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Early, in-hospital shunt failure common among infants
HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.
“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.
“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”
Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.
Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.
In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).
“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.
“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”
He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.
The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.
HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.
“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.
“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”
Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.
Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.
In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).
“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.
“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”
He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.
The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.
HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.
“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.
“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”
Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.
Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.
In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).
“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.
“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”
He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.
The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point:
Major finding: Among neonates and infants who underwent shunt operations, 7.3% experienced early, in-hospital shunt failure.
Data source: A retrospective analysis of 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015.
Disclosures: The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.
Study IDs risk factors for ideal timing of stage 2 palliation following Norwood
HOUSTON – The optimal timing of stage 2 palliation after the Norwood operation depends on certain patient-specific risk factors, but in most cases should be done around 3-4 months of age, results from a multi-center study show.
While previous studies have investigated whether early stage-2 palliation (S2P) can be performed without increased post-S2P mortality, the effect of the timing of S2P on post-Norwood mortality remains unknown, Robert “Jake” Jaquiss, MD, said in an interview in advance of the annual meeting of the Society of Thoracic Surgeons.
“There has been a lot of dispute about how early is too early for S2P,” said Dr. Jaquiss, the study’s senior author, who is professor and division chief of pediatric cardiothoracic surgery at the University of Texas Southwestern Medical Center. “That is one of the few things that is in the control of the doctor. Most of the rest of the decisions are based entirely on the condition of the patient and the patient’s specific anatomy. So the timing of S2P is something that we can truly define most always. What we want to find out is, what is the ideal timing? How early is too early? Is there such a thing as too late?”
In an effort to determine the optimal timing of S2P that both minimizes pre-S2P attrition and maximizes long-term post-S2P survival, Dr. Jaquiss and his associates at 19 other institutions evaluated data from 534 neonates diagnosed with left ventricular outflow tract obstruction that precluded adequate systemic cardiac output through the aortic valve who initially underwent a Norwood operation from 2005 to 2016.
S2P was performed in 377 patients (71%) at a mean age of 5.4 months, while 115 (22%) died after Norwood, and the rest underwent biventricular repair or heart transplantation. After S2P, 38 (10%) died, 248 (66%) underwent Fontan, and the rest were alive awaiting Fontan or underwent heart transplantation.
Risk factors for death after Norwood included requiring pre-Norwood extracorporeal membrane oxygenation (P less than .0001), birth weight of less than 2.5 kg (P less than .0001), modified Blalock-Taussig shunt vs. a right ventricle to pulmonary artery conduit (P = .0003), larger baseline right pulmonary artery diameter (P = .0002), smaller baseline mitral valve diameter (P = .0002), smaller baseline tricuspid valve diameter (P = .0001), and nonwhite race (P = .03).
Risk factors for death after S2P included lower oxygen saturation at pre-S2P clinic visit (P = .02), having moderate or severe pre-S2P right ventricular dysfunction (P = .007), younger age at S2P (P = .03), and longer post-Norwood hospital length of stay (P = .03).
The risk-adjusted, 4-year, post-Norwood survival was 72%, with a confidence interval of 67%-75%. When plotted vs. the age at S2P, risk-adjusted, 4-year, post-Norwood survival for the 534 patients was maximized by S2P at 3-6 months of age. At the same time, risk-adjusted, 4-year survival in low-risk infants was compromised only by undergoing S2P earlier than 3 months of age. In high-risk infants, survival was severely compromised, especially when undergoing S2P earlier than 6 months of age.
“The results reinforced intuitions or expectations that most of the investigators already had,” Dr. Jaquiss said. “But we are in an era where evidence-based medicine is much preferable to intuition-based medicine. I’m very confident in the findings we have. I feel more confident in suggesting that we should be planning these surgeries around 3-4 months of age in usual-risk children and also more confident in suggesting that we need to consider transplantation earlier in children who are perceived to be at high risk. There is some hope [by clinicians in] some centers that you can convert a high-risk prognosis to a lower or intermediate risk prognosis by doing the S2P earlier or at some alternative time. Our data suggests that would not be helpful.”
Dr. Jaquiss and Dr. Meza reported having no financial disclosures.
HOUSTON – The optimal timing of stage 2 palliation after the Norwood operation depends on certain patient-specific risk factors, but in most cases should be done around 3-4 months of age, results from a multi-center study show.
While previous studies have investigated whether early stage-2 palliation (S2P) can be performed without increased post-S2P mortality, the effect of the timing of S2P on post-Norwood mortality remains unknown, Robert “Jake” Jaquiss, MD, said in an interview in advance of the annual meeting of the Society of Thoracic Surgeons.
“There has been a lot of dispute about how early is too early for S2P,” said Dr. Jaquiss, the study’s senior author, who is professor and division chief of pediatric cardiothoracic surgery at the University of Texas Southwestern Medical Center. “That is one of the few things that is in the control of the doctor. Most of the rest of the decisions are based entirely on the condition of the patient and the patient’s specific anatomy. So the timing of S2P is something that we can truly define most always. What we want to find out is, what is the ideal timing? How early is too early? Is there such a thing as too late?”
In an effort to determine the optimal timing of S2P that both minimizes pre-S2P attrition and maximizes long-term post-S2P survival, Dr. Jaquiss and his associates at 19 other institutions evaluated data from 534 neonates diagnosed with left ventricular outflow tract obstruction that precluded adequate systemic cardiac output through the aortic valve who initially underwent a Norwood operation from 2005 to 2016.
S2P was performed in 377 patients (71%) at a mean age of 5.4 months, while 115 (22%) died after Norwood, and the rest underwent biventricular repair or heart transplantation. After S2P, 38 (10%) died, 248 (66%) underwent Fontan, and the rest were alive awaiting Fontan or underwent heart transplantation.
Risk factors for death after Norwood included requiring pre-Norwood extracorporeal membrane oxygenation (P less than .0001), birth weight of less than 2.5 kg (P less than .0001), modified Blalock-Taussig shunt vs. a right ventricle to pulmonary artery conduit (P = .0003), larger baseline right pulmonary artery diameter (P = .0002), smaller baseline mitral valve diameter (P = .0002), smaller baseline tricuspid valve diameter (P = .0001), and nonwhite race (P = .03).
Risk factors for death after S2P included lower oxygen saturation at pre-S2P clinic visit (P = .02), having moderate or severe pre-S2P right ventricular dysfunction (P = .007), younger age at S2P (P = .03), and longer post-Norwood hospital length of stay (P = .03).
The risk-adjusted, 4-year, post-Norwood survival was 72%, with a confidence interval of 67%-75%. When plotted vs. the age at S2P, risk-adjusted, 4-year, post-Norwood survival for the 534 patients was maximized by S2P at 3-6 months of age. At the same time, risk-adjusted, 4-year survival in low-risk infants was compromised only by undergoing S2P earlier than 3 months of age. In high-risk infants, survival was severely compromised, especially when undergoing S2P earlier than 6 months of age.
“The results reinforced intuitions or expectations that most of the investigators already had,” Dr. Jaquiss said. “But we are in an era where evidence-based medicine is much preferable to intuition-based medicine. I’m very confident in the findings we have. I feel more confident in suggesting that we should be planning these surgeries around 3-4 months of age in usual-risk children and also more confident in suggesting that we need to consider transplantation earlier in children who are perceived to be at high risk. There is some hope [by clinicians in] some centers that you can convert a high-risk prognosis to a lower or intermediate risk prognosis by doing the S2P earlier or at some alternative time. Our data suggests that would not be helpful.”
Dr. Jaquiss and Dr. Meza reported having no financial disclosures.
HOUSTON – The optimal timing of stage 2 palliation after the Norwood operation depends on certain patient-specific risk factors, but in most cases should be done around 3-4 months of age, results from a multi-center study show.
While previous studies have investigated whether early stage-2 palliation (S2P) can be performed without increased post-S2P mortality, the effect of the timing of S2P on post-Norwood mortality remains unknown, Robert “Jake” Jaquiss, MD, said in an interview in advance of the annual meeting of the Society of Thoracic Surgeons.
“There has been a lot of dispute about how early is too early for S2P,” said Dr. Jaquiss, the study’s senior author, who is professor and division chief of pediatric cardiothoracic surgery at the University of Texas Southwestern Medical Center. “That is one of the few things that is in the control of the doctor. Most of the rest of the decisions are based entirely on the condition of the patient and the patient’s specific anatomy. So the timing of S2P is something that we can truly define most always. What we want to find out is, what is the ideal timing? How early is too early? Is there such a thing as too late?”
In an effort to determine the optimal timing of S2P that both minimizes pre-S2P attrition and maximizes long-term post-S2P survival, Dr. Jaquiss and his associates at 19 other institutions evaluated data from 534 neonates diagnosed with left ventricular outflow tract obstruction that precluded adequate systemic cardiac output through the aortic valve who initially underwent a Norwood operation from 2005 to 2016.
S2P was performed in 377 patients (71%) at a mean age of 5.4 months, while 115 (22%) died after Norwood, and the rest underwent biventricular repair or heart transplantation. After S2P, 38 (10%) died, 248 (66%) underwent Fontan, and the rest were alive awaiting Fontan or underwent heart transplantation.
Risk factors for death after Norwood included requiring pre-Norwood extracorporeal membrane oxygenation (P less than .0001), birth weight of less than 2.5 kg (P less than .0001), modified Blalock-Taussig shunt vs. a right ventricle to pulmonary artery conduit (P = .0003), larger baseline right pulmonary artery diameter (P = .0002), smaller baseline mitral valve diameter (P = .0002), smaller baseline tricuspid valve diameter (P = .0001), and nonwhite race (P = .03).
Risk factors for death after S2P included lower oxygen saturation at pre-S2P clinic visit (P = .02), having moderate or severe pre-S2P right ventricular dysfunction (P = .007), younger age at S2P (P = .03), and longer post-Norwood hospital length of stay (P = .03).
The risk-adjusted, 4-year, post-Norwood survival was 72%, with a confidence interval of 67%-75%. When plotted vs. the age at S2P, risk-adjusted, 4-year, post-Norwood survival for the 534 patients was maximized by S2P at 3-6 months of age. At the same time, risk-adjusted, 4-year survival in low-risk infants was compromised only by undergoing S2P earlier than 3 months of age. In high-risk infants, survival was severely compromised, especially when undergoing S2P earlier than 6 months of age.
“The results reinforced intuitions or expectations that most of the investigators already had,” Dr. Jaquiss said. “But we are in an era where evidence-based medicine is much preferable to intuition-based medicine. I’m very confident in the findings we have. I feel more confident in suggesting that we should be planning these surgeries around 3-4 months of age in usual-risk children and also more confident in suggesting that we need to consider transplantation earlier in children who are perceived to be at high risk. There is some hope [by clinicians in] some centers that you can convert a high-risk prognosis to a lower or intermediate risk prognosis by doing the S2P earlier or at some alternative time. Our data suggests that would not be helpful.”
Dr. Jaquiss and Dr. Meza reported having no financial disclosures.
Key clinical point:
Major finding: When plotted vs. the age at stage 2 palliation, risk-adjusted, 4-year, post-Norwood survival for the 534 patients was maximized by S2P at 3-6 months of age.
Data source: A multi-institutional analysis of 534 neonates diagnosed with left ventricular outflow tract obstruction that precluded adequate systemic cardiac output through the aortic valve who initially underwent a Norwood operation from 2005 to 2016.
Disclosures: Dr. Jaquiss and Dr. Meza reported having no financial disclosures.
New thinking on septal myectomy vs. alcohol ablation for obstructive cardiomyopathy
SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.
Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).
“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.
Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.
At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.
“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”
In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.
“One in four treated patients will not benefit,” the cardiologist emphasized.
The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.
When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.
Dr. Nishimura reported having no financial conflicts.
SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.
Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).
“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.
Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.
At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.
“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”
In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.
“One in four treated patients will not benefit,” the cardiologist emphasized.
The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.
When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.
Dr. Nishimura reported having no financial conflicts.
SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.
Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).
“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.
Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.
At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.
“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”
In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.
“One in four treated patients will not benefit,” the cardiologist emphasized.
The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.
When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.
Dr. Nishimura reported having no financial conflicts.
Survey finds link between e-cigarette use and high-risk behaviors
High school students who use electronic vapor products (EVPs), whether alone or in combination with cigarette smoking, are more likely to engage in violence, substance abuse, and other high-risk behaviors, compared with nonusers, according to the results of a national survey.
“Given that EVPs are relatively new to the U.S. marketplace, little is known about the use of these products in the context of other health behaviors, which can persist throughout life and contribute to significant morbidity and mortality during adolescence and adulthood,” Zewditu Demissie, PhD, and her associates wrote in a study published online in the Jan. 23, 2017, issue of Pediatrics. They went on to note that to date, “studies on the association between EVPs and health-risk behaviors among adolescents and young adults has been limited to examining the associations between e-cigarette and substance use. These studies have found that use of e-cigarettes was associated with alcohol use, binge drinking, and marijuana use.”
Of the 15,624 respondents, 74% reported that they did not smoke cigarettes or use EVPs, while 3% smoked cigarettes only, 16% used EVPs only, and 8% used both cigarettes and EVPs.
Compared with nonusers, cigarette-only smokers, EVP-only users, and dual users were significantly more likely to:
• Engage in a physical fight (prevalence ratio range, 1.7-2.9).
• Attempt suicide (PR range, 1.9-4.0).
• Currently drink alcohol (PR range, 2.6-3.3).
• Currently use marijuana (PR range, 3.5-5.2).
• Report nonmedical use of prescription drugs (PR range, 2.3-4.1).
• Be currently sexually active (PR range, 1.9-2.3).
“Engaging in health-risk behaviors did not generally differ between EVP-only users and cigarette-only smokers,” the researchers wrote. “However, cigarette-only smokers were significantly more likely than EVP-only users to attempt suicide, ever use synthetic marijuana, have four or more lifetime sexual partners, drink soda three or more times/day, and be physically active less than 7 days in the 7 days before the survey.”
Dr. Demissie and her associates concluded that the findings “underscore the importance of comprehensive efforts to address health-risk behaviors among adolescents, including prevention strategies focused on all forms of tobacco use, including EVPs. Additionally, educational and counseling efforts focusing on the harms associated with adolescent tobacco use, including EVPs, are critical.”
They acknowledged certain limitations of the study, including its observational design and the fact that Youth Risk Behavior Survey data are self-reported.
The investigators reported having no relevant financial disclosures.
“Recent longitudinal research has provided an unpleasant surprise: Among initial nonsmokers, those who use e-cigarettes are more likely to start smoking combustible cigarettes. This puts a somewhat different light on the situation. If e-cigarettes are without risk, it does not matter much if they attract new users. Being related to smoking onset, however, puts a behavioral risk into the picture. The finding of associations with other health-risk behaviors augments concern because, as the authors note, the odds of experiencing poor health increase with the addition of each unhealthy behavior. And importantly, Demissie et al. show that among adolescent smokers, those who use e-cigarettes actually smoke more frequently, an effect that is contrary to the hopes of harm reduction advocates and has now been found internationally.
“Are e-cigarettes going to replace traditional cigarettes, or are they operating to recruit a new audience of adolescents to tobacco products? Our wish is for the former. But at present the empirical evidence looks more like the latter. We need surveillance and mechanism research to understand what e-cigarettes will mean for youth risk status. However, there is enough evidence now to advocate programs for educating teenagers about e-cigarettes.”
Thomas A. Wills, PhD., is with the Cancer Prevention and Control Program at the University of Hawaii Cancer Center, Honolulu. His views are excerpted from a commentary published online in response to the study by Dr. Demissie et al. (Pediatrics. 2017 Jan 23. doi: 10.1542/peds.2016-3736). This work was supported by grants from the National Cancer Institute. Dr. Wills reported having no relevant financial disclosures.
“Recent longitudinal research has provided an unpleasant surprise: Among initial nonsmokers, those who use e-cigarettes are more likely to start smoking combustible cigarettes. This puts a somewhat different light on the situation. If e-cigarettes are without risk, it does not matter much if they attract new users. Being related to smoking onset, however, puts a behavioral risk into the picture. The finding of associations with other health-risk behaviors augments concern because, as the authors note, the odds of experiencing poor health increase with the addition of each unhealthy behavior. And importantly, Demissie et al. show that among adolescent smokers, those who use e-cigarettes actually smoke more frequently, an effect that is contrary to the hopes of harm reduction advocates and has now been found internationally.
“Are e-cigarettes going to replace traditional cigarettes, or are they operating to recruit a new audience of adolescents to tobacco products? Our wish is for the former. But at present the empirical evidence looks more like the latter. We need surveillance and mechanism research to understand what e-cigarettes will mean for youth risk status. However, there is enough evidence now to advocate programs for educating teenagers about e-cigarettes.”
Thomas A. Wills, PhD., is with the Cancer Prevention and Control Program at the University of Hawaii Cancer Center, Honolulu. His views are excerpted from a commentary published online in response to the study by Dr. Demissie et al. (Pediatrics. 2017 Jan 23. doi: 10.1542/peds.2016-3736). This work was supported by grants from the National Cancer Institute. Dr. Wills reported having no relevant financial disclosures.
“Recent longitudinal research has provided an unpleasant surprise: Among initial nonsmokers, those who use e-cigarettes are more likely to start smoking combustible cigarettes. This puts a somewhat different light on the situation. If e-cigarettes are without risk, it does not matter much if they attract new users. Being related to smoking onset, however, puts a behavioral risk into the picture. The finding of associations with other health-risk behaviors augments concern because, as the authors note, the odds of experiencing poor health increase with the addition of each unhealthy behavior. And importantly, Demissie et al. show that among adolescent smokers, those who use e-cigarettes actually smoke more frequently, an effect that is contrary to the hopes of harm reduction advocates and has now been found internationally.
“Are e-cigarettes going to replace traditional cigarettes, or are they operating to recruit a new audience of adolescents to tobacco products? Our wish is for the former. But at present the empirical evidence looks more like the latter. We need surveillance and mechanism research to understand what e-cigarettes will mean for youth risk status. However, there is enough evidence now to advocate programs for educating teenagers about e-cigarettes.”
Thomas A. Wills, PhD., is with the Cancer Prevention and Control Program at the University of Hawaii Cancer Center, Honolulu. His views are excerpted from a commentary published online in response to the study by Dr. Demissie et al. (Pediatrics. 2017 Jan 23. doi: 10.1542/peds.2016-3736). This work was supported by grants from the National Cancer Institute. Dr. Wills reported having no relevant financial disclosures.
High school students who use electronic vapor products (EVPs), whether alone or in combination with cigarette smoking, are more likely to engage in violence, substance abuse, and other high-risk behaviors, compared with nonusers, according to the results of a national survey.
“Given that EVPs are relatively new to the U.S. marketplace, little is known about the use of these products in the context of other health behaviors, which can persist throughout life and contribute to significant morbidity and mortality during adolescence and adulthood,” Zewditu Demissie, PhD, and her associates wrote in a study published online in the Jan. 23, 2017, issue of Pediatrics. They went on to note that to date, “studies on the association between EVPs and health-risk behaviors among adolescents and young adults has been limited to examining the associations between e-cigarette and substance use. These studies have found that use of e-cigarettes was associated with alcohol use, binge drinking, and marijuana use.”
Of the 15,624 respondents, 74% reported that they did not smoke cigarettes or use EVPs, while 3% smoked cigarettes only, 16% used EVPs only, and 8% used both cigarettes and EVPs.
Compared with nonusers, cigarette-only smokers, EVP-only users, and dual users were significantly more likely to:
• Engage in a physical fight (prevalence ratio range, 1.7-2.9).
• Attempt suicide (PR range, 1.9-4.0).
• Currently drink alcohol (PR range, 2.6-3.3).
• Currently use marijuana (PR range, 3.5-5.2).
• Report nonmedical use of prescription drugs (PR range, 2.3-4.1).
• Be currently sexually active (PR range, 1.9-2.3).
“Engaging in health-risk behaviors did not generally differ between EVP-only users and cigarette-only smokers,” the researchers wrote. “However, cigarette-only smokers were significantly more likely than EVP-only users to attempt suicide, ever use synthetic marijuana, have four or more lifetime sexual partners, drink soda three or more times/day, and be physically active less than 7 days in the 7 days before the survey.”
Dr. Demissie and her associates concluded that the findings “underscore the importance of comprehensive efforts to address health-risk behaviors among adolescents, including prevention strategies focused on all forms of tobacco use, including EVPs. Additionally, educational and counseling efforts focusing on the harms associated with adolescent tobacco use, including EVPs, are critical.”
They acknowledged certain limitations of the study, including its observational design and the fact that Youth Risk Behavior Survey data are self-reported.
The investigators reported having no relevant financial disclosures.
High school students who use electronic vapor products (EVPs), whether alone or in combination with cigarette smoking, are more likely to engage in violence, substance abuse, and other high-risk behaviors, compared with nonusers, according to the results of a national survey.
“Given that EVPs are relatively new to the U.S. marketplace, little is known about the use of these products in the context of other health behaviors, which can persist throughout life and contribute to significant morbidity and mortality during adolescence and adulthood,” Zewditu Demissie, PhD, and her associates wrote in a study published online in the Jan. 23, 2017, issue of Pediatrics. They went on to note that to date, “studies on the association between EVPs and health-risk behaviors among adolescents and young adults has been limited to examining the associations between e-cigarette and substance use. These studies have found that use of e-cigarettes was associated with alcohol use, binge drinking, and marijuana use.”
Of the 15,624 respondents, 74% reported that they did not smoke cigarettes or use EVPs, while 3% smoked cigarettes only, 16% used EVPs only, and 8% used both cigarettes and EVPs.
Compared with nonusers, cigarette-only smokers, EVP-only users, and dual users were significantly more likely to:
• Engage in a physical fight (prevalence ratio range, 1.7-2.9).
• Attempt suicide (PR range, 1.9-4.0).
• Currently drink alcohol (PR range, 2.6-3.3).
• Currently use marijuana (PR range, 3.5-5.2).
• Report nonmedical use of prescription drugs (PR range, 2.3-4.1).
• Be currently sexually active (PR range, 1.9-2.3).
“Engaging in health-risk behaviors did not generally differ between EVP-only users and cigarette-only smokers,” the researchers wrote. “However, cigarette-only smokers were significantly more likely than EVP-only users to attempt suicide, ever use synthetic marijuana, have four or more lifetime sexual partners, drink soda three or more times/day, and be physically active less than 7 days in the 7 days before the survey.”
Dr. Demissie and her associates concluded that the findings “underscore the importance of comprehensive efforts to address health-risk behaviors among adolescents, including prevention strategies focused on all forms of tobacco use, including EVPs. Additionally, educational and counseling efforts focusing on the harms associated with adolescent tobacco use, including EVPs, are critical.”
They acknowledged certain limitations of the study, including its observational design and the fact that Youth Risk Behavior Survey data are self-reported.
The investigators reported having no relevant financial disclosures.
FROM PEDIATRICS
Key clinical point:
Major finding: Compared with nonusers, cigarette-only smokers, electronic vapor products–only users, and dual users were significantly more likely to engage in a physical fight (prevalence ratio range, 1.7-2.3), to currently use marijuana (PR range, 3.5-5.2), and to be currently sexually active (PR range, 1.9-2.3).
Data source: An analysis of responses from 15,624 high school students who completed the 2015 national Youth Risk Behavior Survey.
Disclosures: The researchers reported having no relevant financial disclosures.
Echocardiography can benefit use of stented bovine graft for MVR in infants
Mitral valve replacement in infants and young children is complicated because appropriately sized prostheses are difficult to come by and these patients need replacements later on as they continue to grow – thus the high rates of reintervention and death. Pediatric cardiac surgery specialists at Boston Children’s Hospital are among the few that have used stented jugular vein grafts in these patients, and they have reported on a refinement of their technique that uses echocardiography before and after graft placement to obtain valuable measurements for sizing and implanting a prosthesis and for identifying patients at risk of complications.
Lindsay R. Freud, MD, and her associates reported in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery on pre- and postoperative echocardiograms of 24 patients who had mitral valve replacement (MVR) with the Melody stent-mounted, valved bovine jugular vein graft (Medtronic) (J Thorac Cardiovasc Surg. 2017;153:153-60). The device, which is approved for transcatheter pulmonary valve replacement, was adapted for implantation into the mitral position, an indication that is not yet Food and Drug Administration approved. “With the increasing use of the Melody valve in the mitral position in infants and young children, we sought to provide a framework for both pre- and early postoperative echocardiographic assessment,” Dr. Freud and her coauthors said.
“The potential dimensions often had normal z scores with fair correlation with intraoperative Melody dilation,” the investigators said. They also found that a ratio of the narrowest subaortic region in systole to the actual MV dimension (SubA:MV) less than 0.5 was associated with postoperative left ventricular outflow tract obstruction (LVOTO), which occurred in four patients. The median age of the study group was 8.5 months.
“Postoperatively, mitral gradients substantially improved, with low values relative to the effective orifice area of the Melody valve,” Dr. Freud and her associates said. None of the patients had significant regurgitation or perivalvar leak.
In early reports of the Melody valve in infants and small children, the surgeons determined the size of the replacement valve during the operation itself. Despite encouraging early results, reports of complications such as LVOTO soon followed. The Children’s Hospital Boston researchers undertook the study to determine if echocardiography before surgery would help to identify the correct valve size for expansion and predict which patients would be at risk for LVOTO.
“The preoperative SubA:MV ratio may help assess the risk for postoperative LVOTO, which is an important complication,” Dr. Freud and coauthors said. The presence of LVOTO preoperatively was also a risk factor, but only one of eight patients with an atrioventricular canal defect developed LVOTO. In patients with a SubA:MV ratio less than 0.5, preoperative LVOTO, or any other anatomic risk factor, surgeons should consider options to prevent LVOTO, Dr. Freud and her associates said. Those alternatives include more aggressive resection of stent material, atrial displacement of the valve, or less aggressive distal expansion of the valve.
Postoperative echocardiography enabled Dr. Freud and her coauthors to outline baseline values for the Melody valve in the mitral position by maximum intraoperative balloon diameter, ranging from 1 cm to 1.8 cm in 0.2-cm steps, and depending on five measurements at each step: peak and mean gradients, peak velocity, effective orifice area, and indexed effective orifice area.
“Validation of candidacy for Melody MVR and noninvasive assessment among larger series of patient will be necessary as greater experience with the Melody valve evolves,” Dr. Freud and her associates concluded.
Coauthor Sitaram Emani, MD, has filed a patent for an expandable valve through Boston Children’s Hospital. Dr. Freud and her other coauthors had no financial relationships to disclose.
The Melody valve is an “appealing solution” for MVR in infants and small children, Patrick Myers, MD, of Geneva University Hospitals said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:151-2) “This contribution brings further data to support Melody MVR,” he said of the report by Dr. Freud and her colleagues.
However, Dr. Myers noted that beyond the Boston Children’s Hospital experience, only two other reports of the Melody valve in the mitral position in children exist. “There are several outstanding technical issues that need to be investigated for the use of the Melody valve in the mitral position,” he said. Among those issues is the length of the stent itself – 28 mm, which can lead to LVOTO after placement “in a diminutive ventricle.” The fact that “only” four patients in the study group developed LVOTO after Melody MVR is “reassuring with regard to this theoretic limitation,” Dr. Myers said. “And the echocardiographic ratio of the narrowest subaortic region in systole to the actual mitral valve dimension could be of use in deciding when to be more aggressive in preventing LVOTO,” he said.
Dr. Myers also said that this report answered some questions about the durability of a venous valve under systemic pressures, but added, “Further echocardiographic and clinical follow-up data in this very challenging population are required,” he said.
Dr. Myers had no financial relationships to disclose.
The Melody valve is an “appealing solution” for MVR in infants and small children, Patrick Myers, MD, of Geneva University Hospitals said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:151-2) “This contribution brings further data to support Melody MVR,” he said of the report by Dr. Freud and her colleagues.
However, Dr. Myers noted that beyond the Boston Children’s Hospital experience, only two other reports of the Melody valve in the mitral position in children exist. “There are several outstanding technical issues that need to be investigated for the use of the Melody valve in the mitral position,” he said. Among those issues is the length of the stent itself – 28 mm, which can lead to LVOTO after placement “in a diminutive ventricle.” The fact that “only” four patients in the study group developed LVOTO after Melody MVR is “reassuring with regard to this theoretic limitation,” Dr. Myers said. “And the echocardiographic ratio of the narrowest subaortic region in systole to the actual mitral valve dimension could be of use in deciding when to be more aggressive in preventing LVOTO,” he said.
Dr. Myers also said that this report answered some questions about the durability of a venous valve under systemic pressures, but added, “Further echocardiographic and clinical follow-up data in this very challenging population are required,” he said.
Dr. Myers had no financial relationships to disclose.
The Melody valve is an “appealing solution” for MVR in infants and small children, Patrick Myers, MD, of Geneva University Hospitals said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153:151-2) “This contribution brings further data to support Melody MVR,” he said of the report by Dr. Freud and her colleagues.
However, Dr. Myers noted that beyond the Boston Children’s Hospital experience, only two other reports of the Melody valve in the mitral position in children exist. “There are several outstanding technical issues that need to be investigated for the use of the Melody valve in the mitral position,” he said. Among those issues is the length of the stent itself – 28 mm, which can lead to LVOTO after placement “in a diminutive ventricle.” The fact that “only” four patients in the study group developed LVOTO after Melody MVR is “reassuring with regard to this theoretic limitation,” Dr. Myers said. “And the echocardiographic ratio of the narrowest subaortic region in systole to the actual mitral valve dimension could be of use in deciding when to be more aggressive in preventing LVOTO,” he said.
Dr. Myers also said that this report answered some questions about the durability of a venous valve under systemic pressures, but added, “Further echocardiographic and clinical follow-up data in this very challenging population are required,” he said.
Dr. Myers had no financial relationships to disclose.
Mitral valve replacement in infants and young children is complicated because appropriately sized prostheses are difficult to come by and these patients need replacements later on as they continue to grow – thus the high rates of reintervention and death. Pediatric cardiac surgery specialists at Boston Children’s Hospital are among the few that have used stented jugular vein grafts in these patients, and they have reported on a refinement of their technique that uses echocardiography before and after graft placement to obtain valuable measurements for sizing and implanting a prosthesis and for identifying patients at risk of complications.
Lindsay R. Freud, MD, and her associates reported in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery on pre- and postoperative echocardiograms of 24 patients who had mitral valve replacement (MVR) with the Melody stent-mounted, valved bovine jugular vein graft (Medtronic) (J Thorac Cardiovasc Surg. 2017;153:153-60). The device, which is approved for transcatheter pulmonary valve replacement, was adapted for implantation into the mitral position, an indication that is not yet Food and Drug Administration approved. “With the increasing use of the Melody valve in the mitral position in infants and young children, we sought to provide a framework for both pre- and early postoperative echocardiographic assessment,” Dr. Freud and her coauthors said.
“The potential dimensions often had normal z scores with fair correlation with intraoperative Melody dilation,” the investigators said. They also found that a ratio of the narrowest subaortic region in systole to the actual MV dimension (SubA:MV) less than 0.5 was associated with postoperative left ventricular outflow tract obstruction (LVOTO), which occurred in four patients. The median age of the study group was 8.5 months.
“Postoperatively, mitral gradients substantially improved, with low values relative to the effective orifice area of the Melody valve,” Dr. Freud and her associates said. None of the patients had significant regurgitation or perivalvar leak.
In early reports of the Melody valve in infants and small children, the surgeons determined the size of the replacement valve during the operation itself. Despite encouraging early results, reports of complications such as LVOTO soon followed. The Children’s Hospital Boston researchers undertook the study to determine if echocardiography before surgery would help to identify the correct valve size for expansion and predict which patients would be at risk for LVOTO.
“The preoperative SubA:MV ratio may help assess the risk for postoperative LVOTO, which is an important complication,” Dr. Freud and coauthors said. The presence of LVOTO preoperatively was also a risk factor, but only one of eight patients with an atrioventricular canal defect developed LVOTO. In patients with a SubA:MV ratio less than 0.5, preoperative LVOTO, or any other anatomic risk factor, surgeons should consider options to prevent LVOTO, Dr. Freud and her associates said. Those alternatives include more aggressive resection of stent material, atrial displacement of the valve, or less aggressive distal expansion of the valve.
Postoperative echocardiography enabled Dr. Freud and her coauthors to outline baseline values for the Melody valve in the mitral position by maximum intraoperative balloon diameter, ranging from 1 cm to 1.8 cm in 0.2-cm steps, and depending on five measurements at each step: peak and mean gradients, peak velocity, effective orifice area, and indexed effective orifice area.
“Validation of candidacy for Melody MVR and noninvasive assessment among larger series of patient will be necessary as greater experience with the Melody valve evolves,” Dr. Freud and her associates concluded.
Coauthor Sitaram Emani, MD, has filed a patent for an expandable valve through Boston Children’s Hospital. Dr. Freud and her other coauthors had no financial relationships to disclose.
Mitral valve replacement in infants and young children is complicated because appropriately sized prostheses are difficult to come by and these patients need replacements later on as they continue to grow – thus the high rates of reintervention and death. Pediatric cardiac surgery specialists at Boston Children’s Hospital are among the few that have used stented jugular vein grafts in these patients, and they have reported on a refinement of their technique that uses echocardiography before and after graft placement to obtain valuable measurements for sizing and implanting a prosthesis and for identifying patients at risk of complications.
Lindsay R. Freud, MD, and her associates reported in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery on pre- and postoperative echocardiograms of 24 patients who had mitral valve replacement (MVR) with the Melody stent-mounted, valved bovine jugular vein graft (Medtronic) (J Thorac Cardiovasc Surg. 2017;153:153-60). The device, which is approved for transcatheter pulmonary valve replacement, was adapted for implantation into the mitral position, an indication that is not yet Food and Drug Administration approved. “With the increasing use of the Melody valve in the mitral position in infants and young children, we sought to provide a framework for both pre- and early postoperative echocardiographic assessment,” Dr. Freud and her coauthors said.
“The potential dimensions often had normal z scores with fair correlation with intraoperative Melody dilation,” the investigators said. They also found that a ratio of the narrowest subaortic region in systole to the actual MV dimension (SubA:MV) less than 0.5 was associated with postoperative left ventricular outflow tract obstruction (LVOTO), which occurred in four patients. The median age of the study group was 8.5 months.
“Postoperatively, mitral gradients substantially improved, with low values relative to the effective orifice area of the Melody valve,” Dr. Freud and her associates said. None of the patients had significant regurgitation or perivalvar leak.
In early reports of the Melody valve in infants and small children, the surgeons determined the size of the replacement valve during the operation itself. Despite encouraging early results, reports of complications such as LVOTO soon followed. The Children’s Hospital Boston researchers undertook the study to determine if echocardiography before surgery would help to identify the correct valve size for expansion and predict which patients would be at risk for LVOTO.
“The preoperative SubA:MV ratio may help assess the risk for postoperative LVOTO, which is an important complication,” Dr. Freud and coauthors said. The presence of LVOTO preoperatively was also a risk factor, but only one of eight patients with an atrioventricular canal defect developed LVOTO. In patients with a SubA:MV ratio less than 0.5, preoperative LVOTO, or any other anatomic risk factor, surgeons should consider options to prevent LVOTO, Dr. Freud and her associates said. Those alternatives include more aggressive resection of stent material, atrial displacement of the valve, or less aggressive distal expansion of the valve.
Postoperative echocardiography enabled Dr. Freud and her coauthors to outline baseline values for the Melody valve in the mitral position by maximum intraoperative balloon diameter, ranging from 1 cm to 1.8 cm in 0.2-cm steps, and depending on five measurements at each step: peak and mean gradients, peak velocity, effective orifice area, and indexed effective orifice area.
“Validation of candidacy for Melody MVR and noninvasive assessment among larger series of patient will be necessary as greater experience with the Melody valve evolves,” Dr. Freud and her associates concluded.
Coauthor Sitaram Emani, MD, has filed a patent for an expandable valve through Boston Children’s Hospital. Dr. Freud and her other coauthors had no financial relationships to disclose.
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Preoperative echocardiography may help guide placement of modified stented jugular vein grafts in infants and small children with hypoplastic mitral and aortic valves.
Major finding: Echocardiography showed that a ratio of the narrowest subaortic region in systole to the actual mitral valve dimension of less than 0.5 was associated with postoperative left ventricular outflow tract obstruction.
Data source: Single-center, retrospective review of 24 patients who underwent mitral valve replacement with modified stented jugular vein grafts from March 2010 to March 2015.
Disclosures: Coauthor Sitaram Emani, MD, has filed a patent for an expandable valve through Boston Children’s Hospital. Dr. Freud and her other coauthors had no financial relationships to disclose.
Hybrid procedures may be better option for LVOTO in lower-weight neonates
Little outcomes data have been published comparing hybrid and Norwood stage 1 procedures for newborns with critical left ventricular outflow tract obstruction (LVOTO), but a prospective analysis of more than 500 operations over 9 years reported that while the Norwood has better survival rates overall, hybrid procedures may improve survival in low-birth-weight newborns.
“Although lower birth weight was identified as an important risk factor for death for the entire cohort, the detrimental impact of low birth weight was mitigated, to some degree, for patients who underwent a hybrid procedure,” said Travis Wilder, MD, of the Congenital Heart Surgeons’ Society (CHSS) Data Center, and his coauthors. They reported their findings in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (153:163-72).
Norwood operations involve major surgical reconstruction along with exposure to cardiopulmonary bypass (CPB), with either deep hypothermic circulatory arrest (DHCA) or regional cerebral perfusion, during aortic arch reconstruction. Previous reports have linked CPB to postoperative hemodynamic instability, complications, and death (Ann Thorac Surg. 2009 Jun;87:1885-92). “In addition, the early physiological stress imposed on neonates after Norwood operations raises concerns regarding adverse neurodevelopment,” Dr. Wilder and his coauthors wrote.
Dr. Wilder and his coauthors pointed out that the hybrid procedure has emerged to avoid CPB and DHCA or regional cerebral perfusion and the potential resulting physiologic instability. “In this light, hybrid palliation may be perceived as a lower-risk alternative to Norwood operations, especially for patients considered at high risk for mortality,” the researchers said. Despite that perception, the actual survival “remains incompletely defined,” they said.
The overall average 4-year unadjusted survival for the entire study population was 65%, but those who had the NW-RVPA procedure had significantly improved survival (73%) vs. both the NW-BT (61%) and the hybrid groups (60%).
Those who had the hybrid procedure were older at stage 1 (12 days vs. 8 and 6 days, respectively for NW-BT and NW-RVPA) and had lower birth weight (2.9 kg vs. 3.2 kg and 3.15 kg, respectively). Hybrid patients also had a higher prevalence of baseline right ventricle dysfunction, were more likely to have baseline tricuspid valve regurgitation, and had a lower prevalence of aortic and mitral valve atresia.
For all patients, birth weight of 2.0-2.5 kg had a strong association with poor survival, Dr. Wilder and his coauthors reported, but the drop-off in survival for low-birth-weight neonates was greater in the Norwood group than in the hybrid group. “This finding suggests that hybrid procedures may offer a modest survival advantage over NW-RVPA at birth weight less than or equal to 2.0 kg and over NW-BT at birth weight less than or equal to 3.0 kg,” the researchers said.
Dr. Wilder and his coauthors had no financial relationships to disclose.
While the study by Dr. Wilder and his coauthors may have drawn an accurate conclusion about low-birth-weight newborns possibly benefiting from a hybrid procedure for hypoplastic left heart syndrome, the number of patients in each strategy was small, Carlos M. Mery, MD, MPH, of Texas Children’s Hospital/Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017 Jan;153:173-4).
Dr. Mery noted other limitations of the study, namely the heterogeneity of procedures by participating center. “Of the 20 centers, only 11 performed any hybrid procedures, and 1 center accounted for 42% of all hybrid procedures performed,” he said. “Because centers may be associated with possibly unaccounted risk factors and different learning curves, the conclusions may not be easily generalizable.”
The conclusion that newborns of lower birth weight may benefit from the hybrid procedure helps to bring clarity for which patients may benefit from a specific procedure, Dr. Mery said. “We seem to be getting closer to the ultimate goal of being able to offer each individual patient the management strategy that will lead to the best possible outcome, not only for quantity but also for quality of life,” Dr. Mery said.
Dr. Mery had no financial relationships to disclose.
While the study by Dr. Wilder and his coauthors may have drawn an accurate conclusion about low-birth-weight newborns possibly benefiting from a hybrid procedure for hypoplastic left heart syndrome, the number of patients in each strategy was small, Carlos M. Mery, MD, MPH, of Texas Children’s Hospital/Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017 Jan;153:173-4).
Dr. Mery noted other limitations of the study, namely the heterogeneity of procedures by participating center. “Of the 20 centers, only 11 performed any hybrid procedures, and 1 center accounted for 42% of all hybrid procedures performed,” he said. “Because centers may be associated with possibly unaccounted risk factors and different learning curves, the conclusions may not be easily generalizable.”
The conclusion that newborns of lower birth weight may benefit from the hybrid procedure helps to bring clarity for which patients may benefit from a specific procedure, Dr. Mery said. “We seem to be getting closer to the ultimate goal of being able to offer each individual patient the management strategy that will lead to the best possible outcome, not only for quantity but also for quality of life,” Dr. Mery said.
Dr. Mery had no financial relationships to disclose.
While the study by Dr. Wilder and his coauthors may have drawn an accurate conclusion about low-birth-weight newborns possibly benefiting from a hybrid procedure for hypoplastic left heart syndrome, the number of patients in each strategy was small, Carlos M. Mery, MD, MPH, of Texas Children’s Hospital/Baylor College of Medicine, Houston, said in his invited commentary (J Thorac Cardiovasc Surg. 2017 Jan;153:173-4).
Dr. Mery noted other limitations of the study, namely the heterogeneity of procedures by participating center. “Of the 20 centers, only 11 performed any hybrid procedures, and 1 center accounted for 42% of all hybrid procedures performed,” he said. “Because centers may be associated with possibly unaccounted risk factors and different learning curves, the conclusions may not be easily generalizable.”
The conclusion that newborns of lower birth weight may benefit from the hybrid procedure helps to bring clarity for which patients may benefit from a specific procedure, Dr. Mery said. “We seem to be getting closer to the ultimate goal of being able to offer each individual patient the management strategy that will lead to the best possible outcome, not only for quantity but also for quality of life,” Dr. Mery said.
Dr. Mery had no financial relationships to disclose.
Little outcomes data have been published comparing hybrid and Norwood stage 1 procedures for newborns with critical left ventricular outflow tract obstruction (LVOTO), but a prospective analysis of more than 500 operations over 9 years reported that while the Norwood has better survival rates overall, hybrid procedures may improve survival in low-birth-weight newborns.
“Although lower birth weight was identified as an important risk factor for death for the entire cohort, the detrimental impact of low birth weight was mitigated, to some degree, for patients who underwent a hybrid procedure,” said Travis Wilder, MD, of the Congenital Heart Surgeons’ Society (CHSS) Data Center, and his coauthors. They reported their findings in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (153:163-72).
Norwood operations involve major surgical reconstruction along with exposure to cardiopulmonary bypass (CPB), with either deep hypothermic circulatory arrest (DHCA) or regional cerebral perfusion, during aortic arch reconstruction. Previous reports have linked CPB to postoperative hemodynamic instability, complications, and death (Ann Thorac Surg. 2009 Jun;87:1885-92). “In addition, the early physiological stress imposed on neonates after Norwood operations raises concerns regarding adverse neurodevelopment,” Dr. Wilder and his coauthors wrote.
Dr. Wilder and his coauthors pointed out that the hybrid procedure has emerged to avoid CPB and DHCA or regional cerebral perfusion and the potential resulting physiologic instability. “In this light, hybrid palliation may be perceived as a lower-risk alternative to Norwood operations, especially for patients considered at high risk for mortality,” the researchers said. Despite that perception, the actual survival “remains incompletely defined,” they said.
The overall average 4-year unadjusted survival for the entire study population was 65%, but those who had the NW-RVPA procedure had significantly improved survival (73%) vs. both the NW-BT (61%) and the hybrid groups (60%).
Those who had the hybrid procedure were older at stage 1 (12 days vs. 8 and 6 days, respectively for NW-BT and NW-RVPA) and had lower birth weight (2.9 kg vs. 3.2 kg and 3.15 kg, respectively). Hybrid patients also had a higher prevalence of baseline right ventricle dysfunction, were more likely to have baseline tricuspid valve regurgitation, and had a lower prevalence of aortic and mitral valve atresia.
For all patients, birth weight of 2.0-2.5 kg had a strong association with poor survival, Dr. Wilder and his coauthors reported, but the drop-off in survival for low-birth-weight neonates was greater in the Norwood group than in the hybrid group. “This finding suggests that hybrid procedures may offer a modest survival advantage over NW-RVPA at birth weight less than or equal to 2.0 kg and over NW-BT at birth weight less than or equal to 3.0 kg,” the researchers said.
Dr. Wilder and his coauthors had no financial relationships to disclose.
Little outcomes data have been published comparing hybrid and Norwood stage 1 procedures for newborns with critical left ventricular outflow tract obstruction (LVOTO), but a prospective analysis of more than 500 operations over 9 years reported that while the Norwood has better survival rates overall, hybrid procedures may improve survival in low-birth-weight newborns.
“Although lower birth weight was identified as an important risk factor for death for the entire cohort, the detrimental impact of low birth weight was mitigated, to some degree, for patients who underwent a hybrid procedure,” said Travis Wilder, MD, of the Congenital Heart Surgeons’ Society (CHSS) Data Center, and his coauthors. They reported their findings in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (153:163-72).
Norwood operations involve major surgical reconstruction along with exposure to cardiopulmonary bypass (CPB), with either deep hypothermic circulatory arrest (DHCA) or regional cerebral perfusion, during aortic arch reconstruction. Previous reports have linked CPB to postoperative hemodynamic instability, complications, and death (Ann Thorac Surg. 2009 Jun;87:1885-92). “In addition, the early physiological stress imposed on neonates after Norwood operations raises concerns regarding adverse neurodevelopment,” Dr. Wilder and his coauthors wrote.
Dr. Wilder and his coauthors pointed out that the hybrid procedure has emerged to avoid CPB and DHCA or regional cerebral perfusion and the potential resulting physiologic instability. “In this light, hybrid palliation may be perceived as a lower-risk alternative to Norwood operations, especially for patients considered at high risk for mortality,” the researchers said. Despite that perception, the actual survival “remains incompletely defined,” they said.
The overall average 4-year unadjusted survival for the entire study population was 65%, but those who had the NW-RVPA procedure had significantly improved survival (73%) vs. both the NW-BT (61%) and the hybrid groups (60%).
Those who had the hybrid procedure were older at stage 1 (12 days vs. 8 and 6 days, respectively for NW-BT and NW-RVPA) and had lower birth weight (2.9 kg vs. 3.2 kg and 3.15 kg, respectively). Hybrid patients also had a higher prevalence of baseline right ventricle dysfunction, were more likely to have baseline tricuspid valve regurgitation, and had a lower prevalence of aortic and mitral valve atresia.
For all patients, birth weight of 2.0-2.5 kg had a strong association with poor survival, Dr. Wilder and his coauthors reported, but the drop-off in survival for low-birth-weight neonates was greater in the Norwood group than in the hybrid group. “This finding suggests that hybrid procedures may offer a modest survival advantage over NW-RVPA at birth weight less than or equal to 2.0 kg and over NW-BT at birth weight less than or equal to 3.0 kg,” the researchers said.
Dr. Wilder and his coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Norwood procedures have the best survival rates for neonates with critical left ventricular outflow tract obstruction, but hybrid procedures may improve survival for those with lower birth weight.
Major finding: Risk-adjusted 4-year survival was 76% for the Norwood operation with a right ventricle–to-pulmonary artery conduit, 61% for Norwood with a modified Blalock-Taussig shunt and 60% for the hybrid procedure.
Data source: Prospective observational cohort study of 564 neonates admitted to 21 Congenital Heart Surgeons’ Society institutions from 2005 to 2014.
Disclosures: Dr. Wilder and his coauthors had no financial relationships to disclose.
Childhood PCV program produces overall protection
Childhood pneumococcal conjugate vaccines continue to indirectly produce widespread societal protection against invasive pneumococcal disease, a review and meta-analysis showed.
In fact, the reviewed studies suggest that the use of these vaccines in children can lead to an overall 90% drop in invasive pneumococcal disease within fewer than 10 years.
Herd immunity appears to be at work, the review authors said. The effect is so powerful that the findings raise questions about “the merit of offering [the 13-valent pneumococcal vaccine] in older groups” in places that have a children’s pneumococcal conjugate vaccine (PCV) program, the investigators said.
U.S. guidelines recommend vaccinations for older people, although the recommendations are up for review in 2018.
According to the review, childhood PCVs have had a tremendous impact since a seven-valent version (PCV7) was first released in 2000. “In vaccinated young children, disease due to serotypes included in the vaccines has been reduced to negligible levels,” the authors wrote.
But unvaccinated people, especially the elderly, remain susceptible.
The review authors, led by Tinevimbo Shiri, PhD, of the University of Warwick, Coventry, England, updated a 2013 systemic review (Vaccine. 2013 Dec 17;32[1]:133-45). They focused on studies from 1994 to 2016 that examined the effects of introducing PCV in children.
A total of 242 studies were included in the meta-analysis, published in the January issue of Lancet Global Health (2017 Jan;5[1]:e51-e9), including 70 from the previous review. Of these, only 9 (4%) were performed in poor or middle-income countries, with most of the rest having been done in North America (42%) and Europe (38%).
The researchers found that “[herd] immunity effects continued to accumulate over time and reduced disease due to PCV7 serotypes, for which follow-up data have generally been available for the longest period, with a 90% average reduction after about 9 years.”
Specifically, the review estimated it would take 8.9 years for a 90% reduction in invasive pneumococcal disease for grouped serotypes in the PCV7 and 9.5 years for the extra six grouped serotypes in the 13-valent PCV. The latter vaccine was introduced in 2010.
The researchers found evidence of a similar annual reduction in disease linked to grouped serotypes in the 23-valent pneumococcal polysaccharide vaccine in adults aged 19 and up. They noted that the 11 serotypes contained in PPV23 but not in PCV13 “did not change invasive pneumococcal disease at any age.”
The investigators added: “In countries with mature pediatric PCV programmes such as Canada, Germany, the Netherlands, the U.K., and the U.S.A., invasive pneumococcal disease due to PCV7 serotypes has been nearly eliminated through indirect protection - i.e., the average incidence of PCV7-invasive pneumococcal disease after nearly a decade of PCV7 use is less than 10 per 100,000 people. In these countries, consistent decreases in vaccine-type adult community-acquired pneumonia (CAP) or meningitis, and nonbacteraemic CAP, have been observed, indicating substantial indirect protection effects against noninvasive disease from childhood vaccination.”
The review authors noted that a major “evidence gap” in the effectiveness of childhood PCV programs in low-income countries exists. “Because these countries are increasingly undertaking childhood vaccination programs, research to assess the indirect effects in these settings is particularly relevant,” they wrote.
The review’s limitations include the possibility that the results could be thrown off by variations across nations in areas like diagnostic protocols, surveillance, and outcome measures.
The authors of the review, funded by the Policy Research Program of England’s Department of Health, reported no relevant financial disclosures.
The impact of pneumococcal conjugate vaccines has been hampered by serotypes that they don’t address, said David Goldblatt, PhD, MBChB, of the Great Ormond Street Institute of Child Health and University College London, in a commentary accompanying this review and meta-analysis (Lancet Glob Health. 2017 Jan;5[1]:e6-e7).
“Data from this meta-analysis have shown an overall reduction of invasive pneumococcal disease in all unvaccinated age groups of just 1%. … New extended-valency vaccines will be required to halt this erosion of PCV impact,” he wrote.
Dr. Goldblatt reported receiving grants and personal fees from GlaxoSmithKline, Merck, Sharpe, and Dohme and a publication with Pfizer.
The impact of pneumococcal conjugate vaccines has been hampered by serotypes that they don’t address, said David Goldblatt, PhD, MBChB, of the Great Ormond Street Institute of Child Health and University College London, in a commentary accompanying this review and meta-analysis (Lancet Glob Health. 2017 Jan;5[1]:e6-e7).
“Data from this meta-analysis have shown an overall reduction of invasive pneumococcal disease in all unvaccinated age groups of just 1%. … New extended-valency vaccines will be required to halt this erosion of PCV impact,” he wrote.
Dr. Goldblatt reported receiving grants and personal fees from GlaxoSmithKline, Merck, Sharpe, and Dohme and a publication with Pfizer.
The impact of pneumococcal conjugate vaccines has been hampered by serotypes that they don’t address, said David Goldblatt, PhD, MBChB, of the Great Ormond Street Institute of Child Health and University College London, in a commentary accompanying this review and meta-analysis (Lancet Glob Health. 2017 Jan;5[1]:e6-e7).
“Data from this meta-analysis have shown an overall reduction of invasive pneumococcal disease in all unvaccinated age groups of just 1%. … New extended-valency vaccines will be required to halt this erosion of PCV impact,” he wrote.
Dr. Goldblatt reported receiving grants and personal fees from GlaxoSmithKline, Merck, Sharpe, and Dohme and a publication with Pfizer.
Childhood pneumococcal conjugate vaccines continue to indirectly produce widespread societal protection against invasive pneumococcal disease, a review and meta-analysis showed.
In fact, the reviewed studies suggest that the use of these vaccines in children can lead to an overall 90% drop in invasive pneumococcal disease within fewer than 10 years.
Herd immunity appears to be at work, the review authors said. The effect is so powerful that the findings raise questions about “the merit of offering [the 13-valent pneumococcal vaccine] in older groups” in places that have a children’s pneumococcal conjugate vaccine (PCV) program, the investigators said.
U.S. guidelines recommend vaccinations for older people, although the recommendations are up for review in 2018.
According to the review, childhood PCVs have had a tremendous impact since a seven-valent version (PCV7) was first released in 2000. “In vaccinated young children, disease due to serotypes included in the vaccines has been reduced to negligible levels,” the authors wrote.
But unvaccinated people, especially the elderly, remain susceptible.
The review authors, led by Tinevimbo Shiri, PhD, of the University of Warwick, Coventry, England, updated a 2013 systemic review (Vaccine. 2013 Dec 17;32[1]:133-45). They focused on studies from 1994 to 2016 that examined the effects of introducing PCV in children.
A total of 242 studies were included in the meta-analysis, published in the January issue of Lancet Global Health (2017 Jan;5[1]:e51-e9), including 70 from the previous review. Of these, only 9 (4%) were performed in poor or middle-income countries, with most of the rest having been done in North America (42%) and Europe (38%).
The researchers found that “[herd] immunity effects continued to accumulate over time and reduced disease due to PCV7 serotypes, for which follow-up data have generally been available for the longest period, with a 90% average reduction after about 9 years.”
Specifically, the review estimated it would take 8.9 years for a 90% reduction in invasive pneumococcal disease for grouped serotypes in the PCV7 and 9.5 years for the extra six grouped serotypes in the 13-valent PCV. The latter vaccine was introduced in 2010.
The researchers found evidence of a similar annual reduction in disease linked to grouped serotypes in the 23-valent pneumococcal polysaccharide vaccine in adults aged 19 and up. They noted that the 11 serotypes contained in PPV23 but not in PCV13 “did not change invasive pneumococcal disease at any age.”
The investigators added: “In countries with mature pediatric PCV programmes such as Canada, Germany, the Netherlands, the U.K., and the U.S.A., invasive pneumococcal disease due to PCV7 serotypes has been nearly eliminated through indirect protection - i.e., the average incidence of PCV7-invasive pneumococcal disease after nearly a decade of PCV7 use is less than 10 per 100,000 people. In these countries, consistent decreases in vaccine-type adult community-acquired pneumonia (CAP) or meningitis, and nonbacteraemic CAP, have been observed, indicating substantial indirect protection effects against noninvasive disease from childhood vaccination.”
The review authors noted that a major “evidence gap” in the effectiveness of childhood PCV programs in low-income countries exists. “Because these countries are increasingly undertaking childhood vaccination programs, research to assess the indirect effects in these settings is particularly relevant,” they wrote.
The review’s limitations include the possibility that the results could be thrown off by variations across nations in areas like diagnostic protocols, surveillance, and outcome measures.
The authors of the review, funded by the Policy Research Program of England’s Department of Health, reported no relevant financial disclosures.
Childhood pneumococcal conjugate vaccines continue to indirectly produce widespread societal protection against invasive pneumococcal disease, a review and meta-analysis showed.
In fact, the reviewed studies suggest that the use of these vaccines in children can lead to an overall 90% drop in invasive pneumococcal disease within fewer than 10 years.
Herd immunity appears to be at work, the review authors said. The effect is so powerful that the findings raise questions about “the merit of offering [the 13-valent pneumococcal vaccine] in older groups” in places that have a children’s pneumococcal conjugate vaccine (PCV) program, the investigators said.
U.S. guidelines recommend vaccinations for older people, although the recommendations are up for review in 2018.
According to the review, childhood PCVs have had a tremendous impact since a seven-valent version (PCV7) was first released in 2000. “In vaccinated young children, disease due to serotypes included in the vaccines has been reduced to negligible levels,” the authors wrote.
But unvaccinated people, especially the elderly, remain susceptible.
The review authors, led by Tinevimbo Shiri, PhD, of the University of Warwick, Coventry, England, updated a 2013 systemic review (Vaccine. 2013 Dec 17;32[1]:133-45). They focused on studies from 1994 to 2016 that examined the effects of introducing PCV in children.
A total of 242 studies were included in the meta-analysis, published in the January issue of Lancet Global Health (2017 Jan;5[1]:e51-e9), including 70 from the previous review. Of these, only 9 (4%) were performed in poor or middle-income countries, with most of the rest having been done in North America (42%) and Europe (38%).
The researchers found that “[herd] immunity effects continued to accumulate over time and reduced disease due to PCV7 serotypes, for which follow-up data have generally been available for the longest period, with a 90% average reduction after about 9 years.”
Specifically, the review estimated it would take 8.9 years for a 90% reduction in invasive pneumococcal disease for grouped serotypes in the PCV7 and 9.5 years for the extra six grouped serotypes in the 13-valent PCV. The latter vaccine was introduced in 2010.
The researchers found evidence of a similar annual reduction in disease linked to grouped serotypes in the 23-valent pneumococcal polysaccharide vaccine in adults aged 19 and up. They noted that the 11 serotypes contained in PPV23 but not in PCV13 “did not change invasive pneumococcal disease at any age.”
The investigators added: “In countries with mature pediatric PCV programmes such as Canada, Germany, the Netherlands, the U.K., and the U.S.A., invasive pneumococcal disease due to PCV7 serotypes has been nearly eliminated through indirect protection - i.e., the average incidence of PCV7-invasive pneumococcal disease after nearly a decade of PCV7 use is less than 10 per 100,000 people. In these countries, consistent decreases in vaccine-type adult community-acquired pneumonia (CAP) or meningitis, and nonbacteraemic CAP, have been observed, indicating substantial indirect protection effects against noninvasive disease from childhood vaccination.”
The review authors noted that a major “evidence gap” in the effectiveness of childhood PCV programs in low-income countries exists. “Because these countries are increasingly undertaking childhood vaccination programs, research to assess the indirect effects in these settings is particularly relevant,” they wrote.
The review’s limitations include the possibility that the results could be thrown off by variations across nations in areas like diagnostic protocols, surveillance, and outcome measures.
The authors of the review, funded by the Policy Research Program of England’s Department of Health, reported no relevant financial disclosures.
FROM THE LANCET GLOBAL HEALTH
Key clinical point: Through apparent herd immunity, childhood pneumococcal conjugate vaccines produce societywide reductions in invasive pneumococcal disease in less than a decade.
Major finding: When a seven-valent PCV is given to children, it would take an estimated 8.9 years for a 90% reduction in invasive pneumococcal disease to be seen among the grouped serotypes. It would take an estimated 9.5 years for an identical reduction in the extra six grouped serotypes in the 13-valent PCV.
Data source: A review and meta-analysis of 242 studies from 1994 to 2016 that examined the effects of introducing PCVs in children.
Disclosures: The review authors reported no relevant financial disclosures.
Double-dose influenza vaccine effective against type B strains
A double-dose inactivated quadrivalent influenza vaccine (IIV4) could be administered to all children aged 6-35 months, as it not only offers the best protection against influenza type B, but it also allows for simplifying the current vaccination schedule considerably.
“The introduction of IIV4 provides an opportunity to review long-accepted practices in administration of influenza vaccines,” explained Varsha K. Jain, MD, formerly employed by GlaxoSmithKline Vaccines, King of Prussia, Pa., and associates.
Giving a lower dose to young children was planned to reduce reactogenicity and febrile convulsions observed with the whole virus vaccines that were in use in the 1970s. But young children have a variable immune response to lower doses, especially against vaccine B strains, they noted (J Ped Infect Dis. 2017 Jan 6. doi: 10.1093/jpids/piw068).
Dr. Jain and coauthors enrolled 2,430 children aged 6-35 months during the 2014-2015 influenza season in the United States and Mexico in this phase III study. Children were randomized into one of two cohorts: one cohort received a standard-doze IIV4 vaccination, while the other received a double-dose. Data on age (6-17 months, 18-35 months), health care center, and influenza primer status also were taken into consideration.
The standard-dose vaccine contained 7.5 mcg of A/California/7/2009 (A/H1N1), A/Texas/50/2012 (A/H3N2), B/Brisbane/60/2008 (B/Victoria), and B/Massachusetts/2/2012 (B/Yamagata), while the double-dose vaccine contained 15 mcg, or twice the amount each, of the same strains. The former was developed by Sanofi Pasteur and the latter by GSK Vaccines.
Primed children who completed the study numbered 1,173; 586 received the standard-dose and 587 received the double-dose. On the unprimed side, 868 completed the study: 442 standard-dose and 426 double-dose. Each dose’s immunogenic noninferiority was quantified by calculating the geometric mean titer (GMT) ratio.
“Immunogenicity was higher in the double-dose group compared with the standard-dose group, particularly against vaccine B strains in children 6-17 months of age and unprimed children,” Dr. Vain and associates said. Both vaccines performed well against the influenza B strain, with the double-dose yielding a GMT of 1.89 against the B/Yamagata strain and 2.13 against the B/Victoria in children aged 6-17 months. Across the entire age spectrum of the study population, unprimed children registered a GMT of 1.85 and 2.04 against the same strains, respectively. For comparison, none of the A strains in any cohort based on age or primed/unprimed registered a GMT above 1.5.
“Increased protection against influenza B [would] be a beneficial clinical outcome [and] use of the same vaccine dose for all eligible ages would also simplify the annual influenza vaccine campaign and reduce cost and logistic complexity,” the authors concluded. “This study provides evidence to support a change in clinical practice to use [double-dose IIV4] in all children 6 months of age and older, once that dosing for a vaccine product has been approved.”
Dr. Jain now is employed by the Bill and Melinda Gates Foundation.
Dr. Jain and several coauthors disclosed ties to GlaxoSmithKline, which funded the study.
A double-dose inactivated quadrivalent influenza vaccine (IIV4) could be administered to all children aged 6-35 months, as it not only offers the best protection against influenza type B, but it also allows for simplifying the current vaccination schedule considerably.
“The introduction of IIV4 provides an opportunity to review long-accepted practices in administration of influenza vaccines,” explained Varsha K. Jain, MD, formerly employed by GlaxoSmithKline Vaccines, King of Prussia, Pa., and associates.
Giving a lower dose to young children was planned to reduce reactogenicity and febrile convulsions observed with the whole virus vaccines that were in use in the 1970s. But young children have a variable immune response to lower doses, especially against vaccine B strains, they noted (J Ped Infect Dis. 2017 Jan 6. doi: 10.1093/jpids/piw068).
Dr. Jain and coauthors enrolled 2,430 children aged 6-35 months during the 2014-2015 influenza season in the United States and Mexico in this phase III study. Children were randomized into one of two cohorts: one cohort received a standard-doze IIV4 vaccination, while the other received a double-dose. Data on age (6-17 months, 18-35 months), health care center, and influenza primer status also were taken into consideration.
The standard-dose vaccine contained 7.5 mcg of A/California/7/2009 (A/H1N1), A/Texas/50/2012 (A/H3N2), B/Brisbane/60/2008 (B/Victoria), and B/Massachusetts/2/2012 (B/Yamagata), while the double-dose vaccine contained 15 mcg, or twice the amount each, of the same strains. The former was developed by Sanofi Pasteur and the latter by GSK Vaccines.
Primed children who completed the study numbered 1,173; 586 received the standard-dose and 587 received the double-dose. On the unprimed side, 868 completed the study: 442 standard-dose and 426 double-dose. Each dose’s immunogenic noninferiority was quantified by calculating the geometric mean titer (GMT) ratio.
“Immunogenicity was higher in the double-dose group compared with the standard-dose group, particularly against vaccine B strains in children 6-17 months of age and unprimed children,” Dr. Vain and associates said. Both vaccines performed well against the influenza B strain, with the double-dose yielding a GMT of 1.89 against the B/Yamagata strain and 2.13 against the B/Victoria in children aged 6-17 months. Across the entire age spectrum of the study population, unprimed children registered a GMT of 1.85 and 2.04 against the same strains, respectively. For comparison, none of the A strains in any cohort based on age or primed/unprimed registered a GMT above 1.5.
“Increased protection against influenza B [would] be a beneficial clinical outcome [and] use of the same vaccine dose for all eligible ages would also simplify the annual influenza vaccine campaign and reduce cost and logistic complexity,” the authors concluded. “This study provides evidence to support a change in clinical practice to use [double-dose IIV4] in all children 6 months of age and older, once that dosing for a vaccine product has been approved.”
Dr. Jain now is employed by the Bill and Melinda Gates Foundation.
Dr. Jain and several coauthors disclosed ties to GlaxoSmithKline, which funded the study.
A double-dose inactivated quadrivalent influenza vaccine (IIV4) could be administered to all children aged 6-35 months, as it not only offers the best protection against influenza type B, but it also allows for simplifying the current vaccination schedule considerably.
“The introduction of IIV4 provides an opportunity to review long-accepted practices in administration of influenza vaccines,” explained Varsha K. Jain, MD, formerly employed by GlaxoSmithKline Vaccines, King of Prussia, Pa., and associates.
Giving a lower dose to young children was planned to reduce reactogenicity and febrile convulsions observed with the whole virus vaccines that were in use in the 1970s. But young children have a variable immune response to lower doses, especially against vaccine B strains, they noted (J Ped Infect Dis. 2017 Jan 6. doi: 10.1093/jpids/piw068).
Dr. Jain and coauthors enrolled 2,430 children aged 6-35 months during the 2014-2015 influenza season in the United States and Mexico in this phase III study. Children were randomized into one of two cohorts: one cohort received a standard-doze IIV4 vaccination, while the other received a double-dose. Data on age (6-17 months, 18-35 months), health care center, and influenza primer status also were taken into consideration.
The standard-dose vaccine contained 7.5 mcg of A/California/7/2009 (A/H1N1), A/Texas/50/2012 (A/H3N2), B/Brisbane/60/2008 (B/Victoria), and B/Massachusetts/2/2012 (B/Yamagata), while the double-dose vaccine contained 15 mcg, or twice the amount each, of the same strains. The former was developed by Sanofi Pasteur and the latter by GSK Vaccines.
Primed children who completed the study numbered 1,173; 586 received the standard-dose and 587 received the double-dose. On the unprimed side, 868 completed the study: 442 standard-dose and 426 double-dose. Each dose’s immunogenic noninferiority was quantified by calculating the geometric mean titer (GMT) ratio.
“Immunogenicity was higher in the double-dose group compared with the standard-dose group, particularly against vaccine B strains in children 6-17 months of age and unprimed children,” Dr. Vain and associates said. Both vaccines performed well against the influenza B strain, with the double-dose yielding a GMT of 1.89 against the B/Yamagata strain and 2.13 against the B/Victoria in children aged 6-17 months. Across the entire age spectrum of the study population, unprimed children registered a GMT of 1.85 and 2.04 against the same strains, respectively. For comparison, none of the A strains in any cohort based on age or primed/unprimed registered a GMT above 1.5.
“Increased protection against influenza B [would] be a beneficial clinical outcome [and] use of the same vaccine dose for all eligible ages would also simplify the annual influenza vaccine campaign and reduce cost and logistic complexity,” the authors concluded. “This study provides evidence to support a change in clinical practice to use [double-dose IIV4] in all children 6 months of age and older, once that dosing for a vaccine product has been approved.”
Dr. Jain now is employed by the Bill and Melinda Gates Foundation.
Dr. Jain and several coauthors disclosed ties to GlaxoSmithKline, which funded the study.
FROM THE JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY
Key clinical point:
Major finding: Geometric mean titer (GMT) ratios showed that the double-dose IIV4 vaccine was the most effective against influenza type B in children aged 6-17 months (GMT = 1.89) and in unprimed children aged 6-35 months (GMT = 1.85).
Data source: Phase III, randomized trial of 2,041 children aged 6-35 months.
Disclosures: Dr. Jain and several coauthors disclosed ties to GlaxoSmithKline, which funded the study.
Discussing the ADHD ‘controversy’ with patients and parents
There are many topics within the child psychiatry community that are controversial. How many kids really deserve a diagnosis of bipolar disorder? Which type of therapy works best? Is cannabis a gateway drug? The existence of attention-deficit/hyperactivity disorder as a legitimate psychiatric entity, however, is not one of them.
Despite this fact, there remains considerable controversy in the public about how “real” ADHD actually is. Social media, blogs, and even entire books have been written that disparage the diagnosis and even suggest that ADHD was fabricated by the pharmaceutical industry to sell medications. Although these publications and posts generally ignore the scientific literature or at least twist it beyond recognition, there are several aspects of ADHD that legitimately cause more confusion and less confidence about the diagnosis, relative to other common pediatric problems. This column attempts to describe and contextualize these elements so that pediatricians can be more fully informed when they are called to respond to some of the allegations against ADHD that often are brought up by families.
Case summary
Hunter is a 6-year-old boy who presents with his mother and father for “behavioral concerns.” He always has been an energetic child, but the school has been having increasing difficulties with his behavior. Hunter struggles to stay in his seat and take part in quiet activities. His teacher needs to give multiple reminders per day about not interrupting others or speaking out in class. Without redirection, Hunter typically loses focus in class and does not complete his work. Because of these difficulties, the question of ADHD arose during a recent parent-teacher conference. While Hunter’s mother acknowledges these behaviors and notes similar ones at home, the father is resisting any further evaluation, claiming that Hunter “is just being a boy.” The father notes that he acted similarly as a child and “turned out okay.” When the mother tried to research ADHD online, she encountered several sites that claimed that the diagnosis of ADHD was “made up” by drug companies wanting “to turn kids into zombies.” At the appointment, the parents state that they want their son to succeed and be happy, but are concerned about some of the things they have read on the Internet.
Discussion
This example represents a common dilemma for parents who encounter so many mixed messages when doing background research on ADHD. Although the legitimacy of ADHD has been supported in literally hundreds of research studies that have examined areas such as genetics, neuropsychological testing, and brain imaging1,2, some of the lingering doubts about ADHD validity are rooted in characteristics of the diagnosis that do differ from some nonpsychiatric diagnoses. At the same time, however, further inspection reveals that these qualities exist for many other entities that have received far less public criticism. Three of these main qualities include the following:
1. ADHD is a dimensional rather than binary entity. Despite the fact that the current nomenclature continues to frame ADHD as an all-or-nothing diagnosis, there is now overwhelming scientific evidence that it is much more accurately conceptualized as a dimension3. As such, there is no clear-cut boundary between what should be judged as “typical” levels of attention and activity and ADHD. As written in a previous column4, in some ways the label of ADHD is a lot like the label of someone being tall, with some individuals clearly falling into the category of “tall” or “not tall,” while many others could be considered in-between. However, many of the most common nonpsychiatric conditions such as hypertension and hypercholesterolemia also exist this way without high levels of public controversy.
2. ADHD lacks a specific known neurobiologic marker that can be measured by a lab or neuroimaging test. As mentioned, there is a vast literature supporting the idea that the brains of people with ADHD are different from those without ADHD, but these differences tend to describe quantitative differences in regional brain volume, cortical thickness, activity levels, or connectivity rather than a discrete “thing” that a radiologist can point to on a scan. Given the dimensional nature of ADHD and the broad brain processes required for complex functions such as attention and motor activity, the lack of a specific and universal “lesion” underlying ADHD is to be expected, yet it still remains easy ammunition for those who criticize the diagnosis. Again, very similar cases can be made for other entities such as autism or low intelligence, which few argue are not real but also have no reliable biomarker to support them.
3. Medications often are used to treat ADHD. The diagnosis of ADHD would probably be far less controversial if one of its primary treatments did not involve psychiatric medications. While it is probably fair to say that the many nonpharmacologic approaches to ADHD are quite underutilized, it seems a stretch to use potential overreliance on medication as a legitimate reason to question the validity of a diagnosis. Opiate abuse also is a problem in this country, but that doesn’t mean a person’s pain doesn’t exist. As a practical tip, it can be reassuring for families to hear explicitly from their physician that “zombification” is not considered an acceptable medical outcome and that the prescribing clinician will promptly deal with any side effects that might occur with treatment5.
Understanding these aspects about ADHD and how they are misinterpreted in the media can help families make more informed and comfortable decisions about their child’s care in collaboration with their pediatrician. It also is important for pediatricians to be proactive in distributing reliable and science-backed material to the public in this new age of information overload.
Case follow-up
The pediatrician hears the family’s concerns and discusses the evidence supporting the scientific legitimacy of ADHD, as well as some of the qualities of the diagnosis that have led to its controversy. The parents are reassured but would like to proceed carefully and cautiously with further work-up and treatment. The pediatrician sends the family home with some quantitative rating scales to be completed by Hunter’s parents and teacher. She also makes a plan to begin monitoring several health promotion areas that could be impacting Hunter’s behavior including sleep quality, physical activity, screen time, and nutrition.
References
1. Psychiatr Clin North Am. 2010 Mar;33(1):159-80.
2. Dev Neuropsychol. 2013;38(4):211-25.3. Can Fam Physician. 2016 Dec;62(12):979-82.
4. ADHD boundaries with normal behavior. Pediatric News; published online Aug. 27, 2014.
5. Zombification is not an acceptable medical outcome. Psychology Today, ABCs of Child Psychiatry blog; published online Oct. 18, 2013.
Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych.
There are many topics within the child psychiatry community that are controversial. How many kids really deserve a diagnosis of bipolar disorder? Which type of therapy works best? Is cannabis a gateway drug? The existence of attention-deficit/hyperactivity disorder as a legitimate psychiatric entity, however, is not one of them.
Despite this fact, there remains considerable controversy in the public about how “real” ADHD actually is. Social media, blogs, and even entire books have been written that disparage the diagnosis and even suggest that ADHD was fabricated by the pharmaceutical industry to sell medications. Although these publications and posts generally ignore the scientific literature or at least twist it beyond recognition, there are several aspects of ADHD that legitimately cause more confusion and less confidence about the diagnosis, relative to other common pediatric problems. This column attempts to describe and contextualize these elements so that pediatricians can be more fully informed when they are called to respond to some of the allegations against ADHD that often are brought up by families.
Case summary
Hunter is a 6-year-old boy who presents with his mother and father for “behavioral concerns.” He always has been an energetic child, but the school has been having increasing difficulties with his behavior. Hunter struggles to stay in his seat and take part in quiet activities. His teacher needs to give multiple reminders per day about not interrupting others or speaking out in class. Without redirection, Hunter typically loses focus in class and does not complete his work. Because of these difficulties, the question of ADHD arose during a recent parent-teacher conference. While Hunter’s mother acknowledges these behaviors and notes similar ones at home, the father is resisting any further evaluation, claiming that Hunter “is just being a boy.” The father notes that he acted similarly as a child and “turned out okay.” When the mother tried to research ADHD online, she encountered several sites that claimed that the diagnosis of ADHD was “made up” by drug companies wanting “to turn kids into zombies.” At the appointment, the parents state that they want their son to succeed and be happy, but are concerned about some of the things they have read on the Internet.
Discussion
This example represents a common dilemma for parents who encounter so many mixed messages when doing background research on ADHD. Although the legitimacy of ADHD has been supported in literally hundreds of research studies that have examined areas such as genetics, neuropsychological testing, and brain imaging1,2, some of the lingering doubts about ADHD validity are rooted in characteristics of the diagnosis that do differ from some nonpsychiatric diagnoses. At the same time, however, further inspection reveals that these qualities exist for many other entities that have received far less public criticism. Three of these main qualities include the following:
1. ADHD is a dimensional rather than binary entity. Despite the fact that the current nomenclature continues to frame ADHD as an all-or-nothing diagnosis, there is now overwhelming scientific evidence that it is much more accurately conceptualized as a dimension3. As such, there is no clear-cut boundary between what should be judged as “typical” levels of attention and activity and ADHD. As written in a previous column4, in some ways the label of ADHD is a lot like the label of someone being tall, with some individuals clearly falling into the category of “tall” or “not tall,” while many others could be considered in-between. However, many of the most common nonpsychiatric conditions such as hypertension and hypercholesterolemia also exist this way without high levels of public controversy.
2. ADHD lacks a specific known neurobiologic marker that can be measured by a lab or neuroimaging test. As mentioned, there is a vast literature supporting the idea that the brains of people with ADHD are different from those without ADHD, but these differences tend to describe quantitative differences in regional brain volume, cortical thickness, activity levels, or connectivity rather than a discrete “thing” that a radiologist can point to on a scan. Given the dimensional nature of ADHD and the broad brain processes required for complex functions such as attention and motor activity, the lack of a specific and universal “lesion” underlying ADHD is to be expected, yet it still remains easy ammunition for those who criticize the diagnosis. Again, very similar cases can be made for other entities such as autism or low intelligence, which few argue are not real but also have no reliable biomarker to support them.
3. Medications often are used to treat ADHD. The diagnosis of ADHD would probably be far less controversial if one of its primary treatments did not involve psychiatric medications. While it is probably fair to say that the many nonpharmacologic approaches to ADHD are quite underutilized, it seems a stretch to use potential overreliance on medication as a legitimate reason to question the validity of a diagnosis. Opiate abuse also is a problem in this country, but that doesn’t mean a person’s pain doesn’t exist. As a practical tip, it can be reassuring for families to hear explicitly from their physician that “zombification” is not considered an acceptable medical outcome and that the prescribing clinician will promptly deal with any side effects that might occur with treatment5.
Understanding these aspects about ADHD and how they are misinterpreted in the media can help families make more informed and comfortable decisions about their child’s care in collaboration with their pediatrician. It also is important for pediatricians to be proactive in distributing reliable and science-backed material to the public in this new age of information overload.
Case follow-up
The pediatrician hears the family’s concerns and discusses the evidence supporting the scientific legitimacy of ADHD, as well as some of the qualities of the diagnosis that have led to its controversy. The parents are reassured but would like to proceed carefully and cautiously with further work-up and treatment. The pediatrician sends the family home with some quantitative rating scales to be completed by Hunter’s parents and teacher. She also makes a plan to begin monitoring several health promotion areas that could be impacting Hunter’s behavior including sleep quality, physical activity, screen time, and nutrition.
References
1. Psychiatr Clin North Am. 2010 Mar;33(1):159-80.
2. Dev Neuropsychol. 2013;38(4):211-25.3. Can Fam Physician. 2016 Dec;62(12):979-82.
4. ADHD boundaries with normal behavior. Pediatric News; published online Aug. 27, 2014.
5. Zombification is not an acceptable medical outcome. Psychology Today, ABCs of Child Psychiatry blog; published online Oct. 18, 2013.
Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych.
There are many topics within the child psychiatry community that are controversial. How many kids really deserve a diagnosis of bipolar disorder? Which type of therapy works best? Is cannabis a gateway drug? The existence of attention-deficit/hyperactivity disorder as a legitimate psychiatric entity, however, is not one of them.
Despite this fact, there remains considerable controversy in the public about how “real” ADHD actually is. Social media, blogs, and even entire books have been written that disparage the diagnosis and even suggest that ADHD was fabricated by the pharmaceutical industry to sell medications. Although these publications and posts generally ignore the scientific literature or at least twist it beyond recognition, there are several aspects of ADHD that legitimately cause more confusion and less confidence about the diagnosis, relative to other common pediatric problems. This column attempts to describe and contextualize these elements so that pediatricians can be more fully informed when they are called to respond to some of the allegations against ADHD that often are brought up by families.
Case summary
Hunter is a 6-year-old boy who presents with his mother and father for “behavioral concerns.” He always has been an energetic child, but the school has been having increasing difficulties with his behavior. Hunter struggles to stay in his seat and take part in quiet activities. His teacher needs to give multiple reminders per day about not interrupting others or speaking out in class. Without redirection, Hunter typically loses focus in class and does not complete his work. Because of these difficulties, the question of ADHD arose during a recent parent-teacher conference. While Hunter’s mother acknowledges these behaviors and notes similar ones at home, the father is resisting any further evaluation, claiming that Hunter “is just being a boy.” The father notes that he acted similarly as a child and “turned out okay.” When the mother tried to research ADHD online, she encountered several sites that claimed that the diagnosis of ADHD was “made up” by drug companies wanting “to turn kids into zombies.” At the appointment, the parents state that they want their son to succeed and be happy, but are concerned about some of the things they have read on the Internet.
Discussion
This example represents a common dilemma for parents who encounter so many mixed messages when doing background research on ADHD. Although the legitimacy of ADHD has been supported in literally hundreds of research studies that have examined areas such as genetics, neuropsychological testing, and brain imaging1,2, some of the lingering doubts about ADHD validity are rooted in characteristics of the diagnosis that do differ from some nonpsychiatric diagnoses. At the same time, however, further inspection reveals that these qualities exist for many other entities that have received far less public criticism. Three of these main qualities include the following:
1. ADHD is a dimensional rather than binary entity. Despite the fact that the current nomenclature continues to frame ADHD as an all-or-nothing diagnosis, there is now overwhelming scientific evidence that it is much more accurately conceptualized as a dimension3. As such, there is no clear-cut boundary between what should be judged as “typical” levels of attention and activity and ADHD. As written in a previous column4, in some ways the label of ADHD is a lot like the label of someone being tall, with some individuals clearly falling into the category of “tall” or “not tall,” while many others could be considered in-between. However, many of the most common nonpsychiatric conditions such as hypertension and hypercholesterolemia also exist this way without high levels of public controversy.
2. ADHD lacks a specific known neurobiologic marker that can be measured by a lab or neuroimaging test. As mentioned, there is a vast literature supporting the idea that the brains of people with ADHD are different from those without ADHD, but these differences tend to describe quantitative differences in regional brain volume, cortical thickness, activity levels, or connectivity rather than a discrete “thing” that a radiologist can point to on a scan. Given the dimensional nature of ADHD and the broad brain processes required for complex functions such as attention and motor activity, the lack of a specific and universal “lesion” underlying ADHD is to be expected, yet it still remains easy ammunition for those who criticize the diagnosis. Again, very similar cases can be made for other entities such as autism or low intelligence, which few argue are not real but also have no reliable biomarker to support them.
3. Medications often are used to treat ADHD. The diagnosis of ADHD would probably be far less controversial if one of its primary treatments did not involve psychiatric medications. While it is probably fair to say that the many nonpharmacologic approaches to ADHD are quite underutilized, it seems a stretch to use potential overreliance on medication as a legitimate reason to question the validity of a diagnosis. Opiate abuse also is a problem in this country, but that doesn’t mean a person’s pain doesn’t exist. As a practical tip, it can be reassuring for families to hear explicitly from their physician that “zombification” is not considered an acceptable medical outcome and that the prescribing clinician will promptly deal with any side effects that might occur with treatment5.
Understanding these aspects about ADHD and how they are misinterpreted in the media can help families make more informed and comfortable decisions about their child’s care in collaboration with their pediatrician. It also is important for pediatricians to be proactive in distributing reliable and science-backed material to the public in this new age of information overload.
Case follow-up
The pediatrician hears the family’s concerns and discusses the evidence supporting the scientific legitimacy of ADHD, as well as some of the qualities of the diagnosis that have led to its controversy. The parents are reassured but would like to proceed carefully and cautiously with further work-up and treatment. The pediatrician sends the family home with some quantitative rating scales to be completed by Hunter’s parents and teacher. She also makes a plan to begin monitoring several health promotion areas that could be impacting Hunter’s behavior including sleep quality, physical activity, screen time, and nutrition.
References
1. Psychiatr Clin North Am. 2010 Mar;33(1):159-80.
2. Dev Neuropsychol. 2013;38(4):211-25.3. Can Fam Physician. 2016 Dec;62(12):979-82.
4. ADHD boundaries with normal behavior. Pediatric News; published online Aug. 27, 2014.
5. Zombification is not an acceptable medical outcome. Psychology Today, ABCs of Child Psychiatry blog; published online Oct. 18, 2013.
Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych.
‘And a child shall lead them’
With a moistened index finger pointing skyward, I always have tried to remain alert to where the winds of change are blowing. But every now and then I miss a trend in child care, and that is the case with something known as “baby-led weaning.” Influenced by the questionable notion that there is a “natural” way of doing almost everything, the concept hinges on the belief that an infant will “tell” his mother when it is time to stop nursing and begin solids, aka complementary feeding.
At face value, the concept of allowing the baby to lead is a good one simply because of universality of biologic variation. Just as with the question of how much sleep a baby needs, I don’t think anyone (let alone clinicians) can give with assurance an answer that can easily be applied to all infants. There are just too many variables.
For most dyads, breastfeeding is more than just passing calories from one individual to another. Nursing can offer a sense of security and calming both for infants and their mothers. In many cases, the breast unfortunately has become a critical ingredient in the infant’s ritual for falling to sleep. For some mothers, success at breastfeeding becomes an important validation of her feelings of confidence and self-worth that in the past may have been battered by a male-dominated environment. If breastfeeding has been an unpleasant experience, a mother may be more likely to interpret her infant’s behavior as a message that it is time to wean. The bottom line is that a mother’s perception of her baby’s messages about weaning often reflects her own feelings about nursing.
Of course, we clinicians can influence a mother’s perception of her baby’s messages by introducing our own biases about what we believe is the safest, most nutritionally sound way to introduce complementary feeding. And let’s be honest and acknowledge that those are biases mostly unsupported by good scientific study. In many cases, they are more of a reflection of the cultures in which we have grown up.
When asked by parents how they will know when their infant is ready for complementary feeding, I suggest that it’s time when the infant is not only curious about what the adults around him are eating, but obviously is upset that he isn’t being offered a taste. I add that exactly what that food should be is a matter of debate and common sense.
I also encourage parents to allow the child to do as much self-feeding as possible and not worry about the mess. An old shower curtain floor and plenty of sponges and paper towels are a must.
In most cases, I think we can trust babies to take the lead in weaning. But I also believe that as clinicians we must remain alert to the few situations when extended nursing is not in the best interest for the baby who is not growing well or for the mother for whom the nursing is taking an unreasonable toll on her physical and mental health.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.
With a moistened index finger pointing skyward, I always have tried to remain alert to where the winds of change are blowing. But every now and then I miss a trend in child care, and that is the case with something known as “baby-led weaning.” Influenced by the questionable notion that there is a “natural” way of doing almost everything, the concept hinges on the belief that an infant will “tell” his mother when it is time to stop nursing and begin solids, aka complementary feeding.
At face value, the concept of allowing the baby to lead is a good one simply because of universality of biologic variation. Just as with the question of how much sleep a baby needs, I don’t think anyone (let alone clinicians) can give with assurance an answer that can easily be applied to all infants. There are just too many variables.
For most dyads, breastfeeding is more than just passing calories from one individual to another. Nursing can offer a sense of security and calming both for infants and their mothers. In many cases, the breast unfortunately has become a critical ingredient in the infant’s ritual for falling to sleep. For some mothers, success at breastfeeding becomes an important validation of her feelings of confidence and self-worth that in the past may have been battered by a male-dominated environment. If breastfeeding has been an unpleasant experience, a mother may be more likely to interpret her infant’s behavior as a message that it is time to wean. The bottom line is that a mother’s perception of her baby’s messages about weaning often reflects her own feelings about nursing.
Of course, we clinicians can influence a mother’s perception of her baby’s messages by introducing our own biases about what we believe is the safest, most nutritionally sound way to introduce complementary feeding. And let’s be honest and acknowledge that those are biases mostly unsupported by good scientific study. In many cases, they are more of a reflection of the cultures in which we have grown up.
When asked by parents how they will know when their infant is ready for complementary feeding, I suggest that it’s time when the infant is not only curious about what the adults around him are eating, but obviously is upset that he isn’t being offered a taste. I add that exactly what that food should be is a matter of debate and common sense.
I also encourage parents to allow the child to do as much self-feeding as possible and not worry about the mess. An old shower curtain floor and plenty of sponges and paper towels are a must.
In most cases, I think we can trust babies to take the lead in weaning. But I also believe that as clinicians we must remain alert to the few situations when extended nursing is not in the best interest for the baby who is not growing well or for the mother for whom the nursing is taking an unreasonable toll on her physical and mental health.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.
With a moistened index finger pointing skyward, I always have tried to remain alert to where the winds of change are blowing. But every now and then I miss a trend in child care, and that is the case with something known as “baby-led weaning.” Influenced by the questionable notion that there is a “natural” way of doing almost everything, the concept hinges on the belief that an infant will “tell” his mother when it is time to stop nursing and begin solids, aka complementary feeding.
At face value, the concept of allowing the baby to lead is a good one simply because of universality of biologic variation. Just as with the question of how much sleep a baby needs, I don’t think anyone (let alone clinicians) can give with assurance an answer that can easily be applied to all infants. There are just too many variables.
For most dyads, breastfeeding is more than just passing calories from one individual to another. Nursing can offer a sense of security and calming both for infants and their mothers. In many cases, the breast unfortunately has become a critical ingredient in the infant’s ritual for falling to sleep. For some mothers, success at breastfeeding becomes an important validation of her feelings of confidence and self-worth that in the past may have been battered by a male-dominated environment. If breastfeeding has been an unpleasant experience, a mother may be more likely to interpret her infant’s behavior as a message that it is time to wean. The bottom line is that a mother’s perception of her baby’s messages about weaning often reflects her own feelings about nursing.
Of course, we clinicians can influence a mother’s perception of her baby’s messages by introducing our own biases about what we believe is the safest, most nutritionally sound way to introduce complementary feeding. And let’s be honest and acknowledge that those are biases mostly unsupported by good scientific study. In many cases, they are more of a reflection of the cultures in which we have grown up.
When asked by parents how they will know when their infant is ready for complementary feeding, I suggest that it’s time when the infant is not only curious about what the adults around him are eating, but obviously is upset that he isn’t being offered a taste. I add that exactly what that food should be is a matter of debate and common sense.
I also encourage parents to allow the child to do as much self-feeding as possible and not worry about the mess. An old shower curtain floor and plenty of sponges and paper towels are a must.
In most cases, I think we can trust babies to take the lead in weaning. But I also believe that as clinicians we must remain alert to the few situations when extended nursing is not in the best interest for the baby who is not growing well or for the mother for whom the nursing is taking an unreasonable toll on her physical and mental health.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.