Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial.

BACKGROUND: B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. We present the results of the EX-PAD-03 U.S. pivotal trial of the EXIMO B-Laser™. METHODS: EX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. The study enrolled patients in the United States and Europe. The primary efficacy endpoint was the average reduction in residual diameter stenosis of >20% from baseline prior to any adjunctive therapy achieved by the B-Laser™ catheter alone. The primary safety endpoint was freedom from major adverse events (MAEs) defined as: unplanned target limb amputation above the ankle, clinically driven target lesion revascularization (CD-TLR) and cardiovascular related death. RESULTS: A total of 97 subjects (107 lesions) were enrolled. Mean age was 70.5 years and 51% were males. Diabetes mellitus was present in 42.3%. Mean lesion length was 53.96 ±â€¯43.18 mm and 26.2% had severe calcification. Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). The mean percent stenosis at the target lesion as assessed by the Core lab was 85.7% ±â€¯12.2 (femoro-popliteal 85.6 ±â€¯12.8%; tibials 86.0 ±â€¯9.6%). Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ±â€¯14.2% meeting the primary efficacy endpoint goal. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. Per Core lab, there was no device-related distal embolization, dissections that required additional therapy, perforation, or pseudoaneurysm. Bailout stenting was 0.9%. A significant improvement from baseline in ABI (0.24 ±â€¯0.18), Rutherford category (-1.79 ±â€¯1.22) and WIQ (0.26 ±â€¯0.28) were noted at 1 month. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up. CONCLUSION: The Eximo B-Laser™ is effective and safe in ablating atherosclerotic and restenotic tissue for both above and below the knee obstructive arterial disease. The device has a high safety profile including a low risk of distal embolization.

Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-Laser™ IDE study.

BACKGROUND: The B-Laser™ atherectomy system (Eximo Medical, Israel) is a 355 nm solid-state Nd:YAG short pulse laser for de-novo and restenotic infrainguinal PAD with enhanced affinity for atheroma and calcified plaque. METHODS: The study was a prospective, single-arm, multi-center, international, open-label study assessing the B-Laser™ in symptomatic (Rutherford 2 to 4) infrainguinal peripheral artery disease. Primary core lab efficacy was mean reduction in diameter stenosis >20% by the B-Laser™ catheter alone. Cardiovascular death, major amputation, target lesion revascularization, WIQ, ABI and Rutherford class were obtained at baseline and out to 6 months. Duplex ultrasound patency (PSVR <2.5), was evaluated by Core Lab. RESULTS: 97 (77 in USA) PAD subjects (51 male, mean 70.5 years [range 46-86]) with 107 lesions were treated with B-Laser™ (average length 5.4 cm [range 1-24], 29.0% infrapopliteal. 77.6% calcification [26.2% severe], 21.5% chronic total occlusions, 20.6% re-stenotic). Average reduction in residual stenosis post B-Laser™ alone was 33.6 ± 14.2%. Baseline and final stenosis (post laser and adjunctive therapy) were 85.7 ± 12.2% and 17.7 ± 11.0%, respectively. Duplex patency was 96.8% at 30-days and 85.6% at 6 months (95.7% 6-month patency with severe calcification), and did not differ between POBA vs. DCB sub-groups. ABI, Rutherford category and WIQ all improved. There was one MAE and three TLRs out of 101 lesions. No procedural distal embolization was noted and there were no major device-related dissections. CONCLUSIONS: Experience with the B-Laser™ atherectomy system in infrainguinal PAD procedures demonstrates a high level of safety and efficacy for denovo and restenotic infrainguinal arterial lesions.

An obscure case of hepatic subcapsular hematoma.

Spontaneous liver bleeding is often reported in preeclampsia. It is otherwise rare and has been linked to gross anatomical lesions and coagulopathy. We report a case of subcapsular hematoma of the liver without any apparent lesion and in the absence of coagulopathy. A 41-year-old male, paraplegic for 16 years, presented to the emergency department 3 days after sudden onset of right upper quadrant and shoulder pain. He had been on vitamins and 5,000 units subcutaneous heparin 12-hourly at the nursing home for the last month. He was in no distress, afebrile, with stable vitals. Physical examination showed a diverting colostomy, tender hepatomegaly and sacral decubiti. A fecal occult blood test was negative. There was spastic paraplegia below the level of T12. Two days after admission, the patient was afebrile and hemodynamically stable. PTT, PT, liver profile, BUN and creatinine were all normal, however his hemoglobin had dropped from 11.3 to 7.6 g/dl. An abdominal CT scan revealed an isolated 9.0 × 1.8 cm subcapsular hematoma. The patient received blood transfusion in the intensive care unit and was discharged 7 days later. In conclusion, spontaneous liver hemorrhage occurs in the nonobstetrical population in the setting of gross anatomical lesions or coagulopathy. This is the first report of an isolated subcapsular liver hematoma.

Assessing awareness, knowledge and use of folic acid in Kansas women between the ages of 18 and 44 years.

UNLABELLED: Taking folic acid daily, before and during early pregnancy, has been proven to reduce neural tube birth defects (NTD). Unfortunately, many women fail to take it daily as recommended. OBJECTIVES: To assess women's self-reported awareness, knowledge and use of folic acid. Methods Data were obtained by cross-sectional, random digit-dialing, computer-assisted telephone interviews with 250 women in Kansas. Associations were determined by chi-squared analysis. RESULTS: Eighty-eight percent of childbearing age women in Kansas have a general awareness of folic acid, 20% have knowledge that it reduces birth defects, but only 25% report taking it daily. Awareness was associated with high school or greater education (P < .0001), incomes over $25,000 (P = 0.0003), being married (P = 0.0035), being white (P = 0.0135), having health insurance (P = 0.0152) and being capable of pregnancy (P = 0.0119). Knowledge that folic acid reduces birth defects was associated with being aware of the USPHS recommendation (P < .0001), being capable of pregnancy (P = 0.0043), being pregnant (P = 0.0061), and being aware of folic acid (P = 0.0379). Taking folic acid daily was associated with currently being pregnant (P = 0.0126). CONCLUSIONS: Women less likely to take folic acid on a daily basis were young, non-Caucasians who reported less education, less income and no health insurance. Based upon these data, multi-level education campaigns that specifically target lower-SES women should be considered.

Diagnosis of marginal cell lymphoma of small intestine by double balloon enteroscopy.

A 65-year-old woman with a medical history of diabetes mellitus type 2, hypertension, an old cerebrovascular accident, and seizure disorder presented to the emergency room with lower abdominal pain of 4 weeks duration. Upon physical examination, her abdomen was soft and bowel sounds were present, but there was diffuse tenderness in her lower abdomen with some guarding. A computed tomography scan of her abdomen with oral and intravenous contrast showed significantly thickened small bowel loops with subjacent lymphadenopathy. Biopsies obtained during esophagogastroduodenoscopy and colonoscopy showed acute and chronic inflammation. A double balloon enteroscopy (DBE) was then performed, which showed stricture in the jejunum from which the biopsy was obtained. The biopsy showed marginal cell lymphoma. The patient is presently undergoing chemotherapy. Double balloon enteroscopy is a new elegant endoscopical technique that seems promising, as the endoscopist can reach undiscovered small bowel segments. It seems to be well tolerated and safe. For the first time, it provides the means to endoscopically investigate and treat disorders of the small intestine that have previously been inaccessible to conventional endoscopy.