Prospective Multicenter International Registry of Ultrasound-Facilitated Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism (KNOCOUT PE).

BACKGROUND: Prior clinical trials have demonstrated the efficacy of ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk pulmonary embolism (PE) using reduced thrombolytic doses and shorter infusion durations. However, utilization and safety of such strategies in broader PE populations remain unclear. The KNOCOUT PE (The EKoSoNic Registry of the Treatment and Clinical Outcomes of Patients With Pulmonary Embolism) registry is a multicenter international registry designed to study the treatment of acute PE with USCDT, with focus on safety outcomes. METHODS: The KNOCOUT PE prospective cohort included 489 patients (64 sites internationally) with acute intermediate-high or high-risk PE treated with USCDT between March 2018 and June 2020. Principal safety outcomes were independently adjudicated International Society on Thrombosis and Haemostasis major bleeding at 72 hours post-treatment and mortality within 12 months of treatment. Additional outcomes included change in right ventricular/left ventricular ratio and quality of life measures over 12 months. RESULTS: Mean alteplase (r-tPA [recombinant tissue-type plasminogen activator]) infusion duration was 10.5 hours. Mean total r-tPA dose was 18.1 mg, with 31.0% of patients receiving ≤12 mg. Major bleeding events within 72 hours occurred in 1.6% (8/489) of patients. One patient experienced worsening of a preexisting subdural hematoma after USCDT and therapeutic anticoagulation, which ultimately required surgery. All-cause mortality at 30 days was 1.0% (5/489). Improvement in PE quality of life score was observed with a 41.1% (243/489, 49.7%) and 44.2% (153/489, 31.3%) mean relative reduction by 3 and 12 months, respectively. CONCLUSIONS: In a prospective observational cohort study of patients with intermediate-high and high-risk PE undergoing USCDT, mean r-tPA dose was 18 mg, and the rates of major bleeding and mortality were low. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03426124.

Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia.

PURPOSE: To report early findings from a prospective United States clinical trial to evaluate the efficacy and safety of prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: From January 2012 to March 2013, 72 patients were screened and 20 patients underwent treatment. Patients were evaluated at baseline and selected intervals (1, 3, and 6 mo) for the following efficacy variables: American Urological Association (AUA) symptom score, quality of life (QOL)-related symptoms, International Index of Erectile Function score, peak urine flow rate, and prostate volume (on magnetic resonance imaging at 6 mo). Complications were monitored and reported per Society of Interventional Radiology guidelines. RESULTS: Embolization was technically successful in 18 of 20 patients (90%); bilateral PAE was successful in 18 of 19 (95%). Unsuccessful embolizations were secondary to atherosclerotic occlusion of prostatic arteries. Clinical success was seen in 95% of patients (19 of 20) at 1 month, with average AUA symptom score improvements of 10.8 points at 1 month (P < .0001), 12.1 points at 3 months (P = .0003), and 9.8 points at 6 months (P = .06). QOL improved at 1 month (1.9 points; P = .0002), 3 months (1.9 points; P = .003), and 6 months (2.6 points; P = .007). Sexual function improved by 34% at 1 month (P = .11), 5% at 3 months (P = .72), and 16% at 6 months (P = .19). Prostate volume at 6 months had decreased 18% (n = 5; P = .05). No minor or major complications were reported. CONCLUSIONS: Early results from this clinical trial indicate that PAE offers a safe and efficacious treatment option for men with BPH.

Utility of cone-beam CT imaging in prostatic artery embolization.

PURPOSE: To evaluate the utility of cone-beam computed tomography (CT) in patients undergoing prostatic artery (PA) embolization (PAE) for benign prostatic hyperplasia. MATERIALS AND METHODS: From January 2012 to January 2013, 15 patients (age range, 59-81 y; mean, 68 y) with moderate- or severe-grade lower urinary tract symptoms, in whom medical management had failed were enrolled in a prospective United States trial to evaluate PAE. During pelvic angiography, 15 cone-beam CT acquisitions were performed in 11 patients, and digital subtraction angiography was performed in all patients. Cone-beam CT images were reviewed to assess for sites of potential nontarget embolization that impacted therapy, a pattern of enhancement on cone-beam CT suggesting additional PAs, confirmation of prostatic parenchymal perfusion before embolization, and contralateral prostatic parenchymal enhancement. RESULTS: Cone-beam CT was successful in 14 of 15 acquisitions, and PAE was successful in 14 of 15 patients (92%). Cone-beam CT provided information that impacted treatment in five of 11 patients (46%) by allowing for identification of sites of potential nontarget embolization. Duplicated prostatic arterial supply and contralateral perfusion were each identified in 21% of patients (three of 11). Prostatic perfusion was confirmed before embolization in 50% of acquisitions (seven of 14). CONCLUSIONS: Cone-beam CT is a useful technique that can potentially mitigate the risk of nontarget embolization. During treatment, it can allow for the interventionalist to identify duplicated prostatic arterial supply or contralateral perfusion, which may be useful when evaluating a treatment failure.

Geniculate artery embolization in the management of spontaneous recurrent hemarthrosis of the knee: case series.

Spontaneous recurrent hemarthrosis after knee arthroplasty is reported to occur in 0.3%-1% of patients, likely secondary to hypertrophic vascular synovium. Five patients who underwent previous arthroplasty presented with spontaneous hemarthrosis. Selective arterial embolization was performed with spherical embolic particles (diameter range, 100-700 µm). Angiography demonstrated synovial hypervascularity with geniculate artery "tumor blush" appearance in all patients. Average time to resolution of effusion was 2.6 weeks, with no recurrences reported during follow-up (mean, 25.4 mo; range, 16-48 mo). Two patients experienced transient cutaneous ischemia. Selective geniculate artery embolization with spherical embolic particles is an effective treatment for spontaneous recurrent hemarthrosis of the knee.

Uterine artery embolization versus myomectomy: a multicenter comparative study.

OBJECTIVE: To determine whether there is significant quality of life score improvement after uterine artery embolization (UAE) and to compare UAE and myomectomy outcomes. DESIGN: Prospective cohort controlled study. SETTING: Sixteen medical centers in the United States. PATIENT(S): One hundred forty-nine UAE patients and 60 myomectomy patients. Patients were assigned to myomectomy or UAE on the basis of a best treatment decision made by the patient and her physician. All patients were observed for 6 months. The UAE patients also had follow-up examinations at 1 year. INTERVENTION(S): Myomectomy or UAE. MAIN OUTCOME MEASURE(S): Quality of life score changes, menstrual bleeding score changes, uterine size differences, time off, and adverse events. RESULT(S): Both groups experienced statistically significant improvements in the uterine fibroid quality of life score, menstrual bleeding, uterine volume, and overall postoperative quality of life. The mean hospital stay was 1 day for the UAE patients, compared with 2.5 days for the myomectomy patients. The UAE and myomectomy patients returned to their normal activities in 15 days and 44 days, respectively, and returned to work in 10 days and 37 days, respectively. At least one adverse event occurred in 40.1% of the myomectomy patients, compared with 22.1% in the UAE group. CONCLUSION(S): The uterine fibroid quality of life score was significantly improved in both groups. No significant differences were observed in bleeding improvement, uterine volume reduction, uterine fibroid quality of life score improvement, and overall quality of life score improvement between groups. Patients receiving UAE required fewer days off work, fewer hospital days, and experienced fewer adverse events.

I. Uterine fibroid embolization: preprocedure assessment.

Increasing clinical experience with uterine fibroid embolization (UFE) has improved the ability of interventionalist radiologists to discern who is and who is not an appropriate candidate for this procedure. Initial evaluation should be directed at obtaining answers to the following key questions: (1) Does the patient have uterine fibroids that account for her symptoms and are they severe enough to require invasive treatment? (2) Does she desire future childbearing? (3) Are there any clinical indications or imaging signs of uterine malignancy? (4) Are there any medical or anatomic features that would favor a particular therapeutic modality? (5) What are her own preferences regarding treatment? Ultrasound and magnetic resonance imaging are vital elements to the assessment and planning of the appropriate course of action. Given the lack of prospective comparative trials between UFE and surgical treatment, recommendations are often highly influenced by patient preference.

V. Uterine fibroid embolization: management of complications.

Fortunately, the number of complications reported after uterine fibroid embolization (UFE) is extremely low. Angiographic mishap or drug reaction are probably more common than purely UFE-related complications. However, the possibility of infection or necrosis of the uterus, with their significant attendant morbidity, is a sobering reminder that embolotherapy can have a powerful impact on the target organ(s). Knowledge of the expected time course for symptom resolution and the often confusing imaging findings shortly after UFE are critical for avoiding unnecessary delay in surgical intervention or, perhaps more important, an inappropriate rush to surgery when antibiotics alone will suffice. Other complications include alteration of uterine physiology, which may disrupt sexual function, and menstrual irregularity and even premature menopause.

VI. Uterine fibroid embolization: developing a clinical service.

Building a uterine fibroid embolization (UFE) practice can be a complex process. Choices must be made regarding whether to align oneself with a gynecologist or to accept direct referrals. For the interventional radiologist, the responsibilities of evaluation and patient care pose unique and time-consuming administrative and clinical challenges. Physician extenders, either nurse practitioners or physician's assistants, play key roles as clinical coordinators by guiding the patient through the medical system and making certain that she is cleared for the procedure medically and logistically. In some settings, they may also assist in many of the technical aspects of the procedure and postoperative care. Interventional radiologists must be prepared for battles with insurance companies and be willing to go through the appeals process. Business officers must also be trained to properly code for the procedures to insure optimal reimbursement. The success of building a UFE practice may also be bolstered by directly marketing to patients and by providing them with access via the Internet.