ACS Surgery News

LONDON – The European League Against Rheumatism and the European Federation of National Associations of Orthopaedics and Traumatology have joined forces to develop recommendations for the prevention and management of fragility fractures.

Such fractures are common in men and women over the age of 50 years and can lead to repeat fracture in some patients. The recommendations are unique as they are the first to consider both acute orthopedic and postfracture rheumatologic care, said Willem F. Lems, MD, PhD, of the Amsterdam Rheumatology and Immunology Centre.

At the European Congress of Rheumatology, Dr. Lems provided an overview of the draft recommendations, noting that there would be several overarching principles, one of which recognized the multidisciplinary nature of caring for someone with a fragility fracture. An important point is not who is taking care of the patient, but that the patient is given the best possible care within the multidisciplinary framework.

Wikimedia Commons/Sjoehest/ CC BY-llSA 3.0

What constitutes optimal care of course depends on the clinical situation, notably the type of fracture and the age of the patient, and optimal care in all phases of presentation (pre-, peri- and postoperative) can have an important effect on a patient’s outcome. The prevention of subsequent fractures is a key focus, with the recommendation that all patients should be investigated systematically and those deemed at high risk for another fracture should be prescribed both pharmacologic and nonpharmacologic interventions as appropriate. Patient education is also considered important.

As for all EULAR-developed recommendations, standard procedures were followed that involved convening an expert scientific advisory committee and using the Delphi technique to come up with the most important research questions that would be used to formulate the final 10 recommendations. Four of the recommendations cover the acute care setting and six provide advice on postfracture care.

The first of the acute care recommendations looks at pre- and perioperative management of a fragility fracture and highlights that, within 24-48 hours of admission, patients should receive adequate pain and fluid management and treatment, including early surgery if appropriate. This is based on evidence that better outcomes can be achieved in terms of both morbidity and mortality if patients can be seen and managed quickly.

Another of the acute care recommendations focuses on orthogeriatric care, noting that the orthopedic surgeon and a dedicated orthogeriatric team should work together, particularly for elderly patients who have suffered a hip fracture. Key elements here are the management of and prevention of delirium, deep vein thrombosis, pressure sores, and malnutrition.

As for actual fracture treatment, a balanced approach is advised when deciding upon a surgical or nonsurgical approach, especially because this is likely to be an older population with other comorbidities. Only one in three vertebral fractures are symptomatic and only about 10% of patients will be hospitalized for pain. Analgesics, modifying activities, and bracing can be options here. Surgical options for distal radial fracture, hip fracture, and trochanteric and femoral neck fractures are included.

The fourth recommendation looks at the organization of postfracture care and the need for a systematic approach to identify those who may be at risk for subsequent fractures, starting with the suggestion that any patient older than 50 years with a recent fracture should be assessed. The fifth recommendation addresses ways to evaluate this risk, such as looking at the clinical risk factors, performing bone scans and imaging, and screening for underlying osteoporosis or metabolic disorders.

Implementation is the next step, and the sixth recommendation suggests ways these recommendations could be integrated into routine practice. Often one of the biggest barriers to effective postfracture care is the lack of patient, and sometimes clinician, awareness of the risk for a subsequent fracture. This recommendation looks at the role of a possible local fracture liaison service or facilitator to coordinate between the various members of the multidisciplinary team from secondary (orthopedic surgeons, rheumatologists, endocrinologists, and geriatricians) to primary care.

The seventh recommendation addresses rehabilitation and the need to initiate physical training and muscle strengthening as early as possible after the initial fracture, with long-term continuation of balance training and fall prevention.

The final three recommendations focus on how to educate patients about their risk factors, need for follow-up, and the duration of any pharmacologic or nonpharmacologic therapy that they may need. Nonpharmacologic options might include stopping smoking, limiting alcohol intake, as well as taking supplements such as calcium or vitamin D. There will be specific guidance on the use of calcium and vitamin D, which have both pros and cons, but the optimal dosage appears to be 1,000–1,200 mg/day for calcium and 800 IU/day for vitamin D.

Pharmacologic options to prevent subsequent fragility fractures include the bisphosphonates alendronate, risedronate, and zoledronic acid (Reclast), and also the monoclonal antibody denosumab (Prolia). These are the only drugs that have been shown to reduced the risk for vertebral, nonvertebral, and hip fractures in primary analyses. Adherence, tolerance, and regular monitoring are key, and a five-step plan is suggested to aid clinical decision making that covers case finding, risk evaluation, differential diagnosis, treatment, and follow-up.

The recommendations are being finalized and should be available for publication later this year. The recommendations task force also plans to propose a research agenda.

Dr. Lems had no relevant disclosures.

LONDON – The European League Against Rheumatism and the European Federation of National Associations of Orthopaedics and Traumatology have joined forces to develop recommendations for the prevention and management of fragility fractures.

Such fractures are common in men and women over the age of 50 years and can lead to repeat fracture in some patients. The recommendations are unique as they are the first to consider both acute orthopedic and postfracture rheumatologic care, said Willem F. Lems, MD, PhD, of the Amsterdam Rheumatology and Immunology Centre.

At the European Congress of Rheumatology, Dr. Lems provided an overview of the draft recommendations, noting that there would be several overarching principles, one of which recognized the multidisciplinary nature of caring for someone with a fragility fracture. An important point is not who is taking care of the patient, but that the patient is given the best possible care within the multidisciplinary framework.

Wikimedia Commons/Sjoehest/ CC BY-llSA 3.0

What constitutes optimal care of course depends on the clinical situation, notably the type of fracture and the age of the patient, and optimal care in all phases of presentation (pre-, peri- and postoperative) can have an important effect on a patient’s outcome. The prevention of subsequent fractures is a key focus, with the recommendation that all patients should be investigated systematically and those deemed at high risk for another fracture should be prescribed both pharmacologic and nonpharmacologic interventions as appropriate. Patient education is also considered important.

As for all EULAR-developed recommendations, standard procedures were followed that involved convening an expert scientific advisory committee and using the Delphi technique to come up with the most important research questions that would be used to formulate the final 10 recommendations. Four of the recommendations cover the acute care setting and six provide advice on postfracture care.

The first of the acute care recommendations looks at pre- and perioperative management of a fragility fracture and highlights that, within 24-48 hours of admission, patients should receive adequate pain and fluid management and treatment, including early surgery if appropriate. This is based on evidence that better outcomes can be achieved in terms of both morbidity and mortality if patients can be seen and managed quickly.

Another of the acute care recommendations focuses on orthogeriatric care, noting that the orthopedic surgeon and a dedicated orthogeriatric team should work together, particularly for elderly patients who have suffered a hip fracture. Key elements here are the management of and prevention of delirium, deep vein thrombosis, pressure sores, and malnutrition.

As for actual fracture treatment, a balanced approach is advised when deciding upon a surgical or nonsurgical approach, especially because this is likely to be an older population with other comorbidities. Only one in three vertebral fractures are symptomatic and only about 10% of patients will be hospitalized for pain. Analgesics, modifying activities, and bracing can be options here. Surgical options for distal radial fracture, hip fracture, and trochanteric and femoral neck fractures are included.

The fourth recommendation looks at the organization of postfracture care and the need for a systematic approach to identify those who may be at risk for subsequent fractures, starting with the suggestion that any patient older than 50 years with a recent fracture should be assessed. The fifth recommendation addresses ways to evaluate this risk, such as looking at the clinical risk factors, performing bone scans and imaging, and screening for underlying osteoporosis or metabolic disorders.

Implementation is the next step, and the sixth recommendation suggests ways these recommendations could be integrated into routine practice. Often one of the biggest barriers to effective postfracture care is the lack of patient, and sometimes clinician, awareness of the risk for a subsequent fracture. This recommendation looks at the role of a possible local fracture liaison service or facilitator to coordinate between the various members of the multidisciplinary team from secondary (orthopedic surgeons, rheumatologists, endocrinologists, and geriatricians) to primary care.

The seventh recommendation addresses rehabilitation and the need to initiate physical training and muscle strengthening as early as possible after the initial fracture, with long-term continuation of balance training and fall prevention.

The final three recommendations focus on how to educate patients about their risk factors, need for follow-up, and the duration of any pharmacologic or nonpharmacologic therapy that they may need. Nonpharmacologic options might include stopping smoking, limiting alcohol intake, as well as taking supplements such as calcium or vitamin D. There will be specific guidance on the use of calcium and vitamin D, which have both pros and cons, but the optimal dosage appears to be 1,000–1,200 mg/day for calcium and 800 IU/day for vitamin D.

Pharmacologic options to prevent subsequent fragility fractures include the bisphosphonates alendronate, risedronate, and zoledronic acid (Reclast), and also the monoclonal antibody denosumab (Prolia). These are the only drugs that have been shown to reduced the risk for vertebral, nonvertebral, and hip fractures in primary analyses. Adherence, tolerance, and regular monitoring are key, and a five-step plan is suggested to aid clinical decision making that covers case finding, risk evaluation, differential diagnosis, treatment, and follow-up.

The recommendations are being finalized and should be available for publication later this year. The recommendations task force also plans to propose a research agenda.

Dr. Lems had no relevant disclosures.

LONDON – The European League Against Rheumatism and the European Federation of National Associations of Orthopaedics and Traumatology have joined forces to develop recommendations for the prevention and management of fragility fractures.

Such fractures are common in men and women over the age of 50 years and can lead to repeat fracture in some patients. The recommendations are unique as they are the first to consider both acute orthopedic and postfracture rheumatologic care, said Willem F. Lems, MD, PhD, of the Amsterdam Rheumatology and Immunology Centre.

At the European Congress of Rheumatology, Dr. Lems provided an overview of the draft recommendations, noting that there would be several overarching principles, one of which recognized the multidisciplinary nature of caring for someone with a fragility fracture. An important point is not who is taking care of the patient, but that the patient is given the best possible care within the multidisciplinary framework.

Wikimedia Commons/Sjoehest/ CC BY-llSA 3.0

What constitutes optimal care of course depends on the clinical situation, notably the type of fracture and the age of the patient, and optimal care in all phases of presentation (pre-, peri- and postoperative) can have an important effect on a patient’s outcome. The prevention of subsequent fractures is a key focus, with the recommendation that all patients should be investigated systematically and those deemed at high risk for another fracture should be prescribed both pharmacologic and nonpharmacologic interventions as appropriate. Patient education is also considered important.

As for all EULAR-developed recommendations, standard procedures were followed that involved convening an expert scientific advisory committee and using the Delphi technique to come up with the most important research questions that would be used to formulate the final 10 recommendations. Four of the recommendations cover the acute care setting and six provide advice on postfracture care.

The first of the acute care recommendations looks at pre- and perioperative management of a fragility fracture and highlights that, within 24-48 hours of admission, patients should receive adequate pain and fluid management and treatment, including early surgery if appropriate. This is based on evidence that better outcomes can be achieved in terms of both morbidity and mortality if patients can be seen and managed quickly.

Another of the acute care recommendations focuses on orthogeriatric care, noting that the orthopedic surgeon and a dedicated orthogeriatric team should work together, particularly for elderly patients who have suffered a hip fracture. Key elements here are the management of and prevention of delirium, deep vein thrombosis, pressure sores, and malnutrition.

As for actual fracture treatment, a balanced approach is advised when deciding upon a surgical or nonsurgical approach, especially because this is likely to be an older population with other comorbidities. Only one in three vertebral fractures are symptomatic and only about 10% of patients will be hospitalized for pain. Analgesics, modifying activities, and bracing can be options here. Surgical options for distal radial fracture, hip fracture, and trochanteric and femoral neck fractures are included.

The fourth recommendation looks at the organization of postfracture care and the need for a systematic approach to identify those who may be at risk for subsequent fractures, starting with the suggestion that any patient older than 50 years with a recent fracture should be assessed. The fifth recommendation addresses ways to evaluate this risk, such as looking at the clinical risk factors, performing bone scans and imaging, and screening for underlying osteoporosis or metabolic disorders.

Implementation is the next step, and the sixth recommendation suggests ways these recommendations could be integrated into routine practice. Often one of the biggest barriers to effective postfracture care is the lack of patient, and sometimes clinician, awareness of the risk for a subsequent fracture. This recommendation looks at the role of a possible local fracture liaison service or facilitator to coordinate between the various members of the multidisciplinary team from secondary (orthopedic surgeons, rheumatologists, endocrinologists, and geriatricians) to primary care.

The seventh recommendation addresses rehabilitation and the need to initiate physical training and muscle strengthening as early as possible after the initial fracture, with long-term continuation of balance training and fall prevention.

The final three recommendations focus on how to educate patients about their risk factors, need for follow-up, and the duration of any pharmacologic or nonpharmacologic therapy that they may need. Nonpharmacologic options might include stopping smoking, limiting alcohol intake, as well as taking supplements such as calcium or vitamin D. There will be specific guidance on the use of calcium and vitamin D, which have both pros and cons, but the optimal dosage appears to be 1,000–1,200 mg/day for calcium and 800 IU/day for vitamin D.

Pharmacologic options to prevent subsequent fragility fractures include the bisphosphonates alendronate, risedronate, and zoledronic acid (Reclast), and also the monoclonal antibody denosumab (Prolia). These are the only drugs that have been shown to reduced the risk for vertebral, nonvertebral, and hip fractures in primary analyses. Adherence, tolerance, and regular monitoring are key, and a five-step plan is suggested to aid clinical decision making that covers case finding, risk evaluation, differential diagnosis, treatment, and follow-up.

The recommendations are being finalized and should be available for publication later this year. The recommendations task force also plans to propose a research agenda.

Dr. Lems had no relevant disclosures.

While euthanasia and physician-assisted suicide increasingly are being legalized around the world, there appears to be little evidence that vulnerable patients are being targeted by abuse of the practice, researchers say.

A review published in the July 5 edition of JAMA examined surveys and death certification studies from countries and jurisdictions where physician-assisted suicide, euthanasia or both have been legalized, to explore attitudes and practices.

©aga7ta/Thinkstock

Currently, physician-assisted suicide is legal in five U.S. states – California, Montana, Oregon, Vermont, and Washington – while euthanasia or physician-assisted suicide is legal in Belgium, Canada, Colombia, Luxembourg, the Netherlands, and Switzerland, (JAMA 2016;316:79-90. doi: 10.1001/jama.2016.8499).

The review found evidence suggesting that in the United States, physician-assisted suicide accounts for less than 0.4% of all deaths. In Belgium and the Netherlands, that prevalence is much higher; the most recent studies suggested that 4.6% of all deaths in Belgium and 2.9% of all deaths in the Netherlands can be attributed to euthanasia or physician-assisted suicide, and there is the suggestion that this proportion is increasing over time.

The authors also addressed the so-called “slippery slope” argument, which posits that legalization of euthanasia or physician-assisted suicide would see its expansion to include patients who had not explicitly requested it. They noted that the incidence of deaths resulting from administration of lethal drugs without explicit patient consent appeared to have declined from 0.8% of deaths in the Netherlands in 1990 to 0.2% of deaths in 2010.

Similarly in Belgium, these deaths without explicit patient consent were estimated to be around 3.2% of deaths before legalization and 1.7% of deaths in 2013, after legalization.

“There is much debate concerning performing euthanasia, physician-assisted suicide, or other life-ending procedures on patients with dementia or chronic mental illness, who are minors, who are just “tired of life,” or who are socioeconomically vulnerable,” wrote Dr. Ezekiel J. Emanuel, vice provost for global initiatives and professor and chair of the department of medical ethics and health policy medical ethics and health policy at the University of Pennsylvania in Philadelphia, and coauthors.

However they cited a survey of Dutch physicians which found that only 2% of requests for euthanasia or physician-assisted suicide were from patients with a psychiatric disease, 4% were from patients with dementia, and 3% were from patients with neither a serious physical or psychiatric disease.

“In the United States, the concern that minorities, the disabled, the poor, or other socioeconomically marginalized groups might be pressured to accept [physician-assisted suicide] does not seem to be borne out,” the authors wrote. “The demographic profile of patients in the United States who have received these interventions is white, well-educated, and well-insured.”

The majority of cases of physician-assisted suicide or euthanasia in the Netherlands and Belgium – 70% – occur in patients with cancer, and 6% are among individuals with a neurodegenerative disease.

The authors also examined changing attitudes among the general public and among physicians towards physician-assisted suicide and euthanasia. They found that public support has declined slightly in the United States, from 75% in 2005 to 64% in 2012, but pointed out that assessing attitudes was challenging because of “framing effects” in surveys.

“Support varies substantially depending on the wording of survey questions; the provision of details about the patients, their prognosis, their medical diagnosis, and symptoms; how the interventions are characterized; and whether the questions are focused on ethical acceptability, legalization, or some other endorsement.”

Support for euthanasia and physician-assisted suicide has increased in most Western European nations but has either plateaued or decreased in much of Central and Eastern Europe.

“These changes seem correlated with a strong decline in religiosity in Western Europe and an increase in religiosity in post-communist Eastern Europe,” the authors suggested.

Physician surveys experience the same framing issues, but the authors cited a 2014 Medscape survey of physicians in seven countries which found that 54% of U.S. respondents agreed that physician-assisted suicide should be allowed, compared with 47% of respondents in Germany and the U.K., 42% in Italy, 30% in France, and 36% in Spain.

No conflicts of interest were reported.

While euthanasia and physician-assisted suicide increasingly are being legalized around the world, there appears to be little evidence that vulnerable patients are being targeted by abuse of the practice, researchers say.

A review published in the July 5 edition of JAMA examined surveys and death certification studies from countries and jurisdictions where physician-assisted suicide, euthanasia or both have been legalized, to explore attitudes and practices.

©aga7ta/Thinkstock

Currently, physician-assisted suicide is legal in five U.S. states – California, Montana, Oregon, Vermont, and Washington – while euthanasia or physician-assisted suicide is legal in Belgium, Canada, Colombia, Luxembourg, the Netherlands, and Switzerland, (JAMA 2016;316:79-90. doi: 10.1001/jama.2016.8499).

The review found evidence suggesting that in the United States, physician-assisted suicide accounts for less than 0.4% of all deaths. In Belgium and the Netherlands, that prevalence is much higher; the most recent studies suggested that 4.6% of all deaths in Belgium and 2.9% of all deaths in the Netherlands can be attributed to euthanasia or physician-assisted suicide, and there is the suggestion that this proportion is increasing over time.

The authors also addressed the so-called “slippery slope” argument, which posits that legalization of euthanasia or physician-assisted suicide would see its expansion to include patients who had not explicitly requested it. They noted that the incidence of deaths resulting from administration of lethal drugs without explicit patient consent appeared to have declined from 0.8% of deaths in the Netherlands in 1990 to 0.2% of deaths in 2010.

Similarly in Belgium, these deaths without explicit patient consent were estimated to be around 3.2% of deaths before legalization and 1.7% of deaths in 2013, after legalization.

“There is much debate concerning performing euthanasia, physician-assisted suicide, or other life-ending procedures on patients with dementia or chronic mental illness, who are minors, who are just “tired of life,” or who are socioeconomically vulnerable,” wrote Dr. Ezekiel J. Emanuel, vice provost for global initiatives and professor and chair of the department of medical ethics and health policy medical ethics and health policy at the University of Pennsylvania in Philadelphia, and coauthors.

However they cited a survey of Dutch physicians which found that only 2% of requests for euthanasia or physician-assisted suicide were from patients with a psychiatric disease, 4% were from patients with dementia, and 3% were from patients with neither a serious physical or psychiatric disease.

“In the United States, the concern that minorities, the disabled, the poor, or other socioeconomically marginalized groups might be pressured to accept [physician-assisted suicide] does not seem to be borne out,” the authors wrote. “The demographic profile of patients in the United States who have received these interventions is white, well-educated, and well-insured.”

The majority of cases of physician-assisted suicide or euthanasia in the Netherlands and Belgium – 70% – occur in patients with cancer, and 6% are among individuals with a neurodegenerative disease.

The authors also examined changing attitudes among the general public and among physicians towards physician-assisted suicide and euthanasia. They found that public support has declined slightly in the United States, from 75% in 2005 to 64% in 2012, but pointed out that assessing attitudes was challenging because of “framing effects” in surveys.

“Support varies substantially depending on the wording of survey questions; the provision of details about the patients, their prognosis, their medical diagnosis, and symptoms; how the interventions are characterized; and whether the questions are focused on ethical acceptability, legalization, or some other endorsement.”

Support for euthanasia and physician-assisted suicide has increased in most Western European nations but has either plateaued or decreased in much of Central and Eastern Europe.

“These changes seem correlated with a strong decline in religiosity in Western Europe and an increase in religiosity in post-communist Eastern Europe,” the authors suggested.

Physician surveys experience the same framing issues, but the authors cited a 2014 Medscape survey of physicians in seven countries which found that 54% of U.S. respondents agreed that physician-assisted suicide should be allowed, compared with 47% of respondents in Germany and the U.K., 42% in Italy, 30% in France, and 36% in Spain.

No conflicts of interest were reported.

While euthanasia and physician-assisted suicide increasingly are being legalized around the world, there appears to be little evidence that vulnerable patients are being targeted by abuse of the practice, researchers say.

A review published in the July 5 edition of JAMA examined surveys and death certification studies from countries and jurisdictions where physician-assisted suicide, euthanasia or both have been legalized, to explore attitudes and practices.

©aga7ta/Thinkstock

Currently, physician-assisted suicide is legal in five U.S. states – California, Montana, Oregon, Vermont, and Washington – while euthanasia or physician-assisted suicide is legal in Belgium, Canada, Colombia, Luxembourg, the Netherlands, and Switzerland, (JAMA 2016;316:79-90. doi: 10.1001/jama.2016.8499).

The review found evidence suggesting that in the United States, physician-assisted suicide accounts for less than 0.4% of all deaths. In Belgium and the Netherlands, that prevalence is much higher; the most recent studies suggested that 4.6% of all deaths in Belgium and 2.9% of all deaths in the Netherlands can be attributed to euthanasia or physician-assisted suicide, and there is the suggestion that this proportion is increasing over time.

The authors also addressed the so-called “slippery slope” argument, which posits that legalization of euthanasia or physician-assisted suicide would see its expansion to include patients who had not explicitly requested it. They noted that the incidence of deaths resulting from administration of lethal drugs without explicit patient consent appeared to have declined from 0.8% of deaths in the Netherlands in 1990 to 0.2% of deaths in 2010.

Similarly in Belgium, these deaths without explicit patient consent were estimated to be around 3.2% of deaths before legalization and 1.7% of deaths in 2013, after legalization.

“There is much debate concerning performing euthanasia, physician-assisted suicide, or other life-ending procedures on patients with dementia or chronic mental illness, who are minors, who are just “tired of life,” or who are socioeconomically vulnerable,” wrote Dr. Ezekiel J. Emanuel, vice provost for global initiatives and professor and chair of the department of medical ethics and health policy medical ethics and health policy at the University of Pennsylvania in Philadelphia, and coauthors.

However they cited a survey of Dutch physicians which found that only 2% of requests for euthanasia or physician-assisted suicide were from patients with a psychiatric disease, 4% were from patients with dementia, and 3% were from patients with neither a serious physical or psychiatric disease.

“In the United States, the concern that minorities, the disabled, the poor, or other socioeconomically marginalized groups might be pressured to accept [physician-assisted suicide] does not seem to be borne out,” the authors wrote. “The demographic profile of patients in the United States who have received these interventions is white, well-educated, and well-insured.”

The majority of cases of physician-assisted suicide or euthanasia in the Netherlands and Belgium – 70% – occur in patients with cancer, and 6% are among individuals with a neurodegenerative disease.

The authors also examined changing attitudes among the general public and among physicians towards physician-assisted suicide and euthanasia. They found that public support has declined slightly in the United States, from 75% in 2005 to 64% in 2012, but pointed out that assessing attitudes was challenging because of “framing effects” in surveys.

“Support varies substantially depending on the wording of survey questions; the provision of details about the patients, their prognosis, their medical diagnosis, and symptoms; how the interventions are characterized; and whether the questions are focused on ethical acceptability, legalization, or some other endorsement.”

Support for euthanasia and physician-assisted suicide has increased in most Western European nations but has either plateaued or decreased in much of Central and Eastern Europe.

“These changes seem correlated with a strong decline in religiosity in Western Europe and an increase in religiosity in post-communist Eastern Europe,” the authors suggested.

Physician surveys experience the same framing issues, but the authors cited a 2014 Medscape survey of physicians in seven countries which found that 54% of U.S. respondents agreed that physician-assisted suicide should be allowed, compared with 47% of respondents in Germany and the U.K., 42% in Italy, 30% in France, and 36% in Spain.

No conflicts of interest were reported.

PARIS – Below-the-knee plain balloon angioplasty is an effective strategy for limb-salvage in patients with critical limb ischemia who otherwise face the prospect of a major amputation, Ana P. Mollon, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Dr. Mollon of Posadas National Hospital in Buenos Aires, presented a retrospective series of 82 consecutive patients who underwent below-the-knee percutaneous angioplasty for critical limb ischemia with multivessel involvement. The amputation-free survival rate at a mean of 15.1 months of follow-up was 88%.

Bruce Jancin/Frontline Medical News

Sixty of the 82 patients had triple-artery involvement below the knee. The other 22 had two involved arteries. As is typical in patients with critical limb ischemia, comorbid conditions were common: Seventy-five patients had diabetes, 58 were hypertensive, and 48 were current smokers.

Of the 124 arteries treated by Dr. Mollon and coworkers, the posterior tibial artery was addressed in 41% of cases, the anterior tibial artery in 39%, and the peroneal artery in 18%. Two percent of patients received dilatation of plantar arch lesions.

Seventy percent of treated lesions were total occlusions, nearly half of which were more than 5 cm in length.

The treatment was plain balloon angioplasty in 78% of cases, drug-coated balloons in 12%, bare metal stenting in 7%, and drug-eluting stents in 3%. An antegrade approach was used in 95% of cases, and the remainder received a dual antegrade/retrograde approach.

Roughly 80% of patients were Rutherford category 5 or 6 before treatment. At 12 months post angioplasty, most patients were category 1 or 2, and about one-quarter were category 5 or 6.

Angioplasty was unsuccessful in restoring straight line flow in six patients.

All 10 patients who underwent a major amputation had triple-vessel involvement below the knee; in 9 of the 10, interventionalists were able to treat one of the three severely diseased arteries. Five of the 10 amputees had osteomyelitis.

Session chair Flavio Ribichini, MD, applauded Dr. Mollon and her Argentine colleagues for their predominant use of plain balloon angioplasty in this setting.

“I absolutely share your view on this. It’s the simplest and cheapest approach. The point is that you’re saving the foot now. It’s not that important what’s going to happen in 1 year. I don’t think it makes sense to use drug-coated balloons in this setting. It’s much more sensible to use a simple procedure and see how it goes,” said Dr. Ribichini, professor of cardiovascular medicine at the University of Verona (Italy).

Dr. Mollon said that several years ago her group briefly turned to the use of drug-coated balloons for below-the-knee limb salvage, but they soon switched back to plain balloon angioplasty because they didn’t see any advantage in patient outcomes with the more elaborate technology.

Discussant Benjamin Honton, MD, of the Pasteur Clinic in Toulouse, France, said, “We, too, have been disappointed with the drug-coated balloon, especially in the posterior tibial artery.”

Dr. Mollon reported having no financial conflicts.

[email protected]

PARIS – Below-the-knee plain balloon angioplasty is an effective strategy for limb-salvage in patients with critical limb ischemia who otherwise face the prospect of a major amputation, Ana P. Mollon, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Dr. Mollon of Posadas National Hospital in Buenos Aires, presented a retrospective series of 82 consecutive patients who underwent below-the-knee percutaneous angioplasty for critical limb ischemia with multivessel involvement. The amputation-free survival rate at a mean of 15.1 months of follow-up was 88%.

Bruce Jancin/Frontline Medical News

Sixty of the 82 patients had triple-artery involvement below the knee. The other 22 had two involved arteries. As is typical in patients with critical limb ischemia, comorbid conditions were common: Seventy-five patients had diabetes, 58 were hypertensive, and 48 were current smokers.

Of the 124 arteries treated by Dr. Mollon and coworkers, the posterior tibial artery was addressed in 41% of cases, the anterior tibial artery in 39%, and the peroneal artery in 18%. Two percent of patients received dilatation of plantar arch lesions.

Seventy percent of treated lesions were total occlusions, nearly half of which were more than 5 cm in length.

The treatment was plain balloon angioplasty in 78% of cases, drug-coated balloons in 12%, bare metal stenting in 7%, and drug-eluting stents in 3%. An antegrade approach was used in 95% of cases, and the remainder received a dual antegrade/retrograde approach.

Roughly 80% of patients were Rutherford category 5 or 6 before treatment. At 12 months post angioplasty, most patients were category 1 or 2, and about one-quarter were category 5 or 6.

Angioplasty was unsuccessful in restoring straight line flow in six patients.

All 10 patients who underwent a major amputation had triple-vessel involvement below the knee; in 9 of the 10, interventionalists were able to treat one of the three severely diseased arteries. Five of the 10 amputees had osteomyelitis.

Session chair Flavio Ribichini, MD, applauded Dr. Mollon and her Argentine colleagues for their predominant use of plain balloon angioplasty in this setting.

“I absolutely share your view on this. It’s the simplest and cheapest approach. The point is that you’re saving the foot now. It’s not that important what’s going to happen in 1 year. I don’t think it makes sense to use drug-coated balloons in this setting. It’s much more sensible to use a simple procedure and see how it goes,” said Dr. Ribichini, professor of cardiovascular medicine at the University of Verona (Italy).

Dr. Mollon said that several years ago her group briefly turned to the use of drug-coated balloons for below-the-knee limb salvage, but they soon switched back to plain balloon angioplasty because they didn’t see any advantage in patient outcomes with the more elaborate technology.

Discussant Benjamin Honton, MD, of the Pasteur Clinic in Toulouse, France, said, “We, too, have been disappointed with the drug-coated balloon, especially in the posterior tibial artery.”

Dr. Mollon reported having no financial conflicts.

[email protected]

PARIS – Below-the-knee plain balloon angioplasty is an effective strategy for limb-salvage in patients with critical limb ischemia who otherwise face the prospect of a major amputation, Ana P. Mollon, MD, said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Dr. Mollon of Posadas National Hospital in Buenos Aires, presented a retrospective series of 82 consecutive patients who underwent below-the-knee percutaneous angioplasty for critical limb ischemia with multivessel involvement. The amputation-free survival rate at a mean of 15.1 months of follow-up was 88%.

Bruce Jancin/Frontline Medical News

Sixty of the 82 patients had triple-artery involvement below the knee. The other 22 had two involved arteries. As is typical in patients with critical limb ischemia, comorbid conditions were common: Seventy-five patients had diabetes, 58 were hypertensive, and 48 were current smokers.

Of the 124 arteries treated by Dr. Mollon and coworkers, the posterior tibial artery was addressed in 41% of cases, the anterior tibial artery in 39%, and the peroneal artery in 18%. Two percent of patients received dilatation of plantar arch lesions.

Seventy percent of treated lesions were total occlusions, nearly half of which were more than 5 cm in length.

The treatment was plain balloon angioplasty in 78% of cases, drug-coated balloons in 12%, bare metal stenting in 7%, and drug-eluting stents in 3%. An antegrade approach was used in 95% of cases, and the remainder received a dual antegrade/retrograde approach.

Roughly 80% of patients were Rutherford category 5 or 6 before treatment. At 12 months post angioplasty, most patients were category 1 or 2, and about one-quarter were category 5 or 6.

Angioplasty was unsuccessful in restoring straight line flow in six patients.

All 10 patients who underwent a major amputation had triple-vessel involvement below the knee; in 9 of the 10, interventionalists were able to treat one of the three severely diseased arteries. Five of the 10 amputees had osteomyelitis.

Session chair Flavio Ribichini, MD, applauded Dr. Mollon and her Argentine colleagues for their predominant use of plain balloon angioplasty in this setting.

“I absolutely share your view on this. It’s the simplest and cheapest approach. The point is that you’re saving the foot now. It’s not that important what’s going to happen in 1 year. I don’t think it makes sense to use drug-coated balloons in this setting. It’s much more sensible to use a simple procedure and see how it goes,” said Dr. Ribichini, professor of cardiovascular medicine at the University of Verona (Italy).

Dr. Mollon said that several years ago her group briefly turned to the use of drug-coated balloons for below-the-knee limb salvage, but they soon switched back to plain balloon angioplasty because they didn’t see any advantage in patient outcomes with the more elaborate technology.

Discussant Benjamin Honton, MD, of the Pasteur Clinic in Toulouse, France, said, “We, too, have been disappointed with the drug-coated balloon, especially in the posterior tibial artery.”

Dr. Mollon reported having no financial conflicts.

[email protected]

In an effort to streamline multisite clinical research, the National Institutes of Health announced a new policy related to the use of institutional review boards (IRBs).

The new policy sets “the expectation that multisite studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research,” NIH Director Francis S. Collins, MD, said in a June 21 statement. The policy goes into effect May 25, 2017, and applies only to domestic research.

Currently, for most multisite studies, the IRB at each site conducts an independent review of protocol and consent documents, which Dr. Collins said “adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research.”

Michael Pichichero, MD, director of the research institute, Rochester (N.Y.) General Hospital, called the change “a good policy. Allowing a single IRB to review and not go through multiple reviews will help get clinical trials going faster,” he said in an interview. “The policies and principles of IRB review are the same for all U.S. Food and Drug Administration–approved IRBs, so the concern that inappropriate approval might be given is highly unlikely.”

[email protected]

In an effort to streamline multisite clinical research, the National Institutes of Health announced a new policy related to the use of institutional review boards (IRBs).

The new policy sets “the expectation that multisite studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research,” NIH Director Francis S. Collins, MD, said in a June 21 statement. The policy goes into effect May 25, 2017, and applies only to domestic research.

Currently, for most multisite studies, the IRB at each site conducts an independent review of protocol and consent documents, which Dr. Collins said “adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research.”

Michael Pichichero, MD, director of the research institute, Rochester (N.Y.) General Hospital, called the change “a good policy. Allowing a single IRB to review and not go through multiple reviews will help get clinical trials going faster,” he said in an interview. “The policies and principles of IRB review are the same for all U.S. Food and Drug Administration–approved IRBs, so the concern that inappropriate approval might be given is highly unlikely.”

[email protected]

In an effort to streamline multisite clinical research, the National Institutes of Health announced a new policy related to the use of institutional review boards (IRBs).

The new policy sets “the expectation that multisite studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research,” NIH Director Francis S. Collins, MD, said in a June 21 statement. The policy goes into effect May 25, 2017, and applies only to domestic research.

Currently, for most multisite studies, the IRB at each site conducts an independent review of protocol and consent documents, which Dr. Collins said “adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research.”

Michael Pichichero, MD, director of the research institute, Rochester (N.Y.) General Hospital, called the change “a good policy. Allowing a single IRB to review and not go through multiple reviews will help get clinical trials going faster,” he said in an interview. “The policies and principles of IRB review are the same for all U.S. Food and Drug Administration–approved IRBs, so the concern that inappropriate approval might be given is highly unlikely.”

[email protected]

PARIS – When a patient undergoing transcatheter aortic valve replacement needs a permanent pacemaker, the additional hospital costs are significantly less if the device is implanted within 24 hours post TAVR rather than later, Seth Clancy reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“Not only the need for permanent pacemaker implantation but also the timing of the procedure as well as the management and monitoring of conduction disturbances have important resource use implications for TAVR,” observed Mr. Clancy of Edwards Lifesciences of Irvine, Calif.

He presented an economic analysis of all 12,148 TAVR hospitalizations included in the Medicare database for 2014. A key finding: The mean cost of TAVR hospitalizations with no permanent pacemaker implantation was $63,136, while for the 12% of TAVRs that did include permanent pacemaker implantation, the mean cost shot up to $80,441, for a difference of $17,305.

The additional cost of putting in a permanent pacemaker included nearly $8,000 for supplies, more than $2,600 for additional time in the operating room and/or catheterization laboratory, and in excess of $2,100 worth of extra ICU or cardiac care unit time.

Patients who received a permanent pacemaker during their TAVR hospitalization spent an average of 2.3 days longer in the hospital than the mean 6.6 days for patients who didn’t get a permanent pacemaker.

Drilling down further into the data, Mr. Clancy found that 41% of permanent pacemakers implanted during hospitalization for TAVR went in within 24 hours of the TAVR procedure. In a multivariate regression analysis adjusted for differences in patient demographics, comorbid conditions, and complications, those patients generated an average of $9,843 more in hospital costs than patients who didn’t get a permanent pacemaker during their TAVR hospitalization. However, patients who received a permanent pacemaker more than 24 hours after TAVR cost an average of $17,681 more and had a 2.72-day longer stay than patients who didn’t get a permanent pacemaker.

The need for a permanent pacemaker is a common complication following TAVR. This has been a sticking point for many cardiothoracic surgeons, who note that rates of permanent pacemaker implantation following surgical aortic valve replacement are far lower. Still, rates in TAVR patients have come down over time with advances in valve technology. Currently, permanent pacemaker implantation rates in TAVR patients are 5%-25%, depending upon the valve system, according to Mr. Clancy.

Advances in device design and techniques aimed at reducing the permanent pacemaker implantation rate substantially below the 12% figure seen in 2014 have the potential to generate substantial cost savings, he observed.

Session chair Mohammad Abdelghani, MD, of the Academic Medical Center at Amsterdam questioned whether the study results are relevant to European practice because of the large differences in health care costs.

Discussant Sonia Petronio, MD, expressed a more fundamental reservation.

“This is a very important subject – and a very dangerous one,” said Dr. Petronio of the University of Pisa (Italy). “It’s easier and less costly for a hospital to encourage increasing early permanent pacemaker implantation because the patient can go home earlier.”

“We don’t want to put in a pacemaker earlier to save money,” agreed Dr. Abdelghani. “This is not a cost-effectiveness analysis, it’s purely a cost analysis. Cost-effectiveness would take into account the long-term clinical outcomes and welfare of the patients. We would like to see that from you next year.”

Mr. Clancy is an employee of Edwards Lifesciences, which funded the study.

[email protected]

PARIS – When a patient undergoing transcatheter aortic valve replacement needs a permanent pacemaker, the additional hospital costs are significantly less if the device is implanted within 24 hours post TAVR rather than later, Seth Clancy reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“Not only the need for permanent pacemaker implantation but also the timing of the procedure as well as the management and monitoring of conduction disturbances have important resource use implications for TAVR,” observed Mr. Clancy of Edwards Lifesciences of Irvine, Calif.

He presented an economic analysis of all 12,148 TAVR hospitalizations included in the Medicare database for 2014. A key finding: The mean cost of TAVR hospitalizations with no permanent pacemaker implantation was $63,136, while for the 12% of TAVRs that did include permanent pacemaker implantation, the mean cost shot up to $80,441, for a difference of $17,305.

The additional cost of putting in a permanent pacemaker included nearly $8,000 for supplies, more than $2,600 for additional time in the operating room and/or catheterization laboratory, and in excess of $2,100 worth of extra ICU or cardiac care unit time.

Patients who received a permanent pacemaker during their TAVR hospitalization spent an average of 2.3 days longer in the hospital than the mean 6.6 days for patients who didn’t get a permanent pacemaker.

Drilling down further into the data, Mr. Clancy found that 41% of permanent pacemakers implanted during hospitalization for TAVR went in within 24 hours of the TAVR procedure. In a multivariate regression analysis adjusted for differences in patient demographics, comorbid conditions, and complications, those patients generated an average of $9,843 more in hospital costs than patients who didn’t get a permanent pacemaker during their TAVR hospitalization. However, patients who received a permanent pacemaker more than 24 hours after TAVR cost an average of $17,681 more and had a 2.72-day longer stay than patients who didn’t get a permanent pacemaker.

The need for a permanent pacemaker is a common complication following TAVR. This has been a sticking point for many cardiothoracic surgeons, who note that rates of permanent pacemaker implantation following surgical aortic valve replacement are far lower. Still, rates in TAVR patients have come down over time with advances in valve technology. Currently, permanent pacemaker implantation rates in TAVR patients are 5%-25%, depending upon the valve system, according to Mr. Clancy.

Advances in device design and techniques aimed at reducing the permanent pacemaker implantation rate substantially below the 12% figure seen in 2014 have the potential to generate substantial cost savings, he observed.

Session chair Mohammad Abdelghani, MD, of the Academic Medical Center at Amsterdam questioned whether the study results are relevant to European practice because of the large differences in health care costs.

Discussant Sonia Petronio, MD, expressed a more fundamental reservation.

“This is a very important subject – and a very dangerous one,” said Dr. Petronio of the University of Pisa (Italy). “It’s easier and less costly for a hospital to encourage increasing early permanent pacemaker implantation because the patient can go home earlier.”

“We don’t want to put in a pacemaker earlier to save money,” agreed Dr. Abdelghani. “This is not a cost-effectiveness analysis, it’s purely a cost analysis. Cost-effectiveness would take into account the long-term clinical outcomes and welfare of the patients. We would like to see that from you next year.”

Mr. Clancy is an employee of Edwards Lifesciences, which funded the study.

[email protected]

PARIS – When a patient undergoing transcatheter aortic valve replacement needs a permanent pacemaker, the additional hospital costs are significantly less if the device is implanted within 24 hours post TAVR rather than later, Seth Clancy reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“Not only the need for permanent pacemaker implantation but also the timing of the procedure as well as the management and monitoring of conduction disturbances have important resource use implications for TAVR,” observed Mr. Clancy of Edwards Lifesciences of Irvine, Calif.

He presented an economic analysis of all 12,148 TAVR hospitalizations included in the Medicare database for 2014. A key finding: The mean cost of TAVR hospitalizations with no permanent pacemaker implantation was $63,136, while for the 12% of TAVRs that did include permanent pacemaker implantation, the mean cost shot up to $80,441, for a difference of $17,305.

The additional cost of putting in a permanent pacemaker included nearly $8,000 for supplies, more than $2,600 for additional time in the operating room and/or catheterization laboratory, and in excess of $2,100 worth of extra ICU or cardiac care unit time.

Patients who received a permanent pacemaker during their TAVR hospitalization spent an average of 2.3 days longer in the hospital than the mean 6.6 days for patients who didn’t get a permanent pacemaker.

Drilling down further into the data, Mr. Clancy found that 41% of permanent pacemakers implanted during hospitalization for TAVR went in within 24 hours of the TAVR procedure. In a multivariate regression analysis adjusted for differences in patient demographics, comorbid conditions, and complications, those patients generated an average of $9,843 more in hospital costs than patients who didn’t get a permanent pacemaker during their TAVR hospitalization. However, patients who received a permanent pacemaker more than 24 hours after TAVR cost an average of $17,681 more and had a 2.72-day longer stay than patients who didn’t get a permanent pacemaker.

The need for a permanent pacemaker is a common complication following TAVR. This has been a sticking point for many cardiothoracic surgeons, who note that rates of permanent pacemaker implantation following surgical aortic valve replacement are far lower. Still, rates in TAVR patients have come down over time with advances in valve technology. Currently, permanent pacemaker implantation rates in TAVR patients are 5%-25%, depending upon the valve system, according to Mr. Clancy.

Advances in device design and techniques aimed at reducing the permanent pacemaker implantation rate substantially below the 12% figure seen in 2014 have the potential to generate substantial cost savings, he observed.

Session chair Mohammad Abdelghani, MD, of the Academic Medical Center at Amsterdam questioned whether the study results are relevant to European practice because of the large differences in health care costs.

Discussant Sonia Petronio, MD, expressed a more fundamental reservation.

“This is a very important subject – and a very dangerous one,” said Dr. Petronio of the University of Pisa (Italy). “It’s easier and less costly for a hospital to encourage increasing early permanent pacemaker implantation because the patient can go home earlier.”

“We don’t want to put in a pacemaker earlier to save money,” agreed Dr. Abdelghani. “This is not a cost-effectiveness analysis, it’s purely a cost analysis. Cost-effectiveness would take into account the long-term clinical outcomes and welfare of the patients. We would like to see that from you next year.”

Mr. Clancy is an employee of Edwards Lifesciences, which funded the study.

[email protected]

Coronary artery bypass graft surgery was associated with a 35% lower rate of all-cause mortality rate and a 59% lower rate of cardiac death than was percutaneous coronary intervention in a pooled analysis of nondiabetic patients with multivessel coronary artery disease in two international randomized trials.

“The superiority of CABG over PCI was consistent across all major clinical subgroups. Likewise, the rate of myocardial infarction was remarkably lower after CABG than after PCI,” Mineok Chang, MD, of the University of Ulsan in Seoul, South Korea, and her associates reported online June 27 in the Journal of the American College of Cardiology.

The advent of drug-eluting stents has led to widespread use of PCI, but controversy persists regarding the best revascularization strategy for nondiabetic patients with multivessel CAD, the researchers said. All-cause mortality “is undoubtedly the most unbiased endpoint to determine treatment strategy,” but individual trials have lacked the power to evaluate this endpoint, they added. Accordingly, they pooled data from the SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) trial – which included 1,800 patients with three-vessel or left main CAD from Europe and the United States – and from the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial, which included 880 patients from Asia with two- or three-vessel CAD. Excluding patients with left main CAD or diabetes left 1,275 patients for analysis (J Am Coll Cardiol. 2016 Jun 27. 68:29-36).

After a median follow-up of 61 months, 38 (6%) CABG patients had died, compared with 59 (9.3%) PCI patients, for a statistically significant hazard ratio of 0.65 (95% confidence interval, 0.25-0.78; P = .039). Likewise, cardiac death was significantly less likely after CABG than PCI (HR, 0.41; 95% CI, 0.25-0.78; P = .005). “The statistical difference between the two groups was pronounced after 2 years of randomization for both all-cause and cardiac mortality,” the researchers reported. Although the latest drug-eluting stents “are reported to improve clinical outcomes,” they did not find a significant interaction between older and more recently developed stents when considering all-cause mortality, they noted.

The study was supported by a research grant from the CardioVascular Research Foundation in Seoul, South Korea. Dr. Chang had no disclosures. Senior author, Dr. Seung-Jung Park, disclosed research support from Abbott Vascular, Cordis, Boston Scientific, and Medtronic.

Coronary artery bypass graft surgery was associated with a 35% lower rate of all-cause mortality rate and a 59% lower rate of cardiac death than was percutaneous coronary intervention in a pooled analysis of nondiabetic patients with multivessel coronary artery disease in two international randomized trials.

“The superiority of CABG over PCI was consistent across all major clinical subgroups. Likewise, the rate of myocardial infarction was remarkably lower after CABG than after PCI,” Mineok Chang, MD, of the University of Ulsan in Seoul, South Korea, and her associates reported online June 27 in the Journal of the American College of Cardiology.

The advent of drug-eluting stents has led to widespread use of PCI, but controversy persists regarding the best revascularization strategy for nondiabetic patients with multivessel CAD, the researchers said. All-cause mortality “is undoubtedly the most unbiased endpoint to determine treatment strategy,” but individual trials have lacked the power to evaluate this endpoint, they added. Accordingly, they pooled data from the SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) trial – which included 1,800 patients with three-vessel or left main CAD from Europe and the United States – and from the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial, which included 880 patients from Asia with two- or three-vessel CAD. Excluding patients with left main CAD or diabetes left 1,275 patients for analysis (J Am Coll Cardiol. 2016 Jun 27. 68:29-36).

After a median follow-up of 61 months, 38 (6%) CABG patients had died, compared with 59 (9.3%) PCI patients, for a statistically significant hazard ratio of 0.65 (95% confidence interval, 0.25-0.78; P = .039). Likewise, cardiac death was significantly less likely after CABG than PCI (HR, 0.41; 95% CI, 0.25-0.78; P = .005). “The statistical difference between the two groups was pronounced after 2 years of randomization for both all-cause and cardiac mortality,” the researchers reported. Although the latest drug-eluting stents “are reported to improve clinical outcomes,” they did not find a significant interaction between older and more recently developed stents when considering all-cause mortality, they noted.

The study was supported by a research grant from the CardioVascular Research Foundation in Seoul, South Korea. Dr. Chang had no disclosures. Senior author, Dr. Seung-Jung Park, disclosed research support from Abbott Vascular, Cordis, Boston Scientific, and Medtronic.

Coronary artery bypass graft surgery was associated with a 35% lower rate of all-cause mortality rate and a 59% lower rate of cardiac death than was percutaneous coronary intervention in a pooled analysis of nondiabetic patients with multivessel coronary artery disease in two international randomized trials.

“The superiority of CABG over PCI was consistent across all major clinical subgroups. Likewise, the rate of myocardial infarction was remarkably lower after CABG than after PCI,” Mineok Chang, MD, of the University of Ulsan in Seoul, South Korea, and her associates reported online June 27 in the Journal of the American College of Cardiology.

The advent of drug-eluting stents has led to widespread use of PCI, but controversy persists regarding the best revascularization strategy for nondiabetic patients with multivessel CAD, the researchers said. All-cause mortality “is undoubtedly the most unbiased endpoint to determine treatment strategy,” but individual trials have lacked the power to evaluate this endpoint, they added. Accordingly, they pooled data from the SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) trial – which included 1,800 patients with three-vessel or left main CAD from Europe and the United States – and from the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial, which included 880 patients from Asia with two- or three-vessel CAD. Excluding patients with left main CAD or diabetes left 1,275 patients for analysis (J Am Coll Cardiol. 2016 Jun 27. 68:29-36).

After a median follow-up of 61 months, 38 (6%) CABG patients had died, compared with 59 (9.3%) PCI patients, for a statistically significant hazard ratio of 0.65 (95% confidence interval, 0.25-0.78; P = .039). Likewise, cardiac death was significantly less likely after CABG than PCI (HR, 0.41; 95% CI, 0.25-0.78; P = .005). “The statistical difference between the two groups was pronounced after 2 years of randomization for both all-cause and cardiac mortality,” the researchers reported. Although the latest drug-eluting stents “are reported to improve clinical outcomes,” they did not find a significant interaction between older and more recently developed stents when considering all-cause mortality, they noted.

The study was supported by a research grant from the CardioVascular Research Foundation in Seoul, South Korea. Dr. Chang had no disclosures. Senior author, Dr. Seung-Jung Park, disclosed research support from Abbott Vascular, Cordis, Boston Scientific, and Medtronic.

Premenopausal risk-reducing salpingo-oophorectomy becomes cost-effective in women who have a 4% or greater lifetime risk of ovarian cancer, according to a modeling study published online in the Journal of Medical Genetics.

The procedure, which is usually undertaken in women aged over 35 years who have completed their families, is available in the United Kingdom to women with a greater than 10% lifetime risk of ovarian cancer. However, the researchers, led by Dr. Ranjit Manchanda of Barts Cancer Institute at Queen Mary University of London, suggested that this threshold has not been tested for cost-effectiveness.

The decision analysis model evaluated lifetime costs as well as the effects of risk-reducing salpingo-oophorectomy in 40-year-old premenopausal women by comparing it with no procedure in women whose lifetime ovarian cancer risk ranged from 2%-10%. The final outcomes were development of breast cancer, ovarian cancer, and excess deaths from coronary heart disease, while cost-effectiveness was judged against the National Institute for Health and Care Excellence threshold of £20,000-£30,000 per quality-adjusted life-years (QALY).

Researchers found that premenopausal risk-reducing salpingo-oophorectomy was cost-effective in women with a 4% or greater lifetime risk of ovarian cancer, largely because of the reduction in their risk of breast cancer. At this level of risk, surgery gained 42.7 days of life-expectancy, with an incremental cost-effectiveness ratio of £19,536($26,186)/QALY.

Premenopausal risk-reducing salpingo-oophorectomy was not cost-effective at the baseline risk rate of 2%, with an incremental cost-effectiveness ratio of £46,480($62,267)/QALY and 19.9 days gain in life expectancy (J Med Genetics 2016 June 27. doi: 10.1136/jmedgenet-2016-103800).

The cost-effectiveness was predicated on the assumption of at least an 80% compliance rate with hormone therapy (HT) in women who underwent the procedure; without HT, the cost-effectiveness threshold increased to a lifetime risk of over 8.2%.

“Our results are of major significance for clinical practice and risk management in view of declining genetic testing costs and the improvements in estimating an individual’s OC risk,” the authors wrote.

“With routine clinical testing for certain moderate penetrance genes around the corner and lack of an effective OC screening programme, these findings are timely as it provides evidence supporting a surgical prevention strategy for ‘lower-risk’ (lifetime risk less than 10%) individuals,” noted Dr. Manchanda and colleagues.

They stressed that symptom levels after salpingo-oophorectomy, particularly for sexual function, were still higher even in women taking HT compared to those who hadn’t undergone salpingo-oophorectomy.

“This limitation needs to be discussed as part of informed consent for the surgical procedure and incorporated into [the risk-reducing salpingo-oophorectomy] decision-making process,” they wrote.

One author declared a financial interest in Abcodia, which has an interest in ovarian cancer screening and biomarkers for screening and risk prediction. No other conflicts of interest were declared.

Premenopausal risk-reducing salpingo-oophorectomy becomes cost-effective in women who have a 4% or greater lifetime risk of ovarian cancer, according to a modeling study published online in the Journal of Medical Genetics.

The procedure, which is usually undertaken in women aged over 35 years who have completed their families, is available in the United Kingdom to women with a greater than 10% lifetime risk of ovarian cancer. However, the researchers, led by Dr. Ranjit Manchanda of Barts Cancer Institute at Queen Mary University of London, suggested that this threshold has not been tested for cost-effectiveness.

The decision analysis model evaluated lifetime costs as well as the effects of risk-reducing salpingo-oophorectomy in 40-year-old premenopausal women by comparing it with no procedure in women whose lifetime ovarian cancer risk ranged from 2%-10%. The final outcomes were development of breast cancer, ovarian cancer, and excess deaths from coronary heart disease, while cost-effectiveness was judged against the National Institute for Health and Care Excellence threshold of £20,000-£30,000 per quality-adjusted life-years (QALY).

Researchers found that premenopausal risk-reducing salpingo-oophorectomy was cost-effective in women with a 4% or greater lifetime risk of ovarian cancer, largely because of the reduction in their risk of breast cancer. At this level of risk, surgery gained 42.7 days of life-expectancy, with an incremental cost-effectiveness ratio of £19,536($26,186)/QALY.

Premenopausal risk-reducing salpingo-oophorectomy was not cost-effective at the baseline risk rate of 2%, with an incremental cost-effectiveness ratio of £46,480($62,267)/QALY and 19.9 days gain in life expectancy (J Med Genetics 2016 June 27. doi: 10.1136/jmedgenet-2016-103800).

The cost-effectiveness was predicated on the assumption of at least an 80% compliance rate with hormone therapy (HT) in women who underwent the procedure; without HT, the cost-effectiveness threshold increased to a lifetime risk of over 8.2%.

“Our results are of major significance for clinical practice and risk management in view of declining genetic testing costs and the improvements in estimating an individual’s OC risk,” the authors wrote.

“With routine clinical testing for certain moderate penetrance genes around the corner and lack of an effective OC screening programme, these findings are timely as it provides evidence supporting a surgical prevention strategy for ‘lower-risk’ (lifetime risk less than 10%) individuals,” noted Dr. Manchanda and colleagues.

They stressed that symptom levels after salpingo-oophorectomy, particularly for sexual function, were still higher even in women taking HT compared to those who hadn’t undergone salpingo-oophorectomy.

“This limitation needs to be discussed as part of informed consent for the surgical procedure and incorporated into [the risk-reducing salpingo-oophorectomy] decision-making process,” they wrote.

One author declared a financial interest in Abcodia, which has an interest in ovarian cancer screening and biomarkers for screening and risk prediction. No other conflicts of interest were declared.

Premenopausal risk-reducing salpingo-oophorectomy becomes cost-effective in women who have a 4% or greater lifetime risk of ovarian cancer, according to a modeling study published online in the Journal of Medical Genetics.

The procedure, which is usually undertaken in women aged over 35 years who have completed their families, is available in the United Kingdom to women with a greater than 10% lifetime risk of ovarian cancer. However, the researchers, led by Dr. Ranjit Manchanda of Barts Cancer Institute at Queen Mary University of London, suggested that this threshold has not been tested for cost-effectiveness.

The decision analysis model evaluated lifetime costs as well as the effects of risk-reducing salpingo-oophorectomy in 40-year-old premenopausal women by comparing it with no procedure in women whose lifetime ovarian cancer risk ranged from 2%-10%. The final outcomes were development of breast cancer, ovarian cancer, and excess deaths from coronary heart disease, while cost-effectiveness was judged against the National Institute for Health and Care Excellence threshold of £20,000-£30,000 per quality-adjusted life-years (QALY).

Researchers found that premenopausal risk-reducing salpingo-oophorectomy was cost-effective in women with a 4% or greater lifetime risk of ovarian cancer, largely because of the reduction in their risk of breast cancer. At this level of risk, surgery gained 42.7 days of life-expectancy, with an incremental cost-effectiveness ratio of £19,536($26,186)/QALY.

Premenopausal risk-reducing salpingo-oophorectomy was not cost-effective at the baseline risk rate of 2%, with an incremental cost-effectiveness ratio of £46,480($62,267)/QALY and 19.9 days gain in life expectancy (J Med Genetics 2016 June 27. doi: 10.1136/jmedgenet-2016-103800).

The cost-effectiveness was predicated on the assumption of at least an 80% compliance rate with hormone therapy (HT) in women who underwent the procedure; without HT, the cost-effectiveness threshold increased to a lifetime risk of over 8.2%.

“Our results are of major significance for clinical practice and risk management in view of declining genetic testing costs and the improvements in estimating an individual’s OC risk,” the authors wrote.

“With routine clinical testing for certain moderate penetrance genes around the corner and lack of an effective OC screening programme, these findings are timely as it provides evidence supporting a surgical prevention strategy for ‘lower-risk’ (lifetime risk less than 10%) individuals,” noted Dr. Manchanda and colleagues.

They stressed that symptom levels after salpingo-oophorectomy, particularly for sexual function, were still higher even in women taking HT compared to those who hadn’t undergone salpingo-oophorectomy.

“This limitation needs to be discussed as part of informed consent for the surgical procedure and incorporated into [the risk-reducing salpingo-oophorectomy] decision-making process,” they wrote.

One author declared a financial interest in Abcodia, which has an interest in ovarian cancer screening and biomarkers for screening and risk prediction. No other conflicts of interest were declared.

DENVER – The surgically implanted Inspire system for controlled upper airway stimulation as therapy for moderate to severe obstructive sleep apnea demonstrated sustained benefit at 42 months of prospective follow-up in the STAR trial, Dr. Patrick J. Strollo Jr. reported at the annual meeting of the Associated Professional Sleep Societies.

STAR was the pivotal trial whose previously reported 12-month outcomes led to Food and Drug Administration clearance of the device. Dr. Strollo was first author of that paper (N Engl J Med. 2014 Jan 9;370:139-49). At SLEEP 2016, he presented patient- and partner-reported outcomes at 42 months. Bottom line: The device had continued safety and no loss in efficacy.

“So far it seems to be a useful option for people who frequently didn’t have an option. And the technology is improving and will only get better,” said Dr. Strollo, professor of medicine and clinical and translational science, director of the Sleep Medicine Center, and codirector of the Sleep Medicine Institute at the University of Pittsburgh.

The Inspire system consists of three parts implanted by an otolaryngologist in an outpatient procedure: a small impulse generator, a breathing sensor lead inserted in the intercostal muscle, and a stimulator lead attached to the distal branch of the 10th cranial nerve, the hypoglossal nerve controlling the tongue muscles.

The device is programmed to discharge at the end of expiration and continue through the inspiratory phase, causing the tongue to move forward and the retrolingual and retropalatal airways to open, he explained in an interview.

Upper airway stimulation is approved for commercial use in patients such as those enrolled in the STAR trial on the basis of pilot studies that identified most likely responders. The key selection criteria include moderate to severe obstructive sleep apnea as defined by an apnea-hypopnea index of 20-50, nonadherence to continuous positive airway pressure (CPAP), a body mass index of 32 kg/m² or less, and absence of concentric collapse of the airway at the level of the palate during sedated endoscopy.

STAR included 126 participants who received the upper airway stimulation device. There have been two explants: one from septic arthritis, the other elective.

A total of 97 STAR participants had 42-month follow-up data available. Among the key findings were that:

• Mean scores on the Epworth Sleepiness Scale decreased from 11.6 at baseline to 7 at 12 months and 7.1 at 42 months.

• Scores on the Functional Outcomes of Sleep Questionnaire improved from 14.3 at baseline to 17.3 at 12 months and 17.5 at 42 months.

• The scores on both the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire were abnormal at baseline and converted to normal range at both 12 and 42 months of follow-up.

• At baseline, 29% of the patients’ sleeping partners characterized the snoring as loud, 24% rated it ‘very intense,’ and 30% left the bedroom. At 32 months, 11% of partners called the snoring loud, 3% deemed it very intense, and only 4% left the room.

• At 42 months, 81% of patients reported using the device nightly. That’s consistent with the objective evidence of adherence Dr. Strollo and his coinvestigators obtained in a study of postmarketing device implants in which they found device usage averaged about 7 hours per night.

“That’s much better than we see with CPAP in patients who can tolerate that therapy,” Dr. Strollo observed.

The planned 5-year follow-up of STAR participants includes a full laboratory polysomnography study to obtain objective apnea-hypopnea index figures.

The other major development is the launch of a comprehensive registry of patients who receive a post-marketing commercial implant. Roughly 1,000 implants have been done worldwide to date, but now that the device is approved, that number will quickly grow. The registry should prove a rich source for research.

“The goal is to try to refine the selection criteria,” according to Dr. Strollo.

Given that only about 50% of patients with moderate to severe sleep apnea are able to tolerate CPAP long term, where does the Inspire system fit into today’s practice of sleep medicine?

“Upper airway stimulation is another tool, another option for patients,” he said. “In my practice, normally I’d let patients try positive pressure first. I want to make sure they’ve tried CPAP, and they’ve tried more advanced therapy like autotitrating bilevel positive airway pressure, which is more comfortable than CPAP. Bilevel positive airway pressure allows you to salvage a fair number of patients who can’t tolerate CPAP. And I also offer an oral appliance, although the robustness of an oral appliance is not great as apnea becomes more severe.”

The STAR trial is supported by Inspire Medical Systems. Dr. Strollo reported receiving a research grant from the company.

[email protected]

DENVER – The surgically implanted Inspire system for controlled upper airway stimulation as therapy for moderate to severe obstructive sleep apnea demonstrated sustained benefit at 42 months of prospective follow-up in the STAR trial, Dr. Patrick J. Strollo Jr. reported at the annual meeting of the Associated Professional Sleep Societies.

STAR was the pivotal trial whose previously reported 12-month outcomes led to Food and Drug Administration clearance of the device. Dr. Strollo was first author of that paper (N Engl J Med. 2014 Jan 9;370:139-49). At SLEEP 2016, he presented patient- and partner-reported outcomes at 42 months. Bottom line: The device had continued safety and no loss in efficacy.

“So far it seems to be a useful option for people who frequently didn’t have an option. And the technology is improving and will only get better,” said Dr. Strollo, professor of medicine and clinical and translational science, director of the Sleep Medicine Center, and codirector of the Sleep Medicine Institute at the University of Pittsburgh.

The Inspire system consists of three parts implanted by an otolaryngologist in an outpatient procedure: a small impulse generator, a breathing sensor lead inserted in the intercostal muscle, and a stimulator lead attached to the distal branch of the 10th cranial nerve, the hypoglossal nerve controlling the tongue muscles.

The device is programmed to discharge at the end of expiration and continue through the inspiratory phase, causing the tongue to move forward and the retrolingual and retropalatal airways to open, he explained in an interview.

Upper airway stimulation is approved for commercial use in patients such as those enrolled in the STAR trial on the basis of pilot studies that identified most likely responders. The key selection criteria include moderate to severe obstructive sleep apnea as defined by an apnea-hypopnea index of 20-50, nonadherence to continuous positive airway pressure (CPAP), a body mass index of 32 kg/m² or less, and absence of concentric collapse of the airway at the level of the palate during sedated endoscopy.

STAR included 126 participants who received the upper airway stimulation device. There have been two explants: one from septic arthritis, the other elective.

A total of 97 STAR participants had 42-month follow-up data available. Among the key findings were that:

• Mean scores on the Epworth Sleepiness Scale decreased from 11.6 at baseline to 7 at 12 months and 7.1 at 42 months.

• Scores on the Functional Outcomes of Sleep Questionnaire improved from 14.3 at baseline to 17.3 at 12 months and 17.5 at 42 months.

• The scores on both the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire were abnormal at baseline and converted to normal range at both 12 and 42 months of follow-up.

• At baseline, 29% of the patients’ sleeping partners characterized the snoring as loud, 24% rated it ‘very intense,’ and 30% left the bedroom. At 32 months, 11% of partners called the snoring loud, 3% deemed it very intense, and only 4% left the room.

• At 42 months, 81% of patients reported using the device nightly. That’s consistent with the objective evidence of adherence Dr. Strollo and his coinvestigators obtained in a study of postmarketing device implants in which they found device usage averaged about 7 hours per night.

“That’s much better than we see with CPAP in patients who can tolerate that therapy,” Dr. Strollo observed.

The planned 5-year follow-up of STAR participants includes a full laboratory polysomnography study to obtain objective apnea-hypopnea index figures.

The other major development is the launch of a comprehensive registry of patients who receive a post-marketing commercial implant. Roughly 1,000 implants have been done worldwide to date, but now that the device is approved, that number will quickly grow. The registry should prove a rich source for research.

“The goal is to try to refine the selection criteria,” according to Dr. Strollo.

Given that only about 50% of patients with moderate to severe sleep apnea are able to tolerate CPAP long term, where does the Inspire system fit into today’s practice of sleep medicine?

“Upper airway stimulation is another tool, another option for patients,” he said. “In my practice, normally I’d let patients try positive pressure first. I want to make sure they’ve tried CPAP, and they’ve tried more advanced therapy like autotitrating bilevel positive airway pressure, which is more comfortable than CPAP. Bilevel positive airway pressure allows you to salvage a fair number of patients who can’t tolerate CPAP. And I also offer an oral appliance, although the robustness of an oral appliance is not great as apnea becomes more severe.”

The STAR trial is supported by Inspire Medical Systems. Dr. Strollo reported receiving a research grant from the company.

[email protected]

DENVER – The surgically implanted Inspire system for controlled upper airway stimulation as therapy for moderate to severe obstructive sleep apnea demonstrated sustained benefit at 42 months of prospective follow-up in the STAR trial, Dr. Patrick J. Strollo Jr. reported at the annual meeting of the Associated Professional Sleep Societies.

STAR was the pivotal trial whose previously reported 12-month outcomes led to Food and Drug Administration clearance of the device. Dr. Strollo was first author of that paper (N Engl J Med. 2014 Jan 9;370:139-49). At SLEEP 2016, he presented patient- and partner-reported outcomes at 42 months. Bottom line: The device had continued safety and no loss in efficacy.

“So far it seems to be a useful option for people who frequently didn’t have an option. And the technology is improving and will only get better,” said Dr. Strollo, professor of medicine and clinical and translational science, director of the Sleep Medicine Center, and codirector of the Sleep Medicine Institute at the University of Pittsburgh.

The Inspire system consists of three parts implanted by an otolaryngologist in an outpatient procedure: a small impulse generator, a breathing sensor lead inserted in the intercostal muscle, and a stimulator lead attached to the distal branch of the 10th cranial nerve, the hypoglossal nerve controlling the tongue muscles.

The device is programmed to discharge at the end of expiration and continue through the inspiratory phase, causing the tongue to move forward and the retrolingual and retropalatal airways to open, he explained in an interview.

Upper airway stimulation is approved for commercial use in patients such as those enrolled in the STAR trial on the basis of pilot studies that identified most likely responders. The key selection criteria include moderate to severe obstructive sleep apnea as defined by an apnea-hypopnea index of 20-50, nonadherence to continuous positive airway pressure (CPAP), a body mass index of 32 kg/m² or less, and absence of concentric collapse of the airway at the level of the palate during sedated endoscopy.

STAR included 126 participants who received the upper airway stimulation device. There have been two explants: one from septic arthritis, the other elective.

A total of 97 STAR participants had 42-month follow-up data available. Among the key findings were that:

• Mean scores on the Epworth Sleepiness Scale decreased from 11.6 at baseline to 7 at 12 months and 7.1 at 42 months.

• Scores on the Functional Outcomes of Sleep Questionnaire improved from 14.3 at baseline to 17.3 at 12 months and 17.5 at 42 months.

• The scores on both the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire were abnormal at baseline and converted to normal range at both 12 and 42 months of follow-up.

• At baseline, 29% of the patients’ sleeping partners characterized the snoring as loud, 24% rated it ‘very intense,’ and 30% left the bedroom. At 32 months, 11% of partners called the snoring loud, 3% deemed it very intense, and only 4% left the room.

• At 42 months, 81% of patients reported using the device nightly. That’s consistent with the objective evidence of adherence Dr. Strollo and his coinvestigators obtained in a study of postmarketing device implants in which they found device usage averaged about 7 hours per night.

“That’s much better than we see with CPAP in patients who can tolerate that therapy,” Dr. Strollo observed.

The planned 5-year follow-up of STAR participants includes a full laboratory polysomnography study to obtain objective apnea-hypopnea index figures.

The other major development is the launch of a comprehensive registry of patients who receive a post-marketing commercial implant. Roughly 1,000 implants have been done worldwide to date, but now that the device is approved, that number will quickly grow. The registry should prove a rich source for research.

“The goal is to try to refine the selection criteria,” according to Dr. Strollo.

Given that only about 50% of patients with moderate to severe sleep apnea are able to tolerate CPAP long term, where does the Inspire system fit into today’s practice of sleep medicine?

“Upper airway stimulation is another tool, another option for patients,” he said. “In my practice, normally I’d let patients try positive pressure first. I want to make sure they’ve tried CPAP, and they’ve tried more advanced therapy like autotitrating bilevel positive airway pressure, which is more comfortable than CPAP. Bilevel positive airway pressure allows you to salvage a fair number of patients who can’t tolerate CPAP. And I also offer an oral appliance, although the robustness of an oral appliance is not great as apnea becomes more severe.”

The STAR trial is supported by Inspire Medical Systems. Dr. Strollo reported receiving a research grant from the company.

[email protected]

SAN FRANCISCO – Hospitalized patients who have a change in the medical residents responsible for their care are more likely to die, finds a retrospective cohort study of roughly a quarter million discharges from Veterans Affairs medical centers.

A monthly change in resident care was associated with 9%-20% higher adjusted odds of death during the hospital stay and after discharge, investigators reported in a poster discussion session and press briefing at an international conference of the American Thoracic Society. Analyses suggested that such transitions accounted for 718 additional deaths in the hospital alone during the 6-year study period.

“These are very strong findings,” said Dr. Joshua L. Denson, a fellow in the divisions of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The study results represent an important initial step in bringing the problem to light, he said. “Handoffs shift to shift have been looked at, but not this end-of-month, more permanent switching, which I think is a much more substantial transition in care.”

The factors driving the increased mortality are unclear, according to Dr. Denson; however, “when you go on to a new service [as a resident] ... you are now responsible for 20 new people all of a sudden that night.” Therefore, these transitions can be a hectic time characterized by reduced communication and inefficient discharges. In addition, the incoming residents lack familiarity with their new patients’ particulars.

“The handoffs are definitely not preventable, so this is something that has to be dealt with,” he maintained. The study’s findings hint at several possible areas for improvement.

None of the 10 residency programs surveyed provided formal education for monthly resident handoffs, focusing instead on handoffs at shift changes, and most programs lacked a standard procedure, with just one requiring that the handoff be done in person. The programs also varied greatly in their staggering of handoffs – separating transitions of interns (first-year residents) and higher-level residents by at least a few days – to minimize impact.

Despite the absence of outcomes data in this area, some hospitals are forging ahead with their own interventions intended to smooth care transitions, Dr. Denson reported. “In at least two hospitals that I’ve worked in, they are implementing what is called a warm handoff,” he explained. “Basically, a resident from the prior rotation comes the next day and rounds with the new team so he can tell them, ‘Oh, this guy looks a little worse today, you may want to watch him,’ or ‘He looks a little better.’ ”

In the study, conducted while Dr. Denson was chief resident at the NYU School of Medicine, he and his colleagues analyzed data from 10 university-affiliated Veterans Affairs hospitals and internal medicine residency programs that provided their residents’ schedules. Analyses were based on a total of 230,701 discharges of adult medical patients between July 2008 and June 2014.

Hospitalized patients were categorized as having a transition in resident care if they were admitted before the date of an end-of-month house staff transition in care and were discharged in the week after it.

In unadjusted analyses, patients who had a transition of care – whether of intern only, resident only, or both – had significantly higher odds of inpatient mortality and of 30-day mortality and 90-day postdischarge mortality, compared with counterparts who did not have the corresponding transition of care.

In adjusted analyses, patients who had an intern transition still had higher odds of in-hospital mortality (odds ratio, 1.14). In addition, patients had persistently elevated odds of 30-day mortality and 90-day postdischarge mortality if they had an intern transition (odds ratios, 1.20 and 1.17, respectively), a resident transition (1.15 and 1.14), or both (1.10 and 1.09).

The findings “suggest possibly a level-of-training effect to these transitions, as it’s the most inexperienced people that have the higher rate of mortality,” noted Dr. Denson, who disclosed that he had no relevant conflicts of interest. “Interns, being the first-years, tend to carry the bulk of the work in most hospitals, which is an interesting paradigm in our organization. And that may be a good explanation for why we are seeing this.”

SAN FRANCISCO – Hospitalized patients who have a change in the medical residents responsible for their care are more likely to die, finds a retrospective cohort study of roughly a quarter million discharges from Veterans Affairs medical centers.

A monthly change in resident care was associated with 9%-20% higher adjusted odds of death during the hospital stay and after discharge, investigators reported in a poster discussion session and press briefing at an international conference of the American Thoracic Society. Analyses suggested that such transitions accounted for 718 additional deaths in the hospital alone during the 6-year study period.

“These are very strong findings,” said Dr. Joshua L. Denson, a fellow in the divisions of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The study results represent an important initial step in bringing the problem to light, he said. “Handoffs shift to shift have been looked at, but not this end-of-month, more permanent switching, which I think is a much more substantial transition in care.”

The factors driving the increased mortality are unclear, according to Dr. Denson; however, “when you go on to a new service [as a resident] ... you are now responsible for 20 new people all of a sudden that night.” Therefore, these transitions can be a hectic time characterized by reduced communication and inefficient discharges. In addition, the incoming residents lack familiarity with their new patients’ particulars.

“The handoffs are definitely not preventable, so this is something that has to be dealt with,” he maintained. The study’s findings hint at several possible areas for improvement.

None of the 10 residency programs surveyed provided formal education for monthly resident handoffs, focusing instead on handoffs at shift changes, and most programs lacked a standard procedure, with just one requiring that the handoff be done in person. The programs also varied greatly in their staggering of handoffs – separating transitions of interns (first-year residents) and higher-level residents by at least a few days – to minimize impact.

Despite the absence of outcomes data in this area, some hospitals are forging ahead with their own interventions intended to smooth care transitions, Dr. Denson reported. “In at least two hospitals that I’ve worked in, they are implementing what is called a warm handoff,” he explained. “Basically, a resident from the prior rotation comes the next day and rounds with the new team so he can tell them, ‘Oh, this guy looks a little worse today, you may want to watch him,’ or ‘He looks a little better.’ ”

In the study, conducted while Dr. Denson was chief resident at the NYU School of Medicine, he and his colleagues analyzed data from 10 university-affiliated Veterans Affairs hospitals and internal medicine residency programs that provided their residents’ schedules. Analyses were based on a total of 230,701 discharges of adult medical patients between July 2008 and June 2014.

Hospitalized patients were categorized as having a transition in resident care if they were admitted before the date of an end-of-month house staff transition in care and were discharged in the week after it.

In unadjusted analyses, patients who had a transition of care – whether of intern only, resident only, or both – had significantly higher odds of inpatient mortality and of 30-day mortality and 90-day postdischarge mortality, compared with counterparts who did not have the corresponding transition of care.

In adjusted analyses, patients who had an intern transition still had higher odds of in-hospital mortality (odds ratio, 1.14). In addition, patients had persistently elevated odds of 30-day mortality and 90-day postdischarge mortality if they had an intern transition (odds ratios, 1.20 and 1.17, respectively), a resident transition (1.15 and 1.14), or both (1.10 and 1.09).

The findings “suggest possibly a level-of-training effect to these transitions, as it’s the most inexperienced people that have the higher rate of mortality,” noted Dr. Denson, who disclosed that he had no relevant conflicts of interest. “Interns, being the first-years, tend to carry the bulk of the work in most hospitals, which is an interesting paradigm in our organization. And that may be a good explanation for why we are seeing this.”

SAN FRANCISCO – Hospitalized patients who have a change in the medical residents responsible for their care are more likely to die, finds a retrospective cohort study of roughly a quarter million discharges from Veterans Affairs medical centers.

A monthly change in resident care was associated with 9%-20% higher adjusted odds of death during the hospital stay and after discharge, investigators reported in a poster discussion session and press briefing at an international conference of the American Thoracic Society. Analyses suggested that such transitions accounted for 718 additional deaths in the hospital alone during the 6-year study period.

“These are very strong findings,” said Dr. Joshua L. Denson, a fellow in the divisions of pulmonary sciences and critical care medicine at the University of Colorado, Aurora.

The study results represent an important initial step in bringing the problem to light, he said. “Handoffs shift to shift have been looked at, but not this end-of-month, more permanent switching, which I think is a much more substantial transition in care.”

The factors driving the increased mortality are unclear, according to Dr. Denson; however, “when you go on to a new service [as a resident] ... you are now responsible for 20 new people all of a sudden that night.” Therefore, these transitions can be a hectic time characterized by reduced communication and inefficient discharges. In addition, the incoming residents lack familiarity with their new patients’ particulars.

“The handoffs are definitely not preventable, so this is something that has to be dealt with,” he maintained. The study’s findings hint at several possible areas for improvement.

None of the 10 residency programs surveyed provided formal education for monthly resident handoffs, focusing instead on handoffs at shift changes, and most programs lacked a standard procedure, with just one requiring that the handoff be done in person. The programs also varied greatly in their staggering of handoffs – separating transitions of interns (first-year residents) and higher-level residents by at least a few days – to minimize impact.

Despite the absence of outcomes data in this area, some hospitals are forging ahead with their own interventions intended to smooth care transitions, Dr. Denson reported. “In at least two hospitals that I’ve worked in, they are implementing what is called a warm handoff,” he explained. “Basically, a resident from the prior rotation comes the next day and rounds with the new team so he can tell them, ‘Oh, this guy looks a little worse today, you may want to watch him,’ or ‘He looks a little better.’ ”

In the study, conducted while Dr. Denson was chief resident at the NYU School of Medicine, he and his colleagues analyzed data from 10 university-affiliated Veterans Affairs hospitals and internal medicine residency programs that provided their residents’ schedules. Analyses were based on a total of 230,701 discharges of adult medical patients between July 2008 and June 2014.

Hospitalized patients were categorized as having a transition in resident care if they were admitted before the date of an end-of-month house staff transition in care and were discharged in the week after it.

In unadjusted analyses, patients who had a transition of care – whether of intern only, resident only, or both – had significantly higher odds of inpatient mortality and of 30-day mortality and 90-day postdischarge mortality, compared with counterparts who did not have the corresponding transition of care.

In adjusted analyses, patients who had an intern transition still had higher odds of in-hospital mortality (odds ratio, 1.14). In addition, patients had persistently elevated odds of 30-day mortality and 90-day postdischarge mortality if they had an intern transition (odds ratios, 1.20 and 1.17, respectively), a resident transition (1.15 and 1.14), or both (1.10 and 1.09).

The findings “suggest possibly a level-of-training effect to these transitions, as it’s the most inexperienced people that have the higher rate of mortality,” noted Dr. Denson, who disclosed that he had no relevant conflicts of interest. “Interns, being the first-years, tend to carry the bulk of the work in most hospitals, which is an interesting paradigm in our organization. And that may be a good explanation for why we are seeing this.”