New guidelines uphold levothyroxine as standard of care for hypothyroidism


Levothyroxine (L-T4) should remain as the standard of care for treating hypothyroidism, according to a new hypothyroidism guidelines released by the American Thyroid Association (ATA).

“Our guidelines offer reassurance to physicians and their patients [that] no changes are needed in the current standard of care for hypothyroidism in the majority of patients,” said Dr. Jacqueline Jonklaas, chair of the task force that reviewed the latest clinical data on hypothyroidism therapeutics and an associate professor at Georgetown University Medical Center in Washington, DC, US.

The taskforce was convened to determine whether the current standard of care for hypothyroidism should be revised, and if warranted, to identify potential therapeutic alternatives to L-T4 monotherapy. [Thyroid 2014;doi:10.1089/thy.2014.0028]

L-T4 is a synthetic form of the hormone thyroxine (T4) that is converted to triiodothyronine (T3) in the body. While L-T4 is effective in most patients, some feel unwell when taking the drug, which is a cause for concern among physicians.

Although some studies suggested combination therapies may be a valid approach for patients with hypothyroidism, the taskforce concluded there was no robust evidence to recommend a change in the current standard of care.

“We found no consistently strong evidence for the superiority of alternative preparations [eg, levothyroxine-liothyronine combination therapy, or thyroid extract therapy] over monotherapy with L-T4 in improving health outcomes. However, some patients, particularly those with a polymorphism or genetic variation in the deiodinase enzyme that converts L-T4 [to T3], may benefit from combination treatments,” Jonklaas said.

Future research, she said, should focus on the development of superior biomarkers of euthyroidism to supplement thyroid stimulating hormone (TSH) measurements, mechanistic research on serum T3 levels (including effects of age and disease status, relationship with tissue concentrations, and potential therapeutic targeting), and clinical trials evaluating the long-term effects of different combination therapies or thyroid extracts.

Dr. Hossein Gharib, ATA president and professor of medicine at the Mayo Clinic College of Medicine in Rochester, Minnesota, US said while some questions remain unanswered, the new guidelines provide useful up-to-date information for endocrinologists and physicians on who to treat, why to treat, including subclinical disease, and how to treat hypothyroidism.

Pharmacists for their part can encourage patients to adhere with their medication unless advised otherwise by their physician and to report any adverse effects associated with excessive amounts of thyroid hormone such as palpitations, rapid weight loss, restlessness, sweating, and insomnia.

TSH suppression after thyroidectomy increases osteoporosis risk in women.


 Suppressing thyroid-stimulating hormone after thyroid cancer resection increases the risk for osteoporosis without decreasing recurrence, according to data presented at the American Thyroid Association meeting.

 “TSH suppression up to 0.4 mU/L increases the risk of osteoporosis without changing recurrence in thyroid cancer patients at low and intermediate risk of recurrence,” said Laura Y. Wang, MD, of the department of surgery at Memorial Sloan-Kettering. “Thus, future therapeutic efforts should focus on avoiding harm in indolent disease.”

Wang presented a retrospective study looking at patients who had a total thyroidectomy at Memorial Sloan-Kettering Cancer Center from 2000 to 2006 with a median follow-up of 6.5 years. The study criteria excluded patients with primary hyperparathyroidism, fewer than three postoperative TSH lab results, preoperative atrial fibrillation, preoperative osteoporosis, and considered high risk by the ATA; they also excluded men from the osteoporosis analysis. After these exclusions, the study looked at 771 total patients and 537 patients in the osteoporosis analysis.

Patients with median TSH ≤0.4 mU/L were considered TSH suppressed. TSH labs were analyzed up to original recurrence or last follow-up.

“TSH suppression was the most powerful independent predictor of osteoporosis, conferring a nearly fourfold risk of development of postoperative osteoporosis,” Wang said. “The impact on TSH on osteoporosis risk was even higher on univariate analysis, increasing the HR from almost 3.5 to 4.3. This suggests that there is possibly a synergistic effect between older age and TSH suppression.”

The disease-free survival analysis showed that 43 of 771 (5.6%) patients recurred (HR=1.02; 95% CI, 0.54-1.91). After multivariate adjustment for age, gender, ATA risk of recurrence and administration of radioactive iodine, TSH suppression did not prevent recurrence (HR=0.88; 95% CI, 0.46-1.66).

The survival estimate for osteoporosis in this group showed 29 of the 537 (5.4%) developed postoperative osteoporosis (HR=3.5, 95% CI, 1.2-10.2). After multivariate analysis, the HR increased to 4.32 (95% CI, 1.45-12.85).

“It appears that at a TSH level of around 0.9-1 [mU/L], the risk of osteoporosis disappears but the risk of tumor recurrence remains unchanged,” Wang said.

Soure: Endocrine Today

Levothyroxine could suppress TSH in subclinical thyroid disease.


The common practice of prescribing levothyroxine sodium to improve thyroid function among patients with subclinical thyroid disease may increase the potential for overtreatment, according to data in a United Kingdom-based retrospective cohort study.

Peter N. Taylor, MSc, MRCP, of the Cardiff University School of Medicine, and colleagues used data from the United Kingdom Clinical Practice Research Datalink to assess the trends in thyroid-stimulating hormone levels at the beginning of levothyroxine therapy and the risk for developing TSH suppression after treatment. The dataset included more than 52,000 patients who were given a prescription for the drug between January 2001 and October 2009, according to data.

“Overall, 30% of people were treated for levels of thyroid hormone deficiency potentially below those recommended in national guidelines, equivalent to 190,000 people in the UK. In addition, when thyroid blood levels were rechecked after 5 years on treatment, more than 1 in 10 people on levothyroxine were being overtreated,” Taylor told Endocrine Today.

Median TSH levels at the beginning of levothyroxine treatment decreased from 8.7 mIU/L to 7.9 mIU/L from 2001 to 2009, according to data. Five years after levothyroxine was initiated, 5.8% of patients displayed a TSH level of <0.1 mIU/L.

In 2009, patients with TSH levels of ≤10 mIU/L were prescribed levothyroxine more frequently compared with those treated in 2001 (OR=1.30; 95% CI, 1.19-1.42), according to data.

Between 2001 and 2006, there was a 1.81-fold increase in the rate of index levothyroxine prescriptions, researchers wrote. After adjustments for age, data revealed that there was still a 1.79-fold increase in the rate of index levothyroxine prescriptions.

Furthermore, older patients and those with cardiovascular disease risk were more likely to undergo levothyroxine treatment with TSH levels ≤10 mIU/L, according to researchers.

Moreover, patients with depression or tiredness at baseline showed an increased likelihood for developing TSH-suppression, unlike patients with CVD risk factors (ie, atrial fibrillation, diabetes, hypertension and raised lipids), researchers wrote.

The American Thyroid Association guidelines currently recommend levothyroxine therapy at TSH levels ≤10 mIU/L, when there are clear symptoms of hypothyroidism, positive thyroid autoantibodies, or signs of atherosclerotic CVD or heart failure.

“Taken together, this indicates that not only has the number of people being tested and treated for low thyroid hormone levels increased, but the majority of people nowadays are starting thyroid hormone for minor levels of underactivity for which we have no clear evidence of benefit,” Taylor said. “Studies are urgently required to clarify the risk vs. the benefits of exposing such a large number of these people to long-term thyroid hormone therapy.” – by Samantha Costa

Soure: Endocrine Today

Is Hypothyroidism Overdiagnosed and Overtreated?


Over the past decade, doctors have become increasingly aggressive at initiating treatment for borderline hypothyroidism, possibly raising the risk for thyroid suppression as an unintended consequence, a new study suggests.

The American Thyroid Association recommends considering levothyroxine therapy at thyroid-stimulating hormone (TSH; thyrotropin) levels of 10 mIU/L or lower if symptoms of hypothyroidism, positive thyroid autoantibodies, or evidence of atherosclerotic cardiovascular disease or heart failure are present. But starting levothyroxine at or below 10 mIU/L in those without symptoms may do more harm than good, it cautions.

Yet in this new 9-year survey of more than 52,000 individuals in the United Kingdom, the number of individuals who received levothyroxine for a thyrotropin level of less than 10 mIU/L increased by 30% over the course of the study.

“This practice may be harmful, given the high risk of developing a suppressed thyrotropin level after treatment,” say the researchers, led by Peter N. Taylor, MRCP, from the Thyroid Research Group at the Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine, United Kingdom, and colleagues, whose findings are published online October 7 in JAMA Internal Medicine.

Asked to comment on the findings for Medscape Medical News, Leonard Wartofsky, MD, chair of the department of medicine, Washington Hospital Medical Center, Washington, DC, said the authors are “raising the red flag that there is potentially overdiagnosis and overtreatment that has some risks.”

Most healthy people have thyrotropin levels less than 2.5 mIU/L, he explained. “If you simply go by the numbers, it’s hard to reconcile a TSH level of 7.9 as being normal when the rest of the population has numbers of 2.5 or less.” However, he added, thyrotropin levels do rise with age, so higher levels are normal for people 70 years of age or more and do not necessarily indicate treatment is necessary.

“Part of the problem is that this is a mild abnormality, and in most published studies it’s been difficult to show a clear benefit of intervention, because the number of subjects participating has been small, the abnormalities are minor, and you can’t show a major clinical effect of intervention,” Dr. Wartofsky observed. “This is a controversial issue, and it’s still unsettled.”

Threshold Lowered After 2004

Using the General Practice Research Database (GPRD; now called the Clinical Practice Research Datalink), which contains the records of more than 5 million patients in 508 primary-care practices across the United Kingdom, Dr. Taylor and coauthors conducted a retrospective cohort study of 52,298 adults who initiated levothyroxine therapy between January 1, 2001, and October 30, 2009, at a median age of 59 years.

Excluded from the study were people with a history of hyperthyroidism, pituitary disease, or thyroid surgery; those who were taking medication that affected thyroid function or whose thyroid problems were related to pregnancy; and/or those whose thyrotropin had been measured more than 3 months prior to beginning treatment.

To gauge the effect of therapy on thyroid function, they also studied thyrotropin levels at 30 to 36 months and 54 to 60 months after treatment began. Female patients outnumbered males by almost 4 to 1.

Following multivariate adjustment, the odds ratio of a patient receiving a levothyroxine prescription for a presenting thyrotropin level of less than 10.0 mIU/L in 2009 compared with 2001 was 1.30 (P < .001), and the number of new levothyroxine prescriptions increased by 74% over the study period.

The median thyrotropin level for initiating treatment fell from 8.7 mIU/L in 2001 to 7.9 mIU/L in 2009.

Individuals prescribed levothyroxine with a thyrotropin level between 4.0 and 10.0 mIU/L instead of exceeding 10.0 mIU/L were more likely to be female, have cardiovascular risk factors, and be older than 70 years when prescribed levothyroxine after 2004, with trends also observed for tiredness and depression, the authors write.

They conclude that “large-scale, prospective studies are required to assess the risk/benefit ratio of current practice.”

Overtreatment Can Lead to Problems, but So Can Undertreatment

Dr. Wartofsky said the study was designed to address whether starting levothyroxine therapy too early may result in overtreatment

Follow-up data showed that the percentage of patients with thyrotropin levels less than 0.1 mIU/L increased from 2.7% to 5.8% and the percentage of those with levels between 0.1 and 0.5 mIU/L increased from 6.3% to 10.2%, suggesting the presence of thyroid suppression. This “could lead to cardiac problems, arrhythmias, and atrial fibrillation and over the long term could lead to loss of bone mineral, osteopenia, and osteoporosis,” he explained.

But, he added, “I’m not particularly overwhelmed by the fact that only 5.8% of the patients were so oversuppressed. I think that is not unusual, even in the hands of expert endocrinologists — sometimes you oversuppress inadvertently.”

And the study does not show what the benefits of earlier treatment might be, probably because it takes longer for them to become apparent, he said. “In my view, there are compelling data that treating these populations does have a salutary effect”: lower serum cholesterol, a lower risk of coronary artery disease, and general symptom relief, among other things.

Is Hypothyroidism Overdiagnosed and Overtreated?


Over the past decade, doctors have become increasingly aggressive at initiating treatment for borderline hypothyroidism, possibly raising the risk for thyroid suppression as an unintended consequence, a new study suggests.

The American Thyroid Association recommends considering levothyroxine therapy at thyroid-stimulating hormone (TSH; thyrotropin) levels of 10 mIU/L or lower if symptoms of hypothyroidism, positive thyroid autoantibodies, or evidence of atherosclerotic cardiovascular disease or heart failure are present. But starting levothyroxine at or below 10 mIU/L in those without symptoms may do more harm than good, it cautions.

Yet in this new 9-year survey of more than 52,000 individuals in the United Kingdom, the number of individuals who received levothyroxine for a thyrotropin level of less than 10 mIU/L increased by 30% over the course of the study.

“This practice may be harmful, given the high risk of developing a suppressed thyrotropin level after treatment,” say the researchers, led by Peter N. Taylor, MRCP, from the Thyroid Research Group at the Institute of Molecular and Experimental Medicine, Cardiff University School of Medicine, United Kingdom, and colleagues, whose findings are published online October 7 in JAMA Internal Medicine.

Asked to comment on the findings for Medscape Medical News, Leonard Wartofsky, MD, chair of the department of medicine, Washington Hospital Medical Center, Washington, DC, said the authors are “raising the red flag that there is potentially overdiagnosis and overtreatment that has some risks.”

Most healthy people have thyrotropin levels less than 2.5 mIU/L, he explained. “If you simply go by the numbers, it’s hard to reconcile a TSH level of 7.9 as being normal when the rest of the population has numbers of 2.5 or less.” However, he added, thyrotropin levels do rise with age, so higher levels are normal for people 70 years of age or more and do not necessarily indicate treatment is necessary.

“Part of the problem is that this is a mild abnormality, and in most published studies it’s been difficult to show a clear benefit of intervention, because the number of subjects participating has been small, the abnormalities are minor, and you can’t show a major clinical effect of intervention,” Dr. Wartofsky observed. “This is a controversial issue, and it’s still unsettled.”

Threshold Lowered After 2004

Using the General Practice Research Database (GPRD; now called the Clinical Practice Research Datalink), which contains the records of more than 5 million patients in 508 primary-care practices across the United Kingdom, Dr. Taylor and coauthors conducted a retrospective cohort study of 52,298 adults who initiated levothyroxine therapy between January 1, 2001, and October 30, 2009, at a median age of 59 years.

Excluded from the study were people with a history of hyperthyroidism, pituitary disease, or thyroid surgery; those who were taking medication that affected thyroid function or whose thyroid problems were related to pregnancy; and/or those whose thyrotropin had been measured more than 3 months prior to beginning treatment.

To gauge the effect of therapy on thyroid function, they also studied thyrotropin levels at 30 to 36 months and 54 to 60 months after treatment began. Female patients outnumbered males by almost 4 to 1.

Following multivariate adjustment, the odds ratio of a patient receiving a levothyroxine prescription for a presenting thyrotropin level of less than 10.0 mIU/L in 2009 compared with 2001 was 1.30 (P < .001), and the number of new levothyroxine prescriptions increased by 74% over the study period.

The median thyrotropin level for initiating treatment fell from 8.7 mIU/L in 2001 to 7.9 mIU/L in 2009.

Individuals prescribed levothyroxine with a thyrotropin level between 4.0 and 10.0 mIU/L instead of exceeding 10.0 mIU/L were more likely to be female, have cardiovascular risk factors, and be older than 70 years when prescribed levothyroxine after 2004, with trends also observed for tiredness and depression, the authors write.

They conclude that “large-scale, prospective studies are required to assess the risk/benefit ratio of current practice.”

Overtreatment Can Lead to Problems, but So Can Undertreatment

Dr. Wartofsky said the study was designed to address whether starting levothyroxine therapy too early may result in overtreatment

Follow-up data showed that the percentage of patients with thyrotropin levels less than 0.1 mIU/L increased from 2.7% to 5.8% and the percentage of those with levels between 0.1 and 0.5 mIU/L increased from 6.3% to 10.2%, suggesting the presence of thyroid suppression. This “could lead to cardiac problems, arrhythmias, and atrial fibrillation and over the long term could lead to loss of bone mineral, osteopenia, and osteoporosis,” he explained.

But, he added, “I’m not particularly overwhelmed by the fact that only 5.8% of the patients were so oversuppressed. I think that is not unusual, even in the hands of expert endocrinologists — sometimes you oversuppress inadvertently.”

And the study does not show what the benefits of earlier treatment might be, probably because it takes longer for them to become apparent, he said. “In my view, there are compelling data that treating these populations does have a salutary effect”: lower serum cholesterol, a lower risk of coronary artery disease, and general symptom relief, among other things.

Source: JAMA

Thyroid Screening Neglected in Hypercholesterolemia.


Just half of primary-care patients with hypercholesterolemia received recommended thyroid-function screening, a new retrospective study has found.

The findings were presented here at the American Association of Clinical Endocrinologists (AACE) 2013 Scientific & Clinical Congress by Devina Willard, MD, an internal-medicine resident at Boston Medical Center, Massachusetts.

Hypothyroidism is an important secondary cause of elevated total cholesterol and LDL cholesterol. In overt hypothyroidism cases, thyroid hormone replacement treatment often normalizes the cholesterol levels. For that reason, guidelines from the AACE, American Thyroid Association, and National Cholesterol Education Program (NCEP) recommend testing for hypothyroidism.

Dr. Willard‘s study was designed to determine the rate of adherence to the guidelines by primary-care physicians. “The 50% rate of screening is a bit surprising. Although guidelines from the NCEP and [American College of Physicians] ACP state that thyroid dysfunction is [included in the] differential [diagnosis] for new-onset dyslipidemia, the practice of screening in standard clinical practice seems to often be overlooked,” she told Medscape Medical News.

Important to Treat Underlying Cause of Hyperlipidemia

Dr. Willard and colleagues reviewed charts from patients aged 18 years and older with total-cholesterol levels of 200 mg/dL and/or LDL-cholesterol levels of 160 mg/dL or above, who were seen at Boston Medical Center’s internal-medicine and family-medicine clinics for routine care during 2003 – 2011. Patients who had previously taken lipid or thyroid medications were excluded.

Of the 8795 patients newly diagnosed with hypercholesterolemia, thyroid-stimulating hormone (TSH) levels had been checked within 6 months of the diagnosis for 49%. Peripheral thyroid-function tests were also done for 18.4% of the patients.

Of the total 4349 patients who had TSH levels screened, 151 had TSH levels greater than 5 mIU/L and 74 had TSH levels over 10 mIU/L. Of these 225 patients (with TSH levels >5), 50.7% received levothyroxine treatment, Dr. Willard reported.

Of those 114 patients treated with levothyroxine, 75.4% did not receive a lipid-lowering agent within 1 year, possibly because correction of their hypothyroidism resulted in improvement of their lipid panel and correction of the dyslipidemia, she said.

The clinical implications of the findings are identifying a treatable cause of dyslipidemia and saving on the potential costs of long-term management of cholesterol-lowering therapy in many individuals, as well as reducing risk for cardiovascular events, Dr. Willard told Medscape Medical News.

She added, “We agree with the guidelines… It is important to treat the underlying and potentially reversible cause of dyslipidemia. However, we would conclude that more research is needed to better assess the cost/benefit effectiveness of having these guidelines be universally adopted.”

Source: medscape.com

 

 

ATA issues guidelines for anaplastic thyroid cancer management.


The American Thyroid Association has released the first set of comprehensive guidelines for the management of anaplastic thyroid cancer, a rare but lethal form of thyroid cancer.

Members of the American Thyroid Association (ATA) task force compiled a list of 65 recommendations based on relevant literature.

 

Bryan R. Haugen

“The American Thyroid Association Guidelines for Management of Patients with Anaplastic Thyroid Cancer is a remarkable and comprehensive document that distills the literature and task force expertise into a useful guide for providers of patients with this aggressive cancer. The focused therapeutic approaches, as well as the inclusion of palliative care and ethical issues into this document, is a real advance for our field,” ATA president and professor of medicine and pathology; head of the division of endocrinology, metabolism and diabetes at the University of Colorado School of Medicine, Bryan R. Haugen, MD, said in a press release.

According to the guidelines published in Thyroid, the ATA task force sought to address the following: diagnosis, initial evaluation, establishment of treatment goals, approaches to locoregional disease (i.e., surgery, radiotherapy, systemic therapy, and supportive care during active therapy), approaches to advanced/metastatic disease, palliative care options, surveillance and long-term monitoring, and ethical issues regarding end-of-life.

For more information:

Smallridge RC. Thyroid. 2012; doi: 10.1089/thy.2012.0302.

Perspective

 

Richard T. Kloos

  • ATC is a rare, rapidly growing and [usually] fatal disease. Few physicians have personal expertise, and the published literature tends to be of low quality. Thus, when a patient presents at their doorstep, unfamiliar physicians are ill equipped to manage the disease.

The ATA brought together experts from a range of disciplines that synthesize the published literature and combine it with their clinical experience to thoughtfully guide physicians through the complexities of an ATC diagnosis, evaluation, staging and the establishment of treatment goals. This latest endeavor includes disclosing the patient’s status in a realistic way, including a discussion of treatment risks and benefits, the discussion of patient values and preferences, and the eventual making of an informed decision.

Unfortunately, physicians see patients in their best condition at the time of the first appointment, as most patients with ATC progressively decline in health and die from the disease in less than 6 months. Therefore, important decisions are needed quickly to address the remainder of their life. The document includes important sections of surrogate decision making, truth telling, advanced directives, airway management, maintenance of nutrition and palliative care/hospice.

This is the first set of comprehensive guidelines on this topic, and Dr. Smallridge and the ATA Task Force are to be congratulated for creating such a thoughtful and extensive document. Readers should quickly appreciate that to treat these patients they need to have an awaiting comprehensive multidisciplinary treatment team on-site to receive such patients, in addition to a group that can review this document to discuss their institutional approach moving forward. Conversely, physicians need to know how and where to rapidly transfer patients into the care of such a team.

Historically, guidelines have improved patient care in the short term by educating physicians and guiding patient care. In the long term, guidelines improve patient care by driving research. Gaps in the medical literature are identified and disagreements over strategies can be appropriately studied to strengthen the evidence base and to change patient care. We all hope that this is the case for ATC, and this document sets the benchmark for optimal care in 2012.

Source: Endocrine Today.

New approaches to thyroidectomy prompt discussion.


During an academic debate held here, two presenters focused on the pros and cons of conventional vs. minimally invasive approaches to thyroidectomy.

In the process, some of the concerns that patients now harbor, particularly in terms of cosmetic effects, came to the forefront.

“The frontiers of thyroidectomy today focus on minimizing pain and maximizing cosmesis and preventing long hospital stays,” Carmen C. Solorzano, MD, professor of surgery and director of the Vanderbilt Endocrine Surgery Center, said during a presentation at the American Thyroid Association 82nd Annual Meeting.

Gold standard

Conventional thyroidectomy consists of a Kocher incision and requires elevation of large flaps, often with the use of a surgical drain, to allow complete exposure of the thyroid gland, according to Solorzano, whereas a minimally invasive approach involves an incision in the cervical area that is small and requires less extensive dissection. These approaches include minimally invasive video-assisted thyroidectomy (MIVAT), minimal incision and endoscopic minimally invasive thyroidectomy, but not remote approaches to the thyroid gland, such as the robotic facelift thyroidectomy.

Solorzano, who spoke in favor of the conventional approach, noted that a meta-analysis showed that the rate of recurrent nerve palsy between the two approaches was the same, although cosmetic satisfaction and pain scores were better in the minimally invasive thyroidectomy group. The conventional approach, however, was associated with shorter operative times, lower cost and wider applicability, she said. Additionally, conventional thyroidectomy remains the standard approach for Graves’ disease, which usually involves very large glands, and bulky cancer, as these would be difficult to remove through small incisions.

“The fact remains that one of the drawbacks to the minimally invasive approach is that it is only appropriate in about 5% to 30% of cases,” Solorzano said. “Major limitations are thyroid size, thyroiditis or toxic glands and cancer or adenopathy.”

Nevertheless, patients can still experience the benefits associated with minimally invasive surgery, according to Solorzano, as long as surgeons adapt by considering cosmesis with smaller incisions in the skin crease, using magnification and lighting, and paying attention to the edges of the wound.

“The conventional thyroidectomy remains the gold standard approach to removing the thyroid gland,” Solorzano said. “The minimally invasive approach remains an option but is limited by thyroid size and pathology.”

For select patients

Although not appropriate for all, according to Maisie L. Shindo, MD, FACS, patients and physicians may benefit from the MIVAT approach, which is similar to a laparoscopic procedure in which a high definition camera is used that allows the surgeon to dissect using a monitor.

“An advantage of the high definition camera is you can really see the nerve in magnified view and then just take out the thyroid,” Shindo, who is director of thyroid and parathyroid surgery at Oregon Health & Science University, said.

She also cited data from several studies suggesting that patients who underwent MIVAT experienced somewhat better outcomes vs. those who underwent conventional thyroidectomy. In a 2002 prospective study comparing post-operative pain at 24 and 48 hours after the procedure, for instance, indicated that post-operative pain was better in the MIVAT group. Similarly, a 2004 study showed that patients in the MIVAT group experienced better cosmetic and pain results than those in the conventional approach group.

Additionally, a study comparing minimally invasive thyroidectomy without video with mini-incision revealed that pain was significantly lower among patients who underwent surgery with the minimally invasive approach, according to Shindo.

She expressed concern, however, about the use of MIVAT in patients with thyroid cancer where the surgeon would likely be performing a total thyroidectomy and potentially removing lymph nodes as well, and noted that becoming skilled in using MIVAT requires time.

“My argument is that MIVAT is safe with the appropriate patient selection,” Shindo said. “It does provide a small incision and less pain, but there is a learning curve like with any other laparoscopic procedure. You have to be very experienced because there can be anatomic variations, so you have to be aware of that.”

Perspective

 

David J. Terris

  • I thought both of the speakers made very balanced and informed presentations. It’s always a challenge assessing new technology and new procedures, and I thought they both did a great job of presenting fair arguments about the procedures.

Much of the discussion was about minimally invasive techniques, but there was mention of robotic surgery, and it was clear that neither speaker was necessarily supportive of that approach. I think they drew an important distinction between minimally invasive surgery and robotic remote access surgery conventional techniques because sometimes the lines get blurred by the uninformed who may think that robotic surgery must be minimally invasive. For other procedures, such as robotic prostatectomy, it is. In many respects, it is minimally invasive, but when we refer to thyroid surgery and remote locations like the armpit or behind the ear, there’s more dissection involved just to get to where the thyroid gland is. The reason the robot is so valuable in those cases is because you’re working down a long tunnel and you can use these very minitaturized instruments to a) provide tremendous 3-D visualiation and b) the maneuverability of the instruments in that small space is so superior that if you’re going to do remote access surgery, it’s much easier if you use the robot. But the overall technique itself, the remote access techniques, is more invasive, but I was pleased to see that each of the speakers kind of emphasized that point.

Source: Endocrine Today.

 

Evidence supports optional use of RAI for papillary thyroid cancer.


The use of radioactive iodine for the management of papillary thyroid cancer has been recommended for years, but researchers said it should not be a “blanket treatment” for all patients.

Guidelines for the management of well-differentiated thyroid cancer (WDTC) recommend routine usage of radioactive iodine (RAI) in patients with T3 disease or distant metatases, and selected use in patients with more limited disease.

However, lain J. Nixon, MBCHB, clinical fellow in the head and neck surgery department of Memorial Sloan-Kettering Cancer Center, told Endocrine Today that, due to a lack of evidence, the American Thyroid Association’s guidelines are not definitive for most patients when it comes to treatment.

“Over the years, different groups have looked at outcomes of patients who were treated with RAI. And initially, it dramatically improved patient outcomes. But, as treatment has progressed over the years and surgery is better now than it was in the 1940s, groups have discovered the  benefit is probably limited to high-risk patients,” Nixon said. “We now know that high-risk patients benefit, but low-risk patients don’t. The difficulty for clinicians is that most patients are somewhere between those two extremes, and there isn’t very good guidance about who should and should not receive RAI in that middle group.”

Nixon and colleagues conducted a review of 1,129 patients (median age of 46 years) who underwent total thyroidectomy at Memorial Sloan-Kettering Cancer Center between 1986 and 2005. After an average follow-up of 63 months, the researchers found that some patients with early primary disease (pTl/T2) and low-volume metastatic disease in the neck (pTl/T2 N1) who were managed without RAI displayed positive outcomes.

“It’s not a study that proves whether RAI works or it doesn’t,” Nixon said. “The idea of it is to give clinicians who are interested in the concept of managing patients without RAI some evidence to back up that position.”

For patients with advanced local disease (pT3/T4), some patients with pT3NO disease were safely managed without RAI. The 5-year disease-specific survival (DSS) and recurrence-free survival (RFS) rates for the pTl/T2NO group were 100% and 92%; for the pT1/T2N1, rates were 100% and 92%; and for the pT3/T4 group, rates were 98% and 87%, according to data.

Despite the traditional recommendations, the researchers suggest that RAI should be administered on a case­by-case basis through a multidisciplinary team with extensive experience in managing thyroid cancer.

“Our experience is that in properly selected patients, it’s very safe to manage them without RAI,” Nixon said. – by Samantha Costa

.

Disclosure: The researchers report no relevant financial disclosures.

Perspective

 

Megan R. Haymart

  • Nixon and colleagues performed a retrospective review of 1,129 patients who underwent total thyroidectomy for thyroid cancer at a tertiary referral center between 1986 and 2005. They evaluated mortality and cancer recurrence in those patients that received radioactive iodine post thyroid surgery versus those that did not. They found that select patients do well without radioactive iodine treatment. This study suggests that it is time for the pendulum to swing. Although radioactive iodine treatment has clear benefit in high risk iodine avid patients, for many patients management with surgery alone may be adequate.
  • Source: Endocrine Today.

 

Experts debate benefits of routine nerve monitoring in thyroid surgery.


Although many clinicians use intraoperative nerve monitoring during thyroid surgery, data do not necessarily associate the practice with improved outcomes. The question of whether it should be used routinely was up for discussion at the American Thyroid Association 82nd Annual Meeting.

Potential benefits

Jennifer E. Rosen, MD, FACPS, assistant professor of surgery and molecular medicine at Boston University School of Medicine, said that nerve monitoring may be beneficial from a cost standpoint, explaining that post-operative permanent nerve injury and post-operative permanent hypothyroidism are the driving force behind the majority of lawsuits in thyroid surgery.

She also highlighted several uses for intraoperative nerve monitoring in thyroidectomy. For instance, it offers more than visual confirmation when identifying the recurrent laryngeal nerve, Rosen said. Additionally, nerve monitoring can help identify abnormalities in the anatomy of the nerve and aid in dissection. Further, she noted, nerve monitoring has value as a prognostic tool in terms of postoperative neural function.

The major question, however, is whether intraoperative nerve monitoring prevents nerve injury or paralysis during thyroidectomy. Although data are not completely positive, this may be due to several factors, according to Rosen, such as whether the surgeon performs pre-operative and post-operative laryngoscopy and in what setting; how many procedures the surgeon performs per year; what techniques are used; and more.

If a surgeon is going to use nerve monitoring, he or she should do it routinely, Rosen said. The surgeon should also perform pre- and post-operative laryngoscopy and voice assessment, as well as be very aware and knowledgeable about the type of equipment and approach to surgery that is being used.

“Based on the preponderance of evidence and an interpretation of the strengths and limitations of the data on which we base our decisions, and with some qualifications based on the type of surgery, the setting and the surgeon, then yes, [intraoperative nerve monitoring] should be done routinely,” she said.

A lack of data

However, David J. Terris, MD, FACS, Porubsky Professor and chairman of the department of otolaryngology at Georgia Health Sciences University and surgical director of the Thyroid Center, pointed out that the published scientific evidence does not support the routine use of nerve monitoring in thyroid surgery.

“It’s important to consider this in two different ways: what is the logic behind nerve monitoring vs. what about the data actually supporting the use of nerve monitoring? We want to consider those separately,” he said.

Terris cited four studies that failed to prove a connection between nerve monitoring and improved functional outcomes in thyroid surgery. For example, results from a trial conducted at 63 centers in Germany and involving 29,998 nerves demonstrated no differences in the nerve monitoring group when compared with the nerve identification and dissection group (although each of these methods were superior to an approach where the nerve is not sought and identified) . Similarly, researchers for another study involving 1,804 nerves at risk concluded no benefit to nerve monitoring (although both nerve monitoring and nerve stimulation and twitch palpation without nerve monitoring were able to predict nerve injury).

The potential for added costs, including a $300 endotracheal tube, additional time in the operating room and from $500 to $1,000 in surgical fees, is another possible downside to nerve monitoring, according to Terris. Complications such as airway obstruction, tongue necrosis and increased parasympathetic tone associated with clamping the vagus nerve are also concerns, he said. Moreover, clinicians may become reliant on the technology for identifying the nerve.

“One concern is training a new generation of surgeons who have inferior anatomical skills,” he said. “The bottom line is that [nerve monitoring] adds expense; has its own potential for complications; induces a false sense of security; and there’s no evidence that it does what it’s supposed to do, which is prevent injury.”  Despite these shortcomings, Dr. Terris indicated that he himself generally uses nerve monitoring because of subtle advantages associated with it, and incremental surgical information that it provides.

Source: Endocrine Today.