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SHM Seats Its First Non-Physician Board Member
New Society of Hospital Medicine board member Tracy Cardin, ACNP-BC, SFHM, isn’t on the board because she’s a nurse practitioner (NP). But that doesn’t make her election as the first NP or physician assistant (PA) as a voting member of SHM’s oversight panel any less momentous.
“I can’t describe to you how passionately I believe that [NPs and PAs] have a huge role moving forward,” Cardin says. “I think our representation, our visibility, has sort of been flabby and kind of under the wire for a long time. We can really impact the design of care models at the bedside in a way that’s innovative and more efficient and in a way that’s really huge. I think there’s a transformation that’s going to be coming, and we’re going to be a huge part of it.”
Cardin officially started her new position as a board member in March at HM16 in San Diego. She previously—and fittingly—was chair of SHM’s Nurse Practitioner/Physician Assistant Committee. Last year, she received the society’s Award in Excellence in Hospital Medicine for NPs and PAs. She has worked at the University of Chicago for about 10 years.
SHM Past President Robert Harrington Jr., MD, SFHM, who pushed for her inclusion on the board, says that the value of bringing different perspectives to the society’s board can’t be overstated.
“I’m a family medicine–trained hospitalist, and so from firsthand experience, it was important to me before I ever thought about running for the board that there was some representation of our constituency whether that was at the committee level or at the board level,” Dr. Harrington says. “I think that is part of what drew me to seek a higher voice within SHM. … I thought it was important that somebody represent those growing constituencies.”
Dr. Harrington, who among others refers to SHM as a “big tent organization,” says Cardin’s appointment is evidence of that. He believes that his background in family medicine and her background as an NP show healthcare professionals that SHM is not just a group for doctors.
“It does send a message to the rest of our membership that SHM values those other constituencies and that this is not a physician membership organization but rather a membership organization comprised of people who are interested in improving healthcare for our hospitalized patients,” he says.
In fact, Dr. Harrington says one of the first official actions he took as president was to name Cardin an ex officio member of the board. While that meant she could not vote on issues, her perspective alone helped shape conversations.
“Over the course of the last year, she has proven herself to be exactly what I would have hoped she would be: a voice of an important constituency within our membership,” he says. “And as a result of that, [she] ended up being voted into the board.”
Cardin says the time is perfect for her to bring an added viewpoint to the board. First, the number of NPs and PAs is growing.
“NPs and PAs are such a huge part of all acute-care practices,” says Cardin, a past member of Team Hospitalist, the volunteer editorial advisory group for The Hospitalist. “The State of Hospital Medicine surveys showed that 83% of hospitalist groups are utilizing NPs and PAs. I think that is going to be reflected not only in hospitalist practices but in all acute-care practices—there is going to be more deployment and integration of NPs and PAs into practice.
“[SHM] is ahead of the curve recognizing that value.”
Second, healthcare is undergoing payment reform unseen since the introduction of Medicare and Medicaid. Technology is revamping bedside manner, care delivery, and everything in between. And quality of care is more important than ever as doctors will be increasingly paid for how well patients get, not for services provided to them.
“NP and PA providers can have a great impact on care design and throughput as well as other contributions in the hospital environment,” she adds.
Cardin says there can’t be too many educated viewpoints on complicated issues that will affect care delivery in the United States for decades to come. And the first NP/PA voice might be, gulp, just what the doctors ordered.
“We’re at a pivotal time for this organization and also for healthcare in general with the shifts in how we’re paid and what we’re paid for and the complexity of electronic medical records and fragmented healthcare and billing and quality metrics—there’s just so many challenges right now,” she says. “It’s just hugely humbling to be a part of that and try to anticipate what direction that we as a society should go into.” TH
Richard Quinn is a freelance writer based in New Jersey.
New Society of Hospital Medicine board member Tracy Cardin, ACNP-BC, SFHM, isn’t on the board because she’s a nurse practitioner (NP). But that doesn’t make her election as the first NP or physician assistant (PA) as a voting member of SHM’s oversight panel any less momentous.
“I can’t describe to you how passionately I believe that [NPs and PAs] have a huge role moving forward,” Cardin says. “I think our representation, our visibility, has sort of been flabby and kind of under the wire for a long time. We can really impact the design of care models at the bedside in a way that’s innovative and more efficient and in a way that’s really huge. I think there’s a transformation that’s going to be coming, and we’re going to be a huge part of it.”
Cardin officially started her new position as a board member in March at HM16 in San Diego. She previously—and fittingly—was chair of SHM’s Nurse Practitioner/Physician Assistant Committee. Last year, she received the society’s Award in Excellence in Hospital Medicine for NPs and PAs. She has worked at the University of Chicago for about 10 years.
SHM Past President Robert Harrington Jr., MD, SFHM, who pushed for her inclusion on the board, says that the value of bringing different perspectives to the society’s board can’t be overstated.
“I’m a family medicine–trained hospitalist, and so from firsthand experience, it was important to me before I ever thought about running for the board that there was some representation of our constituency whether that was at the committee level or at the board level,” Dr. Harrington says. “I think that is part of what drew me to seek a higher voice within SHM. … I thought it was important that somebody represent those growing constituencies.”
Dr. Harrington, who among others refers to SHM as a “big tent organization,” says Cardin’s appointment is evidence of that. He believes that his background in family medicine and her background as an NP show healthcare professionals that SHM is not just a group for doctors.
“It does send a message to the rest of our membership that SHM values those other constituencies and that this is not a physician membership organization but rather a membership organization comprised of people who are interested in improving healthcare for our hospitalized patients,” he says.
In fact, Dr. Harrington says one of the first official actions he took as president was to name Cardin an ex officio member of the board. While that meant she could not vote on issues, her perspective alone helped shape conversations.
“Over the course of the last year, she has proven herself to be exactly what I would have hoped she would be: a voice of an important constituency within our membership,” he says. “And as a result of that, [she] ended up being voted into the board.”
Cardin says the time is perfect for her to bring an added viewpoint to the board. First, the number of NPs and PAs is growing.
“NPs and PAs are such a huge part of all acute-care practices,” says Cardin, a past member of Team Hospitalist, the volunteer editorial advisory group for The Hospitalist. “The State of Hospital Medicine surveys showed that 83% of hospitalist groups are utilizing NPs and PAs. I think that is going to be reflected not only in hospitalist practices but in all acute-care practices—there is going to be more deployment and integration of NPs and PAs into practice.
“[SHM] is ahead of the curve recognizing that value.”
Second, healthcare is undergoing payment reform unseen since the introduction of Medicare and Medicaid. Technology is revamping bedside manner, care delivery, and everything in between. And quality of care is more important than ever as doctors will be increasingly paid for how well patients get, not for services provided to them.
“NP and PA providers can have a great impact on care design and throughput as well as other contributions in the hospital environment,” she adds.
Cardin says there can’t be too many educated viewpoints on complicated issues that will affect care delivery in the United States for decades to come. And the first NP/PA voice might be, gulp, just what the doctors ordered.
“We’re at a pivotal time for this organization and also for healthcare in general with the shifts in how we’re paid and what we’re paid for and the complexity of electronic medical records and fragmented healthcare and billing and quality metrics—there’s just so many challenges right now,” she says. “It’s just hugely humbling to be a part of that and try to anticipate what direction that we as a society should go into.” TH
Richard Quinn is a freelance writer based in New Jersey.
New Society of Hospital Medicine board member Tracy Cardin, ACNP-BC, SFHM, isn’t on the board because she’s a nurse practitioner (NP). But that doesn’t make her election as the first NP or physician assistant (PA) as a voting member of SHM’s oversight panel any less momentous.
“I can’t describe to you how passionately I believe that [NPs and PAs] have a huge role moving forward,” Cardin says. “I think our representation, our visibility, has sort of been flabby and kind of under the wire for a long time. We can really impact the design of care models at the bedside in a way that’s innovative and more efficient and in a way that’s really huge. I think there’s a transformation that’s going to be coming, and we’re going to be a huge part of it.”
Cardin officially started her new position as a board member in March at HM16 in San Diego. She previously—and fittingly—was chair of SHM’s Nurse Practitioner/Physician Assistant Committee. Last year, she received the society’s Award in Excellence in Hospital Medicine for NPs and PAs. She has worked at the University of Chicago for about 10 years.
SHM Past President Robert Harrington Jr., MD, SFHM, who pushed for her inclusion on the board, says that the value of bringing different perspectives to the society’s board can’t be overstated.
“I’m a family medicine–trained hospitalist, and so from firsthand experience, it was important to me before I ever thought about running for the board that there was some representation of our constituency whether that was at the committee level or at the board level,” Dr. Harrington says. “I think that is part of what drew me to seek a higher voice within SHM. … I thought it was important that somebody represent those growing constituencies.”
Dr. Harrington, who among others refers to SHM as a “big tent organization,” says Cardin’s appointment is evidence of that. He believes that his background in family medicine and her background as an NP show healthcare professionals that SHM is not just a group for doctors.
“It does send a message to the rest of our membership that SHM values those other constituencies and that this is not a physician membership organization but rather a membership organization comprised of people who are interested in improving healthcare for our hospitalized patients,” he says.
In fact, Dr. Harrington says one of the first official actions he took as president was to name Cardin an ex officio member of the board. While that meant she could not vote on issues, her perspective alone helped shape conversations.
“Over the course of the last year, she has proven herself to be exactly what I would have hoped she would be: a voice of an important constituency within our membership,” he says. “And as a result of that, [she] ended up being voted into the board.”
Cardin says the time is perfect for her to bring an added viewpoint to the board. First, the number of NPs and PAs is growing.
“NPs and PAs are such a huge part of all acute-care practices,” says Cardin, a past member of Team Hospitalist, the volunteer editorial advisory group for The Hospitalist. “The State of Hospital Medicine surveys showed that 83% of hospitalist groups are utilizing NPs and PAs. I think that is going to be reflected not only in hospitalist practices but in all acute-care practices—there is going to be more deployment and integration of NPs and PAs into practice.
“[SHM] is ahead of the curve recognizing that value.”
Second, healthcare is undergoing payment reform unseen since the introduction of Medicare and Medicaid. Technology is revamping bedside manner, care delivery, and everything in between. And quality of care is more important than ever as doctors will be increasingly paid for how well patients get, not for services provided to them.
“NP and PA providers can have a great impact on care design and throughput as well as other contributions in the hospital environment,” she adds.
Cardin says there can’t be too many educated viewpoints on complicated issues that will affect care delivery in the United States for decades to come. And the first NP/PA voice might be, gulp, just what the doctors ordered.
“We’re at a pivotal time for this organization and also for healthcare in general with the shifts in how we’re paid and what we’re paid for and the complexity of electronic medical records and fragmented healthcare and billing and quality metrics—there’s just so many challenges right now,” she says. “It’s just hugely humbling to be a part of that and try to anticipate what direction that we as a society should go into.” TH
Richard Quinn is a freelance writer based in New Jersey.
Helicobacter Pylori Treatment is Associated with a Short-term Increase in the Risk of Neuropsychiatic Events
NEW YORK (Reuters Health) - Helicobacter pylori treatment containing clarithromycin is associated with a short-term increase in the risk of neuropsychiatric events, according to a study from Hong Kong.
Neuropsychiatric events following clarithromycin therapy have been reported previously, but no population-based study had assessed the neuropsychiatric risk associated with clarithromycin.
Dr. Esther W. Chan, from Li Ka Shing Faculty of Medicine, University of Hong Kong, and colleagues used data from the University of Hong Kong Clinical Data Analysis and Reporting System to investigate the association between H. pylori therapy containing clarithromycin and acute neuropsychiatric events.
Current use of clarithromycin as part of the H. pylori regimen was associated with a 4.12-fold increased risk of neuropsychiatric events, including a 5.42-fold increase in psychotic events and a 2.63-fold increase in cognitive impairment, compared with baseline.
These increased risks appear to be limited to days 2 to 14 since the prescription start date, according to the May 2 online report in JAMA Internal Medicine.
The crude absolute risks per 1000 prescriptions were 0.45 for neuropsychiatric events, 0.12 for psychotic events, and 0.12 for cognitive impairment during current use of therapy.
"Given the low absolute neuropsychiatric risk, an abrupt change in prescribing practice based on the observed increase in neuropsychiatric events is not suggested, particularly in the absence of better treatment alternatives," the researchers conclude.
"Such transient neuropsychiatric events will usually resolve spontaneously after treatment cessation and psychiatric interventions can be avoided," the authors note.
"Because we investigated H. pylori therapy as the exposure, we could not pinpoint which drug in the regimen contributed to the neuropsychiatric events in our study," they caution. "We hypothesized that clarithromycin is the most probable drug because very limited evidence suggested that neuropsychiatric
events are associated with amoxicillin or proton pump inhibitors."
Dr. Chan was unable to provide comments in time for publication.
The authors reported no funding or disclosures.
NEW YORK (Reuters Health) - Helicobacter pylori treatment containing clarithromycin is associated with a short-term increase in the risk of neuropsychiatric events, according to a study from Hong Kong.
Neuropsychiatric events following clarithromycin therapy have been reported previously, but no population-based study had assessed the neuropsychiatric risk associated with clarithromycin.
Dr. Esther W. Chan, from Li Ka Shing Faculty of Medicine, University of Hong Kong, and colleagues used data from the University of Hong Kong Clinical Data Analysis and Reporting System to investigate the association between H. pylori therapy containing clarithromycin and acute neuropsychiatric events.
Current use of clarithromycin as part of the H. pylori regimen was associated with a 4.12-fold increased risk of neuropsychiatric events, including a 5.42-fold increase in psychotic events and a 2.63-fold increase in cognitive impairment, compared with baseline.
These increased risks appear to be limited to days 2 to 14 since the prescription start date, according to the May 2 online report in JAMA Internal Medicine.
The crude absolute risks per 1000 prescriptions were 0.45 for neuropsychiatric events, 0.12 for psychotic events, and 0.12 for cognitive impairment during current use of therapy.
"Given the low absolute neuropsychiatric risk, an abrupt change in prescribing practice based on the observed increase in neuropsychiatric events is not suggested, particularly in the absence of better treatment alternatives," the researchers conclude.
"Such transient neuropsychiatric events will usually resolve spontaneously after treatment cessation and psychiatric interventions can be avoided," the authors note.
"Because we investigated H. pylori therapy as the exposure, we could not pinpoint which drug in the regimen contributed to the neuropsychiatric events in our study," they caution. "We hypothesized that clarithromycin is the most probable drug because very limited evidence suggested that neuropsychiatric
events are associated with amoxicillin or proton pump inhibitors."
Dr. Chan was unable to provide comments in time for publication.
The authors reported no funding or disclosures.
NEW YORK (Reuters Health) - Helicobacter pylori treatment containing clarithromycin is associated with a short-term increase in the risk of neuropsychiatric events, according to a study from Hong Kong.
Neuropsychiatric events following clarithromycin therapy have been reported previously, but no population-based study had assessed the neuropsychiatric risk associated with clarithromycin.
Dr. Esther W. Chan, from Li Ka Shing Faculty of Medicine, University of Hong Kong, and colleagues used data from the University of Hong Kong Clinical Data Analysis and Reporting System to investigate the association between H. pylori therapy containing clarithromycin and acute neuropsychiatric events.
Current use of clarithromycin as part of the H. pylori regimen was associated with a 4.12-fold increased risk of neuropsychiatric events, including a 5.42-fold increase in psychotic events and a 2.63-fold increase in cognitive impairment, compared with baseline.
These increased risks appear to be limited to days 2 to 14 since the prescription start date, according to the May 2 online report in JAMA Internal Medicine.
The crude absolute risks per 1000 prescriptions were 0.45 for neuropsychiatric events, 0.12 for psychotic events, and 0.12 for cognitive impairment during current use of therapy.
"Given the low absolute neuropsychiatric risk, an abrupt change in prescribing practice based on the observed increase in neuropsychiatric events is not suggested, particularly in the absence of better treatment alternatives," the researchers conclude.
"Such transient neuropsychiatric events will usually resolve spontaneously after treatment cessation and psychiatric interventions can be avoided," the authors note.
"Because we investigated H. pylori therapy as the exposure, we could not pinpoint which drug in the regimen contributed to the neuropsychiatric events in our study," they caution. "We hypothesized that clarithromycin is the most probable drug because very limited evidence suggested that neuropsychiatric
events are associated with amoxicillin or proton pump inhibitors."
Dr. Chan was unable to provide comments in time for publication.
The authors reported no funding or disclosures.
Leadership Academy to Be Held in Florida
A successful hospitalist program requires strong leadership from the floor to the C-suite. SHM’s Leadership Academy prepares clinical and academic leaders with vital skills traditionally not taught in medical school or typical residency programs. This year’s meeting will be held from October 24 to 27 at Disney’s BoardWalk Inn in Lake Buena Vista, Fla. Courses offered include:
- Leadership Foundations: Evaluate your personal leadership strengths and weaknesses, understand key hospital drivers, and more.
- Advanced Leadership: Influential Management: Learn the skills needed to drive culture change through specific leadership behaviors and actions as well as financial storytelling.
(Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)
- Advanced Leadership: Mastering Teamwork: Learn to critically assess program growth opportunities, lead and motivate teams, and design effective communication strategies. (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)
Build the skills and resources necessary to successfully lead and manage a hospital medicine program now and in the future. Learn more at www.shmleadershipacademy.org.
A successful hospitalist program requires strong leadership from the floor to the C-suite. SHM’s Leadership Academy prepares clinical and academic leaders with vital skills traditionally not taught in medical school or typical residency programs. This year’s meeting will be held from October 24 to 27 at Disney’s BoardWalk Inn in Lake Buena Vista, Fla. Courses offered include:
- Leadership Foundations: Evaluate your personal leadership strengths and weaknesses, understand key hospital drivers, and more.
- Advanced Leadership: Influential Management: Learn the skills needed to drive culture change through specific leadership behaviors and actions as well as financial storytelling.
(Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)
- Advanced Leadership: Mastering Teamwork: Learn to critically assess program growth opportunities, lead and motivate teams, and design effective communication strategies. (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)
Build the skills and resources necessary to successfully lead and manage a hospital medicine program now and in the future. Learn more at www.shmleadershipacademy.org.
A successful hospitalist program requires strong leadership from the floor to the C-suite. SHM’s Leadership Academy prepares clinical and academic leaders with vital skills traditionally not taught in medical school or typical residency programs. This year’s meeting will be held from October 24 to 27 at Disney’s BoardWalk Inn in Lake Buena Vista, Fla. Courses offered include:
- Leadership Foundations: Evaluate your personal leadership strengths and weaknesses, understand key hospital drivers, and more.
- Advanced Leadership: Influential Management: Learn the skills needed to drive culture change through specific leadership behaviors and actions as well as financial storytelling.
(Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)
- Advanced Leadership: Mastering Teamwork: Learn to critically assess program growth opportunities, lead and motivate teams, and design effective communication strategies. (Prerequisite: Leadership Foundations or an advanced management degree upon course director approval.)
Build the skills and resources necessary to successfully lead and manage a hospital medicine program now and in the future. Learn more at www.shmleadershipacademy.org.
Hospital Medicine's Movers and Shakers – May 2016
Business Moves
Winter Haven Hospital in Winter Haven, Fla., is now offering pediatric hospitalist services thanks to an agreement with Watson Clinic, based in Lakeland, Fla. The new pediatric unit consists of eight beds and is supervised by three pediatric hospitalists. Winter Haven Hospital is a 468-bed nonprofit hospital and is one of 14 hospitals in the BayCare Health System, which serves the greater Tampa Bay region of Florida.
Business Moves
Winter Haven Hospital in Winter Haven, Fla., is now offering pediatric hospitalist services thanks to an agreement with Watson Clinic, based in Lakeland, Fla. The new pediatric unit consists of eight beds and is supervised by three pediatric hospitalists. Winter Haven Hospital is a 468-bed nonprofit hospital and is one of 14 hospitals in the BayCare Health System, which serves the greater Tampa Bay region of Florida.
Business Moves
Winter Haven Hospital in Winter Haven, Fla., is now offering pediatric hospitalist services thanks to an agreement with Watson Clinic, based in Lakeland, Fla. The new pediatric unit consists of eight beds and is supervised by three pediatric hospitalists. Winter Haven Hospital is a 468-bed nonprofit hospital and is one of 14 hospitals in the BayCare Health System, which serves the greater Tampa Bay region of Florida.
Should Patients Who Develop Postoperative Atrial Fibrillation Start Anticoagulation?
Case
A 66-year-old man with diabetes mellitus type 2 and hypertension underwent left total knee replacement. Several hours after surgery, the patient developed atrial fibrillation (AF). He was asymptomatic, and reversible causes of AF were ruled out. Approximately 18 hours later, he spontaneously reverted back to sinus rhythm. Should this patient, who has no known prior history of AF and a CHA2DS2-VASc score of 3, be started on anticoagulation?
Background
Hospitalists are commonly consulted for evaluation and management of postoperative atrial fibrillation (POAF). The incidence of new-onset AF associated with non-cardiac surgery is approximately 2% and may be more frequent in an elderly population.1 The increased adrenergic tone associated with surgery is thought to elicit AF in some patients. POAF has also been associated with positive fluid balance, electrolyte abnormalities, and hypoxemia.2 Some of these patients will spontaneously revert back to sinus rhythm after these issues are reversed. Others will go on to develop chronic or paroxysmal AF that persists indefinitely. It is also likely that some patients with POAF, in fact, already had asymptomatic AF that was simply undetected prior to hospitalization.
Hospitalists are faced with the difficult task of determining which patients with POAF will benefit from either short-term or long-term anticoagulation. This has not been well studied in postsurgical patients, in contrast to medical patients in whom stroke risk from AF has been very well-characterized. The decision may be further complicated by bleeding risk (associated with either some surgeries or with patient-dependent factors).3
It is worth noting that following major cardiac or thoracic surgery, POAF is common; the incidence ranges from 10% to 60%. In these cases, POAF may be triggered by transient atrial ischemia or by postoperative inflammation and may have a different natural history from POAF in non-cardiac surgery patients in terms of both reversibility and stroke risk. More retrospective data are available regarding cardiothoracic surgery patients.
Previous American Heart Association (AHA) and American College of Cardiology (ACC) guidelines stated that POAF lasting longer than 48 hours warranted anticoagulation. This recommendation was removed from the newest update. The 2014 updated AHA/ACC guidelines are less absolute and now state only that “it is reasonable to administer antithrombotic medication in patients who developed postoperative AF, as recommended for nonsurgical patients” (Level of Evidence: B) in regard to cardiothoracic surgery.4
There is no specific recommendation regarding POAF for non-cardiac surgery patients. The current guidelines are likely purposefully vague due to the lack of direct evidence. The following is a review of the existing literature and a suggested approach to anticoagulation in POAF.
Review
How common is postoperative atrial fibrillation? New-onset AF during hospitalization is known to occur in association with many acute conditions including surgery, infection, and myocardial infarction. About half of the cases of in-hospital new-onset AF are associated with surgery. AF is more commonly seen in surgery that involves the thoracic cavity and cardiac structures. In a cross-sectional epidemiologic study of 22 million patients in California, 20.8% of patients undergoing cardiac surgery developed POAF compared with only 1.3% of patients undergoing non-cardiac surgery.5 A smaller study of non-cardiac surgery patients found a 30-day POAF incidence of 0.37%.2
It is not clear that all of the increase in stroke risk is a direct effect of POAF. Indeed, in a retrospective analysis of almost 3,000 CABG patients, 1.1% suffered a stroke during their hospital stay. Fewer than half of those had a cardiac rhythm other than sinus rhythm. In the 15 stroke patients who developed POAF, nine presented with stroke symptoms prior to the first episode of AF.9 The authors suggest that aggressive anticoagulation for POAF would not have prevented most of these events.
Furthermore, the rate of in-hospital stroke after non-cardiac surgery is probably much lower, though it has not been as well studied. These data raise some questions as to the benefit of anticoagulation in the immediate postoperative period, though it is difficult to draw firm conclusions without randomized data.
What about non-cardiac surgery? There is less evidence available for patients undergoing non-cardiac surgery, but the few studies that do exist also point to higher stroke risk in patients with POAF. A large population-based study using ICD codes found that the one-year risk of stroke for patients with POAF after non-cardiac surgery was 1.47% compared to 0.36% in non-cardiac surgery patients without POAF (P<0.001). Based on these data, the long-term stroke risk after POAF in non-cardiac surgery patients is similar to that of medical AF patients with a CHA2DS2-VASc score of 2. The authors of this study suggest that transient POAF after non-cardiac surgery may carry a long-term stroke risk similar to any other AF diagnosis.10 However, this study design is subject to significant ascertainment bias (i.e., they may have unintentionally captured some patients with preexisting or prolonged AF), and further research is needed to better delineate this risk.
Does increased stroke risk translate into increased mortality? In a retrospective study of 17,000 patients, El-Chami et al found that POAF after CABG was associated with decreased survival after one year (90% versus 96%) and 10 years (55% versus 70%).11 However, those patients who develop POAF may be sicker overall.
Another study showed that death due to stroke occurred in 4.2% of POAF patients compared to 0.2% of non-POAF patients in a five-year period.12 Based on these studies, POAF is likely associated with increased mortality, but there may be other unaccounted variables. Nevertheless, the increased mortality associated with POAF in these populations is similar to that seen for non-surgical population-based studies13 and provides support that those with newly diagnosed AF in the post-surgical setting should at least be followed closely to assess for recurrence.
What is a patient’s risk of developing atrial fibrillation later in life? When we choose to anticoagulate patients with POAF, we then have to determine whether they should be committed to long-term anticoagulation. It is thought that many cases of POAF are transient; however, some patients will go on to have persistent or paroxysmal AF after discharge.
In another study of about 300 CABG patients, about 20% of patients with POAF also went on to develop post-discharge AF, defined as symptomatic AF that led to medical evaluation. As in the previous study, it is likely that there were undetected episodes of AF.14 Thus, in cardiothoracic surgery patients, some but not all of whom develop POAF have recurrent or ongoing AF. For this reason, if anticoagulation is started, it may be reasonable to stop anticoagulation after weeks or months if ongoing AF is not apparent.
What is the risk of postoperative bleeding if anticoagulation is started? Any decision about the benefits of anticoagulation must be weighed against the risks, most notably the risk of serious or life-threatening bleeding. This risk may be heightened in the immediate perioperative period. Discussions should always take place with our surgical colleagues about type of surgery, intraoperative complications, and postoperative risk of bleeding.
Anticoagulation, if indicated, should not be started until postoperative bleeding risk is deemed appropriately low. That said, the 2015 BRIDGE trial (looking at the benefits and risks of “bridging” patients before surgery) provides some peripheral but meaningful information about postoperative bleeding risk. In this study, patients with preexisting AF who underwent low-bleeding-risk surgery and were bridged on day one after surgery with therapeutic doses of unfractionated or low-molecular-weight heparin had a significantly higher risk of postoperative bleeding compared to non-bridged patients, with a number needed to harm of 50.15 It may be reasonable—and likely safer—to wait a couple days to start anticoagulation for patients with POAF.
What is the expert’s opinion? We asked one of our cardiac electrophysiologists what her approach is to this situation. In general, if a patient has a low stroke risk and is in AF for fewer than 24 hours, it is reasonable to defer anticoagulation and follow as an outpatient. Regardless of risk, if AF is sustained for more than 24 hours, we recommend at least four weeks of anticoagulation and close outpatient follow-up, which should include a period of ambulatory monitoring to determine the need for continued anticoagulation. We also recommend considering what comprises the patient’s stroke risk.
For example, if the CHA2DS2-VASc score is 2 but the points come from being a female with coronary artery disease, we would consider forgoing anticoagulation but arranging for an outpatient cardiac monitor with cardiology follow-up. If the patient has a history of stroke or TIA, we recommend continuing anticoagulation indefinitely.
Back to the Case
Given our patient’s episode of POAF lasted fewer than 24 hours, it would be reasonable to hold off starting anticoagulation, but he should be followed as an outpatient with ambulatory monitoring at a minimum, monitoring for recurrence. If he were to develop recurrent AF, then he would warrant anticoagulation based on an annual stroke risk of 3.2% as determined by a CHA2DS2-VASc score of 3.
Bottom Line
Our strategy is as follows: If a patient has a low stroke risk (i.e., CHA2DS2-VASc score <2) and is in AF for fewer than 24 hours, anticoagulation is not started, but outpatient follow-up is arranged to monitor symptoms. Regardless of stroke risk, if a patient is in AF for more than 24 hours, we initiate and continue anticoagulation for a minimum of four weeks and arrange outpatient follow-up with a period of ambulatory monitoring to determine need for continued anticoagulation. If a patient has a high stroke risk (CHA2DS2-VASc >2) or if their risk factors include a history of stroke or TIA, anticoagulation is started and continued indefinitely. Risk-benefit discussion is held with the patient, especially with regard to bleeding risk, prior to anticoagulation initiation. If the individual patient’s situation presents further nuance, we ask for the assistance of our cardiology or cardiac electrophysiology colleagues.
Final Thought
None of the mentioned studies investigated or included newer oral anticoagulants. Risk-benefit ratios may change (potentially considerably) with these agents. Further study is needed. We expect, in due time, studies will look at the question of POAF in regard to newer anticoagulant agents, and perhaps then our decision making will change. TH
Dr. Evavold is a resident in the hospitalist training program, while Dr. Lessing and Dr. Merritt are hospitalists in the Department of Internal Medicine at the University of Colorado. Dr. Tzou is a cardiologist in the section of electrophysiology at the University of Colorado.
References:
- POISE Study Group, Devereaux PJ, Yang H, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008;371(9627):1839-1847. doi:10.1016/s0140-6736(08)60601-7.
- Christians K, Wu B, Quebbeman E, Brasel K. Postoperative atrial fibrillation in noncardiothoracic surgical patients. Am J Surg. 2001;182(6):713-715. doi:10.1016/s0002-9610(01)00799-1.
- Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138(5):1093-1100. doi:10.1378/chest.10-0134.
- Fleisher L, Beckman J, Brown K, et al. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 2002 guidelines on perioperative cardiovascular evaluation for noncardiac surgery). Circulation. 2007;116(17):e418-e500. doi:10.1161/circulationaha.107.185699.
- Walkey A, Benjamin E, Lubitz S. New-onset atrial fibrillation during hospitalization. J Am Coll Cardiol. 2014;64(22):2432-2433. doi:10.1016/j.jacc.2014.09.034.
- Creswell L, Schuessler R, Rosenbloom M, Cox J. Hazards of postoperative atrial arrhythmias. Ann Thorac Surg. 1993;56(3):539-549. doi:10.1016/0003-4975(93)90894-n.
- Almassi G, Schowalter T, Nicolosi A, et al. Atrial fibrillation after cardiac surgery: a major morbid event? Ann Surg. 1997;226(4):501-513.
- Horwich P, Buth K, Légaré J. New onset postoperative atrial fibrillation is associated with a long-term risk for stroke and death following cardiac surgery. J Card Surg. 2013;28(1):8-13. doi:10.1111/jocs.12033.
- Kollar A, Lick S, Vasquez K, Conti V. Relationship of atrial fibrillation and stroke after coronary artery bypass graft surgery: when is anticoagulation indicated? Ann Thorac Surg. 2006;82(2):515-523. doi:10.1016/j.athoracsur.2006.03.037.
- Gialdini G, Nearing K, Bhave P, et al. Perioperative atrial fibrillation and the long-term risk of ischemic stroke. JAMA. 2014;312(6):616. doi:10.1001/jama.2014.9143.
- El-Chami M, Kilgo P, Thourani V, et al. New-onset atrial fibrillation predicts long-term mortality after coronary artery bypass graft. J Am Coll Cardiol. 2010;55(13):1370-1376. doi:10.1016/j.jacc.2009.10.058.
- Ahlsson A, Fengsrud E, Bodin L, Englund A. Postoperative atrial fibrillation in patients undergoing aortocoronary bypass surgery carries an eightfold risk of future atrial fibrillation and a doubled cardiovascular mortality. Euro J Cardiothorac Surg. 2010;37(6):1353-1359. doi:10.1016/j.ejcts.2009.12.033.
- Benjamin EJ, Wolf PA, D’Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998;98(10):946-952.
- Antonelli D, Peres D, Freedberg N, Feldman A, Rosenfeld T. Incidence of postdischarge symptomatic paroxysmal atrial fibrillation in patients who underwent coronary artery bypass graft: long-term follow-up. Pacing Clin Electrophysiol. 2004;27(3):365-367. doi:10.1111/j.1540-8159.2004.00443.x.
- Douketis J, Spyropoulos A, Kaatz S, et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med. 2015;373(9):823-833. doi:10.1056/nejmoa1501035.
Case
A 66-year-old man with diabetes mellitus type 2 and hypertension underwent left total knee replacement. Several hours after surgery, the patient developed atrial fibrillation (AF). He was asymptomatic, and reversible causes of AF were ruled out. Approximately 18 hours later, he spontaneously reverted back to sinus rhythm. Should this patient, who has no known prior history of AF and a CHA2DS2-VASc score of 3, be started on anticoagulation?
Background
Hospitalists are commonly consulted for evaluation and management of postoperative atrial fibrillation (POAF). The incidence of new-onset AF associated with non-cardiac surgery is approximately 2% and may be more frequent in an elderly population.1 The increased adrenergic tone associated with surgery is thought to elicit AF in some patients. POAF has also been associated with positive fluid balance, electrolyte abnormalities, and hypoxemia.2 Some of these patients will spontaneously revert back to sinus rhythm after these issues are reversed. Others will go on to develop chronic or paroxysmal AF that persists indefinitely. It is also likely that some patients with POAF, in fact, already had asymptomatic AF that was simply undetected prior to hospitalization.
Hospitalists are faced with the difficult task of determining which patients with POAF will benefit from either short-term or long-term anticoagulation. This has not been well studied in postsurgical patients, in contrast to medical patients in whom stroke risk from AF has been very well-characterized. The decision may be further complicated by bleeding risk (associated with either some surgeries or with patient-dependent factors).3
It is worth noting that following major cardiac or thoracic surgery, POAF is common; the incidence ranges from 10% to 60%. In these cases, POAF may be triggered by transient atrial ischemia or by postoperative inflammation and may have a different natural history from POAF in non-cardiac surgery patients in terms of both reversibility and stroke risk. More retrospective data are available regarding cardiothoracic surgery patients.
Previous American Heart Association (AHA) and American College of Cardiology (ACC) guidelines stated that POAF lasting longer than 48 hours warranted anticoagulation. This recommendation was removed from the newest update. The 2014 updated AHA/ACC guidelines are less absolute and now state only that “it is reasonable to administer antithrombotic medication in patients who developed postoperative AF, as recommended for nonsurgical patients” (Level of Evidence: B) in regard to cardiothoracic surgery.4
There is no specific recommendation regarding POAF for non-cardiac surgery patients. The current guidelines are likely purposefully vague due to the lack of direct evidence. The following is a review of the existing literature and a suggested approach to anticoagulation in POAF.
Review
How common is postoperative atrial fibrillation? New-onset AF during hospitalization is known to occur in association with many acute conditions including surgery, infection, and myocardial infarction. About half of the cases of in-hospital new-onset AF are associated with surgery. AF is more commonly seen in surgery that involves the thoracic cavity and cardiac structures. In a cross-sectional epidemiologic study of 22 million patients in California, 20.8% of patients undergoing cardiac surgery developed POAF compared with only 1.3% of patients undergoing non-cardiac surgery.5 A smaller study of non-cardiac surgery patients found a 30-day POAF incidence of 0.37%.2
It is not clear that all of the increase in stroke risk is a direct effect of POAF. Indeed, in a retrospective analysis of almost 3,000 CABG patients, 1.1% suffered a stroke during their hospital stay. Fewer than half of those had a cardiac rhythm other than sinus rhythm. In the 15 stroke patients who developed POAF, nine presented with stroke symptoms prior to the first episode of AF.9 The authors suggest that aggressive anticoagulation for POAF would not have prevented most of these events.
Furthermore, the rate of in-hospital stroke after non-cardiac surgery is probably much lower, though it has not been as well studied. These data raise some questions as to the benefit of anticoagulation in the immediate postoperative period, though it is difficult to draw firm conclusions without randomized data.
What about non-cardiac surgery? There is less evidence available for patients undergoing non-cardiac surgery, but the few studies that do exist also point to higher stroke risk in patients with POAF. A large population-based study using ICD codes found that the one-year risk of stroke for patients with POAF after non-cardiac surgery was 1.47% compared to 0.36% in non-cardiac surgery patients without POAF (P<0.001). Based on these data, the long-term stroke risk after POAF in non-cardiac surgery patients is similar to that of medical AF patients with a CHA2DS2-VASc score of 2. The authors of this study suggest that transient POAF after non-cardiac surgery may carry a long-term stroke risk similar to any other AF diagnosis.10 However, this study design is subject to significant ascertainment bias (i.e., they may have unintentionally captured some patients with preexisting or prolonged AF), and further research is needed to better delineate this risk.
Does increased stroke risk translate into increased mortality? In a retrospective study of 17,000 patients, El-Chami et al found that POAF after CABG was associated with decreased survival after one year (90% versus 96%) and 10 years (55% versus 70%).11 However, those patients who develop POAF may be sicker overall.
Another study showed that death due to stroke occurred in 4.2% of POAF patients compared to 0.2% of non-POAF patients in a five-year period.12 Based on these studies, POAF is likely associated with increased mortality, but there may be other unaccounted variables. Nevertheless, the increased mortality associated with POAF in these populations is similar to that seen for non-surgical population-based studies13 and provides support that those with newly diagnosed AF in the post-surgical setting should at least be followed closely to assess for recurrence.
What is a patient’s risk of developing atrial fibrillation later in life? When we choose to anticoagulate patients with POAF, we then have to determine whether they should be committed to long-term anticoagulation. It is thought that many cases of POAF are transient; however, some patients will go on to have persistent or paroxysmal AF after discharge.
In another study of about 300 CABG patients, about 20% of patients with POAF also went on to develop post-discharge AF, defined as symptomatic AF that led to medical evaluation. As in the previous study, it is likely that there were undetected episodes of AF.14 Thus, in cardiothoracic surgery patients, some but not all of whom develop POAF have recurrent or ongoing AF. For this reason, if anticoagulation is started, it may be reasonable to stop anticoagulation after weeks or months if ongoing AF is not apparent.
What is the risk of postoperative bleeding if anticoagulation is started? Any decision about the benefits of anticoagulation must be weighed against the risks, most notably the risk of serious or life-threatening bleeding. This risk may be heightened in the immediate perioperative period. Discussions should always take place with our surgical colleagues about type of surgery, intraoperative complications, and postoperative risk of bleeding.
Anticoagulation, if indicated, should not be started until postoperative bleeding risk is deemed appropriately low. That said, the 2015 BRIDGE trial (looking at the benefits and risks of “bridging” patients before surgery) provides some peripheral but meaningful information about postoperative bleeding risk. In this study, patients with preexisting AF who underwent low-bleeding-risk surgery and were bridged on day one after surgery with therapeutic doses of unfractionated or low-molecular-weight heparin had a significantly higher risk of postoperative bleeding compared to non-bridged patients, with a number needed to harm of 50.15 It may be reasonable—and likely safer—to wait a couple days to start anticoagulation for patients with POAF.
What is the expert’s opinion? We asked one of our cardiac electrophysiologists what her approach is to this situation. In general, if a patient has a low stroke risk and is in AF for fewer than 24 hours, it is reasonable to defer anticoagulation and follow as an outpatient. Regardless of risk, if AF is sustained for more than 24 hours, we recommend at least four weeks of anticoagulation and close outpatient follow-up, which should include a period of ambulatory monitoring to determine the need for continued anticoagulation. We also recommend considering what comprises the patient’s stroke risk.
For example, if the CHA2DS2-VASc score is 2 but the points come from being a female with coronary artery disease, we would consider forgoing anticoagulation but arranging for an outpatient cardiac monitor with cardiology follow-up. If the patient has a history of stroke or TIA, we recommend continuing anticoagulation indefinitely.
Back to the Case
Given our patient’s episode of POAF lasted fewer than 24 hours, it would be reasonable to hold off starting anticoagulation, but he should be followed as an outpatient with ambulatory monitoring at a minimum, monitoring for recurrence. If he were to develop recurrent AF, then he would warrant anticoagulation based on an annual stroke risk of 3.2% as determined by a CHA2DS2-VASc score of 3.
Bottom Line
Our strategy is as follows: If a patient has a low stroke risk (i.e., CHA2DS2-VASc score <2) and is in AF for fewer than 24 hours, anticoagulation is not started, but outpatient follow-up is arranged to monitor symptoms. Regardless of stroke risk, if a patient is in AF for more than 24 hours, we initiate and continue anticoagulation for a minimum of four weeks and arrange outpatient follow-up with a period of ambulatory monitoring to determine need for continued anticoagulation. If a patient has a high stroke risk (CHA2DS2-VASc >2) or if their risk factors include a history of stroke or TIA, anticoagulation is started and continued indefinitely. Risk-benefit discussion is held with the patient, especially with regard to bleeding risk, prior to anticoagulation initiation. If the individual patient’s situation presents further nuance, we ask for the assistance of our cardiology or cardiac electrophysiology colleagues.
Final Thought
None of the mentioned studies investigated or included newer oral anticoagulants. Risk-benefit ratios may change (potentially considerably) with these agents. Further study is needed. We expect, in due time, studies will look at the question of POAF in regard to newer anticoagulant agents, and perhaps then our decision making will change. TH
Dr. Evavold is a resident in the hospitalist training program, while Dr. Lessing and Dr. Merritt are hospitalists in the Department of Internal Medicine at the University of Colorado. Dr. Tzou is a cardiologist in the section of electrophysiology at the University of Colorado.
References:
- POISE Study Group, Devereaux PJ, Yang H, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008;371(9627):1839-1847. doi:10.1016/s0140-6736(08)60601-7.
- Christians K, Wu B, Quebbeman E, Brasel K. Postoperative atrial fibrillation in noncardiothoracic surgical patients. Am J Surg. 2001;182(6):713-715. doi:10.1016/s0002-9610(01)00799-1.
- Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138(5):1093-1100. doi:10.1378/chest.10-0134.
- Fleisher L, Beckman J, Brown K, et al. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 2002 guidelines on perioperative cardiovascular evaluation for noncardiac surgery). Circulation. 2007;116(17):e418-e500. doi:10.1161/circulationaha.107.185699.
- Walkey A, Benjamin E, Lubitz S. New-onset atrial fibrillation during hospitalization. J Am Coll Cardiol. 2014;64(22):2432-2433. doi:10.1016/j.jacc.2014.09.034.
- Creswell L, Schuessler R, Rosenbloom M, Cox J. Hazards of postoperative atrial arrhythmias. Ann Thorac Surg. 1993;56(3):539-549. doi:10.1016/0003-4975(93)90894-n.
- Almassi G, Schowalter T, Nicolosi A, et al. Atrial fibrillation after cardiac surgery: a major morbid event? Ann Surg. 1997;226(4):501-513.
- Horwich P, Buth K, Légaré J. New onset postoperative atrial fibrillation is associated with a long-term risk for stroke and death following cardiac surgery. J Card Surg. 2013;28(1):8-13. doi:10.1111/jocs.12033.
- Kollar A, Lick S, Vasquez K, Conti V. Relationship of atrial fibrillation and stroke after coronary artery bypass graft surgery: when is anticoagulation indicated? Ann Thorac Surg. 2006;82(2):515-523. doi:10.1016/j.athoracsur.2006.03.037.
- Gialdini G, Nearing K, Bhave P, et al. Perioperative atrial fibrillation and the long-term risk of ischemic stroke. JAMA. 2014;312(6):616. doi:10.1001/jama.2014.9143.
- El-Chami M, Kilgo P, Thourani V, et al. New-onset atrial fibrillation predicts long-term mortality after coronary artery bypass graft. J Am Coll Cardiol. 2010;55(13):1370-1376. doi:10.1016/j.jacc.2009.10.058.
- Ahlsson A, Fengsrud E, Bodin L, Englund A. Postoperative atrial fibrillation in patients undergoing aortocoronary bypass surgery carries an eightfold risk of future atrial fibrillation and a doubled cardiovascular mortality. Euro J Cardiothorac Surg. 2010;37(6):1353-1359. doi:10.1016/j.ejcts.2009.12.033.
- Benjamin EJ, Wolf PA, D’Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998;98(10):946-952.
- Antonelli D, Peres D, Freedberg N, Feldman A, Rosenfeld T. Incidence of postdischarge symptomatic paroxysmal atrial fibrillation in patients who underwent coronary artery bypass graft: long-term follow-up. Pacing Clin Electrophysiol. 2004;27(3):365-367. doi:10.1111/j.1540-8159.2004.00443.x.
- Douketis J, Spyropoulos A, Kaatz S, et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med. 2015;373(9):823-833. doi:10.1056/nejmoa1501035.
Case
A 66-year-old man with diabetes mellitus type 2 and hypertension underwent left total knee replacement. Several hours after surgery, the patient developed atrial fibrillation (AF). He was asymptomatic, and reversible causes of AF were ruled out. Approximately 18 hours later, he spontaneously reverted back to sinus rhythm. Should this patient, who has no known prior history of AF and a CHA2DS2-VASc score of 3, be started on anticoagulation?
Background
Hospitalists are commonly consulted for evaluation and management of postoperative atrial fibrillation (POAF). The incidence of new-onset AF associated with non-cardiac surgery is approximately 2% and may be more frequent in an elderly population.1 The increased adrenergic tone associated with surgery is thought to elicit AF in some patients. POAF has also been associated with positive fluid balance, electrolyte abnormalities, and hypoxemia.2 Some of these patients will spontaneously revert back to sinus rhythm after these issues are reversed. Others will go on to develop chronic or paroxysmal AF that persists indefinitely. It is also likely that some patients with POAF, in fact, already had asymptomatic AF that was simply undetected prior to hospitalization.
Hospitalists are faced with the difficult task of determining which patients with POAF will benefit from either short-term or long-term anticoagulation. This has not been well studied in postsurgical patients, in contrast to medical patients in whom stroke risk from AF has been very well-characterized. The decision may be further complicated by bleeding risk (associated with either some surgeries or with patient-dependent factors).3
It is worth noting that following major cardiac or thoracic surgery, POAF is common; the incidence ranges from 10% to 60%. In these cases, POAF may be triggered by transient atrial ischemia or by postoperative inflammation and may have a different natural history from POAF in non-cardiac surgery patients in terms of both reversibility and stroke risk. More retrospective data are available regarding cardiothoracic surgery patients.
Previous American Heart Association (AHA) and American College of Cardiology (ACC) guidelines stated that POAF lasting longer than 48 hours warranted anticoagulation. This recommendation was removed from the newest update. The 2014 updated AHA/ACC guidelines are less absolute and now state only that “it is reasonable to administer antithrombotic medication in patients who developed postoperative AF, as recommended for nonsurgical patients” (Level of Evidence: B) in regard to cardiothoracic surgery.4
There is no specific recommendation regarding POAF for non-cardiac surgery patients. The current guidelines are likely purposefully vague due to the lack of direct evidence. The following is a review of the existing literature and a suggested approach to anticoagulation in POAF.
Review
How common is postoperative atrial fibrillation? New-onset AF during hospitalization is known to occur in association with many acute conditions including surgery, infection, and myocardial infarction. About half of the cases of in-hospital new-onset AF are associated with surgery. AF is more commonly seen in surgery that involves the thoracic cavity and cardiac structures. In a cross-sectional epidemiologic study of 22 million patients in California, 20.8% of patients undergoing cardiac surgery developed POAF compared with only 1.3% of patients undergoing non-cardiac surgery.5 A smaller study of non-cardiac surgery patients found a 30-day POAF incidence of 0.37%.2
It is not clear that all of the increase in stroke risk is a direct effect of POAF. Indeed, in a retrospective analysis of almost 3,000 CABG patients, 1.1% suffered a stroke during their hospital stay. Fewer than half of those had a cardiac rhythm other than sinus rhythm. In the 15 stroke patients who developed POAF, nine presented with stroke symptoms prior to the first episode of AF.9 The authors suggest that aggressive anticoagulation for POAF would not have prevented most of these events.
Furthermore, the rate of in-hospital stroke after non-cardiac surgery is probably much lower, though it has not been as well studied. These data raise some questions as to the benefit of anticoagulation in the immediate postoperative period, though it is difficult to draw firm conclusions without randomized data.
What about non-cardiac surgery? There is less evidence available for patients undergoing non-cardiac surgery, but the few studies that do exist also point to higher stroke risk in patients with POAF. A large population-based study using ICD codes found that the one-year risk of stroke for patients with POAF after non-cardiac surgery was 1.47% compared to 0.36% in non-cardiac surgery patients without POAF (P<0.001). Based on these data, the long-term stroke risk after POAF in non-cardiac surgery patients is similar to that of medical AF patients with a CHA2DS2-VASc score of 2. The authors of this study suggest that transient POAF after non-cardiac surgery may carry a long-term stroke risk similar to any other AF diagnosis.10 However, this study design is subject to significant ascertainment bias (i.e., they may have unintentionally captured some patients with preexisting or prolonged AF), and further research is needed to better delineate this risk.
Does increased stroke risk translate into increased mortality? In a retrospective study of 17,000 patients, El-Chami et al found that POAF after CABG was associated with decreased survival after one year (90% versus 96%) and 10 years (55% versus 70%).11 However, those patients who develop POAF may be sicker overall.
Another study showed that death due to stroke occurred in 4.2% of POAF patients compared to 0.2% of non-POAF patients in a five-year period.12 Based on these studies, POAF is likely associated with increased mortality, but there may be other unaccounted variables. Nevertheless, the increased mortality associated with POAF in these populations is similar to that seen for non-surgical population-based studies13 and provides support that those with newly diagnosed AF in the post-surgical setting should at least be followed closely to assess for recurrence.
What is a patient’s risk of developing atrial fibrillation later in life? When we choose to anticoagulate patients with POAF, we then have to determine whether they should be committed to long-term anticoagulation. It is thought that many cases of POAF are transient; however, some patients will go on to have persistent or paroxysmal AF after discharge.
In another study of about 300 CABG patients, about 20% of patients with POAF also went on to develop post-discharge AF, defined as symptomatic AF that led to medical evaluation. As in the previous study, it is likely that there were undetected episodes of AF.14 Thus, in cardiothoracic surgery patients, some but not all of whom develop POAF have recurrent or ongoing AF. For this reason, if anticoagulation is started, it may be reasonable to stop anticoagulation after weeks or months if ongoing AF is not apparent.
What is the risk of postoperative bleeding if anticoagulation is started? Any decision about the benefits of anticoagulation must be weighed against the risks, most notably the risk of serious or life-threatening bleeding. This risk may be heightened in the immediate perioperative period. Discussions should always take place with our surgical colleagues about type of surgery, intraoperative complications, and postoperative risk of bleeding.
Anticoagulation, if indicated, should not be started until postoperative bleeding risk is deemed appropriately low. That said, the 2015 BRIDGE trial (looking at the benefits and risks of “bridging” patients before surgery) provides some peripheral but meaningful information about postoperative bleeding risk. In this study, patients with preexisting AF who underwent low-bleeding-risk surgery and were bridged on day one after surgery with therapeutic doses of unfractionated or low-molecular-weight heparin had a significantly higher risk of postoperative bleeding compared to non-bridged patients, with a number needed to harm of 50.15 It may be reasonable—and likely safer—to wait a couple days to start anticoagulation for patients with POAF.
What is the expert’s opinion? We asked one of our cardiac electrophysiologists what her approach is to this situation. In general, if a patient has a low stroke risk and is in AF for fewer than 24 hours, it is reasonable to defer anticoagulation and follow as an outpatient. Regardless of risk, if AF is sustained for more than 24 hours, we recommend at least four weeks of anticoagulation and close outpatient follow-up, which should include a period of ambulatory monitoring to determine the need for continued anticoagulation. We also recommend considering what comprises the patient’s stroke risk.
For example, if the CHA2DS2-VASc score is 2 but the points come from being a female with coronary artery disease, we would consider forgoing anticoagulation but arranging for an outpatient cardiac monitor with cardiology follow-up. If the patient has a history of stroke or TIA, we recommend continuing anticoagulation indefinitely.
Back to the Case
Given our patient’s episode of POAF lasted fewer than 24 hours, it would be reasonable to hold off starting anticoagulation, but he should be followed as an outpatient with ambulatory monitoring at a minimum, monitoring for recurrence. If he were to develop recurrent AF, then he would warrant anticoagulation based on an annual stroke risk of 3.2% as determined by a CHA2DS2-VASc score of 3.
Bottom Line
Our strategy is as follows: If a patient has a low stroke risk (i.e., CHA2DS2-VASc score <2) and is in AF for fewer than 24 hours, anticoagulation is not started, but outpatient follow-up is arranged to monitor symptoms. Regardless of stroke risk, if a patient is in AF for more than 24 hours, we initiate and continue anticoagulation for a minimum of four weeks and arrange outpatient follow-up with a period of ambulatory monitoring to determine need for continued anticoagulation. If a patient has a high stroke risk (CHA2DS2-VASc >2) or if their risk factors include a history of stroke or TIA, anticoagulation is started and continued indefinitely. Risk-benefit discussion is held with the patient, especially with regard to bleeding risk, prior to anticoagulation initiation. If the individual patient’s situation presents further nuance, we ask for the assistance of our cardiology or cardiac electrophysiology colleagues.
Final Thought
None of the mentioned studies investigated or included newer oral anticoagulants. Risk-benefit ratios may change (potentially considerably) with these agents. Further study is needed. We expect, in due time, studies will look at the question of POAF in regard to newer anticoagulant agents, and perhaps then our decision making will change. TH
Dr. Evavold is a resident in the hospitalist training program, while Dr. Lessing and Dr. Merritt are hospitalists in the Department of Internal Medicine at the University of Colorado. Dr. Tzou is a cardiologist in the section of electrophysiology at the University of Colorado.
References:
- POISE Study Group, Devereaux PJ, Yang H, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008;371(9627):1839-1847. doi:10.1016/s0140-6736(08)60601-7.
- Christians K, Wu B, Quebbeman E, Brasel K. Postoperative atrial fibrillation in noncardiothoracic surgical patients. Am J Surg. 2001;182(6):713-715. doi:10.1016/s0002-9610(01)00799-1.
- Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138(5):1093-1100. doi:10.1378/chest.10-0134.
- Fleisher L, Beckman J, Brown K, et al. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 2002 guidelines on perioperative cardiovascular evaluation for noncardiac surgery). Circulation. 2007;116(17):e418-e500. doi:10.1161/circulationaha.107.185699.
- Walkey A, Benjamin E, Lubitz S. New-onset atrial fibrillation during hospitalization. J Am Coll Cardiol. 2014;64(22):2432-2433. doi:10.1016/j.jacc.2014.09.034.
- Creswell L, Schuessler R, Rosenbloom M, Cox J. Hazards of postoperative atrial arrhythmias. Ann Thorac Surg. 1993;56(3):539-549. doi:10.1016/0003-4975(93)90894-n.
- Almassi G, Schowalter T, Nicolosi A, et al. Atrial fibrillation after cardiac surgery: a major morbid event? Ann Surg. 1997;226(4):501-513.
- Horwich P, Buth K, Légaré J. New onset postoperative atrial fibrillation is associated with a long-term risk for stroke and death following cardiac surgery. J Card Surg. 2013;28(1):8-13. doi:10.1111/jocs.12033.
- Kollar A, Lick S, Vasquez K, Conti V. Relationship of atrial fibrillation and stroke after coronary artery bypass graft surgery: when is anticoagulation indicated? Ann Thorac Surg. 2006;82(2):515-523. doi:10.1016/j.athoracsur.2006.03.037.
- Gialdini G, Nearing K, Bhave P, et al. Perioperative atrial fibrillation and the long-term risk of ischemic stroke. JAMA. 2014;312(6):616. doi:10.1001/jama.2014.9143.
- El-Chami M, Kilgo P, Thourani V, et al. New-onset atrial fibrillation predicts long-term mortality after coronary artery bypass graft. J Am Coll Cardiol. 2010;55(13):1370-1376. doi:10.1016/j.jacc.2009.10.058.
- Ahlsson A, Fengsrud E, Bodin L, Englund A. Postoperative atrial fibrillation in patients undergoing aortocoronary bypass surgery carries an eightfold risk of future atrial fibrillation and a doubled cardiovascular mortality. Euro J Cardiothorac Surg. 2010;37(6):1353-1359. doi:10.1016/j.ejcts.2009.12.033.
- Benjamin EJ, Wolf PA, D’Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998;98(10):946-952.
- Antonelli D, Peres D, Freedberg N, Feldman A, Rosenfeld T. Incidence of postdischarge symptomatic paroxysmal atrial fibrillation in patients who underwent coronary artery bypass graft: long-term follow-up. Pacing Clin Electrophysiol. 2004;27(3):365-367. doi:10.1111/j.1540-8159.2004.00443.x.
- Douketis J, Spyropoulos A, Kaatz S, et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med. 2015;373(9):823-833. doi:10.1056/nejmoa1501035.
8 Lessons for Hospitalists Turned Entrepreneurs
If you are a hospitalist, you are an entrepreneur almost by definition. All hospitalists are continuously engaged in improving the hospital experience for our patients. For some of us, the inner entrepreneur may grow to a point where we seriously consider a part-time or full-time commitment to an entrepreneurial dream. Combining our years of immersion in hospital patient care with an inventive streak can be a potent recipe for an innovative product or service idea.
It may be that the burgeoning startup scene in healthcare has inspired your dream. From coast to coast, there are startup incubators such as Rock Health, Healthbox, Blueprint Health, StartUp Health, Health Wildcatters, The Iron Yard, and TechSpring. These outfits support entrepreneurs with mentorship, funding, workspace, and/or information, such as how to deal with HIPAA or the FDA. Most of us have had at least a passing fascination with Steve Jobs–type characters, individuals who changed the world through their vision and force of will or who just seemed to enjoy a freedom that those who work for “The Man” will never know.
A few years ago, I caught the entrepreneurial bug. Initially, I continued with my day job and worked nights and weekends on my side project. Eventually, I made the leap to work full-time at an early-stage healthcare company. Since then, I’ve spent a lot of time trying to improve my new practice as a full-time entrepreneur, working as hard as ever, trying to be an effective innovator. Every day seems to bring new lessons—some more hard-earned than others—and there’s a lifetime of them still ahead. I’d like to share some of the insights I have learned on this journey. By the way, I still make time for patient care since that remains a priority for me.
Patience Is a Virtue, but Persistence and Positivity Count Even More
As Henry David Thoreau wrote, “Go confidently in the direction of your dreams.” Don’t postpone action indefinitely just because there are obstacles. Stop making excuses, make a start, and build momentum every day. Commit.
Becoming an entrepreneur is a long-term effort fueled by dedication and optimism, but first you have to make a start. You can’t win if you don’t play.
Action and Learning Matter More than Ideation
Start with your idea and a rough plan, but above all, believe in yourself, especially your ability to problem-solve. Many of the qualities that have fueled our success as physicians—precision, thoughtfulness, error aversion, and compulsiveness—might be constraints in a startup environment. Startups are hostile places for perfectionists and those who require complete information before proceeding. Have a bias for action and become comfortable with ambiguity. Entrepreneurs turn little things into big things by making progress every day.
Perhaps contrary to what we learn as physicians, entrepreneurs understand progress is measured more by authentic learning than by getting particular results. Entrepreneurs must quickly learn how to fail. In fact, progress often resembles multiple experiments that allow you to fail (and learn) faster. For entrepreneurs, perfection truly is the enemy of the good.
Learn, make adjustments, and progress will follow.
Guidance Is More Valuable than Money
Commercializing an idea is a challenging proposition. First-timers need advice, support, and help. For advice, find a mentor who has successfully launched a startup. Most of the successful people I know have had the wisdom or good fortune to have a mentor to provide guidance.
Startup incubators can be another source of support. Nearly all large cities and many medium and small cities now have business incubators or accelerators. Attend an event and get involved. They will provide many of the tools you will need to get started.
There are lots of opportunities for innovation in healthcare. But commercializing an idea will be one of the most challenging things you’ll ever do. Surround yourself with people who have skills that complement yours. Physician entrepreneurs need to be part of a viable team.
Sell, Sell, Sell
In business, as in life, “we’re all in sales.” We sell our ideas, our work product, ourselves. Even as physicians we have to sell patients and colleagues on our thought processes to be successful. Successful entrepreneurs are comfortable selling and put their best foot forward when trying to recruit a resource or persuade a potential customer.
Conflicts of Interest
“There is no interest without conflict.” If you look hard enough, you’ll see that we all have conflicts of interest. The key is to recognize them and disclose them. Of course, there are certain conflicts that are deal breakers. They must be avoided. If you remain employed, most of them are spelled out in your employer’s conflict of interest and intellectual property policies.
HIPAA Is an Innovation Killer
If your idea involves technology or services that address protected health information, become a HIPAA savant as soon as possible. The good news is that if you can effectively navigate the HIPAA challenge, you will have an advantage over your competitors.
Pure ‘Tech’ Plays Are Difficult
If you want to try to build the next killer app for healthcare and hope it will go viral, good luck. Based on my experience, it is difficult to get market traction with a pure technology offering. The strategy with a higher likelihood of success is to provide services with a technology platform that supports those services. As a provider of a service, you can provide immediate value to the customer and become “sticky” as you build your business (and software).
Enjoy the Journey, No Matter What
At first, you will be propelled by irrational exuberance and a passion for the greatness of your idea. That’s not only a good thing, it’s a requirement. But becoming a successful entrepreneur is a heavy haul down a long road of hard work and execution. Enjoying the journey is crucial since, beyond that, there are no guarantees. But life is short, so maybe you also value a career with no regrets. Take a chance and enjoy the ride.
Being a physician entrepreneur is not for everyone. But for those who take the plunge, it can be one of the most fulfilling, exciting, and meaningful journeys one could imagine. TH
Author note: I’d like to thank Dr. Jason Stein and Joe Miller for their helpful comments on this column.
If you are a hospitalist, you are an entrepreneur almost by definition. All hospitalists are continuously engaged in improving the hospital experience for our patients. For some of us, the inner entrepreneur may grow to a point where we seriously consider a part-time or full-time commitment to an entrepreneurial dream. Combining our years of immersion in hospital patient care with an inventive streak can be a potent recipe for an innovative product or service idea.
It may be that the burgeoning startup scene in healthcare has inspired your dream. From coast to coast, there are startup incubators such as Rock Health, Healthbox, Blueprint Health, StartUp Health, Health Wildcatters, The Iron Yard, and TechSpring. These outfits support entrepreneurs with mentorship, funding, workspace, and/or information, such as how to deal with HIPAA or the FDA. Most of us have had at least a passing fascination with Steve Jobs–type characters, individuals who changed the world through their vision and force of will or who just seemed to enjoy a freedom that those who work for “The Man” will never know.
A few years ago, I caught the entrepreneurial bug. Initially, I continued with my day job and worked nights and weekends on my side project. Eventually, I made the leap to work full-time at an early-stage healthcare company. Since then, I’ve spent a lot of time trying to improve my new practice as a full-time entrepreneur, working as hard as ever, trying to be an effective innovator. Every day seems to bring new lessons—some more hard-earned than others—and there’s a lifetime of them still ahead. I’d like to share some of the insights I have learned on this journey. By the way, I still make time for patient care since that remains a priority for me.
Patience Is a Virtue, but Persistence and Positivity Count Even More
As Henry David Thoreau wrote, “Go confidently in the direction of your dreams.” Don’t postpone action indefinitely just because there are obstacles. Stop making excuses, make a start, and build momentum every day. Commit.
Becoming an entrepreneur is a long-term effort fueled by dedication and optimism, but first you have to make a start. You can’t win if you don’t play.
Action and Learning Matter More than Ideation
Start with your idea and a rough plan, but above all, believe in yourself, especially your ability to problem-solve. Many of the qualities that have fueled our success as physicians—precision, thoughtfulness, error aversion, and compulsiveness—might be constraints in a startup environment. Startups are hostile places for perfectionists and those who require complete information before proceeding. Have a bias for action and become comfortable with ambiguity. Entrepreneurs turn little things into big things by making progress every day.
Perhaps contrary to what we learn as physicians, entrepreneurs understand progress is measured more by authentic learning than by getting particular results. Entrepreneurs must quickly learn how to fail. In fact, progress often resembles multiple experiments that allow you to fail (and learn) faster. For entrepreneurs, perfection truly is the enemy of the good.
Learn, make adjustments, and progress will follow.
Guidance Is More Valuable than Money
Commercializing an idea is a challenging proposition. First-timers need advice, support, and help. For advice, find a mentor who has successfully launched a startup. Most of the successful people I know have had the wisdom or good fortune to have a mentor to provide guidance.
Startup incubators can be another source of support. Nearly all large cities and many medium and small cities now have business incubators or accelerators. Attend an event and get involved. They will provide many of the tools you will need to get started.
There are lots of opportunities for innovation in healthcare. But commercializing an idea will be one of the most challenging things you’ll ever do. Surround yourself with people who have skills that complement yours. Physician entrepreneurs need to be part of a viable team.
Sell, Sell, Sell
In business, as in life, “we’re all in sales.” We sell our ideas, our work product, ourselves. Even as physicians we have to sell patients and colleagues on our thought processes to be successful. Successful entrepreneurs are comfortable selling and put their best foot forward when trying to recruit a resource or persuade a potential customer.
Conflicts of Interest
“There is no interest without conflict.” If you look hard enough, you’ll see that we all have conflicts of interest. The key is to recognize them and disclose them. Of course, there are certain conflicts that are deal breakers. They must be avoided. If you remain employed, most of them are spelled out in your employer’s conflict of interest and intellectual property policies.
HIPAA Is an Innovation Killer
If your idea involves technology or services that address protected health information, become a HIPAA savant as soon as possible. The good news is that if you can effectively navigate the HIPAA challenge, you will have an advantage over your competitors.
Pure ‘Tech’ Plays Are Difficult
If you want to try to build the next killer app for healthcare and hope it will go viral, good luck. Based on my experience, it is difficult to get market traction with a pure technology offering. The strategy with a higher likelihood of success is to provide services with a technology platform that supports those services. As a provider of a service, you can provide immediate value to the customer and become “sticky” as you build your business (and software).
Enjoy the Journey, No Matter What
At first, you will be propelled by irrational exuberance and a passion for the greatness of your idea. That’s not only a good thing, it’s a requirement. But becoming a successful entrepreneur is a heavy haul down a long road of hard work and execution. Enjoying the journey is crucial since, beyond that, there are no guarantees. But life is short, so maybe you also value a career with no regrets. Take a chance and enjoy the ride.
Being a physician entrepreneur is not for everyone. But for those who take the plunge, it can be one of the most fulfilling, exciting, and meaningful journeys one could imagine. TH
Author note: I’d like to thank Dr. Jason Stein and Joe Miller for their helpful comments on this column.
If you are a hospitalist, you are an entrepreneur almost by definition. All hospitalists are continuously engaged in improving the hospital experience for our patients. For some of us, the inner entrepreneur may grow to a point where we seriously consider a part-time or full-time commitment to an entrepreneurial dream. Combining our years of immersion in hospital patient care with an inventive streak can be a potent recipe for an innovative product or service idea.
It may be that the burgeoning startup scene in healthcare has inspired your dream. From coast to coast, there are startup incubators such as Rock Health, Healthbox, Blueprint Health, StartUp Health, Health Wildcatters, The Iron Yard, and TechSpring. These outfits support entrepreneurs with mentorship, funding, workspace, and/or information, such as how to deal with HIPAA or the FDA. Most of us have had at least a passing fascination with Steve Jobs–type characters, individuals who changed the world through their vision and force of will or who just seemed to enjoy a freedom that those who work for “The Man” will never know.
A few years ago, I caught the entrepreneurial bug. Initially, I continued with my day job and worked nights and weekends on my side project. Eventually, I made the leap to work full-time at an early-stage healthcare company. Since then, I’ve spent a lot of time trying to improve my new practice as a full-time entrepreneur, working as hard as ever, trying to be an effective innovator. Every day seems to bring new lessons—some more hard-earned than others—and there’s a lifetime of them still ahead. I’d like to share some of the insights I have learned on this journey. By the way, I still make time for patient care since that remains a priority for me.
Patience Is a Virtue, but Persistence and Positivity Count Even More
As Henry David Thoreau wrote, “Go confidently in the direction of your dreams.” Don’t postpone action indefinitely just because there are obstacles. Stop making excuses, make a start, and build momentum every day. Commit.
Becoming an entrepreneur is a long-term effort fueled by dedication and optimism, but first you have to make a start. You can’t win if you don’t play.
Action and Learning Matter More than Ideation
Start with your idea and a rough plan, but above all, believe in yourself, especially your ability to problem-solve. Many of the qualities that have fueled our success as physicians—precision, thoughtfulness, error aversion, and compulsiveness—might be constraints in a startup environment. Startups are hostile places for perfectionists and those who require complete information before proceeding. Have a bias for action and become comfortable with ambiguity. Entrepreneurs turn little things into big things by making progress every day.
Perhaps contrary to what we learn as physicians, entrepreneurs understand progress is measured more by authentic learning than by getting particular results. Entrepreneurs must quickly learn how to fail. In fact, progress often resembles multiple experiments that allow you to fail (and learn) faster. For entrepreneurs, perfection truly is the enemy of the good.
Learn, make adjustments, and progress will follow.
Guidance Is More Valuable than Money
Commercializing an idea is a challenging proposition. First-timers need advice, support, and help. For advice, find a mentor who has successfully launched a startup. Most of the successful people I know have had the wisdom or good fortune to have a mentor to provide guidance.
Startup incubators can be another source of support. Nearly all large cities and many medium and small cities now have business incubators or accelerators. Attend an event and get involved. They will provide many of the tools you will need to get started.
There are lots of opportunities for innovation in healthcare. But commercializing an idea will be one of the most challenging things you’ll ever do. Surround yourself with people who have skills that complement yours. Physician entrepreneurs need to be part of a viable team.
Sell, Sell, Sell
In business, as in life, “we’re all in sales.” We sell our ideas, our work product, ourselves. Even as physicians we have to sell patients and colleagues on our thought processes to be successful. Successful entrepreneurs are comfortable selling and put their best foot forward when trying to recruit a resource or persuade a potential customer.
Conflicts of Interest
“There is no interest without conflict.” If you look hard enough, you’ll see that we all have conflicts of interest. The key is to recognize them and disclose them. Of course, there are certain conflicts that are deal breakers. They must be avoided. If you remain employed, most of them are spelled out in your employer’s conflict of interest and intellectual property policies.
HIPAA Is an Innovation Killer
If your idea involves technology or services that address protected health information, become a HIPAA savant as soon as possible. The good news is that if you can effectively navigate the HIPAA challenge, you will have an advantage over your competitors.
Pure ‘Tech’ Plays Are Difficult
If you want to try to build the next killer app for healthcare and hope it will go viral, good luck. Based on my experience, it is difficult to get market traction with a pure technology offering. The strategy with a higher likelihood of success is to provide services with a technology platform that supports those services. As a provider of a service, you can provide immediate value to the customer and become “sticky” as you build your business (and software).
Enjoy the Journey, No Matter What
At first, you will be propelled by irrational exuberance and a passion for the greatness of your idea. That’s not only a good thing, it’s a requirement. But becoming a successful entrepreneur is a heavy haul down a long road of hard work and execution. Enjoying the journey is crucial since, beyond that, there are no guarantees. But life is short, so maybe you also value a career with no regrets. Take a chance and enjoy the ride.
Being a physician entrepreneur is not for everyone. But for those who take the plunge, it can be one of the most fulfilling, exciting, and meaningful journeys one could imagine. TH
Author note: I’d like to thank Dr. Jason Stein and Joe Miller for their helpful comments on this column.
Tackling the Readmissions Problem
Virtually every hospital system in the country deals with the challenge of readmissions, especially 30-day readmissions, and it’s only getting worse. “With the changes in healthcare and length of stay becoming shorter, patients are being discharged sicker than they used to be,” says Kevin Tolliver, MD, FACP, of Sidney & Lois Eskenazi Hospital Outpatient Care Center. “At our large public hospital system in Indianapolis, we designed an Internal Medicine Transitional Care Practice with the goal of decreasing readmission rates.”
Since October 2015, patients without a primary care doctor and those with a high LACE score have been referred to the new Transitional Care clinic. The first step: While still hospitalized, they meet briefly with Dr. Tolliver, who tells them, “‘You’re a candidate for this hospital follow-up clinic; this is why we think you would benefit.’ Patients, universally, are very thankful and eager to come.” The patients have their follow-up appointment scheduled before they are discharged.
At that appointment, the goal is to head off anything that would put them at risk for readmission. “We have a pharmacy, social workers, substance abuse counselors, diabetes educators—it’s one-stop shopping to address their needs,” Dr. Tolliver says. “Once we ensure that they’re not at risk for readmission, we help them get back to their primary care doctor or help them get one.”
Data for the clinic’s first four months show those patients who met with Dr. Tolliver before leaving the hospital were 50% more likely to keep their hospital follow-up visit. “That’s significant, particularly for us, because we take care of an indigent population; the no-show rate is usually our biggest challenge,” he says. Patients who were seen had a 30-day readmission rate of about 13.9%, while those who qualified but weren’t seen had a readmission rate of 21.8%.
“That has all kinds of positive consequences: less frustration for providers and patients and huge financial implications for the hospital system as well,” Dr. Tolliver says. “That there are these new models of post-discharge clinics out there and that there’s data suggesting that they work, particularly for a high-risk group of people, I think is worth knowing.”
Virtually every hospital system in the country deals with the challenge of readmissions, especially 30-day readmissions, and it’s only getting worse. “With the changes in healthcare and length of stay becoming shorter, patients are being discharged sicker than they used to be,” says Kevin Tolliver, MD, FACP, of Sidney & Lois Eskenazi Hospital Outpatient Care Center. “At our large public hospital system in Indianapolis, we designed an Internal Medicine Transitional Care Practice with the goal of decreasing readmission rates.”
Since October 2015, patients without a primary care doctor and those with a high LACE score have been referred to the new Transitional Care clinic. The first step: While still hospitalized, they meet briefly with Dr. Tolliver, who tells them, “‘You’re a candidate for this hospital follow-up clinic; this is why we think you would benefit.’ Patients, universally, are very thankful and eager to come.” The patients have their follow-up appointment scheduled before they are discharged.
At that appointment, the goal is to head off anything that would put them at risk for readmission. “We have a pharmacy, social workers, substance abuse counselors, diabetes educators—it’s one-stop shopping to address their needs,” Dr. Tolliver says. “Once we ensure that they’re not at risk for readmission, we help them get back to their primary care doctor or help them get one.”
Data for the clinic’s first four months show those patients who met with Dr. Tolliver before leaving the hospital were 50% more likely to keep their hospital follow-up visit. “That’s significant, particularly for us, because we take care of an indigent population; the no-show rate is usually our biggest challenge,” he says. Patients who were seen had a 30-day readmission rate of about 13.9%, while those who qualified but weren’t seen had a readmission rate of 21.8%.
“That has all kinds of positive consequences: less frustration for providers and patients and huge financial implications for the hospital system as well,” Dr. Tolliver says. “That there are these new models of post-discharge clinics out there and that there’s data suggesting that they work, particularly for a high-risk group of people, I think is worth knowing.”
Virtually every hospital system in the country deals with the challenge of readmissions, especially 30-day readmissions, and it’s only getting worse. “With the changes in healthcare and length of stay becoming shorter, patients are being discharged sicker than they used to be,” says Kevin Tolliver, MD, FACP, of Sidney & Lois Eskenazi Hospital Outpatient Care Center. “At our large public hospital system in Indianapolis, we designed an Internal Medicine Transitional Care Practice with the goal of decreasing readmission rates.”
Since October 2015, patients without a primary care doctor and those with a high LACE score have been referred to the new Transitional Care clinic. The first step: While still hospitalized, they meet briefly with Dr. Tolliver, who tells them, “‘You’re a candidate for this hospital follow-up clinic; this is why we think you would benefit.’ Patients, universally, are very thankful and eager to come.” The patients have their follow-up appointment scheduled before they are discharged.
At that appointment, the goal is to head off anything that would put them at risk for readmission. “We have a pharmacy, social workers, substance abuse counselors, diabetes educators—it’s one-stop shopping to address their needs,” Dr. Tolliver says. “Once we ensure that they’re not at risk for readmission, we help them get back to their primary care doctor or help them get one.”
Data for the clinic’s first four months show those patients who met with Dr. Tolliver before leaving the hospital were 50% more likely to keep their hospital follow-up visit. “That’s significant, particularly for us, because we take care of an indigent population; the no-show rate is usually our biggest challenge,” he says. Patients who were seen had a 30-day readmission rate of about 13.9%, while those who qualified but weren’t seen had a readmission rate of 21.8%.
“That has all kinds of positive consequences: less frustration for providers and patients and huge financial implications for the hospital system as well,” Dr. Tolliver says. “That there are these new models of post-discharge clinics out there and that there’s data suggesting that they work, particularly for a high-risk group of people, I think is worth knowing.”
Not All EDs Adopt Interventions to Improve Flow, Decrease Crowding
Clinical question: What is the relationship between crowding in the ED and the number of interventions adopted by the ED to address this?
Background: ED crowding results in long waits, prolonged lengths of stay, and delays in providing treatments, which can result in adverse events. Numerous interventions, including bedside registration, ED observation units, fast track, bed czar, surgical schedule smoothing, and pooled nursing, have been implemented to reduce crowding.
Study design: Retrospective, cross-sectional analysis.
Setting: U.S. hospitals in the National Hospital Ambulatory Medical Care Survey (NHAMCS).
Synopsis: From 2007 to 2010, an average of 341 hospitals per year were analyzed from the NHAMCS, representing 139,502 patient encounters. This study evaluated the adoption of nine crowding interventions at the emergency department level (bedside registration, electronic dashboard, RFID tracking, etc.) and eight crowding interventions at the hospital level (bed czar, pooled nursing, full-capacity protocol, board patients in inpatient hallways, etc.).
Bedside registration, electronic dashboard, RFID tracking, bed census, pooled nursing, full-capacity protocol, and boarding patients in the hallway had the highest statistically significant increases in adoption over the study period.
The average number of interventions adopted increased to 6.6 from 5.2, and more-crowded EDs adopted a greater number of interventions than less-crowded EDs. However, in the most-crowded quartile of EDs, 19% did not use bedside registration, and 94% did not use surgical schedule smoothing.
Given that this study is a retrospective, cross-sectional study, it is difficult to determine causality.
Bottom line: More interventions are being adopted by EDs and hospitals to decrease ED crowding, but several of the busiest EDs and hospitals have room for improvement.
Citation: Warner LS, Pines JM, Chambers JG, Schuur JD. The most crowded US hospital emergency departments did not adopt effective interventions to improve flow, 2007–10. Health Aff. 2015;34(12):2151-2159.
Clinical question: What is the relationship between crowding in the ED and the number of interventions adopted by the ED to address this?
Background: ED crowding results in long waits, prolonged lengths of stay, and delays in providing treatments, which can result in adverse events. Numerous interventions, including bedside registration, ED observation units, fast track, bed czar, surgical schedule smoothing, and pooled nursing, have been implemented to reduce crowding.
Study design: Retrospective, cross-sectional analysis.
Setting: U.S. hospitals in the National Hospital Ambulatory Medical Care Survey (NHAMCS).
Synopsis: From 2007 to 2010, an average of 341 hospitals per year were analyzed from the NHAMCS, representing 139,502 patient encounters. This study evaluated the adoption of nine crowding interventions at the emergency department level (bedside registration, electronic dashboard, RFID tracking, etc.) and eight crowding interventions at the hospital level (bed czar, pooled nursing, full-capacity protocol, board patients in inpatient hallways, etc.).
Bedside registration, electronic dashboard, RFID tracking, bed census, pooled nursing, full-capacity protocol, and boarding patients in the hallway had the highest statistically significant increases in adoption over the study period.
The average number of interventions adopted increased to 6.6 from 5.2, and more-crowded EDs adopted a greater number of interventions than less-crowded EDs. However, in the most-crowded quartile of EDs, 19% did not use bedside registration, and 94% did not use surgical schedule smoothing.
Given that this study is a retrospective, cross-sectional study, it is difficult to determine causality.
Bottom line: More interventions are being adopted by EDs and hospitals to decrease ED crowding, but several of the busiest EDs and hospitals have room for improvement.
Citation: Warner LS, Pines JM, Chambers JG, Schuur JD. The most crowded US hospital emergency departments did not adopt effective interventions to improve flow, 2007–10. Health Aff. 2015;34(12):2151-2159.
Clinical question: What is the relationship between crowding in the ED and the number of interventions adopted by the ED to address this?
Background: ED crowding results in long waits, prolonged lengths of stay, and delays in providing treatments, which can result in adverse events. Numerous interventions, including bedside registration, ED observation units, fast track, bed czar, surgical schedule smoothing, and pooled nursing, have been implemented to reduce crowding.
Study design: Retrospective, cross-sectional analysis.
Setting: U.S. hospitals in the National Hospital Ambulatory Medical Care Survey (NHAMCS).
Synopsis: From 2007 to 2010, an average of 341 hospitals per year were analyzed from the NHAMCS, representing 139,502 patient encounters. This study evaluated the adoption of nine crowding interventions at the emergency department level (bedside registration, electronic dashboard, RFID tracking, etc.) and eight crowding interventions at the hospital level (bed czar, pooled nursing, full-capacity protocol, board patients in inpatient hallways, etc.).
Bedside registration, electronic dashboard, RFID tracking, bed census, pooled nursing, full-capacity protocol, and boarding patients in the hallway had the highest statistically significant increases in adoption over the study period.
The average number of interventions adopted increased to 6.6 from 5.2, and more-crowded EDs adopted a greater number of interventions than less-crowded EDs. However, in the most-crowded quartile of EDs, 19% did not use bedside registration, and 94% did not use surgical schedule smoothing.
Given that this study is a retrospective, cross-sectional study, it is difficult to determine causality.
Bottom line: More interventions are being adopted by EDs and hospitals to decrease ED crowding, but several of the busiest EDs and hospitals have room for improvement.
Citation: Warner LS, Pines JM, Chambers JG, Schuur JD. The most crowded US hospital emergency departments did not adopt effective interventions to improve flow, 2007–10. Health Aff. 2015;34(12):2151-2159.
Close INR Monitoring Might Prevent Adverse Events
Clinical question: What is the appropriate frequency of INR monitoring in the hospital and its relationship to the risk of over-anticoagulation and warfarin-related adverse events?
Background: Warfarin use is a common cause of adverse drug events in hospitalized patients due to narrow therapeutic windows, drug interactions, and variability of metabolism. Current guidelines, including those by the American College of Chest Physicians, do not provide recommendations on how often to monitor INR or adjust warfarin dosing in the hospital.
Study design: Retrospective cohort.
Setting: Hospitalized patients included in the Medicare Patient Safety Monitoring System.
Synopsis: The study included 14,217 adult patients ≥18 years of age from the Medicare Patient Safety Monitoring System admitted from 2009 to 2013 with pneumonia, acute cardiac disease (myocardial infarction or congestive heart failure), or surgery and taking warfarin. Of those, 1,055 (7.4%) developed a warfarin-associated adverse event (bleeding, drop in hematocrit ≥3, hematoma, death, intracranial bleeding, or cardiac arrest). Patients admitted for acute cardiac disease (acute myocardial infarction or heart failure) or surgery on warfarin for ≥3 days but not monitored for ≥2 days had more warfarin-associated adverse events (OR 1.48; 95% CI, 1.02–2.17), but this association was not true in pneumonia patients. Cardiac and pneumonia patients with ≥1 day without INR being measured had higher rates of INR ≥6.0 (OR 1.61; 95% CI, 1.07–2.41, and OR 1.92, 95% CI, 1.36–2.71, respectively). A single-day rise in INR ≥0.9 had a likelihood ratio of 4.2 in predicting subsequent INR ≥6.0.
Bottom line: Frequent monitoring of INR may decrease warfarin-associated adverse events in hospitalized patients.
Citation: Metersky ML, Eldridge N, Wang Y, et al. Predictors of warfarin-associated adverse events in hospitalized patients: opportunities to prevent harm. J Hosp Med. 2016;11(4):276-282.
Short Take
CDC Guidelines on Prescribing Opioids
New CDC guidelines for chronic pain management stress the importance of non-pharmacologic (physical therapy, etc.) and non-opioid therapy (NSAIDs, etc.), using opioid therapy only if the expected benefits outweigh the risks.
Citation: CDC. CDC guideline for prescribing opioids for chronic pain. Available at: http://www.cdc.gov/drugoverdose/prescribing/guideline.html. Published March 16, 2016. Accessed April 8, 2016.
Clinical question: What is the appropriate frequency of INR monitoring in the hospital and its relationship to the risk of over-anticoagulation and warfarin-related adverse events?
Background: Warfarin use is a common cause of adverse drug events in hospitalized patients due to narrow therapeutic windows, drug interactions, and variability of metabolism. Current guidelines, including those by the American College of Chest Physicians, do not provide recommendations on how often to monitor INR or adjust warfarin dosing in the hospital.
Study design: Retrospective cohort.
Setting: Hospitalized patients included in the Medicare Patient Safety Monitoring System.
Synopsis: The study included 14,217 adult patients ≥18 years of age from the Medicare Patient Safety Monitoring System admitted from 2009 to 2013 with pneumonia, acute cardiac disease (myocardial infarction or congestive heart failure), or surgery and taking warfarin. Of those, 1,055 (7.4%) developed a warfarin-associated adverse event (bleeding, drop in hematocrit ≥3, hematoma, death, intracranial bleeding, or cardiac arrest). Patients admitted for acute cardiac disease (acute myocardial infarction or heart failure) or surgery on warfarin for ≥3 days but not monitored for ≥2 days had more warfarin-associated adverse events (OR 1.48; 95% CI, 1.02–2.17), but this association was not true in pneumonia patients. Cardiac and pneumonia patients with ≥1 day without INR being measured had higher rates of INR ≥6.0 (OR 1.61; 95% CI, 1.07–2.41, and OR 1.92, 95% CI, 1.36–2.71, respectively). A single-day rise in INR ≥0.9 had a likelihood ratio of 4.2 in predicting subsequent INR ≥6.0.
Bottom line: Frequent monitoring of INR may decrease warfarin-associated adverse events in hospitalized patients.
Citation: Metersky ML, Eldridge N, Wang Y, et al. Predictors of warfarin-associated adverse events in hospitalized patients: opportunities to prevent harm. J Hosp Med. 2016;11(4):276-282.
Short Take
CDC Guidelines on Prescribing Opioids
New CDC guidelines for chronic pain management stress the importance of non-pharmacologic (physical therapy, etc.) and non-opioid therapy (NSAIDs, etc.), using opioid therapy only if the expected benefits outweigh the risks.
Citation: CDC. CDC guideline for prescribing opioids for chronic pain. Available at: http://www.cdc.gov/drugoverdose/prescribing/guideline.html. Published March 16, 2016. Accessed April 8, 2016.
Clinical question: What is the appropriate frequency of INR monitoring in the hospital and its relationship to the risk of over-anticoagulation and warfarin-related adverse events?
Background: Warfarin use is a common cause of adverse drug events in hospitalized patients due to narrow therapeutic windows, drug interactions, and variability of metabolism. Current guidelines, including those by the American College of Chest Physicians, do not provide recommendations on how often to monitor INR or adjust warfarin dosing in the hospital.
Study design: Retrospective cohort.
Setting: Hospitalized patients included in the Medicare Patient Safety Monitoring System.
Synopsis: The study included 14,217 adult patients ≥18 years of age from the Medicare Patient Safety Monitoring System admitted from 2009 to 2013 with pneumonia, acute cardiac disease (myocardial infarction or congestive heart failure), or surgery and taking warfarin. Of those, 1,055 (7.4%) developed a warfarin-associated adverse event (bleeding, drop in hematocrit ≥3, hematoma, death, intracranial bleeding, or cardiac arrest). Patients admitted for acute cardiac disease (acute myocardial infarction or heart failure) or surgery on warfarin for ≥3 days but not monitored for ≥2 days had more warfarin-associated adverse events (OR 1.48; 95% CI, 1.02–2.17), but this association was not true in pneumonia patients. Cardiac and pneumonia patients with ≥1 day without INR being measured had higher rates of INR ≥6.0 (OR 1.61; 95% CI, 1.07–2.41, and OR 1.92, 95% CI, 1.36–2.71, respectively). A single-day rise in INR ≥0.9 had a likelihood ratio of 4.2 in predicting subsequent INR ≥6.0.
Bottom line: Frequent monitoring of INR may decrease warfarin-associated adverse events in hospitalized patients.
Citation: Metersky ML, Eldridge N, Wang Y, et al. Predictors of warfarin-associated adverse events in hospitalized patients: opportunities to prevent harm. J Hosp Med. 2016;11(4):276-282.
Short Take
CDC Guidelines on Prescribing Opioids
New CDC guidelines for chronic pain management stress the importance of non-pharmacologic (physical therapy, etc.) and non-opioid therapy (NSAIDs, etc.), using opioid therapy only if the expected benefits outweigh the risks.
Citation: CDC. CDC guideline for prescribing opioids for chronic pain. Available at: http://www.cdc.gov/drugoverdose/prescribing/guideline.html. Published March 16, 2016. Accessed April 8, 2016.
Metal-on-Metal Hip Replacement Devices Implanted after 2006 have a High Revision Rate
NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.
"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.
To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.
Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.
A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean
followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.
A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.
In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.
The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.
The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.
Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.
Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."
He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."
Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.
She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."
Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."
With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."
The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.
NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.
"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.
To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.
Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.
A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean
followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.
A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.
In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.
The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.
The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.
Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.
Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."
He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."
Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.
She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."
Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."
With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."
The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.
NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.
"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.
To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.
Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.
A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean
followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.
A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.
In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.
The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.
The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.
Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.
Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."
He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."
Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.
She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."
Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."
With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."
The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.