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Esophageal perforation severity scoring system reliably stratifies patients
The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.
Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.
The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).
Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).
Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.
Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).
Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.
They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.
They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.
“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.
The authors reported having no disclosures.
A webcast of the AATS Annual Meeting presentation of this paper is available.
Dr. Mara B. Antonoff |
Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.
The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.
Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.
Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).
Dr. Mara B. Antonoff |
Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.
The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.
Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.
Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).
Dr. Mara B. Antonoff |
Schweigert and his colleagues suggest that the Pittsburgh scoring system may identify patients suitable for nonoperative management. The authors retrospectively found less morbidity/mortality and less-frequent operative management among patients in Group 1, and thus, a recommendation was formulated favoring less-invasive management for these individuals.
The additional step of evaluating the success of nonoperative management in each group, either through further analyses of the current study or with future prospective studies is needed in order to make such recommendations.
Further demonstrating the utility of the Pittsburgh esophageal PSS, this study supports the notion that prospective, large-scale studies are in need, and that such scoring systems will be instrumental in standardizing data across centers.
Dr. Mara B. Antonoff is from the department of thoracic and cardiothoracic surgery at the University of Texas MD Anderson Cancer Center, Houston. Her remarks were made as part of an invited commentary on the article (J Thorac Cardiovasc Surg. 2016 Apr;151:1012-3).
The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.
Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.
The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).
Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).
Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.
Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).
Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.
They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.
They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.
“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.
The authors reported having no disclosures.
A webcast of the AATS Annual Meeting presentation of this paper is available.
The Pittsburgh perforation severity score (PSS) can be used to improve decision making in the management of esophageal perforation, findings from a retrospective, multicenter study have shown.
Dr. Michael Schweigert and his colleagues performed a study of 288 patients with esophageal perforation treated at 11 centers between 1990 and 2014, using them as a completely independent population to validate whether the PSS could be used to stratify such patients into discrete subgroups with differential outcomes.
The PSS was analyzed using logistic regression as a continuous variable and stratified into low, intermediate and high score groups, according to their report published in the Journal of Thoracic and Cardiovascular Surgery (2016 Apr;151:1002-11).
Operative management was more frequent than nonoperative management (200 patients, or 69.4% vs. 30.6%), according to Dr. Schweigert of the Städtisches Klinikum Dresden Friedrichstadt, Germany, and his colleagues. Patients with esophageal cancer (34/43; 79%) and stricture (18/23; 78.3%) mainly were treated operatively. The most common type of surgery was primary repair (83 patients), followed by surgical drainage (38 patients).
Perforation-related morbidity was seen in 180 patients (65%), with sepsis (21%) and pneumonia (19%) being most common. Overall in-hospital mortality was 20%, and the median length of stay was 27 days.
Patients with fatal outcomes had a significantly higher median PSS score (11 vs. 1) and the median PSS was significantly higher in operatively managed cases, compared with nonoperative cases (5 vs. 4, P = .0001). The researchers found that the PSS score predicted morbidity well, with an area under the curve (AUC) of 0.77, as well as mortality (AUC = 0.83). However, prediction of the need for operative management was not as good (AUC = 0.65).
Based upon their analysis, the researchers proposed a treatment decision tree in which group I (low PSS patients) should have a focus of nonoperative management. Group 2 patients (medium PSS) with non–contained leak preferably should be managed by surgery.
They found that the high-risk group (PSS greater than 5) had the worst prognosis and highest mortality, with the odds for mortality being 8 times higher than that the intermediate group and 18 times higher than the low-risk group. “Because these patients are most endangered by esophageal perforation, early and aggressive treatment is mandatory to avoid fatal outcomes,” the authors stated.
They found that nonoperative management was not associated with higher mortality or more unfavorable outcome regarding perforation-related morbidity or length of stay, but they pointed out that nonoperative treatment was only successful in 60% of cases, with 36 out of the 88 nonoperative patients eventually undergoing surgery and 8 undergoing esophagectomy. But patients with a high perforation severity score were 3.37 times more likely to have operative management compared to low-scoring patients. “Better selective criteria for nonoperative management are urgently required,” they stated.
“The Pittsburgh PSS is helpful to assess the severity and potential consequences of esophageal injury and stratifies patients into low-, intermediate-, and high-risk groups with differential morbidity and mortality outcomes. Prospective studies are required to analyze the influence of the Pittsburgh scoring system on the treatment of esophageal perforation,” the researchers concluded.
The authors reported having no disclosures.
A webcast of the AATS Annual Meeting presentation of this paper is available.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Scoring system reliably stratifies patients into low-, intermediate-, and high-risk groups.
Major finding: Patients with a high perforation severity score were 3.37 times more likely to have operative management, compared with low-scoring patients.
Data source: A retrospective study was performed on 288 patients with esophageal perforation at 11 centers since 1990.
Disclosures: The authors presented no relevant disclosures.
VIDEO: EVLP may extend lung preservation, quality for transplants
BALTIMORE – The use of ex vivo lung perfusion (EVLP) may allow for the safe transplantation of lungs preserved for more than 12 hours, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.
A research team at the University of Toronto evaluated the outcomes of transplant patients who received a lung with a preservation time of over 12 hours between January 2006 and April 2015 and compared them to the general lung transplant population. Median hospital and ICU length of stay were similar between the two groups, and Kaplan-Meier survival curves between the two groups did not show any difference. Preservation time, donor PO2, and use of EVLP were not significant variables affecting survival.
Dr. Bartley P. Griffith, chief of cardiac surgery at the University of Maryland, Baltimore, and a discussant on the paper at the meeting, said that the findings of the study open up the possibility of a more “planned” approach to transplantation.
“Anything that not only extends preservation time, but perhaps even improves quality of preservation, would be a godsend,” Dr. Griffith said in a video interview. He cautioned that the “devil is in the details,” and that the data had to be examined closely. Nevertheless, Dr. Griffith said transplant surgeons should be grateful for the important work done by the University of Toronto team.
Dr. Griffith 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 – The use of ex vivo lung perfusion (EVLP) may allow for the safe transplantation of lungs preserved for more than 12 hours, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.
A research team at the University of Toronto evaluated the outcomes of transplant patients who received a lung with a preservation time of over 12 hours between January 2006 and April 2015 and compared them to the general lung transplant population. Median hospital and ICU length of stay were similar between the two groups, and Kaplan-Meier survival curves between the two groups did not show any difference. Preservation time, donor PO2, and use of EVLP were not significant variables affecting survival.
Dr. Bartley P. Griffith, chief of cardiac surgery at the University of Maryland, Baltimore, and a discussant on the paper at the meeting, said that the findings of the study open up the possibility of a more “planned” approach to transplantation.
“Anything that not only extends preservation time, but perhaps even improves quality of preservation, would be a godsend,” Dr. Griffith said in a video interview. He cautioned that the “devil is in the details,” and that the data had to be examined closely. Nevertheless, Dr. Griffith said transplant surgeons should be grateful for the important work done by the University of Toronto team.
Dr. Griffith 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 – The use of ex vivo lung perfusion (EVLP) may allow for the safe transplantation of lungs preserved for more than 12 hours, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.
A research team at the University of Toronto evaluated the outcomes of transplant patients who received a lung with a preservation time of over 12 hours between January 2006 and April 2015 and compared them to the general lung transplant population. Median hospital and ICU length of stay were similar between the two groups, and Kaplan-Meier survival curves between the two groups did not show any difference. Preservation time, donor PO2, and use of EVLP were not significant variables affecting survival.
Dr. Bartley P. Griffith, chief of cardiac surgery at the University of Maryland, Baltimore, and a discussant on the paper at the meeting, said that the findings of the study open up the possibility of a more “planned” approach to transplantation.
“Anything that not only extends preservation time, but perhaps even improves quality of preservation, would be a godsend,” Dr. Griffith said in a video interview. He cautioned that the “devil is in the details,” and that the data had to be examined closely. Nevertheless, Dr. Griffith said transplant surgeons should be grateful for the important work done by the University of Toronto team.
Dr. Griffith 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
VIDEO: Identifying patients who will benefit from pulmonary metastasectomy
BALTIMORE – New research from Memorial Sloan Kettering Cancer Center in New York could help surgeons better determine which patients with soft tissue sarcoma may benefit most from pulmonary metastasectomy.
The results of the research, presented at the annual meeting of the American Association for Thoracic Surgery, suggest that preoperative factors such as primary tumor histology and size, number of metastases, time from initial resection of the primary, absence of extrapulmonary disease, and thoracoscopic resection are associated with improved survival in STS patients.
Dr. Garrett L. Walsh, professor of surgery at the University of Texas MD Anderson Cancer Center, Houston, and a discussant on the paper at the meeting, said the study was important because it showed the power of a prospective surgical database, retrospectively viewed in this particular case. He said that the Sloan Kettering research was likely “as good as it’s going to get,” given that a randomized controlled trial is unlikely ever to occur with STS patients.
“Trying to select the patients we think are going to do well with surgery has always been one of the challenging aspects of thoracic surgery,” Dr. Walsh said in a video interview. “This paper may help with better selection of patients from that large cohort who are referred to us for pulmonary metastasectomy.”
Dr. Walsh 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 – New research from Memorial Sloan Kettering Cancer Center in New York could help surgeons better determine which patients with soft tissue sarcoma may benefit most from pulmonary metastasectomy.
The results of the research, presented at the annual meeting of the American Association for Thoracic Surgery, suggest that preoperative factors such as primary tumor histology and size, number of metastases, time from initial resection of the primary, absence of extrapulmonary disease, and thoracoscopic resection are associated with improved survival in STS patients.
Dr. Garrett L. Walsh, professor of surgery at the University of Texas MD Anderson Cancer Center, Houston, and a discussant on the paper at the meeting, said the study was important because it showed the power of a prospective surgical database, retrospectively viewed in this particular case. He said that the Sloan Kettering research was likely “as good as it’s going to get,” given that a randomized controlled trial is unlikely ever to occur with STS patients.
“Trying to select the patients we think are going to do well with surgery has always been one of the challenging aspects of thoracic surgery,” Dr. Walsh said in a video interview. “This paper may help with better selection of patients from that large cohort who are referred to us for pulmonary metastasectomy.”
Dr. Walsh 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 – New research from Memorial Sloan Kettering Cancer Center in New York could help surgeons better determine which patients with soft tissue sarcoma may benefit most from pulmonary metastasectomy.
The results of the research, presented at the annual meeting of the American Association for Thoracic Surgery, suggest that preoperative factors such as primary tumor histology and size, number of metastases, time from initial resection of the primary, absence of extrapulmonary disease, and thoracoscopic resection are associated with improved survival in STS patients.
Dr. Garrett L. Walsh, professor of surgery at the University of Texas MD Anderson Cancer Center, Houston, and a discussant on the paper at the meeting, said the study was important because it showed the power of a prospective surgical database, retrospectively viewed in this particular case. He said that the Sloan Kettering research was likely “as good as it’s going to get,” given that a randomized controlled trial is unlikely ever to occur with STS patients.
“Trying to select the patients we think are going to do well with surgery has always been one of the challenging aspects of thoracic surgery,” Dr. Walsh said in a video interview. “This paper may help with better selection of patients from that large cohort who are referred to us for pulmonary metastasectomy.”
Dr. Walsh 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
VIDEO: Two good options for mitral valve repair
BALTIMORE – Degenerative mitral regurgitation due to anterior or bileaflet prolapse can be treated with excellent results by both the traditional double orifice edge-to-edge repair or the implantation of artificial chordae, combined with ring annuloplasty, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.
Researchers at San Raffaele University Hospital in Milan undertook a long-term comparison between the two methods of degenerative MR repair and found no differences in outcomes in cases of bileaflet prolapse, whereas in isolated anterior leaflet prolapse, the double orifice repair actually appeared to be more effective.
Mitral valve repair is a very well-accepted modality to fix posterior leaflet prolapse, according to Dr. Marc Ruel, chief of cardiac surgery at the University of Ottawa Heart Institute and a discussant on the paper at the meeting. But anterior mitral leaflet prolapse is a much more challenging operation, he said, and surgeons are looking for a “foolproof” way to address it.
“The double orifice repair, for most surgeons, is a much simpler procedure than doing artificial chordae, so this is good news,” Dr. Ruel said. “It shows that a fairly reproducible way of repairing the mitral valve seems to work as well, and likely better in some lesions, than the more complex way of addressing it.”
Dr. Ruel, who discusses the study in this video interview, 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 – Degenerative mitral regurgitation due to anterior or bileaflet prolapse can be treated with excellent results by both the traditional double orifice edge-to-edge repair or the implantation of artificial chordae, combined with ring annuloplasty, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.
Researchers at San Raffaele University Hospital in Milan undertook a long-term comparison between the two methods of degenerative MR repair and found no differences in outcomes in cases of bileaflet prolapse, whereas in isolated anterior leaflet prolapse, the double orifice repair actually appeared to be more effective.
Mitral valve repair is a very well-accepted modality to fix posterior leaflet prolapse, according to Dr. Marc Ruel, chief of cardiac surgery at the University of Ottawa Heart Institute and a discussant on the paper at the meeting. But anterior mitral leaflet prolapse is a much more challenging operation, he said, and surgeons are looking for a “foolproof” way to address it.
“The double orifice repair, for most surgeons, is a much simpler procedure than doing artificial chordae, so this is good news,” Dr. Ruel said. “It shows that a fairly reproducible way of repairing the mitral valve seems to work as well, and likely better in some lesions, than the more complex way of addressing it.”
Dr. Ruel, who discusses the study in this video interview, 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 – Degenerative mitral regurgitation due to anterior or bileaflet prolapse can be treated with excellent results by both the traditional double orifice edge-to-edge repair or the implantation of artificial chordae, combined with ring annuloplasty, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.
Researchers at San Raffaele University Hospital in Milan undertook a long-term comparison between the two methods of degenerative MR repair and found no differences in outcomes in cases of bileaflet prolapse, whereas in isolated anterior leaflet prolapse, the double orifice repair actually appeared to be more effective.
Mitral valve repair is a very well-accepted modality to fix posterior leaflet prolapse, according to Dr. Marc Ruel, chief of cardiac surgery at the University of Ottawa Heart Institute and a discussant on the paper at the meeting. But anterior mitral leaflet prolapse is a much more challenging operation, he said, and surgeons are looking for a “foolproof” way to address it.
“The double orifice repair, for most surgeons, is a much simpler procedure than doing artificial chordae, so this is good news,” Dr. Ruel said. “It shows that a fairly reproducible way of repairing the mitral valve seems to work as well, and likely better in some lesions, than the more complex way of addressing it.”
Dr. Ruel, who discusses the study in this video interview, 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.
VIDEO: Stenting to improve quality of life in esophageal cancer
PHILADELPHIA – An esophageal stent can improve quality of life for patients with advanced esophageal cancer, according to Dr. Sushil Ahlawat, director of endoscopy at Rutgers University, New Brunswick, N.J.
“An esophageal stent can be an important modality for palliating patients’ dysphagia, [which] can happen because the tumor is obstructing the esophagus,” says Dr. Ahlawat in this video. He also discusses how this minimally invasive procedure can support those undergoing chemoradiation therapy or surgery for esophageal cancer.
The video was recorded at this year’s meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy for Medical Education and this news organization are owned by the same company.
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 @whitneymcknight
PHILADELPHIA – An esophageal stent can improve quality of life for patients with advanced esophageal cancer, according to Dr. Sushil Ahlawat, director of endoscopy at Rutgers University, New Brunswick, N.J.
“An esophageal stent can be an important modality for palliating patients’ dysphagia, [which] can happen because the tumor is obstructing the esophagus,” says Dr. Ahlawat in this video. He also discusses how this minimally invasive procedure can support those undergoing chemoradiation therapy or surgery for esophageal cancer.
The video was recorded at this year’s meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy for Medical Education and this news organization are owned by the same company.
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 @whitneymcknight
PHILADELPHIA – An esophageal stent can improve quality of life for patients with advanced esophageal cancer, according to Dr. Sushil Ahlawat, director of endoscopy at Rutgers University, New Brunswick, N.J.
“An esophageal stent can be an important modality for palliating patients’ dysphagia, [which] can happen because the tumor is obstructing the esophagus,” says Dr. Ahlawat in this video. He also discusses how this minimally invasive procedure can support those undergoing chemoradiation therapy or surgery for esophageal cancer.
The video was recorded at this year’s meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy for Medical Education and this news organization are owned by the same company.
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 @whitneymcknight
EXPERT ANALYSIS FROM DIGESTIVE DISEASES: NEW ADVANCES
VIDEO: Eight new quality measures key to performance of esophageal manometry
Health care providers performing esophageal manometry should keep in mind eight new quality measures listed and validated in a recent study published in the April issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. 2015 Oct 20. doi: 10.1016/j.cgh.2015.10.006), which researchers believe will significantly improve the performance of esophageal manometry and interpretation of data culled from such procedures.
“Despite its critical importance in the diagnosis and management of esophageal motility disorders, features of a high-quality esophageal manometry [study] have not been formally defined,” said the study authors, led by Dr. Rena Yadlapati of Northwestern University in Chicago. “Standardizing key aspects of esophageal manometry is imperative to ensure the delivery of high-quality care.”
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Dr. Yadlapati and her coinvestigators carried out the study in accordance with guidelines set out by the RAND/UCLA Appropriateness Method (RAM), They began by recruiting a panel of 15 esophageal manometry experts with leadership, geographical diversity, and a wide range of practice settings being the key criteria in their selection.
Investigators then conducted a literature review, selecting the 30 most relevant randomized, controlled trials, retrospective studies, and systematic reviews from the past 10 years. From this review, investigators created a list of 30 possible quality measures, all of which were then sent to each member of the expert panel via email for them to rank on a 9-point interval scale, and modify if necessary.
Those rankings were then used to determine the appropriateness of each proposed quality measure at a face-to-face meeting among the investigators and the 15-member expert panel, at which 17 quality measures were determined to be appropriate. In all, 2 measures dealt with competency, 2 pertained to assessment before procedure, 3 were regarding performance of the procedure itself, and 10 were about interpretation of data obtained from esophageal manometry; the 10 measures concerning interpretation of data were compiled into 1 measure, leaving a total of 8 that were ultimately approved.
The quality measures for competency are as follows:
• “If esophageal manometry is performed, then the technician must be competent to perform esophageal manometry.”
• “If a physician is considered competent to interpret esophageal manometry, then the physician must interpret a minimum number of esophageal manometry studies annually.”
For assessment before procedure, the measures state the following:
• “If a patient is referred for esophageal manometry, then the patient should have undergone an evaluation for structural abnormalities before manometry.”
• “If an esophageal manometry is performed, then informed consent must be obtained and documented.”
Quality measures regarding the procedure itself state the following:
• “If an esophageal manometry study is performed, then a time interval of at least 30 seconds should occur between swallows.”
• “If an esophageal manometry study is performed, then at least 10 wet swallows should be attempted.”
• “If an esophageal manometry study is performed, then at least seven evaluable wet swallows should be included.”
Finally, regarding interpretation of data, the single quality measures states that “If an esophageal manometry study is interpreted, then a complete procedure report should document the following:
• “Reason for referral.”
• “Clinical diagnosis.”
• “Diagnosis according to formally validated classification scheme.”
• “Documentation of formally validated classification scheme used.”
• “Summary of results”
• “Tabulated results including upper esophageal sphincter activity, interpretation of esophagogastric junction relaxation, documentation of pressure inversion point if technically feasible, pressurization pattern and contractile pattern.”
• “Technical limitation (if applicable).”
• “Communication to referring provider.”
“These eight appropriate quality measures are considered absolutely necessary in the performance and interpretation of esophageal manometry,” the authors concluded. “In particular, measures 3-8 are clinically feasible and measurable, and should serve as an initial framework to benchmark quality and reduce variability in esophageal manometry practices.”
This study was funded by the Alumnae of Northwestern University, and a grant to Dr. Yadlapati (T32 DK101363-02). Five coinvestigators disclosed consultancy and speaking relationships with Boston Scientific, Cook Endoscopy, EndoStim, Given Imaging, Covidien, and Sandhill Scientific.
Health care providers performing esophageal manometry should keep in mind eight new quality measures listed and validated in a recent study published in the April issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. 2015 Oct 20. doi: 10.1016/j.cgh.2015.10.006), which researchers believe will significantly improve the performance of esophageal manometry and interpretation of data culled from such procedures.
“Despite its critical importance in the diagnosis and management of esophageal motility disorders, features of a high-quality esophageal manometry [study] have not been formally defined,” said the study authors, led by Dr. Rena Yadlapati of Northwestern University in Chicago. “Standardizing key aspects of esophageal manometry is imperative to ensure the delivery of high-quality care.”
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Dr. Yadlapati and her coinvestigators carried out the study in accordance with guidelines set out by the RAND/UCLA Appropriateness Method (RAM), They began by recruiting a panel of 15 esophageal manometry experts with leadership, geographical diversity, and a wide range of practice settings being the key criteria in their selection.
Investigators then conducted a literature review, selecting the 30 most relevant randomized, controlled trials, retrospective studies, and systematic reviews from the past 10 years. From this review, investigators created a list of 30 possible quality measures, all of which were then sent to each member of the expert panel via email for them to rank on a 9-point interval scale, and modify if necessary.
Those rankings were then used to determine the appropriateness of each proposed quality measure at a face-to-face meeting among the investigators and the 15-member expert panel, at which 17 quality measures were determined to be appropriate. In all, 2 measures dealt with competency, 2 pertained to assessment before procedure, 3 were regarding performance of the procedure itself, and 10 were about interpretation of data obtained from esophageal manometry; the 10 measures concerning interpretation of data were compiled into 1 measure, leaving a total of 8 that were ultimately approved.
The quality measures for competency are as follows:
• “If esophageal manometry is performed, then the technician must be competent to perform esophageal manometry.”
• “If a physician is considered competent to interpret esophageal manometry, then the physician must interpret a minimum number of esophageal manometry studies annually.”
For assessment before procedure, the measures state the following:
• “If a patient is referred for esophageal manometry, then the patient should have undergone an evaluation for structural abnormalities before manometry.”
• “If an esophageal manometry is performed, then informed consent must be obtained and documented.”
Quality measures regarding the procedure itself state the following:
• “If an esophageal manometry study is performed, then a time interval of at least 30 seconds should occur between swallows.”
• “If an esophageal manometry study is performed, then at least 10 wet swallows should be attempted.”
• “If an esophageal manometry study is performed, then at least seven evaluable wet swallows should be included.”
Finally, regarding interpretation of data, the single quality measures states that “If an esophageal manometry study is interpreted, then a complete procedure report should document the following:
• “Reason for referral.”
• “Clinical diagnosis.”
• “Diagnosis according to formally validated classification scheme.”
• “Documentation of formally validated classification scheme used.”
• “Summary of results”
• “Tabulated results including upper esophageal sphincter activity, interpretation of esophagogastric junction relaxation, documentation of pressure inversion point if technically feasible, pressurization pattern and contractile pattern.”
• “Technical limitation (if applicable).”
• “Communication to referring provider.”
“These eight appropriate quality measures are considered absolutely necessary in the performance and interpretation of esophageal manometry,” the authors concluded. “In particular, measures 3-8 are clinically feasible and measurable, and should serve as an initial framework to benchmark quality and reduce variability in esophageal manometry practices.”
This study was funded by the Alumnae of Northwestern University, and a grant to Dr. Yadlapati (T32 DK101363-02). Five coinvestigators disclosed consultancy and speaking relationships with Boston Scientific, Cook Endoscopy, EndoStim, Given Imaging, Covidien, and Sandhill Scientific.
Health care providers performing esophageal manometry should keep in mind eight new quality measures listed and validated in a recent study published in the April issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. 2015 Oct 20. doi: 10.1016/j.cgh.2015.10.006), which researchers believe will significantly improve the performance of esophageal manometry and interpretation of data culled from such procedures.
“Despite its critical importance in the diagnosis and management of esophageal motility disorders, features of a high-quality esophageal manometry [study] have not been formally defined,” said the study authors, led by Dr. Rena Yadlapati of Northwestern University in Chicago. “Standardizing key aspects of esophageal manometry is imperative to ensure the delivery of high-quality care.”
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Dr. Yadlapati and her coinvestigators carried out the study in accordance with guidelines set out by the RAND/UCLA Appropriateness Method (RAM), They began by recruiting a panel of 15 esophageal manometry experts with leadership, geographical diversity, and a wide range of practice settings being the key criteria in their selection.
Investigators then conducted a literature review, selecting the 30 most relevant randomized, controlled trials, retrospective studies, and systematic reviews from the past 10 years. From this review, investigators created a list of 30 possible quality measures, all of which were then sent to each member of the expert panel via email for them to rank on a 9-point interval scale, and modify if necessary.
Those rankings were then used to determine the appropriateness of each proposed quality measure at a face-to-face meeting among the investigators and the 15-member expert panel, at which 17 quality measures were determined to be appropriate. In all, 2 measures dealt with competency, 2 pertained to assessment before procedure, 3 were regarding performance of the procedure itself, and 10 were about interpretation of data obtained from esophageal manometry; the 10 measures concerning interpretation of data were compiled into 1 measure, leaving a total of 8 that were ultimately approved.
The quality measures for competency are as follows:
• “If esophageal manometry is performed, then the technician must be competent to perform esophageal manometry.”
• “If a physician is considered competent to interpret esophageal manometry, then the physician must interpret a minimum number of esophageal manometry studies annually.”
For assessment before procedure, the measures state the following:
• “If a patient is referred for esophageal manometry, then the patient should have undergone an evaluation for structural abnormalities before manometry.”
• “If an esophageal manometry is performed, then informed consent must be obtained and documented.”
Quality measures regarding the procedure itself state the following:
• “If an esophageal manometry study is performed, then a time interval of at least 30 seconds should occur between swallows.”
• “If an esophageal manometry study is performed, then at least 10 wet swallows should be attempted.”
• “If an esophageal manometry study is performed, then at least seven evaluable wet swallows should be included.”
Finally, regarding interpretation of data, the single quality measures states that “If an esophageal manometry study is interpreted, then a complete procedure report should document the following:
• “Reason for referral.”
• “Clinical diagnosis.”
• “Diagnosis according to formally validated classification scheme.”
• “Documentation of formally validated classification scheme used.”
• “Summary of results”
• “Tabulated results including upper esophageal sphincter activity, interpretation of esophagogastric junction relaxation, documentation of pressure inversion point if technically feasible, pressurization pattern and contractile pattern.”
• “Technical limitation (if applicable).”
• “Communication to referring provider.”
“These eight appropriate quality measures are considered absolutely necessary in the performance and interpretation of esophageal manometry,” the authors concluded. “In particular, measures 3-8 are clinically feasible and measurable, and should serve as an initial framework to benchmark quality and reduce variability in esophageal manometry practices.”
This study was funded by the Alumnae of Northwestern University, and a grant to Dr. Yadlapati (T32 DK101363-02). Five coinvestigators disclosed consultancy and speaking relationships with Boston Scientific, Cook Endoscopy, EndoStim, Given Imaging, Covidien, and Sandhill Scientific.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Health care providers should consider eight new validated quality measures when performing and interpreting esophageal manometry data.
Major finding: Of 30 possible measures, 10 regarding interpretation of data were compiled into a single quality measure, 2 were classified as competency measures, 2 were classified as assessments necessary prior to an esophageal manometry procedure, and 3 were classified as integral to the procedure of esophageal manometry, for a total of 8.
Data source: Survey of existing literature and expert interviews on validated quality measures on the basis of the RAM.
Disclosures: Study was partly funded by a grant from the Alumnae of Northwestern University; five coauthors reported financial disclosures.
FDA proposes ban on powdered gloves
The Food and Drug Administration has proposed a ban on most powdered gloves used during surgery and for patient examination, and on absorbable powder used for lubricating surgeons’ gloves.
Aerosolized glove powder on natural rubber latex gloves can cause respiratory allergic reactions, and while powdered synthetic gloves don’t present the risk of allergic reactions, all powdered gloves have been associated with numerous potentially serious adverse events, including severe airway inflammation, wound inflammation, and postsurgical adhesions, according to an FDA statement.
The proposed ban would not apply to powdered radiographic protection gloves; the agency is not aware of any such gloves that are currently on the market. The ban also would not affect non-powdered gloves.
The decision to move forward with the proposed ban was based on a determination that the affected products “are dangerous and present an unreasonable and substantial risk,” according to the statement.
In making this determination, the FDA considered the available evidence, including a literature review and the 285 comments received on a February 2011 Federal Register Notice.
That notice announced the establishment of a public docket to receive comments related to powdered gloves and followed the FDA’s receipt of two citizen petitions requesting a ban on such gloves because of the adverse health effects associated with use of the gloves. The comments overwhelmingly supported a warning or ban.
The FDA determined that the risks associated with powdered gloves cannot be corrected through new or updated labeling, and thus moved forward with the proposed ban.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health said in the statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
In fact, should this ban be put into place, it would be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit. The benefits cited for powdered gloves were almost entirely related to greater ease of putting the gloves on and taking them off, Eric Pahon of the FDA said in an interview.
A ban on the gloves was not proposed sooner in part because when concerns were first raised about the risks associated with powdered gloves, a ban would have created a shortage, and the risks of a glove shortage outweighed the benefits of banning the gloves, Mr. Pahon said.
However, a recent economic analysis conducted by the FDA because of the critical role medical gloves play in protecting patients and health care providers showed that a powdered glove ban would not cause a glove shortage or have a significant economic impact, and that a ban would not be likely to affect medical practice since numerous non-powdered gloves options are now available, the agency noted.
The proposed rule will be available online March 22 at the Federal Register, and is open for public comment for 90 days.
If finalized, the powdered gloves and absorbable powder used for lubricating surgeons’ gloves would be removed from the marketplace.
The Food and Drug Administration has proposed a ban on most powdered gloves used during surgery and for patient examination, and on absorbable powder used for lubricating surgeons’ gloves.
Aerosolized glove powder on natural rubber latex gloves can cause respiratory allergic reactions, and while powdered synthetic gloves don’t present the risk of allergic reactions, all powdered gloves have been associated with numerous potentially serious adverse events, including severe airway inflammation, wound inflammation, and postsurgical adhesions, according to an FDA statement.
The proposed ban would not apply to powdered radiographic protection gloves; the agency is not aware of any such gloves that are currently on the market. The ban also would not affect non-powdered gloves.
The decision to move forward with the proposed ban was based on a determination that the affected products “are dangerous and present an unreasonable and substantial risk,” according to the statement.
In making this determination, the FDA considered the available evidence, including a literature review and the 285 comments received on a February 2011 Federal Register Notice.
That notice announced the establishment of a public docket to receive comments related to powdered gloves and followed the FDA’s receipt of two citizen petitions requesting a ban on such gloves because of the adverse health effects associated with use of the gloves. The comments overwhelmingly supported a warning or ban.
The FDA determined that the risks associated with powdered gloves cannot be corrected through new or updated labeling, and thus moved forward with the proposed ban.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health said in the statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
In fact, should this ban be put into place, it would be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit. The benefits cited for powdered gloves were almost entirely related to greater ease of putting the gloves on and taking them off, Eric Pahon of the FDA said in an interview.
A ban on the gloves was not proposed sooner in part because when concerns were first raised about the risks associated with powdered gloves, a ban would have created a shortage, and the risks of a glove shortage outweighed the benefits of banning the gloves, Mr. Pahon said.
However, a recent economic analysis conducted by the FDA because of the critical role medical gloves play in protecting patients and health care providers showed that a powdered glove ban would not cause a glove shortage or have a significant economic impact, and that a ban would not be likely to affect medical practice since numerous non-powdered gloves options are now available, the agency noted.
The proposed rule will be available online March 22 at the Federal Register, and is open for public comment for 90 days.
If finalized, the powdered gloves and absorbable powder used for lubricating surgeons’ gloves would be removed from the marketplace.
The Food and Drug Administration has proposed a ban on most powdered gloves used during surgery and for patient examination, and on absorbable powder used for lubricating surgeons’ gloves.
Aerosolized glove powder on natural rubber latex gloves can cause respiratory allergic reactions, and while powdered synthetic gloves don’t present the risk of allergic reactions, all powdered gloves have been associated with numerous potentially serious adverse events, including severe airway inflammation, wound inflammation, and postsurgical adhesions, according to an FDA statement.
The proposed ban would not apply to powdered radiographic protection gloves; the agency is not aware of any such gloves that are currently on the market. The ban also would not affect non-powdered gloves.
The decision to move forward with the proposed ban was based on a determination that the affected products “are dangerous and present an unreasonable and substantial risk,” according to the statement.
In making this determination, the FDA considered the available evidence, including a literature review and the 285 comments received on a February 2011 Federal Register Notice.
That notice announced the establishment of a public docket to receive comments related to powdered gloves and followed the FDA’s receipt of two citizen petitions requesting a ban on such gloves because of the adverse health effects associated with use of the gloves. The comments overwhelmingly supported a warning or ban.
The FDA determined that the risks associated with powdered gloves cannot be corrected through new or updated labeling, and thus moved forward with the proposed ban.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health said in the statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
In fact, should this ban be put into place, it would be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit. The benefits cited for powdered gloves were almost entirely related to greater ease of putting the gloves on and taking them off, Eric Pahon of the FDA said in an interview.
A ban on the gloves was not proposed sooner in part because when concerns were first raised about the risks associated with powdered gloves, a ban would have created a shortage, and the risks of a glove shortage outweighed the benefits of banning the gloves, Mr. Pahon said.
However, a recent economic analysis conducted by the FDA because of the critical role medical gloves play in protecting patients and health care providers showed that a powdered glove ban would not cause a glove shortage or have a significant economic impact, and that a ban would not be likely to affect medical practice since numerous non-powdered gloves options are now available, the agency noted.
The proposed rule will be available online March 22 at the Federal Register, and is open for public comment for 90 days.
If finalized, the powdered gloves and absorbable powder used for lubricating surgeons’ gloves would be removed from the marketplace.
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.
Sutureless AVR an option for higher-risk patients
The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).
The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.
The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.
In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.
Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.
The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.
The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”
They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.
Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.
One of the key advantages that advocates of sutureless valves point to is shorter bypass times than sutured valves, but in his invited commentary Dr. Thomas G. Gleason of the University of Pittsburgh questioned this rationale based on the results Dr. de Varennes and colleagues reported (J. Thorac. Cardiovasc. Surg. 2016;151:743-744). The cardiac bypass times they observed “are not appreciably different from those reported in larger series of conventional aortic valve replacement,” Dr. Gleason said.
Dr. Gleason suggested that “market forces” might be driving the push into sutureless aortic valve replacement. “The attraction, particularly to consumers, of the ministernotomy (and thus things that might facilitate it) is both cosmetic and the perception that it is less invasive,” he said. “These attractions notwithstanding, it has been difficult to demonstrate that ministernotomy or minithoracotomy yield better primary outcomes (e.g., mortality, stroke, or major complication rates) or even quality of life indicators, particularly when measured beyond the perioperative period.”
Dr. Thomas G. Gleason |
He alluded to the “elephant in the room” with regard to sutureless aortic valve technologies: their cost and unknown durability compared with conventional sutured bioprostheses.
“As health care costs continue to rise and large populations of patients are either underinsured or see rationed care, trimming direct costs may be a more relevant concern for the modern era than trimming cross-clamp time,” he said. Analyses have not yet evaluated the increased costs of sutureless valves in terms of shortened hospital stays or lower morbidity, particularly in the moderate-risk population with aortic stenosis, he said.
“Moving forward, there is little doubt that the current value of the sutureless valve will be dictated by the market, but in the end it will be measured by the long-term outcomes of the ‘minimally invaded,’” Dr. Gleason said.
Dr. Gleason had no financial relationships to disclose.
One of the key advantages that advocates of sutureless valves point to is shorter bypass times than sutured valves, but in his invited commentary Dr. Thomas G. Gleason of the University of Pittsburgh questioned this rationale based on the results Dr. de Varennes and colleagues reported (J. Thorac. Cardiovasc. Surg. 2016;151:743-744). The cardiac bypass times they observed “are not appreciably different from those reported in larger series of conventional aortic valve replacement,” Dr. Gleason said.
Dr. Gleason suggested that “market forces” might be driving the push into sutureless aortic valve replacement. “The attraction, particularly to consumers, of the ministernotomy (and thus things that might facilitate it) is both cosmetic and the perception that it is less invasive,” he said. “These attractions notwithstanding, it has been difficult to demonstrate that ministernotomy or minithoracotomy yield better primary outcomes (e.g., mortality, stroke, or major complication rates) or even quality of life indicators, particularly when measured beyond the perioperative period.”
Dr. Thomas G. Gleason |
He alluded to the “elephant in the room” with regard to sutureless aortic valve technologies: their cost and unknown durability compared with conventional sutured bioprostheses.
“As health care costs continue to rise and large populations of patients are either underinsured or see rationed care, trimming direct costs may be a more relevant concern for the modern era than trimming cross-clamp time,” he said. Analyses have not yet evaluated the increased costs of sutureless valves in terms of shortened hospital stays or lower morbidity, particularly in the moderate-risk population with aortic stenosis, he said.
“Moving forward, there is little doubt that the current value of the sutureless valve will be dictated by the market, but in the end it will be measured by the long-term outcomes of the ‘minimally invaded,’” Dr. Gleason said.
Dr. Gleason had no financial relationships to disclose.
One of the key advantages that advocates of sutureless valves point to is shorter bypass times than sutured valves, but in his invited commentary Dr. Thomas G. Gleason of the University of Pittsburgh questioned this rationale based on the results Dr. de Varennes and colleagues reported (J. Thorac. Cardiovasc. Surg. 2016;151:743-744). The cardiac bypass times they observed “are not appreciably different from those reported in larger series of conventional aortic valve replacement,” Dr. Gleason said.
Dr. Gleason suggested that “market forces” might be driving the push into sutureless aortic valve replacement. “The attraction, particularly to consumers, of the ministernotomy (and thus things that might facilitate it) is both cosmetic and the perception that it is less invasive,” he said. “These attractions notwithstanding, it has been difficult to demonstrate that ministernotomy or minithoracotomy yield better primary outcomes (e.g., mortality, stroke, or major complication rates) or even quality of life indicators, particularly when measured beyond the perioperative period.”
Dr. Thomas G. Gleason |
He alluded to the “elephant in the room” with regard to sutureless aortic valve technologies: their cost and unknown durability compared with conventional sutured bioprostheses.
“As health care costs continue to rise and large populations of patients are either underinsured or see rationed care, trimming direct costs may be a more relevant concern for the modern era than trimming cross-clamp time,” he said. Analyses have not yet evaluated the increased costs of sutureless valves in terms of shortened hospital stays or lower morbidity, particularly in the moderate-risk population with aortic stenosis, he said.
“Moving forward, there is little doubt that the current value of the sutureless valve will be dictated by the market, but in the end it will be measured by the long-term outcomes of the ‘minimally invaded,’” Dr. Gleason said.
Dr. Gleason had no financial relationships to disclose.
The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).
The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.
The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.
In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.
Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.
The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.
The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”
They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.
Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.
The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).
The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.
The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.
In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.
Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.
The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.
The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”
They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.
Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Sutureless aortic valves have the potential to achieve shorter procedure times and benefit increased-risk patients with aortic stenosis.
Major finding: Thirty-day mortality of patients who received the Enable aortic valve was 1.6%, and late mortality was 3.2%. No deaths were valve related.
Data source: Sixty-three patients with aortic stenosis who had Enable bioprosthetic valve implantation between August 2012 and October 2014 at McGill University Health Center.
Disclosures: Lead author Dr. Benoit de Varennes is a consultant for Medtronic and a trainer for the Enable device. The other authors had no relationships to disclose.