{"id":668232,"date":"2019-07-26T11:05:31","date_gmt":"2019-07-26T15:05:31","guid":{"rendered":"http:\/\/www.rochester.edu\/advancement\/?p=668232"},"modified":"2019-07-31T09:06:18","modified_gmt":"2019-07-31T13:06:18","slug":"ur-medicine-fda-approved-heart-surgery-technique","status":"publish","type":"post","link":"https:\/\/www.rochester.edu\/advancement\/ur-medicine-fda-approved-heart-surgery-technique\/","title":{"rendered":"UR Medicine\u2019s Effort to Bring New Heart Surgery Technique to the U.S. Pays Off: the FDA Just Approved It"},"content":{"rendered":"<p>[vc_row row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; background_image=&#8221;668332&#8243; css_animation=&#8221;&#8221; box_shadow_on_row=&#8221;no&#8221;][vc_column][vc_empty_space height=&#8221;100px&#8221; image_repeat=&#8221;no-repeat&#8221;][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; use_row_as_full_screen_section_slide=&#8221;no&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; box_shadow_on_row=&#8221;no&#8221;][vc_column_inner width=&#8221;1\/4&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1564153255315{padding-top: 15px !important;padding-right: 5px !important;padding-bottom: 15px !important;padding-left: 5px !important;}&#8221;]<\/p>\n<h1 style=\"text-align: center; white-space: no-wrap;\">UR Medicine\u2019s Effort to Bring New Heart Surgery Technique to the U.S. Pays Off: the FDA Just Approved It<\/h1>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/4&#8243;][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=&#8221;100px&#8221; image_repeat=&#8221;no-repeat&#8221;][\/vc_column][\/vc_row][vc_row row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;grid&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; box_shadow_on_row=&#8221;no&#8221;][vc_column css_animation=&#8221;fadeIn&#8221;][vc_empty_space height=&#8221;40px&#8221; image_repeat=&#8221;no-repeat&#8221;][vc_column_text]<\/p>\n<h3 style=\"text-align: center;\">First performed at Strong, it\u2019s expected to accelerate healing for patients across the nation<\/h3>\n<p>[\/vc_column_text][vc_empty_space height=&#8221;25px&#8221; image_repeat=&#8221;no-repeat&#8221;][vc_column_text]<span class=\"normal\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-full wp-image-668392\" src=\"http:\/\/www.rochester.edu\/advancement\/wp-content\/uploads\/2019\/07\/img_0554.jpg\" alt=\"\" width=\"500\" height=\"281\" srcset=\"https:\/\/www.rochester.edu\/advancement\/wp-content\/uploads\/2019\/07\/img_0554.jpg 500w, https:\/\/www.rochester.edu\/advancement\/wp-content\/uploads\/2019\/07\/img_0554-300x169.jpg 300w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" \/>Pioneering efforts by UR Medicine cardiac surgery teams led to recent FDA approval of a new technique for implanting a life-saving heart pump. The procedure is less invasive, making recovery easier for people with advanced congestive heart failure. Until the technique was\u00a0<a href=\"http:\/\/sites.mc.rochester.edu\/faculty\/updates\/180312_cardiology_lvad_minimally_invasive\">performed at Strong Memorial Hospital last year<\/a>, it had never been tried in the United States. Adoption of the technique is expected nationwide.<\/span><\/p>\n<p><span class=\"normal\">\u201cWhen you are doing pioneering work and receive approval after the FDA\u2019s rigorous review process,\u00a0<em>that\u2019s huge<\/em>,\u201d said cardiologist\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/people\/23817470-jeffrey-d-alexis\">Jeffrey Alexis, M.D.<\/a>\u00a0He is medical director of the\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/heart\/treatments\/minimally-invasive-cardiac.cfm\">UR Medicine Heart &amp; Vascular<\/a><a href=\"https:\/\/www.urmc.rochester.edu\/heart\/programs\/heart-failure\/vad.cfm\">LVAD program<\/a>, one of the largest in the country. \u201cAs leading heart centers adopt this implant technique, patients with heart failure will recover faster with improved quality of life, which is our goal every day.\u201d<\/span><\/p>\n<p><span class=\"normal\">Using this alternate approach, surgeons attach the HeartMate 3 left ventricular assist device (LVAD), pictured here, to the heart using two small incisions, avoiding the need to open the sternum, or \u201ccrack the chest.\u201d The device, made by Abbott, supplements the pumping action of a weakened heart, and studies show that using this technique allows patients to heal faster.<br \/>\n<\/span><\/p>\n<p><span class=\"normal\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-668402 alignleft\" src=\"http:\/\/www.rochester.edu\/advancement\/wp-content\/uploads\/2019\/07\/hm3_system_mr_lowres.jpg\" alt=\"\" width=\"300\" height=\"225\" \/>In 2001, Strong heart failure specialists began using LVADS,\u00a0 a vital component of <a href=\"https:\/\/www.urmc.rochester.edu\/heart\/programs\/heart-failure\/index.cfm\">advanced heart failure<\/a> care. They found the traditional implant technique, which required open heart surgery, made it difficult for some people with advanced heart failure to endure given the long and painful recovery period as the chest bone heals.<\/span><\/p>\n<p><span class=\"normal\">When Cardiac surgeon\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/people\/30811171-igor-gosev\">Igor Gosev, M.D.<\/a>, surgical director of the LVAD program, learned European physicians had successfully implanted the device without opening the sternum, he was anxious to provide it for patients in Upstate New York.<br \/>\n<\/span><\/p>\n<p><span class=\"normal\">The HeartMate 3 is smaller than previous LVADs, making it ideal for a\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/news\/story\/5293\/new-lvad-heart-pump-surgery-is-minimally-invasive-and-led-by-ur-medicine.aspx\">sternal-sparing implant approach<\/a>.\u00a0<\/span><\/p>\n<p><span class=\"normal\">Gosev and\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/people\/22977892-peter-a-knight\">Peter Knight, M.D.<\/a>, an expert in\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/heart\/treatments\/minimally-invasive-cardiac.cfm\">minimally invasive heart surgery<\/a>, gathered a team to perfect the technique and introduced it at\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/strong-memorial.aspx\">Strong Memorial<\/a> in February 2018.<br \/>\n<\/span><\/p>\n<p><span class=\"normal\">\u201cOur patients do very well with this surgery and we look forward to seeing the positive impact it will have on people with advanced heart failure as other centers around the country begin to offer it,\u201d Gosev said.<\/span><\/p>\n<p><span class=\"normal\">More than 100 people have received pumps this way and outcomes are positive. Patients have shorter hospitalizations, fewer complications and less pain, all contributing to faster recovery and return to their normal routine. Earlier this year, a man from the Buffalo area returned home just four days after the surgery. That\u2019s about a week sooner than patients who have the open surgery.<br \/>\n<\/span><\/p>\n<p><span class=\"normal\">The team published two studies that demonstrate its benefits, providing valuable evidence for the FDA to consider.<\/span><\/p>\n<p><span class=\"normal\">\u201cIn the beginning we were anxious but our patient outcomes have been positive,\u201d said Knight, the Marjorie B. Morris Endowed Professor in Cardiac Surgery. \u201cImpact of FDA approval means it\u2019s going to open up the opportunity for us to expand our national reputation for excellence in minimally invasive surgeries as we train surgeons to do sternal-sparing HeartMate 3 implant.\u201d<\/span>[\/vc_column_text][vc_column_text]<span class=\"normal\"><strong>National LVAD leaders<br \/>\n<\/strong><\/span><\/p>\n<p><span class=\"normal\">More than 5.7 million people in the U.S. suffer from heart failure and approximately 915,000 new patients are diagnosed each year. Advanced congestive heart failure treatment options are limited, but LVADs with or without\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/heart\/programs\/heart-failure\/transplant.cfm\">heart transplantation\u00a0<\/a>help to extend survival.<br \/>\n<\/span><\/p>\n<p><span class=\"normal\">\u201cWhen people are facing this disease, the opportunity to have a better quality of life is critically important.\u00a0 LVAD technology has offered a significant advance in their care,\u201d Alexis said.<br \/>\n<\/span><\/p>\n<p><span class=\"normal\">Strong Memorial is home to one of the top 10 centers for LVAD use in the country. The heart failure team participated in early clinical studies, dating back to 2001, that led to standard use of the pumps. And last year, after a large clinical trial that included many Strong Memorial patients, the HeartMate 3 was approved for long-term use.<\/span><\/p>\n<p><span class=\"normal\">\u201cOur VAD team has more than 200 years of combined experience working with these pumps. Their knowledge and expertise is essential to providing our patients the best possible outcomes,\u201d said\u00a0<a href=\"https:\/\/www.urmc.rochester.edu\/people\/30068971-sunil-m-prasad\">Sunil Prasad, M.D.<\/a>, chief of Cardiac Surgery and the Dr. Jude S. Sauer Family Distinguished Professor in Cardiac Surgery.<br \/>\n<\/span><\/p>\n<p><span class=\"normal\">Over the past 20 years, nearly 700 people from across Upstate and Western New York and Pennsylvania have received these high-tech devices at UR Medicine\u2019s Strong Memorial.<\/span>[\/vc_column_text][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; use_row_as_full_screen_section_slide=&#8221;no&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; box_shadow_on_row=&#8221;no&#8221;][vc_column_inner][vc_empty_space height=&#8221;20px&#8221; image_repeat=&#8221;no-repeat&#8221;][vc_column_text fnt_family=&#8221;Roboto Condensed&#8221; fnt_size=&#8221;12&#8243; css=&#8221;.vc_custom_1564151974418{border-top-width: 1px !important;border-top-color: #c4c4c4 !important;border-top-style: solid !important;}&#8221;]<em><span style=\"color: #999999; font-size: 15px;\">Published on July 24, 2019<\/span> <\/em><br \/>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pioneering efforts by UR Medicine cardiac surgery teams led to recent FDA approval of a new technique for implanting a life-saving heart pump. The procedure is less invasive, making recovery easier for people with advanced congestive heart failure.<\/p>\n","protected":false},"author":26,"featured_media":668392,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-668232","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>UR Medicine\u2019s Effort to Bring New Heart Surgery Technique to the U.S. Pays Off: the FDA Just Approved It - Advancement<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rochester.edu\/advancement\/ur-medicine-fda-approved-heart-surgery-technique\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UR Medicine\u2019s Effort to Bring New Heart Surgery Technique to the U.S. Pays Off: the FDA Just Approved It - Advancement\" \/>\n<meta property=\"og:description\" content=\"Pioneering efforts by UR Medicine cardiac surgery teams led to recent FDA approval of a new technique for implanting a life-saving heart pump. 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