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The Official Newspaper of the American Association for Thoracic Surgery
Age and disease stage predict long-term survival in elderly lung cancer patients
AT THE STS ANNUAL MEETING
HOUSTON – Although certain medical factors predict long-term survival in patients over age 65 years with lung cancer, advanced age and disease stage are especially strong predictors, results from a large analysis of national data demonstrated.
The findings, which were presented by Mark Onaitis, MD, at the annual meeting of the Society of Thoracic Surgeons, come from a novel effort to pair Medicare data with files from the STS General Thoracic Surgery Database (GTSD).
For the current study, he and his associates linked GTSD data to Medicare data on 29,899 patients who underwent lung cancer resection from 2002 to 2013. They used Cox proportional hazards modeling to create a long-term survival model and used statistically significant univariate factors and known clinical predictors of outcome to perform variable selection.
Dr. Onaitis reported that the median age of patients was 73 years and that 52% were female. Of the 29,899 patients, 805 had a missing pathologic stage. Of the 29,094 patients not missing a pathologic stage, 69% were stage I, 18% stage II, 11% stage III, and 2% stage IV. Two-thirds of patients (66%) underwent lobectomy, followed by wedge resection (17%), segmentectomy (7%), bilobectomy (3%), pneumonectomy (3%), and sleeve lobectomy (1%). A thoracoscopic approach was performed in nearly half of resections (47%).
Cox analysis revealed the following strong negative predictors of long-term survival: having stage III or IV-V disease (hazard ratio, 1.23 and 1.37, respectively), being age 70-74 (HR, 1.19), 75-80 (HR, 1.40), or 80 and older (HR, 1.90).
After controlling for disease stage, the following procedures were associated with increased hazard of death, compared with lobectomy: wedge resection (HR, 1.22), segmentectomy (HR, 1.10), bilobectomy (HR, 1.30), and pneumonectomy (HR, 1.58). In addition, video-assisted thoracoscopic surgery was associated with improved long-term survival, compared with thoracotomy (HR, 0.86).
“Given the large number of patients and the excellent quality of the data, it was not surprising that age and stage and known medical conditions affect long-term survival,” Dr. Onaitis commented. “The deleterious effects of sublobar operations and open [as opposed to thoracoscopic or VATS] approach were more pronounced than expected.”
Other modifiable predictive factors include being a past or current smoker (HR, 1.35 and HR, 1.54, respectively) and having a body mass index below 18.5 kg/m2 (HR, 1.58).
Dr. Onaitis acknowledged certain limitations of the study, including its retrospective design. “Because the study involves linkage of STS data to Medicare data, the findings may not be applicable to patients less than 65 years of age,” he added. He reported having no financial disclosures.
AT THE STS ANNUAL MEETING
HOUSTON – Although certain medical factors predict long-term survival in patients over age 65 years with lung cancer, advanced age and disease stage are especially strong predictors, results from a large analysis of national data demonstrated.
The findings, which were presented by Mark Onaitis, MD, at the annual meeting of the Society of Thoracic Surgeons, come from a novel effort to pair Medicare data with files from the STS General Thoracic Surgery Database (GTSD).
For the current study, he and his associates linked GTSD data to Medicare data on 29,899 patients who underwent lung cancer resection from 2002 to 2013. They used Cox proportional hazards modeling to create a long-term survival model and used statistically significant univariate factors and known clinical predictors of outcome to perform variable selection.
Dr. Onaitis reported that the median age of patients was 73 years and that 52% were female. Of the 29,899 patients, 805 had a missing pathologic stage. Of the 29,094 patients not missing a pathologic stage, 69% were stage I, 18% stage II, 11% stage III, and 2% stage IV. Two-thirds of patients (66%) underwent lobectomy, followed by wedge resection (17%), segmentectomy (7%), bilobectomy (3%), pneumonectomy (3%), and sleeve lobectomy (1%). A thoracoscopic approach was performed in nearly half of resections (47%).
Cox analysis revealed the following strong negative predictors of long-term survival: having stage III or IV-V disease (hazard ratio, 1.23 and 1.37, respectively), being age 70-74 (HR, 1.19), 75-80 (HR, 1.40), or 80 and older (HR, 1.90).
After controlling for disease stage, the following procedures were associated with increased hazard of death, compared with lobectomy: wedge resection (HR, 1.22), segmentectomy (HR, 1.10), bilobectomy (HR, 1.30), and pneumonectomy (HR, 1.58). In addition, video-assisted thoracoscopic surgery was associated with improved long-term survival, compared with thoracotomy (HR, 0.86).
“Given the large number of patients and the excellent quality of the data, it was not surprising that age and stage and known medical conditions affect long-term survival,” Dr. Onaitis commented. “The deleterious effects of sublobar operations and open [as opposed to thoracoscopic or VATS] approach were more pronounced than expected.”
Other modifiable predictive factors include being a past or current smoker (HR, 1.35 and HR, 1.54, respectively) and having a body mass index below 18.5 kg/m2 (HR, 1.58).
Dr. Onaitis acknowledged certain limitations of the study, including its retrospective design. “Because the study involves linkage of STS data to Medicare data, the findings may not be applicable to patients less than 65 years of age,” he added. He reported having no financial disclosures.
AT THE STS ANNUAL MEETING
HOUSTON – Although certain medical factors predict long-term survival in patients over age 65 years with lung cancer, advanced age and disease stage are especially strong predictors, results from a large analysis of national data demonstrated.
The findings, which were presented by Mark Onaitis, MD, at the annual meeting of the Society of Thoracic Surgeons, come from a novel effort to pair Medicare data with files from the STS General Thoracic Surgery Database (GTSD).
For the current study, he and his associates linked GTSD data to Medicare data on 29,899 patients who underwent lung cancer resection from 2002 to 2013. They used Cox proportional hazards modeling to create a long-term survival model and used statistically significant univariate factors and known clinical predictors of outcome to perform variable selection.
Dr. Onaitis reported that the median age of patients was 73 years and that 52% were female. Of the 29,899 patients, 805 had a missing pathologic stage. Of the 29,094 patients not missing a pathologic stage, 69% were stage I, 18% stage II, 11% stage III, and 2% stage IV. Two-thirds of patients (66%) underwent lobectomy, followed by wedge resection (17%), segmentectomy (7%), bilobectomy (3%), pneumonectomy (3%), and sleeve lobectomy (1%). A thoracoscopic approach was performed in nearly half of resections (47%).
Cox analysis revealed the following strong negative predictors of long-term survival: having stage III or IV-V disease (hazard ratio, 1.23 and 1.37, respectively), being age 70-74 (HR, 1.19), 75-80 (HR, 1.40), or 80 and older (HR, 1.90).
After controlling for disease stage, the following procedures were associated with increased hazard of death, compared with lobectomy: wedge resection (HR, 1.22), segmentectomy (HR, 1.10), bilobectomy (HR, 1.30), and pneumonectomy (HR, 1.58). In addition, video-assisted thoracoscopic surgery was associated with improved long-term survival, compared with thoracotomy (HR, 0.86).
“Given the large number of patients and the excellent quality of the data, it was not surprising that age and stage and known medical conditions affect long-term survival,” Dr. Onaitis commented. “The deleterious effects of sublobar operations and open [as opposed to thoracoscopic or VATS] approach were more pronounced than expected.”
Other modifiable predictive factors include being a past or current smoker (HR, 1.35 and HR, 1.54, respectively) and having a body mass index below 18.5 kg/m2 (HR, 1.58).
Dr. Onaitis acknowledged certain limitations of the study, including its retrospective design. “Because the study involves linkage of STS data to Medicare data, the findings may not be applicable to patients less than 65 years of age,” he added. He reported having no financial disclosures.
Key clinical point:
Major finding: Strong negative predictors of long-term survival included having stage III or IV-V disease (HR, 1.23 and 1.37, respectively), being age 70-74 (HR, 1.19), 75-80 (HR, 1.40), or 80 and older (HR, 1.90).
Data source: A retrospective analysis of 29,899 patients over age 65 who underwent lung cancer resection from 2002 to 2013.
Disclosures: Dr. Onaitis 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.
Subclinical AF found in 1/3 of asymptomatic elderly
NEW ORLEANS – About a third of elderly people at high cardiovascular risk but otherwise healthy and asymptomatic had subclinical atrial fibrillation in a multicenter study of 273 people.
This finding that subclinical atrial fibrillation (AF) is “extremely common” in elderly people with cardiovascular risk factors “weakens the case that detecting subclinical AF in patients following a stroke implies causality” of the stroke “because subclinical AF is so prevalent,” Jeff S. Healey, MD, said at the American Heart Association Scientific Sessions.
“I think that subclinical AF is a distinct subgroup of AF, with a risk for stroke that is quite low, about 1.5%-2% per year,” said Dr. Healey, a cardiologist at McMaster University in Hamilton, Canada. “Given that this was an elderly population [study participants averaged 74 years old] with bleeding risk, it’s reasonable to question” whether many people with subclinical AF need anticoagulation. The question of whether “45 seconds of AF seen 6 months after a stroke is worthy of treatment with an anticoagulant should give people pause,” he said.
The Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor (ASSERT-II) study initially enrolled 273 people at 26 sites in Canada and The Netherlands. Researchers actually placed a loop recorder in 256, and complete follow-up of at least 9 months occurred for 252. Enrolled patients had to be at 65 years old, and have at least one of these risk factors for AF or stroke: a CHA2DS2-VASc score of 2 or greater; documented obstructive sleep apnea; or a body mass index greater than 30 kg/m2. In addition, enrollees also had to have one of these risk factors for AF: a left atrial volume of at least 58 ml; a left atrial diameter of at least 4.4 cm; or a serum NT-proBNP level of at least 290 pg/mL.
Dr. Healey and his associates prespecified subclinical AF as at least 5 minutes of AF seen in the loop recording during follow-up, which occurred in 34% of the participants during an average 16 months of follow-up, he reported. At least 30 minutes of AF occurred in 22% during follow-up, at least 6 hours in 7%, and at least 24 hours in 3%.
In a prespecified set of subgroup analyses, people with a large left atrium formed the only subgroup with a statistically significant association with outcome. People with a left atrial size at or above the study median of 73.5 ml had an 85% increased rate of subclinical AF compared with those with smaller left atria in the multivariate analysis. But increased left atrial size alone did not fully explain subclinical atrial fibrillation. Even among participants in the lowest quartile for left atrial diameter, less than 4.3 cm, the prevalence of subclinical AF was 27%, Dr. Healey noted.
[email protected]
On Twitter @mitchelzoler
The results reported by Dr. Healey provide robust data that bridges a major gap we have had in our understanding of atrial fibrillation. The new finding of a high prevalence of subclinical atrial fibrillation in elderly people with cardiovascular risk factors, regardless of whether they had a prior stroke, substantially weakens the case that subclinical atrial fibrillation detected following a stroke has a causal relationship to the stroke. This implication is quite important.
Many questions remain about the meaning of subclinical atrial fibrillation. What relationship does it have with stroke, and what thresholds exist for atrial fibrillation to raise stroke risk? Also, what are the risks and benefits of anticoagulation in people with subclinical AF and is intermittent anticoagulation helpful?
N.A. Mark Estes III, MD , is professor of medicine and director of the New England Cardiac Arrhythmia Center at Tufts Medical Center in Boston. He has been a consultant to Boston Scientific, Medtronic and St. Jude. He made these comments as designated discussant for ASSERT-II.
The results reported by Dr. Healey provide robust data that bridges a major gap we have had in our understanding of atrial fibrillation. The new finding of a high prevalence of subclinical atrial fibrillation in elderly people with cardiovascular risk factors, regardless of whether they had a prior stroke, substantially weakens the case that subclinical atrial fibrillation detected following a stroke has a causal relationship to the stroke. This implication is quite important.
Many questions remain about the meaning of subclinical atrial fibrillation. What relationship does it have with stroke, and what thresholds exist for atrial fibrillation to raise stroke risk? Also, what are the risks and benefits of anticoagulation in people with subclinical AF and is intermittent anticoagulation helpful?
N.A. Mark Estes III, MD , is professor of medicine and director of the New England Cardiac Arrhythmia Center at Tufts Medical Center in Boston. He has been a consultant to Boston Scientific, Medtronic and St. Jude. He made these comments as designated discussant for ASSERT-II.
The results reported by Dr. Healey provide robust data that bridges a major gap we have had in our understanding of atrial fibrillation. The new finding of a high prevalence of subclinical atrial fibrillation in elderly people with cardiovascular risk factors, regardless of whether they had a prior stroke, substantially weakens the case that subclinical atrial fibrillation detected following a stroke has a causal relationship to the stroke. This implication is quite important.
Many questions remain about the meaning of subclinical atrial fibrillation. What relationship does it have with stroke, and what thresholds exist for atrial fibrillation to raise stroke risk? Also, what are the risks and benefits of anticoagulation in people with subclinical AF and is intermittent anticoagulation helpful?
N.A. Mark Estes III, MD , is professor of medicine and director of the New England Cardiac Arrhythmia Center at Tufts Medical Center in Boston. He has been a consultant to Boston Scientific, Medtronic and St. Jude. He made these comments as designated discussant for ASSERT-II.
NEW ORLEANS – About a third of elderly people at high cardiovascular risk but otherwise healthy and asymptomatic had subclinical atrial fibrillation in a multicenter study of 273 people.
This finding that subclinical atrial fibrillation (AF) is “extremely common” in elderly people with cardiovascular risk factors “weakens the case that detecting subclinical AF in patients following a stroke implies causality” of the stroke “because subclinical AF is so prevalent,” Jeff S. Healey, MD, said at the American Heart Association Scientific Sessions.
“I think that subclinical AF is a distinct subgroup of AF, with a risk for stroke that is quite low, about 1.5%-2% per year,” said Dr. Healey, a cardiologist at McMaster University in Hamilton, Canada. “Given that this was an elderly population [study participants averaged 74 years old] with bleeding risk, it’s reasonable to question” whether many people with subclinical AF need anticoagulation. The question of whether “45 seconds of AF seen 6 months after a stroke is worthy of treatment with an anticoagulant should give people pause,” he said.
The Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor (ASSERT-II) study initially enrolled 273 people at 26 sites in Canada and The Netherlands. Researchers actually placed a loop recorder in 256, and complete follow-up of at least 9 months occurred for 252. Enrolled patients had to be at 65 years old, and have at least one of these risk factors for AF or stroke: a CHA2DS2-VASc score of 2 or greater; documented obstructive sleep apnea; or a body mass index greater than 30 kg/m2. In addition, enrollees also had to have one of these risk factors for AF: a left atrial volume of at least 58 ml; a left atrial diameter of at least 4.4 cm; or a serum NT-proBNP level of at least 290 pg/mL.
Dr. Healey and his associates prespecified subclinical AF as at least 5 minutes of AF seen in the loop recording during follow-up, which occurred in 34% of the participants during an average 16 months of follow-up, he reported. At least 30 minutes of AF occurred in 22% during follow-up, at least 6 hours in 7%, and at least 24 hours in 3%.
In a prespecified set of subgroup analyses, people with a large left atrium formed the only subgroup with a statistically significant association with outcome. People with a left atrial size at or above the study median of 73.5 ml had an 85% increased rate of subclinical AF compared with those with smaller left atria in the multivariate analysis. But increased left atrial size alone did not fully explain subclinical atrial fibrillation. Even among participants in the lowest quartile for left atrial diameter, less than 4.3 cm, the prevalence of subclinical AF was 27%, Dr. Healey noted.
[email protected]
On Twitter @mitchelzoler
NEW ORLEANS – About a third of elderly people at high cardiovascular risk but otherwise healthy and asymptomatic had subclinical atrial fibrillation in a multicenter study of 273 people.
This finding that subclinical atrial fibrillation (AF) is “extremely common” in elderly people with cardiovascular risk factors “weakens the case that detecting subclinical AF in patients following a stroke implies causality” of the stroke “because subclinical AF is so prevalent,” Jeff S. Healey, MD, said at the American Heart Association Scientific Sessions.
“I think that subclinical AF is a distinct subgroup of AF, with a risk for stroke that is quite low, about 1.5%-2% per year,” said Dr. Healey, a cardiologist at McMaster University in Hamilton, Canada. “Given that this was an elderly population [study participants averaged 74 years old] with bleeding risk, it’s reasonable to question” whether many people with subclinical AF need anticoagulation. The question of whether “45 seconds of AF seen 6 months after a stroke is worthy of treatment with an anticoagulant should give people pause,” he said.
The Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor (ASSERT-II) study initially enrolled 273 people at 26 sites in Canada and The Netherlands. Researchers actually placed a loop recorder in 256, and complete follow-up of at least 9 months occurred for 252. Enrolled patients had to be at 65 years old, and have at least one of these risk factors for AF or stroke: a CHA2DS2-VASc score of 2 or greater; documented obstructive sleep apnea; or a body mass index greater than 30 kg/m2. In addition, enrollees also had to have one of these risk factors for AF: a left atrial volume of at least 58 ml; a left atrial diameter of at least 4.4 cm; or a serum NT-proBNP level of at least 290 pg/mL.
Dr. Healey and his associates prespecified subclinical AF as at least 5 minutes of AF seen in the loop recording during follow-up, which occurred in 34% of the participants during an average 16 months of follow-up, he reported. At least 30 minutes of AF occurred in 22% during follow-up, at least 6 hours in 7%, and at least 24 hours in 3%.
In a prespecified set of subgroup analyses, people with a large left atrium formed the only subgroup with a statistically significant association with outcome. People with a left atrial size at or above the study median of 73.5 ml had an 85% increased rate of subclinical AF compared with those with smaller left atria in the multivariate analysis. But increased left atrial size alone did not fully explain subclinical atrial fibrillation. Even among participants in the lowest quartile for left atrial diameter, less than 4.3 cm, the prevalence of subclinical AF was 27%, Dr. Healey noted.
[email protected]
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: One-third of asymptomatic elderly people with cardiovascular risk factors had subclinical atrial fibrillation.
Data source: A multicenter study with 252 people followed for an average of 16 months.
Disclosures: Dr. Healey has been a consultant to or received honoraria from Bayer, Medtronic, Pfizer and Servier. He has received research support from Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Medtronic and St. Jude.
President Trump hits ground running on ACA repeal
WASHINGTON – President Trump wasted no time in getting the executive branch’s wheels in motion toward repeal of the Affordable Care Act.
Within hours of being sworn in as the 45th president of the United States on Jan. 20, he signed an executive order that announced the incoming administration’s policy “to seek the prompt repeal of the Patient Protection and Affordable Care Act.”
The order opens the door for federal agencies to tackle ACA provisions such as the individual mandate and its tax penalties for not carrying insurance, as well as other financial aspects of the ACA that impact patients, providers, insurers, and manufacturers.
The order directs the secretaries of HHS, the Treasury department, and the Labor department to “exercise all authority and discretion available to them to provide greater flexibility to States and cooperate with them in implementing healthcare programs.”
With this order, President Trump also set the stage for creating a framework to sell insurance products across state lines by directing secretaries with oversight of insurance markets to “encourage the development of a free and open market in interstate commerce for the offering of healthcare services and health insurance, with the goal of achieving and preserving maximum options for patients and consumers.”
Little action is expected on the executive order until secretaries are approved for HHS, Treasury, and Labor. Rep. Tom Price (R-Ga.) is scheduled to appear before the Senate Finance Committee on Jan. 24.
WASHINGTON – President Trump wasted no time in getting the executive branch’s wheels in motion toward repeal of the Affordable Care Act.
Within hours of being sworn in as the 45th president of the United States on Jan. 20, he signed an executive order that announced the incoming administration’s policy “to seek the prompt repeal of the Patient Protection and Affordable Care Act.”
The order opens the door for federal agencies to tackle ACA provisions such as the individual mandate and its tax penalties for not carrying insurance, as well as other financial aspects of the ACA that impact patients, providers, insurers, and manufacturers.
The order directs the secretaries of HHS, the Treasury department, and the Labor department to “exercise all authority and discretion available to them to provide greater flexibility to States and cooperate with them in implementing healthcare programs.”
With this order, President Trump also set the stage for creating a framework to sell insurance products across state lines by directing secretaries with oversight of insurance markets to “encourage the development of a free and open market in interstate commerce for the offering of healthcare services and health insurance, with the goal of achieving and preserving maximum options for patients and consumers.”
Little action is expected on the executive order until secretaries are approved for HHS, Treasury, and Labor. Rep. Tom Price (R-Ga.) is scheduled to appear before the Senate Finance Committee on Jan. 24.
WASHINGTON – President Trump wasted no time in getting the executive branch’s wheels in motion toward repeal of the Affordable Care Act.
Within hours of being sworn in as the 45th president of the United States on Jan. 20, he signed an executive order that announced the incoming administration’s policy “to seek the prompt repeal of the Patient Protection and Affordable Care Act.”
The order opens the door for federal agencies to tackle ACA provisions such as the individual mandate and its tax penalties for not carrying insurance, as well as other financial aspects of the ACA that impact patients, providers, insurers, and manufacturers.
The order directs the secretaries of HHS, the Treasury department, and the Labor department to “exercise all authority and discretion available to them to provide greater flexibility to States and cooperate with them in implementing healthcare programs.”
With this order, President Trump also set the stage for creating a framework to sell insurance products across state lines by directing secretaries with oversight of insurance markets to “encourage the development of a free and open market in interstate commerce for the offering of healthcare services and health insurance, with the goal of achieving and preserving maximum options for patients and consumers.”
Little action is expected on the executive order until secretaries are approved for HHS, Treasury, and Labor. Rep. Tom Price (R-Ga.) is scheduled to appear before the Senate Finance Committee on Jan. 24.
Cardiac procedures tied to higher cancer risk in adult congenital heart disease
NEW ORLEANS – The greater the lifetime number of cardiac procedures entailing exposure to low-dose ionizing radiation, the higher the associated cancer risk in adults with congenital heart disease, Sarah Cohen, MD, reported at the American Heart Association scientific sessions.
This finding takes on added clinical import because the use of such procedures has increased markedly in patients with adult congenital heart disease, added Dr. Cohen of McGill University in Montreal.
She presented analyses of nearly 25,000 patients in the Quebec congenital heart disease database who were ages 18-64 with no history of cancer in January 1995; 602 of them were diagnosed with cancer during follow-up through 2009. Each was matched to four cancer-free controls in the database on the basis of age, sex, congenital heart disease severity, and calendar year.
Patients with a lifetime total of four or five cardiac procedures involving exposure to low-dose ionizing radiation were 1.7-fold more likely to be diagnosed with cancer during follow-up than were those with a history of no such procedures or just one. With a lifetime history of six or more of the procedures, the relative risk climbed to 2.2-fold.
Nearly 90% of the malignancies were genitourinary, respiratory, digestive, breast, or hematologic cancers.
Dr. Cohen and her coinvestigators also conducted a cohort study comparing the relative risk of developing cancer in 1,781 high-exposure Quebec adults in the database who had a lifetime history of four or more cardiac procedures involving radiation exposure to more than 20,000 others with a history of not more than one such procedure. The high-exposure group had a 3.3-fold greater rate of malignancy during follow-up.
In a separate study, Dr. Cohen’s McGill colleagues analyzed the Quebec database and documented the sharp rise over time in low-dose ionizing radiation cardiac procedures, including catheter-based diagnostic procedures, structural heart interventions, nuclear procedures, coronary interventions, computed tomography scans of the chest, coronary interventions, and insertion or repair of pacemakers and implantable cardioverter-defibrillators. In 1990, the rate was 18.5 such procedures per 1,000 patients per year. By 2005, it had nearly tripled to 51.9 per 1,000 per year. The age at first procedure dropped from 5 years to 9 months (Circulation 2016 Jan 5;133[1]:12-20).
Dr. Cohen reported having no financial disclosures.
NEW ORLEANS – The greater the lifetime number of cardiac procedures entailing exposure to low-dose ionizing radiation, the higher the associated cancer risk in adults with congenital heart disease, Sarah Cohen, MD, reported at the American Heart Association scientific sessions.
This finding takes on added clinical import because the use of such procedures has increased markedly in patients with adult congenital heart disease, added Dr. Cohen of McGill University in Montreal.
She presented analyses of nearly 25,000 patients in the Quebec congenital heart disease database who were ages 18-64 with no history of cancer in January 1995; 602 of them were diagnosed with cancer during follow-up through 2009. Each was matched to four cancer-free controls in the database on the basis of age, sex, congenital heart disease severity, and calendar year.
Patients with a lifetime total of four or five cardiac procedures involving exposure to low-dose ionizing radiation were 1.7-fold more likely to be diagnosed with cancer during follow-up than were those with a history of no such procedures or just one. With a lifetime history of six or more of the procedures, the relative risk climbed to 2.2-fold.
Nearly 90% of the malignancies were genitourinary, respiratory, digestive, breast, or hematologic cancers.
Dr. Cohen and her coinvestigators also conducted a cohort study comparing the relative risk of developing cancer in 1,781 high-exposure Quebec adults in the database who had a lifetime history of four or more cardiac procedures involving radiation exposure to more than 20,000 others with a history of not more than one such procedure. The high-exposure group had a 3.3-fold greater rate of malignancy during follow-up.
In a separate study, Dr. Cohen’s McGill colleagues analyzed the Quebec database and documented the sharp rise over time in low-dose ionizing radiation cardiac procedures, including catheter-based diagnostic procedures, structural heart interventions, nuclear procedures, coronary interventions, computed tomography scans of the chest, coronary interventions, and insertion or repair of pacemakers and implantable cardioverter-defibrillators. In 1990, the rate was 18.5 such procedures per 1,000 patients per year. By 2005, it had nearly tripled to 51.9 per 1,000 per year. The age at first procedure dropped from 5 years to 9 months (Circulation 2016 Jan 5;133[1]:12-20).
Dr. Cohen reported having no financial disclosures.
NEW ORLEANS – The greater the lifetime number of cardiac procedures entailing exposure to low-dose ionizing radiation, the higher the associated cancer risk in adults with congenital heart disease, Sarah Cohen, MD, reported at the American Heart Association scientific sessions.
This finding takes on added clinical import because the use of such procedures has increased markedly in patients with adult congenital heart disease, added Dr. Cohen of McGill University in Montreal.
She presented analyses of nearly 25,000 patients in the Quebec congenital heart disease database who were ages 18-64 with no history of cancer in January 1995; 602 of them were diagnosed with cancer during follow-up through 2009. Each was matched to four cancer-free controls in the database on the basis of age, sex, congenital heart disease severity, and calendar year.
Patients with a lifetime total of four or five cardiac procedures involving exposure to low-dose ionizing radiation were 1.7-fold more likely to be diagnosed with cancer during follow-up than were those with a history of no such procedures or just one. With a lifetime history of six or more of the procedures, the relative risk climbed to 2.2-fold.
Nearly 90% of the malignancies were genitourinary, respiratory, digestive, breast, or hematologic cancers.
Dr. Cohen and her coinvestigators also conducted a cohort study comparing the relative risk of developing cancer in 1,781 high-exposure Quebec adults in the database who had a lifetime history of four or more cardiac procedures involving radiation exposure to more than 20,000 others with a history of not more than one such procedure. The high-exposure group had a 3.3-fold greater rate of malignancy during follow-up.
In a separate study, Dr. Cohen’s McGill colleagues analyzed the Quebec database and documented the sharp rise over time in low-dose ionizing radiation cardiac procedures, including catheter-based diagnostic procedures, structural heart interventions, nuclear procedures, coronary interventions, computed tomography scans of the chest, coronary interventions, and insertion or repair of pacemakers and implantable cardioverter-defibrillators. In 1990, the rate was 18.5 such procedures per 1,000 patients per year. By 2005, it had nearly tripled to 51.9 per 1,000 per year. The age at first procedure dropped from 5 years to 9 months (Circulation 2016 Jan 5;133[1]:12-20).
Dr. Cohen reported having no financial disclosures.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Adults with congenital heart disease who had a lifetime history of six or more cardiac procedures involving exposure to low-dose ionizing radiation were 2.2-fold more likely to develop cancer during follow-up than were those with not more than one such procedure.
Data source: This nested, case-control study included 602 adults with congenital heart disease who developed cancer, each matched to four controls who did not.
Disclosures: The study presenter reported having no 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.
Sleeve lobectomy appears better than pneumonectomy for NSCLC
Guidelines that recommend sleeve lobectomy as a means of avoiding pneumonectomy for lung cancer have been based on a limited retrospective series, but a large series drawn from a nationwide database in France has confirmed the preference for sleeve lobectomy because it leads to higher rates of survival, despite an increased risk of postoperative pulmonary complications.
“Whenever it is technically possible, surgeons must perform sleeve lobectomy to provide more long-term survival benefits to patients, even with the risk of more postoperative pulmonary complications,” said Pierre-Benoit Pagès, MD, PhD, and his coauthors in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:184-95). Dr. Pagès is with the department of thoracic and cardiovascular surgery at the University Hospital Center Dijon (France) and Bocage Hospital.
Three-year overall survival was 71.9% for the sleeve lobectomy group vs. 60.8% for the pneumonectomy group. Three-year disease-free survival was 46.4% for the sleeve lobectomy group and 31.6% for the pneumonectomy group. In addition, compared with the sleeve lobectomy group, the pneumonectomy group had an increased risk of recurrence by matching (hazard ratio, 1.49; 95% CI, 1.1-2).
The researchers performed a propensity-matched analysis that favored sleeve lobectomy for early overall and disease-free survival, but the weighted analysis did not. Patients in the sleeve lobectomy group vs. the pneumonectomy group were younger (60.9 years vs. 61.9), had higher body mass index (25.6 vs. 25.1), had higher average forced expiratory volume (74.1% vs. 62.9%), and had lower American Society of Anesthesiologists scores (73.7% with scores of 1 and 2 vs. 70.8%). Sleeve lobectomy patients also were more likely to have right-sided surgery (69.6% vs. 41%) and squamous cell carcinoma (54.6% vs. 48.3%), and lower T and N stages (T1 and T2, 60.5% vs. 40.6%; N0, 40.9% vs. 26.2%).
Overall mortality after surgery was 5% in the sleeve lobectomy group vs. 5.9% in the pneumonectomy group, but propensity scoring showed far fewer postoperative pulmonary complications in the pneumonectomy group, with an odds ratio of 0.4, Dr. Pagès and his coauthors said. However, with other significant complications – arrhythmia, bronchopleural fistula, empyema, and hemorrhage – pneumonectomy had a propensity-matched odds ratio ranging from 1.6 to 7. “We found no significant difference regarding postoperative mortality in the sleeve lobectomy and pneumonectomy groups, whatever the statistical method used,” Dr. Pagès and his coauthors wrote.
The investigators had no financial relationships to disclose.
The study by Dr. Pagès and his colleagues is unique in the field of surgery for non–small cell lung cancer in that it drew on a nationwide database using data from 103 centers, Betty C. Tong, MD, MHS, of Duke University Medical Center, Durham, said in her invited commentary (J Thorac Cardiovasc Surg. 2017;153:196). “These results are likely as close to real life as possible,” she said.
She acknowledged that no prospective, randomized controlled trials have compared sleeve lobectomy to pneumonectomy, but she added, “it is unlikely that such a trial could be successfully executed.” The 5:1 ratio of patients having pneumonectomy vs. sleeve lobectomy in this study is similar to findings from the Society of Thoracic Surgeons General Thoracic Surgery database (J Thorac Cardiovasc Surg. 2008;132:247-54), Dr. Tong pointed out, “and likely reflects the fact that sleeve lobectomy can be technically more difficult to perform.”
The findings of the French Society of Thoracic and Cardiovascular Surgery group “should strongly encourage thoracic surgeons to perform pneumonectomy as sparingly as possible,” and consider sleeve lobectomy the standard for patients with central tumors, Dr. Tong said.
She had no financial relationships to disclose.
The study by Dr. Pagès and his colleagues is unique in the field of surgery for non–small cell lung cancer in that it drew on a nationwide database using data from 103 centers, Betty C. Tong, MD, MHS, of Duke University Medical Center, Durham, said in her invited commentary (J Thorac Cardiovasc Surg. 2017;153:196). “These results are likely as close to real life as possible,” she said.
She acknowledged that no prospective, randomized controlled trials have compared sleeve lobectomy to pneumonectomy, but she added, “it is unlikely that such a trial could be successfully executed.” The 5:1 ratio of patients having pneumonectomy vs. sleeve lobectomy in this study is similar to findings from the Society of Thoracic Surgeons General Thoracic Surgery database (J Thorac Cardiovasc Surg. 2008;132:247-54), Dr. Tong pointed out, “and likely reflects the fact that sleeve lobectomy can be technically more difficult to perform.”
The findings of the French Society of Thoracic and Cardiovascular Surgery group “should strongly encourage thoracic surgeons to perform pneumonectomy as sparingly as possible,” and consider sleeve lobectomy the standard for patients with central tumors, Dr. Tong said.
She had no financial relationships to disclose.
The study by Dr. Pagès and his colleagues is unique in the field of surgery for non–small cell lung cancer in that it drew on a nationwide database using data from 103 centers, Betty C. Tong, MD, MHS, of Duke University Medical Center, Durham, said in her invited commentary (J Thorac Cardiovasc Surg. 2017;153:196). “These results are likely as close to real life as possible,” she said.
She acknowledged that no prospective, randomized controlled trials have compared sleeve lobectomy to pneumonectomy, but she added, “it is unlikely that such a trial could be successfully executed.” The 5:1 ratio of patients having pneumonectomy vs. sleeve lobectomy in this study is similar to findings from the Society of Thoracic Surgeons General Thoracic Surgery database (J Thorac Cardiovasc Surg. 2008;132:247-54), Dr. Tong pointed out, “and likely reflects the fact that sleeve lobectomy can be technically more difficult to perform.”
The findings of the French Society of Thoracic and Cardiovascular Surgery group “should strongly encourage thoracic surgeons to perform pneumonectomy as sparingly as possible,” and consider sleeve lobectomy the standard for patients with central tumors, Dr. Tong said.
She had no financial relationships to disclose.
Guidelines that recommend sleeve lobectomy as a means of avoiding pneumonectomy for lung cancer have been based on a limited retrospective series, but a large series drawn from a nationwide database in France has confirmed the preference for sleeve lobectomy because it leads to higher rates of survival, despite an increased risk of postoperative pulmonary complications.
“Whenever it is technically possible, surgeons must perform sleeve lobectomy to provide more long-term survival benefits to patients, even with the risk of more postoperative pulmonary complications,” said Pierre-Benoit Pagès, MD, PhD, and his coauthors in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:184-95). Dr. Pagès is with the department of thoracic and cardiovascular surgery at the University Hospital Center Dijon (France) and Bocage Hospital.
Three-year overall survival was 71.9% for the sleeve lobectomy group vs. 60.8% for the pneumonectomy group. Three-year disease-free survival was 46.4% for the sleeve lobectomy group and 31.6% for the pneumonectomy group. In addition, compared with the sleeve lobectomy group, the pneumonectomy group had an increased risk of recurrence by matching (hazard ratio, 1.49; 95% CI, 1.1-2).
The researchers performed a propensity-matched analysis that favored sleeve lobectomy for early overall and disease-free survival, but the weighted analysis did not. Patients in the sleeve lobectomy group vs. the pneumonectomy group were younger (60.9 years vs. 61.9), had higher body mass index (25.6 vs. 25.1), had higher average forced expiratory volume (74.1% vs. 62.9%), and had lower American Society of Anesthesiologists scores (73.7% with scores of 1 and 2 vs. 70.8%). Sleeve lobectomy patients also were more likely to have right-sided surgery (69.6% vs. 41%) and squamous cell carcinoma (54.6% vs. 48.3%), and lower T and N stages (T1 and T2, 60.5% vs. 40.6%; N0, 40.9% vs. 26.2%).
Overall mortality after surgery was 5% in the sleeve lobectomy group vs. 5.9% in the pneumonectomy group, but propensity scoring showed far fewer postoperative pulmonary complications in the pneumonectomy group, with an odds ratio of 0.4, Dr. Pagès and his coauthors said. However, with other significant complications – arrhythmia, bronchopleural fistula, empyema, and hemorrhage – pneumonectomy had a propensity-matched odds ratio ranging from 1.6 to 7. “We found no significant difference regarding postoperative mortality in the sleeve lobectomy and pneumonectomy groups, whatever the statistical method used,” Dr. Pagès and his coauthors wrote.
The investigators had no financial relationships to disclose.
Guidelines that recommend sleeve lobectomy as a means of avoiding pneumonectomy for lung cancer have been based on a limited retrospective series, but a large series drawn from a nationwide database in France has confirmed the preference for sleeve lobectomy because it leads to higher rates of survival, despite an increased risk of postoperative pulmonary complications.
“Whenever it is technically possible, surgeons must perform sleeve lobectomy to provide more long-term survival benefits to patients, even with the risk of more postoperative pulmonary complications,” said Pierre-Benoit Pagès, MD, PhD, and his coauthors in the January 2017 issue of the Journal of Thoracic and Cardiovascular Surgery (2017;153:184-95). Dr. Pagès is with the department of thoracic and cardiovascular surgery at the University Hospital Center Dijon (France) and Bocage Hospital.
Three-year overall survival was 71.9% for the sleeve lobectomy group vs. 60.8% for the pneumonectomy group. Three-year disease-free survival was 46.4% for the sleeve lobectomy group and 31.6% for the pneumonectomy group. In addition, compared with the sleeve lobectomy group, the pneumonectomy group had an increased risk of recurrence by matching (hazard ratio, 1.49; 95% CI, 1.1-2).
The researchers performed a propensity-matched analysis that favored sleeve lobectomy for early overall and disease-free survival, but the weighted analysis did not. Patients in the sleeve lobectomy group vs. the pneumonectomy group were younger (60.9 years vs. 61.9), had higher body mass index (25.6 vs. 25.1), had higher average forced expiratory volume (74.1% vs. 62.9%), and had lower American Society of Anesthesiologists scores (73.7% with scores of 1 and 2 vs. 70.8%). Sleeve lobectomy patients also were more likely to have right-sided surgery (69.6% vs. 41%) and squamous cell carcinoma (54.6% vs. 48.3%), and lower T and N stages (T1 and T2, 60.5% vs. 40.6%; N0, 40.9% vs. 26.2%).
Overall mortality after surgery was 5% in the sleeve lobectomy group vs. 5.9% in the pneumonectomy group, but propensity scoring showed far fewer postoperative pulmonary complications in the pneumonectomy group, with an odds ratio of 0.4, Dr. Pagès and his coauthors said. However, with other significant complications – arrhythmia, bronchopleural fistula, empyema, and hemorrhage – pneumonectomy had a propensity-matched odds ratio ranging from 1.6 to 7. “We found no significant difference regarding postoperative mortality in the sleeve lobectomy and pneumonectomy groups, whatever the statistical method used,” Dr. Pagès and his coauthors wrote.
The investigators had no financial relationships to disclose.
Key clinical point: Sleeve lobectomy for non–small cell lung cancer may lead to higher rates of overall and disease-free survival vs. pneumonectomy.
Major finding: Overall postoperative mortality was 5% in the sleeve lobectomy group vs. 5.9% in the pneumonectomy group.
Data source: An analysis of 941 sleeve lobectomy and 5,318 pneumonectomy procedures from 2005 to 2014 in the nationwide French database Epithor.
Disclosures: Dr. Pagès has received research grants from the Nuovo-Soldati Foundation for Cancer Research and the French Society of Thoracic and Cardiovascular Surgery, on whose behalf the study was performed. Dr. Pagès and his coauthors had no financial relationships to disclose.
ACA repeal would impact adults at higher risk of chronic disease
Individuals at risk of losing health insurance with a potential repeal of the Affordable Care Act have significantly higher rates of self-reported poor health and are more likely to have certain chronic diseases, according to a research letter published Jan. 20 in JAMA Internal Medicine.
Researchers looked at data from the National Health Interview Survey, focusing on the three groups of adults under 65 years who would be most likely to lose their health insurance if the ACA were repealed: those with incomes below 400% of the federal poverty level (FPL) who purchased insurance through the health insurance exchanges, childless adults with incomes below 138% of the FPL who gained coverage via expanded Medicaid, and Medicaid-enrolled parents or adults in families with children who did not receive disability insurance and whose income was 50%-138% of the FPL.
“Approximately 20 million individuals have gained health insurance under the Affordable Care Act (ACA), including young adults covered under parental insurance, those purchasing private insurance on exchanges, and those covered through state Medicaid expansion,” wrote Pinar Karaca-Mandic, PhD, of the University of Minnesota School of Public Health, Minneapolis, and her coauthors. “As of mid-2016, 10.4 million individuals had private insurance policies through the exchanges, of whom 84% had incomes below 400% of the federal poverty level (FPL) and received premium tax credits.”
Compared with adults under 65 who had employer-sponsored health insurance, adults in these three groups were significantly more likely to self-report their health as “fair or poor” (JAMA Intern Med. 2017 Jan 20. doi: 10.1001/jamainternmed.2016.9541).
Adults without children and with incomes below 138% of the federal poverty level also had a significantly greater incidence of hypertension, coronary heart disease, cancer, diabetes, stroke, or any heart condition, compared with individuals with employer-sponsored insurance.
They were also significantly more likely to have visited a physician 10 or more times or visited the emergency department at least twice in the past year, and to have undergone surgery in the past year.
“Our analysis highlights the socioeconomic vulnerability and rates of chronic diseases and health care utilization of individuals at risk to lose health insurance if the ACA is modified or repealed,” according to Dr. Karaca-Mandic. “These consequences point to the challenges Congress should address before enacting new health care legislation.”
The study was supported by the NIH Early Independence Award. One author declared consulting fees from the pharmaceutical industry, and another declared private sector support through Yale University. No other conflicts of interest were declared.
We believe that health care is a right, not a privilege, and all Americans should have access to high-quality health care, regardless of their income or personal circumstances. The United States has the most advanced health care system in the world by many criteria, but access to the system is uneven. Even with the ACA, 29 million people were without health insurance coverage for the entire 2015 calendar year.
The central questions remain of how to attain a health care system that is accessible to all Americans, that provides needed care while avoiding unnecessary care, and that delivers care at an affordable and sustainable price. The next steps are to build on the progress that has been made, which will require further improvements in health insurance coverage, the ability of people to obtain needed medical care regardless of income, and a continued shift away from fee-for-service medicine. The future is about universal health care coverage and access, improved quality, and payment reforms that will have a meaningful impact on the costs of health care and prescription drugs.
Rita F. Redberg, MD, is the editor of JAMA Internal Medicine, Robert Steinbrook, MD, is an editor at large, and Mitchell H. Katz, MD, is deputy editor. Their comments are taken from an accompanying editorial (JAMA Intern Med 2017 Jan 20. doi: 10.1001/jamainternmed.2016.9542). No conflicts of interest were declared.
We believe that health care is a right, not a privilege, and all Americans should have access to high-quality health care, regardless of their income or personal circumstances. The United States has the most advanced health care system in the world by many criteria, but access to the system is uneven. Even with the ACA, 29 million people were without health insurance coverage for the entire 2015 calendar year.
The central questions remain of how to attain a health care system that is accessible to all Americans, that provides needed care while avoiding unnecessary care, and that delivers care at an affordable and sustainable price. The next steps are to build on the progress that has been made, which will require further improvements in health insurance coverage, the ability of people to obtain needed medical care regardless of income, and a continued shift away from fee-for-service medicine. The future is about universal health care coverage and access, improved quality, and payment reforms that will have a meaningful impact on the costs of health care and prescription drugs.
Rita F. Redberg, MD, is the editor of JAMA Internal Medicine, Robert Steinbrook, MD, is an editor at large, and Mitchell H. Katz, MD, is deputy editor. Their comments are taken from an accompanying editorial (JAMA Intern Med 2017 Jan 20. doi: 10.1001/jamainternmed.2016.9542). No conflicts of interest were declared.
We believe that health care is a right, not a privilege, and all Americans should have access to high-quality health care, regardless of their income or personal circumstances. The United States has the most advanced health care system in the world by many criteria, but access to the system is uneven. Even with the ACA, 29 million people were without health insurance coverage for the entire 2015 calendar year.
The central questions remain of how to attain a health care system that is accessible to all Americans, that provides needed care while avoiding unnecessary care, and that delivers care at an affordable and sustainable price. The next steps are to build on the progress that has been made, which will require further improvements in health insurance coverage, the ability of people to obtain needed medical care regardless of income, and a continued shift away from fee-for-service medicine. The future is about universal health care coverage and access, improved quality, and payment reforms that will have a meaningful impact on the costs of health care and prescription drugs.
Rita F. Redberg, MD, is the editor of JAMA Internal Medicine, Robert Steinbrook, MD, is an editor at large, and Mitchell H. Katz, MD, is deputy editor. Their comments are taken from an accompanying editorial (JAMA Intern Med 2017 Jan 20. doi: 10.1001/jamainternmed.2016.9542). No conflicts of interest were declared.
Individuals at risk of losing health insurance with a potential repeal of the Affordable Care Act have significantly higher rates of self-reported poor health and are more likely to have certain chronic diseases, according to a research letter published Jan. 20 in JAMA Internal Medicine.
Researchers looked at data from the National Health Interview Survey, focusing on the three groups of adults under 65 years who would be most likely to lose their health insurance if the ACA were repealed: those with incomes below 400% of the federal poverty level (FPL) who purchased insurance through the health insurance exchanges, childless adults with incomes below 138% of the FPL who gained coverage via expanded Medicaid, and Medicaid-enrolled parents or adults in families with children who did not receive disability insurance and whose income was 50%-138% of the FPL.
“Approximately 20 million individuals have gained health insurance under the Affordable Care Act (ACA), including young adults covered under parental insurance, those purchasing private insurance on exchanges, and those covered through state Medicaid expansion,” wrote Pinar Karaca-Mandic, PhD, of the University of Minnesota School of Public Health, Minneapolis, and her coauthors. “As of mid-2016, 10.4 million individuals had private insurance policies through the exchanges, of whom 84% had incomes below 400% of the federal poverty level (FPL) and received premium tax credits.”
Compared with adults under 65 who had employer-sponsored health insurance, adults in these three groups were significantly more likely to self-report their health as “fair or poor” (JAMA Intern Med. 2017 Jan 20. doi: 10.1001/jamainternmed.2016.9541).
Adults without children and with incomes below 138% of the federal poverty level also had a significantly greater incidence of hypertension, coronary heart disease, cancer, diabetes, stroke, or any heart condition, compared with individuals with employer-sponsored insurance.
They were also significantly more likely to have visited a physician 10 or more times or visited the emergency department at least twice in the past year, and to have undergone surgery in the past year.
“Our analysis highlights the socioeconomic vulnerability and rates of chronic diseases and health care utilization of individuals at risk to lose health insurance if the ACA is modified or repealed,” according to Dr. Karaca-Mandic. “These consequences point to the challenges Congress should address before enacting new health care legislation.”
The study was supported by the NIH Early Independence Award. One author declared consulting fees from the pharmaceutical industry, and another declared private sector support through Yale University. No other conflicts of interest were declared.
Individuals at risk of losing health insurance with a potential repeal of the Affordable Care Act have significantly higher rates of self-reported poor health and are more likely to have certain chronic diseases, according to a research letter published Jan. 20 in JAMA Internal Medicine.
Researchers looked at data from the National Health Interview Survey, focusing on the three groups of adults under 65 years who would be most likely to lose their health insurance if the ACA were repealed: those with incomes below 400% of the federal poverty level (FPL) who purchased insurance through the health insurance exchanges, childless adults with incomes below 138% of the FPL who gained coverage via expanded Medicaid, and Medicaid-enrolled parents or adults in families with children who did not receive disability insurance and whose income was 50%-138% of the FPL.
“Approximately 20 million individuals have gained health insurance under the Affordable Care Act (ACA), including young adults covered under parental insurance, those purchasing private insurance on exchanges, and those covered through state Medicaid expansion,” wrote Pinar Karaca-Mandic, PhD, of the University of Minnesota School of Public Health, Minneapolis, and her coauthors. “As of mid-2016, 10.4 million individuals had private insurance policies through the exchanges, of whom 84% had incomes below 400% of the federal poverty level (FPL) and received premium tax credits.”
Compared with adults under 65 who had employer-sponsored health insurance, adults in these three groups were significantly more likely to self-report their health as “fair or poor” (JAMA Intern Med. 2017 Jan 20. doi: 10.1001/jamainternmed.2016.9541).
Adults without children and with incomes below 138% of the federal poverty level also had a significantly greater incidence of hypertension, coronary heart disease, cancer, diabetes, stroke, or any heart condition, compared with individuals with employer-sponsored insurance.
They were also significantly more likely to have visited a physician 10 or more times or visited the emergency department at least twice in the past year, and to have undergone surgery in the past year.
“Our analysis highlights the socioeconomic vulnerability and rates of chronic diseases and health care utilization of individuals at risk to lose health insurance if the ACA is modified or repealed,” according to Dr. Karaca-Mandic. “These consequences point to the challenges Congress should address before enacting new health care legislation.”
The study was supported by the NIH Early Independence Award. One author declared consulting fees from the pharmaceutical industry, and another declared private sector support through Yale University. No other conflicts of interest were declared.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Adults at risk of losing health coverage if the Affordable Care Act were repealed have significantly higher rates of poor health and are more likely to suffer chronic diseases.
Major finding: Individuals at risk of losing health insurance with the rollback of the Affordable Care Act are significantly more likely than individuals with employer-sponsored health insurance to self-report their health as “fair or poor.”
Data source: An analysis of data from the population-based National Health Interview Survey.
Disclosures: The study was supported by the NIH Early Independence Award. One author declared consulting fees from the pharmaceutical industry, and another declared private sector support through Yale University. No other conflicts of interest were declared.