Edmunds-WJ; Medley-GF; Nokes- DJ. European Consensus Group on Hepatitis В Immunity. in haemodialysis: Europen multicentre study Nephrol Dial Transplant 2004, 19,p. 900 -909. Oliver L.M.C.Mat, F Mesters, R Beauwens et al (Baudor, Belgium) Primary high-dose WHO, Geneva, 1993; unpublished document.
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Remote Ischemic Conditioning for the Reduction of Ischemia- Reperfusion Injury in Acute Myocardial Infarction. Summary. The auto. RIC Device is a non- invasive device that provides automated delivery of remote ischemic conditioning (RIC), a temporary stop and restart of blood flow through a series of inflations and deflations of a blood pressure arm cuff. RIC is a novel adjunctive therapy for protection against ischemia- reperfusion injury in patients presenting with ST- segment elevation myocardial infarction (STEMI). Five randomized controlled trials (RCTs) involving 9.
STEMI patients receiving RIC as an adjunctive therapy to percutaneous coronary intervention (PCI). A substantial proportion of the original cohort was excluded from the final analysis in four of the trials, which may have introduced selection bias. A four- year extension study of 2. RIC may have persistent effects on clinical outcomes, but the study lacked adequate statistical power to detect differences in clinical end points. No safety issues or complications associated with RIC were observed in any of the trials. Two large, multi- centre RCTs are in progress to determine whether using the auto.
RIC Device as an adjunctive therapy to PCI can reduce the rates of cardiovascular death and hospitalization for heart failure at one year in STEMI patients. The first is a pan- European trial that will treat patients with RIC during ambulance transport to hospital. The second trial, based in the United Kingdom, will treat patients with RIC after presentation to the emergency room. The two trials will enroll an estimated 4,0. The effects of RIC on clinical outcomes such as hospitalization, heart failure, and mortality in various patient subpopulations will need to be determined before translation into current clinical practice for STEMI.
Pending confirmatory evidence to support routine use, health care practitioners interested in piloting RIC as an adjunctive treatment for STEMI patients will need to ensure that the RIC protocol does not delay the initiation of PCI, and consider possible adverse effects such as bruising and hematomas in thrombolytically treated patients. Background. A myocardial infarction occurs when a thrombus forms in a coronary artery, resulting in a sudden disruption in blood flow to the heart muscle (ischemia) and the death of heart tissue.
Prompt restoration of blood flow (reperfusion) is the most effective strategy for reducing myocardial infarct size (the extent of heart tissue death), heart failure, ventricular arrhythmias, and mortality following a myocardial infarction. However, when blood flow to cardiac cells is disrupted and then restored, this precipitates further heart damage known as ischemia- reperfusion injury.
Despite considerable improvements in prophylaxis therapies and reperfusion strategies,3- 5 myocardial infarctions are a leading cause of morbidity and mortality in Canada. Many adjuvant treatments to limit or prevent ischemia- reperfusion injury including pharmacological agents (e. An alternative therapeutic approach to prevent ischemia- reperfusion injury is to harness innate mechanisms that condition the heart to protect itself against injury. One strategy is to apply brief episodes of ischemia followed by reperfusion to the infarct- related coronary artery using an angioplasty balloon, known as local ischemic post- conditioning. However, the protective effect of local ischemic post- conditioning has not been shown to be consistent in myocardial infarction patients, and there are potential safety concerns including additional myocardial injury, deterioration of organ function, and possible thrombus microembolization. Remote ischemic conditioning (RIC) is a novel, non- invasive technique that uses brief cycles of inflation and deflation of a blood pressure cuff on a limb distant from the heart. The mechanism through which RIC protects the myocardium from ischemic- reperfusion injury is unclear, although it has been suggested that a neurohormonal pathway conveys a cardioprotective signal to the heart from the remotely conditioned limb.
The stimulus can be applied before (pre- conditioning), during (per- conditioning), or immediately after (post- conditioning) the ischemic event. Since a myocardial infarction is an unpredictable event, pre- conditioning can only be used during elective interventions associated with myocardial ischemia- reperfusion injury such as non- emergent coronary artery bypass grafting (CABG) or percutaneous coronary interventions (PCI).
Implementing RIC as an adjunct to standard- of- care in acute care settings may improve patient outcomes following myocardial infarction. The Technology. The auto. RIC Device (Cell. Aegis Devices, Inc., Toronto, Ontario) is a non- invasive, portable device that provides automated delivery of RIC as an alternative to manually operating a standard blood pressure cuff. The auto. RIC Device System consists of a reusable controller, battery- charging cradle, and a single- use, patient- specific cuff.
Placed on the arm, the device allows for the consistent delivery of RIC as five- minute inflation and deflation cycles for a total of 4. The process is compatible with current standard- of- care treatments and can be applied in the ambulance, in a hospital, or at home, as directed by a health care professional. The automated device is expected to be easier to use and more reliable than using a standard manual blood pressure cuff,2. Regulatory Status. Health Canada granted a Class III licence to Cell. Aegis for the auto.
RIC Device in February 2. This is the first device on the market to provide automated RIC. It is approved for adults over the age of 1. The auto. RIC Device received CE Mark certification in July 2.
Europe but is not available for sale in the United States. Patient Group. The Heart and Stroke Foundation estimates that 7. Canada. 2. 3 In 2. Canada, with an average cost of $8,9. The number of hospitalizations is expected to increase as Canada's population ages. The additional cost for the projected increase in hospitalizations to 2.
In 2. 00. 9, 1. 5,1. Canada due to myocardial infarctions. Current Practice. Treatment for acute myocardial infarction focuses on restoring blood flow to the heart by removing blockages in the coronary artery within 1.
This is achieved through emergent PCI or thrombolysis with clot- dissolving drugs. PCI is a non- surgical procedure performed in a cardiac catheterization laboratory. An angioplasty balloon is used to open up the blocked coronary artery and a stent is placed to keep the artery open. Current guidelines recommend PCI as first- line therapy for acute myocardial infarction when a catheterization laboratory is available within 9. PCI- capable hospital or within 1. PCI- capable hospital. Thrombolysis is typically initiated within 3.
PCI cannot be performed within the specific time parameters or there are vascular access difficulties. CABG is a surgical procedure for bypassing blockages in the coronary artery but is less commonly performed because it is more invasive than PCI, with a longer recovery time. CABG is typically performed in patients with left main coronary artery disease, diabetics with multi- vessel disease, or patients who are not amenable to PCI. Almost 3. 0% of Canadians aged 4. PCI facility within the 9. First Nations patients in particular are less likely to undergo PCI and have a higher mortality rate from acute myocardial infarction than non- Aboriginal Canadians. The optimization of pre- hospital strategies that reduce the transfer time between the ambulance and a PCI centre can improve clinical outcomes and reduce mortality.
However, these pre- hospital strategies are currently underused in Canada. Methods. A peer- reviewed literature search was conducted using the following bibliographic databases: MEDLINE, Pub. Med, Embase, and The Cochrane Library (2. Issue 8). Grey literature was identified by searching relevant sections of the Grey Matters checklist (http: //www.
No methodological filters were applied. The search was limited to English language documents published between January 1, 2. September 1. 2, 2. Regular alerts were established to update the search until December 2. Peer- reviewed published studies evaluating the clinical efficacy and safety of RIC prior to reperfusion in acute myocardial infarction were considered for inclusion in the evidence section of this bulletin.
Unpublished data obtained from conference presentations for the selected published studies were also included. All other unpublished data, case reports, editorials, letters, and literature reviews were excluded.
The Evidence. Clinical data to support the use of RIC for the reduction of ischemia- reperfusion injury after acute myocardial infarction have been reported in five randomized controlled trials (RCTs). See Table 1.)3. 1- 3. All of the trials assessed efficacy using surrogate biomarkers of myocardial reperfusion injury, microvascular reperfusion, left ventricular function, and acute kidney injury as primary study end points in patients with ST- segment elevation myocardial infarction (STEMI). As the RIC protocol had to be initiated before reperfusion, randomization had to occur prior to PCI and before a definitive decision could be made as to whether the patient had met specific inclusion criteria. In addition, many of the enrolled patients did complete follow- up with the imaging data required to assess the primary end point.
Therefore, between 3. An extension of one of these trials. However, it was not adequately powered to detect differences in clinical end points. Four of the trials used a standard manual, upper arm blood pressure cuff, and stopwatch for the delivery of RIC prior to reperfusion with PCI. One trial used a blood pressure device (FB- 2. Fakuda Denshi, Tokyo, Japan) that was modified to perform three cycles of inflation and deflation automatically.
See Table 1.)Bøtker et al.