Cardiothoracic Surgery

The investigational FORMA system seems safe and may be effective in patients with NYHA Class III/IV heart failure and severe tricuspid valve regurgitation, based on 13 first-in-human cases.

A Canadian surgical team employed the FORMA system (Edwards Lifesciences) as compassionate use therapy for a set of patients with inoperable tricuspid regurgitation. The device was successfully deployed in 12 of the 13 patients, according to data presented at the Transcatheter Cardiovascular Therapeutics annual meeting. There were no deaths or major clinical complications in any of the patients.

A report on seven of these patients was simultaneously published in the Journal of the American College of Cardiology. All of the patients had severe tricuspid regurgitation and heart failure; before surgery, six had a New York Heart Association (NYHA) Functional Classification of III/IV. By 30 days after the procedure, all had improved to NYHA II, wrote Dr. Francisco Campelo-Parada of the Quebec Heart and Lung Institute, the paper’s primary author. Peripheral edema declined and all patients experienced functional improvement, as well.

According to Edwards Lifesciences, the FORMA device uses a foam-filled polymer balloon spacer to reduce tricuspid regurgitation by occupying the regurgitant orifice area and providing a surface for the coaptation of the valve’s native leaflets. Implantation is performed via the left axillary vein.

Patients in the series were a mean of 76 years old. All had severe tricuspid regurgitation. The mean maximal vena contracta was 15.5 mm.

Six had coronary artery disease and five had previously undergone open heart surgery. Additionally, two had previously undergone mitral valve surgery and two had undergone aortic valve surgery. Pulmonary hypertension was present in five. Five patients also had persistent atrial fibrillation. Six had renal insufficiency, with one patient on dialysis. The baseline furosemide dose was 80 mg/day.

All procedures were performed under general sedation and fluoroscopic guidance, with postprocedural positioning checked by cardiac-CT and/or a chest x-ray. The mean postop stay was 4 days.

Tricuspid regurgitation was reduced by at least 1 degree in all patients during the operation; four patients had an immediate 2-degree reduction, reclassifying their regurgitation as mild. Two experienced new-onset atrial fibrillation, and one had several episodes of nonsustained ventricular tachycardia that was managed with beta-blockers.

At the first clinical follow-up 30 days after surgery, all but one patient had an improvement to Class II NYHA status.

Two patients were able to reduce their diuretic dosage; there were no other medication changes. Peripheral edema declined in the entire cohort. Tricuspid regurgitation was graded as moderate in all patients.

There were also associated improvements in quality of life, based on scores on the Kansas City Cardiomyopathy Questionnaire, which increased from 59 before surgery to 86 after surgery. Exercise capacity as measured by the 6-Minute Walk Test improved from 297 meters to 326 meters.

The authors suggested that the 15-mm spacer used in the FORMA device was not well-matched with the mean 15.5-mm vena contracta size in the cohort. Better outcomes might be possible if a larger spacer were available.

“Despite good device positioning, complete coaptation was not achieved, resulting in significant residual degree of postprocedural tricuspid regurgitation,” they said. “Also, the very advanced stage of the disease in most patients may have played a role in the mild reduction at 30 days.”

Despite the rather mild, 1-degree improvement, patients did make considerable improvements in heart failure and functional status. Therefore, the team recommended further study for FORMA, with an eye toward optimizing patient selection.

“Specific criteria for quantifying right ventricular dysfunction and pulmonary hypertension, along with novel quantitative echocardiographic imaging criteria may be required,” they said. “It is conceivable that larger than the currently available spacer sizes may be required to improve echocardiographic results in patients with large noncoaptation defects and vena contracta.”

Dr. Campelo-Parada had no financial disclosures with regard to the device.

[email protected]

The investigational FORMA system seems safe and may be effective in patients with NYHA Class III/IV heart failure and severe tricuspid valve regurgitation, based on 13 first-in-human cases.

A Canadian surgical team employed the FORMA system (Edwards Lifesciences) as compassionate use therapy for a set of patients with inoperable tricuspid regurgitation. The device was successfully deployed in 12 of the 13 patients, according to data presented at the Transcatheter Cardiovascular Therapeutics annual meeting. There were no deaths or major clinical complications in any of the patients.

A report on seven of these patients was simultaneously published in the Journal of the American College of Cardiology. All of the patients had severe tricuspid regurgitation and heart failure; before surgery, six had a New York Heart Association (NYHA) Functional Classification of III/IV. By 30 days after the procedure, all had improved to NYHA II, wrote Dr. Francisco Campelo-Parada of the Quebec Heart and Lung Institute, the paper’s primary author. Peripheral edema declined and all patients experienced functional improvement, as well.

According to Edwards Lifesciences, the FORMA device uses a foam-filled polymer balloon spacer to reduce tricuspid regurgitation by occupying the regurgitant orifice area and providing a surface for the coaptation of the valve’s native leaflets. Implantation is performed via the left axillary vein.

Patients in the series were a mean of 76 years old. All had severe tricuspid regurgitation. The mean maximal vena contracta was 15.5 mm.

Six had coronary artery disease and five had previously undergone open heart surgery. Additionally, two had previously undergone mitral valve surgery and two had undergone aortic valve surgery. Pulmonary hypertension was present in five. Five patients also had persistent atrial fibrillation. Six had renal insufficiency, with one patient on dialysis. The baseline furosemide dose was 80 mg/day.

All procedures were performed under general sedation and fluoroscopic guidance, with postprocedural positioning checked by cardiac-CT and/or a chest x-ray. The mean postop stay was 4 days.

Tricuspid regurgitation was reduced by at least 1 degree in all patients during the operation; four patients had an immediate 2-degree reduction, reclassifying their regurgitation as mild. Two experienced new-onset atrial fibrillation, and one had several episodes of nonsustained ventricular tachycardia that was managed with beta-blockers.

At the first clinical follow-up 30 days after surgery, all but one patient had an improvement to Class II NYHA status.

Two patients were able to reduce their diuretic dosage; there were no other medication changes. Peripheral edema declined in the entire cohort. Tricuspid regurgitation was graded as moderate in all patients.

There were also associated improvements in quality of life, based on scores on the Kansas City Cardiomyopathy Questionnaire, which increased from 59 before surgery to 86 after surgery. Exercise capacity as measured by the 6-Minute Walk Test improved from 297 meters to 326 meters.

The authors suggested that the 15-mm spacer used in the FORMA device was not well-matched with the mean 15.5-mm vena contracta size in the cohort. Better outcomes might be possible if a larger spacer were available.

“Despite good device positioning, complete coaptation was not achieved, resulting in significant residual degree of postprocedural tricuspid regurgitation,” they said. “Also, the very advanced stage of the disease in most patients may have played a role in the mild reduction at 30 days.”

Despite the rather mild, 1-degree improvement, patients did make considerable improvements in heart failure and functional status. Therefore, the team recommended further study for FORMA, with an eye toward optimizing patient selection.

“Specific criteria for quantifying right ventricular dysfunction and pulmonary hypertension, along with novel quantitative echocardiographic imaging criteria may be required,” they said. “It is conceivable that larger than the currently available spacer sizes may be required to improve echocardiographic results in patients with large noncoaptation defects and vena contracta.”

Dr. Campelo-Parada had no financial disclosures with regard to the device.

[email protected]

The investigational FORMA system seems safe and may be effective in patients with NYHA Class III/IV heart failure and severe tricuspid valve regurgitation, based on 13 first-in-human cases.

A Canadian surgical team employed the FORMA system (Edwards Lifesciences) as compassionate use therapy for a set of patients with inoperable tricuspid regurgitation. The device was successfully deployed in 12 of the 13 patients, according to data presented at the Transcatheter Cardiovascular Therapeutics annual meeting. There were no deaths or major clinical complications in any of the patients.

A report on seven of these patients was simultaneously published in the Journal of the American College of Cardiology. All of the patients had severe tricuspid regurgitation and heart failure; before surgery, six had a New York Heart Association (NYHA) Functional Classification of III/IV. By 30 days after the procedure, all had improved to NYHA II, wrote Dr. Francisco Campelo-Parada of the Quebec Heart and Lung Institute, the paper’s primary author. Peripheral edema declined and all patients experienced functional improvement, as well.

According to Edwards Lifesciences, the FORMA device uses a foam-filled polymer balloon spacer to reduce tricuspid regurgitation by occupying the regurgitant orifice area and providing a surface for the coaptation of the valve’s native leaflets. Implantation is performed via the left axillary vein.

Patients in the series were a mean of 76 years old. All had severe tricuspid regurgitation. The mean maximal vena contracta was 15.5 mm.

Six had coronary artery disease and five had previously undergone open heart surgery. Additionally, two had previously undergone mitral valve surgery and two had undergone aortic valve surgery. Pulmonary hypertension was present in five. Five patients also had persistent atrial fibrillation. Six had renal insufficiency, with one patient on dialysis. The baseline furosemide dose was 80 mg/day.

All procedures were performed under general sedation and fluoroscopic guidance, with postprocedural positioning checked by cardiac-CT and/or a chest x-ray. The mean postop stay was 4 days.

Tricuspid regurgitation was reduced by at least 1 degree in all patients during the operation; four patients had an immediate 2-degree reduction, reclassifying their regurgitation as mild. Two experienced new-onset atrial fibrillation, and one had several episodes of nonsustained ventricular tachycardia that was managed with beta-blockers.

At the first clinical follow-up 30 days after surgery, all but one patient had an improvement to Class II NYHA status.

Two patients were able to reduce their diuretic dosage; there were no other medication changes. Peripheral edema declined in the entire cohort. Tricuspid regurgitation was graded as moderate in all patients.

There were also associated improvements in quality of life, based on scores on the Kansas City Cardiomyopathy Questionnaire, which increased from 59 before surgery to 86 after surgery. Exercise capacity as measured by the 6-Minute Walk Test improved from 297 meters to 326 meters.

The authors suggested that the 15-mm spacer used in the FORMA device was not well-matched with the mean 15.5-mm vena contracta size in the cohort. Better outcomes might be possible if a larger spacer were available.

“Despite good device positioning, complete coaptation was not achieved, resulting in significant residual degree of postprocedural tricuspid regurgitation,” they said. “Also, the very advanced stage of the disease in most patients may have played a role in the mild reduction at 30 days.”

Despite the rather mild, 1-degree improvement, patients did make considerable improvements in heart failure and functional status. Therefore, the team recommended further study for FORMA, with an eye toward optimizing patient selection.

“Specific criteria for quantifying right ventricular dysfunction and pulmonary hypertension, along with novel quantitative echocardiographic imaging criteria may be required,” they said. “It is conceivable that larger than the currently available spacer sizes may be required to improve echocardiographic results in patients with large noncoaptation defects and vena contracta.”

Dr. Campelo-Parada had no financial disclosures with regard to the device.

[email protected]

CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.

Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).

The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.

The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”

Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.

Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.

Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.

The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.

The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.

Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.

The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.

The investigators have no relevant disclosures.

[email protected]

CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.

Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).

The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.

The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”

Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.

Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.

Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.

The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.

The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.

Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.

The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.

The investigators have no relevant disclosures.

[email protected]

CHICAGO – A few simple baseline variables predict if heart surgery patients will need early nutritional support after their operations, based on a review of more than 1,000 cardiac surgery patients from Johns Hopkins Hospital in Baltimore.

Nonelective surgery and a cardiopulmonary bypass time of 100 minutes or more, plus five preop variables – previous cardiac interventions; total albumin below 4 g/dL; total bilirubin at or above 1.2 mg/dL; white blood cell counts at or above 11,000/mcL; and hematocrit below 27% – predict the need for nutrition in the first few days after cardiac surgery, they found (J Am Coll Surg. 2015 Oct: 221[4];e70).

The Hopkins team has combined those factors into a risk score, with 4 points assigned for low albumin, 6 points for nonelective surgery, 6 points for low hematocrit, and 5 points for the other four variables, yielding a maximum score of 36 points.

The researchers developed the system after discovering that it sometimes took more than a week for cardiac patients who needed postop nutrition to get it. About 40% of patients with scores of 20 or higher will need early nutritional support, and those heart patients are now the ones at Hopkins who get a nutrition consult as soon as they return from the operating room, said Dr. Rika Ohkuma, a general surgery research fellow at Johns Hopkins. “The score can be used for risk stratification and has potential quality improvement implications related to early initiation of nutritional support in high-risk patients.”

Just 2% of patients who score 10 points or below need early nutrition, so consults are less pressing. About 9% of patients who score from 10-20 points will require nutrition, so consults are at the discretion of the physician, the investigators concluded.

Those insights came from a review of 1,056 adult heart cases in 2012. Just 87 patients (8%) had a postop consult for nutritional support. Most wound up with enteral feedings, but they started an average of 5 days after surgery. The handful that needed both parenteral and enteric feedings started them an average of 7 days after surgery.

Meanwhile, those 87 patients had significantly higher hospital mortality (29% vs. 3%), ventilator time (278 vs. 20 hours), and gastrointestinal complications (32% vs. 5%), and fewer discharges to home (49% vs. 84%) than did other patients.

The team thought that the delay in feeding might have had something to do with the poor outcomes, so “we tried to improve our behavior. We know that nutrition is beneficial for critically ill patients and that we need to start early, but there was no gold standard for when to start,” Dr. Ohkuma said.

The investigators came up with the risk score after figuring out how patients who needed nutrition differed from those who did not. They found, for example, that patients who have emergent surgery were more than three times as likely to have a nutrition consult than were those who had elective procedures.

Now when patients are admitted to the ICU after cardiac surgery, “we all know their [nutrition] score; if they are likely to need support, we immediately call the nutritional support service for a consult.” Patients no longer have to wait, Dr. Ohkuma said.

The researchers launched a prospective study in January 2015. Nutritional needs were addressed sooner, at about postop day 4, for the 70 patients who have needed, and mortality seems to be dropping.

The investigators have no relevant disclosures.

[email protected]

BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.

“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.

Dr. Patterson had no relevant disclosures.

[email protected]

BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.

“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.

Dr. Patterson had no relevant disclosures.

[email protected]

BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.

“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.

Dr. Patterson had no relevant disclosures.

[email protected]

BOSTON – When it comes to intraoperative complications during thoracoscopic lobectomy, the mantra for success is to always have a preoperative plan, but be flexible enough to improvise should anything out of the norm arise.

“Many surgeons, when they ask [me] about this specific topic, ask what specific tricks [I] have, but I don’t like to use the word ‘trick’ [because] it’s not something we can do that other people can’t,” explained Dr. Thomas A. D’Amico, chief of general thoracic surgery at Duke University in Durham, North Carolina.

“It’s really just about strategy – how you start an operation, what the conduct of it should be, and when you see things that are less common or more difficult cases, how you think about those and manage those.”

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting held by the American Association for Thoracic Surgeons, Dr. D’Amico talked about why surgeons around the world are apprehensive about thoracoscopic lobectomy and why it’s important to begin training residents on how to properly perform the procedure as soon as possible, as it helps mitigate uncertainty while giving them valuable experience to solve any issues that may come up during an operation.

Dr. D’Amico disclosed that he is a consultant for Scanlan, but that it is not relevant to this discussion.

[email protected]

BOSTON – When it comes to intraoperative complications during thoracoscopic lobectomy, the mantra for success is to always have a preoperative plan, but be flexible enough to improvise should anything out of the norm arise.

“Many surgeons, when they ask [me] about this specific topic, ask what specific tricks [I] have, but I don’t like to use the word ‘trick’ [because] it’s not something we can do that other people can’t,” explained Dr. Thomas A. D’Amico, chief of general thoracic surgery at Duke University in Durham, North Carolina.

“It’s really just about strategy – how you start an operation, what the conduct of it should be, and when you see things that are less common or more difficult cases, how you think about those and manage those.”

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting held by the American Association for Thoracic Surgeons, Dr. D’Amico talked about why surgeons around the world are apprehensive about thoracoscopic lobectomy and why it’s important to begin training residents on how to properly perform the procedure as soon as possible, as it helps mitigate uncertainty while giving them valuable experience to solve any issues that may come up during an operation.

Dr. D’Amico disclosed that he is a consultant for Scanlan, but that it is not relevant to this discussion.

[email protected]

BOSTON – When it comes to intraoperative complications during thoracoscopic lobectomy, the mantra for success is to always have a preoperative plan, but be flexible enough to improvise should anything out of the norm arise.

“Many surgeons, when they ask [me] about this specific topic, ask what specific tricks [I] have, but I don’t like to use the word ‘trick’ [because] it’s not something we can do that other people can’t,” explained Dr. Thomas A. D’Amico, chief of general thoracic surgery at Duke University in Durham, North Carolina.

“It’s really just about strategy – how you start an operation, what the conduct of it should be, and when you see things that are less common or more difficult cases, how you think about those and manage those.”

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting held by the American Association for Thoracic Surgeons, Dr. D’Amico talked about why surgeons around the world are apprehensive about thoracoscopic lobectomy and why it’s important to begin training residents on how to properly perform the procedure as soon as possible, as it helps mitigate uncertainty while giving them valuable experience to solve any issues that may come up during an operation.

Dr. D’Amico disclosed that he is a consultant for Scanlan, but that it is not relevant to this discussion.

[email protected]

As a “minimalist” approach to transcatheter aortic valve replacement – known as MA-TAVR – gains in popularity at high-volume centers, questions persist about the surgeon’s learning curve. A small series of MA-TAVR cases at Emory University in Atlanta has shown that the leaning curve may be like the TAVR approach itself: minimal.

Dr. Hanna Jensen and her associates reported on 151 consecutive patients who had MA-TAVR in the October issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.078). They previously reported their findings at the annual meeting of the American Association for Thoracic Surgery in April in Seattle.

This study builds on an Emory study last year that reported the minimalist approach to TAVR cost about $10,000 less per patient than the standard transfemoral approach (JACC Cardiovasc Interv. 2014;7:898-904).

The operation the study authors evaluated is performed in the catheterization laboratory rather than the operating room, as in traditional TAVR. Both approaches use a femoral approach, but where traditional TAVR requires general anesthesia and transesophageal echocardiography (TEE), MA-TAVR uses local anesthesia, minimal conscious sedation, and transthoracic echocardiography (TTE).

The study authors acknowledged concerns that TTE may underestimate the severity of paravalvular leak after the procedure when compared with TEE. Their protocol relies on preoperative TTE and CT scans, or three-dimensional TEE if the case warrants it, to ensure optimal sizing of the transcatheter valve before the operation. “If any concerns arise, our threshold is low to perform intraoperative balloon-sizing,” Dr. Jensen and her coauthors said. They also use TTE, along with a root-angiogram after valve deployment, and invasively measure the aortic regurgitation index before and after deployment.

Most study patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score of 10%. The overall major stroke rate was 3.3%, while major vascular complications occurred in 3% of patients and the greater-than-mild paravalvular leak rate was 7%.

The study retrospectively evaluated 151 consecutive patients who were divided into three groups at different time points: May 2012 to January 2013, February to August 2013, and September 2013 to July 2014. Complications were similar among all three groups, but the third group had shorter hospital stays and less time in the intensive care unit (ICU).

The first group received only the first-generation SAPIEN valve system; use of the second-generation SAPIEN XT valve increased in latter two groups. The SAPIEN XT valve is available in 23, 26, or 29 mm, but the 29-mm size was not available in the first-generation SAPIEN implant.

A subgroup analysis looked at patients who were discharged within 48 hours of the operation or more than 48 hours afterward. The early-discharge patients had lower STS PROM scores (8.3% vs. 10.3%) and lower rates of diabetes (31% vs. 49%). They also had less need for postoperative pacemakers and less frequent rehospitalization. “This implies that in selected MA-TAVR patients early discharge is feasible and safe, but larger studies are required to identify the optimal profile of patients who can be sent home within the first two postoperative days,” Dr. Jensen and her colleagues said.

Early in the MA-TAVR protocol all patients were sent to the ICU. As the care team gained more experience with the procedure, the protocol changed to send all patients to a regular telemetry floor after surgery unless they had vascular issues or potential need for a pacemaker. The decreasing need for ICU “was the only indication of an institutional learning curve that was discovered, and demonstrated improved resource utilization over time,” the investigators said.

They encouraged other centers to pursue MA-TAVR. “As experience grows, we believe that this procedure can be done with less or no ICU support leading to a shorter hospital stay and improved resource utilization,” Dr. Jensen and her coauthors concluded. They called for further studies to determine the characteristics that make a patient most suitable for a short-admission MA-TAVR procedure.

Study coauthors Dr. Vasilis Babaliaros, Dr. Vinod Thourani, Amy Simone, and Patricia Keegan are research consultants with Edwards Lifesciences. The rest of the authors had no disclosures.

As a “minimalist” approach to transcatheter aortic valve replacement – known as MA-TAVR – gains in popularity at high-volume centers, questions persist about the surgeon’s learning curve. A small series of MA-TAVR cases at Emory University in Atlanta has shown that the leaning curve may be like the TAVR approach itself: minimal.

Dr. Hanna Jensen and her associates reported on 151 consecutive patients who had MA-TAVR in the October issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.078). They previously reported their findings at the annual meeting of the American Association for Thoracic Surgery in April in Seattle.

This study builds on an Emory study last year that reported the minimalist approach to TAVR cost about $10,000 less per patient than the standard transfemoral approach (JACC Cardiovasc Interv. 2014;7:898-904).

The operation the study authors evaluated is performed in the catheterization laboratory rather than the operating room, as in traditional TAVR. Both approaches use a femoral approach, but where traditional TAVR requires general anesthesia and transesophageal echocardiography (TEE), MA-TAVR uses local anesthesia, minimal conscious sedation, and transthoracic echocardiography (TTE).

The study authors acknowledged concerns that TTE may underestimate the severity of paravalvular leak after the procedure when compared with TEE. Their protocol relies on preoperative TTE and CT scans, or three-dimensional TEE if the case warrants it, to ensure optimal sizing of the transcatheter valve before the operation. “If any concerns arise, our threshold is low to perform intraoperative balloon-sizing,” Dr. Jensen and her coauthors said. They also use TTE, along with a root-angiogram after valve deployment, and invasively measure the aortic regurgitation index before and after deployment.

Most study patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score of 10%. The overall major stroke rate was 3.3%, while major vascular complications occurred in 3% of patients and the greater-than-mild paravalvular leak rate was 7%.

The study retrospectively evaluated 151 consecutive patients who were divided into three groups at different time points: May 2012 to January 2013, February to August 2013, and September 2013 to July 2014. Complications were similar among all three groups, but the third group had shorter hospital stays and less time in the intensive care unit (ICU).

The first group received only the first-generation SAPIEN valve system; use of the second-generation SAPIEN XT valve increased in latter two groups. The SAPIEN XT valve is available in 23, 26, or 29 mm, but the 29-mm size was not available in the first-generation SAPIEN implant.

A subgroup analysis looked at patients who were discharged within 48 hours of the operation or more than 48 hours afterward. The early-discharge patients had lower STS PROM scores (8.3% vs. 10.3%) and lower rates of diabetes (31% vs. 49%). They also had less need for postoperative pacemakers and less frequent rehospitalization. “This implies that in selected MA-TAVR patients early discharge is feasible and safe, but larger studies are required to identify the optimal profile of patients who can be sent home within the first two postoperative days,” Dr. Jensen and her colleagues said.

Early in the MA-TAVR protocol all patients were sent to the ICU. As the care team gained more experience with the procedure, the protocol changed to send all patients to a regular telemetry floor after surgery unless they had vascular issues or potential need for a pacemaker. The decreasing need for ICU “was the only indication of an institutional learning curve that was discovered, and demonstrated improved resource utilization over time,” the investigators said.

They encouraged other centers to pursue MA-TAVR. “As experience grows, we believe that this procedure can be done with less or no ICU support leading to a shorter hospital stay and improved resource utilization,” Dr. Jensen and her coauthors concluded. They called for further studies to determine the characteristics that make a patient most suitable for a short-admission MA-TAVR procedure.

Study coauthors Dr. Vasilis Babaliaros, Dr. Vinod Thourani, Amy Simone, and Patricia Keegan are research consultants with Edwards Lifesciences. The rest of the authors had no disclosures.

As a “minimalist” approach to transcatheter aortic valve replacement – known as MA-TAVR – gains in popularity at high-volume centers, questions persist about the surgeon’s learning curve. A small series of MA-TAVR cases at Emory University in Atlanta has shown that the leaning curve may be like the TAVR approach itself: minimal.

Dr. Hanna Jensen and her associates reported on 151 consecutive patients who had MA-TAVR in the October issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015. doi: 10.1016/j.jtcvs.2015.07.078). They previously reported their findings at the annual meeting of the American Association for Thoracic Surgery in April in Seattle.

This study builds on an Emory study last year that reported the minimalist approach to TAVR cost about $10,000 less per patient than the standard transfemoral approach (JACC Cardiovasc Interv. 2014;7:898-904).

The operation the study authors evaluated is performed in the catheterization laboratory rather than the operating room, as in traditional TAVR. Both approaches use a femoral approach, but where traditional TAVR requires general anesthesia and transesophageal echocardiography (TEE), MA-TAVR uses local anesthesia, minimal conscious sedation, and transthoracic echocardiography (TTE).

The study authors acknowledged concerns that TTE may underestimate the severity of paravalvular leak after the procedure when compared with TEE. Their protocol relies on preoperative TTE and CT scans, or three-dimensional TEE if the case warrants it, to ensure optimal sizing of the transcatheter valve before the operation. “If any concerns arise, our threshold is low to perform intraoperative balloon-sizing,” Dr. Jensen and her coauthors said. They also use TTE, along with a root-angiogram after valve deployment, and invasively measure the aortic regurgitation index before and after deployment.

Most study patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score of 10%. The overall major stroke rate was 3.3%, while major vascular complications occurred in 3% of patients and the greater-than-mild paravalvular leak rate was 7%.

The study retrospectively evaluated 151 consecutive patients who were divided into three groups at different time points: May 2012 to January 2013, February to August 2013, and September 2013 to July 2014. Complications were similar among all three groups, but the third group had shorter hospital stays and less time in the intensive care unit (ICU).

The first group received only the first-generation SAPIEN valve system; use of the second-generation SAPIEN XT valve increased in latter two groups. The SAPIEN XT valve is available in 23, 26, or 29 mm, but the 29-mm size was not available in the first-generation SAPIEN implant.

A subgroup analysis looked at patients who were discharged within 48 hours of the operation or more than 48 hours afterward. The early-discharge patients had lower STS PROM scores (8.3% vs. 10.3%) and lower rates of diabetes (31% vs. 49%). They also had less need for postoperative pacemakers and less frequent rehospitalization. “This implies that in selected MA-TAVR patients early discharge is feasible and safe, but larger studies are required to identify the optimal profile of patients who can be sent home within the first two postoperative days,” Dr. Jensen and her colleagues said.

Early in the MA-TAVR protocol all patients were sent to the ICU. As the care team gained more experience with the procedure, the protocol changed to send all patients to a regular telemetry floor after surgery unless they had vascular issues or potential need for a pacemaker. The decreasing need for ICU “was the only indication of an institutional learning curve that was discovered, and demonstrated improved resource utilization over time,” the investigators said.

They encouraged other centers to pursue MA-TAVR. “As experience grows, we believe that this procedure can be done with less or no ICU support leading to a shorter hospital stay and improved resource utilization,” Dr. Jensen and her coauthors concluded. They called for further studies to determine the characteristics that make a patient most suitable for a short-admission MA-TAVR procedure.

Study coauthors Dr. Vasilis Babaliaros, Dr. Vinod Thourani, Amy Simone, and Patricia Keegan are research consultants with Edwards Lifesciences. The rest of the authors had no disclosures.

The American Society for Radiation Oncology (ASTRO) has selected leading surgeon and researcher Jack A. Roth, MD, FCCP, as the 2015 Honorary Member, the highest honor ASTRO bestows on distinguished cancer researchers, scientists, and leaders in disciplines other than radiation oncology, radiobiology, or radiation physics. Dr. Roth will be inducted as the 2015 ASTRO Honorary Member during the Awards Ceremony in October, at ASTRO’s 57th Annual Meeting, in San Antonio.

Dr. Roth is professor, Department of Thoracic and Cardiovascular Surgery, Division of Surgery, MD Anderson Cancer Center, Houston, and chief, Section of Thoracic Molecular Oncology, Department of Thoracic and Cardiovascular Surgery, Division of Surgery, MD Anderson Cancer Center, Houston.

He cited his and colleagues’ study “Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomized trials,” published in Lancet Oncology in May 2015, as his most recent career highlight. Dr. Roth was an early innovator in the development of gene therapy for cancer, and led the first tumor suppressor gene therapy clinical trials approved by the National Institutes of Health Recombinant DNA Advisory Committee and the U.S. Food and Drug Administration. His work was the first gene therapy in cancer approved for human use.

The American Society for Radiation Oncology (ASTRO) has selected leading surgeon and researcher Jack A. Roth, MD, FCCP, as the 2015 Honorary Member, the highest honor ASTRO bestows on distinguished cancer researchers, scientists, and leaders in disciplines other than radiation oncology, radiobiology, or radiation physics. Dr. Roth will be inducted as the 2015 ASTRO Honorary Member during the Awards Ceremony in October, at ASTRO’s 57th Annual Meeting, in San Antonio.

Dr. Roth is professor, Department of Thoracic and Cardiovascular Surgery, Division of Surgery, MD Anderson Cancer Center, Houston, and chief, Section of Thoracic Molecular Oncology, Department of Thoracic and Cardiovascular Surgery, Division of Surgery, MD Anderson Cancer Center, Houston.

He cited his and colleagues’ study “Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomized trials,” published in Lancet Oncology in May 2015, as his most recent career highlight. Dr. Roth was an early innovator in the development of gene therapy for cancer, and led the first tumor suppressor gene therapy clinical trials approved by the National Institutes of Health Recombinant DNA Advisory Committee and the U.S. Food and Drug Administration. His work was the first gene therapy in cancer approved for human use.

The American Society for Radiation Oncology (ASTRO) has selected leading surgeon and researcher Jack A. Roth, MD, FCCP, as the 2015 Honorary Member, the highest honor ASTRO bestows on distinguished cancer researchers, scientists, and leaders in disciplines other than radiation oncology, radiobiology, or radiation physics. Dr. Roth will be inducted as the 2015 ASTRO Honorary Member during the Awards Ceremony in October, at ASTRO’s 57th Annual Meeting, in San Antonio.

Dr. Roth is professor, Department of Thoracic and Cardiovascular Surgery, Division of Surgery, MD Anderson Cancer Center, Houston, and chief, Section of Thoracic Molecular Oncology, Department of Thoracic and Cardiovascular Surgery, Division of Surgery, MD Anderson Cancer Center, Houston.

He cited his and colleagues’ study “Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomized trials,” published in Lancet Oncology in May 2015, as his most recent career highlight. Dr. Roth was an early innovator in the development of gene therapy for cancer, and led the first tumor suppressor gene therapy clinical trials approved by the National Institutes of Health Recombinant DNA Advisory Committee and the U.S. Food and Drug Administration. His work was the first gene therapy in cancer approved for human use.

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

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

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

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

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

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

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

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

Dr. Meknat reported having no financial disclosures.

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

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

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

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

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

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

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

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

Dr. Meknat reported having no financial disclosures.

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

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

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

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

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

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

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

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

Dr. Meknat reported having no financial disclosures.

Attending physicians who work through the wee hours of the night do not have measurably different short-term outcomes for elective surgeries performed the next day, according to a population-based, matched-control study published online Aug. 26.

The primary composite outcome of death, readmission, or complications within 30 days occurred in 22.2% of patients undergoing elective daytime surgery by an attending who treated patients from midnight to 7 a.m. and in 22.4% of those undergoing the same procedure by the same attending, but after a night when no clinical work had been performed (P = .66).

©monkeybusinessimages/Thinkstock.com

There was no significant between-group difference in the primary outcome in adjusted analyses (adjusted odds ratio, 0.99; P = .65).

Secondary outcomes also were similar between the postmidnight and control groups: death within 30 days (both 1.1%), readmission within 30 days (6.6% vs. 7.1%), complications within 30 days (18.1% vs. 18.2%), median length of stay (both 3 days), and median duration of surgery (both 2.6 hours).

“These data suggest that calls for broad-based policy shifts in duty hours and practices of attending surgeons may not be necessary at this time,” wrote surgical oncologist Dr. Anand Govindarajan of Mount Sinai Hospital, Toronto, and his associates (N Engl J Med. 2015;373:845-53. doi: 10.1056/NEJMsa1415994).

The current study addresses a gap in the literature on the effects of sleep deprivation and may help inform policy discussions on this issue, the authors suggested.

Most studies of physicians suggesting that sleep deprivation may affect mood, cognition, and psycho-motor function have focused on medical trainees, but few studies have examined the effects of sleep deprivation in attending physicians and the results have been conflicting.

A 2009 single-center study prompted calls for policy-level changes regarding sleep deprivation in surgeons after showing a higher rate of complications for procedures performed by attending physicians with sleep opportunities of less than 6 hours (JAMA. 2009 Oct 14;302[14]:1565-72), but the findings have not been replicated by other groups, Dr. Govindarajan and his associates observed.

In the current study, a small but significant increase in complications was observed in the subset of patients whose physician had performed two or more procedures the night before (adjusted OR, 1.14; P = .05). Importantly, this isolated finding was from a post-hoc subgroup analysis and may be the result of random error, they suggested.

Further, three a priori analyses found no significant difference in outcomes after stratification for academic vs. nonacademic center, physician age, or type of procedure.

The current study involved 38,978 patients who underwent 1 of 12 elective daytime procedures performed by 1,448 physicians at 147 hospitals in Ontario. Patients undergoing procedures performed by a physician who had treated patients from midnight to 7 a.m. were matched in a 1:1 ratio to patients undergoing the same procedure by the same physician on a day when the physician had not treated patients after midnight.

The physicians had been in practice for a median of 20 years, and 40.6% of procedures were performed at academic institutions. Physicians who treated patients after midnight performed a mean of 1.25 procedures during that time.

The elective procedures (cholecystectomy, gastric bypass, colon resection, coronary artery bypass grafting, coronary angioplasty, knee replacement, hip replacement, hip fracture repair, hysterectomy, spinal surgery, craniotomy, and lung resection) were all performed on weekdays.

The investigators selected procedures that varied in duration and were associated with a range of complication rates because sleep studies have suggested that tasks requiring longer periods of concentration may be more affected by sleep deprivation.

“The broad scope of the study enhances its generalizability, a particularly relevant consideration if policy changes are being contemplated with respect to duty hours,” Dr. Govindarajan and his associates noted.

Other strengths of the study are the matched study groups and sufficiently sized cohorts and event rates to provide adequate power to show clinically meaningful differences.

Limitations of the study are the inability to quantify the number of hours that a physician was deprived of sleep and to determine whether there was a difference in outcomes between daytime procedures performed later in the day and those performed earlier in the day or whether procedures may have been postponed till later in the day because of substantial sleep deprivation. “However, given the constraints of operating room schedules in Ontario, it would not usually be feasible to postpone an operation until later in the day on short notice,” the investigators wrote.

Dr. Govindarajan reported grant support from the Canadian Institutes for Health Research and the University of Toronto Dean’s Fund while conducting the study.

[email protected]

On Twitter @pwendl

Attending physicians who work through the wee hours of the night do not have measurably different short-term outcomes for elective surgeries performed the next day, according to a population-based, matched-control study published online Aug. 26.

The primary composite outcome of death, readmission, or complications within 30 days occurred in 22.2% of patients undergoing elective daytime surgery by an attending who treated patients from midnight to 7 a.m. and in 22.4% of those undergoing the same procedure by the same attending, but after a night when no clinical work had been performed (P = .66).

©monkeybusinessimages/Thinkstock.com

There was no significant between-group difference in the primary outcome in adjusted analyses (adjusted odds ratio, 0.99; P = .65).

Secondary outcomes also were similar between the postmidnight and control groups: death within 30 days (both 1.1%), readmission within 30 days (6.6% vs. 7.1%), complications within 30 days (18.1% vs. 18.2%), median length of stay (both 3 days), and median duration of surgery (both 2.6 hours).

“These data suggest that calls for broad-based policy shifts in duty hours and practices of attending surgeons may not be necessary at this time,” wrote surgical oncologist Dr. Anand Govindarajan of Mount Sinai Hospital, Toronto, and his associates (N Engl J Med. 2015;373:845-53. doi: 10.1056/NEJMsa1415994).

The current study addresses a gap in the literature on the effects of sleep deprivation and may help inform policy discussions on this issue, the authors suggested.

Most studies of physicians suggesting that sleep deprivation may affect mood, cognition, and psycho-motor function have focused on medical trainees, but few studies have examined the effects of sleep deprivation in attending physicians and the results have been conflicting.

A 2009 single-center study prompted calls for policy-level changes regarding sleep deprivation in surgeons after showing a higher rate of complications for procedures performed by attending physicians with sleep opportunities of less than 6 hours (JAMA. 2009 Oct 14;302[14]:1565-72), but the findings have not been replicated by other groups, Dr. Govindarajan and his associates observed.

In the current study, a small but significant increase in complications was observed in the subset of patients whose physician had performed two or more procedures the night before (adjusted OR, 1.14; P = .05). Importantly, this isolated finding was from a post-hoc subgroup analysis and may be the result of random error, they suggested.

Further, three a priori analyses found no significant difference in outcomes after stratification for academic vs. nonacademic center, physician age, or type of procedure.

The current study involved 38,978 patients who underwent 1 of 12 elective daytime procedures performed by 1,448 physicians at 147 hospitals in Ontario. Patients undergoing procedures performed by a physician who had treated patients from midnight to 7 a.m. were matched in a 1:1 ratio to patients undergoing the same procedure by the same physician on a day when the physician had not treated patients after midnight.

The physicians had been in practice for a median of 20 years, and 40.6% of procedures were performed at academic institutions. Physicians who treated patients after midnight performed a mean of 1.25 procedures during that time.

The elective procedures (cholecystectomy, gastric bypass, colon resection, coronary artery bypass grafting, coronary angioplasty, knee replacement, hip replacement, hip fracture repair, hysterectomy, spinal surgery, craniotomy, and lung resection) were all performed on weekdays.

The investigators selected procedures that varied in duration and were associated with a range of complication rates because sleep studies have suggested that tasks requiring longer periods of concentration may be more affected by sleep deprivation.

“The broad scope of the study enhances its generalizability, a particularly relevant consideration if policy changes are being contemplated with respect to duty hours,” Dr. Govindarajan and his associates noted.

Other strengths of the study are the matched study groups and sufficiently sized cohorts and event rates to provide adequate power to show clinically meaningful differences.

Limitations of the study are the inability to quantify the number of hours that a physician was deprived of sleep and to determine whether there was a difference in outcomes between daytime procedures performed later in the day and those performed earlier in the day or whether procedures may have been postponed till later in the day because of substantial sleep deprivation. “However, given the constraints of operating room schedules in Ontario, it would not usually be feasible to postpone an operation until later in the day on short notice,” the investigators wrote.

Dr. Govindarajan reported grant support from the Canadian Institutes for Health Research and the University of Toronto Dean’s Fund while conducting the study.

[email protected]

On Twitter @pwendl

Attending physicians who work through the wee hours of the night do not have measurably different short-term outcomes for elective surgeries performed the next day, according to a population-based, matched-control study published online Aug. 26.

The primary composite outcome of death, readmission, or complications within 30 days occurred in 22.2% of patients undergoing elective daytime surgery by an attending who treated patients from midnight to 7 a.m. and in 22.4% of those undergoing the same procedure by the same attending, but after a night when no clinical work had been performed (P = .66).

©monkeybusinessimages/Thinkstock.com

There was no significant between-group difference in the primary outcome in adjusted analyses (adjusted odds ratio, 0.99; P = .65).

Secondary outcomes also were similar between the postmidnight and control groups: death within 30 days (both 1.1%), readmission within 30 days (6.6% vs. 7.1%), complications within 30 days (18.1% vs. 18.2%), median length of stay (both 3 days), and median duration of surgery (both 2.6 hours).

“These data suggest that calls for broad-based policy shifts in duty hours and practices of attending surgeons may not be necessary at this time,” wrote surgical oncologist Dr. Anand Govindarajan of Mount Sinai Hospital, Toronto, and his associates (N Engl J Med. 2015;373:845-53. doi: 10.1056/NEJMsa1415994).

The current study addresses a gap in the literature on the effects of sleep deprivation and may help inform policy discussions on this issue, the authors suggested.

Most studies of physicians suggesting that sleep deprivation may affect mood, cognition, and psycho-motor function have focused on medical trainees, but few studies have examined the effects of sleep deprivation in attending physicians and the results have been conflicting.

A 2009 single-center study prompted calls for policy-level changes regarding sleep deprivation in surgeons after showing a higher rate of complications for procedures performed by attending physicians with sleep opportunities of less than 6 hours (JAMA. 2009 Oct 14;302[14]:1565-72), but the findings have not been replicated by other groups, Dr. Govindarajan and his associates observed.

In the current study, a small but significant increase in complications was observed in the subset of patients whose physician had performed two or more procedures the night before (adjusted OR, 1.14; P = .05). Importantly, this isolated finding was from a post-hoc subgroup analysis and may be the result of random error, they suggested.

Further, three a priori analyses found no significant difference in outcomes after stratification for academic vs. nonacademic center, physician age, or type of procedure.

The current study involved 38,978 patients who underwent 1 of 12 elective daytime procedures performed by 1,448 physicians at 147 hospitals in Ontario. Patients undergoing procedures performed by a physician who had treated patients from midnight to 7 a.m. were matched in a 1:1 ratio to patients undergoing the same procedure by the same physician on a day when the physician had not treated patients after midnight.

The physicians had been in practice for a median of 20 years, and 40.6% of procedures were performed at academic institutions. Physicians who treated patients after midnight performed a mean of 1.25 procedures during that time.

The elective procedures (cholecystectomy, gastric bypass, colon resection, coronary artery bypass grafting, coronary angioplasty, knee replacement, hip replacement, hip fracture repair, hysterectomy, spinal surgery, craniotomy, and lung resection) were all performed on weekdays.

The investigators selected procedures that varied in duration and were associated with a range of complication rates because sleep studies have suggested that tasks requiring longer periods of concentration may be more affected by sleep deprivation.

“The broad scope of the study enhances its generalizability, a particularly relevant consideration if policy changes are being contemplated with respect to duty hours,” Dr. Govindarajan and his associates noted.

Other strengths of the study are the matched study groups and sufficiently sized cohorts and event rates to provide adequate power to show clinically meaningful differences.

Limitations of the study are the inability to quantify the number of hours that a physician was deprived of sleep and to determine whether there was a difference in outcomes between daytime procedures performed later in the day and those performed earlier in the day or whether procedures may have been postponed till later in the day because of substantial sleep deprivation. “However, given the constraints of operating room schedules in Ontario, it would not usually be feasible to postpone an operation until later in the day on short notice,” the investigators wrote.

Dr. Govindarajan reported grant support from the Canadian Institutes for Health Research and the University of Toronto Dean’s Fund while conducting the study.

[email protected]

On Twitter @pwendl

Immediate and continued life-sustaining improvement was seen in three pediatric patients implanted with 3-D–printed tracheobronchial splints as a treatment for terminal tracheobronchomalacia (TBM), a condition of excessive collapse of the airways during respiration leading to cardiopulmonary arrest.

The particular value of such 3-D–printable biomaterials to pediatric surgery is their ability to adopt a 4-D modality – to exhibit specifically engineered shape changes in response to surrounding tissue growth over a defined time period. In addition to their malleability, these devices also are designed to biodegrade. These features have proven especially useful as seen in this medical device emergency use exemption study performed at the University of Michigan, according to a report published in Science Translational Medicine (2015 Apr 29. [doi: 10.1126/scitranslmed.3010825]).

“Our multidisciplinary team designed an archetype device to allow radial expansion of the affected airway over the critical growth period while resisting external compression and intrinsic collapse,” wrote Dr. Robert J. Morrison of the University of Michigan, Ann Arbor, and his colleagues.

The study population involved three infant boys, aged 3 months, 5 months, and 16 months at time of treatment. In each patient, a sternotomy exposed their affected airways. The 3-D–printed splint, consisting of conjoined rib-like C-shaped arches was placed around the affected airway and secured with polypropylene sutures. The splint counters external pressure on the airway and holds it open. Because the splint is malleable, with an expandable opening placed opposite to the main collapsing pressure, it is capable of expanding as the airway grows.

Examination of the airway immediately after placement demonstrated patency, which was confirmed 1 month later. Results showed the benefit of the splints for all three patients, although total results were complicated by additional comorbidities:

• Patient 1: Blood gases returned to normal immediately after implantation and remained normal at 3 months’ follow-up. A week after implantation, weaning from mechanical ventilation was initiated and, 3 weeks after the procedure, the child was discharged to home. Repeat imaging at 1, 3, 6, 12, and 39 months postoperatively demonstrated continued resolution of the TBM, with evidence of fragmentation and degradation of the splint at 39 months.

• Patient 2: Immediately after implantation of the device, blood gases improved greatly and the left lung perfused. The patient had opioid and benzodiazepine dependence from long-term ventilator support, requiring a longer controlled wean from the ventilator. Four weeks after surgery, the patient was transitioned to a portable ventilator system, completely weaned at 15 weeks, and discharged from the hospital to home for the first time in his life.

• Patient 3: After implantation, the patient ceased experiencing life-threatening desaturation episodes and showed sustained improvement in blood gases. Imaging showed continued patency of the left main bronchus with resolution of left-lung air trapping. However, at 14 months post implantation, he remained on permanent ventilator support, “presumably because of distal left segmental bronchomalacia beyond what the splint was designed to address,” according to Dr. Morrison and his colleagues.

“We report successful implantation of patient-specific bioresorbable airway splints for the treatment of severe TBM. The personalized splints conformed to the patients’ individual geometries and expanded with airway growth (in the ‘fourth dimension’),” the researchers summarized.

“The three pediatric patients implanted with these 3-D–printed airway splints had a terminal form of TBM. The clinical improvement in each case was immediate and sustained, suggesting that improvement is not attributable to the natural history of the disease alone,” they concluded.

The study was funded by the National Institutes of Health. Two of the study authors were coinventors of the device for which they have filed a patent. There were no other disclosures.

[email protected]

Immediate and continued life-sustaining improvement was seen in three pediatric patients implanted with 3-D–printed tracheobronchial splints as a treatment for terminal tracheobronchomalacia (TBM), a condition of excessive collapse of the airways during respiration leading to cardiopulmonary arrest.

The particular value of such 3-D–printable biomaterials to pediatric surgery is their ability to adopt a 4-D modality – to exhibit specifically engineered shape changes in response to surrounding tissue growth over a defined time period. In addition to their malleability, these devices also are designed to biodegrade. These features have proven especially useful as seen in this medical device emergency use exemption study performed at the University of Michigan, according to a report published in Science Translational Medicine (2015 Apr 29. [doi: 10.1126/scitranslmed.3010825]).

“Our multidisciplinary team designed an archetype device to allow radial expansion of the affected airway over the critical growth period while resisting external compression and intrinsic collapse,” wrote Dr. Robert J. Morrison of the University of Michigan, Ann Arbor, and his colleagues.

The study population involved three infant boys, aged 3 months, 5 months, and 16 months at time of treatment. In each patient, a sternotomy exposed their affected airways. The 3-D–printed splint, consisting of conjoined rib-like C-shaped arches was placed around the affected airway and secured with polypropylene sutures. The splint counters external pressure on the airway and holds it open. Because the splint is malleable, with an expandable opening placed opposite to the main collapsing pressure, it is capable of expanding as the airway grows.

Examination of the airway immediately after placement demonstrated patency, which was confirmed 1 month later. Results showed the benefit of the splints for all three patients, although total results were complicated by additional comorbidities:

• Patient 1: Blood gases returned to normal immediately after implantation and remained normal at 3 months’ follow-up. A week after implantation, weaning from mechanical ventilation was initiated and, 3 weeks after the procedure, the child was discharged to home. Repeat imaging at 1, 3, 6, 12, and 39 months postoperatively demonstrated continued resolution of the TBM, with evidence of fragmentation and degradation of the splint at 39 months.

• Patient 2: Immediately after implantation of the device, blood gases improved greatly and the left lung perfused. The patient had opioid and benzodiazepine dependence from long-term ventilator support, requiring a longer controlled wean from the ventilator. Four weeks after surgery, the patient was transitioned to a portable ventilator system, completely weaned at 15 weeks, and discharged from the hospital to home for the first time in his life.

• Patient 3: After implantation, the patient ceased experiencing life-threatening desaturation episodes and showed sustained improvement in blood gases. Imaging showed continued patency of the left main bronchus with resolution of left-lung air trapping. However, at 14 months post implantation, he remained on permanent ventilator support, “presumably because of distal left segmental bronchomalacia beyond what the splint was designed to address,” according to Dr. Morrison and his colleagues.

“We report successful implantation of patient-specific bioresorbable airway splints for the treatment of severe TBM. The personalized splints conformed to the patients’ individual geometries and expanded with airway growth (in the ‘fourth dimension’),” the researchers summarized.

“The three pediatric patients implanted with these 3-D–printed airway splints had a terminal form of TBM. The clinical improvement in each case was immediate and sustained, suggesting that improvement is not attributable to the natural history of the disease alone,” they concluded.

The study was funded by the National Institutes of Health. Two of the study authors were coinventors of the device for which they have filed a patent. There were no other disclosures.

[email protected]

Immediate and continued life-sustaining improvement was seen in three pediatric patients implanted with 3-D–printed tracheobronchial splints as a treatment for terminal tracheobronchomalacia (TBM), a condition of excessive collapse of the airways during respiration leading to cardiopulmonary arrest.

The particular value of such 3-D–printable biomaterials to pediatric surgery is their ability to adopt a 4-D modality – to exhibit specifically engineered shape changes in response to surrounding tissue growth over a defined time period. In addition to their malleability, these devices also are designed to biodegrade. These features have proven especially useful as seen in this medical device emergency use exemption study performed at the University of Michigan, according to a report published in Science Translational Medicine (2015 Apr 29. [doi: 10.1126/scitranslmed.3010825]).

“Our multidisciplinary team designed an archetype device to allow radial expansion of the affected airway over the critical growth period while resisting external compression and intrinsic collapse,” wrote Dr. Robert J. Morrison of the University of Michigan, Ann Arbor, and his colleagues.

The study population involved three infant boys, aged 3 months, 5 months, and 16 months at time of treatment. In each patient, a sternotomy exposed their affected airways. The 3-D–printed splint, consisting of conjoined rib-like C-shaped arches was placed around the affected airway and secured with polypropylene sutures. The splint counters external pressure on the airway and holds it open. Because the splint is malleable, with an expandable opening placed opposite to the main collapsing pressure, it is capable of expanding as the airway grows.

Examination of the airway immediately after placement demonstrated patency, which was confirmed 1 month later. Results showed the benefit of the splints for all three patients, although total results were complicated by additional comorbidities:

• Patient 1: Blood gases returned to normal immediately after implantation and remained normal at 3 months’ follow-up. A week after implantation, weaning from mechanical ventilation was initiated and, 3 weeks after the procedure, the child was discharged to home. Repeat imaging at 1, 3, 6, 12, and 39 months postoperatively demonstrated continued resolution of the TBM, with evidence of fragmentation and degradation of the splint at 39 months.

• Patient 2: Immediately after implantation of the device, blood gases improved greatly and the left lung perfused. The patient had opioid and benzodiazepine dependence from long-term ventilator support, requiring a longer controlled wean from the ventilator. Four weeks after surgery, the patient was transitioned to a portable ventilator system, completely weaned at 15 weeks, and discharged from the hospital to home for the first time in his life.

• Patient 3: After implantation, the patient ceased experiencing life-threatening desaturation episodes and showed sustained improvement in blood gases. Imaging showed continued patency of the left main bronchus with resolution of left-lung air trapping. However, at 14 months post implantation, he remained on permanent ventilator support, “presumably because of distal left segmental bronchomalacia beyond what the splint was designed to address,” according to Dr. Morrison and his colleagues.

“We report successful implantation of patient-specific bioresorbable airway splints for the treatment of severe TBM. The personalized splints conformed to the patients’ individual geometries and expanded with airway growth (in the ‘fourth dimension’),” the researchers summarized.

“The three pediatric patients implanted with these 3-D–printed airway splints had a terminal form of TBM. The clinical improvement in each case was immediate and sustained, suggesting that improvement is not attributable to the natural history of the disease alone,” they concluded.

The study was funded by the National Institutes of Health. Two of the study authors were coinventors of the device for which they have filed a patent. There were no other disclosures.

[email protected]