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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThere is a need for innovations in pediatric congenital heart disease (CHD) therapy and considered the key rules that are associated with achieving this.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology genomics\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EIn presenting the Mullins Lecture, James E. Lock, MD, Boston Children\u0027s Hospital and Harvard Medical School, Boston, Massachusetts, USA, addressed the need for innovations in pediatric congenital heart disease (CHD) therapy and considered the key rules that are associated with achieving this.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EDrawing on his own clinical experiences, Dr. Lock discussed medical innovation, in pediatric CHD or any specialty, as a multistage process, defining 8 important steps required to allow breakthroughs to deliver improved clinical capabilities.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EREVIEW THE LITERATURE\u003C\/h2\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EAn initial, thorough review of the medical literature\u2014at least 50 papers\u2014is a vital step for any researcher embarking on an innovative project. Dr. Lock emphasized the need to avoid focusing excessively on the recent literature, because often the most important information can be found in the oldest publications. Because innovation commonly links unrelated topics, he stressed the significance of not limiting a literature review to directly related subject matter. For instance, when they performed their first transcatheter ventricular septal defect closure, Dr. Lock and colleagues were able to avoid using blade pulmonary valvotomy after reviewing data from a 1953 paper by Rubio-Alvarez and colleagues. The technique appeared successful in 1 case described in the paper, but there was an overall lack of evidence for improved patient outcomes using this procedure due to a lack of success in 3 additional patients.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EDEVELOP ANIMAL MODELS\u003C\/h2\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EAnimal models remain a vital component of innovation, and wherever possible, they should be used to evaluate a new procedure. Dr. Lock referred to a neonatal lamb model of branch pulmonary artery stenosis as one of the most important models with which he has been involved. It demonstrated that balloon angioplasty works in the absence of atherosclerosis by means of a controlled tear of the vessel\u0027s tunica intima and part of the media, and it formed the basis of efforts to perform a successful angioplasty.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EHowever, animal models have limitations and often fail to work as planned. They must sufficiently mimic the human disease to be relevant, so it is important to take into account key differences in anatomy and physiology between humans and the animal species under consideration. For example, thrombophilia occurs more readily in sheep than humans.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-4\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ECONSULT WITH COLLEAGUES\u003C\/h2\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EEstablishing and maintaining an extensive consultation network with colleagues is an essential aspect of innovating success. Cooperation and collaboration with experts in different medical specialties\u2014such as surgeons for hybrid procedures, electrophysiologists for ablation, and anesthesiologists for high-risk interventions\u2014are important, not only in propelling an innovative idea but also in building political consensus for it.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-5\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EMAKE A LIST\u003C\/h2\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EDr. Lock stressed the need to avoid focusing narrowly on one particular approach to the problem. Instead, he advised that innovators must formulate as long a list as possible of potential approaches to the problem and evaluate them thoroughly before choosing one. When starting to perform fetal aortic valve interventions, for instance, Dr. Lock and his team selected their preferred imaging technique, approach to fetal rotation, catheter access route, and cannula type after careful consideration of all available options.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-6\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ESELECT YOUR FIRST CASE CAREFULLY\u003C\/h2\u003E\n         \u003Cp id=\u0022p-9\u0022\u003ETo maximize the chance of procedural success, Dr. Lock also highlighted the importance of picking the first patient very carefully, stating that many people fail to consider this. Wherever possible, a new procedure should first be performed on a patient with a serious medical problem for which there are few, if any, treatment options available. The patient\u0027s family must also be strongly supportive of using the innovative procedure, which should itself be a technically straightforward one. It should also be performed with existing tools that can be subsequently modified as necessary, because any protocol will need to be refined after its first use.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-7\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EUSE PEER REVIEW FOR REGULATORY APPROVAL\u003C\/h2\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EProtocols for first-in-human procedures should be submitted for peer review to determine whether the risk\/benefit ratio favors performing a technique that has not been done before. Instead of an institutional review board\u2013 generated protocol, this should be a patient-specific\u2014not patient-generic\u2014and procedure-specific review. Uninvolved peers should be used to determine whether it is in the patient\u0027s best interest to undergo the new procedure. This type of regulatory approval is well accepted by regulatory agencies and institutional leadership.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-8\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EPERFORM A MOCK DRILL\u003C\/h2\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EIt is also essential to perform a thorough mock drill of the technique in advance of performing it in the first patient. Although it is impossible to anticipate all problems in advance, this exercise will enable you to see some of the issues that can potentially arise, and determine how you should respond to them, thereby improving the likelihood of procedural success in the patient.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-9\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EBE SURE TO SUCCEED\u003C\/h2\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EIt is imperative to have a successful first case involving a new procedure. Although failure is more bearable in end-stage patients, in whom comorbid diseases greatly reduce the chances of success, it is devastating in cases in which patients have other treatment options. Also, if the procedure fails in the first patient, it becomes increasingly difficult to obtain permission to perform the procedure in future cases, and this sets back progress in the field significantly.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EIn addition to the need to be honest and self-critical to maintain credibility and reduce the risk for making a mistake more than once, Dr. Lock stressed the importance of sharing the credit for success with all colleagues involved. Concluding that nothing succeeds like success, he also advised against publishing single case reports of first-in-human procedures, because of the steep learning curve between the first and subsequent cases.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/9\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022The editors would like to thank the many members of the 2014 Society for Cardiovascular Angiography and Interventions presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1106868765\u0022 data-figure-caption=\u0022The editors would like to thank the many members of the 2014 Society for Cardiovascular Angiography and Interventions presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure1\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/9\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/9\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure1\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/13\/9\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16425\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\n               \u003Cp id=\u0022p-14\u0022 class=\u0022first-child\u0022\u003EThe editors would like to thank the many members of the 2014 Society for Cardiovascular Angiography and Interventions presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/13\/9.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzoyre\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzoyre\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}