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December 23, 2011

ARDMS Updates and Headlines in the News:

ARDMS: Important Testing Center Update

Combining MRI with Prostate Ultrasound Biopsy Bests Biopsy Alone

Ultrasound Thrombolysis a Quick Clot Buster

Connecticut Density Law Leads to 'Flood' of Ultrasound Breast Screening

ARDMS: Important Testing Center Update

• At the test center, you must present two current, valid signature IDs, one of which must be a non-expired government-issued photo ID with your signature; see the accepted list of IDs here.
• The name on your application must EXACTLY MATCH the name on both current, valid signature IDs.
• Jane R. Doe and Jane Rachel Doe DO NOT EXACTLY MATCH.
• Failure to present two acceptable IDs will prevent your admission to the test center. If this happens, you will be marked absent and you will forfeit the entire examination fee and seat.
• If the names do not EXACTLY MATCH, update your ARDMS name of record. 

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Combining MRI with Prostate Ultrasound Biopsy Bests Biopsy Alone

Fusing MRI with real-time, three-dimensional ultrasound allows for more targeted prostate biopsies and finds additional cancers, compared with standard systematic biopsies.

"This may lead to fewer total biopsies, improved yield and improved confidence for active surveillance," Dr. Daniel J.A. Margolis said at the annual meeting of the Radiological Society of North America (RSNA).

Direct MRI-guided biopsy is not universally available, leaving most centers to use two-dimensional ultrasound to systematically biopsy 12 areas of the prostate, whether they are all suspicious or not. Not surprising, roughly 30% of systematic core biopsies are false negative, explained radiologist Dr. Margolis of the University of California, Los Angeles.

Researchers at UCLA departments and the medical device company Eigen have been using external-array 3 Tesla MRI scans, including T2-weighted, diffusion-weighted, and dynamic contrast-enhanced images to identify suspicious areas in the prostate. The areas are scored on a 5-point scale by a radiologist based on cancer risk, and the data are used to create a 3-D contoured reconstruction that is fused with real-time, transrectal ultrasound during biopsy.

Early results were promising in the two groups of men most likely to benefit from the new imaging technology – those with a prior negative biopsy and elevated prostate-specific antigen (PSA) levels and those with low-risk prostate cancer under active surveillance. In 47 such men, the biopsy-positivity rate was 33% with MRI-fusion ultrasound vs. 7% for systematic, non-targeted biopsy.

At the meeting, Dr. Margolis presented data from 57 consecutive men with a previous biopsy, in whom MRI-fusion ultrasound identified 101 suspicious areas. In all, 22 men had 28 positive MRI targets.

Positive biopsies were found in 12 patients on targets only. Nine patients had positive lesions on both MRI-fusion ultrasound and systematic biopsy. In one additional patient, the positive systematic core was changed from Gleason 3+3 to 3+4 disease with the targeted biopsy.

Seven patients had positive biopsies found on systematic biopsy only, although all were Gleason score 3+3, less than 4 mm in size and less than 25% of the core, Dr. Margolis said.

A separate study presented in the same session suggests that fusing MRI with transrectal ultrasound biopsy may also be useful in identifying aggressive tumors in men with no prior prostate biopsy or suspicious digital rectal exam and a PSA of 3-10 ng/mL (mean 8 ng/mL).

The overall cancer detection rate was 52% among 323 (168/323) such men, 73% within MRI targets (144/197) and 19% with sextant biopsy (24/126), reported Dr. François Cornud, a consultant radiologist at René Descartes University, Paris.

In 98 patients with both MRI targeted- and sextant-positive biopsies, targeted biopsies identified significantly more cancers with a Gleason score greater than 6 (44% vs. 25%), with a length in any core of more than 7 mm (50% vs. 25.5%) and with a longer mean length (5.3 mm vs. 0.8 mm).

Interestingly, performance was similar whether the multi-parametric MRI data were fused with the real-time ultrasound images visually or by a computerized electromagnetic navigator system.

"Targeted biopsies definitely provide better evaluation of tumor burden and Gleason score," Dr. Cornud said, adding that "a negative MRI prior to biopsy may mean no cancer or indolent cancer and may suggest that in these patients biopsy may be deferred."

Both studies were well received, although one attendee questioned whether the researchers have been able to convince frequently reluctant urologists that targeted biopsies are worth it. Dr. Margolis said his project was actually instigated by an urologist. Dr. Cornud said the majority of his urologists are now requesting an MRI and its findings.

View the article online.

Article written by staff at oncologyreport.com and adapted for the purposes of this newsletter.

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Ultrasound Thrombolysis a Quick Clot Buster

Ultrasound-accelerated thrombolysis treatment of submassive pulmonary embolism reduced right ventricular dilatation and the risk of heart failure, according to the results of a retrospective study of 29 patients at one facility.

"My end point is not so much seeing 100% clot clearance. My main goal of therapy is to see that regression of the right ventricle. We want to see that [right ventricle/left ventricle] ratio go back to normal to prevent long-term sequelae," said Dr. Tod C. Engelhardt, who presented the study results at the Veith Symposium on Vascular Medicine sponsored by the Cleveland Clinic.

Dr. Engelhardt and his colleagues found that ultrasound-accelerated thrombolysis (USAT) significantly reduced the right ventricle/left ventricle (RV/LV) ratio from 1.37 to 1.02 following treatment. All patients survived to hospital discharge, with a median time to follow-up CT of less than 48 hours. Symptoms such as dyspnea and difficulty speaking resolved 2-3 hours after the initiation of treatment.

"This is an interesting group because when they present, they don’t look too bad on paper or clinically," he said. These patients usually have normal blood pressure with minimal oxygen supplementation, but more than 90% have some dyspnea with exertion. About 40% of patients with PE have the submassive type, which has a 90-day mortality of 22%, compared with 58% for massive PE.

"The thing that separates them is right ventricular enlargement. They have impending right heart failure because of the right ventricular dilatation." An RV/LV ratio greater than 0.9 is considered significant, noted Dr. Engelhardt, chair of cardiovascular and thoracic surgery at East Jefferson General Hospital in Metairie, LA.

Patients with persistent RV dysfunction at discharge are approximately eight times more likely to have recurrent PE and four times more likely to die, compared with patients in whom RV dysfunction had regressed at discharge.

"There has to be a high index of suspicion of PE," he said in an interview. Usually the emergency physician will have chest computed tomographic angiography (CTA) done. "Once you get the scan, you can see the PE and the right heart size. Then I get an echocardiogram and a duplex scan of the lower extremities" to look for deep vein thrombosis.

However, "I have found that the CTA gives me everything that I need in order to make a decision and to proceed with therapy. The CTA does two things for me. I can see the extent of the involvement of the pulmonary embolism, and I can measure the relative sizes of the right and left ventricles to generate that ratio. This allows me to categorize the patient as a submassive PE patient and to move forward with therapy," he said.

Once the diagnosis of PE is made, the patient is started on anticoagulant therapy. "I don’t think that hinders what I do; in fact, it complements it."

With a submassive PE patient, "once I make the diagnosis and the patient is already anticoagulated, my next step is to move to the cath lab to place catheters and start [USAT] treatment."

With USAT, ultrasound energy causes fibrin strands to thin and loosen, exposing plasminogen receptor sites. Thrombus permeability and thrombolytic penetration are dramatically increased. Ultrasonic pressure waves force the thrombolytic deep into the clot, allowing the drug to work faster and clear the clot sooner with a lower drug dose and without hemolysis.

The goal of USAT is to accelerate thrombolysis and rapidly reverse right ventricular dilatation and reduce pulmonary clot burden. This improves pulmonary perfusion and reduces right heart load. Because a lower drug dose (no more than 20 mg of recombinant tissue plasminogen activator [TPA]) is used than with conventional treatment, the risk of bleeding is significantly lowered. Aggressive management of submassive PE can prevent more harmful consequences later, according to Dr. Engelhardt.

Dr. Engelhardt reported on the experience at his center, where surgeons treated 32 PE patients with ultrasound-accelerated thrombolysis between February 2009 and June 2011.

They performed retrospective data analysis on 29 consecutive patients with pre- and post-treatment contrast-enhanced CT imaging, clinical history, RV/LV ratio reduction, and clot burden reduction. They used this information to identify the optimum drug dose as a maximum of 20 mg recombinant TPA over 12 hours. This dose resulted in good clinical outcomes with no bleeding complications.

Adverse effects were limited. There were no intracranial hemorrhages or systemic bleeding complications. Four patients had puncture site bleeding that required transfusion. One patient had suspected recurrent PE.

Although there has been "trepidation in changing the status quo of anticoagulation alone," he said, "patients with massive and submassive emboli can be treated with USAT. Certainly patients who are in cardiogenic shock may have time for a catheter placement and can be treated with systemic TPA. Many massive PE patients can be resuscitated so that they do have time for catheter placement."

The catheters are inserted over a 0.35-inch guidewire through the femoral vein. "When I first started doing this – the first 10 or so patients – I did bilateral groin sticks because I’m placing bilateral pulmonary artery catheters," Dr. Engelhardt said.

He now uses a 10-French catheter that has two ports. "So I can now put catheters in each port and feed one into the right and one into the left." The catheter includes small ultrasound transducers and allows for thrombolytic drug delivery.

"I developed a protocol when I first started doing these cases. I was giving a bolus dose down each side – 4 mg each side – then I would run it for 12 hours at 0.5 mg per side. Since then, I’ve decided not to give a bolus dose but to run 0.5 mg per side for 20 hours." He now administers 20 mg total because he found that larger doses provide the same results as 20 mg but with complications such as groin hematomas.

"These catheters treat only what they’re in contact with, so I try to get these catheters as far into the periphery of the lung as I can. I’ve never had a perforation," he said.

View the article online.

Article written by staff at internalmedicinenews.com and adapted for the purposes of this newsletter.

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Connecticut Density Law Leads to 'Flood' of Ultrasound Screening

A 2009 law passed in Connecticut that requires women with dense breast tissue to be notified of their status has led to a "flood" of screening ultrasound exams at breast clinics in the state. The phenomenon could occur in other states that are considering similar laws, according to a presentation at the recent Radiological Society of North America (RSNA) 2011 meeting.

Teams from Yale-New Haven Hospital and the Hospital of Central Connecticut reported on the efficacy of breast ultrasound in dense breast tissue: So far, the results have been mixed. They also addressed how the increase in ultrasound imaging has affected their practices.

Their experiences could serve as a model for other states where legislation has either already been adopted -- such as Texas -- or is currently on the legislative front burner.

A flood of screening

Dr. Kathryn Greenberg, of Yale-New Haven Hospital, and colleagues investigated the performance of handheld screening breast ultrasound in women with dense breast tissue, in part to track the effects of the Connecticut law. They found that breast ultrasound's overall cancer detection rate was 0.32%, comparable to that of mammography. However, they also found that adding breast ultrasound screening to the mix changes a practice's workload.

"Prior to October 2009, [when the Connecticut law was passed,] we did not perform screening ultrasound at our institution," Greenberg told session attendees. "Since the law was passed, there's been a flood of screening breast ultrasound. I myself do about 40 ultrasounds per day."

Greenberg's team performed a retrospective review of 935 women with dense breasts on mammography who subsequently underwent handheld screening breast ultrasound between October 2009 and September 2010. The average length of time between mammography and ultrasound was 60 days, Greenberg said.

Sixty biopsies were performed in 52 patients out of the total cohort. Fifty-seven of these biopsies proved benign, and three proved malignant (all three malignancies were BI-RADS 4 lesions), Greenberg's team found.

Although the overall cancer detection rate was comparable between breast ultrasound and mammography, the overall positive predictive value for biopsy of these BI-RADS 4 lesions was 5.9%, quite a bit lower than mammography's 20%.

How much time did these ultrasound screening exams take, and who performed them? In the beginning, Greenberg's group scheduled 45-minute time slots, and the exams were performed by technologists who had received training in breast ultrasound and were supervised by physicians, according to Greenberg. As the group's technologists have become more experienced, the time slots for the exam have been reduced to 30 minutes.

Greenberg's practice has gotten creative to handle the overflow, she said.

"There's a growing trend to do screening breast ultrasound after hours, and if the technologist thinks there's an issue, the patient is pulled back for a diagnostic ultrasound during the day, with a physician," she said.

Breast ultrasound works ... sort of

In a related study, Dr. Jean Weigert, of the Hospital of Central Connecticut, and colleague Dr. Sarah Steenbergen, from the University of Connecticut, investigated whether screening breast ultrasound improves breast cancer detection in women with mammographically normal but dense breasts. They presented their findings in a poster at the RSNA meeting.

Weigert and Steenbergen conducted a retrospective chart review throughout Connecticut on the use of breast ultrasound exams for women with normal but dense breasts on screening mammography. They collected the total number of screening mammograms, screening ultrasounds broken down by BI-RADS codes, and the number of positive and negative biopsies from sites throughout Connecticut, as well as demographic data on the patients with positive biopsies and cancer staging.

The two researchers obtained data from five Connecticut radiology practices with more than 50,000 screening mammograms and more than 8,000 screening ultrasounds; about 40% of the patients included in the study had dense breasts. Of those patients, an estimated 50% received a follow-up breast ultrasound, Weigert said.

Weigert and Steenbergen found that breast ultrasound in women with mammographically normal but dense breasts had a positive predictive value of 4%, a negative predictive value of 99.9%, sensitivity of 94%, and specificity of 52%.

Although breast ultrasound can be effective in finding cancers missed by mammography, the extra time, cost, and risk of false positives must be considered as well, they concluded.

"Once the American College of Radiology Imaging Network 6666 trial demonstrated that ultrasound could find cancers that could not be seen on mammograms in women with dense breasts, we knew we would be unable to lobby against the legislation and remain credible in the eyes of the legislators," Weigert said. "But we remained concerned about the problem of the many potential false positives, as well as implementation -- never mind the fact that it's still unclear whether ultrasound improves mortality odds like screening mammography does."

A movement's roots

Why has Connecticut been ground zero for breast density reporting? The state has the second highest incidence of breast cancer in the nation, according to Weigert, and ranks 16th in the nation for breast cancer mortality rates. But the Connecticut bill was also prompted by the experience of Nancy Cappello, PhD, a Connecticut woman who received a diagnosis of advanced-stage breast cancer in 2004, at age 51.

Because Cappello had dense breast tissue, her cancer was not discovered by annual mammograms, even though she had already received more than 10. To address the issue of breast density, Cappello founded Are You Dense, an organization that urges women to be informed about dense breast tissue and how it affects the early detection of breast cancer.

Out of Are You Dense has come the Density Education National Survivors' Effort (DENSE), a grassroots organization that supports further breast density notification legislation. The group's efforts have proved fruitful in at least one other state: In June, Texas became the second U.S. state to mandate the inclusion of breast density risk language in reports sent to women after their mammograms. HB 2102, also known as "Henda's Law," took effect September 1.

More recently, however, breast density notification advocates received a setback when California Gov. Jerry Brown vetoed similar legislation in October.

Cappello's group has vowed to move forward despite the setback in California. A federal bill (HR 3102) was introduced in Congress soon after Brown vetoed the California legislation, and a number of states -- Kansas, Ohio, New Hampshire, New York, Virginia, and Pennsylvania -- have breast density notification legislative efforts on tap for 2012.

Real-world concerns

It's all very good to mandate that women be informed of their breast tissue density, but it's not so easy to actually put additional screening such as breast ultrasound in place, Weigert told said. There's additional scheduling, technical factors, physician supervision, and patient logistics that must be addressed.

"Do we call patients back who fulfill the [breast US] criteria, or wait for the referring physician to talk to the patient?" she asked. "Does a radiologist need to be present to review the ultrasound results, or do we bring the patient back if there are questionable findings? How should we file claims for ultrasound screening, since there's no true 'screening' code? How do we incorporate the extra work of producing and sending letters out to women to comply with the law?"

The question of whether the breast ultrasound study is performed by the technologist or the radiologist must be addressed, as well as how many screening ultrasounds can realistically be done in one day and what protocols will be used to determine true findings versus false positives.

As for the future, Weigert predicts automated ultrasound technology will be performed and interpreted as a true screening exam, and breast density will be measured by computer algorithms rather than radiologist interpretation. Weigert also predicts a new screening breast ultrasound billing code, accreditation, and ramped-up data tracking, she said.

View the article online.

Article written by staff at auntminnie.com and adapted for the purposes of this newsletter.

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