Medical Devices: Evidence and Research (Dec 2014)
Transmyocardial revascularization devices: technology update
Abstract
Bogdan A Kindzelski, Yifu Zhou, Keith A Horvath Cardiothoracic Surgery Research Program, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA Abstract: Transmyocardial laser revascularization (TMR) emerged as treatment modality for patients with diffuse coronary artery disease not amendable to percutaneous or surgical revascularization. The procedure entails the creation of laser channels within ischemic myocardium in an effort to better perfuse these areas. Currently, two laser devices are approved by the US Food and Drug Administration for TMR – holmium:yttrium–aluminum–garnet and CO2. The two devices differ in regard to energy outputs, wavelengths, ability to synchronize with the heart cycle, and laser–tissue interactions. These differences have led to studies showing different efficacies between the two laser devices. Over 50,000 procedures have been performed worldwide using TMR. Improvements in angina stages, quality of life, and perfusion of the myocardium have been demonstrated with TMR. Although several mechanisms for these improvements have been suggested, evidence points to new blood vessel formation, or angiogenesis, within the treated myocardium, as the major contributory factor. TMR has been used as sole therapy and in combination with coronary artery bypass grafting. Clinical studies have demonstrated that TMR is both safe and effective in angina relief long term. The objective of this review is to present the two approved laser devices and evidence for the safety and efficacy of TMR, along with future directions with this technology. Keywords: laser, revascularization, angiogenesis, coronary artery disease