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Official Newspaper of the American College of Surgeons
Opt for redo root surgery, not TAVI, in young patients
CHICAGO – Whether to perform transcatheter aortic valve implantation in a 57-year-old patient with a severely calcified aortic homograft was the subject of a case report presented at Heart Valve Summit 2012.
"In our center, even though we do a huge number of TAVIs [transcatheter aortic valve implantations], we still believe TAVI should be left for the older patients and those with a restricted life expectancy, because the long-term results are not known," said Dr. Michael Borger, assistant director of the Leipzig (Germany) Heart Center.
The patient in this case was a 57 year-old woman who presented with increased shortness of breath and was found to have NYHA II-III heart failure. At age 40, she had received a homograft aortic root replacement for destructive endocarditis.
Her ejection fraction and left ventricular dimensions were preserved, her AV gradient was 86/52 mm Hg, and her effective orifice area (EOA) was 0.6 cm2. She had no other risk factors and was taking no medications. A coronary angiogram showed a severely calcified homograft and isolated proximal stenosis of the right coronary artery.
Dr. Borger discussed two options: redo root replacement surgery with a bypass to the right coronary artery or a transcatheter aortic valve replacement (TAVR) with a PCI to the right coronary artery.
The decision was to perform conventional surgery. "The patient underwent a redo Bentall operation with a mechanical valve, as well as a RIMA (right internal mammary artery) to RCA (right coronary artery) bypass. She did very well postoperatively without any complications," he said.
Aortic root replacements with aortic homografts are not without risk, and the literature shows relatively high mortality for homograft reoperations. Reoperation after stentless AVR also has been performed, but it often requires replacement of the aortic root and is associated with increased mortality (Ann. Thorac. Surg. 2007;84:737-43).
"Most of those [stentless] operations are difficult because of the inability to get a good plane of cleavage between the stentless valve and the native aortic root," said Dr. Borger. "The large majority of those patients end up leaving the OR with a full root replacement."
Dr. Borger’s fellow panelist, Dr. Michael Reardon, agreed. "I was a real fan of the Toronto SPV valve, and ... I’ve taken a couple out," said Dr. Reardon, professor and vice chair of the Methodist DeBakey Heart and Vascular Center in Houston. "They all end up in root replacements. By the time you’re finished you end up having these shards of tissue ... and porcine tissue incites a huge dermoplastic reaction. ... I personally found it very difficult."
Dr. Borger noted, "In Leipzig we have put in a large number of Toronto roots and, knock on wood, have not reoperated on one of them yet. However, they have not yet reached the period whereby you expect to observe structural valve dysfunction."
A study of valve-related events after aortic root replacement with cryopreserved aortic homografts examined risk after placement of a homograft and found that a heavily calcified homograft at the time of reoperation was a significant predictor of death (Ann. Thorac. Surg. 2005;79:1491-5).
"I’m not saying that TAVI is not an option for all young patients," said Dr. Borger. "If you’ve got a young patient who is at very high risk for conventional surgery with lots of comorbidities, whose life expectancy is 5 years or less, then sure, do a TAVI. But for this particular patient, if she survives the operation, you’re going to put her back on an almost normal survival curve."
Dr. Borger disclosed consultant fees and honoraria from Medtronic, St. Jude Medical, and Edwards Lifesciences.
CHICAGO – Whether to perform transcatheter aortic valve implantation in a 57-year-old patient with a severely calcified aortic homograft was the subject of a case report presented at Heart Valve Summit 2012.
"In our center, even though we do a huge number of TAVIs [transcatheter aortic valve implantations], we still believe TAVI should be left for the older patients and those with a restricted life expectancy, because the long-term results are not known," said Dr. Michael Borger, assistant director of the Leipzig (Germany) Heart Center.
The patient in this case was a 57 year-old woman who presented with increased shortness of breath and was found to have NYHA II-III heart failure. At age 40, she had received a homograft aortic root replacement for destructive endocarditis.
Her ejection fraction and left ventricular dimensions were preserved, her AV gradient was 86/52 mm Hg, and her effective orifice area (EOA) was 0.6 cm2. She had no other risk factors and was taking no medications. A coronary angiogram showed a severely calcified homograft and isolated proximal stenosis of the right coronary artery.
Dr. Borger discussed two options: redo root replacement surgery with a bypass to the right coronary artery or a transcatheter aortic valve replacement (TAVR) with a PCI to the right coronary artery.
The decision was to perform conventional surgery. "The patient underwent a redo Bentall operation with a mechanical valve, as well as a RIMA (right internal mammary artery) to RCA (right coronary artery) bypass. She did very well postoperatively without any complications," he said.
Aortic root replacements with aortic homografts are not without risk, and the literature shows relatively high mortality for homograft reoperations. Reoperation after stentless AVR also has been performed, but it often requires replacement of the aortic root and is associated with increased mortality (Ann. Thorac. Surg. 2007;84:737-43).
"Most of those [stentless] operations are difficult because of the inability to get a good plane of cleavage between the stentless valve and the native aortic root," said Dr. Borger. "The large majority of those patients end up leaving the OR with a full root replacement."
Dr. Borger’s fellow panelist, Dr. Michael Reardon, agreed. "I was a real fan of the Toronto SPV valve, and ... I’ve taken a couple out," said Dr. Reardon, professor and vice chair of the Methodist DeBakey Heart and Vascular Center in Houston. "They all end up in root replacements. By the time you’re finished you end up having these shards of tissue ... and porcine tissue incites a huge dermoplastic reaction. ... I personally found it very difficult."
Dr. Borger noted, "In Leipzig we have put in a large number of Toronto roots and, knock on wood, have not reoperated on one of them yet. However, they have not yet reached the period whereby you expect to observe structural valve dysfunction."
A study of valve-related events after aortic root replacement with cryopreserved aortic homografts examined risk after placement of a homograft and found that a heavily calcified homograft at the time of reoperation was a significant predictor of death (Ann. Thorac. Surg. 2005;79:1491-5).
"I’m not saying that TAVI is not an option for all young patients," said Dr. Borger. "If you’ve got a young patient who is at very high risk for conventional surgery with lots of comorbidities, whose life expectancy is 5 years or less, then sure, do a TAVI. But for this particular patient, if she survives the operation, you’re going to put her back on an almost normal survival curve."
Dr. Borger disclosed consultant fees and honoraria from Medtronic, St. Jude Medical, and Edwards Lifesciences.
CHICAGO – Whether to perform transcatheter aortic valve implantation in a 57-year-old patient with a severely calcified aortic homograft was the subject of a case report presented at Heart Valve Summit 2012.
"In our center, even though we do a huge number of TAVIs [transcatheter aortic valve implantations], we still believe TAVI should be left for the older patients and those with a restricted life expectancy, because the long-term results are not known," said Dr. Michael Borger, assistant director of the Leipzig (Germany) Heart Center.
The patient in this case was a 57 year-old woman who presented with increased shortness of breath and was found to have NYHA II-III heart failure. At age 40, she had received a homograft aortic root replacement for destructive endocarditis.
Her ejection fraction and left ventricular dimensions were preserved, her AV gradient was 86/52 mm Hg, and her effective orifice area (EOA) was 0.6 cm2. She had no other risk factors and was taking no medications. A coronary angiogram showed a severely calcified homograft and isolated proximal stenosis of the right coronary artery.
Dr. Borger discussed two options: redo root replacement surgery with a bypass to the right coronary artery or a transcatheter aortic valve replacement (TAVR) with a PCI to the right coronary artery.
The decision was to perform conventional surgery. "The patient underwent a redo Bentall operation with a mechanical valve, as well as a RIMA (right internal mammary artery) to RCA (right coronary artery) bypass. She did very well postoperatively without any complications," he said.
Aortic root replacements with aortic homografts are not without risk, and the literature shows relatively high mortality for homograft reoperations. Reoperation after stentless AVR also has been performed, but it often requires replacement of the aortic root and is associated with increased mortality (Ann. Thorac. Surg. 2007;84:737-43).
"Most of those [stentless] operations are difficult because of the inability to get a good plane of cleavage between the stentless valve and the native aortic root," said Dr. Borger. "The large majority of those patients end up leaving the OR with a full root replacement."
Dr. Borger’s fellow panelist, Dr. Michael Reardon, agreed. "I was a real fan of the Toronto SPV valve, and ... I’ve taken a couple out," said Dr. Reardon, professor and vice chair of the Methodist DeBakey Heart and Vascular Center in Houston. "They all end up in root replacements. By the time you’re finished you end up having these shards of tissue ... and porcine tissue incites a huge dermoplastic reaction. ... I personally found it very difficult."
Dr. Borger noted, "In Leipzig we have put in a large number of Toronto roots and, knock on wood, have not reoperated on one of them yet. However, they have not yet reached the period whereby you expect to observe structural valve dysfunction."
A study of valve-related events after aortic root replacement with cryopreserved aortic homografts examined risk after placement of a homograft and found that a heavily calcified homograft at the time of reoperation was a significant predictor of death (Ann. Thorac. Surg. 2005;79:1491-5).
"I’m not saying that TAVI is not an option for all young patients," said Dr. Borger. "If you’ve got a young patient who is at very high risk for conventional surgery with lots of comorbidities, whose life expectancy is 5 years or less, then sure, do a TAVI. But for this particular patient, if she survives the operation, you’re going to put her back on an almost normal survival curve."
Dr. Borger disclosed consultant fees and honoraria from Medtronic, St. Jude Medical, and Edwards Lifesciences.
EXPERT ANALYSIS FROM HEART VALVE SUMMIT 2012
Minimally invasive surgery with sutureless valves shows benefits
CHICAGO – European data suggest that minimally invasive aortic valve surgery has several benefits and few downsides when compared to conventional aortic valve replacement.
Bleeding is decreased, as is ICU and hospital length of stay. Cosmesis is improved. Sutureless valves may facilitate the performance of minimally invasive aortic valve replacement (AVR), and are associated with decreased ischemic times and lower transvalvular gradients – an advantage when concomitant procedures are performed or patients are high risk, according to a presentation at the 2012 Heart Valve summit.
Sutureless aortic valves facilitate minimal basic AVR and minimize myocardial ischemic time, said Dr. Michael Borger of Leipzig (Germany) Heart Center.
He described the evidence to date, as well as his personal experience, at this educational program of the American Association for Thoracic Surgery (AATS) and the American College of Cardiology Foundation (ACCF).
Leipzig Heart Center is one of Europe’s largest cardiac facilities, with 4,000 cardiac operations per year.
The number of patients who undergo minimally invasive aortic valve procedures is still very low, said Dr. Borger, and he urged the audience to consider this option in the future, especially when transcatheter aortic valve implantation (TAVI) becomes as widely accepted in America as it is in Europe. In Germany alone, 31% of isolated AVRs are now done by TAVI.
"Decreased myocardial ischemic time doesn’t matter for someone who needs an isolated aortic valve, [such as a] 70-year-old patient with no risk factors. It doesn’t matter if you shorten their ischemic time by 20 minutes. That’s not the point. The point is that a sutureless valve facilitates minimally invasive surgery by making it easier to do; and a marker for that is decreased ischemic time."
One subgroup of patients who do benefit from decreased ischemic times, however, are those requiring complex multivalve procedures. Patients who have a poor ejection fraction also benefit.
"We are applying lessons that we’ve learned from TAVI to these sutureless valves," said Dr. Borger. "TAVI has been in Europe – transfemoral for 10 years, transapical for 6 years – and what we know from TAVI is that a stent is able to hold an aortic valve in the left ventricular outflow tract and prevent it from embolizing afterwards. In addition, we now know that you do not need to fully decalcify the annulus. As a matter of fact, you’re better off leaving some calcification in the annulus when implanting sutureless valves ... to avoid the formation of annular tears or defects."
There are two approaches: the upper hemisternotomy approach, which is favored in Leipzig, and the upper right midlateral thoracotomy approach.
Three sutureless valves are currently in use in Europe: the Medtronic (formerly ATS) Enable sutureless valve, the Sorin Perceval S sutureless valve, and the Edwards Intuity valve.
The Medtronic Enable valve is equine pericardium and was the first sutureless valve to get CE mark approval in Europe. The literature is limited, but a study from Switzerland (J. Thorac. Cardiovasc. Surg. 2010;140:313-6) of the 3f Enable valve in 28 patients showed that the valve could be implanted safely and quickly with favorable early hemodynamics.
"Again, I just want to stress, the goal is not to go from 60 minutes down to 40 minutes of ischemia; the goal is to facilitate a minimally invasive approach," said Dr. Borger. He noted that the hemodynamics were excellent for all three sutureless valves.
The second valve to receive CE mark approval in Europe was the Sorin Perceval S, at the beginning of 2012. It has a bovine pericardial leaflet, also attached to a Nitinol stent, and is crimped at the bedside. This results in an advantage for implantation.
"You can see exactly that the valve is in the position where you want it to be before deploying it," said Dr. Borger. The long-term results of crimping the leaflets are not yet known.
This particular model is currently available in sizes of 21, 23, and 25 mm. Even a 25-mm valve can only be put in a relatively small annulus, making the Perceval valve most appropriate for the small, elderly patient.
Sorin has reported results from 186 patients who received the Perceval valve, and noted short cross-clamp times (mean cross-clamp time for isolated AVR, 28.6 minutes) and 2.8% mortality.
The third and final sutureless aortic prosthesis is the Edwards Intuity valve, whose top is a traditional design based on the Magna Ease valve, and whose bottom is stent technology borrowed from Edwards’ TAVI program. A recent study of 152 patents revealed an average cross-clamp time of 41 minutes for isolated AVR, with a perioperative mortality rate of 2.1% and a paravalvular leak rate of 1.4% (J. Thorac. Cardiovasc. Surg. 2012;145:110-16). In addition, hemodynamics were excellent, with a mean transvalvular gradient of 9.8 mm Hg.
Dr. Borger disclosed receiving speaking honoraria from Edwards Lifesciences, Medtronic, and St. Jude Medical. He was a researcher in the Edwards Intuity and Sorin Perceval studies.
Leipzig Heart Center,
CHICAGO – European data suggest that minimally invasive aortic valve surgery has several benefits and few downsides when compared to conventional aortic valve replacement.
Bleeding is decreased, as is ICU and hospital length of stay. Cosmesis is improved. Sutureless valves may facilitate the performance of minimally invasive aortic valve replacement (AVR), and are associated with decreased ischemic times and lower transvalvular gradients – an advantage when concomitant procedures are performed or patients are high risk, according to a presentation at the 2012 Heart Valve summit.
Sutureless aortic valves facilitate minimal basic AVR and minimize myocardial ischemic time, said Dr. Michael Borger of Leipzig (Germany) Heart Center.
He described the evidence to date, as well as his personal experience, at this educational program of the American Association for Thoracic Surgery (AATS) and the American College of Cardiology Foundation (ACCF).
Leipzig Heart Center is one of Europe’s largest cardiac facilities, with 4,000 cardiac operations per year.
The number of patients who undergo minimally invasive aortic valve procedures is still very low, said Dr. Borger, and he urged the audience to consider this option in the future, especially when transcatheter aortic valve implantation (TAVI) becomes as widely accepted in America as it is in Europe. In Germany alone, 31% of isolated AVRs are now done by TAVI.
"Decreased myocardial ischemic time doesn’t matter for someone who needs an isolated aortic valve, [such as a] 70-year-old patient with no risk factors. It doesn’t matter if you shorten their ischemic time by 20 minutes. That’s not the point. The point is that a sutureless valve facilitates minimally invasive surgery by making it easier to do; and a marker for that is decreased ischemic time."
One subgroup of patients who do benefit from decreased ischemic times, however, are those requiring complex multivalve procedures. Patients who have a poor ejection fraction also benefit.
"We are applying lessons that we’ve learned from TAVI to these sutureless valves," said Dr. Borger. "TAVI has been in Europe – transfemoral for 10 years, transapical for 6 years – and what we know from TAVI is that a stent is able to hold an aortic valve in the left ventricular outflow tract and prevent it from embolizing afterwards. In addition, we now know that you do not need to fully decalcify the annulus. As a matter of fact, you’re better off leaving some calcification in the annulus when implanting sutureless valves ... to avoid the formation of annular tears or defects."
There are two approaches: the upper hemisternotomy approach, which is favored in Leipzig, and the upper right midlateral thoracotomy approach.
Three sutureless valves are currently in use in Europe: the Medtronic (formerly ATS) Enable sutureless valve, the Sorin Perceval S sutureless valve, and the Edwards Intuity valve.
The Medtronic Enable valve is equine pericardium and was the first sutureless valve to get CE mark approval in Europe. The literature is limited, but a study from Switzerland (J. Thorac. Cardiovasc. Surg. 2010;140:313-6) of the 3f Enable valve in 28 patients showed that the valve could be implanted safely and quickly with favorable early hemodynamics.
"Again, I just want to stress, the goal is not to go from 60 minutes down to 40 minutes of ischemia; the goal is to facilitate a minimally invasive approach," said Dr. Borger. He noted that the hemodynamics were excellent for all three sutureless valves.
The second valve to receive CE mark approval in Europe was the Sorin Perceval S, at the beginning of 2012. It has a bovine pericardial leaflet, also attached to a Nitinol stent, and is crimped at the bedside. This results in an advantage for implantation.
"You can see exactly that the valve is in the position where you want it to be before deploying it," said Dr. Borger. The long-term results of crimping the leaflets are not yet known.
This particular model is currently available in sizes of 21, 23, and 25 mm. Even a 25-mm valve can only be put in a relatively small annulus, making the Perceval valve most appropriate for the small, elderly patient.
Sorin has reported results from 186 patients who received the Perceval valve, and noted short cross-clamp times (mean cross-clamp time for isolated AVR, 28.6 minutes) and 2.8% mortality.
The third and final sutureless aortic prosthesis is the Edwards Intuity valve, whose top is a traditional design based on the Magna Ease valve, and whose bottom is stent technology borrowed from Edwards’ TAVI program. A recent study of 152 patents revealed an average cross-clamp time of 41 minutes for isolated AVR, with a perioperative mortality rate of 2.1% and a paravalvular leak rate of 1.4% (J. Thorac. Cardiovasc. Surg. 2012;145:110-16). In addition, hemodynamics were excellent, with a mean transvalvular gradient of 9.8 mm Hg.
Dr. Borger disclosed receiving speaking honoraria from Edwards Lifesciences, Medtronic, and St. Jude Medical. He was a researcher in the Edwards Intuity and Sorin Perceval studies.
CHICAGO – European data suggest that minimally invasive aortic valve surgery has several benefits and few downsides when compared to conventional aortic valve replacement.
Bleeding is decreased, as is ICU and hospital length of stay. Cosmesis is improved. Sutureless valves may facilitate the performance of minimally invasive aortic valve replacement (AVR), and are associated with decreased ischemic times and lower transvalvular gradients – an advantage when concomitant procedures are performed or patients are high risk, according to a presentation at the 2012 Heart Valve summit.
Sutureless aortic valves facilitate minimal basic AVR and minimize myocardial ischemic time, said Dr. Michael Borger of Leipzig (Germany) Heart Center.
He described the evidence to date, as well as his personal experience, at this educational program of the American Association for Thoracic Surgery (AATS) and the American College of Cardiology Foundation (ACCF).
Leipzig Heart Center is one of Europe’s largest cardiac facilities, with 4,000 cardiac operations per year.
The number of patients who undergo minimally invasive aortic valve procedures is still very low, said Dr. Borger, and he urged the audience to consider this option in the future, especially when transcatheter aortic valve implantation (TAVI) becomes as widely accepted in America as it is in Europe. In Germany alone, 31% of isolated AVRs are now done by TAVI.
"Decreased myocardial ischemic time doesn’t matter for someone who needs an isolated aortic valve, [such as a] 70-year-old patient with no risk factors. It doesn’t matter if you shorten their ischemic time by 20 minutes. That’s not the point. The point is that a sutureless valve facilitates minimally invasive surgery by making it easier to do; and a marker for that is decreased ischemic time."
One subgroup of patients who do benefit from decreased ischemic times, however, are those requiring complex multivalve procedures. Patients who have a poor ejection fraction also benefit.
"We are applying lessons that we’ve learned from TAVI to these sutureless valves," said Dr. Borger. "TAVI has been in Europe – transfemoral for 10 years, transapical for 6 years – and what we know from TAVI is that a stent is able to hold an aortic valve in the left ventricular outflow tract and prevent it from embolizing afterwards. In addition, we now know that you do not need to fully decalcify the annulus. As a matter of fact, you’re better off leaving some calcification in the annulus when implanting sutureless valves ... to avoid the formation of annular tears or defects."
There are two approaches: the upper hemisternotomy approach, which is favored in Leipzig, and the upper right midlateral thoracotomy approach.
Three sutureless valves are currently in use in Europe: the Medtronic (formerly ATS) Enable sutureless valve, the Sorin Perceval S sutureless valve, and the Edwards Intuity valve.
The Medtronic Enable valve is equine pericardium and was the first sutureless valve to get CE mark approval in Europe. The literature is limited, but a study from Switzerland (J. Thorac. Cardiovasc. Surg. 2010;140:313-6) of the 3f Enable valve in 28 patients showed that the valve could be implanted safely and quickly with favorable early hemodynamics.
"Again, I just want to stress, the goal is not to go from 60 minutes down to 40 minutes of ischemia; the goal is to facilitate a minimally invasive approach," said Dr. Borger. He noted that the hemodynamics were excellent for all three sutureless valves.
The second valve to receive CE mark approval in Europe was the Sorin Perceval S, at the beginning of 2012. It has a bovine pericardial leaflet, also attached to a Nitinol stent, and is crimped at the bedside. This results in an advantage for implantation.
"You can see exactly that the valve is in the position where you want it to be before deploying it," said Dr. Borger. The long-term results of crimping the leaflets are not yet known.
This particular model is currently available in sizes of 21, 23, and 25 mm. Even a 25-mm valve can only be put in a relatively small annulus, making the Perceval valve most appropriate for the small, elderly patient.
Sorin has reported results from 186 patients who received the Perceval valve, and noted short cross-clamp times (mean cross-clamp time for isolated AVR, 28.6 minutes) and 2.8% mortality.
The third and final sutureless aortic prosthesis is the Edwards Intuity valve, whose top is a traditional design based on the Magna Ease valve, and whose bottom is stent technology borrowed from Edwards’ TAVI program. A recent study of 152 patents revealed an average cross-clamp time of 41 minutes for isolated AVR, with a perioperative mortality rate of 2.1% and a paravalvular leak rate of 1.4% (J. Thorac. Cardiovasc. Surg. 2012;145:110-16). In addition, hemodynamics were excellent, with a mean transvalvular gradient of 9.8 mm Hg.
Dr. Borger disclosed receiving speaking honoraria from Edwards Lifesciences, Medtronic, and St. Jude Medical. He was a researcher in the Edwards Intuity and Sorin Perceval studies.
Leipzig Heart Center,
Leipzig Heart Center,
EXPERT ANALYSIS FROM HEART VALVE SUMMIT 2012
Early-morning team evaluations slash CCU ventilator time, pneumonia
SAN JUAN, P.R. – To extubate or to keep the patient on a ventilator? That is the question which, when answered by a respiratory therapy team before the next morning’s rounds began, halved the rate of ventilator-associated pneumonias and significantly decreased the time patients spent on ventilators in a surgical critical care unit, investigators reported at the annual Congress of the Society of Critical Care Medicine.
Previously, spontaneous breathing tests had occurred either during or after morning rounds, with extubations being left until sometime later in the day. Under the new protocol, however, respiratory therapists assigned exclusively to the surgical CCU conducted rounds three times daily, consulted with nurses and physicians, and performed spontaneous breathing tests as recommended under joint 2001 guidelines. Thus armed with the information, the multiprofessional team could make the final decision to extubate, and the extubation itself could occur at morning rounds, getting patients off the ventilator that much sooner, said Dr. Vijay Jayaraman, a resident in surgery at the Christiana Care Health System in Wilmington, Del.
Under the new protocol, Dr. Jayaraman and his colleagues saw the rate of ventilator-associated pneumonia (VAP) events decline from 10.8/1,000 ventilator days before the protocol was implemented, to 5.3/1,000 afterward (P less than .05). The mean time to start a spontaneous breathing trial dropped from 2.67 to 1.77 days (P = .004), and the time to extubation was shortened by a full day, 4.47 to 3.43 days (P = .033). There was no difference in days spent in the CCU post extubation, days spent on the patient floor after the CCU stay, or hospital length of stay, Dr. Jayaraman reported.
"This was established in a CCU that was already fully functioning with an active care team. It just required some reorganization, and the most important thing is that the respiratory therapist can be empowered to help us and actively drive the spontaneous breathing test and extubation process," he commented.
Dr. Juliana Barr, who moderated the session at which Dr, Jayaraman presented his study, commented that although myriad other groups have published ventilator-weaning protocols incorporating respiratory therapists, she was not aware of any studies that had previously shown a reduction in VAP rates.
"That was a low-hanging fruit study waiting for someone to do it, and I’m glad that you came along and did that. Thank you," she told Dr. Jayaraman. Dr. Barr is the acting medical director of critical care at the VA Palo Alto (Calif.) Health Care System.
The respiratory team uses predetermined criteria in a coordinated process consisting of awakening patients, performing the spontaneous breathing test, and, whenever possible, making the decision to extubate either before or during rounds.
For the study, the authors prospectively collected data on 180 patients admitted to their 28-bed level 1 surgical CCU from July through December 2010, before the protocol was implemented, and in 219 patients admitted over the same months in 2011, after the protocol had been in place for 6 months.
Extubate when the time is right
In a separate study, investigators from Montefiore Medical Center and other New York City institutions looked at whether outcomes following extubations in the CCU differed according to the time of day.
They retrospectively studied records of 2,240 patients on mechanical ventilation in 1 of 5 CCUs, and found that there were no significant differences in either 24-hour or 72-hour reintubation rates or in morality between patients extubated during daytime hours or during the night.
"Our data provides evidence that nighttime extubation is itself not associated with elevated risk of reintubation or mortality. Patients should be extubated when weaning parameters are met, irrespective of time of day, with appropriate staffing and resources," Dr. Bryan R. Tischenkel said in a poster presentation. Dr. Tischenkel is an anesthesia resident at New York Presbyterian Hospital.
Both studies were internally funded. Dr. Jayaraman, Dr. Barr, and and Dr. Tischenkel each reported having no relevant financial disclosures.
SAN JUAN, P.R. – To extubate or to keep the patient on a ventilator? That is the question which, when answered by a respiratory therapy team before the next morning’s rounds began, halved the rate of ventilator-associated pneumonias and significantly decreased the time patients spent on ventilators in a surgical critical care unit, investigators reported at the annual Congress of the Society of Critical Care Medicine.
Previously, spontaneous breathing tests had occurred either during or after morning rounds, with extubations being left until sometime later in the day. Under the new protocol, however, respiratory therapists assigned exclusively to the surgical CCU conducted rounds three times daily, consulted with nurses and physicians, and performed spontaneous breathing tests as recommended under joint 2001 guidelines. Thus armed with the information, the multiprofessional team could make the final decision to extubate, and the extubation itself could occur at morning rounds, getting patients off the ventilator that much sooner, said Dr. Vijay Jayaraman, a resident in surgery at the Christiana Care Health System in Wilmington, Del.
Under the new protocol, Dr. Jayaraman and his colleagues saw the rate of ventilator-associated pneumonia (VAP) events decline from 10.8/1,000 ventilator days before the protocol was implemented, to 5.3/1,000 afterward (P less than .05). The mean time to start a spontaneous breathing trial dropped from 2.67 to 1.77 days (P = .004), and the time to extubation was shortened by a full day, 4.47 to 3.43 days (P = .033). There was no difference in days spent in the CCU post extubation, days spent on the patient floor after the CCU stay, or hospital length of stay, Dr. Jayaraman reported.
"This was established in a CCU that was already fully functioning with an active care team. It just required some reorganization, and the most important thing is that the respiratory therapist can be empowered to help us and actively drive the spontaneous breathing test and extubation process," he commented.
Dr. Juliana Barr, who moderated the session at which Dr, Jayaraman presented his study, commented that although myriad other groups have published ventilator-weaning protocols incorporating respiratory therapists, she was not aware of any studies that had previously shown a reduction in VAP rates.
"That was a low-hanging fruit study waiting for someone to do it, and I’m glad that you came along and did that. Thank you," she told Dr. Jayaraman. Dr. Barr is the acting medical director of critical care at the VA Palo Alto (Calif.) Health Care System.
The respiratory team uses predetermined criteria in a coordinated process consisting of awakening patients, performing the spontaneous breathing test, and, whenever possible, making the decision to extubate either before or during rounds.
For the study, the authors prospectively collected data on 180 patients admitted to their 28-bed level 1 surgical CCU from July through December 2010, before the protocol was implemented, and in 219 patients admitted over the same months in 2011, after the protocol had been in place for 6 months.
Extubate when the time is right
In a separate study, investigators from Montefiore Medical Center and other New York City institutions looked at whether outcomes following extubations in the CCU differed according to the time of day.
They retrospectively studied records of 2,240 patients on mechanical ventilation in 1 of 5 CCUs, and found that there were no significant differences in either 24-hour or 72-hour reintubation rates or in morality between patients extubated during daytime hours or during the night.
"Our data provides evidence that nighttime extubation is itself not associated with elevated risk of reintubation or mortality. Patients should be extubated when weaning parameters are met, irrespective of time of day, with appropriate staffing and resources," Dr. Bryan R. Tischenkel said in a poster presentation. Dr. Tischenkel is an anesthesia resident at New York Presbyterian Hospital.
Both studies were internally funded. Dr. Jayaraman, Dr. Barr, and and Dr. Tischenkel each reported having no relevant financial disclosures.
SAN JUAN, P.R. – To extubate or to keep the patient on a ventilator? That is the question which, when answered by a respiratory therapy team before the next morning’s rounds began, halved the rate of ventilator-associated pneumonias and significantly decreased the time patients spent on ventilators in a surgical critical care unit, investigators reported at the annual Congress of the Society of Critical Care Medicine.
Previously, spontaneous breathing tests had occurred either during or after morning rounds, with extubations being left until sometime later in the day. Under the new protocol, however, respiratory therapists assigned exclusively to the surgical CCU conducted rounds three times daily, consulted with nurses and physicians, and performed spontaneous breathing tests as recommended under joint 2001 guidelines. Thus armed with the information, the multiprofessional team could make the final decision to extubate, and the extubation itself could occur at morning rounds, getting patients off the ventilator that much sooner, said Dr. Vijay Jayaraman, a resident in surgery at the Christiana Care Health System in Wilmington, Del.
Under the new protocol, Dr. Jayaraman and his colleagues saw the rate of ventilator-associated pneumonia (VAP) events decline from 10.8/1,000 ventilator days before the protocol was implemented, to 5.3/1,000 afterward (P less than .05). The mean time to start a spontaneous breathing trial dropped from 2.67 to 1.77 days (P = .004), and the time to extubation was shortened by a full day, 4.47 to 3.43 days (P = .033). There was no difference in days spent in the CCU post extubation, days spent on the patient floor after the CCU stay, or hospital length of stay, Dr. Jayaraman reported.
"This was established in a CCU that was already fully functioning with an active care team. It just required some reorganization, and the most important thing is that the respiratory therapist can be empowered to help us and actively drive the spontaneous breathing test and extubation process," he commented.
Dr. Juliana Barr, who moderated the session at which Dr, Jayaraman presented his study, commented that although myriad other groups have published ventilator-weaning protocols incorporating respiratory therapists, she was not aware of any studies that had previously shown a reduction in VAP rates.
"That was a low-hanging fruit study waiting for someone to do it, and I’m glad that you came along and did that. Thank you," she told Dr. Jayaraman. Dr. Barr is the acting medical director of critical care at the VA Palo Alto (Calif.) Health Care System.
The respiratory team uses predetermined criteria in a coordinated process consisting of awakening patients, performing the spontaneous breathing test, and, whenever possible, making the decision to extubate either before or during rounds.
For the study, the authors prospectively collected data on 180 patients admitted to their 28-bed level 1 surgical CCU from July through December 2010, before the protocol was implemented, and in 219 patients admitted over the same months in 2011, after the protocol had been in place for 6 months.
Extubate when the time is right
In a separate study, investigators from Montefiore Medical Center and other New York City institutions looked at whether outcomes following extubations in the CCU differed according to the time of day.
They retrospectively studied records of 2,240 patients on mechanical ventilation in 1 of 5 CCUs, and found that there were no significant differences in either 24-hour or 72-hour reintubation rates or in morality between patients extubated during daytime hours or during the night.
"Our data provides evidence that nighttime extubation is itself not associated with elevated risk of reintubation or mortality. Patients should be extubated when weaning parameters are met, irrespective of time of day, with appropriate staffing and resources," Dr. Bryan R. Tischenkel said in a poster presentation. Dr. Tischenkel is an anesthesia resident at New York Presbyterian Hospital.
Both studies were internally funded. Dr. Jayaraman, Dr. Barr, and and Dr. Tischenkel each reported having no relevant financial disclosures.
AT THE ANNUAL CONGRESS OF THE SOCIETY OF CRITICAL CARE MEDICINE
Major finding: Ventilator-associated pneumonia event rates dropped from 10.8 to 5.3/1,000 ventilator days when evaluations for patient extubation were performed before morning rounds.
Data source: A prospective study of 399 patients treated in a 28-bed CCU in Delaware; a retrospective study of records on 2,240 patients treated in five CCUs in New York City hospitals.
Disclosures: Both studies were internally funded. Dr. Jayaraman, Dr. Barr, and and Dr. Tischenkel each reported having no relevant financial disclosures.
Health reform in the second term: The Policy & Practice Podcast
With the start of President Obama’s second term, the high cost of health care is once again a hot topic. And once again, there’s little agreement about how to trim those costs. The President has endorsed the Independent Payment Advisory Board, a 15-member panel charged with slowing the growth in Medicare spending, primarily through provider cuts. But the panel, which was created as part of the Affordable Care Act, doesn’t have a ton of support in Congress – nor among doctors.
Rep. Allyson Schwartz (D-Pa.) and Rep. Phil Roe (R-Tenn.) introduced legislation to repeal the IPAB. The move was cheered by physicians’ groups, which have been highly critical of the unelected panel. Dr. Jeremy Lazarus, president of the American Medical Association, said it would be far better to cut Medicare costs by exploring new care delivery models than simply going after physician pay.
While the IPAB repeal plan has bipartisan support in the House, its chances for success in the Democrat-controlled Senate are less certain.
In other health reform news, a new study shows that focusing on care coordination when patients prepare to leave the hospital can cut down on readmissions and save money. And as governors mull their choice to expand Medicaid, public opinion appears to be divided on the topic. For more details on all these topics, check out this week’s Policy & Practice podcast.
–Mary Ellen Schneider
With the start of President Obama’s second term, the high cost of health care is once again a hot topic. And once again, there’s little agreement about how to trim those costs. The President has endorsed the Independent Payment Advisory Board, a 15-member panel charged with slowing the growth in Medicare spending, primarily through provider cuts. But the panel, which was created as part of the Affordable Care Act, doesn’t have a ton of support in Congress – nor among doctors.
Rep. Allyson Schwartz (D-Pa.) and Rep. Phil Roe (R-Tenn.) introduced legislation to repeal the IPAB. The move was cheered by physicians’ groups, which have been highly critical of the unelected panel. Dr. Jeremy Lazarus, president of the American Medical Association, said it would be far better to cut Medicare costs by exploring new care delivery models than simply going after physician pay.
While the IPAB repeal plan has bipartisan support in the House, its chances for success in the Democrat-controlled Senate are less certain.
In other health reform news, a new study shows that focusing on care coordination when patients prepare to leave the hospital can cut down on readmissions and save money. And as governors mull their choice to expand Medicaid, public opinion appears to be divided on the topic. For more details on all these topics, check out this week’s Policy & Practice podcast.
–Mary Ellen Schneider
With the start of President Obama’s second term, the high cost of health care is once again a hot topic. And once again, there’s little agreement about how to trim those costs. The President has endorsed the Independent Payment Advisory Board, a 15-member panel charged with slowing the growth in Medicare spending, primarily through provider cuts. But the panel, which was created as part of the Affordable Care Act, doesn’t have a ton of support in Congress – nor among doctors.
Rep. Allyson Schwartz (D-Pa.) and Rep. Phil Roe (R-Tenn.) introduced legislation to repeal the IPAB. The move was cheered by physicians’ groups, which have been highly critical of the unelected panel. Dr. Jeremy Lazarus, president of the American Medical Association, said it would be far better to cut Medicare costs by exploring new care delivery models than simply going after physician pay.
While the IPAB repeal plan has bipartisan support in the House, its chances for success in the Democrat-controlled Senate are less certain.
In other health reform news, a new study shows that focusing on care coordination when patients prepare to leave the hospital can cut down on readmissions and save money. And as governors mull their choice to expand Medicaid, public opinion appears to be divided on the topic. For more details on all these topics, check out this week’s Policy & Practice podcast.
–Mary Ellen Schneider
Minimally invasive breast biopsy lags in Texas
PALM BEACH, FLA. – More than a fifth of women in Texas with image-detected breast abnormalities failed to undergo minimally invasive breast biopsy as recently as 2008, according to a review of statewide Medicare data, even though in 2005 a U.S. consensus panel declared the minimally invasive approach the procedure of choice and that few patients should have excisional biopsy as their initial procedure.
The analysis also revealed substantial disparities in use of minimally-invasive breast biopsy (MIBB) relative to open-surgical biopsy. In several rural health service areas (HSA) of Texas during 2005-2008, fewer than 40% of women undergoing biopsy of an image-detected breast abnormality had MIBB, Dr. Taylor S. Riall said at the annual meeting of the Southern Surgical Association. During 2005-2008, 5% of Texas HSAs had MIBB rates greater than 90%, the target set by U.S. cancer organizations. The researchers also identified low levels of MIBB use for Hispanic women, and women of low socioeconomic status.
"Our studies identify targets for interventions to improve MIBB rates, such as the Hispanic disparity and geographic variations in practice pattern," she said. "Our findings highlight that the strategies for intervention need to vary by geographic region and the underlying etiology of the failure to adopt this cost-effective practice," said Dr. Riall, a cancer surgeon at the University of Texas Medical Branch in Galveston.
"This is by far the most detailed study of MIBB [practice patterns] performed to date," commented Dr. Stephen Grobmyer, a surgical oncologist and director of breast services at the Cleveland Clinic.
The data documented that surgeons were an important contributor to MIBB underuse. Throughout the 9 years of data studied by Dr. Riall and her associates during 2001-2008, 70% of MIBB were performed by radiologists, while 26% were performed by surgeons. In contrast, surgeons performed 94% of open, excisional biopsies. When a woman’s breast mass was first identified by a surgeon, 44% of the women had MIBB; when first identified by a primary care physician, 58% had MIBB; when first identified by an oncologist, 59% had MIBB; and when first identified by a gynecologist, 67% had MIBB.
The low levels of MIBB use occurred despite increasingly strong recommendations during the period studied to move MIBB to the forefront of breast-abnormality assessment. In 2001, the first international consensus conference on image-detected breast cancer, organized by the University of Southern California, said that "percutaneous biopsy is the preferred initial diagnostic procedure in most patients with mammographically detected abnormalities"(J. Amer. Coll. Surg. 2001;193:297-302).
In 2005, the second international consensus conference on image-detected breast cancer racheted up the recommendation, saying "minimally invasive breast biopsy is the optimal tissue-acquisition method and the procedure of choice for image-detected breast abnormalities. It should be readily available to all patients with image-detected lesions" (J. Amer. Coll. Surg. 2005;201:586-597).
Although the third international consensus conference did not take place until 2009, the year after the end of the period studied by Dr. Riall, the statement at that time showed how MIBB had become the clear standard of care for biopsy of suspicious breast masses. The 2009 panel said that "percutaneous needle biopsy represents ‘best practice’ and should be the new ‘gold standard’ for initial diagnosis. It should essentially replace open biopsy in this role. The Panel called on the medical community to change their current practice if they are using open surgical breast biopsy as a standard diagnostic procedure. Surgeons should audit their practice and make adjustments to decrease their rate of open biopsy for initial diagnosis to less than 5% to 10%" (J. Amer. Coll. Surg. 2009;209:504-20).
"We need to get a message out to surgeons because they are the ones doing many of the open biopsies," Dr. Riall said in an interview. "Surgeons are a group to target, but we also need to target primary care physicians and other referring physicians so that they understand that MIBB is appropriate. The decision to do MIBB versus open biopsy should be made with the surgeon and with the oncologist who will ultimately treat the breast cancer; the decision should not be made just by a radiologist," who is usually the first person to see a mass when it is first detected by mammography.
Dr. Riall also stressed that the causes of MIBB underuse are multifactorial, and require multiple solutions.
"In very rural areas, the primary problem is access to mammography. In the cases where women cluster in primary care practices that don’t do MIBB, we need to provide better physician education. In regions where there is a high density of private practice surgeons, open biopsy is driven by reimbursement. I think there is an interaction of patient preference, surgeon preference, education and training, geographic region, and availability of radiologists and mammography facilities. Trying to dissect it is very hard."
Her study identified in Texas Medicare records 67,582 unique women aged 66 years or older who underwent 75,518 unique breast mass episodes during 2001-2008, including 49,653 (66%) of masses that underwent MIBB and 25,865 (34%) that underwent open surgical biopsy. Use of MIBB rose steadily during the period, starting at 44% of masses in 2001 and increasing to 79% by 2008.
Analysis of MIBB use by Medicare health service area showed stark geographic disparities, with MIBB use as low as 21% in one HSA. During 2005-2008, MIBB use remained at 40% or less in several HSA along the Rio Grande border and in East Texas, including the HSAs in the south Texas towns of McAllen and Harlingen. In contrast, the HSA immediately adjacent to these that includes Brownsville had a MIBB rate greater than 70%. The analysis also showed than many of the HSAs with the lowest rates of MIBB use were located in Texas regions with high Hispanic populations, Dr. Riall said.
Dr. Riall and Dr. Grobmyer had no disclosures.
Current guidelines strongly endorse minimally-invasive breast biopsy as the standard for establishing the histologic diagnosis of a breast mass before interventional treatment. Minimally-invasive breast biopsy reduces the interval between diagnosis and starting therapy, and reduces cost compared with an open technique.
The report by Dr. Riall and her associates also touches on a legal aspect that demands our attention. Currently, about 20% of U.S. medical litigation centers on cases involving breast cancer and delayed diagnosis of these cancers. The demographic disparities in care that they identified in their study mean that it is essential for us to identify and resolve the specific barriers to performing minimally-invasive breast biopsy in certain regions and among certain groups of patients. In doing this, we could better achieve the goal of using the minimally-invasive approach in greater than 90% of patients, both in Texas and throughout the United States.
The principle reason why these barriers exist is possibly related to improper insurance coverage and inadequate access to the necessary technology. It is not surprising to me that 70% of the minimally-invasive biopsies were performed by radiologists, while only 26% were done by surgeons. Our goal should be to make access to this contemporary technology available to the entire U.S. population.
Dr. Kirby I. Bland is a surgical oncologist and professor and chairman of surgery at the University of Alabama, Birmingham. He made these comments as a designated discussant of the report. He had no disclosures.
Current guidelines strongly endorse minimally-invasive breast biopsy as the standard for establishing the histologic diagnosis of a breast mass before interventional treatment. Minimally-invasive breast biopsy reduces the interval between diagnosis and starting therapy, and reduces cost compared with an open technique.
The report by Dr. Riall and her associates also touches on a legal aspect that demands our attention. Currently, about 20% of U.S. medical litigation centers on cases involving breast cancer and delayed diagnosis of these cancers. The demographic disparities in care that they identified in their study mean that it is essential for us to identify and resolve the specific barriers to performing minimally-invasive breast biopsy in certain regions and among certain groups of patients. In doing this, we could better achieve the goal of using the minimally-invasive approach in greater than 90% of patients, both in Texas and throughout the United States.
The principle reason why these barriers exist is possibly related to improper insurance coverage and inadequate access to the necessary technology. It is not surprising to me that 70% of the minimally-invasive biopsies were performed by radiologists, while only 26% were done by surgeons. Our goal should be to make access to this contemporary technology available to the entire U.S. population.
Dr. Kirby I. Bland is a surgical oncologist and professor and chairman of surgery at the University of Alabama, Birmingham. He made these comments as a designated discussant of the report. He had no disclosures.
Current guidelines strongly endorse minimally-invasive breast biopsy as the standard for establishing the histologic diagnosis of a breast mass before interventional treatment. Minimally-invasive breast biopsy reduces the interval between diagnosis and starting therapy, and reduces cost compared with an open technique.
The report by Dr. Riall and her associates also touches on a legal aspect that demands our attention. Currently, about 20% of U.S. medical litigation centers on cases involving breast cancer and delayed diagnosis of these cancers. The demographic disparities in care that they identified in their study mean that it is essential for us to identify and resolve the specific barriers to performing minimally-invasive breast biopsy in certain regions and among certain groups of patients. In doing this, we could better achieve the goal of using the minimally-invasive approach in greater than 90% of patients, both in Texas and throughout the United States.
The principle reason why these barriers exist is possibly related to improper insurance coverage and inadequate access to the necessary technology. It is not surprising to me that 70% of the minimally-invasive biopsies were performed by radiologists, while only 26% were done by surgeons. Our goal should be to make access to this contemporary technology available to the entire U.S. population.
Dr. Kirby I. Bland is a surgical oncologist and professor and chairman of surgery at the University of Alabama, Birmingham. He made these comments as a designated discussant of the report. He had no disclosures.
PALM BEACH, FLA. – More than a fifth of women in Texas with image-detected breast abnormalities failed to undergo minimally invasive breast biopsy as recently as 2008, according to a review of statewide Medicare data, even though in 2005 a U.S. consensus panel declared the minimally invasive approach the procedure of choice and that few patients should have excisional biopsy as their initial procedure.
The analysis also revealed substantial disparities in use of minimally-invasive breast biopsy (MIBB) relative to open-surgical biopsy. In several rural health service areas (HSA) of Texas during 2005-2008, fewer than 40% of women undergoing biopsy of an image-detected breast abnormality had MIBB, Dr. Taylor S. Riall said at the annual meeting of the Southern Surgical Association. During 2005-2008, 5% of Texas HSAs had MIBB rates greater than 90%, the target set by U.S. cancer organizations. The researchers also identified low levels of MIBB use for Hispanic women, and women of low socioeconomic status.
"Our studies identify targets for interventions to improve MIBB rates, such as the Hispanic disparity and geographic variations in practice pattern," she said. "Our findings highlight that the strategies for intervention need to vary by geographic region and the underlying etiology of the failure to adopt this cost-effective practice," said Dr. Riall, a cancer surgeon at the University of Texas Medical Branch in Galveston.
"This is by far the most detailed study of MIBB [practice patterns] performed to date," commented Dr. Stephen Grobmyer, a surgical oncologist and director of breast services at the Cleveland Clinic.
The data documented that surgeons were an important contributor to MIBB underuse. Throughout the 9 years of data studied by Dr. Riall and her associates during 2001-2008, 70% of MIBB were performed by radiologists, while 26% were performed by surgeons. In contrast, surgeons performed 94% of open, excisional biopsies. When a woman’s breast mass was first identified by a surgeon, 44% of the women had MIBB; when first identified by a primary care physician, 58% had MIBB; when first identified by an oncologist, 59% had MIBB; and when first identified by a gynecologist, 67% had MIBB.
The low levels of MIBB use occurred despite increasingly strong recommendations during the period studied to move MIBB to the forefront of breast-abnormality assessment. In 2001, the first international consensus conference on image-detected breast cancer, organized by the University of Southern California, said that "percutaneous biopsy is the preferred initial diagnostic procedure in most patients with mammographically detected abnormalities"(J. Amer. Coll. Surg. 2001;193:297-302).
In 2005, the second international consensus conference on image-detected breast cancer racheted up the recommendation, saying "minimally invasive breast biopsy is the optimal tissue-acquisition method and the procedure of choice for image-detected breast abnormalities. It should be readily available to all patients with image-detected lesions" (J. Amer. Coll. Surg. 2005;201:586-597).
Although the third international consensus conference did not take place until 2009, the year after the end of the period studied by Dr. Riall, the statement at that time showed how MIBB had become the clear standard of care for biopsy of suspicious breast masses. The 2009 panel said that "percutaneous needle biopsy represents ‘best practice’ and should be the new ‘gold standard’ for initial diagnosis. It should essentially replace open biopsy in this role. The Panel called on the medical community to change their current practice if they are using open surgical breast biopsy as a standard diagnostic procedure. Surgeons should audit their practice and make adjustments to decrease their rate of open biopsy for initial diagnosis to less than 5% to 10%" (J. Amer. Coll. Surg. 2009;209:504-20).
"We need to get a message out to surgeons because they are the ones doing many of the open biopsies," Dr. Riall said in an interview. "Surgeons are a group to target, but we also need to target primary care physicians and other referring physicians so that they understand that MIBB is appropriate. The decision to do MIBB versus open biopsy should be made with the surgeon and with the oncologist who will ultimately treat the breast cancer; the decision should not be made just by a radiologist," who is usually the first person to see a mass when it is first detected by mammography.
Dr. Riall also stressed that the causes of MIBB underuse are multifactorial, and require multiple solutions.
"In very rural areas, the primary problem is access to mammography. In the cases where women cluster in primary care practices that don’t do MIBB, we need to provide better physician education. In regions where there is a high density of private practice surgeons, open biopsy is driven by reimbursement. I think there is an interaction of patient preference, surgeon preference, education and training, geographic region, and availability of radiologists and mammography facilities. Trying to dissect it is very hard."
Her study identified in Texas Medicare records 67,582 unique women aged 66 years or older who underwent 75,518 unique breast mass episodes during 2001-2008, including 49,653 (66%) of masses that underwent MIBB and 25,865 (34%) that underwent open surgical biopsy. Use of MIBB rose steadily during the period, starting at 44% of masses in 2001 and increasing to 79% by 2008.
Analysis of MIBB use by Medicare health service area showed stark geographic disparities, with MIBB use as low as 21% in one HSA. During 2005-2008, MIBB use remained at 40% or less in several HSA along the Rio Grande border and in East Texas, including the HSAs in the south Texas towns of McAllen and Harlingen. In contrast, the HSA immediately adjacent to these that includes Brownsville had a MIBB rate greater than 70%. The analysis also showed than many of the HSAs with the lowest rates of MIBB use were located in Texas regions with high Hispanic populations, Dr. Riall said.
Dr. Riall and Dr. Grobmyer had no disclosures.
PALM BEACH, FLA. – More than a fifth of women in Texas with image-detected breast abnormalities failed to undergo minimally invasive breast biopsy as recently as 2008, according to a review of statewide Medicare data, even though in 2005 a U.S. consensus panel declared the minimally invasive approach the procedure of choice and that few patients should have excisional biopsy as their initial procedure.
The analysis also revealed substantial disparities in use of minimally-invasive breast biopsy (MIBB) relative to open-surgical biopsy. In several rural health service areas (HSA) of Texas during 2005-2008, fewer than 40% of women undergoing biopsy of an image-detected breast abnormality had MIBB, Dr. Taylor S. Riall said at the annual meeting of the Southern Surgical Association. During 2005-2008, 5% of Texas HSAs had MIBB rates greater than 90%, the target set by U.S. cancer organizations. The researchers also identified low levels of MIBB use for Hispanic women, and women of low socioeconomic status.
"Our studies identify targets for interventions to improve MIBB rates, such as the Hispanic disparity and geographic variations in practice pattern," she said. "Our findings highlight that the strategies for intervention need to vary by geographic region and the underlying etiology of the failure to adopt this cost-effective practice," said Dr. Riall, a cancer surgeon at the University of Texas Medical Branch in Galveston.
"This is by far the most detailed study of MIBB [practice patterns] performed to date," commented Dr. Stephen Grobmyer, a surgical oncologist and director of breast services at the Cleveland Clinic.
The data documented that surgeons were an important contributor to MIBB underuse. Throughout the 9 years of data studied by Dr. Riall and her associates during 2001-2008, 70% of MIBB were performed by radiologists, while 26% were performed by surgeons. In contrast, surgeons performed 94% of open, excisional biopsies. When a woman’s breast mass was first identified by a surgeon, 44% of the women had MIBB; when first identified by a primary care physician, 58% had MIBB; when first identified by an oncologist, 59% had MIBB; and when first identified by a gynecologist, 67% had MIBB.
The low levels of MIBB use occurred despite increasingly strong recommendations during the period studied to move MIBB to the forefront of breast-abnormality assessment. In 2001, the first international consensus conference on image-detected breast cancer, organized by the University of Southern California, said that "percutaneous biopsy is the preferred initial diagnostic procedure in most patients with mammographically detected abnormalities"(J. Amer. Coll. Surg. 2001;193:297-302).
In 2005, the second international consensus conference on image-detected breast cancer racheted up the recommendation, saying "minimally invasive breast biopsy is the optimal tissue-acquisition method and the procedure of choice for image-detected breast abnormalities. It should be readily available to all patients with image-detected lesions" (J. Amer. Coll. Surg. 2005;201:586-597).
Although the third international consensus conference did not take place until 2009, the year after the end of the period studied by Dr. Riall, the statement at that time showed how MIBB had become the clear standard of care for biopsy of suspicious breast masses. The 2009 panel said that "percutaneous needle biopsy represents ‘best practice’ and should be the new ‘gold standard’ for initial diagnosis. It should essentially replace open biopsy in this role. The Panel called on the medical community to change their current practice if they are using open surgical breast biopsy as a standard diagnostic procedure. Surgeons should audit their practice and make adjustments to decrease their rate of open biopsy for initial diagnosis to less than 5% to 10%" (J. Amer. Coll. Surg. 2009;209:504-20).
"We need to get a message out to surgeons because they are the ones doing many of the open biopsies," Dr. Riall said in an interview. "Surgeons are a group to target, but we also need to target primary care physicians and other referring physicians so that they understand that MIBB is appropriate. The decision to do MIBB versus open biopsy should be made with the surgeon and with the oncologist who will ultimately treat the breast cancer; the decision should not be made just by a radiologist," who is usually the first person to see a mass when it is first detected by mammography.
Dr. Riall also stressed that the causes of MIBB underuse are multifactorial, and require multiple solutions.
"In very rural areas, the primary problem is access to mammography. In the cases where women cluster in primary care practices that don’t do MIBB, we need to provide better physician education. In regions where there is a high density of private practice surgeons, open biopsy is driven by reimbursement. I think there is an interaction of patient preference, surgeon preference, education and training, geographic region, and availability of radiologists and mammography facilities. Trying to dissect it is very hard."
Her study identified in Texas Medicare records 67,582 unique women aged 66 years or older who underwent 75,518 unique breast mass episodes during 2001-2008, including 49,653 (66%) of masses that underwent MIBB and 25,865 (34%) that underwent open surgical biopsy. Use of MIBB rose steadily during the period, starting at 44% of masses in 2001 and increasing to 79% by 2008.
Analysis of MIBB use by Medicare health service area showed stark geographic disparities, with MIBB use as low as 21% in one HSA. During 2005-2008, MIBB use remained at 40% or less in several HSA along the Rio Grande border and in East Texas, including the HSAs in the south Texas towns of McAllen and Harlingen. In contrast, the HSA immediately adjacent to these that includes Brownsville had a MIBB rate greater than 70%. The analysis also showed than many of the HSAs with the lowest rates of MIBB use were located in Texas regions with high Hispanic populations, Dr. Riall said.
Dr. Riall and Dr. Grobmyer had no disclosures.
AT THE ANNUAL MEETING OF THE SOUTHERN SURGICAL ASSOCIATION
Major Finding: During 2008, 79% of Texas women aged 66 years or older undergoing breast biopsy had a minimally-invasive procedure.
Data Source: A review of Texas Medicare claims data for 67,582 women who underwent a breast mass biopsy during 2001-2008.
Disclosures: Dr. Riall and Dr. Grobmyer had no disclosures.
Uterine artery embolization effective for fertility preservation
Women younger than age 40 years who undergo uterine artery embolization for the treatment of uterine fibroids have a good chance of maintaining fertility and of having a good pregnancy outcome, even years following the procedure, according to findings from a retrospective chart review.
The findings suggest that for women who desire a future pregnancy, uterine artery embolization may offer advantages over myomectomy, Dr. Bruce McLucas reported at ISET 2013, an international symposium on endovascular therapy.
Of 44 women aged 26-40 years who desired a future pregnancy and who underwent uterine artery embolization between 1996 and 2010, 22 reported a total of 28 pregnancies. One patient had three pregnancies, 4 had two pregnancies, and 17 had one pregnancy.
The pregnancies occurred at a mean of 41 months following treatment (range of 13 to 108 months from treatment to delivery). Only one patient required the use of "additional reproductive techniques," said Dr. McLucas of the University of California, Los Angeles.
Of the 28 pregnancies, 3 resulted in miscarriage, 3 involved preterm labor followed by cesarean delivery, 18 involved cesarean delivery at term, and 4 involved vaginal delivery at term – something that is not possible following myomectomy, he said.
The average birth weight of the babies was a healthy 3 kg, and mean total uterine volume prior to uterine artery embolization was also healthy at 400.6 cm. The average fibroid size prior to the treatment was 8.46 cm.
No perfusion problems occurred during pregnancy or labor, and there were no reports of any intrauterine growth restriction, fetal distress during labor, or problems related to uterine integrity. Also, none of the patients experienced premature menopause as a result of uterine artery embolization.
In fact, only two patients reported problems during pregnancy, and these included borderline oligohydramnios and low-lying placenta.
The pregnancy rate in this study compares favorably with the rate seen in previous studies of women who underwent myomectomy. Because about 10% of myomectomies result in conversion to hysterectomy and because vaginal delivery is not possible following myomectomy, these findings suggest that uterine artery embolization is a viable alternative, Dr. McLucas said.
This is particularly true for those who wish to wait longer than 1 year after the procedure to become pregnant, which is the case for many younger patients, he said. It takes about 6 months for the uterus to heal following myomectomy, and the chances of becoming pregnant are best between and 7 and 12 months following myomectomy. After 12 months, fibroids begin to recur, hindering the chances of conception.
Women should be advised of the small chance of premature ovarian failure (which occurs in about 10 in 1,000 cases) and of hysterectomy (which occurs in about 5 in 1,000 cases) with uterine artery embolization. Nonetheless, the treatment is a good option in those who desire to maintain fertility and to postpone childbearing, he concluded.
Dr. McLucas reported having no financial disclosures.
Women younger than age 40 years who undergo uterine artery embolization for the treatment of uterine fibroids have a good chance of maintaining fertility and of having a good pregnancy outcome, even years following the procedure, according to findings from a retrospective chart review.
The findings suggest that for women who desire a future pregnancy, uterine artery embolization may offer advantages over myomectomy, Dr. Bruce McLucas reported at ISET 2013, an international symposium on endovascular therapy.
Of 44 women aged 26-40 years who desired a future pregnancy and who underwent uterine artery embolization between 1996 and 2010, 22 reported a total of 28 pregnancies. One patient had three pregnancies, 4 had two pregnancies, and 17 had one pregnancy.
The pregnancies occurred at a mean of 41 months following treatment (range of 13 to 108 months from treatment to delivery). Only one patient required the use of "additional reproductive techniques," said Dr. McLucas of the University of California, Los Angeles.
Of the 28 pregnancies, 3 resulted in miscarriage, 3 involved preterm labor followed by cesarean delivery, 18 involved cesarean delivery at term, and 4 involved vaginal delivery at term – something that is not possible following myomectomy, he said.
The average birth weight of the babies was a healthy 3 kg, and mean total uterine volume prior to uterine artery embolization was also healthy at 400.6 cm. The average fibroid size prior to the treatment was 8.46 cm.
No perfusion problems occurred during pregnancy or labor, and there were no reports of any intrauterine growth restriction, fetal distress during labor, or problems related to uterine integrity. Also, none of the patients experienced premature menopause as a result of uterine artery embolization.
In fact, only two patients reported problems during pregnancy, and these included borderline oligohydramnios and low-lying placenta.
The pregnancy rate in this study compares favorably with the rate seen in previous studies of women who underwent myomectomy. Because about 10% of myomectomies result in conversion to hysterectomy and because vaginal delivery is not possible following myomectomy, these findings suggest that uterine artery embolization is a viable alternative, Dr. McLucas said.
This is particularly true for those who wish to wait longer than 1 year after the procedure to become pregnant, which is the case for many younger patients, he said. It takes about 6 months for the uterus to heal following myomectomy, and the chances of becoming pregnant are best between and 7 and 12 months following myomectomy. After 12 months, fibroids begin to recur, hindering the chances of conception.
Women should be advised of the small chance of premature ovarian failure (which occurs in about 10 in 1,000 cases) and of hysterectomy (which occurs in about 5 in 1,000 cases) with uterine artery embolization. Nonetheless, the treatment is a good option in those who desire to maintain fertility and to postpone childbearing, he concluded.
Dr. McLucas reported having no financial disclosures.
Women younger than age 40 years who undergo uterine artery embolization for the treatment of uterine fibroids have a good chance of maintaining fertility and of having a good pregnancy outcome, even years following the procedure, according to findings from a retrospective chart review.
The findings suggest that for women who desire a future pregnancy, uterine artery embolization may offer advantages over myomectomy, Dr. Bruce McLucas reported at ISET 2013, an international symposium on endovascular therapy.
Of 44 women aged 26-40 years who desired a future pregnancy and who underwent uterine artery embolization between 1996 and 2010, 22 reported a total of 28 pregnancies. One patient had three pregnancies, 4 had two pregnancies, and 17 had one pregnancy.
The pregnancies occurred at a mean of 41 months following treatment (range of 13 to 108 months from treatment to delivery). Only one patient required the use of "additional reproductive techniques," said Dr. McLucas of the University of California, Los Angeles.
Of the 28 pregnancies, 3 resulted in miscarriage, 3 involved preterm labor followed by cesarean delivery, 18 involved cesarean delivery at term, and 4 involved vaginal delivery at term – something that is not possible following myomectomy, he said.
The average birth weight of the babies was a healthy 3 kg, and mean total uterine volume prior to uterine artery embolization was also healthy at 400.6 cm. The average fibroid size prior to the treatment was 8.46 cm.
No perfusion problems occurred during pregnancy or labor, and there were no reports of any intrauterine growth restriction, fetal distress during labor, or problems related to uterine integrity. Also, none of the patients experienced premature menopause as a result of uterine artery embolization.
In fact, only two patients reported problems during pregnancy, and these included borderline oligohydramnios and low-lying placenta.
The pregnancy rate in this study compares favorably with the rate seen in previous studies of women who underwent myomectomy. Because about 10% of myomectomies result in conversion to hysterectomy and because vaginal delivery is not possible following myomectomy, these findings suggest that uterine artery embolization is a viable alternative, Dr. McLucas said.
This is particularly true for those who wish to wait longer than 1 year after the procedure to become pregnant, which is the case for many younger patients, he said. It takes about 6 months for the uterus to heal following myomectomy, and the chances of becoming pregnant are best between and 7 and 12 months following myomectomy. After 12 months, fibroids begin to recur, hindering the chances of conception.
Women should be advised of the small chance of premature ovarian failure (which occurs in about 10 in 1,000 cases) and of hysterectomy (which occurs in about 5 in 1,000 cases) with uterine artery embolization. Nonetheless, the treatment is a good option in those who desire to maintain fertility and to postpone childbearing, he concluded.
Dr. McLucas reported having no financial disclosures.
FROM ISET 2013, AN INTERNATIONAL SYMPOSIUM ON ENDOVASCULAR THERAPY
Major Finding: Of 44 women aged 26-40 years who desired a future pregnancy and who underwent uterine artery embolization for uterine fibroids between 1996 and 2010, 22 reported a total of 28 pregnancies, which occurred at a mean of 41 months following treatment.
Data Source: A patient chart review.
Disclosures: Dr. McLucas reported having no disclosures.
Calif. hospitals support feds in quality goals
Nearly 400 California hospitals have pledged to lower preventable hospital-acquired conditions and hospital readmissions as part of a federal quality initiative.
More Golden State hospitals have agreed to participate in the federal Partnership for Patients initiative than any other state in the nation. The project, which is being led by the Centers for Medicare and Medicaid Services, aims to decrease preventable hospital-acquired conditions by 40% and hospital readmissions by 20% by the end of 2013. Officials at CMS estimate that achieving these goals will prevent more than 3.4 million injuries and complications nationwide.
"Under the Partnership for Patients initiative, we are providing support to help hospitals provide high-quality care and keep their patients healthy," Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation, said in a statement. "Participating in this initiative will help California hospitals improve health outcomes and reduce complications for their patients."
Hospitals are getting some federal support under the initiative. The federal government has awarded $218 million to 26 organizations that are serving as Hospital Engagement Networks. These networks are developing learning collaboratives for hospitals, conducting training programs, providing technical assistance, identifying and disseminating best practices, and establishing systems for tracking and monitoring hospital progress in meeting quality improvement goals.
Nearly 400 California hospitals have pledged to lower preventable hospital-acquired conditions and hospital readmissions as part of a federal quality initiative.
More Golden State hospitals have agreed to participate in the federal Partnership for Patients initiative than any other state in the nation. The project, which is being led by the Centers for Medicare and Medicaid Services, aims to decrease preventable hospital-acquired conditions by 40% and hospital readmissions by 20% by the end of 2013. Officials at CMS estimate that achieving these goals will prevent more than 3.4 million injuries and complications nationwide.
"Under the Partnership for Patients initiative, we are providing support to help hospitals provide high-quality care and keep their patients healthy," Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation, said in a statement. "Participating in this initiative will help California hospitals improve health outcomes and reduce complications for their patients."
Hospitals are getting some federal support under the initiative. The federal government has awarded $218 million to 26 organizations that are serving as Hospital Engagement Networks. These networks are developing learning collaboratives for hospitals, conducting training programs, providing technical assistance, identifying and disseminating best practices, and establishing systems for tracking and monitoring hospital progress in meeting quality improvement goals.
Nearly 400 California hospitals have pledged to lower preventable hospital-acquired conditions and hospital readmissions as part of a federal quality initiative.
More Golden State hospitals have agreed to participate in the federal Partnership for Patients initiative than any other state in the nation. The project, which is being led by the Centers for Medicare and Medicaid Services, aims to decrease preventable hospital-acquired conditions by 40% and hospital readmissions by 20% by the end of 2013. Officials at CMS estimate that achieving these goals will prevent more than 3.4 million injuries and complications nationwide.
"Under the Partnership for Patients initiative, we are providing support to help hospitals provide high-quality care and keep their patients healthy," Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation, said in a statement. "Participating in this initiative will help California hospitals improve health outcomes and reduce complications for their patients."
Hospitals are getting some federal support under the initiative. The federal government has awarded $218 million to 26 organizations that are serving as Hospital Engagement Networks. These networks are developing learning collaboratives for hospitals, conducting training programs, providing technical assistance, identifying and disseminating best practices, and establishing systems for tracking and monitoring hospital progress in meeting quality improvement goals.
New strain of norovirus wreaks havoc
A new strain of norovirus, identified last March in Australia, has swept through the United States, causing more than half of the 2012 outbreaks.
GII.4 Sydney is implicated in 53% of the outbreaks that occurred from September to December, Leslie Barclay and her colleagues reported in the Jan. 24 issue of the Morbidity and Mortality Weekly Report (2013;62:55).
The other outbreaks were caused by 10 different GI and GII genotypes, including GII.4 New Orleans, said Ms. Barclay of the National Calicivirus Laboratory at the Centers for Disease Control and Prevention, and her coauthors. However, she noted, the GII.4 Sydney virus appears to have replaced the New Orleans strain as the predominant pathogen.
GII.4 Sydney was implicated in 19% of the September norovirus outbreaks; 46% of the October outbreaks; and 58% of outbreaks in both November and December, Ms. Barclay and her coinvestigators said.
The report noted that 51% of the outbreaks were direct, person-to-person transmission; 20% were foodborne; and 1% waterborne. For the other outbreaks, the mode of transmission remains unknown.
The sudden appearance of a new norovirus strain isn’t unusual or unexpected, Dr. Aron J. Hall said in an interview.
"This group of viruses is constantly evolving. New strains develop all the time," said Dr. Hall, an epidemiologist with CDC’s Division of Viral Diseases. "This is following the same pattern we’ve seen for the past 10 years, with a new strain evolving every 2-3 years."
Since the norovirus season doesn’t normally peak until January, it’s too soon to say whether GII.4 Sydney is more virulent, either in the number or severity of cases it causes.
"Every time a new strain emerges, there’s a potential for increased disease activity, numbers of outbreaks, and severity. But sometimes they simply replace the predominant strain with no increases. We have to wait until we’ve tallied all the numbers before we can get an assessment of this season’s magnitude and impact," he said.
GII.4 Sydney was first identified in Australia, and rapidly moved to Japan, the Netherlands, and the United Kingdom, according to a Jan. 4 report (Eurosurv. 2013;18:1)
In early December and late November, the ProMed disease reporting system reported a 64% increase in confirmed norovirus lab reports in England and Wales, and increased deaths in elderly Japanese patients. Molecular assays pinpointed the cause as the new variant of norovirus, the Eurosurveillance researchers noted.
The virus is highly transmissible; exposure to as few as 18 viral particles can cause illness, according to a presentation by Jan Vinjé, Ph.D., head of the National Calicivirus Laboratory. And since about 30% of cases are asymptomatic, the transmission rate can be extremely high.
"These are the two characteristics that explain why norovirus is such a serious public health challenge," Dr. Hall said. "It takes a very tiny amount of exposure to make someone sick, and someone who is sick is shedding billions of viral particles. They can shed virus without any symptoms, so they don’t know they have it and there’s no way to advise them about how to avoid spreading it."
The illness is characterized by vomiting and/or diarrhea with abdominal cramps and low-grade fever. Most patients recover within 12-72 hours, but about 10% need hospitalization and fluid therapy. Severe illness and/or death are most common among the elderly and people with chronic illnesses.
The United States sees about 21 million cases annually; 800 will result in death. A norovirus outbreak can overwhelm local medical resources; the virus causes nearly 2 million outpatient visits and 400,000 emergency department visits each year. The combined annual cost reaches $2 billion, according to the CDC.
As federal employees, Dr. Hall and Ms. Barclay have no financial disclosures.
GII.4 Sydney, Leslie Barclay, Morbidity and Mortality Weekly Report, GII.4 New Orleans, National Calicivirus Laboratory at the Centers for Disease Control and Prevention, Dr. Aron J. Hall, CDC’s Division of Viral Diseases,
A new strain of norovirus, identified last March in Australia, has swept through the United States, causing more than half of the 2012 outbreaks.
GII.4 Sydney is implicated in 53% of the outbreaks that occurred from September to December, Leslie Barclay and her colleagues reported in the Jan. 24 issue of the Morbidity and Mortality Weekly Report (2013;62:55).
The other outbreaks were caused by 10 different GI and GII genotypes, including GII.4 New Orleans, said Ms. Barclay of the National Calicivirus Laboratory at the Centers for Disease Control and Prevention, and her coauthors. However, she noted, the GII.4 Sydney virus appears to have replaced the New Orleans strain as the predominant pathogen.
GII.4 Sydney was implicated in 19% of the September norovirus outbreaks; 46% of the October outbreaks; and 58% of outbreaks in both November and December, Ms. Barclay and her coinvestigators said.
The report noted that 51% of the outbreaks were direct, person-to-person transmission; 20% were foodborne; and 1% waterborne. For the other outbreaks, the mode of transmission remains unknown.
The sudden appearance of a new norovirus strain isn’t unusual or unexpected, Dr. Aron J. Hall said in an interview.
"This group of viruses is constantly evolving. New strains develop all the time," said Dr. Hall, an epidemiologist with CDC’s Division of Viral Diseases. "This is following the same pattern we’ve seen for the past 10 years, with a new strain evolving every 2-3 years."
Since the norovirus season doesn’t normally peak until January, it’s too soon to say whether GII.4 Sydney is more virulent, either in the number or severity of cases it causes.
"Every time a new strain emerges, there’s a potential for increased disease activity, numbers of outbreaks, and severity. But sometimes they simply replace the predominant strain with no increases. We have to wait until we’ve tallied all the numbers before we can get an assessment of this season’s magnitude and impact," he said.
GII.4 Sydney was first identified in Australia, and rapidly moved to Japan, the Netherlands, and the United Kingdom, according to a Jan. 4 report (Eurosurv. 2013;18:1)
In early December and late November, the ProMed disease reporting system reported a 64% increase in confirmed norovirus lab reports in England and Wales, and increased deaths in elderly Japanese patients. Molecular assays pinpointed the cause as the new variant of norovirus, the Eurosurveillance researchers noted.
The virus is highly transmissible; exposure to as few as 18 viral particles can cause illness, according to a presentation by Jan Vinjé, Ph.D., head of the National Calicivirus Laboratory. And since about 30% of cases are asymptomatic, the transmission rate can be extremely high.
"These are the two characteristics that explain why norovirus is such a serious public health challenge," Dr. Hall said. "It takes a very tiny amount of exposure to make someone sick, and someone who is sick is shedding billions of viral particles. They can shed virus without any symptoms, so they don’t know they have it and there’s no way to advise them about how to avoid spreading it."
The illness is characterized by vomiting and/or diarrhea with abdominal cramps and low-grade fever. Most patients recover within 12-72 hours, but about 10% need hospitalization and fluid therapy. Severe illness and/or death are most common among the elderly and people with chronic illnesses.
The United States sees about 21 million cases annually; 800 will result in death. A norovirus outbreak can overwhelm local medical resources; the virus causes nearly 2 million outpatient visits and 400,000 emergency department visits each year. The combined annual cost reaches $2 billion, according to the CDC.
As federal employees, Dr. Hall and Ms. Barclay have no financial disclosures.
A new strain of norovirus, identified last March in Australia, has swept through the United States, causing more than half of the 2012 outbreaks.
GII.4 Sydney is implicated in 53% of the outbreaks that occurred from September to December, Leslie Barclay and her colleagues reported in the Jan. 24 issue of the Morbidity and Mortality Weekly Report (2013;62:55).
The other outbreaks were caused by 10 different GI and GII genotypes, including GII.4 New Orleans, said Ms. Barclay of the National Calicivirus Laboratory at the Centers for Disease Control and Prevention, and her coauthors. However, she noted, the GII.4 Sydney virus appears to have replaced the New Orleans strain as the predominant pathogen.
GII.4 Sydney was implicated in 19% of the September norovirus outbreaks; 46% of the October outbreaks; and 58% of outbreaks in both November and December, Ms. Barclay and her coinvestigators said.
The report noted that 51% of the outbreaks were direct, person-to-person transmission; 20% were foodborne; and 1% waterborne. For the other outbreaks, the mode of transmission remains unknown.
The sudden appearance of a new norovirus strain isn’t unusual or unexpected, Dr. Aron J. Hall said in an interview.
"This group of viruses is constantly evolving. New strains develop all the time," said Dr. Hall, an epidemiologist with CDC’s Division of Viral Diseases. "This is following the same pattern we’ve seen for the past 10 years, with a new strain evolving every 2-3 years."
Since the norovirus season doesn’t normally peak until January, it’s too soon to say whether GII.4 Sydney is more virulent, either in the number or severity of cases it causes.
"Every time a new strain emerges, there’s a potential for increased disease activity, numbers of outbreaks, and severity. But sometimes they simply replace the predominant strain with no increases. We have to wait until we’ve tallied all the numbers before we can get an assessment of this season’s magnitude and impact," he said.
GII.4 Sydney was first identified in Australia, and rapidly moved to Japan, the Netherlands, and the United Kingdom, according to a Jan. 4 report (Eurosurv. 2013;18:1)
In early December and late November, the ProMed disease reporting system reported a 64% increase in confirmed norovirus lab reports in England and Wales, and increased deaths in elderly Japanese patients. Molecular assays pinpointed the cause as the new variant of norovirus, the Eurosurveillance researchers noted.
The virus is highly transmissible; exposure to as few as 18 viral particles can cause illness, according to a presentation by Jan Vinjé, Ph.D., head of the National Calicivirus Laboratory. And since about 30% of cases are asymptomatic, the transmission rate can be extremely high.
"These are the two characteristics that explain why norovirus is such a serious public health challenge," Dr. Hall said. "It takes a very tiny amount of exposure to make someone sick, and someone who is sick is shedding billions of viral particles. They can shed virus without any symptoms, so they don’t know they have it and there’s no way to advise them about how to avoid spreading it."
The illness is characterized by vomiting and/or diarrhea with abdominal cramps and low-grade fever. Most patients recover within 12-72 hours, but about 10% need hospitalization and fluid therapy. Severe illness and/or death are most common among the elderly and people with chronic illnesses.
The United States sees about 21 million cases annually; 800 will result in death. A norovirus outbreak can overwhelm local medical resources; the virus causes nearly 2 million outpatient visits and 400,000 emergency department visits each year. The combined annual cost reaches $2 billion, according to the CDC.
As federal employees, Dr. Hall and Ms. Barclay have no financial disclosures.
GII.4 Sydney, Leslie Barclay, Morbidity and Mortality Weekly Report, GII.4 New Orleans, National Calicivirus Laboratory at the Centers for Disease Control and Prevention, Dr. Aron J. Hall, CDC’s Division of Viral Diseases,
GII.4 Sydney, Leslie Barclay, Morbidity and Mortality Weekly Report, GII.4 New Orleans, National Calicivirus Laboratory at the Centers for Disease Control and Prevention, Dr. Aron J. Hall, CDC’s Division of Viral Diseases,
FROM THE MORBIDITY AND MORTALITY WEEKLY REPORT
Major Finding: A new strain of norovirus caused 53% of outbreaks in the United States from September-December 2012.
Data Source: These statistics were obtained from the Centers for Disease Control and Prevention’s National Calicivirus Laboratory
Disclosures: As federal employees, Dr. Hall and Ms. Barclay have no financial disclosures.
Resecting residual gastrointestinal stromal tumors improved survival
SAN FRANCISCO – Surgically removing residual gastrointestinal stromal tumors in patients who respond to imatinib therapy significantly increased time to tumor progression to 88 months, compared with 43 months using imatinib alone, based on findings from a retrospective study of 134 patients.
After controlling for the effects of other risk factors, the surgery decreased threefold the likelihood of disease progression and decreased fivefold the risk of death, Dr. Seong Joon Park reported in a press briefing sponsored by the American Society of Clinical Oncology (ASCO). The press conference was held in advance of at a meeting on gastrointestinal cancers sponsored by ASCO and three other cancer organizations.
The findings support the widely adopted practice of removing residual tumors in these patients, despite the retrospective and observational design of the study, Dr. Park said. A prospective European study of similar design to this one terminated early due to poor patient enrollment. "It’s really hard to conduct a prospective study of this design," said Dr. Park of Asan Medical Center, Seoul, South Korea.
He and his associates reviewed the records of patients who showed at least 6 months of disease stabilization or response to imatinib (Gleevec) treatment, 92 of whom got the drug treatment alone and 42 of whom underwent surgery to remove residual tumors after a median of 19 months of imatinib therapy. The imatinib therapy was restarted after surgery. Median follow-up for the cohort as a whole was 59 months.
"This treatment strategy is worth trying as a clinical practice if the medical center is large enough to have an experienced multidisciplinary team and to have low morbidity and mortality associated with surgery," he said.
Each year, approximately 5,000 new cases of gastrointestinal stromal tumors are diagnosed in the United States, most often in the stomach and small intestine, though they can occur anywhere in or near the GI tract. Imatinib typically is first-line therapy, and 80%-85% of patients will respond to the treatment, he said. A majority of patients who respond to imatinib will have residual tumors, however, which are believed to contribute to the development of drug resistance, leading to the hypothesis that removing the residual tumors would improve survival.
In general, one-third of patients are candidates for surgical removal of residual lesions, depending on the tumor size and other tumor and patient characteristics, Dr. Park said.
The two patient groups in the study were similar except that the surgery group was significantly younger (51 vs. 58 years) and was less likely to have metastases in the peritoneum (41% in the surgery group vs. 61% in the control group).
As it is an aggressive and difficult treatment, surgery is more likely to be considered and recommended to younger patients who have a good performance status and, thus, less likely to be recommended in patients with multiple peritoneal metastases.
Factors associated with longer progression-free and overall survival included surgery and having an initial tumor size less than 150 mm, multivariate analyses showed. Female sex and having the KIT exon 11 mutation also were associated with longer progression-free survival. The researchers used propensity scores and inverse-probability-weighting adjustments to account for the effects of factors other than surgery.
The gastrointestinal cancers meeting, where Dr. Park will present the results, is cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Park reported having no financial disclosures.
On Twitter @sherryboschert
GI stromal tumors are an uncommon type of gastrointestinal tumor that can arise at many different places within the GI tract. This disease is notable because it’s really been a triumph of molecularly targeted therapy with imatinib (Gleevec), a drug that targets a particular molecular abnormality present in GI stromal tumors. Because of this, there is an extremely high response rate in patients with GI stromal tumors and drug therapy can control the disease for years.
Unfortunately, resistance ultimately develops to imatinib. This study provides provocative evidence that taking an aggressive approach surgically in addition to medical treatment with imatinib may result in longer survival of patients with GI stromal tumors.
Dr. Neal J. Meropol is chief of hematology and oncology at Case Western Reserve University, Cleveland. He gave these comments as moderator of the press briefing. He has been a consultant or advisor to Precision Therapeutics.
GI stromal tumors are an uncommon type of gastrointestinal tumor that can arise at many different places within the GI tract. This disease is notable because it’s really been a triumph of molecularly targeted therapy with imatinib (Gleevec), a drug that targets a particular molecular abnormality present in GI stromal tumors. Because of this, there is an extremely high response rate in patients with GI stromal tumors and drug therapy can control the disease for years.
Unfortunately, resistance ultimately develops to imatinib. This study provides provocative evidence that taking an aggressive approach surgically in addition to medical treatment with imatinib may result in longer survival of patients with GI stromal tumors.
Dr. Neal J. Meropol is chief of hematology and oncology at Case Western Reserve University, Cleveland. He gave these comments as moderator of the press briefing. He has been a consultant or advisor to Precision Therapeutics.
GI stromal tumors are an uncommon type of gastrointestinal tumor that can arise at many different places within the GI tract. This disease is notable because it’s really been a triumph of molecularly targeted therapy with imatinib (Gleevec), a drug that targets a particular molecular abnormality present in GI stromal tumors. Because of this, there is an extremely high response rate in patients with GI stromal tumors and drug therapy can control the disease for years.
Unfortunately, resistance ultimately develops to imatinib. This study provides provocative evidence that taking an aggressive approach surgically in addition to medical treatment with imatinib may result in longer survival of patients with GI stromal tumors.
Dr. Neal J. Meropol is chief of hematology and oncology at Case Western Reserve University, Cleveland. He gave these comments as moderator of the press briefing. He has been a consultant or advisor to Precision Therapeutics.
SAN FRANCISCO – Surgically removing residual gastrointestinal stromal tumors in patients who respond to imatinib therapy significantly increased time to tumor progression to 88 months, compared with 43 months using imatinib alone, based on findings from a retrospective study of 134 patients.
After controlling for the effects of other risk factors, the surgery decreased threefold the likelihood of disease progression and decreased fivefold the risk of death, Dr. Seong Joon Park reported in a press briefing sponsored by the American Society of Clinical Oncology (ASCO). The press conference was held in advance of at a meeting on gastrointestinal cancers sponsored by ASCO and three other cancer organizations.
The findings support the widely adopted practice of removing residual tumors in these patients, despite the retrospective and observational design of the study, Dr. Park said. A prospective European study of similar design to this one terminated early due to poor patient enrollment. "It’s really hard to conduct a prospective study of this design," said Dr. Park of Asan Medical Center, Seoul, South Korea.
He and his associates reviewed the records of patients who showed at least 6 months of disease stabilization or response to imatinib (Gleevec) treatment, 92 of whom got the drug treatment alone and 42 of whom underwent surgery to remove residual tumors after a median of 19 months of imatinib therapy. The imatinib therapy was restarted after surgery. Median follow-up for the cohort as a whole was 59 months.
"This treatment strategy is worth trying as a clinical practice if the medical center is large enough to have an experienced multidisciplinary team and to have low morbidity and mortality associated with surgery," he said.
Each year, approximately 5,000 new cases of gastrointestinal stromal tumors are diagnosed in the United States, most often in the stomach and small intestine, though they can occur anywhere in or near the GI tract. Imatinib typically is first-line therapy, and 80%-85% of patients will respond to the treatment, he said. A majority of patients who respond to imatinib will have residual tumors, however, which are believed to contribute to the development of drug resistance, leading to the hypothesis that removing the residual tumors would improve survival.
In general, one-third of patients are candidates for surgical removal of residual lesions, depending on the tumor size and other tumor and patient characteristics, Dr. Park said.
The two patient groups in the study were similar except that the surgery group was significantly younger (51 vs. 58 years) and was less likely to have metastases in the peritoneum (41% in the surgery group vs. 61% in the control group).
As it is an aggressive and difficult treatment, surgery is more likely to be considered and recommended to younger patients who have a good performance status and, thus, less likely to be recommended in patients with multiple peritoneal metastases.
Factors associated with longer progression-free and overall survival included surgery and having an initial tumor size less than 150 mm, multivariate analyses showed. Female sex and having the KIT exon 11 mutation also were associated with longer progression-free survival. The researchers used propensity scores and inverse-probability-weighting adjustments to account for the effects of factors other than surgery.
The gastrointestinal cancers meeting, where Dr. Park will present the results, is cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Park reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Surgically removing residual gastrointestinal stromal tumors in patients who respond to imatinib therapy significantly increased time to tumor progression to 88 months, compared with 43 months using imatinib alone, based on findings from a retrospective study of 134 patients.
After controlling for the effects of other risk factors, the surgery decreased threefold the likelihood of disease progression and decreased fivefold the risk of death, Dr. Seong Joon Park reported in a press briefing sponsored by the American Society of Clinical Oncology (ASCO). The press conference was held in advance of at a meeting on gastrointestinal cancers sponsored by ASCO and three other cancer organizations.
The findings support the widely adopted practice of removing residual tumors in these patients, despite the retrospective and observational design of the study, Dr. Park said. A prospective European study of similar design to this one terminated early due to poor patient enrollment. "It’s really hard to conduct a prospective study of this design," said Dr. Park of Asan Medical Center, Seoul, South Korea.
He and his associates reviewed the records of patients who showed at least 6 months of disease stabilization or response to imatinib (Gleevec) treatment, 92 of whom got the drug treatment alone and 42 of whom underwent surgery to remove residual tumors after a median of 19 months of imatinib therapy. The imatinib therapy was restarted after surgery. Median follow-up for the cohort as a whole was 59 months.
"This treatment strategy is worth trying as a clinical practice if the medical center is large enough to have an experienced multidisciplinary team and to have low morbidity and mortality associated with surgery," he said.
Each year, approximately 5,000 new cases of gastrointestinal stromal tumors are diagnosed in the United States, most often in the stomach and small intestine, though they can occur anywhere in or near the GI tract. Imatinib typically is first-line therapy, and 80%-85% of patients will respond to the treatment, he said. A majority of patients who respond to imatinib will have residual tumors, however, which are believed to contribute to the development of drug resistance, leading to the hypothesis that removing the residual tumors would improve survival.
In general, one-third of patients are candidates for surgical removal of residual lesions, depending on the tumor size and other tumor and patient characteristics, Dr. Park said.
The two patient groups in the study were similar except that the surgery group was significantly younger (51 vs. 58 years) and was less likely to have metastases in the peritoneum (41% in the surgery group vs. 61% in the control group).
As it is an aggressive and difficult treatment, surgery is more likely to be considered and recommended to younger patients who have a good performance status and, thus, less likely to be recommended in patients with multiple peritoneal metastases.
Factors associated with longer progression-free and overall survival included surgery and having an initial tumor size less than 150 mm, multivariate analyses showed. Female sex and having the KIT exon 11 mutation also were associated with longer progression-free survival. The researchers used propensity scores and inverse-probability-weighting adjustments to account for the effects of factors other than surgery.
The gastrointestinal cancers meeting, where Dr. Park will present the results, is cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
Dr. Park reported having no financial disclosures.
On Twitter @sherryboschert
FROM A PRESS BRIEFING SPONSORED BY THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Major Finding: Time to tumor progression was 88 months in 42 patients who had surgery for residual disease and 42 months in 92 patients given imatinib alone. Metastases in the peritoneum were present in 41% of the imatinib-and-surgery group and 61% of the imatinib-only group.
Data Source: Retrospective study of 134 patients with metastatic or recurrent gastrointestinal tumors who showed at least 6 months of disease stabilization or response to imatinib, 42 of whom had residual tumors resected.
Disclosures: Dr. Park reported having no financial disclosures.
Pigtail catheters less painful than chest tubes for traumatic pneumothorax
In patients with traumatic pneumothorax, smaller really is better, a study has shown.
The prospective, randomized study found that 14-French pigtail catheters function as well as do traditional, large-bore 28-French chest tubes, and result in significantly less tube-site pain.
The average numerical rating tube-site pain score was 3.2 with the pigtail catheter vs. 7.7 with the chest tube on the day of insertion, 1.9 vs. 6.2 on day 1 (both P values less than .001), and 2.1 vs. 5.5 on day 2 (P = .04).
Chest wall pain was similar between the two groups at all three time points (6.1 vs. 6.0; 5.5 vs. 5.9; and 4.2 vs. 5.9), as was intravenous pain medication use on day 1 (mean 10.3 U vs. 15.4 U) and day 2 (5.0 U vs. 8.6 U). One unit equaled 1 mg morphine, 25 mcg fentanyl, or 0.1 mg hydromorphone HCl (Dilaudid).
It stands to reason that the pigtail catheters are less painful because they’re soft, have a coiled tip, and are inserted with a less-invasive percutaneous technique, whereas traditional, large-bore chest tubes are straight and stiff, and are typically placed via a cutdown technique, Dr. Narong Kulvatunyou said at the annual meeting of the Eastern Association for the Surgery of Trauma.
A recent prospective observational study found no difference in tube-site pain with large (36- to 40-French) versus small (28- to 32-French) chest tubes inserted for chest trauma (J. Trauma Acute Care Surg. 2012;72:422-7), but the analysis still compared two large bores and both used the cutdown technique, he observed.
Based on their early experience in trauma patients, Dr. Kulvatunyou and his colleagues at the University of Arizona, Tucson, reported that 11% of pigtail catheters failed versus 4% of chest tubes (P = .06) (J. Trauma 2011;71:1104-7).
The 2-year review did not assess tube-site pain, prompting the current prospective study involving 40 patients with traumatic pneumothorax evenly randomized to a 14F pigtail catheter placed at the bedside with a modified Seldinger technique or a 28F chest tube placed via a cutdown technique. The tubes were left on suction for 24 hours.
Patients were excluded if they required emergency pigtail or chest tube placement or were unable to respond to the nurse-led pain assessment.
Demographics in the pigtail and chest tube groups were similar in average Injury Severity Score (14.5 vs. 12.2), abbreviated chest injury score (3 vs. 3), blunt trauma injury (85% vs. 80%), rib fractures (both 1.5), and pulmonary contusion (both 25%). Patients’ mean age was 46 years; 80% were male.
Contrary to expectations, tube-site pain was similar whether the pigtail catheter was placed anteriorly between the second and third rib (n = 9) or laterally (n = 11) between the fourth and fifth rib, Dr. Kulvatunyou said.
Failure rate, defined as unresolved or recurrent pneumothorax requiring a second tube, was 5% in the pigtail group and 10% in the chest tube group (P = .55). Secondary endpoints included insertion-related complications (10% for both groups), median number of tube days (2 for both), and median hospital stay (4 days for both).
Invited discussant Dr. David King, a trauma and acute care surgeon at Massachusetts General Hospital, Boston, questioned whether patients were receiving oral pain medications, as this could impact the results, and how the team mitigated a potential Hawthorne effect and observer bias.
"I know you said that the nurses who were getting the pain scores were blinded, but it’s pretty difficult to blind someone to the difference between a garden hose and a straw coming out of their chest wall," he said.
Dr. Kulvatunyou acknowledged that 10 out of 10 patients would prefer a smaller tube if asked, but that patients were asked only whether they would be willing to receive a "different tube that works pretty well," with no mention of tube size. As for the nurses, he said the tubes were typically under dressings and that some nurses may not have noticed the difference – a remark that was not well received based on comments after the session.
Data on oral medications were not collected because they were rarely used in the first 2 days and it was difficult to compare the oral medications, but Dr. Kulvatunyou said the point was well taken.
He noted that pigtail catheters could have a role in other traumatic indications such as hemothorax, hemopneumothorax, and emergency situations, but that additional studies are needed to show that it has equal efficacy to those chest tubes.
"I’m sure everyone puts central lines in pretty quickly, so just imagine if you could do pigtails just as quick as central lines," he said. "It would change everything."
Dr. Kulvatunyou, his coauthors, and Dr. King reported no relevant financial disclosures.
In patients with traumatic pneumothorax, smaller really is better, a study has shown.
The prospective, randomized study found that 14-French pigtail catheters function as well as do traditional, large-bore 28-French chest tubes, and result in significantly less tube-site pain.
The average numerical rating tube-site pain score was 3.2 with the pigtail catheter vs. 7.7 with the chest tube on the day of insertion, 1.9 vs. 6.2 on day 1 (both P values less than .001), and 2.1 vs. 5.5 on day 2 (P = .04).
Chest wall pain was similar between the two groups at all three time points (6.1 vs. 6.0; 5.5 vs. 5.9; and 4.2 vs. 5.9), as was intravenous pain medication use on day 1 (mean 10.3 U vs. 15.4 U) and day 2 (5.0 U vs. 8.6 U). One unit equaled 1 mg morphine, 25 mcg fentanyl, or 0.1 mg hydromorphone HCl (Dilaudid).
It stands to reason that the pigtail catheters are less painful because they’re soft, have a coiled tip, and are inserted with a less-invasive percutaneous technique, whereas traditional, large-bore chest tubes are straight and stiff, and are typically placed via a cutdown technique, Dr. Narong Kulvatunyou said at the annual meeting of the Eastern Association for the Surgery of Trauma.
A recent prospective observational study found no difference in tube-site pain with large (36- to 40-French) versus small (28- to 32-French) chest tubes inserted for chest trauma (J. Trauma Acute Care Surg. 2012;72:422-7), but the analysis still compared two large bores and both used the cutdown technique, he observed.
Based on their early experience in trauma patients, Dr. Kulvatunyou and his colleagues at the University of Arizona, Tucson, reported that 11% of pigtail catheters failed versus 4% of chest tubes (P = .06) (J. Trauma 2011;71:1104-7).
The 2-year review did not assess tube-site pain, prompting the current prospective study involving 40 patients with traumatic pneumothorax evenly randomized to a 14F pigtail catheter placed at the bedside with a modified Seldinger technique or a 28F chest tube placed via a cutdown technique. The tubes were left on suction for 24 hours.
Patients were excluded if they required emergency pigtail or chest tube placement or were unable to respond to the nurse-led pain assessment.
Demographics in the pigtail and chest tube groups were similar in average Injury Severity Score (14.5 vs. 12.2), abbreviated chest injury score (3 vs. 3), blunt trauma injury (85% vs. 80%), rib fractures (both 1.5), and pulmonary contusion (both 25%). Patients’ mean age was 46 years; 80% were male.
Contrary to expectations, tube-site pain was similar whether the pigtail catheter was placed anteriorly between the second and third rib (n = 9) or laterally (n = 11) between the fourth and fifth rib, Dr. Kulvatunyou said.
Failure rate, defined as unresolved or recurrent pneumothorax requiring a second tube, was 5% in the pigtail group and 10% in the chest tube group (P = .55). Secondary endpoints included insertion-related complications (10% for both groups), median number of tube days (2 for both), and median hospital stay (4 days for both).
Invited discussant Dr. David King, a trauma and acute care surgeon at Massachusetts General Hospital, Boston, questioned whether patients were receiving oral pain medications, as this could impact the results, and how the team mitigated a potential Hawthorne effect and observer bias.
"I know you said that the nurses who were getting the pain scores were blinded, but it’s pretty difficult to blind someone to the difference between a garden hose and a straw coming out of their chest wall," he said.
Dr. Kulvatunyou acknowledged that 10 out of 10 patients would prefer a smaller tube if asked, but that patients were asked only whether they would be willing to receive a "different tube that works pretty well," with no mention of tube size. As for the nurses, he said the tubes were typically under dressings and that some nurses may not have noticed the difference – a remark that was not well received based on comments after the session.
Data on oral medications were not collected because they were rarely used in the first 2 days and it was difficult to compare the oral medications, but Dr. Kulvatunyou said the point was well taken.
He noted that pigtail catheters could have a role in other traumatic indications such as hemothorax, hemopneumothorax, and emergency situations, but that additional studies are needed to show that it has equal efficacy to those chest tubes.
"I’m sure everyone puts central lines in pretty quickly, so just imagine if you could do pigtails just as quick as central lines," he said. "It would change everything."
Dr. Kulvatunyou, his coauthors, and Dr. King reported no relevant financial disclosures.
In patients with traumatic pneumothorax, smaller really is better, a study has shown.
The prospective, randomized study found that 14-French pigtail catheters function as well as do traditional, large-bore 28-French chest tubes, and result in significantly less tube-site pain.
The average numerical rating tube-site pain score was 3.2 with the pigtail catheter vs. 7.7 with the chest tube on the day of insertion, 1.9 vs. 6.2 on day 1 (both P values less than .001), and 2.1 vs. 5.5 on day 2 (P = .04).
Chest wall pain was similar between the two groups at all three time points (6.1 vs. 6.0; 5.5 vs. 5.9; and 4.2 vs. 5.9), as was intravenous pain medication use on day 1 (mean 10.3 U vs. 15.4 U) and day 2 (5.0 U vs. 8.6 U). One unit equaled 1 mg morphine, 25 mcg fentanyl, or 0.1 mg hydromorphone HCl (Dilaudid).
It stands to reason that the pigtail catheters are less painful because they’re soft, have a coiled tip, and are inserted with a less-invasive percutaneous technique, whereas traditional, large-bore chest tubes are straight and stiff, and are typically placed via a cutdown technique, Dr. Narong Kulvatunyou said at the annual meeting of the Eastern Association for the Surgery of Trauma.
A recent prospective observational study found no difference in tube-site pain with large (36- to 40-French) versus small (28- to 32-French) chest tubes inserted for chest trauma (J. Trauma Acute Care Surg. 2012;72:422-7), but the analysis still compared two large bores and both used the cutdown technique, he observed.
Based on their early experience in trauma patients, Dr. Kulvatunyou and his colleagues at the University of Arizona, Tucson, reported that 11% of pigtail catheters failed versus 4% of chest tubes (P = .06) (J. Trauma 2011;71:1104-7).
The 2-year review did not assess tube-site pain, prompting the current prospective study involving 40 patients with traumatic pneumothorax evenly randomized to a 14F pigtail catheter placed at the bedside with a modified Seldinger technique or a 28F chest tube placed via a cutdown technique. The tubes were left on suction for 24 hours.
Patients were excluded if they required emergency pigtail or chest tube placement or were unable to respond to the nurse-led pain assessment.
Demographics in the pigtail and chest tube groups were similar in average Injury Severity Score (14.5 vs. 12.2), abbreviated chest injury score (3 vs. 3), blunt trauma injury (85% vs. 80%), rib fractures (both 1.5), and pulmonary contusion (both 25%). Patients’ mean age was 46 years; 80% were male.
Contrary to expectations, tube-site pain was similar whether the pigtail catheter was placed anteriorly between the second and third rib (n = 9) or laterally (n = 11) between the fourth and fifth rib, Dr. Kulvatunyou said.
Failure rate, defined as unresolved or recurrent pneumothorax requiring a second tube, was 5% in the pigtail group and 10% in the chest tube group (P = .55). Secondary endpoints included insertion-related complications (10% for both groups), median number of tube days (2 for both), and median hospital stay (4 days for both).
Invited discussant Dr. David King, a trauma and acute care surgeon at Massachusetts General Hospital, Boston, questioned whether patients were receiving oral pain medications, as this could impact the results, and how the team mitigated a potential Hawthorne effect and observer bias.
"I know you said that the nurses who were getting the pain scores were blinded, but it’s pretty difficult to blind someone to the difference between a garden hose and a straw coming out of their chest wall," he said.
Dr. Kulvatunyou acknowledged that 10 out of 10 patients would prefer a smaller tube if asked, but that patients were asked only whether they would be willing to receive a "different tube that works pretty well," with no mention of tube size. As for the nurses, he said the tubes were typically under dressings and that some nurses may not have noticed the difference – a remark that was not well received based on comments after the session.
Data on oral medications were not collected because they were rarely used in the first 2 days and it was difficult to compare the oral medications, but Dr. Kulvatunyou said the point was well taken.
He noted that pigtail catheters could have a role in other traumatic indications such as hemothorax, hemopneumothorax, and emergency situations, but that additional studies are needed to show that it has equal efficacy to those chest tubes.
"I’m sure everyone puts central lines in pretty quickly, so just imagine if you could do pigtails just as quick as central lines," he said. "It would change everything."
Dr. Kulvatunyou, his coauthors, and Dr. King reported no relevant financial disclosures.
AT THE ANNUAL MEETING OF THE EASTERN ASSOCIATION FOR THE SURGERY OF TRAUMA
Major Finding: The average tube-site pain score was 3.2 with the pigtail catheter vs. 7.7 with the chest tube on the day of insertion, 1.9 vs. 6.2 on day 1 (both P values less than .001), and 2.1 vs. 5.5 on day 2 (P = .04).
Data Source: A prospective, randomized trial of 40 patients with traumatic pneumothorax.
Disclosures: Dr. Kulvatunyou, his coauthors, and Dr. King reported no relevant financial disclosures.