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First Imaging Agent Approved for Visualization of Myocardial Sympathetic Innervation in Specific Heart Failure Patients

By MedImaging International staff writers
Posted on 01 Apr 2013
A new imaging agent has been approved in the United States for the scintigraphic evaluation of myocardial sympathetic innervation (cardiac nerve activity) to help in the assessment of patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. The agent will help identify patients with one and two-year mortality risks as indicated by an H/M ratio >1.6.

GE Healthcare (Chalfont St. Giles, UK) reported on the US Food and Drug Administration (FDA) approval of a new indication for AdreView (iobenguane I 123 injection), the first and only US Food and Drug Administration (FDA)-approved molecular imaging agent to link nerve function in the heart to a patient’s mortality risk. In patients with congestive heart failure (CHF), utility has not been established for choosing therapy, tracking response to therapy, or to identify a patient with high risk of death.

“Predicting disease progression in heart failure patients can be difficult, and there are currently a limited number of prognostic tools available to help clinicians understand the likelihood for heart failure progression,” said James Arrighi, MD, associate professor of medicine, Brown University (Providence, RI, USA), and current president of the American Society of Nuclear Cardiology. “Now, with AdreView, we have a tool that will provide clinicians with a numeric score to help stratify mortality risk, and may help to promote more informed clinical decision-making.”

Increased myocardial sympathetic activity is a key characteristic of heart failure and is frequently associated with decline in left ventricular function, worsening heart failure symptoms, and sudden cardiac death. This increase leads to a depletion of norepinephrine (NE) storage and uptake. AdreView offers a way to evaluate the neuronal capacity for uptake and storage of NE. While current prognostic tests look at the effect of the disease on heart muscle and blood flow, imaging with AdreView utilizes the heart to mediastinum (H/M) ratio to evaluate the functionality of the sympathetic nerves.

The H/M ratio, with the agent, is a measure of radioactivity uptake in the heart compared to that of a reference region in the mediastinum. This measurement has a typical range of 1–2.4 and can effectively identify patients with lower than average one- and two- year mortality risk. In clinical studies, an AdreView Score (H/M ratio) of ≥ 1.6 was linked with a 99% likelihood of survival at one year (negative predictive value [NPV]).

“GE Healthcare is committed to providing innovative and effective medical products that will aid physicians in determining mortality risk in patients with cardiovascular disease, and we are pleased that the FDA has approved AdreView for this indication in heart failure patients,” said Terri Moench, general manager, single photon emission tomography (SPECT), GE Healthcare medical diagnostics. “The use of imaging tests is consistent with current trends towards gaining improved and earlier understanding of heart disease at a molecular level and may enable providers to help deliver better care to more people.

The safety and efficacy of AdreView were evaluated in two open-label, multicenter, international trials in 985 patients with NYHA class II or class III heart failure with LVEF < 35%. A total of 110 patients without a history of heart disease also received a single dose of AdreView. The endpoint for analysis was all-cause mortality, an outcome confirmed by review of an independent adjudication committee. By 12 months after enrollment among the 964 heart failure patients in the efficacy population, 50 (5%) patients had died, 61 (6%) had missing follow-up data, and 3 patients had missing H/M ratios. One-year mortality rates in relation to AdreView H/M ratio were < 1.2: 13.4%; 1.2-1.6: 5.5%; ≥ 1.6: 1.0%. By 23 months following enrollment (the requirement for designation of two-year follow-up), 96 (10%) patients had died, 201 (21%) patients had missing follow-up information and 3 patients were missing H/M ratio data. Two-year mortality rates in relation to AdreView H/M ratio were < 1.2: 22.0%; 1.2-1.6: 11.5%; ≥1.6: 3.3%.2.

Heart failure is a persistent, progressive disorder in which the heart muscle is cannot pump adequate blood through the heart to meet the body’s needs. Patients who have earlier suffered from heart failure have a sudden death rate that is six to nine times greater than the general population.

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87 (98.943710327148): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294745459 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
88 (62.227249145508): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294745459 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
89 (50.783157348633): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`
90 (102.99682617188): SELECT show_live FROM jos_com_show_setting LIMIT 1
91 (51.975250244141): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (51.975250244141): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (45.061111450195): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (47.922134399414): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (43.869018554688): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (66.041946411133): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (49.114227294922): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (49.114227294922): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (46.014785766602): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (49.114227294922): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (46.968460083008): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (47.922134399414): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (43.153762817383): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (138.0443572998): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
105 (93.936920166016): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
106 (107.0499420166): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294745459 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (87.976455688477): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294745459 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (149.96528625488): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
109 (86.069107055664): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
110 (83.92333984375): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294745459 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (897.16911315918): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294745459 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (913.14315795898): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
113 (535.96496582031): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
114 (189.06593322754): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
115 (102.99682617188): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
116 (107.76519775391): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
117 (47.922134399414): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
118 (84.877014160156): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
119 (69.856643676758): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
120 (62.942504882812): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
121 (53.167343139648): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
122 (501.15585327148): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294745459 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294745459 AND type='deeppockets_item' AND published='1' LIMIT 1
123 (!!!!! 874558.92562866): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
124 (114.91775512695): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
125 (77.962875366211): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800513 LIMIT 1
126 (50.067901611328): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800513 LIMIT 1
127 (94.890594482422): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800359 LIMIT 1
128 (52.928924560547): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800359 LIMIT 1
129 (56.028366088867): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800361 LIMIT 1
130 (48.160552978516): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800361 LIMIT 1
131 (736.95182800293): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
132 (615.11993408203): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
133 (89.883804321289): SELECT name FROM jos_deeppockets WHERE id=213
134 (50.067901611328): SELECT name FROM jos_deeppockets WHERE id=213
135 (793.9338684082): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))213((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
136 (735.04447937012): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))213((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
137 (124.93133544922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
138 (74.863433837891): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
139 (584.84077453613): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
140 (120.16296386719): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
141 (113.01040649414): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
142 (73.909759521484): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
143 (!!!!! 1931.90574646): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
144 (134.94491577148): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
145 (85.115432739258): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
146 (88.930130004883): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294745459 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294745459 AND type='deeppockets_item' AND published='1' LIMIT 1
147 (61.988830566406): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=213 or channel_id is null)
148 (51.975250244141): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=213 or channel_id is null)
149 (73.909759521484): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
150 (196.93374633789): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
151 (103.95050048828): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294745459 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294745459 AND published='1' LIMIT 1
152 (90.122222900391): select jos_twitters.link from jos_twitters where cat=10
153 (54.836273193359): select jos_facebook.link from jos_facebook where cat=10
154 (51.021575927734): select jos_google_plus.link from jos_google_plus where cat=10
155 (81.062316894531): select jos_linkedin.link from jos_linkedin where cat=10
156 (552.17742919922): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
157 (!!!!! 2188.2057189941): insert into jos_banners_delta values (14615,'2025-06-20 04:39:02','216.73.216.120','view'),(14202,'2025-06-20 04:39:02','216.73.216.120','view'),(14203,'2025-06-20 04:39:02','216.73.216.120','view')