving physicians only, and three including both physicians and patientsheld between April and June 2002. The focus groups' participants were presented with hypothetical situations involving a medication error, and were asked to discuss the scenario and their reactions.
While managed care has gone through a number of incarnations, it is an entrenched part of the health-care system, reported Managed Care magazine (1/2003), citing a recent survey of physician practice review by the Center for Studying Health System Change.
The survey found that nearly 91% of physicians contracted with managed-care companies in 2001, and the average number of managed-care contracts per physician rose from 12.4 in 1997 to 13.1 in 2001. The survey also found that physicians who contracted with managed-care companies derived about 46% of their practice revenue from these sources in 2001, while the share of revenue from capitation has declined after hitting its peak in the 1990s.
When it comes to financial incentives, the survey found that the use of profiling, patient-satisfaction surveys, and quality-of-care metrics had declined. Managed Care reported, however, that at least anecdotally, "during 2002, after the survey's end, many large MCOs began to endorse quality-of-care bonuses in physician contracts."
New Mexico became the 47th state to take advantage of a federal law, that gives states the option to expand Medicaid coverage to certain women who were screened through a federal screening program and identified as having breast or cervical cancer. The Department of Health and Human Services approved New Mexico's plan to insure women whose cancer was detected through the Centers for Disease Control and Prevention's National Breast and Cervical Cancer Early Detection Program (NBCCEDP) in October 2002.
The NBCCEDP was created in 1990 to improve access to early detection screening for breast and cervical cancers among underserved women. The program provides free screening and diagnostic services in all 50 states plus the District of Columbia, six US territories, and 14 American Indian/Alaska Native organizations.
To be eligible for Medicaid under the option provided by the Breast and Cervical Cancer Prevention and Treatment Act of 2002, a woman must have been screened for and found to have breast or cervical cancer, including pre-cancerous conditions, through the NBCCEDP. She must also be younger than 65 and be uninsured and otherwise not eligible for Medicaid. Under the law, according to HHS, these women may be eligible for Medicaid benefits for the duration of their cancer treatment.
In a survey of graduates from medical schools in the United Kingdom in 1999 and 2000, researchers from the University of Oxford found that the number of graduates who chose obstetrics and gynecology as their long-term career has decreased by around half since 1996.
The researchers, whose findings were published in the British Medical Journal (1/25/2003), found that 125 medical graduates chose obstetrics and gynecology as their first choice of long-term career in 1996. Only 53 graduates in 1999 and 66 graduates in 2000 chose the specialty as their first choice.
"Concerns about career prospects in obstetrics and gynecology have reduced the numbers choosing this specialty to the lowest ever recorded in our surveys," wrote the researchers.
In addition to these findings, the results of the survey indicated that 10.3% of the graduates "definitely" or "probably" did not intend to practice medicine in the UK. Moreover, of those who were undecided, 25% had doubts about practicing there.
Professional update May 2003. Contemporary Ob/Gyn May 1, 2003;48:11.