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P L C SYSTEMS INC Message Board

  • doc.reality doc.reality May 7, 2013 9:20 AM Flag

    "... RenalGuard has become the standard of care ..."

    Awesome news.
    see full article on the company's website : RenalGuard Clinical Data Presented at International Conference of the Israel Heart Society

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    • Competition; it's free and interventionalists will try it.
      J Am Coll Cardiol. 2013 Mar 13. pii: S0735-1097(13)01001-2. doi: 10.1016/j.jacc.2013.02.023.
      Renoprotective effect of remote ischemic postconditioning by intermittent balloon inflations in patients undergoing percutaneous coronary intervention.
      Deftereos Cardiology, Athens General Hospital, Athens.
      OBJECTIVES: The aim of the present study was to assess the efficacy of remote ischemic postconditioning (RIC) by repeated intermittent balloon inflations in preventing acute kidney injury (AKI) in patients with a non-ST elevation myocardial infarction (NSTEMI) undergoing PCI.
      BACKGROUND: AKI complicating PCI is associated with increased morbidity and mortality. Remote ischemic preconditioning, using cycles of upper limb ischemia-reperfusion as conditioning stimulus, has been recently shown to prevent AKI in patients undergoing elective coronary angiography.
      METHODS: Eligible patients were randomized to receive RIC by cycles of inflation and deflation of the stent balloon during PCI or a sham procedure (controls). The primary endpoint was AKI, defined as an increase of ≥0.5 mg/dl or ≥25% in serum creatinine within 96 hours from PCI. The 30-day rate of death or rehospitalization for any cause was one of the secondary endpoints.
      RESULTS: 225 patients were included (median age 68, 36% female). AKI rate in the RIC group was 12.4% versus 29.5% in controls (p=0.002; odds ratio 0.34, 95% confidence interval 0.16-0.71). The number needed to treat to avoid one case of AKI was 6 (95% confidence interval 3.6-15.2). The 30-day rate of death or rehospitalization for any cause was 22.3% in controls versus 12.4% in RIC patients (p=0.05).
      CONCLUSION: RIC by serial balloon inflations and deflations during PCI was found to confer protection against AKI in patients with NSTEMI undergoing PCI. The reduction in the rate of AKI was translated into a clear trend (of borderline significance) towards better 30-day clinical outcome.

      • 4 Replies to ternat9
      • Why would this be an either/or situation, like peanut butter or jelly? Flush the system to remove the contrast ASAP while using the "conditioning" to gain the additional immune response. Between the 2, this technique makes for a harder sell from an intuitive standpoint, not unlike convincing people to blast laser holes in their heart... interesting science, but on somebode else, thank you. Most people would chose something they can understand the "why it works", especially if that something is labled "the standard of care" and gets paid for by insurance.

      • Correct me if I'm wrong, but the conclusion for the procedure you posted says a clear trend of borderline significance. Borderline significance does not get hearts pounding and would hardly create a strong incentive to use it.
        As we know RG in its trials has shown strong clinical significance thus far.
        Then you also said small clinical studies have been promising. Seriously, the medical world is littered with things that looked promising in small trials but were worthless in large appropriately sized trials. That happens more often than not.
        A little early to be seriously concerned about this.

      • Not a good competitor in practice, IMO. Moderately long prep time, and arguably trading a small risk of harm unambiguously traceable to the balloon inflations (emboli) vs larger risk of harm from AKI (malpractice nightmare). What we saw with Heart Laser (and what Volcano is wrestling with in intravascular sensing) is that techniques get used a lot more often if they're compatible with existing work flow.

      • very interesting, Ternat9. What is the theory behind why intermittent ballonn inflations should effect kidney function, contrast effects, AKI?

    • I hate being a broken record, but we have known it works for a long time. The problem is turning that into a business.

      • 1 Reply to jacosa
      • Earlier this morning I wrote PLC suggesting that their PR should have had a different headline, other than the bland, non-arresting, uniformative, "New data presented..."
        Instead, the PR could have been headlined, "RG has become the standard of care; new data presented at Israeli heart conferecnce." Or even, "New data confirm RG's effectiveness: device and procedure has become standard of care in Isreal."
        Seems to me that to hide the *findings* of the data under a neutral headline like "Data presented..." is close to PR incomopetence.

    • I have to agree. That is awesome news. To be called the standard of care at that medical center is a big step.

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