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Catatonia Catatonia is a clinical syndrome symptoms vitamin d deficiency cheap duricef 250mg overnight delivery, rst described by Kahlbaum (1874) symptoms gluten intolerance buy duricef 500mg free shipping, character ized by a state of unresponsiveness but with maintained medications like gabapentin buy duricef 250 mg without prescription, immobile symptoms urinary tract infection discount duricef on line, body posture (sitting, standing; cf. After recovery patients are often able to recall events which occurred during the catatonic state (cf. Kraepelin classied catatonia as a subtype of schizophrenia but most cata tonic patients in fact suffer a mood or affective disorder. Furthermore, although initially thought to be exclusively a feature of psychiatric disease, catatonia is now recognized as a feature of structural or metabolic brain disease (the original account contains descriptions suggestive of extrapyramidal disease): 75 C Cauda Equina Syndrome • Psychiatric disorders: Manic depressive illness; Schizophrenia. Various subtypes of catatonia are enumerated by some authorities, including • Retarded catatonia (Kahlbaum’s syndrome); • Excited catatonia (manic delirium, Bell’s mania); • Malignant catatonia, lethal catatonia: also encompasses the neuroleptic malignant syndrome and the serotonin syndrome; • Periodic catatonia. Cross References Abulia; Akinetic mutism; Imitation behaviour; Mutism; Negativism; Rigidity; Stereotypy; Stupor Cauda Equina Syndrome A cauda equina syndrome results from pathological processes affecting the spinal roots below the termination of the spinal cord around L1/L2, hence it is a syndrome of multiple radiculopathies. Depending on precisely which roots are affected, this may produce symmetrical or asymmetrical sensory impairment in the buttocks (saddle anaesthesia; sacral anaesthesia) and the backs of the thighs, radicular pain, and lower motor neurone type weakness of the foot and/or toes (even a ail foot). Weakness of hip exion (L1) does not occur, and 76 Central Scotoma, Centrocaecal Scotoma C this may be useful in differentiating a cauda equina syndrome from a conus lesion which may otherwise produce similar features. Sphincters may also be involved, resulting in incontinence, or, in the case of large central disc herniation at L4/L5 or L5/S1, acute urinary retention. Causes of a cauda equina syndrome include • Central disc herniation; • Tumour: primary (ependymoma, meningioma, Schwannoma), metastasis; • Haematoma; • Abscess; • Lumbosacral fracture; • Inammatory disease. The syndrome needs to be considered in any patient with acute (or acute on chronic) low back pain, radiation of pain to the legs, altered perineal sensation, and altered bladder function. Missed diagnosis of acute lumbar disc herniation may be costly, from the point of view of both clinical outcome and resultant litigation. Cauda equina syndrome secondary to lumbar disc herniation: a meta analysis of surgical outcomes. Cross References Bulbocavernosus reex; Foot drop; Incontinence; Radiculopathy; Urinary retention Central Scotoma, Centrocaecal Scotoma these visual eld defects are typical of retinal or optic nerve pathology. Examination for a concurrent contralateral superior temporal defect should be undertaken: such junctional scotomas may be seen with lesions at the anterior angle of the chiasm. Broadly speaking, a midline cerebellar syndrome (involving the ver mis) may be distinguished from a hemispheric cerebellar syndrome (involving the hemispheres). Their clinical characteristics are as follows: • Midline cerebellar syndrome: Gait ataxia but with little or no limb ataxia, hypotonia, or nystag mus (because the vestibulocerebellum is spared), or dysarthria; causes include alcoholic cerebellar degeneration, tumour of the midline. The Croonian lectures on the clinical symptoms of cerebellar disease and their interpretation. Cross References Asynergia; Ataxia; Dysarthria; Dysdiadochokinesia; Dysmetria; Hemiataxia; Hypotonia, Hypotonus; Nystagmus Chaddock’s Sign Chaddock’s sign, or the external malleolar sign, is a variant method for elic iting the plantar response, by application of a stimulus in a circular direction around the external malleolus, or the lateral aspect of the foot, moving from heel to little toe. Extension of the hallux (upgoing plantar response, Babinski’s sign) is pathological, indicating corticospinal tract (upper motor neurone) pathology. There is trophic change, with progressive destruction of articu lar surfaces with disintegration and reorganization of joint structure. Cross References Analgesia; Main succulente Charles Bonnet Syndrome Described by the Swiss naturalist and philosopher Charles Bonnet in 1760, this syndrome consists of well formed (complex), elaborated, and often stereotyped visual hallucinations, of variable frequency and duration, in a partially sighted (usually elderly) individual who has insight into their unreality. Predisposing visual disorders include cataract, macular degeneration, and glaucoma. There are no other features of psychosis or neurological disease such as dementia. Reduced stimula tion of the visual system leading to increased cortical hyperexcitability is one possible explanation (the deafferentation hypothesis), although the syndrome may occasionally occur in people with normal vision. Functional magnetic res onance imaging suggests ongoing cerebral activity in ventral extrastriate visual cortex. Pharmacological treatment with atypical antipsychotics or anticonvulsants may be tried but there is no secure evidence base. Complex visual hallucinations in the visually impaired: the Charles Bonnet syndrome. Tay–Sachs disease: Tay’s sign); • Metachromatic leucodystrophy; • Niemann–Pick disease (especially type A). Storage of sphingolipids or other substances in ganglion cells in the perimac ular region gives rise to the appearance. Cross Reference Winging of the scapula Chorea, Choreoathetosis Chorea is an involuntary movement disorder characterized by jerky, restless, pur poseless movements (literally dance like) which tend to it from one part of the body to another in a rather unpredictable way, giving rise to a dgety appear ance. There may also be athetoid movements (slow, sinuous, writhing), jointly referred to as choreoathetosis. Severe proximal choreiform movements of large amplitude (‘inging’) are referred to as ballism or ballismus. When, as is often the case, such movements are conned to one side of the body they are referred to as hemichorea–hemiballismus. There may be concurrent abnormal muscle tone, 80 Chorea, Choreoathetosis C either hypotonia or rigidity. Hyperpronation of the upper extremity may be seen when attempting to maintain an extended posture. The pathophysiology of chorea (as for ballismus) is unknown; movements may be associated with lesions of the contralateral subthalamic nucleus, caudate nucleus, putamen, and thalamus. One model of basal ganglia function suggests that reduced basal ganglia output to the thalamus disinhibits thalamic relay nuclei leading to increased excitability in thalamocortical pathways which passes to descending motor pathways resulting in involuntary movements. Hypernatraemia or hyponatraemia, hypomagnesaemia, hypocal caemia; hyperosmolality; Hyperglycaemia or hypoglycaemia; Non Wilsonian acquired hepatocerebral degeneration; Nutritional. Where treatment is necessary, antidopaminergic agents such as dopamine receptor antagonists. Chronic neuroleptic use may also cause chorea, but these movements are repetitive and predictable, unlike ‘classic’ chorea. Luria claimed it was associated with deep seated temporal and temporo diencephalic lesions, possibly right sided lesions in particular. It occurs in some patients with Alzheimer’s disease who get up and dress, make tea, or phone rela tives in the small hours, oblivious to the actual time, much to the exasperation of their loved ones. Cross Reference Agnosia Chvostek’s Sign Chvostek’s sign is contraction of facial muscles provoked by lightly tapping over the facial nerve as it crosses the zygomatic arch. Chvostek’s sign is observed in hypocalcaemic states, such as hypoparathyroidism and the respiratory alkalo sis associated with hyperventilation. There may be concurrent posturing of the hand, known as main d’accoucheur for its resemblance to the posture adopted for manual delivery of a baby. The pathophysiology of this mechanosensitivity of nerve bres is uncertain, but is probably related to increased discharges in central pathways. Although hypocalcaemia might be expected to impair neuromuscular junction transmis sion and excitation–contraction coupling (since Ca2+ ions are required for these processes) this does not in fact occur. Cross References Main d’accoucheur; Spasm 83 C Ciliospinal Response Ciliospinal Response the ciliospinal response consists of rapid bilateral pupillary dilatation and palpe bral elevation in response to a painful stimulus in the mantle area, for example, pinching the skin of the neck. Cross Reference Pupillary reexes Cinematic Vision Cinematic vision is a form of metamorphopsia, characterized by distortion of movement with action appearing as a series of still frames as if from a movie. Cross Reference Metamorphopsia Circumlocution Circumlocution may be used to refer to: • A discourse that wanders from the point, only eventually to return to the original subject matter, as seen in uent aphasias. Since the clasp knife phenomenon is a feature of spasticity, the term ‘clasp knife rigidity’ is probably best eschewed to avoid possible confusion. Cross References Rigidity; Spasticity Claudication Claudication (literally limping, Latin claudicatio) refers to intermittent symp toms of pain secondary to ischaemia. Claudication of the jaw, tongue, and limbs (especially upper) may be a feature of giant cell (temporal) arteritis. Jaw 84 Clonus C claudication is said to occur in 40% of patients with giant cell arteritis and is the presenting complaint in 4%; tongue claudication occurs in 4% and is rarely the presenting feature. Presence of jaw claudication is one of the clinical features which increases the likelihood of a positive temporal artery biopsy. Claw Foot Claw foot, or pied en griffe, is an abnormal posture of the foot, occurring when weakness and atrophy of the intrinsic foot muscles allows the long exors and extensors to act unopposed, producing shortening of the foot, heightening of the arch, exion of the distal phalanges and dorsiexion of the proximal pha langes (cf. Cross Reference Pes cavus Claw Hand Claw hand, or mainengriffe, is an abnormal posture of the hand with hyperex tension at the metacarpophalangeal joints (fth, fourth, and, to a lesser extent, third nger) and exion at the interphalangeal joints. This results from ulnar nerve lesions above the elbow, or injury to the lower part of the brachial plexus (Dejerine–Klumpke type), producing wasting and weakness of hypothenar mus cles, interossei, and ulnar (medial) lumbricals, allowing the long nger extensors and exors to act unopposed.
Regular intake of a non opioid analgesic other sics combine non opioid analgesics with opioids facial treatment cheap duricef 500 mg without prescription, butal than paracetamol or non steroidal anti inamma bital and/or caeine treatment 4 letter word best purchase for duricef. Regular intake of any combination of ergotamine medications covered by blue cross blue shield buy duricef uk, 1 overuse headache triptans symptoms to diagnosis duricef 500 mg, non opioid analgesics and/or opioids on 1 B. The drugs or drug classes should be specied in Description: Headache developing within 24 hours after parenthesis. Without overuse of any single drug or drug class alone for more than two weeks, which has been interrupted. Caeine consumption of >200 mg/day for >2 Diagnostic criteria: weeks, which has been interrupted or delayed C. Comment: Patients who are clearly overusing multiple medications for acute or symptomatic treatment of 8. While a prospective diary record over several daily consumption of opioid(s) for more than three weeks might provide the information, it would also months, which has been interrupted. International Headache Society 2018 126 Cephalalgia 38(1) contraception or following a course of replacement or Bibliography supplementary oestrogen). It resolves spontaneously within three days in the absence of further consumption. Headache or migraine fullling criterion C induced spasm of cerebral blood vessels. Evidence of causation demonstrated by both of induced headache in patients with chronic tension the following: type headache. Medical complications of ruption in chronic use of or exposure to a medication or cocaine abuse. Headache in the use and withdrawal of opiates and other associated Diagnostic criteria: substances of abuse. Increase in plasma calcitonin gene related peptide from the extra Comments: It has been suggested, but without sucient cerebral circulation during nitroglycerin induced clus evidence, that withdrawal from chronic use of the fol ter headache attack. Unmasking continuous intravenous infusion of histamine, clin latent dysnociception in healthy subjects. Safety of a tertiary headache centre — clinical characteristics long term doses of aspartame. Analgesic agent m chlorophenylpiperazine induced migraine induced chronic headache: long term results of with attacks: a controlled study. The conrmation ergotamine overuse and drug induced headache: a of a biochemical marker for women’s hormonal clinicoepidemiologic study. The eects of pathways and national distribution of painkillers norethisterone in postmenopausal women on oes in a descriptive, multinational, multicenter study. Inappropriate primary headaches during hormone replacement use of sumatriptan: population based register and therapy. International Headache Society 2018 128 Cephalalgia 38(1) heroin, cocaine and amphetamine users. Comparative with medication overuse: the Akershus study of abuse liability of codeine and naratriptan. Caeine Brief intervention for medication overuse headache as an analgesic adjuvant. J Neurol Neurosurg Psychiatry 2015; 86: 505– of a biochemical marker for women’s hormonal 512. Withdrawal tion overuse headache, follow up after 6 months: a syndrome after the double blind cessation of caf pragmatic cluster randomised controlled trial. The role of estradiol withdrawal in the Limmroth V, Katsarava Z, Fritsche G, et al. Analgesic kers switched from ordinary to decaeinated coee: rebound headache in clinical practice: data from a a 12 week double blind trial. When a pre existing headache with the characteris meningitis or meningoencephalitis tics of a primary headache disorder becomes 9. Headache attributed to infection (or one of its parasitic infection types or subtypes) should be given, provided that 9. The purpose is to distinguish and keep tions of the head (such as ear, eye and sinus infections) separate two probably dierent causative mechanisms are coded as types or subtypes of 11. More rarely, it may accompany other sys the triad of headache, fever and nausea/vomiting is temic infections. In intracranial infections, headache is usually the the probability is increased when lethargy or convul rst and the most frequently encountered symptom. International Headache Society 2018 130 Cephalalgia 38(1) and associated with focal neurological signs and/or B. Bacterial meningitis or meningoencephalitis has altered mental state and a general feeling of illness been diagnosed and/or fever should direct attention towards an intra C. Evidence of causation demonstrated by at least cranial infection even in the absence of neck stiness. An infection, or sequela of an infection, known to a) holocranial be able to cause headache has been diagnosed b) located in the nuchal area and associated C. Evidence of causation demonstrated by at least with neck stiness two of the following: D. It may A variety of bacteria may cause meningitis and/or develop in a context of mild u like symptoms. It is encephalitis, including Streptococcus pneumoniae, typically acute and associated with neck stiness, Neisseria meningitidis and Listeria monocytogenes. The nausea, fever and changes in mental state and/or immunologic background is very important because other neurological symptoms and/or signs. Direct stimulation of the sensory terminals located Diagnostic criteria: in the meninges by the bacterial infection causes the onset of headache. Headache of any duration fullling criterion C iators of inammation such as bradykinin, prostaglan dins and cytokines and other agents released by! Bacterial meningitis or meningoencephalitis has induce pain sensitization and neuropeptide release. Headache has persisted for >3 months after may also play a role in causing headache. Viral meningitis or encephalitis has been attributed to bacterial meningitis or meningoence diagnosed phalitis, and criterion B below C. Bacterial meningitis or meningoencephalitis b) located in the nuchal area and associated 1 remains active or has resolved within the last three with neck stiness months D. Intracranial fungal or other parasitic infection has Diagnostic criteria: been diagnosed C. Neuroimaging shows enhancement of the lepto to the onset of the intracranial fungal or other meninges exclusively. There may also be associated leptomeningeal parallel with the level of immunosuppression. Comments: Pain is usually diuse, with the focus in fron tal and/or retro orbital areas, severe or extremely severe Comments: 9. The India ink test Diagnostic criteria: enables staining of the capsule of cryptococcus. Any headache fullling criterion C encephalon are almost exclusively observed in immuno B. A localized brain infection has been demonstrated depressed patients or old people. More specically, the by neuroimaging and/or specimen analysis following groups are at risk: C. Evidence of causation demonstrated by at least two of the following: 1) people with signicant neutropaenia (<500 neutro 1. Aspergillus) and protozoa Description: Headache caused by and occurring in asso. Brain granulomas have been associated with cyster Diagnostic criteria: cosis, sarcoidosis, toxoplasmosis and aspergillosis. Headache of any duration fullling criterion C localized brain infection include direct compression, irri B. Evidence of causation demonstrated by at least meningeal irritation and increased intracranial pressure. These conditions are mostly dominated by fever, general malaise and other systemic symptoms. When systemic infection is accompanied by meningitis or encephalitis, any head Diagnostic criteria: ache attributed to the infection should be coded to these disorders as a subtype or subform of 9.
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They are mentioned nine times in the decrees and usually differentiated between male and female symptoms of flu buy duricef no prescription. The medical texts often mention the spirits of the dead in conjunction with the gods as both used the same indirect methods to symptoms pancreatitis order duricef 500mg without prescription disease an individual medications list template discount duricef 500mg on line, namely their influence 72210 treatment cheap duricef 250mg amex, shadow, and semen. The fact that the medical texts protect against the semen of both male and female dead further suggests that the female dead maintain their regenerative abilities after their gender transformation in death (Cooney 2010). Pain and suffering itself was a sign of the attempts of the dead and other disease agents to force their way into the body and use their secretions to infect it. You have said that you would strike a blow in this head of his in order to force your entry into this vertex of hisRetreat, recede for the striking power of this burning eye of his. It will ward off your striking power, it will dispel your ejaculation (aAa), your seeds (mtw. In this example, the dead and enemies of the patient are actively choosing to attack the head of the individual, and if they successfully create an opening, they can infect their 44 the Axw are often referred to as the blessed dead vs. Thus, even actions that attack the outside of the body may have been intended to create internal contamination. Leiden I 371), also demonstrate that the Egyptians needed to appeal to the will of the dead directly in order to stop them from causing illness. This list varies considerably between texts, and few of the diseases can be positively identified. This passage suggests that illness could not only occur from external sources, such as aAa or disease demons, but also could manifest internally. The differentiation between the external and internal cause of illness is further outlined in case eight, gloss D of P. Additional texts on illness show us that illness manifests inside the body as undigested food that can become diseased feces and travel outward from the stomach (P. These feces do not only pollute the body, but can create blockages within the stomach and can spread to the heart (P. These feces develop when food remains undigested in the stomach: nn49 jw pw n wHm tm rdj wHm=f, “It is inertness of food. The food appears to be decaying inside the body, thus creating a block within the stomach that can then be spread throughout the body via the mtw. Similarly, if the process of digestion is somehow reversed (an, turning around50), feces can infect the mtw and thus spread disease around the body. Consequently, while food can result in internal contamination, it does not introduce the contamination in the body on its own; it requires that the body, through aberrant actions such as reversals or blockages, disease itself. The most convincing translations of this passage are from Bardinet (Bardinet 1995, 500) and Westendorf (1998, 720), who translate jn as a non enclitic particle, while n is used to negate. This emphasizes the fact that, regardless of its source, the disease is from outside rather than being created by the body itself. The concepts of contamination and pollution within the body are defined and discussed by Douglas (1966) in her anthropological research on ritual acts of purification. Douglas argues that the boundaries of the body become liminal at the orifices where bodily secretions can both represent the self and simultaneously be considered pollutants. Orifices are as well points of entry for foreign contaminants from outside the boundaries of the body. This introduction of the foreign inside the body thus contaminates it, and it becomes necessary to remove the foreign pollutants in order to return the body to its natural and pure state. The above analysis of the Oracular Amuletic Decrees and medical texts demonstrate that in Egyptian thought, the body can be contaminated by a foreign substance that then is adulterated by the body itself. The body could improperly digest food, for example, which causes blockages and introduces pollution into the body via the mtw channels. These pollutants can then manifest into worms—animated representations of this contamination that were not only present figuratively, but probably quite literally in the stool of sick individuals infected with parasites. One could also be contaminated by the secretions of others—poisonous substances which enter from outside the body, infect the mtw channels, and spread primarily to two key places in the body: the stomach and heart. This external poisoning is unambiguously documented by charms to protect against the poison (mtw. This poisonous semen was introduced by deities and the dead, allowing them to infect their victims through malevolent attacks on the body itself. Thus, some ailments, such as headaches, represent attacks designed to contaminate the body. The individuals could also be contaminated by malignant beings themselves: the disease demons. These small bands of disease carrying organisms are associated with the wind and water, and could thus be inhaled or consumed. Once in the belly or stomach of an individual, they could contaminate the rest of the body, just like the other substances discussed above. The disease demons thus simultaneously represent the agency of disease and the substance of its transmission. The disease demons, gods, and even worms that are born from contamination are all independent animated beings, and thus capable of independent agency in contaminating. This independence is critical when considering strategies for removing or destroying illness. While all disease thus appears to be based on contamination, the separation of internal vs. The interior pollutants often manifest as digestive disorders, as the onset of the illness is usually associated with an irregularity in the stomach or stool. Exterior pollutants, on the other hand, were more likely representative of infectious diseases. In this sense, Egyptian theory of external diseases—the introduction of disease causing substances and organisms into the body—is founded upon the concept of infection. I am not attempting to argue that contamination theory includes an understanding of 55 the biological mechanisms of infectious disease, nor that it was a precursor to germ theory, but rather that its similarity to popular depictions of germ theory betray how ancient Egyptian notions regarding disease and medicine are neither outlandish nor unfamiliar in the modern world. Modern commercials for medicinal products depicting illnesses as infective monsters, attacking and forcibly entering the body, attest to these similarities. Advertisements for Lamisil anti fungal cream (“Lamisil” 2014) show a demonic, fiery dermatophyte breaking its way into the nail bed. Those for Mucinex (“#BlameMucus” 2014) show a family of mucus monsters, who are forced to ‘move out’ of their host by the medication. While some scholars would argue that emic Egyptian ideas about disease demons or other invisible divine beings as contaminants are illogical (David 2004), these parallels to modern, popular representations show that they are not far removed from popular depictions of modern germ theory. Previous scholars have attempted to distinguish differences between medicine—described as a practical application of rational treatment—from its irrational counterpart, magic (Leake 1952; Sauneron 1957). Further, he indicates that the rationality of medical texts in the Old Kingdom show a 56 medicine altogether (Ghalioungui 1983, 48; Grapow et al. First, authors assume that the Egyptians made a clear differentiation between the natural and supernatural, with the former belonging in the purview of science and medicine while the latter is strictly magical (David 2004). As Lang (2013, 127) points out, however, such a dichotomy did not exist: the supernatural cannot exist without its exclusion from some prior definition of the natural, but there is no equivalent distinction in Egyptian thought. Whatever else disease demons may be, in Egyptian texts they have the same existence status as the rest of the Egyptian cosmos they are in this sense perfectly natural objects. Edwin Smith, a head wound with a comminuted fracture, the treatment fluidly transitions from prescribing a medical bandage wrapped around a poultice for the wound to a magical incantation to cleanse the blood effectively and protect it from getting infected (Breasted 1930, 219–224). At the same time, Leake acknowledges the existence of similar belief structures in modern England. Furthermore, these placebos can be significantly effective even when the recipient realizes they are receiving a placebo (Kaptchuk et al. The kind of ritual involved in medicine further affects the equation; in one study, personal care and attention during treatments with a placebo pill generated 18% more pain relief than the pill alone, and 34% more relief than no treatment (Kaptchuk et al. What this essentially suggests is that these treatments traditionally deemed magical— which often involve personal attention and care—can offer significant health benefits of their own and cannot be so easily separated from “medical care. Leake even suggested that Egyptian medicine must have devolved from its rational approach in the Old Kingdom to an irrational one in the New Kingdom because of an increase in the number of spells in medical texts (Leake 1952, 77). When divine sources are involved, treatments directly affecting the divine are necessary. Conversely, when the source of the illness is traumatic, surgical treatments are necessary.
If thethoracic treatment site cannot be accessed with the delivery catheter treatment 6th feb cardiff discount duricef 250 mg without prescription, it isconsidered atechnical failure medicine 74 order duricef with paypal. Two other subjectshadmisaligned deployment medicine zetia cheap duricef 250 mg on line, and one subject had an aortic rupture treatment xeroderma pigmentosum generic duricef 500mg on-line. The objective of this ongoing registry is to gather pertinent post approval clinical data to assess the Valiant thoracic stent graft with the Captivia delivery system (“Valiant Captivia”) in the treatment of diseases of the descending thoracic aorta in both surgical and non surgical candidates. Subjects diagnosed with a variety of thoracic aortic diseases were considered candidates for the registry. Subjects who enrolled in the study will be followed for up to 3 years post implantation. A 30 day interim analysis was conducted on 50 subjects to assess acute performance of the Captivia delivery system. Three of the subjects who are included in the “Other” category also had a concurrent thoracic aortic aneurysm or Type B aortic dissection, and are therefore included in more than 1 category. Since the acute deliverability of the delivery system is less dependent upon the type of aortic etiology, subjects with dissection and other etiologies were also considered relevant to the assessment. Three subjects died and 1 subject was converted to open surgical repair within 30 days. Thirty four of the 45 eligible subjects had a follow up visit at 30 days post implant. All of the remaining 11 eligible subjects were alive and underwent clinical evaluations at subsequent follow up visits. Successful delivery and deployment was defined as deployment of the Valiant thoracic stent graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery or brachiocephalic artery, and with the removal of the delivery system. Secondary Study Endpoints Secondary study endpoints evaluated in the 30 day analysis included both procedural complications and clinical outcomes. This subject, who had risk factors for neurologic complications, also experienced paraplegia that resolved 2 days later after placement of a lumbar drain. A third death occurred in a subject with a history of Marfan’s syndrome and previous thoracic aortic dissection. The death was adjudicated as being related to the lesion in an acute complicated type B dissection. One subject required a conversion to open surgery following aneurysm rupture at the index procedure. The subject became unstable after the first stent graft was successfully delivered and deployed. The subject underwent a thoracotomy and a second stent graft was placed, successfully sealing off the rupture site. Two subjects, including the subject with Marfan’s syndrome noted above, experienced aortic dissection within 30 days of the index procedure. Disease etiologies included fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta. A 30 day analysis was conducted on 10 subjects to assess the acute performance of the Captivia delivery system. The data collected from this evaluation was considered relevant because the delivery systems for use with Talent and Valiant stent grafts are essentially identical in design and possess the same principles of operations. Study Population and Subject Accountability these 10 subjects with descending aortic aneurysms were enrolled at 4 sites in the United States to participate in the Talent Captivia Study. Of the 10 enrolled subjects, 1 subject died and another failed to receive a stent graft. Successful Delivery and Deployment Delivery and deployment of the Talent thoracic stent graft with the Captivia delivery system was assessed. Successful delivery and deployment was defined as attaining vessel access to insert the delivery catheter and deployment of the graft to the intended treatment site. One enrolled subject did not receive a Talent thoracic stent graft, as the Captivia delivery system could not reach the targeted lesion due to severe angulation of the thoracic aortic arch. One subject died within 30 days of the index procedure and was considered an aneurysm related death. Both subjects who experienced paraplegia had significant risk factors for spinal cord ischemia. Caution: Vessel damage such as dissection, perforation, or rupture may be caused by excessive oversizing of the stent graft in relation to the diameter of the blood vessel. Oversizing of the stent graft to the vessel more than the recommended device sizing as shown in Recommended Device Sizing (Section 10. Also, due to the nature of the design and the flexibility of the Valiant thoracic stent graft with the Captivia delivery system, the overall length of each stent graft component may be shorter when deployed. If preoperative case planning measurements are not certain, an inventory of system lengths and diameters necessary to complete the procedure should be available to the physician. This approach allows for greater intraoperative flexibility to achieve optimal procedural outcomes. Use of the device outside the recommended anatomical sizing may result in serious device related events. Physicians may consult with a Medtronic representative to determine proper stent graft component dimensions based on the physician’s assessment of the patient’s anatomical measurements. However, the final treatment decision is at the discretion of the physician and patient. The benefits and risks previously described should be carefully considered for each patient before using the Valiant thoracic stent graft with the Captivia delivery system. Patient Counseling Information the physician should review the following information when counseling the patient about this endovascular device and procedure: • Differences between endovascular repair and open surgical repair • Risks related to open surgical repair • Risks related to endovascular repair • Pros and cons of open surgical repair and endovascular repair • Endovascular repair is an option with potential advantages related to its minimally invasive approach • It is possible that subsequent endovascular or open surgical repair of the lesion may be required • the long term effectiveness of endovascular repair has not been established 55 • Regular follow up, including imaging of the device, should be performed at least every 6 to 12 months, or more frequently in subjects with enhanced surveillance needs. Medtronic recommends that the physician disclose to the patient, in written form, all risks associated with treatment using the Valiant thoracic stent graft with the Captivia delivery system. The list of potential risks occurring during and after implantation of the device are provided in Adverse Events (Section 5). Additional counseling information can be found in the Patient Information Booklet. Sterility Each Valiant thoracic stent graft is individually contained within a Captivia delivery system. The Captivia delivery system is sterilized using electron beam sterilization and is supplied sterile for single use only. Contents • One Valiant thoracic stent graft with the Captivia delivery system • One Device Registration Packet 9. Caution: the Valiant thoracic stent graft with the Captivia delivery system should only be used by physicians and medical personnel trained in vascular interventional techniques and in the use of this device. The following are the knowledge and skill requirements for physicians using the Valiant thoracic stent graft with the Captivia delivery system: • natural history of thoracic lesions and comorbidities associated with repair • radiographic, fluoroscopic, and angiographic image interpretation • angioplasty • appropriate use of anticoagulants (ie heparin) • appropriate use of radiographic contrast material • embolization • endovascular stent graft placement • femoral cutdown, arteriotomy, and repair • live fluoroscopic and angiographic image interpretation • nonselective and selective guidewire and catheter techniques • snare techniques • techniques to minimize radiation exposure • device selection and sizing 10. Recommended Device Sizing Medtronic recommends that the Valiant thoracic stent graft with the Captivia delivery system be used according to the sizing guidelines in Table 3 through Table 8. Use of the device outside the recommended anatomical sizing may result in serious device related adverse events or clinical incident. The specific stent graft diameter used for treatment should be oversized relative to the nondiseased vessel using the sizing guidelines to ensure appropriate radial fixation. Strict adherence to the sizing guidelines is expected when selecting the appropriate device size. Sizing outside of this range can result in endoleak, fracture, migration, infolding, or graft wear. Caution: Oversizing of the stent graft to the vessel by more than 10% may be unsafe in the presence of dissecting tissue or intramural hematoma. Caution: Proper sizing of the Valiant thoracic stent graft is the responsibility of the physician. This stent graft sizing incorporates the recommended device oversizing for anatomical dimension and was based on in vitro test data. If it is supported by the vessel, oversizing to the supporting native vessel should be used, as described in Table 3 to Table 6. In order to provide the appropriate oversizing at a component junction that is not supported by the vessel and at the distal landing zones, Closed Web Tapered configurations may need to be used.