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VIDEO: Cardiothoracic surgeon shortage requires action
BALTIMORE – By 2035, U.S. cardiothoracic surgeons will see a 61% increase in the national caseload, and potentially a 121% increase in cases for each surgeon, according to a data analysis presented at the annual meeting of the American Association for Thoracic Surgery.
Using data from the American Board of Thoracic Surgery, a research team at Ohio State University performed case load calculations for 2035 based on cases per surgeon per year in 2010. The researchers estimated that the average caseload per surgeon in 2035 will be 299 cases, compared with a 2010 caseload of 135 per surgeon. This increase is not matched by the number of surgeons currently trained and certified annually.
Dr. John Ikonomidis, chief of the division of cardiothoracic surgery at the Medical University of South Carolina in Charleston, and a discussant on the presentation, said surgeon retirements and an increase in the population needing treatment have put the specialty in a bind.
“We have a bit of a crisis now, honestly, but this particular paper puts it in even further perspective,” Dr. Ikonomidis said in a video interview. “By 2035 we’re looking at a 3,000-surgeon shortage, relative to what would be available.” He noted that approximately 90 medical residents per year are certified as cardiothoracic surgeons, a rate which will not produce enough CT surgeons to meet the projected shortage.
“We need to continue to have this conversation,” he concluded. “It is a reminder that the predictions we made 15 years ago appear to be true, and we probably need to do something about it, at least in the short term.”
Dr. Ikonomidis reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
BALTIMORE – By 2035, U.S. cardiothoracic surgeons will see a 61% increase in the national caseload, and potentially a 121% increase in cases for each surgeon, according to a data analysis presented at the annual meeting of the American Association for Thoracic Surgery.
Using data from the American Board of Thoracic Surgery, a research team at Ohio State University performed case load calculations for 2035 based on cases per surgeon per year in 2010. The researchers estimated that the average caseload per surgeon in 2035 will be 299 cases, compared with a 2010 caseload of 135 per surgeon. This increase is not matched by the number of surgeons currently trained and certified annually.
Dr. John Ikonomidis, chief of the division of cardiothoracic surgery at the Medical University of South Carolina in Charleston, and a discussant on the presentation, said surgeon retirements and an increase in the population needing treatment have put the specialty in a bind.
“We have a bit of a crisis now, honestly, but this particular paper puts it in even further perspective,” Dr. Ikonomidis said in a video interview. “By 2035 we’re looking at a 3,000-surgeon shortage, relative to what would be available.” He noted that approximately 90 medical residents per year are certified as cardiothoracic surgeons, a rate which will not produce enough CT surgeons to meet the projected shortage.
“We need to continue to have this conversation,” he concluded. “It is a reminder that the predictions we made 15 years ago appear to be true, and we probably need to do something about it, at least in the short term.”
Dr. Ikonomidis reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
BALTIMORE – By 2035, U.S. cardiothoracic surgeons will see a 61% increase in the national caseload, and potentially a 121% increase in cases for each surgeon, according to a data analysis presented at the annual meeting of the American Association for Thoracic Surgery.
Using data from the American Board of Thoracic Surgery, a research team at Ohio State University performed case load calculations for 2035 based on cases per surgeon per year in 2010. The researchers estimated that the average caseload per surgeon in 2035 will be 299 cases, compared with a 2010 caseload of 135 per surgeon. This increase is not matched by the number of surgeons currently trained and certified annually.
Dr. John Ikonomidis, chief of the division of cardiothoracic surgery at the Medical University of South Carolina in Charleston, and a discussant on the presentation, said surgeon retirements and an increase in the population needing treatment have put the specialty in a bind.
“We have a bit of a crisis now, honestly, but this particular paper puts it in even further perspective,” Dr. Ikonomidis said in a video interview. “By 2035 we’re looking at a 3,000-surgeon shortage, relative to what would be available.” He noted that approximately 90 medical residents per year are certified as cardiothoracic surgeons, a rate which will not produce enough CT surgeons to meet the projected shortage.
“We need to continue to have this conversation,” he concluded. “It is a reminder that the predictions we made 15 years ago appear to be true, and we probably need to do something about it, at least in the short term.”
Dr. Ikonomidis reported no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @richpizzi
AT THE AATS ANNUAL MEETING
Ripple effect of complications in lung transplant
As the frequency of lung transplants rises, so too has the strain on resources to manage in-hospital complications after those operations. Researchers from the University of Pittsburgh have identified independent predictors of short-term complications that can compromise long-term survival in these patients in what they said is the first study to systematically evaluate and profile such complications.
“These results may identify important targets for best practice guidelines and quality-of-care measures after lung transplantation,” reported Dr. Ernest G. Chan and colleagues (J Thorac Cardiovasc Surg 2016 April;151:1171-80).
The study involved 748 patients in the University of Pittsburgh Medical Center Transplant Patient Management System database who had in-hospital complications after single- or double-lung transplant from January 2007 to October 2013. The researchers analyzed 3,381 such complications in 92.78% of these patients, grading the complications via the extended Accordion Severity Grading System (ASGS). The median follow-up of the cohort was 5.4 years.
The researchers also classified complications that carried significant decrease in 5-year survival into three categories: renal complications, with a hazard ratio (HR) of 2.58; hepatic, with an HR of 4.08; and cardiac, with an HR of 1.95.
“Multivariate analysis identified a weighted ASGS sum of greater than 10 and renal, cardiac, and vascular complications as predictors of decreased long-term survival,” Dr. Chan and colleagues noted.
In-hospital complications are important predictors of long-term survival, Dr. Chan and coauthors wrote, citing studies from Memorial Sloan-Kettering Cancer Center in New York and the University of Minnesota. (N Engl J Med. 2001;345:181-8;Ann Surg. 2011;254:368-74). They also noted variable findings of several studies with regard to the impact center volume can have on long-term survival, particularly because high-volume centers may be better prepared to manage those complications.
“These important finding highlight the need for further in-depth analysis into an intriguing aspect of surgical management of complications after high-risk procedures,” the researchers wrote. Their goal was to create a postoperative complication profile for lung transplant patients.
Of the 748 patients in the study, 7.22% (54) had an uneventful postoperative course. The noncomplication group had a cumulative 5-year survival of around 73.8% vs. 53.3% for the complications group. On average, each patient in the complication group had almost five different complications. The most common were pulmonary in nature (71.66%), followed by infections (69.52%), pleural space–related problems (46.12%), renal complications (36.23%), and cardiac (35.83%). Renal complications accounted for the greatest decrease in 5-year survival at 35.4% vs. 64.4% in patients who did not have renal complications.
Survival rates for other categories of complications vs. the absence of those complications were: hepatic, 18.1% vs. 57.3%; cardiac, 39.5% vs. 62.3%; vascular, 29.4% vs. 58.5%; neurologic, 32.6% vs. 57.1%; musculoskeletal, 27.4% vs. 56.8%; and pleural-space complications, 48.7% vs. 60.3%.
The multivariate analysis assigned hazard ratios to these predictors: age older than 65 years, 1.01; renal events, 1.70; cardiac events, 1.29; vascular events, 1.33; and weighted ASGS sum, 1.08. Besides ASGS severity, the researchers considered Charlson Comorbidity Index analysis, but found that it had no significant effect on hazard ratio, the researchers said.
“With appropriate patients selection and contemporary surgical techniques, vigilant postoperative management and avoidance of adverse events may potentially offer patients better long-term outcomes,” Dr. Chan and colleagues noted. “The overall 90-day postoperative course has an influence on long-term survival.”
Among those factors that influence survival are the severity of the intervention to treat the complication and the occurrence of less-severe complications, they added. “The next step is to identify interventions that effectively reduce the incidence, as well as severity, of in-hospital, postoperative complications.”
The researchers had no financial relationships to disclose.
The study findings show not only that complications after lung transplantation “are nearly ubiquitous” but also that clinicians need better management strategies to address them, Katie Kinaschuk and Dr. Jayan Nagendran said in their invited commentary (J Thorac Cardiovasc Surg. 2016;151:1181-2).
The multivariate analysis by Dr. Chan and colleagues shows a strong correlation between nonpulmonary complications and decreased long-term survival in patients who have had lung transplants, but this does not downplay the significance of pulmonary and infectious complications, Ms. Kinaschuk and Dr. Nagendran noted. “Thus, despite the need to improve treatment algorithms of highly predictive non–allograft-related complications, the greatest opportunity to decrease the overall rates of complications still exists within pulmonary and infectious etiologies.”
Noteworthy among the study findings was that the Charlson Comorbidity Index values were not a predictor for long-term survival, they wrote. That may suggest that factors of the operation itself, along with donor tissue, may have important roles in the link between postoperative complications and decreased long-term survival. “This may represent the need for careful reporting and consideration of non–allograft-related postoperative complications in assessing new technologies for donor lung management,” they said.
The “ripple effect” of early postoperative complications “may warrant more vigilant long-term surveillance once a complication has occurred,” the commentators noted. “Ultimately, determination of preventive measures by identifying predictors of complications will have the greatest positive effect on survival,” an area that needs further investigation, they wrote.
Ms. Kinaschuk and Dr. Nagendran had no relationships to disclose.
The study findings show not only that complications after lung transplantation “are nearly ubiquitous” but also that clinicians need better management strategies to address them, Katie Kinaschuk and Dr. Jayan Nagendran said in their invited commentary (J Thorac Cardiovasc Surg. 2016;151:1181-2).
The multivariate analysis by Dr. Chan and colleagues shows a strong correlation between nonpulmonary complications and decreased long-term survival in patients who have had lung transplants, but this does not downplay the significance of pulmonary and infectious complications, Ms. Kinaschuk and Dr. Nagendran noted. “Thus, despite the need to improve treatment algorithms of highly predictive non–allograft-related complications, the greatest opportunity to decrease the overall rates of complications still exists within pulmonary and infectious etiologies.”
Noteworthy among the study findings was that the Charlson Comorbidity Index values were not a predictor for long-term survival, they wrote. That may suggest that factors of the operation itself, along with donor tissue, may have important roles in the link between postoperative complications and decreased long-term survival. “This may represent the need for careful reporting and consideration of non–allograft-related postoperative complications in assessing new technologies for donor lung management,” they said.
The “ripple effect” of early postoperative complications “may warrant more vigilant long-term surveillance once a complication has occurred,” the commentators noted. “Ultimately, determination of preventive measures by identifying predictors of complications will have the greatest positive effect on survival,” an area that needs further investigation, they wrote.
Ms. Kinaschuk and Dr. Nagendran had no relationships to disclose.
The study findings show not only that complications after lung transplantation “are nearly ubiquitous” but also that clinicians need better management strategies to address them, Katie Kinaschuk and Dr. Jayan Nagendran said in their invited commentary (J Thorac Cardiovasc Surg. 2016;151:1181-2).
The multivariate analysis by Dr. Chan and colleagues shows a strong correlation between nonpulmonary complications and decreased long-term survival in patients who have had lung transplants, but this does not downplay the significance of pulmonary and infectious complications, Ms. Kinaschuk and Dr. Nagendran noted. “Thus, despite the need to improve treatment algorithms of highly predictive non–allograft-related complications, the greatest opportunity to decrease the overall rates of complications still exists within pulmonary and infectious etiologies.”
Noteworthy among the study findings was that the Charlson Comorbidity Index values were not a predictor for long-term survival, they wrote. That may suggest that factors of the operation itself, along with donor tissue, may have important roles in the link between postoperative complications and decreased long-term survival. “This may represent the need for careful reporting and consideration of non–allograft-related postoperative complications in assessing new technologies for donor lung management,” they said.
The “ripple effect” of early postoperative complications “may warrant more vigilant long-term surveillance once a complication has occurred,” the commentators noted. “Ultimately, determination of preventive measures by identifying predictors of complications will have the greatest positive effect on survival,” an area that needs further investigation, they wrote.
Ms. Kinaschuk and Dr. Nagendran had no relationships to disclose.
As the frequency of lung transplants rises, so too has the strain on resources to manage in-hospital complications after those operations. Researchers from the University of Pittsburgh have identified independent predictors of short-term complications that can compromise long-term survival in these patients in what they said is the first study to systematically evaluate and profile such complications.
“These results may identify important targets for best practice guidelines and quality-of-care measures after lung transplantation,” reported Dr. Ernest G. Chan and colleagues (J Thorac Cardiovasc Surg 2016 April;151:1171-80).
The study involved 748 patients in the University of Pittsburgh Medical Center Transplant Patient Management System database who had in-hospital complications after single- or double-lung transplant from January 2007 to October 2013. The researchers analyzed 3,381 such complications in 92.78% of these patients, grading the complications via the extended Accordion Severity Grading System (ASGS). The median follow-up of the cohort was 5.4 years.
The researchers also classified complications that carried significant decrease in 5-year survival into three categories: renal complications, with a hazard ratio (HR) of 2.58; hepatic, with an HR of 4.08; and cardiac, with an HR of 1.95.
“Multivariate analysis identified a weighted ASGS sum of greater than 10 and renal, cardiac, and vascular complications as predictors of decreased long-term survival,” Dr. Chan and colleagues noted.
In-hospital complications are important predictors of long-term survival, Dr. Chan and coauthors wrote, citing studies from Memorial Sloan-Kettering Cancer Center in New York and the University of Minnesota. (N Engl J Med. 2001;345:181-8;Ann Surg. 2011;254:368-74). They also noted variable findings of several studies with regard to the impact center volume can have on long-term survival, particularly because high-volume centers may be better prepared to manage those complications.
“These important finding highlight the need for further in-depth analysis into an intriguing aspect of surgical management of complications after high-risk procedures,” the researchers wrote. Their goal was to create a postoperative complication profile for lung transplant patients.
Of the 748 patients in the study, 7.22% (54) had an uneventful postoperative course. The noncomplication group had a cumulative 5-year survival of around 73.8% vs. 53.3% for the complications group. On average, each patient in the complication group had almost five different complications. The most common were pulmonary in nature (71.66%), followed by infections (69.52%), pleural space–related problems (46.12%), renal complications (36.23%), and cardiac (35.83%). Renal complications accounted for the greatest decrease in 5-year survival at 35.4% vs. 64.4% in patients who did not have renal complications.
Survival rates for other categories of complications vs. the absence of those complications were: hepatic, 18.1% vs. 57.3%; cardiac, 39.5% vs. 62.3%; vascular, 29.4% vs. 58.5%; neurologic, 32.6% vs. 57.1%; musculoskeletal, 27.4% vs. 56.8%; and pleural-space complications, 48.7% vs. 60.3%.
The multivariate analysis assigned hazard ratios to these predictors: age older than 65 years, 1.01; renal events, 1.70; cardiac events, 1.29; vascular events, 1.33; and weighted ASGS sum, 1.08. Besides ASGS severity, the researchers considered Charlson Comorbidity Index analysis, but found that it had no significant effect on hazard ratio, the researchers said.
“With appropriate patients selection and contemporary surgical techniques, vigilant postoperative management and avoidance of adverse events may potentially offer patients better long-term outcomes,” Dr. Chan and colleagues noted. “The overall 90-day postoperative course has an influence on long-term survival.”
Among those factors that influence survival are the severity of the intervention to treat the complication and the occurrence of less-severe complications, they added. “The next step is to identify interventions that effectively reduce the incidence, as well as severity, of in-hospital, postoperative complications.”
The researchers had no financial relationships to disclose.
As the frequency of lung transplants rises, so too has the strain on resources to manage in-hospital complications after those operations. Researchers from the University of Pittsburgh have identified independent predictors of short-term complications that can compromise long-term survival in these patients in what they said is the first study to systematically evaluate and profile such complications.
“These results may identify important targets for best practice guidelines and quality-of-care measures after lung transplantation,” reported Dr. Ernest G. Chan and colleagues (J Thorac Cardiovasc Surg 2016 April;151:1171-80).
The study involved 748 patients in the University of Pittsburgh Medical Center Transplant Patient Management System database who had in-hospital complications after single- or double-lung transplant from January 2007 to October 2013. The researchers analyzed 3,381 such complications in 92.78% of these patients, grading the complications via the extended Accordion Severity Grading System (ASGS). The median follow-up of the cohort was 5.4 years.
The researchers also classified complications that carried significant decrease in 5-year survival into three categories: renal complications, with a hazard ratio (HR) of 2.58; hepatic, with an HR of 4.08; and cardiac, with an HR of 1.95.
“Multivariate analysis identified a weighted ASGS sum of greater than 10 and renal, cardiac, and vascular complications as predictors of decreased long-term survival,” Dr. Chan and colleagues noted.
In-hospital complications are important predictors of long-term survival, Dr. Chan and coauthors wrote, citing studies from Memorial Sloan-Kettering Cancer Center in New York and the University of Minnesota. (N Engl J Med. 2001;345:181-8;Ann Surg. 2011;254:368-74). They also noted variable findings of several studies with regard to the impact center volume can have on long-term survival, particularly because high-volume centers may be better prepared to manage those complications.
“These important finding highlight the need for further in-depth analysis into an intriguing aspect of surgical management of complications after high-risk procedures,” the researchers wrote. Their goal was to create a postoperative complication profile for lung transplant patients.
Of the 748 patients in the study, 7.22% (54) had an uneventful postoperative course. The noncomplication group had a cumulative 5-year survival of around 73.8% vs. 53.3% for the complications group. On average, each patient in the complication group had almost five different complications. The most common were pulmonary in nature (71.66%), followed by infections (69.52%), pleural space–related problems (46.12%), renal complications (36.23%), and cardiac (35.83%). Renal complications accounted for the greatest decrease in 5-year survival at 35.4% vs. 64.4% in patients who did not have renal complications.
Survival rates for other categories of complications vs. the absence of those complications were: hepatic, 18.1% vs. 57.3%; cardiac, 39.5% vs. 62.3%; vascular, 29.4% vs. 58.5%; neurologic, 32.6% vs. 57.1%; musculoskeletal, 27.4% vs. 56.8%; and pleural-space complications, 48.7% vs. 60.3%.
The multivariate analysis assigned hazard ratios to these predictors: age older than 65 years, 1.01; renal events, 1.70; cardiac events, 1.29; vascular events, 1.33; and weighted ASGS sum, 1.08. Besides ASGS severity, the researchers considered Charlson Comorbidity Index analysis, but found that it had no significant effect on hazard ratio, the researchers said.
“With appropriate patients selection and contemporary surgical techniques, vigilant postoperative management and avoidance of adverse events may potentially offer patients better long-term outcomes,” Dr. Chan and colleagues noted. “The overall 90-day postoperative course has an influence on long-term survival.”
Among those factors that influence survival are the severity of the intervention to treat the complication and the occurrence of less-severe complications, they added. “The next step is to identify interventions that effectively reduce the incidence, as well as severity, of in-hospital, postoperative complications.”
The researchers had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Early complications after lung transplant surgery can negatively impact survival and long-term outcomes.
Major finding: Postoperative complications occurred in 92.78% of patients. Median follow-up was 5.4 years.
Data source: Retrospective analysis of 748 patients in the University of Pittsburgh Medical Center Transplant Patient Management System who had lung transplants from January 2007 to October 2013.
Disclosures: The study investigators had no relationships to disclose.
Hybrid option ‘reasonable’ for HLHS?
Although the classic Norwood palliation for infants with hypoplastic left heart syndrome (HLHS) has been well established, the procedure has had its drawbacks, namely the need for cardiopulmonary bypass with hypothermia and a because it rules out biventricular correction months later. A hybrid procedure avoids the need for bypass and accommodates short-term biventricular correction, but it has lacked strong evidence.
Researchers from Justus-Liebig University Giessen, Germany, reported on 182 patients with HLHS who had the three-stage Giessen hybrid procedure, noting 10-year survival of almost 80% with almost a third of patients requiring no artery intervention in that time (J Thorac Cardiovasc Surg. 2016 April;151:1112-23).
“In view of the early results and long-term outcome after Giessen hybrid palliation, the hybrid approach has become a reasonable alternative to the conventional strategy to treat neonates with HLHS and variants,” wrote Dr. Can Yerebakan and colleagues. “Further refinements are warranted to decrease patient morbidity.”
The Giessen hybrid procedure uses a technique to control pulmonary blood flow that is different from the Norwood procedure. The hybrid approach involves stenting of the arterial duct or prostaglandin therapy to maintain systemic perfusion combined with off-pump bilateral banding of the pulmonary arteries (bPAB) in the neonatal period. The Giessen hybrid operation defers the Norwood-type palliation using cardiopulmonary bypass that involves an aortic arch reconstruction, including a superior cavopulmonary connection or a biventricular correction, if indicated, until the infant is 4-8 months of age.
“In recent years, hybrid treatment has moved from a myth to an alternative modality in a growing number of institutions globally,” Dr. Yerebakan and colleagues said. The hybrid procedure has been used in high-risk patients. One report claimed higher morbidity in the hybrid procedure due to bPAB (Ann Thorac Surg. 2013;96:1382-8). Another study raised concerns about an adequate pulmonary artery rehabilitation at the time of the Fontan operation, the third stage in the hybrid strategy (J Thorac Cardiovasc Surg. 2014;147:706-12).
But with the hybrid approach, patients retain the potential to receive a biventricular correction up to 8 months later without compromising survival, “postponing an immediate definitive decision in the newborn period in comparison with the classic Norwood palliation,” Dr. Yerebakan and coauthors noted.
The doctors at the Pediatric Heart Center Giessen treat all types and variants of HLHS with the modified Giessen hybrid strategy. Between 1998 and 2015, 182 patients with HLHS had the Giessen hybrid stage I operation, including 126 patients who received univentricular palliation or a heart transplant. The median age of stage I recipients was 6 days, and median weight 3.2 kg. The stage II operation was performed at 4.5 months, with a range of 2.9 to 39.5 months, and Fontan completion was established at 33.7 months, with a range of 21 to 108 months.
Median follow-up after the stage I procedure was 4.6 years, and the death rate was 2.5%. After stage II, mortality was 4.9%; no deaths were reported after Fontan completion. Body weight less than 2.5 kg and aortic atresia had no significant effect on survival. Mortality rates were 8.9% between stages I and II and 5.3% between stage II and Fontan completion. “Cumulative interstage mortality was 14.2%,” Dr. Yerebakan and colleagues noted. “At 10 years, the probability of survival is 77.8%.”
Also at 10 years, 32.2% of patients were free from further pulmonary artery intervention, and 16.7% needed aortic arch reconstruction. Two patients required reoperations for aortic arch reconstruction.
Dr. Yerebakan and colleagues suggested several steps to improve outcomes with the hybrid approach: “intense collaboration” with anesthesiology and pediatric cardiology during and after the procedure to risk stratify individual patients; implementation of standards for management of all stages, including out-of-hospital care, in all departments that participate in a case; and liberalized indications for use of MRI before the stage II and Fontan completion.
Among the limitations of the study the authors noted were its retrospective nature and a median follow-up of only 5 years when the center has some cases with up to 15 years of follow-up. But Dr. Yerebakan and coauthors said they could not determine if the patients benefit from the hybrid treatment in the long-term.
The researchers had no disclosures.
The study by Dr. Yerebakan and colleagues is one of the largest single-center series of patients with HLHS who routinely undergo a hybrid palliation to date, and while the study is open to criticisms, “the authors should be applauded,” Dr. Ralph S. Mosca of New York University said in his invited commentary (J Thorac Cardiovasc Surg. 2016;151:1123-25).
Among the criticisms Dr. Mosca mentioned are that the hybrid approach requires a more extensive stage II reconstruction, “often further complicated by the presence of significant branch PA stenosis and a difficult aortic arch reconstruction”; that there is “appreciable” interstage mortality at 12.2%; and that there is an absence of data on renal or respiratory insufficiency, infection rates, and neurologic outcomes.
Dr. Mosca cited the cause for applause, however: “Through their persistence and collective experience, [the authors] have achieved commendable results in this difficult patient population.”
Yet, Dr. Mosca also noted a number of “potential problems” with the hybrid approach: bilateral banding of the pulmonary artery is a “crude procedure”; arterial duct stenting can lead to retrograde aortic arch reduction; and the interstage mortality “remains significant.”
Results of the hybrid and Norwood procedures are “strikingly similar,” Dr. Mosca said. While the hybrid approach may lower neonatal mortality, it may also carry longer-term consequences “predicated upon the need to closely observe and intervene,” he said. Clinicians need more information on hybrid outcomes, but in time it will likely take its place as an option for HLHS alongside the Norwood procedure, Dr. Mosca said.
The study by Dr. Yerebakan and colleagues is one of the largest single-center series of patients with HLHS who routinely undergo a hybrid palliation to date, and while the study is open to criticisms, “the authors should be applauded,” Dr. Ralph S. Mosca of New York University said in his invited commentary (J Thorac Cardiovasc Surg. 2016;151:1123-25).
Among the criticisms Dr. Mosca mentioned are that the hybrid approach requires a more extensive stage II reconstruction, “often further complicated by the presence of significant branch PA stenosis and a difficult aortic arch reconstruction”; that there is “appreciable” interstage mortality at 12.2%; and that there is an absence of data on renal or respiratory insufficiency, infection rates, and neurologic outcomes.
Dr. Mosca cited the cause for applause, however: “Through their persistence and collective experience, [the authors] have achieved commendable results in this difficult patient population.”
Yet, Dr. Mosca also noted a number of “potential problems” with the hybrid approach: bilateral banding of the pulmonary artery is a “crude procedure”; arterial duct stenting can lead to retrograde aortic arch reduction; and the interstage mortality “remains significant.”
Results of the hybrid and Norwood procedures are “strikingly similar,” Dr. Mosca said. While the hybrid approach may lower neonatal mortality, it may also carry longer-term consequences “predicated upon the need to closely observe and intervene,” he said. Clinicians need more information on hybrid outcomes, but in time it will likely take its place as an option for HLHS alongside the Norwood procedure, Dr. Mosca said.
The study by Dr. Yerebakan and colleagues is one of the largest single-center series of patients with HLHS who routinely undergo a hybrid palliation to date, and while the study is open to criticisms, “the authors should be applauded,” Dr. Ralph S. Mosca of New York University said in his invited commentary (J Thorac Cardiovasc Surg. 2016;151:1123-25).
Among the criticisms Dr. Mosca mentioned are that the hybrid approach requires a more extensive stage II reconstruction, “often further complicated by the presence of significant branch PA stenosis and a difficult aortic arch reconstruction”; that there is “appreciable” interstage mortality at 12.2%; and that there is an absence of data on renal or respiratory insufficiency, infection rates, and neurologic outcomes.
Dr. Mosca cited the cause for applause, however: “Through their persistence and collective experience, [the authors] have achieved commendable results in this difficult patient population.”
Yet, Dr. Mosca also noted a number of “potential problems” with the hybrid approach: bilateral banding of the pulmonary artery is a “crude procedure”; arterial duct stenting can lead to retrograde aortic arch reduction; and the interstage mortality “remains significant.”
Results of the hybrid and Norwood procedures are “strikingly similar,” Dr. Mosca said. While the hybrid approach may lower neonatal mortality, it may also carry longer-term consequences “predicated upon the need to closely observe and intervene,” he said. Clinicians need more information on hybrid outcomes, but in time it will likely take its place as an option for HLHS alongside the Norwood procedure, Dr. Mosca said.
Although the classic Norwood palliation for infants with hypoplastic left heart syndrome (HLHS) has been well established, the procedure has had its drawbacks, namely the need for cardiopulmonary bypass with hypothermia and a because it rules out biventricular correction months later. A hybrid procedure avoids the need for bypass and accommodates short-term biventricular correction, but it has lacked strong evidence.
Researchers from Justus-Liebig University Giessen, Germany, reported on 182 patients with HLHS who had the three-stage Giessen hybrid procedure, noting 10-year survival of almost 80% with almost a third of patients requiring no artery intervention in that time (J Thorac Cardiovasc Surg. 2016 April;151:1112-23).
“In view of the early results and long-term outcome after Giessen hybrid palliation, the hybrid approach has become a reasonable alternative to the conventional strategy to treat neonates with HLHS and variants,” wrote Dr. Can Yerebakan and colleagues. “Further refinements are warranted to decrease patient morbidity.”
The Giessen hybrid procedure uses a technique to control pulmonary blood flow that is different from the Norwood procedure. The hybrid approach involves stenting of the arterial duct or prostaglandin therapy to maintain systemic perfusion combined with off-pump bilateral banding of the pulmonary arteries (bPAB) in the neonatal period. The Giessen hybrid operation defers the Norwood-type palliation using cardiopulmonary bypass that involves an aortic arch reconstruction, including a superior cavopulmonary connection or a biventricular correction, if indicated, until the infant is 4-8 months of age.
“In recent years, hybrid treatment has moved from a myth to an alternative modality in a growing number of institutions globally,” Dr. Yerebakan and colleagues said. The hybrid procedure has been used in high-risk patients. One report claimed higher morbidity in the hybrid procedure due to bPAB (Ann Thorac Surg. 2013;96:1382-8). Another study raised concerns about an adequate pulmonary artery rehabilitation at the time of the Fontan operation, the third stage in the hybrid strategy (J Thorac Cardiovasc Surg. 2014;147:706-12).
But with the hybrid approach, patients retain the potential to receive a biventricular correction up to 8 months later without compromising survival, “postponing an immediate definitive decision in the newborn period in comparison with the classic Norwood palliation,” Dr. Yerebakan and coauthors noted.
The doctors at the Pediatric Heart Center Giessen treat all types and variants of HLHS with the modified Giessen hybrid strategy. Between 1998 and 2015, 182 patients with HLHS had the Giessen hybrid stage I operation, including 126 patients who received univentricular palliation or a heart transplant. The median age of stage I recipients was 6 days, and median weight 3.2 kg. The stage II operation was performed at 4.5 months, with a range of 2.9 to 39.5 months, and Fontan completion was established at 33.7 months, with a range of 21 to 108 months.
Median follow-up after the stage I procedure was 4.6 years, and the death rate was 2.5%. After stage II, mortality was 4.9%; no deaths were reported after Fontan completion. Body weight less than 2.5 kg and aortic atresia had no significant effect on survival. Mortality rates were 8.9% between stages I and II and 5.3% between stage II and Fontan completion. “Cumulative interstage mortality was 14.2%,” Dr. Yerebakan and colleagues noted. “At 10 years, the probability of survival is 77.8%.”
Also at 10 years, 32.2% of patients were free from further pulmonary artery intervention, and 16.7% needed aortic arch reconstruction. Two patients required reoperations for aortic arch reconstruction.
Dr. Yerebakan and colleagues suggested several steps to improve outcomes with the hybrid approach: “intense collaboration” with anesthesiology and pediatric cardiology during and after the procedure to risk stratify individual patients; implementation of standards for management of all stages, including out-of-hospital care, in all departments that participate in a case; and liberalized indications for use of MRI before the stage II and Fontan completion.
Among the limitations of the study the authors noted were its retrospective nature and a median follow-up of only 5 years when the center has some cases with up to 15 years of follow-up. But Dr. Yerebakan and coauthors said they could not determine if the patients benefit from the hybrid treatment in the long-term.
The researchers had no disclosures.
Although the classic Norwood palliation for infants with hypoplastic left heart syndrome (HLHS) has been well established, the procedure has had its drawbacks, namely the need for cardiopulmonary bypass with hypothermia and a because it rules out biventricular correction months later. A hybrid procedure avoids the need for bypass and accommodates short-term biventricular correction, but it has lacked strong evidence.
Researchers from Justus-Liebig University Giessen, Germany, reported on 182 patients with HLHS who had the three-stage Giessen hybrid procedure, noting 10-year survival of almost 80% with almost a third of patients requiring no artery intervention in that time (J Thorac Cardiovasc Surg. 2016 April;151:1112-23).
“In view of the early results and long-term outcome after Giessen hybrid palliation, the hybrid approach has become a reasonable alternative to the conventional strategy to treat neonates with HLHS and variants,” wrote Dr. Can Yerebakan and colleagues. “Further refinements are warranted to decrease patient morbidity.”
The Giessen hybrid procedure uses a technique to control pulmonary blood flow that is different from the Norwood procedure. The hybrid approach involves stenting of the arterial duct or prostaglandin therapy to maintain systemic perfusion combined with off-pump bilateral banding of the pulmonary arteries (bPAB) in the neonatal period. The Giessen hybrid operation defers the Norwood-type palliation using cardiopulmonary bypass that involves an aortic arch reconstruction, including a superior cavopulmonary connection or a biventricular correction, if indicated, until the infant is 4-8 months of age.
“In recent years, hybrid treatment has moved from a myth to an alternative modality in a growing number of institutions globally,” Dr. Yerebakan and colleagues said. The hybrid procedure has been used in high-risk patients. One report claimed higher morbidity in the hybrid procedure due to bPAB (Ann Thorac Surg. 2013;96:1382-8). Another study raised concerns about an adequate pulmonary artery rehabilitation at the time of the Fontan operation, the third stage in the hybrid strategy (J Thorac Cardiovasc Surg. 2014;147:706-12).
But with the hybrid approach, patients retain the potential to receive a biventricular correction up to 8 months later without compromising survival, “postponing an immediate definitive decision in the newborn period in comparison with the classic Norwood palliation,” Dr. Yerebakan and coauthors noted.
The doctors at the Pediatric Heart Center Giessen treat all types and variants of HLHS with the modified Giessen hybrid strategy. Between 1998 and 2015, 182 patients with HLHS had the Giessen hybrid stage I operation, including 126 patients who received univentricular palliation or a heart transplant. The median age of stage I recipients was 6 days, and median weight 3.2 kg. The stage II operation was performed at 4.5 months, with a range of 2.9 to 39.5 months, and Fontan completion was established at 33.7 months, with a range of 21 to 108 months.
Median follow-up after the stage I procedure was 4.6 years, and the death rate was 2.5%. After stage II, mortality was 4.9%; no deaths were reported after Fontan completion. Body weight less than 2.5 kg and aortic atresia had no significant effect on survival. Mortality rates were 8.9% between stages I and II and 5.3% between stage II and Fontan completion. “Cumulative interstage mortality was 14.2%,” Dr. Yerebakan and colleagues noted. “At 10 years, the probability of survival is 77.8%.”
Also at 10 years, 32.2% of patients were free from further pulmonary artery intervention, and 16.7% needed aortic arch reconstruction. Two patients required reoperations for aortic arch reconstruction.
Dr. Yerebakan and colleagues suggested several steps to improve outcomes with the hybrid approach: “intense collaboration” with anesthesiology and pediatric cardiology during and after the procedure to risk stratify individual patients; implementation of standards for management of all stages, including out-of-hospital care, in all departments that participate in a case; and liberalized indications for use of MRI before the stage II and Fontan completion.
Among the limitations of the study the authors noted were its retrospective nature and a median follow-up of only 5 years when the center has some cases with up to 15 years of follow-up. But Dr. Yerebakan and coauthors said they could not determine if the patients benefit from the hybrid treatment in the long-term.
The researchers had no disclosures.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: A hybrid operation for hypoplastic left heart syndrome (HLHS) and variants in neonates is emerging as an alternative to the Norwood palliation.
Major finding: At 10 years, the probability of survival with the hybrid procedure was 77.8%. Low body weight (less than 2.5 kg) and aortic atresia had no significant impact on survival.
Data source: Retrospective study of 182 patients who had the hybrid procedure at a single center between June 1998 and February 2015.
Disclosures: The study investigators had no relationships to disclose.
Surgeons commonly off the mark in estimating blood loss
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Surgery, anesthesia, and nursing providers were inaccurate and unreliable in estimating surgical blood loss.
Major finding: Only 5% of providers could come within 25% accuracy of simulated surgical blood loss.
Data source: Simulations of surgical scenarios depicting varying amounts of blood loss using porcine blood, presented to 60 providers.
Disclosures: The study authors reported no relevant disclosures.
Similarities seen in rate and rhythm control for postsurgical AF
CHICAGO – Rate and rhythm control proved equally effective for treatment of new-onset post–cardiac surgery atrial fibrillation in a randomized trial that was far and away the largest ever to examine the best way to address this common and costly arrhythmia, Dr. A. Marc Gillinov said at the annual meeting of the American College of Cardiology.
Thus, either strategy is acceptable. That being said, rate control gets the edge as the initial treatment strategy because it avoids the considerable toxicities accompanying amiodarone for rhythm control, most of which arise only after patients have been discharged from the hospital. In contrast, when rate control doesn’t work, it becomes evident while the patient is still in the hospital, according to Dr. Gillinov, a cardiothoracic surgeon at the Cleveland Clinic .
Atrial fibrillation (AF) is the most common complication of cardiac surgery, with an incidence variously reported at 20%-50%. It results in lengthier hospital stays, greater cost of care, and increased risks of mortality, stroke, heart failure, and infection. Postoperative AF adds an estimated $1 billion per year to health care costs in the United States.
While current ACC/AHA/Heart Rhythm Society joint guidelines recommend rate control with a beta-blocker as first-line therapy for patients with this postoperative complication, with a class I, level-of-evidence A rating, upon closer inspection the evidence cited mainly involves extrapolation from studies looking at how to prevent postoperative AF. Because no persuasive evidence existed as to how best to treat this common and economically and medically costly condition, Dr. Gillinov and his coinvestigators in the National Institutes of Health–funded Cardiothoracic Surgical Trials Network carried out a randomized trial 10-fold larger than anything prior.
The 23-site study included 2,109 patients enrolled prior to cardiac surgery, of whom 40% underwent isolated coronary artery bypass grafting (CABG) while the other 60% had valve surgery, either alone or with CABG. These proportions reflect current cardiac surgery treatment patterns nationally. Overall, 33% of the cardiac surgery patients experienced postoperative AF. The incidence was 28% in patients who underwent isolated CABG but rose with increasing surgical complexity to nearly 50% in patients who had combined CABG and valve operations. The average time to onset of postoperative AF was 2.4 days.
A total of 523 patients with postoperative AF were randomized to rate or rhythm control. Rate control most often entailed use of a beta-blocker, while amiodarone was prescribed for rhythm control.
The primary endpoint in the trial was a measure of health care resource utilization: total days in hospital during a 60-day period starting from the time of randomization. This endpoint was a draw: a median of 5.1 days with rate control and 5.0 days with rhythm control.
At hospital discharge, 89.9% of patients in the rate control group and 93.5% in the rhythm control group had a stable heart rhythm without AF. From discharge to 60 days, 84.2% of patients in the rate control group and a similar 86.9% of the rhythm control group remained free of AF.
Rates of serious adverse events were similar in the two groups: 24.8 per 100 patient-months in the rate control arm and 26.4 per 100 patient-months in the rhythm control arm. Three patients in the rate control arm died during the 60-day study period, and two died in the rhythm control group.
Of note, roughly one-quarter of patients in each study arm crossed over to the other arm. In the rate control group, this was typically due to drug ineffectiveness, while in the rhythm control arm the switch was most often made in response to amiodarone side effects.
Roughly 43% of patients in each group were placed on anticoagulation with warfarin for 60 days according to study protocol, which called for such action if a patient remained in AF 48 hours after randomization.
There were five strokes, one case of transient ischemic attack, and four noncerebral thromboembolisms. Also, 21 bleeding events occurred, 17 of which were classified as serious; 90% of the bleeding events happened in patients on warfarin.
“I found the results very striking and very reassuring,” said discussant Hugh G. Calkins. “To me, the clinical message is clearly that rate control is the preference.”
It was troubling, however, to see that 10 thromboembolic events occurred in 523 patients over the course of just 60 days. “Should we be anticoagulating these postsurgical atrial fibrillation patients a lot more frequently?” asked Dr. Calkins, professor of medicine and of pediatrics and director of the cardiac arrhythmia service at Johns Hopkins University, Baltimore.
Dr. Gillinov replied that he and his colleagues in the Cardiothoracic Surgical Trials Network consider that to be the key remaining question regarding postoperative AF. They are now planning a clinical trial aimed at finding the optimal balance between stroke protection via anticoagulation and bleeding risk.
The National Institutes of Health and the Canadian Institutes of Health Research funded the work. Dr. Gillinov reported serving as a consultant to five surgical device companies, none of which played any role in the study.
Simultaneously with Dr. Gillinov’s presentation at ACC 16, the study results were published in the New England Journal of Medicine (doi: 10.1056/NEJMoa1602002).
CHICAGO – Rate and rhythm control proved equally effective for treatment of new-onset post–cardiac surgery atrial fibrillation in a randomized trial that was far and away the largest ever to examine the best way to address this common and costly arrhythmia, Dr. A. Marc Gillinov said at the annual meeting of the American College of Cardiology.
Thus, either strategy is acceptable. That being said, rate control gets the edge as the initial treatment strategy because it avoids the considerable toxicities accompanying amiodarone for rhythm control, most of which arise only after patients have been discharged from the hospital. In contrast, when rate control doesn’t work, it becomes evident while the patient is still in the hospital, according to Dr. Gillinov, a cardiothoracic surgeon at the Cleveland Clinic .
Atrial fibrillation (AF) is the most common complication of cardiac surgery, with an incidence variously reported at 20%-50%. It results in lengthier hospital stays, greater cost of care, and increased risks of mortality, stroke, heart failure, and infection. Postoperative AF adds an estimated $1 billion per year to health care costs in the United States.
While current ACC/AHA/Heart Rhythm Society joint guidelines recommend rate control with a beta-blocker as first-line therapy for patients with this postoperative complication, with a class I, level-of-evidence A rating, upon closer inspection the evidence cited mainly involves extrapolation from studies looking at how to prevent postoperative AF. Because no persuasive evidence existed as to how best to treat this common and economically and medically costly condition, Dr. Gillinov and his coinvestigators in the National Institutes of Health–funded Cardiothoracic Surgical Trials Network carried out a randomized trial 10-fold larger than anything prior.
The 23-site study included 2,109 patients enrolled prior to cardiac surgery, of whom 40% underwent isolated coronary artery bypass grafting (CABG) while the other 60% had valve surgery, either alone or with CABG. These proportions reflect current cardiac surgery treatment patterns nationally. Overall, 33% of the cardiac surgery patients experienced postoperative AF. The incidence was 28% in patients who underwent isolated CABG but rose with increasing surgical complexity to nearly 50% in patients who had combined CABG and valve operations. The average time to onset of postoperative AF was 2.4 days.
A total of 523 patients with postoperative AF were randomized to rate or rhythm control. Rate control most often entailed use of a beta-blocker, while amiodarone was prescribed for rhythm control.
The primary endpoint in the trial was a measure of health care resource utilization: total days in hospital during a 60-day period starting from the time of randomization. This endpoint was a draw: a median of 5.1 days with rate control and 5.0 days with rhythm control.
At hospital discharge, 89.9% of patients in the rate control group and 93.5% in the rhythm control group had a stable heart rhythm without AF. From discharge to 60 days, 84.2% of patients in the rate control group and a similar 86.9% of the rhythm control group remained free of AF.
Rates of serious adverse events were similar in the two groups: 24.8 per 100 patient-months in the rate control arm and 26.4 per 100 patient-months in the rhythm control arm. Three patients in the rate control arm died during the 60-day study period, and two died in the rhythm control group.
Of note, roughly one-quarter of patients in each study arm crossed over to the other arm. In the rate control group, this was typically due to drug ineffectiveness, while in the rhythm control arm the switch was most often made in response to amiodarone side effects.
Roughly 43% of patients in each group were placed on anticoagulation with warfarin for 60 days according to study protocol, which called for such action if a patient remained in AF 48 hours after randomization.
There were five strokes, one case of transient ischemic attack, and four noncerebral thromboembolisms. Also, 21 bleeding events occurred, 17 of which were classified as serious; 90% of the bleeding events happened in patients on warfarin.
“I found the results very striking and very reassuring,” said discussant Hugh G. Calkins. “To me, the clinical message is clearly that rate control is the preference.”
It was troubling, however, to see that 10 thromboembolic events occurred in 523 patients over the course of just 60 days. “Should we be anticoagulating these postsurgical atrial fibrillation patients a lot more frequently?” asked Dr. Calkins, professor of medicine and of pediatrics and director of the cardiac arrhythmia service at Johns Hopkins University, Baltimore.
Dr. Gillinov replied that he and his colleagues in the Cardiothoracic Surgical Trials Network consider that to be the key remaining question regarding postoperative AF. They are now planning a clinical trial aimed at finding the optimal balance between stroke protection via anticoagulation and bleeding risk.
The National Institutes of Health and the Canadian Institutes of Health Research funded the work. Dr. Gillinov reported serving as a consultant to five surgical device companies, none of which played any role in the study.
Simultaneously with Dr. Gillinov’s presentation at ACC 16, the study results were published in the New England Journal of Medicine (doi: 10.1056/NEJMoa1602002).
CHICAGO – Rate and rhythm control proved equally effective for treatment of new-onset post–cardiac surgery atrial fibrillation in a randomized trial that was far and away the largest ever to examine the best way to address this common and costly arrhythmia, Dr. A. Marc Gillinov said at the annual meeting of the American College of Cardiology.
Thus, either strategy is acceptable. That being said, rate control gets the edge as the initial treatment strategy because it avoids the considerable toxicities accompanying amiodarone for rhythm control, most of which arise only after patients have been discharged from the hospital. In contrast, when rate control doesn’t work, it becomes evident while the patient is still in the hospital, according to Dr. Gillinov, a cardiothoracic surgeon at the Cleveland Clinic .
Atrial fibrillation (AF) is the most common complication of cardiac surgery, with an incidence variously reported at 20%-50%. It results in lengthier hospital stays, greater cost of care, and increased risks of mortality, stroke, heart failure, and infection. Postoperative AF adds an estimated $1 billion per year to health care costs in the United States.
While current ACC/AHA/Heart Rhythm Society joint guidelines recommend rate control with a beta-blocker as first-line therapy for patients with this postoperative complication, with a class I, level-of-evidence A rating, upon closer inspection the evidence cited mainly involves extrapolation from studies looking at how to prevent postoperative AF. Because no persuasive evidence existed as to how best to treat this common and economically and medically costly condition, Dr. Gillinov and his coinvestigators in the National Institutes of Health–funded Cardiothoracic Surgical Trials Network carried out a randomized trial 10-fold larger than anything prior.
The 23-site study included 2,109 patients enrolled prior to cardiac surgery, of whom 40% underwent isolated coronary artery bypass grafting (CABG) while the other 60% had valve surgery, either alone or with CABG. These proportions reflect current cardiac surgery treatment patterns nationally. Overall, 33% of the cardiac surgery patients experienced postoperative AF. The incidence was 28% in patients who underwent isolated CABG but rose with increasing surgical complexity to nearly 50% in patients who had combined CABG and valve operations. The average time to onset of postoperative AF was 2.4 days.
A total of 523 patients with postoperative AF were randomized to rate or rhythm control. Rate control most often entailed use of a beta-blocker, while amiodarone was prescribed for rhythm control.
The primary endpoint in the trial was a measure of health care resource utilization: total days in hospital during a 60-day period starting from the time of randomization. This endpoint was a draw: a median of 5.1 days with rate control and 5.0 days with rhythm control.
At hospital discharge, 89.9% of patients in the rate control group and 93.5% in the rhythm control group had a stable heart rhythm without AF. From discharge to 60 days, 84.2% of patients in the rate control group and a similar 86.9% of the rhythm control group remained free of AF.
Rates of serious adverse events were similar in the two groups: 24.8 per 100 patient-months in the rate control arm and 26.4 per 100 patient-months in the rhythm control arm. Three patients in the rate control arm died during the 60-day study period, and two died in the rhythm control group.
Of note, roughly one-quarter of patients in each study arm crossed over to the other arm. In the rate control group, this was typically due to drug ineffectiveness, while in the rhythm control arm the switch was most often made in response to amiodarone side effects.
Roughly 43% of patients in each group were placed on anticoagulation with warfarin for 60 days according to study protocol, which called for such action if a patient remained in AF 48 hours after randomization.
There were five strokes, one case of transient ischemic attack, and four noncerebral thromboembolisms. Also, 21 bleeding events occurred, 17 of which were classified as serious; 90% of the bleeding events happened in patients on warfarin.
“I found the results very striking and very reassuring,” said discussant Hugh G. Calkins. “To me, the clinical message is clearly that rate control is the preference.”
It was troubling, however, to see that 10 thromboembolic events occurred in 523 patients over the course of just 60 days. “Should we be anticoagulating these postsurgical atrial fibrillation patients a lot more frequently?” asked Dr. Calkins, professor of medicine and of pediatrics and director of the cardiac arrhythmia service at Johns Hopkins University, Baltimore.
Dr. Gillinov replied that he and his colleagues in the Cardiothoracic Surgical Trials Network consider that to be the key remaining question regarding postoperative AF. They are now planning a clinical trial aimed at finding the optimal balance between stroke protection via anticoagulation and bleeding risk.
The National Institutes of Health and the Canadian Institutes of Health Research funded the work. Dr. Gillinov reported serving as a consultant to five surgical device companies, none of which played any role in the study.
Simultaneously with Dr. Gillinov’s presentation at ACC 16, the study results were published in the New England Journal of Medicine (doi: 10.1056/NEJMoa1602002).
AT ACC 16
Key clinical point: Rate control offers the advantage of simplicity over a rhythm control strategy in new-onset atrial fibrillation after cardiac surgery.
Major finding: Rate and rhythm control strategies for treatment of new-onset atrial fibrillation after cardiac surgery resulted in equal numbers of hospital days, similar serious complication rates, and low rates of persistent atrial fibrillation at 60 days of follow-up.
Data source: A randomized clinical trial of 523 patients with new-onset atrial fibrillation following cardiac surgery at 23 U.S. and Canadian academic medical centers.
Disclosures: The study was funded by the National Institutes of Health and the Canadian Institutes of Health Research and carried out through the Cardiothoracic Surgical Trials Network. The presenter reported having no relevant financial interests.
VIDEO: STICHES trial update boosts CABG in ischemic cardiomyopathy
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ACC 16
VIDEO: STICHES trial update boosts CABG in ischemic cardiomyopathy
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ACC 16
Risk score predicts rehospitalization after heart surgery
PHOENIX – A simple, five-element formula can help identify the patients undergoing heart surgery who face the greatest risk for a hospital readmission within 30 days following discharge from their index hospitalization.
The surgeons who developed this formula hope to use it in an investigational program that will target intensified management resources in postsurgical patients who face the highest readmission risk, to cut rehospitalizations and better improve their clinical status and quality of life.
The analysis that produced this formula also documented that the worst offender for triggering rehospitalizations following heart surgery is fluid overload, the proximate readmission cause for 23% of postsurgical patients, Dr. Arman Kilic said at the annual meeting of the Society of Thoracic Surgeons. The next most common cause was infection, which led to 20% of readmissions, followed by arrhythmias, responsible for 8% of readmissions, said Dr. Kilic, a thoracic surgeon at the University of Pennsylvania in Philadelphia.
Because fluid overload, often in the form of pleural effusion, is such an important driver of rehospitalizations, a more targeted management program would include better titration of diuretic treatment to patients following heart surgery, thoracentesis, and closer monitoring of clinical features that flag fluid overload such as weight.
“The volume overload issue is where the money is. If we can reduce that, it could really impact readmissions,” Dr. Kilic said in an interview.
An investigational program to target rehospitalization risk in heart surgery patients is planned at Johns Hopkins Hospital in Baltimore, where Dr. Kilic worked when he performed this analysis. Surgeons at Johns Hopkins are now in the process of getting funding for this pilot program, said Dr. John V. Conte Jr., professor of surgery and director of mechanical circulatory support at Johns Hopkins and a collaborator with Dr. Kilic on developing the risk formula.
“We’ll tailor postoperative follow-up. We’ll get high-risk patients back to the clinic sooner, and we’ll send nurse practitioners to see them to make sure they’re taking their medications and are getting weighed daily,” Dr. Conte said in an interview. “When a patient has heart surgery, they typically retain about 5-10 pounds of fluid. Patients with good renal function give up that fluid easily, but others are difficult to diurese. Many patients go home before they have been fully diuresed, and we need to follow these patients and transition them better to out-of-hospital care.”
He noted that other situations also come up that unnecessarily drive patients back to the hospital when an alternative and less expensive intervention might be equally effective. For example, some patients return to the hospital out of concern for how their chest wound is healing. Instead of being rehospitalized, such patients could be reassured by having them send a nurse a photo of their wound or by coming to an outpatient clinic.
“We need to engage more often with recently discharged patients,” Dr. Conte said in an interview. “Discharging them doesn’t mean separating them from the health care system; it should mean interacting with patients in a different way” that produces better outcomes and patient satisfaction for less money. Developing improved ways to manage recent heart surgery patients following discharge becomes even more critical later this year when, in July, the Centers for Medicare & Medicaid Services adds 30-day readmissions following coronary artery bypass grafting (CABG) to its list of procedures that can generate a penalty to hospitals if they exceed U.S. norms for readmission rates.
The risk model developed by Dr. Kilic, Dr. Conte, and their associates used data collected from 5,360 heart surgery patients treated at Johns Hopkins during 2008-2013. Nearly half the patients underwent isolated CABG, and 20% had isolated valve surgery. Overall, 585 patients (11%) had a hospital readmission within 30 days of their index discharge. One limitation of the analysis was it used data only on readmissions back to Johns Hopkins Hospital.
The researchers used data from three-quarters of the database to derive the risk formula, and from the remaining 25% of the database to validate the formula. A multivariate analysis of demographic and clinical characteristics that significantly linked with an elevated risk for readmissions identified five factors that independently made a significant contribution to readmission risk. The researchers assigned each of these five factors points depending on its relative contribution to readmission risk in the adjusted model: Severe chronic lung disease received 6 points; placement of a ventricular assist device received 5 points, while other types of heart surgery that was not CABG or valve surgery received 4 points (isolated CABG, isolated valve, or combined CABG and valve surgery received 0 points); development of acute renal failure postoperatively but before index discharge received 4 points; an index length of stay beyond 7 days received 4 points; and African American race received 3 points. The maximum number of points a patient could receive was 22.
Patients with a score of 0 had a 6% rate of a 30-day readmission; those with a score of 22 had a 63% readmission rate. For simplicity, Dr. Kilic suggested dividing patients into three categories based on their readmission risk score: Low-risk patients with a score of 0 had a readmission risk of 6%, medium-risk patients with a score of 1-10 had a readmission risk of 12%, and high-risk patients with a score of 11 or more had a readmission risk of 31%. The researchers found a 96% correlation when comparing these predicted readmission risk rates based on the derivation-subgroup analysis with the actual readmission rates seen in the validation subgroup of their database. The targeted risk-management program planned by Dr. Conte would primarily focus on high-risk patients.
Dr. Kilic and Dr. Conte said they had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
Dr. Kilic's data illustrates common factors resulting in rehospitalization after cardiac surgery. Fastidious fluid management in these patients and others is critical to reduce hospital readmissions. A further point to consider is that many pleural effusions, especially those on the left side, are due to retained hemothorax rather than fluid overload. In those instances, early surgical intervention with video-assisted thoracoscopic surgery, rather than prolonged diuresis, would be optimal.
Dr. Francis J. Podbielski, FCCP, serves on the editorial advisory board for CHEST Physician.
Dr. Kilic's data illustrates common factors resulting in rehospitalization after cardiac surgery. Fastidious fluid management in these patients and others is critical to reduce hospital readmissions. A further point to consider is that many pleural effusions, especially those on the left side, are due to retained hemothorax rather than fluid overload. In those instances, early surgical intervention with video-assisted thoracoscopic surgery, rather than prolonged diuresis, would be optimal.
Dr. Francis J. Podbielski, FCCP, serves on the editorial advisory board for CHEST Physician.
Dr. Kilic's data illustrates common factors resulting in rehospitalization after cardiac surgery. Fastidious fluid management in these patients and others is critical to reduce hospital readmissions. A further point to consider is that many pleural effusions, especially those on the left side, are due to retained hemothorax rather than fluid overload. In those instances, early surgical intervention with video-assisted thoracoscopic surgery, rather than prolonged diuresis, would be optimal.
Dr. Francis J. Podbielski, FCCP, serves on the editorial advisory board for CHEST Physician.
PHOENIX – A simple, five-element formula can help identify the patients undergoing heart surgery who face the greatest risk for a hospital readmission within 30 days following discharge from their index hospitalization.
The surgeons who developed this formula hope to use it in an investigational program that will target intensified management resources in postsurgical patients who face the highest readmission risk, to cut rehospitalizations and better improve their clinical status and quality of life.
The analysis that produced this formula also documented that the worst offender for triggering rehospitalizations following heart surgery is fluid overload, the proximate readmission cause for 23% of postsurgical patients, Dr. Arman Kilic said at the annual meeting of the Society of Thoracic Surgeons. The next most common cause was infection, which led to 20% of readmissions, followed by arrhythmias, responsible for 8% of readmissions, said Dr. Kilic, a thoracic surgeon at the University of Pennsylvania in Philadelphia.
Because fluid overload, often in the form of pleural effusion, is such an important driver of rehospitalizations, a more targeted management program would include better titration of diuretic treatment to patients following heart surgery, thoracentesis, and closer monitoring of clinical features that flag fluid overload such as weight.
“The volume overload issue is where the money is. If we can reduce that, it could really impact readmissions,” Dr. Kilic said in an interview.
An investigational program to target rehospitalization risk in heart surgery patients is planned at Johns Hopkins Hospital in Baltimore, where Dr. Kilic worked when he performed this analysis. Surgeons at Johns Hopkins are now in the process of getting funding for this pilot program, said Dr. John V. Conte Jr., professor of surgery and director of mechanical circulatory support at Johns Hopkins and a collaborator with Dr. Kilic on developing the risk formula.
“We’ll tailor postoperative follow-up. We’ll get high-risk patients back to the clinic sooner, and we’ll send nurse practitioners to see them to make sure they’re taking their medications and are getting weighed daily,” Dr. Conte said in an interview. “When a patient has heart surgery, they typically retain about 5-10 pounds of fluid. Patients with good renal function give up that fluid easily, but others are difficult to diurese. Many patients go home before they have been fully diuresed, and we need to follow these patients and transition them better to out-of-hospital care.”
He noted that other situations also come up that unnecessarily drive patients back to the hospital when an alternative and less expensive intervention might be equally effective. For example, some patients return to the hospital out of concern for how their chest wound is healing. Instead of being rehospitalized, such patients could be reassured by having them send a nurse a photo of their wound or by coming to an outpatient clinic.
“We need to engage more often with recently discharged patients,” Dr. Conte said in an interview. “Discharging them doesn’t mean separating them from the health care system; it should mean interacting with patients in a different way” that produces better outcomes and patient satisfaction for less money. Developing improved ways to manage recent heart surgery patients following discharge becomes even more critical later this year when, in July, the Centers for Medicare & Medicaid Services adds 30-day readmissions following coronary artery bypass grafting (CABG) to its list of procedures that can generate a penalty to hospitals if they exceed U.S. norms for readmission rates.
The risk model developed by Dr. Kilic, Dr. Conte, and their associates used data collected from 5,360 heart surgery patients treated at Johns Hopkins during 2008-2013. Nearly half the patients underwent isolated CABG, and 20% had isolated valve surgery. Overall, 585 patients (11%) had a hospital readmission within 30 days of their index discharge. One limitation of the analysis was it used data only on readmissions back to Johns Hopkins Hospital.
The researchers used data from three-quarters of the database to derive the risk formula, and from the remaining 25% of the database to validate the formula. A multivariate analysis of demographic and clinical characteristics that significantly linked with an elevated risk for readmissions identified five factors that independently made a significant contribution to readmission risk. The researchers assigned each of these five factors points depending on its relative contribution to readmission risk in the adjusted model: Severe chronic lung disease received 6 points; placement of a ventricular assist device received 5 points, while other types of heart surgery that was not CABG or valve surgery received 4 points (isolated CABG, isolated valve, or combined CABG and valve surgery received 0 points); development of acute renal failure postoperatively but before index discharge received 4 points; an index length of stay beyond 7 days received 4 points; and African American race received 3 points. The maximum number of points a patient could receive was 22.
Patients with a score of 0 had a 6% rate of a 30-day readmission; those with a score of 22 had a 63% readmission rate. For simplicity, Dr. Kilic suggested dividing patients into three categories based on their readmission risk score: Low-risk patients with a score of 0 had a readmission risk of 6%, medium-risk patients with a score of 1-10 had a readmission risk of 12%, and high-risk patients with a score of 11 or more had a readmission risk of 31%. The researchers found a 96% correlation when comparing these predicted readmission risk rates based on the derivation-subgroup analysis with the actual readmission rates seen in the validation subgroup of their database. The targeted risk-management program planned by Dr. Conte would primarily focus on high-risk patients.
Dr. Kilic and Dr. Conte said they had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
PHOENIX – A simple, five-element formula can help identify the patients undergoing heart surgery who face the greatest risk for a hospital readmission within 30 days following discharge from their index hospitalization.
The surgeons who developed this formula hope to use it in an investigational program that will target intensified management resources in postsurgical patients who face the highest readmission risk, to cut rehospitalizations and better improve their clinical status and quality of life.
The analysis that produced this formula also documented that the worst offender for triggering rehospitalizations following heart surgery is fluid overload, the proximate readmission cause for 23% of postsurgical patients, Dr. Arman Kilic said at the annual meeting of the Society of Thoracic Surgeons. The next most common cause was infection, which led to 20% of readmissions, followed by arrhythmias, responsible for 8% of readmissions, said Dr. Kilic, a thoracic surgeon at the University of Pennsylvania in Philadelphia.
Because fluid overload, often in the form of pleural effusion, is such an important driver of rehospitalizations, a more targeted management program would include better titration of diuretic treatment to patients following heart surgery, thoracentesis, and closer monitoring of clinical features that flag fluid overload such as weight.
“The volume overload issue is where the money is. If we can reduce that, it could really impact readmissions,” Dr. Kilic said in an interview.
An investigational program to target rehospitalization risk in heart surgery patients is planned at Johns Hopkins Hospital in Baltimore, where Dr. Kilic worked when he performed this analysis. Surgeons at Johns Hopkins are now in the process of getting funding for this pilot program, said Dr. John V. Conte Jr., professor of surgery and director of mechanical circulatory support at Johns Hopkins and a collaborator with Dr. Kilic on developing the risk formula.
“We’ll tailor postoperative follow-up. We’ll get high-risk patients back to the clinic sooner, and we’ll send nurse practitioners to see them to make sure they’re taking their medications and are getting weighed daily,” Dr. Conte said in an interview. “When a patient has heart surgery, they typically retain about 5-10 pounds of fluid. Patients with good renal function give up that fluid easily, but others are difficult to diurese. Many patients go home before they have been fully diuresed, and we need to follow these patients and transition them better to out-of-hospital care.”
He noted that other situations also come up that unnecessarily drive patients back to the hospital when an alternative and less expensive intervention might be equally effective. For example, some patients return to the hospital out of concern for how their chest wound is healing. Instead of being rehospitalized, such patients could be reassured by having them send a nurse a photo of their wound or by coming to an outpatient clinic.
“We need to engage more often with recently discharged patients,” Dr. Conte said in an interview. “Discharging them doesn’t mean separating them from the health care system; it should mean interacting with patients in a different way” that produces better outcomes and patient satisfaction for less money. Developing improved ways to manage recent heart surgery patients following discharge becomes even more critical later this year when, in July, the Centers for Medicare & Medicaid Services adds 30-day readmissions following coronary artery bypass grafting (CABG) to its list of procedures that can generate a penalty to hospitals if they exceed U.S. norms for readmission rates.
The risk model developed by Dr. Kilic, Dr. Conte, and their associates used data collected from 5,360 heart surgery patients treated at Johns Hopkins during 2008-2013. Nearly half the patients underwent isolated CABG, and 20% had isolated valve surgery. Overall, 585 patients (11%) had a hospital readmission within 30 days of their index discharge. One limitation of the analysis was it used data only on readmissions back to Johns Hopkins Hospital.
The researchers used data from three-quarters of the database to derive the risk formula, and from the remaining 25% of the database to validate the formula. A multivariate analysis of demographic and clinical characteristics that significantly linked with an elevated risk for readmissions identified five factors that independently made a significant contribution to readmission risk. The researchers assigned each of these five factors points depending on its relative contribution to readmission risk in the adjusted model: Severe chronic lung disease received 6 points; placement of a ventricular assist device received 5 points, while other types of heart surgery that was not CABG or valve surgery received 4 points (isolated CABG, isolated valve, or combined CABG and valve surgery received 0 points); development of acute renal failure postoperatively but before index discharge received 4 points; an index length of stay beyond 7 days received 4 points; and African American race received 3 points. The maximum number of points a patient could receive was 22.
Patients with a score of 0 had a 6% rate of a 30-day readmission; those with a score of 22 had a 63% readmission rate. For simplicity, Dr. Kilic suggested dividing patients into three categories based on their readmission risk score: Low-risk patients with a score of 0 had a readmission risk of 6%, medium-risk patients with a score of 1-10 had a readmission risk of 12%, and high-risk patients with a score of 11 or more had a readmission risk of 31%. The researchers found a 96% correlation when comparing these predicted readmission risk rates based on the derivation-subgroup analysis with the actual readmission rates seen in the validation subgroup of their database. The targeted risk-management program planned by Dr. Conte would primarily focus on high-risk patients.
Dr. Kilic and Dr. Conte said they had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
Key clinical point: A risk score predicted which heart surgery patients faced the greatest risk for hospital readmission within 30 days of their index discharge.
Major finding: Patients with a 0 score had a 6% 30-day readmission rate; a high score of 22 linked with a 63% rate.
Data source: A review of 5,360 heart surgery patients treated at one U.S. center.
Disclosures: Dr. Kilic and Dr. Conte said they had no relevant financial disclosures.
Wanted: Better evidence on fast-track lung resection
A host of medical specialties have adopted strategies to speed recovery of surgical patients, reduce length of hospital stays, and cut costs, known as fast-track or enhanced-recovery pathways, but when it comes to elective lung resection, the medical evidence has yet to establish if patients in expedited recovery protocols fare any better than do those in a conventional recovery course, a systematic review in the March issue of the Journal of Thoracic and Cardiovascular Surgery reported (2016 Mar;151:708-15).
A team of investigators from McGill University in Montreal performed a systematic review of six studies that evaluated patient outcomes of both traditional and enhanced-recovery pathways (ERPs) in elective lung resection. They concluded that ERPs may reduce the length of hospital stays and hospital costs but that well-designed trials are needed to overcome limitations of existing studies.
“The influence of ERPs on postoperative outcomes after lung resection has not been extensively studied in comparative studies involving a control group receiving traditional care,” lead author Julio F. Fiore Jr., Ph.D., and his colleagues said. One of the six studies they reviewed was a randomized clinical trial. The six studies involved a total of 1,612 participants (821 ERP, 791 control).
The researchers also reported that the studies they analyzed shared a significant limitation. “Risk of bias favoring enhanced-recovery pathways was high,” Dr. Fiore and his colleagues wrote. The studies were unclear if patient selection may have factored into the results.
Five studies reported shorter hospital length of stay (LOS) for the ERP group. “The majority of the studies reported that LOS was significantly shorter when patients undergoing lung resection were treated within an ERP, which corroborates the results observed in other surgical populations,” Dr. Fiore and his colleagues said.
Three nonrandomized studies also evaluated costs per patient. Two reported significantly lower costs for ERP patients: $13,093 vs. $14,439 for controls; and $13,432 vs. $17,103 for controls (Jpn. J. Thorac. Cardiovasc. Surg. 2006 Sep;54:387-90; Ann. Thorac. Surg. 1998 Sep;66:914-9). The third showed what the authors said was no statistically significant cost differential between the two groups: $14,792 for ERP vs. $16,063 for controls (Ann. Thorac. Surg. 1997 Aug;64:299-302).
Three studies evaluated readmission rates, but only one showed measurably lower rates for the ERP group: 3% vs. 10% for controls (Lung Cancer. 2012 Dec;78:270-5). Three studies measured complication rates in both groups. Two reported cardiopulmonary complication rates of 18% and 17% in the ERP group vs. 16% and 14% in the control group, respectively (Eur. J. Cardiothorac. Surg. 2012 May;41:1083-7; Lung Cancer. 2012 Dec;78:270-5). One reported rates of pulmonary complications of 7% for ERP vs. 36% for controls (Eur. J. Cardiothorac. Surg. 2008 Jul;34:174-80).
Dr. Fiore and his colleagues pointed out that some of the studies they reviewed were completed before video-assisted thoracic surgery became routine for lung resection. But they acknowledged that research in other surgical specialties have validated the role of ERP, along with minimally invasive surgery, to improve outcomes. “Future research should investigate whether this holds true for patients undergoing lung resection,” they said.
The study authors had no financial relationships to disclose.
The task that Dr. Fiore and colleagues undertook to evaluate and compare disparate studies of fast-track surgery in lung resection is “akin to comparing not just apples and oranges but apples to zucchini,” Dr. Lisa M. Brown of University of California, Davis, Medical Center said in her invited analysis (J. Thorac. Cardiovasc. Surg. 2016 Mar;151:715-16). Without the authors’ “descriptive approach,” Dr. Brown said, “the results of a true meta-analysis would be uninterpretable.”
Dr. Lisa M. Brown |
Nonetheless, the systematic review underscores the need for a blinded, randomized trial, Dr. Brown said. “Furthermore, rather than measuring [hospital] stay, subjects should be evaluated for readiness for discharge, because this would reduce the effect of systems-based obstacles to discharge,” she said. Enhanced recovery pathways (ERPs) in colorectal surgery have been used as models for other specialties, but the novelty of these pathways versus traditional care may be difficult to replicate in thoracic surgery, she said. Strategies such as antibiotic prophylaxis and epidural analgesia in thoracic surgery “are not dissimilar enough from standard care to elicit a difference in outcome,” she said.
In thoracic surgery, ERPs must consider the challenges of pain control and chest tube management unique in these patients, Dr. Brown said. For pain control, paravertebral blockade rather than epidural analgesia could lead to earlier hospital discharges. Use of chest tubes is commonly a matter of surgeon preference, she said, but chest tubes without an air leak and with acceptable fluid output can be safely removed, and even patients with an air leak but no pneumothorax on water seal can go home with a chest tube, Dr. Brown said.
Dr. Brown had no financial relationships to disclose.
The task that Dr. Fiore and colleagues undertook to evaluate and compare disparate studies of fast-track surgery in lung resection is “akin to comparing not just apples and oranges but apples to zucchini,” Dr. Lisa M. Brown of University of California, Davis, Medical Center said in her invited analysis (J. Thorac. Cardiovasc. Surg. 2016 Mar;151:715-16). Without the authors’ “descriptive approach,” Dr. Brown said, “the results of a true meta-analysis would be uninterpretable.”
Dr. Lisa M. Brown |
Nonetheless, the systematic review underscores the need for a blinded, randomized trial, Dr. Brown said. “Furthermore, rather than measuring [hospital] stay, subjects should be evaluated for readiness for discharge, because this would reduce the effect of systems-based obstacles to discharge,” she said. Enhanced recovery pathways (ERPs) in colorectal surgery have been used as models for other specialties, but the novelty of these pathways versus traditional care may be difficult to replicate in thoracic surgery, she said. Strategies such as antibiotic prophylaxis and epidural analgesia in thoracic surgery “are not dissimilar enough from standard care to elicit a difference in outcome,” she said.
In thoracic surgery, ERPs must consider the challenges of pain control and chest tube management unique in these patients, Dr. Brown said. For pain control, paravertebral blockade rather than epidural analgesia could lead to earlier hospital discharges. Use of chest tubes is commonly a matter of surgeon preference, she said, but chest tubes without an air leak and with acceptable fluid output can be safely removed, and even patients with an air leak but no pneumothorax on water seal can go home with a chest tube, Dr. Brown said.
Dr. Brown had no financial relationships to disclose.
The task that Dr. Fiore and colleagues undertook to evaluate and compare disparate studies of fast-track surgery in lung resection is “akin to comparing not just apples and oranges but apples to zucchini,” Dr. Lisa M. Brown of University of California, Davis, Medical Center said in her invited analysis (J. Thorac. Cardiovasc. Surg. 2016 Mar;151:715-16). Without the authors’ “descriptive approach,” Dr. Brown said, “the results of a true meta-analysis would be uninterpretable.”
Dr. Lisa M. Brown |
Nonetheless, the systematic review underscores the need for a blinded, randomized trial, Dr. Brown said. “Furthermore, rather than measuring [hospital] stay, subjects should be evaluated for readiness for discharge, because this would reduce the effect of systems-based obstacles to discharge,” she said. Enhanced recovery pathways (ERPs) in colorectal surgery have been used as models for other specialties, but the novelty of these pathways versus traditional care may be difficult to replicate in thoracic surgery, she said. Strategies such as antibiotic prophylaxis and epidural analgesia in thoracic surgery “are not dissimilar enough from standard care to elicit a difference in outcome,” she said.
In thoracic surgery, ERPs must consider the challenges of pain control and chest tube management unique in these patients, Dr. Brown said. For pain control, paravertebral blockade rather than epidural analgesia could lead to earlier hospital discharges. Use of chest tubes is commonly a matter of surgeon preference, she said, but chest tubes without an air leak and with acceptable fluid output can be safely removed, and even patients with an air leak but no pneumothorax on water seal can go home with a chest tube, Dr. Brown said.
Dr. Brown had no financial relationships to disclose.
A host of medical specialties have adopted strategies to speed recovery of surgical patients, reduce length of hospital stays, and cut costs, known as fast-track or enhanced-recovery pathways, but when it comes to elective lung resection, the medical evidence has yet to establish if patients in expedited recovery protocols fare any better than do those in a conventional recovery course, a systematic review in the March issue of the Journal of Thoracic and Cardiovascular Surgery reported (2016 Mar;151:708-15).
A team of investigators from McGill University in Montreal performed a systematic review of six studies that evaluated patient outcomes of both traditional and enhanced-recovery pathways (ERPs) in elective lung resection. They concluded that ERPs may reduce the length of hospital stays and hospital costs but that well-designed trials are needed to overcome limitations of existing studies.
“The influence of ERPs on postoperative outcomes after lung resection has not been extensively studied in comparative studies involving a control group receiving traditional care,” lead author Julio F. Fiore Jr., Ph.D., and his colleagues said. One of the six studies they reviewed was a randomized clinical trial. The six studies involved a total of 1,612 participants (821 ERP, 791 control).
The researchers also reported that the studies they analyzed shared a significant limitation. “Risk of bias favoring enhanced-recovery pathways was high,” Dr. Fiore and his colleagues wrote. The studies were unclear if patient selection may have factored into the results.
Five studies reported shorter hospital length of stay (LOS) for the ERP group. “The majority of the studies reported that LOS was significantly shorter when patients undergoing lung resection were treated within an ERP, which corroborates the results observed in other surgical populations,” Dr. Fiore and his colleagues said.
Three nonrandomized studies also evaluated costs per patient. Two reported significantly lower costs for ERP patients: $13,093 vs. $14,439 for controls; and $13,432 vs. $17,103 for controls (Jpn. J. Thorac. Cardiovasc. Surg. 2006 Sep;54:387-90; Ann. Thorac. Surg. 1998 Sep;66:914-9). The third showed what the authors said was no statistically significant cost differential between the two groups: $14,792 for ERP vs. $16,063 for controls (Ann. Thorac. Surg. 1997 Aug;64:299-302).
Three studies evaluated readmission rates, but only one showed measurably lower rates for the ERP group: 3% vs. 10% for controls (Lung Cancer. 2012 Dec;78:270-5). Three studies measured complication rates in both groups. Two reported cardiopulmonary complication rates of 18% and 17% in the ERP group vs. 16% and 14% in the control group, respectively (Eur. J. Cardiothorac. Surg. 2012 May;41:1083-7; Lung Cancer. 2012 Dec;78:270-5). One reported rates of pulmonary complications of 7% for ERP vs. 36% for controls (Eur. J. Cardiothorac. Surg. 2008 Jul;34:174-80).
Dr. Fiore and his colleagues pointed out that some of the studies they reviewed were completed before video-assisted thoracic surgery became routine for lung resection. But they acknowledged that research in other surgical specialties have validated the role of ERP, along with minimally invasive surgery, to improve outcomes. “Future research should investigate whether this holds true for patients undergoing lung resection,” they said.
The study authors had no financial relationships to disclose.
A host of medical specialties have adopted strategies to speed recovery of surgical patients, reduce length of hospital stays, and cut costs, known as fast-track or enhanced-recovery pathways, but when it comes to elective lung resection, the medical evidence has yet to establish if patients in expedited recovery protocols fare any better than do those in a conventional recovery course, a systematic review in the March issue of the Journal of Thoracic and Cardiovascular Surgery reported (2016 Mar;151:708-15).
A team of investigators from McGill University in Montreal performed a systematic review of six studies that evaluated patient outcomes of both traditional and enhanced-recovery pathways (ERPs) in elective lung resection. They concluded that ERPs may reduce the length of hospital stays and hospital costs but that well-designed trials are needed to overcome limitations of existing studies.
“The influence of ERPs on postoperative outcomes after lung resection has not been extensively studied in comparative studies involving a control group receiving traditional care,” lead author Julio F. Fiore Jr., Ph.D., and his colleagues said. One of the six studies they reviewed was a randomized clinical trial. The six studies involved a total of 1,612 participants (821 ERP, 791 control).
The researchers also reported that the studies they analyzed shared a significant limitation. “Risk of bias favoring enhanced-recovery pathways was high,” Dr. Fiore and his colleagues wrote. The studies were unclear if patient selection may have factored into the results.
Five studies reported shorter hospital length of stay (LOS) for the ERP group. “The majority of the studies reported that LOS was significantly shorter when patients undergoing lung resection were treated within an ERP, which corroborates the results observed in other surgical populations,” Dr. Fiore and his colleagues said.
Three nonrandomized studies also evaluated costs per patient. Two reported significantly lower costs for ERP patients: $13,093 vs. $14,439 for controls; and $13,432 vs. $17,103 for controls (Jpn. J. Thorac. Cardiovasc. Surg. 2006 Sep;54:387-90; Ann. Thorac. Surg. 1998 Sep;66:914-9). The third showed what the authors said was no statistically significant cost differential between the two groups: $14,792 for ERP vs. $16,063 for controls (Ann. Thorac. Surg. 1997 Aug;64:299-302).
Three studies evaluated readmission rates, but only one showed measurably lower rates for the ERP group: 3% vs. 10% for controls (Lung Cancer. 2012 Dec;78:270-5). Three studies measured complication rates in both groups. Two reported cardiopulmonary complication rates of 18% and 17% in the ERP group vs. 16% and 14% in the control group, respectively (Eur. J. Cardiothorac. Surg. 2012 May;41:1083-7; Lung Cancer. 2012 Dec;78:270-5). One reported rates of pulmonary complications of 7% for ERP vs. 36% for controls (Eur. J. Cardiothorac. Surg. 2008 Jul;34:174-80).
Dr. Fiore and his colleagues pointed out that some of the studies they reviewed were completed before video-assisted thoracic surgery became routine for lung resection. But they acknowledged that research in other surgical specialties have validated the role of ERP, along with minimally invasive surgery, to improve outcomes. “Future research should investigate whether this holds true for patients undergoing lung resection,” they said.
The study authors had no financial relationships to disclose.
Key clinical point: Well-designed clinical trials are needed to determine the effectiveness of fast-track recovery pathways in lung resection.
Major finding: Fast-track lung resection patients showed no differences in readmissions, overall complication and death rates compared to patients subjected to a traditional recovery course.
Data source: Systematic review of six studies published from 1997 to 2012 that involved 1,612 individuals who had lung resection.
Disclosures: The study authors had no financial relationships to disclose.
Serious complications after cancer surgery linked to worse long-term survival
BOSTON – The operation was a success, but the patient died.
It’s an old chestnut for sure, but there is a painful kernel of truth in it, say investigators who found that patients who undergo complex cancer surgery and have serious complications are at significantly increased risk for death for at least 6 months after surgery, compared with patients who undergo the same procedure with few or no complications.
“Our work has important implications for quality assessment. I think in cancer surgery in particular we have to get away from the short-term metrics of survival, and we have to think about the implications of complications for long-term survival, even if at a very high-quality hospital we’re good at salvaging those patients who do experience those complications,” said Dr. Hari Nathan of the University of Michigan, Ann Arbor.
In a retrospective study, results of which were presented at the annual Society of Surgical Oncology Cancer Symposium, Dr. Nathan and colleagues showed that patients who underwent surgery for cancers of the esophagus and lung who had serious complications but survived at least 30 days after surgery had a more than twofold greater risk for death than did patients who had no complications, and patients with serious complications following surgery for cancer of the pancreas had a nearly twofold greater risk.
The effects of serious complications on survival persisted out to at least 180 days after surgery for each of the three procedures.
The findings suggest that just getting the patient through the operation and keeping him or her alive in the ICU is not sufficient cause for celebration by surgeons, Dr. Nathan said.
The investigators conducted the study to examine the incidence of complications following cancer surgery in older patients, the relationship between surgical complications and long-term survival, and whether the effects of complications would diminish or “wash out” over time. They reviewed Surveillance, Epidemiology and End Results–Medicare data on patients aged 65 years and older who underwent surgery with curative intent for esophageal cancer, non–small cell lung cancer, or pancreatic adenocarcinoma from 2005 through 2009.
They defined serious complications as “the appearance of a complication associated with a hospital length of stay greater than the 75th percentile for that procedure.”
The cohort included 965 patients who underwent esophageal surgery, 12,395 who had lung surgery, and 1,966 who underwent pancreatic resection. The proportion of patients over 80 years who underwent the procedures, respectively, were 12%, 18%, and 19%.
Serious complications occurred in 17% of patients with esophageal cancer, 10% of those with lung cancer, and 12% of those with cancer of the pancreas. The respective 30-day mortality rates were 6.%, 3.3%, and 3.9%.
Looking only at those patients with lung cancer who survived at least 30 days after surgery, the investigators found that median survival among those who had no complications was 79 months, compared with 60 months for those who had mild complications, and 33 months for patients who had serious complications (P less than .001)
“And indeed, when we performed adjusted survival analyses looking at all three disease sites, we saw a very consistent story: that those patients who had serious complications had decreased long-term survival for all three malignancies we looked at,” Dr. Nathan said.
Specifically, in survival analyses adjusted for sex, age, and procedure code, hazard ratios for patients with serious complications compared with those who had no complications were 2.55 for esophageal cancer patients, 2.13 for lung cancer patients, and 1.57 for pancreatic cancer patients (all comparisons significant as shown by 95% confidence intervals).
The investigators questioned whether the differences in mortality were due to the late effects of perioperative complications.
“In modern ICUs, we can keep virtually anybody alive for 30 days, and there has been a lot interest in longer-term metrics for perioperative mortality, for example, at 30 or 90 days, so we thought maybe that’s what we were seeing here,” he said. To test this idea, the investigators looked at the effects of complications on patient who survived lung cancer surgery for at least 90 days, and those who lived for at least 180 days after surgery, and they saw that the survival curves were similar to those seen with the 30-day survivors, showing significantly and persistently worse survival for patients with serious complications (P less than .001).
For each of the disease states, patients with serious complications were also significantly less likely than were those with no or mild complications to receive adjuvant chemotherapy, even after adjustment for patient age and cancer stage, two significant determinants of the likelihood of receiving chemotherapy.
And even when the effect of chemotherapy for those who did receive it was added into the survival models, patients with serious complications still had significantly worse overall survival, Dr. Nathan noted.
“Serious complications after these three cancer resections are common and they are associated with dramatically inferior long-term survival. Thirty, 60, 90, and even 180-day measures of mortality do not capture the full impact of complications on long-term survival,” he said.
Asked whether it may be possible to identify those patients at higher risk for serious complications due to comorbidities or other factors, and perhaps suggest withholding surgery from such patients, Dr. Nathan agreed, but added that “the best chance for survival for all of these patients is a high-quality surgical resection, so it’s hard to deny a patient that chance unless you think they have a really high risk of perioperative death.”
The study was internally funded. Dr. Nathan reported no significant disclosures.
BOSTON – The operation was a success, but the patient died.
It’s an old chestnut for sure, but there is a painful kernel of truth in it, say investigators who found that patients who undergo complex cancer surgery and have serious complications are at significantly increased risk for death for at least 6 months after surgery, compared with patients who undergo the same procedure with few or no complications.
“Our work has important implications for quality assessment. I think in cancer surgery in particular we have to get away from the short-term metrics of survival, and we have to think about the implications of complications for long-term survival, even if at a very high-quality hospital we’re good at salvaging those patients who do experience those complications,” said Dr. Hari Nathan of the University of Michigan, Ann Arbor.
In a retrospective study, results of which were presented at the annual Society of Surgical Oncology Cancer Symposium, Dr. Nathan and colleagues showed that patients who underwent surgery for cancers of the esophagus and lung who had serious complications but survived at least 30 days after surgery had a more than twofold greater risk for death than did patients who had no complications, and patients with serious complications following surgery for cancer of the pancreas had a nearly twofold greater risk.
The effects of serious complications on survival persisted out to at least 180 days after surgery for each of the three procedures.
The findings suggest that just getting the patient through the operation and keeping him or her alive in the ICU is not sufficient cause for celebration by surgeons, Dr. Nathan said.
The investigators conducted the study to examine the incidence of complications following cancer surgery in older patients, the relationship between surgical complications and long-term survival, and whether the effects of complications would diminish or “wash out” over time. They reviewed Surveillance, Epidemiology and End Results–Medicare data on patients aged 65 years and older who underwent surgery with curative intent for esophageal cancer, non–small cell lung cancer, or pancreatic adenocarcinoma from 2005 through 2009.
They defined serious complications as “the appearance of a complication associated with a hospital length of stay greater than the 75th percentile for that procedure.”
The cohort included 965 patients who underwent esophageal surgery, 12,395 who had lung surgery, and 1,966 who underwent pancreatic resection. The proportion of patients over 80 years who underwent the procedures, respectively, were 12%, 18%, and 19%.
Serious complications occurred in 17% of patients with esophageal cancer, 10% of those with lung cancer, and 12% of those with cancer of the pancreas. The respective 30-day mortality rates were 6.%, 3.3%, and 3.9%.
Looking only at those patients with lung cancer who survived at least 30 days after surgery, the investigators found that median survival among those who had no complications was 79 months, compared with 60 months for those who had mild complications, and 33 months for patients who had serious complications (P less than .001)
“And indeed, when we performed adjusted survival analyses looking at all three disease sites, we saw a very consistent story: that those patients who had serious complications had decreased long-term survival for all three malignancies we looked at,” Dr. Nathan said.
Specifically, in survival analyses adjusted for sex, age, and procedure code, hazard ratios for patients with serious complications compared with those who had no complications were 2.55 for esophageal cancer patients, 2.13 for lung cancer patients, and 1.57 for pancreatic cancer patients (all comparisons significant as shown by 95% confidence intervals).
The investigators questioned whether the differences in mortality were due to the late effects of perioperative complications.
“In modern ICUs, we can keep virtually anybody alive for 30 days, and there has been a lot interest in longer-term metrics for perioperative mortality, for example, at 30 or 90 days, so we thought maybe that’s what we were seeing here,” he said. To test this idea, the investigators looked at the effects of complications on patient who survived lung cancer surgery for at least 90 days, and those who lived for at least 180 days after surgery, and they saw that the survival curves were similar to those seen with the 30-day survivors, showing significantly and persistently worse survival for patients with serious complications (P less than .001).
For each of the disease states, patients with serious complications were also significantly less likely than were those with no or mild complications to receive adjuvant chemotherapy, even after adjustment for patient age and cancer stage, two significant determinants of the likelihood of receiving chemotherapy.
And even when the effect of chemotherapy for those who did receive it was added into the survival models, patients with serious complications still had significantly worse overall survival, Dr. Nathan noted.
“Serious complications after these three cancer resections are common and they are associated with dramatically inferior long-term survival. Thirty, 60, 90, and even 180-day measures of mortality do not capture the full impact of complications on long-term survival,” he said.
Asked whether it may be possible to identify those patients at higher risk for serious complications due to comorbidities or other factors, and perhaps suggest withholding surgery from such patients, Dr. Nathan agreed, but added that “the best chance for survival for all of these patients is a high-quality surgical resection, so it’s hard to deny a patient that chance unless you think they have a really high risk of perioperative death.”
The study was internally funded. Dr. Nathan reported no significant disclosures.
BOSTON – The operation was a success, but the patient died.
It’s an old chestnut for sure, but there is a painful kernel of truth in it, say investigators who found that patients who undergo complex cancer surgery and have serious complications are at significantly increased risk for death for at least 6 months after surgery, compared with patients who undergo the same procedure with few or no complications.
“Our work has important implications for quality assessment. I think in cancer surgery in particular we have to get away from the short-term metrics of survival, and we have to think about the implications of complications for long-term survival, even if at a very high-quality hospital we’re good at salvaging those patients who do experience those complications,” said Dr. Hari Nathan of the University of Michigan, Ann Arbor.
In a retrospective study, results of which were presented at the annual Society of Surgical Oncology Cancer Symposium, Dr. Nathan and colleagues showed that patients who underwent surgery for cancers of the esophagus and lung who had serious complications but survived at least 30 days after surgery had a more than twofold greater risk for death than did patients who had no complications, and patients with serious complications following surgery for cancer of the pancreas had a nearly twofold greater risk.
The effects of serious complications on survival persisted out to at least 180 days after surgery for each of the three procedures.
The findings suggest that just getting the patient through the operation and keeping him or her alive in the ICU is not sufficient cause for celebration by surgeons, Dr. Nathan said.
The investigators conducted the study to examine the incidence of complications following cancer surgery in older patients, the relationship between surgical complications and long-term survival, and whether the effects of complications would diminish or “wash out” over time. They reviewed Surveillance, Epidemiology and End Results–Medicare data on patients aged 65 years and older who underwent surgery with curative intent for esophageal cancer, non–small cell lung cancer, or pancreatic adenocarcinoma from 2005 through 2009.
They defined serious complications as “the appearance of a complication associated with a hospital length of stay greater than the 75th percentile for that procedure.”
The cohort included 965 patients who underwent esophageal surgery, 12,395 who had lung surgery, and 1,966 who underwent pancreatic resection. The proportion of patients over 80 years who underwent the procedures, respectively, were 12%, 18%, and 19%.
Serious complications occurred in 17% of patients with esophageal cancer, 10% of those with lung cancer, and 12% of those with cancer of the pancreas. The respective 30-day mortality rates were 6.%, 3.3%, and 3.9%.
Looking only at those patients with lung cancer who survived at least 30 days after surgery, the investigators found that median survival among those who had no complications was 79 months, compared with 60 months for those who had mild complications, and 33 months for patients who had serious complications (P less than .001)
“And indeed, when we performed adjusted survival analyses looking at all three disease sites, we saw a very consistent story: that those patients who had serious complications had decreased long-term survival for all three malignancies we looked at,” Dr. Nathan said.
Specifically, in survival analyses adjusted for sex, age, and procedure code, hazard ratios for patients with serious complications compared with those who had no complications were 2.55 for esophageal cancer patients, 2.13 for lung cancer patients, and 1.57 for pancreatic cancer patients (all comparisons significant as shown by 95% confidence intervals).
The investigators questioned whether the differences in mortality were due to the late effects of perioperative complications.
“In modern ICUs, we can keep virtually anybody alive for 30 days, and there has been a lot interest in longer-term metrics for perioperative mortality, for example, at 30 or 90 days, so we thought maybe that’s what we were seeing here,” he said. To test this idea, the investigators looked at the effects of complications on patient who survived lung cancer surgery for at least 90 days, and those who lived for at least 180 days after surgery, and they saw that the survival curves were similar to those seen with the 30-day survivors, showing significantly and persistently worse survival for patients with serious complications (P less than .001).
For each of the disease states, patients with serious complications were also significantly less likely than were those with no or mild complications to receive adjuvant chemotherapy, even after adjustment for patient age and cancer stage, two significant determinants of the likelihood of receiving chemotherapy.
And even when the effect of chemotherapy for those who did receive it was added into the survival models, patients with serious complications still had significantly worse overall survival, Dr. Nathan noted.
“Serious complications after these three cancer resections are common and they are associated with dramatically inferior long-term survival. Thirty, 60, 90, and even 180-day measures of mortality do not capture the full impact of complications on long-term survival,” he said.
Asked whether it may be possible to identify those patients at higher risk for serious complications due to comorbidities or other factors, and perhaps suggest withholding surgery from such patients, Dr. Nathan agreed, but added that “the best chance for survival for all of these patients is a high-quality surgical resection, so it’s hard to deny a patient that chance unless you think they have a really high risk of perioperative death.”
The study was internally funded. Dr. Nathan reported no significant disclosures.
AT SSO 2016
Key clinical point: Thirty-day postoperative survival may not be an adequate measure of success of complex cancer surgeries.
Major finding: Patients with serious complications from esophageal, lung, and pancreatic cancer operations had significantly worse survival out to 180 days ,compared with those with mild or no complications.
Data source: Retrospective review of SEER-Medicare data from 2005-2009.
Disclosures: The study was internally funded. Dr. Nathan reported no significant disclosures.