2007年12月12日星期三

身残志坚的王文珞写的诗,请您指正!

王文珞在学写诗,渴望得到大家的指点和对写诗心得的交流,如您有兴趣指点她或与她一起探讨,请联系她的小灵通:0813-8501419

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2007年11月30日星期五

Health Policy Of Last Resort - Blame The Doctors, Australia

Health Policy Of Last Resort - Blame The Doctors, AustraliaAMA President, Dr Rosanna Capolingua, said she was shocked by Health Minister Tony Abbott's extraordinary attack on doctors over three matters for which he has had the total cooperation of the AMA and the medical profession.Dr Capolingua said the Minister's unprovoked criticism of doctors' performance in informed financial consent (IFC), the Medicare safety net, and medical advertising appears to be a case of political point scoring by blaming doctors for policy failure on the eve of an election."The Minister's speech last night was a classic case of using a sledgehammer to crack a walnut," Dr Capolingua said."We are in agreement and working with him in all three areas, the only point of difference being the Minister's unreasonable expectation that the IFC rate should be 100 per cent of private hospital procedures."It would appear that the Minister is setting the scene for the Government to legislate to compel doctors to provide (IFC) to all patients in every situation, even when it is impossible for them to position to do so."Doctors are not in a position to discuss fees with patients who are unconscious, in pain, or in distress in accident or emergency, or when complications occur during surgery."The doctors are busy saving lives."Well over 85 per cent (and rising) of patients receive full IFC for their private hospital procedures."The small number of cases where IFC is not provided have been addressed by a joint AMA/Government education campaign over the last twelve months, and which the Government has funded for another year."You would think the Minister would be applauding the improved IFC rates, not recklessly exploiting an already identified area of non-compliance."To threaten compulsion through legislation at this stage smacks of pre-election populist politics with the old 'greedy doctors' line about gap payments."I remind the Minister that doctors charge fees. Gap payments are the domain of the private health funds and the Government."

2007年11月29日星期四

FIP Honours Outstanding Pharmacists And Pharmaceutical Scientists

FIP Honours Outstanding Pharmacists And Pharmaceutical ScientistsDuring the Opening Ceremony of the 67th FIP Congress in Beijing, China, the Federation honoured some of the world's leading pharmacists and pharmaceutical scientists with the 2007 FIP Awards. This year, the Board of Pharmaceutical Sciences awarded FIP's highest scientific honour, the Høst-Madsen Medal, to Dr Patrick Couvreur (France). The medal is given every two years to an outstanding pharmaceutical scientist, and is offered by the Danish Pharmaceutical Association to honour the memory of former FIP President Dr Høst-Madsen. Complementing this prestigious accolade within the pharmaceutical sciences were two awards recognizing outstanding achievement in Pharmacy Practice. The Distinguished Practice Award went to Ms Jane Nicholson (UK), for her longstanding contribution to and enthusiasm for many branches of pharmacy practice both in and outside of the United Kingdom. Joining her was Prof. Dr Zoltán Vincze (Hungary), the recipient of the Lifetime Achievement Award for Pharmaceutical Practice for his dedication to the advancement and improvement of Pharmaceutical Practice and recognition of pharmacists in Hungary and on a global level. In addition, the following individuals were acknowledged and will hereby by recognized as FIP Fellows, for consistently upholding the qualities and professional characteristics deemed by FIP to deserve this special recognition.

2007年11月28日星期三

Apple Q4 profits boosted by iPhone and Mac sales

Apple Q4 profits boosted by iPhone and Mac sales Apple Inc. on Monday reported strong earnings for its fourth quarter, boosted by record Macintosh computer sales and the shipment of 1.12 million iPhones.The company beat analyst estimates with net income of US$904 million, or $1.01 per share, compared with $542 million, or $0.62 per share, in net income reported in last year's fourth quarter. Analysts polled by Thomson Financial estimated a consensus of $760.45 million in net income and earnings of $0.84 per share for the quarter ended Sept. 29. The company reported $6.22 billion in revenue, up from $4.84 billion in the fourth quarter last year. The revenue consensus from analysts polled by Thomson was for $6.07 billion.For fiscal 2007, Apple reported net revenue of $24 billion and net income of $3.5 billion, said Peter Oppenheimer [CQ], Apple's chief financial officer, in a conference call with financial analysts. Looking ahead, the company estimates that revenue will hit $9.2 billion, with earnings per share of $1.42 for the first fiscal quarter of 2008, Oppenheimer said.The company shipped 2.16 million Macs during the quarter, a 34 percent growth over the year-ago period, Apple said in a news release. Mac sales increased worldwide, spurred by back-to-school promotions, said Tim Cook, Apple's chief operating officer, on the call. In addition to rapid growth in the U.S. and Europe, Mac unit shipments also increased in Japan, a major market where Apple has traditionally struggled to grow, Cook said. Shipment of Mac notebooks, including MacBook and MacBook Pro, grew 31 percent year-over-year and accounted for 62 percent of all Macs sold, Oppenheimer said.Given the success of this back-to-school period, Mac sales could be flat in the upcoming quarter, Cook warned.Sales of the iPhone are outpacing those of the iPod during the first few months after its 2001 introduction, Cook said. The company shipped 1.39 million iPhones during the year, and saw a spike in sales after a $200 price drop of the 8G-byte iPhone from $599 to $399 in September.Apple is confident it will sell 10 million iPhones in the next calendar year, Cook said.Apple sold 10.2 million iPods during the quarter, a 17 percent year-over-year growth. iPod has sold 120 million units to date, Oppenheimer said. The upcoming holiday shopping season will be a big quarter for iPod sales, Oppenheimer said.Apple had a busy quarter with multiple product announcements.Last month, it unveiled the iPod Touch, a portable multimedia player with a touchscreen user interface and Wi-Fi capabilities. It also announced availability of the iPhone in Europe, with U.K. network operator O2 (UK) Ltd. slated to start shipping the device in November. The company is excited about entering the Europe market, and plans to enter the Asia-Pacific market in 2008, Cook said. On the software front, Apple announced iWork '08, its office applications suite, in August. Mac OS X Leopard, Apple's latest operating system, will begin shipping later this week.

2007年11月27日星期二

Plague Suspected In Death Of Man In Arizona

Eric York, a 37 year old wildlife biologist who worked at the Grand Canyon National Park who was found dead at his home on the South Rim of the Canyon in Arizona on November 2nd, probably died of the plague caught while carrying out an autopsy on a mountain lion that had probably died of the disease a week earlier.Plague, due to the bacterium Yersinia pestis, was confirmed as the likely cause of death following preliminary laboratory tests at the Arizona Department of Health Services (ADHS) and the Centers for Disease Control and Prevention (CDC).York had been treated at a local clinic for flu like symptoms that started three days after he did the autopsy, but nothing more serious than that was diagnosed at the time. When he was found dead health officials suspected either plague or hantavirus that causes a type of hemorrhagic fever, and immediately tracked down 49 people who had been in recent contact with him so they could have aggressive antibiotic treatment. None of them has become ill.Plague is primarily a disease of animals and rarely infects humans, who can catch it from being bitten by rodent fleas or, as is suspected in the case of York, from direct contact with infected animals. York' symptoms were similar to those of pneumonic plague, the most serious, but least common form of plague.Plague can be passed on from one human to another, and from animals to humans, through coughing and sneezing, which thrusts infected droplets into the air that is then breathed in by others. However, according to the CDC, human to human infection is rare, and their records show the last time this happened in the US was in 1924.Symptoms of pneumonic plague include: high fever, chills, nausea, chest pain, cough, headache, and blood in the saliva. Symptoms are often accompanied by a painful, enlarged lymph node in the groin or armpit. If treated early with antibiotics, the chances of survival are very high.Anyone who has these symptoms, particularly if they have been exposed to fleas, sick cats, rodents or rabbits in areas where plague may be active, should seek medical attention immediately. Plague is considered endemic high in the mountains of northern Arizona (above 4,500 feet). 48 cases of plague have been reported in the state since 1977, eight of which were fatal. Not one was reported between 2001 and 2007, which officials put down to drought conditions and high summer temperatures.In September 2007, Arizona health officials released news of the state's first human infection since 2000, a woman in Apache County, who became ill following a flea bite at her home in the northern part of the state. She was given antibiotics and is now recovering, they said.Craig Levy, head of Arizona's Vector Borne and Zoonotic Disease Program, said at the time that:"The recent appearance of plague activity in two northern counties has us concerned that we may see plague in other areas as well." Animal cases of plague in Arizona in 2007 include prairie dog colony die-offs in two separate neighbourhoods in Flagstaff in Coconino County, and a pet cat in Prescott in Yavapai County.Arizona state health officials warned campers, hunters, hikers and others who live at 4,500 feet or higher or are visiting the area, to take the following precautions to avoid being exposed to the plague: Do not handle sick or dead animals.Don't go near rodent burrows. Avoid exposure to fleas. Stop your dog or cat from roaming as they can bring home plague infected fleas. Use flea control products on your dog or cat, ask your veterinarian about the best ones. Wear protective gloves when cleaining or skinning wild animals, for instance for cooking. If cooking game meat, do so at 180 degrees, until the juices run clear. If you get start getting symptoms like those listed above, within 6 days of a potential exposure, seek medical help at once. If your cat falls ill, get it checked by a veterinarian. For more information call the Grand Canyon National Park Incident Information Center at (928) 638-7922 or (928) 638-7688.

2007年11月26日星期一

New ESC ESH Guidelines On Arterial Hypertension

In 2000, 26% (972million) of the adult population worldwide had hypertension and this figure is estimated to rise by 2025 to 1.56billion. Such individuals have an increased risk of stroke or heart disease and the detection and effective management of such patients presents an enormous challenge to healthcare systems. Identifying specific patients at risk of developing organ damage will allow better deployment of preventative healthcare resources.Against this background, the European Society of Cardiology and the European Society of Hypertension have revised their 2003 guidelines based upon the publication of new evidence. The cornerstone of treatment remains the introduction of lifestyle measures such as increasing exercise, reducing body weight and other environmental factors such as reducing the intake of alcohol and salt before embarking on a treatment programme involving drugs.Three issues then follow: First, identifying the high-risk patient. The new guidelines continue to stratify patients according to level of presenting blood pressure and the detection of other risk factors -- metabolic syndrome, sub-clinical organ damage or diabetes or finally, established cardiovascular or renal disease. The two latter categories place patients at moderate to very high risk and of course, treatment should be very aggressive.The second issue is the class of drugs to be used. The ESC and ESH agree that the most important factor in reducing an individual's cardiovascular risk is lowering blood pressure. Against this background, there is some evidence emerging that particular classes of drugs may have the ability to protect against specific organ damage. Although this is intriguing further investigation is needed to verify the evidence. Newer classes of drug, for example, may be able to prevent the development of Type 2 diabetes or at least delay the onset of this problem, which inevitably rapidly increases an individual's cardiovascular risk.Another interesting area is the detection of sub-clinical organ damage. Initially this was largely confined to the detection of albuminuria or elevated creatinine, which is not only important parameters for defining renal function and progressive renal failure, but also for delineating increased cardiovascular risk. However, as methodology has improved the measurement of intimal medial thickness and pulse wave velocity have become more generally acceptable and with these the possibility of again defining cardiovascular risk at an earlier time-point and with more accuracy. Similarly, microcalcification of medium sized blood vessels using high resolution CT scanning has been demonstrated to be important although of course the technology necessary to measure this is much more limited. However, the concept of earlier detection of vascular damage and the recognition that it is extremely prognostically important means that we have new ways of characterising the risk associated with patients and a fresh impetus to interfere with blood pressure levels at a much earlier point to prevent irreversible end-organ damage.The third issue is the target level to be achieved. This has largely remained unchanged from 2003 with the target for the majority of patients being 140/90mmHg or less. In patients at higher risk with Type 2 diabetes and hypertension, this level is 130/80, which is now extended to patients with previous history of stroke or evidence of renal dysfunction. The importance of detecting and treating hypertension cannot be overestimated -- effective treatment of hypertension reduces the risk of developing stroke by more than 40% with almost immediate impact and on coronary artery disease, over a period of several years the risk will be reduced by more than 20%. This increasing healthcare problem needs to be tackled promptly and efficiently in an ever enlarging cohort of asymptomatic patients.

2007年11月25日星期日

Effect Of Miglustat On Bone Disease In Adult Type 1 Gaucher Disease (GD1): Results Of Apooleda Pooled Analysis

Effect Of Miglustat On Bone Disease In Adult Type 1 Gaucher Disease (GD1): Results Of Apooleda Pooled AnalysisActelion Ltd (SWX: ATLN) announced the publication of "Effect of miglustat on bone disease in adult type 1 Gaucher disease: a pooled analysis of three multinational open label studies" (Pastores et Al) in Clinical Therapeutics, vol 29, number 8, 2007. This pooled analysis investigates the efficacy of Zavesca® (miglustat) in controlling bone manifestations, such as bone pain, osteopenia and osteoporosis, bone crisis and fractures, in Gaucher Disease type 1 patients. The data in this analysis is drawn from the Zavesca pivotal studies OGT 918 - 001, 004, 005. Bone manifestations are considered among the most painful and debilitating components of Gaucher Disease type 1 highly impacting on patients' quality of life. It has been estimated that bone pain occurs in more than half of GD1 patients and that 26% will develop bone crisis (1); in addition GD1 has been shown to effect affect bone metabolism leading to an increase in bone resorption, which causes a decrease in bone mineral density (BMD), osteopenia and osteoporosis in the majority of the GD patients. Furthermore, the current standard treatment, enzyme replacement therapy (ERT), has shown only limited efficacy in GD1 related bone disease (2) (3) (4). The analysis involved 72 patients, including 41 (57%) who had received previous ERT and 20 (28%) who had undergone splenectomy. Patients' mean (SD) age was 41.2 (13.1) years. The most frequent bone related manifestations at study entry were osteoporosis (43/63 [68%] patients) and bone pain (41/65 [63%] patients). This paper, led by Dr. Gregory Pastores, associate professor of neurology and pediatrics at the New York University School of Medicine, has shown that at two years 83% (54/65) of the patients reported no bone pain compared to baseline data. The reductions in bone pain were comparable among all subgroups, including high-risk patients (i.e. splenectomized). Moreover, there were no new cases of "bone crisis", osteonecrosis or fracture; BMD Z-scores were improved from baseline at both the lumbar spine and femoral neck at each time point (months 6, 12, and 24) (P < 0.001). As early as 6 months after the initiation of miglustat monotherapy, significant increases from baseline in the BMD Z-score were observed at both the lumbar spine (mean, 0.15; P = 0.022) and femoral neck (0.23; P < 0.001); the increases remained significant at 12 months (0.19 [P = 0.012] and 0.21 [P = 0.017], respectively) and 24 months (0.21 [P = 0.015] and 0.18 [P = 0.039]). Significant increases in BMD Z-scores were observed at the femoral neck in splenectomized patients (P < 0.001) and at both sites in osteoporotic patients (lumbar spine: P < 0.001; femoral neck: P = 0.006). Lead investigator Dr Gregory Pastores commented: "Bone disease in patients with Gaucher Disease can be a source of severe debilitation and remains a major management issue. The beneficial effect of miglustat on bone manifestations and especially on bone pain in these patients might be explained by its wide tissue distribution even in deep organs such as bone and by a direct effect on bone cells." Zavesca is currently not approved for the treatment of bone manifestations in Gaucher disease type 1. About Gaucher's diseaseGaucher's disease is a rare genetic disorder, which results from reduced activity of glucocerebrosidase, a key enzyme responsible for the metabolism of glycosphingolipids (GSL - a subclass of fats). Symptoms include enlargement of spleen and liver, bone disease, anaemia, intense fatigue, and in some cases lung involvement. About Zavesca® in type 1 Gaucher DiseaseZavesca® (Miglustat) is the only oral treatment option approved for adults with type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option. It is the first in a class of drugs known as substrate reduction therapy. Zavesca® reduces the rate of formation of glucosylceramide, a glycosphingolipid that accumulates in Gaucher disease, to a level that can be cleared by the remaining enzyme, thus preventing the build up of excess glucosylceramide in the macrophage cells. Zavesca® is approved and available in the European Union, United States, Canada, Switzerland, Brazil, Australia and Israel. Zavesca is currently not approved for the treatment of bone manifestations in Gaucher disease type 1. Zavesca® safety informationMild-to-moderate tremor was reported in approximately 30% of patients in all Zavesca trials combined. Many cases were resolved spontaneously within 1 to 3 months; dose reduction may ameliorate tremor within days;3 patients claimed tremor as one of the reasons for withdrawal from the clinical trials although 1 of these was considered unrelated to Zavesca. The most common adverse reactions in all Zavesca trials combined were diarrhoea and weight loss. Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients treated with Zavesca®, either at the outset of treatment or intermittently during treatment. The majority of cases are mild and are expected to resolve spontaneously on therapy. In clinical practice, diarrhoea has been observed to respond to diet modification (reduction of lactose and other carbohydrate intake), to taking Zavesca® away from meals, and/or to anti-diarrhoeal medication such as loperamide. In some patients, temporary dose reduction may be necessary. Patients with chronic diarrhoea or other persistent gastrointestinal events that do not respond to these interventions should be investigated according to clinical practice. Zavesca® has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease. Weight loss was mild (6% - 7% of total body weight); most prevalent in the first year of treatment and stabilized thereafter; no patients claimed weight loss as a reason for withdrawal from the clinical trials.Peripheral neuropathy has been reported in type 1 Gaucher patients treated with Zavesca®. Patients should undergo a neurological exam at the start of treatment and regularly thereafter. Zavesca® should be reassessed in patients who develop symptoms of peripheral neuropathy. Zavesca® may cause fetal harm if administered to a pregnant woman and is contraindicated in women who are or who may become pregnant; patients should be apprised of the potential hazard to the foetus. There is a risk of impaired fertility in men. Men should maintain reliable contraceptive methods and not plan to conceive while taking Zavesca® and for three months thereafter. References- Mankin et al. Clin Genet 2006- Charrow et Al, 2007. - Mankin et al. Clin Genet 2006 - Pastores et al. Semin Hematol 2004Actelion Ltd Actelion Ltd is a biopharmaceutical company with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug, Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan as well as Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).

2007年11月23日星期五

GetABI Study Finds That Even Mild Atherosclerosis In The Legs Increases Mortality Substantially

GetABI Study Finds That Even Mild Atherosclerosis In The Legs Increases Mortality SubstantiallyPatients with atherosclerosis in the leg arteries face a substantially increased all cause and cardiovascular mortality risk, according to a large study presented at the European Society of Cardiology Congress in Vienna.Heart attacks and strokes as a result of atherosclerosis have been ranked for years among the most common causes of deaths in Europe. Another previously underestimated manifestation of atherosclerosis is peripheral arterial disease (PAD), which is closely associated with heart attack or a stroke.The German epidemiological study on Ankle Brachial Index (getABI) was initiated in 2001 to answer questions about whether a simple screening test on atherosclerosis can be applied to identify it at an early stage, and if so, what risk such patients carry in the future. Professor Curt Diehm from the Clinic Karlsbad-Langensteinbach, an affiliated teaching hospital of the University in Heidelberg, and his co workers from various renowned medical institutions in Germany presented a 5 year study follow-up.Professor Diehm explained: "We used the ankle brachial-index (ABI), which is simple to understand and to apply by physicians and nurses. In an individual in the supine position, the blood pressure in the leg arteries is equal to or a little higher than in the arm arteries. If atherosclerotic stenoses in the legs manifests (termed PAD), blood flow after the obstruction decreases, and the pressure in the leg artery is lower than in the arm. This sign is almost and reliable as angiography to identify your atherosclerotic risk patient."The study included a total of 6,880 unselected patients in primary care, which underwent ABI testing by their primary care physician. Mean age of the patients was 72.5 years, 58% were females, 46% were past or current smokers, 74% had hypertension, 24% diabetes mellitus and 52% lipid disorders. Of all patients, 18.0% in the total cohort had a pathological ABI test, but the majority of these patients had no clinical signs or complaints.After a 5 year observation period, all cause mortality was 24% in patients with symptomatic PAD, 19% with asymptomatic PAD (i.e., pathological ABI but no complaints), and 9% in patients without PAD. Even when all other known risk factors for cardiovascular death were accounted for by statistical means, PAD had the best ability to predict future death, stroke or myocardial infarction.Professor Diehm said, "The bad news is: we showed that in primary care every fifth patient aged 65 years or older has atherosclerosis in the leg arteries. Because atherosclerosis is not a local process but at the same time progresses in the heart and brain vessels, such patients usually die from heart attacks or stroke. The good news is that the ABI test is not limited to expert use but can be performed in general practice. Thus, family physicians can identify high risk patients and initiate and maintain effective treatment in this large group."The study also showed that the extent of the blood pressure difference between legs and arms matters: the higher the spread between both pressures is (in other words: the lower the ABI), the higher is the mortality of patients.Professsor Diehm said that every effort should be made to implement the ABI screening in standard programs for elderly patients and patients with cardiac risk factors such as diabetes or hypertension. "A huge number of lives could be saved if patients with atherosclerosis would be identified with the ABI, and treated timely."

2007年11月22日星期四

The Goals Of Platelet Inhibition In Acute Coronary Syndromes

The Goals Of Platelet Inhibition In Acute Coronary SyndromesPlatelet activation and aggregation play important roles in the pathogenesis of cardiac ischemic events after either spontaneous plaque disruption in acute coronary syndromes or mechanical disruption of coronary artery plaques caused by percutaneous coronary intervention (PCI), which could be considered an artificially induced acute coronary syndrome.Standard therapy for the prevention of thrombotic events after acute coronary syndromes and coronary stenting involves dual antiplatelet therapy with aspirin plus a thienopyridine, already established in European and American guidelines years ago. Thienopyridines, like clopidogrel and prasugrel, block platelet activation and aggregation by inhibiting the P2Y12 ADP receptor. Most clinical trials supporting the use of thienopyridines plus aspirin in PCI compared with aspirin alone were originally conducted with ticlopidine. However, clopidogrel has largely replaced ticlopidine for use in PCI because of better tolerability and a lower risk of hematologic abnormalities compared with ticlopidine.Despite the widespread use of clopidogrel in patients undergoing PCI with currently available thienopyridines, several important issues remain. Data from the Clopidogrel to Reduce Events During Observation (CREDO) trial suggest that most of the acute effect seen in reducing periprocedural events with clopidogrel was limited to patients who received the drug at least 6 hours, and perhaps as many as 15 hours, before the procedure.As irreversible inhibitors of platelet function, the effects of thienopyridines are long-lasting, and therefore seem to carry a more or less inherent risk of bleeding complications, also resulting in a reluctance in current clinical practice to give these agents before determining whether a patient is likely to need coronary bypass surgery or using it over very long periods. This balance in efficacy/side-effects may be especially important for patients that receive a drug-eluting stent, which may require prolonged powerful antiplateletherapy to avoid the recently reported very late (>1 year after drug eluting stent implantation) stent thrombosis, a serious an possibly life threatening conditition.Finally, a significant variability in the response to clopidogrel among healthy subjects and patients undergoing PCI or suffering from ACS has been observed, with some individuals having minimal inhibition of ADP-induced platelet aggregation.This concept of clopidogrel resistance led to the concern that some patients may not be adequately protected from the intense platelet activation and aggregation that occur after ACS with or without PCI and are therefore at increased risk for thrombotic events. Because of all of these issues, an improved antiplatelet regimen for the treatment of ACS and to support PCI still seems desirable.Promising results with Prasugrel (CS-747, LY640315) a novel thienopyridine antiplatelet agent that has been shown in preclinical studies and in the JUMBO TIMI 26 trial to be possibly more potent and to have a more rapid onset of action than clopidogrel.ConclusionsThe currently most used thienopyridine antiplatelet agent clopidogrel is an important component of the adjunctive therapy in ACS and PCI with (drug eluting) stenting. However since on one hand not all thrombotic complications are avoided and on the other hand still bleeding complications do occur, there seems to be room for improvement with new and hopefully better (thienopyridine) antiplatelet agents, especially since patients with drug eluting stents implanted may require prolonged treatment with this class of drugs.

2007年11月21日星期三

Imaging And Percutaneous Valve Therapy

Imaging And Percutaneous Valve TherapyThe scope of percutaneous cardiac therapy has expanded from percutaneous coronary and peripheral intervention to percutaneous valve intervention, first used in the mid eighties. Today mitral regurgitation represents the second most important native valve disease in Europe (30%) as shown by the Euro Heart Survey.When patients present with symptoms, or when there are objective signs of poor tolerance in patients without symptoms, surgery should be performed using as often as possible surgical mitral valve repair, as this treatment has shown safety, efficacy and good long-term results.However, real life observation, once again from the Euro Heart Survey, has shown that mitral valve repair is performed only 50% of the time. This shortfall is mostly due to a lack of expertise in performing the procedure. Finally, observations from the Euro Heart Survey also stress the fact that half of the patients, despite the presence of severe symptoms and severe mitral regurgitation, are not considered for surgery by their practising physicians. Thus, there is a need for treatment, other than surgery, for high-risk patients or those denied surgery.Percutaneous mitral valve repair was introduced only a few years ago. There are two different approaches to percutaneous mitral valve repair.The first approach is the edge to edge technique, which creates a double mitral valve orifice replicating the surgical intervention pioneered by Professor Alfieri. This technique is very demanding since it requires transseptal catheterisation and sophisticated collaboration between the echocardiographist and interventionist to catch the valve at the appropriate moment and location. Preliminary clinical results obtained in over 100 patients suggest that in expert hands the feasibility of the technique is high (80-90%) and the degree of mitral regurgitation can be reduced to mild in two-thirds of cases. In addition, the risk is low, once again, in experienced centres. In patients where the procedure was successful, two-thirds of the cases remained event free after three years. Thus these data, even if only preliminary, are encouraging.The second possible approach is mitral annuloplasty, which is achieved by introducing a constraining device in the coronary sinus located in the vicinity of the mitral annulus. The rationale here is that ring annuloplasty is almost always combined with other procedures during surgical interventions on the mitral valve. More than ten devices have been designed and three are currently being studied. They share common technical features: distal fixation and proximal fixation in the coronary sinus and a bridge between these two fixating elements. Here the procedure is easier since it only requires a catheterisation of the coronary sinus. Preliminary results from the EVOLUTION study in 60 patients show here again high feasibility (90%) and good safety profiles since almost 80% of the patients experienced no complications within 90 days. Very preliminary efficacy data suggest a reduction in the degree of regurgitation.Clearly at the present stage these two approaches do not yet reach the standard of the multiple surgical techniques that make the success of surgical mitral valve repair.The annuloplasty technique could be potentially used in patients with functional mitral regurgitation, while the edge to edge technique could be used in selected patients with degenerative mitral regurgitation.The potential clinical indications of the new percutaneous techniques are represented by the vast group of patients with contraindications or judged to be at very high risk for surgery. Before considering extending the application of these techniques to other patients, trials should be performed in order to answer 3 major questions: how much are we ready to lose in terms of efficacy by going percutaneously as opposed to surgically? Secondly, how much are we ready to risk in patients who have not yet reached surgical indication? And finally, will the performance of this percutaneous intervention compromise subsequent treatment possibilities?Many devices are currently being studied or are at the experimental stage: suture based direct annuloplasty, percutaneous mitral valve replacement, or transpericardial left ventricular remodelling.In conclusion, the first steps of percutaneous mitral valve repair have been taken in almost 300 patients and show the feasibility of this technique suggesting also a reduction in the degree of mitral regurgitation.Today, we are at the stage of evaluation and the research should be carefully evaluated in comparison with surgery and standard contemporary medical treatment including cardiac resynchronisation. Trials such as EVEREST II, EVOLUTION II, and AMADEUS are underway.The development of these new techniques will require close collaboration between engineers, interventionalists, imaging specialists, and surgeons.