Training on the use of transendocardial delivery of biologics for cardiac regeneration.

he delivery of biologics for cardiac regeneration is an emerging spect of interventional cardiology, and we were interested to read he recently published recommendations of the International ociety for Cardiovascular Translational Research (ISCTR) Task orce by Dib et al (1). The ISCTR Task Force is to be commended for their efforts in reating the published recommendations. Although we support heir pre-clinical recommendations, we do not agree with the ecommendations for clinical experience in the use of transendoardial delivery of biologics. Animal lab experience, although aluable, is not representative of the challenges involved in perorming clinical cases. In addition, we believe that the intervenionalist in training must become proficient in diagnostic mapping nder the supervision of highly experienced operators before ndertaking clinical injection procedures. Only after proficiency in apping is demonstrated should the trainee continue to performng proctored clinical cases. In addition, we believe that trainees hould successfully perform more proctored cases than recomended by the ISCTR Task Force before obtaining certification. Our recommendations for more proctored cases are based on ur extensive experience with these procedures. We have been erforming endocardial mapping for acute and chronic ischemia at he Texas Heart Institute since 1998. Our experience in using apping procedures in a cell therapy setting comprises multiple arge animal studies and clinical trials, including the first U.S. Food nd Drug Administration–approved trial in the U.S. in patients ith chronic ischemia. Furthermore, we developed criteria and a rotocol for the identification of viable myocardium and therapeuic injections with NOGA mapping. In 2000, we launched the apping Excellence Program to train physicians throughout the orld in endocardial mapping. As a training site for NOGA ndocardial mapping and injection, we have developed a successful raining program that includes a didactic overview, hands-on raining in the animal laboratory, written and video materials, esting, and certification. Upon completion of the program, phyicians are encouraged to send us their maps for review and eedback before initiating their clinical injection programs. The ISCTR’s suggested recommendations are an excellent eginning. However, we believe that the suggested training guideines are not stringent enough to ensure the safety of patients ndergoing the NOGA-guided delivery of biologics. We suggest urther dialogue and refining of the guidelines.