ACS Surgery News

SNOWMASS, COLO. – Valve-sparing root replacement has emerged as the procedure of choice in patients with isolated aortic root disease and a normally functioning aortic valve, according to Dr. Thoralf M. Sundt III.

"The valve-sparing root operations, in contrast to some of the other things we surgeons have come up with over the last decade or so, are increasing in popularity. They’re more and more commonly done, and that’s a good sign. I think the marketplace has spoken and this is clearly a good operation. It’s an operation that can be learned, and surgeons can do it with good results," he said at the Annual Cardiovascular Conference at Snowmass.

Valve-sparing root replacement (VSRR) spares a patient from the complications associated with lifelong anticoagulation for a mechanical valve, and the durability of VSRR appears to be superior to that of third-generation bioprostheses, the surgeon added.

"They’re holding up pretty well. The outcomes approach those with mechanical valves," said Dr. Sundt, chief of cardiac surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, Boston.

Moreover, he continued, VSRR has another big advantage over bioprosthetic valves: "If you have to re-operate, it’s a whole lot more fun to do so on someone who’s had a VSRR and put a new biologic valve inside a native annulus than it is to try to take out that old bioprosthesis and put a new bioprosthesis in."

A meta-analysis of 11 studies comparing VSRR with total root replacement in patients with Marfan syndrome concluded that composite valve-related event rates for the two surgical strategies were not significantly different. The thromboembolic event rate was 0.3% per year in VSRR-treated patients, significantly lower than the still-quite-reasonable 0.7% per year rate after total root replacement (Heart 2011;97:955-8).

A recent study by surgeons at Stanford (Calif.) University gave VSRR a thumbs up regarding mid-term durability of outcomes through 6 years of follow-up, with a mean 2.9-year and maximum 6-year follow-up. The series included 75 patients with bicuspid aortic valve disease treated by VSRR.

Six-year actuarial survival was 99%, with 90% freedom from reoperation and no strokes. Thirty-one percent of patients had 2+ aortic regurgitation preoperatively; at echocardiographic follow-up a mean of 2.9 years post surgery, only a couple of patients had 2+ aortic regurgitation and no one was more severely affected. The Stanford investigators plan to update their results when follow-up reaches 10 years or more (J. Thorac. Cardiovasc. Surg. Dec. 20, 2012 [doi:10.1016/j.jtcvs.2012.11.043]).

The VSRR was developed by Dr. Tirone David of the University of Toronto. The procedure involves skeletonizing the root while preserving the leaflets and their attachments to the aortic wall. The aortic valve is then reimplanted inside a tubular Dacron graft, and then the coronary arteries are reimplanted.

"It’s probably the neatest development in terms of surgical options for the aortic valve in a long time," Dr. Sundt said.

He reported having no financial conflicts.

[email protected]

SNOWMASS, COLO. – Valve-sparing root replacement has emerged as the procedure of choice in patients with isolated aortic root disease and a normally functioning aortic valve, according to Dr. Thoralf M. Sundt III.

"The valve-sparing root operations, in contrast to some of the other things we surgeons have come up with over the last decade or so, are increasing in popularity. They’re more and more commonly done, and that’s a good sign. I think the marketplace has spoken and this is clearly a good operation. It’s an operation that can be learned, and surgeons can do it with good results," he said at the Annual Cardiovascular Conference at Snowmass.

Valve-sparing root replacement (VSRR) spares a patient from the complications associated with lifelong anticoagulation for a mechanical valve, and the durability of VSRR appears to be superior to that of third-generation bioprostheses, the surgeon added.

"They’re holding up pretty well. The outcomes approach those with mechanical valves," said Dr. Sundt, chief of cardiac surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, Boston.

Moreover, he continued, VSRR has another big advantage over bioprosthetic valves: "If you have to re-operate, it’s a whole lot more fun to do so on someone who’s had a VSRR and put a new biologic valve inside a native annulus than it is to try to take out that old bioprosthesis and put a new bioprosthesis in."

A meta-analysis of 11 studies comparing VSRR with total root replacement in patients with Marfan syndrome concluded that composite valve-related event rates for the two surgical strategies were not significantly different. The thromboembolic event rate was 0.3% per year in VSRR-treated patients, significantly lower than the still-quite-reasonable 0.7% per year rate after total root replacement (Heart 2011;97:955-8).

A recent study by surgeons at Stanford (Calif.) University gave VSRR a thumbs up regarding mid-term durability of outcomes through 6 years of follow-up, with a mean 2.9-year and maximum 6-year follow-up. The series included 75 patients with bicuspid aortic valve disease treated by VSRR.

Six-year actuarial survival was 99%, with 90% freedom from reoperation and no strokes. Thirty-one percent of patients had 2+ aortic regurgitation preoperatively; at echocardiographic follow-up a mean of 2.9 years post surgery, only a couple of patients had 2+ aortic regurgitation and no one was more severely affected. The Stanford investigators plan to update their results when follow-up reaches 10 years or more (J. Thorac. Cardiovasc. Surg. Dec. 20, 2012 [doi:10.1016/j.jtcvs.2012.11.043]).

The VSRR was developed by Dr. Tirone David of the University of Toronto. The procedure involves skeletonizing the root while preserving the leaflets and their attachments to the aortic wall. The aortic valve is then reimplanted inside a tubular Dacron graft, and then the coronary arteries are reimplanted.

"It’s probably the neatest development in terms of surgical options for the aortic valve in a long time," Dr. Sundt said.

He reported having no financial conflicts.

[email protected]

SNOWMASS, COLO. – Valve-sparing root replacement has emerged as the procedure of choice in patients with isolated aortic root disease and a normally functioning aortic valve, according to Dr. Thoralf M. Sundt III.

"The valve-sparing root operations, in contrast to some of the other things we surgeons have come up with over the last decade or so, are increasing in popularity. They’re more and more commonly done, and that’s a good sign. I think the marketplace has spoken and this is clearly a good operation. It’s an operation that can be learned, and surgeons can do it with good results," he said at the Annual Cardiovascular Conference at Snowmass.

Valve-sparing root replacement (VSRR) spares a patient from the complications associated with lifelong anticoagulation for a mechanical valve, and the durability of VSRR appears to be superior to that of third-generation bioprostheses, the surgeon added.

"They’re holding up pretty well. The outcomes approach those with mechanical valves," said Dr. Sundt, chief of cardiac surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, Boston.

Moreover, he continued, VSRR has another big advantage over bioprosthetic valves: "If you have to re-operate, it’s a whole lot more fun to do so on someone who’s had a VSRR and put a new biologic valve inside a native annulus than it is to try to take out that old bioprosthesis and put a new bioprosthesis in."

A meta-analysis of 11 studies comparing VSRR with total root replacement in patients with Marfan syndrome concluded that composite valve-related event rates for the two surgical strategies were not significantly different. The thromboembolic event rate was 0.3% per year in VSRR-treated patients, significantly lower than the still-quite-reasonable 0.7% per year rate after total root replacement (Heart 2011;97:955-8).

A recent study by surgeons at Stanford (Calif.) University gave VSRR a thumbs up regarding mid-term durability of outcomes through 6 years of follow-up, with a mean 2.9-year and maximum 6-year follow-up. The series included 75 patients with bicuspid aortic valve disease treated by VSRR.

Six-year actuarial survival was 99%, with 90% freedom from reoperation and no strokes. Thirty-one percent of patients had 2+ aortic regurgitation preoperatively; at echocardiographic follow-up a mean of 2.9 years post surgery, only a couple of patients had 2+ aortic regurgitation and no one was more severely affected. The Stanford investigators plan to update their results when follow-up reaches 10 years or more (J. Thorac. Cardiovasc. Surg. Dec. 20, 2012 [doi:10.1016/j.jtcvs.2012.11.043]).

The VSRR was developed by Dr. Tirone David of the University of Toronto. The procedure involves skeletonizing the root while preserving the leaflets and their attachments to the aortic wall. The aortic valve is then reimplanted inside a tubular Dacron graft, and then the coronary arteries are reimplanted.

"It’s probably the neatest development in terms of surgical options for the aortic valve in a long time," Dr. Sundt said.

He reported having no financial conflicts.

[email protected]

Hydroxyethyl starch, a synthetic colloid used worldwide for acute fluid resuscitation in critically ill patients, appears to significantly raise the risks of mortality and severe renal injury, compared with other resuscitation solutions, according to a systematic review and meta-analysis published in the Feb. 20 issue of JAMA.

The use of hydroxyethyl starch and other colloidal starch solutions has increased "despite their higher cost relative to crystalloid solutions, lack of evidence of their clinical superiority, and pervasive safety concerns," said Dr. Ryan Zarychanski of the section of critical care and the section of hematology and medical oncology, University of Manitoba, Winnipeg, and his associates (JAMA 2013;309:678-88).

Nonetheless, "over the years, hydroxyethyl starch products have appeared in several resuscitation guidelines, including those of the U.S. Hospital Consortium, and have often been advocated as the cornerstone of resuscitation therapy," the researchers noted.

Many of the data supporting the use of hydroxyethyl starch were recently retracted from the literature, however, after an investigation found that leading scientist Dr. Joachim Boldt had used unethical research practices and had fabricated data in at least 88 studies.

"All major systematic reviews and clinical guidelines are now being revised to account for the retracted data and permit sensitivity analyses on the remaining publications by Boldt et al.," Dr. Zarychanski and his colleagues said.

They performed a rigorous systematic review of randomized controlled trials comparing hydroxyethyl starch against crystalloid, albumin, or gelatin IV fluids for acute fluid resuscitation in critically ill adults. The study subjects were treated in emergency or intensive care settings during 1982-2012.

The meta-analysis covered 38 trials, including 7 studies by Dr. Boldt that had not been retracted because they had been published before 1999, the cutoff date for the misconduct investigation.

A total of 35 studies involving 10,880 patients contributed mortality data to the meta-analysis. The overall mortality risk was significantly higher for patients randomly assigned to receive hydroxyethyl starch than for those assigned to other solutions (relative risk, 1.07).

When the data from the seven Dr. Boldt studies were excluded from the meta-analysis, the pooled results from the remaining 28 trials (10,290 patients) showed an even stronger increase in mortality risk (RR, 1.09).

The seven Boldt trials were then excluded from all further analyses.

Ten trials reported on the rate of renal replacement therapy in 9,258 patients. The use of hydroxyethyl starch was associated with a significantly greater risk of renal injury (RR, 1.32), compared with other resuscitation fluids.

The incidence of acute renal failure was reported in five trials involving 8,725 patients. Again, the incidence of this adverse effect was significantly greater in patients randomly assigned to receive hydroxyethyl starch than in those receiving other fluids (RR, 1.27).

Several sensitivity and subgroup analyses all supported the findings from the main analysis. The results indicate that "clinical use of hydroxyethyl starch for acute volume resuscitation is not warranted due to serious safety concerns," Dr. Zarychanski and his associates said.

Although hydroxyethyl starch solutions are effective volume expanders, their effects are not confined to the circulatory system, the investigators explained. The solutions also are deposited in the endothelial cells, kidneys, liver, muscle, skin, and spleen.

"Proponents of starch solutions have argued increased safety with each newly marketed product, but evidence from randomized trials [does] not support these claims," the study authors said.

In addition, their meta-analysis demonstrated that the publication of inaccurate or fraudulent data "can influence how the global medical community interprets a given body of literature, and how exclusion of questionable studies can shift the balance of evidence toward benefit or harm."

Dr. Zarychanski reported no relevant financial disclosures; an associate reported ties to Bristol-Myers Squibb and Abbott Laboratories.

[email protected]

Hydroxyethyl starch, a synthetic colloid used worldwide for acute fluid resuscitation in critically ill patients, appears to significantly raise the risks of mortality and severe renal injury, compared with other resuscitation solutions, according to a systematic review and meta-analysis published in the Feb. 20 issue of JAMA.

The use of hydroxyethyl starch and other colloidal starch solutions has increased "despite their higher cost relative to crystalloid solutions, lack of evidence of their clinical superiority, and pervasive safety concerns," said Dr. Ryan Zarychanski of the section of critical care and the section of hematology and medical oncology, University of Manitoba, Winnipeg, and his associates (JAMA 2013;309:678-88).

Nonetheless, "over the years, hydroxyethyl starch products have appeared in several resuscitation guidelines, including those of the U.S. Hospital Consortium, and have often been advocated as the cornerstone of resuscitation therapy," the researchers noted.

Many of the data supporting the use of hydroxyethyl starch were recently retracted from the literature, however, after an investigation found that leading scientist Dr. Joachim Boldt had used unethical research practices and had fabricated data in at least 88 studies.

"All major systematic reviews and clinical guidelines are now being revised to account for the retracted data and permit sensitivity analyses on the remaining publications by Boldt et al.," Dr. Zarychanski and his colleagues said.

They performed a rigorous systematic review of randomized controlled trials comparing hydroxyethyl starch against crystalloid, albumin, or gelatin IV fluids for acute fluid resuscitation in critically ill adults. The study subjects were treated in emergency or intensive care settings during 1982-2012.

The meta-analysis covered 38 trials, including 7 studies by Dr. Boldt that had not been retracted because they had been published before 1999, the cutoff date for the misconduct investigation.

A total of 35 studies involving 10,880 patients contributed mortality data to the meta-analysis. The overall mortality risk was significantly higher for patients randomly assigned to receive hydroxyethyl starch than for those assigned to other solutions (relative risk, 1.07).

When the data from the seven Dr. Boldt studies were excluded from the meta-analysis, the pooled results from the remaining 28 trials (10,290 patients) showed an even stronger increase in mortality risk (RR, 1.09).

The seven Boldt trials were then excluded from all further analyses.

Ten trials reported on the rate of renal replacement therapy in 9,258 patients. The use of hydroxyethyl starch was associated with a significantly greater risk of renal injury (RR, 1.32), compared with other resuscitation fluids.

The incidence of acute renal failure was reported in five trials involving 8,725 patients. Again, the incidence of this adverse effect was significantly greater in patients randomly assigned to receive hydroxyethyl starch than in those receiving other fluids (RR, 1.27).

Several sensitivity and subgroup analyses all supported the findings from the main analysis. The results indicate that "clinical use of hydroxyethyl starch for acute volume resuscitation is not warranted due to serious safety concerns," Dr. Zarychanski and his associates said.

Although hydroxyethyl starch solutions are effective volume expanders, their effects are not confined to the circulatory system, the investigators explained. The solutions also are deposited in the endothelial cells, kidneys, liver, muscle, skin, and spleen.

"Proponents of starch solutions have argued increased safety with each newly marketed product, but evidence from randomized trials [does] not support these claims," the study authors said.

In addition, their meta-analysis demonstrated that the publication of inaccurate or fraudulent data "can influence how the global medical community interprets a given body of literature, and how exclusion of questionable studies can shift the balance of evidence toward benefit or harm."

Dr. Zarychanski reported no relevant financial disclosures; an associate reported ties to Bristol-Myers Squibb and Abbott Laboratories.

[email protected]

Hydroxyethyl starch, a synthetic colloid used worldwide for acute fluid resuscitation in critically ill patients, appears to significantly raise the risks of mortality and severe renal injury, compared with other resuscitation solutions, according to a systematic review and meta-analysis published in the Feb. 20 issue of JAMA.

The use of hydroxyethyl starch and other colloidal starch solutions has increased "despite their higher cost relative to crystalloid solutions, lack of evidence of their clinical superiority, and pervasive safety concerns," said Dr. Ryan Zarychanski of the section of critical care and the section of hematology and medical oncology, University of Manitoba, Winnipeg, and his associates (JAMA 2013;309:678-88).

Nonetheless, "over the years, hydroxyethyl starch products have appeared in several resuscitation guidelines, including those of the U.S. Hospital Consortium, and have often been advocated as the cornerstone of resuscitation therapy," the researchers noted.

Many of the data supporting the use of hydroxyethyl starch were recently retracted from the literature, however, after an investigation found that leading scientist Dr. Joachim Boldt had used unethical research practices and had fabricated data in at least 88 studies.

"All major systematic reviews and clinical guidelines are now being revised to account for the retracted data and permit sensitivity analyses on the remaining publications by Boldt et al.," Dr. Zarychanski and his colleagues said.

They performed a rigorous systematic review of randomized controlled trials comparing hydroxyethyl starch against crystalloid, albumin, or gelatin IV fluids for acute fluid resuscitation in critically ill adults. The study subjects were treated in emergency or intensive care settings during 1982-2012.

The meta-analysis covered 38 trials, including 7 studies by Dr. Boldt that had not been retracted because they had been published before 1999, the cutoff date for the misconduct investigation.

A total of 35 studies involving 10,880 patients contributed mortality data to the meta-analysis. The overall mortality risk was significantly higher for patients randomly assigned to receive hydroxyethyl starch than for those assigned to other solutions (relative risk, 1.07).

When the data from the seven Dr. Boldt studies were excluded from the meta-analysis, the pooled results from the remaining 28 trials (10,290 patients) showed an even stronger increase in mortality risk (RR, 1.09).

The seven Boldt trials were then excluded from all further analyses.

Ten trials reported on the rate of renal replacement therapy in 9,258 patients. The use of hydroxyethyl starch was associated with a significantly greater risk of renal injury (RR, 1.32), compared with other resuscitation fluids.

The incidence of acute renal failure was reported in five trials involving 8,725 patients. Again, the incidence of this adverse effect was significantly greater in patients randomly assigned to receive hydroxyethyl starch than in those receiving other fluids (RR, 1.27).

Several sensitivity and subgroup analyses all supported the findings from the main analysis. The results indicate that "clinical use of hydroxyethyl starch for acute volume resuscitation is not warranted due to serious safety concerns," Dr. Zarychanski and his associates said.

Although hydroxyethyl starch solutions are effective volume expanders, their effects are not confined to the circulatory system, the investigators explained. The solutions also are deposited in the endothelial cells, kidneys, liver, muscle, skin, and spleen.

"Proponents of starch solutions have argued increased safety with each newly marketed product, but evidence from randomized trials [does] not support these claims," the study authors said.

In addition, their meta-analysis demonstrated that the publication of inaccurate or fraudulent data "can influence how the global medical community interprets a given body of literature, and how exclusion of questionable studies can shift the balance of evidence toward benefit or harm."

Dr. Zarychanski reported no relevant financial disclosures; an associate reported ties to Bristol-Myers Squibb and Abbott Laboratories.

[email protected]

Two heart societies, a device maker, and two federal agencies have collaborated to develop a trial for transcatheter aortic valve replacement, once again extending the concept of teamwork, which is the cornerstone of this technology, far beyond the operating room walls.

During the past year, the Society of Thoracic Surgeons and the American College of Cardiology worked with the Food and Drug Administration, the Centers for Medicare and Medicaid Services (CMS), and Edwards Lifesciences to develop a trial that assesses the safety and efficacy of nontransfemoral approaches for TAVR, using the already-approved Edwards SAPIEN valves.

Copyright ACC

"What makes it unusual is, to the best of our knowledge, this is the first investigational device exemption [IDE] granted by the FDA to medical societies who operate national clinical registries," said ACC President Dr. William Zoghbi.

The societies will run the trial with funding from Edwards, and Medicare will pay for the procedures.

"This allows physicians to get reimbursed for off-label use," said Dr. Michael J. Mack, past president of STS and chair of the STS/ACC TVT (Transcatheter Valvular Therapy) Registry Steering Committee. "And it also allows for controlled off-label use, in which the outcomes can be captured and the sites can be paid while this information is being captured. People should be excited about it."

The goal of the trial is to expand the field and to extend TAVR to a broader group of patients, the societies said.

"A similar mechanism has been used in the past for the implantation of ICDs [implantable cardioverter-defibrillators] for patients who met particular criteria and get the funding as the registry moves forward," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who is not involved in the trial or registry.

But currently, "the ICD Registry is not conducting an IDE to evaluate and reimburse for other possible indications of ICDs," said Dr. Zoghbi.

In the United States, an estimated one in four inoperable patients with severe aortic stenosis is not eligible for TAVR through a transfemoral or transapical approach because of vessel size, vessel disease, or other anatomical restrictions, according to the societies. Alternative routes, such as the transaortic approach, could provide an option for them.

STS and ACC are also working to get FDA approval for two more studies.

"The collaboration and use of registries for research in this pilot can be a model for specialty societies, industry, and federal regulators," Dr. Zoghbi said in a statement. "We have aligned our efforts to ensure patient access to a new technology in a safe and cost-effective way."

The study also stands out in the list of TAVR clinical trials approved by CMS, which began covering TAVR in May 2012: The other five are sponsored by Edwards or Medtronic.

The earlier collaboration of the entities that have developed this trial resulted in the STS/ACC TVT Registry, which captures TAVR-related patient demographics, procedure details, and facility and physician information.

The observational study is conducted in the TVT Registry, and will follow 1,000 patients. Any of the nearly 180 sites using the TVT Registry can participate in the study.

The trial will gather 30-day safety endpoints for patients who undergo alternative access approaches such as transapical and transaortic routes. The lumped data will then be compared with the 30-day outcomes of the transapical approach reported in Cohort A of the PARTNER trial.

Because the trial is covered by Medicare, it has to adhere to conditions set by the agency. The requirements will ensure better patient care, Dr. Jeffrey B. Rich, the STS immediate past president, said in a statement, because the "preoperative evaluation, interoperative deployment of the valve, and postoperative care must be jointly shared by cardiologists and cardiothoracic surgeons, utilizing the heart team approach."

Alternative access approaches in the trial include the left ventricular apex (transapical), ascending aorta, subclavian and axillary arteries, and distal aorta, as well as retroperitoneal access to the iliac artery.

The approaches have several advantages, according to the societies. For one, the risks associated with inserting large-caliber catheters into small, diseased femoral arteries are reduced. Also, nonfemoral access sites can provide for better catheter control and safer closure of the access site.

But since some of the alternative approaches, such as the transaortic approach, have not been approved, the operator training lags behind the already-approved transfemoral and transapical approaches. To address this, the societies and Edwards will probably have to create a contract to train the surgeons and cardiologists for the specific purpose of this trial, said Dr. Mack.

The alternative approaches also require additional equipment, and operators may be exposed to greater amounts of radiation. They may also lead to longer recovery and more incisional pain for patients, according to the societies.

Dr. Mack said that the trial will likely be completed in 6 months or less from its start date.

"Using registries for this kind of study has the potential to make new technology available in a timely manner while protecting patient safety," ACC Immediate Past President Dr. David Holmes said in a statement.

None of the physicians had relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

Two heart societies, a device maker, and two federal agencies have collaborated to develop a trial for transcatheter aortic valve replacement, once again extending the concept of teamwork, which is the cornerstone of this technology, far beyond the operating room walls.

During the past year, the Society of Thoracic Surgeons and the American College of Cardiology worked with the Food and Drug Administration, the Centers for Medicare and Medicaid Services (CMS), and Edwards Lifesciences to develop a trial that assesses the safety and efficacy of nontransfemoral approaches for TAVR, using the already-approved Edwards SAPIEN valves.

Copyright ACC

"What makes it unusual is, to the best of our knowledge, this is the first investigational device exemption [IDE] granted by the FDA to medical societies who operate national clinical registries," said ACC President Dr. William Zoghbi.

The societies will run the trial with funding from Edwards, and Medicare will pay for the procedures.

"This allows physicians to get reimbursed for off-label use," said Dr. Michael J. Mack, past president of STS and chair of the STS/ACC TVT (Transcatheter Valvular Therapy) Registry Steering Committee. "And it also allows for controlled off-label use, in which the outcomes can be captured and the sites can be paid while this information is being captured. People should be excited about it."

The goal of the trial is to expand the field and to extend TAVR to a broader group of patients, the societies said.

"A similar mechanism has been used in the past for the implantation of ICDs [implantable cardioverter-defibrillators] for patients who met particular criteria and get the funding as the registry moves forward," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who is not involved in the trial or registry.

But currently, "the ICD Registry is not conducting an IDE to evaluate and reimburse for other possible indications of ICDs," said Dr. Zoghbi.

In the United States, an estimated one in four inoperable patients with severe aortic stenosis is not eligible for TAVR through a transfemoral or transapical approach because of vessel size, vessel disease, or other anatomical restrictions, according to the societies. Alternative routes, such as the transaortic approach, could provide an option for them.

STS and ACC are also working to get FDA approval for two more studies.

"The collaboration and use of registries for research in this pilot can be a model for specialty societies, industry, and federal regulators," Dr. Zoghbi said in a statement. "We have aligned our efforts to ensure patient access to a new technology in a safe and cost-effective way."

The study also stands out in the list of TAVR clinical trials approved by CMS, which began covering TAVR in May 2012: The other five are sponsored by Edwards or Medtronic.

The earlier collaboration of the entities that have developed this trial resulted in the STS/ACC TVT Registry, which captures TAVR-related patient demographics, procedure details, and facility and physician information.

The observational study is conducted in the TVT Registry, and will follow 1,000 patients. Any of the nearly 180 sites using the TVT Registry can participate in the study.

The trial will gather 30-day safety endpoints for patients who undergo alternative access approaches such as transapical and transaortic routes. The lumped data will then be compared with the 30-day outcomes of the transapical approach reported in Cohort A of the PARTNER trial.

Because the trial is covered by Medicare, it has to adhere to conditions set by the agency. The requirements will ensure better patient care, Dr. Jeffrey B. Rich, the STS immediate past president, said in a statement, because the "preoperative evaluation, interoperative deployment of the valve, and postoperative care must be jointly shared by cardiologists and cardiothoracic surgeons, utilizing the heart team approach."

Alternative access approaches in the trial include the left ventricular apex (transapical), ascending aorta, subclavian and axillary arteries, and distal aorta, as well as retroperitoneal access to the iliac artery.

The approaches have several advantages, according to the societies. For one, the risks associated with inserting large-caliber catheters into small, diseased femoral arteries are reduced. Also, nonfemoral access sites can provide for better catheter control and safer closure of the access site.

But since some of the alternative approaches, such as the transaortic approach, have not been approved, the operator training lags behind the already-approved transfemoral and transapical approaches. To address this, the societies and Edwards will probably have to create a contract to train the surgeons and cardiologists for the specific purpose of this trial, said Dr. Mack.

The alternative approaches also require additional equipment, and operators may be exposed to greater amounts of radiation. They may also lead to longer recovery and more incisional pain for patients, according to the societies.

Dr. Mack said that the trial will likely be completed in 6 months or less from its start date.

"Using registries for this kind of study has the potential to make new technology available in a timely manner while protecting patient safety," ACC Immediate Past President Dr. David Holmes said in a statement.

None of the physicians had relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

Two heart societies, a device maker, and two federal agencies have collaborated to develop a trial for transcatheter aortic valve replacement, once again extending the concept of teamwork, which is the cornerstone of this technology, far beyond the operating room walls.

During the past year, the Society of Thoracic Surgeons and the American College of Cardiology worked with the Food and Drug Administration, the Centers for Medicare and Medicaid Services (CMS), and Edwards Lifesciences to develop a trial that assesses the safety and efficacy of nontransfemoral approaches for TAVR, using the already-approved Edwards SAPIEN valves.

Copyright ACC

"What makes it unusual is, to the best of our knowledge, this is the first investigational device exemption [IDE] granted by the FDA to medical societies who operate national clinical registries," said ACC President Dr. William Zoghbi.

The societies will run the trial with funding from Edwards, and Medicare will pay for the procedures.

"This allows physicians to get reimbursed for off-label use," said Dr. Michael J. Mack, past president of STS and chair of the STS/ACC TVT (Transcatheter Valvular Therapy) Registry Steering Committee. "And it also allows for controlled off-label use, in which the outcomes can be captured and the sites can be paid while this information is being captured. People should be excited about it."

The goal of the trial is to expand the field and to extend TAVR to a broader group of patients, the societies said.

"A similar mechanism has been used in the past for the implantation of ICDs [implantable cardioverter-defibrillators] for patients who met particular criteria and get the funding as the registry moves forward," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who is not involved in the trial or registry.

But currently, "the ICD Registry is not conducting an IDE to evaluate and reimburse for other possible indications of ICDs," said Dr. Zoghbi.

In the United States, an estimated one in four inoperable patients with severe aortic stenosis is not eligible for TAVR through a transfemoral or transapical approach because of vessel size, vessel disease, or other anatomical restrictions, according to the societies. Alternative routes, such as the transaortic approach, could provide an option for them.

STS and ACC are also working to get FDA approval for two more studies.

"The collaboration and use of registries for research in this pilot can be a model for specialty societies, industry, and federal regulators," Dr. Zoghbi said in a statement. "We have aligned our efforts to ensure patient access to a new technology in a safe and cost-effective way."

The study also stands out in the list of TAVR clinical trials approved by CMS, which began covering TAVR in May 2012: The other five are sponsored by Edwards or Medtronic.

The earlier collaboration of the entities that have developed this trial resulted in the STS/ACC TVT Registry, which captures TAVR-related patient demographics, procedure details, and facility and physician information.

The observational study is conducted in the TVT Registry, and will follow 1,000 patients. Any of the nearly 180 sites using the TVT Registry can participate in the study.

The trial will gather 30-day safety endpoints for patients who undergo alternative access approaches such as transapical and transaortic routes. The lumped data will then be compared with the 30-day outcomes of the transapical approach reported in Cohort A of the PARTNER trial.

Because the trial is covered by Medicare, it has to adhere to conditions set by the agency. The requirements will ensure better patient care, Dr. Jeffrey B. Rich, the STS immediate past president, said in a statement, because the "preoperative evaluation, interoperative deployment of the valve, and postoperative care must be jointly shared by cardiologists and cardiothoracic surgeons, utilizing the heart team approach."

Alternative access approaches in the trial include the left ventricular apex (transapical), ascending aorta, subclavian and axillary arteries, and distal aorta, as well as retroperitoneal access to the iliac artery.

The approaches have several advantages, according to the societies. For one, the risks associated with inserting large-caliber catheters into small, diseased femoral arteries are reduced. Also, nonfemoral access sites can provide for better catheter control and safer closure of the access site.

But since some of the alternative approaches, such as the transaortic approach, have not been approved, the operator training lags behind the already-approved transfemoral and transapical approaches. To address this, the societies and Edwards will probably have to create a contract to train the surgeons and cardiologists for the specific purpose of this trial, said Dr. Mack.

The alternative approaches also require additional equipment, and operators may be exposed to greater amounts of radiation. They may also lead to longer recovery and more incisional pain for patients, according to the societies.

Dr. Mack said that the trial will likely be completed in 6 months or less from its start date.

"Using registries for this kind of study has the potential to make new technology available in a timely manner while protecting patient safety," ACC Immediate Past President Dr. David Holmes said in a statement.

None of the physicians had relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

Members of Congress are getting down to work early this year on a plan to avert the 27% Medicare pay cut that will hit physicians on Jan. 1, 2014. And they are even talking about a permanent replacement for the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

Alicia Ault/IMNG Medical Media

One of the reasons this year’s repeal attempt could be different is that the price is actually going down. A new estimate from the Congressional Budget Office (CBO) puts the 10-year cost for freezing physician payments at current levels at $138 billion. That’s a hefty price tag, but it’s about $100 billion lower than previous estimates because of lower spending on physician services, according to the CBO.

Congress is also continuing to debate the fate of the Independent Payment Advisory Board (IPAB). The 15-member panel, which has yet to be appointed, would recommend cuts to Medicare provider payments. Now bills have been dropped in both the House and Senate to strip the IPAB provision from the Affordable Care Act.

Check out this week’s Policy & Practice Podcast for more on the SGR, the IPAB, the State of the Union address, and progress on implementing state health insurance exchanges.

–Mary Ellen Schneider

[email protected]

Members of Congress are getting down to work early this year on a plan to avert the 27% Medicare pay cut that will hit physicians on Jan. 1, 2014. And they are even talking about a permanent replacement for the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

Alicia Ault/IMNG Medical Media

One of the reasons this year’s repeal attempt could be different is that the price is actually going down. A new estimate from the Congressional Budget Office (CBO) puts the 10-year cost for freezing physician payments at current levels at $138 billion. That’s a hefty price tag, but it’s about $100 billion lower than previous estimates because of lower spending on physician services, according to the CBO.

Congress is also continuing to debate the fate of the Independent Payment Advisory Board (IPAB). The 15-member panel, which has yet to be appointed, would recommend cuts to Medicare provider payments. Now bills have been dropped in both the House and Senate to strip the IPAB provision from the Affordable Care Act.

Check out this week’s Policy & Practice Podcast for more on the SGR, the IPAB, the State of the Union address, and progress on implementing state health insurance exchanges.

–Mary Ellen Schneider

[email protected]

Members of Congress are getting down to work early this year on a plan to avert the 27% Medicare pay cut that will hit physicians on Jan. 1, 2014. And they are even talking about a permanent replacement for the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

Alicia Ault/IMNG Medical Media

One of the reasons this year’s repeal attempt could be different is that the price is actually going down. A new estimate from the Congressional Budget Office (CBO) puts the 10-year cost for freezing physician payments at current levels at $138 billion. That’s a hefty price tag, but it’s about $100 billion lower than previous estimates because of lower spending on physician services, according to the CBO.

Congress is also continuing to debate the fate of the Independent Payment Advisory Board (IPAB). The 15-member panel, which has yet to be appointed, would recommend cuts to Medicare provider payments. Now bills have been dropped in both the House and Senate to strip the IPAB provision from the Affordable Care Act.

Check out this week’s Policy & Practice Podcast for more on the SGR, the IPAB, the State of the Union address, and progress on implementing state health insurance exchanges.

–Mary Ellen Schneider

[email protected]

Older patients with small kidney tumors are up to 70% less likely to die from any cause when managed by watchful waiting rather than by surgery, based on findings from a large retrospective study.

Surveillance appears to be safe for these small lesions, with a kidney cancer mortality of just 3% over a 5-year period. In addition, watchful waiting seems to confer a cardiovascular benefit; these patients had a 49% lower cardiac mortality risk compared with that for patients who had kidney surgery, said lead author Dr. William C. Huang of New York University Medical Center.

The link between kidney surgery and heart problems is probably mediated by compromised kidney function, Dr. Huang said. "It’s believed that when surgery takes excess normal kidney tissue, it hastens the acceleration of kidney failure," leading to cardiovascular problems, he said.

The study findings are going to be increasingly valuable as imaging turns up more and more incidental asymptomatic kidney tumors. Last year alone, about 65,000 of these lesions were diagnosed, most of them during a work-up for other abdominal complaints.

While the trend toward surveillance of small asymptomatic lesions is growing, Dr. Huang said surgery is still the treatment mode for more than half of cases. Most procedures in the retrospective study were radical nephrectomies, with kidney removal in about half of those. "The majority of these small lesions could be removed laparoscopically, but even then you’re taking out normal kidney tissue that you might really want back someday," he said at a press briefing at the Genitourinary Cancers Symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

"Physicians can comfortably tell an elderly patient, especially a patient who is not healthy enough to tolerate general anesthesia and surgery, that the likelihood of dying of kidney cancer is low and that kidney surgery is unlikely to extend their lives," he said. "However, since it is difficult to identify which tumors will become lethal, elderly patients who are completely healthy and have an extended life expectancy, may opt for surgery."

The study examined mortality data in the Surveillance, Epidemiology, and End Results database for 8,317 patients, aged 66 years or older, who were diagnosed from 2002 to 2007 with kidney tumors smaller than 1.5 cm. The patients were followed for a median of 59 months; 78% were managed with surgery and 22%, with surveillance. The use of surveillance increased over the course of the study, from about 25% in 2002 to almost 40% in 2007.

Over the study period, 2,078 (25%) of the patients died, including 277 (3%) who died of kidney cancer. At least one cardiovascular event occurred in 24% of the patients.

Kidney cancer mortality rates did not vary between the treatment groups. However, surgical patients had a significantly increased risk of death from any cause. At 7-36 months, those who had surveillance were 30% less likely to have died than those managed by surgery (hazard ratio, 0.70). After 36 months, patients were 63% less likely to have died if their tumors were managed by surveillance instead of surgery (HR, 0.37).

Dr. Huang also demonstrated that those in the surveillance group experienced a significant cardiovascular benefit as well. By the end of the study, 25% of the deaths were due to a cardiovascular event. Patients in the surveillance group had a 49% reduction in the chance of an event.

Dr. Huang said he had no relevant financial disclosures.

[email protected]

Older patients with small kidney tumors are up to 70% less likely to die from any cause when managed by watchful waiting rather than by surgery, based on findings from a large retrospective study.

Surveillance appears to be safe for these small lesions, with a kidney cancer mortality of just 3% over a 5-year period. In addition, watchful waiting seems to confer a cardiovascular benefit; these patients had a 49% lower cardiac mortality risk compared with that for patients who had kidney surgery, said lead author Dr. William C. Huang of New York University Medical Center.

The link between kidney surgery and heart problems is probably mediated by compromised kidney function, Dr. Huang said. "It’s believed that when surgery takes excess normal kidney tissue, it hastens the acceleration of kidney failure," leading to cardiovascular problems, he said.

The study findings are going to be increasingly valuable as imaging turns up more and more incidental asymptomatic kidney tumors. Last year alone, about 65,000 of these lesions were diagnosed, most of them during a work-up for other abdominal complaints.

While the trend toward surveillance of small asymptomatic lesions is growing, Dr. Huang said surgery is still the treatment mode for more than half of cases. Most procedures in the retrospective study were radical nephrectomies, with kidney removal in about half of those. "The majority of these small lesions could be removed laparoscopically, but even then you’re taking out normal kidney tissue that you might really want back someday," he said at a press briefing at the Genitourinary Cancers Symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

"Physicians can comfortably tell an elderly patient, especially a patient who is not healthy enough to tolerate general anesthesia and surgery, that the likelihood of dying of kidney cancer is low and that kidney surgery is unlikely to extend their lives," he said. "However, since it is difficult to identify which tumors will become lethal, elderly patients who are completely healthy and have an extended life expectancy, may opt for surgery."

The study examined mortality data in the Surveillance, Epidemiology, and End Results database for 8,317 patients, aged 66 years or older, who were diagnosed from 2002 to 2007 with kidney tumors smaller than 1.5 cm. The patients were followed for a median of 59 months; 78% were managed with surgery and 22%, with surveillance. The use of surveillance increased over the course of the study, from about 25% in 2002 to almost 40% in 2007.

Over the study period, 2,078 (25%) of the patients died, including 277 (3%) who died of kidney cancer. At least one cardiovascular event occurred in 24% of the patients.

Kidney cancer mortality rates did not vary between the treatment groups. However, surgical patients had a significantly increased risk of death from any cause. At 7-36 months, those who had surveillance were 30% less likely to have died than those managed by surgery (hazard ratio, 0.70). After 36 months, patients were 63% less likely to have died if their tumors were managed by surveillance instead of surgery (HR, 0.37).

Dr. Huang also demonstrated that those in the surveillance group experienced a significant cardiovascular benefit as well. By the end of the study, 25% of the deaths were due to a cardiovascular event. Patients in the surveillance group had a 49% reduction in the chance of an event.

Dr. Huang said he had no relevant financial disclosures.

[email protected]

Older patients with small kidney tumors are up to 70% less likely to die from any cause when managed by watchful waiting rather than by surgery, based on findings from a large retrospective study.

Surveillance appears to be safe for these small lesions, with a kidney cancer mortality of just 3% over a 5-year period. In addition, watchful waiting seems to confer a cardiovascular benefit; these patients had a 49% lower cardiac mortality risk compared with that for patients who had kidney surgery, said lead author Dr. William C. Huang of New York University Medical Center.

The link between kidney surgery and heart problems is probably mediated by compromised kidney function, Dr. Huang said. "It’s believed that when surgery takes excess normal kidney tissue, it hastens the acceleration of kidney failure," leading to cardiovascular problems, he said.

The study findings are going to be increasingly valuable as imaging turns up more and more incidental asymptomatic kidney tumors. Last year alone, about 65,000 of these lesions were diagnosed, most of them during a work-up for other abdominal complaints.

While the trend toward surveillance of small asymptomatic lesions is growing, Dr. Huang said surgery is still the treatment mode for more than half of cases. Most procedures in the retrospective study were radical nephrectomies, with kidney removal in about half of those. "The majority of these small lesions could be removed laparoscopically, but even then you’re taking out normal kidney tissue that you might really want back someday," he said at a press briefing at the Genitourinary Cancers Symposium, sponsored by the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

"Physicians can comfortably tell an elderly patient, especially a patient who is not healthy enough to tolerate general anesthesia and surgery, that the likelihood of dying of kidney cancer is low and that kidney surgery is unlikely to extend their lives," he said. "However, since it is difficult to identify which tumors will become lethal, elderly patients who are completely healthy and have an extended life expectancy, may opt for surgery."

The study examined mortality data in the Surveillance, Epidemiology, and End Results database for 8,317 patients, aged 66 years or older, who were diagnosed from 2002 to 2007 with kidney tumors smaller than 1.5 cm. The patients were followed for a median of 59 months; 78% were managed with surgery and 22%, with surveillance. The use of surveillance increased over the course of the study, from about 25% in 2002 to almost 40% in 2007.

Over the study period, 2,078 (25%) of the patients died, including 277 (3%) who died of kidney cancer. At least one cardiovascular event occurred in 24% of the patients.

Kidney cancer mortality rates did not vary between the treatment groups. However, surgical patients had a significantly increased risk of death from any cause. At 7-36 months, those who had surveillance were 30% less likely to have died than those managed by surgery (hazard ratio, 0.70). After 36 months, patients were 63% less likely to have died if their tumors were managed by surveillance instead of surgery (HR, 0.37).

Dr. Huang also demonstrated that those in the surveillance group experienced a significant cardiovascular benefit as well. By the end of the study, 25% of the deaths were due to a cardiovascular event. Patients in the surveillance group had a 49% reduction in the chance of an event.

Dr. Huang said he had no relevant financial disclosures.

[email protected]

Editor’s Note: This editorial is based on the Presidential Address given by Dr. Jurkovich at the 2012 annual meeting of the Western Surgical Association.

Regionalization of health care is part of the larger dynamic of change in medicine that includes an aging population, financing reform, and generational identity issues of physicians in training and future providers of care. Trauma systems provide a model for effective regionalized care, and in this context, I propose a network of national acute care surgery hospitals built on this model. But there are lessons that can be learned from 35 years of trauma systems development and implementation that can be applied to a network of national acute care surgery hospitals (J. Am. Coll. Surg. 2012;215:1-11).

The problem of lack of emergency surgical resources has been noted since the beginning of the 21st century, and has received considerable attention from a wide variety of public and private organizations and government agencies. A cover story of U.S. News and World Report in 2001 was entitled "Crisis in the ER." The influential Institute of Medicine (IOM) three-volume report in 2009 entitled "Future of Emergency Care" noted that hospital-based emergency care was as the breaking point, with overcrowding of emergency departments (ED), boarding of patients in the ED, with ambulance diversion and uncompensated care being the most pressing problems. The Robert Wood Johnson foundation report authored by Dr. Mitesh B. Rao and his colleagues in 2011 highlighted the shortage of surgeons who take emergency call and suggested that "three-quarters of the nations’ emergency departments do not have enough on-call coverage by surgical specialists to meet the demand for round-the-clock specialty care."

One of the key solutions suggested in the IOM report was to develop regionalized on-call specialty care services. The concept is that if hospitals cannot find willing (or able) surgical coverage for certain surgical urgencies or emergencies, then the patients should be sent to regionalized centers of care that can provide these services. The burden on the patient is significant: The patient may have to travel some distance to receive health care. The burden on the receiving hospital is also significant: The patients often are the most challenging and underfunded in medicine. The burden on the profession of surgery is also significant, if often overlooked: a further erosion of the perception of our profession from one concerned primarily with the sick and suffering and to a perception that specialty surgeons are more concerned about lifestyle and personal gain. Nonetheless, this does appear to be the best model for the future of surgical care. The purpose of regionalization of care is to consolidate complex and high-technology medicine into regional centers with adequate surgeons in all specialties, in the hope that this will ensure quality and cost-effective care. It is an opportunity for surgical leadership to become involved in this dramatic change in medicine.

Regionalization: The trauma system model

In 1976, the American College of Surgeons Committee on Trauma published the first version of "The optimal resources for a hospital." The eighth version will be released shortly. This document is the authoritative source on trauma center function. Initially developed to serve as a guideline for what resources were required for a hospital trauma center, a name change in 1990 to "Resources for Optimal Care of the Injured Patients" expanded the implications and reach of these guidelines (J. Trauma 1998;47(3 Suppl.):S1).

What makes trauma center care better? In a study of 31 academic Level 1 trauma centers, the higher volume trauma centers (more than 650 major trauma admissions per year) had improved outcomes, particularly for the sickest patients (JAMA 2001;285:1164-71).

Improved critical care also seems partially responsible for better outcomes at trauma centers. The ability of trauma centers to salvage patients with complications or severe shock and injury appears to be a defining characteristic of those centers with the better outcomes. In addition, trauma intensive care units that are "closed" and staffed by surgical critical care surgeons achieve the best results (J. Trauma 2011;70:575-82; Arch. Surg. 2003;138:47-51;discussion 51; J. Trauma 2006;60:773-83;discussion 783-4; Ann. Surg. 2006;244:545-54).

The reasons trauma centers have improved outcomes appears to be multifactorial, injury-pattern dependent, and not entirely understood. It appears it is not just the hospital designation that makes the difference, but the design and effectiveness of system integration that is equally important.

These examples emphasize the point that a series of activities and actions is required for regionalizing care, not simply forcing a specific population of patients into one hospital. The model trauma system plan written by the HRSA in 1992, with help from the ACS Committee on Trauma and CDC continues to serve as the benchmark for trauma system design (Health Resources and Services Administration. A 2002 national assessment of state trauma system development, emergency medical services resources, and disaster readiness for mass casualty events. Washington: U.S. Department of Health and Human Services, 2003). This plan is based on work and definitions first described by West et al., and modified by Bazzoli et al. (JAMA 1995;273:395-401; JAMA 1988;259:3597-600).

The essential components of a trauma system are designating hospitals as having a specific range of resources, proscribing prehospital triage protocols that allow the selective bypassing of nontrauma centers or lower levels of care, requiring inter-facility transfer agreements, developing quality assurance programs with teeth and the ability to impact change, ensuring regional or state-wide coverage, and importantly, limiting the number of centers based on need for patient care. These steps are rarely accomplished voluntarily, but require government regulations that also provide financial incentives to cover the large number of uninsured trauma patients.

The effectiveness of this approach to regionalized care is remarkable. A recent paper looked at 2.7 million trauma patients from the National Inpatient Sampling (NIS) data between 1995 and 2003 (JAMA 1988;259:3597-600). This paper defined major trauma as patients with a mortality risk of 10% or greater based on injury severity as calculated using ICD-9–based Injury Severity Score (ICISS). They defined high-volume trauma centers as those that treat 915 or more major trauma patients a year. In the United States, only 7% of hospitals meet this threshold, yet they provide 60% of the total major trauma volume care in this country (Figure 7). That’s effective regionalization. That’s an effective concentration of resources that saves lives.

National Trauma and Acute Care Surgery Center Network: A Proposal

I would like to propose the creation of a national network of high-volume, high-acuity trauma and acute care surgery medical centers. Let’s call this the National Trauma and Acute Care Surgery Centers Network (NTACS Network). There are currently about 200 Level 1 trauma centers in the United States, with 107 verified by the American College of Surgeons (ACS) and the rest verified by state agencies using similar (but not exactly the same) criteria. The ideal population volume per Level 1 trauma center is under discussion, but probably a minimum of 1-3 million people per Level 1 trauma center is most appropriate. Any fewer and the volume of cases is diluted and efficiency of concentration and expertise is lost. As the population of the United States is about 300 million people, the ideal number of trauma centers would be between 100 and 300. I tend to favor fewer Level 1 centers, and a greater concentration of the most difficult cases and expertise. So, for the purposes of this proposal, let’s say one NTACS Center for every 2.5 million people, meaning a network of 120 such centers across the country would be required. This density of trauma centers is readily met (and often exceeded) in urban and suburban environments, but is more difficult to achieve in the rural Western states.

Staffing and resources for this NTACS Network would be consistent with what the ACS requires for verification of Level 1 trauma centers. From the standpoint of surgical coverage, a cadre of general surgeons with specific training and expertise in trauma, surgical critical care, and emergency general surgery – the acute care surgeon model – would be ideal coverage for this type of center (J. Trauma 2005;58:614-6; Surgery 2007;141:293-6).

Eight to ten such surgeons, with resident and/or mid-level providers, would provide coverage for surgical critical care, emergency general surgery, trauma surgery, research and education, and administrative duties, implying a need for 960-1,200 such surgeons. These surgeons would provide primary surgical care for trauma, critical care, and emergency and elective general surgery, with 1 night a week in house on call, and time for research and administration, and adequate vacation and sick-leave coverage.

A strategy for interesting the new generation of surgeons in this national network of trauma and acute care surgical centers could focus on incentives to draw the best and brightest. Loan forgiveness programs for medical school education could be applied to surgeons working in such centers. Volunteers could be recruited, perhaps establishing an AmeriCorps for physicians. With adequate manpower, fixed time off, set schedules, and protected time after night coverage and for academic activities would be easier to arrange. Fixed minimum incomes with volume and work performance incentives could be applied. Malpractice limits, similar to the protection state and federal agencies enjoy, could be applied. Facilities participating in the network could readily become academic centers of excellence. The academic productivity and clinical research material from a well-organized network of such facilities would be phenomenal, and serve as the model for multicenter trials and studies of a wide array of interventions, procedures, and practices. Standardization of care would be much easier to obtain, as would dissemination of new information and practices.

The cost for this national network of trauma and acute care surgery centers can be estimated, if only on the back of a napkin at this point. If each hospital had about 300-400 beds, and an estimated annual operating budget of $600 million, the total operating costs for 120 such centers would be $72 billion. If one-half of that money came from third-party health care insurance sources, the federal costs would be about $36 billion, certainly less than the $50 billion proposed in the 2012 Veterans Affairs budget for direct medical care (Office of Management and Budget, Fiscal Year 2012 Budget of the U.S. Government. Washington: USGPO, 2012. p. 137-49). These figures can be compared with the wide range of public dollars spent by communities to provide safety-net coverage. For example, the city and county of Denver budgets about $27 million annually to Denver Health, while the city of San Francisco supports San Francisco General with about $38 million annually from their general fund.

How close are we to having the manpower to meet the needs of such a network of hospitals? Over the past 4 years, 10%-12% of the current 1,100 graduates of general surgery training programs go on to do a surgical critical care residency. That’s actually more than or equal to vascular, pediatrics, hand, or thoracic surgery specialty training. In 2009 there were 2,583 surgeons who take their board in surgical critical care, and 1,204 of them have been recertified at least once (J. Trauma 2010;69:1619-3).

In addition, there is the ongoing development of acute care surgery training programs, spearheaded by the American Association for the Surgery of Trauma, with a goal of 20-30 such training programs. (J. Trauma 2005;58:614-6; J. Trauma 2007;62:553-6; J. Trauma Acute Care Surg. 2012;72:4-10; J. Trauma 2010;68:753-60).

So we have the manpower, and we have a great distribution of trauma centers across this country, with authoritative legislation in most of the states. A total of 83% of the population is within 1 hour of trauma center care by ambulance or helicopter (JAMA 2005;293:2626-33).

Western rural states have the unsolved problem of adequate access to trauma center care, primarily because the population density cannot support such highly specialized centers. But with improved organization of regionalized transportation, this issue could be addressed, and these patients and resources concentrated. Urban America has a different problem in some locations, which is the oversubscribing of trauma centers because of ego, greed, lack of cooperation, and a presumed drive for prestige. This problem could be solved with legislation and changes in funding for trauma and acute care.

Trauma care systems are a model for regionalization of all time-sensitive illnesses, not just trauma, and not just surgical issues; the integrated trauma system model can be the future of regionalization of all health care.

Dr. Jurkovich, an ACS Fellow, is chief of surgery at Denver Health, and vice chairman of surgery, University of Colorado in Denver.

Editor’s Note: This editorial is based on the Presidential Address given by Dr. Jurkovich at the 2012 annual meeting of the Western Surgical Association.

Regionalization of health care is part of the larger dynamic of change in medicine that includes an aging population, financing reform, and generational identity issues of physicians in training and future providers of care. Trauma systems provide a model for effective regionalized care, and in this context, I propose a network of national acute care surgery hospitals built on this model. But there are lessons that can be learned from 35 years of trauma systems development and implementation that can be applied to a network of national acute care surgery hospitals (J. Am. Coll. Surg. 2012;215:1-11).

The problem of lack of emergency surgical resources has been noted since the beginning of the 21st century, and has received considerable attention from a wide variety of public and private organizations and government agencies. A cover story of U.S. News and World Report in 2001 was entitled "Crisis in the ER." The influential Institute of Medicine (IOM) three-volume report in 2009 entitled "Future of Emergency Care" noted that hospital-based emergency care was as the breaking point, with overcrowding of emergency departments (ED), boarding of patients in the ED, with ambulance diversion and uncompensated care being the most pressing problems. The Robert Wood Johnson foundation report authored by Dr. Mitesh B. Rao and his colleagues in 2011 highlighted the shortage of surgeons who take emergency call and suggested that "three-quarters of the nations’ emergency departments do not have enough on-call coverage by surgical specialists to meet the demand for round-the-clock specialty care."

One of the key solutions suggested in the IOM report was to develop regionalized on-call specialty care services. The concept is that if hospitals cannot find willing (or able) surgical coverage for certain surgical urgencies or emergencies, then the patients should be sent to regionalized centers of care that can provide these services. The burden on the patient is significant: The patient may have to travel some distance to receive health care. The burden on the receiving hospital is also significant: The patients often are the most challenging and underfunded in medicine. The burden on the profession of surgery is also significant, if often overlooked: a further erosion of the perception of our profession from one concerned primarily with the sick and suffering and to a perception that specialty surgeons are more concerned about lifestyle and personal gain. Nonetheless, this does appear to be the best model for the future of surgical care. The purpose of regionalization of care is to consolidate complex and high-technology medicine into regional centers with adequate surgeons in all specialties, in the hope that this will ensure quality and cost-effective care. It is an opportunity for surgical leadership to become involved in this dramatic change in medicine.

Regionalization: The trauma system model

In 1976, the American College of Surgeons Committee on Trauma published the first version of "The optimal resources for a hospital." The eighth version will be released shortly. This document is the authoritative source on trauma center function. Initially developed to serve as a guideline for what resources were required for a hospital trauma center, a name change in 1990 to "Resources for Optimal Care of the Injured Patients" expanded the implications and reach of these guidelines (J. Trauma 1998;47(3 Suppl.):S1).

What makes trauma center care better? In a study of 31 academic Level 1 trauma centers, the higher volume trauma centers (more than 650 major trauma admissions per year) had improved outcomes, particularly for the sickest patients (JAMA 2001;285:1164-71).

Improved critical care also seems partially responsible for better outcomes at trauma centers. The ability of trauma centers to salvage patients with complications or severe shock and injury appears to be a defining characteristic of those centers with the better outcomes. In addition, trauma intensive care units that are "closed" and staffed by surgical critical care surgeons achieve the best results (J. Trauma 2011;70:575-82; Arch. Surg. 2003;138:47-51;discussion 51; J. Trauma 2006;60:773-83;discussion 783-4; Ann. Surg. 2006;244:545-54).

The reasons trauma centers have improved outcomes appears to be multifactorial, injury-pattern dependent, and not entirely understood. It appears it is not just the hospital designation that makes the difference, but the design and effectiveness of system integration that is equally important.

These examples emphasize the point that a series of activities and actions is required for regionalizing care, not simply forcing a specific population of patients into one hospital. The model trauma system plan written by the HRSA in 1992, with help from the ACS Committee on Trauma and CDC continues to serve as the benchmark for trauma system design (Health Resources and Services Administration. A 2002 national assessment of state trauma system development, emergency medical services resources, and disaster readiness for mass casualty events. Washington: U.S. Department of Health and Human Services, 2003). This plan is based on work and definitions first described by West et al., and modified by Bazzoli et al. (JAMA 1995;273:395-401; JAMA 1988;259:3597-600).

The essential components of a trauma system are designating hospitals as having a specific range of resources, proscribing prehospital triage protocols that allow the selective bypassing of nontrauma centers or lower levels of care, requiring inter-facility transfer agreements, developing quality assurance programs with teeth and the ability to impact change, ensuring regional or state-wide coverage, and importantly, limiting the number of centers based on need for patient care. These steps are rarely accomplished voluntarily, but require government regulations that also provide financial incentives to cover the large number of uninsured trauma patients.

The effectiveness of this approach to regionalized care is remarkable. A recent paper looked at 2.7 million trauma patients from the National Inpatient Sampling (NIS) data between 1995 and 2003 (JAMA 1988;259:3597-600). This paper defined major trauma as patients with a mortality risk of 10% or greater based on injury severity as calculated using ICD-9–based Injury Severity Score (ICISS). They defined high-volume trauma centers as those that treat 915 or more major trauma patients a year. In the United States, only 7% of hospitals meet this threshold, yet they provide 60% of the total major trauma volume care in this country (Figure 7). That’s effective regionalization. That’s an effective concentration of resources that saves lives.

National Trauma and Acute Care Surgery Center Network: A Proposal

I would like to propose the creation of a national network of high-volume, high-acuity trauma and acute care surgery medical centers. Let’s call this the National Trauma and Acute Care Surgery Centers Network (NTACS Network). There are currently about 200 Level 1 trauma centers in the United States, with 107 verified by the American College of Surgeons (ACS) and the rest verified by state agencies using similar (but not exactly the same) criteria. The ideal population volume per Level 1 trauma center is under discussion, but probably a minimum of 1-3 million people per Level 1 trauma center is most appropriate. Any fewer and the volume of cases is diluted and efficiency of concentration and expertise is lost. As the population of the United States is about 300 million people, the ideal number of trauma centers would be between 100 and 300. I tend to favor fewer Level 1 centers, and a greater concentration of the most difficult cases and expertise. So, for the purposes of this proposal, let’s say one NTACS Center for every 2.5 million people, meaning a network of 120 such centers across the country would be required. This density of trauma centers is readily met (and often exceeded) in urban and suburban environments, but is more difficult to achieve in the rural Western states.

Staffing and resources for this NTACS Network would be consistent with what the ACS requires for verification of Level 1 trauma centers. From the standpoint of surgical coverage, a cadre of general surgeons with specific training and expertise in trauma, surgical critical care, and emergency general surgery – the acute care surgeon model – would be ideal coverage for this type of center (J. Trauma 2005;58:614-6; Surgery 2007;141:293-6).

Eight to ten such surgeons, with resident and/or mid-level providers, would provide coverage for surgical critical care, emergency general surgery, trauma surgery, research and education, and administrative duties, implying a need for 960-1,200 such surgeons. These surgeons would provide primary surgical care for trauma, critical care, and emergency and elective general surgery, with 1 night a week in house on call, and time for research and administration, and adequate vacation and sick-leave coverage.

A strategy for interesting the new generation of surgeons in this national network of trauma and acute care surgical centers could focus on incentives to draw the best and brightest. Loan forgiveness programs for medical school education could be applied to surgeons working in such centers. Volunteers could be recruited, perhaps establishing an AmeriCorps for physicians. With adequate manpower, fixed time off, set schedules, and protected time after night coverage and for academic activities would be easier to arrange. Fixed minimum incomes with volume and work performance incentives could be applied. Malpractice limits, similar to the protection state and federal agencies enjoy, could be applied. Facilities participating in the network could readily become academic centers of excellence. The academic productivity and clinical research material from a well-organized network of such facilities would be phenomenal, and serve as the model for multicenter trials and studies of a wide array of interventions, procedures, and practices. Standardization of care would be much easier to obtain, as would dissemination of new information and practices.

The cost for this national network of trauma and acute care surgery centers can be estimated, if only on the back of a napkin at this point. If each hospital had about 300-400 beds, and an estimated annual operating budget of $600 million, the total operating costs for 120 such centers would be $72 billion. If one-half of that money came from third-party health care insurance sources, the federal costs would be about $36 billion, certainly less than the $50 billion proposed in the 2012 Veterans Affairs budget for direct medical care (Office of Management and Budget, Fiscal Year 2012 Budget of the U.S. Government. Washington: USGPO, 2012. p. 137-49). These figures can be compared with the wide range of public dollars spent by communities to provide safety-net coverage. For example, the city and county of Denver budgets about $27 million annually to Denver Health, while the city of San Francisco supports San Francisco General with about $38 million annually from their general fund.

How close are we to having the manpower to meet the needs of such a network of hospitals? Over the past 4 years, 10%-12% of the current 1,100 graduates of general surgery training programs go on to do a surgical critical care residency. That’s actually more than or equal to vascular, pediatrics, hand, or thoracic surgery specialty training. In 2009 there were 2,583 surgeons who take their board in surgical critical care, and 1,204 of them have been recertified at least once (J. Trauma 2010;69:1619-3).

In addition, there is the ongoing development of acute care surgery training programs, spearheaded by the American Association for the Surgery of Trauma, with a goal of 20-30 such training programs. (J. Trauma 2005;58:614-6; J. Trauma 2007;62:553-6; J. Trauma Acute Care Surg. 2012;72:4-10; J. Trauma 2010;68:753-60).

So we have the manpower, and we have a great distribution of trauma centers across this country, with authoritative legislation in most of the states. A total of 83% of the population is within 1 hour of trauma center care by ambulance or helicopter (JAMA 2005;293:2626-33).

Western rural states have the unsolved problem of adequate access to trauma center care, primarily because the population density cannot support such highly specialized centers. But with improved organization of regionalized transportation, this issue could be addressed, and these patients and resources concentrated. Urban America has a different problem in some locations, which is the oversubscribing of trauma centers because of ego, greed, lack of cooperation, and a presumed drive for prestige. This problem could be solved with legislation and changes in funding for trauma and acute care.

Trauma care systems are a model for regionalization of all time-sensitive illnesses, not just trauma, and not just surgical issues; the integrated trauma system model can be the future of regionalization of all health care.

Dr. Jurkovich, an ACS Fellow, is chief of surgery at Denver Health, and vice chairman of surgery, University of Colorado in Denver.

Editor’s Note: This editorial is based on the Presidential Address given by Dr. Jurkovich at the 2012 annual meeting of the Western Surgical Association.

Regionalization of health care is part of the larger dynamic of change in medicine that includes an aging population, financing reform, and generational identity issues of physicians in training and future providers of care. Trauma systems provide a model for effective regionalized care, and in this context, I propose a network of national acute care surgery hospitals built on this model. But there are lessons that can be learned from 35 years of trauma systems development and implementation that can be applied to a network of national acute care surgery hospitals (J. Am. Coll. Surg. 2012;215:1-11).

The problem of lack of emergency surgical resources has been noted since the beginning of the 21st century, and has received considerable attention from a wide variety of public and private organizations and government agencies. A cover story of U.S. News and World Report in 2001 was entitled "Crisis in the ER." The influential Institute of Medicine (IOM) three-volume report in 2009 entitled "Future of Emergency Care" noted that hospital-based emergency care was as the breaking point, with overcrowding of emergency departments (ED), boarding of patients in the ED, with ambulance diversion and uncompensated care being the most pressing problems. The Robert Wood Johnson foundation report authored by Dr. Mitesh B. Rao and his colleagues in 2011 highlighted the shortage of surgeons who take emergency call and suggested that "three-quarters of the nations’ emergency departments do not have enough on-call coverage by surgical specialists to meet the demand for round-the-clock specialty care."

One of the key solutions suggested in the IOM report was to develop regionalized on-call specialty care services. The concept is that if hospitals cannot find willing (or able) surgical coverage for certain surgical urgencies or emergencies, then the patients should be sent to regionalized centers of care that can provide these services. The burden on the patient is significant: The patient may have to travel some distance to receive health care. The burden on the receiving hospital is also significant: The patients often are the most challenging and underfunded in medicine. The burden on the profession of surgery is also significant, if often overlooked: a further erosion of the perception of our profession from one concerned primarily with the sick and suffering and to a perception that specialty surgeons are more concerned about lifestyle and personal gain. Nonetheless, this does appear to be the best model for the future of surgical care. The purpose of regionalization of care is to consolidate complex and high-technology medicine into regional centers with adequate surgeons in all specialties, in the hope that this will ensure quality and cost-effective care. It is an opportunity for surgical leadership to become involved in this dramatic change in medicine.

Regionalization: The trauma system model

In 1976, the American College of Surgeons Committee on Trauma published the first version of "The optimal resources for a hospital." The eighth version will be released shortly. This document is the authoritative source on trauma center function. Initially developed to serve as a guideline for what resources were required for a hospital trauma center, a name change in 1990 to "Resources for Optimal Care of the Injured Patients" expanded the implications and reach of these guidelines (J. Trauma 1998;47(3 Suppl.):S1).

What makes trauma center care better? In a study of 31 academic Level 1 trauma centers, the higher volume trauma centers (more than 650 major trauma admissions per year) had improved outcomes, particularly for the sickest patients (JAMA 2001;285:1164-71).

Improved critical care also seems partially responsible for better outcomes at trauma centers. The ability of trauma centers to salvage patients with complications or severe shock and injury appears to be a defining characteristic of those centers with the better outcomes. In addition, trauma intensive care units that are "closed" and staffed by surgical critical care surgeons achieve the best results (J. Trauma 2011;70:575-82; Arch. Surg. 2003;138:47-51;discussion 51; J. Trauma 2006;60:773-83;discussion 783-4; Ann. Surg. 2006;244:545-54).

The reasons trauma centers have improved outcomes appears to be multifactorial, injury-pattern dependent, and not entirely understood. It appears it is not just the hospital designation that makes the difference, but the design and effectiveness of system integration that is equally important.

These examples emphasize the point that a series of activities and actions is required for regionalizing care, not simply forcing a specific population of patients into one hospital. The model trauma system plan written by the HRSA in 1992, with help from the ACS Committee on Trauma and CDC continues to serve as the benchmark for trauma system design (Health Resources and Services Administration. A 2002 national assessment of state trauma system development, emergency medical services resources, and disaster readiness for mass casualty events. Washington: U.S. Department of Health and Human Services, 2003). This plan is based on work and definitions first described by West et al., and modified by Bazzoli et al. (JAMA 1995;273:395-401; JAMA 1988;259:3597-600).

The essential components of a trauma system are designating hospitals as having a specific range of resources, proscribing prehospital triage protocols that allow the selective bypassing of nontrauma centers or lower levels of care, requiring inter-facility transfer agreements, developing quality assurance programs with teeth and the ability to impact change, ensuring regional or state-wide coverage, and importantly, limiting the number of centers based on need for patient care. These steps are rarely accomplished voluntarily, but require government regulations that also provide financial incentives to cover the large number of uninsured trauma patients.

The effectiveness of this approach to regionalized care is remarkable. A recent paper looked at 2.7 million trauma patients from the National Inpatient Sampling (NIS) data between 1995 and 2003 (JAMA 1988;259:3597-600). This paper defined major trauma as patients with a mortality risk of 10% or greater based on injury severity as calculated using ICD-9–based Injury Severity Score (ICISS). They defined high-volume trauma centers as those that treat 915 or more major trauma patients a year. In the United States, only 7% of hospitals meet this threshold, yet they provide 60% of the total major trauma volume care in this country (Figure 7). That’s effective regionalization. That’s an effective concentration of resources that saves lives.

National Trauma and Acute Care Surgery Center Network: A Proposal

I would like to propose the creation of a national network of high-volume, high-acuity trauma and acute care surgery medical centers. Let’s call this the National Trauma and Acute Care Surgery Centers Network (NTACS Network). There are currently about 200 Level 1 trauma centers in the United States, with 107 verified by the American College of Surgeons (ACS) and the rest verified by state agencies using similar (but not exactly the same) criteria. The ideal population volume per Level 1 trauma center is under discussion, but probably a minimum of 1-3 million people per Level 1 trauma center is most appropriate. Any fewer and the volume of cases is diluted and efficiency of concentration and expertise is lost. As the population of the United States is about 300 million people, the ideal number of trauma centers would be between 100 and 300. I tend to favor fewer Level 1 centers, and a greater concentration of the most difficult cases and expertise. So, for the purposes of this proposal, let’s say one NTACS Center for every 2.5 million people, meaning a network of 120 such centers across the country would be required. This density of trauma centers is readily met (and often exceeded) in urban and suburban environments, but is more difficult to achieve in the rural Western states.

Staffing and resources for this NTACS Network would be consistent with what the ACS requires for verification of Level 1 trauma centers. From the standpoint of surgical coverage, a cadre of general surgeons with specific training and expertise in trauma, surgical critical care, and emergency general surgery – the acute care surgeon model – would be ideal coverage for this type of center (J. Trauma 2005;58:614-6; Surgery 2007;141:293-6).

Eight to ten such surgeons, with resident and/or mid-level providers, would provide coverage for surgical critical care, emergency general surgery, trauma surgery, research and education, and administrative duties, implying a need for 960-1,200 such surgeons. These surgeons would provide primary surgical care for trauma, critical care, and emergency and elective general surgery, with 1 night a week in house on call, and time for research and administration, and adequate vacation and sick-leave coverage.

A strategy for interesting the new generation of surgeons in this national network of trauma and acute care surgical centers could focus on incentives to draw the best and brightest. Loan forgiveness programs for medical school education could be applied to surgeons working in such centers. Volunteers could be recruited, perhaps establishing an AmeriCorps for physicians. With adequate manpower, fixed time off, set schedules, and protected time after night coverage and for academic activities would be easier to arrange. Fixed minimum incomes with volume and work performance incentives could be applied. Malpractice limits, similar to the protection state and federal agencies enjoy, could be applied. Facilities participating in the network could readily become academic centers of excellence. The academic productivity and clinical research material from a well-organized network of such facilities would be phenomenal, and serve as the model for multicenter trials and studies of a wide array of interventions, procedures, and practices. Standardization of care would be much easier to obtain, as would dissemination of new information and practices.

The cost for this national network of trauma and acute care surgery centers can be estimated, if only on the back of a napkin at this point. If each hospital had about 300-400 beds, and an estimated annual operating budget of $600 million, the total operating costs for 120 such centers would be $72 billion. If one-half of that money came from third-party health care insurance sources, the federal costs would be about $36 billion, certainly less than the $50 billion proposed in the 2012 Veterans Affairs budget for direct medical care (Office of Management and Budget, Fiscal Year 2012 Budget of the U.S. Government. Washington: USGPO, 2012. p. 137-49). These figures can be compared with the wide range of public dollars spent by communities to provide safety-net coverage. For example, the city and county of Denver budgets about $27 million annually to Denver Health, while the city of San Francisco supports San Francisco General with about $38 million annually from their general fund.

How close are we to having the manpower to meet the needs of such a network of hospitals? Over the past 4 years, 10%-12% of the current 1,100 graduates of general surgery training programs go on to do a surgical critical care residency. That’s actually more than or equal to vascular, pediatrics, hand, or thoracic surgery specialty training. In 2009 there were 2,583 surgeons who take their board in surgical critical care, and 1,204 of them have been recertified at least once (J. Trauma 2010;69:1619-3).

In addition, there is the ongoing development of acute care surgery training programs, spearheaded by the American Association for the Surgery of Trauma, with a goal of 20-30 such training programs. (J. Trauma 2005;58:614-6; J. Trauma 2007;62:553-6; J. Trauma Acute Care Surg. 2012;72:4-10; J. Trauma 2010;68:753-60).

So we have the manpower, and we have a great distribution of trauma centers across this country, with authoritative legislation in most of the states. A total of 83% of the population is within 1 hour of trauma center care by ambulance or helicopter (JAMA 2005;293:2626-33).

Western rural states have the unsolved problem of adequate access to trauma center care, primarily because the population density cannot support such highly specialized centers. But with improved organization of regionalized transportation, this issue could be addressed, and these patients and resources concentrated. Urban America has a different problem in some locations, which is the oversubscribing of trauma centers because of ego, greed, lack of cooperation, and a presumed drive for prestige. This problem could be solved with legislation and changes in funding for trauma and acute care.

Trauma care systems are a model for regionalization of all time-sensitive illnesses, not just trauma, and not just surgical issues; the integrated trauma system model can be the future of regionalization of all health care.

Dr. Jurkovich, an ACS Fellow, is chief of surgery at Denver Health, and vice chairman of surgery, University of Colorado in Denver.

Men who underwent radiotherapy for localized high-risk prostate cancer and had 18 months of androgen blockade did just as well as comparable men who had 3 years of androgen blockade.

The finding of nearly identical overall and disease-free survival with traditional and shortened hormone therapy is "practice changing," Dr. Bruce Roth said during a press briefing at the 2013 Genitourinary Cancers Symposium.

"I would be willing to change the way I treat my patients," based on the results of the phase III study, said Dr. Roth of Washington University, St. Louis. "The consequences of long-term androgen deprivation are often more striking than the positive aspects of prolonging it. If treatment time can be safely halved, patients will enjoy a much better quality of life."

Dr. Abdenour Nabid of the Centre Hospitalier Universitaire de Sherbrooke, Canada, headed the study. It randomized 630 men with node-negative high-risk prostate cancer to radiation therapy plus either 36 or 18 months of androgen blockade. The hormone therapy consisted of bicalutamide 50 mg/day for 1 month plus goserelin 10.8 mg given as an injection once every 3 months.

At baseline, the patients were a median of 71 years old; the median prostate specific antigen (PSA) level was 16 ng/mL, and the median Gleason score was 8. Most had T2-T3 disease.

The median follow-up period was about 77 months. At that point, 23% of patients in the extended therapy group and 24% in the abbreviated therapy group had died. Of these 147 patients, 116 (79%) had died from causes other than prostate cancer.

Fifty patients developed bone metastases, Dr. Nabid said, but there was not a significant between-group difference in this outcome. Nor were there differences in biochemical failure, regional or distant recurrence, pelvic metastases, or the need for a second course of androgen blockade.

When Dr. Nabid broke the data out by 5- and 10-year follow-up points, the survival results were similar. At 5 years, overall survival was 92% in the 36-month group and 87% in the 18-month group; disease specific survival was 98% and 96%, respectively. At 10 years, overall survival was 64% vs. 63%, and disease-specific survival was 87% in both groups.

He said the study will follow all patients through 10 years, adding "I am convinced this finding won’t change."

Decreasing the length of androgen blockade could avoid some cases of permanent castration syndrome, Dr. Roth said. "The longer the hormone therapy, the less chance that testosterone will recover when it’s finished. With 3 years of hormone therapy, you might be inducing a lifetime of hormone suppression" and a host of problems including sexual dysfunction, loss of muscle tone, and increased visceral fat. These consequences are in turn associated with significantly increased rates of metabolic syndrome, diabetes, myocardial infarction, and coronary heart disease.

"If a patient has several decades left of life and his testosterone levels are lowered to the point of castration syndrome, there is a price to pay," Dr. Roth said. "If this patient dies of a heart attack 10 years before he would have died of prostate cancer, we have not really provided good anticancer therapy."

This is the first study showing that short-term androgen blockade is both safe and effective. "Could we get by with less?" Dr. Nabid asked. "We don’t know. Previous trials have shown that 6 months of hormone treatment is inferior to 24 months, but we don’t know what the effect of 12 months would be. Still, we are excited to see this, and our hope is that this will change the standard of care for this stage of disease."

Dr. Nabid had no financial disclosures.

[email protected]

Men who underwent radiotherapy for localized high-risk prostate cancer and had 18 months of androgen blockade did just as well as comparable men who had 3 years of androgen blockade.

The finding of nearly identical overall and disease-free survival with traditional and shortened hormone therapy is "practice changing," Dr. Bruce Roth said during a press briefing at the 2013 Genitourinary Cancers Symposium.

"I would be willing to change the way I treat my patients," based on the results of the phase III study, said Dr. Roth of Washington University, St. Louis. "The consequences of long-term androgen deprivation are often more striking than the positive aspects of prolonging it. If treatment time can be safely halved, patients will enjoy a much better quality of life."

Dr. Abdenour Nabid of the Centre Hospitalier Universitaire de Sherbrooke, Canada, headed the study. It randomized 630 men with node-negative high-risk prostate cancer to radiation therapy plus either 36 or 18 months of androgen blockade. The hormone therapy consisted of bicalutamide 50 mg/day for 1 month plus goserelin 10.8 mg given as an injection once every 3 months.

At baseline, the patients were a median of 71 years old; the median prostate specific antigen (PSA) level was 16 ng/mL, and the median Gleason score was 8. Most had T2-T3 disease.

The median follow-up period was about 77 months. At that point, 23% of patients in the extended therapy group and 24% in the abbreviated therapy group had died. Of these 147 patients, 116 (79%) had died from causes other than prostate cancer.

Fifty patients developed bone metastases, Dr. Nabid said, but there was not a significant between-group difference in this outcome. Nor were there differences in biochemical failure, regional or distant recurrence, pelvic metastases, or the need for a second course of androgen blockade.

When Dr. Nabid broke the data out by 5- and 10-year follow-up points, the survival results were similar. At 5 years, overall survival was 92% in the 36-month group and 87% in the 18-month group; disease specific survival was 98% and 96%, respectively. At 10 years, overall survival was 64% vs. 63%, and disease-specific survival was 87% in both groups.

He said the study will follow all patients through 10 years, adding "I am convinced this finding won’t change."

Decreasing the length of androgen blockade could avoid some cases of permanent castration syndrome, Dr. Roth said. "The longer the hormone therapy, the less chance that testosterone will recover when it’s finished. With 3 years of hormone therapy, you might be inducing a lifetime of hormone suppression" and a host of problems including sexual dysfunction, loss of muscle tone, and increased visceral fat. These consequences are in turn associated with significantly increased rates of metabolic syndrome, diabetes, myocardial infarction, and coronary heart disease.

"If a patient has several decades left of life and his testosterone levels are lowered to the point of castration syndrome, there is a price to pay," Dr. Roth said. "If this patient dies of a heart attack 10 years before he would have died of prostate cancer, we have not really provided good anticancer therapy."

This is the first study showing that short-term androgen blockade is both safe and effective. "Could we get by with less?" Dr. Nabid asked. "We don’t know. Previous trials have shown that 6 months of hormone treatment is inferior to 24 months, but we don’t know what the effect of 12 months would be. Still, we are excited to see this, and our hope is that this will change the standard of care for this stage of disease."

Dr. Nabid had no financial disclosures.

[email protected]

Men who underwent radiotherapy for localized high-risk prostate cancer and had 18 months of androgen blockade did just as well as comparable men who had 3 years of androgen blockade.

The finding of nearly identical overall and disease-free survival with traditional and shortened hormone therapy is "practice changing," Dr. Bruce Roth said during a press briefing at the 2013 Genitourinary Cancers Symposium.

"I would be willing to change the way I treat my patients," based on the results of the phase III study, said Dr. Roth of Washington University, St. Louis. "The consequences of long-term androgen deprivation are often more striking than the positive aspects of prolonging it. If treatment time can be safely halved, patients will enjoy a much better quality of life."

Dr. Abdenour Nabid of the Centre Hospitalier Universitaire de Sherbrooke, Canada, headed the study. It randomized 630 men with node-negative high-risk prostate cancer to radiation therapy plus either 36 or 18 months of androgen blockade. The hormone therapy consisted of bicalutamide 50 mg/day for 1 month plus goserelin 10.8 mg given as an injection once every 3 months.

At baseline, the patients were a median of 71 years old; the median prostate specific antigen (PSA) level was 16 ng/mL, and the median Gleason score was 8. Most had T2-T3 disease.

The median follow-up period was about 77 months. At that point, 23% of patients in the extended therapy group and 24% in the abbreviated therapy group had died. Of these 147 patients, 116 (79%) had died from causes other than prostate cancer.

Fifty patients developed bone metastases, Dr. Nabid said, but there was not a significant between-group difference in this outcome. Nor were there differences in biochemical failure, regional or distant recurrence, pelvic metastases, or the need for a second course of androgen blockade.

When Dr. Nabid broke the data out by 5- and 10-year follow-up points, the survival results were similar. At 5 years, overall survival was 92% in the 36-month group and 87% in the 18-month group; disease specific survival was 98% and 96%, respectively. At 10 years, overall survival was 64% vs. 63%, and disease-specific survival was 87% in both groups.

He said the study will follow all patients through 10 years, adding "I am convinced this finding won’t change."

Decreasing the length of androgen blockade could avoid some cases of permanent castration syndrome, Dr. Roth said. "The longer the hormone therapy, the less chance that testosterone will recover when it’s finished. With 3 years of hormone therapy, you might be inducing a lifetime of hormone suppression" and a host of problems including sexual dysfunction, loss of muscle tone, and increased visceral fat. These consequences are in turn associated with significantly increased rates of metabolic syndrome, diabetes, myocardial infarction, and coronary heart disease.

"If a patient has several decades left of life and his testosterone levels are lowered to the point of castration syndrome, there is a price to pay," Dr. Roth said. "If this patient dies of a heart attack 10 years before he would have died of prostate cancer, we have not really provided good anticancer therapy."

This is the first study showing that short-term androgen blockade is both safe and effective. "Could we get by with less?" Dr. Nabid asked. "We don’t know. Previous trials have shown that 6 months of hormone treatment is inferior to 24 months, but we don’t know what the effect of 12 months would be. Still, we are excited to see this, and our hope is that this will change the standard of care for this stage of disease."

Dr. Nabid had no financial disclosures.

[email protected]

Falsified and substandard drugs are a global public health threat that needs to be addressed cooperatively by governments, manufacturers, and other health organizations, according to an Institute of Medicine report issued Feb. 13.

This is "a grave public health problem because [falsified and substandard drugs] are ineffective, promote drug resistance, and even cause severe illness and death, particularly in developing countries where they regularly flood the market," chair of the report committee, Lawrence Gostin, O’Neill Professor of Global Health Law, Georgetown University Law Center in Washington, said in a statement.

"Given the international nature of modern manufacturing and trade, every nation has a stake and a role to play in ensuring the production and sale of high-quality medications," he said.

The IOM committee is calling on the World Health Organization, other international organizations, governments, and stakeholders to collaborate on "a global code of practice, build national regulatory capabilities, and promote international cooperation."

The committee was convened by the IOM at the request of the Food and Drug Administration. In a statement, Commissioner Margaret A. Hamburg noted that the FDA is transforming from a "predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world," and that many of the recommendations in the IOM report are already underway, including having a presence in 12 countries in seven regions of the world.

Quite simply, the first thing that needs to be done, according to the report, is for the World Health Assembly to adopt consistent definitions, using "substandard" to describe drugs that do not meet pharmacopeia or manufacturer specifications, and "falsified" for those products with a "false representation" of identity and/or source.

To avoid confusion, the report recommends against using the term counterfeit, which, although widely used to refer to drugs that do not contain what they claim to, has a narrow legal definition related to infringement of registered trademarks.

Available in street markets, unregulated websites, and other unreliable sources, falsified and substandard drugs cause problems ranging from a lack of a therapeutic effect and resistance to antimalarial and tuberculosis treatments to frank poisoning.

While it is difficult to quantify the magnitude of the problem, the report cites some data, including the finding by 25 major pharmaceutical companies that in 2011, falsified or substandard drugs were sold in at least 124 countries. And although poorer countries are disproportionately affected, richer countries are impacted too. The report specifically cites the recent case of the Massachusetts compounding company that produced contaminated injectable steroid products, which caused many cases of meningitis, including 44 cases that were fatal in a 5-month period.

"Lack of clarity about the relative authority of the FDA and state pharmacy councils to regulate compounding pharmacies contributed to the outbreak," the report noted.

Another key recommendation: Establish in the United States a mandatory drug tracking system, and strengthen the requirements for licensing medication wholesalers. The report describes secondary wholesalers as the "weakest point" in the U.S. drug distribution chain. The latter should include the requirement that state licensing boards in the United States only license wholesalers that meet accreditation standards of the National Association of Boards of Pharmacy (NABP), and that the FDA and state licensing boards establish a public database with information on wholesalers with revoked or suspended licenses.

To facilitate the changes, Congress should authorize and fund the FDA to create a mandatory "track and trace system" using unique product serial numbers to track packages of medications from the factory to the consumer, according to the report.

The IOM committee also recommended better training for pharmacy staff in developing countries and improved communication and training programs to educate health care workers and consumers about poor-quality medications and how to report suspected cases.

Funding from international investment agencies should be used to help pharmaceutical manufacturers upgrade to international standards, and for governments in low- and middle-income countries to help their regulatory agencies comply with international manufacturing and quality control standards.

The study was supported by a contract between the National Academy of Sciences and the FDA.

[email protected]

Falsified and substandard drugs are a global public health threat that needs to be addressed cooperatively by governments, manufacturers, and other health organizations, according to an Institute of Medicine report issued Feb. 13.

This is "a grave public health problem because [falsified and substandard drugs] are ineffective, promote drug resistance, and even cause severe illness and death, particularly in developing countries where they regularly flood the market," chair of the report committee, Lawrence Gostin, O’Neill Professor of Global Health Law, Georgetown University Law Center in Washington, said in a statement.

"Given the international nature of modern manufacturing and trade, every nation has a stake and a role to play in ensuring the production and sale of high-quality medications," he said.

The IOM committee is calling on the World Health Organization, other international organizations, governments, and stakeholders to collaborate on "a global code of practice, build national regulatory capabilities, and promote international cooperation."

The committee was convened by the IOM at the request of the Food and Drug Administration. In a statement, Commissioner Margaret A. Hamburg noted that the FDA is transforming from a "predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world," and that many of the recommendations in the IOM report are already underway, including having a presence in 12 countries in seven regions of the world.

Quite simply, the first thing that needs to be done, according to the report, is for the World Health Assembly to adopt consistent definitions, using "substandard" to describe drugs that do not meet pharmacopeia or manufacturer specifications, and "falsified" for those products with a "false representation" of identity and/or source.

To avoid confusion, the report recommends against using the term counterfeit, which, although widely used to refer to drugs that do not contain what they claim to, has a narrow legal definition related to infringement of registered trademarks.

Available in street markets, unregulated websites, and other unreliable sources, falsified and substandard drugs cause problems ranging from a lack of a therapeutic effect and resistance to antimalarial and tuberculosis treatments to frank poisoning.

While it is difficult to quantify the magnitude of the problem, the report cites some data, including the finding by 25 major pharmaceutical companies that in 2011, falsified or substandard drugs were sold in at least 124 countries. And although poorer countries are disproportionately affected, richer countries are impacted too. The report specifically cites the recent case of the Massachusetts compounding company that produced contaminated injectable steroid products, which caused many cases of meningitis, including 44 cases that were fatal in a 5-month period.

"Lack of clarity about the relative authority of the FDA and state pharmacy councils to regulate compounding pharmacies contributed to the outbreak," the report noted.

Another key recommendation: Establish in the United States a mandatory drug tracking system, and strengthen the requirements for licensing medication wholesalers. The report describes secondary wholesalers as the "weakest point" in the U.S. drug distribution chain. The latter should include the requirement that state licensing boards in the United States only license wholesalers that meet accreditation standards of the National Association of Boards of Pharmacy (NABP), and that the FDA and state licensing boards establish a public database with information on wholesalers with revoked or suspended licenses.

To facilitate the changes, Congress should authorize and fund the FDA to create a mandatory "track and trace system" using unique product serial numbers to track packages of medications from the factory to the consumer, according to the report.

The IOM committee also recommended better training for pharmacy staff in developing countries and improved communication and training programs to educate health care workers and consumers about poor-quality medications and how to report suspected cases.

Funding from international investment agencies should be used to help pharmaceutical manufacturers upgrade to international standards, and for governments in low- and middle-income countries to help their regulatory agencies comply with international manufacturing and quality control standards.

The study was supported by a contract between the National Academy of Sciences and the FDA.

[email protected]

Falsified and substandard drugs are a global public health threat that needs to be addressed cooperatively by governments, manufacturers, and other health organizations, according to an Institute of Medicine report issued Feb. 13.

This is "a grave public health problem because [falsified and substandard drugs] are ineffective, promote drug resistance, and even cause severe illness and death, particularly in developing countries where they regularly flood the market," chair of the report committee, Lawrence Gostin, O’Neill Professor of Global Health Law, Georgetown University Law Center in Washington, said in a statement.

"Given the international nature of modern manufacturing and trade, every nation has a stake and a role to play in ensuring the production and sale of high-quality medications," he said.

The IOM committee is calling on the World Health Organization, other international organizations, governments, and stakeholders to collaborate on "a global code of practice, build national regulatory capabilities, and promote international cooperation."

The committee was convened by the IOM at the request of the Food and Drug Administration. In a statement, Commissioner Margaret A. Hamburg noted that the FDA is transforming from a "predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world," and that many of the recommendations in the IOM report are already underway, including having a presence in 12 countries in seven regions of the world.

Quite simply, the first thing that needs to be done, according to the report, is for the World Health Assembly to adopt consistent definitions, using "substandard" to describe drugs that do not meet pharmacopeia or manufacturer specifications, and "falsified" for those products with a "false representation" of identity and/or source.

To avoid confusion, the report recommends against using the term counterfeit, which, although widely used to refer to drugs that do not contain what they claim to, has a narrow legal definition related to infringement of registered trademarks.

Available in street markets, unregulated websites, and other unreliable sources, falsified and substandard drugs cause problems ranging from a lack of a therapeutic effect and resistance to antimalarial and tuberculosis treatments to frank poisoning.

While it is difficult to quantify the magnitude of the problem, the report cites some data, including the finding by 25 major pharmaceutical companies that in 2011, falsified or substandard drugs were sold in at least 124 countries. And although poorer countries are disproportionately affected, richer countries are impacted too. The report specifically cites the recent case of the Massachusetts compounding company that produced contaminated injectable steroid products, which caused many cases of meningitis, including 44 cases that were fatal in a 5-month period.

"Lack of clarity about the relative authority of the FDA and state pharmacy councils to regulate compounding pharmacies contributed to the outbreak," the report noted.

Another key recommendation: Establish in the United States a mandatory drug tracking system, and strengthen the requirements for licensing medication wholesalers. The report describes secondary wholesalers as the "weakest point" in the U.S. drug distribution chain. The latter should include the requirement that state licensing boards in the United States only license wholesalers that meet accreditation standards of the National Association of Boards of Pharmacy (NABP), and that the FDA and state licensing boards establish a public database with information on wholesalers with revoked or suspended licenses.

To facilitate the changes, Congress should authorize and fund the FDA to create a mandatory "track and trace system" using unique product serial numbers to track packages of medications from the factory to the consumer, according to the report.

The IOM committee also recommended better training for pharmacy staff in developing countries and improved communication and training programs to educate health care workers and consumers about poor-quality medications and how to report suspected cases.

Funding from international investment agencies should be used to help pharmaceutical manufacturers upgrade to international standards, and for governments in low- and middle-income countries to help their regulatory agencies comply with international manufacturing and quality control standards.

The study was supported by a contract between the National Academy of Sciences and the FDA.

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