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Direct oral anticoagulants okay during AF device placement
ANAHEIM, CALIF. – Whether direct oral anticoagulants are continued or interrupted for device placement in atrial fibrillation patients, the risk of device pocket hematoma or stroke is very low, based on results of the BRUISE CONTROL–2 trial in more than 600 subjects.
Either strategy is reasonable depending on the clinical scenario, coprincipal investigator David Birnie, MD, said in presenting the results at the American Heart Association scientific sessions.
When atrial fibrillation (AF) patients on direct oral anticoagulants (DOACs) present for device surgery, there’s concern that keeping them on the drugs will increase the bleeding risk, but that taking them off will increase the stroke risk. “We sought to resolve this dilemma,” said Dr. Birnie, an electrophysiologist and director of the arrhythmia service at the University of Ottawa Heart Institute.
The subjects were on dabigatran, rivaroxaban, or apixaban, about a third in each group; 328 were randomized to continue their daily dosing, including on the day of surgery. The other 334 were randomized to interrupted treatment. For rivaroxaban and apixaban, that meant taking their last dose 2 days before surgery. Dabigatran patients discontinued the drug 1-2 days beforehand, depending on glomerular filtration rate. Patients resumed treatment about 24 hours after surgery. CHA2DS2-VASc scores were a mean of 3.9 in both arms, and at least 2 in all participants.
The rate of clinically significant hematoma – the primary outcome in the study, defined as a hematoma requiring prolonged hospitalization, interrupted postoperative anticoagulation, or reoperation to evacuate – was identical in both arms, 2.1% (seven patients each). There were two ischemic strokes, one in each arm. There was one delayed cardiac tamponade in the continuation arm and one pericardial effusion in the interrupted arm. The three deaths in the trial were not related to device placement.
So, what to do depends on the clinical scenario, Dr. Birnie said in an interview. If someone needs urgent placement and there’s no time to wait for DOAC washout, “it’s quite reasonable to go ahead.” Also, “if somebody is at extremely high risk for stroke, then it’s very reasonable to continue the drug.”
On the other hand, “if someone has a much lower stroke risk, then the risk-benefit ratio is probably in the opposite direction, so temporarily discontinuing the drug is the right thing to do,” he said.
Dr. Birnie cautioned that although continued DOAC may reduce the risk of thromboembolism, “this study was not designed with power to answer this.”
“We are already putting these findings into practice” in Ottawa, he said. “Our protocol” – as in many places – “ was always to stop anticoagulation for 2 or 3 days, but now, for very high-risk patients – high-risk AF, unstable temporary pacing, that type of thing – we are very comfortable continuing it,” he said. The study follows up a previous randomized trial by Dr. Birnie and his colleagues that pitted continued warfarin against heparin bridging for AF device placement. There were far fewer device pocket hematomas with uninterrupted warfarin (N Engl J Med. 2013 May 30;368[22]:2084-93).
The team wanted to repeat the study using DOACs, since their use has grown substantially, with the majority of AF patients now on them.
The arms in BRUISE CONTROL–2 (Strategy of Continued Versus Interrupted Novel Oral Anticoagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events) were well matched, with a mean age of about 74 years; men made up more than 70% of the subjects in both arms. About 17% of the participants were on chronic aspirin therapy and about 4% were on clopidogrel, in each arm. The uninterrupted DOAC group went about 14 hours between their last preop and first postop DOAC dose. The interrupted group went about 72 hours.
BRUISE CONTROL–2 was funded by the Heart and Stroke Foundation of Canada, Boehringer Ingelheim, Bayer, Pfizer, and Bristol-Myers Squibb, among others. Dr. Birnie had no relevant financial disclosures.
ANAHEIM, CALIF. – Whether direct oral anticoagulants are continued or interrupted for device placement in atrial fibrillation patients, the risk of device pocket hematoma or stroke is very low, based on results of the BRUISE CONTROL–2 trial in more than 600 subjects.
Either strategy is reasonable depending on the clinical scenario, coprincipal investigator David Birnie, MD, said in presenting the results at the American Heart Association scientific sessions.
When atrial fibrillation (AF) patients on direct oral anticoagulants (DOACs) present for device surgery, there’s concern that keeping them on the drugs will increase the bleeding risk, but that taking them off will increase the stroke risk. “We sought to resolve this dilemma,” said Dr. Birnie, an electrophysiologist and director of the arrhythmia service at the University of Ottawa Heart Institute.
The subjects were on dabigatran, rivaroxaban, or apixaban, about a third in each group; 328 were randomized to continue their daily dosing, including on the day of surgery. The other 334 were randomized to interrupted treatment. For rivaroxaban and apixaban, that meant taking their last dose 2 days before surgery. Dabigatran patients discontinued the drug 1-2 days beforehand, depending on glomerular filtration rate. Patients resumed treatment about 24 hours after surgery. CHA2DS2-VASc scores were a mean of 3.9 in both arms, and at least 2 in all participants.
The rate of clinically significant hematoma – the primary outcome in the study, defined as a hematoma requiring prolonged hospitalization, interrupted postoperative anticoagulation, or reoperation to evacuate – was identical in both arms, 2.1% (seven patients each). There were two ischemic strokes, one in each arm. There was one delayed cardiac tamponade in the continuation arm and one pericardial effusion in the interrupted arm. The three deaths in the trial were not related to device placement.
So, what to do depends on the clinical scenario, Dr. Birnie said in an interview. If someone needs urgent placement and there’s no time to wait for DOAC washout, “it’s quite reasonable to go ahead.” Also, “if somebody is at extremely high risk for stroke, then it’s very reasonable to continue the drug.”
On the other hand, “if someone has a much lower stroke risk, then the risk-benefit ratio is probably in the opposite direction, so temporarily discontinuing the drug is the right thing to do,” he said.
Dr. Birnie cautioned that although continued DOAC may reduce the risk of thromboembolism, “this study was not designed with power to answer this.”
“We are already putting these findings into practice” in Ottawa, he said. “Our protocol” – as in many places – “ was always to stop anticoagulation for 2 or 3 days, but now, for very high-risk patients – high-risk AF, unstable temporary pacing, that type of thing – we are very comfortable continuing it,” he said. The study follows up a previous randomized trial by Dr. Birnie and his colleagues that pitted continued warfarin against heparin bridging for AF device placement. There were far fewer device pocket hematomas with uninterrupted warfarin (N Engl J Med. 2013 May 30;368[22]:2084-93).
The team wanted to repeat the study using DOACs, since their use has grown substantially, with the majority of AF patients now on them.
The arms in BRUISE CONTROL–2 (Strategy of Continued Versus Interrupted Novel Oral Anticoagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events) were well matched, with a mean age of about 74 years; men made up more than 70% of the subjects in both arms. About 17% of the participants were on chronic aspirin therapy and about 4% were on clopidogrel, in each arm. The uninterrupted DOAC group went about 14 hours between their last preop and first postop DOAC dose. The interrupted group went about 72 hours.
BRUISE CONTROL–2 was funded by the Heart and Stroke Foundation of Canada, Boehringer Ingelheim, Bayer, Pfizer, and Bristol-Myers Squibb, among others. Dr. Birnie had no relevant financial disclosures.
ANAHEIM, CALIF. – Whether direct oral anticoagulants are continued or interrupted for device placement in atrial fibrillation patients, the risk of device pocket hematoma or stroke is very low, based on results of the BRUISE CONTROL–2 trial in more than 600 subjects.
Either strategy is reasonable depending on the clinical scenario, coprincipal investigator David Birnie, MD, said in presenting the results at the American Heart Association scientific sessions.
When atrial fibrillation (AF) patients on direct oral anticoagulants (DOACs) present for device surgery, there’s concern that keeping them on the drugs will increase the bleeding risk, but that taking them off will increase the stroke risk. “We sought to resolve this dilemma,” said Dr. Birnie, an electrophysiologist and director of the arrhythmia service at the University of Ottawa Heart Institute.
The subjects were on dabigatran, rivaroxaban, or apixaban, about a third in each group; 328 were randomized to continue their daily dosing, including on the day of surgery. The other 334 were randomized to interrupted treatment. For rivaroxaban and apixaban, that meant taking their last dose 2 days before surgery. Dabigatran patients discontinued the drug 1-2 days beforehand, depending on glomerular filtration rate. Patients resumed treatment about 24 hours after surgery. CHA2DS2-VASc scores were a mean of 3.9 in both arms, and at least 2 in all participants.
The rate of clinically significant hematoma – the primary outcome in the study, defined as a hematoma requiring prolonged hospitalization, interrupted postoperative anticoagulation, or reoperation to evacuate – was identical in both arms, 2.1% (seven patients each). There were two ischemic strokes, one in each arm. There was one delayed cardiac tamponade in the continuation arm and one pericardial effusion in the interrupted arm. The three deaths in the trial were not related to device placement.
So, what to do depends on the clinical scenario, Dr. Birnie said in an interview. If someone needs urgent placement and there’s no time to wait for DOAC washout, “it’s quite reasonable to go ahead.” Also, “if somebody is at extremely high risk for stroke, then it’s very reasonable to continue the drug.”
On the other hand, “if someone has a much lower stroke risk, then the risk-benefit ratio is probably in the opposite direction, so temporarily discontinuing the drug is the right thing to do,” he said.
Dr. Birnie cautioned that although continued DOAC may reduce the risk of thromboembolism, “this study was not designed with power to answer this.”
“We are already putting these findings into practice” in Ottawa, he said. “Our protocol” – as in many places – “ was always to stop anticoagulation for 2 or 3 days, but now, for very high-risk patients – high-risk AF, unstable temporary pacing, that type of thing – we are very comfortable continuing it,” he said. The study follows up a previous randomized trial by Dr. Birnie and his colleagues that pitted continued warfarin against heparin bridging for AF device placement. There were far fewer device pocket hematomas with uninterrupted warfarin (N Engl J Med. 2013 May 30;368[22]:2084-93).
The team wanted to repeat the study using DOACs, since their use has grown substantially, with the majority of AF patients now on them.
The arms in BRUISE CONTROL–2 (Strategy of Continued Versus Interrupted Novel Oral Anticoagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events) were well matched, with a mean age of about 74 years; men made up more than 70% of the subjects in both arms. About 17% of the participants were on chronic aspirin therapy and about 4% were on clopidogrel, in each arm. The uninterrupted DOAC group went about 14 hours between their last preop and first postop DOAC dose. The interrupted group went about 72 hours.
BRUISE CONTROL–2 was funded by the Heart and Stroke Foundation of Canada, Boehringer Ingelheim, Bayer, Pfizer, and Bristol-Myers Squibb, among others. Dr. Birnie had no relevant financial disclosures.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: The rate of clinically significant hematoma was identical in both arms, at 2.1% (seven patients each).
Data source: BRUISE CONTROL-2, a randomized trial with more than 600 subjects.
Disclosures: The work was funded by the Heart and Stroke Foundation of Canada, Boehringer Ingelheim, Bayer, Pfizer, and Bristol-Myers Squibb, among others. The presenter had no relevant financial disclosures.
DAPT produces better CABG outcomes than aspirin alone
ANAHEIM, CALIF. – Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.
After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.
“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.
The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.
“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.
DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.
[email protected]
On Twitter @mitchelzoler
Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.
But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.
The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .
Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.
But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.
The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .
Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.
But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.
The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .
ANAHEIM, CALIF. – Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.
After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.
“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.
The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.
“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.
DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.
After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.
“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.
The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.
“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.
DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: The 1-year saphenous-vein graft patency rate was 89% with DAPT treatment and 77% with aspirin alone. Data source: DACAB, a multicenter, randomized trial with 500 Chinese patients.
Disclosures: DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi.
Heart surgery halves in-hospital mortality in trisomy 13 and 18
For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.
In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).
The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.
Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.
For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).
This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.
These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.
Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.
Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”
The article by Kosiv and colleagues provides “compelling evidence that congenital heart surgery can be considered” in infants with trisomy 13 or 18, according Kathy J. Jenkins, MD, MPH, and Amy E. Roberts, MD in their accompanying editorial. The decision, however, should be made as part of a comprehensive treatment plan, they said.
“In our view, this should only occur when parents are fully informed of the still significant residual infant mortality risk with cardiac surgery … and unavoidable, severe neurocognitive delays,” they wrote in their editorial.
Caregivers helping families make the decision, they added, should be aware that delays in decision-making might make operations impossible or even more risky than they already are.
“The revolution in congenital heart surgery … has now changed the equation for infants with trisomy 18 and 13 just as it did for trisomy 21 in the past,” the authors wrote. “However, numerous factors must be taken into account to optimize decision-making for each infant and family.”
Dr. Jenkins, MD, MPH, and Dr. Roberts, MD are with the Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts. These comments are based on their editorial (Pediatrics 2017. doi: https://doi.org/10.1542/peds.2017-2809). The authors reported no potential conflicts of interest.
The article by Kosiv and colleagues provides “compelling evidence that congenital heart surgery can be considered” in infants with trisomy 13 or 18, according Kathy J. Jenkins, MD, MPH, and Amy E. Roberts, MD in their accompanying editorial. The decision, however, should be made as part of a comprehensive treatment plan, they said.
“In our view, this should only occur when parents are fully informed of the still significant residual infant mortality risk with cardiac surgery … and unavoidable, severe neurocognitive delays,” they wrote in their editorial.
Caregivers helping families make the decision, they added, should be aware that delays in decision-making might make operations impossible or even more risky than they already are.
“The revolution in congenital heart surgery … has now changed the equation for infants with trisomy 18 and 13 just as it did for trisomy 21 in the past,” the authors wrote. “However, numerous factors must be taken into account to optimize decision-making for each infant and family.”
Dr. Jenkins, MD, MPH, and Dr. Roberts, MD are with the Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts. These comments are based on their editorial (Pediatrics 2017. doi: https://doi.org/10.1542/peds.2017-2809). The authors reported no potential conflicts of interest.
The article by Kosiv and colleagues provides “compelling evidence that congenital heart surgery can be considered” in infants with trisomy 13 or 18, according Kathy J. Jenkins, MD, MPH, and Amy E. Roberts, MD in their accompanying editorial. The decision, however, should be made as part of a comprehensive treatment plan, they said.
“In our view, this should only occur when parents are fully informed of the still significant residual infant mortality risk with cardiac surgery … and unavoidable, severe neurocognitive delays,” they wrote in their editorial.
Caregivers helping families make the decision, they added, should be aware that delays in decision-making might make operations impossible or even more risky than they already are.
“The revolution in congenital heart surgery … has now changed the equation for infants with trisomy 18 and 13 just as it did for trisomy 21 in the past,” the authors wrote. “However, numerous factors must be taken into account to optimize decision-making for each infant and family.”
Dr. Jenkins, MD, MPH, and Dr. Roberts, MD are with the Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts. These comments are based on their editorial (Pediatrics 2017. doi: https://doi.org/10.1542/peds.2017-2809). The authors reported no potential conflicts of interest.
For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.
In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).
The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.
Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.
For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).
This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.
These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.
Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.
Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”
For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.
In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).
The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.
Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.
For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).
This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.
These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.
Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.
Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”
FROM PEDIATRICS
Key clinical point: Despite many centers choosing not to perform congenital heart surgery in infants with trisomy 13 and trisomy 18, doing so cuts in-hospital mortality by more than half.
Major finding: In-hospital mortality was 45% lower in trisomy 13 patients (P = 0.003) and 64% lower in trisomy 18 patients (P < 0.001) who underwent surgery.
Data source: A large, retrospective, multicenter cohort study of 1,668 newborns with trisomy 13 or 18 admitted within 14 days of birth.
Disclosures: The authors reported no potential conflicts of interest.
Why VADS is gaining ground in pediatrics
The miniaturization of continuous-flow ventricular assist devices has launched the era of continuous-flow VAD support in pediatric patients, and the trend may accelerate with the introduction of a continuous-flow device designed specifically for small children. In an expert opinion in the Journal of Thoracic and Cardiovascular Surgery, Iki Adachi, MD, of Baylor College of Medicine in Houston, said the emerging science of continuous-flow VADs in children promises to solve problems like device size mismatch, hospital-only VADs, and chronic therapy (J Thorac Cardiovasc Surg. 2017 Oct;154:1358-61). “With ongoing device miniaturization, enthusiasm has been growing among pediatric physicians for the use of continuous-flow VADs in children,” Dr. Adachi said. He noted the introduction of a continuous-flow device for small children, the Infant Jarvik 2015, “may further accelerate the trend.”
Dr. Adachi cited PediMACS reports that stated that more than half of the long-term devices now registered are continuous-flow devices, and that continuous-flow VADs comprised 62% of all durable VAD implants in the third quarter of 2016. “With the encouraging results recorded to date, the use of continuous-flow devices in the pediatric population is rapidly increasing,” he said.
Miniaturization has addressed the problem of size mismatch when using continuous-flow VAD devices in children, he said, noting that use of the Infant Jarvik device may be expanded even further to children as small at 8 kg or less. The PumpKIN trial(Pumps for Kids, Infants, and Neonates), which is evaluating the Infant Jarvik 2015 vs. the Berlin Heart EXCOR, could provide answers on the feasibility of continuous-flow VADs in small children.
“Based on experience with the chronic animal model, I believe that the Infant Jarvik device will properly fit the patients included in the trial,” he said.
Continuous-flow VAD in children also holds potential for managing these patients outside the hospital setting. “Outpatient management of children with continuous-flow VADs has been shown to be feasible,” he said, adding that the PediMACS registry has reported that only 45% of patients have been managed this way. “Nonetheless, with maturation of the pediatric field, outpatient management will become routine rather than the exception,” he said.
Greater use of continuous-flow VADs also may create opportunities to improve the status and suitability for transplantation of children with severe heart failure, he said. He gave as an example his group’s practice at Houston’s Texas Children’s Hospital, which is to deactivate patients on the transplant wait list for 3 months once they start continuous-flow VAD support. “A postoperative ‘grace period’ affords protected opportunities for both physical and psychological recovery,” he said. This timeout of sorts also affords the care team time to assess the myocardium for possible functional recovery.
In patients who are not good candidates for transplantation, durable continuous-flow VADs may provide chronic therapy, and in time, these patients may become suitable transplant candidates, said Dr. Adachi. “Bypassing such an unfavorable period for transplantation with prolonged VAD support may be a reasonable approach,” he said.
Patients with failing single-ventricle circulation also may benefit from VAD support, although the challenges facing this population are more profound than in other groups, Dr. Adachi said. VAD support for single-ventricle disease is sparse, but these patients require careful evaluation of the nature of their condition. “If systolic dysfunction is the predominant cause of circulatory failure, then VAD support for the failing systemic ventricle will likely improve hemodynamics,” said Dr. Adachi. VAD support also could help the patient move through the various stages of palliation.
“Again, the emphasis is not just on simply keeping the patient alive until a donor organ becomes available; rather, attention is refocused on overall health beyond survival, which may eventually affect transplantation candidacy and even post transplantation outcome,” Dr. Adachi concluded.
Dr. Adachi serves as a consultant and proctor for Berlin Heart and HeartWare, and as a consultant for the New England Research Institute related to the PumpKIN trial.
The miniaturization of continuous-flow ventricular assist devices has launched the era of continuous-flow VAD support in pediatric patients, and the trend may accelerate with the introduction of a continuous-flow device designed specifically for small children. In an expert opinion in the Journal of Thoracic and Cardiovascular Surgery, Iki Adachi, MD, of Baylor College of Medicine in Houston, said the emerging science of continuous-flow VADs in children promises to solve problems like device size mismatch, hospital-only VADs, and chronic therapy (J Thorac Cardiovasc Surg. 2017 Oct;154:1358-61). “With ongoing device miniaturization, enthusiasm has been growing among pediatric physicians for the use of continuous-flow VADs in children,” Dr. Adachi said. He noted the introduction of a continuous-flow device for small children, the Infant Jarvik 2015, “may further accelerate the trend.”
Dr. Adachi cited PediMACS reports that stated that more than half of the long-term devices now registered are continuous-flow devices, and that continuous-flow VADs comprised 62% of all durable VAD implants in the third quarter of 2016. “With the encouraging results recorded to date, the use of continuous-flow devices in the pediatric population is rapidly increasing,” he said.
Miniaturization has addressed the problem of size mismatch when using continuous-flow VAD devices in children, he said, noting that use of the Infant Jarvik device may be expanded even further to children as small at 8 kg or less. The PumpKIN trial(Pumps for Kids, Infants, and Neonates), which is evaluating the Infant Jarvik 2015 vs. the Berlin Heart EXCOR, could provide answers on the feasibility of continuous-flow VADs in small children.
“Based on experience with the chronic animal model, I believe that the Infant Jarvik device will properly fit the patients included in the trial,” he said.
Continuous-flow VAD in children also holds potential for managing these patients outside the hospital setting. “Outpatient management of children with continuous-flow VADs has been shown to be feasible,” he said, adding that the PediMACS registry has reported that only 45% of patients have been managed this way. “Nonetheless, with maturation of the pediatric field, outpatient management will become routine rather than the exception,” he said.
Greater use of continuous-flow VADs also may create opportunities to improve the status and suitability for transplantation of children with severe heart failure, he said. He gave as an example his group’s practice at Houston’s Texas Children’s Hospital, which is to deactivate patients on the transplant wait list for 3 months once they start continuous-flow VAD support. “A postoperative ‘grace period’ affords protected opportunities for both physical and psychological recovery,” he said. This timeout of sorts also affords the care team time to assess the myocardium for possible functional recovery.
In patients who are not good candidates for transplantation, durable continuous-flow VADs may provide chronic therapy, and in time, these patients may become suitable transplant candidates, said Dr. Adachi. “Bypassing such an unfavorable period for transplantation with prolonged VAD support may be a reasonable approach,” he said.
Patients with failing single-ventricle circulation also may benefit from VAD support, although the challenges facing this population are more profound than in other groups, Dr. Adachi said. VAD support for single-ventricle disease is sparse, but these patients require careful evaluation of the nature of their condition. “If systolic dysfunction is the predominant cause of circulatory failure, then VAD support for the failing systemic ventricle will likely improve hemodynamics,” said Dr. Adachi. VAD support also could help the patient move through the various stages of palliation.
“Again, the emphasis is not just on simply keeping the patient alive until a donor organ becomes available; rather, attention is refocused on overall health beyond survival, which may eventually affect transplantation candidacy and even post transplantation outcome,” Dr. Adachi concluded.
Dr. Adachi serves as a consultant and proctor for Berlin Heart and HeartWare, and as a consultant for the New England Research Institute related to the PumpKIN trial.
The miniaturization of continuous-flow ventricular assist devices has launched the era of continuous-flow VAD support in pediatric patients, and the trend may accelerate with the introduction of a continuous-flow device designed specifically for small children. In an expert opinion in the Journal of Thoracic and Cardiovascular Surgery, Iki Adachi, MD, of Baylor College of Medicine in Houston, said the emerging science of continuous-flow VADs in children promises to solve problems like device size mismatch, hospital-only VADs, and chronic therapy (J Thorac Cardiovasc Surg. 2017 Oct;154:1358-61). “With ongoing device miniaturization, enthusiasm has been growing among pediatric physicians for the use of continuous-flow VADs in children,” Dr. Adachi said. He noted the introduction of a continuous-flow device for small children, the Infant Jarvik 2015, “may further accelerate the trend.”
Dr. Adachi cited PediMACS reports that stated that more than half of the long-term devices now registered are continuous-flow devices, and that continuous-flow VADs comprised 62% of all durable VAD implants in the third quarter of 2016. “With the encouraging results recorded to date, the use of continuous-flow devices in the pediatric population is rapidly increasing,” he said.
Miniaturization has addressed the problem of size mismatch when using continuous-flow VAD devices in children, he said, noting that use of the Infant Jarvik device may be expanded even further to children as small at 8 kg or less. The PumpKIN trial(Pumps for Kids, Infants, and Neonates), which is evaluating the Infant Jarvik 2015 vs. the Berlin Heart EXCOR, could provide answers on the feasibility of continuous-flow VADs in small children.
“Based on experience with the chronic animal model, I believe that the Infant Jarvik device will properly fit the patients included in the trial,” he said.
Continuous-flow VAD in children also holds potential for managing these patients outside the hospital setting. “Outpatient management of children with continuous-flow VADs has been shown to be feasible,” he said, adding that the PediMACS registry has reported that only 45% of patients have been managed this way. “Nonetheless, with maturation of the pediatric field, outpatient management will become routine rather than the exception,” he said.
Greater use of continuous-flow VADs also may create opportunities to improve the status and suitability for transplantation of children with severe heart failure, he said. He gave as an example his group’s practice at Houston’s Texas Children’s Hospital, which is to deactivate patients on the transplant wait list for 3 months once they start continuous-flow VAD support. “A postoperative ‘grace period’ affords protected opportunities for both physical and psychological recovery,” he said. This timeout of sorts also affords the care team time to assess the myocardium for possible functional recovery.
In patients who are not good candidates for transplantation, durable continuous-flow VADs may provide chronic therapy, and in time, these patients may become suitable transplant candidates, said Dr. Adachi. “Bypassing such an unfavorable period for transplantation with prolonged VAD support may be a reasonable approach,” he said.
Patients with failing single-ventricle circulation also may benefit from VAD support, although the challenges facing this population are more profound than in other groups, Dr. Adachi said. VAD support for single-ventricle disease is sparse, but these patients require careful evaluation of the nature of their condition. “If systolic dysfunction is the predominant cause of circulatory failure, then VAD support for the failing systemic ventricle will likely improve hemodynamics,” said Dr. Adachi. VAD support also could help the patient move through the various stages of palliation.
“Again, the emphasis is not just on simply keeping the patient alive until a donor organ becomes available; rather, attention is refocused on overall health beyond survival, which may eventually affect transplantation candidacy and even post transplantation outcome,” Dr. Adachi concluded.
Dr. Adachi serves as a consultant and proctor for Berlin Heart and HeartWare, and as a consultant for the New England Research Institute related to the PumpKIN trial.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Advances in continuous-flow ventricular assist devices (VADs) promise a paradigm shift in pediatrics.
Major finding: Device miniaturization is solving problems such as size mismatch, inpatients on VADs, and chronic therapy.
Data source: Expert opinion drawing on PediMACS reports and published trials of continuous-flow VAD.
Disclosures: Dr. Adachi serves as a consultant and proctor for Berlin Heart and HeartWare and as a consultant for the New England Research Institute related to the PumpKIN trial.
Challenges of validating cerebral protection for TAVI
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Cerebral embolic protection during TAVI is an appealing concept that faces challenges.
Major finding: Developing practical and safe devices and testing them in adequately powered trials are daunting tasks.
Data source: Review of five completed and two ongoing clinical trials of 603 and 613 patients, respectively.
Disclosures: Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the NIH/NHLBI/NINDS-sponsored Cardiothoracic Surgery Network.
Cold stored platelets control bleeding after complex cardiac surgery
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
AT AABB17
Key clinical point: Cold stored leukoreduced apheresis platelets in platelet additive solution are effective for treating bleeding in patients undergoing complex cardiothoracic surgery.
Major finding: Patients who underwent procedures requiring cardiopulmonary bypass circulation had a significantly lower median amount of bleeding in the postoperative period with cold stored platelets compared with standard room temperature platelets: 576 mL vs. 838 mL.
Data source: Randomized two-arm pilot trial of cardiothoracic surgery patients.
Disclosures: The authors have no relevant financial disclosures.
Hypothyroidism carries higher surgical risk not captured by calculator
VICTORIA, B.C. – Even with contemporary anesthesia and surgical techniques, patients who are overtly hypothyroid at the time of major surgery have a rockier course, suggests a retrospective cohort study of 58 patients in a poster presentation at the annual meeting of the American Thyroid Association.
Actual length of stay for hypothyroid patients was twice that predicted by a commonly used risk calculator, whereas actual and predicted stays aligned well for euthyroid patients. The hypothyroid group had more cases of postoperative atrial fibrillation, ileus, reintubation, and death, although numbers were too small for statistical comparison.
“This will have an impact on how we look at patients, especially from a hospital standpoint and management. That’s quite a bit longer stay and quite a bit more cost. And the longer you stay, the more complications you have, too, so it could be riskier for the patient as well,” said first author Raquel Villavicencio, MD, a fellow at Indiana University at the time of the study, and now a clinical endocrinologist at Community Hospital in Indianapolis.
“Although we don’t consider hypothyroidism an absolute contraindication to surgery, especially if it’s necessary surgery, certainly anybody who is having elective surgery should have it postponed, in our opinion, until they are rendered euthyroid,” she said. “More studies are needed to look at this a little bit closer.”
Explaining the study’s rationale, Dr. Villavicencio noted, “This was a question that came up maybe three or four times a year, where we would get a hypothyroid patient and had to decide whether or not to clear them for surgery.”
Previous studies conducted at large institutions, the Mayo Clinic and Massachusetts General Hospital, had conflicting findings and were done about 30 years ago, she said. Anesthesia and surgical care have improved substantially since then, leading the investigators to hypothesize that hypothyroidism would not carry higher surgical risk today.
Dr. Villavicencio and her coinvestigator, Cary Mariash, MD, used their institutional database to identify 29 adult patients with a thyroid-stimulating hormone (TSH) level of greater than 10 mcU/mL alone or with a TSH level exceeding the upper limit of normal along with a free thyroxine (T4) level of less than 0.6 ng/dL who underwent surgery during 2010-2015. They matched each patient on age, sex, and surgical procedure with a control euthyroid patient.
The mean TSH level in the hypothyroid group was 29.2 mcU/mL. The majority of patients in each group – 59% of the hypothyroid group and 62% of the euthyroid group – had an American Surgical Association class of 3, denoting that this was a fairly sick population. The groups were generally similar on rates of comorbidity, except that the euthyroid patients had a slightly higher prevalence of obstructive sleep apnea.
In both groups, the majority of procedures were laparotomy and/or bowel resection; pharyngolaryngectomy and esophagectomy/esophagoplasty; and wound or bone debridement.
Main results showed that in the hypothyroid group, hospital length of stay predicted with the American College of Surgeons National Surgical Quality Improvement Program surgical risk calculator was 6.9 days, but actual length of stay was 14.4 days (P = .0004). In contrast, in the euthyroid group, predicted length of stay was a similar at 7.1 days, and actual length of stay was statistically indistinguishable at 9.2 days (P = .1).
“Hypothyroidism is not taken into account with this calculator,” Dr. Villavicencio noted, adding that she was unaware of any surgical calculators that do.
One patient in the hypothyroid group died, compared with none in the euthyroid group. In terms of postoperative cardiac complications, two patients in the hypothyroid group experienced atrial fibrillation, and there was one case of pulseless electrical–activity arrest in each group.
The groups did not differ on incidence of hypothermia, bradycardia, hyponatremia, time to extubation, and hypotension. However, mean arterial pressure tended to be lower in the hypothyroid group (51 mm Hg) than in the euthyroid group (56 mm Hg), and the former more often needed vasopressors. Furthermore, postoperative ileus and reintubation were more common in the hypothyroid group.
“I think that there are kind of a lot of little things that add up to explain [the longer stay],” said Dr. Villavicencio, who disclosed that she had no relevant conflicts of interest.
VICTORIA, B.C. – Even with contemporary anesthesia and surgical techniques, patients who are overtly hypothyroid at the time of major surgery have a rockier course, suggests a retrospective cohort study of 58 patients in a poster presentation at the annual meeting of the American Thyroid Association.
Actual length of stay for hypothyroid patients was twice that predicted by a commonly used risk calculator, whereas actual and predicted stays aligned well for euthyroid patients. The hypothyroid group had more cases of postoperative atrial fibrillation, ileus, reintubation, and death, although numbers were too small for statistical comparison.
“This will have an impact on how we look at patients, especially from a hospital standpoint and management. That’s quite a bit longer stay and quite a bit more cost. And the longer you stay, the more complications you have, too, so it could be riskier for the patient as well,” said first author Raquel Villavicencio, MD, a fellow at Indiana University at the time of the study, and now a clinical endocrinologist at Community Hospital in Indianapolis.
“Although we don’t consider hypothyroidism an absolute contraindication to surgery, especially if it’s necessary surgery, certainly anybody who is having elective surgery should have it postponed, in our opinion, until they are rendered euthyroid,” she said. “More studies are needed to look at this a little bit closer.”
Explaining the study’s rationale, Dr. Villavicencio noted, “This was a question that came up maybe three or four times a year, where we would get a hypothyroid patient and had to decide whether or not to clear them for surgery.”
Previous studies conducted at large institutions, the Mayo Clinic and Massachusetts General Hospital, had conflicting findings and were done about 30 years ago, she said. Anesthesia and surgical care have improved substantially since then, leading the investigators to hypothesize that hypothyroidism would not carry higher surgical risk today.
Dr. Villavicencio and her coinvestigator, Cary Mariash, MD, used their institutional database to identify 29 adult patients with a thyroid-stimulating hormone (TSH) level of greater than 10 mcU/mL alone or with a TSH level exceeding the upper limit of normal along with a free thyroxine (T4) level of less than 0.6 ng/dL who underwent surgery during 2010-2015. They matched each patient on age, sex, and surgical procedure with a control euthyroid patient.
The mean TSH level in the hypothyroid group was 29.2 mcU/mL. The majority of patients in each group – 59% of the hypothyroid group and 62% of the euthyroid group – had an American Surgical Association class of 3, denoting that this was a fairly sick population. The groups were generally similar on rates of comorbidity, except that the euthyroid patients had a slightly higher prevalence of obstructive sleep apnea.
In both groups, the majority of procedures were laparotomy and/or bowel resection; pharyngolaryngectomy and esophagectomy/esophagoplasty; and wound or bone debridement.
Main results showed that in the hypothyroid group, hospital length of stay predicted with the American College of Surgeons National Surgical Quality Improvement Program surgical risk calculator was 6.9 days, but actual length of stay was 14.4 days (P = .0004). In contrast, in the euthyroid group, predicted length of stay was a similar at 7.1 days, and actual length of stay was statistically indistinguishable at 9.2 days (P = .1).
“Hypothyroidism is not taken into account with this calculator,” Dr. Villavicencio noted, adding that she was unaware of any surgical calculators that do.
One patient in the hypothyroid group died, compared with none in the euthyroid group. In terms of postoperative cardiac complications, two patients in the hypothyroid group experienced atrial fibrillation, and there was one case of pulseless electrical–activity arrest in each group.
The groups did not differ on incidence of hypothermia, bradycardia, hyponatremia, time to extubation, and hypotension. However, mean arterial pressure tended to be lower in the hypothyroid group (51 mm Hg) than in the euthyroid group (56 mm Hg), and the former more often needed vasopressors. Furthermore, postoperative ileus and reintubation were more common in the hypothyroid group.
“I think that there are kind of a lot of little things that add up to explain [the longer stay],” said Dr. Villavicencio, who disclosed that she had no relevant conflicts of interest.
VICTORIA, B.C. – Even with contemporary anesthesia and surgical techniques, patients who are overtly hypothyroid at the time of major surgery have a rockier course, suggests a retrospective cohort study of 58 patients in a poster presentation at the annual meeting of the American Thyroid Association.
Actual length of stay for hypothyroid patients was twice that predicted by a commonly used risk calculator, whereas actual and predicted stays aligned well for euthyroid patients. The hypothyroid group had more cases of postoperative atrial fibrillation, ileus, reintubation, and death, although numbers were too small for statistical comparison.
“This will have an impact on how we look at patients, especially from a hospital standpoint and management. That’s quite a bit longer stay and quite a bit more cost. And the longer you stay, the more complications you have, too, so it could be riskier for the patient as well,” said first author Raquel Villavicencio, MD, a fellow at Indiana University at the time of the study, and now a clinical endocrinologist at Community Hospital in Indianapolis.
“Although we don’t consider hypothyroidism an absolute contraindication to surgery, especially if it’s necessary surgery, certainly anybody who is having elective surgery should have it postponed, in our opinion, until they are rendered euthyroid,” she said. “More studies are needed to look at this a little bit closer.”
Explaining the study’s rationale, Dr. Villavicencio noted, “This was a question that came up maybe three or four times a year, where we would get a hypothyroid patient and had to decide whether or not to clear them for surgery.”
Previous studies conducted at large institutions, the Mayo Clinic and Massachusetts General Hospital, had conflicting findings and were done about 30 years ago, she said. Anesthesia and surgical care have improved substantially since then, leading the investigators to hypothesize that hypothyroidism would not carry higher surgical risk today.
Dr. Villavicencio and her coinvestigator, Cary Mariash, MD, used their institutional database to identify 29 adult patients with a thyroid-stimulating hormone (TSH) level of greater than 10 mcU/mL alone or with a TSH level exceeding the upper limit of normal along with a free thyroxine (T4) level of less than 0.6 ng/dL who underwent surgery during 2010-2015. They matched each patient on age, sex, and surgical procedure with a control euthyroid patient.
The mean TSH level in the hypothyroid group was 29.2 mcU/mL. The majority of patients in each group – 59% of the hypothyroid group and 62% of the euthyroid group – had an American Surgical Association class of 3, denoting that this was a fairly sick population. The groups were generally similar on rates of comorbidity, except that the euthyroid patients had a slightly higher prevalence of obstructive sleep apnea.
In both groups, the majority of procedures were laparotomy and/or bowel resection; pharyngolaryngectomy and esophagectomy/esophagoplasty; and wound or bone debridement.
Main results showed that in the hypothyroid group, hospital length of stay predicted with the American College of Surgeons National Surgical Quality Improvement Program surgical risk calculator was 6.9 days, but actual length of stay was 14.4 days (P = .0004). In contrast, in the euthyroid group, predicted length of stay was a similar at 7.1 days, and actual length of stay was statistically indistinguishable at 9.2 days (P = .1).
“Hypothyroidism is not taken into account with this calculator,” Dr. Villavicencio noted, adding that she was unaware of any surgical calculators that do.
One patient in the hypothyroid group died, compared with none in the euthyroid group. In terms of postoperative cardiac complications, two patients in the hypothyroid group experienced atrial fibrillation, and there was one case of pulseless electrical–activity arrest in each group.
The groups did not differ on incidence of hypothermia, bradycardia, hyponatremia, time to extubation, and hypotension. However, mean arterial pressure tended to be lower in the hypothyroid group (51 mm Hg) than in the euthyroid group (56 mm Hg), and the former more often needed vasopressors. Furthermore, postoperative ileus and reintubation were more common in the hypothyroid group.
“I think that there are kind of a lot of little things that add up to explain [the longer stay],” said Dr. Villavicencio, who disclosed that she had no relevant conflicts of interest.
AT ATA 2017
Key clinical point:
Major finding: Actual length of stay was significantly longer than calculator-predicted length of stay among hypothyroid patients (14.4 vs. 6.9 days, P = .0004) but not among euthyroid patients (9.2 vs. 7.1 days; P = .1).
Data source: A retrospective cohort study of 29 hypothyroid patients and 29 matched euthyroid patients undergoing major surgery.
Disclosures: Dr. Villavicencio disclosed that she had no relevant conflicts of interest.
Robotic-assisted pulmonary lobectomy effective for large tumors
Robotic-assisted pulmonary lobectomy is a safe and effective way to remove large tumors in patients with non–small cell lung cancer (NSCLC), according to the abstract of a study scheduled to be presented at the CHEST annual meeting.
The study covers a retrospective analysis of 345 NSCLC patients with tumors who underwent robotic-assisted pulmonary lobectomy performed by one surgeon from September 2010 through August 2016. The participants were grouped into the following three cohorts: patients with tumors less than 5 cm in diameter, patients with tumors from 5 to 7 cm, and patients with tumors larger than 7 cm. The researchers excluded patients with pulmonary metastases or benign lesions from the study.
Patients with smaller tumors were more likely to have simple lobectomy or lobectomy plus wedge, while patients with larger tumors were more likely to require lobectomy with chest wall resection. Increased tumor size was also associated with increased intraoperative estimated blood loss, skin-to-skin operative time, hospital length of stay, and overall conversion to open lobectomy.
There was no association found between tumor size and increased overall intraoperative or postoperative complications, or in-hospital mortality.
Nirav Patel, MD, FCCP, of the Tampa Bay Sleep Center is scheduled to present his abstract on Sunday Oct. 29th, between 2:15 and 2:30 p.m. in Convention Center – 606. Dr. Patel’s research is part of the Cardiothoracic Surgery session, running from 1:30 p.m. to 3:00 p.m. at the CHEST annual meeting.
Robotic-assisted pulmonary lobectomy is a safe and effective way to remove large tumors in patients with non–small cell lung cancer (NSCLC), according to the abstract of a study scheduled to be presented at the CHEST annual meeting.
The study covers a retrospective analysis of 345 NSCLC patients with tumors who underwent robotic-assisted pulmonary lobectomy performed by one surgeon from September 2010 through August 2016. The participants were grouped into the following three cohorts: patients with tumors less than 5 cm in diameter, patients with tumors from 5 to 7 cm, and patients with tumors larger than 7 cm. The researchers excluded patients with pulmonary metastases or benign lesions from the study.
Patients with smaller tumors were more likely to have simple lobectomy or lobectomy plus wedge, while patients with larger tumors were more likely to require lobectomy with chest wall resection. Increased tumor size was also associated with increased intraoperative estimated blood loss, skin-to-skin operative time, hospital length of stay, and overall conversion to open lobectomy.
There was no association found between tumor size and increased overall intraoperative or postoperative complications, or in-hospital mortality.
Nirav Patel, MD, FCCP, of the Tampa Bay Sleep Center is scheduled to present his abstract on Sunday Oct. 29th, between 2:15 and 2:30 p.m. in Convention Center – 606. Dr. Patel’s research is part of the Cardiothoracic Surgery session, running from 1:30 p.m. to 3:00 p.m. at the CHEST annual meeting.
Robotic-assisted pulmonary lobectomy is a safe and effective way to remove large tumors in patients with non–small cell lung cancer (NSCLC), according to the abstract of a study scheduled to be presented at the CHEST annual meeting.
The study covers a retrospective analysis of 345 NSCLC patients with tumors who underwent robotic-assisted pulmonary lobectomy performed by one surgeon from September 2010 through August 2016. The participants were grouped into the following three cohorts: patients with tumors less than 5 cm in diameter, patients with tumors from 5 to 7 cm, and patients with tumors larger than 7 cm. The researchers excluded patients with pulmonary metastases or benign lesions from the study.
Patients with smaller tumors were more likely to have simple lobectomy or lobectomy plus wedge, while patients with larger tumors were more likely to require lobectomy with chest wall resection. Increased tumor size was also associated with increased intraoperative estimated blood loss, skin-to-skin operative time, hospital length of stay, and overall conversion to open lobectomy.
There was no association found between tumor size and increased overall intraoperative or postoperative complications, or in-hospital mortality.
Nirav Patel, MD, FCCP, of the Tampa Bay Sleep Center is scheduled to present his abstract on Sunday Oct. 29th, between 2:15 and 2:30 p.m. in Convention Center – 606. Dr. Patel’s research is part of the Cardiothoracic Surgery session, running from 1:30 p.m. to 3:00 p.m. at the CHEST annual meeting.
FROM CHEST 2017
Higher stroke risk found for TAVR versus SAVR
SAN DIEGO – There was an 86% greater risk of ischemic stroke after transcatheter aortic valve replacement, compared with surgical aortic valve replacement, and a more than sixfold increased risk of hemorrhagic stroke, in a review of more than 44,000 patients in the Nationwide Readmissions Database who were followed out to a year after having one procedure or the other.
“Our data suggest an elevated risk of both ischemic and hemorrhagic stroke after TAVR [transcatheter aortic valve replacement]. I see a lot of people that have strokes after” TAVR, so “I wasn’t all that surprised that there is an increased risk, but could I have guessed it would have been so high? No.” Perhaps “we are offering it to people we shouldn’t be offering it to,” said lead investigator Laura Stein, MD, a vascular neurology fellow at Mount Sinai Hospital, New York.
The 2013 Nationwide Readmissions Database used in the study captured more than 14 million readmissions in the United States across all payers and the uninsured. “We used this database because its captures all comers” and reflects “more real-world practice,” Dr. Stein said.
There were 6,015 TAVR and 38,624 SAVR cases in 2013, and the team found consistently elevated cumulative risks of ischemic and hemorrhagic stroke after TAVR, compared with SAVR, according to a presentation at the annual meeting of the American Neurological Association.
Compared with SAVR, the hazard ratio for ischemic stroke with TAVR was 1.86 (95% confidence interval, 1.12-3.08; P = .016) and, for hemorrhagic stroke, 6.17 (95% CI, 1.97-19.33; P = .0018). Dr. Stein declined to release absolute numbers of strokes in the two groups, pending publication.
“A lot of attention is being paid to this topic because there has been a push, a lot of it by the device makers, to prove that [TAVR] outcomes are just as good as with traditional surgery, and that we should be offering [TAVR] to more people with higher risk factor profiles who might not have been offered repair otherwise. Our job is to help patients make the most informed decisions. Having another source of data like [ours]” adds to the conversation about risks and benefits, she said.
The investigators adjusted for a large number of potential confounders to make sure the comparison was as fair as possible given the limits of database reviews. Among other variables, they controlled for baseline cardiovascular risk factors, carotid artery disease, heart failure, obesity, smoking, surgical complications, mortality, and illness severity scores, as well as hospital size, teaching hospital status, and urban versus rural location.
“What we can’t know is what medications these patients were on that might have increased their bleeding or ischemia risk. Also, we were relying on coding done by other people,” Dr. Stein said.
The next step is to look at the impact of stenting and other concomitant procedures. “We were surprised by the number of people that had multiple procedures at the same time.” The ultimate goal is to develop a risk score to help patients and doctors decide between the two procedures, she said.
Meanwhile, the team found no difference in stroke risk between coronary artery bypass grafting and percutaneous coronary interventions in the 2013 database.
Three was no industry funding for the work, and Dr. Stein did not have any relevant disclosures.
SAN DIEGO – There was an 86% greater risk of ischemic stroke after transcatheter aortic valve replacement, compared with surgical aortic valve replacement, and a more than sixfold increased risk of hemorrhagic stroke, in a review of more than 44,000 patients in the Nationwide Readmissions Database who were followed out to a year after having one procedure or the other.
“Our data suggest an elevated risk of both ischemic and hemorrhagic stroke after TAVR [transcatheter aortic valve replacement]. I see a lot of people that have strokes after” TAVR, so “I wasn’t all that surprised that there is an increased risk, but could I have guessed it would have been so high? No.” Perhaps “we are offering it to people we shouldn’t be offering it to,” said lead investigator Laura Stein, MD, a vascular neurology fellow at Mount Sinai Hospital, New York.
The 2013 Nationwide Readmissions Database used in the study captured more than 14 million readmissions in the United States across all payers and the uninsured. “We used this database because its captures all comers” and reflects “more real-world practice,” Dr. Stein said.
There were 6,015 TAVR and 38,624 SAVR cases in 2013, and the team found consistently elevated cumulative risks of ischemic and hemorrhagic stroke after TAVR, compared with SAVR, according to a presentation at the annual meeting of the American Neurological Association.
Compared with SAVR, the hazard ratio for ischemic stroke with TAVR was 1.86 (95% confidence interval, 1.12-3.08; P = .016) and, for hemorrhagic stroke, 6.17 (95% CI, 1.97-19.33; P = .0018). Dr. Stein declined to release absolute numbers of strokes in the two groups, pending publication.
“A lot of attention is being paid to this topic because there has been a push, a lot of it by the device makers, to prove that [TAVR] outcomes are just as good as with traditional surgery, and that we should be offering [TAVR] to more people with higher risk factor profiles who might not have been offered repair otherwise. Our job is to help patients make the most informed decisions. Having another source of data like [ours]” adds to the conversation about risks and benefits, she said.
The investigators adjusted for a large number of potential confounders to make sure the comparison was as fair as possible given the limits of database reviews. Among other variables, they controlled for baseline cardiovascular risk factors, carotid artery disease, heart failure, obesity, smoking, surgical complications, mortality, and illness severity scores, as well as hospital size, teaching hospital status, and urban versus rural location.
“What we can’t know is what medications these patients were on that might have increased their bleeding or ischemia risk. Also, we were relying on coding done by other people,” Dr. Stein said.
The next step is to look at the impact of stenting and other concomitant procedures. “We were surprised by the number of people that had multiple procedures at the same time.” The ultimate goal is to develop a risk score to help patients and doctors decide between the two procedures, she said.
Meanwhile, the team found no difference in stroke risk between coronary artery bypass grafting and percutaneous coronary interventions in the 2013 database.
Three was no industry funding for the work, and Dr. Stein did not have any relevant disclosures.
SAN DIEGO – There was an 86% greater risk of ischemic stroke after transcatheter aortic valve replacement, compared with surgical aortic valve replacement, and a more than sixfold increased risk of hemorrhagic stroke, in a review of more than 44,000 patients in the Nationwide Readmissions Database who were followed out to a year after having one procedure or the other.
“Our data suggest an elevated risk of both ischemic and hemorrhagic stroke after TAVR [transcatheter aortic valve replacement]. I see a lot of people that have strokes after” TAVR, so “I wasn’t all that surprised that there is an increased risk, but could I have guessed it would have been so high? No.” Perhaps “we are offering it to people we shouldn’t be offering it to,” said lead investigator Laura Stein, MD, a vascular neurology fellow at Mount Sinai Hospital, New York.
The 2013 Nationwide Readmissions Database used in the study captured more than 14 million readmissions in the United States across all payers and the uninsured. “We used this database because its captures all comers” and reflects “more real-world practice,” Dr. Stein said.
There were 6,015 TAVR and 38,624 SAVR cases in 2013, and the team found consistently elevated cumulative risks of ischemic and hemorrhagic stroke after TAVR, compared with SAVR, according to a presentation at the annual meeting of the American Neurological Association.
Compared with SAVR, the hazard ratio for ischemic stroke with TAVR was 1.86 (95% confidence interval, 1.12-3.08; P = .016) and, for hemorrhagic stroke, 6.17 (95% CI, 1.97-19.33; P = .0018). Dr. Stein declined to release absolute numbers of strokes in the two groups, pending publication.
“A lot of attention is being paid to this topic because there has been a push, a lot of it by the device makers, to prove that [TAVR] outcomes are just as good as with traditional surgery, and that we should be offering [TAVR] to more people with higher risk factor profiles who might not have been offered repair otherwise. Our job is to help patients make the most informed decisions. Having another source of data like [ours]” adds to the conversation about risks and benefits, she said.
The investigators adjusted for a large number of potential confounders to make sure the comparison was as fair as possible given the limits of database reviews. Among other variables, they controlled for baseline cardiovascular risk factors, carotid artery disease, heart failure, obesity, smoking, surgical complications, mortality, and illness severity scores, as well as hospital size, teaching hospital status, and urban versus rural location.
“What we can’t know is what medications these patients were on that might have increased their bleeding or ischemia risk. Also, we were relying on coding done by other people,” Dr. Stein said.
The next step is to look at the impact of stenting and other concomitant procedures. “We were surprised by the number of people that had multiple procedures at the same time.” The ultimate goal is to develop a risk score to help patients and doctors decide between the two procedures, she said.
Meanwhile, the team found no difference in stroke risk between coronary artery bypass grafting and percutaneous coronary interventions in the 2013 database.
Three was no industry funding for the work, and Dr. Stein did not have any relevant disclosures.
AT ANA 2017
Key clinical point:
Major finding: There was an 86% greater risk of ischemic stroke after transcatheter aortic valve replacement, compared with surgical aortic valve replacement, and a more than sixfold increased risk of hemorrhagic stroke.
Data source: Database review of more than 44,000 patients
Disclosures: Three was no industry funding for the work, and the lead investigator did not have any relevant disclosures.
Can arterial switch operation impact cognitive deficits?
With dramatic advances of neonatal repair of complex cardiac disease, the population of adults with congenital heart disease (CHD) has increased dramatically, and while studies have shown an increased risk of neurodevelopmental and psychological disorders in these patients, few studies have evaluated their cognitive and psychosocial outcomes. Now, a review of young adults who had an arterial switch operation for transposition of the great arteries in France has found that they have almost twice the rate of cognitive difficulties and more than triple the rate of cognitive impairment as healthy peers.
“Despite satisfactory outcomes in most adults with transposition of the great arteries (TGA), a substantial proportion has cognitive or psychologic difficulties that may reduce their academic success and quality of life,” said lead author David Kalfa, MD, PhD, of Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center and coauthors in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2017;154:1028-35).
The study involved a review of 67 adults aged 18 and older born with TGA between 1984 and 1985 who had an arterial switch operation (ASO) at two hospitals in France: Necker Children’s Hospital in Paris and Marie Lannelongue Hospital in Le Plessis-Robinson. The researchers performed a matched analysis with 43 healthy subjects for age, gender, and education level.
The researchers found that 69% of the TGA patients had an intelligence quotient in the normal range of 85-115. The TGA patients had lower quotients for mean full-scale (94.9 plus or minus 15.3 vs. 103.4 plus or minus 12.3 in healthy subjects; P = 0.003), verbal (96.8 plus or minus 16.2 vs. 102.5 plus or minus 11.5; P =.033) and performance intelligence (93.7 plus or minus 14.6 vs. 103.8 plus or minus 14.3; P less than .001).
The TGA patients also had higher rates of cognitive difficulties, measured as intelligence quotient less than or equal to –1 standard deviation, and cognitive impairment, measured as intelligence quotient less than or equal to –2 standard deviation; 31% vs. 16% (P = .001) for the former and 6% vs. 2% (P = .030) for the latter.
TGA patients with cognitive difficulties had lower educational levels and were also more likely to repeat grades in school, Dr. Kalfa and coauthors noted. “Patients reported an overall satisfactory health-related quality of life,” Dr. Kalfa and coauthors said of the TGA group; “however, those with cognitive or psychologic difficulties reported poorer quality of life.” The researchers identified three predictors of worse outcomes: lower parental socioeconomic and educational status; older age at surgery; and longer hospital stays.
“Our findings suggest that the cognitive morbidities commonly reported in children and adolescents with complex CHD persist into adulthood in individuals with TGA after the ASO,” Dr. Kalfa and coauthors said. Future research should evaluate specific cognitive domains such as attention, memory, and executive functions. “This consideration is important for evaluation of the whole [adult] CHD population because specific cognitive impairments are increasingly documented into adolescence but remain rarely investigated in adulthood,” the researchers said.
Dr. Kalfa and coauthors reported having no financial disclosures.
The findings by Dr. Kalfa and coauthors may point the way to improve cognitive outcomes in children who have the arterial switch operation, said Ryan R. Davies, MD, of A.I duPont Hospital for Children in Wilmington, Del., in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1036-7.) “Modifiable factors may exist both during the perioperative stage (perfusion strategies, intensive care management) and over the longer term (early neurocognitive assessments and interventions,” Dr. Davies said.
That parental socioeconomic status is associated with cognitive performance suggests early intervention and education “may pay long-term dividends,” Dr. Davies said. Future studies should focus on the impact of specific interventions and identify modifiable developmental factors, he said.
Dr. Kalfa and coauthors have provided an “important start” in that direction, Dr. Davies said. “They have shown that the neurodevelopmental deficits seen early in children with CHD persist into adulthood,” he said. “There are also hints here as to where interventions may be effective in ameliorating those deficits.”
Dr. Davies reported having no financial disclosures.
The findings by Dr. Kalfa and coauthors may point the way to improve cognitive outcomes in children who have the arterial switch operation, said Ryan R. Davies, MD, of A.I duPont Hospital for Children in Wilmington, Del., in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1036-7.) “Modifiable factors may exist both during the perioperative stage (perfusion strategies, intensive care management) and over the longer term (early neurocognitive assessments and interventions,” Dr. Davies said.
That parental socioeconomic status is associated with cognitive performance suggests early intervention and education “may pay long-term dividends,” Dr. Davies said. Future studies should focus on the impact of specific interventions and identify modifiable developmental factors, he said.
Dr. Kalfa and coauthors have provided an “important start” in that direction, Dr. Davies said. “They have shown that the neurodevelopmental deficits seen early in children with CHD persist into adulthood,” he said. “There are also hints here as to where interventions may be effective in ameliorating those deficits.”
Dr. Davies reported having no financial disclosures.
The findings by Dr. Kalfa and coauthors may point the way to improve cognitive outcomes in children who have the arterial switch operation, said Ryan R. Davies, MD, of A.I duPont Hospital for Children in Wilmington, Del., in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1036-7.) “Modifiable factors may exist both during the perioperative stage (perfusion strategies, intensive care management) and over the longer term (early neurocognitive assessments and interventions,” Dr. Davies said.
That parental socioeconomic status is associated with cognitive performance suggests early intervention and education “may pay long-term dividends,” Dr. Davies said. Future studies should focus on the impact of specific interventions and identify modifiable developmental factors, he said.
Dr. Kalfa and coauthors have provided an “important start” in that direction, Dr. Davies said. “They have shown that the neurodevelopmental deficits seen early in children with CHD persist into adulthood,” he said. “There are also hints here as to where interventions may be effective in ameliorating those deficits.”
Dr. Davies reported having no financial disclosures.
With dramatic advances of neonatal repair of complex cardiac disease, the population of adults with congenital heart disease (CHD) has increased dramatically, and while studies have shown an increased risk of neurodevelopmental and psychological disorders in these patients, few studies have evaluated their cognitive and psychosocial outcomes. Now, a review of young adults who had an arterial switch operation for transposition of the great arteries in France has found that they have almost twice the rate of cognitive difficulties and more than triple the rate of cognitive impairment as healthy peers.
“Despite satisfactory outcomes in most adults with transposition of the great arteries (TGA), a substantial proportion has cognitive or psychologic difficulties that may reduce their academic success and quality of life,” said lead author David Kalfa, MD, PhD, of Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center and coauthors in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2017;154:1028-35).
The study involved a review of 67 adults aged 18 and older born with TGA between 1984 and 1985 who had an arterial switch operation (ASO) at two hospitals in France: Necker Children’s Hospital in Paris and Marie Lannelongue Hospital in Le Plessis-Robinson. The researchers performed a matched analysis with 43 healthy subjects for age, gender, and education level.
The researchers found that 69% of the TGA patients had an intelligence quotient in the normal range of 85-115. The TGA patients had lower quotients for mean full-scale (94.9 plus or minus 15.3 vs. 103.4 plus or minus 12.3 in healthy subjects; P = 0.003), verbal (96.8 plus or minus 16.2 vs. 102.5 plus or minus 11.5; P =.033) and performance intelligence (93.7 plus or minus 14.6 vs. 103.8 plus or minus 14.3; P less than .001).
The TGA patients also had higher rates of cognitive difficulties, measured as intelligence quotient less than or equal to –1 standard deviation, and cognitive impairment, measured as intelligence quotient less than or equal to –2 standard deviation; 31% vs. 16% (P = .001) for the former and 6% vs. 2% (P = .030) for the latter.
TGA patients with cognitive difficulties had lower educational levels and were also more likely to repeat grades in school, Dr. Kalfa and coauthors noted. “Patients reported an overall satisfactory health-related quality of life,” Dr. Kalfa and coauthors said of the TGA group; “however, those with cognitive or psychologic difficulties reported poorer quality of life.” The researchers identified three predictors of worse outcomes: lower parental socioeconomic and educational status; older age at surgery; and longer hospital stays.
“Our findings suggest that the cognitive morbidities commonly reported in children and adolescents with complex CHD persist into adulthood in individuals with TGA after the ASO,” Dr. Kalfa and coauthors said. Future research should evaluate specific cognitive domains such as attention, memory, and executive functions. “This consideration is important for evaluation of the whole [adult] CHD population because specific cognitive impairments are increasingly documented into adolescence but remain rarely investigated in adulthood,” the researchers said.
Dr. Kalfa and coauthors reported having no financial disclosures.
With dramatic advances of neonatal repair of complex cardiac disease, the population of adults with congenital heart disease (CHD) has increased dramatically, and while studies have shown an increased risk of neurodevelopmental and psychological disorders in these patients, few studies have evaluated their cognitive and psychosocial outcomes. Now, a review of young adults who had an arterial switch operation for transposition of the great arteries in France has found that they have almost twice the rate of cognitive difficulties and more than triple the rate of cognitive impairment as healthy peers.
“Despite satisfactory outcomes in most adults with transposition of the great arteries (TGA), a substantial proportion has cognitive or psychologic difficulties that may reduce their academic success and quality of life,” said lead author David Kalfa, MD, PhD, of Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center and coauthors in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2017;154:1028-35).
The study involved a review of 67 adults aged 18 and older born with TGA between 1984 and 1985 who had an arterial switch operation (ASO) at two hospitals in France: Necker Children’s Hospital in Paris and Marie Lannelongue Hospital in Le Plessis-Robinson. The researchers performed a matched analysis with 43 healthy subjects for age, gender, and education level.
The researchers found that 69% of the TGA patients had an intelligence quotient in the normal range of 85-115. The TGA patients had lower quotients for mean full-scale (94.9 plus or minus 15.3 vs. 103.4 plus or minus 12.3 in healthy subjects; P = 0.003), verbal (96.8 plus or minus 16.2 vs. 102.5 plus or minus 11.5; P =.033) and performance intelligence (93.7 plus or minus 14.6 vs. 103.8 plus or minus 14.3; P less than .001).
The TGA patients also had higher rates of cognitive difficulties, measured as intelligence quotient less than or equal to –1 standard deviation, and cognitive impairment, measured as intelligence quotient less than or equal to –2 standard deviation; 31% vs. 16% (P = .001) for the former and 6% vs. 2% (P = .030) for the latter.
TGA patients with cognitive difficulties had lower educational levels and were also more likely to repeat grades in school, Dr. Kalfa and coauthors noted. “Patients reported an overall satisfactory health-related quality of life,” Dr. Kalfa and coauthors said of the TGA group; “however, those with cognitive or psychologic difficulties reported poorer quality of life.” The researchers identified three predictors of worse outcomes: lower parental socioeconomic and educational status; older age at surgery; and longer hospital stays.
“Our findings suggest that the cognitive morbidities commonly reported in children and adolescents with complex CHD persist into adulthood in individuals with TGA after the ASO,” Dr. Kalfa and coauthors said. Future research should evaluate specific cognitive domains such as attention, memory, and executive functions. “This consideration is important for evaluation of the whole [adult] CHD population because specific cognitive impairments are increasingly documented into adolescence but remain rarely investigated in adulthood,” the researchers said.
Dr. Kalfa and coauthors reported having no financial disclosures.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: A substantial proportion of young adults who had transposition of the great arteries have cognitive or psychological difficulties.
Major finding: Cognitive difficulties were significantly more frequent in the study population than the general population, 31% vs. 16%.
Data source: Age-, gender-, and education level–matched population of 67 young adults with transposition of the great arteries and 43 healthy subjects.
Disclosures: Dr. Kalfa and coauthors reported having no financial disclosures.