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More physicians excluded from MIPS under final CMS rule
More doctors will be exempt from participation in the Merit-Based Incentive Payment System in 2018, under a final rule issued by the Health & Human Service department.
The final rule excludes from MIPS participation any health care providers who are part of an advanced alternative payment model (APM), those who have $90,000 or less in Medicare Part B billings or who see 200 or fewer Medicare patients. For the 2017 reporting year, those levels were $30,000 and 100 patients.
In comments when the rule was a draft, many organizations suggested that CMS allow clinicians who are ready to participate in MIPS to opt in even if they fall into the MIPS low-volume threshold category. While the agency did not codify this suggestion, officials noted that they intend “revisit this policy in future rule making and are seeking comment on methods to implement this policy in a low-burden manner.”
Medical societies were generally in favor of the new higher threshold, but it was met with resistance from associations representing group practices.
“The transition to value is challenging and CMS understandably want to ease providers into value,” Jerry Penso, MD, president and CEO of the American Medical Group Association said in a statement. “But excluding providers isn’t the same as learning how to deliver care in a value-based world. Taking accountability for the quality and cost of care requires years of experience. Despite CMS’ intentions to ensure a smooth transition, AMGA is concerned that this rule actually hinders the prospects for value-based care.”
CMS is providing a number of enhancements for small practices participating in MIPS.
Small practices (15 or fewer providers) will get five bonus points under MIPS and will continue to earn points for partial data reporting of quality measures. They also will be able to join virtual groups to help aggregate their reporting and improve abilities to access payment bonuses. (Find a link to download a virtual group toolkit on page 4 of the CMS fact sheet for the final rule.)
CMS also is slowly phasing into the cost performance category, which will account for 10% of a MIPS score and will include Medicare spending per beneficiary and total per capita cost measures. These measures are carried over from the Value Modifier program and will require no action from providers to calculate. CMS will measure the performance in this category.
Finally, the agency included a hardship exemption for those affected by major hurricanes in the Gulf Coast and Puerto Rico in 2017. Currently, those who lost access to their EHRs because of the hurricanes, other natural disasters, or public health emergencies, they can file a hardship exemption to have their Advancing Care Information (formerly the meaningful use program) score reweighted to reflect the issues. Applications must be filed by Dec. 31, 2017. The final rule extends the reweighting policy to the other three categories (quality, cost, and improvement activities) through the 2018 performance year, with a deadline of Dec. 31, 2018, to file for a hardship exemption.
“Because our policies relating to reweighting the quality, cost, and improvement activities performance categories are not effective until next year, we are issuing an interim final rule for automatic extreme and uncontrollable circumstances where clinicians can be exempt form these categories in the transition year without submitting a hardship exception application,” CMS noted in the fact sheet. For 2017, that means clinicians in areas affected by the hurricanes who do not submit data will not receive any negative adjustment, Clinicians who do submit data will be scored as usual.
On the advanced APM track, under which physicians take on more risk in exchange for a potential for greater bonus payments, CMS said it is making it easier for clinicians to participate, including extending certain revenue and expenditure provisions for an additional 2 years that are used to determine nominal risk, changing the medical home models to slower the increase of the minimal amount of financial risk taken on, and making it easier for clinicians to earn bonus payments for APMs that begin or end mid-year.
The final rule is scheduled for publication in the Federal Register on Nov. 16.
More doctors will be exempt from participation in the Merit-Based Incentive Payment System in 2018, under a final rule issued by the Health & Human Service department.
The final rule excludes from MIPS participation any health care providers who are part of an advanced alternative payment model (APM), those who have $90,000 or less in Medicare Part B billings or who see 200 or fewer Medicare patients. For the 2017 reporting year, those levels were $30,000 and 100 patients.
In comments when the rule was a draft, many organizations suggested that CMS allow clinicians who are ready to participate in MIPS to opt in even if they fall into the MIPS low-volume threshold category. While the agency did not codify this suggestion, officials noted that they intend “revisit this policy in future rule making and are seeking comment on methods to implement this policy in a low-burden manner.”
Medical societies were generally in favor of the new higher threshold, but it was met with resistance from associations representing group practices.
“The transition to value is challenging and CMS understandably want to ease providers into value,” Jerry Penso, MD, president and CEO of the American Medical Group Association said in a statement. “But excluding providers isn’t the same as learning how to deliver care in a value-based world. Taking accountability for the quality and cost of care requires years of experience. Despite CMS’ intentions to ensure a smooth transition, AMGA is concerned that this rule actually hinders the prospects for value-based care.”
CMS is providing a number of enhancements for small practices participating in MIPS.
Small practices (15 or fewer providers) will get five bonus points under MIPS and will continue to earn points for partial data reporting of quality measures. They also will be able to join virtual groups to help aggregate their reporting and improve abilities to access payment bonuses. (Find a link to download a virtual group toolkit on page 4 of the CMS fact sheet for the final rule.)
CMS also is slowly phasing into the cost performance category, which will account for 10% of a MIPS score and will include Medicare spending per beneficiary and total per capita cost measures. These measures are carried over from the Value Modifier program and will require no action from providers to calculate. CMS will measure the performance in this category.
Finally, the agency included a hardship exemption for those affected by major hurricanes in the Gulf Coast and Puerto Rico in 2017. Currently, those who lost access to their EHRs because of the hurricanes, other natural disasters, or public health emergencies, they can file a hardship exemption to have their Advancing Care Information (formerly the meaningful use program) score reweighted to reflect the issues. Applications must be filed by Dec. 31, 2017. The final rule extends the reweighting policy to the other three categories (quality, cost, and improvement activities) through the 2018 performance year, with a deadline of Dec. 31, 2018, to file for a hardship exemption.
“Because our policies relating to reweighting the quality, cost, and improvement activities performance categories are not effective until next year, we are issuing an interim final rule for automatic extreme and uncontrollable circumstances where clinicians can be exempt form these categories in the transition year without submitting a hardship exception application,” CMS noted in the fact sheet. For 2017, that means clinicians in areas affected by the hurricanes who do not submit data will not receive any negative adjustment, Clinicians who do submit data will be scored as usual.
On the advanced APM track, under which physicians take on more risk in exchange for a potential for greater bonus payments, CMS said it is making it easier for clinicians to participate, including extending certain revenue and expenditure provisions for an additional 2 years that are used to determine nominal risk, changing the medical home models to slower the increase of the minimal amount of financial risk taken on, and making it easier for clinicians to earn bonus payments for APMs that begin or end mid-year.
The final rule is scheduled for publication in the Federal Register on Nov. 16.
More doctors will be exempt from participation in the Merit-Based Incentive Payment System in 2018, under a final rule issued by the Health & Human Service department.
The final rule excludes from MIPS participation any health care providers who are part of an advanced alternative payment model (APM), those who have $90,000 or less in Medicare Part B billings or who see 200 or fewer Medicare patients. For the 2017 reporting year, those levels were $30,000 and 100 patients.
In comments when the rule was a draft, many organizations suggested that CMS allow clinicians who are ready to participate in MIPS to opt in even if they fall into the MIPS low-volume threshold category. While the agency did not codify this suggestion, officials noted that they intend “revisit this policy in future rule making and are seeking comment on methods to implement this policy in a low-burden manner.”
Medical societies were generally in favor of the new higher threshold, but it was met with resistance from associations representing group practices.
“The transition to value is challenging and CMS understandably want to ease providers into value,” Jerry Penso, MD, president and CEO of the American Medical Group Association said in a statement. “But excluding providers isn’t the same as learning how to deliver care in a value-based world. Taking accountability for the quality and cost of care requires years of experience. Despite CMS’ intentions to ensure a smooth transition, AMGA is concerned that this rule actually hinders the prospects for value-based care.”
CMS is providing a number of enhancements for small practices participating in MIPS.
Small practices (15 or fewer providers) will get five bonus points under MIPS and will continue to earn points for partial data reporting of quality measures. They also will be able to join virtual groups to help aggregate their reporting and improve abilities to access payment bonuses. (Find a link to download a virtual group toolkit on page 4 of the CMS fact sheet for the final rule.)
CMS also is slowly phasing into the cost performance category, which will account for 10% of a MIPS score and will include Medicare spending per beneficiary and total per capita cost measures. These measures are carried over from the Value Modifier program and will require no action from providers to calculate. CMS will measure the performance in this category.
Finally, the agency included a hardship exemption for those affected by major hurricanes in the Gulf Coast and Puerto Rico in 2017. Currently, those who lost access to their EHRs because of the hurricanes, other natural disasters, or public health emergencies, they can file a hardship exemption to have their Advancing Care Information (formerly the meaningful use program) score reweighted to reflect the issues. Applications must be filed by Dec. 31, 2017. The final rule extends the reweighting policy to the other three categories (quality, cost, and improvement activities) through the 2018 performance year, with a deadline of Dec. 31, 2018, to file for a hardship exemption.
“Because our policies relating to reweighting the quality, cost, and improvement activities performance categories are not effective until next year, we are issuing an interim final rule for automatic extreme and uncontrollable circumstances where clinicians can be exempt form these categories in the transition year without submitting a hardship exception application,” CMS noted in the fact sheet. For 2017, that means clinicians in areas affected by the hurricanes who do not submit data will not receive any negative adjustment, Clinicians who do submit data will be scored as usual.
On the advanced APM track, under which physicians take on more risk in exchange for a potential for greater bonus payments, CMS said it is making it easier for clinicians to participate, including extending certain revenue and expenditure provisions for an additional 2 years that are used to determine nominal risk, changing the medical home models to slower the increase of the minimal amount of financial risk taken on, and making it easier for clinicians to earn bonus payments for APMs that begin or end mid-year.
The final rule is scheduled for publication in the Federal Register on Nov. 16.
Why VADS is gaining ground in pediatrics
The miniaturization of continuous-flow ventricular assist devices has launched the era of continuous-flow VAD support in pediatric patients, and the trend may accelerate with the introduction of a continuous-flow device designed specifically for small children. In an expert opinion in the Journal of Thoracic and Cardiovascular Surgery, Iki Adachi, MD, of Baylor College of Medicine in Houston, said the emerging science of continuous-flow VADs in children promises to solve problems like device size mismatch, hospital-only VADs, and chronic therapy (J Thorac Cardiovasc Surg. 2017 Oct;154:1358-61). “With ongoing device miniaturization, enthusiasm has been growing among pediatric physicians for the use of continuous-flow VADs in children,” Dr. Adachi said. He noted the introduction of a continuous-flow device for small children, the Infant Jarvik 2015, “may further accelerate the trend.”
Dr. Adachi cited PediMACS reports that stated that more than half of the long-term devices now registered are continuous-flow devices, and that continuous-flow VADs comprised 62% of all durable VAD implants in the third quarter of 2016. “With the encouraging results recorded to date, the use of continuous-flow devices in the pediatric population is rapidly increasing,” he said.
Miniaturization has addressed the problem of size mismatch when using continuous-flow VAD devices in children, he said, noting that use of the Infant Jarvik device may be expanded even further to children as small at 8 kg or less. The PumpKIN trial(Pumps for Kids, Infants, and Neonates), which is evaluating the Infant Jarvik 2015 vs. the Berlin Heart EXCOR, could provide answers on the feasibility of continuous-flow VADs in small children.
“Based on experience with the chronic animal model, I believe that the Infant Jarvik device will properly fit the patients included in the trial,” he said.
Continuous-flow VAD in children also holds potential for managing these patients outside the hospital setting. “Outpatient management of children with continuous-flow VADs has been shown to be feasible,” he said, adding that the PediMACS registry has reported that only 45% of patients have been managed this way. “Nonetheless, with maturation of the pediatric field, outpatient management will become routine rather than the exception,” he said.
Greater use of continuous-flow VADs also may create opportunities to improve the status and suitability for transplantation of children with severe heart failure, he said. He gave as an example his group’s practice at Houston’s Texas Children’s Hospital, which is to deactivate patients on the transplant wait list for 3 months once they start continuous-flow VAD support. “A postoperative ‘grace period’ affords protected opportunities for both physical and psychological recovery,” he said. This timeout of sorts also affords the care team time to assess the myocardium for possible functional recovery.
In patients who are not good candidates for transplantation, durable continuous-flow VADs may provide chronic therapy, and in time, these patients may become suitable transplant candidates, said Dr. Adachi. “Bypassing such an unfavorable period for transplantation with prolonged VAD support may be a reasonable approach,” he said.
Patients with failing single-ventricle circulation also may benefit from VAD support, although the challenges facing this population are more profound than in other groups, Dr. Adachi said. VAD support for single-ventricle disease is sparse, but these patients require careful evaluation of the nature of their condition. “If systolic dysfunction is the predominant cause of circulatory failure, then VAD support for the failing systemic ventricle will likely improve hemodynamics,” said Dr. Adachi. VAD support also could help the patient move through the various stages of palliation.
“Again, the emphasis is not just on simply keeping the patient alive until a donor organ becomes available; rather, attention is refocused on overall health beyond survival, which may eventually affect transplantation candidacy and even post transplantation outcome,” Dr. Adachi concluded.
Dr. Adachi serves as a consultant and proctor for Berlin Heart and HeartWare, and as a consultant for the New England Research Institute related to the PumpKIN trial.
The miniaturization of continuous-flow ventricular assist devices has launched the era of continuous-flow VAD support in pediatric patients, and the trend may accelerate with the introduction of a continuous-flow device designed specifically for small children. In an expert opinion in the Journal of Thoracic and Cardiovascular Surgery, Iki Adachi, MD, of Baylor College of Medicine in Houston, said the emerging science of continuous-flow VADs in children promises to solve problems like device size mismatch, hospital-only VADs, and chronic therapy (J Thorac Cardiovasc Surg. 2017 Oct;154:1358-61). “With ongoing device miniaturization, enthusiasm has been growing among pediatric physicians for the use of continuous-flow VADs in children,” Dr. Adachi said. He noted the introduction of a continuous-flow device for small children, the Infant Jarvik 2015, “may further accelerate the trend.”
Dr. Adachi cited PediMACS reports that stated that more than half of the long-term devices now registered are continuous-flow devices, and that continuous-flow VADs comprised 62% of all durable VAD implants in the third quarter of 2016. “With the encouraging results recorded to date, the use of continuous-flow devices in the pediatric population is rapidly increasing,” he said.
Miniaturization has addressed the problem of size mismatch when using continuous-flow VAD devices in children, he said, noting that use of the Infant Jarvik device may be expanded even further to children as small at 8 kg or less. The PumpKIN trial(Pumps for Kids, Infants, and Neonates), which is evaluating the Infant Jarvik 2015 vs. the Berlin Heart EXCOR, could provide answers on the feasibility of continuous-flow VADs in small children.
“Based on experience with the chronic animal model, I believe that the Infant Jarvik device will properly fit the patients included in the trial,” he said.
Continuous-flow VAD in children also holds potential for managing these patients outside the hospital setting. “Outpatient management of children with continuous-flow VADs has been shown to be feasible,” he said, adding that the PediMACS registry has reported that only 45% of patients have been managed this way. “Nonetheless, with maturation of the pediatric field, outpatient management will become routine rather than the exception,” he said.
Greater use of continuous-flow VADs also may create opportunities to improve the status and suitability for transplantation of children with severe heart failure, he said. He gave as an example his group’s practice at Houston’s Texas Children’s Hospital, which is to deactivate patients on the transplant wait list for 3 months once they start continuous-flow VAD support. “A postoperative ‘grace period’ affords protected opportunities for both physical and psychological recovery,” he said. This timeout of sorts also affords the care team time to assess the myocardium for possible functional recovery.
In patients who are not good candidates for transplantation, durable continuous-flow VADs may provide chronic therapy, and in time, these patients may become suitable transplant candidates, said Dr. Adachi. “Bypassing such an unfavorable period for transplantation with prolonged VAD support may be a reasonable approach,” he said.
Patients with failing single-ventricle circulation also may benefit from VAD support, although the challenges facing this population are more profound than in other groups, Dr. Adachi said. VAD support for single-ventricle disease is sparse, but these patients require careful evaluation of the nature of their condition. “If systolic dysfunction is the predominant cause of circulatory failure, then VAD support for the failing systemic ventricle will likely improve hemodynamics,” said Dr. Adachi. VAD support also could help the patient move through the various stages of palliation.
“Again, the emphasis is not just on simply keeping the patient alive until a donor organ becomes available; rather, attention is refocused on overall health beyond survival, which may eventually affect transplantation candidacy and even post transplantation outcome,” Dr. Adachi concluded.
Dr. Adachi serves as a consultant and proctor for Berlin Heart and HeartWare, and as a consultant for the New England Research Institute related to the PumpKIN trial.
The miniaturization of continuous-flow ventricular assist devices has launched the era of continuous-flow VAD support in pediatric patients, and the trend may accelerate with the introduction of a continuous-flow device designed specifically for small children. In an expert opinion in the Journal of Thoracic and Cardiovascular Surgery, Iki Adachi, MD, of Baylor College of Medicine in Houston, said the emerging science of continuous-flow VADs in children promises to solve problems like device size mismatch, hospital-only VADs, and chronic therapy (J Thorac Cardiovasc Surg. 2017 Oct;154:1358-61). “With ongoing device miniaturization, enthusiasm has been growing among pediatric physicians for the use of continuous-flow VADs in children,” Dr. Adachi said. He noted the introduction of a continuous-flow device for small children, the Infant Jarvik 2015, “may further accelerate the trend.”
Dr. Adachi cited PediMACS reports that stated that more than half of the long-term devices now registered are continuous-flow devices, and that continuous-flow VADs comprised 62% of all durable VAD implants in the third quarter of 2016. “With the encouraging results recorded to date, the use of continuous-flow devices in the pediatric population is rapidly increasing,” he said.
Miniaturization has addressed the problem of size mismatch when using continuous-flow VAD devices in children, he said, noting that use of the Infant Jarvik device may be expanded even further to children as small at 8 kg or less. The PumpKIN trial(Pumps for Kids, Infants, and Neonates), which is evaluating the Infant Jarvik 2015 vs. the Berlin Heart EXCOR, could provide answers on the feasibility of continuous-flow VADs in small children.
“Based on experience with the chronic animal model, I believe that the Infant Jarvik device will properly fit the patients included in the trial,” he said.
Continuous-flow VAD in children also holds potential for managing these patients outside the hospital setting. “Outpatient management of children with continuous-flow VADs has been shown to be feasible,” he said, adding that the PediMACS registry has reported that only 45% of patients have been managed this way. “Nonetheless, with maturation of the pediatric field, outpatient management will become routine rather than the exception,” he said.
Greater use of continuous-flow VADs also may create opportunities to improve the status and suitability for transplantation of children with severe heart failure, he said. He gave as an example his group’s practice at Houston’s Texas Children’s Hospital, which is to deactivate patients on the transplant wait list for 3 months once they start continuous-flow VAD support. “A postoperative ‘grace period’ affords protected opportunities for both physical and psychological recovery,” he said. This timeout of sorts also affords the care team time to assess the myocardium for possible functional recovery.
In patients who are not good candidates for transplantation, durable continuous-flow VADs may provide chronic therapy, and in time, these patients may become suitable transplant candidates, said Dr. Adachi. “Bypassing such an unfavorable period for transplantation with prolonged VAD support may be a reasonable approach,” he said.
Patients with failing single-ventricle circulation also may benefit from VAD support, although the challenges facing this population are more profound than in other groups, Dr. Adachi said. VAD support for single-ventricle disease is sparse, but these patients require careful evaluation of the nature of their condition. “If systolic dysfunction is the predominant cause of circulatory failure, then VAD support for the failing systemic ventricle will likely improve hemodynamics,” said Dr. Adachi. VAD support also could help the patient move through the various stages of palliation.
“Again, the emphasis is not just on simply keeping the patient alive until a donor organ becomes available; rather, attention is refocused on overall health beyond survival, which may eventually affect transplantation candidacy and even post transplantation outcome,” Dr. Adachi concluded.
Dr. Adachi serves as a consultant and proctor for Berlin Heart and HeartWare, and as a consultant for the New England Research Institute related to the PumpKIN trial.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Advances in continuous-flow ventricular assist devices (VADs) promise a paradigm shift in pediatrics.
Major finding: Device miniaturization is solving problems such as size mismatch, inpatients on VADs, and chronic therapy.
Data source: Expert opinion drawing on PediMACS reports and published trials of continuous-flow VAD.
Disclosures: Dr. Adachi serves as a consultant and proctor for Berlin Heart and HeartWare and as a consultant for the New England Research Institute related to the PumpKIN trial.
Challenges of validating cerebral protection for TAVI
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
Dr. Messé and Dr. Furie pointed out the difficulty of quantifying the incidence of stroke during TAVI. But the long-term impact of stroke is more important because TAVI, as opposed to surgical aortic valve replacement, is more likely to be performed in a younger, healthier population, John Bozinovski, MD, of the University of British Columbia in Victoria said in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:484-5).
While Dr. Messé and Dr. Furie make a valid point that clinically significant stroke, as opposed to diagnostically apparent stroke, is an important outcome of trials of embolic protection in TAVI, the long-term impact of silent strokes identified only with neuroimaging is unknown, “As such, ‘clinically significant’ stroke carries a nebulous definition,” Dr. Bozinovski said.
Nonetheless, CEP devices may become standard “even without good evidence” to support their use, Dr. Bozinovski said, “or perhaps they will be used infrequently or not at all.” Their uptake by cardiac surgeons will depend on the supporting evidence and their treatment effect. “Not only is it difficult to design an effective device, it is possible that we may not know whether a device is effective or what is the size of that effect,” he said. As Dr. Messé and Dr. Furie point out, “Designing and successfully conducting the trial to do so might never occur.”
Dr. Bozinovski disclosed he was a paid consultant with Edwards Life Sciences.
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
While using cerebral embolic protection during transcatheter aortic valve implantation (TAVI) seems appealing to reduce the risk of stroke, which has been reported to be higher than in open aortic valve replacement, the challenge of developing practical CEP devices and then designing appropriate trials may be insurmountable, according to a featured expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154;880-3).
Dr. Messé and Dr. Furie reviewed completed trials of five different CEP devices in 630 patients, noting that the trials confirmed the difficulty of “designing a trial that can prove a clinical benefit.” They noted 30-day stroke rates ranged from 4% to 6.7%, although prospective, nonrandomized European registries reported rates of 3.4% to 4.1%, and a large U.S. registry reported a rate of 2.5%. These results suggest “that some neurologic complications are going undetected or underreported in routine clinical practice.”
That may be a function of the different methods the trials used to determine complications. “There are little data to define best practice, but direct comprehensive assessment by a neurologist is likely the most accurate and sensitive method for detecting clinical stroke,” they added.
Another important factor is the timing of the assessment. They pointed out that half of all 30-day stroke events in TAVI are detected within 2 days of the procedure, but mild or transient symptoms can be missed if the only evaluation occurs just before discharge. “Unfortunately, in most studies this is when the neurologic assessment is performed,” Dr. Messé and Dr. Furie wrote. They added that long-term effects of these strokes have not been well studied.
What’s more, many TAVI patients have subclinical ischemic injury that only neuroimaging can detect. “Studies of MRI performed early after TAVI have demonstrated acute infarcts in 68% to 97% of patients,” the stated. While small and multiple, these microinfarcts may not be totally silent. “Additional studies to assess the long-term implications of clinically silent infarcts are clearly needed,” the coauthors said.
They also noted that a trial of stenting vs. endarterectomy for carotid stenosis raises caution about CEP devices (Lancet Neurol. 2010;9:353-62), as patients who had angioplasty and stenting and were treated with a CEP device had higher rates of acute infarct detected on MRI than those who did not have the CEP. Placing the CEP device through a severely stenosed and symptomatic carotid artery may have led to additional cerebral emboli.
“Placing a cerebral protection device in the aorta for a TAVI procedure also could be problematic in the presence of severe aortic arch disease or variant anatomy,” Dr. Messé and Dr. Furie commented. With two large trials of embolic protection in TAVI currently underway, the coauthors said, “the field eagerly awaits these results.”
Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the National Institutes of Health/National Heart, Lung, and Blood Institute/National Institute of Neurologic Disorders and Stroke–sponsored Cardiothoracic Surgery Network.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Cerebral embolic protection during TAVI is an appealing concept that faces challenges.
Major finding: Developing practical and safe devices and testing them in adequately powered trials are daunting tasks.
Data source: Review of five completed and two ongoing clinical trials of 603 and 613 patients, respectively.
Disclosures: Dr. Messé has received research support from GlaxoSmithKline and Direct Flow Medical. Both Dr. Messé and Dr. Furie have participated in the NIH/NHLBI/NINDS-sponsored Cardiothoracic Surgery Network.
Strict OR attire policy had no impact on SSI rate
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
SAN DIEGO – Implementation of strict operating room (OR) attire policies did not reduce the rates of superficial surgical site infections (SSIs), according to an analysis of more than 6,500 patients.
“SSIs are the most common cause of health care–associated infections in the U.S.,” study author Sandra Farach, MD, said at the annual clinical congress of the American College of Surgeons. “It’s estimated that SSIs occur in 2%-5% of patients undergoing inpatient surgery. They’re associated with significant patient morbidity and mortality and are a significant burden to the health care system, accounting for an estimated $3.5 to $10 billion in health care expenditures.”
In February 2015, the Association for periOperative Registered Nurses published recommendations on operating room attire, providing a guideline for modifying facility policies and regulatory requirements. It included stringent policies designed to minimize the exposed areas of skin and hair of operating room staff. “New attire policies were met with some criticism as there is a paucity of evidence-based data to support these recommendations,” said Dr. Farach, who helped conduct the study during her tenure as chief resident of general surgery at the University of Rochester (N.Y.) Medical Center.
A total of 6,517 patients were included in the analysis: 3,077 in the preimplementation group and 3,440 patients in the postimplementation group. The postimplementation group tended to be older and had significantly higher rates of hypertension, dialysis treatments, steroid use, and systemic inflammatory response syndrome, as well as higher American Society of Anesthesiologists classification scores. “However, they had a significantly lower BMI, incidence of smoking and COPD, and a higher incidence of clean wounds, which would theoretically leave them less exposed to SSIs,” said Dr. Farach, who is now a pediatric surgical critical care fellow at Le Bonheur Children’s Hospital in Memphis.
Overall, the rate of SSIs by wound class increased between the preimplementation and postimplementation time periods: The percent of change was 0.6%, 0.9%, 2.3%, and 3.8% in the clean, clean-contaminated, contaminated, and dirty/infected cases, respectively. When the review was limited to clean or clean-contaminated cases, SSI increased slightly, from 0.7% to 0.8% (P = .085). There were no significant differences in the complication rate, 30-day mortality, unplanned return to the OR, or length of stay between preimplementation or postimplementation at either hospital.
When Dr. Farach and her associates examined the overall infection rate, they observed no significant differences preimplementation and postimplementation in the rates of incisional SSI (0.97% vs. 0.96%, respectively; P = .949), organ space SSI (1.20% vs. 0.81%; P = .115), and total SSIs (2.11% vs. 1.77%; P = .321). Multivariate analysis showed that implementation of OR changes was not associated with an increased risk of SSIs. Factors that did predict high SSI rates included preoperative SSI (adjusted odds ratio 23.04), long operative time (AOR 3.4), preoperative open wound (AOR 2.94), contaminated/dirty wound classes (AOR 2.32), and morbid obesity (AOR 1.8).
“A hypothetical analysis revealed that a sample of over 495,000 patients would be required to demonstrate a 10% incisional SSI reduction among patients with clean or clean-contaminated wounds,” Dr. Farach noted. “Nevertheless, the study showed a numerical increase in SSI during the study period. Policies regarding OR attire were universally unpopular. As a result, OR governance is now working to repeal these new policies at both hospitals.”
“Given the rarity of SSI in the population subset which is relevant to the OR attire question (clean and clean-contaminated wounds, 0.7%), designing a study to prove effectiveness of an intervention (i.e., a 10% improvement) is totally impractical to conduct as this would require nearly a half a million cases,” said Jacob Moalem, MD, the lead author of the study who is an endocrine surgeon at the University of Rochester. At the meeting, a discussant suggested that conducting such a study is feasible; however, “I would strongly argue that putting that many people through such a study, when we know that these attire rules have a deleterious effect on surgeon comfort and OR team dynamics and morale, would not be prudent,” Dr. Moalem said. “We know that surgeon comfort, ability to focus on the task at hand, and minimizing distractions in the OR are critically important in reducing errors. In my opinion, by continuing to focus on these unfounded attire restrictions, one would be far more likely to actually cause injury to a patient than to prevent a wound infection.”
The researchers reported having no financial disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Implementation of stringent operating room attire policies do not reduce rates superficial surgical site infections (SSIs).
Major finding: The researchers observed no significant differences preimplementation and postimplementation of OR attire policies in the rates of incisional SSI (0.97 vs. 0.96, respectively; P = .949), organ space SSI (1.20 vs 0.81; P = .115), and total SSIs (2.11 vs. 1.77; P = .321).
Study details: A study of 6,517 patients who underwent surgery at two tertiary care teaching hospitals.
Disclosures: The researchers reported having no financial disclosures.
Weight recidivism after bariatric surgery: What constitutes failure?
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
NATIONAL HARBOR, MD. – A standard definition of bariatric surgery failure based on weight regain is needed to assess long-term outcomes in place of the seemingly arbitrary thresholds now in use, according to discussion generated by long-term outcome studies presented at Obesity Week 2017.
In another study, presented by Colin Martyn, MD, a general surgery resident at Texas Tech University Health Sciences Center, El Paso, the bariatric surgery failure rate at 11 years was characterized as an “alarming” 33.9%. In this study, bariatric surgery was considered a failure if the patient did not maintain excess weight loss (EWL) of 50% or greater.
The problem with this definition, like many others, is that “it fails to recognize that there could be significant health benefits and improvements in quality of life with less weight loss,” according to Philip Schauer, MD, director of the Cleveland Clinic Bariatric and Metabolic Institute. As the invited discussant for the data presented by Dr. Martyn, Dr. Schauer acknowledged that 50% EWL has been used by others as the dividing line between success and failure, but he called it “obsolete.”
This definition was one of several applied to weight recidivism in the study presented by Dr. Morell. Others included weight regain of more than 25% EWL over the postoperative nadir, an increase in body mass index to more than 35 kg/m2 after achieving a lower BMI, and a postsurgical BMI increase of more than 5 mg/m2. Not surprisingly, weight recidivism “varied widely with regard to the definitions used,” Dr. Morell reported.
Dr. Morell’s study involved evaluation of 1,766 patients with at least 1 year of follow-up after bariatric procedure. Most (1,490 patients) underwent laparoscopic Roux-en-y gastric bypass. After 2 years of follow-up, 93% achieved at least the 50% EWL threshold of treatment success, but Dr. Morell reported that the proportion above this or any threshold progressively diminished over time. For a definition of treatment success, Dr. Morell favors maintenance of at least 20% total weight loss as a threshold of long-term clinical success, a threshold met by 75% of patients at 5 years, in his analysis.
As has been shown in these studies and reported previously, the regaining of weight over time after bariatric surgery is common and progressive, but both studies ignited controversy about what measure is meaningful for declaring that bariatric surgery has failed over the long term. None of the current thresholds for failure are based on evidence that clinical benefit has been lost. Rather, it appears that these are simply accepted conventions.
“It bothers me to hear the word failure in these presentations, because I think the paradigm is changing from success and failure to that of treating chronic disease,” said Stacy Brethauer, MD, a staff surgeon in the Cleveland Clinic Digestive Disease Institute. Dr. Brethauer, the moderator of the session at Obesity Week where both long-term follow-up papers were presented, agreed that the at least 50% EWL benchmark is “flawed.” He suggested that more clinically meaningful methods of evaluating long-term outcome are needed for both clinical and research purposes.
The discussant of Dr. Morell’s paper, Samer G. Mattar, MD, a bariatric surgeon at the Swedish Medical Center, Seattle, also called for metrics based on clinical benefit rather than on weight alone.
“I would caution against this overall emphasis that we seem to place on weight gain and weight loss as a benchmark and predominant objective for what we do,” he said. “Our nonsurgeon colleagues have repeatedly demonstrated clinical benefits from total body weight loss of 10% or even 5%. So let’s not beat up ourselves over trying to maintain a greater than 50% EWL in all our patients.”
AT OBESITY WEEK 2017
Key clinical point: Many patients regain weight after bariatric surgery, but experts argue over the definition of long-term treatment failure, for which there is no standard.
Major finding: After 5 or more years of follow-up, failure rates range from 25% to 70% depending on definition of unacceptable weight regain.
Data source: A retrospective review.
Disclosures: Dr. Morell and Dr. Martyn reported no financial relationships relevant to this topic.
Transition to Practice Program Accepting 2018–2019 Applications
Institutions participating in the American College of Surgeons (ACS) Transition to Practice (TTP) Program are now accepting applications for TTP Associates for the 2018−2019 academic year. Interested residents are encouraged to review the program profiles on the ACS website and submit an application to [email protected].
In addition, the TTP Steering Committee is accepting applications from institutions interested in establishing a new TTP Program site. Contact [email protected] for more information on the application process.
The ACS Division of Education launched the TTP Program in 2013 in response to the identified need for autonomous experience for general surgeons leaving residency. The program adds a layer of expertise between residency and independent practice. TTP Associates experience increasing autonomy throughout the year in a broad-based clinical setting, build their competence and confidence in general surgery, develop practice management skills, and gain practical experience for the next phase of their careers. Working closely with experienced surgeons, TTP Associates concentrate on specific areas within general surgery to refine operative skills based on their career goals.
Institutions participating in the American College of Surgeons (ACS) Transition to Practice (TTP) Program are now accepting applications for TTP Associates for the 2018−2019 academic year. Interested residents are encouraged to review the program profiles on the ACS website and submit an application to [email protected].
In addition, the TTP Steering Committee is accepting applications from institutions interested in establishing a new TTP Program site. Contact [email protected] for more information on the application process.
The ACS Division of Education launched the TTP Program in 2013 in response to the identified need for autonomous experience for general surgeons leaving residency. The program adds a layer of expertise between residency and independent practice. TTP Associates experience increasing autonomy throughout the year in a broad-based clinical setting, build their competence and confidence in general surgery, develop practice management skills, and gain practical experience for the next phase of their careers. Working closely with experienced surgeons, TTP Associates concentrate on specific areas within general surgery to refine operative skills based on their career goals.
Institutions participating in the American College of Surgeons (ACS) Transition to Practice (TTP) Program are now accepting applications for TTP Associates for the 2018−2019 academic year. Interested residents are encouraged to review the program profiles on the ACS website and submit an application to [email protected].
In addition, the TTP Steering Committee is accepting applications from institutions interested in establishing a new TTP Program site. Contact [email protected] for more information on the application process.
The ACS Division of Education launched the TTP Program in 2013 in response to the identified need for autonomous experience for general surgeons leaving residency. The program adds a layer of expertise between residency and independent practice. TTP Associates experience increasing autonomy throughout the year in a broad-based clinical setting, build their competence and confidence in general surgery, develop practice management skills, and gain practical experience for the next phase of their careers. Working closely with experienced surgeons, TTP Associates concentrate on specific areas within general surgery to refine operative skills based on their career goals.
From the Washington Office: Taking action
As we head into the last few weeks of the first session of the 115th Congress, it is likely that several pieces of “must pass” legislation will move through the process of becoming law. This “must pass” legislation can serve as a vehicle onto which other bills are attached and thus, also move successfully through the process for passage. I have highlighted below three such bills from the Action Alert section of the SurgeonsVoice website (www.surgeonsvoice.com) which could, with less than 5 minutes of your time, develop enough forward momentum to so move.
Ensuring Access to General Surgery Act
Increasing evidence indicates a current and growing shortage of surgeons available to serve our nation’s population. A shortage of general surgeons is a critical component of the crisis in health care workforce because only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize, through the designation of a formal surgical shortage area, that surgeons are an essential component of a community based health care system.
Unlike other key providers of the community-based health care system, general surgeons do not currently have a formal workforce shortage area designation. In light of growing evidence demonstrating a shortage of general surgeons, ACS believes that more accurate and actionable workforce data are necessary to determine exactly what constitutes a surgical shortage area for general surgery, and where these areas exist. Identifying where patients lack access to surgical services will provide HRSA with a valuable new tool for increasing access to the full spectrum of high-quality health care services. Determining what constitutes and defines a surgical shortage area is an important first step in guaranteeing all Medicare beneficiaries, regardless of geographic location, have access to quality surgical care.
Mission Zero Act
It has long been a priority of the ACS to establish and maintain high-quality and adequately-funded trauma systems throughout the U.S., including within the Armed Forces. The Mission Zero Act, introduced by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Gene Green (D-TX), Richard Hudson (R-NC), and Kathy Castor (D-FL) in the House of Representatives and Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL) in the Senate, would provide HHS grant funding to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality trauma care. As a result of these partnerships, military trauma care teams and providers will gain exposure treating critically injured patients and increase readiness for future deployments. Not only will this serve to maintain readiness among military providers, but it will facilitate the promulgation of the trauma lessons learned from the military theatres of conflict to the civilian world and potentially alleviate staffing shortages in civilian centers.
CHIP Funding
The Children’s Health Insurance Program (CHIP) is a joint federal and state program that provides health coverage to uninsured children from low-income families. In 2015, the CHIP program provided coverage to over 8 million children in the United States. In sum, CHIP ensures that these children have access to care. The ACS is very supportive of the CHIP program. The CHIP program ensures that a child’s health care concerns are addressed in a timely manner. Contrary to popular belief, many children currently covered by CHIP are not eligible to be covered under Medicaid and would therefore, be left uninsured if CHIP funding is not continued. The most recent reauthorization of this program extended funding for the CHIP program through Sept. 30, 2017, and funding for the program expired on that date. Urgent Congressional action is needed to reauthorize funding and thus, ensure that the children covered by CHIP continue to have access to the health care services they need.
The ACS strongly urges Congress to continue to make children’s health care a priority issue and accordingly, implores Congress to take action to reauthorize CHIP funding prior to concluding the business of the current session.
The SurgeonsVoice website provides an easy and efficient platform for surgeons to use to contact their senators and their representative to let them know of their support of these issues. Taking action on all three of these items would require the investment of less than 5 minutes of one’s valuable time. Our ability “to petition the government for a redress of grievances” is guaranteed by the First Amendment. I urge all Fellows to visit the SurgeonsVoice website and use it as a tool to exercise that right.
Until next month ….
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
As we head into the last few weeks of the first session of the 115th Congress, it is likely that several pieces of “must pass” legislation will move through the process of becoming law. This “must pass” legislation can serve as a vehicle onto which other bills are attached and thus, also move successfully through the process for passage. I have highlighted below three such bills from the Action Alert section of the SurgeonsVoice website (www.surgeonsvoice.com) which could, with less than 5 minutes of your time, develop enough forward momentum to so move.
Ensuring Access to General Surgery Act
Increasing evidence indicates a current and growing shortage of surgeons available to serve our nation’s population. A shortage of general surgeons is a critical component of the crisis in health care workforce because only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize, through the designation of a formal surgical shortage area, that surgeons are an essential component of a community based health care system.
Unlike other key providers of the community-based health care system, general surgeons do not currently have a formal workforce shortage area designation. In light of growing evidence demonstrating a shortage of general surgeons, ACS believes that more accurate and actionable workforce data are necessary to determine exactly what constitutes a surgical shortage area for general surgery, and where these areas exist. Identifying where patients lack access to surgical services will provide HRSA with a valuable new tool for increasing access to the full spectrum of high-quality health care services. Determining what constitutes and defines a surgical shortage area is an important first step in guaranteeing all Medicare beneficiaries, regardless of geographic location, have access to quality surgical care.
Mission Zero Act
It has long been a priority of the ACS to establish and maintain high-quality and adequately-funded trauma systems throughout the U.S., including within the Armed Forces. The Mission Zero Act, introduced by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Gene Green (D-TX), Richard Hudson (R-NC), and Kathy Castor (D-FL) in the House of Representatives and Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL) in the Senate, would provide HHS grant funding to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality trauma care. As a result of these partnerships, military trauma care teams and providers will gain exposure treating critically injured patients and increase readiness for future deployments. Not only will this serve to maintain readiness among military providers, but it will facilitate the promulgation of the trauma lessons learned from the military theatres of conflict to the civilian world and potentially alleviate staffing shortages in civilian centers.
CHIP Funding
The Children’s Health Insurance Program (CHIP) is a joint federal and state program that provides health coverage to uninsured children from low-income families. In 2015, the CHIP program provided coverage to over 8 million children in the United States. In sum, CHIP ensures that these children have access to care. The ACS is very supportive of the CHIP program. The CHIP program ensures that a child’s health care concerns are addressed in a timely manner. Contrary to popular belief, many children currently covered by CHIP are not eligible to be covered under Medicaid and would therefore, be left uninsured if CHIP funding is not continued. The most recent reauthorization of this program extended funding for the CHIP program through Sept. 30, 2017, and funding for the program expired on that date. Urgent Congressional action is needed to reauthorize funding and thus, ensure that the children covered by CHIP continue to have access to the health care services they need.
The ACS strongly urges Congress to continue to make children’s health care a priority issue and accordingly, implores Congress to take action to reauthorize CHIP funding prior to concluding the business of the current session.
The SurgeonsVoice website provides an easy and efficient platform for surgeons to use to contact their senators and their representative to let them know of their support of these issues. Taking action on all three of these items would require the investment of less than 5 minutes of one’s valuable time. Our ability “to petition the government for a redress of grievances” is guaranteed by the First Amendment. I urge all Fellows to visit the SurgeonsVoice website and use it as a tool to exercise that right.
Until next month ….
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
As we head into the last few weeks of the first session of the 115th Congress, it is likely that several pieces of “must pass” legislation will move through the process of becoming law. This “must pass” legislation can serve as a vehicle onto which other bills are attached and thus, also move successfully through the process for passage. I have highlighted below three such bills from the Action Alert section of the SurgeonsVoice website (www.surgeonsvoice.com) which could, with less than 5 minutes of your time, develop enough forward momentum to so move.
Ensuring Access to General Surgery Act
Increasing evidence indicates a current and growing shortage of surgeons available to serve our nation’s population. A shortage of general surgeons is a critical component of the crisis in health care workforce because only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Accordingly, the American College of Surgeons (ACS) is urging policy makers to recognize, through the designation of a formal surgical shortage area, that surgeons are an essential component of a community based health care system.
Unlike other key providers of the community-based health care system, general surgeons do not currently have a formal workforce shortage area designation. In light of growing evidence demonstrating a shortage of general surgeons, ACS believes that more accurate and actionable workforce data are necessary to determine exactly what constitutes a surgical shortage area for general surgery, and where these areas exist. Identifying where patients lack access to surgical services will provide HRSA with a valuable new tool for increasing access to the full spectrum of high-quality health care services. Determining what constitutes and defines a surgical shortage area is an important first step in guaranteeing all Medicare beneficiaries, regardless of geographic location, have access to quality surgical care.
Mission Zero Act
It has long been a priority of the ACS to establish and maintain high-quality and adequately-funded trauma systems throughout the U.S., including within the Armed Forces. The Mission Zero Act, introduced by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Gene Green (D-TX), Richard Hudson (R-NC), and Kathy Castor (D-FL) in the House of Representatives and Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL) in the Senate, would provide HHS grant funding to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality trauma care. As a result of these partnerships, military trauma care teams and providers will gain exposure treating critically injured patients and increase readiness for future deployments. Not only will this serve to maintain readiness among military providers, but it will facilitate the promulgation of the trauma lessons learned from the military theatres of conflict to the civilian world and potentially alleviate staffing shortages in civilian centers.
CHIP Funding
The Children’s Health Insurance Program (CHIP) is a joint federal and state program that provides health coverage to uninsured children from low-income families. In 2015, the CHIP program provided coverage to over 8 million children in the United States. In sum, CHIP ensures that these children have access to care. The ACS is very supportive of the CHIP program. The CHIP program ensures that a child’s health care concerns are addressed in a timely manner. Contrary to popular belief, many children currently covered by CHIP are not eligible to be covered under Medicaid and would therefore, be left uninsured if CHIP funding is not continued. The most recent reauthorization of this program extended funding for the CHIP program through Sept. 30, 2017, and funding for the program expired on that date. Urgent Congressional action is needed to reauthorize funding and thus, ensure that the children covered by CHIP continue to have access to the health care services they need.
The ACS strongly urges Congress to continue to make children’s health care a priority issue and accordingly, implores Congress to take action to reauthorize CHIP funding prior to concluding the business of the current session.
The SurgeonsVoice website provides an easy and efficient platform for surgeons to use to contact their senators and their representative to let them know of their support of these issues. Taking action on all three of these items would require the investment of less than 5 minutes of one’s valuable time. Our ability “to petition the government for a redress of grievances” is guaranteed by the First Amendment. I urge all Fellows to visit the SurgeonsVoice website and use it as a tool to exercise that right.
Until next month ….
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
FDA: Ultrasound surgical devices are contraindicated for uterine fibroid removal
, according to the Food and Drug Administration.
These devices have the potential to disseminate undetected tumor tissue, and there are no proven preoperative screening methods for detecting uterine sarcoma in uterine fibroids that otherwise appear to be benign, FDA officials wrote in a guidance document issued Oct. 30. The FDA is calling for new product labeling for these devices within 120 days.
The devices deliver ultrasonic energy through an oscillating tip, which leads to tissue fragmentation. This can lead to tissue dissemination that cannot be eliminated by suction/aspiration. In advanced cancers, the risk of dissemination may be outweighed by the benefits of the devices, including the debulking effect with no thermal collateral damage, as well as avoidance of the need for organ removal or resection.
The devices are currently labeled in a way that suggests they could be used in removing uterine fibroids, though the agency said that it is not aware that they are used for this purpose.
The agency recommended against their use in uterine fibroids, in part because there are alternative treatment options available. But the American College of Obstetricians and Gynecologists has challenged that assertion. When the FDA first issued a draft notice of the labeling guidance in November 2016, ACOG commented that abdominal hysterectomy is the alternative treatment option and is associated with significant morbidity and mortality beyond that seen with minimally invasive techniques. ACOG urged the FDA to prioritize informed consent and the weighing of risks and benefits.
Ultrasonic surgical aspirator devices are used for a wide range of surgical applications, but the recommendations apply specifically to laparoscopic surgery, open surgery, and gynecologic surgery.
, according to the Food and Drug Administration.
These devices have the potential to disseminate undetected tumor tissue, and there are no proven preoperative screening methods for detecting uterine sarcoma in uterine fibroids that otherwise appear to be benign, FDA officials wrote in a guidance document issued Oct. 30. The FDA is calling for new product labeling for these devices within 120 days.
The devices deliver ultrasonic energy through an oscillating tip, which leads to tissue fragmentation. This can lead to tissue dissemination that cannot be eliminated by suction/aspiration. In advanced cancers, the risk of dissemination may be outweighed by the benefits of the devices, including the debulking effect with no thermal collateral damage, as well as avoidance of the need for organ removal or resection.
The devices are currently labeled in a way that suggests they could be used in removing uterine fibroids, though the agency said that it is not aware that they are used for this purpose.
The agency recommended against their use in uterine fibroids, in part because there are alternative treatment options available. But the American College of Obstetricians and Gynecologists has challenged that assertion. When the FDA first issued a draft notice of the labeling guidance in November 2016, ACOG commented that abdominal hysterectomy is the alternative treatment option and is associated with significant morbidity and mortality beyond that seen with minimally invasive techniques. ACOG urged the FDA to prioritize informed consent and the weighing of risks and benefits.
Ultrasonic surgical aspirator devices are used for a wide range of surgical applications, but the recommendations apply specifically to laparoscopic surgery, open surgery, and gynecologic surgery.
, according to the Food and Drug Administration.
These devices have the potential to disseminate undetected tumor tissue, and there are no proven preoperative screening methods for detecting uterine sarcoma in uterine fibroids that otherwise appear to be benign, FDA officials wrote in a guidance document issued Oct. 30. The FDA is calling for new product labeling for these devices within 120 days.
The devices deliver ultrasonic energy through an oscillating tip, which leads to tissue fragmentation. This can lead to tissue dissemination that cannot be eliminated by suction/aspiration. In advanced cancers, the risk of dissemination may be outweighed by the benefits of the devices, including the debulking effect with no thermal collateral damage, as well as avoidance of the need for organ removal or resection.
The devices are currently labeled in a way that suggests they could be used in removing uterine fibroids, though the agency said that it is not aware that they are used for this purpose.
The agency recommended against their use in uterine fibroids, in part because there are alternative treatment options available. But the American College of Obstetricians and Gynecologists has challenged that assertion. When the FDA first issued a draft notice of the labeling guidance in November 2016, ACOG commented that abdominal hysterectomy is the alternative treatment option and is associated with significant morbidity and mortality beyond that seen with minimally invasive techniques. ACOG urged the FDA to prioritize informed consent and the weighing of risks and benefits.
Ultrasonic surgical aspirator devices are used for a wide range of surgical applications, but the recommendations apply specifically to laparoscopic surgery, open surgery, and gynecologic surgery.
Some measures to control HAI sound better than they perform
SAN DIEGO – Some almost universally accepted measures against hospital-acquired infections are more costly, annoying, and time consuming than they’re worth, presenters agreed during a panel discussion at the annual clinical congress of the American College of Surgeons.
Intra-abdominal antibiotic irrigation, chlorhexidine bathing, and even postsurgical antibiotic infusions have not consistently been shown to reduce infections. These measures do, however, ratchet up costs and can contribute to antibiotic resistance.
Some of these and other measures to prevent nosocomial infections may indeed reduce the risk, but the gain is small, said Charles H. Cook, MD.
“Chlorhexidine bathing, for example, is touted by many as a panacea for all the infections we’re talking about,” said Dr. Cook, a critical care surgeon at Beth Israel Deaconess Medical Center, New York. “A recent meta-analysis in critical care units did find a reduced relative risk of 0.44 for central line bloodstream infections. But you needed to bathe 360 patients to prevent one infection. It’s what I call a long run for a short slide.”
Therese Duane, MD, FACS, agreed. A surgeon at the John Peter Smith Hospital, Ft. Worth, Tex., Dr. Duane reviewed three different guidelines for the prevention of surgical site infections: the ACS and Surgical Infection Society, the World Health Organization, and the Centers for Disease Control and Prevention. In looking for similarities between the documents, she said she found several well-accepted practices that just aren’t supported by good data.
Presurgical antimicrobial infusions got a strong thumbs-up from all the groups, but only under a very specific circumstance: The medication has to be administered well in advance of surgery for it to be effective.
“Your goal is to get the appropriate concentration into the tissues by the time of incision,” Dr. Duane said. “It takes time to get there – if you give it after the incision, you have bleeding and cellular death, and the antimicrobials cannot get to that incision and do their job. If I’m starting a case and they haven’t been given, I don’t ever start them after the incision, because then you have all of the risks and none of the benefits. In my opinion, we need to move to no further antimicrobials once the incision or case is over because it serves no purpose and is inconsistent with good antibiotic stewardship.”
Adhesive drapes got a resounding “eh” from the guidelines, Dr. Duane said. “You really do not need them. They’re expensive and they’re not improving outcomes, so don’t waste your time or money. We need to think about minimizing what isn’t helpful and maximizing the things that are worthwhile. That’s the way to practice good socially responsible surgery without breaking the bank,” she said.
Antimicrobial sutures got weak recommendations, Dr. Duane said. The evidence supporting their use was not very strong, although she said she feels triclosan-coated sutures are helpful in all kinds of surgery. Preoperative showering with an antiseptic received strong support, with alcohol-containing preps superior to chlorhexidine, which is better than povidone-iodine–containing solutions.
Deep-space irrigation with aqueous iodophor also received a weak recommendation, but Dr. Duane said the evidence does not support the use of antibiotic-containing irrigation in either the abdomen or the incision. “And the guidelines came out strongly against using antimicrobial agents on the incision,” she said. None of the guidelines issued a recommendation for or against antimicrobial dressings.
Protocolized infection-control bundles are a very great help in reducing the incidence of surgical site infections, Dr. Duane added. “They increase attention to detail and decrease the rates of infection.”
Dr. Cook agreed. “Central line bundles are one of the things that work” for line-associated bloodstream infections, he said. Since their large-scale adoption, mortality from these infections has dropped significantly; it was hovering around 28,000 per year in the mid-2000s, he said. “That’s about how many men die from prostate cancer every year.”
Central line infections are very costly too, he added – around $46,000 per event. “That comes to around $2 billion in direct and indirect costs every year.”
A 2006 study demonstrated the efficacy of central line bundles in the fight against these potentially devastating infections.
The bundled intervention comprised hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters. The median rate of catheter-related bloodstream infections per 1,000 catheter-days decreased from 2.7 at baseline to 0 at 3 months after implementation of the study intervention.
Antibiotic-coated or impregnated catheters do not work as well. A 2016 Cochrane review of 57 studies determined that the devices didn’t improve sepsis, all-cause mortality, or catheter-related local infections.
The jury may still be out on coated dressings or securing devices, however. Another Cochrane review, of 22 studies, found a 40% decrease in central line–associated bloodstream infections with these items. “There was moderate evidence that tip colonization was reduced, but the authors said more research is needed.”
The evidence looks stronger for alcohol-impregnated port protectors, Dr. Cook said. Two studies in particular support their use. In an oncology unit, the rate of these infections dropped from 2.3 to 0.3 per 1,000 catheter days after the port protectors were instituted.
In the second study, infection rates declined from 1.43 to 0.69 per 1,000 line-days after the protectors came on board.
“The advantage was seen mostly in ICUs, so the recommendations are to use them there,” Dr. Cook said.
Neither Dr. Cook nor Dr. Duane had any relevant financial disclosures.
[email protected]
On Twitter @Alz Gal
SAN DIEGO – Some almost universally accepted measures against hospital-acquired infections are more costly, annoying, and time consuming than they’re worth, presenters agreed during a panel discussion at the annual clinical congress of the American College of Surgeons.
Intra-abdominal antibiotic irrigation, chlorhexidine bathing, and even postsurgical antibiotic infusions have not consistently been shown to reduce infections. These measures do, however, ratchet up costs and can contribute to antibiotic resistance.
Some of these and other measures to prevent nosocomial infections may indeed reduce the risk, but the gain is small, said Charles H. Cook, MD.
“Chlorhexidine bathing, for example, is touted by many as a panacea for all the infections we’re talking about,” said Dr. Cook, a critical care surgeon at Beth Israel Deaconess Medical Center, New York. “A recent meta-analysis in critical care units did find a reduced relative risk of 0.44 for central line bloodstream infections. But you needed to bathe 360 patients to prevent one infection. It’s what I call a long run for a short slide.”
Therese Duane, MD, FACS, agreed. A surgeon at the John Peter Smith Hospital, Ft. Worth, Tex., Dr. Duane reviewed three different guidelines for the prevention of surgical site infections: the ACS and Surgical Infection Society, the World Health Organization, and the Centers for Disease Control and Prevention. In looking for similarities between the documents, she said she found several well-accepted practices that just aren’t supported by good data.
Presurgical antimicrobial infusions got a strong thumbs-up from all the groups, but only under a very specific circumstance: The medication has to be administered well in advance of surgery for it to be effective.
“Your goal is to get the appropriate concentration into the tissues by the time of incision,” Dr. Duane said. “It takes time to get there – if you give it after the incision, you have bleeding and cellular death, and the antimicrobials cannot get to that incision and do their job. If I’m starting a case and they haven’t been given, I don’t ever start them after the incision, because then you have all of the risks and none of the benefits. In my opinion, we need to move to no further antimicrobials once the incision or case is over because it serves no purpose and is inconsistent with good antibiotic stewardship.”
Adhesive drapes got a resounding “eh” from the guidelines, Dr. Duane said. “You really do not need them. They’re expensive and they’re not improving outcomes, so don’t waste your time or money. We need to think about minimizing what isn’t helpful and maximizing the things that are worthwhile. That’s the way to practice good socially responsible surgery without breaking the bank,” she said.
Antimicrobial sutures got weak recommendations, Dr. Duane said. The evidence supporting their use was not very strong, although she said she feels triclosan-coated sutures are helpful in all kinds of surgery. Preoperative showering with an antiseptic received strong support, with alcohol-containing preps superior to chlorhexidine, which is better than povidone-iodine–containing solutions.
Deep-space irrigation with aqueous iodophor also received a weak recommendation, but Dr. Duane said the evidence does not support the use of antibiotic-containing irrigation in either the abdomen or the incision. “And the guidelines came out strongly against using antimicrobial agents on the incision,” she said. None of the guidelines issued a recommendation for or against antimicrobial dressings.
Protocolized infection-control bundles are a very great help in reducing the incidence of surgical site infections, Dr. Duane added. “They increase attention to detail and decrease the rates of infection.”
Dr. Cook agreed. “Central line bundles are one of the things that work” for line-associated bloodstream infections, he said. Since their large-scale adoption, mortality from these infections has dropped significantly; it was hovering around 28,000 per year in the mid-2000s, he said. “That’s about how many men die from prostate cancer every year.”
Central line infections are very costly too, he added – around $46,000 per event. “That comes to around $2 billion in direct and indirect costs every year.”
A 2006 study demonstrated the efficacy of central line bundles in the fight against these potentially devastating infections.
The bundled intervention comprised hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters. The median rate of catheter-related bloodstream infections per 1,000 catheter-days decreased from 2.7 at baseline to 0 at 3 months after implementation of the study intervention.
Antibiotic-coated or impregnated catheters do not work as well. A 2016 Cochrane review of 57 studies determined that the devices didn’t improve sepsis, all-cause mortality, or catheter-related local infections.
The jury may still be out on coated dressings or securing devices, however. Another Cochrane review, of 22 studies, found a 40% decrease in central line–associated bloodstream infections with these items. “There was moderate evidence that tip colonization was reduced, but the authors said more research is needed.”
The evidence looks stronger for alcohol-impregnated port protectors, Dr. Cook said. Two studies in particular support their use. In an oncology unit, the rate of these infections dropped from 2.3 to 0.3 per 1,000 catheter days after the port protectors were instituted.
In the second study, infection rates declined from 1.43 to 0.69 per 1,000 line-days after the protectors came on board.
“The advantage was seen mostly in ICUs, so the recommendations are to use them there,” Dr. Cook said.
Neither Dr. Cook nor Dr. Duane had any relevant financial disclosures.
[email protected]
On Twitter @Alz Gal
SAN DIEGO – Some almost universally accepted measures against hospital-acquired infections are more costly, annoying, and time consuming than they’re worth, presenters agreed during a panel discussion at the annual clinical congress of the American College of Surgeons.
Intra-abdominal antibiotic irrigation, chlorhexidine bathing, and even postsurgical antibiotic infusions have not consistently been shown to reduce infections. These measures do, however, ratchet up costs and can contribute to antibiotic resistance.
Some of these and other measures to prevent nosocomial infections may indeed reduce the risk, but the gain is small, said Charles H. Cook, MD.
“Chlorhexidine bathing, for example, is touted by many as a panacea for all the infections we’re talking about,” said Dr. Cook, a critical care surgeon at Beth Israel Deaconess Medical Center, New York. “A recent meta-analysis in critical care units did find a reduced relative risk of 0.44 for central line bloodstream infections. But you needed to bathe 360 patients to prevent one infection. It’s what I call a long run for a short slide.”
Therese Duane, MD, FACS, agreed. A surgeon at the John Peter Smith Hospital, Ft. Worth, Tex., Dr. Duane reviewed three different guidelines for the prevention of surgical site infections: the ACS and Surgical Infection Society, the World Health Organization, and the Centers for Disease Control and Prevention. In looking for similarities between the documents, she said she found several well-accepted practices that just aren’t supported by good data.
Presurgical antimicrobial infusions got a strong thumbs-up from all the groups, but only under a very specific circumstance: The medication has to be administered well in advance of surgery for it to be effective.
“Your goal is to get the appropriate concentration into the tissues by the time of incision,” Dr. Duane said. “It takes time to get there – if you give it after the incision, you have bleeding and cellular death, and the antimicrobials cannot get to that incision and do their job. If I’m starting a case and they haven’t been given, I don’t ever start them after the incision, because then you have all of the risks and none of the benefits. In my opinion, we need to move to no further antimicrobials once the incision or case is over because it serves no purpose and is inconsistent with good antibiotic stewardship.”
Adhesive drapes got a resounding “eh” from the guidelines, Dr. Duane said. “You really do not need them. They’re expensive and they’re not improving outcomes, so don’t waste your time or money. We need to think about minimizing what isn’t helpful and maximizing the things that are worthwhile. That’s the way to practice good socially responsible surgery without breaking the bank,” she said.
Antimicrobial sutures got weak recommendations, Dr. Duane said. The evidence supporting their use was not very strong, although she said she feels triclosan-coated sutures are helpful in all kinds of surgery. Preoperative showering with an antiseptic received strong support, with alcohol-containing preps superior to chlorhexidine, which is better than povidone-iodine–containing solutions.
Deep-space irrigation with aqueous iodophor also received a weak recommendation, but Dr. Duane said the evidence does not support the use of antibiotic-containing irrigation in either the abdomen or the incision. “And the guidelines came out strongly against using antimicrobial agents on the incision,” she said. None of the guidelines issued a recommendation for or against antimicrobial dressings.
Protocolized infection-control bundles are a very great help in reducing the incidence of surgical site infections, Dr. Duane added. “They increase attention to detail and decrease the rates of infection.”
Dr. Cook agreed. “Central line bundles are one of the things that work” for line-associated bloodstream infections, he said. Since their large-scale adoption, mortality from these infections has dropped significantly; it was hovering around 28,000 per year in the mid-2000s, he said. “That’s about how many men die from prostate cancer every year.”
Central line infections are very costly too, he added – around $46,000 per event. “That comes to around $2 billion in direct and indirect costs every year.”
A 2006 study demonstrated the efficacy of central line bundles in the fight against these potentially devastating infections.
The bundled intervention comprised hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters. The median rate of catheter-related bloodstream infections per 1,000 catheter-days decreased from 2.7 at baseline to 0 at 3 months after implementation of the study intervention.
Antibiotic-coated or impregnated catheters do not work as well. A 2016 Cochrane review of 57 studies determined that the devices didn’t improve sepsis, all-cause mortality, or catheter-related local infections.
The jury may still be out on coated dressings or securing devices, however. Another Cochrane review, of 22 studies, found a 40% decrease in central line–associated bloodstream infections with these items. “There was moderate evidence that tip colonization was reduced, but the authors said more research is needed.”
The evidence looks stronger for alcohol-impregnated port protectors, Dr. Cook said. Two studies in particular support their use. In an oncology unit, the rate of these infections dropped from 2.3 to 0.3 per 1,000 catheter days after the port protectors were instituted.
In the second study, infection rates declined from 1.43 to 0.69 per 1,000 line-days after the protectors came on board.
“The advantage was seen mostly in ICUs, so the recommendations are to use them there,” Dr. Cook said.
Neither Dr. Cook nor Dr. Duane had any relevant financial disclosures.
[email protected]
On Twitter @Alz Gal
FROM THE ACS CLINICAL CONGRESS
Government uncertainty drives jump in ACA silver plan insurance premiums
Silver plans on the Affordable Care Act insurance exchanges in 2018 will see an average premium increase of 34% nationwide, according to new research from Avalere Health.
“Plans are raising premiums in 2018 to account for market uncertainty and the federal government’s failure to pay for cost-sharing reductions,” Caroline Pearson, senior vice president at Avalere, said in a statement. “These premium increases may allow insurers to remain in the market and enrollees in all regions to have access to coverage.”
The expected premium changes are highly variable by state. Iowa has the highest change in its silver plans, with an average premium increase of 69% for its silver plans, while at the other end of the spectrum, Alaska is actually seeing a 22% decrease.
“These rates may change prior to open enrollment depending on how states respond to the elimination of CSR [cost-sharing reduction] funding for the 2018 plan year,” Avalere notes in its new analysis, adding that states may allow plans to refile for rate hikes now that CSR funding is likely dead. “In states where this occurs, it is expected that the newly updated rates will be substantially higher for the 2018 plan year.”
There was a glimmer of hope that the CSR payments would resume after a compromise was reached in the Senate Health, Education, Labor & Pensions Committee by Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) that would offer 2 years of funding along with flexibility in the waiver program to allow states to tweak Affordable Care Act requirements. However, Speaker Paul Ryan (R-Wisc.) said the House would not be taking on any more health care action for the remainder of the year.
A spokeswoman from America’s Health Insurance Plans said in an interview that, although the CSR payments are no more, premium tax credits still exist to help lower-income individuals obtain insurance coverage.
Mike Nelson, MD, FCCP, comments: One need not “google” too long to find that the United States performs quite poorly in overall health care when compared with other nations, despite spending more than any of the comparators…we’re 37th this year. This information from Avalere Health portends a further drop in our ranking next year. The privilege of good health is a responsibility of the individual, but the right to affordable health care is a responsibility of the government. It is time for our legislators to stop playing partisan politics and start communicating to propose a workable and affordable solution.
Mike Nelson, MD, FCCP, comments: One need not “google” too long to find that the United States performs quite poorly in overall health care when compared with other nations, despite spending more than any of the comparators…we’re 37th this year. This information from Avalere Health portends a further drop in our ranking next year. The privilege of good health is a responsibility of the individual, but the right to affordable health care is a responsibility of the government. It is time for our legislators to stop playing partisan politics and start communicating to propose a workable and affordable solution.
Mike Nelson, MD, FCCP, comments: One need not “google” too long to find that the United States performs quite poorly in overall health care when compared with other nations, despite spending more than any of the comparators…we’re 37th this year. This information from Avalere Health portends a further drop in our ranking next year. The privilege of good health is a responsibility of the individual, but the right to affordable health care is a responsibility of the government. It is time for our legislators to stop playing partisan politics and start communicating to propose a workable and affordable solution.
Silver plans on the Affordable Care Act insurance exchanges in 2018 will see an average premium increase of 34% nationwide, according to new research from Avalere Health.
“Plans are raising premiums in 2018 to account for market uncertainty and the federal government’s failure to pay for cost-sharing reductions,” Caroline Pearson, senior vice president at Avalere, said in a statement. “These premium increases may allow insurers to remain in the market and enrollees in all regions to have access to coverage.”
The expected premium changes are highly variable by state. Iowa has the highest change in its silver plans, with an average premium increase of 69% for its silver plans, while at the other end of the spectrum, Alaska is actually seeing a 22% decrease.
“These rates may change prior to open enrollment depending on how states respond to the elimination of CSR [cost-sharing reduction] funding for the 2018 plan year,” Avalere notes in its new analysis, adding that states may allow plans to refile for rate hikes now that CSR funding is likely dead. “In states where this occurs, it is expected that the newly updated rates will be substantially higher for the 2018 plan year.”
There was a glimmer of hope that the CSR payments would resume after a compromise was reached in the Senate Health, Education, Labor & Pensions Committee by Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) that would offer 2 years of funding along with flexibility in the waiver program to allow states to tweak Affordable Care Act requirements. However, Speaker Paul Ryan (R-Wisc.) said the House would not be taking on any more health care action for the remainder of the year.
A spokeswoman from America’s Health Insurance Plans said in an interview that, although the CSR payments are no more, premium tax credits still exist to help lower-income individuals obtain insurance coverage.
Silver plans on the Affordable Care Act insurance exchanges in 2018 will see an average premium increase of 34% nationwide, according to new research from Avalere Health.
“Plans are raising premiums in 2018 to account for market uncertainty and the federal government’s failure to pay for cost-sharing reductions,” Caroline Pearson, senior vice president at Avalere, said in a statement. “These premium increases may allow insurers to remain in the market and enrollees in all regions to have access to coverage.”
The expected premium changes are highly variable by state. Iowa has the highest change in its silver plans, with an average premium increase of 69% for its silver plans, while at the other end of the spectrum, Alaska is actually seeing a 22% decrease.
“These rates may change prior to open enrollment depending on how states respond to the elimination of CSR [cost-sharing reduction] funding for the 2018 plan year,” Avalere notes in its new analysis, adding that states may allow plans to refile for rate hikes now that CSR funding is likely dead. “In states where this occurs, it is expected that the newly updated rates will be substantially higher for the 2018 plan year.”
There was a glimmer of hope that the CSR payments would resume after a compromise was reached in the Senate Health, Education, Labor & Pensions Committee by Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) that would offer 2 years of funding along with flexibility in the waiver program to allow states to tweak Affordable Care Act requirements. However, Speaker Paul Ryan (R-Wisc.) said the House would not be taking on any more health care action for the remainder of the year.
A spokeswoman from America’s Health Insurance Plans said in an interview that, although the CSR payments are no more, premium tax credits still exist to help lower-income individuals obtain insurance coverage.