Official Newspaper of the American College of Surgeons

Top Sections
From the Editor
Palliative Care
The Right Choice?
The Rural Surgeon
sn
Main menu
SN Main Menu
Explore menu
SN Explore Menu
Proclivity ID
18821001
Unpublish
Specialty Focus
Pain
Colon and Rectal
General Surgery
Plastic Surgery
Cardiothoracic
Altmetric
Article Authors "autobrand" affiliation
MDedge News
DSM Affiliated
Display in offset block
Disqus Exclude
Best Practices
CE/CME
Education Center
Medical Education Library
Enable Disqus
Display Author and Disclosure Link
Publication Type
News
Slot System
Top 25
Disable Sticky Ads
Disable Ad Block Mitigation
Featured Buckets Admin
Show Ads on this Publication's Homepage
Consolidated Pub
Show Article Page Numbers on TOC
Display logo in consolidated pubs except when content has these publications
Use larger logo size
Off
publication_blueconic_enabled
Off
Show More Destinations Menu
Disable Adhesion on Publication
Off
Restore Menu Label on Mobile Navigation
Disable Facebook Pixel from Publication
Exclude this publication from publication selection on articles and quiz

HIT risk rises with obesity

Article Type
Changed
Display Headline
HIT risk rises with obesity

LAS VEGAS – High body mass index is strongly associated with increased rates of heparin-induced thrombocytopenia, based on findings from a review of prospectively collected data from surgical and cardiac intensive care unit patients presumed to have the condition.

Of 304 patients included in the review, 36 (12%) were positive for heparin-induced thrombocytopenia (HIT). The rates increased in tandem with BMI. For example, the rate was 0% among 9 underweight individuals (BMI less than 18.5 kg/m2), 8% among 119 normal-weight individuals (BMI of 18.5-24.9 kg/m2), 11% among 98 overweight individuals (BMI of 25-29.9 kg/m2), 18% among 67 obese individuals (BMI of 30-39.9 kg/m2), and 36% among 11 morbidly obese individuals (BMI of 40 kg/m2 or greater), Dr. Matthew B. Bloom reported at the annual meeting of the American Association for the Surgery of Trauma.

Wikimedia Commons
Structure of the PF4 protein. Based on PyMOL rendering of PDB

The odds of HIT were 170% greater among obese patients, compared with normal-weight patients (odds ratio, 2.67), and 600% greater among morbidly obese patients, compared with normal-weight patient (odds ratio, 6.98), said Dr. Bloom of Cedars-Sinai Medical Center, Los Angeles.

Logistic regression showed that each 1 unit increase in BMI was associated with a 7.7% increase in the odds of developing HIT, he noted.

Additionally, an anti-heparin/PF4 (platelet factor 4) antibody OD (optical density) value of 2.0 or greater, but not of 0.4 or greater or 0.8 or greater, was also significantly increased with BMI, and in-hospital mortality increased significantly with BMI above normal, he said.

Warkentin 4T scores used to differentiate HIT from other types of thrombocytopenia were not found to correlate with changes in BMI in this study, nor were deep vein thrombosis, pulmonary embolism, or stroke.

The increase in PF4 with increasing BMI may be a marker for overall increasing levels of circulating antibodies in the obese ICU population, but more biochemical studies are needed to tease this out, he said.

Patients included in the review were all those admitted to the surgical and cardiac ICUs at Cedars-Sinai over a more than 7 year period. They had a mean age of 62.1 years, 59% were men, and their mean BMI was 27 kg/m2.

The findings are among the first to show a strong association between BMI and HIT in ICU patients, Dr. Bloom said, noting that several other studies have shown that obesity is linked with increased incidence and increased severity of immune-mediated diseases, including rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease.

“And HIT is an immune-mediated disease,” he added.

“BMI may be an important new clinical variable for estimating the pre-test probability of HIT, and perhaps, in the future, patient ‘thickness’ could be considered a new ‘T’ in the 4T score, he concluded.

Dr. Bloom reported having no disclosures.

sworcester@frontlinemedcom.com

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
body mass index, BMI, heparin-induced thrombocytopenia, HIT
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

LAS VEGAS – High body mass index is strongly associated with increased rates of heparin-induced thrombocytopenia, based on findings from a review of prospectively collected data from surgical and cardiac intensive care unit patients presumed to have the condition.

Of 304 patients included in the review, 36 (12%) were positive for heparin-induced thrombocytopenia (HIT). The rates increased in tandem with BMI. For example, the rate was 0% among 9 underweight individuals (BMI less than 18.5 kg/m2), 8% among 119 normal-weight individuals (BMI of 18.5-24.9 kg/m2), 11% among 98 overweight individuals (BMI of 25-29.9 kg/m2), 18% among 67 obese individuals (BMI of 30-39.9 kg/m2), and 36% among 11 morbidly obese individuals (BMI of 40 kg/m2 or greater), Dr. Matthew B. Bloom reported at the annual meeting of the American Association for the Surgery of Trauma.

Wikimedia Commons
Structure of the PF4 protein. Based on PyMOL rendering of PDB

The odds of HIT were 170% greater among obese patients, compared with normal-weight patients (odds ratio, 2.67), and 600% greater among morbidly obese patients, compared with normal-weight patient (odds ratio, 6.98), said Dr. Bloom of Cedars-Sinai Medical Center, Los Angeles.

Logistic regression showed that each 1 unit increase in BMI was associated with a 7.7% increase in the odds of developing HIT, he noted.

Additionally, an anti-heparin/PF4 (platelet factor 4) antibody OD (optical density) value of 2.0 or greater, but not of 0.4 or greater or 0.8 or greater, was also significantly increased with BMI, and in-hospital mortality increased significantly with BMI above normal, he said.

Warkentin 4T scores used to differentiate HIT from other types of thrombocytopenia were not found to correlate with changes in BMI in this study, nor were deep vein thrombosis, pulmonary embolism, or stroke.

The increase in PF4 with increasing BMI may be a marker for overall increasing levels of circulating antibodies in the obese ICU population, but more biochemical studies are needed to tease this out, he said.

Patients included in the review were all those admitted to the surgical and cardiac ICUs at Cedars-Sinai over a more than 7 year period. They had a mean age of 62.1 years, 59% were men, and their mean BMI was 27 kg/m2.

The findings are among the first to show a strong association between BMI and HIT in ICU patients, Dr. Bloom said, noting that several other studies have shown that obesity is linked with increased incidence and increased severity of immune-mediated diseases, including rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease.

“And HIT is an immune-mediated disease,” he added.

“BMI may be an important new clinical variable for estimating the pre-test probability of HIT, and perhaps, in the future, patient ‘thickness’ could be considered a new ‘T’ in the 4T score, he concluded.

Dr. Bloom reported having no disclosures.

sworcester@frontlinemedcom.com

LAS VEGAS – High body mass index is strongly associated with increased rates of heparin-induced thrombocytopenia, based on findings from a review of prospectively collected data from surgical and cardiac intensive care unit patients presumed to have the condition.

Of 304 patients included in the review, 36 (12%) were positive for heparin-induced thrombocytopenia (HIT). The rates increased in tandem with BMI. For example, the rate was 0% among 9 underweight individuals (BMI less than 18.5 kg/m2), 8% among 119 normal-weight individuals (BMI of 18.5-24.9 kg/m2), 11% among 98 overweight individuals (BMI of 25-29.9 kg/m2), 18% among 67 obese individuals (BMI of 30-39.9 kg/m2), and 36% among 11 morbidly obese individuals (BMI of 40 kg/m2 or greater), Dr. Matthew B. Bloom reported at the annual meeting of the American Association for the Surgery of Trauma.

Wikimedia Commons
Structure of the PF4 protein. Based on PyMOL rendering of PDB

The odds of HIT were 170% greater among obese patients, compared with normal-weight patients (odds ratio, 2.67), and 600% greater among morbidly obese patients, compared with normal-weight patient (odds ratio, 6.98), said Dr. Bloom of Cedars-Sinai Medical Center, Los Angeles.

Logistic regression showed that each 1 unit increase in BMI was associated with a 7.7% increase in the odds of developing HIT, he noted.

Additionally, an anti-heparin/PF4 (platelet factor 4) antibody OD (optical density) value of 2.0 or greater, but not of 0.4 or greater or 0.8 or greater, was also significantly increased with BMI, and in-hospital mortality increased significantly with BMI above normal, he said.

Warkentin 4T scores used to differentiate HIT from other types of thrombocytopenia were not found to correlate with changes in BMI in this study, nor were deep vein thrombosis, pulmonary embolism, or stroke.

The increase in PF4 with increasing BMI may be a marker for overall increasing levels of circulating antibodies in the obese ICU population, but more biochemical studies are needed to tease this out, he said.

Patients included in the review were all those admitted to the surgical and cardiac ICUs at Cedars-Sinai over a more than 7 year period. They had a mean age of 62.1 years, 59% were men, and their mean BMI was 27 kg/m2.

The findings are among the first to show a strong association between BMI and HIT in ICU patients, Dr. Bloom said, noting that several other studies have shown that obesity is linked with increased incidence and increased severity of immune-mediated diseases, including rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease.

“And HIT is an immune-mediated disease,” he added.

“BMI may be an important new clinical variable for estimating the pre-test probability of HIT, and perhaps, in the future, patient ‘thickness’ could be considered a new ‘T’ in the 4T score, he concluded.

Dr. Bloom reported having no disclosures.

sworcester@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
HIT risk rises with obesity
Display Headline
HIT risk rises with obesity
Legacy Keywords
body mass index, BMI, heparin-induced thrombocytopenia, HIT
Legacy Keywords
body mass index, BMI, heparin-induced thrombocytopenia, HIT
Sections
Article Source

AT THE AAST ANNUAL MEETING

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Higher body mass index is strongly associated with increased rates of heparin-induced thrombocytopenia.

Major finding: The HIT rate was 0%, 8%, 11%, 18,%, and 36% among underweight, normal-weight, overweight, obese, and morbidly obese individuals, respectively.

Data source: A review of prospectively collected data for 304 patients.

Disclosures: Dr. Bloom reported having no disclosures.

2016 Medicare fee schedule: What should you know?

Article Type
Changed
Display Headline
2016 Medicare fee schedule: What should you know?

The comments are in and shaping of the final Medicare Physician Fee Schedule for 2016 rests now in the hands of officials at the Centers for Medicare & Medicaid Services. What are the key provisions doctors need to know about to practice successfully in 2016? Experts gave their opinions in a webinar sponsored by the American Health Lawyers Association (AHLA).

Julie E. Kass

Physician Quality Reporting System (PQRS)

CMS proposes to audit not only physician participants, but also vendors who submit quality measure data on behalf of doctors, under the 2016 proposed fee schedule. The agency recommends that vendors make available contact information for each eligible practitioner on behalf of whom it submits data and retain data submitted to CMS for PQRS for 7 years.

Doctors who fail to report on nine quality measures for PQRS will not automatically face trouble, according to Daniel F. Shay, a health law attorney in Philadelphia. In general, individual physicians in PQRS must report on at least nine measures covering three National Quality Strategy (NQS) domains for at least 50% of their Medicare patient base. But if fewer than nine measures are reported, physicians have the chance to explain themselves.

“In some cases, a practice may not have at least nine measures that apply to it, Mr. Shay said. “The [eligible practitioner] would then be able to report on fewer than nine measures, but would be subject to the measure application validity process, which basically means CMS audits the provider to prove they couldn’t have reported on all of the required measures.”

Also, CMS proposes extending participation in PQRS to doctors who practice in critical access hospitals, according to the 2016 proposed fee schedule. PQRS is a voluntary quality reporting program that applies adjustments to payments based on benchmarks. CMS is suggesting that physicians who practice in certain critical access hospitals now have the option to participate in the program – such doctors were previously excluded.

Incident to service

When overseeing care that is “incident to” service, CMS proposes that billing physicians also act as supervising physicians. The proposal could significantly impact group practices who do not typically use that structure, said Washington health law attorney Julie E. Kass during the AHLA webinar.

Incident to is defined as services furnished incident to a physician’s professional services over the course of a patient’s diagnosis or treatment. Medicare pays for services rendered by employees of a physician only when all “incident to” criteria are met. Those criteria include that services rendered by nonphysicians are under the direct supervision of a physician physically in the same office suite. In the proposed 2016 rule, CMS seeks to clarify that the billing physician must be the same physician who supervises the ancillary personnel. Previously, group practices may have billed under the provider who ordered the treatment, according to Ms. Kass.

“It sounds simple, but then you put it into the context of what happens in a real life practice,” she said. “I think a lot of practices, in operationalizing this rule, have generally used the ordering physician as the physician who billed for the service without paying a lot of attention to who was the actual supervising physician.”

Group practices may want to rethink how they bill for incident to services, and ensure the billing physician is the one who supervises the treatment, she advised.

The Stark Law

Proposed changes to regulations implementing the Stark Law could make it easier for physicians to hire new nonphysician providers (NPP) to provide primary care. Under the fee schedule proposal, hospitals would be allowed to assist in the recruitment of health professionals for physician practices. Currently, hospitals may not because remuneration could be considered a compensation relationship between the hospital and physician practice. The proposed change aims to promote care team collaboration and help curb primary care shortages.

The exception would permit recruitment assistance and retention payment from a hospital, rural health clinic, or federally qualified health center to a physician practice to employ an NPP. However, the NPP would have to be a bona fide employee of the physician practice and provide primary care services. CMS defines an NPP as a physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse-midwife. CMS is also recommending a cap on the total remuneration and duration of assistance provided.

The limits aim to “make sure the physicians have skin in the game in bringing in the NPP,” Ms. Kass said. “It’s not all going to be the burden of hospital to provide recruiting assistance, but rather the physician has to need and want the NPP enough to be willing to bring them in as well without total support and assistance.”

 

 

Value-Based Payment Modifier Program

CMS proposes a new way to determine the extent of payment cuts and bonuses in the Value-Based Payment Modifier program. The program evaluates the performance of solo practitioners and groups on the quality and cost of care they provide to fee-for-service Medicare patients.

In 2016, the agency proposes to adjust payments based on the size of the participating group and to determine that size by reviewing claims data and its Provider Enrollment, Chain, and Ownership System (PECOS)-generated list. CMS would apply whichever number is lower in PECOS or claims data.

Now is a good time for doctors to check their PECOS data to ensure the information is accurate and up to date, Mr. Shay recommended.

As many expected, the Value-Based Payment Modifier is slowly expanding to encompass more physicians. Beginning Jan. 1, 2015, the value modifier was applied to physician payments under the fee schedule for groups of 100 or more. In January 2016, it will be applied to physician payments for doctors in groups of 10 or more. In 2017, the modifier will apply to solo practitioners and physicians in groups of two or more. (All modifiers are based on performance periods 2 years prior.)

PQRS will continue to play a central role in the Value-Based Payment Modifier system, Mr. Shay added. CMS is proposing to use the PQRS reporting period for 2016 as the basis for the 2018 value modifier. The agency will draw from the group reporting option and individual EP reporting mechanisms proposed for 2016.

“We’re seeing just more interconnection between these two systems,” Mr. Shay said.

Physician Compare

Physicians should expect to have more information about their performance reported to the Physician Compare website under the proposed 2016 fee schedule. The site already continues information on physician education, location, group affiliations, and status in quality programs. CMS now wants to include performance rates on 2015 PQRS cardiovascular disease prevention measures for doctors who report them, in support of the Million Hearts program. Additionally, CMS proposes that groups receiving a pay increase under the Value-Based Payment Modifier Program report the data to the website. Doctors also would continue reporting information about patient experiences under the Consumer Assessment of Healthcare Providers & Systems (CAHPS) survey program. The surveys are designed to capture a patient’s experience receiving care from their physician.

Mr. Shay noted that one concern with the Physician Compare website is that doctors have little recourse to challenge information on the site. Physicians have only a 30-day window to review information about themselves and correct errors.

“There is no formal appeals mechanism for the website,” Mr. Shay.

CMS is currently reviewing feedback and comments submitted about the proposed physician fee schedule before issuing the final schedule, usually in November.

agallegos@frontlinemedcom.com

On Twitter @legal_med

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
physician fee schedule, Medicare fee schedule, CMS fee schedule
Sections
Author and Disclosure Information

Author and Disclosure Information

The comments are in and shaping of the final Medicare Physician Fee Schedule for 2016 rests now in the hands of officials at the Centers for Medicare & Medicaid Services. What are the key provisions doctors need to know about to practice successfully in 2016? Experts gave their opinions in a webinar sponsored by the American Health Lawyers Association (AHLA).

Julie E. Kass

Physician Quality Reporting System (PQRS)

CMS proposes to audit not only physician participants, but also vendors who submit quality measure data on behalf of doctors, under the 2016 proposed fee schedule. The agency recommends that vendors make available contact information for each eligible practitioner on behalf of whom it submits data and retain data submitted to CMS for PQRS for 7 years.

Doctors who fail to report on nine quality measures for PQRS will not automatically face trouble, according to Daniel F. Shay, a health law attorney in Philadelphia. In general, individual physicians in PQRS must report on at least nine measures covering three National Quality Strategy (NQS) domains for at least 50% of their Medicare patient base. But if fewer than nine measures are reported, physicians have the chance to explain themselves.

“In some cases, a practice may not have at least nine measures that apply to it, Mr. Shay said. “The [eligible practitioner] would then be able to report on fewer than nine measures, but would be subject to the measure application validity process, which basically means CMS audits the provider to prove they couldn’t have reported on all of the required measures.”

Also, CMS proposes extending participation in PQRS to doctors who practice in critical access hospitals, according to the 2016 proposed fee schedule. PQRS is a voluntary quality reporting program that applies adjustments to payments based on benchmarks. CMS is suggesting that physicians who practice in certain critical access hospitals now have the option to participate in the program – such doctors were previously excluded.

Incident to service

When overseeing care that is “incident to” service, CMS proposes that billing physicians also act as supervising physicians. The proposal could significantly impact group practices who do not typically use that structure, said Washington health law attorney Julie E. Kass during the AHLA webinar.

Incident to is defined as services furnished incident to a physician’s professional services over the course of a patient’s diagnosis or treatment. Medicare pays for services rendered by employees of a physician only when all “incident to” criteria are met. Those criteria include that services rendered by nonphysicians are under the direct supervision of a physician physically in the same office suite. In the proposed 2016 rule, CMS seeks to clarify that the billing physician must be the same physician who supervises the ancillary personnel. Previously, group practices may have billed under the provider who ordered the treatment, according to Ms. Kass.

“It sounds simple, but then you put it into the context of what happens in a real life practice,” she said. “I think a lot of practices, in operationalizing this rule, have generally used the ordering physician as the physician who billed for the service without paying a lot of attention to who was the actual supervising physician.”

Group practices may want to rethink how they bill for incident to services, and ensure the billing physician is the one who supervises the treatment, she advised.

The Stark Law

Proposed changes to regulations implementing the Stark Law could make it easier for physicians to hire new nonphysician providers (NPP) to provide primary care. Under the fee schedule proposal, hospitals would be allowed to assist in the recruitment of health professionals for physician practices. Currently, hospitals may not because remuneration could be considered a compensation relationship between the hospital and physician practice. The proposed change aims to promote care team collaboration and help curb primary care shortages.

The exception would permit recruitment assistance and retention payment from a hospital, rural health clinic, or federally qualified health center to a physician practice to employ an NPP. However, the NPP would have to be a bona fide employee of the physician practice and provide primary care services. CMS defines an NPP as a physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse-midwife. CMS is also recommending a cap on the total remuneration and duration of assistance provided.

The limits aim to “make sure the physicians have skin in the game in bringing in the NPP,” Ms. Kass said. “It’s not all going to be the burden of hospital to provide recruiting assistance, but rather the physician has to need and want the NPP enough to be willing to bring them in as well without total support and assistance.”

 

 

Value-Based Payment Modifier Program

CMS proposes a new way to determine the extent of payment cuts and bonuses in the Value-Based Payment Modifier program. The program evaluates the performance of solo practitioners and groups on the quality and cost of care they provide to fee-for-service Medicare patients.

In 2016, the agency proposes to adjust payments based on the size of the participating group and to determine that size by reviewing claims data and its Provider Enrollment, Chain, and Ownership System (PECOS)-generated list. CMS would apply whichever number is lower in PECOS or claims data.

Now is a good time for doctors to check their PECOS data to ensure the information is accurate and up to date, Mr. Shay recommended.

As many expected, the Value-Based Payment Modifier is slowly expanding to encompass more physicians. Beginning Jan. 1, 2015, the value modifier was applied to physician payments under the fee schedule for groups of 100 or more. In January 2016, it will be applied to physician payments for doctors in groups of 10 or more. In 2017, the modifier will apply to solo practitioners and physicians in groups of two or more. (All modifiers are based on performance periods 2 years prior.)

PQRS will continue to play a central role in the Value-Based Payment Modifier system, Mr. Shay added. CMS is proposing to use the PQRS reporting period for 2016 as the basis for the 2018 value modifier. The agency will draw from the group reporting option and individual EP reporting mechanisms proposed for 2016.

“We’re seeing just more interconnection between these two systems,” Mr. Shay said.

Physician Compare

Physicians should expect to have more information about their performance reported to the Physician Compare website under the proposed 2016 fee schedule. The site already continues information on physician education, location, group affiliations, and status in quality programs. CMS now wants to include performance rates on 2015 PQRS cardiovascular disease prevention measures for doctors who report them, in support of the Million Hearts program. Additionally, CMS proposes that groups receiving a pay increase under the Value-Based Payment Modifier Program report the data to the website. Doctors also would continue reporting information about patient experiences under the Consumer Assessment of Healthcare Providers & Systems (CAHPS) survey program. The surveys are designed to capture a patient’s experience receiving care from their physician.

Mr. Shay noted that one concern with the Physician Compare website is that doctors have little recourse to challenge information on the site. Physicians have only a 30-day window to review information about themselves and correct errors.

“There is no formal appeals mechanism for the website,” Mr. Shay.

CMS is currently reviewing feedback and comments submitted about the proposed physician fee schedule before issuing the final schedule, usually in November.

agallegos@frontlinemedcom.com

On Twitter @legal_med

The comments are in and shaping of the final Medicare Physician Fee Schedule for 2016 rests now in the hands of officials at the Centers for Medicare & Medicaid Services. What are the key provisions doctors need to know about to practice successfully in 2016? Experts gave their opinions in a webinar sponsored by the American Health Lawyers Association (AHLA).

Julie E. Kass

Physician Quality Reporting System (PQRS)

CMS proposes to audit not only physician participants, but also vendors who submit quality measure data on behalf of doctors, under the 2016 proposed fee schedule. The agency recommends that vendors make available contact information for each eligible practitioner on behalf of whom it submits data and retain data submitted to CMS for PQRS for 7 years.

Doctors who fail to report on nine quality measures for PQRS will not automatically face trouble, according to Daniel F. Shay, a health law attorney in Philadelphia. In general, individual physicians in PQRS must report on at least nine measures covering three National Quality Strategy (NQS) domains for at least 50% of their Medicare patient base. But if fewer than nine measures are reported, physicians have the chance to explain themselves.

“In some cases, a practice may not have at least nine measures that apply to it, Mr. Shay said. “The [eligible practitioner] would then be able to report on fewer than nine measures, but would be subject to the measure application validity process, which basically means CMS audits the provider to prove they couldn’t have reported on all of the required measures.”

Also, CMS proposes extending participation in PQRS to doctors who practice in critical access hospitals, according to the 2016 proposed fee schedule. PQRS is a voluntary quality reporting program that applies adjustments to payments based on benchmarks. CMS is suggesting that physicians who practice in certain critical access hospitals now have the option to participate in the program – such doctors were previously excluded.

Incident to service

When overseeing care that is “incident to” service, CMS proposes that billing physicians also act as supervising physicians. The proposal could significantly impact group practices who do not typically use that structure, said Washington health law attorney Julie E. Kass during the AHLA webinar.

Incident to is defined as services furnished incident to a physician’s professional services over the course of a patient’s diagnosis or treatment. Medicare pays for services rendered by employees of a physician only when all “incident to” criteria are met. Those criteria include that services rendered by nonphysicians are under the direct supervision of a physician physically in the same office suite. In the proposed 2016 rule, CMS seeks to clarify that the billing physician must be the same physician who supervises the ancillary personnel. Previously, group practices may have billed under the provider who ordered the treatment, according to Ms. Kass.

“It sounds simple, but then you put it into the context of what happens in a real life practice,” she said. “I think a lot of practices, in operationalizing this rule, have generally used the ordering physician as the physician who billed for the service without paying a lot of attention to who was the actual supervising physician.”

Group practices may want to rethink how they bill for incident to services, and ensure the billing physician is the one who supervises the treatment, she advised.

The Stark Law

Proposed changes to regulations implementing the Stark Law could make it easier for physicians to hire new nonphysician providers (NPP) to provide primary care. Under the fee schedule proposal, hospitals would be allowed to assist in the recruitment of health professionals for physician practices. Currently, hospitals may not because remuneration could be considered a compensation relationship between the hospital and physician practice. The proposed change aims to promote care team collaboration and help curb primary care shortages.

The exception would permit recruitment assistance and retention payment from a hospital, rural health clinic, or federally qualified health center to a physician practice to employ an NPP. However, the NPP would have to be a bona fide employee of the physician practice and provide primary care services. CMS defines an NPP as a physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse-midwife. CMS is also recommending a cap on the total remuneration and duration of assistance provided.

The limits aim to “make sure the physicians have skin in the game in bringing in the NPP,” Ms. Kass said. “It’s not all going to be the burden of hospital to provide recruiting assistance, but rather the physician has to need and want the NPP enough to be willing to bring them in as well without total support and assistance.”

 

 

Value-Based Payment Modifier Program

CMS proposes a new way to determine the extent of payment cuts and bonuses in the Value-Based Payment Modifier program. The program evaluates the performance of solo practitioners and groups on the quality and cost of care they provide to fee-for-service Medicare patients.

In 2016, the agency proposes to adjust payments based on the size of the participating group and to determine that size by reviewing claims data and its Provider Enrollment, Chain, and Ownership System (PECOS)-generated list. CMS would apply whichever number is lower in PECOS or claims data.

Now is a good time for doctors to check their PECOS data to ensure the information is accurate and up to date, Mr. Shay recommended.

As many expected, the Value-Based Payment Modifier is slowly expanding to encompass more physicians. Beginning Jan. 1, 2015, the value modifier was applied to physician payments under the fee schedule for groups of 100 or more. In January 2016, it will be applied to physician payments for doctors in groups of 10 or more. In 2017, the modifier will apply to solo practitioners and physicians in groups of two or more. (All modifiers are based on performance periods 2 years prior.)

PQRS will continue to play a central role in the Value-Based Payment Modifier system, Mr. Shay added. CMS is proposing to use the PQRS reporting period for 2016 as the basis for the 2018 value modifier. The agency will draw from the group reporting option and individual EP reporting mechanisms proposed for 2016.

“We’re seeing just more interconnection between these two systems,” Mr. Shay said.

Physician Compare

Physicians should expect to have more information about their performance reported to the Physician Compare website under the proposed 2016 fee schedule. The site already continues information on physician education, location, group affiliations, and status in quality programs. CMS now wants to include performance rates on 2015 PQRS cardiovascular disease prevention measures for doctors who report them, in support of the Million Hearts program. Additionally, CMS proposes that groups receiving a pay increase under the Value-Based Payment Modifier Program report the data to the website. Doctors also would continue reporting information about patient experiences under the Consumer Assessment of Healthcare Providers & Systems (CAHPS) survey program. The surveys are designed to capture a patient’s experience receiving care from their physician.

Mr. Shay noted that one concern with the Physician Compare website is that doctors have little recourse to challenge information on the site. Physicians have only a 30-day window to review information about themselves and correct errors.

“There is no formal appeals mechanism for the website,” Mr. Shay.

CMS is currently reviewing feedback and comments submitted about the proposed physician fee schedule before issuing the final schedule, usually in November.

agallegos@frontlinemedcom.com

On Twitter @legal_med

References

References

Publications
Publications
Topics
Article Type
Display Headline
2016 Medicare fee schedule: What should you know?
Display Headline
2016 Medicare fee schedule: What should you know?
Legacy Keywords
physician fee schedule, Medicare fee schedule, CMS fee schedule
Legacy Keywords
physician fee schedule, Medicare fee schedule, CMS fee schedule
Sections
Article Source

PURLs Copyright

Inside the Article

VIDEO: High-value care: The OCCAM’s initiative

Article Type
Changed
Display Headline
VIDEO: High-value care: The OCCAM’s initiative

What is high-value care and how can it be achieved? Overuse of clinical tests and diagnostic procedures, largely driven by concerns about missing unusual but potentially significant diagnoses, drives health care costs and can result in worrisome incidental findings.

Dr. Hyung “Harry” Cho, a hospitalist and assistant professor of medicine at the Mt. Sinai School of Medicine in New York, has launched the Overuse Clinical Case Morbidity and Mortality (OCCAM’s) Conference to attack the problem of clinical overuse from a new perspective. Dr. Cho and his colleagues have turned the traditional morbidity and mortality conference on its head by addressing overuse as a medical error and using the conference as a forum to discuss which practical steps should be taken to improve quality of care while avoiding overuse of tests.

In this video interview, Dr. Cho – along with other key members of the OCCAM’s team – discuss the initiative’s inception, the importance of workgroups in implementing quality improvement initiatives from the ground up, and how to advance the conversation to define high-value care.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

dchitnis@frontlinemedcom.com

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
high, value, care, OCCAM, Mt. Sinai, Cho, quality, improvement
Author and Disclosure Information

Author and Disclosure Information

What is high-value care and how can it be achieved? Overuse of clinical tests and diagnostic procedures, largely driven by concerns about missing unusual but potentially significant diagnoses, drives health care costs and can result in worrisome incidental findings.

Dr. Hyung “Harry” Cho, a hospitalist and assistant professor of medicine at the Mt. Sinai School of Medicine in New York, has launched the Overuse Clinical Case Morbidity and Mortality (OCCAM’s) Conference to attack the problem of clinical overuse from a new perspective. Dr. Cho and his colleagues have turned the traditional morbidity and mortality conference on its head by addressing overuse as a medical error and using the conference as a forum to discuss which practical steps should be taken to improve quality of care while avoiding overuse of tests.

In this video interview, Dr. Cho – along with other key members of the OCCAM’s team – discuss the initiative’s inception, the importance of workgroups in implementing quality improvement initiatives from the ground up, and how to advance the conversation to define high-value care.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

dchitnis@frontlinemedcom.com

What is high-value care and how can it be achieved? Overuse of clinical tests and diagnostic procedures, largely driven by concerns about missing unusual but potentially significant diagnoses, drives health care costs and can result in worrisome incidental findings.

Dr. Hyung “Harry” Cho, a hospitalist and assistant professor of medicine at the Mt. Sinai School of Medicine in New York, has launched the Overuse Clinical Case Morbidity and Mortality (OCCAM’s) Conference to attack the problem of clinical overuse from a new perspective. Dr. Cho and his colleagues have turned the traditional morbidity and mortality conference on its head by addressing overuse as a medical error and using the conference as a forum to discuss which practical steps should be taken to improve quality of care while avoiding overuse of tests.

In this video interview, Dr. Cho – along with other key members of the OCCAM’s team – discuss the initiative’s inception, the importance of workgroups in implementing quality improvement initiatives from the ground up, and how to advance the conversation to define high-value care.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

dchitnis@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
VIDEO: High-value care: The OCCAM’s initiative
Display Headline
VIDEO: High-value care: The OCCAM’s initiative
Legacy Keywords
high, value, care, OCCAM, Mt. Sinai, Cho, quality, improvement
Legacy Keywords
high, value, care, OCCAM, Mt. Sinai, Cho, quality, improvement
Article Source

PURLs Copyright

Inside the Article

ICD-10 testers recommend certified coders, lighter loads for October

Article Type
Changed
Display Headline
ICD-10 testers recommend certified coders, lighter loads for October

The advice from those who have already tried coding with ICD-10? Hire a certified coder if you don’t have one on staff already.

“If a physician office doesn’t have a certified coder, it should,” according to Penny Osmon Bahr, director of Avastone Health Solutions, who took part in the final International Classification of Disease, tenth revision, “end-to-end” test conducted by the Centers for Medicare & Medicaid in July. “That’s just plain and simple.”

Ms. Osmon Bahr described coding as “the pulse point of how data are really consumed,” whether via ICD-10 or part of value-based contracting, research on patient outcomes, or incentives being driven by the CMS. “It takes coders to ensure that the data that is going out truly represents your patient population and the patients that you are treating.”

©DWP/Fotolia.com

Some physician practices “haven’t invested in education for staff to become knowledgeable in coding or certified in coding. That could be a struggle as the world continues to evolve.”

Another bit of advice: Scale back on the number of patient visits you book in October. That will give extra time to learn and incorporate ICD-10 into work flows.

“One of the things that we’ve encouraged our physicians to do is they need to lighten their schedules in October to prepare for ICD-10 to make sure they are completing the documentation that’s needed and coding with the current codes,” Lori Albano, manager of EDI development and support with practice management and EHR software vendor Nextgen Healthcare of Atlanta. “So maybe the first 2 weeks they lighten [appointments] by 20%” and then set up a specific schedule to ramp back up to full capacity.

Ms. Albano also recommended a focused approach to learning new codes to help avoid being overwhelmed.

“Take the top 50-100 ICD-9 codes that you currently use and become familiar with those ICD-10 codes and the documentation required to support them,” she said. “Start documenting on that level now.”

Ms. Osmon Bahr also stressed thorough documentation.

“You always want to tell the most specific story about your patient that you can,” she said, based on the greater number and specificity of the ICD-10 code set.

Ms. Osmon Bahr and Ms. Albano both spoke positively of the experience of testing and said that CMS appears ready to make the transition. The agency announced on Aug. 28 that its final round of end-to-end testing found no new issues and that no CMS front-end issues led to claims rejections. Previous issues in prior test rounds have been resolved, the agency noted.

gtwachtman@frontlinemedcom.com

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
ICD-10, Medicare, CMS
Sections
Author and Disclosure Information

Author and Disclosure Information

Related Articles

The advice from those who have already tried coding with ICD-10? Hire a certified coder if you don’t have one on staff already.

“If a physician office doesn’t have a certified coder, it should,” according to Penny Osmon Bahr, director of Avastone Health Solutions, who took part in the final International Classification of Disease, tenth revision, “end-to-end” test conducted by the Centers for Medicare & Medicaid in July. “That’s just plain and simple.”

Ms. Osmon Bahr described coding as “the pulse point of how data are really consumed,” whether via ICD-10 or part of value-based contracting, research on patient outcomes, or incentives being driven by the CMS. “It takes coders to ensure that the data that is going out truly represents your patient population and the patients that you are treating.”

©DWP/Fotolia.com

Some physician practices “haven’t invested in education for staff to become knowledgeable in coding or certified in coding. That could be a struggle as the world continues to evolve.”

Another bit of advice: Scale back on the number of patient visits you book in October. That will give extra time to learn and incorporate ICD-10 into work flows.

“One of the things that we’ve encouraged our physicians to do is they need to lighten their schedules in October to prepare for ICD-10 to make sure they are completing the documentation that’s needed and coding with the current codes,” Lori Albano, manager of EDI development and support with practice management and EHR software vendor Nextgen Healthcare of Atlanta. “So maybe the first 2 weeks they lighten [appointments] by 20%” and then set up a specific schedule to ramp back up to full capacity.

Ms. Albano also recommended a focused approach to learning new codes to help avoid being overwhelmed.

“Take the top 50-100 ICD-9 codes that you currently use and become familiar with those ICD-10 codes and the documentation required to support them,” she said. “Start documenting on that level now.”

Ms. Osmon Bahr also stressed thorough documentation.

“You always want to tell the most specific story about your patient that you can,” she said, based on the greater number and specificity of the ICD-10 code set.

Ms. Osmon Bahr and Ms. Albano both spoke positively of the experience of testing and said that CMS appears ready to make the transition. The agency announced on Aug. 28 that its final round of end-to-end testing found no new issues and that no CMS front-end issues led to claims rejections. Previous issues in prior test rounds have been resolved, the agency noted.

gtwachtman@frontlinemedcom.com

The advice from those who have already tried coding with ICD-10? Hire a certified coder if you don’t have one on staff already.

“If a physician office doesn’t have a certified coder, it should,” according to Penny Osmon Bahr, director of Avastone Health Solutions, who took part in the final International Classification of Disease, tenth revision, “end-to-end” test conducted by the Centers for Medicare & Medicaid in July. “That’s just plain and simple.”

Ms. Osmon Bahr described coding as “the pulse point of how data are really consumed,” whether via ICD-10 or part of value-based contracting, research on patient outcomes, or incentives being driven by the CMS. “It takes coders to ensure that the data that is going out truly represents your patient population and the patients that you are treating.”

©DWP/Fotolia.com

Some physician practices “haven’t invested in education for staff to become knowledgeable in coding or certified in coding. That could be a struggle as the world continues to evolve.”

Another bit of advice: Scale back on the number of patient visits you book in October. That will give extra time to learn and incorporate ICD-10 into work flows.

“One of the things that we’ve encouraged our physicians to do is they need to lighten their schedules in October to prepare for ICD-10 to make sure they are completing the documentation that’s needed and coding with the current codes,” Lori Albano, manager of EDI development and support with practice management and EHR software vendor Nextgen Healthcare of Atlanta. “So maybe the first 2 weeks they lighten [appointments] by 20%” and then set up a specific schedule to ramp back up to full capacity.

Ms. Albano also recommended a focused approach to learning new codes to help avoid being overwhelmed.

“Take the top 50-100 ICD-9 codes that you currently use and become familiar with those ICD-10 codes and the documentation required to support them,” she said. “Start documenting on that level now.”

Ms. Osmon Bahr also stressed thorough documentation.

“You always want to tell the most specific story about your patient that you can,” she said, based on the greater number and specificity of the ICD-10 code set.

Ms. Osmon Bahr and Ms. Albano both spoke positively of the experience of testing and said that CMS appears ready to make the transition. The agency announced on Aug. 28 that its final round of end-to-end testing found no new issues and that no CMS front-end issues led to claims rejections. Previous issues in prior test rounds have been resolved, the agency noted.

gtwachtman@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
ICD-10 testers recommend certified coders, lighter loads for October
Display Headline
ICD-10 testers recommend certified coders, lighter loads for October
Legacy Keywords
ICD-10, Medicare, CMS
Legacy Keywords
ICD-10, Medicare, CMS
Sections
Article Source

PURLs Copyright

Inside the Article

White board in the OR adds a layer of safety

Article Type
Changed
Display Headline
White board in the OR adds a layer of safety

NEW YORK – Displaying a low-tech, low-cost white board in the operating room during the “time out” before surgery can significantly improve memory retention among members of the surgical team, a new study suggests.

“We found that providing a white board that you can buy at any office supply store gives a visual stimulus on top of the verbal stimulus [that] improves retention of important information,” Dr. Aryan Meknat, the study author, said at the annual Minimally Invasive Surgery Week.

A surgical pause or “time out” performed before any operative procedure is a major component of the Joint Commission’s Universal Protocol to prevent wrong site, wrong procedure, and wrong person surgery. Retention of information presented during the surgical pause is essential, at the beginning of the case and for the duration of the procedure, he said.

During the study, surgical teams were randomly divided into two groups: in the first group, 30 team members were given information verbally during the surgical pause; while a second group of 29 team members was provided with verbal information that was read from the white board. The white board was displayed in the operating room throughout the surgical procedure for the second group.

After the conclusion of the procedure, the white board was removed and both groups were given a short written questionnaire. Each team was tested only once in order to keep the study blinded. Also, participants had no prior knowledge that they would be tested after the procedure.

Study participants were asked to recall several facts about the patient, including the patient’s first and last name, age, sex, weight, site of IV placement, allergies, medications, relation of accompanying guardian, and the signature on the consent form.

Team members in the first study group answered a total of 300 questions, and 200 questions (66.7%) were correctly answered. Participants in the second group – which used the white board – answered 290 questions, and 239 (82.4%) were correctly answered. The white board group had a 23.6% overall increase in correctly answered questions. The difference between retention in the two groups was statistically significant (P less than .05) in every category tested.

“These findings apply to operating rooms everywhere, especially in cases where there may be long delays before starting the procedure, changes in anesthesia midcase, situations where two procedures are scheduled in one patient, or in intraoperative emergency situations. We need to be sure that the surgical team retains information, as well as [listens] to verbal instructions,” said Dr. Meknat of MobiSurg, a mobile surgical unit based in Laguna Hills, Calif.

Dr. Meknat reported having no financial disclosures.

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
white board, surgery
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

NEW YORK – Displaying a low-tech, low-cost white board in the operating room during the “time out” before surgery can significantly improve memory retention among members of the surgical team, a new study suggests.

“We found that providing a white board that you can buy at any office supply store gives a visual stimulus on top of the verbal stimulus [that] improves retention of important information,” Dr. Aryan Meknat, the study author, said at the annual Minimally Invasive Surgery Week.

A surgical pause or “time out” performed before any operative procedure is a major component of the Joint Commission’s Universal Protocol to prevent wrong site, wrong procedure, and wrong person surgery. Retention of information presented during the surgical pause is essential, at the beginning of the case and for the duration of the procedure, he said.

During the study, surgical teams were randomly divided into two groups: in the first group, 30 team members were given information verbally during the surgical pause; while a second group of 29 team members was provided with verbal information that was read from the white board. The white board was displayed in the operating room throughout the surgical procedure for the second group.

After the conclusion of the procedure, the white board was removed and both groups were given a short written questionnaire. Each team was tested only once in order to keep the study blinded. Also, participants had no prior knowledge that they would be tested after the procedure.

Study participants were asked to recall several facts about the patient, including the patient’s first and last name, age, sex, weight, site of IV placement, allergies, medications, relation of accompanying guardian, and the signature on the consent form.

Team members in the first study group answered a total of 300 questions, and 200 questions (66.7%) were correctly answered. Participants in the second group – which used the white board – answered 290 questions, and 239 (82.4%) were correctly answered. The white board group had a 23.6% overall increase in correctly answered questions. The difference between retention in the two groups was statistically significant (P less than .05) in every category tested.

“These findings apply to operating rooms everywhere, especially in cases where there may be long delays before starting the procedure, changes in anesthesia midcase, situations where two procedures are scheduled in one patient, or in intraoperative emergency situations. We need to be sure that the surgical team retains information, as well as [listens] to verbal instructions,” said Dr. Meknat of MobiSurg, a mobile surgical unit based in Laguna Hills, Calif.

Dr. Meknat reported having no financial disclosures.

NEW YORK – Displaying a low-tech, low-cost white board in the operating room during the “time out” before surgery can significantly improve memory retention among members of the surgical team, a new study suggests.

“We found that providing a white board that you can buy at any office supply store gives a visual stimulus on top of the verbal stimulus [that] improves retention of important information,” Dr. Aryan Meknat, the study author, said at the annual Minimally Invasive Surgery Week.

A surgical pause or “time out” performed before any operative procedure is a major component of the Joint Commission’s Universal Protocol to prevent wrong site, wrong procedure, and wrong person surgery. Retention of information presented during the surgical pause is essential, at the beginning of the case and for the duration of the procedure, he said.

During the study, surgical teams were randomly divided into two groups: in the first group, 30 team members were given information verbally during the surgical pause; while a second group of 29 team members was provided with verbal information that was read from the white board. The white board was displayed in the operating room throughout the surgical procedure for the second group.

After the conclusion of the procedure, the white board was removed and both groups were given a short written questionnaire. Each team was tested only once in order to keep the study blinded. Also, participants had no prior knowledge that they would be tested after the procedure.

Study participants were asked to recall several facts about the patient, including the patient’s first and last name, age, sex, weight, site of IV placement, allergies, medications, relation of accompanying guardian, and the signature on the consent form.

Team members in the first study group answered a total of 300 questions, and 200 questions (66.7%) were correctly answered. Participants in the second group – which used the white board – answered 290 questions, and 239 (82.4%) were correctly answered. The white board group had a 23.6% overall increase in correctly answered questions. The difference between retention in the two groups was statistically significant (P less than .05) in every category tested.

“These findings apply to operating rooms everywhere, especially in cases where there may be long delays before starting the procedure, changes in anesthesia midcase, situations where two procedures are scheduled in one patient, or in intraoperative emergency situations. We need to be sure that the surgical team retains information, as well as [listens] to verbal instructions,” said Dr. Meknat of MobiSurg, a mobile surgical unit based in Laguna Hills, Calif.

Dr. Meknat reported having no financial disclosures.

References

References

Publications
Publications
Topics
Article Type
Display Headline
White board in the OR adds a layer of safety
Display Headline
White board in the OR adds a layer of safety
Legacy Keywords
white board, surgery
Legacy Keywords
white board, surgery
Sections
Article Source

AT MINIMALLY INVASIVE SURGERY WEEK

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Displaying a white board during the “time out” before surgery significantly improves memory retention.

Major finding: Surgical team members using a white board achieved a 23.6% improvement in recall of patient information after surgery.

Data source: A prospective blinded study of 59 surgical team members.

Disclosures: Dr. Meknat reported having no financial disclosures.

PQRS: Window is short to dispute the 2% pay cut

Article Type
Changed
Display Headline
PQRS: Window is short to dispute the 2% pay cut

Assessments are complete, and the Centers for Medicare & Medicaid Services has determined which physician practices will face a pay cut – officially, a “downward payment adjustment” – for failing to comply with the Physician Quality Reporting System (PQRS). Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves a cut in 2016.

The pay cut will apply to individual eligible practitioners and PQRS group practices that did not satisfactorily report data on quality measures in 2014. The 2% cut will be applied to all Part B covered services, according to a Sept. 9 CMS announcement.

 

©Jupiterimages/thinkstockphotos.com

To learn whether they are subject to the cut, physicians can review their 2014 PQRS feedback reports, which became available Sept. 8. The reports apply to doctors who submitted quality data in calendar year 2014. Feedback reports for 2015 will be available approximately this time next year.

To challenge PQRS determinations, physicians can submit an informal review between Sept. 9 and Nov. 9 and request that the CMS reevaluate incentive eligibility and adjustment determinations. Those requests can be made through the quality reporting portal. Physicians who request a review will be contacted via email of a final decision by the CMS within 90 days of their request. All decisions will be final and there will be no further review or appeal, according to the CMS.

It should not be surprising that physicians who did not satisfactorily comply with PQRS will see a 2% pay cut next year, said David Harlow, a health law and policy attorney based in Newton, Mass. What’s unusual, however, is that the informal review process does not include an avenue for an independent evaluation, Mr. Harlow said.

“It’s CMS reviewing a CMS decision,” he said in an interview. “From a provider perspective, there might be some skepticism about the independence of that review. CMS says this is not something that is subject to further administrative or judicial review. So there’s not an appeal.”

Mr. Harlow said that he would not be surprised if physician organizations advocate for further judicial relief in the process. CMS has previously provided avenues for administrative or judicial appeals of its decisions in other programs, he noted.

In its announcement, the agency outlined the ways in which physicians could have avoided the coming pay cut. This included reporting nine measures across three domains for 50% of Medicare patients, completing the GPRO Web Interface, or reporting at least one registry measures group for 20 patients, at least 11 of whom were Medicare Part B patients. Additionally, doctors could have reported three measures across one domain for 50% of Medicare patients, or satisfactorily participated in a qualified clinical data registry.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Publications
Topics
Legacy Keywords
CMS, Physician Quality Reporting System, PQRS
Sections

Assessments are complete, and the Centers for Medicare & Medicaid Services has determined which physician practices will face a pay cut – officially, a “downward payment adjustment” – for failing to comply with the Physician Quality Reporting System (PQRS). Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves a cut in 2016.

The pay cut will apply to individual eligible practitioners and PQRS group practices that did not satisfactorily report data on quality measures in 2014. The 2% cut will be applied to all Part B covered services, according to a Sept. 9 CMS announcement.

 

©Jupiterimages/thinkstockphotos.com

To learn whether they are subject to the cut, physicians can review their 2014 PQRS feedback reports, which became available Sept. 8. The reports apply to doctors who submitted quality data in calendar year 2014. Feedback reports for 2015 will be available approximately this time next year.

To challenge PQRS determinations, physicians can submit an informal review between Sept. 9 and Nov. 9 and request that the CMS reevaluate incentive eligibility and adjustment determinations. Those requests can be made through the quality reporting portal. Physicians who request a review will be contacted via email of a final decision by the CMS within 90 days of their request. All decisions will be final and there will be no further review or appeal, according to the CMS.

It should not be surprising that physicians who did not satisfactorily comply with PQRS will see a 2% pay cut next year, said David Harlow, a health law and policy attorney based in Newton, Mass. What’s unusual, however, is that the informal review process does not include an avenue for an independent evaluation, Mr. Harlow said.

“It’s CMS reviewing a CMS decision,” he said in an interview. “From a provider perspective, there might be some skepticism about the independence of that review. CMS says this is not something that is subject to further administrative or judicial review. So there’s not an appeal.”

Mr. Harlow said that he would not be surprised if physician organizations advocate for further judicial relief in the process. CMS has previously provided avenues for administrative or judicial appeals of its decisions in other programs, he noted.

In its announcement, the agency outlined the ways in which physicians could have avoided the coming pay cut. This included reporting nine measures across three domains for 50% of Medicare patients, completing the GPRO Web Interface, or reporting at least one registry measures group for 20 patients, at least 11 of whom were Medicare Part B patients. Additionally, doctors could have reported three measures across one domain for 50% of Medicare patients, or satisfactorily participated in a qualified clinical data registry.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Assessments are complete, and the Centers for Medicare & Medicaid Services has determined which physician practices will face a pay cut – officially, a “downward payment adjustment” – for failing to comply with the Physician Quality Reporting System (PQRS). Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves a cut in 2016.

The pay cut will apply to individual eligible practitioners and PQRS group practices that did not satisfactorily report data on quality measures in 2014. The 2% cut will be applied to all Part B covered services, according to a Sept. 9 CMS announcement.

 

©Jupiterimages/thinkstockphotos.com

To learn whether they are subject to the cut, physicians can review their 2014 PQRS feedback reports, which became available Sept. 8. The reports apply to doctors who submitted quality data in calendar year 2014. Feedback reports for 2015 will be available approximately this time next year.

To challenge PQRS determinations, physicians can submit an informal review between Sept. 9 and Nov. 9 and request that the CMS reevaluate incentive eligibility and adjustment determinations. Those requests can be made through the quality reporting portal. Physicians who request a review will be contacted via email of a final decision by the CMS within 90 days of their request. All decisions will be final and there will be no further review or appeal, according to the CMS.

It should not be surprising that physicians who did not satisfactorily comply with PQRS will see a 2% pay cut next year, said David Harlow, a health law and policy attorney based in Newton, Mass. What’s unusual, however, is that the informal review process does not include an avenue for an independent evaluation, Mr. Harlow said.

“It’s CMS reviewing a CMS decision,” he said in an interview. “From a provider perspective, there might be some skepticism about the independence of that review. CMS says this is not something that is subject to further administrative or judicial review. So there’s not an appeal.”

Mr. Harlow said that he would not be surprised if physician organizations advocate for further judicial relief in the process. CMS has previously provided avenues for administrative or judicial appeals of its decisions in other programs, he noted.

In its announcement, the agency outlined the ways in which physicians could have avoided the coming pay cut. This included reporting nine measures across three domains for 50% of Medicare patients, completing the GPRO Web Interface, or reporting at least one registry measures group for 20 patients, at least 11 of whom were Medicare Part B patients. Additionally, doctors could have reported three measures across one domain for 50% of Medicare patients, or satisfactorily participated in a qualified clinical data registry.

agallegos@frontlinemedcom.com

On Twitter @legal_med

Publications
Publications
Topics
Article Type
Display Headline
PQRS: Window is short to dispute the 2% pay cut
Display Headline
PQRS: Window is short to dispute the 2% pay cut
Legacy Keywords
CMS, Physician Quality Reporting System, PQRS
Legacy Keywords
CMS, Physician Quality Reporting System, PQRS
Sections
Disallow All Ads
Alternative CME

Virtual learning platform effective in teaching suturing

Article Type
Changed
Display Headline
Virtual learning platform effective in teaching suturing

NEW YORK – Virtual learning of laparoscopic surgical skills is now possible and appears to be as successful as direct mentoring through an in-person teaching course, according to a pilot study of 16 medical students and residents naive to laparoscopy.

Suturing skills were equivalent in the group mentored directly, compared with those who learned how to suture in a virtual course using a telementoring program called Top Gun Surgeon. Suturing was evaluated based on time, skill, and errors.

Dr. James C. Rosser Jr.

“Our preliminary data suggest there is no difference between in-person transferring of suturing skills versus telementoring. Top Gun Surgeon is a new, cost-effective telementoring program, using telecommunications to guide surgeons and teach them skills from afar. It is a great extender, expanding access to available mentors, and increasing access to surgical training,” said Dr. James C. Rosser Jr., a surgeon at Celebration Hospital in Florida and developer of the original Top Gun Surgeon training program, which recently added a telementoring component.

Future studies are planned with a group of 75 surgeons to validate telementoring as an effective method of teaching laparoscopic surgical skills. Participants will go through a series of drills based on the Top Gun Surgeons to increase their speed and competence.

Improving skills such as suturing is critical for the field, according to Dr. Rosser.

“Adoption of advanced laparoscopic procedures has been abysmal in the U.S.,” he said at the annual Minimally Invasive Surgery Week. “Surgeons need to adopt advanced skills required for minimally invasive surgery, starting with suturing.”

“Our data show that only 18% of self-proclaimed advanced laparoscopy surgeons can tie a knot in 10 minutes. You can take the Top Gun course and learn how to do this in 12 hours with telementoring, or teach yourself in 350 hours,” he said in an interview.

The standard setup for telementoring involves a downloadable iBook, two webcams, two tripods, a headset, and a USB extender. This platform costs about $322 to acquire, according to Dr. Rosser.

“A robot costs $100,000,” he said. “It’s not feasible to buy a robot for every training station.”

The suturing training course is $1,500 per physician and can be ordered through stealthlearningcompany.com.

The potential advantages of telementoring include expanded access to available mentors, increased access to surgical training, multiplication of the workforce, and improved novice performance, according to Dr. Rosser. Another potential benefit is the cost effectiveness of the program, provided the transfer of skills is proven to be equally effective to in-person training in larger studies. With the virtual program, a single mentor can monitor multiple positions.

More than 7,500 surgeons have gone through the Top Gun Surgeon training program since its launch in 1992. The telementoring component is new.

“This is the first time we have done a study at a high academic level where skills are transferred virtually by telementoring. We saw equivalent transfer of skills using the direct mentoring method and telementoring,” Dr. Rosser said. “We believe that this technology can be transferred to other industries. It’s groundbreaking to learn new skills without traveling.”

Dr. Paul Wetter, chairman of the Society of Laparoendoscopic Surgeons, said the virtual course has a lot of appeal.

“In this era of time constraints for the medical profession, being able to take a course and practice on a simulator where you are, instead of having to travel to meetings, and the opportunity to learn at your own pace and go back to review specifics you may be unsure of, will allow laparoscopic surgeons to ‘warm up’ their skill set,” Dr. Wetter said. “Many studies show improved surgical outcomes with ‘warming up.’ ”

The Society of Laparoendoscopic Surgeons – in collaboration with Dr. Rosser – developed the new iBook teaching platform. The Society is currently developing a CME course for accreditation using the new platform.

“This program will help solve the difficulties related to time and logistics and improve laparoscopic surgery skill sets, which is linked to patient safety and outcomes,” Dr. Wetter said.

The pilot study was sponsored by Karl Storz, a medical device manufacturer.

References

Meeting/Event
Author and Disclosure Information

Publications
Topics
Legacy Keywords
minimally invasive surgery, top gun, suturing
Sections
Author and Disclosure Information

Author and Disclosure Information

Meeting/Event
Meeting/Event

NEW YORK – Virtual learning of laparoscopic surgical skills is now possible and appears to be as successful as direct mentoring through an in-person teaching course, according to a pilot study of 16 medical students and residents naive to laparoscopy.

Suturing skills were equivalent in the group mentored directly, compared with those who learned how to suture in a virtual course using a telementoring program called Top Gun Surgeon. Suturing was evaluated based on time, skill, and errors.

Dr. James C. Rosser Jr.

“Our preliminary data suggest there is no difference between in-person transferring of suturing skills versus telementoring. Top Gun Surgeon is a new, cost-effective telementoring program, using telecommunications to guide surgeons and teach them skills from afar. It is a great extender, expanding access to available mentors, and increasing access to surgical training,” said Dr. James C. Rosser Jr., a surgeon at Celebration Hospital in Florida and developer of the original Top Gun Surgeon training program, which recently added a telementoring component.

Future studies are planned with a group of 75 surgeons to validate telementoring as an effective method of teaching laparoscopic surgical skills. Participants will go through a series of drills based on the Top Gun Surgeons to increase their speed and competence.

Improving skills such as suturing is critical for the field, according to Dr. Rosser.

“Adoption of advanced laparoscopic procedures has been abysmal in the U.S.,” he said at the annual Minimally Invasive Surgery Week. “Surgeons need to adopt advanced skills required for minimally invasive surgery, starting with suturing.”

“Our data show that only 18% of self-proclaimed advanced laparoscopy surgeons can tie a knot in 10 minutes. You can take the Top Gun course and learn how to do this in 12 hours with telementoring, or teach yourself in 350 hours,” he said in an interview.

The standard setup for telementoring involves a downloadable iBook, two webcams, two tripods, a headset, and a USB extender. This platform costs about $322 to acquire, according to Dr. Rosser.

“A robot costs $100,000,” he said. “It’s not feasible to buy a robot for every training station.”

The suturing training course is $1,500 per physician and can be ordered through stealthlearningcompany.com.

The potential advantages of telementoring include expanded access to available mentors, increased access to surgical training, multiplication of the workforce, and improved novice performance, according to Dr. Rosser. Another potential benefit is the cost effectiveness of the program, provided the transfer of skills is proven to be equally effective to in-person training in larger studies. With the virtual program, a single mentor can monitor multiple positions.

More than 7,500 surgeons have gone through the Top Gun Surgeon training program since its launch in 1992. The telementoring component is new.

“This is the first time we have done a study at a high academic level where skills are transferred virtually by telementoring. We saw equivalent transfer of skills using the direct mentoring method and telementoring,” Dr. Rosser said. “We believe that this technology can be transferred to other industries. It’s groundbreaking to learn new skills without traveling.”

Dr. Paul Wetter, chairman of the Society of Laparoendoscopic Surgeons, said the virtual course has a lot of appeal.

“In this era of time constraints for the medical profession, being able to take a course and practice on a simulator where you are, instead of having to travel to meetings, and the opportunity to learn at your own pace and go back to review specifics you may be unsure of, will allow laparoscopic surgeons to ‘warm up’ their skill set,” Dr. Wetter said. “Many studies show improved surgical outcomes with ‘warming up.’ ”

The Society of Laparoendoscopic Surgeons – in collaboration with Dr. Rosser – developed the new iBook teaching platform. The Society is currently developing a CME course for accreditation using the new platform.

“This program will help solve the difficulties related to time and logistics and improve laparoscopic surgery skill sets, which is linked to patient safety and outcomes,” Dr. Wetter said.

The pilot study was sponsored by Karl Storz, a medical device manufacturer.

NEW YORK – Virtual learning of laparoscopic surgical skills is now possible and appears to be as successful as direct mentoring through an in-person teaching course, according to a pilot study of 16 medical students and residents naive to laparoscopy.

Suturing skills were equivalent in the group mentored directly, compared with those who learned how to suture in a virtual course using a telementoring program called Top Gun Surgeon. Suturing was evaluated based on time, skill, and errors.

Dr. James C. Rosser Jr.

“Our preliminary data suggest there is no difference between in-person transferring of suturing skills versus telementoring. Top Gun Surgeon is a new, cost-effective telementoring program, using telecommunications to guide surgeons and teach them skills from afar. It is a great extender, expanding access to available mentors, and increasing access to surgical training,” said Dr. James C. Rosser Jr., a surgeon at Celebration Hospital in Florida and developer of the original Top Gun Surgeon training program, which recently added a telementoring component.

Future studies are planned with a group of 75 surgeons to validate telementoring as an effective method of teaching laparoscopic surgical skills. Participants will go through a series of drills based on the Top Gun Surgeons to increase their speed and competence.

Improving skills such as suturing is critical for the field, according to Dr. Rosser.

“Adoption of advanced laparoscopic procedures has been abysmal in the U.S.,” he said at the annual Minimally Invasive Surgery Week. “Surgeons need to adopt advanced skills required for minimally invasive surgery, starting with suturing.”

“Our data show that only 18% of self-proclaimed advanced laparoscopy surgeons can tie a knot in 10 minutes. You can take the Top Gun course and learn how to do this in 12 hours with telementoring, or teach yourself in 350 hours,” he said in an interview.

The standard setup for telementoring involves a downloadable iBook, two webcams, two tripods, a headset, and a USB extender. This platform costs about $322 to acquire, according to Dr. Rosser.

“A robot costs $100,000,” he said. “It’s not feasible to buy a robot for every training station.”

The suturing training course is $1,500 per physician and can be ordered through stealthlearningcompany.com.

The potential advantages of telementoring include expanded access to available mentors, increased access to surgical training, multiplication of the workforce, and improved novice performance, according to Dr. Rosser. Another potential benefit is the cost effectiveness of the program, provided the transfer of skills is proven to be equally effective to in-person training in larger studies. With the virtual program, a single mentor can monitor multiple positions.

More than 7,500 surgeons have gone through the Top Gun Surgeon training program since its launch in 1992. The telementoring component is new.

“This is the first time we have done a study at a high academic level where skills are transferred virtually by telementoring. We saw equivalent transfer of skills using the direct mentoring method and telementoring,” Dr. Rosser said. “We believe that this technology can be transferred to other industries. It’s groundbreaking to learn new skills without traveling.”

Dr. Paul Wetter, chairman of the Society of Laparoendoscopic Surgeons, said the virtual course has a lot of appeal.

“In this era of time constraints for the medical profession, being able to take a course and practice on a simulator where you are, instead of having to travel to meetings, and the opportunity to learn at your own pace and go back to review specifics you may be unsure of, will allow laparoscopic surgeons to ‘warm up’ their skill set,” Dr. Wetter said. “Many studies show improved surgical outcomes with ‘warming up.’ ”

The Society of Laparoendoscopic Surgeons – in collaboration with Dr. Rosser – developed the new iBook teaching platform. The Society is currently developing a CME course for accreditation using the new platform.

“This program will help solve the difficulties related to time and logistics and improve laparoscopic surgery skill sets, which is linked to patient safety and outcomes,” Dr. Wetter said.

The pilot study was sponsored by Karl Storz, a medical device manufacturer.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Virtual learning platform effective in teaching suturing
Display Headline
Virtual learning platform effective in teaching suturing
Legacy Keywords
minimally invasive surgery, top gun, suturing
Legacy Keywords
minimally invasive surgery, top gun, suturing
Sections
Article Source

AT MINIMALLY INVASIVE SURGERY WEEK

PURLs Copyright

Inside the Article

Vitals

Key clinical point: A virtual learning program lets surgeons acquire and polish their skills.

Major finding: Suturing skills appear to be equivalent if taught directly by an in-person mentor or acquired via a telementoring program.

Data source: A pilot study of 16 medical students and residents naive to laparoscopy.

Disclosures: The study was sponsored by Karl Storz, a medical device manufacturer. Dr. Rosser is the developer of the Top Gun Surgeon program.

New cartilage, better function with stem cells for knee OA

Article Type
Changed
Display Headline
New cartilage, better function with stem cells for knee OA

Mesenchymal stem cell transplants appeared to regenerate cartilage and improve clinical outcomes after 2 years in patients with knee osteoarthritis in a small South Korean study.

There were 24 treated knees among the 11 men and 9 women in the study, whose average age was 58 years and mean body mass index was 26.6 kg/m2.

©decade3d/Thinkstock.com

At baseline, 21 lesions (87.5%) were grade 2 or 3 on the MRI Osteoarthritis Knee Score scale for size of cartilage-loss area, and 23 lesions (95.9%) were grade 2 or 3 for percentage of full-thickness cartilage loss. A grade of 2-3 indicates moderate to severe disease.

At MRI follow-up 2 years after transplant, only five lesions (20.8%) were grade 2 or 3 for cartilage-loss area and five were grade 2 or 3 for full-thickness cartilage loss, reported Dr. Yong Sang Kim of the Yonsei Sarang Hospital in Seoul and his associates (Osteoarthritis Cartilage. 2015. doi: 10.1016/j.joca.2015.08.009).

There were clinical improvements, too. At baseline, the mean International Knee Documentation Committee score improved from 38.7 at baseline to 67.3 at follow-up and the mean Tegner activity scale score improved from 2.5 at baseline to 3.9 at follow-up. The results were all statistically significant and independent of age, sex, body mass index, and size and location of the cartilage lesions.

“This study showed encouraging clinical outcomes of [mesenchymal stem cell] implantation with fibrin glue as a scaffold in OA knees,” and it adds to the growing body of literature supporting mesenchymal stem cells (MSCs) in osteoarthritis. “MSC implantation with fibrin glue as a scaffold seems to be effective for repairing cartilage lesions in OA knees,” the investigators wrote.

The cells were derived from fat liposuctioned from the subjects’ buttocks and delivered to their damaged knees in a fibrinogen-thrombin gel under arthroscopic guidance. The cartilage lesions, which were most often on the medial femoral condyle, were debrided beforehand. Patients’ knees were immobilized for 2 weeks after transplant. Weight bearing was allowed at 4 weeks, and sports at 3 months.

It’s not fully known why MSCs help knee OA. Perhaps they release factors that stimulate cartilage formation by resident chondrocytes or other cells in the joint, and inhibit joint inflammation. The investigators derived their cells from fat – instead of bone marrow – because stem cells from fat are easier to get, easy to purify, and may be more chondrogenic. Fat is also richer in stem cells than marrow.

The next step is to identify predictors of good outcomes. “Patient characteristics or cartilage lesion variables may serve as important selection criteria for stem cell–based repair strategies,” Dr. Kim and his associates said.

The researchers had no disclosures.

aotto@frontlinemedcom.com

References

Click for Credit Link
Author and Disclosure Information

Publications
Topics
Click for Credit Link
Click for Credit Link
Author and Disclosure Information

Author and Disclosure Information

Mesenchymal stem cell transplants appeared to regenerate cartilage and improve clinical outcomes after 2 years in patients with knee osteoarthritis in a small South Korean study.

There were 24 treated knees among the 11 men and 9 women in the study, whose average age was 58 years and mean body mass index was 26.6 kg/m2.

©decade3d/Thinkstock.com

At baseline, 21 lesions (87.5%) were grade 2 or 3 on the MRI Osteoarthritis Knee Score scale for size of cartilage-loss area, and 23 lesions (95.9%) were grade 2 or 3 for percentage of full-thickness cartilage loss. A grade of 2-3 indicates moderate to severe disease.

At MRI follow-up 2 years after transplant, only five lesions (20.8%) were grade 2 or 3 for cartilage-loss area and five were grade 2 or 3 for full-thickness cartilage loss, reported Dr. Yong Sang Kim of the Yonsei Sarang Hospital in Seoul and his associates (Osteoarthritis Cartilage. 2015. doi: 10.1016/j.joca.2015.08.009).

There were clinical improvements, too. At baseline, the mean International Knee Documentation Committee score improved from 38.7 at baseline to 67.3 at follow-up and the mean Tegner activity scale score improved from 2.5 at baseline to 3.9 at follow-up. The results were all statistically significant and independent of age, sex, body mass index, and size and location of the cartilage lesions.

“This study showed encouraging clinical outcomes of [mesenchymal stem cell] implantation with fibrin glue as a scaffold in OA knees,” and it adds to the growing body of literature supporting mesenchymal stem cells (MSCs) in osteoarthritis. “MSC implantation with fibrin glue as a scaffold seems to be effective for repairing cartilage lesions in OA knees,” the investigators wrote.

The cells were derived from fat liposuctioned from the subjects’ buttocks and delivered to their damaged knees in a fibrinogen-thrombin gel under arthroscopic guidance. The cartilage lesions, which were most often on the medial femoral condyle, were debrided beforehand. Patients’ knees were immobilized for 2 weeks after transplant. Weight bearing was allowed at 4 weeks, and sports at 3 months.

It’s not fully known why MSCs help knee OA. Perhaps they release factors that stimulate cartilage formation by resident chondrocytes or other cells in the joint, and inhibit joint inflammation. The investigators derived their cells from fat – instead of bone marrow – because stem cells from fat are easier to get, easy to purify, and may be more chondrogenic. Fat is also richer in stem cells than marrow.

The next step is to identify predictors of good outcomes. “Patient characteristics or cartilage lesion variables may serve as important selection criteria for stem cell–based repair strategies,” Dr. Kim and his associates said.

The researchers had no disclosures.

aotto@frontlinemedcom.com

Mesenchymal stem cell transplants appeared to regenerate cartilage and improve clinical outcomes after 2 years in patients with knee osteoarthritis in a small South Korean study.

There were 24 treated knees among the 11 men and 9 women in the study, whose average age was 58 years and mean body mass index was 26.6 kg/m2.

©decade3d/Thinkstock.com

At baseline, 21 lesions (87.5%) were grade 2 or 3 on the MRI Osteoarthritis Knee Score scale for size of cartilage-loss area, and 23 lesions (95.9%) were grade 2 or 3 for percentage of full-thickness cartilage loss. A grade of 2-3 indicates moderate to severe disease.

At MRI follow-up 2 years after transplant, only five lesions (20.8%) were grade 2 or 3 for cartilage-loss area and five were grade 2 or 3 for full-thickness cartilage loss, reported Dr. Yong Sang Kim of the Yonsei Sarang Hospital in Seoul and his associates (Osteoarthritis Cartilage. 2015. doi: 10.1016/j.joca.2015.08.009).

There were clinical improvements, too. At baseline, the mean International Knee Documentation Committee score improved from 38.7 at baseline to 67.3 at follow-up and the mean Tegner activity scale score improved from 2.5 at baseline to 3.9 at follow-up. The results were all statistically significant and independent of age, sex, body mass index, and size and location of the cartilage lesions.

“This study showed encouraging clinical outcomes of [mesenchymal stem cell] implantation with fibrin glue as a scaffold in OA knees,” and it adds to the growing body of literature supporting mesenchymal stem cells (MSCs) in osteoarthritis. “MSC implantation with fibrin glue as a scaffold seems to be effective for repairing cartilage lesions in OA knees,” the investigators wrote.

The cells were derived from fat liposuctioned from the subjects’ buttocks and delivered to their damaged knees in a fibrinogen-thrombin gel under arthroscopic guidance. The cartilage lesions, which were most often on the medial femoral condyle, were debrided beforehand. Patients’ knees were immobilized for 2 weeks after transplant. Weight bearing was allowed at 4 weeks, and sports at 3 months.

It’s not fully known why MSCs help knee OA. Perhaps they release factors that stimulate cartilage formation by resident chondrocytes or other cells in the joint, and inhibit joint inflammation. The investigators derived their cells from fat – instead of bone marrow – because stem cells from fat are easier to get, easy to purify, and may be more chondrogenic. Fat is also richer in stem cells than marrow.

The next step is to identify predictors of good outcomes. “Patient characteristics or cartilage lesion variables may serve as important selection criteria for stem cell–based repair strategies,” Dr. Kim and his associates said.

The researchers had no disclosures.

aotto@frontlinemedcom.com

References

References

Publications
Publications
Topics
Article Type
Display Headline
New cartilage, better function with stem cells for knee OA
Display Headline
New cartilage, better function with stem cells for knee OA
Article Source

FROM OSTEOARTHRITIS AND CARTILAGE

PURLs Copyright

Inside the Article

Vitals

Key clinical point: Mesenchymal stem cell transplants give promising 2-year results in knee osteoarthritis, but larger studies with longer follow-up periods are needed.

Major finding: At baseline, 23 lesions (95.9%) were grade 2 or 3 for percentage of full-thickness cartilage loss; at MRI follow-up 2 years after transplant, only five lesions (20.8%) were grade 2 or 3.

Data source: A 2-year follow-up of 24 treated knees.

Disclosures: The investigators had no disclosures.

The pros and cons of novel anticoagulants

Article Type
Changed
Display Headline
The pros and cons of novel anticoagulants

Novel anticoagulants will likely replace need for vitamin K antagonists

BY MADHUKAR S. PATEL, M.D., AND ELLIOT L. CHAIKOF, M.D.

The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.1 It was not until 1941, however, while trying to understand this observation, that Campbell & Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.2 Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs), began.

Dr. Elliot Chaikof

Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice.

Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.

Pharmacologic design

The targeted drug design of NOACs provides many pharmacologic advantages. Compared to VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.3 These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs.

NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low-molecular-weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.4 As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities that may influence drug effect and clearance. Lastly, it should be mentioned that the pharmacologic benefits of NOACs apply not only from a patient perspective, but also from a health care systems standpoint, as their use may provide an opportunity to deliver more cost-effective care.

Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared to warfarin.5 Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.

Patient selection

The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs to VKAs or placebos for the management of nonvalvular atrial fibrillation and venous thromboembolism, and as adjunctive therapy for patients with acute coronary syndrome.6

Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation, where NOACs yield significant reductions in stroke, intracranial hemorrhage, and all-cause mortality compared to warfarin, while displaying variable effects with regard to gastrointestinal bleeding.6,7 In patients with VTE, NOACs have been found to have efficacy similar to that of VKAs with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.6

Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.6 Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon which class of anticoagulant to use.

Overcoming challenges

Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life threatening bleeding complications.

Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monoclonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.8 Similarly, agents such as a PER977 are currently under phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.9

 

 

Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable compared to VKAs and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.

Conclusion

Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism, where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the healthcare system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.

Dr. Patel is a research fellow and Dr. Chaikof is surgeon-in-chief, both at the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported no conflicts of interest.

References

1. J Am Vet Med Assoc. 1924;64:553-75 (See Br J Haematol 2008 Mar 18;141[6]:757-63).

2. J Biol Chem. 1941;138:21-33 (See Nutr Rev. 1974 Aug;32[8]:244-6).

3. Am Soc Hematol Educ Program. 2013;2013:464-70.

4. Eur Heart J. 2013 Jul;34(27):2094-2106.

5. Stroke. 2013 Jun;44(6):1676-81.

6. Nat Rev Cardiol. 2014 Dec;11(12):693-703.

7. Lancet. 2014 Mar 15;383(9921):955-62.

8. N Engl J Med. 2015;373(6):511-20.

9. N Engl J Med. 2014;371(22):2141-2.

What the doctor didn’t order: unintended consequences and pitfalls of NOACs

BY THOMAS WAKEFIELD, M.D., ANDREA OBI, M.D., AND DAWN COLEMAN, M.D.

Recently, several new oral anticoagulants have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once- or twice-daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute venous thromboembolism (VTE) and atrial fibrillation (AF).

Dr. Thomas Wakefield

Dabigatran and edoxaban

As with warfarin, dabigatran and edoxaban require the use of a low-molecular-weight heparin (LMWH) or unfractionated heparin “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.1 It is the only new agent that can be at least partially reversed with dialysis.2 Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).3

Rivaroxaban and apixaban

Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique among the NOACs, have been tested for extended therapy of acute DVT after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding compared to placebo.4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding compared to warfarin.6

Consequences and pitfalls with NOACs

Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels and to reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects.

With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published a recommendation7 that lists these scenarios:

• When a patient is bleeding.

• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL/min.

 

 

• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.

• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.

• Patients with deteriorating renal function.

• During perioperative management.

• During reversal of anticoagulation.

• When there is suspicion of overdose.

• Assessment of compliance in patients suffering thrombotic events while on treatment.

Currently, there exists no commercially available reversal agent for any of the NOACs and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials is lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however, drug levels were not consistently suppressed at 24 hours in 20% of the cohort.8

There are no national guidelines nor large scale studies to guide bridging NOACs for procedures. The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.9 However, this represents a double edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.

The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.

Conclusion

So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that for all the benefits, they each carry a risk of bleeding as they all target portions of the coagulation mechanism. We believe, that as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.

Dr. Wakefield is director of the Samuel and Jean Frankel Cardiovascular Center, Dr. Obi is a vascular surgery fellow, and Dr. Coleman is program director, section of vascular surgery, at the University of Michigan, Ann Arbor. They reported no conflicts of interest.

References

1. N Engl J Med. 2009;361:2342-52.

2. J Vasc Surg: Venous Lymphat Disord. 2013;1:418-26.

3. N Engl J Med. 2013;369:1406-15.

4. N Engl J Med. 2010;363:2499-2510.

5. N Engl J Med. 2013;368:699-708.

6. Arterioscler Thromb Vasc Biol. 2015;35:1056-65.

7. J Thromb Haemost. 2013;11:756-60.

8. N Engl J Med. 2015;373:511-20.

9. Curr Opin Anaesthesiol. 2014;27:409-19.

References

Author and Disclosure Information

Publications
Topics
Legacy Keywords
novel anticoagulant. DVT, NOAC
Sections
Author and Disclosure Information

Author and Disclosure Information

Novel anticoagulants will likely replace need for vitamin K antagonists

BY MADHUKAR S. PATEL, M.D., AND ELLIOT L. CHAIKOF, M.D.

The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.1 It was not until 1941, however, while trying to understand this observation, that Campbell & Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.2 Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs), began.

Dr. Elliot Chaikof

Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice.

Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.

Pharmacologic design

The targeted drug design of NOACs provides many pharmacologic advantages. Compared to VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.3 These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs.

NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low-molecular-weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.4 As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities that may influence drug effect and clearance. Lastly, it should be mentioned that the pharmacologic benefits of NOACs apply not only from a patient perspective, but also from a health care systems standpoint, as their use may provide an opportunity to deliver more cost-effective care.

Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared to warfarin.5 Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.

Patient selection

The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs to VKAs or placebos for the management of nonvalvular atrial fibrillation and venous thromboembolism, and as adjunctive therapy for patients with acute coronary syndrome.6

Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation, where NOACs yield significant reductions in stroke, intracranial hemorrhage, and all-cause mortality compared to warfarin, while displaying variable effects with regard to gastrointestinal bleeding.6,7 In patients with VTE, NOACs have been found to have efficacy similar to that of VKAs with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.6

Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.6 Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon which class of anticoagulant to use.

Overcoming challenges

Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life threatening bleeding complications.

Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monoclonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.8 Similarly, agents such as a PER977 are currently under phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.9

 

 

Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable compared to VKAs and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.

Conclusion

Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism, where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the healthcare system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.

Dr. Patel is a research fellow and Dr. Chaikof is surgeon-in-chief, both at the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported no conflicts of interest.

References

1. J Am Vet Med Assoc. 1924;64:553-75 (See Br J Haematol 2008 Mar 18;141[6]:757-63).

2. J Biol Chem. 1941;138:21-33 (See Nutr Rev. 1974 Aug;32[8]:244-6).

3. Am Soc Hematol Educ Program. 2013;2013:464-70.

4. Eur Heart J. 2013 Jul;34(27):2094-2106.

5. Stroke. 2013 Jun;44(6):1676-81.

6. Nat Rev Cardiol. 2014 Dec;11(12):693-703.

7. Lancet. 2014 Mar 15;383(9921):955-62.

8. N Engl J Med. 2015;373(6):511-20.

9. N Engl J Med. 2014;371(22):2141-2.

What the doctor didn’t order: unintended consequences and pitfalls of NOACs

BY THOMAS WAKEFIELD, M.D., ANDREA OBI, M.D., AND DAWN COLEMAN, M.D.

Recently, several new oral anticoagulants have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once- or twice-daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute venous thromboembolism (VTE) and atrial fibrillation (AF).

Dr. Thomas Wakefield

Dabigatran and edoxaban

As with warfarin, dabigatran and edoxaban require the use of a low-molecular-weight heparin (LMWH) or unfractionated heparin “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.1 It is the only new agent that can be at least partially reversed with dialysis.2 Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).3

Rivaroxaban and apixaban

Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique among the NOACs, have been tested for extended therapy of acute DVT after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding compared to placebo.4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding compared to warfarin.6

Consequences and pitfalls with NOACs

Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels and to reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects.

With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published a recommendation7 that lists these scenarios:

• When a patient is bleeding.

• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL/min.

 

 

• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.

• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.

• Patients with deteriorating renal function.

• During perioperative management.

• During reversal of anticoagulation.

• When there is suspicion of overdose.

• Assessment of compliance in patients suffering thrombotic events while on treatment.

Currently, there exists no commercially available reversal agent for any of the NOACs and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials is lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however, drug levels were not consistently suppressed at 24 hours in 20% of the cohort.8

There are no national guidelines nor large scale studies to guide bridging NOACs for procedures. The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.9 However, this represents a double edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.

The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.

Conclusion

So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that for all the benefits, they each carry a risk of bleeding as they all target portions of the coagulation mechanism. We believe, that as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.

Dr. Wakefield is director of the Samuel and Jean Frankel Cardiovascular Center, Dr. Obi is a vascular surgery fellow, and Dr. Coleman is program director, section of vascular surgery, at the University of Michigan, Ann Arbor. They reported no conflicts of interest.

References

1. N Engl J Med. 2009;361:2342-52.

2. J Vasc Surg: Venous Lymphat Disord. 2013;1:418-26.

3. N Engl J Med. 2013;369:1406-15.

4. N Engl J Med. 2010;363:2499-2510.

5. N Engl J Med. 2013;368:699-708.

6. Arterioscler Thromb Vasc Biol. 2015;35:1056-65.

7. J Thromb Haemost. 2013;11:756-60.

8. N Engl J Med. 2015;373:511-20.

9. Curr Opin Anaesthesiol. 2014;27:409-19.

Novel anticoagulants will likely replace need for vitamin K antagonists

BY MADHUKAR S. PATEL, M.D., AND ELLIOT L. CHAIKOF, M.D.

The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.1 It was not until 1941, however, while trying to understand this observation, that Campbell & Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.2 Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs), began.

Dr. Elliot Chaikof

Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice.

Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.

Pharmacologic design

The targeted drug design of NOACs provides many pharmacologic advantages. Compared to VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.3 These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs.

NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low-molecular-weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.4 As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities that may influence drug effect and clearance. Lastly, it should be mentioned that the pharmacologic benefits of NOACs apply not only from a patient perspective, but also from a health care systems standpoint, as their use may provide an opportunity to deliver more cost-effective care.

Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared to warfarin.5 Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.

Patient selection

The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs to VKAs or placebos for the management of nonvalvular atrial fibrillation and venous thromboembolism, and as adjunctive therapy for patients with acute coronary syndrome.6

Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation, where NOACs yield significant reductions in stroke, intracranial hemorrhage, and all-cause mortality compared to warfarin, while displaying variable effects with regard to gastrointestinal bleeding.6,7 In patients with VTE, NOACs have been found to have efficacy similar to that of VKAs with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.6

Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.6 Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon which class of anticoagulant to use.

Overcoming challenges

Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life threatening bleeding complications.

Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monoclonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.8 Similarly, agents such as a PER977 are currently under phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.9

 

 

Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable compared to VKAs and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.

Conclusion

Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism, where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the healthcare system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.

Dr. Patel is a research fellow and Dr. Chaikof is surgeon-in-chief, both at the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported no conflicts of interest.

References

1. J Am Vet Med Assoc. 1924;64:553-75 (See Br J Haematol 2008 Mar 18;141[6]:757-63).

2. J Biol Chem. 1941;138:21-33 (See Nutr Rev. 1974 Aug;32[8]:244-6).

3. Am Soc Hematol Educ Program. 2013;2013:464-70.

4. Eur Heart J. 2013 Jul;34(27):2094-2106.

5. Stroke. 2013 Jun;44(6):1676-81.

6. Nat Rev Cardiol. 2014 Dec;11(12):693-703.

7. Lancet. 2014 Mar 15;383(9921):955-62.

8. N Engl J Med. 2015;373(6):511-20.

9. N Engl J Med. 2014;371(22):2141-2.

What the doctor didn’t order: unintended consequences and pitfalls of NOACs

BY THOMAS WAKEFIELD, M.D., ANDREA OBI, M.D., AND DAWN COLEMAN, M.D.

Recently, several new oral anticoagulants have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once- or twice-daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute venous thromboembolism (VTE) and atrial fibrillation (AF).

Dr. Thomas Wakefield

Dabigatran and edoxaban

As with warfarin, dabigatran and edoxaban require the use of a low-molecular-weight heparin (LMWH) or unfractionated heparin “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.1 It is the only new agent that can be at least partially reversed with dialysis.2 Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).3

Rivaroxaban and apixaban

Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique among the NOACs, have been tested for extended therapy of acute DVT after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding compared to placebo.4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding compared to warfarin.6

Consequences and pitfalls with NOACs

Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels and to reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects.

With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published a recommendation7 that lists these scenarios:

• When a patient is bleeding.

• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL/min.

 

 

• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.

• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.

• Patients with deteriorating renal function.

• During perioperative management.

• During reversal of anticoagulation.

• When there is suspicion of overdose.

• Assessment of compliance in patients suffering thrombotic events while on treatment.

Currently, there exists no commercially available reversal agent for any of the NOACs and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials is lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however, drug levels were not consistently suppressed at 24 hours in 20% of the cohort.8

There are no national guidelines nor large scale studies to guide bridging NOACs for procedures. The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.9 However, this represents a double edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.

The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.

Conclusion

So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that for all the benefits, they each carry a risk of bleeding as they all target portions of the coagulation mechanism. We believe, that as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.

Dr. Wakefield is director of the Samuel and Jean Frankel Cardiovascular Center, Dr. Obi is a vascular surgery fellow, and Dr. Coleman is program director, section of vascular surgery, at the University of Michigan, Ann Arbor. They reported no conflicts of interest.

References

1. N Engl J Med. 2009;361:2342-52.

2. J Vasc Surg: Venous Lymphat Disord. 2013;1:418-26.

3. N Engl J Med. 2013;369:1406-15.

4. N Engl J Med. 2010;363:2499-2510.

5. N Engl J Med. 2013;368:699-708.

6. Arterioscler Thromb Vasc Biol. 2015;35:1056-65.

7. J Thromb Haemost. 2013;11:756-60.

8. N Engl J Med. 2015;373:511-20.

9. Curr Opin Anaesthesiol. 2014;27:409-19.

References

References

Publications
Publications
Topics
Article Type
Display Headline
The pros and cons of novel anticoagulants
Display Headline
The pros and cons of novel anticoagulants
Legacy Keywords
novel anticoagulant. DVT, NOAC
Legacy Keywords
novel anticoagulant. DVT, NOAC
Sections
Article Source

PURLs Copyright

Inside the Article

Low-volume surgeons have most complications with mesh slings

Should referral to high-volume surgeons be mandatory?
Article Type
Changed
Display Headline
Low-volume surgeons have most complications with mesh slings

The 10-year incidence of serious complications after mesh-sling surgery for stress urinary incontinence is a relatively low 3.29, but patients treated by surgeons who perform a low volume of the procedures have a 37% higher relative risk of requiring further surgery for complications, compared with patients of experienced surgeons, according to a report published online Sept. 9 in JAMA Surgery.

“These findings support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” wrote Dr. Blayne Welk of the department of surgery and the department of epidemiology and biostatistics at Western University and St. Joseph’s Health Care, London (Ont.) and his associates.

The investigators performed a population-based retrospective cohort study to determine the incidence of surgical removal or revision after a mesh-sling procedure for SUI and to examine whether there are specific risk factors for mesh-related complications. They analyzed data for 59,887 women who underwent the procedure across Ontario during a 10-year period. Median follow-up was 4.4 years.

The procedures were performed by 1,068 surgeons: 293 urologists, 625 gynecologists, and 150 unspecified clinicians. Cases were classified according to whether the surgeon performed a high or low volume of mesh-sling procedures specifically for SUI. High volume was defined as a number at or above the 75th percentile for yearly volume in the province, or more than 16 procedures per year.

Overall, 1,307 women (2.2%) required mesh removal or revision a median of 1 year after the initial surgery. The cumulative incidence of the composite outcome of removal/revision of vaginal or urethral mesh, removal of a foreign body, endoscopic treatment of a urethral foreign body or mesh encrustation, uretrolysis, or repair of a urethrovaginal fistula was 3.29 at 10 years, Dr. Welk and his associates reported. Surgical specialty had no significant effect on complication risk.

This incidence is consistent with previous report from HMOs in the United States and a meta-analysis of clinical trial results, the investigators noted (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2590). Patients of low-volume surgeons had a 37% higher relative risk of complications requiring reoperation than did patients of high-volume surgeons. In a further analysis of the data, patients of low-volume surgeons were significantly more likely to experience the composite outcome than were patients of high-volume surgeons (hazard ratio, 1.37), and, again, the difference between surgical specialties was nonsignificant.

Urologists and gynecologists have very different surgical training and day-to-day practices, the researchers noted, and as a result they hypothesized that complication rates might differ between the two groups of clinicians. But that was not proven in the findings.

“This suggests that procedure-specific knowledge and experience is important for surgery to treat SUI, rather than general operative training,” Dr. Welk and his associates wrote.

Women who underwent multiple mesh-based procedures for SUI were at highest risk for the composite endpoint. Their absolute risk for later mesh removal or revision was 4.87%.

“This novel finding should temper the enthusiasm of case series that suggest that the use of multiple synthetic slings is safe and efficacious,” the researchers wrote.

This finding is also important in light of the fact that 1,307 of the study participants underwent more than one mesh implant procedure, presumably for recurrent SUI.

This study was supported by the Ontario Ministry of Health and Long-term Care and the Academic Medical Organization of Southwestern Ontario. Dr. Welk reported receiving grant funding from Astellas Canada.

References

Body

The call to centralize complex, high-risk surgical procedures at expert centers is well known, but what about commonly performed, same-day procedures with low risks of complications, such as mesh-sling surgery for stress urinary incontinence? Must patients be referred only to high-volume surgeons?

This likely would be impractical if not impossible for a procedure that is performed so frequently. A more reasonable approach would be for low-volume surgeons to use structured proctoring and/or coaching models to develop expertise and mandatory outcomes reporting to assure high-quality care. Even though clinicians will not welcome this approach, it probably will become required in the near future and tied to reimbursements. Ultimately, surgeons should be the drivers for change and should not wait for payers or regulators to impose punitive measures.

Dr. Christian P. Meyer and Dr. Quoc-Dien Trinh are with the Center for Surgery and Public Health and the division of urologic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston. They reported having no relevant financial disclosures. These remarks are adapted from an invited commentary (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2596) accompanying Dr. Welk’s report.

Author and Disclosure Information

Publications
Topics
Legacy Keywords
SUI, incontinence, surgical mesh sling
Author and Disclosure Information

Author and Disclosure Information

Body

The call to centralize complex, high-risk surgical procedures at expert centers is well known, but what about commonly performed, same-day procedures with low risks of complications, such as mesh-sling surgery for stress urinary incontinence? Must patients be referred only to high-volume surgeons?

This likely would be impractical if not impossible for a procedure that is performed so frequently. A more reasonable approach would be for low-volume surgeons to use structured proctoring and/or coaching models to develop expertise and mandatory outcomes reporting to assure high-quality care. Even though clinicians will not welcome this approach, it probably will become required in the near future and tied to reimbursements. Ultimately, surgeons should be the drivers for change and should not wait for payers or regulators to impose punitive measures.

Dr. Christian P. Meyer and Dr. Quoc-Dien Trinh are with the Center for Surgery and Public Health and the division of urologic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston. They reported having no relevant financial disclosures. These remarks are adapted from an invited commentary (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2596) accompanying Dr. Welk’s report.

Body

The call to centralize complex, high-risk surgical procedures at expert centers is well known, but what about commonly performed, same-day procedures with low risks of complications, such as mesh-sling surgery for stress urinary incontinence? Must patients be referred only to high-volume surgeons?

This likely would be impractical if not impossible for a procedure that is performed so frequently. A more reasonable approach would be for low-volume surgeons to use structured proctoring and/or coaching models to develop expertise and mandatory outcomes reporting to assure high-quality care. Even though clinicians will not welcome this approach, it probably will become required in the near future and tied to reimbursements. Ultimately, surgeons should be the drivers for change and should not wait for payers or regulators to impose punitive measures.

Dr. Christian P. Meyer and Dr. Quoc-Dien Trinh are with the Center for Surgery and Public Health and the division of urologic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston. They reported having no relevant financial disclosures. These remarks are adapted from an invited commentary (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2596) accompanying Dr. Welk’s report.

Title
Should referral to high-volume surgeons be mandatory?
Should referral to high-volume surgeons be mandatory?

The 10-year incidence of serious complications after mesh-sling surgery for stress urinary incontinence is a relatively low 3.29, but patients treated by surgeons who perform a low volume of the procedures have a 37% higher relative risk of requiring further surgery for complications, compared with patients of experienced surgeons, according to a report published online Sept. 9 in JAMA Surgery.

“These findings support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” wrote Dr. Blayne Welk of the department of surgery and the department of epidemiology and biostatistics at Western University and St. Joseph’s Health Care, London (Ont.) and his associates.

The investigators performed a population-based retrospective cohort study to determine the incidence of surgical removal or revision after a mesh-sling procedure for SUI and to examine whether there are specific risk factors for mesh-related complications. They analyzed data for 59,887 women who underwent the procedure across Ontario during a 10-year period. Median follow-up was 4.4 years.

The procedures were performed by 1,068 surgeons: 293 urologists, 625 gynecologists, and 150 unspecified clinicians. Cases were classified according to whether the surgeon performed a high or low volume of mesh-sling procedures specifically for SUI. High volume was defined as a number at or above the 75th percentile for yearly volume in the province, or more than 16 procedures per year.

Overall, 1,307 women (2.2%) required mesh removal or revision a median of 1 year after the initial surgery. The cumulative incidence of the composite outcome of removal/revision of vaginal or urethral mesh, removal of a foreign body, endoscopic treatment of a urethral foreign body or mesh encrustation, uretrolysis, or repair of a urethrovaginal fistula was 3.29 at 10 years, Dr. Welk and his associates reported. Surgical specialty had no significant effect on complication risk.

This incidence is consistent with previous report from HMOs in the United States and a meta-analysis of clinical trial results, the investigators noted (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2590). Patients of low-volume surgeons had a 37% higher relative risk of complications requiring reoperation than did patients of high-volume surgeons. In a further analysis of the data, patients of low-volume surgeons were significantly more likely to experience the composite outcome than were patients of high-volume surgeons (hazard ratio, 1.37), and, again, the difference between surgical specialties was nonsignificant.

Urologists and gynecologists have very different surgical training and day-to-day practices, the researchers noted, and as a result they hypothesized that complication rates might differ between the two groups of clinicians. But that was not proven in the findings.

“This suggests that procedure-specific knowledge and experience is important for surgery to treat SUI, rather than general operative training,” Dr. Welk and his associates wrote.

Women who underwent multiple mesh-based procedures for SUI were at highest risk for the composite endpoint. Their absolute risk for later mesh removal or revision was 4.87%.

“This novel finding should temper the enthusiasm of case series that suggest that the use of multiple synthetic slings is safe and efficacious,” the researchers wrote.

This finding is also important in light of the fact that 1,307 of the study participants underwent more than one mesh implant procedure, presumably for recurrent SUI.

This study was supported by the Ontario Ministry of Health and Long-term Care and the Academic Medical Organization of Southwestern Ontario. Dr. Welk reported receiving grant funding from Astellas Canada.

The 10-year incidence of serious complications after mesh-sling surgery for stress urinary incontinence is a relatively low 3.29, but patients treated by surgeons who perform a low volume of the procedures have a 37% higher relative risk of requiring further surgery for complications, compared with patients of experienced surgeons, according to a report published online Sept. 9 in JAMA Surgery.

“These findings support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” wrote Dr. Blayne Welk of the department of surgery and the department of epidemiology and biostatistics at Western University and St. Joseph’s Health Care, London (Ont.) and his associates.

The investigators performed a population-based retrospective cohort study to determine the incidence of surgical removal or revision after a mesh-sling procedure for SUI and to examine whether there are specific risk factors for mesh-related complications. They analyzed data for 59,887 women who underwent the procedure across Ontario during a 10-year period. Median follow-up was 4.4 years.

The procedures were performed by 1,068 surgeons: 293 urologists, 625 gynecologists, and 150 unspecified clinicians. Cases were classified according to whether the surgeon performed a high or low volume of mesh-sling procedures specifically for SUI. High volume was defined as a number at or above the 75th percentile for yearly volume in the province, or more than 16 procedures per year.

Overall, 1,307 women (2.2%) required mesh removal or revision a median of 1 year after the initial surgery. The cumulative incidence of the composite outcome of removal/revision of vaginal or urethral mesh, removal of a foreign body, endoscopic treatment of a urethral foreign body or mesh encrustation, uretrolysis, or repair of a urethrovaginal fistula was 3.29 at 10 years, Dr. Welk and his associates reported. Surgical specialty had no significant effect on complication risk.

This incidence is consistent with previous report from HMOs in the United States and a meta-analysis of clinical trial results, the investigators noted (JAMA Surg. 2015 Sept. 9. doi: 10.1001/jamasurg.2015.2590). Patients of low-volume surgeons had a 37% higher relative risk of complications requiring reoperation than did patients of high-volume surgeons. In a further analysis of the data, patients of low-volume surgeons were significantly more likely to experience the composite outcome than were patients of high-volume surgeons (hazard ratio, 1.37), and, again, the difference between surgical specialties was nonsignificant.

Urologists and gynecologists have very different surgical training and day-to-day practices, the researchers noted, and as a result they hypothesized that complication rates might differ between the two groups of clinicians. But that was not proven in the findings.

“This suggests that procedure-specific knowledge and experience is important for surgery to treat SUI, rather than general operative training,” Dr. Welk and his associates wrote.

Women who underwent multiple mesh-based procedures for SUI were at highest risk for the composite endpoint. Their absolute risk for later mesh removal or revision was 4.87%.

“This novel finding should temper the enthusiasm of case series that suggest that the use of multiple synthetic slings is safe and efficacious,” the researchers wrote.

This finding is also important in light of the fact that 1,307 of the study participants underwent more than one mesh implant procedure, presumably for recurrent SUI.

This study was supported by the Ontario Ministry of Health and Long-term Care and the Academic Medical Organization of Southwestern Ontario. Dr. Welk reported receiving grant funding from Astellas Canada.

References

References

Publications
Publications
Topics
Article Type
Display Headline
Low-volume surgeons have most complications with mesh slings
Display Headline
Low-volume surgeons have most complications with mesh slings
Legacy Keywords
SUI, incontinence, surgical mesh sling
Legacy Keywords
SUI, incontinence, surgical mesh sling
Article Source

FROM JAMA SURGERY

PURLs Copyright

Inside the Article

Vitals

Key clinical point: The complication rate after mesh sling surgery for SUI is relatively low and highly correlated with the surgeon’s experience with the procedure.

Major finding: Patients of low-volume surgeons had a 37% higher relative risk of complications requiring reoperation than did patients of high-volume surgeons.

Data source: A population-based retrospective cohort study of 59,887 women who had SUI mesh surgery across Ontario during a 10-year period.

Disclosures: This study was supported by the Ontario Ministry of Health and Long-term Care and the Academic Medical Organization of Southwestern Ontario. Dr. Welk reported receiving grant funding from Astellas Canada.