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Surgical Safety Training Program Can Foster Increased Vigilance
A training program modeled on airline industry initiatives can change behavior and cultivate a culture of safety in the operating room, based on data from a survey and follow-up study.
Such training increased acceptance of perioperative checklists, led to more self-reporting of “unsafe conditions and near misses,” and enhanced empowerment in two medical facilities.
“The introduction of CRM [crew resource management] training, combined with other initiatives, enhances personal commitment to patient safety and appears to alter behaviors relative to checklist use and self-reporting,” reported Dr. Harry C. Sax of the department of surgery at Brown University and the Miriam Hospital, both in Providence, R.I., and his colleagues (Arch. Surg. 2009;144:1133–7).
They reported the results of a CRM program begun at the University of Rochester (N.Y.) Strong Medical Center in 2003, and at Brown University's Miriam Hospital in 2005. Of the 858 participants, half were nurses, 28% ancillary personnel, and 22% physicians.
A 10-item perioperative checklist “modeled on preflight aviation checklists,” was posted in each operating room. It listed all participants and required signoffs from two team members regarding items such as surgical site and side verifications, use of perioperative antibiotics, deep vein thrombosis prophylaxis, and beta-blockade, Dr. Sax and his colleagues wrote. A survey that measured attitudes toward safety was given immediately before and after training, and again at least 2 months later.
The study found that “consistent checklist use rose from 75% in 2002 to 100% in 2007 and beyond,” and “self-reporting of incidents rose from 709 per quarter in 2002 to 1,481 per quarter in 2008.”
Disclosures: Dr. Sax serves as a medical consultant to Indelta Learning Systems Inc., which codeveloped the CRM training; one coauthor is an Indelta employee.
A training program modeled on airline industry initiatives can change behavior and cultivate a culture of safety in the operating room, based on data from a survey and follow-up study.
Such training increased acceptance of perioperative checklists, led to more self-reporting of “unsafe conditions and near misses,” and enhanced empowerment in two medical facilities.
“The introduction of CRM [crew resource management] training, combined with other initiatives, enhances personal commitment to patient safety and appears to alter behaviors relative to checklist use and self-reporting,” reported Dr. Harry C. Sax of the department of surgery at Brown University and the Miriam Hospital, both in Providence, R.I., and his colleagues (Arch. Surg. 2009;144:1133–7).
They reported the results of a CRM program begun at the University of Rochester (N.Y.) Strong Medical Center in 2003, and at Brown University's Miriam Hospital in 2005. Of the 858 participants, half were nurses, 28% ancillary personnel, and 22% physicians.
A 10-item perioperative checklist “modeled on preflight aviation checklists,” was posted in each operating room. It listed all participants and required signoffs from two team members regarding items such as surgical site and side verifications, use of perioperative antibiotics, deep vein thrombosis prophylaxis, and beta-blockade, Dr. Sax and his colleagues wrote. A survey that measured attitudes toward safety was given immediately before and after training, and again at least 2 months later.
The study found that “consistent checklist use rose from 75% in 2002 to 100% in 2007 and beyond,” and “self-reporting of incidents rose from 709 per quarter in 2002 to 1,481 per quarter in 2008.”
Disclosures: Dr. Sax serves as a medical consultant to Indelta Learning Systems Inc., which codeveloped the CRM training; one coauthor is an Indelta employee.
A training program modeled on airline industry initiatives can change behavior and cultivate a culture of safety in the operating room, based on data from a survey and follow-up study.
Such training increased acceptance of perioperative checklists, led to more self-reporting of “unsafe conditions and near misses,” and enhanced empowerment in two medical facilities.
“The introduction of CRM [crew resource management] training, combined with other initiatives, enhances personal commitment to patient safety and appears to alter behaviors relative to checklist use and self-reporting,” reported Dr. Harry C. Sax of the department of surgery at Brown University and the Miriam Hospital, both in Providence, R.I., and his colleagues (Arch. Surg. 2009;144:1133–7).
They reported the results of a CRM program begun at the University of Rochester (N.Y.) Strong Medical Center in 2003, and at Brown University's Miriam Hospital in 2005. Of the 858 participants, half were nurses, 28% ancillary personnel, and 22% physicians.
A 10-item perioperative checklist “modeled on preflight aviation checklists,” was posted in each operating room. It listed all participants and required signoffs from two team members regarding items such as surgical site and side verifications, use of perioperative antibiotics, deep vein thrombosis prophylaxis, and beta-blockade, Dr. Sax and his colleagues wrote. A survey that measured attitudes toward safety was given immediately before and after training, and again at least 2 months later.
The study found that “consistent checklist use rose from 75% in 2002 to 100% in 2007 and beyond,” and “self-reporting of incidents rose from 709 per quarter in 2002 to 1,481 per quarter in 2008.”
Disclosures: Dr. Sax serves as a medical consultant to Indelta Learning Systems Inc., which codeveloped the CRM training; one coauthor is an Indelta employee.
Extended VTE Prophylaxis Helpful After Surgery
SAN DIEGO — Two-thirds of patients placed on thromboprophylaxis after total hip or knee replacement surgery receive it for 2 weeks or less—and their venous thromboembolic event rate is markedly higher than in patients on prophylaxis for longer, according to a retrospective study of more than 3,000 patients.
Moreover, the rate of major bleeding in this study was fourfold greater in patients on prophylaxis for 14 days or less than in those on longer-term prophylaxis, contrary to the conventional wisdom that major bleeding risk rises with increasing duration of prophylaxis, Dr. Philip Wells said at the annual meeting of the American College of Chest Physicians.
He reported on a study of 3,195 adults in a U.S. managed care database who underwent total hip or knee replacement in 2004–2006 and received prophylaxis against venous thromboembolic events (VTE) with an ACCP-recommended agent for at least 1 day, starting within 24 hours after surgery. The patients represented only 43% of the hip/knee replacement patients in the database, meaning that most patients hospitalized for major orthopedic surgery did not receive any guideline-recommended VTE prophylaxis.
ACCP guidelines recommend extending thromboprophylaxis beyond 10 days and up to 35 days after total hip or knee replacement surgery, but the findings suggest that “the concept of extended prophylaxis may not have filtered into widespread clinical use,” said Dr. Wells, professor of medicine at the University of Ottawa and chair of the department of medicine at Ottawa Hospital.
A total of 67% of patients received what Dr. Wells termed “shorter-duration” prophylaxis of 14 days or less. Their incidence of VTE during the next 3 months was 3.96%, significantly greater than the 1.43% rate among patients with extended-duration prophylaxis for 15 days or longer.
The shorter-duration prophylaxis group also had a more than twofold increased rate of deep vein thrombosis, a sixfold greater incidence of pulmonary embolism, and a fourfold increase in major bleeding. (See box.) All of these differences were statistically significant. However, the difference in minor bleeding rates—a 3.91% incidence with shorter-duration prophylaxis vs. 2.98% with extended prophylaxis—did not reach significance.
Upon adjustment for potential confounders including age, baseline comorbidity, and oral vs. injectable prophylaxis, extended-duration prophylaxis remained beneficial. The risk of VTE with extended prophylaxis was 60% lower than with shorter-duration therapy. The risks of pulmonary embolism and major bleeding in the extended prophylaxis group were one-fifth and one-quarter of those who had shorter-duration prophylaxis.
When outcomes were compared between the 831 patients who received more than 21 days of thromboprophylaxis and those with 1–21 days of prophylaxis, extended prophylaxis still provided significant advantages. These included deep vein thrombosis and pulmonary embolism rates of 1.2% and 0.12%, respectively, compared with 2.7% and 1.06% in patients who had up to 21 days of prophylaxis.
A total of 58% of major bleeding events in the shorter-duration prophylaxis group occurred during the first 3 weeks post surgery, and roughly half of these early major bleeds happened in the first 2 days.
Even when Dr. Wells excluded all patients who had a major bleeding event, there was still a significant difference in VTEs between the shorter- and extended-duration prophylaxis groups. “It wasn't that the bleeders were the ones getting the clots. Shorter-duration prophylaxis definitely seems to be associated with a higher risk of clotting,” he said.
Several audience members expressed frustration that decisions about postsurgical VTE prophylaxis typically rest in the orthopedic surgeons' hands. They complained that many surgeons are reluctant to employ guideline-recommended prophylaxis because if a patient on prophylaxis develops bleeding, it will be blamed on the surgeon.
“These data show that in actual life, bleeding is not a risk with extended prophylaxis. The surgeons make the decision. All you can do is show them the information and hope they believe it. It's their patient. But if they don't believe real data, what can I say?” Dr. Wells replied.
Disclosures: The study was funded by Johnson & Johnson and Bayer Corp. Dr. Wells serves as a paid consultant to and is on the speakers bureaus for both firms.
Source ELSEVIER GLOBAL MEDICAL NEWS
SAN DIEGO — Two-thirds of patients placed on thromboprophylaxis after total hip or knee replacement surgery receive it for 2 weeks or less—and their venous thromboembolic event rate is markedly higher than in patients on prophylaxis for longer, according to a retrospective study of more than 3,000 patients.
Moreover, the rate of major bleeding in this study was fourfold greater in patients on prophylaxis for 14 days or less than in those on longer-term prophylaxis, contrary to the conventional wisdom that major bleeding risk rises with increasing duration of prophylaxis, Dr. Philip Wells said at the annual meeting of the American College of Chest Physicians.
He reported on a study of 3,195 adults in a U.S. managed care database who underwent total hip or knee replacement in 2004–2006 and received prophylaxis against venous thromboembolic events (VTE) with an ACCP-recommended agent for at least 1 day, starting within 24 hours after surgery. The patients represented only 43% of the hip/knee replacement patients in the database, meaning that most patients hospitalized for major orthopedic surgery did not receive any guideline-recommended VTE prophylaxis.
ACCP guidelines recommend extending thromboprophylaxis beyond 10 days and up to 35 days after total hip or knee replacement surgery, but the findings suggest that “the concept of extended prophylaxis may not have filtered into widespread clinical use,” said Dr. Wells, professor of medicine at the University of Ottawa and chair of the department of medicine at Ottawa Hospital.
A total of 67% of patients received what Dr. Wells termed “shorter-duration” prophylaxis of 14 days or less. Their incidence of VTE during the next 3 months was 3.96%, significantly greater than the 1.43% rate among patients with extended-duration prophylaxis for 15 days or longer.
The shorter-duration prophylaxis group also had a more than twofold increased rate of deep vein thrombosis, a sixfold greater incidence of pulmonary embolism, and a fourfold increase in major bleeding. (See box.) All of these differences were statistically significant. However, the difference in minor bleeding rates—a 3.91% incidence with shorter-duration prophylaxis vs. 2.98% with extended prophylaxis—did not reach significance.
Upon adjustment for potential confounders including age, baseline comorbidity, and oral vs. injectable prophylaxis, extended-duration prophylaxis remained beneficial. The risk of VTE with extended prophylaxis was 60% lower than with shorter-duration therapy. The risks of pulmonary embolism and major bleeding in the extended prophylaxis group were one-fifth and one-quarter of those who had shorter-duration prophylaxis.
When outcomes were compared between the 831 patients who received more than 21 days of thromboprophylaxis and those with 1–21 days of prophylaxis, extended prophylaxis still provided significant advantages. These included deep vein thrombosis and pulmonary embolism rates of 1.2% and 0.12%, respectively, compared with 2.7% and 1.06% in patients who had up to 21 days of prophylaxis.
A total of 58% of major bleeding events in the shorter-duration prophylaxis group occurred during the first 3 weeks post surgery, and roughly half of these early major bleeds happened in the first 2 days.
Even when Dr. Wells excluded all patients who had a major bleeding event, there was still a significant difference in VTEs between the shorter- and extended-duration prophylaxis groups. “It wasn't that the bleeders were the ones getting the clots. Shorter-duration prophylaxis definitely seems to be associated with a higher risk of clotting,” he said.
Several audience members expressed frustration that decisions about postsurgical VTE prophylaxis typically rest in the orthopedic surgeons' hands. They complained that many surgeons are reluctant to employ guideline-recommended prophylaxis because if a patient on prophylaxis develops bleeding, it will be blamed on the surgeon.
“These data show that in actual life, bleeding is not a risk with extended prophylaxis. The surgeons make the decision. All you can do is show them the information and hope they believe it. It's their patient. But if they don't believe real data, what can I say?” Dr. Wells replied.
Disclosures: The study was funded by Johnson & Johnson and Bayer Corp. Dr. Wells serves as a paid consultant to and is on the speakers bureaus for both firms.
Source ELSEVIER GLOBAL MEDICAL NEWS
SAN DIEGO — Two-thirds of patients placed on thromboprophylaxis after total hip or knee replacement surgery receive it for 2 weeks or less—and their venous thromboembolic event rate is markedly higher than in patients on prophylaxis for longer, according to a retrospective study of more than 3,000 patients.
Moreover, the rate of major bleeding in this study was fourfold greater in patients on prophylaxis for 14 days or less than in those on longer-term prophylaxis, contrary to the conventional wisdom that major bleeding risk rises with increasing duration of prophylaxis, Dr. Philip Wells said at the annual meeting of the American College of Chest Physicians.
He reported on a study of 3,195 adults in a U.S. managed care database who underwent total hip or knee replacement in 2004–2006 and received prophylaxis against venous thromboembolic events (VTE) with an ACCP-recommended agent for at least 1 day, starting within 24 hours after surgery. The patients represented only 43% of the hip/knee replacement patients in the database, meaning that most patients hospitalized for major orthopedic surgery did not receive any guideline-recommended VTE prophylaxis.
ACCP guidelines recommend extending thromboprophylaxis beyond 10 days and up to 35 days after total hip or knee replacement surgery, but the findings suggest that “the concept of extended prophylaxis may not have filtered into widespread clinical use,” said Dr. Wells, professor of medicine at the University of Ottawa and chair of the department of medicine at Ottawa Hospital.
A total of 67% of patients received what Dr. Wells termed “shorter-duration” prophylaxis of 14 days or less. Their incidence of VTE during the next 3 months was 3.96%, significantly greater than the 1.43% rate among patients with extended-duration prophylaxis for 15 days or longer.
The shorter-duration prophylaxis group also had a more than twofold increased rate of deep vein thrombosis, a sixfold greater incidence of pulmonary embolism, and a fourfold increase in major bleeding. (See box.) All of these differences were statistically significant. However, the difference in minor bleeding rates—a 3.91% incidence with shorter-duration prophylaxis vs. 2.98% with extended prophylaxis—did not reach significance.
Upon adjustment for potential confounders including age, baseline comorbidity, and oral vs. injectable prophylaxis, extended-duration prophylaxis remained beneficial. The risk of VTE with extended prophylaxis was 60% lower than with shorter-duration therapy. The risks of pulmonary embolism and major bleeding in the extended prophylaxis group were one-fifth and one-quarter of those who had shorter-duration prophylaxis.
When outcomes were compared between the 831 patients who received more than 21 days of thromboprophylaxis and those with 1–21 days of prophylaxis, extended prophylaxis still provided significant advantages. These included deep vein thrombosis and pulmonary embolism rates of 1.2% and 0.12%, respectively, compared with 2.7% and 1.06% in patients who had up to 21 days of prophylaxis.
A total of 58% of major bleeding events in the shorter-duration prophylaxis group occurred during the first 3 weeks post surgery, and roughly half of these early major bleeds happened in the first 2 days.
Even when Dr. Wells excluded all patients who had a major bleeding event, there was still a significant difference in VTEs between the shorter- and extended-duration prophylaxis groups. “It wasn't that the bleeders were the ones getting the clots. Shorter-duration prophylaxis definitely seems to be associated with a higher risk of clotting,” he said.
Several audience members expressed frustration that decisions about postsurgical VTE prophylaxis typically rest in the orthopedic surgeons' hands. They complained that many surgeons are reluctant to employ guideline-recommended prophylaxis because if a patient on prophylaxis develops bleeding, it will be blamed on the surgeon.
“These data show that in actual life, bleeding is not a risk with extended prophylaxis. The surgeons make the decision. All you can do is show them the information and hope they believe it. It's their patient. But if they don't believe real data, what can I say?” Dr. Wells replied.
Disclosures: The study was funded by Johnson & Johnson and Bayer Corp. Dr. Wells serves as a paid consultant to and is on the speakers bureaus for both firms.
Source ELSEVIER GLOBAL MEDICAL NEWS
Haitian Patients Receive Help From U.S. Hospitalists
When Dr. Lisa V. Luly-Rivera admitted the 14-year-old girl to the University of Miami's tent hospital at the airport in Port-au-Prince, the girl's leg was edematous and she had some hyperpigmentation. But between one day and the next, her leg became warm, and the warmth started moving up toward her thigh. The leg was clearly infected.
The surgeons, fearing necrotizing fasciitis, wanted to amputate. Dr. Luly-Rivera, a hospitalist at the University of Miami who was in Haiti to help earthquake victims, found herself arguing with the surgeons.
“No, that's not what you do and you know it,” she recalls saying. “You don't just have to preemptively amputate.”
She pointed out that the girl could still move her leg, and it had some range of motion. She knew she had some good antibiotics—Rocephin, Flagyl, and Clindal—to provide multiorganism coverage. So she insisted that the surgeons do a fasciotomy. Then she treated the girl with IV antibiotics and hoped the infection would abate. It did, and the girl kept her leg.
Dr. Luly-Rivera arrived in Haiti just 8 days after the devastating earthquake on Jan. 12, 2010. A Haitian-American who was born in Queens, N.Y., Dr. Luly-Rivera has many friends and relatives still living in that poverty-stricken country, and fortunately none was seriously hurt. But she knew that her skills as a hospitalist—and the fact that she spoke fluent Creole—could be put to good use during her 5-day visit.
She wasn't alone. The University of Miami Leonard M. Miller School of Medicine has had a presence in Haiti since 1994 through Project Medishare, a program founded by Dr. Barth Green and Dr. Arthur Fournier. University physicians quickly organized into teams that would spend 5 days in Haiti providing emergency medical and surgical care.
At first they set up a hospital at a United Nations facility, but just a day after Dr. Luly-Rivera and her hospitalist colleague Dr. Amir K. Jaffer arrived, the university constructed a field hospital at the Port-au-Prince airport. The hospital, in four large tents with three operating rooms, was equipped to handle 250 patients.
Two days after the field hospital opened, the first radiology machine arrived. “Patients were already getting amputations in the operating room for injuries that were not likely to heal or that were leading to wound infections or compartment syndromes,” Dr. Jaffer recalled. “But those where the fractures were more occult, where they were not visible but they still had a lot of pain, they were splinted and stabilized. And then they started to get casts when we had an x-ray machine available on-site.”
Dr. Jaffer, who has special expertise in deep vein thrombosis (DVT), was glad to see that the hospital had heparin and low-molecular-weight heparin. Many patients had fractures of a long bone, so Dr. Jaffer started these high-risk patients on prophylaxis.
Dr. Jaffer and Dr. Luly-Rivera both said they did anything that needed doing, from starting IV lines to bringing food to patients. But they also used their training as hospitalists to comanage patients along with the surgeons. The hospitalists managed patients' fluids, pain, and antibiotics.
They worked in shifts that were nominally 12 hours long, but sometimes ended up lasting 15 or even 20 hours. During a night shift, Dr. Luly-Rivera noticed something strange about a 17-year-old boy she had admitted the day before. The boy had a hemopneumothorax, but no chest tubes were available, so the surgeons had improvised one with a Foley catheter and some surgical tubing.
That night Dr. Luly-Rivera noticed the boy was lethargic and unresponsive, although she recalled he had been able to follow commands earlier in the day. “I said to myself, 'OK, we don't have all of the resources here. We have to send him to the Israeli hospital [which was better equipped].' So I woke up the entire surgical team,” she said. “I said, 'This patient is going to crash tonight if we don't transfer him.' And everyone started arguing: 'We don't have security.' 'How are we going to transfer him over?' 'Well, he's not crashing right now.' And I said, 'He will die tonight if we don't do something.'”
Dr. Luly-Rivera found some of the EMTs who were there from Miami, who agreed to have the boy transferred to the Israeli hospital, where he got a proper chest tube. “He was so critical that they shipped him to the U.S.N.S. Comfort [the U.S. Navy's hospital ship docked at the waterfront]. I just got a report back on Tuesday. He's doing much better.”
Dr. Luly-Rivera expressed mixed emotions about her experience in Haiti. At first she said, “I enjoyed my time down there,” but a minute later she said, “It was extremely difficult to witness what was going on … and to see the suffering of the patients. It was difficult to see all the children being amputated, the adults. I just left there with the sense of, what's going to happen to this generation of people? It was very disheartening.”
Dr. Jaffer said that he was struck by how calm everyone at the hospital was. “I was amazed with how patient people were,” he said. “I did not ever see anybody in my 5 days there getting angry with anyone else. … I was amazed at how patient these Haitian people were with both each other and the help they were getting from people around them.”
On the other hand, “there was a lot of fear in these people's eyes and their body language. We would talk to them about what their fears were, but the truth of the matter is there was no systematic way to address that.” Addressing the posttraumatic stress disorder after such an event “is something we need to think about,” said Dr. Jaffer, adding that he saw no psychiatrists or other mental health professionals while he was there.
Dr. Luly-Rivera urged other hospitalists to spend a few days helping out in Haiti. “As hospitalists, a lot of people are scared to go there,” she said. “They don't know what to expect. You're not just doing hospitalist work. You're doing everything. You're just there to take care of patients in whatever way you can. The experience was so rewarding for me. I want to go back. But it does take a toll on you. You come back changed.”
Dr. Lisa V. Luly-Rivera of the University of Miami put her hospitalist skills to use during a 5-day visit during the second week following the earthquake in Haiti.
Source COURTESY AMIR K. JAFFER
Among the U.S. physicians responding to the crisis in Haiti were Dr. Mario Reyes, chief of hospital medicine at Miami Children's Hospital; Dr. Barth Green, chief of neurosurgery at the University of Miami and a founder of Project Medishare; and Dr. Amir K. Jaffer, chief of hospital medicine at the University of Miami.
Source COURTESY AMIR K. JAFFER
When Dr. Lisa V. Luly-Rivera admitted the 14-year-old girl to the University of Miami's tent hospital at the airport in Port-au-Prince, the girl's leg was edematous and she had some hyperpigmentation. But between one day and the next, her leg became warm, and the warmth started moving up toward her thigh. The leg was clearly infected.
The surgeons, fearing necrotizing fasciitis, wanted to amputate. Dr. Luly-Rivera, a hospitalist at the University of Miami who was in Haiti to help earthquake victims, found herself arguing with the surgeons.
“No, that's not what you do and you know it,” she recalls saying. “You don't just have to preemptively amputate.”
She pointed out that the girl could still move her leg, and it had some range of motion. She knew she had some good antibiotics—Rocephin, Flagyl, and Clindal—to provide multiorganism coverage. So she insisted that the surgeons do a fasciotomy. Then she treated the girl with IV antibiotics and hoped the infection would abate. It did, and the girl kept her leg.
Dr. Luly-Rivera arrived in Haiti just 8 days after the devastating earthquake on Jan. 12, 2010. A Haitian-American who was born in Queens, N.Y., Dr. Luly-Rivera has many friends and relatives still living in that poverty-stricken country, and fortunately none was seriously hurt. But she knew that her skills as a hospitalist—and the fact that she spoke fluent Creole—could be put to good use during her 5-day visit.
She wasn't alone. The University of Miami Leonard M. Miller School of Medicine has had a presence in Haiti since 1994 through Project Medishare, a program founded by Dr. Barth Green and Dr. Arthur Fournier. University physicians quickly organized into teams that would spend 5 days in Haiti providing emergency medical and surgical care.
At first they set up a hospital at a United Nations facility, but just a day after Dr. Luly-Rivera and her hospitalist colleague Dr. Amir K. Jaffer arrived, the university constructed a field hospital at the Port-au-Prince airport. The hospital, in four large tents with three operating rooms, was equipped to handle 250 patients.
Two days after the field hospital opened, the first radiology machine arrived. “Patients were already getting amputations in the operating room for injuries that were not likely to heal or that were leading to wound infections or compartment syndromes,” Dr. Jaffer recalled. “But those where the fractures were more occult, where they were not visible but they still had a lot of pain, they were splinted and stabilized. And then they started to get casts when we had an x-ray machine available on-site.”
Dr. Jaffer, who has special expertise in deep vein thrombosis (DVT), was glad to see that the hospital had heparin and low-molecular-weight heparin. Many patients had fractures of a long bone, so Dr. Jaffer started these high-risk patients on prophylaxis.
Dr. Jaffer and Dr. Luly-Rivera both said they did anything that needed doing, from starting IV lines to bringing food to patients. But they also used their training as hospitalists to comanage patients along with the surgeons. The hospitalists managed patients' fluids, pain, and antibiotics.
They worked in shifts that were nominally 12 hours long, but sometimes ended up lasting 15 or even 20 hours. During a night shift, Dr. Luly-Rivera noticed something strange about a 17-year-old boy she had admitted the day before. The boy had a hemopneumothorax, but no chest tubes were available, so the surgeons had improvised one with a Foley catheter and some surgical tubing.
That night Dr. Luly-Rivera noticed the boy was lethargic and unresponsive, although she recalled he had been able to follow commands earlier in the day. “I said to myself, 'OK, we don't have all of the resources here. We have to send him to the Israeli hospital [which was better equipped].' So I woke up the entire surgical team,” she said. “I said, 'This patient is going to crash tonight if we don't transfer him.' And everyone started arguing: 'We don't have security.' 'How are we going to transfer him over?' 'Well, he's not crashing right now.' And I said, 'He will die tonight if we don't do something.'”
Dr. Luly-Rivera found some of the EMTs who were there from Miami, who agreed to have the boy transferred to the Israeli hospital, where he got a proper chest tube. “He was so critical that they shipped him to the U.S.N.S. Comfort [the U.S. Navy's hospital ship docked at the waterfront]. I just got a report back on Tuesday. He's doing much better.”
Dr. Luly-Rivera expressed mixed emotions about her experience in Haiti. At first she said, “I enjoyed my time down there,” but a minute later she said, “It was extremely difficult to witness what was going on … and to see the suffering of the patients. It was difficult to see all the children being amputated, the adults. I just left there with the sense of, what's going to happen to this generation of people? It was very disheartening.”
Dr. Jaffer said that he was struck by how calm everyone at the hospital was. “I was amazed with how patient people were,” he said. “I did not ever see anybody in my 5 days there getting angry with anyone else. … I was amazed at how patient these Haitian people were with both each other and the help they were getting from people around them.”
On the other hand, “there was a lot of fear in these people's eyes and their body language. We would talk to them about what their fears were, but the truth of the matter is there was no systematic way to address that.” Addressing the posttraumatic stress disorder after such an event “is something we need to think about,” said Dr. Jaffer, adding that he saw no psychiatrists or other mental health professionals while he was there.
Dr. Luly-Rivera urged other hospitalists to spend a few days helping out in Haiti. “As hospitalists, a lot of people are scared to go there,” she said. “They don't know what to expect. You're not just doing hospitalist work. You're doing everything. You're just there to take care of patients in whatever way you can. The experience was so rewarding for me. I want to go back. But it does take a toll on you. You come back changed.”
Dr. Lisa V. Luly-Rivera of the University of Miami put her hospitalist skills to use during a 5-day visit during the second week following the earthquake in Haiti.
Source COURTESY AMIR K. JAFFER
Among the U.S. physicians responding to the crisis in Haiti were Dr. Mario Reyes, chief of hospital medicine at Miami Children's Hospital; Dr. Barth Green, chief of neurosurgery at the University of Miami and a founder of Project Medishare; and Dr. Amir K. Jaffer, chief of hospital medicine at the University of Miami.
Source COURTESY AMIR K. JAFFER
When Dr. Lisa V. Luly-Rivera admitted the 14-year-old girl to the University of Miami's tent hospital at the airport in Port-au-Prince, the girl's leg was edematous and she had some hyperpigmentation. But between one day and the next, her leg became warm, and the warmth started moving up toward her thigh. The leg was clearly infected.
The surgeons, fearing necrotizing fasciitis, wanted to amputate. Dr. Luly-Rivera, a hospitalist at the University of Miami who was in Haiti to help earthquake victims, found herself arguing with the surgeons.
“No, that's not what you do and you know it,” she recalls saying. “You don't just have to preemptively amputate.”
She pointed out that the girl could still move her leg, and it had some range of motion. She knew she had some good antibiotics—Rocephin, Flagyl, and Clindal—to provide multiorganism coverage. So she insisted that the surgeons do a fasciotomy. Then she treated the girl with IV antibiotics and hoped the infection would abate. It did, and the girl kept her leg.
Dr. Luly-Rivera arrived in Haiti just 8 days after the devastating earthquake on Jan. 12, 2010. A Haitian-American who was born in Queens, N.Y., Dr. Luly-Rivera has many friends and relatives still living in that poverty-stricken country, and fortunately none was seriously hurt. But she knew that her skills as a hospitalist—and the fact that she spoke fluent Creole—could be put to good use during her 5-day visit.
She wasn't alone. The University of Miami Leonard M. Miller School of Medicine has had a presence in Haiti since 1994 through Project Medishare, a program founded by Dr. Barth Green and Dr. Arthur Fournier. University physicians quickly organized into teams that would spend 5 days in Haiti providing emergency medical and surgical care.
At first they set up a hospital at a United Nations facility, but just a day after Dr. Luly-Rivera and her hospitalist colleague Dr. Amir K. Jaffer arrived, the university constructed a field hospital at the Port-au-Prince airport. The hospital, in four large tents with three operating rooms, was equipped to handle 250 patients.
Two days after the field hospital opened, the first radiology machine arrived. “Patients were already getting amputations in the operating room for injuries that were not likely to heal or that were leading to wound infections or compartment syndromes,” Dr. Jaffer recalled. “But those where the fractures were more occult, where they were not visible but they still had a lot of pain, they were splinted and stabilized. And then they started to get casts when we had an x-ray machine available on-site.”
Dr. Jaffer, who has special expertise in deep vein thrombosis (DVT), was glad to see that the hospital had heparin and low-molecular-weight heparin. Many patients had fractures of a long bone, so Dr. Jaffer started these high-risk patients on prophylaxis.
Dr. Jaffer and Dr. Luly-Rivera both said they did anything that needed doing, from starting IV lines to bringing food to patients. But they also used their training as hospitalists to comanage patients along with the surgeons. The hospitalists managed patients' fluids, pain, and antibiotics.
They worked in shifts that were nominally 12 hours long, but sometimes ended up lasting 15 or even 20 hours. During a night shift, Dr. Luly-Rivera noticed something strange about a 17-year-old boy she had admitted the day before. The boy had a hemopneumothorax, but no chest tubes were available, so the surgeons had improvised one with a Foley catheter and some surgical tubing.
That night Dr. Luly-Rivera noticed the boy was lethargic and unresponsive, although she recalled he had been able to follow commands earlier in the day. “I said to myself, 'OK, we don't have all of the resources here. We have to send him to the Israeli hospital [which was better equipped].' So I woke up the entire surgical team,” she said. “I said, 'This patient is going to crash tonight if we don't transfer him.' And everyone started arguing: 'We don't have security.' 'How are we going to transfer him over?' 'Well, he's not crashing right now.' And I said, 'He will die tonight if we don't do something.'”
Dr. Luly-Rivera found some of the EMTs who were there from Miami, who agreed to have the boy transferred to the Israeli hospital, where he got a proper chest tube. “He was so critical that they shipped him to the U.S.N.S. Comfort [the U.S. Navy's hospital ship docked at the waterfront]. I just got a report back on Tuesday. He's doing much better.”
Dr. Luly-Rivera expressed mixed emotions about her experience in Haiti. At first she said, “I enjoyed my time down there,” but a minute later she said, “It was extremely difficult to witness what was going on … and to see the suffering of the patients. It was difficult to see all the children being amputated, the adults. I just left there with the sense of, what's going to happen to this generation of people? It was very disheartening.”
Dr. Jaffer said that he was struck by how calm everyone at the hospital was. “I was amazed with how patient people were,” he said. “I did not ever see anybody in my 5 days there getting angry with anyone else. … I was amazed at how patient these Haitian people were with both each other and the help they were getting from people around them.”
On the other hand, “there was a lot of fear in these people's eyes and their body language. We would talk to them about what their fears were, but the truth of the matter is there was no systematic way to address that.” Addressing the posttraumatic stress disorder after such an event “is something we need to think about,” said Dr. Jaffer, adding that he saw no psychiatrists or other mental health professionals while he was there.
Dr. Luly-Rivera urged other hospitalists to spend a few days helping out in Haiti. “As hospitalists, a lot of people are scared to go there,” she said. “They don't know what to expect. You're not just doing hospitalist work. You're doing everything. You're just there to take care of patients in whatever way you can. The experience was so rewarding for me. I want to go back. But it does take a toll on you. You come back changed.”
Dr. Lisa V. Luly-Rivera of the University of Miami put her hospitalist skills to use during a 5-day visit during the second week following the earthquake in Haiti.
Source COURTESY AMIR K. JAFFER
Among the U.S. physicians responding to the crisis in Haiti were Dr. Mario Reyes, chief of hospital medicine at Miami Children's Hospital; Dr. Barth Green, chief of neurosurgery at the University of Miami and a founder of Project Medishare; and Dr. Amir K. Jaffer, chief of hospital medicine at the University of Miami.
Source COURTESY AMIR K. JAFFER
Low Hemoglobin After Cardiac Surgery Increases Stroke Risk
BALTIMORE — A low hemoglobin level following cardiac surgery is associated with significantly increased odds of experiencing a stroke after cardiopulmonary bypass, results of a case-control study suggest.
Although previous studies have associated anemia with adverse cerebrovascular outcomes, including stroke, it is unclear whether low hemoglobin levels contribute to postoperative surgical complications, Dr. Rebecca F. Gottesman and her colleagues at Johns Hopkins University, Baltimore, said in a poster presented at the annual meeting of the American Neurological Association.
The researchers identified the postoperative outcomes of 357 patients who underwent various cardiac surgery procedures with cardiopulmonary bypass at Johns Hopkins Hospital and compared them with the outcomes of 714 control patients matched by age range, gender, and type and year of surgery.
The patients had a mean age of 65 years, and 59% in each group were male. Compared with controls, stroke patients were significantly more likely to have hypertension (77% vs. 68%) and peripheral vascular disease (20% vs. 10%). The stroke and control groups had similar rates of diabetes (30% vs. 25%, respectively), history of MI (37% vs. 32%), and high cholesterol (51% vs. 45%), Dr. Gottesman and her associates reported.
In a conditional logistic regression analysis, the researchers found that, for each 1 g/dL decline in hemoglobin, the odds of having a stroke significantly increased by 37%. Patients with a postoperative hemoglobin level below the group median of 8.8 g/dL had a 78% greater chance of having a stroke than did those above the median. (Normal hemoglobin levels are greater than 13 g/dL in men and greater than 12 g/dL in women.)
Postoperative hemoglobin levels were below the median in significantly more patients who had a new stroke (57%) than in those who did not have a stroke (41%).
“The association between stroke and post–cardiopulmonary bypass hemoglobin could be the result of hemodilution or cerebral hypoperfusion,” the investigators suggested.
The study was supported by grants from the National Institutes of Health and the Dana Foundation.
BALTIMORE — A low hemoglobin level following cardiac surgery is associated with significantly increased odds of experiencing a stroke after cardiopulmonary bypass, results of a case-control study suggest.
Although previous studies have associated anemia with adverse cerebrovascular outcomes, including stroke, it is unclear whether low hemoglobin levels contribute to postoperative surgical complications, Dr. Rebecca F. Gottesman and her colleagues at Johns Hopkins University, Baltimore, said in a poster presented at the annual meeting of the American Neurological Association.
The researchers identified the postoperative outcomes of 357 patients who underwent various cardiac surgery procedures with cardiopulmonary bypass at Johns Hopkins Hospital and compared them with the outcomes of 714 control patients matched by age range, gender, and type and year of surgery.
The patients had a mean age of 65 years, and 59% in each group were male. Compared with controls, stroke patients were significantly more likely to have hypertension (77% vs. 68%) and peripheral vascular disease (20% vs. 10%). The stroke and control groups had similar rates of diabetes (30% vs. 25%, respectively), history of MI (37% vs. 32%), and high cholesterol (51% vs. 45%), Dr. Gottesman and her associates reported.
In a conditional logistic regression analysis, the researchers found that, for each 1 g/dL decline in hemoglobin, the odds of having a stroke significantly increased by 37%. Patients with a postoperative hemoglobin level below the group median of 8.8 g/dL had a 78% greater chance of having a stroke than did those above the median. (Normal hemoglobin levels are greater than 13 g/dL in men and greater than 12 g/dL in women.)
Postoperative hemoglobin levels were below the median in significantly more patients who had a new stroke (57%) than in those who did not have a stroke (41%).
“The association between stroke and post–cardiopulmonary bypass hemoglobin could be the result of hemodilution or cerebral hypoperfusion,” the investigators suggested.
The study was supported by grants from the National Institutes of Health and the Dana Foundation.
BALTIMORE — A low hemoglobin level following cardiac surgery is associated with significantly increased odds of experiencing a stroke after cardiopulmonary bypass, results of a case-control study suggest.
Although previous studies have associated anemia with adverse cerebrovascular outcomes, including stroke, it is unclear whether low hemoglobin levels contribute to postoperative surgical complications, Dr. Rebecca F. Gottesman and her colleagues at Johns Hopkins University, Baltimore, said in a poster presented at the annual meeting of the American Neurological Association.
The researchers identified the postoperative outcomes of 357 patients who underwent various cardiac surgery procedures with cardiopulmonary bypass at Johns Hopkins Hospital and compared them with the outcomes of 714 control patients matched by age range, gender, and type and year of surgery.
The patients had a mean age of 65 years, and 59% in each group were male. Compared with controls, stroke patients were significantly more likely to have hypertension (77% vs. 68%) and peripheral vascular disease (20% vs. 10%). The stroke and control groups had similar rates of diabetes (30% vs. 25%, respectively), history of MI (37% vs. 32%), and high cholesterol (51% vs. 45%), Dr. Gottesman and her associates reported.
In a conditional logistic regression analysis, the researchers found that, for each 1 g/dL decline in hemoglobin, the odds of having a stroke significantly increased by 37%. Patients with a postoperative hemoglobin level below the group median of 8.8 g/dL had a 78% greater chance of having a stroke than did those above the median. (Normal hemoglobin levels are greater than 13 g/dL in men and greater than 12 g/dL in women.)
Postoperative hemoglobin levels were below the median in significantly more patients who had a new stroke (57%) than in those who did not have a stroke (41%).
“The association between stroke and post–cardiopulmonary bypass hemoglobin could be the result of hemodilution or cerebral hypoperfusion,” the investigators suggested.
The study was supported by grants from the National Institutes of Health and the Dana Foundation.
Risk Factors Identified for Hernia Repair Outcomes
CHICAGO — Controlling preoperative wound infections prior to repair of ventral hernias might reduce the risk of severe adverse outcomes, according to an analysis based on records from the American College of Surgeons' National Surgical Quality Improvement Program.
Of note, 21% of patients who had severe adverse outcomes within 30 days of ventral hernia surgery had a deep-incision infection. A total of 37% were diagnosed with sepsis, and more than 50% had to return to the operating room.
The findings suggest that preoperative infection control could be beneficial, said Dr. Brook V. Nelson, a surgical fellow at St. Luke's Hospital and the University of Missouri–Kansas City. Some “risks for severe adverse outcomes can be predicted at the time we are making the operative decision” in ventral hernia patients, Dr. Nelson said at the annual clinical congress of the American College of Surgeons.
The multivariate logistic regression analysis by Dr. Nelson and her colleagues indicated that three preoperative risk factors—high body mass index, dependent functional status, and active wound infection—are associated with an increased risk of severe adverse outcomes.
They analyzed the records of 14,883 patients who underwent ventral hernia repair from 2005 to 2007 and were included in the National Surgical Quality Improvement Program database. Severe adverse outcomes occurred within 30 days in 1,106 (7%). A total of 16% of patients with severe adverse outcomes underwent emergency procedures versus 6% of patients without severe adverse outcomes.
In addition to wound infection, preoperative BMI greater than 35 kg/m
Cessation of cigarette smoking, pulmonary optimization, and delay of surgery for patients with wound infections also are potentially useful interventions identified by the study, Dr. Nelson said.
Patients with severe adverse outcomes were slightly older, with a mean age of 58 years compared with 56 years. Chronic obstructive pulmonary disease, recurrent hernia, and complex surgical repairs also conveyed increased risk, she added.
Dr. Nelson said she had no relevant disclosures.
CHICAGO — Controlling preoperative wound infections prior to repair of ventral hernias might reduce the risk of severe adverse outcomes, according to an analysis based on records from the American College of Surgeons' National Surgical Quality Improvement Program.
Of note, 21% of patients who had severe adverse outcomes within 30 days of ventral hernia surgery had a deep-incision infection. A total of 37% were diagnosed with sepsis, and more than 50% had to return to the operating room.
The findings suggest that preoperative infection control could be beneficial, said Dr. Brook V. Nelson, a surgical fellow at St. Luke's Hospital and the University of Missouri–Kansas City. Some “risks for severe adverse outcomes can be predicted at the time we are making the operative decision” in ventral hernia patients, Dr. Nelson said at the annual clinical congress of the American College of Surgeons.
The multivariate logistic regression analysis by Dr. Nelson and her colleagues indicated that three preoperative risk factors—high body mass index, dependent functional status, and active wound infection—are associated with an increased risk of severe adverse outcomes.
They analyzed the records of 14,883 patients who underwent ventral hernia repair from 2005 to 2007 and were included in the National Surgical Quality Improvement Program database. Severe adverse outcomes occurred within 30 days in 1,106 (7%). A total of 16% of patients with severe adverse outcomes underwent emergency procedures versus 6% of patients without severe adverse outcomes.
In addition to wound infection, preoperative BMI greater than 35 kg/m
Cessation of cigarette smoking, pulmonary optimization, and delay of surgery for patients with wound infections also are potentially useful interventions identified by the study, Dr. Nelson said.
Patients with severe adverse outcomes were slightly older, with a mean age of 58 years compared with 56 years. Chronic obstructive pulmonary disease, recurrent hernia, and complex surgical repairs also conveyed increased risk, she added.
Dr. Nelson said she had no relevant disclosures.
CHICAGO — Controlling preoperative wound infections prior to repair of ventral hernias might reduce the risk of severe adverse outcomes, according to an analysis based on records from the American College of Surgeons' National Surgical Quality Improvement Program.
Of note, 21% of patients who had severe adverse outcomes within 30 days of ventral hernia surgery had a deep-incision infection. A total of 37% were diagnosed with sepsis, and more than 50% had to return to the operating room.
The findings suggest that preoperative infection control could be beneficial, said Dr. Brook V. Nelson, a surgical fellow at St. Luke's Hospital and the University of Missouri–Kansas City. Some “risks for severe adverse outcomes can be predicted at the time we are making the operative decision” in ventral hernia patients, Dr. Nelson said at the annual clinical congress of the American College of Surgeons.
The multivariate logistic regression analysis by Dr. Nelson and her colleagues indicated that three preoperative risk factors—high body mass index, dependent functional status, and active wound infection—are associated with an increased risk of severe adverse outcomes.
They analyzed the records of 14,883 patients who underwent ventral hernia repair from 2005 to 2007 and were included in the National Surgical Quality Improvement Program database. Severe adverse outcomes occurred within 30 days in 1,106 (7%). A total of 16% of patients with severe adverse outcomes underwent emergency procedures versus 6% of patients without severe adverse outcomes.
In addition to wound infection, preoperative BMI greater than 35 kg/m
Cessation of cigarette smoking, pulmonary optimization, and delay of surgery for patients with wound infections also are potentially useful interventions identified by the study, Dr. Nelson said.
Patients with severe adverse outcomes were slightly older, with a mean age of 58 years compared with 56 years. Chronic obstructive pulmonary disease, recurrent hernia, and complex surgical repairs also conveyed increased risk, she added.
Dr. Nelson said she had no relevant disclosures.
Discharge to Institution Tied to Mortality Risk
CHICAGO — One in four elderly patients discharged to an institution after undergoing elective surgery died within 6 months, investigators found in a study designed to identify the incidence of and risk factors for postoperative admission to a skilled nursing center, rehabilitation center, or nursing home.
Although 30-day postoperative mortality for the 167 patients was similar (2% of the transferred patients versus 3% of those discharged to home), the 24% 6-month mortality rate among institutionalized patients was significantly greater than the 5% rate for those discharged, Dr. Arek J. Wiktor said at the annual clinical congress of the American College of Surgeons.
“Elderly patients often have functional decline following major surgery. But there is a lack of outcomes [information] on those who require postdischarge care,” Dr. Wiktor said.
He and his associate, Dr. Thomas N. Robinson, both with the University of Colorado at Denver, studied surgical patients aged 50 years and older (mean age, 63). Most (96%) were men.
A total 29 of the 167 patients (17%) required postoperative institutionalization, and there was a significant difference in institutionalization rates between those aged 70 years or older and younger patients, Dr. Wiktor said.
Operative time and blood loss did not differ significantly between patients transferred to a facility and those discharged to home. Mean operative times were 298 minutes in the facility group vs. 276 minutes in the discharge group, and mean blood loss was 561 mL versus 603 mL, respectively.
Identification of risk factors for institutionalization was a secondary aim of the study. Patients admitted to a facility after surgery were older (mean age of 70 years versus 64 years), had a longer ICU stay (11 days versus 6 days), and had a longer overall hospital stay (20 days versus 9 days) than those discharged to home.
“Preoperative markers of frailty strongly correlated with institutionalization,” Dr. Wiktor said. Preoperative cognitive function was assessed on the basis of the Mini-Cognitive Examination. The admitted patients had a mean score of 2.6 versus 4.0 in those ultimately discharged to home, a significant difference. Similarly, the mean preoperative function score was 88.5 in admitted patients versus 97.4 in those discharged to home, as measured on the Barthel Index scale. The researchers also found a significant difference in comorbidities on the Charlson Index: 4.9 in the admitted group versus 2.6 in the discharged group.
Dr. Martin A. Makary, a study discussant, asked why the investigators chose to assess patients 50 years and older for an “elderly” study.
Dr. Wiktor replied, “That is why we chose such a wide age group and started at 50. We didn't want to short-change ourselves if we saw a trend earlier versus later.”
Could the age disparity be explained by older patients undergoing more complex procedures? asked Dr. Makary, the Mark Ravitch Chair of Gastrointestinal Surgery and director of the Johns Hopkins Center for Surgical Outcomes in Baltimore.
Complexity was not likely a factor, Dr. Wiktor replied, because the investigators anticipated that all participants would be admitted to critical care after their elective surgery.
“Surprising to me was that four out of five of your elderly patients went home after major surgery,” said Dr. Hasan Badre Alam, a comoderator of the session. He commented that none of the risk factors identified are modifiable.
“It would be useful to identify risk factors that distinguish the 24% who are going to die [by 6 months] versus the 76% who will not,” said Dr. Alam, a staff surgeon at Massachusetts General Hospital, Boston.
“That is why this research is so interesting and sometimes frustrating,” Dr. Wiktor replied. “Patients come with comorbidities, and sometimes there is little you can do. But having a frank discussion with these patients before surgery may lead to them making small changes.”
My Take
Stratify Risks to Improve Outcomes
Modifiable risk factors for poor surgical outcome would be nice to have, but there would also be tremendous value in just being able to risk-stratify elderly patients preoperatively for a higher-quality informed consent discussion.
It has already been established that patients with dementia who undergo surgery do not fare as well postoperatively as patients without dementia. In this study, cognitive dysfunction is also linked to poor outcomes.
The more precisely we can stratify risk, the better we will be able to identify target groups for interventional studies that may be able to improve outcomes.
FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.
CHICAGO — One in four elderly patients discharged to an institution after undergoing elective surgery died within 6 months, investigators found in a study designed to identify the incidence of and risk factors for postoperative admission to a skilled nursing center, rehabilitation center, or nursing home.
Although 30-day postoperative mortality for the 167 patients was similar (2% of the transferred patients versus 3% of those discharged to home), the 24% 6-month mortality rate among institutionalized patients was significantly greater than the 5% rate for those discharged, Dr. Arek J. Wiktor said at the annual clinical congress of the American College of Surgeons.
“Elderly patients often have functional decline following major surgery. But there is a lack of outcomes [information] on those who require postdischarge care,” Dr. Wiktor said.
He and his associate, Dr. Thomas N. Robinson, both with the University of Colorado at Denver, studied surgical patients aged 50 years and older (mean age, 63). Most (96%) were men.
A total 29 of the 167 patients (17%) required postoperative institutionalization, and there was a significant difference in institutionalization rates between those aged 70 years or older and younger patients, Dr. Wiktor said.
Operative time and blood loss did not differ significantly between patients transferred to a facility and those discharged to home. Mean operative times were 298 minutes in the facility group vs. 276 minutes in the discharge group, and mean blood loss was 561 mL versus 603 mL, respectively.
Identification of risk factors for institutionalization was a secondary aim of the study. Patients admitted to a facility after surgery were older (mean age of 70 years versus 64 years), had a longer ICU stay (11 days versus 6 days), and had a longer overall hospital stay (20 days versus 9 days) than those discharged to home.
“Preoperative markers of frailty strongly correlated with institutionalization,” Dr. Wiktor said. Preoperative cognitive function was assessed on the basis of the Mini-Cognitive Examination. The admitted patients had a mean score of 2.6 versus 4.0 in those ultimately discharged to home, a significant difference. Similarly, the mean preoperative function score was 88.5 in admitted patients versus 97.4 in those discharged to home, as measured on the Barthel Index scale. The researchers also found a significant difference in comorbidities on the Charlson Index: 4.9 in the admitted group versus 2.6 in the discharged group.
Dr. Martin A. Makary, a study discussant, asked why the investigators chose to assess patients 50 years and older for an “elderly” study.
Dr. Wiktor replied, “That is why we chose such a wide age group and started at 50. We didn't want to short-change ourselves if we saw a trend earlier versus later.”
Could the age disparity be explained by older patients undergoing more complex procedures? asked Dr. Makary, the Mark Ravitch Chair of Gastrointestinal Surgery and director of the Johns Hopkins Center for Surgical Outcomes in Baltimore.
Complexity was not likely a factor, Dr. Wiktor replied, because the investigators anticipated that all participants would be admitted to critical care after their elective surgery.
“Surprising to me was that four out of five of your elderly patients went home after major surgery,” said Dr. Hasan Badre Alam, a comoderator of the session. He commented that none of the risk factors identified are modifiable.
“It would be useful to identify risk factors that distinguish the 24% who are going to die [by 6 months] versus the 76% who will not,” said Dr. Alam, a staff surgeon at Massachusetts General Hospital, Boston.
“That is why this research is so interesting and sometimes frustrating,” Dr. Wiktor replied. “Patients come with comorbidities, and sometimes there is little you can do. But having a frank discussion with these patients before surgery may lead to them making small changes.”
My Take
Stratify Risks to Improve Outcomes
Modifiable risk factors for poor surgical outcome would be nice to have, but there would also be tremendous value in just being able to risk-stratify elderly patients preoperatively for a higher-quality informed consent discussion.
It has already been established that patients with dementia who undergo surgery do not fare as well postoperatively as patients without dementia. In this study, cognitive dysfunction is also linked to poor outcomes.
The more precisely we can stratify risk, the better we will be able to identify target groups for interventional studies that may be able to improve outcomes.
FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.
CHICAGO — One in four elderly patients discharged to an institution after undergoing elective surgery died within 6 months, investigators found in a study designed to identify the incidence of and risk factors for postoperative admission to a skilled nursing center, rehabilitation center, or nursing home.
Although 30-day postoperative mortality for the 167 patients was similar (2% of the transferred patients versus 3% of those discharged to home), the 24% 6-month mortality rate among institutionalized patients was significantly greater than the 5% rate for those discharged, Dr. Arek J. Wiktor said at the annual clinical congress of the American College of Surgeons.
“Elderly patients often have functional decline following major surgery. But there is a lack of outcomes [information] on those who require postdischarge care,” Dr. Wiktor said.
He and his associate, Dr. Thomas N. Robinson, both with the University of Colorado at Denver, studied surgical patients aged 50 years and older (mean age, 63). Most (96%) were men.
A total 29 of the 167 patients (17%) required postoperative institutionalization, and there was a significant difference in institutionalization rates between those aged 70 years or older and younger patients, Dr. Wiktor said.
Operative time and blood loss did not differ significantly between patients transferred to a facility and those discharged to home. Mean operative times were 298 minutes in the facility group vs. 276 minutes in the discharge group, and mean blood loss was 561 mL versus 603 mL, respectively.
Identification of risk factors for institutionalization was a secondary aim of the study. Patients admitted to a facility after surgery were older (mean age of 70 years versus 64 years), had a longer ICU stay (11 days versus 6 days), and had a longer overall hospital stay (20 days versus 9 days) than those discharged to home.
“Preoperative markers of frailty strongly correlated with institutionalization,” Dr. Wiktor said. Preoperative cognitive function was assessed on the basis of the Mini-Cognitive Examination. The admitted patients had a mean score of 2.6 versus 4.0 in those ultimately discharged to home, a significant difference. Similarly, the mean preoperative function score was 88.5 in admitted patients versus 97.4 in those discharged to home, as measured on the Barthel Index scale. The researchers also found a significant difference in comorbidities on the Charlson Index: 4.9 in the admitted group versus 2.6 in the discharged group.
Dr. Martin A. Makary, a study discussant, asked why the investigators chose to assess patients 50 years and older for an “elderly” study.
Dr. Wiktor replied, “That is why we chose such a wide age group and started at 50. We didn't want to short-change ourselves if we saw a trend earlier versus later.”
Could the age disparity be explained by older patients undergoing more complex procedures? asked Dr. Makary, the Mark Ravitch Chair of Gastrointestinal Surgery and director of the Johns Hopkins Center for Surgical Outcomes in Baltimore.
Complexity was not likely a factor, Dr. Wiktor replied, because the investigators anticipated that all participants would be admitted to critical care after their elective surgery.
“Surprising to me was that four out of five of your elderly patients went home after major surgery,” said Dr. Hasan Badre Alam, a comoderator of the session. He commented that none of the risk factors identified are modifiable.
“It would be useful to identify risk factors that distinguish the 24% who are going to die [by 6 months] versus the 76% who will not,” said Dr. Alam, a staff surgeon at Massachusetts General Hospital, Boston.
“That is why this research is so interesting and sometimes frustrating,” Dr. Wiktor replied. “Patients come with comorbidities, and sometimes there is little you can do. But having a frank discussion with these patients before surgery may lead to them making small changes.”
My Take
Stratify Risks to Improve Outcomes
Modifiable risk factors for poor surgical outcome would be nice to have, but there would also be tremendous value in just being able to risk-stratify elderly patients preoperatively for a higher-quality informed consent discussion.
It has already been established that patients with dementia who undergo surgery do not fare as well postoperatively as patients without dementia. In this study, cognitive dysfunction is also linked to poor outcomes.
The more precisely we can stratify risk, the better we will be able to identify target groups for interventional studies that may be able to improve outcomes.
FRANK MICHOTA, M.D., is the Director of Academic Affairs in the Department of Hospital Medicine at the Cleveland Clinic. He reports no relevant conflicts of interest.
Unfractionated Heparin Best Deal for VTE Prophylaxis
PHOENIX — Low-dose unfractionated heparin for thromboprophylaxis following abdominopelvic cancer surgery gives the most protection for the lowest overall cost, a cost analysis showed.
With good patient compliance, low-dose unfractionated heparin after discharge was a better bargain than even daily aspirin at preventing venous thromboembolism (VTE), Dr. Ciaran Bradley reported at a symposium sponsored by the Society of Surgical Oncology.
“Low-dose unfractionated heparin in fact saves money over the currently commonplace practice of doing nothing,” Dr. Bradley said. “It would be cost effective even if compliance with medication were low,” he noted. “Only if the cost of low-molecular-weight heparin were less than $100 would it start to compete for dominance in the model, and currently, it's seven times more expensive than that.”
Aspirin also appears to be an attractive alternative in this clinical situation because of its low cost, oral administration, and absence of heparin-induced thrombocytopenia.
“Even though aspirin has been relatively discounted as a primary agent for thromboprophylaxis for inpatients in the perioperative setting, it may have some utility after the discharge period, and further clinical studies using aspirin for this very scenario may be warranted,” said Dr. Bradley of the Medical College of Wisconsin, Milwaukee.
Patients who undergo abdominopelvic cancer resection are at high risk for VTE, with a postdischarge rate up to 25% reported in one study (BMJ 1988;297:28). Up to 4 weeks of VTE prophylaxis is recommended in guidelines published by the American College of Chest Physicians, National Comprehensive Cancer Network, and American Society of Clinical Oncology, he noted.
“However, we postulate that these guidelines are rarely followed, likely because of concerns over the costs of the agents as a result of bleeding complications and heparin-induced thrombocytopenia, as well as concern that patients may not be compliant with medications because those currently used are injectable formulations,” he said.
Dr. Bradley and his colleagues created a model using a reference case of a patient more than 40 years old who has undergone an open or laparoscopic procedure for abdominopelvic malignancy under general anesthesia and lasting at least 45 minutes. The hypothetical patient received in-hospital chemical prophylaxis for VTE, and was discharged on the seventh postoperative day.
The authors compared the relative costs of four postdischarge thromboprophylaxis strategies: 40 mg of low-molecular-weight heparin given subcutaneously once daily, 5,000 U of low-dose unfractionated heparin given subcutaneously three times daily, 325 mg of aspirin given orally daily, and no prophylaxis. The model assumed a constant risk of VTE and bleeding complications over the 3 weeks after discharge.
The model also assumed that the patient would not always be compliant with dosing. For example, the model assumes that daily compliance with injectable low-molecular-weight heparin would be 79% with once-daily dosing, and that compliance would drop to 65% with injectable low-dose unfractionated heparin dosed three times daily.
Using Medicare and Red Book 2006 data, the authors determined that the cost of VTE would be $4,715, which includes hospitalization plus 6 months of subsequent warfarin therapy and monitoring. Heparin-induced thrombocytopenia would cost $5,184, which includes 5 days of treatment with the thrombin inhibitor lepirudin followed by warfarin for 6 months. Bleeding complications, primarily minor bleeds not requiring treatment but some requiring transfusion, would cost $388.
The cost to patients would be $623 for low-molecular-weight heparin, $72 for low-dose unfractionated heparin, and $2 for aspirin.
But when the researchers factored in the VTE rates associated with each medication in the baseline analysis, they found that low-dose unfractionated heparin was the low-cost leader. The differences would translate into annual population savings relative to no prophylaxis of $50.1 million for low-dose unfractionated heparin and $28.8 million for aspirin, compared with excess costs of $81.3 million for low-molecular-weight heparin.
“This is a great paper,” Dr. Edward A. Levine commented in a postpresentation discussion. “This is something we all wrestle with, since we all work with oncology patients who have more than one risk factor for DVT or VTE,” he said. However, “there are a number of papers that I've seen showing that aspirin doesn't do anything in terms of preventing thromboembolism at all,” noted Dr. Levine, who is chief of surgical oncology at Wake Forest University Baptist Medical Center in Winston-Salem, N.C.
Dr. Bradley agreed that in the inpatient setting, aspirin does not appear to protect against immediate VTEs. “However, some studies have looked at aspirin after the point of discharge, and they do show a benefit, particularly in patients who have an increased VTE risk,” he said.
Dr. Bradley said that he has no relevant financial disclosures.
PHOENIX — Low-dose unfractionated heparin for thromboprophylaxis following abdominopelvic cancer surgery gives the most protection for the lowest overall cost, a cost analysis showed.
With good patient compliance, low-dose unfractionated heparin after discharge was a better bargain than even daily aspirin at preventing venous thromboembolism (VTE), Dr. Ciaran Bradley reported at a symposium sponsored by the Society of Surgical Oncology.
“Low-dose unfractionated heparin in fact saves money over the currently commonplace practice of doing nothing,” Dr. Bradley said. “It would be cost effective even if compliance with medication were low,” he noted. “Only if the cost of low-molecular-weight heparin were less than $100 would it start to compete for dominance in the model, and currently, it's seven times more expensive than that.”
Aspirin also appears to be an attractive alternative in this clinical situation because of its low cost, oral administration, and absence of heparin-induced thrombocytopenia.
“Even though aspirin has been relatively discounted as a primary agent for thromboprophylaxis for inpatients in the perioperative setting, it may have some utility after the discharge period, and further clinical studies using aspirin for this very scenario may be warranted,” said Dr. Bradley of the Medical College of Wisconsin, Milwaukee.
Patients who undergo abdominopelvic cancer resection are at high risk for VTE, with a postdischarge rate up to 25% reported in one study (BMJ 1988;297:28). Up to 4 weeks of VTE prophylaxis is recommended in guidelines published by the American College of Chest Physicians, National Comprehensive Cancer Network, and American Society of Clinical Oncology, he noted.
“However, we postulate that these guidelines are rarely followed, likely because of concerns over the costs of the agents as a result of bleeding complications and heparin-induced thrombocytopenia, as well as concern that patients may not be compliant with medications because those currently used are injectable formulations,” he said.
Dr. Bradley and his colleagues created a model using a reference case of a patient more than 40 years old who has undergone an open or laparoscopic procedure for abdominopelvic malignancy under general anesthesia and lasting at least 45 minutes. The hypothetical patient received in-hospital chemical prophylaxis for VTE, and was discharged on the seventh postoperative day.
The authors compared the relative costs of four postdischarge thromboprophylaxis strategies: 40 mg of low-molecular-weight heparin given subcutaneously once daily, 5,000 U of low-dose unfractionated heparin given subcutaneously three times daily, 325 mg of aspirin given orally daily, and no prophylaxis. The model assumed a constant risk of VTE and bleeding complications over the 3 weeks after discharge.
The model also assumed that the patient would not always be compliant with dosing. For example, the model assumes that daily compliance with injectable low-molecular-weight heparin would be 79% with once-daily dosing, and that compliance would drop to 65% with injectable low-dose unfractionated heparin dosed three times daily.
Using Medicare and Red Book 2006 data, the authors determined that the cost of VTE would be $4,715, which includes hospitalization plus 6 months of subsequent warfarin therapy and monitoring. Heparin-induced thrombocytopenia would cost $5,184, which includes 5 days of treatment with the thrombin inhibitor lepirudin followed by warfarin for 6 months. Bleeding complications, primarily minor bleeds not requiring treatment but some requiring transfusion, would cost $388.
The cost to patients would be $623 for low-molecular-weight heparin, $72 for low-dose unfractionated heparin, and $2 for aspirin.
But when the researchers factored in the VTE rates associated with each medication in the baseline analysis, they found that low-dose unfractionated heparin was the low-cost leader. The differences would translate into annual population savings relative to no prophylaxis of $50.1 million for low-dose unfractionated heparin and $28.8 million for aspirin, compared with excess costs of $81.3 million for low-molecular-weight heparin.
“This is a great paper,” Dr. Edward A. Levine commented in a postpresentation discussion. “This is something we all wrestle with, since we all work with oncology patients who have more than one risk factor for DVT or VTE,” he said. However, “there are a number of papers that I've seen showing that aspirin doesn't do anything in terms of preventing thromboembolism at all,” noted Dr. Levine, who is chief of surgical oncology at Wake Forest University Baptist Medical Center in Winston-Salem, N.C.
Dr. Bradley agreed that in the inpatient setting, aspirin does not appear to protect against immediate VTEs. “However, some studies have looked at aspirin after the point of discharge, and they do show a benefit, particularly in patients who have an increased VTE risk,” he said.
Dr. Bradley said that he has no relevant financial disclosures.
PHOENIX — Low-dose unfractionated heparin for thromboprophylaxis following abdominopelvic cancer surgery gives the most protection for the lowest overall cost, a cost analysis showed.
With good patient compliance, low-dose unfractionated heparin after discharge was a better bargain than even daily aspirin at preventing venous thromboembolism (VTE), Dr. Ciaran Bradley reported at a symposium sponsored by the Society of Surgical Oncology.
“Low-dose unfractionated heparin in fact saves money over the currently commonplace practice of doing nothing,” Dr. Bradley said. “It would be cost effective even if compliance with medication were low,” he noted. “Only if the cost of low-molecular-weight heparin were less than $100 would it start to compete for dominance in the model, and currently, it's seven times more expensive than that.”
Aspirin also appears to be an attractive alternative in this clinical situation because of its low cost, oral administration, and absence of heparin-induced thrombocytopenia.
“Even though aspirin has been relatively discounted as a primary agent for thromboprophylaxis for inpatients in the perioperative setting, it may have some utility after the discharge period, and further clinical studies using aspirin for this very scenario may be warranted,” said Dr. Bradley of the Medical College of Wisconsin, Milwaukee.
Patients who undergo abdominopelvic cancer resection are at high risk for VTE, with a postdischarge rate up to 25% reported in one study (BMJ 1988;297:28). Up to 4 weeks of VTE prophylaxis is recommended in guidelines published by the American College of Chest Physicians, National Comprehensive Cancer Network, and American Society of Clinical Oncology, he noted.
“However, we postulate that these guidelines are rarely followed, likely because of concerns over the costs of the agents as a result of bleeding complications and heparin-induced thrombocytopenia, as well as concern that patients may not be compliant with medications because those currently used are injectable formulations,” he said.
Dr. Bradley and his colleagues created a model using a reference case of a patient more than 40 years old who has undergone an open or laparoscopic procedure for abdominopelvic malignancy under general anesthesia and lasting at least 45 minutes. The hypothetical patient received in-hospital chemical prophylaxis for VTE, and was discharged on the seventh postoperative day.
The authors compared the relative costs of four postdischarge thromboprophylaxis strategies: 40 mg of low-molecular-weight heparin given subcutaneously once daily, 5,000 U of low-dose unfractionated heparin given subcutaneously three times daily, 325 mg of aspirin given orally daily, and no prophylaxis. The model assumed a constant risk of VTE and bleeding complications over the 3 weeks after discharge.
The model also assumed that the patient would not always be compliant with dosing. For example, the model assumes that daily compliance with injectable low-molecular-weight heparin would be 79% with once-daily dosing, and that compliance would drop to 65% with injectable low-dose unfractionated heparin dosed three times daily.
Using Medicare and Red Book 2006 data, the authors determined that the cost of VTE would be $4,715, which includes hospitalization plus 6 months of subsequent warfarin therapy and monitoring. Heparin-induced thrombocytopenia would cost $5,184, which includes 5 days of treatment with the thrombin inhibitor lepirudin followed by warfarin for 6 months. Bleeding complications, primarily minor bleeds not requiring treatment but some requiring transfusion, would cost $388.
The cost to patients would be $623 for low-molecular-weight heparin, $72 for low-dose unfractionated heparin, and $2 for aspirin.
But when the researchers factored in the VTE rates associated with each medication in the baseline analysis, they found that low-dose unfractionated heparin was the low-cost leader. The differences would translate into annual population savings relative to no prophylaxis of $50.1 million for low-dose unfractionated heparin and $28.8 million for aspirin, compared with excess costs of $81.3 million for low-molecular-weight heparin.
“This is a great paper,” Dr. Edward A. Levine commented in a postpresentation discussion. “This is something we all wrestle with, since we all work with oncology patients who have more than one risk factor for DVT or VTE,” he said. However, “there are a number of papers that I've seen showing that aspirin doesn't do anything in terms of preventing thromboembolism at all,” noted Dr. Levine, who is chief of surgical oncology at Wake Forest University Baptist Medical Center in Winston-Salem, N.C.
Dr. Bradley agreed that in the inpatient setting, aspirin does not appear to protect against immediate VTEs. “However, some studies have looked at aspirin after the point of discharge, and they do show a benefit, particularly in patients who have an increased VTE risk,” he said.
Dr. Bradley said that he has no relevant financial disclosures.
Pancreatectomy Complication Rate Not Higher With Diabetes
CHICAGO — Patients with diabetes mellitus who undergo resection for pancreatic cancer do not have significantly increased risk for delayed gastric emptying, symptomatic fistulae formation, or extended length of hospital stay, compared with nondiabetic patients, data from a retrospective study suggest.
“We are all concerned that diabetics will have more gastric emptying issues, and we might be more likely to put a J [jejunostomy] tube into that patient. Our data suggest rates [of delayed emptying] are not significantly higher,” said Dr. David A. Kooby of the division of surgical oncology, Emory University, Atlanta.
Dr. Kooby was a coauthor of research presented by Dr. Carrie K. Chu at the annual clinical congress of the American College of Surgeons.
To compare 60-day complication rates, they and their associates reviewed the records of 251 patients with pancreatic ductal adenocarcinoma who underwent resection in 2000–2008. Of this group, 116 patients (46%) had preoperative diabetes.
The patients with diabetes were more likely to have at least one comorbidity than were those without diabetes, Dr. Chu said.
The type of pancreatectomy did not differ significantly between groups, nor did hospital length of stay (13–14 days). Most patients underwent pancreaticoduodenectomy. Just 1% of nondiabetic patients had total pancreatectomy, while none of the diabetes patients did. The remainder underwent left pancreatectomy.
There were no dramatic differences in complications by organ system, except for renal dysfunction. A total of 23% of 116 patients with diabetes versus 13% of 135 nondiabetic patients experienced renal dysfunction, “but it was mostly a mild elevation of creatinine,” said Dr. Chu, a surgical resident at Emory.
The 30-day mortality rates were 2.2% in the diabetes mellitus group and 1.7% in the nondiabetic patients, a difference that was not statistically significant, Dr. Chu said.
“The key point is that there was no major difference between diabetics and nondiabetics,” Dr. Kooby said.
CHICAGO — Patients with diabetes mellitus who undergo resection for pancreatic cancer do not have significantly increased risk for delayed gastric emptying, symptomatic fistulae formation, or extended length of hospital stay, compared with nondiabetic patients, data from a retrospective study suggest.
“We are all concerned that diabetics will have more gastric emptying issues, and we might be more likely to put a J [jejunostomy] tube into that patient. Our data suggest rates [of delayed emptying] are not significantly higher,” said Dr. David A. Kooby of the division of surgical oncology, Emory University, Atlanta.
Dr. Kooby was a coauthor of research presented by Dr. Carrie K. Chu at the annual clinical congress of the American College of Surgeons.
To compare 60-day complication rates, they and their associates reviewed the records of 251 patients with pancreatic ductal adenocarcinoma who underwent resection in 2000–2008. Of this group, 116 patients (46%) had preoperative diabetes.
The patients with diabetes were more likely to have at least one comorbidity than were those without diabetes, Dr. Chu said.
The type of pancreatectomy did not differ significantly between groups, nor did hospital length of stay (13–14 days). Most patients underwent pancreaticoduodenectomy. Just 1% of nondiabetic patients had total pancreatectomy, while none of the diabetes patients did. The remainder underwent left pancreatectomy.
There were no dramatic differences in complications by organ system, except for renal dysfunction. A total of 23% of 116 patients with diabetes versus 13% of 135 nondiabetic patients experienced renal dysfunction, “but it was mostly a mild elevation of creatinine,” said Dr. Chu, a surgical resident at Emory.
The 30-day mortality rates were 2.2% in the diabetes mellitus group and 1.7% in the nondiabetic patients, a difference that was not statistically significant, Dr. Chu said.
“The key point is that there was no major difference between diabetics and nondiabetics,” Dr. Kooby said.
CHICAGO — Patients with diabetes mellitus who undergo resection for pancreatic cancer do not have significantly increased risk for delayed gastric emptying, symptomatic fistulae formation, or extended length of hospital stay, compared with nondiabetic patients, data from a retrospective study suggest.
“We are all concerned that diabetics will have more gastric emptying issues, and we might be more likely to put a J [jejunostomy] tube into that patient. Our data suggest rates [of delayed emptying] are not significantly higher,” said Dr. David A. Kooby of the division of surgical oncology, Emory University, Atlanta.
Dr. Kooby was a coauthor of research presented by Dr. Carrie K. Chu at the annual clinical congress of the American College of Surgeons.
To compare 60-day complication rates, they and their associates reviewed the records of 251 patients with pancreatic ductal adenocarcinoma who underwent resection in 2000–2008. Of this group, 116 patients (46%) had preoperative diabetes.
The patients with diabetes were more likely to have at least one comorbidity than were those without diabetes, Dr. Chu said.
The type of pancreatectomy did not differ significantly between groups, nor did hospital length of stay (13–14 days). Most patients underwent pancreaticoduodenectomy. Just 1% of nondiabetic patients had total pancreatectomy, while none of the diabetes patients did. The remainder underwent left pancreatectomy.
There were no dramatic differences in complications by organ system, except for renal dysfunction. A total of 23% of 116 patients with diabetes versus 13% of 135 nondiabetic patients experienced renal dysfunction, “but it was mostly a mild elevation of creatinine,” said Dr. Chu, a surgical resident at Emory.
The 30-day mortality rates were 2.2% in the diabetes mellitus group and 1.7% in the nondiabetic patients, a difference that was not statistically significant, Dr. Chu said.
“The key point is that there was no major difference between diabetics and nondiabetics,” Dr. Kooby said.
FDA Advises Against Anesthetic Joint Infusions
Cases of chondrolysis diagnosed a median of 8.5 months after administration of a continuous intra-articular infusion of a local anesthetic for postsurgical pain with an infusion pump have prompted the Food and Drug Administration to issue a statement recommending against this practice.
“Because the reported cases involved significant injury to otherwise healthy young adults, the FDA wants to advise health care professionals that elastomeric infusion devices or any other infusion pump are not cleared by [the agency] to deliver intra-articular infusions of local anesthetics and should not be used for this purpose,” according to the statement, which lists bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine as the marketed local anesthetics.
The statement also pointed out that local anesthetics are approved as injections “for the production of local or regional anesthesia or analgesia” and are not approved for continuous intra-articular postoperative infusions. “It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years” without any reports of chondrolysis, the statement added.
The 35 reports of chondrolysis—the necrosis and destruction of cartilage—reviewed by the FDA were reported between 2006 and 2008 in people aged 16–58 years (median 25 years), mostly after shoulder surgery; 6 were in people aged 16–18. They were given continuous infusions of a local anesthetic over 48–72 hours, administered directly into the intra-articular space with an elastomeric infusion pump, with and without epinephrine. Of the 35 cases, 34 (97%) involved shoulder surgeries; the remaining case was in the knee. Almost half (46%) of the infusions involved the glenohumeral (glenoid) space. Most of the cases (32 or 91%) involved bupivacaine.
Symptoms of chondrolysis—joint pain, stiffness, and loss of motion—were reported as early as the second month after the infusion. In more than half of the cases, additional surgery, such as arthroscopy or joint replacement, was needed, according to the FDA. The cases were not associated with any single brand of infusion device.
Although the cause of the 35 cases is not known, “the infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis,” the statement said. There have also been recent reports of chondrolysis in the literature of people who have had bupivacaine infusions, as well as preclinical studies that found that exposure of chondrocytes to bupivacaine, lidocaine, and ropivacaine resulted in chondrolysis.
Cases of chondrolysis diagnosed a median of 8.5 months after administration of a continuous intra-articular infusion of a local anesthetic for postsurgical pain with an infusion pump have prompted the Food and Drug Administration to issue a statement recommending against this practice.
“Because the reported cases involved significant injury to otherwise healthy young adults, the FDA wants to advise health care professionals that elastomeric infusion devices or any other infusion pump are not cleared by [the agency] to deliver intra-articular infusions of local anesthetics and should not be used for this purpose,” according to the statement, which lists bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine as the marketed local anesthetics.
The statement also pointed out that local anesthetics are approved as injections “for the production of local or regional anesthesia or analgesia” and are not approved for continuous intra-articular postoperative infusions. “It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years” without any reports of chondrolysis, the statement added.
The 35 reports of chondrolysis—the necrosis and destruction of cartilage—reviewed by the FDA were reported between 2006 and 2008 in people aged 16–58 years (median 25 years), mostly after shoulder surgery; 6 were in people aged 16–18. They were given continuous infusions of a local anesthetic over 48–72 hours, administered directly into the intra-articular space with an elastomeric infusion pump, with and without epinephrine. Of the 35 cases, 34 (97%) involved shoulder surgeries; the remaining case was in the knee. Almost half (46%) of the infusions involved the glenohumeral (glenoid) space. Most of the cases (32 or 91%) involved bupivacaine.
Symptoms of chondrolysis—joint pain, stiffness, and loss of motion—were reported as early as the second month after the infusion. In more than half of the cases, additional surgery, such as arthroscopy or joint replacement, was needed, according to the FDA. The cases were not associated with any single brand of infusion device.
Although the cause of the 35 cases is not known, “the infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis,” the statement said. There have also been recent reports of chondrolysis in the literature of people who have had bupivacaine infusions, as well as preclinical studies that found that exposure of chondrocytes to bupivacaine, lidocaine, and ropivacaine resulted in chondrolysis.
Cases of chondrolysis diagnosed a median of 8.5 months after administration of a continuous intra-articular infusion of a local anesthetic for postsurgical pain with an infusion pump have prompted the Food and Drug Administration to issue a statement recommending against this practice.
“Because the reported cases involved significant injury to otherwise healthy young adults, the FDA wants to advise health care professionals that elastomeric infusion devices or any other infusion pump are not cleared by [the agency] to deliver intra-articular infusions of local anesthetics and should not be used for this purpose,” according to the statement, which lists bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine as the marketed local anesthetics.
The statement also pointed out that local anesthetics are approved as injections “for the production of local or regional anesthesia or analgesia” and are not approved for continuous intra-articular postoperative infusions. “It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years” without any reports of chondrolysis, the statement added.
The 35 reports of chondrolysis—the necrosis and destruction of cartilage—reviewed by the FDA were reported between 2006 and 2008 in people aged 16–58 years (median 25 years), mostly after shoulder surgery; 6 were in people aged 16–18. They were given continuous infusions of a local anesthetic over 48–72 hours, administered directly into the intra-articular space with an elastomeric infusion pump, with and without epinephrine. Of the 35 cases, 34 (97%) involved shoulder surgeries; the remaining case was in the knee. Almost half (46%) of the infusions involved the glenohumeral (glenoid) space. Most of the cases (32 or 91%) involved bupivacaine.
Symptoms of chondrolysis—joint pain, stiffness, and loss of motion—were reported as early as the second month after the infusion. In more than half of the cases, additional surgery, such as arthroscopy or joint replacement, was needed, according to the FDA. The cases were not associated with any single brand of infusion device.
Although the cause of the 35 cases is not known, “the infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis,” the statement said. There have also been recent reports of chondrolysis in the literature of people who have had bupivacaine infusions, as well as preclinical studies that found that exposure of chondrocytes to bupivacaine, lidocaine, and ropivacaine resulted in chondrolysis.
'Surgical Apgar' Score Can Predict Postop Complications
HOLLYWOOD, FLA. — A 10-point scale based on three intraoperative hemodynamic factors accurately predicts which patients undergoing colorectal resection are likely to experience complications after discharge, according to a study of nearly 800 patients.
The traditional Apgar score is a convenient 10-point scale to assess the status of a newborn shortly after birth. Scores 3 and below are regarded as critically low, 4–6 are fairly low, and 7–10 are normal.
A “surgical Apgar” score can calculate a patient's condition following general or vascular surgery and grade the chances of major complications or death. Among the advantages of using a surgical Apgar score are immediate feedback, no cost, and little effort, Dr. Scott E. Regenbogen said. A patient's score is computed in the operating room using estimated blood loss, lowest mean arterial pressure, and lowest heart rate. (See box.)
“We are looking for opportunities to improve outcomes,” Dr. Regenbogen said in an interview at his poster during the annual meeting of the American Society of Colon and Rectal Surgeons.
He and his associates assessed outcomes after 795 colorectal resections over 4 years at Massachusetts General Hospital in Boston. The likelihood of complications after discharge quadrupled among patients with an operating room score between 0 and 4 (relative risk, 4.5), compared with a reference group that had scores of 7 or 8. “So information in the OR still gives us valuable information on how they do even after they leave the hospital,” said Dr. Regenbogen, of Massachusetts General Hospital.
The likelihood of complications after discharge also was higher for patients who scored 5 or 6 (RR, 2.6) but lower for those who scored the highest, a 9 or 10 (RR, 0.6).
There were 49 patients in the 0–4 score group, 186 patients in the 5–6 group, 406 patients in the reference 7–8 group, and 154 in the 9–10 group. The complication rates were 24% for the lowest scoring group, 14% for the 5–6 score group, 5% for the reference group, and 3% among those who scored the highest in the operating room.
The researchers used data from the American College of Surgeons National Surgical Quality Improvement Program database at Massachusetts General Hospital and the institution's Anesthesia Information Management System.
Previous studies validated the score's significant associations with complications in the immediate postoperative period and for other procedures, he said.
For example, a study of 4,119 general and vascular procedures at Mass General and Brigham and Women's Hospital, also in Boston, showed that the score significantly predicts in-hospital postoperative complications (Ann. Surg. 2008;248:320–8). A patient who scored a 7 or 8 in the operating room had no significant change, compared with preoperative risk variables (likelihood ratio, 1.05). In contrast, a score of 0–4 nearly tripled the odds of a major complication within 30 days (LR, 2.80). Again, the best outcomes were associated with a score of 9 or 10 (LR, 0.52).
Dr. Regenbogen had no conflicts of interest to declare.
Source ELSEVIER GLOBAL MEDICAL NEWS
HOLLYWOOD, FLA. — A 10-point scale based on three intraoperative hemodynamic factors accurately predicts which patients undergoing colorectal resection are likely to experience complications after discharge, according to a study of nearly 800 patients.
The traditional Apgar score is a convenient 10-point scale to assess the status of a newborn shortly after birth. Scores 3 and below are regarded as critically low, 4–6 are fairly low, and 7–10 are normal.
A “surgical Apgar” score can calculate a patient's condition following general or vascular surgery and grade the chances of major complications or death. Among the advantages of using a surgical Apgar score are immediate feedback, no cost, and little effort, Dr. Scott E. Regenbogen said. A patient's score is computed in the operating room using estimated blood loss, lowest mean arterial pressure, and lowest heart rate. (See box.)
“We are looking for opportunities to improve outcomes,” Dr. Regenbogen said in an interview at his poster during the annual meeting of the American Society of Colon and Rectal Surgeons.
He and his associates assessed outcomes after 795 colorectal resections over 4 years at Massachusetts General Hospital in Boston. The likelihood of complications after discharge quadrupled among patients with an operating room score between 0 and 4 (relative risk, 4.5), compared with a reference group that had scores of 7 or 8. “So information in the OR still gives us valuable information on how they do even after they leave the hospital,” said Dr. Regenbogen, of Massachusetts General Hospital.
The likelihood of complications after discharge also was higher for patients who scored 5 or 6 (RR, 2.6) but lower for those who scored the highest, a 9 or 10 (RR, 0.6).
There were 49 patients in the 0–4 score group, 186 patients in the 5–6 group, 406 patients in the reference 7–8 group, and 154 in the 9–10 group. The complication rates were 24% for the lowest scoring group, 14% for the 5–6 score group, 5% for the reference group, and 3% among those who scored the highest in the operating room.
The researchers used data from the American College of Surgeons National Surgical Quality Improvement Program database at Massachusetts General Hospital and the institution's Anesthesia Information Management System.
Previous studies validated the score's significant associations with complications in the immediate postoperative period and for other procedures, he said.
For example, a study of 4,119 general and vascular procedures at Mass General and Brigham and Women's Hospital, also in Boston, showed that the score significantly predicts in-hospital postoperative complications (Ann. Surg. 2008;248:320–8). A patient who scored a 7 or 8 in the operating room had no significant change, compared with preoperative risk variables (likelihood ratio, 1.05). In contrast, a score of 0–4 nearly tripled the odds of a major complication within 30 days (LR, 2.80). Again, the best outcomes were associated with a score of 9 or 10 (LR, 0.52).
Dr. Regenbogen had no conflicts of interest to declare.
Source ELSEVIER GLOBAL MEDICAL NEWS
HOLLYWOOD, FLA. — A 10-point scale based on three intraoperative hemodynamic factors accurately predicts which patients undergoing colorectal resection are likely to experience complications after discharge, according to a study of nearly 800 patients.
The traditional Apgar score is a convenient 10-point scale to assess the status of a newborn shortly after birth. Scores 3 and below are regarded as critically low, 4–6 are fairly low, and 7–10 are normal.
A “surgical Apgar” score can calculate a patient's condition following general or vascular surgery and grade the chances of major complications or death. Among the advantages of using a surgical Apgar score are immediate feedback, no cost, and little effort, Dr. Scott E. Regenbogen said. A patient's score is computed in the operating room using estimated blood loss, lowest mean arterial pressure, and lowest heart rate. (See box.)
“We are looking for opportunities to improve outcomes,” Dr. Regenbogen said in an interview at his poster during the annual meeting of the American Society of Colon and Rectal Surgeons.
He and his associates assessed outcomes after 795 colorectal resections over 4 years at Massachusetts General Hospital in Boston. The likelihood of complications after discharge quadrupled among patients with an operating room score between 0 and 4 (relative risk, 4.5), compared with a reference group that had scores of 7 or 8. “So information in the OR still gives us valuable information on how they do even after they leave the hospital,” said Dr. Regenbogen, of Massachusetts General Hospital.
The likelihood of complications after discharge also was higher for patients who scored 5 or 6 (RR, 2.6) but lower for those who scored the highest, a 9 or 10 (RR, 0.6).
There were 49 patients in the 0–4 score group, 186 patients in the 5–6 group, 406 patients in the reference 7–8 group, and 154 in the 9–10 group. The complication rates were 24% for the lowest scoring group, 14% for the 5–6 score group, 5% for the reference group, and 3% among those who scored the highest in the operating room.
The researchers used data from the American College of Surgeons National Surgical Quality Improvement Program database at Massachusetts General Hospital and the institution's Anesthesia Information Management System.
Previous studies validated the score's significant associations with complications in the immediate postoperative period and for other procedures, he said.
For example, a study of 4,119 general and vascular procedures at Mass General and Brigham and Women's Hospital, also in Boston, showed that the score significantly predicts in-hospital postoperative complications (Ann. Surg. 2008;248:320–8). A patient who scored a 7 or 8 in the operating room had no significant change, compared with preoperative risk variables (likelihood ratio, 1.05). In contrast, a score of 0–4 nearly tripled the odds of a major complication within 30 days (LR, 2.80). Again, the best outcomes were associated with a score of 9 or 10 (LR, 0.52).
Dr. Regenbogen had no conflicts of interest to declare.
Source ELSEVIER GLOBAL MEDICAL NEWS