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Re: MIP: Many questions unanswered.
- Vincenzo De Santis (31 May 2006)
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MIP: Many questions unanswered.
- Dr Sumit Kumar Jha, Dr Ashok Kumar BP, SHO Anaesthetics. Dublin. (18 May 2006)
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Vincenzo De Santis University of Rome
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Dear Sumit Kumar , Many thanks indeed for your interest in our paper. Over the past 30 years, hundreds of experimental interventions (both pharmacologic and nonpharmacologic) have been reported to protect the ischemic myocardium in experimental animals; however, with the exception of early reperfusion, none has been translated into clinical practice. The National Heart, Lung, and Blood Institute convened a working group to discuss the reasons for the failure to translate potential therapies for protecting the heart from ischemia and reperfusion and to recommend new approaches to accomplish this goal. The Working Group concluded that cardioprotection in the setting of acute myocardial infarction, cardiac surgery, and cardiac arrest is at a crossroads. The Working Group urged a new focus on translational research that emphasizes efficacy and clinically relevant outcomes, and recommended the establishment of a system for rigorous preclinical testing of promising cardioprotective agents with clinical trial-like approaches (ie, blinded, randomized, multicenter, and adequately powered studies using standardized methods). Our pilot study was designed to provide preliminary data to test the hypothesis that levosimendan has a preconditioning effect in patients. A power analysis performed on the basis of this study suggests a sample size requirement of 96 patients (48 in each group) would be needed to detect a reduction in median ICU length of stay from 35 h in the control group to 24 h in the protocol group (a=0.05, power 0.9). This further trial is currently underway in our hospital. Conflict of Interest:None declared |
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Dr Sumit Kumar Jha, Senior House Officer, Anaesthetics. Pinderfields General Hospital, Wakefield, Dr Ashok Kumar BP, SHO Anaesthetics. Dublin.
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Dear Editor, I read with interest the article by Dr L. Tritapepe et al on Preconditioning effects of levosimendan in coronary artery bypass grafting—a pilot study. We agree with the therapeutic implications of myocardial ischaemic preconditioning. But the question remains: Does it actually work? The concept, as we know it today, originated from an observation that mortality in Ischaemic Heart disease was noted to be less in patients who had suffered from anginal episodes in the past, rather than the other subgroup of patients who suffered MI as the first presentation to the hospital. As such, the authors have rightly pointed out the need for a larger number of patients to be recruited for the study. The pilot study demonstrates that pharmacological preconditioning with a short duration infusion of levosimendan in cardiac surgical patients before commencing CPB appears to confer additional myocardial protection beyond that provided by cardioplegia alone, as manifested by a better haemodynamic recovery and lower postoperative TnI levels. The authors have also pointed out that although, in this setting, the use of cardiac specific markers for diagnosis and quantitation of myocardial damage is still debated. As such, we believe that there a lot of ethical issues involved in new drug trials in a high-surgical risk patient population. We congratulate the authors in conducting the first study, albeit preliminary, that has investigated levosimendan-induced myocardial protection in humans with ischaemic heart disease undergoing a major cardiac and circulatory insult. Conflict of Interest:None declared |
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