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Hold immunomodulators for surgery? ... Maybe
SCOTTSDALE, ARIZ. – When patients on immunosuppressive therapies need surgery, the risks of disease flare and compromised postoperative recovery and rehabilitation must be weighed against the risk of increased infections and impaired wound healing.
"I’m not sure that there is necessarily a right answer, but I think most people would stop biologic [agents] beforehand," Dr. Paul Grant said at a meeting on perioperative medicine sponsored by the University of Miami.
The decision whether to suspend a disease-modifying antirheumatic drug before surgery may depend on the individual drug and on the patient, said Dr. Grant, director of perioperative and consultative medicine at the University of Michigan Health System in Ann Arbor.
'If someone's taking prednisone every day, make sure they take at least that dose on the day of surgery.'
For example, it appears to be safe for patients on methotrexate to continue on therapy during elective orthopedic surgery. Evidence for this comes from a randomized clinical trial in which patients with rheumatoid arthritis (RA) were assigned to either continue on methotrexate (MTX) or suspend taking it for 2 weeks before and 2 weeks after surgery. The study also contained a control of patients with RA who were not on MTX (Ann. Rheum. Dis. 2001;60:214-7).
The investigators found that there were no significant differences in early complication rates or in complications up to 1 year of follow-up between patients who suspended or remained on MTX. Patients who stayed on the drug had significantly lower rates of RA flare.
Two systematic reviews also looked at the question. One review of eight studies echoes the findings of the aforementioned randomized trial (Clin. Exp. Rheumatol. 2009; 27:856-62), while the other review of four studies concluded that "continued MTX therapy appears to be safe perioperatively and seems also to be associated with a reduced risk of flares" (Clin. Rheumatol. 2008; 27:1217-20). None of the examined papers addressed the issue of safety in connection with comorbidities, age, or high doses of methotrexate.
"The bottom line here is that methotrexate should be continued for most surgeries. I think it might be reasonable to hold it in certain situations, for example if the patient has pretty bad kidney or liver disease, or if it’s surgery to treat a major infection," Dr. Grant said.
TNF-alpha antagonists
In contrast, the data on tumor necrosis factor–alpha (TNF-alpha) antagonists are fuzzier, with limited and conflicting information on perioperative use of these agents (etanercept, infliximab, adalimumab, certolizumab, golimumab).
"The major concern with these drugs is infection," Dr. Grant said. He pointed to a meta-analysis published in JAMA in 2006, which showed that taking the drugs doubled the risk of serious infections in general. The study did not specifically look at perioperative use of TNF-alpha antagonists (JAMA 2006;295:2275-85).
A retrospective cohort study of 127 patients with RA who were undergoing various orthopedic procedures found that there were no differences in surgical site infections but more cases of wound dehiscence in patients who continued on the drugs, compared with those who interrupted their use perioperatively (Clin. Exp. Rheumatol. 2007;25:430-6).
A second, prospective study in 31 patients with RA undergoing foot/ankle surgery found that there were no significant differences in infection or healing between patients who interrupted therapy and those who did not (Foot Ankle Clin. 2007;12:509-24).
Other studies and systematic reviews in patients with RA or Crohn’s disease generally found no significant differences in serious infection rates, but they did detect a higher incidence of skin and soft-tissue infections among patients on anti-TNF-alpha agents vs. other disease-modifying antirheumatic drugs.
The risk of infections tends to be highest at the start of therapy with a TNF-alpha antagonist, and stopping therapy is more likely to result in RA flares among patients with established disease, compared with those in the early stages of RA. Therefore, TNF-blocker therapy should be restarted as soon as possible after surgery to prevent flare, Dr. Grant said.
The American College of Rheumatology and British Society of Rheumatology recommend holding TNF-alpha antagonists for one dosing cycle before major surgery. For etanercept (Enbrel), that translates to a 1-week before surgery hold, for infliximab (Remicade) 6-8 weeks, and for adalimumab (Humira) 2 weeks. These agents should also be held for 10-14 days after surgery or until wound healing is satisfactory.
"It’s probably safe to continue these medications for minor surgeries," Dr. Grant said.
Other agents
The anti-CD20 agent rituximab (Rituxan) – currently used to treat RA, vasculitis, hematologic malignancies, and other conditions – has a lower risk for bacterial infections than do TNF-alpha antagonists and has been shown to be safe in patients with a history of recurrent bacterial infections.
"Hydroxychloroquine (or Plaquenil) is felt to be safe during the preoperative period. It is recommended to continue this medication without stopping," Dr. Grant said.
There is conflicting information on infection risk with the use leflunomide (Arava), but it may be wise to stop therapy 2-4 weeks before nonurgent surgery in higher-risk patients.
There is consensus that sulfasalazine (Azulfidine) and azathioprine (Imuran) can be safely continued perioperatively, he said, although some advise holding sulfasalazine on the day of surgery.
Regarding perioperative steroids, Dr. Grant recommended determining the patient’s steroid exposure over the past year.
"Stress dose steroids are not routinely needed as long as the patients continue their normal dose.
"That’s really the important piece: If someone’s taking prednisone every day, make sure they take at least that dose on the day of surgery," he said.
Dr. Lary Robinson, FCCP, comments: Surgeons are rightfully concerned about the preoperative use of any medicines that might increase the risk of bleeding, infections or wound healing. The topic of immunomodulating drugs was explored by evaluating the published evidence about their safety in the perioperative period. These agents, used in patients with autoimmune/inflammatory diseases such as rheumatoid arthritis and Crohn's disease, are generally safe to continue although most authorities generally recommend holding the TNF-alpha antagonists prior to and after major surgery due to potential wound healing and infectious problems.
SCOTTSDALE, ARIZ. – When patients on immunosuppressive therapies need surgery, the risks of disease flare and compromised postoperative recovery and rehabilitation must be weighed against the risk of increased infections and impaired wound healing.
"I’m not sure that there is necessarily a right answer, but I think most people would stop biologic [agents] beforehand," Dr. Paul Grant said at a meeting on perioperative medicine sponsored by the University of Miami.
The decision whether to suspend a disease-modifying antirheumatic drug before surgery may depend on the individual drug and on the patient, said Dr. Grant, director of perioperative and consultative medicine at the University of Michigan Health System in Ann Arbor.
'If someone's taking prednisone every day, make sure they take at least that dose on the day of surgery.'
For example, it appears to be safe for patients on methotrexate to continue on therapy during elective orthopedic surgery. Evidence for this comes from a randomized clinical trial in which patients with rheumatoid arthritis (RA) were assigned to either continue on methotrexate (MTX) or suspend taking it for 2 weeks before and 2 weeks after surgery. The study also contained a control of patients with RA who were not on MTX (Ann. Rheum. Dis. 2001;60:214-7).
The investigators found that there were no significant differences in early complication rates or in complications up to 1 year of follow-up between patients who suspended or remained on MTX. Patients who stayed on the drug had significantly lower rates of RA flare.
Two systematic reviews also looked at the question. One review of eight studies echoes the findings of the aforementioned randomized trial (Clin. Exp. Rheumatol. 2009; 27:856-62), while the other review of four studies concluded that "continued MTX therapy appears to be safe perioperatively and seems also to be associated with a reduced risk of flares" (Clin. Rheumatol. 2008; 27:1217-20). None of the examined papers addressed the issue of safety in connection with comorbidities, age, or high doses of methotrexate.
"The bottom line here is that methotrexate should be continued for most surgeries. I think it might be reasonable to hold it in certain situations, for example if the patient has pretty bad kidney or liver disease, or if it’s surgery to treat a major infection," Dr. Grant said.
TNF-alpha antagonists
In contrast, the data on tumor necrosis factor–alpha (TNF-alpha) antagonists are fuzzier, with limited and conflicting information on perioperative use of these agents (etanercept, infliximab, adalimumab, certolizumab, golimumab).
"The major concern with these drugs is infection," Dr. Grant said. He pointed to a meta-analysis published in JAMA in 2006, which showed that taking the drugs doubled the risk of serious infections in general. The study did not specifically look at perioperative use of TNF-alpha antagonists (JAMA 2006;295:2275-85).
A retrospective cohort study of 127 patients with RA who were undergoing various orthopedic procedures found that there were no differences in surgical site infections but more cases of wound dehiscence in patients who continued on the drugs, compared with those who interrupted their use perioperatively (Clin. Exp. Rheumatol. 2007;25:430-6).
A second, prospective study in 31 patients with RA undergoing foot/ankle surgery found that there were no significant differences in infection or healing between patients who interrupted therapy and those who did not (Foot Ankle Clin. 2007;12:509-24).
Other studies and systematic reviews in patients with RA or Crohn’s disease generally found no significant differences in serious infection rates, but they did detect a higher incidence of skin and soft-tissue infections among patients on anti-TNF-alpha agents vs. other disease-modifying antirheumatic drugs.
The risk of infections tends to be highest at the start of therapy with a TNF-alpha antagonist, and stopping therapy is more likely to result in RA flares among patients with established disease, compared with those in the early stages of RA. Therefore, TNF-blocker therapy should be restarted as soon as possible after surgery to prevent flare, Dr. Grant said.
The American College of Rheumatology and British Society of Rheumatology recommend holding TNF-alpha antagonists for one dosing cycle before major surgery. For etanercept (Enbrel), that translates to a 1-week before surgery hold, for infliximab (Remicade) 6-8 weeks, and for adalimumab (Humira) 2 weeks. These agents should also be held for 10-14 days after surgery or until wound healing is satisfactory.
"It’s probably safe to continue these medications for minor surgeries," Dr. Grant said.
Other agents
The anti-CD20 agent rituximab (Rituxan) – currently used to treat RA, vasculitis, hematologic malignancies, and other conditions – has a lower risk for bacterial infections than do TNF-alpha antagonists and has been shown to be safe in patients with a history of recurrent bacterial infections.
"Hydroxychloroquine (or Plaquenil) is felt to be safe during the preoperative period. It is recommended to continue this medication without stopping," Dr. Grant said.
There is conflicting information on infection risk with the use leflunomide (Arava), but it may be wise to stop therapy 2-4 weeks before nonurgent surgery in higher-risk patients.
There is consensus that sulfasalazine (Azulfidine) and azathioprine (Imuran) can be safely continued perioperatively, he said, although some advise holding sulfasalazine on the day of surgery.
Regarding perioperative steroids, Dr. Grant recommended determining the patient’s steroid exposure over the past year.
"Stress dose steroids are not routinely needed as long as the patients continue their normal dose.
"That’s really the important piece: If someone’s taking prednisone every day, make sure they take at least that dose on the day of surgery," he said.
Dr. Lary Robinson, FCCP, comments: Surgeons are rightfully concerned about the preoperative use of any medicines that might increase the risk of bleeding, infections or wound healing. The topic of immunomodulating drugs was explored by evaluating the published evidence about their safety in the perioperative period. These agents, used in patients with autoimmune/inflammatory diseases such as rheumatoid arthritis and Crohn's disease, are generally safe to continue although most authorities generally recommend holding the TNF-alpha antagonists prior to and after major surgery due to potential wound healing and infectious problems.
SCOTTSDALE, ARIZ. – When patients on immunosuppressive therapies need surgery, the risks of disease flare and compromised postoperative recovery and rehabilitation must be weighed against the risk of increased infections and impaired wound healing.
"I’m not sure that there is necessarily a right answer, but I think most people would stop biologic [agents] beforehand," Dr. Paul Grant said at a meeting on perioperative medicine sponsored by the University of Miami.
The decision whether to suspend a disease-modifying antirheumatic drug before surgery may depend on the individual drug and on the patient, said Dr. Grant, director of perioperative and consultative medicine at the University of Michigan Health System in Ann Arbor.
'If someone's taking prednisone every day, make sure they take at least that dose on the day of surgery.'
For example, it appears to be safe for patients on methotrexate to continue on therapy during elective orthopedic surgery. Evidence for this comes from a randomized clinical trial in which patients with rheumatoid arthritis (RA) were assigned to either continue on methotrexate (MTX) or suspend taking it for 2 weeks before and 2 weeks after surgery. The study also contained a control of patients with RA who were not on MTX (Ann. Rheum. Dis. 2001;60:214-7).
The investigators found that there were no significant differences in early complication rates or in complications up to 1 year of follow-up between patients who suspended or remained on MTX. Patients who stayed on the drug had significantly lower rates of RA flare.
Two systematic reviews also looked at the question. One review of eight studies echoes the findings of the aforementioned randomized trial (Clin. Exp. Rheumatol. 2009; 27:856-62), while the other review of four studies concluded that "continued MTX therapy appears to be safe perioperatively and seems also to be associated with a reduced risk of flares" (Clin. Rheumatol. 2008; 27:1217-20). None of the examined papers addressed the issue of safety in connection with comorbidities, age, or high doses of methotrexate.
"The bottom line here is that methotrexate should be continued for most surgeries. I think it might be reasonable to hold it in certain situations, for example if the patient has pretty bad kidney or liver disease, or if it’s surgery to treat a major infection," Dr. Grant said.
TNF-alpha antagonists
In contrast, the data on tumor necrosis factor–alpha (TNF-alpha) antagonists are fuzzier, with limited and conflicting information on perioperative use of these agents (etanercept, infliximab, adalimumab, certolizumab, golimumab).
"The major concern with these drugs is infection," Dr. Grant said. He pointed to a meta-analysis published in JAMA in 2006, which showed that taking the drugs doubled the risk of serious infections in general. The study did not specifically look at perioperative use of TNF-alpha antagonists (JAMA 2006;295:2275-85).
A retrospective cohort study of 127 patients with RA who were undergoing various orthopedic procedures found that there were no differences in surgical site infections but more cases of wound dehiscence in patients who continued on the drugs, compared with those who interrupted their use perioperatively (Clin. Exp. Rheumatol. 2007;25:430-6).
A second, prospective study in 31 patients with RA undergoing foot/ankle surgery found that there were no significant differences in infection or healing between patients who interrupted therapy and those who did not (Foot Ankle Clin. 2007;12:509-24).
Other studies and systematic reviews in patients with RA or Crohn’s disease generally found no significant differences in serious infection rates, but they did detect a higher incidence of skin and soft-tissue infections among patients on anti-TNF-alpha agents vs. other disease-modifying antirheumatic drugs.
The risk of infections tends to be highest at the start of therapy with a TNF-alpha antagonist, and stopping therapy is more likely to result in RA flares among patients with established disease, compared with those in the early stages of RA. Therefore, TNF-blocker therapy should be restarted as soon as possible after surgery to prevent flare, Dr. Grant said.
The American College of Rheumatology and British Society of Rheumatology recommend holding TNF-alpha antagonists for one dosing cycle before major surgery. For etanercept (Enbrel), that translates to a 1-week before surgery hold, for infliximab (Remicade) 6-8 weeks, and for adalimumab (Humira) 2 weeks. These agents should also be held for 10-14 days after surgery or until wound healing is satisfactory.
"It’s probably safe to continue these medications for minor surgeries," Dr. Grant said.
Other agents
The anti-CD20 agent rituximab (Rituxan) – currently used to treat RA, vasculitis, hematologic malignancies, and other conditions – has a lower risk for bacterial infections than do TNF-alpha antagonists and has been shown to be safe in patients with a history of recurrent bacterial infections.
"Hydroxychloroquine (or Plaquenil) is felt to be safe during the preoperative period. It is recommended to continue this medication without stopping," Dr. Grant said.
There is conflicting information on infection risk with the use leflunomide (Arava), but it may be wise to stop therapy 2-4 weeks before nonurgent surgery in higher-risk patients.
There is consensus that sulfasalazine (Azulfidine) and azathioprine (Imuran) can be safely continued perioperatively, he said, although some advise holding sulfasalazine on the day of surgery.
Regarding perioperative steroids, Dr. Grant recommended determining the patient’s steroid exposure over the past year.
"Stress dose steroids are not routinely needed as long as the patients continue their normal dose.
"That’s really the important piece: If someone’s taking prednisone every day, make sure they take at least that dose on the day of surgery," he said.
Dr. Lary Robinson, FCCP, comments: Surgeons are rightfully concerned about the preoperative use of any medicines that might increase the risk of bleeding, infections or wound healing. The topic of immunomodulating drugs was explored by evaluating the published evidence about their safety in the perioperative period. These agents, used in patients with autoimmune/inflammatory diseases such as rheumatoid arthritis and Crohn's disease, are generally safe to continue although most authorities generally recommend holding the TNF-alpha antagonists prior to and after major surgery due to potential wound healing and infectious problems.
Major finding: Some immunomodulating agents for inflammatory and autoimmune diseases can be safely continued during the perioperative period.
Data source: A review of evidence on the use of various immunomodulators.
Disclosures: Dr. Grant reported having no financial disclosures.
VIDEO: Rethink the VTE prophylaxis mantra
LAS VEGAS – Venous thromboembolism prophylaxis – a sine qua non of the Joint Commission and others – doesn’t seem to prevent deep vein thrombosis or pulmonary embolism in hospitalized medical patients, but it does make them more likely to bleed, according to investigators from the Michigan Hospital Medicine Safety Consortium.
The findings are prompting one of those investigators to reassess his own approach. In an interview at the Society of Hospital Medicine’s 2014 meeting, Dr. Scott Kaatz, chief quality officer at Hurley Medical Center in Flint, Mich., told us how he’s thinking a bit differently these days when it comes to VTE prophylaxis in medical inpatients.
LAS VEGAS – Venous thromboembolism prophylaxis – a sine qua non of the Joint Commission and others – doesn’t seem to prevent deep vein thrombosis or pulmonary embolism in hospitalized medical patients, but it does make them more likely to bleed, according to investigators from the Michigan Hospital Medicine Safety Consortium.
The findings are prompting one of those investigators to reassess his own approach. In an interview at the Society of Hospital Medicine’s 2014 meeting, Dr. Scott Kaatz, chief quality officer at Hurley Medical Center in Flint, Mich., told us how he’s thinking a bit differently these days when it comes to VTE prophylaxis in medical inpatients.
LAS VEGAS – Venous thromboembolism prophylaxis – a sine qua non of the Joint Commission and others – doesn’t seem to prevent deep vein thrombosis or pulmonary embolism in hospitalized medical patients, but it does make them more likely to bleed, according to investigators from the Michigan Hospital Medicine Safety Consortium.
The findings are prompting one of those investigators to reassess his own approach. In an interview at the Society of Hospital Medicine’s 2014 meeting, Dr. Scott Kaatz, chief quality officer at Hurley Medical Center in Flint, Mich., told us how he’s thinking a bit differently these days when it comes to VTE prophylaxis in medical inpatients.
AT HOSPITAL MEDICINE 2014
Lung transplants in HIV-positive gaining momentum
MADRID – Evidence is mounting that lung transplantation is feasible in highly select patients positive for human immunodeficiency virus.
A retrospective analysis of three patients revealed no long-term resurgence of HIV viremia or profound complications of overt immune suppression. CD4 counts decreased initially in one patient, but recovered after about 1 year with antiretroviral therapy (ART). All patients were adequately controlled on combination ART, had no HIV viremia for 2 years prior to surgery, and had no resistance to standard antiretrovirals.
"Not all HIV-positive patients would be candidates," Dr. Harish Seethamraju said during a late-breaking abstract session at the world congress of the American College of Chest Physicians. "You want to ensure compliance; and an ability to manage complex medication regimens would be the challenge for any person. So, people who have an in-depth knowledge about their disease and are able to manage their HIV well for a prolonged period of time would be ideal candidates."
As with other solid-organ transplants, acute rejection remains a concern and was reported in patient 1, who underwent bilateral transplant for HIV-associated pulmonary arterial hypertension. The patient experienced three episodes of rejection, including bronchiolitis obliterans syndrome and rejection with respiratory syncytial virus pneumonia requiring admission at 15 months, which tipped her course dramatically and resulted in loss of most of her lung function by post-transplant 43 months, he said.
Mild acute rejection occurred in patients 2 and 3, who were transplanted for idiopathic pulmonary fibrosis, but they remain free of acute rejection and are actively employed 15 months and 41 months after transplant.
Surgeons at Houston Methodist Hospital and the University of California, San Francisco, where the transplants were performed, also learned that ART has to be initiated very early on post-transplant, said Dr. Seethamraju, now medical director of the lung transplant program, University of Kentucky, Lexington.
"In patient 2, we found a resurgence of HIV viremia within 10 days, but we just stopped the medication for the first 4 days and that’s all it took for the virus to come back," he said.
The study findings should provide guidance for clinicians considering transplantation in the wake of the recently approved HIV Organ Policy Equity (HOPE) Act, which made it legal in the United States now to transplant HIV-positive organs in HIV-positive patients. HIV patients are often referred for lung transplant because of an increased incidence of pulmonary hypertension and infections, but their HIV status has traditionally been taken as a contraindication due to the potential risks of added immunosuppression, said Dr. Seethamraju. Only one case report has been published of an HIV and hepatitis B virus coinfected patient with cystic fibrosis who underwent successful double lung transplant, he said.
During a discussion of the study, CHEST Congress cochair Dr. Joan Soriano, of Hospital Universitari Son Espases, Palma de Mallorca, Spain, asked whether any of the centers would consider lung transplantation in HIV-positive patients with chronic obstructive pulmonary disease (COPD).
Dr. Seethamraju replied that COPD is the second-most-common indication for transplant after idiopathic pulmonary fibrosis and interstitial lung disease, but that the United Network for Organ Sharing 2005 lung allocation scores are very low for COPD patients, and thus organs would be hard to obtain for this specific group of HIV patients. "But it would be a great candidate for us," he added. "We would definitely do a transplant in that group of patients, irrespective of their HIV status."
Dr. Seethamraju and his coauthors reported no relevant disclosures.
MADRID – Evidence is mounting that lung transplantation is feasible in highly select patients positive for human immunodeficiency virus.
A retrospective analysis of three patients revealed no long-term resurgence of HIV viremia or profound complications of overt immune suppression. CD4 counts decreased initially in one patient, but recovered after about 1 year with antiretroviral therapy (ART). All patients were adequately controlled on combination ART, had no HIV viremia for 2 years prior to surgery, and had no resistance to standard antiretrovirals.
"Not all HIV-positive patients would be candidates," Dr. Harish Seethamraju said during a late-breaking abstract session at the world congress of the American College of Chest Physicians. "You want to ensure compliance; and an ability to manage complex medication regimens would be the challenge for any person. So, people who have an in-depth knowledge about their disease and are able to manage their HIV well for a prolonged period of time would be ideal candidates."
As with other solid-organ transplants, acute rejection remains a concern and was reported in patient 1, who underwent bilateral transplant for HIV-associated pulmonary arterial hypertension. The patient experienced three episodes of rejection, including bronchiolitis obliterans syndrome and rejection with respiratory syncytial virus pneumonia requiring admission at 15 months, which tipped her course dramatically and resulted in loss of most of her lung function by post-transplant 43 months, he said.
Mild acute rejection occurred in patients 2 and 3, who were transplanted for idiopathic pulmonary fibrosis, but they remain free of acute rejection and are actively employed 15 months and 41 months after transplant.
Surgeons at Houston Methodist Hospital and the University of California, San Francisco, where the transplants were performed, also learned that ART has to be initiated very early on post-transplant, said Dr. Seethamraju, now medical director of the lung transplant program, University of Kentucky, Lexington.
"In patient 2, we found a resurgence of HIV viremia within 10 days, but we just stopped the medication for the first 4 days and that’s all it took for the virus to come back," he said.
The study findings should provide guidance for clinicians considering transplantation in the wake of the recently approved HIV Organ Policy Equity (HOPE) Act, which made it legal in the United States now to transplant HIV-positive organs in HIV-positive patients. HIV patients are often referred for lung transplant because of an increased incidence of pulmonary hypertension and infections, but their HIV status has traditionally been taken as a contraindication due to the potential risks of added immunosuppression, said Dr. Seethamraju. Only one case report has been published of an HIV and hepatitis B virus coinfected patient with cystic fibrosis who underwent successful double lung transplant, he said.
During a discussion of the study, CHEST Congress cochair Dr. Joan Soriano, of Hospital Universitari Son Espases, Palma de Mallorca, Spain, asked whether any of the centers would consider lung transplantation in HIV-positive patients with chronic obstructive pulmonary disease (COPD).
Dr. Seethamraju replied that COPD is the second-most-common indication for transplant after idiopathic pulmonary fibrosis and interstitial lung disease, but that the United Network for Organ Sharing 2005 lung allocation scores are very low for COPD patients, and thus organs would be hard to obtain for this specific group of HIV patients. "But it would be a great candidate for us," he added. "We would definitely do a transplant in that group of patients, irrespective of their HIV status."
Dr. Seethamraju and his coauthors reported no relevant disclosures.
MADRID – Evidence is mounting that lung transplantation is feasible in highly select patients positive for human immunodeficiency virus.
A retrospective analysis of three patients revealed no long-term resurgence of HIV viremia or profound complications of overt immune suppression. CD4 counts decreased initially in one patient, but recovered after about 1 year with antiretroviral therapy (ART). All patients were adequately controlled on combination ART, had no HIV viremia for 2 years prior to surgery, and had no resistance to standard antiretrovirals.
"Not all HIV-positive patients would be candidates," Dr. Harish Seethamraju said during a late-breaking abstract session at the world congress of the American College of Chest Physicians. "You want to ensure compliance; and an ability to manage complex medication regimens would be the challenge for any person. So, people who have an in-depth knowledge about their disease and are able to manage their HIV well for a prolonged period of time would be ideal candidates."
As with other solid-organ transplants, acute rejection remains a concern and was reported in patient 1, who underwent bilateral transplant for HIV-associated pulmonary arterial hypertension. The patient experienced three episodes of rejection, including bronchiolitis obliterans syndrome and rejection with respiratory syncytial virus pneumonia requiring admission at 15 months, which tipped her course dramatically and resulted in loss of most of her lung function by post-transplant 43 months, he said.
Mild acute rejection occurred in patients 2 and 3, who were transplanted for idiopathic pulmonary fibrosis, but they remain free of acute rejection and are actively employed 15 months and 41 months after transplant.
Surgeons at Houston Methodist Hospital and the University of California, San Francisco, where the transplants were performed, also learned that ART has to be initiated very early on post-transplant, said Dr. Seethamraju, now medical director of the lung transplant program, University of Kentucky, Lexington.
"In patient 2, we found a resurgence of HIV viremia within 10 days, but we just stopped the medication for the first 4 days and that’s all it took for the virus to come back," he said.
The study findings should provide guidance for clinicians considering transplantation in the wake of the recently approved HIV Organ Policy Equity (HOPE) Act, which made it legal in the United States now to transplant HIV-positive organs in HIV-positive patients. HIV patients are often referred for lung transplant because of an increased incidence of pulmonary hypertension and infections, but their HIV status has traditionally been taken as a contraindication due to the potential risks of added immunosuppression, said Dr. Seethamraju. Only one case report has been published of an HIV and hepatitis B virus coinfected patient with cystic fibrosis who underwent successful double lung transplant, he said.
During a discussion of the study, CHEST Congress cochair Dr. Joan Soriano, of Hospital Universitari Son Espases, Palma de Mallorca, Spain, asked whether any of the centers would consider lung transplantation in HIV-positive patients with chronic obstructive pulmonary disease (COPD).
Dr. Seethamraju replied that COPD is the second-most-common indication for transplant after idiopathic pulmonary fibrosis and interstitial lung disease, but that the United Network for Organ Sharing 2005 lung allocation scores are very low for COPD patients, and thus organs would be hard to obtain for this specific group of HIV patients. "But it would be a great candidate for us," he added. "We would definitely do a transplant in that group of patients, irrespective of their HIV status."
Dr. Seethamraju and his coauthors reported no relevant disclosures.
AT CHEST WORLD CONGRESS 2014
Major finding: Mild acute rejection occurred in two HIV-positive patients who were transplanted for idiopathic pulmonary fibrosis; they have remained free of acute rejection and are actively employed 15 months and 41 months after transplant.
Data source: A retrospective analysis of lung transplantation in three HIV-positive patients.
Disclosures: Dr. Seethamraju and his coauthors reported no relevant disclosures.
Intraoperative steroids found to increase MI risk in cardiac surgery patients
WASHINGTON – Administering methylprednisolone to patients undergoing cardiac surgery with cardiopulmonary bypass did not reduce the risks of death or major morbidity at 30 days, but was associated with an increased risk of early postoperative myocardial infarction, in a randomized controlled trial of about 7,500 high-risk surgical patients.
Based on the results of the study, the Steroids in Cardiac Surgery (SIRS) trial, "methylprednisolone should not be administered prophylactically to high-risk patients undergoing cardiac surgery" with cardiopulmonary bypass, Dr. Richard Whitlock said at the annual meeting of the American College of Cardiology.
SIRS, a randomized controlled study, evaluated the effects of prophylactic steroids in patients undergoing cardiac surgery with cardiopulmonary bypass in 18 countries in North and South America, Europe, the Middle East, and Asia. The study addressed whether the use of prophylactic steroids can attenuate the "intense inflammatory response" that occurs with cardiopulmonary bypass and is associated with adverse outcomes, said Dr. Whitlock, a cardiac surgeon at McMaster University, Hamilton, Ont., and lead investigator in the study.
Whether this approach results in improved outcomes has been unclear, he said. A recent meta-analysis of 44 small studies suggested that steroids have clinical benefits in this setting, and this use of methylprednisolone is standard practice in many European countries. And although it is not used as extensively in the United States, it is still standard care at some U.S. centers, he noted.
In SIRS, patients were randomized to 500 mg methylprednisolone, administered intravenously during surgery (3,755 patients) or placebo (3,752). Patients were considered high risk; their mean age was 67 years, two-thirds were male, and their mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 7.1. Only one patient, who was in the treatment group, was lost to follow-up.
There were no significant differences between the two groups in the two primary endpoints: total mortality at 30 days and the combined endpoint of total mortality, stroke, MI, renal failure, or respiratory failure within 30 days. The results were consistent across different subgroups, including sex, diabetes status, age, EuroSCORE, type of surgery and duration of cardiopulmonary bypass.
However, significantly more patients in the treatment group had an MI – mostly early – after surgery (500 vs. 408 in the placebo group), an increased risk of 22%, which was statistically significant.
The use of methylprednisolone was not associated with an altered risk of other stroke, new renal failure, or respiratory failure, or other outcomes measured, including transfusion requirements, new-onset atrial fibrillation, length of ICU or hospital stay, surgical site infections, delirium, or GI complications, Dr. Whitlock said.
When asked about a possible mechanism behind the SIRS results, Dr. Whitlock said that one possible explanation could be that since one of the important early recovery strategies after myocardial injury is movement of glucose into cells, and insulin requirements increase in the steroid-treated patients, "it is possible that we’re inducing insulin resistance: Thereby, glucose is not entering the myocyte for the recovery phase after the ischemic insult." While that is plausible, he added, "we really don’t have the answer. What is important is the signal is clear, it’s clear across all subgroups, and it is a prognostically important increase."
Dr. Amit Khera, director of the preventive cardiology program at UT Southwestern Medical Center, Dallas, commented that SIRS was a definitive study, and this use of methylprednisolone, at least at higher doses, "should not be a strategy we should pursue."
The SIRS trial was conducted by the Population Health Research Institute at the Hamilton Health Sciences and McMaster University during 2007-2014 and was funded with grants from the Canadian Institutes for Health Research and the Canadian Network and Centre for Trials Internationally. Dr. Whitlock said he had no relevant financial disclosures.
WASHINGTON – Administering methylprednisolone to patients undergoing cardiac surgery with cardiopulmonary bypass did not reduce the risks of death or major morbidity at 30 days, but was associated with an increased risk of early postoperative myocardial infarction, in a randomized controlled trial of about 7,500 high-risk surgical patients.
Based on the results of the study, the Steroids in Cardiac Surgery (SIRS) trial, "methylprednisolone should not be administered prophylactically to high-risk patients undergoing cardiac surgery" with cardiopulmonary bypass, Dr. Richard Whitlock said at the annual meeting of the American College of Cardiology.
SIRS, a randomized controlled study, evaluated the effects of prophylactic steroids in patients undergoing cardiac surgery with cardiopulmonary bypass in 18 countries in North and South America, Europe, the Middle East, and Asia. The study addressed whether the use of prophylactic steroids can attenuate the "intense inflammatory response" that occurs with cardiopulmonary bypass and is associated with adverse outcomes, said Dr. Whitlock, a cardiac surgeon at McMaster University, Hamilton, Ont., and lead investigator in the study.
Whether this approach results in improved outcomes has been unclear, he said. A recent meta-analysis of 44 small studies suggested that steroids have clinical benefits in this setting, and this use of methylprednisolone is standard practice in many European countries. And although it is not used as extensively in the United States, it is still standard care at some U.S. centers, he noted.
In SIRS, patients were randomized to 500 mg methylprednisolone, administered intravenously during surgery (3,755 patients) or placebo (3,752). Patients were considered high risk; their mean age was 67 years, two-thirds were male, and their mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 7.1. Only one patient, who was in the treatment group, was lost to follow-up.
There were no significant differences between the two groups in the two primary endpoints: total mortality at 30 days and the combined endpoint of total mortality, stroke, MI, renal failure, or respiratory failure within 30 days. The results were consistent across different subgroups, including sex, diabetes status, age, EuroSCORE, type of surgery and duration of cardiopulmonary bypass.
However, significantly more patients in the treatment group had an MI – mostly early – after surgery (500 vs. 408 in the placebo group), an increased risk of 22%, which was statistically significant.
The use of methylprednisolone was not associated with an altered risk of other stroke, new renal failure, or respiratory failure, or other outcomes measured, including transfusion requirements, new-onset atrial fibrillation, length of ICU or hospital stay, surgical site infections, delirium, or GI complications, Dr. Whitlock said.
When asked about a possible mechanism behind the SIRS results, Dr. Whitlock said that one possible explanation could be that since one of the important early recovery strategies after myocardial injury is movement of glucose into cells, and insulin requirements increase in the steroid-treated patients, "it is possible that we’re inducing insulin resistance: Thereby, glucose is not entering the myocyte for the recovery phase after the ischemic insult." While that is plausible, he added, "we really don’t have the answer. What is important is the signal is clear, it’s clear across all subgroups, and it is a prognostically important increase."
Dr. Amit Khera, director of the preventive cardiology program at UT Southwestern Medical Center, Dallas, commented that SIRS was a definitive study, and this use of methylprednisolone, at least at higher doses, "should not be a strategy we should pursue."
The SIRS trial was conducted by the Population Health Research Institute at the Hamilton Health Sciences and McMaster University during 2007-2014 and was funded with grants from the Canadian Institutes for Health Research and the Canadian Network and Centre for Trials Internationally. Dr. Whitlock said he had no relevant financial disclosures.
WASHINGTON – Administering methylprednisolone to patients undergoing cardiac surgery with cardiopulmonary bypass did not reduce the risks of death or major morbidity at 30 days, but was associated with an increased risk of early postoperative myocardial infarction, in a randomized controlled trial of about 7,500 high-risk surgical patients.
Based on the results of the study, the Steroids in Cardiac Surgery (SIRS) trial, "methylprednisolone should not be administered prophylactically to high-risk patients undergoing cardiac surgery" with cardiopulmonary bypass, Dr. Richard Whitlock said at the annual meeting of the American College of Cardiology.
SIRS, a randomized controlled study, evaluated the effects of prophylactic steroids in patients undergoing cardiac surgery with cardiopulmonary bypass in 18 countries in North and South America, Europe, the Middle East, and Asia. The study addressed whether the use of prophylactic steroids can attenuate the "intense inflammatory response" that occurs with cardiopulmonary bypass and is associated with adverse outcomes, said Dr. Whitlock, a cardiac surgeon at McMaster University, Hamilton, Ont., and lead investigator in the study.
Whether this approach results in improved outcomes has been unclear, he said. A recent meta-analysis of 44 small studies suggested that steroids have clinical benefits in this setting, and this use of methylprednisolone is standard practice in many European countries. And although it is not used as extensively in the United States, it is still standard care at some U.S. centers, he noted.
In SIRS, patients were randomized to 500 mg methylprednisolone, administered intravenously during surgery (3,755 patients) or placebo (3,752). Patients were considered high risk; their mean age was 67 years, two-thirds were male, and their mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 7.1. Only one patient, who was in the treatment group, was lost to follow-up.
There were no significant differences between the two groups in the two primary endpoints: total mortality at 30 days and the combined endpoint of total mortality, stroke, MI, renal failure, or respiratory failure within 30 days. The results were consistent across different subgroups, including sex, diabetes status, age, EuroSCORE, type of surgery and duration of cardiopulmonary bypass.
However, significantly more patients in the treatment group had an MI – mostly early – after surgery (500 vs. 408 in the placebo group), an increased risk of 22%, which was statistically significant.
The use of methylprednisolone was not associated with an altered risk of other stroke, new renal failure, or respiratory failure, or other outcomes measured, including transfusion requirements, new-onset atrial fibrillation, length of ICU or hospital stay, surgical site infections, delirium, or GI complications, Dr. Whitlock said.
When asked about a possible mechanism behind the SIRS results, Dr. Whitlock said that one possible explanation could be that since one of the important early recovery strategies after myocardial injury is movement of glucose into cells, and insulin requirements increase in the steroid-treated patients, "it is possible that we’re inducing insulin resistance: Thereby, glucose is not entering the myocyte for the recovery phase after the ischemic insult." While that is plausible, he added, "we really don’t have the answer. What is important is the signal is clear, it’s clear across all subgroups, and it is a prognostically important increase."
Dr. Amit Khera, director of the preventive cardiology program at UT Southwestern Medical Center, Dallas, commented that SIRS was a definitive study, and this use of methylprednisolone, at least at higher doses, "should not be a strategy we should pursue."
The SIRS trial was conducted by the Population Health Research Institute at the Hamilton Health Sciences and McMaster University during 2007-2014 and was funded with grants from the Canadian Institutes for Health Research and the Canadian Network and Centre for Trials Internationally. Dr. Whitlock said he had no relevant financial disclosures.
AT ACC 14
Major finding: Intraoperative methylprednisolone had no prophylactic effect in reducing mortality or serious morbidity, but was associated with a 22% increased risk of early postoperative MI, in high-risk patients undergoing cardiac surgery with cardiopulmonary bypass.
Data source: The SIRS trial, a randomized, controlled international study that compared 30-day all-cause mortality and a composite endpoint in more than 7,500 high risk patients undergoing cardiac surgery with cardiopulmonary bypass randomized to receive an intravenous dose of methylprednisolone or placebo.
Disclosures: SIRS was funded with grants from the Canadian Institutes for Health Research and the Canadian Network and Centre for Trials Internationally. Dr. Whitlock said he had no relevant financial disclosures.
Survival after TAVR superior to surgery in high-risk aortic stenosis patients
WASHINGTON – A first in transcatheter aortic valve replacement trials, the CoreValve prosthesis was superior to surgical valve replacement in patients with severe aortic stenosis at increased surgical risk, showing a significantly lower risk of mortality 1 year later.
In the U.S. CoreValve High Risk Study, a prospective randomized controlled study of almost 800 patients, the rate of all-cause mortality at 1 year, the primary endpoint, was 14.2% among those in the transcatheter aortic valve replacement (TAVR) group, compared with 19.1% among those in the surgery group, a statistically significant difference that represented a 26% survival benefit at 1 year for the CoreValve, Dr. David H. Adams reported at the annual meeting of the American College of Cardiology.
his is the first prospective, randomized study to show superiority for transcatheter valve therapy over surgery, and "there’s no study or trial that I’m aware of that’s suggested that TAVR patients would have a superior survival outcome," Dr. Adams of Mount Sinai Medical Center, New York, said in an interview. Based on these results, he said he expects that TAVR "will increasingly become the alternative of choice for patients" at this level of risk.
The study was the high-risk arm of the U.S. CoreValve pivotal trial. The CoreValve self-expanding prosthesis was approved in January 2014 by the Food and Drug Administration for use in extreme risk patients, based on the results of the extreme risk cohort of patients.The data from the study in the high-risk trial are being reviewed at the FDA, according to the manufacturer, Medtronic.
The study compared the safety and effectiveness of TAVR with the CoreValve device to surgical valve replacement in 795 patients at 45 U.S. centers. The patients had severe aortic stenosis, had New York Heart Association class II heart failure or higher, and were judged to have at least a 15% risk of death within 30 days after surgery and less than a 50% risk of death or irreversible complications within 30 days after surgery. Their mean age was about age 83 years, almost half were females, most had class NYHA class III HF, and cardiac risk factors included coronary artery disease (in about two-thirds), previous coronary artery bypass surgery (about 30%), a previous MI (about 25%), and almost all had heart failure.
At 1 year, a composite of major adverse cardiovascular and cerebrovascular events (death from any cause, MI, any stroke, or reintervention), a secondary endpoint, was significantly lower among those on TAVR (20.4%) vs. the surgical group (27.3%). The rate of any stroke at 30 days was 4.9% in TAVR patients and 6.2% in the surgical group; and at 1 year, those rates were 8.8% and 12.6%, respectively; neither difference was statistically significant. Of the procedure-related outcomes, major vascular complications and permanent pacemaker implantations were significantly higher in the TAVR group (22.3% at 1 year, vs. 11.3% in the surgical group). In the TAVR group, there were five cases of cardiac perforation; there were no perforations in the surgical group.
Patients are being followed through 5 years. The 2-year mortality data are encouraging, with continued separation of the all-cause mortality curves, although the numbers are still small, Dr. Adams said at the meeting.
Among the study limitations was that more patients in the trial refused surgical valve replacement after randomization and the mortality rate within 30 days after surgery was 4.5%, which was lower than the rate specified for inclusion in the study, which was 15% or higher, so the patients may have been at a lower risk than planned, he said.
During the discussion, the inevitable comparisons to the results of the Placement of Aortic Transcatheter Valves A (PARTNER A) study were raised. In PARTNER A, which compared the safety and effectiveness of the balloon-expandable SAPIEN Transcatheter Heart Valve to aortic valve replacement surgery in high risk patients with severe symptomatic aortic stenosis, found no difference in mortality between the two arms and an increase in cerebrovascular events in the TAVR arm.
Dr. Adams said that different characteristics of the device in the two trials are possible explanations as to why the TAVR results were superior to surgery in the CoreValve study, and not in PARTNER A. "The size of the catheter as well as perhaps the self-expanding nature of the device both could help explain that," he said.
While patient risk was assessed differently in the studies, and the Society of Thoracic Surgeons scores of the patients were different, "we’re confident these were patients at increased risk for surgery," he added.
The study was published simultaneously in the New England Journal of Medicine on March 29 (2014 March 29 [doi:10.1056/NEJMoa1400590]).
The study is funded by the CoreValve manufacturer, Medtronic. Dr. Adams disclosed receiving grant support from Medtronic during the conduct of the study and other support from Medtronic and Edwards Lifesciences outside the submitted work.
WASHINGTON – A first in transcatheter aortic valve replacement trials, the CoreValve prosthesis was superior to surgical valve replacement in patients with severe aortic stenosis at increased surgical risk, showing a significantly lower risk of mortality 1 year later.
In the U.S. CoreValve High Risk Study, a prospective randomized controlled study of almost 800 patients, the rate of all-cause mortality at 1 year, the primary endpoint, was 14.2% among those in the transcatheter aortic valve replacement (TAVR) group, compared with 19.1% among those in the surgery group, a statistically significant difference that represented a 26% survival benefit at 1 year for the CoreValve, Dr. David H. Adams reported at the annual meeting of the American College of Cardiology.
his is the first prospective, randomized study to show superiority for transcatheter valve therapy over surgery, and "there’s no study or trial that I’m aware of that’s suggested that TAVR patients would have a superior survival outcome," Dr. Adams of Mount Sinai Medical Center, New York, said in an interview. Based on these results, he said he expects that TAVR "will increasingly become the alternative of choice for patients" at this level of risk.
The study was the high-risk arm of the U.S. CoreValve pivotal trial. The CoreValve self-expanding prosthesis was approved in January 2014 by the Food and Drug Administration for use in extreme risk patients, based on the results of the extreme risk cohort of patients.The data from the study in the high-risk trial are being reviewed at the FDA, according to the manufacturer, Medtronic.
The study compared the safety and effectiveness of TAVR with the CoreValve device to surgical valve replacement in 795 patients at 45 U.S. centers. The patients had severe aortic stenosis, had New York Heart Association class II heart failure or higher, and were judged to have at least a 15% risk of death within 30 days after surgery and less than a 50% risk of death or irreversible complications within 30 days after surgery. Their mean age was about age 83 years, almost half were females, most had class NYHA class III HF, and cardiac risk factors included coronary artery disease (in about two-thirds), previous coronary artery bypass surgery (about 30%), a previous MI (about 25%), and almost all had heart failure.
At 1 year, a composite of major adverse cardiovascular and cerebrovascular events (death from any cause, MI, any stroke, or reintervention), a secondary endpoint, was significantly lower among those on TAVR (20.4%) vs. the surgical group (27.3%). The rate of any stroke at 30 days was 4.9% in TAVR patients and 6.2% in the surgical group; and at 1 year, those rates were 8.8% and 12.6%, respectively; neither difference was statistically significant. Of the procedure-related outcomes, major vascular complications and permanent pacemaker implantations were significantly higher in the TAVR group (22.3% at 1 year, vs. 11.3% in the surgical group). In the TAVR group, there were five cases of cardiac perforation; there were no perforations in the surgical group.
Patients are being followed through 5 years. The 2-year mortality data are encouraging, with continued separation of the all-cause mortality curves, although the numbers are still small, Dr. Adams said at the meeting.
Among the study limitations was that more patients in the trial refused surgical valve replacement after randomization and the mortality rate within 30 days after surgery was 4.5%, which was lower than the rate specified for inclusion in the study, which was 15% or higher, so the patients may have been at a lower risk than planned, he said.
During the discussion, the inevitable comparisons to the results of the Placement of Aortic Transcatheter Valves A (PARTNER A) study were raised. In PARTNER A, which compared the safety and effectiveness of the balloon-expandable SAPIEN Transcatheter Heart Valve to aortic valve replacement surgery in high risk patients with severe symptomatic aortic stenosis, found no difference in mortality between the two arms and an increase in cerebrovascular events in the TAVR arm.
Dr. Adams said that different characteristics of the device in the two trials are possible explanations as to why the TAVR results were superior to surgery in the CoreValve study, and not in PARTNER A. "The size of the catheter as well as perhaps the self-expanding nature of the device both could help explain that," he said.
While patient risk was assessed differently in the studies, and the Society of Thoracic Surgeons scores of the patients were different, "we’re confident these were patients at increased risk for surgery," he added.
The study was published simultaneously in the New England Journal of Medicine on March 29 (2014 March 29 [doi:10.1056/NEJMoa1400590]).
The study is funded by the CoreValve manufacturer, Medtronic. Dr. Adams disclosed receiving grant support from Medtronic during the conduct of the study and other support from Medtronic and Edwards Lifesciences outside the submitted work.
WASHINGTON – A first in transcatheter aortic valve replacement trials, the CoreValve prosthesis was superior to surgical valve replacement in patients with severe aortic stenosis at increased surgical risk, showing a significantly lower risk of mortality 1 year later.
In the U.S. CoreValve High Risk Study, a prospective randomized controlled study of almost 800 patients, the rate of all-cause mortality at 1 year, the primary endpoint, was 14.2% among those in the transcatheter aortic valve replacement (TAVR) group, compared with 19.1% among those in the surgery group, a statistically significant difference that represented a 26% survival benefit at 1 year for the CoreValve, Dr. David H. Adams reported at the annual meeting of the American College of Cardiology.
his is the first prospective, randomized study to show superiority for transcatheter valve therapy over surgery, and "there’s no study or trial that I’m aware of that’s suggested that TAVR patients would have a superior survival outcome," Dr. Adams of Mount Sinai Medical Center, New York, said in an interview. Based on these results, he said he expects that TAVR "will increasingly become the alternative of choice for patients" at this level of risk.
The study was the high-risk arm of the U.S. CoreValve pivotal trial. The CoreValve self-expanding prosthesis was approved in January 2014 by the Food and Drug Administration for use in extreme risk patients, based on the results of the extreme risk cohort of patients.The data from the study in the high-risk trial are being reviewed at the FDA, according to the manufacturer, Medtronic.
The study compared the safety and effectiveness of TAVR with the CoreValve device to surgical valve replacement in 795 patients at 45 U.S. centers. The patients had severe aortic stenosis, had New York Heart Association class II heart failure or higher, and were judged to have at least a 15% risk of death within 30 days after surgery and less than a 50% risk of death or irreversible complications within 30 days after surgery. Their mean age was about age 83 years, almost half were females, most had class NYHA class III HF, and cardiac risk factors included coronary artery disease (in about two-thirds), previous coronary artery bypass surgery (about 30%), a previous MI (about 25%), and almost all had heart failure.
At 1 year, a composite of major adverse cardiovascular and cerebrovascular events (death from any cause, MI, any stroke, or reintervention), a secondary endpoint, was significantly lower among those on TAVR (20.4%) vs. the surgical group (27.3%). The rate of any stroke at 30 days was 4.9% in TAVR patients and 6.2% in the surgical group; and at 1 year, those rates were 8.8% and 12.6%, respectively; neither difference was statistically significant. Of the procedure-related outcomes, major vascular complications and permanent pacemaker implantations were significantly higher in the TAVR group (22.3% at 1 year, vs. 11.3% in the surgical group). In the TAVR group, there were five cases of cardiac perforation; there were no perforations in the surgical group.
Patients are being followed through 5 years. The 2-year mortality data are encouraging, with continued separation of the all-cause mortality curves, although the numbers are still small, Dr. Adams said at the meeting.
Among the study limitations was that more patients in the trial refused surgical valve replacement after randomization and the mortality rate within 30 days after surgery was 4.5%, which was lower than the rate specified for inclusion in the study, which was 15% or higher, so the patients may have been at a lower risk than planned, he said.
During the discussion, the inevitable comparisons to the results of the Placement of Aortic Transcatheter Valves A (PARTNER A) study were raised. In PARTNER A, which compared the safety and effectiveness of the balloon-expandable SAPIEN Transcatheter Heart Valve to aortic valve replacement surgery in high risk patients with severe symptomatic aortic stenosis, found no difference in mortality between the two arms and an increase in cerebrovascular events in the TAVR arm.
Dr. Adams said that different characteristics of the device in the two trials are possible explanations as to why the TAVR results were superior to surgery in the CoreValve study, and not in PARTNER A. "The size of the catheter as well as perhaps the self-expanding nature of the device both could help explain that," he said.
While patient risk was assessed differently in the studies, and the Society of Thoracic Surgeons scores of the patients were different, "we’re confident these were patients at increased risk for surgery," he added.
The study was published simultaneously in the New England Journal of Medicine on March 29 (2014 March 29 [doi:10.1056/NEJMoa1400590]).
The study is funded by the CoreValve manufacturer, Medtronic. Dr. Adams disclosed receiving grant support from Medtronic during the conduct of the study and other support from Medtronic and Edwards Lifesciences outside the submitted work.
FROM ACC14
Major finding: All-cause mortality was 14.2% among high-risk patients with severe aortic stenosis 1 year after TAVR with a self-expanding aortic valve bioprosthesis, vs. 19.1% among those who had surgical aortic valve replacement, a highly statistically significant difference.
Data source: The multicenter prospective U.S. study compared survival at 1 year in 795 patients at high risk for surgery who were randomized to TAVR with the CoreValve device or surgical aortic valve replacement.
Disclosures: The study is funded by the CoreValve manufacturer, Medtronic. Dr. Adams disclosed receiving grant support from Medtronic during the conduct of the study and other support from Medtronic and Edwards Lifesciences outside the study.
Controversies in dual antiplatelet therapy post PCI
SNOWMASS, COLO. – Wide local variation in the guideline-recommended use of low-dose aspirin as part of dual antiplatelet therapy after coronary stent implantation appears to be a prime target for a quality improvement effort.
American College of Cardiology/American Heart Association guidelines recommend aspirin at 81 mg/day along with an oral thienopyridine for maintenance therapy after percutaneous coronary intervention (PCI). This Class IIa/Level of Evidence B recommendation for preferential use of low- rather than high-dose aspirin is based upon the results of the OASIS 7 study (N. Engl. J. Med. 2010;354:1706-17) and other randomized trials that demonstrate that low- and high-dose aspirin (300-325 mg/day) are equally effective in reducing ischemic complications after PCI but that high-dose aspirin is associated with an increased risk of bleeding, Dr. Patrick T. O’Gara noted at the Annual Cardiovascular Conference at Snowmass.
Yet in a contemporary series of more than 23,000 U.S. patients enrolled in the major ongoing Dual Antiplatelet Therapy Study, only 28% were placed on low-dose aspirin at discharge after PCI; the rest got high-dose aspirin as part of their dual antiplatelet therapy (DAPT). In contrast, 90% of study participants from other countries got low-dose aspirin for their DAPT, commented Dr. O’Gara, who is ACC president-elect and professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, both in Boston.
The DAPT Study investigators determined that patient characteristics explained a mere 1.6% of the total variation in aspirin dosing. Site of enrollment accounted for 46% of the unexplained variation (Am. J. Cardiol. 201;113:1146-52).
The optimal duration of DAPT after PCI with placement of a drug-eluting stent remains unclear. Current guidelines call for at least 12 months of DAPT. The massive DAPT Study is designed to learn whether longer than 12 months is better. Participants were placed on 12 months of aspirin plus a thienopyridine, then randomized to an additional 18 months of DAPT or to aspirin plus placebo. The trial includes a variety of stents and indications for implantation. Results are expected later this year.
In the meantime, Dr. O’Gara said, the use of more than 12 months of DAPT is highly variable around the world. Studies suggest that at 3 years post-PCI, 40%-50% of North American patients remain on DAPT compared to about 10% of patients in Europe and elsewhere.
The ACC/AHA guidelines state as a relatively weak Class IIb/Level of Evidence C recommendation that continuation of DAPT beyond 12 months "may be considered" in drug-eluting stent recipients. Until the results of the DAPT Study become available to provide further guidance, however, Dr. O’Gara urged his colleagues to weigh this decision carefully on a case by case basis.
"The duration of DAPT is uncertain, but if you choose to continue therapy beyond 12 months, I think you need to be aware of the increasing number of trials that show no benefit of doing that – and an excess hazard of bleeding by doing so," he cautioned.
Dr. O’Gara cited three such major randomized trials totaling more than 6,100 patients: the Italian PRODIGY trial (Circulation 2012;125:2015-26), in which patients had near-identical rates of the 2-year composite of all-cause mortality, MI, or cerebrovascular accident regardless of whether they were randomized to 6 or 24 months of DAPT; the Korean combined REAL-LATE and ZEST-LATE trials (N. Engl. J. Med. 2010;362:1374-82), in which 12 and 24 months of DAPT resulted in similar rates of MI or cardiac death at 2 years; and EXCELLENT, in which 12 months of DAPT proved no better than 6 in terms of the combined endpoint of cardiac death, MI, or target vessel revascularization (Circulation 2012;125:505-13).
Moreover, a secondary analysis of the Korean trials found a 2.96-fold increased risk of Thrombosis in Myocardial Infarction major bleeding in patients on DAPT for longer than 12 months. And PRODIGY investigators found a 2.7-fold increased major bleeding risk with 24 as compared to 6 months of DAPT.
Further uncertainty regarding the optimal duration of DAPT comes from the OPTIMIZE trial, in which 3,119 Brazilian patients with low-risk acute coronary syndrome or stable coronary artery disease received a zotarolimus-eluting stent and were randomized to 3 or 12 months of DAPT. There was no difference between the two groups in the combined endpoint of all-cause mortality, MI, stroke, or major bleeding (JAMA 2013;310:2510-22).
"Interestingly enough, in Europe the zotarolimus-eluting stent has achieved approval for a 3-month course of dual antiplatelet therapy," Dr. O’Gara said.
He reported having no financial conflicts.
SNOWMASS, COLO. – Wide local variation in the guideline-recommended use of low-dose aspirin as part of dual antiplatelet therapy after coronary stent implantation appears to be a prime target for a quality improvement effort.
American College of Cardiology/American Heart Association guidelines recommend aspirin at 81 mg/day along with an oral thienopyridine for maintenance therapy after percutaneous coronary intervention (PCI). This Class IIa/Level of Evidence B recommendation for preferential use of low- rather than high-dose aspirin is based upon the results of the OASIS 7 study (N. Engl. J. Med. 2010;354:1706-17) and other randomized trials that demonstrate that low- and high-dose aspirin (300-325 mg/day) are equally effective in reducing ischemic complications after PCI but that high-dose aspirin is associated with an increased risk of bleeding, Dr. Patrick T. O’Gara noted at the Annual Cardiovascular Conference at Snowmass.
Yet in a contemporary series of more than 23,000 U.S. patients enrolled in the major ongoing Dual Antiplatelet Therapy Study, only 28% were placed on low-dose aspirin at discharge after PCI; the rest got high-dose aspirin as part of their dual antiplatelet therapy (DAPT). In contrast, 90% of study participants from other countries got low-dose aspirin for their DAPT, commented Dr. O’Gara, who is ACC president-elect and professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, both in Boston.
The DAPT Study investigators determined that patient characteristics explained a mere 1.6% of the total variation in aspirin dosing. Site of enrollment accounted for 46% of the unexplained variation (Am. J. Cardiol. 201;113:1146-52).
The optimal duration of DAPT after PCI with placement of a drug-eluting stent remains unclear. Current guidelines call for at least 12 months of DAPT. The massive DAPT Study is designed to learn whether longer than 12 months is better. Participants were placed on 12 months of aspirin plus a thienopyridine, then randomized to an additional 18 months of DAPT or to aspirin plus placebo. The trial includes a variety of stents and indications for implantation. Results are expected later this year.
In the meantime, Dr. O’Gara said, the use of more than 12 months of DAPT is highly variable around the world. Studies suggest that at 3 years post-PCI, 40%-50% of North American patients remain on DAPT compared to about 10% of patients in Europe and elsewhere.
The ACC/AHA guidelines state as a relatively weak Class IIb/Level of Evidence C recommendation that continuation of DAPT beyond 12 months "may be considered" in drug-eluting stent recipients. Until the results of the DAPT Study become available to provide further guidance, however, Dr. O’Gara urged his colleagues to weigh this decision carefully on a case by case basis.
"The duration of DAPT is uncertain, but if you choose to continue therapy beyond 12 months, I think you need to be aware of the increasing number of trials that show no benefit of doing that – and an excess hazard of bleeding by doing so," he cautioned.
Dr. O’Gara cited three such major randomized trials totaling more than 6,100 patients: the Italian PRODIGY trial (Circulation 2012;125:2015-26), in which patients had near-identical rates of the 2-year composite of all-cause mortality, MI, or cerebrovascular accident regardless of whether they were randomized to 6 or 24 months of DAPT; the Korean combined REAL-LATE and ZEST-LATE trials (N. Engl. J. Med. 2010;362:1374-82), in which 12 and 24 months of DAPT resulted in similar rates of MI or cardiac death at 2 years; and EXCELLENT, in which 12 months of DAPT proved no better than 6 in terms of the combined endpoint of cardiac death, MI, or target vessel revascularization (Circulation 2012;125:505-13).
Moreover, a secondary analysis of the Korean trials found a 2.96-fold increased risk of Thrombosis in Myocardial Infarction major bleeding in patients on DAPT for longer than 12 months. And PRODIGY investigators found a 2.7-fold increased major bleeding risk with 24 as compared to 6 months of DAPT.
Further uncertainty regarding the optimal duration of DAPT comes from the OPTIMIZE trial, in which 3,119 Brazilian patients with low-risk acute coronary syndrome or stable coronary artery disease received a zotarolimus-eluting stent and were randomized to 3 or 12 months of DAPT. There was no difference between the two groups in the combined endpoint of all-cause mortality, MI, stroke, or major bleeding (JAMA 2013;310:2510-22).
"Interestingly enough, in Europe the zotarolimus-eluting stent has achieved approval for a 3-month course of dual antiplatelet therapy," Dr. O’Gara said.
He reported having no financial conflicts.
SNOWMASS, COLO. – Wide local variation in the guideline-recommended use of low-dose aspirin as part of dual antiplatelet therapy after coronary stent implantation appears to be a prime target for a quality improvement effort.
American College of Cardiology/American Heart Association guidelines recommend aspirin at 81 mg/day along with an oral thienopyridine for maintenance therapy after percutaneous coronary intervention (PCI). This Class IIa/Level of Evidence B recommendation for preferential use of low- rather than high-dose aspirin is based upon the results of the OASIS 7 study (N. Engl. J. Med. 2010;354:1706-17) and other randomized trials that demonstrate that low- and high-dose aspirin (300-325 mg/day) are equally effective in reducing ischemic complications after PCI but that high-dose aspirin is associated with an increased risk of bleeding, Dr. Patrick T. O’Gara noted at the Annual Cardiovascular Conference at Snowmass.
Yet in a contemporary series of more than 23,000 U.S. patients enrolled in the major ongoing Dual Antiplatelet Therapy Study, only 28% were placed on low-dose aspirin at discharge after PCI; the rest got high-dose aspirin as part of their dual antiplatelet therapy (DAPT). In contrast, 90% of study participants from other countries got low-dose aspirin for their DAPT, commented Dr. O’Gara, who is ACC president-elect and professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, both in Boston.
The DAPT Study investigators determined that patient characteristics explained a mere 1.6% of the total variation in aspirin dosing. Site of enrollment accounted for 46% of the unexplained variation (Am. J. Cardiol. 201;113:1146-52).
The optimal duration of DAPT after PCI with placement of a drug-eluting stent remains unclear. Current guidelines call for at least 12 months of DAPT. The massive DAPT Study is designed to learn whether longer than 12 months is better. Participants were placed on 12 months of aspirin plus a thienopyridine, then randomized to an additional 18 months of DAPT or to aspirin plus placebo. The trial includes a variety of stents and indications for implantation. Results are expected later this year.
In the meantime, Dr. O’Gara said, the use of more than 12 months of DAPT is highly variable around the world. Studies suggest that at 3 years post-PCI, 40%-50% of North American patients remain on DAPT compared to about 10% of patients in Europe and elsewhere.
The ACC/AHA guidelines state as a relatively weak Class IIb/Level of Evidence C recommendation that continuation of DAPT beyond 12 months "may be considered" in drug-eluting stent recipients. Until the results of the DAPT Study become available to provide further guidance, however, Dr. O’Gara urged his colleagues to weigh this decision carefully on a case by case basis.
"The duration of DAPT is uncertain, but if you choose to continue therapy beyond 12 months, I think you need to be aware of the increasing number of trials that show no benefit of doing that – and an excess hazard of bleeding by doing so," he cautioned.
Dr. O’Gara cited three such major randomized trials totaling more than 6,100 patients: the Italian PRODIGY trial (Circulation 2012;125:2015-26), in which patients had near-identical rates of the 2-year composite of all-cause mortality, MI, or cerebrovascular accident regardless of whether they were randomized to 6 or 24 months of DAPT; the Korean combined REAL-LATE and ZEST-LATE trials (N. Engl. J. Med. 2010;362:1374-82), in which 12 and 24 months of DAPT resulted in similar rates of MI or cardiac death at 2 years; and EXCELLENT, in which 12 months of DAPT proved no better than 6 in terms of the combined endpoint of cardiac death, MI, or target vessel revascularization (Circulation 2012;125:505-13).
Moreover, a secondary analysis of the Korean trials found a 2.96-fold increased risk of Thrombosis in Myocardial Infarction major bleeding in patients on DAPT for longer than 12 months. And PRODIGY investigators found a 2.7-fold increased major bleeding risk with 24 as compared to 6 months of DAPT.
Further uncertainty regarding the optimal duration of DAPT comes from the OPTIMIZE trial, in which 3,119 Brazilian patients with low-risk acute coronary syndrome or stable coronary artery disease received a zotarolimus-eluting stent and were randomized to 3 or 12 months of DAPT. There was no difference between the two groups in the combined endpoint of all-cause mortality, MI, stroke, or major bleeding (JAMA 2013;310:2510-22).
"Interestingly enough, in Europe the zotarolimus-eluting stent has achieved approval for a 3-month course of dual antiplatelet therapy," Dr. O’Gara said.
He reported having no financial conflicts.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Wait! Put elective surgery on hold after stent placement
SCOTTSDALE, ARIZ. – The presence of a coronary artery stent is not a barrier to noncardiac surgery, but it may change the timing of surgery and perioperative management of the patient, a hospitalist cautions.
Patients who receive bare-metal stents should delay having elective surgery for at least 6 weeks after stent placement, and those who receive a drug-eluting stent should put off elective procedures for at least a year, said Dr. Amir K. Jaffer, professor of medicine and chief of the division of hospital medicine at Rush University Medical Center in Chicago.
The type of stent, its placement, and the time since placement are just some of the key pieces of information that clinicians need to manage patients, Dr. Jaffer said at a meeting on perioperative medicine sponsored by the University of Miami.
"You want to try to get that [information] card if you can from the patient, about where the stents were placed, and if they don’t have the card handy, you really need to go to the procedure note, because the patient may or may not know if it was a drug-eluting stent," he said.
Other vital pieces of the perioperative puzzle are which coronary vessel the stent was implanted in; when the stent was implanted; what drug, if any (sirolimus or paclitaxel) is eluted by the stent; whether there were surgical or postoperative complications; prior history of stent thrombosis; the patient’s comorbidities; duration of dual-antiplatelet therapy; and how the patient has fared on therapy.
Prior to an elective noncardiac procedure, clinicians must consider patient risk factors, including indication for antithrombotic therapy, risk factors for thrombosis or thromboembolism, and type of antithrombotic agent; and surgical risk factors, including type of procedure, bleeding risk, thromboembolism risk, and time off antithrombotic therapy.
When to stop antithrombotic agents
Dr. Jaffer noted that because aspirin is an irreversible inhibitor of platelet cyclooxygenase and the circulating platelet pool is replaced every 7 to 10 days, patients on aspirin as part of their dual-antiplatelet therapy should stop taking the drug from 7 to 10 days before scheduled surgery.
Thienopyridines/P2Y12 receptor antagonists such as clopidogrel (Plavix) and ticagrelor (Brilinta) work by inhibiting adenosine diphosphate (ADP) receptor-mediated platelet activation and aggregation. Dr. Jaffer said that although guidelines recommend stopping these agents 7 days before surgery, there is evidence to suggest that 5 days may be a sufficient window of safety.
It is also important to take into consideration the pharmacokinetic profiles of the specific antiplatelet agents. For example, ticagrelor has a more rapid onset and greater degree of platelet-aggregation inhibition than clopidogrel, although the time from stopping each agent until the return to near-baseline platelet aggregation is similar, on the order of about 120 hours (5 days) or longer, he said.
Risk varies by surgery type
The type of surgery is also important, as certain procedures – such as neurocranial surgery, spinal canal surgery, and procedures performed in the posterior chamber of the eye – carry a high risk for hemorrhage and are likely to require blood transfusions.
Dr. Jaffer noted that in 2007, the American College of Cardiology and American Heart Association issued a joint advisory on antiplatelet therapy and noncardiac surgery, which warned health care providers about the potentially catastrophic risks of stopping thienopyridines prematurely, which could result in acute stent thrombosis, myocardial infarction, and death. The guidelines recommend waiting a minimum of 6 weeks for noncardiac surgery following implantation of a bare-metal stent, and 1 year after a drug-eluting stent.
He pointed to two studies from the Mayo Clinic published in 2008. The first study showed that the risk of major cardiac adverse events among patients with a bare-metal stent undergoing noncardiac surgery within 30 days of stent placement was approximately 10%, but diminished to 2.7% at 91 days after placement (Anesthesiology 2008;109:588-95). The second study showed that the risk of major cardiac adverse events was 6.1% within 90 days after implantation of a drug-eluting stent, with the risk dwindling to 3.1% after 1 year (Anesthesiology 2008;109:596-604).
If urgent surgery such as a hemicolectomy for colon cancer is required within 6 months of drug-eluting stent implantation, the patient should continue on dual-antiplatelet therapy, Dr. Jaffer said. If the surgery is from 6 months to 1 year after implantation in these patients, the patient should be continued on at least 81 mg aspirin, but if the patient is taking clopidogrel, he or she should have the thienopyridine discontinued 5 days before surgery and the drug resumed as soon as possible after surgery with a 300-mg loading dose, followed by 75 mg daily. If the patient is not yet able to eat, the dual-antiplatelet therapy should be delivered via nasogastric tube, he said.
Dr. Jaffer reported serving as a consultant to Boehringer Ingelheim, Janssen Pharmaceuticals, and other companies. Dr. Jaffer also serves on the editorial advisory board of Hospitalist News.
SCOTTSDALE, ARIZ. – The presence of a coronary artery stent is not a barrier to noncardiac surgery, but it may change the timing of surgery and perioperative management of the patient, a hospitalist cautions.
Patients who receive bare-metal stents should delay having elective surgery for at least 6 weeks after stent placement, and those who receive a drug-eluting stent should put off elective procedures for at least a year, said Dr. Amir K. Jaffer, professor of medicine and chief of the division of hospital medicine at Rush University Medical Center in Chicago.
The type of stent, its placement, and the time since placement are just some of the key pieces of information that clinicians need to manage patients, Dr. Jaffer said at a meeting on perioperative medicine sponsored by the University of Miami.
"You want to try to get that [information] card if you can from the patient, about where the stents were placed, and if they don’t have the card handy, you really need to go to the procedure note, because the patient may or may not know if it was a drug-eluting stent," he said.
Other vital pieces of the perioperative puzzle are which coronary vessel the stent was implanted in; when the stent was implanted; what drug, if any (sirolimus or paclitaxel) is eluted by the stent; whether there were surgical or postoperative complications; prior history of stent thrombosis; the patient’s comorbidities; duration of dual-antiplatelet therapy; and how the patient has fared on therapy.
Prior to an elective noncardiac procedure, clinicians must consider patient risk factors, including indication for antithrombotic therapy, risk factors for thrombosis or thromboembolism, and type of antithrombotic agent; and surgical risk factors, including type of procedure, bleeding risk, thromboembolism risk, and time off antithrombotic therapy.
When to stop antithrombotic agents
Dr. Jaffer noted that because aspirin is an irreversible inhibitor of platelet cyclooxygenase and the circulating platelet pool is replaced every 7 to 10 days, patients on aspirin as part of their dual-antiplatelet therapy should stop taking the drug from 7 to 10 days before scheduled surgery.
Thienopyridines/P2Y12 receptor antagonists such as clopidogrel (Plavix) and ticagrelor (Brilinta) work by inhibiting adenosine diphosphate (ADP) receptor-mediated platelet activation and aggregation. Dr. Jaffer said that although guidelines recommend stopping these agents 7 days before surgery, there is evidence to suggest that 5 days may be a sufficient window of safety.
It is also important to take into consideration the pharmacokinetic profiles of the specific antiplatelet agents. For example, ticagrelor has a more rapid onset and greater degree of platelet-aggregation inhibition than clopidogrel, although the time from stopping each agent until the return to near-baseline platelet aggregation is similar, on the order of about 120 hours (5 days) or longer, he said.
Risk varies by surgery type
The type of surgery is also important, as certain procedures – such as neurocranial surgery, spinal canal surgery, and procedures performed in the posterior chamber of the eye – carry a high risk for hemorrhage and are likely to require blood transfusions.
Dr. Jaffer noted that in 2007, the American College of Cardiology and American Heart Association issued a joint advisory on antiplatelet therapy and noncardiac surgery, which warned health care providers about the potentially catastrophic risks of stopping thienopyridines prematurely, which could result in acute stent thrombosis, myocardial infarction, and death. The guidelines recommend waiting a minimum of 6 weeks for noncardiac surgery following implantation of a bare-metal stent, and 1 year after a drug-eluting stent.
He pointed to two studies from the Mayo Clinic published in 2008. The first study showed that the risk of major cardiac adverse events among patients with a bare-metal stent undergoing noncardiac surgery within 30 days of stent placement was approximately 10%, but diminished to 2.7% at 91 days after placement (Anesthesiology 2008;109:588-95). The second study showed that the risk of major cardiac adverse events was 6.1% within 90 days after implantation of a drug-eluting stent, with the risk dwindling to 3.1% after 1 year (Anesthesiology 2008;109:596-604).
If urgent surgery such as a hemicolectomy for colon cancer is required within 6 months of drug-eluting stent implantation, the patient should continue on dual-antiplatelet therapy, Dr. Jaffer said. If the surgery is from 6 months to 1 year after implantation in these patients, the patient should be continued on at least 81 mg aspirin, but if the patient is taking clopidogrel, he or she should have the thienopyridine discontinued 5 days before surgery and the drug resumed as soon as possible after surgery with a 300-mg loading dose, followed by 75 mg daily. If the patient is not yet able to eat, the dual-antiplatelet therapy should be delivered via nasogastric tube, he said.
Dr. Jaffer reported serving as a consultant to Boehringer Ingelheim, Janssen Pharmaceuticals, and other companies. Dr. Jaffer also serves on the editorial advisory board of Hospitalist News.
SCOTTSDALE, ARIZ. – The presence of a coronary artery stent is not a barrier to noncardiac surgery, but it may change the timing of surgery and perioperative management of the patient, a hospitalist cautions.
Patients who receive bare-metal stents should delay having elective surgery for at least 6 weeks after stent placement, and those who receive a drug-eluting stent should put off elective procedures for at least a year, said Dr. Amir K. Jaffer, professor of medicine and chief of the division of hospital medicine at Rush University Medical Center in Chicago.
The type of stent, its placement, and the time since placement are just some of the key pieces of information that clinicians need to manage patients, Dr. Jaffer said at a meeting on perioperative medicine sponsored by the University of Miami.
"You want to try to get that [information] card if you can from the patient, about where the stents were placed, and if they don’t have the card handy, you really need to go to the procedure note, because the patient may or may not know if it was a drug-eluting stent," he said.
Other vital pieces of the perioperative puzzle are which coronary vessel the stent was implanted in; when the stent was implanted; what drug, if any (sirolimus or paclitaxel) is eluted by the stent; whether there were surgical or postoperative complications; prior history of stent thrombosis; the patient’s comorbidities; duration of dual-antiplatelet therapy; and how the patient has fared on therapy.
Prior to an elective noncardiac procedure, clinicians must consider patient risk factors, including indication for antithrombotic therapy, risk factors for thrombosis or thromboembolism, and type of antithrombotic agent; and surgical risk factors, including type of procedure, bleeding risk, thromboembolism risk, and time off antithrombotic therapy.
When to stop antithrombotic agents
Dr. Jaffer noted that because aspirin is an irreversible inhibitor of platelet cyclooxygenase and the circulating platelet pool is replaced every 7 to 10 days, patients on aspirin as part of their dual-antiplatelet therapy should stop taking the drug from 7 to 10 days before scheduled surgery.
Thienopyridines/P2Y12 receptor antagonists such as clopidogrel (Plavix) and ticagrelor (Brilinta) work by inhibiting adenosine diphosphate (ADP) receptor-mediated platelet activation and aggregation. Dr. Jaffer said that although guidelines recommend stopping these agents 7 days before surgery, there is evidence to suggest that 5 days may be a sufficient window of safety.
It is also important to take into consideration the pharmacokinetic profiles of the specific antiplatelet agents. For example, ticagrelor has a more rapid onset and greater degree of platelet-aggregation inhibition than clopidogrel, although the time from stopping each agent until the return to near-baseline platelet aggregation is similar, on the order of about 120 hours (5 days) or longer, he said.
Risk varies by surgery type
The type of surgery is also important, as certain procedures – such as neurocranial surgery, spinal canal surgery, and procedures performed in the posterior chamber of the eye – carry a high risk for hemorrhage and are likely to require blood transfusions.
Dr. Jaffer noted that in 2007, the American College of Cardiology and American Heart Association issued a joint advisory on antiplatelet therapy and noncardiac surgery, which warned health care providers about the potentially catastrophic risks of stopping thienopyridines prematurely, which could result in acute stent thrombosis, myocardial infarction, and death. The guidelines recommend waiting a minimum of 6 weeks for noncardiac surgery following implantation of a bare-metal stent, and 1 year after a drug-eluting stent.
He pointed to two studies from the Mayo Clinic published in 2008. The first study showed that the risk of major cardiac adverse events among patients with a bare-metal stent undergoing noncardiac surgery within 30 days of stent placement was approximately 10%, but diminished to 2.7% at 91 days after placement (Anesthesiology 2008;109:588-95). The second study showed that the risk of major cardiac adverse events was 6.1% within 90 days after implantation of a drug-eluting stent, with the risk dwindling to 3.1% after 1 year (Anesthesiology 2008;109:596-604).
If urgent surgery such as a hemicolectomy for colon cancer is required within 6 months of drug-eluting stent implantation, the patient should continue on dual-antiplatelet therapy, Dr. Jaffer said. If the surgery is from 6 months to 1 year after implantation in these patients, the patient should be continued on at least 81 mg aspirin, but if the patient is taking clopidogrel, he or she should have the thienopyridine discontinued 5 days before surgery and the drug resumed as soon as possible after surgery with a 300-mg loading dose, followed by 75 mg daily. If the patient is not yet able to eat, the dual-antiplatelet therapy should be delivered via nasogastric tube, he said.
Dr. Jaffer reported serving as a consultant to Boehringer Ingelheim, Janssen Pharmaceuticals, and other companies. Dr. Jaffer also serves on the editorial advisory board of Hospitalist News.
EXPERT ANALYSIS FROM THE PERIOPERATIVE MEDICINE SUMMIT
Major finding: Elective noncardiac surgery should be delayed for at least 6 weeks following implantation of a bare-metal stent, and 1 year after implantation of a drug-eluting stent.
Data source: Evidence-based review of data on the risk of adverse events following noncardiac surgery in patients with coronary artery stents.
Disclosures: Dr. Jaffer reported serving as a consultant to Boehringer Ingelheim, Janssen Pharmaceuticals, and other companies. Dr. Jaffer also serves on the editorial advisory board of Hospitalist News.
Strong nerves, teamwork key in managing neurosurgical patients, devices
SCOTTSDALE, ARIZ. – Comanaging neurosurgical patients requires a delicate dance between primary practitioners, surgeons, anesthesiologists, and, in some cases, the makers of implantable neurostimulators, according to perioperative medicine specialists.
Special considerations with patients scheduled for neurosurgical procedures include hypertension, fever, hyponatremia, and risk of deep vein thromboembolism (DVT) and coagulopathies, said Dr. Richard Huh, director of the inpatient medical consultation service at Rush University Medical Center in Chicago, at a meeting on perioperative medicine sponsored by the University of Miami.
For example, hospitalists are typically involved in the management of blood pressure in neurosurgery patients because of the importance of controlling intracranial pressure, Dr. Huh noted.
"The trick is for the blood pressure not to get too high or too low. The Handbook of Neurosurgery suggests a goal of 140 over 90 [mm Hg]," he said.
Patients with acute subarachnoid hemorrhage are at risk for vasospasm, most frequently within 7-10 days of hemorrhage. Hypovolemia is a common cause of vasospasm and should be avoided. Medications such as nimodipine (Nimotop) can help prevent this complication.
Patients undergoing spinal procedures tend to have low blood pressure from acute blood loss or intravenous pain medications, and may require hold parameters on medications to avoid complications from hypotension.
However, on the day following spinal surgery, some patients develop hypertension, and may require additional medications for BP control.
Hyponatremia
The reported prevalence of hyponatremia in hospitalized patients ranges from 1%-7%, and the rate is even higher in neurosurgical patients, possibility because the brain’s response to changes in osmolality. Clinicians managing neurosurgical patients should be aware of the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and cerebral salt wasting, Dr. Huh said.
Cerebral salt wasting may be cause by damaged brain cells that affect sympathetic neural input to the kidneys, decreasing sodium resorption and an increase in atrial natriuretic peptide and brain natriuretic peptide.
The syndrome looks similar to SIADH, with high urinary sodium and osmolality, low serum osmolality, and decreased serum uric acid. But cerebral salt wasting is distinguished from SIADH by the presence of hypovolemia. Cerebral salt wasting is treated with saline and/or salt tablets.
DVT
Neurosurgical patients are at increased risk for DVT and pulmonary embolism compared with the general postoperative population. However, 2012 guidelines on antithrombotic therapy from the American College of Chest Physicians recommend against pharmacologic prophylaxis except for high risk patients, such as patients with intracranial masses. Dr. Huh said.
Implantable neurostimulators
Patients with implanted devices such as deep-brain stimulators for control of Parkinson’s disease, hypoglossal nerve stimulators for severe sleep apnea, or vagal nerve stimulators for epilepsy also require special consideration throughout the perioperative period.
Issues to consider when managing a patient with an implantable device include the device site and its proximity to the planned surgical field, indication for the device, comorbidities, and the patient’s goals for treatment, said Dr. Deborah Richman, section chief of preoperative services at Stony Brook (New York) University Medical Center.
"What do we do with device itself? This is a team approach, and we find that it’s best coordinated by our nurses in the preop holding area, because they know what time the surgery is, they have the device company rep’s phone number, they make sure the patient is there on time, and they put everything together to prevent delays on the day of surgery," she said.
In general, device manufacturers recommend turning devices off, and to turn the amplitude down to zero to prevent accidental activation of magnetic on-off switches.
The distance from the surgery to the pulse generator should be a minimum of 20 cm, and electrocautery, if used, should be bipolar rather than monopolar, Dr. Richman said.
Patients with implanted devices will also require prophylactic antibiotics to prevent potential bacterial seeding of the device or leads, she said,
Coordination of perioperative care "is best done with clinical management pathways, so that when you have one of these patients who present to you, you have a checklist that includes the device company’s phone number, and it’s an easy go-to, so that you don’t have to start from scratch each time," she concluded.
Dr. Huh and Dr. Richman reported having no financial disclosures.
SCOTTSDALE, ARIZ. – Comanaging neurosurgical patients requires a delicate dance between primary practitioners, surgeons, anesthesiologists, and, in some cases, the makers of implantable neurostimulators, according to perioperative medicine specialists.
Special considerations with patients scheduled for neurosurgical procedures include hypertension, fever, hyponatremia, and risk of deep vein thromboembolism (DVT) and coagulopathies, said Dr. Richard Huh, director of the inpatient medical consultation service at Rush University Medical Center in Chicago, at a meeting on perioperative medicine sponsored by the University of Miami.
For example, hospitalists are typically involved in the management of blood pressure in neurosurgery patients because of the importance of controlling intracranial pressure, Dr. Huh noted.
"The trick is for the blood pressure not to get too high or too low. The Handbook of Neurosurgery suggests a goal of 140 over 90 [mm Hg]," he said.
Patients with acute subarachnoid hemorrhage are at risk for vasospasm, most frequently within 7-10 days of hemorrhage. Hypovolemia is a common cause of vasospasm and should be avoided. Medications such as nimodipine (Nimotop) can help prevent this complication.
Patients undergoing spinal procedures tend to have low blood pressure from acute blood loss or intravenous pain medications, and may require hold parameters on medications to avoid complications from hypotension.
However, on the day following spinal surgery, some patients develop hypertension, and may require additional medications for BP control.
Hyponatremia
The reported prevalence of hyponatremia in hospitalized patients ranges from 1%-7%, and the rate is even higher in neurosurgical patients, possibility because the brain’s response to changes in osmolality. Clinicians managing neurosurgical patients should be aware of the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and cerebral salt wasting, Dr. Huh said.
Cerebral salt wasting may be cause by damaged brain cells that affect sympathetic neural input to the kidneys, decreasing sodium resorption and an increase in atrial natriuretic peptide and brain natriuretic peptide.
The syndrome looks similar to SIADH, with high urinary sodium and osmolality, low serum osmolality, and decreased serum uric acid. But cerebral salt wasting is distinguished from SIADH by the presence of hypovolemia. Cerebral salt wasting is treated with saline and/or salt tablets.
DVT
Neurosurgical patients are at increased risk for DVT and pulmonary embolism compared with the general postoperative population. However, 2012 guidelines on antithrombotic therapy from the American College of Chest Physicians recommend against pharmacologic prophylaxis except for high risk patients, such as patients with intracranial masses. Dr. Huh said.
Implantable neurostimulators
Patients with implanted devices such as deep-brain stimulators for control of Parkinson’s disease, hypoglossal nerve stimulators for severe sleep apnea, or vagal nerve stimulators for epilepsy also require special consideration throughout the perioperative period.
Issues to consider when managing a patient with an implantable device include the device site and its proximity to the planned surgical field, indication for the device, comorbidities, and the patient’s goals for treatment, said Dr. Deborah Richman, section chief of preoperative services at Stony Brook (New York) University Medical Center.
"What do we do with device itself? This is a team approach, and we find that it’s best coordinated by our nurses in the preop holding area, because they know what time the surgery is, they have the device company rep’s phone number, they make sure the patient is there on time, and they put everything together to prevent delays on the day of surgery," she said.
In general, device manufacturers recommend turning devices off, and to turn the amplitude down to zero to prevent accidental activation of magnetic on-off switches.
The distance from the surgery to the pulse generator should be a minimum of 20 cm, and electrocautery, if used, should be bipolar rather than monopolar, Dr. Richman said.
Patients with implanted devices will also require prophylactic antibiotics to prevent potential bacterial seeding of the device or leads, she said,
Coordination of perioperative care "is best done with clinical management pathways, so that when you have one of these patients who present to you, you have a checklist that includes the device company’s phone number, and it’s an easy go-to, so that you don’t have to start from scratch each time," she concluded.
Dr. Huh and Dr. Richman reported having no financial disclosures.
SCOTTSDALE, ARIZ. – Comanaging neurosurgical patients requires a delicate dance between primary practitioners, surgeons, anesthesiologists, and, in some cases, the makers of implantable neurostimulators, according to perioperative medicine specialists.
Special considerations with patients scheduled for neurosurgical procedures include hypertension, fever, hyponatremia, and risk of deep vein thromboembolism (DVT) and coagulopathies, said Dr. Richard Huh, director of the inpatient medical consultation service at Rush University Medical Center in Chicago, at a meeting on perioperative medicine sponsored by the University of Miami.
For example, hospitalists are typically involved in the management of blood pressure in neurosurgery patients because of the importance of controlling intracranial pressure, Dr. Huh noted.
"The trick is for the blood pressure not to get too high or too low. The Handbook of Neurosurgery suggests a goal of 140 over 90 [mm Hg]," he said.
Patients with acute subarachnoid hemorrhage are at risk for vasospasm, most frequently within 7-10 days of hemorrhage. Hypovolemia is a common cause of vasospasm and should be avoided. Medications such as nimodipine (Nimotop) can help prevent this complication.
Patients undergoing spinal procedures tend to have low blood pressure from acute blood loss or intravenous pain medications, and may require hold parameters on medications to avoid complications from hypotension.
However, on the day following spinal surgery, some patients develop hypertension, and may require additional medications for BP control.
Hyponatremia
The reported prevalence of hyponatremia in hospitalized patients ranges from 1%-7%, and the rate is even higher in neurosurgical patients, possibility because the brain’s response to changes in osmolality. Clinicians managing neurosurgical patients should be aware of the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and cerebral salt wasting, Dr. Huh said.
Cerebral salt wasting may be cause by damaged brain cells that affect sympathetic neural input to the kidneys, decreasing sodium resorption and an increase in atrial natriuretic peptide and brain natriuretic peptide.
The syndrome looks similar to SIADH, with high urinary sodium and osmolality, low serum osmolality, and decreased serum uric acid. But cerebral salt wasting is distinguished from SIADH by the presence of hypovolemia. Cerebral salt wasting is treated with saline and/or salt tablets.
DVT
Neurosurgical patients are at increased risk for DVT and pulmonary embolism compared with the general postoperative population. However, 2012 guidelines on antithrombotic therapy from the American College of Chest Physicians recommend against pharmacologic prophylaxis except for high risk patients, such as patients with intracranial masses. Dr. Huh said.
Implantable neurostimulators
Patients with implanted devices such as deep-brain stimulators for control of Parkinson’s disease, hypoglossal nerve stimulators for severe sleep apnea, or vagal nerve stimulators for epilepsy also require special consideration throughout the perioperative period.
Issues to consider when managing a patient with an implantable device include the device site and its proximity to the planned surgical field, indication for the device, comorbidities, and the patient’s goals for treatment, said Dr. Deborah Richman, section chief of preoperative services at Stony Brook (New York) University Medical Center.
"What do we do with device itself? This is a team approach, and we find that it’s best coordinated by our nurses in the preop holding area, because they know what time the surgery is, they have the device company rep’s phone number, they make sure the patient is there on time, and they put everything together to prevent delays on the day of surgery," she said.
In general, device manufacturers recommend turning devices off, and to turn the amplitude down to zero to prevent accidental activation of magnetic on-off switches.
The distance from the surgery to the pulse generator should be a minimum of 20 cm, and electrocautery, if used, should be bipolar rather than monopolar, Dr. Richman said.
Patients with implanted devices will also require prophylactic antibiotics to prevent potential bacterial seeding of the device or leads, she said,
Coordination of perioperative care "is best done with clinical management pathways, so that when you have one of these patients who present to you, you have a checklist that includes the device company’s phone number, and it’s an easy go-to, so that you don’t have to start from scratch each time," she concluded.
Dr. Huh and Dr. Richman reported having no financial disclosures.
AT THE PERIOPERATIVE MEDICINE SUMMIT
Major finding: Neurosurgical procedures are associated with increased risk for complications, such as hyponatremia and deep vein thromboembolism, compared with general surgeries.
Data source: Reviews of recommendations on the perioperative management of neurosurgical patients and those with implanted neurostimulating devices.
Disclosures: Dr. Huh and Dr. Richman reported having no financial disclosures.
Calculate an STS score before all aortic valve replacements
SNOWMASS, COLO. – The Society of Thoracic Surgeons Predicted Risk of Mortality score draws criticism when it’s used to help decide whether a patient should undergo surgical or transcatheter aortic valve replacement, because the algorithm excludes plenty of information pertinent to that task. Yet for now it’s an indispensible tool for cardiologists and surgeons alike, Dr. Vinod H. Thourani asserted at the Annual Cardiovascular Conference at Snowmass.
"Calculate an STS score for all patients, as annoying as it is. The goal should be to fit the patient with the best operation, not to force the patient into one technique or the other. The STS score is the only thing we have right now. Work is underway on a new TAVR risk scoring system, but it’s not ready yet," said Dr. Thourani, associate director of cardiothoracic surgery at Emory University, Atlanta.
The STS score was originally developed to predict the risk of mortality in coronary artery bypass graft (CABG) patients. But despite the score’s limitations when applied to patients requiring aortic valve replacement, a new analysis of the massive STS national database demonstrates that the tool is surprisingly accurate for this purpose.
"In reality, the STS score does a pretty good job of predicting what you’re going to do in open surgery. Everybody poo-poos the score, but here we’ve got data on 142,000 patients undergoing isolated surgical aortic valve replacement, and it’s actually pretty close. So I think you can use the STS score for prediction of surgical valve mortality," according to Dr. Thourani.
Among the 141,905 patients in the STS database who underwent isolated surgical aortic valve replacement (SAVR) during roughly the past 6 years, 6% were high risk as defined by an STS predicted risk of mortality score greater than 8%. Another 14% were intermediate risk, with an STS score of 4%-8%. The remaining 80% were low risk, with an STS score of less than 4%.
In a soon-to-be-published report by Dr. Thourani and his coinvestigators, the median postoperative length of stay was 6.0 days in the group with a low-risk STS score, 8.0 days in the intermediate-risk patients, and 9.0 days in those with an STS score greater than 8%. Actual national in-hospital mortality in SAVR patients with an STS score of less than 4% was 1.4%, whereas the mean and median STS for predicted in-hospital mortality in this cohort was 1.7% and 1.5%, respectively. In-hospital mortality in the intermediate-risk group was 5.1%; the mean and median STS scores in this group were 5.5% and 5.2%. And in the high-risk group, in-hospital mortality was 11.8%, compared with 13.7% and 11.2% mean and median predicted rates based on STS scores.
At Emory and other multidisciplinary heart centers around the country, patients needing aortic valve replacement who have an STS score below 4% typically get SAVR with either a stented or sutureless valve. Intermediate-risk patients – those with an STS score of 4%-8% – get SAVR or are enrolled in a mid-risk TAVR clinical trial, provided it’s an option at that site. High-risk patients with an STS score greater than 8% have the option of an open or mini-SAVR, although Dr. Thourani said most of his high-risk patients now undergo TAVR. Extremely high-risk patients having an STS score greater than 15% aren’t candidates for surgery; their options are commercially available TAVR or palliation via balloon valvuloplasty and/or medical therapy.
Patients in need of aortic valve replacement who present to a multidisciplinary heart center undergo an extensive battery of tests aimed at helping the team decide whether SAVR or TAVR is best for that individual. These tests assess relevant factors not included in the STS score algorithm. For example, frailty assessment is not incorporated in the STS score, yet most patients in need of a new aortic valve are elderly. At Emory, patients being evaluated for aortic valve replacement undergo five different measures of frailty: gait speed, grip strength, activities of daily living assessment, nutrition, and the mini–mental status examination. If someone fails three of these five measures, Dr. Thourani rules out the option of SAVR.
Other routine tests include a computed tomography (CT) scan to evaluate the ascending aorta and femoral and iliac arteries for calcification, echocardiography to determine annular sizing, carotid duplex ultrasound, pulmonary function tests, and cardiac catheterization.
TAVR is the best option for patients with porcelain aorta, a hostile chest due to prior radiation therapy, end-stage renal disease, severe lung disease, advanced liver disease, prior CABG surgery with an internal mammary artery graft crossing the midline, more than two prior sternotomies, or moderate dementia.
Dementia is a major issue for patients in their 80s with aortic stenosis warranting valve replacement. Mildly demented patients are suitable for either SAVR or TAVR. Those with severe dementia aren’t candidates for either procedure and are best managed with medication or balloon valvuloplasty.
"We no longer operate on patients with moderate dementia. They sundown really badly. We’ve gone to TAVR in these patients," Dr. Thourani said.
He reported serving as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.
SNOWMASS, COLO. – The Society of Thoracic Surgeons Predicted Risk of Mortality score draws criticism when it’s used to help decide whether a patient should undergo surgical or transcatheter aortic valve replacement, because the algorithm excludes plenty of information pertinent to that task. Yet for now it’s an indispensible tool for cardiologists and surgeons alike, Dr. Vinod H. Thourani asserted at the Annual Cardiovascular Conference at Snowmass.
"Calculate an STS score for all patients, as annoying as it is. The goal should be to fit the patient with the best operation, not to force the patient into one technique or the other. The STS score is the only thing we have right now. Work is underway on a new TAVR risk scoring system, but it’s not ready yet," said Dr. Thourani, associate director of cardiothoracic surgery at Emory University, Atlanta.
The STS score was originally developed to predict the risk of mortality in coronary artery bypass graft (CABG) patients. But despite the score’s limitations when applied to patients requiring aortic valve replacement, a new analysis of the massive STS national database demonstrates that the tool is surprisingly accurate for this purpose.
"In reality, the STS score does a pretty good job of predicting what you’re going to do in open surgery. Everybody poo-poos the score, but here we’ve got data on 142,000 patients undergoing isolated surgical aortic valve replacement, and it’s actually pretty close. So I think you can use the STS score for prediction of surgical valve mortality," according to Dr. Thourani.
Among the 141,905 patients in the STS database who underwent isolated surgical aortic valve replacement (SAVR) during roughly the past 6 years, 6% were high risk as defined by an STS predicted risk of mortality score greater than 8%. Another 14% were intermediate risk, with an STS score of 4%-8%. The remaining 80% were low risk, with an STS score of less than 4%.
In a soon-to-be-published report by Dr. Thourani and his coinvestigators, the median postoperative length of stay was 6.0 days in the group with a low-risk STS score, 8.0 days in the intermediate-risk patients, and 9.0 days in those with an STS score greater than 8%. Actual national in-hospital mortality in SAVR patients with an STS score of less than 4% was 1.4%, whereas the mean and median STS for predicted in-hospital mortality in this cohort was 1.7% and 1.5%, respectively. In-hospital mortality in the intermediate-risk group was 5.1%; the mean and median STS scores in this group were 5.5% and 5.2%. And in the high-risk group, in-hospital mortality was 11.8%, compared with 13.7% and 11.2% mean and median predicted rates based on STS scores.
At Emory and other multidisciplinary heart centers around the country, patients needing aortic valve replacement who have an STS score below 4% typically get SAVR with either a stented or sutureless valve. Intermediate-risk patients – those with an STS score of 4%-8% – get SAVR or are enrolled in a mid-risk TAVR clinical trial, provided it’s an option at that site. High-risk patients with an STS score greater than 8% have the option of an open or mini-SAVR, although Dr. Thourani said most of his high-risk patients now undergo TAVR. Extremely high-risk patients having an STS score greater than 15% aren’t candidates for surgery; their options are commercially available TAVR or palliation via balloon valvuloplasty and/or medical therapy.
Patients in need of aortic valve replacement who present to a multidisciplinary heart center undergo an extensive battery of tests aimed at helping the team decide whether SAVR or TAVR is best for that individual. These tests assess relevant factors not included in the STS score algorithm. For example, frailty assessment is not incorporated in the STS score, yet most patients in need of a new aortic valve are elderly. At Emory, patients being evaluated for aortic valve replacement undergo five different measures of frailty: gait speed, grip strength, activities of daily living assessment, nutrition, and the mini–mental status examination. If someone fails three of these five measures, Dr. Thourani rules out the option of SAVR.
Other routine tests include a computed tomography (CT) scan to evaluate the ascending aorta and femoral and iliac arteries for calcification, echocardiography to determine annular sizing, carotid duplex ultrasound, pulmonary function tests, and cardiac catheterization.
TAVR is the best option for patients with porcelain aorta, a hostile chest due to prior radiation therapy, end-stage renal disease, severe lung disease, advanced liver disease, prior CABG surgery with an internal mammary artery graft crossing the midline, more than two prior sternotomies, or moderate dementia.
Dementia is a major issue for patients in their 80s with aortic stenosis warranting valve replacement. Mildly demented patients are suitable for either SAVR or TAVR. Those with severe dementia aren’t candidates for either procedure and are best managed with medication or balloon valvuloplasty.
"We no longer operate on patients with moderate dementia. They sundown really badly. We’ve gone to TAVR in these patients," Dr. Thourani said.
He reported serving as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.
SNOWMASS, COLO. – The Society of Thoracic Surgeons Predicted Risk of Mortality score draws criticism when it’s used to help decide whether a patient should undergo surgical or transcatheter aortic valve replacement, because the algorithm excludes plenty of information pertinent to that task. Yet for now it’s an indispensible tool for cardiologists and surgeons alike, Dr. Vinod H. Thourani asserted at the Annual Cardiovascular Conference at Snowmass.
"Calculate an STS score for all patients, as annoying as it is. The goal should be to fit the patient with the best operation, not to force the patient into one technique or the other. The STS score is the only thing we have right now. Work is underway on a new TAVR risk scoring system, but it’s not ready yet," said Dr. Thourani, associate director of cardiothoracic surgery at Emory University, Atlanta.
The STS score was originally developed to predict the risk of mortality in coronary artery bypass graft (CABG) patients. But despite the score’s limitations when applied to patients requiring aortic valve replacement, a new analysis of the massive STS national database demonstrates that the tool is surprisingly accurate for this purpose.
"In reality, the STS score does a pretty good job of predicting what you’re going to do in open surgery. Everybody poo-poos the score, but here we’ve got data on 142,000 patients undergoing isolated surgical aortic valve replacement, and it’s actually pretty close. So I think you can use the STS score for prediction of surgical valve mortality," according to Dr. Thourani.
Among the 141,905 patients in the STS database who underwent isolated surgical aortic valve replacement (SAVR) during roughly the past 6 years, 6% were high risk as defined by an STS predicted risk of mortality score greater than 8%. Another 14% were intermediate risk, with an STS score of 4%-8%. The remaining 80% were low risk, with an STS score of less than 4%.
In a soon-to-be-published report by Dr. Thourani and his coinvestigators, the median postoperative length of stay was 6.0 days in the group with a low-risk STS score, 8.0 days in the intermediate-risk patients, and 9.0 days in those with an STS score greater than 8%. Actual national in-hospital mortality in SAVR patients with an STS score of less than 4% was 1.4%, whereas the mean and median STS for predicted in-hospital mortality in this cohort was 1.7% and 1.5%, respectively. In-hospital mortality in the intermediate-risk group was 5.1%; the mean and median STS scores in this group were 5.5% and 5.2%. And in the high-risk group, in-hospital mortality was 11.8%, compared with 13.7% and 11.2% mean and median predicted rates based on STS scores.
At Emory and other multidisciplinary heart centers around the country, patients needing aortic valve replacement who have an STS score below 4% typically get SAVR with either a stented or sutureless valve. Intermediate-risk patients – those with an STS score of 4%-8% – get SAVR or are enrolled in a mid-risk TAVR clinical trial, provided it’s an option at that site. High-risk patients with an STS score greater than 8% have the option of an open or mini-SAVR, although Dr. Thourani said most of his high-risk patients now undergo TAVR. Extremely high-risk patients having an STS score greater than 15% aren’t candidates for surgery; their options are commercially available TAVR or palliation via balloon valvuloplasty and/or medical therapy.
Patients in need of aortic valve replacement who present to a multidisciplinary heart center undergo an extensive battery of tests aimed at helping the team decide whether SAVR or TAVR is best for that individual. These tests assess relevant factors not included in the STS score algorithm. For example, frailty assessment is not incorporated in the STS score, yet most patients in need of a new aortic valve are elderly. At Emory, patients being evaluated for aortic valve replacement undergo five different measures of frailty: gait speed, grip strength, activities of daily living assessment, nutrition, and the mini–mental status examination. If someone fails three of these five measures, Dr. Thourani rules out the option of SAVR.
Other routine tests include a computed tomography (CT) scan to evaluate the ascending aorta and femoral and iliac arteries for calcification, echocardiography to determine annular sizing, carotid duplex ultrasound, pulmonary function tests, and cardiac catheterization.
TAVR is the best option for patients with porcelain aorta, a hostile chest due to prior radiation therapy, end-stage renal disease, severe lung disease, advanced liver disease, prior CABG surgery with an internal mammary artery graft crossing the midline, more than two prior sternotomies, or moderate dementia.
Dementia is a major issue for patients in their 80s with aortic stenosis warranting valve replacement. Mildly demented patients are suitable for either SAVR or TAVR. Those with severe dementia aren’t candidates for either procedure and are best managed with medication or balloon valvuloplasty.
"We no longer operate on patients with moderate dementia. They sundown really badly. We’ve gone to TAVR in these patients," Dr. Thourani said.
He reported serving as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Rising to the challenge of glucose control before and after surgery
SCOTTSDALE, ARIZ. – Controlling hyperglycemia before and after surgery in patients with diabetes is a balancing act, but when done properly, it can reduce infections and wound complications, according to Dr. David Baldwin.
The key to preoperative planning for patients with diabetes is a full list of medications and an understanding of how well (or how poorly) patients’ glycemia is controlled, said Dr. Baldwin, an endocrinologist at Rush University Medical Center in Chicago.
He discussed strategies for perioperative management of patients with diabetes and thyroid disorders at the Perioperative Medicine Summit 2014."You definitely want to write down exactly what they are and aren’t taking. We find that the medication list for people getting admitted for surgery is often fraught with a lack of little details," he said.
For patients with type 2 diabetes, it’s important to record an accurate description of antidiabetes medications, especially combination oral agents such as Actoplus MET (metformin and pioglitazone) or Janumet (sitagliptin and metformin). For patients with type 1 and 2 diabetes, it is important to record not just the type of insulin but the regimen the patient uses.
Dr. Baldwin noted that many intake staff make the mistake of reporting that patients take "Novolin" or "Humulin," which are brand families of insulin and not specific insulin types.
"We often find, probably at least half of the time, that until we actually go and ask the patients what they take for insulin post-op, the correct information won’t have been in the medical record," he said.
The best way to determine whether a patient has good control of chronic hyperglycemia is with a hemoglobin A1c (HbA1c) level. A value above 6.5% is diagnostic for diabetes; well-controlled patients have HbA1c levels from 6% to 8%. HbA1c values not more than 2 months old should be a routine part of preoperative evaluations for patients with diabetes or newly discovered hyperglycemia, Dr. Baldwin said.
Preoperative medications
The Rush University protocol for the preoperative management of antidiabetic therapies other than insulin notes that sulfonylureas, metformin, pioglitazone, exenatide, liraglutide, sitagliptin, linagliptin, saxagliptin, alogliptin, alpha-glucosidase inhibitors, and canagaflozin may all be taken with food on the eve of surgery, but none should be taken on the morning of surgery.
Specific rules also apply for patients who use insulin, depending on the insulin type, as follows:
• For long-acting insulins (glargine or detemir), the patient should take the full dose on the evening before surgery or the morning of surgery if the dose is prescribed for either morning or evening administration. Patients with prescriptions for a b.i.d. dose should take the full dose both the evening before and the morning of surgery.
• With intermediate-acting insulin (NPH), the patient should take the full dose on the evening before surgery and 80% of the morning dose on the morning of surgery.
• For rapid-acting insulins (aspart, lispro, glulisine, or regular) and premixed insulins (NPH or rapid acting), the patient should take the full dose with dinner the night before, and none on the morning of surgery.
Dr. Baldwin emphasized that except in rare circumstances, patients on subcutaneous insulin pumps should not use the pumps during surgery, and should get special instructions from their endocrinologists.
Ideally, the patient can convert to insulin glargine the night before surgery, with the dose equivalent to the total 24-hour basal insulin dose delivered by the pump. Two hours after the glargine dose is given, the patient should disconnect the pump and leave it at home.
Glycemic control in the hospital
As noted before, poor glycemic control can lead to poor wound healing from impaired leukocyte function, which can lead to decreased chemotaxis, phagocytosis, and bacteriocidal activity.
The risk of bacteremia is especially high among patients who are on total parenteral nutrition with poorly controlled glucose levels, he noted.
Forces conspiring against glucose control in the hospital can include elevated levels of hormones that counterregulate glucose; nausea/vomiting, anorexia, or nothing-by-mouth orders; erratic meal timing due to tests or interventions; intravenous glucose; glucocorticoid therapy; and "physician indifference and lack of attention to required adjustments in therapy," Dr. Baldwin noted.
Evidence from a randomized study showed that in patients with type 2 diabetes undergoing general surgery, basal-bolus treatment with insulin glargine once daily plus insulin glulisine before meals both improved glycemic control and reduced hospital complications compared with sliding-scale insulin therapy, he reported.
Hyper- and hypothyroid patients
Switching endocrinology hats, Dr. Baldwin said that patients who have significant weight loss or resting tachycardia before surgery should be evaluated for hyperthyroidism. A good rule of thumb is that in patients with hyperthyroidism, all but emergency procedures should be postponed until the condition can be controlled with methimazole.
Patients with undiagnosed or untreated hyperthyroidism who undergo anesthesia and surgery are at high risk for thyroid storm, a provoked crisis of multiorgan failure, he said.
If the surgery cannot be delayed until elevated levels of thyroxine are achieved, the team can initiate oral or intravenous beta-blockade, or if the patient is in critical condition, infusion with the beta-1 receptor blocker esmolol (Brevibloc) is preferred, he said.
Patients should also be started on methimazole 30-40 mg/day, and the patient should be given iodine if she has not already received iodinated radiologic contrast. Stress dose glucocorticoids and adequate volume resuscitation may also provide support in this situation.
In contrast, "hypothyroidism is usually not a big deal," Dr. Baldwin said.
Such patients usually tolerate major surgery without significant complications, he said, but patients with hypothyroidism may be more sensitive to sedatives, slower to wean from ventilation, and handle free-water excretion less well than euthyroid patients.
Patients who take levothyroxine (Synthroid and generics) should always have their free T4 and thyroid-stimulating hormone (thyrotropin) levels checked during preoperative evaluation, he said.
Dr. Baldwin reported having no relevant financial conflicts of interest.
SCOTTSDALE, ARIZ. – Controlling hyperglycemia before and after surgery in patients with diabetes is a balancing act, but when done properly, it can reduce infections and wound complications, according to Dr. David Baldwin.
The key to preoperative planning for patients with diabetes is a full list of medications and an understanding of how well (or how poorly) patients’ glycemia is controlled, said Dr. Baldwin, an endocrinologist at Rush University Medical Center in Chicago.
He discussed strategies for perioperative management of patients with diabetes and thyroid disorders at the Perioperative Medicine Summit 2014."You definitely want to write down exactly what they are and aren’t taking. We find that the medication list for people getting admitted for surgery is often fraught with a lack of little details," he said.
For patients with type 2 diabetes, it’s important to record an accurate description of antidiabetes medications, especially combination oral agents such as Actoplus MET (metformin and pioglitazone) or Janumet (sitagliptin and metformin). For patients with type 1 and 2 diabetes, it is important to record not just the type of insulin but the regimen the patient uses.
Dr. Baldwin noted that many intake staff make the mistake of reporting that patients take "Novolin" or "Humulin," which are brand families of insulin and not specific insulin types.
"We often find, probably at least half of the time, that until we actually go and ask the patients what they take for insulin post-op, the correct information won’t have been in the medical record," he said.
The best way to determine whether a patient has good control of chronic hyperglycemia is with a hemoglobin A1c (HbA1c) level. A value above 6.5% is diagnostic for diabetes; well-controlled patients have HbA1c levels from 6% to 8%. HbA1c values not more than 2 months old should be a routine part of preoperative evaluations for patients with diabetes or newly discovered hyperglycemia, Dr. Baldwin said.
Preoperative medications
The Rush University protocol for the preoperative management of antidiabetic therapies other than insulin notes that sulfonylureas, metformin, pioglitazone, exenatide, liraglutide, sitagliptin, linagliptin, saxagliptin, alogliptin, alpha-glucosidase inhibitors, and canagaflozin may all be taken with food on the eve of surgery, but none should be taken on the morning of surgery.
Specific rules also apply for patients who use insulin, depending on the insulin type, as follows:
• For long-acting insulins (glargine or detemir), the patient should take the full dose on the evening before surgery or the morning of surgery if the dose is prescribed for either morning or evening administration. Patients with prescriptions for a b.i.d. dose should take the full dose both the evening before and the morning of surgery.
• With intermediate-acting insulin (NPH), the patient should take the full dose on the evening before surgery and 80% of the morning dose on the morning of surgery.
• For rapid-acting insulins (aspart, lispro, glulisine, or regular) and premixed insulins (NPH or rapid acting), the patient should take the full dose with dinner the night before, and none on the morning of surgery.
Dr. Baldwin emphasized that except in rare circumstances, patients on subcutaneous insulin pumps should not use the pumps during surgery, and should get special instructions from their endocrinologists.
Ideally, the patient can convert to insulin glargine the night before surgery, with the dose equivalent to the total 24-hour basal insulin dose delivered by the pump. Two hours after the glargine dose is given, the patient should disconnect the pump and leave it at home.
Glycemic control in the hospital
As noted before, poor glycemic control can lead to poor wound healing from impaired leukocyte function, which can lead to decreased chemotaxis, phagocytosis, and bacteriocidal activity.
The risk of bacteremia is especially high among patients who are on total parenteral nutrition with poorly controlled glucose levels, he noted.
Forces conspiring against glucose control in the hospital can include elevated levels of hormones that counterregulate glucose; nausea/vomiting, anorexia, or nothing-by-mouth orders; erratic meal timing due to tests or interventions; intravenous glucose; glucocorticoid therapy; and "physician indifference and lack of attention to required adjustments in therapy," Dr. Baldwin noted.
Evidence from a randomized study showed that in patients with type 2 diabetes undergoing general surgery, basal-bolus treatment with insulin glargine once daily plus insulin glulisine before meals both improved glycemic control and reduced hospital complications compared with sliding-scale insulin therapy, he reported.
Hyper- and hypothyroid patients
Switching endocrinology hats, Dr. Baldwin said that patients who have significant weight loss or resting tachycardia before surgery should be evaluated for hyperthyroidism. A good rule of thumb is that in patients with hyperthyroidism, all but emergency procedures should be postponed until the condition can be controlled with methimazole.
Patients with undiagnosed or untreated hyperthyroidism who undergo anesthesia and surgery are at high risk for thyroid storm, a provoked crisis of multiorgan failure, he said.
If the surgery cannot be delayed until elevated levels of thyroxine are achieved, the team can initiate oral or intravenous beta-blockade, or if the patient is in critical condition, infusion with the beta-1 receptor blocker esmolol (Brevibloc) is preferred, he said.
Patients should also be started on methimazole 30-40 mg/day, and the patient should be given iodine if she has not already received iodinated radiologic contrast. Stress dose glucocorticoids and adequate volume resuscitation may also provide support in this situation.
In contrast, "hypothyroidism is usually not a big deal," Dr. Baldwin said.
Such patients usually tolerate major surgery without significant complications, he said, but patients with hypothyroidism may be more sensitive to sedatives, slower to wean from ventilation, and handle free-water excretion less well than euthyroid patients.
Patients who take levothyroxine (Synthroid and generics) should always have their free T4 and thyroid-stimulating hormone (thyrotropin) levels checked during preoperative evaluation, he said.
Dr. Baldwin reported having no relevant financial conflicts of interest.
SCOTTSDALE, ARIZ. – Controlling hyperglycemia before and after surgery in patients with diabetes is a balancing act, but when done properly, it can reduce infections and wound complications, according to Dr. David Baldwin.
The key to preoperative planning for patients with diabetes is a full list of medications and an understanding of how well (or how poorly) patients’ glycemia is controlled, said Dr. Baldwin, an endocrinologist at Rush University Medical Center in Chicago.
He discussed strategies for perioperative management of patients with diabetes and thyroid disorders at the Perioperative Medicine Summit 2014."You definitely want to write down exactly what they are and aren’t taking. We find that the medication list for people getting admitted for surgery is often fraught with a lack of little details," he said.
For patients with type 2 diabetes, it’s important to record an accurate description of antidiabetes medications, especially combination oral agents such as Actoplus MET (metformin and pioglitazone) or Janumet (sitagliptin and metformin). For patients with type 1 and 2 diabetes, it is important to record not just the type of insulin but the regimen the patient uses.
Dr. Baldwin noted that many intake staff make the mistake of reporting that patients take "Novolin" or "Humulin," which are brand families of insulin and not specific insulin types.
"We often find, probably at least half of the time, that until we actually go and ask the patients what they take for insulin post-op, the correct information won’t have been in the medical record," he said.
The best way to determine whether a patient has good control of chronic hyperglycemia is with a hemoglobin A1c (HbA1c) level. A value above 6.5% is diagnostic for diabetes; well-controlled patients have HbA1c levels from 6% to 8%. HbA1c values not more than 2 months old should be a routine part of preoperative evaluations for patients with diabetes or newly discovered hyperglycemia, Dr. Baldwin said.
Preoperative medications
The Rush University protocol for the preoperative management of antidiabetic therapies other than insulin notes that sulfonylureas, metformin, pioglitazone, exenatide, liraglutide, sitagliptin, linagliptin, saxagliptin, alogliptin, alpha-glucosidase inhibitors, and canagaflozin may all be taken with food on the eve of surgery, but none should be taken on the morning of surgery.
Specific rules also apply for patients who use insulin, depending on the insulin type, as follows:
• For long-acting insulins (glargine or detemir), the patient should take the full dose on the evening before surgery or the morning of surgery if the dose is prescribed for either morning or evening administration. Patients with prescriptions for a b.i.d. dose should take the full dose both the evening before and the morning of surgery.
• With intermediate-acting insulin (NPH), the patient should take the full dose on the evening before surgery and 80% of the morning dose on the morning of surgery.
• For rapid-acting insulins (aspart, lispro, glulisine, or regular) and premixed insulins (NPH or rapid acting), the patient should take the full dose with dinner the night before, and none on the morning of surgery.
Dr. Baldwin emphasized that except in rare circumstances, patients on subcutaneous insulin pumps should not use the pumps during surgery, and should get special instructions from their endocrinologists.
Ideally, the patient can convert to insulin glargine the night before surgery, with the dose equivalent to the total 24-hour basal insulin dose delivered by the pump. Two hours after the glargine dose is given, the patient should disconnect the pump and leave it at home.
Glycemic control in the hospital
As noted before, poor glycemic control can lead to poor wound healing from impaired leukocyte function, which can lead to decreased chemotaxis, phagocytosis, and bacteriocidal activity.
The risk of bacteremia is especially high among patients who are on total parenteral nutrition with poorly controlled glucose levels, he noted.
Forces conspiring against glucose control in the hospital can include elevated levels of hormones that counterregulate glucose; nausea/vomiting, anorexia, or nothing-by-mouth orders; erratic meal timing due to tests or interventions; intravenous glucose; glucocorticoid therapy; and "physician indifference and lack of attention to required adjustments in therapy," Dr. Baldwin noted.
Evidence from a randomized study showed that in patients with type 2 diabetes undergoing general surgery, basal-bolus treatment with insulin glargine once daily plus insulin glulisine before meals both improved glycemic control and reduced hospital complications compared with sliding-scale insulin therapy, he reported.
Hyper- and hypothyroid patients
Switching endocrinology hats, Dr. Baldwin said that patients who have significant weight loss or resting tachycardia before surgery should be evaluated for hyperthyroidism. A good rule of thumb is that in patients with hyperthyroidism, all but emergency procedures should be postponed until the condition can be controlled with methimazole.
Patients with undiagnosed or untreated hyperthyroidism who undergo anesthesia and surgery are at high risk for thyroid storm, a provoked crisis of multiorgan failure, he said.
If the surgery cannot be delayed until elevated levels of thyroxine are achieved, the team can initiate oral or intravenous beta-blockade, or if the patient is in critical condition, infusion with the beta-1 receptor blocker esmolol (Brevibloc) is preferred, he said.
Patients should also be started on methimazole 30-40 mg/day, and the patient should be given iodine if she has not already received iodinated radiologic contrast. Stress dose glucocorticoids and adequate volume resuscitation may also provide support in this situation.
In contrast, "hypothyroidism is usually not a big deal," Dr. Baldwin said.
Such patients usually tolerate major surgery without significant complications, he said, but patients with hypothyroidism may be more sensitive to sedatives, slower to wean from ventilation, and handle free-water excretion less well than euthyroid patients.
Patients who take levothyroxine (Synthroid and generics) should always have their free T4 and thyroid-stimulating hormone (thyrotropin) levels checked during preoperative evaluation, he said.
Dr. Baldwin reported having no relevant financial conflicts of interest.
AT THE PERIOPERATIVE MEDICINE SUMMIT 2014
Major finding: Patients with diabetes and thyroid disorder require special handling before, during, and after surgery.
Data source: A review of current practice.
Disclosures: Dr. Baldwin reported having no relevant financial conflicts of interest.
