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December 10, 2010

 

 

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Life-Saving Therapy for Lung Clots: Reported Study Show Ultrasound Helps Drugs Dissolve Clots Offering Hope to Patients

Ultrasound Sufficient for Evaluating Pediatric Appendicitis

Breast Ultrasound Surveillance Tops Biopsy for Women Under 30

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Life-Saving Therapy for Lung Clots: Reported Study Show Ultrasound Helps Drugs Dissolve Clots Offering Hope to Patients

A new technique that combines the energy of ultrasound with highly targeted delivery of clot-busting drugs appears to be an effective treatment for patients with acute massive pulmonary embolism (PE), commonly referred to as a blood clot in the lung.

The novel treatment is called ultrasound-accelerated catheter-directed thrombolysis (developed by EKOS Corporation, Bothell, Washington). It adds a new dimension to catheter-directed thrombolysis (CDT), a procedure in which a high concentration of clot busting medication is delivered directly to the clot over an extended period of time through an infusion catheter. In ultrasound-accelerated CDT, the infusion catheter includes an element device that emits ultrasound energy in the therapeutic zone; the ultrasound works to make the clot more porous and more penetrable by the thrombolytic agent, thus lessening both the length of time of the infusion and the volume of thrombolytic drug applied.

Reporting on the results of a study of 46 patients treated for massive PE over a ten-year period, Peter Lin, M.D., professor of surgery at the Baylor College of Medicine told attendees at the VEITHsymposium that ultrasound-accelerated CDT achieved complete thrombolysis in 100 percent of the patients treated compared to 67 percent patients receiving CDT without ultrasound. Both the average dose of thrombolytic agent and the length of time for infusion were lower for patients receiving ultrasound-accelerated CDT. Furthermore, there were no hemorrhagic complications within this group compared to 3 incidents in the CDT group. All patients receiving ultrasound-accelerated CDT were treated with tissue plasminogen activator (tPA) as the thrombolytic agent. tPA was administered in 16 of the 21 patients undergoing CDT, with urokinase as the thrombolytic for the other five.

Dr. Lin lauded “while both CDT and ultrasound-accelerated therapy have remarkable therapeutic effects for this life threatening condition, the EKOS device provides a significant added benefit of clearing most if not all the clot while using less drug.” PE accounts for more than 300,000 deaths every year in the United States, and most of these are the result of acute massive PE and typically occur within one hour of presentation. For patients with hemodynamic instability from massive PE, systemic thrombolysis is considered to be the standard of care.

“In institutions with appropriate clinical expertise,” Dr. Lin said, “ultrasound-accelerated thrombolytic is a beneficial treatment option in patients who have acute massive PE with contraindications to systemic thrombolysis, when time to administer systemic thrombolytic agents is lacking, or when no improvement follows stand intravenous thrombolytic administration.”

View the article online

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

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Ultrasound Sufficient for Evaluating Pediatric Appendicitis

Point-of-care ultrasound conducted by emergency medicine physicians may be a useful screening tool for evaluating acute appendicitis in children, according to research from Newark Beth Israel Medical Center in New Jersey.

The research team found that point-of-care ultrasound yielded 85% accuracy for evaluating appendicitis and can be a useful adjunct to clinical evaluation, according to Adam Sivitz, MD, director of pediatric emergency medicine education at Newark Beth Israel Medical Center. He presented the findings at the American College of Emergency Physicians (ACEP) Research Forum.

Acute appendicitis produces 80,000 cases a year and is the most common abdominal surgical emergency in children. Due to concerns over radiation exposure in children, ultrasound is the recommended first-line imaging modality for evaluating acute appendicitis, Sivitz said. Sivitz noted that clinical scoring models for ruling out appendicitis have been published to help stage the order of imaging, placing ultrasound before CT.

"However, these models have ignored the obvious trend in emergency medicine to utilize point-of-care ultrasound, which is now part of emergency medicine resident curriculum and even beginning to get taught at the medical school level," Sivitz told AuntMinnie.com.

"Many people in [emergency medicine] who regularly do ultrasound have been anecdotally looking at the right lower quadrant, and a few places have published manuscripts or abstracts for this in the adult population," he said. "We think that children would benefit the most from [right lower quadrant] point-of-care ultrasound because of a more ultrasound-friendly body habitus and the greater risks associated with radiation exposure in childhood."

Seeking to determine the accuracy of emergency physician bedside ultrasound for suspected appendicitis in children, the research team is conducting a prospective observational study at an urban, academic pediatric emergency department. The study includes patients ages newborn to 21, who presented to the pediatric emergency department with a clinical suspicion for acute appendicitis and had received an order for a radiology ultrasound, CT, or surgical consult. Of the 67 patients included in the study so far, 67% were male. The average age was 11.7 years, with a range of 4.1 to 20.9 years.

Patients were excluded if they had prior abdominal surgery, an inability to tolerate the examination, or a prior definitive imaging study, according to the researchers. Ultrasound-trained emergency medicine physicians or pediatric emergency physicians used an M-Turbo (SonoSite, Bothell, WA) scanner with 10-5 MHz or 5-2 MHz curved-array probes to perform the point-of-care ultrasound studies, and the digital images and video were recorded for review. One hour of didactic training and hands-on training was provided.

A 100-mm visual analog scale (VAS) was used to provide the clinical likelihood score for appendicitis and also for the ultrasonographer's confidence in their findings. All interpretations were recorded at the time of examination, according to the researchers.

Findings were later compared with radiology results. For the purposes of the study, surgical pathology was used as the gold standard for diagnosis of acute appendicitis.

The researchers followed up normal cases by searching electronic medical records and by a phone call no earlier than one week after discharge.

Of the 67 patients, 28 (42%) had pathology-proven appendicitis. The emergency medicine physician was able to visualize the appendix in 56% of the cases. Overall accuracy was 85%, with 82% sensitivity and 87% specificity, Sivitz said. The positive likelihood ratio was 6.4, with a range of 2.8 to 14.8, and the negative likelihood ratio was 0.2, with a range of 0.09 to 0.45.

That performance was pretty good, considering they're not radiologists, Sivitz said. And every ultrasonographer -- Sivitz, two other emergency medicine attendings, and six pediatric emergency medicine fellows -- were new to performing these appendicitis scans, he said. "Our accuracy was actually better than the radiology ultrasound," he said.

The main implication of the study will be that emergency medicine physicians do not always need labs or a surgical consultation, or to wait for radiology, if a patient is suspected of having acute appendicitis, Sivitz said.

"Just like with free fluid in blunt abdominal trauma, gallstones, intrauterine pregnancy, pericardial effusions, or cardiac standstill, once you see it is positive, you are done with the workup," Sivitz said. "We would like to create a relationship with the surgeons and radiologists where our findings are part of the overall process, i.e., if the ultrasound study is obviously positive, then the surgeons go to the OR [like focused abdominal sonography in trauma (FAST) studies]."

The researchers are continuing to enroll patients in the study and are adding more junior sonographers. Sivitz said the next step is to look at outcomes findings such as potential time and resource savings, as well as the level of training needed to gain proficiency.

View the article online

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

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Breast Ultrasound Surveillance Tops Biopsy for Women Under 30

Women younger than 30 years of age with focal breast signs or symptoms can be safely and accurately followed using targeted ultrasound surveillance, according to a study published in the December issue of American Journal of Roentgenology.

The American College of Radiology Appropriateness Criteria recommends ultrasound as the first study for young women, except those at high risk, with focal signs or symptoms, and the model is widely used. However, few outcomes data exist to validate the model.

“Questions remain regarding the accuracy of ultrasound and the need for concurrent mammography in this patient population,” according to Vilert A. Loving, MD, of Seattle Cancer Care Alliance and the department of radiology at University of Washington Medical Center in Seattle, and colleagues.

Loving and colleagues sought to assess the accuracy of ultrasound as a primary imaging study for malignancy detection in women younger than 30 with focal breast signs or symptoms and to evaluate its safety as short-term follow-up for symptomatic lesions characterized as probably benign.

The researchers reviewed electronic records to retrospectively identify all breast ultrasound studies performed at the center between Jan. 1, 2002 and Aug. 30, 2006, in women younger than 30 years. From this group, Loving and colleagues identified 830 women presenting with focal breast signs or symptoms, excluding high-risk women and those with a known cancer or lesion identified at an outside facility.

When radiologists characterized a lesion as BI-RADS category 1 or 2 on the initial ultrasound exam, they did not recommend additional imaging or tissue sampling. They recommended ultrasound-guided core needle biopsy for BI-RADS category 4 or 5 lesions.

Radiologists offered women with BI-RADS category 3, probably benign, lesions several options: ultrasound surveillance at 6, 12 and 24 months; core needle biopsy or surgical excision. The researchers determined benign and malignant outcomes by biopsy and 24 months of follow-up imaging. They also checked the regional tumor registry for at least 24 months to locate malignancies diagnosed at other medical institutions. Any invasive carcinoma or ductal carcinoma in situ was characterized as malignant.

The study cohort comprised 1,091 lesions in 830 women (mean age, 24 years), who underwent 865 ultrasound exams. Radiologists assessed 526 women with BI-RADS category 1 or 2 lesions. The BI-RADS assessment was category 3 in 140 patients, reported Loving and colleagues. Twenty-two women completed 24 months of follow-up ultrasound surveillance, and all were stable and benign. Forty-six women elected to undergo biopsy, and 72 women did not complete imaging or surgical follow-up. Researchers noted no malignancies in any lesion assessed as BI-RADS category 3.

One hundred sixty-three patients were assessed with BI-RADS category 4 lesions, with 155 women undergoing biopsy and two women diagnosed with malignant lesions. The single category 5 lesion was diagnosed as malignant via biopsy. Overall sensitivity of targeted ultrasound was 100 percent, and specificity was 80.5 percent. Loving and colleagues noted that the results suggest that targeting mammography to “highly suspicious cases is a safe practice in this patient population.” The researchers added, ”Surveillance has advantages over biopsy because of its lower morbidity.”

The authors identified several limitations to the study. Specifically, the retrospective single-site study employed radiologists specializing in breast imaging to perform the ultrasound exams. They suggested that additional studies should be performed to determine whether the results are generalizable to other practice settings. The low patient compliance rate with recommended surveillance presented a source of concern, and the authors recommended further efforts to improve compliance.

The incidence of breast malignancy was 0.4 percent in the study of women younger than 30 years, reported Loving and colleagues, who added that finding no malignancies in women with probably benign lesions supports “ultrasound surveillance as a safe alternative to tissue sampling in this setting.”

View the article online

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

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NewsWire. Copyright 2010.  American Registry for Diagnostic Medical Sonography. The ideas and opinions expressed herein do not necessarily reflect those of ARDMS.

 

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