Paul Sierzenski

Transcranial ultrasound in clinical sonothrombolysis (TUCSON) trial

Microspheres (μS) reach intracranial occlusions and transmit energy momentum from an ultrasound wave to residual flow to promote recanalization. We report a randomized multicenter phase II trial of μS dose escalation with systemic thrombolysis.

A Pilot Randomized Clinical Safety Study of Sonothrombolysis Augmentation With Ultrasound-Activated Perflutren-Lipid Microspheres for Acute Ischemic Stroke

Background and Purpose— Ultrasound transiently expands perflutren-lipid microspheres (&mgr;S), transmitting energy momentum to surrounding fluids. We report a pilot safety/feasibility study of ultrasound-activated &mgr;S with systemic tissue plasminogen activator (tPA). Methods— Stroke subjects treated within 3 hours had abnormal Thrombolysis in Brain Ischemia (TIBI) residual flow grades 0 to 3 before tPA on transcranial Doppler (TCD). Randomization included Controls (tPA+TCD) or Target (tPA+TCD+2.8 mL &mgr;S). The primary safety end point was symptomatic intracranial hemorrhage (sICH) with worsening by ≥4 NIHSS points within 72 hours. Results— Fifteen subjects were randomized 3:1 to Target, n=12 or Control, n=3. After treatment, asymptomatic ICH occurred in 3 Target and 1 Control, and sICH was not seen in any study subject. &mgr;S reached MCA occlusions in all Target subjects at velocities higher than surrounding residual red blood cell flow: 39.8±11.3 vs 28.8±13.8 cm/s, P<0.001. In 75% of subjects, &mgr;S permeated to areas with no pretreatment residual flow, and in 83% residual flow velocity improved at a median of 30 minutes from start of &mgr;S infusion (range 30 s to 120 minutes) by a median of 17 cm/s (118% above pretreatment values). To provide perspective, current study recanalization rates were compared with the tPA control arm of the CLOTBUST trial: complete recanalization 50% versus 18%, partial 33% versus 33%, none 17% versus 49%, P=0.028. At 2 hours, sustained complete recanalization was 42% versus 13%, P=0.003, and NIHSS scores 0 to 3 were reached by 17% versus 8%, P=0.456. Conclusions— Perflutren &mgr;S reached and permeated beyond intracranial occlusions with no increase in sICH after systemic thrombolysis suggesting feasibility of further &mgr;S dose-escalation studies and development of drug delivery to tissues with compromised perfusion.

A Randomized Controlled Trial of Ultrasound-Assisted Lumbar Puncture

Evidence showing the systematic utility of ultrasound imaging during lumbar puncture (LP) in the emergency department is lacking. Our hypothesis was that ultrasound‐assisted LP would increase the success rate and ease of performing LP with a greater benefit in obese patients.

AIUM practice guideline for the performance of the focused assessment with sonography for trauma (FAST) examination.

The American Institute of Ultrasound in Medicine (AIUM) is a multidisciplinary association dedicated to advancing the safe and effective use of ultrasound in medicine through professional and public education, research, development of guidelines, and accreditation. To promote this mission, the AIUM is pleased to publish, in conjunction with the American College of Emergency Physicians (ACEP), this AIUM Practice Guideline for the Performance of the Focused Assessment With Sonography for Trauma (FAST) Examination. We are indebted to the many volunteers who contributed their time, knowledge, and energy to bringing this document to completion. The AIUM represents the entire range of clinical and basic science interests in medical diagnostic ultrasound, and with hundreds of volunteers, the AIUM has promoted the safe and effective use of ultrasound in clinical medicine for more than 50 years. This document and others like it will continue to advance this mission. Practice guidelines of the AIUM are intended to provide the medical ultra-sound community with guidelines for the performance and recording of high-quality ultrasound examinations. The guidelines reflect what the AIUM considers the minimum criteria for a complete examination in each area but are not intended to establish a legal standard of care. AIUM-accredited practices are expected to generally follow the guidelines with the recognition that deviations from the guidelines will be needed in some cases depending on patient needs and available equipment. Practices are encouraged to go beyond the guidelines to provide additional service and information as needed by their referring physicians and patients.

Safety and dose-escalation study design of Transcranial Ultrasound in Clinical SONolysis for acute ischemic stroke: the TUCSON Trial

Rationale Transcranial Doppler (TCD) monitoring during intravenous tissue plasminogen activator (i.v.-tPA) infusion increases recanalization rates in acute ischemic stroke. Addition of perflutren-lipid microspheres MRX-801 (μS) may further enhance the process of recanalization. This article describes the design of the Transcranial Ultrasound in Clinical SONolysis (TUCSON) trial. Aims and Design TUCSON is a phase I-II, randomized, placebo-controlled, open-label, safety, dose-escalation clinical trial of μS+TCD ultrasound (sonolysis). Patients with acute ischemic stroke and arterial intracranial occlusions are enrolled within 3 h of symptom onset. All patients receive standard i.v.-tPA and will be randomized to 90 min of continuous 2-MHz TCD+μS or 90 min of saline+brief TCD vessel assessments. The safety profile of four escalating dose tiers will be assessed. Arterial occlusions and recanalization are defined with the Thrombolysis in Brain Ischemia flow grades. Study Outcomes Safety is determined by the rates of symptomatic intracerebral hemorrhage within 36 h. Neurological deficits and outcomes are measured with the National Institute of Health Stroke Scale and modified Rankin Scale (mRS). The signal-of-efficacy is determined by rates of recanalization, dramatic or early clinical recovery within 2 h, clinical recovery at 24–36 h and independent outcome (mRS 0–2) at 90 days.

Assessment of Medicare's imaging efficiency measure for emergency department patients with atraumatic headache.

STUDY OBJECTIVE Computed tomography (CT) use has increased rapidly, raising concerns about radiation exposure and cost. The Centers for Medicare & Medicaid Services (CMS) developed an imaging efficiency measure (Outpatient Measure 15 [OP-15]) to evaluate the use of brain CT in the emergency department (ED) for atraumatic headache. We aim to determine the reliability, validity, and accuracy of OP-15. METHODS This was a retrospective record review at 21 US EDs. We identified 769 patient visits that CMS labeled as including an inappropriate brain CT to identify clinical indications for CT and reviewed the 748 visits with available records. The primary outcome was the reliability of OP-15 as determined by CMS from administrative data compared with medical record review. Secondary outcomes were the measures validity and accuracy. Outcome measures were defined according to the testing protocol of the American Medical Associations Physician Consortium for Performance Improvement. RESULTS On record review, 489 of 748 ED brain CTs identified as inappropriate by CMS had a measure exclusion documented that was not identified by administrative data; the measure was 34.6% reliable (95% confidence interval [CI] 31.2% to 38.0%). Among the 259 patient visits without measure exclusions documented in the record, the measures validity was 47.5% (95% CI 41.4% to 53.6%), according to a consensus list of indications for brain CT. Overall, 623 of the 748 ED visits had either a measure exclusion or a consensus indication for CT; the measures accuracy was 16.7% (95% CI 14% to 19.4%). Hospital performance as reported by CMS did not correlate with the proportion of CTs with a documented clinical indication (r=-0.11; P=.63). CONCLUSION The CMS imaging efficiency measure for brain CTs (OP-15) is not reliable, valid, or accurate and may produce misleading information about hospital ED performance.

ACR Appropriateness Criteria Head Trauma—Child

Head trauma is a frequent indication for cranial imaging in children. CT is considered the first line of study for suspected intracranial injury because of its wide availability and rapid detection of acute hemorrhage. However, the majority of childhood head injuries occur without neurologic complications, and particular consideration should be given to the greater risks of ionizing radiation in young patients in the decision to use CT for those with mild head trauma. MRI can detect traumatic complications without radiation, but often requires sedation in children, owing to the examination length and motion sensitivity, which limits rapid assessment and exposes the patient to potential anesthesia risks. MRI may be helpful in patients with suspected nonaccidental trauma, with which axonal shear injury and ischemia are more common and documentation is critical, as well as in those whose clinical status is discordant with CT findings. Advanced techniques, such as diffusion tensor imaging, may identify changes occult by standard imaging, but data are currently insufficient to support routine clinical use. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

Ultrasound Diagnosis of Penile Fracture

BACKGROUND Rupture of the corpus cavernosum, penile fracture, is an uncommon occurrence. Diagnosis is straightforward when classical historical and physical examination findings are present. However, atypical presentations can make the diagnosis difficult. OBJECTIVES Review the literature supporting use of ultrasound for the diagnosis of penile fracture. Review of the ultrasonographic findings in patients with penile fracture. CASE REPORT A 32-year-old man presented with penile ecchymosis after sex but lacking several historical and physical examination elements for a diagnosis of penile fracture. Ultrasound performed by the treating physician revealed rupture of the tunica albuginea and presence of a hematoma, leading to a diagnosis of penile fracture. CONCLUSION Ultrasound is a simple, efficient, and non-invasive imaging method to assist in the diagnosis of penile fracture.

Applications of Justification and Optimization in Medical Imaging: Examples of Clinical Guidance for Computed Tomography Use in Emergency Medicine

Availability, reliability, and technical improvements have led to continued expansion of computed tomography (CT) imaging. During a CT scan, there is substantially more exposure to ionizing radiation than with conventional radiography. This has led to questions and critical conclusions about whether the continuous growth of CT scans should be subjected to review and potentially restraints or, at a minimum, closer investigation. This is particularly pertinent to populations in emergency departments, such as children and patients who receive repeated CT scans for benign diagnoses. During the last several decades, among national medical specialty organizations, the American College of Emergency Physicians and the American College of Radiology have each formed membership working groups to consider value, access, and expedience and to promote broad acceptance of CT protocols and procedures within their disciplines. Those efforts have had positive effects on the use criteria for CT by other physician groups, health insurance carriers, regulators, and legislators.

Summary of Workshop on CT in Emergency Medicine: Ensuring Appropriate Use

This paper addresses the increasing use of CT in medical radiologic imaging, with a focus on applications in emergency medicine. The rapidly increasing use of CT in medical imaging over the past 3 decades has been a major subject in many recent publications, including a discussion of concerns about patient radiation doses, unnecessary CT examinations, and the costs of CT examinations. One area of these concerns has been the use of CT examinations for triage, selection of treatment options, and release of patients from emergency medical settings. On September 23 and 24, 2009, the National Council on Radiation Protection and Measurements held a workshop on appropriate uses of CT imaging with emergency patients. The workshop was cosponsored by 8 private and government organizations: the American Association of Physicists in Medicine, the American College of Emergency Physicians, the ACR, the American Society of Emergency Radiology, the Centers for Disease Control and Prevention, Landauer, Inc, the Society for Academic Emergency Medicine, and the US Environmental Protection Agency. This paper presents a summary of discussions at the workshop and recommendations for important areas of consideration in a subsequent consensus paper to be prepared on clinical guidance for applications of CT in emergency medicine procedures.