ACS Surgery News

According to IBM, over 2 quintillion bytes of data are generated every day (that’s a 2 with 18 zeros!), with over 90% of the data in the world today generated in the past 2 years alone.

In our private lives, much of this information is generated through online shopping, web surfing, and popular websites such as Facebook and Twitter. Companies are making incredible efforts to collect these data and to use it to improve how they relate to customers and, ultimately, to make more money. For example, companies like Google, Amazon, Facebook, and Netflix collect enormous amounts of data and then use algorithms to provide real-time suggestions for what their customers might want to rent, buy, or click on. These algorithms, which companies use for anything from predicting customer behavior to facial recognition, were developed in the field of machine learning, a branch of computer science that focuses on how to learn from data.

Big data and critical care
Although the “big data” revolution has proliferated across the private sector, medicine has been slow to utilize the data we painstakingly collect in hospitals every day in order to improve patient care.

Clinicians typically rely on their intuition and the few clinical trials that their patients would have been included in to make decisions, and evidence-based clinical decision support tools are often not available or not used. The tools and scores we have at our disposal are often oversimplified so that they can be calculated by hand and usually rely on the clinician to manually gather information from the electronic health record (EHR) to calculate the score. However, this is starting to change. From partnerships between IBM Watson and hospitals, to groups developing and implementing clinical decision support tools in the EHR, it is clear that hospitals are becoming increasingly interested in learning from and using the enormous amount of data that are just sitting in the hospital records.

Although there are many areas in medicine that stand to benefit from harnessing the data available in the EHR to improve patient care, critical care should be one of the specialties that benefits the most. With the variety and frequency of monitoring that critically ill patients receive, there are large swaths of data available to collect, analyze, and harness to improve patient care. The current glut of information results in data overload and alarm fatigue for today’s clinicians, but intelligent use of these data holds promise for making care safer and more efficient and effective.

Groups have already begun using these data to develop tools to identify patients with ARDS (Herasevich V, et al. Intensive Care Med. 2009;35[6]:1018-23), patients at risk of adverse drug reactions (Harinstein LM, et al. J Crit Care. 2012;27[3]:242-9), and those with sepsis (Tafelski S, et al. J Int Med Res. 2010;38:1605-16). 

Furthermore, groups have begun “crowdsourcing” critical care problems by making large datasets publicly available, such as the Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) database, which now holds clinical data from over 40,000 ICU stays from Beth Israel Deaconess Medical Center. Continued efforts to utilize data from patients in the ICU have the potential to revolutionize the care in hospitals today. 

An important area of critical care that has seen a rapid rise in the use of EHR data to create decision support tools is in the early detection of critical illness. Given that many in-hospital cardiac arrests occur outside the ICU and delays in transferring critically ill patients to the ICU increase morbidity and mortality (Churpek MM, et al. J Hosp Med. 2016;11[11]:757-62), detecting critical illness early is incredibly important. 

For millennia, clinicians have relied on their intuition and experience to determine which patients have a poor prognosis or need increased levels of care. In the 1990s, rapid response teams (RRTs) were developed, with the goal of identifying and treating critical illness earlier. Along with them came early warning scores, which are objective tools that typically use vital sign abnormalities to detect patients at high risk of clinical deterioration. RRTs and the early warning scores used to activate them have proliferated around the world, including in the United States, and scores like the Modified Early Warning Score (MEWS) are available for automatic calculation in the EHR.

However, taking a tool such as the MEWS that can easily be calculated by hand and making our expensive EHRs calculate it is a lot like buying a Ferrari just to drive it around the parking lot. There is no reason to limit our decision support tools to simple algorithms with only a few variables, especially when patients’ lives are at stake. 

Several groups around the country have, therefore, begun to utilize other variables in the EHR, such as laboratory values, to create integrated decision support tools for the early identification of critical illness. For example, Kollef and colleagues developed a statistical model to identify critical illness and implemented it on the wards to activate their RRT, which resulted in decreased lengths of stay in the intervention group (Kollef MH, et al. J Hosp Med. 2014;9[7]:424-9).

Escobar et al. developed a model to predict ICU transfer or non-DNR deaths in the Kaiser system and found it to be more accurate than the MEWS in a validation cohort (Escobar GJ, et al. J Hosp Med. 2012;7[5]:388-95). A clinical trial of their system is ongoing. 

Finally, our group developed a model called eCART in a multicenter study of over 250,000 patients and has since implemented it in our hospital. An early “black-box” study found that eCART detected more patients who went on to experience a cardiac arrest or ICU transfer than our usual care RRT and it did so 24 hours earlier (Kang MA, et al. Crit Care Med. 2016;44[8]:1468-73). These scores and many more will likely become commonplace in hospitals to provide an objective and accurate way to identify critically ill patients earlier, which may result in decreased preventable morbidity and mortality.

Future directions
There are several important future directions at the intersection of big data and critical care.

First, efforts to collect, store, and share the highly granular data in the ICU are paramount for successful and generalizable research collaborations. Although there are often institutional barriers to data sharing to surmount, efforts such as the MIMIC database provide a roadmap for how ICU data can be shared and problems “crowdsourced” in order to allow researchers access to these data for high quality research.

Second, efforts to fuse randomized controlled trials with big data, such as randomized, embedded, multifactorial, adaptive platform (REMAP) trials, have the potential to greatly enhance the way trials are done in the future. REMAP trials would be embedded in the EHR, provide the ability to study multiple therapies at once, and adapt the randomization scheme to ensure that patients are not harmed by interventions that are clearly detrimental while the study is ongoing (Angus DC. JAMA. 2015;314[8]:767-8). 

Finally, it is important that we move beyond the classic statistical methods that are commonly used to develop decision support tools and increase our use of more modern machine learning techniques that companies in the private sector use every day. For example, our group found that classic regression methods were the least accurate of all the methods we studied for detecting clinical deterioration on the wards (Churpek MM, et al. Crit Care Med. 2016;44[2]:368-74). In the future, methods such as the random forest and neural network should become commonplace in the critical care literature.

The big data revolution is here, both in our private lives and in the hospital. The future will bring continued efforts to use data to identify critical illness earlier, improve the care of patients in the ICU, and implement smarter and more efficient clinical trials. This should rapidly increase the generation and utilization of new knowledge and will have a profound impact on the way we care for critically ill patients.

Dr. Churpek is assistant professor, section of pulmonary and critical care medicine, department of medicine at University of Chicago.

Editor’s comment
Why should busy ICU clinicians bother with big data? Isn’t this simply a “flash in the pan” phenomenon that has sprung up in the aftermath of the electronic medical records (EMRs) mandated by the Affordable Care Act? Are concerns valid that clinical data–based algorithms will lead to an endless stream of alerts akin to the ubiquitous pop-up ads for mortgage refinancing, herbal Viagra, and online gambling that has resulted from commercial data mining?
In this Critical Care Commentary, Dr. Matthew Churpek convincingly outlines the potential inherent in the big data generated by our collective ICUs. These benefits are manifesting themselves not just in the data populated within the EMR – but also in the novel ways we can now design and execute studies. And for those who aren’t yet convinced, recall that payers already use the treasure trove of information within our EMRs against us in the forms of self-serving quality metrics, punitive reimbursement, and unvalidated hospital comparison sites.

Lee E. Morrow, MD, FCCP, is the editor of the Critical Care Commentary section of CHEST Physician.

According to IBM, over 2 quintillion bytes of data are generated every day (that’s a 2 with 18 zeros!), with over 90% of the data in the world today generated in the past 2 years alone.

In our private lives, much of this information is generated through online shopping, web surfing, and popular websites such as Facebook and Twitter. Companies are making incredible efforts to collect these data and to use it to improve how they relate to customers and, ultimately, to make more money. For example, companies like Google, Amazon, Facebook, and Netflix collect enormous amounts of data and then use algorithms to provide real-time suggestions for what their customers might want to rent, buy, or click on. These algorithms, which companies use for anything from predicting customer behavior to facial recognition, were developed in the field of machine learning, a branch of computer science that focuses on how to learn from data.

Big data and critical care
Although the “big data” revolution has proliferated across the private sector, medicine has been slow to utilize the data we painstakingly collect in hospitals every day in order to improve patient care.

Clinicians typically rely on their intuition and the few clinical trials that their patients would have been included in to make decisions, and evidence-based clinical decision support tools are often not available or not used. The tools and scores we have at our disposal are often oversimplified so that they can be calculated by hand and usually rely on the clinician to manually gather information from the electronic health record (EHR) to calculate the score. However, this is starting to change. From partnerships between IBM Watson and hospitals, to groups developing and implementing clinical decision support tools in the EHR, it is clear that hospitals are becoming increasingly interested in learning from and using the enormous amount of data that are just sitting in the hospital records.

Although there are many areas in medicine that stand to benefit from harnessing the data available in the EHR to improve patient care, critical care should be one of the specialties that benefits the most. With the variety and frequency of monitoring that critically ill patients receive, there are large swaths of data available to collect, analyze, and harness to improve patient care. The current glut of information results in data overload and alarm fatigue for today’s clinicians, but intelligent use of these data holds promise for making care safer and more efficient and effective.

Groups have already begun using these data to develop tools to identify patients with ARDS (Herasevich V, et al. Intensive Care Med. 2009;35[6]:1018-23), patients at risk of adverse drug reactions (Harinstein LM, et al. J Crit Care. 2012;27[3]:242-9), and those with sepsis (Tafelski S, et al. J Int Med Res. 2010;38:1605-16). 

Furthermore, groups have begun “crowdsourcing” critical care problems by making large datasets publicly available, such as the Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) database, which now holds clinical data from over 40,000 ICU stays from Beth Israel Deaconess Medical Center. Continued efforts to utilize data from patients in the ICU have the potential to revolutionize the care in hospitals today. 

An important area of critical care that has seen a rapid rise in the use of EHR data to create decision support tools is in the early detection of critical illness. Given that many in-hospital cardiac arrests occur outside the ICU and delays in transferring critically ill patients to the ICU increase morbidity and mortality (Churpek MM, et al. J Hosp Med. 2016;11[11]:757-62), detecting critical illness early is incredibly important. 

For millennia, clinicians have relied on their intuition and experience to determine which patients have a poor prognosis or need increased levels of care. In the 1990s, rapid response teams (RRTs) were developed, with the goal of identifying and treating critical illness earlier. Along with them came early warning scores, which are objective tools that typically use vital sign abnormalities to detect patients at high risk of clinical deterioration. RRTs and the early warning scores used to activate them have proliferated around the world, including in the United States, and scores like the Modified Early Warning Score (MEWS) are available for automatic calculation in the EHR.

However, taking a tool such as the MEWS that can easily be calculated by hand and making our expensive EHRs calculate it is a lot like buying a Ferrari just to drive it around the parking lot. There is no reason to limit our decision support tools to simple algorithms with only a few variables, especially when patients’ lives are at stake. 

Several groups around the country have, therefore, begun to utilize other variables in the EHR, such as laboratory values, to create integrated decision support tools for the early identification of critical illness. For example, Kollef and colleagues developed a statistical model to identify critical illness and implemented it on the wards to activate their RRT, which resulted in decreased lengths of stay in the intervention group (Kollef MH, et al. J Hosp Med. 2014;9[7]:424-9).

Escobar et al. developed a model to predict ICU transfer or non-DNR deaths in the Kaiser system and found it to be more accurate than the MEWS in a validation cohort (Escobar GJ, et al. J Hosp Med. 2012;7[5]:388-95). A clinical trial of their system is ongoing. 

Finally, our group developed a model called eCART in a multicenter study of over 250,000 patients and has since implemented it in our hospital. An early “black-box” study found that eCART detected more patients who went on to experience a cardiac arrest or ICU transfer than our usual care RRT and it did so 24 hours earlier (Kang MA, et al. Crit Care Med. 2016;44[8]:1468-73). These scores and many more will likely become commonplace in hospitals to provide an objective and accurate way to identify critically ill patients earlier, which may result in decreased preventable morbidity and mortality.

Future directions
There are several important future directions at the intersection of big data and critical care.

First, efforts to collect, store, and share the highly granular data in the ICU are paramount for successful and generalizable research collaborations. Although there are often institutional barriers to data sharing to surmount, efforts such as the MIMIC database provide a roadmap for how ICU data can be shared and problems “crowdsourced” in order to allow researchers access to these data for high quality research.

Second, efforts to fuse randomized controlled trials with big data, such as randomized, embedded, multifactorial, adaptive platform (REMAP) trials, have the potential to greatly enhance the way trials are done in the future. REMAP trials would be embedded in the EHR, provide the ability to study multiple therapies at once, and adapt the randomization scheme to ensure that patients are not harmed by interventions that are clearly detrimental while the study is ongoing (Angus DC. JAMA. 2015;314[8]:767-8). 

Finally, it is important that we move beyond the classic statistical methods that are commonly used to develop decision support tools and increase our use of more modern machine learning techniques that companies in the private sector use every day. For example, our group found that classic regression methods were the least accurate of all the methods we studied for detecting clinical deterioration on the wards (Churpek MM, et al. Crit Care Med. 2016;44[2]:368-74). In the future, methods such as the random forest and neural network should become commonplace in the critical care literature.

The big data revolution is here, both in our private lives and in the hospital. The future will bring continued efforts to use data to identify critical illness earlier, improve the care of patients in the ICU, and implement smarter and more efficient clinical trials. This should rapidly increase the generation and utilization of new knowledge and will have a profound impact on the way we care for critically ill patients.

Dr. Churpek is assistant professor, section of pulmonary and critical care medicine, department of medicine at University of Chicago.

Editor’s comment
Why should busy ICU clinicians bother with big data? Isn’t this simply a “flash in the pan” phenomenon that has sprung up in the aftermath of the electronic medical records (EMRs) mandated by the Affordable Care Act? Are concerns valid that clinical data–based algorithms will lead to an endless stream of alerts akin to the ubiquitous pop-up ads for mortgage refinancing, herbal Viagra, and online gambling that has resulted from commercial data mining?
In this Critical Care Commentary, Dr. Matthew Churpek convincingly outlines the potential inherent in the big data generated by our collective ICUs. These benefits are manifesting themselves not just in the data populated within the EMR – but also in the novel ways we can now design and execute studies. And for those who aren’t yet convinced, recall that payers already use the treasure trove of information within our EMRs against us in the forms of self-serving quality metrics, punitive reimbursement, and unvalidated hospital comparison sites.

Lee E. Morrow, MD, FCCP, is the editor of the Critical Care Commentary section of CHEST Physician.

According to IBM, over 2 quintillion bytes of data are generated every day (that’s a 2 with 18 zeros!), with over 90% of the data in the world today generated in the past 2 years alone.

In our private lives, much of this information is generated through online shopping, web surfing, and popular websites such as Facebook and Twitter. Companies are making incredible efforts to collect these data and to use it to improve how they relate to customers and, ultimately, to make more money. For example, companies like Google, Amazon, Facebook, and Netflix collect enormous amounts of data and then use algorithms to provide real-time suggestions for what their customers might want to rent, buy, or click on. These algorithms, which companies use for anything from predicting customer behavior to facial recognition, were developed in the field of machine learning, a branch of computer science that focuses on how to learn from data.

Big data and critical care
Although the “big data” revolution has proliferated across the private sector, medicine has been slow to utilize the data we painstakingly collect in hospitals every day in order to improve patient care.

Clinicians typically rely on their intuition and the few clinical trials that their patients would have been included in to make decisions, and evidence-based clinical decision support tools are often not available or not used. The tools and scores we have at our disposal are often oversimplified so that they can be calculated by hand and usually rely on the clinician to manually gather information from the electronic health record (EHR) to calculate the score. However, this is starting to change. From partnerships between IBM Watson and hospitals, to groups developing and implementing clinical decision support tools in the EHR, it is clear that hospitals are becoming increasingly interested in learning from and using the enormous amount of data that are just sitting in the hospital records.

Although there are many areas in medicine that stand to benefit from harnessing the data available in the EHR to improve patient care, critical care should be one of the specialties that benefits the most. With the variety and frequency of monitoring that critically ill patients receive, there are large swaths of data available to collect, analyze, and harness to improve patient care. The current glut of information results in data overload and alarm fatigue for today’s clinicians, but intelligent use of these data holds promise for making care safer and more efficient and effective.

Groups have already begun using these data to develop tools to identify patients with ARDS (Herasevich V, et al. Intensive Care Med. 2009;35[6]:1018-23), patients at risk of adverse drug reactions (Harinstein LM, et al. J Crit Care. 2012;27[3]:242-9), and those with sepsis (Tafelski S, et al. J Int Med Res. 2010;38:1605-16). 

Furthermore, groups have begun “crowdsourcing” critical care problems by making large datasets publicly available, such as the Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) database, which now holds clinical data from over 40,000 ICU stays from Beth Israel Deaconess Medical Center. Continued efforts to utilize data from patients in the ICU have the potential to revolutionize the care in hospitals today. 

An important area of critical care that has seen a rapid rise in the use of EHR data to create decision support tools is in the early detection of critical illness. Given that many in-hospital cardiac arrests occur outside the ICU and delays in transferring critically ill patients to the ICU increase morbidity and mortality (Churpek MM, et al. J Hosp Med. 2016;11[11]:757-62), detecting critical illness early is incredibly important. 

For millennia, clinicians have relied on their intuition and experience to determine which patients have a poor prognosis or need increased levels of care. In the 1990s, rapid response teams (RRTs) were developed, with the goal of identifying and treating critical illness earlier. Along with them came early warning scores, which are objective tools that typically use vital sign abnormalities to detect patients at high risk of clinical deterioration. RRTs and the early warning scores used to activate them have proliferated around the world, including in the United States, and scores like the Modified Early Warning Score (MEWS) are available for automatic calculation in the EHR.

However, taking a tool such as the MEWS that can easily be calculated by hand and making our expensive EHRs calculate it is a lot like buying a Ferrari just to drive it around the parking lot. There is no reason to limit our decision support tools to simple algorithms with only a few variables, especially when patients’ lives are at stake. 

Several groups around the country have, therefore, begun to utilize other variables in the EHR, such as laboratory values, to create integrated decision support tools for the early identification of critical illness. For example, Kollef and colleagues developed a statistical model to identify critical illness and implemented it on the wards to activate their RRT, which resulted in decreased lengths of stay in the intervention group (Kollef MH, et al. J Hosp Med. 2014;9[7]:424-9).

Escobar et al. developed a model to predict ICU transfer or non-DNR deaths in the Kaiser system and found it to be more accurate than the MEWS in a validation cohort (Escobar GJ, et al. J Hosp Med. 2012;7[5]:388-95). A clinical trial of their system is ongoing. 

Finally, our group developed a model called eCART in a multicenter study of over 250,000 patients and has since implemented it in our hospital. An early “black-box” study found that eCART detected more patients who went on to experience a cardiac arrest or ICU transfer than our usual care RRT and it did so 24 hours earlier (Kang MA, et al. Crit Care Med. 2016;44[8]:1468-73). These scores and many more will likely become commonplace in hospitals to provide an objective and accurate way to identify critically ill patients earlier, which may result in decreased preventable morbidity and mortality.

Future directions
There are several important future directions at the intersection of big data and critical care.

First, efforts to collect, store, and share the highly granular data in the ICU are paramount for successful and generalizable research collaborations. Although there are often institutional barriers to data sharing to surmount, efforts such as the MIMIC database provide a roadmap for how ICU data can be shared and problems “crowdsourced” in order to allow researchers access to these data for high quality research.

Second, efforts to fuse randomized controlled trials with big data, such as randomized, embedded, multifactorial, adaptive platform (REMAP) trials, have the potential to greatly enhance the way trials are done in the future. REMAP trials would be embedded in the EHR, provide the ability to study multiple therapies at once, and adapt the randomization scheme to ensure that patients are not harmed by interventions that are clearly detrimental while the study is ongoing (Angus DC. JAMA. 2015;314[8]:767-8). 

Finally, it is important that we move beyond the classic statistical methods that are commonly used to develop decision support tools and increase our use of more modern machine learning techniques that companies in the private sector use every day. For example, our group found that classic regression methods were the least accurate of all the methods we studied for detecting clinical deterioration on the wards (Churpek MM, et al. Crit Care Med. 2016;44[2]:368-74). In the future, methods such as the random forest and neural network should become commonplace in the critical care literature.

The big data revolution is here, both in our private lives and in the hospital. The future will bring continued efforts to use data to identify critical illness earlier, improve the care of patients in the ICU, and implement smarter and more efficient clinical trials. This should rapidly increase the generation and utilization of new knowledge and will have a profound impact on the way we care for critically ill patients.

Dr. Churpek is assistant professor, section of pulmonary and critical care medicine, department of medicine at University of Chicago.

Editor’s comment
Why should busy ICU clinicians bother with big data? Isn’t this simply a “flash in the pan” phenomenon that has sprung up in the aftermath of the electronic medical records (EMRs) mandated by the Affordable Care Act? Are concerns valid that clinical data–based algorithms will lead to an endless stream of alerts akin to the ubiquitous pop-up ads for mortgage refinancing, herbal Viagra, and online gambling that has resulted from commercial data mining?
In this Critical Care Commentary, Dr. Matthew Churpek convincingly outlines the potential inherent in the big data generated by our collective ICUs. These benefits are manifesting themselves not just in the data populated within the EMR – but also in the novel ways we can now design and execute studies. And for those who aren’t yet convinced, recall that payers already use the treasure trove of information within our EMRs against us in the forms of self-serving quality metrics, punitive reimbursement, and unvalidated hospital comparison sites.

Lee E. Morrow, MD, FCCP, is the editor of the Critical Care Commentary section of CHEST Physician.

SAN DIEGO – An artificial red blood cell has come close to emulating the key functions of natural cells and does not appear to be associated with the side effects such as vasospasm and poor response to changes in blood pH that hampered the development of previous artificial blood products, Allan Doctor, MD, reported at the annual meeting of the American Society of Hematology.

The bio-synthetic cells, called ErythroMer, are about 1/50th the size of natural red blood cells. They can be stored at room temperature and reconstituted with water when needed for use.

In a mouse model, the ErythroMer cells were shown to capture oxygen in the lungs and release it to tissue in a pattern that was nearly identical to blood transfusion. In a rat model of shock, ErythroMer was effective for resuscitation.

In a video interview, Dr. Doctor of Washington University in St. Louis discussed the pharmacokinetics of ErythroMer, the need for a readily available blood substitute for treating trauma patients, other potential uses for artificial blood cells, and next steps for testing the product.

Dr. Doctor has equity ownership in KaloCyte, the company developing ErythroMer. He receives research funding from Children’s Discovery Institute and the National Institutes of Health.

[email protected]

SAN DIEGO – An artificial red blood cell has come close to emulating the key functions of natural cells and does not appear to be associated with the side effects such as vasospasm and poor response to changes in blood pH that hampered the development of previous artificial blood products, Allan Doctor, MD, reported at the annual meeting of the American Society of Hematology.

The bio-synthetic cells, called ErythroMer, are about 1/50th the size of natural red blood cells. They can be stored at room temperature and reconstituted with water when needed for use.

In a mouse model, the ErythroMer cells were shown to capture oxygen in the lungs and release it to tissue in a pattern that was nearly identical to blood transfusion. In a rat model of shock, ErythroMer was effective for resuscitation.

In a video interview, Dr. Doctor of Washington University in St. Louis discussed the pharmacokinetics of ErythroMer, the need for a readily available blood substitute for treating trauma patients, other potential uses for artificial blood cells, and next steps for testing the product.

Dr. Doctor has equity ownership in KaloCyte, the company developing ErythroMer. He receives research funding from Children’s Discovery Institute and the National Institutes of Health.

[email protected]

SAN DIEGO – An artificial red blood cell has come close to emulating the key functions of natural cells and does not appear to be associated with the side effects such as vasospasm and poor response to changes in blood pH that hampered the development of previous artificial blood products, Allan Doctor, MD, reported at the annual meeting of the American Society of Hematology.

The bio-synthetic cells, called ErythroMer, are about 1/50th the size of natural red blood cells. They can be stored at room temperature and reconstituted with water when needed for use.

In a mouse model, the ErythroMer cells were shown to capture oxygen in the lungs and release it to tissue in a pattern that was nearly identical to blood transfusion. In a rat model of shock, ErythroMer was effective for resuscitation.

In a video interview, Dr. Doctor of Washington University in St. Louis discussed the pharmacokinetics of ErythroMer, the need for a readily available blood substitute for treating trauma patients, other potential uses for artificial blood cells, and next steps for testing the product.

Dr. Doctor has equity ownership in KaloCyte, the company developing ErythroMer. He receives research funding from Children’s Discovery Institute and the National Institutes of Health.

[email protected]

WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”

This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”

This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – First-generation, balloon-expandable transcatheter aortic valves had a less than 1% rate of valve failure in planned echocardiography examinations during follow-up that extended as long as 5 years after valve placement in more than 2,400 patients, a demonstration of durability that experts uniformly called “reassuring.”

This finding from patients who underwent transcatheter aortic valve replacement (TAVR) in the first U.S. pivotal trial for these devices, PARTNER 1 parts A and B, and during the subsequent continued-access program at PARTNER 1 study sites, represents the largest and longest systematic ultrasound follow-up of TAVR patients, Pamela S. Douglas, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

PARTNER 1 was sponsored by Edwards Lifesciences, the company that had marketed the Sapien first-generation, balloon expandable TAVR system. Dr. Douglas has received research support from Edwards. Dr. Bonow had no disclosures. Dr. Popma has been the lead investigator for several studies of a self-expanding TAVR system sponsored by Medtronic, and he has also received research funding from several other companies, has been a consultant to Boston Scientific and Direct Flow, and owns equity in Direct Flow. Dr. Dvir has been a consultant to and received research support from Edwards, Medtronic, and St. Jude. Dr. Reardon has been a consultant to Medtronic.

[email protected]

On Twitter @mitchelzoler

A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

“The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

[email protected]

A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

“The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

[email protected]

A pared-down version of the 21st Century Cures Act passed the House Nov. 30 by an overwhelming 392-26 vote, setting the stage for a quick Senate vote on the compromise legislation.

H.R. 34 gained more support on the House floor than did a version of the legislation that passed the House in 2015. In order to gain that additional support and ensure Senate approval, funding for key biomedical research efforts – the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative – was reduced from $9.3 billion to $4.8 billion over 10 years. Further, those funds are not guaranteed but will need to be appropriated through the federal budget process.

Alicia Ault/Frontline Medical News

Other provisions include creation of an NIH program to support new researchers; funds to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases; the development of a national neurologic condition surveillance system; and the establishment of a task force on research specific to pregnant and breastfeeding women.

“More women with chronic diseases are becoming pregnant, yet safe and effective medications to manage these ongoing conditions throughout their pregnancy and beyond are needed,” Mary Norton, MD, president of the Society for Maternal-Fetal Medicine, said in a statement. “This legislation is a great first step toward greater collaboration and communication among federal agencies and public stakeholders.”

The 21st Century Cures bill also “takes concrete steps to help women and families suffering from postpartum depression,” Thomas Gellhaus, MD, president of the American College of Obstetricians and Gynecologists, said in a statement. “Postpartum depression is one of the most common medical complications following pregnancy. ... Cures expands state programs to better identify, treat, and support women and families at risk for or facing postpartum depression.”

The bill provides $500 million to the Food and Drug Administration to help the agency speed up the drug approval process, focusing on identifying biomarkers and developing targeted drugs for rare diseases. It also reauthorizes the pediatric rare disease priority review voucher program; requires drug companies to have a publicly accessible compassionate use policy for drugs treating serious or life-threatening conditions; and provides flexibility to get new antimicrobial drugs to market quickly.

Changes in the drug approval process were contentious during debate on the House floor.

“In its attempt to speed up the drug and device approval process, this legislation neglects the very people whom clinical trials are meant to help, that is, the patients,” Rep. Rosa DeLauro (D-Conn.) said. “Rather than protect those who rely on the health care system, it reduces the already weak regulation on medical devices, allows drugs with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics.”

Other legislators expressed disappointment at the bill’s mental health care provisions. Rep. Joseph Kennedy III (D-Mass.) said that his “real concerns with the legislation lie with the mental health reform proposals, which don’t go nearly far enough. Mental health parity is already the law, thanks to the Mental Health Parity and Addiction Equity Act and the Affordable Care Act; but each study we read, Mr. Speaker, and each story we hear proves that insurance companies are skirting those rules.

“We need enforcement and transparency today,” Rep. Kennedy continued. “We need random audits before there have been violations, not after. We need insurers to publicly disclose the rates and reasons for denials in a way that patients and their families can understand, not in away that mental health advocates can’t even obtain. We need to increase Medicaid reimbursements in order to expand access to care, not to reduce them or roll back expansion.”

The pediatric provisions drew mixed reviews from the American Academy of Pediatrics.

“The 21st Century Cures Act includes three new programs that, if funded, would improve infant and child mental health: one that supports behavioral and mental health integration into the pediatric primary care setting, one that increases screening and treatment for maternal depression, and one that enhances infant and early childhood mental health,” AAP President Benard Dreyer, MD, said in a statement. “Of additional note is a provision that incentivizes the certification of health information technology for use by pediatricians, and a provision that ensures children in [psychiatric facilities] receive Medicaid’s early periodic screening, treatment, and diagnosis gold standard of care. Finally, the AAP supports the 21st Century Cures Act’s reauthorization of a bill to prevent underage drinking, which includes a new program to train pediatric health professionals in substance use screening, intervention, and referrals.”

However, Dr. Dreyer noted that more work needs to be done.

“The Family First Prevention Services Act of 2016, a comprehensive, bipartisan effort to improve how the child welfare system serves children and families in adversity, was connected to the 21st Century Cures Act until earlier this week,” he said. “Family First represents more than 2 years of work, and is a pivotal opportunity for a major federal policy shift away from placing children in out-of-home care and toward keeping families together. Removing it from this legislative package could mean losing the chance to pass it at all, an unacceptable and undeserved setback for the nation’s most vulnerable children.”

21st Century Cures also contains health IT-related provisions, mostly aimed at improving the interoperability of electronic health records. It also reduces the documentation burden on providers and establishes the authority for the HHS Office of Inspector General to penalize those engaged in information blocking between EHRs.

The bill also increases the transparency around Medicare local coverage decisions and exempts certain transfers of value from reporting requirements related to continuing education. It sets reimbursement for Medicare Part B drugs infused through durable medical equipment at 106% of average sales price.

Sen. Lamar Alexander, chairman of the Health, Education, Labor and Pensions Committee, said that a vote in that chamber could happen as early as Dec. 5. Upon House passage, President Obama signaled his intention to sign the bill, according to a statement from the White House Press Secretary.

[email protected]

WASHINGTON – Acting Administrator Andy Slavitt has some advice for his successors at the CMS: Keep the Center for Medicare & Medicaid Innovation, even if you trash the Affordable Care Act.

The innovation center is vital to the success of the Quality Payment Program, the value-based payment framework set up by the Medicare Access and CHIP Reauthorization Act (MACRA), Mr. Slavitt said Dec. 1 at the National MACRA MIPS/APM Summit.

Gregory Twachtman/Frontline Medical News

Mr. Slavitt offered a few other recommendations to the next regime. First, he called on the Trump administration to ensure that the 20 million people who have obtained health care coverage under the ACA do not lose it as a key to continued delivery system reform.

“Build from a foundation of progress, do not head backwards,” Mr. Slavitt advised. “There can be no delivery system reform without building on the foundation of reaching universal coverage.”

To that end, he advised keeping other key ACA provisions, including no-cost preventive care, the elimination of annual and lifetime coverage caps, and the end of pre-existing condition exclusions.

“If we want to fix how care is delivered, so that we’re providing value, then we must ensure that Americans can afford and access quality care at every point in their lives,” he said. “If we lose even some of the coverage gains made under the ACA, or leave people in limbo, people will lose access to regular care and we will drive up long-term costs.”

He also called for more improvements in the health IT space, including a demand for affordable systems and technologies that can exchange data and support quality health care.

“MACRA is an opportunity to move the focus away from paperwork and reporting and toward paying for what works,” Mr. Slavitt said. “For a variety of reasons, EHRs became an industry before they became a useful tool. The technology community must be held accountable ... to make room for new innovators and to give clinicians more freedom and more flexibility to focus on their patients, to practice medicine, and deliver better care.”

President-elect Trump has designated Seema Verma, a health care consultant who helped design the Indiana’s ACA Medicaid expansion, to be the next CMS administrator.

[email protected]

WASHINGTON – Acting Administrator Andy Slavitt has some advice for his successors at the CMS: Keep the Center for Medicare & Medicaid Innovation, even if you trash the Affordable Care Act.

The innovation center is vital to the success of the Quality Payment Program, the value-based payment framework set up by the Medicare Access and CHIP Reauthorization Act (MACRA), Mr. Slavitt said Dec. 1 at the National MACRA MIPS/APM Summit.

Gregory Twachtman/Frontline Medical News

Mr. Slavitt offered a few other recommendations to the next regime. First, he called on the Trump administration to ensure that the 20 million people who have obtained health care coverage under the ACA do not lose it as a key to continued delivery system reform.

“Build from a foundation of progress, do not head backwards,” Mr. Slavitt advised. “There can be no delivery system reform without building on the foundation of reaching universal coverage.”

To that end, he advised keeping other key ACA provisions, including no-cost preventive care, the elimination of annual and lifetime coverage caps, and the end of pre-existing condition exclusions.

“If we want to fix how care is delivered, so that we’re providing value, then we must ensure that Americans can afford and access quality care at every point in their lives,” he said. “If we lose even some of the coverage gains made under the ACA, or leave people in limbo, people will lose access to regular care and we will drive up long-term costs.”

He also called for more improvements in the health IT space, including a demand for affordable systems and technologies that can exchange data and support quality health care.

“MACRA is an opportunity to move the focus away from paperwork and reporting and toward paying for what works,” Mr. Slavitt said. “For a variety of reasons, EHRs became an industry before they became a useful tool. The technology community must be held accountable ... to make room for new innovators and to give clinicians more freedom and more flexibility to focus on their patients, to practice medicine, and deliver better care.”

President-elect Trump has designated Seema Verma, a health care consultant who helped design the Indiana’s ACA Medicaid expansion, to be the next CMS administrator.

[email protected]

WASHINGTON – Acting Administrator Andy Slavitt has some advice for his successors at the CMS: Keep the Center for Medicare & Medicaid Innovation, even if you trash the Affordable Care Act.

The innovation center is vital to the success of the Quality Payment Program, the value-based payment framework set up by the Medicare Access and CHIP Reauthorization Act (MACRA), Mr. Slavitt said Dec. 1 at the National MACRA MIPS/APM Summit.

Gregory Twachtman/Frontline Medical News

Mr. Slavitt offered a few other recommendations to the next regime. First, he called on the Trump administration to ensure that the 20 million people who have obtained health care coverage under the ACA do not lose it as a key to continued delivery system reform.

“Build from a foundation of progress, do not head backwards,” Mr. Slavitt advised. “There can be no delivery system reform without building on the foundation of reaching universal coverage.”

To that end, he advised keeping other key ACA provisions, including no-cost preventive care, the elimination of annual and lifetime coverage caps, and the end of pre-existing condition exclusions.

“If we want to fix how care is delivered, so that we’re providing value, then we must ensure that Americans can afford and access quality care at every point in their lives,” he said. “If we lose even some of the coverage gains made under the ACA, or leave people in limbo, people will lose access to regular care and we will drive up long-term costs.”

He also called for more improvements in the health IT space, including a demand for affordable systems and technologies that can exchange data and support quality health care.

“MACRA is an opportunity to move the focus away from paperwork and reporting and toward paying for what works,” Mr. Slavitt said. “For a variety of reasons, EHRs became an industry before they became a useful tool. The technology community must be held accountable ... to make room for new innovators and to give clinicians more freedom and more flexibility to focus on their patients, to practice medicine, and deliver better care.”

President-elect Trump has designated Seema Verma, a health care consultant who helped design the Indiana’s ACA Medicaid expansion, to be the next CMS administrator.

[email protected]

ORLANDO – Ultrasound appears to be an effective tool in diagnosing occult hernia in women with unexplained chronic pelvic pain, according to a retrospective cohort study of 96 women.

“As gynecologists, we are likely to see those patients with chronic pelvic pain in our clinic before other specialists due to the location of their pain,” said Joelle Aoun, MD, an ob.gyn. in the division of minimally invasive gynecologic surgery at Henry Ford Health System in Detroit. “So it’s very important to recognize women with a high clinical suspicion for occult hernia and evaluate them in order to prevent a delayed diagnosis and prolonged suffering.”

Hernias can be more difficult to diagnose in women than in men, Dr. Aoun said at the meeting sponsored by AAGL, and the literature offers conflicting findings since most hernia studies are conducted in men or with mixed gender cohorts.

Dr. Aoun and her coinvestigators conducted a retrospective cohort study from January 2005 to July 2016, identifying 96 women with chronic pelvic pain and focal inguinal tenderness. Protruding fat or visceral tissue on physical exam or observed visually led clinicians to suspect a hernia. A single sonographer performed the musculoskeletal ultrasound.

Investigators diagnosed an occult hernia in more than half of the patients (51 women) based on the physical exam and ultrasound findings. Diagnoses included inguinal, femoral, Spigelian, and umbilical hernias.

All women with an ultrasound-diagnosed hernia were referred to general surgery. A majority – 69% of women – underwent surgical exploration. The remaining 31% of women who declined tended to have lower pain scores, Dr. Aoun said. Surgeons confirmed the hernia diagnosis in 97% of the women, or 34 out of the 35 women who had consented to surgery.

The group with a hernia was older and more likely to have arthritis, but otherwise did not differ significantly from the nonhernia cohort.

“We believe musculoskeletal ultrasound is valuable as an initial imaging modality due to its high predictive value, low cost, and noninvasiveness,” Dr. Aoun said.

Chronic pelvic pain is not uncommon, affecting approximately 15% of women during their reproductive years often with significant impacts on quality of life, workplace productivity, and health care utilization, Dr. Aoun said. This presentation also accounts for about 10% outpatient gynecology consultations and approximately 40% of laparoscopies in the United States, she added.

Dr. Aoun and her colleagues are planning a subsequent study of all the women who opted not to undergo surgery to determine their follow-up pain profiles based on chart review and phone interviews.

Dr. Aoun reported having no relevant financial disclosures.

ORLANDO – Ultrasound appears to be an effective tool in diagnosing occult hernia in women with unexplained chronic pelvic pain, according to a retrospective cohort study of 96 women.

“As gynecologists, we are likely to see those patients with chronic pelvic pain in our clinic before other specialists due to the location of their pain,” said Joelle Aoun, MD, an ob.gyn. in the division of minimally invasive gynecologic surgery at Henry Ford Health System in Detroit. “So it’s very important to recognize women with a high clinical suspicion for occult hernia and evaluate them in order to prevent a delayed diagnosis and prolonged suffering.”

Hernias can be more difficult to diagnose in women than in men, Dr. Aoun said at the meeting sponsored by AAGL, and the literature offers conflicting findings since most hernia studies are conducted in men or with mixed gender cohorts.

Dr. Aoun and her coinvestigators conducted a retrospective cohort study from January 2005 to July 2016, identifying 96 women with chronic pelvic pain and focal inguinal tenderness. Protruding fat or visceral tissue on physical exam or observed visually led clinicians to suspect a hernia. A single sonographer performed the musculoskeletal ultrasound.

Investigators diagnosed an occult hernia in more than half of the patients (51 women) based on the physical exam and ultrasound findings. Diagnoses included inguinal, femoral, Spigelian, and umbilical hernias.

All women with an ultrasound-diagnosed hernia were referred to general surgery. A majority – 69% of women – underwent surgical exploration. The remaining 31% of women who declined tended to have lower pain scores, Dr. Aoun said. Surgeons confirmed the hernia diagnosis in 97% of the women, or 34 out of the 35 women who had consented to surgery.

The group with a hernia was older and more likely to have arthritis, but otherwise did not differ significantly from the nonhernia cohort.

“We believe musculoskeletal ultrasound is valuable as an initial imaging modality due to its high predictive value, low cost, and noninvasiveness,” Dr. Aoun said.

Chronic pelvic pain is not uncommon, affecting approximately 15% of women during their reproductive years often with significant impacts on quality of life, workplace productivity, and health care utilization, Dr. Aoun said. This presentation also accounts for about 10% outpatient gynecology consultations and approximately 40% of laparoscopies in the United States, she added.

Dr. Aoun and her colleagues are planning a subsequent study of all the women who opted not to undergo surgery to determine their follow-up pain profiles based on chart review and phone interviews.

Dr. Aoun reported having no relevant financial disclosures.

ORLANDO – Ultrasound appears to be an effective tool in diagnosing occult hernia in women with unexplained chronic pelvic pain, according to a retrospective cohort study of 96 women.

“As gynecologists, we are likely to see those patients with chronic pelvic pain in our clinic before other specialists due to the location of their pain,” said Joelle Aoun, MD, an ob.gyn. in the division of minimally invasive gynecologic surgery at Henry Ford Health System in Detroit. “So it’s very important to recognize women with a high clinical suspicion for occult hernia and evaluate them in order to prevent a delayed diagnosis and prolonged suffering.”

Hernias can be more difficult to diagnose in women than in men, Dr. Aoun said at the meeting sponsored by AAGL, and the literature offers conflicting findings since most hernia studies are conducted in men or with mixed gender cohorts.

Dr. Aoun and her coinvestigators conducted a retrospective cohort study from January 2005 to July 2016, identifying 96 women with chronic pelvic pain and focal inguinal tenderness. Protruding fat or visceral tissue on physical exam or observed visually led clinicians to suspect a hernia. A single sonographer performed the musculoskeletal ultrasound.

Investigators diagnosed an occult hernia in more than half of the patients (51 women) based on the physical exam and ultrasound findings. Diagnoses included inguinal, femoral, Spigelian, and umbilical hernias.

All women with an ultrasound-diagnosed hernia were referred to general surgery. A majority – 69% of women – underwent surgical exploration. The remaining 31% of women who declined tended to have lower pain scores, Dr. Aoun said. Surgeons confirmed the hernia diagnosis in 97% of the women, or 34 out of the 35 women who had consented to surgery.

The group with a hernia was older and more likely to have arthritis, but otherwise did not differ significantly from the nonhernia cohort.

“We believe musculoskeletal ultrasound is valuable as an initial imaging modality due to its high predictive value, low cost, and noninvasiveness,” Dr. Aoun said.

Chronic pelvic pain is not uncommon, affecting approximately 15% of women during their reproductive years often with significant impacts on quality of life, workplace productivity, and health care utilization, Dr. Aoun said. This presentation also accounts for about 10% outpatient gynecology consultations and approximately 40% of laparoscopies in the United States, she added.

Dr. Aoun and her colleagues are planning a subsequent study of all the women who opted not to undergo surgery to determine their follow-up pain profiles based on chart review and phone interviews.

Dr. Aoun reported having no relevant financial disclosures.

Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.

Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.

These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.

All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.

Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.

This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.

Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.

All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.

Dr. Udelsman and his coauthors reported having no financial disclosures.
 

Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.

Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.

These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.

All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.

Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.

This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.

Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.

All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.

Dr. Udelsman and his coauthors reported having no financial disclosures.
 

Large and complex airway defects that primary repair cannot fully close require alternative surgical approaches and techniques that are far more difficult to perform, but bioprosthetic materials may be an option to repair large tracheal and bronchial defects that has achieved good results, without postoperative death or defect recurrence, in a small cohort of patients at Massachusetts General Hospital, in Boston.

Brooks Udelsman, MD, and his coauthors reported their results of bioprosthetic repair of central airway defects in eight patients in the Journal of Thoracic and Cardiovascular Surgery (2016 Nov;152:1388-97). “Although our results are derived from a limited number of heterogeneous patients, they suggest that closure of noncircumferential large airway defects with bioprosthetic materials is feasible, safe and reliable,” Dr. Udelsman said. He previously reported the results at the annual meeting of the American Association for Thoracic Surgery, May 14-18, 2016, in Baltimore.

These complex defects typically exceed 5 cm and can involve communication with the esophagus. For repair of smaller defects, surgeons can use a more conventional approach that involves neck flexion, laryngeal release, airway mobilization, and hilar release, but in larger defects, these techniques increase the risk of too much tension on the anastomosis and dehiscence along with airway failure. Large and complex defects occur in patients who have had a previous airway operation or radiation exposure, requiring alternative strategies, the researchers wrote. “Patients in this rare category should be referred to a high-volume center for careful evaluation by a surgeon experienced in complex airway reconstruction before the decision to abandon primary repair is made,” he said. Among the advantages that bioprosthetic materials have over synthetic materials for airway defect repair are easier handling, minimal immunogenic response, and potential for tissue ingrowth, Dr. Udelsman and his coauthors said.

All eight patients in this study, who underwent repair from 2008 to 2015, had significant comorbidities, including previous surgery of the trachea, esophagus, or thyroid. The etiology of the airway defect included HIV-AIDS–associated esophagitis, malignancy, mesh erosion, and complications from extended intubation. Three patients had previous radiation therapy to the neck or chest. Five patients had defects localized to the membranous tracheal wall, two had defects of the mainstem bronchus or bronchus intermedius, and one patient had a defect of the anterior wall of the trachea.

Dr. Udelsman and his coauthors used both aortic homograft and acellular dermal matrix to repair large defects. Their experience confirmed previous reports of the formation of granulation tissue with aortic autografts, underscoring the importance of frequent bronchoscopy and debridement when necessary. And while previous reports have claimed human acellular dermis resists granulation formation, that wasn’t the case in this study. “The exact histologic basis of bioprosthetic incorporation and reepithelialization in these patients is still elusive and will require further study,” the researchers said.

This study also employed the controversial muscle buttress repair in six patients, which helped, at least theoretically, to secure the repairs when leaks occur, to separate suture lines when both the airway and esophagus were repaired and to support the bioprosthetic material to prevent tissue softening, Dr. Udelsman and his coauthors said.

Postoperative examinations confirmed that the operations successfully closed the airway defects in all eight patients. Long term, most resumed oral intake, but three did not for various reasons: one had a pharyngostomy; another had neurocognitive issues preoperatively; and a third with a tracheoesophageal fistula repair and cervical esophagostomy could resume oral intake but depended on tube feeds to meet caloric needs.

All patients developed granulation at the repair site, two of whom required further debridement and one who underwent balloon dilation. Pneumonia was the most common complication within 30 days of surgery, occurring in two patients. Three patients died within 120 days from metastatic disease, and a fourth patient progressed to end-stage AIDS 6 years after the operation and eventually died.

Dr. Udelsman and his coauthors reported having no financial disclosures.
 

ORLANDO – Following the Food and Drug Administration’s 2014 warning against use of laparoscopic uterine power morcellation, 13% of gynecologic oncologists decreased their use of the technique and another 39% discontinued it altogether, according to survey responses from 199 members of the Society of Gynecologic Oncology.

“This really gives a snapshot about how gynecologic oncologists feel about power morcellation in light of the FDA warning,” said Kerac N. Falk, MD, a resident at the Icahn School of Medicine at Mount Sinai, New York.

About 41% of gynecologic oncologists changed their surgical technique to minimally invasive without power morcellation. Another 20% of respondents who previously used power morcellation have switched to laparotomy.

A more rigorous informed consent process, better attention to patient selection, and enhanced protocols are positive effects emerging since the FDA Safety Communication was issued in April 2014, Dr. Falk said at the meeting sponsored by AAGL.

The 34-item survey included questions about demographics, institutional policies, and attitudes before and after the FDA warning. Among the respondents, 65% were men. Both “early” and “very seasoned” surgeons participated in the survey. The majority of the respondents were moderate- to high-volume surgeons.

Men were significantly more likely to decrease or discontinue use of power morcellation, compared with women (P = .0015). Region of practice, years in practice, or institution type did not significantly influence changes in practice. “Most said it was not a personal choice, but more about patient choice or an institutional policy change,” Dr. Falk said.

There is still a role for power morcellation in carefully selected patients, Dr. Falk added.

In July 2014, AAGL issued a statement in response to the FDA warning, stating that “we should improve but not abandon power morcellation, and that power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.” In addition, the American College of Obstetricians and Gynecologists stated, “Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it.”

Dr. Falk is not a coauthor on the study. He presented the findings on behalf of a colleague unable to attend the meeting. Dr. Falk reported having no relevant financial disclosures.

ORLANDO – Following the Food and Drug Administration’s 2014 warning against use of laparoscopic uterine power morcellation, 13% of gynecologic oncologists decreased their use of the technique and another 39% discontinued it altogether, according to survey responses from 199 members of the Society of Gynecologic Oncology.

“This really gives a snapshot about how gynecologic oncologists feel about power morcellation in light of the FDA warning,” said Kerac N. Falk, MD, a resident at the Icahn School of Medicine at Mount Sinai, New York.

About 41% of gynecologic oncologists changed their surgical technique to minimally invasive without power morcellation. Another 20% of respondents who previously used power morcellation have switched to laparotomy.

A more rigorous informed consent process, better attention to patient selection, and enhanced protocols are positive effects emerging since the FDA Safety Communication was issued in April 2014, Dr. Falk said at the meeting sponsored by AAGL.

The 34-item survey included questions about demographics, institutional policies, and attitudes before and after the FDA warning. Among the respondents, 65% were men. Both “early” and “very seasoned” surgeons participated in the survey. The majority of the respondents were moderate- to high-volume surgeons.

Men were significantly more likely to decrease or discontinue use of power morcellation, compared with women (P = .0015). Region of practice, years in practice, or institution type did not significantly influence changes in practice. “Most said it was not a personal choice, but more about patient choice or an institutional policy change,” Dr. Falk said.

There is still a role for power morcellation in carefully selected patients, Dr. Falk added.

In July 2014, AAGL issued a statement in response to the FDA warning, stating that “we should improve but not abandon power morcellation, and that power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.” In addition, the American College of Obstetricians and Gynecologists stated, “Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it.”

Dr. Falk is not a coauthor on the study. He presented the findings on behalf of a colleague unable to attend the meeting. Dr. Falk reported having no relevant financial disclosures.

ORLANDO – Following the Food and Drug Administration’s 2014 warning against use of laparoscopic uterine power morcellation, 13% of gynecologic oncologists decreased their use of the technique and another 39% discontinued it altogether, according to survey responses from 199 members of the Society of Gynecologic Oncology.

“This really gives a snapshot about how gynecologic oncologists feel about power morcellation in light of the FDA warning,” said Kerac N. Falk, MD, a resident at the Icahn School of Medicine at Mount Sinai, New York.

About 41% of gynecologic oncologists changed their surgical technique to minimally invasive without power morcellation. Another 20% of respondents who previously used power morcellation have switched to laparotomy.

A more rigorous informed consent process, better attention to patient selection, and enhanced protocols are positive effects emerging since the FDA Safety Communication was issued in April 2014, Dr. Falk said at the meeting sponsored by AAGL.

The 34-item survey included questions about demographics, institutional policies, and attitudes before and after the FDA warning. Among the respondents, 65% were men. Both “early” and “very seasoned” surgeons participated in the survey. The majority of the respondents were moderate- to high-volume surgeons.

Men were significantly more likely to decrease or discontinue use of power morcellation, compared with women (P = .0015). Region of practice, years in practice, or institution type did not significantly influence changes in practice. “Most said it was not a personal choice, but more about patient choice or an institutional policy change,” Dr. Falk said.

There is still a role for power morcellation in carefully selected patients, Dr. Falk added.

In July 2014, AAGL issued a statement in response to the FDA warning, stating that “we should improve but not abandon power morcellation, and that power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.” In addition, the American College of Obstetricians and Gynecologists stated, “Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it.”

Dr. Falk is not a coauthor on the study. He presented the findings on behalf of a colleague unable to attend the meeting. Dr. Falk reported having no relevant financial disclosures.

People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.

“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.

The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).

Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.

The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.

After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.

Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.

“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”

About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.

Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.

People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.

“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.

The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).

Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.

The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.

After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.

Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.

“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”

About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.

Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.

People who have undergone the Fontan procedure have been known to be prone to developing arrhythmias, but few studies have evaluated their prognosis, so researchers from Australia and New Zealand analyzed results of more than 1,000 patients with Fontan circulation and found that two-thirds did not have any arrhythmia at 20 years, and that, among those who did have arrhythmias, almost three-quarters survived 10 years.

“After the first onset of an arrhythmia, close surveillance of ventricular function is required,” Thomas A. Carins, MD, and his colleagues reported (J Thorac Cardiovasc Surg. 2016;152:1355-63). They analyzed data from 1,034 patients who had Fontan procedures from 1975 to 2014 in the Australia and New Zealand Fontan Registry. “The development of an arrhythmia is associated with a heightened risk of subsequent failure of the Fontan circulation,” they wrote.

The study aimed to determine the type of arrhythmias Fontan patients had and what impact that had on long-term outcomes. The most common Fontan approach used in study patients was the extracardiac conduit (555), followed by the lateral tunnel approach (269) and atriopulmonary (210). Those who had the extracardiac Fontan were least likely to develop an arrhythmia, with a hazard ratio of 0.23 (P less than .001), which Dr. Carins and his coauthors noted was in line with previous reports of arrhythmias occurring in patients who had undergone the atriopulmonary connection (Circulation. 2004;109:2319-25; J Thorac Cardiovasc Surg. 1998;115:499-505).

Overall, 195 patients in the study developed arrhythmia, with 162 having tachyarrhythmia, 74 having bradyarrhythmia and 41 having both. “At 20 years, freedom from any arrhythmia, tachyarrhythmia, and bradyarrhythmia was 66%, 69%, and 85%, respectively,” the researchers said.

The following outcomes occurred after the first onset of arrhythmia – tachyarrhythmia in 153 patients and bradyarrhythmia in 42: Thirty-three died; 12 had heart transplants, 30 had a Fontan correction to an extracardiac conduit, three had a Fontan takedown, 12 developed enteropathy, and 25 developed New York Heart Association class III or IV symptoms. Eighty-four patients reached the composite endpoint of Fontan failure.

After they developed arrhythmias, most patients in all three Fontan procedure groups remained free from Fontan failure at 10 years: 67% in the extracardiac conduit group; 54% in the lateral tunnel group; and 51% in the atriopulmonary group.

Medical management of up to four medications was the preferred initial treatment for those with tachyarrhythmias (86%); 101 patients had a single episode of tachyarrhythmia at follow-up intervals of four to 13 years (7.6 year median). “Those who experienced a single versus multiple episodes of tachyarrhythmia showed comparable freedom from Fontan failure at 15 years,” noted Dr. Carins and his coauthors – with rates of 34% and 33%, respectively. Of the 74 patients with bradyarrhythmias, 66 received pacemakers.

“Survival after the onset of an arrhythmia was surprisingly good with 67% and 84% of patients alive at 10 years after the onset of a tachyarrhythmia and bradyarrhythmia, respectively,” the study authors said. “There was no association between occurrence of arrhythmia and survival.”

About 40% of the patients with a tachyarrhythmia or bradyarrhythmia in the study had reduced ventricular function at 10 years after onset, the researchers wrote. “Although the assessment of ventricular function in this study was clearly subjective, we nonetheless believe that these findings suggest that the onset of an arrhythmia is associated with a progressive deterioration in cardiac function,”they noted.

Coauthor Andrew Bullock, MBBS, disclosed receiving consulting fees from Actelion. Dr. Cairns and other coauthors had no financial relationships to disclose.

Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).

Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.

Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.

CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.

Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.

Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.

CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.

Dr. Voron and coauthors had no financial relationships to disclose.

[email protected]

Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).

Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.

Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.

CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.

Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.

Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.

CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.

Dr. Voron and coauthors had no financial relationships to disclose.

[email protected]

Ingestion of caustic substances like alkali, acid, and bleaches that call for esophageal surgery is relatively rare, and the study of dealing with postsurgery complications even rarer, but a team of surgeons from a large public referral hospital in Paris has collected enough cases over the first years of this century to report that a form of revision surgery in these cases can yield good outcomes with acceptable morbidity, according to a study in the Journal of Thoracic and Cardiovascular Surgery (2016;152:1378-85).

Thibault Voron, MD, and coauthors at Hôpitaux Saint-Louis and the University of Paris performed revision cervicosternolaparotomy (CSLap) on 55 patients from 1999 to 2015. Two patients (4%) died and the severe morbidity rate was 27%, but the long-term functional success rate was 85%. “Of note, these figures compare favorably with results of primary esophageal reconstruction for caustic injuries in the literature,” Dr. Voron and colleagues said. Overall the study authors performed revision surgery on 100 patients, with the remaining 45 undergoing repair through a limited approach. There were no significant differences in characteristics between the two groups.

Primary esophageal reconstruction for caustic injuries can usually be done at referral centers with good results, but up to half of these patients can have late complications, consisting mostly of strictures and redundancy that can cause loss of function, Dr. Voron and coauthors said. Published series have reported revision surgery in 15%-38% of patients (Dis Esophagus. 2008;21:E1-5; Dis Esophagus. 1999;12:7-9), but revision surgery itself is difficult to accomplish.

CSLap involves a large operative field from the jaw to the pubis. It starts with a comprehensive neck exploration through the previous cervical incision or with a median laparotomy to rule out a limited-approach repair. CSLap was undertaken when the graft was too short for a tension-free anastomosis. After the upper part of the graft was dissected from the thoracic inlet, the abdomen was opened for dissection of the abdominal part of the transplant. All scar tissues and strictures were excised after the transplant release, and a new anastomosis was constructed in healthy tissues. In cases involving life-threatening complications, patient survival prevailed over graft preservation and reconstruction of digestive continuity. The operations took up to 10 hours, with 8 hours, 20 minutes the median.

Dr. Voron and coauthors identified two distinct indications for CSLap: graft strictures in 43 (78%) of patients to rescue the primary conduit and reconstruct the cervical anastomosis and a need to access the retrosternal space to treat graft-related complications. “Graft lengthening was definitely not the issue in this situation,” Dr. Voron and colleagues said of the latter indication.

Four patients had emergency revision CSLap for spontaneous graft perforation and complications related to caustic reingestion. None died and one patient had preservation of the primary conduit. “Retrosternal grafts can be quickly removed by blunt dissection in life-threatening circumstances; however, if reasonable chances to recover the transplant exist, CSLap exploration can be justified,” Dr. Voron and coauthors said.

CSLap offers a few advantages in these situations: Transplant release provides significant lengthening of the graft that enables preservation of the primary conduit and redo of the cervical anastomosis in most patients, and it allows direct access to the retrosternal space if needed, Dr. Voron and coauthors said.

Dr. Voron and coauthors had no financial relationships to disclose.

[email protected]