User login
The Official Newspaper of the American Association for Thoracic Surgery
Antibiotic-resistant infections remain a persistent threat
One in every seven infections in acute care hospitals related to catheters and surgeries was caused by antibiotic-resistant bacteria. In long-term acute care hospitals, that number increased to one in four.
Those are key findings from a study published March 3 in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report that is the first to combine national data on antibiotic-resistant (AR) bacteria threats with progress on health care–associated infections (HAIs).
“Antibiotic resistance threatens to return us to a time when a simple infection could kill,” CDC Director Thomas Frieden said during a March 3 telebriefing. “The more people who get infected with resistant bacteria, the more people who suffer complications, the more who, tragically, may die from preventable infections. On any given day about one in 25 hospitalized patients has at least one health care–associated infection that they didn’t come in with. No one should get sick when they’re trying to get well.”
For the study, researchers led by Dr. Clifford McDonald of the CDC’s Division of Healthcare Quality Promotion, collected data on specific infections that were reported to the National Healthcare Safety Network in 2014 by approximately 4,000 short-term acute care hospitals, 501 long-term acute care hospitals, and 1,135 inpatient rehabilitation facilities in all 50 states (MMWR. 2016 Mar 3. doi: 10.15585/mmwr.mm6509e1er). Next, they determined the proportions of AR pathogens and HAIs caused by any of six resistant bacteria highlighted by the CDC in 2013 as urgent or serious threats: CRE (carbapenem-resistant Enterobacteriaceae), MRSA (methicillin-resistant Staphylococcus aureus), ESBL-producing Enterobacteriaceae (extended-spectrum beta-lactamases), VRE (vancomycin-resistant enterococci), multidrug-resistant pseudomonas, and multidrug-resistant Acinetobacter.
The researchers found that, compared with historical data from 5-8 years earlier, central line–associated bloodstream infections decreased by 50% and surgical site infections (SSIs) by 17% in 2014.
“There is encouraging news here,” Dr. Frieden said. “Doctors, nurses, hospitals, health care systems and other partners have made progress preventing some health care–associated infections.” However, the study found that one in six remaining central line-associated bloodstream infections were caused by urgent or serious antibiotic-resistant bacteria, while one in seven remaining surgical site infections were caused by urgent or serious antibiotic-resistant bacteria.
While catheter-associated urinary tract infections appear unchanged from baseline, there have been recent decreases, according to the study. In addition, C. difficile infections in hospitals decreased 8% between 2011 and 2014.
Dr. McDonald and his associates determined that in 2014, one in seven infections in acute care hospitals related to catheters and surgeries was caused by one of the six antibiotic-resistance threat bacteria, “which is deeply concerning,” Dr. Frieden said. That number increased to one in four infections in long-term acute care hospitals, a proportion that he characterized as “chilling.”
The CDC recommends three strategies that doctors, nurses, and other health care providers should take with every patient, to prevent HAIs and stop the spread of antibiotic resistance:
• Prevent the spread of bacteria between patients. Dr. Peter Pronovost, who participated in the telebriefing, said that he and his associates at Johns Hopkins University in Baltimore “do this by practicing good hand hygiene techniques by wearing sterile equipment when inserting lines.”
• Prevent surgery-related infections and/or placement of a catheter. “Check catheters frequently and remove them when you no longer need them,” advised Dr. Pronovost, director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins. “Ask if you actually need them before you even place them.”
• Improve antibiotic use through stewardship. This means using “the right antibiotics for the right duration,” Dr. Pronovost said. “Antibiotics could be lifesaving and are necessary for critically ill patients, especially those with septic shock. But these antibiotics need to be adjusted based on lab results and new information about the organisms that are causing these infections. Forty-eight hours after antibiotics are initiated, take a ‘time out.’ Perform a brief but focused assessment to determine if antibiotic therapy is still needed, or if it should be refined. A common mistake we make is to continue vancomycin when there is no presence of MRSA. We often tell our staff at Johns Hopkins, ‘if it doesn’t grow, let it go.’ ”
Dr. Frieden concluded his remarks by noting that physicians and other clinicians on the front lines “need support of their facility leadership,” to prevent HAIs. “Health care facilities, CEOs, and administrators are a major part of the solution. It’s important that they make a priority of infection prevention, sepsis prevention, and antibiotic stewardship. Know your facility’s data and target prevention efforts to ensure improvements in patient safety.”
One in every seven infections in acute care hospitals related to catheters and surgeries was caused by antibiotic-resistant bacteria. In long-term acute care hospitals, that number increased to one in four.
Those are key findings from a study published March 3 in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report that is the first to combine national data on antibiotic-resistant (AR) bacteria threats with progress on health care–associated infections (HAIs).
“Antibiotic resistance threatens to return us to a time when a simple infection could kill,” CDC Director Thomas Frieden said during a March 3 telebriefing. “The more people who get infected with resistant bacteria, the more people who suffer complications, the more who, tragically, may die from preventable infections. On any given day about one in 25 hospitalized patients has at least one health care–associated infection that they didn’t come in with. No one should get sick when they’re trying to get well.”
For the study, researchers led by Dr. Clifford McDonald of the CDC’s Division of Healthcare Quality Promotion, collected data on specific infections that were reported to the National Healthcare Safety Network in 2014 by approximately 4,000 short-term acute care hospitals, 501 long-term acute care hospitals, and 1,135 inpatient rehabilitation facilities in all 50 states (MMWR. 2016 Mar 3. doi: 10.15585/mmwr.mm6509e1er). Next, they determined the proportions of AR pathogens and HAIs caused by any of six resistant bacteria highlighted by the CDC in 2013 as urgent or serious threats: CRE (carbapenem-resistant Enterobacteriaceae), MRSA (methicillin-resistant Staphylococcus aureus), ESBL-producing Enterobacteriaceae (extended-spectrum beta-lactamases), VRE (vancomycin-resistant enterococci), multidrug-resistant pseudomonas, and multidrug-resistant Acinetobacter.
The researchers found that, compared with historical data from 5-8 years earlier, central line–associated bloodstream infections decreased by 50% and surgical site infections (SSIs) by 17% in 2014.
“There is encouraging news here,” Dr. Frieden said. “Doctors, nurses, hospitals, health care systems and other partners have made progress preventing some health care–associated infections.” However, the study found that one in six remaining central line-associated bloodstream infections were caused by urgent or serious antibiotic-resistant bacteria, while one in seven remaining surgical site infections were caused by urgent or serious antibiotic-resistant bacteria.
While catheter-associated urinary tract infections appear unchanged from baseline, there have been recent decreases, according to the study. In addition, C. difficile infections in hospitals decreased 8% between 2011 and 2014.
Dr. McDonald and his associates determined that in 2014, one in seven infections in acute care hospitals related to catheters and surgeries was caused by one of the six antibiotic-resistance threat bacteria, “which is deeply concerning,” Dr. Frieden said. That number increased to one in four infections in long-term acute care hospitals, a proportion that he characterized as “chilling.”
The CDC recommends three strategies that doctors, nurses, and other health care providers should take with every patient, to prevent HAIs and stop the spread of antibiotic resistance:
• Prevent the spread of bacteria between patients. Dr. Peter Pronovost, who participated in the telebriefing, said that he and his associates at Johns Hopkins University in Baltimore “do this by practicing good hand hygiene techniques by wearing sterile equipment when inserting lines.”
• Prevent surgery-related infections and/or placement of a catheter. “Check catheters frequently and remove them when you no longer need them,” advised Dr. Pronovost, director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins. “Ask if you actually need them before you even place them.”
• Improve antibiotic use through stewardship. This means using “the right antibiotics for the right duration,” Dr. Pronovost said. “Antibiotics could be lifesaving and are necessary for critically ill patients, especially those with septic shock. But these antibiotics need to be adjusted based on lab results and new information about the organisms that are causing these infections. Forty-eight hours after antibiotics are initiated, take a ‘time out.’ Perform a brief but focused assessment to determine if antibiotic therapy is still needed, or if it should be refined. A common mistake we make is to continue vancomycin when there is no presence of MRSA. We often tell our staff at Johns Hopkins, ‘if it doesn’t grow, let it go.’ ”
Dr. Frieden concluded his remarks by noting that physicians and other clinicians on the front lines “need support of their facility leadership,” to prevent HAIs. “Health care facilities, CEOs, and administrators are a major part of the solution. It’s important that they make a priority of infection prevention, sepsis prevention, and antibiotic stewardship. Know your facility’s data and target prevention efforts to ensure improvements in patient safety.”
One in every seven infections in acute care hospitals related to catheters and surgeries was caused by antibiotic-resistant bacteria. In long-term acute care hospitals, that number increased to one in four.
Those are key findings from a study published March 3 in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report that is the first to combine national data on antibiotic-resistant (AR) bacteria threats with progress on health care–associated infections (HAIs).
“Antibiotic resistance threatens to return us to a time when a simple infection could kill,” CDC Director Thomas Frieden said during a March 3 telebriefing. “The more people who get infected with resistant bacteria, the more people who suffer complications, the more who, tragically, may die from preventable infections. On any given day about one in 25 hospitalized patients has at least one health care–associated infection that they didn’t come in with. No one should get sick when they’re trying to get well.”
For the study, researchers led by Dr. Clifford McDonald of the CDC’s Division of Healthcare Quality Promotion, collected data on specific infections that were reported to the National Healthcare Safety Network in 2014 by approximately 4,000 short-term acute care hospitals, 501 long-term acute care hospitals, and 1,135 inpatient rehabilitation facilities in all 50 states (MMWR. 2016 Mar 3. doi: 10.15585/mmwr.mm6509e1er). Next, they determined the proportions of AR pathogens and HAIs caused by any of six resistant bacteria highlighted by the CDC in 2013 as urgent or serious threats: CRE (carbapenem-resistant Enterobacteriaceae), MRSA (methicillin-resistant Staphylococcus aureus), ESBL-producing Enterobacteriaceae (extended-spectrum beta-lactamases), VRE (vancomycin-resistant enterococci), multidrug-resistant pseudomonas, and multidrug-resistant Acinetobacter.
The researchers found that, compared with historical data from 5-8 years earlier, central line–associated bloodstream infections decreased by 50% and surgical site infections (SSIs) by 17% in 2014.
“There is encouraging news here,” Dr. Frieden said. “Doctors, nurses, hospitals, health care systems and other partners have made progress preventing some health care–associated infections.” However, the study found that one in six remaining central line-associated bloodstream infections were caused by urgent or serious antibiotic-resistant bacteria, while one in seven remaining surgical site infections were caused by urgent or serious antibiotic-resistant bacteria.
While catheter-associated urinary tract infections appear unchanged from baseline, there have been recent decreases, according to the study. In addition, C. difficile infections in hospitals decreased 8% between 2011 and 2014.
Dr. McDonald and his associates determined that in 2014, one in seven infections in acute care hospitals related to catheters and surgeries was caused by one of the six antibiotic-resistance threat bacteria, “which is deeply concerning,” Dr. Frieden said. That number increased to one in four infections in long-term acute care hospitals, a proportion that he characterized as “chilling.”
The CDC recommends three strategies that doctors, nurses, and other health care providers should take with every patient, to prevent HAIs and stop the spread of antibiotic resistance:
• Prevent the spread of bacteria between patients. Dr. Peter Pronovost, who participated in the telebriefing, said that he and his associates at Johns Hopkins University in Baltimore “do this by practicing good hand hygiene techniques by wearing sterile equipment when inserting lines.”
• Prevent surgery-related infections and/or placement of a catheter. “Check catheters frequently and remove them when you no longer need them,” advised Dr. Pronovost, director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins. “Ask if you actually need them before you even place them.”
• Improve antibiotic use through stewardship. This means using “the right antibiotics for the right duration,” Dr. Pronovost said. “Antibiotics could be lifesaving and are necessary for critically ill patients, especially those with septic shock. But these antibiotics need to be adjusted based on lab results and new information about the organisms that are causing these infections. Forty-eight hours after antibiotics are initiated, take a ‘time out.’ Perform a brief but focused assessment to determine if antibiotic therapy is still needed, or if it should be refined. A common mistake we make is to continue vancomycin when there is no presence of MRSA. We often tell our staff at Johns Hopkins, ‘if it doesn’t grow, let it go.’ ”
Dr. Frieden concluded his remarks by noting that physicians and other clinicians on the front lines “need support of their facility leadership,” to prevent HAIs. “Health care facilities, CEOs, and administrators are a major part of the solution. It’s important that they make a priority of infection prevention, sepsis prevention, and antibiotic stewardship. Know your facility’s data and target prevention efforts to ensure improvements in patient safety.”
FROM MMWR
Safety of bioresorbable stents does not match that of metal stents
Bioresorbable vascular scaffold stents are improving rapidly but they are still associated with a higher risk of complications compared with drug-eluting metal stents, according to a meta-analysis of published studies presented at Cardiovascular Research Technologies 2016.
“Bioresorbable stents are clearly an attractive strategy, but our data suggest that physicians and patients should remain aware of the risks,” reported Dr. Alok Saurav of Creighton University Medical Center, Omaha, Neb.
The first bioresorbable vascular scaffold (BVS) device, Synergy, was approved this past October, but this stent, despite bioresorbable struts, still has body parts that are not fully bioresorbable. However, several fully bioresorbable devices have reached late stages of testing and may receive regulatory approval this year.
In the meta-analysis, eight studies – five randomized trials, two studies with propensity matching, and an observational study –the primary goal was to compare BVS to drug eluting metal (DEM) stents for definite stent thrombosis. Secondary outcomes included subacute stent thrombosis within 30 days and within 1 year and cardiac death, all-cause death, MI, and ischemia-driven target vessel revascularization (TVR).
Despite the fact that the mean age and gender distribution was the same when the 2,760 patients receiving BVS stents were compared to the 2,212 receiving DEM stents, and both received comparable antiplatelet regimens after the stent was placed, there was an 80% greater relative risk for definite stent thrombosis in the BVS group. Although this difference fell short of statistical significance (P = .06), Dr. Saurav called it a “strong trend.”
Several of the adverse events that were analyzed as secondary outcomes in this study were less frequent with the BVS, such as cardiac death (relative risk, 0.83) and all-cause death (RR, 0.74), but the statistics did not suggest a trend, so Dr. Saurav characterized these outcomes as similar. MI was an exception. This was more frequent in those received a BVS stent (RR, 1.35; P = .049), and this reached significance.
Most of the studies included in this analysis were conducted with the everolimus-eluting Absorb BVS device, which many are predicting will be the first fully bioresorbable stent to receive regulatory approval.
It is notable that another meta-analysis including some of the same studies and published just weeks prior to the CRT meeting drew the same conclusion about the increased risk of stent thrombosis with BVS relative to DEM stents (Lancet 2016;387:537-44). This meta-analysis was restricted to six trials with 3,738 randomized patients. Unlike the meta-analysis presented at CRT, this study compared the two types of stents for both definite and probable stent thrombosis. For BVS relative to DEM stents, the relative risk for this outcome was 1.99 (P = .05).
“We think our restriction to definite stent thrombosis provides a stricter endpoint, but it’s notable that the results were relatively consistent,” Dr. Saurav reported.
Acknowledging that the increased risk of stent thrombosis appears to be modest for BVS relative to DEM stents, Dr. Saurav emphasized that these data should not discourage further development of bioresorbable stents, which are conceptually attractive.
“We cannot take these bioresorbable devices off the table,” he said. “But we do need more data to evaluate their risks relative to the conventional devices that are now available.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Saurav reported no conflicts of interest.
Bioresorbable vascular scaffold stents are improving rapidly but they are still associated with a higher risk of complications compared with drug-eluting metal stents, according to a meta-analysis of published studies presented at Cardiovascular Research Technologies 2016.
“Bioresorbable stents are clearly an attractive strategy, but our data suggest that physicians and patients should remain aware of the risks,” reported Dr. Alok Saurav of Creighton University Medical Center, Omaha, Neb.
The first bioresorbable vascular scaffold (BVS) device, Synergy, was approved this past October, but this stent, despite bioresorbable struts, still has body parts that are not fully bioresorbable. However, several fully bioresorbable devices have reached late stages of testing and may receive regulatory approval this year.
In the meta-analysis, eight studies – five randomized trials, two studies with propensity matching, and an observational study –the primary goal was to compare BVS to drug eluting metal (DEM) stents for definite stent thrombosis. Secondary outcomes included subacute stent thrombosis within 30 days and within 1 year and cardiac death, all-cause death, MI, and ischemia-driven target vessel revascularization (TVR).
Despite the fact that the mean age and gender distribution was the same when the 2,760 patients receiving BVS stents were compared to the 2,212 receiving DEM stents, and both received comparable antiplatelet regimens after the stent was placed, there was an 80% greater relative risk for definite stent thrombosis in the BVS group. Although this difference fell short of statistical significance (P = .06), Dr. Saurav called it a “strong trend.”
Several of the adverse events that were analyzed as secondary outcomes in this study were less frequent with the BVS, such as cardiac death (relative risk, 0.83) and all-cause death (RR, 0.74), but the statistics did not suggest a trend, so Dr. Saurav characterized these outcomes as similar. MI was an exception. This was more frequent in those received a BVS stent (RR, 1.35; P = .049), and this reached significance.
Most of the studies included in this analysis were conducted with the everolimus-eluting Absorb BVS device, which many are predicting will be the first fully bioresorbable stent to receive regulatory approval.
It is notable that another meta-analysis including some of the same studies and published just weeks prior to the CRT meeting drew the same conclusion about the increased risk of stent thrombosis with BVS relative to DEM stents (Lancet 2016;387:537-44). This meta-analysis was restricted to six trials with 3,738 randomized patients. Unlike the meta-analysis presented at CRT, this study compared the two types of stents for both definite and probable stent thrombosis. For BVS relative to DEM stents, the relative risk for this outcome was 1.99 (P = .05).
“We think our restriction to definite stent thrombosis provides a stricter endpoint, but it’s notable that the results were relatively consistent,” Dr. Saurav reported.
Acknowledging that the increased risk of stent thrombosis appears to be modest for BVS relative to DEM stents, Dr. Saurav emphasized that these data should not discourage further development of bioresorbable stents, which are conceptually attractive.
“We cannot take these bioresorbable devices off the table,” he said. “But we do need more data to evaluate their risks relative to the conventional devices that are now available.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Saurav reported no conflicts of interest.
Bioresorbable vascular scaffold stents are improving rapidly but they are still associated with a higher risk of complications compared with drug-eluting metal stents, according to a meta-analysis of published studies presented at Cardiovascular Research Technologies 2016.
“Bioresorbable stents are clearly an attractive strategy, but our data suggest that physicians and patients should remain aware of the risks,” reported Dr. Alok Saurav of Creighton University Medical Center, Omaha, Neb.
The first bioresorbable vascular scaffold (BVS) device, Synergy, was approved this past October, but this stent, despite bioresorbable struts, still has body parts that are not fully bioresorbable. However, several fully bioresorbable devices have reached late stages of testing and may receive regulatory approval this year.
In the meta-analysis, eight studies – five randomized trials, two studies with propensity matching, and an observational study –the primary goal was to compare BVS to drug eluting metal (DEM) stents for definite stent thrombosis. Secondary outcomes included subacute stent thrombosis within 30 days and within 1 year and cardiac death, all-cause death, MI, and ischemia-driven target vessel revascularization (TVR).
Despite the fact that the mean age and gender distribution was the same when the 2,760 patients receiving BVS stents were compared to the 2,212 receiving DEM stents, and both received comparable antiplatelet regimens after the stent was placed, there was an 80% greater relative risk for definite stent thrombosis in the BVS group. Although this difference fell short of statistical significance (P = .06), Dr. Saurav called it a “strong trend.”
Several of the adverse events that were analyzed as secondary outcomes in this study were less frequent with the BVS, such as cardiac death (relative risk, 0.83) and all-cause death (RR, 0.74), but the statistics did not suggest a trend, so Dr. Saurav characterized these outcomes as similar. MI was an exception. This was more frequent in those received a BVS stent (RR, 1.35; P = .049), and this reached significance.
Most of the studies included in this analysis were conducted with the everolimus-eluting Absorb BVS device, which many are predicting will be the first fully bioresorbable stent to receive regulatory approval.
It is notable that another meta-analysis including some of the same studies and published just weeks prior to the CRT meeting drew the same conclusion about the increased risk of stent thrombosis with BVS relative to DEM stents (Lancet 2016;387:537-44). This meta-analysis was restricted to six trials with 3,738 randomized patients. Unlike the meta-analysis presented at CRT, this study compared the two types of stents for both definite and probable stent thrombosis. For BVS relative to DEM stents, the relative risk for this outcome was 1.99 (P = .05).
“We think our restriction to definite stent thrombosis provides a stricter endpoint, but it’s notable that the results were relatively consistent,” Dr. Saurav reported.
Acknowledging that the increased risk of stent thrombosis appears to be modest for BVS relative to DEM stents, Dr. Saurav emphasized that these data should not discourage further development of bioresorbable stents, which are conceptually attractive.
“We cannot take these bioresorbable devices off the table,” he said. “But we do need more data to evaluate their risks relative to the conventional devices that are now available.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Saurav reported no conflicts of interest.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: Trial data suggest the risk of thrombosis and other adverse events remains higher with bioresorbable stents than with conventional drug-eluting metal stents.
Major finding: In a meta-analysis, the 80% increased risk of definite stent thrombosis for bioresorbable relative to metal stents fell just short of significance (P = .06) but the 35% increased risk of subsequent MI was significant (P = .049).
Data source: Meta-analysis of eight studies.
Disclosures: Dr. Saurav reported no conflicts of interest.
Pro basketball players’ hearts: LV keeps growing, aortic root doesn’t
For the first time, cardiologists have characterized the adaptive cardiac remodeling in a large cohort of National Basketball Association players, which establishes a normative database and allows physicians to distinguish it from occult pathologic changes that may precipitate sudden cardiac death, according to an imaging study.
“We hope that the present data will help to focus decision making and improve clinical acumen for the purpose of primary prevention of cardiac emergencies in U.S. basketball players and in the athletic community at large,” said Dr. David J. Engel and his associates of Columbia University, New York.
Until now, most of the literature concerning the structural features of the athletic heart has been based on European studies, where comprehensive cardiac screening of all elite athletes is mandatory. The typical sports activities and the demographics of athletes in the U.S. are different, and their cardiologic profiles have not been well studied because detailed cardiac examinations are not compulsory. But the NBA recently mandated that all athletes undergo annual preseason medical evaluations including stress echocardiograms, and allowed the division of cardiology at Columbia to assess the results each year.
“A detailed understanding of normal and expected cardiac remodeling in U.S. basketball players has significant clinical importance given that the incidence of sports-related sudden cardiac death in the U.S. is highest among basketball players and that the most common cause ... in this population is hypertrophic cardiomyopathy,” the investigators noted.
Their analysis of all 526 ECGs performed on NBA players during a 1-year period “will provide an invaluable frame of reference to enhance player safety for the large group of U.S. basketball players in training at all skill levels, and in the athletic community at large,” they said.
The study participants were aged 18-39 years (mean age, 25.7 years). Roughly 77% were African American, 20% were white, 2% were Hispanic, and 1% were Asian or other ethnicities. The mean height was 200.2 cm (6’7”).
Left ventricular cavity size was larger than that in the general population, but LV size was proportional to the athletes’ large body size. “Scaling LV size to body size is vitally important in the cardiac evaluation of basketball players, whose heights extend to 218 cm and body surface areas to 2.8 m2,” Dr. Engel and his associates said (JAMA Cardiol. 2016 Feb 24. doi: 10.1001/jamacardio.2015.0252).
Left ventricular hypertrophy (LVH) was identified in only 27% of the athletes. African Americans had increased indices of LVH, compared with whites, and had a higher incidence of nondilated concentric hypertrophy, while whites showed predominantly eccentric dilated hypertrophy. These findings should help clinicians recognize genuine hypertrophic cardiomyopathy, which is a contraindication to participating in all but the most low-intensity competitive sports.
Most of the participants had a normal left ventricular ejection fraction, and all showed normal augmentation of LV systolic function with exercise.
Aortic root diameter was larger than that in the general population but similar to that in other elite athletes. Surprisingly, aortic root diameter increased with increasing body size only to a certain point, reaching a plateau at 31-35 mm. Fewer than 5% of the participants had an aortic root diameter of 40 mm or more, and the maximal diameter was 42 mm. “These data have important implications in the evaluation of exceptionally large athletes and question the applicability in individuals with significantly increased biometrics of the traditional formula to estimate aortic root diameter that assumes a linear association between [it] and body surface area,” they noted.
“We hope that the results of this study will assist recognition of cardiac pathologic change and provide a framework to help avoid unnecessary exclusions of athletes from competition. We believe that these data have additional applicability to other sports that preselect for athletes with height, such as volleyball, rowing, and track and field,” Dr. Engel and his associates added.
This study was supported by the National Basketball Association as part of a medical services agreement with Columbia University. Dr. Engel and his associates reported having no relevant financial disclosures.
The most interesting finding of this study was that despite the immense body size of the athletes, aortic root diameter exceeded 40 mm in less than 5%, and when dilation did occur it was of a very small magnitude, with a maximal diameter of 42 mm.
This important finding confirms that only mild aortic dilation should be considered physiologic among athletes, and that even athletes at the extreme end of the height spectrum should not be expected to show proportionally extreme aortic dilation.
Unlike ventricular size, which increases proportionally with body size, aortic dilation has an upper limit. Athletes with aortic dimensions that exceed this limit should be considered at risk for aortopathy and either prohibited from competitive sports or closely monitored if they do participate.
Dr. Aaron L. Baggish of the Cardiovascular Performance Program at Massachusetts General Hospital, Boston, made these remarks in an accompanying editorial (JAMA Cardiol. 2016 Feb 24. doi: 10.1001/jamacardio.2015.0289). He reported having no relevant financial conflicts of interest.
The most interesting finding of this study was that despite the immense body size of the athletes, aortic root diameter exceeded 40 mm in less than 5%, and when dilation did occur it was of a very small magnitude, with a maximal diameter of 42 mm.
This important finding confirms that only mild aortic dilation should be considered physiologic among athletes, and that even athletes at the extreme end of the height spectrum should not be expected to show proportionally extreme aortic dilation.
Unlike ventricular size, which increases proportionally with body size, aortic dilation has an upper limit. Athletes with aortic dimensions that exceed this limit should be considered at risk for aortopathy and either prohibited from competitive sports or closely monitored if they do participate.
Dr. Aaron L. Baggish of the Cardiovascular Performance Program at Massachusetts General Hospital, Boston, made these remarks in an accompanying editorial (JAMA Cardiol. 2016 Feb 24. doi: 10.1001/jamacardio.2015.0289). He reported having no relevant financial conflicts of interest.
The most interesting finding of this study was that despite the immense body size of the athletes, aortic root diameter exceeded 40 mm in less than 5%, and when dilation did occur it was of a very small magnitude, with a maximal diameter of 42 mm.
This important finding confirms that only mild aortic dilation should be considered physiologic among athletes, and that even athletes at the extreme end of the height spectrum should not be expected to show proportionally extreme aortic dilation.
Unlike ventricular size, which increases proportionally with body size, aortic dilation has an upper limit. Athletes with aortic dimensions that exceed this limit should be considered at risk for aortopathy and either prohibited from competitive sports or closely monitored if they do participate.
Dr. Aaron L. Baggish of the Cardiovascular Performance Program at Massachusetts General Hospital, Boston, made these remarks in an accompanying editorial (JAMA Cardiol. 2016 Feb 24. doi: 10.1001/jamacardio.2015.0289). He reported having no relevant financial conflicts of interest.
For the first time, cardiologists have characterized the adaptive cardiac remodeling in a large cohort of National Basketball Association players, which establishes a normative database and allows physicians to distinguish it from occult pathologic changes that may precipitate sudden cardiac death, according to an imaging study.
“We hope that the present data will help to focus decision making and improve clinical acumen for the purpose of primary prevention of cardiac emergencies in U.S. basketball players and in the athletic community at large,” said Dr. David J. Engel and his associates of Columbia University, New York.
Until now, most of the literature concerning the structural features of the athletic heart has been based on European studies, where comprehensive cardiac screening of all elite athletes is mandatory. The typical sports activities and the demographics of athletes in the U.S. are different, and their cardiologic profiles have not been well studied because detailed cardiac examinations are not compulsory. But the NBA recently mandated that all athletes undergo annual preseason medical evaluations including stress echocardiograms, and allowed the division of cardiology at Columbia to assess the results each year.
“A detailed understanding of normal and expected cardiac remodeling in U.S. basketball players has significant clinical importance given that the incidence of sports-related sudden cardiac death in the U.S. is highest among basketball players and that the most common cause ... in this population is hypertrophic cardiomyopathy,” the investigators noted.
Their analysis of all 526 ECGs performed on NBA players during a 1-year period “will provide an invaluable frame of reference to enhance player safety for the large group of U.S. basketball players in training at all skill levels, and in the athletic community at large,” they said.
The study participants were aged 18-39 years (mean age, 25.7 years). Roughly 77% were African American, 20% were white, 2% were Hispanic, and 1% were Asian or other ethnicities. The mean height was 200.2 cm (6’7”).
Left ventricular cavity size was larger than that in the general population, but LV size was proportional to the athletes’ large body size. “Scaling LV size to body size is vitally important in the cardiac evaluation of basketball players, whose heights extend to 218 cm and body surface areas to 2.8 m2,” Dr. Engel and his associates said (JAMA Cardiol. 2016 Feb 24. doi: 10.1001/jamacardio.2015.0252).
Left ventricular hypertrophy (LVH) was identified in only 27% of the athletes. African Americans had increased indices of LVH, compared with whites, and had a higher incidence of nondilated concentric hypertrophy, while whites showed predominantly eccentric dilated hypertrophy. These findings should help clinicians recognize genuine hypertrophic cardiomyopathy, which is a contraindication to participating in all but the most low-intensity competitive sports.
Most of the participants had a normal left ventricular ejection fraction, and all showed normal augmentation of LV systolic function with exercise.
Aortic root diameter was larger than that in the general population but similar to that in other elite athletes. Surprisingly, aortic root diameter increased with increasing body size only to a certain point, reaching a plateau at 31-35 mm. Fewer than 5% of the participants had an aortic root diameter of 40 mm or more, and the maximal diameter was 42 mm. “These data have important implications in the evaluation of exceptionally large athletes and question the applicability in individuals with significantly increased biometrics of the traditional formula to estimate aortic root diameter that assumes a linear association between [it] and body surface area,” they noted.
“We hope that the results of this study will assist recognition of cardiac pathologic change and provide a framework to help avoid unnecessary exclusions of athletes from competition. We believe that these data have additional applicability to other sports that preselect for athletes with height, such as volleyball, rowing, and track and field,” Dr. Engel and his associates added.
This study was supported by the National Basketball Association as part of a medical services agreement with Columbia University. Dr. Engel and his associates reported having no relevant financial disclosures.
For the first time, cardiologists have characterized the adaptive cardiac remodeling in a large cohort of National Basketball Association players, which establishes a normative database and allows physicians to distinguish it from occult pathologic changes that may precipitate sudden cardiac death, according to an imaging study.
“We hope that the present data will help to focus decision making and improve clinical acumen for the purpose of primary prevention of cardiac emergencies in U.S. basketball players and in the athletic community at large,” said Dr. David J. Engel and his associates of Columbia University, New York.
Until now, most of the literature concerning the structural features of the athletic heart has been based on European studies, where comprehensive cardiac screening of all elite athletes is mandatory. The typical sports activities and the demographics of athletes in the U.S. are different, and their cardiologic profiles have not been well studied because detailed cardiac examinations are not compulsory. But the NBA recently mandated that all athletes undergo annual preseason medical evaluations including stress echocardiograms, and allowed the division of cardiology at Columbia to assess the results each year.
“A detailed understanding of normal and expected cardiac remodeling in U.S. basketball players has significant clinical importance given that the incidence of sports-related sudden cardiac death in the U.S. is highest among basketball players and that the most common cause ... in this population is hypertrophic cardiomyopathy,” the investigators noted.
Their analysis of all 526 ECGs performed on NBA players during a 1-year period “will provide an invaluable frame of reference to enhance player safety for the large group of U.S. basketball players in training at all skill levels, and in the athletic community at large,” they said.
The study participants were aged 18-39 years (mean age, 25.7 years). Roughly 77% were African American, 20% were white, 2% were Hispanic, and 1% were Asian or other ethnicities. The mean height was 200.2 cm (6’7”).
Left ventricular cavity size was larger than that in the general population, but LV size was proportional to the athletes’ large body size. “Scaling LV size to body size is vitally important in the cardiac evaluation of basketball players, whose heights extend to 218 cm and body surface areas to 2.8 m2,” Dr. Engel and his associates said (JAMA Cardiol. 2016 Feb 24. doi: 10.1001/jamacardio.2015.0252).
Left ventricular hypertrophy (LVH) was identified in only 27% of the athletes. African Americans had increased indices of LVH, compared with whites, and had a higher incidence of nondilated concentric hypertrophy, while whites showed predominantly eccentric dilated hypertrophy. These findings should help clinicians recognize genuine hypertrophic cardiomyopathy, which is a contraindication to participating in all but the most low-intensity competitive sports.
Most of the participants had a normal left ventricular ejection fraction, and all showed normal augmentation of LV systolic function with exercise.
Aortic root diameter was larger than that in the general population but similar to that in other elite athletes. Surprisingly, aortic root diameter increased with increasing body size only to a certain point, reaching a plateau at 31-35 mm. Fewer than 5% of the participants had an aortic root diameter of 40 mm or more, and the maximal diameter was 42 mm. “These data have important implications in the evaluation of exceptionally large athletes and question the applicability in individuals with significantly increased biometrics of the traditional formula to estimate aortic root diameter that assumes a linear association between [it] and body surface area,” they noted.
“We hope that the results of this study will assist recognition of cardiac pathologic change and provide a framework to help avoid unnecessary exclusions of athletes from competition. We believe that these data have additional applicability to other sports that preselect for athletes with height, such as volleyball, rowing, and track and field,” Dr. Engel and his associates added.
This study was supported by the National Basketball Association as part of a medical services agreement with Columbia University. Dr. Engel and his associates reported having no relevant financial disclosures.
FROM JAMA CARDIOLOGY
Key clinical point: Cardiologists characterized normal, adaptive cardiac remodeling in NBA players, allowing physicians to distinguish it from occult pathologic changes that may precipitate sudden cardiac death.
Major finding: Aortic root diameter increased with increasing body size only to a certain point, reaching a plateau at 31-35 mm.
Data source: An observational cohort study in which echocardiograms of 526 professional athletes were analyzed.
Disclosures: This study was supported by the National Basketball Association as part of a medical services agreement with Columbia University. Dr. Engel and his associates reported having no relevant financial disclosures.
NSQIP calculator shown inadequate to stratify risk in stage I non–small cell lung cancer.
A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
In their reported study, Dr. Samson and her colleagues found that the NSQIP tool underestimated morbidity. They also found that risk predicted by the NSQIP tool was not necessarily aligned with their institution’s actual treatment selection for stage I NSCLC, which they based upon a number of factors. “This study potentially has important clinical implications,” according to Dr. Xiaofei Wang and Dr. Mark F. Berry in their invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:706-7). “This present study shows that even a robust, well-managed tool from the NSQIP does not adequately stratify surgical risk... Their analysis implies that the treatment decision made by the institutional clinicians is optimal.”
“The lackluster performance of the NSQIP score is understandable, because it was not designed to optimally differentiate patients who benefited most from surgery or SBRT. Randomized clinical trials or well-controlled prospective observations are needed to develop and validate specific predictive tools for optimal treatment selection. These models must consider not only treatment morbidity, but also the cost of possible recurrence with each therapy,” Dr. Wang and Dr. Berry stated.
“Perhaps the most important conclusion that can be drawn from this present study is that current risk assessment tools can be helpful, but cannot replace evaluation by clinicians for whom all management options are available when therapy is chosen for a specific patient,” they concluded.
Dr. Wang is from the department of biostatistics and bioinformatics at Duke University, Durham, N.C., and Dr. Berry is from the department of cardiothoracic surgery, Stanford University, Stanford, Calif. They had no relevant financial disclosures.
A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
A study performed to validate the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator for use in patients receiving surgery or stereotactic body radiation therapy (SBRT) for stage I non–small cell lung cancer showed the calculator to be inadequate for both classification and risk stratification. The study was reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151;697-705).
Dr. Pamela Samson of Washington University in St. Louis and her colleagues performed a retrospective analysis of 485 patients with clinical stage I NSCLC who underwent either surgery (277) or SBRT (195) from 2009 to 2012. Surgery was either wedge resection (19.3%) or lobectomy (74.5%), with smaller percentages receiving segmentectomy (4.0%), pneumonectomy (1.5%), and bilobectomy (0.7%). A large majority of surgical patients (84.1%) underwent a video-assisted thoracoscopic surgery (VATS) approach.
The researchers calculated NSQIP complication risk estimates for both surgical and SBRT patients using the NSQIP Surgical Risk Calculator. They compared predicted risk with actual adverse events.
Compared with patients undergoing VATS wedge resection, patients receiving SBRT were older, had larger tumors, lower forced expiratory volume (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO), higher American Society of Anesthesiologist scores, higher rates of dyspnea and higher NSQIP serious complication risk estimates, all significant at P less than .05. Similar disparities were seen in comparing patients receiving SBRT vs. VATS lobectomy.
The actual serious complication rate for surgical patients was significantly higher than the NSQIP risk calculator prediction (16.6% vs. 8.8%), as was the rate of pneumonia (6.0% vs. 3.2%), both at P less than .05.
Overall, the NSQIP Surgical Risk Calculator provided a fair level of discrimination between VATS lobectomy and SBRT on receiver operating characteristic (ROC) curve analysis, but it was a poor model for differentiating between VATS wedge resection and SBRT. “Unfortunately, it is this latter population of the highest risk surgical patients (for whom a lobectomy is not a surgical option) where risk models and decision aids are needed most,” Dr. Samson and her colleagues stated.
“Counseling the high-risk but operable patient with clinical stage I NSCLC in regard to lobectomy, sublobar resection, or SBRT is challenging for both the clinician and the patient,” according to the researchers. “We believe that a model tailored to patients with clinical stage I needs to serve as both an estimator of operative risks and a patient decision aid for surgery versus SBRT, especially with projected increases in the number of early-stage lung cancers as a result of increased lung cancer screening efforts,” they added.
“Our analysis suggests that the NSQIP Surgical Risk Calculator likely does not profile the risk of a patient with lung cancer closely enough to dichotomize surgical and inoperable SBRT cases (especially when patients are being considered for a wedge resection) or adequately estimate a surgical patient’s risk of serious complications,” Dr. Samson and her colleagues concluded.
The study was supported by grants from National Institutes of Health. The authors had no relevant financial disclosures.
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: The current NSQIP Surgical Risk Calculator does not adequately estimate risk among patients with clinical stage I non–small cell lung cancer.
Major finding: The NSQIP risk calculator significantly underestimated serious complication risk in operative patients (16.6% actual risk vs. 8.8% predicted) and did not adequately stratify risk between surgical and stereotactic body radiation therapy (SBRT) patients.
Data source: Researchers retrospectively assessed 279 NSCLC stage I lung cancer patients who underwent surgery vs. 206 patients who underwent SBRT from 2009 to 2012.
Disclosures: The study was supported by grants from the National Institutes of Health. The authors had no relevant financial disclosures.
MRI assessment of pulmonary vein stenosis predicts outcomes
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
|
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
|
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
“The Toronto group has contributed significantly to our knowledge and management of pulmonary vein stenosis during the past decade. This article by Dr. Lo Rito and coworkers continues that contribution by reinforcing the values of MRI in imaging PVs before intervention and providing a valuable “hint” that preoperative PV size measurements are related to outcome,” Dr. William M. DeCampli wrote in his invited commentary (J Thorac Cardiovasc Surg. 2016;1510:667-8).
“The task of definitively demonstrating this relationship is daunting for any single institution, however, because 1) PVS is relatively rare, 2) MRI and computed tomography are relatively recently used diagnostic modalities, and 3) MRI is not easily used in an important subset of the cohort, small infants.” This limited the study to a small number of covariates,” noted Dr. DeCampli, and prevented the researchers from taking into account a myriad of additional covariates commonly associated with survival in complex congenital heart disease.
|
Dr. William M. DeCampli |
Such covariates included in a sufficiently large model could significantly alter the observed odds ratios otherwise calculated for the included variables in this study, he added, citing a study of PVS by Boston Children’s Hospital (J Thorac Cardiovasc Surg. 2015;150:911-7), which found a different set of covariates associated with death; in that case, age younger than 6 months at operation, weight less than 3 kg at operation, and lesser preoperative right ventricular systolic pressure.
“The challenges in studying PVS encountered by these two high-volume, research-oriented programs leads us to suggest that PVS should be studied in a different way. Perhaps it is time to consider a multi-institutional, mixed or inception cohort registry for PVS. The spring 2015 Society of Thoracic Surgeons Congenital Heart Database report lists 506 cases of PVS repair as the primary procedure between January 2011 and December 2014. If a study were to enroll just one-third of these subjects it would accrue more than 40 subjects per year. Five years hence with an anticipated 50-80 events (deaths), it would be possible to carry out more robust risk-hazard analyses,” Dr. DeCampli suggested.
Dr. DeCampli is a congenital heart surgeon at the department of clinical sciences, University of Central Florida, and the Heart Center at Arnold Palmer Hospital for Children, both in Orlando. He reported having no conflicts.
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
A retrospective analysis of children who underwent pulmonary vein stenosis repair with preoperative computed tomography and magnetic resonance imaging from 1990 to 2012 showed that smaller upstream or downstream total cross-sectional area indexed (TCSAi) for body surface area led to poorer survival.
The study of 31 patients at a single institution also indicated that early survival seemed especially poor for patients with a greater number of stenotic veins and upstream pulmonary vein (PV) involvement. The study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery.
Dr. Mauro Lo Rito and his colleagues at The Hospital for Sick Children, Toronto, retrospectively assessed the 31 patients out of 145 who underwent surgical repair who had had preoperative CT and MRI imaging. Complete sutureless repair was done in 18 (58%), single-side sutureless repair in 12 (39%), and pericardial patch reconstruction in 1 (3%). The mean follow-up was 4.3 years; the median patient age at time of operation was 226 days. Stenosis was bilateral in 45% of patients and unilateral in 55 (J Thorac Cardiovasc Surg. 2016;151:657-66).
In-hospital mortality was 9.7%, with an overall survival of 75%, 69%, and 64% at 1, 3, and 5 years, respectively. Univariate analysis showed that a younger age at operation, lower body surface area, smaller upstream TCSAi, and greater number of PV with stenosis/occlusion were associated with an increased risk of death.
Multivariate analysis showed that smaller upstream TCSAi for body surface area (P = .030) and greater number of stenotic PVs (P = .007) were associated with poor early (less than 1 year) survival. There was a nonsignificant tendency for smaller downstream TCSAi to be associated with poor late survival (greater than 1 year). None of the different PV morphologies were found to influence survival, according to Dr. Lo Rito and his colleagues.
Among the 28 hospital survivors, restenosis occurred in 10 patients, 7 of whom did not undergo further surgery (3 of these were alive at last follow-up and 4 died secondary to disease progression). Of the 3 patients who underwent subsequent intervention, 2 were alive at last follow-up.
“Risk stratification for patients with PV stenosis is currently challenging because of the variability in the anatomic configuration and the unknown relationship between these anatomic variants and survival. Our study demonstrates that by using cross-sectional areas, pulmonary vein cross-sectional area indexed to body surface area (PVCSAi) and TCSAi and tabulating the number of stenotic PVs, we can identify high-risk subsets of patients with high predicted mortality.” Dr. Lo Rito and his colleagues stated.
“The upstream total cross-sectional area and the number of stenotic PVs influence early survival and can be used to guide counseling. Smaller downstream cross-sectional area influences late survival, and those patients should be monitored with close follow-up. This methodology could aid in risk stratification for future clinical trials of pharmacologic agents designed to target upstream pulmonary vasculopathy,” the investigators concluded.
The authors reported that they had no conflicts of interest.
A webcast of the original presentation of these results at the 95th American Association for Thoracic Surgery Annual Meeting is available online (http://webcast.aats.org/2015/Video/Tuesday/04-28-15_6A_1615_Lo_Rito.mp4).
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Survival after pulmonary vein stenosis repair was adversely affected by smaller upstream cross-sectional area indexed to body surface area.
Major finding: Smaller upstream total cross-sectional area indexed for body surface area (P = .30) and greater number of stenotic pulmonary veins (P = .007) were associated with increased early risk of death.
Data source: Researchers reviewed the outcomes of 31/145 patients who underwent surgical repair of pulmonary stenosis who had preoperative computed tomography and magnetic resonance imaging between 1990 and 2012.
Disclosures: The authors reported that they had no conflicts of interest.
Exciting Program Set for AATS Week 2016, Register Today!
Be a part of an extraordinary week of science, sharing the latest advances in cardiothoracic surgery with colleagues from around the world -- AATS Week 2016. The week starts off with the two-day Aortic Symposium (May 12–13/New York City) followed by the 96th AATS Annual Meeting (May 14-18/Baltimore, MD). Register now!
Be a part of an extraordinary week of science, sharing the latest advances in cardiothoracic surgery with colleagues from around the world -- AATS Week 2016. The week starts off with the two-day Aortic Symposium (May 12–13/New York City) followed by the 96th AATS Annual Meeting (May 14-18/Baltimore, MD). Register now!
Be a part of an extraordinary week of science, sharing the latest advances in cardiothoracic surgery with colleagues from around the world -- AATS Week 2016. The week starts off with the two-day Aortic Symposium (May 12–13/New York City) followed by the 96th AATS Annual Meeting (May 14-18/Baltimore, MD). Register now!
STS: Valved conduit shows right ventricular outflow durability
PHOENIX – A prosthetic conduit that contains a porcine valve showed excellent intermediate-term durability for repairing the right ventricular outflow tract in 100 teenagers and young adults at a single U.S. center.
“The Carpentier-Edwards xenograft for right ventricular outflow tract [RVOT] reconstruction provides excellent freedom from reoperation and valve dysfunction, as well as sustained improvement in right-ventricular chamber size at intermediate-term follow-up,” Dr. Heidi B. Schubmehl said at the Society of Thoracic Surgeons annual meeting.
Dr. Schubmehl reported a 92% rate of freedom from valve dysfunction with follow-up out to about 10 years, and significant reductions in right ventricular size at follow-up, compared with baseline, as measured by both echocardiography and by MRI.
The Carpentier-Edwards porcine valve and conduit “seemed to hold up better than a lot of other [prosthetic] valves,” said Dr. George M. Alfieris, director of pediatric cardiac surgery at the University of Rochester (N.Y.), and senior author for the study. In addition to the valve’s durability over approximately the first 10 years following placement, the results also showed the positive impact the valve had on right ventricular size, an important result of the repair’s efficacy, Dr. Alfieris said.
“It’s a mistake to allow the right ventricle to be under high pressure or to reach a large volume. We now focus on preserving the right ventricle,” he said in an interview. “I’ve become very concerned about preventing right ventricular dilation and preserving right ventricular function.”
Dr. Alfieris noted that his prior experience using other types of valves in the pulmonary valve and RVOT position showed those valves “did great for the first 10 years and then failed. What’s different in this series is that after 10 years, we have not seen the same dysfunction as with the prior generation of valves. I will be very interested to see what happens to them” as follow-up continues beyond 10 years. He also expressed dismay that recently the company that had been marketing the valve and conduit used in the current study, the Carpentier-Edwards, stopped selling them. He expects that as his supply of conduits runs out he’ll have to start using a different commercial valve and conduit that he believes will not perform as well or create his own conduits with a porcine valve from a different supplier.
The series of 100 patients comprised individuals aged 17 or older who received a pulmonary artery and had RVOT reconstruction at the University of Rochester during 2000-2010, Dr. Schubmehl reported. The series included 78 patients with a history of tetralogy of Fallot, 8 patients born with transposition of their great arteries, 8 patients with truncus arteriosus, and 6 patients with other congenital heart diseases. Their median age at the time they received the RVOT conduit was 24 years, 59% were men, and 99 had undergone a prior sternotomy. At the time they received the conduit, 55 had pulmonary valve insufficiency, 30 had valve stenosis, and 15 had both. Follow-up occurred an average of 7 years after conduit placement.
Two recipients died: One death occurred perioperatively in a 41-year old who had a massive cerebrovascular event, and the second death was in a 39-year old who died 2.6 years after conduit placement from respiratory failure. Two additional patients required a reintervention during follow-up, said Dr. Schubmehl, a general surgeon at the University of Rochester. One reintervention occurred after 11 years to treat endocarditis, and the second after 11 years to perform balloon valvuloplasty because of valve stenosis.
The results reported by Dr. Schubmehl for echocardiography examinations showed that the patients had a statistically significant reduction in their RVOT pressure gradient from baseline to 1-year follow-up that was sustained through their intermediate-term follow-up. Seventy-seven patients had pulmonary valve insufficiency at baseline that resolved in all patients at 1-year follow-up and remained resolved in all but one patient at extended follow-up. Nineteen patients underwent additional imaging with MRI at an average follow-up of 7 years, and these findings confirmed the echo results.
On Twitter @mitchelzoler
The intermediate-term results reported by Dr. Schubmehl using a Carpentier-Edwards conduit in the right-ventricular outflow tract are clearly better than what we have seen using other types of valves and conduits in this position. If the valve and conduit they used persists with similar performance beyond 10 years, it would be a very good option. However, what typically happens is that replacement valves look good for about 10 years and then start to fail, often with a steep failure curve. I suspect that during the next 10 years of follow-up many more of the valves they placed will start to fail. The 10- to 20-year follow-up period is critical for demonstrating long-term durability of this valve and conduit.
|
Dr. James Jaggers |
One additional potential advantage of the Carpentier-Edwards prosthesis is that the valve it contains is larger than the usual valve placed in the right ventricular outflow tract (RVOT). Failed valves increasingly are replaced by a transcatheter approach that puts a new valve inside the old, failed valve. As patients who received these replacement valves continue to survive we anticipate their need over time for a series of valve-in-valve procedures. The larger the valve at the outset, the more feasible it will be to have multiple episodes of valve-in-valve replacement.
At one time, we regarded early surgical repair of a tetralogy of Fallot defect as curative. We now know that as children with a repaired tetralogy of Fallot grow into teens and adults they require additional repairs, most often replacement of their RVOTs. This has made pulmonary valve replacement the most common surgery for adult survivors of congenital heart disease. The numbers of teen or adult patients who require a new RVOT will steadily increase as more of these children survive.
Dr. James Jaggers, professor of surgery at the University of Colorado and chief of cardiothoracic surgery at Children’s Hospital Colorado in Denver, made these comments in an interview. He had no disclosures.
The intermediate-term results reported by Dr. Schubmehl using a Carpentier-Edwards conduit in the right-ventricular outflow tract are clearly better than what we have seen using other types of valves and conduits in this position. If the valve and conduit they used persists with similar performance beyond 10 years, it would be a very good option. However, what typically happens is that replacement valves look good for about 10 years and then start to fail, often with a steep failure curve. I suspect that during the next 10 years of follow-up many more of the valves they placed will start to fail. The 10- to 20-year follow-up period is critical for demonstrating long-term durability of this valve and conduit.
|
Dr. James Jaggers |
One additional potential advantage of the Carpentier-Edwards prosthesis is that the valve it contains is larger than the usual valve placed in the right ventricular outflow tract (RVOT). Failed valves increasingly are replaced by a transcatheter approach that puts a new valve inside the old, failed valve. As patients who received these replacement valves continue to survive we anticipate their need over time for a series of valve-in-valve procedures. The larger the valve at the outset, the more feasible it will be to have multiple episodes of valve-in-valve replacement.
At one time, we regarded early surgical repair of a tetralogy of Fallot defect as curative. We now know that as children with a repaired tetralogy of Fallot grow into teens and adults they require additional repairs, most often replacement of their RVOTs. This has made pulmonary valve replacement the most common surgery for adult survivors of congenital heart disease. The numbers of teen or adult patients who require a new RVOT will steadily increase as more of these children survive.
Dr. James Jaggers, professor of surgery at the University of Colorado and chief of cardiothoracic surgery at Children’s Hospital Colorado in Denver, made these comments in an interview. He had no disclosures.
The intermediate-term results reported by Dr. Schubmehl using a Carpentier-Edwards conduit in the right-ventricular outflow tract are clearly better than what we have seen using other types of valves and conduits in this position. If the valve and conduit they used persists with similar performance beyond 10 years, it would be a very good option. However, what typically happens is that replacement valves look good for about 10 years and then start to fail, often with a steep failure curve. I suspect that during the next 10 years of follow-up many more of the valves they placed will start to fail. The 10- to 20-year follow-up period is critical for demonstrating long-term durability of this valve and conduit.
|
Dr. James Jaggers |
One additional potential advantage of the Carpentier-Edwards prosthesis is that the valve it contains is larger than the usual valve placed in the right ventricular outflow tract (RVOT). Failed valves increasingly are replaced by a transcatheter approach that puts a new valve inside the old, failed valve. As patients who received these replacement valves continue to survive we anticipate their need over time for a series of valve-in-valve procedures. The larger the valve at the outset, the more feasible it will be to have multiple episodes of valve-in-valve replacement.
At one time, we regarded early surgical repair of a tetralogy of Fallot defect as curative. We now know that as children with a repaired tetralogy of Fallot grow into teens and adults they require additional repairs, most often replacement of their RVOTs. This has made pulmonary valve replacement the most common surgery for adult survivors of congenital heart disease. The numbers of teen or adult patients who require a new RVOT will steadily increase as more of these children survive.
Dr. James Jaggers, professor of surgery at the University of Colorado and chief of cardiothoracic surgery at Children’s Hospital Colorado in Denver, made these comments in an interview. He had no disclosures.
PHOENIX – A prosthetic conduit that contains a porcine valve showed excellent intermediate-term durability for repairing the right ventricular outflow tract in 100 teenagers and young adults at a single U.S. center.
“The Carpentier-Edwards xenograft for right ventricular outflow tract [RVOT] reconstruction provides excellent freedom from reoperation and valve dysfunction, as well as sustained improvement in right-ventricular chamber size at intermediate-term follow-up,” Dr. Heidi B. Schubmehl said at the Society of Thoracic Surgeons annual meeting.
Dr. Schubmehl reported a 92% rate of freedom from valve dysfunction with follow-up out to about 10 years, and significant reductions in right ventricular size at follow-up, compared with baseline, as measured by both echocardiography and by MRI.
The Carpentier-Edwards porcine valve and conduit “seemed to hold up better than a lot of other [prosthetic] valves,” said Dr. George M. Alfieris, director of pediatric cardiac surgery at the University of Rochester (N.Y.), and senior author for the study. In addition to the valve’s durability over approximately the first 10 years following placement, the results also showed the positive impact the valve had on right ventricular size, an important result of the repair’s efficacy, Dr. Alfieris said.
“It’s a mistake to allow the right ventricle to be under high pressure or to reach a large volume. We now focus on preserving the right ventricle,” he said in an interview. “I’ve become very concerned about preventing right ventricular dilation and preserving right ventricular function.”
Dr. Alfieris noted that his prior experience using other types of valves in the pulmonary valve and RVOT position showed those valves “did great for the first 10 years and then failed. What’s different in this series is that after 10 years, we have not seen the same dysfunction as with the prior generation of valves. I will be very interested to see what happens to them” as follow-up continues beyond 10 years. He also expressed dismay that recently the company that had been marketing the valve and conduit used in the current study, the Carpentier-Edwards, stopped selling them. He expects that as his supply of conduits runs out he’ll have to start using a different commercial valve and conduit that he believes will not perform as well or create his own conduits with a porcine valve from a different supplier.
The series of 100 patients comprised individuals aged 17 or older who received a pulmonary artery and had RVOT reconstruction at the University of Rochester during 2000-2010, Dr. Schubmehl reported. The series included 78 patients with a history of tetralogy of Fallot, 8 patients born with transposition of their great arteries, 8 patients with truncus arteriosus, and 6 patients with other congenital heart diseases. Their median age at the time they received the RVOT conduit was 24 years, 59% were men, and 99 had undergone a prior sternotomy. At the time they received the conduit, 55 had pulmonary valve insufficiency, 30 had valve stenosis, and 15 had both. Follow-up occurred an average of 7 years after conduit placement.
Two recipients died: One death occurred perioperatively in a 41-year old who had a massive cerebrovascular event, and the second death was in a 39-year old who died 2.6 years after conduit placement from respiratory failure. Two additional patients required a reintervention during follow-up, said Dr. Schubmehl, a general surgeon at the University of Rochester. One reintervention occurred after 11 years to treat endocarditis, and the second after 11 years to perform balloon valvuloplasty because of valve stenosis.
The results reported by Dr. Schubmehl for echocardiography examinations showed that the patients had a statistically significant reduction in their RVOT pressure gradient from baseline to 1-year follow-up that was sustained through their intermediate-term follow-up. Seventy-seven patients had pulmonary valve insufficiency at baseline that resolved in all patients at 1-year follow-up and remained resolved in all but one patient at extended follow-up. Nineteen patients underwent additional imaging with MRI at an average follow-up of 7 years, and these findings confirmed the echo results.
On Twitter @mitchelzoler
PHOENIX – A prosthetic conduit that contains a porcine valve showed excellent intermediate-term durability for repairing the right ventricular outflow tract in 100 teenagers and young adults at a single U.S. center.
“The Carpentier-Edwards xenograft for right ventricular outflow tract [RVOT] reconstruction provides excellent freedom from reoperation and valve dysfunction, as well as sustained improvement in right-ventricular chamber size at intermediate-term follow-up,” Dr. Heidi B. Schubmehl said at the Society of Thoracic Surgeons annual meeting.
Dr. Schubmehl reported a 92% rate of freedom from valve dysfunction with follow-up out to about 10 years, and significant reductions in right ventricular size at follow-up, compared with baseline, as measured by both echocardiography and by MRI.
The Carpentier-Edwards porcine valve and conduit “seemed to hold up better than a lot of other [prosthetic] valves,” said Dr. George M. Alfieris, director of pediatric cardiac surgery at the University of Rochester (N.Y.), and senior author for the study. In addition to the valve’s durability over approximately the first 10 years following placement, the results also showed the positive impact the valve had on right ventricular size, an important result of the repair’s efficacy, Dr. Alfieris said.
“It’s a mistake to allow the right ventricle to be under high pressure or to reach a large volume. We now focus on preserving the right ventricle,” he said in an interview. “I’ve become very concerned about preventing right ventricular dilation and preserving right ventricular function.”
Dr. Alfieris noted that his prior experience using other types of valves in the pulmonary valve and RVOT position showed those valves “did great for the first 10 years and then failed. What’s different in this series is that after 10 years, we have not seen the same dysfunction as with the prior generation of valves. I will be very interested to see what happens to them” as follow-up continues beyond 10 years. He also expressed dismay that recently the company that had been marketing the valve and conduit used in the current study, the Carpentier-Edwards, stopped selling them. He expects that as his supply of conduits runs out he’ll have to start using a different commercial valve and conduit that he believes will not perform as well or create his own conduits with a porcine valve from a different supplier.
The series of 100 patients comprised individuals aged 17 or older who received a pulmonary artery and had RVOT reconstruction at the University of Rochester during 2000-2010, Dr. Schubmehl reported. The series included 78 patients with a history of tetralogy of Fallot, 8 patients born with transposition of their great arteries, 8 patients with truncus arteriosus, and 6 patients with other congenital heart diseases. Their median age at the time they received the RVOT conduit was 24 years, 59% were men, and 99 had undergone a prior sternotomy. At the time they received the conduit, 55 had pulmonary valve insufficiency, 30 had valve stenosis, and 15 had both. Follow-up occurred an average of 7 years after conduit placement.
Two recipients died: One death occurred perioperatively in a 41-year old who had a massive cerebrovascular event, and the second death was in a 39-year old who died 2.6 years after conduit placement from respiratory failure. Two additional patients required a reintervention during follow-up, said Dr. Schubmehl, a general surgeon at the University of Rochester. One reintervention occurred after 11 years to treat endocarditis, and the second after 11 years to perform balloon valvuloplasty because of valve stenosis.
The results reported by Dr. Schubmehl for echocardiography examinations showed that the patients had a statistically significant reduction in their RVOT pressure gradient from baseline to 1-year follow-up that was sustained through their intermediate-term follow-up. Seventy-seven patients had pulmonary valve insufficiency at baseline that resolved in all patients at 1-year follow-up and remained resolved in all but one patient at extended follow-up. Nineteen patients underwent additional imaging with MRI at an average follow-up of 7 years, and these findings confirmed the echo results.
On Twitter @mitchelzoler
AT THE STS ANNUAL MEETING
Key clinical point: A prosthetic conduit with a porcine valve showed excellent durability for congenital heart defect repairs at intermediate-term follow-up.
Major finding: After an average 7-year follow-up, the replacement valve and conduit had a 92% rate of freedom from valve dysfunction.
Data source: Single-center series of 100 patients.
Disclosures: Dr. Schubmehl and Dr. Alfieris had no disclosures.
TAVR forges ahead in PARTNER III for low-risk patients
SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.
The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.
This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.
Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.
This is a study that could upend clinical practice, he observed.
“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.
He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.
Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.
He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.
“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”
To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.
In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.
“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.
“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.
Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.
“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.
Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.
Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.
“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.
The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.
Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.
Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.
“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.
Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.
SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.
The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.
This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.
Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.
This is a study that could upend clinical practice, he observed.
“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.
He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.
Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.
He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.
“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”
To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.
In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.
“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.
“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.
Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.
“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.
Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.
Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.
“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.
The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.
Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.
Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.
“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.
Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.
SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.
The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.
This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.
Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.
This is a study that could upend clinical practice, he observed.
“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.
He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.
Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.
He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.
“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”
To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.
In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.
“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.
“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.
Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.
“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.
Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.
Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.
“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.
The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.
Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.
Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.
“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.
Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Hemodynamic principles key to managing right ventricular heart failure
PHOENIX – In the clinical opinion of Dr. Nevin M. Katz, caring for critical care patients after cardiothoracic surgery requires a multidisciplinary team.
“It used to be just the surgeons and the residents and anesthesiologists, but in this era, it’s a broad team,” Dr. Katz said at the annual meeting of the Society of Thoracic Surgeons. “Coordination of the team, which includes surgeons, anesthesiologists, physician assistants, bedside nurses, nurse practitioners, perfusionists, pharmacists, respiratory therapists, and nutritionists is very important, and it’s important that members of the team be on the same page.”
Dr. Katz, a cardiovascular surgeon/intensivist at Johns Hopkins University, Baltimore, went on to offer tips for managing right ventricular failure in cardiac surgical patients. He recommends that clinicians consider five basic parameters of hemodynamic management: the heart rate and rhythm; the preload; the afterload; contractility; and the surgical result, including the potential for an anatomic problem and the risk of cardiac tamponade. “One must also consider a cardiac assist device,” he said.
He recommended that the cardiac index goal for cardiovascular patients in the ICU be in the range of 2.2-4.4 L per min/m2. The recommended hemodynamic goals also included systemic blood pressure ranges with a systolic pressure of 90-140 mm Hg and a mean arterial pressure of 70-90 mm Hg; a left arterial pressure or pulmonary capillary wedge pressure of 5-18 mm Hg, a right arterial pressure or central venous pressure of 5-15 mm Hg, and a systemic vascular resistance of 800-1,200 dynes per sec/cm5. “When treating right ventricular failure or complex patients, I think advanced PA [pulmonary artery] catheters are valuable, although they’re not absolutely necessary,” he said.
Complementary technologies available in most ICUs can help clinicians manage these patients, particularly ultrasound. With ultrasound, “we can determine where the patient is on the ventricular function curve, regional versus global dysfunction, right ventricular versus left ventricular dysfunction, valve dysfunction, and cardiac tamponade,” said Dr. Katz, who also created the Foundation for the Advancement of Cardiothoracic Care, also known as FACTS-Care. “It’s a very important monitoring modality.”
An important goal in managing patients with right ventricular failure is to establish an optimal heart rate and rhythm. “We have modalities to treat bradycardia and heart block,” he said. “Loss of atrial contraction is very important. If we can avoid atrial fibrillation, that’s good. Ventricular arrhythmias can be a problem, and nowadays we can treat atrioventricular and ventricular dyssynchrony.”
Optimal preload requires a focus on volume responsiveness, Dr. Katz continued. “Where is the patient on that ventricular function curve?” he asked. “With the advanced PA catheters, there are ways to look at that. You would like to be on the ascending part of that curve.” Clinicians can also use pulsus paradoxus, a variation of systemic arterial pulse volume. “That will indicate that perhaps you’re low in volume, but you can use stroke volume variation with an advanced PA catheter,” he said. “If your stroke volume variation is greater than 15% you’re on the ascending part of the curve. But if your stroke volume variation is less than 15%, your volume is probably optimal and you’re not going to be volume responsive.”
Clinicians who lack the benefit of an advanced PA catheter can assess volume responsiveness with passive leg raising.
Low preload causes of RV failure include hypovolemia, bleeding, third-spacing, high urine output, and cardiac tamponade. High preload can be a problem, too, from excess fluid administration, tricuspid or pulmonary valve regurgitation, or from left to right shunting.
Overall, optimal management of RV failure depends on the coordination of the multidisciplinary critical care team.
Dr. Katz reported having no financial disclosures.
PHOENIX – In the clinical opinion of Dr. Nevin M. Katz, caring for critical care patients after cardiothoracic surgery requires a multidisciplinary team.
“It used to be just the surgeons and the residents and anesthesiologists, but in this era, it’s a broad team,” Dr. Katz said at the annual meeting of the Society of Thoracic Surgeons. “Coordination of the team, which includes surgeons, anesthesiologists, physician assistants, bedside nurses, nurse practitioners, perfusionists, pharmacists, respiratory therapists, and nutritionists is very important, and it’s important that members of the team be on the same page.”
Dr. Katz, a cardiovascular surgeon/intensivist at Johns Hopkins University, Baltimore, went on to offer tips for managing right ventricular failure in cardiac surgical patients. He recommends that clinicians consider five basic parameters of hemodynamic management: the heart rate and rhythm; the preload; the afterload; contractility; and the surgical result, including the potential for an anatomic problem and the risk of cardiac tamponade. “One must also consider a cardiac assist device,” he said.
He recommended that the cardiac index goal for cardiovascular patients in the ICU be in the range of 2.2-4.4 L per min/m2. The recommended hemodynamic goals also included systemic blood pressure ranges with a systolic pressure of 90-140 mm Hg and a mean arterial pressure of 70-90 mm Hg; a left arterial pressure or pulmonary capillary wedge pressure of 5-18 mm Hg, a right arterial pressure or central venous pressure of 5-15 mm Hg, and a systemic vascular resistance of 800-1,200 dynes per sec/cm5. “When treating right ventricular failure or complex patients, I think advanced PA [pulmonary artery] catheters are valuable, although they’re not absolutely necessary,” he said.
Complementary technologies available in most ICUs can help clinicians manage these patients, particularly ultrasound. With ultrasound, “we can determine where the patient is on the ventricular function curve, regional versus global dysfunction, right ventricular versus left ventricular dysfunction, valve dysfunction, and cardiac tamponade,” said Dr. Katz, who also created the Foundation for the Advancement of Cardiothoracic Care, also known as FACTS-Care. “It’s a very important monitoring modality.”
An important goal in managing patients with right ventricular failure is to establish an optimal heart rate and rhythm. “We have modalities to treat bradycardia and heart block,” he said. “Loss of atrial contraction is very important. If we can avoid atrial fibrillation, that’s good. Ventricular arrhythmias can be a problem, and nowadays we can treat atrioventricular and ventricular dyssynchrony.”
Optimal preload requires a focus on volume responsiveness, Dr. Katz continued. “Where is the patient on that ventricular function curve?” he asked. “With the advanced PA catheters, there are ways to look at that. You would like to be on the ascending part of that curve.” Clinicians can also use pulsus paradoxus, a variation of systemic arterial pulse volume. “That will indicate that perhaps you’re low in volume, but you can use stroke volume variation with an advanced PA catheter,” he said. “If your stroke volume variation is greater than 15% you’re on the ascending part of the curve. But if your stroke volume variation is less than 15%, your volume is probably optimal and you’re not going to be volume responsive.”
Clinicians who lack the benefit of an advanced PA catheter can assess volume responsiveness with passive leg raising.
Low preload causes of RV failure include hypovolemia, bleeding, third-spacing, high urine output, and cardiac tamponade. High preload can be a problem, too, from excess fluid administration, tricuspid or pulmonary valve regurgitation, or from left to right shunting.
Overall, optimal management of RV failure depends on the coordination of the multidisciplinary critical care team.
Dr. Katz reported having no financial disclosures.
PHOENIX – In the clinical opinion of Dr. Nevin M. Katz, caring for critical care patients after cardiothoracic surgery requires a multidisciplinary team.
“It used to be just the surgeons and the residents and anesthesiologists, but in this era, it’s a broad team,” Dr. Katz said at the annual meeting of the Society of Thoracic Surgeons. “Coordination of the team, which includes surgeons, anesthesiologists, physician assistants, bedside nurses, nurse practitioners, perfusionists, pharmacists, respiratory therapists, and nutritionists is very important, and it’s important that members of the team be on the same page.”
Dr. Katz, a cardiovascular surgeon/intensivist at Johns Hopkins University, Baltimore, went on to offer tips for managing right ventricular failure in cardiac surgical patients. He recommends that clinicians consider five basic parameters of hemodynamic management: the heart rate and rhythm; the preload; the afterload; contractility; and the surgical result, including the potential for an anatomic problem and the risk of cardiac tamponade. “One must also consider a cardiac assist device,” he said.
He recommended that the cardiac index goal for cardiovascular patients in the ICU be in the range of 2.2-4.4 L per min/m2. The recommended hemodynamic goals also included systemic blood pressure ranges with a systolic pressure of 90-140 mm Hg and a mean arterial pressure of 70-90 mm Hg; a left arterial pressure or pulmonary capillary wedge pressure of 5-18 mm Hg, a right arterial pressure or central venous pressure of 5-15 mm Hg, and a systemic vascular resistance of 800-1,200 dynes per sec/cm5. “When treating right ventricular failure or complex patients, I think advanced PA [pulmonary artery] catheters are valuable, although they’re not absolutely necessary,” he said.
Complementary technologies available in most ICUs can help clinicians manage these patients, particularly ultrasound. With ultrasound, “we can determine where the patient is on the ventricular function curve, regional versus global dysfunction, right ventricular versus left ventricular dysfunction, valve dysfunction, and cardiac tamponade,” said Dr. Katz, who also created the Foundation for the Advancement of Cardiothoracic Care, also known as FACTS-Care. “It’s a very important monitoring modality.”
An important goal in managing patients with right ventricular failure is to establish an optimal heart rate and rhythm. “We have modalities to treat bradycardia and heart block,” he said. “Loss of atrial contraction is very important. If we can avoid atrial fibrillation, that’s good. Ventricular arrhythmias can be a problem, and nowadays we can treat atrioventricular and ventricular dyssynchrony.”
Optimal preload requires a focus on volume responsiveness, Dr. Katz continued. “Where is the patient on that ventricular function curve?” he asked. “With the advanced PA catheters, there are ways to look at that. You would like to be on the ascending part of that curve.” Clinicians can also use pulsus paradoxus, a variation of systemic arterial pulse volume. “That will indicate that perhaps you’re low in volume, but you can use stroke volume variation with an advanced PA catheter,” he said. “If your stroke volume variation is greater than 15% you’re on the ascending part of the curve. But if your stroke volume variation is less than 15%, your volume is probably optimal and you’re not going to be volume responsive.”
Clinicians who lack the benefit of an advanced PA catheter can assess volume responsiveness with passive leg raising.
Low preload causes of RV failure include hypovolemia, bleeding, third-spacing, high urine output, and cardiac tamponade. High preload can be a problem, too, from excess fluid administration, tricuspid or pulmonary valve regurgitation, or from left to right shunting.
Overall, optimal management of RV failure depends on the coordination of the multidisciplinary critical care team.
Dr. Katz reported having no financial disclosures.
EXPERT ANALYSIS AT THE STS ANNUAL MEETING
Study evaluates which prior cancers pose a risk for developing NSCLC
PHOENIX – Patients with a history of head and neck, lung, bladder, and hematologic malignancies had increased rates of subsequent non–small cell lung cancer (NSCLC), a large analysis of national data found.
“It is unclear to what extent the higher rate of primary NSCLC in these patients may be attributed to smoking, previous cancer history, or other lung cancer risk factors,” researchers led by Dr. Geena Wu wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons. “Further research using individual smoking data may better delineate who is at increased risk of NSCLC based on prior cancer site and smoking history.”
In a study that Dr. Wu led during a research fellowship at the City of Hope National Medical Center, Duarte, Calif., she and her associates used the Surveillance, Epidemiology, and End Results (SEER) 1992-2007 dataset to identify 32,058 patients with a prior malignancy who subsequently developed primary lung cancer at 6 months or more after their initial cancer. They calculated standardized incidence ratios (SIRs) for NSCLC as a rate of observed to expected NSCLC cases adjusted by person-years at risk, age, gender, and time of diagnosis.
The researchers found that patients with a history of the following cancers had higher rates of second primary NSCLC than expected: head and neck (SIR, 4.00), colon and rectum (SIR, 1.16), pancreas (SIR, 1.44), lung (SIR, 4.88), bladder (SIR, 1.97), kidney (SIR, 1.21), breast (SIR, 1.09), and leukemia or lymphoma (SIR, 1.40).
At the same time, patients with a history of pancreatic or breast cancer who were treated with radiation had a higher incidence of second primary NSCLC (SIR of 2.54 and SIR of 1.14, respectively), while those who were not treated with radiation did not.
Although the SEER database does not contain information about patient smoking history, the researchers evaluated adult smoking rates by state by using a national map from the Centers for Disease Control and Prevention’s 2013 Behavioral Risk Factor Surveillance System. Smoking rates were low (defined as 13.7% or less) in California, Hawaii, and Utah, and were higher in all other states, especially in Southeastern states. Dr. Wu and her associates found that patients from high smoking areas who had previous cancers of the colon and rectum, pancreas, kidney, thyroid, and breast had higher rates of a primary NSCLC, while those from low smoking areas did not. Interestingly, patients from high smoking areas who previously had uterine cancer, prostate, or melanoma had did not have higher rates of a primary NSCLC.
“Just because someone has a previous history of cancer, they’re not necessarily at increased risk of a second lung cancer,” Dr. Wu, who is now a fourth-year general surgery resident at Maricopa County Hospital in Phoenix said in an interview at the meeting. “You have to look at what kind of cancer they had and what their smoking history is – whether or not they continue to smoke, because smoking is such an important risk factor.”
Another limitation of the SEER database is that it lacks details about the type of chemotherapy patients receive, “so whether or not chemotherapy plays an impact in the elevated risk of lung cancer we can’t say.”
Dr. Wu reported having no financial disclosures.
PHOENIX – Patients with a history of head and neck, lung, bladder, and hematologic malignancies had increased rates of subsequent non–small cell lung cancer (NSCLC), a large analysis of national data found.
“It is unclear to what extent the higher rate of primary NSCLC in these patients may be attributed to smoking, previous cancer history, or other lung cancer risk factors,” researchers led by Dr. Geena Wu wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons. “Further research using individual smoking data may better delineate who is at increased risk of NSCLC based on prior cancer site and smoking history.”
In a study that Dr. Wu led during a research fellowship at the City of Hope National Medical Center, Duarte, Calif., she and her associates used the Surveillance, Epidemiology, and End Results (SEER) 1992-2007 dataset to identify 32,058 patients with a prior malignancy who subsequently developed primary lung cancer at 6 months or more after their initial cancer. They calculated standardized incidence ratios (SIRs) for NSCLC as a rate of observed to expected NSCLC cases adjusted by person-years at risk, age, gender, and time of diagnosis.
The researchers found that patients with a history of the following cancers had higher rates of second primary NSCLC than expected: head and neck (SIR, 4.00), colon and rectum (SIR, 1.16), pancreas (SIR, 1.44), lung (SIR, 4.88), bladder (SIR, 1.97), kidney (SIR, 1.21), breast (SIR, 1.09), and leukemia or lymphoma (SIR, 1.40).
At the same time, patients with a history of pancreatic or breast cancer who were treated with radiation had a higher incidence of second primary NSCLC (SIR of 2.54 and SIR of 1.14, respectively), while those who were not treated with radiation did not.
Although the SEER database does not contain information about patient smoking history, the researchers evaluated adult smoking rates by state by using a national map from the Centers for Disease Control and Prevention’s 2013 Behavioral Risk Factor Surveillance System. Smoking rates were low (defined as 13.7% or less) in California, Hawaii, and Utah, and were higher in all other states, especially in Southeastern states. Dr. Wu and her associates found that patients from high smoking areas who had previous cancers of the colon and rectum, pancreas, kidney, thyroid, and breast had higher rates of a primary NSCLC, while those from low smoking areas did not. Interestingly, patients from high smoking areas who previously had uterine cancer, prostate, or melanoma had did not have higher rates of a primary NSCLC.
“Just because someone has a previous history of cancer, they’re not necessarily at increased risk of a second lung cancer,” Dr. Wu, who is now a fourth-year general surgery resident at Maricopa County Hospital in Phoenix said in an interview at the meeting. “You have to look at what kind of cancer they had and what their smoking history is – whether or not they continue to smoke, because smoking is such an important risk factor.”
Another limitation of the SEER database is that it lacks details about the type of chemotherapy patients receive, “so whether or not chemotherapy plays an impact in the elevated risk of lung cancer we can’t say.”
Dr. Wu reported having no financial disclosures.
PHOENIX – Patients with a history of head and neck, lung, bladder, and hematologic malignancies had increased rates of subsequent non–small cell lung cancer (NSCLC), a large analysis of national data found.
“It is unclear to what extent the higher rate of primary NSCLC in these patients may be attributed to smoking, previous cancer history, or other lung cancer risk factors,” researchers led by Dr. Geena Wu wrote in an abstract presented during a poster session at the annual meeting of the Society of Thoracic Surgeons. “Further research using individual smoking data may better delineate who is at increased risk of NSCLC based on prior cancer site and smoking history.”
In a study that Dr. Wu led during a research fellowship at the City of Hope National Medical Center, Duarte, Calif., she and her associates used the Surveillance, Epidemiology, and End Results (SEER) 1992-2007 dataset to identify 32,058 patients with a prior malignancy who subsequently developed primary lung cancer at 6 months or more after their initial cancer. They calculated standardized incidence ratios (SIRs) for NSCLC as a rate of observed to expected NSCLC cases adjusted by person-years at risk, age, gender, and time of diagnosis.
The researchers found that patients with a history of the following cancers had higher rates of second primary NSCLC than expected: head and neck (SIR, 4.00), colon and rectum (SIR, 1.16), pancreas (SIR, 1.44), lung (SIR, 4.88), bladder (SIR, 1.97), kidney (SIR, 1.21), breast (SIR, 1.09), and leukemia or lymphoma (SIR, 1.40).
At the same time, patients with a history of pancreatic or breast cancer who were treated with radiation had a higher incidence of second primary NSCLC (SIR of 2.54 and SIR of 1.14, respectively), while those who were not treated with radiation did not.
Although the SEER database does not contain information about patient smoking history, the researchers evaluated adult smoking rates by state by using a national map from the Centers for Disease Control and Prevention’s 2013 Behavioral Risk Factor Surveillance System. Smoking rates were low (defined as 13.7% or less) in California, Hawaii, and Utah, and were higher in all other states, especially in Southeastern states. Dr. Wu and her associates found that patients from high smoking areas who had previous cancers of the colon and rectum, pancreas, kidney, thyroid, and breast had higher rates of a primary NSCLC, while those from low smoking areas did not. Interestingly, patients from high smoking areas who previously had uterine cancer, prostate, or melanoma had did not have higher rates of a primary NSCLC.
“Just because someone has a previous history of cancer, they’re not necessarily at increased risk of a second lung cancer,” Dr. Wu, who is now a fourth-year general surgery resident at Maricopa County Hospital in Phoenix said in an interview at the meeting. “You have to look at what kind of cancer they had and what their smoking history is – whether or not they continue to smoke, because smoking is such an important risk factor.”
Another limitation of the SEER database is that it lacks details about the type of chemotherapy patients receive, “so whether or not chemotherapy plays an impact in the elevated risk of lung cancer we can’t say.”
Dr. Wu reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point: Not all patients with history of cancer face an increased risk of developing subsequent NSCLC.
Major finding: Patients with a history of the following cancers had higher rates of second primary NSCLC than expected: head and neck (SIR, 4.00), colon and rectum (SIR, 1.16), pancreas (SIR, 1.44), lung (SIR, 4.88), bladder (SIR, 1.97), kidney (SIR, 1.21), breast (SIR, 1.09), and leukemia or lymphoma (SIR, 1.40).
Data source: An analysis of 32,058 patients with a prior malignancy that subsequently developed primary lung cancer at 6 months or more after their initial cancer.
Disclosures: Dr. Wu reported having no financial disclosures.