Cardiothoracic Surgery

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

Fewer than one in 10 elderly patients with a low ejection fraction after myocardial infarction who are eligible to receive an implantable cardioverter-defibrillator actually receive one within a year of their myocardial infarction, a study has found.

The retrospective observational study of 10,318 patients aged over 65 years who had experienced a myocardial infarction and had an ejection fraction of 35% or less showed only 8.1% received an implantable cardioverter-defibrillator (ICD) within a year of their MI, even though implantation within a year was associated with a 36% reduction in mortality at 2 years.

Those patients who did receive an ICD were more likely to have had a prior coronary artery bypass graft, had higher peak troponin levels, experienced in-hospital cardiogenic shock, or had a cardiology follow-up within 2 weeks of discharge, according to the paper published June 23 in JAMA.

“Individualized shared decision making, taking into context the patient’s quality of life, treatment goals, and preferences, is critical, because ICD therapy may shift death from a sudden event to a more gradual comorbid process,” wrote Dr. Sean D. Pokorney, of Duke University Medical Center, Durham, N.C., and co-authors (JAMA 2015;313:2433-40 [doi: 10.1001/jama.2015.6409]).

The study was supported by the Agency for Healthcare Research& Quality, and Boston Scientific. Some authors declared research grants, honoraria, advisory board positions, and consultancies with private industry.

Fewer than one in 10 elderly patients with a low ejection fraction after myocardial infarction who are eligible to receive an implantable cardioverter-defibrillator actually receive one within a year of their myocardial infarction, a study has found.

The retrospective observational study of 10,318 patients aged over 65 years who had experienced a myocardial infarction and had an ejection fraction of 35% or less showed only 8.1% received an implantable cardioverter-defibrillator (ICD) within a year of their MI, even though implantation within a year was associated with a 36% reduction in mortality at 2 years.

Those patients who did receive an ICD were more likely to have had a prior coronary artery bypass graft, had higher peak troponin levels, experienced in-hospital cardiogenic shock, or had a cardiology follow-up within 2 weeks of discharge, according to the paper published June 23 in JAMA.

“Individualized shared decision making, taking into context the patient’s quality of life, treatment goals, and preferences, is critical, because ICD therapy may shift death from a sudden event to a more gradual comorbid process,” wrote Dr. Sean D. Pokorney, of Duke University Medical Center, Durham, N.C., and co-authors (JAMA 2015;313:2433-40 [doi: 10.1001/jama.2015.6409]).

The study was supported by the Agency for Healthcare Research& Quality, and Boston Scientific. Some authors declared research grants, honoraria, advisory board positions, and consultancies with private industry.

Fewer than one in 10 elderly patients with a low ejection fraction after myocardial infarction who are eligible to receive an implantable cardioverter-defibrillator actually receive one within a year of their myocardial infarction, a study has found.

The retrospective observational study of 10,318 patients aged over 65 years who had experienced a myocardial infarction and had an ejection fraction of 35% or less showed only 8.1% received an implantable cardioverter-defibrillator (ICD) within a year of their MI, even though implantation within a year was associated with a 36% reduction in mortality at 2 years.

Those patients who did receive an ICD were more likely to have had a prior coronary artery bypass graft, had higher peak troponin levels, experienced in-hospital cardiogenic shock, or had a cardiology follow-up within 2 weeks of discharge, according to the paper published June 23 in JAMA.

“Individualized shared decision making, taking into context the patient’s quality of life, treatment goals, and preferences, is critical, because ICD therapy may shift death from a sudden event to a more gradual comorbid process,” wrote Dr. Sean D. Pokorney, of Duke University Medical Center, Durham, N.C., and co-authors (JAMA 2015;313:2433-40 [doi: 10.1001/jama.2015.6409]).

The study was supported by the Agency for Healthcare Research& Quality, and Boston Scientific. Some authors declared research grants, honoraria, advisory board positions, and consultancies with private industry.

Poor communication remains at the heart of most surgical “never events” (i.e., preventable events), say the authors of a systematic review that estimates around 500 wrong-site surgeries and 5,000 retained surgical items incidents still happen each year in the United States.

The review of 138 empirical studies of wrong-site surgery, retained surgical items, and surgical fires, published between 2004 and 2014, found wrong-site surgery occurred roughly once per 100,000 surgical procedures, and retained surgical items incidents at a rate of 1.32 events per 10,000 procedures, with unknown data on the per-procedure incidence of surgical fire, according to data published online June 10 in JAMA Surgery.

©VILevi/thinkstockphotos.com

“A frequently reported cause of wrong-site surgery across 28 identified analyses was communication problems, including miscommunications among staff, missing information that should have been available to the operating room staff, surgical team members not speaking up when they noticed that a procedure targeted the wrong side, and a surgeon ignoring surgical team members who questioned laterality,” wrote Susanne Hempel, PhD, of the Southern California Evidence-Based Practice Center, Santa Monica, and her coauthors.

They found that very few evaluations of interventions designed specifically to reduce the incidence of never events were conclusive, although they pointed out that given the rarity of these events, it was methodologically challenging to assess the effectiveness of these interventions (JAMA Surg. 2015 June 10 [doi:10.1001/jamasurg.2015.0301]).

The Department of Veterans Affairs supported the study. There were no conflicts of interest declared.

Poor communication remains at the heart of most surgical “never events” (i.e., preventable events), say the authors of a systematic review that estimates around 500 wrong-site surgeries and 5,000 retained surgical items incidents still happen each year in the United States.

The review of 138 empirical studies of wrong-site surgery, retained surgical items, and surgical fires, published between 2004 and 2014, found wrong-site surgery occurred roughly once per 100,000 surgical procedures, and retained surgical items incidents at a rate of 1.32 events per 10,000 procedures, with unknown data on the per-procedure incidence of surgical fire, according to data published online June 10 in JAMA Surgery.

©VILevi/thinkstockphotos.com

“A frequently reported cause of wrong-site surgery across 28 identified analyses was communication problems, including miscommunications among staff, missing information that should have been available to the operating room staff, surgical team members not speaking up when they noticed that a procedure targeted the wrong side, and a surgeon ignoring surgical team members who questioned laterality,” wrote Susanne Hempel, PhD, of the Southern California Evidence-Based Practice Center, Santa Monica, and her coauthors.

They found that very few evaluations of interventions designed specifically to reduce the incidence of never events were conclusive, although they pointed out that given the rarity of these events, it was methodologically challenging to assess the effectiveness of these interventions (JAMA Surg. 2015 June 10 [doi:10.1001/jamasurg.2015.0301]).

The Department of Veterans Affairs supported the study. There were no conflicts of interest declared.

Poor communication remains at the heart of most surgical “never events” (i.e., preventable events), say the authors of a systematic review that estimates around 500 wrong-site surgeries and 5,000 retained surgical items incidents still happen each year in the United States.

The review of 138 empirical studies of wrong-site surgery, retained surgical items, and surgical fires, published between 2004 and 2014, found wrong-site surgery occurred roughly once per 100,000 surgical procedures, and retained surgical items incidents at a rate of 1.32 events per 10,000 procedures, with unknown data on the per-procedure incidence of surgical fire, according to data published online June 10 in JAMA Surgery.

©VILevi/thinkstockphotos.com

“A frequently reported cause of wrong-site surgery across 28 identified analyses was communication problems, including miscommunications among staff, missing information that should have been available to the operating room staff, surgical team members not speaking up when they noticed that a procedure targeted the wrong side, and a surgeon ignoring surgical team members who questioned laterality,” wrote Susanne Hempel, PhD, of the Southern California Evidence-Based Practice Center, Santa Monica, and her coauthors.

They found that very few evaluations of interventions designed specifically to reduce the incidence of never events were conclusive, although they pointed out that given the rarity of these events, it was methodologically challenging to assess the effectiveness of these interventions (JAMA Surg. 2015 June 10 [doi:10.1001/jamasurg.2015.0301]).

The Department of Veterans Affairs supported the study. There were no conflicts of interest declared.

BOSTON – An implantable cardioverter defibrillator device that can safely undergo magnetic resonance imaging may soon be a commercial reality as two different models from two different manufacturers showed safety and mostly uncompromised efficacy during and after MRI in two separate studies reported at the annual scientific sessions of the Heart Rhythm Society.

The impending availability of two different brands of implantable cardioverter defibrillators (ICDs) that allow patients to safely undergo MRI “will hopefully open a new era when most [ICDs] are designed” to be MRI safe, said Dr. Khaled A. Awad, an electrophysiologist at the University of Alabama at Birmingham, and lead investigator for one of the new studies.

“Within 10 years, all ICDs getting implanted will be MRI compatible,” predicted Dr. Michael R. Gold, chief of cardiology and medical director of the heart and vascular center at the Medical University of South Carolina in Charleston and lead investigator for the second study.

Until now, having an ICD in a patient created a contraindication for using MRI on the patient, a situation that would change once MRI-safe ICDs become routinely available, noted Dr. Gold. MRI-compatible implanted pacemakers have been on the U.S. market since 2011; ICDs able to safely undergo MRI exposure became the next frontier for creating implanted cardiovascular devices that allow MRIs. Both studies used MRI performed with a 1.5-T magnetic field, a strength commonly used in routine practice today.

The ProMRI study reported by Dr. Awad enrolled patients at 39 U.S. centers who at least 5 weeks previously had received an Iforia ICD made by Biotronik along with commercially available leads believed to be MRI safe. The researchers performed MRIs of the heart or thoracic spine on 154 patients, and then ran follow-up examinations on 150 patients 1 month after the MRI, and a second, 3-month follow-up on 92 of the enrolled patients. The study did not include any control patients who received the ICD and did not undergo MRI.

No patient had an adverse event related or possibly related to their ICD either at the time of the MRI or at follow-up, Dr. Awad reported. In addition, no patients had a significant change in their ICD’s ventricular capture threshold, and one patient had a significant change in the ICD’s ventricular sensing. During follow-up, the ICDs of enrolled patients detected a total of 403 ventricular arrhythmias in 39 patients, with all these episodes appropriately detected and treated.

The study reported by Dr. Gold enrolled patients at 42 centers in 13 countries including the United States. The investigators implanted ICDs into 263 patients using commercially available leads, and then 9-12 weeks after placement, they randomized patients at a 2:1 rate to either undergo MRI or receive no MRI and serve as controls. Of the 175 patients randomized to undergo MRI, 156 actually received the examination, a full-body examination, and 147 participated in follow-up to at least 1 month and were part of the safety analysis.

Patient follow-up showed no complications, no episodes of a significant change in ventricular-pacing sensing threshold, and one episode of a significant change in ventricular-sensing amplitude, Dr. Gold reported, showing safety and efficacy outcomes identical to those in the trial of the Biotronik device. During follow-up 34 episodes of ventricular tachycardia or fibrillation occurred in 24 patients in the MRI group, and the implanted ICDs detected and treated all episodes appropriately. Concurrent with Dr. Gold’s report, the results also appeared in an article published online (J. Am. Coll. Cardiol. 2015 [doi:10.1016/j.jacc.2015.04.047]).

[email protected]
On Twitter @mitchelzoler 

BOSTON – An implantable cardioverter defibrillator device that can safely undergo magnetic resonance imaging may soon be a commercial reality as two different models from two different manufacturers showed safety and mostly uncompromised efficacy during and after MRI in two separate studies reported at the annual scientific sessions of the Heart Rhythm Society.

The impending availability of two different brands of implantable cardioverter defibrillators (ICDs) that allow patients to safely undergo MRI “will hopefully open a new era when most [ICDs] are designed” to be MRI safe, said Dr. Khaled A. Awad, an electrophysiologist at the University of Alabama at Birmingham, and lead investigator for one of the new studies.

“Within 10 years, all ICDs getting implanted will be MRI compatible,” predicted Dr. Michael R. Gold, chief of cardiology and medical director of the heart and vascular center at the Medical University of South Carolina in Charleston and lead investigator for the second study.

Until now, having an ICD in a patient created a contraindication for using MRI on the patient, a situation that would change once MRI-safe ICDs become routinely available, noted Dr. Gold. MRI-compatible implanted pacemakers have been on the U.S. market since 2011; ICDs able to safely undergo MRI exposure became the next frontier for creating implanted cardiovascular devices that allow MRIs. Both studies used MRI performed with a 1.5-T magnetic field, a strength commonly used in routine practice today.

The ProMRI study reported by Dr. Awad enrolled patients at 39 U.S. centers who at least 5 weeks previously had received an Iforia ICD made by Biotronik along with commercially available leads believed to be MRI safe. The researchers performed MRIs of the heart or thoracic spine on 154 patients, and then ran follow-up examinations on 150 patients 1 month after the MRI, and a second, 3-month follow-up on 92 of the enrolled patients. The study did not include any control patients who received the ICD and did not undergo MRI.

No patient had an adverse event related or possibly related to their ICD either at the time of the MRI or at follow-up, Dr. Awad reported. In addition, no patients had a significant change in their ICD’s ventricular capture threshold, and one patient had a significant change in the ICD’s ventricular sensing. During follow-up, the ICDs of enrolled patients detected a total of 403 ventricular arrhythmias in 39 patients, with all these episodes appropriately detected and treated.

The study reported by Dr. Gold enrolled patients at 42 centers in 13 countries including the United States. The investigators implanted ICDs into 263 patients using commercially available leads, and then 9-12 weeks after placement, they randomized patients at a 2:1 rate to either undergo MRI or receive no MRI and serve as controls. Of the 175 patients randomized to undergo MRI, 156 actually received the examination, a full-body examination, and 147 participated in follow-up to at least 1 month and were part of the safety analysis.

Patient follow-up showed no complications, no episodes of a significant change in ventricular-pacing sensing threshold, and one episode of a significant change in ventricular-sensing amplitude, Dr. Gold reported, showing safety and efficacy outcomes identical to those in the trial of the Biotronik device. During follow-up 34 episodes of ventricular tachycardia or fibrillation occurred in 24 patients in the MRI group, and the implanted ICDs detected and treated all episodes appropriately. Concurrent with Dr. Gold’s report, the results also appeared in an article published online (J. Am. Coll. Cardiol. 2015 [doi:10.1016/j.jacc.2015.04.047]).

[email protected]
On Twitter @mitchelzoler 

BOSTON – An implantable cardioverter defibrillator device that can safely undergo magnetic resonance imaging may soon be a commercial reality as two different models from two different manufacturers showed safety and mostly uncompromised efficacy during and after MRI in two separate studies reported at the annual scientific sessions of the Heart Rhythm Society.

The impending availability of two different brands of implantable cardioverter defibrillators (ICDs) that allow patients to safely undergo MRI “will hopefully open a new era when most [ICDs] are designed” to be MRI safe, said Dr. Khaled A. Awad, an electrophysiologist at the University of Alabama at Birmingham, and lead investigator for one of the new studies.

“Within 10 years, all ICDs getting implanted will be MRI compatible,” predicted Dr. Michael R. Gold, chief of cardiology and medical director of the heart and vascular center at the Medical University of South Carolina in Charleston and lead investigator for the second study.

Until now, having an ICD in a patient created a contraindication for using MRI on the patient, a situation that would change once MRI-safe ICDs become routinely available, noted Dr. Gold. MRI-compatible implanted pacemakers have been on the U.S. market since 2011; ICDs able to safely undergo MRI exposure became the next frontier for creating implanted cardiovascular devices that allow MRIs. Both studies used MRI performed with a 1.5-T magnetic field, a strength commonly used in routine practice today.

The ProMRI study reported by Dr. Awad enrolled patients at 39 U.S. centers who at least 5 weeks previously had received an Iforia ICD made by Biotronik along with commercially available leads believed to be MRI safe. The researchers performed MRIs of the heart or thoracic spine on 154 patients, and then ran follow-up examinations on 150 patients 1 month after the MRI, and a second, 3-month follow-up on 92 of the enrolled patients. The study did not include any control patients who received the ICD and did not undergo MRI.

No patient had an adverse event related or possibly related to their ICD either at the time of the MRI or at follow-up, Dr. Awad reported. In addition, no patients had a significant change in their ICD’s ventricular capture threshold, and one patient had a significant change in the ICD’s ventricular sensing. During follow-up, the ICDs of enrolled patients detected a total of 403 ventricular arrhythmias in 39 patients, with all these episodes appropriately detected and treated.

The study reported by Dr. Gold enrolled patients at 42 centers in 13 countries including the United States. The investigators implanted ICDs into 263 patients using commercially available leads, and then 9-12 weeks after placement, they randomized patients at a 2:1 rate to either undergo MRI or receive no MRI and serve as controls. Of the 175 patients randomized to undergo MRI, 156 actually received the examination, a full-body examination, and 147 participated in follow-up to at least 1 month and were part of the safety analysis.

Patient follow-up showed no complications, no episodes of a significant change in ventricular-pacing sensing threshold, and one episode of a significant change in ventricular-sensing amplitude, Dr. Gold reported, showing safety and efficacy outcomes identical to those in the trial of the Biotronik device. During follow-up 34 episodes of ventricular tachycardia or fibrillation occurred in 24 patients in the MRI group, and the implanted ICDs detected and treated all episodes appropriately. Concurrent with Dr. Gold’s report, the results also appeared in an article published online (J. Am. Coll. Cardiol. 2015 [doi:10.1016/j.jacc.2015.04.047]).

[email protected]
On Twitter @mitchelzoler 

SEATTLE – Aortic valve–sparing procedures have better outcomes than Bentall procedures with biologic or mechanical valves, according to a review of 1,187 aortic root cases at the University of Toronto.

“If the aortic valve can be spared, AVS [aortic valve–sparing] procedures should be considered for patients undergoing aortic root replacement,” concluded the investigators, led by Dr. Maral Ouzounian, a cardiovascular surgeon at the university.

Alex Otto/Frontline Medical News

The team reviewed surgical outcomes there from 1990 to 2010; 282 patients had AVS procedures, 562 had Bentall procedures with biologic valve replacements (b-Bentall); and 343 had Bentalls with mechanical valve replacements (m-Bentall). About 7.5% of AVS patients had bicuspid aortic valves, versus 67.6% in the b-Bentall group and 51.7% in the m-Bentall group.

To control for confounders, patients were matched into 185 triads based on age, year of surgery, and stage of heart failure. The surgeries were all elective; patients with endocarditis or aortic dissections were excluded from the analysis.

Early postoperative outcomes and overall long-term survival were similar between the groups, with about 80% of patients in all three alive at 15-year follow-up.

However, AVS procedures had better long-term freedom from cardiac death (95% at 15 years versus 93% in the b-Bentall and 90% in the m-Bentall groups). Also, AVS patients had lower rates of anticoagulant-related hemorrhages, compared with m-Bentall patients (3.2% versus 17.8%), and lower rates of structural valve deterioration (0% versus 6.5%) and reoperations (6.5% versus 13.5%) than b-Bentall patients. The differences were statistically significant.

About 5% of AVS patients had previous cardiac surgery, versus 12.4% in the b-Bentall and 36.2% in the m-Bentall groups. AVS patients were more likely to have Marfan syndrome, and about 8% of AVS patients had preoperative ejection fractions below 40%, versus 9.3% in the b-Bentall and 13% in the m-Bentall groups. There were no between-group differences in the rates of concomitant coronary bypass or mitral valve surgery. Patients were about 50 years old on average, and about 80% were men.

“In Toronto, we are quite aggressive with valve-sparing operations. We believe in this operation, so whenever we can spare the valve, we do.” Although valve-sparing procedures have become more common in large, high-volume surgery centers over the past 20 years, “community surgeons in small-volume centers are still much more likely to do a Bentall because of the complexity of AVS operations and the art it takes to get it right,” Dr. Ouzounian said at the annual meeting of the American Association for Thoracic Surgery.

Previous investigations have found benefits for AVS procedures, as well. One concluded that “there is no significant difference in terms of re-operation between patients, who presented with [bicuspid or tricuspid aortic valves]. Re-operation rates are higher for patients who presented with severe [aortic regurgitation], but these rates do not reach statistical significance. Hence, root replacement with aortic valve sparing should be offered even in the presence of a” bicuspid aortic valve or severe aortic regurgitation (Eur. J. Cardiothorac. Surg. 2010;38:515-22).

Dr. Ouzounian said she has no disclosures.

[email protected]

SEATTLE – Aortic valve–sparing procedures have better outcomes than Bentall procedures with biologic or mechanical valves, according to a review of 1,187 aortic root cases at the University of Toronto.

“If the aortic valve can be spared, AVS [aortic valve–sparing] procedures should be considered for patients undergoing aortic root replacement,” concluded the investigators, led by Dr. Maral Ouzounian, a cardiovascular surgeon at the university.

Alex Otto/Frontline Medical News

The team reviewed surgical outcomes there from 1990 to 2010; 282 patients had AVS procedures, 562 had Bentall procedures with biologic valve replacements (b-Bentall); and 343 had Bentalls with mechanical valve replacements (m-Bentall). About 7.5% of AVS patients had bicuspid aortic valves, versus 67.6% in the b-Bentall group and 51.7% in the m-Bentall group.

To control for confounders, patients were matched into 185 triads based on age, year of surgery, and stage of heart failure. The surgeries were all elective; patients with endocarditis or aortic dissections were excluded from the analysis.

Early postoperative outcomes and overall long-term survival were similar between the groups, with about 80% of patients in all three alive at 15-year follow-up.

However, AVS procedures had better long-term freedom from cardiac death (95% at 15 years versus 93% in the b-Bentall and 90% in the m-Bentall groups). Also, AVS patients had lower rates of anticoagulant-related hemorrhages, compared with m-Bentall patients (3.2% versus 17.8%), and lower rates of structural valve deterioration (0% versus 6.5%) and reoperations (6.5% versus 13.5%) than b-Bentall patients. The differences were statistically significant.

About 5% of AVS patients had previous cardiac surgery, versus 12.4% in the b-Bentall and 36.2% in the m-Bentall groups. AVS patients were more likely to have Marfan syndrome, and about 8% of AVS patients had preoperative ejection fractions below 40%, versus 9.3% in the b-Bentall and 13% in the m-Bentall groups. There were no between-group differences in the rates of concomitant coronary bypass or mitral valve surgery. Patients were about 50 years old on average, and about 80% were men.

“In Toronto, we are quite aggressive with valve-sparing operations. We believe in this operation, so whenever we can spare the valve, we do.” Although valve-sparing procedures have become more common in large, high-volume surgery centers over the past 20 years, “community surgeons in small-volume centers are still much more likely to do a Bentall because of the complexity of AVS operations and the art it takes to get it right,” Dr. Ouzounian said at the annual meeting of the American Association for Thoracic Surgery.

Previous investigations have found benefits for AVS procedures, as well. One concluded that “there is no significant difference in terms of re-operation between patients, who presented with [bicuspid or tricuspid aortic valves]. Re-operation rates are higher for patients who presented with severe [aortic regurgitation], but these rates do not reach statistical significance. Hence, root replacement with aortic valve sparing should be offered even in the presence of a” bicuspid aortic valve or severe aortic regurgitation (Eur. J. Cardiothorac. Surg. 2010;38:515-22).

Dr. Ouzounian said she has no disclosures.

[email protected]

SEATTLE – Aortic valve–sparing procedures have better outcomes than Bentall procedures with biologic or mechanical valves, according to a review of 1,187 aortic root cases at the University of Toronto.

“If the aortic valve can be spared, AVS [aortic valve–sparing] procedures should be considered for patients undergoing aortic root replacement,” concluded the investigators, led by Dr. Maral Ouzounian, a cardiovascular surgeon at the university.

Alex Otto/Frontline Medical News

The team reviewed surgical outcomes there from 1990 to 2010; 282 patients had AVS procedures, 562 had Bentall procedures with biologic valve replacements (b-Bentall); and 343 had Bentalls with mechanical valve replacements (m-Bentall). About 7.5% of AVS patients had bicuspid aortic valves, versus 67.6% in the b-Bentall group and 51.7% in the m-Bentall group.

To control for confounders, patients were matched into 185 triads based on age, year of surgery, and stage of heart failure. The surgeries were all elective; patients with endocarditis or aortic dissections were excluded from the analysis.

Early postoperative outcomes and overall long-term survival were similar between the groups, with about 80% of patients in all three alive at 15-year follow-up.

However, AVS procedures had better long-term freedom from cardiac death (95% at 15 years versus 93% in the b-Bentall and 90% in the m-Bentall groups). Also, AVS patients had lower rates of anticoagulant-related hemorrhages, compared with m-Bentall patients (3.2% versus 17.8%), and lower rates of structural valve deterioration (0% versus 6.5%) and reoperations (6.5% versus 13.5%) than b-Bentall patients. The differences were statistically significant.

About 5% of AVS patients had previous cardiac surgery, versus 12.4% in the b-Bentall and 36.2% in the m-Bentall groups. AVS patients were more likely to have Marfan syndrome, and about 8% of AVS patients had preoperative ejection fractions below 40%, versus 9.3% in the b-Bentall and 13% in the m-Bentall groups. There were no between-group differences in the rates of concomitant coronary bypass or mitral valve surgery. Patients were about 50 years old on average, and about 80% were men.

“In Toronto, we are quite aggressive with valve-sparing operations. We believe in this operation, so whenever we can spare the valve, we do.” Although valve-sparing procedures have become more common in large, high-volume surgery centers over the past 20 years, “community surgeons in small-volume centers are still much more likely to do a Bentall because of the complexity of AVS operations and the art it takes to get it right,” Dr. Ouzounian said at the annual meeting of the American Association for Thoracic Surgery.

Previous investigations have found benefits for AVS procedures, as well. One concluded that “there is no significant difference in terms of re-operation between patients, who presented with [bicuspid or tricuspid aortic valves]. Re-operation rates are higher for patients who presented with severe [aortic regurgitation], but these rates do not reach statistical significance. Hence, root replacement with aortic valve sparing should be offered even in the presence of a” bicuspid aortic valve or severe aortic regurgitation (Eur. J. Cardiothorac. Surg. 2010;38:515-22).

Dr. Ouzounian said she has no disclosures.

[email protected]

SEATTLE – Thoracic duct ligation did not seem to prevent chylothorax in a review of 827 esophagectomy cases at Brigham and Women’s Hospital in Boston.

In fact, chylothorax was most likely in patients who had mass ligation of the duct and its surrounding soft tissue, instead of ligation of simply the duct itself.

The results are surprising because ligation is actually meant to prevent chylothorax, but “it didn’t serve that purpose,” said lead investigator Dr. Yifan Zheng, a clinical research fellow at the hospital.

Results have been mixed in previous studies of ligation, with some finding benefit for preventing chylothorax but others not. With contradictory evidence, some surgeons – including some in the Brigham and Women’s review, which covered 11 years of data – opt for routine ligation, while others don’t, Dr. Zheng said at the annual meeting of the American Association for Thoracic Surgery.

At this point, “if you see the thoracic duct and you have concerns about ductal injury, your best bet is to ligate the duct directly. We observed in our series that there is a significantly higher incidence of chylothorax” with mass ligation, she said.

Of the 827 esophagectomies, 635 were performed without thoracic duct ligation; 33 (5.2%) cases developed postop chylothorax. Among the 56 cases with explicit identification and ligation of the thoracic duct alone, chylothorax developed in four (7.1%). There were 136 esophagectomies with mass ligation; 27 (19.9%) developed chylothorax (P = .0314).

The majority of the ligations were performed during open procedures. Mass ligations were mostly done with surgical sutures, while clips were used for direct ductal ligations. It’s likely that surgeons opted for direct ligation when they could see the duct and mass ligation when they could not.

Esophagectomy patients in the study were largely the same, so it’s unclear why some were ligated but others were not. About 75% in both groups had adenocarcinomas, most of which were in the distal esophagus or gastroesophageal junction. About half of the ligated group had preop chemoradiation, versus about 60% in the nonligated group.

Patients who developed postop chyle leaks were also similar, whether or not they were ligated. Most had adenocarcinomas in the distal esophagus or gastroesophageal junction, and the majority had received neoadjuvant therapy. “It’s unlikely that operative approach influenced the development of chylothorax,” Dr. Zheng said.

Both ligated and nonligated patients responded well to chylothorax management. Of the 64 total cases, 28 were successfully treated by thoracic duct embolization and 20 were successfully treated by operative thoracic duct ligation. In 10 cases, thoracic duct embolization was attempted but unsuccessful and all were successfully treated with operative ligation. Six cases were managed with chest tube drainage and total parenteral nutrition. It is possible that patients were ligated because they appeared during surgery to be at risk for postop chylothorax, which would help explain the findings.

It also is possible, however, that ligation itself – especially mass ligation – increases the risk. “The thoracic duct is a high-pressure system, so [blocking it] could create a pressure buildup and a potential leak,” Dr. Zheng said. That might be especially true with mass ligation, when both the thoracic duct and its tributaries are tied off.

Dr. Zheng said that she had no relevant disclosures.

[email protected]

SEATTLE – Thoracic duct ligation did not seem to prevent chylothorax in a review of 827 esophagectomy cases at Brigham and Women’s Hospital in Boston.

In fact, chylothorax was most likely in patients who had mass ligation of the duct and its surrounding soft tissue, instead of ligation of simply the duct itself.

The results are surprising because ligation is actually meant to prevent chylothorax, but “it didn’t serve that purpose,” said lead investigator Dr. Yifan Zheng, a clinical research fellow at the hospital.

Results have been mixed in previous studies of ligation, with some finding benefit for preventing chylothorax but others not. With contradictory evidence, some surgeons – including some in the Brigham and Women’s review, which covered 11 years of data – opt for routine ligation, while others don’t, Dr. Zheng said at the annual meeting of the American Association for Thoracic Surgery.

At this point, “if you see the thoracic duct and you have concerns about ductal injury, your best bet is to ligate the duct directly. We observed in our series that there is a significantly higher incidence of chylothorax” with mass ligation, she said.

Of the 827 esophagectomies, 635 were performed without thoracic duct ligation; 33 (5.2%) cases developed postop chylothorax. Among the 56 cases with explicit identification and ligation of the thoracic duct alone, chylothorax developed in four (7.1%). There were 136 esophagectomies with mass ligation; 27 (19.9%) developed chylothorax (P = .0314).

The majority of the ligations were performed during open procedures. Mass ligations were mostly done with surgical sutures, while clips were used for direct ductal ligations. It’s likely that surgeons opted for direct ligation when they could see the duct and mass ligation when they could not.

Esophagectomy patients in the study were largely the same, so it’s unclear why some were ligated but others were not. About 75% in both groups had adenocarcinomas, most of which were in the distal esophagus or gastroesophageal junction. About half of the ligated group had preop chemoradiation, versus about 60% in the nonligated group.

Patients who developed postop chyle leaks were also similar, whether or not they were ligated. Most had adenocarcinomas in the distal esophagus or gastroesophageal junction, and the majority had received neoadjuvant therapy. “It’s unlikely that operative approach influenced the development of chylothorax,” Dr. Zheng said.

Both ligated and nonligated patients responded well to chylothorax management. Of the 64 total cases, 28 were successfully treated by thoracic duct embolization and 20 were successfully treated by operative thoracic duct ligation. In 10 cases, thoracic duct embolization was attempted but unsuccessful and all were successfully treated with operative ligation. Six cases were managed with chest tube drainage and total parenteral nutrition. It is possible that patients were ligated because they appeared during surgery to be at risk for postop chylothorax, which would help explain the findings.

It also is possible, however, that ligation itself – especially mass ligation – increases the risk. “The thoracic duct is a high-pressure system, so [blocking it] could create a pressure buildup and a potential leak,” Dr. Zheng said. That might be especially true with mass ligation, when both the thoracic duct and its tributaries are tied off.

Dr. Zheng said that she had no relevant disclosures.

[email protected]

SEATTLE – Thoracic duct ligation did not seem to prevent chylothorax in a review of 827 esophagectomy cases at Brigham and Women’s Hospital in Boston.

In fact, chylothorax was most likely in patients who had mass ligation of the duct and its surrounding soft tissue, instead of ligation of simply the duct itself.

The results are surprising because ligation is actually meant to prevent chylothorax, but “it didn’t serve that purpose,” said lead investigator Dr. Yifan Zheng, a clinical research fellow at the hospital.

Results have been mixed in previous studies of ligation, with some finding benefit for preventing chylothorax but others not. With contradictory evidence, some surgeons – including some in the Brigham and Women’s review, which covered 11 years of data – opt for routine ligation, while others don’t, Dr. Zheng said at the annual meeting of the American Association for Thoracic Surgery.

At this point, “if you see the thoracic duct and you have concerns about ductal injury, your best bet is to ligate the duct directly. We observed in our series that there is a significantly higher incidence of chylothorax” with mass ligation, she said.

Of the 827 esophagectomies, 635 were performed without thoracic duct ligation; 33 (5.2%) cases developed postop chylothorax. Among the 56 cases with explicit identification and ligation of the thoracic duct alone, chylothorax developed in four (7.1%). There were 136 esophagectomies with mass ligation; 27 (19.9%) developed chylothorax (P = .0314).

The majority of the ligations were performed during open procedures. Mass ligations were mostly done with surgical sutures, while clips were used for direct ductal ligations. It’s likely that surgeons opted for direct ligation when they could see the duct and mass ligation when they could not.

Esophagectomy patients in the study were largely the same, so it’s unclear why some were ligated but others were not. About 75% in both groups had adenocarcinomas, most of which were in the distal esophagus or gastroesophageal junction. About half of the ligated group had preop chemoradiation, versus about 60% in the nonligated group.

Patients who developed postop chyle leaks were also similar, whether or not they were ligated. Most had adenocarcinomas in the distal esophagus or gastroesophageal junction, and the majority had received neoadjuvant therapy. “It’s unlikely that operative approach influenced the development of chylothorax,” Dr. Zheng said.

Both ligated and nonligated patients responded well to chylothorax management. Of the 64 total cases, 28 were successfully treated by thoracic duct embolization and 20 were successfully treated by operative thoracic duct ligation. In 10 cases, thoracic duct embolization was attempted but unsuccessful and all were successfully treated with operative ligation. Six cases were managed with chest tube drainage and total parenteral nutrition. It is possible that patients were ligated because they appeared during surgery to be at risk for postop chylothorax, which would help explain the findings.

It also is possible, however, that ligation itself – especially mass ligation – increases the risk. “The thoracic duct is a high-pressure system, so [blocking it] could create a pressure buildup and a potential leak,” Dr. Zheng said. That might be especially true with mass ligation, when both the thoracic duct and its tributaries are tied off.

Dr. Zheng said that she had no relevant disclosures.

[email protected]

BOSTON – The problem-plagued St. Jude Riata leads for implantable cardioverter defibrillators, pulled from the U.S. market in 2010, continue to pose problems for the tens of thousands of patients who still have them as clinicians follow these patients out to periods approaching 10 years.

But the risks of lead extraction continue make prophylactic lead removal a poor option for most patients, leaving the alternative of continuing to closely monitor patients for episodes of electrical lead failure, Dr. Ratika Parkash said at the annual scientific sessions of the Heart Rhythm Society.

Mitchel L. Zoler/Frontline Medical News

“Isolated, prophylactic lead revision or extraction is not warranted,” said Dr. Parkash, a cardiac electrophysiologist at Dalhousie University in Halifax, Canada. “We need to take into account a patient’s comorbidities compared with the possibility of cable externalization,” when the conducting cable of the lead moves outside its insulating sheath, one of the main problems with the St. Jude Riata leads, she explained. “I think we need to individualize what we do” based on each patient’s specific situation, but perhaps collecting more data during another 2 years follow-up might shed more light on this issue, she said. Dr. Parkash and her associates followed Riata-lead recipients for an average of 7.5 years to produce the current report.

Although no U.S. patient has received a Riata lead for nearly 5 years, the Food and Drug Administration estimated that at the time St. Jude stopped selling this lead in late 2010 more than 227,000 Riata leads had gone into patients worldwide, including about 79,000 U.S. patients. Last February, St. Jude announced that it had settled 950 lawsuits or claims from U.S. patients who had received Riata leads.

The CREDO (Canadian Registry of Cardiac Implantable Electronic Device Outcomes) prospective registry review reported by Dr. Parkash included data from 2,707 patients who received Riata leads at any of 15 Canadian centers, representing 60% of the 4,538 Canadian residents who had received on of these leads. The patients averaged 63 years of age, 19% were women, 70% had received an 8 French lead and 30% had received a 7F lead, and follow-up data were available for an average of 7.5 years from the time patients received the leads to attach their implantable cardioverter defibrillator (ICD) to their heart.

Mitchel L. Zoler/Frontline Medical News

During follow-up, 378 of the 2,707 patients (14%) required revision of their leads, a rate well above the rates seen collectively for all ICD lead models in data collected in both randomized trials and in the U.S. national registry of ICD implantations maintained by the National Cardiovascular Data Registry (OpenHeart 2015;2: [doi:10.1136/openhrt-2014-000198]). The rate of lead revisions seen with the Riata lead, 14% during 7.5 years follow-up, puts it in the ballpark of the 17% lead-failure rate with 5 year follow-up seen in Canadian patients who received a Sprint Fidelis lead that was marketed by Medtronic.(Circulation 2012:1217-25)

Triggering the 378 Riata revisions were electrical abnormalities, in 42%, lead dislodgement in 18%, cable externalization in 12%, infection in 12%, and several other types of events causing the other revisions.

The rate of electrical failures remained steady throughout follow-up, averaging about 0.8%/ year for both the 8F leads, which the researchers could follow for up to 10 years, and for the 7F leads, which they followed out to as long as 8 years. Cable externalizations occurred in 7% of the 8F leads and in 5% of the 7F leads, a difference that was not statistically significant. Fewer than half the patients, 1,187 (44%) underwent radiographic assessment of cable externalization. About 90% of all the detected cable externalizations in both the 7F and 8F leads did not produce electrical failure.

A multivariate analysis identified two factors independently linked with lead failure: patient age and left ventricular ejection fraction. Every 10 years of additional patient age linked with a 16% reduced rate of lead failure. And every 10% in additional ejection fraction linked with a 26% increased rate of lead failure.

The Canadian experience also documented the risk of undergoing lead revision, which happened for 253 patients and which led to 16 major complications, a 6% rate. Fifteen of the 16 major complications occurred without lead extraction taking place. Also, the major complications occurred at roughly similar rates in patients with 7F or 8F leads.

Dr. Parkash also highlighted that cable externalization often occurs late after implantation, and so additional cases are still possible. “We may just be seeing the cusp of lead failure” in the data collected so far, she suggested.

One concern the new data did not stoke is the risk for lead shorting that produces sudden ICD failure. “I think [shorting] is not as much of a problem as we previously thought,” Dr. Parkash said.

“These data give credence to the strategy of keeping the Riata leads in place, and, if you are concerned about their function, capping them and putting in a new lead,” commented Dr. Fred M. Kusumoto, an electrophysiologist and professor of medicine at the Mayo Clinic, Florida in Jacksonville. In addition, the new data demonstrate that the problem is in both the 7F as well as the 8F leads. “The entire Riata design was not very good,” he said in an interview. But a reassuring result in the Canadian registry was the low rate of shorting, or high-voltage failure of the lead, Dr. Kusumoto said.

[email protected]

On Twitter @mitchelzoler

BOSTON – The problem-plagued St. Jude Riata leads for implantable cardioverter defibrillators, pulled from the U.S. market in 2010, continue to pose problems for the tens of thousands of patients who still have them as clinicians follow these patients out to periods approaching 10 years.

But the risks of lead extraction continue make prophylactic lead removal a poor option for most patients, leaving the alternative of continuing to closely monitor patients for episodes of electrical lead failure, Dr. Ratika Parkash said at the annual scientific sessions of the Heart Rhythm Society.

Mitchel L. Zoler/Frontline Medical News

“Isolated, prophylactic lead revision or extraction is not warranted,” said Dr. Parkash, a cardiac electrophysiologist at Dalhousie University in Halifax, Canada. “We need to take into account a patient’s comorbidities compared with the possibility of cable externalization,” when the conducting cable of the lead moves outside its insulating sheath, one of the main problems with the St. Jude Riata leads, she explained. “I think we need to individualize what we do” based on each patient’s specific situation, but perhaps collecting more data during another 2 years follow-up might shed more light on this issue, she said. Dr. Parkash and her associates followed Riata-lead recipients for an average of 7.5 years to produce the current report.

Although no U.S. patient has received a Riata lead for nearly 5 years, the Food and Drug Administration estimated that at the time St. Jude stopped selling this lead in late 2010 more than 227,000 Riata leads had gone into patients worldwide, including about 79,000 U.S. patients. Last February, St. Jude announced that it had settled 950 lawsuits or claims from U.S. patients who had received Riata leads.

The CREDO (Canadian Registry of Cardiac Implantable Electronic Device Outcomes) prospective registry review reported by Dr. Parkash included data from 2,707 patients who received Riata leads at any of 15 Canadian centers, representing 60% of the 4,538 Canadian residents who had received on of these leads. The patients averaged 63 years of age, 19% were women, 70% had received an 8 French lead and 30% had received a 7F lead, and follow-up data were available for an average of 7.5 years from the time patients received the leads to attach their implantable cardioverter defibrillator (ICD) to their heart.

Mitchel L. Zoler/Frontline Medical News

During follow-up, 378 of the 2,707 patients (14%) required revision of their leads, a rate well above the rates seen collectively for all ICD lead models in data collected in both randomized trials and in the U.S. national registry of ICD implantations maintained by the National Cardiovascular Data Registry (OpenHeart 2015;2: [doi:10.1136/openhrt-2014-000198]). The rate of lead revisions seen with the Riata lead, 14% during 7.5 years follow-up, puts it in the ballpark of the 17% lead-failure rate with 5 year follow-up seen in Canadian patients who received a Sprint Fidelis lead that was marketed by Medtronic.(Circulation 2012:1217-25)

Triggering the 378 Riata revisions were electrical abnormalities, in 42%, lead dislodgement in 18%, cable externalization in 12%, infection in 12%, and several other types of events causing the other revisions.

The rate of electrical failures remained steady throughout follow-up, averaging about 0.8%/ year for both the 8F leads, which the researchers could follow for up to 10 years, and for the 7F leads, which they followed out to as long as 8 years. Cable externalizations occurred in 7% of the 8F leads and in 5% of the 7F leads, a difference that was not statistically significant. Fewer than half the patients, 1,187 (44%) underwent radiographic assessment of cable externalization. About 90% of all the detected cable externalizations in both the 7F and 8F leads did not produce electrical failure.

A multivariate analysis identified two factors independently linked with lead failure: patient age and left ventricular ejection fraction. Every 10 years of additional patient age linked with a 16% reduced rate of lead failure. And every 10% in additional ejection fraction linked with a 26% increased rate of lead failure.

The Canadian experience also documented the risk of undergoing lead revision, which happened for 253 patients and which led to 16 major complications, a 6% rate. Fifteen of the 16 major complications occurred without lead extraction taking place. Also, the major complications occurred at roughly similar rates in patients with 7F or 8F leads.

Dr. Parkash also highlighted that cable externalization often occurs late after implantation, and so additional cases are still possible. “We may just be seeing the cusp of lead failure” in the data collected so far, she suggested.

One concern the new data did not stoke is the risk for lead shorting that produces sudden ICD failure. “I think [shorting] is not as much of a problem as we previously thought,” Dr. Parkash said.

“These data give credence to the strategy of keeping the Riata leads in place, and, if you are concerned about their function, capping them and putting in a new lead,” commented Dr. Fred M. Kusumoto, an electrophysiologist and professor of medicine at the Mayo Clinic, Florida in Jacksonville. In addition, the new data demonstrate that the problem is in both the 7F as well as the 8F leads. “The entire Riata design was not very good,” he said in an interview. But a reassuring result in the Canadian registry was the low rate of shorting, or high-voltage failure of the lead, Dr. Kusumoto said.

[email protected]

On Twitter @mitchelzoler

BOSTON – The problem-plagued St. Jude Riata leads for implantable cardioverter defibrillators, pulled from the U.S. market in 2010, continue to pose problems for the tens of thousands of patients who still have them as clinicians follow these patients out to periods approaching 10 years.

But the risks of lead extraction continue make prophylactic lead removal a poor option for most patients, leaving the alternative of continuing to closely monitor patients for episodes of electrical lead failure, Dr. Ratika Parkash said at the annual scientific sessions of the Heart Rhythm Society.

Mitchel L. Zoler/Frontline Medical News

“Isolated, prophylactic lead revision or extraction is not warranted,” said Dr. Parkash, a cardiac electrophysiologist at Dalhousie University in Halifax, Canada. “We need to take into account a patient’s comorbidities compared with the possibility of cable externalization,” when the conducting cable of the lead moves outside its insulating sheath, one of the main problems with the St. Jude Riata leads, she explained. “I think we need to individualize what we do” based on each patient’s specific situation, but perhaps collecting more data during another 2 years follow-up might shed more light on this issue, she said. Dr. Parkash and her associates followed Riata-lead recipients for an average of 7.5 years to produce the current report.

Although no U.S. patient has received a Riata lead for nearly 5 years, the Food and Drug Administration estimated that at the time St. Jude stopped selling this lead in late 2010 more than 227,000 Riata leads had gone into patients worldwide, including about 79,000 U.S. patients. Last February, St. Jude announced that it had settled 950 lawsuits or claims from U.S. patients who had received Riata leads.

The CREDO (Canadian Registry of Cardiac Implantable Electronic Device Outcomes) prospective registry review reported by Dr. Parkash included data from 2,707 patients who received Riata leads at any of 15 Canadian centers, representing 60% of the 4,538 Canadian residents who had received on of these leads. The patients averaged 63 years of age, 19% were women, 70% had received an 8 French lead and 30% had received a 7F lead, and follow-up data were available for an average of 7.5 years from the time patients received the leads to attach their implantable cardioverter defibrillator (ICD) to their heart.

Mitchel L. Zoler/Frontline Medical News

During follow-up, 378 of the 2,707 patients (14%) required revision of their leads, a rate well above the rates seen collectively for all ICD lead models in data collected in both randomized trials and in the U.S. national registry of ICD implantations maintained by the National Cardiovascular Data Registry (OpenHeart 2015;2: [doi:10.1136/openhrt-2014-000198]). The rate of lead revisions seen with the Riata lead, 14% during 7.5 years follow-up, puts it in the ballpark of the 17% lead-failure rate with 5 year follow-up seen in Canadian patients who received a Sprint Fidelis lead that was marketed by Medtronic.(Circulation 2012:1217-25)

Triggering the 378 Riata revisions were electrical abnormalities, in 42%, lead dislodgement in 18%, cable externalization in 12%, infection in 12%, and several other types of events causing the other revisions.

The rate of electrical failures remained steady throughout follow-up, averaging about 0.8%/ year for both the 8F leads, which the researchers could follow for up to 10 years, and for the 7F leads, which they followed out to as long as 8 years. Cable externalizations occurred in 7% of the 8F leads and in 5% of the 7F leads, a difference that was not statistically significant. Fewer than half the patients, 1,187 (44%) underwent radiographic assessment of cable externalization. About 90% of all the detected cable externalizations in both the 7F and 8F leads did not produce electrical failure.

A multivariate analysis identified two factors independently linked with lead failure: patient age and left ventricular ejection fraction. Every 10 years of additional patient age linked with a 16% reduced rate of lead failure. And every 10% in additional ejection fraction linked with a 26% increased rate of lead failure.

The Canadian experience also documented the risk of undergoing lead revision, which happened for 253 patients and which led to 16 major complications, a 6% rate. Fifteen of the 16 major complications occurred without lead extraction taking place. Also, the major complications occurred at roughly similar rates in patients with 7F or 8F leads.

Dr. Parkash also highlighted that cable externalization often occurs late after implantation, and so additional cases are still possible. “We may just be seeing the cusp of lead failure” in the data collected so far, she suggested.

One concern the new data did not stoke is the risk for lead shorting that produces sudden ICD failure. “I think [shorting] is not as much of a problem as we previously thought,” Dr. Parkash said.

“These data give credence to the strategy of keeping the Riata leads in place, and, if you are concerned about their function, capping them and putting in a new lead,” commented Dr. Fred M. Kusumoto, an electrophysiologist and professor of medicine at the Mayo Clinic, Florida in Jacksonville. In addition, the new data demonstrate that the problem is in both the 7F as well as the 8F leads. “The entire Riata design was not very good,” he said in an interview. But a reassuring result in the Canadian registry was the low rate of shorting, or high-voltage failure of the lead, Dr. Kusumoto said.

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – More nurses, robust ancillary services, and an electronic medical record (EMR) helped reduce hospital length of stay when an urgent general surgery procedure was performed on the weekend. When these surgeon-independent resources were present, hospitals were able to overcome the weekend effect.

When a patient needs urgent surgery over the weekend, the result can be increased length of stay, higher charges, increased major and minor complications, and even increased mortality. Overall, patients admitted on the weekend have worse outcomes than do those admitted on a weekday. Factors contributing to the weekend effect for hospitals in one state were explored in a presentation at the American Surgical Association annual meeting.

©Stevan Ovicigor/thinkstockphotos.com

“Not all hospitals are created equal in their ability to avoid the weekend effect,” noted presenter Matthew Zapf, a second-year medical student at Stritch School of Medicine, Loyola University Chicago. The work of Mr. Zapf and his colleagues at the university showed that hospitals with full electronic medical records, increased nurse-to-bed ratios, pain and wound management services, and home health programs were more likely to overcome the weekend effect, as defined by length of stay for specific urgent and emergent surgical procedures.

The study used Florida’s Healthcare Cost and Utilization Project State Inpatient Dataset (HCUP-SID), an all-payer dataset, and linked that information to Florida’s American Hospital Association annual survey database, which assesses hospital characteristics. Outcomes were assessed for cholecystectomy, hernia repair for obstructed or gangrenous hernias, and appendectomy for 126,666 people aged 18-90 years. To ensure that the study captured just urgent or emergency procedures, only procedures performed within 2 days of hospital admission were included.

By assessing whether length of stay was longer for weekend vs. weekday admissions for these procedures, the researchers identified which hospitals demonstrated the weekend effect. Of the 197 acute care hospitals identified, 117 performed more than 10 emergent cases per year and were included in the analysis. The presence or absence of a weekend effect was recorded for each hospital for each year of the study. Hospital characteristics were assessed for association with the weekend effect for a given facility in a given year.

None of the 117 hospitals were free of the weekend effect – an outcome that had not been anticipated by the study authors. “I was shocked by the fact that nobody was immune to the weekend effect,” Dr. Anai Kothari said in an interview. Dr. Kothari, also of Loyola University Chicago and first author of the study, said that 41 of the hospitals had a persistent weekend effect through all years of the study. Seventeen hospitals overcame the weekend effect during the time period studied, while 21 others developed the weekend effect during this time. Most hospitals (n = 87) oscillated between states, exhibiting a weekend effect only in some years.

Institutions with an EMR in place during the study period had an odds ratio (OR) of nearly 5 of being able to overcome the weekend effect (P = .010). The EMR, said Dr. Kothari, is especially helpful in effecting safe care transitions. “We are going to see a strong effect, especially in situations where there’s a care transition” as institutions learn how to make full use of the EMR, he said.

Inpatient resources linked with overcoming the weekend effect included a higher ratio of registered nurses to beds (P = .0036), a physical rehabilitation program (P = .017), and a pain management program (P = .001). After-care resources in the form of home health (P = .001) and wound management (P = .043) also contributed significantly to being able to overcome the weekend effect.

Discussant Dr. Lena Napolitano of the University of Michigan commented on the “incredibly robust statistical analysis” performed by the study investigators.

How, she asked, did investigators select median length of stay as the marker for outcomes, when an extended stay over the weekend may just represent poor discharge planning, and not really represent increased adverse outcomes? Senior author Dr. Paul Kuo of Loyola University Chicago replied: “We put a lot of thought into this. We found that length of stay was predictive of each outcome during modeling.”

Study limitations included the fact that data were administrative and were drawn from a single state. It was not possible, for example, to differentiate weekend vs. weekday distribution of resources at a given institution. The next steps will include searching for richer data sources to explore the full set of hospital resources that contribute to patient outcomes for urgent surgeries, said Dr. Kothari.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – More nurses, robust ancillary services, and an electronic medical record (EMR) helped reduce hospital length of stay when an urgent general surgery procedure was performed on the weekend. When these surgeon-independent resources were present, hospitals were able to overcome the weekend effect.

When a patient needs urgent surgery over the weekend, the result can be increased length of stay, higher charges, increased major and minor complications, and even increased mortality. Overall, patients admitted on the weekend have worse outcomes than do those admitted on a weekday. Factors contributing to the weekend effect for hospitals in one state were explored in a presentation at the American Surgical Association annual meeting.

©Stevan Ovicigor/thinkstockphotos.com

“Not all hospitals are created equal in their ability to avoid the weekend effect,” noted presenter Matthew Zapf, a second-year medical student at Stritch School of Medicine, Loyola University Chicago. The work of Mr. Zapf and his colleagues at the university showed that hospitals with full electronic medical records, increased nurse-to-bed ratios, pain and wound management services, and home health programs were more likely to overcome the weekend effect, as defined by length of stay for specific urgent and emergent surgical procedures.

The study used Florida’s Healthcare Cost and Utilization Project State Inpatient Dataset (HCUP-SID), an all-payer dataset, and linked that information to Florida’s American Hospital Association annual survey database, which assesses hospital characteristics. Outcomes were assessed for cholecystectomy, hernia repair for obstructed or gangrenous hernias, and appendectomy for 126,666 people aged 18-90 years. To ensure that the study captured just urgent or emergency procedures, only procedures performed within 2 days of hospital admission were included.

By assessing whether length of stay was longer for weekend vs. weekday admissions for these procedures, the researchers identified which hospitals demonstrated the weekend effect. Of the 197 acute care hospitals identified, 117 performed more than 10 emergent cases per year and were included in the analysis. The presence or absence of a weekend effect was recorded for each hospital for each year of the study. Hospital characteristics were assessed for association with the weekend effect for a given facility in a given year.

None of the 117 hospitals were free of the weekend effect – an outcome that had not been anticipated by the study authors. “I was shocked by the fact that nobody was immune to the weekend effect,” Dr. Anai Kothari said in an interview. Dr. Kothari, also of Loyola University Chicago and first author of the study, said that 41 of the hospitals had a persistent weekend effect through all years of the study. Seventeen hospitals overcame the weekend effect during the time period studied, while 21 others developed the weekend effect during this time. Most hospitals (n = 87) oscillated between states, exhibiting a weekend effect only in some years.

Institutions with an EMR in place during the study period had an odds ratio (OR) of nearly 5 of being able to overcome the weekend effect (P = .010). The EMR, said Dr. Kothari, is especially helpful in effecting safe care transitions. “We are going to see a strong effect, especially in situations where there’s a care transition” as institutions learn how to make full use of the EMR, he said.

Inpatient resources linked with overcoming the weekend effect included a higher ratio of registered nurses to beds (P = .0036), a physical rehabilitation program (P = .017), and a pain management program (P = .001). After-care resources in the form of home health (P = .001) and wound management (P = .043) also contributed significantly to being able to overcome the weekend effect.

Discussant Dr. Lena Napolitano of the University of Michigan commented on the “incredibly robust statistical analysis” performed by the study investigators.

How, she asked, did investigators select median length of stay as the marker for outcomes, when an extended stay over the weekend may just represent poor discharge planning, and not really represent increased adverse outcomes? Senior author Dr. Paul Kuo of Loyola University Chicago replied: “We put a lot of thought into this. We found that length of stay was predictive of each outcome during modeling.”

Study limitations included the fact that data were administrative and were drawn from a single state. It was not possible, for example, to differentiate weekend vs. weekday distribution of resources at a given institution. The next steps will include searching for richer data sources to explore the full set of hospital resources that contribute to patient outcomes for urgent surgeries, said Dr. Kothari.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – More nurses, robust ancillary services, and an electronic medical record (EMR) helped reduce hospital length of stay when an urgent general surgery procedure was performed on the weekend. When these surgeon-independent resources were present, hospitals were able to overcome the weekend effect.

When a patient needs urgent surgery over the weekend, the result can be increased length of stay, higher charges, increased major and minor complications, and even increased mortality. Overall, patients admitted on the weekend have worse outcomes than do those admitted on a weekday. Factors contributing to the weekend effect for hospitals in one state were explored in a presentation at the American Surgical Association annual meeting.

©Stevan Ovicigor/thinkstockphotos.com

“Not all hospitals are created equal in their ability to avoid the weekend effect,” noted presenter Matthew Zapf, a second-year medical student at Stritch School of Medicine, Loyola University Chicago. The work of Mr. Zapf and his colleagues at the university showed that hospitals with full electronic medical records, increased nurse-to-bed ratios, pain and wound management services, and home health programs were more likely to overcome the weekend effect, as defined by length of stay for specific urgent and emergent surgical procedures.

The study used Florida’s Healthcare Cost and Utilization Project State Inpatient Dataset (HCUP-SID), an all-payer dataset, and linked that information to Florida’s American Hospital Association annual survey database, which assesses hospital characteristics. Outcomes were assessed for cholecystectomy, hernia repair for obstructed or gangrenous hernias, and appendectomy for 126,666 people aged 18-90 years. To ensure that the study captured just urgent or emergency procedures, only procedures performed within 2 days of hospital admission were included.

By assessing whether length of stay was longer for weekend vs. weekday admissions for these procedures, the researchers identified which hospitals demonstrated the weekend effect. Of the 197 acute care hospitals identified, 117 performed more than 10 emergent cases per year and were included in the analysis. The presence or absence of a weekend effect was recorded for each hospital for each year of the study. Hospital characteristics were assessed for association with the weekend effect for a given facility in a given year.

None of the 117 hospitals were free of the weekend effect – an outcome that had not been anticipated by the study authors. “I was shocked by the fact that nobody was immune to the weekend effect,” Dr. Anai Kothari said in an interview. Dr. Kothari, also of Loyola University Chicago and first author of the study, said that 41 of the hospitals had a persistent weekend effect through all years of the study. Seventeen hospitals overcame the weekend effect during the time period studied, while 21 others developed the weekend effect during this time. Most hospitals (n = 87) oscillated between states, exhibiting a weekend effect only in some years.

Institutions with an EMR in place during the study period had an odds ratio (OR) of nearly 5 of being able to overcome the weekend effect (P = .010). The EMR, said Dr. Kothari, is especially helpful in effecting safe care transitions. “We are going to see a strong effect, especially in situations where there’s a care transition” as institutions learn how to make full use of the EMR, he said.

Inpatient resources linked with overcoming the weekend effect included a higher ratio of registered nurses to beds (P = .0036), a physical rehabilitation program (P = .017), and a pain management program (P = .001). After-care resources in the form of home health (P = .001) and wound management (P = .043) also contributed significantly to being able to overcome the weekend effect.

Discussant Dr. Lena Napolitano of the University of Michigan commented on the “incredibly robust statistical analysis” performed by the study investigators.

How, she asked, did investigators select median length of stay as the marker for outcomes, when an extended stay over the weekend may just represent poor discharge planning, and not really represent increased adverse outcomes? Senior author Dr. Paul Kuo of Loyola University Chicago replied: “We put a lot of thought into this. We found that length of stay was predictive of each outcome during modeling.”

Study limitations included the fact that data were administrative and were drawn from a single state. It was not possible, for example, to differentiate weekend vs. weekday distribution of resources at a given institution. The next steps will include searching for richer data sources to explore the full set of hospital resources that contribute to patient outcomes for urgent surgeries, said Dr. Kothari.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

Men who have sex with men, and women who have sexual relations with them, will be permitted to donate blood if a year has elapsed between the last such sexual encounter and the time of donation, the Food and Drug Administration has recommended.

The agency’s draft guidance follows that of the federal Advisory Committee on Blood and Tissue Safety and Availability. In November 2014, the group voted 16-2 to support a 1-year deferral policy for these populations. Any deferral decision made at a donor site would be based on donor self-identification and self-report, the draft guidance noted. Clinicians should “use their own discretion” with regard to deferring a donation from a person who self-identifies as transgender.

The document would supplant prior guidance, issued in 1985, which recommended permanent deferral for men who have sex with men (MSM) and women who had sex with them.

Should it be adopted, the new policy “will better align the deferral period with that of other men and women at increased risk for HIV infection,” then FDA Commissioner Dr. Margaret A. Hamburg said in a press statement last December. Safety and blood surveillance measures already in place will be enough to detect any HIV-contaminated blood that might enter the donor pool, she said.

The national blood surveillance system will help the agency monitor the effect of any policy change and further ensure the continued safety of the blood supply. This, along with a donor education program, has reduced the risk of an HIV infection from donated blood to about 1/1.47 million transfusions, according to the draft document.

The proposal was based on the committee’s evidence review, during which data from a similar change in deferral status in Australia weighed in favor of the recommendations. During the 5 years before and after a change from lifetime deferral to the 1-year deferral for MSM, there was no change in the risk of HIV-contaminated blood entering the donor pool or the proportion of HIV-positive donors.

Despite being “a step in the right direction,” the proposed 1-year deferral still discriminates against MSM, according to David Stacy, government affairs director for the Human Rights Campaign, the nation’s largest lesbian, gay, bisexual, and transgender civil rights organization.

“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” he said in a press statement. “It simply cannot be justified in light of current scientific research and updated blood screening technology.”

The draft guidance is not binding. It will be published on the Federal Register, which at that time will announce the deadline for comment.

[email protected]

On Twitter @alz_gal

Men who have sex with men, and women who have sexual relations with them, will be permitted to donate blood if a year has elapsed between the last such sexual encounter and the time of donation, the Food and Drug Administration has recommended.

The agency’s draft guidance follows that of the federal Advisory Committee on Blood and Tissue Safety and Availability. In November 2014, the group voted 16-2 to support a 1-year deferral policy for these populations. Any deferral decision made at a donor site would be based on donor self-identification and self-report, the draft guidance noted. Clinicians should “use their own discretion” with regard to deferring a donation from a person who self-identifies as transgender.

The document would supplant prior guidance, issued in 1985, which recommended permanent deferral for men who have sex with men (MSM) and women who had sex with them.

Should it be adopted, the new policy “will better align the deferral period with that of other men and women at increased risk for HIV infection,” then FDA Commissioner Dr. Margaret A. Hamburg said in a press statement last December. Safety and blood surveillance measures already in place will be enough to detect any HIV-contaminated blood that might enter the donor pool, she said.

The national blood surveillance system will help the agency monitor the effect of any policy change and further ensure the continued safety of the blood supply. This, along with a donor education program, has reduced the risk of an HIV infection from donated blood to about 1/1.47 million transfusions, according to the draft document.

The proposal was based on the committee’s evidence review, during which data from a similar change in deferral status in Australia weighed in favor of the recommendations. During the 5 years before and after a change from lifetime deferral to the 1-year deferral for MSM, there was no change in the risk of HIV-contaminated blood entering the donor pool or the proportion of HIV-positive donors.

Despite being “a step in the right direction,” the proposed 1-year deferral still discriminates against MSM, according to David Stacy, government affairs director for the Human Rights Campaign, the nation’s largest lesbian, gay, bisexual, and transgender civil rights organization.

“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” he said in a press statement. “It simply cannot be justified in light of current scientific research and updated blood screening technology.”

The draft guidance is not binding. It will be published on the Federal Register, which at that time will announce the deadline for comment.

[email protected]

On Twitter @alz_gal

Men who have sex with men, and women who have sexual relations with them, will be permitted to donate blood if a year has elapsed between the last such sexual encounter and the time of donation, the Food and Drug Administration has recommended.

The agency’s draft guidance follows that of the federal Advisory Committee on Blood and Tissue Safety and Availability. In November 2014, the group voted 16-2 to support a 1-year deferral policy for these populations. Any deferral decision made at a donor site would be based on donor self-identification and self-report, the draft guidance noted. Clinicians should “use their own discretion” with regard to deferring a donation from a person who self-identifies as transgender.

The document would supplant prior guidance, issued in 1985, which recommended permanent deferral for men who have sex with men (MSM) and women who had sex with them.

Should it be adopted, the new policy “will better align the deferral period with that of other men and women at increased risk for HIV infection,” then FDA Commissioner Dr. Margaret A. Hamburg said in a press statement last December. Safety and blood surveillance measures already in place will be enough to detect any HIV-contaminated blood that might enter the donor pool, she said.

The national blood surveillance system will help the agency monitor the effect of any policy change and further ensure the continued safety of the blood supply. This, along with a donor education program, has reduced the risk of an HIV infection from donated blood to about 1/1.47 million transfusions, according to the draft document.

The proposal was based on the committee’s evidence review, during which data from a similar change in deferral status in Australia weighed in favor of the recommendations. During the 5 years before and after a change from lifetime deferral to the 1-year deferral for MSM, there was no change in the risk of HIV-contaminated blood entering the donor pool or the proportion of HIV-positive donors.

Despite being “a step in the right direction,” the proposed 1-year deferral still discriminates against MSM, according to David Stacy, government affairs director for the Human Rights Campaign, the nation’s largest lesbian, gay, bisexual, and transgender civil rights organization.

“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” he said in a press statement. “It simply cannot be justified in light of current scientific research and updated blood screening technology.”

The draft guidance is not binding. It will be published on the Federal Register, which at that time will announce the deadline for comment.

[email protected]

On Twitter @alz_gal