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Influence of microwave radiation on the hematopoietic system, in: Biologic Effects and Health Hazards of Microwave Radiation, Czerski P. Behavioral and thermal effects of microwave radiation at resonant and nonresonant wavelengths, Radio Sci. Biological effects of millimeter waves at spectral singularities, in: Electromagnetic Compatibility, Wydawnictwo Politechniki, Wroclawskiej, Breslau, Poland, pp. Whole body microwave exposure emitted by cellular phones and testicular function of rats, Urol. Whole body exposure of rats to microwaves emitted from a cell phone does not affect the testes, Bioelectromagnetics 24:182?188. The thermal basis for disruption of operant behavior by microwaves in three animal species, in: Microwaves and Thermoregulation, Adair E. Operant behavior and colonic temperature of Macaca mulatta exposed to radio frequency fields at and above resonant frequencies, Bioelectromagnetics 5:233?246. The effects of radiowaves on the growth of animals, in: Biological Effects of Radiofrequency Electromagnetic Fields, Gordon A. Evaluation in humans of the effects of radiocellular telephones on the circadian patterns of melatonin secretion, a chronological rhythm marker, J. Effects of nonionizing electro-magnetic radiation on implantation and intrauterine development of the rat, Ann. Deformity and intrauterine death after short-wave therapy in early pregnancy in experimental animals, Muench. Microwave effects on acetylcholine induced channels in cultured chick myotubes, Bioelectromagnetics 9:363?372. Morphological changes in the central nervous system due to the action of centimeter waves on the organism, Arkh. Dependence of the functional activity of liver mitochondria with super-high frequency radiation, Hyg. Experi mental research on the biological effects of 12-centimeter low-intensity waves, in: Health in Inhabited Localities, 2nd ed. Microwave radiation-induced calcium ion efflux from human neuroblastoma cells in culture, Bioelectromagnetics 5:71?78. Radiofrequency radiation-induced calcium ion efflux enhancement from human and other neuroblastoma cells in culture, Bioelectromagnetics 10:197?202. Dose dependence of acetylcholinesterase activity in neuroblastoma cells exposed to modulated radio-frequency electromagnetic radi ation, Bioelectromagnetics 13:317?322. The acute effects of exposure to the electromagnetic field emitted by mobile phones on human attention, NeuroReport 13:317?322. An attempt to assess the functional state of the cerebral synapses in rabbits exposed to chronic irradiation with microwaves, Acta Physiol. Congenital malformations in the rat following induced hyperthermia during gestation, Teratology 1:173?178. Congenital defects in guinea pigs: fetal resorptions, abortions, and malforma tions following induced hyperthermia during early gestation, Teratology 2:313?328. Survival and cancer in laboratory mammals exposed to radiofrequency energy, Bioelectromagnetics (Suppl. Heating characteristics of laboratory animals exposed to ten centimeter microwaves, U. Mobile phones modulate response patterns of human brain activity, NeuroReport 9:3229?3232. Changes in the state of water induced by radiofrequency electromagnetic fields, Fed. Effect of long term mobile communication microwave exposure on vascular permeability in mouse brain, Pathology 34:344?347. Microwave hearing: evidence for thermoacoustic auditory stimulation by pulsed microwaves, Science 185:256?258. Specific immunity and nonspecific resistance to infection: listeria, protozoa, and viruses in mice and hamsters, J. Effects of microwaves emitted by cellular phones on human slow brain potentials, Bioelectromagnetics 19:384?387. Microwaves emitted by cellular telephones affect human slow brain potentials, Eur.
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Systematic reviews will be complicated by heterogeneity in study design, valve position, and valve types. Other challenges include: whether to include studies of valves no longer marketed that may perform differently from modern valves; accounting for changes in anticoagulation targets and thus the risk for bleeding; and accounting for observational studies that vary by whether outcomes are adjusted for potential confounders. A systematic review that carefully develops a conceptual framework and evaluates the association between intermediate outcomes (such as hemodynamic changes) and long-term outcomes of importance to patients would be particularly useful. Studies of Percutaneous Heart Valves Studies Identified A total of 77 published reports were screened at the full-text stage; of these, 15 were excluded. The remaining 62 publications, describing 55 separate studies, assessed the feasibility and short-term safety of implanting percutaneous heart valves and met our other inclusion 42-103 criteria. Important data from these studies, which represent 856 unique patients, are summarized in Tables 13 and 14; detailed abstractions of the included studies are provided in Evidence Table 2 (see Appendix B). Our gray literature scan identified 12 scientific meeting abstracts that presented data on 104-115 11 studies not described in the published reports. These abstracts, which are summarized in Table 15, report data on 923 patients who underwent percutaneous heart valve replacement. Insufficient evidence was reported in the abstracts to make it possible to determine with confidence how many patients may be represented in more than one abstract, or in both an abstract and a fully published report. Data presented in abstract form at scientific meetings but not yet published in peer-reviewed journals are not included in this information synthesis for the following reasons: (1) meeting abstracts usually contain insufficient information to create sufficiently detailed evidence tables; (2) data presented at scientific meetings often differ from those that later appear in published reports, thereby putting into question the accuracy of the data presented in the abstracts; and (3) information presented at meetings is often derived from a subset of patients whose data have undergone only preliminary analysis. We describe the results from the abstracts we identified briefly in a separate section, below. We identified seven manufacturers of percutaneous heart valves through the published, peer-reviewed medical literature. The first 42 published report of percutaneous valve replacement in an adult involved a valve that was initially manufactured by Percutaneous Heart Valve, Inc. The device is referred to as ?Percutaneous Heart Valve? in the initial published studies. Subsequently, the same device was referred to as the Cribier-Edwards valve in published reports. Reports in the non-peer-reviewed literature describe the Ascendra Aortic Heart Valve Replacement System as the Cribier-Edwards valve for use in transapical, rather than transfemoral, delivery. The second valve to appear in the published literature is the CoreValve ReValving System. The first generation was delivered via a femoral artery approach using a 25 French (Fr) catheter. We identified 22 reports, describing 21studies, that reported on a total of 424 unique patients who underwent percutaneous heart 74,77-97 valve replacement with a CoreValve device. We identified a single published report for each of the five additional percutaneous heart valve manufacturers, plus one case report in which the names of the valve and manufacturer 103 were not reported. A case report of the Paniagua Heart Valve, manufactured by Endoluminal 98 Technology Research, was published in 2005. Case reports of the Lotus Valve (Sadra 99 100 Medical) and the Melody Valve (Medtronic) were published in 2008. A case series that reported on the initial experience of the first 15 patients who received a Direct Flow Medical valve (Direct Flow Medical, Inc. In 2009, a case report was published that involved the Ventor Embracer valve 102 manufactured by Ventor Technologies. Thirty-five of the published reports were case reports, and 27 were case series, the latter representing a total of 822 patients. One study described the procedure and reported clinical outcomes on five patients who underwent a valve in-valve procedure, whereby a CoreValve Revalving device was implanted within a previously 90 implanted prosthetic heart valve in the aortic position. The controls were matched for sex, aortic annulus diameter, left ventricular ejection fraction, body surface area, and body mass index. Interpretation of these findings is complicated, however, by the many potential biases inherent to indirect comparisons between two or more patient populations whose clinical characteristics are significantly different between groups. Five reports described an antegrade approach via the femoral vein, 32 described a retrograde approach via the femoral artery, and 17 described a transapical approach, representing 37, 578, and 223 patients, respectively.
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Observational studies comparing two or more conventional heart valves for valve replacement (continued) Study and status Population and Valve location and Outcomes Notes vis-a-vis systematic follow-up valve comparisons reported reviews Jin, Zhang, Gibson, N: 137 Valve position: Aortic Hemodynamic: 94 et al. Jude Medical Le Tourneau, N: 162 Valve position: Aortic Hemodynamic: Savoye, McFadden, Adult only? Observational studies comparing two or more conventional heart valves for valve replacement (continued) Study and status Population and Valve location and Outcomes Notes vis-a-vis systematic follow-up valve comparisons reported reviews Le Tourneau, N: 150 Valve position: Aortic Hemodynamic: Vinventelli, Fayad, Adult only? Outcomes 15 years after valve for aortic valve replacement: interim results replacement with a mechanical versus a from a prospective randomized trial. J Heart bioprosthetic valve: final report of the Valve Dis 2000;9(2):176-188; discussion Veterans Affairs randomized trial. A five-year postoperative coronary flow more than prospective, randomized comparison. J stented prostheses after valve replacement Thorac Cardiovasc Surg 1977;73(1):43-53. A organization, data collection techniques, three year experience with the Toronto estimates of statistical power, and criteria stentless porcine valve. Twenty year comparison of a Bjork prosthesis: results of a Veterans Shiley mechanical heart valve with porcine Administration cooperative prospective bioprostheses. A comparison of outcomes in valve: results from a subset of a prospective men 11 years after heart-valve replacement randomized trial. The subcoronary Toronto stentless Aortic and mitral valve replacement with versus supra-annular Perimount stented two different disc prostheses. J Cardiovasc Surg hemodynamic results of a randomized (Torino) 1973;Spec No:393-398. A mechanical replacement aortic valves: early prospective randomized comparison of the postoperative hemodynamic function and Mosaic and Perimount bioprostheses in the clinical events. Are stentless valves hemodynamically Mitral valve replacement: randomized trial superior to stented valves? Ann Thorac Surg Ann Thorac Surg 1998;66(3):707-712; 2002;73(3):767-775; discussion 775-778. One year Valve replacement in the small aortic hemodynamic performance of the Perimount annulus: prospective randomized trial of St. Eur J Medtronic Mosaic bioprosthesis in the aortic Cardiothorac Surg 1997;11(3):485-491; position: a prospective randomized study. Do valve replacement: is the stentless xenograft pulmonary autografts provide better an alternative to the homograft? A prospective randomized comparison Stentless versus conventional xenograft of the Medtronic Advantage Supra and St aortic valve replacement: midterm results of Jude Medical Regent mechanical heart a prospectively randomized trial. J Thorac Cardiovasc Surg randomized study comparing the Bjork 2008;136(2):462-471. Peroperative haemodynamic evaluation and Five-year results after randomized mitral early results. Thorac Cardiovasc Surg randomized study comparing Bjork-Shiley 1983;31(4):206-214. A Heart Surgery Forum 2004;7(5):E462-E465; randomized study comparing the Bjork discussion E462-E465. The study comparing the Bjork-Shiley and Monostrut versus Medtronic Hall prosthesis: Lillehei-Kaster disc valves. J CarboMedics and St Jude Medical bileaflet Heart Valve Dis 2000;9(2):308-311; mechanical heart valve prostheses: an discussion 311-312. J Thorac Cardiovasc Surg of thromboembolism with three different 2007;133(3):614-622. CarboMedics supraannular top hat valve improves prosthesis size in the aortic root. Long-term follow-up of morbidity and mortality after aortic valve replacement with 52. Mid-term pattern of survival, hemodynamic Hancock versus stentless bioprosthesis for performance and rate of complications after aortic valve replacement in patients older medtronic freestyle versus homograft full than 75 years.
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