Multicenter Pilot Study of a Serpentine Balloon-Expandable Stent (beStentTM): Acute Angiographic and Clinical Results

The beStent is a new stainless steel, balloon-expandable mesh stent which has a unique serpentine design. Rotation of the unique low stress junctions upon expansion leads to orthogonal locking of the wires, maximizing radial strength and assuring zero shortening. The stent has delineating gold markers which assure precise positioning. We aim to present the initial acute results in a pilot registry for stent evaluation. Two hundred eighty-four stents were used in a total of 217 patients (age 57.9 ± 3.10 years; 178 males; 39 females) in seven centers, for variable indications. Stents of 15-, 25-, and 35-mm length were used. The arteries treated were the left anterior descending (n = 112, 42%), circumflex (n = 54, 20.2%), right coronary (n = 95, 35.5%), left main (n = 1, 0.4%), and vein graft (n = 5, 1.9%). Lesion types were: A in 42 patients (16.5%); B1 in 53 patients (20.7%); B2 in 81 patients (31.8%); and C in 79 patients (31%). One hundred fifty-nine patients required one stent, 40 patients required two stents, and 18 patients required three or more stents. Anticoagulation protocol included procedural heparin with aspirin with/without ticlopidine. Smooth angiographie results were obtained in all cases with no plaque herniation. Acute angiographic success was obtained in 97% of the patients, and acute clinical success in 95% of the patients. Complications within 30 days were: 3 deaths (1.4%) (2 noncardiac); 2 (0.9%) myocardial infarctions; and 2 (0.9%) stent thromboses. Therefore, the beStent is useful in treatment of complex lesions of variable length and complexity, providing excellent acute results with a low complication rate, in spite of unfavorable basic clinical and angiographie characteristics.     

Direct and Telemetered Lead Impedance

Objectives: We undertook this study to determine whether telemetered lead impedance measurements (LIM) can be correlated with direct LIM and to determine the stability of LIM over time when measured directly and via telemetry. Methods: Direct LIM and telemetered LIM were measured in 91 patients; 101 leads during initial implantation and 40 leads during pulse generator replacement. Differences in direct LIM measured during initial implant and pulse generator replacement (direct-direct) were compared in 41 patients (28 atrial leads and 37 ventricular leads). The stability of telemetered LIM obtained immediately postoperatively, at 1 month and 1 year, postimplantation was assessed in 50 patients (23 atrial and 49 ventricular leads). Results: In atrial leads acute direct LIM was 633.9 ± 18.4 Ω versus 575.8 ± 18.5 Ω for telemetered LIM (r = 0.58), and chronic direct LIM was 670.9 ± 49.3 Ω versus 607.0 ± 36.3 Ω for telemetered LIM (r = 0.87). In ventricular leads acute direct LIM was 747.3 ± 16.9 Ω and 684.7 ± 16.4 Ω for telemetered LIM (r = 0.69), and chronic direct LIM was 674.8 ± 29.9 Ω and 625.2 ± 28.5 Ω for telemetered LIM (r = 0.68). The mean direct–direct UM rose 124 Ω (P < 0.001) in atrial leads and 10 Ω (P = NS) in ventricular leads. Telemetered LIM for atrial leads was 581.0 ± 27.6 Ω immediately postimplantation compared to 625.7 ± 34.8 Ω at 1 month and 754.1 ± 43.0 Ω at 1 year. Telemetered LIM for ventricular leads was 661.3 ± 17.5 Ω at implant, 684.6 ± 20.7 Ω at 1 month and 724.7 ± 22.7 Ω at 1 year. Conclusions: There is a good but limited correlation between direct and telemetered LIM. Mean direct LIM obtained at initial implantation is similar to that measured at pulse generator replacement. The telemetered LIM is stable over the first month postimplantation but tends to rise during the first year of follow-up and substantial changes in impedance are not uncommon in individuals with normal function. There is a tendency for LIM to rise with lead maturation. If telemetered LIM is to be followed over time, a baseline telemetered value should be obtained immediately postoperatively.     

Perfluorochemicals as US contrast agents for tumor imaging and hepatosplenography: preliminary clinical results

In animals, perfluorochemicals (PFCs) are effective ultrasound (US) contrast agents that produce hepatic, splenic, and tumor enhancement. The use of Fluosol-DA 20%, an emulsion of perfluorodecalin and perfluorotripropylamine, was studied in nine non-critically ill patients with cancer who had liver lesions. US studies without Fluosol were compared with studies obtained 24, 48, and 72 hours after Fluosol infusion. Vital signs and extensive laboratory analyses are performed before and after Fluosol infusion. Liver metastases from colonic, pancreatic, and gastric carcinoma exhibited rim or diffuse enhancement after a Fluosol dose of 1.6 g/kg or greater. Fluosol produced echogenic enhancement of the liver and spleen relative to kidney at a dose of 2.4 g/kg, allowing the detection of nonenhancing lesions. In addition, Fluosol at a dose of 1.6 g/kg or greater allowed detection of lesions not seen before contrast medium was administered in three of the seven patients studied. There was a mild increase in the level of serum glutamic oxaloacetic transaminase in two patients, one given 2.4 and the other 3.2 g/kg of Fluosol. Mild and transient allergic reactions without change in vital signs were experienced by two patients.     

The structure of human skin collagen as studied with the electron microscope

1. The structure of the collagen fibrils of normal human skin corium has been investigated with the electron microscope. 2. Under the conditions of observation the fibrils ranged in width from about 700 to 1,400 A with 1,000 A as the value occurring most frequently. They showed little tendency to fray longitudinally as is characteristic of tendon fibrils; when fracture of fibrils occurred it was usually in planes transverse to the axis. 3. The axial repeating periods observed in fibrils stained with phosphotungstic acid or shadowed with chromium or platinum range from about 500 to 800 A, the maximum occurring between 620 and 660 A. The average period in fibrils from infant skin does not differ significantly from that of adult and aged skin. 4. Depending on conditions of preparation, intraperiod fine structure, in the form of cross-bands, was observed in varying detail. The most detailed pattern commonly observed contains six bands of characteristic density and position. 5. Shadowed plastic replicas of dried collagen fibrils reproduce much of the structure commonly seen in shadowed fibrils. Replicas of moist fibrils show considerably less surface contouring than do dried fibrils. Replicas from smears of connective tissue fragments on glass show detailed structure, indicating the feasibility of applying this technique to biopsy material. 6. Infant skin differs from adult skin in having considerably greater amounts of amorphous material, little of which is strongly adherent to the collagen fibrils.     

Coralline hydroxyapatite bone graft substitutes: preliminary report of radiographic evaluation

A new bone graft substitute made by conversion of the calcium carbonate exoskeleton of reef-building sea coral into hydroxyapatite has recently become clinically available. The normal radiographic appearance of two forms of this material is described. In the immediate postoperative period, the exoskeletal architecture of these implants is readily appreciated. With graft incorporation over the ensuing months, their intrinsic structure is gradually lost in association with poor marginal definition. Evolving radiographic findings reflect the biocompatible nature of these implants, which provides the potential for ingrowth of native bone with preservation of the coralline scaffold, resulting in enhanced biomechanical properties.