G. R. Ruth

New distal embolic protection device the FiberNet® 3 dimensional filter: First carotid human study

Objective: Evaluate the performance and safety of the FiberNet® Embolic Protection System during carotid artery intervention. Background: Carotid Angioplasty and Stenting (CAS) can be proposed to treat the majority of carotid stenoses. Brain embolization takes place and routine use of Embolic Protection Devices (EPD) is warranted. Many EPDs have significant limitations, which may be addressed by a new EPD, the FiberNet® (Lumen Biomedical, Plymouth, MN). Methods: The system consists of a 3‐dimensional expandable filter made of fibers, which expand radially, mounted onto a 0.014″ wire and retrieval catheter. FiberNet can capture particles as small as 40 μm without compromising flow. Results: 35 lesions treated in 34 patients. Male 67.6%. Age: 71.4 ± 8.8 (50–85). Average stenosis 84.5% ± 7.9 (70–99). 29.4% were symptomatic. Technical success: 34/35 (97%). No stroke or death within 30 days. Neurological events: two permanent amaurosis, one amaurosis fugax. All samples visually contained significant amounts of emboli. The mean surface area of debris caught was 63.8 mm2 (37.7–107.5). Comparisons were made with other EPDs. The mean surface area of debris caught was 12.2 mm2 (2.7–34.3). No changes were noted in CT/MRI at 30‐day post procedure. Conclusion: The first human use of this new novel EPD in carotid artery stenting is encouraging. The FiberNet was easy to use and confirmed the ability to capture particles less than 100 μm. The feasibility of the FiberNet has been demonstrated. Additional patients will demonstrate the overall safety and efficacy of this new EPD device.

A novel stop codon mutation (X417L) of the ferrochelatase gene in bovine protoporphyria, a natural animal model of the human disease

Protoporphyria (PP) is caused by a deficiency of ferrochelatase (FC) activity, which catalyzes the final step in the heme biosynthesis pathway. Bovine are the only species other than man with naturally occurring PP. For expression of the PP phenotype, two copies of the mutated gene are necessary in bovine, whereas one copy is sufficient in humans. We report the first potential disease-causing mutation in the bovine FC gene. The coding region of FC was sequenced from the liver tissue of protoporphyric and normal bovine. A transversion was identified at nucleotide position 1250 which changed the stop codon to leucine (TGA-->TTA) in the protoporphyric FC sequence. As a consequence, the mutant protein is predicted to have an additional 27 amino acids. To screen other bovine for the G-->T transversion, cDNAs from liver tissue of clinically and biochemically normal, and from heterozygous and homozygous affected animals were used for allele-specific polymerase chain reaction. Three normal animals had only the G allele, five affected animals had only the T allele, and three heterozygous animals had both the G and T alleles. These results support our hypothesis that this mutation causes PP in bovine.

Evaluation of the Rebound Hernia Repair Device for Laparoscopic Hernia Repair

This investigation of the Rebound Hernia Repair Device found that the device has favorable handling characteristics and may serve as a useful agent in laparoscopic hernia repair.

Perirenal Hemorrhage Syndrome in Market Turkey Toms: Effect of Management Factors

Differences in the overall mortality rates and mortality due to perirenal hemorrhage syndrome (PHS) were compared in large white Nicholas tom turkeys. The study evaluated the effects of 1) four different light and temperature treatments; 2) three feed additives proposed to have anti-stress effects (reserpine, acetylsalicylic acid, and increased calcium); 3) toe-clipping on mortality, various disease conditions, and production parameters. Mortality varied from 0.60% to 3.57% among groups. Increased room temperature (21 C), toe-clipping, step-up/step-down lighting, and dietary reserpine reduced the incidence of PHS as compared with lower room temperature (13 C), no toe-clipping, intermittent lighting (2 hours light, 4 hours dark), and no dietary reserpine. Dietary aspirin or elevated calcium levels had no effect on PHS incidence. Overall mortality was greatest in the warmer rooms.

The incidence of perirenal hemorrhage syndrome in six flocks of market turkey toms.

Four flocks of the Nicholas strain and two of the British United turkey (BUT) strain of large white market turkey toms were monitored from 8 to 19 weeks of age to identify the presence, incidence, age distribution, and possible cause(s) of perirenal hemorrhage syndrome (PHS), or acute hypertensive angiopathy. Mortality rates varied among the flocks from 0.81% to 1.78% of total poults started. Nicholas flocks has a distinct peak in mortality between 9 and 14 weeks of age. PHS was the main cause of mortality from 8 to 14 weeks of age in all flocks except one, and the incidence diminished after 15 weeks of age. No significant bacterial pathogens were detected in any of the PHS cases. Distinct peaks in overall weekly mortality between 10 and 13 weeks of age similar to those in the four Nicholas flocks were also observed in six of 10 Minnesota flocks surveyed separately.

Internal aortic annuloplasty: a novel technique.

ABSTRACT Background: The purpose of this study was to define an experimental model and a reproducible surgical technique for the preclinical assessment of safety and biocompatibility of a novel intra-annular internal aortic annulus repair device. Methods: Adult sheep were implanted with HAART Incs 19 mm aortic annulus repair device via a transverse aortotomy using standard anesthetic, surgical, and cardiopulmonary bypass techniques. Animals were closely monitored throughout the study period until the time of elective sacrifice at 30 or 60 days. Results: Six adult sheep, mean age 63.2 weeks, mean weight 68.8 kg, underwent aortic annuloplasty with a 19 mm annuloplasty frame. Five of the sheep remained stable until scheduled sacrifice. The primary outcome of this study was animal mortality. Early mortality was seen in only one animal (16.7%), due to a surgical complication. Mild-to-moderate aortic insufficiency was observed in all animals upon echocardiographic examination at the time of elective sacrifice. Conclusions: Of the six animals that underwent aortic annuloplasty, there was one early death due to surgical complication. The remaining five subjects were clinically stable at the time of elective sacrifice. Any conclusions regarding the cause of the observed aortic insufficiency are beyond the scope of this feasibility study but would need to be fully evaluated in the preclinical assessment of any internal aortic annuloplasty device. We have shown that we have developed a reproducible surgical technique in a physiologically appropriate model for the preclinical assessment of internal aortic annulus repair devices.

Safety and biocompatibility of the myosplint system - A passive implantable device that alters ventricular geometry for the treatment of heart failure

A passive implantable device developed for the treatment of heart failure, the Myosplint® System, has demonstrated therapeutic efficacy in a canine model of pacing induced heart failure. The current study sought to demonstrate chronic device safety and biocompatibility, in vivo, in a normal porcine model.Two devices were implanted into each normal, beating heart of 6 juvenile and 15 adult pigs without cardiopulmonary bypass. Animals survived 90 (juvenile and adult) or 180 days (adult only). Serial hematologic and biochemical profiles were evaluated in each pig during the study period. A comprehensive necropsy study was performed in each pig to evaluate device stability, healing response, thromboembolism, hemorrhage, and intravascular hemolysis related to the Myosplint system.Six adult animals died from infectious disease (four) or perioperative (two) complications unrelated to device design or function and were excluded from the final analysis. No clinical, biochemical or pathologic evidence of significant, device related adverse events was observed in surviving animals. The chronic myocardial healing response appeared normal at term, and all devices maintained their structural integrity throughout the study.The Myosplint system was easily implanted in beating hearts and was rapidly incorporated into host tissues without clinically significant morbidity in this porcine model.

A chromosomal reciprocal translocation (1q+; 14q−) in a boar siring reduced litter sizes

In our initial cytogenetic surveillance of boars one of 15 was found to be hypoprolific. It averaged 7.1 piglets per litter in over 51 monospermic matings with sows which, with other boars averaged 10.8 piglets per litter. Cytogenetic evaluations revealed only the hypoprolific boar to have an abnormal karyotype, namely {38XY, t(1;14) (q2.12, q2.2)}. This represents a new type of 1;14 reciprocal translocation, and also the first report of a reciprocal translocation for swine in the United States.